Drug acronyms

• WPADP - ISBT Working Party on Automation and Data Processing

• NATAG - North American Technical Advisory Group

• § - section – shorthand symbol used to designate a section in a legal document; as in §201(m) of the FD&C Act.

• §§ - sections – shorthand symbol used to designate sections in a legal document; as in §§201(m), 301(k) of the FD&C Act.

• 1932 - FDA form for veterinary adverse drug reaction, lack of effectiveness, product defect report--mandatory

• 1932a - FDA form for veterinary adverse drug reaction, lack of effectiveness, product defect report--voluntary

• 2301 - FDA form for transmittal of periodic reports and promotional material for new animal drugs

• 348 - FDA form for sponsored travel

• 3500 - FDA form for voluntary reporting of adverse events

• 3500A - FDA form for mandatory reporting of adverse events

• 356V - FDA form for new animal drug application

• 3Rs - recruitment and relocation bonuses and retention allowances

• 406B - Section of the FDA Modernization Act dealing with getting feedback from our stakeholders

• 482 - FDA form for notice of inspection

• 483 - FDA form used as a written notice of deficiencies found in inspections

• 505(b)(2) - A new drug application that contains full reports of investigations of safety and effectiveness but where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.

• 510(k) - section of the Food, Drug, and Cosmetic Act that deals with premarket notification

• A-V - arteriovenous

• A-VO2 - arteriovenous oxygen

• A/L - annual leave

• A2LA - American Association for Laboratory Accreditation

• AAA - abdominal aortic aneurysm

• AAALAC - Association for Assessment and Accreditation of Laboratory Animal Care International

• AAAP - American Association of Avian Pathologists

• AAAS - American Association for the Advancement of Science

• AABB - American Association of Blood Banks

• AABP - American Association of Bovine Practitioners

• AACR - American Association for Cancer Research

• AADA - abbreviated antibiotic drug application

• AAEP - American Association of Equine Practitioners

• AAFCO - Association of American Feed Control Officials

• AAFP - American Academy of Family Physicians.

• AAHA - American Animal Hospital Association

• AAI - American Association of Immunologists

• AALAS - American Association for Laboratory Animal Science

• AAMI - American Association for Medical Instrumentation

• AANN - American Association of Neurosciences Nurses

• AANS - American Association of Neurological Surgeons

• AAO - American Academy of Ophthalmology.

• AAP - American Academy of Pediatrics.

• AAP - American Academy of Peridontology.

• AAPHP - American Association of Public Health Physicians

• AAPM - American Association of Physicists in Medicine

• AAPS - American Association of Pharmaceutical Scientists

• AAR - after action review

• AARP - American Association of Retired Persons

• AAS - acute abdominal series

• AASP - American Association of Swine Practitioners

• AASRP - American Association of Small Ruminant Practitioners

• AATB - American Association of Tissue Banks

• AAVLD - American Association of Veterinary Laboratory Diagnosticians

• AAVMC - Association of American Veterinary Medical Colleges

• AAVPT - American Academy of Veterinary Pharmacology and Therapeutics

• AB (CDRH) - Analysis Branch (CDRH)

• ABC - America’s Blood Centers

• ABC - American Blood Commission

• ABE - adverse biologic experience

• ABG - arterial blood gas

• ABI - Automated Broker Interface (U.S. Customs)

• Abifarma - Brazilian Association of the Pharmaceutical Industry

• ABM - application briefing meeting

• ABPI - Association of the British Pharmaceutical Industry

• ABRA - American Blood Resource Association

• AC - Advisory Committee

• ACB (CDRH) - Accreditation and Certification Branch (CDRH)

• ACBSA - Advisory Committee on Blood Safety and Availability (HHS)

• ACC - RCHSA (Radiation Control for Health and Safety Act) accession number (ORA AofC code)

• ACCME - Accreditation Council for Continuing Medical Education

• ACCP - American College of Clinical Pharmacology

• ACE - adverse clinical event

• ACE - angiotensin-converting enzyme

• ACE - Association of Clinical Embryologists

• ACE - Automated Commercial Environment (Customs and Border Protection)

• ACED - Advisory Committee for Employees with Disabilities

• ACEP - American College of Emergency Physicians

• ACF - Administration for Children and Families (DHHS)

• ACG - American College of Gastroenterology

• ACGME - Accreditation Council for Graduate Medical Education

• ACIL - American Council of Independent Laboratories

• ACIP - Advisory Committee on Immunization Practices (CDC)

• ACLA - American Clinical Laboratory Association

• ACLAD - American Committee on Laboratory Animal Diseases

• ACLAM - American College of Laboratory Animal Medicine

• ACMP - American College of Medical Physics

• ACOL - acceptable carry-over limit

• ACP - American College of Physicians

• ACPE - Accreditation Council for Pharmacy Education

• ACPM - American College of Preventive Medicine

• ACR - American College of Radiology

• ACRA (ORA) - Associate Commissioner for Regulatory Affairs (ORA)

• ACRPI - Association of Clinical Research for the Pharmaceutical Industry

• ACS - American Chemical Society

• ACS - Automated Commercial System (U.S. Customs)

• ACS (CBER) - Analytical Chemistry Staff (CBER)

• ACS (CDER) - Advisors and Consultants Staff (CDER)

• ACSM - American College of Sports Medicine

• ACT - AIDS clinical trials

• ACT - applied clinical trials

• ACTB (NCTR) - Analytical Chemical Techniques Branch (NCTR)

• ACTH - adrenocorticotropic hormone

• ACTIS - Aids Clinical Trials Information Service

• ACUS - Administrative Conference of the United States

• ACWA - Administrative Careers with America (OPM)

• AD - action due

• ad lib - as much as needed

• ADA - American Dental Association

• ADA - American Diabetes Association

• ADA - Americans with Disabilities Act of 1990

• ADAA - Animal Drug Availability Act of 1996

• ADaM - analysis dataset model (CDISC)

• ADAMHA - Alcohol, Drug Abuse and Mental Health Administration (now SAMHSA)

• ADCOM - advisory committee

• ADE - adverse drug event

• ADE - adverse drug experience

• ADE/ADER - Adverse Drug Experience/Adverse Drug Experience Report

• ADEC - Australian Drug Evaluation Committee

• AdEERS - Adverse Event Expidited Reporting System (NCI)

• ADH - antidiuretic hormone

• ADHD - Attention Deficit Hyperactivity Disorder

• ADI - acceptable daily intake

• ADIMS - Automated Drug Information Management System

• ADME - absorption, distribution, metabolism, and excretion

• ADMIA (CBER) - Associate Director for Medical and International Affairs (CBER)

• ADP - automated data processing

• ADP (CBER) - Associate Director for Policy (CBER)

• ADR - adverse drug reaction

• ADR - adverse drug report

• ADR (CBER) - Associate Director for Research (CBER)

• ADRA - Administrative Dispute Resolution Act

• ADRA - Associate Director of Regulatory Affairs

• ADRAC - Adverse Drug Reactions Advisory Committee (TGA)

• ADRM (CBER) - Associate Director for Review Management (CBER)

• ADRP - Association of Donor Recruitment Professionals

• ADRS - Adverse Drug Reporting System

• ADSA - American Dairy Science Association

• ADUFA - Animal Drug User Fee Act of 2003

• AdvaMed - Advanced Medical Technology Association

• AE - adverse event

• AE - approvable

• AEA - actual expense allowance

• AED - Automated External Defibrillators

• AER - adverse event report

• AERS - Adverse Event Reporting System

• AF - administrative file

• AF - atrial fibrillation

• AFAB - absorbable fibrin adhesive bandage

• AFDO - Association of Food and Drug Officials

• AFGE - American Federation of Government Employees

• AFIA - American Feed Industry Association

• AFIP - Armed Forces Institute of Pathology (DoD)

• AFP - alpha-fetoprotein

• AFSS - Animal Feed Safety System

• AGD - action goal date

• AGDUFA - Animal Generic Drug User Fee Act

• AGRICOLA - Agricultural Online Access (USDA)

• AHA - American Hospital Association

• AHCPR - Agency for Health Care Policy and Research (now AHRQ)

• AHF - antihemophilic factor

• AHFS - American Hospital Formulary Service

• AHI - Animal Health Institute

• AHIC - American Health Information Community

• AHRQ - Agency for Healthcare Quality and Research (formerly AHCPR) (DHHS)

• AHU - air handling unit

• AICRC - Association of Independent Clinical Research Contractors (UK)

• AID - Agency for International Development

• AIDS - acquired immune deficiency syndrome

• AIM - active ingredient manufacturer

• AIM - Association for Automatic Identification and Mobility

• AIMBE - American Institute for Medical and Biological Engineering

• AIMDD - active implantable medical device directive

• AIMS - Agency Information Management System

• AIN - food additive identification number (ORA AofC code)

• AIP - abbreviated inspection system

• AIP - application integrity policy

• AIRIO - Agency Intramural Research Integrity Officer (NIH)

• AIS - automated information system

• aka - also known as

• AL - annual leave

• ALARA - as low as reasonably achievable

• ALFB (CBER) - Acess Litigation and FOI Branch (CBER)

• ALFOI (CBER) - Access Litigation and Freedom of Information Branch (CBER)

• ALJ - administrative law judge

• ALJ (OC) - Office of the Administrative Law Judge (OC)

• ALL - acute lymphocytic leukemia

• alt - alanine aminotransferase

• AMA - Agricultural Marketing Act of 1946 (USDA)

• AMA - American Medical Association

• AMA-DE - American Medical Association's Drug Evaluations

• AMB (CDRH) - Adminstrative Management Branch (CDRH)

• AMDUCA - Animal Medicinal Drug Use Clarification Act

• AME - absorption, metabolism, excretion

• AMF - administrative management of files

• AmFAR - American Foundation for AIDS Research

• AMG - Arzeneimittelgesetz (West Germany drug law)

• AMHPS - Association of Minority Health Professionals Schools

• AMI - acute myocardial infarction

• AMI - American Meat Institute

• AML - acute myelogenous leukemia

• AMP - average manufacturer price

• AMPI - Associated Milk Producers, Inc.

• AMR - Antimicrobial Resistance

• AMS - Agricultural Marketing Service (USDA)

• AMS - aseptic meningitis syndrome

• AMT (OC) - Asset Management Team (OC)

• ANA - abbreviated new animal drug number (ORA AofC code)

• ANA - antinuclear antibody

• ANADA - abbreviated new animal drug application

• ANCOVA - analysis of covariance

• ANCOVA - analysis of covariance

• AND - abbreviated new drug application number (ORA AofC code)

• ANDA - abbreviated new drug application

• ANOVA - analysis of variance

• ANPR - advance notice of proposed rulemaking

• ANPRM - advanced notice of proposed rule making

• ANRC - American National Red Cross

• ANSI - American National Standards Institute

• ANZFA - Australia New Zealand Food Authority

• AO - administrative officer

• AoA - Administration on Aging (DHHS)

• AOAC - Association of Official Analytical Chemists

• AOB (OC) - Accounting Operations Branch (OC)

• AODM - adult onset diabetes mellitus

• AofC - affirmation of compliance codes (ORA)

• AOPC - Agency/Organization Program Coordinator

• APA - Administrative Procedures Act

• APAC - Allergenic Products Advisory Committee (CBER)

• apap - N-acetyl-para-amino-phenol

• APBI - Association of the British Pharmaceutical Industry

• APEC - Asia-Pacific Economic Cooperation Council

• APhA - American Pharmaceutical Association

• APHA - American Public Health Association

• APHIS - Animal and Plant Health Inspection Service (USDA)

• APHL - Association of Public Health Laboratories

• API - active pharmaceutical ingredient

• APIC - Active Pharmaceutical Ingredients Committee of CEFIC (European Chemical Industry Council)

• APIFARMA - Association of the Portuguese Pharmaceutical Industries

• APLB (CBER) - Advertising and Promotional Labeling Branch (CBER)

• APR - annual product review

• APSB (OC) - Accounting Policy and Systems Branch (OC)

• APTF - Application Policy Task Force

• APUA - Alliance for Prudent Use of Antibiotics

• AQL - acceptable quality level

• AR - approvable letter

• ARAB (OC) - Accounting Reports and Analysis Branch (OC)

• ARB - angiotensin receptor blocker

• ARC - American Red Cross

• ARCH - Administrative Resources Core Hub (CFSAN)

• ARCRT - American Registry of Clinical Radiography Technologists

• ARDB (CDRH) - Anesthesiology and Respiratory Devices Branch (CDRH)

• ARDS - acute respiratory distress syndrome

• ARENA - Applied Research Ethics National Association

• ARF - acute renal failure

• ARIES - Administrative Resources Information Exchange System

• ARL (ORA) - Arkansas Regional Laboratory (ORA)

• ARNet - Acquisition Reform Network

• ARPA - Advanced Research Projects Agency (DoD)

• ARRT - American Registry of Radiologic Technologists

• ARS - Acute Radiation Syndrome

• ARS - Advancing Regulatory Science

• ARS - Agricultural Research Service (USDA)

• ART - Architecture Review Team

• ART - assisted reproductive technology

• ART - assisted reproductive therapy

• ARTCA - Antimicrobial Regulations Technical Correction Act of 1998

• AS - aortic stenosis

• AS (CVM) - Administrative Staff (CVM)

• ASA - Acoustical Society of America

• ASA - American Society of Anesthesiologists

• ASA - American Statistical Association

• ASA - Americans for Safe Access

• ASA - aminosalicylic acid

• ASAP - Administrative Systems Automation Project

• ASAP - as soon as possible

• ASAS - American Society of Animal Science

• ASB (OC) - Accounting Services Branch (OC)

• ASB (OC) - Administrative Services Branch (OC)

• ASBPO - Armed Services Blood Program Office

• ASC - Advertising Standards Council (Canada)

• ASCII - American Standard Code for Information Interchange (computer files)

• ASCO - American Society for Clinical Oncology

• ASCP - American Society for Clinical Pathology

• ASCPT - American Society for Clinical Pharmacology and Therapeutics

• ASCVD - atherosclerotic cardiovascular disease

• ASD - atrial septal defect

• ASD (HD) - Assistant Secretary of Defense for Homeland Defense

• ASGE - American Society for Gastrointestinal Endoscopy

• ASHD - atherosclerotic heart disease

• ASHRAE - American Society of Heating, Refrigeration & Air Conditioning Engineers

• ASIA - American Sheep Industry Association

• ASICS - Application Specific Integrated Circuit(s)

• ASLAP - American Society of Laboratory Animal Practitioners

• ASM - American Society for Microbiology

• ASME - American Society of Mechanical Engineers

• ASPR - Assistant Secretary for Preparedness and Response (HHS)

• ASQ - American Society for Quality

• ASQC - American Society for Quality Control

• ASR - analyte specific reagent

• ASRM - American Society for Reproductive Medicine

• AST - aspartate aminotransferase

• ASTHO - Association of State and Territorial Health Officials

• ASTM - American Society for Testing and Materials

• AT (OC) - Acquisitions Team (OC)

• ATC - Anatomical Therapeutic Chemical (Drug Classification System) (WHO)

• ATF - Bureau of Alcohol, Tobacco and Firearms (U.S. Department of Justice)

• ATM - automatic teller machine

• ATPA - American Technology Pre-Eminence Act of 1991

• ATPM - Association of Teachers and Preventive Medicine

• ATS (CDER) - Applied Technologies Staff (CDER)

• ATSDR - Agency for Toxic Substances and Disease Registry (CDC)

• AUC - area under the curve

• AUSA - Assistant United States Attorney

• AV - atrioventricular

• AVA - American Veal Association

• AVDA - American Veterinary Distributors Association

• AVEG - AIDS Vaccine Evaluation Group

• AVMA - American Veterinary Medical Association

• AWC - adequate and well-controlled

• AWOL - absent without official leave

• AWP - average wholesale price

• AWS - alternate work schedule

• B&F (CVM) - Budget and Finance Team (CVM)

• BA/BE - bioavailability/bioequivalence

• BAC - billing agency code

• BaCON - Bacterial Contamination study

• BACPAC - bulk activities postapproval changes

• BAER - Brief Adverse Event Report Review (CDRH)

• BAH - Booz-Allen & Hamilton

• BAM - Bacteriological Analytical Manual

• BARC - Beltsville Area Agricultural Research Service (USDA)

• BARDA - Biomedical Advanced Research and Development Authority

• BARQA - British Association of Research Quality Assurance

• BARS (CDER) - Business Analysis and Reporting Staff (CDER)

• BASIS - Blood Availability and Safety Inventory System (HHS)

• BATF - Bureau of Alcohol, Tobacco and Firearms (U.S. Department of Justice)

• BB IND - biological investigational new drug

• BBB - bundle branch block

• BBR - Bureau of Biologics and Radiopharmaceuticals (Canada)

• BBS - bulletin board system

• BC/BS - Blue Cross and Blue Shield Association Health Insurance

• BCA - Blood Center of America

• BCAA - branched-chain amino acids

• BCB (CFSAN) - Bioanalytical Chemistry Branch (CFSAN)

• BCE - beneficial clinical event

• BCP - Bureau of Consumer Protection (FTC)

• BCPT - Breast Cancer Prevention Trial

• BDB - Biologic Devices Branch (CBER)

• BDB (CDRH) - Bacteriology Devices Branch (CDRH)

• BDLS - Blood Donor Locator Service

• BDPA - Bureau of Drug Policy and Administration (China)

• BDR - budget data request

• BDS - Bureau of Drug Surveillance (Canada)

• BDSS - Biologics Decision Support System

• BEA - Bureau of Economic Analysis (U.S. Department of Commerce)

• BECON - Bioengineering Consortium (NIH)

• BECS - blood establishment computer software

• BENS - Business Executives for National Security

• BEq - bioequivalence

• BER - Blood Establishment Registration and Product Listing (CBER)

• BEST - Biomonitoring of Environmental Status and Trends Program (U.S. Geological Survey)

• BFAC - Biologics Field Advisory Committee (CBER)

• BFAD - Bureau of Food & Drug Administration (Philippines)

• BfArM - Bundesinstitut fur Arzneimittel und Medizinprodukte (German Ministry of Health)

• BFL - Biologic establishment license number (ORA AofC code)

• BGA - Bundesgesundheitsamt (German Federal Health Office)

• BGH - bovine growth hormone

• BGMA - British Generic Manufacturer's Association

• BHPr - Bureau of Health Professions (HRSA)

• BIA - Bureau of Indian Affairs (U.S. Department of the Interior)

• BID - two times per day

• BIG - Blacks in Government

• BIMO - bioresearch monitoring

• BIMS - Biologic IND Management System

• BIND - biological investigational new drug

• BIO - Biotechnology Industry Association

• BIOB (CFSAN) - Biostatistics Branch (CFSAN)

• BIRA - The British Institute of Regulatory Affairs

• BIRAMS - Biologics Investigational and Related Applications Management System

• BIRS - Business Intelligence Reporting Solution

• BISTI - Biomedical Information Science and Technology Initiative (NIH)

• BISTIC - Biomedical Information Science and Technology Initiative Consortium (NIH)

• BIVAS - Body Image Visual Analog Scale

• BLA - biologics license application (CBER)

• BLM - Bureau of Land Management (U.S. Department of the Interior)

• BLS - biologics license supplement

• BLST (CFSAN) - Building and Laboratory Services Team (CFSAN)

• BLT - Blood Logging and Tracking System (CBER)

• BMB (CFSAN) - Bioanalytical Methods Branch (CFSAN)

• BMBL - Biosafety in Microbiological and Biomedical Laboratories (CDC)

• BMI - body mass index

• BMIS - Bioresearch Monitoring Information System (CDER)

• BMR - basal metabolic rate

• BMS (OC) - Broadcast Media Staff (OC)

• BNA - Bureau of National Affairs

• BNF - biotechnology notification file

• BOCB (CFSAN) - Biological and Organic Chemistry Branch (CFSAN)

• BOCF - baseline observation carried forward

• BOP - Boards of Pharmacy

• BOS (CBER) - Building Operations Staff (CBER)

• BOS-DO (ORA) - Boston (Massachusetts) District Office (ORA)

• BP - base pair

• BP - blood pressure

• BP - British Pharmacopoeia

• BPA - blanket purchase agreement

• BPA - Bureau of Pharmaceutical Assessment (Canada)

• BPAC - Blood Products Advisory Committee (CBER)

• BPB (CBER) - Blood and Plasma Branch (CBER)

• BPC - bulk pharmaceutical chemical

• BPC - Bureau of Policy and Coordination (Canada)

• BPCA - Best Pharmaceuticals for Children Act

• BPCI Act - Biologics Price Competition and Innovation Act of 2009

• BPD - biological product deviation

• BPD - broncho-pulmonary dysplasia

• BPE - bulk pharmaceutical excipient

• BPH - benign prostatic hyperplasia

• BPHC - Bureau of Primary Health Care (HRSA)

• BPL - biologic product license number (ORA AofC code)

• BPM - beats per minute

• BPR - business process re-engineering

• BPSRG - Biomedical and Pharmaceutical Sciences Research Group (UK)

• BPWG - Business Process Working Group

• BrAPP - British Association of Pharmaceutical Physicians

• BRCC - Biologics Research Coordinating Committee (CBER)

• BRFSS - Benavioral Risk Factor Surveillance System (CDC)

• BRMAC - Biological Response Modifiers Advisory Committee (CBER)

• BRMD - Bureau of Radiation and Medical Devices (Canada)

• BrMIS - Bioresearch Monitoring Information System

• BRMS - Biologics Regulatory Management System

• BSA - body surface area

• BSB (CFSAN) - Biotechnology Studies Branch (Chicago, Illinois) (CFSAN)

• BSC - biological safety cabinet

• BSC - Blood Safety Committee

• BSC - Business Service Centers

• BSD - Blood Service Directive

• BSE - bovine spongiform encephalopathy (mad cow disease)

• BSI - British Standards Institute

• BSL - Biosafety level

• BST - bovine somatotropin

• BSTS - Bundled Supplement Tracking System

• BsUFA - Biosimilar User Fee Act

• Bt - Bacillus thuringiensis

• BT - bioterrorism

• BT Act - Bioterrorism Act (Public Health Security and Bioterrorism Preparedness and Response Act of 2002)

• BTA - The Bioterroism Act of 2002

• BTCB (CBER) - Blood and Tissue Compliance Branch (CBER)

• BTD - Breakthrough Therapy Designation

• BTR - Blood and Tissue Registration System

• BUF-DO (ORA) - Buffalo (New York) District Office (ORA)

• BUN - blood urea nitrogen

• BUS - BIMS User Support Group

• BVB (CBER) - Bacterial Vaccine and Allergenic Products Branch (CBER)

• BVC - British Veterinary Codex

• BW - Body Weight

• BWM - basic workload measurement

• BWM - Biologics Workload Management

• BX - biopsy

• c - with

• C & R - corrections and removals

• C & S - culture and sensitivity

• C of A - certificate of analysis

• C-TPAT - Customs-Trade Partnership Against Terrorism

• C/CC - career or career conditional

• C3I - communications, command, control, and intelligence

• CA - Chemical Abstracts

• CA - committee assignment

• CA - competent authority (U.K.)

• CAAT - Center for Alternatives to Animal Testing (Johns Hopkins)

• CAB - conformity assessment body

• CAB (OC) - Computer Applications Branch (OC)

• CABE - corrective action(s) being effected

• CABG - coronary artery bypass graft

• caBIG - Cancer Biomedical Informatics Grid (NIH)

• CABP - community-acquired bacterial pneumonia

• CABs - conformity assessment bodies

• CAC - Carcinogenicity Assessment Committee (CDER)

• CACBERS - Committee for the Advancement of CBER Science

• CACTIS - Center ADP/TC Computer Tracking and Inventory System (CFSAN)

• CAD - control of automated processes

• CAD - coronary artery disease

• caDSR - Cancer Data Standards Repository (NCI)

• CAERS - CFSAN Adverse Event Reporting System

• CAERST (CFSAN) - CFSAN Adverse Event Reporting System Team

• CAFDAS - Committee for the Advancement of FDA Science

• cal - calorie

• CALA - computer-assisted license application

• CAN - common accounting number

• CANDA - computer assisted new drug application

• CAO - change of appointing office

• CAP - College of American Pathologists

• CAP - color additive petition

• CAP - corrective action plan

• CAPA - corrective and preventive action

• CAPD - continuous ambulatory peritoneal dialysis

• CAPLA - computer assisted product license application

• CAPLAR - Computer-Assisted Product License Application Review

• CAPRA - Canadian Association of Professional Regulatory Affairs

• CARS - CDRH Ad hoc Reporting System

• CARS - Compliance Achievement Reporting System

• CARTS - CFSAN Automated Research Tracking System

• CAS - Chemical Abstracts Service

• CAs - competent authorities

• CASE - computer aided software engineering

• CASPER - Center Automated System Process Exchange and Reporting (CFSAN)

• CAST - Calf Antibiotic and Sulfonamide Test

• CAST - Council for Agricultural Science

• CAT - computerized axial tomography

• CATCH - Child and Adolescent Trial for Cardiovascular Health (NIH)

• CBC - complete blood count

• CBCTN - Community-based Clinical Trials Network (AmFAR)

• CBE - changes being effected

• CBER - Center for Biologics Evaluation and Research (FDA)

• CBG - capillary blood gas

• CBIAC - Chemical and Biological Defense Information Analysis Center (DoD)

• CBO - Congressional Budget Office (U.S.)

