Federal Register / Vol. 75, No. 85 / Tuesday, May 4, 2010 / Notices 23775 

1Public Law 104–180, August 6, 1996, Title VI. 

Effective Medication Guides. 

2 21 CFR part 208. 

3 21 CFR 310.501 and 310.515. 

Approximately 30,000 respondents of 

a Web-based consumer panel will be 

screened (3 waves (independent 

surveys)) for each of 5 incidents; 2,000 

respondents per wave). We estimate that 

it will take a respondent 20 seconds 

(0.0055 hours) to complete the screening 

questions, for a total of 165 hours. We 

will conduct a pre-test of the first survey 

with 40 respondents; we estimate that it 

will take a respondent 10 minutes 

(0.167 hours) to complete the pre-test, 

for a total of 7 hours. Fifteen thousand 

(15,000) respondents will complete the 

surveys (3 waves (independent surveys)) 

for each of 5 incidents; 1,000 

respondents per wave). We estimate that 

it will take a respondent 10 minutes 

(0.167 hours) to complete the survey, for 

a total of 2,505 hours. Thus, the total 

estimated burden is 2,677 hours. FDA’s 

burden estimate is based on prior 

experience with consumer surveys that 

are similar to these. 

II. References 

1. Cuite, C., S. Condry, M. Nucci, et al., 

‘‘Public Response to the Contaminated 

Spinach Recall of 2006,’’ Publication no. RR– 

0107–013, New Brunswick, NJ: Rutgers, the 

State University of New Jersey, Food Policy 

Institute, 2007. 

2. Hallman, W., C. Cuite, N. Hooker, 

‘‘Consumer Responses to Food Recalls: 2009 

National Survey Report,’’ Publication no. RR– 

0109–018, New Brunswick, NJ: Rutgers, the 

State University of New Jersey, Food Policy 

Institute, 2009. 

3. Acheson, D., ‘‘Outbreak of Escherichia 

coli 0157 Infections Associated With Fresh 

Spinach—United States, August-September 

2006,’’ 2007 (http://first.fda.gov/cafdas/ 

documents/Acheson_Spinach_

Outbreak_2006_FDA_pres.ppt). 

Dated: April 28, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10357 Filed 5–3–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0184] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Experimental 

Study of Patient Information 

Prototypes 

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 for 

research entitled ‘‘Experimental Study of 

Patient Information Prototypes.’’ This 

study is designed to determine based on 

different prototype testing whether 

consumers are able to comprehend 

serious warnings, directions for use, 

drug indications and uses, 

contraindications, and side effects in the 

material that is presented. 

DATES: Submit written or electronic 

comments on the collection of 

information by July 6, 2010. 

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: 

Elizabeth Berbakos, Office of 

Management Programs (HFA–250), Food 

and Drug Administration, 1350 Piccard 

Dr., PI50–400B, Rockville, MD 20850 

301–796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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 Patient 

Information Prototypes—New 

In order to make informed decisions 

about health care and to use their 

medications correctly, consumers need 

easy access to up-to-date and accurate 

information about the risks, benefits and 

safe use of their prescription drugs. 

Consumers currently receive multiple 

pieces of paper with their prescription 

drugs from the pharmacy, containing 

information that is developed and 

distributed through various sources. 

Written prescription drug information is 

provided through a voluntary effort 

(Consumer Medication Information)1 as 

well as through FDA mandated use of 

Medication Guides2 and Patient Package 

Inserts (PPI).3 Patients describe a wide 

range of experiences and varying 

degrees of satisfaction with information 

currently provided at the time 

medicines are received at the pharmacy. 

In some cases, the written documents 

are difficult to read and understand, 

duplicative and overlapping, 

incomplete or contradictory. FDA has 

held multiple public meetings to solicit 

feedback on providing balanced, 

comprehensive and up-to-date 

prescription drug information to 

consumers. 

Since 1968, FDA regulations have 

required that PPIs written specifically 

for patients be distributed when certain 

prescription drugs or classes of 

prescription drugs are dispensed. PPIs 

are required for estrogens and oral 

contraceptives, are considered part of 

the product labeling, and are to be 

dispensed to the patient with the 

product. In the 1970s, FDA began 

evaluating the general usefulness of 

patient labeling for prescription drugs 

resulting in a series of regulatory steps 

to help ensure the availability of useful 

written consumer information. Other 

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23776 Federal Register / Vol. 75, No. 85 / Tuesday, May 4, 2010 / Notices 

4Aikin, K.J., ‘‘Consumer Comprehension and 

Preference for Variations in the Proposed Over-TheCounter Drug Labeling Format, Final Report’’ 

(1998); Vigilante, W.J., M.S. Wogalter, ‘‘The 

Preferred Order of Over-the-Counter (OTC) 

Pharmaceutical Label Components,’’ Drug 

Information Journal, 31, 973–988, 1997. 

