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>> Fda Abbreviations
Look through 3648 acronyms and abbreviations related to Fda:
CPR
— Cardiopulmonary Resuscitation
LAN
— Local Area Network
PRIM & R
— Public Responsibility in Medicine and Research
CF
— Cystic Fibrosis
N/A
— Not Applicable
L & D
— labor and delivery
PR (CBER)
— Product Review Branch (CBER)
PREA
— Pediatric Research Equity Act of 2003
PRB (CFSAN)
— Pathology Branch (CFSAN)
PRB (CBER)
— Product Release Branch (CBER)
ASAP
— As Soon As Possible (pronounced AY-sap)
COPD
— Chronic Obstructive Pulmonary Disease
PPWMB (ORA)
— Program Planning and Workforce Management Branch (ORA)
PQLS (CBER)
— Product Quality Laboratory Staff (CBER)
PPS (CBER)
— Policy and Publications Staff (CBER)
YTD
— Year To Date
S & E
— safety and effectiveness
PRA
— Paperwork Reduction Act of 1995
POS (CDRH)
— Program Operations Staff (CDRH)
I & D
— incision and drainage
POS (CBER)
— Program Operation Staff (CBER)
PO
— Per Os (by mouth)
PPB (CFSAN)
— Plant Products Branch (CFSAN)
ANSI
— American National Standards Institute, Inc.
POB (CBER)
— Program Operations Branch (CBER)
PPSR
— Proposal for Pediatric Studies Request
PPTA
— Plasma Protein Therapeutics Association
PQLS
— Product Quality Laboratory Staff
PPC
— Production and Process Controls
OEM
— Original Equipment Manufacturer (usually in reference to car parts)
PPWMB
— Program Planning and Workforce Management Branch
POWER
— Petition Optical Workflow, Exchange, and Retrieval
PPS
— Policy and Publications Staff
IMP
— Investigational Medicinal Product
DM
— Diabetes mellitus
XML
— Extensible Markup Language
CHF
— Congestive Heart Failure
R & E
— Recall and Emergency (ORA)
FTP
— File Transfer Protocol
IT
— Information Technology
Q1H
— Every 1 Hour
I & O
— intake and output
ECG
— Electrocardiogram
EPA
— Environmental Protection Agency (US)
CABG
— Coronary Artery Bypass Graft
RFID
— Radio Frequency Identification
Q & A
— questions and answers
LASER
— Light Amplification By Stimulated Emission Of Radiation (cf. Maser)
COB
— close of business (End of duty day)
AF
— Atrial Fibrillation
FLSA
— Fair Labor Standards Act
UK
— United Kingdom of Great Britain and Northern Ireland
PDF
— Portable Document Format (created by Adobe Acrobat)
FIFO
— First In, First Out
FAQ
— Frequently Asked Questions (sometimes Pronounced Fak)
R & W
— recreation and welfare
MOU
— Memorandum of Understanding (an MOU between Food & Drug Administratin and a regulatory agency in another country allows mutual recognition of inspections)
POC
— Point Of Contact
DAT
— Diet As Tolerated
PNS (CDRH)
— Premarket Notification Section (CDRH)
R&D
— Research & Development
GUI
— Graphical User Interface (goo-ey)
QC
— Quality Control
PMS (OC)
— Print Media Staff (OC)
ATM
— Automatic Teller Machine
M&IE
— Meals and Incidental Expenses
PNC (ORA)
— Prior Notice Center (ORA)
HIPAA
— Health Insurance Portability and Accountability Act of 1996
PMSB (CBER)
— Program Management Services Branch (Center for Biologics Evaluation and Research)
PMSB (CDER)
— Program Management Services Branch (Center for Drug Evaluation and Research)
TQM
— Total Quality Management
R & D
— research and development
CSR
— Customer Service Representative
MRI
— Magnetic Resonance Imaging
PMS (CDRH)
— Program Management Staff (CDRH)
CVA
— Cerebrovascular Accident
PNS
— Premarket Notification Section
BPM
— Beats Per Minute
EDI
— Electronic Data Interchange
RFP
— Request For Proposal
ISP
— Internet Service Provider
UNESCO
— United Nations Educational, Scientific and Cultural Organization
PMSC
— Pre-Market Surveillance and Compliance
CY
— Calendar Year
PIC/S
— Pharmaceutical Inspection Co-operation Scheme
TBD
— To Be Determined
PMSB
— Pharmaceutical and Medical Safety Bureau (Japan)
CBC
— Complete Blood Count
VPN
— Virtual Private Network (ATM)
FEMA
— Federal Emergency Management Agency
SSN
— Social Security Number
UNICEF
— United Nations International Children's Emergency Fund
PGB (CFSAN)
— Policy Guidance Branch (CFSAN)
ANOVA
— Analysis of Variance (statistics)
PETG
— Polyethylene Terephthalate Glycol
OTC
— Over The Counter (medications not requiring a prescription)
CPP
— Certificate of Pharmaceutical Product
MRB
— Material Review Board
CT
— Computed Tomography
PIB (CBER)
— Program Inspection Branch (CBER)
CEO
— Chief Executive Officer
PMHS (CDER)
— Pediatric and Maternal Health Staff (CDER)
ASME
— American Society of Mechanical Engineers
OCC (OC)
— Office of the Chief Counsel (OC)
SME
— Subject Matter Expert
PGB
— Policy Guidance Branch
P & PC
— production and process controls
WWW
— World Wide Web
QA
— Center for Quality Assurance in International Education
DOD
— United States Department of Defense
IV
— Intravenous
PNIG
— Patient Narrative Information Guide
ASTM
— American Society for Testing and Materials (Philadelphia, Pennsylvania)
BA/BE
— Bio-Availability/Bio-Equivalence
PLI
— Pre-License Inspection
PMN#
— Pre-Market Notification number of a device
FY
— Fiscal Year
PMC
— Post-Marketing Commitment
HTTP
— Hypertext Transfer Protocol
ADP
— Automated Data Processing
ACTH
— Adrenocorticotropic Hormone
WAN
— Wide Area Network
ADH
— Antidiuretic Hormone
FYI
— For Your Information
PMA#
— Pre-Market Approval device number
RSV
— Respiratory Syncytial Virus
SD
— Standard Deviation
PHSA
— Public Health Service Act of 1944
PLF
— Product Licensing Framework (Canada)
EEO
— Equal Employment Opportunity
MSDS
— Material Safety Data Sheets
WBS
— Work Breakdown Structure
PIP
— Plant-Incorporated Protectant
SMTP
— Simple Mail Transfer Protocol
ARPA
— Advanced Research Projects Agency (made early internet)
GI
— Gastrointestinal
SOW
— Statement Of Work
PIB
— Program Inspection Branch
CNS
— Central Nervous System
PMCC
— Project Management Coordinating Committee
FX
— Fracture
RAM
— random-access memory
IPO
— Initial Public Offering
PMHS
— Pediatric and Maternal Health Staff
USDA
— United States Department of Agriculture
KG
— Kilogram
PHN
— Population, Health, and Nutrition Center
CPI
— Consumer Price Index
E-CRF
— electronic case report form
BP
— Blood Pressure
PLAS
— Prior Label Approval System
PC
— Personal computer (host)
A-VO2
— arteriovenous oxygen
AMA
— American Medical Association
AARP
— American Association of Retired Persons
DBA
— Doing Business As
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.
BBS
— Bulletin Board System
XDR-TB
— Extensively Drug-Resistant Tuberculosis
CBO
— Congressional Budget Office
CV
— Curriculum Vitae
PKLN
— ParkLawn Building
CFR
— Code of Federal Regulations
DIC
— disseminated intravascular coagulation
DAARP (CDER)
— Division of Anesthesia, Analgesia, and Rheumatology Products (CDER)
B&F (CVM)
— Budget and Finance Team (CVM)
DX
— Diagnosis
PIFSI
— Produce and Imported Foods Safety Initiative
CVP
— Central Venous Pressure
SQL
— Structured Query Language
ISDN
— Integrated Services Digital Network
PSUR
— Periodic Safety Update Report
DHCP
— Dynamic Host Configuration Protocol
DSS
— Decision Support System
G-MED (LNE)
— Groupfor Medical Device Assessment (Laboratoire National de Metrologie et d'Essias)
OBP (CDER)
— Office of Biotechnology Products (CDER)
CIO
— Chief Information Officer
CV
— Cardiovascular
RFI
— Request For Information. Sales department shorthand. Special priority when use in conjunction with RFN (see below).
FBI
— Federal Bureau of Investigation
DVM
— Doctor of Veterinary Medicine
DNR
— Do Not Resuscitate
NCR
— Non-Conformance Report
FR
— Federal Register
COBRA
— Consolidated Omnibus Budget Reconciliation Act of 1985
SACX
— Secretary's Advisory Committee on Xenotransplantation
OMB
— Office of Management and Budget (U.S.)
AABB
— American Association of Blood Banks
ADA
— Americans With Disabilities Act Of 1990 (Text Of ADA Legislation)
DAAP (CDER)
— Division of Anesthesia and Analgesia Products (CDER)
WYSIWYG
— What You See Is What You Get (pronounced Wizzy-wig. See Entry For Derived Acronyms)
TB
— Tuberculosis
HMO
— Health Maintenance Organization
CONUS
— Continental United States (48 Contiguous States and DC)
M2 EWG
— ICH M2 Expert Working Group
QIS-P
— Quality Information Summary - Pharmaceuticals
DNA
— Deoxyribose Nucleic Acid
NIST
— National Institute of Standards and Technology
CGI
— Common Gateway Interface
P&PC
— Production and Process Control
D0AF (CDRH)
— Division of Planning, Analysis and Finance (CDRH)
NSN
— National Stock Number
BUN
— Blood Urea Nitrogen
AAR
— After Action Review
CFO
— Communication Filing Officer
DAC (CFSAN)
— Division of of Analytical Chemistry (CFSAN)
RDBMS
— Relational Database Management System
DL
— Deciliter
EEOC
— Equal Employment Opportunity Commission
TAB (OC)
— Travel Audit Branch (OC)
E-ARCH
— Extended Adult Residential Care Home
RACT (CFSAN)
— Risk Assessment Coordination Team (CFSAN)
WAT (CFSAN)
— Worklife Analysis Team (CFSAN)
CSF
— Cerebrospinal Fluid
C-CDA
— Consolidated - Clinical Document Architecture
ANZFA
— Australia New Zealand Food Authority (now Food Standards Australia New Zealand)
DA (OC)
— Division of Accounting (OC)
℮
— estimated
CAD
— Coronary Artery Disease
QAS (CBER)
— Quality Assurance Staff (CBER)
UCBU
— Umbilical Cord Blood Unit
NGO
— Non-governmental organization. (Red Cross/Crescent, Doctors without Borders, etc.)
ASD
— Atrial Septal Defect
IUPAC
— International Union of Pure and Applied Chemistry
IAB (ORA)
— Infrastructure Applications Branch (ORA)
AS
— Aortic Stenosis
DAFM (CVM)
— Division of Animal and Food Microbiology (CVM)
BARS (CDER)
— Business Analysis and Reporting Staff (CDER)
DOJ
— Department of Justice (US)
CAB (OC)
— Computer Applications Branch (OC)
DADS (CDER)
— Division of Applications Development and Services (CDER)
FACS (CFSAN)
— Food Advisory Committee Staff (CFSAN)
EEG
— Electro-EncephaloGram
EAB (CFSAN)
— Exposure Assessment Branch (CFSAN)
SAR
— Search And Rescue
DAS (NCTR)
— Division of Administrative Services (NCTR)
ᄃ
— Section; shorthand symbol used to designate a section in a legal document
QAT (CBER)
— Quality Assurance Team (CBER)
RA
— Rheumatoid Arthritis
ICAO
— International Civil Aviation Organization
DAS (CFSAN)
— Division of Administrative Services Management (CFSAN)
TEAE
— Treatment-Emergent Adverse Event
FARMINDU STRIA
— Association of Italian Pharmaceutical Manufacturers
HAB (CFSAN)
— Hazard Assessment Branch (CFSAN)
HQ
— Headquarters (HDQ Preferred)
NCCLS
— National Committee for Clinical Laboratory Standards
IAB (CDRH)
— Information and Analysis Branch (CDRH)
EFT
— Electronic Funds Transfer
MAB (CFSAN)
— Methods Application Branch (CFSAN)
IAS (OC)
— International Agreements Staff (OC)
BX
— Biopsy
FOIA
— Freedom of Information Act
FACTS@FDA
— system for electronically communicating approved drug labeling and for disseminating prescribing information
TAB (CDRH)
— Technical Assistance Branch (CDRH)
CMC
— Chemical Manufacturing Control
M4 EWG
— ICH M4 Expert Working Group
DAEA II
— Division of Adverse Event Analysis 2
ANA
— Antinuclear Antibody
MACS (CBER)
— Manufacturers Assistance and Communications Staff (CBER)
EO
— Executive Order
OCAC (CFSAN)
— Office of Cosmetics and Colors (CFSAN)
ARF
— Acute Renal Failure
DJD
— Degenerative Joint Disease
OC (CDRH)
— Office of Compliance (CDRH)
IAMFES
— International Association of Milk, Food and Environmental Sanitarians
LOV
— List Of Values
EAS (CDER)
— Enterprise Architecture Staff (CDER)
QAU (CFSAN)
— Quality Assurance Unit (CFSAN)
OBRR (CBER)
— Office of Blood Research and Review (CBER)
OC (CDER)
— Office of Compliance (CDER)
OAGS (OC)
— Officeof Acquisitions and Grants Services (OC)
LANGUAL
— Langua Alimentaria (Language of Foods)
DBMS
— Database Management System
CRF
— Chronic Renal Failure
OCD (CDRH)
— Office of the Center Director (CDRH)
PAB (CFSAN)
— Product Adulteration Branch (CFSAN)
DAE (OC)
— Division of Applied Engineering (OC)
J/D
— Judgment for the Defendant
DARRTS
— Document Archiving, Reporting, and Regulatory Tracking System
OCBQ (CBER)
— Office of Compliance and Biologics Quality (CBER)
EEC
— European Economic Community (predecessor of the European Union|EU)
OB (CDER)
— Office of Biostatistics (CDER)
OCD (CVM)
— Office of the Center Director (CVM)
FAO
— Food and Agriculture Organization of the United Nations
DHR
— Device History Record
DAF (CVM)
— Division of Animal Feeds (CVM)
AAAS
— American Association for the Advancement of Science
ᄃᄃ
— Sections; shorthand symbol used to designate sections in a legal document
LOA
— Letter Of Agreement
OAP (CDER)
— Office of Antimicrobial Products (CDER)
VBPV
— Vegetative Bacteria, Protozoa, and Viruses
USGS
— United States Geological Survey (DOI)
MAB (CDER)
— Management Analysis Branch (CDER)
HGB
— Hemoglobin
OC (CFSAN)
— Office of Compliance (CFSAN)
GSA
— U.S. General Services Administration
NAET (CFSAN)
— Nutrition Assessment and Evaluation Team (CFSAN)
ICU
— Intensive Care Unit
T/PT
— Traceability/Product Tracing
C
— with (usually written with a bar on top of the "c")
NTIS
— National Technical Information Service Technology Administration
CRS
— Congressional Research Service
PAIS (ORA)
— Public Affairs and Information Staff (ORA)
DAGID (CDRH)
— Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (CDRH)
OBFP (OC)
— Office of Budget Formulation and Presentation (OC)
OCD (CFSAN)
— Office of the Center Director (CFSAN)
DAR (CVM)
— Division of Animal Research (CVM)
S/NDS
— Supplemental / New Drug Submission
UN
— United Narions
OARSA (CFSAN)
— Office of Applied Research and Safety Assessment (CFSAN)
DAIOP (CDER)
— Division of Anti-infective and Ophthalmology Products (CDER)
OBPS (CDER)
— Office of Business Process Support (CDER)
DEA
— Drug Enforcement Administration (U.S. Department of Justice)
IMO
— International Maritime Organization
CPAP
— Continuous Positive Airway Pressure
AHU
— Air Handling Unit
OBQI/M
— Outcome-Based Quality Improvement/Monitoring
CC
— Chief Complaint
QMS
— Quality Management System
MACMIS
— Marketing, Advertising and Communication Management Information System
FAEMS
— Foods Adverse Event Monitoring System
DAPR (CDER)
— Division of Applied Pharmacology Research (CDER)
NHLBI
— National Heart, Lung, and Blood Institute
BPR
— Business Process Re-engineering
OBES (OC)
— Office of Business Enterprise Solutions (OC)
RSS (CDER)
— Regulatory Support Staff (CDER)
LF
— Low Frequency
J-ART
— Japanese Adverse Reaction Terminology
RRSS (CDER)
— Regulatory Review Support Staff (CDER)
IATA
— International Air Transport Association
HAZMAT
— Hazardous Material
LOD
— Limit Of Detection
MTD
— Maximum Tolerated Dose (that does not produce unacceptable toxicity)
TDY
— temporary duty (non-unit-related personnel)
EANDA
— Electronic Abbreviated New Drug Application
GMP
— Good Manufacturing Practice
GAO
— Government Accountability Office [formerly the General Accounting Office]
OPM
— Office of Personnel Management
SES
— Senior Executive Service
ARC
— American Red Cross
IDP
— Individual Development Plan
COOP
— Continuity of Operations
MCO
— Managed Care Organization
TPN
— Total Parenteral Nutrition
PPP
— Point-to-Point Protocol
EMC
— Electromagnetic Compatibility
ADR
— Adverse Drug Reaction
HCT
— Hematocrit
CACBERS
— Committee for the Advancement of CBER Science
GU
— Genitourinary
NPI
— National Provider Identifier
RNA
— Ribo Nucleic Acid
CIA
— Central Intelligence Agency
AAP
— American Academy of Pediatrics
W3C
— World Wide Web Consortium
FAPMC
— Food Animal Production Medicine Consortium
ALARA
— As Low As Reasonably Achievable
DAILYMED
— NLM-based database of information on marketed drugs including FDA-approved labels.
CRO
— Contract Research Organization
APHIS
— U.S. Department of Agriculture's Animal and Plant Health Inspection Service
º
— section û shorthand symbol used to designate a section in a legal document; as in º201(m) of the FD&
CM
— Configuration Management
BLM
— Bureau of Land Management of United States Department of the Interior
NSC
— National Security Council
DKA
— Diabetic Ketoacidosis
IVP
— Intravenous Pyelogram
MDV
— Medical Device Vigilance
I&O
— Intake & Output
ME
— Medical Examiner
ERP
— Enterprise Resource Planning
ECL
— Electrochemiluminescence
COP
— Continuation Of Pay
PVC
— Polyvinyl Chloride
AQL
— Acceptable Quality Level
JPEG
— Joint Photographic Experts Group (24-bit image storage format)
FTC
— Federal Trade Commission (U.S.)
AVMA
— American Veterinary Medical Association
NOS
— Network Operating System
AMS
— Aseptic Meningitis Syndrome
RTF
— Rich Text Format
BPA
— Blanket Purchase Agreement
AAO
— American Academy of Ophthalmology
CMV
— Cytomegalovirus
ADA
— American Dental Association
SSA
— Social Security Administration
OAI
— Official Action Indicated (serious Food & Drug Administration post-inspection classification)
AAEP
— American Association of Equine Practitioners
OASDI
— Old Age Survivors Disability Insurance
(B)(4)
— Freedom of Information Act Exemption 4, which protects from disclosure ôtrade secrets and commercial
BEA
— Bureau of Economic Analysis
AML
— Acute Myelogenous Leukemia
DUNS
— Data Universal Numbering System
ARDS
— Acute Respiratory Distress Syndrome
FECA
— Federal Employee's Compensation Act
BMI
— Body Mass Index
IAW
— In Accordance With
ECRF
— Electronic Case Report Form
PER DIEM
— Per Day allowance for daily travel expenses
CRCL
— Creatinine Clearance
BMR
— Basal Metabolic Rate
CJD
— Creutzfeldt-Jakob Disease
AUC
— Area under the Curve (statistics)
C&S
— Culture and Sensitivity
COI
— Conflict Of Interest
CHIP
— Children's Health Insurance Program
PIN
— Personal Identification Number
WFI
— Water For Injection (pharmaceutical Term)
QOL
— Quality of Life
A2LA
— American Association for Laboratory Accreditation
TNTC
— Too Numerous To Count
AIS
— Automated Information System
ERT
— Emergency Response Team
ADME
— absorption, distribution, metabolism, and excretion
HTN
— Hypertension
MBC
— Minimum Bactericidal Concentration
SEC
— Securities and Exchange Commission (US)
SIDS
— Sudden Infant Death Syndrome
MI
— Myocardial Infarction
SSRI
— Selective Serotonin Reuptake Inhibitor
AHA
— American Hospital Association
USPS
— United States Postal Services
PCR
— Polymerase Chain Reaction
PNR
— Passenger Name Record
HCG
— Human Chorionic Gonadotropin
EFTA
— European Free Trade Association (Geneva)
NBS
— National Bureau of Standards (US)
HCFA
— Health Care Financing Administration
CHO
— Carbohydrate
ARRT
— American Registry of Radiologic Technologists
OPV
— Oral Polio Vaccine
CAPD
— Continuous Ambulatory Peritoneal Dialysis
OLE
— Object Linking and Embedding (Microsoft communication protocol)
Y2K
— Year 2000
BSA
— Body Surface Area
SWAT
— Special Weapons and Tactics
FAT
— Factory Acceptance Test
ABPI
— Association of the British Pharmaceutical Industry
ALJ
— Administrative Law Judge
DI
— Diabetes Insipidus
DME
— Durable Medical Equipment
USC
— United States Code (book of laws)
EBS
— Emergency Broadcast System
CRF
— Case Report Form
ITA
— International Trade Administration
PHI
— Protected Health Information
CVD
— Cardiovascular Disease
ISS/ISE
— Integrated Summary of Safety / Integrated Summary of Effectiveness
TCP/IP
— transmission control protocol/internet protocol
TRO
— Temporary Restraining Order
AACR
— American Association for Cancer Research
CME
— Continuing Medical Education
AFP
— Alpha Fetoprotein
NAFTA
— North American Free Trade Agreement
ESD
— Electrostatic Discharge
ECE
— Economische Commissie voor Europa (United Nations) (Dutch: Economic Commission for Europe)
ALT
— Alanine Aminotransferase
FASAB
— Federal Accounting Standards Advisory Board
IPCS
— International Programme on Chemical Safety
BNA
— Bureau of National Affairs, Inc.
FBS
— fasting blood sugar
ELISA
— enzyme-linked immunosorbent assay
CDRH
— Center for Devices and Radiological Health (Food & Drug Administration)
DCC
— Document Control Center
AAFP
— American Academy of Family Physicians
I&D
— Incision and Drainage
EC
— European Community
IVF
— in vitro fertilization;
AASP
— American Association of Swine Practitioners
FERC
— Federal Energy Regulatory Commission (U.S.)
AANS
— American Association of Neurological Surgeons
CRA
— Clinical Research Associate
NHANES
— National Health and Nutrition Examination Survey
NCE
— New Chemical Entity
NCC MERP
— National Coordinating Council for Medication Error Reporting and Prevention
AST
— Aspartate Aminotransferase
APHA
— American Public Health Association
AE
— Adverse Event
CRP
— Cold Reactive Protein
ODI
— Oswestry Disability Index
ASM
— American Society for Microbiology
CPE
— Continuing Professional Educational
AABP
— American Association of Bovine Practitioners
MRP
— material requirements planning
CONOPS
— Concept of Operations
CE
— Continuing Education
CPK
— Creatinine Phosphokinase
AAPM
— American Association of Physicists in Medicine's
CAPA
— Corrective And Preventive Action
CHD
— Coronary Heart Disease
AALAS
— American Association for Laboratory Animal Science
T&A
— Time & Attendance
ACG
— American College of Gastroenterology
AASRP
— American Association of Small Ruminant Practitioners
TLC
— Thin Layer Chromatography
NEC
— not elsewhere classified
482
— FDA form for notice of inspection
NTIA
— National Telecommunications and Information Administration
FERS
— Federal Employees Retirement System
PKI
— Public Key Infrastructure (cryptography)
DNS
— Domain Name Server
ICS
— Incident command system
BPD
— Bronchopulmonary Dysplasia
BIA
— Bureau of Indian Affairs (U.S.)
