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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
CF
— Cystic Fibrosis
LAN
— Local Area Network
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
POB (CBER)
— Program Operations Branch (CBER)
PPTA
— Plasma Protein Therapeutics Association
PPC
— Production and Process Controls
IMP
— Investigational Medicinal Product
PPWMB
— Program Planning and Workforce Management Branch
COPD
— Chronic Obstructive Pulmonary Disease
YTD
— Year To Date
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
Q & A
— questions and answers
CHF
— Congestive Heart Failure
AF
— Atrial Fibrillation
ECG
— Electrocardiogram
OEM
— Original Equipment Manufacturer (usually in reference to car parts)
ASAP
— As Soon As Possible (pronounced AY-sap)
CABG
— Coronary Artery Bypass Graft
FLSA
— Fair Labor Standards Act
DAT
— Diet As Tolerated
PNS (CDRH)
— Premarket Notification Section (CDRH)
R & W
— recreation and welfare
RFID
— Radio Frequency Identification
PMS (OC)
— Print Media Staff (OC)
FTP
— File Transfer Protocol
ANSI
— American National Standards Institute, Inc.
PNC (ORA)
— Prior Notice Center (ORA)
PMSB (CDER)
— Program Management Services Branch (Center for Drug Evaluation and Research)
M&IE
— Meals and Incidental Expenses
PMSB (CBER)
— Program Management Services Branch (Center for Biologics Evaluation and Research)
LASER
— Light Amplification By Stimulated Emission Of Radiation (cf. Maser)
R & D
— research and development
PNS
— Premarket Notification Section
CSR
— Customer Service Representative
IT
— Information Technology
PMSB
— Pharmaceutical and Medical Safety Bureau (Japan)
PMS (CDRH)
— Program Management Staff (CDRH)
UK
— United Kingdom of Great Britain and Northern Ireland
HIPAA
— Health Insurance Portability and Accountability Act of 1996
POC
— Point Of Contact
CPP
— Certificate of Pharmaceutical Product
PETG
— Polyethylene Terephthalate Glycol
PMSC
— Pre-Market Surveillance and Compliance
EPA
— Environmental Protection Agency (US)
COB
— close of business (End of duty day)
CVA
— Cerebrovascular Accident
ATM
— Automatic Teller Machine
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)
PIC/S
— Pharmaceutical Inspection Co-operation Scheme
CT
— Computed Tomography
OCC (OC)
— Office of the Chief Counsel (OC)
FIFO
— First In, First Out
PNIG
— Patient Narrative Information Guide
P & PC
— production and process controls
PDF
— Portable Document Format (created by Adobe Acrobat)
UNESCO
— United Nations Educational, Scientific and Cultural Organization
BA/BE
— Bio-Availability/Bio-Equivalence
PGB
— Policy Guidance Branch
ANOVA
— Analysis of Variance (statistics)
PMN#
— Pre-Market Notification number of a device
SSN
— Social Security Number
PMC
— Post-Marketing Commitment
PHSA
— Public Health Service Act of 1944
PLI
— Pre-License Inspection
PMA#
— Pre-Market Approval device number
BPM
— Beats Per Minute
QC
— Quality Control
GUI
— Graphical User Interface (goo-ey)
PLF
— Product Licensing Framework (Canada)
PIP
— Plant-Incorporated Protectant
MOU
— Memorandum of Understanding (an MOU between Food & Drug Administratin and a regulatory agency in another country allows mutual recognition of inspections)
R&D
— Research & Development
RSV
— Respiratory Syncytial Virus
PIB
— Program Inspection Branch
PMCC
— Project Management Coordinating Committee
FAQ
— Frequently Asked Questions (sometimes Pronounced Fak)
RFP
— Request For Proposal
PMHS
— Pediatric and Maternal Health Staff
E-CRF
— electronic case report form
ISP
— Internet Service Provider
SD
— Standard Deviation
CY
— Calendar Year
FEMA
— Federal Emergency Management Agency
MRB
— Material Review Board
PLAS
— Prior Label Approval System
PHN
— Population, Health, and Nutrition Center
CBC
— Complete Blood Count
TQM
— Total Quality Management
EDI
— Electronic Data Interchange
DAARP (CDER)
— Division of Anesthesia, Analgesia, and Rheumatology Products (CDER)
PKLN
— ParkLawn Building
G-MED (LNE)
— Groupfor Medical Device Assessment (Laboratoire National de Metrologie et d'Essias)
PIFSI
— Produce and Imported Foods Safety Initiative
PSUR
— Periodic Safety Update Report
A-VO2
— arteriovenous oxygen
ASTM
— American Society for Testing and Materials (Philadelphia, Pennsylvania)
XDR-TB
— Extensively Drug-Resistant Tuberculosis
B&F (CVM)
— Budget and Finance Team (CVM)
CEO
— Chief Executive Officer
OBP (CDER)
— Office of Biotechnology Products (CDER)
SACX
— Secretary's Advisory Committee on Xenotransplantation
WBS
— Work Breakdown Structure
ACTH
— Adrenocorticotropic Hormone
NCR
— Non-Conformance Report
MSDS
— Material Safety Data Sheets
MRI
— Magnetic Resonance Imaging
SME
— Subject Matter Expert
FX
— Fracture
TBD
— To Be Determined
IV
— Intravenous
DAAP (CDER)
— Division of Anesthesia and Analgesia Products (CDER)
SMTP
— Simple Mail Transfer Protocol
VPN
— Virtual Private Network (ATM)
D0AF (CDRH)
— Division of Planning, Analysis and Finance (CDRH)
QIS-P
— Quality Information Summary - Pharmaceuticals
ADH
— Antidiuretic Hormone
IPO
— Initial Public Offering
FY
— Fiscal Year
EEO
— Equal Employment Opportunity
HTTP
— Hypertext Transfer Protocol
ARPA
— Advanced Research Projects Agency (made early internet)
OTC
— Over The Counter (medications not requiring a prescription)
C-CDA
— Consolidated - Clinical Document Architecture
ASME
— American Society of Mechanical Engineers
P&PC
— Production and Process Control
GI
— Gastrointestinal
FYI
— For Your Information
E-ARCH
— Extended Adult Residential Care Home
M2 EWG
— ICH M2 Expert Working Group
SOW
— Statement Of Work
DOD
— United States Department of Defense
CV
— Curriculum Vitae
UCBU
— Umbilical Cord Blood Unit
USDA
— United States Department of Agriculture
WWW
— World Wide Web
DNR
— Do Not Resuscitate
QA
— Center for Quality Assurance in International Education
CAB (OC)
— Computer Applications Branch (OC)
DIC
— disseminated intravascular coagulation
TAB (OC)
— Travel Audit Branch (OC)
CPI
— Consumer Price Index
RACT (CFSAN)
— Risk Assessment Coordination Team (CFSAN)
WAT (CFSAN)
— Worklife Analysis Team (CFSAN)
QAS (CBER)
— Quality Assurance Staff (CBER)
ADP
— Automated Data Processing
DVM
— Doctor of Veterinary Medicine
DAC (CFSAN)
— Division of of Analytical Chemistry (CFSAN)
ANZFA
— Australia New Zealand Food Authority (now Food Standards Australia New Zealand)
COBRA
— Consolidated Omnibus Budget Reconciliation Act of 1985
NGO
— Non-governmental organization. (Red Cross/Crescent, Doctors without Borders, etc.)
DADS (CDER)
— Division of Applications Development and Services (CDER)
IAMFES
— International Association of Milk, Food and Environmental Sanitarians
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.
DHR
— Device History Record
ᄃ
— Section; shorthand symbol used to designate a section in a legal document
M4 EWG
— ICH M4 Expert Working Group
NCCLS
— National Committee for Clinical Laboratory Standards
DX
— Diagnosis
℮
— estimated
DA (OC)
— Division of Accounting (OC)
FACS (CFSAN)
— Food Advisory Committee Staff (CFSAN)
AABB
— American Association of Blood Banks
NSN
— National Stock Number
DAS (CFSAN)
— Division of Administrative Services Management (CFSAN)
OBRR (CBER)
— Office of Blood Research and Review (CBER)
OCAC (CFSAN)
— Office of Cosmetics and Colors (CFSAN)
BARS (CDER)
— Business Analysis and Reporting Staff (CDER)
VBPV
— Vegetative Bacteria, Protozoa, and Viruses
RFI
— Request For Information. Sales department shorthand. Special priority when use in conjunction with RFN (see below).
IAB (CDRH)
— Information and Analysis Branch (CDRH)
LOV
— List Of Values
DAFM (CVM)
— Division of Animal and Food Microbiology (CVM)
FARMINDU STRIA
— Association of Italian Pharmaceutical Manufacturers
FBI
— Federal Bureau of Investigation
HAB (CFSAN)
— Hazard Assessment Branch (CFSAN)
IAB (ORA)
— Infrastructure Applications Branch (ORA)
CVP
— Central Venous Pressure
RAM
— random-access memory
ᄃᄃ
— Sections; shorthand symbol used to designate sections in a legal document
QAT (CBER)
— Quality Assurance Team (CBER)
DAEA II
— Division of Adverse Event Analysis 2
MACS (CBER)
— Manufacturers Assistance and Communications Staff (CBER)
CV
— Cardiovascular
OCD (CVM)
— Office of the Center Director (CVM)
DARRTS
— Document Archiving, Reporting, and Regulatory Tracking System
RSS (CDER)
— Regulatory Support Staff (CDER)
OCD (CDRH)
— Office of the Center Director (CDRH)
EAB (CFSAN)
— Exposure Assessment Branch (CFSAN)
J/D
— Judgment for the Defendant
OAGS (OC)
— Officeof Acquisitions and Grants Services (OC)
LANGUAL
— Langua Alimentaria (Language of Foods)
FACTS@FDA
— system for electronically communicating approved drug labeling and for disseminating prescribing information
IAS (OC)
— International Agreements Staff (OC)
CBO
— Congressional Budget Office
OC (CDRH)
— Office of Compliance (CDRH)
TAB (CDRH)
— Technical Assistance Branch (CDRH)
DAS (NCTR)
— Division of Administrative Services (NCTR)
QAU (CFSAN)
— Quality Assurance Unit (CFSAN)
CMC
— Chemical Manufacturing Control
DBA
— Doing Business As
OC (CFSAN)
— Office of Compliance (CFSAN)
DSS
— Decision Support System
ISDN
— Integrated Services Digital Network
OCBQ (CBER)
— Office of Compliance and Biologics Quality (CBER)
EAS (CDER)
— Enterprise Architecture Staff (CDER)
DAE (OC)
— Division of Applied Engineering (OC)
DAGID (CDRH)
— Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (CDRH)
CNS
— Central Nervous System
BBS
— Bulletin Board System
PAIS (ORA)
— Public Affairs and Information Staff (ORA)
OC (CDER)
— Office of Compliance (CDER)
T/PT
— Traceability/Product Tracing
OB (CDER)
— Office of Biostatistics (CDER)
OBQI/M
— Outcome-Based Quality Improvement/Monitoring
S/NDS
— Supplemental / New Drug Submission
CIO
— Chief Information Officer
FAEMS
— Foods Adverse Event Monitoring System
RRSS (CDER)
— Regulatory Review Support Staff (CDER)
OAP (CDER)
— Office of Antimicrobial Products (CDER)
KG
— Kilogram
AMA
— American Medical Association
MAB (CFSAN)
— Methods Application Branch (CFSAN)
NAET (CFSAN)
— Nutrition Assessment and Evaluation Team (CFSAN)
DAIOP (CDER)
— Division of Anti-infective and Ophthalmology Products (CDER)
DAF (CVM)
— Division of Animal Feeds (CVM)
OBFP (OC)
— Office of Budget Formulation and Presentation (OC)
OCD (CFSAN)
— Office of the Center Director (CFSAN)
OARSA (CFSAN)
— Office of Applied Research and Safety Assessment (CFSAN)
FR
— Federal Register
AARP
— American Association of Retired Persons
DAR (CVM)
— Division of Animal Research (CVM)
OBPS (CDER)
— Office of Business Process Support (CDER)
WAN
— Wide Area Network
DAPR (CDER)
— Division of Applied Pharmacology Research (CDER)
MAB (CDER)
— Management Analysis Branch (CDER)
OBES (OC)
— Office of Business Enterprise Solutions (OC)
PAB (CFSAN)
— Product Adulteration Branch (CFSAN)
MACMIS
— Marketing, Advertising and Communication Management Information System
ASD
— Atrial Septal Defect
LOA
— Letter Of Agreement
HMO
— Health Maintenance Organization
EANDA
— Electronic Abbreviated New Drug Application
DHCP
— Dynamic Host Configuration Protocol
PC
— Personal computer (host)
RDBMS
— Relational Database Management System
AAR
— After Action Review
CFR
— Code of Federal Regulations
J-ART
— Japanese Adverse Reaction Terminology
AHU
— Air Handling Unit
LOD
— Limit Of Detection
IUPAC
— International Union of Pure and Applied Chemistry
EO
— Executive Order
AS
— Aortic Stenosis
º
— section û shorthand symbol used to designate a section in a legal document; as in º201(m) of the FD&
DAILYMED
— NLM-based database of information on marketed drugs including FDA-approved labels.
CACBERS
— Committee for the Advancement of CBER Science
BP
— Blood Pressure
WYSIWYG
— What You See Is What You Get (pronounced Wizzy-wig. See Entry For Derived Acronyms)
SAR
— Search And Rescue
CONUS
— Continental United States (48 Contiguous States and DC)
NHLBI
— National Heart, Lung, and Blood Institute
ICAO
— International Civil Aviation Organization
FAPMC
— Food Animal Production Medicine Consortium
ADA
— Americans With Disabilities Act Of 1990 (Text Of ADA Legislation)
IDP
— Individual Development Plan
EEOC
— Equal Employment Opportunity Commission
QMS
— Quality Management System
SQL
— Structured Query Language
MTD
— Maximum Tolerated Dose (that does not produce unacceptable toxicity)
MCO
— Managed Care Organization
CGI
— Common Gateway Interface
OMB
— Office of Management and Budget (U.S.)
BUN
— Blood Urea Nitrogen
DL
— Deciliter
BX
— Biopsy
ECL
— Electrochemiluminescence
CC
— Chief Complaint
ARC
— American Red Cross
NIST
— National Institute of Standards and Technology
EEC
— European Economic Community (predecessor of the European Union|EU)
CFO
— Communication Filing Officer
MDV
— Medical Device Vigilance
TB
— Tuberculosis
SES
— Senior Executive Service
CRS
— Congressional Research Service
CAD
— Coronary Artery Disease
IATA
— International Air Transport Association
DJD
— Degenerative Joint Disease
EFT
— Electronic Funds Transfer
RA
— Rheumatoid Arthritis
FOIA
— Freedom of Information Act
FAO
— Food and Agriculture Organization of the United Nations
GSA
— U.S. General Services Administration
(B)(4)
— Freedom of Information Act Exemption 4, which protects from disclosure ôtrade secrets and commercial
DBMS
— Database Management System
GMP
— Good Manufacturing Practice
DOJ
— Department of Justice (US)
AMS
— Aseptic Meningitis Syndrome
ANA
— Antinuclear Antibody
CSF
— Cerebrospinal Fluid
PER DIEM
— Per Day allowance for daily travel expenses
HGB
— Hemoglobin
NPI
— National Provider Identifier
PNR
— Passenger Name Record
ICU
— Intensive Care Unit
ALARA
— As Low As Reasonably Achievable
HQ
— Headquarters (HDQ Preferred)
ARF
— Acute Renal Failure
NOS
— Network Operating System
MBC
— Minimum Bactericidal Concentration
NSC
— National Security Council
COP
— Continuation Of Pay
BEA
— Bureau of Economic Analysis
GU
— Genitourinary
COOP
— Continuity of Operations
AAAS
— American Association for the Advancement of Science
HAZMAT
— Hazardous Material
NTIS
— National Technical Information Service Technology Administration
IMO
— International Maritime Organization
ECRF
— Electronic Case Report Form
TDY
— temporary duty (non-unit-related personnel)
ISS/ISE
— Integrated Summary of Safety / Integrated Summary of Effectiveness
ME
— Medical Examiner
EEG
— Electro-EncephaloGram
CPAP
— Continuous Positive Airway Pressure
TPN
— Total Parenteral Nutrition
ADR
— Adverse Drug Reaction
C
— with (usually written with a bar on top of the "c")
UN
— United Narions
BPR
— Business Process Re-engineering
AIS
— Automated Information System
DNA
— Deoxyribose Nucleic Acid
USGS
— United States Geological Survey (DOI)
AAO
— American Academy of Ophthalmology
OAI
— Official Action Indicated (serious Food & Drug Administration post-inspection classification)
BPA
— Blanket Purchase Agreement
AQL
— Acceptable Quality Level
W3C
— World Wide Web Consortium
FAT
— Factory Acceptance Test
OASDI
— Old Age Survivors Disability Insurance
DKA
— Diabetic Ketoacidosis
BLM
— Bureau of Land Management of United States Department of the Interior
OPM
— Office of Personnel Management
CRF
— Chronic Renal Failure
CRO
— Contract Research Organization
LF
— Low Frequency
AAP
— American Academy of Pediatrics
GAO
— Government Accountability Office [formerly the General Accounting Office]
I&O
— Intake & Output
FTC
— Federal Trade Commission (U.S.)
CIA
— Central Intelligence Agency
IAW
— In Accordance With
ERP
— Enterprise Resource Planning
IVP
— Intravenous Pyelogram
RTF
— Rich Text Format
TEAE
— Treatment-Emergent Adverse Event
CHIP
— Children's Health Insurance Program
FASAB
— Federal Accounting Standards Advisory Board
ADME
— absorption, distribution, metabolism, and excretion
AVMA
— American Veterinary Medical Association
JPEG
— Joint Photographic Experts Group (24-bit image storage format)
AAEP
— American Association of Equine Practitioners
SWAT
— Special Weapons and Tactics
AUC
— Area under the Curve (statistics)
CJD
— Creutzfeldt-Jakob Disease
DCC
— Document Control Center
FECA
— Federal Employee's Compensation Act
ERT
— Emergency Response Team
DEA
— Drug Enforcement Administration (U.S. Department of Justice)
ODI
— Oswestry Disability Index
HCT
— Hematocrit
QOL
— Quality of Life
SSA
— Social Security Administration
AML
— Acute Myelogenous Leukemia
BNA
— Bureau of National Affairs, Inc.
NHANES
— National Health and Nutrition Examination Survey
ARRT
— American Registry of Radiologic Technologists
HCFA
— Health Care Financing Administration
TRO
— Temporary Restraining Order
BMI
— Body Mass Index
482
— FDA form for notice of inspection
SEC
— Securities and Exchange Commission (US)
CHO
— Carbohydrate
COI
— Conflict Of Interest
ADA
— American Dental Association
CM
— Configuration Management
DUNS
— Data Universal Numbering System
OPV
— Oral Polio Vaccine
TNTC
— Too Numerous To Count
USPS
— United States Postal Services
PVC
— Polyvinyl Chloride
WFI
— Water For Injection (pharmaceutical Term)
SIDS
— Sudden Infant Death Syndrome
Y2K
— Year 2000
CAPD
— Continuous Ambulatory Peritoneal Dialysis
HTN
— Hypertension
CRF
— Case Report Form
A2LA
— American Association for Laboratory Accreditation
ALJ
— Administrative Law Judge
DME
— Durable Medical Equipment
NCC MERP
— National Coordinating Council for Medication Error Reporting and Prevention
ITA
— International Trade Administration
APHIS
— U.S. Department of Agriculture's Animal and Plant Health Inspection Service
PPP
— Point-to-Point Protocol
USC
— United States Code (book of laws)
ABPI
— Association of the British Pharmaceutical Industry
NAFTA
— North American Free Trade Agreement
EBS
— Emergency Broadcast System
NBS
— National Bureau of Standards (US)
IPCS
— International Programme on Chemical Safety
RNA
— Ribo Nucleic Acid
CSR
— Clinical Study Report
ARDS
— Acute Respiratory Distress Syndrome
SSRI
— Selective Serotonin Reuptake Inhibitor
ESD
— Electrostatic Discharge
MRP
— material requirements planning
EMC
— Electromagnetic Compatibility
CRA
— Clinical Research Associate
EFTA
— European Free Trade Association (Geneva)
UMDNS
— Universal Medical Device Nomenclature System
ECE
— Economische Commissie voor Europa (United Nations) (Dutch: Economic Commission for Europe)
AAFP
— American Academy of Family Physicians
CVD
— Cardiovascular Disease
CAPA
— Corrective And Preventive Action
T&A
— Time & Attendance
IVF
— in vitro fertilization;
I&D
— Incision and Drainage
CMV
— Cytomegalovirus
CME
— Continuing Medical Education
FERC
— Federal Energy Regulatory Commission (U.S.)
NEC
— not elsewhere classified
NOD
— Notice of Deficiency
DI
— Diabetes Insipidus
CDRH
— Center for Devices and Radiological Health (Food & Drug Administration)
APHA
— American Public Health Association
NTIA
— National Telecommunications and Information Administration
PCR
— Polymerase Chain Reaction
C&S
— Culture and Sensitivity
APIC
— Active Pharmaceutical Ingredients Committee (of CEFIC)
AASP
— American Association of Swine Practitioners
NCE
— New Chemical Entity
AANS
— American Association of Neurological Surgeons
CONOPS
— Concept of Operations
BMR
— Basal Metabolic Rate
BSA
— Body Surface Area
PHI
— Protected Health Information
AACR
— American Association for Cancer Research
PIN
— Personal Identification Number
ASBPO
— Armed Services Blood Program Office
OPO
— Organ Procurement Organization
SAL
— Sterility Assurance Level
TCP/IP
— transmission control protocol/internet protocol
HCG
— Human Chorionic Gonadotropin
ORR
— Objective Response Rate
ALT
— Alanine Aminotransferase
AALAS
— American Association for Laboratory Animal Science
CRCL
— Creatinine Clearance
AABP
— American Association of Bovine Practitioners
510(K)
— Food, Drug, and Cosmetic Act Section 501(k), Pre-Market Notification
CPK
— Creatinine Phosphokinase
SMPC
— Summary of Product Characteristics
SAMHSA
— Substance Abuse and Mental Health Services Administration
SPC
— Summary of Product Characteristics
AHA
— American Hospital Association
ACG
— American College of Gastroenterology
AFP
— Alpha Fetoprotein
EH & S
— environmental health and safety
EAR
— Export Administration Regulations
AAPM
— American Association of Physicists in Medicine's
MI
— Myocardial Infarction
OLE
— Object Linking and Embedding (Microsoft communication protocol)
IRDM
— Insulin Resistant Diabetes Mellitus
AAI
— American Association of Immunologists
CPE
— Continuing Professional Educational
FBS
— fasting blood sugar
HDPE
— High Density Polyethylene Electrical
PR
— Public Relations
HCO
— Health Care Organization
AASRP
— American Association of Small Ruminant Practitioners
ASM
— American Society for Microbiology
DMR
— Device Master Record
AAVMC
— Association of American Veterinary Medical Colleges
AST
— Aspartate Aminotransferase
SIP
— Sterilization in Place
CE
— Continuing Education
CHD
— Coronary Heart Disease
ICS
— Incident command system
BOS (CBER)
— Building Operations Staff (CBER)
AFIA
— American Feed Industry Association
CBG
— Capillary Blood Gas
HHS
— U.S. Department of Health and Human Services
FOUO
— For Official Use Only
USA
— United States Army
TOC
— Total Organic Carbon
CRP
— Cold Reactive Protein
BIA
— Bureau of Indian Affairs (U.S.)
