[Federal Register: December 11, 2007 (Volume 72, Number 237)]
[Notices]
[Page 70328-70329]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11de07-49]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0461]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Mental Models Study of Communicating With Health Care
Providers About the Risks and Benefits of Prescription Drug Use for
Pregnant and Nursing Women With Chronic Conditions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 Communicating With Health Care Providers
About the Risks and Benefits of Prescription Drug Use for Pregnant and
Nursing Women With Chronic Conditions. Together with other information
being collected, the results from this study will be used to help
inform FDA about how health care providers use prescription drug
labeling and other available information in making treatment decisions
and how that use differs from how agency experts believe such
information is used. It will also contribute to FDA's ability to plan
internal and external communications activities that address any
misperceptions and gaps in understanding about prescription drug
labeling.
DATES: Submit written or electronic comments on the collection of
information by February 11, 2008.
ADDRESSES: Submit electronic comments on the collection of information
to: http://www.fda.gov/dockets/ecomments. 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: Jonna Capezutto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
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: (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 Communicating With Health Care Providers About
the Risks and Benefits of Prescription Drug Use for Pregnant and
Nursing Women With Chronic Conditions
The authority for FDA to collect the information derives from the
FDA Commissioner's authority, as specified in section 903(d)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)).
The proposed information collection will help FDA advance public
health by identifying misperceptions and knowledge gaps about how
health care providers use information to make decisions about the use
of prescription drugs for the targeted patient groups. Knowledge of
these misperceptions and gaps provides opportunities for FDA to target
its communications more precisely to such gaps and areas of
misperception in health care providers' mental models regarding
treatment decisions.
FDA engages in various 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 CFR Sec. 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 data collection and analysis is
designed to identify knowledge gaps that FDA could then address, which
would ultimately improve decision making and potentially improve health
outcomes.
The project will use ``mental modeling,'' a qualitative research
method that compares a model of the decision-making processes of a
group or groups to a model of the same decision-
[[Page 70329]]
making processes developed from expert knowledge and experience. In
this study, the decision models of certain health care providers
concerning treatment options for pregnant and nursing women will be
compared to a decision model concerning such treatment options that was
derived from the knowledge and experience of FDA reviewers responsible
for product labeling. FDA will use telephone interviews to determine
from the health care providers the factors that influence their
treatment decisions for pregnant and nursing women with chronic
conditions. 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 or information campaigns
designed by FDA.
Using a protocol derived from the research that resulted in the
``expert model,'' trained interviewers will conduct one-on-one
telephone discussions with about 25 members of 2 categories of health
care providers (described below) who provide health care services to
pregnant or nursing women.
The two categories of health care providers are:
(1) Those who directly care for pregnant and nursing women,
including obstetricians, OB/GYNs (obstetrician/gynecologists), nurse
midwives, and general practitioners.
(2) Those who directly care for women of reproductive age with
significant chronic health conditions (e.g., allergists, psychiatrists,
or cardiologists).
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency Total Annual Hours per
No. of Respondents per Response Responses Response Total Hours
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54 1 1 1.0 54.0
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Total ................. ................. ................. 54.0
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The study will involve about 54 respondents and take approximately
1 hour each to complete. These estimates are based on the contractor's
extensive experience with mental models research. FDA conducted
pretests of the mental models protocol with three health care
providers. These resulted in the current protocol.
Dated: December 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-23976 Filed 12-10-07; 8:45 am]
BILLING CODE 4160-01-S