[Federal Register Volume 65, Number 152 (Monday, August 7, 2000)]
[Notices]
[Pages 48246-48247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19941]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1407]


International Conference on Harmonisation; Draft Guidance on 
Safety Pharmacology Studies for Human Pharmaceuticals; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``S7 Safety Pharmacology 
Studies for Human Pharmaceuticals.'' The draft guidance was prepared 
under the auspices of the International Conference on Harmonisation of 
Technical Requirements for Registration of Pharmaceuticals for Human 
Use (ICH). The draft guidance describes general principles and 
recommendations for safety pharmacology evaluations. The draft guidance 
is intended to help protect clinical trial participants and patients 
receiving marketed products from potential adverse reactions to 
pharmaceuticals and to avoid unnecessary use of animals and other 
resources.

DATES: Submit written comments on the draft guidance by September 6, 
2000.

ADDRESSES: Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Copies of the draft guidance are 
available on the Internet at http://www.fda.gov/cder/guidance/index.htm 
or http://www.fda.gov/cber/publications.htm. Submit written requests 
for single copies of the draft guidance to the Drug Information Branch 
(HFD-210), Center for Drug Evaluation and Research, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, or the Office 
of Communication, Training, and Manufacturers Assistance (HFM-40), 
Center for Biologics Evaluation and Research (CBER), 1401 Rockville 
Pike, Rockville, MD 20852-1448, 301-827-3844, FAX 888-CBERFAX. Send two 
self-addressed adhesive labels to assist the office in processing your 
requests.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Joseph J. DeGeorge, Center for Drug 
Evaluation and Research (HFD-24), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5476.
    Regarding the ICH: Janet J. Showalter, Office of International 
Programs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-0864.

SUPPLEMENTARY INFORMATION: In recent years, many important initiatives 
have been undertaken by regulatory authorities and industry 
associations to promote international harmonization of regulatory 
requirements. FDA has participated in many meetings designed to enhance 
harmonization and is committed to seeking scientifically based 
harmonized technical procedures for pharmaceutical development. One of 
the goals of harmonization is to identify and then reduce differences 
in technical requirements for drug development among regulatory 
agencies.
    ICH was organized to provide an opportunity for tripartite 
harmonization initiatives to be developed with input from both 
regulatory and industry representatives. FDA also seeks input from 
consumer representatives and others. ICH is concerned with 
harmonization of technical requirements for the registration of 
pharmaceutical products among three regions: The European Union, Japan, 
and the United States. The six ICH sponsors are the European 
Commission, the European Federation of Pharmaceutical Industries 
Associations, the Japanese Ministry of Health and Welfare, the Japanese 
Pharmaceutical Manufacturers Association, the Centers for Drug 
Evaluation and Research and Biologics Evaluation and Research, FDA, and 
the Pharmaceutical Research and Manufacturers of America. The ICH 
Secretariat, which coordinates the preparation of documentation, is 
provided by the International Federation of Pharmaceutical 
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of 
the ICH sponsors and the IFPMA, as well as observers from the World 
Health Organization, the Canadian Health Protection Branch, and the 
European Free Trade Area.
    In accordance with FDA's good guidance practices (GGP's) (62 FR 
8961, February 27, 1997), this document is being called a guidance, 
rather than a guideline.
    To facilitate the process of making ICH guidances available to the 
public, the agency is changing its procedure for publishing ICH 
guidances. Beginning April 2000, we will no longer include the text of 
ICH guidances in the Federal Register. Instead, we will publish a 
notice in the Federal Register announcing the availability of an ICH 
guidance. The ICH guidance will be placed in the docket and can be 
obtained through regular agency sources (see the ADDRESSES section). 
The draft guidance will be left in the original ICH format. The final 
guidance will be reformatted to conform to GGP style before 
publication.

[[Page 48247]]

    In March 2000, the ICH Steering Committee agreed that a draft 
guidance entitled ``S7 Safety Pharmacology Studies for Human 
Pharmaceuticals'' should be made available for public comment. The 
draft guidance is the product of the Safety Expert Working Group of the 
ICH. Comments about this draft will be considered by FDA and the Safety 
Expert Working Group.
    The draft guidance describes general principles and recommendations 
for safety pharmacology evaluations. The draft guidance is intended to 
help protect clinical trial participants and patients receiving 
marketed products from potential adverse reactions to pharmaceuticals 
and avoid unnecessary use of animals and other resources. The draft 
guidance generally applies to new chemical entities and biotechnology-
derived products for human use. The draft guidance may be applied to 
marketed pharmaceuticals when appropriate. For example, adverse 
clinical events, a new patient population, or a new route of 
administration may raise concerns not previously addressed.
    This draft guidance represents the agency's current thinking on 
safety pharmacology studies for human pharmaceuticals. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes, 
regulations, or both.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance by September 6, 
2000. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
draft guidance and received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 31, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-19941 Filed 8-2-00; 3:33 pm]
BILLING CODE 4160-01-F