Federal Register / Vol. 74, No. 63 / Friday, April 3, 2009 / Notices 15293 

1For prescription drugs and biologics, 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., Woloshin, S., Black, W., and 

Welch, H.G., ‘‘The role of numeracy in 

understanding the benefit of screening 

mammography,’’Annals of Internal Medicine, 

127(11), 966–72, 1997. 

manufacture, distribution, dispensing, 

possession, or use of a controlled 

substance is prohibited in the grantee’s 

workplace and specifying the actions 

that will be taken against employees for 

violation of such prohibition; 

(2) Establishing an ongoing drug-free 

awareness program to inform employees 

about— 

(a) The dangers of drug abuse in the 

workplace; 

(b) The grantee’s policy of 

maintaining a drug-free workplace; 

(c) Any available drug counseling, 

rehabilitation, and employee assistance 

programs; and 

(d) The penalties that may be imposed 

upon employees for drug abuse 

violations occurring in the workplace; 

(3) Making it a requirement that each 

employee to be engaged in the 

performance of the grant be given a copy 

of the statement required by paragraph 

(a); 

(4) Notifying the employee in the 

statement required by paragraph (a) that, 

as a condition of employment under the 

grant, the employee will— 

(a) Abide by the terms of the 

statement; and 

(b) Notify the employer in writing of 

his or her conviction for a violation of 

a criminal drug statute occurring in the 

workplace no later than five calendar 

days after such conviction; 

(5) Notifying the agency in writing, 

within 10 calendar days after receiving 

notice under paragraph (d)(2) from an 

employee or otherwise receiving actual 

notice of such conviction. Employers of 

convicted employees must provide 

notice, including position title, to every 

grant officer or other designee on whose 

grant activity the convicted employee 

was working, unless the Federal agency 

has designated a central point for the 

receipt of such notices. Notice shall 

include the identification number(s) of 

each affected grant; 

(6) Taking one of the following 

actions, within 30 calendar days of 

receiving notice under paragraph (d)(2), 

with respect to any employee who is so 

convicted— 

(a) Taking appropriate personnel 

action against such an employee, up to 

and including termination, consistent 

with the requirements of the 

Rehabilitation Act of 1973, as amended; 

or 

(b) Requiring such employee to 

participate satisfactorily in a drug abuse 

assistance or rehabilitation program 

approved for such purposes by a 

Federal, State, or local health, law 

enforcement, or other appropriate 

agency; 

(7) Making a good faith effort to 

continue to maintain a drug-free 

workplace through implementation of 

paragraphs (a), (b), (c), (d), (e) and (f). 

The grantee may insert in the space 

provided below the site(s) for the 

performance of work done in 

connection with the specific grant: 

Place of Performance (Street address, 

city, county, state, zip code) 

lllllllllllllllllll

lllllllllllllllllll

Check if there are workplaces on file 

that are not identified here. 

Alternate II. (Grantees Who Are 

Individuals) 

(1) The grantee certifies that, as a 

condition of the grant, he or she will not 

engage in the unlawful manufacture, 

distribution, dispensing, possession, or 

use of a controlled substance in 

conducting any activity with the grant; 

(2) If convicted of a criminal drug 

offense resulting from a violation 

occurring during the conduct of any 

grant activity, he or she will report the 

conviction, in writing, within 10 

calendar days of the conviction, to every 

grant officer or other designee, unless 

the Federal agency designates a central 

point for the receipt of such notices. 

When notice is made to such a central 

point, it shall include the identification 

number(s) of each affected grant. 

[FR Doc. E9–7502 Filed 4–2–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0589] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Mental Models 

Study of Health Care Providers’ 

Understanding of Prescription Drug 

Effectiveness 

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 May 4, 

2009. 

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, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–NEW and 

title ‘‘Mental Models Study of Health 

Care Providers’ Understanding of 

Prescription Drug Effectiveness.’’ Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792. 

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. 