• CBP - Customs and Border Protection (U.S. Department of Homeland Security)

• CBRA - California Biomedical Research Association

• CBRG - Cancer Biomarkers Research Group (NCI)

• CBRN - Chemical Biological Radiological Nuclear

• CBSC - cord blood stem cells

• CBT - computer-based training

• CC - chief complaint

• CC - Clinical Center (NIH)

• CC - Commissioned Corps

• CC - conference call

• CC - Coordinating Committee

• CC/RVDF - Codex Committee on Residues of Veterinary Drugs in Foods

• CCA - Clinger-Cohen Act (formerly the Information Technology Management Reform Act)

• CCB - Change Control Board

• CCB (CFSAN) - Color Certification Branch (CFSAN)

• CCBC - Council of Community Blood Centers

• CCC - Chinese ceramicware factory code (ORA AofC code)

• CCC - Commodity Credit Corporation (FSA)

• CCC - Compliance Coordinating Committee (CDER)

• CCEHRP - Committee to Coordinate Environmental Health and Related Programs (PHS)

• CCFAC - Codex Committee on Food Additives and Contaminants

• CCFICS - Codex Committee on Food Import and Export Certification and Inspection Systems

• CCFL - Codex Committee on Food Labeling

• CCHIT - Certification Commission for Healthcare Information Technology

• CCI - corrected count increment

• CCOHTA - Canadian Coordinating Office for Health Technology Assessment

• CCOP - Community Clinical Oncology Program (NCI)

• CCP - critical control point

• CCPR - Codex Committee on Pesticide Residues

• CCR - CDER request for collaborative review

• CCR - Center for Cancer Research (NCI)

• CCRA - Clinical Contract Research Association (UK)

• CCRC - certified clinical research coordinator

• CCST (CFSAN) - Clinical Chemistry Support Team (CFSAN)

• CCU - cardiac care unit

• CCU - clean catch urine

• CCVDF - Codex Committee on Veterinary Drugs in Foods

• CD-ROM - compact disc read-only memory

• CDA - clinical document architecture

• CDASH - Clinical Data Acquisition Standards Harmonization

• CDC - Centers for Disease Control and Prevention (DHHS)

• CDDI - Collaboration for Drug Development Improvement

• CDDTB (CBER) - Career Development and Directed Training Branch (CBER)

• CDER - Center for Drug Evaluation and Research (FDA)

• CDIS - Component Distribution Information System

• CDISC - Clinical Data Interchange Standards Consortium

• CDM - clinical data management

• CDP - Candidate Development Program (SES)

• CDP - career development plan

• CDR - central document room

• CDR - clinical drug request

• CDRH - Center for Devices and Radiological Health (FDA)

• CDRS (CFSAN) - Case Development and Recall Staff (CFSAN)

• CDSA - Controlled Drugs and Substances Act (Canada)

• CDTL - Cross Discipline Team Leader

• CDUS - Clinical Data Update System (NCI)

• CE - continuing education

• CE Mark - CE (Conformite Europeene or European Conformity) marking

• CE-FO (ORA) - Central Regional Field Office

• CEA - Council of Economic Advisers

• CEARS - CBER Error and Accident Reporting System

• CEB (CDER) - Clinical Evaluation Branch (CBER)

• CEB (CFSAN) - Compliance and Enforcement Branch (CFSAN)

• CEDR - Comprehensive Epidemiologic Data Resource (U.S. Department of Energy)

• CEF - chick embryo fibroblast

• CEFIC - European Chemical Industry Council

• CEMB (CDRH) - Cardiac Electrophysiology and Monitoring Devices Branch (CDRH)

• CEN - Comite Europeen de Normalisation (European Committee for Standardization)

• CENELEC - Comite Europeen de Normalisation Electrotechnique (European Committee for Electrotechnical Standardization)

• CEO - Chief Executive Officer

• CEPPO - Chemical Emergency Preparedness and Prevention Office (EPA)

• CEQ - Council on Environmental Quality

• CERCLIS - Comprehensive Environmental Response, Compensation and Liability Information System (EPA)

• CERG - CBER Emergency Relocation Group

• CERSI - Centers of Excellence in Regulatory Science and Innovation

• CERT - Community Emergency Response Team

• CERTS - Centers for Education and Research on Therapeutics (DHHS)

• CES (CFSAN) - Consumer Education Staff (CFSAN)

• CET (CFSAN) - Clinical Evaluation Team (CFSAN)

• CEU - continuing education units

• CF - cystic fibrosis

• cfa - Catfish Farmers of America

• CFAST - Coalition For Accelerating Standards and Therapies

• CFC - chlorofluorohydrocarbons

• CFC - Combined Federal Campaign

• CFD - computational fluid dynamic

• CFDA - Catalog of Federal Domestic Assistance

• CFG - Center for Functional Genomics (NCTR)

• CFG - Certificate for Foreign Government

• CFIA - Canadian Food Inspection Agency

• CFN - central file number (ORA)

• CFO - chief financial officer

• CFO (OC) - Chief Financial Officer (OC)

• CFOC - Chief Financial Officers Council

• CFR - Code of Federal Regulations

• CFR - Code of Federal Regulations section (ORA AofC code)

• CFSAN - Center for Food Safety and Applied Nutrition (FDA)

• CFU - colony forming unit

• CGCS - computer-generated cover sheet

• CGI - common gateway interface

• CGL - chronic granulocytic leukemia

• cGMP - current good manufacturing practice

• CGMPR - Current Good Manufacturing Practices Regulations

• CGS (ORA) - Contract and Grants Staff (ORA)

• CGTP - current good tissue practice

• CH - clinical hold

• CHAMPVA - Civilian Health and Medical Program of the Department of Veterans Affairs

• CHAT (CFSAN) - Chemical Hazards Assessment Team (CFSAN)

• CHCB (CFSAN) - Chemical Contaminants Branch (CFSAN)

• CHD - coronary heart disease

• CHDC - Contractor Hosted Data Center

• CHF - congestive heart failure

• CHI - Consolidated Health Informatics Initiative

• CHID - Combined Health Information Database (NIH)

• CHISSA - Center for High Integrity Software System Assurance

• ChLIA - chemi-luminescent immunoassay

• CHMP - Committee for Medicinal Products for Human Use

• CHO - carbohydrate

• CHPA - Consumer Healthcare Products Association

• CHSB (CFSAN) - Chemical Hazards Science Branch (CFSAN)

• CI - clinical investigator

• CI - confidence interval

• CI - confidential informant

• CI - criminal investigator

• CI/KR - Critical infrastructure and key resources

• CIA - Central Intelligence Agency (U.S.)

• CIA - corporate integrity agreement

• CIAC - Computer Incident Advisory Capability (U.S. Department of Energy)

• CIAO - Critical Infrastructure Assurance Office

• CIB - clinical investigator's brochure

• CIB (CFSAN) - Compliance Information Branch (CFSAN)

• CIN - Color Index number (ORA AofC code)

• CINAHL - Cumulative Index to Nursing and Allied Health Literature

• CIO - chief information officer

• CIOMS - Council for International Organizations of Medical Sciences (WHO)

• CIP - clean in place

• CIP - Critical Infrastructure Protection

• CIPP - Critical Infrastructure Protection Program

• CIR - cosmetic ingredient review

• CIRMS - Council on Ionizing Radiation Measurements and Standards

• CIRS - Center Information Retrieval System (CDRH)

• CIS - Cancer Information Service (NCI)

• CIS - catastrophic incident supplement (FEMA)

• CISET - Committee on International Science, Engineering and Technology

• CIT - Center for Information Technology (NIH)

• CITES - Convention on International Trade in Endangered Species of Wild Fauna and Flora

• CJD - Creutzfeldt Jakob disease

• CLA - conference lodging allowance

• CLIA - Clinical Laboratory Improvement Amendments of 1988

• CLIIL - Clinical Investigator Inspection List

• CLSI - Clinical and Laboratory Standards Institute

• CLT - central limit theorem

• CM - case management

• CM - chemistry and manufacturing (Canada)

• CM - committee meeting

• CM - configuration management

• CMA - Chemical Manufacturers Association

• Cmax - maximum plasma concentration

• CMC - chemistry, manufacturing, and control

• CMCCC - Chemistry and Manufacturing Controls Coordinating Committee (CDER)

• CME - continuing medical education

• CMGB (CDER) - Cae Management and Guidance Branch (CDER)

• CMHS - Center for Mental Health Services (SAMHSA)

• CMI - Consumer Medical Information

• CMO - contract management organization

• CMP - civil money penalty

• CMP/ HMO - comprehensive medical plan/health maintenance organization

• CMS - Centers for Medicare and Medicaid Services (DHHS) (formerly HCFA)

• CMV - cytomegalovirus

• CN - cranial nerves

• CND (CDRH) - Cardiovascular/Neurological Devices Branch (CDRH)

• CNPP - Center for Nutrition Policy and Promotion (USDA)

• CNS - central nervous system

• CNS - Congress of Neurological Surgeons

• CO - commissioned officer

• CO - compliance officer

• CO - contract officer

• COA - certificate of analysis

• COA - Commissioned Officers Association (PHS)

• COB - close of business

• COB (OC) - Contract Operations Branch (OC)

• COBRA - Consolidated Omnibus Budget Reconciliation Act

• COBTA - Council on Biologics and Therapeutic Agents (of AVMA)

• COCB (CFSAN) - Communication and Coordination Branch (CFSAN)

• CODB (CDRH) - Cardiovascular and Ophthalmic Devices Branch (CDRH)

• CODEX - Codex Alimentarius

• CoE - Center of Excellence

• COE - certificate of exportability

• COFEPRIS - Comisión Federal para la Protección contra Riesgos Sanitarios (Federal Commission for the Protection Against Sanitary Risks) (Mexico)

• COI - conflict of interest

• COLA - cost of living allowance

• COLD - chronic obstructive lung disease

• COMAH - Control of Major Accident Hazards Regulations 1999

• COMIS - Center-wide Oracle Management Information System

• COMSTAT - Compliance Status Information System

• CONOPS - concept of operations

• CONSER - Cooperative Online Serials

• CONUS - continental United States

• COOL - country-of-origin labeling

• COOP - continuity of operations plan

• COP - clean out of place

• COP - Coastal Ocean Program (NOAA)

• COP - continuation of pay

• COPD - chronic obstructive pulmonary disease

• COPR - Council of Public Representatives (NIH OD)

• COPTRG - Community Oncology and Prevention Trials Research Group (NCI)

• COR - Contracting Officer’s Representative

• CORE - Coordinated Outbreak Response and Evaluation

• CORE - EASE central repository module

• CoS - certificate of suitability

• COS - cosmetic registration number (ORA AofC code)

• COS (CFSAN) - Cosmetics Staff (CFSAN)

• COSTART - Coding Symbols for Thesaurus of Adverse Reaction Terms

• COTA - Career Opportunities Training Agreement (HHS)

• COTB (CBER) - Communication Technology Branch (CBER)

• COTS - commercial off-the-shelf software

• COTT - Committee of Ten Thousand

• CP - cerebral palsy

• CP - chest pain

• CP - citizen petition

• CP - compliance program

• CPAC - Central Pharmaceutical Affairs Council (Japan)

• CPAP - continuous positive airway pressure

• CPB (CFSAN) - Compliance Programs Branch (CFSAN)

• CPC - Compliance Policy Council

• CPCSEA - Committee for the Purpose of Control and Supervision on Experiments on Animals (India)

• CPD - Center for Professional Development

• CPDA - citrate phosphate dextrose adenine

• CPDF - Central Personnel Data File (OPM)

• CPE - continuing professional education

• CPFP - Cancer Prevention Fellowship Program (NCI)

• CPG - Compliance Policy Guide

• CPGM - Compliance Program Guidance Manual

• CPI - consumer price index

• CPIC - Capital Planning and Investment Control

• CPID - Certified Product Information Document (Canada)

• CPK - creatinine phosphokinase

• CPMP - Committee for Proprietary Medicinal Products (EMEA)

• CPMS - Chief, Project Management Staff (CDER)

• CPP - certificate of pharmaceutical product

• CPP - critical process parameter

• CPR - cardiopulmonary resuscitation

• CPS - Compendium of Pharmaceuticals and Specialties (Canada)

• CPSA - Consumer Product Safety Act

• CPSC - Consumer Product Safety Commission

• CPT - Current Procedural Terminology (AMA)

• CQA - Critical Quality Attribute

• CR - collection report

• CR - complete response (letter)

• CRA - clinical research associate

• CRADA - cooperative research and development agreement

• CRB - Change Review Board

• CRB (CBER) - Clinical Review Branch (CBER)

• CRC - Civil Rights Center (U.S. Department of Labor)

• CRC - clinical research coordinator

• CRCL - creatinine clearance

• CRCPD - Conference of Radiation Control Program Directors

• CRF - case report form

• CRF - chronic renal failure

• CRIS - Clinical Research Information System (NIH)

• CRISP - Computer Retrieval of Information on Scientific Projects (database) (NIH)

• CRIX - Clinical Research Information Exchange (FDA and NCI)

• CRM - corporate records management

• CRMT (OC) - Cosmetics Toxicology Branch (CFSAN)

• CRMTS - CBER Regulatory Meetings Management Tracking System

• CRO - clinical research organization

• CRO - contract research organization

• CRP - C-reactive protein

• CRR - consult review request

• CRS - Congressional Research Service

• CRS - Contamination Response System

• CRT - case report tabulations

• CRTP - Clinical Research Training Program

• CRU - Center Recall Unit

• CRWG - Hurricane Katrina Comprehensive Review Working Group

• CS - civil service

• CS - clinically significant

• CS (CVM) - Communications Staff (CVM)

• CS (OC) - Communications Staff (OC)

• CSA - clinical study agreement

• CSA - Controlled Substances Act

• CSAP - Center for Substance Abuse Prevention (SAMHSA)

• CSAT - Center for Substance Abuse Treatment (SAMHSA)

• CSB - Chemical Safety and Hazard Investigation Board

• CSB (OC) - Customer Support Branch (OC)

• CSB (ORA) - Customer Support Branch (ORA)

• CSC - Computational Science Center

• CSDD - Center for the Study of Drug Development (Tufts University)

• CSF - cerebrospinal fluid

• CSG - Counterterrorism Security Group

• CSI - consumer safety inspector

• CSM - Committee on Safety of Medicines (UK)

• CSO - consumer safety officer

• CSPDB (CDRH) - Circulatory Support and Prosthetic Devices Branch (CDRH)

• CSPI - Center for Science in the Public Interest

• CSR - Center for Scientific Review (NIH)

• CSR - clinical study report

• CSR - customer service records

• CSR - customer service representative (EASE)

• CSREES - Cooperative State Research, Education and Extension Services (USDA)

• CSS (CDER) - Controlled Substance Staff (CDER)

• CST - consumer safety technician

• CST (CFSAN) - Consumer Studies Team (CFSAN)

• CSTE - Council of State and Territorial Epidemiologists

• CSV - comma separated value (file format)

• CSV - computer system validation

• CT - clinical trial

• CT - computed tomography

• CTA - clinical trial agreement

• CTA - clinical trial application

• CTAP - Career Transition Assistance Plan

• CTB (CBER) - Cell Therapies Branch (CBER)

• CTC - chlortetracycline

• CTC - clinical trial certificate

• CTC - common toxicity criteria

• CTD - common technical document

• CTDB 1 (CDRH) - Chemistry and Toxicology Devices Branch 1 (CDRH)

• CTDB 2 (CDRH) - Chemistry and Toxicology Devices Branch 2 (CDRH)

• CTEB (CFSAN) - Cosmetics Technology Branch (CFSAN)

• CTEP - Cancer Therapy Evaluation Program

• CTFA - Cosmetic, Toiletry and Fragrance Association

• CTIA - Cellular Telecommunications and Internet Association

• CTM - clinical trials materials

• CTO - clinical trial outline

• CTOB (CFSAN) - Cosmetics Toxicology Branch (CFSAN)

• CTP - Center for Tobacco Products

• CTRS - CDRH Time Reporting System

• CTS - Center Tracking System

• CTS - Correspondence Tracking System

• CTS - counseling and testing site

• CTTB (CBER) - Cellular and Tissue Therapy Branch (CBER)

• CTTI - Clinical Trials Transformation Initiative

• CTX - clinical trials exemption (UK)

• CU - Consumers Union

• CUE - confidential unit exclusion

• CUF - Commissione Unica del Farmaco (Italy)

• CUVP - Committee for Veterinary Medicinal Products (EMEA)

• CV - cardiovascular

• CV - curriculum vitae

• CVA - cerebrovascular accident

• CVA - costovertebral angle

• CVD - cardiovascular disease

• CVM - Center for Veterinary Medicine (FDA)

• CVMP - Committee on Veterinary Medical Products (EMEA)

• CVP - central venous pressure

• CWD - Chronic Wasting Disease

• CXR - chest x-ray

• CY - calendar year

• D & C - dilation and curettage

• D0AF (CDRH) - Division of Planning, Analysis and Finance (CDRH)

• DA (OC) - Division of Accounting (OC)

• DAA - designated approving authority

• DAAP (CDER) - Division of Anesthesia and Analgesia Products (CDER)

• DAARP (CDER) - Division of Anesthesia, Analgesia, and Rheumatology Products (CDER)

• DAC (CFSAN) - Division of of Analytical Chemistry (CFSAN)

• DADS - Developers and Distributors System

• DADS (CDER) - Division of Applications Development and Services (CDER)

• DAE (OC) - Division of Applied Engineering (OC)

• DAEA II - Division of Adverse Event Analysis 2 (CDER)

• DAF (CVM) - Division of Animal Feeds (CVM)

• DAFM (CVM) - Division of Animal and Food Microbiology (CVM)

• DAGID (CDRH) - Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (CDRH)

• DAIDS - Division of AIDS (NIAID)

• DailyMed - NLM-based database of information on marketed drugs including FDA-approved labels.

• DAIOP (CDER) - Division of Anti-infective and Ophthalmology Products (CDER)

• DAIP (CDER) - Division of Anti-Viral Products (CDER)

• DAL - defect action level

• DAPR (CDER) - Division of Applied Pharmacology Research (CDER)

• DAR (CVM) - Division of Animal Research (CVM)

• DARPA - Defense Advanced Research Projects Agency (DoD)

• DARRTS - Document Archiving, Reporting and Regulatory Tracking System

• DART - Developmental and Reproductive Toxicology

• DAS (CFSAN) - Division of Administrative Services Management (CFSAN)

• DAS (NCTR) - Division of Administrative Services (NCTR)

• DAT - diet as tolerated

• DATS - Document Accountability and Tracking System (CBER)

• DAVP (CDER) - Division of Anti-viral Products (CDER)

• DAVR (CVM) - Division of Applied Veterinary Research (CVM)

• DAWN - drug abuse warning network

• DB - double-blind

• DB (CBER) - Division of Biostatistics (CBER)

• DB (CDRH) - Division of Biology (CDRH)

• DB I (CDER) - Division of Biometrics I (CDER)

• DB II (CDER) - Division of Biometrics II (CDER)

• DB III (CDER) - Division of Biometrics III (CDER)

• DB IV (CDER) - Division of Biometrics IV (CDER)

• DB V (CDER) - Division of Biometrics V (CDER)

• DB VI (CDER) - Division of Biometrics VI (CDER)

• dba - doing business as

• DBA (CBER) - Division of Blood Applications (CBER)

• DBC (CFSAN) - Division of Bioanalytical Chemistry (CFSAN)

• DBCP (CBER) - Division of Blood Collection and Processing (CBER)

• DBE (CDER) - Division of Bioequivalence (CDER)

• DBEC (OC) - Division of Budget Execution and Control (OC)

• DBEPA (CBER) - Division of Blood Establishment and Product Applications (CBER)

• DBGLPC (CDER) - Division of Bioequivalence and Good Laboratory Practices Compliance (CDER)

• DBGNR (CFSAN) - Division of Biotechnology and GRAS Notice Review (CFSAN)

• DBGNR (CFSAN) - Division of Biotechnology and GRAS Notice Review (CFSAN)

• DBM (CDRH) - Division of Bioresearch Monitoring (CDRH)

• DBMS - database management system

• DBMSS (CDER) - Division of Business Management Services and Solutions (CDER)

• DBOP (CDER) - Division of Biologic Oncology Products (CDER)

• DBPAP (CBER) - Division of Bacterial, Parasitic and Allergenic Products (CBER)

• DBRA (NCTR) - Division of Biometry and Risk Assessment (NCTR)

• DBS (CDRH) - Division of Biostatistics (CDRH)

• DBT (NCTR) - Division of Biochemical Toxicology (NCTR)

• DC - discharge

• DC - discontinue

• DC (CVM) - Division of Compliance (CVM)

• DC (NCTR) - Division of Chemistry (NCTR)

• DC I (CDER) - Division of Chemistry I (CDER)

• DC II (CDER) - Division of Chemistry II (CDER)

• DC III (CDER) - Division of Chemistry III (CDER)

• DCB (CFSAN) - Domestic Compliance Branch (CFSAN)

• DCC - Document Control Center

• DCC (CBER) - Document Control Center (CBER)

• DCC (CFSAN) - Division of Cosmetics and Compliance (CFSAN)

• DCC (OC) - Division of Customer Care (OC)

• DCCA (CBER) - Division of Communication and Consumer Affairs (CBER)

• DCCT (CFSAN) - Division of Color Certification and Technology (CFSAN)

• DCD (CDRH) - Division of Cardiovascular Devices (CDRH)

• DCEPT (CBER) - Division of Clinical Evaluation and Pharmacology/Toxicology (CBER)

• DCF - data clarification request form

• DCGM (OC) - Division of Contracts and Grants Management (OC)

• DCGT (CBER) - Division of Cell and Gene Therapies (CBER)

• DCIA - Debt Collection Act of 1996

• DCIQA (ORA) - Division of Compliance Information and Quality Assurance (ORA)

• DCIS - Design Control Inspection Strategy

• DCLD (CDRH) - Division of Clinical Laboratory Devices (CDRH)

• DCM (CBER) - Division of Case Management (CBER)

• DCM (CDRH) - Division of Communications Media (CDRH)

• DCMO (ORA) - Division of Compliance Management and Operations (ORA)

• DCMS (CDRH) - Division of Chemistry and Material Science (CDRH)

• DCP (CFSAN) - Division of Cooperative Programs (CFSAN)

• DCP (NCTR) - Division of Contracts and Procurement (NCTR)

• DCP (ORA) - Division of Compliance Policy (ORA)

• DCP 1 (CDER) - Division of Clinical Pharmacology 1 (CDER)

• DCP 2 (CDER) - Division of Clinical Pharmacology 2 (CDER)

• DCP 3 (CDER) - Division of Clinical Pharmacology 3 (CDER)

• DCP 4 (CDER) - Division of Clinical Pharmacology 4 (CDER)

• DCP 5 (CDER) - Division of Clinical Pharmacology 5 (CDER)

• DCPA (CBER) - Division of Congressional and Public Affairs (CBER)

• DCPS - Defense Civilian Pay System

• DCRER (CFSAN) - Division of Chemistry Research and Environmental Review (CFSAN)

• DCRMS (CDER) - Division of Compliance Risk Management and Surveillance (CDER)

