Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Notices 11889 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0133] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Experimental 

Evaluation of Variations in Content and 

Format of the Brief Summary in Directto-Consumer Print Advertisements for 

Prescription Drugs 

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 

(the PRA). 

DATES: Fax written comments on the 

collection of information by April 13, 

2007. 

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: 

202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

1482. 

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. 

Experimental Evaluation of Variations 

in Content and Format of the Brief 

Summary in Direct-to-Consumer Print 

Advertisements for Prescription 

Drugs—(OMB Control Number 0910–

0591) 

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 903(b)(2)(c) of the Federal Food, 

Drug, and Cosmetic Act (the 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 act. 

Under the act, a drug is misbranded if 

its labeling or advertising is false or 

misleading. In addition, section 502(n) 

of the act (21 U.S.C. 352(n)) specifies 

that advertisements for prescription 

drugs and biological products must 

provide a true statement of information 

‘‘in brief summary’’ about the advertised 

product’s ‘‘side effects, 

contraindications, and effectiveness.’’

The prescription drug advertising 

regulations (§ 202.1(e)(3)(iii) (21 CFR 

202.1(e)(3)(iii))) specify that the 

information about risks must include 

‘‘each specific side effect and 

contraindication’’ from the advertised 

drug’s approved labeling. The regulation 

also specifies that the phrase ‘‘side 

effect and contraindication’’ refers to all 

of the categories of risk information 

required in the approved product 

labeling written for health professionals, 

including the warnings, precautions, 

and adverse reactions sections. Thus, 

every risk in an advertised drug’s 

approved labeling must be included to 

meet these regulations. 

In recent years, FDA has become 

concerned about the adequacy of the 

brief summary in Direct-to-Consumer 

(DTC) print advertisements. Although 

advertising of prescription drugs was 

once primarily addressed to health 

professionals, increasingly consumers 

have become a target audience, as DTC 

advertising has dramatically increased 

in the past few years. 

Because the regulations do not specify 

how to include each risk, sponsors can 

use discretion in fulfilling the brief 

summary requirement under 

§ 202.1(e)(3)(iii). Frequently, sponsors 

print in small type, verbatim, the riskrelated sections of the approved product 

labeling (also called the package insert, 

professional labeling, or prescribing 

information). This labeling is written for 

health professionals, using medical 

terminology. FDA believes that while 

this is one reasonable way to fulfill the 

brief summary requirement for print 

advertisements directed toward health 

professionals, this method is difficult 

for consumers to understand and 

therefore may not be the best approach 

to communicate this important 

information to them. 

In 2004, FDA published a draft 

guidance entitled ‘‘Brief Summary: 

Disclosing Risk Information in 

Consumer-Directed Print 

Advertisements’’ (available at http:// 

www.fda.gov/cder/guidance/ 

5669dft.htm). This guidance outlined 

possible options for improving the 

communication of risk information to 

consumers in specific promotional 

pieces. When discussing the current 

professional prescribing information 

format, the guidance states that the 

‘‘volume of the material, coupled with 

the format in which it is presented... 

discourages its use and makes the 

information less comprehensible to 

consumers.’’ The draft guidance 

suggested three possible presentations 

for the brief summary, including the 

current prescribing information format, 

an approved patient package insert, or 

highlights from the physician labeling 

rule. 

In the content study, FDA plans to 

investigate the role of context in 

providing useful risk information to 

consumers. It has been theorized that 

long lists of minor risks may detract 

from the understanding of more serious 

risks, as stated in the draft guidance. 

Nonetheless, if the risk information is 

presented with proper supporting 

context, people may find the 

information facilitates rather than 

distracts from the understanding of the 

risk information. One of the two 

proposed studies in this notice will 

investigate the context that may 

contribute to this facilitation. 

In addition to context, format also 

plays a role in the clarity and 

understanding of the brief summary. 

