Lrp 60 Frn 2024

Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Notices
the relevant sections of the labeling
identified in this notice, which include
the ‘‘Dosage and Administration’’ and
‘‘Use in Specific Populations’’ sections
of BTOD labeling.
III. Electronic Submissions
Submit any draft labeling as a prior
approval supplement to your NDA. Any
labeling supplement must be submitted
in the electronic common technical
document (eCTD) standard format. The
eCTD is the standard format for
electronic regulatory submissions to
FDA’s Center for Drug Evaluation and
Research. The FDA Electronic
Submissions Gateway (available at:
https://www.fda.gov/industry/
electronic-submissions-gateway) is the
central transmission point for sending
information electronically to FDA and
enables the secure submission of
regulatory information for review.

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IV. References
The following references marked with
an asterisk (*) are on display at the
Dockets Management Staff (see
ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they also are available
electronically at https://
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff.
Although FDA verified the website
addresses in this document, please note
that websites are subject to change over
time.
1. * Labeling for SUBUTEX (buprenorphine
HCl) (NDA 020732) and SUBOXONE
(buprenorphine HCl and naloxone HCl)
(NDA 020733) sublingual tablets, Oct. 8,
2002, available at: https://
www.accessdata.fda.gov/drugsatfda_
docs/label/2002/20732,20733lbl.pdf.
2. * Supplement Approval for SUBUTEX
(buprenorphine HCl) sublingual tablets
(NDA 020732), Dec. 22, 2011, available
at: https://www.accessdata.fda.gov/
drugsatfda_docs/appletter/2011/
020732s006,s007ltr.pdf.
3. * Labeling for SUBUTEX (buprenorphine
HCl) sublingual tablets (NDA 020732),
Dec. 22, 2011, available at: https://
www.accessdata.fda.gov/drugsatfda_
docs/label/2011/020732s006s007lbl.pdf.
4. * Supplement Approval for SUBOXONE
(buprenorphine HCl and naloxone HCl)
sublingual tablets (NDA 020733), Dec.
22, 2011, available at: https://
www.accessdata.fda.gov/drugsatfda_
docs/appletter/2011/
020733s007,s008ltr.pdf.
* 5. Labeling for SUBOXONE (buprenorphine

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HCl and naloxone HCl) sublingual
tablets (NDA 020733), Dec. 22, 2011,
available at: https://
www.accessdata.fda.gov/drugsatfda_
docs/label/2011/020733s007s008lbl.pdf.
* 6. Labeling for SUBUTEX (buprenorphine
HCl) sublingual tablets (NDA 020732),
June 17, 2022, available at: https://
www.accessdata.fda.gov/drugsatfda_
docs/label/2022/020732s027s028lbl.pdf.
* 7. Labeling for SUBOXONE (buprenorphine
HCl and naloxone HCl) sublingual
tablets (NDA 020733), June 17, 2022,
available at: https://
www.accessdata.fda.gov/drugsatfda_
docs/label/2022/020733s031s032lbl.pdf.
* 8. ZUBSOLV (buprenorphine HCl and
naloxone HCl) sublingual tablets (NDA
204242), Dec. 15, 2023, available at:
https://www.accessdata.fda.gov/
drugsatfda_docs/label/2023/
204242s027lbl.pdf.
* 9. BUNAVAIL (buprenorphine HCl and
naloxone HCl) buccal film (NDA
205637), June 17, 2022, available at:
https://www.accessdata.fda.gov/
drugsatfda_docs/label/2022/
205637s023s024lbl.pdf.
* 10. Citizen petition submitted by the
Colorado Society of Addiction Medicine
(FDA–2022–P–1863), posted Aug. 10,
2022, available at: https://
www.regulations.gov/docket/FDA-2022P-1863.
11. Reagan-Udall Foundation, virtual public
meeting entitled ‘‘Considerations for
Buprenorphine Initiation and
Maintenance Care,’’ May 10–11, 2023,
meeting materials and transcripts
available at: https://reaganudall.org/
news-and-events/events/considerationsbuprenorphine-initiation-andmaintenance-care.
12. Reagan-Udall Foundation, Meeting
Transcript, ‘‘Considerations for
Buprenorphine Initiation and
Maintenance Care—Day One,’’ May 10,
2023, available at: https://
reaganudall.org/sites/default/files/202307/Transcript%20-%20Bupre
norphine%20Initiation%20%20Day%201%20%20REVISED%20FINAL.pdf.
13. Reagan-Udall Foundation, Meeting
Transcript, ‘‘Considerations for
Buprenorphine Initiation and
Maintenance Care—Day Two,’’ May 11,
2023, available at: https://
reaganudall.org/sites/default/files/202305/Transcript%20-%20Buprenorphine
%20Initiation%20-%20Day%202%20%20final.pdf.
* 14. SAMHSA, Meeting Summary,
‘‘Listening Session: Use of High Dose
Buprenorphine for the Treatment of
Opioid Use Disorder,’’ December 11,
2023, available at: https://
store.samhsa.gov/sites/default/files/highdose-buprenorphine-report-pep24-02013.pdf.
15. Grande, LA, D Cundiff, MK Greenwald,
et al., 2023, ‘‘Evidence on
Buprenorphine Dose Limits: A Review,’’
J Addict Med, 17(5): 509–516.
16. Tiako, MJN, A Dolan, M Abrams, et al.,
2023, ‘‘Thematic Analysis of State

