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August 25, 2006
(Federal Register Notice August 25, 2006)
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 (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.
Congress amended the Federal Food, Drug, and Cosmetic Act (the act) with the passage of the Dietary Supplement Health and Education Act of 1994, to create a regulatory framework for dietary supplements under food provisions of the act. FDA has primary responsibility for ensuring that appropriate regulatory actions are taken against marketed products that: (1) Present an unreasonable or significant risk of illness or injury when used according to label directions or under ordinary conditions of use, or (2) bear labeling that is false or misleading.
In the Federal Register of May 3, 2001, FDA published a request for a single source application for a cooperative agreement to support the University of Mississippi, National Center for Natural Products Research (UM-NCNPR). FDA awarded the cooperative agreement to the UM-NCNPR on September 28, 2001, following the review of the application by an ad hoc panel of experts and subsequent approval by the National Advisory Environmental Health Sciences Council in September 2001.
In the Federal Register of June 20, 2002 (67 FR 42052-42054), FDA published a notice of its intent to noncompetitively supplement the cooperative agreement with UM-NCNPR. FDA awarded the noncompetitive supplement to the cooperative agreement with UM-NCNPR September 29, 2002.
The cooperative agreement between the UM-NCNPR and FDA was established to create a partnership that allows for more efficient use of research resources that identify and analyze specific components in ingredients, including botanical ingredients, thereby enhancing overall public health by ensuring that dietary supplements are safe and their labeling is truthful and not misleading. It also provides opportunities to address important national and international problems in natural products research. The unique need for research in support of dietary supplements, with a specific emphasis on the safety of botanical ingredients, has been one of the key reasons for maintaining a strong research program with UM-NCNPR. UM-NCNPR has been determined to be the only institution with the unique capability of providing a broad range of highly relevant scientific expertise and facilities that are physically co-located and singularly dedicated to natural products research. The UM is a comprehensive research institution with numerous academic programs relevant to natural products which can help to ensure that market products are safe for the American public. NCNPR has the unique capability to bring together diverse scientific expertise on bioactive natural products research from: (1) The UM faculty in the School of Pharmacy including researchers in the Departments of Pharmacognosy, Medicinal Chemistry, Pharmaceutics, Pharmacology and the Research Institute of Pharmaceutical Sciences; (2) research scientists in the U.S. Department of Agriculture/Agricultural Research Service's (USDA/ARS) National Products Utilization Research Unit who are physically co-located and programmatically integrated in the NCNPR; (3) its close academic links and historical collaborations with agriculture and botanical programs and facilities at the UM system; and (4) successful research collaborations with the dietary supplement industry. UM-NCNPR's ability to successfully and uniquely collaborate with FDA is also enhanced by its repository of several thousand natural product extracts and its long history of successful basic and applied multidisciplinary research to discover and develop natural products for use as bioactive ingredients in dietary supplements and pharmaceuticals, and for improving the quality and safety of dietary supplements. Additionally, research in UM-NCNPR is focused on using state-of-the-art knowledge and technology to discover bioactive natural products, develop novel technologies or processes that facilitate the discovery of bioactive natural products, and provide research-based information on plant-derived products with health applications. These programs, facilities, and expertise working in conjunction with FDA scientists are essential for supporting the needs to ensure that sound science is available for ensuring the safety and truthfulness of labeling of marketed dietary supplement products. Finally, the large number of established collaborations among UM-NCNPR scientists and other government agencies, academic organizations, and research institutions further enhance the collaboration in the area of natural products research. The primary focus of the FDA and UM-NCNPR collaboration is to support and benefit the public health by promoting more efficient development and dissemination of natural products research and science and to complement the diverse activities of both the public and private sector that may become collaborators.
FDA believes that cooperative research with the UM-NCNPR will provide opportunities to address important national and international problems in natural products research in a timely manner. However, only FDA employees will perform any official regulatory activities. Further, FDA believes that cooperative research through UM will promote the efficient use of the complementary resources of both parties.
