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
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