Agency Information Collection Activities; Proposed Collection; Comment Request; Pretesting of Tobacco Communications, 9225-9226 [2010-4098]
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9225
Federal Register / Vol. 75, No. 39 / Monday, March 1, 2010 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses
per
respondent
Average
burden per
response
(in hours)
Intake Questionnaire ................................
230,000
1
1/60
3,833
...................................................................
500,000
1
10/60
83,333
Follow-up Questionnaire ..........................
28,900
1
7/60
3,372
Quitline Services Questionnaire ...............
52
4
7/60
24
...................................................................
....................
....................
....................
90,562
Type of respondent
Form name
Caller who contacts the Quitline on behalf
of someone else.
Caller who contacts the Quitline for personal use.
Quitline caller who received a Quitline
service.
Tobacco Control Manager ........................
Total ...................................................
Dated: February 23, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–4164 Filed 2–26–10; 8:45 am]
BILLING CODE 4163–18–P
Food and Drug Administration
[Docket No. FDA–2010–N–0084]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Pretesting of
Tobacco Communications
Food and Drug Administration,
HHS.
mstockstill on DSKH9S0YB1PROD with NOTICES
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
pretesting of tobacco communications.
DATES: Submit written or electronic
comments on the collection of
information by April 30, 2010.
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.
VerDate Nov<24>2008
16:46 Feb 26, 2010
Jkt 220001
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:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794, e-mail: Jonnalynn.capezzuto@fda.
hhs.gov.
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
Total
burden
(in hours)
Pretesting of Tobacco Communications
In order to conduct educational and
public information programs relating to
tobacco use, as authorized by section
903(d)(2)(D) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
393(d)(2)(D)) and to develop stronger
health warnings on tobacco packaging
as authorized by the Family Smoking
Prevention and Tobacco Control Act
(Tobacco Control Act), it is beneficial
for FDA to conduct research and studies
relating to the control and prevention of
disease as authorized by section 301 of
the Public Health Service Act (42 U.S.C
241(a)). In conducting such research,
FDA will employ formative pretests to
assess the likely effectiveness of tobacco
communications with specific target
audiences. The information collected
will serve two major purposes. First, as
formative research it will provide the
critical knowledge needed about target
audiences. FDA must first understand
critical influences on people’s
decisionmaking process when choosing
to use, not use, or quit using tobacco
products. In addition to understanding
the decisionmaking processes of adults,
it is also critical to understand the
decisionmaking processes among
adolescents (ages 13 to 17), where
communications will aim to discourage
tobacco use before it starts. Knowledge
of these decisionmaking processes will
be applied by FDA to help design
effective communication strategies,
messages, and warning labels. Second,
as initial testing, it will allow FDA to
assess the potential effectiveness of
messages and materials in reaching and
successfully communicating with their
intended audiences. Pretesting messages
with a sample of the target audience
will allow FDA to refine messages while
they are still in the developmental stage.
By utilizing appropriate qualitative and
quantitative methodologies, FDA will be
able to: (1) Better understand
characteristics of the target audience-its
attitudes, beliefs, and behaviors-and use
E:\FR\FM\01MRN1.SGM
01MRN1
9226
Federal Register / Vol. 75, No. 39 / Monday, March 1, 2010 / Notices
these in the development of effective
risk communications; (2) more
efficiently and effectively design
messages and select formats that have
the greatest potential to influence the
target audience’s attitudes and behavior
in a favorable way; (3) determine the
best promotion and distribution
channels to reach the target audience
with appropriate messages; and (4)
expend limited program resource
dollars wisely and effectively.
Frequency of Response: On occasion.
Affected Public: Individuals or
households; Type of Respondents:
Members of the public, healthcare
professionals; organizational
representatives.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Type of Respondents
Adolescents 13–17, and Adults 18+
Annual Frequency
per Response
16,448
Total Annual
Responses
1
Hours per
Response
16,448
0.1739
Total
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–4098 Filed 2–26–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0066]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Human Tissue
Intended for Transplantation
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSKH9S0YB1PROD with NOTICES
2,860
2,860
1 There
ACTION:
Total Hours
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, 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 requirements
relating to FDA regulations for human
tissue intended for transplantation.
DATES: Submit written or electronic
comments on the collection of
information by April 30, 2010.
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.
