Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Shortages Data Collection System (formerly “Emergency Medical Device Shortages Program Survey”), 21688-21689 [E9-10816]
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21688
Federal Register / Vol. 74, No. 88 / Friday, May 8, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute for Occupational
Safety and Health
National Institute for Occupational
Safety and Health
Food and Drug Administration
Final Effect of Designation of a Class
of Employees for Addition to the
Special Exposure Cohort
Final Effect of Designation of a Class
of Employees for Addition to the
Special Exposure Cohort
AGENCY: National Institute for
Occupational Safety and Health
(NIOSH), Department of Health and
Human Services (HHS).
AGENCY: National Institute for
Occupational Safety and Health
(NIOSH), Department of Health and
Human Services (HHS).
ACTION:
Notice.
ACTION:
SUMMARY: HHS gives notice concerning
the final effect of the HHS decision to
designate a class of employees at
Westinghouse Atomic Power
Development Plant in East Pittsburgh,
Pennsylvania, as an addition to the
Special Exposure Cohort (SEC) under
the Energy Employees Occupational
Illness Compensation Program Act of
2000. On March 31, 2009, as provided
for under 42 U.S.C. 7384q(b), the
Secretary of HHS designated the
following class of employees as an
addition to the SEC:
All Atomic Weapons Employer employees
who worked at Westinghouse Atomic Power
Development Plant in East Pittsburgh,
Pennsylvania, from August 13, 1942 through
December 31, 1944, for a number of work
days aggregating at least 250 work days,
occurring either solely under this
employment or in combination with work
days within the parameters established for
one or more other classes of employees in the
SEC.
hsrobinson on PROD1PC76 with NOTICES
This designation became effective on
April 30, 2009, as provided for under 42
U.S.C. 7384l(14)(C). Hence, beginning
on April 30, 2009, members of this class
of employees, defined as reported in
this notice, became members of the
Special Exposure Cohort.
FOR FURTHER INFORMATION CONTACT:
Larry Elliott, Director, Office of
Compensation Analysis and Support,
National Institute for Occupational
Safety and Health (NIOSH), 4676
Columbia Parkway, MS C–46,
Cincinnati, OH 45226, Telephone 513–
533–6800 (this is not a toll-free
number). Information requests can also
be submitted by e-mail to
OCAS@CDC.GOV.
Christine M. Branche,
Acting Director, National Institute for
Occupational Safety and Health.
[FR Doc. E9–10829 Filed 5–7–09; 8:45 am]
Notice.
17:51 May 07, 2009
Jkt 217001
SUMMARY: HHS gives notice concerning
the final effect of the HHS decision to
designate a class of employees at Tyson
Valley Powder Farm near Eureka,
Missouri, as an addition to the Special
Exposure Cohort (SEC) under the Energy
Employees Occupational Illness
Compensation Program Act of 2000. On
March 31, 2009, as provided for under
42 U.S.C. 7384q(b), the Secretary of
HHS designated the following class of
employees as an addition to the SEC:
All Atomic Weapons Employer (AWE)
employees who worked at Tyson Valley
Powder Farm near Eureka, Missouri, from
February 13, 1946 through June 30, 1948, for
a number of work days aggregating at least
250 work days, occurring either solely under
this employment or in combination with
work days within the parameters established
for one or more other classes of employees
in the SEC.
This designation became effective on
April 30, 2009, as provided for under 42
U.S.C. 7384l(14)(C). Hence, beginning
on April 30, 2009, members of this class
of employees, defined as reported in
this notice, became members of the
Special Exposure Cohort.
FOR FURTHER INFORMATION CONTACT:
Larry Elliott, Director, Office of
Compensation Analysis and Support,
National Institute for Occupational
Safety and Health (NIOSH), 4676
Columbia Parkway, MS C–46,
Cincinnati, OH 45226, Telephone 513–
533–6800 (this is not a toll-free
number). Information requests can also
be submitted by e-mail to
OCAS@CDC.GOV.
Christine M. Branche,
Acting Director, National Institute for
Occupational Safety and Health.
[FR Doc. E9–10830 Filed 5–7–09; 8:45 am]
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Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Emergency
Shortages Data Collection System
(formerly ‘‘Emergency Medical Device
Shortages Program Survey’’)
AGENCY:
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VerDate Nov<24>2008
[Docket No. FDA–2008–N–0635]
Sfmt 4703
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 June 8,
2009.
ADDRESSES: 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: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0491. Also
include the FDA 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.
