Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mental Models Study of Health Care Providers' Understanding of Prescription Drug Effectiveness, 15293-15295 [E9-7471]
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Federal Register / Vol. 74, No. 63 / Friday, April 3, 2009 / Notices
manufacture, distribution, dispensing,
possession, or use of a controlled
substance is prohibited in the grantee’s
workplace and specifying the actions
that will be taken against employees for
violation of such prohibition;
(2) Establishing an ongoing drug-free
awareness program to inform employees
about—
(a) The dangers of drug abuse in the
workplace;
(b) The grantee’s policy of
maintaining a drug-free workplace;
(c) Any available drug counseling,
rehabilitation, and employee assistance
programs; and
(d) The penalties that may be imposed
upon employees for drug abuse
violations occurring in the workplace;
(3) Making it a requirement that each
employee to be engaged in the
performance of the grant be given a copy
of the statement required by paragraph
(a);
(4) Notifying the employee in the
statement required by paragraph (a) that,
as a condition of employment under the
grant, the employee will—
(a) Abide by the terms of the
statement; and
(b) Notify the employer in writing of
his or her conviction for a violation of
a criminal drug statute occurring in the
workplace no later than five calendar
days after such conviction;
(5) Notifying the agency in writing,
within 10 calendar days after receiving
notice under paragraph (d)(2) from an
employee or otherwise receiving actual
notice of such conviction. Employers of
convicted employees must provide
notice, including position title, to every
grant officer or other designee on whose
grant activity the convicted employee
was working, unless the Federal agency
has designated a central point for the
receipt of such notices. Notice shall
include the identification number(s) of
each affected grant;
(6) Taking one of the following
actions, within 30 calendar days of
receiving notice under paragraph (d)(2),
with respect to any employee who is so
convicted—
(a) Taking appropriate personnel
action against such an employee, up to
and including termination, consistent
with the requirements of the
Rehabilitation Act of 1973, as amended;
or
(b) Requiring such employee to
participate satisfactorily in a drug abuse
assistance or rehabilitation program
approved for such purposes by a
Federal, State, or local health, law
enforcement, or other appropriate
agency;
(7) Making a good faith effort to
continue to maintain a drug-free
VerDate Nov<24>2008
16:07 Apr 02, 2009
Jkt 217001
workplace through implementation of
paragraphs (a), (b), (c), (d), (e) and (f).
The grantee may insert in the space
provided below the site(s) for the
performance of work done in
connection with the specific grant:
Place of Performance (Street address,
city, county, state, zip code)
llllllllllllllllll
l
llllllllllllllllll
l
Check if there are workplaces on file
that are not identified here.
Alternate II. (Grantees Who Are
Individuals)
(1) The grantee certifies that, as a
condition of the grant, he or she will not
engage in the unlawful manufacture,
distribution, dispensing, possession, or
use of a controlled substance in
conducting any activity with the grant;
(2) If convicted of a criminal drug
offense resulting from a violation
occurring during the conduct of any
grant activity, he or she will report the
conviction, in writing, within 10
calendar days of the conviction, to every
grant officer or other designee, unless
the Federal agency designates a central
point for the receipt of such notices.
When notice is made to such a central
point, it shall include the identification
number(s) of each affected grant.
[FR Doc. E9–7502 Filed 4–2–09; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0589]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Mental Models
Study of Health Care Providers’
Understanding of Prescription Drug
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 4,
2009.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
15293
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Mental Models Study of Health
Care Providers’ Understanding of
Prescription Drug Effectiveness.’’ Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–796–3792.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Mental Models Study of Health Care
Providers’ Understanding of
Prescription Drug Effectiveness
The Federal Food, Drug, and Cosmetic
Act (the act) requires that
manufacturers, packers, and distributors
(sponsors) who advertise prescription
human and animal drugs, including
biological products for humans, disclose
in advertisements certain information
about the advertised product’s uses and
risks.1 By its nature, the presentation of
this risk information is likely to evoke
active trade-offs by consumers and
physicians, i.e., comparisons with the
perceived risks of not taking a
treatment, and comparisons with the
perceived benefits of taking a
treatment.2 The FDA has an interest in
fostering safe and proper use of
prescription drugs, which is an activity
that necessitates understanding of both
risks and benefits. Thus, an indepth
understanding of physicians’ processing
of this information, their thinking on
relevant topics, and their informational
needs are central to this regulatory task.
