87376 Federal Register / Vol. 89, No. 212 / Friday, November 1, 2024 / Notices 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

November 15, 2024. 

ADDRESSES: When commenting, please 

reference the applicable form number 

(CMS–10398 #86) and the OMB control 

number (0938–1148). 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: 

CMS–10398 #86/OMB control number: 

0938–1148, 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/ 

medicare/regulations-guidance/ 

legislation/paperwork-reduction-act1995/pra-listing. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at 410–786–4669. 

SUPPLEMENTARY INFORMATION: 

Following is a summary of the use 

and burden associated with the subject 

information collection(s). More detailed 

information can be found in the 

collection’s supporting statement and 

associated materials (see ADDRESSES). 

Generic Information Collection 

1. Title of Information Collection: 

Section 1115 Reentry Demonstration 

Initiative; Type of Information 

Collection Request: New information 

collection request; Use: On April 17, 

2023, CMS released a State Medicaid 

Directors Letter (SMDL #23–003) 

announcing a demonstration 

opportunity to support community 

reentry and improve care transitions for 

individuals who are incarcerated and 

who are otherwise eligible for Medicaid 

to receive medical assistance under title 

XIX. The Section 1115 Reentry 

Demonstration Opportunity (hereinafter, 

‘‘the Reentry Demonstration Initiative’’) 

will allow states to offer coverage for 

certain pre-release services for up to 90 

days prior to the individual’s expected 

release date that could not otherwise be 

covered by Medicaid due to the 

Medicaid inmate exclusion policy. The 

provision is consistent with section 

5032 of the Substance Use Disorder 

Prevention that Promotes Opioid 

Recovery and Treatment for Patients 

and Communities Act (SUPPORT Act) 

(Pub. L. 115–271), ‘‘Promoting State 

Innovations to Ease Transitions 

Integration to the Community for 

Certain Individuals.’’ 

States applying for the Reentry 

Demonstration Initiative must provide a 

minimum set of pre-release services 

called the ‘‘pre-release benefit package.’’ 

The benefit package aims to improve 

transitions for individuals being 

released from jails or prisons and 

returning to their communities. The 

benefit package must include: (1) case 

management to assess and address 

physical and behavioral health needs 

and health-related social needs; and (2) 

medication-assisted treatment services 

for all types of substance use disorders 

as clinically appropriate, with 

accompanying counseling. Also 

required in the minimum set of services 

is a 30-day supply of all prescription 

medications that have been prescribed 

for the beneficiary. 

This collection of information request 

includes three templates that are 

intended to expedite CMS’s review of 

reentry demonstration initiative 

applications and to support state 

implementation planning and related 

transparency by standardizing the 

presentation of key information 

necessary for approvals, thereby 

reducing rounds of clarifying questions 

with state applicants. The three 

templates include the: (1) reentry 

demonstration initiative preprint, (2) 

reentry implementation plan template, 

and (3) reentry budget neutrality 

formulation workbook. The templates 

are strongly encouraged but optional 

and described in the following section. 

Form Number: CMS–10398 #86 (OMB 

control number: 0938–1148); Frequency: 

Annual and on occasion; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

10; Total Annual Responses: 30; Total 

Annual Hours: 300. (For policy 

questions regarding this collection 

contact: Raven Smith at 410–786–3731.) 

William N. Parham III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–25503 Filed 10–31–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3575] 

Reauthorization of the Over-TheCounter Monograph Drug User Fee 

Program; Public Meeting; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is hosting a public meeting to 

discuss proposed recommendations for 

the reauthorization of the Over-TheCounter [OTC] Monograph Drug User 

Fee Program (OMUFA) for fiscal years 

(FYs) 2026 through 2030. Under 

OMUFA, FDA collects user fees to 

support OTC monograph drug activities. 

The current legislative authority for 

OMUFA expires September 30, 2025. At 

that time, new legislation will be 

required to reauthorize OMUFA for 

future fiscal years. Following 

negotiations with the regulated industry 

and consultation with interested 

members of the public, the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) directs FDA to publish 

recommendations for the 

reauthorization of the OMUFA program 

in the Federal Register, provide for a 

period of 30 days for the public to 

provide written comments on such 

recommendations, and hold a meeting 

at which the public may present its 

views on such recommendations. FDA 

will then consider such public views 

and comments and revise such 

recommendations as necessary. 

