80 FR 66011 - Product Development Under the Animal Rule; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 208 (October 28, 2015)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Product Development Under the Animal Rule.'' When human efficacy studies are not ethical and field trials are not 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 This guidance finalizes the 2014 revised draft guidance for industry ``Product Development Under the Animal Rule.'' It is intended to help potential stakeholders (industry, academia, and government) understand FDA's expectations for product development under the Animal Rule.

[Federal Register Volume 80, Number 208 (Wednesday, October 28, 2015)]
[Notices]
[Pages 66011-66013]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27361]


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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; Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Product 
Development Under the Animal Rule.'' When human efficacy studies are 
not ethical and field trials are not 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 
guidance finalizes the 2014 revised draft guidance for industry 
``Product Development Under the Animal Rule.'' It is intended to help 
potential stakeholders (industry, academia, and government) understand 
FDA's expectations for product development under the Animal Rule.

[[Page 66012]]


DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2009-D-0007 for ``Product Development Under the Animal Rule; 
Guidance for Industry; Availability.'' Received comments will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002; or Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. This guidance may also be obtained by mail by calling 
CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Rosemary Roberts, Counter-Terrorism 
and Emergency Coordination Staff, Office of the Center Director, Center 
for Drug Evaluation and Research, Food and Drug Administration, 10001 
New Hampshire Ave., Hillandale Building, Rm. 2155, 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

    FDA is announcing the availability of a guidance for industry 
entitled ``Product Development Under the Animal Rule.'' In the Federal 
Register of June 3, 2014 (79 FR 31950), FDA announced the availability 
of a revised draft guidance for industry entitled ``Product Development 
Under the Animal Rule,'' intended to help potential stakeholders 
understand FDA's expectations for product development under the Animal 
Rule (see 21 CFR 314.600 through 314.650 for drugs and 21 CFR 601.90 
through 601.95 for biological products). The 2014 revised draft 
guidance replaced the 2009 draft guidance for industry entitled 
``Animal Models--Essential Elements to Address Efficacy Under the 
Animal Rule'' (74 FR 3610) and addressed a broader scope of issues for 
products developed under the Animal Rule. The comment period for the 
revised draft guidance closed on August 4, 2014. We reviewed all 
comments received and considered them in finalizing the revised draft 
guidance. This guidance finalizes the revised draft guidance issued on 
June 3, 2014.\1\
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    \1\ Adequate and well-controlled animal efficacy studies are 
required under the Animal Rule. As a policy, FDA is committed to the 
exploration of non-animal testing methods.
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    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on product development under the Animal Rule. 
It does not establish any rights for any person and is not binding on 
FDA or the public. You can use an alternative approach if it satisfies 
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act

    This 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

[[Page 66013]]

(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 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. Electronic Access

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

    Dated: October 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27361 Filed 10-27-15; 8:45 am]
 BILLING CODE 4164-01-P