S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals; International Council for Harmonisation; Draft Guidance for Industry; Availability, 52306-52308 [2017-24483]
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52306
Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices
Under the
PRA (44 U.S.C. 3501–3520), federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval.
To comply with the above
requirement, ACL is publishing a notice
of a new collection of information as set
forth in this document. With respect to
the following collection of information,
ACL invites comments on: (1) Whether
the proposed collection of information
is necessary for the proper performance
of ACL’s functions, including whether
the information will have practical
utility and/or help ACL illustrate the
program’s return on investment; (2) the
accuracy of ACL’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
SUPPLEMENTARY INFORMATION:
on respondents, including through the
use of automated collection techniques
when appropriate and other forms of
information technology.
Purpose
The purpose of the Traumatic Brain
Injury (TBI) State Partnership program
is to increase access to rehabilitation
and other services for individuals with
traumatic brain injury. Under the
Traumatic Brain Injury Reauthorization
Act of 2014 (Pub. L. 113–196), the
Traumatic Brain Injury State
Partnership program transitioned from
the Health Resources and Services
Administration (HRSA) to the
Administration for Community Living
(ACL). Under this law, the Secretary,
acting through ACL, was authorized to
‘‘make grants to States and American
Indian consortia for the purpose of
carrying out projects to improve access
to rehabilitation and other services
regarding traumatic brain injury.’’ ACL
seeks to collect performance measure
data from state grantees consistent with
the TBI State Partnership program’s
purpose and ACL’s mission to
‘‘Maximize the independence, wellbeing, and health of older adults, people
with disabilities across the lifespan, and
their families and caregivers.’’
ACL seeks data on a semi-annual
basis on the types of practices,
protocols, and activities performed by
each grantee, as well as the cost of each
activity and the number and types of
people they served. ACL also seeks
Number of
respondents
Type of respondent
Form name
States ............................
State Performance Report ...................................
information about the number and types
of individuals who receive TBI-related
home and community based services.
Finally, ACL seeks information
regarding the involvement of people
with TBI in advisory and program
support roles.
The data collected will allow ACL to
determine the extent to which the grant
program is meeting its goals of
expanding and improving services,
generating sustainable funding streams,
and enriching service systems to better
serve individuals with TBI and their
families. The data will also help ACL
develop and expand baseline
information around the nature and
scope of the incidence of TBI.
Additionally, this data collection will
help ACL illustrate the return on
investment of the TBI funds in terms of
system change (i.e., changes in policies
and practices and the development of
networks). By matching the project
dollars spent against measurable
improvements in state systems for
delivering services and supports to
people living with TBI, ACL will have
a strong indicator of the effect of the TBI
program on the quality of services
which ultimately impact the lives of
people across the country living with
TBI. The proposed data collection forms
may be found on the ACL Web site for
review at: https://www.acl.gov/aboutacl/public-input.
Estimated Program Burden: The
annual reporting burden estimates are
shown below.
Number of
responses per
respondent
* 45
2
Average
burden per
response
(in hours)
16
Total
burden hours
1,440
* This is the highest number of awards anticipated, but it is possible that there will be less. If less than 45 grants are awarded, the total burden
hours will be adjusted proportionally.
Dated: November 7, 2017.
Mary Lazare,
Principal Deputy Administrator.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–24525 Filed 11–9–17; 8:45 am]
asabaliauskas on DSKBBXCHB2PROD with NOTICES
BILLING CODE 4154–01–P
Food and Drug Administration
[Docket No. FDA–2017–D–5138]
S5(R3) Detection of Toxicity to
Reproduction for Human
Pharmaceuticals; International Council
for Harmonisation; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
SUMMARY:
VerDate Sep<11>2014
18:38 Nov 09, 2017
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guidance entitled ‘‘S5(R3) Detection of
Toxicity to Reproduction for Human
Pharmaceuticals.’’ The draft guidance
was prepared under the auspices of the
International Council for Harmonisation
(ICH), formerly the International
Conference on Harmonisation. The draft
guidance replaces the existing guidance
entitled ‘‘S5(R2) Detection of Toxicity to
Reproduction for Human
Pharmaceuticals.’’ The draft guidance is
intended to align with other ICH
guidances, elaborate on concepts to
consider when designing studies, and
identify potential circumstances in
which a risk assessment can be made
based on preliminary studies. It also
clarifies the qualification and potential
use of alternative assays.
E:\FR\FM\13NON1.SGM
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Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices
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 February 12,
2018.