DATES: The public meeting will be held 

on November 20, 2024, from 9 a.m. to 

12:30 p.m. Submit either electronic or 

written comments on this public 

meeting by December 20, 2024. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public meeting is 

scheduled to be held at the FDA White 

Oak Campus, 10903 New Hampshire 

Ave., Bldg. 31 Conference Center, Rm. 

1503, Silver Spring, MD 20993. 

Entrance for the public meeting 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to https://

www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 212 / Friday, November 1, 2024 / Notices 87377 

ucm241740.htm. Any changes to the 

public meeting location and remote 

information, as appropriate, will be 

posted to https://www.fda.gov/industry/ 

fda-user-fee-programs/over-countermonograph-drug-user-fee-programomufa in advance of the meeting. 

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 December 20, 2024. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is 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– 

2023–N–3575 for ‘‘Reauthorization of 

the Over-the-Counter Monograph Drug 

User Fee Program; Public Meeting; 

Request for Comments.’’ 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. 

• 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, 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. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Taylor, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 4150, 

Silver Spring, MD 20993–0002, 240– 

705–2316, Kimberly.Taylor@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing a public meeting 

to discuss proposed recommendations 

for the reauthorization of OMUFA 

provisions of the FD&C Act, which 

authorize FDA to collect user fees to 

support OTC monograph drug activities. 

The current authorization of the 

program (OMUFA I) expires in 

September 2025. Without new 

legislation, FDA will no longer be able 

to collect user fees for future fiscal years 

to help fund OTC monograph drug 

activities. Section 744N(d) of the FD&C 

Act (21 U.S.C. 379j–73(d)) requires that 

after FDA holds negotiations with 

regulated industry and consults with 

interested members of the public, we do 

the following: (1) present the 

recommendations to the House 

Committee on Energy and Commerce 

and the Senate Committee on Health, 

Education, Labor, and Pensions, (2) 

publish the recommendations in the 

Federal Register, (3) provide a period of 

30 days for the public to provide written 

comments on the recommendations, (4) 

hold a meeting at which the public may 

present its views on the 

recommendations, and (5) after 

consideration of public views and 

comments, revise the recommendations 

as necessary. 

This Federal Register notice, the 30- 

day comment period, and the public 

meeting will satisfy some of these 

requirements. After the public meeting, 

we will revise the recommendations as 

necessary and present our 

recommendations to the Congressional 

committees. 

The purpose of the public meeting 

announced in this Federal Register 

notice is to obtain the public’s views on 

the proposed recommendations for the 

reauthorization of the OMUFA program 

(OMUFA II). The following information 

is provided to help potential meeting 

participants better understand the 

history and evolution of the OMUFA 

program and the current status of the 

proposed OMUFA II recommendations. 

II. What is OMUFA and what does it 

do? 

On March 27, 2020, the Coronavirus 

Aid, Relief, and Economic Security Act 

(or the CARES Act; available at: https:// 

www.congress.gov/116/bills/hr748/ 

BILLS-116hr748enr.pdf) was signed into 

law. The CARES Act included an 

important legislative initiative, detailed 

in amendments to the FD&C Act, that 

reformed and modernized the way 


khammond on DSKJM1Z7X2PROD with NOTICES
87378 Federal Register / Vol. 89, No. 212 / Friday, November 1, 2024 / Notices 

1See https://www.fda.gov/about-fda/center-drugevaluation-and-research-cder/fda-crowdsourcing. 

certain nonprescription, or OTC drugs 

are regulated in the United States. These 

drugs, commonly known as OTC 

monograph drugs, may be marketed 

without an approved drug application 

under section 505 of the FD&C Act (21 

U.S.C. 355) if they meet the 

requirements of section 505G of the 

FD&C Act (21 U.S.C. 355g), as well as 

other applicable requirements. 

Accompanying this OTC monograph 

reform legislation were provisions 

added by the CARES Act to the FD&C 

Act authorizing FDA to assess and 

collect user fees dedicated to OTC 

monograph drug activities. 