• DCRP (CDER) - Division of Cardiovascular and Renal Products (CDER)

• DCSC (OC) - Division of Construction and Service Contracts (OC)

• DCT (CDER) - Division of Counter-terrorism (CDER)

• DCTD (CDRH) - Division of Chemistry and Toxicology Devices (CDRH)

• DCU - document control unit

• DD - Department of Drugs (Swedish Regulatory Agency)

• DD - division director

• DD (CVM) - district director

• DDA - Division of Drug Analysis (CDER)

• DDB (CDRH) - Dental Devices Branch (CDRH)

• DDB (CDRH) - Diagnostic Devices Branch (CDRH)

• DDDP (CDER) - Division of Dermatology and Dental Products (CDER)

• DDDQ (CDER) - Division of Domestic Drug Quality (CDER)

• DDE - drug data entry

• DDE - dynamic data exchange

• DDES (CFSAN) - Division of Dairy and Egg Safety (CFSAN)

• DDI (CDER) - Division of Drug Information (CDER)

• DDM (NCTR) - Deputy Director for Management (NCTR)

• DDM (OC) - Division of Dockets Management (OC)

• DDMAC (CDER) - Division of Drug Marketing, Advertising and Communication (CDER)

• DDMS (CDER) - Division of Database Management and Services (CDER)

• DDMSS (CDER) - Division of Data Management Services and Solutions (CDER)

• DDOM (CBER) - Division of Disclosure and Oversight Management (CBER)

• DDOP (CDER) - Division of Drug Oncology Products (CDER)

• DDQCSS (CDER) - Division of Drug Quality and Compliance Services and Solution (CDER)

• DDR - Division Document Room

• DDR - Donor Deferral Registry

• DDRE (CDER) - Division of Drug Risk Evaluation (CDER)

• DDS - Deputy Director for Safety (CDER)

• DDSPC (CFSAN) - Division of Dietary Supplement Programs and Compliance (CFSAN)

• DDT - Drug Development Tools

• DE (CBER) - Division of Epidemiology (CBER)

• DE (CFSAN) - Division of Enforcement (CFSAN)

• DEA - Drug Enforcement Administration (U.S. Department of Justice)

• DEB (CFAN) - Dairy and Egg Branch (CFSAN)

• DEC (CFSAN) - Division of Education and Communication (CFSAN)

• DEEM - dietary exposure evaluation model

• DEHP - Di(2-ethylhexyl)phthalate

• DEIO (ORA) - Division of Emergency and Investigational Operations (ORA)

• DEMO (CDRH) - Division of Ethics and Management Operations (CDRH)

• DEN - drug experience network

• DEOD (CDRH) - Dental, Ear, Nose, Throat and Ophthalmic Devices Branch (CDRH)

• DEP - Data Evaluation Project

• DEPI (CBER) - Division of Ethics and Program Integrity (CBER)

• DEPI (CDER) - Division of Epidemiology (CDER)

• DER - drug experience report

• DES - diethylstilbestrol

• DES - Drug eluting stent

• DES (CVM) - Division of Epidemiology and Surveillance (CVM)

• DES (OC) - Division of Engineering Services (OC)

• DESE (CDRH) - Division of Electrical and Software Engineering (CDRH)

• DESI - Drug Efficacy Study Implementation

• DETTD (CBER) - Division of Emerging and Transfusion Transmitted Diseases (CBER)

• DEV - device registration number (ORA AofC code)

• DFARS - Drug Firm Annual Registration Status

• DFCN (CFSAN) - Division of Food Contact Notifications (CFSAN)

• DFEM (NCTR) - Division of Facilities Engineering and Maintenance (NCTR)

• DFFI - Division of Foreign Field Investigations (ORA)

• DFLSC (CFSAN) - Division of Food Labeling, Standards, and Compliance (CFSAN)

• DFM (NCTR) - Division of Financial Management (NCTR)

• DFO - designated federal official

• DFO (OC) - Division of Field Operations (OC)

• DFOI (OC) - Division of Freedom of Information (OC)

• DFPG (CFSAN) - Division of Field Programs and Guidance (CFSAN)

• DFPP (CFSAN) - Division of Food Processing and Packaging (Chicago, Illinois) (CFSAN)

• DFPST (CFSAN) - Division of Food Processing Science and Technology (CFSAN)

• DFRM - Drug Facility Registration Module (FURLS)

• DFS - Division File System

• DFS (ORA) - Division of Field Science (ORA)

• DFSR - Division of Federal-State Relations (Office of Regulatory Affairs)

• DGCPC (CDER) - Division of Good Clinical Practice Compliance (CDER)

• DGFPS - Direccion General de Farmacia y Productos Sanitarios (Directorate General of Pharmacy and Sanitary Products) (Spain)

• DGIEP (CDER) - Division of Gastroenterology and Inborn Errors Products (CDER)

• DGMPA (CDER) - Division of Good Manufacturing Practice Assessment (CDER)

• DGP (CDER) - Division of Gastroenterology Products (CDER)

• DGRND (CDRH) - Division of General, Restorative and Neurological Devices (CDRH)

• DGRT (NCTR) - Division of Genetic and Reproductive Toxicology (NCTR)

• DGSS (CFSAN) - Division of General Scientific Support (CFSAN)

• DH (CBER) - Division of Hematology (CBER)

• DHC - dioxin health certificate (ORA AofC code)

• DHCP - Dear Healthcare Professional (type of letter)

• DHCP - Dynamic Host Configuration Protocol

• DHF - design history file

• DHFS (CVM) - Division of Human Food Safety (CVM)

• DHHS - Department of Health and Human Services (U.S.)

• DHR - device history record

• DHRD (ORA) - Division of Human Resources Development (ORA)

• DHS - Department of Homeland Security (U.S.)

• DHSS - Department of Health and Social Security (U.K.)

• DHT (CBER) - Division of Human Tissues (CBER)

• DI - deionized water

• DI - diabetes insipidus

• DIA - Defense Intelligence Agency (U.S.)

• DIA - Drug Information Association

• DIAM (CDRH) - Division of Imaging and Applied Mathematics (CDRH)

• DIB - Directory, Investigations Branch

• DIBD - Development International Birth Date

• DIC - disseminated intravascular coagulation

• DICOM - Digital Imaging and Communications in Medicine

• DID (CBER) - Division of Information Development (CBER)

• DIDP (CBER) - Division of Information Disclosure Policy (CDER)

• DIDQ (CDER) - Division of International Drug Quality (CDER)

• DIHD (CDRH) - Division of Immunology and Hematology Devices (CDRH)

• DILI - drug-induced liver injury

• DIMS (CFSAN) - Data Information Management Staff (CFSAN)

• DIMS (OC) - Division of Infrastructure Management and Services (OC)

• DIN - drug identification number (Canada)

• DIO (CBER) - Division of Information Operations (CBER)

• DIO (OC) - Division of Infrastructure Operations (OC)

• DIOP (ORA) - Division of Import Operations and Policy (ORA)

• DIOR (CDER) - Division of Import Operations and Recalls (CDER)

• DIRM (CFSAN) - Division of Information Resources Management (CFSAN)

• DIS (CBER) - Division of Inspections and Surveillance (CBER)

• DIS (CDER) - Division of Information Services (CDER)

• DIT (CDRH) - Division of Information Technology (CDER)

• DIT (NCTR) - Division of Information Technology (NCTR)

• DIVBT (CFSAN) - Division of In Vitro and Biochemical Toxicology (CFSAN)

• DJD - degenerative joint disease

• DKA - diabetic ketoacidosis

• dL - deciliter

• DLI - donor lymphocyte infusion

• DLPS (CDER) - Division of Labeling and Program Support (CDER)

• DLR - drug listing rule

• DLS - Document Logging System (CBER)

• DLS - drug listing number (ORA AofC code)

• DM - diabetes mellitus

• DM (CFSAN) - Division of Mathematics (CFSAN)

• DM (CFSAN) - Division of Microbiology (CFSAN)

• DM (NCTR) - Division of Microbiology (NCTR)

• DMA - Danish Medicines Agency

• DMA (CDER) - Division of Monoclonal Antibodies (CDER)

• DMARDS - disease-modifying antirheumatic drug

• DMAT - Disaster Medical Assistance Team

• DMAT (CBER) - Division of Manufacturers Assistance and Training (CBER)

• DMB - Dockets Management Branch

• DMB (CDER) - Division of Management and Budget (CDER)

• DMB (CFSAN) - Division of Molecular Biology (CFSAN)

• DMC - Data Monitoring Committee

• DMD (CDRH) - Division of Microbiology Devices (CDRH)

• DME - durable medical equipment

• DME (NCTR) - Division of Molecular Epidemiology (NCTR)

• DMEP (CDER) - Division of Metabolism and Endocrinology Products (CDER)

• DMEPA (CDER) - Division of Medical Error Prevention and Analysis

• DMETS (CDER) - Division of Medical Errors and Technical Support (CDER)

• DMF - drug master file

• DMIHP (CDER) - Division of Medical Imaging and Hematology Products (CDER)

• DMIP - Division of Medical Imaging Products (CDER)

• DMIRDP (CDER) - Division of Medical Imaging and Radiopharmaceutical Drug Products (CDER)

• DMO (CFSAN) - Division of Management Operations (CFSAN)

• DMO (ORA) - Division of Management Operations (ORA)

• DMORT - Disaster Mortuary Operational Response Team

• DMPQ (CBER) - Division of Manufacturing and Product Quality (CBER)

• DMPQ (CDER) - Division of Manufacturing and Product Quality (CDER)

• DMQRP (CDRH) - Division of Mammography Quality and Radiation Programs (CDRH)

• DMR - device master record

• DMS (CDER) - Division of Management Services (CDER)

• DMS (CFSAN) - Division of Microbiological Studies (CFSAN)

• DMS (OC) - Division of Management Systems (OC)

• DMSO - dimethylsulfoxide

• DMST (CFSAN) - Division of Market Studies (CFSAN)

• DMT - DARRTS Management Team

• DMT (CVM) - Division of Manufacturing Technologies (CVM)

• DNA - deoxyribonucleic acid

• DNCE (CDER) - Division of Nonprescripton Clinical Evaluation (CDER)

• DNDLC (CDER) - Division of New Drugs and Labeling Compliance (CDER)

• DNP (CDER) - Division of Neurology Products (CDER)

• DNP (CFSAN) - Division of Natural Products (CFSAN)

• DNPDHF (CDER) - Division of Nonprescription Drugs and Health Fraud (CDER) (formerly OTC Drugs and Health Fraud Branch - OTCDHFB)

• DNPL (CFSAN) - Division of Nutrition Programs and Labeling (CFSAN)

• DNR - do not resuscitate

• DNRD (CDER) - Division of Nonprescription Regulation Development (CDER)

• DNS - domain name server

• DNT (NCTR) - Division of Neurotoxicology (NCTR)

• DO - disbursing officer

• DO - District Office (FDA)

• DOA - dead on arrival

• DOA - drugs of abuse

• DOC - Department of Commerce (U.S.)

• DOC - documentary sample

• DoD - Department of Defense (U.S.)

• DODP (CDER) - Division of Oncologic Drug Products (CDER)

• DOE - Department of Energy (U.S.)

• DOE - design of experiment

• DOE - dyspnea on exertion

• DOE A (CDRH) - Division of Enforcement A (CDRH)

• DOE B (CDRH) - Division of Enforcement B (CDRH)

• DOEd - Department of Education (U.S.)

• DOED (CDRH) - Division of Ophthalmic, Ear, Nose and Throat Devices (CDRH)

• DOI - Department of the Interior (U.S.)

• DOJ - Department of Justice (U.S.)

• DOL - Department of Labor (U.S.)

• DONED - Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices (CDRH)

• DOS - Department of State (U.S.)

• DOT - Department of Transportation (U.S.)

• DOT (CFSAN) - Division of Toxicology (CFSAN)

• DP - drug product

• DP (CDRH) - Division of Physics (CDRH)

• DP (NCTR) - Division of Planning (NCTR)

• DPA (CDER) - Division of Pharmaceutical Analysis (CDER)

• DPA (CDER) - Division of Public Affairs (CDER)

• DPA I (CDER) - Division of Pre-marketing Assessment I (CDER)

• DPA II (CDER) - Division of Pre-marketing Assessment II (CDER)

• DPAMS (CDER) - Division of Pre-marketing Assessment III and Manufacturing Science (CDER)

• DPAP (CDER) - Division of Pulmonary and Allergy Products (CDER)

• DPARP (CDER) - Division of Pulmonary, Allergy, and Rheumatology Products (CDER)

• DPC-PTR Act - Drug Price Competition and Patent Trade Restoration Act of 1984

• DPCDO (CDER) - Division of Policy, Collaboration, and Data Operations (CDER)

• DPD (CDER) - Division of Prescription Drugs (CDER) (formerly Prescription Drugs Branch - PDB)

• DPD (CVM) - Division of Production Drugs (CVM)

• DPD (OC) - Division of Portfolio Development (OC)

• DPDD (CDER) - Division of Pediatric Drug Development (CDER)

• DPDFS (CFSAN) - Division of Plant and Dairy Food Safety (CFSAN)

• DPE (CDER) - Division of Post-marketing Development (CDER)

• DPEB (CBER) - Division of Planning, Evaluation and Budget (CBER)

• DPEM (ORA) - Division of Planning, Evaluation and Management (ORA)

• DPEPOPD (CFSAN) - Division of Programs and Enforcement Policy (OPDFB) (CFSAN)

• DPEPOS (CFSAN) - Division of Programs and Enforcement Policy (OS) (CFSAN)

• DPFRM (CFSAN) - Division of Planning and Financial Resources Management (CFSAN)

• DPHB (CFSAN) - Division of Public Health and Biostatistics (CFSAN)

• DPI - dry powder inhaler

• DPIC (CFSAN) - Division of Pesticides and Industrial Chemicals (CFSAN)

• DPL - Drug Product Licensing (Canada)

• DPMU - Disaster Portable Morgue Unit (PHS)

• DPP (CDER) - Division of Psychiatry Products (CDER)

• DPPS (CFSAN) - Division of Plant Product Safety (CFSAN)

• DPQ (CBER) - Division of Product Quality (CBER)

• DPQR (CDER) - Division of Product Quality Research (CDER)

• DPR (CFSAN) - Division of Petition Review (CFSAN)

• DPRF - Drug Product Reference File

• DPS (CBER) - Division of Program Services (CBER)

• DPS (CDRH) - Division of Post-marketing Surveillance (CDRH)

• DPS (CFSAN) - Division of Program Services (CFSAN)

• DPT - diphtheria, pertussis, and tetanus

• DPV I (CDER) - Division of Pharmacovigilance I (CDER)

• DPV II (CDER) - Division of Pharmacovigilance II (CDER)

• DQ - design quality

• DQRS - Drug Quality Reporting System (CDER)

• DR - delayed release medication

• DR - discipline review letter

• DRA (CFSAN) - Division of Risk Assessment (CFSAN)

• DRARD (CDRH) - Division of Reproductive, Abdominal and Radiological Devices (CDRH)

• DRAT (CFSAN) - Division of Research and Applied Technology (CFSAN)

• DRB (CBER) - Devices Review Branch (CBER)

• DRC - Disaster Recovery Center

• DRC (CVM) - Division of Residue Chemistry (CVM)

• DRF - dose range findings (study)

• DRFDD (ORA) - Deputy Regional Food and Drug Director (ORA)

• DRG - diagnosis related group

• DRG - Disaster Response Group

• DRGUD - Division of Reproductive, Gastrorenal and Urology Devices (CDRH)

• DRI - daily reference intake

• DRISK (CDER) - Divison of Risk Management (CDER)

• DRLM - Device Registration and Listing Module (FURLS)

• DRLS - Drug Registration and Listing System

• DRM (CDER) - Division of Records Management (CDER)

• DRM (OC) - Division of Resource Management (OC)

• DRMO (CDRH) - Division of Risk Management Operations (CDRH)

• DRMP (CDER) - Division of Review Management and Policy (CDER)

• DRP (CBER) - Division of Regulations and Policy (CBER)

• DRP I (CDER) - Division of Regulatory Policy I (CDER)

• DRP II (CDER) - Division of Regulatory Policy II (CDER)

• DRPM - dispute resolution project manager

• DRR (NCTR) - Deputy Director for Research (NCTR)

• DRRDSSS (CDER) - Division of Regulatory Review and Drug Safety Services and Solutions (CDER)

• DRUP (CDER) - Division of Reproductive and Urologic Products (CDER)

• DRV - daily reference value

• DS - drug substance

• DS (CVM) - Division of Surveillance (CVM)

• DSAC (CBER) - Division of Scientific Advisors and Consultants (CBER)

• DSATOS (CFSAN) - Division of Science and Applied Technology (OS) (CFSAN)

• DSB - Drug Safety Oversight Board

• DSC - Data Standards Council (FDA)

• DSC - Drug Safety Communication

• DSC (CDER) - Division of Safety Compliance (CDER)

• DSCI (CDER) - Division of Supply Chain Integrity (CDER)

• DSCI (OC) - Division of Systems, Compliance and IMPAC (OC)

• DSDB (CDRH) - Diagnostic and Surgical Devices Branch (CDRH)

• DSFM (CDRH) - Division of Solid and Fluid Mechanics (CDRH)

• DSHEA - Dietary Supplement and Health Education Act of 1994

• DSI (CDER) - Division of Scientific Investigation (CDER)

• DSM - Data Standards Manual (CDER)

• DSMB - Data Safety Monitoring Board

• DSMICA (CDRH) - Division of Small Manufacturers, International and Consumer Assistance (CDRH)

• DSORD - Division of Surgical, Orthopedic, And Restorative Devices (CDRH)

• DSP - Desktop Standardization Project

• DSP (OC) - Division of Strategic Projects (OC)

• DSPTP (CDER) - Division of Special Pathogen and Transplant Products (CDER)

• DSRCS (CDER) - Division of Surveillance, Research and Communication Support (CDER)

• DSRIT (CFSAN) - Dietary Supplement Regulations Implementation Team (CFSAN)

• DSS - Decision Support System

• DSS (CDRH) - Division of Surveillance Systems (CDRH)

• DSS (CFSAN) - Division of Seafood Safety (CFSAN)

• DSS (CFSAN) - Division of Social Sciences (CFSAN)

• DSST (CFSAN) - Division of Seafood Science and Technology (CFSAN)

• DSUR - Development Safety Update Report

• DTaP - diphtheria, tetanus, and pertussis vaccine

• DTBIMP (CDER) - Division of Therapeutic Biological Internal Medicine Products (CDER)

• DTBOP (CDER) - Division of Therapeutic Biological Oncology Products (CDER)

• DTC - direct-to-consumer

• DTD - Device Tracking Database

• DTD - document type definition (for electronic interchange)

• DTD (CDER) - Division of Training and Development (CDER)

• DTDFA (CVM) - Division of Therapeutic Drugs for Food Animals (CVM)

• DTDNFA (CVM) - Division of Therapeutic Drugs for Non-food Animals (CVM)

• DTNPS (CFSAN) - Division of Toxicology and Nutrition Product Studies (CFSAN)

• DTOP (CDER) - Division of Transplant and Ophthalmology Products (CDER)

• DTP - direct-to-patient

• DTP (CDER) - Division of Therapeutic Proteins (CDER)

• DTR - deep tendon reflexes

• DTR - detention request

• DTS - Distribution Tracking System (CBER)

• DUNS - Data Universal Numbering System

• DUPSA (CDRH) - Division of Device User Programs and System Analysis (CDRH)

• DUR - drug utilization review

• DUSM - Deputy United States Marshal (U.S. Department of Justice)

• DV - daily value

• DVA (CFSAN) - Division of Virulence Assessment (CFSAN)

• DVD - digital video disc

• DVM - Doctor of Veterinary Medicine

• DVP (CBER) - Division of Viral Products (CBER)

• DVPS (CVM) - Division of Veterinary Product Safety

• DVRPA (CBER) - Division of Vaccines and Related Product Applications (CBER)

• DVS (CBER) - Division of Veterinary Services (CBER)

• DVS (NCTR) - Division of Veterinary Services (NCTR)

• DVT - deep venous thrombosis

• DW - data warehouse

• DWPE - Detention Without Physical Examination

• DX - diagnosis

• DXA - dual-energy X-ray absorptiometry test

• e-CRF - electronic case report form

• E2B - Efficacy Topics' Data Elements for Transmission of Adverse Drug Reactions Reports (ICH)

• EA - environmental assistance

• EAA - essential amino acids

• EAB - Ethics Advisory Board

• EAB (CFSAN) - Exposure Assessment Branch (CFSAN)

• EAC - Expert Advisory Committee (Canada)

• EAFUS - Everything Added to Food in the United States

• EAR - Export Administration Regulations (U.S. Department of Commerce)

• EAS - Emergency Alert System

• EAS (CDER) - Enterprise Architecture Staff (CDER)

• EASE - Enterprise Administrative Support Environment

• EB (CDRH) - Epidemiology Branch (CDRH)

• EB (NCTR) - Engineering Branch (NCTR)

• EBAA - Eye Bank Association of America

• eBPDR - electronic biological product deviation reporting

• EBS - Emergency Broadcast System

• EC - European Community

• ECBS - Expert Committee on Biological Standardization (WHO)

• eCDT - Electronic Common Technical Document (ICH M2 Multi-disciplinary Group 2 EWG Expert Working Group)

• ECE - Economic Commission for Europe

• ECG - electrocardiogram

• ECL - electrochemiluminescence

• ECMO - extra-corporeal membrane oxygenation

• ECQ - Executive Code Qualifications

• eCRF - electronic case report form

• ECRI - Emergency Care Research Institute (no longer uses name initials only)

• ECRS (CFSAN) - Emergency Coordination and Response Staff (CFSAN)

• ECS (OC) - Economics Staff (OC)

• ECT - electroconvulsive therapy

• ECT (CFSAN) - Economics Team (CFSAN)

• eCTD - electronic common technical document

• ECU - European currency unit

• ED - effective dose

• EDI - electronic data exchange

• EDIFACT - Electronic Data interchange for Administration, Commerce, and Transportation

• EDIPI - electronic data interchange personal identifier

• EDKB - Endocrine Disrupter Knowledge Base

• EDMF - European drug master file

• EDMS - Electronic Document Management System

• EDQM - European Directorate for the Quality of Medicines

• EDR - electronic document room

• EDR - enhanced design review

• EDRG - Early Detection Research Group

• eDRLS - Electronic Drug Registration and Listing Systems

• EEA - European Economic Area

• EEC - European Economic Community

• EEG - electroencephalogram

• EEO - Equal Employment Opportunity

• EEO (CFSAN) - Equal Employment Opportunity Office (CFSAN)

• EEO (NCTR) - Equal Employment Opportunity Staff (NCTR)

• EEOC - Equal Employment Opportunity Commission

• EEP - External Expertise and Partnerships

• EEPS - Electronic Entry Processing System

• EER - establishment evaluation request

• EES - establishment evaluation system

• EFD - engineering flow diagram

• EFGCP - European Forum on Good Clinical Practice

• EFOIA - Electronic Freedom of Information Act

• EFPIA - European Federation of Pharmaceutical Industries and Associations

• EFT - electronic funds transfer

• EFTA - European Free Trade Association

• EGA - European Generics Medicines Association

• EH & S - environmental health and safety

• EHPAS (NCTR) - Environmental Health and Program Assurance Staff (NCTR)

• EHPC - Environmental Health Policy Committee (formerly CCEHRP) (currently inactive)

• EHR - electronic health record

• EHRP - Enterprise Human Resources and Payroll System

• EI - establishent inspection

• EI - Establishment Inventory (ORA)

• EIA - environmental impact assessment

• EIA - enzyme immunoassay

• EID - electronic identification device

• EIF - Expected Investment Fund

• EIM - Enterprise Information Management

• eIND - electronic investigational new drug application

• EINECS - European Inventory of Existing Commercial Chemical Substances

• EIP - Emerging Infections Program (CDC)

• EIR - Entrepreneurs in Residence Program (CDRH)

• EIR - establishment inspection report

• EIS - environmental impact statement

• EIS - Epidemic Intelligence Service

• EIS (OC) - Ethics and Integrity Staff (OC)

• EKG - electrocardiogram

• ELA - establishment license application

• ELDU - extra-label drug use

• eLEXNET - Electronic Laboratory Exchange Network

• ELINS - European List of Notified Chemical Substances

• ELIPS - Electronic Labeling Information Processing System (FDA)

• ELISA - Enzyme-linked immunosorbent assay

• eLIST - electronic listing system

• ELMS - Enterprise System Life Cycle Management Support

• ELPS - establishment licensing and product surveillance

• ELS - Establishment License Supplement

• EMAC - Emergency Management Assistance Compact

• EMBS - Engineering in Medicine and Biology Society (IEEE)

• EMC - electromagnetic compatibility

• EMEA - European Medicines Agency (formerly European Medicines Evaluation Agency)

• EMI - electromagnetic interference

• EML - Environmental Measurement Laboratory

• EMOPS (OC) - Office of Emergency Operations (OC)

• EMS - Emergency Medical Services

• EMV - eye-motor-verbal (Glasgow coma scale)

• ENG (OC) - Engineering Team (OC)

• ENL - erythema nodosum leprosum

• ENT - ear, nose and throat

• ENTB (CDRH) - Ear, Nose, and Throat Devices Branch (CDRH)

• EO - executive order

• EOC - Emergency Operations Center (FDA)

• EOD - enter on duty

• eOFP - electronic Official Personnel File

• EOM - extraocular muscles

• EOP - Emergency Operations Plan

• EOP1 - end-of phase 1

• EOP2 - end-of-phase 2

• EORTC - European Organisation for Research and Treatment of Cancer

• EOS - end of study

• EOS (CDER) - Executive Operations Staff (CDER)

• EOS (ORA) - Executive Operations Staff (ORA)

• EP - European Pharmacopoeia

• EPA - Environmental Protection Agency (U.S.)

