Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey of Health Care Practitioners Regarding Their Preferences for Public Health Notifications, 15420-15421 [E6-4440]
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Federal Register / Vol. 71, No. 59 / Tuesday, March 28, 2006 / Notices
caused or contributed to death or
serious injury or has malfunctioned in
such a way that should the malfunction
recur, it would be likely to cause or
contribute to a death or serious injury.
Device importers report deaths and
serious injuries to the manufacturers
and FDA. Importers report malfunctions
only to the manufacturers, unless they
are unknown, then the reports are sent
to FDA.
The number of respondents for each
CFR section in table 1 of this document
is based upon the number of
respondents entered into FDA’s internal
databases. FDA estimates, based on its
experience and interaction with the
medical device community, that all
reporting CFR sections are expected to
take 1 hour to complete, with the
exception of § 803.19. Section 803.19 is
expected to take approximately 3 hours
to complete, but is only required for
reporting the summarized data quarterly
to FDA. By summarizing events, the
total time used to report for this section
is reduced because the respondents do
not submit a full report for each event
they report in a quarterly summary
report.
The agency believes that the majority
of manufacturers, user facilities, and
importers have already established
written procedures to document
complaints and information to meet the
medical device reporting (MDR)
requirements as part of their internal
quality control system. There are an
estimated 30,000 medical device
distributors. Although they do not
submit MDR reports, they must
maintain records of complaints, under
§ 803.18(d).
The agency has estimated that on
average, 220 user facilities, importers,
and manufacturers would annually be
required to establish new procedures, or
revise existing procedures, in order to
comply with this provision.
Therefore, FDA estimates the onetime burden to respondents for
establishing or revising procedures to be
2,200 hours (220 respondents x 10
hours). For those entities, a one-time
burden of 10 hours is estimated for
establishing written MDR procedures.
The remaining manufacturers, user
facilities, and importers, not required to
revise their written procedures to
comply with this provision, are
excluded from the burden because the
recordkeeping activities needed to
comply with this provision are
considered ‘‘usual and customary’’
under 5 CFR 1320.3(b)(2).
The annual burden for recordkeeping
to respondents follows. Under § 803.17,
FDA estimates 220 respondents will
spend approximately 3.3 hours to
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15:19 Mar 27, 2006
Jkt 208001
complete the requirements for this
section. The number of respondents was
estimated by consolidating the total of
all new reporting entities together. The
3.3 hours was estimated by FDA, as this
section deals with a respondent creating
new MDR procedures and is a one-time
function. The ‘‘total hours’’ for this
section equals approximately 726 hours.
Under § 803.18, 30,000 respondents
represent distributors, importers, and
other respondents to this information
collection. FDA estimates that it should
take them approximately 1 1/2 hours to
complete the recordkeeping requirement
for this section. Total hours for this
section equal 45,000 hours.
Dated: March 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–4426 Filed 3–27–06; 8:45 am]
Dated: March 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–4427 Filed 3–27–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0508]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Survey of Health
Care Practitioners Regarding Their
Preferences for Public Health
Notifications
AGENCY:
ACTION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0118]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Reagents for Detection of
Specific Novel Influenza A Viruses
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Reagents for Detection of
Specific Novel Influenza A Viruses’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Karen Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
An agency
may not conduct or sponsor, and a
person is not required to respond to, a
collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0584. The
approval expires on September 30,
2006. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.fda.gov/ohrms/dockets.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00049
Fmt 4703
Food and Drug Administration,
HHS.
BILLING CODE 4160–01–S
Sfmt 4703
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 review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by April 27,
2006.
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 Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1472.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
ADDRESSES:
Survey of Health Care Practitioners
Regarding Their Preferences for Public
Health Notifications (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 the use of medical
devices. This particular tool is meant to
serve a specific purpose not served by
the other communication tools at our
E:\FR\FM\28MRN1.SGM
28MRN1
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Federal Register / Vol. 71, No. 59 / Tuesday, March 28, 2006 / Notices
disposal—to be a source of information
for health care 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 health
care 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 health care 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
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 health
care 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.
In the Federal Register of January 9,
2006 (71 FR 1428), FDA published a 60day notice requesting public comment
on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Activity
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Survey of health care providers in
relevant specialty
300
1
300
.1666
50
Survey of health care 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: March 22, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–4440 Filed 3–27–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
cprice-sewell on PROD1PC66 with NOTICES
[Docket No. 2001D–0489] (formerly Docket
No. 01D–0489)
Guidance for Clinical Trial Sponsors:
Establishment and Operation of
Clinical Trial Data Monitoring
Committees; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
VerDate Aug<31>2005
15:19 Mar 27, 2006
Jkt 208001
availability of a document entitled
‘‘Guidance for Clinical Trial Sponsors:
Establishment and Operation of Clinical
Trial Data Monitoring Committees’’
dated March 2006. The guidance is
intended to assist sponsors of clinical
trials in determining when a data
monitoring committee (DMC) is needed
for study monitoring, and how such
committees should operate. The
guidance announced in this notice
finalizes the draft guidance entitled
‘‘Guidance for Clinical Trial Sponsors
on the Establishment and Operation of
Clinical Trial Data Monitoring
Committees’’ dated November 2001.
DATES: Submit written or electronic
comments on agency guidances at any
time.
Submit written requests for
single copies of the guidance to the
Office of Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448; the Drug
Information Branch (HFD–210), Center
for Drug Evaluation and Research
(CDER), Food and Drug Administration,
ADDRESSES:
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
5600 Fishers Lane, Rockville, MD
20857; or the Division of Small
Manufacturers, International, and
Consumer Assistance (HFZ–220), Center
for Devices and Radiological Health,
Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800; or the
CDRH Facts-On-Demand system at 1–
800–899–0381 or 301–827–0111. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Stephen M. Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852–
1448, 301–827–6210; Robert Temple,
E:\FR\FM\28MRN1.SGM
28MRN1
]]>Agencies
[Federal Register Volume 71, Number 59 (Tuesday, March 28, 2006)]
[Notices]
[Pages 15420-15421]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-4440]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0508]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Survey of Health Care
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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by April
27, 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 Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Survey of Health Care Practitioners Regarding Their Preferences for
Public Health Notifications (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 the use of medical devices. This
particular tool is meant to serve a specific purpose not served by the
other communication tools at our
[[Page 15421]]
disposal--to be a source of information for health care 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
health care 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 health care 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 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 health care
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.
In the Federal Register of January 9, 2006 (71 FR 1428), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Survey of health care providers in relevant specialty 300 1 300 .1666 50
--------------------------------------------------------------------------------------------------------------------------------------------------------
Survey of health care 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: March 22, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-4440 Filed 3-27-06; 8:45 am]
BILLING CODE 4160-01-S
