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
Federal Register / Vol. 88, No. 240 / Friday, December 15, 2023 / Notices 86907 

offenses he pled guilty to, including the 

offenses of: (1) importation into the 

United States a quantity of ethylone, a 

Schedule I Controlled Substance in 

violation of 21 U.S.C. 952(a) and 

960(a)(1); (2) importation into the 

United States quantities of TURINABOL 

and DIANABOL, anabolic steroids, and 

Schedule III Controlled Substances in 

violation of 21 U.S.C. 952(b) and 

960(a)(1); and (3) smuggling goods into 

the United States, that is, alpha-PVP 

ethylone, Schedule I Controlled 

Substances, and TURINBOL and 

DIANABOL, Schedule III Controlled 

Substances, in violation of 18 U.S.C. 

545. FDA’s finding that debarment is 

appropriate is based on the felony 

conviction referenced herein. The 

factual basis for this conviction is as 

follows: 

As contained in the superseding 

indictment, filed on March 22, 2018, the 

Defendant’s motion for downward 

variance, filed on April 24, 2023, and 

the Government’s sentencing 

memorandum, filed April 24, 2023, 

from Mr. Nagy’s case, Mr. Nagy was the 

owner and operator of Prescription 

Nutrition, Prescription Protein, and 

N.O.B. Industries located in 

Pennsylvania. From on or about June 

2014 to on or about September 2014, 

Mr. Nagy imported various types of 

controlled substances which he then 

capsuled and distributed to clients. 

Specifically, from on or about June 2014 

to on or about July 2014, Mr. Nagy 

illegally imported ethylone. In July 

2014, he also illegally imported 

TURINABOL and DIANABOL. In 

addition, from June 2014 until on or 

about September 2014, Mr. Nagy 

illegally imported alpha-PVP, ethylone, 

TURINABOL, and DIANABOL. All the 

controlled substances Mr. Nagy 

imported and smuggled into the country 

came from China. 

As a result of this conviction, FDA 

sent Mr. Nagy, by certified mail, on 

September 20, 2023, a notice proposing 

to debar him for a 15-year period from 

importing or offering for import any 

drug into the United States. The 

proposal was based on a finding under 

section 306(b)(3)(C) of the FD&C Act 

that Mr. Nagy’s three felony convictions 

that included: (1) importation into the 

United States a quantity of ethylone, a 

Schedule I Controlled Substance in 

violation of 21 U.S.C. 952(a) and 

960(a)(1); (2) importation into the 

United States quantities of TURINABOL 

and DIANABOL, anabolic steroids and 

Schedule III Controlled Substances in 

violation of 21 U.S.C. 952(b) and 

960(a)(1); and (3) smuggling goods into 

the United States, that is, alpha-PVP 

ethylone, Schedule I Controlled 

Substances, and TURINBOL, 

DIANABOL, Schedule III Controlled 

Substances in violation of 18 U.S.C. 545, 

were for conduct relating to the 

importation into the United States of 

any drug or controlled substance 

because he imported controlled 

substances into the United States in 

order to capsule portions of the drugs to 

sell to clients. In proposing a debarment 

period, FDA weighed the considerations 

set forth in section 306(c)(3) of the 

FD&C Act that it considered applicable 

to Mr. Nagy’s offenses and concluded 

that each offense warranted the 

imposition of a 5-year period of 

debarment, to run consecutively, for a 

total of a 15-year period of debarment. 

The proposal informed Mr. Nagy of 

the proposed debarment and offered 

him an opportunity to request a hearing, 

providing him 30 days from the date of 

receipt of the letter in which to file the 

request, and advised him that failure to 

request a hearing constituted a waiver of 

the opportunity for a hearing and of any 

contentions concerning this action. Mr. 

Nagy received the proposal and notice 

of opportunity for a hearing on 

September 22, 2023. Mr. Nagy failed to 

request a hearing within the timeframe 

prescribed by regulation and has, 

therefore, waived his opportunity for a 

hearing and waived any contentions 

concerning his debarment (21 CFR part 

12). 

II. Findings and Order 

Therefore, the Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

306(b)(3)(C) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Adam Michael 

Nagy been convicted of three felonies 

under federal law for conduct relating to 

the importation into the United States of 

any drug or controlled substance. FDA 

finds that the offense should be 

accorded a debarment period of 15 years 

as provided by section 306(c)(2)(A)(iii) 

of the FD&C Act. 

As a result of the foregoing finding, 

Mr. Nagy is debarred for a period of 15 

years from importing or offering for 

import any drug into the United States, 

effective (see DATES). Pursuant to 

section 301(cc) of the FD&C Act (21 

U.S.C. 331(cc)), the importing or 

offering for import into the United 

States of any drug by, with the 

assistance of, or at the direction of Mr. 

Nagy is a prohibited act. 

Dated: December 11, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27557 Filed 12–14–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the National Advisory 

Council on Nurse Education and 

Practice 

AGENCY: Health Resources and Services 

Administration, Department of Health 

and Human Services. 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the National 

Advisory Council on Nurse Education 

and Practice (NACNEP) will hold public 

meetings for the 2024 calendar year 

(CY). Information about NACNEP, 

agendas, and materials for these 

meetings can be found on the NACNEP 

website at https://www.hrsa.gov/ 

advisory-committees/nursing. 

DATES: NACNEP meetings will be on (all 

in Eastern Time): 

• March 14, 2024, 10 a.m.–4 p.m. and 

March 15, 2024, 10 a.m.–4 p.m.; 

• May 9, 2024, 10 a.m.–4 p.m.; 

• August 7, 2024, 10 a.m.–4 p.m. and 

August 8, 2024, 10 a.m.–4 p.m.; and 

• December 5, 2024, 8 a.m.–5 p.m. 

and December 6, 2024, 8 a.m.–2 p.m. 

ADDRESSES: Meetings may be held in 

person, via teleconference, and/or video 

conference. In-person meetings will be 

held at 5600 Fishers Lane, Rockville, 

Maryland 20857. For updates on how 

the meeting will be held and 

instructions for joining meetings, visit 

the NACNEP website at https://

www.hrsa.gov/advisory-committees/ 

nursing/meetings 14 business days 

before the date of the meeting. 

FOR FURTHER INFORMATION CONTACT: 

Justin Bala-Hampton, Designated 

Federal Official, NACNEP, Bureau of 

Health Workforce, Division of Nursing 

and Public Health, Health Resources 

and Services Administration, 5600 

Fishers Lane, 11N100D, Rockville, 

Maryland 20857; 301–443–5260; or 

Jbala-hampton@hrsa.gov. 

SUPPLEMENTARY INFORMATION: NACNEP 

provides advice and recommendations 

to the Secretary of Health and Human 

Services on policy, program 

development, and other matters of 

significance concerning the activities 

under title VIII of the Public Health 

Service Act, including the range of 

issues relating to the nurse workforce, 

education, and practice improvement. 

NACNEP also prepares and submits an 

annual report to the Secretary of Health 

and Human Services and Congress 

describing its activities, including 


ddrumheller on DSK120RN23PROD with NOTICES1