Notice2022-23730
Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials; Draft Guidance for Industry; Availability
Primary source
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Published
November 1, 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials." The purpose of this draft guidance is to outline the most appropriate methods for measuring and recording growth and evaluating pubertal development for drugs or biological products in development for pediatric use when such an assessment is necessary to support safety. This draft guidance is intended to encourage a consistent approach to collecting interpretable and accurate growth and pubertal development data. This draft guidance does not address use of growth or pubertal development data to support primary evidence of efficacy in growth disorders and does not address evaluation of nutritional status.
Full Text
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<title>Federal Register, Volume 87 Issue 210 (Tuesday, November 1, 2022)</title>
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[Federal Register Volume 87, Number 210 (Tuesday, November 1, 2022)]
[Notices]
[Pages 65781-65782]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-23730]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-0760]
Measuring Growth and Evaluating Pubertal Development in Pediatric
Clinical Trials; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Measuring
Growth and Evaluating Pubertal Development in Pediatric Clinical
Trials.'' The purpose of this draft guidance is to outline the most
appropriate methods for measuring and recording growth and evaluating
pubertal development for drugs or biological products in development
for pediatric use when such an assessment is necessary to support
safety. This draft guidance is intended to encourage a consistent
approach to collecting interpretable and accurate growth and pubertal
development data. This draft guidance does not address use of growth or
pubertal development data to support primary evidence of efficacy in
growth disorders and does not address evaluation of nutritional status.
DATES: Submit either electronic or written comments on the draft
guidance by January 3, 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:
<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-0760 for ``Measuring Growth and Evaluating Pubertal
Development in Pediatric Clinical Trials.'' 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
[[Page 65782]]
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 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; 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 INFORMATION section for
electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: George Greeley, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6406, Silver Spring, MD 20993-002, 301-
796-4025; 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.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Measuring Growth and Evaluating Pubertal Development in
Pediatric Clinical Trials.'' The purpose of this draft guidance is to
assist sponsors in monitoring growth and pubertal development in
clinical trials that enroll pediatric patients with both rare and
common diseases. This draft guidance is focused on the most appropriate
methods for measuring and recording growth and evaluating pubertal
development for evaluation of safety.
If an investigational drug or biological product may affect growth
or pubertal development, then accurate, serial measurement and
recording of growth parameters are essential for data interpretation in
pediatric clinical trials. In general, growth is assessed using
measurements of weight, linear growth (length and height), and when
appropriate, head circumference. Additional measurements and
calculations may be needed in certain pediatric age groups and disease
populations. In general, pubertal development is assessed using
clinical phenotyping. Identifying the onset and progression of puberty
are essential for accurate interpretation of growth data.
This draft guidance addresses measurement of growth, evaluation of
pubertal development, and other measurements. The discussion of growth
measurements consists of general considerations to ensure accurate,
reproducible measurements followed by specific suggestions about how to
measure weight, linear growth (length and height), and head
circumference in the entire pediatric population starting at birth. The
recommendations for pubertal development focus on use of the sexual
maturity rating. The draft guidance also provides recommendations on
other measurements, specifically use of skeletal age and dual-energy X-
ray absorptiometry.
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 ``Measuring
Growth and Evaluating Pubertal Development in Pediatric Clinical
Trials.'' 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 new 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 part 312 have been approved under OMB control
number 0910-0014. The collection of information in 21 CFR part 314 has
been approved under OMB control number 0910-0001.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <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">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics</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: October 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23730 Filed 10-31-22; 8:45 am]
BILLING CODE 4164-01-P
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