Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies; Guidance for Industry; Availability, 58383-58384 [2024-15812]
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Federal Register / Vol. 89, No. 138 / Thursday, July 18, 2024 / Notices
national minor and adult victims of
trafficking. If a requester encounters
issues submitting a request through
Shepherd, they may submit the RFA
form to OTIP as a password protected
PDF to childtrafficking@acf.hhs.gov.
Respondents: Representatives of
governmental entities, members of the
community, and nongovernmental
entities providing social, legal, or
protective services to foreign national
minors in the United States who may
have been subjected to severe forms of
trafficking in persons. Furthermore,
representatives within the community
with a concern that a foreign national
minor may have been subjected to
severe forms of trafficking in persons
may also use the RFA form.
Annual Burden Estimates
Increased awareness of reporting
requirements under the TVPA of 2000,
as amended among providers who serve
foreign national children and youth has
resulted in sustained, year-over-year
increases in the number of RFA forms
received by OTIP since fiscal year 2021.
While the number of RFA forms
received by OTIP each year largely
reflects OTIP’s efforts to engage case
managers, attorneys, law enforcement
officers, child welfare workers, and
other representatives who serve foreign
national children and youth, the
number of RFA forms received is also
impacted by a variety of social, political,
and environmental factors that impact
migration trends, including natural
Instrument
Total number
of
responses
per
respondent
Average
burden
hours
per
response
Total
burden
hours
Annual
burden
hours
10,500
1
1
10,500
3,500
The announcement of the
guidance is published in the Federal
Register on July 18, 2024.
DATES:
Mary C. Jones,
ACF/OPRE Certifying Officer.
BILLING CODE 4184–47–P
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Electronic Submissions
ADDRESSES:
[FR Doc. 2024–15789 Filed 7–17–24; 8:45 am]
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.
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.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:47 Jul 17, 2024
Jkt 262001
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
PO 00000
Frm 00057
disasters and other climate-mediated
events, that fluctuate each year. In fiscal
year 2021, a record number of unique
individuals (2,178) were referred to
OTIP through 2,650 total RFA forms. In
fiscal year 2022, 3,150 unique
individuals were referred to OTIP
through 3,709 total RFA forms. In fiscal
year 2023, 3,612 unique individuals
were referred to OTIP through 4,052
total RFA forms. There are no changes
proposed to the RFA form but based on
the increased need for traffickingspecific case management services
among foreign national children and
youth, as evidenced through sustained
increases in the volume of RFA forms
received by OTIP each year since fiscal
year 2021, burden estimates for this
collection have been revised.
Total number
of
respondents
Request for Assistance for Child Victims of Human Trafficking ...............................................................................
Authority: 22 U.S.C. 7105 (b)
58383
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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
E:\FR\FM\18JYN1.SGM
18JYN1
khammond on DSKJM1Z7X2PROD with NOTICES
58384
Federal Register / Vol. 89, No. 138 / Thursday, July 18, 2024 / Notices
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-201509-18/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, Anuradha.ramamoorthy@
fda.hhs.gov, 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
VerDate Sep<11>2014
16:47 Jul 17, 2024
Jkt 262001
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
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
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/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-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]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the Program), as required by
the Public Health Service (PHS) Act, as
amended. While the Secretary of HHS is
named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact Lisa L. Reyes, Clerk of
Court, United States Court of Federal
Claims, 717 Madison Place NW,
Washington, DC 20005, (202) 357–6400.
For information on HRSA’s role in the
Program, contact the Director, National
Vaccine Injury Compensation Program,
5600 Fishers Lane, Room 8W–25A,
Rockville, Maryland 20857; (301) 443–
6593, or visit our website at: https://
www.hrsa.gov/vaccinecompensation/
index.html.
SUPPLEMENTARY INFORMATION: The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
SUMMARY:
E:\FR\FM\18JYN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 4164-01-P
