Notice2022-19410
General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products; Draft Guidance for Industry; Availability
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Published
September 8, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products," replacing the December 2014 draft guidance of the same name. This draft guidance, once finalized, will assist sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and supplements to such applications, who are planning to conduct clinical studies in pediatric populations. In addition, this draft guidance, once finalized, will assist investigators in the design and planning of, and Institutional Review Boards in the assessment of, clinical studies in pediatric populations.
Full Text
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<title>Federal Register, Volume 87 Issue 173 (Thursday, September 8, 2022)</title>
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[Federal Register Volume 87, Number 173 (Thursday, September 8, 2022)]
[Notices]
[Pages 55010-55011]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-19410]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-1275]
General Clinical Pharmacology Considerations for Pediatric
Studies of Drugs, Including Biological Products; Draft Guidance for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 or Agency) is announcing
the availability of a revised draft guidance for industry entitled
``General Clinical Pharmacology Considerations for Pediatric Studies of
Drugs, Including Biological Products,'' replacing the December 2014
draft guidance of the same name. This draft guidance, once finalized,
will assist sponsors of investigational new drug applications (INDs)
and applicants of new drug applications (NDAs), biologics license
applications (BLAs), and supplements to such applications, who are
planning to conduct clinical studies in pediatric populations. In
addition, this draft guidance, once finalized, will assist
investigators in the design and planning of, and Institutional Review
Boards in the assessment of, clinical studies in pediatric populations.
DATES: Submit either electronic or written comments on the draft
guidance by December 7, 2022 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2013-D-1275 for ``General Clinical Pharmacology Considerations for
Pediatric Studies of Drugs and Biological Products.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 the draft 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. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Elimika Pfuma Fletcher, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2162,
[[Page 55011]]
Silver Spring, MD 20993, 301-796-3473, <a href="/cdn-cgi/l/email-protection#4e0b22272327252f6008222b3a2d262b3c0e282a2f6026263d60292138"><span class="__cf_email__" data-cfemail="37725b5e5a5e5c5619715b5243545f524577515356195f5f4419505841">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft guidance for
industry entitled ``General Clinical Pharmacology Considerations for
Pediatric Studies of Drugs, Including Biological Products.''
Effectiveness, safety, or dose-finding studies in pediatric patients
involve gathering clinical pharmacology information, such as
information regarding a product's pharmacokinetics and
pharmacodynamics, to inform dose selection and individualization. This
draft guidance addresses general clinical pharmacology considerations
for conducting studies so that the dosing and safety information for
drugs and biological products in pediatric populations can be
sufficiently characterized, leading to well-designed trials to evaluate
effectiveness.
In general, this draft guidance focuses on the clinical
pharmacology information (e.g., exposure-response, pharmacokinetics,
and pharmacodynamics) that supports findings of effectiveness and
safety and helps identify appropriate doses in pediatric populations.
This draft guidance also describes how quantitative approaches (i.e.,
pharmacometrics) can use disease and exposure-response knowledge from
relevant prior clinical studies to help design and evaluate future
pediatric studies.
This draft guidance revises the draft guidance, ``General Clinical
Pharmacology Considerations for Pediatric Studies of Drugs and
Biological Products,'' issued on December 9, 2014 (79 FR 73079). This
draft guidance provides clarification on clinical pharmacology studies
in pediatric patients from the 2014 draft guidance in response to
public comments.
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 ``General
Clinical Pharmacology Considerations for Pediatric Studies of Drugs and
Biological Products.'' 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
This draft guidance refers to previously approved FDA collections
of information. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of
information for the submission of new drug applications in 21 CFR part
314 have been approved under OMB control number 0910-0001. The
collections of information for the submission of biologics license
applications in 21 CFR part 601 have been approved under OMB control
number 0910-0338. The collections of information for the submission of
investigational new drug applications in 21 CFR part 312 have been
approved under OMB control number 0910-0014. The collections of
information for the protection of human subjects and institutional
review boards in parts 21 CFR parts 50 and 56 have been approved under
OMB control number 0910-0130. The collections of information for the
submission of prescription drug product labeling in 21 CFR 201.56 and
201.57 have been approved under OMB control number 0910-0572. The
collections of information in 21 CFR 312.47 and 312.82 for requesting
meetings with FDA about drug development programs have been approved
under OMB control number 0910-0429.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm">https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: September 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19410 Filed 9-7-22; 8:45 am]
BILLING CODE 4164-01-P
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