Under the act, FDA engages in a
variety of communication activities to
ensure that patients and health care
providers have the information they
need to make informed decisions about
treatment options, including the use of
prescription drugs. FDA regulations (21
1 For prescription drugs and biologics, the act
requires advertisements to contain ‘‘information in
brief summary relating to side effects,
contraindications, and effectiveness’’ (21 U.S.C.
352(n)).
2 See Swartz, L., Woloshin, S., Black, W., and
Welch, H.G., ‘‘The role of numeracy in
understanding the benefit of screening
mammography,’’Annals of Internal Medicine,
127(11), 966–72, 1997.
E:\FR\FM\03APN1.SGM
03APN1
sroberts on PROD1PC70 with NOTICES
15294
Federal Register / Vol. 74, No. 63 / Friday, April 3, 2009 / Notices
CFR 201.57) describe the content of
required product labeling, and FDA
reviewers ensure that labeling contains
accurate and complete information
about the known risks and benefits of
each drug.
This proposed data collection will
provide FDA with insight for evaluating
and improving current communication
procedures. It is designed to identify
knowledge gaps for FDA to address,
which would ultimately improve
practitioner decisionmaking and hence
the health outcomes of the affected
patients. This new information
collection uses ‘‘Mental Modeling,’’
which is a qualitative research method
that compares a model of the
decisionmaking processes of a group or
groups to a model of the same process
developed from expert knowledge and
experience. In this study, the decision
models of health care providers
concerning their understanding of drug
product efficacy and how they
communicate their understanding to
their patients will be compared to a
model derived from the knowledge and
experience of experts who review
product labeling for the purpose of
ensuring that prescribers get the
information they need to make optimal
prescribing decisions. FDA will use
telephone interviews to determine from
the health care providers the factors that
influence their understanding of drug
product efficacy and how they
communicate their understanding to
their patients. Comparing expert and
health care provider responses will
allow for a richer understanding of
decisions determining drug product
efficacy from labeling and other sources
and how this understanding is
communicated to their patients.
FDA regulations require that
prescription drug advertisements that
make (promotional) claims about a
product also include risk information in
a ‘‘balanced’’ manner (21 CFR
202.1(e)(5)(ii)), both in terms of the
content and presentation of the
information. This balance applies to
both the front display page of an
advertisement and the brief summary
page. However, beyond the ‘‘balance’’
requirement there is limited guidance
and research to direct or encourage
sponsors to present benefit claims that
are informative, specific, and reflect
clinical effectiveness data.
Research and guidance to sponsors on
how to present benefit and efficacy
information in prescription drug
advertisements is limited. For example,
‘‘benefit claims,’’ broadly defined,
appearing in advertisements are often
presented in general language that does
not inform patients of the likelihood of
VerDate Nov<24>2008
16:07 Apr 02, 2009
Jkt 217001
efficacy and are often simply variants of
an ‘‘intended use’’ statement.3 In a
study involving a content analysis of
direct-to-consumer (DTC) advertising,
the researchers classified the
‘‘promotional techniques’’ used in the
advertisements. Emotional appeals were
observed in 67 percent of the ads while
vague and qualitative benefit
terminology was found in 87 percent of
the ads. Only 9 percent contained data.
However, for risk information, half the
advertisements used data to describe
side-effects, typically with lists of sideeffects that generally occurred
infrequently.
Additional research is necessary to
uncover important information about
how consumers understand
effectiveness information about
prescription drug products from DTC
advertisements. This particular
understanding is crucial to the riskbenefit tradeoff that patients must make
with the consultation of a health care
professional in order to achieve the best
health outcomes. The qualitative
information in this Mental Models
phase of the research will provide a
preliminary framework and help FDA
craft subsequent quantitative studies.
