Submission for OMB Review; Comment Request, 45857-45858 [E9-21410]
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Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices
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Transaction Publishers, Inc., 35
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Dated: August 31, 2009.
Karen V. Gregory,
Secretary.
[FR Doc. E9–21331 Filed 9–3–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Chronic Fatigue
Syndrome Advisory Committee
AGENCY: Department of Health and
Human Services, Office of the Secretary,
Office of Public Health and Science.
ACTION: Notice.
SUMMARY: As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Services is hereby giving notice that the
Chronic Fatigue Syndrome Advisory
Committee (CFSAC) will hold a
meeting. The meeting will be open to
the public.
DATES: The meeting will be held on
Thursday, October 29, 2009, and Friday,
October 30, 2009. The meeting will be
held from 9 a.m. until 5 p.m. on both
days.
ADDRESSES: Department of Health and
Human Services; Room 800, Hubert H.
Humphrey Building; 200 Independence
Avenue, SW., Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT:
Wanda K. Jones, Dr.P.H.; Executive
Secretary, Chronic Fatigue Syndrome
Advisory Committee, Department of
Health and Human Services; 200
Independence Avenue, SW., Hubert
Humphrey Building, Room 712E;
Washington, DC 20201; (202) 690–7650.
SUPPLEMENTARY INFORMATION:
CFSAC was established on September
5, 2002. The Committee was established
to advise, consult with, and make
recommendations to the Secretary,
through the Assistant Secretary for
Health, on a broad range of topics
including (1) The current state of the
knowledge and research about the
epidemiology and risk factors relating to
chronic fatigue syndrome, and
identifying potential opportunities in
these areas; (2) current and proposed
diagnosis and treatment methods for
chronic fatigue syndrome; and (3)
development and implementation of
programs to inform the public, health
care professionals, and the biomedical,
academic, and research communities
about advances in chronic fatigue
syndrome.
The agenda for this meeting is being
developed. The agenda will be posted
on the CFSAC Web site, https://
www.hhs.gov/advcomcfs, when it is
finalized. In addition, the meeting will
be WebCast. Details will be posted to
the CFSAC Web site as they become
available.
Public attendance at the meeting is
limited to space available. Individuals
must provide a photo ID for entry into
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45857
the building where the meeting is
scheduled to be held. Individuals who
plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify the
designated contact person. Members of
the public will have the opportunity to
provide comments at the meeting.
Individuals who wish to address the
Committee during the public comment
session must pre-register by October 14,
2009. Any individual who wishes to
participate in the public comment
session should call the telephone
number listed in the contact information
or send an e-mail to cfsac@hhs.gov to
register. Public comments will be
limited to five minutes per speaker.
Members of the public who wish to
have printed material distributed to
CFSAC members for discussion should
submit, at a minimum, one copy of the
material to the Executive Secretary,
CFSAC, prior to close of business on
October 15, 2009. Submissions are
limited to five typewritten pages.
Contact information for the Executive
Secretary is listed above.
Dated: August 20, 2009.
Wanda K. Jones,
Executive Secretary, CFSAC.
[FR Doc. E9–21334 Filed 9–3–09; 8:45 am]
BILLING CODE 4150–42–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Child Care and Development
Fund Annual Aggregate Report—ACF–
800.
OMB No.: 0970–0150.
Description: Section 658K of the Child
Care and Development Block Grant Act
of 1990 (Pub. L. 101–508, 42 U.S.C.
9858) requires that States and
Territories submit annual aggregate data
on the children and families receiving
direct services under the Child Care and
Development Fund. The implementing
regulations for the statutorily required
reporting are at 45 CFR 98.70. Annual
aggregate reports include data elements
represented in the ACF–800 reflecting
the scope, type, and methods of child
care delivery. This provides ACF with
the information necessary to make
reports to Congress, address national
child care needs, offer technical
assistance to grantees, meet performance
measures, and conduct research.
Consistent with the statute and
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Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices
regulations, ACF requests extension of
the ACF–800. With this extension, ACF
is proposing several changes and
clarifications to the reporting
requirements and instructions.
Respondents: States, the District of
Columbia, and Territories including
Puerto Rico, Guam, the Virgin Islands,
American Samoa, and the Northern
Marianna Islands.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ACF–800 ..........................................................................................................
