S11 Nonclinical Safety Testing in Support of Development of Pediatric Pharmaceuticals; International Council for Harmonisation; Guidance for Industry; Availability, 26056-26058 [2021-09964]
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Federal Register / Vol. 86, No. 90 / Wednesday, May 12, 2021 / Notices
can support the waiver of the in vivo BE
requirement for certain drug products.
Following the public consultation
period, clarifications were made to the
guidance based on the comments
received.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘M9
Biopharmaceutics Classification
System-Based Biowaivers.’’ 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.
khammond on DSKJM1Z7X2PROD with NOTICES
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required. However, this
final guidance refers to previously
approved FDA collections of
information. The previously approved
collections of information are subject to
review by OMB under the PRA. The
following collections of information
have been approved under OMB control
number 0910–0001:
• Submitting under 21 CFR 314.50
content and format of new drug
applications, including the
pharmacokinetics and bioavailability
sections.
• Submitting under 21 CFR 314.70
postapproval changes.
• Submitting under 21 CFR 314.94
content and format of abbreviated new
drug applications.
The collections of information for
submitting under 21 CFR 312.23
information about pharmacokinetics
and biological disposition of the drug
has been approved under OMB control
number 0910–0014.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.regulations.gov, https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm.
Dated: May 6, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–09962 Filed 5–11–21; 8:45 am]
BILLING CODE 4164–01–P
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17:58 May 11, 2021
Jkt 253001
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
Pharmaceuticals; International Council
for Harmonisation; 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 ‘‘S11
Nonclinical Safety Testing in Support of
Development of Pediatric
Pharmaceuticals.’’ The guidance was
prepared under the auspices of the
International Council for Harmonisation
of Technical Requirements for
Registration of Pharmaceuticals for
Human Use (ICH), formerly the
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use. The
guidance recommends international
standards for the nonclinical safety
studies recommended to support the
development of pediatric medicines.
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 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
3R (replace/reduce/refine) principles.
Tissue engineered products, gene and
cellular therapies, and vaccines are
excluded from the scope of this
guidance. The guidance replaces the
draft guidance issued on February 1,
2019.
SUMMARY:
The announcement of the
guidance is published in the Federal
Register on May 12, 2021.
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
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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
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 between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• 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
E:\FR\FM\12MYN1.SGM
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Federal Register / Vol. 86, No. 90 / Wednesday, May 12, 2021 / Notices
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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
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. 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 guidance
document.
khammond on DSKJM1Z7X2PROD with NOTICES
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,
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
VerDate Sep<11>2014
17:58 May 11, 2021
Jkt 253001
Silver Spring, MD 20993–0002, 240–
402–7911.
Regarding the ICH: Jill Adleberg,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6364, Silver Spring,
MD 20993–0002, 301–796–5259,
Jill.Adleberg@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘S11
Nonclinical Safety Testing in Support of
Development of Pediatric
Pharmaceuticals.’’ The guidance was
prepared under the auspices of ICH. ICH
has the mission of achieving greater
regulatory harmonization worldwide to
ensure that safe, effective, high-quality
medicines are developed, registered,
and maintained in the most resourceefficient manner. By harmonizing the
regulatory requirements in regions
around the world, ICH guidelines have
substantially reduced duplicative
clinical studies, prevented unnecessary
animal studies, standardized the
reporting of important safety
information, standardized marketing
application submissions, and made
many other improvements in the quality
of global drug development and
manufacturing and the products
available to patients.
The six Founding Members of the ICH
are FDA; the Pharmaceutical Research
and Manufacturers of America; the
European Commission; the European
Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of
Health, Labour, and Welfare; and the
Japanese Pharmaceutical Manufacturers
Association. The Standing Members of
the ICH Association include Health
Canada and Swissmedic. Additionally,
the Membership of ICH has expanded to
include other regulatory authorities and
industry associations from around the
world (refer to https://www.ich.org/).
ICH works by involving technical
experts from both regulators and
industry parties in detailed technical
harmonization work and the application
of a science-based approach to
harmonization through a consensusdriven process that results in the
development of ICH guidelines. The
regulators around the world are
committed to consistently adopting
these consensus-based guidelines,
realizing the benefits for patients and for
industry.
As a Founding Regulatory Member of
ICH, FDA plays a major role in the
development of each of the ICH
guidelines, which FDA then adopts and
issues as guidance for industry. FDA’s
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26057
guidance documents do not establish
legally enforceable responsibilities.
