Federal Register / Vol. 89, No. 29 / Monday, February 12, 2024 / Notices 9857 

1The GDUFA III commitment letter is available 

at https://www.fda.gov/media/153631/download. 

Performance Goals and Program 

Enhancements Fiscal Years 2023–2027 

(GDUFA III commitment letter),1 FDA 

agreed to conduct annual public 

workshops ‘‘to solicit input from 

industry and stakeholders for inclusion 

in an annual list of GDUFA III 

regulatory science initiatives.’’ This 

public workshop scheduled for May 20 

and 21, 2024, seeks to fulfill this 

agreement. 

II. Topics for Discussion at the Public

Workshop

The purpose of this public workshop 

is to obtain input from industry and 

other interested stakeholders on 

identifying generic drug science and 

research initiatives for FY 2025. FDA is 

interested in receiving input about 

regulatory science initiatives for the 

ongoing years of the GDUFA III science 

and research program, and particularly 

for FY 2025. 

Topics discussed during the 

workshop will focus on research that is 

needed to address scientific knowledge 

gaps and associated challenges 

impacting the development and 

regulatory assessment of generic 

products, including complex generics. 

As examples, topics discussed will 

likely relate to nitrosamine drug 

substance-related impurities, drugdevice combination products, predictive 

tools to improve the efficiency of 

generic product development, and other 

topics that can enhance public access to 

high quality, safe and effective generic 

products. Specific presentations and 

discussions at this workshop will be 

announced at a later date and may differ 

from the topics above. Input about the 

topics above will help the Agency 

identify and expand its scientific focus 

for the next fiscal year. 

FDA will consider all comments made 

at this workshop or received through the 

docket (see ADDRESSES) as it develops its 

FY 2025 science and research 

initiatives. Information concerning the 

science and research initiatives for 

generic drugs can be found on the 

Science & Research website at https://

www.fda.gov/drugs/generic-drugs/ 

science-research. 

III. Participating in the Public

Workshop

Registration: Registration is free. 

Persons interested in attending this 

public workshop must register online at 

https://fda.zoomgov.com/webinar/ 

register/WN_qwJcEJcWQeeglLe

ZMD2MCg. Registration may be 

performed at any time before or during 

the workshop. 

If you need special accommodations 

due to a disability, please contact FDA 

via email at GDUFARegulatoryScience@

fda.hhs.gov no later than 11:59 p.m. 

eastern time on May 10, 2024. 

Requests for Oral Presentations: 

During online registration you may 

indicate if you wish to present your 

public comments. Requests to provide 

public comments via a pre-recorded 

presentation or a live presentation, 

including in-person or virtual 

presentations, should be submitted via 

email to GDUFARegulatoryScience@

fda.hhs.gov by 11:59 p.m. Eastern Time 

on March 8, 2024. 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 

presentations, and request time for a 

joint presentation, or submit requests for 

designated representatives to participate 

in the workshop. Based upon the public 

comment presentation requests received 

by March 8, 2024, at 11:59 p.m. eastern 

time, we will determine the amount of 

time allotted to each presenter and the 

approximate time each oral presentation 

is to begin; we will select and notify 

participants by April 1, 2024. If selected 

for presentation, any presentation 

materials must be emailed to GDUFA

RegulatoryScience@fda.hhs.gov no later 

than May 10, 2024, 11:59 p.m. eastern 

time. No commercial or promotional 

material will be permitted to be 

presented or distributed at the public 

workshop. 

Streaming Webcast of the Public 

Workshop: This public workshop will 

be webcast. Please register online (as 

described above) to attend the workshop 

remotely (virtually). Registrants will 

receive a hyperlink that provides access 

to the webcast on both days. Although 

FDA verified the website addresses in 

this document, please note that websites 

are subject to change over time. 

Transcripts: Please be advised that as 

soon as a video recording and audio 

transcript of the public workshop are 

available, they will be accessible at 

https://www.regulations.gov or via the 

Science & Research FDA website 

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

generic-drugs/science-research. They 

may also be available for viewing at the 

Dockets Management Staff (see 

ADDRESSES). 

