
[Federal Register: February 17, 2009 (Volume 74, Number 30)]
[Notices]
[Page 7445-7446]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17fe09-86]

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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International Conference on Harmonisation; Draft Guidance on S9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availability of a draft guidance entitled ``S9 Nonclinical Evaluation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 The draft guidance was prepared under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 The draft guidance provides recommendations for nonclinical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 The draft guidance is intended to provide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draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written comments on the draft guidance to the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single copies of the draft guidance to the Division of Drug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]

BILLING CODE 4160-01-S
