Federal Register / Vol. 88, No. 240 / Friday, December 15, 2023 / Notices 86905 

purposes of publication in the Federal 

Register. 

Dated: December 12, 2023. 

Vanessa Garcia, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2023–27551 Filed 12–14–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–304/–304a, 

CMS–368/–R–144, and CMS–10249] 

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 

(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 

February 13, 2024. 

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–304/–304a Reconciliation of 

State Invoice (ROSI) (CMS–304) and 

Prior Quarter Adjustment Statement 

(PQAS) (CMS–304a) 

CMS–368/–R–144 State Agency 

Contact Form (CMS–368) and 

Quarterly State Invoice (CMS–R–144) 

CMS–10249 Administrative 

Requirements for Section 6071 of the 

Deficit Reduction Act 

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: Reconciliation 

of State Invoice (ROSI) and Prior 

Quarter Adjustment Statement (PQAS); 

Use: Form CMS–304 (ROSI) is used by 

manufacturers to respond to the state’s 

rebate invoice for current quarter 

utilization. Form CMS–304a (PQAS) is 

required only in those instances where 

a change to the original rebate data 

submittal is necessary. Form Number: 

CMS–304 and –304a (OMB control 

number: 0938–0676); Frequency: 

Quarterly; Affected Public: Private 

sector (business or other for-profits); 

Number of Respondents: 749; Total 

Annual Responses: 5,841; Total Annual 

Hours: 248,584. (For policy questions 

regarding this collection contact Robert 

Giles at 667–290–8626.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Medicaid Drug 

Rebate Program State Reporting Forms; 

Use: Form CMS 368 is a report of 

contact for the State to name the 

individuals involved in the Medicaid 

Drug Rebate Program (MDRP) and is 

required only in those instances where 

a change to the originally submitted 

data is necessary. The ability to require 

the reporting of any changes to these 

data is necessary to the efficient 

operation of these programs. Form 

CMS–R–144 is required from States 

quarterly to report utilization for any 

drugs paid for during that quarter. Form 

Number: CMS–368 and –R–144 (OMB 

control number: 0938–0582); Frequency: 

Quarterly and on occasion; Affected 

Public: State, local, or Tribal 

governments; Number of Respondents: 

56; Total Annual Responses: 290; Total 

Annual Hours: 13,669. (For policy 

questions regarding this collection 

contact Robert Giles at 667–290–8626.) 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Administrative 

Requirements for Section 6071 of the 

Deficit Reduction Act; Use: State 

Operational Protocols should provide 

enough information such that: the CMS 

Project Officer and other Federal 

officials may use it to understand the 

operation of the demonstration, prepare 

for potential site visits without needing 

additional information, or both; the 

State Project Director can use it as the 

manual for program implementation; 

and external stakeholders may use it to 

understand the operation of the 

demonstration. The financial 


ddrumheller on DSK120RN23PROD with NOTICES1
86906 Federal Register / Vol. 88, No. 240 / Friday, December 15, 2023 / Notices 

information collection is used in our 

financial statements and shared with the 

auditors who validate CMS’ financial 

position. The Money Follows the Person 

Rebalancing Demonstration (MFP) 

Finders File, MFP Program Participation 

Data file, and MFP Services File are 

used by the national evaluation 

contractor to assess program outcomes 

while we use the information to monitor 

program implementation. The MFP 

Quality of Life data is used by the 

national evaluation contractor to assess 

program outcomes. The evaluation is 

used to determine how participants’ 

quality of life changes after transitioning 

to the community. The semi-annual 

progress report is used by the national 

evaluation contractor and CMS to 

monitor program implementation at the 

grantee level. Form Number: CMS– 

10249 (OMB control number: 0938– 

1053); Frequency: Yearly, quarterly, and 

semi-annually; Affected Public: State, 

local, or Tribal governments; Number of 

Respondents: 41; Total Annual 

Responses: 410; Total Annual Hours: 

4,326. (For policy questions regarding 

this collection contact Alicia Ryce at 

410–786–1075.) 

Dated: December 12, 2023. 

William N. Parham, III 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–27614 Filed 12–14–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3369] 

Adam Michael Nagy: Final Debarment 

Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) debarring 

Adam Michael Nagy for a period of 15 

years from importing or offering for 

import any drug into the United States. 

FDA bases this order on a finding that 

Mr. Nagy was convicted of three 

relevant felony counts under Federal 

law. The factual basis supporting Mr. 

Nagy’s conviction, as described below, 

is conduct relating to the importation 

into the United States of a drug or 

controlled substance. Mr. Nagy was 

given notice of the proposed debarment 

and was given an opportunity to request 

a hearing to show why he should not be 

debarred. As of October 22, 2023 (30 

days after receipt of the notice), Mr. 

Nagy had not responded. Mr. Nagy’s 

failure to respond and request a hearing 

constitutes a waiver of his right to a 

hearing concerning this matter. 

DATES: This order is effective December 

15, 2023. 

ADDRESSES: Any application by Mr. 

Nagy for termination of debarment 

under section 306(d)(1) of the FD&C Act 

(21 U.S.C. 335a(d)(1)) may be submitted 

as follows: 

Electronic Submissions 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

An application submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

application will be made public, you are 

solely responsible for ensuring that your 

application 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 

application, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit an 

application with confidential 

information that you do not wish to be 

made available to the public, submit the 

application as a written/paper 

submission and in the manner detailed 

(see ‘‘Written/Paper Submissions’’ and 

‘‘Instructions’’). 

Written/Paper Submissions 

• 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 a written/paper application 

submitted to the Dockets Management 

Staff, FDA will post your application, as 

well as any attachments, except for 

information submitted, marked, and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All applications must 

include the Docket No. FDA–2023–N– 

3369. Received applications 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 an application with confidential 

information that you do not wish to be 

made publicly available, submit your 

application 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 your application. 

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. 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, 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 between 9 a.m. 

and 4 p.m., Monday through Friday. 

Publicly available submissions may be 

seen in the docket. 

FOR FURTHER INFORMATION CONTACT: 

Jaime Espinosa, Division of Compliance 

and Enforcement, Office of Policy, 

Compliance, and Enforcement, Office of 

Regulatory Affairs, Food and Drug 

Administration, at 240–402–8743, or 

debarments@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(1)(D) of the FD&C Act 

(21 U.S.C. 335a(b)(1)(D)) permits 

debarment of an individual from 

importing or offering for import any 

drug into the United States if the FDA 

finds, as required by section 306(b)(3)(C) 

of the FD&C Act, that the individual has 

been convicted of a felony for conduct 

relating to the importation into the 

United States of any drug or controlled 

substance. 

On May 1, 2023, Mr. Nagy was 

convicted, as defined in section 

306(l)(1) of FD&C Act, in the U.S. 

District Court for the Western District of 

Pennsylvania, when the court entered 

judgment against him for multiple 


ddrumheller on DSK120RN23PROD with NOTICES1