LOCF
— Last Observation Carried Forward
ULN
— upper limit of normal
TSP
— Thrift Savings Plan
TLC
— Thin Layer Chromatography
BSL
— Biosafety Level
PUD
— Peptic Ulcer Disease
CCC
— Commodity Credit Corporation
CCC
— Chinese ceramicware factory code (ORA AofC code)
DMARD
— disease-modifying antirheumatic drug
SBA
— Small Business Administrations
ELISA
— enzyme-linked immunosorbent assay
ADAMHA
— Alcohol, Drug Abuse, and Mental Health Administration (now SAMHSA)
RH
— Relative Humidity
CEA
— Council of Economic Advisors
DMF
— Drug Master File
ANPRM
— Advance Notice of Proposed Rule Making
OOB
— OOS out of business
AAVLD
— American Association of Veterinary Laboratory Diagnosticians
ACIP
— Advisory Committee on Immunization Practices
EC
— European Community
SHOP
— Small Business Health Options Program
CI
— Confidential Informant
DC
— Discharge
AODM
— Adult-Onset Diabetes Mellitus
ADAP
— AIDS Drug Assistance Program
BRFSS
— Behavioral Risk Factor Surveillance System
VHA
— Veterans Health Administration's
CIR
— Cosmetic Ingredient Review
HX
— Medical History
SQ
— Subcutaneous
BBB
— Bundle Branch Block
PKI
— Public Key Infrastructure (cryptography)
IDDM
— insulin-dependent diabetes mellitus
MIC
— Minimum Inhibitory Concentration
FMRI
— Functional Magnetic Resonance Imaging
PIM
— Product Information Management
DNS
— Domain Name Server
CAP
— College of American Pathologists
ASHD
— AtheroSclerotic Heart Disease
AHCPR
— Agency for Health Care Policy and Research
RUO
— Research Use Only
AE
— Adverse Event
CFOC
— Chief Financial Officers Council
FDA BLA
— Food and Drug Administration - Biologicals License Application
ATSDR
— Agency for Toxic Substance and Disease Registry
NABR
— National Association for Biomedical Research
NS
— Not Significant
NAI
— No Action Indicated (Most Favorable Food & Drug Administration Post-inspection Classification)
BPD
— Bronchopulmonary Dysplasia
CMP
— Civil Money Penalty
CO
— Compliance Officer
NMFS
— National Marine Fisheries Services
21 CFR PART 314 SUBPART H
— Subpart of Part 314 pertaining to accelerated approval of drugs
QWL
— Quality of Work Life
SAR
— Specific Absorption Rate
CPT
— Current Procedural Terminology
ORNL
— Oak Ridge National Laboratory's
NOC
— National Operations Center
PDCA
— Plan-do-check-action
FERS
— Federal Employees Retirement System
FMECA
— failure modes, effects, and criticality analysis
PBM
— Pharmacy Benefits Management (or Manager)
DC
— discontinue
NASA
— National Aeronautics and Space Administration (US)
EMV
— eye-motor-verbal (Glasgow coma scale)
EEA
— European Economic Area
FTT
— Failure To Thrive
PHS
— Public Health Service (U.S.)
USP
— United States Pharmacopeia
NTG
— Nitroglycerin
DHHS
— Department of Health and Human Services (U.S.)
EINECS
— European Inventory Of Existing Commercial Chemical Substances
ALL
— Acute Lymphocytic Leukemia
TSH
— thyroid stimulating hormone
SF
— Standard Form
USCG
— United States Coast Guard
CPP
— Critical Process Parameter
CEQ
— Council on Environmental Quality (U.S.)
RX
— prescriptions
CINAHL
— Cumulative Index to Nursing and Allied Health Literature
AVDA
— American Veterinary Distributors Association
MSSO
— Maintenance and Support Services Organization
DIA
— Drug Information Association
DLI
— Donor Lymphocyte Infusion
BMS (OC)
— Broadcast Media Staff (OC)
PPTP
— Point-to-Point Tunneling Protocol
HBP
— High Blood Pressure
ASIC
— Application Specific Integrated Circuit
OSTP
— Office of Science and Technology Policy
ANDA
— Abbreviated New Drug Application (for a generic drug)
ACF
— Administration for Children and Families
RSS
— Really Simple Syndication
LD
— Lethal Dose
CP
— Cerebral Palsy of New Jersey
IIS
— Internet Information Services
CCR
— Center for Cancer Research
MDR
— Medical Device Reporting
TVA
— Tennessee Valley Authority (US) (electricity)
ARS
— United States Department of Agriculture's Agricultural Research Service
NCBA
— National Cattlemen's Beef Association
DVD
— Digital Video Disc
DSMB
— Data Safety Monitoring Board
ARENA
— Applied Research Ethics National Association
WBC
— White blood cells
QNS
— Quantity Not Sufficient
SBIR
— Small Business Innovation Research
ASR
— Analyte Specific Reagent
VMS
— Virtual Memory System
TDI
— Tolerable Daily Intake
IMS
— Information Management System (LTPP)
CAB
— Conformity Assessment Body
CERT
— Community Emergency Response Team
PHRMA
— Pharmaceutical Research and Manufacturers of America (formerly PMA, Pharmaceutical Manufacturers Association)
AAHA
— American Animal Hospital Association
GM
— Genetic Modification
FONSI
— Finding of no significant impact. See Environmental impact statement (US)
KCAL
— kilocalories
DIA
— Defense Intelligence Agency (USA)
REMS:
— Risk Evaluation and Mitigation Strategies
CFDA
— Catalog of Federal Domestic Assistance
RDA
— Recommended Daily Allowance
MTBF
— Mean Time Between Failures
CRO
— Clinical Research Organization
COLD
— Chronic Obstructive Lung Disease
MAC
— Mental Adjustment to Cancer Scale
NACMCF
— National Advisory Committee on Microbiological Criteria for Foods
SAE
— Serious Adverse Event
EPFA
— European Plasma Fractionation Association
NARA
— United States National Archives And Records Administration
GCP
— Good Clinical Practice
FPS
— Federal Protective Service
QS
— Quality System
AAAP
— American Association of Avian Pathologists
SNDA
— Supplemental New Drug Application
RVU
— Relative Value Unit
NTP
— National Toxicology Program
PADER
— Periodic Adverse Drug Experience Report
LSD
— Lysergic Acid Diethylamide
USAHA
— United States Animal Health Association's
JTF
— Joint Task Force
MOD 1
— Module One laboratory facility
NWS
— National Weather Service (formerly U.S. Weather Bureau)
NASDA
— National Association of State Departments of Agriculture
GLP
— Good Laboratory Practice
IV&V
— independent verification and validation
FEI
— FDA Establishment Identifier (ORA)
AMS
— Agricultural Marketing Service
TMJ
— TemporoMandibular Joint (syndrome)
HDL
— High-Density Lipoprotein (a type of cholesterol)
PNNL
— Pacific Northwest National Laboratory (DOE) (US)
LOQ
— Limit Of Quantification
DES
— diethyl sulphate
ASCP
— American Society for Clinical Pathology
CCU
— Clean Catch Urine
ODAC
— Oncologic Drugs Advisory Committee (U.S.)
NICE
— National Institute for Health and Clinical Excellence
CP
— Chest Pain
RIA
— Radio Immuno-Assay
HVAC
— Heating, Ventilating, And Air Conditioning
CTC
— Common Toxicity Criteria
GEP
— Good Engineering Practice
HFA
— HydroFluoroAlkane
SRD
— System Requirements Document
BFAD
— Bureau of Food & Drug Administration
NCI
— National Cancer Institute, USA
SC
— Subcutaneous
DODAAC
— Department Of Defense Activity Address Code
RBRVS
— Resource-Based Relative Value Scale
A-V
— ArterioVenous
CTFA
— Cosmetic, Toiletry, and Fragrance Association
SDS-PAGE
— Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis
HA
— Headache
DOI
— Department of the Interior (US)
USAID
— United States Agency for International Development
TDD
— Telecommunications Device for the Deaf
CRADA
— Cooperative Research and Development Agreement (with National Institutes of Health)
MDI
— Metered-Dose Inhaler
QHS
— quaque hora somni (every night at bedtime)
DIBD
— Development International Birth Date
IRM
— Information Resources Management
CTCAE
— Common Terminology Criteria for Adverse Events
ANA
— Administration for Native Americans
CN
— Cranial Nerve
LMO
— Living Modified Organism
OVR
— Operations Variance Report
EDMS
— Electronic Document Management System
IB
— Investigator's Brochure
NDC
— National Drug Code
GDS
— Global Distribution System
IG
— Inspector General (HHS)
IBD
— International Birth Date
ICMJE
— International Committee of Medical Journal Editors
NIEHS
— National Institute of Environmental Health Sciences (National Institutes of Health)
LGA
— large for gestational age
PART
— Program Assessment Rating Tool
CEF
— chick embryo fibroblast
CIOMS
— Council for International Organizations of Medical Sciences
HCI
— Human-Computer Interaction
PFGE
— Pulsed-Field Gel Electrophoresis
CDER
— Center for Drug Evaluation and Research (Food & Drug Administration)
FORM 482
— Notice Of Inspection
BSI
— British Standards Institute
CIP
— Critical Infrastructure Protection (US)
BAM
— Bacteriological Analytical Manual
CGL
— Chronic Granulocytic Leukemia
DESI
— Drug Efficacy Study Implementation Notice (Food & Drug Administration, to evaluate drugs in use befaore 1962)
JECFA
— Joint (FAO/WHO) Expert Committee on Food Additives
DUR
— Drug Utilization Review
TLA
— Three-Letter Acronym
EMI
— Electro-Magnetic Interference
SUSAR
— Suspected Unexpected Serious Adverse Reactions
GHTF
— Global Harmonization Task Force
APHA
— American Pharmaceutical Association
FFS
— Fee-For-Service
VAX
— Virtual Address Extension
IEEE
— Institute of Electrical and Electronics Engineers
NCCDPHP
— National Center for Chronic Disease Prevention and Health Promotion
CAP
— Corrective Action Plan
CSR
— Center for Scientific Review
UIN
— Unique Identification Number
DSUR
— Development Safety Update Report
INCI
— International Nomenclature of Cosmetic Ingredients
EFD
— Engineering Flow Diagram
HAV
— Hepatitis A Virus
FDASS (OC)
— FDA Safety Staff (OC)
WHO-ART
— World Health Organisation Adverse Reaction Terminology
E2B
— FDA Working Group that defined Efficacy Topics' Data Elements for Transmission of Adverse Drug Reactions Reports
CRB
— Change Review Board
NHC
— United States National Hurricane Center
NPR
— National Performance Review (office)
R-CHOP
— Drug combination that includes rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
IND
— Investigational New Drug
SEER
— Surveillance, Epidemiology, and End Results
WB
— Western Blot
PFS
— Piper Fatigue Scale
ICRP
— International Commission on Radiological Protection
NICHD
— National Institute of Child Health and Human Development
AANN
— American Association of Neurosciences Nurses
PERV
— Porcine Endogenous Retrovirus
QSR
— Quality System Regulation
FNS
— Food and Nutrition Service
ETOH
— Ethyl Alcohol (Ethanol)
IACUC
— Institutional Animal Care and Use Committee
UL
— Underwriters Laboratories
HIMA
— Health Industry Manufacturers Association
ENL
— Erythema Nodosum Leprosum
BIO
— Biotechnology Industry Organization
AD LIB
— As Much As Needed
BW
— Body Weight
ANPR
— Advance Notice of Proposed Rulemaking
GMDN
— Global Medical Device Nomenclature
SARS
— Severe Acute Respiratory Syndrome
TRB
— Technical Review Board (MRR)
AADA
— Abbreviated Antibiotic Drug Application
GAP
— Good Agricultural Practice
AERS
— Adverse Event Reporting System (Food & Drug Administration)
CMA
— Chemical Manufacturers Association
CHMP
— Committee for Medicinal Products for Human Use
VAI
— Voluntary Action Indicated (Food & Drug Administration postaudit inspection classification)
HIM
— Health Information Management
SX
— syndrome X
AFGE
— American Federation of Government Employees
JAD
— Joint Application Development
CVA
— Costovertebral Angle
OQ
— Operational Qualification
WHO
— World Health Organisation
MEDPAC
— Medicare Payment Advisory Commission
CSB
— Chemical Safety and Hazard Investigation Board
LIMS
— Laboratory Information Management System
LAF
— Laminar Air Flow
GS
— General Schedule
PETA
— People for the Ethical Treatment of Animals
GCLP
— Good Clinical Laboratory Practice
SMO
— Site Management Organization
TOI
— Trial Outcome Index
USP-DI
— United States Pharmacopeia-Drug Information
FDLI
— Food and Drug Law Institute
DART
— Developmental And Reproductive Toxicology (database / base de données)
NIA
— National Institute on Aging
API
— Active Pharmaceutical Ingredient
EHR
— Electronic Health Record
IHS
— Indian Health Service
RFA
— Request For Application
PKU
— Phenylketonuria
ADMS
— Alcohol, Drug Abuse and Mental Health Services
EH&S
— Environmental Health and Safety
LS/LS
— Life Supporting/Life Sustaining
HRSA
— U.S. Health Resources and Services Administration
CBER
— Center for Biologics Evaluation and Research
TRI
— Toxics Release Inventory
ABI
— Automated Broker Interface
DURSA
— Data Use and Reciprocal Support Agreement
HTML
— Hyper-Text Markup Language
URS
— User Requirement Specification
TSE
— Transmissible Spongiform Encephalopathies
ICF
— Informed Consent Form
NVLAP
— National Voluntary Laboratory Accreditation Program
NIMS
— National Incident Management System
NEHA
— National Environmental Health Association
DICOM
— Digital Imaging and Communications in Medicine
PWS
— Performance Work Statement
CIAC
— Computer Incident Advisory Capability
CPCSEA
— Committee for the Purpose of Control and Supervision on Experiments on Animals (India)
ETASU
— Elements To Assure Safe Use
COP
— Clean Out of Place
BATF
— Bureau of Alcohol, Tobacco, & Firearms
FDASIA
— Food and Drug Administration Safety and Innovation Act
CIN
— Color Index number (ORA AofC code)
TSCA
— Toxic Substances Control Act of 1976
PAO
— Public Affairs Officer
TROIF
— Total Recordable Occupational Illness Frequency
VMP
— Validation Master Plan
BB IND
— Biological-Based Investigational New Drug
OASH
— Office of the Assistant Secretary for Health
CIT
— Center for Information Technology
PK
— Pharmacokinetics
CAS
— Chemical Abstract Service
CTD
— Common Technical Document
TRALI
— transfusion-related acute lung injury
QAO
— Quality Assurance Office
ACR
— American College of Radiology
A/L
— Annual Leave
ASA
— American Statistical Association
SRS
— Spontaneous Reporting System
FQ
— Fluoroquinolone
ORANGE BOOK
— Approved Drug Products with Therapeutic Equivalence Evaluations
CWD
— Chronic Wasting Disease
VSD
— Vaccine Safety Datalink
NCRP
— National Council on Radiation Protection and Measurements
DVT
— Deep Venous Thrombosis
SRCS
— Division of Surveillance, Research, and Communication Support
QCP
— Quality Control Program
QSAR
— Quantitative Structure Activity Relationship
CGMP
— current Good manufacturing practicess
ADVAMED
— Advanced Medical Technology Association
NETBEUI
— NETBIOS Extended User Interface
MMWR
— Morbidity and Mortality Weekly Report
POV
— Privately-Owned Vehicle. A Soldier's Personal Automobile.
CFG
— Certificate for Foreign Government
NAL
— National Agricultural Library
NIGMS
— National Institute Of General Medical Sciences (NIH)
ASA
— Aminosalicylic Acid
CEU
— Continuing Education Units
INDA
— Investigational New Drug Application
RCT
— randomized controlled trial
ICH
— International Conference on Harmonization (of Technical Requirements for Registration of Pharmaceuticals for Human Use)
ONC
— Office of the National Coordinator for Health Information Technology (United States Government Health and Human Services)
BLA
— Biologics License Application (Food & Drug Administration)
CPSC
— Consumer Product Safety Commission
DGFPS
— Direccion General de Farmacia y Productos Sanitarios (Directorate General of Pharmacy and Sanitary Products) (Spain)
PCS
— Permanent Change Of Station. Reassignment To A Different Duty Station.
NCHS
— National Center for Health Statistics standards
EKG
— electrocardiogram
PTU
— Propylthiouracil
AID
— Agency for International Development (U.S.)
AMFAR
— American Foundation for AIDS Research
IMPD
— Investigational Medicinal Product Dossier (EU)
ACEP
— American College of Emergency Physicians
DILI
— drug-induced liver injury
SGA
— small for gestational age
ICD
— Informed Consent Document
OOS
— Out Of Specification
CFC
— Combined Federal Campaign
FACT
— Functional Assessment of Cancer Therapy--General
ECU
— European Currency Unit
ERCP
— Endoscopic Retrograde Cholangio-pancreatography Procedures
MDMA
— Medical Device Manufacturers Association
PACE
— Patient-centered Assessment and Counseling for Exercise
MMA
— Medicare Prescription Drug, Improvement and Modernization Act of 2003
AV
— Atrio-Ventricular (cardiac)
FASEB
— Federation of American Societies for Experimental Biology's
SCD
— Service Computation Date
DTC
— Direct-to-Consumer (drug advertising)
CASE
— Computer-Aided Software Engineering
PMAP
— Performance Management Appraisal Program
FTS
— Federal Telecommunications System
FOI
— Freedom of Information
NCBI
— National Center for Biotechnology Information
DFAS
— Defense Finance & Accounting Service
JCAHO
— Joint Commission on Accreditation of Health Care Organizations
KOS
— Knowledge Organization System
DPAMS
— Division of Pre-marketing Assessment III and Manufacturing Science
HFD
— Headquarters, FDA Drug; mail code for Center for Drug Evaluation and Research
FACA
— Federal Advisory Committee Act 1972
CRC
— Clinical Research Coordinator
MEDEC
— Medical Devices Canada
IQ
— Installation Qualification
RSS
— Rich Site Summary
SOPP
— Standard Operating Procedures and Policies
CSR
— Customer Service Record
USPSTF
— United States Preventive Services Task Force
DAWN
— (U.S.) Drug Abuse Warning Network
SNL
— Sandia National Laboratories
ADP
— Alternative Disposition Plan
FARAD
— Food Animal Residue Avoidance Databank
CHPA
— Consumer Healthcare Products Association
CTC
— Chlortetracycline
CFU
— Colony Forming Unit (for Bacteria Counting In Water Disinfection)
AOA
— Administration on Aging
MERP
— Medication Error Reporting and Prevention
ERC
— Engineering Research Center
AWP
— Average Wholesale Price
TESS
— Treatment-Emergent Signs and Symptoms
ASAP
— Administrative Systems Automation Project (Food & Drug Administration)
USCA
— United States Code Annotated
CRMTS
— CBER (Center for Biologics Evaluation and Research) Regulatory Meetings management Tracking System
NIDA
— National Institute on Drug Abuse (National Institutes of Health)
EFPIA
— European Federation of Pharmaceutical Industries and Associations
DPT
— Diphtheria, Pertussis And Tetanus
JIC
— Joint Information Center
MFCU
— Medicaid Fraud Control Unit
NACDS
— National Association of Chain Drug Stores
IPV
— Inactivated Polio Vaccine
NEI
— National Eye Institute (National Institutes of Health)
N.B.
