Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices 63589 

unintended consequences might be 

unique to stakeholders like you? Why? 

6. FDA anticipates that each 

establishment would be provided with a 

detailed report following their QMM 

assessment. What would you want such 

a report to contain? 

7. With respect to the outcomes of a 

QMM assessment, what are your 

thoughts about making outcomes 

public? Would your thoughts be 

different if the outcomes were generally 

qualitative (e.g., descriptive 

information) versus quantitative (e.g., a 

numerical rating)? 

8. What other feedback would you 

like the FDA to consider for a voluntary 

QMM program? 

III. References 

The following references are on 

display with 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; these are not available 

electronically at https://

www.regulations.gov as these references 

are copyright protected. Some may be 

available at the website address, if 

listed. FDA has verified the website 

addresses, as of the date this document 

publishes in the Federal Register, but 

websites are subject to change over time. 

1. Maguire, J., A. Fisher, D. Harouaka, N. 

Rakala, et al., 2023, ‘‘Lessons from 

CDER’s Quality Management Maturity 

Pilot Programs,’’ The AAPS Journal, 

25(14), January 10, 2023, https://doi.org/ 

10.1208/s12248-022-00777-z. 

2. Fellows, M., T. Friedli, Y. Li, J. Maguire, 

et al., 2022, ‘‘Benchmarking the Quality 

Practices of Global Pharmaceutical 

Manufacturing to Advance Supply Chain 

Resilience,’’ The AAPS Journal, 24(111), 

October 20, 2022, https://doi.org/ 

10.1208/s12248-022-00761-7. 

Dated: September 12, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20015 Filed 9–14–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–4060] 

Medical Devices With Indications 

Associated With Weight Loss 

Guidances; Draft Guidances for 

Industry and Food and Drug 

Administration Staff; 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 two draft 

guidances entitled ‘‘Medical Devices 

with Indications Associated with 

Weight Loss—Clinical Study and 

Benefit-Risk Considerations’’ and 

‘‘Medical Devices with Indications 

Associated with Weight Loss—NonClinical Recommendations.’’ These draft 

guidance documents provide 

recommendations regarding clinical 

study design for devices with 

indications for use associated with 

weight loss, include discussion on how 

FDA considers the benefit-risk analysis 

to support such indications, and 

provide recommendations for the nonclinical testing to support premarket 

submissions for these medical devices. 

These draft guidances are not final nor 

are they for implementation at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 14, 2023 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: 

• 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– 

2019–N–4060 for ‘‘Medical Devices with 

Indications Associated with Weight 

Loss—Clinical Study and Benefit-Risk 

Considerations’’ and ‘‘Medical Devices 

with Indications Associated with 

Weight Loss—Non-Clinical 

Recommendations.’’ 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 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
63590 Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices 

‘‘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)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Medical Devices 

with Indications Associated with 

Weight Loss—Clinical Study and 

Benefit-Risk Considerations’’ or 

‘‘Medical Devices with Indications 

Associated with Weight Loss—NonClinical Recommendations’’ to the 

Office of Policy, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

April Marrone, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2604, Silver Spring, 

MD 20993–0002, 240–402–6510. 

SUPPLEMENTARY INFORMATION: 

I. Background 

These draft guidance documents 

provide recommendations regarding 

clinical study design for devices with 

indications for use associated with 

weight loss, include discussion on how 

FDA considers the benefit-risk analysis 

to support such indications, and 

provide recommendations for nonclinical testing to support premarket 

submissions for these medical devices. 

These devices may be indicated for 

weight loss, weight reduction, weight 

management, or obesity treatment in 

patients who are overweight or have 

obesity. The recommendations and 

considerations reflect current review 

practices and are intended to promote 

consistency and facilitate efficient 

review of these submissions. 