DHHS
— Department of Health and Human Services (U.S.)
SPC
— Summary of Product Characteristics
AAI
— American Association of Immunologists
ORNL
— Oak Ridge National Laboratory's
HCO
— Health Care Organization
CSR
— Clinical Study Report
ULN
— upper limit of normal
BBB
— Bundle Branch Block
TSP
— Thrift Savings Plan
TOC
— Total Organic Carbon
NOD
— Notice of Deficiency
PHS
— Public Health Service (U.S.)
TSH
— thyroid stimulating hormone
HDPE
— High Density Polyethylene Electrical
OPO
— Organ Procurement Organization
AHCPR
— Agency for Health Care Policy and Research
SAMHSA
— Substance Abuse and Mental Health Services Administration
MIC
— Minimum Inhibitory Concentration
DC
— discontinue
PUD
— Peptic Ulcer Disease
IDDM
— insulin-dependent diabetes mellitus
ATSDR
— Agency for Toxic Substance and Disease Registry
DC
— Discharge
PR
— Public Relations
AAVMC
— Association of American Veterinary Medical Colleges
CBG
— Capillary Blood Gas
AFIA
— American Feed Industry Association
RX
— prescriptions
SIP
— Sterilization in Place
SQ
— Subcutaneous
VMS
— Virtual Memory System
EAR
— Export Administration Regulations
NASA
— National Aeronautics and Space Administration (US)
CEA
— Council of Economic Advisors
SAL
— Sterility Assurance Level
HX
— Medical History
ALL
— Acute Lymphocytic Leukemia
ORR
— Objective Response Rate
USP
— United States Pharmacopeia
AODM
— Adult-Onset Diabetes Mellitus
HBP
— High Blood Pressure
NS
— Not Significant
UMDNS
— Universal Medical Device Nomenclature System
USA
— United States Army
APIC
— Active Pharmaceutical Ingredients Committee (of CEFIC)
CP
— Cerebral Palsy of New Jersey
DMARD
— disease-modifying antirheumatic drug
WBC
— White blood cells
ASBPO
— Armed Services Blood Program Office
PPTP
— Point-to-Point Tunneling Protocol
IRDM
— Insulin Resistant Diabetes Mellitus
ADAP
— AIDS Drug Assistance Program
HHS
— U.S. Department of Health and Human Services
OSTP
— Office of Science and Technology Policy
ADAMHA
— Alcohol, Drug Abuse, and Mental Health Administration (now SAMHSA)
CCC
— Commodity Credit Corporation
USCG
— United States Coast Guard
510(K)
— Food, Drug, and Cosmetic Act Section 501(k), Pre-Market Notification
RH
— Relative Humidity
OOB
— OOS out of business
ARS
— United States Department of Agriculture's Agricultural Research Service
NMFS
— National Marine Fisheries Services
BSL
— Biosafety Level
FTT
— Failure To Thrive
DMR
— Device Master Record
ACIP
— Advisory Committee on Immunization Practices
FOUO
— For Official Use Only
BOS (CBER)
— Building Operations Staff (CBER)
SHOP
— Small Business Health Options Program
NTG
— Nitroglycerin
SBIR
— Small Business Innovation Research
SAE
— Serious Adverse Event
SMPC
— Summary of Product Characteristics
NABR
— National Association for Biomedical Research
CMP
— Civil Money Penalty
CIR
— Cosmetic Ingredient Review
CPT
— Current Procedural Terminology
HDL
— High-Density Lipoprotein (a type of cholesterol)
LOCF
— Last Observation Carried Forward
SBA
— Small Business Administrations
CEQ
— Council on Environmental Quality (U.S.)
CCC
— Chinese ceramicware factory code (ORA AofC code)
NWS
— National Weather Service (formerly U.S. Weather Bureau)
NAI
— No Action Indicated (Most Favorable Food & Drug Administration Post-inspection Classification)
SC
— Subcutaneous
AAVLD
— American Association of Veterinary Laboratory Diagnosticians
TMJ
— TemporoMandibular Joint (syndrome)
RSS
— Really Simple Syndication
IMS
— Information Management System (LTPP)
QNS
— Quantity Not Sufficient
BRFSS
— Behavioral Risk Factor Surveillance System
FMRI
— Functional Magnetic Resonance Imaging
ANPRM
— Advance Notice of Proposed Rule Making
EH & S
— environmental health and safety
DES
— diethyl sulphate
EEA
— European Economic Area
MDR
— Medical Device Reporting
RIA
— Radio Immuno-Assay
RUO
— Research Use Only
TVA
— Tennessee Valley Authority (US) (electricity)
CFOC
— Chief Financial Officers Council
CI
— Confidential Informant
FDA BLA
— Food and Drug Administration - Biologicals License Application
PBM
— Pharmacy Benefits Management (or Manager)
QHS
— quaque hora somni (every night at bedtime)
VHA
— Veterans Health Administration's
DIA
— Drug Information Association
SAR
— Specific Absorption Rate
ASHD
— AtheroSclerotic Heart Disease
CRO
— Clinical Research Organization
PNNL
— Pacific Northwest National Laboratory (DOE) (US)
PIM
— Product Information Management
DMF
— Drug Master File
A-V
— ArterioVenous
LD
— Lethal Dose
COLD
— Chronic Obstructive Lung Disease
JTF
— Joint Task Force
NOC
— National Operations Center
ANDA
— Abbreviated New Drug Application (for a generic drug)
DIA
— Defense Intelligence Agency (USA)
QWL
— Quality of Work Life
CAP
— College of American Pathologists
ASR
— Analyte Specific Reagent
RDA
— Recommended Daily Allowance
ACF
— Administration for Children and Families
SF
— Standard Form
AAAP
— American Association of Avian Pathologists
ASIC
— Application Specific Integrated Circuit
AAHA
— American Animal Hospital Association
IIS
— Internet Information Services
FMECA
— failure modes, effects, and criticality analysis
CO
— Compliance Officer
LSD
— Lysergic Acid Diethylamide
PDCA
— Plan-do-check-action
NARA
— United States National Archives And Records Administration
HA
— Headache
KCAL
— kilocalories
DLI
— Donor Lymphocyte Infusion
PHRMA
— Pharmaceutical Research and Manufacturers of America (formerly PMA, Pharmaceutical Manufacturers Association)
EINECS
— European Inventory Of Existing Commercial Chemical Substances
FONSI
— Finding of no significant impact. See Environmental impact statement (US)
AVDA
— American Veterinary Distributors Association
DVD
— Digital Video Disc
DSMB
— Data Safety Monitoring Board
21 CFR PART 314 SUBPART H
— Subpart of Part 314 pertaining to accelerated approval of drugs
GLP
— Good Laboratory Practice
IV&V
— independent verification and validation
CPP
— Critical Process Parameter
IACUC
— Institutional Animal Care and Use Committee
CEF
— chick embryo fibroblast
NCI
— National Cancer Institute, USA
ARENA
— Applied Research Ethics National Association
GCP
— Good Clinical Practice
APHA
— American Pharmaceutical Association
CCR
— Center for Cancer Research
HAV
— Hepatitis A Virus
MSSO
— Maintenance and Support Services Organization
SRD
— System Requirements Document
GM
— Genetic Modification
BW
— Body Weight
PADER
— Periodic Adverse Drug Experience Report
BMS (OC)
— Broadcast Media Staff (OC)
CCU
— Clean Catch Urine
CRADA
— Cooperative Research and Development Agreement (with National Institutes of Health)
NTP
— National Toxicology Program
NICE
— National Institute for Health and Clinical Excellence
CP
— Chest Pain
VAX
— Virtual Address Extension
SX
— syndrome X
ASCP
— American Society for Clinical Pathology
RVU
— Relative Value Unit
IRM
— Information Resources Management
NCBA
— National Cattlemen's Beef Association
TDI
— Tolerable Daily Intake
NPR
— National Performance Review (office)
FNS
— Food and Nutrition Service
IG
— Inspector General (HHS)
EMV
— eye-motor-verbal (Glasgow coma scale)
CFDA
— Catalog of Federal Domestic Assistance
IND
— Investigational New Drug
USAID
— United States Agency for International Development
CERT
— Community Emergency Response Team
PAO
— Public Affairs Officer
EMI
— Electro-Magnetic Interference
DOI
— Department of the Interior (US)
FPS
— Federal Protective Service
QS
— Quality System
GEP
— Good Engineering Practice
NHC
— United States National Hurricane Center
MTBF
— Mean Time Between Failures
CGL
— Chronic Granulocytic Leukemia
USAHA
— United States Animal Health Association's
BSI
— British Standards Institute
AD LIB
— As Much As Needed
LGA
— large for gestational age
EPFA
— European Plasma Fractionation Association
HFA
— HydroFluoroAlkane
CINAHL
— Cumulative Index to Nursing and Allied Health Literature
IB
— Investigator's Brochure
CN
— Cranial Nerve
CAP
— Corrective Action Plan
ANA
— Administration for Native Americans
CAB
— Conformity Assessment Body
TLA
— Three-Letter Acronym
DIBD
— Development International Birth Date
LOQ
— Limit Of Quantification
NIEHS
— National Institute of Environmental Health Sciences (National Institutes of Health)
TRB
— Technical Review Board (MRR)
SNDA
— Supplemental New Drug Application
TDD
— Telecommunications Device for the Deaf
HVAC
— Heating, Ventilating, And Air Conditioning
CDER
— Center for Drug Evaluation and Research (Food & Drug Administration)
SARS
— Severe Acute Respiratory Syndrome
REMS:
— Risk Evaluation and Mitigation Strategies
ICRP
— International Commission on Radiological Protection
ODAC
— Oncologic Drugs Advisory Committee (U.S.)
CVA
— Costovertebral Angle
MDI
— Metered-Dose Inhaler
NASDA
— National Association of State Departments of Agriculture
NICHD
— National Institute of Child Health and Human Development
AERS
— Adverse Event Reporting System (Food & Drug Administration)
NDC
— National Drug Code
PART
— Program Assessment Rating Tool
IBD
— International Birth Date
MAC
— Mental Adjustment to Cancer Scale
CIOMS
— Council for International Organizations of Medical Sciences
ICMJE
— International Committee of Medical Journal Editors
GDS
— Global Distribution System
SGA
— small for gestational age
LMO
— Living Modified Organism
PFGE
— Pulsed-Field Gel Electrophoresis
CTFA
— Cosmetic, Toiletry, and Fragrance Association
SUSAR
— Suspected Unexpected Serious Adverse Reactions
DODAAC
— Department Of Defense Activity Address Code
CTC
— Common Toxicity Criteria
DVT
— Deep Venous Thrombosis
MOD 1
— Module One laboratory facility
AADA
— Abbreviated Antibiotic Drug Application
EDMS
— Electronic Document Management System
GHTF
— Global Harmonization Task Force
BIO
— Biotechnology Industry Organization
FEI
— FDA Establishment Identifier (ORA)
CSR
— Center for Scientific Review
WHO
— World Health Organisation
ANPR
— Advance Notice of Proposed Rulemaking
DESI
— Drug Efficacy Study Implementation Notice (Food & Drug Administration, to evaluate drugs in use befaore 1962)
CRB
— Change Review Board
AV
— Atrio-Ventricular (cardiac)
RBRVS
— Resource-Based Relative Value Scale
NCCDPHP
— National Center for Chronic Disease Prevention and Health Promotion
CEU
— Continuing Education Units
NACMCF
— National Advisory Committee on Microbiological Criteria for Foods
FDLI
— Food and Drug Law Institute
HCI
— Human-Computer Interaction
CHMP
— Committee for Medicinal Products for Human Use
AID
— Agency for International Development (U.S.)
FFS
— Fee-For-Service
BFAD
— Bureau of Food & Drug Administration
WB
— Western Blot
DUR
— Drug Utilization Review
AANN
— American Association of Neurosciences Nurses
API
— Active Pharmaceutical Ingredient
DART
— Developmental And Reproductive Toxicology (database / base de données)
CSB
— Chemical Safety and Hazard Investigation Board
R-CHOP
— Drug combination that includes rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
AFGE
— American Federation of Government Employees
ACR
— American College of Radiology
AMS
— Agricultural Marketing Service
IEEE
— Institute of Electrical and Electronics Engineers
CIP
— Critical Infrastructure Protection (US)
LIMS
— Laboratory Information Management System
PKU
— Phenylketonuria
CAS
— Chemical Abstract Service
NVLAP
— National Voluntary Laboratory Accreditation Program
RFA
— Request For Application
CBER
— Center for Biologics Evaluation and Research
HIM
— Health Information Management
INCI
— International Nomenclature of Cosmetic Ingredients
FORM 482
— Notice Of Inspection
OVR
— Operations Variance Report
TSE
— Transmissible Spongiform Encephalopathies
HIMA
— Health Industry Manufacturers Association
SEER
— Surveillance, Epidemiology, and End Results
SRS
— Spontaneous Reporting System
NIA
— National Institute on Aging
JCAHO
— Joint Commission on Accreditation of Health Care Organizations
GS
— General Schedule
CMA
— Chemical Manufacturers Association
FACA
— Federal Advisory Committee Act 1972
PERV
— Porcine Endogenous Retrovirus
UL
— Underwriters Laboratories
SDS-PAGE
— Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis
CTCAE
— Common Terminology Criteria for Adverse Events
BAM
— Bacteriological Analytical Manual
WHO-ART
— World Health Organisation Adverse Reaction Terminology
RCT
— randomized controlled trial
QSR
— Quality System Regulation
VAI
— Voluntary Action Indicated (Food & Drug Administration postaudit inspection classification)
ENL
— Erythema Nodosum Leprosum
HRSA
— U.S. Health Resources and Services Administration
JECFA
— Joint (FAO/WHO) Expert Committee on Food Additives
IHS
— Indian Health Service
BATF
— Bureau of Alcohol, Tobacco, & Firearms
MEDPAC
— Medicare Payment Advisory Commission
ADMS
— Alcohol, Drug Abuse and Mental Health Services
TSCA
— Toxic Substances Control Act of 1976
FDASS (OC)
— FDA Safety Staff (OC)
NCRP
— National Council on Radiation Protection and Measurements
E2B
— FDA Working Group that defined Efficacy Topics' Data Elements for Transmission of Adverse Drug Reactions Reports
OASH
— Office of the Assistant Secretary for Health
EFD
— Engineering Flow Diagram
PCS
— Permanent Change Of Station. Reassignment To A Different Duty Station.
PFS
— Piper Fatigue Scale
NIGMS
— National Institute Of General Medical Sciences (NIH)
ETOH
— Ethyl Alcohol (Ethanol)
TRI
— Toxics Release Inventory
JAD
— Joint Application Development
EKG
— electrocardiogram
NIMS
— National Incident Management System
CFU
— Colony Forming Unit (for Bacteria Counting In Water Disinfection)
SMO
— Site Management Organization
USIA
— United States Information Agency (changed To IIP)
HTML
— Hyper-Text Markup Language
OQ
— Operational Qualification
CPSC
— Consumer Product Safety Commission
INDA
— Investigational New Drug Application
QAO
— Quality Assurance Office
PTU
— Propylthiouracil
UIN
— Unique Identification Number
CASE
— Computer-Aided Software Engineering
LS/LS
— Life Supporting/Life Sustaining
DFAS
— Defense Finance & Accounting Service
PETA
— People for the Ethical Treatment of Animals
CIT
— Center for Information Technology
CFC
— Combined Federal Campaign
USCA
— United States Code Annotated
DILI
— drug-induced liver injury
ABI
— Automated Broker Interface
ADVAMED
— Advanced Medical Technology Association
CRC
— Clinical Research Coordinator
MF
— Master File
DSUR
— Development Safety Update Report
FTS
— Federal Telecommunications System
SRM
— Specified Risk Material
NCHS
— National Center for Health Statistics standards
SHE
— Safety, Health and Environmental
BLA
— Biologics License Application (Food & Drug Administration)
ONC
— Office of the National Coordinator for Health Information Technology (United States Government Health and Human Services)
JIC
— Joint Information Center
DTC
— Direct-to-Consumer (drug advertising)
NCBI
— National Center for Biotechnology Information
PWS
— Performance Work Statement
EHR
— Electronic Health Record
LAF
— Laminar Air Flow
GMDN
— Global Medical Device Nomenclature
ICF
— Informed Consent Form
CGMP
— current Good manufacturing practicess
LES
— Leave and Earnings Statement
CTD
— Common Technical Document
GAP
— Good Agricultural Practice
DICOM
— Digital Imaging and Communications in Medicine
ERC
— Engineering Research Center
EH&S
— Environmental Health and Safety
TRALI
— transfusion-related acute lung injury
NEHA
— National Environmental Health Association
NAL
— National Agricultural Library
NEI
— National Eye Institute (National Institutes of Health)
CHPA
— Consumer Healthcare Products Association
NIDA
— National Institute on Drug Abuse (National Institutes of Health)
GCLP
— Good Clinical Laboratory Practice
ABCS
— Active Bacterial Core Surveillance
ACEP
— American College of Emergency Physicians
OIP
— Office of International Programs
CFG
— Certificate for Foreign Government
PMAP
— Performance Management Appraisal Program
QCP
— Quality Control Program
TOI
— Trial Outcome Index
AL
— Annual Leave
SNL
— Sandia National Laboratories
VSD
— Vaccine Safety Datalink
FARAD
— Food Animal Residue Avoidance Databank
STEPS
— System for Thalidomide Education and Prescribing Safety
IPV
— Inactivated Polio Vaccine
A/L
— Annual Leave
NACDS
— National Association of Chain Drug Stores
DURSA
— Data Use and Reciprocal Support Agreement
PK
— Pharmacokinetics
URS
— User Requirement Specification
ADP
— Alternative Disposition Plan
FASEB
— Federation of American Societies for Experimental Biology's
FDASIA
— Food and Drug Administration Safety and Innovation Act
FQ
— Fluoroquinolone
USCS
— United States Customs Service
ASA
— Aminosalicylic Acid
SOPP
— Standard Operating Procedures and Policies
SCOGS
— Select Committee On GRAS (Generally Recognized As Safe) Substances
FOI
— Freedom of Information
CIAC
— Computer Incident Advisory Capability
ASA
— American Statistical Association
RSS
— Rich Site Summary
ASAP
— Administrative Systems Automation Project (Food & Drug Administration)
CIN
— Color Index number (ORA AofC code)
ICD
— Informed Consent Document
CTC
— Chlortetracycline
BB IND
— Biological-Based Investigational New Drug
MDMA
— Medical Device Manufacturers Association
USP-DI
— United States Pharmacopeia-Drug Information
MMWR
— Morbidity and Mortality Weekly Report
POV
— Privately-Owned Vehicle. A Soldier's Personal Automobile.
CPCSEA
— Committee for the Purpose of Control and Supervision on Experiments on Animals (India)
AOA
— Administration on Aging
NETBEUI
— NETBIOS Extended User Interface
HFD
— Headquarters, FDA Drug; mail code for Center for Drug Evaluation and Research
QSAR
— Quantitative Structure Activity Relationship
USPSTF
— United States Preventive Services Task Force
DAWN
— (U.S.) Drug Abuse Warning Network
CAMP
— Childhood Asthma Management Program
COP
— Clean Out of Place
MMA
— Medicare Prescription Drug, Improvement and Modernization Act of 2003
ERCP
— Endoscopic Retrograde Cholangio-pancreatography Procedures
MEDEC
— Medical Devices Canada
ASCO
— American Society of Clinical Oncology's
VFD
— Veterinary Feed Directive
OOS
— Out Of Specification
ORANGE BOOK
— Approved Drug Products with Therapeutic Equivalence Evaluations
CSTE
— Council of State & Territorial Epidemiologists
SPAC
— State Pharmaceutical Administration of China
MMR
— measles, mumps, and rubella
MERP
— Medication Error Reporting and Prevention
ICH
— International Conference on Harmonization (of Technical Requirements for Registration of Pharmaceuticals for Human Use)
AHF
— Antihemophilic Factor
ASGE
— American Society for Gastrointestinal Endoscopy
AIM
— Active Ingredient Manufacturer
TESS
— Treatment-Emergent Signs and Symptoms
RRCC
— Regional Response Coordination Center
CNS
— Congress of Neurological Surgeons
NIDCR
— National Institute of Dental and Craniofacial Research
MTCT
— mother-to-child transmission
KOS
— Knowledge Organization System
HHMI
— Howard Hughes Medical Institute
RPSGB
— Royal Pharmaceutical Society of Great Britain
VADM
— Vice Admiral
D & C
— Dilation and Curettage
VMP
— Validation Master Plan
NHIN
— Nationwide Health Information Network
EFPIA
— European Federation of Pharmaceutical Industries and Associations
CWD
— Chronic Wasting Disease
VEE
— Venezuelan Equine Encephalomyelitis
TROIF
— Total Recordable Occupational Illness Frequency
AWP
— Average Wholesale Price
OSHRC
— Occupational Safety and Health Review Commission
USACE
— United States Army Corps of Engineers
FSH
— Follicular Stimulating Hormone
SPECT
— single-photon emission computed tomography
AMFAR
— American Foundation for AIDS Research
ETASU
— Elements To Assure Safe Use
FACT
— Functional Assessment of Cancer Therapy--General
NIBIB
— National Institute of Biomedical Imaging and Bioengineering
DPT
— Diphtheria, Pertussis And Tetanus
COE
— Center of Excellence
SRCS
— Division of Surveillance, Research, and Communication Support
ICRU
— International Commission on Radiation Units and Measurements
SG
— Surgeon General
GXP
— Good "x" Practices (x = any type of practice)
APLB (CBER)
— Advertising and Promotional Labeling Branch (Center for Biologics Evaluation and Research)
BGA
— BundesGesundheitsAmt (German Federal Health Office)
LOAEL
— Lowest Observed Adverse Effect Level
NGA
— National Geospatial-Intelligence Agency (formerly National Imagery and Mapping Agency; US government)
ECU
— European Currency Unit
EWG
— Expert Working Group
BCPT
— Breast Cancer Prevention Trial
DBRA
— Division of Biometry and Risk Assessment
SDO
— Standards Development Organization
ORISE
— Oak Ridge Institute for Science and Education
CITES
— Convention on International Trade in Endangered Species of Wild Fauna and Flora
ASTHO
— Association of State and Territorial Health Officials
GHC
— Group Health Cooperative
CSR
— Customer Service Record
DCU
— Document Control Unit
SSED
— Summary of Safety and Effectiveness Data
LRI
— Lower Respiratory Infection
NBII
— National Biological Information Infrastructure
DAL
— Defect Action Level
ADMC
— Advance Determination of Medicare Coverage
NIAAA
— National Institute on Alcohol Abuse and Alcoholism
RDNA
— Recombinant Deoxyribonucleic Acid
QSIT
— Quality System Inspection Technique
PACE
— Patient-centered Assessment and Counseling for Exercise
DGFPS
— Direccion General de Farmacia y Productos Sanitarios (Directorate General of Pharmacy and Sanitary Products) (Spain)
DPAMS
— Division of Pre-marketing Assessment III and Manufacturing Science
TVC
— Total Viable Count
CATCH
— Child and Adolescent Trial for Cardiovascular Health
OGE
— Office of Government Ethics (formerly part of Office of Personnel Managment, separate executive branch in 1989)
OCR
— Office of Civil Rights
PERI
— Pharmaceutical Education & Research Institute
HPFB
— Health Products and Food Branch (Canada)
KS
— Kaposi's Sarcoma
FFDCA
— Federal Food, Drug and Cosmetic Act of 1938
IMPD
— Investigational Medicinal Product Dossier (EU)
CRMTS
— CBER (Center for Biologics Evaluation and Research) Regulatory Meetings management Tracking System
N.B.
