[Federal Register Volume 74, Number 216 (Tuesday, November 10, 2009)]
[Notices]
[Pages 58024-58025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-27000]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0528]


International Conference on Harmonisation; Draft Guidance on E7 
Studies in Support of Special Populations; Geriatrics; Questions and 
Answers; 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availability of a draft guidance entitled ``E7 Studies in Support of 
Special Populations: Geriatrics; Questions & Answers.'' The draft 
guidance was prepared under the auspices of the International 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 questions and answers 
(Q&A) guidance addresses the representation of geriatric patients in 
the clinical database, including representation of special 
characteristics of the geriatric patient population. The Q&As are 
intended to provide guidance on this issue.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit electronic or written comments on the draft guidance 
by January 11, 2010.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit written requests for single copies of the draft guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 
2201, Silver Spring, MD 20993-0002; or the Office of Communication, 
Outreach and Development (HFM-40), Center for Biologics Evaluation and 
Research (CBER), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448. The guidance may also be obtained by mail by 
calling CBER at 1-800-835-4709 or 301-827-1800. Send two self-addressed 
adhesive labels to assist the office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Nisha Jain, Center for Biologics Evaluation 
and Research (HFM-392), Food and Drug Administration, 1401 Rockville 
Pike, Rockville, MD 20850, 301-827-6110; or Robert Temple, Center for 
Drug Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 4212, 301-796-2270.
    Regarding the ICH: Michelle Limoli, Office of International 
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4480.

SUPPLEMENTARY INFORMATION:

I. Background

    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, Labour, 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, Health Canada, and the European Free Trade Area.
    In September 2009, the ICH Steering Committee agreed that a draft 
guidance entitled ``E7 Studies in Support of Special Populations: 
Geriatrics; Questions & Answers'' should be made available for public 
comment. The draft guidance is the product of the E7(R1) Implementation 
Working Group of the ICH. Comments about this draft will be considered 
by FDA and the E7(R1) Implementation Working Group.
    The draft Q&A guidance addresses the representation of geriatric 
patients in the clinical database, including special characteristics of 
the geriatric patient population. In view of the growing geriatric 
population (elderly and very elderly, i.e., over 75 years of age) and 
the recent advances in the field of geriatrics since the ICH E7 
guidance issued (59 FR 39398, August 2, 1994), the importance of 
geriatric data (including data for the very elderly) in a drug 
evaluation program has increased. The Q&As are intended to provide 
guidance on this issue.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on this topic. 
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

[[Page 58025]]

such approach satisfies the requirements of the applicable statutes and 
regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments on the draft guidance. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: November 5, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27000 Filed 11-9-09; 8:45 am]
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