60 day FRN

65325

Federal Register / Vol. 78, No. 211 / Thursday, October 31, 2013 / Notices
Leroy A. Richardson
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2013–25799 Filed 10–30–13; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) 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. Written comments should
be received within 60 days of this
notice.
Proposed Project

Centers for Disease Control and
Prevention
[60Day-14–0879]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 or send
comments to LeRoy Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to [email protected].
Comments are invited 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)

Surveys of State, Tribal, Local, and
Territorial (STLT) Governmental
Agencies (OMB Control No. 0920–0879,
Exp. 3/31/2013)—Revision—Office of
the Director, Office for State, Tribal
Local and Territorial Support (OSTLTS),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
CDC’s mission is to create the
expertise, information, and tools that
people and communities need to protect
their health—through health promotion,
prevention of disease, injury and
disability, and preparedness for new
health threats. CDC seeks to accomplish
its mission by collaborating with
partners throughout the nation and the
world to: Monitor health, detect and
investigate health problems, conduct
research to enhance prevention, develop
and advocate sound public health
policies, implement prevention
strategies, promote healthy behaviors,
foster safe and healthful environments,
and provide leadership and training.
CDC is requesting a three-year
approval for a generic clearance to
collect information related to domestic
public health issues and services that

affect and/or involve state, tribal, local
and territorial (STLT) government
entities. The respondent universe is
comprised of STLT governmental staff
or delegates acting on behalf of a STLT
agency involved in the provision of
essential public health services in the
United States. Delegate is defined as a
governmental or non-governmental
agent (agency, function, office or
individual) acting for a principal or
submitted by another to represent or act
on their behalf. The STLT agency is
represented by a STLT entity or delegate
with a task to protect and/or improve
the public’s health. Information will be
used to assess situational awareness of
current public health emergencies; make
decisions that affect planning, response
and recovery activities of subsequent
emergencies; fill CDC gaps in
knowledge of programs and/or STLT
governments that will strengthen
surveillance, epidemiology, and
laboratory science; improve CDC’s
support and technical assistance to
states and communities. CDC will
conduct brief data collections, across a
range of public health topics related to
essential public health services.
CDC estimates up to 30 data
collections with STLT governmental
staff or delegates, and 10 data
collections with local/county/city
governmental staff or delegates will be
conducted on an annual basis. Ninetyfive percent of these data collections
will be web-based and five percent
telephone, in-person, and focus groups.
The total annualized burden of 54,000
hours is based on the following
estimates.

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Type of respondent

Form name

State, Territorial, or Tribal government staff or delegate.
Local/County/City government staff
or delegate.

Web, telephone, in-person, focus
group.
Web, telephone, in-person, focus
group.

Total ...........................................

...........................................................

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Number of
surveys per
respondent
type

Average
burden per
respondent
(in hours)

Total burden
hours
(annual)

800

30

1

24,000

3,000

10

1

30,000

........................

........................

........................

54,000

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65326

Federal Register / Vol. 78, No. 211 / Thursday, October 31, 2013 / Notices

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2013–25861 Filed 10–30–13; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1151]

Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Study of Direct-to-Consumer
Promotion Directed at Adolescents
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
research entitled, ‘‘Experimental Study
of Direct-to-Consumer (DTC) Promotion
Directed at Adolescents.’’ This study is
designed to examine how adolescents
interpret DTC advertising directed at
them.

SUMMARY:

Submit written or electronic
comments on the collection of
information by December 30, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to http://
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 Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the

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DATES:

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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.
Experimental Study of Direct-toConsumer (DTC) Promotion Directed at
Adolescents—(0910—NEW)
Regulatory Background
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
Section 1003(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.
Adolescents and DTC
Sponsors for several prescription drug
classes market their products directly to
vulnerable groups, including
adolescents. Such DTC marketing to
adolescents raises a variety of potential
concerns. Adolescents are a unique
audience for DTC drug marketing
because their cognitive abilities are
different than those of adults, and they
are usually dependent on adults for
health insurance coverage, health care

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provider access, and prescription drug
payment. Despite this uniqueness,
research regarding how adolescents use
risk and benefit information for healthrelated decisions is limited. If
considered at all in healthcare
communication research, age is
typically treated as simply another
segment of the audience (Ref. 1), and
researchers fail to consider how
information processing (how people
understand information) in response to
ad exposure might differ among
adolescents versus older viewers.
The FD&C Act requires
manufacturers, packers, and distributors
that advertise prescription drugs to
disclose certain information about a
product’s uses and risks to potential
consumers in all advertisements.
Consumers must consider tradeoffs with
regard to the product’s risks and
benefits in deciding whether to ask their
health care professionals about the
product. Presenting technically factual
information is important, but other
factors can also affect potential
consumers. Information processing
capacity, the relevance and vividness of
the information, and contextual factors
such as family dynamics likely affect
how adolescent consumers weigh the
potential risks and benefits of using a
product.
Despite the lack of previous research
specific to DTC drug marketing to
adolescents, existing theoretical and
empirical data make a strong case for
treating adolescence as a unique life
stage during which vulnerabilities that
can affect informed decision-making
must be taken into account. Well-known
theories of adolescent development
have long pointed to developmental
changes that occur during the
transitional period as an individual
moves from childhood to young
adulthood (Ref. 2). For instance, Erikson
(Refs. 3, 4) describes an often turbulent
psychosocial crisis that occurs as
adolescents strive to develop their
unique identify. Piaget (Refs. 5, 6) and
Kohlberg (Ref. 7) describe changes in
stages relative to cognitive processing
and reasoning that occur in this period,
as the adolescent becomes increasingly
capable of more abstract thinking.
Different cognitive, social and
emotional, and developmental processes
in the adolescent brain mature
simultaneously and at different rates,
affecting decision-making by age. All of
these factors can influence how
adolescents perceive and process
information as well as weigh risks and
benefits.
The need for understanding how
adolescents weigh risks and benefits is
particularly critical given the potential

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