87 FR 240 pgs. 76628-76629 - 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
Type: NOTICEVolume: 87Number: 240Pages: 76628 - 76629
Pages: 76628, 76629Docket number: [Docket No. FDA-2018-N-3728]
FR document: [FR Doc. 2022-27194 Filed 12-14-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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, PRAStaff@fda.hhs.gov.
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:
| Activity | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| Oak Ridge Institute for Science and Education Fellowship | 500 | 1 | 500 | 1 | 500 |
| Traineeship Program | 500 | 1 | 500 | 1 | 500 |
| Reagan Udall Fellowship at FDA | 50 | 1 | 50 | 1 | 50 |
| Total | 1,050 | ||||
| 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.
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Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27194 Filed 12-14-22; 8:45 am]
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