Department of Health and Human Services
Food and Drug Administration
Fiscal Year 2005

FOOD AND DRUG ADMINISTRATION

Glossary of Acronyms

A B C D E F G H I J K L M N O P Q R S T U V W

510(k)

Pre-market notification (Medical devices substantially equivalent to products already on the market)

A
 
AADA

Abbreviated Antibiotic Drug Application

AAFCO

American Association of Feed Control Officials

ADE

Adverse Drug Event

ADAA

Animal Drug Availability Act of 1996

ADR

Adverse Drug Report

ADUFA
Animal Drug User Fee Act
AERS

Adverse Events Reporting System

AHI

Animal Health Institute

AIDS

Acquired Immune Deficiency Syndrome

AMDUCA

Animal Medicinal Drug Use Clarification Act

ANADA

Abbreviated New Animal Drug Application

ANDA

Abbreviated New Drug Application

ANPR

Advanced Notice of Proposed Rulemaking

ANSI

American National Standards Institute

APHIS

Animal Plant and Health Inspection Service (USDA)

AR

Anti-microbial Resistance

AVMA

American Veterinary Medical Association

B

BIMO

Bioresearch Monitoring

BIMS

Biological Investigational New Drug Application Management System

BCCP

Business Continuity and Contingency Plan

BLA

Biologics License Application

BLT

Blood Logging and Tracking System

BSE

Bovine Spongiform Encephalopathy (Mad Cow Disease)

BSL

Biosafety Level

BT

Bioterrorism

C

CABS

Conformity Assessment Bodies

CAERS

CFSAN Adverse Event Reporting System

CARS

Compliance Achievement Reporting System

CBER

Center for Biologics Evaluation and Research (FDA)

CDC

Centers for Disease Control and Prevention

CDER

Center for Drug Evaluation and Research (FDA)

CDRH

Center for Devices and Radiological Health (FDA)

CFO

Chief Financial Officer

CFSAN

Center for Food Safety and Applied Nutrition (FDA)

CGMPs

Current Good Manufacturing Practices

CIP

Critical Infrastructure Protection

CJD

Creutzfeldt-Jakob disease

CMC

Chemistry, Manufacturing, and Controls

CWD

Chronic Wasting Disease

COMSTAS

Compliance Status Information System

COBOL

Common Business Oriented Language

COOP

Continuity of Operations

CRADA

Cooperative Research and Development Agreement

CRO

Contract Research Organization

CRS

Contamination Response System

CT

Counter terrorism

CTS

Correspondence Tracking System

CVM

Center for Veterinary Medicine (FDA)

CWD

Chronic Wasting Disease

D

DHHS

Department of Health and Human Services

DNA

Deoxyribonucleic Acid

DOD

Department of Defense

DOL

Department of Labor

DQRS

Drug Quality Reporting System

DRLS

Drug Registration and Listing System

DSHEA

Dietary Supplement Health and Education Act

E

EDR

Electronic Document Room

EDMS

Electronic Data Management System

EIP

Emerging Infection Program

EIR

Establishment Inspection Report

ELA

Establishment License Application

EPA

Environmental Protection Agency

ERS

Economic Research Service

ETS

Environmental Tobacco Smoke

EU

European Union

F

FAA

Federal Aviation Administration

FACTS

Field Accomplishment and Compliance Tracking System

FAIR Act

Act Federal Activities Inventory Reform Act

FAO

Food and Agricultural Organization (United Nations)

FAS

Foreign Agriculture Service (USDA)

FDA

Food and Drug Administration

FDAMA

Food and Drug Administration Modernization Act of 1997

FFD&C Act

Federal Food, Drug and Cosmetic Act

FIS

Field Information System

FLQ

Fluoroquinolone

FMD

Foot and Mouth Disease

FMFIA

Federal Manager’s Financial Integrity Act

FORCG

Food Outbreak Response Coordination Group

FPL

Final Printed Label

FPLA

Fair Packaging and Labeling Act

FSI

Food Safety Initiative (National)

FSIS

Food Safety Inspection Service (USDA)

FTC

Federal Trade Commission

FTE

Full-time Equivalent

FY

Fiscal Year (October - September)