— nota bene (note well)
DRLM
— Device Registration and Listing Module (FURLS)
MFCU
— Medicaid Fraud Control Unit
EAA
— essential amino acidsolution
USPTO
— United States Patent and Trademark Office
ARCRT
— American Registry of Clinical Radiography Technologists
CBP
— Customs and Border Protection
RM
— Raw Material
NACCHO
— National Association of County and City Health Officials
DWPE
— Detention without Physical Examination
HL7
— Health Level 7 (a not-for-profit ANSI-accredited standards-developing organization (SDO)
IQ
— Installation Qualification
GIS
— Geographical Information System
SCD
— Service Computation Date
BT ACT
— Bioterrorism Act (Public Health Security and Bioterrorism Preparedness and Response Act of 2002)
ORI
— Office of Research Integrity
DNP (CDER)
— Division of Neurology Products (Center for Drug Evaluation and Research)
ACS (CDER)
— Advisors and Consultants Staff (Center for Drug Evaluation and Research)
CRCPD
— Conference of Radiation Control Program Directors
STAMP
— Systematic Technology Assessment of Medical Products
ED
— Effective Dose
URL
— Uniform Resource Locator
AC
— Advisory Committee
CEFIC
— Conseil Européen des Fédérations de l'Industrie Chimique (European Chemical Industry Council
HSA
— Health Services Administration
RR
— Relative risk of death
NLEM
— National List of Essential Medicines
CA
— Chemical Abstracts
PDMP
— Prescription Drug Monitoring Program
FCCSET
— Federal Coordinating Council for Science, Engineering, and Technology
LF3
— Low-value Foor or Food-related products, level 3 (between $500 and $1000)
HCTZ
— Hydrochlorothiazide
DMAT
— Disaster Medical Assistance Team
SIP
— Summer Internship Program
LRC
— Lipid Research Clinic
VAERS
— Vaccine Adverse Event Reporting System
BPCI ACT
— Biologics Price Competition and Innovation Act of 2009
HAART
— Highly Active Antiretroviral Therapy ヨ the name commonly given to combinations of anti-HIV drugs
FFLA
— Family Friendly Leave Act
NCEH
— National Center for Environmental Health
HSPD
— Homeland Security Presidential Directive
HEPA
— High-Efficiency Particulate Air filter
OIT (CDER)
— Office of Information Technology (Center for Drug Evaluation and Research)
NIS
— National Inpatient Sample
MRL
— Maximum Residue Limit
PDB (CDER)
— Prescription Drugs Branch (Center for Drug Evaluation and Research)
PHPPO
— Public Health Practice Program Office
HRG
— Health Research Group
FAERS
— FDA Adverse Event Reporting System
SUPAC-IR
— Scale-Up and Post-Approval Changes - Immediate Release
EAS
— Emergency Alert System
AAFCO
— Association of American Feed Control Officials
BPE
— Bulk Pharmaceutical Excipients
ORP (CDER)
— Office of Regulatory Policy (Center for Drug Evaluation and Research)
FEB
— Federal Executive Board
GME
— Graduate Medical Education
BECON
— Bioengineering Consortium
ASPE
— Assistant Secretary for Planning and Evaluation
NSAPB
— National Surgical Adjuvant Breast and Bowel Project
BPAC
— Blood Products Advisory Committee
PARQ
— Physical Activity Readiness Questionnaire
COA
— Certificate of Analysis
CRL
— Complete Response Letter
QP
— Qualified Person
ABC
— American Blood Commission
EDIPI
— Electronic Data Interchange Personal Identifier
AWS
— Alternate Work Schedule
PDO
— Protected Designation of Origin
FD&C ACT
— Federal Food, Drug, and Cosmetic Act of 1938
NARB
— National Advertising Review Board
CSV
— Computer System Validation
AT
— antithrombin III
BVB
— Bacterial Vaccine and Allergenic Products Branch
NCDC
— National Centre for Disease Control, India
DV
— Daily Values
TTTC
— Take Time To Care
CIRMS
— Council on Ionizing Radiation Measurements and Standards
DCPS
— Defense Civilian Pay System
ACRPI
— Association of Clinical Research for the Pharmaceutical Industry
NIOSH
— National Institute for Occupational Safety and Health (CDC)
NCHSTP
— National Center for HIV, STD, & TB Prevention
AMP
— Average Manufacturer Price
JINAD
— Generic Investigational New Animal Drug File
SCLIR
— Secondary Calibration Laboratories for Ionizing Radiation
FPLA
— Fair Packaging and Labeling Act of 1967
OPDP
— Office of Prescription Drug Promotion (CDER) (formerly Division of Drug Marketing, Advertisement and
OM (CDER)
— Office of Management (Center for Drug Evaluation and Research)
SCR
— System Change Request
CMP/ HMO
— Comprehensive Medical Plan/Health Maintenance Organization
NIDDK
— National Institute of Diabetes and Digestive and Kidney Diseases
GRAS
— Generally Recognized As Safe
ATC
— Anatomical Therapeutic Chemical
IARC
— International Agency for Research on Cancer
COS
— Certificate of Suitability
LOC
— Level Of Concern
DONED
— Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices (CDRH)
ADEERS
— Adverse Event Expedited Reporting System
DIT (CDRH)
— Division of Information Technology (Center for Drug Evaluation and Research)
MQSA
— Mammography Quality Standards Act of 1992
SBRS
— SENIOR BIOMEDICAL RESEARCH SERVICE
DCPA (CBER)
— Division of Congressional and Public Affairs (Center for Biologics Evaluation and Research)
ESF
— Emergency Support Function
BOCF
— Baseline Observation Carried Forward
OD
— Office of the Director
DTAP
— diphtheria, tetanus and acellular pertussis
PHA
— Public Health Advisory
JBIG
— Joint Bi-level Image experts Group
APAP
— N-Acetyl-Para-Amino-Phenol
GIF
— Graphics Interchange Format
PCP
— Pneumocystis Carinii Pneumoniae
AATB
— American Association of Tissue Banks
NVP
— National Vaccine Program
EP
— European Pharmacopoeia
AOB (OC)
— Accounting Operations Branch (OC)
OWH (OC)
— Office of Women's Health (OC)
ACPM
— American College of Preventive Medicine
HTLV
— human T-lymphotropic viruse
EDMF
— European Drug Master File
NS/EP
— National Security and Emergency Preparedness
COLA
— Cost Of Living Allowance
C
— Gl With Correction
BIVAS
— Body Image Visual Analog Scale
MLD
— Minimum Lethal Dose
ER
— Extended-Release
CC
— Coordinating Committee
EPAR
— European Public Assessment Report
CDA
— Clinical Document Architecture
CEARS
— CBER (Center for Biologics Evaluation and Research) Error and Accident Reporting System
NUCC
— National Uniform Claim Committee
RAD
— Rapid Application Design
3500A
— FDA form for mandatory reporting of adverse events
ISSO
— Information Systems Security Officer
ESIG
— Electronic Signature
M4
— ICH M4 Expert Working Group (EWG) [focusing on Common Technical Documents for sections of the NDA]
AE(S)
— adverse event(s)
AUSA
— Assistant United States Attorney
OP (OC)
— Office of Policy (Office of the Commissioner)
TSCSB (CFSAN)
— Telecommunications and Scientific Computer Support Branch (CFSAN)
OP 2 (OC)
— Operations Team 2 (OC)
C
— Gl With Glasses
S/L
— Sick Leave
CDC
— Centers for Disease Control and Prevention
OIT (CBER)
— Office of Information Technology (Center for Biologics Evaluation and Research)
FALCPA
— Food Allergen Labeling and Consumer Protection Act
SSOP
— Sanitation Standard Operating Procedures
ACS (CBER)
— Analytical Chemistry Staff (Center for Biologics Evaluation and Research)
FFD & C
— Federal Food, Drug and Cosmetic Act of 1938
RAMP
— Remedial Action Management Program
ADE/ADER
— Adverse Drug Experience/Adverse Drug Experience Report
NLEA
— Nutrition Labeling and Education Act of 1990
C/CC
— Career or Career Conditional
2301
— FDA form for transmittal of periodic reports and promotional material for new animal drugs
STN
— Submission Tracking Number
MCAFT
— Modified Canadian Aerobic Fitness Test
ABN
— Advance Beneficiary Notice
ACBSA
— Advisory Committee on Blood Safety and Availability
DFO
— Designated Federal Official
USJFCOM
— United States Joint Forces Command
CDASH
— Clinical Data Acquisition Standards Harmonization
USRDS
— United States Renal Data System
CAPAR
— Corrective Action Preventive Action Report
SECT 505(B)(2)
— New drug application
SUPAC-SS
— scale-up and postapproval changes--nonsterile solid
CEB (CFSAN)
— Compliance and Enforcement Branch (CFSAN)
TEB (CBER)
— Therapeutics Evaluation Branch (CBER)
SCARP
— Supplier Corrective Action Report
CTA
— Clinical Trial Agreement
C-TPAT
— Customs-Trade Partnership Against Terrorism
MUMS ACT
— Minor Use and Minor Species Animal Health Act of 2004
CA
— Competent Authority
DIN
— Drug Identification Number
TCS
— Temporary Change of Station
DHSS
— Department of Health and Social Security (U.K.)
SAP
— Service Access Point
KPS
— Karnofsky Performance Status scale
RCR
— Replication Competent Retrovirus
QMIS
— Quality Management Information System
WFH
— World Federation of Hemophilia
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)
DAA
— Designated Approving Authority
WITS
— Washington Interagency Telecommunications System
VVB (CBER)
— Viral Vaccines Branch (CBER)
ACP
— Advance Care Planning
CAAT
— Center for Alternatives to Animal Testing
SUBPART H
— That subpart of 21 CFR Part 314 pertaining to accelerated approval of drugs
AIMBE
— American Institute For Medical and Biological Engineering
BRAPP
— British Association of Pharmaceutical Physicians
PA
— Physical Activity
CGTP
— Current Good Tissue Practice
ISBT 128
— International Society of Blood Transfusion standard for blood, tissue, and organ identification
DHCP
— Dear Health Care Professional
CT
— Clinical Trial
BISTIC
— Biomedical Information Science and Technology Initiative Consortium
COTA
— Career Opportunities Training Agreement (HHS)
SBOA
— Summary Basis of Approval
PDCS (OC)
— Policy Development and Coordination Staff (OC)
CLSI
— Clinical and Laboratory Standards Institute
RPMS (OC)
— Regulations Policy and Management Staff (OC)
GXT
— graded exercise tolerance (Stress test)
PEB (CBER)
— Planning and Evaluation Branch (CBER)
FORM 3500A
— Mandatory Reporting of Adverse Events
CIP
— Clean-In-Place
OSHA
— Occupational Safety and Health Administration (U.S. Department of Labor)
RMB (CBER)
— Resource Management Branch (CBER)
CIB (CFSAN)
— Compliance Information Branch (CFSAN)
OM (OC)
— Office of Management (Immediate Office of the Commissioner)
NMA
— National Medical Association
EPC
— Evidence-based Practice Center
SID
— Source-to-Image Distance
APHL
— Association of Public Health Laboratories
CPB (CFSAN)
— Compliance Programs Branch (CFSAN)
MAH
— Marketing Authorization Holder
OPB (ORA)
— Operations and Policy Branch (Office of Regulatory Affairs)
PADE
— Postmarketing Adverse Drug Experience
BARDA
— Biomedical Advanced Research and Development Authority
DNCE (CDER)
— Division of Nonprescripton Clinical Evaluation (CDER)
WG
— Wage Grade
OS (OC)
— Operations Staff (OC)
DDDP (CDER)
— Division of Dermatology and Dental Products (CDER)
DHF
— Design History File
ITIPS
— Information Technology Investment Portfolio System
C OF A
— Certificate of Analysis
PMN
— Pre-Market Notification
ACGME
— Accreditation Council for Graduate Medical Education
CHCB (CFSAN)
— Chemical Contaminants Branch (CFSAN)
UPLC
— Ultra Performance Liquid Chromatography
ODM
— Operational Data Model
ORTF
— Obesity Research Task Force
GBL
— Government Bill of Lading
MA
— Marketing Authorization
FSANZ
— Food Standards Australia New Zealand's
DDES (CFSAN)
— Division of Dairy and Egg Safety (CFSAN)
PDE
— Permitted Daily Exposure
NCCAM
— National Center for Complementary and Alternative Medicine
C & S
— Culture and Sensitivity
HDF
— mail code for CDER (Center for Drug Evaluation and Research)
MOD 2
— Module Two laboratory facility
CHAMPVA
— Civilian Health And Medical Program Of The Department Of Veterans Affairs
DRLS
— Drug Registration and Listing System
ENTB (CDRH)
— Ear, Nose, and Throat Devices Branch (CDRH)
PEB (ORA)
— Program Evaluation Branch (ORA)
IFT
— Institute of Food Technologists
CSM
— Committee on Safety of Medicines
NLT
— Not Less Than
CTEB (CFSAN)
— Cosmetics Technology Branch (CFSAN)
CBIAC
— Chemical and Biological Defense Information Analysis Center
1932A
— FDA form for veterinary adverse drug reaction, lack of effectiveness, product defect report--voluntary
LOEL
— Lowest Observed Effect Level
NCTR
— National Center for Toxicological Research
SPCS (CDER)
— Safety Policy and Communications Staff (CDER)
ECT
— Electro-Convulsive Therapy
PEB 1 (CDRH)
— Postmarket Evaluation Branch 1 (Center for Devices and Radiological Health)
OBE
— Online Booking Engine
ASD (HD)
— Assistant Secretary of Defense for Homeland Defense
FSMS
— Food Safety Management System
NCDCP
— National Council on Prescription Drug Programs
MEG
— Magnetoencephalography
PQRI
— Product Quality Research Institute
OIT (ORA)
— Office of Information Technology (Office of Regulatory Affairs)
ICCBBA
— International Council for Commonality in Blood Banking Automation, Inc.
WONF
— With Other Natural Flavors
CTDB 1 (CDRH)
— Chemistry and Toxicology Devices Branch 1 (CDRH)
NHW
— National Health and Welfare Department (Canada's equivalent of DHHS)
ADRAC
— Adverse Drug Reactions Advisory Committee
QBD
— Quality by Design
CDM
— Clinical Data Management
SEIU
— Service Employees International Union
CPGM
— Compliance Program Guidance Manual
BCB (CFSAN)
— Bioanalytical Chemistry Branch (CFSAN)
OM (CBER)
— Office of Management (Center for Biologics Evaluation and Research)
OCP (OC)
— Office of Combination Products (OC)
SOC
— System Organ Classification
DSHEA
— Dietary Supplement and Health Education Act of 1994
OVST (CFSAN)
— Operations and Veterinary Support Team (CFSAN)
DFS (ORA)
— Division of Field Science (ORA)
DIHD (CDRH)
— Division of Immunology and Hematology Devices (CDRH)
FERN
— Food Emergency Response Network
IBR (CFSAN)
— Import Branch (CFSAN)
CODEX
— Codex Alimentarius collection of food standards
AAPHP
— American Association of Public Health Physicians
FORM 348
— Sponsored Travel
OIT (OC)
— Office of Information Technology (Immediate Office of the Commissioner)
CMS
— Centers for Medicare and Medicaid Services (formerly Health Care Financing Administration)
CSV
— Comma Separated Values file format
TEACA
— Trolox-Equivalent Antioxidant Capacity Assay
X-SCID
— X-linked severe combined immunodeficiency disorder
CRMT (OC)
— Cosmetics Toxicology Branch (CFSAN)
HFS
— Headquarters, FDA Safety; mail code for Center for Food Safety and Applied Nutrition
CDISC
— Clinical Data Interchange Standards Consortium (formerly a DIA special interest group called the Clinical Data Interchange Standards Committee)
LR1
— Low-value non-prescription Radiation-emitting products, level 1 (less than $200)
DESE (CDRH)
— Division of Electrical and Software Engineering (CDRH)
CDSA
— Controlled Drugs and Substances Act (Canada)
DPEM (ORA)
— Division of Planning, Evaluation and Management (ORA)
QD
— Quaque in Die (once daily)
GRASE
— Generally Recognized As Safe and Effective
ER/ES
— Electronic Records/Electronic Signatures
DES
— Drug Eluting Stent
AIP
— Application Integrity Policy
ACLAM
— American College of Laboratory Animal Medicine
BOCB (CFSAN)
— Biological and Organic Chemistry Branch (CFSAN)
ACSM
— American College of Sports Medicine's
WRAIR
— Walter Reed Army Institute of Research
BMB (CFSAN)
— Bioanalytical Methods Branch (CFSAN)
QL
— Quality of Life
COOP
— Continuity of Operations Procedure
DSMICA
— Division of Small Manufacturers, International and Consumer Assistance (FDA)
CLIA
— Clinical Laboratory Improvement Amendment
PIC
— Pharmaceutical Inspection Convention
DPL
— Drug Product Licensing (Canada)
FDA-WO
— Food and Drug Administration White Oak campus
HHI
— Herth Hope Index
CLT
— Central Limit Theorem
AMPI
— Associated Milk Producers Inc.