Instead, they describe the Agency’s
current thinking on a topic and should
be viewed only as recommendations,
unless specific regulatory or statutory
requirements are cited. In the Federal
Register of February 1, 2019 (84 FR
1161), FDA published a notice
announcing the availability of a draft
guidance entitled ‘‘S11 Nonclinical
Safety Testing in Support of
Development of Pediatric Medicines.’’
The notice gave interested persons an
opportunity to submit comments by
April 2, 2019. After consideration of the
comments received and revisions to the
guideline, a final draft of the guideline
was submitted to the ICH Assembly and
endorsed by the regulatory agencies in
April 2020.
This guidance finalizes the draft
guidance issued on February 1, 2019.
The 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 guidance
also provides appropriate study designs.
The 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 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
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 3R (replace/reduce/
refine) principles.
The draft guidance was revised based
on comments received. The revisions
include refinement of the weight of
evidence approach and in descriptions
of the core and additional endpoints
that can be incorporated into juvenile
animal studies. The final guidance also
includes a new section on data
interpretation. The appendices on agedependent development of organ
systems by species and preweaning
litter allocation in the rodent were also
updated. Additionally, the title of the
guidance was updated from
‘‘Nonclinical Safety Testing in Support
of Development of Pediatric Medicines’’
to ‘‘Nonclinical Safety Testing in
Support of Development of Pediatric
Pharmaceuticals.’’
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Federal Register / Vol. 86, No. 90 / Wednesday, May 12, 2021 / Notices
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘S11 Nonclinical
Safety Testing in Support of
Development of Pediatric
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.
khammond on DSKJM1Z7X2PROD with NOTICES
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 312,
pertaining to the submission of
nonclinical and preclinical data,
including a pediatric clinical
development plan, have been approved
under OMB control number 0910–0014;
the collections of information in 21 CFR
part 58 pertaining to good laboratory
practice for nonclinical laboratory
studies have been approved under OMB
control number 0910–0119; and the
collections of information in FDA’s
guidance for industry on ‘‘Expedited
Programs for Serious Conditions—Drugs
and Biologics’’ has been approved under
OMB control number 0910–0765.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.regulations.gov, https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, or https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances.
Dated: May 6, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–09964 Filed 5–11–21; 8:45 am]
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 12 abbreviated
new drug applications (ANDAs) from
multiple applicants. The applicants
notified the Agency in writing that the
drug products were no longer marketed
and requested that the approval of the
applications be withdrawn.
SUMMARY:
Approval is withdrawn as of
June 11, 2021.
DATES:
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0390]
Lederle Laboratories et al.; Withdrawal
of Approval of 12 Abbreviated New
Drug Applications
AGENCY:
ACTION:
Food and Drug Administration,
HHS.
Application No.
Drug
Applicant
ANDA 060164 .............
Nystatin Ointment ................................................................
ANDA 060521 .............
ANDA 061034 .............
Humatin (paromomycin sulfate) Capsules, Equivalent to
(EQ) 250 milligrams (mg)/base.
Lincomycin Hydrochloride (HCl) ..........................................
Lederle Laboratories, Division of American Cyanamid Co.,
P.O. Box 8299, Pearl River, NY 10965.
King Pharmaceuticals, 501 5th St., Bristol, TN 37620.
ANDA 061652 .............
ANDA 061701 .............
Oxytetracycline ....................................................................
Tetracycline ..........................................................................
ANDA 062032 .............
ANDA 076490 .............
Erypar (erythromycin stearate) Tablets, EQ 250 mg/base
and EQ 500 mg/base.
Lithium Carbonate Extended-Release Tablets, 450 mg .....
ANDA
ANDA
ANDA
ANDA
.............
.............
.............
.............
Triamcinolone Acetonide Foam ...........................................
Chlorpromazine HCl Tablets, 10 mg ...................................
Butalbital; Aspirin; Phenacetin; Caffeine, Tablets ...............
Ranitidine HCl Syrup, EQ 15 mg base/milliliters .................
ANDA 206736 .............
Rifampin for Injection, 600 mg/vial ......................................
083001
084803
087635
090102
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of June 11, 2021.
Approval of each entire application is
withdrawn, including any strengths and
dosage forms inadvertently missing
VerDate Sep<11>2014
17:58 May 11, 2021
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The Upjohn Co. (formerly Pharmacia and Upjohn Co.),
7000 Portage Rd., Kalamazoo, MI 49001.
Parke Davis, 201 Tabor Rd., Morris Plains, NJ 07950.
Wyeth Pharmaceuticals, 1211 Sherwood Ave., Richmond,
VA 23220.
Parke Davis.
