E6-14109. National Center for Natural Products Research, University of Mississippi; Single Source Cooperative Agreement; Catalog of Federal Domestic Assistance Number 93.103; Request for Application

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

I. Funding Opportunity Description

The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source competing continuation application for the award of a cooperative agreement in fiscal year (FY 2006) to the University of Mississippi (UM) to support the National Center for Natural Products Research (NCNPR), which is located on UM's Campus at Oxford, MS, for up to $2.3 million for FY06 (direct plus indirect costs combined), the total amount being subject to annual budget appropriations. The funds will provide additional support to the UM's NCNPR for the purpose of promoting more efficient development and dissemination of natural products research and science and will complement the diverse activities of both the public and private sectors that may become collaborators.

Subject to the availability of Federal funds and successful performance, 4 additional years of support will be available. FDA will support the research covered by this notice under the authority of section 301 of the Public Health Service (PHS) Act (42 U.S.C. 241). FDA's research program is described in the Catalog of Federal Domestic Assistance No.93.103. Before entering into cooperative agreements, FDA carefully considers the benefits such agreements will provide to the public.

II. Eligibility Information

FDA believes that there is compelling evidence that UM is uniquely qualified to fulfill the objectives of the proposed cooperative agreement. UM is a comprehensive research institution with numerous academic programs relevant to FDA's mission and the resources to support the Center for Food Safety and Nutrition's (CFSAN's) areas of interest.

NCNPR, which opened in July 1995, is a division of the Research Institute of Pharmaceutical Sciences of UM's School of Pharmacy. NCNPR was created to bring together an alliance of academia, government, and industry to integrate research, development, and commercialization of potentially useful natural products.

The goal of NCNPR in botanical dietary supplements is to enable safe, effective, and proper use of high quality botanical products by informed professionals and consumers. NCNPR conducts basic and applied multidisciplinary research to discover and develop natural products for use as dietary supplements. NCNPR also maintains a repository of several thousand natural product extracts that are available for screening by collaborators working in other areas.

NCNPR has substantial expertise to carry forward specific discoveries, products, and technologies. Most of the projects to develop promising high priority products or technology are conducted in collaboration with industrial partners or through externally funded grants and contract. NCNPR is staffed with a highly synergistic mix of full-time research faculty and support staff and employs a number of undergraduate and graduate students and postdoctoral scientists. Together, the faculty, scientists, staff, students, and external collaborators, provide the human resources required to accomplish the research and development goals of NCNPR.

Collaboration between the public and private sector is an efficient means for both FDA and the University to remain current with scientific and technical accomplishments from a natural products research perspective. Harmonizing research activities is but one example of the need for and use of this natural products research knowledge and expertise. The partnership between FDA and UM will provide both the technical and educational expertise necessary for effective mechanisms that will facilitate the movement of new technology and provide direct usefulness to FDA's scientific and enforcement initiatives.

As of October 1, 2003, applicants are required to have a Dun and Bradstreet Number (DUNS) to apply for a grant or cooperative agreement from the Federal Government. The DUNS number is a 9-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, applicants should go to http://www.grants.gov/​RequestaDUNS or call 1-866-705-5711. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.)

III. Application and Submission

To comply with the President's Management Agenda, HHS is participating as a partner in the new government-wide Grants.gov Web site. Users of Grants.gov will be able to download a copy of the application package, complete it offline, and then upload and submit the application via the Grants.gov Web site. We encourage applicant submission through Grants.gov. If submitted other than electronically, please contact Gladys M. Bohler for guidance (see contact information in the paragraph that follows).

For further information contact Gladys M. Bohler, Grants Management Specialist, Division of Contracts and Grants Management (HFA-500), Food and Drug Administration, 5630 Fishers Lane, Rockville, MD 20857, 301-827-7168, e-mail: [e-mail]. A copy of the complete Request for Applications (RFA) can also be viewed on FDA's Center for Food Safety and Applied Nutrition Web site at http://www.foodsafety.gov/​nfsg/​fsggrant.html (FDA has verified the Web site and its address but we are not responsible for changes to the Web site or its address after this document publishes in the Federal Register.)

IV. Submission Dates and Times

The application receipt date is September 25, 2006. The application will be accepted from 8 a.m. to 4:30 p.m., Monday through Friday until the established receipt date. The application will be considered received on time if hand delivered to the address noted previously (see section III of this document) before the established receipt date, or sent or mailed by the receipt date as shown by a legible U.S. Postal Service dated postmark or a legible dated receipt from a commercial carrier. Private metered postmarks shall not be acceptable as proof of timely mailing. If not received on time the application will not be considered for review and will be returned to the applicant. (Applicants should note the U.S. Postal Service does not uniformly provide dated postmarks. Before relying on this method, applicants should check with their local post office). Please do not send applications to the Center for Scientific Research (CSR) at the National Institutes of Health (NIH). Any application sent to NIH/CSR that is forwarded to the FDA Grants Management Office and not received in time for orderly processing will be judged non-responsive and returned to the applicant. Currently, FDA is unable to receive applications electronically. The applicant is advised that FDA does not adhere to the page limitations or the type size and line spacing requirements imposed by NIH for its applications.

Dated: August 18, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.