Federal Register / Vol. 88, No. 174 / Monday, September 11, 2023 / Notices 62377 

d. date of birth (required) 

e. gender (required) 

f. social security number (SSN) 

(required) 

g. requested qualified health plan (QHP) 

coverage effective date (required) 

h. requested QHP coverage end date 

(required) 

i. State identification (required) 

j. transaction ID (required) 

Data provided by VHA to CMS: 

a. SSN (required) 

b. start/end date(s) of enrollment 

period(s) (when match occurs) 

c. a blank date response when a nonmatch occurs 

d. a blank date when a match is made 

but VHA’s record contains a date of 

death 

e. enrollment period(s) is/are defined as 

the timeframe during which the 

individual was enrolled in a VHA 

Health Care Program. 

System(s) of Records 

The records used in the matching 

program will be disclosed from the 

following systems of records, as 

authorized by routine uses published in 

the system of records notices (SORNs) 

cited below: 

A. System of Records Maintained by 

CMS 

CMS Health Insurance Exchanges 

System (HIX), CMS System No. 09–70– 

0560, last published in full at 78 FR 

63211 (Oct. 23, 2013), as amended at 83 

FR 6591 (Feb. 14, 2018). Routine use 3 

authorizes CMS’ disclosures to VHA. 

B. Systems of Records Maintained by 

VHA 

54VA10NB3 Veterans and 

Beneficiaries Purchased Care 

Community Health Care Claims, 

Correspondence, Eligibility, Inquiry and 

Payment Files—VA, published at 80 FR 

11527 (March 3, 2015). Routine use 25 

authorizes VHA’s disclosures to CMS. 

[FR Doc. 2023–19481 Filed 9–8–23; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–R–21 and 

CMS–8003] 

Agency Information Collection 

Activities: Proposed Collection; 

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 (the 

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 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates 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 must be received by 

November 13, 2023. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number: ll, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

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 N. Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–R–21 Withholding Medicare 

Payments to Recover Medicaid 

Overpayments and Supporting 

Regulations in 42 CFR 447.31 

CMS–8003 1915(c) Home and 

Community Based Services (HCBS) 

Waiver Application 

Under the 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 

requires Federal agencies to publish a 

60-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. 

Information Collection 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Withholding 

Medicare Payments to Recover 

Medicaid Overpayments and 

Supporting Regulations in 42 CFR 

447.31; Use: Certain Medicaid providers 

that are subject to offsets for the 

collection of Medicaid overpayments 

may terminate or substantially reduce 

their participation in Medicaid, leaving 

the State Medicaid agency unable to 

recover the amounts due. Recovery 

procedures allow for determining the 

amount of overpayments and offsetting 

the overpayments by withholding the 

provider’s Medicare payments. To 

effectuate the withholding, the State 

agency must provide their respective 

CMS regional office with certain 

documentation that identifies the 

provider and the Medicaid overpayment 

amount. The agency must also 

demonstrate that the provider was 

notified of the overpayment and that 

demand for the overpayment was made. 

An opportunity to appeal the 

overpayment determination must be 


ddrumheller on DSK120RN23PROD with NOTICES1
62378 Federal Register / Vol. 88, No. 174 / Monday, September 11, 2023 / Notices 

afforded to the provider by the Medicaid 

State agency. Lastly, Medicaid State 

agencies must notify CMS when to 

terminate the withholding; Form 

Number: CMS–R–21 (OMB control 

number: 0938–0287); Frequency: 

Occasionally; Affected Public: State, 

local, or Tribal governments; Number of 

Respondents: 54; Total Annual 

Responses: 27; Total Annual Hours: 81. 

(For policy questions regarding this 

collection contact Stuart Goldstein at 

410–786–0694.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: 1915(c) Home 

and Community-Based Services (HCBS) 

Waiver Application; Use: We use the 

application to review and adjudicate 

individual waiver actions. The 

application is also used by States to 

submit and revise their waiver requests. 

Form Number: CMS–8003 (OMB control 

number 0938–0449); Frequency: Yearly; 

Affected Public: State, local, or Tribal 

governments; Number of Respondents: 

47; Total Annual Responses: 71; Total 

Annual Hours: 6,005. (For policy 

questions regarding this collection 

contact Ryan Shannahan at 410–786– 

0295.) 

Dated: September 6, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–19500 Filed 9–8–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–3391] 

Clinical Pharmacology Considerations 

for Peptide Drug Products; Draft 

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 draft 

guidance for industry entitled ‘‘Clinical 

Pharmacology Considerations for 

Peptide Drug Products.’’ This guidance 

describes FDA’s recommendations 

regarding clinical pharmacology 

considerations for peptide drug product 

development programs, including 

hepatic impairment, drug-drug 

interactions (DDIs), assessing QTc 

prolongation risk, and immunogenicity 

risk and impact on the 

pharmacokinetics (PK), safety, and 

efficacy assessment. The intent of this 

draft guidance, when finalized, is to 

assist industry in the conduct of these 

development programs. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 11, 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– 

2023–D–3391 for ‘‘Clinical 

Pharmacology Considerations for 

Peptide Drug Products.’’ 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 

‘‘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 the draft 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 draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Daphne Guinn, Center for Drug 


ddrumheller on DSK120RN23PROD with NOTICES1