1636 Federal Register / Vol. 80, No. 8 / Tuesday, January 13, 2015 / Notices 

is unavailable, you may contact Mr. 

Jeffrey J. Gee, Acting Chief, 

Investigations and Hearings Division, by 

telephone at (202) 418–1420 and by 

email at Jeffrey.Gee@fcc.gov. 

Federal Communications Commission. 

Jeffrey J. Gee, 

Acting Chief, Investigations and Hearings 

Division, Enforcement Bureau. 

[FR Doc. 2015–00355 Filed 1–12–15; 8:45 am] 

BILLING CODE 6712–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–15–14AOO] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) has submitted the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995. The notice for 

the proposed information collection is 

published to obtain comments from the 

public and affected agencies. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information are encouraged. Your 

comments should address any of the 

following: (a) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the functions of the agency, including 

whether the information will have 

practical utility; (b) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; (d) Minimize the burden of 

the collection of information on those 

who are to respond, including through 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and (e) Assess information 

collection costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570 or 

send an email to omb@cdc.gov. Written 

comments and/or suggestions regarding 

the items contained in this notice 

should be directed to the Attention: 

CDC Desk Officer, Office of Management 

and Budget, Washington, DC 20503 or 

by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Monitoring and Reporting System for 

the Division of Community Health’s 

Cooperative Agreement Programs— 

New—National Center for Chronic 

Disease Prevention and Health 

Promotion (NCCDPHP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

In September 2014, the Division of 

Community Health (DCH), Centers for 

Disease Control and Prevention (CDC), 

announced 93 awards under three new 

cooperative agreement programs 

authorized by the Public Health Service 

Act and the Prevention and Public 

Health Fund of the Affordable Care Act 

(FOA DP14–1417, FOA DP14–1418, and 

FOA DP14–1419PPHF14). The new 

programs are designed to address 

chronic diseases and risk factors for 

chronic diseases, including physical 

inactivity, poor diet, obesity, and 

tobacco use. The programs will provide 

support for implementation of broad, 

evidence- and practice-based policy and 

environmental improvements in a mix 

of 93 large and small cities, urban rural 

areas, tribes, multi-sectorial community 

coalitions, and racial and ethnic 

communities experiencing chronic 

disease disparities. Awardees include a 

combination of 41 state, local, and tribal 

governmental agencies and 52 nongovernmental (private sector) entities. 

CDC is seeking OMB approval to 

collect information from the new DCH 

awardees utilizing an electronic Policy, 

Environment, Programmatic, and 

Infrastructure Database (PEPID) 

designed to enable the accurate, reliable, 

uniform and timely submission to CDC 

of each awardee’s work plan and 

progress reports. Monitoring allows CDC 

to determine whether an awardee is 

meeting performance goals, to make 

adjustments in the type and level of 

technical assistance provided to them, 

and to provide oversight of the use of 

federal funds. The burden per response 

for routine, semi-annual reporting 

through PEPID is three hours. The 

burden estimate also includes a onetime allocation of 15 hours for initial 

population of the PEPID system, which 

is annualized over the period of the 

information collection request. 

CDC is also requesting OMB approval 

to conduct targeted, special purpose 

information collections on an as-needed 

basis. Due to substantial interest in the 

new cooperative agreement programs, 

CDC estimates that each DCH awardee 

could be asked to participate in one 

special purpose information collection 

per year to supplement routine progress 

reporting. Each special purpose 

information collection request will be 

submitted to OMB for approval through 

the Change Request mechanism, and 

will include the data collection 

instrument(s) and a description of 

purpose and methods. The ability to 

conduct special purpose data 

collections will enable CDC to 

effectively manage programmatic 

activities and respond to inquiries. The 

estimated burden per response for each 

special data request is six hours. 

