[Federal Register Volume 84, Number 195 (Tuesday, October 8, 2019)]
[Notices]
[Pages 53739-53740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21839]


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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) 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: Fax written comments on the collection of information by 
November 7, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Collection of Conflict of Interest Information for 
Participation in Food and Drug Administration Non-Employee Fellowship 
and Traineeship Programs.'' Also include the FDA docket number

[[Page 53740]]

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-NEW

    In compliance with 44 U.S.C. 3507, FDA will submit to the Office of 
Management and Budget a request to review and approve a new collection 
of information: ``Collection of Conflict of Interest Information for 
Participation in FDA Non-Employee Fellowship and Traineeship 
Programs.'' Section 742 (b) of the Food, Drug and Cosmetic Act (21 
U.S.C. 379l) allows FDA to conduct and support intramural training 
programs through fellowship and traineeship programs. These new forms 
provide the 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); (7) and service as a consultant to an FDA SRO, and/
or proprietary interest(s) in one of more product(s) regulated by FDA, 
including 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 October 22, 2018 (83 FR 53257), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although two comments were received, they 
were 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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                                                      No. of                          Average
            Activity                  No. of       responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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    Collection Form--Report of Financial Interests and Other Relationships for Non-Employee Scientists at FDA
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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.......................  ..............  ..............  ..............  ..............            1050
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information


    Dated: October 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21839 Filed 10-7-19; 8:45 am]
BILLING CODE 4164-01-P