[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


