Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies; Guidance for Industry; Availability
| Published date | 18 July 2024 |
| Record Number | 2024-15812 |
| Citation | 89 FR 58383 |
| Court | Food And Drug Administration |
| Section | Notices |
Federal Register, Volume 89 Issue 138 (Thursday, July 18, 2024)
[Federal Register Volume 89, Number 138 (Thursday, July 18, 2024)]
[Notices]
[Pages 58383-58384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15812]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-0113]
Clinical Pharmacology Considerations for Human Radiolabeled Mass
Balance Studies; 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 final guidance for industry entitled ``Clinical
Pharmacology Considerations for Human Radiolabeled Mass Balance
Studies.'' This guidance describes FDA's recommendations regarding
clinical pharmacology considerations for conducting human radiolabeled
mass balance studies, including deciding whether and when to conduct
the study, designing the study, and reporting results.
DATES: The announcement of the guidance is published in the Federal
Register on July 18, 2024.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-0113 for ``Clinical Pharmacology Considerations for Human
Radiolabeled Mass Balance Studies.'' 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
[[Page 58384]]
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 this 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Anuradha Ramamoorthy, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20903,
[email protected], 240-402-6426.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Clinical Pharmacology Considerations for Human Radiolabeled
Mass Balance Studies.'' A human radiolabeled mass balance study is the
single most direct study to obtain quantitative and comprehensive
information on the absorption, distribution, metabolism, and excretion
of an investigational drug in the human body. The mass balance study
can provide information to determine the overall pathways of metabolism
and excretion of an investigational drug, identify circulating
metabolites, and determine the abundance of metabolites relative to the
parent or total drug-related exposure. This guidance provides FDA's
recommendations for clinical pharmacology considerations in conducting
human radiolabeled mass balance studies during drug development,
including: (1) deciding whether and when to conduct the study, (2)
designing the study, and (3) reporting the study results.
This guidance finalizes the draft guidance of the same name issued
on May 5, 2022 (87 FR 26763). FDA considered comments received on the
draft guidance as the guidance was finalized. Changes from the draft to
the final guidance include: (1) updates to terms used in the guidance
to provide clarity, (2) additional references that have been published
since the draft guidance was issued, and (3) editorial changes to
improve clarity.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Clinical Pharmacology Considerations for
Human Radiolabeled Mass Balance Studies.'' 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. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR 201.57 relating to prescription product labeling requirements
have been approved under OMB control number 0910-0572. The collections
of information for 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 submission of new drug
applications in 21 CFR part 314 have been approved under OMB control
number 0910-0001.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: July 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15812 Filed 7-17-24; 8:45 am]
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