[Federal Register Volume 65, Number 154 (Wednesday, August 9, 2000)]
[Notices]
[Pages 48720-48721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20172]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1408]


International Conference on Harmonisation; Draft Guidance on 
Principles for Clinical Evaluation of New Antihypertensive Drugs; 
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availability of a draft guidance entitled ``E12A Principles for 
Clinical Evaluation of New Antihypertensive Drugs.'' The draft 
guidance, prepared under the auspices of the International Conference 
on Harmonisation of Technical Requirements for Registration of 
Pharmaceuticals for Human Use (ICH), was designated an ICH principle 
document. The draft guidance is intended to provide general principles 
for the clinical evaluation of new antihypertensive drugs. It describes 
the core principles accepted in the three ICH regions for the 
evaluation of new antihypertensive drugs, including assessments of 
efficacy and safety and choice of study population.

DATES: Submit written comments on the draft guidance by November 7, 
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ADDRESSES: Submit written comments on the draft guidance to the Dockets 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 Copies of the draft guidance are 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for single copies of the draft guidance to the Drug Information Branch 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. Requests and comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Robert Temple, 
Center for Drug Evaluation and Research (HFD-4), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-6758.
    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

[[Page 48721]]

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 and biological product 
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.
    To facilitate the process of making ICH guidances available to the 
public, the agency is changing its procedures for publishing ICH 
guidances. Beginning April 2000, we will follow the same procedures we 
follow with other agency guidances. Rather than including the text of 
ICH guidances in the Federal Register, 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.
    In March 2000, the ICH Steering Committee agreed that a draft 
guidance entitled ``E12A Principles for Clinical Evaluation of New 
Antihypertensive Drugs'' should be made available for public comment. 
The draft guidance, which is the product of the Efficacy Expert Working 
Group of the ICH, was designated an ICH principle document. Because 
requirements of the three ICH regions differ in some specifics, this 
ICH principle document will not be subject to the usual ICH step 
procedures leading to a fully harmonized document. Comments about this 
draft will be forwarded to the three regulatory parties for 
consideration.
    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 principle document.
    The draft guidance is intended to provide general principles for 
the clinical evaluation of new antihypertensive drugs. It describes 
core principles that are accepted in the three ICH regions for the 
evaluation of antihypertensives, including assessments of efficacy and 
safety and choice of study population. The draft guidance is meant to 
be used together with other ICH clinical guidances.
    This draft guidance represents the agency's current thinking on the 
clinical evaluation of new antihypertensive drugs. 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 November 7, 
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: August 2, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-20172 Filed 8-8-00; 8:45 am]
BILLING CODE 4160-01-F