Dated: February 6, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–02841 Filed 2–9–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0945–0005] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before April 12, 2024. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov, PRA@hhs.gov, 

or by calling (202) 264–0041. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0945–0005 and 

project title for reference, to Sherrette A. 

Funn, email: Sherrette.Funn@hhs.gov, 

PRA@hhs.gov, or call (202) 264–0041 

the Reports Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (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.

Title of the Collection: HIPAA Audit 

Review Survey. 

Type of Collection: Reinstatement, 

with Change, of a Previously Approved 

Collection OMB No. 0945–0005: Office 

for Civil Rights (OCR)—Health 

Information Privacy Division. 

Abstract: This information collection 

consists of 39 online survey questions 

that will be sent to 207 covered entities 

and business associates that participated 

in the 2016–2017 OCR HIPAA Audits. 

The survey will gather information 

relating to the effect of the audits on the 

audited entities and the entities’ 

opinions about the audit process. 

OCR is conducting a review of the 

2016–2017 HIPAA Audits to determine 

its efficacy in assessing the HIPAA 

compliance efforts of covered entities. 


khammond on DSKJM1Z7X2PROD with NOTICES
9858 Federal Register / Vol. 89, No. 29 / Monday, February 12, 2024 / Notices 

As part of that review, the online survey 

will be used to: 

Measure the effect of the 2016–2017 

HIPAA Audits on covered entities’ and 

business associates’ subsequent actions 

to comply with the HIPAA Rules. 

Provide entities with an opportunity 

to give feedback on the Audit and its 

features, such as the helpfulness of 

HHS’ guidance materials and 

communications, the utility of the 

online submission portal, whether the 

Audit helped improve entity 

compliance, and the entities’ responses 

to the Audit-report findings and 

recommendations. 

Provide OCR with information on the 

burden imposed on entities to collect 

audit-related documents and to respond 

to audit-related requests; and 

Seek feedback on the effect of the 

HIPAA Audit program on the entities’ 

day-to-day business operations. 

The information, opinions, and 

comments collected using the online 

survey will be used to improve future 

OCR HIPAA Audits. 

ANNUALIZED BURDEN HOUR TABLE

Form name Respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

Total 

burden 

hours 

OCR HIPAA Audit Participant Survey.Covered Entity Privacy and Security 

Officer(s) or Administrators.

166 1 45/60 124.5 

OCR HIPAA Audit Participant Survey.Business Associate Privacy and Security Officer(s) or Administrators.41 1 45/60 30.75 

Total ........................................... ........................................................... 207 ........................ ........................ 155.25 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2024–02737 Filed 2–9–24; 8:45 am] 

BILLING CODE 4153–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Maximizing 

Investigators’ Research Award—E Study 

Section, March 05, 2024, 8 a.m. to 

March 6, 2024, 6 p.m., Center for 

Scientific Review, RKL2, 6701 

Rockledge Dr, Bethesda, MD, 20817 

which was published in the Federal 

Register on February 06, 2024, 89 FR 

8218, Doc 2024–02265. 

This meeting is being amended to 

change the meeting start time from 8 

a.m. to 9 a.m. The meeting is closed to 

the public. 

Dated: February 6, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–02775 Filed 2–9–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 

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: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Investigator Initiated 

Extended Clinical Trial (R01 Clinical Trial 

Required). 

Date: March 8, 2024. 

Time: 12:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Rockville, MD 

20892 (Video Assisted Meeting). 

Contact Person: Lindsey M. Pujanandez, 

Ph.D., Scientific Review Officer, Immunology 

Review Branch, Scientific Review Program, 

Division of Extramural Activities, National 

Institute of Allergy and Infectious Diseases, 

National Institutes of Health, 5601 Fishers 

Lane, MSC 9834, Rockville, MD 20852, (240) 

627–3206, lindsey.pujanandez@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: February 6, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–02773 Filed 2–9–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; 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 

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: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel; URGenT: Translational 

Efforts to Advance Gene-based Therapies for 

Ultra-Rare Neurological and Neuromuscular 

Disorders. 

Date: February 27, 2024. 

Time: 10:00 a.m. to 1:00 p.m. 


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