Overview. The proposed information
collection will use ‘‘mental modeling,’’
a qualitative research method wherein
the decisionmaking processes of a group
of physician respondents concerning the
effectiveness of various prescription
drug products are modeled and
compared to a model based on expert
labeling knowledge and clinical
experience in drug effectiveness. The
information will be collected by
telephone interviews concerning the
factors that influence perceptions and
decisions related to drug effectiveness.
This method will help identify
physicians’ beliefs, priorities,
informational needs, visions and
conceptualizations about how well
particular drugs work. A comparison
between expert and physician models
based on the collected information may
identify ‘‘consequential knowledge
gaps’’ that can be redressed through
labeling changes as well as helping FDA
focus future quantitative research on the
communication of drug benefit
information. Thus, the information to be
collected will be used by FDA to
develop and strengthen research
materials and design in future planned
quantitative experiments.
The first step in the mental models
process is to conduct background
3 Woloshin, S. and Schwartz, L., ‘‘Direct to
consumer advertisements for prescription drugs:
what are Americans being told,’’ Lancet, 358, 1141–
46, 2001.
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
research to develop a model based on
both experts’ current knowledge and
extant literature on drug effectiveness.
The resulting ‘‘simple expert model’’ is
a mapping of decisionmaking factors,
relationships and influences, and is
used to develop an interview protocol
for a day-long workshop with experts,
hereafter referred to as the ‘‘expert
elicitation.’’
The expert elicitation was conducted
November 28, 2007. It included nine
experts from a variety of medical fields,
including those versed in drug labeling
issues and others with extensive clinical
experience, particularly involving two
medical conditions (insomnia, a
medical condition frequently treated by
general practitioners, and rheumatoid
arthritis, a condition likely treated by
specialists). Six experts were internal to
FDA, two experts were from the
National Institutes of Health, and one
expert was external to the Federal
Government, from the Association of
Medical Colleges. The expert elicitation
process does not solicit advice,
opinions, or recommendations from the
group, but instead tries to determine
how each expert perceives the factors
related to consumer decisionmaking,
from their particular expert field.
Results from the expert elicitation were
used to develop the expert model,
which generally includes adding new
concepts and supporting details to the
existing simple expert model. The new
draft expert model was validated during
a subsequent teleconference with the
research team about a month following
the initial elicitation. Following the
validation, the project team finalized the
expert model.
The expert model informs the
development of the physician interview
guide for physician telephone
interviews. Mental models research is
typically conducted with cohorts of
respondents who represent categories of
people whose mental models are to be
compared, both individually with the
expert model and between cohorts,
identifying the potential for significant
differences among cohorts. Interviews
will be conducted with 40 health care
providers to develop a mental model
describing how each of 2 cohorts learns
about drug product efficacy and how
their understanding about efficacy is
communicated to their patients. The
cohorts are as follows:
(1) Primary care providers. This
cohort includes office-based
practitioners in primary care (general
practice, family practice, and internal
medicine) with at least 3 years of
experience and who engage in patient
care at least 50 percent of the time.
E:\FR\FM\03APN1.SGM
03APN1
15295
Federal Register / Vol. 74, No. 63 / Friday, April 3, 2009 / Notices
(2) Specialists. This cohort includes
office-based practitioners in
rheumatology with at least 3 years of
experience and who engage in patient
care at least 50 percent of the time.
Cohorts will be identified and
recruited to represent a reasonable range
of age, gender, and ethnicity.
Within each cohort, 20 practitioners
will be interviewed by trained
interviewers in one-on-one in-depth
telephone interviews. A sample size of
40 (approximately 20 primary care
providers and 20 rheumatologists) is
sufficiently large for the qualitative
findings to capture a wide depth and
range of people’s thinking. The
interviews will take approximately 45
minutes. The health care provider
interviews will be used to create a
mental model of physician
decisionmaking factors with respect to
drug product effectiveness.