56
1
40
2,240
Estimated Total Annual Burden Hours: 2,240
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: September 1, 2009.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. E9–21410 Filed 9–3–09; 8:45 am]
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 October 5,
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–NEW and
title, ‘‘Evaluation of Potential Data
Sources for the Sentinel Initiative.’’ Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794,
JonnaLynn.Capezzuto@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Evaluation of Potential Data Sources for
the Sentinel Initiative
Food and Drug Administration
In September 2005, the Secretary of
Health and Human Services (the
Secretary) asked FDA to expand its
current system for monitoring medical
product performance. The Secretary
asked FDA to explore the possibility of
working in collaboration with multiple
healthcare data systems to augment
FDA’s capability of identifying and
evaluating product safety information
beyond its existing voluntary reporting
systems. Such a step would strengthen
FDA’s ability, ultimately, to monitor the
performance of a product after
marketing approval. The Secretary
recommended that FDA explore creating
a public-private collaboration as a
srobinson on DSKHWCL6B1PROD with NOTICES
[Docket No. FDA–2009–N–0098]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Evaluation of
Potential Data Sources for the Sentinel
Initiative
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
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framework for such an effort leveraging
increasingly available large, electronic
healthcare databases and taking
advantage of emerging technologies and
building on existing systems and efforts,
rather than creating new systems.
In 2006, the Institute of Medicine
(IOM) issued a report entitled ‘‘The
Future of Drug Safety—Promoting and
Protecting the Health of the Public.’’1
Among other suggestions, this IOM
report recommended FDA identify ways
to access other health-related databases
and create a public-private partnership
to support safety and efficacy studies.
In 2007, Congress enacted the Food
and Drug Administration Amendments
Act of 20072 (FDAAA). Section 905 of
FDAAA calls for the Secretary to
develop methods to obtain access to
disparate data sources and to establish
an active postmarket risk identification
and analysis system that links and
analyzes healthcare data from multiple
sources. The law sets a goal of access to
data from 25 million patients by July 1,
2010, and 100 million patients by July
1, 2012. The law also requires FDA to
work closely with partners from public,
academic, and private entities. FDA
views the Sentinel Initiative as a
mechanism through which this mandate
can be carried out.
Consistent with FDA’s mission to
protect and promote the public health,
FDA is embarking on the Sentinel
Initiative to create a national, electronic
distributed system, strengthening FDA’s
ability to monitor the post-market
performance of a product. As currently
envisioned, the Sentinel Initiative will
enable FDA to capitalize on the
capabilities of multiple, existing data
systems (e.g. electronic health record
systems and medical claims databases)
1 Institute of Medicine, ‘‘The Future of Drug
Safety—Promoting and Protecting the Health of the
Public,’’ September 22, 2006, https://www.iom.edu/
. (FDA has verified the Web site address, but FDA
is not responsible for any subsequent changes to the
Web site after this document publishes in the
Federal Register.)
2 Food and Drug Administration Amendments
Act of 2007, Public Law 110–85, was signed into
law in September 2007. See Title IX, Section 905.
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[Federal Register Volume 74, Number 171 (Friday, September 4, 2009)]
[Notices]
[Pages 45857-45858]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-21410]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Child Care and Development Fund Annual Aggregate Report--
ACF-800.
OMB No.: 0970-0150.
Description: Section 658K of the Child Care and Development Block
Grant Act of 1990 (Pub. L. 101-508, 42 U.S.C. 9858) requires that
States and Territories submit annual aggregate data on the children and
families receiving direct services under the Child Care and Development
Fund. The implementing regulations for the statutorily required
reporting are at 45 CFR 98.70. Annual aggregate reports include data
elements represented in the ACF-800 reflecting the scope, type, and
methods of child care delivery. This provides ACF with the information
necessary to make reports to Congress, address national child care
needs, offer technical assistance to grantees, meet performance
measures, and conduct research. Consistent with the statute and
[[Page 45858]]
regulations, ACF requests extension of the ACF-800. With this
extension, ACF is proposing several changes and clarifications to the
reporting requirements and instructions.
Respondents: States, the District of Columbia, and Territories
including Puerto Rico, Guam, the Virgin Islands, American Samoa, and
the Northern Marianna Islands.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
ACF-800..................................... 56 1 40 2,240
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 2,240
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: September 1, 2009.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. E9-21410 Filed 9-3-09; 8:45 am]
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