29490 Federal Register / Vol. 74, No. 118 / Monday, June 22, 2009 / Notices 

1For prescription drugs and biologics, section 

502 of the act requires advertisements to contain 

‘‘information in brief summary relating to side 

effects, contraindications, and effectiveness’’ (21 

U.S.C. 352(n)). 

2See Swartz, L., S. Woloshin, W. Black, et al., The 

Role of Numeracy in Understanding the Benefit of 

total estimated annualized burden hours 

are 10,832. 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of respondent Form name No. of 

respondents 

No. of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Hospital Chief Executive Officer ..................... Hospital Induction (NHAMCS–101) ................ 482 1 1 

Ancillary Service Executive ............................ Freestanding ASC Induction (NHAMCS– 

101FS).

200 1 1.5 

Ancillary Service Executive ............................ Ambulatory Unit Induction (NHAMCS–101U) 1,779 1 1 

Physician/Registered Nurse/Medical Record 

Clerk.

ED Patient Record form NHAMCS–100 (ED) 225 100 7/60 

Physician/Registered Nurse/Medical Record 

Clerk.

OPD Patient Record form NHAMCS–100 

(OPD).

128 200 6/60 

Physician/Registered Nurse/Medical Record 

Clerk.

ASC Patient Record Form NHAMCS–100 

(ASC).

208 100 6/60 

Medical Record Clerk ..................................... Pulling and re-filing Patient Records (ED, 

OPD, and ASC).

425 133 1/60 

Physician/Physician Assistant/Nurse Practitioner/Nurse Midwife.Cervical Cancer Screening Supplement 

(CCSS) (NHAMCS–906).

255 1 15/60 

Dated: June 15, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Office of 

the Chief Science Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E9–14553 Filed 6–19–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0263] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Experimental 

Study of Presentation of Quantitative 

Effectiveness Information to 

Consumers in Direct-to-Consumer 

Television and Print Advertisements 

for Prescription Drugs 

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 

the Experimental Study of Presentation 

of Quantitative Effectiveness 

Information to Consumers in Direct-toConsumer (DTC) Television and Print 

Advertisements for Prescription Drugs. 

This study is designed to communicate 

quantitative information about product 

benefits in DTC print and television ads. 

DATES: Submit written or electronic 

comments on the collection of 

information by [August 21, 2009 

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: Liz 

Berbakos, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3792. 

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 of Presentation of 

Quantitative Effectiveness Information 

to Consumers in Direct-to-Consumer 

(DTC) Television and Print 

Advertisements for Prescription 

Drugs—New 

The Federal Food, Drug, and Cosmetic 

Act (the act) requires that 

manufacturers, packers, and distributors 

(sponsors) who advertise prescription 

human and animal drugs, including 

biological products for humans, disclose 

in advertisements certain information 

about the advertised product’s uses and 

risks.1 By its nature, the presentation of 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 74, No. 118 / Monday, June 22, 2009 / Notices 29491 

Screening Mammography, Annals of Internal 

Medicine, 127(11), 966–72, 1997. 3Woloshin, S. and L. Schwartz, Direct to 

Consumer Advertisements for Prescription Drugs: 

What Are Americans Being Told, Lancet, 358, 

1141–46, 2001. 4Frosch, D.L., P.M. Krueger, R.C. Hornik, et al., 

Creating Demand for Prescription Drugs: A Content 

Analysis of Television Direct-to-Consumer 

Advertising, Annals of Family Medicine, 5(1), 6–13, 

2007. 

5Schwartz, L.M., S. Woloshin, H.G. Welch, The 

Drug Facts Box: Providing Consumers With Simple 

Tabular Data on Drug Benefit and Harm, Medical 

Decision Making, 27, 655–692, 2007; Schwartz, 

L.M., S. Woloshin, H.G. Welch, Communicating 

Drug Benefits and Harms With a Drug Facts Box: 

Two Randomized Trials, Annals of Internal 

Medicine, 150, 516–527, 2009; Woloshin, S., L.M. 

Schwartz, H.G. Welch, The Value of Benefit Data in 

Direct-to-Consumer Drug Ads, Health Affairs, Suppl 

Web Exclusives, W4–234–245, 2004. 

6Beyth-Marom, R., How Probable is Probable? A 

Numerical Translation of Verbal Probability 

Expressions, Journal of Forecasting, 1, 257–269, 

1982; Bowman, M.L., The Perfidity of Percentiles, 

Archives of Clinical Neuropsychology, 17, 295–303, 

2002; Cohen, D.J., J.M. Ferrell, N. Johnson, What 

Very Small Numbers Mean, Journal of Experimental 

Psychology: General, 131, 424–442, 2002. 

