[Federal Register: August 25, 2008 (Volume 73, Number 165)]
[Notices]
[Page 50030-50031]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au08-58]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-N-0087] (formerly Docket No. 2007N-0461)
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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
September 24, 2008.
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 baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-NEW and title,
``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.'' Also include the FDA docket
number found in brackets in the heading of this document.
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.
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 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 an ``expert model'' of the same decision-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 an
expert 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 24 to 30 members of each of 2 categories of
health care providers (described in the following paragraph) who
provide health care services to pregnant and 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 primary care practitioners.
(2) Selected specialties of healthcare providers who directly care
for women of reproductive age who have chronic health conditions
(allergists, psychiatrists, neurologists, and cardiologists).
In the Federal Register of December 11, 2007 (72 FR 70328), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 50031]]
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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60 1 1 1.0 60.0
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\1\ There are no capital costs or operating and maintenance costs for this information collection.
The study will involve about 60 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 six health care providers.
These resulted in the current protocol.
Dated: August 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-19653 Filed 8-22-08; 8:45 am]
BILLING CODE 4160-01-S