Federal Register / Vol. 89, No. 37 / Friday, February 23, 2024 / Notices 13721 

(OMB control number: 0938–0599); 

Frequency: Yearly, quarterly, and semiannually; Affected Public: State, Local, 

or Tribal Governments; Number of 

Respondents: 50; Total Annual 

Responses: 50; Total Annual Hours: 34. 

(For policy questions regarding this 

collection contact Eric Powell at 312– 

886–0791.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–03675 Filed 2–22–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10164 A/B] 

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 

April 23, 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: , 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–10164 A/B Medicare Electronic 

Data Interchange (EDI) Registration and 

Electronic Data Interchange Enrollment 

Form 

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: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Medicare 

Electronic Data Interchange (EDI) 

Registration and Electronic Data 

Interchange Enrollment Form; Use: The 

purpose of this collection is to obtain 

information that will be subsequently 

used during transaction exchange for 

identification of Medicare providers/ 

suppliers and authorization of requested 

electronic data interchange (EDI) 

functions. The EDI Registration Form 

and the Medicare Enrollment Forms are 

completed by Medicare providers/ 

suppliers and submitted to CMS 

Medicare Administrative Contractors 

(MACs). Authorization is needed for 

providers/suppliers to send/receive 

Health Insurance Portability and 

Accountability Act (HIPAA) standard 

transactions directly (or through a 

designated 3rd party) to/from Medicare 

contractors. Medicare contractors will 

use the information for initial set-up 

and maintenance of the access 

privileges. CMS has allowed each MAC 

to create their own organization specific 

forms given they are comparable in 

terms of content of forms 10164A and 

10164B, to transmit data files 

electronically between themselves and 

their trading partners. The Standards for 

Electronic Transactions final rule, 45 

CFR part 162 subpart K § 162.1101 

through subpart R § 162.1802, 

(hereinafter referred to as ‘‘Transactions 

Rule’’) published August 17, 2000, 

adopted standards for health care 

transactions and code sets. Subsequent 

to the Transactions Rule, CMS–0003–P 

and CMS–0005–P proposed 

modifications to the adopted standards 

essential to permit initial 

implementation of the standards 

throughout the entire healthcare 

industry. Currently, MACs have a 

process in place to enroll providers for 

electronic billing and other EDI 

transactions. In support of the HIPAA 

Transactions Rule, the purpose of this 

Paperwork Reduction Act (PRA) request 

is to establish a prescribed amount of 

data that must be submitted by 

providers/suppliers that is sufficient to 

address all HIPAA transactions. Form 

Number: CMS–10164 A/B (OMB control 

number: 0938–0983); Frequency: Once; 

Affected Public: Private and Business or 

other for-profits; Number of 

Respondents: 1,181,209; Number of 

Responses: 1,181,209; Total Annual 

Hours: 393,706. (For policy questions 

regarding this collection contact 


ddrumheller on DSK120RN23PROD with NOTICES1
13722 Federal Register / Vol. 89, No. 37 / Friday, February 23, 2024 / Notices 

Charlene Parks at (410)-786–8684 or 

Charlene.Parks@cms.hhs.gov). 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–03676 Filed 2–22–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2113] 

Taylor McLaren: Final Debarment 

Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

issuing an order under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) debarring Taylor McLaren for a 

period of 5 years from importing or 

offering for import any drug into the 

United States. FDA bases this order on 

a finding that Mr. McLaren was 

convicted of one felony count under 

Federal law for conspiracy to smuggle 

goods into the United States. The factual 

basis supporting Mr. McLaren’s 

conviction, as described below, is 

conduct relating to the importation into 

the United States of a drug or controlled 

substance. Mr. McLaren 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 January 8, 2024 (30 days 

after receipt of the notice), Mr. McLaren 

had not responded. Mr. McLaren’s 

failure to respond and request a hearing 

constitutes a waiver of his right to a 

hearing concerning this matter. 

DATES: This order is applicable February 

23, 2024. 

ADDRESSES: Any application by Mr. 

McLaren 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– 

2113. 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, 240–402–7500, 

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 

permits debarment of an individual 

from importing or offering for import 

any drug into the United States if 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 March 2, 2023, Mr. McLaren was 

convicted as defined in section 306(l)(1) 

of the FD&C Act, in the U.S. District 

Court for Western District of Michigan 

when the court accepted his plea of 

guilty and entered judgment against him 

for the offense of conspiracy to smuggle 

goods into the United States in violation 

of 18 U.S.C. 371 and 545. 

The underlying facts supporting the 

conviction are as follows: As contained 

in the indictment and plea agreement 

from his case, filed on March 1, 2022, 

and August 22, 2022, respectively, 

Brendon Gagne owned and operated 

www.ExpressPCT.com, which sold 

misbranded prescription drugs, 

obtained from overseas suppliers, and 

sold to customers in the United States 

without requiring a prescription. Mr. 

McLaren was recruited by Brendon 

Gagne to receive, repackage, and reship 

prescription drugs Mr. McLaren 

received from co-conspirators outside of 

the United States that were purchased 

by customers on the website 

www.ExpressPCT.com. In Mr. 

McLaren’s plea agreement, he 

acknowledged he knew that receiving 

and reshipping prescription drugs in 

this manner was illegal. Later on, Mr. 

McLaren recruited at least one other 

person to be involved in the scheme by 


ddrumheller on DSK120RN23PROD with NOTICES1