[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Pages 54295-54296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22683]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1039]


Nonclinical Evaluation of Endocrine-Related Drug Toxicity; 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Nonclinical 
Evaluation of Endocrine-Related Drug Toxicity.'' The purpose of this 
guidance is to clarify when additional studies are warranted after the 
standard toxicology tests have been conducted and there is a signal for 
potential adverse endocrine-related toxicity. This guidance finalizes 
the draft guidance entitled ``Endocrine Disruption Potential of Drugs: 
Nonclinical Evaluation'' issued on September 20, 2013.

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

ADDRESSES: 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. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    Submit electronic comments on the 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: Abby Jacobs, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg., 22, Rm. 6474, Silver Spring, MD 20993-0002, 301-
796-0174.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Nonclinical Evaluation of Endocrine-Related Drug Toxicity.'' 
This guidance focuses on nonclinical testing designed to assess the 
potential for a drug to cause endocrine effects that are

[[Page 54296]]

unintentional and adverse. The standard comprehensive test battery is 
generally sufficient to identify endocrine-related toxicity. Depending 
on the outcome of a standard battery of nonclinical tests, additional 
nonclinical studies may be warranted to more fully characterize the 
endocrine-related toxicity potential of a drug.
    This guidance finalizes the draft guidance entitled ``Endocrine 
Disruption Potential of Drugs: Nonclinical Evaluation'' issued on 
September 20, 2013 (78 FR 57859). Revisions to the draft guidance 
address public comments and try to give more clarity regarding when 
additional studies could be appropriate.
    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 nonclinical evaluation of endocrine-related 
drug toxicity. 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. The Paperwork Reduction Act of 1995

    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 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312 and 314 have 
been approved under OMB control numbers 0910-0014 and 0910-0001, 
respectively.

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 or http://www.regulations.gov.

    Dated: September 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22683 Filed 9-8-15; 8:45 am]
 BILLING CODE 4164-01-P