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 

mstockstill on DSKH9S0YB1PROD with NOTICES

38656 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 

faculty at the DISL are actively involved 

in both basic and applied research in 

coastal waters of the northern Gulf of 

Mexico. The DISL operates marine 

research vessels (boats) crewed by 

faculty and students for field studies 

and sample collections. DISL possesses 

extensive laboratory and wet-laboratory 

resources relevant to the mission of the 

FDA/GCSL. The DISL is located within 

1 mile of the FDA/GCSL which will 

engage the proposed program of 

collaboration and internships. This 

unique circumstance of capability, 

capacity and proximity is irreplaceable 

without extended and costly 

concessions. 

II. Award Information/Funds Available 

A. Award Amount 

The estimated amount of support in 

FY09 will be up to $250,000 total costs 

(direct plus indirect costs). 

B. Length of Support 

The award will provide 12 months of 

support contingent upon satisfactory 

performance in the achievement of 

project and program reporting. 

III. Paper Application, Registration, 

and Submission Information 

To submit a paper application in 

response to this FOA, applicants should 

first review the full announcement 

located at http://www.cfsan.fda.gov/ 

list.html. Persons interested in applying 

for a grant may obtain an application 

from the PHS 398 application 

instructions available at http:// 

grants.nih.gov/grants/forms.htm. The 

following steps are required for paper 

submission: 

• Step 1: Obtain a Dun and Bradstreet 

Number (DUNS) 

Applicants are now required to have 

a DUNS number to apply for a grant or 

cooperative agreement from the Federal 

Government. The DUNS number is a 9- 

digit identification number that 

uniquely identifies business entities. To 

obtain a DUNS number, call DUN and 

Bradstreet at 1–866–705–5711. Be 

certain that you identify yourself as a 

Federal grant applicant when you 

contact Dun and Bradstreet. For foreign 

entities the Web site https:// 

eupdate.DNB.com. 

• Step 2: Register With Central 

Contractor Registration (CCR) 

Applicants must register with the CCR 

database. You must have a DUNS 

number to begin your registration. This 

database is a government-wide 

warehouse of commercial and financial 

information for all organizations 

conducting business with the Federal 

Government. The preferred method for 

completing a registration is through the 

Web site at https://www.ccr.gov. This 

Web site provides a CCR handbook with 

detailed information on data you will 

need prior to beginning the online preregistration, as well as steps to walk you 

through the registration process. 

• Step 3: Register With Electronic 

Research Administration (eRA) 

Commons 

Steps 1 and 2, in detail, can be found 

at http://www07.grants.gov/applicants/ 

organization_registration.jsp. Step 3, in 

detail, can be found at https:// 

commons.era.nih.gov/commons/ 

registration/registrationInstructions.jsp. 

After you have followed these steps, 

submit paper applications to: Camille 

Peake, Division of Acquisition Support 

and Grants, Food and Drug 

Administration (HFA 500), 5630 Fishers 

Lane, rm. 2139, Rockville, MD 20857, 

301–827–7175, FAX: 301–827–7101, email: Camille.Peake@fda.hhs.gov. 

Dated: July 28, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–18533Filed 8–3–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0582] 

Kim C. Hendrick: Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the act) permanently 

debarring Kim C. Hendrick, M.D., from 

providing services in any capacity to a 

person that has an approved or pending 

drug product application. We base this 

order on a finding that Dr. Hendrick was 

convicted of a felony under Federal law 

for conduct relating to the development 

or approval, including the process for 

development or approval, of a drug 

product, and for conduct otherwise 

relating to the regulation of a drug 

product under the act. After being given 

notice of the proposed permanent 

debarment and an opportunity to 

request a hearing within the timeframe 

prescribed by regulation, Dr. Hendrick 

failed to request a hearing. Dr. 

Hendrick’s failure to request a hearing 

constitutes a waiver of his right to a 

hearing concerning this action. 

DATES: This order is effective August 4, 

2009. 

ADDRESSES: Submit applications for 

special termination of debarment to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Robert Hummel, Sr., Division of 

Compliance Policy (HFC–230), Office of 

Enforcement, Office of Regulatory 

Affairs, Food and Drug Administration, 

5600 Fishers Lane, Rockville, MD 

20857, 240–632–6845. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(a)(2)(A) of the act (21 

U.S.C. 335a(a)(2)(A)) requires debarment 

of an individual if FDA finds that the 

individual has been convicted of a 

felony under Federal law for conduct 

relating to the development or approval, 

including the process for development 

or approval, of any drug product. 

Section 306(a)(2)(B) of the act requires 

debarment of an individual if FDA finds 

that the individual has been convicted 

of a felony under Federal law for 

conduct otherwise relating to the 

regulation of any drug product under 

the act. 

On September 11, 2007, the U.S. 

District Court for the Eastern District of 

Michigan accepted Dr. Hendrick’s guilty 

plea and entered judgment against him 

for one count of mail fraud, a federal 

felony offense under 18 U.S.C. 1341. 

This offense was committed when Dr. 

Hendrick was a licensed physician 

practicing medicine in the State of 

Michigan. Dr. Hendrick agreed to 

participate in the clinical research trial 

for Augmentin XR, including its use in 

the treatment of adults with Acute 

Bacterial Sinusitis (ABS). As part of his 

participation in the clinical study, he 

agreed to conduct the study in 

conformity with the protocol 

established by GlaxoSmithKline and to 

comply with FDA regulations. He also 

agreed to take X-rays, before and after 

treatment, of persons he diagnosed with 

ABS, and to have an independent 

radiologist analyze these and issue 

reports regarding the X-rays. 

Dr. Hendrick admitted that instead of 

having an independent radiologist 

review the X-rays and issue reports, he 

allowed certain X-rays to be sent in 

batch form, which was a direct violation 

of the protocol. Further, he did not 

verify the purported signatures of the 

independent radiologist reports and, 

instead, failed to disclose to 

GlaxoSmithKline and/or FDA that the 

signatures were unverified and possibly 

mstockstill on DSKH9S0YB1PROD with NOTICES