Federal Register / Vol. 87, No. 61 / Wednesday, March 30, 2022 / Notices 18373 

time required for this task may range 

from 5 to 15 minutes; we used the 

median, 10 minutes, for the average 

burden per disclosure (see table 1). 

TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN1 

21 CFR section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 2

54.4(b)—Clinical Investigators ............................................. 13,082 1 13,082 0.17 2,224 

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

2 Numbers have been rounded. 

The burden for this information 

collection request has changed since the 

last OMB approval. Our estimated 

burden for the information collection 

reflects a 298 hour increase. We have 

adjusted our estimated burden for the 

information collection to reflect the 

number of submissions we received in 

the last few years. Additionally, for 

products regulated by the Center for 

Devices and Radiological Health, we 

now include De Novo requests as a type 

of application that may rely on clinical 

studies. Upon review, we have corrected 

an inadvertent omission regarding the 

number of BLAs and BLA efficacy 

supplements received by our Center for 

Drug Evaluation and Research and used, 

in part, as a basis for calculating the 

cumulative burden estimate. We have 

corrected that error here, as reflected in 

table 1. 

Dated: March 24, 2022. 

Andi Lipstein Fristedt, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs, U.S. Food and Drug 

Administration. 

[FR Doc. 2022–06661 Filed 3–29–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Application for Health Center 

Program Recipients for Deemed Public 

Health Service Employment With 

Liability Protections Under the Federal 

Tort Claims Act, 0906–0035, Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with of the 

Paperwork Reduction Act of 1995, 

HRSA has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30 day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than April 29, 2022. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Samantha Miller, the acting HRSA 

Information Collection Clearance Officer 

at paperwork@hrsa.gov or call (301) 

443–9094. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

Application for Health Center Program 

Recipients for Deemed Public Health 

Service Employment with Liability 

Protections Under the Federal Tort 

Claims Act (FTCA), OMB No. 0906– 

0035—Revision. 

Abstract: Section 224(g)–(n) of the 

Public Health Service (PHS) Act (42 

U.S.C. 233(g)–(n)), as amended, 

authorizes the ‘‘deeming’’ of entities 

receiving funds under section 330 of the 

PHS Act as PHS employees for the 

purposes of receiving FTCA coverage. 

The Health Center Program is 

administered by HRSA’s Bureau of 

Primary Health Care (BPHC). Health 

centers submit deeming applications 

annually to BPHC in the prescribed 

form and manner in order to obtain 

deemed PHS employee status for this 

purpose. 

The FTCA Program has a web-based 

application system, the Electronic 

Handbooks. These electronic 

application forms decrease the time and 

effort required to complete the older, 

paper-based OMB approved FTCA 

application forms. The application 

includes: Contact Information; Section 

1: Review of Risk Management Systems; 

Section 2: Quality Improvement/Quality 

Assurance; Section 3: Credentialing and 

Privileging; Section 4: Claims 

Management; and Section 5: Additional 

Information, Certification, and 

Signatures. 

HRSA is proposing several changes to 

the Application for Health Center 

Program Award Recipients for Deemed 

PHS Employment with Liability 

Protections under the FTCA, to be used 

for health center deeming applications 

for calendar year 2022 and thereafter, to 

clarify questions posed and required 

documentation. Specifically, the 

Application includes the following 

proposed changes: 

• Updated application language: 

Throughout the application, alternate 

terminology was utilized to provide 

greater clarity and specificity. These 

changes were based on stakeholder 

feedback and information received from 

the HRSA Health Center Program 

Support. These changes are not 

substantive in nature. 

• Some questions were removed from 

Quality Improvement/Quality 

Assurance Section, as these questions 

are similar to information that is also 

collected in the Risk Management 

Section. This change is intended to 

reduce duplicative information 

collection. 

• For the Credentialing and 

Privileging Section, in this cycle, the 

application will return to the previous 

process of submitting a Credentialing 

List with providers’ credentialing and 

privileging information. 

A 60-day notice published in the 

Federal Register, 86 Fed Reg. 72250 

(December 21, 2021). There were no 

public comments. 


khammond on DSKJM1Z7X2PROD with NOTICES

I I I I I 
18374 Federal Register / Vol. 87, No. 61 / Wednesday, March 30, 2022 / Notices 

Need and Proposed Use of the 

Information Deeming applications are 

required by law and must address 

certain specific criteria in order for 

deeming determinations to be issued. 

