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>> Fda Abbreviations
Look through 3648 acronyms and abbreviations related to Fda:
CPR
— Cardiopulmonary Resuscitation
PRIM & R
— Public Responsibility in Medicine and Research
LAN
— Local Area Network
CF
— Cystic Fibrosis
N/A
— Not Applicable
L & D
— labor and delivery
PREA
— Pediatric Research Equity Act of 2003
PR (CBER)
— Product Review Branch (CBER)
PRB (CFSAN)
— Pathology Branch (CFSAN)
PRB (CBER)
— Product Release Branch (CBER)
PPWMB (ORA)
— Program Planning and Workforce Management Branch (ORA)
PQLS (CBER)
— Product Quality Laboratory Staff (CBER)
S & E
— safety and effectiveness
PPS (CBER)
— Policy and Publications Staff (CBER)
PRA
— Paperwork Reduction Act of 1995
POS (CDRH)
— Program Operations Staff (CDRH)
PPB (CFSAN)
— Plant Products Branch (CFSAN)
I & D
— incision and drainage
POS (CBER)
— Program Operation Staff (CBER)
PPSR
— Proposal for Pediatric Studies Request
PO
— Per Os (by mouth)
PQLS
— Product Quality Laboratory Staff
COPD
— Chronic Obstructive Pulmonary Disease
PPTA
— Plasma Protein Therapeutics Association
POB (CBER)
— Program Operations Branch (CBER)
YTD
— Year To Date
PPC
— Production and Process Controls
IMP
— Investigational Medicinal Product
PPWMB
— Program Planning and Workforce Management Branch
PPS
— Policy and Publications Staff
POWER
— Petition Optical Workflow, Exchange, and Retrieval
R & E
— Recall and Emergency (ORA)
Q1H
— Every 1 Hour
DM
— Diabetes mellitus
I & O
— intake and output
XML
— Extensible Markup Language
ASAP
— As Soon As Possible (pronounced AY-sap)
CHF
— Congestive Heart Failure
Q & A
— questions and answers
OEM
— Original Equipment Manufacturer (usually in reference to car parts)
ECG
— Electrocardiogram
AF
— Atrial Fibrillation
CABG
— Coronary Artery Bypass Graft
ANSI
— American National Standards Institute, Inc.
FLSA
— Fair Labor Standards Act
R & W
— recreation and welfare
DAT
— Diet As Tolerated
FTP
— File Transfer Protocol
PNS (CDRH)
— Premarket Notification Section (CDRH)
RFID
— Radio Frequency Identification
PMS (OC)
— Print Media Staff (OC)
IT
— Information Technology
LASER
— Light Amplification By Stimulated Emission Of Radiation (cf. Maser)
PNC (ORA)
— Prior Notice Center (ORA)
PMSB (CDER)
— Program Management Services Branch (Center for Drug Evaluation and Research)
R & D
— research and development
M&IE
— Meals and Incidental Expenses
PMSB (CBER)
— Program Management Services Branch (Center for Biologics Evaluation and Research)
CSR
— Customer Service Representative
PNS
— Premarket Notification Section
UK
— United Kingdom of Great Britain and Northern Ireland
EPA
— Environmental Protection Agency (US)
PMS (CDRH)
— Program Management Staff (CDRH)
POC
— Point Of Contact
HIPAA
— Health Insurance Portability and Accountability Act of 1996
PMSB
— Pharmaceutical and Medical Safety Bureau (Japan)
COB
— close of business (End of duty day)
CPP
— Certificate of Pharmaceutical Product
PETG
— Polyethylene Terephthalate Glycol
PMSC
— Pre-Market Surveillance and Compliance
ATM
— Automatic Teller Machine
CVA
— Cerebrovascular Accident
FIFO
— First In, First Out
PDF
— Portable Document Format (created by Adobe Acrobat)
UNICEF
— United Nations International Children's Emergency Fund
PIB (CBER)
— Program Inspection Branch (CBER)
PGB (CFSAN)
— Policy Guidance Branch (CFSAN)
PMHS (CDER)
— Pediatric and Maternal Health Staff (CDER)
CT
— Computed Tomography
PIC/S
— Pharmaceutical Inspection Co-operation Scheme
UNESCO
— United Nations Educational, Scientific and Cultural Organization
OCC (OC)
— Office of the Chief Counsel (OC)
P & PC
— production and process controls
PNIG
— Patient Narrative Information Guide
QC
— Quality Control
GUI
— Graphical User Interface (goo-ey)
ANOVA
— Analysis of Variance (statistics)
BA/BE
— Bio-Availability/Bio-Equivalence
SSN
— Social Security Number
R&D
— Research & Development
MOU
— Memorandum of Understanding (an MOU between Food & Drug Administratin and a regulatory agency in another country allows mutual recognition of inspections)
PGB
— Policy Guidance Branch
BPM
— Beats Per Minute
FAQ
— Frequently Asked Questions (sometimes Pronounced Fak)
PMC
— Post-Marketing Commitment
PMN#
— Pre-Market Notification number of a device
PHSA
— Public Health Service Act of 1944
PLI
— Pre-License Inspection
PMA#
— Pre-Market Approval device number
RFP
— Request For Proposal
ISP
— Internet Service Provider
PIP
— Plant-Incorporated Protectant
TQM
— Total Quality Management
PLF
— Product Licensing Framework (Canada)
RSV
— Respiratory Syncytial Virus
FEMA
— Federal Emergency Management Agency
CY
— Calendar Year
CBC
— Complete Blood Count
EDI
— Electronic Data Interchange
PMCC
— Project Management Coordinating Committee
PIB
— Program Inspection Branch
PMHS
— Pediatric and Maternal Health Staff
MRB
— Material Review Board
SD
— Standard Deviation
E-CRF
— electronic case report form
PLAS
— Prior Label Approval System
PHN
— Population, Health, and Nutrition Center
CEO
— Chief Executive Officer
ASTM
— American Society for Testing and Materials (Philadelphia, Pennsylvania)
DAARP (CDER)
— Division of Anesthesia, Analgesia, and Rheumatology Products (CDER)
G-MED (LNE)
— Groupfor Medical Device Assessment (Laboratoire National de Metrologie et d'Essias)
PKLN
— ParkLawn Building
MRI
— Magnetic Resonance Imaging
PSUR
— Periodic Safety Update Report
A-VO2
— arteriovenous oxygen
PIFSI
— Produce and Imported Foods Safety Initiative
B&F (CVM)
— Budget and Finance Team (CVM)
TBD
— To Be Determined
WBS
— Work Breakdown Structure
ACTH
— Adrenocorticotropic Hormone
XDR-TB
— Extensively Drug-Resistant Tuberculosis
SME
— Subject Matter Expert
MSDS
— Material Safety Data Sheets
VPN
— Virtual Private Network (ATM)
IV
— Intravenous
SACX
— Secretary's Advisory Committee on Xenotransplantation
OBP (CDER)
— Office of Biotechnology Products (CDER)
FX
— Fracture
HTTP
— Hypertext Transfer Protocol
SMTP
— Simple Mail Transfer Protocol
OTC
— Over The Counter (medications not requiring a prescription)
FY
— Fiscal Year
ASME
— American Society of Mechanical Engineers
NCR
— Non-Conformance Report
EEO
— Equal Employment Opportunity
ADH
— Antidiuretic Hormone
IPO
— Initial Public Offering
ARPA
— Advanced Research Projects Agency (made early internet)
DOD
— United States Department of Defense
QA
— Center for Quality Assurance in International Education
DAAP (CDER)
— Division of Anesthesia and Analgesia Products (CDER)
GI
— Gastrointestinal
WWW
— World Wide Web
FYI
— For Your Information
SOW
— Statement Of Work
QIS-P
— Quality Information Summary - Pharmaceuticals
D0AF (CDRH)
— Division of Planning, Analysis and Finance (CDRH)
CV
— Curriculum Vitae
C-CDA
— Consolidated - Clinical Document Architecture
USDA
— United States Department of Agriculture
M2 EWG
— ICH M2 Expert Working Group
CPI
— Consumer Price Index
DNR
— Do Not Resuscitate
DIC
— disseminated intravascular coagulation
E-ARCH
— Extended Adult Residential Care Home
P&PC
— Production and Process Control
ADP
— Automated Data Processing
UCBU
— Umbilical Cord Blood Unit
POS
— Point Of Sale.Retail term, being the physical point at which products are displayed on shelves or paid for at the checkout, as in the EPOS acronym.
TAB (OC)
— Travel Audit Branch (OC)
DVM
— Doctor of Veterinary Medicine
RAM
— random-access memory
RACT (CFSAN)
— Risk Assessment Coordination Team (CFSAN)
WAT (CFSAN)
— Worklife Analysis Team (CFSAN)
COBRA
— Consolidated Omnibus Budget Reconciliation Act of 1985
DX
— Diagnosis
CAB (OC)
— Computer Applications Branch (OC)
QAS (CBER)
— Quality Assurance Staff (CBER)
ANZFA
— Australia New Zealand Food Authority (now Food Standards Australia New Zealand)
RFI
— Request For Information. Sales department shorthand. Special priority when use in conjunction with RFN (see below).
AABB
— American Association of Blood Banks
FBI
— Federal Bureau of Investigation
NGO
— Non-governmental organization. (Red Cross/Crescent, Doctors without Borders, etc.)
NSN
— National Stock Number
CVP
— Central Venous Pressure
DAC (CFSAN)
— Division of of Analytical Chemistry (CFSAN)
CV
— Cardiovascular
FACS (CFSAN)
— Food Advisory Committee Staff (CFSAN)
DADS (CDER)
— Division of Applications Development and Services (CDER)
KG
— Kilogram
CNS
— Central Nervous System
ISDN
— Integrated Services Digital Network
CBO
— Congressional Budget Office
AMA
— American Medical Association
ᄃ
— Section; shorthand symbol used to designate a section in a legal document
℮
— estimated
BARS (CDER)
— Business Analysis and Reporting Staff (CDER)
WAN
— Wide Area Network
IAMFES
— International Association of Milk, Food and Environmental Sanitarians
M4 EWG
— ICH M4 Expert Working Group
NCCLS
— National Committee for Clinical Laboratory Standards
DBA
— Doing Business As
DA (OC)
— Division of Accounting (OC)
BBS
— Bulletin Board System
FARMINDU STRIA
— Association of Italian Pharmaceutical Manufacturers
DSS
— Decision Support System
DHR
— Device History Record
DAS (CFSAN)
— Division of Administrative Services Management (CFSAN)
HAB (CFSAN)
— Hazard Assessment Branch (CFSAN)
IAB (ORA)
— Infrastructure Applications Branch (ORA)
DAFM (CVM)
— Division of Animal and Food Microbiology (CVM)
IAB (CDRH)
— Information and Analysis Branch (CDRH)
OCAC (CFSAN)
— Office of Cosmetics and Colors (CFSAN)
QAT (CBER)
— Quality Assurance Team (CBER)
LOV
— List Of Values
OBRR (CBER)
— Office of Blood Research and Review (CBER)
CIO
— Chief Information Officer
VBPV
— Vegetative Bacteria, Protozoa, and Viruses
MACS (CBER)
— Manufacturers Assistance and Communications Staff (CBER)
LANGUAL
— Langua Alimentaria (Language of Foods)
ᄃᄃ
— Sections; shorthand symbol used to designate sections in a legal document
EAB (CFSAN)
— Exposure Assessment Branch (CFSAN)
DAEA II
— Division of Adverse Event Analysis 2
OCD (CDRH)
— Office of the Center Director (CDRH)
FACTS@FDA
— system for electronically communicating approved drug labeling and for disseminating prescribing information
DARRTS
— Document Archiving, Reporting, and Regulatory Tracking System
IAS (OC)
— International Agreements Staff (OC)
CMC
— Chemical Manufacturing Control
RSS (CDER)
— Regulatory Support Staff (CDER)
QAU (CFSAN)
— Quality Assurance Unit (CFSAN)
OCD (CVM)
— Office of the Center Director (CVM)
J/D
— Judgment for the Defendant
TAB (CDRH)
— Technical Assistance Branch (CDRH)
OC (CDRH)
— Office of Compliance (CDRH)
AARP
— American Association of Retired Persons
OAGS (OC)
— Officeof Acquisitions and Grants Services (OC)
DHCP
— Dynamic Host Configuration Protocol
DAS (NCTR)
— Division of Administrative Services (NCTR)
OC (CFSAN)
— Office of Compliance (CFSAN)
EAS (CDER)
— Enterprise Architecture Staff (CDER)
T/PT
— Traceability/Product Tracing
PC
— Personal computer (host)
CFR
— Code of Federal Regulations
OCBQ (CBER)
— Office of Compliance and Biologics Quality (CBER)
DAE (OC)
— Division of Applied Engineering (OC)
FAEMS
— Foods Adverse Event Monitoring System
DAGID (CDRH)
— Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (CDRH)
PAIS (ORA)
— Public Affairs and Information Staff (ORA)
OC (CDER)
— Office of Compliance (CDER)
OB (CDER)
— Office of Biostatistics (CDER)
RRSS (CDER)
— Regulatory Review Support Staff (CDER)
OBQI/M
— Outcome-Based Quality Improvement/Monitoring
FR
— Federal Register
HMO
— Health Maintenance Organization
DAF (CVM)
— Division of Animal Feeds (CVM)
S/NDS
— Supplemental / New Drug Submission
OAP (CDER)
— Office of Antimicrobial Products (CDER)
MAB (CFSAN)
— Methods Application Branch (CFSAN)
ASD
— Atrial Septal Defect
DAIOP (CDER)
— Division of Anti-infective and Ophthalmology Products (CDER)
NAET (CFSAN)
— Nutrition Assessment and Evaluation Team (CFSAN)
BP
— Blood Pressure
WYSIWYG
— What You See Is What You Get (pronounced Wizzy-wig. See Entry For Derived Acronyms)
OCD (CFSAN)
— Office of the Center Director (CFSAN)
OBFP (OC)
— Office of Budget Formulation and Presentation (OC)
RDBMS
— Relational Database Management System
OARSA (CFSAN)
— Office of Applied Research and Safety Assessment (CFSAN)
DAR (CVM)
— Division of Animal Research (CVM)
SQL
— Structured Query Language
IUPAC
— International Union of Pure and Applied Chemistry
MAB (CDER)
— Management Analysis Branch (CDER)
ADA
— Americans With Disabilities Act Of 1990 (Text Of ADA Legislation)
OBPS (CDER)
— Office of Business Process Support (CDER)
DAPR (CDER)
— Division of Applied Pharmacology Research (CDER)
LOA
— Letter Of Agreement
MACMIS
— Marketing, Advertising and Communication Management Information System
EANDA
— Electronic Abbreviated New Drug Application
AAR
— After Action Review
CONUS
— Continental United States (48 Contiguous States and DC)
PAB (CFSAN)
— Product Adulteration Branch (CFSAN)
OBES (OC)
— Office of Business Enterprise Solutions (OC)
OMB
— Office of Management and Budget (U.S.)
ICAO
— International Civil Aviation Organization
AS
— Aortic Stenosis
LOD
— Limit Of Detection
EEOC
— Equal Employment Opportunity Commission
SAR
— Search And Rescue
EO
— Executive Order
J-ART
— Japanese Adverse Reaction Terminology
AHU
— Air Handling Unit
NHLBI
— National Heart, Lung, and Blood Institute
CGI
— Common Gateway Interface
BUN
— Blood Urea Nitrogen
CACBERS
— Committee for the Advancement of CBER Science
FAPMC
— Food Animal Production Medicine Consortium
º
— section û shorthand symbol used to designate a section in a legal document; as in º201(m) of the FD&
DL
— Deciliter
TB
— Tuberculosis
DAILYMED
— NLM-based database of information on marketed drugs including FDA-approved labels.
IDP
— Individual Development Plan
NIST
— National Institute of Standards and Technology
QMS
— Quality Management System
CFO
— Communication Filing Officer
BX
— Biopsy
MTD
— Maximum Tolerated Dose (that does not produce unacceptable toxicity)
CAD
— Coronary Artery Disease
MCO
— Managed Care Organization
CC
— Chief Complaint
EEC
— European Economic Community (predecessor of the European Union|EU)
ARC
— American Red Cross
RA
— Rheumatoid Arthritis
FOIA
— Freedom of Information Act
CRS
— Congressional Research Service
EFT
— Electronic Funds Transfer
ANA
— Antinuclear Antibody
ECL
— Electrochemiluminescence
IATA
— International Air Transport Association
SES
— Senior Executive Service
DOJ
— Department of Justice (US)
DJD
— Degenerative Joint Disease
CSF
— Cerebrospinal Fluid
FAO
— Food and Agriculture Organization of the United Nations
DBMS
— Database Management System
HGB
— Hemoglobin
GSA
— U.S. General Services Administration
MDV
— Medical Device Vigilance
ICU
— Intensive Care Unit
GMP
— Good Manufacturing Practice
HQ
— Headquarters (HDQ Preferred)
AMS
— Aseptic Meningitis Syndrome
ARF
— Acute Renal Failure
EEG
— Electro-EncephaloGram
DNA
— Deoxyribose Nucleic Acid
(B)(4)
— Freedom of Information Act Exemption 4, which protects from disclosure ôtrade secrets and commercial
NPI
— National Provider Identifier
HAZMAT
— Hazardous Material
ALARA
— As Low As Reasonably Achievable
IMO
— International Maritime Organization
TDY
— temporary duty (non-unit-related personnel)
NTIS
— National Technical Information Service Technology Administration
PER DIEM
— Per Day allowance for daily travel expenses
TEAE
— Treatment-Emergent Adverse Event
GU
— Genitourinary
AAAS
— American Association for the Advancement of Science
C
— with (usually written with a bar on top of the "c")
USGS
— United States Geological Survey (DOI)
PNR
— Passenger Name Record
COOP
— Continuity of Operations
NSC
— National Security Council
TPN
— Total Parenteral Nutrition
CPAP
— Continuous Positive Airway Pressure
NOS
— Network Operating System
UN
— United Narions
BPR
— Business Process Re-engineering
COP
— Continuation Of Pay
BEA
— Bureau of Economic Analysis
ME
— Medical Examiner
ECRF
— Electronic Case Report Form
MBC
— Minimum Bactericidal Concentration
LF
— Low Frequency
CRF
— Chronic Renal Failure
W3C
— World Wide Web Consortium
ADR
— Adverse Drug Reaction
DKA
— Diabetic Ketoacidosis
OPM
— Office of Personnel Management
AQL
— Acceptable Quality Level
ISS/ISE
— Integrated Summary of Safety / Integrated Summary of Effectiveness
AAO
— American Academy of Ophthalmology
AIS
— Automated Information System
I&O
— Intake & Output
OAI
— Official Action Indicated (serious Food & Drug Administration post-inspection classification)
CRO
— Contract Research Organization
BPA
— Blanket Purchase Agreement
BLM
— Bureau of Land Management of United States Department of the Interior
GAO
— Government Accountability Office [formerly the General Accounting Office]
CIA
— Central Intelligence Agency
OASDI
— Old Age Survivors Disability Insurance
IVP
— Intravenous Pyelogram
RTF
— Rich Text Format
AAP
— American Academy of Pediatrics
FAT
— Factory Acceptance Test
IAW
— In Accordance With
DEA
— Drug Enforcement Administration (U.S. Department of Justice)
ERP
— Enterprise Resource Planning
FTC
— Federal Trade Commission (U.S.)