— nota bene (note well)
AL
— Annual Leave
USCS
— United States Customs Service
SHE
— Safety, Health and Environmental
ARCRT
— American Registry of Clinical Radiography Technologists
APLB (CBER)
— Advertising and Promotional Labeling Branch (Center for Biologics Evaluation and Research)
HPFB
— Health Products and Food Branch (Canada)
NHIN
— Nationwide Health Information Network
SPAC
— State Pharmaceutical Administration of China
DWPE
— Detention without Physical Examination
ICRU
— International Commission on Radiation Units and Measurements
DRLM
— Device Registration and Listing Module (FURLS)
AIM
— Active Ingredient Manufacturer
USIA
— United States Information Agency (changed To IIP)
OGE
— Office of Government Ethics (formerly part of Office of Personnel Managment, separate executive branch in 1989)
GXP
— Good "x" Practices (x = any type of practice)
SCOGS
— Select Committee On GRAS (Generally Recognized As Safe) Substances
CAMP
— Childhood Asthma Management Program
BGA
— BundesGesundheitsAmt (German Federal Health Office)
HAART
— Highly Active Antiretroviral Therapy ヨ the name commonly given to combinations of anti-HIV drugs
MF
— Master File
ABCS
— Active Bacterial Core Surveillance
CNS
— Congress of Neurological Surgeons
LRI
— Lower Respiratory Infection
HHMI
— Howard Hughes Medical Institute
NGA
— National Geospatial-Intelligence Agency (formerly National Imagery and Mapping Agency; US government)
DAL
— Defect Action Level
ASCO
— American Society of Clinical Oncology's
MTCT
— mother-to-child transmission
ED
— Effective Dose
NIDCR
— National Institute of Dental and Craniofacial Research
NLEM
— National List of Essential Medicines
OIP
— Office of International Programs
EAS
— Emergency Alert System
PDMP
— Prescription Drug Monitoring Program
LF3
— Low-value Foor or Food-related products, level 3 (between $500 and $1000)
LOAEL
— Lowest Observed Adverse Effect Level
OSHRC
— Occupational Safety and Health Review Commission
ASGE
— American Society for Gastrointestinal Endoscopy
CITES
— Convention on International Trade in Endangered Species of Wild Fauna and Flora
RRCC
— Regional Response Coordination Center
D & C
— Dilation and Curettage
COE
— Center of Excellence
ADMC
— Advance Determination of Medicare Coverage
LES
— Leave and Earnings Statement
EWG
— Expert Working Group
NBII
— National Biological Information Infrastructure
AC
— Advisory Committee
RM
— Raw Material
CSTE
— Council of State & Territorial Epidemiologists
VADM
— Vice Admiral
RPSGB
— Royal Pharmaceutical Society of Great Britain
BVB
— Bacterial Vaccine and Allergenic Products Branch
ORISE
— Oak Ridge Institute for Science and Education
AHF
— Antihemophilic Factor
SUPAC-IR
— Scale-Up and Post-Approval Changes - Immediate Release
VAERS
— Vaccine Adverse Event Reporting System
NARB
— National Advertising Review Board
QP
— Qualified Person
MMR
— measles, mumps, and rubella
CSV
— Computer System Validation
NIBIB
— National Institute of Biomedical Imaging and Bioengineering
EDIPI
— Electronic Data Interchange Personal Identifier
CA
— Chemical Abstracts
ACS (CDER)
— Advisors and Consultants Staff (Center for Drug Evaluation and Research)
SSED
— Summary of Safety and Effectiveness Data
QSIT
— Quality System Inspection Technique
VFD
— Veterinary Feed Directive
BT ACT
— Bioterrorism Act (Public Health Security and Bioterrorism Preparedness and Response Act of 2002)
HEPA
— High-Efficiency Particulate Air filter
SCR
— System Change Request
ASTHO
— Association of State and Territorial Health Officials
BOCF
— Baseline Observation Carried Forward
SG
— Surgeon General
URL
— Uniform Resource Locator
STEPS
— System for Thalidomide Education and Prescribing Safety
TVC
— Total Viable Count
AAFCO
— Association of American Feed Control Officials
GHC
— Group Health Cooperative
FFDCA
— Federal Food, Drug and Cosmetic Act of 1938
NCDC
— National Centre for Disease Control, India
PHPPO
— Public Health Practice Program Office
RDNA
— Recombinant Deoxyribonucleic Acid
HL7
— Health Level 7 (a not-for-profit ANSI-accredited standards-developing organization (SDO)
DBRA
— Division of Biometry and Risk Assessment
CEFIC
— Conseil Européen des Fédérations de l'Industrie Chimique (European Chemical Industry Council
OP 2 (OC)
— Operations Team 2 (OC)
BPE
— Bulk Pharmaceutical Excipients
SPECT
— single-photon emission computed tomography
APAP
— N-Acetyl-Para-Amino-Phenol
COS
— Certificate of Suitability
USACE
— United States Army Corps of Engineers
GIS
— Geographical Information System
AWS
— Alternate Work Schedule
SDO
— Standards Development Organization
FSH
— Follicular Stimulating Hormone
DCU
— Document Control Unit
DMAT
— Disaster Medical Assistance Team
STAMP
— Systematic Technology Assessment of Medical Products
BIVAS
— Body Image Visual Analog Scale
CBP
— Customs and Border Protection
ABC
— American Blood Commission
FEB
— Federal Executive Board
HCTZ
— Hydrochlorothiazide
OCR
— Office of Civil Rights
ADEERS
— Adverse Event Expedited Reporting System
FFLA
— Family Friendly Leave Act
NCEH
— National Center for Environmental Health
PERI
— Pharmaceutical Education & Research Institute
COA
— Certificate of Analysis
HSA
— Health Services Administration
NIAAA
— National Institute on Alcohol Abuse and Alcoholism
BCPT
— Breast Cancer Prevention Trial
SIP
— Summer Internship Program
HRG
— Health Research Group
FPLA
— Fair Packaging and Labeling Act of 1967
EAA
— essential amino acidsolution
BPCI ACT
— Biologics Price Competition and Innovation Act of 2009
NIS
— National Inpatient Sample
FD&C ACT
— Federal Food, Drug, and Cosmetic Act of 1938
JINAD
— Generic Investigational New Animal Drug File
3500A
— FDA form for mandatory reporting of adverse events
OM (CDER)
— Office of Management (Center for Drug Evaluation and Research)
CATCH
— Child and Adolescent Trial for Cardiovascular Health
SCLIR
— Secondary Calibration Laboratories for Ionizing Radiation
DNP (CDER)
— Division of Neurology Products (Center for Drug Evaluation and Research)
CIRMS
— Council on Ionizing Radiation Measurements and Standards
FCCSET
— Federal Coordinating Council for Science, Engineering, and Technology
AMP
— Average Manufacturer Price
PARQ
— Physical Activity Readiness Questionnaire
FALCPA
— Food Allergen Labeling and Consumer Protection Act
USPTO
— United States Patent and Trademark Office
HSPD
— Homeland Security Presidential Directive
NACCHO
— National Association of County and City Health Officials
OPDP
— Office of Prescription Drug Promotion (CDER) (formerly Division of Drug Marketing, Advertisement and
ORI
— Office of Research Integrity
CRL
— Complete Response Letter
VEE
— Venezuelan Equine Encephalomyelitis
CRCPD
— Conference of Radiation Control Program Directors
C/CC
— Career or Career Conditional
OIT (CDER)
— Office of Information Technology (Center for Drug Evaluation and Research)
NIOSH
— National Institute for Occupational Safety and Health (CDC)
GRAS
— Generally Recognized As Safe
NIDDK
— National Institute of Diabetes and Digestive and Kidney Diseases
MLD
— Minimum Lethal Dose
KS
— Kaposi's Sarcoma
MQSA
— Mammography Quality Standards Act of 1992
2301
— FDA form for transmittal of periodic reports and promotional material for new animal drugs
CC
— Coordinating Committee
STN
— Submission Tracking Number
LOC
— Level Of Concern
ORP (CDER)
— Office of Regulatory Policy (Center for Drug Evaluation and Research)
TSCSB (CFSAN)
— Telecommunications and Scientific Computer Support Branch (CFSAN)
AOB (OC)
— Accounting Operations Branch (OC)
RR
— Relative risk of death
PHA
— Public Health Advisory
JBIG
— Joint Bi-level Image experts Group
EDMF
— European Drug Master File
BECON
— Bioengineering Consortium
PDB (CDER)
— Prescription Drugs Branch (Center for Drug Evaluation and Research)
FAERS
— FDA Adverse Event Reporting System
CDASH
— Clinical Data Acquisition Standards Harmonization
SRM
— Specified Risk Material
MRL
— Maximum Residue Limit
CTDB 1 (CDRH)
— Chemistry and Toxicology Devices Branch 1 (CDRH)
SAP
— Service Access Point
DCPS
— Defense Civilian Pay System
ER
— Extended-Release
NCHSTP
— National Center for HIV, STD, & TB Prevention
TTTC
— Take Time To Care
PDO
— Protected Designation of Origin
MCAFT
— Modified Canadian Aerobic Fitness Test
BPAC
— Blood Products Advisory Committee
BRAPP
— British Association of Pharmaceutical Physicians
DV
— Daily Values
PADE
— Postmarketing Adverse Drug Experience
TCS
— Temporary Change of Station
GME
— Graduate Medical Education
SBRS
— SENIOR BIOMEDICAL RESEARCH SERVICE
ASPE
— Assistant Secretary for Planning and Evaluation
WFH
— World Federation of Hemophilia
RAD
— Rapid Application Design
CMP/ HMO
— Comprehensive Medical Plan/Health Maintenance Organization
LRC
— Lipid Research Clinic
DIT (CDRH)
— Division of Information Technology (Center for Drug Evaluation and Research)
DHSS
— Department of Health and Social Security (U.K.)
ESF
— Emergency Support Function
DFO
— Designated Federal Official
DONED
— Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices (CDRH)
C
— Gl With Glasses
NLEA
— Nutrition Labeling and Education Act of 1990
DIN
— Drug Identification Number
KPS
— Karnofsky Performance Status scale
ATC
— Anatomical Therapeutic Chemical
IARC
— International Agency for Research on Cancer
CHCB (CFSAN)
— Chemical Contaminants Branch (CFSAN)
CEARS
— CBER (Center for Biologics Evaluation and Research) Error and Accident Reporting System
OD
— Office of the Director
WG
— Wage Grade
GBL
— Government Bill of Lading
NSAPB
— National Surgical Adjuvant Breast and Bowel Project
NVP
— National Vaccine Program
ESIG
— Electronic Signature
C-TPAT
— Customs-Trade Partnership Against Terrorism
ACBSA
— Advisory Committee on Blood Safety and Availability
M4
— ICH M4 Expert Working Group (EWG) [focusing on Common Technical Documents for sections of the NDA]
CLSI
— Clinical and Laboratory Standards Institute
PEB 1 (CDRH)
— Postmarket Evaluation Branch 1 (Center for Devices and Radiological Health)
AT
— antithrombin III
BISTIC
— Biomedical Information Science and Technology Initiative Consortium
SSOP
— Sanitation Standard Operating Procedures
AE(S)
— adverse event(s)
PMN
— Pre-Market Notification
COLA
— Cost Of Living Allowance
OP (OC)
— Office of Policy (Office of the Commissioner)
NS/EP
— National Security and Emergency Preparedness
DCPA (CBER)
— Division of Congressional and Public Affairs (Center for Biologics Evaluation and Research)
TEB (CBER)
— Therapeutics Evaluation Branch (CBER)
NCDCP
— National Council on Prescription Drug Programs
PCP
— Pneumocystis Carinii Pneumoniae
ISSO
— Information Systems Security Officer
FFD & C
— Federal Food, Drug and Cosmetic Act of 1938
SUPAC-SS
— scale-up and postapproval changes--nonsterile solid
RCR
— Replication Competent Retrovirus
DTAP
— diphtheria, tetanus and acellular pertussis
NCTR
— National Center for Toxicological Research
OWH (OC)
— Office of Women's Health (OC)
CIP
— Clean-In-Place
C
— Gl With Correction
UPLC
— Ultra Performance Liquid Chromatography
NMA
— National Medical Association
OSHA
— Occupational Safety and Health Administration (U.S. Department of Labor)
DHCP
— Dear Health Care Professional
CT
— Clinical Trial
FORM 3500A
— Mandatory Reporting of Adverse Events
OM (OC)
— Office of Management (Immediate Office of the Commissioner)
NCCAM
— National Center for Complementary and Alternative Medicine
MAH
— Marketing Authorization Holder
DAA
— Designated Approving Authority
SBOA
— Summary Basis of Approval
CDM
— Clinical Data Management
CSM
— Committee on Safety of Medicines
DRLS
— Drug Registration and Listing System
HTLV
— human T-lymphotropic viruse
AATB
— American Association of Tissue Banks
QMIS
— Quality Management Information System
NUCC
— National Uniform Claim Committee
OBE
— Online Booking Engine
DFS (ORA)
— Division of Field Science (ORA)
CAPAR
— Corrective Action Preventive Action Report
PQRI
— Product Quality Research Institute
WITS
— Washington Interagency Telecommunications System
EP
— European Pharmacopoeia
QBD
— Quality by Design
SID
— Source-to-Image Distance
USJFCOM
— United States Joint Forces Command
ECTD
— Electronic Common Technical Document
SOC
— System Organ Classification
C OF A
— Certificate of Analysis
OIT (CBER)
— Office of Information Technology (Center for Biologics Evaluation and Research)
TEACA
— Trolox-Equivalent Antioxidant Capacity Assay
DHF
— Design History File
DIHD (CDRH)
— Division of Immunology and Hematology Devices (CDRH)
NHW
— National Health and Welfare Department (Canada's equivalent of DHHS)
CDC
— Centers for Disease Control and Prevention
CLT
— Central Limit Theorem
EPAR
— European Public Assessment Report
NF
— National Formulary
USRDS
— United States Renal Data System
ACRPI
— Association of Clinical Research for the Pharmaceutical Industry
PDCS (OC)
— Policy Development and Coordination Staff (OC)
HDF
— mail code for CDER (Center for Drug Evaluation and Research)
EPC
— Evidence-based Practice Center
1932A
— FDA form for veterinary adverse drug reaction, lack of effectiveness, product defect report--voluntary
CODEX
— Codex Alimentarius collection of food standards
GXT
— graded exercise tolerance (Stress test)
C & S
— Culture and Sensitivity
IFT
— Institute of Food Technologists
ITIPS
— Information Technology Investment Portfolio System
S/L
— Sick Leave
MEG
— Magnetoencephalography
MOD 2
— Module Two laboratory facility
RAMP
— Remedial Action Management Program
OFPA
— Organic Foods Production Act of 1990
LR1
— Low-value non-prescription Radiation-emitting products, level 1 (less than $200)
DSHEA
— Dietary Supplement and Health Education Act of 1994
AUSA
— Assistant United States Attorney
LOEL
— Lowest Observed Effect Level
ABN
— Advance Beneficiary Notice
DSMICA
— Division of Small Manufacturers, International and Consumer Assistance (FDA)
FORM 348
— Sponsored Travel
CTA
— Clinical Trial Agreement
OS (OC)
— Operations Staff (OC)
CSV
— Comma Separated Values file format
PIC
— Pharmaceutical Inspection Convention
ACS (CBER)
— Analytical Chemistry Staff (Center for Biologics Evaluation and Research)
CO
— Commissioned Officer
PDE
— Permitted Daily Exposure
NLT
— Not Less Than
CA
— Competent Authority
COTA
— Career Opportunities Training Agreement (HHS)
DPS
— Division of Post-marketing Surveillance
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)
TOPRA
— The Organisation for Professionals in Regulatory Affairs
MA
— Marketing Authorization
AAPHP
— American Association of Public Health Physicians
BARDA
— Biomedical Advanced Research and Development Authority
DNCE (CDER)
— Division of Nonprescripton Clinical Evaluation (CDER)
DD (CVM)
— District Director (Center for Veterinary Medicine)
SUBPART H
— That subpart of 21 CFR Part 314 pertaining to accelerated approval of drugs
348
— FDA form for sponsored travel
FSMS
— Food Safety Management System
PEB (CBER)
— Planning and Evaluation Branch (CBER)
IO
— Immediate Office
AMI
— American Meat Institute
ORTF
— Obesity Research Task Force
QL
— Quality of Life
ENTB (CDRH)
— Ear, Nose, and Throat Devices Branch (CDRH)
MUMS ACT
— Minor Use and Minor Species Animal Health Act of 2004
FAN
— Food Allergy Network
OM (CBER)
— Office of Management (Center for Biologics Evaluation and Research)
RSO
— Radiation Safety Officer
OPB (ORA)
— Operations and Policy Branch (Office of Regulatory Affairs)
CDSA
— Controlled Drugs and Substances Act (Canada)
GIF
— Graphics Interchange Format
PUFI
— Packed Under Federal Inspection
NCL
— National Consumers League
X-SCID
— X-linked severe combined immunodeficiency disorder
BPC
— Bulk Pharmaceutical Chemical
ADE/ADER
— Adverse Drug Experience/Adverse Drug Experience Report
FSANZ
— Food Standards Australia New Zealand's
CGTP
— Current Good Tissue Practice
RPMS (OC)
— Regulations Policy and Management Staff (OC)
PNSI
— Prior Notice System Interface
ACP
— Advance Care Planning
CS
— Civil Service
QD
— Quaque in Die (once daily)
IMCC
— Information Management Coordinating Committee
WONF
— With Other Natural Flavors
OSC (CVM)
— Office of Surveillance and Compliance (CVM)
CEB (CFSAN)
— Compliance and Enforcement Branch (CFSAN)
CTDB 2
— Chemistry and Toxicology Devices Branch 2
CHSB (CFSAN)
— Chemical Hazards Science Branch (CFSAN)
CTIA
— Cellular Telecommunications and Internet Association's
ADRAC
— Adverse Drug Reactions Advisory Committee
CTAP
— Career Transition Assistance Plan
QIJ
— Quality Inspection Journal
DP
— Drug Product
IGIV
— Immune Globulin Intravenous
PAI
— Pre-Approval Inspection
CPGM
— Compliance Program Guidance Manual
HHI
— Herth Hope Index
FQPA
— Food Quality Protection Act of 1996
FORM 356V
— New Animal Drug Application
CIB (CFSAN)
— Compliance Information Branch (CFSAN)
CPB (CFSAN)
— Compliance Programs Branch (CFSAN)
COOP
— Continuity of Operations Procedure
ISBT 128
— International Society of Blood Transfusion standard for blood, tissue, and organ identification
TV
— Travel Voucher
ACSM
— American College of Sports Medicine's
DCLD (CDRH)
— Division of Clinical Laboratory Devices (CDRH)
VMO
— Veterinary Medical Officer
FOB
— Federal Office Building
DDES (CFSAN)
— Division of Dairy and Egg Safety (CFSAN)
APTF
— Application Policy Task Force
DCB (CFSAN)
— Domestic Compliance Branch (CFSAN)
OPHEP
— Office of Public Health Emergency Preparedness
FURLS
— FDA Uniform Registration & Listing System
ECT
— Electro-Convulsive Therapy
TTY
— TeleTYpewriter
BFARM
— Bundesinstitut Fur Arzneimittel und Medizinprodukte (German Ministry of Health)
PA
— Physical Activity
GPRD
— General Practice Research Database
CCB (CFSAN)
— Color Certification Branch (CFSAN)
BP
— British Pharmacopoeia
BPL
— Biologic Product License Number
GEBAT
— Government Excess Baggage Authorization Ticket
OIVD (CDRH)
— Office of In Vitro Diagnostic Device Evaluation and Safety (CDRH)
APHL
— Association of Public Health Laboratories
CPID
— Certified Product Information Document (Canada)
SEIU
— Service Employees International Union
ACCME
— Accreditation Council for Continuing Medical Education
BARQA
— British Association of Research Quality Assurance
WMS (OC)
— Website Management Staff (OC)
DIAM (CDRH)
— Division of Imaging and Applied Mathematics (CDRH)
DGSS (CFSAN)
— Division of General Scientific Support (CFSAN)
483
— FDA form used as a written notice of deficiencies found in inspections
CTDB 2 (CDRH)
— Chemistry and Toxicology Devices Branch 2 (CDRH)
CFN
— Central File Number
UFMS
— Unified Financial Management System
RPMCC
— Regulatory Project Management Coordinating Committee (CDER)
BIMO
— bioresearch monitoring
PEB 2 (CDRH)
— Postmarket Evaluation Branch 2 (Center for Devices and Radiological Health)
QMS (CDER)
— Quality Management Staff (CDER)
CHAMPVA
— Civilian Health And Medical Program Of The Department Of Veterans Affairs
RMB (CBER)
— Resource Management Branch (CBER)
BCB (CFSAN)
— Bioanalytical Chemistry Branch (CFSAN)
OIT (OC)
— Office of Information Technology (Immediate Office of the Commissioner)
FLETC
— Federal Law Enforcement Training Center
FERN
— Food Emergency Response Network
OO (CFSAN)
— Office of Operations (CFSAN)
OCP (OC)
— Office of Combination Products (OC)
OEO (OC)
— Office of Executive Operations (OC)
PSSB (CFSAN)
— Program Support Services Branch (CFSAN)
WISQARS
— Web-based Injury Statistics Query and Reporting System
OP 1 (OC)
— Operations Team 1 (OC)
GMID
— Global Market Information Database
DMIP
— Division of Medical Imaging Products (CDER)
USFDA
— United States Food & Drug Administration
VMB (CFSAN)
— Virulence Mechanisms Branch (CFSAN)
BSC
— Biological Safety Cabinet
S&E
— Safety and Effectiveness
ACGME
— Accreditation Council for Graduate Medical Education
CCRC
— Certified Clinical Research Coordinator
WPADP
— Working Party on Automation and Data Processing
FD-1932
— FDA form, Veterinary Adverse Drug Reaction, lack of effectiveness, product defect report - Mandatory
DRB (CBER)
— Devices Review Branch (CBER)
U
— Units
FTE
— Full-Time Equivalent
INADA
— Investigational New Animal Drug Application
TPLC
— Total Product Life Cycle
CIAO
— Critical Infrastructure Assurance Office
BIRAMS
— Biologics Investigational and Related Applications Management System
CRTP
— Clinical Research Training Program
CSO
— Consumer Safety Officer
VVB (CBER)
— Viral Vaccines Branch (CBER)
PAP
— Patient Assistance Program
AIMDD
— Active Implantable Medical Device Directive
CTDB 1
— Chemistry and Toxicology Devices Branch 1
CRMT (OC)
— Cosmetics Toxicology Branch (CFSAN)
ADAA
— Animal Drug Availability Act of 1996
COB (OC)
— Contract Operations Branch (Office of the Commissioner)
FDA-WO
— Food and Drug Administration White Oak campus
ACPM
— American College of Preventive Medicine
OLA (OC)
— Office of Legislative Affairs (Office of the Commissioner)
APIFARMA
— Associação Portuguesa da Indústria FARMAcêutica (Association of the Portuguese Pharmaceutical Industries)
DEB (CFAN)
— Dairy and Egg Branch (CFSAN)
JPMA
— Japan Pharmaceutical Manufacturers Association
QID
— Quater In Die (Four Times a Day)
POB
— Program Operations Branch
RLD
— Reference Listed Drug
NVICP
— National Vaccine Injury Compensation Program
TURBO EIR
— Turbo Establishment Inspection Report (ORA)
CAPLA
— Computer-Assisted Product License Application
BOCB (CFSAN)
— Biological and Organic Chemistry Branch (CFSAN)
OIT (ORA)
— Office of Information Technology (Office of Regulatory Affairs)
CMS
— Centers for Medicare and Medicaid Services (formerly Health Care Financing Administration)
DRF
— Dose Range Findings
PTS (CBER)
— Product Testing Section (CBER)
CHLIA
— chemi-luminescent immunoassay
INV SAMPLE
— INVestigational Sample
SPCS (CDER)
— Safety Policy and Communications Staff (CDER)
FTB (CFSAN)
— Food Technology Branch (CFSAN)
CTEB (CFSAN)
— Cosmetics Technology Branch (CFSAN)
CDISC
— Clinical Data Interchange Standards Consortium (formerly a DIA special interest group called the Clinical Data Interchange Standards Committee)
PEB (ORA)
— Program Evaluation Branch (ORA)
US & R
— urban search and rescue
ER/ES
— Electronic Records/Electronic Signatures
ASRM
— American Society for Reproductive Medicine
ODM
— Operational Data Model
BMB (CFSAN)
— Bioanalytical Methods Branch (CFSAN)
CIS
— Cancer Information Service
ASAS
— American Society of Animal Science
BGH
— Bovine Growth Hormone
DPL
— Drug Product Licensing (Canada)
ACLAM
— American College of Laboratory Animal Medicine
DHC
— dioxin health certificate (ORA AofC code)
CPMP
— Committee for Proprietary Medicinal Products
DDDP (CDER)
— Division of Dermatology and Dental Products (CDER)
SNOMED-RT
— Systematized Nomenclature of Medicine Reference Terminology
IBR (CFSAN)
— Import Branch (CFSAN)
ERB (CFSAN)
— Elemental Research Branch (CFSAN)
PHIN
— Public Health Information Network
NINR
— National Institute of Nursing Research
OSO
— Office of Security Operations
BSC
— Business Service Center
CCP
— Critical Control Point
BVC
— British Veterinary Codex
PFO
— Principal Federal Official
CRB (CBER)
— Clinical Review Branch (CBER)
SECT 505(B)(2)
— New drug application
CE MARK
— CE (Conformite Europeene or European Conformity) marking
RIBAル
— recombinant immunoblot assay (Chiron ᆴ)
FPB (CDRH)
— Field Programs Branch (Center for Devices and Radiological Health)
DRP (CBER)
— Division of Regulations and Policy (CBER)
CAAT
— Center for Alternatives to Animal Testing
DPMU
— Disaster Portable Morgue Unit
FAM
— Foreign Affairs Manual
RU-486
— Roussel Uclaf drug number 486
1932
— FDA form for veterinary adverse drug reaction, lack of effectiveness, product defect report--mandatory
ITS (CBER)
— Information Technology Staff (CBER)
MAD
— Multiple Ascending Dose
VEB (CBER)
— Vaccine Evaluation Branch (CBER)
DTP
— Direct-to-Patient
OVST (CFSAN)
— Operations and Veterinary Support Team (CFSAN)
ELEXNET
— Electronic Laboratory Exchange Network
IMS (CDRH)
— Issues Management Staff (CDRH)
FDARA
— Food and Drug Administration Revitalization Act
SPTPB (CFSAN)
— Seafood Processing and Technology Policy Branch (CFSAN)
PEB (CDRH)
— Program Enforcement Branch (CDRH)
CAPLAR
— Computer-Assisted Product License Application Review
ICCBBA
— International Council for Commonality in Blood Banking Automation, Inc.
