Guidance for Industry on Reproductive and Developmental Toxicities-Integrating Study Results To Assess Concerns; Availability, 59142 [2011-24431]
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59142
Federal Register / Vol. 76, No. 185 / Friday, September 23, 2011 / Notices
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.
sroberts on DSK5SPTVN1PROD with NOTICES
ACTION:
Notice.
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 https://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
VerDate Mar<15>2010
16:41 Sep 22, 2011
Jkt 223001
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
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
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
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Joint Meeting of the Advisory
Committee for Reproductive Health
Drugs and the Drug Safety and Risk
Management Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committees: Advisory
Committee for Reproductive Health
Drugs and the Drug Safety and Risk
Management Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 9, 2011, from 8 a.m.
to 5 p.m.
Location: The Marriott Inn and
Conference Center, University of
Maryland University College (UMUC),
The Ballroom, 3501 University Blvd.,
E:\FR\FM\23SEN1.SGM
23SEN1
]]>Agencies
[Federal Register Volume 76, Number 185 (Friday, September 23, 2011)]
[Notices]
[Page 59142]
From the Federal Register Online via the Government Printing 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.
-----------------------------------------------------------------------
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 https://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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://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