This user fee program with respect to 

OTC monograph drugs, which we refer 

to as OMUFA, is modeled after the 

successful Prescription Drug User Fee 

Act (PDUFA). For OMUFA purposes, 

industry-paid fees help support FDA’s 

OTC monograph drug activities, and in 

the OMUFA I commitment letter 

negotiated with industry, FDA agreed to 

adhere to certain performance goals, 

including to review certain submissions 

within specific time frames. Similar to 

PDUFA, FDA anticipates that 

continuing this user fee program will 

provide additional resources to help the 

Agency conduct these important 

regulatory activities in a timely manner 

and ultimately help provide the public 

with access to innovative, safe, and 

effective OTC monograph drugs. 

OMUFA is authorized under sections 

744L and 744M of the FD&C Act (21 

U.S.C. 379j–71 and 379j–72, as added by 

the CARES Act, under which FDA will 

assess and collect fees from submitters 

of OTC Monograph Order Requests 

(OMORs), other than OMORs for certain 

safety changes, as well as from 

qualifying manufacturers of OTC 

monograph drugs, to help support the 

Agency’s OTC monograph drug 

activities. 

OMUFA is intended to provide for 

additional funding so that FDA can hire 

additional staff, improve systems, and 

establish and better manage the 

Agency’s OTC monograph drug 

activities, including making important 

safety-related changes to OTC 

monographs, as needed, and facilitating 

more timely availability of safe, 

effective, high-quality, and innovative 

OTC monograph drugs to the public. As 

part of FDA’s negotiated agreement with 

industry regarding reauthorization, as 

reflected in the accompanying OMUFA 

commitment letter, the Agency agrees to 

certain performance and procedural 

goals and other commitments that apply 

to aspects of the Agency’s OTC 

monograph drug activities. These goals 

apply, for example, to the review of 

OMORs, including safety-related 

OMORs. 

A list of the deliverables to meet 

OMUFA I commitments is available on 

the FDA web page at https://

www.fda.gov/media/146283/download. 

III. Proposed OMUFA II 

Recommendations 

To prepare the proposed 

recommendations to Congress for 

OMUFA reauthorization, FDA 

conducted discussions with the 

regulated industry and consulted with 

interested members of the public, as 

required by the law. We began the 

OMUFA reauthorization process by 

publishing a notice in the Federal 

Register requesting public input on 

reauthorization and announcing a 

public meeting that was held on 

September 28, 2023. The meeting 

included presentations by FDA and a 

series of panels with representatives of 

different interested parties. The 

materials from the meeting, including a 

transcript and webcast recording, can be 

found at https://www.fda.gov/drugs/ 

news-events-human-drugs/publicmeeting-reauthorization-over-countermonograph-drug-user-fee-programomufa-09282023-09282023. 

Following the September 28, 2023, 

public meeting, FDA conducted 

negotiations with the regulated industry 

from November 2023 until June 2024. 

As directed by Congress, FDA posted 

minutes of these meetings on its website 

at https://www.fda.gov/industry/fdauser-fee-programs/omufareauthorization-fiscal-years-2026-2030. 

The proposed recommendations for 

OMUFA II address many of the top 

priorities identified by interested 

members of the public, the regulated 

industry, and FDA. While some of the 

proposed recommendations are new, 

many either build on or refine elements 

from the existing program. Among the 

recommendations are specific proposed 

enhancements in the following areas: (1) 

OMOR review, (2) test methods, (3) 

meeting management, (4) education, (5) 

information transparency, (6) 

monograph product quality 

enhancement, and (7) financial 

transparency and management. The full 

text of the proposed OMUFA II 

commitment letter can be found here at 

https://www.fda.gov/media/182750/ 

download. Each significant new or 

modified enhancement is described 

briefly below: 

A. OMOR Review 

The statute requires that the public 

have the opportunity to comment on 

proposed monograph orders, and thus to 

align with the statute, FDA is proposing 

in the OMUFA II commitment letter that 

no major amendments to an OMOR be 

accepted by the Agency after the public 

comment period for a proposed order 

has closed. This revision helps ensure 

that the public will have the 

opportunity to comment on any changes 

made to the proposed order as a result 

of a major amendment. The statute also 

gives flexibility for the public comment 

period on proposed orders to be 

extended. To acknowledge this 

flexibility and provide greater 

predictability on timing, FDA is 

proposing the final order goal date be 

extended by the same length of any 

public comment period extension, up to 

a certain amount. This is described in 

section I.A.2 of the proposed OMUFA II 

commitment letter. 

The statute also specifies that filing 

eligibility determinations required for 

certain types of OMORs occur after 

submission of the OMOR to the Agency. 