• EPAR - European Public Assessment Reports (EMEA)

• EPC - Evidence-based Practice Center

• EPD (CDRH) - Electronic Product Devices Branch (CDRH)

• EPFA - European Plasma Fractionation Association

• EPI - essential prescribing information

• EPIA - Egg Products Inspection Act

• EPIA - Egg Products Inspection Act

• EPL - effective patent life

• EPLC - Enterprise Performance Life Cycle

• EPMS - Employee Performance Management System

• EPO - European Patent Office

• EPRG - European Pharmacovigilance Research Group

• EPRS - Establishment Product Registration System

• EPT (CFSAN) - Epidemiology Team (CFSAN)

• ER - extended release medication

• ER/ES - electronic records/electronic signatures

• ERB - Ethics Review Board

• ERB (CFSAN) - Elemental Research Branch (CFSAN)

• ERC - Engineering Research Center (NSF)

• ERCP - endoscopic retrograde cholangio-pancreatography

• EREA - Export Reform and Enhancement Act of 1996

• ERIC - Employee Resource Information Center

• ERISA - Employee Retirement Income Security Act of 1974

• ERP - Emergency Response Plan

• ERP - enterprise resource planning

• ERR - entry review recommended (ORA AofC code)

• ERS - Economic Research Service (USDA)

• ERS - electronic regulatory submission

• ERS - Emergency Relocation Site

• ERSB (CFSAN) - Emergency Response and Surveillance Branch (CFSAN)

• ERSR - Electronic Regulatory Submissions and Review

• ERT - Emergency Response Team

• ES - effect size

• eSAF - Electronic State Access to FACTS

• ESB (ORA) - Enterprise Systems Branch (ORA)

• ESC - electronic submission coodinator

• ESD - electrostatic discharge

• ESF - Emergency Support Function

• ESG - Electronic Submissions Gateway

• ESIG - electronic signature

• ESM - Electronic Secure Messaging

• ESR - erythrocyte sedimentation rate

• ESRA - European Society of Regulatory Affairs

• ESS (CBER) - Executive Secretariat Team (CBER)

• ESS (NCTR) - Executive Secretariat Staff (NCTR)

• ESTRI - Electronic Standards for the Transfer of Regulatory Information

• esub - electronic submission

• ET - endotracheal

• ET - excepted trust

• ET (CFSAN) - Education Team (CFSAN)

• ETA - EASE time and attendance module

• ETASU - Elements to Assure Safe Use

• EtOH - ethanol

• ETS - environmental tobacco smoke

• eTS - eTravel services vendors

• ETT - endotracheal tube

• ETT - exercise tolerance test

• EU - endotoxin unit

• EU - European Union

• EUA - emergency use authorization

• EUA - examination under anesthesia

• EUCOMED - European Confederation of Medical Devices Associations

• EUP - experimental use permit

• EV-D68 - Enterovirus D68

• EVA - entry validation application

• EVS (OC) - Evaluation Staff (OC)

• EWG - expert working group

• FA - filing action

• FAA - Federal Aviation Administration (U.S. Department of Transportation)

• FAAN - Food Allergy and Anaphylaxis Network

• FACA - Federal Advisory Committee Act 1972

• FACS (CFSAN) - Food Advisory Committee Staff (CFSAN)

• FACT - Food Animal Concerns Trust

• FACT - Functional Assessment of Cancer Therapy

• FACTS - Field Accomplishments and Compliance Tracking System

• FACTS - Frequency of Agents Communicable by Transfusion Study

• FACTS@FDA - system for electronically communicating approved drug labeling and for disseminating prescribing information

• FAEMS - Foods Adverse Event Monitoring System

• FAERS - FDA Adverse Event Reporting System

• FAHCT - Foundation for Accreditation of Hematopoietic Cell Therapy

• FAI - further action indicated

• FAIR - Federal Activities Inventory Reform Act of 1998

• FALCPA - Food Allergen Labeling and Consumer Protection Act

• FAM - foreign affairs manual

• FAME - Formula for Achieving Managerial Excellence

• FAN - Food Allergy Network

• FAO - Food and Agriculture Organization of the United Nations

• FAP - food additive petition

• FAP - food additive petition approval number (ORA AofC code)

• FAPMC - Food Animal Production Medicine Consortium

• FAQ - frequently asked questions

• FAR - Federal Acquisition Regulations

• FAR - Field Alert Report

• FARAD - Food Animal Residue Avoidance Databank

• FARM - Food Additives Regulatory Management System (CFSAN)

• Farmindu stria - Association of Italian Pharmaceutical Manufacturers

• FASA - Federal Acquisition Streamlining Act of 1994

• FASAB - Federal Accounting Standards Advisory Board

• FASEB - Federation of American Societies for Experimental Biology

• FASS - Federation of Animal Science Societies

• FASTAR - FDA Advanced Submission Tracking and Review

• FAT - factory acceptance test

• FATA - federal agency travel administrator

• FATA - Federal Anti-Tampering Act

• FAX - facsimile

• FBI - Federal Bureau of Investigation (U.S. Department of Justice)

• FBS - fasting blood sugar

• FCC - Federal Communications Commission (U.S.)

• FCC - Forensic Chemistry Center

• FCC - French cheese facility certification number (ORA AofC code)

• FCCSET - Federal Coordinating Council for Science, Engineering and Technology

• FCE - food canning establishment number (ORA aofC code)

• FCIC - Federal Consumer Information Center

• FCLAA - Federal Cigarette Labeling and Advertising Act

• FCN - food contact substance notification

• FCO - Federal Coordinating Officer

• FCRDC - Frederick Cancer Research and Development Center

• FCS - Food Contact Substance

• FD&C ACT - Federal Food, Drug, and Cosmetic Act of 1938

• FD-1932 - FDA form for veterinary adverse drug reaction, lack of effectiveness, product defect report--mandatory

• FD-1932a - FDA form for veterinary adverse drug reaction, lack of effectiveness, product defect report--voluntary

• FD-2301 - FDA form for transmittal of periodic reports and promotional material for new animal drugs

• FD-356V - FDA form for new animal drug appication

• FD-483 - FDA form used as a written notice of deficiencies found in inspections

• FDA - Food and Drug Administration

• FDA GLOBE - Gay, Lesbian, Bisexual, Transgender Employees of the Federal Government within FDA

• FDA-ARGOS - FDA dAtabase for Regulatory Grade micrObial Sequences

• FDA-SRS - Spontaneous Reporting System of the Food and Drug Administration

• FDAAA - Food and Drug Administration Amendments Act

• FDAMA - Food and Drug Administration Modernization Act of 1997

• FDARA - FDA Revitalization Act

• FDAS - Defense Finance and Accounting Services

• FDASIA - Food and Drug Administration Safety and Innovation Act

• FDASS (OC) - FDA Safety Staff (OC)

• FDC - Food, Drug, & Cosmetic

• FDCA - Federal Food, Drug, and Cosmetic Act of 1938

• FDERA - Food and Drug Export Reform and Enhancement Act of 1996

• FDF - Finished Dosage Form

• FDLI - Food and Drug Law Institute

• FDOT (CFSAN) - Food Defense Oversight Team (CFSAN)

• FEB - Federal Executive Board

• FECA - Federal Employees' Compensation Act

• FedGLOBE - Gay, Lesbian, Bisexual, Transgender Employees of the Federal Government

• FEDRIP - Federal Research in Progress Database

• FedRooms - Federal Premier Lodging Program

• FEEA - Federal Employee Assistance and Education Fund

• FEGLI - Federal Employees Group Life Insurance

• FEHB - Federal Employees Health Benefits Program

• FEHBP - Federal Employees Health Benefits Program

• FEI - FDA Establishment Identifier (ORA)

• FEMA - Federal Emergency Management Agency

• FERC - Federal Energy Regulatory Commission

• FERN - Food Emergency Response Network

• FERS - Federal Employees Retirement System

• FES (OC) - Financial Enterprise Solutions (OC)

• FF - Fogarty Fellow

• FFD & C - Federal Food, Drug and Cosmetic Act of 1938

• FFDCA - Federal Food, Drug, and Cosmetic Act of 1938

• FFLA - Family Friendly Leave Act

• FFP - fresh frozen plasma

• FFRM - Food Facility Registration Module (FURLS)

• FFS - fee for service

• FGF - fibroblast growth factor

• FGIS - Comisión Federal para la Protección contra Riesgos Sanitarios (Federal Commission for the Protection Against Sanitary Risks) (Mexico)

• FHA - Federal Health Architecture

• FHSA - Federal Hazardous Substances Act (Consumer Product Safety Commission)

• FIC - John E. Fogarty International Center (NIH)

• FICA - Federal Insurance Contributions Act

• FIFO - first in first out

• FIFR - first-in-first reviewed

• FIFRA - Federal Insecticide, Fungicide, and Rodenticide Act

• FIH - first-in-human clinical trials

• FIREBIRD - Federal Investigator Registry for Bioinformatics Research Data

• FIRSt - FDA Information Retrieval System

• FIS - Field Information System

• FISMA - Federal Information Security Management Act

• FIT - FDA Internet Improvement Team

• FIT - FSMA Implementation Team (FSMA - Food Safety Modernization Act)

• FLC - Federal Laboratory Consortium

• FLETC - Federal Law Enforcement Training Center

• FLQ - fluoroquinolone

• FLSA - Fair Labor Standards Act

• FLSS (CFSAN) - Food Labeling and Standards Staff (CFSAN)

• FLTCIP - Federal Long Term Care Insurance Program

• FM - filing meeting

• FM - final monograph

• FMB (CDRH) - Financial Management Branch (CDRH)

• FMCS - Federal Mediation and Conciliation Service

• FMD - field management directives

• FMD - foot and mouth disease

• FMEA - failure modes and effect analysis

• FMECA - failure modes effects and criticality analysis

• FMFIA - Federal Management Financial Integrity Act of 1982

• FMI - Food Marketing Institute

• FMIA - Federal Meat Inspection Act

• FML - Firms Master List (ORA)

• FMLA - Family Medical Leave Act of 1993

• FMRI - functional magnetic resonance imaging

• FMS - Financial Management Service (U.S. Department of the Treasury)

• FNCS - Food, Nutrition, and Consumer Services

• FNH - febrile non-hemolytic reaction

• FNS - Food and Nutrition Service

• FOB - federal office building

• FOI - freedom of information

• FOIA - Freedom of Information Act

• FOIB (CDRH) - Freedom of Information Branch (CDRH)

• FONSI - finding of no significant impact

• FOP - financial operating plan

• FORCG - Foodborne Outbreak Response Coordinating Group

• FOT - FSMA Operations Team (FSMA - Food Safety Modernization Act

• FOUO - for official use only

• FPA - Food Products Association

• FPB (CDRH) - Field Programs Branch (CDREH)

• FPB (CFSAN) - Field Programs Branch (CFSAN)

• FPB (CFSAN) - Food Processing Branch (Chicago, Illinois) (CFSAN)

• FPBR (CFSAN) - Food Packaging Branch (Chicago, Illinois) (CFSAN)

• FPEC - Food Program Executive Committee

• FPET (CFSAN) - Food Processing Evaluation Team (CFSAN)

• FPIF - Finnish Pharmaceutical Industry Association

• FPL - final printed label

• FPLA - Fair Packaging and Labeling Act (1967)

• FPLP - Federal Premier Lodging Program

• FPS - Federal Protective Service (Department of Homeland Security)

• FPVST (OC) - Facilities Planning and Voice Services Team (OC)

• FQ - fluoroquinolone

• FQPA - Food Quality Protection Act of 1996

• FR - Federal Register

• Fr.P. - Pharmacopee Francaise (French Pharmacopoeia)

• FRAC - FDA Research Animal Council

• FRC - Federal Records Center (Suitland)

• FRC - functional residual capacity

• FRDTS - Federal Register Document Tracking System

• FRP - Federal Response Plan (FEMA)

• FS - feasibility study

• FS - federal standard (U.S.)

• FSA - Farm Service Agency (USDA)

• FSANZ - Food Standards Australia New Zealand

• FSH - follicle-stimulating hormone

• FSI - Food Safety Initiative (CFSAN)

• FSIS - Food Safety and Inspection Service (USDA)

• FSMA - Food Safety Modernization Act

• FSPS (ORA) - Federal-State Program Staff (ORA)

• FSTA - federal supervisory travel approver

• FT (OC) - Financial Team (OC)

• FTA - fault tree analysis

• FTB (CFSAN) - Food Technology Branch (CFSAN)

• FTC - Federal Trade Commission (U.S.)

• FTCA - Federal Trade Commission Act

• FTE - full-time equivalent

• FTIM - first time in man

• FTP - file transfer protocol

• FTR - Federal Travel Regulations

• FTS - Federal Telecommunications System

• FTT - failure to thrive

• FU - Farmacopea Ufficiale (Italian Pharmacopoeia)

• FUO - fever of unknown origin

• FURLS - FDA Uniform Registration & Listing System

• FVC - forced vital capacity

• FWAP - Flexible Workplace Arrangements Program

• FWFPS - Field Work Force Planning System

• FWP - Federal Women's Program

• Fx - fracture

• FY - fiscal year

• FYI - for your information

• G-MED (LNE) - Medical Device Assessment Group (Laboratoire National de Metrologie et d'Essias)

• GAAP - Greater Access to Affordable Pharmaceuticals Act of 2003

• GADIS - Global Alliance of Drug Information Specialists

• GADPTRA - Generlc Animal Drug and Patent Term Restoration Act

• GAMP - good automated manufacturing practice

• GAO - General Accounting Office

• GAO - Government Accountability Office (U.S.)

• GAPS - good agricultural practices

• GARR - Grants Application Review Request

• GAT - genome amplification testing

• GATT - General Agreement of Tariffs and Trade

• GBCA - gadolinium-based contrast agent

• GBL - government bill of lading

• GC - gas chromatography

• GC - general counsel (FDA)

• GC - gonorrhea

• GCBS - Global Collaboration for Blood Safety (WHO)

• GCC - Government Coordinating Council of the Food and Agriculture Sector

• GCLP - good clinical laboratory practice

• GCP - good clinical practice

• GCPB I (CDER) - Good Clinical Practice Branch I (CDER)

• GCPB II (CDER) - Good Clinical Practice Branch II (CDER)

• GCPP (OC) - Good Clinical Practice Program (OC)

• GCRC - General Clinical Research Centers

• GCSL (CFSAN) - Gulf Coast Seafood Laboratory (Dauphin Island, Alabama) (CFSAN)

• GDEA - Generic Drug Enforcement Act of 1992

• GDS - global distribution system

• GDUF - Generic Drug User Fees

• GDUFA - Generic Drug User Fee Amendments

• GEBAT - government excess baggage authorization ticket

• GeMCRIS - Genetic Modification Clinical Research Information System (NIH)

• GEO - genetically engineered organism

• GEP - good engineering practice

• GFSP - Global Food Safety Partnership

• GG - goal group

• GGP - good guidance practice

• GHC - Group Health Cooperative

• GHDB (CDRH) - General Hospital Devices Branch (CDRH)

• GHS - Globally Harmonised System of Classification and Labelling of Chemicals (UN)

• GHTF - Global Harmonization Task Force

• GI - gastrointestinal

• GI-ARS - Gastrointestinal Acute Radiation Syndrome

• GIF - graphics interchange format

• GILS - Government Information Locator Service

• GIPSA - Grain Inspection, Packers & Stockyards Administration (USDA)

• GIS - geographical information system

• GLP - good laboratory practice

• GLPBB (CDER) - Good Laboratory Practices and Bioequivalence Investigations Branch (CDER)

• GM - genetically modified

• GMA - Grocery Manufacturers Association

• GMDN - Global Medical Device Nomenclature

• GME - Graduate Medical Education

• GMID - Global Market Information Database

• GMO - genetically modified organism

• GMO - Grants Management Officer

• GMP - good manufacturing practice

• GnRH - gonadotropin-releasing hormone

• GOCO - government-owned contractor-operated

• GOCRG - Gastrointestinal and Other Cancer Research Group

• GOTS - government off-the-shelf

• GOVCC - government travel charge card

• GOVTRIP - government travel website operated by Northrop Grumman

• GPEA - Government Paperwork Elimination Act

• GPhA - Generic Pharmaceutical Association

• GPO - Government Printing Office (U.S.)

• GPO - group purchasing organization

• GPP - good programming practices

• GPRA - Government Performance Results Act of 1993

• GPRD - General Practice Research Database

• GRAS - generally recognized as safe

• GRAS/E - generally recognized as safe and effective

• GRASE - generally recognized as safe and effective

• GRC - Gerontology Research Center

• GRDB (CDRH) - Gastroenterology and Renal Devices Branch (CDRH)

• GRMP - Good Review Management Principles and Practices

• GRNs - Generally Recognized as Safe Notifications

• GRP - good review practice

• GRS - general records schedule

• GRUVSS - Global Regulatory Utilization of Vaccine Safety Surveillance

• GS - General Schedule

• GSA - General Services Administration (U.S.)

• GSDB (CDRH) - General Surgery Devices Branch (CDRH)

• GSFA - general standard for food additives

• GSP - Good Statistics Practice

• gt - drops

• GTB (CBER) - Gene Therapies Branch (CBER)

• GTIB (CBER) - Gene Transfer and Immunogenicity Branch (CBER)

• GTIN - Global Trade Item Number

• GTIS - Gene Therapy Information System

• GTL (NCTR) - Genetic Toxicology Laboratory (NCTR)

• gtt - drops

• GTT - glucose tolerance test

• GU - genitourinary

• GUI - graphical user interface

• GWQAP - Government Wide Quality Assurance Program

• GxP - good "x" practices

• GXT - graded exercise tolerance (Stress test)

• H/H - hemoglobin/hematocrit

• H/H - Henderson-Hasselbach equation

• HA - headache

• HAA - hepatitis-associated antigen

• HAACP - Hazard Analysis and Critical Control Point

• HAART - Highly Active Antiretroviral Therapy – the name commonly given to combinations of anti-HIV drugs

• HAB (CFSAN) - Hazard Assessment Branch (CFSAN)

• HAC - Health Administration Center (VA)

• HACCP - hazard analysis critical control point

• HAD - Hospital Anxiety and Depression scale

• HAI - Health Action International

• HAM/TSP - HTLV-I-associated myelopathy / tropical spastic paraparesis

• HARTS - Hoechst Adverse Reaction Terminology System

• HAV - hepatitis A virus

• HAZMAT - hazardous material

• HAZOP - hazard and operability

• HBOC - hemoblogin-based oxygen carrier

• HBOT - Hyperbaric Oxygen Therapy

• HBP - high blood pressure

• HBV - hepatitis B virus

• HCDB (CDRH) - Hematology and Cytology Devices Branch (CDRH)

• HCFA - Health Care Financing Administration (now CMS)

• HCG - human chorionic gonadotropin

• HCI - human-computer interaction

• HCO - health care organization

• HCP - healthcare provider

• HCT - hematocrit

• HCT/P - human cellular and tissue-based products

• HCTERS - Human Cell and Tissue Establishment Registration System

• HCTRS - Human Cell and Tissue Establishment Registration System

• HCTZ - hydrochlorothiazide

• HCV - hepatitis C virus

• HDC - High dose chemotherapy

• HDE - humanitarian use exemptions (CDRH)

• HDL - high density lipoprotein

• HDMA - Healthcare Distribution Management Association

• HDP - hydroxymethylene diphosphonate

• HDPE - high density polyethylene

• HEENT - head, eyes, ears, nose, throat

• HEO - Hispanic Employee Organization

• HEPA - high efficiency particulate air (filter)

• hERG - human ether-a-go-go gene

• HF - high frequency

• HF - mail code for FDA Office of the Commissioner

• HFA - Hemophilia Federation of America

• HFA - hydrofluoroalkane

• HFD - mail code for CDER

• HFEB (CDRH) - Human Factors Engineering Branch (CDRH)

• HFES - Human Factors and Ergonomics Society

• HFM - mail code for CBER

• HFS - mail code for CFSAN

• HFT - mail code for NCTR

• HFV - mail code for CVM

• HFZ - mail code for CDRH

• Hgb - hemoglobin

• HGH - human growth hormone

• HHE - health hazard evaluation

• HHI - Herth Hope Index

• HHMI - Howard Hughes Medical Institute

• HHS - Health and Human Services (U.S. Department of)

• HHS ASPA - Health and Human Services (U.S. Department of), Office of the Assistant Secretary for Public Affairs

• HHS SERT - Health and Human Services Secretary's Emergency Response Team

• HIBCC - Health Industry Business Communication Council

• HIM - Health Information Management

• HIMA - Health Industry Manufacturers Association

• HIMSS - Healthcare Information Management Systems Society

• HIPAA - Health Insurance Portability and Accountability Act of 1996

• HIRS - Health Information Resources Service

• HISB - Health Informatics Standards Board

• HISPC - Health Information Security and Privacy Collaboration

• HIT - Health Information Technology

• HITSP - Health Information Technology Standards Panel

• HIV - human immunodeficiency virus

• HL7 - Health Level 7

• HLA - Human Leukocyte Antigen

• HLBT - heat labile bacterial toxins

• HLGT - high level group term

• HLT - high level term

• HLT - Hurricane Liaison Team (FEMA)

• HMO - health maintenance organization

• HNK cells - human neonatal kidney cells

• HPB - Health Protection Board (Canada)

• HPB - Hematological Products Branch (CBER) (defunct)

• HPC - hematopoietic progenitor cells

• HPC - human progenitor cells

• HPFB - Health Products and Food Branch (Canada's FDA)

• HPHC - harmful and potentially harmful constituents

• HPK - human pharmacokinetic

• HPLC - high performance liquid chromatography

• HPO - high performance organization

• HPUS - Homeopathic Pharmacopeia of the United States

• HPV - human papillomavirus

• HR - heart rate

• HR - human resources

• HRG - health research group

• HRRC - Human Research Review Committee

• HRSA - Health Resources and Services Administration (DHHS)

• HS - at bedtime

• HS - handling statement

• HS - high structure

• HSA - Health Services Administration

• HSBT - heat stable bacterial toxins

• HSC - Homeland Security Council

• HSIN - Homeland Security Information Network

• HSOC - Homeland Security Operations Center

• HSPD - Homeland Security Presidential Directive

• HSS - Hemophilia Surveillance System (CDC)

• HSUS - Humane Society of the United States

• HSV - herpes simplex virus

• HTLV - human T-lymphotropic virus

• HTLV-III - human lymphotropic virus, type III (AIDS agent, HIV)

• HTM - health technical memorandum

• HTML - hypertext markup language

• HTN - hypertension

• HTRB (CBER) - Human Tissue and Reproduction Branch (CBER)

• HTTP - hypertext transfer protocol

• HUD - Department of Housing and Urban Development (U.S.)

