Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Patient Information Prototypes, 78252-78256 [2010-31388]
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78252
Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices
Dated: December 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–31381 Filed 12–14–10; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0418]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Institutional
Review Boards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 January 14,
2011.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
SUMMARY:
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0130. 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, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850,. 301–
796–3792.
Elizabeth.Berbakos@fda.hhs.gov.
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.
Institutional Review Boards—OMB
Control Number 0910–0130—Extension
When reviewing clinical research
studies regulated by FDA, institutional
review boards (IRBs) are required to
create and maintain records describing
their operations, and make the records
available for FDA inspection when
requested. These records include:
Written procedures describing the
structure and membership of the IRB
and the methods that the IRB will use
in performing its functions; the research
protocols, informed consent documents,
progress reports, and reports of injuries
to subjects submitted by investigators to
the IRB; minutes of meetings showing
attendance, votes and decisions made
by the IRB, the number of votes on each
decision for, against, and abstaining, the
basis for requiring changes in or
disapproving research; records of
continuing review activities; copies of
all correspondence between
investigators and the IRB; statement of
significant new findings provided to
subjects of the research; and a list of IRB
members by name, showing each
member’s earned degrees, representative
capacity, and experience in sufficient
detail to describe each member’s
contributions to the IRB’s deliberations,
and any employment relationship
between each member and the IRB’s
institution. This information is used by
FDA in conducting audit inspections of
IRBs to determine whether IRBs and
clinical investigators are providing
adequate protections to human subjects
participating in clinical research.
In the Federal Register of August 17,
2010 (75 FR 50766), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received regarding the information
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Annual
frequency per
recordkeeping
Total annual
records
Hours per
recordkeeper
Total hours
56.115 ........................................................................
2,500
14.6
36,500
100
3,650,000
Total ....................................................................
..........................
..........................
..........................
..........................
3,650,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
hsrobinson on DSK69SOYB1PROD with NOTICES
The recordkeeping requirement
burden is based on the following: The
burden for each of the paragraphs under
21 CFR 56.115 has been considered as
one estimated burden. FDA estimates
that there are approximately 2,500 IRBs.
The IRBs meet on an average of 14.6
times annually. The agency estimates
that approximately 100 hours of persontime per meeting are required to meet
the requirements of the regulation.
Dated: December 8, 2010.
Leslie Kux,
Acting Assistant, Commissioner for Policy.
Food and Drug Administration
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
[Docket No. FDA–2010–N–0184]
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental
Study of Patient Information
Prototypes
AGENCY:
Food and Drug Administration,
HHS.
Notice.
[FR Doc. 2010–31389 Filed 12–14–10; 8:45 am]
ACTION:
BILLING CODE P
SUMMARY:
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The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
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Fax written comments on the
collection of information by January 14,
2011.
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:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–new and
title ‘‘Experimental Study of Patient
Information Prototypes.’’ Also include
ADDRESSES:
E:\FR\FM\15DEN1.SGM
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Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
792–3792,
Elizabeth.Berbakos@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
hsrobinson on DSK69SOYB1PROD with NOTICES
Experimental Study of Patient
Information Prototypes—(OMB Control
Number 0910–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.
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
1 Public Law 104–180, August 6, 1996, Title VI,
Effective Medication Guides.
2 Part 208 (21 CFR part 208).
3 21 CFR 310.501 and 310.515.
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written consumer information. Other
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, and 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), 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 formats 6
4 Aikin, 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.
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,
1992.
6 Lorch, R., E. Lorch, ‘‘Effects of Organizational
Signals on Text-Processing Strategies,’’ Journal of
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78253
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. For additional information
on the September 24 and 25, 2009,
public workshop, go to https://
www.fda.gov/Drugs/′NewsEvents/
ucm168106.htm.
Given the information obtained from
workshop participants, the working
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.
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Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices
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.
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 3x2
design. The independent variables are
Format (3 levels: Drug Facts, Minimal
Column, and Column Plus) and Order (2
levels: Warning first and Indication
first).
FORMAT
Order
Drug facts
Minimal
column
Column plus
Warning first.
hsrobinson on DSK69SOYB1PROD with NOTICES
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
9 Cotunga 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.
10 Andrus, M.R., M.T. Roth, ‘‘Health Literacy: A
Review,’’ Pharmacotherapy, 22(3), 282–302, 2002.
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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
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Elizabeth Berbakos (see FOR FURTHER
INFORMATION CONTACT).