Potential physician participants will
be randomly identified through a
purchased list based on the American
Medical Association’s (AMA) Physician
Masterfile. This list tracks all
physicians, M.D. (doctor of medicine)
and DO (doctor of osteopathic
medicine), practicing in the United
States, not only members of the AMA.
FDA intends this collection to be used
as formative research. As with our focus
group research (OMB control number
0910–0360), the results of this formative
research will provide direction toward
potential areas of focus. Further
research is necessary, and planned, to
test concepts obtained from these
results. This research will be useful in
designing survey questions for the next
phases of this research project (which
will be submitted for approval at a later
date).
In the Federal Register of November
24, 2008 (73 FR 71006), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours Per
Response
Total Hours
21 U.S.C. 393(b)(2)(c) Questionnaire, Pretesting
4
1
4
.75
3
21 U.S.C. 393(b)(2)(c) Questionnaire, Study
40
1
40
.75
30
Total
33
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–7471 Filed 4–2–09; 8:45 am]
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0184. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0653]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Filing Objections
and Requests for a Hearing on a
Regulation or Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 4,
2009.
sroberts on PROD1PC70 with NOTICES
SUMMARY:
VerDate Nov<24>2008
16:07 Apr 02, 2009
Jkt 217001
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Filing Objections and Requests for a
Hearing on a Regulation or Order—
(OMB Control Number 0910–0184)—
Extension
The regulations in 21 CFR 12.22,
issued under section 701(e)(2) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 371(e)(2)), set forth
the instructions for filing objections and
requests for a hearing on a regulation or
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
order under § 12.20(d) (21 CFR
12.20(d)). Objections and requests must
be submitted within the time specified
in § 12.20(e). Each objection, for which
a hearing has been requested, must be
separately numbered and specify the
provision of the regulation or the
proposed order. In addition, each
objection must include a detailed
description and analysis of the factual
information and any other document,
with some exceptions, supporting the
objection. Failure to include this
information constitutes a waiver of the
right to a hearing on that objection. FDA
uses the description and analysis to
determine whether a hearing request is
justified. The description and analysis
may be used only for the purpose of
determining whether a hearing has been
justified under 21 CFR 12.24 and do not
limit the evidence that may be
presented if a hearing is granted.
Respondents to this information
collection are those parties that may be
adversely affected by an order or
regulation.
In the Federal Register of January 14,
2009 (74 FR 2080), FDA published a 60day notice requesting public comment
on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\03APN1.SGM
03APN1
]]>Agencies
[Federal Register Volume 74, Number 63 (Friday, April 3, 2009)]
[Notices]
[Pages 15293-15295]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-7471]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0589]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Mental Models Study
of Health Care Providers' Understanding of Prescription Drug
Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by May 4,
2009.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-NEW and
title ``Mental Models Study of Health Care Providers' Understanding of
Prescription Drug Effectiveness.'' Also include the FDA docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Mental Models Study of Health Care Providers' Understanding of
Prescription Drug Effectiveness
The Federal Food, Drug, and Cosmetic Act (the act) requires that
manufacturers, packers, and distributors (sponsors) who advertise
prescription human and animal drugs, including biological products for
humans, disclose in advertisements certain information about the
advertised product's uses and risks.\1\ By its nature, the presentation
of this risk information is likely to evoke active trade-offs by
consumers and physicians, i.e., comparisons with the perceived risks of
not taking a treatment, and comparisons with the perceived benefits of
taking a treatment.\2\ The FDA has an interest in fostering safe and
proper use of prescription drugs, which is an activity that
necessitates understanding of both risks and benefits. Thus, an indepth
understanding of physicians' processing of this information, their
thinking on relevant topics, and their informational needs are central
to this regulatory task.
---------------------------------------------------------------------------
\1\ For prescription drugs and biologics, the act requires
advertisements to contain ``information in brief summary relating to
side effects, contraindications, and effectiveness'' (21 U.S.C.
