[Federal Register Volume 71, Number 5 (Monday, January 9, 2006)]
[Notices]
[Pages 1428-1429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-72]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0508]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Survey of Healthcare Practitioners Regarding Their 
Preferences for Public Health Notifications

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 a survey of healthcare practitioners' 
preferences regarding public health notifications (PHNs).

DATES: Submit written or electronic comments on the collection of 
information by March 10, 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: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1472.

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.

Survey of Healthcare Practitioners Regarding Their Preferences for PHNs

    The PHN is one of the tools that the Center for Devices and 
Radiological Health (CDRH) uses to get an important message to the user 
community about risks associated with use of medical devices. This 
particular tool is meant to serve a specific purpose not served by the 
other communication tools at our disposal--to be a source of 
information for healthcare practitioners, immediately recognizable as a 
statement from FDA, about a device risk with information on how to 
avoid or mitigate the risk. The purpose of this project is to evaluate 
the current notification format and distribution process for CDRH, with 
the goal of determining what is necessary to assure that the 
notifications reach, and are acted upon by, the target audience. The 
center needs to know that it is using the most effective approach to 
formatting and to disseminating PHNs to assure that they are received, 
recognized, understood, and acted upon quickly and effectively by 
medical practitioners and institutions. Considerations include, but are 
not limited to, design, terminology, nomenclature, distribution, 
utility of standardization, relationship with other medical product 
notifications (e.g., recalls), use of electronic transmission, and use 
of plain language.
    The intent of this project is to determine the preferences of the 
healthcare community for learning from FDA about risks associated with 
medical devices and to compare the current process against the approach 
identified by the research to be ``preferred'' with the intent of 
improving our format and process.
    CDRH will conduct a survey of a sample of healthcare providers who 
receive a new PHN from FDA. Most recently, FDA has been using 
intermediary organizations, such as professional associations, to help 
us distribute notifications to the appropriate target audiences and we 
are

[[Page 1429]]

assuming that any new PHN will be disseminated in this way, using the 
appropriate association to distribute the PHN to their members. 
Generally, the PHN is distributed to the target audience 
electronically, either as a link embedded in a news article or sent 
directly via e-mail from either the professional association or FDA 
using the e-mail listing provided by the professional association. As 
part of the notification, we will provide a link to a Web-based 
questionnaire that will collect information related to the healthcare 
providers' preferences for learning about risks associated with medical 
devices.
    The information collected in this survey will help FDA identify the 
most effective format(s) and distribution method(s) for CDRH PHNs.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of       Annual Frequency per     Total Annual        Hours per
                       Activity                            Respondents            Response           Responses           Response         Total Hours
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Survey of healthcare providers in relevant specialty                  300                     1                300              .1666                 50
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Survey of healthcare providers in another relevant                    300                     1                300              .1666                 50
 specialty
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Total                                                                                                                                                100
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Public reporting burden for this collection of information is 
estimated to average 10 minutes per response, including the time for 
reviewing instructions and completing the questionnaire.

    Dated: January 3, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-72 Filed 1-6-06; 8:45 am]
BILLING CODE 4160-01-S