IGIV
— Immune Globulin Intravenous
QMS (CDER)
— Quality Management Staff (CDER)
VCJD
— Variant Creutzfeldt-Jakob Disease
CMGB (CDER)
— Cae Management and Guidance Branch (CDER)
FAN
— Food Allergy Network
BP
— British Pharmacopoeia
QIJ
— Quality Inspection Journal
NCL
— National Consumers League
NF
— National Formulary
OSG
— Office of the Surgeon General
OLA (OC)
— Office of Legislative Affairs (Office of the Commissioner)
ISAC
— Information Sharing and Analysis Center
RSO
— Radiation Safety Officer
OEO (OC)
— Office of Executive Operations (OC)
ERB (CFSAN)
— Elemental Research Branch (CFSAN)
OIVD (CDRH)
— Office of In Vitro Diagnostic Device Evaluation and Safety (CDRH)
WISQARS
— Web-based Injury Statistics Query and Reporting System
FDARA
— Food and Drug Administration Revitalization Act
TRX
— Total number of Prescriptions
DPS
— Division of Post-marketing Surveillance
348
— FDA form for sponsored travel
BIRAMS
— Biologics Investigational and Related Applications Management System
BVC
— British Veterinary Codex
DEB (CFAN)
— Dairy and Egg Branch (CFSAN)
VMB (CFSAN)
— Virulence Mechanisms Branch (CFSAN)
QID
— Quater In Die (Four Times a Day)
BPL
— Biologic Product License Number
PNSI
— Prior Notice System Interface
ACCME
— Accreditation Council for Continuing Medical Education
SPR
— System Problem Report
WPADP
— Working Party on Automation and Data Processing
FTE
— Full-Time Equivalent
OITSS (OC)
— Office of Information Technology Shared Services (Immediate Office of the Commissioner)
DPAMS (CDER)
— Division of Pre-marketing Assessment III and Manufacturing Science (CDER)
FDCA
— Federal Food, Drug, and Cosmetic Act of 1938
PBSC
— Peripheral Blood Stem Cell
DCLD (CDRH)
— Division of Clinical Laboratory Devices (CDRH)
FORM 356V
— New Animal Drug Application
OSC (CVM)
— Office of Surveillance and Compliance (CVM)
DCB (CFSAN)
— Domestic Compliance Branch (CFSAN)
NMDP
— National Marrow Donor Program
OFPA
— Organic Foods Production Act of 1990
CO
— Commissioned Officer
GMID
— Global Market Information Database
CCRC
— Certified Clinical Research Coordinator
ECTD
— Electronic Common Technical Document
RPMCC
— Regulatory Project Management Coordinating Committee (CDER)
ASRM
— American Society for Reproductive Medicine
DD (CVM)
— District Director (Center for Veterinary Medicine)
WAE
— When Actually Employed
CHSB (CFSAN)
— Chemical Hazards Science Branch (CFSAN)
OER (OC)
— Office of External Relations (OC)
ACLA
— American Clinical Laboratory Association
BFARM
— Bundesinstitut Fur Arzneimittel und Medizinprodukte (German Ministry of Health)
TV
— Travel Voucher
DMIP
— Division of Medical Imaging Products (CDER)
CFN
— Central File Number
FLETC
— Federal Law Enforcement Training Center
DP
— Drug Product
CTDB 1
— Chemistry and Toxicology Devices Branch 1
ITB (CFSAN)
— Immunotoxicology Branch (CFSAN)
ASAS
— American Society of Animal Science
BPC
— Bulk Pharmaceutical Chemical
OSO
— Office of Security Operations
CCP
— Critical Control Point
TOPRA
— The Organisation for Professionals in Regulatory Affairs
GPRD
— General Practice Research Database
DMIRDP (CDER)
— Division of Medical Imaging and Radiopharmaceutical Drug Products (CDER)
AER
— Adverse Event Reporting
CCB (CFSAN)
— Color Certification Branch (CFSAN)
DGSS (CFSAN)
— Division of General Scientific Support (CFSAN)
DPE (CDER)
— Division of Post-marketing Development (CDER)
DDM (NCTR)
— Deputy Director for Management (National Center for Toxicological Research)
TPLC
— Total Product Life Cycle
CSPI
— Center for Science in the Public Interest
NOEL
— no observed effect level
IMCC
— Information Management Coordinating Committee
S&E
— Safety and Effectiveness
DIMS (OC)
— Division of Infrastructure Management and Services (OC)
DIAM (CDRH)
— Division of Imaging and Applied Mathematics (CDRH)
HAM/TSP
— HTLV-I-associated myelopathy / tropical spastic paraparesis
DTP
— Direct-to-Patient
BARQA
— British Association of Research Quality Assurance
CSO
— Consumer Safety Officer
GOVTRIP
— government travel website operated by Northrop Grumman
AAALAC
— Association for the Assessment and Accreditation of Laboratory Animal Care International
IO
— Immediate Office
UFMS
— Unified Financial Management System
ACPE
— Accreditation Council for Pharmacy Education
PAP
— Patient Assistance Program
BSC
— Biological Safety Cabinet
ACE
— Automated Commercial Environment (US Customs)
DRARD (CDRH)
— Division of Reproductive, Abdominal and Radiological Devices (CDRH)
FDC
— Food Drug and Cosmetic
SCSB (CFSAN)
— Scientific Computer Support Branch (CFSAN)
CUE
— Confidential Unit Exclusion
HHS SERT
— Health and Human Services Secretary's Emergency Response Team
BID
— Bis In Die (Twice Daily)
PEB 2 (CDRH)
— Postmarket Evaluation Branch 2 (Center for Devices and Radiological Health)
ADAA
— Animal Drug Availability Act of 1996
CPID
— Certified Product Information Document (Canada)
EUP
— Experimental Use Permit
FQPA
— Food Quality Protection Act of 1996
CCBC
— Council of Community Blood Centers
CTIA
— Cellular Telecommunications and Internet Association's
PEB (CDRH)
— Program Enforcement Branch (CDRH)
U
— Units
PSSB (CFSAN)
— Program Support Services Branch (CFSAN)
POB
— Program Operations Branch
CS
— Civil Service
PAHO
— Pan American Health Organization
DCIQA (ORA)
— Division of Compliance Information and Quality Assurance (ORA)
AOAC
— Association of Official Analytical Chemists
PAS (CDRH)
— Premarket Approval Section (CDRH)
DDMS (CDER)
— Division of Database Management and Services (CDER)
OND (CDER)
— Office of New Drugs (CDER)
PAI
— Pre-Approval Inspection
FPB (CDRH)
— Field Programs Branch (Center for Devices and Radiological Health)
EDIFACT
— Electronic Data Interchange for Administration, Commerce, and Transportation
TDDS
— Transdermal Drug Delivery System
SPTPB (CFSAN)
— Seafood Processing and Technology Policy Branch (CFSAN)
CIAO
— Critical Infrastructure Assurance Office
ADRM
— Associate Director for Review Management
WMS (OC)
— Website Management Staff (OC)
OCS
— Office of the Chief of Staff
AASA
— Aging and Adult Services Administration
RIBAル
— recombinant immunoblot assay (Chiron ᆴ)
MAPP
— Manual of Policy and Procedures
SC (CDRH)
— Staff College (Center for Devices and Radiological Health)
PHIN
— Public Health Information Network
PTS (CBER)
— Product Testing Section (CBER)
GTL (NCTR)
— Genetic Toxicology Laboratory (NCTR)
USTR
— United States Trade Representative
ACLAD
— American Committee on Laboratory Animal Diseases
483
— FDA form used as a written notice of deficiencies found in inspections
CTDB 2
— Chemistry and Toxicology Devices Branch 2
SL
— Signature Line
CTAP
— Career Transition Assistance Plan
PQG
— Pharmaceutical Quality Group
CRB (CBER)
— Clinical Review Branch (CBER)
EIND
— Electronic Investigational New Drug Application (US Food and Drug Administration)
PUFI
— Packed Under Federal Inspection
BIOB (CFSAN)
— Biostatistics Branch (CFSAN)
DMIHP (CDER)
— Division of Medical Imaging and Hematology Products (CDER)
BSC
— Business Service Center
SMCC
— Standards Management Coordinating Committee
SDAB (CDER)
— Surveillance and Data Analysis Branch (CDER)
PHPS
— Public Health Prevention Service
APTF
— Application Policy Task Force
CAERST (CFSAN)
— CFSAN Adverse Event Reporting System Team
STS (CBER)
— Standards and Testing Staff (CBER)
NINR
— National Institute of Nursing Research
DPD (OC)
— Division of Portfolio Development (OC)
FOB
— Federal Office Building
ACIL
— A national trade asociation representing independent, commerical scientific, and engineering firms (formerly the American Council of Independent Laboratories)
AMI
— American Meat Institute
ELEXNET
— Electronic Laboratory Exchange Network
CIS
— Cancer Information Service
INV SAMPLE
— INVestigational Sample
COB (OC)
— Contract Operations Branch (Office of the Commissioner)
IMS (CDRH)
— Issues Management Staff (CDRH)
POA
— privately owned automobile
HCCN
— Health Center-Controlled Network
FD-1932
— FDA form, Veterinary Adverse Drug Reaction, lack of effectiveness, product defect report - Mandatory
COOP
— Continuity of Operations Program
USFDA
— United States Food & Drug Administration
JPMA
— Japan Pharmaceutical Manufacturers Association
BGH
— Bovine Growth Hormone
VSB (CBER)
— Vaccine Safety Branch (CBER)
CFSAN
— Center for Food Safety and Applied Nutrition
DHC
— dioxin health certificate (ORA AofC code)
HFZ
— Headquarters, FDA code Z; mail code for Center for Devices and Radiological Health
CPMP
— Committee for Proprietary Medicinal Products
APIFARMA
— Associação Portuguesa da Indústria FARMAcêutica (Association of the Portuguese Pharmaceutical Industries)
CRTP
— Clinical Research Training Program
TURBO EIR
— Turbo Establishment Inspection Report (ORA)
AEA
— Actual Expense Allowance
PN
— Product Name
OPHEP
— Office of Public Health Emergency Preparedness
NOAEL
— No Observable Adverse Effect Level
PPE
— Pay Period Ending
PDCS
— Policy Development and Coordination Staff
PCBS
— polychlorinated biphenyls
CTDB 2 (CDRH)
— Chemistry and Toxicology Devices Branch 2 (CDRH)
FDERA
— Food and Drug Export Reform and Enhancement Act of 1996
LWC
— Lead Wire or patient Cable
FTB (CFSAN)
— Food Technology Branch (CFSAN)
CAPLAR
— Computer-Assisted Product License Application Review
CAPRA
— Canadian Association of Professional Regulatory Affairs
IMLS
— Institute of Museum and Library Services
NACHO
— National Association of County Health Officials
OOPD
— Office of Orphan Product Development (FDA)
QOD
— Quaque Altere Die (take every other day)
NALBOH
— National Association of Local Boards of Health
TTY
— TeleTYpewriter
BPHC
— Bureau of Primary Health Care
PTO
— Patent and Trademark Office (U.S. Department of Commerce)
SPIE
— International Society for Optical Engineering
COOP
— Continuity of Operations Policy
GEBAT
— Government Excess Baggage Authorization Ticket
BIMO
— bioresearch monitoring
USBR
— Bureau of Reclamation (U.S. Department of the Interior)
ODE I
— Office of Drug Evaluation I (CDER)
DIVBT (CFSAN)
— Division of In Vitro and Biochemical Toxicology (CFSAN)
DRFDD (ORA)
— Deputy Regional Food and Drug Director (ORA)
RLD
— Reference Listed Drug
DCRER (CFSAN)
— Division of Chemistry Research and Environmental Review (CFSAN)
ODE III
— Office of Drug Evaluation III (CDER)
MSS (CVM)
— Management Support Staff (CDRH)
VMO
— Veterinary Medical Officer
CAPLA
— Computer-Assisted Product License Application
DPMU
— Disaster Portable Morgue Unit
BDB (CDRH)
— Bacteriology Devices Branch (CDRH)
RAE
— Remedial Action Exemption
GINAD
— Generic Investigational New Animal Drug file
WSL (CFSAN)
— Washington Seafood Laboratory (CFSAN)
JTR
— Joint Travel Regulations
ECDT
— Electronic Common Technical Document
SMSB (CFSAN)
— Spectroscopy and Mass Spectrometry Branch (CFSAN)
DDMAC (CDER)
— Division of Drug Marketing, Advertising and Communication (CDER)
DEB
— Dairy and Egg Branch
OPPL (OC)
— Office of Policy, Planning and Legislation (OC)
DAAS
— Division of Aging and Adult Services
LOB (ORA)
— Laboratory Operations Branch (ORA)
CFIA
— Canadian Food Inspection Agency
FDAMA
— Food and Drug Administration Modernization Act of 1997
SNOMED-RT
— Systematized Nomenclature of Medicine Reference Terminology
AIMDD
— Active Implantable Medical Device Directive
DRP (CBER)
— Division of Regulations and Policy (CBER)
ISMP
— Institute for Safe Medication Practices
ACRA (ORA)
— Associate Commissioner for Regulatory Affairs (ORA)
AHIC
— American Health Information Community
EOC
— Emergency Operations Center (FDA)
DPDD (CDER)
— Division of Pediatric Drug Development (CDER)
TID
— three times a day
ACRA
— Associate Commissioner for Regulatory Affairs (Food & Drug Administration)
NATAG
— North American Technical Advisory Group
NEMA
— National Emergency Management Association
MAPCB (CDER)
— Manufacturing Assessment & Pre-Approval Compliance Branch (CDER)
ICCVAM
— Inter-agency Coordinating Committee on Validation of Alternative Methods
CCST (CFSAN)
— Clinical Chemistry Support Team (CFSAN)
DRB (CBER)
— Devices Review Branch (CBER)
OCER (CDRH)
— Office of Communication, Education and Radiological Programs (CDRH)
MVB (CFSAN)
— Molecular Virology Branch (CFSAN)
MAD
— Multiple Ascending Dose
ABIFARMA
— Brazilian Association of the Pharmaceutical Industry
OCI (ORA)
— Office of Criminal Investigations (ORA)
PB (CFSAN)
— Pathology Branch (Center for Food Safety and Applied Nutrition)
OSHC (OC)
— Office of Science and Health Coordination (OC)
MRB (CFSAN)
— Methods Research Branch (Center for Food Safety and Applied Nutrition)
NDE/MIS
— New Drug Evaluation Management Information System
3RS
— Recruitment and Relocation Bonuses and Retention Allowances
OS (CDER)
— Operations Staff (CDER)
TSA
— Transportation Security Administration
EFOIA
— Electronic Freedom of Information Act
PFO
— Principal Federal Official
SMDA
— Safe Medical Devices Act of 1990
AFIP
— Armed Forces Institute of Pathology (DoD)
EDRLS
— Electronic Drug Registration and Listing Systems
HNK CELLS
— human neonatal kidney cells
ALJ (OC)
— Office of the Administrative Law Judge (OC)
OPS (CDER)
— Office of Pharmaceutical Science (CDER)
DPAP (CDER)
— Division of Pulmonary and Allergy Products (CDER)
PPQ
— Plant Protection and Quarantine
DDOP (CDER)
— Division of Drug Oncology Products (CDER)
DBEC (OC)
— Division of Budget Execution and Control (OC)
GCPB I (CDER)
— Good Clinical Practice Branch I (CDER)
INADA
— Investigational New Animal Drug Application
OP 1 (OC)
— Operations Team 1 (OC)
OEL
— Occupational Exposure Level
BI
— Boehringer Ingelheim
NIFC
— National Interagency Fire Center
DNP (CFSAN)
— Division of Natural Products (Center for Food Safety and Applied Nutrition)
DSP (OC)
— Division of Strategic Projects (OC)
DSST (CFSAN)
— Division of Seafood Science and Technology (CFSAN)
RU-486
— Roussel Uclaf drug number 486
US & R
— urban search and rescue
GCSL (CFSAN)
— Gulf Coast Seafood Laboratory (Dauphin Island, Alabama) (CFSAN)
CCFAC
— Codex Committee on Food Additives and Contaminants
M2
— ICH M2 Expert Working Group (EWG) [electronic standards for transmission of regulatory information]
OM (CVM)
— Office of Management (Center for Veterinary Medicine)
1932
— FDA form for veterinary adverse drug reaction, lack of effectiveness, product defect report--mandatory
DDSPC (CFSAN)
— Division of Dietary Supplement Programs and Compliance (CFSAN)
OVRR (CBER)
— Office of Vaccines Research and Review (CBER)
PERT
— Product-enhanced Reverse Transcriptase
DCGM (OC)
— Division of Contracts and Grants Management (OC)
VEB (CBER)
— Vaccine Evaluation Branch (CBER)
FASS
— Federation of Animal Science Societies
TO
— Transportation Officer
DPEB (CBER)
— Division of Planning, Evaluation and Budget (CBER)
OSD-HD
— Office of the Secretary of Defense for Homeland Defense
RADAR
— Risk Assessment of Drugs Analysis and Response
MSU
— Medical Statistics Unit
AMG
— ArzeneiMittelGesetz (West Germany drug law)
NEDSS
— National Electronic Disease Surveillance System
IFIC
— International Food Information Council
NPCC
— National Poison Control Center
ACB (CDRH)
— Accreditation and Certification Branch (CDRH)
DATS
— Document Accountability and Tracking System
DRMP (CDER)
— Division of Review Management and Policy (CDER)
QSI
— Quality Step Increase
OHRMS
— Office of Human Resources and Management Services
ASLAP
— American Society of Laboratory Animal Practitioners
FURLS
— FDA Uniform Registration & Listing System
USITC
— United States International Trade Commission
CMGB
— Cae Management and Guidance Branch
ADCOM
— ADvisory COMmittee
DNPL (CFSAN)
— Division of Nutrition Programs and Labeling (Center for Food Safety and Applied Nutrition)
LNE
— Laboratoire National de Metrologie et d'Essias (National Laboratory of Metrology and Essays)
ICE
— Immigration and Customs Enforcement (Department of Homeland Security)
IUO
— investigation use only
ITS (CBER)
— Information Technology Staff (CBER)
DPFRM (CFSAN)
— Division of Planning and Financial Resources Management (CFSAN)
ES
— Effect Size
DFEM (NCTR)
— Division of Facilities Engineering and Maintenance (NCTR)
EMOPS (OC)
— Office of Emergency Operations (OC)
USFS
— United States Forest Service (U.S. Department of Agriculture)
RODS
— Real-Time Outbreak & Disease Surveillance System
WIN
— Welfare Information Network
CSB (OC)
— Customer Support Branch (Office of the Commissioner)
CCVDF
— Codex Committee on Veterinary Drugs in Foods
CNPP
— USDA Center for Nutrition Policy and Promotion
CISET
— Committee on International Science Engineering and Technology
IPOAB (CDRH)
— Information Processing and Office Automation Branch (CDRH)
CTEP
— Cancer Therapy Evaluation Program
TAS (NCTR)
— Technology Advancement Staff (NCTR)
SPCS
— Safety Policy and Communications Staff
OSHI (OC)
— Office of Special Health Issues (OC)
ºº
— sections û shorthand symbol used to designate sections in a legal document; as in ºº201(m), 301(k) o
DSORD
— Division of Surgical, Orthopedic, and Restorative Devices
ICDR
— Interagency Committee on Disability Research
BLS
— Biologics License Supplement
BC/BS
— Blue Cross and Blue Shield
BRMD
— Bureau of Radiation and Medical Devices
ANA
— Abbreviated New Animal drug number
ADRP
— Association of Donor Recruitment Professionals
DCF
— Data Clarification request Form
AB (CDRH)
— Analysis Branch (CDRH)
IRMC
— Information Resources Management College
SOAB (OC)
— Systems and Office Automation Branch (Immediate Office of the Commissioner)
DEMO (CDRH)
— Division of Ethics and Management Operations (CDRH)
LTSS
— Long-Term Services and Supports
CI/KR
— Critical Infrastructure and Key Resources
WOC II
— Woodmont Office Complex II (South)
CHLIA
— chemi-luminescent immunoassay
IB (CFSAN)
— Immunobiology Branch (CFSAN)
ICD-9-CM
— International Classification of Diseases, Ninth Revision, Clinical Modification
DHRD (ORA)
— Division of Human Resources Development (ORA)
DCRP (CDER)
— Division of Cardiovascular and Renal Products (CDER)
FAM
— Foreign Affairs Manual
ANADA
— Abbreviated New Animal Drug Application
ICL
— idiopathic CD4 T-lymphocytopenia
IIG
— Inactive Ingredient Guide
DDRE (CDER)
— Division of Drug Risk Evaluation (CDER)
LNC
— Labeling and Nomenclature Committee
ACCP
— American College of Clinical Pharmacology
FCO
— Federal Coordinating Officer (in disaster areas)
CFA
— Catfish Farmers of America
OO (CFSAN)
— Office of Operations (CFSAN)
C & R
— corrections and removals
PMOA
— Primary Mode Of Action
DTBIMP (CDER)
— Division of Therapeutic Biological Internal Medicine Products (CDER)
OP 3 (OC)
— Operations Team 3 (OC)
NMT
— Not More Than
DTD (CDER)
— Division of Training and Development (CDER)
DMEP (CDER)
— Division of Metabolism and Endocrinology Products (CDER)
ROC
— receiver operating characteristic curve
DMEPA (CDER)
— Division of Medical Error Prevention and Analysis
PELT (CFSAN)
— Product Evaluation and Labeling Team (CFSAN)
NNMC
— National Naval Medical Center
DMETS (CDER)
— Division of Medical Errors and Technical Support (CDER)
SAPB (CFSAN)
— Shellfish and Aquaculture Policy Branch (CFSAN)
GSFA
— General Standard for Food Additives
DPD (CVM)
— Division of Production Drugs (CVM)
BGMA
— British Generic Manufacturers Association
WPS (OC)
— Workforce Programs Staff (OC)
SRD
— Swine Respiratory Disease
DCRMS (CDER)
— Division of Compliance Risk Management and Surveillance (CDER)
DOED (CDRH)
— Division of Ophthalmic, Ear, Nose and Throat Devices (CDRH)
EMAC
— Emergency Management Assistance Compact
ACMP
— American College of Medical Physics
ET (CFSAN)
— Education Team (CFSAN)
GTIB (CBER)
— Gene Transfer and Immunogenicity Branch (CBER)
MIS (OC)
— Management Initiatives Staff (OC)
DRF
— Dose Range Findings
EML
— Environmental Measurement Laboratory
AND
— Abbreviated New Drug application number
SSB
— Systems Support Branch
NEP
— National Exercise Program
RMAB (CDRH)
— Risk Management and Analysis Branch (CDRH)
ODE II
— Office of Drug Evaluation II (CDER)
NDF-RT
— National Drug File Reference Terminology
ENG (OC)
— Engineering Team (OC)
FLTCIP
— Federal Long Term Care Insurance Program
MB (CFSAN)
— Microanalytical Evaluations Branch of the Center for Food Safety and Applied Nutrition
RAC
— Raw Agricultural Commodity
AMDUCA
— Animal Medicinal Drug Use Clarification Act of 1994
LESTD (CBER)
— Laboratory of Enteric and Sexually Transmitted Diseases (CBER)
NCSES
— National Center for Science and Engineering Statistics (NSF)
CTS
— Correspondence Tracking System
DMST (CFSAN)
— Division of Market Studies (CFSAN)
RMS
— Regulatory Management System
V/V
— Verification/Validation
GDUF
— Generic Drug User Fees
RAC
— Reviewer Affairs Committee
OVST
— Operations and Veterinary Support Team
GEMCRIS
— Genetic Modification Clinical Research Information System (NIH)
DIOP (ORA)
— Division of Import Operations and Policy (ORA)
DIDP (CBER)
— Division of Information Disclosure Policy (CDER)
IDR
— Idiosyncratic Drug Reaction
DAVP (CDER)
— Division of Anti-viral Products (CDER)
RBC
— Red Blood Cells
ASCPT
— American Society for Clinical Pharmacology and Therapeutics
REMS
— Risk Evaluation and Mitigation Strategy
DSRCS (CDER)
— Division of Surveillance, Research and Communication Support (CDER)
IMDB (CDRH)
— Immunology and Molecular Diagnostics Devices Branch (CDRH)
MITA
— Medicaid Information Technology Architecture
DUSM
— Deputy United States Marshal (U.S. Department of Justice)
OIT (CFSAN)
— Office of Information Technology (Center for Food Safety and Applied Nutrition)
ORP (CFSAN)
— Office of Regulations and Policy (Center for Food Safety and Applied Nutrition)
OTR (CDER)
— Office of Testing and Research (CDER)
EVS (OC)
— Evaluation Staff (OC)
NVICP
— National Vaccine Injury Compensation Program
DFO (OC)
— Division of Field Operations (OC)
FPBR (CFSAN)
— Food Packaging Branch (Chicago, Illinois) (CFSAN)
CMCCC
— Chemistry and Manufacturing Controls Coordinating Committee
SB (ORA)
— Systems Branch (ORA)
SUPAC
— Scale-Up and Postapproval Changes
ESRA
— European Society of Regulatory Affairs
LCDC
— Laboratory Centre for Disease Control
RCHSA
— Radiation Control for Health and Safety Act of 1968
SPS
— Sanitary and PhytoSanitary
HERG
— human ether-a-go-go gene
FEDRIP
— FEDeral Research In Progress Database
OGUD (CDRH)
— Obstetrics and Gynecology Devices Branch (CDRH)
QBR
— Question-Based Review
DFLSC (CFSAN)
— Division of Food Labeling, Standards, and Compliance (CFSAN)
LRIT (CFSAN)
— Labeling Regulations Implementation Team (CFSAN)
OCM (OC)
— Office of Crisis Management (OC)
UNOS
— United Network for Organ Sharing
COTT
— Committee Of Ten Thousand
OIASI (OC)
— Office of International Activities and Strategic Initiatives (OC)
COCB (CFSAN)
— Communication and Coordination Branch (CFSAN)
RPMB (CBER)
— Regulatory Project Management Branch (CBER)
BTCB (CBER)
— Blood and Tissue Compliance Branch (CBER)
PICNIC
— Professionals and Citizens Network for Integrated Care
CMMI
— Center for Medicare and Medicaid Innovation
DDES
— Division of Dairy and Egg Safety
DRC (CVM)
— Division of Residue Chemistry (CVM)
DEPI (CBER)
— Division of Ethics and Program Integrity (CBER)
DFCN (CFSAN)
— Division of Food Contact Notifications (CFSAN)
DPQR (CDER)
— Division of Product Quality Research (CDER)
DBRA (NCTR)
— Division of Biometry and Risk Assessment (NCTR)
EIS (OC)
— Ethics and Integrity Staff (OC)
CDISC
— Clinical Data Interchange Standards Committee
PSNI
— Pharmaceutical Society of Northern Ireland
CS (OC)
— Communications Staff (OC)
DMPQ (CDER)
— Division of Manufacturing and Product Quality (CDER)
DES (OC)
— Division of Engineering Services (Immediate Office of the Commissioner)
APEC
— Asia-Pacific Economic Cooperation Council
SDWA
— Safe Drinking Water Act (as amended in 1986)
TRAC
— Tolerance Reassessment Advisory Committee
CPS
— Compendium of Pharmaceuticals and Specialties
AHFS
— American Hospital Formulary Service
JIFSAN
— Joint Institute for Food Safety and Applied Nutrition
ELS
— Establishment License Supplement
FT (OC)
— Financial Team (OC)
GARR
— Grants Application Review Request
BDR
— Budget Data Request
CE MARK
— CE (Conformite Europeene or European Conformity) marking
DP (NCTR)
— Division of Planning (National Center for Toxicological Research)
NCVIA
— National Childhood Vaccine Injury Act of 1986
ABE
— Adverse Biologic Experience
OP 4 (OC)
— Operations Team 4 (OC)
ACOL
— Acceptable Carry-Over Limit
OTCOM (CDER)
— Office of Training and Communications (CDER)
