[Federal Register: December 22, 2005 (Volume 70, Number 245)]
[Notices]
[Page 76054-76056]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22de05-60]
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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.
[[Page 76056]]
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