[Federal Register Volume 76, Number 185 (Friday, September 23, 2011)]
[Notices]
[Page 59142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-24431]



[[Page 59142]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1999-N-0082 (Formerly Docket No. 1999N-2079)]


Guidance for Industry on Reproductive and Developmental 
Toxicities--Integrating Study Results To Assess Concerns; 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 guidance for industry entitled ``Reproductive and 
Developmental Toxicities--Integrating Study Results to Assess 
Concerns.'' This guidance describes an approach to estimating possible 
human developmental or reproductive risks associated with drug or 
biological product exposure when a nonclinical finding of toxicity has 
been identified, but definitive human data are unavailable. The 
guidance is intended for drug developers planning to submit new drug 
applications (NDAs) and biologics licensing applications (BLAs), and 
who are assessing nonclinical toxicity information.

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, 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 
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:  Abigail Jacobs, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg 22, Rm. 6484, Silver Spring, MD 20993-0002, 301-
796-0174.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance entitled 
``Reproductive and Developmental Toxicities--Integrating Study Results 
to Assess Concerns.'' This guidance describes an approach to estimating 
possible human developmental or reproductive risks associated with drug 
or biological product exposure when a finding of toxicity has been 
identified, but definitive human data are unavailable. The guidance is 
intended for drug developers intending to submit NDAs and BLAs, and who 
are assessing nonclinical toxicity information. The recommendations 
included here will also help to ensure a consistent review of 
reproductive and developmental toxicity data among Center for Drug 
Evaluation and Research review staff.
    This guidance does not: (1) Give detailed advice about labeling or 
placement of toxicity information in product labeling (for information 
on labeling, see 21 CFR 201.57); or (2) discuss clinical data, the 
integration of nonclinical and clinical data, or the clinical 
implications of these data.
    The approach presented here for assessing nonclinical reproductive 
and developmental toxicity data involves the integration and careful 
consideration of a variety of different types of nonclinical 
information: Reproductive toxicology; general toxicology; and 
toxicokinetic and pharmacokinetic information, including absorption, 
distribution, metabolism, and elimination findings. The approach is 
used when there is a toxicity finding and focuses on assessing the 
likelihood that a drug will increase the risk of adverse human 
developmental or reproductive outcomes. The approach includes noting 
when studies were not conducted or when they were not performed using 
relevant model systems or at appropriate dose ranges.
    On November 13, 2001 (66 FR 56830), FDA issued a draft of this 
guidance. Comments were received and carefully considered during the 
finalization of the guidance. Most changes to the document are 
editorial. However, one important change has been made. The description 
of a process that involved assignment of values of +1, -1 or 0 to the 
various factors was removed from the guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on integration of study results to assess 
concerns about human reproductive and developmental toxicities. 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. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

III. 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 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-24431 Filed 9-22-11; 8:45 am]
BILLING CODE 4160-01-P