[Federal Register Volume 75, Number 85 (Tuesday, May 4, 2010)]
[Pages 23775-23777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10359]



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 

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, 
[email protected].


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 Guides\2\ 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.

    \1\ Public Law 104-180, August 6, 1996, Title VI. Effective 
Medication Guides.
    \2\ 21 CFR part 208.
    \3\ 21 CFR 310.501 and 310.515.

    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

[[Page 23776]]

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 self-perceived 
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 formats\6\ 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 

    \4\ Aikin, K.J., ``Consumer Comprehension and Preference for 
Variations in the Proposed Over-The-Counter 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.
    \5\ Levy, 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, 
    \6\ Lorch, 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.
    \7\ Wood, 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.
    \8\ Lorch, 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.

    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).

[[Page 23777]]

          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 grade\9\ 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 

    \9\ Cotunga N., C.E. Vickery, K.M. Carpenter-Haefele, 
``Evaluation of Literacy Level of Patient Education Pages in Health-
Related Journals,'' Journal of Community Health, 30(3), 213-219, 
    \10\ Andrus, M.R., M.T. Roth, ``Health Literacy: A Review,'' 
Pharmacotherapy, 22(3), 282-302, 2002.

    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 
    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 

                                 Table 1.--Estimated Annual Reporting Burden \1\
   21 CFR                          Annual Frequency      Total Annual          Hours per
   Section    No. of Respondents     per Response          Responses           Response           Total Hours
                             540                   1                 540               20/60                 178
                             900                   1                 900               25/60                 369
                             200                   1                 200               25/60                  82
Total                                                                                                        629
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    Dated: April 28, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.

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