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Medicaid Buprenorphine Prior
Authorization Requirements,’’ JAMA
Netw Open, 6(6):e2318487.
17. Bakaysa, S, S Heil, and M Meyer, 2009,
‘‘833: Buprenorphine Dose Changes
During Gestation,’’ Am J Obstet Gynecol,
201(6):S297–S298.
18. Martin, CE, C Shadowen, B Thakkar, et
al., 2020, ‘‘Buprenorphine Dosing for the
Treatment of Opioid Use Disorder
Through Pregnancy and Postpartum,’’
Curr Treat Options Psychiatry, 7(3): 375–
399.
19. The American College of Obstetricians
and Gynecologists, ‘‘Opioid Use and
Opioid Use Disorder in Pregnancy,’’
Committee Opinion Number 711, August
2017, available at: https://www.acog.org/
clinical/clinical-guidance/committeeopinion/articles/2017/08/opioid-useand-opioid-use-disorder-in-pregnancy.
* 20. Substance Abuse and Mental Health
Services Administration (SAMHSA)
Advisory, ‘‘Evidence-Based, WholePerson Care for Pregnant People Who
Have Opioid Use Disorder,’’ March 2024,
available at: https://store.samhsa.gov/
sites/default/files/whole-person-carepregnant-people-oud-pep23-02-01002.pdf.
* 21. Supplement Approval for SUBOXONE
(buprenorphine HCl and naloxone HCl)
sublingual film (NDA 022410), Feb. 13,
2017, available at: https://
www.accessdata.fda.gov/drugsatfda_
docs/appletter/2017/
022410Orig1s023ltr.pdf.
22. Concheiro, M, HE Jones, RE Johnson, et
al., 2011, ‘‘Preliminary Buprenorphine
Sublingual Tablet Pharmacokinetic Data
in Plasma, Oral Fluid and Sweat During
Treatment of Opioid-Dependent
Pregnant Women,’’ The Drug Monit,
33(5):619–626.
Dated: December 18, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–30776 Filed 12–26–24; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Request for Public Comment: 60-Day
Notice for Extension of the Indian
Health Service Loan Repayment
Program
Indian Health Service, HHS.
Notice and request for
comments; request for extension of
approval.

AGENCY:
ACTION:

SUMMARY: In compliance with the
Paperwork Reduction Act of 1995, the
Indian Health Service (IHS) invites the
general public to take this opportunity
to comment on the information
collection Office of Management and
Budget (OMB) Control Number 0917–

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Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Notices

0014, titled, ‘‘IHS Loan Repayment
Program (LRP).’’ This notice announces
our intent to submit this collection,
which expires February 28, 2025, to the
OMB for approval of an extension and
solicit comments on specific aspects for
the proposed information collection.
DATES: Consideration will be given to all
comments received by February 25,
2025.
ADDRESSES:

For Comments: Submit comments to
Correy Ahhaitty by one of the following
methods:
• Email: Correy.Ahhaitty@ihs.gov.
• Phone: (301) 443–2544.
Comments submitted in response to
this notice will be made available to the
public by publishing them in the 30-day
Federal Register Notice for this
information collection. For this reason,
please do not include information of a
confidential nature, such as sensitive
personal information or proprietary
information. If comments are submitted
via email, the email address will be
automatically captured and included as
part of the comment that is placed in the
public docket and made available on the
internet. Please note that responses to
this public comment request containing
any routine notice about the
confidentiality of the communication
will be treated as public comments that
may be made available to the public
notwithstanding the inclusion of the
routine notice.
A copy of the draft supporting
statement is available at
www.regulations.gov (see Docket ID
(IHS_FRDOC_0001)).
FOR FURTHER INFORMATION CONTACT: To
request additional information, please
contact Patricia Lawton, Information
Collection Clearance Officer at:
Patricia.Lawton@ihs.gov or 240–381–
9031.
This
previously approved information

SUPPLEMENTARY INFORMATION:

collection project was last published in
the Federal Register (86 FR 60055) on
October 29, 2021, and allowed 30 days
for public comment. No public
comment was received in response to
the notice.
The IHS is submitting the proposed
information collection to the OMB for
review, as required by the Paperwork
Reduction Act of 1995, as amended, and
its implementing regulations. This
notice is soliciting comments from
members of the public and affected
agencies as required by 44 U.S.C.
3506(c)(2)(A) and 5 CFR 1320.8(d)
concerning the proposed collection of
information to: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the Agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the Agency’s estimate of the
burden of the proposed collection of
information; (3) Enhance the quality,
utility, and clarity of the information to
be collected; and (4) Minimize the
burden of the collection of information
on those who are to respond; including
through the use of appropriate
automated collection techniques of
other forms of information technology,
e.g., permitting electronic submission of
responses.
Title: 0917–0014, ‘‘Indian Health
Service Loan Repayment Program.’’
Type of Information Collection
Request: 3-year extension approval of
this information collection.
OMB Control Number: 0917–0014.
Forms: Educational and Professional
Background, Financial Information, and
General Applicant Information (i.e., all
forms are part of the LRP application).
The LRP application is available in an
electronically fillable and fileable
format.
Need and Use of Information
Collection: The IHS LRP identifies
health professionals with pre-existing

