[Federal Register Volume 89, Number 230 (Friday, November 29, 2024)]
[Notices]
[Pages 94735-94738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28034]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4754]
Agency Information Collection Activities; Proposed Collection;
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of
[[Page 94736]]
certain information by the Agency. Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on financial disclosure by
clinical investigators.
DATES: Either electronic or written comments on the collection of
information must be submitted by January 28, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 28, 2025. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2024-N-4754 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Financial Disclosure by Clinical
Investigators.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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.
[[Page 94737]]
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 application 26 26 3 to 10.............. 3 to 100.
(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)........................ 3401 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 applications
will submit disclosure statements.
Table 2--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Certification--54.4(a)(1) and (2)--Form FDA 3454................. 712 1 712 1 712
Disclosure--54.4(a)(3)--Form FDA 3455............................ 71 1 71 5 355
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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.
[[Page 94738]]
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: November 19, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-28034 Filed 11-27-24; 8:45 am]
BILLING CODE 4164-01-P