Proposed Information Collection Activity; Comment Request, 21370-21371 [E9-10622]
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21370
Federal Register / Vol. 74, No. 87 / Thursday, May 7, 2009 / Notices
Dated: May 1, 2009.
Marilyn S. Radke,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. E9–10617 Filed 5–6–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
Submission for OMB Review;
Comment Request
Administration for Children and
Families
Title: Head Start Facilities
Construction, Purchase and Major
Renovation—45 CFR 1309.
OMB No.: 0970–0193.
Description: The Office of Head Start
is proposing to renew, without changes,
45 CFR part 1309. This rule contains the
administrative requirements for Head
Start and Early Head Start grantees who
apply for funding to purchase, renovate,
or construct Head Start program
facilities. The rule ensures that grantees
use standard business practices when
acquiring real property and that Federal
interest is preserved in properties
acquired with public funds. The rule
further ensures compliance with all
other Federal statutes applicable to the
expenditure of Federal funds when
acquiring real property.
Respondents: Head Start and Early
Head Start grantees and delegate
agencies.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses
per
respondent
Average
burden
hours per
response
Total burden
hours
Regulation ........................................................................................................
200
1
41
8,200
Estimated Total Annual Burden
Hours: 8,200.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7245,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: May 4, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9–10621 Filed 5–6–09; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
OMB No.: 0980–0242.
Description: Section 646 of the Head
Start Act requires the Secretary of
Health and Human Services to prescribe
a timeline for conducting administrative
hearings when adverse actions are taken
or proposed against Head Start and
Early Head Start grantees and delegate
agencies. The Office of Head Start is
proposing to renew, without changes,
this rule, which implements these
requirements and which prescribes
when a grantee must submit certain
information and what that information
shall include.
Respondents: Head Start and Early
Head Start grantees and Delegate
Agencies.
Proposed Projects
Title: Head Start Program
Administrative Practice and Procedure;
Appeal Procedures, 45 CFR 1303.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses
per
respondent
Average
burden
hours per
response
Total burden
hours
Rule ..................................................................................................................
20
1
26
520
Estimated Total Annual Burden
Hours: 520.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
VerDate Nov<24>2008
17:03 May 06, 2009
Jkt 217001
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
PO 00000
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Fmt 4703
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Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
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Federal Register / Vol. 74, No. 87 / Thursday, May 7, 2009 / Notices
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: May 4, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9–10622 Filed 5–6–09; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0192]
Availability of Information Related to
the Sentinel Initiative
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
opening of a docket to receive and to
make available to the public reports and
other relevant information received by
FDA related to the Sentinel Initiative.
The goal of the Sentinel Initiative is to
develop a system that will ultimately
enable FDA to actively monitor the
safety of marketed regulated products.
The information that will be made
available is being developed primarily,
but not exclusively, as a result of a
series of contracts awarded by FDA to
inform the development of the system.
The information will be made available
in the docket under the docket number
at the top of this notice, as well as on
FDA’s Sentinel Initiative Web page
(Sentinel Web page) at https://
www.fda.gov/oc/initiatives/advance/
sentinel/. FDA welcomes interested
parties, including individuals, to submit
to this docket their views and
perspectives on the information
included in the docket or on any other
aspect of the Sentinel Initiative.
DATES: Submit written or electronic
comments at any time.
VerDate Nov<24>2008
17:03 May 06, 2009
Jkt 217001
Submit written comments
on the information in this docket 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.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the information.
FOR FURTHER INFORMATION CONTACT:
Melissa Robb, Office of Critical Path
Programs, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1512.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
An important part of FDA’s mission is
to protect public health by monitoring
the safety of marketed regulated
products. FDA currently has a number
of reporting systems in place for
learning about and tracking reports of
adverse events and product problems
associated with the use of FDAregulated products. However, most of
these systems are passive; someone (e.g.,
a healthcare professional, consumer,
pharmaceutical company) must first
report such an event or problem to FDA.