In recognition that this activity takes 

time, FDA is proposing to extend the 

filing assessment period for these 

OMORs. This is described in section 

I.C.2 of the OMUFA II commitment 

letter. Additionally, to provide more 

clarity on the filing eligibility portion of 

the filing assessment process, FDA is 

proposing to draft guidance pertaining 

to the eligibility determination 

requirements and implementation. This 

enhancement is described in section I.I 

of the OMUFA II commitment letter. 

B. Test Methods 

Some of the test methods in OTC 

monographs were established decades 

ago and may not reflect the latest 

scientific methodology. To solicit 

general feedback from interested 

members of the public on issues of 

concern with test methods in existing 

monographs (final orders), FDA is 

proposing to issue a Federal Register 

notice followed by a crowdsourcing on 

FDA’s crowdsourcing platform 1 to 

further refine the public input. This 

enhancement is described in section 

I.H.2 of the OMUFA II commitment 

letter. 

Additionally, FDA is proposing that 

Congress amend the statute to add a 

new type of Tier Two OMOR for 

OMORs proposing the addition or 

modification of certain testing methods 

in OTC monographs. To qualify for this 

new type of Tier Two OMOR, these 

additional or modified testing methods 

would need to be reflected in a 

voluntary consensus standard for 

pharmaceutical quality established by a 

national or international standards 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 212 / Friday, November 1, 2024 / Notices 87379 

2See FDA’s guidance on ‘‘CDER’s Program for the 

Recognition of Voluntary Consensus Standards 

Related to Pharmaceutical Quality Guidance for 

Industry,’’ available at https://www.fda.gov/media/ 

121305/download. 

3See https://www.fda.gov/about-fda/center-drugevaluation-and-research-cder/fda-crowdsourcing. 

development organization and would 

also need to be recognized by FDA (via 

a process described in guidance 2) prior 

to submission of the OMOR, with such 

recognition being made available on the 

FDA website. See also section I.B.1 of 

the OMUFA II commitment letter. 

C. Meeting Management 

To enhance overall meeting 

management, FDA is proposing a new 

mechanism to allow requestors to 

submit clarifying questions to the 

Agency within a certain time period 

following receipt of meeting minutes or 

a written response, in lieu of submitting 

a new meeting request. FDA is also 

proposing to expand the Type Y 

meeting to include requests for feedback 

on a protocol synopsis and to allow 

protocol synopsis feedback as a standalone topic at a Type Z meeting. 

Furthermore, FDA is proposing that for 

OMUFA performance goals to be 

applied to a meeting request, it must be 

submitted through the CDER NextGen 

portal (or any successor system). These 

enhancements are described in section 

I.E.1 of the proposed OMUFA II 

commitment letter. 

Additionally, FDA recognizes that 

many OTC-related Advisory Committee 

(AdCom) meetings pertain to multiple 

OTC drug products and classes, rather 

than to products of a single requestor. 

The Agency also understands that 

impacted parties may need appropriate 

time to coordinate and prepare for the 

AdCom meeting. FDA is proposing that 

for this subset of OTC monographrelated AdCom meetings (where the 

existing policy on advance notice in 

FDA’s 2008 Advisory Committee 

Meetings Guidance does not apply) that 

are not related to an emerging safety 

issue, FDA intends to announce the 

meeting on its website at least 100 

business days in advance of the 

meeting. This enhancement is described 

in section I.E.10 of the OMUFA 

commitment letter. 

D. Education 

External parties often have questions 

regarding processes and procedures 

related to OTC-monograph related data. 

To better understand what questions 

industry and other parties have about 

the process FDA intends to use for 

obtaining data to be used in FDAinitiated generally recognized as safe 

(GRASE) finalizations and how industry 

might organize and submit data for both 

FDA-initiated and industry-initiated 

(GRASE) finalizations, FDA is proposing 

to run a crowdsourcing on FDA’s 

crowdsourcing platform 3 to solicit 

questions about the process from 

interested members of the public, 

followed by a webinar to answer those 

questions for which established policy 

exists. This enhancement is described in 

section I.H.I of the proposed OMUFA II 

commitment letter. 