JPEG
— Joint Photographic Experts Group (24-bit image storage format)
HCT
— Hematocrit
AUC
— Area under the Curve (statistics)
SSA
— Social Security Administration
CJD
— Creutzfeldt-Jakob Disease
AVMA
— American Veterinary Medical Association
CHIP
— Children's Health Insurance Program
AAEP
— American Association of Equine Practitioners
FECA
— Federal Employee's Compensation Act
ADME
— absorption, distribution, metabolism, and excretion
FASAB
— Federal Accounting Standards Advisory Board
DCC
— Document Control Center
ARRT
— American Registry of Radiologic Technologists
ERT
— Emergency Response Team
QOL
— Quality of Life
CM
— Configuration Management
PVC
— Polyvinyl Chloride
SWAT
— Special Weapons and Tactics
ADA
— American Dental Association
HCFA
— Health Care Financing Administration
DUNS
— Data Universal Numbering System
AML
— Acute Myelogenous Leukemia
BMI
— Body Mass Index
COI
— Conflict Of Interest
CHO
— Carbohydrate
TRO
— Temporary Restraining Order
ODI
— Oswestry Disability Index
SEC
— Securities and Exchange Commission (US)
NHANES
— National Health and Nutrition Examination Survey
Y2K
— Year 2000
BNA
— Bureau of National Affairs, Inc.
RNA
— Ribo Nucleic Acid
HTN
— Hypertension
PPP
— Point-to-Point Protocol
USPS
— United States Postal Services
TNTC
— Too Numerous To Count
OPV
— Oral Polio Vaccine
SIDS
— Sudden Infant Death Syndrome
CAPD
— Continuous Ambulatory Peritoneal Dialysis
APHIS
— U.S. Department of Agriculture's Animal and Plant Health Inspection Service
WFI
— Water For Injection (pharmaceutical Term)
482
— FDA form for notice of inspection
CRF
— Case Report Form
DME
— Durable Medical Equipment
EMC
— Electromagnetic Compatibility
NBS
— National Bureau of Standards (US)
ALJ
— Administrative Law Judge
SSRI
— Selective Serotonin Reuptake Inhibitor
USC
— United States Code (book of laws)
NAFTA
— North American Free Trade Agreement
EFTA
— European Free Trade Association (Geneva)
ARDS
— Acute Respiratory Distress Syndrome
EBS
— Emergency Broadcast System
A2LA
— American Association for Laboratory Accreditation
NCC MERP
— National Coordinating Council for Medication Error Reporting and Prevention
ABPI
— Association of the British Pharmaceutical Industry
ITA
— International Trade Administration
CMV
— Cytomegalovirus
IPCS
— International Programme on Chemical Safety
MRP
— material requirements planning
AAFP
— American Academy of Family Physicians
ESD
— Electrostatic Discharge
CVD
— Cardiovascular Disease
I&D
— Incision and Drainage
CRA
— Clinical Research Associate
CME
— Continuing Medical Education
ECE
— Economische Commissie voor Europa (United Nations) (Dutch: Economic Commission for Europe)
CAPA
— Corrective And Preventive Action
T&A
— Time & Attendance
C&S
— Culture and Sensitivity
CSR
— Clinical Study Report
CDRH
— Center for Devices and Radiological Health (Food & Drug Administration)
PIN
— Personal Identification Number
FERC
— Federal Energy Regulatory Commission (U.S.)
IVF
— in vitro fertilization;
APHA
— American Public Health Association
PCR
— Polymerase Chain Reaction
DI
— Diabetes Insipidus
NEC
— not elsewhere classified
UMDNS
— Universal Medical Device Nomenclature System
BSA
— Body Surface Area
PHI
— Protected Health Information
AANS
— American Association of Neurological Surgeons
NOD
— Notice of Deficiency
BMR
— Basal Metabolic Rate
AACR
— American Association for Cancer Research
TCP/IP
— transmission control protocol/internet protocol
AASP
— American Association of Swine Practitioners
CONOPS
— Concept of Operations
NCE
— New Chemical Entity
CRCL
— Creatinine Clearance
HCG
— Human Chorionic Gonadotropin
ALT
— Alanine Aminotransferase
OLE
— Object Linking and Embedding (Microsoft communication protocol)
CPK
— Creatinine Phosphokinase
AABP
— American Association of Bovine Practitioners
NTIA
— National Telecommunications and Information Administration
AHA
— American Hospital Association
MI
— Myocardial Infarction
AALAS
— American Association for Laboratory Animal Science
OPO
— Organ Procurement Organization
AFP
— Alpha Fetoprotein
APIC
— Active Pharmaceutical Ingredients Committee (of CEFIC)
FBS
— fasting blood sugar
ORR
— Objective Response Rate
510(K)
— Food, Drug, and Cosmetic Act Section 501(k), Pre-Market Notification
ASBPO
— Armed Services Blood Program Office
SAL
— Sterility Assurance Level
ACG
— American College of Gastroenterology
HDPE
— High Density Polyethylene Electrical
AAPM
— American Association of Physicists in Medicine's
SMPC
— Summary of Product Characteristics
SPC
— Summary of Product Characteristics
SAMHSA
— Substance Abuse and Mental Health Services Administration
ASM
— American Society for Microbiology
CPE
— Continuing Professional Educational
PR
— Public Relations
EAR
— Export Administration Regulations
AAVMC
— Association of American Veterinary Medical Colleges
AST
— Aspartate Aminotransferase
EH & S
— environmental health and safety
AASRP
— American Association of Small Ruminant Practitioners
IRDM
— Insulin Resistant Diabetes Mellitus
AAI
— American Association of Immunologists
HCO
— Health Care Organization
CHD
— Coronary Heart Disease
CBG
— Capillary Blood Gas
CRP
— Cold Reactive Protein
ICS
— Incident command system
CE
— Continuing Education
TOC
— Total Organic Carbon
AFIA
— American Feed Industry Association
SIP
— Sterilization in Place
DMR
— Device Master Record
USA
— United States Army
ELISA
— enzyme-linked immunosorbent assay
FOUO
— For Official Use Only
BIA
— Bureau of Indian Affairs (U.S.)
EC
— European Community
PUD
— Peptic Ulcer Disease
TLC
— Thin Layer Chromatography
BOS (CBER)
— Building Operations Staff (CBER)
LOCF
— Last Observation Carried Forward
HHS
— U.S. Department of Health and Human Services
TSP
— Thrift Savings Plan
BSL
— Biosafety Level
DMARD
— disease-modifying antirheumatic drug
RH
— Relative Humidity
ULN
— upper limit of normal
PKI
— Public Key Infrastructure (cryptography)
IDDM
— insulin-dependent diabetes mellitus
CCC
— Commodity Credit Corporation
CEA
— Council of Economic Advisors
ADAMHA
— Alcohol, Drug Abuse, and Mental Health Administration (now SAMHSA)
ACIP
— Advisory Committee on Immunization Practices
CCC
— Chinese ceramicware factory code (ORA AofC code)
OOB
— OOS out of business
DC
— Discharge
SBA
— Small Business Administrations
BBB
— Bundle Branch Block
SQ
— Subcutaneous
ANPRM
— Advance Notice of Proposed Rule Making
SHOP
— Small Business Health Options Program
AODM
— Adult-Onset Diabetes Mellitus
CIR
— Cosmetic Ingredient Review
AAVLD
— American Association of Veterinary Laboratory Diagnosticians
ATSDR
— Agency for Toxic Substance and Disease Registry
DNS
— Domain Name Server
BRFSS
— Behavioral Risk Factor Surveillance System
ADAP
— AIDS Drug Assistance Program
BPD
— Bronchopulmonary Dysplasia
CI
— Confidential Informant
DMF
— Drug Master File
AE
— Adverse Event
NABR
— National Association for Biomedical Research
HX
— Medical History
MIC
— Minimum Inhibitory Concentration
PHS
— Public Health Service (U.S.)
VHA
— Veterans Health Administration's
ORNL
— Oak Ridge National Laboratory's
CPT
— Current Procedural Terminology
PIM
— Product Information Management
AHCPR
— Agency for Health Care Policy and Research
ASHD
— AtheroSclerotic Heart Disease
CMP
— Civil Money Penalty
RUO
— Research Use Only
NMFS
— National Marine Fisheries Services
CFOC
— Chief Financial Officers Council
NS
— Not Significant
DC
— discontinue
FMRI
— Functional Magnetic Resonance Imaging
CAP
— College of American Pathologists
NAI
— No Action Indicated (Most Favorable Food & Drug Administration Post-inspection Classification)
NASA
— National Aeronautics and Space Administration (US)
21 CFR PART 314 SUBPART H
— Subpart of Part 314 pertaining to accelerated approval of drugs
FDA BLA
— Food and Drug Administration - Biologicals License Application
DHHS
— Department of Health and Human Services (U.S.)
USP
— United States Pharmacopeia
NOC
— National Operations Center
PBM
— Pharmacy Benefits Management (or Manager)
SAR
— Specific Absorption Rate
TSH
— thyroid stimulating hormone
QWL
— Quality of Work Life
CO
— Compliance Officer
FERS
— Federal Employees Retirement System
NTG
— Nitroglycerin
EEA
— European Economic Area
PDCA
— Plan-do-check-action
FMECA
— failure modes, effects, and criticality analysis
RX
— prescriptions
CP
— Cerebral Palsy of New Jersey
ALL
— Acute Lymphocytic Leukemia
FTT
— Failure To Thrive
PPTP
— Point-to-Point Tunneling Protocol
EINECS
— European Inventory Of Existing Commercial Chemical Substances
CEQ
— Council on Environmental Quality (U.S.)
USCG
— United States Coast Guard
RSS
— Really Simple Syndication
HBP
— High Blood Pressure
WBC
— White blood cells
EMV
— eye-motor-verbal (Glasgow coma scale)
SF
— Standard Form
VMS
— Virtual Memory System
ASIC
— Application Specific Integrated Circuit
SBIR
— Small Business Innovation Research
OSTP
— Office of Science and Technology Policy
IMS
— Information Management System (LTPP)
MSSO
— Maintenance and Support Services Organization
AVDA
— American Veterinary Distributors Association
BMS (OC)
— Broadcast Media Staff (OC)
ANDA
— Abbreviated New Drug Application (for a generic drug)
ARS
— United States Department of Agriculture's Agricultural Research Service
CPP
— Critical Process Parameter
DIA
— Drug Information Association
TVA
— Tennessee Valley Authority (US) (electricity)
ACF
— Administration for Children and Families
CCR
— Center for Cancer Research
LD
— Lethal Dose
IIS
— Internet Information Services
DVD
— Digital Video Disc
DLI
— Donor Lymphocyte Infusion
NCBA
— National Cattlemen's Beef Association
QNS
— Quantity Not Sufficient
CINAHL
— Cumulative Index to Nursing and Allied Health Literature
ASR
— Analyte Specific Reagent
ARENA
— Applied Research Ethics National Association
DSMB
— Data Safety Monitoring Board
MDR
— Medical Device Reporting
PHRMA
— Pharmaceutical Research and Manufacturers of America (formerly PMA, Pharmaceutical Manufacturers Association)
CERT
— Community Emergency Response Team
TDI
— Tolerable Daily Intake
KCAL
— kilocalories
AAHA
— American Animal Hospital Association
DIA
— Defense Intelligence Agency (USA)
COLD
— Chronic Obstructive Lung Disease
SAE
— Serious Adverse Event
RDA
— Recommended Daily Allowance
CAB
— Conformity Assessment Body
NWS
— National Weather Service (formerly U.S. Weather Bureau)
NARA
— United States National Archives And Records Administration
DES
— diethyl sulphate
CFDA
— Catalog of Federal Domestic Assistance
GM
— Genetic Modification
TMJ
— TemporoMandibular Joint (syndrome)
CRO
— Clinical Research Organization
GCP
— Good Clinical Practice
JTF
— Joint Task Force
FONSI
— Finding of no significant impact. See Environmental impact statement (US)
SC
— Subcutaneous
LSD
— Lysergic Acid Diethylamide
MTBF
— Mean Time Between Failures
HDL
— High-Density Lipoprotein (a type of cholesterol)
REMS:
— Risk Evaluation and Mitigation Strategies
QS
— Quality System
EPFA
— European Plasma Fractionation Association
MAC
— Mental Adjustment to Cancer Scale
RIA
— Radio Immuno-Assay
NTP
— National Toxicology Program
RVU
— Relative Value Unit
FPS
— Federal Protective Service
AAAP
— American Association of Avian Pathologists
SNDA
— Supplemental New Drug Application
IV&V
— independent verification and validation
NACMCF
— National Advisory Committee on Microbiological Criteria for Foods
NCI
— National Cancer Institute, USA
GLP
— Good Laboratory Practice
USAHA
— United States Animal Health Association's
A-V
— ArterioVenous
PNNL
— Pacific Northwest National Laboratory (DOE) (US)
MOD 1
— Module One laboratory facility
NICE
— National Institute for Health and Clinical Excellence
PADER
— Periodic Adverse Drug Experience Report
SRD
— System Requirements Document
DIBD
— Development International Birth Date
NASDA
— National Association of State Departments of Agriculture
CP
— Chest Pain
CCU
— Clean Catch Urine
QHS
— quaque hora somni (every night at bedtime)
ASCP
— American Society for Clinical Pathology
HA
— Headache
ODAC
— Oncologic Drugs Advisory Committee (U.S.)
LOQ
— Limit Of Quantification
IBD
— International Birth Date
FEI
— FDA Establishment Identifier (ORA)
HVAC
— Heating, Ventilating, And Air Conditioning
HFA
— HydroFluoroAlkane
CRADA
— Cooperative Research and Development Agreement (with National Institutes of Health)
AMS
— Agricultural Marketing Service
IG
— Inspector General (HHS)
DODAAC
— Department Of Defense Activity Address Code
GEP
— Good Engineering Practice
TDD
— Telecommunications Device for the Deaf
USAID
— United States Agency for International Development
BFAD
— Bureau of Food & Drug Administration
CTC
— Common Toxicity Criteria
DOI
— Department of the Interior (US)
LGA
— large for gestational age
ANA
— Administration for Native Americans
IRM
— Information Resources Management
IB
— Investigator's Brochure
OVR
— Operations Variance Report
NDC
— National Drug Code
RBRVS
— Resource-Based Relative Value Scale
EDMS
— Electronic Document Management System
CEF
— chick embryo fibroblast
APHA
— American Pharmaceutical Association
CN
— Cranial Nerve
NIEHS
— National Institute of Environmental Health Sciences (National Institutes of Health)
LMO
— Living Modified Organism
SDS-PAGE
— Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis
CGL
— Chronic Granulocytic Leukemia
CTFA
— Cosmetic, Toiletry, and Fragrance Association
ICMJE
— International Committee of Medical Journal Editors
VAX
— Virtual Address Extension
BSI
— British Standards Institute
MDI
— Metered-Dose Inhaler
CIOMS
— Council for International Organizations of Medical Sciences
PFGE
— Pulsed-Field Gel Electrophoresis
HCI
— Human-Computer Interaction
NPR
— National Performance Review (office)
CDER
— Center for Drug Evaluation and Research (Food & Drug Administration)
IACUC
— Institutional Animal Care and Use Committee
SUSAR
— Suspected Unexpected Serious Adverse Reactions
CAP
— Corrective Action Plan
CTCAE
— Common Terminology Criteria for Adverse Events
GDS
— Global Distribution System
EMI
— Electro-Magnetic Interference
HAV
— Hepatitis A Virus
IND
— Investigational New Drug
DESI
— Drug Efficacy Study Implementation Notice (Food & Drug Administration, to evaluate drugs in use befaore 1962)
NHC
— United States National Hurricane Center
NCCDPHP
— National Center for Chronic Disease Prevention and Health Promotion
PART
— Program Assessment Rating Tool
CRB
— Change Review Board
JECFA
— Joint (FAO/WHO) Expert Committee on Food Additives
DUR
— Drug Utilization Review
GHTF
— Global Harmonization Task Force
IEEE
— Institute of Electrical and Electronics Engineers
BAM
— Bacteriological Analytical Manual
CIP
— Critical Infrastructure Protection (US)
FFS
— Fee-For-Service
TLA
— Three-Letter Acronym
CSR
— Center for Scientific Review
FORM 482
— Notice Of Inspection
BW
— Body Weight
INCI
— International Nomenclature of Cosmetic Ingredients
DSUR
— Development Safety Update Report
ICRP
— International Commission on Radiological Protection
BIO
— Biotechnology Industry Organization
WB
— Western Blot
AADA
— Abbreviated Antibiotic Drug Application
SEER
— Surveillance, Epidemiology, and End Results
NICHD
— National Institute of Child Health and Human Development
EFD
— Engineering Flow Diagram
WHO-ART
— World Health Organisation Adverse Reaction Terminology
SX
— syndrome X
UIN
— Unique Identification Number
FDASS (OC)
— FDA Safety Staff (OC)
TRB
— Technical Review Board (MRR)
QSR
— Quality System Regulation
ETOH
— Ethyl Alcohol (Ethanol)
AD LIB
— As Much As Needed
SARS
— Severe Acute Respiratory Syndrome
AANN
— American Association of Neurosciences Nurses
PFS
— Piper Fatigue Scale
FNS
— Food and Nutrition Service
R-CHOP
— Drug combination that includes rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
ENL
— Erythema Nodosum Leprosum
E2B
— FDA Working Group that defined Efficacy Topics' Data Elements for Transmission of Adverse Drug Reactions Reports
HIMA
— Health Industry Manufacturers Association
UL
— Underwriters Laboratories
PERV
— Porcine Endogenous Retrovirus
GAP
— Good Agricultural Practice
MEDPAC
— Medicare Payment Advisory Commission
CVA
— Costovertebral Angle
AERS
— Adverse Event Reporting System (Food & Drug Administration)
CMA
— Chemical Manufacturers Association
ANPR
— Advance Notice of Proposed Rulemaking
FDLI
— Food and Drug Law Institute
HIM
— Health Information Management
JAD
— Joint Application Development
WHO
— World Health Organisation
CHMP
— Committee for Medicinal Products for Human Use
GMDN
— Global Medical Device Nomenclature
VAI
— Voluntary Action Indicated (Food & Drug Administration postaudit inspection classification)
LIMS
— Laboratory Information Management System
CSB
— Chemical Safety and Hazard Investigation Board
AFGE
— American Federation of Government Employees
NIA
— National Institute on Aging
PKU
— Phenylketonuria
SMO
— Site Management Organization
DART
— Developmental And Reproductive Toxicology (database / base de données)
EH&S
— Environmental Health and Safety
RFA
— Request For Application
API
— Active Pharmaceutical Ingredient
EHR
— Electronic Health Record
GS
— General Schedule
OQ
— Operational Qualification
IHS
— Indian Health Service
PETA
— People for the Ethical Treatment of Animals
GCLP
— Good Clinical Laboratory Practice
LAF
— Laminar Air Flow
TOI
— Trial Outcome Index
TSE
— Transmissible Spongiform Encephalopathies
CBER
— Center for Biologics Evaluation and Research
ADMS
— Alcohol, Drug Abuse and Mental Health Services
DVT
— Deep Venous Thrombosis
ACR
— American College of Radiology
ICF
— Informed Consent Form
PAO
— Public Affairs Officer
HRSA
— U.S. Health Resources and Services Administration
USP-DI
— United States Pharmacopeia-Drug Information
NVLAP
— National Voluntary Laboratory Accreditation Program
TRI
— Toxics Release Inventory
HTML
— Hyper-Text Markup Language
DICOM
— Digital Imaging and Communications in Medicine
LS/LS
— Life Supporting/Life Sustaining
DURSA
— Data Use and Reciprocal Support Agreement
NIMS
— National Incident Management System
TSCA
— Toxic Substances Control Act of 1976
OASH
— Office of the Assistant Secretary for Health
BATF
— Bureau of Alcohol, Tobacco, & Firearms
URS
— User Requirement Specification
ABI
— Automated Broker Interface
PWS
— Performance Work Statement
CPCSEA
— Committee for the Purpose of Control and Supervision on Experiments on Animals (India)
FDASIA
— Food and Drug Administration Safety and Innovation Act
CAS
— Chemical Abstract Service
NCRP
— National Council on Radiation Protection and Measurements
COP
— Clean Out of Place
CIAC
— Computer Incident Advisory Capability
CEU
— Continuing Education Units
ORANGE BOOK
— Approved Drug Products with Therapeutic Equivalence Evaluations
QAO
— Quality Assurance Office
BB IND
— Biological-Based Investigational New Drug
NEHA
— National Environmental Health Association
AID
— Agency for International Development (U.S.)
