
[Federal Register: November 2, 2009 (Volume 74, Number 210)]
[Notices]               
[Page 56642-56643]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02no09-60]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0360]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food and Drug 
Administration Public Health Notification Readership Survey (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 
December 2, 2009.

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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0341. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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 Readership Survey (formerly known as 
Safety Alert/Public Health Advisory Readership Survey) (PHS Act, 
Section 1701(a)(4)); (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. 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: (1) CDRH's understanding of the problem, 
its cause(s), and the scope of the risk that is still evolving, so that 
in order to minimize the risk, the center believes that health care 
practitioners needs the information they can provide, however 
incomplete, as soon as possible and (2) the problem is actively being 
investigated by the center, private 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 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

[[Page 56643]]

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 risks are explained, the timeliness 
of the information, and whether the reader has taken any action to 
eliminate or reduce risk as a result of the 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 and format, and method of dissemination.
    In the Federal Register of August 24, 2009 (74 FR 42674), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    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     Total Annual        Hours per
     PHS Act          Respondents        per Response        Responses           Response         Total Hours
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Section                          308                  3                924                .17                157
 1701(a)(4)
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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: October 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26307 Filed 10-30-09; 8:45 am]

BILLING CODE 4160-01-S
