[Federal Register Volume 74, Number 30 (Tuesday, February 17, 2009)]
[Notices]
[Pages 7445-7446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-3168]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0006]


International Conference on Harmonisation; Draft Guidance on S9 
Nonclinical Evaluation for Anticancer 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availability of a draft guidance entitled ``S9 Nonclinical Evaluation 
for Anticancer 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 The draft guidance was prepared under 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 The draft guidance provides recommendations for nonclinical 
studies for the development of pharmaceuticals, including both drugs 
and biotechnology-derived products, intended to treat patients with 
advanced cancer. The recommendations describe the type and timing of 
nonclinical studies to support an investigational new drug application 
(IND) and the submission of a new drug application (NDA) or biologics 
license application (BLA). The draft guidance is intended to provide 
information on internationally accepted recommendations for nonclinical 
studies to facilitate the development of anticancer pharmaceuticals.

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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by April 20, 2009.

ADDRESSES: Submit written comments on the draft guidance to the 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 electronic 
comments to http://www.regulations.gov. 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single copies of the draft guidance to the Division of Drug 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

[[Page 7446]]

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: John K. 
Leighton, Center for Drug Evaluation and Research (HFD-106), Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 2204, 
Silver Spring, MD 20993-0002, 301-796-2330; or Mercedes Serabian, 
Center for Biologics Evaluation and Research (HFM-760), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
5377.
    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 November 2008, the ICH Steering Committee agreed that a draft 
guidance entitled ``S9 Nonclinical Evaluation for Anticancer 
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 provides guidance for nonclinical studies for 
the development of pharmaceuticals, including both drugs and 
biotechnology-derived products, intended to treat patients with 
advanced cancer. The recommendations describe the type and timing of 
nonclinical studies to support an IND and the submission of an NDA or 
BLA.
    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 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) written or electronic 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/cder/guidance/index.htm, 
or http://www.fda.gov/cber/guidelines.htm.

    Dated: February 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3168 Filed 2-13-09; 8:45 am]
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