90708 Federal Register / Vol. 89, No. 222 / Monday, November 18, 2024 / Notices 

requesting a waiver must submit 

documentation to FDA, including the 

number of their employees, as well as 

information that their application is 

their first human drug application, 

within the meaning of the FD&C Act, to 

be submitted to the Agency for 

approval. 

We estimate receiving 22 requests for 

reconsideration annually (including 

small business waiver reconsiderations) 

and assume the average burden for 

preparing and submitting each request 

is 24 hours. In addition, we estimate 

receiving six requests annually for 

appeal of user fee waiver 

determinations, and assume the time 

needed to prepare an appeal is 12 hours. 

We have included in this estimate both 

the time needed to prepare the request 

for appeal to the Chief Scientist and 

User Fee Appeals Officer within the 

Office of the Commissioner, and the 

time needed to create and send a copy 

of the request for an appeal to the 

Director Division of User Fee 

Management within the Office of 

Management at FDA’s Center for Drug 

Evaluation and Research. 

We assume a total of 82 hours of 

burden for completing and submitting 

the 164 forms FDA 3397 (Prescription 

Drug User Fee Coversheet) along with 

submission of NDAs or BLAs. The 

burdens associated with submission of 

NDAs and BLAs are included in OMB 

control numbers 0910–0001 and 0910– 

0338, respectively. 

The information collection reflects 

changes and adjustments. We have 

clarified that the scope of the collection 

includes provisions found in our 

current commitment goals letter, 

negotiated with industry, pertaining to 

the assessment of fees, waivers, refunds, 

and exemptions under PDUFA VII. 

Cumulatively these changes and 

adjustments have resulted in an increase 

of three responses and 203 burden hours 

annually since the prior renewal of the 

information collection. We attribute this 

to the steady state of incoming requests 

for waivers and reconsiderations and 

normal fluctuations in types of 

submissions or waivers received. 

Dated: October 30, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–26801 Filed 11–15–24; 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: Generic 

Information Collection Request for 

Health Resources and Services 

Administration Hotlines, Chatlines, and 

Online Portals 

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 January 17, 2025. 

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: 

Generic Information Collection Request 

for Collections Related to HRSA 

Hotlines, Chatlines, and Online Portals, 

OMB No. 0906–New. 

Abstract: HRSA currently administers 

approximately 15 hotlines, chatlines, 

and online portals for use by customers, 

members of the public, and HRSA 

funding recipients. These hotlines, 

chatlines, and online portals are 

administered by HRSA or a contractor 

on behalf of HRSA. The purpose of 

information collections under this 

generic umbrella ICR package is to allow 

HRSA to collect information on the 

operation of such HRSA hotlines, 

chatlines, and online portals to assist 

HRSA in improving their operation and 

determining if these services are 

helpful. In addition to collecting basic 

demographic information, the 

information collections would include 

questions such as reasons for inquiry, 

topics covered by inquiry, feedback on 

provided guidance or the hotline/ 

chatline/online portal user experience. 

No protected information, such as 

personal health information or trade 

secrets, will be disclosed unless 

specifically required by law. 

An illustrative, but not exhaustive, 

list of examples of information 

collection activities that would fall 

under this collection include 

standardized questions that are asked 

during the interaction with the public; 

surveys about their interaction; and 

information collected about their 

experience in use of hotlines, chatlines, 

and online portals. This generic 

umbrella ICR covers responses to 

standardized and survey questions 

relating to public use of HRSA’s 

hotlines, chatlines, and online portals, 

pursuant to the ‘‘Social Media, WebBased Interactive Technologies, and the 

Paperwork Reduction Act’’ 2010 White 

House guidance memo. The memo can 

be found at: https://

www.whitehouse.gov/wp-content/ 

uploads/legacy_drupal_files/omb/ 

assets/inforeg/SocialMediaGuidance_

04072010.pdf. 

