Document ID: FDA-2012-N-0280-0012
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators
Posted Date: 2022-03-30T04:00Z

[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]

-----------------------------------------------------------------------

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