Notice2022-20720
Ethical Considerations for Clinical Investigations of Medical Products Involving Children; Draft Guidance for Industry, Sponsors, and Institutional Review Boards; Availability
Primary source
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Published
September 26, 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, sponsors, and institutional review boards (IRBs) entitled "Ethical Considerations for Clinical Investigations of Medical Products Involving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 This draft guidance describes FDA's current thinking regarding ethical considerations for clinical investigations of drugs, biological products, and medical devices (collectively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 The draft guidance is intended to assist industry, sponsors, and IRBs when considering the enrollment of children in clinical investigations of medical products.
Full Text
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<title>Federal Register, Volume 87 Issue 185 (Monday, September 26, 2022)</title>
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[Federal Register Volume 87, Number 185 (Monday, September 26, 2022)]
[Notices]
[Pages 58357-58359]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Products Involving Children; Draft Guidance for Industry, Sponsors, and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the availability of a draft guidance for industry, sponsors, and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This draft guidance describes FDA's current thinking regarding ethical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 The draft guidance is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:
<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-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 <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, 240-402-7500.
<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, 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 <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</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 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
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