The applicant would propose to design, implement, and evaluate a comprehensive, multidisciplinary array of scientific activities in the broad area of natural products’ ingredients. The applicant’s proposal must be designed to meet the objectives of the request for applications (RFA). The applicant’s proposal should identify and assess innovative approaches to address the RFA objectives relative to the broad area of natural product identification and safety.
The purpose of this cooperative agreement will be to continue to:
The purpose is to augment and enhance research and scientific expertise in natural products research. There is a critical need to address the increasingly complex problems in such areas as acquisition, validation, and characterization of botanical reference materials, related research and literature reviews to ensure the safety or effectiveness of marketed products, and the development of sound scientific principles and consensus-building for dealing with these ingredients and products. Since there is increased concern regarding the safety of dietary supplements, the need to find other ways of expanding the current science base is essential. The sharing of complementary resources will create opportunities for important national and international issues in natural products research to be addressed in a timely and scientifically sound manner. Many of these issues (e.g., development and characterization of authenticated botanical reference standards, and scientific review and consensus-building) can only be addressed with close cooperation of the pubic and private sectors. UM’s expertise and facilities for obtaining and characterizing authenticated botanical reference materials are needed to conduct investigations at the forefront of natural products research. Additionally, UM’s experimental field plots, vast repository containing thousands of natural products extracts for testing in a variety of biological assays, and their expertise and long history of active scientific investigations are well known in these areas. University personnel will provide enhanced scientific expertise in advanced techniques for the characterization of natural products as well as expand the current capabilities in research to support regulatory actions and respond to emergency situations.
FDA believes research conducted at the UM-NCNPR provides a sound investment in the future public health of American consumers. FDA faces an increasing number of critical and complex natural products research issues. Having this valuable source of complementary and specialized scientific expertise and facilities enhances FDA’s ability to respond rapidly to regulatory challenges and to expedite regulatory policy and decisions. It also provides opportunities for extensive cooperation with university scientists; and encourages industry involvement in collaboration and research associated with the safety of botanical dietary supplements. This partnership further stimulates collaborative efforts to ensure a safe food supply contributing significantly to the implementation of the goals for government, academia, industry, and consumers to work together to improve the safety of natural products. The UM-NCNPR scientists bring a special perspective to advancing the knowledge of natural products germane to the public interest. FDA’s participation in this venture will continue to promote a greater awareness and understanding of regulatory science and practice among academic scientists, thereby providing economic and program benefits to both. In summary, collaboration between the public and the private sector provides an efficient means of remaining current with the scientific and technical accomplishments in the areas of natural products research.
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.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and to discourage the use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
FDA is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a national effort designed to reduce morbidity and mortality and to improve quality of life. Applicants may obtain a paper copy of the "Healthy People 2010" objectives, vols. I and II, for $70 ($87.50 foreign) S/N 017-000-00550-9, by writing to the Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Telephone orders can be placed to 202-512-2250. The document is also available in CD-ROM format, S/N 017-001-00549-5 for $19 ($23.50 foreign) as well as on the Internet at http://www.healthypeople.gov/. (FDA has verified the Web site address, but we are not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Internet viewers should proceed to "Publications."
Support will be in the form of a cooperative agreement. This agreement will be subject to all policies and requirements that govern the research grant programs of the PHS, including provisions of 42 CFR Part 52, 45 CFR Parts 74 and 92, and PHS’s grants policy statement. The regulations issued under Executive Order 12372, Intergovernmental Review of Federal Programs (45 CFR Part 100) do not apply. The National Institutes of Health (NIH) modular grant program does not apply to this FDA program.
Support of this program, if awarded, will be in the form of a cooperative agreement. In FY 2006 FDA anticipates providing up to $2.3 million (direct and indirect costs combined) for this award. It is anticipated that funding may increase up to $2.6 million in the subsequent noncompetitive years based on possible increases in appropriations.
