[Federal Register Volume 90, Number 83 (Thursday, May 1, 2025)]
[Notices]
[Pages 18685-18686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-07577]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4754]
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.
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SUMMARY: The Food and Drug Administration (FDA) 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 June 2, 2025.
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.
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\
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Total number Number of
Application type of applications Number of trials Number of
applications affected investigators
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Drugs:
New drug application (NDA), 35 35 3 to 10............... 3 to 100.
new molecular entity (NME).
NDA non-NME................. 94 44 3 to 10............... 3 to 100.
NDA efficacy supplement..... 171 100 1 to 3................ 10 to 30.
Abbreviated new drug 685 1 1.1................... 2.
application (ANDA).
ANDA supplement............. 10,366 1 1..................... 2.
CBER Biologics:
Biologics license 26 26 3 to 10............... 3 to 100.
application (BLA).
BLA efficacy supplement..... 26 26 1 to 3................ 10 to 30.
CDER Biologics:
BLAs........................ 19 19 3 to 10............... 3 to 100.
BLA efficacy supplements.... 64 50 1 to 3................ 10 to 30.
Medical Devices:
Premarket approval (PMA).... 43 50 1 to 31............... 10 to 20.
PMA supplement.............. 28 30 to 3.................. 3 to 10
Reclassification devices.... 0 0 0..................... 0.
510(k)...................... 3,401 254 1..................... 3 to 10.
De Novo requests............ 84 76 1 to 3................ 10 to 20.
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\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
[[Page 18686]]
applications will submit disclosure statements.
In the Federal Register of November 29, 2024 (89 FR 94735), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received but was not PRA
related.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden \1\
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Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
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Certification--54.4(a)(1) and 712 1 712 1 712
(2)--Form FDA 3454...........
Disclosure--54.4(a)(3)--Form 71 1 71 5 355
FDA 3455.....................
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Total..................... ............... ............... .............. .............. 1,067
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\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 resumes or curriculum vitae. FDA estimates 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\
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Number of Average burden
21 CFR section Number of records per Total annual per Total hours \2\
recordkeepers recordkeeper records recordkeeping
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Recordkeeping--54.6.............................................. 712 1 712 0.25 178
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\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 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
4). To estimate the number of respondents for each FDA Center, we took
the median number of investigators for each application type,
multiplied each median number of investigators by the number of
affected applications for that application type, then summed those
products to get the total number of respondents for the Center.
Table 4--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
21 CFR section Number of disclosures per Total annual Average burden Total hours \2\
respondents respondent disclosures per disclosure
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54.4(b)--Clinical Investigators.................................. 13,646 1 13,646 0.17 2,320
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\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. We have adjusted our estimated burden for
the information collection to reflect the number of submissions we
received in the last few years. These adjustments result in an increase
of 557 total annual responses and a corresponding increase of 87 total
hours.
Dated: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07577 Filed 4-30-25; 8:45 am]
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