Mental Models Study of Health Care 

Providers’ Understanding of 

Prescription Drug Effectiveness 

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 

this risk information is likely to evoke 

active trade-offs by consumers and 

physicians, i.e., comparisons with the 

perceived risks of not taking a 

treatment, and comparisons with the 

perceived benefits of taking a 

treatment.2 The FDA has an interest in 

fostering safe and proper use of 

prescription drugs, which is an activity 

that necessitates understanding of both 

risks and benefits. Thus, an indepth 

understanding of physicians’ processing 

of this information, their thinking on 

relevant topics, and their informational 

needs are 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 


sroberts on PROD1PC70 with NOTICES
15294 Federal Register / Vol. 74, No. 63 / Friday, April 3, 2009 / Notices 

3Woloshin, S. and Schwartz, L., ‘‘Direct to 

consumer advertisements for prescription drugs: 

what are Americans being told,’’ Lancet, 358, 1141– 

46, 2001. 

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. 

This proposed data collection will 

provide FDA with insight for evaluating 

and improving current communication 

procedures. It is designed to identify 

knowledge gaps for FDA to address, 

which would ultimately improve 

practitioner decisionmaking and hence 

the health outcomes of the affected 

patients. This new information 

collection uses ‘‘Mental Modeling,’’ 

which is a qualitative research method 

that compares a model of the 

decisionmaking processes of a group or 

groups to a model of the same process 

developed from expert knowledge and 

experience. In this study, the decision 

models of health care providers 

concerning their understanding of drug 

product efficacy and how they 

communicate their understanding to 

their patients will be compared to a 

model derived from the knowledge and 

experience of experts who review 

product labeling for the purpose of 

ensuring that prescribers get the 

information they need to make optimal 

prescribing decisions. FDA will use 

telephone interviews to determine from 

the health care providers the factors that 

influence their understanding of drug 

product efficacy and how they 

communicate their understanding to 

their patients. Comparing expert and 

health care provider responses will 

allow for a richer understanding of 

decisions determining drug product 

efficacy from labeling and other sources 

and how this understanding is 

communicated to their patients. 

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 and 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.3 In a 

study involving a content analysis of 

direct-to-consumer (DTC) advertising, 

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 sideeffects that generally occurred 

infrequently. 

Additional research is necessary to 

uncover important information about 

how consumers understand 

effectiveness information about 

prescription drug products from DTC 

advertisements. 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 qualitative 

information in this Mental Models 

phase of the research will provide a 

preliminary framework and help FDA 

craft subsequent quantitative studies. 

Overview. The proposed information 

collection will use ‘‘mental modeling,’’ 

a qualitative research method wherein 

the decisionmaking processes of a group 

of physician respondents concerning the 

effectiveness of various prescription 

drug products are modeled and 

compared to a model based on expert 

labeling knowledge and clinical 

experience in drug effectiveness. The 

information will be collected by 

telephone interviews concerning the 

factors that influence perceptions and 

decisions related to drug effectiveness. 

This method will help identify 

physicians’ beliefs, priorities, 

informational needs, visions and 

conceptualizations about how well 

particular drugs work. A comparison 

between expert and physician models 

based on the collected information may 

identify ‘‘consequential knowledge 

gaps’’ that can be redressed through 

labeling changes as well as helping FDA 

focus future quantitative research on the 

communication of drug benefit 

information. Thus, the information to be 

collected will be used by FDA to 

develop and strengthen research 

materials and design in future planned 

quantitative experiments. 

The first step in the mental models 

process is to conduct background 

research to develop a model based on 

both experts’ current knowledge and 

extant literature on drug effectiveness. 

The resulting ‘‘simple expert model’’ is 

a mapping of decisionmaking factors, 

relationships and influences, and is 

used to develop an interview protocol 

for a day-long workshop with experts, 

hereafter referred to as the ‘‘expert 

elicitation.’’ 

The expert elicitation was conducted 

November 28, 2007. It included nine 

experts from a variety of medical fields, 

including those versed in drug labeling 

issues and others with extensive clinical 

experience, particularly involving two 

medical conditions (insomnia, a 

medical condition frequently treated by 

general practitioners, and rheumatoid 

arthritis, a condition likely treated by 

specialists). Six experts were internal to 

FDA, two experts were from the 

National Institutes of Health, and one 

expert was external to the Federal 

Government, from the Association of 

Medical Colleges. The expert elicitation 

process does not solicit advice, 

opinions, or recommendations from the 

group, but instead tries to determine 

how each expert perceives the factors 

related to consumer decisionmaking, 

from their particular expert field. 

