Agency Information Collection Activities; Proposed Collection; Comment Request; Mental Models Study of Health Care Providers' Understanding of Prescription Drug Effectiveness, 71006-71007 [E8-27801]
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Federal Register / Vol. 73, No. 227 / Monday, November 24, 2008 / Notices
implementation services to Indian
Tribes regarding the title IV–E program.
In order to plan for the review of
Tribal title IV–E plans and technical
assistance needs, the Administration for
Children and Families (ACF) is
requesting that all Federally recognized
Indian Tribes, Tribal organizations or
Tribal consortia (hereafter, ‘‘Tribes’’)
that plan to operate a title IV–E program
send a letter of intent to their ACF
Regional Program Manager by December
31, 2008.
ACF will ask Tribes to include in the
letter of intent the following
information:
1. The Federal fiscal year (FY) in
which the Tribe expects to begin
operation of a title IV–E program.
(According to the law, the earliest
possible implementation period is FY
2010.)
2. Information on the intended Tribal
service area for the Tribal title IV–E
program.
Respondents: Indian Tribes, Tribal
organizations and Tribal consortia.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Information collection
Letter of Intent .................................................................................................
Estimated Total Annual Burden
Hours: 562.
Additional Information: ACF is
requesting that OMB grant a 90-day
approval for this information collection
under procedures for emergency
processing by November 28, 2008. A
copy of this information collection, with
applicable supporting documentation,
may be obtained by calling the
Administration for Children and
Families, Reports Clearance Officer,
Robert Sargis at (202) 690–7275 or emailing to infocollection@acf.hhs.gov.
Comments and questions about the
information collection described above
should be directed to the Office of
Information and Regulatory Affairs,
Attn: OMB Desk Officer for ACF, Office
of Management and Budget, Paperwork
Reduction Project, 725 17th Street, NW.,
Washington, DC 20503, (202) 395–7316.
Dated: November 13, 2008.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. E8–27668 Filed 11–21–08; 8:45 am]
BILLING CODE 4184–01–M
Food and Drug Administration
[Docket No. FDA–2008–N–0589]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Mental Models
Study of Health Care Providers’
Understanding of Prescription Drug
Effectiveness
AGENCY:
Food and Drug Administration,
sroberts on PROD1PC70 with NOTICES
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
VerDate Aug<31>2005
19:32 Nov 21, 2008
Jkt 217001
562
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection provisions of
the Mental Models Study of Health Care
Providers’ Understanding of
Prescription Drug Effectiveness.
Together with other information being
collected, the results from this study
will be used to help inform FDA about
how health care providers conceptualize
the drug effectiveness portion of the
risk/benefit tradeoff and how that
conceptualization differs from how
agency experts think about drug
effectiveness. The information gathered
in this study will be used to focus and
strengthen future planned quantitative
research. It will also contribute to FDA’s
ability to communicate drug
effectiveness information to health care
providers in labeling and other
communications.
Submit written or electronic
comments on the collection of
information by January 23, 2009.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–796–3792.
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
Average
burden hours
per response
Total burden
hours
1
562
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
Mental Models Study of Health Care
Providers’ Understanding of
Prescription Drug Effectiveness
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.
E:\FR\FM\24NON1.SGM
24NON1
71007
Federal Register / Vol. 73, No. 227 / Monday, November 24, 2008 / Notices
Section 903(b)(2)(c) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 393(b)(2)(c)) authorizes FDA to
conduct research relating to drugs and
other FDA regulated products in
carrying out the provisions of the act.
FDA regulations require that an
advertisement that makes claims about
a prescription drug include a ‘‘air
balance’’ of information about the
benefits and risks of the advertised
product, in terms of both content and
presentation (21 CFR 202.1(e)(5)(ii)). In
past research, FDA has focused
primarily on the risk component of the
risk/benefit ratio. In the interest of
thoroughly exploring the issue of fair
balance, however, the presentation of
effectiveness, or benefit, information is
equally important. This component has
received less scrutiny. The proposed
information collection described here is
the first step in a three-phase study
designed to investigate the role of
effectiveness information in
prescription drug print advertising.
