38654 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 

1FDA 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. 

3The 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. 5Please 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: 

Grantee organization Location Amount of award 

Catholic Social Services ......................................................................................... Anchorage, AK ....................................... $86,931 

Colorado Department of Human Services .............................................................. Denver, CO ............................................ 798,411 

Catholic Charities of Louisville ................................................................................ Louisville, KY ......................................... 575,000 

Catholic Charities Diocese of Baton Rouge ........................................................... Baton Rouge, LA ................................... 94,368 

Massachusetts Office of Refugees and ..................................................................

Immigrants ..............................................................................................................

Boston, MA ............................................ 189,823 

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: 

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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

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: 

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– 

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 http:// 

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: 

I. Funding Opportunity Description 

[RFA-FD–09–017] 

[Catalog of Federal Domestic Assistance 

Number: 93.103] 

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 

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 

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