Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices 3225 

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 

Implementation Plan Guidance for Development and Implementation Grantees ..................................................... 27 1 450 12,150 4,050 

DIG Community Needs and Readiness Assessment .......... 27 1 450 12,150 4,050 

Totals: ........................................................................... ........................ ........................ ........................ 24,300 8,100 

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 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: Title V of the Social 

Security Act, sections 511(e)(8)(A) & 

511(h)(2)(A) 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2025–00556 Filed 1–13–25; 8:45 am] 

BILLING CODE 4184–77–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5890] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Generic Drug User 

Fee Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

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 of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with our generic 

drug user fee program. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

March 17, 2025. 

ADDRESSES: 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 

March 17, 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–5890 for ‘‘Generic Drug User 

Fee Program.’’ 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 


khammond on DSK9W7S144PROD with NOTICES
3226 Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices 

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: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘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 (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Generic Drug User Fee Program 

OMB Control Number 0910–0727— 

Revision 

This information collection helps 

support implementation of FDA’s 

Generic Drug User Fee Program 

(GDUFA), most recently reauthorized 

September 30, 2022. It includes 

information collections discussed in the 

document, ‘‘GDUFA Reauthorization 

Performance Goals And Program 

Enhancements Fiscal Years 2023–2027,’’ 

commonly referred to as the ‘‘Goals 

Letter’’ or ‘‘Commitment Letter.’’ The 

Commitment Letter represents the 

product of FDA discussions with the 

regulated industry and public 

stakeholders, as mandated by Congress. 

The Goals Letter identifies current 

GDUFA program objectives and general 

procedures for communicating with 

FDA. Agency guidance, as outlined in 

the Goals Letter, are utilized in the 

information collection. All Agency 

guidance documents are issued 

consistent with our Good Guidance 

Practice regulations (21 CFR 10.115), 

which provide for public comment at 

any time, as well as regulatory authority 

found in 21 CFR 314.445 (Guidance 

documents), currently approved in OMB 

control number 0910–0001. 

The information collection also 

includes Form FDA 3974, the Generic 

Drug User Fee Cover Sheet and 

associated instructions, available for 

download at https://userfees.fda.gov/ 

OA_HTML/GDUFAFacilityCScreation.

pdf. Form FDA 3974 is used to provide 

a uniform format for the submission of 

information necessary to account for 

and track user fees, and to determine the 

amount of the fee required. 

As we communicate on our website, 

potential applicants are encouraged to 

contact the FDA Generic Drugs Program 

with questions at any point in their 

development and application 

preparation processes. We have revised 

the information collection to include the 

submission of ‘‘controlled 

correspondence’’ within the scope of 

activity, including covered product 

authorizations (CPAs) provided for 

under the Creating and Restoring Equal 

Access to Equivalent Samples Act of 

2019 (CREATES Act) (Pub. L. 116–94). 

Historically, and under the terms of the 

GDUFA, a controlled correspondence 

may be submitted by or on behalf of a 

generic drug manufacturer or related 

industry prior to submitting an 

abbreviated new drug application 

(ANDA). To provide respondents with 

assistance regarding the submission of 

controlled correspondence, we continue 

to develop and issue topic-specific 

Agency guidance, including the 

following documents: 

• Controlled Correspondence Related 

to Generic Drug Development 

(Controlled Correspondence Guidance), 

(https://www.fda.gov/media/164111/ 

download, March 2024) 

• Product-Specific Guidance 

Meetings Between FDA and ANDA 

Applicants Under GDUFA, (https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

product-specific-guidance-meetingsbetween-fda-and-anda-applicantsunder-gdufa, February 2023) 

• Formal Meetings Between FDA and 

ANDA Applicants of Complex Products 

Under GDUFA (https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/formal-meetingsbetween-fda-and-anda-applicantscomplex-products-under-gdufaguidance-industry, October 2022) 

• Competitive Generic Therapies 

Guidance (https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/competitivegeneric-therapies, October 2022) 

• Cover Letter Attachments for 

Controlled Correspondences and ANDA 

Submissions (https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/cover-letterattachments-controlledcorrespondences-and-andasubmissions, June 2023) 

• How to Obtain Covered Product 

Authorization (https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/how-obtaincovered-product-authorization, 

September 2022) 

Each guidance document may be 

downloaded from our website where we 

maintain a searchable database at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. 

FDA estimates the burden of the 

information collection as follows: 


khammond on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices 3227 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Information collection activity Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden 

per 

response 

Total hours 

Submission of Generic Drug User Fee Cover Sheet .......... 500 7.616 3,808 0.5 

(30 minutes) 

1,904 

Submission of Controlled Correspondence as Discussed 

in Agency Topic-Specific Guidance Documents .............. 400 12.5 5000 5 25,000 

Total .............................................................................. ........................ ........................ 8,808 ........................ 26,904 

1 There are no capital costs or operating and maintenance costs associated with this collection of information. 

Our estimated is based on available 

Agency data. Our burden estimate 

reflects an overall increase attributable 

to the inclusion of controlled 

correspondence and new generic drug 

product CPA requests. 