Along the way, we plan to investigate
how health care providers use labeling
and other materials and experiences to
reach conclusions about drug
effectiveness. We will use this
information to provide a benchmark
with which to compare the information
consumers receive from direct-toconsumer advertisements.
The information collection described
here refers only to the qualitative
portion of the study series, Phase I. The
purpose of the proposed information
collection is twofold. First, we plan to
gather information in this phase that
will help us to determine the proper
concepts about which to inquire and the
proper language to use when asking
health care providers in the second
phase about the effectiveness of certain
drug products. Second, we will use the
information gathered in this phase to
identify gaps in the communication of
effectiveness information in FDA
sponsored materials, such as the
physician labeling.
The proposed information collection
described here (Phase I of a multi-phase
project) will use ‘‘mental modeling,’’ a
qualitative research method that
compares a model of the
decisionmaking processes of a group or
groups to a model of the same
decisionmaking processes developed
from expert knowledge and experience.
In this study, the decision models of
certain health care providers concerning
effectiveness decisions of various
treatment options for individuals
suffering from insomnia or rheumatoid
arthritis will be compared to a decision
model concerning drug effectiveness
that was derived from the knowledge
and experience of FDA reviewers
responsible for product labeling,
National Institutes of Health clinical
experts in this field, and others involved
in the training of medical professionals.
FDA will use telephone interviews to
determine from the health care
providers the factors that shape their
understanding and decisions about the
effectiveness of various drug treatments
for their patients. A comparison
between expert and health care provider
models based on the collected
information may identify consequential
knowledge gaps that can be redressed
through messages designed by FDA and
will provide information for designing
the second (quantitative) phase of
research with a national sample of
health care providers.
Using a protocol derived from the
research that resulted in the expert
model, trained interviewers will
conduct one-on-one telephone
discussions with about 20 members of 2
categories of health care providers,
general practitioners and
rheumatologists, who provide direct
patient care at least 50 percent of the
time.
FDA has selected these two groups of
physicians because the first group is
reasonably likely to treat insomnia,
whereas the second group treats
rheumatoid arthritis. We selected these
two medical conditions for focus in the
next two phases of the research because
prescription drug treatments for both are
heavily advertised to consumers, drugs
for these conditions are variable in their
risk/benefit profiles, and yet they are
each fairly complex in terms of risk/
benefit profiles. Another function of the
current information collection is to
determine the feasibility of using these
two medical conditions in the following
quantitative phases.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Annual Frequency
per Response
40
Total Annual
Responses
1
Hours Per
Response
1
Total Hours
0.75
Total
sroberts on PROD1PC70 with NOTICES
1 There
30.0
30.0
are no capital costs or operating and maintenance costs associated with this collection of information.
The study will involve about 40
respondents and take approximately 45
minutes each to complete. These
estimates are based on the contractor’s
extensive experience with mental
models research.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
VerDate Aug<31>2005
19:32 Nov 21, 2008
Jkt 217001
Dated: November 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–27801 Filed 11–21–08; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–N–0474] (formerly
Docket No. 2007N–0292)
George Kindness; Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the act) permanently
debarring Mr. George Kindness from
Frm 00055
Fmt 4703
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]]>Agencies
[Federal Register Volume 73, Number 227 (Monday, November 24, 2008)]
[Notices]
[Pages 71006-71007]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27801]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0589]
Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
the Mental Models Study of Health Care Providers' Understanding of
Prescription Drug Effectiveness. Together with other information being
collected, the results from this study will be used to help inform FDA
about how health care providers conceptualize the drug effectiveness
portion of the risk/benefit tradeoff and how that conceptualization
differs from how agency experts think about drug effectiveness. The
information gathered in this study will be used to focus and strengthen
future planned quantitative research. It will also contribute to FDA's
ability to communicate drug effectiveness information to health care
providers in labeling and other communications.
