[Federal Register Volume 73, Number 227 (Monday, November 24, 2008)]
[Notices]
[Pages 71006-71007]
From the Federal Register Online via the Government Publishing 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 http://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 http://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