352(n)).
\2\ See Swartz, L., Woloshin, S., Black, W., and Welch, H.G.,
``The role of numeracy in understanding the benefit of screening
mammography,''Annals of Internal Medicine, 127(11), 966-72, 1997.
---------------------------------------------------------------------------
Under the act, FDA engages in a variety of communication activities
to ensure that patients and health care providers have the information
they need to make informed decisions about treatment options, including
the use of prescription drugs. FDA regulations (21
[[Page 15294]]
CFR 201.57) describe the content of required product labeling, and FDA
reviewers ensure that labeling contains accurate and complete
information about the known risks and benefits of each drug.
This proposed data collection will provide FDA with insight for
evaluating and improving current communication procedures. It is
designed to identify knowledge gaps for FDA to address, which would
ultimately improve practitioner decisionmaking and hence the health
outcomes of the affected patients. This new information collection uses
``Mental Modeling,'' which is a qualitative research method that
compares a model of the decisionmaking processes of a group or groups
to a model of the same process developed from expert knowledge and
experience. In this study, the decision models of health care providers
concerning their understanding of drug product efficacy and how they
communicate their understanding to their patients will be compared to a
model derived from the knowledge and experience of experts who review
product labeling for the purpose of ensuring that prescribers get the
information they need to make optimal prescribing decisions. FDA will
use telephone interviews to determine from the health care providers
the factors that influence their understanding of drug product efficacy
and how they communicate their understanding to their patients.
Comparing expert and health care provider responses will allow for a
richer understanding of decisions determining drug product efficacy
from labeling and other sources and how this understanding is
communicated to their patients.
FDA regulations require that prescription drug advertisements that
make (promotional) claims about a product also include risk information
in a ``balanced'' manner (21 CFR 202.1(e)(5)(ii)), both in terms of the
content and presentation of the information. This balance applies to
both the front display page of an advertisement and the brief summary
page. However, beyond the ``balance'' requirement there is limited
guidance and research to direct or encourage sponsors to present
benefit claims that are informative, specific, and reflect clinical
effectiveness data.
Research and guidance to sponsors on how to present benefit and
efficacy information in prescription drug advertisements is limited.
For example, ``benefit claims,'' broadly defined, appearing in
advertisements are often presented in general language that does not
inform patients of the likelihood of efficacy and are often simply
variants of an ``intended use'' statement.\3\ In a study involving a
content analysis of direct-to-consumer (DTC) advertising, the
researchers classified the ``promotional techniques'' used in the
advertisements. Emotional appeals were observed in 67 percent of the
ads while vague and qualitative benefit terminology was found in 87
percent of the ads. Only 9 percent contained data. However, for risk
information, half the advertisements used data to describe side-
effects, typically with lists of side-effects that generally occurred
infrequently.
---------------------------------------------------------------------------
\3\ Woloshin, S. and Schwartz, L., ``Direct to consumer
advertisements for prescription drugs: what are Americans being
told,'' Lancet, 358, 1141-46, 2001.
---------------------------------------------------------------------------
Additional research is necessary to uncover important information
about how consumers understand effectiveness information about
prescription drug products from DTC advertisements. This particular
understanding is crucial to the risk-benefit tradeoff that patients
must make with the consultation of a health care professional in order
to achieve the best health outcomes. The qualitative information in
this Mental Models phase of the research will provide a preliminary
framework and help FDA craft subsequent quantitative studies.
Overview. The proposed information collection will use ``mental
modeling,'' a qualitative research method wherein the decisionmaking
processes of a group of physician respondents concerning the
effectiveness of various prescription drug products are modeled and
compared to a model based on expert labeling knowledge and clinical
experience in drug effectiveness. The information will be collected by
telephone interviews concerning the factors that influence perceptions
and decisions related to drug effectiveness. This method will help
identify physicians' beliefs, priorities, informational needs, visions
and conceptualizations about how well particular drugs work. A
comparison between expert and physician models based on the collected
information may identify ``consequential knowledge gaps'' that can be
redressed through labeling changes as well as helping FDA focus future
quantitative research on the communication of drug benefit information.