Dated: January 7, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–00564 Filed 1–13–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Physician-Focused Payment Model 

Technical Advisory Committee; 

Meetings 

ACTION: Notice of meetings. 

SUMMARY: This notice announces the 

2025 meetings of the Physician-Focused 

Payment Model Technical Advisory 

Committee (PTAC). These meetings 

include deliberation and voting on 

proposals for physician-focused 

payment models (PFPMs) submitted by 

individuals and stakeholder entities and 

may include discussions on topics 

related to current or previously 

submitted PFPMs. All meetings are 

open to the public. 

DATES: The 2025 PTAC meetings will 

occur on the following dates: 

D Monday–Tuesday, March 3–4, 2025, 

from 9 a.m. to 5 p.m. ET 

D Tuesday–Wednesday, June 3–4, 2025, 

from 9 a.m. to 5 p.m. ET 

D Monday–Tuesday, September 8–9, 

2025, from 9 a.m. to 5 p.m. ET 

D Tuesday–Wednesday, December 9–10, 

2025, from 9 a.m. to 5 p.m. ET 

Please note that times are subject to 

change. If the times change, the ASPE 

PTAC website will be updated (https:// 

aspe.hhs.gov/ptac-physician-focusedpayment-model-technical-advisorycommittee) and registrants will be 

notified directly via email. 

ADDRESSES: All PTAC meetings will be 

held virtually and/or in the Great Hall 

of the Hubert H. Humphrey Building, 

200 Independence Avenue SW, 

Washington, DC, 20201. 

FOR FURTHER INFORMATION CONTACT: Lisa 

Shats, Designated Federal Officer at 

Lisa.Shats@hhs.gov (202) 875–0938. 

SUPPLEMENTARY INFORMATION: 

Agenda and Comments. PTAC will 

hear presentations on proposed PFPMs 

that have been submitted by individuals 

and stakeholder entities and/or 

discussion on topics related to current 

or previously submitted PFPMs. 

Regarding proposed PFPMs, following 

each presentation, PTAC will deliberate 

on the proposed PFPM. If PTAC 

completes its deliberation, PTAC will 

vote on the extent to which the 

proposed PFPM meets criteria 

established by the Secretary of Health 

and Human Services and on an overall 

recommendation to the Secretary (if 

applicable). Time will be allocated for 

public comments. The agenda and other 

documents will be posted on the PTAC 

section of the ASPE website, https://

aspe.hhs.gov/ptac-physician-focusedpayment-model-technical-advisorycommittee, prior to the meeting. The 

agenda is subject to change. If the 

agenda does change, registrants will be 

notified directly via email, the website 

will be updated, and notification will be 

sent out through the PTAC email 

listserv (https://list.nih.gov/cgi-bin/ 

wa.exe?A0=PTAC to subscribe). 

Meeting Attendance. These meetings 

are open to the public and may be 

hosted in-person or virtually. We intend 

that in-person meetings will be held in 

the Great Hall of the Hubert H. 

Humphrey Building. The public may 

attend in person, when feasible, 

virtually, or view the meeting via 

livestream at www.hhs.gov/live. 

Information about how to access the 

meeting virtually or via livestream will 

be sent to registrants prior to the 

meeting; and a telephone number will 

be sent to registrants participating via 

the dial-in only option prior to the 

meeting. Space may be limited, and 

registration is preferred. When 

registration opens, a link to the 

registration page will be available at 

https://aspe.hhs.gov/collaborationscommittees-advisory-groups/ptac/ptacmeetings prior to the meeting. 

Registrants will receive a confirmation 

email shortly after completing the 

registration process. 

Special Accommodations. If sign 

language interpretation or other 

reasonable accommodation for a 

disability is needed, please contact 

PTAC@hhs.gov, no later than two weeks 

prior to the scheduled meeting. 

Authority. 42 U.S.C. 1395(ee); section 

101(e)(1) of the Medicare Access and 

CHIP Reauthorization Act of 2015; 

section 51003(b) of the Bipartisan 

Budget Act of 2018. 

PTAC is governed by provisions of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C app.), which sets 

forth standards for the formation and 

use of federal advisory committees. 

Dated: January 3, 2025. 

Tisamarie B. Sherry, 

Deputy Assistant Secretary for Behavioral 

Health, Disability and Aging Policy, 

Performing the Delegable Duties of the 

Assistant Secretary for Planning and 

Evaluation. 

[FR Doc. 2025–00612 Filed 1–13–25; 8:45 am] 

BILLING CODE 4150–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 


khammond on DSK9W7S144PROD with NOTICES