CIT
— Center for Information Technology
PK
— Pharmacokinetics
TRALI
— transfusion-related acute lung injury
RCT
— randomized controlled trial
ADVAMED
— Advanced Medical Technology Association
SGA
— small for gestational age
NCHS
— National Center for Health Statistics standards
CTD
— Common Technical Document
A/L
— Annual Leave
SRS
— Spontaneous Reporting System
ETASU
— Elements To Assure Safe Use
NIGMS
— National Institute Of General Medical Sciences (NIH)
FQ
— Fluoroquinolone
VMP
— Validation Master Plan
VSD
— Vaccine Safety Datalink
PTU
— Propylthiouracil
BLA
— Biologics License Application (Food & Drug Administration)
PCS
— Permanent Change Of Station. Reassignment To A Different Duty Station.
MMWR
— Morbidity and Mortality Weekly Report
CGMP
— current Good manufacturing practicess
INDA
— Investigational New Drug Application
QCP
— Quality Control Program
EKG
— electrocardiogram
CIN
— Color Index number (ORA AofC code)
AV
— Atrio-Ventricular (cardiac)
ASA
— American Statistical Association
ACEP
— American College of Emergency Physicians
QSAR
— Quantitative Structure Activity Relationship
TROIF
— Total Recordable Occupational Illness Frequency
ASA
— Aminosalicylic Acid
CWD
— Chronic Wasting Disease
ONC
— Office of the National Coordinator for Health Information Technology (United States Government Health and Human Services)
NAL
— National Agricultural Library
SRCS
— Division of Surveillance, Research, and Communication Support
CPSC
— Consumer Product Safety Commission
DILI
— drug-induced liver injury
CFC
— Combined Federal Campaign
CFG
— Certificate for Foreign Government
FTS
— Federal Telecommunications System
POV
— Privately-Owned Vehicle. A Soldier's Personal Automobile.
NETBEUI
— NETBIOS Extended User Interface
ICH
— International Conference on Harmonization (of Technical Requirements for Registration of Pharmaceuticals for Human Use)
JCAHO
— Joint Commission on Accreditation of Health Care Organizations
CRC
— Clinical Research Coordinator
OOS
— Out Of Specification
AMFAR
— American Foundation for AIDS Research
ERCP
— Endoscopic Retrograde Cholangio-pancreatography Procedures
IMPD
— Investigational Medicinal Product Dossier (EU)
CFU
— Colony Forming Unit (for Bacteria Counting In Water Disinfection)
CASE
— Computer-Aided Software Engineering
FASEB
— Federation of American Societies for Experimental Biology's
MMA
— Medicare Prescription Drug, Improvement and Modernization Act of 2003
NCBI
— National Center for Biotechnology Information
CTC
— Chlortetracycline
DGFPS
— Direccion General de Farmacia y Productos Sanitarios (Directorate General of Pharmacy and Sanitary Products) (Spain)
DFAS
— Defense Finance & Accounting Service
ICD
— Informed Consent Document
MDMA
— Medical Device Manufacturers Association
DAWN
— (U.S.) Drug Abuse Warning Network
PMAP
— Performance Management Appraisal Program
SOPP
— Standard Operating Procedures and Policies
FOI
— Freedom of Information
DTC
— Direct-to-Consumer (drug advertising)
MEDEC
— Medical Devices Canada
FACA
— Federal Advisory Committee Act 1972
ECU
— European Currency Unit
KOS
— Knowledge Organization System
RSS
— Rich Site Summary
MERP
— Medication Error Reporting and Prevention
NACDS
— National Association of Chain Drug Stores
FARAD
— Food Animal Residue Avoidance Databank
ADP
— Alternative Disposition Plan
SCD
— Service Computation Date
SNL
— Sandia National Laboratories
CSR
— Customer Service Record
FACT
— Functional Assessment of Cancer Therapy--General
NEI
— National Eye Institute (National Institutes of Health)
USPSTF
— United States Preventive Services Task Force
CHPA
— Consumer Healthcare Products Association
AOA
— Administration on Aging
DPAMS
— Division of Pre-marketing Assessment III and Manufacturing Science
HFD
— Headquarters, FDA Drug; mail code for Center for Drug Evaluation and Research
PACE
— Patient-centered Assessment and Counseling for Exercise
IQ
— Installation Qualification
NIDA
— National Institute on Drug Abuse (National Institutes of Health)
ERC
— Engineering Research Center
USCA
— United States Code Annotated
IPV
— Inactivated Polio Vaccine
ASAP
— Administrative Systems Automation Project (Food & Drug Administration)
USCS
— United States Customs Service
SHE
— Safety, Health and Environmental
JIC
— Joint Information Center
EFPIA
— European Federation of Pharmaceutical Industries and Associations
DPT
— Diphtheria, Pertussis And Tetanus
ARCRT
— American Registry of Clinical Radiography Technologists
USIA
— United States Information Agency (changed To IIP)
SCOGS
— Select Committee On GRAS (Generally Recognized As Safe) Substances
SPAC
— State Pharmaceutical Administration of China
N.B.
— nota bene (note well)
ABCS
— Active Bacterial Core Surveillance
OSHRC
— Occupational Safety and Health Review Commission
CRMTS
— CBER (Center for Biologics Evaluation and Research) Regulatory Meetings management Tracking System
TESS
— Treatment-Emergent Signs and Symptoms
NHIN
— Nationwide Health Information Network
MFCU
— Medicaid Fraud Control Unit
AIM
— Active Ingredient Manufacturer
APLB (CBER)
— Advertising and Promotional Labeling Branch (Center for Biologics Evaluation and Research)
BGA
— BundesGesundheitsAmt (German Federal Health Office)
AWP
— Average Wholesale Price
HHMI
— Howard Hughes Medical Institute
CAMP
— Childhood Asthma Management Program
DWPE
— Detention without Physical Examination
ASCO
— American Society of Clinical Oncology's
DAL
— Defect Action Level
NIDCR
— National Institute of Dental and Craniofacial Research
ASGE
— American Society for Gastrointestinal Endoscopy
NGA
— National Geospatial-Intelligence Agency (formerly National Imagery and Mapping Agency; US government)
MTCT
— mother-to-child transmission
DRLM
— Device Registration and Listing Module (FURLS)
LRI
— Lower Respiratory Infection
OGE
— Office of Government Ethics (formerly part of Office of Personnel Managment, separate executive branch in 1989)
MF
— Master File
ICRU
— International Commission on Radiation Units and Measurements
CNS
— Congress of Neurological Surgeons
AL
— Annual Leave
HAART
— Highly Active Antiretroviral Therapy ヨ the name commonly given to combinations of anti-HIV drugs
HPFB
— Health Products and Food Branch (Canada)
GXP
— Good "x" Practices (x = any type of practice)
OIP
— Office of International Programs
LOAEL
— Lowest Observed Adverse Effect Level
COE
— Center of Excellence
MMR
— measles, mumps, and rubella
EAS
— Emergency Alert System
LES
— Leave and Earnings Statement
ED
— Effective Dose
CSTE
— Council of State & Territorial Epidemiologists
EWG
— Expert Working Group
NBII
— National Biological Information Infrastructure
LF3
— Low-value Foor or Food-related products, level 3 (between $500 and $1000)
ADMC
— Advance Determination of Medicare Coverage
AHF
— Antihemophilic Factor
PDMP
— Prescription Drug Monitoring Program
RPSGB
— Royal Pharmaceutical Society of Great Britain
VADM
— Vice Admiral
STEPS
— System for Thalidomide Education and Prescribing Safety
NLEM
— National List of Essential Medicines
ORISE
— Oak Ridge Institute for Science and Education
BVB
— Bacterial Vaccine and Allergenic Products Branch
ACS (CDER)
— Advisors and Consultants Staff (Center for Drug Evaluation and Research)
NIBIB
— National Institute of Biomedical Imaging and Bioengineering
D & C
— Dilation and Curettage
RRCC
— Regional Response Coordination Center
QSIT
— Quality System Inspection Technique
SSED
— Summary of Safety and Effectiveness Data
CITES
— Convention on International Trade in Endangered Species of Wild Fauna and Flora
ASTHO
— Association of State and Territorial Health Officials
AC
— Advisory Committee
VFD
— Veterinary Feed Directive
SG
— Surgeon General
BT ACT
— Bioterrorism Act (Public Health Security and Bioterrorism Preparedness and Response Act of 2002)
CSV
— Computer System Validation
SUPAC-IR
— Scale-Up and Post-Approval Changes - Immediate Release
RM
— Raw Material
RDNA
— Recombinant Deoxyribonucleic Acid
VAERS
— Vaccine Adverse Event Reporting System
SPECT
— single-photon emission computed tomography
GHC
— Group Health Cooperative
CBP
— Customs and Border Protection
FFDCA
— Federal Food, Drug and Cosmetic Act of 1938
EDIPI
— Electronic Data Interchange Personal Identifier
SDO
— Standards Development Organization
FSH
— Follicular Stimulating Hormone
DCU
— Document Control Unit
STAMP
— Systematic Technology Assessment of Medical Products
HL7
— Health Level 7 (a not-for-profit ANSI-accredited standards-developing organization (SDO)
NARB
— National Advertising Review Board
USACE
— United States Army Corps of Engineers
QP
— Qualified Person
DBRA
— Division of Biometry and Risk Assessment
CA
— Chemical Abstracts
TVC
— Total Viable Count
HEPA
— High-Efficiency Particulate Air filter
SCR
— System Change Request
ABC
— American Blood Commission
CEFIC
— Conseil Européen des Fédérations de l'Industrie Chimique (European Chemical Industry Council
AAFCO
— Association of American Feed Control Officials
GIS
— Geographical Information System
URL
— Uniform Resource Locator
COS
— Certificate of Suitability
NCDC
— National Centre for Disease Control, India
BCPT
— Breast Cancer Prevention Trial
BOCF
— Baseline Observation Carried Forward
PHPPO
— Public Health Practice Program Office
FEB
— Federal Executive Board
OP 2 (OC)
— Operations Team 2 (OC)
OCR
— Office of Civil Rights
NIAAA
— National Institute on Alcohol Abuse and Alcoholism
HCTZ
— Hydrochlorothiazide
EAA
— essential amino acidsolution
BPE
— Bulk Pharmaceutical Excipients
HSA
— Health Services Administration
SIP
— Summer Internship Program
PERI
— Pharmaceutical Education & Research Institute
COA
— Certificate of Analysis
AWS
— Alternate Work Schedule
BIVAS
— Body Image Visual Analog Scale
OM (CDER)
— Office of Management (Center for Drug Evaluation and Research)
NCEH
— National Center for Environmental Health
APAP
— N-Acetyl-Para-Amino-Phenol
CATCH
— Child and Adolescent Trial for Cardiovascular Health
NIS
— National Inpatient Sample
CRCPD
— Conference of Radiation Control Program Directors
ADEERS
— Adverse Event Expedited Reporting System
HRG
— Health Research Group
USPTO
— United States Patent and Trademark Office
DNP (CDER)
— Division of Neurology Products (Center for Drug Evaluation and Research)
DMAT
— Disaster Medical Assistance Team
NACCHO
— National Association of County and City Health Officials
FD&C ACT
— Federal Food, Drug, and Cosmetic Act of 1938
ORI
— Office of Research Integrity
HSPD
— Homeland Security Presidential Directive
FCCSET
— Federal Coordinating Council for Science, Engineering, and Technology
BPCI ACT
— Biologics Price Competition and Innovation Act of 2009
VEE
— Venezuelan Equine Encephalomyelitis
SCLIR
— Secondary Calibration Laboratories for Ionizing Radiation
FALCPA
— Food Allergen Labeling and Consumer Protection Act
FPLA
— Fair Packaging and Labeling Act of 1967
JINAD
— Generic Investigational New Animal Drug File
3500A
— FDA form for mandatory reporting of adverse events
FFLA
— Family Friendly Leave Act
AMP
— Average Manufacturer Price
PARQ
— Physical Activity Readiness Questionnaire
OIT (CDER)
— Office of Information Technology (Center for Drug Evaluation and Research)
CIRMS
— Council on Ionizing Radiation Measurements and Standards
SRM
— Specified Risk Material
KS
— Kaposi's Sarcoma
NIDDK
— National Institute of Diabetes and Digestive and Kidney Diseases
OPDP
— Office of Prescription Drug Promotion (CDER) (formerly Division of Drug Marketing, Advertisement and
AOB (OC)
— Accounting Operations Branch (OC)
C/CC
— Career or Career Conditional
BECON
— Bioengineering Consortium
CC
— Coordinating Committee
TSCSB (CFSAN)
— Telecommunications and Scientific Computer Support Branch (CFSAN)
MQSA
— Mammography Quality Standards Act of 1992
NIOSH
— National Institute for Occupational Safety and Health (CDC)
GRAS
— Generally Recognized As Safe
JBIG
— Joint Bi-level Image experts Group
CRL
— Complete Response Letter
EDMF
— European Drug Master File
ORP (CDER)
— Office of Regulatory Policy (Center for Drug Evaluation and Research)
RR
— Relative risk of death
NCHSTP
— National Center for HIV, STD, & TB Prevention
PHA
— Public Health Advisory
FAERS
— FDA Adverse Event Reporting System
LRC
— Lipid Research Clinic
NVP
— National Vaccine Program
SBRS
— SENIOR BIOMEDICAL RESEARCH SERVICE
PDB (CDER)
— Prescription Drugs Branch (Center for Drug Evaluation and Research)
2301
— FDA form for transmittal of periodic reports and promotional material for new animal drugs
FFD & C
— Federal Food, Drug and Cosmetic Act of 1938
MLD
— Minimum Lethal Dose
CDASH
— Clinical Data Acquisition Standards Harmonization
LOC
— Level Of Concern
BPAC
— Blood Products Advisory Committee
DCPS
— Defense Civilian Pay System
RAD
— Rapid Application Design
BRAPP
— British Association of Pharmaceutical Physicians
STN
— Submission Tracking Number
DIT (CDRH)
— Division of Information Technology (Center for Drug Evaluation and Research)
MRL
— Maximum Residue Limit
TTTC
— Take Time To Care
C
— Gl With Glasses
NLEA
— Nutrition Labeling and Education Act of 1990
CTDB 1 (CDRH)
— Chemistry and Toxicology Devices Branch 1 (CDRH)
ER
— Extended-Release
NSAPB
— National Surgical Adjuvant Breast and Bowel Project
MCAFT
— Modified Canadian Aerobic Fitness Test
ASPE
— Assistant Secretary for Planning and Evaluation
WFH
— World Federation of Hemophilia
C-TPAT
— Customs-Trade Partnership Against Terrorism
TCS
— Temporary Change of Station
DV
— Daily Values
PADE
— Postmarketing Adverse Drug Experience
PDO
— Protected Designation of Origin
CEARS
— CBER (Center for Biologics Evaluation and Research) Error and Accident Reporting System
AT
— antithrombin III
CHCB (CFSAN)
— Chemical Contaminants Branch (CFSAN)
OD
— Office of the Director
COLA
— Cost Of Living Allowance
CMP/ HMO
— Comprehensive Medical Plan/Health Maintenance Organization
GME
— Graduate Medical Education
DHSS
— Department of Health and Social Security (U.K.)
