[Federal Register Volume 79, Number 106 (Tuesday, June 3, 2014)]
[Notices]
[Pages 31950-31951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12807]



[[Page 31950]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Product Development Under the Animal Rule, Revised Draft Guidance 
for Industry; 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availability of a revised draft guidance for industry entitled 
``Product Development Under the Animal Rule.'' When human efficacy 
studies are neither ethical nor feasible, FDA may rely on adequate and 
well-controlled animal efficacy studies to support approval of a drug 
or licensure of a biological product under the Animal Rule. This 
revised draft guidance replaces the 2009 draft guidance for industry 
entitled ``Animal Models--Essential Elements to Address Efficacy Under 
the Animal Rule'' and addresses a broader scope of issues for products 
developed under the Animal Rule. Once finalized, this guidance is 
intended to help potential sponsors (industry, academia, and 
government) understand FDA's expectations for product development under 
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 
revised draft guidance before it begins work on the final version of 
the guidance, submit either electronic or written comments on the draft 
guidance by August 4, 2014.

ADDRESSES: Submit written requests for single copies of the revised 
draft guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Hillandale Building, rm. 4147, Silver Spring, MD 20993-
0002; or Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, rm. 3128, Silver Spring, MD 20993-
0022. Send one self-addressed adhesive label to assist that office in 
processing your requests. The revised draft guidance may also be 
obtained by mail by calling CBER at 1-800-835-4709 or 240-402-7800. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.
    Submit electronic comments on the revised draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Rosemary Roberts, Office of Counter-
Terrorism and Emergency Coordination, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, Mailstop 2163, Silver Spring, MD 20993-0002, 301-
796-2210; or Cynthia Kelley, Office of the Director, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, rm. 7204, Silver Spring, MD 20993-0002, 
240-402-8089.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 21, 2009 (74 FR 3610), FDA 
announced the availability of a draft guidance for industry entitled 
``Animal Models--Essential Elements to Address Efficacy Under the 
Animal Rule,'' which identified the critical characteristics (essential 
data elements) of an animal model to be addressed when developing drug 
or biological products for approval or licensure under the Animal Rule. 
The 2009 draft guidance is available to the public on FDA's Web site at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    This notice announces the availability of a revision to that draft 
guidance. The revised draft addresses a broader scope of issues for 
products developed under the Animal Rule. Based on written comments to 
the 2009 draft guidance and comments expressed at the related FDA 
public meeting held on November 5, 2010, FDA broadened the scope of the 
guidance to discuss product development under the Animal Rule. The 
revised draft guidance is intended to help potential sponsors 
understand FDA's expectations for product development under the Animal 
Rule.
    The revised draft guidance has been placed in a new category/
subject area, Animal Rule, and can be found under Guidances (Drugs) at 
the following Web link: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    New information addressing FDA's current thinking for studies 
related to the development of products under the Animal Rule is 
included in the revised draft guidance. Section III discusses 
regulatory considerations, including product development plans, access 
to investigational drugs during a public health emergency, 
communications with FDA, and animal model qualification program. 
General expectations for Animal Rule-specific studies are discussed in 
section IV, including a discussion of ensuring data quality and 
integrity. Additional information regarding the selection of an 
effective dose of the investigational drug for humans is discussed in 
section V. Design considerations for adequate and well-controlled 
efficacy studies in animals are described in section VI, which includes 
a discussion on general principles and dose selection in animals. 
Special considerations for vaccines and for cellular and gene therapies 
are outlined in sections VII.A and B, respectively. An additional 
checklist for the elements of an adequate and well-controlled animal 
efficacy study protocol is provided in section X. General principles 
for the care and use of animals in biomedical research and types of 
animal care interventions are explained in Appendices A and B, 
respectively. Finally, general expectations for natural history studies 
are described in Appendix C.
    This revised 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 product 
development 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. Paperwork Reduction Act

    This revised draft guidance refers to previously approved 
collections of information that are subject to review by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520). The collection of information in 21 CFR part 312 
(investigational new drug applications) has been approved under OMB 
control number 0910-0014. The collection of information in 21 CFR part 
314 (new drug applications) has been approved under OMB control number 
0910-0001. The collection of information resulting from special 
protocol assessments has been approved under OMB control number 0910-
0470. The collection of information resulting from formal meetings 
between applicants and FDA has been approved under OMB control number 
0910-0429. The collection of information resulting

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from Good Laboratory Practices has been approved under OMB control 
number 0910-0119. The collection of information resulting from current 
good manufacturing practices has been approved under OMB control number 
0910-0139.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

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

    Dated: May 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12807 Filed 6-2-14; 8:45 am]
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