[Federal Register Volume 71, Number 59 (Tuesday, March 28, 2006)]
[Notices]
[Pages 15420-15421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-4440]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0508]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Survey of Health Care 
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 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 April 
27, 2006.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Survey of Health Care Practitioners Regarding Their Preferences for 
Public Health Notifications (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 the use of medical devices. This 
particular tool is meant to serve a specific purpose not served by the 
other communication tools at our

[[Page 15421]]

disposal--to be a source of information for health care 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 
health care 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 health care 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 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 health care 
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.
    In the Federal Register of January 9, 2006 (71 FR 1428), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                       Activity                            Respondents         per Response          Responses           Response         Total Hours
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Survey of health care providers in relevant specialty                 300                     1                300              .1666                 50
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Survey of health care 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: March 22, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-4440 Filed 3-27-06; 8:45 am]
BILLING CODE 4160-01-S