ESF
— Emergency Support Function
SAP
— Service Access Point
IARC
— International Agency for Research on Cancer
ESIG
— Electronic Signature
TEB (CBER)
— Therapeutics Evaluation Branch (CBER)
M4
— ICH M4 Expert Working Group (EWG) [focusing on Common Technical Documents for sections of the NDA]
DIN
— Drug Identification Number
DFO
— Designated Federal Official
WG
— Wage Grade
KPS
— Karnofsky Performance Status scale
PCP
— Pneumocystis Carinii Pneumoniae
GBL
— Government Bill of Lading
CLSI
— Clinical and Laboratory Standards Institute
ATC
— Anatomical Therapeutic Chemical
AE(S)
— adverse event(s)
SSOP
— Sanitation Standard Operating Procedures
NS/EP
— National Security and Emergency Preparedness
OWH (OC)
— Office of Women's Health (OC)
DONED
— Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices (CDRH)
DTAP
— diphtheria, tetanus and acellular pertussis
PEB 1 (CDRH)
— Postmarket Evaluation Branch 1 (Center for Devices and Radiological Health)
OP (OC)
— Office of Policy (Office of the Commissioner)
DHCP
— Dear Health Care Professional
FORM 3500A
— Mandatory Reporting of Adverse Events
SUPAC-SS
— scale-up and postapproval changes--nonsterile solid
ISSO
— Information Systems Security Officer
ACBSA
— Advisory Committee on Blood Safety and Availability
DCPA (CBER)
— Division of Congressional and Public Affairs (Center for Biologics Evaluation and Research)
NMA
— National Medical Association
UPLC
— Ultra Performance Liquid Chromatography
BISTIC
— Biomedical Information Science and Technology Initiative Consortium
C
— Gl With Correction
RCR
— Replication Competent Retrovirus
NCTR
— National Center for Toxicological Research
NCDCP
— National Council on Prescription Drug Programs
OSHA
— Occupational Safety and Health Administration (U.S. Department of Labor)
DFS (ORA)
— Division of Field Science (ORA)
PMN
— Pre-Market Notification
CT
— Clinical Trial
CIP
— Clean-In-Place
HTLV
— human T-lymphotropic viruse
OM (OC)
— Office of Management (Immediate Office of the Commissioner)
MAH
— Marketing Authorization Holder
DAA
— Designated Approving Authority
CAPAR
— Corrective Action Preventive Action Report
PQRI
— Product Quality Research Institute
NCCAM
— National Center for Complementary and Alternative Medicine
NUCC
— National Uniform Claim Committee
SBOA
— Summary Basis of Approval
USRDS
— United States Renal Data System
EPAR
— European Public Assessment Report
QMIS
— Quality Management Information System
DRLS
— Drug Registration and Listing System
AATB
— American Association of Tissue Banks
CDM
— Clinical Data Management
OBE
— Online Booking Engine
ACRPI
— Association of Clinical Research for the Pharmaceutical Industry
DHF
— Design History File
WITS
— Washington Interagency Telecommunications System
MOD 2
— Module Two laboratory facility
CLT
— Central Limit Theorem
QBD
— Quality by Design
EP
— European Pharmacopoeia
CDC
— Centers for Disease Control and Prevention
C OF A
— Certificate of Analysis
CODEX
— Codex Alimentarius collection of food standards
TEACA
— Trolox-Equivalent Antioxidant Capacity Assay
EPC
— Evidence-based Practice Center
SID
— Source-to-Image Distance
USJFCOM
— United States Joint Forces Command
C & S
— Culture and Sensitivity
CTA
— Clinical Trial Agreement
OIT (CBER)
— Office of Information Technology (Center for Biologics Evaluation and Research)
1932A
— FDA form for veterinary adverse drug reaction, lack of effectiveness, product defect report--voluntary
S/L
— Sick Leave
PDCS (OC)
— Policy Development and Coordination Staff (OC)
NHW
— National Health and Welfare Department (Canada's equivalent of DHHS)
IFT
— Institute of Food Technologists
NF
— National Formulary
CSM
— Committee on Safety of Medicines
HDF
— mail code for CDER (Center for Drug Evaluation and Research)
ECTD
— Electronic Common Technical Document
SOC
— System Organ Classification
FORM 348
— Sponsored Travel
DIHD (CDRH)
— Division of Immunology and Hematology Devices (CDRH)
ACS (CBER)
— Analytical Chemistry Staff (Center for Biologics Evaluation and Research)
RAMP
— Remedial Action Management Program
LR1
— Low-value non-prescription Radiation-emitting products, level 1 (less than $200)
OS (OC)
— Operations Staff (OC)
MEG
— Magnetoencephalography
GXT
— graded exercise tolerance (Stress test)
NLT
— Not Less Than
ITIPS
— Information Technology Investment Portfolio System
PIC
— Pharmaceutical Inspection Convention
MEDDRA
— Medical Dictionary for Regulatory Activities (new global standard medical terminology designed to supersede other terminolgies used in the medical product development process, including COSTART, ICD9 and others)
ENTB (CDRH)
— Ear, Nose, and Throat Devices Branch (CDRH)
AUSA
— Assistant United States Attorney
COTA
— Career Opportunities Training Agreement (HHS)
348
— FDA form for sponsored travel
MUMS ACT
— Minor Use and Minor Species Animal Health Act of 2004
RPMS (OC)
— Regulations Policy and Management Staff (OC)
DSHEA
— Dietary Supplement and Health Education Act of 1994
CEB (CFSAN)
— Compliance and Enforcement Branch (CFSAN)
OFPA
— Organic Foods Production Act of 1990
DSMICA
— Division of Small Manufacturers, International and Consumer Assistance (FDA)
OPB (ORA)
— Operations and Policy Branch (Office of Regulatory Affairs)
DPS
— Division of Post-marketing Surveillance
CA
— Competent Authority
ORTF
— Obesity Research Task Force
ABN
— Advance Beneficiary Notice
X-SCID
— X-linked severe combined immunodeficiency disorder
LOEL
— Lowest Observed Effect Level
SUBPART H
— That subpart of 21 CFR Part 314 pertaining to accelerated approval of drugs
CO
— Commissioned Officer
PEB (CBER)
— Planning and Evaluation Branch (CBER)
OM (CBER)
— Office of Management (Center for Biologics Evaluation and Research)
IO
— Immediate Office
CSV
— Comma Separated Values file format
BARDA
— Biomedical Advanced Research and Development Authority
PDE
— Permitted Daily Exposure
ISBT 128
— International Society of Blood Transfusion standard for blood, tissue, and organ identification
FSMS
— Food Safety Management System
FAN
— Food Allergy Network
RSO
— Radiation Safety Officer
ADE/ADER
— Adverse Drug Experience/Adverse Drug Experience Report
CGTP
— Current Good Tissue Practice
WONF
— With Other Natural Flavors
DD (CVM)
— District Director (Center for Veterinary Medicine)
CTDB 2
— Chemistry and Toxicology Devices Branch 2
TOPRA
— The Organisation for Professionals in Regulatory Affairs
GIF
— Graphics Interchange Format
QD
— Quaque in Die (once daily)
MA
— Marketing Authorization
NCL
— National Consumers League
AAPHP
— American Association of Public Health Physicians
FSANZ
— Food Standards Australia New Zealand's
DDES (CFSAN)
— Division of Dairy and Egg Safety (CFSAN)
DNCE (CDER)
— Division of Nonprescripton Clinical Evaluation (CDER)
QL
— Quality of Life
CHSB (CFSAN)
— Chemical Hazards Science Branch (CFSAN)
HHI
— Herth Hope Index
ADRAC
— Adverse Drug Reactions Advisory Committee
FORM 356V
— New Animal Drug Application
PUFI
— Packed Under Federal Inspection
AMI
— American Meat Institute
OIVD (CDRH)
— Office of In Vitro Diagnostic Device Evaluation and Safety (CDRH)
SEIU
— Service Employees International Union
BPC
— Bulk Pharmaceutical Chemical
ACGME
— Accreditation Council for Graduate Medical Education
OSC (CVM)
— Office of Surveillance and Compliance (CVM)
DIAM (CDRH)
— Division of Imaging and Applied Mathematics (CDRH)
BFARM
— Bundesinstitut Fur Arzneimittel und Medizinprodukte (German Ministry of Health)
CDSA
— Controlled Drugs and Substances Act (Canada)
PNSI
— Prior Notice System Interface
ACP
— Advance Care Planning
CPGM
— Compliance Program Guidance Manual
TPLC
— Total Product Life Cycle
CIB (CFSAN)
— Compliance Information Branch (CFSAN)
CTIA
— Cellular Telecommunications and Internet Association's
CPB (CFSAN)
— Compliance Programs Branch (CFSAN)
DP
— Drug Product
IGIV
— Immune Globulin Intravenous
CS
— Civil Service
FURLS
— FDA Uniform Registration & Listing System
VMO
— Veterinary Medical Officer
QIJ
— Quality Inspection Journal
GEBAT
— Government Excess Baggage Authorization Ticket
DCB (CFSAN)
— Domestic Compliance Branch (CFSAN)
DGSS (CFSAN)
— Division of General Scientific Support (CFSAN)
COOP
— Continuity of Operations Procedure
RMB (CBER)
— Resource Management Branch (CBER)
ECT
— Electro-Convulsive Therapy
PA
— Physical Activity
CTAP
— Career Transition Assistance Plan
FOB
— Federal Office Building
BPL
— Biologic Product License Number
IMCC
— Information Management Coordinating Committee
APHL
— Association of Public Health Laboratories
BCB (CFSAN)
— Bioanalytical Chemistry Branch (CFSAN)
FQPA
— Food Quality Protection Act of 1996
DCLD (CDRH)
— Division of Clinical Laboratory Devices (CDRH)
DMIP
— Division of Medical Imaging Products (CDER)
CCB (CFSAN)
— Color Certification Branch (CFSAN)
FTE
— Full-Time Equivalent
QMS (CDER)
— Quality Management Staff (CDER)
TTY
— TeleTYpewriter
WMS (OC)
— Website Management Staff (OC)
ACSM
— American College of Sports Medicine's
GPRD
— General Practice Research Database
OO (CFSAN)
— Office of Operations (CFSAN)
BP
— British Pharmacopoeia
U
— Units
PAI
— Pre-Approval Inspection
WISQARS
— Web-based Injury Statistics Query and Reporting System
OPHEP
— Office of Public Health Emergency Preparedness
483
— FDA form used as a written notice of deficiencies found in inspections
BARQA
— British Association of Research Quality Assurance
FD-1932
— FDA form, Veterinary Adverse Drug Reaction, lack of effectiveness, product defect report - Mandatory
USFDA
— United States Food & Drug Administration
VMB (CFSAN)
— Virulence Mechanisms Branch (CFSAN)
BSC
— Biological Safety Cabinet
BIMO
— bioresearch monitoring
S&E
— Safety and Effectiveness
OEO (OC)
— Office of Executive Operations (OC)
ACCME
— Accreditation Council for Continuing Medical Education
CHAMPVA
— Civilian Health And Medical Program Of The Department Of Veterans Affairs
OP 1 (OC)
— Operations Team 1 (OC)
TV
— Travel Voucher
CTDB 2 (CDRH)
— Chemistry and Toxicology Devices Branch 2 (CDRH)
DEB (CFAN)
— Dairy and Egg Branch (CFSAN)
OIT (OC)
— Office of Information Technology (Immediate Office of the Commissioner)
FLETC
— Federal Law Enforcement Training Center
DRB (CBER)
— Devices Review Branch (CBER)
UFMS
— Unified Financial Management System
OCP (OC)
— Office of Combination Products (OC)
PEB 2 (CDRH)
— Postmarket Evaluation Branch 2 (Center for Devices and Radiological Health)
APTF
— Application Policy Task Force
ADAA
— Animal Drug Availability Act of 1996
CPID
— Certified Product Information Document (Canada)
CIAO
— Critical Infrastructure Assurance Office
CSO
— Consumer Safety Officer
VVB (CBER)
— Viral Vaccines Branch (CBER)
WPADP
— Working Party on Automation and Data Processing
RPMCC
— Regulatory Project Management Coordinating Committee (CDER)
CMS
— Centers for Medicare and Medicaid Services (formerly Health Care Financing Administration)
PTS (CBER)
— Product Testing Section (CBER)
PSSB (CFSAN)
— Program Support Services Branch (CFSAN)
ASAS
— American Society of Animal Science
BIRAMS
— Biologics Investigational and Related Applications Management System
CFN
— Central File Number
FTB (CFSAN)
— Food Technology Branch (CFSAN)
DRF
— Dose Range Findings
POB
— Program Operations Branch
RLD
— Reference Listed Drug
FDA-WO
— Food and Drug Administration White Oak campus
GMID
— Global Market Information Database
OLA (OC)
— Office of Legislative Affairs (Office of the Commissioner)
DPD (OC)
— Division of Portfolio Development (OC)
CCRC
— Certified Clinical Research Coordinator
FERN
— Food Emergency Response Network
PAP
— Patient Assistance Program
ODM
— Operational Data Model
ITS (CBER)
— Information Technology Staff (CBER)
BMB (CFSAN)
— Bioanalytical Methods Branch (CFSAN)
CTDB 1
— Chemistry and Toxicology Devices Branch 1
VEB (CBER)
— Vaccine Evaluation Branch (CBER)
COB (OC)
— Contract Operations Branch (Office of the Commissioner)
SPCS (CDER)
— Safety Policy and Communications Staff (CDER)
DDDP (CDER)
— Division of Dermatology and Dental Products (CDER)
CRTP
— Clinical Research Training Program
BOCB (CFSAN)
— Biological and Organic Chemistry Branch (CFSAN)
CDISC
— Clinical Data Interchange Standards Consortium (formerly a DIA special interest group called the Clinical Data Interchange Standards Committee)
ER/ES
— Electronic Records/Electronic Signatures
AIMDD
— Active Implantable Medical Device Directive
INV SAMPLE
— INVestigational Sample
INADA
— Investigational New Animal Drug Application
IMS (CDRH)
— Issues Management Staff (CDRH)
ACPM
— American College of Preventive Medicine
TURBO EIR
— Turbo Establishment Inspection Report (ORA)
CAPLA
— Computer-Assisted Product License Application
US & R
— urban search and rescue
OIT (ORA)
— Office of Information Technology (Office of Regulatory Affairs)
JPMA
— Japan Pharmaceutical Manufacturers Association
ERB (CFSAN)
— Elemental Research Branch (CFSAN)
PHIN
— Public Health Information Network
CRMT (OC)
— Cosmetics Toxicology Branch (CFSAN)
FPB (CDRH)
— Field Programs Branch (Center for Devices and Radiological Health)
CAAT
— Center for Alternatives to Animal Testing
SPTPB (CFSAN)
— Seafood Processing and Technology Policy Branch (CFSAN)
NVICP
— National Vaccine Injury Compensation Program
APIFARMA
— Associação Portuguesa da Indústria FARMAcêutica (Association of the Portuguese Pharmaceutical Industries)
CRB (CBER)
— Clinical Review Branch (CBER)
CTEB (CFSAN)
— Cosmetics Technology Branch (CFSAN)
CE MARK
— CE (Conformite Europeene or European Conformity) marking
QID
— Quater In Die (Four Times a Day)
ASRM
— American Society for Reproductive Medicine
DRP (CBER)
— Division of Regulations and Policy (CBER)
NINR
— National Institute of Nursing Research
CIS
— Cancer Information Service
ACLAM
— American College of Laboratory Animal Medicine
BVC
— British Veterinary Codex
SECT 505(B)(2)
— New drug application
PAS (CDRH)
— Premarket Approval Section (CDRH)
PEB (ORA)
— Program Evaluation Branch (ORA)
SNOMED-RT
— Systematized Nomenclature of Medicine Reference Terminology
IBR (CFSAN)
— Import Branch (CFSAN)
PN
— Product Name
USTR
— United States Trade Representative
ASD (HD)
— Assistant Secretary of Defense for Homeland Defense
ELEXNET
— Electronic Laboratory Exchange Network
NEDSS
— National Electronic Disease Surveillance System
PFO
— Principal Federal Official
DTP
— Direct-to-Patient
DHC
— dioxin health certificate (ORA AofC code)
FDARA
— Food and Drug Administration Revitalization Act
CCP
— Critical Control Point
RU-486
— Roussel Uclaf drug number 486
CFIA
— Canadian Food Inspection Agency
GINAD
— Generic Investigational New Animal Drug file
OVRR (CBER)
— Office of Vaccines Research and Review (CBER)
BGH
— Bovine Growth Hormone
SPR
— System Problem Report
CHLIA
— chemi-luminescent immunoassay
CLIA
— Clinical Laboratory Improvement Amendment
SMSB (CFSAN)
— Spectroscopy and Mass Spectrometry Branch (CFSAN)
HHS SERT
— Health and Human Services Secretary's Emergency Response Team
DEB
— Dairy and Egg Branch
CPMP
— Committee for Proprietary Medicinal Products
OSO
— Office of Security Operations
BSC
— Business Service Center
CMGB (CDER)
— Cae Management and Guidance Branch (CDER)
PQG
— Pharmaceutical Quality Group
CAPLAR
— Computer-Assisted Product License Application Review
DCF
— Data Clarification request Form
RIBAル
— recombinant immunoblot assay (Chiron ᆴ)
JTR
— Joint Travel Regulations
MAD
— Multiple Ascending Dose
CDA
— Clinical Document Architecture
HAM/TSP
— HTLV-I-associated myelopathy / tropical spastic paraparesis
OS (CDER)
— Operations Staff (CDER)
NDF-RT
— National Drug File Reference Terminology
OVST (CFSAN)
— Operations and Veterinary Support Team (CFSAN)
FDCA
— Federal Food, Drug, and Cosmetic Act of 1938
DMIHP (CDER)
— Division of Medical Imaging and Hematology Products (CDER)
CUE
— Confidential Unit Exclusion
PTO
— Patent and Trademark Office (U.S. Department of Commerce)
LOB (ORA)
— Laboratory Operations Branch (ORA)
FAM
— Foreign Affairs Manual
LF1
— Low-value Food or Food-related products, level 1 (less than $200)
1932
— FDA form for veterinary adverse drug reaction, lack of effectiveness, product defect report--mandatory
OCI (ORA)
— Office of Criminal Investigations (ORA)
PB (CFSAN)
— Pathology Branch (Center for Food Safety and Applied Nutrition)
DDM (NCTR)
— Deputy Director for Management (National Center for Toxicological Research)
SCSB (CFSAN)
— Scientific Computer Support Branch (CFSAN)
DPEM (ORA)
— Division of Planning, Evaluation and Management (ORA)
PEB (CDRH)
— Program Enforcement Branch (CDRH)
AAALAC
— Association for the Assessment and Accreditation of Laboratory Animal Care International
ACB (CDRH)
— Accreditation and Certification Branch (CDRH)
ICCBBA
— International Council for Commonality in Blood Banking Automation, Inc.
