[Federal Register: January 9, 2006 (Volume 71, Number 5)]
[Notices]
[Page 1428-1429]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ja06-33]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0508]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Survey of Healthcare Practitioners Regarding Their
Preferences for Public Health Notifications
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,
and to allow 60 days for public comment in response to the notice. This
notice solicits comments on a survey of healthcare practitioners'
preferences regarding public health notifications (PHNs).
DATES: Submit written or electronic comments on the collection of
information by March 10, 2006.
ADDRESSES: Submit electronic comments on the collection of information
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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, 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, 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 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.
Survey of Healthcare Practitioners Regarding Their Preferences for PHNs
The PHN is one of the tools that the Center for Devices and
Radiological Health (CDRH) uses to get an important message to the user
community about risks associated with use of medical devices. This
particular tool is meant to serve a specific purpose not served by the
other communication tools at our disposal--to be a source of
information for healthcare practitioners, immediately recognizable as a
statement from FDA, about a device risk with information on how to
avoid or mitigate the risk. The purpose of this project is to evaluate
the current notification format and distribution process for CDRH, with
the goal of determining what is necessary to assure that the
notifications reach, and are acted upon by, the target audience. The
center needs to know that it is using the most effective approach to
formatting and to disseminating PHNs to assure that they are received,
recognized, understood, and acted upon quickly and effectively by
medical practitioners and institutions. Considerations include, but are
not limited to, design, terminology, nomenclature, distribution,
utility of standardization, relationship with other medical product
notifications (e.g., recalls), use of electronic transmission, and use
of plain language.
The intent of this project is to determine the preferences of the
healthcare community for learning from FDA about risks associated with
medical devices and to compare the current process against the approach
identified by the research to be ``preferred'' with the intent of
improving our format and process.
CDRH will conduct a survey of a sample of healthcare providers who
receive a new PHN from FDA. Most recently, FDA has been using
intermediary organizations, such as professional associations, to help
us distribute notifications to the appropriate target audiences and we
are
[[Page 1429]]
assuming that any new PHN will be disseminated in this way, using the
appropriate association to distribute the PHN to their members.
Generally, the PHN is distributed to the target audience
electronically, either as a link embedded in a news article or sent
directly via e-mail from either the professional association or FDA
using the e-mail listing provided by the professional association. As
part of the notification, we will provide a link to a Web-based
questionnaire that will collect information related to the healthcare
providers' preferences for learning about risks associated with medical
devices.
The information collected in this survey will help FDA identify the
most effective format(s) and distribution method(s) for CDRH PHNs.
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 per Total Annual Hours per
Activity Respondents Response Responses Response Total Hours
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Survey of healthcare providers in relevant specialty 300 1 300 .1666 50
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Survey of healthcare providers in another relevant 300 1 300 .1666 50
specialty
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Total 100
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Public reporting burden for this collection of information is
estimated to average 10 minutes per response, including the time for
reviewing instructions and completing the questionnaire.
Dated: January 3, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-72 Filed 1-6-06; 8:45 am]
BILLING CODE 4160-01-S