GINAD
— Generic Investigational New Animal Drug file
PHPS
— Public Health Prevention Service
LF1
— Low-value Food or Food-related products, level 1 (less than $200)
CC
— Clinical Center
USTR
— United States Trade Representative
CLIA
— Clinical Laboratory Improvement Amendment
SMSB (CFSAN)
— Spectroscopy and Mass Spectrometry Branch (CFSAN)
DUSM
— Deputy United States Marshal (U.S. Department of Justice)
AHIC
— American Health Information Community
ACCP
— American College of Clinical Pharmacology
CMGB (CDER)
— Cae Management and Guidance Branch (CDER)
DEB
— Dairy and Egg Branch
NEDSS
— National Electronic Disease Surveillance System
AAALAC
— Association for the Assessment and Accreditation of Laboratory Animal Care International
DPD (OC)
— Division of Portfolio Development (OC)
PAS (CDRH)
— Premarket Approval Section (CDRH)
DCF
— Data Clarification request Form
PN
— Product Name
ISAC
— Information Sharing and Analysis Center
CUE
— Confidential Unit Exclusion
PQG
— Pharmaceutical Quality Group
PTO
— Patent and Trademark Office (U.S. Department of Commerce)
CFIA
— Canadian Food Inspection Agency
CDA
— Clinical Document Architecture
NCVIA
— National Childhood Vaccine Injury Act of 1986
AIP
— Application Integrity Policy
ASD (HD)
— Assistant Secretary of Defense for Homeland Defense
OS (CDER)
— Operations Staff (CDER)
NDF-RT
— National Drug File Reference Terminology
FDCA
— Federal Food, Drug, and Cosmetic Act of 1938
EFOIA
— Electronic Freedom of Information Act
AER
— Adverse Event Reporting
LOB (ORA)
— Laboratory Operations Branch (ORA)
SC (CDRH)
— Staff College (Center for Devices and Radiological Health)
NOAEL
— No Observable Adverse Effect Level
BIOB (CFSAN)
— Biostatistics Branch (CFSAN)
OSG
— Office of the Surgeon General
VSB (CBER)
— Vaccine Safety Branch (CBER)
MAPCB (CDER)
— Manufacturing Assessment & Pre-Approval Compliance Branch (CDER)
MSU
— Medical Statistics Unit
MSS (CVM)
— Management Support Staff (CDRH)
DMIHP (CDER)
— Division of Medical Imaging and Hematology Products (CDER)
DPEM (ORA)
— Division of Planning, Evaluation and Management (ORA)
DDES
— Division of Dairy and Egg Safety
NCSES
— National Center for Science and Engineering Statistics (NSF)
JTR
— Joint Travel Regulations
OVRR (CBER)
— Office of Vaccines Research and Review (CBER)
PB (CFSAN)
— Pathology Branch (Center for Food Safety and Applied Nutrition)
DDM (NCTR)
— Deputy Director for Management (National Center for Toxicological Research)
CS (OC)
— Communications Staff (OC)
NDE/MIS
— New Drug Evaluation Management Information System
SPR
— System Problem Report
FDC
— Food Drug and Cosmetic
AOAC
— Association of Official Analytical Chemists
GOVTRIP
— government travel website operated by Northrop Grumman
RMS
— Regulatory Management System
NMT
— Not More Than
HNK CELLS
— human neonatal kidney cells
CCFAC
— Codex Committee on Food Additives and Contaminants
ACPE
— Accreditation Council for Pharmacy Education
GDUF
— Generic Drug User Fees
GTL (NCTR)
— Genetic Toxicology Laboratory (NCTR)
STS (CBER)
— Standards and Testing Staff (CBER)
ENG (OC)
— Engineering Team (OC)
SAPB (CFSAN)
— Shellfish and Aquaculture Policy Branch (CFSAN)
GSFA
— General Standard for Food Additives
HFZ
— Headquarters, FDA code Z; mail code for Center for Devices and Radiological Health
CCBC
— Council of Community Blood Centers
SRD
— Swine Respiratory Disease
CFA
— Catfish Farmers of America
BPHC
— Bureau of Primary Health Care
DFO (OC)
— Division of Field Operations (OC)
AMDUCA
— Animal Medicinal Drug Use Clarification Act of 1994
AMG
— ArzeneiMittelGesetz (West Germany drug law)
RAC
— Recombinant-DNA Advisory Committee
PMOA
— Primary Mode Of Action
ACB (CDRH)
— Accreditation and Certification Branch (CDRH)
OM (CVM)
— Office of Management (Center for Veterinary Medicine)
ACC
— RCHSA (Radiation Control for Health and Safety Act) ACCession number
MAPP
— Manual of Policy and Procedures
ACE
— Automated Commercial Environment (US Customs)
SCSB (CFSAN)
— Scientific Computer Support Branch (CFSAN)
PBSC
— Peripheral Blood Stem Cell
POA
— privately owned automobile
GRASE
— Generally Recognized As Safe and Effective
LESTD (CBER)
— Laboratory of Enteric and Sexually Transmitted Diseases (CBER)
DCGM (OC)
— Division of Contracts and Grants Management (OC)
HAM/TSP
— HTLV-I-associated myelopathy / tropical spastic paraparesis
FASS
— Federation of Animal Science Societies
DRARD (CDRH)
— Division of Reproductive, Abdominal and Radiological Devices (CDRH)
OP 4 (OC)
— Operations Team 4 (OC)
PAHO
— Pan American Health Organization
PPE
— Pay Period Ending
FCO
— Federal Coordinating Officer (in disaster areas)
DSORD
— Division of Surgical, Orthopedic, and Restorative Devices
RAC
— Raw Agricultural Commodity
SUPAC
— Scale-Up and Postapproval Changes
C & R
— corrections and removals
HCCN
— Health Center-Controlled Network
NAION
— non-arteritic anterior ischemic optic neuropathy
DMIRDP (CDER)
— Division of Medical Imaging and Radiopharmaceutical Drug Products (CDER)
FCRDC
— Frederick Cancer Research and Development Center
IUO
— investigation use only
BDR
— Budget Data Request
DES
— Drug Eluting Stent
SOAB (OC)
— Systems and Office Automation Branch (Immediate Office of the Commissioner)
OHRMS
— Office of Human Resources and Management Services
TPP
— Target Product Profile
TO
— Transportation Officer
CTEP
— Cancer Therapy Evaluation Program
QBR
— Question-Based Review
ACLAD
— American Committee on Laboratory Animal Diseases
OEL
— Occupational Exposure Level
MB (CFSAN)
— Microanalytical Evaluations Branch of the Center for Food Safety and Applied Nutrition
HHS SERT
— Health and Human Services Secretary's Emergency Response Team
IFIC
— International Food Information Council
CCST (CFSAN)
— Clinical Chemistry Support Team (CFSAN)
MIRA
— Medicare Innovation Responsiveness Act of 2003
BRMD
— Bureau of Radiation and Medical Devices
EDRLS
— Electronic Drug Registration and Listing Systems
FEDRIP
— FEDeral Research In Progress Database
OP 3 (OC)
— Operations Team 3 (OC)
CBIAC
— Chemical and Biological Defense Information Analysis Center
OCI (ORA)
— Office of Criminal Investigations (ORA)
RODS
— Real-Time Outbreak & Disease Surveillance System
TEPRSSC
— Technical Electronic Product Radiation Safety Standards Committee
PDCS
— Policy Development and Coordination Staff
ECS (OC)
— Economics Staff (OC)
CFSAN
— Center for Food Safety and Applied Nutrition
ºº
— sections û shorthand symbol used to designate sections in a legal document; as in ºº201(m), 301(k) o
ADCOM
— ADvisory COMmittee
DAAS
— Division of Aging and Adult Services
FDAMA
— Food and Drug Administration Modernization Act of 1997
PAITS
— Pre-Approval Inspection Tracking System
AT (OC)
— Acquisitions Team (OC)
M2
— ICH M2 Expert Working Group (EWG) [electronic standards for transmission of regulatory information]
EML
— Environmental Measurement Laboratory
GEMCRIS
— Genetic Modification Clinical Research Information System (NIH)
PPQ
— Plant Protection and Quarantine
DIOP (ORA)
— Division of Import Operations and Policy (ORA)
SL
— Signature Line
ACLA
— American Clinical Laboratory Association
GOVCC
— government travel charge card
EVS (OC)
— Evaluation Staff (OC)
AFIP
— Armed Forces Institute of Pathology (DoD)
ELS
— Establishment License Supplement
CAPRA
— Canadian Association of Professional Regulatory Affairs
VCRP
— Voluntary Cosmetic Registration Program
AB (CDRH)
— Analysis Branch (CDRH)
USBR
— Bureau of Reclamation (U.S. Department of the Interior)
CAFDAS
— Committee for the Advancement of FDA Science
WAE
— When Actually Employed
EDIFACT
— Electronic Data Interchange for Administration, Commerce, and Transportation
DMARDS
— disease-modifying antirheumatic drug
NEP
— National Exercise Program
DDMAC (CDER)
— Division of Drug Marketing, Advertising and Communication (CDER)
EUP
— Experimental Use Permit
USITC
— United States International Trade Commission
WPS (OC)
— Workforce Programs Staff (OC)
DCRMS (CDER)
— Division of Compliance Risk Management and Surveillance (CDER)
FDERA
— Food and Drug Export Reform and Enhancement Act of 1996
CMCCC
— Chemistry and Manufacturing Controls Coordinating Committee
COSTART
— Coding Symbols for Thesaurus of Adverse Reaction Terms
OPPL (OC)
— Office of Policy, Planning and Legislation (OC)
OCS
— Office of the Chief of Staff
LCDC
— Laboratory Centre for Disease Control
PPT
— Plasma Preparation Tube
EMOPS (OC)
— Office of Emergency Operations (OC)
QSR
— Quality System Record
NNMC
— National Naval Medical Center
ITB (CFSAN)
— Immunotoxicology Branch (CFSAN)
TRX
— Total number of Prescriptions
IDR
— Idiosyncratic Drug Reaction
IDBD
— Infectious Disease Biomarker Database
ASCPT
— American Society for Clinical Pharmacology and Therapeutics
OCER (CDRH)
— Office of Communication, Education and Radiological Programs (CDRH)
PERT
— Product-enhanced Reverse Transcriptase
OSHC (OC)
— Office of Science and Health Coordination (OC)
ABIFARMA
— Brazilian Association of the Pharmaceutical Industry
NCPDP
— National Council for Prescription Drug Programs
COP
— Coastal Ocean Program
WIN
— Welfare Information Network
DCRER (CFSAN)
— Division of Chemistry Research and Environmental Review (CFSAN)
GCPB II (CDER)
— Good Clinical Practice Branch II (CDER)
DESE (CDRH)
— Division of Electrical and Software Engineering (CDRH)
ADEC
— Australian Drug Evaluation Committee
OER (OC)
— Office of External Relations (OC)
DMETS (CDER)
— Division of Medical Errors and Technical Support (CDER)
BLS
— Biologics License Supplement
DNPL (CFSAN)
— Division of Nutrition Programs and Labeling (Center for Food Safety and Applied Nutrition)
OCOD
— Office of Communication Outreach and Development (CBER)
DHRD (ORA)
— Division of Human Resources Development (ORA)
PCBE
— President's Council on Bioethics
RAE
— Remedial Action Exemption
MVB (CFSAN)
— Molecular Virology Branch (CFSAN)
COOP
— Continuity of Operations Policy
FDAS
— Defense Finance and Accounting Services
ICLAS
— International Council for Laboratory Animal Science
NMDP
— National Marrow Donor Program
HFEB (CDRH)
— Human Factors Engineering Branch (CDRH)
DMPQ (CDER)
— Division of Manufacturing and Product Quality (CDER)
3RS
— Recruitment and Relocation Bonuses and Retention Allowances
IB (CFSAN)
— Immunobiology Branch (CFSAN)
3500
— FDA form for voluntary reporting of adverse events
AHFS
— American Hospital Formulary Service
BGMA
— British Generic Manufacturers Association
GCSL (CFSAN)
— Gulf Coast Seafood Laboratory (Dauphin Island, Alabama) (CFSAN)
NSR
— Non-Significant Risk
OITSS (OC)
— Office of Information Technology Shared Services (Immediate Office of the Commissioner)
ANCOVA
— Analysis of Covariance
ALJ (OC)
— Office of the Administrative Law Judge (OC)
REMS
— Risk Evaluation and Mitigation Strategy
HBOT
— Hyperbaric Oxygen Therapy
DFEM (NCTR)
— Division of Facilities Engineering and Maintenance (NCTR)
MPEG
— Moving Pictures Experts Group
RAC
— Reviewer Affairs Committee
IMDB (CDRH)
— Immunology and Molecular Diagnostics Devices Branch (CDRH)
OVST
— Operations and Veterinary Support Team
NTB (CFSAN)
— Neurotoxicology Branch (CFSAN)
DPEB (CBER)
— Division of Planning, Evaluation and Budget (CBER)
ICD-9-CM
— International Classification of Diseases, Ninth Revision, Clinical Modification
ACMP
— American College of Medical Physics
PP
— Pay Period
NMI
— Non-Medicinal Ingredient
FFRM
— Food Facility Registration Module (FURLS)
RCHSA
— Radiation Control for Health and Safety Act of 1968
NACHO
— National Association of County Health Officials
OARSA
— Office of Applied Research and Safety Assessment
OMT
— Oral Mucosal Transudate
DMPQ (CBER)
— Division of Manufacturing and Product Quality (CBER)
OSHI (OC)
— Office of Special Health Issues (OC)
GRP
— Good Review Practice
SHEMS
— Safety, Health, and Environmental Management Section
RADAR
— Risk Assessment of Drugs Analysis and Response
RMCC
— Review Management Coordinating Committee
COTT
— Committee Of Ten Thousand
LWC
— Lead Wire or patient Cable
DEIO (ORA)
— Division of Emergency and Investigational Operations (ORA)
NATAG
— North American Technical Advisory Group
RIBAÖ
— recombinant immunoblot assay (Chiron «)
TOA
— Total Obligation Authority
VRBPAC
— Vaccines and Related Biological Products Advisory Committee
MOC
— Management and Operations Council
DMEPA (CDER)
— Division of Medical Error Prevention and Analysis
QOD
— Quaque Altere Die (take every other day)
ADE
— Adverse Drug Event
NEMA
— National Emergency Management Association
PNC
— Prior Notice Center
NIFC
— National Interagency Fire Center
PEP
— Performance Evaluation Plan
EB (NCTR)
— Engineering Branch (NCTR)
COOP
— Continuity of Operations Program
PICNIC
— Professionals and Citizens Network for Integrated Care
ESRA
— European Society of Regulatory Affairs
SBA
— Summary Basis of Approval
FOP
— Financial Operating Plan
JMO
— Japanese Maintenance Organization
NOEL
— no observed effect level
DMST (CFSAN)
— Division of Market Studies (CFSAN)
3R
— Recruitment, Relocation bonuses, and Retention allowances
ECDT
— Electronic Common Technical Document
USFS
— United States Forest Service (U.S. Department of Agriculture)
CEB (CDER)
— Clinical Evaluation Branch (CBER)
GCPB I (CDER)
— Good Clinical Practice Branch I (CDER)
DCCA (CBER)
— Division of Communication and Consumer Affairs (CBER)
SUD
— Sudden Unexpected Death
LNC
— Labeling and Nomenclature Committee
SMCC
— Standards Management Coordinating Committee
DOED (CDRH)
— Division of Ophthalmic, Ear, Nose and Throat Devices (CDRH)
ASC
— Advertising Standards Council
BC/BS
— Blue Cross and Blue Shield
WRAIR
— Walter Reed Army Institute of Research
AMPI
— Associated Milk Producers Inc.
DPFRM (CFSAN)
— Division of Planning and Financial Resources Management (CFSAN)
OPPB
— Office of Policy Planning and Budget
IPOAB (CDRH)
— Information Processing and Office Automation Branch (CDRH)
UADE
— Unanticipated Adverse Device Event
OOPD
— Office of Orphan Product Development (FDA)
DEMO (CDRH)
— Division of Ethics and Management Operations (CDRH)
CFR
— Contract Financial Requirements
AVEG
— AIDS Vaccine Evaluation Group
TDDS
— Transdermal Drug Delivery System
SPCS
— Safety Policy and Communications Staff
UNAIDS
— Joint United Nations Program on HIV/AIDS
BMBL
— Biosafety in Microbiological and Biomedical Laboratories
AIMBE
— American Institute For Medical and Biological Engineering
FASA
— Federal Acquisition Streamlining Act (of 1994)
COOP
— Continuity of Operations Project
FMB
— Financial Management Branch
DMT (CVM)
— Division of Manufacturing Technologies (CVM)
FD-483
— FDA form, Written Notice of Deficiencies Found in Inspections
MITA
— Medicaid Information Technology Architecture
CABP
— Community-Acquired Bacterial Pneumonia
MRB (CFSAN)
— Methods Research Branch (Center for Food Safety and Applied Nutrition)
CND (CDRH)
— Cardiovascular/Neurological Devices Branch (CDRH)
DD
— Division Director
HFS
— Headquarters, FDA Safety; mail code for Center for Food Safety and Applied Nutrition
TSA
— Transportation Security Administration
COTB (CBER)
— Communication Technology Branch (CBER)
ODE III
— Office of Drug Evaluation III (CDER)
CTTI
— Clinical Trials Transformation Initiative
CMGB
— Cae Management and Guidance Branch
NALBOH
— National Association of Local Boards of Health
BDB
— Biologic Devices Branch (CBER)
ABRA
— American Blood Resource Association
CSPI
— Center for Science in the Public Interest
EPMS
— Employee Performance Management System
356V
— FDA form for new animal drug appication
DRC (CVM)
— Division of Residue Chemistry (CVM)
MIS (OC)
— Management Initiatives Staff (OC)
OPS (CDER)
— Office of Pharmaceutical Science (CDER)
CNPP
— USDA Center for Nutrition Policy and Promotion
OGUD (CDRH)
— Obstetrics and Gynecology Devices Branch (CDRH)
IMLS
— Institute of Museum and Library Services
ANADA
— Abbreviated New Animal Drug Application
LRIT (CFSAN)
— Labeling Regulations Implementation Team (CFSAN)
AIMS
— Agency Information Management System
CIB
— Clinical Investigator's Brochure
ISMP
— Institute for Safe Medication Practices
RR
— repeatedly reactive
MUMS
— Minor Use and Minor Species Animal Health Act of 2004
COCB
— Communication and Coordination Branch
CMMI
— Center for Medicare and Medicaid Innovation
BID
— Bis In Die (Twice Daily)
DTBIMP (CDER)
— Division of Therapeutic Biological Internal Medicine Products (CDER)
TBSB (CBER)
— Therapeutics and Blood Safety Branch (CBER)
ADRP
— Association of Donor Recruitment Professionals
JRIES
— Joint Regional Information Exchange System
HCPCS
— HCFA (Health Care Financing Administration) Common Procedure Coding System
DDMAC
— Division of Drug Marketing, Advertising, and Communications
GTIB (CBER)
— Gene Transfer and Immunogenicity Branch (CBER)
EOS (CDER)
— Executive Operations Staff (CDER)
DSI (CDER)
— Division of Scientific Investigation (CDER)
ADMIA
— Associate Director for Medical and International Affairs
MMAB (CFSAN)
— Microbiological Methods Application Branch of the Center for Food Safety and Applied Nutrition
DCIQA (ORA)
— Division of Compliance Information and Quality Assurance (ORA)
OCM (OC)
— Office of Crisis Management (OC)
OES (OC)
— Office of Executive Secretariat (OC)
DIAM
— Division of Imaging and Applied Mathematics
CMHS
— Center for Mental Health Services
AFAB
— Absorbable Fibrin Adhesive Bandage
SOCRA
— Society of Clinical Research Associates
EMAC
— Emergency Management Assistance Compact
GTB (CBER)
— Gene Therapies Branch (CBER)
DVR
— Deviation Variance Report
DEPI (CBER)
— Division of Ethics and Program Integrity (CBER)
CIQI
— Clinical Investigator Qualification Information
FORM 483
— Written Notice Of Deficiencies Found In Inspections
CTS
— Correspondence Tracking System
NIDRR
— National Institute on Disability and Rehabilitation Research
DDI (CDER)
— Division of Drug Information (CDER)
DTD (CDER)
— Division of Training and Development (CDER)
IRMC
— Information Resources Management College
DATS
— Document Accountability and Tracking System
PSNI
— Pharmaceutical Society of Northern Ireland
DIVBT (CFSAN)
— Division of In Vitro and Biochemical Toxicology (CFSAN)
DMEP (CDER)
— Division of Metabolism and Endocrinology Products (CDER)
LST
— LiSTing number of a device
DBEC (OC)
— Division of Budget Execution and Control (OC)
HAZOP
— HAZard and OPerability analysis
ORP (CFSAN)
— Office of Regulations and Policy (Center for Food Safety and Applied Nutrition)
HDC
— High-Dose Chemotherapy
FSPS (ORA)
— Federal-State Program Staff (ORA)
SIREN
— Scientific Information Retrieval and Exchange Network (CFSAN)
ELINCS
— European List of Notified Chemical Substances
TRAC
— Tolerance Reassessment Advisory Committee
GSDB (CDRH)
— General Surgery Devices Branch (CDRH)
BHPR
— Bureau of Health Professions
RBC
— Red Blood Cells
MMDB (CFSAN)
— Microbial Methods Development Branch (CFSAN)
DSP (OC)
— Division of Strategic Projects (OC)
SMDA
— Safe Medical Devices Act of 1990
CSB (OC)
— Customer Support Branch (Office of the Commissioner)
DEPI
— Division of Ethics and Program Integrity
DFPP (CFSAN)
— Division of Food Processing and Packaging (Chicago, Illinois) (CFSAN)
ADRM (CBER)
— Associate Director for Review Management (CBER)
ITDS
— International Trade Data System
ROC
— receiver operating characteristic curve
SDM
— System Development Methodology
IIG
— Inactive Ingredient Guide
CTTB (CBER)
— Cellular and Tissue Therapy Branch (CBER)
OCIO (OC)
— Office of the Chief Information Officer (OC)
PMF
— Public Master File
FCIC
— Federal Consumer Information Center
FQHC
— Federally-Qualified Health Center
HTM
— Health Technical Memorandum
NINDS
— National Institute of Neurological Disorders and Stroke
USP-NF
— United States Pharmacopeia-National Formulary
ONPLDS (CFSAN)
— Office of Nutritional Products, Labeling and Dietary Supplements (CFSAN)
TSD (OC)
— Travel Services Division (OC)
LBVB
— Laboratory of Biochemistry and Vascular Biology
EIND
— Electronic Investigational New Drug Application (US Food and Drug Administration)
AO
— Administrative Officer
DC III (CDER)
— Division of Chemistry III (CDER)
FTCA
— Federal Trade Commission Act
LF2
— Low-value Food or Food-related products, level 2 (between $200 and $500)
FEDROOMS
— Federal Premier Lodging Program
DRMP (CDER)
— Division of Review Management and Policy (CDER)
ODE I
— Office of Drug Evaluation I (CDER)
FLQ
— Fluoroquinolone
COFEPRIS
— Comisi�n Federal para la Protecci�n contra Riesgos Sanitarios (Federal Commission for the Protection Against Sanitary Risks) (Mexico)
ACRA (ORA)
— Associate Commissioner for Regulatory Affairs (ORA)
MDII
— Medical Device Innovation Initiative
GHDB (CDRH)
— General Hospital Devices Branch (CDRH)
ARDB (CDRH)
— Anesthesiology and Respiratory Devices Branch (CDRH)
NRCC
— National Response Coordination Center
BI
— Boehringer Ingelheim
EHPAS (NCTR)
— Environmental Health and Program Assurance Staff (NCTR)
DPD (CVM)
