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, 713-714 [2020-00039]
Download as PDF
<![CDATA[
Federal Register / Vol. 85, No. 4 / Tuesday, January 7, 2020 / Notices
Estimated Total Annual Burden
Hours: 387.
Authority: Section 680(a)(2) of the
Community Services Block Grant (CSBG)
Act, 42 U.S.C. 9921.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–00007 Filed 1–6–20; 8:45 am]
BILLING CODE 4184–01–P
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.
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
SUMMARY:
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 TRSrelated field. This survey provides
713
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 webbased 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
Number of
respondents
Type of respondent/activity
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
khammond on DSKJM1Z7X2PROD with NOTICES
Current or Former Trainee/Scholar
Lead Letter ...............................................................
Email invitation .........................................................
Informed consent .....................................................
Survey ......................................................................
Followup email .........................................................
350
350
298
298
176
1
1
1
1
3
350
350
298
298
528
0.025 (2
0.016 (1
0.033 (2
0.16 (10
0.016 (1
minutes) ......
minute) ........
minutes) ......
minutes) ......
minute) ........
9
6
10
48
8
1
1
350
350
0.16 (10 minutes) ......
0.016 (1 minute) ........
56
6
PI or Training Director
Trainee list email ......................................................
Notification email ......................................................
VerDate Sep<11>2014
16:15 Jan 06, 2020
Jkt 250001
PO 00000
350
350
Frm 00045
Fmt 4703
Sfmt 4703
E:\FR\FM\07JAN1.SGM
07JAN1
714
Federal Register / Vol. 85, No. 4 / Tuesday, January 7, 2020 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Type of respondent/activity
Total ..................................................................
1 There
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0597]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Index of Legally
Marketed Unapproved New Animal
Drugs for Minor Species
Food and Drug Administration,
HHS.
ACTION:
Notice.
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,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of our regulations
related to public index listing of legally
marketed unapproved new animal drugs
for minor species of animals.
DATES: Submit either electronic or
written comments on the collection of
information by March 9, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Total annual
responses
Average burden per
response
........................
........................
........................
....................................
Total hours
143
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.
AGENCY:
Number of
respondents
VerDate Sep<11>2014
16:15 Jan 06, 2020
Jkt 250001
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before March 9,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 9, 2020. 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
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2010–N–0597 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Index of
Legally Marketed Unapproved New
Animal Drugs for Minor Species.’’
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.govinfo.gov/content/pkg/FR-201509-18/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
E:\FR\FM\07JAN1.SGM
07JAN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 [email protected]. 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,
[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.
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of respondent/activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Current or Former Trainee/Scholar
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
PI or Training Director
--------------------------------------------------------------------------------------------------------------------------------------------------------
Trainee list email.......................... 350 1 350 0.16 (10 minutes)......................... 56
Notification email.......................... 350 1 350 0.016 (1 minute).......................... 6
-----------------------------------------------------------------------------------------------------------
[[Page 714]]
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: 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