NCVIA
— National Childhood Vaccine Injury Act of 1986
FDC
— Food Drug and Cosmetic
VSB (CBER)
— Vaccine Safety Branch (CBER)
ACCP
— American College of Clinical Pharmacology
DPL
— Drug Product Licensing (Canada)
MSS (CVM)
— Management Support Staff (CDRH)
ISAC
— Information Sharing and Analysis Center
DPMU
— Disaster Portable Morgue Unit
AER
— Adverse Event Reporting
HNK CELLS
— human neonatal kidney cells
ACPE
— Accreditation Council for Pharmacy Education
OM (CVM)
— Office of Management (Center for Veterinary Medicine)
CC
— Clinical Center
SOAB (OC)
— Systems and Office Automation Branch (Immediate Office of the Commissioner)
SC (CDRH)
— Staff College (Center for Devices and Radiological Health)
NDE/MIS
— New Drug Evaluation Management Information System
STS (CBER)
— Standards and Testing Staff (CBER)
MAPCB (CDER)
— Manufacturing Assessment & Pre-Approval Compliance Branch (CDER)
AHIC
— American Health Information Community
PBSC
— Peripheral Blood Stem Cell
EFOIA
— Electronic Freedom of Information Act
BPHC
— Bureau of Primary Health Care
MSU
— Medical Statistics Unit
AMG
— ArzeneiMittelGesetz (West Germany drug law)
BDR
— Budget Data Request
GTL (NCTR)
— Genetic Toxicology Laboratory (NCTR)
ACE
— Automated Commercial Environment (US Customs)
DRARD (CDRH)
— Division of Reproductive, Abdominal and Radiological Devices (CDRH)
NOAEL
— No Observable Adverse Effect Level
AIP
— Application Integrity Policy
BIOB (CFSAN)
— Biostatistics Branch (CFSAN)
CS (OC)
— Communications Staff (OC)
DUSM
— Deputy United States Marshal (U.S. Department of Justice)
SAPB (CFSAN)
— Shellfish and Aquaculture Policy Branch (CFSAN)
DFO (OC)
— Division of Field Operations (OC)
GOVTRIP
— government travel website operated by Northrop Grumman
PHPS
— Public Health Prevention Service
DDES
— Division of Dairy and Egg Safety
FDAMA
— Food and Drug Administration Modernization Act of 1997
DCGM (OC)
— Division of Contracts and Grants Management (OC)
MAPP
— Manual of Policy and Procedures
QBR
— Question-Based Review
TPP
— Target Product Profile
FASS
— Federation of Animal Science Societies
AOAC
— Association of Official Analytical Chemists
ENG (OC)
— Engineering Team (OC)
TRX
— Total number of Prescriptions
CCBC
— Council of Community Blood Centers
MB (CFSAN)
— Microanalytical Evaluations Branch of the Center for Food Safety and Applied Nutrition
C & R
— corrections and removals
CCST (CFSAN)
— Clinical Chemistry Support Team (CFSAN)
AMDUCA
— Animal Medicinal Drug Use Clarification Act of 1994
LESTD (CBER)
— Laboratory of Enteric and Sexually Transmitted Diseases (CBER)
RAC
— Recombinant-DNA Advisory Committee
GRASE
— Generally Recognized As Safe and Effective
NCSES
— National Center for Science and Engineering Statistics (NSF)
CAPRA
— Canadian Association of Professional Regulatory Affairs
IUO
— investigation use only
ACC
— RCHSA (Radiation Control for Health and Safety Act) ACCession number
USBR
— Bureau of Reclamation (U.S. Department of the Interior)
OSG
— Office of the Surgeon General
PAHO
— Pan American Health Organization
POA
— privately owned automobile
BRMD
— Bureau of Radiation and Medical Devices
PMOA
— Primary Mode Of Action
CCFAC
— Codex Committee on Food Additives and Contaminants
FCRDC
— Frederick Cancer Research and Development Center
OHRMS
— Office of Human Resources and Management Services
CBIAC
— Chemical and Biological Defense Information Analysis Center
GDUF
— Generic Drug User Fees
TO
— Transportation Officer
RODS
— Real-Time Outbreak & Disease Surveillance System
OEL
— Occupational Exposure Level
HFZ
— Headquarters, FDA code Z; mail code for Center for Devices and Radiological Health
EVS (OC)
— Evaluation Staff (OC)
SRD
— Swine Respiratory Disease
ºº
— sections û shorthand symbol used to designate sections in a legal document; as in ºº201(m), 301(k) o
DCRMS (CDER)
— Division of Compliance Risk Management and Surveillance (CDER)
CFA
— Catfish Farmers of America
CMCCC
— Chemistry and Manufacturing Controls Coordinating Committee
SUPAC
— Scale-Up and Postapproval Changes
DMIRDP (CDER)
— Division of Medical Imaging and Radiopharmaceutical Drug Products (CDER)
EDRLS
— Electronic Drug Registration and Listing Systems
M2
— ICH M2 Expert Working Group (EWG) [electronic standards for transmission of regulatory information]
RMS
— Regulatory Management System
NMT
— Not More Than
CTEP
— Cancer Therapy Evaluation Program
GEMCRIS
— Genetic Modification Clinical Research Information System (NIH)
ACLAD
— American Committee on Laboratory Animal Diseases
QSR
— Quality System Record
PPE
— Pay Period Ending
DSORD
— Division of Surgical, Orthopedic, and Restorative Devices
FDERA
— Food and Drug Export Reform and Enhancement Act of 1996
DNPL (CFSAN)
— Division of Nutrition Programs and Labeling (Center for Food Safety and Applied Nutrition)
IFIC
— International Food Information Council
OCS
— Office of the Chief of Staff
AB (CDRH)
— Analysis Branch (CDRH)
OP 3 (OC)
— Operations Team 3 (OC)
EML
— Environmental Measurement Laboratory
PERT
— Product-enhanced Reverse Transcriptase
EDIFACT
— Electronic Data Interchange for Administration, Commerce, and Transportation
PPQ
— Plant Protection and Quarantine
ITB (CFSAN)
— Immunotoxicology Branch (CFSAN)
DMETS (CDER)
— Division of Medical Errors and Technical Support (CDER)
PDCS
— Policy Development and Coordination Staff
WPS (OC)
— Workforce Programs Staff (OC)
ACLA
— American Clinical Laboratory Association
FCO
— Federal Coordinating Officer (in disaster areas)
HCCN
— Health Center-Controlled Network
ADCOM
— ADvisory COMmittee
AFIP
— Armed Forces Institute of Pathology (DoD)
VCRP
— Voluntary Cosmetic Registration Program
PAITS
— Pre-Approval Inspection Tracking System
NAION
— non-arteritic anterior ischemic optic neuropathy
AT (OC)
— Acquisitions Team (OC)
COOP
— Continuity of Operations Policy
CAFDAS
— Committee for the Advancement of FDA Science
DES
— Drug Eluting Stent
OP 4 (OC)
— Operations Team 4 (OC)
EUP
— Experimental Use Permit
DIOP (ORA)
— Division of Import Operations and Policy (ORA)
GCPB II (CDER)
— Good Clinical Practice Branch II (CDER)
SL
— Signature Line
GSFA
— General Standard for Food Additives
AHFS
— American Hospital Formulary Service
IDR
— Idiosyncratic Drug Reaction
RAC
— Raw Agricultural Commodity
NMI
— Non-Medicinal Ingredient
MIRA
— Medicare Innovation Responsiveness Act of 2003
FEDRIP
— FEDeral Research In Progress Database
OITSS (OC)
— Office of Information Technology Shared Services (Immediate Office of the Commissioner)
DEPI (CBER)
— Division of Ethics and Program Integrity (CBER)
ABIFARMA
— Brazilian Association of the Pharmaceutical Industry
OSHC (OC)
— Office of Science and Health Coordination (OC)
TEPRSSC
— Technical Electronic Product Radiation Safety Standards Committee
NEP
— National Exercise Program
CFSAN
— Center for Food Safety and Applied Nutrition
DPEB (CBER)
— Division of Planning, Evaluation and Budget (CBER)
DCRER (CFSAN)
— Division of Chemistry Research and Environmental Review (CFSAN)
ECS (OC)
— Economics Staff (OC)
ICD-9-CM
— International Classification of Diseases, Ninth Revision, Clinical Modification
ELS
— Establishment License Supplement
DAAS
— Division of Aging and Adult Services
MVB (CFSAN)
— Molecular Virology Branch (CFSAN)
PPT
— Plasma Preparation Tube
DMPQ (CBER)
— Division of Manufacturing and Product Quality (CBER)
RAC
— Reviewer Affairs Committee
ADEC
— Australian Drug Evaluation Committee
OER (OC)
— Office of External Relations (OC)
GOVCC
— government travel charge card
COSTART
— Coding Symbols for Thesaurus of Adverse Reaction Terms
DHRD (ORA)
— Division of Human Resources Development (ORA)
IDBD
— Infectious Disease Biomarker Database
OPPL (OC)
— Office of Policy, Planning and Legislation (OC)
ALJ (OC)
— Office of the Administrative Law Judge (OC)
FDAS
— Defense Finance and Accounting Services
DPFRM (CFSAN)
— Division of Planning and Financial Resources Management (CFSAN)
NATAG
— North American Technical Advisory Group
EMOPS (OC)
— Office of Emergency Operations (OC)
WAE
— When Actually Employed
QOD
— Quaque Altere Die (take every other day)
DMARDS
— disease-modifying antirheumatic drug
IB (CFSAN)
— Immunobiology Branch (CFSAN)
DDMAC (CDER)
— Division of Drug Marketing, Advertising and Communication (CDER)
AIMBE
— American Institute For Medical and Biological Engineering
COOP
— Continuity of Operations Program
ASCPT
— American Society for Clinical Pharmacology and Therapeutics
PCBE
— President's Council on Bioethics
OCER (CDRH)
— Office of Communication, Education and Radiological Programs (CDRH)
LCDC
— Laboratory Centre for Disease Control
RCHSA
— Radiation Control for Health and Safety Act of 1968
ICLAS
— International Council for Laboratory Animal Science
NMDP
— National Marrow Donor Program
IMDB (CDRH)
— Immunology and Molecular Diagnostics Devices Branch (CDRH)
NTB (CFSAN)
— Neurotoxicology Branch (CFSAN)
OSHI (OC)
— Office of Special Health Issues (OC)
NEMA
— National Emergency Management Association
NALBOH
— National Association of Local Boards of Health
PNC
— Prior Notice Center
WIN
— Welfare Information Network
DESE (CDRH)
— Division of Electrical and Software Engineering (CDRH)
BC/BS
— Blue Cross and Blue Shield
NSR
— Non-Significant Risk
MIS (OC)
— Management Initiatives Staff (OC)
DMST (CFSAN)
— Division of Market Studies (CFSAN)
ANCOVA
— Analysis of Covariance
OOPD
— Office of Orphan Product Development (FDA)
RIBAÖ
— recombinant immunoblot assay (Chiron «)
MPEG
— Moving Pictures Experts Group
USFS
— United States Forest Service (U.S. Department of Agriculture)
OVST
— Operations and Veterinary Support Team
MRB (CFSAN)
— Methods Research Branch (Center for Food Safety and Applied Nutrition)
NNMC
— National Naval Medical Center
COP
— Coastal Ocean Program
NCPDP
— National Council for Prescription Drug Programs
GCPB I (CDER)
— Good Clinical Practice Branch I (CDER)
3RS
— Recruitment and Relocation Bonuses and Retention Allowances
HFS
— Headquarters, FDA Safety; mail code for Center for Food Safety and Applied Nutrition
SHEMS
— Safety, Health, and Environmental Management Section
BLS
— Biologics License Supplement
BGMA
— British Generic Manufacturers Association
FFRM
— Food Facility Registration Module (FURLS)
GCSL (CFSAN)
— Gulf Coast Seafood Laboratory (Dauphin Island, Alabama) (CFSAN)
DTBIMP (CDER)
— Division of Therapeutic Biological Internal Medicine Products (CDER)
DEIO (ORA)
— Division of Emergency and Investigational Operations (ORA)
DMT (CVM)
— Division of Manufacturing Technologies (CVM)
HBOT
— Hyperbaric Oxygen Therapy
IPOAB (CDRH)
— Information Processing and Office Automation Branch (CDRH)
CND (CDRH)
— Cardiovascular/Neurological Devices Branch (CDRH)
HFEB (CDRH)
— Human Factors Engineering Branch (CDRH)
TDDS
— Transdermal Drug Delivery System
DMPQ (CDER)
— Division of Manufacturing and Product Quality (CDER)
DCIQA (ORA)
— Division of Compliance Information and Quality Assurance (ORA)
USITC
— United States International Trade Commission
COTT
— Committee Of Ten Thousand
RMCC
— Review Management Coordinating Committee
3500
— FDA form for voluntary reporting of adverse events
DOED (CDRH)
— Division of Ophthalmic, Ear, Nose and Throat Devices (CDRH)
EB (NCTR)
— Engineering Branch (NCTR)
PICNIC
— Professionals and Citizens Network for Integrated Care
ACMP
— American College of Medical Physics
SBA
— Summary Basis of Approval
FOP
— Financial Operating Plan
REMS
— Risk Evaluation and Mitigation Strategy
GTIB (CBER)
— Gene Transfer and Immunogenicity Branch (CBER)
DFEM (NCTR)
— Division of Facilities Engineering and Maintenance (NCTR)
IIG
— Inactive Ingredient Guide
TSA
— Transportation Security Administration
MMAB (CFSAN)
— Microbiological Methods Application Branch of the Center for Food Safety and Applied Nutrition
ODE III
— Office of Drug Evaluation III (CDER)
ASC
— Advertising Standards Council
OCOD
— Office of Communication Outreach and Development (CBER)
FASA
— Federal Acquisition Streamlining Act (of 1994)
LWC
— Lead Wire or patient Cable
ESRA
— European Society of Regulatory Affairs
WRAIR
— Walter Reed Army Institute of Research
RAE
— Remedial Action Exemption
DRC (CVM)
— Division of Residue Chemistry (CVM)
OPS (CDER)
— Office of Pharmaceutical Science (CDER)
OMT
— Oral Mucosal Transudate
ECDT
— Electronic Common Technical Document
CEB (CDER)
— Clinical Evaluation Branch (CBER)
DEMO (CDRH)
— Division of Ethics and Management Operations (CDRH)
MITA
— Medicaid Information Technology Architecture
DMEPA (CDER)
— Division of Medical Error Prevention and Analysis
CFR
— Contract Financial Requirements
MOC
— Management and Operations Council
GRP
— Good Review Practice
COTB (CBER)
— Communication Technology Branch (CBER)
DCCA (CBER)
— Division of Communication and Consumer Affairs (CBER)
COCB
— Communication and Coordination Branch
RADAR
— Risk Assessment of Drugs Analysis and Response
PEP
— Performance Evaluation Plan
DSP (OC)
— Division of Strategic Projects (OC)
GTB (CBER)
— Gene Therapies Branch (CBER)
JMO
— Japanese Maintenance Organization
PP
— Pay Period
NACHO
— National Association of County Health Officials
3R
— Recruitment, Relocation bonuses, and Retention allowances
DPQR (CDER)
— Division of Product Quality Research (CDER)
FD-483
— FDA form, Written Notice of Deficiencies Found in Inspections
OPPB
— Office of Policy Planning and Budget
ADRM (CBER)
— Associate Director for Review Management (CBER)
DTD (CDER)
— Division of Training and Development (CDER)
EOS (CDER)
— Executive Operations Staff (CDER)
DIVBT (CFSAN)
— Division of In Vitro and Biochemical Toxicology (CFSAN)
TOA
— Total Obligation Authority
VRBPAC
— Vaccines and Related Biological Products Advisory Committee
ORP (CFSAN)
— Office of Regulations and Policy (Center for Food Safety and Applied Nutrition)
LRIT (CFSAN)
— Labeling Regulations Implementation Team (CFSAN)
CMGB
— Cae Management and Guidance Branch
NIFC
— National Interagency Fire Center
BDB
— Biologic Devices Branch (CBER)
SMCC
— Standards Management Coordinating Committee
OGUD (CDRH)
— Obstetrics and Gynecology Devices Branch (CDRH)
NOEL
— no observed effect level
AMPI
— Associated Milk Producers Inc.
