Proposed Information Collection Activity; Comment Request, 76977-76978 [2011-31572]
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Federal Register / Vol. 76, No. 237 / Friday, December 9, 2011 / Notices
community-based programs that employ
multiple policy and environmental
change strategies.
Information to be collected from
participating CTG awardees includes
the interventions to be implemented;
expenditures for labor, personnel,
consultants, materials, travel, services,
and administration; in-kind
contributions; and partner organizations
and their expenditures. Information will
be collected electronically via a userfriendly, Web-based CTG Cost Study
Instrument (CTG–CSI). Respondents
will be a subset of 30 out of 35 CTG
awardees funded specifically for
implementation activities. CDC will
select awardees for participation in the
cost data collection based on a list of
priority interventions appropriate for
cost analysis.
Results of this data collection and
planned analyses, including
improvements in CDC’s analytic and
modeling tools, will be used to assist
CTG awardees, CDC, and HHS in
choosing intervention approaches for
particular populations that are both
beneficial to public health and costeffective.
OMB approval is requested for the
first three years of a five-year project
with first data collection beginning
approximately July 2012. CDC plans to
seek an extension of OMB approval to
support information collection through
the end of the five-year award period.
Information will be collected
electronically on a quarterly schedule.
The estimated burden per response is 11
hours and there are no costs to
respondents except their time to
participate in the survey.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
CTG Awardee ..................................................
CTG–CSI ...........................
Dated: December 2, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
OMB No.: 0970–0121.
Description: The LIHEAP leveraging
incentive program rewards LIHEAP
grantees that have leveraged non-federal
home energy resources for low-income
households. The LIHEAP leveraging
report is the application for leveraging
incentive funds that these LIHEAP
grantees submit to the Department of
Health and Human Services for each
fiscal year in which they leverage
countable resources. Participation in the
leveraging incentive program is
voluntary and is described at 45 CFR
96.87. The LIHEAP leveraging report
obtains information on the resources
leveraged by LIHEAP grantees each
fiscal year (as cash, discounts, waivers,
and in-kind); the benefits provided to
low-income households by these
[FR Doc. 2011–31622 Filed 12–8–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Low Income Home Energy
Assistance Program LIHEAP Leveraging
Report.
Number of
responses
per
respondent
30
Average
burden per
response
(in hrs)
4
11
Total burden
(in hrs)
1,320
resources (for example, as fuel and
payments for fuel, as home heating and
cooling equipment, and as
weatherization materials and
installation); and the fair market value
of these resources and benefits.
HHS needs this information in order
to carry out statutory requirements for
administering the LIHEAP leveraging
incentive program, to determine
countability and valuation of grantees
leveraged non-federal home energy
resources, and to determine grantees
shares of leveraging incentive funds.
HHS proposes to request a three-year
extension of OMB approval for the
currently approved LIHEAP leveraging
report information collection.
Respondents: State, Local or Tribal
Governments.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total
burden
hours
LIHEAP Leveraging Report .............................................................................
srobinson on DSK4SPTVN1PROD with NOTICES
Instrument
70
1
38
2,660
Estimated Total Annual Burden
Hours: 2,660.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
VerDate Mar<15>2010
18:35 Dec 08, 2011
Jkt 226001
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: ACF Reports Clearance
Officer. Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
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whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; (d) ways to
minimize the burden information to be
collected; and (e) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
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76978
Federal Register / Vol. 76, No. 237 / Friday, December 9, 2011 / Notices
to comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–31572 Filed 12–8–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0457]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental
Study of Comparative Direct-toConsumer Advertising
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 January 9,
2012.
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
title, ‘‘Experimental Study of
Comparative Direct-to-Consumer
Advertising.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, (301)
796–7651,
juanmanuel.vilela@fda.hhs.gov.
SUMMARY:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
srobinson on DSK4SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Experimental Study of Comparative
Direct-to-Consumer Advertising—(OMB
Control Number 0910—New)
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
VerDate Mar<15>2010
18:35 Dec 08, 2011
Jkt 226001
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
Section 903(d)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 393(d)(2)(C))
authorizes FDA to conduct research
relating to drugs and other FDA
regulated products in carrying out the
provisions of the FD&C Act.
Regulations specify that sponsors
cannot make comparative efficacy
claims in advertising for prescription
drugs without substantial evidence,
most often in the form of wellcontrolled clinical trials, to support
such claims (21 CFR 202.1(e)(6)(ii); 21
CFR 314.126). FDA has permitted some
comparisons based on labeled attributes,
such as indication, dosing, and
mechanism of action. When substantial
evidence does not yet exist, sponsors
have used communication techniques
that invite implicit comparisons, such
as making indirect comparisons, using
comparative visuals, and using vaguer
language. This study is designed to
apply the existing comparative
advertising literature to direct-toconsumer (DTC) advertising, where
little research has been conducted to
date.
