Federal Register / Vol. 89, No. 18 / Friday, January 26, 2024 / Notices 5239 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Primary care providers ...................... Provider survey ................................ 40 1 10/60 7 

Men ages 55–69 ............................... Patient eligibility screener ................ 900 1 8/60 120 

Men ages 55–69 ............................... Pre-exposure survey ........................ 900 1 20/60 300 

Men ages 55–69 ............................... Post-exposure survey ...................... 900 1 20/60 300 

Men ages 55–69 ............................... Post-clinic survey ............................. 300 1 18/60 90 

Men ages 55–69 ............................... Usability survey ................................ 30 1 20/60 10 

Men ages 55–69 ............................... User experience interview ................ 900 1 20/60 300 

Clinic coordinators ............................ Clinic coordinator interview .............. 4 1 30/60 2 

Total ........................................... ........................................................... ........................ ........................ ........................ 1,129 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Public Health Ethics and 

Regulations, Office of Science, Centers for 

Disease Control and Prevention. 

[FR Doc. 2024–01550 Filed 1–25–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10887] 

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 

March 26, 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: lll, 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–10887 The Medicare 

Advantage and Prescription Drug 

Programs: Part C and Part D Medicare 

Advantage Prescription Drug (MARx) 

System Updates for the Medicare 

Prescription Payment Plan Program 

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: New collection (Request for a 

new OMB control number); Title of 

Information Collection: The Medicare 

Advantage and Prescription Drug 

Programs: Part C and Part D Medicare 

Advantage Prescription Drug (MARx) 

System Updates for the Medicare 

Prescription Payment Plan Program; 

Use: The IRA amended the Act by 

adding section 1860D–2(b)(2)(E) which, 

beginning January 1, 2025, establishes 

the Medicare Prescription Payment Plan 

program (hereinafter referred to as the 

‘‘program’’). Under this program, MA 

Organizations offering Part D coverage 

and Part D sponsors (collectively ‘‘Part 

D plans’’ or ‘‘Plans’’) are required to 

offer enrollees the option to pay their 

Part D cost sharing in monthly amounts 

spread out over the plan year based on 

the formulae described in section 

1860D–2(b)(2)(E)(iv) of the Act. 


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5240 Federal Register / Vol. 89, No. 18 / Friday, January 26, 2024 / Notices 

To effectively monitor the program, 

Part D plans will be required to report 

data elements related to the program at 

the beneficiary, contract, and Plan 

Benefit Package (PBP)1 levels beginning 

in Contract Year (CY) 2025. In this 

information collection package, CMS 

addresses the proposal to require Part D 

plans to submit beneficiary-level data 

elements into the MARx system via a 

program-specific transaction (separate 

from the enrollment file). In accordance 

with the Plan Communication User 

Guide (PCUG), plans may submit 

multiple transaction files during any 

CMS business day, Monday through 

Friday. Plan transactions are processed 

as received; there is no minimum or 

maximum limit to the number of files 

that Plans may submit in a day. In 

general, transaction and processing 

occur throughout the Current Calendar 

Month (CCM). For CY 2025, CMS will 

not require independent data validation 

for this new MARx reporting 

requirement. Form Number: CMS– 

10887 (OMB control number: 0938- 

New); Frequency: Monthly; Affected 

Public: Private, Federal Government, 

Business or other for profits, Not-forprofits institutions; Number of 

Respondents: 856; Total Annual 

Responses: 3,200,856; Total Annual 

Hours: 59,958. (For policy questions 

regarding this collection contact 

Michael Brown at (872) 287–1370 or 

michael.brown3@cms.hhs.gov.) 

Dated: January 23, 2024. 

William N. Parham, III 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–01582 Filed 1–25–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–3768] 

Best Practices for Food and Drug 

Administration Staff in the 

Postmarketing Safety Surveillance of 

Human Drug and Biological Products; 

Final Document; 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 final 

document entitled ‘‘Best Practices for 

FDA Staff in the Postmarketing Safety 

Surveillance of Human Drug and 

Biological Products.’’ The 21st Century 

Cures Act (Cures Act), enacted on 

December 13, 2016, requires that FDA 

make publicly available on its internet 

website best practices for certain 

postmarketing drug safety surveillance 

activities. This final document sets forth 

risk-based principles for FDA’s conduct 

of ongoing postmarketing safety 

surveillance for human drug products 

and human biological products, in part, 

to address the Cures Act requirements. 

This document finalizes the draft 

document entitled ‘‘Best Practices in 

Drug and Biological Product Postmarket 

Safety Surveillance for FDA Staff’’ that 

was issued on November 7, 2019. 

DATES: The announcement of the final 

document is published in the Federal 

Register on January 26, 2024. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2019–N–3768 for ‘‘Best Practices for 

FDA Staff in the Postmarketing Safety 

Surveillance of Human Drug and 

Biological 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 this document to the Division 

of Drug Information, Center for Drug 


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