— Division of Production Drugs (CVM)
BSA
— Broad-Spectrum Antibiotic
CET (CFSAN)
— Clinical Evaluation Team (Center for Food Safety and Applied Nutrition)
BDB (CDRH)
— Bacteriology Devices Branch (CDRH)
CBRA
— California Biomedical Research Association
DPPS (CFSAN)
— Division of Plant Product Safety (CFSAN)
EBPDR
— electronic biological product deviation reporting
ORM (ORA)
— Office of Resource Management (ORA)
TID
— three times a day
DGRND (CDRH)
— Division of General, Restorative and Neurological Devices (CDRH)
DRV
— Daily Reference Value
ES
— Effect Size
MPCC
— Medical Policy Coordinating Committee
SC (CFSAN)
— Staff College (Center for Food Safety and Applied Nutrition)
IDL
— International Date Line
DDOP (CDER)
— Division of Drug Oncology Products (CDER)
ACOL
— Acceptable Carry-Over Limit
ARAB (OC)
— Accounting Reports and Analysis Branch (OC)
OFM (OC)
— Office of Financial Management (OC)
NST
— National Support Team
FORM 3500
— Voluntary Reporting of Adverse Events
MPQA
— Medical Products Quality Assurance
ICCVAM
— Inter-agency Coordinating Committee on Validation of Alternative Methods
ODE IV (CDER)
— Office of Drug Evaluation IV (CDER)
LRSP (CBER)
— Laboratory of Respiratory and Special Pathogens (CBER)
PCBS
— polychlorinated biphenyls
OTS (CDER)
— Office of Translational Sciences (CDER)
NPCC
— National Poison Control Center
OSDB (CDRH)
— Orthopedic Spine Devices Branch (CDRH)
CSB (ORA)
— Customer Support Branch (Office of Regulatory Affairs)
DRUP (CDER)
— Division of Reproductive and Urologic Products (CDER)
MMRB (CFSAN)
— Microbiological Methods Research Branch (CFSAN)
DFCN (CFSAN)
— Division of Food Contact Notifications (CFSAN)
DCTD (CDRH)
— Division of Chemistry and Toxicology Devices (CDRH)
DPQR (CDER)
— Division of Product Quality Research (CDER)
DIO (OC)
— Division of Infrastructure Operations (OC)
BMS
— Broadcast Media Staff
WTA
— WITHHOLDING TAX ALLOWANCE
DETTD (CBER)
— Division of Emerging and Transfusion Transmitted Diseases (CBER)
OIASI (OC)
— Office of International Activities and Strategic Initiatives (OC)
DCRP (CDER)
— Division of Cardiovascular and Renal Products (CDER)
DBM (CDRH)
— Division of Bioresearch Monitoring (CDRH)
IDBR
— Infectious Disease Board Review
CBRG
— Cancer Biomarkers Research Group
FD-1932A
— FDA form for veterinary adverse drug reaction, lack of effectiveness, product defect report - voluntary
ACIL
— A national trade asociation representing independent, commerical scientific, and engineering firms (formerly the American Council of Independent Laboratories)
AEA
— Actual Expense Allowance
WRAMC
— Walter Reed Army Medical Center
DVRPA (CBER)
— Division of Vaccines and Related Product Applications (CBER)
IAN
— International Approved Names for pharmacopoeial substances
DCMO (ORA)
— Division of Compliance Management and Operations (ORA)
BOS-DO (ORA)
— Boston (Massachusetts) District Office (ORA)
CDP
— Career Development Plan
LMD (CBER)
— Laboratory of Method Development (CBER)
FIC
— John E. Fogarty International Center
DES (OC)
— Division of Engineering Services (Immediate Office of the Commissioner)
SOP
— Standard Operating Procedure
DPC-PTR ACT
— Drug Price Competition and Patent Trade Restoration Act of 1984
CCFL
— Codex Committee on Food Labeling
FEGLI
— Federal Employees Group Life Insurance
ICSR
— Individual Case Safety Report
ITCB (OC)
— Information Technology Contracts Branch (OC)
DNP (CFSAN)
— Division of Natural Products (Center for Food Safety and Applied Nutrition)
DIRM (CFSAN)
— Division of Information Resources Management (CFSAN)
LVCH
— Local VouCHer
BTCB (CBER)
— Blood and Tissue Compliance Branch (CBER)
FDOT (CFSAN)
— Food Defense Oversight Team (CFSAN)
COCB (CFSAN)
— Communication and Coordination Branch (CFSAN)
ITGS (OC)
— IT Governance Staff (OC)
NMQAAC
— National Mammography Quality Assurance Advisory Committee
DCSC (OC)
— Division of Construction and Service Contracts (OC)
ARDB
— Anesthesiology and Respiratory Devices Branch
BTR
— Blood and Tissue Registration System
AASA
— Aging and Adult Services Administration
OIP (OC)
— Office of International Programs (OC)
R&E
— Recall and Emergency
DETTD
— Division of Emerging and Transfusion Transmitted Diseases
ONCHIT
— Office of the National Coordinator for Health Information Technology
ADER
— Adverse Drug Experience Report
OND (CDER)
— Office of New Drugs (CDER)
DUPSA (CDRH)
— Division of Device User Programs and System Analysis (CDRH)
ITACS
— Import Trade Auxiliary Communication System
ONDQA (CDER)
— Office of New Drug Quality Assessment (CDER)
DB II (CDER)
— Division of Biometrics II (CDER)
DB III (CDER)
— Division of Biometrics III (CDER)
ODE II
— Office of Drug Evaluation II (CDER)
PELT (CFSAN)
— Product Evaluation and Labeling Team (CFSAN)
DDM (OC)
— Division of Dockets Management (OC)
BAH
— Booz-Allen & Hamilton
UNOS
— United Network for Organ Sharing
NHRIC
— national health related items code (CDRH)
IVDS
— in-vitro diagnostic devices
LHV (CBER)
— Laboratory of Hepatitis Viruses (CBER)
ICE
— Immigration and Customs Enforcement (Department of Homeland Security)
DDMS (CDER)
— Division of Database Management and Services (CDER)
DVP (CBER)
— Division of Viral Products (CBER)
NEEP
— National Exercise and Evaluation Program
NTA
— Notice to Applicants
LRA
— Local Registration Authority
NCIPC
— National Center for Injury Prevention and Control (CDC)
FCLAA
— Federal Cigarette Labeling and Advertising Act of 1965
ONADE (CVM)
— Office of New Animal Drug Evaluation (CVM)
FORM 1932
— Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report - Mandatory
ATPA
— American Technology Pre-eminence Act of 1991
FMB (CDRH)
— Financial Management Branch (CDRH)
VCJD
— Variant Creutzfeldt-Jakob Disease
APBI
— Association of the British Pharmaceutical Industry
HFES
— Human Factors and Ergonomics Society's
CSPDB
— Circulatory Support and Prosthetic Devices Branch
OCTEC (CDER)
— Office of Counter-terrorism and Emergency Coordination (CDER)
DRARD
— Division of Reproductive Abdominal and Radiological Devices
GWQAP
— Government Wide Quality Assurance Program
RMAB (CDRH)
— Risk Management and Analysis Branch (CDRH)
EOS
— End of Study
OP 1
— Operations Team 1
PARN
— Problem/Action Request Notice
DDB (CDRH)
— Diagnostic Devices Branch (Center for Devices and Radiological Health)
DLPS (CDER)
— Division of Labeling and Program Support (CDER)
ASIA
— American Sheep Industry Association
OS (CFSAN)
— Office of Seafood (CFSAN)
TERMIS
— Tissue Engineering and Regenerative Medicine International Society
AMB (CDRH)
— Adminstrative Management Branch (CDRH)
MEO
— Most Efficient Organization (Navy)
NOMI
— Federation of Norwegian Pharmaceutical Manufacturers
OPD (OC)
— Office of Orphan Products Development (OC)
SB (ORA)
— Systems Branch (ORA)
RPMB (CBER)
— Regulatory Project Management Branch (CBER)
LNE
— Laboratoire National de Metrologie et d'Essias (National Laboratory of Metrology and Essays)
FHB
— Food and Health Bureau
NFPA
— National Food Processors Association
OSAS (CFSAN)
— Office of Scientific Analysis and Support (CFSAN)
FTIM
— first time in man
FIS
— Field Information System
CGS (ORA)
— Contract and Grants Staff (ORA)
JMPR
— Joint FAO-WHO Meeting of Pesticide Residues
DCEPT (CBER)
— Division of Clinical Evaluation and Pharmacology/Toxicology (CBER)
BISTI
— Biomedical Information Science and Technology Initiative
CPI
— Critical Path Institute
MACPAC
— Medicaid and CHIP Payment and Access Commission
DIMS (CFSAN)
— Data Information Management Staff (CFSAN)
DSFM (CDRH)
— Division of Solid and Fluid Mechanics (CDRH)
MDB (CFSAN)
— Methods Development Branch (CFSAN)
CODB (CDRH)
— Cardiovascular and Ophthalmic Devices Branch (CDRH)
NSV-DO (ORA)
— Nashville (Tennessee) District Office (ORA)
HAD
— Hospital Anxiety and Depression scale
OPT (OC)
— Office of Pediatric Therapeutics (OC)
CIPP
— Critical Infrastructure Protection Program
CCHIT
— Certification Commission for Healthcare Information Technology
DPDFS (CFSAN)
— Division of Plant and Dairy Food Safety (CFSAN)
PVDB (CDRH)
— Peripheral Vascular Devices Branch (CDRH)
NASS
— National Agricultural Statistics Service
IDE (CDRH)
— Investigational Device Exemptions Sections (CDRH)
OPA (OC)
— Office of Public Affairs (OC)
OIT (CFSAN)
— Office of Information Technology (Center for Food Safety and Applied Nutrition)
MHSB (CFSAN)
— Microbial Hazards Science Branch (CFSAN)
ORADSS
— Office of Regulatory Affairs Reporting, Analysis, and Decision Support System
LDV (CBER)
— Laboratory of DNA Viruses (CBER)
EPIA
— Egg Products Inspection Act
MDCN
— Medicare Data Communication Network
IREAS (CDRH)
— International Relations and External Affairs Staff (CDRH)
JIFSAN
— Joint Institute for Food Safety and Applied Nutrition
CSS (CDER)
— Controlled Substance Staff (CDER)
CVM
— Center for Veterinary Medicine (Food & Drug Administration)
INDC
— Investigational New Drug Committee
CEMB (CDRH)
— Cardiac Electrophysiology and Monitoring Devices Branch (CDRH)
QU
— Quality Unit
DBA (CBER)
— Division of Blood Applications (CBER)
EOFP
— electronic Official Personnel File
DBOP (CDER)
— Division of Biologic Oncology Products (CDER)
DFPG (CFSAN)
— Division of Field Programs and Guidance (CFSAN)
CDUS
— Clinical Data Update System (NCI)
OPF
— Official Personnel Folder
OSE (CDER)
— Office of Surveillance and Epidemiology (CDER)
NHIC
— National Health Information Center
ACTB (NCTR)
— Analytical Chemical Techniques Branch (NCTR)
DPQ (CBER)
— Division of Product Quality (CBER)
DBPAP (CBER)
— Division of Bacterial, Parasitic and Allergenic Products (CBER)
QSI
— Quality Step Increase
KMT (OC)
— Knowledge Management Staff (OC)
C&R
— Corrections and Removals
ACUS
— Administrative Conference of the United States
IPPIA
— International Plasma Products Industry Association
TFM
— Tentative Final Monograph
NPCR
— National Program of Cancer Registries
DPE (CDER)
— Division of Post-marketing Development (CDER)
WNET
— Women's Network for Entrepreneurial Training
DNDLC (CDER)
— Division of New Drugs and Labeling Compliance (CDER)
SCARP
— Supplier Corrective Action Report
HISPC
— Health Information Security and Privacy Collaboration
DFLSC (CFSAN)
— Division of Food Labeling, Standards, and Compliance (CFSAN)
CI/KR
— Critical Infrastructure and Key Resources
COMAH
— Control Of Major Accident Hazards Regulation of 1999
IIMB (CDRH)
— IT Infrastructure Management Branch (CDRH)
DRUP
— Division of Reproductive and Urologic Products
SMB (OC)
— Space Management Branch (OC)
CAERS
— CFSAN (Center for Food Safety and Applied Nutrition) Adverse Event Reporting System
ILINET
— Influenza-like Illness Surveillance Network
DB V (CDER)
— Division of Biometrics V (CDER)
WL
— Warning Letter (most serious Food & Drug Administration postaudit letter; demands immediate action within 15 days)
FPBR (CFSAN)
— Food Packaging Branch (Chicago, Illinois) (CFSAN)
CBE
— Changes Being Effected
CRIX
— Clinical Research Information Exchange
DSCI (OC)
— Division of Systems, Compliance and IMPAC (OC)
DC I (CDER)
— Division of Chemistry I (CDER)
DLS
— Document Logging System
CCVDF
— Codex Committee on Veterinary Drugs in Foods
IMB (CDRH)
— Information Management Branch (CDRH)
DPEPOS (CFSAN)
— Division of Programs and Enforcement Policy (OS) (CFSAN)
OGD (CDER)
— Office of Generic Drugs (CDER)
NTL
— National Testing Laboratory
DCP 3 (CDER)
— Division of Clinical Pharmacology 3 (CDER)
ICPEMC
— International Commission for Protection against Environmental Mutagens and Carcinogens
DTBOP (CDER)
— Division of Therapeutic Biological Oncology Products (CDER)
MFC
— Model Food Code
DBRA (NCTR)
— Division of Biometry and Risk Assessment (NCTR)
SAS
— Symptom Assessment Scale
OBA
— Office of Biotechnology Activities
ACRA
— Associate Commissioner for Regulatory Affairs (Food & Drug Administration)
CFO (OC)
— Chief Financial Officer (OC)
EORTC
— European Organisation for Research and Treatment of Cancer
UCB
— umbilical cord blood cells
CAERST (CFSAN)
— CFSAN Adverse Event Reporting System Team
ICB (CFSAN)
— Implementation and Compliance Branch (CFSAN)
LPET (CFSAN)
— Laboratory Proficiency and Evaluation Team (CFSAN)
NAA
— National Aquaculture Association
GOCO
— government-owned contractor-operated
NSAPE
— North American Society for Pacing and Electrophysiology
GPHA
— Generic Pharmaceutical Association
DBGNR (CFSAN)
— Division of Biotechnology and GRAS Notice Review (CFSAN)
MARCS
— Mission Accomplishment and Regulatory Compliance Services System (ORA)
LMV (CBER)
— Laboratory of Molecular Virology (CBER)
BRB
— Biometric Research Branch
ICDR
— Interagency Committee on Disability Research
DCCT (CFSAN)
— Division of Color Certification and Technology (CFSAN)
MUMS (CVM)
— Office of Minor Use and Minor Species (CVM)
NBAC
— National Bioethics Advisory Commission (replaced By PCBE; Archived At GU)
FNH
— Febrile Non-Hemolytic reaction
DPS (CDRH)
— Division of Post-marketing Surveillance (CDRH)
NONS
— Notification of New Substance Regulations 193 (EC)
DSST (CFSAN)
— Division of Seafood Science and Technology (CFSAN)
CFBR
— Center for Biologics Research
DMS (OC)
— Division of Management Systems (OC)
TE
— Therapeutic Equivalence
FPET (CFSAN)
— Food Processing Evaluation Team (CFSAN)
DPDD (CDER)
— Division of Pediatric Drug Development (CDER)
BPCA
— Best Pharmaceuticals for Children Act of 2002
SADR
— Suspected Adverse Drug Reaction
SORN
— System of Records Notices
CARTS
— CFSAN (Center for Food Safety and Applied Nutrtition) Automated Research Tracking System
NRTE
— Not Ready-To-Eat
CPG
— Compliance Policy Guide
DB I (CDER)
— Division of Biometrics I (CDER)
ANOC
— Annual Notice of Changes
ITTT
— Information Technology Training Team
DODP (CDER)
— Division of Oncologic Drug Products (CDER)
DPA I
— Division of Pre-marketing Assessment I
NPPC
— National Pork Producers Council
ASB (OC)
— Accounting Services Branch (OC)
TIACC
— Therapeutic Inequivalence Action Coordinating Committee
FICEMS
— Federal Interagency Committee on Emergency Medical Services
BIRA
— British Institute of Regulatory Affairs
ADRA
— Administrative Dispute Resolution Act
CAO
— Change of Appointing Office
CCOHTA
— Canadian Coordinating Office for Health Technology Assessment
AB
— Analysis Branch
DOE B (CDRH)
— Division of Enforcement B (CDRH)
ONP (CDER)
— Office of Nonprescription Products (CDER)
LVBD (CBER)
— Laboratory of Vector-Borne Diseases (CBER)
CSREES
— Cooperative State Research, Education, and Extension Services
CCST
— Clinical Chemistry Support Team
INAD
— Investigational New Animal Drug
IDIQ
— indefinite-delivery, indefinite-quantity [contracts]
BST
— Bovine Somatotropin
DESE
— Division of Electrical and Software Engineering
EDQM
— European Directorate for the Quality of Medicines
SDAB (CDER)
— Surveillance and Data Analysis Branch (CDER)
GATT
— General Agreement of Tariffs and Trade
FT (OC)
— Financial Team (OC)
GPEA
— Government Paperwork Elimination Act
OODP (CDER)
— Office of Oncology Drug Products (CDER)
HLGT
— high level group term
HERG
— human ether-a-go-go gene
LR2
— Low-value non-prescription Radiation-emitting products, level 2 (between $200 and $1000)
DDI
— Division of Drug Information
MEFA
— Foreningen Af MEdicinfabrikanter
CPDF
— Central Personnel Data File (OPM)
CISET
— Committee on International Science Engineering and Technology
SMS
— Standards Management Staff (CDRH)
DP (NCTR)
— Division of Planning (National Center for Toxicological Research)
DDOM (CBER)
— Division of Disclosure and Oversight Management (CBER)
DES (CVM)
— Division of Epidemiology and Surveillance (Center for Veterinary Medicine)
CMO
— Contract Management Organization
HAI
— Health Action International
IPRMS (OC)
— International Planning and Resource Management Staff (OC)
SSB
— Systems Support Branch
FARM
— Food Additives Regulatory Management System
OEP (CDER)
— Office of Executive Programs (CDER)
FPB (CFSAN)
— Field Programs Branch (Center for Food Safety and Applied Nutrition)
DDPS
— Detailed Description of the Pharmacovigilance System
ISB (CDRH)
— Inspection Support Branch (CDRH)
CCID
— Coordinating Center for Infectious Diseases
MERS-TM
— Medical Event Reporting System - Transfusion Medicine
GRN
— Generally Recognized as Safe Notification
OCTMA (CBER)
— Office of Communication, Training and Manufacturers Assistance (CBER)
DMQRP (CDRH)
— Division of Mammography Quality and Radiation Programs (CDRH)
SDWA
— Safe Drinking Water Act (as amended in 1986)
GILS
— Government Information Locator Service
DFM (NCTR)
— Division of Financial Management (NCTR)
MSS (CDRH)
— Management Support Staff (Center for Devices and Radiological Health)
DCP (ORA)
— Division of Compliance Policy (ORA)
CFG
— Center for Functional Genomics
BRMS
— Biologics Regulatory Management System
CES (CFSAN)
— Consumer Education Staff (Center for Food Safety and Applied Nutrition)
GADPTRA
— Generlc Animal Drug and Patent Term Restoration Act
DTNPS (CFSAN)
— Division of Toxicology and Nutrition Product Studies (CFSAN)
ALL
— Adult Acute Lymphocytic Leukemia
NBDRC
— National Blood Data Resource Center
SID
— schedule identifier number (ORA AofC code)
WNV
— West Nile Virus
IVTB (CFSAN)
— In Vitro Toxicology Branch (CFSAN)
DSDB (CDRH)
— Diagnostic and Surgical Devices Branch (CDRH)
OB-GYN
— Obstetrics-Gynecology
EEPS
— Electronic Entry Processing System
EHSB
— Environmental Health Services Branch
DRM (OC)
— Division of Resource Management (OC)
BIND
— Biological Investigational New Drug
CST (CFSAN)
— Consumer Studies Team (CFSAN)
TIND
— Treatment Investigational New Drug
HPAA
— Health Policy and Administration
NVPO
— National Vaccine Program Office
CDCP
— Centers for Disease Control and Prevention
EMEA
— European Medicines Agency (formerly European Medicines Evaluation Agency)
AND
— Abbreviated New Drug application number
INNS
— International Neural Network Society
DGRT (NCTR)
— Division of Genetic and Reproductive Toxicology (NCTR)
DDSPC (CFSAN)
— Division of Dietary Supplement Programs and Compliance (CFSAN)
RADAR
— Radio Detecting and Ranging
ADR
— Adverse Drug Report
NME
— New Molecular Entity
GLPBB (CDER)
— Good Laboratory Practices and Bioequivalence Investigations Branch (CDER)
DARPA
— Defense Advanced Research Projects Agency (DoD)
LCT (CFSAN)
— Labeling Compliance Team (CFSAN)
OIT (CDRH)
— Office of Information Technology (Center for Devices and Radiological Health)
DPIC (CFSAN)
— Division of Pesticides and Industrial Chemicals (CFSAN)
DRGUD
— Division of Reproductive, Gastrorenal and Urology Devices (CDRH)
OIA (OC)
— Office of Internal Affairs (OC)
DB IV (CDER)
— Division of Biometrics IV (CDER)
DRAT (CFSAN)
— Division of Research and Applied Technology (CFSAN)
DDDP
— Division of Dermatology and Dental Products
OFSDO (CFSAN)
— Office of Food Safety, Defense and Outreach (CFSAN)
DTDNFA (CVM)
— Division of Therapeutic Drugs for Non-food Animals (CVM)
DB VI (CDER)
— Division of Biometrics VI (CDER)
NADE
— New Animal Drug Evaluation
ORL-DO (ORA)
— ORLando District Office (Office of Regulatory Affairs)
RESNA
— Rehabilitation Engineering and Assistive Technology Society of North America
EHRP
— Enterprise Human Resources and Payroll System
FPLP
— Federal Premier Lodging Program
DFARS
— Drug Firm Annual Registration Status
DDMSS (CDER)
— Division of Data Management Services and Solutions (CDER)
MRRA (CFSAN)
— Microbial Research and Risk Assessment Staff (CFSAN)
BLST (CFSAN)
— Building and Laboratory Services Team (CFSAN)
ALFB (CBER)
— Acess Litigation and FOI Branch (CBER)
OSEL (CDRH)
— Office of Science and Engineering Laboratories (CDRH)
RMS/BLA
— Regulatory Management System for the Biologics License Application
ASICS
— Application Specific Integrated Circuits
GDEA
— Generic Drug Enforcement Act of 1992
APSB (OC)
— Accounting Policy and Systems Branch (OC)
RDB (CDRH)
— Radiological Devices Branch (CDRH)
MPAB (OC)
— Management Programs and Analysis Branch (OC)
DP (CDRH)
— Division of Physics (Center for Devices and Radiological Health)
ACS
— Automated Commercial System
GPRA
— Government Performance Results Act of 1993
EOP2
— End-Of-Phase 2
AIIS
— Analogous Industrial Injuries Scheme
BUF-DO (ORA)
— Buffalo (New York) District Office (ORA)
NDRMMP
— National Drug Residue Milk Monitoring Program
BACPAC
— Bulk ACtivities Post-Approval Changes
DCP 5 (CDER)
— Division of Clinical Pharmacology 5 (CDER)
CCFICS
— Codex Committee on Food Import and Export Certification and Inspection Systems
DFRM
— Drug Facility Registration Module (FURLS)
DPAP (CDER)
— Division of Pulmonary and Allergy Products (CDER)
CAC
— Carcinogenicity Assessment Committee
NDAB
— National Drugs Advisory Board
ORD
— Office of Research and Demonstrations
ORO
— Office of Regional Operations
EPD (CDRH)
— Electronic Product Devices Branch (CDRH)
AE
— Approvable, but not yet approved
LBP (CBER)
— Laboratory of Bacterial Polysaccharides (CBER)
EUCOMED
— EUropean COnfederation of MEDical Devices Associations
OIT (CVM)