FDA proposes to collect information on 

the usefulness of different formats 

suggested in the draft guidance. In 

addition to the patient package insert, 

which is usually presented in a question 

and answer format, FDA proposes to test 

a consumer-friendly highlights format, 

as well as a format based on the drug 

facts labeling used for over-the-counter 

drugs. 

Data from these two studies will 

converge to allow a better assessment of 

various ways to present risk information 

in a print advertisement for a 

prescription drug. 

FDA estimates that 1,800 individuals 

will need to be screened to obtain a 

respondent sample of 900 for the 

content study and that 600 individuals 

will need to be screened to obtain a 

respondent sample of 300 for the format 

study. The screener is expected to take 

30 seconds, for a total screener burden 

of 41 hours. The 1,200 respondents in 

the two studies will then be asked to 

respond to a series of questions about 

the advertisement. We estimate the 

response burden for each of the two 

studies to be 20 minutes, for a burden 

of 396 hours. The estimated total burden 

for this data collection effort is 437 

hours. 

In the Federal Register of April 25, 

2006 (71 FR 23921), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. Seven comments were 

received, and none were PRA related. 

Five comments were from individual 

citizens, one comment was from 

AstraZeneca, a member of industry, and 


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11890 Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Notices 

1Lavie, N. (2001). Capacity limits in selective 

attention: Behavioral evidence and implications for 

neural activity. In Braun, J., Koch, C., et al. (Eds.), 

Visual attention and cortical circuits. Cambridge, 

MA: The MIT Press (pp. 49–68); Shapiro, K. (Ed.) 

(2001). The limits of attention: Temporal 

constraints in human information processing. 

London: Oxford University Press. 

2See, e.g., Stotka, J.L., Rotelli, M.D., Dowsett, 

S.A., Elsner, M.W., Holdsworth, S.M., et al. (2007). 

A new model for communicating risk information 

in direct-to-consumer print advertisements. Drug 

Information Journal, 41, 111–127. 

3See, e.g., http://www.fda.gov/ohrms/dockets/ 

dockets/05n0354/05N-0354-EC444-Attach-1.pdf; 

Washington Legal Foundation response to the 

Division of Drug Marketing, Advertising, and 

Communications regarding WellSpring 

Pharmaceutical Corp. at http://www.wlf.org/ 

Resources/DDMAC/default.asp. (FDA has verified 

the Web site address, but FDA is not responsible for 

any subsequent changes to the Web site after this 

document publishes in the Federal Register.) 

4Available at http://www.fda.gov/cder/guidance/ 

1804fnl.htm. (Last accessed March 8, 2007.) 

5For example, the Association of Clinicians for 

the Underserved states, ‘‘These new labels should 

assist consumers in the selection of Over the 

Counter (OTC) products by enabling them to assess 

drugs’ risks and benefits more easily.’’ (http:// 

www.clinicians.org/programsandservices/rxfiles/ 

patient_education_safety.html) (FDA has verified 

the Web site address, but FDA is not responsible for 

any subsequent changes to the Web site after this 

document publishes in the Federal Register.) 

6Marietta, A.B., Welshimer, K.J., and Anderson, 

S.L. (1999). Knowledge, attitudes, and behaviors of 

college students regarding the 1990 Nutrition Label 

Education Act food labels. Journal of the American 

Dietetic Association, 99, 445–449. 

one comment was from a health care 

coalition, the Clear Language Group. 

Most of the comments addressed the 

proposed content study. 

The five comments from individual 

citizens were identical. They stated, 

‘‘Deny the drug industry petition. Show 

all side effects.’’ These comments show 

a lack of understanding of the relevant 

issues. This proposed information 

collection is not a pharmaceutical 

industry petition; it is a research project 

supported by funds received from the 

Office of Medical Policy within the 

Center for Drug Evaluation and 

Research, part of FDA. The goal of this 

research is to further the public health 

by improving the readability and 

functionality of the brief summary in 

print ads, an easily accessed forum for 

information. Research in cognitive 

psychology overwhelmingly suggests 

that people have limited capacity for 

information and cannot process endless 

lists.1 Recent research has suggested 

that providing a small number of the 

more minor side effects may actually 

improve the understanding of the 

benefit-risk tradeoff of the drug as a 

whole.2 FDA wants to ensure that the 

presentation of risk information is in the 

best interests of consumers. This 

research will provide empirical 

evidence to support the optimal 

presentation of side effects. 

