[Federal Register Volume 73, Number 165 (Monday, August 25, 2008)]
[Notices]
[Pages 50030-50031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-19653]


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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 [email protected]. 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