Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications, 44779-44780 [2014-18195]
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Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices
C. Authority for Conducting the Match
The authority for conducting the
matching program is contained in
section 453(j)(10) of the Social Security
Act (42 U.S.C. 653(j)(10)). The
Agriculture Act of 2014, Pub. L. 113–
079, amended section 11(e) of the Food
and Nutrition Act of 2008 (7 U.S.C.
2020(e)(24)) by adding the requirement
that the State agency shall request wage data
directly from the National Directory of New
Hires established under section 453(i) of the
Social Security Act (42 U.S.C. 653(i)) relevant
to determining eligibility to receive
supplemental nutrition assistance program
benefits and determining the correct amount
of those benefits at the time of certification;
tkelley on DSK3SPTVN1PROD with NOTICES
D. Categories of Individuals Involved
and Identification of Records Used in
the Matching Program
The categories of individuals involved
in the matching program are adult
members of households that receive or
have applied for SNAP benefits. The
system of records maintained by OCSE
from which records will be disclosed for
the purpose of this matching program is
the ‘‘OCSE National Directory of New
Hires’’ (NDNH), No. 09–80–0381, last
published in the Federal Register at 76
FR 560, January 5, 2011. The NDNH
contains new hire, quarterly wage, and
unemployment insurance information.
The disclosure of NDNH information by
OCSE to the state agencies
administering SNAP is a ‘‘routine use’’
under this system of records. Records
resulting from the matching program
and which are disclosed to state
agencies administering SNAP include
names, Social Security numbers, home
addresses, and employment
information.
E. Inclusive Dates of the Matching
Program
The computer matching agreement
will be effective and matching activity
may commence the later of the
following:
(1) 30 days after this notice is
published in the Federal Register or (2)
40 days after OCSE sends a report of the
matching program to the Congressional
committees of jurisdiction under 5
U.S.C. 552a(o)(2)(A), and to OMB,
unless OMB disapproves the agreement
within the 40-day review period or
grants a waiver of 10 days of the 40-day
review period. The matching agreement
will remain in effect for 18 months from
its effective date, unless one of the
parties to the agreement advises the
other by written request to terminate or
modify the agreement. The agreement is
subject to renewal by the HHS Data
Integrity Board for 12 additional months
if the matching program will be
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22:09 Jul 31, 2014
Jkt 232001
conducted without any change and
OCSE and the state agency certify to the
Data Integrity Board in writing that the
program has been conducted in
compliance with the agreement.
[FR Doc. 2014–18245 Filed 7–31–14; 8:45 am]
BILLING CODE 4184–42–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0005]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Generic Clearance
for the Collection of Qualitative Data
on Tobacco Products and
Communications
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
Generic Clearance for the Collection of
Qualitative Data on Tobacco Products
and Communications.
DATES: Submit either electronic or
written comments on the collection of
information by September 30, 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.
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
44779
‘‘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.
Generic Clearance for the Collection of
Qualitative Data on Tobacco Products
and Communications (OMB Control
Number 0910—NEW)
Under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 393(d)(2)(D)),
FDA is authorized to conduct
educational and public information
programs.
In conducting studies relating to the
regulation and communications related
to tobacco products, FDA will need to
employ formative qualitative research
including focus groups and/or in-depth
interviews (IDIs) to assess knowledge
and perceptions about tobacco-related
topics with specific target audiences.
The information collected will serve
two major purposes. First, formative
research will provide critical knowledge
about target audiences. FDA must first
understand people’s knowledge and
perceptions about tobacco related topics
prior to developing survey/research
questions as well as stimuli for
experimental studies. Second, initial
testing will allow FDA to assess
consumer understanding of survey/
research questions and study stimuli.
Focus groups and/or IDIs with a sample
of the target audience will allow FDA to
refine the survey/research questions and
E:\FR\FM\01AUN1.SGM
01AUN1
44780
Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices
study stimuli while they are still in the
developmental stage. FDA will collect,
analyze, and interpret information
gathered through this generic clearance
in order to: (1) Better understand
characteristics of the target audience—
its perceptions, knowledge, attitudes,
beliefs, and behaviors—and use these in
the development of appropriate survey/
research questions, study stimuli or
communications; (2) more efficiently
and effectively design survey/research
questions and study stimuli; and (3)
more efficiently and effectively design
experimental studies.
FDA is requesting approval of this
new generic for collecting information
through the use of qualitative methods
(i.e., individual interviews, small group
discussions and focus groups) for
studies involving all tobacco products
regulated by FDA. This information will
be used as a first step to explore
concepts of interest and assist in the
development of quantitative study
proposals, complementing other
important research efforts in the
Agency. This information may also be
used to help identify and develop
communication messages, which may
be used in education campaigns. Focus
groups play an important role in
gathering information because they
allow for an in-depth understanding of
individuals’ attitudes, beliefs,
motivations, and feelings. Focus group
research serves the narrowly defined
need for direct and informal public
opinion on a specific topic.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
In Person Individual In-Depth Interviews ........................