DATES: Submit written or electronic comments on the collection of
information by January 23, 2009.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Mental Models Study of Health Care Providers' Understanding of
Prescription Drug Effectiveness
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.
[[Page 71007]]
Section 903(b)(2)(c) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 393(b)(2)(c)) authorizes FDA to conduct research
relating to drugs and other FDA regulated products in carrying out the
provisions of the act.
FDA regulations require that an advertisement that makes claims
about a prescription drug include a ``air balance'' of information
about the benefits and risks of the advertised product, in terms of
both content and presentation (21 CFR 202.1(e)(5)(ii)). In past
research, FDA has focused primarily on the risk component of the risk/
benefit ratio. In the interest of thoroughly exploring the issue of
fair balance, however, the presentation of effectiveness, or benefit,
information is equally important. This component has received less
scrutiny. The proposed information collection described here is the
first step in a three-phase study designed to investigate the role of
effectiveness information in prescription drug print advertising. Along
the way, we plan to investigate how health care providers use labeling
and other materials and experiences to reach conclusions about drug
effectiveness. We will use this information to provide a benchmark with
which to compare the information consumers receive from direct-to-
consumer advertisements.
The information collection described here refers only to the
qualitative portion of the study series, Phase I. The purpose of the
proposed information collection is twofold. First, we plan to gather
information in this phase that will help us to determine the proper
concepts about which to inquire and the proper language to use when
asking health care providers in the second phase about the
effectiveness of certain drug products. Second, we will use the
information gathered in this phase to identify gaps in the
communication of effectiveness information in FDA sponsored materials,
such as the physician labeling.
The proposed information collection described here (Phase I of a
multi-phase project) will use ``mental modeling,'' a qualitative
research method that compares a model of the decisionmaking processes
of a group or groups to a model of the same decisionmaking processes
developed from expert knowledge and experience. In this study, the
decision models of certain health care providers concerning
effectiveness decisions of various treatment options for individuals
suffering from insomnia or rheumatoid arthritis will be compared to a
decision model concerning drug effectiveness that was derived from the
knowledge and experience of FDA reviewers responsible for product
labeling, National Institutes of Health clinical experts in this field,
and others involved in the training of medical professionals. FDA will
use telephone interviews to determine from the health care providers
the factors that shape their understanding and decisions about the
effectiveness of various drug treatments for their patients. A
comparison between expert and health care provider models based on the
collected information may identify consequential knowledge gaps that
can be redressed through messages designed by FDA and will provide
information for designing the second (quantitative) phase of research
with a national sample of health care providers.
Using a protocol derived from the research that resulted in the
expert model, trained interviewers will conduct one-on-one telephone
discussions with about 20 members of 2 categories of health care
providers, general practitioners and rheumatologists, who provide
direct patient care at least 50 percent of the time.
FDA has selected these two groups of physicians because the first
group is reasonably likely to treat insomnia, whereas the second group
treats rheumatoid arthritis. We selected these two medical conditions
for focus in the next two phases of the research because prescription
drug treatments for both are heavily advertised to consumers, drugs for
these conditions are variable in their risk/benefit profiles, and yet
they are each fairly complex in terms of risk/benefit profiles. Another
function of the current information collection is to determine the
feasibility of using these two medical conditions in the following
quantitative phases.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual Frequency Hours Per
No. of Respondents per Response Total Annual Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
40 1 1 0.75 30.0
----------------------------------------------------------------------------------------------------------------
Total ................. ....................... ................. 30.0
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The study will involve about 40 respondents and take approximately
45 minutes each to complete. These estimates are based on the
contractor's extensive experience with mental models research.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
Dated: November 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-27801 Filed 11-21-08; 8:45 am]
BILLING CODE 4160-01-S