VerDate Nov<24>2008
16:46 Feb 26, 2010
Jkt 220001
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:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792.
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,
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
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Human Tissue Intended for
Transplantation—21 CFR Part 1270
(OMB Control Number 0910–0302)—
Extension
Under section 361 of the Public
Health Service (PHS) Act (42 U.S.C.
264), FDA issued regulations under part
1270 (21 CFR part 1270) to prevent the
transmission of human
immunodeficiency virus (HIV), hepatitis
B, and hepatitis C through the use of
human tissue for transplantation. The
regulations provide for inspection by
FDA of persons and tissue
establishments engaged in the recovery,
screening, testing, processing, storage,
or distribution of human tissue. These
facilities are required to meet provisions
intended to ensure appropriate
screening and testing of human tissue
donors and to ensure that records are
kept documenting that the appropriate
screening and testing have been
completed.
Section 1270.31(a) through (d)
requires written procedures to be
prepared and followed for the following
steps: (1) All significant steps in the
infectious disease testing process under
§ 1270.21; (2) all significant steps for
obtaining, reviewing, and assessing the
relevant medical records of the donor as
prescribed in § 1270.21; (3) designating
and identifying quarantined tissue; and
(4) for prevention of infectious disease
contamination or cross-contamination
by tissue during processing. Section
1270.31(a) and (b) also requires
recording and justification of any
deviation from the written procedures.
Section 1270.33(a) requires records to be
maintained concurrently with the
performance of each significant step in
the performance of infectious disease
screening and testing of human tissue
E:\FR\FM\01MRN1.SGM
01MRN1
]]>Agencies
[Federal Register Volume 75, Number 39 (Monday, March 1, 2010)]
[Notices]
[Pages 9225-9226]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4098]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0084]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Pretesting of Tobacco 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 pretesting of tobacco communications.
DATES: Submit written or electronic comments on the collection of
information by April 30, 2010.
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: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-3794, e-mail:
Jonnalynn.capezzuto@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.
Pretesting of Tobacco Communications
In order to conduct educational and public information programs
relating to tobacco use, as authorized by section 903(d)(2)(D) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)) and to
develop stronger health warnings on tobacco packaging as authorized by
the Family Smoking Prevention and Tobacco Control Act (Tobacco Control
Act), it is beneficial for FDA to conduct research and studies relating
to the control and prevention of disease as authorized by section 301
of the Public Health Service Act (42 U.S.C 241(a)). In conducting such
research, FDA will employ formative pretests to assess the likely
effectiveness of tobacco communications with specific target audiences.
The information collected will serve two major purposes. First, as
formative research it will provide the critical knowledge needed about
target audiences. FDA must first understand critical influences on
people's decisionmaking process when choosing to use, not use, or quit
using tobacco products. In addition to understanding the decisionmaking
processes of adults, it is also critical to understand the
decisionmaking processes among adolescents (ages 13 to 17), where
communications will aim to discourage tobacco use before it starts.
Knowledge of these decisionmaking processes will be applied by FDA to
help design effective communication strategies, messages, and warning
labels. Second, as initial testing, it will allow FDA to assess the
potential effectiveness of messages and materials in reaching and
successfully communicating with their intended audiences. Pretesting
messages with a sample of the target audience will allow FDA to refine
messages while they are still in the developmental stage. By utilizing
appropriate qualitative and quantitative methodologies, FDA will be
able to: (1) Better understand characteristics of the target audience-
its attitudes, beliefs, and behaviors-and use
[[Page 9226]]
these in the development of effective risk communications; (2) more
efficiently and effectively design messages and select formats that
have the greatest potential to influence the target audience's
attitudes and behavior in a favorable way; (3) determine the best
promotion and distribution channels to reach the target audience with
appropriate messages; and (4) expend limited program resource dollars
wisely and effectively. Frequency of Response: On occasion. Affected
Public: Individuals or households; Type of Respondents: Members of the
public, healthcare professionals; organizational representatives.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Type of No. of Annual Frequency Total Annual Hours per
Respondents Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Adolescents 13- 16,448 1 16,448 0.1739 2,860
17, and
Adults 18+
----------------------------------------------------------------------------------------------------------------
Total 2,860
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: February 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-4098 Filed 2-26-10; 8:45 am]
BILLING CODE 4160-01-S