5Levy, A.S., S.B. Fein, R.E. Schucker. ‘‘More 

Effective Nutrition Label Formats Are Not 

Necessarily More Preferred.’’ Journal of the 

American Dietetic Association, 92(10), 1230–1234, 

1992. 6Lorch, R., E. Lorch, ‘‘Effects of Organizational 

Signals on Text-Processing Strategies,’’ Journal of 

Educational Psychology, 87(4), 537–544, 1995; 

Lorch, R., E. Lorch, ‘‘Effects of Organizational 

Signals on Free Recall of Expository Text,’’ Journal 

of Educational Psychology, 88(1), 38–48, 1996; 

Lorch, R., E. Lorch, W. Inman, ‘‘Effects of Signaling 

Topic Structure on Text Recall,’’ Journal of 

Educational Psychology, 85(2), 281–290, 1993. 

7Wood, R., A. Bandura, ‘‘Impact of Conceptions 

of Ability on Self-regulatory Mechanisms and 

Complex Decision Making.’’ Journal of Personality 

and Social Psychology, 56(3), 407–415, 1989. 

8Lorch, R., E. Lorch, ‘‘Effects of Organizational 

Signals on Text-processing Strategies, ’’ Journal of 

Educational Psychology, 87(4), 537–544, 1995; 

Lorch, R., E. Lorch, ‘‘Effects of Organizational 

Signals on Free Recall of Expository Text,’’ Journal 

of Educational Psychology, 88(1), 38–48, 1996; 

Lorch, R., E. Lorch, W. Inman, ‘‘Effects of Signaling 

Topic Structure on Text Recall,’’ Journal of 

Educational Psychology, 85(2), 281–290, 1993. 

PPIs are submitted to FDA voluntarily 

by manufacturers and approved by FDA, 

but their distribution is not mandated 

by regulation. In the Federal Register of 

July 6, 1979 (44 FR 40016), FDA 

proposed regulations that would have 

required written patient information for 

all prescription drugs. In the Federal 

Register of September 12, 1980 (45 FR 

60754), FDA finalized those regulations. 

In the Federal Register of September 7, 

1982 (47 FR 39147), the regulations 

were revoked based, in part, on 

assurances that the effort could be 

handled more efficiently within the 

private sector. 

In the Federal Register of August 24, 

1995 (60 FR 44182), FDA proposed the 

Prescription Drug Product Labeling: 

Medication Guide Requirements, 

designed to set specific distribution and 

quality goals and timeframes for 

distributing written information to 

patients. In the Federal Register of 

December 1, 1998 (63 FR 66378 at 

66396), the agency published a final 

rule that established a program under 

which Medication Guides would be 

required for a small number of drugs 

considered to pose a serious and 

significant public health concern (21 

CFR 208.20). 

Evidence suggests that both the 

content (e.g., organization) and format 

(e.g., white space) of a document will 

impact the comprehension of patient 

information. Research on reading 

behavior and document simplification 

suggests that the use of less complex 

terminology presented in shorter 

sentences with a more organized, or 

chunked, structure should improve 

consumer processing for at least three 

reasons. First, it should decrease the 

cognitive load engendered by the 

current physician-directed format. 

Second, a more structured and 

organized patient information document 

should present a less imposing 

processing demand, increasing 

consumers’ willingness and selfperceived ability to read and understand 

the presented material. Research with 

the format of over-the-counter (OTC) 

drug labels,4 the nutrition facts label,5

and other information formats6

demonstrates that information presented 

with section headings, graphics (such as 

bullets), and other design elements is 

more easily read than information 

presented in paragraph format. 

Consumers are more likely to engage in 

behavior they believe they can 

successfully complete.7 Third, a patient 

information document that provides 

readers with clearer ‘‘signals’’ regarding 

the most important information should 

help readers prioritize the importance of 

the presented information. This should 

increase the probability that the set of 

information identified as important is 

subjected to more complete mental 

processing, thereby increasing the 

communication of that information.8

As part of FDA’s efforts to improve 

the patient information received with 

prescription drugs, a Risk 

Communications Advisory Committee 

meeting was held on February 26 and 

27, 2009. At this meeting, committee 

members discussed issues such as the 

ones described previously in this 

document and listened to stakeholder 

problems regarding the design and 

distribution of patient information. 

Following the advisory committee 

meeting, the working group created four 

prototypes to aid discussion at a public 

workshop to be held later in the year. 

This public workshop was held on 

September 24 and 25, 2009. During the 

workshop stakeholders from industry, 

consumer advocacy, and academia 

converged to discuss desirable features 

for a single-document patient leaflet, if 

that were to be developed, consumer 

tested and distributed. Participants were 

divided into six groups to address the 

pros and cons of the four prototypes 

with the goal of deciding which features 

participants appreciated and did not 

appreciate. Additional information on 

the September 24 and 25, 2009, public 

workshop, is available at http:// 

www.fda.gov/Drugs/NewsEvents/ 

ucm168106.htm. 

