[Federal Register Volume 71, Number 141 (Monday, July 24, 2006)]
[Notices]
[Page 41821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-11644]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0486]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food and Drug 
Administration Public Health Notification (formerly known as Safety 
Alert/Public Health Advisory) Readership Survey

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 
23, 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: FDA 
Desk Officer, 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.

FDA Public Health Notification (formerly known as Safety Alert/Public 
Health Advisory) Readership Survey (OMB Control Number 0910-0341)--
Extension.

    Section 705(b) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 375(b)) authorizes FDA to disseminate information 
concerning imminent danger to public health by any regulated product. 
The Center for Devices and Radiological Health (CDRH) communicates 
these risks to user communities through two publications: (1) The 
Public Health Notification (PHN) and (2) the Preliminary Public Health 
Notification (PPHN). The PHN is published when CDRH has information or 
a message to convey to health care practitioners that they would want 
to know in order to make informed clinical decisions about the use of a 
device or device type, and that information may not be readily 
available to the affected target audience in the health care community, 
and CDRH can make recommendations that will help the health care 
practitioner mitigate or avoid the risk.
    The PPHN is also published when CDRH has information to convey to 
health care practitioners that they would want to know in order to make 
informed clinical decisions about the use of a device or device type. 
However, two additional conditions exist that make the use of this type 
of notification preferable. First, CDRH's understanding of the problem, 
its cause(s), and the scope of the risk is still evolving, and in order 
to minimize the risk, the center believes that health care 
practitioners need the information they have, however incomplete, as 
soon as possible. Second, the problem is being actively investigated by 
the center, the industry, another agency, or some other reliable 
entity, so that the center expects to be able to update the PPHN when 
definitive new information becomes available.
    Notifications are sent to organizations affected by the risks 
discussed in the notification, such as hospitals, nursing homes, 
hospices, home health care agencies, retail pharmacies, and other 
health care providers. Through a process for identifying and addressing 
postmarket safety issues related to regulated products, CDRH determines 
when to publish notifications.
    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. FDA seeks to evaluate the clarity, timeliness, and impact 
of safety alerts and public health advisories by surveying a sample of 
recipients. Subjects will receive a questionnaire to be completed and 
returned to FDA. The information to be collected will address how 
clearly notifications for reducing risk are explained, the timeliness 
of the information, and whether the reader has taken any action to 
eliminate or reduce risk as a result of information in the alert. 
Subjects will also be asked whether they wish to receive future 
notifications electronically, as well as how the PHN program might be 
improved.
    The information collected will be used to shape FDA's editorial 
policy for the PHN and PPHN. Understanding how target audiences view 
these publications will aid in deciding what changes should be 
considered in their content, format, and method of dissemination.
    In the Federal Register of December 22,2005 (70 FR 76054), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received in response to that 
notice.
    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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308                                                   3                924                .17                157
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on the history of the PHN program, it is estimated that an 
average of three collections will be conducted a year. The total burden 
of response time is estimated at 10 minutes per survey. This was 
derived by CDRH staff completing the survey and through discussions 
with the contacts in trade organizations.

    Dated: July 17, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-11644 Filed 7-21-06; 8:45 am]
BILLING CODE 4160-01-S