— Office of Information Technology (Center for Veterinary Medicine)
HQO
— Home Quarantine Order
OPMAD (CDRH)
— Orthopedic Physical Medicine and Anesthesiology Devices Branch (CDRH)
GCPP (OC)
— Good Clinical Practice Program (OC)
FDAAA
— Food and Drug Administration Amendments Act
ORPS (OC)
— Office of Real Property Services (OC)
LEAA
— Law Enforcement Alliance of America
ARL (ORA)
— Arkansas Regional Laboratory (ORA)
GRC
— Gerontology Research Center
SAD
— Single Ascending Dose
LCH (CBER)
— Laboratory of Cellular Hematology (CBER)
HTRB (CBER)
— Human Tissue and Reproduction Branch (CBER)
ACTIS
— AIDS Clinical Trials Information Service
FD-2301
— FDA form, Transmittal of Periodic Reports and Promotional Material for New Animal Drugs
NDMS (CDER)
— New Drug Microbiology Staff (CDER)
BT
— Bacillus thuringiensis Berliner
DIMS (OC)
— Division of Infrastructure Management and Services (OC)
DEPI (CDER)
— Division of Epidemiology (CDER)
ORO (ORA)
— Office of Regional Operations (ORA)
NMPF
— National Milk Producers Federation
PMB
— Program Management Board
HITSP
— Health Information Technology Standards Panel
ASLAP
— American Society of Laboratory Animal Practitioners
SGO
— Surgeon General's Office
ISASS (OC)
— International Scientific Activities and Standards Staff (OC)
DSATOS (CFSAN)
— Division of Science and Applied Technology (OS) (CFSAN)
EOS (ORA)
— Executive Operations Staff (ORA)
AED
— anti-epileptic drug
ECRS (CFSAN)
— Emergency Coordination and Response Staff (CFSAN)
ONLDS (CFSAN)
— Office of Nutrition, Labeling and Dietary Supplements (CFSAN)
DTDFA (CVM)
— Division of Therapeutic Drugs for Food Animals (CVM)
FPVST (OC)
— Facilities Planning and Voice Services Team (OC)
LMDQC (CBER)
— Laboratory of Methods Development and Quality Control (CBER)
LRPDB (CDRH)
— Labeling Research and Policy Development Branch (CDRH)
ITSO
— Information Technology Services Officer
OIASI
— Office of International Activities and Strategic Initiatives
DRP II (CDER)
— Division of Regulatory Policy II (CDER)
CC/RVDF
— Codex Committee on Residues of Veterinary Drugs in Foods
FHA
— Federal Health Architecture
DPA II (CDER)
— Division of Pre-marketing Assessment II (CDER)
IMB
— Irish Medicines Board
RUG
— Resource Utilization Group
VISB (OC)
— Visual Information Services Branch (OC)
DCP 2 (CDER)
— Division of Clinical Pharmacology 2 (CDER)
TVBB (CBER)
— Tumor Vaccines and Biotechnology Branch (CBER)
DGP (CDER)
— Division of Gastroenterology Products (CDER)
WSL (CFSAN)
— Washington Seafood Laboratory (CFSAN)
IPOAB
— Information Processing and Office Automation Branch
IPEC
— International Pharmaceutical Excipients Council
NNC
— National Notification Center
FLSS (CFSAN)
— Food Labeling and Standards Staff (CFSAN)
406B
— Section of the FDA Modernization Act dealing with getting feedback from our stakeholders
CCPR
— Codex Committee on Pesticide Residues
ACE
— Adverse Clinical Event
GCC
— Government Coordinating Council of the Food and Agriculture Sector
NCBDDD
— National Center on Birth Defects and Developmental Disabilities
GRDB (CDRH)
— Gastroenterology and Renal Devices Branch (CDRH)
ELIPS
— Electronic Labeling Information Processing System
IV & V
— independent verification and validation
APEC
— Asia-Pacific Economic Cooperation Council
DPA I (CDER)
— Division of Pre-marketing Assessment I (CDER)
SR
— Sustained-Release
LRN
— Laboratory Response Network
ADRM
— Associate Director for Review Management
DMAT (CBER)
— Division of Manufacturers Assistance and Training (CBER)
RFCPCS (CFAN)
— Retail Food and Cooperative Programs Coordination Staff (CFSAN)
OSO (OC)
— Office of Security Operations (OC)
FLTCIP
— Federal Long Term Care Insurance Program
ESS (CBER)
— Executive Secretariat Team (CBER)
ULDB (CDRH)
— Urology and Lithotripsy Devices Branch (CDRH)
TPDS
— Training and Professional Development Staff
CGMPR
— Current Good Manufacturing Practices Regulations
SDWIS
— Safe Drinking Water Information System
OFAS (CFSAN)
— Office of Food Additive Safety (CFSAN)
NAHC
— National Advisory Health Council
SNRI
— Serotonin-Norepinephrine Reuptake Inhibitor
FAAN
— Food Allergy and Anaphylaxis Network
BOP
— Boards Of Pharmacy
CCRA
— Clinical Contract Research Association
IPRO
— Independent Pharmaceutical Research Organization
DDOM
— Division of Disclosure and Oversight Management
CDDI
— Collaboration for Drug Development Improvement
DSRCS (CDER)
— Division of Surveillance, Research and Communication Support (CDER)
BIMS
— Biologic IND (Investigational New Drug) Management System
LATS
— License Application Tracking System
NFSS
— National Food Safety System
DPHB (CFSAN)
— Division of Public Health and Biostatistics (CFSAN)
OTCOM (CDER)
— Office of Training and Communications (CDER)
FORM 1932A
— Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report - Voluntary
UKCCR
— United Kingdom Coordinating Committee on Cancer Research
QTV
— Qualified Through Verification
MSAB (CFSAN)
— Manufacturing and Storage Adulteration Branch (CFSAN)
SSRCR
— Suggested State Regulations for Control of Radiation
ATPM
— Association of Teachers and Preventive Medicine
SPA
— Special Protocol Assessment
S/C
— Servings per Container
RFDD
— Regional Food and Drug Director
ADMIA (CBER)
— Associate Director for Medical and International Affairs (CBER)
VEDB (CDRH)
— Vitreal and Extraocular Devices Branch (CDRH)
RPS (CDER)
— Regulatory Policy Staff (CDER)
NBCS
— National Biomedical Computer System
DCIA
— Debt Collection Act of 1996
CSPDB (CDRH)
— Circulatory Support and Prosthetic Devices Branch (CDRH)
DRP I (CDER)
— Division of Regulatory Policy I (CDER)
DPEB
— Division of Planning, Evaluation, and Budget
FSIS
— Food Safety and Inspection Service
IFMFS (CFSAN)
— Infant Formula and Medical Foods Staff (CFSAN)
OTRR (CBER)
— Office of Therapeutics Research and Review (CBER)
OFACS
— Office of Facilities, Acquisitions and Central Services
AFC
— Adult Foster Care
DAIDS
— Division of AIDS (NIAID)
VSS (NCTR)
— Veterinary Services Staff (NCTR)
DHFS (CVM)
— Division of Human Food Safety (CVM)
LECC
— Law Enforcement Coordination Committee
OSS (OC)
— Office of Shared Services (OC)
SISCF/SIFCF
— Survey of Inmates of State and Federal Correctional Facilities
IBB (CFSAN)
— Instrumentation and Biophysics Branch (CFSAN)
PAFA
— Priority-Based Assessment of Food Additives
RMS (CDER)
— Review Management Staff (CDER)
DNRD
— Division of Nonprescription Regulation Development
SCRAG
— Senior Civilian Representative of the Attorney General, Department of Homeland Security
ORPSS (CFSAN)
— Office of Regulations, Policy and Social Sciences (CFSAN)
ET (CFSAN)
— Education Team (CFSAN)
OCP (CDER)
— Office of Clinical Pharmacology (CDER)
EMBS
— Engineering in Medicine and Biology Society (IEEE)
OEEODEM (OC)
— Office of EEO and Diversity Management (OC)
OFDCER (CFSAN)
— Office of Food Defense, Communication and Emergency Response (CFSAN)
SUDS
— Single-Use Devices
IRS (OC)
— International Relations Staff (OC)
PDQ
— physician data query information from national cancer institute
CENELEC
— Comite Europeen de Normalisation Electrotechnique (European Committee for Electrotechnical Standardization)
DIT (NCTR)
— Division of Information Technology (National Center for Toxicological Research)
AS (CVM)
— Administrative Staff (CVM)
GRAS/E
— Generally Recognized As Safe and Effective
LCP (CDER)
— Laboratory of Clinical Pharmacology (CDER)
RDI
— Reference Daily Intake
CTB (CBER)
— Cell Therapies Branch (CBER)
SIMT
— Scientific, Internet/Intranet and Middle Tier (CFSAN)
RSMB (CDRH)
— Reporting Systems Monitoring Branch (CDRH)
DRFDD (ORA)
— Deputy Regional Food and Drug Director (ORA)
C3I
— communications, command, control, and intelligence
LM
— Listeria monocytogenes
LMDCI (CBER)
— Laboratory of Mycobacterial Diseases and Cellular Immunology (CBER)
FMLA
— Family and Medical Leave Act of 1993
RIAS
— Regulatory Impact Analysis Statement
COMSTAT
— COMpliance STATus Information System
EES
— Establishment Evaluation System
DPEM
— Division of Planning, Evaluation, and Management
BPB (CBER)
— Blood and Plasma Branch (CBER)
CSG
— Counterterrorism Security Group
NCER
— Non-Conformance Escalation Report
CSAT
— Center for Substance Abuse Treatment (SAMHSA)
OSD-HD
— Office of the Secretary of Defense for Homeland Defense
PDE-4
— PhosphoDiEsterase-4
NCFST
— National Center for Food Safety & Technology
FPA
— Food Products Association
DRM (CDER)
— Division of Records Management (CDER)
ACB
— Accreditation and Certification Branch
DAVP (CDER)
— Division of Anti-viral Products (CDER)
TGA
— Therapeutic Goods Administration (Australia)
CTX
— Clinical Trials Exemption
DIS (CDER)
— Division of Information Services (CDER)
FEDGLOBE
— Gay, Lesbian, Bisexual, Transgender Employees of the Federal Government
BDSS
— Biologics Decision Support System
OND
— Office of New Drugs
VOAD
— Volunteer Organizations Active in a Disaster
FRDTS
— Federal Register Document Tracking System
DCM (CDRH)
— Division of Communications Media (CDRH)
DCP 4 (CDER)
— Division of Clinical Pharmacology 4 (CDER)
HPO
— High Performance Organization
ASPER
— Assistant Secretary for Personnel
INFARMED
— Instituto Nactional da FARMaciae e do MEDicamento (Portugal)
PHTN
— Public Health Training Network
CCOP
— Community Clinical Oncology Program
OP 4
— Operations Team 4
DDRE
— Division of Drug Risk Evaluation
COS (CFSAN)
— Cosmetics Staff (CFSAN)
NGFA
— National Grain and Feed Association
DBE (CDER)
— Division of Bioequivalence (CDER)
IFAD
— International Food Additives Database
IOM
— Investigation Operations Manual
AMT
— Asset Management Team
CERCLIS
— Comprehensive Environmental Response, Compensation and Liability Information System (EPA)
ADAM
— Analysis Dataset Model
NCAB
— National Cancer Advisory Board
CEDR
— Comprehensive Epidemiologic Data Resource (U.S. Department of Energy)
APR
— Annual Product Review
CPS
— Compendium of Pharmaceuticals and Specialties
DIS (CBER)
— Division of Inspections and Surveillance (CBER)
DCD (CDRH)
— Division of Cardiovascular Devices (CDRH)
DPAF
— Division of Planning, Analysis, and Finance
BIG
— Blacks In Government
AMT (OC)
— Asset Management Team (OC)
ARNET
— Acquisition Reform Network
NWK-DO (ORA)
— Newark District Office (ORA)
NOOH
— Notice Offering an Opportunity for a Hearing
SDCID
— Study Data Common Issues Document
DMB (CFSAN)
— Division of Molecular Biology (CFSAN)
OSB (CDRH)
— Office of Surveillance and Biometrics (CDRH)
DMSO
— chloroform/2-propanol/dimethylsulfoxide
OST (CFSAN)
— Office Services Team (CFSAN)
DCT (CDER)
— Division of Counter-terrorism (CDER)
SMPS (CDRH)
— Standards Management Program Staff (CDRH)
AHI
— Animal Health Institute
AOPC
— Agency/Organization Program Coordinator
EEO (NCTR)
— Equal Employment Opportunity Staff (NCTR)
CS (CVM)
— Communications Staff (CVM)
DFPST (CFSAN)
— Division of Food Processing Science and Technology (CFSAN)
HCTERS
— Human Cell and Tissue Establishment Registration System
ECRI
— Emergency Care Research Institute (no longer uses name initials only)
ADSA
— Aging and Disability Services Administration
TAS (NCTR)
— Technology Advancement Staff (NCTR)
DCMS (CDRH)
— Division of Chemistry and Material Science (CDRH)
OMP (CDER)
— Office of Medical Policy (CDER)
DER
— Drug Experience Report
NOAA
— National Oceanographic and Atmospheric Administration (U.S.)
BWM
— basic workload measurement
NSE
— Not Substantially Equivalent
DVA (CFSAN)
— Division of Virulence Assessment (CFSAN)
DIDP (CBER)
— Division of Information Disclosure Policy (CDER)
DPP (CDER)
— Division of Psychiatry Products (CDER)
OB
— Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)
DC (NCTR)
— Division of Chemistry (NCTR)
ASHRAE
— American Society of Heating, Refrigeration & Air Conditioning Engineers
IMB (CDER)
— Interface Management Branch (CDER)
OPPL
— Office of Policy, Planning, and Legislation
CHII
— Consolidated Health Informatics Initiative
REG NEG
— regulatory negotiation
CDTL
— Cross Discipline Team Leader
DMB (CDER)
— Division of Management and Budget (CDER)
TBP
— Therapeutic Biologic Product
MSTD
— Materials Science and Technology Department
SPIE
— International Society for Optical Engineering
MMRB
— Microbiological Methods Research Branch
DC II (CDER)
— Division of Chemistry II (CDER)
DHS
— Department of Homeland Security (U.S.)
DVPS (CVM)
— Division of Veterinary Product Safety
QOS
— Quality Overall Summary
SITP 5A8(OC)
— Strategic IT Programs (OC)
ICIB (CDRH)
— Intraocular and Corneal Implants Branch (CDRH)
CM
— Committee Meeting
RSB (CDER)
— Review Support Branch (CDER)
FPIF
— Finnish Pharmaceutical Industry Association
DPAMS (CDER)
— Division of Pre-marketing Assessment III and Manufacturing Science (CDER)
TDDB (CDRH)
— Television Design and Development Branch (CDRH)
DRMO (CDRH)
— Division of Risk Management Operations (CDRH)
MGB (CFSAN)
— Molecular Genetics Branch (CFSAN)
BACON
— Bacterial CONtamination
DS (CVM)
— Division of Surveillance (CVM)
ACWA
— Administrative Careers With America
PDLB (CDRH)
— Pacing, Defibrillator and Leads Branch (CDRH)
CP
— Compliance Program
OFFAS (OC)
— Office of Field Financial and Acquisitions Services (OC)
FPVST
— Facilities Planning and Voice Services Team
EIS (OC)
— Ethics and Integrity Staff (OC)
NE-FO (ORA)
— Regional Field Office, Northeast Region
WOC II
— Woodmont Office Complex II (South)
NOAE
— no observed adverse effect
AICRC
— Association of Independent Clinical Research Contractors
PTC
— Parklawn Training Center
IQA
— Institute of Quality Assurance (UK)
DCC (OC)
— Division of Customer Care (OC)
BCE
— Beneficial Clinical Event
LMS
— LABORATORY MANAGEMENT SYSTEM
MTOS (CFSAN)
— Muirkirk Technical Operations Staff (CFSAN)
DBEPA (CBER)
— Division of Blood Establishment and Product Applications (CBER)
REE
— Research, Education, and Economics
CDRS (CFSAN)
— Case Development and Recall Staff (CFSAN)
BMIS
— Bioresearch Monitoring Information System
OSCI (CFSAN)
— Office of Science (CFSAN)
IIMG
— Interagency Incident Management Group
SECT 406B
— FDA Modernization Act section dealing with getting feedback from stakeholders
SIB (CDRH)
— Special Investigations Branch (CDRH)
HCDB (CDRH)
— Hematology and Cytology Devices Branch (CDRH)
SUPAC-MR
— scale-up and postapproval changes--modified release
OMS (CFSAN)
— Office of Management Systems (CFSAN)
ERSB (CFSAN)
— Emergency Response and Surveillance Branch (CFSAN)
ESS (NCTR)
— Executive Secretariat Staff (NCTR)
RAA
— Research Across America (various locations)
DEC (CFSAN)
— Division of Education and Communication (CFSAN)
ANRC
— American National Red Cross
DTP (CDER)
— Division of Therapeutic Proteins (CDER)
CEN
— Comite Europeen de Normalisation (European Committee for Standardization)
COPTRG
— Community Oncology and Prevention Trials Research Group (NCI)
ADRA
— Associate Director of Regulatory Affairs
MT (CFSAN)
— Medical Team (CFSAN)
NIDR
— National Institute of Dental Research (see NIDCR)
NASAR
— National Association of Search and Rescue
BSE
— bovine spongiform encephalopathy (mad cow disease)
BEQ
— bioequivalence
ABE
— Adverse Biologic Experience
CFOI
— Census of Fatal Occupational Injuries
CM
— Case Management
DIO (CBER)
— Division of Information Operations (CBER)
NVSS
— National Vital Statistics System
EREA
— Export Reform and Enhancement Act of 1996
R&W
— Recreation and Welfare
OIRA
— Office of Information & Regulatory Affairs
PAER
— Preliminary Adverse Event Report
NPRM
— Notice of Proposed Rulemaking
CONSER
— Cooperative Online Serials
ABLES
— Adult Blood Level Epidemiology & Surveillance
NTF
— National Turkey Federation
ASD(HD)
— Assistant Secretary of Defense for Homeland Defense
IOTF
— Interagency Oncology Task Force
CARS
— Compliance Achievement Reporting System
LPT (CFSAN)
— Liaison and Policy Team (CFSAN)
DRB
— Devices Review Branch
NSRT
— Nutrition Science Review Team
NEFLE
— National Exchange for Food Labeling Education
OCTMA
— Office of Communication, Training and Manufacturers Assistance
SN/AEMS
— Special Nutritional Adverse Events Monitoring System
LERN
— Library Electronic Reference Network
ISBT
— International Society of Blood Transfusion
VMAC
— Veterinary Medicine Advisory Committee
FEHBP
— Federal Employees Health Benefits Program
ANA
— Abbreviated New Animal drug number
OPFIT (NCTR)
— Office of Planning, Finance and Information Technology (NCTR)
VCTB (CBER)
— Vaccine Clinical Trials Branch (CBER)
CRIS
— Clinical Research Information System (NIH)
SUPEC
— Scale-Up and Post-Approval Changes
FGIS
— Comisión Federal para la Protección contra Riesgos Sanitarios (Federal Commission for the Protection Against Sanitary Risks) (Mexico)
DHT (CBER)
— Division of Human Tissues (CBER)
VDB (CDRH)
— Virology Devices Branch (CDRH)
HP
— High Potency
DM (NCTR)
— Division of Microbiology (NCTR)
RSGEMS (CFSAN)
— Regulations and Special Government Employees Management Staff (CFSAN)
OCI
— Office of Criminal Investigations (FDA)
DVS (CBER)
— Division of Veterinary Services (CBER)
MVT (CFSAN)
— Molecular Virology Team (CFSAN)
MMSB (CFSAN)
— Molecular Methods and Subtyping Branch (CFSAN)
CSA
— Clinical Study Agreement
DMA (CDER)
— Division of Monoclonal Antibodies (CDER)
DSDB
— Diagnostic and Surgical Devices Branch
BCP
— Bureau of Consumer Protection
PPIA
— Poultry Products Inspection Act
DEOD (CDRH)
— Dental, Ear, Nose, Throat and Ophthalmic Devices Branch (CDRH)
BRMAC
— Biological Response Modifiers Advisory Committee
HBOC
— hemoblogin-based oxygen carrier
MATTB (CBER)
— Manufacturers Assistance and Technical Training Branch (CBER)
OIT (NCTR)
— Office of Information Technology (National Center for Toxicological Research)
TOR
— Threshold of Regulation
NCWM
— National Conference on Weights and Measures
CUVP
— Committee for Veterinary Medicinal Products (EMEA)
OCO (CFSAN)
— Office of Constituent Operations (CFSAN)
HTLV-III
— human lymphotropic virus, type III (AIDS agent, HIV)
OD (CDER)
— Office of the Center Director (CDER)
IPCB (CDER)
— Investigations and Preapproval Compliance Branch (CDER)
IIFAR
— Incurably Ill for Animal Research
NRB
— Noninstitutional Review Board
NAGC
— National Association of Government Communicators
NPSB (CFSAN)
— Nutritional Product Studies Branch (CFSAN)
RFPT (CFSAN)
— Retail Food Protection Team (CFSAN)
DMAT
— Division of Manufacturers Assistance and Training
CHI
— Consolidated Health Initiative
NARMS
— National Antimicrobial Resistance Monitoring System
LASA
— Linear Analog Self-Assessment measure
SDE
— State Designated Entity
FORCG
— Foodborne Outbreak Response Coordinating Group
GMA
— Grocery Manufacturers Association's
IAVG
— Interagency Vaccine Group
ADRS
— Adverse Drug Reporting System
ACEC
— Autism Centers of Excellence Program (NIH)
S&I
— Standards and Interoperability
ICB (CDRH)
— Inspection and Compliance Branch (CDRH)
OVI
— Organic Volatile Impurity
OCTGT (CBER)
— Office of Cellular, Tissue and Gene Therapies (CBER)
LH (CBER)
— Laboratory of Hemostasis (CBER)
CDR
— Central Document Room
HARTS
— Hoechst Adverse Reaction Terminology System
ADUFA
— Animal Drug User Fee Act of 2003
OHSC
— OCCUPATIONAL HEALTH and SAFETY CENTRE
BPB
— Blood and Plasma Branch
NCPHI
— National Center for Public Health Informatics (CDC)
PTCC
— Pharmacology and Toxicology Coordinating Committee
TAVC
— total aerobic viable count
ATS (CDER)
— Applied Technologies Staff (CDER)
SOC
— System Organ Classes
FWP
— Federal Women's Program
OPDFB (CFSAN)
— Office of Plants, Dairy Foods and Beverages (CFSAN)
DCP 1 (CDER)
— Division of Clinical Pharmacology 1 (CDER)
JLCS (OC)
— Jefferson Laboratory Complex Staff (OC)
FDAGLOBE
— Gay, Lesbian, Bisexual, Transgender Employees of the Federal Government within FDA
AGA
— Association of Government Accounts
LR (CBER)
— Laboratory of Retroviruses (CBER)
MFRPS
— Manufactured Food Regulatory Program Standards
ELDU
— Extra-Label Drug Use
MAS CELL
— manipulated autologous structural cell
NCID
— National Center for Infectious Diseases (CDC)
RES
— Residence
EIDE
— Electronic Investigational Device Exemption
USOPM
— United States Office of Personnel Management
V/V
— Verification/Validation
CPSA
— Consumer Product Safety Act
USAMRIID
— U.S. Army Medical Research Institute for Infectious Diseases
DBCP (CBER)
— Division of Blood Collection and Processing (CBER)
OTCDHFB (CDER)
— OTC Drugs and Health Fraud Branch (CDER)
LIR (CBER)
— Laboratory of Immunoregulation (CBER)
CSI
— Consumer Safety Inspector
IBE
— individual bioequivalence
CDDTB (CBER)
— Career Development and Directed Training Branch (CBER)
BEST
— Biomonitoring of Environmental Status and Trends (Biological Resources Division, USGS)
BAC
— Billing Agency Code
CASPER
— Center Automated System Process Exchange and Reporting
LPD (CBER)
— Laboratory of Plasma Derivatives (CBER)
NICCL
— National Incident Communications Conference Line
DCGT (CBER)
— Division of Cell and Gene Therapies (CBER)
ITATMT (OC)
— IT Asset Tracking and Management Team (OC)