Results from the expert elicitation were 

used to develop the expert model, 

which generally includes adding new 

concepts and supporting details to the 

existing simple expert model. The new 

draft expert model was validated during 

a subsequent teleconference with the 

research team about a month following 

the initial elicitation. Following the 

validation, the project team finalized the 

expert model. 

The expert model informs the 

development of the physician interview 

guide for physician telephone 

interviews. Mental models research is 

typically conducted with cohorts of 

respondents who represent categories of 

people whose mental models are to be 

compared, both individually with the 

expert model and between cohorts, 

identifying the potential for significant 

differences among cohorts. Interviews 

will be conducted with 40 health care 

providers to develop a mental model 

describing how each of 2 cohorts learns 

about drug product efficacy and how 

their understanding about efficacy is 

communicated to their patients. The 

cohorts are as follows: 

(1) Primary care providers. This 

cohort includes office-based 

practitioners in primary care (general 

practice, family practice, and internal 

medicine) with at least 3 years of 

experience and who engage in patient 

care at least 50 percent of the time. 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 74, No. 63 / Friday, April 3, 2009 / Notices 15295 

(2) Specialists. This cohort includes 

office-based practitioners in 

rheumatology with at least 3 years of 

experience and who engage in patient 

care at least 50 percent of the time. 

Cohorts will be identified and 

recruited to represent a reasonable range 

of age, gender, and ethnicity. 

Within each cohort, 20 practitioners 

will be interviewed by trained 

interviewers in one-on-one in-depth 

telephone interviews. A sample size of 

40 (approximately 20 primary care 

providers and 20 rheumatologists) is 

sufficiently large for the qualitative 

findings to capture a wide depth and 

range of people’s thinking. The 

interviews will take approximately 45 

minutes. The health care provider 

interviews will be used to create a 

mental model of physician 

decisionmaking factors with respect to 

drug product effectiveness. 

Potential physician participants will 

be randomly identified through a 

purchased list based on the American 

Medical Association’s (AMA) Physician 

Masterfile. This list tracks all 

physicians, M.D. (doctor of medicine) 

and DO (doctor of osteopathic 

medicine), practicing in the United 

States, not only members of the AMA. 

FDA intends this collection to be used 

as formative research. As with our focus 

group research (OMB control number 

0910–0360), the results of this formative 

research will provide direction toward 

potential areas of focus. Further 

research is necessary, and planned, to 

test concepts obtained from these 

results. This research will be useful in 

designing survey questions for the next 

phases of this research project (which 

will be submitted for approval at a later 

date). 

In the Federal Register of November 

24, 2008 (73 FR 71006), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours Per 

Response Total Hours 

21 U.S.C. 393(b)(2)(c) Questionnaire, Pretesting 4 1 4 .75 3 

21 U.S.C. 393(b)(2)(c) Questionnaire, Study 40 1 40 .75 30 

Total 33 

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

Dated: March 27, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–7471 Filed 4–2–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0653] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Filing Objections 

and Requests for a Hearing on a 

Regulation or Order 

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 May 4, 

2009. 

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, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0184. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

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. 

Filing Objections and Requests for a 

Hearing on a Regulation or Order— 

(OMB Control Number 0910–0184)— 

Extension 

The regulations in 21 CFR 12.22, 

issued under section 701(e)(2) of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 371(e)(2)), set forth 

the instructions for filing objections and 

requests for a hearing on a regulation or 

order under § 12.20(d) (21 CFR 

12.20(d)). Objections and requests must 

be submitted within the time specified 

in § 12.20(e). Each objection, for which 

a hearing has been requested, must be 

separately numbered and specify the 

provision of the regulation or the 

proposed order. In addition, each 

objection must include a detailed 

description and analysis of the factual 

information and any other document, 

with some exceptions, supporting the 

objection. Failure to include this 

information constitutes a waiver of the 

right to a hearing on that objection. FDA 

uses the description and analysis to 

determine whether a hearing request is 

justified. The description and analysis 

may be used only for the purpose of 

determining whether a hearing has been 

justified under 21 CFR 12.24 and do not 

limit the evidence that may be 

presented if a hearing is granted. 

Respondents to this information 

collection are those parties that may be 

adversely affected by an order or 

regulation. 

In the Federal Register of January 14, 

2009 (74 FR 2080), FDA published a 60- 

day notice requesting public comment 

on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 


sroberts on PROD1PC70 with NOTICES