[Federal Register Volume 87, Number 185 (Monday, September 26, 2022)]
[Notices]
[Pages 58357-58359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20720]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0738]


Ethical Considerations for Clinical Investigations of Medical 
Products Involving Children; Draft Guidance for Industry, Sponsors, and 
Institutional Review Boards; 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the availability of a draft guidance for industry, sponsors, and 
institutional review boards (IRBs) entitled ``Ethical Considerations 
for Clinical Investigations of Medical Products Involving Children.'' 
This draft guidance describes FDA's current thinking regarding ethical 
considerations for clinical investigations of drugs, biological 
products, and medical devices (collectively referred to as ``medical 
products'' in this notice) involving children. The draft guidance is 
intended to assist industry, sponsors,

[[Page 58358]]

and IRBs when considering the enrollment of children in clinical 
investigations of medical products.

DATES: Submit either electronic or written comments on the draft 
guidance by December 27, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2022-D-0738 for ``Ethical Considerations for Clinical 
Investigations of Medical Products Involving Children.'' 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 Office of Pediatric Therapeutics, Office of the Commissioner, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5126, 
Silver Spring, MD 20993-0002; 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; 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; or to the Office of Policy, Guidance and Policy 
Development, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, 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 the Center for Biologics Evaluation and 
Research 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: Donna Snyder, Office of Pediatric 
Therapeutics, Office of the Commissioner, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 32, Rm. 5121, Silver Spring, MD 20993-
0002, 301-796-1397; or John J. Alexander, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 5490, Silver Spring, MD 20993-0002, 301-796-0665; 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; or Ouided Rouabhi, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, Rm. G221, Silver Spring, MD 20993-
0002, 240-402-2672.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for 
industry, sponsors, and IRBs entitled ``Ethical Considerations for 
Clinical Investigations of Medical Products Involving Children.'' This 
draft guidance describes FDA's current thinking regarding ethical 
considerations for clinical investigations of drugs, biological 
products, and medical devices (collectively referred to as ``medical 
products'' herein) involving children.
    Clinical investigations involving children are essential for 
obtaining data on the safety and effectiveness of medical products in 
children and to protect children from the risks associated with 
exposure to medical products that may be unsafe or ineffective. 
Children are a vulnerable population who cannot consent for themselves 
and who therefore are afforded additional safeguards when

[[Page 58359]]

participating in a clinical investigation. Such safeguards are an 
essential requirement for the initiation and conduct of pediatric 
investigations as part of a medical product development program.
    This draft guidance describes the ethical framework in FDA's 
regulations, including the principle of scientific necessity, the risk 
categories for interventions or procedures without the prospect of 
direct benefit, considerations regarding the prospect of direct 
benefit, the assessment of risk for interventions or procedures with a 
prospect of direct benefit, evaluations for the different components of 
a clinical investigation using component analysis of risk, the 
potential for review of a protocol under 21 CFR 50.54, and the 
necessity of obtaining parental/guardian permission and child assent. 
The draft guidance also describes the application of 21 CFR part 50, 
subpart D to pediatric clinical investigations, including the data to 
support conducting pediatric clinical investigations, design 
considerations for clinical investigations, and study procedures in 
pediatric clinical investigations.
    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 ``Ethical 
Considerations for Clinical Investigations of Medical Products 
Involving Children.'' 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 parts 50 and 56 have been approved under OMB 
control number 0910-0130, the collections of information in 21 CFR part 
312 have been approved under OMB control number 0910-0014, and the 
collections of information in 21 CFR part 812 have been approved under 
OMB control number 0910-0078.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either 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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: September 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20720 Filed 9-23-22; 8:45 am]
BILLING CODE 4164-01-P