IAST (CFSAN)
— International Activities Staff (CFSAN)
PDS (CDER)
— Project Development Staff (CDER)
DBT (NCTR)
— Division of Biochemical Toxicology (NCTR)
HCTRS
— Human Cell and Tissue Establishment Registration System (usually seen as HCTERS)
PDUFA
— Prescription Drug User Fee Act of 1992
VCH
— Travel VouCHer claim
OTR (CDER)
— Office of Testing and Research (CDER)
DSMICA (CDRH)
— Division of Small Manufacturers, International and Consumer Assistance (CDRH)
DQRS
— Drug Quality Reporting System
NAD
— NED Animal Drug number
ADWOH
— Average Day's Work On Hand
AF
— Administrative File
SBREFA
— Small Business Regulatory Enforcement Fairness Act
IFU
— Instructions For Use
PAG
— Project Advisory Group
CBSC
— Cord Blood Stem Cells
NHF
— National Hemophilia Foundation
BSB (CFSAN)
— Biotechnology Studies Branch (Chicago, Illinois) (CFSAN)
EPT (CFSAN)
— Epidemiology Team (CFSAN)
DSM
— Data Standards Manual
DPFRM
— Division of Planning and Financial Resources Management
EDRG
— Early Detection Research Group
DSPTP (CDER)
— Division of Special Pathogen and Transplant Products (CDER)
EEO (CFSAN)
— Equal Employment Opportunity Office (CFSAN)
DMD (CDRH)
— Division of Microbiology Devices (CDRH)
HSIN
— Homeland Security Information Network
ITC
— International Trade Commission
DRA (CFSAN)
— Division of Risk Assessment (CFSAN)
SISTIR
— Strategic Information Systems Technical Integration Resources
AMA
— Agricultural Marketing Act of 1946
CEPPO
— Chemical Emergency Preparedness and Prevention Office (EPA)
DPR (CFSAN)
— Division of Petition Review (CFSAN)
NCNR
— National Center for Nursing Research (NIH)
MERCOSUR
— MERcado COmún del SUR (Southern Common Market)
DSRIT (CFSAN)
— Dietary Supplement Regulations Implementation Team (CFSAN)
MSQA
— Mammography Quality Standards Act of 1992
LTSS
— Long-Term Services and Supports
VATS
— Viral Activation Transfusion Study
USAN
— United States Adopted Name
DPA II
— Division of Pre-marketing Assessment II
DRISK (CDER)
— Divison of Risk Management (CDER)
FES (OC)
— Financial Enterprise Solutions (OC)
CERTS
— Centers for Education and Research on Therapeutics (DHHS)
TPCC
— Therapeutic Products Classification Committee
LRS
— Lot Release System
DRR (NCTR)
— Deputy Director for Research (NCTR)
DMS (CFSAN)
— Division of Microbiological Studies (CFSAN)
NVTB (CFSAN)
— Neurotoxicological and In Vitro Toxicology Branch (CFSAN)
AOB
— Accounting Operations Branch
CAN
— Common Accounting Number
MSI
— Magnetic Source Imaging
MEDSA
— Medicine Equity and Drug Safety Act of 2000
ALFB
— Access Litigation and FOI (Freedom Of Information) Branch
CABIG
— Cancer Biomedical Informatics Grid (NIH)
APSB
— Accounting Policy and Systems Branch
DPS (CFSAN)
— Division of Program Services (CFSAN)
ASB
— Administrative Services Branch
DEEM
— Dietary Exposure Evaluation Model (Durango Software LLC)
RRHR
— Regional Radiological Health Representative
RACC
— Reference Amount Customarily Consumed
BSC
— Blood Safety Committee
OSB (CFSAN)
— Office Services Branch (CFSAN)
RRS
— Resource Reporting System
RMT (CFSAN)
— Regulations Management Team (CFSAN)
SUPEC-IR
— Scale-Up and Post-Approval Changes - Instant Release
SCRRB (ORA)
— Scientific Compliance and Regulatory Review Branch (ORA)
CADSR
— Cancer Data Standards Repository
MHPF
— Minority Health Professionals Foundation
BPWG
— Business Process Working Group
BDPA
— Bureau of Drug Policy and Administration (China)
UCUM
— Unified Codes for Units of Measure (Regenstrief Institute)
DE (CBER)
— Division of Epidemiology (CBER)
CBCTN
— Community-Based Clinical Trials Network
UDI
— Unique Device Identification
OMO (CDRH)
— Office of Management Operations (CDRH)
DRAT
— Division of Research and Applied Technology
SSE
— Summary of Safety and Effectiveness
MNVP
— Medically Necessary Veterinary Product
CI
— Clinical Investigator
RPB (CDRH)
— Radiation Programs Branch (CDRH)
DC (CVM)
— Division of Compliance (CVM)
NPS (CFSAN)
— Nutrition Programs Staff (CFSAN)
CDP
— Candidate Development Program
RTL (NCTR)
— Reproductive Toxicology Laboratory (NCTR)
DCP (NCTR)
— Division of Contracts and Procurement (NCTR)
DTBE
— Division of Tuberculosis Elimination
EB (CDRH)
— Epidemiology Branch (CDRH)
OMP (OC)
— Office of Management Programs (OC)
B&F
— Budget and Finance
LBPUA (CBER)
— Laboratory of Bacterial, Parasitic and Unconventional Agents (CBER)
CABE
— corrective action(s) being effected
AGRICOLA
— AGRICultural On-Line Access
DFOI (OC)
— Division of Freedom of Information (OC)
OGC
— Office of the General Counsel (DHHS)
NDIRS (CFSAN)
— New Dietary Ingredients Review Staff (CFSAN)
SPGC
— Standards and Practice Guidelines Committee
NOP
— National Organic Program
MEDSUN
— Medical Product Safety Network
APA
— Administrative Procedures Act
RIS (CBER)
— Retroviral Immunology Section (CBER)
SRS (CDER)
— Science and Research Staff (CDER)
DNRD (CDER)
— Division of Nonprescription Regulation Development (CDER)
EPO
— European Patent Office
NRP-CIS
— National Response Plan Catastrophic Incident Supplement
GTIS
— Gene Therapy Information System
CHISSA
— Center for High Integrity Software System Assurance
CTP
— Center for Tobacco Products
HRRC
— Human Research Review Committee
DTDFA
— Division of Therapeutic Drugs for Food Animals
BBR
— Bureau of Biologics and Radiopharmaceuticals
AMA-DE
— American Medical Association Drug Evaluation
SGEMT (CFSAN)
— Special Government Employees Management Team (CFSAN)
ADI
— Acceptable Daily Intake (National Academy of Science)
SSB (CDRH)
— Systems Support Branch (CDRH)
ERIC
— Employee Resource Information Center
JAN
— Japanese Adopted Names
LD50
— Lethal Dose where 50% of the population dies
DCP (CFSAN)
— Division of Cooperative Programs (CFSAN)
DID (CBER)
— Division of Information Development (CBER)
ATO
— Authorization to Operate
SE
— Standard Error
ADP
— Associate Director for Policy
SCC
— Sector Coordinating Council for Food and Agriculture
IQMP
— Integrated Quality Management Plan
MRE
— Meal, Ready-To-Eat
DDRE (CDER)
— Division of Drug Risk Evaluation (CDER)
GRNS
— Generally Recognized as Safe Notifications
SHIE
— State Health Information Exchange
RCT (CFSAN)
— Recall Team (CFSAN)
NOA
— Notice Of Availability
SNIP
— Syndicat National de l'Industrie Pharmaceutique
DFSR
— Division of Federal-State Relations (Office of Regulatory Affairs)
ORPSS
— Office of Regulations, Policy, and Social Sciences
NSRT (CFSAN)
— Nutrition Science Review Team (CFSAN)
DDA
— Division of Drug Analysis
LDPE
— Low Density Poly-Ethylene
EOP1
— End-Of-Phase 1
ECP
— Emergency Contraception Pill
BUF-DO
— BUFfalo, New York, District Office
CCC
— Compliance Coordinating Committee
CACTIS
— Center ADP/TC Computer Tracking and Inventory System
FACD
— Food Additives and Chemicals Division
COS
— cosmetic registration number (ORA AofC code)
RIMS
— Regulatory Information Management Staff
HCT/P
— human cellular and tissue-based products
CIRS
— Center Information Retrieval System
DME (NCTR)
— Division of Molecular Epidemiology (NCTR)
DMO (ORA)
— Division of Management Operations (ORA)
CPFP
— Cancer Prevention Fellowship Program (NCI)
CDISC
— Clinical Data Interchange Standards Committee
INRO
— Intramural NIAID Research Opportunities (National Institute of Allergy and Infectious Diseases)
RDTS
— Reproductive and Developmental Toxicology Subcommittee (CDER)
IDC
— Information and Data Committee
FEEA
— Federal Employee Assistance and Education Fund
WOC I
— Woodmont Office Complex I (North)
DVS (NCTR)
— Division of Veterinary Services (NCTR)
DEOD
— Dental, Ear, Nose, Throat, and Ophthalmic Devices Branch
DOE A (CDRH)
— Division of Enforcement A (CDRH)
DLPS
— Division of Labeling and Program Support
NCP
— Non-Conforming Product
HSOC
— Homeland Security Operations Center
LPRVD (CBER)
— Laboratory of Pediatric and Respiratory Viral Diseases (CBER)
IMTS
— Industry Meeting Tracking System
SAT (CFSAN)
— Statistical Applications Team (CFSAN)
ECT (CFSAN)
— Economics Team (CFSAN)
DDMS
— Division of Database Management and Services
SAB
— Science Advisory Board (USEPA)
AME
— Absorption Metabolism Excretion
BDLS
— Blood Donor Locator Service
PARS (CDER)
— Program Activities Review Staff (CDER)
CVMP
— Committee on Veterinary Medical Products
PKA
— Prekallikrein Activator
HLBT
— Heat Labile Bacterial Toxins
NCHGR
— National Center for Human Genome Research (NIH)
OEXA
— Office of External Affairs (OC)
HIDE
— High Impact Data Elements
STARS
— Submission Tracking and Reporting System
SMF
— Site Master File
ACTB
— Analytical Chemical Techniques Branch
MPAB
— Management Programs and Analysis Branch
AIRIO
— Agency Intramural Research Integrity Officer
ARTCA
— Antimicrobial Regulations Technical Correction Act of 1998
NDMA
— Nonprescription Drug Manufacturers Association (now CHPA)
LIB (CBER)
— Laboratory of Immunobiochemistry (CBER)
NIDPOE
— Notice of Initiation of Disqualification Proceeding and Opportunity to Explain
DLAM
— Division of Laboratory Animal Medicine
AI
— Additional Information (Letter)
PAM
— Pesticide Analytical Manual
TBSB
— Therapeutics and Blood Safety Branch
DPDFS
— Division of Plant and Dairy Food Safety
DB (CDRH)
— Division of Biology (CDRH)
LACF
— Low-Acid Canned Food
WEDA
— Workforce Equity and Diversity Action
SAN-DO
— San Francisco District Office
DCC (CFSAN)
— Division of Cosmetics and Compliance (CFSAN)
BUS
— BIMS (Biologic IND (Investigational New Drug) Management System) User Support Group
WEDI
— Workgroup for Electronic Data Interchange
NREVSS
— National Respiratory and Enteric Virus Surveillance System
DPRF
— Drug Product Reference File
TSSS (CDER)
— Technology Support Services Staff (CDER)
IFE
— Import for Export
AVA
— American Veal Association
OFS (OC)
— Office of Financial Services (OC)
WLF
— Washington Legal Foundation
SMT (CFSAN)
— Statistical Methodology Team (CFSAN)
RIC
— Resident in Charge
OP 2
— Operations Team 2
CCA
— Clinger-Cohen Act (formerly the Information Technology Management Reform Act)
LARM
— Licensing Action Recommendation Memorandum
DDOP
— Division of Drug Oncology Products (FDA)
STB (ORA)
— State Training Branch (ORA)
ADR (CBER)
— Associate Director for Research (CBER)
PAAB
— Pharmaceutical Advertising Advisory Board (Canada)
CIS
— Catastrophic Incident Supplement
VE
— vaccine efficacy
ORS (CFSAN)
— Office of Regulatory Science (CFSAN)
CSC
— Cigarette Smoke Concentrate
TSS
— Transfusion Safety Study
MIWG
— Mentoring Implementation Working Group
CCEHRP
— Committee to Coordinate Environmental Health and Related Programs (PHS)
ESB (ORA)
— Enterprise Systems Branch (ORA)
MSAB
— Manufacturing and Storage Adulteration Branch
EVA
— Entry Validation Application
PDMA
— Prescription Drug Marketing Act of 1988
OMB (NCTR)
— Operations and Maintenance Branch (NCTR)
DDM
— Division of Dockets Management
AIN
— food additive identification number (ORA AofC code)
BAER
— Brief Adverse Event Report
OPL (OC)
— Office of Planning (OC)
RCS (CFSAN)
— Regulations Coordination Staff (CFSAN)
HIBCC
— Health Industry Business Communication Council
CSA
— Controlled Substances Act
LHREA (CBER)
— Laboratory of Hepatitis and Related Emerging Agents (CBER)
CGCS
— computer-generated cover sheet
NCHM
— National Center for Health Marketing
DTDNFA
— Division of Therapeutic Drugs for Non-food Animals
DMS (CDER)
— Division of Management Services (CDER)
TWG
— Technical Working Groups
GAAP
— Greater Access to Affordable Pharmaceuticals Act of 2003
ADP (CBER)
— Associate Director for Policy (CBER)
GHS
— Globally Harmonised System of Classification and Labelling of Chemicals
FLC
— Federal Laboratory Consortium
BNF
— biotechnology notification file
TBT
— Technical Barriers to Trade
SOC
— System Organ Class
ARL
— Arkansas Regional Laboratory
LS (CDRH)
— Library Staff (CDRH)
AUA
— Agency for Healthcare Research and Quality
NIAMS
— National Institute of Arthritis and Musculoskeletal and Skin Diseases
FOIB (CDRH)
— Freedom of Information Branch (CDRH)
ACT
— Applied Clinical Trials
IEC
— Independent Ethics Committee
OP 3
— Operations Team 3
IGA
— Immunoglobin A
LUACRG
— Lung and Upper Aerodigestive Cancer Research Group
DMC
— Data Monitoring Committee
AOFC
— Affirmation of Compliance
GIPSA
— Grain Inspection, Packers & Stockyards Administration (USDA)
NCVHS
— National Committee on Vital and Health Statistics
BLT
— Blood Logging and Tracking System
SPOTS
— Special Products On-line Tracking System
DMO (CFSAN)
— Division of Management Operations (CFSAN)
NLN
— Nordiska LäkemedelsNämnden (Nordic Council on Medicines)
NCMHD
— National Center on Minority Health and Health Disparities (NIH)
WAG
— Widely Attended Gathering
VBPF
— vegetative bacteria, protozoa and viruses
BCAA
— branched-chain amino acids
SMS (CFSAN)
— Safety Management Staff (CFSAN)
ORWH
— Office Research into Women's Health (NIH)
RDE
— Remote Data Entry
MTOS
— Muirkirk Technical Operations Staff (Laurel, Maryland)
MHBG
— Mental Health Services Block Grant
MLTC
— Managed Long-Term Care
AIP
— APHIS (Animal and Plant Health Inspection Service) Integrated Planning
IFIP
— International Federation For Information Processing
SQA
— Society of Quality Assurance
JIFSAN (CFSAN)
— JIFSAN Liaison Staff (CFSAN)
TI
— Tolerable Intake
MHW
— Ministry of Health and Welfare (Japan)
CM
— Chemistry and Manufacturing
MMDB
— Microbial Methods Development Branch
CTM
— Clinical Trials Materials
MBES
— Medicaid Budget and Expenditure System
DAR
— Division of Animal Research
ABC
— America's Blood Centers
GARR
— Grants Application Review Request
QSR
— Quality System Representative
OMS (NCTR)
— Office of Management Services (NCTR)
DOT (CFSAN)
— Division of Toxicology (CFSAN)
RSVIGIV
— respiratory synctial virus immune globulin intravenous
OPS
— Office of Pharmaceutical Science
CS
— Clinically significant
OVRR
— Office of Vaccines Research and Review
NIPP
— National Infrastructure Protection Plan
CC
— Conference Call
CRWG
— Hurricane Katrina Comprehensive Review Working Group
STS
— Standards and Testing Staff
LPB (OC)
— Leasing and Policy Branch (OC)
LRB (CDER)
— Labeling Review Branch (CDER)
NOV
— Notice Of Violation letter
PELT
— Product Evaluation and Labeling Team
MATS
— Management Assignment Tracking System
DFFI
— Division of Foreign Field Investigations (ORA)
PTEI
— Pittsburgh Tissue Engineering Initiative
DB
— Double-Blind
FSA
— Farm Service Agency (USDA)
INN
— International Non-Proprietary Name
NFT
— Notification of Foreign Travel
NOH
— Notice Of Hearing
NMR
— nuclear magnetic resonance spectroscopy
SME
— Significant Medical Event
MDUFA
— Medical Device User Fee Amendments of 2007
RSS
— RDF (Resource Data Framework) Site Summary
DE (CFSAN)
— Division of Enforcement (CFSAN)
AMB
— Adminstrative Management Branch
CERG
— CBER Emergency Relocation Group
DXA
— Dual-energy X-ray Absorptiometry test
DADS
— Department of Aging and Developmental Services
ARIES
— Administrative Resources Information Exchange System
BWM
— Biologics Workload Management
MDUFSA
— Medical Device User Fee Stabilization Act of 2005
ITT
— Intent to Treat
NTEU
— National Treasury Employees Union
EPL
— Effective Patent Life
BPC
— Bureau of Policy and Coordination
SACS
— Scientific Advisors and Consultants Staff
EOC
— Emergency Operations Center (FDA)
CTEB
— Cosmetics TEchnology Branch
INA
— Investigational New Animal drug number
OCTGT
— Office of Cellular Tissue and Gene Therapies
MCA
— Medicines Control Agency (part of MHRA)
RR
— Relative Risk Estimates
NEXT
— Nationwide Evaluation of X-ray Trends (CDRH)
CRC
— Civil Rights Center (U.S. Department of Labor)
HSBT
— Heat Stable Bacterial Toxins
DCM (CBER)
— Division of Case Management (CBER)
EPRG
— European Pharmacovigilance Research Group
ITIC
— Information Technology Implementation Committee (CBER)
INDE
— Investigational New Drug Exemption
PSSB
— Program Support Services Branch
SRAS
— Secure Remote Access Service
DTS
— Distribution Tracking System
WTW
— Welfare-to-Work
MACS
— Manufacturers Assistance and Communications Staff
CHID
— Combined Health Information Database (NIH)
WO (NCTR)
— Washington Office (NCTR)
BOS-DO
— BOSton, Massachusetts, District Office
ROA
— Read Only Access
CTOB
— Cosmetics TOxicology Branch
EAC
— Expert Advisory Committee (Canada)
OIA
— Office of Internal Affairs
BFAC
— Biologics Field Advisory Committee (CBER)
PTFE
— Polytetrafluroethylene
DH (CBER)
— Division of Hematology (CBER)
DQ
— Design Quality
SPS (CFSAN)
— Science and Policy Staff (CFSAN)
REIS
— Regional Economic Information System
ADAM7
— Analysis Data Model
OJDB (CDRH)
— Orthopedic Joint Devices Branch (CDRH)
NAF
— Notice of Adverse Findings
COBTA
— Council On Biologics and Therapeutic Agents
CC
— Commissioned Corps
IB (ORA)
— International Branch (ORA)
DPS (CBER)
— Division of Program Services (CBER)
NCRM
— National Comorbidity Survey Replication
DLS
— Diagnostic Laboratory Services
PLR
— Physician Labeling Rule
DRPM
— Dispute Resolution Project Manager
FIREBIRD
— Federal Investigator REegistry for BioInformatics Research Data
CO
— Contract Officer
BSD
— Blood Service Directive
TA
— Travel Authorization
SCAW
— Scientists Center for Animal Welfare
DDSL
— Division Data Standards Leads
BPD
— Biological Product Deviation
NEPA
— National Environmental Policy Act
DRS
— Drug-Resistance Survey
FAIR
— Federal Activities Inventory Reform Act of 1998
DSPB
— Data Standards Program Board
SIA
— Strip Immunoblot Assay
MCMI
— Medical Countermeasures Initiative
ERSR
— Electronic Regulatory Submissions and Review
NRSP
— National Research Support Project
REGO
— Reinventing the United States Government
CODB
— Cardiovascular and Ophthalmic Devices Branch
LOINC
— Logical Observation Identifier Name Code
DI
— De-Ionized
BENS
— Business Executives For National Security
OIVD
— Office of In-Vitro Diagnostic Device Evaluation and Safety
DNT (NCTR)
— Division of Neurotoxicology (NCTR)
MDL
— MoDeL number
SSC
— Systems Steering Committee
MEMO
— Medicines Evaluation and Monitoring Organization
NDCR
— New Drug Comparison Rating
OCTEC
— Office of Counter-Terrorism and Emergency Coordination
NVOAD
— National Volunteer Organizations Active in Disaster
CTS
— counseling and testing site
BRCC
— Biologics Research Coordinating Committee
MATTB
— Manufacturers Assistance and Technical Training Branch
SWDB (CDRH)
— Software and Web Development Staff (CDRH)
DID
— Department of Infectious Diseases
RIHSC
— Research Involving Human Subjects Committee (FDA)
NED
— NIH (National Institutes of Health) Enterprise Directory
CALA
— computer-assisted license application
NVCJD
— New Variant Creutzfeldt-Jakob Disease
SITP(OC)
— Strategic IT Programs (OC)
ART
— Assisted Reproductive Therapy
EAB
— Ethics Advisory Board
GOCRG
— Gastrointestinal and Other Cancer Research Group
DMA
— Danish Medicines Agency
LRP
— Low Regulatory Priority
MFA
— Medicated Feed Application number
NDTI
— National Disease and Therapeutic Index
NEFARMA
— NEederlandse FARMAceutische Industrie (NEtherland Association of the Research-oriented PHARMAceutical Industry)
IDF
— Immune Deficiency Foundation
AMF
— Administrative Management of Files
USTFA
— U.S. Trout Farmers Association
FAHCT
— Foundation for Accreditation of Hematopoietic Cell Therapy
NISAC
— National Infrastructure Simulation and Analysis Center (Department of Homeland Security)
GCRC
— General Clinical Research Centers
PST
— Porcine Somatotropin
IRPB
— International Research and Programs Branch
HIRS
— Health Information Resources Service
UMCP
— University of Maryland-College Park
PAT
— Process Analytical Technology Initiative
NDAC
— Nonprescription Drug Advisory Committee
SPS
— Sanitary and PhytoSanitary
LASIK
— Laser ASisted In-situ Keratomileusis
LSHLC
— Lipid-Soluble Heat-Labile Chemical
LCP
— Laboratory of Clinical Pharmacology
USPEA
— US Poultry & Egg Association
ODE (CDRH)
— Office of Device Evaluation (CDRH)
TRANS NET
— internet-based blood shortage reporting program (FDA)
DRFDD
— Deputy Regional Food and Drug Director
FHSA
— Federal Hazardous Substances Act (Consumer Product Safety Commission)
PB (CDRH)
— Planning Branch (CDRH)
DSAC
— Division of Scientific Advisors and Consultants
BT
— Bioterrorism
LRIS
— Lot Release Imaging System
QMS
— Quality Management Staffing
MDDRP
— Medical Device Dispute Resolution Panel
FIFR
— first-in-first reviewed
RAM
— Reporting and Analysis Module
SIR
— Society of Interventional Radiology (formerly SCVIR)
CPMS
— Chief, Project Management Staff (CDER)
UNII
— Unique Ingredient Identifier
MDUFMA
— Medical Device User Fee and Modernization Act of 2002
CSAP
— Center for Substance Abuse Prevention (SAMHSA)
SSCT
— Swedish Society for Clinical Trials
ELIST
— electronic listing system
SACD
— Special Assistant to the Center Director
CPAC
— Central Pharmaceutical Affairs Council (Japan)
FCE
— Food Canning Establishment number
SSM
— Skin Surface Microscopy
HAA
— Hepatitis-Associated Antigen
SGE
— special Government employee
IFWG
— Interagency Food Working Group