• HUD - humanitarian use device (CDER)

• HVAC - heating, ventilating, and air conditioning

• Hx - history

• I & D - incision and drainage

• I & O - intake and output

• IA - Import Administration (U.S. Department of Commerce)

• IAB (CDRH) - Information and Analysis Branch (CDRH)

• IAB (ORA) - Infrastructure Applications Branch (ORA)

• IACUC - Institutional Animal Care and Use Committee

• IAG - Interagency Agreement

• IAL - informal action levels

• IAMFES - International Association of Milk, Food and Environmental Sanitarians

• IARC - International Agency for Research on Cancer (WHO)

• IAS (CFSAN) - Industry Activities Staff (CFSAN)

• IAS (CFSAN) - International Affairs Staff (CFSAN)

• IAS (OC) - International Agreements Staff (OC)

• IAST (CFSAN) - International Activities Staff (CFSAN)

• IATA - International Air Transport Association

• IAVG - Interagency Vaccine Group

• IAW - in accordance with

• IB - Investigator's Brochure

• IB (CFSAN) - Immunobiology Branch (CFSAN)

• IB (ORA) - International Branch (ORA)

• IBB (CFSAN) - Instrumentation and Biophysics Branch (CFSAN)

• IBD - International Birth Date

• IBE - individual bioequivalence

• IBP - Indian black pepper certificate (ORA AofC code)

• IBR (CFSAN) - Import Branch (CFSAN)

• IBS - irritable bowel syndrome

• IC - informed consent

• ICA - intelligent console architecture

• ICA - inter-Center agreement

• ICAM - International Cooperative Agreements Manual

• ICAO - International Civil Aviation Organization

• ICB (CDRH) - Inspection and Compliance Branch (CDRH)

• ICB (CFSAN) - Implementation and Compliance Branch (CFSAN)

• ICCBBA - International Council for Commonality in Blood Banking Automation, Inc.

• ICCVAM - Interagency Coordinating Committee on Validation of Alternative Methods

• ICD - informed consent document

• ICD-9-CM - International Classification of Diseases, Ninth Revision, Clinical Modification

• ICDB (CDRH) - Infection Control Devices Branch (CDRH)

• ICDB (CDRH) - Interventional Cardiology Devices Branch (CDRH)

• ICDRA - International Conference of Drug Regulatory Authorities

• ICE - Immigration and Customs Enforcement (Department of Homeland Security)

• ICF - Informed Consent Form

• ICH - International Conference on Harmonisation (of Technical Requirements for Registration of Pharmaceuticals for Human Use)

• ICIB (CDRH) - Intraocular and Corneal Implants Branch (CDRH)

• ICL - idiopathic CD4+ T-lymphocytopenia

• ICLAS - International Council for Laboratory Animal Science

• ICMJE - International Committee of Medical Journal Editors

• ICPEMC - International Commission for Protection Against Environmental Mutagens and Carcinogens

• ICRP - International Commission on Radiological Protection

• ICRU - International Commission on Radiation Units and Measurements

• ICS - Incident Command System

• ICSR - Individual Case Safety Reports

• ICTAP - Interagency Career Transition Assistance Plan

• ICU - intensive care unit

• ID - Identification

• IDC - Information and Data Committee

• IDDM - insulin dependent diabetes mellitus

• IDE - investigational device exemption (CDRH)

• IDE - investigational device exemption number (ORA AofC code)

• IDE (CDRH) - Investigational Device Exemptions Sections (CDRH)

• IDF - Immune Deficiency Foundation

• IDF - International Dairy Federation

• IDIQ - indefinite-delivery, indefinite-quantity contracts

• IDL - international date line

• IDM - Informational Disclosure Manual

• IDP - individual development plan

• IDR - idiosyncratic drug reaction

• IEC - Independent Ethics Committee (DHHS)

• IEE - intervention effect estimate

• IEEE - Institute of Electrical and Electronics Engineers

• IFA - indirect fluorescent antibody

• IFA - investigational food additive (file)

• IFAD - International Food Additives Database (CFSAN)

• IFE - import for export (ORA AofC code)

• IFIC - International Food Information Council

• IFIP - International Federation for Information Processing

• IFMFS (CFSAN) - Infant Formula and Medical Foods Staff (CFSAN)

• IFPMA - International Federation of Pharmaceutical Manufacturers Associations

• IFSAC - Interagency Food Safety Analytics Collaboration

• IFT - Institute of Food Technologists

• IFU - instructions for use

• IFWG - Interagency Food Working Group

• IG - immunoglobulin

• IG - inspector general

• IgA - immunoglobin A

• IgD - immunoglobin D

• IgE - immunoglobin E

• IGF - insulin-like growth factor

• IgG - immunoglobin G

• IGIV - immune globulin intravenous

• IgM - immunoglobin M

• IHS - Indian Health Service (DHHS)

• IIC - inspector-in-charge

• iiFAR - incurably ill for Animal Research

• IIG - Inactive Ingredient Guide

• IIMB (CDRH) - IT Infrastructure Management Branch (CDRH)

• IIMG - Interagency Incident Management Group

• IIS - internet information officer

• ILAR - Institute for Laboratory Animal Research

• IM - Intramuscular

• IMB - Irish Medicines Board

• IMB (CDER) - Interface Management Branch (CDER)

• IMB (CDRH) - Information Management Branch (CDRH)

• IMC - Information Management Consultants, Inc.

• IMCC - Information Management Coordinating Committee (CBER)

• IMDA - Irish Medical Device Association

• IMDB (CDRH) - Immunology and Molecular Diagnostics Devices Branch (CDRH)

• IMDG - International Maritime Dangerous Goods Code

• IMDRF - International Medical Device Regulators Forum

• IMLS - Institute of Museum and Library Services

• IMO - International Maritime Organisation

• IMP - investigational medicinal product

• IMPAC - Information for Management, Planning, Analysis and Coordination

• IMPAC - International Merchant Purchase Authorization Card

• IMPD - Investigational Medicinal Product Dossier (EU)

• IMS - Information Management System

• IMS - Interstate Milk Shippers

• IMS (CDRH) - Issues Management Staff (CDRH)

• IMT - Incident Management Team

• IMT - International Medical Terminology

• IMTS - Industry Meeting Tracking System

• INA - investigational new animal drug number (ORA AofC code)

• INAD - investigational new animal drug

• INADA - investigational new animal drug application

• IND - investigational new drug

• IND - investigational new drug application

• IND - investigational new drug number (ORA AofC code)

• INDA - investigational new drug application

• INDC - Investigational New Drug Committee

• INFARME D - Instituto Nactional da Farmaciae e do Medicamento (Portugal)

• INN - International Approved Names for Pharmacopoeial Substances

• INN - international nonproprietary name

• INNS - International Neural Network Society

• INS - incident of national significance

• INV sample - investigational sample

• IO - Immediate Office

• IOB - International Operations Branch (ORA)

• IOM - Institute of Medicine of the National Academies

• IOM - Investigation Operations Manual

• IOTF - Interagency Oncology Task Force (FDA and NCI)

• IP - information panel

• IP - internet protocol

• IPC - in process control

• IPC - incidental patient contact

• IPCB (CDER) - Investigations and Preapproval Compliance Branch (CDER)

• IPCS - International Programme on Chemical Safety (WHO)

• IPEC - International Pharmaceutical Excipients Council

• IPM - Import Program Manager

• IPO - initial public offering

• IPOAB (CDRH) - Information Processing and Office Automation Branch (CDRH)

• IPPIA - International Plasma Products Industry Association

• IPRMS (OC) - International Planning and Resource Management Staff (OC)

• IPRO - Independent Pharmaceutical Research Organization

• IPS (OC) - IMPAC Program Staff (OC)

• IPS (OC) - International Policy Staff (OC)

• IPT - Integrated Project Team

• IPU - Irish Pharmaceutical Union

• IPV - inactivated poliovirus vaccine

• IQ - installation qualification

• IQA - Institute of Quality Assurance (UK)

• IQMP - Integrated Quality Management Plan

• IR - immediate release

• IR - information request

• IRA - immediate response authority

• IRA - Investigational and Related Application

• IRB - Institutional Review Board

• IRB - Investigational Review Board

• IRC - impact resistance lens certification (ORA AofC code)

• IRC - internet relay chat

• IRDM - insulin resistant diabetes mellitus

• IREAS (CDRH) - International Relations and External Affairs Staff (CDRH)

• IRIS - International Regulatory Issues Staff (ORA)

• IRM - information resources management

• IRMC - Information Resources Management College

• IRS - identical, related, or similar

• IRS - Incident Reporting System

• IRS - Internal Revenue Service (U.S. Department of the Treasury)

• IRS (OC) - International Relations Staff (OC)

• IRTA - Intramural Research Training Award (NIH)

• IS - ingredients statement

• IS - interstate commerce

• ISA - information systems architecture

• ISAC - Information Sharing and Analysis Center

• ISASS (OC) - International Scientific Activities and Standards Staff (OC)

• ISB (CDRH) - Inspection Support Branch (CDRH)

• ISBT - International Society of Blood Transfusion

• ISBT 128 - International Society of Blood Transfusion standard for blood, tissue, and organ identification

• ISDN - Integrated Services Digital Network

• ISE - integrated summary of efficiency

• ISIS - Import Support and Information System

• ISMP - Institute for Safe Medication Practices

• ISO - International Organization for Standardization

• ISP - internet service provider

• ISPE - International Society for Pharmaceutical Engineering

• ISPE - International Society for Pharmacoepidemiology

• ISR - Individual Safety Report

• ISS - Integrated Summary of Safety

• ISS/ISE - integrated summary of safety and effectiveness

• ISSO - information systems security officer

• IT - information technology

• ITA - International Trade Administration

• ITACS - Import Trade Auxiliary Communication System

• ITAS - Integrated Time and Attendance System

• ITATMT (OC) - IT Asset Tracking and Management Team (OC)

• ITB (CFSAN) - Immunotoxicology Branch (CFSAN)

• ITC - International Trade Commission (U.S.)

• ITCB (OC) - Information Technology Contracts Branch (OC)

• ITCC - Information Technology Coordinating Committee (CDER)

• ITDS - International Trade Data System

• ITF - Inspection Task Force (CBER)

• ITGS (OC) - IT Governance Staff (OC)

• ITIC - Information Technology Implementation Committee (CBER)

• ITIM - Information Technology Investment Management

• ITIPS - Information Technology Investment Portfolio System

• ITIRB - Information Technology Investment Review Board

• ITMRA - Information Technology Management Reform Act (now the Clinger-Cohen Act)

• ITS (CBER) - Information Technology Staff (CBER)

• ITT - intent to treat

• ITTT (OC) - IT Training Team (OC)

• IUO - investigation use only

• IUPAC - International Union of Pure and Applied Chemistry

• IV - intravenous

• IV & V - independent verification and validation

• IVC - inferior vena cava

• IVC - intravenous cholangiogram

• IVD - in vitro diagnostics

• IVF - in vitro fertilization

• IVIG - intravenous immunoglobulin

• IVMD - in vitro medical device

• IVP - intravenous pyelogram

• IVTB (CFSAN) - In Vitro Toxicology Branch (CFSAN)

• J-ART - Japanese Adverse Reaction Terminology

• J/D - judgment for the defendant

• JAD - joint application development

• JAN - Japanese Adopted Names

• JBIG - Joint Bi-level Image Experts Group

• JCAHO - Joint Commission on Accreditation of Health Care Organizations

• JECFA - Joint (FAO/WHO) Expert Committee on Food Additives

• JFHQ - Joint Force Headquarters

• JFO - Joint Field Office

• JFTR - Joint Federal Travel Regulations

• JIC - Joint Information Center

• JIFSAN - Joint Institute for Food Safety and Applied Nutrition

• JIFSAN (CFSAN) - JIFSAN Liaison Staff (CFSAN)

• JINAD - Generic Investigational New Animal Drug File

• JLCS (OC) - Jefferson Laboratory Complex Staff (OC)

• JMO - Japanese Maintenance Organization

• JMPR - Joint FAO/WHO Meeting of Pesticide Residues

• JP - Japanese Pharmacopoeia

• JPEG - Joint Photographic Experts Group

• JPMA - Japan Pharmaceutical Manufacturers Association

• JRIES - Joint Regional Information Exchange System

• JTF - Joint Task Force

• JTR - Joint Travel Regulations

• KAW - Keep Antibiotics Working

• kcal - kilocalories

• Kg - kilogram

• KMT (OC) - Knowledge Management Staff (OC)

• KOS - knowledge organization system

• KPS - Karnofsky Performance Status Scale

• KS - Kaposi's Sarcoma

• L & D - labor and delivery

• LABA - long-acting beta agonist

• LACF - low-acid canned foods

• LAF - laminar air flow

• LAN - local area network

• LanguaL - Langua Alimentaria (Language of Foods)

• LAR - licensing action recommendation

• LARD - licensing action recommendation document

• LARM - Licensing Action Recommendation Memorandum

• LASA - Linear Analog Self-Assessment Measure

• LASER - light amplification by stimulated emission of radiation

• LASIK - laser assisted in situ keratomileusis

• LATS - License Application Tracking System

• LBL - Ernest Orlando Lawrence Berkeley National Laboratory

• LBP (CBER) - Laboratory of Bacterial Polysaccharides (CBER)

• LBPUA (CBER) - Laboratory of Bacterial, Parasitic and Unconventional Agents (CBER)

• LBVB (CBER) - Laboratory of Biochemistry and Vascular Biology (CBER)

• LCDC - Laboratory Centre for Disease Control (Canada)

• LCH (CBER) - Laboratory of Cellular Hematology (CBER)

• LCI - Livestock Conservation Institute

• LCP (CDER) - Laboratory of Clinical Pharmacology (CDER)

• LCT (CFSAN) - Labeling Compliance Team (CFSAN)

• LD - lethal dose

• LD50 - lethal dose where 50% of the animal population die

• LDD - Lot Distribution Database

• LDPE - low-density polyethylene

• LDV (CBER) - Laboratory of DNA Viruses (CBER)

• LEAA - Law Enforcement Alliance of America

• LECC - Law Enforcement Coordination Committee

• LERN - Library Electronic Reference Network

• LES - leave and earnings statement

• LESTD (CBER) - Laboratory of Enteric and Sexually Transmitted Diseases (CBER)

• LF - low frequency

• LF1 - low-value food/food-related products less than or equal to $200 (ORA AofC code)

• LF2 - low-value food/food-related products greater than $200 and less than or equal to $500 (ORA AofC codes)

• LF3 - low-value food/food-related products greater than $500 and less than or equal to $1000 (ORA AofC code)

• LH (CBER) - Laboratory of Hemostasis (CBER)

• LHREA (CBER) - Laboratory of Hepatitis and Related Emerging Agents (CBER)

• LHV (CBER) - Laboratory of Hepatitis Viruses (CBER)

• LI - learned intermediary

• LIB (CBER) - Laboratory of Immunobiochemistry (CBER)

• LIMS - Laboratory Information Management System

• LIR (CBER) - Laboratory of Immunoregulation (CBER)

• Lm - Listeria monocytogenes

• LMD (CBER) - Laboratory of Method Development (CBER)

• LMDCI (CBER) - Laboratory of Mycobacterial Diseases and Cellular Immunology (CBER)

• LMDQC (CBER) - Laboratory of Methods Development and Quality Control (CBER)

• LMO - living modified organism

• LMS - Laboratory Management System

• LMV (CBER) - Laboratory of Molecular Virology (CBER)

• LNC - Labeling and Nomenclature Committee (CDER)

• LNE - Laboratoire National de Metrologie et d'Essias (National Laboratory of Metrology and Essays)

• LOA - letter of agreement

• LOAEL - Lowest Observed Adverse Effect Level

• LOB (ORA) - Laboratory Operations Branch (ORA)

• LOC - level of concern

• LOCF - last observation carried forward

• LOD - limit of detection

• LOEL - Lowest Observed Effect Level

• LOI - Letter of Intent

• LOINC - Logical Observation Identifier Name Codes (Regenstrief Institute)

• LOQ - limit of quantification

• LOV - list of values (EASE)

• LPB (OC) - Leasing and Policy Branch (OC)

• LPD (CBER) - Laboratory of Plasma Derivatives (CBER)

• LPET (CFSAN) - Laboratory Proficiency and Evaluation Team (CFSAN)

• LPRVD (CBER) - Laboratory of Pediatric and Respiratory Viral Diseases (CBER)

• LPT (CFSAN) - Liaison and Policy Team (CFSAN)

• LR (CBER) - Laboratory of Retroviruses (CBER)

• LR1 - low-value non-Rx radiation-emitting products less than or equal to $200 (ORA AofC code)

• LR2 - low-value non-Rx radiation-emitting products greater than $200 and less than or equal to $1000 (ORA AofC code)

• LRA - local registration authority

• LRB (CDER) - Labeling Review Branch (CDER)

• LRC - Lipid Research Clinic

• LRI - lower respiratory infection

• LRIS - Lot Release Imaging System

• LRIT (CFSAN) - Labeling Regulations Implementation Team (CFSAN)

• LRN - Laboratory Response Network (CDC)

• LRP - low regulatory priority

• LRPDB (CDRH) - Labeling Research and Policy Development Branch (CDRH)

• LRS - Lot Release System

• LRSP (CBER) - Laboratory of Respiratory and Special Pathogens (CBER)

• LS - Labelling Standard (Canada)

• LS (CDRH) - Library Staff (CDRH)

• LS/LS - life supporting/life sustaining

• LSD - Lysergic acid diethylamide

• LSHLC - lipid soluble heat labile chemicals

• LSHSC - lipid soluable heat stable chemical

• LST - device listing number (ORA AofC code)

• LTE - less than effective

• LUACRG - Lung and Upper Aerodigestive Cancer Research Group

• LVBD (CBER) - Laboratory of Vector-Borne Diseases (CBER)

• LVCH - local voucher

• LVP - Large-Volume Parenteral – an injection product having a solution volume which exceeds 100 mL

• LWC - electrode lead wire or patient cable (ORA AofC code)

• LWOP - leave without pay

• M&IE - miscellaneous and incidental expenses

• M2 - ICH M2 Expert Working Group (EWG) electronic standards for transmission of regulatory information

• M204 - Model 204 Database Management System (Computer Corporation of America)

• M4 - ICH M4 Expert Working Group (EWG) focusing on Common Technical Documents for sections of the NDA

• MA - Marketing Authorisation

• MAA - Marketing Authorisation Application

• mAb - monoclonal antibody

• MAB (CDER) - Management Analysis Branch (CDER)

• MAB (CFSAN) - Methods Application Branch (CFSAN)

• MAC - Mental Adjustment to Cancer Scale

• MACE - major adverse cardiac event(s)

• MACMIS - Marketing, Advertising and Communication Management Information System

• MACS (CBER) - Manufacturers Assistance and Communications Staff (CBER)

• MAD - multiple ascending dose

• MAH - Marketing Authorisation Holder (EC)

• MAPCB (CDER) - Manufacturing Assessment & Pre-Approval Compliance Branch (CDER)

• MAPP - Manual of Policy and Procedures

• MARCS - Mission Accomplishment and Regulatory Compliance Services System (ORA)

• MARS - Mobile Automated Regulatory Services (ORA)

• MAS cell - manipulated autologous structural cell

• MAT - modular antigen transporter

• MATS - Management Assignment Tracking System

• MATTB (CBER) - Manufacturers Assistance and Technical Training Branch (CBER)

• MAUDE - Manufacturer and User Facility Device Experience Database (CDRH)

• MAV - maximum allowable variation

• MB (CFSAN) - Microanalytical Evaluations Branch (CFSAN)

• MBC - minimum bactericidal concentration

• MCA - Medicines Control Agency (part of MHRA)

• mCAFT - Modified Canadian Aerobic Fitness Test

• MCM - medical countermeasure

• MCMi - Medical Countermeasures initiative

• MCO - managed care organization

• MDA - Medical Device Amendments of 1976

• MDA - Medical Devices Agency (UK)

• MDB - Medical Devices Bureau (Canada)

• MDB (CFSAN) - Methods Development Branch (CFSAN)

• MDD - maximum daily dose

• MDD - Medical Devices Directives (EU)

• MDDRP - Medical Device Dispute Resolution Panel

• MDI - metered dose inhaler

• MDII - Medical Device Innovation Initiative

• MDL - model number (ORA AofC code)

• MDMA - Medical Device Manufacturers Association

• MDP - Medical Devices Program (Canada)

• MDR - medical device reporting

• MDR TB - multi-drug resistant tuberculosis

• MDSAP - Medical Device Single Audit Program

• MDUFA - Medical Device User Fee Amendments of 2007

• MDUFMA - Medical Device User Fee and Modernization Act of 2002

• MDUFSA - Medical Device User Fee Stabilization Act of 2005

• MDV - medical device vigilance

• MedDRA - Medical Dictionary for Regulatory Activities

• MEDEC - Medical Devices Canada

• MEDLARS - Medical Literature Analysis and Retrieval System (NLM)

• MedPAC - Medicare Payment Advisory Commission

• MEDSA - The Medicine Equity and Drug Safety Act of 2000

• MedSuN - Medical Product Safety Network (CDRH)

• MEDWATCH - FDA Safety Information and Adverse Event Reporting Program

• MEFA - Association of the Danish Pharmaceutical Industry

• MEG - magnetoencephalography

• MEMO - Medicines Evaluation and Monitoring Organization

• MEO - most efficient organization

• MERCOSUR - Southern Common Market (South America)

• MERP - Medication Error Reporting and Prevention

• MERS-CoV - Middle East Respiratory Syndrome coronavirus

• MERS-TM - Medical Event Reporting System - Transfusion Medicine

• MeSH - Medical Subject Headings

• MF - master file

• MFA - medicated feed application number (ORA AofC code)

• MFC - Model Food Code

• mfr - manufacturer

• MFRPS - Manufactured Food Regulatory Program Standards

• MGB (CFSAN) - Molecular Genetics Branch (CFSAN)

• MGSS - multi-generation support system

• MHPF - Minority Health Professionals Foundation

• MHRA - Medicines and Healthcare products Regulatory Agency (UK)

• MHSB (CFSAN) - Microbial Hazards Science Branch (CFSAN)

• MHW - Ministry of Health and Welfare (Japan's equivalent to the FDA)

• MI - myocardial infarction

• MIC - minimum inhibitory concentration

• MID - manufacturer identifier (CBP)

• MIP - Management Improvement Plan

• MIRA - Medicare Innovation Responsiveness Act of 2003

• MIS - Management Information System

• MIS (OC) - Management Initiatives Staff (OC)

• MIWG - Mentoring Implementation Working Group

• MJ - major amendment

• ML - manufacturer's license (UK pharmaceuticals)

• MLD - minimum lethal dose

• MMA - Medicare Prescription Drug, Improvement and Modernization Act of 2003

• MMAB (CFSAN) - Microbiological Methods Application Branch (CFSAN)

• MMDB (CFSAN) - Microbial Methods Development Branch (CFSAN)

• MMR - measles, mumps and rubella

• MMRB (CFSAN) - Microbiological Methods Research Branch (CFSAN)

• MMSB (CFSAN) - Molecular Methods and Subtyping Branch (CFSAN)

• MMWR - Morbidity and Mortality Weekly Report - published by the CDC.