In
compliance with 44 U.S.C. 3507, FDA
published a 30-day notice in the Federal
Register of March 16, 2009 (74 FR
11116), that: (1) Responded to
comments on the information collection
provisions received in response to a 60day notice that published in the Federal
Register of December 19, 2008 (73 FR
77718), and (2) announced submission
of the proposed collection of
information to OMB for review and
clearance. In response to a request by
OMB, FDA is republishing the 30-day
notice of the proposed collection of
information set forth in this document.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\08MYN1.SGM
08MYN1
21689
Federal Register / Vol. 74, No. 88 / Friday, May 8, 2009 / Notices
Emergency Shortages Data Collection
System (formerly ‘‘Emergency Medical
Device Shortages Program Survey’’)—
Section 903(d)(2) of the Federal Food,
Drug, and Cosmetic Act (OMB Control
Number 0910–0491)—Extension
Under section 903(d)(2) of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 393(d)(2)), the FDA
Commissioner is authorized to
implement general powers (including
conducting research) to carry out
effectively the mission of FDA.
Subsequent to the events of September
11, 2001, and as part of broader counterterrorism and emergency preparedness
activities, FDA’s Center for Devices and
Radiological Health (CDRH) began
developing operational plans and
interventions that would enable CDRH
to anticipate and respond to medical
device shortages that might arise in the
context of federally-declared disasters/
emergencies or regulatory actions. In
particular, CDRH identified the need to
acquire and maintain detailed data on
domestic inventory, manufacturing
capabilities, distribution plans and raw
material constraints for medical devices
that would be in high demand, and/or
would be vulnerable to shortages in
specific disaster/emergency situations,
or following specific regulatory actions.
Such data could support prospective
risk assessment, help inform risk
mitigation strategies, and support realtime decisionmaking by the Department
of Health and Human Services during
actual emergencies or emergency
preparedness exercises.
‘‘The Emergency Medical Device
Shortages Program Survey’’ was
developed in 2002 to support the
acquisition of such data from medical
device manufacturers. In 2004, CDRH
changed the process for the data
collection, and the electronic database
in which the data were stored and was
formally renamed the ‘‘Emergency
Shortages Data Collection System’’
(ESDCS). Recognizing that some of the
data collected may be commercially
confidential, access to ESDCS is
restricted to members of the FDA
Emergency Shortage Team (EST) and
senior management with a need-toknow. At this time, the need-to-know
senior management personnel are
limited to 5 senior managers. Further,
the data are used by this defined group
only for decisionmaking and planning
in the context of a federally-declared
disaster/emergency, an official
emergency preparedness exercise, or a
potential public health risk posed by
non-disaster-related device shortage.
The data procurement process
consists of an initial scripted telephone
call to a regulatory officer at a registered
manufacturer of one or more key
medical devices being tracked in the
emergency shortages data collection
system. In this initial call, the intent and
goals of the data collection effort are
described, and the specific data request
is made. After the initial call, one or
more additional followup calls and/or
electronic mail correspondence may be
required to verify/validate data sent
from the manufacturer, confirm receipt
and/or request additional detail.
Although the regulatory officer is the
agent who is initially contacted, they
may designate an alternate
representative within their organization
to correspond subsequently with the
CDRH EST member who is collecting or
verifying/validating the data.
Because of the dynamic nature of the
medical device industry, particularly
with respect to specific product lines,
manufacturing capabilities and raw
material/subcomponent sourcing, it is
necessary to update the data in the
ESDCS at regular intervals. This is done
on a weekly basis, but efforts are made
to limit the frequency of outreach to a
specific manufacturer to no more than
every 4 months.
The ESDCS will only include those
medical devices for which there will
likely be high demand during a specific
emergency/disaster, or for which there
are sufficiently small numbers of
manufacturers such that disruption of
manufacture or loss of one or more of
these manufacturers would create a
shortage.
In the Federal Register of December
19, 2008 (73 FR 77718), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Section of the Act
903(d)(2)
hsrobinson on PROD1PC76 with NOTICES
1There
Annual Frequency
per
Response
125
Total Annual
Responses
3
Hours per
Response
375
Total Hours
0.5
188
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based the burden estimates in
Table 1 of this document on past
experience with direct contact with the
medical device manufacturers, and
anticipated changes in the medical
device manufacturing patterns for the
specific devices being monitored. FDA
estimates that approximately 125
manufacturers would be contacted by
telephone and/or electronic mail 3 times
per year to either obtain primary data or
to verify/validate data. Because the data
being requested represent data elements
that are monitored or tracked by
manufacturers as part of routine
inventory management activities, it is
anticipated that for most manufacturers,
the estimated time required of
manufacturers to complete the data
VerDate Nov<24>2008
17:51 May 07, 2009
Jkt 217001
request will not exceed 30 minutes per
request cycle.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: May 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–10816 Filed 5–7–09; 8:45 am]
Administration for Children and
Families
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Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Title IV–E Foster Care Eligibility
Review and Child and Family Service
Reviews; Final Rule.
OMB No.: 0970–0214.