To augment this mostly passive
approach to monitoring postmarket
safety, FDA announced in May 2008 the
development of a system that would
enable FDA to capitalize on the
capabilities of multiple existing
electronic health care data systems (e.g.
electronic health record systems,
administrative claims databases,
registries) to actively monitor regulated
product safety.
As currently envisioned, the system
would enable FDA to query large
participating data sources quickly and
securely for relevant product safety
information. FDA would send questions
to participating data holders, who in
turn would, in accordance with existing
privacy and security safeguards,
evaluate their data and send summary
results to FDA for agency review. This
system, which will be developed and
implemented in stages, is expected to
facilitate the development of active
surveillance methodologies related to
signal detection, signal strengthening,
and signal validation.
To be successful, the system will
require the participation of many
stakeholders. Since announcing the
Sentinel Initiative, FDA has fostered a
broad public forum to explore the
complexities of creating such a system.
Numerous meetings have been held
with a variety of stakeholders. Eight
contracts have been awarded to explore
a variety of topics that will inform the
development of the system, and a
PO 00000
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21371
number of pilot projects are under way
that will contribute to answering some
of the many technical and policy
challenges that need to be addressed. To
ensure the broadest possible availability
of information related to FDA’s Sentinel
Initiative and to encourage public
participation in the initiative, FDA is
announcing the opening of a docket to
receive and make available to the public
reports and other information received
by FDA related to the Sentinel Initiative.
FDA is making this information
available in the docket listed at the top
of this notice, as well as on FDA’s
Sentinel Web page at https://
www.fda.gov/oc/initiatives/advance/
sentinel/.
FDA is interested in receiving input
from interested parties, including
individuals, and encourages those
parties to submit to this docket relevant
views and perspectives on the
information included in the docket or
on any other aspect of the Sentinel
Initiative.
As reports and other relevant
information are submitted to the agency,
FDA will make them available to the
public by placing them in the docket
and posting them on the Sentinel Web
page. Those persons wishing to provide
their views and perspectives are
encouraged to send their input to the
docket for broad public consideration.
II. Documents Being Submitted With
This Notice
FDA is making available with this
notice the first of a series of documents
containing reports and other
information related to the Sentinel
Initiative. This document contains a
report from the Group Health
Cooperative Center for Health Studies as
a result of the contract awarded on
Evaluation of Existing Methods for
Safety Signal Identification for the
Sentinel Initiative.
III. Submission of Input on the Contents
of This Docket
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic views
and perspectives regarding this
information. Submit a single copy of
electronic submissions or two paper
copies of any mailed submissions,
except that individuals may submit one
paper copy. Submissions are to be
identified with the docket number
found in brackets in the heading of this
document. Received submissions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
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]]>Agencies
[Federal Register Volume 74, Number 87 (Thursday, May 7, 2009)]
[Notices]
[Pages 21370-21371]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10622]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Head Start Program Administrative Practice and Procedure;
Appeal Procedures, 45 CFR 1303.
OMB No.: 0980-0242.
Description: Section 646 of the Head Start Act requires the
Secretary of Health and Human Services to prescribe a timeline for
conducting administrative hearings when adverse actions are taken or
proposed against Head Start and Early Head Start grantees and delegate
agencies. The Office of Head Start is proposing to renew, without
changes, this rule, which implements these requirements and which
prescribes when a grantee must submit certain information and what that
information shall include.
Respondents: Head Start and Early Head Start grantees and Delegate
Agencies.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Rule........................................ 20 1 26 520
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 520.
In compliance with the requirements of Section 506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Administration, Office of Information Services, 370 L'Enfant Promenade,
SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
[[Page 21371]]
The Department specifically requests comments on: (a) Whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Dated: May 4, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9-10622 Filed 5-6-09; 8:45 am]
BILLING CODE 4184-01-P