• MNVP - medically necessary veterinary product

• MOA - memorandum of agreement

• MOA - mode of action

• MOC - Management and Operations Council (FDA)

• MOC - Memorandum of Conference

• MOD - miscellaneous obligation document

• MOD 1 - Module One (laboratory facility - CFSAN)

• MOD 2 - Module Two (laboratory facility - CVM)

• MON - memorandum of need

• MOU - memorandum of understanding

• MPA - Medical Products Agency (Sweden)

• MPA - multiple projects (human subjects) assurance

• MPAB (OC) - Management Programs and Analysis Branch (OC)

• MPC - Medical Policy Council

• MPCC - Medical Policy Coordinating Committee

• MPEG - Moving Pictures Experts Group

• MPN - Metro Park North

• MPQA - medical products quality assurance

• MPR - moisture protein ratio

• MPRIS - Mammography Program Reporting and Information Systems

• MQC - mammography quality control

• MQSA - Mammography Quality Standards Act of 1992

• MRA - magnetic resonance angiography

• MRA - medical research associate

• MRA - mutual recognition agreement

• MRB - Material Review Board (American National Red Cross)

• MRB (CFSAN) - Methods Research Branch (CFSAN)

• MRC - Managed Review Committee

• MRC - Medical Reserve Corps (U.S. Public Health Service)

• MRD - multiple rising dose

• MRE - meal, ready-to-eat

• MRFG - Mutual Recognition Facilitating Group

• MRI - magnetic resonance imaging

• MRL - maximum residue limit

• MRP - manufacturing resource planning

• MRRA (CFSAN) - Microbial Research and Risk Assessment Staff (CFSAN)

• MRS - magnetic resonance spectroscopy

• MRTD - Maximum Recommended Therapeutic Dose

• MRTP - Modified Risk Tobacco Products

• MS - mass spectroscopy

• MS - milestone

• MSAB (CFSAN) - Manufacturing and Storage Adulteration Branch (CFSAN)

• MSB (NCTR) - Mass Spectrometry Branch (NCTR)

• MSDS - Material Safety Data Sheets

• MSI - magnetic source imaging

• MSQA - Mammography Quality Standards Act of 1992

• MSS (CVM) - Management Support Staff (CDRH)

• MSSO - Maintenance and Support Services Organization

• MT (CFSAN) - Medical Team (CFSAN)

• MTA - mail transport agent

• MTA - material transfer agreement

• MTBF - mean time between failures

• MTCT - Mother-to-child transmission

• MTD - maximum tolerated dose

• MTOS (CFSAN) - Muirkirk Technical Operations Staff (CFSAN)

• MUMS - minor use minor species

• MUMS (CVM) - Office of Minor Use and Minor Species (CVM)

• MUMS Act - Minor Use and Minor Species Animal Health Act of 2004

• MVB (CFSAN) - Molecular Virology Branch (CFSAN)

• MVT (CFSAN) - Molecular Virology Team (CFSAN)

• MW+ - MedWatch Plus

• MWG - Milk Working Group

• n.b. - nota bene (note well)

• N/A - not applicable

• NA - not approvable

• NAA - National Aquaculture Association

• NABR - National Association for Biomedical Research

• NACCHO - National Association of County and City Health Officials

• NACDS - National Association of Chain Drug Stores

• NACHO - National Association of County Health Officials

• NACMCF - National Advisory Committee on Microbiological Criteria for Foods

• NAD - ned animal drug number (ORA AofC code)

• NADA - new animal drug application

• NADE - New Animal Drug Evaluation

• NAET (CFSAN) - Nutrition Assessment and Evaluation Team (CFSAN)

• NAF - notice of adverse findings

• NAFTA - North American Free Trade Agreement

• NAGC - National Association of Government Communicators

• NAHC - National Advisory Health Council

• NAHMS - National Animal Health Monitoring System

• NAI - no action indicated

• NAION - non-arteritic anterior ischemic optic neuropathy

• NAL - National Agricultural Library

• NALBOH - National Association of Local Boards of Health

• NAM - National Agency for Medicines (Finland)

• NARA - National Archives and Records Administration (U.S.)

• NARB - National Advertising Review Board (FTC)

• NARMS - National Antimicrobial Resistance Monitoring System (CDC)

• NAS - National Academy of Sciences (U.S.)

• NAS - new active substance

• NASA - National Aeronautics and Space Administration (U.S.)

• NASAR - National Association of Search and Rescue

• NASDA - National Association of State Departments of Agriculture

• NASS - National Agricultural Statistics Survey

• NAT - nucleic acid-based tests

• NBAC - National Bioethics Advisory Commission

• NBCS - National Biomedical Computer System (American National Red Cross)

• NBDRC - National Blood Data Resource Center

• NBII - National Biological Information Infrastructure

• NBS - National Bureau of Standards (now NIST)

• NC - non-clinical (phase, studies)

• NCAB - National Cancer Advisory Board

• NCBA - National Cattlemen's Beef Association

• NCBDDD - National Center on Birth Defects and Developmental Disabilities (CDC)

• NCBI - National Center for Biotechnology Information (NCI)

• NCC - National Chicken Council

• NCC - National Coordinating Committee

• NCC MERP - National Coordinating Council for Medication Error Reporting and Prevention

• NCCAM - National Center for Complementary and Alternative Medicine (NIH)

• NCCDPHP - National Center for Chronic Disease Prevention and Health Promotion (CDC)

• NCCLS - National Committee for Clinical Laboratory Standards (now CLIS)

• NCDCP - National Council on Prescription Drug Programs

• NCE - new chemical entity

• NCEH - National Center for Environmental Health (CDC)

• NCFST - National Center for Food Safety and Technology

• NCHGR - National Center for Human Genome Research (NIH)

• NCHM - National Center for Health Marketing (CDC)

• NCHS - National Center for Health Statistics (CDC)

• NCHSTP - National Center for HIV, STD, and TB Prevention (CDC)

• NCI - National Cancer Institute (NIH)

• NCID - National Center for Infectious Diseases (CDC)

• NCIE - National Center for Import and Export (USDA)

• NCIE - Notice of Claimed Investigational Exemption (CVM)

• NCIMS - National Conference on Interstate Milk Shipments

• NCIPC - National Center for Injury Prevention and Control (CDC)

• NCL - National Consumers League

• NCMHD - National Center on Minority Health and Health Disparities (NIH)

• NCNR - National Center for Nursing Research (NIH)

• NCP - nonconforming product

• NCPDP - National Council for Prescription Drug Programs

• NCPHI - National Center for Public Health Informatics (CDC)

• NCPIE - National Council on Patient Information and Education

• NCR - Non-Conformance Report

• NCRP - National Council on Radiation Protection and Measurements

• NCRR - National Center for Research Resources (NIH)

• NCS - National Communications System

• NCS - not clinically significant

• NCT - National Clinical Trial

• NCTR - National Center for Toxicological Research (FDA)

• NCVHS - National Committee on Vital and Health Statistics (DHHS)

• NCVIA - National Childhood Vaccine Injury Act of 1986

• NCWM - National Conference on Weights and Measures

• NDA - new drug application

• NDA - new drug application number (ORA AofC code)

• NDAB - National Drugs Advisory Board (Ireland)

• NDAC - Nonprescription Drug Advisory Committee

• NDC - National Drug Code (FDA)

• NDE - new drug evaluation

• NDE/MIS - New Drug Evaluation Management Information System

• NDF-RT - National Drug File Reference Terminology (VA)

• NDIRS (CFSAN) - New Dietary Ingredients Review Staff (CFSAN)

• NDMA - Nonprescription Drug Manufacturers Association (now CHPA)

• NDMS - National Disaster Medical System

• NDMS (CDER) - New Drug Microbiology Staff (CDER)

• NDRMMP - National Drug Residue Milk Monitoring Program

• NDS - new drug study

• NDS - New Drug Submission (Canada)

• NDTI - National Disease and Therapeutic Index

• NE-FO (ORA) - Regional Field Office, Northeast Region

• NEC - not elsewhere classified

• NEDSS - National Electronic Disease Surveillance System (CDC)

• NEEP - National Exercise and Evaluation Program

• NEFARMA - Dutch Association of the Innovative Pharmaceutical Industry

• NEFLE - National Exchange for Food Labeling Education

• NEHA - National Environmental Health Association

• NEI - National Eye Institute (NIH)

• NEMA - National Electrical Manufacturers Association

• NEMA - National Emergency Management Association

• NEP - National Exercise Program (Department of Homeland Security)

• NEPA - National Environmental Policy Act

• NetBEUI - NetBIOS extended user interface

• NEXT - Nationwide Evaluation of X-ray Trends (CDRH)

• NF - National Formulary

• NFPA - National Food Processor Association

• NFSS - National Food Safety System

• NFT - notification of foreign travel

• NGA - National Geospatial-Intelligence Agency

• NGB - National Guard Bureal

• NGFA - National Grain and Feed Association

• NGO - non-governmental organization

• NGS - Next-generation Sequencing

• NHANES - National Health and Nutrition Examination Survey (NCHS)

• NHC - National Hurricane Center

• NHF - National Hemophilia Foundation

• NHGRI - National Human Genome Research Institute (NIH)

• NHIC - National Health Information Center (DHHS)

• NHIN - Nationwide Health Information Network

• NHIS - National Institute of Hygienic Sciences (Japan)

• NHLBI - National Heart, Lung, and Blood Institute (NIH)

• NHP - Non-human Primate

• NHRIC - national health related items code (CDRH)

• NHW - National Health and Welfare Department (Canada's equivalent of DHHS)

• NIA - National Institute on Aging (NIH)

• NIAAA - National Institute on Alcohol Abuse and Alcoholism (NIH)

• NIAID - National Institute of Allergy and Infectious Disease (NIH)

• NIAMS - National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIH)

• NIBIB - National Institute of Biomedical Imaging and Bioengineering (NIH)

• NICCL - National Incident Communications Conference Line

• NICE - National Institute for Health and Clinical Excellence (UK)

• NICHD - National Institute of Child Health and Human Development (NIH)

• NIDA - National Institute on Drug Abuse (NIH)

• NIDCD - National Institute on Deafness and Other Communication Disorders (NIH)

• NIDCR - National Institute of Dental and Craniofacial Research (NIH)

• NIDDK - National Institute of Diabetes and Digestive and Kidney Diseases (NIH)

• NIDPOE - Notice of Initiation of Disqualification Proceeding and Opportunity to Explain

• NIDR - National Institute of Dental Research (see NIDCR)

• NIDRR - National Institute on Disability and Rehabilitation Research (U.S. Department of Education)

• NIEHS - National Institute of Environmental Health Sciences (NIH)

• NIFC - National Interagency Fire Center

• NIGMS - National Institute of General Medical Sciences (NIH)

• NIH - National Institutes of Health (DHHS)

• NIM - no inspection made

• NIMH - National Institute of Mental Health (NIH)

• NIMS - National Incident Management System (FEMA)

• NINDS - National Institute of Neurological Disorders and Stroke (NIH)

• NINR - National Institute of Nursing Research (NIH)

• NIOSH - National Institute for Occupational Safety and Health (CDC)

• NIP - National Immunization Program (CDC)

• NIPP - National Infrastructure Protection Plan

• NIS - National Inpatient Sample

• NISAC - National Infrastructure Simulation and Analysis Center (Department of Homeland Security)

• NIST - National Institute of Standards and Technology (U.S. Department of Commerce)

• NKCA - natural killer cell cytotoxic activity

• NLEA - Nutrition Labeling and Education Act of 1990

• NLM - National Library of Medicine (NIH)

• NLN - Nordic Council on Medicines

• NLRC - Nicholson Lane Research Center

• NLT - not less than

• NMA - National Medical Association

• NMDP - National Marrow Donor Program

• NME - new molecular entity

• NMFS - National Marine Fisheries Service

• NMI - non-medicinal ingredient

• NMPF - National Milk Producers Federation

• NMQAAC - National Mammography Quality Assurance Advisory Committee

• NMR - nuclear magnetic resonance spectroscopy

• NMT - not more than

• NNC - National Notification Center

• NNMC - National Naval Medical Center

• NNRTI - non-nucleoside reverse transcriptase inhibitor

• NOA - Notice of Availability

• NOAA - National Oceanographic and Atmospheric Administration (U.S.)

• NOAEL - no observable adverse effect level

• NOC - National Operations Center

• NOC - Notice of Compliance (Canada)

• NOD - Notice of Deficiency (Canada)

• NOEL - no observed effect level

• NOH - notice of hearing

• NOMI - Federation of Norwegian Pharmaceutical Manufacturers

• NON - notice of non-compliance (Canada)

• NONS - Notification of New Substance Regulations 193 (EC)

• NOOH - notice offering an opportunity for a hearing

• NOP - National Organic Program

• NOS - network operating system

• NOSB - National Organic Standards Board

• NOV - notice of violation letter

• NPA - National Pharmaceutical Association (UK)

• NPA - National Prescription Audit

• NPCC - National Poison Control Center

• NPCR - National Program of Cancer Registries

• NPG - National Preparedness Goal

• NPI - national provided identifier (CMS)

• NPPC - National Pork Producers Council

• NPR - National Performance Review

• NPRM - notice of proposed rulemaking

• NPS - National Park Service (Department of the Interior)

• NPS - National Pharmaceutical Stockpile(CDC)

• NPS (CFSAN) - Nutrition Programs Staff (CFSAN)

• NPSB (CFSAN) - Nutritional Product Studies Branch (CFSAN)

• NR - non-compliance record

• NR - response to not approvable letter

• NRB - Noninstitutional Review Board

• NRC - National Research Council

• NRC - Nuclear Regulatory Commission (U.S.)

• NRCC - National Response Coordination Center

• NREVSS - National Respiratory and Enteric Virus Surveillance System

• NRP - National Response Plan (Department of Homeland Security)

• NRP-CIS - National Response Plan Catastrophic Incident Supplement

• NRSP - National Research Support Project

• NRTE - not ready-to-eat

• NS - Not significant

• NS/EP - National Security and Emergency Preparedness

• NSA - National Security Agency (U.S.)

• NSAID - Non-Steroidal Anti-Inflammatory Drug

• NSAPB - National Surgical Adjuvant Breast and Bowel Project

• NSAPE - North American Society for Pacing and Electrophysiology

• NSC - National Security Council

• NSE - not substantially equivalent

• NSF - National Science Foundation (U.S.)

• NSIP - National Seafood Inspection Program

• NSN - national stock number

• NSR - nonsignificant risk

• NSRT (CFSAN) - Nutrition Science Review Team (CFSAN)

• NSV-DO (ORA) - Nashville (Tennessee) District Office (ORA)

• NSWL - Naval Surface Weapons Laboratory (now FDA White Oak campus)

• NTA - notice to applicants (EC)

• NTB (CFSAN) - Neurotoxicology Branch (CFSAN)

• NTEU - National Treasury Employees Union

• NTF - National Turkey Federation

• NTG - nitroglycerin

• NTI - narrow therapeutic index

• NTIA - National Telecommunications and Information Administration (U.S.)

• NTIS - National Technical Information Service

• NTL - National Testing Laboratory (American National Red Cross)

• NTP - National Toxicology Program (U.S.)

• NUCC - National Uniform Claim Committee (AMA and HCFA)

• NVC - National Vaccine Commission

• nvCJD - new variant Creutzfeldt-Jakob Disease

• NVICP - National Vaccine Injury Compensation Program

• NVLAP - National Voluntary Laboratory Accreditation Program (NIST)

• NVOAD - National Volunteer Organizations Active in Disaster

• NVP - National Vaccine Program

• NVPO - National Vaccine Program Office (DHHS)

• NVSS - National Vital Statistics System

• NVTB (CFSAN) - Neurotoxicological and In Vitro Toxicology Branch (CFSAN)

• NWK-DO (ORA) - Newark District Office (ORA)

• NWR - NOAA Weather Radio

• NWS - National Weather Service

• OA - Office of Administration (Office of the Commissioner)

• OA - osteoarthritis

• OAGS (OC) - Officeof Acquisitions and Grants Services (OC)

• OAI - official action indicated

• OAP (CDER) - Office of Antimicrobial Products (CDER)

• OARSA (CFSAN) - Office of Applied Research and Safety Assessment (CFSAN)

• OASDI - Old Age, Survivors, and Disability Insurance

• OASH - Office of the Assistant Secretary for Health (DHHS)

• OASIS - Operational and Administrative System for Import Support (CFSAN)

• OB (CDER) - Office of Biostatistics (CDER)

• OB-GYN - obstetrics-gynecology

• OBA - Office of Biotechnology Activities (NIH)

• OBE - online booking engine

• OBE (CBER) - Office of Biostatistics and Epidemiology (CBER)

• OBES (OC) - Office of Business Enterprise Solutions (OC)

• OBFP (OC) - Office of Budget Formulation and Presentation (OC)

• OBI (CDER) - Office of Business Informatics (CDER)

• OBP (CDER) - Office of Biotechnology Products (CDER)

• OBPS (CDER) - Office of Business Process Support (CDER)

• OBRR (CBER) - Office of Blood Research and Review (CBER)

• OC - Immediate Office of the Commissioner (OC)

• OC - Office of Compliance

• OC - Office of the Commissioner (FDA)

• OC (CDER) - Office of Compliance (CDER)

• OC (CDRH) - Office of Compliance (CDRH)

• OC (CFSAN) - Office of Compliance (CFSAN)

• OCAC (CFSAN) - Office of Cosmetics and Colors (CFSAN)

• OCBQ (CBER) - Office of Compliance and Biologics Quality (CBER)

• OCC - object class code

• OCC (OC) - Office of the Chief Counsel (OC)

• OCD (CDRH) - Office of the Center Director (CDRH)

• OCD (CFSAN) - Office of the Center Director (CFSAN)

• OCD (CVM) - Office of the Center Director (CVM)

• OCER (CDRH) - Office of Communication, Education and Radiological Programs (CDRH)

• OCET (OC) - Office of Counterterrorism and Emerging Threats (OC)

• OCI (ORA) - Office of Criminal Investigations (ORA)

• OCIO (OC) - Office of the Chief Information Officer (OC)

• OCM (OC) - Office of Crisis Management (OC)

• OCO (CFSAN) - Office of Constituent Operations (CFSAN)

• OCOD - Office of Communication Outreach and Development (CBER)

• OCOMM (CDER) - Office of Communications (CDER)

• OCP (CDER) - Office of Clinical Pharmacology (CDER)

• OCP (OC) - Office of Combination Products (OC)

• OCPP - Office of Critical Path Programs

• OCR - Office for Civil Rights (DHHS)

• OCS - Office of the Chief Scientist (OC)

• OCTC (OC) - Office of the Counselor to the Commissioner (OC)

• OCTEC (CDER) - Office of Counter-terrorism and Emergency Coordination (CDER)

• OCTGT (CBER) - Office of Cellular, Tissue and Gene Therapies (CBER)

• OCTMA (CBER) - Office of Communication, Training and Manufacturers Assistance (CBER)

• OD - Office of the Director

• OD - once daily

• OD (CBER) - Office of the Director (CBER)

• OD (CDER) - Office of the Center Director (CDER)

• OD (NCTR) - Office of the Director (NCTR)

• ODA - Orphan Drug Act of 1983

• ODAC - Oncologic Drugs Advisory Committee

• ODE - Office of Drug Evaluation (CDER)

• ODE (CDRH) - Office of Device Evaluation (CDRH)

• ODE I - Office of Drug Evaluation I (CDER)

• ODE II - Office of Drug Evaluation II (CDER)

• ODE III - Office of Drug Evaluation III (CDER)

• ODE IV (CDER) - Office of Drug Evaluation IV (CDER)

• ODM - operational data model (CDISC)

• ODSIR (CDER) - Office of Drug Security, Integrity, and Recalls (CDER)

• OE (ORA) - Office of Enforcement (ORA)

• OEA (OC) - Office of External Affairs (OC)

• OECD - Organisation for Economic Co-operation and Development

• OEEODEM (OC) - Office of EEO and Diversity Management (OC)

• OEI - Official Establishment Inventory

• OEIO (ORA) - Office of Enforcement and Import Operations (ORA)

• OEL - occupational exposure level

• OEM - original equipment manufacturer

• OEO (OC) - Office of Executive Operations (OC)

• OEP - Office of Emergency Preparedness (PHS)

• OEP (CDER) - Office of Executive Programs (CDER)

• OER (OC) - Office of External Relations (OC)

• OES (OC) - Office of Executive Secretariat (OC)

• OEXA - Office of External Affairs (OC)

• OFACS - Office of Facilities, Acquisitions, and Central Services (FDA)

• OFAS (CFSAN) - Office of Food Additive Safety (CFSAN)

• OFDA - Office of Foreign Disaster Assistance

• OFDCER (CFSAN) - Office of Food Defense, Communication and Emergency Response (CFSAN)

• OFFAS (OC) - Office of Field Financial and Acquisitions Services (OC)

• OFM (OC) - Office of Financial Management (OC)

• OFPA - Organic Foods Production Act of 1990

• OFS (CFSAN) - Office of Food Safety (CFSAN)

• OFS (OC) - Office of Financial Services (OC)

• OFSDO (CFSAN) - Office of Food Safety, Defense and Outreach (CFSAN)

• OGC - Office of the General Counsel (DHHS)

• OGD (CDER) - Office of Generic Drugs (CDER)

• OGE - Office of Government Ethics (U.S.)

• OGROP (OC) - Office of Global Regulatory Operations and Policy (OC)

• OGUD (CDRH) - Obstetrics and Gynecology Devices Branch (CDRH)

• OHCA (OC) - Office of Health and Constituent Affairs (OC) (formerly Office of Special Health Issues - OSHI)

• OHRMS - Office of Human Resources and Management Services (FDA)

• OIA (OC) - Office of Internal Affairs (OC)

• OIASI (OC) - Office of International Activities and Strategic Initiatives (OC)

• OIG - Office of Inspector General (DHHS)

• OIM - Office of Information Management (OC)

• OIP (OC) - Office of International Programs (OC)

• OIRA - Office of Information and Regulatory Affairs (OMB)

• OIT (CBER) - Office of Information Technology (CBER)

• OIT (CDER) - Office of Information Technology (CDER)

• OIT (CDRH) - Office of Information Technology (CDRH)

• OIT (CFSAN) - Office of Information Technology (CFSAN)

• OIT (CVM) - Office of Information Technology (CVM)

• OIT (NCTR) - Office of Information Technology (NCTR)

• OIT (OC) - Office of Information Technology (OC)

• OIT (ORA) - Office of Information Technology (ORA)

• OITSS (OC) - Office of Information Technology Shared Services (OC)

• OIVD (CDRH) - Office of In Vitro Diagnostic Device Evaluation and Safety (CDRH)

• OJDB (CDRH) - Orthopedic Joint Devices Branch (CDRH)

• OLA (OC) - Office of Legislative Affairs (OC)

• OLE - object linking and embedding (Microsoft)

• OM (CBER) - Office of Management (CBER)

• OM (CDER) - Office of Management (CDER)

• OM (CVM) - Office of Management (CVM)

• OM (OC) - Office of Management (OC)

• OMB - Office of Management and Budget (U.S.)

• OMB (NCTR) - Operations and Maintenance Branch (NCTR)

• OMH (OC) - Office of Minority Health (OC)

• OMO (CDRH) - Office of Management Operations (CDRH)

• OMP (CDER) - Office of Medical Policy (CDER)

• OMP (OC) - Office of Management Programs (OC)

• OMPQ (CDER) - Office of Manufacturing and Product Quality (CDER) (formerly Division of Manufacturing and Product Quality - DMPQ)

• OMPT - Office of Medical Products and Tobacco

• OMRF - Oklahoma Medical Research Foundation

• OMS (CFSAN) - Office of Management Systems (CFSAN)

• OMS (NCTR) - Office of Management Services (NCTR)

• OMT - oral mucosal transudate

• ONADE (CVM) - Office of New Animal Drug Evaluation (CVM)

• ONC - Office of the National Coordinator for Health Information Technology (DHHS)

• ONCHIT - Office of the National Coordinator for Health Information Technology (DHHS)

• OND (CDER) - Office of New Drugs (CDER)

• ONDQA (CDER) - Office of New Drug Quality Assessment (CDER)

• ONLDS (CFSAN) - Office of Nutrition, Labeling and Dietary Supplements (CFSAN)

• ONP (CDER) - Office of Nonprescription Products (CDER)

• ONPLDS (CFSAN) - Office of Nutritional Products, Labeling and Dietary Supplements (CFSAN)

• OO (CFSAN) - Office of Operations (CFSAN)

• OO (OC) - Offffice of the Ombudsman (OC)

• OO (OC) - Office of Operations (OC)

• OOB - out of business

• OODP (CDER) - Office of Oncology Drug Products (CDER)

• OOP - order of predominance in the ingredients statement

• OOPD - Office of Orphan Products Development

• OOS - out of specification

• OP (OC) - Office of Policy (OC)

• OP 1 (OC) - Operations Team 1 (OC)

• OP 2 (OC) - Operations Team 2 (OC)

• OP 3 (OC) - Operations Team 3 (OC)

• OP 4 (OC) - Operations Team 4 (OC)

• OPA (CDER) - Office of Planning and Analysis (CDER)

• OPA (OC) - Office of Public Affairs (OC)

• OPB (ORA) - Operations and Policy Branch (ORA)

• OPD (OC) - Office of Orphan Products Development (OC)

• OPDFB (CFSAN) - Office of Plants, Dairy Foods and Beverages (CFSAN)

• OPDIV - operating division

• OPDP - Office of Prescription Drug Promotion (CDER) (formerly Division of Drug Marketing, Advertisement and Communications - DDMAC)

• OPF - Official Personnel Folder

• OPFIT (NCTR) - Office of Planning, Finance and Information Technology (NCTR)

• OPHEP - Office of Public Health Emergency Preparedness (HHS)

• OPHEP - Office of Public Health Emergency Preparedness (HHS)

• OPI (CDER) - Office of Planning and Informatics (CDER)

• OPL (OC) - Office of Planning (OC)

• OPM - Office of Personnel Management (U.S.)

