[Federal Register Volume 70, Number 245 (Thursday, December 22, 2005)]
[Notices]
[Pages 76054-76056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-7642]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0486]


Agency Information Collection Activities; Proposed Collection; 
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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[[Page 76055]]

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, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on FDA Public Health Notification 
(formerly known as Safety Alert/Public Health Advisory) Readership 
Survey.

DATES: Submit written or electronic comments on the collection of 
information by February 21, 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, Room 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, including 
each proposed extension of an existing 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.

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.
    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.


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    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, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5-7642 Filed 12-21-05; 8:45 am]
BILLING CODE 4160-01-S