Federal Register / Vol. 87, No. 61 / Wednesday, March 30, 2022 / Notices 18371 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: The information 

collected by the Project Impact 

Assessment Survey is needed for two 

main reasons: (1) To collect crucial 

information required to report on the 

ANA established Government 

Performance and Results Act measures, 

and (2) to properly abide by ANA’s 

congressionally mandated statute (42 

U.S.C. 2992 et seq.) found within the 

Native American Programs Act of 1974, 

as amended, which states that ANA will 

evaluate projects assisted through ANA 

grant dollars ‘‘including evaluations that 

describe and measure the impact of 

such projects, their effectiveness in 

achieving stated goals, their impact on 

related programs, and their structure 

and mechanisms for delivery of 

services.’’ The information collected 

with this survey will fulfill ANA’s 

statutory requirement and will also 

serve as an important planning and 

performance tool for ANA. 

Updates to this information collection 

address the Indian Community 

Economic Enhancement Act of 2020 

(Pub. L. 116–261). It also addresses the 

flexibilities and assistance offered under 

COVID–19 recovery assistance. 

Respondents: Tribal Governments, 

Native American nonprofit 

organizations, and Tribal Colleges and 

Universities. 

BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

ANA Project Outcome Assessment Survey .................................................. 85 1 6 510 

Estimated Total Burden Hours: 510. 

Authority: 42 U.S.C. 2992. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–06652 Filed 3–29–22; 8:45 am] 

BILLING CODE 4184–34–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0280] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Financial 

Disclosure by Clinical Investigators 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by April 29, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

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. The OMB 

control number for this information 

collection is 0910–0396. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Financial Disclosure by Clinical 

Investigators 

OMB Control Number 0910–0396— 

Extension 

Respondents to this collection are 

sponsors of marketing applications that 

contain clinical data from studies 

covered by the regulations. These 

sponsors represent pharmaceutical, 

biologic, and medical device firms. 

Respondents are also clinical 

investigators who provide financial 

information to the sponsors of 

marketing applications. 

In the Federal Register of December 2, 

2021 (86 FR 68500), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. Although one comment 

was received, it was not responsive to 

the four collection of information topics 

solicited. 

Table 1 shows information that is the 

basis of the estimated number of 

respondents in tables 2 through 4. 

TABLE 1—ESTIMATED NUMBER OF APPLICATIONS, CLINICAL TRIALS, AND INVESTIGATORS SUBJECT TO THE REGULATION

BY TYPE OF APPLICATION 1

Application type 

Total 

number of 

applications 

Number of 

applications 

affected 

Number of 

trials 

Number of 

investigators 

Drugs: 

New drug application (NDA), new molecular entity (NME) ..................... 55 55 3 to 10 ........... 3 to 100. 

NDA non-NME ......................................................................................... 78 37 3 to 10 ........... 3 to 100. 

NDA efficacy supplement ......................................................................... 196 119 1 to 3 ............. 10 to 30. 

Abbreviated new drug application (ANDA) .............................................. 821 1 1.1 .................. 2. 

ANDA supplement .................................................................................... 10,894 1 1 ..................... 2. 

CBER Biologics: 

Biologics license application (BLA) .......................................................... 10 10 3 to 10 ........... 3 to 100. 

BLA efficacy supplement ......................................................................... 30 30 1 to 3 ............. 10 to 30. 

CDER Biologics: 


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18372 Federal Register / Vol. 87, No. 61 / Wednesday, March 30, 2022 / Notices 

TABLE 1—ESTIMATED NUMBER OF APPLICATIONS, CLINICAL TRIALS, AND INVESTIGATORS SUBJECT TO THE REGULATION

BY TYPE OF APPLICATION 1—Continued 

Application type 

Total 

number of 

applications 

Number of 

applications 

affected 

Number of 

trials 

Number of 

investigators 

BLAs ......................................................................................................... 25 25 3 to 10 ........... 3 to 100. 

BLA efficacy supplements ........................................................................ 102 65 1 to 3 ............. 10 to 30. 

Medical Devices: 

Premarket approval (PMA) ...................................................................... 39 39 1 to 31 ........... 10 to 20.

PMA supplement ...................................................................................... 29 29 1 to 3 ............. 3 to 10. 

Reclassification devices ........................................................................... 0 0 0 ..................... 0.

510(k) ....................................................................................................... 3,947 247 1 ..................... 3 to 10. 

De Novo requests .................................................................................... 63 57 1 to 3 ............. 10 to 20. 

1Source: Agency estimates. 

FDA estimates the burden of this 

collection of information as follows: 

Reporting Burden 

Under § 54.4(a) (21 CFR 54.4(a)), 

applicants submitting an application 

that relies on clinical studies must 

submit a complete list of clinical 

investigators who participated in a 

covered clinical study, and must either 

certify to the absence of certain financial 

arrangements with clinical investigators 

(Form FDA 3454) or, under § 54.4(a)(3), 

disclose to FDA the nature of those 

arrangements and the steps taken by the 

applicant or sponsor to minimize the 

potential for bias (Form FDA 3455). 

FDA estimates that almost all 

applicants submit a certification 

statement under § 54.4(a)(1) and (2). 

Preparation of the statement using Form 

FDA 3454 should require no more than 

1 hour per study. The number of 

respondents is based on the estimated 

number of affected applications. 

When certification is not possible and 

disclosure is made using Form FDA 

3455, the applicant must describe, 

under § 54.4(a)(3), the financial 

arrangements or interests and the steps 

that were taken to minimize the 

potential for bias in the affected study. 

As the applicant would be fully aware 

of those arrangements and the steps 

taken to address them, describing them 

will be straightforward. The Agency 

estimates that it will take about 5 hours 

to prepare this narrative. Based on our 

experience with this collection, FDA 

estimates that approximately 10 percent 

of the respondents with affected 

applications will submit disclosure 

statements. 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Certification—54.4(a)(1) and (2)—Form FDA 3454 ............ 715 1 715 1 715 

Disclosure—54.4(a)(3)—Form FDA 3455 ........................... 72 1 72 5 360 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,075 

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

Recordkeeping Burden 

Under § 54.6 (21 CFR 54.6), the 

sponsors of covered studies must 

maintain complete records of 

compensation agreements with any 

compensation paid to nonemployee 

clinical investigators, including 

information showing any financial 

interests held by the clinical 

investigator, for 2 years after the date of 

approval of the applications. Sponsors 

of covered studies maintain many 

records regarding clinical investigators, 

including protocol agreements and 

investigator re ́sume ́s or curriculum 

vitae. FDA estimates than an average of 

15 minutes will be required for each 

recordkeeper to add this record to the 

clinical investigators’ file. 

TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 2

Recordkeeping—54.6 .......................................................... 715 1 715 0.25 179 

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

2 Numbers have been rounded. 

Third-Party Disclosure Burden 

Under § 54.4(b), clinical investigators 

supply to the sponsor of a covered study 

financial information sufficient to allow 

the sponsor to submit complete and 

accurate certification or disclosure 

statements. Clinical investigators are 

accustomed to supplying such 

information when applying for research 

grants. Also, most people know the 

financial holdings of their immediate 

family, and records of such interests are 

generally accessible because they are 

needed for preparing tax records. For 

these reasons, FDA estimates that the 


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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. 


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