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