Oklahoma; Emergency and Related Determinations, 6404-6405 [2010-2798]
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6404
Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Notices
Dated: February 1, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–2769 Filed 2–8–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0045] (formerly
Docket No. 2004N–0408)
Regulatory Site Visit Training Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA’s) Center for
Biologics Evaluation and Research
(CBER) is announcing an invitation for
participation in its Regulatory Site Visit
Training Program (RSVP). This training
program is intended to give CBER
regulatory review, compliance, and
other relevant staff an opportunity to
visit biologics facilities. These visits are
intended to allow CBER staff to directly
observe routine manufacturing practices
and to give CBER staff a better
understanding of the biologics industry,
including its challenges and operations.
The purpose of this notice is to invite
biologics facilities to contact CBER for
more information if they are interested
in participating in this program.
DATES: Submit a written or electronic
request for participation in this program
by March 11, 2010. The request should
include a description of your facility
relative to products regulated by CBER.
Please specify the physical address(es)
of the site(s) you are offering.
ADDRESSES: If your biologics facility is
interested in offering a site visit, you
should submit a request to participate in
the program to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic requests to https://
www.regulations.gov. If you previously
responded to earlier requests to
participate in this program and you
continue to be interested in
participating, please renew your request
through a submission to the Division of
Dockets Management.
FOR FURTHER INFORMATION CONTACT:
Lonnie W. Henderson, Division of
Manufacturers Assistance and Training,
Center for Biologics Evaluation and
Research (HFM–49), Food and Drug
Administration, 1401 Rockville Pike,
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SUMMARY:
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suite 200N, Rockville, MD 20852–1448,
301–827–2000, FAX: 301–827–3079, email: matt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
CBER regulates certain biological
products including blood and blood
products, vaccines, and cellular, tissue,
and gene therapies. CBER is committed
to advancing the public health through
innovative activities that help ensure
the safety, effectiveness and availability
of biological products to patients. To
support this primary goal, CBER has
initiated various training and
development programs, including
programs to further enhance
performance of its compliance staff,
regulatory review staff, and other
relevant staff. CBER seeks to
continuously enhance and update
review efficiency and quality, and the
quality of its regulatory efforts and
interactions, by providing CBER staff
with a better understanding of the
biologics industry and its operations.
Further, CBER seeks to enhance: (1) Its
understanding of current industry
practices, and regulatory impacts and
needs; and (2) communication between
CBER staff and industry. CBER initiated
its RSVP in 2005, and through these
annual notices, is requesting those firms
that have previously applied and are
still interested in participating, to
reaffirm their interest, as well as
requesting new interested parties to
apply.
II. RSVP
A. Regulatory Site Visits
In this program, over a period of time
to be agreed upon with the facility,
small groups of CBER staff may observe
operations of biologics establishments,
including for example, blood and tissue
establishments. The visits may include
packaging facilities, quality control and
pathology/toxicology laboratories, and
regulatory affairs operations. These
visits, or any part of the program, are
not intended as a mechanism to inspect,
assess, judge, or perform a regulatory
function, but are meant to improve
mutual understanding and to provide an
avenue for open dialogue between the
biologics industry and CBER.
B. Site Selection
All travel expenses associated with
the site visits will be the responsibility
of CBER. Therefore, selection of
potential facilities will be based on the
coordination of CBER’s priorities for
staff training as well as the limited
available resources for this program. In
addition to logistical and other resource
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factors to consider, a key element of site
selection is a successful compliance
record with FDA or another agency with
which we have a memorandum of
understanding. If a site visit also
involves a visit to a separate physical
location of another firm under contract
to the applicant, the other firm also
needs to agree to participate in the
program, as well as have a satisfactory
compliance history.
III. Requests for Participation
Requests are to be identified with the
docket number found in the brackets in
the heading of this document. Received
requests are available for public
examination in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–2758 Filed 2–8–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Internal Agency Docket No. FEMA–3308–
EM; Docket ID FEMA–2010–0002]
Oklahoma; Emergency and Related
Determinations
AGENCY: Federal Emergency
Management Agency, DHS.
ACTION: Notice.
SUMMARY: This is a notice of the
Presidential declaration of an
emergency for the State of Oklahoma
(FEMA–3308–EM), dated January 30,
2010, and related determinations.
