Agency Forms Undergoing Paperwork Reduction Act Review, 42076-42077 [E9-20000]
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42076
Federal Register / Vol. 74, No. 160 / Thursday, August 20, 2009 / Notices
6 MONTHS ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Type of respondent
Number of
responses/
respondent
Average burden hours per
response
Total burden
hours
Hospital staff (data collection) .........................................................................
State/Territory Preparedness staff (training) ...................................................
State/Territory Preparedness staff (data collection) ........................................
6000
62
62
96
1
288
1
1
3
576,000
62
53,568
Total ..........................................................................................................
........................
386
........................
635,630
The burden was determined by asking
the States that participated in a pilot
study to report who collected the data
and how long it took them to gather the
information.
Terry Nicolosi,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. E9–20073 Filed 8–19–09; 8:45 am]
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: August 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–19972 Filed 8–19–09; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Centers for Disease Control and
Prevention
[Docket No. FDA–2009–N–0030]
[30Day–09–09AA]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Investigational New Drug Regulations
Agency Forms Undergoing Paperwork
Reduction Act Review
AGENCY:
Food and Drug Administration,
HHS.
sroberts on DSKD5P82C1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Investigational New Drug Regulations’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
Elizabeth.Berbakos@fda.hhs.gov, 301–
796–3792.
SUPPLEMENTARY INFORMATION: In the
Federal Register of May 8, 2009 (74 FR
21690), the agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. 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 0910–0014. The
approval expires on August 31, 2011. A
copy of the supporting statement for this
VerDate Nov<24>2008
16:07 Aug 19, 2009
Jkt 217001
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an
e-mail to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
BioSense—Recruitment of Data
Sources—Existing Data Collection
Without an OMB Number—National
Center for Public Health Informatics
(NCPHI), Coordinating Center for Health
Information and Service (CCHIS),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Congress passed the Public Health
Security and Bioterrorism Preparedness
and Response Act of 2002, which
requires specific activities related to
bioterrorism preparedness and response.
This congressional mandate outlines the
need for improving the overall public’s
health through electronic surveillance.
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The Department of Health and Human
Services outlined strategies aimed at
achieving this goal via the Public Health
IT Initiative thereby creating the
BioSense program.
BioSense is a national, human health
surveillance system designed to
improve the nation’s capabilities for
disease detection, monitoring, and realtime health situational awareness. This
work is enhanced by providing public
health real-time access to existing data
from healthcare organizations, state
syndromic surveillance systems,
national laboratories, and others for just
in time public health decisionmaking;
this information is made available to
users in the BioSense Application. The
application provides data, charts,
graphs, and maps through a secure Webbased interface which can be accessed
by CDC and authorized users from state
and local public health departments and
healthcare organizations.
In order to meet the congressional
mandate, the BioSense program must
have access to electronic health data.
Recruitment of data sources includes
collecting information on the types of
data available, the types of computer
systems used, and the approximate
record volume. This information is used
by BioSense personnel and contractors
to determine technical requirements for
linking a data source into the BioSense
program. To collect this information, a
series of questionnaires in an Excel
spreadsheet have been designed.
Information collection will take place
during and after on-site visits by
BioSense personnel and contractors. We
estimate that such information will be
collected from 20 new entities (each
representing many facilities or clinics)
each year.
Since the publication of the 60-day
Federal Register Notice, the information
collection instrument for the provision
of access to the BioSense Application
has been included in this information
collection request. Access to the
BioSense Application is obtained using
an automated data collection form. This
form is completed on the Internet via
the CDC Secure Data Network (SDN) in
which a prospective user identifies what
E:\FR\FM\20AUN1.SGM
20AUN1
42077
Federal Register / Vol. 74, No. 160 / Thursday, August 20, 2009 / Notices
activities are requested. Potential users
must request and receive permission to
view the BioSense Application. Federal
rules mandate that this permission be
renewed each year. We estimate about
800 users per year will need to request
new or continued access to the BioSense
Application.
There is no cost to respondents other
than their time. The total estimated
annual burden hours are 147 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Type of respondents
Average burden
per response
(in hours)
Recruitment of Prospective Data Source Entities
Federal, State & Local Governments, Private Sector .....................................................
20
1
4
800
1
5/60
Access to BioSense Application
Federal, State & Local Governments, Private Sector .....................................................
Dated: August 14, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–20000 Filed 8–19–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0077]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
MedWatch: Food and Drug
Administration Medical Products
Reporting Program
AGENCY:
Food and Drug Administration,
HHS.
sroberts on DSKD5P82C1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘MedWatch: Food and Drug
Administration Medical Products
Reporting Program’’ has been approved
by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
Elizabeth.Berbakos@fda.hhs.gov, 301–
796–3792.
