[Federal Register Volume 74, Number 12 (Wednesday, January 21, 2009)]
[Notices]
[Pages 3610-3611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-936]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0007]


Draft Guidance for Industry on Animal Models--Essential Elements 
to Address Efficacy Under the Animal Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: FDA is announcing the availability of a draft guidance 
entitled ``Animal Models--Essential Elements to Address Efficacy Under 
the Animal Rule.'' When human efficacy studies are neither ethical nor 
feasible, animal efficacy studies may be relied on under the Animal 
Rule to support approval or licensure of a drug or biological product. 
This guidance identifies and discusses the critical characteristics of 
an animal model that should be addressed when developing products for 
approval under the Animal Rule. The guidance is intended to help 
sponsors determine whether the model meets the requirements of the 
Animal Rule.

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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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 March 23, 2009.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 
Office of Communication, Training, and Manufacturers Assistance (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in 
processing your requests. The draft guidance may also be obtained by 
mail by calling CBER at 1-800-835-4709 or 301-827-1800. Send one self-
addressed adhesive label to assist that office in processing your 
requests. Submit written comments on the draft guidance to the Division 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. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Rosemary Roberts, Office of Counter-Terrorism and Emergency 
Coordination, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3342, Mail Stop 
3329, Silver Spring, MD 20993, 301-796-2210 or
    Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-
827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Animal Models--Essential Elements to Address Efficacy Under 
the Animal Rule.'' The purpose of this draft guidance is to assist 
sponsors to identify the critical characteristics of an animal model 
that should be addressed when efficacy of an investigational product 
will be established under the ``Animal Rule'' (see 21 CFR 314.600; 21 
CFR 601.90). Critical characteristics include, but are not limited to, 
information regarding the natural history of the condition to be 
treated in humans and animals, the challenge agent, route of exposure 
to the challenge agent, and the timing of intervention with the study 
drug. Data from human experience with the etiologic agent or with the 
intervention, when available, may support applicability of the animal 
model. The information described in the draft guidance is relevant for 
any animal model being considered as a basis for establishing efficacy 
under the Animal Rule and is intended to help determine whether the 
model meets the requirements of the Animal Rule.
    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 animal 
models when addressing efficacy under the animal rule. 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 regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that

[[Page 3611]]

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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder.guidance/index.htm, http://www.fda.gov/cber/guidelines.htm or http://www.regulations.gov.

    Dated: January 12, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-936 Filed 1-16-09; 8:45 am]
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