financial obligations for education
expenses that meet program criteria and
who are qualified and willing to serve
at, often remote, IHS health care
facilities. Under the program, eligible
health professionals sign a contract
through which the IHS agrees to repay
part or all of their indebtedness in
exchange for an initial 2-year service
commitment to practice full-time at an
eligible Indian health program. This
program is necessary to augment the
critically low health professional staff at
IHS health care facilities.
Eligible health professionals wishing
to have their health education loans
repaid may apply to the IHS LRP. A 2year contract obligation is signed by
both parties, and the individual agrees
to work at an eligible Indian health
program location and provide health
services to American Indian and Alaska
Native individuals.
The information collected via the
online application from individuals is
analyzed and a score is given to each
applicant. This score will determine
which applicants will be awarded each
fiscal year (FY). The administrative
scoring system assigns a score to the
geographic location according to
vacancy rates for that FY and also
considers whether the location is in an
isolated area. When an applicant
accepts employment at a location, the
applicant in turn ‘‘picks-up’’ the score
of that location.
Status of the Proposed Information
Collection: Renewal of a current
collection.
Affected Public: Individuals and
households.
Type of Respondents: Individuals.
The table below provides: Types of
data collection instruments, estimated
number of respondents, number of
responses per respondent, average
burden hour per response, and total
annual burden hours.

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ESTIMATED BURDEN HOURS

Data collection instrument(s)

Number of
respondents

Number of
responses
per respondent

Average
burden
per response
(in hours)

Total
annual
burden
responses
(in hours)

LRP Application (3 forms in total) ....................................................................

1999

1

1.5

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Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Notices
There are no Capital Costs, Operating
Costs, and/or Maintenance Costs to
report.
Roselyn Tso,
Director, Indian Health Service.
[FR Doc. 2024–31030 Filed 12–26–24; 8:45 am]

Dated: December 20, 2024.
Bruce A. George,
Program Analyst, Office of Federal Advisory
Committee Policy.

BILLING CODE 4165–16–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[FR Doc. 2024–30957 Filed 12–26–24; 8:45 am]
BILLING CODE 4140–01–P

National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meeting

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Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Board of Scientific
Counselors, National Institute of Mental
Health.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), title 5 U.S.C., as amended for
the review, discussion, and evaluation
of individual intramural programs and
projects conducted by the National
Institute of Mental Health, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, National Institute of Mental
Health.
Date: February 5–7, 2025.
Time: February 05, 2025, 9:30 a.m. to 6:15
p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Address: Porter Neuroscience Research
Center, Building 35A, 35 Convent Drive,
Bethesda, MD 20892 (In Person and Virtual
Meeting).
Time: February 06, 2025, 10:00 a.m. to 5:15
p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Address: Porter Neuroscience Research
Center, Building 35A, 35 Convent Drive,
Bethesda, MD 20892 (In Person and Virtual
Meeting).
Time: February 07, 2025, 10:00 a.m. to 3:15
p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Address: Porter Neuroscience Research
Center, Building 35A, 35 Convent Drive,
Bethesda, MD 20892 (In Person and Virtual
Meeting).
Contact Person: Jennifer E Mehren, Ph.D.,
Scientific Advisor, Division of Intramural
Research Programs, National Institute of
Mental Health, National Institutes of Health,

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35A Convent Drive, Bethesda, MD 20892–
3747, 301–496–3501, email: mehrenj@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)

Jkt 265001

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Aging and
Spinal Cord Injury.
Date: February 12, 2025.
Time: 1:30 p.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Address: National Institute on Aging, 5601
Fishers Lane, Suite 8B, Rockville, MD 20892.
Meeting Format: Virtual Meeting.Contact
Person: Michael James Butler, Ph.D.,
Scientific Review Officer National Institute
on Aging, National Institutes of Health, 5601
Fishers Lane, Suite 8B, Rockville, MD 20852,
(301) 496–9666, michael.butler@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: December 19, 2024
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–30879 Filed 12–26–24; 8:45 am]
BILLING CODE 4140–01–P

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Maternal
Nutrition and Aging.
Date: February 4, 2025.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Address: National Institute on Aging, 5601
Fishers Lane, Suite 8B, Rockville, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Kaitlyn Noel Lewis
Hardell, Ph.D., MPH, Scientific Review
Officer, National Institute on Aging, National
Institutes of Health, 5601 Fishers Lane, Suite
8B, Rockville, MD 20892, (301) 594–7945,
kaitlyn.hardell@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: December 19, 2024.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–30881 Filed 12–26–24; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial

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