Administration for Children and Families; Office of Refugee Resettlement, 38654-38655 [E9-18521]
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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
G. CDC and the appropriate state and/or local public health authority(ies) are also authorized to make available additional information relating to the emergency use of authorized oseltamivir phosphate products that is consistent with, and does not exceed, the terms of this letter of authorization.
The emergency use of authorized oseltamivir phosphate products as described in this letter of authorization must comply with the
conditions above and all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.
Joshua M. Sharfstein, M.D.
Principal Deputy Commissioner
Acting Commissioner of Food and Drugs
1 FDA is authorizing the emergency use of Tamiflu (oseltamivir phosphate) (30 mg, 45 mg, and 75 mg) capsules and oral suspension for treatment and prophylaxis of influenza as described in the scope section of this letter (Section II). For ease of reference, this
letter of authorization will use the terms ‘‘certain oseltamivir phosphate product(s)’’ and ‘‘authorized oseltamivir phosphate product(s).’’
2 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
2 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
3 The following points should be considered before initiating treatment or prophylaxis with oseltamivir phosphate products.
Oseltamivir phosphate products are not a substitute for early vaccination on an annual basis as recommended by the Centers for
Disease Control and Prevention Advisory Committee on Immunization Practices. Influenza viruses change over time. Emergence of
resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish
clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate products.
4 It is possible that public health officials or other volunteers might distribute authorized oseltamivir phosphate products to recipients, if permitted, in accordance with applicable state and local law and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the covered countermeasures, and their officials, agents, employees, contractors, or volunteers following a declaration of an emergency. For ease of reference, this letter will use the term ‘‘health care provider(s)’’ to refer collectively to these individuals.
5 Please note that with respect to authorized oseltamivir phosphate products for use in patients less than 1 year old, the conclusions above are based on limited data available for review under the limited timeframe given the circumstances of the emergency.
The conclusions above may evolve as the emergency circumstances evolve and as more information becomes available.
(Please note that certain written
emergency use information was also
amended).
Dated: June 30, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–18568 Filed 8–3–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families; Office of Refugee
Resettlement
AGENCY: Office of Refugee Resettlement,
ACF, HHS.
ACTION: Notice to Award Five Program
Expansion Supplements to Wilson-Fish
Projects.
CFDA Number: 93.583.
Legislative Authority: The Refugee Act
of 1980 as amended, Wilson-Fish
Amendment, 8 U.S.C. 1522(e)(7);
section 412(e)(7)(A) of the Immigration
and Nationality Act.
Amount of Award: $1,744,533.
Period Of Support: 09/30/2009–09/
29/2010.
SUMMARY: The Office of Refugee
Resettlement (ORR) announces the
award of program expansion
supplements to five Wilson-Fish
Program grantees. The Wilson-Fish
Program is an alternative to traditional
State-administered refugee assistance
programs and provides integrated
assistance and services to refugees,
asylees, Amerasian Immigrants, Cuban
and Haitian Entrants, Trafficking
Victims and Iraqi/Afghani Special
Immigrant Visas (SIVs). The five
supplemental awards will allow the
grantees to provide cash and medical
assistance to arriving refugees and to
others who are also eligible for refugee
benefits through the remainder of Fiscal
Year (FY) 2009. The expansion
supplement awards will enable the
grantees to provide services needed to a
higher number of arrivals than
originally planned. The Refugee Act of
1980 mandates that the ORR reimburse
State agencies and Wilson-Fish projects
for the costs of cash and medical
assistance for newly arriving refugees.
Since 1991, ORR has reimbursed State
agencies and Wilson-Fish agencies for
providing cash and medical assistance
to eligible individuals during their first
eight months in the United States. The
following Wilson-Fish Program grantees
are awarded program expansion
supplemental funding:
mstockstill on DSKH9S0YB1PROD with NOTICES
Grantee organization
Location
Catholic Social Services .........................................................................................
Colorado Department of Human Services ..............................................................
Catholic Charities of Louisville ................................................................................
Catholic Charities Diocese of Baton Rouge ...........................................................
Massachusetts Office of Refugees and ..................................................................
Immigrants ..............................................................................................................
Anchorage, AK .......................................
Denver, CO ............................................
Louisville, KY .........................................
Baton Rouge, LA ...................................
Boston, MA ............................................
