Food and Drug Administration (FDA) and Marine Environmental Sciences Consortium/Dauphin Island Sea Lab Collaboration (U19), 38666-38667 [2011-16627]
Download as PDF
38666
Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Notices
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
No. of responses per
respondent
No. of respondents
Activity
Total annual
responses
Average burden per response
Total hours
Main Study ...........................................................................
8,000
1
8,000
.33 (20 min.)
2,640
Total ..............................................................................
........................
........................
........................
........................
3,320
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Grants Management Contact
Gladys Melendez-Bohler, Office of
Acquisition and Grant Services (OAGS),
Food and Drug Administration, 5630
Fishers Lane, rm. 1078, Rockville, MD
20857, Tele.: 301–827–7175; e-mail:
Gladys-Melendez-Bohler@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.fda.gov/Food/NewsEvents/
default.htm.
[FR Doc. 2011–16628 Filed 6–30–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0012]
Food and Drug Administration (FDA)
and Marine Environmental Sciences
Consortium/Dauphin Island Sea Lab
Collaboration (U19)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
mstockstill on DSK4VPTVN1PROD with NOTICES6
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of grant funds for the
support of a cooperative agreement
between the Center for Food Safety and
Applied Nutrition (CFSAN) and the
Marine Environmental Sciences
Consortium/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
1, 2011.
2. The anticipated start date is
September, 2011.
3. The opening date is the date the
Funding Opportunity is published in
the Federal Register.
4. The expiration date is August 2,
2011.
FOR FURTHER INFORMATION AND
ADDITIONAL REQUIREMENTS CONTACT:
Scientific/Programmatic Contact
Robert Dickey, Office of Food Safety,
Gulf Coast Seafood Laboratory, One
Iberville Dr., PO. D1–1, rm. 122 (HFS
400), Dauphin Island, AL 36528,. Tele.:
251–690–3368; e-mail:
Robert.Dickeyr@fda.hhs.gov.
VerDate Mar<15>2010
18:54 Jun 30, 2011
Jkt 223001
SUPPLEMENTARY INFORMATION:
RFA–FD–11–015; 93.103.
A. Background
This FOA issued by the FDA/Office of
Food Safety is soliciting a sole source
grant application from the Dauphin
Island Sea Lab (DISL). FDA is
authorized to enforce the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
as amended (21 U.S.C. 301 et seq.). In
fulfilling its responsibilities under the
FD&C 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’s
nationally ranked programs, leadingedge 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
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
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
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
E:\FR\FM\01JYN1.SGM
01JYN1
Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Notices
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 ongoing
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
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.
first review the full announcement
located at https://www.fda.gov/Food/
NewsEvents/default.htm. (FDA has
verified the Web site addresses
throughout this document, but FDA is
not responsible for any subsequent
changes to the Web sites after this
document publishes in the Federal
Register.) Persons interested in applying
for a grant may obtain an application at
https://grants2.nih.gov/grants/funding/
phs398/phs398.html. For all paper
application submissions, the following
steps are required:
• Step 1: Obtain a Dun and Bradstreet
Data Universal Numbering System
(DUNS) Number.
• Step 2: Register With Central
Contractor Registration.
• 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:
Gladys Melendez-Bohler, Office of
Acquisition and Grant Services (OAGS),
Food and Drug Administration, 5630
Fishers Lane, rm. 1078, Rockville, MD
20857.
Dated: June 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–16627 Filed 6–30–11; 8:45 am]
BILLING CODE 4160–01–P
II. Award Information/Funds Available
mstockstill on DSK4VPTVN1PROD with NOTICES6
A. Award Amount
The estimated amount of support in
FY12 will be up to $125,000. (direct
plus indirect costs) with the possibility
of 4 additional years of support for up
to $125,000.00 per year, subject to the
availability of funds. Future year
amounts will depend on annual
appropriations and successful contract
performance.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
B. Length of Support
The award will provide 1 year of
support and include future
recommended support for 4 additional
years, contingent upon satisfactory
performance in the achievement of
project and program reporting objectives
during the preceding year and the
availability of Federal fiscal year
appropriations.
HHS.
