[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR14.100]

[Page 154-157]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 14_PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE--Table of Contents
 
                 Subpart F_Standing Advisory Committees
 
Sec.  14.100  List of standing advisory committees.


    Standing advisory committees and the dates of their establishment 
are as follows:
    (a) Office of the Commissioner--(1) Board of Tea Experts.
    (i) Date established: March 2, 1897.
    (ii) Function: Advises on establishment of uniform standards of 
purity, quality, and fitness for consumption of all tea imported into 
the United States under 21 U.S.C. 42.
    (2) Science Board to the Food and Drug Administration.
    (i) Date established: June 26, 1992.

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    (ii) Function: The board shall provide advice primarily to the 
agency's Senior Science Advisor and, as needed, to the Commissioner and 
other appropriate officials on specific complex and technical issues as 
well as emerging issues within the scientific community in industry and 
academia. Additionally, the board will provide advice to the agency on 
keeping pace with technical and scientific evolutions in the fields of 
regulatory science; on formulating an appropriate research agenda; and 
on upgrading its scientific and research facilities to keep pace with 
these changes. It will also provide the means for critical review of 
agency sponsored intramural and extramural scientific research programs.
    (3) Pediatric Advisory Committee.
    (i) Date established: June 18, 2004.
    (ii) Function: Advises on pediatric therapeutics, pediatric 
research, and other matters involving pediatrics for which the Food and 
Drug Administration has regulatory responsibility.
    (b) Center for Biologics Evaluation and Research--(1) Allergenic 
Products Advisory Committee.
    (i) Date established: July 9, 1984.
    (ii) Function: Reviews and evaluates data on the safety and 
effectiveness of allergenic biological products intended for use in the 
diagnosis, prevention, or treatment of human disease.
    (2) Cellular, Tissue and Gene Therapies Advisory Committee.
    (i) Date established: October 28, 1988.
    (ii) Function: Reviews and evaluates available data relating to the 
safety, effectiveness, and appropriate use of human cells, human 
tissues, gene transfer therapies and xenotransplantation products which 
are intended for transplantation, implantation, infusion, and transfer 
in the prevention and treatment of a broad spectrum of human diseases 
and in the reconstruction, repair or replacement of tissues for various 
conditions. The Committee also considers the quality and relevance of 
FDA's research program which provides scientific support for the 
regulation of these products, and makes appropriate recommendations to 
the Commissioner of Food and Drugs.
    (3) Blood Products Advisory Committee.
    (i) Date established: May 13, 1980.
    (ii) Function: Reviews and evaluates data on the safety and 
effectiveness, and appropriate use of blood products intended for use in 
the diagnosis, prevention, or treatment of human diseases.
    (4) [Reserved]
    (5) Vaccines and Related Biological Products Advisory Committee.
    (i) Date established: December 31, 1979.
    (ii) Function: Reviews and evaluates data on the safety and 
effectiveness of vaccines intended for use in the diagnosis, prevention, 
or treatment of human diseases.
    (6) Transmissible Spongiform Encephalopathies Advisory Committee.
    (i) Date established: June 21, 1995.
    (ii) Function: Reviews and evaluates available scientific data 
concerning the safety of products which may be at risk for transmission 
of spngiform encephalopathies having an impact on the public health.
    (c) Center for Drug Evaluation and Research--(1) Anesthetic and Life 
Support Drugs Advisory Committee.
    (i) Date established: May 1, 1978.
    (ii) Function: Reviews and evaluates data on the safety and 
effectiveness of marketed and investigational human drugs for use in the 
field of anesthesiology and surgery.
    (2) Anti-Infective Drugs Advisory Committee.
    (i) Date established: October 7, 1980.
    (ii) Function: Reviews and evaluates available data concerning the 
safety and effectiveness of marketed and investigational human drug 
products for use in the treatment of infectious diseases and disorders.
    (3) Antiviral Drugs Advisory Committee.
    (i) Date established: February 15, 1989.
    (ii) Function: Reviews and evaluates available data concerning the 
safety and effectiveness of marketed and investigational human drug 
products for use in the treatment of acquired immune deficiency syndrome 
(AIDS), AIDS-related complex (ARC), and other viral, fungal, and 
mycobacterial infections.
    (4) Arthritis Advisory Committee.
    (i) Date established: April 5, 1974.
    (ii) Function: Reviews and evaluates data on the safety and 
effectiveness of