FOR FURTHER INFORMATION CONTACT:
Carl
Rubenstein, Wilson-Fish Program
VerDate Nov<24>2008
17:11 Aug 03, 2009
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Manager, Office of Refugee
Resettlement, Aerospace Building, 8th
PO 00000
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Amount of award
$86,931
798,411
575,000
94,368
189,823
Floor West, 901 D Street SW.,
Washington, DC 20447. Telephone:
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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
7175, FAX: 301–827–7101, e-mail:
Camille.Peake@fda.hhs.gov.
For more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
refer to the full FOA located at https://
www.cfsan.fda.gov/list.html. Click on
National Food Safety Program; click
www.Food Safety.gov; click search and
site index; search on ‘‘CFSAN Grants.’’
SUPPLEMENTARY INFORMATION:
202–205–5933 E-mail:
crubenstein@acf.hhs.gov.
Dated: July 27, 2009.
Eskinder Negash,
Director, Office of Refugee Resettlement.
[FR Doc. E9–18521 Filed 8–3–09; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
I. Funding Opportunity Description
[RFA-FD–09–017]
[Catalog of Federal Domestic Assistance
Number: 93.103]
Food and Drug Administration
[Docket No. FDA–2009–N–0353]
Cooperative Agreement Between the
Food and Drug Administration and the
Dauphin Island Sea Lab
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing its
intention to receive and consider a
single source application for the award
of a cooperative agreement in fiscal year
2009 (FY09) to the Dauphin Island Sea
Lab (DISL). The goal of the DISL is
marine science education, basic and
applied marine science research, coastal
zone management policy and educating
the general public.
DATES: Important dates are as follows:
1. The application due date is August
24, 2009.
2. The anticipated start date is in
September 2009.
3. The opening date is August 3, 2009.
4. The expiration date is August 25,
2009.
FOR FURTHER INFORMATION AND
ADDITIONAL REQUIREMENTS CONTACT:
mstockstill on DSKH9S0YB1PROD with NOTICES
Center Contact: LaQuia Geathers,
Center for Food Safety and Applied
Nutrition (CFSAN) (HFS–669),
Food and Drug Administration
(FDA), 5100 Paint Branch, Pkwy.,
College Park, MD 20740, 301–436–
2821, e-mail:
LaQuia.Geather@fda.hhs.gov.
Scientific/Programmatic Contact:
Julia Pryor, Division of Seafood
Science and Technology, FDA,
CFSAN, Office of Food Safety, Gulf
Coast Seafood Laboratory, 1
Iberville Dr., Dauphin Island, AL
36528, 251–694–4479; FAX: 251–
694–4477, e-mail:
Julia.Pryor@fda.hhs.gov.
Grants Management Contact: Camille
Peake, Division of Acquisition
Support and Grants, FDA (HFA
500), 5630 Fishers Lane (rm. 2139),
Rockville, MD 20857, 301–827–
VerDate Nov<24>2008
16:07 Aug 03, 2009
Jkt 217001
A. Background
This FOA issued by the Office of Food
Safety is soliciting a sole source grant
application from the DISL. FDA is
authorized to enforce the Federal Food,
Drug, and Cosmetic Act (the act) as
amended (21 U.S. C. 301 et seq.). In
fulfilling its responsibilities under the
act, FDA among other things, directs its
activities toward promoting and
protecting the public health by ensuring
the safety and security of foods
(Appendix A). To accomplish its
mission, FDA must stay abreast of the
latest developments in research and also
communicate with stakeholders about
complex scientific and public health
issues. Increased development of
research, education and outreach
partnerships with the Marine
Environmental Science ConsortiumDauphin Island Sea Lab (DISL) will
greatly contribute to FDA’s mission.
The DISL is one of Alabama’s most
valuable assets and adds immeasurably
to the quality of life in the State and
beyond. The DISL network of 21
institutions enrolls students worldwide
in degree programs delivered in
classrooms, laboratories, education
centers and online. The DISL nationally
ranked programs, leading-edge research
collaborations, and innovative business
partnerships provide an environment to
support diverse multidisciplinary
exchanges with FDA. The scientific,
public health and policy expertise
within FDA provide opportunities for
collaborations that support the DISL
mission and strategic themes to provide
access to high-quality education,
research discovery, and knowledgebased services responsive to both the
promises and demands of the state and
the nation in the new century.
B. Research Objectives
The FDA Gulf Coast Seafood
Laboratory (GCSL) and the Marine
Environmental Science Consortium of
the DISL (the Parties) have a shared
interest in scientific progress in the
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38655
diverse disciplines that directly and
indirectly affect seafood safety and
human and animal health. The Parties
also endorse scientific training for
faculty, students and staff to foster a
well-grounded foundation in
interdisciplinary fields in which
academia and government share mutual
interest.