OARSA
— Office of Applied Research and Safety Assessment
DMEP (CDER)
— Division of Metabolism and Endocrinology Products (CDER)
DSI (CDER)
— Division of Scientific Investigation (CDER)
SPCS
— Safety Policy and Communications Staff
OCIO (OC)
— Office of the Chief Information Officer (OC)
SUD
— Sudden Unexpected Death
MUMS
— Minor Use and Minor Species Animal Health Act of 2004
TRAC
— Tolerance Reassessment Advisory Committee
SIREN
— Scientific Information Retrieval and Exchange Network (CFSAN)
OES (OC)
— Office of Executive Secretariat (OC)
CSB (OC)
— Customer Support Branch (Office of the Commissioner)
EPMS
— Employee Performance Management System
CET (CFSAN)
— Clinical Evaluation Team (Center for Food Safety and Applied Nutrition)
CMHS
— Center for Mental Health Services
BHPR
— Bureau of Health Professions
MMDB (CFSAN)
— Microbial Methods Development Branch (CFSAN)
DBM (CDRH)
— Division of Bioresearch Monitoring (CDRH)
356V
— FDA form for new animal drug appication
FORM 483
— Written Notice Of Deficiencies Found In Inspections
DDMAC
— Division of Drug Marketing, Advertising, and Communications
CNPP
— USDA Center for Nutrition Policy and Promotion
ITDS
— International Trade Data System
SDM
— System Development Methodology
UNAIDS
— Joint United Nations Program on HIV/AIDS
ISMP
— Institute for Safe Medication Practices
DD
— Division Director
LNC
— Labeling and Nomenclature Committee
ADE
— Adverse Drug Event
WTA
— WITHHOLDING TAX ALLOWANCE
GHDB (CDRH)
— General Hospital Devices Branch (CDRH)
LRSP (CBER)
— Laboratory of Respiratory and Special Pathogens (CBER)
ODE IV (CDER)
— Office of Drug Evaluation IV (CDER)
RBC
— Red Blood Cells
AFAB
— Absorbable Fibrin Adhesive Bandage
NPCC
— National Poison Control Center
TBSB (CBER)
— Therapeutics and Blood Safety Branch (CBER)
COOP
— Continuity of Operations Project
BID
— Bis In Die (Twice Daily)
CTS
— Correspondence Tracking System
R&E
— Recall and Emergency
HCPCS
— HCFA (Health Care Financing Administration) Common Procedure Coding System
NIDRR
— National Institute on Disability and Rehabilitation Research
FORM 1932
— Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report - Mandatory
DDI (CDER)
— Division of Drug Information (CDER)
ACOL
— Acceptable Carry-Over Limit
ODE I
— Office of Drug Evaluation I (CDER)
IDL
— International Date Line
AIMS
— Agency Information Management System
CIB
— Clinical Investigator's Brochure
DBEC (OC)
— Division of Budget Execution and Control (OC)
OCM (OC)
— Office of Crisis Management (OC)
RR
— repeatedly reactive
CTTI
— Clinical Trials Transformation Initiative
FCIC
— Federal Consumer Information Center
PCBS
— polychlorinated biphenyls
GSDB (CDRH)
— General Surgery Devices Branch (CDRH)
CSPI
— Center for Science in the Public Interest
EMAC
— Emergency Management Assistance Compact
DPPS (CFSAN)
— Division of Plant Product Safety (CFSAN)
DVR
— Deviation Variance Report
DRUP (CDER)
— Division of Reproductive and Urologic Products (CDER)
AO
— Administrative Officer
ADRP
— Association of Donor Recruitment Professionals
JRIES
— Joint Regional Information Exchange System
CIQI
— Clinical Investigator Qualification Information
IRMC
— Information Resources Management College
ANADA
— Abbreviated New Animal Drug Application
UADE
— Unanticipated Adverse Device Event
ROC
— receiver operating characteristic curve
LMD (CBER)
— Laboratory of Method Development (CBER)
ADMIA
— Associate Director for Medical and International Affairs
CABP
— Community-Acquired Bacterial Pneumonia
OFM (OC)
— Office of Financial Management (OC)
IDE (CDRH)
— Investigational Device Exemptions Sections (CDRH)
FSPS (ORA)
— Federal-State Program Staff (ORA)
BMBL
— Biosafety in Microbiological and Biomedical Laboratories
ARDB (CDRH)
— Anesthesiology and Respiratory Devices Branch (CDRH)
ELINCS
— European List of Notified Chemical Substances
ABRA
— American Blood Resource Association
DPD (CVM)
— Division of Production Drugs (CVM)
ILINET
— Influenza-like Illness Surveillance Network
NINDS
— National Institute of Neurological Disorders and Stroke
COCB (CFSAN)
— Communication and Coordination Branch (CFSAN)
OSDB (CDRH)
— Orthopedic Spine Devices Branch (CDRH)
BDB (CDRH)
— Bacteriology Devices Branch (CDRH)
TSD (OC)
— Travel Services Division (OC)
DEPI
— Division of Ethics and Program Integrity
ORM (ORA)
— Office of Resource Management (ORA)
IMLS
— Institute of Museum and Library Services
EIND
— Electronic Investigational New Drug Application (US Food and Drug Administration)
FMB
— Financial Management Branch
DCMO (ORA)
— Division of Compliance Management and Operations (ORA)
DRV
— Daily Reference Value
DDOP (CDER)
— Division of Drug Oncology Products (CDER)
PSNI
— Pharmaceutical Society of Northern Ireland
ONDQA (CDER)
— Office of New Drug Quality Assessment (CDER)
AVEG
— AIDS Vaccine Evaluation Group
ACRA (ORA)
— Associate Commissioner for Regulatory Affairs (ORA)
CCFL
— Codex Committee on Food Labeling
DB III (CDER)
— Division of Biometrics III (CDER)
SCARP
— Supplier Corrective Action Report
EHPAS (NCTR)
— Environmental Health and Program Assurance Staff (NCTR)
IVDS
— in-vitro diagnostic devices
DIAM
— Division of Imaging and Applied Mathematics
LBVB
— Laboratory of Biochemistry and Vascular Biology
CMMI
— Center for Medicare and Medicaid Innovation
AASA
— Aging and Adult Services Administration
DC III (CDER)
— Division of Chemistry III (CDER)
FEDROOMS
— Federal Premier Lodging Program
DUPSA (CDRH)
— Division of Device User Programs and System Analysis (CDRH)
HAD
— Hospital Anxiety and Depression scale
DCTD (CDRH)
— Division of Chemistry and Toxicology Devices (CDRH)
ES
— Effect Size
LST
— LiSTing number of a device
DPC-PTR ACT
— Drug Price Competition and Patent Trade Restoration Act of 1984
RMAB (CDRH)
— Risk Management and Analysis Branch (CDRH)
CTTB (CBER)
— Cellular and Tissue Therapy Branch (CBER)
DIO (OC)
— Division of Infrastructure Operations (OC)
ARAB (OC)
— Accounting Reports and Analysis Branch (OC)
HTM
— Health Technical Memorandum
HDC
— High-Dose Chemotherapy
OIASI (OC)
— Office of International Activities and Strategic Initiatives (OC)
MEO
— Most Efficient Organization (Navy)
DETTD (CBER)
— Division of Emerging and Transfusion Transmitted Diseases (CBER)
ORPS (OC)
— Office of Real Property Services (OC)
MDCN
— Medicare Data Communication Network
ONPLDS (CFSAN)
— Office of Nutritional Products, Labeling and Dietary Supplements (CFSAN)
QU
— Quality Unit
OTS (CDER)
— Office of Translational Sciences (CDER)
BTCB (CBER)
— Blood and Tissue Compliance Branch (CBER)
DDMS (CDER)
— Division of Database Management and Services (CDER)
CBRA
— California Biomedical Research Association
FDOT (CFSAN)
— Food Defense Oversight Team (CFSAN)
OIP (OC)
— Office of International Programs (OC)
EBPDR
— electronic biological product deviation reporting
DGRND (CDRH)
— Division of General, Restorative and Neurological Devices (CDRH)
WRAMC
— Walter Reed Army Medical Center
MMRB (CFSAN)
— Microbiological Methods Research Branch (CFSAN)
DFPP (CFSAN)
— Division of Food Processing and Packaging (Chicago, Illinois) (CFSAN)
DATS
— Document Accountability and Tracking System
DRMP (CDER)
— Division of Review Management and Policy (CDER)
IAN
— International Approved Names for pharmacopoeial substances
FLQ
— Fluoroquinolone
PMF
— Public Master File
ODE II
— Office of Drug Evaluation II (CDER)
HAZOP
— HAZard and OPerability analysis
DES (OC)
— Division of Engineering Services (Immediate Office of the Commissioner)
FQHC
— Federally-Qualified Health Center
ITCB (OC)
— Information Technology Contracts Branch (OC)
FEGLI
— Federal Employees Group Life Insurance
FORM 3500
— Voluntary Reporting of Adverse Events
DDB (CDRH)
— Diagnostic Devices Branch (Center for Devices and Radiological Health)
DNP (CFSAN)
— Division of Natural Products (Center for Food Safety and Applied Nutrition)
FPBR (CFSAN)
— Food Packaging Branch (Chicago, Illinois) (CFSAN)
DVP (CBER)
— Division of Viral Products (CBER)
DCRP (CDER)
— Division of Cardiovascular and Renal Products (CDER)
SOCRA
— Society of Clinical Research Associates
FD-1932A
— FDA form for veterinary adverse drug reaction, lack of effectiveness, product defect report - voluntary
FTCA
— Federal Trade Commission Act
ATPA
— American Technology Pre-eminence Act of 1991
DP (NCTR)
— Division of Planning (National Center for Toxicological Research)
COFEPRIS
— Comisi�n Federal para la Protecci�n contra Riesgos Sanitarios (Federal Commission for the Protection Against Sanitary Risks) (Mexico)
SC (CFSAN)
— Staff College (Center for Food Safety and Applied Nutrition)
BMS
— Broadcast Media Staff
DNDLC (CDER)
— Division of New Drugs and Labeling Compliance (CDER)
DFLSC (CFSAN)
— Division of Food Labeling, Standards, and Compliance (CFSAN)
BSA
— Broad-Spectrum Antibiotic
DB V (CDER)
— Division of Biometrics V (CDER)
DTNPS (CFSAN)
— Division of Toxicology and Nutrition Product Studies (CFSAN)
CBRG
— Cancer Biomarkers Research Group
LHV (CBER)
— Laboratory of Hepatitis Viruses (CBER)
RPMB (CBER)
— Regulatory Project Management Branch (CBER)
SMDA
— Safe Medical Devices Act of 1990
DC I (CDER)
— Division of Chemistry I (CDER)
DCEPT (CBER)
— Division of Clinical Evaluation and Pharmacology/Toxicology (CBER)
ITGS (OC)
— IT Governance Staff (OC)
DBA (CBER)
— Division of Blood Applications (CBER)
DCSC (OC)
— Division of Construction and Service Contracts (OC)
SORN
— System of Records Notices
MACPAC
— Medicaid and CHIP Payment and Access Commission
ITACS
— Import Trade Auxiliary Communication System
DVRPA (CBER)
— Division of Vaccines and Related Product Applications (CBER)
ADER
— Adverse Drug Experience Report
OND (CDER)
— Office of New Drugs (CDER)
DB II (CDER)
— Division of Biometrics II (CDER)
BOS-DO (ORA)
— Boston (Massachusetts) District Office (ORA)
CDP
— Career Development Plan
MPCC
— Medical Policy Coordinating Committee
HFES
— Human Factors and Ergonomics Society's
OP 1
— Operations Team 1
MDII
— Medical Device Innovation Initiative
BAH
— Booz-Allen & Hamilton
NST
— National Support Team
MPQA
— Medical Products Quality Assurance
SMB (OC)
— Space Management Branch (OC)
ICCVAM
— Inter-agency Coordinating Committee on Validation of Alternative Methods
CSS (CDER)
— Controlled Substance Staff (CDER)
USP-NF
— United States Pharmacopeia-National Formulary
DIRM (CFSAN)
— Division of Information Resources Management (CFSAN)
IDBR
— Infectious Disease Board Review
LRA
— Local Registration Authority
CSB (ORA)
— Customer Support Branch (Office of Regulatory Affairs)
TID
— three times a day
DCP 3 (CDER)
— Division of Clinical Pharmacology 3 (CDER)
DSFM (CDRH)
— Division of Solid and Fluid Mechanics (CDRH)
DBPAP (CBER)
— Division of Bacterial, Parasitic and Allergenic Products (CBER)
DFCN (CFSAN)
— Division of Food Contact Notifications (CFSAN)
FCLAA
— Federal Cigarette Labeling and Advertising Act of 1965
ONADE (CVM)
— Office of New Animal Drug Evaluation (CVM)
C&R
— Corrections and Removals
DETTD
— Division of Emerging and Transfusion Transmitted Diseases
CIPP
— Critical Infrastructure Protection Program
DPAP (CDER)
— Division of Pulmonary and Allergy Products (CDER)
VCJD
— Variant Creutzfeldt-Jakob Disease
PELT (CFSAN)
— Product Evaluation and Labeling Team (CFSAN)
HISPC
— Health Information Security and Privacy Collaboration
LPET (CFSAN)
— Laboratory Proficiency and Evaluation Team (CFSAN)
DDM (OC)
— Division of Dockets Management (OC)
ICSR
— Individual Case Safety Report
LVBD (CBER)
— Laboratory of Vector-Borne Diseases (CBER)
NRCC
— National Response Coordination Center
JIFSAN
— Joint Institute for Food Safety and Applied Nutrition
LVCH
— Local VouCHer
OPD (OC)
— Office of Orphan Products Development (OC)
BI
— Boehringer Ingelheim
SDAB (CDER)
— Surveillance and Data Analysis Branch (CDER)
OSAS (CFSAN)
— Office of Scientific Analysis and Support (CFSAN)
CEMB (CDRH)
— Cardiac Electrophysiology and Monitoring Devices Branch (CDRH)
SB (ORA)
— Systems Branch (ORA)
LNE
— Laboratoire National de Metrologie et d'Essias (National Laboratory of Metrology and Essays)
FHB
— Food and Health Bureau
ICE
— Immigration and Customs Enforcement (Department of Homeland Security)
OGD (CDER)
— Office of Generic Drugs (CDER)
ACIL
— A national trade asociation representing independent, commerical scientific, and engineering firms (formerly the American Council of Independent Laboratories)
NEEP
— National Exercise and Evaluation Program
IMB (CDRH)
— Information Management Branch (CDRH)
CGS (ORA)
— Contract and Grants Staff (ORA)
BTR
— Blood and Tissue Registration System
OODP (CDER)
— Office of Oncology Drug Products (CDER)
NSV-DO (ORA)
— Nashville (Tennessee) District Office (ORA)
ACTB (NCTR)
— Analytical Chemical Techniques Branch (NCTR)
DDOM (CBER)
— Division of Disclosure and Oversight Management (CBER)
LF2
— Low-value Food or Food-related products, level 2 (between $200 and $500)
OPT (OC)
— Office of Pediatric Therapeutics (OC)
PVDB (CDRH)
— Peripheral Vascular Devices Branch (CDRH)
FIC
— John E. Fogarty International Center
APBI
— Association of the British Pharmaceutical Industry
DPA I
— Division of Pre-marketing Assessment I
COMAH
— Control Of Major Accident Hazards Regulation of 1999
GWQAP
— Government Wide Quality Assurance Program
SOP
— Standard Operating Procedure
OEP (CDER)
— Office of Executive Programs (CDER)
ICB (CFSAN)
— Implementation and Compliance Branch (CFSAN)
OS (CFSAN)
— Office of Seafood (CFSAN)
MSS (CDRH)
— Management Support Staff (Center for Devices and Radiological Health)
UNOS
— United Network for Organ Sharing
LDV (CBER)
— Laboratory of DNA Viruses (CBER)
MHSB (CFSAN)
— Microbial Hazards Science Branch (CFSAN)
OCTMA (CBER)
— Office of Communication, Training and Manufacturers Assistance (CBER)
DLPS (CDER)
— Division of Labeling and Program Support (CDER)
DTDNFA (CVM)
— Division of Therapeutic Drugs for Non-food Animals (CVM)
DBGNR (CFSAN)
— Division of Biotechnology and GRAS Notice Review (CFSAN)
LMV (CBER)
— Laboratory of Molecular Virology (CBER)
DCCT (CFSAN)
— Division of Color Certification and Technology (CFSAN)
GATT
— General Agreement of Tariffs and Trade
FT (OC)
— Financial Team (OC)
NBAC
— National Bioethics Advisory Commission (replaced By PCBE; Archived At GU)
NFPA
— National Food Processors Association
NONS
— Notification of New Substance Regulations 193 (EC)
OSE (CDER)
— Office of Surveillance and Epidemiology (CDER)
CPI
— Critical Path Institute
FIS
— Field Information System
TE
— Therapeutic Equivalence
IPEC
— International Pharmaceutical Excipients Council
CODB (CDRH)
— Cardiovascular and Ophthalmic Devices Branch (CDRH)
NHIC
— National Health Information Center
AEA
— Actual Expense Allowance
DPQ (CBER)
— Division of Product Quality (CBER)
RDB (CDRH)
— Radiological Devices Branch (CDRH)
NCIPC
— National Center for Injury Prevention and Control (CDC)
MPAB (OC)
— Management Programs and Analysis Branch (OC)
MDB (CFSAN)
— Methods Development Branch (CFSAN)
DTBOP (CDER)
— Division of Therapeutic Biological Oncology Products (CDER)
NRTE
— Not Ready-To-Eat
DPDFS (CFSAN)
— Division of Plant and Dairy Food Safety (CFSAN)
AND
— Abbreviated New Drug application number
KMT (OC)
— Knowledge Management Staff (OC)
CFO (OC)
— Chief Financial Officer (OC)
FMB (CDRH)
— Financial Management Branch (CDRH)
EORTC
— European Organisation for Research and Treatment of Cancer
ADR
— Adverse Drug Report
DODP (CDER)
— Division of Oncologic Drug Products (CDER)
IPPIA
— International Plasma Products Industry Association
PARN
— Problem/Action Request Notice
CI/KR
— Critical Infrastructure and Key Resources
GRN
— Generally Recognized as Safe Notification
OPA (OC)
— Office of Public Affairs (OC)
OIT (CFSAN)
— Office of Information Technology (Center for Food Safety and Applied Nutrition)
AMB (CDRH)
— Adminstrative Management Branch (CDRH)
ORADSS
— Office of Regulatory Affairs Reporting, Analysis, and Decision Support System
INAD
— Investigational New Animal Drug
DSCI (OC)
— Division of Systems, Compliance and IMPAC (OC)
CVM
— Center for Veterinary Medicine (Food & Drug Administration)
INDC
— Investigational New Drug Committee
DSST (CFSAN)
— Division of Seafood Science and Technology (CFSAN)
DPEPOS (CFSAN)
— Division of Programs and Enforcement Policy (OS) (CFSAN)
NTA
— Notice to Applicants
DBOP (CDER)
— Division of Biologic Oncology Products (CDER)
ARDB
— Anesthesiology and Respiratory Devices Branch
JMPR
— Joint FAO-WHO Meeting of Pesticide Residues
GPEA
— Government Paperwork Elimination Act
CDUS
— Clinical Data Update System (NCI)
TIND
— Treatment Investigational New Drug
WSL (CFSAN)
— Washington Seafood Laboratory (CFSAN)
DIMS (CFSAN)
— Data Information Management Staff (CFSAN)
ASB (OC)
— Accounting Services Branch (OC)
NASS
— National Agricultural Statistics Service