7Fagerlin, A., C. Wang, P.A. Ubel, Reducing the 

Influence of Anecdotal Reasoning on People’s 

Health Care Decisions: Is a Picture Worth a 

Thousand Statistics? Medical Decision Making, 25, 

398–405, 2005; Lipkus, I., Numeric, Verbal, and 

Visual Formats of Conveying Health Risks: 

Suggested Best Practices and Future 

Recommendations, Medical Decision Making, 27, 

697–713, 2007. 

this information is likely to evoke active 

trade-offs by consumers, i.e., 

comparisons with the perceived risks of 

not taking treatment, and comparisons 

with the perceived benefits of taking a 

treatment.2 FDA has an interest in 

fostering safe and proper use of 

prescription drugs, an activity that 

engages both risks and benefits. 

Therefore, an examination of ways to 

improve consumers’ understanding of 

this information is central to this 

regulatory task. 

Under the act, FDA engages in a 

variety of communication activities to 

ensure that patients and health care 

providers have the information they 

need to make informed decisions about 

treatment options, including the use of 

prescription drugs. FDA regulations (21 

CFR 201.57) describe the content of 

required product labeling, and FDA 

reviewers ensure that labeling contains 

accurate and complete information 

about the known risks and benefits of 

each drug. 

FDA regulations require that 

prescription drug advertisements that 

make (promotional) claims about a 

product also include risk information in 

a ‘‘balanced’’ manner (21 CFR 

202.1(e)(5)(ii)), both in terms of the 

content and presentation of the 

information. This balance applies to 

both the front, display page of an 

advertisement, as well as including the 

brief summary page. However, beyond 

the ‘‘balance’’ requirement there is 

limited guidance and research to direct 

or encourage sponsors to present benefit 

claims that are informative, specific, 

and reflect clinical effectiveness data. 

Research and guidance to sponsors on 

how to present benefit and efficacy 

information in prescription drug 

advertisements is limited. For example, 

‘‘benefit claims,’’ broadly defined, 

appearing in advertisements are often 

presented in general language that does 

not inform patients of the likelihood of 

efficacy and are often simply variants of 

an ‘‘intended use’’ statement. One 

content analysis of DTC advertising by 

Woloshin and Schwartz (2001)3 found 

that information about product benefits 

and risks is often presented in an 

unbalanced fashion. The researchers 

classified the ‘‘promotional techniques’’ 

used in the advertisements. Emotional 

appeals were observed in 67 percent of 

the ads while vague and qualitative 

benefit terminology was found in 87 

percent of the ads. Only 9 percent 

contained data. However, for risk 

information, half the advertisements 

used data to describe side-effects, 

typically with lists of side-effects that 

generally occurred infrequently. 

Similarly, a content analysis by Frosch 

et al. (2007)4 found that only a small 

proportion of product-claim ads gave 

specific information about the 

population prevalence of the medical 

condition being advertised. The authors 

criticize DTC for presenting ‘‘best-case 

scenarios that can distort and inflate 

consumers’ expectations about what 

prescription drugs can accomplish’’ 

(Froch et al., 2007, p. 12) without 

disclosing how many consumers are 

likely to experience that benefit. 

Some research has proposed that 

providing quantitative information 

about product efficacy enables 

consumers to make better choices about 

potential therapy. One possible format 

(termed the ‘‘drug facts’’ box by its 

creators) for this information has 

recently received attention.5 In these 

studies, the drug facts box format 

contained information about the 

product’s efficacy and safety in terms of 

rate (how many people in the clinical 

trial experienced a benefit or side effect 

compared to placebo). As expected, this 

study showed that consumers who were 

provided efficacy information used it. 

Participants receiving efficacy 

information (without other potentially 

valuable information about the drug) 

were more likely to correctly choose the 

product with the higher efficacy than 

consumers who saw the brief summary 

that did not contain this information. 

Although these results are intriguing, 

additional research is necessary to 

uncover important information about 

how consumers understand 

effectiveness information about 

prescription drug products from DTC 

advertisements. For example, the 

research to date does not address 

whether simply adding efficacy rate 

information and qualitative summations 

to a consumer-friendly brief summary 

would enable consumers to find and 

report the correct answer, or if the 

presentation of information in a chart 

format itself increases comprehension. 

