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 omb@cdc.gov. 

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 

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 

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. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Individuals (male and female) aged 18 years and 

older.

Study Screener ............. 17,915 1 2/60 597 


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Federal Register / Vol. 79, No. 224 / Thursday, November 20, 2014 / Notices 69121 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

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. 

SUMMARY: 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_

submission@omb.eop.gov. All 

comments should be identified with the 

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

Wave 

Medical condition 

Chronic pain Hypertension 

Wave 1 ......................................................................................................................................... n=250 n=250 500 

Wave 2 ......................................................................................................................................... n=250 n=250 500 

Total ...................................................................................................................................... 500 500 1,000 


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