Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Notices 14507 

receipt of the IND that the 

investigational studies were allowed to 

proceed. 

2. The date the application was 

initially submitted with respect to the 

human biological product under section 

351 of the Public Health Service Act (42 

U.S.C. 262): November 24, 2020. FDA 

has verified the applicant’s claim that 

the biologics license application (BLA) 

for Rybrevant (BLA B761210) was 

initially submitted on November 24, 

2020. 

3. The date the application was 

approved: May 21, 2021. FDA has 

verified the applicant’s claim that BLA 

B761210 was approved on May 21, 

2021. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 546 days of patent 

term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: February 22, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–03961 Filed 2–26–24; 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: Ryan White 

HIV/AIDS Program Core Medical 

Services Waiver Form, OMB No. 0906– 

0065—Revision 

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 April 29, 2024. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N39, 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: 

Ryan White HIV/AIDS Program Core 

Medical Services Waiver Form, OMB 

No. 0915–0065—Revision 

Abstract: In accordance with sections 

2604(c), 2612(b), and 2651(c) of the 

Public Health Service Act, recipients are 

required to spend not less than 75 

percent of funds on core medical 

services for individuals with HIV 

identified and eligible under the statute, 

after reserving permissible amounts for 

administrative and clinical quality 

management (CQM) costs. The statute 

also grants the Secretary of Health and 

Human Services authority to waive this 

requirement for a Ryan White HIV/AIDS 

Program (RWHAP) Part A, B, or C 

recipient if certain requirements are 

met, and a waiver request is submitted 

to HRSA for approval. 

As currently implemented by HRSA, 

to be approved, (1) core medical 

services must be available and 

accessible to all individuals identified 

and eligible for the RWHAP in the 

recipient’s service area within 30 days. 

This access must be without regard to 

payer source, and without the need to 

spend at least 75 percent of funds 

remaining from the recipient’s RWHAP 

award after statutorily permissible 

amounts for administrative and CQM 

costs are reserved; (2) the recipient must 

ensure there are no AIDS Drug 

Assistance Program (ADAP) waiting 

lists in their service area; and (3) a 

public process to obtain input on the 

waiver request must have occurred. This 

process must seek input from impacted 

communities including clients and 

RWHAP-funded core medical services 

providers on the availability of core 

medical services, and the decision to 

request the waiver. The public process 

may be a part of the same one used by 

recipients to seek input on community 

needs as part of the annual priority 

setting and resource allocation, 

comprehensive planning, statewide 

coordinated statement of need, public 

planning, and/or needs assessment 

processes. RWHAP Parts A, B, and C 

core medical services waiver requests 

must include funds awarded under the 

Minority AIDS Initiative. Core medical 

services waivers are effective for a 1- 

year period. 

The process for RWHAP Parts A, B, 

and C grant recipients to request a 

waiver of the minimum expenditure 

amount requirements for core medical 

services is outlined in Policy Notice 21– 

01, Waiver of the Ryan White HIV/AIDS 

Program Core Medical Services 

Expenditure Requirement. 

HRSA proposes to modify the onepage form to include the proposed 

percentages of HIV service dollars 

allocated to core medical and support 

services. Under the proposed changes, a 

field will be added to the form to 

capture the proposed percentages. This 

information will inform HRSA whether 

recipients are able to meet the statutory 

requirements in sections 2604(c), 

2612(b), and 2651(c) of the Public 

Health Service Act and will clarify what 

proposed portion of funds will be 

allocated to core medical and support 

services. Minor changes will also be 

made to the form to increase readability. 

Summary of Proposed Changes: 

Sections 2604(c), 2612(b), and 2651(c) of 

the Public Health Service Act requires 

recipients to spend not less than 75 

percent of funds on core medical 

services after reserving statutorily 


lotter on DSK11XQN23PROD with NOTICES1
14508 Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Notices 

1Sections 2604(c)(2), 2612(b)(2), and 2651(c)(2) of 

the PHS Act. 

permissible amounts for administrative 

and CQM costs. However, on the prior 

version of the form, the portion of HIV 

service dollars to be allocated to core 

medical and support services was 

sometimes unclear. The suggested 

change adds a requirement to include 

the proposed percentages of HIV service 

dollars allocated to core medical and 

support services on the form. The table 

on the prior form is expanded to allow 

for the insertion of the proposed 

percentages for core medical and 

support services. Instructions at the top 

of the new form are updated to indicate 

where to insert the proposed 

percentages. Language within the table 

is also updated to increase readability. 

The proposed changes do not modify 

the underlying requirements necessary 

to obtain a waiver: all core medical 

services are available and accessible 

within 30 days in the jurisdiction or 

service area; ensuring that the state 

ADAP has no waiting lists; and that the 

recipient has used a public process to 

determine the need for a waiver. 

Recipients may still need to provide 

supportive evidence to HRSA upon 

request. 

Need and Proposed Use of the 

Information: HRSA uses the 

documentation submitted in core 

medical services waiver requests to 

determine if the RWHAP Parts A, B, and 

C grant applicant or recipient meets the 

statutory requirements for waiver 

eligibility including: (1) no waiting lists 

for ADAP services; and (2) evidence of 

core medical services availability within 

the grant recipient’s jurisdiction, state, 

or service area to all persons with HIV 

identified and eligible under Title XXVI 

of the Public Health Service Act.1

Likely Respondents: HRSA expects 

responses from RWHAP Parts A, B, and 

C grant applicants and recipients. The 

number of grant recipients requesting 

waivers has fluctuated annually and 

ranged up to 23 per year since its 

implementation in fiscal year 2007. In 

light of recent trends, HRSA anticipates 

receiving possibly up to 23 applications 

in a given year. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

Total Estimated Annualized Burden 

Hours: 

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total 

burden 

hours 

RWHAP ........................................................................................

Core Medical Services Waiver Request Attestation Form .......... 23 1 23 0.49 11.27 

Total ...................................................................................... 23 1 23 0.49 11.27 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2024–03952 Filed 2–26–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Risk, Prevention and 

Health Behavior Integrated Review Group; 

HIV/AIDS Intra- and Inter-personal 

Determinants and Behavioral Interventions 

Study Section. 

Date: March 20–21, 2024. 

Time: 8:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: St. Gregory Hotel, 2033 M Street 

NW, Washington, DC 20036. 

Contact Person: Mark P Rubert, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5218, 

MSC 7852, Bethesda, MD 20892, 301–806– 

6596, rubertm@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Aging and Development, Auditory 

Vision and Low Vision Technologies. 

Date: March 20–21, 2024. 

Time: 9:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Canopy by Hilton, 940 Rose Avenue, 

North Bethesda, MD 20852. 

Contact Person: Barbara Susanne Mallon, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, (301) 480–8992, mallonb@

mail.nih.gov. 


lotter on DSK11XQN23PROD with NOTICES1