DATES: Effective Date: January 30, 2010.
FOR FURTHER INFORMATION CONTACT:
Peggy Miller, Disaster Assistance
Directorate, Federal Emergency
Management Agency, 500 C Street, SW.,
Washington, DC 20472, (202) 646–3886.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that, in a letter dated
January 30, 2010, the President issued
an emergency declaration under the
authority of the Robert T. Stafford
Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121–5207
(the Stafford Act), as follows:
I have determined that the emergency
conditions in certain areas of the State of
Oklahoma resulting from a severe winter
storm beginning on January 28, 2010, and
continuing, are of sufficient severity and
magnitude to warrant an emergency
declaration under the Robert T. Stafford
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Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Notices
Disaster Relief and Emergency Assistance
Act, 42 U.S.C. 5121 et seq. (‘‘the Stafford
Act’’). Therefore, I declare that such an
emergency exists in the State of Oklahoma.
You are authorized to provide appropriate
assistance for required emergency measures,
authorized under Title V of the Stafford Act,
to save lives and to protect property and
public health and safety, and to lessen or
avert the threat of a catastrophe in the
designated areas. Specifically, you are
authorized to provide assistance for
emergency protective measures (Category B),
limited to direct Federal assistance, under
the Public Assistance program. This
assistance excludes regular time costs for
subgrantees’ regular employees.
Consistent with the requirement that
Federal assistance is supplemental, any
Federal funds provided under the Stafford
Act for Public Assistance will be limited to
75 percent of the total eligible costs. In order
to provide Federal assistance, you are hereby
authorized to allocate from funds available
for these purposes such amounts as you find
necessary for Federal emergency assistance
and administrative expenses.
Further, you are authorized to make
changes to this declaration for the approved
assistance to the extent allowable under the
Stafford Act.
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The Federal Emergency Management
Agency (FEMA) hereby gives notice that
pursuant to the authority vested in the
Administrator, Department of Homeland
Security, under Executive Order 12148,
as amended, Gregory W. Eaton, of
FEMA is appointed to act as the Federal
Coordinating Officer for this declared
emergency.
The following areas of the State of
Oklahoma have been designated as
adversely affected by this declared
emergency:
All 77 counties of the State of Oklahoma
for emergency protective measures (Category
B), limited to direct Federal assistance, under
the Public Assistance program.
The following Catalog of Federal Domestic
Assistance Numbers (CFDA) are to be used
for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora
Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034,
Disaster Unemployment Assistance (DUA);
97.046, Fire Management Assistance Grant;
97.048, Disaster Housing Assistance to
Individuals and Households In Presidentially
Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance—
Disaster Housing Operations for Individuals
and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals
and Households—Other Needs; 97.036,
Disaster Grants—Public Assistance
(Presidentially Declared Disasters); 97.039,
Hazard Mitigation Grant.
W. Craig Fugate,
Administrator, Federal Emergency
Management Agency.
[FR Doc. 2010–2798 Filed 2–8–10; 8:45 am]
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DEPARTMENT OF THE INTERIOR
Bureau of Indian Affairs
Information Collection for Energy and
Mineral Development Program Grants;
Comment Request
AGENCY: Bureau of Indian Affairs,
Interior.
ACTION: Notice of Submission to the
Office of Management and Budget.
SUMMARY: The Bureau of Indian Affairs
(BIA) is submitting the new information
collection on the Energy and Mineral
Development Program Grants for review
and approval as required by the
Paperwork Reduction Act. The Office of
Management and Budget (OMB) will
assign a Control Number.
DATES: Submit comments on or before
March 11, 2010.
ADDRESSES: You may submit comments
on the information collection to the
Desk Officer for Department of the
Interior at the Office of Management and
Budget, by facsimile to (202) 395–5806
or you may send an e-mail to:
OIRA_DOCKET@ omb.eop.gov. Please
send a copy of your comments to Darryl
Francois, Department of the Interior,
Office of Indian Energy and Economic
Development, Room 20, South Interior
Building, 1951 Constitution Avenue,
NW., Washington, DC 20245, fax (202)
208–4564; e-mail:
Darryl.Francois@bia.gov.