DATES:
ADDRESSES:
You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff Office, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–D–5138 for ‘‘S5(R3) Detection of
Toxicity to Reproduction for Human
Pharmaceuticals.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
VerDate Sep<11>2014
18:38 Nov 09, 2017
Jkt 244001
https://www.regulations.gov or at the
Dockets Management Staff Office
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff Office. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
Submit written requests for single
copies of this draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research (CDER),
Food and Drug Administration, 10001
New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD
20993–0002, or the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. The guidance may also be
PO 00000
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52307
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Abigail 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; or
Martin (Dave) Green, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3270, Silver Spring, MD 20993–0002,
301–796–2640. Regarding the ICH:
Amanda Roache, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1176,
Silver Spring, MD 20993–0002, 301–
796–4548.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘S5(R3) Detection of Toxicity to
Reproduction for Human
Pharmaceuticals.’’ In recent years,
regulatory authorities and industry
associations have participated in many
important initiatives to promote
international harmonization of
regulatory requirements. FDA has
participated in several meetings
designed to enhance harmonization and
is committed to seeking scientifically
based, harmonized technical procedures
for pharmaceutical development. One of
the goals of harmonization is to identify
and reduce differences in technical
requirements for drug development
among regulatory agencies.
ICH was organized to provide an
opportunity for harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products for human use
among regulators around the world. The
six founding members of the ICH are the
European Commission; the European
Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of
Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers
Association; CDER and CBER, FDA; and
the Pharmaceutical Research and
Manufacturers of America. The
Standing Members of the ICH
Association include Health Canada and
E:\FR\FM\13NON1.SGM
13NON1
asabaliauskas on DSKBBXCHB2PROD with NOTICES
52308
Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices
Swissmedic. Any party eligible to
become a member in accordance with
the ICH Articles of Association can
apply for membership in writing to the
ICH Secretariat. The ICH Secretariat,
which coordinates the preparation of
documentation, operates as an
international nonprofit organization and
is funded by the members of the ICH
Association.
The ICH Assembly is the overarching
body of the Association and includes
representatives from each of the ICH
members and observers.
In August 2017, the ICH Assembly
endorsed the draft guidance titled
‘‘S5(R3) Detection of Toxicity to
Reproduction for Human
Pharmaceuticals’’ and agreed that the
guidance should be made available for
public comment. The draft guidance is
the product of the S5(R3) Safety Expert
Working Group of the ICH. Comments
about this draft will be considered by
FDA and the S5(R3) Safety Expert
Working Group.
The draft guidance replaces the
existing guidance entitled ‘‘S5(R2)
Detection of Toxicity to Reproduction
for Human Pharmaceuticals.’’ The
guidance has undergone major revisions
to align with other ICH guidances,
elaborate on concepts to consider when
designing studies, and identify potential
circumstances in which a risk
assessment can be made based on
preliminary studies. It also clarifies the
qualification and potential use of
alternative assays.
To support using alternative assays,
compounds that are either positive or
negative in their ability to induce
embryolethality or malformations are
used in the process of qualifying the
assays. Although a number of
compounds have been identified in the
draft guidance’s Annex, section 11.3.4,
Tables 9–6 and 9–7, with the type of
information for the compounds, the list
is not complete; therefore, FDA is
requesting data in the form of public
comments to the docket for additional
positive and negative reference
compounds for potential inclusion into
the list. These compounds can be either
pharmaceuticals or nonpharmaceuticals and should be
commercially available. For additional
guidance, please refer to Endnote 3 in
the S5(R3) guidance. This is not a
request for data for the compounds
already listed in Table 9–6, nor is this
a request for examples of assays that
could be used.
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 current thinking of FDA
VerDate Sep<11>2014
18:38 Nov 09, 2017
Jkt 244001
on ‘‘S5(R3) Detection of Toxicity to
Reproduction for Human
Pharmaceuticals.’’ 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. This guidance
is not subject to Executive Order 12866.
II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.regulations.gov, https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, or https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm.
Dated: November 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–24483 Filed 11–9–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Voluntary
Partner Surveys To Implement
Executive Order 12862 in the Health
Resources and Services
Administration, OMB No. 0915–0212—
Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR must be
received no later than January 12, 2018.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
SUMMARY:
PO 00000
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Officer, 14N39, 5600 Fishers Lane,
Rockville, MD 20857.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference, in compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995.
Information Collection Request Title:
Voluntary Partner Surveys to Implement
Executive Order 12862 in the Health
Resources and Services Administration
OMB No. 0915–0212—Extension.
Abstract: In response to Executive
Order 12862, HRSA is proposing to
conduct voluntary customer surveys of
its partners to assess strengths and
weaknesses in program services and
processes. HRSA partners are typically
state or local governments, health care
facilities, health care consortia, health
care providers, and researchers. HRSA
is requesting continued approval for a
generic clearance from OMB to conduct
the partner surveys.
Partner surveys to be conducted by
HRSA might include, for example, mail
or telephone surveys of grantees to
determine satisfaction with grant
processes or technical assistance
provided by a contractor, or in-class
evaluation forms completed by
providers who receive training from
HRSA grantees to measure satisfaction
with the training experience. HRSA will
use the results of these surveys to plan
and redirect resources and efforts as
needed to improve services and
processes.