ONDQA (CDER)
— Office of New Drug Quality Assessment (CDER)
CFR
— Contract Financial Requirements
OFM (OC)
— Office of Financial Management (OC)
MMAB (CFSAN)
— Microbiological Methods Application Branch of the Center for Food Safety and Applied Nutrition
SMB (OC)
— Space Management Branch (OC)
ARDB (CDRH)
— Anesthesiology and Respiratory Devices Branch (CDRH)
DIRM (CFSAN)
— Division of Information Resources Management (CFSAN)
CET (CFSAN)
— Clinical Evaluation Team (Center for Food Safety and Applied Nutrition)
NFPA
— National Food Processors Association
DPS (CDRH)
— Division of Post-marketing Surveillance (CDRH)
CVM
— Center for Veterinary Medicine (Food & Drug Administration)
GTB (CBER)
— Gene Therapies Branch (CBER)
NEEP
— National Exercise and Evaluation Program
NAION
— non-arteritic anterior ischemic optic neuropathy
MRRA (CFSAN)
— Microbial Research and Risk Assessment Staff (CFSAN)
LRA
— Local Registration Authority
VCRP
— Voluntary Cosmetic Registration Program
LF1
— Low-value Food or Food-related products, level 1 (less than $200)
DPQ (CBER)
— Division of Product Quality (CBER)
ANCOVA
— Analysis of Covariance
COFEPRIS
— Comisi�n Federal para la Protecci�n contra Riesgos Sanitarios (Federal Commission for the Protection Against Sanitary Risks) (Mexico)
OIT (CDRH)
— Office of Information Technology (Center for Devices and Radiological Health)
TEPRSSC
— Technical Electronic Product Radiation Safety Standards Committee
UNAIDS
— Joint United Nations Program on HIV/AIDS
HAZOP
— HAZard and OPerability analysis
BMBL
— Biosafety in Microbiological and Biomedical Laboratories
BDB
— Biologic Devices Branch (CBER)
GOVCC
— government travel charge card
NHF
— National Hemophilia Foundation
CBRG
— Cancer Biomarkers Research Group
COSTART
— Coding Symbols for Thesaurus of Adverse Reaction Terms
NCID
— National Center for Infectious Diseases (CDC)
NAHC
— National Advisory Health Council
AO
— Administrative Officer
HPAA
— Health Policy and Administration
DRV
— Daily Reference Value
OBA
— Office of Biotechnology Activities
MERS-TM
— Medical Event Reporting System - Transfusion Medicine
HSOC
— Homeland Security Operations Center
QSR
— Quality System Record
IDE (CDRH)
— Investigational Device Exemptions Sections (CDRH)
MUMS
— Minor Use and Minor Species Animal Health Act of 2004
SHEMS
— Safety, Health, and Environmental Management Section
GILS
— Government Information Locator Service
ADEC
— Australian Drug Evaluation Committee
STARS
— Submission Tracking and Reporting System
BHPR
— Bureau of Health Professions
NAGC
— National Association of Government Communicators
CSB (ORA)
— Customer Support Branch (Office of Regulatory Affairs)
TBSB (CBER)
— Therapeutics and Blood Safety Branch (CBER)
DMSO
— chloroform/2-propanol/dimethylsulfoxide
COOP
— Continuity of Operations Project
NSR
— Non-Significant Risk
FCRDC
— Frederick Cancer Research and Development Center
JRIES
— Joint Regional Information Exchange System
NCIPC
— National Center for Injury Prevention and Control (CDC)
DPDFS (CFSAN)
— Division of Plant and Dairy Food Safety (CFSAN)
DEIO (ORA)
— Division of Emergency and Investigational Operations (ORA)
NIDRR
— National Institute on Disability and Rehabilitation Research
FORM 1932
— Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report - Mandatory
ACUS
— Administrative Conference of the United States
SDM
— System Development Methodology
COP
— Coastal Ocean Program
NTB (CFSAN)
— Neurotoxicology Branch (CFSAN)
ABRA
— American Blood Resource Association
IVDS
— in-vitro diagnostic devices
SISCF/SIFCF
— Survey of Inmates of State and Federal Correctional Facilities
OTS (CDER)
— Office of Translational Sciences (CDER)
FOP
— Financial Operating Plan
FTCA
— Federal Trade Commission Act
FDAS
— Defense Finance and Accounting Services
ICPEMC
— International Commission for Protection against Environmental Mutagens and Carcinogens
DCMO (ORA)
— Division of Compliance Management and Operations (ORA)
CAFDAS
— Committee for the Advancement of FDA Science
FD-483
— FDA form, Written Notice of Deficiencies Found in Inspections
MPEG
— Moving Pictures Experts Group
DM (NCTR)
— Division of Microbiology (NCTR)
OMT
— Oral Mucosal Transudate
DBE (CDER)
— Division of Bioequivalence (CDER)
BCAA
— branched-chain amino acids
DSI (CDER)
— Division of Scientific Investigation (CDER)
DFRM
— Drug Facility Registration Module (FURLS)
MTOS (CFSAN)
— Muirkirk Technical Operations Staff (CFSAN)
OCTMA (CBER)
— Office of Communication, Training and Manufacturers Assistance (CBER)
COTB (CBER)
— Communication Technology Branch (CBER)
ADE
— Adverse Drug Event
ONP (CDER)
— Office of Nonprescription Products (CDER)
NINDS
— National Institute of Neurological Disorders and Stroke
MEO
— Most Efficient Organization (Navy)
LMV (CBER)
— Laboratory of Molecular Virology (CBER)
EPMS
— Employee Performance Management System
CMHS
— Center for Mental Health Services
EB (NCTR)
— Engineering Branch (NCTR)
BLST (CFSAN)
— Building and Laboratory Services Team (CFSAN)
BPCA
— Best Pharmaceuticals for Children Act of 2002
DSM
— Data Standards Manual
PP
— Pay Period
356V
— FDA form for new animal drug appication
DCEPT (CBER)
— Division of Clinical Evaluation and Pharmacology/Toxicology (CBER)
ASICS
— Application Specific Integrated Circuits
DDMAC
— Division of Drug Marketing, Advertising, and Communications
DP (CDRH)
— Division of Physics (Center for Devices and Radiological Health)
ICLAS
— International Council for Laboratory Animal Science
DUPSA (CDRH)
— Division of Device User Programs and System Analysis (CDRH)
DVRPA (CBER)
— Division of Vaccines and Related Product Applications (CBER)
ORO (ORA)
— Office of Regional Operations (ORA)
NMPF
— National Milk Producers Federation
PVDB (CDRH)
— Peripheral Vascular Devices Branch (CDRH)
DNDLC (CDER)
— Division of New Drugs and Labeling Compliance (CDER)
ADMIA (CBER)
— Associate Director for Medical and International Affairs (CBER)
ICB (CFSAN)
— Implementation and Compliance Branch (CFSAN)
BAH
— Booz-Allen & Hamilton
DLPS (CDER)
— Division of Labeling and Program Support (CDER)
ECS (OC)
— Economics Staff (OC)
DRAT (CFSAN)
— Division of Research and Applied Technology (CFSAN)
CAERS
— CFSAN (Center for Food Safety and Applied Nutrition) Adverse Event Reporting System
OES (OC)
— Office of Executive Secretariat (OC)
ORPS (OC)
— Office of Real Property Services (OC)
LRSP (CBER)
— Laboratory of Respiratory and Special Pathogens (CBER)
RUG
— Resource Utilization Group
OIP (OC)
— Office of International Programs (OC)
OPF
— Official Personnel Folder
DPPS (CFSAN)
— Division of Plant Product Safety (CFSAN)
PCBE
— President's Council on Bioethics
CSC
— Cigarette Smoke Concentrate
DRMO (CDRH)
— Division of Risk Management Operations (CDRH)
DSFM (CDRH)
— Division of Solid and Fluid Mechanics (CDRH)
CC
— Clinical Center
ITDS
— International Trade Data System
OARSA
— Office of Applied Research and Safety Assessment
DDI (CDER)
— Division of Drug Information (CDER)
C3I
— communications, command, control, and intelligence
TFM
— Tentative Final Monograph
SPA
— Special Protocol Assessment
DMPQ (CBER)
— Division of Manufacturing and Product Quality (CBER)
TPP
— Target Product Profile
UCB
— umbilical cord blood cells
EOS (CDER)
— Executive Operations Staff (CDER)
IPRMS (OC)
— International Planning and Resource Management Staff (OC)
OCIO (OC)
— Office of the Chief Information Officer (OC)
CCFL
— Codex Committee on Food Labeling
OCTGT (CBER)
— Office of Cellular, Tissue and Gene Therapies (CBER)
GCPB II (CDER)
— Good Clinical Practice Branch II (CDER)
FCIC
— Federal Consumer Information Center
DCCA (CBER)
— Division of Communication and Consumer Affairs (CBER)
DTDNFA (CVM)
— Division of Therapeutic Drugs for Non-food Animals (CVM)
RMCC
— Review Management Coordinating Committee
DAR
— Division of Animal Research
QU
— Quality Unit
SBA
— Summary Basis of Approval
RIBAÖ
— recombinant immunoblot assay (Chiron «)
DMT (CVM)
— Division of Manufacturing Technologies (CVM)
HAD
— Hospital Anxiety and Depression scale
DDOM (CBER)
— Division of Disclosure and Oversight Management (CBER)
CABP
— Community-Acquired Bacterial Pneumonia
HFEB (CDRH)
— Human Factors Engineering Branch (CDRH)
ARAB (OC)
— Accounting Reports and Analysis Branch (OC)
WTA
— WITHHOLDING TAX ALLOWANCE
OPD (OC)
— Office of Orphan Products Development (OC)
OIT (NCTR)
— Office of Information Technology (National Center for Toxicological Research)
BRMS
— Biologics Regulatory Management System
ASC
— Advertising Standards Council
TSD (OC)
— Travel Services Division (OC)
PAITS
— Pre-Approval Inspection Tracking System
FFRM
— Food Facility Registration Module (FURLS)
MIRA
— Medicare Innovation Responsiveness Act of 2003
EMEA
— European Medicines Agency (formerly European Medicines Evaluation Agency)
RMS/BLA
— Regulatory Management System for the Biologics License Application
DFPP (CFSAN)
— Division of Food Processing and Packaging (Chicago, Illinois) (CFSAN)
BSE
— bovine spongiform encephalopathy (mad cow disease)
HBOT
— Hyperbaric Oxygen Therapy
IDL
— International Date Line
NED
— NIH (National Institutes of Health) Enterprise Directory
CIB
— Clinical Investigator's Brochure
CTTB (CBER)
— Cellular and Tissue Therapy Branch (CBER)
GRP
— Good Review Practice
DEOD (CDRH)
— Dental, Ear, Nose, Throat and Ophthalmic Devices Branch (CDRH)
CBE
— Changes Being Effected
CSS (CDER)
— Controlled Substance Staff (CDER)
CSG
— Counterterrorism Security Group
OPMAD (CDRH)
— Orthopedic Physical Medicine and Anesthesiology Devices Branch (CDRH)
SIREN
— Scientific Information Retrieval and Exchange Network (CFSAN)
3500
— FDA form for voluntary reporting of adverse events
OFSDO (CFSAN)
— Office of Food Safety, Defense and Outreach (CFSAN)
ITGS (OC)
— IT Governance Staff (OC)
EOFP
— electronic Official Personnel File
DEPI
— Division of Ethics and Program Integrity
DBOP (CDER)
— Division of Biologic Oncology Products (CDER)
ORM (ORA)
— Office of Resource Management (ORA)
IPEC
— International Pharmaceutical Excipients Council
CODB (CDRH)
— Cardiovascular and Ophthalmic Devices Branch (CDRH)
DIMS (CFSAN)
— Data Information Management Staff (CFSAN)
LIB (CBER)
— Laboratory of Immunobiochemistry (CBER)
DNRD (CDER)
— Division of Nonprescription Regulation Development (CDER)
GDEA
— Generic Drug Enforcement Act of 1992
3R
— Recruitment, Relocation bonuses, and Retention allowances
CIPP
— Critical Infrastructure Protection Program
HP
— High Potency
RSGEMS (CFSAN)
— Regulations and Special Government Employees Management Staff (CFSAN)
GRDB (CDRH)
— Gastroenterology and Renal Devices Branch (CDRH)
SUD
— Sudden Unexpected Death
FSPS (ORA)
— Federal-State Program Staff (ORA)
GHDB (CDRH)
— General Hospital Devices Branch (CDRH)
ILINET
— Influenza-like Illness Surveillance Network
INAD
— Investigational New Animal Drug
NPSB (CFSAN)
— Nutritional Product Studies Branch (CFSAN)
GATT
— General Agreement of Tariffs and Trade
NBAC
— National Bioethics Advisory Commission (replaced By PCBE; Archived At GU)
DC I (CDER)
— Division of Chemistry I (CDER)
NTA
— Notice to Applicants
SOCRA
— Society of Clinical Research Associates
AT (OC)
— Acquisitions Team (OC)
DBPAP (CBER)
— Division of Bacterial, Parasitic and Allergenic Products (CBER)
C&R
— Corrections and Removals
CND (CDRH)
— Cardiovascular/Neurological Devices Branch (CDRH)
ISASS (OC)
— International Scientific Activities and Standards Staff (OC)
NSAPE
— North American Society for Pacing and Electrophysiology
COMAH
— Control Of Major Accident Hazards Regulation of 1999
SOP
— Standard Operating Procedure
LVBD (CBER)
— Laboratory of Vector-Borne Diseases (CBER)
LDV (CBER)
— Laboratory of DNA Viruses (CBER)
CFG
— Center for Functional Genomics
ONPLDS (CFSAN)
— Office of Nutritional Products, Labeling and Dietary Supplements (CFSAN)
LR (CBER)
— Laboratory of Retroviruses (CBER)
DMB (CDER)
— Division of Management and Budget (CDER)
NMI
— Non-Medicinal Ingredient
JMO
— Japanese Maintenance Organization
DBA (CBER)
— Division of Blood Applications (CBER)
IVTB (CFSAN)
— In Vitro Toxicology Branch (CFSAN)
RAC
— Recombinant-DNA Advisory Committee
DDMSS (CDER)
— Division of Data Management Services and Solutions (CDER)
ACC
— RCHSA (Radiation Control for Health and Safety Act) ACCession number
SORN
— System of Records Notices
DETTD
— Division of Emerging and Transfusion Transmitted Diseases
IAN
— International Approved Names for pharmacopoeial substances
ADER
— Adverse Drug Experience Report
OPPB
— Office of Policy Planning and Budget
ADRM (CBER)
— Associate Director for Review Management (CBER)
CDDTB (CBER)
— Career Development and Directed Training Branch (CBER)
MPCC
— Medical Policy Coordinating Committee
ADMIA
— Associate Director for Medical and International Affairs
SC (CFSAN)
— Staff College (Center for Food Safety and Applied Nutrition)
TOA
— Total Obligation Authority
NCPDP
— National Council for Prescription Drug Programs
DDM (OC)
— Division of Dockets Management (OC)
DMARDS
— disease-modifying antirheumatic drug
IVD
— In-Vitro Diagnostics
ORADSS
— Office of Regulatory Affairs Reporting, Analysis, and Decision Support System
OMP (CDER)
— Office of Medical Policy (CDER)
CAO
— Change of Appointing Office
OSO (OC)
— Office of Security Operations (OC)
ODE IV (CDER)
— Office of Drug Evaluation IV (CDER)
IDBD
— Infectious Disease Biomarker Database
FDOT (CFSAN)
— Food Defense Oversight Team (CFSAN)
OB-GYN
— Obstetrics-Gynecology
SADR
— Suspected Adverse Drug Reaction
ACTB (NCTR)
— Analytical Chemical Techniques Branch (NCTR)
FMB
— Financial Management Branch
RDB (CDRH)
— Radiological Devices Branch (CDRH)
DLAM
— Division of Laboratory Animal Medicine
DTBOP (CDER)
— Division of Therapeutic Biological Oncology Products (CDER)
HSIN
— Homeland Security Information Network
DODP (CDER)
— Division of Oncologic Drug Products (CDER)
IQA
— Institute of Quality Assurance (UK)
AIMS
— Agency Information Management System
DFM (NCTR)
— Division of Financial Management (NCTR)
CES (CFSAN)
— Consumer Education Staff (Center for Food Safety and Applied Nutrition)
DCCT (CFSAN)
— Division of Color Certification and Technology (CFSAN)
OSAS (CFSAN)
— Office of Scientific Analysis and Support (CFSAN)
CEMB (CDRH)
— Cardiac Electrophysiology and Monitoring Devices Branch (CDRH)
ARL (ORA)
— Arkansas Regional Laboratory (ORA)
CEN
— Comite Europeen de Normalisation (European Committee for Standardization)
RIS (CBER)
— Retroviral Immunology Section (CBER)
OSE (CDER)
— Office of Surveillance and Epidemiology (CDER)
CDUS
— Clinical Data Update System (NCI)
NDMS (CDER)
— New Drug Microbiology Staff (CDER)
ATPA
— American Technology Pre-eminence Act of 1991
PPT
— Plasma Preparation Tube
NASS
— National Agricultural Statistics Service
NPCR
— National Program of Cancer Registries
CM
— Case Management
BER
— Blood Establishment Registration and Product Listing
HFES
— Human Factors and Ergonomics Society's
DPA I
— Division of Pre-marketing Assessment I
ASB (OC)
— Accounting Services Branch (OC)
PARN
— Problem/Action Request Notice
S/C
— Servings per Container
IAST (CFSAN)
— International Activities Staff (CFSAN)
OEP (CDER)
— Office of Executive Programs (CDER)
LPET (CFSAN)
— Laboratory Proficiency and Evaluation Team (CFSAN)
FPB (CFSAN)
— Field Programs Branch (Center for Food Safety and Applied Nutrition)
NPRM
— Notice of Proposed Rulemaking
COCB
— Communication and Coordination Branch
GSDB (CDRH)
— General Surgery Devices Branch (CDRH)
SBREFA
— Small Business Regulatory Enforcement Fairness Act
IMB (CDER)
— Interface Management Branch (CDER)
IMB
— Irish Medicines Board
CPI
— Critical Path Institute
OFAS (CFSAN)
— Office of Food Additive Safety (CFSAN)
OODP (CDER)
— Office of Oncology Drug Products (CDER)
DGRND (CDRH)
— Division of General, Restorative and Neurological Devices (CDRH)
PDQ
— physician data query information from national cancer institute
R&E
— Recall and Emergency
ONADE (CVM)
— Office of New Animal Drug Evaluation (CVM)
CDCP
— Centers for Disease Control and Prevention
SMPS (CDRH)
— Standards Management Program Staff (CDRH)
DGRT (NCTR)
— Division of Genetic and Reproductive Toxicology (NCTR)
CCHIT
— Certification Commission for Healthcare Information Technology
GTIS
— Gene Therapy Information System
ITATMT (OC)
— IT Asset Tracking and Management Team (OC)
FIC
— John E. Fogarty International Center
ITTT
— Information Technology Training Team
EORTC
— European Organisation for Research and Treatment of Cancer
ADR
— Adverse Drug Report
CEB (CDER)
— Clinical Evaluation Branch (CBER)
ISB (CDRH)
— Inspection Support Branch (CDRH)
VRBPAC
— Vaccines and Related Biological Products Advisory Committee
CSREES
— Cooperative State Research, Education, and Extension Services
LRN
— Laboratory Response Network
DER
— Drug Experience Report
DHFS (CVM)
— Division of Human Food Safety (CVM)
MUMS (CVM)
— Office of Minor Use and Minor Species (CVM)
CC/RVDF
— Codex Committee on Residues of Veterinary Drugs in Foods
WL
— Warning Letter (most serious Food & Drug Administration postaudit letter; demands immediate action within 15 days)
IREAS (CDRH)
— International Relations and External Affairs Staff (CDRH)
ULDB (CDRH)
— Urology and Lithotripsy Devices Branch (CDRH)
FASA
— Federal Acquisition Streamlining Act (of 1994)
FHB
— Food and Health Bureau
ALFB (CBER)
— Acess Litigation and FOI Branch (CBER)
DRM (OC)
— Division of Resource Management (OC)
DPEPOS (CFSAN)
— Division of Programs and Enforcement Policy (OS) (CFSAN)
WRAMC
— Walter Reed Army Medical Center
OND
— Office of New Drugs
MPAB (OC)
— Management Programs and Analysis Branch (OC)
GRAS/E
— Generally Recognized As Safe and Effective
NFSS
— National Food Safety System
OMB (NCTR)
— Operations and Maintenance Branch (NCTR)
OP 1
— Operations Team 1
DCIA
— Debt Collection Act of 1996
DD
— Division Director
DIO (OC)
— Division of Infrastructure Operations (OC)
MOC
— Management and Operations Council
CEDR
— Comprehensive Epidemiologic Data Resource (U.S. Department of Energy)
PNC
— Prior Notice Center
MHSB (CFSAN)
— Microbial Hazards Science Branch (CFSAN)
EPD (CDRH)
— Electronic Product Devices Branch (CDRH)
RIAS
— Regulatory Impact Analysis Statement
HDC
— High-Dose Chemotherapy
ASIA
— American Sheep Industry Association
LRPDB (CDRH)
— Labeling Research and Policy Development Branch (CDRH)
DB V (CDER)
— Division of Biometrics V (CDER)
PEP
— Performance Evaluation Plan
DTNPS (CFSAN)
— Division of Toxicology and Nutrition Product Studies (CFSAN)
LCH (CBER)
— Laboratory of Cellular Hematology (CBER)
APA
— Administrative Procedures Act
IMB (CDRH)
— Information Management Branch (CDRH)
EBPDR
— electronic biological product deviation reporting
DFPG (CFSAN)
— Division of Field Programs and Guidance (CFSAN)
NHIC
— National Health Information Center
AOFC
— Affirmation of Compliance
HCPCS
— HCFA (Health Care Financing Administration) Common Procedure Coding System
DDI
— Division of Drug Information
FRP
— Federal Response Plan (FEMA)
UADE
— Unanticipated Adverse Device Event
IOM
— Investigation Operations Manual
OCTEC (CDER)
— Office of Counter-terrorism and Emergency Coordination (CDER)
EREA
— Export Reform and Enhancement Act of 1996
BMS
— Broadcast Media Staff
IIMB (CDRH)
— IT Infrastructure Management Branch (CDRH)
ONLDS (CFSAN)
— Office of Nutrition, Labeling and Dietary Supplements (CFSAN)
AVEG
— AIDS Vaccine Evaluation Group
MDII
— Medical Device Innovation Initiative
RR
— repeatedly reactive
BSA
— Broad-Spectrum Antibiotic
DIAM
— Division of Imaging and Applied Mathematics
OSDB (CDRH)
— Orthopedic Spine Devices Branch (CDRH)
OPDFB (CFSAN)
— Office of Plants, Dairy Foods and Beverages (CFSAN)
FIS
— Field Information System
ORPSS (CFSAN)
— Office of Regulations, Policy and Social Sciences (CFSAN)
OGD (CDER)
— Office of Generic Drugs (CDER)
DPDFS
— Division of Plant and Dairy Food Safety
NSV-DO (ORA)
— Nashville (Tennessee) District Office (ORA)
TIND
— Treatment Investigational New Drug
MEFA
— Foreningen Af MEdicinfabrikanter
ITACS
— Import Trade Auxiliary Communication System
ACWA
— Administrative Careers With America
CARTS
— CFSAN (Center for Food Safety and Applied Nutrtition) Automated Research Tracking System
OPT (OC)
— Office of Pediatric Therapeutics (OC)
SMS
— Standards Management Staff (CDRH)
CCOP
— Community Clinical Oncology Program
MVT (CFSAN)
— Molecular Virology Team (CFSAN)
CDP
— Career Development Plan
ADSA
— Aging and Disability Services Administration
DMA (CDER)
— Division of Monoclonal Antibodies (CDER)
FLQ
— Fluoroquinolone
DB III (CDER)
— Division of Biometrics III (CDER)
DPIC (CFSAN)
— Division of Pesticides and Industrial Chemicals (CFSAN)
FEGLI
— Federal Employees Group Life Insurance
FMLA
— Family and Medical Leave Act of 1993
CDRS (CFSAN)
— Case Development and Recall Staff (CFSAN)
DVH
— Division of Viral Hepatitis (CDC)
MDCN
— Medicare Data Communication Network
IDIQ
— indefinite-delivery, indefinite-quantity [contracts]
DVP (CBER)
— Division of Viral Products (CBER)
IBB (CFSAN)
— Instrumentation and Biophysics Branch (CFSAN)
NONS
— Notification of New Substance Regulations 193 (EC)
SNRI
— Serotonin-Norepinephrine Reuptake Inhibitor
CST (CFSAN)
— Consumer Studies Team (CFSAN)
CGS (ORA)
— Contract and Grants Staff (ORA)
ARDB
— Anesthesiology and Respiratory Devices Branch
DFARS
— Drug Firm Annual Registration Status
FPET (CFSAN)
— Food Processing Evaluation Team (CFSAN)
EHSB
— Environmental Health Services Branch
BT
— Bacillus thuringiensis Berliner
DRUP (CDER)
— Division of Reproductive and Urologic Products (CDER)
APSB (OC)
— Accounting Policy and Systems Branch (OC)
CIQI
— Clinical Investigator Qualification Information
AMA
— Agricultural Marketing Act of 1946
WAG
— Widely Attended Gathering
SIMT
— Scientific, Internet/Intranet and Middle Tier (CFSAN)
LMD (CBER)
— Laboratory of Method Development (CBER)
MMSB (CFSAN)
— Molecular Methods and Subtyping Branch (CFSAN)
QTV
— Qualified Through Verification
GLPBB (CDER)
— Good Laboratory Practices and Bioequivalence Investigations Branch (CDER)
SSB (CDRH)
— Systems Support Branch (CDRH)
PDS (CDER)
— Project Development Staff (CDER)
NAA
— National Aquaculture Association
EES
— Establishment Evaluation System
DRP II (CDER)
— Division of Regulatory Policy II (CDER)
CERTS
— Centers for Education and Research on Therapeutics (DHHS)
OIT (CVM)
— Office of Information Technology (Center for Veterinary Medicine)
NRCC
— National Response Coordination Center
ELINCS
— European List of Notified Chemical Substances
LECC
— Law Enforcement Coordination Committee
DBGNR (CFSAN)
— Division of Biotechnology and GRAS Notice Review (CFSAN)
EB (CDRH)
— Epidemiology Branch (CDRH)
GCPP (OC)
— Good Clinical Practice Program (OC)
CCST
— Clinical Chemistry Support Team
FDAAA
— Food and Drug Administration Amendments Act
CBSC
— Cord Blood Stem Cells
OD (CDER)
— Office of the Center Director (CDER)
LBVB
— Laboratory of Biochemistry and Vascular Biology
DSDB (CDRH)
— Diagnostic and Surgical Devices Branch (CDRH)
FD-1932A
— FDA form for veterinary adverse drug reaction, lack of effectiveness, product defect report - voluntary
EEPS
— Electronic Entry Processing System
DCP 3 (CDER)
— Division of Clinical Pharmacology 3 (CDER)
QOS
— Quality Overall Summary
MACPAC
— Medicaid and CHIP Payment and Access Commission
SBIR
— Small Business Initiated Research
FCLAA
— Federal Cigarette Labeling and Advertising Act of 1965
HPO
— High Performance Organization
CPDF
— Central Personnel Data File (OPM)
BUF-DO (ORA)
— Buffalo (New York) District Office (ORA)
DFPST (CFSAN)
— Division of Food Processing Science and Technology (CFSAN)
DARPA
— Defense Advanced Research Projects Agency (DoD)
LST
— LiSTing number of a device
PMF
— Public Master File
LH (CBER)
— Laboratory of Hemostasis (CBER)
EOS (ORA)
— Executive Operations Staff (ORA)
VEDB (CDRH)
— Vitreal and Extraocular Devices Branch (CDRH)
AMB (CDRH)
— Adminstrative Management Branch (CDRH)
DB IV (CDER)
— Division of Biometrics IV (CDER)
DMQRP (CDRH)
— Division of Mammography Quality and Radiation Programs (CDRH)
CTTI
— Clinical Trials Transformation Initiative
LMDQC (CBER)
— Laboratory of Methods Development and Quality Control (CBER)
DDB (CDRH)
— Diagnostic Devices Branch (Center for Devices and Radiological Health)
NOAA
— National Oceanographic and Atmospheric Administration (U.S.)