FOR FURTHER INFORMATION CONTACT: You
may request further information or
obtain copies of the information
collection request submission from
Darryl Francois, Department of the
Interior, Office of Indian Energy and
Economic Development. Telephone
(202) 219–0740.
SUPPLEMENTARY INFORMATION:
I. Abstract
The Energy Policy Act of 2005
authorizes the Secretary of the Interior
to provide grants to Indian tribes for
energy development. See 25 U.S.C.
3502. The Office of Indian Energy and
Economic Development (IEED)
administers and manages the Energy
and Minerals Development Program
(EMDP). Congress appropriates funds to
EMDP on a year-to-year basis. When
funding is available, IEED may solicit
proposals for energy and mineral
development projects from Indian tribes
whose lands are held in trust or
restricted fee by the Federal
government. Tribes may use the
contracting mechanism established by
the Indian Self-Determination Act or
may receive the grant money through
adjustments to their funding from the
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6405
Office of Self-Governance. See 25 U.S.C.
450 et seq. The projects may be in the
areas of exploration, assessment,
development, feasibility, or market
studies. Indian tribes that would like to
apply for an EMDP grant must submit
an application that includes certain
information, and must assist IEED by
providing information in support of any
National Environmental Policy Act
(NEPA) analyses. A complete
application must contain the following
elements.
• A current, signed tribal resolution
that: (1) Authorizes the energy and
mineral development project for the
appropriate fiscal year; (2) describes
the commodity or commodities to
be studied; (3) states that the tribe
is willing to consider developing
any potential energy or mineral
resources discovered; (4) describes
how the tribe prefers to have the
energy or mineral program
conducted (i.e., through the sole
utilization of IEED in-house
professional staff, in conjunction
with professional tribal staff,
through private contractors, or
through other appropriate means);
and (5) states that the tribe will
consider public release of
information obtained from the
energy and mineral development
study upon request from IEED.
• A proposal describing the planned
activities and deliverable products
that will be accomplished within
the fiscal year for which funding is
requested, including:
Æ Overview, including the elements
of the proposed study, reasons why
the proposed study is needed, total
requested funding, responsible
parties for technical exaction and
administration, and tribal point of
contact for the project;
Æ Technical summary of the project,
including whether the request will
begin a new study or continue a
study and the duration of the study,
a description of any known energy
and/or mineral deposit, reference to
any existing mineral exploration
information, and a description of
any environmental or cultural
sensitive areas;
Æ Project objective, goals and scope of
work;
Æ Deliverable products, such as
technical data and maps; and
Æ Resumes of key personnel.
• A detailed budget estimate, including
contracted personnel costs, travel
estimates, data collection and
analysis costs, and other expenses.
The IEED requires this information to
ensure that it provides funding only to
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Agencies
[Federal Register Volume 75, Number 26 (Tuesday, February 9, 2010)]
[Notices]
[Pages 6404-6405]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-2798]
=======================================================================
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DEPARTMENT OF HOMELAND SECURITY
Federal Emergency Management Agency
[Internal Agency Docket No. FEMA-3308-EM; Docket ID FEMA-2010-0002]
Oklahoma; Emergency and Related Determinations
AGENCY: Federal Emergency Management Agency, DHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of Oklahoma (FEMA-3308-EM), dated January 30,
2010, and related determinations.
DATES: Effective Date: January 30, 2010.
FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472, (202) 646-3886.
SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated January 30, 2010, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:
I have determined that the emergency conditions in certain areas
of the State of Oklahoma resulting from a severe winter storm
beginning on January 28, 2010, and continuing, are of sufficient
severity and magnitude to warrant an emergency declaration under the
Robert T. Stafford
[[Page 6405]]
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq.
(``the Stafford Act''). Therefore, I declare that such an emergency
exists in the State of Oklahoma.
You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), limited to direct Federal assistance, under the Public
Assistance program. This assistance excludes regular time costs for
subgrantees' regular employees.
Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, Gregory
W. Eaton, of FEMA is appointed to act as the Federal Coordinating
Officer for this declared emergency.
The following areas of the State of Oklahoma have been designated
as adversely affected by this declared emergency:
All 77 counties of the State of Oklahoma for emergency
protective measures (Category B), limited to direct Federal
assistance, under the Public Assistance program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-2798 Filed 2-8-10; 8:45 am]
BILLING CODE 9111-23-P