[Federal Register Volume 72, Number 138 (Thursday, July 19, 2007)]
[Notices]
[Pages 39628-39629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14015]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0283]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; FDA Survey of 
Physicians' Perceptions of the Impact of Early Risk Communication About 
Medical Products

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 August 
20, 2007.

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, ``FDA Survey of Physicians' Perceptions of the Impact of Early 
Risk Communication about Medical Products.'' Also include the FDA 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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.

FDA Survey of Physicians' Perceptions of the Impact of Early Risk 
Communication about Medical Products (OMB Control Number 0910-NEW)

    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)).
    FDA engages in a number of communication activities to inform 
health care providers about new risks of regulated medical products, 
including prescription drugs, biologics, and medical devices (for 
example, pacemakers, implantable cardiac defibrillators, contact 
lenses, infusion pumps). More recently, FDA's communication activities 
have also included the general public. Activities include, but are not 
limited to, communications in medical journals, through the press 
(press releases, public health advisories), letters to health care 
providers sent out in cooperation with product manufacturers, and 
notifications and information sheets about recalls, withdrawals, and 
new product safety information on FDA's Internet site.
    Extensive publicity regarding serious side effects from certain 
commonly used prescription drugs, as well as certain implantable 
medical devices, has spurred public pressure to make risk information 
available sooner. In opposition to such public pressures, however, at 
least some prescribers and medical societies have suggested that early 
disclosure of potential side effects (emerging risks) may have 
unintended negative effects on patient care. For FDA to plan informed 
programmatic communication activities we need better empirical data 
about the impact of disseminating emerging risk information on 
providers and patient care. In addition, only limited research 
addresses specific barriers to physicians reporting patient adverse 
events either to FDA or product manufacturers. Further, we have no data 
evaluating FDA's efforts to improve reporting.
    Given differing perspectives on the value and timing of providing 
risk information to medical experts and the public at large, FDA 
believes it is important to assess how well it is communicating with 
physicians--the health care provider group with primary responsibility 
for deciding whether to use medical products to address patient 
problems. This information is critical both to plan programmatic 
communication activities and to improve the effectiveness of our 
reporting systems. Therefore, FDA plans to conduct a survey of a 
nationally representative group of physicians about these issues.
    The survey will collect information from respondents through 
computer-assisted telephone interviews conducted by experienced 
interviewers. FDA expects to have a final sample of 900 physicians, 
broken down approximately half and half between primary care 
practitioners (general practice, family practice, general internal 
medicine, and pediatricians) and specialists. The physician specialty 
groups identified for inclusion in the survey are office-based 
allergists, dermatologists, endocrinologists, nephrologists, certain 
oncologists, ophthalmologists, certain surgeons, psychiatrists, 
pulmonologists and rheumatologists. These groups were chosen to provide 
a reasonable cross-section of specialists who use both drugs and 
medical devices that might have been the focus of relatively recent 
publicity concerning emerging risk information. Procedures will be used 
to ensure production of a sample of physicians that is reasonably 
representative of the population within the United States. The design 
of the interview questions will be guided by the results of a series of 
6 physician focus groups. The interview will take approximately 15 
minutes to administer.
    Key information to be collected includes the following topics:

[[Page 39629]]

    1. The impact on physicians, their patients, and their practices of 
the disclosure of still uncertain, emerging risks associated with 
medical products.
    2. How physicians currently receive and ideally would like to 
receive new risk information about medical products (for example, at 
what level of certainty regarding causality and through what 
communication channels).
    3. How physicians perceive the trustworthiness of FDA and other 
potential sources of risk information, including product sponsors, 
medical societies, and the media.
    4. What FDA might do to increase the likelihood that respondents 
will report to FDA or to manufacturers serious patient reactions that 
might be side effects of using medical products.
    In the Federal Register of July 31, 2006 (71 FR 43200), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. Comments were received from five public entities 
consisting of two corporations and three associations. Comments 
supported FDA's belief in the value of conducting the survey. None of 
the comments addressed specific survey questions. FDA agrees with the 
comments concerning the study methodology.
     Questions should be clear and not leading or ambiguous.
     FDA should conduct pre-tests.
     The sample size will be sufficient to provide 
statistically relevant information for the two stratified segments of 
physicians and the combination of these segments.
    After carefully considering them, FDA determined that other 
comments would require changes that would reduce the utility of study 
results by diluting the study's focus, omitting important topic areas, 
or making the questionnaire excessively long and thereby reducing 
response rates. These comments included the following:
     Including other health care providers ``who prescribe 
drugs.''
     Getting more detail about particular source categories.
     Omitting questions about how respondents report adverse 
events or product problems.
    FDA agreed with the value of adding some questions that ask about 
the inclusion of other information, including benefits, in 
communications about newly emerging product risks.
    FDA also received feedback from experts in the fields of risk 
communication and health literacy on the study and the proposed 
questionnaire at an ``Effective Risk Communication'' Think Tank 
Workshop. FDA revised the survey questionnaire in response to this 
feedback, the feedback received through the public comments, and eight 
cognitive interviews conducted in May 2007.

                                 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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27 (Pretests)                                         1                 27                 .3                8.1
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1,000 (Screener)                                      1              1,000               .025               25.0
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900 (Survey)                                          1                900                .25              225.0
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Total                                 .................  .................  .................              258.1
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    These estimates are based on FDA's and the contractor's experience 
with previous surveys. The respondents are divided into two groups: 
Primary care physicians and specialist physicians. We are basing this 
estimate on 90 percent of the screened physicians being eligible to 
participate in the survey.
    Prior to administering the survey with the entire sample, FDA plans 
to conduct pretests with up to 27 physicians; these are meant to 
evaluate the clarity and consistency of the survey questionnaire and 
interview protocol.

    Dated: July 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-14015 Filed 7-18-07; 8:45 am]
BILLING CODE 4160-01-S