Description: The following five
separate activities are associated with
this information collection: Foster Care
Eligibility Review (FCER) Program
Improvement Plan; Child and Family
Services Reviews (CFSR) State agency
Sfmt 4703
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]]>Agencies
[Federal Register Volume 74, Number 88 (Friday, May 8, 2009)]
[Notices]
[Pages 21688-21689]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10816]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0635]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Emergency Shortages
Data Collection System (formerly ``Emergency Medical Device Shortages
Program Survey'')
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 June 8,
2009.
ADDRESSES: 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: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0491.
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA
published a 30-day notice in the Federal Register of March 16, 2009 (74
FR 11116), that: (1) Responded to comments on the information
collection provisions received in response to a 60-day notice that
published in the Federal Register of December 19, 2008 (73 FR 77718),
and (2) announced submission of the proposed collection of information
to OMB for review and clearance. In response to a request by OMB, FDA
is republishing the 30-day notice of the proposed collection of
information set forth in this document.
[[Page 21689]]
Emergency Shortages Data Collection System (formerly ``Emergency
Medical Device Shortages Program Survey'')--Section 903(d)(2) of the
Federal Food, Drug, and Cosmetic Act (OMB Control Number 0910-0491)--
Extension
Under section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 393(d)(2)), the FDA Commissioner is authorized to
implement general powers (including conducting research) to carry out
effectively the mission of FDA. Subsequent to the events of September
11, 2001, and as part of broader counter-terrorism and emergency
preparedness activities, FDA's Center for Devices and Radiological
Health (CDRH) began developing operational plans and interventions that
would enable CDRH to anticipate and respond to medical device shortages
that might arise in the context of federally-declared disasters/
emergencies or regulatory actions. In particular, CDRH identified the
need to acquire and maintain detailed data on domestic inventory,
manufacturing capabilities, distribution plans and raw material
constraints for medical devices that would be in high demand, and/or
would be vulnerable to shortages in specific disaster/emergency
situations, or following specific regulatory actions. Such data could
support prospective risk assessment, help inform risk mitigation
strategies, and support real-time decisionmaking by the Department of
Health and Human Services during actual emergencies or emergency
preparedness exercises.
``The Emergency Medical Device Shortages Program Survey'' was
developed in 2002 to support the acquisition of such data from medical
device manufacturers. In 2004, CDRH changed the process for the data
collection, and the electronic database in which the data were stored
and was formally renamed the ``Emergency Shortages Data Collection
System'' (ESDCS). Recognizing that some of the data collected may be
commercially confidential, access to ESDCS is restricted to members of
the FDA Emergency Shortage Team (EST) and senior management with a
need-to-know. At this time, the need-to-know senior management
personnel are limited to 5 senior managers. Further, the data are used
by this defined group only for decisionmaking and planning in the
context of a federally-declared disaster/emergency, an official
emergency preparedness exercise, or a potential public health risk
posed by non-disaster-related device shortage.
The data procurement process consists of an initial scripted
telephone call to a regulatory officer at a registered manufacturer of
one or more key medical devices being tracked in the emergency
shortages data collection system. In this initial call, the intent and
goals of the data collection effort are described, and the specific
data request is made. After the initial call, one or more additional
followup calls and/or electronic mail correspondence may be required to
verify/validate data sent from the manufacturer, confirm receipt and/or
request additional detail. Although the regulatory officer is the agent
who is initially contacted, they may designate an alternate
representative within their organization to correspond subsequently
with the CDRH EST member who is collecting or verifying/validating the
data.
Because of the dynamic nature of the medical device industry,
particularly with respect to specific product lines, manufacturing
capabilities and raw material/subcomponent sourcing, it is necessary to
update the data in the ESDCS at regular intervals. This is done on a
weekly basis, but efforts are made to limit the frequency of outreach
to a specific manufacturer to no more than every 4 months.
The ESDCS will only include those medical devices for which there
will likely be high demand during a specific emergency/disaster, or for
which there are sufficiently small numbers of manufacturers such that
disruption of manufacture or loss of one or more of these manufacturers
would create a shortage.
In the Federal Register of December 19, 2008 (73 FR 77718), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Section of the No. of Annual Frequency Total Annual Hours per
Act Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
903(d)(2) 125 3 375 0.5 188
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based the burden estimates in Table 1 of this document on past
experience with direct contact with the medical device manufacturers,
and anticipated changes in the medical device manufacturing patterns
for the specific devices being monitored. FDA estimates that
approximately 125 manufacturers would be contacted by telephone and/or
electronic mail 3 times per year to either obtain primary data or to
verify/validate data. Because the data being requested represent data
elements that are monitored or tracked by manufacturers as part of
routine inventory management activities, it is anticipated that for
most manufacturers, the estimated time required of manufacturers to
complete the data request will not exceed 30 minutes per request cycle.
Dated: May 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-10816 Filed 5-7-09; 8:45 am]
BILLING CODE 4160-01-S
