[Federal Register Volume 85, Number 4 (Tuesday, January 7, 2020)]
[Notices]
[Pages 713-714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00039]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3885]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Center for Tobacco 
Products, Food and Drug Administration Funded Trainee/Scholar Survey

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 
February 6, 2020.

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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Center for Tobacco Products, Food and Drug Administration 
Funded Trainee/Scholar Survey.'' Also include the FDA docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
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.

Center for Tobacco Products, Food and Drug Administration Funded 
Trainee/Scholar Survey

OMB Control Number 0910-NEW

    The Tobacco Control Act (Pub. L. 111-31) amends the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) to grant FDA authority to regulate 
the manufacture, marketing, and distribution of tobacco products to 
protect the public health and to reduce tobacco use by minors.
    FDA's Center for Tobacco Products (CTP) and the National Institutes 
of Health maintain an interagency partnership to foster the development 
of the emerging field of tobacco regulatory science (TRS). This study 
will use the CTP, FDA Funded Trainee/Scholar Survey to gather data on 
the characteristics, activities, and impact of training programs funded 
by the CTP and other partners. This evaluation will also determine how 
CTP-funded research and associated training programs and activities 
increase knowledge and skills related to TRS and interest to pursue 
careers in a TRS-related field. This survey provides support to 
determine the extent to which programs and activities generate positive 
impacts to increase the number of researchers who focus on TRS and TRS-
related topics, specifically within CTP's priority domains. The survey 
builds upon previous evaluations of trainees and training activities 
and provides necessary evidence to inform FDA decision making. The web 
survey will gather responses from Tobacco Centers of Regulatory Science 
(TCORS) trainees and other CTP-funded trainees and scholars. Results 
will provide insights and directions to support future training and 
funding investments.
    FDA CTP will use findings from this study to determine whether its 
TRS training support investments lead to meaningful change that 
supports CTP aims, and to inform decisions about potential future 
investments. CTP's training support intends to build additional 
capacity for TRS that establishes an evidence base related to CTP's 
research priorities so that FDA regulations, communications, and 
application review are founded on rigorous, relevant scientific study.
    Respondents include current and former TCORS or other CTP-funded 
trainees and trainee principal investigators (PIs) or training 
directors. PIs and training directors will be asked to provide trainee 
names and email addresses and encourage trainees to participate in the 
survey. Current and former trainees will be asked to read an informed 
consent and take a brief web-based survey.
    In the Federal Register of September 12, 2019 (84 FR 48148), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
         Type of respondent/activity             Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
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                                                            Current or Former Trainee/Scholar
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Lead Letter.................................             350               1             350  0.025 (2 minutes).........................               9
Email invitation............................             350               1             350  0.016 (1 minute)..........................               6
Informed consent............................             298               1             298  0.033 (2 minutes).........................              10
Survey......................................             298               1             298  0.16 (10 minutes).........................              48
Followup email..............................             176               3             528  0.016 (1 minute)..........................               8
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                                                                 PI or Training Director
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Trainee list email..........................             350               1             350  0.16 (10 minutes).........................              56
Notification email..........................             350               1             350  0.016 (1 minute)..........................               6
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    Total...................................  ..............  ..............  ..............  ..........................................             143
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Table 1 summarizes the total annual burden hours estimated for this 
information collection. There is no cost to participants other than 
their time. The total estimated annualized burden hours are 143. A 
total of approximately 350 trainees will be invited to participate in 
the web survey. Burden hours were estimated based on experience with 
prior similar survey activities and information obtained from informal 
testing by contractor staff.

    Dated: December 31, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00039 Filed 1-6-20; 8:45 am]
 BILLING CODE 4164-01-P


