[Federal Register Volume 72, Number 237 (Tuesday, December 11, 2007)]
[Notices]
[Pages 70328-70329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23976]


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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