Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Notices 105617 

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. 

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 

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-2022- 

P-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/2023- 

07/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/2023- 

05/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-pep24-02- 

013.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 

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-pep23-02-01- 

002.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 

AGENCY: Indian Health Service, HHS. 

ACTION: Notice and request for 

comments; request for extension of 

approval. 

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– 


khammond on DSK9W7S144PROD with NOTICES
105618 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. 

SUPPLEMENTARY INFORMATION: This 

previously approved 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 2- 

year 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. 

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 2998.5 


khammond on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Notices 105619 

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] 

BILLING CODE 4165–16–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Closed Meeting 

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, 

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) 

Dated: December 20, 2024. 

Bruce A. George, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–30957 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 

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 

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 


khammond on DSK9W7S144PROD with NOTICES