Hikma Pharmaceuticals USA Inc., 1809 Wilson Rd., Columbus, OH 43228.
Lederle Laboratories.
Do.
Do.
Torrent Pharma Inc., 150 Allen Rd., Suite 102, Basking
Ridge, NJ 07920.
Watson Pharmaceuticals, Inc. (an indirect, wholly owned
subsidiary of Teva Pharmaceuticals USA, Inc.), 400
Interpace Pkwy., Building A, Parsippany, NJ 07054.
from the table. Introduction or delivery
for introduction into interstate
commerce of products without
approved new drug applications
violates section 301(a) and (d) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331(a) and (d)). Drug
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products that are listed in the table that
are in inventory on June 11, 2021 may
continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
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]]>Agencies
[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26056-26058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09964]
-----------------------------------------------------------------------
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 Pharmaceuticals; International Council for Harmonisation;
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 final guidance for industry entitled ``S11
Nonclinical Safety Testing in Support of Development of Pediatric
Pharmaceuticals.'' The guidance was prepared under the auspices of the
International Council for Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH), formerly the
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use. The guidance recommends
international standards for the nonclinical safety studies recommended
to support the development of pediatric medicines. 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 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 3R (replace/reduce/refine) principles. Tissue
engineered products, gene and cellular therapies, and vaccines are
excluded from the scope of this guidance. The guidance replaces the
draft guidance issued on February 1, 2019.
DATES: The announcement of the guidance is published in the Federal
Register on May 12, 2021.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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 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 between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
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
[[Page 26057]]
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.govinfo.gov/content/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, 240-402-7500.
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. 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 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, Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002, 301-796-5259,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``S11 Nonclinical Safety Testing in Support of Development of
Pediatric Pharmaceuticals.'' The guidance was prepared under the
auspices of ICH. ICH has the mission of achieving greater regulatory
harmonization worldwide to ensure that safe, effective, high-quality
medicines are developed, registered, and maintained in the most
resource-efficient manner. By harmonizing the regulatory requirements
in regions around the world, ICH guidelines have substantially reduced
duplicative clinical studies, prevented unnecessary animal studies,
standardized the reporting of important safety information,
standardized marketing application submissions, and made many other
improvements in the quality of global drug development and
manufacturing and the products available to patients.
The six Founding Members of the ICH are FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. Additionally, the
Membership of ICH has expanded to include other regulatory authorities
and industry associations from around the world (refer to https://www.ich.org/).
ICH works by involving technical experts from both regulators and
industry parties in detailed technical harmonization work and the
application of a science-based approach to harmonization through a
consensus-driven process that results in the development of ICH
guidelines. The regulators around the world are committed to
consistently adopting these consensus-based guidelines, realizing the
benefits for patients and for industry.
As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited. In the Federal Register of February 1, 2019 (84 FR 1161),
FDA published a notice announcing the availability of a draft guidance
entitled ``S11 Nonclinical Safety Testing in Support of Development of
Pediatric Medicines.'' The notice gave interested persons an
opportunity to submit comments by April 2, 2019. After consideration of
the comments received and revisions to the guideline, a final draft of
the guideline was submitted to the ICH Assembly and endorsed by the
regulatory agencies in April 2020.
This guidance finalizes the draft guidance issued on February 1,
2019. The 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 guidance also provides
appropriate study designs. The 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 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 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 3R (replace/reduce/refine) principles.
The draft guidance was revised based on comments received. The
revisions include refinement of the weight of evidence approach and in
descriptions of the core and additional endpoints that can be
incorporated into juvenile animal studies. The final guidance also
includes a new section on data interpretation. The appendices on age-
dependent development of organ systems by species and preweaning litter
allocation in the rodent were also updated. Additionally, the title of
the guidance was updated from ``Nonclinical Safety Testing in Support
of Development of Pediatric Medicines'' to ``Nonclinical Safety Testing
in Support of Development of Pediatric Pharmaceuticals.''
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This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``S11 Nonclinical Safety Testing in Support
of Development of Pediatric 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.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312, pertaining to the submission of
nonclinical and preclinical data, including a pediatric clinical
development plan, have been approved under OMB control number 0910-
0014; the collections of information in 21 CFR part 58 pertaining to
good laboratory practice for nonclinical laboratory studies have been
approved under OMB control number 0910-0119; and the collections of
information in FDA's guidance for industry on ``Expedited Programs for
Serious Conditions--Drugs and Biologics'' has been approved under OMB
control number 0910-0765.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.
Dated: May 6, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-09964 Filed 5-11-21; 8:45 am]
BILLING CODE 4164-01-P