In the sixth comment, AstraZeneca 

supported the proposed research as a 

method to create more consumerfriendly brief summaries. They 

requested that the research be delayed, 

however, until the data from study 1 is 

collected. If this were not possible, they 

requested that the comment period 

remain open until commenters have the 

ability to look at the questionnaire 

materials. Study 1 is currently in the 

field and we expect to have data 

available by the midpoint of the year. 

These results will be analyzed in the 

next several months. Given the interest 

in the finalization of the brief summary 

guidance,3 which in part relies on 

information from these studies, we 

cannot delay the development of studies 

2 and 3 until data from study 1 are 

analyzed and interpreted. Questionnaire 

materials are available for public 

comment through FDA’s Office of 

Information Review Management. 

Comments may be submitted to the 

docket at any time, even after the docket 

has closed. 

The final comment was submitted by 

Sarah Furnas as a representative of the 

Clear Language Group, a consortium of 

plain language consultants, and 

involved two primary concerns. The 

first concern regarded our plan to 

recruit and divide respondents into 

education groups of completed college 

or some college or less. This division 

may limit our ability to make finer 

distinctions among educational groups. 

Moreover, Furnas suggests that people 

who struggle with obesity fall 

disproportionately into the lower 

education groups. If FDA chose a 

division point that represents a fairly 

high level of education, they may recruit 

more people from the highest education 

group, thus leaving out an appropriate 

proportion of lower education 

individuals. Furnas suggests using the 

educational breakdown used by the 

American Obesity Association: 4+ years 

of college, some college, high school 

graduate, and some high school. FDA 

agrees and will incorporate this 

suggestion into the questionnaire. 

This commenter also expressed 

concern that the options in our research 

design require high numeracy and 

document literacy skills. Furnas 

suggested that FDA omit some of the 

design options and perhaps add other, 

easier options. First, although FDA 

shares the goal of making documents 

easier to read and would like to make 

the brief summary accessible to the 

greatest number of people possible, at 

some level, people who have difficulty 

reading will not seek out a written 

explanation of risks. In its guidance 

Consumer Directed Broadcast 

Advertisements,4 the agency suggested a 

number of ways complete risk 

information could be obtained by 

consumers, including a toll-free 

telephone number, making this option a 

good choice for those who have 

difficulty reading health information. 

Consumers who have difficulty 

reading may not seek out medical 

information in a print advertisement, 

especially in its current form. However, 

the very nature of the information in the 

brief summary is the communication of 

risk information which is at its heart 

probability-based. By limiting their 

options, FDA not only fails to 

empirically determine the best option 

for the greatest number of people, but 

they may fail to appropriately inform 

the people who are most likely to read 

the advertisement and the brief 

summary. Therefore, FDA is testing 

ways to better communicate this 

information. 

Second, FDA does not agree that table 

formats are more difficult to read than 

lists of information in paragraph format. 

The over-the-counter labeling change of 

1999 (21 CFR 201.66), requiring a 

presentation of Drug Facts in a table 

format, has received positive reviews for 

its improvement over older labels.5

Moreover, the Nutrition Facts label 

required as part of the Nutrition 

Labeling and Education Act of 1990 has 

also received praise for its easier-tounderstand format.6 These two tablebased formats have been in the public 

domain for several years now, making 

them familiar to consumers. 

Nonetheless, FDA has changed its 

design based on other factors and will 

not be examining a chart or table format. 

FDA acknowledges that placebo may 

be a fairly complex concept for many 

people. One of the research goals is to 

determine whether the addition of 

context may improve the 

understandability or usefulness of the 

brief summary as a whole. The value of 

an experimental design is that FDA will 

be able to empirically test whether or 

not their manipulations have an effect. 