Need and Proposed Use of the 

Information: The purpose of collections 

under this generic umbrella ICR is for 

accountability, program management, 

and oversight purposes. Collecting 

feedback from members of the public 

about their interaction with these 

services will help ensure that HRSA 

hotlines, chatlines, and online portals 

are operating to the best of their 

abilities. While HRSA can evaluate the 

general need for and the overall 

practical utility of such information 

collection in advance, HRSA is unable 

to determine the details of the specific 

individual collection methodologies 

until a later time. Using a generic 

umbrella ICR will allow HRSA to 

quickly and nimbly respond to public 

needs and efficiently provide vital 

services to grantees and the general 

public, as the standard 6 to 9 month 

timeline to comply with a full request 

under the Paperwork Reduction Act 

could inhibit HRSA’s ability to collect 

information to inform these activities 

that involve rapid updates to be 

responsive to their users. The 

information collected is expected to be 

voluntary and low-burden. Therefore, a 

generic umbrella ICR clearance is 

requested to allow for quick turnaround 


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Federal Register / Vol. 89, No. 222 / Monday, November 18, 2024 / Notices 90709 

requests for similar information 

collections related to these activities. 

As this generic umbrella ICR will 

focus on the awareness, understanding, 

attitudes, preferences, or experiences of 

customers or other stakeholders relating 

to HRSA-funded hotlines, chatlines, or 

portals, the Fast Track Process should 

apply to this information collection. 

Therefore, HRSA also requests OMB 

provide a response on individual 

information collection requests within 

the scope of this generic ICR within 5 

business days. 

Likely Respondents: The most likely 

respondents include users of a HRSAfunded hotline, chatline, or portal. 

These users may include members of 

the public and public or private entities 

who receive HRSA funding. Responses 

to any information collections under 

this generic umbrella ICR are not 

required to obtain or retain any benefit. 

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. HRSA conducted 

this estimate based on reviewing hotline 

and chatline scripts along with online 

portals, in addition to reviewing the 

burden estimates of forms from previous 

HRSA customer service surveys, which 

were approved under other umbrella or 

regular packages. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Instrument name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Standardized Hotline Interaction .......................................... 100,000 1 100,000 0.17 17,000.00 

Standardized Chatline Interaction ........................................ 100,000 1 100,000 0.17 17,000.00 

Online Portal Submission .................................................... 10,000 1 10,000 0.067 670.00 

Follow-Up Surveys ............................................................... 51,750 1 51,750 0.083 4,295.25 

Total .............................................................................. 261,750 ........................ 261,750 ........................ 38,965.25 

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. 2024–26742 Filed 11–15–24; 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: Center for Scientific 

Review Special Emphasis Panel; PAR–23– 

137: Science Education Partnership Award 

(SEPA) R25. 

Date: December 11–12, 2024. 

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

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: James J Li, Ph.D., Scientific 

Review Officer, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Room 5148, MSC 7849, Bethesda, MD 

20892, 301–806–8065, lijames@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Drug Discovery for Aging, 

Neurodegenerative and Neurological 

Disorders—Panel B. 

Date: December 11, 2024. 

Time: 9:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health 

Rockledge II, 6701 Rockledge Drive Bethesda, 

MD 20892 (Virtual Meeting). 

Contact Person: Kathryn Partlow, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 1016D, 

Bethesda, MD 20892 (301) 594–2138 

partlowkc@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Specialized 

Centers of Research Excellence (SCORE) on 

Sex Differences. 

Date: December 11–12, 2024. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892, (Virtual Meeting). 

Contact Person: Elaine Sierra-Rivera, Ph.D. 

IRG Chief Center for Scientific Review 

National Institutes of Health 6701 Rockledge 

Drive, Room 6182 Bethesda, MD 20892 (301) 

435–2514 riverase@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business-Anti-Infective Therapeutics. 

Date: December 11–12, 2024. 

Time: 10:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892, (Virtual Meeting). 

Contact Person: Marcus Ferrone, PHARMD 

Scientific Review Officer Center for Scientific 

Review National Institutes of Health 6701 

Rockledge Drive Bethesda, MD 20892 (301) 

402–2371 marcus.ferrone@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Molecular Oncology. 

Date: December 11, 2024. 

Time: 11:00 a.m. to 6:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 


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