Federal Register / Vol. 89, No. 219 / Wednesday, November 13, 2024 / Notices 89645 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN FOR THE 2025–2027 MEPS–IC 

Form name Number of 

respondents 

Total burden 

hours 

Average 

hourly wage 

rate * 

Total cost 

burden 

Prescreener Questionnaire .................................................................................... 18,900 1,575 38.76 $61,047 

Establishment Questionnaire ................................................................................. 21,900 7,300 38.76 282,948 

Plan Questionnaire ................................................................................................ 18,900 7,970 38.76 308,898 

Total ................................................................................................................ 59,700 16,845 n/a 652,893 

* Based upon the mean hourly wage for Compensation, Benefits, and Job Analysis Specialists occupation code 13–1141, at https://

www.bls.gov/oes/current/oes131141.htm (U.S. Department of Labor, Bureau of Labor Statistics.) 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, 44 U.S.C. 3501–3520, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ’s health care research and health 

care information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) of 

information; (c) ways to enhance the 

quality, utility and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: November 5, 2024. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2024–26207 Filed 11–12–24; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Objective Work Plan/OnGoing Progress Report (Office of 

Management and Budget #0970–0452) 

AGENCY: Administration for Native 

Americans, Administration for Children 

and Families, U.S. Department of Health 

and Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Administration for 

Children and Families’ (ACF) 

Administration for Native Americans 

(ANA) is requesting a 3-year extension 

to the Ongoing Progress Report (OPR) 

and the Objective Work Plan (OWP) 

(Office of Management and Budget 

#0970–0452, expiration September 30, 

2026). Changes are proposed only to the 

report. 

DATES: Comments due January 13, 2025. 

In compliance with the requirements of 

the Paperwork Reduction Act of 1995, 

ACF is soliciting public comment on the 

specific aspects of the information 

collection described above. 

ADDRESSES: You can obtain copies of the 

proposed collection of information and 

submit comments by emailing 

infocollection@acf.hhs.gov. Identify all 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: The information in the 

OPR is collected on a semi-annual basis 

to monitor the performance of grantees 

and better gauge grantee progress. 

The OPR information collection is 

conducted in accordance with sec. 811 

[42 U.S.C. 2992] of the Native American 

Programs Act and will allow ANA to 

report quantifiable results across all 

program areas. It also provides grantees 

with parameters for reporting their 

progress and helps ANA better monitor 

and determine the effectiveness of their 

projects. 

The OWP information collection is 

conducted in accordance with 42 U.S.C. 

of the Native American Programs Act of 

1972, as amended. This collection is 

necessary to evaluate applications for 

financial assistance and determine the 

relative merits of the projects for which 

such assistance is requested, as set forth 

in sec. 806 [42 U.S.C. 2991–d 1](a)(1). 

The report was revised based on a 

review by ANA and feedback from 

grantees, which identified some data 

elements that could be eliminated and 

areas that could be clarified. 

Respondents: Federally and state 

recognized tribes, Native Pacific 

Islanders, Tribal Colleges and 

Universities, native non-profits, and 

consortia. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Total 

burden 

hours 

Annual 

burden 

hours 

Objective Work Plan ................................................................ 300 1 3 900 300 

On-Going Progress Report ...................................................... 200 2 1 400 133 

Estimated Total Annual Burden 

Hours: 433. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 


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89646 Federal Register / Vol. 89, No. 219 / Wednesday, November 13, 2024 / Notices 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: Sec. 806 [42 U.S.C. 2991d– 

1](a)(1) and Sec. 811 [42 U.S.C. 2992]. 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–26230 Filed 11–12–24; 8:45 am] 

BILLING CODE 4184–34–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5057] 

Public Workshop on Optimizing the 

Use of Real-World Evidence in 

Regulatory Decision-Making for Drugs 

and Biological Products—Looking 

Forward; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing a public workshop titled 

‘‘Optimizing the Use of Real-World 

Evidence in Regulatory DecisionMaking for Drugs and Biological 

Products—Looking Forward.’’ The 

purpose of the public workshop is to 

provide interested parties with an 

update on FDA’s current activities 

related to real-world evidence (RWE) 

and to share accomplishments, ongoing 

challenges, and future opportunities. 

The public workshop will discuss 

potential next steps to promote the 

continued evolution and consistent 

application of real-world data (RWD) in 

drug development. This public 

workshop will be convened and 

supported by a cooperative agreement 

between FDA and the Duke University, 

Duke-Margolis Institute for Health 

Policy. 

DATES: The public workshop will be 

held on December 12, 2024, from 12:30 

p.m. to 5 p.m., Eastern Time. Either 

electronic or written comments on this 

public workshop must be submitted by 

January 13, 2025. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public workshop will 

be held in-person at the Bethesda North 

Marriott & Conference Center, 5701 

Marinelli Rd., North Bethesda, MD 

20852 and virtually using the Zoom 

platform. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of January 13, 2025. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are received on or before that 

date. 

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– 

2024–N–5057 for ‘‘Optimizing the Use 

of Real-World Evidence in Regulatory 

Decision-Making for Drugs and 

Biological Products—Looking Forward.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: 

Dianne Paraoan, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, 301–796–3161, 

Dianne.Paraoan@fda.hhs.gov or CDERRWE@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The volume and complexity of RWD 

available to support drug development 

have increased substantially over the 

past several decades. This increase, 

combined with enhanced computing 

power and emerging technologies, is 

transforming how drugs are developed. 


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