Prior to drafting these guidances, FDA 

requested public comment on a concept 

for balancing the benefit of weight loss 

with the risks of adverse events in a 

discussion paper (September 2019, 

Docket No. FDA–2019–N–4060). FDA 

considered public comments and 

incorporated the feedback as 

appropriate in developing the draft 

guidance, ‘‘Medical Devices with 

Indications Associated with Weight 

Loss—Clinical Study and Benefit-Risk 

Considerations.’’ 

These draft guidances are being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). These draft guidance 

documents, when finalized, will 

represent the current thinking of FDA 

on ‘‘Medical Devices with Indications 

Associated with Weight Loss—Clinical 

Study and Benefit-Risk Considerations’’ 

and ‘‘Medical Devices with Indications 

Associated with Weight Loss—NonClinical Recommendations.’’ They do 

not establish any rights for any person 

and are 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. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance document is also available at 

https://www.regulations.gov or https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Persons unable to download an 

electronic copy of ‘‘Medical Devices 

with Indications Associated with 

Weight Loss—Clinical Study and 

Benefit-Risk Considerations (document 

number GUI00021016)’’ or ‘‘Medical 

Devices with Indications Associated 

with Weight Loss—Non-Clinical 

Recommendations (document number 

GUI00019046)’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number and complete title to identify 

the guidance you are requesting. 

III. Paperwork Reduction Act of 1995 

While this guidance contains no new 

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 the following table have 

been approved by OMB: 

21 CFR part or guidance Topic OMB 

control No. 

807, subpart E ................................................................. Premarket notification ........................................................................... 0910–0120 

814, subparts A through E .............................................. Premarket approval ............................................................................... 0910–0231 

812 ................................................................................... Investigational Device Exemption ......................................................... 0910–0078 

860, subpart D ................................................................. De Novo classification process ............................................................. 0910–0844 

‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’’.Q-Submissions and Early Payor Feedback Request Programs for 

Medical Devices.

0910–0756 

800, 801, 809, and 830 ................................................... Medical Device Labeling Regulations; Unique Device Identification .... 0910–0485 

820 ................................................................................... Current Good Manufacturing Practice (CGMP); Quality System (QS) 

Regulation.

0910–0073 

50, 56 ............................................................................... Protection of Human Subjects: Informed Consent; Institutional Review Boards.0910–0130 

58 ..................................................................................... Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies.0910–0119 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices 63591 

Dated: September 12, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20029 Filed 9–14–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Change in Federal Award Closeout 

Provisions 

AGENCY: Office of the Assistant 

Secretary for Financial Resources 

(ASFR), Department of Health and 

Human Services (HHS or the 

Department). 

ACTION: Notice. 

SUMMARY: HHS will follow the Federal 

award Office of Management and 

Budget (OMB) closeout provisions 

modified the closeout provisions rather 

than the HHS-specific closeout 

provisions. 

FOR FURTHER INFORMATION CONTACT: 

Johanna Nestor at Johanna.Nestor@

hhs.gov or (202) 631–0420. 

SUPPLEMENTARY INFORMATION: 

Background: In 2014, HHS codified 

the Uniform Administrative 

Requirements, Cost Principles, and 

Audit Requirements (UAR) for HHS 

Awards at 45 CFR part 75. 79 FR 75889 

(Dec. 19, 2014). This codification 

included HHS-specific language, 

including the adoption of the closeout 

provisions at 45 CFR 75.381. In 2020, 

the Office of Management and Budget 

modified the closeout provisions for 

Federal awards at 2 CFR 200.344. 85 FR 

49506 (Aug. 13, 2020). These 

modifications: 

• Increase the number of days for 

recipients to submit closeout reports 

and liquidate all financial obligations 

from 90 calendar days to 120 calendar 

days after the end of the period of 

performance. 

• Require awarding agencies to 

complete closeout actions no later than 

one year after the end of the period of 

performance unless otherwise directed 

by authorizing statutes. 

• Require awarding agencies to close 

out awards within one year of the end 

of the period of performance based on 

available information and report the 

recipient to the OMB-designated 

integrity and performance system 

(currently Federal Awardee 

Performance and Integrity Information 

System (FAPIIS)). 

