Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Healthcare Practitioners Regarding Their Preferences for Public Health Notifications, 1428-1429 [E6-72]
Download as PDF
<![CDATA[
1428
Federal Register / Vol. 71, No. 5 / Monday, January 9, 2006 / Notices
CALENDAR OF REPORTING DATES FOR CALIFORNIA SPECIAL ELECTION—Continued
Close of
books 1
Report
Post-Runoff & July Quarterly 3 .....................................................................................................
06/30/06
Reg./Cert. &
overnight
mailing date
Filing date
07/15/06
07/15/06 2
05/22/06
07/15/06
05/25/06
07/15/06 2
Committees Involved Only In The Special Runoff (06/06/06) Must File:
Pre-Runoff ....................................................................................................................................
Post-Runoff & July Quarterly 3 .....................................................................................................
05/17/06
06/30/06
1 The period begins with the close of books of the last report filed by the committee. If the committee has filed no previous reports, the period
begins with the date of the committee’s first activity.
2 Notice that this deadline falls on a holiday or a weekend. Filing dates are not extended when they fall on nonworking days.
3 Committees should file a consolidated Post-Runoff and July Quarterly Report by the filing date of the July Quarterly Report.
Dated: December 29, 2005.
Scott E. Thomas,
Chairman, Federal Election Commission.
[FR Doc. E6–42 Filed 1–6–06; 8:45 am]
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.
BILLING CODE 6715–01–P
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.
cprice-sewell on PROD1PC66 with NOTICES
ACTION:
Notice.
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: https://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
VerDate Aug<31>2005
15:31 Jan 06, 2006
Jkt 208001
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.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
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
E:\FR\FM\09JAN1.SGM
09JAN1
1429
Federal Register / Vol. 71, No. 5 / Monday, January 9, 2006 / Notices
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 BURDEN1
No. of
Respondents
Activity
Annual Frequency per
Response
Total Annual
Responses
Hours per
Response
Total Hours
Survey of healthcare providers in
relevant specialty
300
1
300
.1666
50
Survey of healthcare providers in
another relevant specialty
300
1
300
.1666
50
Total
100
1There
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0507]
Agency Emergency Processing Under
Office of Management and Budget
Review; Guidance on Informed
Consent for In Vitro Diagnostic Device
Studies Using Leftover Human
Specimens That are Not Individually
Identifiable
AGENCY:
Food and Drug Administration,
HHS.
cprice-sewell on PROD1PC66 with NOTICES
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 emergency processing under
the Paperwork Reduction Act of 1995
(the PRA). FDA believes, and is
preparing a guidance document
explaining, that it is possible in certain
circumstances for In Vitro Diagnostic
(IVD) device studies to be conducted
using leftover specimens obtained
without informed consent while
protecting the human subjects who are
VerDate Aug<31>2005
15:31 Jan 06, 2006
Jkt 208001
the source of such specimens. This
notice solicits comments on the
proposed collection of information
associated with the guidance document
entitled ‘‘Guidance on Informed
Consent for In Vitro Diagnostic Device
Studies Using Leftover Human
Specimens that are Not Individually
Identifiable.’’
DATES: Fax written comments on the
collection of information by February 8,
2006. FDA is requesting approval of this
emergency processing by January 17,
2006.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. 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: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Information
Resources Management (HFA–250),
Food and Drug Administration, 5600
Fishers Lane, rm. 16B–26, Rockville,
MD 20857, 301–827–1472.
SUPPLEMENTARY INFORMATION: FDA has
requested emergency processing of this
proposed collection of information
under section 3507(j) of the PRA (44
U.S.C. 3507(j)) and 5 CFR 1320.13. The
Center for Devices and Radiological
Health (CDRH) intends to issue a
guidance document that addresses an
immediate need of the research
community. CDRH’s guidance will
identify the circumstances when the
agency intends to exercise enforcement
discretion regarding the informed
consent requirements. These
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
requirements normally apply to all
FDA-regulated clinical studies,
including studies using only leftover
human specimens that are not
individually identifiable. The agency
intends to issue this guidance because
the existing requirements are bringing a
halt to a class of very valuable research
that can produce new diagnostic tests,
without appreciably adding protection
for human subjects.
With respect to the following
proposed collection of information, FDA
invites comments on the following
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.
Guidance on Informed Consent for In
Vitro Diagnostic Device Studies Using
Leftover Human Specimens That are
Not Individually Identifiable
FDA’s investigational device
regulations are intended to encourage
the development of new, useful devices
in a manner that is consistent with
public health, safety, and with ethical
standards. Investigators should have
freedom to pursue the least burdensome
means of accomplishing this goal.
However, to ensure that the balance is
maintained between product
E:\FR\FM\09JAN1.SGM
09JAN1
]]>Agencies
[Federal Register Volume 71, Number 5 (Monday, January 9, 2006)]
[Notices]
[Pages 1428-1429]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-72]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours per
Activity Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Survey of healthcare providers in relevant specialty 300 1 300 .1666 50
--------------------------------------------------------------------------------------------------------------------------------------------------------
Survey of healthcare providers in another relevant 300 1 300 .1666 50
specialty
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