In the Federal Register of May 4, 2010
(75 FR 23775), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
FDA received five comments. In the
following section, we outline the
observations and suggestions raised in
the comments and provide our
responses. Four of the five comments
expressed support for the conductance
of the research to explore issues of
quantitative benefit information. They
all described the collection of data as a
worthy endeavor which will provide
useful information on how best to
communicate information to patients
about their prescription drugs.
(Comment 1) The first comment stated
that FDA’s approach to examining the
content and format of the prototypes is
reasonable. This comment provided
minor suggestions regarding how to
improve the study, most of which are
currently addressed in the
questionnaire. For example, we have
included time measurement, questions
about the safe use of the product, and
scenario-based questions in the
questionnaire for the second phase of
our study. We have incorporated other
suggestions into the qualitative first
phase of our project. In this phase, we
will present participants with all
versions of the prototypes to assess their
preferences and will able to probe
participants more thoroughly about
their reactions and responses to the
prototypes.
(Comment 2) This comment provided
a statement of support for the approval
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78255
of this data collection, claiming the
study will have practical utility.
(Comment 3) This comment provided
support for the research proposed in
this document and reported that the
components identified by FDA are
consistent with those found in their
own research. The comment suggested
the inclusion of a visual system for
identifying drug products and the
inclusion of a variety of font sizes for
people with visual impairments. FDA
fully supports the presentation of
information for special populations.
However, the scope of the present study
is to determine one format out of several
that works with a range of participants.
After this step, we can move toward
incorporating special features, such as
pictures or large font, to accommodate
patients with varying needs.
(Comment 4) Part of comment 4 was
outside the scope of the proposed data
collection; i.e., regarding the proper
channels for distribution of Patient
Medication Information (PMI).
Regarding the parts of the comment that
focused on the proposed research, the
comment generally discussed omissions
in the current proposed prototypes.
These additional pieces of information
have all been discussed at length at
various public and expert meetings,
including the public workshop in
September 2009, the Brookings Institute
Expert Workshop in July 2010, and the
Part 15 hearing in September 2010.
When improving medication documents
for patients, there is always a trade-off
between the desire to keep it simple and
the desire to provide more information.
Although a small number of individuals
reported the desire for exhaustive
information, the great majority of the
feedback FDA has received and the
literature the Agency has reviewed
suggests that the information in the
currently proposed prototypes is a
reasonable collection of the important
information that patients need to safely
use their medications. Moreover,
research suggests that providing large
amounts of information will not serve
patients well, but may instead impede
their understanding of the
information.11 Finally, the proposed
research itself is designed to address the
issue of whether the information in the
prototypes is optimal. The first phase of
the research will involve qualitative
interviews, wherein participants will
have ample opportunity to tell us what
they want and need to know. The
second phase of the research will
involve quantitative assessment of the
comprehension of important
information in the document. Thus, we
believe our two-pronged approach will
address some of the concerns raised in
this comment and we must defer to the
volumes of other feedback we have
received regarding the limiting of
information in PMI.
(Comment 5) Comment 5 had five
main concerns with the study. First, the
comment suggested that FDA reach out
to Consumer Medication Information
(CMI) publishers as early as possible in
the development of the prototypes. FDA
concurs with the importance of doing
this and, in fact, has already done so
multiple times and in multiple venues.
Several CMI publishers participated in
the public workshop held in September
2009 and spoke at the Part 15 hearing
in September 2010.
Second, the comment claims that FDA
has not used an evidence-based strategy
to develop the PMI prototypes. We
disagree. FDA developed the prototypes
based on the scientific literature. As
described in the first section of this
document, the prototypes were based on
recommendations to include chunks of
information that would reduce cognitive
load and facilitate processing by
including plenty of white space,
headings, and maintaining a readable
font size. From this first step, public
feedback was obtained and
incorporated, and feedback from
communications experts was obtained
and incorporated, resulting in the
current prototypes. At this stage, we are
proposing the continuation of the
gathering of evidence by conducting the
proposed two-part study to examine the
PMI prototypes.
Third, the comment expresses
concerns that the use of a fictitious drug
(and only one) may limit the
generalizability of the findings of the
study. The use of a fictitious drug
eliminates the confound of prior
knowledge when asking participants
about the information they see.
Rheutopia was selected to be a very
close amalgam of an existing class of
drugs. This class was chosen because it
has a complicated set of risks, it is given
by injection (an unusual
administration), and it has multiple
indications. FDA’s reasoning is that if
successful PMI can be developed for
such a complex drug, PMI for drugs
with simpler profiles will be attainable.
It is true we are investigating only one
drug in the current study; this decision
was based on resource constraints. One
research study cannot accomplish all
goals. Future studies may be used to
assess the applicability of the results in
other drug classes.