The HHS-specific closeout provisions 

at 45 CFR 75.381 are more restrictive 

than 2 CFR 200.344 as modified. This 

may lead to recipient confusion and 

inconsistencies in closeout timing 

government-wide. Additionally, the 

different provisions may result in report 

submission delays, which can affect 

closeout task reconciliation and 

effective completion. Adhering to the 2 

CFR 200.344 closeout provisions would 

provide more time for recipient 

compliance and conform with other 

Federal awarding agencies, thus 

promoting greater equity and fairness. 

Action: For the reasons stated above, 

effective October 1, 2023, HHS will 

follow the 2 CFR 200.344 closeout 

provisions This action will minimize 

the burden on the internal and external 

grants communities while ensuring the 

timely closeout of HHS awards. 

William D. Bell IV, 

Deputy Assistant Secretary for Grants. 

[FR Doc. 2023–19954 Filed 9–14–23; 8:45 am] 

BILLING CODE 4150–24–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities Comment Request 

In compliance with section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 concerning 

opportunity for public comment on 

proposed collections of information, the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

will publish periodic summaries of 

proposed projects. To request more 

information on the proposed projects or 

to obtain a copy of the information 

collection plans, call the SAMHSA 

Reports Clearance Officer at (240) 276– 

0361. 

Comments are invited on: (a) whether 

the proposed collections of information 

are necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Proposed Project: National Substance 

Use and Mental Health Services Survey 

(N–SUMHSS) (OMB No. 0930–0386)— 

Revision 

Under section 505 of the Public 

Health Service Act (42 U.S.C. 290aa–4), 

SAMHSA is required to conduct annual 

collection of data on substance use and 

mental health. Selected information 

collected from the N–SUMHSS is also 

published on SAMHSA’s 

FindTreatment.gov for persons seeking 

treatment for mental and substance use 

disorders in the United States. 

FindTreatment.gov is authorized by the 

21st Century Cures Act (Pub. L. 114– 

255, section 9006; 42 U.S.C. 290bb– 

36d). 

In 2021, SAMHSA combined the 

National Survey of Substance Abuse 

Treatment Services (N–SSATS) and the 

National Mental Health Services Survey 

(N–MHSS) into the N–SUMHSS to 

reduce the burden on facilities offering 

both substance use and mental health 

services, optimize government resources 

to collect data, and enhance the quality 

of data collected on the treatment 

facilities. 

The N–SUMHSS is the most 

comprehensive national source of data 

on substance use and mental health 

treatment facilities. On an annual basis, 

the N–SUMHSS collects information on 

the facility location, characteristics, and 

utilization of substance use and mental 

health treatment services. The survey 

also collects client counts on 

individuals receiving services at these 

facilities. There is an increasing need to 

collect and maintain data on current 

and accurate numbers of clients in 

treatment at the local level for 

communities to assess capacity and 

estimate resource requirements. This 

information on substance use and 

mental health services has assisted with 

communities to better respond to life 

changing events, (i.e., hurricane) and 

plan for service demands in the event of 

a natural disaster (i.e., earthquakes). 

SAMHSA also maintains the 

Inventory of Substance Use and Mental 

Health Treatment Facilities (I–TF) 

(previously known as the Inventory of 

Behavioral Health Services [I–BHS]). 

The I–TF is a master list of all known 

substance use and mental health 

treatment facilities in the United States. 

It also serves as the universe population 

for the N–SUMHSS. 

SAMHSA is requesting OMB approval 

of revisions to the N–SUMHSS and I–TF 

related data collections, to include 

changes to the following instruments: 

N–SUMHSS Questionnaire 

• Q1a: added to clarify if facilities 

reported providing mental health 

treatment services in Q1 also provide 

substance use treatment services, to 

help respondents understand how to 

respond accurately and ensure 

appropriate survey module(s) are 

completed. 


ddrumheller on DSK120RN23PROD with NOTICES1