NPCR
— National Program of Cancer Registries
CAERST (CFSAN)
— CFSAN Adverse Event Reporting System Team
OCTEC (CDER)
— Office of Counter-terrorism and Emergency Coordination (CDER)
ACUS
— Administrative Conference of the United States
UCB
— umbilical cord blood cells
IIMB (CDRH)
— IT Infrastructure Management Branch (CDRH)
FPB (CFSAN)
— Field Programs Branch (Center for Food Safety and Applied Nutrition)
ASIA
— American Sheep Industry Association
DB IV (CDER)
— Division of Biometrics IV (CDER)
ONP (CDER)
— Office of Nonprescription Products (CDER)
MUMS (CVM)
— Office of Minor Use and Minor Species (CVM)
CFG
— Center for Functional Genomics
ICDR
— Interagency Committee on Disability Research
FNH
— Febrile Non-Hemolytic reaction
BISTI
— Biomedical Information Science and Technology Initiative
DPDD (CDER)
— Division of Pediatric Drug Development (CDER)
DMS (OC)
— Division of Management Systems (OC)
FTIM
— first time in man
HLGT
— high level group term
FD-2301
— FDA form, Transmittal of Periodic Reports and Promotional Material for New Animal Drugs
APSB (OC)
— Accounting Policy and Systems Branch (OC)
ICPEMC
— International Commission for Protection against Environmental Mutagens and Carcinogens
DGRT (NCTR)
— Division of Genetic and Reproductive Toxicology (NCTR)
ACRA
— Associate Commissioner for Regulatory Affairs (Food & Drug Administration)
ONCHIT
— Office of the National Coordinator for Health Information Technology
SAS
— Symptom Assessment Scale
SMS
— Standards Management Staff (CDRH)
CSPDB
— Circulatory Support and Prosthetic Devices Branch
DPE (CDER)
— Division of Post-marketing Development (CDER)
WNET
— Women's Network for Entrepreneurial Training
DCP 5 (CDER)
— Division of Clinical Pharmacology 5 (CDER)
EOS
— End of Study
DPIC (CFSAN)
— Division of Pesticides and Industrial Chemicals (CFSAN)
ONLDS (CFSAN)
— Office of Nutrition, Labeling and Dietary Supplements (CFSAN)
NAA
— National Aquaculture Association
LBP (CBER)
— Laboratory of Bacterial Polysaccharides (CBER)
TERMIS
— Tissue Engineering and Regenerative Medicine International Society
DRUP
— Division of Reproductive and Urologic Products
LMDQC (CBER)
— Laboratory of Methods Development and Quality Control (CBER)
CAO
— Change of Appointing Office
CCOHTA
— Canadian Coordinating Office for Health Technology Assessment
DOE B (CDRH)
— Division of Enforcement B (CDRH)
CAERS
— CFSAN (Center for Food Safety and Applied Nutrition) Adverse Event Reporting System
DCP (ORA)
— Division of Compliance Policy (ORA)
BRMS
— Biologics Regulatory Management System
NOMI
— Federation of Norwegian Pharmaceutical Manufacturers
WL
— Warning Letter (most serious Food & Drug Administration postaudit letter; demands immediate action within 15 days)
IREAS (CDRH)
— International Relations and External Affairs Staff (CDRH)
OFSDO (CFSAN)
— Office of Food Safety, Defense and Outreach (CFSAN)
DPA II (CDER)
— Division of Pre-marketing Assessment II (CDER)
EHRP
— Enterprise Human Resources and Payroll System
ORL-DO (ORA)
— ORLando District Office (Office of Regulatory Affairs)
RUG
— Resource Utilization Group
MRRA (CFSAN)
— Microbial Research and Risk Assessment Staff (CFSAN)
BPCA
— Best Pharmaceuticals for Children Act of 2002
OPF
— Official Personnel Folder
CST (CFSAN)
— Consumer Studies Team (CFSAN)
NTL
— National Testing Laboratory
CFBR
— Center for Biologics Research
NMQAAC
— National Mammography Quality Assurance Advisory Committee
EOFP
— electronic Official Personnel File
OB-GYN
— Obstetrics-Gynecology
DFPG (CFSAN)
— Division of Field Programs and Guidance (CFSAN)
FPET (CFSAN)
— Food Processing Evaluation Team (CFSAN)
DDI
— Division of Drug Information
EMEA
— European Medicines Agency (formerly European Medicines Evaluation Agency)
HERG
— human ether-a-go-go gene
CCHIT
— Certification Commission for Healthcare Information Technology
DB I (CDER)
— Division of Biometrics I (CDER)
MFC
— Model Food Code
CARTS
— CFSAN (Center for Food Safety and Applied Nutrtition) Automated Research Tracking System
CPDF
— Central Personnel Data File (OPM)
QSI
— Quality Step Increase
DBRA (NCTR)
— Division of Biometry and Risk Assessment (NCTR)
RSGEMS (CFSAN)
— Regulations and Special Government Employees Management Staff (CFSAN)
ISASS (OC)
— International Scientific Activities and Standards Staff (OC)
TFM
— Tentative Final Monograph
NPPC
— National Pork Producers Council
ISB (CDRH)
— Inspection Support Branch (CDRH)
DRGUD
— Division of Reproductive, Gastrorenal and Urology Devices (CDRH)
OIA (OC)
— Office of Internal Affairs (OC)
DRARD
— Division of Reproductive Abdominal and Radiological Devices
RFCPCS (CFAN)
— Retail Food and Cooperative Programs Coordination Staff (CFSAN)
DMQRP (CDRH)
— Division of Mammography Quality and Radiation Programs (CDRH)
EPD (CDRH)
— Electronic Product Devices Branch (CDRH)
NHRIC
— national health related items code (CDRH)
OPMAD (CDRH)
— Orthopedic Physical Medicine and Anesthesiology Devices Branch (CDRH)
EPIA
— Egg Products Inspection Act
FDAAA
— Food and Drug Administration Amendments Act
BRB
— Biometric Research Branch
IDIQ
— indefinite-delivery, indefinite-quantity [contracts]
NBDRC
— National Blood Data Resource Center
DPS (CDRH)
— Division of Post-marketing Surveillance (CDRH)
DLS
— Document Logging System
BIND
— Biological Investigational New Drug
CCVDF
— Codex Committee on Veterinary Drugs in Foods
SID
— schedule identifier number (ORA AofC code)
IVTB (CFSAN)
— In Vitro Toxicology Branch (CFSAN)
SADR
— Suspected Adverse Drug Reaction
OEEODEM (OC)
— Office of EEO and Diversity Management (OC)
DDSPC (CFSAN)
— Division of Dietary Supplement Programs and Compliance (CFSAN)
DIMS (OC)
— Division of Infrastructure Management and Services (OC)
ORO (ORA)
— Office of Regional Operations (ORA)
CISET
— Committee on International Science Engineering and Technology
BUF-DO (ORA)
— Buffalo (New York) District Office (ORA)
SGO
— Surgeon General's Office
MVT (CFSAN)
— Molecular Virology Team (CFSAN)
IPRMS (OC)
— International Planning and Resource Management Staff (OC)
GOCO
— government-owned contractor-operated
DTDFA (CVM)
— Division of Therapeutic Drugs for Food Animals (CVM)
CCID
— Coordinating Center for Infectious Diseases
MERS-TM
— Medical Event Reporting System - Transfusion Medicine
CSREES
— Cooperative State Research, Education, and Extension Services
ADRA
— Administrative Dispute Resolution Act
SDWA
— Safe Drinking Water Act (as amended in 1986)
GILS
— Government Information Locator Service
AB
— Analysis Branch
ULDB (CDRH)
— Urology and Lithotripsy Devices Branch (CDRH)
CBE
— Changes Being Effected
CES (CFSAN)
— Consumer Education Staff (Center for Food Safety and Applied Nutrition)
CCST
— Clinical Chemistry Support Team
DB VI (CDER)
— Division of Biometrics VI (CDER)
GADPTRA
— Generlc Animal Drug and Patent Term Restoration Act
NADE
— New Animal Drug Evaluation
BST
— Bovine Somatotropin
DESE
— Division of Electrical and Software Engineering
EDQM
— European Directorate for the Quality of Medicines
RESNA
— Rehabilitation Engineering and Assistive Technology Society of North America
ET (CFSAN)
— Education Team (CFSAN)
ALFB (CBER)
— Acess Litigation and FOI Branch (CBER)
DRM (OC)
— Division of Resource Management (OC)
FPLP
— Federal Premier Lodging Program
DFARS
— Drug Firm Annual Registration Status
EEPS
— Electronic Entry Processing System
DDMSS (CDER)
— Division of Data Management Services and Solutions (CDER)
BT
— Bacillus thuringiensis Berliner
DP (CDRH)
— Division of Physics (Center for Devices and Radiological Health)
DIT (NCTR)
— Division of Information Technology (National Center for Toxicological Research)
OBA
— Office of Biotechnology Activities
DSRCS (CDER)
— Division of Surveillance, Research and Communication Support (CDER)
DARPA
— Defense Advanced Research Projects Agency (DoD)
CMO
— Contract Management Organization
HAI
— Health Action International
DDPS
— Detailed Description of the Pharmacovigilance System
NDAB
— National Drugs Advisory Board
S/C
— Servings per Container
IV & V
— independent verification and validation
FICEMS
— Federal Interagency Committee on Emergency Medical Services
ADMIA (CBER)
— Associate Director for Medical and International Affairs (CBER)
DPA I (CDER)
— Division of Pre-marketing Assessment I (CDER)
ADRM
— Associate Director for Review Management
CRIX
— Clinical Research Information Exchange
OSO (OC)
— Office of Security Operations (OC)
CC/RVDF
— Codex Committee on Residues of Veterinary Drugs in Foods
MARCS
— Mission Accomplishment and Regulatory Compliance Services System (ORA)
GCPP (OC)
— Good Clinical Practice Program (OC)
FHA
— Federal Health Architecture
GRC
— Gerontology Research Center
PDE-4
— PhosphoDiEsterase-4
VISB (OC)
— Visual Information Services Branch (OC)
REG NEG
— regulatory negotiation
EHSB
— Environmental Health Services Branch
DGP (CDER)
— Division of Gastroenterology Products (CDER)
LCH (CBER)
— Laboratory of Cellular Hematology (CBER)
DSDB (CDRH)
— Diagnostic and Surgical Devices Branch (CDRH)
SAD
— Single Ascending Dose
OFAS (CFSAN)
— Office of Food Additive Safety (CFSAN)
NAHC
— National Advisory Health Council
MEFA
— Foreningen Af MEdicinfabrikanter
NDMS (CDER)
— New Drug Microbiology Staff (CDER)
PMB
— Program Management Board
CTB (CBER)
— Cell Therapies Branch (CBER)
AOPC
— Agency/Organization Program Coordinator
NMPF
— National Milk Producers Federation
CS (CVM)
— Communications Staff (CVM)
OIT (CDRH)
— Office of Information Technology (Center for Devices and Radiological Health)
TIACC
— Therapeutic Inequivalence Action Coordinating Committee
DPHB (CFSAN)
— Division of Public Health and Biostatistics (CFSAN)
SIMT
— Scientific, Internet/Intranet and Middle Tier (CFSAN)
DES (CVM)
— Division of Epidemiology and Surveillance (Center for Veterinary Medicine)
FORM 1932A
— Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report - Voluntary
NSAPE
— North American Society for Pacing and Electrophysiology
DSATOS (CFSAN)
— Division of Science and Applied Technology (OS) (CFSAN)
APEC
— Asia-Pacific Economic Cooperation Council
GPHA
— Generic Pharmaceutical Association
ITSO
— Information Technology Services Officer
IFMFS (CFSAN)
— Infant Formula and Medical Foods Staff (CFSAN)
DRP II (CDER)
— Division of Regulatory Policy II (CDER)
LRN
— Laboratory Response Network
OMP (CDER)
— Office of Medical Policy (CDER)
DFM (NCTR)
— Division of Financial Management (NCTR)
FLTCIP
— Federal Long Term Care Insurance Program
DDDP
— Division of Dermatology and Dental Products
IMB
— Irish Medicines Board
BLST (CFSAN)
— Building and Laboratory Services Team (CFSAN)
SNRI
— Serotonin-Norepinephrine Reuptake Inhibitor
HTRB (CBER)
— Human Tissue and Reproduction Branch (CBER)
DCP 2 (CDER)
— Division of Clinical Pharmacology 2 (CDER)
DIS (CDER)
— Division of Information Services (CDER)
DPAMS (CDER)
— Division of Pre-marketing Assessment III and Manufacturing Science (CDER)
ACS
— Automated Commercial System
PDQ
— physician data query information from national cancer institute
OSEL (CDRH)
— Office of Science and Engineering Laboratories (CDRH)
ASICS
— Application Specific Integrated Circuits
IPOAB
— Information Processing and Office Automation Branch
ESB
— Enterprise Systems Branch
LR2
— Low-value non-prescription Radiation-emitting products, level 2 (between $200 and $1000)
INNS
— International Neural Network Society
LCP (CDER)
— Laboratory of Clinical Pharmacology (CDER)
NDRMMP
— National Drug Residue Milk Monitoring Program
NFSS
— National Food Safety System
DS (CVM)
— Division of Surveillance (CVM)
DCP 4 (CDER)
— Division of Clinical Pharmacology 4 (CDER)
EOP2
— End-Of-Phase 2
AS (CVM)
— Administrative Staff (CVM)
DRFDD (ORA)
— Deputy Regional Food and Drug Director (ORA)
SSB
— Systems Support Branch
CAC
— Carcinogenicity Assessment Committee
ANOC
— Annual Notice of Changes
ACE
— Adverse Clinical Event
QTV
— Qualified Through Verification
ASLAP
— American Society of Laboratory Animal Practitioners
RSMB (CDRH)
— Reporting Systems Monitoring Branch (CDRH)
GLPBB (CDER)
— Good Laboratory Practices and Bioequivalence Investigations Branch (CDER)
DFRM
— Drug Facility Registration Module (FURLS)
SR
— Sustained-Release
DRP I (CDER)
— Division of Regulatory Policy I (CDER)
RPS (CDER)
— Regulatory Policy Staff (CDER)
ORD
— Office of Research and Demonstrations
DMAT (CBER)
— Division of Manufacturers Assistance and Training (CBER)
LRPDB (CDRH)
— Labeling Research and Policy Development Branch (CDRH)
OIASI
— Office of International Activities and Strategic Initiatives
EUCOMED
— EUropean COnfederation of MEDical Devices Associations
MATTB (CBER)
— Manufacturers Assistance and Technical Training Branch (CBER)
DHFS (CVM)
— Division of Human Food Safety (CVM)
HQO
— Home Quarantine Order
LEAA
— Law Enforcement Alliance of America
BIG
— Blacks In Government
NPSB (CFSAN)
— Nutritional Product Studies Branch (CFSAN)
DIS (CBER)
— Division of Inspections and Surveillance (CBER)
OCP (CDER)
— Office of Clinical Pharmacology (CDER)
BOP
— Boards Of Pharmacy
RMS (CDER)
— Review Management Staff (CDER)
TVBB (CBER)
— Tumor Vaccines and Biotechnology Branch (CBER)
DCM (CDRH)
— Division of Communications Media (CDRH)
CCRA
— Clinical Contract Research Association
RMS/BLA
— Regulatory Management System for the Biologics License Application
NVPO
— National Vaccine Program Office
GDEA
— Generic Drug Enforcement Act of 1992
CDCP
— Centers for Disease Control and Prevention
OFDCER (CFSAN)
— Office of Food Defense, Communication and Emergency Response (CFSAN)
CCOP
— Community Clinical Oncology Program
CPG
— Compliance Policy Guide
AIIS
— Analogous Industrial Injuries Scheme
LATS
— License Application Tracking System
EIS (OC)
— Ethics and Integrity Staff (OC)
ATPM
— Association of Teachers and Preventive Medicine
LCT (CFSAN)
— Labeling Compliance Team (CFSAN)
NE-FO (ORA)
— Regional Field Office, Northeast Region
ELIPS
— Electronic Labeling Information Processing System
ITTT
— Information Technology Training Team
RADAR
— Radio Detecting and Ranging
HITSP
— Health Information Technology Standards Panel
GCC
— Government Coordinating Council of the Food and Agriculture Sector
NME
— New Molecular Entity
FPVST (OC)
— Facilities Planning and Voice Services Team (OC)
CSPDB (CDRH)
— Circulatory Support and Prosthetic Devices Branch (CDRH)
DPEB
— Division of Planning, Evaluation, and Budget
FARM
— Food Additives Regulatory Management System
LMDCI (CBER)
— Laboratory of Mycobacterial Diseases and Cellular Immunology (CBER)
BIRA
— British Institute of Regulatory Affairs
VEDB (CDRH)
— Vitreal and Extraocular Devices Branch (CDRH)
CEDR
— Comprehensive Epidemiologic Data Resource (U.S. Department of Energy)
FSIS
— Food Safety and Inspection Service
COMSTAT
— COMpliance STATus Information System
OIT (CVM)
— Office of Information Technology (Center for Veterinary Medicine)
AE
— Approvable, but not yet approved
PTCC
— Pharmacology and Toxicology Coordinating Committee
DRAT (CFSAN)
— Division of Research and Applied Technology (CFSAN)
CSG
— Counterterrorism Security Group
OTRR (CBER)
— Office of Therapeutics Research and Review (CBER)
ALL
— Adult Acute Lymphocytic Leukemia
CGMPR
— Current Good Manufacturing Practices Regulations
SUPAC-MR
— scale-up and postapproval changes--modified release
ARL (ORA)
— Arkansas Regional Laboratory (ORA)
SDWIS
— Safe Drinking Water Information System
WNV
— West Nile Virus
DNRD
— Division of Nonprescription Regulation Development
DC II (CDER)
— Division of Chemistry II (CDER)
NOOH
— Notice Offering an Opportunity for a Hearing
ACTIS
— AIDS Clinical Trials Information Service
VCTB (CBER)
— Vaccine Clinical Trials Branch (CBER)
OND
— Office of New Drugs
SUDS
— Single-Use Devices
NNC
— National Notification Center
FLSS (CFSAN)
— Food Labeling and Standards Staff (CFSAN)
CDDI
— Collaboration for Drug Development Improvement
MSAB (CFSAN)
— Manufacturing and Storage Adulteration Branch (CFSAN)
SSRCR
— Suggested State Regulations for Control of Radiation
DCMS (CDRH)
— Division of Chemistry and Material Science (CDRH)
COS (CFSAN)
— Cosmetics Staff (CFSAN)
DIO (CBER)
— Division of Information Operations (CBER)
CCFICS
— Codex Committee on Food Import and Export Certification and Inspection Systems
NCBDDD
— National Center on Birth Defects and Developmental Disabilities
CONSER
— Cooperative Online Serials
ADAM
— Analysis Dataset Model
EOS (ORA)
— Executive Operations Staff (ORA)
AED
— anti-epileptic drug
FMLA
— Family and Medical Leave Act of 1993
DBEPA (CBER)
— Division of Blood Establishment and Product Applications (CBER)
DAIDS
— Division of AIDS (NIAID)
VSS (NCTR)
— Veterinary Services Staff (NCTR)
SECT 406B
— FDA Modernization Act section dealing with getting feedback from stakeholders
OSD-HD
— Office of the Secretary of Defense for Homeland Defense
