Document ID: FDA-2013-D-1039-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry on Endocrine Disruption Potential of Drugs:  Nonclinical Evaluation; Availability
Posted Date: 2013-09-20T04:00Z

[Federal Register Volume 78, Number 183 (Friday, September 20, 2013)]
[Notices]
[Pages 57859-57860]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22864]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Draft Guidance for Industry on Endocrine Disruption Potential of 
Drugs: Nonclinical Evaluation; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Endocrine 
Disruption Potential of Drugs: Nonclinical Evaluation.'' This draft 
guidance provides recommendations to sponsors on the parameters that 
should be routinely assessed in toxicology studies for investigational 
new drug applications (INDs), new drug applications (NDAs), and 
biologics license applications (BLAs) regulated by the Center for Drug 
Evaluation and Research to determine the potential for a drug to 
disrupt the endocrine system. This draft guidance also discusses 
factors to consider in determining the need for additional studies to 
characterize potential endocrine disruptor properties of a drug.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 19, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: David Jacobson-Kram, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6488, Silver Spring, MD 20993-0002, 301-
796-0175.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Endocrine Disruption Potential of Drugs: Nonclinical 
Evaluation.'' Endocrine disruptors are compounds that have the 
potential to interfere with some aspect of the endocrine system of an 
organism or its progeny. Any component of the endocrine system can be a 
target of endocrine disruptors, although the systems most commonly 
affected include the sex hormones (e.g., estrogen and androgen), the 
hypothalamic-pituitary-adrenal axis, the thyroid hormone, and the 
hormones involved in the feedback regulation of those components (e.g., 
gonadotropin releasing hormone and corticotropin). Changes in endocrine 
function can result in transgenerational effects (e.g., through 
epigenetic mechanisms). Epigenetic modifications are heritable changes 
in gene function that occur in the absence of changes to the nucleotide 
sequence. Because such changes can be maintained and transmitted 
through the germ cells, these modifications can affect gene actions 
across generations.
    This draft guidance provides recommendations to sponsors on the

[[Page 57860]]

parameters that should be routinely assessed in toxicology studies for 
INDs, NDAs, and BLAs that are designed to determine the potential for a 
drug to disrupt the endocrine system. This draft guidance also 
discusses factors that should be considered in determining the need for 
additional studies to characterize potential endocrine disruptor 
properties of a drug.
    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 nonclinical 
evaluation of endocrine disruption potential of drugs. 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 of 1995

    This 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 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 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22864 Filed 9-19-13; 8:45 am]
BILLING CODE 4160-01-P