• OPMAD (CDRH) - Orthopedic Physical Medicine and Anesthesiology Devices Branch (CDRH)

• OPO - Organ Procurement Organization

• OPPL (OC) - Office of Policy, Planning and Legislation (OC)

• OPS (CDER) - Office of Pharmaceutical Science (CDER)

• OPT (OC) - Office of Pediatric Therapeutics (OC)

• OPTN - Organ Procurement and Transplantation Network

• OPV - oral polio vaccine

• OQ - operational qualification

• OR (CVM) - Office of Research (CVM)

• ORA - Office of Regulatory Affairs (FDA)

• ORA - operations research analyst

• ORADSS - Office of Regulatory Affairs Reporting, Analysis and Decision Support System

• Orange Book - Approved Drug Products with Therapeutic Equivalence Evaluations

• ORI - Office of Research Integrity (HHS)

• ORISE - Oak Ridge Institute for Science and Education

• ORL-DO (ORA) - Orlando District Office (ORA)

• ORM - operational risk management

• ORM - operational risk management

• ORM (ORA) - Office of Resource Management (ORA)

• ORNL - Oak Ridge National Laboratory

• ORO (ORA) - Office of Regional Operations (ORA)

• ORP (CDER) - Office of Regulatory Policy (CDER)

• ORP (CFSAN) - Office of Regulations and Policy (CFSAN)

• ORPS (OC) - Office of Real Property Services (OC)

• ORPSS (CFSAN) - Office of Regulations, Policy and Social Sciences (CFSAN)

• ORR - objective response rate

• ORS (CFSAN) - Office of Regulatory Science (CFSAN)

• OS (CDER) - Operations Staff (CDER)

• OS (CFSAN) - Office of Seafood (CFSAN)

• OS (OC) - Operations Staff (OC)

• OSAS (CFSAN) - Office of Scientific Analysis and Support (CFSAN)

• OSB (CDRH) - Office of Surveillance and Biometrics (CDRH)

• OSB (CFSAN) - Office Services Branch (CFSAN)

• OSC (CVM) - Office of Surveillance and Compliance (CVM)

• OSCAR - ORACLE System for Center Automation and Retrieval

• OSCI (CFSAN) - Office of Science (CFSAN)

• OSD-HD - Office of the Secretary of Defense for Homeland Defense

• OSDB (CDRH) - Orthopedic Spine Devices Branch (CDRH)

• OSE (CDER) - Office of Surveillance and Epidemiology (CDER)

• OSEL (CDRH) - Office of Science and Engineering Laboratories (CDRH)

• OSG - Office of the Surgeon General (PHS)

• OSHA - Occupational Safety and Health Administration (U.S. Department of Labor)

• OSHC (OC) - Office of Science and Health Coordination (OC)

• OSHC (OC) - Office of Science and Health Coordination (OC)

• OSHI (OC) - Office of Special Health Issues (OC)

• OSHRC - Occupational Safety and Health Review Commission (U.S.)

• OSI (CDER) - Office of Scientific Investigation (CDER) (formerly Division of Scientific Investigation - DSI)

• OSM - Office of Surface Mining (Department of the Interior)

• OSO (OC) - Office of Security Operations (OC)

• OSP (CDER) - Office of Strategic Programs (CDER) (formerly Office of Planning and Informatics)

• OSS (OC) - Office of Shared Services (OC)

• OST (CFSAN) - Office Services Team (CFSAN)

• OSTP - Office of Science and Technology Policy (U.S.)

• OTC - ornithine transcarbamylase deficiency

• OTC - over-the-counter

• OTCDHFB (CDER) - OTC Drugs and Health Fraud Branch (CDER)

• OTCOM (CDER) - Office of Training and Communications (CDER)

• OTFP - other than a food processing facility

• OTR (CDER) - Office of Testing and Research (CDER)

• OTRR (CBER) - Office of Therapeutics Research and Review (CBER)

• OTS (CDER) - Office of Translational Sciences (CDER)

• OUDLC (CDER) - Office of Unapproved Drugs and Labeling Compliance (CDER) (formerly Division of New Drugs and Labeling Compliance - DNDLC)

• OVI - organic volatile impurities

• OVRR (CBER) - Office of Vaccines Research and Review (CBER)

• OVST (CFSAN) - Operations and Veterinary Support Team (CFSAN)

• OWA - Outlook Web Access

• OWH (OC) - Office of Women's Health (OC)

• P & PC - production and process controls

• PA - physical activity

• PAAB - Pharmaceutical Advertising Advisory Board (Canada)

• PAB - Pharmaceutical Affairs Bureau (Japan)

• PAB (CFSAN) - Product Adulteration Branch (CFSAN)

• PAC - Political Action Committee

• PAC - post-approval changes

• PAC - private analytical certificate date (ORA AofC code)

• PAC - program assignment code

• PACE - Patient-centered Assessment and Counseling for Exercise

• PACT - Post-Approval Commitment Tracking

• PAD - pharmacologically active drug

• PADE - Postmarketing Adverse Drug Experience

• PADER - Periodic Adverse Drug Experience Report

• PAER - Preliminary Adverse Event Report Review (CDRH)

• PAFA - Priority-Based Assessment of Food Additives (CFSAN)

• PAG - Project Advisory Group

• PAGE - polyacrylimide gel electrophoresis

• PAH - Polycyclic Aromatic Hydrocarbon

• PAHO - Pan American Health Organization (WHO)

• PAHPRA - Pandemic and All-Hazards Preparedness Reauthorization Act

• PAI - pre-approval inspection

• PAIS (ORA) - Public Affairs and Information Staff (ORA)

• PAITS - Pre-Approval Inspection Tracking System

• PAL - public affairs liaison

• PAM - Pesticide Analytical Manual

• PAMP - Post-approval Monitoring System

• PAO - Public Affairs Office

• PAP - patient assistance programs

• PAR - proven acceptable range

• PARN - problem/action request notice

• PARQ - Physical Activity Readiness Questionnaire

• PARS (CDER) - Program Activities Review Staff (CDER)

• PART - Program Assessment Rating Tool

• PAS - prior approval supplement

• PAS - Public Affairs specialist

• PAS (CDRH) - Premarket Approval Section (CDRH)

• PAT - Process Analytical Technology Initiative (CDER)

• PATH - Population Assessment of Tobacco and Health

• PB (CDRH) - Planning Branch (CDRH)

• PBM - pharmacy benefits management

• PBPC - peripheral blood progenitor cell

• PBSC - peripheral blood stem cell

• PC - personal computer

• PC - Preventive Controls

• PCB - placental cord blood

• PCBE - President's Council on Bioethics

• PCBs - polychlorinated biphenyls

• PCC - Poison Control Center

• PCERT - Preclinical and Clinical Evaluation Review Template (Canada)

• PCP - phencycladine

• PCP - Pneumocystis carinii pneumonia

• PCR - polymerase chain reaction

• PCS - permanent change of station

• PCT - photochemical treatment

• PCT - practical clinical trial

• PD - pharmacodynamics

• PD - position description

• PDA - Parenteral Drug Association

• PDA - prescription drug advertising

• PDB (CDER) - Prescription Drugs Branch (CDER)

• PDCA - Plan-Do-Check-Act

• PDCS (OC) - Policy Development and Coordination Staff (OC)

• PDE - pediatric exclusivity

• PDE - permitted daily exposure

• PDF - portable document format

• PDI - post donation information

• PDLB (CDRH) - Pacing, Defibrillator and Leads Branch (CDRH)

• PDMA - Prescription Drug Marketing Act of 1988

• PDO - protected designation of origin

• PDP - principal display panel

• PDP - product development protocol

• PDQ - Physician Data Query (NCI)

• PDR - Physician's Desk Reference

• PDR - product defect reporting

• PDS - permanent duty station

• PDS (CDER) - Project Development Staff (CDER)

• PDUFA - Prescription Drug User Fee Act

• PE - pharmacoeconomics

• PE - physical education

• PEB (CBER) - Planning and Evaluation Branch (CBER)

• PEB (CDRH) - Program Enforcement Branch (CDRH)

• PEB (CFSAN) - Process Engineering Branch (CFSAN)

• PEB (CFSAN) - Program and Enforcement Branch (CFSAN)

• PEB (ORA) - Program Evaluation Branch (ORA)

• PEB 1 (CDRH) - Postmarket Evaluation Branch 1 (CDRH)

• PEB 2 (CDRH) - Postmarket Evaluation Branch 2 (CDRH)

• PELT (CFSAN) - Product Evaluation and Labeling Team (CFSAN)

• PEP - pancreatic enzyme product

• PEP - performance evaluation plan

• PEPFAR - Presidential Emergency Plan for AIDS Relief

• PER - Pharmaceutical Evaluation Reports (EMEA)

• Per Diem - per day (total allowance for daily travel expenses)

• PeRC - Pediatric Review Committee

• PERI - Pharmaceutical Education and Research Institute

• PERT - product-enhanced reverse transcriptase

• PERV - porcine endogenous retrovirus

• PET - polyethylene terephthalate

• PET - positron emission tomography

• PETA - People for the Ethical Treatment of Animals

• PETG - polyethylene terephthalate G

• PFGE - pulsed-field gel electrophoresis

• PFI - Pet Food Institute

• PFIPC - Permanent Forum on International Pharmaceutical Crime

• PFL - Professional Flexible Labeling

• PFO - Patent Foramen Ovale

• PFO - principal federal official

• PFS - Piper Fatigue Scale

• PGB (CFSAN) - Policy Guidance Branch (CFSAN)

• Ph. Eur. - Pharmacopeia Europa

• PHA - public health advisory

• PHEMCE - Public Health Emergency Medical Countermeasures Enterprise

• PHI - protected health information

• PHIN - Public Health Information Network (CDC)

• PHN - Population, Health and Nutrition (Center)

• PHPPO - Public Health Practice Program Office (CDC)

• PHPS - Public Health Prevention Service (CDC)

• PhRMA - Pharmaceutical Research and Manufacturers of America

• PHS - Public Health Service (DHHS)

• PHSA - Public Health Service Act of 1944

• PHTN - Public Health Training Network (CDC)

• PI - package insert (approved product labeling)

• PI - principal investigator

• PIB (CBER) - Program Inspection Branch (CBER)

• PIC/S - pharmaceutical inspection convention/pharmaceutical inspection co-operation scheme

• PICNIC - Professionals & Citizens Network for Integrated Care

• PIFSI - Produce and Imported Foods Safety Initiative (CFSAN)

• PIM - Product Information Management

• PIN - personal identification number

• PIP - Personal Importation Policy

• PIP - plant-incorporated protectant

• PIT - Process Improvement Team

• PIV - Personal Identify Verification

• PK - pharmacokinetics

• PKA - prekallikrein activator

• PKI - public key infrastructure

• PKLN - Parklawn Building

• PKU - phenylketonuria

• PLA - product license application (CBER)

• PLAIR - Pre-Launch Activities Importation Request

• PLAS - Prior Label Approval System (FSIS)

• PLF - Product Licensing Framework (Canada)

• PLI - pre-license inspection (CBER)

• PLLR - Pregnancy and Lactation Labeling Rule

• PLR - Physician Labeling Rule

• PLS - Pending Logging System

• PLS - product license application supplement

• PM - post-marketing

• PM - project manager

• PMA - device premarket approval number (ORA AofC code)

• PMA - Pharmaceutical Manufacturer's Association

• PMA - premarket application

• PMA - premarket approval

• PMAA - premarket approval application

• PMAP - Performance Management Appraisal Program

• PMB - pharmacy benefit manager

• PMC - postmarketing commitment

• PMCC - Project Management Coordinating Committee (CDER)

• PMF - public master file

• PMHS (CDER) - Pediatric and Maternal Health Staff (CDER)

• PMN - device premarket notification number (510k) (ORA AofC code)

• PMN - premarket notification

• PMO - Pasteurized Milk Ordinance

• PMO - project management officer

• PMOA - primary mode of action

• PMP - Performance Management Program

• PMP - plant-made pharmaceutical

• PMP - Project Management Professional

• PMPRB - Patented Medicine Prices Review Board (Canada)

• PMR - postmarketing requirement

• PMR - premarket report

• PMRI - patient medical record information

• PMRI - Preventive Medicine Research Institute

• PMS - postmarketing surveillance

• PMS (CDRH) - Program Management Staff (CDRH)

• PMS (OC) - Print Media Staff (OC)

• PMSB - Pharmaceutical and Medical Safety Bureau (Japan)

• PMSB (CBER) - Program Management Services Branch (CBER)

• PMSB (CDER) - Program Management Services Branch (CDER)

• PMSC - Pre-Market Surveillance and Compliance (CFSAN)

• PN - product name

• PNC (ORA) - Prior Notice Center (ORA)

• PNNL - Pacific Northwest National Laboratory

• PNR - passenger name record

• PNS - peripheral nervous system

• PNS (CDRH) - Premarket Notification Section (CDRH)

• PNSI - prior notice system interface

• PO - per os (by mouth)

• POA - privately owned automobile

• POB (CBER) - Program Operations Branch (CBER)

• POC - point of contact

• PODS - Program Oriented Data System

• PODS - Project Oriented Data System

• POM - prescription-only medicine (UK)

• POM - program objective memorandum

• POMS - profile of mood states

• POS - point of sale

• POS (CBER) - Program Operation Staff (CBER)

• POS (CDRH) - Program Operations Staff (CDRH)

• POV - privately-owned vehicle

• POWER - Petition Optical Workflow, Exchange and Retrieval (CFSAN's FARM System)

• PP - pay period

• PPA - phenylpropanolamine

• PPA - Poison Prevention Act

• ppb - parts per billion

• PPB (CFSAN) - Plant Products Branch (CFSAN)

• PPC - production and process controls

• PPE - pay period ending

• PPE - personal protective equipment

• PPI - patient package insert

• PPI - planned product improvements

• PPI - proton pump inhibitor

• PPIA - Poultry Products Inspection Act

• ppm - parts per million

• PPM - planned preventive maintenance

• PPP - point-to-point protocol

• PPQ - plant protection and quarantine (USDA)

• PPS (CBER) - Policy and Publications Staff (CBER)

• PPSR - Proposal for Pediatric Studies Request

• PPT - plasma preparation tube

• PPTA - Plasma Protein Therapeutics Association

• PPTP - point-to-point tunneling protocol (Microsoft)

• PPV - Patient Profile Viewer

• PPWMB (ORA) - Program Planning and Workforce Management Branch (ORA)

• PQ - performance qualification

• PQ - process qualification

• PQAS - Pharmaceutical Quality Assessment System

• PQG - Pharmaceutical Quality Group

• PQLS (CBER) - Product Quality Laboratory Staff (CBER)

• PQRI - Product Quality Research Institute

• PR - Public Relations

• PR - pulse rate

• PR (CBER) - Product Review Branch (CBER)

• PRA - Paperwork Reduction Act of 1995

• PRB - PDUFA Review Board

• PRB - Performance Review Board

• PRB (CBER) - Product Release Branch (CBER)

• PRB (CFSAN) - Pathology Branch (CFSAN)

• PREA - Pediatric Research Equity Act of 2003

• PRIM & R - Public Responsibility in Medicine and Research

• PRL-NW - Pacific Regional Laboratory - Northwest (ORA)

• PRL-SW - Pacific Regional Laboratory - Southwest (ORA)

• PRMB (CDER) - Program and Resources Management Branch (CDER)

• PRN - as needed

• PRO - patient-reported outcome

• Prop 65 - Proposition 65

• PrP - prion protein

• PRRB (OC) - Paperwork Reduction and Records Branch (OC)

• PRRMS (OC) - Paperwork Reduction and Records Management Staff (OC)

• PRS (OC) - Policy Research Staff (OC)

• PRSB (CDRH) - Plastic and Reconstructive Surgery Devices Branch (CDRH)

• PS - particle size

• PS (CDER) - Planning Staff (OC)

• PSA - Poultry Science Association

• PSA - prostate specific antigen

• PSB (CBER) - Program Surveillance Branch (CBER)

• PSC - Postmarket Strategies Committee

• PSC - Program Support Center (DHHS)

• PSD (OC) - Payment Services Division (OC)

• PSI - Pharmaceutical Society of Ireland

• PSN - Patient Safety News (FDA)

• PSNI - Pharmaceutical Society of Northern Ireland

• PSP - physician special pay

• PSS (CDRH) - Patient Safety Staff (CDRH)

• PSSB (CFSAN) - Program Support Services Branch (CFSAN)

• PST - porcine somatotropin

• PSUR - Periodic Safety Update Reports

• PT - part time

• PT - preferred term

• PTB (CBER) - Pharmacology and Toxicology Branch (CBER)

• PTC - Parklawn Training Center

• PTC - Points To Consider

• PTCC - Pharmacology and Toxicology Coordinating Committee (CDER)

• PTE - patent term extension

• PTEI - Pittsburgh Tissue Engineering Initiative

• PTFE - polytetrafluroethylene

• PTK - phototherapeutic keratectomy

• PTO - Patent and Trademark Office (U.S. Department of Commerce)

• PTR - platelet transfusion reaction

• PTS (CBER) - Product Testing Section (CBER)

• PTU - propylthiouracil

• PUD - peptic ulcer disease

• PUFI - packed under federal inspection

• PV - process validation

• PVC - polyvinyl chloride

• PVDB (CDRH) - Peripheral Vascular Devices Branch (CDRH)

• PWS - performance work statement

• Q & A - questions and answers

• Q1H - every 1 hour

• QA - quality assurance

• QAO - Quality Assurance Officer

• QAS (CBER) - Quality Assurance Staff (CBER)

• QAS (CDER) - Quality Assurance Staff (CDER)

• QAT (CBER) - Quality Assurance Team (CBER)

• QAU (CFSAN) - Quality Assurance Unit (CFSAN)

• QbD - Quality by Design

• QbR - Question-based Review

• QC - quality control

• QCP - quality control program

• QD - once daily

• QHS - at bedtime

• QID - four times a day

• QIS-P - Quality Information Summary Pharmaceuticals (Canada)

• QL - quality of life

• QMiS - Quality Management Information System

• QMS - Quality Management System

• QMS (CDER) - Quality Management Staff (CDER)

• QNS - quantity not sufficient

• QOD - every other day

• QoL - quality of life

• QOS - quality overall summary (of CTD)

• QP - qualified person (EU)

• QS - Quality System

• QSAR - Quantitative Structure Activity Relationship

• QSI - quality step increase

• QSIT - quality system inspection technique (CDRH)

• QSM - Quality System Manager

• QSR - quality system record

• QSR - quality system regulation

• QSR - quality system representative

• QTV - Qualified Through Verification (USDA)

• QU - quality unit

• QWL - quality of work life

• R & D - research and development

• R & E - Recall and Emergency (ORA)

• R & W - recreation and welfare

• R-CHOP - Drug combination that includes rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone

• RA - rheumatoid arthritis

• RAA - Research Across America

• RAC - raw agricultural commodity

• RAC - Recombinant DNA Advisory Committee (NIH)

• RAC - Regulatory Affairs Certification

• RAC - Reviewer Affairs Committee (CDER) disbanded 2000

• RACC - reference amount customarily consumed

• RACT (CFSAN) - Risk Assessment Coordination Team (CFSAN)

• RAD - rapid applications development

• RADAR - radio detecting and ranging

• RADAR - risk assessment of drugs - analysis and response

• RAE - remedial action exemption

• RAM - random access memory

• RAM - reporting and analysis module (EASE)

• RAMP - Remedial Action Management Program

• RAPS - Regulatory Affairs Professionals Society

• RBC - Red blood cells

• RCC - Research Coordinating Committee

• RCH - remove clinical hold

• RCHSA - Radiation Control for Health and Safety Act of 1968

• RCR - replication competent retrovirus

• RCR - Risk Control Review

• RCRIM - Regulated Clinical Research Information Management

• RCS - records control schedule

• RCS (CFSAN) - Regulations Coordination Staff (CFSAN)

• RCT - randomized clinical trial

• RCT (CFSAN) - Recall Team (CFSAN)

• RD - registration dossier

• RDA - recommended daily allowance

• RDB (CDRH) - Radiological Devices Branch (CDRH)

• RDBMS - Relational Database Management System

• RDE - remote data entry

• RDI - reference daily intake

• rDNA - recombinant deoxyribonucleic

• RDRC - Radioactive Drug Research Committee (CDER)

• RDT - rising dose tolerance

• RDTS - Reproductive and Developmental Toxicology Subcommittee (CDER)

• REDS-II - Retrovirus Epidemiology Donor Study

• REE - Research, Education and Economics (USDA)

• REG - drug registration number (ORA AofC code)

• reg neg - regulatory negotiation

• ReGo - Reinventing the United States Government

• REIS - Regional Economic Information System

• REMS - risk evaluation and mitigation strategy

• RES - Recall Enterprise System (ORA)

• RES - residence

• RES (OC) - Regulations Editorial Section (OC)

• RESNA - Rehabilitation Engineering & Assistive Technology Society of North America

• RFA - request for application

• RFC - request for contract

• RFCPCS (CFAN) - Retail Food and Cooperative Programs Coordination Staff (CFSAN)

• RFD - request for designation

• RFDD - Regional Food and Drug Director

• RFE - Regulatory Fish Encyclopedia

• RFI - request for information

• RFID - radio-frequency identification

• RFP - request for proposal

• RFPT (CFSAN) - Retail Food Protection Team (CFSAN)

• RFR - Reportable Food Registry

• RFS - Review Flow System

• RH - relative humidity

• RH - responsible head

• RIA - radioimmunoassay

• RIAS - regulatory impact analysis statement (Canada)

• RIBA™ - recombinant immunoblot assay (Chiron ®)

• RIC - Resident In Charge

• RICHS - Rural Information Center Health Service

• RIF - reduction-in-force

• RIHSC - Research Involving Human Subjects Committee (FDA)

• RIM - reference information model (HL7)

• RIMS - Regulatory Information Management Staff

• RIPA - radioimunoprecipitation assay

• RIS - Regulatory Information Specialist

• RIS (CBER) - Retroviral Immunology Section (CBER)

• RiskMAP - risk minimization action plan

• RIT - relocation income tax

• RKW1 - Rockwall Building I

• RKW2 - Rockwall Building II

• RL - regulatory letter (FDA post-audit letter)

• RLD - reference listed drug

• RM - raw material

• RMAB (CDRH) - Risk Management and Analysis Branch (CDRH)

• RMB (CBER) - Resource Management Branch (CBER)

• RMCC - Review Management Coordinating Committee (CBER)

• RMP - Regulatory Management Plan

• RMP - Risk Management Plan

• RMS - Reference Member State (Europe)

• RMS - regulatory management system

• RMS (CDER) - Review Management Staff (CDER)

• RMS-BLA - Regulatory Management System - Biologics License Application

• RMT (CFSAN) - Regulations Management Team (CFSAN)

• RNA - ribonucleic acid

• ROA - read only access

• ROC - receiver operating characteristic curve

• RODS - Real-Time Outbreak & Disease Surveillance System

• ROI - report of investigation

• ROI - return on investment

• ROM - Results Oriented Management

• RP - Resident Post

• RPB (CDRH) - Radiation Programs Branch (CDRH)

• RPM - Regulatory Procedures Manual (ORA)

• RPM - Regulatory Project Manager

• RPMB (CBER) - Regulatory Project Management Branch (CBER)

• RPMCC - Regulatory Project Management Coordinating Committee (CDER)

• RPMS (OC) - Regulations Policy and Management Staff (OC)

• RPO - Regional Personnel Office

• RPO - Regulatory Project Officer

• RPS - regulatory product submission

• RPS (CDER) - Regulatory Policy Staff (CDER)

• RPSGB - Royal Pharmaceutical Society of Great Britain

• RR - recall recommendation

• RR - relative risk

• RR - repeatedly reactive

• RRCC - Regional Response Coordination Center (FEMA)

• RRHR - regional radiological health representative

• RRS - Resource Reporting System (CBER)

• RRSS (CDER) - Regulatory Review Support Staff (CDER)

• RSB (CDER) - Recalls and Shortages Branch (CDER)

• RSB (CDER) - Review Support Branch (CDER)

• RSGEMS (CFSAN) - Regulations and Special Government Employees Management Staff (CFSAN)

• RSMB (CDRH) - Reporting Systems Monitoring Branch (CDRH)

• RSNA - Radiological Society of North America

• RSO - radiation safety officer

• RSOI - reception, staging, onward movement, and integration

• RSS - RDF (resource data framework) site summary

• RSS - really simple syndication

• RSS - rich site summary

• RSS (CDER) - Regulatory Support Staff (CDER)

• RSV - respiratory syncytial virus

• RSVIG - respiratory synctial virus immune globulin

• RSVIGIV - respiratory synctial virus immune globulin intravenous

• RSVP - Resource Reporting System Via Projects (CFSAN)

• RTA - refusal-to-accept

• RTE - ready-to-eat

• RTF - refusal to file

• RTF - rich text format

• RTL (NCTR) - Reproductive Toxicology Laboratory (NCTR)

• RTM - Recall Team member

• RTO - Regional Training Officer

• RTR - recall termination recommendation

• RU-486 - Roussel Uclaf (original designer) abortifacient drug (mifepristone)

• RUG - resource utilization group

• RUO - research use only

• RVIS - Residue Violation Information System

• Rx - prescription

• S & E - safety and effectiveness

• S/C - servings per container

• S/L - sick leave

• S/NDS - supplemental new drug submission (Canada)

• SA - sustained action medication

• SAB - Science Advisory Board

• SACD - Special Assistant to the Center Director

• SACS - Scientific Advisors and Consultants Staff (CBER)

• SACX - Secretary's Advisory Committee on Xenotransplantation (NIH)

• SAD - single ascending dose

• SADR - suspected adverse drug reaction

• SAE - serious adverse event

• SAER - Standard Adverse Event Report Review (CDRH)

• SAF - state access to FACTS

• SAI - single active ingredient

• SAL - sterility assurance level

• SAMHSA - Substance Abuse and Mental Heath Services Administration (DHHS)

• SAN-DO - San Francisco District Office

• SAP - Scientific Advisory Panel

• SAP - service access point

• SAP - Special Access Program

• SAP - Statistical Analysis Plan

• SAPB (CFSAN) - Shellfish and Aquaculture Policy Branch (CFSAN)

• SAR - search and rescue

• SARS - severe acute respiratory syndrome

• SAS - Symptom Assessment Scale

• SAT (CFSAN) - Statistical Applications Team (CFSAN)

• SB (ORA) - Systems Branch (ORA)

• SBA - Small Business Administration (U.S.)