Further, these data cannot address the 

best way in which to convey numerical 

information; percents were used but 

another format, such as frequencies, 

may be more effective at communicating 

quantitative information. Previous 

research shows that individuals have 

great difficulty processing numerical 

concepts (e.g., Beyth-Marom, 1982; 

Bowman, 2002; Cohen, Ferrell, and 

Johnson, 2002).6 A few studies have 

attempted to determine what different 

formats make these concepts least 

troublesome (e.g., Fagerlin, Wang, and 

Ubel, 2005; Lipkus, 2007),7 however, 

most research into the communication 

of numerical concepts concentrates on 

risk information. We are not aware of 

research looking into the integration of 

quantitative information about 

effectiveness or benefits into the body of 

the advertisement itself. The addition of 

this information may help consumers 

make better healthcare decisions, 

provided they can understand it. 

It is also not known if ways of 

communicating product efficacy work 

equally well across print and television 

DTC media. To our knowledge, research 

on presenting quantitative information 

in risk communication has been 

conducted exclusively with static 

modalities. The ideal format for 

presenting quantitative information may 

vary as a function of presentation. The 

amount of mental processing capacity 

each individual can devote to 

understanding a message varies 

depending on how long individuals 

have to look at the material and whether 

the material is self-paced or presented at 

an uncontrollable speed. As a result, 

some forms of quantitative information 

may lend themselves to print, rather 

than broadcast. This particular 

understanding is crucial to the riskbenefit tradeoff that patients must make 

with the consultation of a health care 

professional in order to achieve the best 

health outcomes. 

The proposed study will examine: (1) 

Various ways of communicating 


pwalker on PROD1PC71 with NOTICES
29492 Federal Register / Vol. 74, No. 118 / Monday, June 22, 2009 / Notices 

quantitative efficacy in DTC print ads 

and (2) whether the findings translate to 

DTC television ads. 

Design Overview: This study will be 

conducted in two concurrent parts; one 

examining quantitative information in 

DTC print advertisements and the other 

examining such information in DTC 

television advertisements. Three factors 

will be examined: Drug efficacy, visual 

format, and type of statistic. Drug 

efficacy (low versus high) is defined by 

a quantifiable, objective metric that can 

be conveyed in graphical 

representations of the drug versus the 

comparator reference drug (in this case, 

placebo). ‘‘High’’ efficacy is noticeably 

better than the placebo, whereas ‘‘low’’ 

efficacy is minimally better than the 

placebo. Visual format is defined as 

various methods through which efficacy 

can be visually represented. We have 

chosen to investigate three different 

formats: Bar graph, pictograph, and pie 

chart. Type of statistic is defined as the 

type of statistical information conveyed: 

Frequency, relative frequency, or 

percentage. These factors will be 

combined in a partially crossed factorial 

design as follows: 

TABLE 1.—TYPE OF VISUAL FORMAT X TYPE OF STATISTIC CONVEYED X EFFICACY LEVEL

Type of Visual Format 

Type of Statistic Efficacy Level None Pie Chart Bar Chart Pictograph 

Frequency High Efficacy ✓ ✓ ✓ ✓ 

Low Efficacy ✓ ✓ ✓ ✓ 

Percentage High Efficacy ✓ ✓ ✓ N/A 

Low Efficacy ✓ ✓ ✓ N/A 

Combination Frequency + Percentage High Efficacy ✓ N/A N/A N/A 

Low Efficacy ✓ N/A N/A N/A 

Relative Frequency High Efficacy ✓ N/A N/A N/A 

Low Efficacy ✓ N/A N/A N/A 

Relative Frequency + Absolute Rate High Efficacy ✓ N/A N/A N/A 

Low Efficacy ✓ N/A N/A N/A 

None N/A ✓ N/A N/A N/A 

The test product will be for the 

treatment of high cholesterol and 

modeled on an actual drug used to treat 

that condition (such as Lipitor©). The 

product labeling will be used as the 

reference for defining the high- and lowefficacy levels and the objective metrics 

for clinical performances. Because both 

parts of the study will run concurrently, 

experimental conditions will be 

identical in both the print and television 

portions. 

Participants will read or view one ad 

version. After reading the ad, 

participants will make a series of 

judgments about the drug. The mean 

difference between the low- and highefficacy condition will serve as the 

baseline for testing whether this 

difference varies across various 

graphical presentations, with the 

exception of the No Information 

(control) condition. In other words, our 

analyses will involve two steps. In step 

1, within each format, we will test 

whether participants were able to 

distinguish between low- and highefficacy drugs. In step 2, within each 

efficacy level, we will test whether 

participants’ estimates of efficacy differ 

across formats and examine the 

accuracy of these estimates. 

Interviews are expected to last no 

more than 20 minutes. A total of 4,500 

participants will be involved in the 2 

parts of the study. This will be a one 

time (rather than annual) collection of 

information. 

