[Federal Register Volume 87, Number 240 (Thursday, December 15, 2022)]
[Notices]
[Pages 76628-76629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27194]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3728]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Collection of
Conflict-of-Interest Information for Participation in Food and Drug
Administration Non-Employee Fellowship and Traineeship Programs
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA 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 January 17, 2023.
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 0910-0882. 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.
Collection of Conflict-of-Interest Information for Participation in
Food and Drug Administration Non-Employee Fellowship and Traineeship
Programs
OMB Control Number 0910-0882--Extension
Section 742(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379l(b)) allows FDA to conduct and support intramural training
programs through fellowship and traineeship programs. Prospective
participants in these programs must complete financial disclosure forms
to determine if there is a conflict of interest that would preclude
participation. These new forms provide FDA with information about
financial investments and relationships from non-employee scientists
who participate in FDA fellowship and traineeship programs.
Participants in FDA fellowship and traineeship programs will be asked
for certain information about financial interests and current
relationships: (1) description of the financial interest; (2) the type
of financial interest (e.g., stocks, bonds, stock options); (3) if the
financial interest is an employee benefit from prior employment; (4)
value of financial interest; (5) who owns the financial interest (e.g.,
self, spouse, minor children); (6) employment relationship with an FDA
significantly regulated organization (SRO); and (7) service as a
consultant to an FDA SRO, and/or proprietary interest(s) in one of more
product(s) regulated by FDA, including a patent, trademark, copyright,
or licensing agreement. The purpose of the financial information is for
FDA to determine if there is a conflict of interest between the
Fellow's or Trainee's financial and relationship interests and their
activities at FDA. The collection of information is mandatory to
participate in FDA's fellowship and traineeship programs.
In the Federal Register of July 7, 2022 (87 FR 40537), 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Oak Ridge Institute for Science 500 1 500 1 500
and Education Fellowship.......
Traineeship Program............. 500 1 500 1 500
Reagan Udall Fellowship at FDA.. 50 1 50 1 50
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Total....................... .............. .............. .............. .............. 1,050
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
[[Page 76629]]
Dated: December 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27194 Filed 12-14-22; 8:45 am]
BILLING CODE 4164-01-P