S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines; International Council for Harmonisation; Draft Guidance for Industry; Availability, 1161-1163 [2019-00681]
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Federal Register / Vol. 84, No. 22 / Friday, February 1, 2019 / Notices
including each element of the strategy,
is meeting the goal or whether one or
more such goals or such elements
should be modified (section 505–1(g)(3)
of the FD&C Act). The statute does not
specifically describe how this
assessment should be conducted. Many
REMS include a goal related to
knowledge, such as to inform or educate
patients and healthcare providers about
the serious risks associated with and
safe use of a drug. When knowledge
goals are part of a REMS, the REMS
assessment plan generally includes, as
appropriate, an evaluation of patients’
and healthcare providers’ understanding
of the serious risk(s) associated with,
and safe use of, the drug.
The purpose of the REMS knowledge
assessment is to evaluate the target
populations’ knowledge about the
serious risk(s) and safe use of the drug.
Most applicants use surveys to evaluate
patients’ and healthcare providers’
understanding of the serious risk(s)
associated with, and safe use of, their
drugs to assess REMS knowledge goals.
This draft guidance, which describes
best practices for the design, conduct,
and data analyses of the results of REMS
assessment knowledge surveys to
evaluate patients’ and healthcare
providers’ understanding of the serious
risk(s) associated with, and safe use of,
a drug, incorporates input obtained from
the June 7, 2012, public workshop on
‘‘REMS Assessments: Social Science
Methodologies to Assess Goals Related
to Knowledge,’’ and the comments
submitted to the docket opened in
association with the workshop (FDA–
2012–N–0408).
This draft guidance is being issued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The draft guidance, when finalized, will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 conducting risk evaluation and
mitigation strategy assessment surveys
used to assess respondent knowledge of
REMS-related information. 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. Paperwork Reduction Act of 1995
This guidance refers to 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).
Elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of the draft guidance ‘‘REMS
Assessment: Planning and Reporting.’’
VerDate Sep<11>2014
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Jkt 247001
The assessment of burden hours
included in the NOA for the draft
guidance ‘‘REMS Assessment: Planning
and Reporting’’ includes the burden for
conducting knowledge surveys when
conducted in support of a REMS
Assessment.
III. Electronic Access
Persons with access to the internet
may obtain the document at https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, or https://
www.regulations.gov.
Dated: January 17, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019–00749 Filed 1–31–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–4524]
S11 Nonclinical Safety Testing in
Support of Development of Pediatric
Medicines; 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
guidance for industry entitled ‘‘S11
Nonclinical Safety Testing in Support of
Development of Pediatric Medicines.’’
The draft guidance was prepared under
the auspices of the International Council
for Harmonisation (ICH), formerly the
International Conference on
Harmonisation. The draft guidance
recommends international standards for
the nonclinical safety studies
recommended to support the
development of pediatric medicines.
Tissue engineered products, gene and
cellular therapies, and vaccines are
excluded from the scope of this
guidance. The guidance provides a
weight of evidence approach to
determine when nonclinical toxicity
studies may be recommended in
juvenile animals. If such studies are
recommended, the guidance provides
appropriate study designs. The draft
guidance is intended to promote
SUMMARY:
PO 00000
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Fmt 4703
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1161
harmonization of recommendations for
such studies and should facilitate the
timely conduct of pediatric clinical
trials and reduce the use of animals in
accordance with the 3Rs (replace/
reduce/refine) principles.
DATES: Submit either electronic or
written comments on the draft guidance
by April 2, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time 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, 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–
2018–D–4524 for ‘‘S11 Nonclinical
Safety Testing in Support of
Development of Pediatric Medicines.’’
