[Federal Register Volume 88, Number 96 (Thursday, May 18, 2023)]
[Notices]
[Pages 31766-31767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10611]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2005-D-0460]
Pediatric Drug Development Under the Pediatric Research Equity
Act and the Best Pharmaceuticals for Children Act: Scientific
Considerations; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Pediatric Drug
Development Under the Pediatric Research Equity Act and the Best
Pharmaceuticals for Children Act: Scientific Considerations.'' This
draft guidance addresses selected clinical, scientific, and ethical
issues involved in developing drugs, including biological products, for
pediatric use when such drug products are subject to the Pediatric
Research Equity Act (PREA) and/or the Best Pharmaceuticals for Children
Act (BPCA). This draft guidance is intended to assist industry in
obtaining the data and information necessary to support the approval of
drug products in pediatric populations. This draft guidance does not
address the clinical development of drug products that are not subject
to either PREA or the BPCA.
DATES: Submit either electronic or written comments on the draft
guidance by July 17, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-2005-D-0460 for ``Pediatric Drug Development Under the Pediatric
Research Equity Act and the Best Pharmaceuticals for Children Act:
Scientific Considerations.'' 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 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 the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Bldg., 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
[[Page 31767]]
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Rosemary Addy, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6430, Silver Spring, MD 20993-0002, 301-
796-2200, [email protected]; or Diane Maloney, 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.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Pediatric Drug Development Under the Pediatric Research
Equity Act and the Best Pharmaceuticals for Children Act: Scientific
Considerations.'' This draft guidance addresses selected clinical,
scientific, and ethical issues involved in developing drugs for
pediatric use when such drugs are subject to PREA and/or the BPCA. This
draft guidance, along with the draft guidance entitled ``Pediatric Drug
Development: Regulatory Considerations--Complying With the Pediatric
Research Equity Act and Qualifying for Pediatric Exclusivity Under the
Best Pharmaceuticals for Children Act,'' revises and replaces the draft
guidance entitled ``How to Comply with the Pediatric Research Equity
Act.'' \1\ This draft guidance also addresses certain additional topics
that FDA has not previously addressed in guidance.
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\1\ This draft guidance also addresses certain topics previously
addressed in the guidance for industry entitled ``Qualifying for
Pediatric Exclusivity Under Section 505A of the Federal Food, Drug,
and Cosmetic Act.'' That guidance was withdrawn August 7, 2013 (78
FR 48175).
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The purpose of this draft guidance is to assist industry in
obtaining the data and information needed to support approval of drug
products in pediatric populations. Specifically, this draft guidance
describes considerations regarding data in pediatric patients with
particular discussion regarding formulation development, nonclinical
information, clinical pharmacology, and safety information.
Additionally, the draft guidance discusses pediatric extrapolation,
timing of pediatric studies, and drug development for the neonatal
population. This draft guidance does not address the clinical
development of drugs that are not subject to either PREA or the BPCA.
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 ``Pediatric
Drug Development Under the Pediatric Research Equity Act and the Best
Pharmaceuticals for Children Act: Scientific Considerations.'' 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. The 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 parts 50 and 56 for protection of human
subjects and institutional review boards, have been approved under OMB
control number 0910-0130. The collections of information in 21 CFR 210
and 211 for current good manufacturing practice have been approved
under OMB control number 0910-0139. The collections of information in
21 CFR part 312 for investigational new drug applications and 21 CFR
part 314 for new drug applications and abbreviated new drug
applications have been approved under OMB control numbers 0910-0014 and
0910-0001, respectively. The collections of information in 21 CFR parts
601 and 610 for biologics license applications have been approved under
OMB control number 0910-0338. The collections of information in 42
U.S.C. 262(k) and 21 U.S.C. 379g for biosimilar applications have been
approved under OMB control number 0910-0718. The collections of
information in 21 CFR 201.56 and 201.57 regarding labeling requirements
for prescription drugs have been approved under OMB control number
0910-0572. The collections of information in 21 CFR part 201, subpart C
regarding over-the-counter products have been approved under OMB
control number 0910-0340. The collections of information in 21 CFR part
316 regarding orphan drug product development are approved under OMB
control number 0910-0167.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: May 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10611 Filed 5-17-23; 8:45 am]
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