[Federal Register Volume 71, Number 146 (Monday, July 31, 2006)]
[Notices]
[Pages 43200-43202]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-12159]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0283]


Agency Information Collection Activities; Proposed Collection; 
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 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 a 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 a proposed survey of physicians' 
perceptions of the impact of early risk communication about medical 
products. The purpose of the proposed survey is to improve FDA's 
understanding of how and when physicians get, and would like to get, 
information about the risk of medical products, and what factors might 
influence the likelihood of reporting their patients' adverse 
experiences. Together with other information, the data from this survey 
will be used to assess FDA's communication efforts concerning early 
risk communication about medical products, and inform any potential 
communication-related changes.

DATES: Submit written or electronic comments on the collection of 
information by September 29, 2006.

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 Capezzuto, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

[[Page 43201]]


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.

FDA Survey of Physicians' Perceptions of the Impact of Early Risk 
Communication About Medical Products

    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 895 physicians, 
broken down approximately half and half between primary care 
practitioners (general practice, family practice, general internal 
medicine, and pediatricians) and specialists. We expect to identify 
physician specialty groups that are most likely to have been affected 
by recent publicity over risks of prescription drugs or medical 
devices. Such groups may include neurologists, psychiatrists, 
cardiologists, gastroenterologists, dermatologists, allergists, 
urologists, obstetricians/gynecologists, and geriatricians. 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 physician focus groups that have recently been completed. 
The interview will take approximately 15 minutes to administer.
    Key information to be collected includes the following topics:
     The impact on physicians, their patients, and their 
practices of the disclosure of still uncertain, emerging risks 
associated with medical products.
     How physicians currently receive and ideally would like to 
receive new risk and benefit information about medical products (for 
example, at what level of certainty regarding causality and through 
what communication channels).
     How physicians perceive the credibility of FDA and other 
potential sources of risk and benefit information, including product 
sponsors, medical societies, and the media.
     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.
    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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27 (Pretests)                                      1                    27                .25               6.75
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995 (Screener)                                     1                   995               .025              24.88
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895 (Survey)                                       1                   895                .25             223.75
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[[Page 43202]]

 
Total                              .................  ....................  .................             255.38
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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 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-12159 Filed 7-28-06; 8:45 am]
BILLING CODE 4160-01-S