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marketed and investigational human drugs for use in arthritic 
conditions.
    (5) Cardiovascular and Renal Drugs Advisory Committee.
    (i) Date established: August 27, 1970.
    (ii) Function: Reviews and evaluates data on the safety and 
effectiveness of marketed and investigational human drugs for use in 
cardiovascular and renal disorders.
    (6) Dermatologic and Ophthalmic Drugs Advisory Committee.
    (i) Date established: October 7, 1980.
    (ii) Function: Reviews and evaluates available data concerning the 
safety and effectiveness of marketed and investigational human drug 
products for use in the treatment of dermatologic and ophthalmic 
disorders.
    (7) Drug Safety and Risk Management Advisory Committee.
    (i) Date established: May 31, 1978.
    (ii) Function: Reviews and evaluates data on risk management plans, 
provides active surveillance methodologies, trademark studies, 
methodologies for risk management communication, and related issues.
    (8) Endocrinologic and Metabolic Drugs Advisory Committee.
    (i) Date established: August 27, 1970.
    (ii) Function: Reviews and evaluates data on the safety and 
effectiveness of marketed and investigational human drugs for use in 
endocrine and metabolic disorders.
    (9) Advisory Committee for Reproductive Health Drugs.
    (i) Date established: March 23, 1978.
    (ii) Function: Reviews and evaluates data on the safety and 
effectiveness of marketed and investigational human drugs for use in the 
practice of obstetrics, gynecology, and related specialties.
    (10) Gastrointestinal Drugs Advisory Committee.
    (i) Date established: March 3, 1978.
    (ii) Function: Reviews and evaluates data on the safety and 
effectiveness of marketed and investigational human drugs for use in 
gastrointestinal diseases.
    (11) Oncologic Drugs Advisory Committee.
    (i) Date established: September 1, 1978.
    (ii) Function: Reviews and evaluates data on the safety and 
effectiveness of marketed and investigational human drugs for use in 
treatment of cancer.
    (12) Peripheral and Central Nervous System Drugs Advisory Committee.
    (i) Date established: June 4, 1974.
    (ii) Function: Reviews and evaluates data on the safety and 
effectiveness of marketed and investigational human drugs for use in 
neurological disease.
    (13) Psychopharmacologic Drugs Advisory Committee.
    (i) Date established: June 4, 1974.
    (ii) Function: Reviews and evaluates data on the safety and 
effectiveness of marketed and investigational human drugs for use in the 
practice of psychiatry and related fields.
    (14) Pulmonary-Allergy Drugs Advisory Committee.
    (i) Date established: February 17, 1972.
    (ii) Function: Reviews and evaluates data on the safety and 
effectiveness of marketed and investigational human drugs for use in the 
treatment of pulmonary disease and diseases with allergic and/or 
immunologic mechanisms.
    (15) Medical Imaging Drugs Advisory Committee.
    (i) Date established: August 30, 1967.
    (ii) Function: Reviews and evaluates data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in diagnostic and therapeutic procedures using radioactive 
pharmaceuticals and contrast media used in diagnostic radiology.
    (16) Advisory Committee for Pharmaceutical Science and Clinical 
Pharmacology.
    (i) Date established: January 22, 1990.
    (ii) Function: The committee shall provide advice on scientific, 
clinical and technical issues related to safety and effectiveness of 
drug products for use in the treatment of a broad spectrum of human 
diseases, the quality characteristics which such drugs purport or are 
represented to have and as required, any other product for which the 
Food and Drug Administration has regulatory responsibility, and make 
appropriate recommendations to the Commissioner of Food and Drugs. The 
Committee may also review agency sponsored intramural and extramural

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biomedical research programs in support of FDA's drug regulatory 
responsibilities and its critical path initiatives related to improving 
the efficacy and safety of drugs and improving the efficiency of drug 
development.
    (17) Nonprescription Drugs Advisory Committee.
    (i) Date established: August 27, 1991.
    (ii) Functions: The committee reviews and evaluates available data 
concerning the safety and effectiveness of over-the-counter 
(nonprescription) human drug products for use in the treatment of a 
broad spectrum of human symptoms and diseases.
    (18) Pharmacy Compounding Advisory Committee.
    (i) Date established: February 12, 1998.
    (ii) Function: Provides advice on scientific, technical, and medical 
issues concerning drug compounding by pharmacists and licensed 
practitioners.
    (d) Center for Devices and Radiological Health--(1) Medical Devices 
Advisory Committee.
    (i) Date established: October 27, 1990.
    (ii) Function: Reviews and evaluates data on the safety and 
effectiveness of marketed and investigational devices and makes 
recommendations for their regulation.
    (2) Device Good Manufacturing Practice Advisory Committee.
    (i) Date established: May 17, 1987.
    (ii) Function: Reviews proposed regulations for good manufacturing 
practices governing the methods used in, and the facilities and controls 
used for, the manufacture, packing, storage, and installation of 
devices, and makes recommendations on the feasibility and reasonableness 
of the proposed regulations.
    (3) Technical Electronic Product Radiation Safety Standards 
Committee.
    (i) Date established: October 18, 1968.
    (ii) Function: Advises on technical feasibility, reasonableness, and 
practicability of performance standards for electronic products to 
control the emission of radiation under 42 U.S.C. 263f(f)(1)(A).
    (4) National Mammography Quality Assurance Advisory Committee.
    (i) Date established: July 6, 1993.
    (ii) Function: Advises on developing appropriate quality standards 
and regulations for the use of mammography facilities.
    (e) National Center for Toxicological Research--Science Advisory 
Board.
    (1) Date established: June 2, 1973.
    (2) Function: Advises on establishment and implementation of a 
research program that will assist the Commissioner of Food and Drugs 
tofulfill regulatory responsibilities.
    (f) Center for Veterinary Medicine--Veterinary Medicine Advisory 
Committee.
    (1) Date established: April 24, 1984.
    (2) Function: Reviews and evaluates available data concerning safety 
and effectiveness of marketed and investigational new animal drugs, 
feeds, and devices for use in the treatment and prevention of animal 
disease and increased animal production.
    (g) Center for Food Safety and Applied Nutrition--Food Advisory 
Committee.
    (1) Date established: December 15, 1991.
    (2) Function: The committee provides advice on emerging food safety, 
food science, and nutrition issues that FDA considers of primary 
importance in the next decade.

[54 FR 9036, Mar. 3, 1989]

    Editorial Note: For Federal Register citations affecting Sec.  
14.100, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.