
[Federal Register Volume 75, Number 240 (Wednesday, December 15, 2010)]
[Notices]
[Pages 78256-78257]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31387]


-----------------------------------------------------------------------

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 the Safety Alert/Public Health Advisory Readership Survey)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 January 
14, 2011.

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: 202-395-7285, 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, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850. 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.

Food and Drug Administration Public Health Notification Readership 
Survey (Formerly Known as the Safety Alert/Public Health Advisory 
Readership Survey)--(OMB Control Number 0910-0341)--Reinstatement

    Section 705(b) of the Federal Food, Drug, and Cosmetic 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 in order for them to make informed 
clinical decisions about the use of a device or device type when 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 in order for them to make informed clinical 
decisions about the use of a device or device type. However, two 
additional conditions exist that make use of this type of notification 
preferable: (1) CDRH's understanding of the problem, its cause(s), and 
the scope of the risk; the Center believes that health care 
practitioners need 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 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 risks 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 the format and method of dissemination.
    In the Federal Register of August 24, 2009 (74 FR 42674), FDA 
published a 60-day notice requesting comments. No comments were 
received. However, FDA is republishing this 30-day notice for public 
comment, due to the amount of time that has passed for submission of 
this information collection request to OMB.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 78257]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Annual
                 Public Health  Service Act section                     Number of      frequency  per    Total annual      Hours per       Total hours
                                                                       respondents        response        responses         response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1701(a)(4).........................................................             308                3              924             0.17              157
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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: December 8, 2010.
Leslie Kux,
Acting Assistant, Commissioner for Policy.
[FR Doc. 2010-31387 Filed 12-14-10; 8:45 am]
BILLING CODE 4160-01-P