Received comments will be placed in
E:\FR\FM\01FEN1.SGM
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1162
Federal Register / Vol. 84, No. 22 / Friday, February 1, 2019 / Notices
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff 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. 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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
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, 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,
VerDate Sep<11>2014
21:23 Jan 31, 2019
Jkt 247001
Rm. 3103, 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: Karen Davis
Bruno, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6428, Silver Spring,
MD 20993–0002, 301–796–1199; or
Mercedes Serabian, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 5313,
Silver Spring, MD 20993–0002, 240–
402–8349. Regarding the ICH: Amanda
Roache, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6364, Silver Spring,
MD 20993–0002, 301–796–4548.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, regulatory authorities
and industry associations from around
the world have participated in many
important initiatives to promote
international harmonization of
regulatory requirements under the ICH.
FDA has participated in several ICH
meetings designed to enhance
harmonization, and FDA 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 established 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; FDA; the Japanese
Ministry of Health, Labour, and Welfare;
the Japanese Pharmaceutical
Manufacturers Association; and the
Pharmaceutical Research and
Manufacturers of America. The
Standing Members of the ICH
Association include Health Canada and
PO 00000
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Fmt 4703
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Swissmedic. Any party eligible as 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. The Assembly
is responsible for the endorsement of
draft guidelines and adoption of final
guidelines. FDA publishes ICH
guidelines as FDA guidance.
In September 2018, the ICH Assembly
endorsed the draft guideline entitled
‘‘S11 Nonclinical Safety Testing in
Support of Development of Pediatric
Medicines’’ and agreed that the
guideline should be made available for
public comment. The draft guideline is
the product of the S11 Safety Expert
Working Group of the ICH. Comments
about this draft will be considered by
FDA and the S11 Safety Expert Working
Group.
The draft guidance describes a weight
of evidence approach to determine
when nonclinical toxicity studies may
be recommended in juvenile animals to
support development of medicines to be
used in pediatric patients. If such
studies are recommended, the draft
guidance also provides appropriate
study designs. The draft guidance
describes study designs as consisting of
a core set of endpoints that can be
supplemented by additional endpoints
depending on the concerns identified in
the weight of evidence approach. The
draft guidance also provides guidance
on potential approaches for the
nonclinical support of drugs that will be
developed only for use in pediatric
patients or that will be first tested in
pediatric patients. The draft guidance is
intended to promote harmonization of
recommendations for such studies and
should facilitate the timely conduct of
pediatric clinical trials and reduce the
use of animals in accordance with the
3Rs (replace/reduce/refine) principles.
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 ‘‘Nonclinical Safety Testing in
Support of Development of Pediatric
Medicines.’’ 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
E:\FR\FM\01FEN1.SGM
01FEN1
Federal Register / Vol. 84, No. 22 / Friday, February 1, 2019 / Notices
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: January 16, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019–00681 Filed 1–31–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0539]
Immunogenicity Testing of Therapeutic
Protein Products—Developing and
Validating Assays for Anti-Drug
Antibody Detection; 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 final
guidance for industry entitled
‘‘Immunogenicity Testing of
Therapeutic Protein Products—
Developing and Validating Assays for
Anti-Drug Antibody Detection.’’ This
guidance provides recommendations to
facilitate industry’s development and
validation of assays for assessment of
the immunogenicity of therapeutic
protein products during clinical trials.
The guidance applies to assays for the
detection of anti-drug antibodies (ADAs)
and may also apply to some peptides,
oligonucleotides, and combination
products on a case-by-case basis. The
guidance includes recommendations
regarding the development and
validation of screening assays,
confirmatory assays, titration assays,
and neutralization assays. This guidance
finalizes the revised draft guidance for
industry entitled ‘‘Assay Development
and Validation for Immunogenicity
Testing of Therapeutic Protein
Products’’ issued in April 2016 and
includes a revised title.
SUMMARY:
VerDate Sep<11>2014
21:23 Jan 31, 2019
Jkt 247001
The announcement of the
guidance is published in the Federal
Register on February 1, 2019.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
DATES:
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, 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–
2009–D–0539 for ‘‘Immunogenicity
Testing of Therapeutic Protein
Products—Developing and Validating
Assays for Anti-Drug Antibody
Detection.’’ 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 between 9
a.m. and 4 p.m., Monday through
Friday.