General Public Focus Group Interviews .........................
Telephone Screening Interviews .....................................
Telephone Individual In-Depth Interviews .......................
350
18,850
4,800
50
Total .........................................................................
Total
annual
responses
Dated: July 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–18195 Filed 7–31–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0996]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry: Fast Track Drug
Development Programs: Designation,
Development, and Application Review
Food and Drug Administration,
HHS.
ACTION:
350
18,850
4,800
50
Total hours
1 .........................
1.5 ......................
.08 (5 minutes) ...
1 .........................
350
28,275
384
50
........................
29,059
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 pretest may vary,
depending on the nature of the material
or message being tested and the target
audience. Table 1 provides examples of
the types of studies that may be
administered and estimated burden
levels during the 3-year period. Time to
read, view, or listen to the message
being tested is built into the ‘‘Hours Per
Response’’ figures.
AGENCY:
1
1
1
1
Hours per
response
24,050
1 There
tkelley on DSK3SPTVN1PROD with NOTICES
Number of
responses
per
respondent
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
SUMMARY:
VerDate Mar<15>2010
22:09 Jul 31, 2014
Jkt 232001
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, 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 proposed collection of information
concerning requests by sponsors of
investigational new drugs and
applicants for new drug or biologics
licenses for fast track designation as
provided in the Guidance for Industry
on Fast Track Drug Development
Programs: Designation, Development,
and Application Review.
DATES: Submit either electronic or
written comments on the collection of
information by September 30, 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
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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,
including each proposed extension of an
existing 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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\01AUN1.SGM
01AUN1
]]>Agencies
[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44779-44780]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18195]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0005]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Clearance for the Collection of Qualitative
Data on Tobacco Products and Communications
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 Generic Clearance for the Collection of
Qualitative Data on Tobacco Products and Communications.
DATES: Submit either electronic or written comments on the collection
of information by September 30, 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.
Generic Clearance for the Collection of Qualitative Data on Tobacco
Products and Communications (OMB Control Number 0910--NEW)
Under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
393(d)(2)(D)), FDA is authorized to conduct educational and public
information programs.
In conducting studies relating to the regulation and communications
related to tobacco products, FDA will need to employ formative
qualitative research including focus groups and/or in-depth interviews
(IDIs) to assess knowledge and perceptions about tobacco-related topics
with specific target audiences. The information collected will serve
two major purposes. First, formative research will provide critical
knowledge about target audiences. FDA must first understand people's
knowledge and perceptions about tobacco related topics prior to
developing survey/research questions as well as stimuli for
experimental studies. Second, initial testing will allow FDA to assess
consumer understanding of survey/research questions and study stimuli.
Focus groups and/or IDIs with a sample of the target audience will
allow FDA to refine the survey/research questions and
[[Page 44780]]
study stimuli while they are still in the developmental stage. FDA will
collect, analyze, and interpret information gathered through this
generic clearance in order to: (1) Better understand characteristics of
the target audience--its perceptions, knowledge, attitudes, beliefs,
and behaviors--and use these in the development of appropriate survey/
research questions, study stimuli or communications; (2) more
efficiently and effectively design survey/research questions and study
stimuli; and (3) more efficiently and effectively design experimental
studies.
FDA is requesting approval of this new generic for collecting
information through the use of qualitative methods (i.e., individual
interviews, small group discussions and focus groups) for studies
involving all tobacco products regulated by FDA. This information will
be used as a first step to explore concepts of interest and assist in
the development of quantitative study proposals, complementing other
important research efforts in the Agency. This information may also be
used to help identify and develop communication messages, which may be
used in education campaigns. Focus groups play an important role in
gathering information because they allow for an in-depth understanding
of individuals' attitudes, beliefs, motivations, and feelings. Focus
group research serves the narrowly defined need for direct and informal
public opinion on a specific topic.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Hours per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Person Individual In-Depth Interviews....... 350 1 350 1...................................... 350
General Public Focus Group Interviews.......... 18,850 1 18,850 1.5.................................... 28,275
Telephone Screening Interviews................. 4,800 1 4,800 .08 (5 minutes)........................ 384
Telephone Individual In-Depth Interviews....... 50 1 50 1...................................... 50
--------------------------------------------------------------------------------------------------------
Total...................................... 24,050 .............. .............. ....................................... 29,059
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 pretest may
vary, depending on the nature of the material or message being tested
and the target audience. Table 1 provides examples of the types of
studies that may be administered and estimated burden levels during the
3-year period. Time to read, view, or listen to the message being
tested is built into the ``Hours Per Response'' figures.
Dated: July 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18195 Filed 7-31-14; 8:45 am]
BILLING CODE 4164-01-P