Moreover, as part of the American
Recovery and Reinvestment Act of 2009
(Pub. L. 111–5), the Agency for
Healthcare Research and Quality is in
the process of securing a large
compendium of information on the
comparative effectiveness of medical
treatments in 14 priority medical
conditions, including arthritis, cancer,
dementia, depression, diabetes, and
substance abuse (Ref. 1). As part of this
process, they will fund a set of CHOICE
(Clinical and Health Outcomes Initiative
in Comparative Effectiveness) studies
designed to explore comparative
effectiveness. When this large project is
completed, FDA will have additional
information to consider when regulating
DTC advertising. It is possible that more
DTC advertising will be comparative in
nature. In preparation for this change,
FDA is embarking on the proposed
research to ensure that it has adequate
information to assess whether
comparative DTC ads provide truthful
and nonmisleading information to
consumers.
A. Comparative Advertising
Comparative advertisements typically
compare two or more named or
recognizably presented brands of the
same product category, although some
comparative advertisements implicitly
compare a product to other brands by
making superiority statements (e.g.,
‘‘Only Brand A can be cooked in five
minutes or less.’’). These ads are
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frequently used for commercial
products, such as electronics, food
products, and automobiles.
Marketing and advertising studies
have investigated the influence of
comparative ads, particularly in contrast
to noncomparative ads (Refs. 2 to 5).
Research specifically investigating the
effects of comparative advertising on
consumer attitudes—including attitudes
toward the ad, the brand, and product
use—has produced mixed results (Refs.
4 and 6). The research findings on the
superiority of comparative versus
noncomparative ads on purchase
intentions, however, have been more
conclusive. Relative to noncomparative
ads, comparative ads were shown to
result in greater purchase intentions
(Refs. 2 to 4 and7). Finally, other
evidence suggests that there may be
more potential for consumers to confuse
brands when viewing comparative
versus noncomparative ads. Brands
advertised in a comparative format were
shown to be more likely to be perceived
as similar to the leading brand than
brands advertised in a noncomparative
format (Refs. 8 to 10).
B. Comparative Prescription Drug
Advertisements
Despite extensive research on
comparative advertising of consumer
products and a limited number of
studies on how DTC ads could help
consumers compare drugs (Refs. 11 and
12), very little research has been
conducted on comparative prescription
drug advertisements (Ref. 13).
Consequently, it is unclear whether
these findings are applicable to
comparative drug ads or how such
claims influence consumers’ perceived
efficacy of advertised drugs.
Currently, most DTC ad comparisons
focus on drug attributes, such as
differences in dosing or administration
method (see 21 CFR 314.126). Because
few head-to-head clinical trials have
been conducted, very few DTC ads
include efficacy-based comparisons
(Ref. 13). The present study aims to
investigate how consumers interpret
and react to DTC comparative drug ads.
Specifically, the study will explore two
types of drug comparisons in DTC ads:
(1) Drug efficacy comparisons and (2)
other evidence-based comparisons, such
as dosing, mechanism of action, and
indication. The study findings will
inform FDA of relevant consumer issues
relating to comparative DTC advertising.
C. Design Overview
The proposed research will occur in
two concurrent phases. The goal of
Phase I is to: (1) Explore how consumers
understand and interpret print and
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]]>Agencies
[Federal Register Volume 76, Number 237 (Friday, December 9, 2011)]
[Notices]
[Pages 76977-76978]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-31572]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Low Income Home Energy Assistance Program LIHEAP Leveraging
Report.
OMB No.: 0970-0121.
Description: The LIHEAP leveraging incentive program rewards LIHEAP
grantees that have leveraged non-federal home energy resources for low-
income households. The LIHEAP leveraging report is the application for
leveraging incentive funds that these LIHEAP grantees submit to the
Department of Health and Human Services for each fiscal year in which
they leverage countable resources. Participation in the leveraging
incentive program is voluntary and is described at 45 CFR 96.87. The
LIHEAP leveraging report obtains information on the resources leveraged
by LIHEAP grantees each fiscal year (as cash, discounts, waivers, and
in-kind); the benefits provided to low-income households by these
resources (for example, as fuel and payments for fuel, as home heating
and cooling equipment, and as weatherization materials and
installation); and the fair market value of these resources and
benefits.
HHS needs this information in order to carry out statutory
requirements for administering the LIHEAP leveraging incentive program,
to determine countability and valuation of grantees leveraged non-
federal home energy resources, and to determine grantees shares of
leveraging incentive funds. HHS proposes to request a three-year
extension of OMB approval for the currently approved LIHEAP leveraging
report information collection.
Respondents: State, Local or Tribal Governments.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
LIHEAP Leveraging Report.................... 70 1 38 2,660
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 2,660.
In compliance with the requirements of Section 506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Planning, Research and Evaluation, 370 L'Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
The Department specifically requests comments on: (a) Whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; (d) ways to minimize the burden information to be
collected; and (e) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given
[[Page 76978]]
to comments and suggestions submitted within 60 days of this
publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011-31572 Filed 12-8-11; 8:45 am]
BILLING CODE 4184-01-P
