Agency Information Collection Activities; Proposed Collection; Comment Request; Quantitative Testing as Used by the Food and Drug Administration Center for Tobacco Products, 41696-41697 [2014-16795]
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Federal Register / Vol. 79, No. 137 / Thursday, July 17, 2014 / Notices
antimicrobial resistance. Action items
were organized into focus areas:
Surveillance, Prevention and Control,
Research, and Product Development.
The 2001 Action Plan was revised in
2011 and 2012 to address the evolving
threat of antimicrobial resistance. A
revised draft of the Action Plan is under
development and will be available for
public comment later this year.
pmangrum on DSK3VPTVN1PROD with NOTICES
2. Public Comment and Meeting
The public meeting process provides
an opportunity for the public to
comment on the activities of the ITFAR
to date. The agenda will consist of
welcome and introductory comments
followed by sessions centering on
specific topics in each of the three focus
areas of the Action Plan: Surveillance,
Prevention and Control of Antimicrobial
Resistance; Research; and Regulatory
Pathways to Promote Product
Development. Each session will include
presentations by the ITFAR members on
the strategic direction of government
agencies for that Focus Area followed by
brief presentations from invited partner
organizations. The session will end with
a moderated question and answer
session with the audience. The meeting
will then be open for comments from
the general public. The agenda is subject
to change without notice.
Comments and suggestions from the
public on the ITFAR or any of the focus
areas of the Action Plan will be
reviewed and carefully considered by
the ITFAR. The public should be aware
that this meeting agenda does not
include development of consensus
positions, guidelines, interrogatories, or
discussions or endorsement of specific
commercial products.
3. Registration To Attend or Participate
in the Public Meeting
Participants are asked to preregister to
ensure sufficient space. Seating capacity
is limited to 200 persons. To register,
please send an electronic mail message
to ITFAR@cdc.gov by 12:00 p.m. EDT,
Monday, August 18, 2014. Your email
should include your name, and email
address. Because of time restrictions,
the moderated question and answer
session with the audience and the time
for comments from the general public
will be limited by the time allotted on
the agenda. However, additional
comments may be submitted in writing
following the public meeting;
instructions for submission are listed in
ADDRESSES.
4. Building and Security Guidelines
The meeting is being held in a Federal
government building; therefore, Federal
security measures are applicable. In
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15:01 Jul 16, 2014
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planning your arrival, please take into
account the need to clear security. All
visitors entering the Ronald Reagan
Building must procede as directed
through security checkpoints and
present government-issued photo
identification (e.g., a valid Federal
identification badge, state driver’s
license, state non-driver’s license, or
passport). All visitors entering the
building must pass through a metal
detector. All items brought to Ronald
Reagan Building may be subject to
inspection.
Dated: July 14, 2014.
Ron A. Otten,
Acting Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2014–16790 Filed 7–16–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0987]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Quantitative
Testing as Used by the Food and Drug
Administration Center for Tobacco
Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
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
quantitative testing as used by the Food
and Drug Administration Center for
Tobacco Products.
DATES: Submit either electronic or
written comments on the collection of
information by September 15, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
SUMMARY:
PO 00000
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docket number found in brackets in the
heading of this document.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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.
SUPPLEMENTARY INFORMATION:
Quantitative Testing as Used by the
Food and Drug Administration Center
for Tobacco Products (OMB Control
Number 0910—NEW)
In order to conduct educational and
public information programs relating to
tobacco use as authorized by section
1003(d)(2)(D) of the Federal Food Drug
and Cosmetic Act (21 U.S.C.
393(d)(2)(D)), FDA’s Center for Tobacco
Products will create and use a variety of
media to inform and educate the public,
tobacco retailers, and health
professionals about the risks of tobacco
use, how to quit using tobacco products,
and FDA’s role in regulating tobacco.
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Federal Register / Vol. 79, No. 137 / Thursday, July 17, 2014 / Notices
To ensure that such health
communication messages have the
highest potential to be received,
understood, and are accepted by those
for whom they are intended, FDA’s
Center for Tobacco Products will
conduct research and studies relating to
the control and prevention of disease. In
conducting such research, FDA will
employ formative pretests. Formative
pretests are conducted on a small scale,
and their focus is on developing and
assessing the likely effectiveness of
communications with specific target
audiences. This type of research
involves (1) assessing audience
knowledge, attitudes, behaviors, and
other characteristics for the purpose of
determining the need for and
developing health messages,
communication strategies, and public
information programs; and (2) pretesting
these health messages, strategies, and
program components while they are in
developmental form to assess audience
comprehension, reactions, and
perceptions.
Formative pretesting is a staple of best
practices in communications research.
Obtaining feedback from intended
audiences during the development of
messages and materials is crucial for the
success of every communication
program. The purpose of obtaining
information from formative pretesting is
that it allows FDA to improve materials
and strategies while revisions are still
affordable and possible. Formative
pretesting can also avoid potentially
expensive and dangerous unintended
outcomes caused by audiences’
interpreting messages in a way that was
not intended by the drafters. By
maximizing the effectiveness of
41697
messages and strategies for reaching
targeted audiences, the frequency with
which tobacco communication messages
need to be modified should be greatly
reduced.
