57462 Federal Register / Vol. 88, No. 162 / Wednesday, August 23, 2023 / Notices 

2,304,450; Number of Responses: 

2,304,450; Total Annual Hours: 282,366. 

(For policy questions regarding this 

collection, contact William G. Lehrman 

at 410–786–1037.) 

Dated: August 18, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–18151 Filed 8–22–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10809] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by September 22, 

2023. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, please access the CMS PRA 

website by copying and pasting the 

following web address into your web 

browser: https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/

PaperworkReductionActof1995/PRAListing. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), Federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Ambulatory 

Surgical Center Covered Procedures List 

(ASC CPL); Use: The ASC CPL 

(Ambulatory Surgical Center Covered 

Procedures List) was authorized in 

accordance with section 1833(i)(1) of 

the Social Security Act, which requires 

the Secretary to specify surgical 

procedures which are appropriately 

performed on an inpatient basis in a 

hospital but which also can be 

performed safely on an ambulatory basis 

in an ASC, critical access hospital, or 

hospital outpatient department. The 

statute also requires the Secretary to 

regularly review and update the ASC 

CPL. 

During rulemaking, CMS receives 

surgical procedure code nominations 

from a variety of external interested 

parties and evaluates them for inclusion 

to the CPL in the OPPS/ASC proposed 

rule. After reviewing the nominations 

and evaluating them against the criteria, 

CMS proposes the list of procedures that 

they will add to the CPL for the 

following calendar year. The public has 

60 days to comment on the proposals, 

CMS takes these perspectives into 

account, and the final list of procedure 

nominations are finalized in the OPPS/ 

ASC final rule. 

The information collected in this 

request will be used by CMS annually 

to determine what covered surgical 

procedures should be added to the ASC 

CPL. Specifically, the policy analysts 

and medical officers in the Division of 

Outpatient Care will individually 

review each procedure nomination, as 

well as any supporting evidence 

(clinical studies, literature, data or 

letters of support) submitted. The 

agency will use this information to 

propose a list of covered surgical 

procedures for the OPPS/ASC Proposed 

Rule starting with the CY 2025 Proposed 

Rule. Form Number: CMS–10809 (OMB 

control number: 0938–New); Frequency: 

Yearly; Affected Public: Private Sector, 

Business or other for-profits and Notfor-profit institutions; Number of 

Respondents: 15; Total Annual 

Responses: 100; Total Annual Hours: 

50. (For policy questions regarding this 

collection contact Nate Vercauteren at 

Nathan.Vercauteren@cms.hhs.gov.) 

Dated: August 18, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–18154 Filed 8–22–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2462] 

Workshop To Enhance Clinical Study 

Diversity; Public Workshop; Request 

for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing a public workshop 

entitled ‘‘Workshop To Enhance 

Clinical Study Diversity.’’ This public 

workshop will satisfy a mandate of the 

Food and Drug Omnibus Reform Act of 

2022 (FDORA) for FDA to convene one 


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Federal Register / Vol. 88, No. 162 / Wednesday, August 23, 2023 / Notices 57463 

or more public workshops to solicit 

input from various stakeholders on 

enhancing diversity in clinical 

studies.The public workshop will be 

convened and supported by a 

cooperative agreement between FDA 

and the Clinical Trials Transformation 

Initiative and will solicit input from 

interested parties on increasing the 

enrollment of historically 

underrepresented populations in 

clinical studies and encouraging clinical 

study participation that reflects the 

prevalence or incidence of the disease 

or condition among demographic 

subgroups, where appropriate. 

DATES: The public workshop will be 

held virtually on November 29, 2023, 

from 10 a.m. to 2 p.m., Eastern Time 

and November 30, 2023, from 10 a.m. to 

2 p.m., Eastern Time. Following the 

workshop, a public comment period 

will be established to receive comments 

related to the topics addressed during 

the public workshop. Either electronic 

or written comments on this public 

workshop must be submitted by January 

29, 2024. See the SUPPLEMENTARY

INFORMATION section for registration date 

and information. 

ADDRESSES: The public workshop will 

be held virtually using the Zoom 

platform. The link for the public 

workshop will be sent to registrants 

upon registration. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

on January 29, 2024. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

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– 

2023–N–2462 for ‘‘Workshop To 

Enhance Clinical Study Diversity.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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 

‘‘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. 

FOR FURTHER INFORMATION CONTACT: Dat 

Doan, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 3334, Silver Spring, 

MD 20993, 240–402–8962, Dat.Doan@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 3603 of the FDORA requires 

FDA to convene one or more public 

workshops to solicit input from various 

stakeholders on increasing diversity in 

clinical studies. To meet the FDORA 

requirement, FDA will convene a 

workshop with key participants, 

including drug and device sponsors, 

clinical research organizations, 

academia, patients and patient 

advocates, study site investigators, and 

the public, to gather input on how to 

enhance clinical study diversity by 

discussing ways to (1) increase 

enrollment of historically 

underrepresented populations in 

clinical studies and (2) encourage 

clinical study participation that reflects 

the prevalence of the disease or 

condition among demographic 

subgroups, where appropriate. The 

public workshop scheduled for 

November 29, 2023, and November 30, 

2023, will fulfill the requirement to 

convene a public workshop no later 

than 1 year after the date of the 

enactment of FDORA. 

