60 day FRN

69120

Federal Register / Vol. 79, No. 224 / Thursday, November 20, 2014 / Notices

OS specifically requests comments on
(1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Darius Taylor,
Information Collection Clearance Officer.
[FR Doc. 2014–27473 Filed 11–19–14; 8:45 am]
BILLING CODE 4168–11–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–15–0920]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
The Centers for Disease Control and
Prevention (CDC), as part of its
continuing effort to reduce public
burden, invites the general public and
other Federal agencies to take this
opportunity to comment on proposed
and/or continuing information
collections, as required by the
Paperwork Reduction Act of 1995. To
request more information on the below
proposed project or to obtain a copy of
the information collection plan and
instruments, call 404–639–7570 or send
comments to Leroy A. Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to [email protected].
Comments submitted in response to
this notice will be summarized and/or
included in the request for Office of
Management and Budget (OMB)
approval. 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) ways to enhance the

subgroups or communities at greatest
risk of infection. The current study
addresses the need to assess the
effectiveness of these social marketing
messages aimed at increasing HIV
awareness and delivering HIV
prevention and testing messages among
at-risk populations.
This extension of an ongoing study
will evaluate the Act Against AIDS
(AAA) social marketing campaign aimed
at increasing HIV/AIDS awareness,
increasing prevention behaviors, and
improving HIV testing rates among
consumers. A total of 12,000
respondents were originally approved
for this generic ICR (0920–0920) and
since the original approval date, 1,250
respondents have participated in the
surveys under the following mini ICRs:
0920–13AHP; 0920–13YR and 0920–
13DD. The information collected from
each of the data collections were used
to evaluate specific AAA campaign
phases. We are requesting additional
time to continue to survey other AAA
target audiences and campaign phases
and measuring exposure to each phase
of the campaign and interventions
implemented under AAA. Through this
extension, we plan to reach the
remaining approved 10,750
respondents. In order to obtain the
remaining respondents, we anticipate
screening approximately 17,915
individuals.
Depending on the target audience for
the campaign phase, the study screener
will vary. The study screener may
address one or more of the following
items: race/ethnicity, sexual behavior,
and sexual orientation. Each survey will
have a core set of items asked in all
rounds, as well as a module of questions
relating to specific AAA activities and
communication initiatives.
Survey respondents will be selected
from a combination of sources,
including a national opt-in email list
sample and respondent lists generated
by partnership organizations (e.g., the
National Urban League, the National
Medical Association). A total of 10,750
participants will self-administer the
survey at home on personal computers
over a 3-year period.
There is no cost to the respondents
other than their time.

quality, utility, and clarity of the
information to be collected; (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; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. Written comments should
be received within 60 days of this
notice.
Proposed Project
Data Collection Through Web Based
Surveys for Evaluating Act Against
AIDS Social Marketing Campaign
Phases Targeting Consumers (Generic
ICR, OMB# 0920–0920, Expires 2/28/
2015)—Extension—National Center for
HIV/AIDS, Viral Hepatitis, STD and TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
In response to the continued HIV
epidemic in our country, CDC has
launched Act Against AIDS, a 5-year,
multifaceted communication campaign
to reduce HIV incidence in the United
States. CDC plans to release the
campaign in phases, with some of the
phases running concurrently. Each
phase of the campaign will use mass
media and direct-to-consumer channels
to deliver HIV prevention and testing
messages. Some components of the
campaign will be designed to provide
basic education and increase awareness
of HIV/AIDS among the general public,
and others will be targeted to specific

rmajette on DSK2VPTVN1PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Respondents

Form name

Individuals (male and female) aged 18 years and
older.

Study Screener .............

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Number of
responses per
respondent

17,915

E:\FR\FM\20NON1.SGM

1

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Average
burden per
response
(in hours)
2/60

Total burden
(in hours)
597

69121

Federal Register / Vol. 79, No. 224 / Thursday, November 20, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
burden per
response
(in hours)

Number of
responses per
respondent

Number of
respondents

Total burden
(in hours)

Respondents

Form name

Individuals (male and female) aged 18 years and
older.

Survey Module .............

3,583

1

30/60

1,792

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

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

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

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

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

2,389

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. 2014–27467 Filed 11–19–14; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0373]

Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Risk and Benefit
Perception Scale Development
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 December
22, 2014.
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_
[email protected]. All
comments should be identified with the
SUMMARY:

OMB control number 0910-New and
title, ‘‘Risk and Benefit Perception Scale
Development.’’ Also include the FDA
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Risk and Benefit Perception Scale
Development (OMB Control Number
0910-New)
Section 1701(a)(4) of the Public
Health Service Act (PHS 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(b)(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.
FDA requires that prescription drug
advertisements be balanced in their
presentation of risk and benefit
information. Patients receive
information on drugs not only from
their doctors and pharmacies, through
patient labeling and FDA-mandated
Medication Guides, but also online, on
social networks and via direct-toconsumer (DTC) television and print
advertising. Moreover, research suggests
that consumers struggle with the
concepts of risk and efficacy (Ref. 1) and
often overestimate drug efficacy (Ref. 2).

As a result, it is important for FDA to
understand and accurately measure how
consumers are making sense of this
information and how it impacts
decisions related to prescription drugs.
FDA’s Office of Prescription Drug
Promotion (OPDP) has an active
research program that investigates how
DTC advertising influences consumer
knowledge, perceptions, and behavior.
As OPDP’s research program has
matured, the way in which we measure
risk and benefit perception has evolved
over time. This has resulted in
perception measures that, while
internally valid, tend to vary by study.
Consequently, FDA needs a pool of
reliable and valid measurement items
for assessing consumers’ drug risk and
benefit perceptions—as well as other
elements of prescription drug decision
making—consistently across studies.
The purpose of this project is to create
that measurement pool, thus increasing
the rigor and efficiency of FDA’s
research.
I. Design Overview
We will conduct pretesting prior to
main data collection to assess the
psychometric properties and identify
any measurement challenges (e.g.,
misinterpretation, lack of variance) with
candidate measurement items. We also
will use the pretesting to examine
factors that may affect future study
results and analyses (e.g., response scale
midpoints, moderating variables). We
will conduct two sequential pretest
waves (n=500 per wave; n=1,000 total)
with the following target populations:
(1) Individuals diagnosed with chronic
pain and (2) individuals diagnosed with
hypertension.

EXHIBIT 1—PRETEST STUDY DESIGN
rmajette on DSK2VPTVN1PROD with NOTICES

Medical condition
Wave
Chronic pain

Hypertension

Wave 1 .........................................................................................................................................
Wave 2 .........................................................................................................................................

n=250
n=250

n=250
n=250

500
500

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

500

500

1,000

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