PO 00000
Frm 00117
Fmt 4703
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1163
• 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. 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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
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, 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,
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. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
E:\FR\FM\01FEN1.SGM
01FEN1
]]>Agencies
[Federal Register Volume 84, Number 22 (Friday, February 1, 2019)]
[Notices]
[Pages 1161-1163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00681]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-4524]
S11 Nonclinical Safety Testing in Support of Development of
Pediatric Medicines; 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 for industry entitled ``S11
Nonclinical Safety Testing in Support of Development of Pediatric
Medicines.'' The draft guidance was prepared under the auspices of the
International Council for Harmonisation (ICH), formerly the
International Conference on Harmonisation. The draft guidance
recommends international standards for the nonclinical safety studies
recommended to support the development of pediatric medicines. Tissue
engineered products, gene and cellular therapies, and vaccines are
excluded from the scope of this guidance. The guidance provides a
weight of evidence approach to determine when nonclinical toxicity
studies may be recommended in juvenile animals. If such studies are
recommended, the guidance provides appropriate study designs. The draft
guidance is intended to promote harmonization of recommendations for
such studies and should facilitate the timely conduct of pediatric
clinical trials and reduce the use of animals in accordance with the
3Rs (replace/reduce/refine) principles.
DATES: Submit either electronic or written comments on the draft
guidance by April 2, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time 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, 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-2018-D-4524 for ``S11 Nonclinical Safety Testing in Support of
Development of Pediatric Medicines.'' Received comments will be placed
in
[[Page 1162]]
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff 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. 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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, 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. 3103, 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: Karen Davis
Bruno, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6428, Silver
Spring, MD 20993-0002, 301-796-1199; or Mercedes Serabian, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 5313, Silver Spring, MD 20993-0002,
240-402-8349. Regarding the ICH: Amanda Roache, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6364, Silver Spring, MD 20993-0002, 301-
796-4548.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, regulatory authorities and industry associations
from around the world have participated in many important initiatives
to promote international harmonization of regulatory requirements under
the ICH. FDA has participated in several ICH meetings designed to
enhance harmonization, and FDA 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 established 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; FDA; the Japanese Ministry
of Health, Labour, and Welfare; the Japanese Pharmaceutical
Manufacturers Association; and the Pharmaceutical Research and
Manufacturers of America. The Standing Members of the ICH Association
include Health Canada and Swissmedic. Any party eligible as 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.
The Assembly is responsible for the endorsement of draft guidelines and
adoption of final guidelines. FDA publishes ICH guidelines as FDA
guidance.
In September 2018, the ICH Assembly endorsed the draft guideline
entitled ``S11 Nonclinical Safety Testing in Support of Development of
Pediatric Medicines'' and agreed that the guideline should be made
available for public comment. The draft guideline is the product of the
S11 Safety Expert Working Group of the ICH. Comments about this draft
will be considered by FDA and the S11 Safety Expert Working Group.
The draft guidance describes a weight of evidence approach to
determine when nonclinical toxicity studies may be recommended in
juvenile animals to support development of medicines to be used in
pediatric patients. If such studies are recommended, the draft guidance
also provides appropriate study designs. The draft guidance describes
study designs as consisting of a core set of endpoints that can be
supplemented by additional endpoints depending on the concerns
identified in the weight of evidence approach. The draft guidance also
provides guidance on potential approaches for the nonclinical support
of drugs that will be developed only for use in pediatric patients or
that will be first tested in pediatric patients. The draft guidance is
intended to promote harmonization of recommendations for such studies
and should facilitate the timely conduct of pediatric clinical trials
and reduce the use of animals in accordance with the 3Rs (replace/
reduce/refine) principles.
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 ``Nonclinical
Safety Testing in Support of Development of Pediatric Medicines.'' 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
[[Page 1163]]
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: January 16, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-00681 Filed 1-31-19; 8:45 am]
BILLING CODE 4164-01-P