Therefore, FDA has chosen two other 

forms of context, the frequency of side 

effects, and the temporal nature of sideeffects, in place of placebo rate. FDA 

will be able to determine which groups 

have more or less difficulty with each 

condition. It is likely that at least some 

people will value the addition of this 

information. 

In the interest of communicating to as 

many people as possible, FDA has 

changed the format of the rate 

information. Instead of providing this 


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Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Notices 11891 

information in percentages, FDA will 

provide this information as, ‘‘x out of 

100.’’ FDA thanks this commenter for 

bringing these issues to their attention. 

As a result of the comments, the 

agency received and some further 

thought on the design of the studies, 

FDA has altered the designs somewhat. 

The following are the revised designs. 

Content Study 

Design Overview: This study will 

employ a between-subjects crossed 

factorial design using a mall-intercept 

protocol. We will manipulate the minor 

side effect section, varying the presence 

of frequency information and the 

presence of framing, and the efficacy 

section, varying the presence of 

frequency information. We are 

interested in how these changes 

influence the understanding of the risks 

of the product as a whole, particularly 

the more serious risk sections. If these 

changes enhance or, at the very least, do 

not detract from the major risks, then 

these additions of context may be 

something to include in future brief 

summaries. In the best case scenario, we 

find context that enhances the total 

picture of the drug and does not 

interfere with the processing of the 

major risks. 

Primary Research Questions 

a. Will the presence of information on 

the frequency of minor side effects 

influence the readers’ comprehension of 

the major risks? Will the comprehension 

of major risks vary depending on 

whether the frequencies are high or 

low? 

b. Will the presence of information on 

the temporal duration of minor side 

effects influence the comprehension of 

the major risks? 

c. Will the presence of clinical 

efficacy information influence readers’

comprehension of the major risks? Will 

the comprehension of the major risks 

vary depending on whether clinical 

efficacy is high or low? 

d. Will clinical efficacy and frequency 

of minor side effects interact to 

influence comprehension of major risks? 

Will clinical efficacy and temporal 

duration interact to influence 

comprehension of major risks? 

Procedure: Participants will be shown 

one advertisement. Then a structured 

interview will be conducted with each 

participant to examine a number of 

important perceptions about the brief 

summary, including perceived riskiness 

of the drug, comprehension of 

information in the brief summary, and 

perceived usefulness of brief summary 

information. Finally, demographic and 

health care utilization information will 

be collected. Interviews are expected to 

last approximately 20 minutes. A total 

of 900 participants will be involved. 

This will be a one-time (rather than 

annual) collection of information. 

Format Study 

Design Overview: This study will 

employ a between-subjects crossed 

factorial design using a mall-intercept 

protocol. Four print advertisements will 

be created using four different formats: 

Traditional long format, Question and 

Answer, Highlights (71 FR 3922, 

January 24, 2006), and Drug Facts (21 

CFR 201.66). As much as possible, the 

information in the formats will be 

constant across conditions. Participants 

who self-identify as being in the target 

market for the condition will be asked 

to read a single print advertisement for 

a new prescription drug. After reading 

the advertisement, they will be asked 

questions about their comprehension 

and evaluation of the information 

presented in the advertisement. Lastly, 

participants will be shown all four 

versions and asked to rate them relative 

to one another on measures assessing 

visual appeal, preference, and 

information accessibility. 

Primary Research Questions 

a. Will alternative formats influence 

the comprehension of major risks, 

behavioral intentions, and/or selfefficacy? 

b. Which format will consumers 

prefer? 

Procedure: Participants will be shown 

one advertisement. Then a structured 

interview will be conducted with each 

participant to examine a number of 

important perceptions about the brief 

summary, including perceived riskiness 

of the drug, comprehension of 

information in the brief summary, and 

perceived usefulness of brief summary 

information. Finally, demographic and 

health care utilization information will 

be collected. Interviews are expected to 

last approximately 20 minutes. A total 

of 300 participants will be involved. 