FDA is also proposing hosting a 

webinar to detail steps about how to 

submit an OMOR using the NextGen 

Portal. This enhancement is described 

in section II.D of the OMUFA II 

commitment letter. Furthermore, FDA is 

proposing to issue draft guidance to 

provide additional information on 

confidentiality of information submitted 

to FDA in connection with proceedings 

under section 505G of the FD&C Act, 

including with respect to an OMOR. 

This enhancement is described in 

section I.1.2 of the OMUFA II 

commitment letter. 

Furthermore, FDA is proposing to 

work to finalize the proposed order/ 

draft guidance pair relating to minor 

changes in dosage form for solid oral 

OTC monograph drug products, which 

FDA committed to develop under the 

terms of the OMUFA I commitment 

letter. This enhancement is described in 

section I.J of the OMUFA II commitment 

letter. 

E. Information Transparency 

To ensure that historical information 

related to OTC monograph drug 

products is accessible to the public, 

FDA is proposing to post to a public 

docket the pre-OMUFA documents that 

were catalogued as part of OMUFA I. 

Additionally, FDA is proposing to 

maintain the historical status of the OTC 

Rulemaking website. 

To help increase transparency around 

marketing exclusivity in the context of 

OTC monograph drugs, FDA is 

proposing to publish a web page 

detailing information regarding 

monograph-related exclusivity afforded 

by final orders. These enhancements are 

described in section II of the proposed 

OMUFA II commitment letter. 

F. Monograph Product Quality 

Enhancement 

To enhance monograph product 

quality surveillance, FDA is proposing 

several initiatives to help focus its 

efforts in this area, including vetting a 

certain percentage of new OTC 

monograph drug registrants within a 

certain number of months of registration 

to confirm whether they should be 

included in CDER’s catalog of OTC 

monograph drugs and establishments. It 

is also proposing to update the riskbased Site Selection Model it uses to 

prioritize drug-related surveillance 

inspections and its associated manual of 

policy and procedure to include risk 

factors associated with OTC monograph 

drugs, as appropriate. FDA is also 

proposing to hold a workshop to assist 

industry in improving quality and 

compliance with current good 

manufacturing practice requirements. 

To increase transparency around its 

surveillance efforts in general, FDA is 

proposing to report aggregate 

information about records requests 

issued to OTC monograph drug 

manufacturers on its website and 

enhance its warning letters web page. 

These enhancements are described in 

section III of the proposed OMUFA II 

commitment letter. 

G. Financial Transparency 

To promote transparency and help 

focus user fee recovery efforts, FDA is 

proposing several mechanisms to 

highlight and enhance information 

about facilities in arrears. Proposed 

mechanisms include taking steps to 

increase the visibility of the arrears list, 

enhancing the list to include whether a 

firm is foreign or domestic and 

publishing on a quarterly basis a list of 

all facilities that have paid the OMUFA 

facility fee for the prior fiscal year. FDA 

is also proposing to publish summary 

registration and arrears information in 

the annual OMUFA financial reports 

and to use information from records 

requests issued to OTC monograph drug 

manufacturers to focus outstanding user 

fee recovery efforts. This enhancement 

is described in section IV of the 

proposed OMUFA II commitment letter. 

H. Financial Management 

The current overall OMUFA fee 

structure and the fee setting process 

were established by Congress for 

OMUFA I. There are two fee types: 

facility fees and OMOR fees. The 

process and adjustments for establishing 

annual target revenue for facility fees 

are defined in statute; the OMOR fee 

amounts were set in statute for the first 

year of OMUFA I and are adjusted for 

inflation each year thereafter. FDA is 

proposing that Congress amend the 

statute to make several targeted 

modifications to the process to enhance 

administrative efficiency and to ensure 

that FDA has adequate and timely user 

fee funding. Currently, the annual 

OMUFA facility fee due date is in June 

of the fiscal year, and thus not aligned 

with the October 1 due date for annual 

fees under other drug user fee programs. 


khammond on DSKJM1Z7X2PROD with NOTICES
87380 Federal Register / Vol. 89, No. 212 / Friday, November 1, 2024 / Notices 

This leads to administrative burdens 

and financial inefficiencies for the 

Agency and can be confusing for 

manufacturers that participate in other 

user fee programs. To address this issue, 

FDA is proposing that Congress shift the 

facility fee due date to October and 

change the liability period for annual 

facility fees to be the 12 months 

immediately preceding the start of the 

fiscal year for which the fees are due. 