LECC
— Law Enforcement Coordination Committee
OIT (NCTR)
— Office of Information Technology (National Center for Toxicological Research)
DPAF
— Division of Planning, Analysis, and Finance
ESS (NCTR)
— Executive Secretariat Staff (NCTR)
PAFA
— Priority-Based Assessment of Food Additives
IMB (CDER)
— Interface Management Branch (CDER)
SISCF/SIFCF
— Survey of Inmates of State and Federal Correctional Facilities
IBB (CFSAN)
— Instrumentation and Biophysics Branch (CFSAN)
ERSB (CFSAN)
— Emergency Response and Surveillance Branch (CFSAN)
DMB (CFSAN)
— Division of Molecular Biology (CFSAN)
FAAN
— Food Allergy and Anaphylaxis Network
CTX
— Clinical Trials Exemption
ISBT
— International Society of Blood Transfusion
NWK-DO (ORA)
— Newark District Office (ORA)
ORPSS (CFSAN)
— Office of Regulations, Policy and Social Sciences (CFSAN)
IRS (OC)
— International Relations Staff (OC)
GPRA
— Government Performance Results Act of 1993
HPAA
— Health Policy and Administration
DCT (CDER)
— Division of Counter-terrorism (CDER)
DDOM
— Division of Disclosure and Oversight Management
CCPR
— Codex Committee on Pesticide Residues
406B
— Section of the FDA Modernization Act dealing with getting feedback from our stakeholders
BIMS
— Biologic IND (Investigational New Drug) Management System
FPVST
— Facilities Planning and Voice Services Team
IOM
— Investigation Operations Manual
GRDB (CDRH)
— Gastroenterology and Renal Devices Branch (CDRH)
NBCS
— National Biomedical Computer System
DCIA
— Debt Collection Act of 1996
ORO
— Office of Regional Operations
LMS
— LABORATORY MANAGEMENT SYSTEM
DVA (CFSAN)
— Division of Virulence Assessment (CFSAN)
BWM
— basic workload measurement
ESS (CBER)
— Executive Secretariat Team (CBER)
BPB (CBER)
— Blood and Plasma Branch (CBER)
DIDP (CBER)
— Division of Information Disclosure Policy (CDER)
APR
— Annual Product Review
CPS
— Compendium of Pharmaceuticals and Specialties
NCER
— Non-Conformance Escalation Report
DC (NCTR)
— Division of Chemistry (NCTR)
RFPT (CFSAN)
— Retail Food Protection Team (CFSAN)
DAVP (CDER)
— Division of Anti-viral Products (CDER)
SIB (CDRH)
— Special Investigations Branch (CDRH)
NCFST
— National Center for Food Safety & Technology
OSB (CDRH)
— Office of Surveillance and Biometrics (CDRH)
DVPS (CVM)
— Division of Veterinary Product Safety
ARNET
— Acquisition Reform Network
SCRAG
— Senior Civilian Representative of the Attorney General, Department of Homeland Security
MT (CFSAN)
— Medical Team (CFSAN)
QOS
— Quality Overall Summary
V/V
— Verification/Validation
SITP 5A8(OC)
— Strategic IT Programs (OC)
BDSS
— Biologics Decision Support System
SMPS (CDRH)
— Standards Management Program Staff (CDRH)
VOAD
— Volunteer Organizations Active in a Disaster
CM
— Committee Meeting
DDRE
— Division of Drug Risk Evaluation
DEPI (CDER)
— Division of Epidemiology (CDER)
PHTN
— Public Health Training Network
EEO (NCTR)
— Equal Employment Opportunity Staff (NCTR)
DFPST (CFSAN)
— Division of Food Processing Science and Technology (CFSAN)
R&W
— Recreation and Welfare
AMT
— Asset Management Team
SPA
— Special Protocol Assessment
BACPAC
— Bulk ACtivities Post-Approval Changes
OTCOM (CDER)
— Office of Training and Communications (CDER)
UKCCR
— United Kingdom Coordinating Committee on Cancer Research
ECRS (CFSAN)
— Emergency Coordination and Response Staff (CFSAN)
DCC (OC)
— Division of Customer Care (OC)
NCAB
— National Cancer Advisory Board
RIAS
— Regulatory Impact Analysis Statement
DER
— Drug Experience Report
DPP (CDER)
— Division of Psychiatry Products (CDER)
DMB (CDER)
— Division of Management and Budget (CDER)
ACB
— Accreditation and Certification Branch
TGA
— Therapeutic Goods Administration (Australia)
TPDS
— Training and Professional Development Staff
HCDB (CDRH)
— Hematology and Cytology Devices Branch (CDRH)
FPA
— Food Products Association
DCD (CDRH)
— Division of Cardiovascular Devices (CDRH)
SDCID
— Study Data Common Issues Document
DMSO
— chloroform/2-propanol/dimethylsulfoxide
EMBS
— Engineering in Medicine and Biology Society (IEEE)
AMT (OC)
— Asset Management Team (OC)
SDE
— State Designated Entity
TDDB (CDRH)
— Television Design and Development Branch (CDRH)
FRDTS
— Federal Register Document Tracking System
CENELEC
— Comite Europeen de Normalisation Electrotechnique (European Committee for Electrotechnical Standardization)
MGB (CFSAN)
— Molecular Genetics Branch (CFSAN)
OST (CFSAN)
— Office Services Team (CFSAN)
IPRO
— Independent Pharmaceutical Research Organization
ICIB (CDRH)
— Intraocular and Corneal Implants Branch (CDRH)
AHI
— Animal Health Institute
ACWA
— Administrative Careers With America
PDLB (CDRH)
— Pacing, Defibrillator and Leads Branch (CDRH)
HPO
— High Performance Organization
LIR (CBER)
— Laboratory of Immunoregulation (CBER)
BSE
— bovine spongiform encephalopathy (mad cow disease)
VDB (CDRH)
— Virology Devices Branch (CDRH)
HP
— High Potency
LM
— Listeria monocytogenes
ITATMT (OC)
— IT Asset Tracking and Management Team (OC)
DVS (CBER)
— Division of Veterinary Services (CBER)
DBE (CDER)
— Division of Bioequivalence (CDER)
CM
— Case Management
ABLES
— Adult Blood Level Epidemiology & Surveillance
PAER
— Preliminary Adverse Event Report
ATS (CDER)
— Applied Technologies Staff (CDER)
EES
— Establishment Evaluation System
DEOD (CDRH)
— Dental, Ear, Nose, Throat and Ophthalmic Devices Branch (CDRH)
CDRS (CFSAN)
— Case Development and Recall Staff (CFSAN)
IIMG
— Interagency Incident Management Group
OFACS
— Office of Facilities, Acquisitions and Central Services
AFC
— Adult Foster Care
OPDFB (CFSAN)
— Office of Plants, Dairy Foods and Beverages (CFSAN)
CBSC
— Cord Blood Stem Cells
OD (CDER)
— Office of the Center Director (CDER)
OSS (OC)
— Office of Shared Services (OC)
NRB
— Noninstitutional Review Board
LR (CBER)
— Laboratory of Retroviruses (CBER)
FEDGLOBE
— Gay, Lesbian, Bisexual, Transgender Employees of the Federal Government
CEN
— Comite Europeen de Normalisation (European Committee for Standardization)
DHS
— Department of Homeland Security (U.S.)
COPTRG
— Community Oncology and Prevention Trials Research Group (NCI)
SPIE
— International Society for Optical Engineering
OSB (CFSAN)
— Office Services Branch (CFSAN)
DRMO (CDRH)
— Division of Risk Management Operations (CDRH)
ANA
— Abbreviated New Animal drug number
GMA
— Grocery Manufacturers Association's
GRAS/E
— Generally Recognized As Safe and Effective
CDDTB (CBER)
— Career Development and Directed Training Branch (CBER)
TAS (NCTR)
— Technology Advancement Staff (NCTR)
C3I
— communications, command, control, and intelligence
HCTERS
— Human Cell and Tissue Establishment Registration System
OFFAS (OC)
— Office of Field Financial and Acquisitions Services (OC)
BCE
— Beneficial Clinical Event
MTOS (CFSAN)
— Muirkirk Technical Operations Staff (CFSAN)
WOC II
— Woodmont Office Complex II (South)
BCP
— Bureau of Consumer Protection
PDS (CDER)
— Project Development Staff (CDER)
PTC
— Parklawn Training Center
NSE
— Not Substantially Equivalent
OSCI (CFSAN)
— Office of Science (CFSAN)
CARS
— Compliance Achievement Reporting System
DPA II
— Division of Pre-marketing Assessment II
CSAT
— Center for Substance Abuse Treatment (SAMHSA)
NSRT
— Nutrition Science Review Team
DPEM
— Division of Planning, Evaluation, and Management
IB (ORA)
— International Branch (ORA)
OB
— Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)
DRB
— Devices Review Branch
DRM (CDER)
— Division of Records Management (CDER)
MSTD
— Materials Science and Technology Department
DCP 1 (CDER)
— Division of Clinical Pharmacology 1 (CDER)
DMS (CFSAN)
— Division of Microbiological Studies (CFSAN)
CHII
— Consolidated Health Informatics Initiative
SN/AEMS
— Special Nutritional Adverse Events Monitoring System
DTP (CDER)
— Division of Therapeutic Proteins (CDER)
DEC (CFSAN)
— Division of Education and Communication (CFSAN)
CHI
— Consolidated Health Initiative
MMRB
— Microbiological Methods Research Branch
RSB (CDER)
— Review Support Branch (CDER)
FPIF
— Finnish Pharmaceutical Industry Association
OCI
— Office of Criminal Investigations (FDA)
OP 4
— Operations Team 4
RDI
— Reference Daily Intake
CP
— Compliance Program
ASPER
— Assistant Secretary for Personnel
BEQ
— bioequivalence
IFAD
— International Food Additives Database
CERCLIS
— Comprehensive Environmental Response, Compensation and Liability Information System (EPA)
ICB (CDRH)
— Inspection and Compliance Branch (CDRH)
LPD (CBER)
— Laboratory of Plasma Derivatives (CBER)
ECRI
— Emergency Care Research Institute (no longer uses name initials only)
ADSA
— Aging and Disability Services Administration
LH (CBER)
— Laboratory of Hemostasis (CBER)
RFDD
— Regional Food and Drug Director
IQA
— Institute of Quality Assurance (UK)
ASD(HD)
— Assistant Secretary of Defense for Homeland Defense
DRISK (CDER)
— Divison of Risk Management (CDER)
REE
— Research, Education, and Economics
LBPUA (CBER)
— Laboratory of Bacterial, Parasitic and Unconventional Agents (CBER)
OCO (CFSAN)
— Office of Constituent Operations (CFSAN)
NEFLE
— National Exchange for Food Labeling Education
OPPL
— Office of Policy, Planning, and Legislation
OMS (CFSAN)
— Office of Management Systems (CFSAN)
IPCB (CDER)
— Investigations and Preapproval Compliance Branch (CDER)
AGA
— Association of Government Accounts
RES
— Residence
DSM
— Data Standards Manual
LASA
— Linear Analog Self-Assessment measure
FGIS
— Comisión Federal para la Protección contra Riesgos Sanitarios (Federal Commission for the Protection Against Sanitary Risks) (Mexico)
OPFIT (NCTR)
— Office of Planning, Finance and Information Technology (NCTR)
CRIS
— Clinical Research Information System (NIH)
DSPTP (CDER)
— Division of Special Pathogen and Transplant Products (CDER)
IAVG
— Interagency Vaccine Group
ABE
— Adverse Biologic Experience
BAC
— Billing Agency Code
BACON
— Bacterial CONtamination
DBCP (CBER)
— Division of Blood Collection and Processing (CBER)
OTCDHFB (CDER)
— OTC Drugs and Health Fraud Branch (CDER)
INFARMED
— Instituto Nactional da FARMaciae e do MEDicamento (Portugal)
DCGT (CBER)
— Division of Cell and Gene Therapies (CBER)
DSDB
— Diagnostic and Surgical Devices Branch
NGFA
— National Grain and Feed Association
CFOI
— Census of Fatal Occupational Injuries
NVSS
— National Vital Statistics System
DPR (CFSAN)
— Division of Petition Review (CFSAN)
MMSB (CFSAN)
— Molecular Methods and Subtyping Branch (CFSAN)
EREA
— Export Reform and Enhancement Act of 1996
DMA (CDER)
— Division of Monoclonal Antibodies (CDER)
MSQA
— Mammography Quality Standards Act of 1992
OCTGT (CBER)
— Office of Cellular, Tissue and Gene Therapies (CBER)
DCP (NCTR)
— Division of Contracts and Procurement (NCTR)
BPB
— Blood and Plasma Branch
DSMICA (CDRH)
— Division of Small Manufacturers, International and Consumer Assistance (CDRH)
DC (CVM)
— Division of Compliance (CVM)
NOAA
— National Oceanographic and Atmospheric Administration (U.S.)
ASHRAE
— American Society of Heating, Refrigeration & Air Conditioning Engineers
HTLV-III
— human lymphotropic virus, type III (AIDS agent, HIV)
NCWM
— National Conference on Weights and Measures
CUVP
— Committee for Veterinary Medicinal Products (EMEA)
LPT (CFSAN)
— Liaison and Policy Team (CFSAN)
NDIRS (CFSAN)
— New Dietary Ingredients Review Staff (CFSAN)
DMAT
— Division of Manufacturers Assistance and Training
MFRPS
— Manufactured Food Regulatory Program Standards
RAA
— Research Across America (various locations)
OCTMA
— Office of Communication, Training and Manufacturers Assistance
BSB (CFSAN)
— Biotechnology Studies Branch (Chicago, Illinois) (CFSAN)
NARMS
— National Antimicrobial Resistance Monitoring System
FEHBP
— Federal Employees Health Benefits Program
SRS (CDER)
— Science and Research Staff (CDER)
DPFRM
— Division of Planning and Financial Resources Management
DNRD (CDER)
— Division of Nonprescription Regulation Development (CDER)
BSC
— Blood Safety Committee
CPSA
— Consumer Product Safety Act
EEO (CFSAN)
— Equal Employment Opportunity Office (CFSAN)
ACEC
— Autism Centers of Excellence Program (NIH)
NIDR
— National Institute of Dental Research (see NIDCR)
DM (NCTR)
— Division of Microbiology (NCTR)
DE (CBER)
— Division of Epidemiology (CBER)
NPRM
— Notice of Proposed Rulemaking
NTF
— National Turkey Federation
CDR
— Central Document Room
IAST (CFSAN)
— International Activities Staff (CFSAN)
OIRA
— Office of Information & Regulatory Affairs
NOAE
— no observed adverse effect
AICRC
— Association of Independent Clinical Research Contractors
DDRE (CDER)
— Division of Drug Risk Evaluation (CDER)
FES (OC)
— Financial Enterprise Solutions (OC)
BMIS
— Bioresearch Monitoring Information System
VATS
— Viral Activation Transfusion Study
HBOC
— hemoblogin-based oxygen carrier
RPB (CDRH)
— Radiation Programs Branch (CDRH)
PARS (CDER)
— Program Activities Review Staff (CDER)
RCT (CFSAN)
— Recall Team (CFSAN)
TBP
— Therapeutic Biologic Product
LERN
— Library Electronic Reference Network
DRR (NCTR)
— Deputy Director for Research (NCTR)
CDTL
— Cross Discipline Team Leader
VMAC
— Veterinary Medicine Advisory Committee
NCID
— National Center for Infectious Diseases (CDC)
DMD (CDRH)
— Division of Microbiology Devices (CDRH)
CACTIS
— Center ADP/TC Computer Tracking and Inventory System
DMO (CFSAN)
— Division of Management Operations (CFSAN)
FORCG
— Foodborne Outbreak Response Coordinating Group
SUPEC
— Scale-Up and Post-Approval Changes
ADRA
— Associate Director of Regulatory Affairs
HSIN
— Homeland Security Information Network
DHT (CBER)
— Division of Human Tissues (CBER)
NASAR
— National Association of Search and Rescue
OVI
— Organic Volatile Impurity
CASPER
— Center Automated System Process Exchange and Reporting
BDPA
— Bureau of Drug Policy and Administration (China)
CPFP
— Cancer Prevention Fellowship Program (NCI)
SMS (CFSAN)
— Safety Management Staff (CFSAN)
PPIA
— Poultry Products Inspection Act
DVS (NCTR)
— Division of Veterinary Services (NCTR)
SSB (CDRH)
— Systems Support Branch (CDRH)
CBCTN
— Community-Based Clinical Trials Network
HARTS
— Hoechst Adverse Reaction Terminology System
DBT (NCTR)
— Division of Biochemical Toxicology (NCTR)
JAN
— Japanese Adopted Names
DRAT
— Division of Research and Applied Technology
CERTS
— Centers for Education and Research on Therapeutics (DHHS)
DID (CBER)
— Division of Information Development (CBER)
BRMAC
— Biological Response Modifiers Advisory Committee
OTR (CDER)
— Office of Testing and Research (CDER)
NCPHI
— National Center for Public Health Informatics (CDC)
FWP
— Federal Women's Program
TOR
— Threshold of Regulation
NAD
— NED Animal Drug number
DTBE
— Division of Tuberculosis Elimination
EB (CDRH)
— Epidemiology Branch (CDRH)
SNIP
— Syndicat National de l'Industrie Pharmaceutique
OMP (OC)
— Office of Management Programs (OC)
SBREFA
— Small Business Regulatory Enforcement Fairness Act
ALFB
— Access Litigation and FOI (Freedom Of Information) Branch
NHF
— National Hemophilia Foundation
JLCS (OC)
— Jefferson Laboratory Complex Staff (OC)
MSI
— Magnetic Source Imaging
DFOI (OC)
— Division of Freedom of Information (OC)
NAGC
— National Association of Government Communicators
EIDE
— Electronic Investigational Device Exemption
ANRC
— American National Red Cross
MAS CELL
— manipulated autologous structural cell
FACD
— Food Additives and Chemicals Division
USAMRIID
— U.S. Army Medical Research Institute for Infectious Diseases
ITC
— International Trade Commission
CSI
— Consumer Safety Inspector
IBE
— individual bioequivalence
ESB (ORA)
— Enterprise Systems Branch (ORA)
SGEMT (CFSAN)
— Special Government Employees Management Team (CFSAN)
ADI
— Acceptable Daily Intake (National Academy of Science)
WOC I
— Woodmont Office Complex I (North)
BPWG
— Business Process Working Group
NICCL
— National Incident Communications Conference Line
CSA
— Clinical Study Agreement
DCC (CFSAN)
— Division of Cosmetics and Compliance (CFSAN)
UCUM
— Unified Codes for Units of Measure (Regenstrief Institute)
AIP
— APHIS (Animal and Plant Health Inspection Service) Integrated Planning
SSE
— Summary of Safety and Effectiveness
DEOD
— Dental, Ear, Nose, Throat, and Ophthalmic Devices Branch
OPL (OC)
— Office of Planning (OC)
RCS (CFSAN)
— Regulations Coordination Staff (CFSAN)
OHSC
— OCCUPATIONAL HEALTH and SAFETY CENTRE
IOTF
— Interagency Oncology Task Force
RTL (NCTR)
— Reproductive Toxicology Laboratory (NCTR)
DQRS
— Drug Quality Reporting System
CI
— Clinical Investigator
PDUFA
— Prescription Drug User Fee Act of 1992
GAAP
— Greater Access to Affordable Pharmaceuticals Act of 2003
B&F
— Budget and Finance
ECT (CFSAN)
— Economics Team (CFSAN)
NVTB (CFSAN)
— Neurotoxicological and In Vitro Toxicology Branch (CFSAN)
FDAGLOBE
— Gay, Lesbian, Bisexual, Transgender Employees of the Federal Government within FDA