The cooperative agreement will
establish terms of collaboration between
FDA and DISL to support these shared
interests that can be pursued through
programs of collaborative research,
public outreach, cooperative
international initiatives, disciplinary
training, and exchange of scientists and
staff, including a program of graduate
student internships.
The types of activities expected to
develop from this agreement include:
• Exchanges between university
faculty and staff and FDA scientists and
staff;
• Educational opportunities for
qualified students (graduate), staff
members and faculty members in the
Parties’ laboratories, classroom and
offices;
• Joint meetings for education and
research;
• Research collaborations;
• Cooperative international activities
including outreach; and
• Sharing of unique facilities and
equipment for increased cost
efficiencies for scientific endeavors;
• Promulgation and communication
of identified collaborative efforts
through appropriate means;
• Adjunct, affiliates and research
facility appointments for appropriate
FDA professional staff, provided that
appointment of such candidates will
advance specific programmatic
objectives of the parties as appropriate,
and provided that such appointments
comply with university policies on
appointment of facility/affiliates;
• In an effort to enhance collaborative
interactions and communication
between both institutions, FDA and
DISL will collaborate in the
development of regular workshops
where faculty from all the institutions
within the DISL and FDA scientists and
staff share information about on going
research, education and outreach efforts
of mutual interest.
C. Eligibility Information
Competition is limited to the DISL.
There are no other sources that can
provide the required proximity to the
FDA/GCSL and independent marine
fieldwork capability required. The DISL
is a diverse institutional consortium of
undergraduate and graduate education
and research. University programs
E:\FR\FM\04AUN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 148 (Tuesday, August 4, 2009)]
[Notices]
[Pages 38654-38655]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18521]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families; Office of Refugee
Resettlement
AGENCY: Office of Refugee Resettlement, ACF, HHS.
ACTION: Notice to Award Five Program Expansion Supplements to Wilson-
Fish Projects.
-----------------------------------------------------------------------
CFDA Number: 93.583.
Legislative Authority: The Refugee Act of 1980 as amended, Wilson-
Fish Amendment, 8 U.S.C. 1522(e)(7); section 412(e)(7)(A) of the
Immigration and Nationality Act.
Amount of Award: $1,744,533.
Period Of Support: 09/30/2009-09/29/2010.
SUMMARY: The Office of Refugee Resettlement (ORR) announces the award
of program expansion supplements to five Wilson-Fish Program grantees.
The Wilson-Fish Program is an alternative to traditional State-
administered refugee assistance programs and provides integrated
assistance and services to refugees, asylees, Amerasian Immigrants,
Cuban and Haitian Entrants, Trafficking Victims and Iraqi/Afghani
Special Immigrant Visas (SIVs). The five supplemental awards will allow
the grantees to provide cash and medical assistance to arriving
refugees and to others who are also eligible for refugee benefits
through the remainder of Fiscal Year (FY) 2009. The expansion
supplement awards will enable the grantees to provide services needed
to a higher number of arrivals than originally planned. The Refugee Act
of 1980 mandates that the ORR reimburse State agencies and Wilson-Fish
projects for the costs of cash and medical assistance for newly
arriving refugees. Since 1991, ORR has reimbursed State agencies and
Wilson-Fish agencies for providing cash and medical assistance to
eligible individuals during their first eight months in the United
States. The following Wilson-Fish Program grantees are awarded program
expansion supplemental funding:
------------------------------------------------------------------------
Grantee organization Location Amount of award
------------------------------------------------------------------------
Catholic Social Services........ Anchorage, AK..... $86,931
Colorado Department of Human Denver, CO........ 798,411
Services.
Catholic Charities of Louisville Louisville, KY.... 575,000
Catholic Charities Diocese of Baton Rouge, LA... 94,368
Baton Rouge.
Massachusetts Office of Refugees Boston, MA........ 189,823
and.
Immigrants......................
------------------------------------------------------------------------
FOR FURTHER INFORMATION CONTACT: Carl Rubenstein, Wilson-Fish Program
Manager, Office of Refugee Resettlement, Aerospace Building, 8th Floor
West, 901 D Street SW., Washington, DC 20447. Telephone:
[[Page 38655]]
202-205-5933 E-mail: crubenstein@acf.hhs.gov.
Dated: July 27, 2009.
Eskinder Negash,
Director, Office of Refugee Resettlement.
[FR Doc. E9-18521 Filed 8-3-09; 8:45 am]
BILLING CODE 4184-01-P