ITSO
— Information Technology Services Officer
CRIX
— Clinical Research Information Exchange
DAIDS
— Division of AIDS (NIAID)
OCOD
— Office of Communication Outreach and Development (CBER)
FPA
— Food Products Association
RESNA
— Rehabilitation Engineering and Assistive Technology Society of North America
DVPS (CVM)
— Division of Veterinary Product Safety
NMQAAC
— National Mammography Quality Assurance Advisory Committee
DMS (OC)
— Division of Management Systems (OC)
RMS (CDER)
— Review Management Staff (CDER)
DCSC (OC)
— Division of Construction and Service Contracts (OC)
BTR
— Blood and Tissue Registration System
OSB (CFSAN)
— Office Services Branch (CFSAN)
HLGT
— high level group term
FORM 483
— Written Notice Of Deficiencies Found In Inspections
RSB (CDER)
— Review Support Branch (CDER)
NRTE
— Not Ready-To-Eat
AS (CVM)
— Administrative Staff (CVM)
LATS
— License Application Tracking System
ATPM
— Association of Teachers and Preventive Medicine
ICB (CDRH)
— Inspection and Compliance Branch (CDRH)
OPA (OC)
— Office of Public Affairs (OC)
HISPC
— Health Information Security and Privacy Collaboration
RPS (CDER)
— Regulatory Policy Staff (CDER)
DCC (OC)
— Division of Customer Care (OC)
FQHC
— Federally-Qualified Health Center
MSS (CDRH)
— Management Support Staff (Center for Devices and Radiological Health)
TERMIS
— Tissue Engineering and Regenerative Medicine International Society
OIASI
— Office of International Activities and Strategic Initiatives
CI
— Clinical Investigator
DETTD (CBER)
— Division of Emerging and Transfusion Transmitted Diseases (CBER)
RFPT (CFSAN)
— Retail Food Protection Team (CFSAN)
LHV (CBER)
— Laboratory of Hepatitis Viruses (CBER)
MMDB (CFSAN)
— Microbial Methods Development Branch (CFSAN)
BST
— Bovine Somatotropin
VISB (OC)
— Visual Information Services Branch (OC)
BISTI
— Biomedical Information Science and Technology Initiative
CFBR
— Center for Biologics Research
DCP 2 (CDER)
— Division of Clinical Pharmacology 2 (CDER)
CENELEC
— Comite Europeen de Normalisation Electrotechnique (European Committee for Electrotechnical Standardization)
DVR
— Deviation Variance Report
DC III (CDER)
— Division of Chemistry III (CDER)
CCPR
— Codex Committee on Pesticide Residues
FHSA
— Federal Hazardous Substances Act (Consumer Product Safety Commission)
CTB (CBER)
— Cell Therapies Branch (CBER)
ONCHIT
— Office of the National Coordinator for Health Information Technology
APBI
— Association of the British Pharmaceutical Industry
FORM 1932A
— Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report - Voluntary
NPPC
— National Pork Producers Council
DPC-PTR ACT
— Drug Price Competition and Patent Trade Restoration Act of 1984
DPEB
— Division of Planning, Evaluation, and Budget
DVA (CFSAN)
— Division of Virulence Assessment (CFSAN)
ITCB (OC)
— Information Technology Contracts Branch (OC)
DSMICA (CDRH)
— Division of Small Manufacturers, International and Consumer Assistance (CDRH)
MATTB (CBER)
— Manufacturers Assistance and Technical Training Branch (CBER)
REE
— Research, Education, and Economics
MDUFMA
— Medical Device User Fee and Modernization Act of 2002
ICSR
— Individual Case Safety Report
OS (CFSAN)
— Office of Seafood (CFSAN)
RIC
— Resident in Charge
DMAT
— Division of Manufacturers Assistance and Training
ALL
— Adult Acute Lymphocytic Leukemia
GADPTRA
— Generlc Animal Drug and Patent Term Restoration Act
CGMPR
— Current Good Manufacturing Practices Regulations
AFAB
— Absorbable Fibrin Adhesive Bandage
NTL
— National Testing Laboratory
SAD
— Single Ascending Dose
MAS CELL
— manipulated autologous structural cell
NOP
— National Organic Program
DMO (CFSAN)
— Division of Management Operations (CFSAN)
ACTIS
— AIDS Clinical Trials Information Service
MMRB (CFSAN)
— Microbiological Methods Research Branch (CFSAN)
FD-2301
— FDA form, Transmittal of Periodic Reports and Promotional Material for New Animal Drugs
DSPTP (CDER)
— Division of Special Pathogen and Transplant Products (CDER)
DDRE
— Division of Drug Risk Evaluation
NNC
— National Notification Center
LCT (CFSAN)
— Labeling Compliance Team (CFSAN)
NVSS
— National Vital Statistics System
LRIS
— Lot Release Imaging System
OIA (OC)
— Office of Internal Affairs (OC)
ORO
— Office of Regional Operations
LMDCI (CBER)
— Laboratory of Mycobacterial Diseases and Cellular Immunology (CBER)
GOCO
— government-owned contractor-operated
DCP (NCTR)
— Division of Contracts and Procurement (NCTR)
CCOHTA
— Canadian Coordinating Office for Health Technology Assessment
DMAT (CBER)
— Division of Manufacturers Assistance and Training (CBER)
RFCPCS (CFAN)
— Retail Food and Cooperative Programs Coordination Staff (CFSAN)
NHRIC
— national health related items code (CDRH)
AF
— Administrative File
DPA II (CDER)
— Division of Pre-marketing Assessment II (CDER)
SIB (CDRH)
— Special Investigations Branch (CDRH)
OPPL
— Office of Policy, Planning, and Legislation
DSCI (OC)
— Division of Systems, Compliance and IMPAC (OC)
ORL-DO (ORA)
— ORLando District Office (Office of Regulatory Affairs)
CBRA
— California Biomedical Research Association
EDQM
— European Directorate for the Quality of Medicines
RES
— Residence
LS
— Labelling Standard
DI
— De-Ionized
ACEC
— Autism Centers of Excellence Program (NIH)
AOPC
— Agency/Organization Program Coordinator
DCTD (CDRH)
— Division of Chemistry and Toxicology Devices (CDRH)
BIMS
— Biologic IND (Investigational New Drug) Management System
ACE
— Adverse Clinical Event
CMO
— Contract Management Organization
RSMB (CDRH)
— Reporting Systems Monitoring Branch (CDRH)
DRGUD
— Division of Reproductive, Gastrorenal and Urology Devices (CDRH)
GRN
— Generally Recognized as Safe Notification
BIRA
— British Institute of Regulatory Affairs
DDPS
— Detailed Description of the Pharmacovigilance System
DRUP
— Division of Reproductive and Urologic Products
ASD(HD)
— Assistant Secretary of Defense for Homeland Defense
LBP (CBER)
— Laboratory of Bacterial Polysaccharides (CBER)
NSRT
— Nutrition Science Review Team
HQO
— Home Quarantine Order
NCWM
— National Conference on Weights and Measures
BRB
— Biometric Research Branch
DRM (CDER)
— Division of Records Management (CDER)
DBM (CDRH)
— Division of Bioresearch Monitoring (CDRH)
DGP (CDER)
— Division of Gastroenterology Products (CDER)
FAAN
— Food Allergy and Anaphylaxis Network
OCP (CDER)
— Office of Clinical Pharmacology (CDER)
FTIM
— first time in man
JMPR
— Joint FAO-WHO Meeting of Pesticide Residues
FRDTS
— Federal Register Document Tracking System
OSEL (CDRH)
— Office of Science and Engineering Laboratories (CDRH)
SRS (CDER)
— Science and Research Staff (CDER)
CM
— Committee Meeting
MFC
— Model Food Code
EOP2
— End-Of-Phase 2
AIIS
— Analogous Industrial Injuries Scheme
R&W
— Recreation and Welfare
DCMS (CDRH)
— Division of Chemistry and Material Science (CDRH)
FMB (CDRH)
— Financial Management Branch (CDRH)
DPHB (CFSAN)
— Division of Public Health and Biostatistics (CFSAN)
DIO (CBER)
— Division of Information Operations (CBER)
HCTERS
— Human Cell and Tissue Establishment Registration System
UCUM
— Unified Codes for Units of Measure (Regenstrief Institute)
LMS
— LABORATORY MANAGEMENT SYSTEM
DID (CBER)
— Division of Information Development (CBER)
AB
— Analysis Branch
SECT 406B
— FDA Modernization Act section dealing with getting feedback from stakeholders
BPB (CBER)
— Blood and Plasma Branch (CBER)
FHA
— Federal Health Architecture
BDLS
— Blood Donor Locator Service
NBDRC
— National Blood Data Resource Center
DPAF
— Division of Planning, Analysis, and Finance
DMB (CFSAN)
— Division of Molecular Biology (CFSAN)
EMBS
— Engineering in Medicine and Biology Society (IEEE)
ACT
— Applied Clinical Trials
SCRAG
— Senior Civilian Representative of the Attorney General, Department of Homeland Security
NOOH
— Notice Offering an Opportunity for a Hearing
SDE
— State Designated Entity
SEND
— Standards for Exchange of Nonclinical Data
IRS (OC)
— International Relations Staff (OC)
RDI
— Reference Daily Intake
FLSS (CFSAN)
— Food Labeling and Standards Staff (CFSAN)
VDB (CDRH)
— Virology Devices Branch (CDRH)
KMT (OC)
— Knowledge Management Staff (OC)
FEDROOMS
— Federal Premier Lodging Program
MSAB (CFSAN)
— Manufacturing and Storage Adulteration Branch (CFSAN)
CSPDB
— Circulatory Support and Prosthetic Devices Branch
CFOI
— Census of Fatal Occupational Injuries
CFO (OC)
— Chief Financial Officer (OC)
BDPA
— Bureau of Drug Policy and Administration (China)
CCFICS
— Codex Committee on Food Import and Export Certification and Inspection Systems
HAI
— Health Action International
SR
— Sustained-Release
DBT (NCTR)
— Division of Biochemical Toxicology (NCTR)
CDP
— Candidate Development Program
NHIS
— National Institute of Hygienic Sciences
NCAB
— National Cancer Advisory Board
RPB (CDRH)
— Radiation Programs Branch (CDRH)
DCP (ORA)
— Division of Compliance Policy (ORA)
MARCS
— Mission Accomplishment and Regulatory Compliance Services System (ORA)
OTRR (CBER)
— Office of Therapeutics Research and Review (CBER)
EHPAS (NCTR)
— Environmental Health and Program Assurance Staff (NCTR)
CST
— Consumer Safety Technician
IPCB (CDER)
— Investigations and Preapproval Compliance Branch (CDER)
DESE
— Division of Electrical and Software Engineering
ORPSS
— Office of Regulations, Policy, and Social Sciences
SPGC
— Standards and Practice Guidelines Committee
TE
— Therapeutic Equivalence
SITP 5A8(OC)
— Strategic IT Programs (OC)
FPIF
— Finnish Pharmaceutical Industry Association
PMB
— Program Management Board
WEDA
— Workforce Equity and Diversity Action
DHT (CBER)
— Division of Human Tissues (CBER)
NIDR
— National Institute of Dental Research (see NIDCR)
ITC
— International Trade Commission
CSI
— Consumer Safety Inspector
WEDI
— Workgroup for Electronic Data Interchange
CERCLIS
— Comprehensive Environmental Response, Compensation and Liability Information System (EPA)
ANOC
— Annual Notice of Changes
DCP 5 (CDER)
— Division of Clinical Pharmacology 5 (CDER)
HITSP
— Health Information Technology Standards Panel
SGO
— Surgeon General's Office
DRARD
— Division of Reproductive Abdominal and Radiological Devices
NMR
— nuclear magnetic resonance spectroscopy
FSIS
— Food Safety and Inspection Service
BMIS
— Bioresearch Monitoring Information System
ADRA
— Administrative Dispute Resolution Act
DBEPA (CBER)
— Division of Blood Establishment and Product Applications (CBER)
MPQA
— Medical Products Quality Assurance
DOE B (CDRH)
— Division of Enforcement B (CDRH)
PTCC
— Pharmacology and Toxicology Coordinating Committee
PARS (CDER)
— Program Activities Review Staff (CDER)
DPEM
— Division of Planning, Evaluation, and Management
USP-NF
— United States Pharmacopeia-National Formulary
EPIA
— Egg Products Inspection Act
LPT (CFSAN)
— Liaison and Policy Team (CFSAN)
ESS (CBER)
— Executive Secretariat Team (CBER)
CSAT
— Center for Substance Abuse Treatment (SAMHSA)
ACB
— Accreditation and Certification Branch
SDWIS
— Safe Drinking Water Information System
MEDSA
— Medicine Equity and Drug Safety Act of 2000
FPLP
— Federal Premier Lodging Program
BSB (CFSAN)
— Biotechnology Studies Branch (Chicago, Illinois) (CFSAN)
IRPB
— International Research and Programs Branch
DMD (CDRH)
— Division of Microbiology Devices (CDRH)
MGB (CFSAN)
— Molecular Genetics Branch (CFSAN)
OPFIT (NCTR)
— Office of Planning, Finance and Information Technology (NCTR)
CPSA
— Consumer Product Safety Act
GMA
— Grocery Manufacturers Association's
OCI
— Office of Criminal Investigations (FDA)
LF2
— Low-value Food or Food-related products, level 2 (between $200 and $500)
DEPI (CDER)
— Division of Epidemiology (CDER)
SAS
— Symptom Assessment Scale
SCRRB (ORA)
— Scientific Compliance and Regulatory Review Branch (ORA)
AMT
— Asset Management Team
LM
— Listeria monocytogenes
GWQAP
— Government Wide Quality Assurance Program
DLPS
— Division of Labeling and Program Support
PAER
— Preliminary Adverse Event Report
CONSER
— Cooperative Online Serials
NST
— National Support Team
RAM
— Reporting and Analysis Module
OPMAD
— Orthopedic Physical Medicine and Anesthesiology Devices Branch
OFACS
— Office of Facilities, Acquisitions and Central Services
RCT (CFSAN)
— Recall Team (CFSAN)
LEAA
— Law Enforcement Alliance of America
DRR (NCTR)
— Deputy Director for Research (NCTR)
EHRP
— Enterprise Human Resources and Payroll System
OSB (CDRH)
— Office of Surveillance and Biometrics (CDRH)
AMT (OC)
— Asset Management Team (OC)
CTX
— Clinical Trials Exemption
ISBT
— International Society of Blood Transfusion
ANRC
— American National Red Cross
DOT (CFSAN)
— Division of Toxicology (CFSAN)
SFLEO
— Senior Federal Law Enforcement Official
CCC
— Compliance Coordinating Committee
DCM (CDRH)
— Division of Communications Media (CDRH)
LOINC
— Logical Observation Identifier Name Code
PDLB (CDRH)
— Pacing, Defibrillator and Leads Branch (CDRH)
DSDB
— Diagnostic and Surgical Devices Branch
ADI
— Acceptable Daily Intake (National Academy of Science)
WNET
— Women's Network for Entrepreneurial Training
BOS-DO (ORA)
— Boston (Massachusetts) District Office (ORA)
DVS (CBER)
— Division of Veterinary Services (CBER)
IDC
— Information and Data Committee
IV & V
— independent verification and validation
FPVST (OC)
— Facilities Planning and Voice Services Team (OC)
ATS (CDER)
— Applied Technologies Staff (CDER)
FORM 3500
— Voluntary Reporting of Adverse Events
GPHA
— Generic Pharmaceutical Association
ECT (CFSAN)
— Economics Team (CFSAN)
DDMS
— Division of Database Management and Services
SAB
— Science Advisory Board (USEPA)
FNH
— Febrile Non-Hemolytic reaction
NADE
— New Animal Drug Evaluation
CID
— Center for Infectious Diseases
HTRB (CBER)
— Human Tissue and Reproduction Branch (CBER)
DHS
— Department of Homeland Security (U.S.)