HRSA may also use focus groups to
gain partner input into the design of
mail and telephone surveys. Focus
groups, in-class evaluation forms, mail
surveys, and telephone surveys are
expected to be the preferred data
collection methods.
A generic approval allows HRSA to
conduct a limited number of partner
surveys without a full-scale OMB
review of each survey. If this request
receives continued approval,
information on each individual partner
survey will not be published in the
Federal Register.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\13NON1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 217 (Monday, November 13, 2017)]
[Notices]
[Pages 52306-52308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24483]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-5138]
S5(R3) Detection of Toxicity to Reproduction for Human
Pharmaceuticals; International Council for Harmonisation; Draft
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance entitled ``S5(R3) Detection of
Toxicity to Reproduction for Human Pharmaceuticals.'' The draft
guidance was prepared under the auspices of the International Council
for Harmonisation (ICH), formerly the International Conference on
Harmonisation. The draft guidance replaces the existing guidance
entitled ``S5(R2) Detection of Toxicity to Reproduction for Human
Pharmaceuticals.'' The draft guidance is intended to align with other
ICH guidances, elaborate on concepts to consider when designing
studies, and identify potential circumstances in which a risk
assessment can be made based on preliminary studies. It also clarifies
the qualification and potential use of alternative assays.
[[Page 52307]]
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 February 12, 2018.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff Office, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2017-D-5138 for ``S5(R3) Detection of Toxicity to Reproduction for
Human Pharmaceuticals.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff Office between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff Office. If you do
not wish your name and contact information to be made publicly
available, you can provide this information on the cover sheet and not
in the body of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of this draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research (CDER), Food and Drug Administration, 10001 New Hampshire
Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your requests. The guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Abigail
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; or Martin (Dave) Green, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3270, Silver Spring, MD 20993-0002,
301-796-2640. Regarding the ICH: Amanda Roache, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993-0002, 301-
796-4548.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``S5(R3) Detection of Toxicity to Reproduction for Human
Pharmaceuticals.'' In recent years, regulatory authorities and industry
associations have participated in many important initiatives to promote
international harmonization of regulatory requirements. FDA has
participated in several meetings designed to enhance harmonization and
is committed to seeking scientifically based, harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and reduce differences in technical
requirements for drug development among regulatory agencies.
ICH was organized to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. FDA also seeks input from consumer
representatives and others. ICH is concerned with harmonization of
technical requirements for the registration of pharmaceutical products
for human use among regulators around the world. The six founding
members of the ICH are the European Commission; the European Federation
of Pharmaceutical Industries Associations; the Japanese Ministry of
Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers
Association; CDER and CBER, FDA; and the Pharmaceutical Research and
Manufacturers of America. The Standing Members of the ICH Association
include Health Canada and
[[Page 52308]]
Swissmedic. Any party eligible to become a member in accordance with
the ICH Articles of Association can apply for membership in writing to
the ICH Secretariat. The ICH Secretariat, which coordinates the
preparation of documentation, operates as an international nonprofit
organization and is funded by the members of the ICH Association.
The ICH Assembly is the overarching body of the Association and
includes representatives from each of the ICH members and observers.
In August 2017, the ICH Assembly endorsed the draft guidance titled
``S5(R3) Detection of Toxicity to Reproduction for Human
Pharmaceuticals'' and agreed that the guidance should be made available
for public comment. The draft guidance is the product of the S5(R3)
Safety Expert Working Group of the ICH. Comments about this draft will
be considered by FDA and the S5(R3) Safety Expert Working Group.
The draft guidance replaces the existing guidance entitled ``S5(R2)
Detection of Toxicity to Reproduction for Human Pharmaceuticals.'' The
guidance has undergone major revisions to align with other ICH
guidances, elaborate on concepts to consider when designing studies,
and identify potential circumstances in which a risk assessment can be
made based on preliminary studies. It also clarifies the qualification
and potential use of alternative assays.
To support using alternative assays, compounds that are either
positive or negative in their ability to induce embryolethality or
malformations are used in the process of qualifying the assays.
Although a number of compounds have been identified in the draft
guidance's Annex, section 11.3.4, Tables 9-6 and 9-7, with the type of
information for the compounds, the list is not complete; therefore, FDA
is requesting data in the form of public comments to the docket for
additional positive and negative reference compounds for potential
inclusion into the list. These compounds can be either pharmaceuticals
or non-pharmaceuticals and should be commercially available. For
additional guidance, please refer to Endnote 3 in the S5(R3) guidance.
This is not a request for data for the compounds already listed in
Table 9-6, nor is this a request for examples of assays that could be
used.
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 current thinking of FDA on ``S5(R3)
Detection of Toxicity to Reproduction for Human Pharmaceuticals.'' 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. This guidance
is not subject to Executive Order 12866.
II. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
Dated: November 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24483 Filed 11-9-17; 8:45 am]
BILLING CODE 4164-01-P