• SBA - summary basis of approval

• SBIR - Small Business Innovation Research

• sBLA - supplemental Biologics License Application

• SBOA - Summary Basis of Approval

• SBREFA - Small Business Regulatory Enforcement Fairness Act

• SBRS - Senior Biomedical Research Service

• SC - study coordinator

• SC - subcutaneous

• SC (CDRH) - Staff College (CDRH)

• SC (CFSAN) - Staff College (CFSAN)

• SCAW - Scientists Center for Animal Welfare

• SCC - Sector Coordinating Council for Food and Agriculture

• SCD - service computation date

• SCGD - special controls guidance documents

• SCL - Symptom Checklist

• SCLIR - Secondary Calibration Laboratories for Ionizing Radiation

• SCOGS - Select Committee on GRAS Substances

• SCR - system change request

• SCRAG - Senior Civilian Representative of the Attorney Gemeral (Department of Homeland Security)

• SCRRB (ORA) - Scientific Compliance and Regulatory Review Branch (ORA)

• SCSB (CFSAN) - Scientific Computer Support Branch (CFSAN)

• SCT - Society for Clinical Trials

• SCVIR - Society for Cardiovascular and Interventional Radiologists (now SIR)

• SD - Scientific Director

• SD - standard deviation

• SDAB (CDER) - Surveillance and Data Analysis Branch (CDER)

• SDM - Submission Data Model (CDISC)

• SDM - system development methodology

• SDN - Screening Deficiency Notice (Canada)

• SDO - Standards Development Organization

• SDS - Submission Data Standards (CDISC)

• SDS-PAGE - sodium dodecyl sulfate polyacrylamide gel electrophoresis

• SDTM - Study Data Tabulation Model (CDISC)

• SDWA - Safe Drinking Water Act

• SDWIS - Safe Drinking Water Information System

• SE - Salmonella Enteriditis

• SE - standard error

• SE - substantially equivalent

• SEC - Securities and Exchange Commission (U.S.)

• SEDS - Shared Establishment Data Service (FHA)

• SEER - Surveillance, Epidemiology, and End Results (Registry of NCI)

• SEIU - Service Employees International Union

• SEND - Standards for Exchange of Nonclinical Data (Consortium)

• SES - Senior Executive Service

• SF - safety factor

• SF - Standard Form

• SFB - spore-forming bacteria

• SFIT - Safety First Implementation Team

• SFLEO - senior federal law enforcement official

• SFSC - Safety First Steering Committee

• SG - study group

• SGE - Special Government Employee

• SGEMT (CFSAN) - Special Government Employees Management Team (CFSAN)

• SGI - Summer Genetics Institute

• SGLT2 - sodium-glucose co-transporter 2

• SGML - standard generalized markup language

• SGO - Surgeon General's Office

• SHE - safety, health and environment

• SIA - strip immunoblot assay

• SIB (CDRH) - Special Investigations Branch (CDRH)

• SID - schedule identifier number (ORA AofC code)

• SID - Source to Image Distance

• SIDS - sudden infant death syndrome

• SIF - seafood HACCP importer form (ORA AofC code)

• SIG - Strategic Implementation Group

• SIMCEN - National Exercise Simulation Center

• SIMT - Scientific, Internet/Intranet and Middle Tier (CFSAN)

• SIP - sterilization in place

• SIP - Summer Internship Program in Biomedical Research

• SIR - Society of Interventional Radiology (formerly SCVIR)

• SIREN - Scientific Information Retrieval and Exchange Network (CFSAN)

• SIS - Streamlined Inspection System (USDA)

• SISTIR - Strategic Information Systems Technical Integration Resources

• SITP (OC) - Strategic IT Programs (OC)

• SL - signature (address) line

• SLEP - Shelf Life Extension Program

• SLIP - serial line internet protocol/point-to-point protocol

• SLK - Statens Legemiddel Kontroll (Norwegian Medicines Control Authorities)

• SLO - state liaison officer

• SLR - Supplement Labeling Revision

• SM - starting material

• SMART - Submission Management and Review Tracking

• SMB (OC) - Space Management Branch (OC)

• SMCC - Standards Management Coordinating Committee (CBER)

• SMDA - Safe Medical Devices Act of 1990

• SME - significant medical event

• SME - subject matter expert

• SMF - site master file

• SMG - Staff Manual Guide

• SMO - site management organization

• SMPS (CDRH) - Standards Management Program Staff (CDRH)

• SMS - Standards Management Staff (CDRH)

• SMS (CFSAN) - Safety Management Staff (CFSAN)

• SMSB (CFSAN) - Spectroscopy and Mass Spectrometry Branch (CFSAN)

• SMT (CDER) - Senior Management Team (CDER)

• SMT (CFSAN) - Statistical Methodology Team (CFSAN)

• SMTP - simple mail transfer protocol

• SN/AEMS - Special Nutritional Adverse Events Monitoring System

• sNDA - supplemental new drug application

• SNIP - Syndicat National de l'Industrie Pharmaceutique

• SNL - Sandia National Laboratories

• SNOMED-RT - Systematized Nomenclature of Medicine Reference Terminology

• SNRI - serotonin-norepinephrine reuptake inhibitor

• SNS - strategic national stockpile (CDC)

• SOAB (OC) - Systems and Office Automation Branch (OC)

• SOC - System Organ Class

• SOCRA - Society of Clinical Research Associates

• SOM - sensitivity of method

• SOP - standard operating procedure

• SoPA - submission of portion of application

• SOPP - Standard Operating Procedures and Policies

• SORN - System of Records Notice

• SOW - statement of work

• SPA - Special Protocol Assessment

• SPAC - State Pharmaceutical Administration of China

• SPC - Summary of Product Characteristics (EMEA)

• SPCS (CDER) - Safety Policy and Communications Staff (CDER)

• SPECT - single-photon emission computed tomography

• SPF - sun protection factor

• SPIE - International Society for Optical Engineering

• SPL - structured product labeling

• SPLAT - Structured Product Labeling Advisory Team

• SPLIEP - Structured Product Labeling Interagency Executive Panel

• SPOTS - Special Products On-Line Tracking System (CDER)

• spp - species

• SPPA - Strategic Partnership Program Agroterrorism Initiative

• SPR - system problem report

• SPRC - Seafood Products Research Center (CFSAN)

• SPS - sanitary and phytosanitary

• SPS (CFSAN) - Science and Policy Staff (CFSAN)

• SPTPB (CFSAN) - Seafood Processing and Technology Policy Branch (CFSAN)

• SQ - subcutaneous

• SQA - Society of Quality Assurance

• SQL - structured query language

• SR - significant risk

• SR - sustained release medication

• SRAS - Secure Remote Access Service

• SRCS - Division of Surveillance, Research, and Communication Support (CDER)

• SRD - significant risk device

• SRD - single rising dose

• SRD - swine respiratory disease

• SRD - system requirements document

• SRMs - specified risk materials

• SRS - spontaneous reporting system

• SRS - Substance Registration System

• SRS - System Requirements Specification

• SRS (CDER) - Science and Research Staff (CDER)

• SS - serving size

• SSA - sector-specific agencies

• SSA - Social Security Administration (U.S.)

• SSAST (CFSAN) - Senior Science Advisor's Staff (CFSAN)

• SSB (CDRH) - Systems Support Branch (CDRH)

• SSC - Special Search Category

• SSC - Systems Steering Committee (CBER)

• SSCT - Swedish Society for Clinical Trials

• SSE - Summary of Safety and Effectiveness

• SSED - summary of safety and effectiveness data

• SSM - skin surface microscopy

• SSN - Social Security number

• SSO - Single Sign-On

• SSOP - sanitation standard operating procedures

• SSP - sector-specific plan

• SSRCR - Suggested State Regulations for Control of Radiation

• SSRI - selective serotonin reuptake inhibitor

• SSSI - skin and skin structure infection

• STA - special temporary authority

• STAI - Strait Anxiety Inventory

• STAMP - Systematic Technology Assessment of Medical Products (CDRH)

• STARS - Submission Tracking and Reporting System

• STB (ORA) - State Training Branch (ORA)

• STCD - sterile connecting device

• STD - sexually transmitted disease

• STED - Summary Technical Document

• STEPS - System for Thalidomide Education and Prescribing Safety

• STN - submission tracking number

• STOP - Safe Tables Our Priority

• STS (CBER) - Standards and Testing Staff (CBER)

• STT - short term tests

• Subpart H - That subpart of 21 CFR Part 314 pertaining to accelerated approval of drugs

• SUD - single-use device

• SUD - sudden unexpected death

• SUDs - Single Use Devices

• SUPAC - scale up and post-approval changes

• SUPAC-IR - scale-up and postapproval changes--immediate release

• SUPAC-MR - scale-up and postapproval changes--modified release

• SUPAC-SS - scale-up and postapproval changes--nonsterile solid

• SUSAR - suspected unexpected serious adverse reaction

• Sv - sievert

• SVP - small-volume parenteral

• SWAT - Special Weapons and Tactics

• SWDB (CDRH) - Software and Web Development Staff (CDRH)

• SX - symptoms

• T&A - time and attendance

• T/PT - traceability/product tracing

• TA - Technology Administration (U.S.)

• TA - temporary abeyance

• TA - tentative approval

• ta - travel authorization

• TAA - transfusion-associated AIDS

• TAB (OC) - Travel Audit Branch (OC)

• TAB (CDRH) - Technical Assistance Branch (CDRH)

• TAH - transfusion-associated hepatitis

• TAS (NCTR) - Technology Advancement Staff (NCTR)

• TAV - travel authorizations and vouchers

• TAVC - total aerobic viable count

• TB - tuberculosis

• TBD - to be determined

• TBLS - Team Biologics Liaison Staff (CBER)

• TBP - therapeutic biologic product

• TBSB (CBER) - Therapeutics and Blood Safety Branch (CBER)

• TBT - technical barriers to trade

• TCM - Traditional Chinese Medicine

• TCP/IP - transmission control protocol/internet protocol

• TCS - temporary change of station

• TD - target date

• TDD - telecommunications device for the deaf

• TDDB (CDRH) - Television Design and Development Branch (CDRH)

• TDDS - transdermal drug delivery system

• TDI - tolerable daily intake

• TdP - Torsades de Pointes

• TDS - Total Diet Study (CFSAN)

• TDY - temporary duty

• TE - therapeutic equivalence

• TEAE - Treatment-Emergent Adverse Event

• TEB (CBER) - Therapeutics Evaluation Branch (CBER)

• TEE - Transesophageal Echocardiogram

• TELECON - telephone conferencing

• TEP - therapeutic exchange plasmapheresis

• TEPRSSC - Technical Electronic Product Radiation Safety Standards Committee

• TERMIS - Tissue Engineering and Regenerative Medicine International Society

• TESS - Toxic Exposure Surveillance System

• TESS - treatment emergent signs and symptoms

• TFM - tentative final monograph

• TFRB (CDER) - Therapeutic Facilities Review Branch (CDER)

• TGA - Therapeutic Goods Administration (Australia)

• TI - tolerable intake

• TIACC - Therapeutic Inequivalence Action Coordinating Committee

• TID - three times a day

• TIFF - tagged image file format

• TIND - treatment investigational new drug

• TIRF - transmucosal immediate-release fentanyl

• TK - toxicokinetics

• TLC - thin layer chromatography

• Tmax - time to maximum plasma concentration

• TMJ - temporomandibular joint

• TMO - trial management organization

• TNTC - too numerous to count

• TO - table of oganization

• TO - transportation officer

• TOA - total obligation authority

• TOC - total organic carbon

• TOI - trial outcome index

• TOL - total organic carbon

• TOPOFF - Top Officials terrorism exercise

• TOPRA - The Organisation for Professionals in Regulatory Affairs

• TOR - threshold of regulation

• TPCC - Therapeutic Products Classification Committee (Canada)

• TPD - Therapeutic Products Directorate (Canada)

• TPDS - Training and Professional Development Staff (CBER)

• TPLC - Total Product Life Cycle

• TPN - total parenteral nutrition

• TPP - Target Product Profile

• TPSAC - Tobacco Products Scientific Advisory Committee

• TQM - Total Quality Management

• TRAC - Tolerance Reassessment Advisory Committee (EPA)

• TRALI - transfusion-related acute lung injury

• Trans Net - internet-based blood shortage reporting program (FDA)

• TRB - Technical Review Board

• TRI - Toxics Release Inventory (EPA)

• TRIMS - Tissue Residue Information System

• TRO - temporary restraining order

• TRx - total (number of) prescriptions

• TSA - Transportation Security Administration (Department of Homeland Security)

• TSCA - Toxic Substances Control Act of 1976

• TSCSB (CFSAN) - Telecommunications and Scientific Computer Support Branch (CFSAN)

• TSD (OC) - Travel Services Division (OC)

• TSE - transmissible spongiform encephalopathies

• TSEAC - Transmissible Spongiform Encephalopathies Advisory Committee (CBER)

• TSH - thyroid stimulating hormone

• TSI - tracked safety issue

• TSOPs - temperature standard operating procedures

• TSP - Thrift Savings Plan

• TSS - Transfusion Safety Study

• TSSRC - Toxicology Study Selection and Review Committee (FDA-NIEHS)

• TSSS (CDER) - Technology Support Services Staff (CDER)

• TTTC - Take Time To Care program

• TTY - teletypewriters or text telephones

• Turbo EIR - Turbo Establishment Inspection Report (ORA)

• TV - travel voucher

• TVA - Tennessee Valley Authority

• TVBB (CBER) - Tumor Vaccines and Biotechnology Branch (CBER)

• TVC - total viable count

• TWG - technical working group

• U - units

• UA - urinalysis

• UADE - unanticipated adverse device event

• UCB - umbilical cord blood

• UCBU - umbilical cord blood unit

• UCUM - Unified Codes for Units of Measure (Regenstrief Institute)

• UDHQ - Uniform Donor Health Questionnaire

• UDI - unique device identification

• UFC - unacceptable to foreign country (ORA AofC code)

• UFMS - Unified Financial Management System

• UIN - unique identification number

• UK - United Kingdom

• UKCCR - United Kingdom Coordinating Committee on Cancer Research

• UL - Underwriters Laboratories

• ULDB (CDRH) - Urology and Lithotripsy Devices Branch (CDRH)

• ULN - upper limit of normal

• ULPA - ultra-low penetration air

• UMCP - University of Maryland-College Park

• UMDNS - Universal Medical Device Nomenclature System

• UMLS - Unified Medical Language System (NLM)

• UMS - Unified Modeling Language (Object Management Group)

• UN - unacceptable

• UN - United Nations

• UNAIDS - Joint United Nations Program on HIV/AIDS

• UNESCO - United Nations Educational, Scientific and Cultural Organization

• UNICEF - United Nations Children's Fund

• UNII - Unique Ingredient Identifier

• UNOS - United Network for Organ Sharing

• URAA - Uruguay Round Agreements Act of 1994

• URL - uniform resource locator

• URS - user requirement specification

• US & R - urban search and rescue

• USA - United States Army

• USACE - United States Army Corps of Engineers

• USAHA - United States Animal Health Association

• USAID - United States Agency for International Development

• USAMRIID - U.S. Army Medical Research Institute for Infectious Diseases

• USAN - United States Adopted Name

• USBR - Bureau of Reclamation (U.S. Department of the Interior)

• USC - United States Code

• USCA - U.S. Code Annotated

• USCG - United States Coast Guard

• USCS - United States Customs Service (U.S. Department of Homeland Security)

• USDA - Department of Agriculture (U.S.)

• USFDA - United States Food and Drug Administration

• USFS - United States Forest Service (U.S. Department of Agriculture)

• USGS - United States Geological Survey

• USHIK - United States Health Information Knowledge Base

• USIA - United States Information Agency

• USITC - United States International Trade Commission

• USJFCOM - United States Joint Forces Command

• USMS - United States Marshals Service

• USOPM - United States Office of Personnel Management

• USP - U.S. Pharmacopeia

• USP-DI - United States Pharmacopeia-Drug Information

• USP-NF - United States Pharmacopeia-National Formulary

• USPC - U.S. Pharmacopeial Convention

• USPEA - U.S. Poultry and Egg Association

• USPS - United States Postal Service

• USPTO - United States Patent and Trademark Office (U.S. Department of Commerce)

• USTFA - U.S. Trout Farmers Association

• USTR - United States Trade Representative

• USUHS - Uniformed Services University of the Health Sciences

• UTI - urinary tract infection

• V/V - verification/validation

• VA - Department of Veterans Affairs (U.S.)

• VADM - Vice Admiral

• VAERS - Vaccine Adverse Event Reporting System

• VAI - voluntary action indicated

• VAP - ventilator-associated pneumonia

• VAS - visual analog scale

• VATS - Vacancy Announcement Tracking System (PHS)

• VATS - Viral Activation Transfusion Study

• VAX - virtual address eXtension

• VBPF - vegetative bacteria, protozoa and viruses

• VCH - travel voucher claim

• vCJD - variant Creutzfeldt Jakob disease

• VCOOL - voluntary country-of-origin labeling

• VCPR - veterinarian/client/patient relationship

• VCRP - Voluntary Cosmetic Registration Program (CFSAN)

• VCTB (CBER) - Vaccine Clinical Trials Branch (CBER)

• VDB (CDRH) - Virology Devices Branch (CDRH)

• VE - vaccine efficacy

• VEB (CBER) - Vaccine Evaluation Branch (CBER)

• VEDB (CDRH) - Vitreal and Extraocular Devices Branch (CDRH)

• VEE - Venezuelan equine encephalomyelitis

• VEGF - vascular endothelial growth factor

• Vet-LIRN - Veterinary Laboratory Investigation and Response Network (formerly Vet-LRN: Veterinary Laboratory Response Network)

• Vet-LRN - Veterinary Laboratory Response Network

• VetTrade - Veterinarian Trading Post (website)

• VFD - veterinary feed directive

• VHA - Veterans Health Administration

• VHSP - Viral Hepatitis Surveillance Program (CDC)

• VICH - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products

• VICH - Veterinary International Committee on Harmonisation

• VIG - vaccinia immune globulin

• VIPPS - Verified Internet Pharmacy Practice Sites

• VISB (OC) - Visual Information Services Branch (OC)

• VLTP - Voluntary Leave Transfer Program

• VMAC - Veterinary Medicine Advisory Committee (CVM)

• VMB (CFSAN) - Virulence Mechanisms Branch (CFSAN)

• VMD - Veterinariae Medicinae Doctoris

• VMF - veterinary master file

• VMO - veterinary medical officer

• VMP - validation master plan

• VMS - virtual memory system operating system

• VOAD - Volunteer Organizations Active in a Disaster

• VoIP - Voice over Internet Protocol

• VPN - Virtual Private Network

• VPS - Veterinary Product Safety

• VRBPAC - Vaccines and Related Biological Products Advisory Committee (CBER)

• VS - visiting scientist

• VS (CBER) - Validation Staff (CBER)

• VSB (CBER) - Vaccine Safety Branch (CBER)

• VSD - Vaccine Safety Datalink project (CDC)

• VSOF - visual status of funds

• VSS (NCTR) - Veterinary Services Staff (NCTR)

• VVB (CBER) - Viral Vaccines Branch (CBER)

• W3C - World Wide Web Consortium

• WAE - when-actually-employed

• WAG - widely attended gathering

• WAN - wide area network

• WAT (CFSAN) - Worklife Analysis Team (CFSAN)

• WB - Western Blot

• WBC - white blood cell

• WBS - work breakdown structure

• WEAC - Winchester Engineering and Analytical Center

• WebSDM - Web-based Submission Data Manager

• WEDA - Workforce Equity and Diversity Action

• WEDI - Workgroup for Electronic Data Interchange

• WFH - World Federation of Hemophilia

• WFI - water for injection

• WG - wage grade

• WHO - World Health Organisation

• WHO-ART - World Health Organisation Adverse Reaction Terminology

• WIB - Western immunoblot

• WIC - Special Supplemental Nutrition Program for Women, Infants, and Children (USDA)

• WIGI - within-grade increase

• WISQARS - Web-based Injury Statistics Query and Reporting System (CDC)

• WIT - Workflow Improvement Team

• WITS - Washington Interagency Telecommunications System

• WL - warning letter

• WLF - Washington Legal Foundation

• WMS (OC) - Website Management Staff (OC)

• WNET - Women's Network for Entrepreneurial Training (SBA)

• WNME - West Nile meningoencephalitis

• WNV - West Nile virus

• WO - White Oak Campus - FDA

• WO (NCTR) - Washington Office (NCTR)

• WOC I - Woodmont Office Complex I (north)

• WOC II - Woodmont Office Complex II (south)

• WONF - with other natural flavors

• WPADP - Working Party on Automation and Data Processing (International Society of Blood Transfusion)

• WPC - WordPerfect character mapping file

• WPS (OC) - Workforce Programs Staff (OC)

• WRAIR - Walter Reed Army Institute of Research

• WRAMC - Walter Reed Army Medical Center

• WSHSC - water soluble, heat stable chemicals

• WSL (CFSAN) - Washington Seafood Laboratory (CFSAN)

• WTA - withholding tax allowance

• WWW - world wide web

• WYSIWYG - what you see is what you get

• X-SCID - X-linked severe combined immunodeficiency disorder

• xBML - Extended Business Modeling Language

• XDR-TB - extensively drug-resistant tuberculosis

• XML - extensible markup language

• Y2K - year 2000

• YTD - year to date

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