TDDB (CDRH)
— Television Design and Development Branch (CDRH)
MT (CFSAN)
— Medical Team (CFSAN)
RKW1
— Rockwall Building I
CCRA
— Clinical Contract Research Association
IPRO
— Independent Pharmaceutical Research Organization
OFDCER (CFSAN)
— Office of Food Defense, Communication and Emergency Response (CFSAN)
OTCDHFB (CDER)
— OTC Drugs and Health Fraud Branch (CDER)
DIT (NCTR)
— Division of Information Technology (National Center for Toxicological Research)
SSRCR
— Suggested State Regulations for Control of Radiation
TIACC
— Therapeutic Inequivalence Action Coordinating Committee
WOC I
— Woodmont Office Complex I (North)
COS (CFSAN)
— Cosmetics Staff (CFSAN)
NCBDDD
— National Center on Birth Defects and Developmental Disabilities
IPPIA
— International Plasma Products Industry Association
CSPDB (CDRH)
— Circulatory Support and Prosthetic Devices Branch (CDRH)
NDAB
— National Drugs Advisory Board
BCP
— Bureau of Consumer Protection
NOAE
— no observed adverse effect
AICRC
— Association of Independent Clinical Research Contractors
DPA I (CDER)
— Division of Pre-marketing Assessment I (CDER)
DTDFA (CVM)
— Division of Therapeutic Drugs for Food Animals (CVM)
REIS
— Regional Economic Information System
NPS (CFSAN)
— Nutrition Programs Staff (CFSAN)
NTEU
— National Treasury Employees Union
TPCC
— Therapeutic Products Classification Committee
B&F
— Budget and Finance
DCP 1 (CDER)
— Division of Clinical Pharmacology 1 (CDER)
DB VI (CDER)
— Division of Biometrics VI (CDER)
ACTB
— Analytical Chemical Techniques Branch
ARNET
— Acquisition Reform Network
DNRD
— Division of Nonprescription Regulation Development
DSPB
— Data Standards Program Board
USAMRIID
— U.S. Army Medical Research Institute for Infectious Diseases
OST (CFSAN)
— Office Services Team (CFSAN)
NVPO
— National Vaccine Program Office
SUPEC
— Scale-Up and Post-Approval Changes
USPEA
— US Poultry & Egg Association
DBCP (CBER)
— Division of Blood Collection and Processing (CBER)
RMT (CFSAN)
— Regulations Management Team (CFSAN)
ASPER
— Assistant Secretary for Personnel
PHTN
— Public Health Training Network
LPB (OC)
— Leasing and Policy Branch (OC)
DBS (CDRH)
— Division of Biostatistics (CDRH)
UKCCR
— United Kingdom Coordinating Committee on Cancer Research
NCNR
— National Center for Nursing Research (NIH)
AED
— anti-epileptic drug
ORD
— Office of Research and Demonstrations
HTM
— Health Technical Memorandum
NVCJD
— New Variant Creutzfeldt-Jakob Disease
DPA II
— Division of Pre-marketing Assessment II
LVCH
— Local VouCHer
DRPM
— Dispute Resolution Project Manager
DDDP
— Division of Dermatology and Dental Products
LERN
— Library Electronic Reference Network
HLBT
— Heat Labile Bacterial Toxins
SUPAC-MR
— scale-up and postapproval changes--modified release
NCHGR
— National Center for Human Genome Research (NIH)
SID
— schedule identifier number (ORA AofC code)
EOP1
— End-Of-Phase 1
MDB (CFSAN)
— Methods Development Branch (CFSAN)
BOS-DO
— BOSton, Massachusetts, District Office
DS (CVM)
— Division of Surveillance (CVM)
EEO (NCTR)
— Equal Employment Opportunity Staff (NCTR)
DB II (CDER)
— Division of Biometrics II (CDER)
DES (CVM)
— Division of Epidemiology and Surveillance (Center for Veterinary Medicine)
OR
— Office of Research
CCID
— Coordinating Center for Infectious Diseases
NOH
— Notice Of Hearing
ADUFA
— Animal Drug User Fee Act of 2003
PTC
— Parklawn Training Center
CGCS
— computer-generated cover sheet
CUF
— Commissione Unica del Farmaco (Italy)
CTA
— Clinical Trial Application
NOA
— Notice Of Availability
BWM
— Biologics Workload Management
PAFA
— Priority-Based Assessment of Food Additives
DMS (CFSAN)
— Division of Microbiological Studies (CFSAN)
OCTMA
— Office of Communication, Training and Manufacturers Assistance
SGE
— special Government employee
DTP (CDER)
— Division of Therapeutic Proteins (CDER)
DCM (CBER)
— Division of Case Management (CBER)
BIND
— Biological Investigational New Drug
VMAC
— Veterinary Medicine Advisory Committee
DPS (CFSAN)
— Division of Program Services (CFSAN)
GPEA
— Government Paperwork Elimination Act
DEHP
— Di(2-ethylhexyl)phthalate
IPOAB
— Information Processing and Office Automation Branch
DCP 4 (CDER)
— Division of Clinical Pharmacology 4 (CDER)
MTOS
— Muirkirk Technical Operations Staff (Laurel, Maryland)
NGFA
— National Grain and Feed Association
RADAR
— Radio Detecting and Ranging
DE (CFSAN)
— Division of Enforcement (CFSAN)
CBCTN
— Community-Based Clinical Trials Network
OCPP
— Office of Critical Path Programs
IFMFS (CFSAN)
— Infant Formula and Medical Foods Staff (CFSAN)
SE
— Standard Error
PAG
— Project Advisory Group
TEP
— therapeutic exchange plasmapheresis
IB (ORA)
— International Branch (ORA)
DIS (CBER)
— Division of Inspections and Surveillance (CBER)
DCD (CDRH)
— Division of Cardiovascular Devices (CDRH)
NWK-DO (ORA)
— Newark District Office (ORA)
DMC
— Data Monitoring Committee
ADRA
— Associate Director of Regulatory Affairs
ICIB (CDRH)
— Intraocular and Corneal Implants Branch (CDRH)
EEO (CFSAN)
— Equal Employment Opportunity Office (CFSAN)
SUDS
— Single-Use Devices
INNS
— International Neural Network Society
406B
— Section of the FDA Modernization Act dealing with getting feedback from our stakeholders
CAC
— Carcinogenicity Assessment Committee
SGEMT (CFSAN)
— Special Government Employees Management Team (CFSAN)
DCC (CFSAN)
— Division of Cosmetics and Compliance (CFSAN)
MNVP
— Medically Necessary Veterinary Product
DRP I (CDER)
— Division of Regulatory Policy I (CDER)
DCP (CFSAN)
— Division of Cooperative Programs (CFSAN)
DVS (NCTR)
— Division of Veterinary Services (NCTR)
ADAM
— Analysis Dataset Model
FARM
— Food Additives Regulatory Management System
FICEMS
— Federal Interagency Committee on Emergency Medical Services
OMO (CDRH)
— Office of Management Operations (CDRH)
OIRA
— Office of Information & Regulatory Affairs
DSRIT (CFSAN)
— Dietary Supplement Regulations Implementation Team (CFSAN)
COMSTAT
— COMpliance STATus Information System
NEFLE
— National Exchange for Food Labeling Education
ASHRAE
— American Society of Heating, Refrigeration & Air Conditioning Engineers
OSS (OC)
— Office of Shared Services (OC)
AOB
— Accounting Operations Branch
BIG
— Blacks In Government
IDBR
— Infectious Disease Board Review
DEC (CFSAN)
— Division of Education and Communication (CFSAN)
FAIR
— Federal Activities Inventory Reform Act of 1998
DIS (CDER)
— Division of Information Services (CDER)
SDCID
— Study Data Common Issues Document
TBSB
— Therapeutics and Blood Safety Branch
CARES
— Cardiac Arrest Registry to Enhance Survival [CDC]
VCTB (CBER)
— Vaccine Clinical Trials Branch (CBER)
CPG
— Compliance Policy Guide
NDRMMP
— National Drug Residue Milk Monitoring Program
BACON
— Bacterial CONtamination
CDDI
— Collaboration for Drug Development Improvement
CIRS
— Center Information Retrieval System
DCGT (CBER)
— Division of Cell and Gene Therapies (CBER)
DE (CBER)
— Division of Epidemiology (CBER)
INRO
— Intramural NIAID Research Opportunities (National Institute of Allergy and Infectious Diseases)
AR
— approvable letter
NBCS
— National Biomedical Computer System
PPIA
— Poultry Products Inspection Act
EOS
— End of Study
RCS (CFSAN)
— Regulations Coordination Staff (CFSAN)
HCTRS
— Human Cell and Tissue Establishment Registration System (usually seen as HCTERS)
CSA
— Controlled Substances Act
DRISK (CDER)
— Divison of Risk Management (CDER)
PV
— Process Validation
OSCI (CFSAN)
— Office of Science (CFSAN)
DC (CVM)
— Division of Compliance (CVM)
AFC
— Adult Foster Care
MBES
— Medicaid Budget and Expenditure System
NOMI
— Federation of Norwegian Pharmaceutical Manufacturers
FLC
— Federal Laboratory Consortium
TBT
— Technical Barriers to Trade
ESS (NCTR)
— Executive Secretariat Staff (NCTR)
DB (CBER)
— Division of Biostatistics (CBER)
NARMS
— National Antimicrobial Resistance Monitoring System
DC II (CDER)
— Division of Chemistry II (CDER)
RRHR
— Regional Radiological Health Representative
OEEODEM (OC)
— Office of EEO and Diversity Management (OC)
IAVG
— Interagency Vaccine Group
NCIMS
— National Conference on Interstate Milk Shipments
CSDD
— Center for the Study of Drug Development (Tufts University)
LCP (CDER)
— Laboratory of Clinical Pharmacology (CDER)
NASAR
— National Association of Search and Rescue
HCT/P
— human cellular and tissue-based products
BEST
— Biomonitoring of Environmental Status and Trends (Biological Resources Division, USGS)
ELIPS
— Electronic Labeling Information Processing System
VBPF
— vegetative bacteria, protozoa and viruses
GCC
— Government Coordinating Council of the Food and Agriculture Sector
LD50
— Lethal Dose where 50% of the population dies
DSATOS (CFSAN)
— Division of Science and Applied Technology (OS) (CFSAN)
UDI
— Unique Device Identification
ECRS (CFSAN)
— Emergency Coordination and Response Staff (CFSAN)
DRAT
— Division of Research and Applied Technology
SQA
— Society of Quality Assurance
WLF
— Washington Legal Foundation
DLS
— Document Logging System
WNV
— West Nile Virus
SRMS
— Specified Risk Materials
DTS
— Distribution Tracking System
USOPM
— United States Office of Personnel Management
DBC (CFSAN)
— Division of Bioanalytical Chemistry (CFSAN)
FORCG
— Foodborne Outbreak Response Coordinating Group
SRAS
— Secure Remote Access Service
ORS (CFSAN)
— Office of Regulatory Science (CFSAN)
BAC
— Billing Agency Code
CADSR
— Cancer Data Standards Repository
DB I (CDER)
— Division of Biometrics I (CDER)
MERCOSUR
— MERcado COmún del SUR (Southern Common Market)
AMA-DE
— American Medical Association Drug Evaluation
ABLES
— Adult Blood Level Epidemiology & Surveillance
NTF
— National Turkey Federation
CERG
— CBER Emergency Relocation Group
RFDD
— Regional Food and Drug Director
ERIC
— Employee Resource Information Center
TSSS (CDER)
— Technology Support Services Staff (CDER)
EUCOMED
— EUropean COnfederation of MEDical Devices Associations
PDUFA
— Prescription Drug User Fee Act of 1992
AE
— Approvable, but not yet approved
CABE
— corrective action(s) being effected
LRS
— Lot Release System
DPS (CBER)
— Division of Program Services (CBER)
CHII
— Consolidated Health Informatics Initiative
SCAW
— Scientists Center for Animal Welfare
OGC
— Office of the General Counsel (DHHS)
CABS
— Conformity Assessment Bodies
NIAMS
— National Institute of Arthritis and Musculoskeletal and Skin Diseases
CHI
— Consolidated Health Initiative
TVBB (CBER)
— Tumor Vaccines and Biotechnology Branch (CBER)
FEDGLOBE
— Gay, Lesbian, Bisexual, Transgender Employees of the Federal Government
ONDCP
— Office Of National Drug Control Policy
LSHLC
— Lipid-Soluble Heat-Labile Chemical
GPRA
— Government Performance Results Act of 1993
PSSB
— Program Support Services Branch
BEQ
— bioequivalence
NOV
— Notice Of Violation letter
IFAD
— International Food Additives Database
OVI
— Organic Volatile Impurity
DPR (CFSAN)
— Division of Petition Review (CFSAN)
ECRI
— Emergency Care Research Institute (no longer uses name initials only)
USAN
— United States Adopted Name
CSAP
— Center for Substance Abuse Prevention (SAMHSA)
FWP
— Federal Women's Program
OCO (CFSAN)
— Office of Constituent Operations (CFSAN)
HTLV-III
— human lymphotropic virus, type III (AIDS agent, HIV)
MMDB
— Microbial Methods Development Branch
CUVP
— Committee for Veterinary Medicinal Products (EMEA)
DC (NCTR)
— Division of Chemistry (NCTR)
TBP
— Therapeutic Biologic Product
TPDS
— Training and Professional Development Staff
ERSB (CFSAN)
— Emergency Response and Surveillance Branch (CFSAN)
DEEM
— Dietary Exposure Evaluation Model (Durango Software LLC)
BOP
— Boards Of Pharmacy
NIDPOE
— Notice of Initiation of Disqualification Proceeding and Opportunity to Explain
INDE
— Investigational New Drug Exemption
ESB
— Enterprise Systems Branch
VOAD
— Volunteer Organizations Active in a Disaster
LR2
— Low-value non-prescription Radiation-emitting products, level 2 (between $200 and $1000)
AHI
— Animal Health Institute
LIR (CBER)
— Laboratory of Immunoregulation (CBER)
CCEHRP
— Committee to Coordinate Environmental Health and Related Programs (PHS)
DRA (CFSAN)
— Division of Risk Assessment (CFSAN)
CASPER
— Center Automated System Process Exchange and Reporting
LPD (CBER)
— Laboratory of Plasma Derivatives (CBER)
CSA
— Clinical Study Agreement
DH (CBER)
— Division of Hematology (CBER)
OHSC
— OCCUPATIONAL HEALTH and SAFETY CENTRE
RTL (NCTR)
— Reproductive Toxicology Laboratory (NCTR)
DQRS
— Drug Quality Reporting System
CARS
— Compliance Achievement Reporting System
ART
— Assisted Reproductive Therapy
HDE
— Humanitarian Use Exemption
NCPHI
— National Center for Public Health Informatics (CDC)
FPBR
— Food Packaging Branch (Chicago, Illinois)
MRE
— Meal, Ready-To-Eat
NAD
— NED Animal Drug number
SAT (CFSAN)
— Statistical Applications Team (CFSAN)
NCER
— Non-Conformance Escalation Report
FDAGLOBE
— Gay, Lesbian, Bisexual, Transgender Employees of the Federal Government within FDA
OEXA
— Office of External Affairs (OC)
INDC
— Investigational New Drug Committee
CDTL
— Cross Discipline Team Leader
[NA]TAG
— [North American] Technical Advisory Group
HSBT
— Heat Stable Bacterial Toxins
SAP
— Scientific Advisory Panel (SARCS)
MEDSUN
— Medical Product Safety Network
DB (CDRH)
— Division of Biology (CDRH)
EDRG
— Early Detection Research Group
NCVHS
— National Committee on Vital and Health Statistics
COS
— cosmetic registration number (ORA AofC code)
SSA
— Sector-Specific Agencies
RRS
— Resource Reporting System
NLN
— Nordiska LäkemedelsNämnden (Nordic Council on Medicines)
SISTIR
— Strategic Information Systems Technical Integration Resources
LRB (CDER)
— Labeling Review Branch (CDER)
CS (CVM)
— Communications Staff (CVM)
IPU
— Irish Pharmaceutical Union
DCM
— Division of Case Management
BACPAC
— Bulk ACtivities Post-Approval Changes
HRRC
— Human Research Review Committee
IFIP
— International Federation For Information Processing
FES (OC)
— Financial Enterprise Solutions (OC)
LRP
— Low Regulatory Priority
SSCT
— Swedish Society for Clinical Trials
BPB
— Blood and Plasma Branch
VATS
— Viral Activation Transfusion Study
UNII
— Unique Ingredient Identifier
DEP
— Data Evaluation Project
OMP (OC)
— Office of Management Programs (OC)
SMT (CFSAN)
— Statistical Methodology Team (CFSAN)
SOC
— System Organ Classes
VSS (NCTR)
— Veterinary Services Staff (NCTR)
MSTD
— Materials Science and Technology Department
AUA
— Agency for Healthcare Research and Quality
NCFST
— National Center for Food Safety & Technology
EPRS
— Establishment Product Registration System
AGA
— Association of Government Accounts
IIFAR
— Incurably Ill for Animal Research
RR
— Relative Risk Estimates
BLST
— Building and Laboratory Services Team
EIDE
— Electronic Investigational Device Exemption
QSR
— Quality System Representative
PAAB
— Pharmaceutical Advertising Advisory Board (Canada)
ACS
— Automated Commercial System
FGIS
— Comisión Federal para la Protección contra Riesgos Sanitarios (Federal Commission for the Protection Against Sanitary Risks) (Mexico)
DCT (CDER)
— Division of Counter-terrorism (CDER)
SAI
— Single Active Ingredient
NCMHD
— National Center on Minority Health and Health Disparities (NIH)
FPB
— Food Processing Branch (Chicago, Illinois)
SDTM
— Study Data Tabulation Model
SLK
— Statens Legemiddel Kontroll (Norwegian Medicines Control Authorities)
RDTS
— Reproductive and Developmental Toxicology Subcommittee (CDER)
SMS (CFSAN)
— Safety Management Staff (CFSAN)
CALA
— computer-assisted license application
BAER
— Brief Adverse Event Report
HARTS
— Hoechst Adverse Reaction Terminology System
AIP
— APHIS (Animal and Plant Health Inspection Service) Integrated Planning
SHIE
— State Health Information Exchange
IDF
— Immune Deficiency Foundation
STB (ORA)
— State Training Branch (ORA)
DDA
— Division of Drug Analysis
NDAC
— Nonprescription Drug Advisory Committee
DM (CFSAN)
— Division of Microbiology (CFSAN)
LASIK
— Laser ASisted In-situ Keratomileusis
DDOM
— Division of Disclosure and Oversight Management
DME (NCTR)
— Division of Molecular Epidemiology (NCTR)
SUPEC-IR
— Scale-Up and Post-Approval Changes - Instant Release
MHPF
— Minority Health Professionals Foundation
PDMA
— Prescription Drug Marketing Act of 1988
PELT
— Product Evaluation and Labeling Team
DDM
— Division of Dockets Management
OFFAS (OC)
— Office of Field Financial and Acquisitions Services (OC)
FPVST
— Facilities Planning and Voice Services Team
SPS (CFSAN)
— Science and Policy Staff (CFSAN)
NREVSS
— National Respiratory and Enteric Virus Surveillance System
BRMAC
— Biological Response Modifiers Advisory Committee
VCH
— Travel VouCHer claim
JIFSAN (CFSAN)
— JIFSAN Liaison Staff (CFSAN)
LPRVD (CBER)
— Laboratory of Pediatric and Respiratory Viral Diseases (CBER)
IQMP
— Integrated Quality Management Plan
DMS (CDER)
— Division of Management Services (CDER)
AWC
— Adequate and well-controlled
FMS
— Financial Management Service (U.S. Department of the Treasury)
DPP (CDER)
— Division of Psychiatry Products (CDER)
APR
— Annual Product Review
BTCB
— Blood and Tissue Compliance Branch
DADS
— Department of Aging and Developmental Services
GRC
— Gerontology Research Center
PDE-4
— PhosphoDiEsterase-4
OPS
— Office of Pharmaceutical Science
OSE
— Office of Surveillance and Epidemiology
DM (CFSAN)
— Division of Mathematics (CFSAN)
CACTIS
— Center ADP/TC Computer Tracking and Inventory System
ECP
— Emergency Contraception Pill
NIPP
— National Infrastructure Protection Plan
BUF-DO
— BUFfalo, New York, District Office
DB
— Double-Blind
NE-FO (ORA)
— Regional Field Office, Northeast Region
CTP
— Center for Tobacco Products
NME
— New Molecular Entity
SSE
— Summary of Safety and Effectiveness
DQ
— Design Quality
QMS
— Quality Management Staffing
DEOD
— Dental, Ear, Nose, Throat, and Ophthalmic Devices Branch
NIMH
— National Institute of Mental Health (NIH)
NSE
— Not Substantially Equivalent
LBPUA (CBER)
— Laboratory of Bacterial, Parasitic and Unconventional Agents (CBER)
FEHB
— Federal Employees Health Benefits
DTBE
— Division of Tuberculosis Elimination
SCVIR
— Society for Cardiovascular and Interventional Radiologists (now SIR)
IIMG
— Interagency Incident Management Group
NSRT (CFSAN)
— Nutrition Science Review Team (CFSAN)
SACS
— Scientific Advisors and Consultants Staff
HCDB (CDRH)
— Hematology and Cytology Devices Branch (CDRH)
NRB
— Noninstitutional Review Board
SN/AEMS
— Special Nutritional Adverse Events Monitoring System
RCS
— Records Control Schedule
COPTRG
— Community Oncology and Prevention Trials Research Group (NCI)
BENS
— Business Executives For National Security
DPFRM
— Division of Planning and Financial Resources Management
EPO
— European Patent Office
WO (NCTR)
— Washington Office (NCTR)
OSCAR
— ORACLE System for Center Automation and Retrieval
DSAC
— Division of Scientific Advisors and Consultants
SSAST (CFSAN)
— Senior Science Advisor's Staff (CFSAN)
EAC
— Expert Advisory Committee (Canada)
CDR
— Central Document Room
MLTC
— Managed Long-Term Care
MFA
— Medicated Feed Application number
OSMP
— Office of Special Medical Programs
DLS
— Diagnostic Laboratory Services
ADWOH
— Average Day's Work On Hand
SPLAT
— Structured Product Labeling Advisory Team
COPR
— Council of Public Representatives (NIH OD)
TGA
— Therapeutic Goods Administration (Australia)
RAA
— Research Across America (various locations)
RVIS
— Residue Violation Information System
MSI
— Magnetic Source Imaging
REG NEG
— regulatory negotiation
SAER
— Standard Adverse Event Report Review (CDRH)
MMRB
— Microbiological Methods Research Branch
APSB
— Accounting Policy and Systems Branch
MPAB
— Management Programs and Analysis Branch
NRP-CIS
— National Response Plan Catastrophic Incident Supplement
INFARMED
— Instituto Nactional da FARMaciae e do MEDicamento (Portugal)
FEEA
— Federal Employee Assistance and Education Fund
OIA
— Office of Internal Affairs
FSA
— Farm Service Agency (USDA)
CHISSA
— Center for High Integrity Software System Assurance
DFFI
— Division of Foreign Field Investigations (ORA)
NICCL
— National Incident Communications Conference Line
LBL
— Ernest Orlando Lawrence Berkeley National Laboratory
BCE
— Beneficial Clinical Event
RIHSC
— Research Involving Human Subjects Committee (FDA)
FIFR
— first-in-first reviewed
DC
— Discharge Clinic
GRNS
— Generally Recognized as Safe Notifications
IFU
— Instructions For Use
OB
— Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)
SNIP
— Syndicat National de l'Industrie Pharmaceutique
SCGD
— Special Controls Guidance Document
DRB
— Devices Review Branch
NISAC
— National Infrastructure Simulation and Analysis Center (Department of Homeland Security)
NDMA
— Nonprescription Drug Manufacturers Association (now CHPA)
LUACRG
— Lung and Upper Aerodigestive Cancer Research Group
NEXT
— Nationwide Evaluation of X-ray Trends (CDRH)
MVB
— Molecular Virology Branch
ETA
— EASE (Enterprise Administrative Support Environment) Time and Attendance module
CRIS
— Clinical Research Information System (NIH)
PAMP
— Post-approval Monitoring System
OP 4
— Operations Team 4
DMO (ORA)
— Division of Management Operations (ORA)
ODE (CDRH)
— Office of Device Evaluation (CDRH)
CP
— Compliance Program
RIMS
— Regulatory Information Management Staff
ESB (ORA)
— Enterprise Systems Branch (ORA)
BPWG
— Business Process Working Group
ROA
— Read Only Access
MSQA
— Mammography Quality Standards Act of 1992
AMB
— Adminstrative Management Branch
EGA
— European Generics Medicines Association
IOTF
— Interagency Oncology Task Force
URAA
— Uruguay Round Agreements Act of 1994
SMART
— Submission Management and Review Tracking
ATO
— Authorization to Operate
ADAM7
— Analysis Data Model
BWM
— basic workload measurement
ITT
— Intent to Treat
TBLS
— Team Biologics Liaison Staff (CBER)
CPAC
— Central Pharmaceutical Affairs Council (Japan)
RPM
— Regulatory Project Manager
CTM
— Clinical Trials Materials
LARD
— Licensing Action Recommendation Document
DDSL
— Division Data Standards Leads
BPD
— Biological Product Deviation
CABIG
— Cancer Biomedical Informatics Grid (NIH)
BPC
— Bureau of Policy and Coordination
OMS (CFSAN)
— Office of Management Systems (CFSAN)
PST
— Porcine Somatotropin
PPV
— Patient Profile Viewer
UMCP
— University of Maryland-College Park
NDE
— New Drug Evaluation
INS
— Incident of National Significance
HIRS
— Health Information Resources Service
IMC
— Information Management Consultants, Inc.