II. Topics for Discussion at the Public 

Workshop 

At the public workshop, FDA plans to 

solicit input from participants on 

increasing the enrollment of historically 

underrepresented populations in 

clinical studies and encouraging clinical 

study participation that reflects disease 

prevalence or incidence data, including 

but not limited to: 

1. The collection and presentation of 

disease prevalence and incidence data 

by demographic group. 


lotter on DSK11XQN23PROD with NOTICES1
57464 Federal Register / Vol. 88, No. 162 / Wednesday, August 23, 2023 / Notices 

2. The dissemination of information 

to the public on clinical study 

enrollment demographic data. 

3. The establishment of goals for 

clinical study enrollment, including the 

relevance of disease prevalence and 

incidence. 

4. The approaches to include 

underrepresented populations and 

encourage participation that reflects the 

population expected to use the drug or 

device, if approved, including: 

A. The establishment of inclusion and 

exclusion criteria for certain subgroups, 

such as pregnant and lactating women 

and individuals with disabilities, 

including intellectual or developmental 

disabilities or mental illness. 

B. The considerations regarding 

informed consent with respect to 

individuals with intellectual or 

developmental disabilities or mental 

illness, including ethical and scientific 

considerations. 

C. The appropriate use of 

decentralized trials or digital health 

tools, clinical endpoints, biomarker 

selection, and studying analysis. 

III. Participating in the Public 

Workshop 

Registration: To register for the public 

workshop, please visit the following 

website: https://duke.zoom.us/meeting/ 

register/tJcrceuhqjgvE9zGjDNOURONo

JZvxrpK4Rvi#/registration. Please 

provide complete contact information 

for each attendee, including name, title, 

affiliation, address, email, and 

telephone. 

Registration is free, and persons 

interested in attending this public 

workshop must register to receive a link 

to the meeting. Registrants will receive 

a confirmation email after they register. 

If you need special accommodations 

due to a disability, please contact 

Sabrena Mervin-Blake, 919–724–0715, 

sabrena.mervin-blake@duke.edu no 

later than November 15, 2023. Please 

note, closed captioning and American 

Sign Language will be available 

automatically. 

Dated: August 18, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–18149 Filed 8–22–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development; Notice of Closed 

Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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: Eunice Kennedy 

Shriver National Institute of Child Health 

and Human Development Special Emphasis 

Panel; PS/Member Conflict. 

Date: October 5, 2023. 

Time: 10:00 a.m. to 12:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Eunice 

Kennedy Shriver National Institute of Child 

Health and Human Development, 6710B 

Rockledge Drive, Room 2137B, Bethesda, MD 

20892 (Virtual Meeting). 

Contact Person: Vera A. Cherkasova, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Eunice Kennedy Shriver National 

Institute of Child Health, and Human 

Development National Institutes of Health, 

6710B Rockledge Drive, Room 2137B, 

Bethesda, MD 20892, (240) 478–4580, 

vera.cherkasova@nih.gov. 

Name of Committee: Eunice Kennedy 

Shriver National Institute of Child Health 

and Human Development Special Emphasis 

Panel; Ruth L. Kirschstein National Research 

Service Award (NRSA) Institutional Research 

Training Grant Review. 

Date: November 2–3, 2023. 

Time: 9:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: North Bethesda Marriott Hotel and 

Conference Center, Montgomery County 

Conference Center Facility, 5701 Marinelli 

Road, North Bethesda, MD 20852. 

Contact Person: Christiane M. Robbins, 

Scientific Review Officer, Scientific Review 

Branch, Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, National Institutes of Health, 

6710B Rockledge Drive, Room 2125D, 

Bethesda, MD 20892, (301) 451–4989, 

crobbins@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.865, Research for Mothers 

and Children, National Institutes of Health, 

HHS) 

Dated: August 18, 2023. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–18145 Filed 8–22–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; External Quality Assurance 

Program Oversight Laboratory (EQAPOL), 

RFP: 75N93022R00034. 

Date: September 15, 2023. 

Time: 1:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3G21B, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Robert C. Unfer, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, 5601 

Fishers Lane, Room 3G21B, Rockville, MD 

20852, 240–669–5035. unferrc@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: August 18, 2023. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–18147 Filed 8–22–23; 8:45 am] 

BILLING CODE 4140–01–P 


lotter on DSK11XQN23PROD with NOTICES1