Thus, the information to be collected will be used by FDA to develop
and strengthen research materials and design in future planned
quantitative experiments.
The first step in the mental models process is to conduct
background research to develop a model based on both experts' current
knowledge and extant literature on drug effectiveness. The resulting
``simple expert model'' is a mapping of decisionmaking factors,
relationships and influences, and is used to develop an interview
protocol for a day-long workshop with experts, hereafter referred to as
the ``expert elicitation.''
The expert elicitation was conducted November 28, 2007. It included
nine experts from a variety of medical fields, including those versed
in drug labeling issues and others with extensive clinical experience,
particularly involving two medical conditions (insomnia, a medical
condition frequently treated by general practitioners, and rheumatoid
arthritis, a condition likely treated by specialists). Six experts were
internal to FDA, two experts were from the National Institutes of
Health, and one expert was external to the Federal Government, from the
Association of Medical Colleges. The expert elicitation process does
not solicit advice, opinions, or recommendations from the group, but
instead tries to determine how each expert perceives the factors
related to consumer decisionmaking, from their particular expert field.
Results from the expert elicitation were used to develop the expert
model, which generally includes adding new concepts and supporting
details to the existing simple expert model. The new draft expert model
was validated during a subsequent teleconference with the research team
about a month following the initial elicitation. Following the
validation, the project team finalized the expert model.
The expert model informs the development of the physician interview
guide for physician telephone interviews. Mental models research is
typically conducted with cohorts of respondents who represent
categories of people whose mental models are to be compared, both
individually with the expert model and between cohorts, identifying the
potential for significant differences among cohorts. Interviews will be
conducted with 40 health care providers to develop a mental model
describing how each of 2 cohorts learns about drug product efficacy and
how their understanding about efficacy is communicated to their
patients. The cohorts are as follows:
(1) Primary care providers. This cohort includes office-based
practitioners in primary care (general practice, family practice, and
internal medicine) with at least 3 years of experience and who engage
in patient care at least 50 percent of the time.
[[Page 15295]]
(2) Specialists. This cohort includes office-based practitioners in
rheumatology with at least 3 years of experience and who engage in
patient care at least 50 percent of the time.
Cohorts will be identified and recruited to represent a reasonable
range of age, gender, and ethnicity.
Within each cohort, 20 practitioners will be interviewed by trained
interviewers in one-on-one in-depth telephone interviews. A sample size
of 40 (approximately 20 primary care providers and 20 rheumatologists)
is sufficiently large for the qualitative findings to capture a wide
depth and range of people's thinking. The interviews will take
approximately 45 minutes. The health care provider interviews will be
used to create a mental model of physician decisionmaking factors with
respect to drug product effectiveness.
Potential physician participants will be randomly identified
through a purchased list based on the American Medical Association's
(AMA) Physician Masterfile. This list tracks all physicians, M.D.
(doctor of medicine) and DO (doctor of osteopathic medicine),
practicing in the United States, not only members of the AMA.
FDA intends this collection to be used as formative research. As
with our focus group research (OMB control number 0910-0360), the
results of this formative research will provide direction toward
potential areas of focus. Further research is necessary, and planned,
to test concepts obtained from these results. This research will be
useful in designing survey questions for the next phases of this
research project (which will be submitted for approval at a later
date).
In the Federal Register of November 24, 2008 (73 FR 71006), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Table 1--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency per Total Annual Hours Per
21 CFR Section Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 U.S.C. 393(b)(2)(c) Questionnaire, Pretesting 4 1 4 .75 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 U.S.C. 393(b)(2)(c) Questionnaire, Study 40 1 40 .75 30
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total ................. ....................... ................. ................. 33
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-7471 Filed 4-2-09; 8:45 am]
BILLING CODE 4160-01-S
