[Federal Register Volume 87, Number 173 (Thursday, September 8, 2022)]
[Notices]
[Pages 55010-55011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Studies of Drugs, Including Biological Products; Draft Guidance for 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the availability of a revised draft guidance for industry entitled 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draft guidance of the same name. This draft guidance, once finalized, 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addition, this draft guidance, once finalized, will assist 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DATES: Submit either electronic or written comments on the draft 
guidance by December 7, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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-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 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.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.
    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, [email protected].

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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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