This will be a one-time (rather than 

annual) collection of information. 

FDA estimates the burden of this 

collection of information as follows: 

FDA estimates that 1,800 individuals 

will need to be screened to obtain a 

respondent sample of 900 for the 

Content study, and 600 individuals will 

need to be screened to obtain a 

respondent sample of 300 for the Format 

study. The screener is expected to take 

30 seconds in each study, for a total 

screener burden of 41 hours. The 1,200 

respondents in the two studies will then 

be asked to respond to a series of 

questions about the advertisement. We 

estimate the response burden for each of 

the two studies to be 20 minutes, for a 

burden of 396 hours. The estimated total 

burden for this data collection effort is 

437 hours. The respondent burden is 

listed in table 1 of this document. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of Respondents Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

1,800 (content study: screener) 1 1,800 .017 31 

900 (content study: questionnaire) 1 900 .33 297 

600 (format study: screener) 1 600 .017 10 

300 (format study: questionnaire) 1 300 .33 99 

Total 437 

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


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11892 Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Notices 

Dated: March 7, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–4556 Filed 3–13–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications 

and/or contract proposals and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material, and 

personal information concerning 

individuals associated with the grant 

applications and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel, Home 

Centered Coordinated Cancer Care System. 

Date: April 4, 2007. 

Time: 12 p.m. to 3 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6116 

Executive Boulevard, Conference Room 706, 

Bethesda, MD 20892. (Telephone Conference 

Call). 

Contact Person: Gerald G. Lovinger, PhD, 

Scientific Review Administrator, Special 

Review and Logistics Branch, Division of 

Extramural Activities, National Cancer 

Institute, 6116 Executive Blvd., Room 8101, 

Bethesda, MD 20892–8329. 301/496–7987. 

lovingeg@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel, Quantiative 

Assay for O6—Carboxymethyl Guanine DNA 

Adducts. 

Date: April 5, 2007. 

Time: 12 p.m. to 4 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6116 

Executive Boulevard, Conference Room 611, 

Bethesda, MD 20892. (Telephone Conference 

Call). 

Contact Person: C. Michael Kerwin, PhD, 

MPH, Scientific Review Administrator, 

Special Review and Logistics Branch, 

Division of Extramural Activities, National 

Cancer Institute, NIH, 6116 Executive Blvd., 

Rm. 8057, Bethesda, MD 20892–8329, 301–

496–7421. kerwinm@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel, CA 07–032, 

‘‘Improved Measures of Diet and Physical 

Activity for the Genes and Environment 

Initiative (GEI) (UO1)’’. 

Date: April 18–19, 2007. 

Time: 9 a.m. to 3:30 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: Marriott Gaithersburg 

Washingtonian Center, 951 Washingtonian 

Boulevard, Gaithersburg, MD 20878. 

Contact Person: Thomas M. Vollberg, PhD, 

Scientific Review Administrator, Special 

Review and Logistics Branch, Division of 

Extramural Activities, National Cancer 

Institute, 6116 Executive Blvd., Room 7142, 

Bethesda, MD 20892. 301–594–9582. 

vollbert@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

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Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: March 7, 2007. 

Anna Snouffer, 

Acting Director, Officer of Federal Advisory 

Committee Policy. 

[FR Doc. 07–1190 Filed 3–13–07; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

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National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

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provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

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applications, the disclosure of which 

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Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel, 

Conference Grants (R13). 

Date: April 6, 2007. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

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Contact Person: Valerie L. Prenger, PhD, 

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0270. prengerv@nhlbi.nih.gov. 

Name of Committee: National Heart, Lung, 

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Ancillary Studies in Clinical Trials. 

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Contact Person: Yingying Li-Smerin, MD, 

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435–0277. lismerin@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

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Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

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Dated: March 6, 2007. 

Anna Snouffer, 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–1184 Filed 3–13–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

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National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

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