Fourth, the comment expresses
concern that the research will not
include a variety of different
populations and that the lack of detail
provided in the Federal Register notice
suggests that very little knowledge will
be gained from the research. Regarding
the first part, the revised research
proposed in this document includes low
literacy individuals with chronic
disease, general population individuals,
and individuals with one of the medical
conditions that Rheutopia treats. FDA
believes these are the populations most
relevant to this particular type of drug,
as well as other chronic diseases. In
terms of the detail provided, the
questionnaire, which provided
extensive detail about the exact
questions proposed, was available upon
request during the first comment period
and will continue to be available during
the second comment period.
Fifth and finally, the comment
suggested that comparing variations of a
short, one-page document limits the
findings because there will be no
comparison to a longer document,
which may perform better. FDA
concurs. In the revised research
currently proposed, we have included a
control condition. A subset of
individuals will be randomly assigned
to see the Medication Guide format for
Rheutopia. Thus, we will compare two
proposed one-page prototypes with an
existing document that would be
currently required for Rheutopia if it
were a real drug.
11 See, for example, Day, R.S, PMI: From Concept
to Compliance, Development and Distribution of
Patient Medication Information for Prescription
Drugs: Part 15 Public Hearing, FDA White Oak
Campus, Silver Spring, MD, (September 27, 2010).
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External Reviewers
In addition to public comment, FDA’s
Division of Drug Marketing,
Advertising, and Communications
discussed the prototypes and the
research design and protocol with a
panel of 19 experts convened by the
Brookings Institution on July 21, 2010.
The names of these individuals can be
found in Appendix A. After the
workshop, several experts provided
detailed written feedback to FDA, which
was incorporated into the design of the
study.
FDA estimates the burden of this
collection of information as follows:
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Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual
frequency
per
response
Number of respondents
540 ...................................................................................................
900 ...................................................................................................
200 ...................................................................................................
Total ..........................................................................................
1 There
Dated: December 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0360]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food and Drug
Administration Public Health
Notification Readership Survey
(Formerly Known as the Safety Alert/
Public Health Advisory Readership
Survey)
Food and Drug Administration,
HHS.
Notice.
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 January 14,
2011.
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:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0341. Also
include the FDA docket number found
in brackets in the heading of this
document.
hsrobinson on DSK69SOYB1PROD with NOTICES
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19:10 Dec 14, 2010
Jkt 223001
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850. 301–796–
3793.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
BILLING CODE 4160–01–P
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
[FR Doc. 2010–31388 Filed 12–14–10; 8:45 am]
ACTION:
1
1
1
Hours per
response
540
900
200
20/60
25/60
25/60
Total hours
180
375
83
638
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden chart reflects up to 3
pretests of 180 individuals each, 900
participants in the main study, and 200
participants in the followup study
involving electronic administration.
AGENCY:
Total annual responses
Food and Drug Administration Public
Health Notification Readership Survey
(Formerly Known as the Safety Alert/
Public Health Advisory Readership
Survey)—(OMB Control Number 0910–
0341)—Reinstatement
Section 705(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
375(b)) authorizes FDA to disseminate
information concerning imminent
danger to public health by any regulated
product. The Center for Devices and
Radiological Health (CDRH)
communicates these risks to user
communities through two publications:
(1) The Public Health Notification
(PHN) and (2) the Preliminary Public
Health Notification (PPHN). The PHN is
published when CDRH has information
or a message to convey to health care
practitioners in order for them to make
informed clinical decisions about the
use of a device or device type when that
information may not be readily available
to the affected target audience in the
health care community. CDRH can make
recommendations that will help the
health care practitioner mitigate or
avoid the risk.
The PPHN is also published when
CDRH has information to convey to
health care practitioners in order for
them to make informed clinical
decisions about the use of a device or
device type. However, two additional
conditions exist that make use of this
type of notification preferable: (1)
CDRH’s understanding of the problem,
its cause(s), and the scope of the risk;
the Center believes that health care
practitioners need the information they
can provide, however incomplete, as
soon as possible, and (2) the problem is
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
actively being investigated by the
Center, private industry, another
Agency, or some other reliable entity, so
that the Center expects to be able to
update the PPHN when definitive new
information becomes available.
Notifications are sent to organizations
affected by risks discussed in the
notification, such as hospitals, nursing
homes, hospices, home health care
agencies, retail pharmacies, and other
health care providers. Through a
process for identifying and addressing
postmarket safety issues related to
regulated products, CDRH determines
when to publish notifications.
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.