OMB approval is requested for three 

years. Participation is required for 

cooperative agreement awardees. There 

are no costs to respondents other than 

their time. The total estimated 

annualized burden hours are 1,596. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

DCH Program Awardees (state, local and tribal government entities).DCH PEPID: Initial population ......... 14 1 15 

DCH PEPID: Semi-annual reporting 41 2 3 

Special PEPID Request ................... 41 1 6 

DCH Program Awardees (private sector entities) ......... DCH PEPID: Initial population ......... 18 1 15 

DCH PEPID: Semi-annual reporting 52 2 3 

Special Data Request ...................... 52 1 6 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 8 / Tuesday, January 13, 2015 / Notices 1637 

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. 2015–00268 Filed 1–12–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0168] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Disclosure 

Regarding Additional Risks in Directto-Consumer Prescription Drug 

Television Advertisements 

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: Submit either electronic or 

written comments on the collection of 

information by February 12, 2015. 

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 ‘‘Disclosure Regarding Additional 

Risks in Direct-to-Consumer (DTC) 

Prescription Drug Television (TV) 

Advertisements (Ads).’’ 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. 

Disclosure Regarding Additional Risks 

in Direct-to-Consumer Prescription 

Drug Television 

Advertisements—(OMB Control 

Number 0910–NEW) 

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(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. 

Prescription drug advertising 

regulations (21 CFR 202.1) require that 

broadcast (TV or radio) advertisements 

present the product’s major risks in 

either audio or audio and visual parts of 

the advertisement; this is often called 

the ‘‘major statement.’’ There is concern 

that as currently implemented in DTC 

ads, the major statement is often too 

long, which may result in reduced 

consumer comprehension, minimization 

of important risk information and, 

potentially, therapeutic non-compliance 

due to fear of side effects. At the same 

time, there is concern that DTC TV ads 

do not include adequate risk 

information or leave out important 

information. These are conflicting 

viewpoints. A possible resolution is to 

limit the risks in the major statement to 

those that are serious and actionable, 

and include a disclosure to alert 

consumers that there are other product 

risks not included in the ad. For 

example, the disclosure could be, ‘‘This 

is not a full list of risks and side effects. 

Talk to your doctor and read the patient 

labeling for more information.’’ The 

Office of Prescription Drug Promotion 

plans to investigate the effectiveness of 

this ‘‘limited risks plus disclosure’’ 

strategy through empirical research. 

Our primary hypothesis is that, 

relative to inclusion of the full major 

statement, providing limited risk 

information along with the disclosure 

about additional risks will promote 

improved consumer perception and 

understanding of serious and actionable 

drug risks. We will also investigate 

other questions such as whether overall 

drug risk and benefit perceptions are 

affected by these changes. To examine 

differences between experimental 

conditions, we will conduct inferential 

statistical tests such as analysis of 

variance. With the sample size 

described further in this document, we 

will have sufficient power to detect 

small-to-medium sized effects in the 

main study. 

Participants will be consumers who 

self-identify as having been diagnosed 

with one of three possible medical 

conditions: Depression, high 

cholesterol, or insomnia. All 

participants will be 18 years of age or 

older. We will exclude individuals who 

work in healthcare or marketing settings 

because their knowledge and 

experiences may not reflect those of the 

average consumer. Recruitment and 

administration of the study will take 

place over the Internet. Participation is 

estimated to take approximately 30 

minutes. 

Within medical condition, 

participants will be randomly assigned 

to view one of four possible versions of 

a DTC ad, as depicted in table 1. One 

version will present the full major 

statement without the disclosure 

regarding additional risks (Conditions C, 

G, and K). This version will implement 

existing ads in the marketplace. Stimuli 

variations for the other three versions 

will be achieved by replacing the audio 

track of the original ad with the revised 

risk and disclosure statements described 

previously. Thus, a second version of 

the ad will include the full major 

statement plus the disclosure about 

additional risks (Conditions A, E, and I). 

A third version will include an 

abbreviated statement of risks without 

the disclosure about additional risks 

(Conditions D, H, and L). The fourth 

version will include an abbreviated 

statement of risks as well as the 

disclosure about additional risks 

(Conditions B, F, and J). 

After viewing the ad, participants will 

respond to questions about information 

in the ad. Measures are designed to 

assess perception and understanding of 

product risks and benefits; perception 

and understanding of the disclosure 

about additional risks; perceptions of 

product quality; intention to seek more 

information about the product; and 

perceptions of trust/skepticism 

regarding product claims and the 

sponsor. The questionnaire is available 

upon request. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES