[Federal Register Volume 78, Number 183 (Friday, September 20, 2013)]
[Notices]
[Pages 57859-57860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22864]
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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Draft Guidance for Industry on Endocrine Disruption Potential of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.
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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availability of a draft guidance for industry entitled ``Endocrine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 This draft
guidance provides recommendations to sponsors on the parameters that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 This draft guidance also discusses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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 19, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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]
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