MVB
— Molecular Virology Branch
DM (CFSAN)
— Division of Mathematics (CFSAN)
INS
— Incident of National Significance
LCT
— Labeling Compliance Team
SFLEO
— Senior Federal Law Enforcement Official
DB (CBER)
— Division of Biostatistics (CBER)
DEHP
— Di(2-ethylhexyl)phthalate
CARES
— Cardiac Arrest Registry to Enhance Survival [CDC]
DBC (CFSAN)
— Division of Bioanalytical Chemistry (CFSAN)
SBIR
— Small Business Initiated Research
PTC
— Points to Consider
VATS
— Vacancy Announcement Tracking System
HSS
— hemophilia surveillance system
DCM
— Division of Case Management
CSDD
— Center for the Study of Drug Development (Tufts University)
OR
— Office of Research
BER
— Blood Establishment Registration and Product Listing
PQAS
— Pharmaceutical Quality Assessment System
DEN
— Drug Experience Network
REDS-II
— Retrovirus Epidemiology Donor Study Two
ESG
— Electronic Submissions Gateway
CA
— Committee Assignment
NHIS
— National Institute of Hygienic Sciences
MOD
— Miscellaneous Obligation Document
NPG
— National Preparedness Goal
MCM
— Medical Countermeasures
FPBR
— Food Packaging Branch (Chicago, Illinois)
PER
— Pharmaceutical Evaluation Report
HSUS
— Humane Society of the United States
FAME
— Formula for Achieving Managerial Excellence
ACT
— AIDS Clinical Trials
MIG
— Medicaid Infrastructure Grant
NAET
— Nutrition Assessment and Evaluation Team
HDP
— Hydroxymethylene Di-Phosphonate
OSS
— Office of Shared Services
COPR
— Council of Public Representatives (NIH OD)
OE (ORA)
— Office of Enforcement (ORA)
RDB
— Radiological Devices Branch
DD
— Department of Drugs (Swedish regulatory agency)
LCI
— Livestock Conservation Institute
NWR
— NOAA (National Oceanic and Atmospheric Administration) Weather Radio
DDSPC
— Division of Dietary Supplement Programs and Compliance
BPSRG
— Biomedical and Pharmaceutical Sciences Research Group
SLIP
— serial line internet protocol/point-to-point protocol
USPC
— United States Pharmacopeial Convention
RIS
— Regulatory Information Specialist
RTAU
— Review and Technical Assistance Unit
PAMP
— Post-approval Monitoring System
PVDB
— Peripheral Vascular Devices Branch
FU
— Farmacopea Ufficiale (Italian Pharmacopoeia)
DBS (CDRH)
— Division of Biostatistics (CDRH)
LBL
— Ernest Orlando Lawrence Berkeley National Laboratory
NSABPB
— National Surgical Adjuvant Breast and Bowel Project
ULDB
— Urology and Lithotripsy Devices Branch
ARCH
— Administrative Resources Core Hub
ABM
— Application Briefing Meeting
NON
— Notice Of Non-Compliance
RICHS
— Rural Information Center Health Service
FMS
— Financial Management Service (U.S. Department of the Treasury)
AL
— Approvable Letter
BOCB
— Biological and Organic Chemistry Branch
BSB
— Biotechnology Studies Branch (Chicago, Illinois)
ADR
— Associate Director for Research
OC
— Immediate Office of the Commissioner
[NA]TAG
— [North American] Technical Advisory Group
ONDCP
— Office Of National Drug Control Policy
PTE
— Patent Term Extension
TSOP
— Temperature Standard Operating Procedure
DM (CFSAN)
— Division of Microbiology (CFSAN)
UMLS
— Unified Medical Language System (NLM)
DPP
— Division of Psychiatry Products
FAQD
— Frequently Asked Questions Database
BRAIN
— Brain Research through Advancing Innovative Neurotechnologies
SLK
— Statens Legemiddel Kontroll (Norwegian Medicines Control Authorities)
VS (CBER)
— Validation Staff (CBER)
OJDB
— Orthopedic Joint Devices Branch
BCB
— Bioanalytical Chemistry Branch
CUF
— Commissione Unica del Farmaco (Italy)
URAA
— Uruguay Round Agreements Act of 1994
FEHB
— Federal Employees Health Benefits
BTCB
— Blood and Tissue Compliance Branch
LARD
— Licensing Action Recommendation Document
MRFG
— Mutual Recognition Facilitating Group
SCVIR
— Society for Cardiovascular and Interventional Radiologists (now SIR)
PAIS
— Public Affairs and Information Staff
DDE
— Dymanic Data Exchange
OMRF
— Oklahoma Medical Research Foundation
MIP
— Management Improvement Plan
OSE
— Office of Surveillance and Epidemiology
NDE
— New Drug Evaluation
RCS
— Records Control Schedule
WEAC
— Winchester Engineering & Analytical Center
JFHQ
— Joint Force Headquarters
WEBSDM
— Web-based Submission Data Manager
EIEIO
— External Interference Engineering Investigations Office
DPA
— Division of Pharmaceutical Analysis
SEND
— Standards for Exchange of Nonclinical Data
IAG
— Inter-Agency Agreement
SAI
— Single Active Ingredient
IPU
— Irish Pharmaceutical Union
LSHSC
— Lipid-Soluble Heat-Stable Chemical
MGSS
— Multi-Generation Support System
DSRIT
— Dietary Supplement Regulations Implementation Team
PTB
— Pharmacology and Toxicology Branch
OEI
— Official Establishment Inventory
VMD
— Veterinariae Medicinae Doctoris
OSCAR
— ORACLE System for Center Automation and Retrieval
CH
— Clinical Hold
RUP
— Restricted Use Pesticide
JFTR
— Joint Federal Travel Regulations
DDB
— Dental Devices Branch
CCI
— Corrected Count Increment
EGA
— European Generics Medicines Association
DSB
— Drug Safety Oversight Board
COE
— Certificate of Exportability
ORPS
— Office of Real Property Services
ESM
— Electronic Secure Messaging
DPCPSI
— Division of Program Coordination, Planning, and Strategic Initiatives
AWC
— Adequate and well-controlled
RRS16A0S
— Regulatory Review Support Staff
DVH
— Division of Viral Hepatitis (CDC)
IVMD
— In-Vitro Medical Device
CID
— Center for Infectious Diseases
FPET
— Food Processing Evaluation Team
RSVIG
— respiratory synctial virus immune globulin
DIMS
— Data Information Management Staff
RCH
— Remove Clinical Hold
VIG
— Vaccinia Immune Globulin
SAP
— Scientific Advisory Panel (SARCS)
MT
— Medical Team
RKW1
— Rockwall Building I
NLM
— National Library of Medicine (NIH)
GCBS
— Global Collaboration for Blood Safety (WHO)
TSOPS
— temperature standard operating procedures
GEO
— Genetically Engineered Organism
DPAP
— Division of Pulmonary and Allergy Products
TSSRC
— Toxicology Study Selection and Review Committee
VMF
— Veterinary Master File
EER
— Establishment Evaluation Request
RFCPCS
— Retail Food and Cooperative Programs Coordination Staff
RTL
— Reproductive Toxicology Laboratory
MHSB
— Microbial Hazards Science Branch
CAP
— Control of Automated Processes
IVD
— In-Vitro Diagnostics
CDR
— Cognitive Drug Research
PV
— Process Validation
WIC
— Women, Infants, and Children nutrition program
ILAR
— Institute For Laboratory Animal Research
CRR
— Consult Review Request
REG
— Drug REGistration number
TBLS
— Team Biologics Liaison Staff (CBER)
ISE
— Integrated Summary of Efficiency
WIGI
— WithIn-Grade Increase
DS
— Drug Substance
WSHSC
— water soluble, heat stable chemicals
STAI
— STrait Anxiety Inventory
MRRA
— Microbial Research and Risk Assessment Staff
BLST
— Building and Laboratory Services Team
SPLAT
— Structured Product Labeling Advisory Team
CPC
— Compliance Policy Council
BDS
— Bureau of Drug Surveillance (Canada)
PSS (CDRH)
— Patient Safety Staff (CDRH)
OAT
— Office for the Advancement of Telehealth
CU
— Consumer's Union
AGD
— action goal date
SPLIEP
— Structured Product Labeling Interagency Executive Panel
NSV-DO
— Nashville, Tennessee, District Office
IMC
— Information Management Consultants, Inc.
SCRRB
— Scientific Compliance and Regulatory Review Branch
NCIMS
— National Conference on Interstate Milk Shipments
NA
— Not Approvable
IMDA
— Irish Medical Device Association
HPUS
— Homeopathic Pharmacopeia of the United States
FPB
— Food Processing Branch (Chicago, Illinois)
ISA
— Information Systems Architecture
UMS
— Unified Modeling Language (Object Management Group)
SSAST (CFSAN)
— Senior Science Advisor's Staff (CFSAN)
DC
— Discharge Curve
TOL
— total organic carbon
DDR
— Donor Deferral Registry
HEO
— Hispanic Employee Organization
CTA
— Clinical Trial Application
OCPP
— Office of Critical Path Programs
LHV
— Laboratory of Hepatitis Viruses
RTA
— Refusal To Accept
SCGD
— Special Controls Guidance Document
TOPOFF
— Top Officials
VCPR
— Veterinarian Client/Patient Relationship
PMPRB
— Patented Medicine Prices Review Board
LCH
— Laboratory of Cellular Hematology
CST
— Consumer Safety Technician
OD (NCTR)
— Office of the Director (NCTR)
SITP
— Strategic Information Technology Program
SMPS
— Standards Management Program Staff
LS
— Labelling Standard
STCD
— sterile connecting device
NAT
— Nucleic Acid-based Tests
DA
— Division of Accounting
NVSN
— New Vaccine Surveillance Network
CMT
— Cosmetics Toxicology Branch
MON
— Memorandum of Need
DPR
— Division of Petition Review
M204
— Model 204 DataBase Management System
EFGCP
— European Forum on Good Clinical Practice
RIF
— reduction-in-force
RRS0S
— Regulatory Review Support Staff
NIMH
— National Institute of Mental Health (NIH)
NKCA
— Natural Killer cell Cytotoxic Activity
OSMP
— Office of Special Medical Programs
OPMAD
— Orthopedic Physical Medicine and Anesthesiology Devices Branch
CTC
— Clinical Trial Certificate (U.K.)
DSS (CDRH)
— Division of Surveillance Systems (CDRH)
NSIP
— National Seafood Inspection Program
VSOF
— Visual Status of Funds
RCC
— Research Coordinating Committee
TB
— Tuberculosis Bacillus
SIS
— Streamlined Inspection System
COOL
— country-of-origin labeling
EPRS
— Establishment Product Registration System
ULPA
— Ultra-Low Penetration Air
FR.P.
— Pharmacopee Francaise (French Pharmacopoeia)
ISS
— Integrated Summary of Safety
RMS
— Reference Member State
EPI
— ESSENTIAL PRESCRIBING INFORMATION
PT
— Preferred Term
NRP
— National Response Plan (Department of Homeland Security)
DDSLWG
— Division Data Standards Leads Working Group
CAST
— Calf Antibiotic and Sulfonamide Test
PSP
— Physician Special Pay
SAF
— state access to FACTS
ECBS
— Expert Committee on Biological Standardization (WHO)
MRTP
— Modified Risk Tobacco Products
PAL
— Public Affairs Liaison
NSWL
— Naval Surface Weapons Laboratory (now FDA White Oak campus)
ICCR
— International Cooperation on Cosmetics Regulation
PAD
— Pharmacologically Active Drug
RES
— Recall Enterprise System (ORA)
CND
— Cardiovascular/Neurological Devices Branch
EIF
— Expected Investment Fund
STA
— Special Temporary Authority
SLO
— State Liaison Officer
IRA
— Immediate Response Authority
DC
— Discharge Clinic
ORAC
— Oxygen-Radical Absorbance Capacity
ODS
— Office of Dietary Supplements
APAC
— Allergenic Products Advisory Committee
IA
— Import Administration (United States Department of Commerce)
RPM
— Regulatory Project Manager
SE
— SUBSTANTIALLY EQUIVALENT
DEPI
— Division of EPIpidemiology
VICH
— Veterinary International Committee on Harmonisation
ODSIR
— Office of Drug Security Integrity and Recalls
RVIS
— Residue Violation Information System
EDKB
— Endocrine Disrupter Knowledge Base
CRS
— Contamination Response System
ISR
— Individual safety report
USUHS
— Uniformed Services University of the Health Sciences
DRI
— Daily Reference Intake
VCTB
— Vaccine Clinical Trials Branch
TSEAC
— Transmissible Spongiform Encephalopathies Advisory Committee (CBER)
MGB
— Molecular Genetics Branch
PDLB
— Pacing, Defibrillator, and Leads Branch
GRS
— General Records Schedule
OOP
— Order Of Predominance (in the ingredients statement)
ETA
— EASE (Enterprise Administrative Support Environment) Time and Attendance module
ICAM
— International Cooperative Agreements Manual
CSC
— Centre for Surveillance Coordination
OFFAS
— Office of Field Financial and Acquisitions Services
ICL
— idiopathic CD4 T-lymphocytopenia
LIR
— Laboratory of Immunoregulation
FRP
— Federal Response Plan (FEMA)
BSTS
— Bundled Supplement Tracking System
NLRC
— Nicholson Lane Research Center
AR
— approvable letter
RES (OC)
— Regulations Editorial Section (OC)
PIV
— Personal Identify Verification
TEB
— Therapeutics Evaluation Branch
OTFP
— Other Than a Food Processing facility
MPN
— Metro Park North
NAM
— National Agency for Medicines
VSPB
— Viral Special Pathogens Branch (CDC)
RAMB
— Research Animal Medicine Branch
SSP
— Sector-Specific Plan
DCIS
— Design Control Inspection Strategy
MFR
— ManuFactureR
ITS
— Information Technology Staff
BASIS
— Blood Availability and Safety Inventory System
CORE
— Central REpository module
USMS
— United States Marshals Service's
SNS
— strategic national stockpile (CDC)
PFL
— Professional Flexible Labeling
IGD
— Immunoglobin D
FTR
— Federal Travel Regulations
RCR
— Risk Control Review
CRM
— corporate records management
OPL
— Office of PLanning
OR (CVM)
— Office of Research (CVM)
SE
— Safe and Effective
RPS
— Regulatory Policy Staff
DIB
— Director, Investigations Branch
TRU
— Temporary Recommendations for Use
UDHQ
— Uniform Donor Health Questionnaire
ISIS
— import support and information system
HDE
— Humanitarian Use Exemption
SEB
— Subsequent Entry Biologic
AIS
— Abbreviated Inspection System
SDSRCCG
— Study Data Standards Resources Change Control Group
NVTB
— Neurotoxicological and in-Vitro Toxicology Branch
BARC
— Beltsville Area Agricultural Research Service
DEP
— Data Evaluation Project
VHSP
— Viral Hepatitis Surveillance Program (CDC)
OSP
— Office of Suicide Prevention
DSSC
— Dietary Supplements Subcommittee
NPSB
— Nutritional Product Studies Branch
ELPS
— establishment licensing and product surveillance
ITCC
— Information Technology Coordinating Committee
TVBB
— Tumor Vaccines and Biotechnology Branch
RTR
— Recall Termination Recommendation
GT
— Gutta (drops)
CABS
— Conformity Assessment Bodies
PTR
— Platelet Transfusion Reaction
IAL
— Informal Action Level
PB
— Planning Branch
SSA
— Sector-Specific Agencies
FPL
— Final Printed Labeling
TRIMS
— Tissue Residue Information Management System
SVP
— small-volume parenteral
ESC
— Electronic Submission Coodinator
RTE
— Ready-To-Eat
BPA
— Bureau of Pharmaceutical Assessment
CDR
— Clinical Drug Request
ETR
— Electronic National Tuberculosis Registry
TMO
— Trial Management Organization
IOB
— International Operations Branch (ORA)
SG
— Study Group
OMP
— Office of Management Programs
VCOOL
— Voluntary Country-Of-Origin Labeling
RFPT
— Retail Food Protection Team
TEP
— therapeutic exchange plasmapheresis
NCRR
— National Center for Research Resources (NIH)
PPV
— Patient Profile Viewer
SOM
— Sensitivity of Method
LVP
— Large-Volume Parenteral
IBP
— Indian Black Pepper certificate
TPI
— Tan Protection Index
ESB
— Enterprise Systems Branch
CTO
— Clinical Trial Outline
BCA
— Blood Center of America
OAP
— Office of Antimicrobial Products
IHSP
— influenza Hospitalization Surveillance Project
FACS
— Food Advisory Committee Staff
RL
— regulatory letter (FDA post-audit letter)
MAV
— maximum allowable variation
CLA
— conference lodging allowance
NHE
— National Health Expenditures
SIP
— Survey of Institutionalized Persons
WCHI
— Workers Compensation Health Initiative
MRD
— Multiple Rising Dose
DFS
— Division File System
TAV
— travel authorizations and vouchers
TESS
— Toxic Exposure Surveillance System
VETTRADE
— Veterinarian Trading Post (website)
IGM
— VCA)-immunoglobin M
SCT
— Society for Clinical Trials
NDI
— National Death Index (CDC)
TELECON
— TELEphone CONferencing
SMART
— Submission Management and Review Tracking
HCBW
— Home and Community-Based Waiver
RPM
— Regulatory Procedures Manual (ORA)
NIP
— National Immunization Program (CDC)
PTK
— PhotoTerapeutic Keratectomy
GGP
— Good Guidance Practice
CAP
— Color Additive Petition
FIRST
— FDA Information Retrieval System
SAER
— Standard Adverse Event Report Review (CDRH)
RKW2
— Rockwall Building II
TLV
— Threshhold Limit Value
MMSB
— Molecular Methods and Subtyping Branch
SSC
— Special search category
SFB
— Spore-Forming Bacteria
CDIS
— Component Distribution Information System
SCSB
— Scientific Computer Support Branch
VS
— Visiting Scientist
USHIK
— United States Health Information Knowledge Base
TEDS
— Treatment Episode Data Set
ATS
— Applied Technologies Staff
STOP
— Safe Tables Our Priority
LAR
— Licensing Action Recommendation
IDHL
— Inherently Dangerous to Human Life
IPC
— In-Process Control
FF
— Fogarty Fellow
TPD
— TheTherapeutic Products Directorate
RMS
— Review Management Staff
DEV
— DEVice Registration Number
RD
— Registration Dossier
DADS
— Developers and Distributors System
IPM
— Import Program Manager
NOSB
— National Organic Standards Board
AS
— Administrative Staff
MVT
— Molecular Virology Team
DC
— Discharge Capacity
TDS
— TOTAL DIET STUDY
SCL
— Symptom CheckList
UN
— unacceptable
IIC
— Inspector-In-Charge
CMG
— Cetyl Myristoleate, MSM, Glucosamine
SUD
— Single-Use Device
SDM
— Submission Data Model
RSS
— Regulatory Support Staff
RIM
— reference information model (HL7)
ERSB
— Emergency Response and Surveillance Branch
NDIRS
— New Dietary Ingredients Review Staff
DPPS
— Division of Plant Product Safety
MARS
— Mobile Automated Regulatory Services (ORA)
RIT
— RELOCATION INCOME TAX
HCP
— HealthCare Provider
CRU
— Center Recall Unit
MASC
— Manipulated Autologous Structural Cell
TAH
— Transfusion-Associated Hepatitis
BMB
— Bioanalytical Methods Branch
GSP
— Good Statistics Practice
NCC
— National Coordinating Committee
OEP
— Office of Emergency Preparedness (PHS)
SDTM
— Study Data Tabulation Model
FML
— Firms Master List
UFC
— Unacceptable to Foreign Country
OD (CBER)
— Office of the Director (CBER)
DSC
— Drug Safety Communication
DC
— Discharge in Cylindrical
SRD
— Single Rising Dose
IRIS
— International Regulatory Issues Staff
PDI
— Post-Donation Information
OST
— Office Services Team
AT
— Acquisitions Team
WNME
— West Nile MeningoEncephalitis
NGB
— National Guard Bureal
FIT
— FDA Internet Improvement Team
EA
— Environmental Assistance
PTS
— Product Testing Section
SPRC
— Seafood Products Research Center
OBI
— Office of Business Informatics
SDOS
— Study Data Operations Subcommittee
HPK
— Human PharmacoKinetic
SR
— Significant Risk
FAI
— Further Action Indicated
GAT
— genome amplification testing
SA
— Sustained Action
SDN
— Screening Deficiency Notice
AD
— Action Due
MDP
— Medical Devices Program
RFR
— Reportable Food Registry
OSCI
— Office of SCIence
SM
— Starting material
MID
— Manufacturer IDentifier
TAA
— transfusion-associated AIDS
LI
— Learned Intermediary
TA
— Technology Administration
SEDS
— Shared Establishment Data Service
ODA
— Orphan Drug Act of 1983
OPI
— Office of Planning and Informatics
MAT
— Modular Antigen Transporter
NIM
— No Inspection Made
RCS
— Regulations Coordination Staff
LBP
— Laboratory of Bacterial Polysaccharides
SSCA
— Statistics, Surveillance, and Control Archive (CDC)
SMG
— Staff Manual Guide
CR
— COLLECTION REPORT
PARS
— Program Activities Review Staff
NC
— Non-Clinical
OIM
— Office of Information Management
RSB
— Recalls and Shortages Branch (CDER)
GPP
— good programming practices
DRA
— Division of Risk Assessment
NGC
— National Guideline Clearinghouse (DHHS)
PAMS
— Post-Approval Monitoring System
SLR
— Supplement Labeling Revision
WPC
— WordPerfect Character (mapping file)
OPT
— Office of Pediatric Therapeutics
ERR
— Entry Review Recommended
EASE
— Enterprise Administrative Support Environment
WIB
— Western ImmunoBlot
SPL
— Structured Product Labeling
FSTA
— federal supervisory travel approver
IDM
— Informational Disclosure Manual
RIS
— Retroviral Immunology Section
SRMS
— Specified Risk Materials
SIG
— strategic implementation group
WO
— White Oak Campus
SIMCEN
— National Exercise Simulation Center
RDT
— rising dose tolerance
SOPA
— Submission of Portion of Application
SDSC
— Study Data Standards Catalog
CP
— Citizen Petition
BIP
— Balancing Incentive Program
PDA
— Prescription Drug Advertising
SRS
— Substance Registration System
PSS
— Patient Safety Staff
SPPA
— Strategic Partnership Program Agroterrorism initiative
SDS
— Submission Data Standards
TB
— Tuberculosis Background
SPS
— Science and Policy Staff
PSN
— Patient Safety News (FDA)
RFD
— Request for Designation
SRD
— Significant Risk Device
ML
— Manufacturer's License
RPS
— Regulated Product Submissions
SS
— Serving Size
TB
— Tuberculosis Basic
SE
— Salmonella Enteriditis
FIH
— First-In-Human
TPH
— Tropical Public Health
FRAC
— FDA Research Animal Council
SIF
— Seafood HACCP Importer Form
CSC
— Computational Science Center
VPS
— Veterinary Product Safety
GG
— Goal Group
SDSD
— Study Data Specifications Document
SMT
— Statistical Methodology Team
DLR
— Drug Listing Rule
RSVP
— Resource reporting System Via Projects
MJ
— Major Amendment
SD
— Scientific Director
BTA
— BioTerroism Act of 2002
MWG
— Milk Working Group
DC
— Discharge Conduit
RCT
— ReCall Team
FA
— Filing Action
UA
— UrinAnalysis
FII
— FarmIndustria Italy
DMB
— Dockets Management Branch
RP
— Resident Post
NTB
— NeuroToxicology Branch
SGI
— Summer Genetics Institute
IEE
— Intervention Effect Estimate
PAGE
— PolyAcrylimide Gel Electrophoresis
RTM
— Recall Team Member
ITF
— Inspection Task Force (CBER)
TK
— Toxicokinetics
TO
— table of oganization
RR
— Recall Recommendation
NVC
— National Vaccine Commission
RIPA
— radioimunoprecipitation assay
WSL
— Washington Seafood Laboratory
TA
— Temporary Abeyance
DDS
— Deputy Director for Safety (CDER)
RH
— responsible head
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