SUPPLEMENTARY INFORMATION: In the
Federal Register of September 24, 2008
(73 FR 55111), the agency announced
that the proposed information collection
had been submitted to OMB for review
and clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
VerDate Nov<24>2008
16:07 Aug 19, 2009
Jkt 217001
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0291. The
approval expires on December 31, 2011.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
Dated: August 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–19980 Filed 8–19–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DATES: Comments on this notice must be
received by September 21, 2009.
ADDRESSES: Written comments should
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by email at OIRA_submission@omb.eop.gov
(attention: AHRQ’s desk officer).
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at doris.lefkowitz@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
Agency for Healthcare Research and
Quality
2010–2011 Medical Expenditure Panel
Survey Insurance Component
Agency Information Collection
Activities: Proposed Collection;
Comment Request
AHRQ seeks to renew the Medical
Expenditure Panel Survey Insurance
Component (MEPS–IC) for calendar
years 2010 and 2011. The MEPS–IC, an
annual survey of the characteristics of
employer-sponsored health insurance,
was first conducted by AHRQ in 1997
for the calendar year 1996. The survey
has since been conducted annually for
calendar years 1996 through 2009,
except for 2007. A change from prior
year collection to calendar year
collection in 2008 meant that no data
were collected for the 2007 calendar
year, but the change has allowed for
much earlier release of the survey
results for the 2008 calendar year
forward. AHRQ is authorized to conduct
the MEPS–IC pursuant to 42 U.S.C.
299b–2.
Employment-based health insurance
is the source of coverage for over 90
million workers and their family
members, and is a cornerstone of the
current U.S. health care system. The
MEPS–IC measures the extent, cost, and
coverage of employment-based health
AGENCY: Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
SUMMARY: This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project: ‘‘2010–
2011 Medical Expenditure Panel Survey
Insurance Component.’’ In accordance
with the Paperwork Reduction Act of
1995, 44 U.S.C. 3506(c)(2)(A), AHRQ
invites the public to comment on this
proposed information collection.
This proposed information collection
was previously published in the Federal
Register on June 16th, 2009 and allowed
60 days for public comment. No
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment.
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20AUN1
Agencies
[Federal Register Volume 74, Number 160 (Thursday, August 20, 2009)]
[Notices]
[Pages 42076-42077]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20000]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-09-09AA]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC or by fax to (202) 395-5806.
Written comments should be received within 30 days of this notice.
Proposed Project
BioSense--Recruitment of Data Sources--Existing Data Collection
Without an OMB Number--National Center for Public Health Informatics
(NCPHI), Coordinating Center for Health Information and Service
(CCHIS), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Congress passed the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002, which requires specific
activities related to bioterrorism preparedness and response. This
congressional mandate outlines the need for improving the overall
public's health through electronic surveillance. The Department of
Health and Human Services outlined strategies aimed at achieving this
goal via the Public Health IT Initiative thereby creating the BioSense
program.
BioSense is a national, human health surveillance system designed
to improve the nation's capabilities for disease detection, monitoring,
and real-time health situational awareness. This work is enhanced by
providing public health real-time access to existing data from
healthcare organizations, state syndromic surveillance systems,
national laboratories, and others for just in time public health
decisionmaking; this information is made available to users in the
BioSense Application. The application provides data, charts, graphs,
and maps through a secure Web-based interface which can be accessed by
CDC and authorized users from state and local public health departments
and healthcare organizations.
In order to meet the congressional mandate, the BioSense program
must have access to electronic health data. Recruitment of data sources
includes collecting information on the types of data available, the
types of computer systems used, and the approximate record volume. This
information is used by BioSense personnel and contractors to determine
technical requirements for linking a data source into the BioSense
program. To collect this information, a series of questionnaires in an
Excel spreadsheet have been designed. Information collection will take
place during and after on-site visits by BioSense personnel and
contractors. We estimate that such information will be collected from
20 new entities (each representing many facilities or clinics) each
year.
Since the publication of the 60-day Federal Register Notice, the
information collection instrument for the provision of access to the
BioSense Application has been included in this information collection
request. Access to the BioSense Application is obtained using an
automated data collection form. This form is completed on the Internet
via the CDC Secure Data Network (SDN) in which a prospective user
identifies what
[[Page 42077]]
activities are requested. Potential users must request and receive
permission to view the BioSense Application. Federal rules mandate that
this permission be renewed each year. We estimate about 800 users per
year will need to request new or continued access to the BioSense
Application.
There is no cost to respondents other than their time. The total
estimated annual burden hours are 147 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Recruitment of Prospective Data Source Entities
----------------------------------------------------------------------------------------------------------------
Federal, State & Local Governments, Private Sector........ 20 1 4
----------------------------------------------------------------------------------------------------------------
Access to BioSense Application
----------------------------------------------------------------------------------------------------------------
Federal, State & Local Governments, Private Sector........ 800 1 5/60
----------------------------------------------------------------------------------------------------------------
Dated: August 14, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E9-20000 Filed 8-19-09; 8:45 am]
BILLING CODE 4163-18-P