Cooperative Agreement Between the Food and Drug Administration and the Dauphin Island Sea Lab, 38655-38656 [E9-18533Filed]
Download as PDF
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
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
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
04AUN1
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.
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 https://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]
mstockstill on DSKH9S0YB1PROD with NOTICES
III. Paper Application, Registration,
and Submission Information
BILLING CODE 4160–01–S
To submit a paper application in
response to this FOA, applicants should
first review the full announcement
located at https://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 https://
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 9digit 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Nov<24>2008
16:07 Aug 03, 2009
Jkt 217001
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.
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
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
E:\FR\FM\04AUN1.SGM
04AUN1
Agencies
[Federal Register Volume 74, Number 148 (Tuesday, August 4, 2009)]
[Notices]
[Pages 38655-38656]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18533Filed]
-----------------------------------------------------------------------
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 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:
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 Consortium-Dauphin 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 knowledge-based 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
[[Page 38656]]
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 https://
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 https://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 pre-registration, 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 https://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, e-mail: 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