Given the information obtained from 

workshop participants, the working 

group refined several prototypes and 

designed a study to investigate the 

usefulness of three possible patient 

information formats from a user 

perspective. The results of this study 

will inform FDA as to the usefulness 

and parameters of various format 

options for the patient information 

documents. 

II. Description of the Project 

This project is designed to test 

different ways of presenting information 

about prescription drugs to patients who 

have obtained a prescription. The 

information used will be based on a 

fictitious medication for the treatment of 

rheumatoid arthritis, ankylosing 

spondylitis, and plaque psoriasis. Data 

collection will occur via computer at 

training and testing facilities with 

orientation and debriefing conducted by 

interviewers. Participants will include 

adults who have been diagnosed with 

one of the conditions the fictitious drug 

treats. Participants will be prescreened 

to obtain a reasonable representation of 

health literacy, including those who 

score at the lower end of the scale. 

Questionnaire measures will include 

open- and closed-ended questions. 

Extensive pretesting of materials and 

stimuli will be conducted to refine the 

experimental stimuli and dependent 

measures and to ensure the stimuli meet 

minimum communication requirements 

and are delivering expected messages. 

Proposed Study Design and Protocol 

The study is experimental and will 

have two independent variables in a 3 

x 2 design. The independent variables 

are Format (3 levels: Drug Facts, 

Minimal Column, and Column Plus) 

and Order (2 levels: Warning first and 

Indication first). 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 75, No. 85 / Tuesday, May 4, 2010 / Notices 23777 

9Cotunga N., C.E. Vickery, K.M. CarpenterHaefele, ‘‘Evaluation of Literacy Level of Patient 

Education Pages in Health-Related Journals,’’ 

Journal of Community Health, 30(3), 213–219, 2005. 

10Andrus, M.R., M.T. Roth, ‘‘Health Literacy: A 

Review,’’ Pharmacotherapy, 22(3), 282–302, 2002. 

FORMAT

Order Drug Facts Minimal Column Column Plus 

Warning first 

Indication first 

The Order manipulation will vary the 

primacy of the boxed warning 

information versus the paragraph about 

the uses to the drug. In terms of Format, 

the Drug Facts format will follow the 

conventions of the existing OTC 

labeling. The Minimal Column 

condition will contain information in 

two columns with only basic 

information in the sections regarding 

information patients should tell their 

doctors. The Column Plus condition 

will also present information in two 

columns, but will include additional 

contextual information in the sections 

about what information patients should 

report to their doctors. 

Participants with relevant medical 

conditions will be randomly assigned to 

one of the six experimental conditions 

and each participant will see only one 

version of the patient information. 

Participants will be prescreened to 

represent a range of health literacy 

levels, including a portion with low 

literacy. Thus, all participants in the 

study will have been diagnosed with 

rheumatoid arthritis, ankylosing 

spondylitis, or plaque psoriasis and at 

least 30 percent of the sample will fall 

in the lower range of literacy. Because 

the average reading level in the United 

States is estimated to be 8th grade9 and 

it is recommended that consumer 

medication information be written at a 

5th grade reading level,10 the low 

literate cohort will consist of consumers 

who have 5th to 8th grade reading skills. 

Education level is not a reliable 

substitute for literacy testing. At 

screening, the participants will be 

assessed for literacy level using a 

validated instrument. 

An additional small study will be 

conducted via the Internet to determine 

whether electronic prototype 

presentation alters the processing of the 

information in any way. Two-hundred 

individuals with the same 

characteristics of the original sample 

(e.g., medical condition and literacy 

levels) will be recruited over the 

Internet and will complete the same 

questionnaire as original participants. 

FDA is undertaking this study 

because it does not yet have sufficient 

evidence-based research relating to 

patient needs, or whether those needs 

are being effectively met. Research 

related to the functionality and 

effectiveness of written patient 

information consistently identifies the 

importance of performance-based 

testing as well as content based testing, 

which enables the evaluation of 

materials in order to assure their utility 

and identify issues in content format, or 

design. Development of new 

prescription drug patient materials must 

be based on consumer testing that 

focuses on utility to the patient and 

comprehension of material in the 

broadest audience possible. FDA has 

developed three prototypes in order to 

user test prescription drug information 

with consumers in order to achieve this 

goal. For further information, contact 

Elizabeth Berbakos (see FOR FURTHER

INFORMATION CONTACT). 

The burden table reflects up to three 

pretests of 180 individuals each, 900 

participants in the main study, and 200 

participants in the followup study 

involving electronic administration. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section No. of Respondents Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

540 1 540 20/60 178 

900 1 900 25/60 369 

200 1 200 25/60 82 

Total 629 

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

Dated: April 28, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10359 Filed 5–3–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0190] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Infant Formula 

Requirements 

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, including each proposed 

extension of an existing collection of 

mstockstill on DSKH9S0YB1PROD with NOTICES