G

GAO

General Accounting Office

GAPs

Good Agricultural Practices

GATT

General Agreement on Tariffs and Trade

GeMCRIS

Genetic Modification Clinical Research Information System

GLP

Good Laboratory Practices

GMO

Genetically Modified Organisms

GMPs

Good Manufacturing Practices

GPRA

Government Performance and Results Act of 1993

GRAS

Generally Recognized as Safe Food Ingredients

GSFA

General Standards for Food Additives

GTIS

Gene Therapy Information System

H

HACCP

Hazard Analysis Critical Control Points

HCV

Hepatitis C Virus

HDE

Humanitarian Device Exemption

HIV

Human Immunodeficiency Virus

HUD

Humanitarian Use Device

I

IAG

Interagency Agreement

ICAAC

Interscience Conference on Antimicrobial Agents and Chemotherapy

ICH

International Conference on Harmonization

IDE

Investigational Device Exemption

INAD

Investigational New Animal Drug

INADA

Investigational New Animal Drug Application

IND

Investigational New Drug

IOM

Institute of Medicine

IRB

Institutional Review Board

ISLI

International Life Sciences Institute

ISO

International Standards Organization

ISRS

Individual Safety Reports

IT

Information Technology

IVD

In Vitro Diagnostic

J

JECFA

Joint Expert Committee on Food Additives

JIFSAN

Joint Institute for Food Safety and Applied Nutrition

JINAD

Generic Investigational New Animal Drug

L

LACF

Low Acid Canned Foods

LAN

Local Area Network

LBITF

Least Burdensome Industry Task Force

M

MALDI

Matrix Assisted Laser Desorption Ionization

MAB

Metastable Atom Bombardment

MATS

Management Assignment Tracking System

MBM

Meat and Bone Meal

MDR

Medical Device Reporting System

MDUFMA

Medical Device User Fee and Modernization Act

MedSun

Medical Product Surveillance Network

MERS-TM

Medical Event Reporting System for Transfusion Medicine

MFA

Medicated Feed Application

MMBM

Mammalian Meat and Bone Meal

MOU

Memorandum of Understanding

MPRIS

Mammography Program Reporting and Information Systems

MQSA

Mammography Quality Standards Act

MRA

Mutual Recognition Agreement

MUMS

Minor Use/Minor Species

N

NADA

New Animal Drug Application

NAFTA

North American Free Trade Agreement

NAFTA TWG

TWG North American Free Trade Agreement Technical Working Group

NAHMS

National Animal Health Monitoring System

NARMS

National Antimicrobial Resistance Monitoring System

NAS

National Academy of Sciences

NASS

National Agricultural Statistics Survey

NAT

Nucleic Acid Test

NCCLS

National Committee on Clinical Laboratory Standards

NCI

National Cancer Institute

NCIE

Notice of Claimed Investigational Exemptions

NCTR

National Center for Toxicological Research (FDA)

NDA

New Drug Application

NDE/MIS

New Drug Evaluation Management Information System

NIAID

National Institute of Allergy and Infectious Diseases

NIBSC

National Institute for Biological Standards and Control

NIDA

National Institute on Drug Abuse

NIEHS

National Institute for Environmental Health Sciences

NIH

National Institutes of Health

NLEA

Nutrition Labeling and Education Act

NME

New Molecular Entity

NOH

Notice of Hearing

NPR

National Partnership for Reinventing Government

NPRM

Notice of Proposed Rulemaking

NRC

National Research Council

NTP

National Toxicology Program

nvCJD

new variant Creutzfeldt-Jakob disease

NVPO

National Vaccine Program Office

O

OASIS

Operational and Administrative System for Import Support

OBRR

Office of Blood Research and Review (CBER)

OCTGT

Office of Cellular, Tissues and Gene Therapies (CBER)

OPA

Office of Premarket Approvals (CFSAN)

ORA

Office of Regulatory Affairs (FDA)

ORISE

Oak Ridge Institute for Science and Education

OSHA

Occupational Safety and Health Administration

OTC

Over-the-Counter

OTR

Office of Testing and Research (CDER)

OTRR

Office of Therapeutics Research and Review (CBER)

OVRR

Office of Vaccines Research and Review (CBER)

P

PAS

Public Affairs Specialist (FDA)

PDPs

Product Development Protocols

PDUFA

Prescription Drug User Fee Act of 1992

PERV

Porcine endogenous retrovirus

PIFSI

Produce and Food Safety Initiative

PISI

Protocol Investigator Site Inspection

PLA

Product License Application

PMA

Premarket Approval (Application to market medical device that requires Premarket approval)

PMN

Premarket Notification

PODS

Project-Oriented Data System

PQRI

Product Quality Research Initiative

Q

QSAR

Quantitative Structure Activity Relationship

QSIT

Quality System Inspection Technique

R

RA

Rheumatoid Arthritis

RCHSA

Radiation Control for Health and Safety Act

REGO

Reinventing Government Initiative

RIMS

Regulatory Information Management Staff (CBER)

RMS-BLA

Regulatory Management System-Biologics License Application

RVIS

Residue Violation Information System

S

SAB

Science Advisory Board

SAMHSA

Substance Abuse and Mental Health Services Administration

SBREFA

Small Business Regulatory Enforcement Fairness Act

SE

Salmonella Enteriditis

SN/AEMS

Special Nutritional Adverse Events Monitoring System

STARS

Submission Tracking and Review System

StmDT104

Salmonella Tphimurium DT 104

T

TB

Tuberculosis

Tof

Time of flight

TRIMS

Tissue Residue Information System

U

UK

United Kingdom

UMCP

University of Maryland-College Park

USDA

United States Department of Agriculture

V

VAERS

Vaccine Adverse Event Reporting System

vCJD

variant Creutzfeldt-Jakob disease

VEE

Venezuelean Equine Encephalitis

VICH

Veterinary International Cooperation on Harmonization

VFD

Veterinary Feed Directive

VICH

Veterinary International Conference on Harmonization

W

WHO

United Nations World Health Organization

WNV

West Nile Virus

WTO

World Trade Organization