The application submissions provide 

BPHC with the information essential for 

evaluation of compliance with legal 

requirements and making a deeming 

determination under Section 224(g)–(n) 

of the PHS Act (42 U.S.C. 233(g)–(n)). 

Likely Respondents: Respondents 

include recipients of Health Center 

Program funds seeking deemed PHS 

employee status under Section 224(g)– 

(n) of the PHS Act (42 U.S.C. 233(g)– 

(n)). 

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 

FTCA Health Center Program Initial Application ................. 35 1 35 2.5 87.5 

FTCA Health Center Program Redeeming Application ....... 1,125 1 1,125 2.5 2,812.5 

Total .............................................................................. 1,160 ........................ 1,160 ........................ 2,900 

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. 2022–06647 Filed 3–29–22; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Advisory 

Council on Alcohol Abuse and 

Alcoholism. 

The meeting will be held as a virtual 

meeting and is open to the public. 

Individuals who plan to view the virtual 

meeting and need special assistance or 

other reasonable accommodations to 

view the meeting, should notify the 

Contact Person listed below in advance 

of the meeting. The open session will be 

videocast and can be accessed from the 

NIH Videocasting and Podcasting 

website (http://videocast.nih.gov/). 

A portion of this 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 Advisory 

Council on Alcohol Abuse and Alcoholism. 

Date: May 10, 2022. 

Closed: 11:30 a.m. to 12:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Open: 12:45 p.m. to 5:00 p.m. 

Agenda: Presentations and other business 

of the Council. 

Place: National Institutes of Health, 

National Institute on Alcohol Abuse and 

Alcoholism, 6700B Rockledge Drive, 

Bethesda, MD 20817. 

Contact Person: Abraham P. Bautista, 

Ph.D., Executive Secretary, National 

Advisory Council, Director, Office of 

Extramural Activities, National Institute on 

Alcohol Abuse and Alcoholism, National 

Institutes of Health, 6700 B Rockledge Drive, 

Room 1458, MSC 6902, Bethesda, MD 20892, 

301–443–9737, bautista@mail.nih.gov. 

Name of Committee: National Advisory 

Council on Alcohol Abuse and Alcoholism, 

National Cancer Advisory Board, and 

National Advisory Council on Drug Abuse. 

Date: May 11, 2022. 

Open: 11:00 a.m. to 3:00 p.m. 

Agenda: Presentation of NIAAA, NCI, and 

NIDA Directors’ Update, Scientific Reports, 

and other topics within the scope of the 

Collaborative Research on Addiction at NIH 

(CRAN). 

Place: National Institutes of Health, 

National Institute on Alcohol Abuse and 

Alcoholism, 6700B Rockledge Drive, 

Bethesda, MD 20817. 

Contact Person: Abraham P. Bautista, 

Ph.D., Executive Secretary, National 

Advisory Council, Director, Office of 

Extramural Activities, National Institute on 

Alcohol Abuse and Alcoholism, National 

Institutes of Health, 6700 B Rockledge Drive, 

Room 1458, MSC 6902, Bethesda, MD 20892, 

301–443–9737, bautista@mail.nih.gov. 

Paulette S. Gray, Ph.D., Director, Division 

of Extramural Activities, National Cancer 

Institute, National Institutes of Health, 9609 

Medical Center Drive, Room 7W444, 

Bethesda, MD 20892, 240–276–6340, grayp@

dea.nci.nih.gov. 

Susan Weiss, Ph.D., Director, Division of 

Extramural Research, National Institute on 

Drug Abuse, National Institutes of Health, 

6001 Executive Boulevard, NSC, Room 5274, 

Bethesda, MD 20892, 301–443–6487, sweiss@

nida.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: http://

www.niaaa.nih.gov/AboutNIAAA/Advisory

Council/Pages/default.aspx, where an agenda 

and any additional information for the 

meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.271, Alcohol Research 

Career Development Awards for Scientists 

and Clinicians; 93.272, Alcohol National 

Research Service Awards for Research 

Training; 93.273, Alcohol Research Programs; 

93.891, Alcohol Research Center Grants; 

93.701, ARRA Related Biomedical Research 

and Research Support Awards, National 

Institutes of Health, HHS) 


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