Document ID: FDA-2009-N-0360-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2009-08-24T04:00Z

[Federal Register: August 24, 2009 (Volume 74, Number 162)]
[Notices]               
[Page 42674-42675]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24au09-67]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; FDA 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 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 
Readership Survey.

DATES: Submit written or electronic comments on the collection of 
information by October 23, 2009.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 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, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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 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

[[Page 42675]]

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 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.
    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: August 17, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20247 Filed 8-21-09; 8:45 am]

BILLING CODE 4160-01-S