FDA seeks to evaluate the clarity,
timeliness, and impact of safety alerts
and public health advisories by
surveying a sample of recipients.
Subjects will receive a questionnaire
to be completed and returned to FDA.
The information to be collected will
address how clearly notifications for
reducing risks are explained, the
timeliness of the information, and
whether the reader has taken any action
to eliminate or reduce risks as a result
of the information in the alert. Subjects
will also be asked whether they wish to
receive future notifications
electronically, as well as how the PHN
program might be improved.
The information collected will be
used to shape FDA’s editorial policy for
the PHN and PPHN. Understanding how
target audiences view these publications
will aid in deciding what changes
should be considered in their content
and the format and method of
dissemination.
In the Federal Register of August 24,
2009 (74 FR 42674), FDA published a
60-day notice requesting comments. No
comments were received. However,
FDA is republishing this 30-day notice
for public comment, due to the amount
of time that has passed for submission
of this information collection request to
OMB.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\15DEN1.SGM
15DEN1
]]>Agencies
[Federal Register Volume 75, Number 240 (Wednesday, December 15, 2010)]
[Notices]
[Pages 78252-78256]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31388]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0184]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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 January
14, 2011.
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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-new and
title ``Experimental Study of Patient Information Prototypes.'' Also
include
[[Page 78253]]
the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-792-3792,
Elizabeth.Berbakos@fda.hhs.gov.
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 Study of Patient Information Prototypes--(OMB Control
Number 0910-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\ Part 208 (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 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, and 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), 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
information.\8\
---------------------------------------------------------------------------
\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,
1992.
\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. For
additional information on the September 24 and 25, 2009, public
workshop, go to https://www.fda.gov/Drugs/'NewsEvents/ucm168106.htm.
Given the information obtained from workshop participants, the
working
[[Page 78254]]
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.
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 3x2 design. The independent variables are Format (3 levels: Drug
Facts, Minimal Column, and Column Plus) and Order (2 levels: Warning
first and Indication first).
Format
----------------------------------------------------------------------------------------------------------------
Minimal
Order Drug facts 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
instrument.
---------------------------------------------------------------------------
\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,
2005.
\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
FURTHER INFORMATION CONTACT).
In the Federal Register of May 4, 2010 (75 FR 23775), FDA published
a 60-day notice requesting public comment on the proposed collection of
information. FDA received five comments. In the following section, we
outline the observations and suggestions raised in the comments and
provide our responses. Four of the five comments expressed support for
the conductance of the research to explore issues of quantitative
benefit information. They all described the collection of data as a
worthy endeavor which will provide useful information on how best to
communicate information to patients about their prescription drugs.
(Comment 1) The first comment stated that FDA's approach to
examining the content and format of the prototypes is reasonable. This
comment provided minor suggestions regarding how to improve the study,
most of which are currently addressed in the questionnaire. For
example, we have included time measurement, questions about the safe
use of the product, and scenario-based questions in the questionnaire
for the second phase of our study. We have incorporated other
suggestions into the qualitative first phase of our project. In this
phase, we will present participants with all versions of the prototypes
to assess their preferences and will able to probe participants more
thoroughly about their reactions and responses to the prototypes.
(Comment 2) This comment provided a statement of support for the
approval
[[Page 78255]]
of this data collection, claiming the study will have practical
utility.
(Comment 3) This comment provided support for the research proposed
in this document and reported that the components identified by FDA are
consistent with those found in their own research. The comment
suggested the inclusion of a visual system for identifying drug
products and the inclusion of a variety of font sizes for people with
visual impairments. FDA fully supports the presentation of information
for special populations. However, the scope of the present study is to
determine one format out of several that works with a range of
participants. After this step, we can move toward incorporating special
features, such as pictures or large font, to accommodate patients with
varying needs.
(Comment 4) Part of comment 4 was outside the scope of the proposed
data collection; i.e., regarding the proper channels for distribution
of Patient Medication Information (PMI). Regarding the parts of the
comment that focused on the proposed research, the comment generally
discussed omissions in the current proposed prototypes. These
additional pieces of information have all been discussed at length at
various public and expert meetings, including the public workshop in
September 2009, the Brookings Institute Expert Workshop in July 2010,
and the Part 15 hearing in September 2010. When improving medication
documents for patients, there is always a trade-off between the desire
to keep it simple and the desire to provide more information. Although
a small number of individuals reported the desire for exhaustive
information, the great majority of the feedback FDA has received and
the literature the Agency has reviewed suggests that the information in
the currently proposed prototypes is a reasonable collection of the
important information that patients need to safely use their
medications. Moreover, research suggests that providing large amounts
of information will not serve patients well, but may instead impede
their understanding of the information.\11\ Finally, the proposed
research itself is designed to address the issue of whether the
information in the prototypes is optimal. The first phase of the
research will involve qualitative interviews, wherein participants will
have ample opportunity to tell us what they want and need to know. The
second phase of the research will involve quantitative assessment of
the comprehension of important information in the document. Thus, we
believe our two-pronged approach will address some of the concerns
raised in this comment and we must defer to the volumes of other
feedback we have received regarding the limiting of information in PMI.
