Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators, 18371-18373 [2022-06661]

Download as PDF 18371 Federal Register / Vol. 87, No. 61 / Wednesday, March 30, 2022 / Notices 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. 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 SUMMARY: (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 Total number of applications khammond on DSKJM1Z7X2PROD with NOTICES Application type Drugs: New drug application (NDA), new molecular entity (NME) ..................... NDA non-NME ......................................................................................... NDA efficacy supplement ......................................................................... Abbreviated new drug application (ANDA) .............................................. ANDA supplement .................................................................................... CBER Biologics: Biologics license application (BLA) .......................................................... BLA efficacy supplement ......................................................................... CDER Biologics: VerDate Sep<11>2014 17:14 Mar 29, 2022 Jkt 256001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 Number of applications affected Number of trials Number of investigators 55 78 196 821 10,894 55 37 119 1 1 3 to 10 ........... 3 to 10 ........... 1 to 3 ............. 1.1 .................. 1 ..................... 3 to 100. 3 to 100. 10 to 30. 2. 2. 10 30 10 30 3 to 10 ........... 1 to 3 ............. 3 to 100. 10 to 30. E:\FR\FM\30MRN1.SGM 30MRN1 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 Total number of applications Application type BLAs ......................................................................................................... BLA efficacy supplements ........................................................................ Medical Devices: Premarket approval (PMA) ...................................................................... PMA supplement ...................................................................................... Reclassification devices ........................................................................... 510(k) ....................................................................................................... De Novo requests .................................................................................... 1 Source: Number of applications affected 25 102 25 65 39 29 0 3,947 63 39 29 0 247 57 Number of trials Number of investigators 3 to 10 ........... 1 to 3 ............. 3 to 100. 10 to 30. 1 1 0 1 1 10 to 20. 3 to 10. 0. 3 to 10. 10 to 20. to 31 ........... to 3 ............. ..................... ..................... to 3 ............. 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 Number of respondents 21 CFR section Number of responses per respondent Average burden per response Total annual responses Total hours Certification—54.4(a)(1) and (2)—Form FDA 3454 ............ Disclosure—54.4(a)(3)—Form FDA 3455 ........................... 715 72 1 1 715 72 1 5 715 360 Total .............................................................................. ........................ ........................ ........................ ........................ 1,075 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Recordkeeping Burden 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, 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 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 khammond on DSKJM1Z7X2PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. have been rounded. 2 Numbers 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 VerDate Sep<11>2014 17:14 Mar 29, 2022 Jkt 256001 accurate certification or disclosure statements. Clinical investigators are accustomed to supplying such information when applying for research grants. Also, most people know the PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 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 E:\FR\FM\30MRN1.SGM 30MRN1 18373 Federal Register / Vol. 87, No. 61 / Wednesday, March 30, 2022 / Notices 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 54.4(b)—Clinical Investigators ............................................. 1 There Number of disclosures per respondent Number of respondents 21 CFR section I 13,082 I 1 Average burden per disclosure Total annual disclosures I 13,082 I 0.17 Total hours 2 I 2,224 are no capital costs or operating and maintenance costs associated with this collection of information. have been rounded. 2 Numbers 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 khammond on DSKJM1Z7X2PROD with NOTICES 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 Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of SUMMARY: VerDate Sep<11>2014 17:14 Mar 29, 2022 Jkt 256001 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 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 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. E:\FR\FM\30MRN1.SGM 30MRN1

Agencies

[Federal Register Volume 87, Number 61 (Wednesday, March 30, 2022)]
[Notices]
[Pages 18371-18373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06661]


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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, 
[email protected].

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\
----------------------------------------------------------------------------------------------------------------
                                   Total number      Number of
        Application type                of         applications      Number of trials            Number of
                                   applications      affected                                  investigators
----------------------------------------------------------------------------------------------------------------
Drugs:
    New drug application (NDA),               55              55  3 to 10...............  3 to 100.
     new molecular entity (NME).
    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                     821               1  1.1...................  2.
     application (ANDA).
    ANDA supplement.............          10,894               1  1.....................  2.
CBER Biologics:
    Biologics license                         10              10  3 to 10...............  3 to 100.
     application (BLA).
    BLA efficacy supplement.....              30              30  1 to 3................  10 to 30.
CDER Biologics:

[[Page 18372]]

 
    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.
----------------------------------------------------------------------------------------------------------------
\1\ Source: Agency estimates.

    FDA estimates the burden of this collection of information as 
follows:

Reporting Burden

    Under Sec.  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 
Sec.  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 Sec.  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 Sec.  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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Certification--54.4(a)(1) and                715               1             715               1             715
 (2)--Form FDA 3454.............
Disclosure--54.4(a)(3)--Form FDA              72               1              72               5             360
 3455...........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,075
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

Recordkeeping Burden

    Under Sec.  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 r[eacute]sum[eacute]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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                       Average burden
                           21 CFR section                               Number of       records per      Total annual         per        Total hours \2\
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping--54.6................................................             715                1              715             0.25              179
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There 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 Sec.  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

[[Page 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                           21 CFR section                               Number of     disclosures per    Total annual    Average burden  Total hours \2\
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
54.4(b)--Clinical Investigators....................................          13,082                1           13,082             0.17            2,224
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There 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