Notice2022-09608
Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies; Draft Guidance for Industry; Availability
Primary source
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Published
May 5, 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies." This draft guidance describes the FDA's recommendations regarding clinical pharmacology considerations for conducting human radiolabeled mass balance studies, including deciding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.
Full Text
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<title>Federal Register, Volume 87 Issue 87 (Thursday, May 5, 2022)</title>
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[Federal Register Volume 87, Number 87 (Thursday, May 5, 2022)]
[Notices]
[Pages 26763-26764]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09608]
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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Balance Studies; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Clinical
Pharmacology Considerations for Human Radiolabeled Mass Balance
Studies.'' This draft guidance describes the FDA's recommendations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DATES: Submit either electronic or written comments on the draft
guidance by August 3, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the
[[Page 26764]]
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 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: Anuradha Ramamoorthy, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20903,
<a href="/cdn-cgi/l/email-protection#4e2f203b3c2f2a262f603c2f232f2321213c3a26370e282a2f6026263d60292138"><span class="__cf_email__" data-cfemail="ee8f809b9c8f8a868fc09c8f838f8381819c9a8697ae888a8fc086869dc0898198">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Clinical Pharmacology Considerations for Human Radiolabeled
Mass Balance Studies.'' A human radiolabeled mass balance study is the
single most direct method to obtain quantitative and comprehensive
information on the absorption, distribution, metabolism, and excretion
(ADME) 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, including: (1)
Deciding whether and when to conduct the study, (2) designing the
study, and (3) reporting results.
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 ``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. 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 for submission of investigational new drug applications
in 21 CFR part 312 have been approved under OMB control number 0910-
0014, and 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 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/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: April 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09608 Filed 5-4-22; 8:45 am]
BILLING CODE 4164-01-P
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