FDA estimates the burden of this 

collection of information as follows: 

The total respondent sample for this 

data collection is 4,500 (2,225 in each 

part). We estimate the response burden 

to be 20 minutes, for a burden of 1,485 

hours. 

The response burden chart is listed in 

table 2 of this document. 

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

4,500 1 4,500 .33 1,485 

Total 4,500 1 4,500 .33 1,485 

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


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 74, No. 118 / Monday, June 22, 2009 / Notices 29493 

Dated: June 15, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–14501 Filed 6–19–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Cross-Site Evaluation of the 

Infant Adoption Awareness Training 

Program for Projects Initially Funded in 

Fiscal Year 2006–NEW. 

OMB No.: New Collection. 

Description: The Administration for 

Children and Families (ACF), Childrens 

Bureau (CB), will conduct the Cross-Site 

Evaluation of the Infant Adoption 

Awareness Training Program (IAATP). 

Title XII, subtitle A, of the Childrens 

Health Act of 2000 (CHA) authorizes the 

Department of Health and Human 

Services to make Infant Adoption 

Awareness Training grants available to 

national, regional, and local adoption 

organizations for the purposes of 

developing and implementing programs 

that train the staff of public and nonprofit private health service 

organizations to provide adoption 

information and referrals to pregnant 

women on an equal basis with all other 

courses of action included in nondirective counseling of pregnant 

women. Participants in the training 

include individuals who provide 

pregnancy or adoption information and 

those who will provide such services 

after receiving the training, with Title X 

(relating to voluntary family planning 

projects), section 330 (relating to 

community health centers, migrant 

health centers, and centers serving 

homeless individuals and residents of 

public housing), and CHA-funded 

school-based health centers, receiving 

priority to receive the training. A total 

of six organizations were awarded 

IAATP funding in 2006. 

Section 1201(a)(2)(A) of the IAATP 

legislation requires grantees to develop 

and deliver trainings that are consistent 

with the Best Practice Guidelines for 

Infant Adoption Awareness Training. 

The IAATP guidelines address training 

goals, basic skills, curriculum and 

training structure. A complete 

description of the guidelines is available 

at http://www.acf.hhs.gov/programs/cb/ 

programs_fund/discretionary/iaatp.htm. 

In addition, grantees are required to 

conduct local evaluation of program 

outcomes and participate in the national 

evaluation of the extent to which IAATP 

training objectives are met. The Infant 

Adoption Awareness Training Program: 

Trainee Survey is the primary data 

collection instrument for the national 

cross-site evaluation. Respondents will 

complete the survey prior to receiving 

training and approximately 90 days after 

the training to assess the extent to 

which trainees demonstrate sustained 

gains in their knowledge about 

adoption, and to determine the impact 

of the training on their subsequent work 

with pregnant women. 

1. Do health care workers who 

participate in the IAATP training: 

Demonstrate enhanced knowledge, 

attitudes, skills, and behaviors with 

respect to adoption counseling 

following completion of the program? 

Provide adoption information to 

pregnant women on an equal basis with 

other pregnancy planning options? 

Demonstrate enhanced awareness of 

community adoption-related resources 

and refer expectant mothers to them as 

needed? 

2. Are trainees more confident about 

discussing all three pregnancy planning 

options (parenting, abortion, and 

adoption) in a non-directive counseling 

style than they were prior to 

participating in the training? Cross-site 

evaluation data will be collected on an 

annual basis throughout the five-year 

funding period. Pre-test and follow-up 

versions of the survey are expected to 

require approximately 10 to 15 minutes 

to complete. Estimated response time 

for the follow-up survey includes time 

for respondents to access the Web-based 

survey, complete the survey online, and 

electronically submit the survey. 

Respondents will not need to 

implement a recordkeeping system or 

compile source data in order to 

complete the survey. Where possible, 

fields in the follow-up version of the 

survey will be pre-filled with static data 

from the respondents pre-test (e.g., 

demographics, agency type) in order to 

further expedite completion of the 

survey and minimize respondent 

burden. 

Respondents: Infant Adoption 

Awareness Program Trainees. 

ANNUAL BURDEN ESTIMATES

Instrument Number of respondents 

Number of responses per 

respondent 

Average burden hours per 

response 

Total burden 

hours 

IAATP: Trainee Survey Pre-Test Administration ............................................. 1,200 1 0.15 180 

IAATP: Trainee Survey Follow-Up Administration ........................................... 1,200 1 0.10 120 

Estimated Total Annual Burden Hours: 300. 

Additional Information 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: 

Office of Management and Budget, 

Paperwork Reduction Project, Fax: 202– 

395–6974, Attn: Desk Officer for the 

Administration for Children and 

Families. 


pwalker on PROD1PC71 with NOTICES