The proposal also includes an option for 

the facility to be paid in two 

installments in the transition year to 

ease the burden on fee-paying 

companies. 

To ensure that FDA is adequately 

resourced with OMUFA fees, FDA is 

also proposing that Congress authorize a 

one-time adjustment in calculating 

annual target revenue if the average 

number of fee-liable facilities exceeds a 

particular number in certain years of 

OMUFA II. This would help 

accommodate the additional work 

required to oversee these facilities. If 

this adjustment is made, FDA is 

proposing it would be part of the base 

revenue going forward. Additionally, 

FDA is proposing that Congress reset the 

starting base revenue for OMUFA II to 

include the additional direct cost 

adjustment from the final year of 

OMUFA I, which reflects funding to 

support information technology 

operations and maintenance activities. 

H. Impact of OMUFA II Enhancements 

on User Fee Revenue 

To implement the proposed 

enhancements for OMUFA II, user fee 

funding for a cumulative total of 11 fulltime equivalent staff is proposed to be 

phased in by Congress over the course 

of OMUFA II. The proposed new 

funding will be phased in as follows, as 

an additional dollar amount in annual 

fee setting: 

• $2,373,000 for FY 2026. 

• $1,233,000 for FY 2027. 

• $854,000 for FY 2028. 

In addition, to support the other 

additional direct costs associated with 

the OMUFA II enhancements, the 

following amounts are proposed to be 

added as an additional direct cost 

adjustment: 

• $135,000 for FY 2026. 

• $300,000 for FY 2027. 

• $55,000 for FY 2028. 

• $30,000 for FY 2030. 

IV. Public Meeting Information 

A. Purpose and Scope of the Meeting 

The public meeting will include a 

presentation by FDA and a series of 

invited panels representing different 

interested parties. For members of the 

public who would like to make verbal 

comments on the proposed 

enhancements and other 

recommendations (see instructions 

below), there will be a public comment 

period at the end of the meeting. 

Individuals can also submit written 

comments to the docket [LINK] before 

and after the meeting until December 

20, 2024. 

B. Participating in the Public Meeting 

Registration: Persons interested in 

attending this public meeting must 

register online by 11:59 p.m. Eastern 

Time on November 19, 2024, at https:// 

fda.zoomgov.com/webinar/register/WN_

aW5YWtFfQiyOSzkABY3G4A#/ 

registration. Provide complete contact 

information for each attendee, including 

name, title, affiliation, address, email, 

and telephone. 

Opportunity for Public Comment: 

Those who register online by November 

13, 2024, will have the opportunity to 

participate in the public comment 

session of the meeting. If you wish to 

speak during the public comment 

session, respond ‘‘yes’’ to that question 

in the registration form. We will do our 

best to accommodate requests to make 

public comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

comments and request time jointly. All 

those who wish to make a public 

comment during the meeting must be 

registered by November 13, 2024, at 

11:59 p.m. Eastern Time. We will 

determine the amount of time allotted to 

each commenter, the approximate time 

each comment is to begin, and will 

select and notify participants by 

November 18, 2024. No commercial or 

promotional material will be permitted 

to be presented at the public meeting. 

Streaming Webcast of the Public 

Meeting: This public meeting will also 

be webcast. You will be asked to 

indicate in your registration if you plan 

to attend in person or via the webcast. 

The webcast for this public meeting is 

available at https://fda.zoomgov.com/ 

webinar/register/WN_

aW5YWtFfQiyOSzkABY3G4A#/ 

registration. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). A link to the 

transcript will also be available on the 

internet at https://www.fda.gov/drugs/ 

news-events-human-drugs/publicmeeting-recommendations-overcounter-monograph-drug-user-feeprogram-omufa-reauthorization. 

Dated: October 28, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–25458 Filed 10–31–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Data System 

for Organ Procurement and 

Transplantation Network 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than December 31, 

2024. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14NWH04, 5600 Fishers 

Lane, Rockville, Maryland, 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Data System for Organ Procurement and 

Transplantation Network, OMB No. 

0915–0157—Revision. 

Abstract: Section 372 of the Public 

Health Service Act requires that the 

Secretary of Health and Human 

Services, by awards, provide for the 

establishment and operation of the 

Organ Procurement and Transplantation 

Network (OPTN), which, under HRSA’s 


khammond on DSKJM1Z7X2PROD with NOTICES