The information collected will serve
the primary purpose of providing FDA
information about the perceived
effectiveness of messages,
advertisements, and materials in
reaching and successfully
communicating with their intended
audiences. Quantitative testing
messages and other materials with a
sample of the target audience will allow
FDA to refine messages, advertisements,
and materials, including questionnaires
or images, directed at consumers while
they are still in the developmental stage.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
Self-Administered Surveys ...................................
30,300
1
30,300
0.33 (20 minutes) ..........
9,999
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents to be
included in each new survey will vary,
depending on the nature of the material
or message being tested and the target
audience.
Dated: July 14, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–16795 Filed 7–16–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Food Advisory Committee; Notice of
Meeting
AGENCY:
Food and Drug Administration,
HHS.
pmangrum on DSK3VPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory of the Food
and Drug Administration (FDA). The
meeting will be open to the public.
Name of Committee: Food Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
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17:31 Jul 16, 2014
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Date and Time: The meeting will be
held on September 29 and 30, 2014,
from 8:30 a.m. to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503A), Silver Spring, MD 20993–0002.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Karen Strambler,
Center for Food Safety and Applied
Nutrition, Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–2589 or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area). A notice in the Federal Register
about last minute modifications that
impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the Agency’s Web
site at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
PO 00000
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Fmt 4703
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advisory committee information line to
learn about possible modifications
before coming to the meeting. If you are
unable to join us in person, we
encourage you to watch the Web cast.
Visit the Food Advisory Committee Web
site at https://www.fda.gov/
AdvisoryCommittees/
CommitteesMeetingMaterials/
FoodAdvisoryCommittee/default.htm.
The link will become active shortly
before the open session begins at 8:30
a.m.
Agenda: The Food Advisory
Committee will discuss risk ranking and
risk prioritization approaches for
specific regulatory purposes. The
Committee will provide input to FDA in
the development of the characteristics
for data collections and risk ranking/risk
prioritization models. These
characteristics would be useful in
framing the fundamental elements
needed to design or evaluate FDA’s food
and veterinary programs.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
E:\FR\FM\17JYN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 137 (Thursday, July 17, 2014)]
[Notices]
[Pages 41696-41697]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16795]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0987]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Quantitative Testing as Used by the Food and Drug
Administration Center for Tobacco Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 quantitative testing as used by the Food
and Drug Administration Center for Tobacco Products.
DATES: Submit either electronic or written comments on the collection
of information by September 15, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
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.
Quantitative Testing as Used by the Food and Drug Administration Center
for Tobacco Products (OMB Control Number 0910--NEW)
In order to conduct educational and public information programs
relating to tobacco use as authorized by section 1003(d)(2)(D) of the
Federal Food Drug and Cosmetic Act (21 U.S.C. 393(d)(2)(D)), FDA's
Center for Tobacco Products will create and use a variety of media to
inform and educate the public, tobacco retailers, and health
professionals about the risks of tobacco use, how to quit using tobacco
products, and FDA's role in regulating tobacco.
[[Page 41697]]
To ensure that such health communication messages have the highest
potential to be received, understood, and are accepted by those for
whom they are intended, FDA's Center for Tobacco Products will conduct
research and studies relating to the control and prevention of disease.
In conducting such research, FDA will employ formative pretests.
Formative pretests are conducted on a small scale, and their focus is
on developing and assessing the likely effectiveness of communications
with specific target audiences. This type of research involves (1)
assessing audience knowledge, attitudes, behaviors, and other
characteristics for the purpose of determining the need for and
developing health messages, communication strategies, and public
information programs; and (2) pretesting these health messages,
strategies, and program components while they are in developmental form
to assess audience comprehension, reactions, and perceptions.
Formative pretesting is a staple of best practices in
communications research. Obtaining feedback from intended audiences
during the development of messages and materials is crucial for the
success of every communication program. The purpose of obtaining
information from formative pretesting is that it allows FDA to improve
materials and strategies while revisions are still affordable and
possible. Formative pretesting can also avoid potentially expensive and
dangerous unintended outcomes caused by audiences' interpreting
messages in a way that was not intended by the drafters. By maximizing
the effectiveness of messages and strategies for reaching targeted
audiences, the frequency with which tobacco communication messages need
to be modified should be greatly reduced.
The information collected will serve the primary purpose of
providing FDA information about the perceived effectiveness of
messages, advertisements, and materials in reaching and successfully
communicating with their intended audiences. Quantitative testing
messages and other materials with a sample of the target audience will
allow FDA to refine messages, advertisements, and materials, including
questionnaires or images, directed at consumers while they are still in
the developmental stage.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Self-Administered Surveys....................... 30,300 1 30,300 0.33 (20 minutes)................. 9,999
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents to be included in each new survey will
vary, depending on the nature of the material or message being tested
and the target audience.
Dated: July 14, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-16795 Filed 7-16-14; 8:45 am]
BILLING CODE 4164-01-P