III. Paper Application, Registration,
and Submission Information
To submit a paper application in
response to this FOA, applicants should
VerDate Mar<15>2010
18:54 Jun 30, 2011
Jkt 223001
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Transmissible Spongiform
Encephalopathies Advisory
Committee; Notice of Meeting
AGENCY:
ACTION:
Food and Drug Administration,
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Transmissible
Spongiform Encephalopathies Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
38667
Date and Time: The meeting will be
held on August 1, 2011, from 9 a.m. to
approximately 4:30 p.m.
Location: Hilton Hotel, Washington
DC North Gaithersburg, 620 Perry
Pkwy., Gaithersburg, MD 20877. For
those unable to attend in person, the
meeting will also be Web cast. The Web
cast will be available at the following
link. Transmissible Spongiform
Encephalopathies Advisory Committee
https://fda.yorkcast.com/webcast/
Viewer/?peid=8477143b2da5442a
8192731eccde3b7a1d.
CONTACT PERSON: Bryan Emery or
Rosanna Harvey, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
301–827–0314, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: The committee will discuss
donor deferral for time spent in Saudi
Arabia to reduce the risk of variant
Creutzfeldt-Jakob disease (vCJD) by
blood and blood products and human
cells, tissues and cellular and tissuebased products.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before July 25, 2011. Oral
presentations from the public will be
scheduled on August 1, 2011, between
approximately 2:15 p.m. and 2:45 p.m.
E:\FR\FM\01JYN1.SGM
01JYN1
Agencies
[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]
[Notices]
[Pages 38666-38667]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16627]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0012]
Food and Drug Administration (FDA) and Marine Environmental
Sciences Consortium/Dauphin Island Sea Lab Collaboration (U19)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds for the support of a cooperative agreement
between the Center for Food Safety and Applied Nutrition (CFSAN) and
the Marine Environmental Sciences Consortium/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 1, 2011.
2. The anticipated start date is September, 2011.
3. The opening date is the date the Funding Opportunity is
published in the Federal Register.
4. The expiration date is August 2, 2011.
For Further Information and Additional Requirements Contact:
Scientific/Programmatic Contact
Robert Dickey, Office of Food Safety, Gulf Coast Seafood
Laboratory, One Iberville Dr., PO. D1-1, rm. 122 (HFS 400), Dauphin
Island, AL 36528,. Tele.: 251-690-3368; e-mail:
Robert.Dickeyr@fda.hhs.gov.
Grants Management Contact
Gladys Melendez-Bohler, Office of Acquisition and Grant Services
(OAGS), Food and Drug Administration, 5630 Fishers Lane, rm. 1078,
Rockville, MD 20857, Tele.: 301-827-7175; e-mail: Gladys-Melendez-Bohler@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.fda.gov/Food/NewsEvents/default.htm.
SUPPLEMENTARY INFORMATION:
RFA-FD-11-015; 93.103.
A. Background
This FOA issued by the FDA/Office of Food Safety is soliciting a
sole source grant application from the Dauphin Island Sea Lab (DISL).
FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) as amended (21 U.S.C. 301 et seq.). In fulfilling its
responsibilities under the FD&C 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's 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
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
[[Page 38667]]
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 ongoing 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 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 FY12 will be up to $125,000.
(direct plus indirect costs) with the possibility of 4 additional years
of support for up to $125,000.00 per year, subject to the availability
of funds. Future year amounts will depend on annual appropriations and
successful contract performance.
B. Length of Support
The award will provide 1 year of support and include future
recommended support for 4 additional years, contingent upon
satisfactory performance in the achievement of project and program
reporting objectives during the preceding year and the availability of
Federal fiscal year appropriations.
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.fda.gov/Food/NewsEvents/default.htm. (FDA has verified the Web site
addresses throughout this document, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.) Persons interested in applying for a grant may
obtain an application at https://grants2.nih.gov/grants/funding/phs398/phs398.html. For all paper application submissions, the following steps
are required:
Step 1: Obtain a Dun and Bradstreet Data Universal
Numbering System (DUNS) Number.
Step 2: Register With Central Contractor Registration.
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:
Gladys Melendez-Bohler, Office of Acquisition and Grant Services
(OAGS), Food and Drug Administration, 5630 Fishers Lane, rm. 1078,
Rockville, MD 20857.
Dated: June 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-16627 Filed 6-30-11; 8:45 am]
BILLING CODE 4160-01-P