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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 18 / Friday, January 26, 2024 / Notices 5241 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002 or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, 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 document. 

FOR FURTHER INFORMATION CONTACT: Sara 

Camilli, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 3486, Silver Spring, 

MD 20993–0002, 301–796–4203, 

Sara.Camilli@fda.hhs.gov; or James 

Myers, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA 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.’’ 

Title IX, section 915 of the Food and 

Drug Administration Amendments Act 

of 2007 (FDAAA) (Pub. L. 110–85) 

added section 505(r) to the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 355(r)), requiring FDA to 

prepare a summary analysis of the 

adverse drug reaction reports received 

for a drug by 18 months after approval 

or after use of the drug by 10,000 

individuals, whichever is later. The 

analysis includes identification of any 

new risks not previously identified, 

potential new risks, or known risks 

reported in unusual number. 

Section 3075 of the Cures Act (Pub. L. 

114–255) amended section 505(r)(2)(D) 

of the FD&C Act to eliminate the 

requirement for summary analyses for 

drugs as required by FDAAA. In place 

of the summary analyses, section 3075 

amended section 505(r)(2)(D) of the 

FD&C Act to include the requirement 

that FDA make publicly available on its 

internet website best practices for drug 

safety surveillance activities for drugs 

approved under section 505 of the FD&C 

Act or section 351 of the Public Health 

Service Act (PHS Act). 

Section 3075 of the Cures Act also 

amended section 505(k)(5) of the FD&C 

Act to strike ‘‘bi-weekly screening,’’ in 

subparagraph (A), and insert 

‘‘screenings’’; it also added the 

requirement that FDA make publicly 

available on its internet website 

guidelines, developed with input from 

experts qualified by scientific training 

and experience to evaluate the safety 

and effectiveness of drugs, that detail 

best practices for drug safety 

surveillance using the Adverse Event 

Reporting System. 

The final document entitled ‘‘Best 

Practices for FDA Staff in the 

Postmarketing Safety Surveillance of 

Human Drugs and Biological Products’’ 

sets forth risk-based principles for 

FDA’s conduct of ongoing 

postmarketing safety surveillance for 

human drug products and human 

biological products to address the Cures 

Act requirements. Although section 

3075 of the Cures Act only references 

drugs approved under section 505 of the 

FD&C Act or section 351 of the PHS Act, 

the document additionally discusses 

other products, including 

nonprescription drug products, 

compounded drug products, and 

homeopathic products. The document 

also includes a high-level overview of 

other drug safety surveillance data 

sources, tools, methods, and activities 

that extend beyond use of FDA’s 

adverse event reporting systems, as well 

as regulatory and other actions that can 

be taken in response to identified safety 

signals. These additional topics are 

included to provide context and a 

general overview of FDA’s safety 

surveillance process. 

This document finalizes the draft 

document entitled ‘‘Best Practices in 

Drug and Biological Product Postmarket 

Safety Surveillance for FDA Staff,’’ 

issued on November 7, 2019 (84 FR 

60094). FDA considered comments 

received on the draft document as the 

document was finalized. Changes from 

the draft to the final document include: 

(1) document title revised to emphasize 

this document’s focus on postmarketing 

safety surveillance and to clarify that 

this document only refers to human 

drug and biological products that are 

regulated by FDA, as this document 

does not refer to animal drugs regulated 

by FDA; (2) additional content to 

distinguish between the use of the terms 

adverse event and adverse reaction; (3) 

clarification of products that generally 

are subject to more extensive monitoring 

and types of safety information for 

focus; (4) addition of a description of 

the FDA Adverse Event Reporting 

System Public Dashboard; (5) revisions 

to the content on medication errors, for 

clarity; (6) revisions to the section on 

the pregnant population to align with 

the most recently issued documents 

pertaining to clinical trials and 

postapproval pregnancy safety studies; 

(7) inclusion of citations referencing the 

Sentinel System; (8) revisions to the 

description of the process for signal 

evaluation and documentation, 

including addition of a reference to the 

Center for Drug Evaluation and 

Research’s ‘‘Manual of Policies and 

Procedures for Collaborative 

Identification, Evaluation, and 

Resolution of a Newly Identified Safety 

Signal’’; (9) inclusion of an expanded 

discussion of product labeling changes; 

and (10) additional content regarding 

Drug Safety Communications. Editorial 

changes were made to improve clarity. 

II. Electronic Access 

Persons with access to the internet 

may obtain the document at https://

www.fda.gov/about-fda/center-drugevaluation-and-research-cder/cderoffice-surveillance-and-epidemiology or 

https://www.regulations.gov. 

Dated: January 23, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01584 Filed 1–25–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2853] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Recordkeeping 

and Reporting Requirements for 

Human Food and Cosmetics 

Manufactured From, Processed With, 

or Otherwise Containing Material From 

Cattle 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by February 

26, 2024. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 


lotter on DSK11XQN23PROD with NOTICES1