Federal Register / Vol. 77, No. 40 / Wednesday, February 29, 2012 / Notices 12307 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0176] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Experimental 

Study: Examination of Corrective 

Direct-to-Consumer Television 

Advertising 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: 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: 

Examination of Corrective Direct-toConsumer (DTC) Television 

Advertising.’’ The proposed research 

will examine how corrective advertising 

may impact consumer misperceptions 

about prescription drug product safety 

and efficacy. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 30, 2012. 

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: 

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. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

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: Examination of 

Corrective DTC Television Advertising 

I. Regulatory Background 

Section 1701(a)(4) of the Public 

Health Service Act (42 CFR 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. 

II. Description 

FDA regulations require prescription 

drug advertisements to contain accurate 

information about the benefits and risks 

of the drug advertised. When this is not 

the case, corrective advertising is 

designed to dissipate or correct 

erroneous beliefs resulting from a false 

claim (Refs. 1 and 2). Corrective 

advertising emerged in public debate in 

the United States in the 1970s as a 

hypothetical remedy for deceptive 

advertising, having first been proposed 

by Georgetown University law students 

in 1969 as a way of dispelling the effects 

of deceptive advertising (Ref. 3). 

Corrective advertising is one remedy 

FDA may request in response to false or 

misleading prescription drug 

promotion. In 2009, for example, Bayer 

HealthCare Pharmaceuticals produced 

and aired corrective DTC advertising for 

Yaz, a birth control pill, following a 

warning from FDA regarding misleading 

claims (Ref. 4). Despite these 

developments, researchers and 

policymakers currently lack exhaustive 

empirical literature regarding the 

various impacts of corrective DTC 

advertisements on prescription drug 

consumers. The current project will 

examine how variations in corrective 

advertising may impact consumers’ 

misleading product beliefs. 

III. Design and Method Overview 

The study will involve three 

independent variables: Message 

exposure, similarity of original and 

corrective ads, and length of time 

between exposure to original and 

corrective ad in a medium prevalence 

medical condition (defined as between 

5 percent and 10 percent of U.S. adult 

population). These variables will be 

examined in two phases. Participants 

will be recruited from an online Internet 

panel and will answer the survey 

questions online. 

Phase 1 will vary the exposure to the 

messages (original ad alone versus 

original + corrective versus corrective 

ad alone). The goal of Phase 1 is to 

examine how exposure to a combination 

of original and corrective DTC 

advertisements affects message recall, 

message comprehension, perceived drug 

efficacy, perceived drug risk, and 

intentions to ask about or use the drug. 

Specifically, we will compare 

consumers who see both the original 

and corrective ad with those who see 

only the original ad, only the corrective 

ad, and neither ad. 

TABLE 1—DESIGN OF PHASE 1: ORIGINAL EXPOSURE BY CORRECTIVE EXPOSURE

Exposure to 

Original ad 

Exposure to Corrective ad 

Yes No 

Yes ................ .....................

No .................. ..................... (filler task 

only) 

Phase 2 will examine the similarity of 

the corrective ad’s theme and visual 

elements to those of the original ad 

(same ad elements versus some similar 

ad elements versus different ad 

elements) and the exposure delay (time) 

between viewing the original ad and the 

corrective ad (no delay versus 1 week 

delay versus 1 month delay). The 

purpose of Phase 2 is to examine 

whether a corrective advertisement’s 


tkelley on DSK3SPTVN1PROD with NOTICES
12308 Federal Register / Vol. 77, No. 40 / Wednesday, February 29, 2012 / Notices 

ability to correct misinformation is 

related to (a) corrective ad similarity to 

the original ad and (b) time delay 

between original ad and corrective ad 

exposure. 

We will vary these two characteristics 

to create a study with a 4x3 

experimental design (see table 2). 

TABLE 2—DESIGN OF PHASE 2: AD SIMILARITY BY EXPOSURE DELAY

Corrective ad similarity 

Exposure delay 

None 1 Week 1 Month 

Same ad elements ......................................................................................................................................................

Some similar elements ................................................................................................................................................

Different ad elements ..................................................................................................................................................

Control (Do not see corrective) ...................................................................................................................................

Prior to conducting the main study, 

we will pretest the stimuli, 

questionnaires, and data collection 

process. The first set of pretests will 

focus on the stimuli, and its purpose 

will be to (a) ensure the stimuli display 

properly, (b) ensure participants 

perceive the stimuli as realistic, and (c) 

ensure participants notice the original 

and corrective messages in the ads. The 

second pretest will focus on the 

questionnaires and data collection 

process. Its purpose will be to (a) ensure 

that survey questions solicit responses 

that meet the study’s analytic goals and 

(b) ensure data are captured and stored 

accurately for each question. 

FDA estimates the burden of this 

collection of information as follows: 30 

minutes in the pretests and each phase 

of the study, for a burden of 3,092 

hours. This will be a one time (rather 

than annual) collection of information. 

The questionnaire is available upon 

request. 

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity No. of respondents 

No. of responses per 

respondent 

Total annual 

responses Average burden per response Total hours 

Pretests ............................................. 1,250 1 1,250 0.5 (30 minutes) ............................... 625 

Phase 1 Screener ............................. 3,228 1 3,228 0.033 (2 minutes) ............................. 108 

Phase 1 ............................................. 1,000 1 1,000 0.5 (30 minutes) ............................... 500 

Phase 2 Screener ............................. 10,768 1 10,768 0.033 (2 minutes) ............................. 359 

Phase 2 ............................................. 3,000 1 3,000 0.5 (30 minutes) ............................... 1,500 

Total ........................................... 19,246 ........................ ........................ ........................................................... 3,092 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

IV. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

1. Darke, P.R., L. Ashworth, and R.J.B. 

Ritchie, ‘‘Damage From Corrective 

Advertising: Causes and Cures,’’ Journal of 

Marketing, vol. 72, pp. 81–97, 2008. 

2. Mazis, M.B. and J.E. Adkinson, ‘‘An 

Experimental Evaluation of a Proposed 

Corrective Advertising Remedy,’’ Journal of 

Marketing Research, vol. 13, pp. 178–183, 

1976. 

3. Mazis, M.B., D.L. McNeill, and K.L. 

Bernhardt, ‘‘Day-After Recall of Listerine 

Corrective Commercials,’’ Journal of Public 

Policy & Marketing, vol. 2, pp. 29–37, 1983. 

4. Singer, N., A Birth Control Pill That 

Promised Too Much, New York Times, 

February 11, 2009, p. B1. 

Dated: February 23, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4777 Filed 2–28–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0797] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; State Enforcement 

Notifications 

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 March 30, 

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 0910–0275. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, II, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

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. 

State Enforcement Notifications—21 

CFR 100.2(d) (OMB Control Number 

0910–0275)—Extension 

Section 310(b) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 337(b)) authorizes States to 


tkelley on DSK3SPTVN1PROD with NOTICES