RACC
— Reference Amount Customarily Consumed
BSC
— Blood Safety Committee
GIPSA
— Grain Inspection, Packers & Stockyards Administration (USDA)
MIWG
— Mentoring Implementation Working Group
ADRS
— Adverse Drug Reporting System
OAP
— Office of Antimicrobial Products
SSC
— Systems Steering Committee
CPFP
— Cancer Prevention Fellowship Program (NCI)
PTB
— Pharmacology and Toxicology Branch
BUS
— BIMS (Biologic IND (Investigational New Drug) Management System) User Support Group
AIN
— food additive identification number (ORA AofC code)
NHE
— National Health Expenditures
JFTR
— Joint Federal Travel Regulations
SWDB (CDRH)
— Software and Web Development Staff (CDRH)
SME
— Significant Medical Event
NEFARMA
— NEederlandse FARMAceutische Industrie (NEtherland Association of the Research-oriented PHARMAceutical Industry)
HBOC
— hemoblogin-based oxygen carrier
NCHM
— National Center for Health Marketing
NAM
— National Agency for Medicines
OFS (OC)
— Office of Financial Services (OC)
OP 2
— Operations Team 2
SACD
— Special Assistant to the Center Director
ADP (CBER)
— Associate Director for Policy (CBER)
NCRM
— National Comorbidity Survey Replication
MIG
— Medicaid Infrastructure Grant
CVMP
— Committee on Veterinary Medical Products
GCRC
— General Clinical Research Centers
JLCS (OC)
— Jefferson Laboratory Complex Staff (OC)
MCA
— Medicines Control Agency (part of MHRA)
CODB
— Cardiovascular and Ophthalmic Devices Branch
OP 3
— Operations Team 3
MIP
— Management Improvement Plan
FEHBP
— Federal Employees Health Benefits Program
ASB
— Administrative Services Branch
UMLS
— Unified Medical Language System (NLM)
GRS
— General Records Schedule
BDSS
— Biologics Decision Support System
CRWG
— Hurricane Katrina Comprehensive Review Working Group
IMDA
— Irish Medical Device Association
LACF
— Low-Acid Canned Food
S&I
— Standards and Interoperability
NVOAD
— National Volunteer Organizations Active in Disaster
DEN
— Drug Experience Network
RTL
— Reproductive Toxicology Laboratory
OPL (OC)
— Office of Planning (OC)
CTS
— counseling and testing site
DXA
— Dual-energy X-ray Absorptiometry test
SPL
— Structured Product Labeling
FAME
— Formula for Achieving Managerial Excellence
DSSC
— Dietary Supplements Subcommittee
NDIRS (CFSAN)
— New Dietary Ingredients Review Staff (CFSAN)
ISR
— Individual safety report
NEPA
— National Environmental Policy Act
INA
— Investigational New Animal drug number
CCA
— Clinger-Cohen Act (formerly the Information Technology Management Reform Act)
HIDE
— High Impact Data Elements
RDB
— Radiological Devices Branch
ADR (CBER)
— Associate Director for Research (CBER)
MCMI
— Medical Countermeasures Initiative
FACD
— Food Additives and Chemicals Division
SAF
— state access to FACTS
AI
— Additional Information (Letter)
FTR
— Federal Travel Regulations
TRANS NET
— internet-based blood shortage reporting program (FDA)
TSOPS
— temperature standard operating procedures
GEO
— Genetically Engineered Organism
BT
— Bioterrorism
PTEI
— Pittsburgh Tissue Engineering Initiative
DSRIT
— Dietary Supplement Regulations Implementation Team
NFT
— Notification of Foreign Travel
BFAC
— Biologics Field Advisory Committee (CBER)
ADP
— Associate Director for Policy
IGM
— VCA)-immunoglobin M
EAB
— Ethics Advisory Board
COOL
— country-of-origin labeling
GHS
— Globally Harmonised System of Classification and Labelling of Chemicals
ALFB
— Access Litigation and FOI (Freedom Of Information) Branch
NVTB (CFSAN)
— Neurotoxicological and In Vitro Toxicology Branch (CFSAN)
CO
— Contract Officer
CRC
— Civil Rights Center (U.S. Department of Labor)
SIA
— Strip Immunoblot Assay
NRSP
— National Research Support Project
LASA
— Linear Analog Self-Assessment measure
BLT
— Blood Logging and Tracking System
LCP
— Laboratory of Clinical Pharmacology
PTC
— Points to Consider
ITIC
— Information Technology Implementation Committee (CBER)
OVRR
— Office of Vaccines Research and Review
TSS
— Transfusion Safety Study
HPUS
— Homeopathic Pharmacopeia of the United States
DRFDD
— Deputy Regional Food and Drug Director
MHBG
— Mental Health Services Block Grant
INN
— International Non-Proprietary Name
BRAIN
— Brain Research through Advancing Innovative Neurotechnologies
TSSRC
— Toxicology Study Selection and Review Committee
ORWH
— Office Research into Women's Health (NIH)
PQAS
— Pharmaceutical Quality Assessment System
MATTB
— Manufacturers Assistance and Technical Training Branch
RSS
— RDF (Resource Data Framework) Site Summary
ESM
— Electronic Secure Messaging
SIS
— Streamlined Inspection System
RIS
— Retroviral Immunology Section
ACT
— AIDS Clinical Trials
CRS
— Contamination Response System
FPET
— Food Processing Evaluation Team
LDPE
— Low Density Poly-Ethylene
SPLIEP
— Structured Product Labeling Interagency Executive Panel
PTE
— Patent Term Extension
IEC
— Independent Ethics Committee
PAM
— Pesticide Analytical Manual
JFHQ
— Joint Force Headquarters
MEMO
— Medicines Evaluation and Monitoring Organization
DPR
— Division of Petition Review
MGSS
— Multi-Generation Support System
PB (CDRH)
— Planning Branch (CDRH)
OIVD
— Office of In-Vitro Diagnostic Device Evaluation and Safety
MACS
— Manufacturers Assistance and Communications Staff
CHID
— Combined Health Information Database (NIH)
RUP
— Restricted Use Pesticide
EVA
— Entry Validation Application
MATS
— Management Assignment Tracking System
BCB
— Bioanalytical Chemistry Branch
IFE
— Import for Export
NCP
— Non-Conforming Product
ILAR
— Institute For Laboratory Animal Research
OJDB (CDRH)
— Orthopedic Joint Devices Branch (CDRH)
TAVC
— total aerobic viable count
BOCB
— Biological and Organic Chemistry Branch
IA
— Import Administration (United States Department of Commerce)
REG
— Drug REGistration number
MDUFSA
— Medical Device User Fee Stabilization Act of 2005
DFSR
— Division of Federal-State Relations (Office of Regulatory Affairs)
SOC
— System Organ Class
LARM
— Licensing Action Recommendation Memorandum
OE (ORA)
— Office of Enforcement (ORA)
DD
— Department of Drugs (Swedish regulatory agency)
NWR
— NOAA (National Oceanic and Atmospheric Administration) Weather Radio
DPAP
— Division of Pulmonary and Allergy Products
RTAU
— Review and Technical Assistance Unit
PTFE
— Polytetrafluroethylene
BRCC
— Biologics Research Coordinating Committee
ELIST
— electronic listing system
NAF
— Notice of Adverse Findings
SCC
— Sector Coordinating Council for Food and Agriculture
TI
— Tolerable Intake
GAAP
— Greater Access to Affordable Pharmaceuticals Act of 2003
VSOF
— Visual Status of Funds
IMTS
— Industry Meeting Tracking System
ARIES
— Administrative Resources Information Exchange System
ABC
— America's Blood Centers
OCTGT
— Office of Cellular Tissue and Gene Therapies
ODSIR
— Office of Drug Security Integrity and Recalls
IRIS
— International Regulatory Issues Staff
RSVIG
— respiratory synctial virus immune globulin
LCI
— Livestock Conservation Institute
DPA
— Division of Pharmaceutical Analysis
SPOTS
— Special Products On-line Tracking System
MVT
— Molecular Virology Team
BPSRG
— Biomedical and Pharmaceutical Sciences Research Group
STS
— Standards and Testing Staff
SLIP
— serial line internet protocol/point-to-point protocol
DNT (NCTR)
— Division of Neurotoxicology (NCTR)
DTDFA
— Division of Therapeutic Drugs for Food Animals
DPRF
— Drug Product Reference File
REDS-II
— Retrovirus Epidemiology Donor Study Two
AVA
— American Veal Association
ARCH
— Administrative Resources Core Hub
COBTA
— Council On Biologics and Therapeutic Agents
DS
— Drug Substance
VHSP
— Viral Hepatitis Surveillance Program (CDC)
OMRF
— Oklahoma Medical Research Foundation
SRS
— Substance Registration System
OC
— Immediate Office of the Commissioner
ELDU
— Extra-Label Drug Use
FOIB (CDRH)
— Freedom of Information Branch (CDRH)
ARTCA
— Antimicrobial Regulations Technical Correction Act of 1998
REGO
— Reinventing the United States Government
EIEIO
— External Interference Engineering Investigations Office
DDSPC
— Division of Dietary Supplement Programs and Compliance
WEAC
— Winchester Engineering & Analytical Center
SSC
— Special search category
RDE
— Remote Data Entry
RTE
— Ready-To-Eat
TB
— Tuberculosis Basic
MDDRP
— Medical Device Dispute Resolution Panel
HSUS
— Humane Society of the United States
SITP(OC)
— Strategic IT Programs (OC)
VETTRADE
— Veterinarian Trading Post (website)
RRS16A0S
— Regulatory Review Support Staff
CRR
— Consult Review Request
AME
— Absorption Metabolism Excretion
HAA
— Hepatitis-Associated Antigen
ADR
— Associate Director for Research
PMPRB
— Patented Medicine Prices Review Board
OSS
— Office of Shared Services
LS (CDRH)
— Library Staff (CDRH)
IGA
— Immunoglobin A
PAT
— Process Analytical Technology Initiative
NAT
— Nucleic Acid-based Tests
IHSP
— influenza Hospitalization Surveillance Project
OCTEC
— Office of Counter-Terrorism and Emergency Coordination
ICAM
— International Cooperative Agreements Manual
MDL
— MoDeL number
ICCR
— International Cooperation on Cosmetics Regulation
OPL
— Office of PLanning
CA
— Committee Assignment
ULDB
— Urology and Lithotripsy Devices Branch
ISIS
— import support and information system
DPCPSI
— Division of Program Coordination, Planning, and Strategic Initiatives
TOR
— Threshold of Regulation
LHV
— Laboratory of Hepatitis Viruses
SE
— SUBSTANTIALLY EQUIVALENT
SMF
— Site Master File
USTFA
— U.S. Trout Farmers Association
STAI
— STrait Anxiety Inventory
CAN
— Common Accounting Number
DEV
— DEVice Registration Number
DFOI (OC)
— Division of Freedom of Information (OC)
NCRR
— National Center for Research Resources (NIH)
CS
— Clinically significant
EPT (CFSAN)
— Epidemiology Team (CFSAN)
TSOP
— Temperature Standard Operating Procedure
OOP
— Order Of Predominance (in the ingredients statement)
CEPPO
— Chemical Emergency Preparedness and Prevention Office (EPA)
USPC
— United States Pharmacopeial Convention
ISA
— Information Systems Architecture
MSAB
— Manufacturing and Storage Adulteration Branch
PAMS
— Post-Approval Monitoring System
RIF
— reduction-in-force
DOE A (CDRH)
— Division of Enforcement A (CDRH)
ESG
— Electronic Submissions Gateway
SIR
— Society of Interventional Radiology (formerly SCVIR)
ODS
— Office of Dietary Supplements
NON
— Notice Of Non-Compliance
CM
— Chemistry and Manufacturing
RCC
— Research Coordinating Committee
PAIS
— Public Affairs and Information Staff
IFWG
— Interagency Food Working Group
FIREBIRD
— Federal Investigator REegistry for BioInformatics Research Data
IVMD
— In-Vitro Medical Device
BSD
— Blood Service Directive
VCPR
— Veterinarian Client/Patient Relationship
GGP
— Good Guidance Practice
ITS
— Information Technology Staff
TA
— Technology Administration
AIRIO
— Agency Intramural Research Integrity Officer
ERSR
— Electronic Regulatory Submissions and Review
EPRG
— European Pharmacovigilance Research Group
VATS
— Vacancy Announcement Tracking System
VMD
— Veterinariae Medicinae Doctoris
PIV
— Personal Identify Verification
UN
— unacceptable
JAN
— Japanese Adopted Names
MOD
— Miscellaneous Obligation Document
AGRICOLA
— AGRICultural On-Line Access
MHW
— Ministry of Health and Welfare (Japan)
NPSB
— Nutritional Product Studies Branch
TA
— Travel Authorization
GPP
— good programming practices
EPI
— ESSENTIAL PRESCRIBING INFORMATION
PDLB
— Pacing, Defibrillator, and Leads Branch
LSHSC
— Lipid-Soluble Heat-Stable Chemical
MON
— Memorandum of Need
OBI
— Office of Business Informatics
CRM
— corporate records management
TEB
— Therapeutics Evaluation Branch
CMG
— Cetyl Myristoleate, MSM, Glucosamine
WIC
— Women, Infants, and Children nutrition program
LHREA (CBER)
— Laboratory of Hepatitis and Related Emerging Agents (CBER)
DSS (CDRH)
— Division of Surveillance Systems (CDRH)
SMT
— Statistical Methodology Team
GOCRG
— Gastrointestinal and Other Cancer Research Group
BNF
— biotechnology notification file
TWG
— Technical Working Groups
NVTB
— Neurotoxicological and in-Vitro Toxicology Branch
RAMB
— Research Animal Medicine Branch
DDOP
— Division of Drug Oncology Products (FDA)
NSV-DO
— Nashville, Tennessee, District Office
TSEAC
— Transmissible Spongiform Encephalopathies Advisory Committee (CBER)
CORE
— Central REpository module
DPP
— Division of Psychiatry Products
RCR
— Risk Control Review
TB
— Tuberculosis Background
RL
— regulatory letter (FDA post-audit letter)
FAQD
— Frequently Asked Questions Database
DID
— Department of Infectious Diseases
OTFP
— Other Than a Food Processing facility
HIBCC
— Health Industry Business Communication Council
RFCPCS
— Retail Food and Cooperative Programs Coordination Staff
NDTI
— National Disease and Therapeutic Index
ORPS
— Office of Real Property Services
FCE
— Food Canning Establishment number
RPM
— Regulatory Procedures Manual (ORA)
ULPA
— Ultra-Low Penetration Air
MFRPS
— Manufactured Food Regulatory Program Standards
NRP
— National Response Plan (Department of Homeland Security)
WNME
— West Nile MeningoEncephalitis
OMS (NCTR)
— Office of Management Services (NCTR)
SMPS
— Standards Management Program Staff
PTR
— Platelet Transfusion Reaction
SPPA
— Strategic Partnership Program Agroterrorism initiative
WTW
— Welfare-to-Work
IBE
— individual bioequivalence
RIS
— Regulatory Information Specialist
AIS
— Abbreviated Inspection System
TOL
— total organic carbon
LAR
— Licensing Action Recommendation
DTDNFA
— Division of Therapeutic Drugs for Non-food Animals
RICHS
— Rural Information Center Health Service
NAET
— Nutrition Assessment and Evaluation Team
BSB
— Biotechnology Studies Branch (Chicago, Illinois)
DADS
— Developers and Distributors System
ARL
— Arkansas Regional Laboratory
LCT
— Labeling Compliance Team
ODA
— Orphan Drug Act of 1983
CIS
— Catastrophic Incident Supplement
NGC
— National Guideline Clearinghouse (DHHS)
MMSB
— Molecular Methods and Subtyping Branch
NSABPB
— National Surgical Adjuvant Breast and Bowel Project
M204
— Model 204 DataBase Management System
NLRC
— Nicholson Lane Research Center
VS (CBER)
— Validation Staff (CBER)
ATS
— Applied Technologies Staff
MDUFA
— Medical Device User Fee Amendments of 2007
SDSRCCG
— Study Data Standards Resources Change Control Group
RMS
— Reference Member State
RSVIGIV
— respiratory synctial virus immune globulin intravenous
OD (NCTR)
— Office of the Director (NCTR)
VIG
— Vaccinia Immune Globulin
PSS (CDRH)
— Patient Safety Staff (CDRH)
IGD
— Immunoglobin D
ECBS
— Expert Committee on Biological Standardization (WHO)
OFFAS
— Office of Field Financial and Acquisitions Services
CTOB
— Cosmetics TOxicology Branch
BSTS
— Bundled Supplement Tracking System
RRS0S
— Regulatory Review Support Staff
ORAC
— Oxygen-Radical Absorbance Capacity
DSB
— Drug Safety Oversight Board
CPMS
— Chief, Project Management Staff (CDER)
IOB
— International Operations Branch (ORA)
MCM
— Medical Countermeasures
UFC
— Unacceptable to Foreign Country
AMF
— Administrative Management of Files
LVP
— Large-Volume Parenteral
GT
— Gutta (drops)
USUHS
— Uniformed Services University of the Health Sciences
BDS
— Bureau of Drug Surveillance (Canada)
NSWL
— Naval Surface Weapons Laboratory (now FDA White Oak campus)
PAD
— Pharmacologically Active Drug
RES
— Recall Enterprise System (ORA)
SAN-DO
— San Francisco District Office
RPS
— Regulatory Policy Staff
IRA
— Immediate Response Authority
AL
— Approvable Letter
DCIS
— Design Control Inspection Strategy
ITCC
— Information Technology Coordinating Committee
NIP
— National Immunization Program (CDC)
WSHSC
— water soluble, heat stable chemicals
CTEB
— Cosmetics TEchnology Branch
FAHCT
— Foundation for Accreditation of Hematopoietic Cell Therapy
VICH
— Veterinary International Committee on Harmonisation
MRRA
— Microbial Research and Risk Assessment Staff
IBP
— Indian Black Pepper certificate
WEBSDM
— Web-based Submission Data Manager
USMS
— United States Marshals Service's
NLM
— National Library of Medicine (NIH)
TDS
— TOTAL DIET STUDY
FACS
— Food Advisory Committee Staff
RKW2
— Rockwall Building II
CH
— Clinical Hold
TEDS
— Treatment Episode Data Set
TESS
— Toxic Exposure Surveillance System
RIM
— reference information model (HL7)
SSCA
— Statistics, Surveillance, and Control Archive (CDC)
CDR
— Cognitive Drug Research
HEO
— Hispanic Employee Organization
APAC
— Allergenic Products Advisory Committee
ELPS
— establishment licensing and product surveillance
SSP
— Sector-Specific Plan
OSP
— Office of Suicide Prevention
LCH
— Laboratory of Cellular Hematology
CAST
— Calf Antibiotic and Sulfonamide Test
IAL
— Informal Action Level
SDN
— Screening Deficiency Notice
UMS
— Unified Modeling Language (Object Management Group)
PVDB
— Peripheral Vascular Devices Branch
TAH
— Transfusion-Associated Hepatitis
BBR
— Bureau of Biologics and Radiopharmaceuticals
SDSC
— Study Data Standards Catalog
OR (CVM)
— Office of Research (CVM)
SLO
— State Liaison Officer
ESC
— Electronic Submission Coodinator
WCHI
— Workers Compensation Health Initiative
RSS
— Regulatory Support Staff
EDKB
— Endocrine Disrupter Knowledge Base
TVBB
— Tumor Vaccines and Biotechnology Branch
SITP
— Strategic Information Technology Program
HCP
— HealthCare Provider
STCD
— sterile connecting device
NVSN
— New Vaccine Surveillance Network
NDCR
— New Drug Comparison Rating
IAG
— Inter-Agency Agreement
EER
— Establishment Evaluation Request
FU
— Farmacopea Ufficiale (Italian Pharmacopoeia)
SCL
— Symptom CheckList
STA
— Special Temporary Authority
CLA
— conference lodging allowance
MHSB
— Microbial Hazards Science Branch
OJDB
— Orthopedic Joint Devices Branch
CP
— Citizen Petition
VSPB
— Viral Special Pathogens Branch (CDC)
WIGI
— WithIn-Grade Increase
PSS
— Patient Safety Staff
MT
— Medical Team
RIT
— RELOCATION INCOME TAX
OST
— Office Services Team
VCTB
— Vaccine Clinical Trials Branch
CRU
— Center Recall Unit
PAL
— Public Affairs Liaison
BMB
— Bioanalytical Methods Branch
NA
— Not Approvable
HSS
— hemophilia surveillance system
CND
— Cardiovascular/Neurological Devices Branch
SDSD
— Study Data Specifications Document
SLR
— Supplement Labeling Revision
NKCA
— Natural Killer cell Cytotoxic Activity
DDR
— Donor Deferral Registry
STOP
— Safe Tables Our Priority
RFPT
— Retail Food Protection Team
SSM
— Skin Surface Microscopy
CC
— Commissioned Corps
MRFG
— Mutual Recognition Facilitating Group
CAP
— Color Additive Petition
ISS
— Integrated Summary of Safety
PKA
— Prekallikrein Activator
PT
— Preferred Term
PB
— Planning Branch
DA
— Division of Accounting
CC
— Conference Call
SDS
— Submission Data Standards
TRIMS
— Tissue Residue Information Management System
USHIK
— United States Health Information Knowledge Base
DFS
— Division File System
LBP
— Laboratory of Bacterial Polysaccharides
IDHL
— Inherently Dangerous to Human Life
OMP
— Office of Management Programs
EPL
— Effective Patent Life
SRD
— Single Rising Dose
TAA
— transfusion-associated AIDS
MGB
— Molecular Genetics Branch
DRS
— Drug-Resistance Survey
SNS
— strategic national stockpile (CDC)
MRTP
— Modified Risk Tobacco Products
CSC
— Centre for Surveillance Coordination
VMF
— Veterinary Master File
UDHQ
— Uniform Donor Health Questionnaire
TELECON
— TELEphone CONferencing
FF
— Fogarty Fellow
HCBW
— Home and Community-Based Waiver
DDSLWG
— Division Data Standards Leads Working Group
CPC
— Compliance Policy Council
SCRRB
— Scientific Compliance and Regulatory Review Branch
NOSB
— National Organic Standards Board
BCA
— Blood Center of America
GCBS
— Global Collaboration for Blood Safety (WHO)
TMO
— Trial Management Organization
BIP
— Balancing Incentive Program
DMA
— Danish Medicines Agency
RTA
— Refusal To Accept
NC
— Non-Clinical
MARS
— Mobile Automated Regulatory Services (ORA)
HDP
— Hydroxymethylene Di-Phosphonate
PSP
— Physician Special Pay
LI
— Learned Intermediary
IPM
— Import Program Manager
FIT
— FDA Internet Improvement Team
CMT
— Cosmetics Toxicology Branch
SDOS
— Study Data Operations Subcommittee
TLV
— Threshhold Limit Value
SPS
— Science and Policy Staff
IIC
— Inspector-In-Charge
NIM
— No Inspection Made
RES (OC)
— Regulations Editorial Section (OC)
BPA
— Bureau of Pharmaceutical Assessment
MPN
— Metro Park North
ABM
— Application Briefing Meeting
SDM
— Submission Data Model
NPG
— National Preparedness Goal
PLR
— Physician Labeling Rule
MID
— Manufacturer IDentifier
DIMS
— Data Information Management Staff
BASIS
— Blood Availability and Safety Inventory System
TPI
— Tan Protection Index
VE
— vaccine efficacy
RCS
— Regulations Coordination Staff
SE
— Safe and Effective
CCI
— Corrected Count Increment
MRD
— Multiple Rising Dose
CTC
— Clinical Trial Certificate (U.K.)
VCOOL
— Voluntary Country-Of-Origin Labeling
RMS
— Review Management Staff
SEDS
— Shared Establishment Data Service
OAT
— Office for the Advancement of Telehealth
EA
— Environmental Assistance
NDIRS
— New Dietary Ingredients Review Staff
MFR
— ManuFactureR
EASE
— Enterprise Administrative Support Environment
ERSB
— Emergency Response and Surveillance Branch
OIM
— Office of Information Management
FAI
— Further Action Indicated
MASC
— Manipulated Autologous Structural Cell
SIG
— strategic implementation group
HPK
— Human PharmacoKinetic
MAV
— maximum allowable variation
VS
— Visiting Scientist
NDI
— National Death Index (CDC)
CAP
— Control of Automated Processes
PER
— Pharmaceutical Evaluation Report
SCT
— Society for Clinical Trials
DC
— Discharge in Cylindrical
DPPS
— Division of Plant Product Safety
RCH
— Remove Clinical Hold
DRI
— Daily Reference Intake
RSB
— Recalls and Shortages Branch (CDER)
RSVP
— Resource reporting System Via Projects
WO
— White Oak Campus
VPS
— Veterinary Product Safety
SVP
— small-volume parenteral
MDP
— Medical Devices Program
EFGCP
— European Forum on Good Clinical Practice
SOPA
— Submission of Portion of Application
DIB
— Director, Investigations Branch
SIP
— Survey of Institutionalized Persons
DDE
— Dymanic Data Exchange
OPI
— Office of Planning and Informatics
CR
— COLLECTION REPORT
NSIP
— National Seafood Inspection Program
OPT
— Office of Pediatric Therapeutics
FSTA
— federal supervisory travel approver
IPC
— In-Process Control
RD
— Registration Dossier
FIRST
— FDA Information Retrieval System
DRA
— Division of Risk Assessment
PTS
— Product Testing Section
OEP
— Office of Emergency Preparedness (PHS)
OEI
— Official Establishment Inventory
FML
— Firms Master List
RTM
— Recall Team Member
SR
— Significant Risk
TB
— Tuberculosis Bacillus
FRAC
— FDA Research Animal Council
AGD
— action goal date
EIF
— Expected Investment Fund
DC
— Discharge Curve
DDB
— Dental Devices Branch
ERR
— Entry Review Recommended
BARC
— Beltsville Area Agricultural Research Service
SRD
— Significant Risk Device
CU
— Consumer's Union
GAT
— genome amplification testing
SPRC
— Seafood Products Research Center
NTB
— NeuroToxicology Branch
ETR
— Electronic National Tuberculosis Registry
TAV
— travel authorizations and vouchers
SUD
— Single-Use Device
SG
— Study Group
ISE
— Integrated Summary of Efficiency
SCSB
— Scientific Computer Support Branch
SD
— Scientific Director
FIH
— First-In-Human
TOPOFF
— Top Officials
PARS
— Program Activities Review Staff
WPC
— WordPerfect Character (mapping file)
COE
— Certificate of Exportability
SFB
— Spore-Forming Bacteria
NCC
— National Coordinating Committee
TRU
— Temporary Recommendations for Use
PTK
— PhotoTerapeutic Keratectomy
ML
— Manufacturer's License
AS
— Administrative Staff
LIR
— Laboratory of Immunoregulation
SIMCEN
— National Exercise Simulation Center
SM
— Starting material
PDA
— Prescription Drug Advertising
SOM
— Sensitivity of Method
SMG
— Staff Manual Guide
PSN
— Patient Safety News (FDA)
CDIS
— Component Distribution Information System
OSCI
— Office of SCIence
WIB
— Western ImmunoBlot
PDI
— Post-Donation Information
DC
— Discharge Capacity
SS
— Serving Size
SE
— Salmonella Enteriditis
RCT
— ReCall Team
SEB
— Subsequent Entry Biologic
FR.P.
— Pharmacopee Francaise (French Pharmacopoeia)
RTR
— Recall Termination Recommendation
TPD
— TheTherapeutic Products Directorate
NGB
— National Guard Bureal
SIF
— Seafood HACCP Importer Form
CSC
— Computational Science Center
RDT
— rising dose tolerance
RFR
— Reportable Food Registry
SA
— Sustained Action
CTO
— Clinical Trial Outline
MAT
— Modular Antigen Transporter
CDR
— Clinical Drug Request
PFL
— Professional Flexible Labeling
TPH
— Tropical Public Health
AD
— Action Due
AT
— Acquisitions Team
FPL
— Final Printed Labeling
RPS
— Regulated Product Submissions
TK
— Toxicokinetics
DSC
— Drug Safety Communication
DEPI
— Division of EPIpidemiology
PAGE
— PolyAcrylimide Gel Electrophoresis
IDM
— Informational Disclosure Manual
GSP
— Good Statistics Practice
OD (CBER)
— Office of the Director (CBER)
WSL
— Washington Seafood Laboratory
UA
— UrinAnalysis
DLR
— Drug Listing Rule
SGI
— Summer Genetics Institute
BTA
— BioTerroism Act of 2002
FII
— FarmIndustria Italy
MJ
— Major Amendment
RFD
— Request for Designation
IEE
— Intervention Effect Estimate
FA
— Filing Action
DMB
— Dockets Management Branch
TA
— Temporary Abeyance
RP
— Resident Post
GG
— Goal Group
DDS
— Deputy Director for Safety (CDER)
DC
— Discharge Conduit
RIPA
— radioimunoprecipitation assay
TO
— table of oganization
RR
— Recall Recommendation
MWG
— Milk Working Group
RH
— responsible head
NVC
— National Vaccine Commission
ITF
— Inspection Task Force (CBER)
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