[Federal Register Volume 84, Number 177 (Thursday, September 12, 2019)]
[Notices]
[Pages 48148-48149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19751]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Center for Tobacco Products, Food and Drug 
Administration Funded Trainee/Scholar Survey

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on ``Center for Tobacco Products, Food and Drug 
Administration Funded Trainee/Scholar Survey.''

DATES: Submit either electronic or written comments on the collection 
of information by November 12, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 12, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-N-3885 for ``Center for Tobacco Products, Food and Drug 
Administration Funded Trainee/Scholar Survey.'' Received comments, 
those filed in a timely manner (see ADDRESSES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601

[[Page 48149]]

Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
  Type of respondent/activity      Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
                                        Current or Former Trainee/Scholar
----------------------------------------------------------------------------------------------------------------
Lead Letter...................             350               1             350  .025 (2 minutes)               9
Email invitation..............             350               1             350  .016 (1 minute).               6
Informed consent..............             298               1             298  .033 (2 minutes)              10
Survey........................             298               1             298  .16 (10 minutes)              48
Followup email................             176               3             528  .016 (1 minute).               8
----------------------------------------------------------------------------------------------------------------
                                             PI or Training Director
----------------------------------------------------------------------------------------------------------------
Trainee list email............             350               1             350  .16 (10 minutes)              56
Notification email............             350               1             350  .016 (1 minute).               6
                               ------------------------------------------------                  ---------------
    Total.....................  ..............  ..............  ..............  ................             143
----------------------------------------------------------------------------------------------------------------
\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: September 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19751 Filed 9-11-19; 8:45 am]
 BILLING CODE 4164-01-P