---------------------------------------------------------------------------
\11\ See, for example, Day, R.S, PMI: From Concept to
Compliance, Development and Distribution of Patient Medication
Information for Prescription Drugs: Part 15 Public Hearing, FDA
White Oak Campus, Silver Spring, MD, (September 27, 2010).
---------------------------------------------------------------------------
(Comment 5) Comment 5 had five main concerns with the study. First,
the comment suggested that FDA reach out to Consumer Medication
Information (CMI) publishers as early as possible in the development of
the prototypes. FDA concurs with the importance of doing this and, in
fact, has already done so multiple times and in multiple venues.
Several CMI publishers participated in the public workshop held in
September 2009 and spoke at the Part 15 hearing in September 2010.
Second, the comment claims that FDA has not used an evidence-based
strategy to develop the PMI prototypes. We disagree. FDA developed the
prototypes based on the scientific literature. As described in the
first section of this document, the prototypes were based on
recommendations to include chunks of information that would reduce
cognitive load and facilitate processing by including plenty of white
space, headings, and maintaining a readable font size. From this first
step, public feedback was obtained and incorporated, and feedback from
communications experts was obtained and incorporated, resulting in the
current prototypes. At this stage, we are proposing the continuation of
the gathering of evidence by conducting the proposed two-part study to
examine the PMI prototypes.
Third, the comment expresses concerns that the use of a fictitious
drug (and only one) may limit the generalizability of the findings of
the study. The use of a fictitious drug eliminates the confound of
prior knowledge when asking participants about the information they
see. Rheutopia was selected to be a very close amalgam of an existing
class of drugs. This class was chosen because it has a complicated set
of risks, it is given by injection (an unusual administration), and it
has multiple indications. FDA's reasoning is that if successful PMI can
be developed for such a complex drug, PMI for drugs with simpler
profiles will be attainable. It is true we are investigating only one
drug in the current study; this decision was based on resource
constraints. One research study cannot accomplish all goals. Future
studies may be used to assess the applicability of the results in other
drug classes.
Fourth, the comment expresses concern that the research will not
include a variety of different populations and that the lack of detail
provided in the Federal Register notice suggests that very little
knowledge will be gained from the research. Regarding the first part,
the revised research proposed in this document includes low literacy
individuals with chronic disease, general population individuals, and
individuals with one of the medical conditions that Rheutopia treats.
FDA believes these are the populations most relevant to this particular
type of drug, as well as other chronic diseases. In terms of the detail
provided, the questionnaire, which provided extensive detail about the
exact questions proposed, was available upon request during the first
comment period and will continue to be available during the second
comment period.
Fifth and finally, the comment suggested that comparing variations
of a short, one-page document limits the findings because there will be
no comparison to a longer document, which may perform better. FDA
concurs. In the revised research currently proposed, we have included a
control condition. A subset of individuals will be randomly assigned to
see the Medication Guide format for Rheutopia. Thus, we will compare
two proposed one-page prototypes with an existing document that would
be currently required for Rheutopia if it were a real drug.
External Reviewers
In addition to public comment, FDA's Division of Drug Marketing,
Advertising, and Communications discussed the prototypes and the
research design and protocol with a panel of 19 experts convened by the
Brookings Institution on July 21, 2010. The names of these individuals
can be found in Appendix A. After the workshop, several experts
provided detailed written feedback to FDA, which was incorporated into
the design of the study.
FDA estimates the burden of this collection of information as
follows:
[[Page 78256]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
Number of respondents frequency per Total annual Hours per Total hours
response responses response
----------------------------------------------------------------------------------------------------------------
540..................................... 1 540 20/60 180
900..................................... 1 900 25/60 375
200..................................... 1 200 25/60 83
Total............................... 638
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden chart reflects up to 3 pretests of 180 individuals each,
900 participants in the main study, and 200 participants in the
followup study involving electronic administration.
Dated: December 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-31388 Filed 12-14-10; 8:45 am]
BILLING CODE 4160-01-P