The length of support will be 1 year, with the possibility of an additional 4 years of noncompetitive support. Continuation, beyond the first year, will be based upon satisfactory performance during the preceding year and the availability of Federal fiscal year appropriations.
This award will be funded based on the quality of the application received and is subject to availability of Federal funds to support the project.
In addition, if a cooperative agreement is awarded, the grantee will be informed of any additional documentation that should be submitted to FDA. This cooperative agreement program does not require the applicant to match or share in the project costs if an award is made.
Substantive involvement by the awarding agency is inherent in the cooperative agreement award. Accordingly, FDA will have substantial involvement in the program activities of the projects funded by the cooperative agreement. Substantive involvement includes, but is not limited to, the following:
FDA believes that there is compelling evidence that the University of Mississippi (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 CFSAN’s areas of interest. The UM School of Pharmacy has been in existence for 90 years and has an outstanding 30-year track record for isolating and developing prospective new pharmaceuticals from plants and microorganisms.
The National Center for Natural Products Research (NCNPR), which opened in July 1995, is a division of the Research Institute of Pharmaceutical Sciences of the University of Mississippi School of Pharmacy. NCNPR was created to bring together an alliance of academia, government, and the pharmaceutical and agrochemical industries to integrate research, development, and commercialization of potentially useful natural products. The facility is the nation’s only university-affiliated research center devoted to improving human health and agricultural productivity through the discovery, development, and commercialization of pharmaceuticals and agrochemicals derived from natural products.
The goal of the 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 pharmaceuticals, dietary supplements and agrochemicals. 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 employees 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.
Cost sharing is not required.
The application request and the completed application should be submitted to Gladys M. Bohler, Grants Management Specialist, Division of Contracts and Grants Management (HFA-500), Food and Drug Administration, 5630 Fishers Lane, Rm. 2105, Rockville, MD 20857, 301-827-7168, e-mail:
If the application is hand-carried or commercially delivered it should be addressed to 5630 Fishers Lane, rm. 2105, Rockville, MD 20857. Do not send the application to the Center for Scientific Research (CSR), National Institutes of Health (NIH).
Since application submission through www.grants.gov will become mandatory in fiscal year 2007, the applicant is encouraged to use the grants.gov Web site to submit the application. Information on electronic submission can be found in 2.A. below. If submitted as a paper copy, application requests and completed applications should be submitted to Gladys M. Bohler, Grants Management Specialist, Division of Contracts and Grants Management (HFA-500), Food and Drug Administration, 5630 Fishers Lane, Rm. 2105, Rockville, MD 20857, 301-827-7168, e-mail: Applications that are hand-carried or commercially delivered should be addressed to 5630 Fishers Lane, Rm. 2105, Rockville, MD 20857.
Do not send applications to the Center for Scientific Research (CSR), NIH.
FDA will accept the application for this program electronically via www.grants.gov. The applicant is encouraged to apply electronically by visiting the web site www.grants.gov and following instructions under "Apply for Grants." The required application, SF 424RR (Research & Related Portable Document Formats) can be completed and submitted online. The package should be labeled "Response to RFA-FDA-CFSAN-2006-2". If you experience technical difficulties with your online submission you should contact either the grants.gov Customer Response Center or Gladys M. Bohler (see section IV. 1.) for assistance. To comply with the President’s Management Agenda, HHS is participating as a partner in the new government-wide grants.gov apply site. Users of www.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 participation in the grants.gov project. Information about submitting an application electronically can be found on the www.grants.gov Web site. In order to apply electronically, the applicant must have a DUNS number and register in the CCR database as described in sections IV.5 of this document. If submitted other than electronically, please call Gladys M. Bohler for guidance (see Addresses to Request application in section IV.1 of this document) prior to submission.
If submitted electronically, the application must be on SF424 Research and Related Portable Document Format. If submitted in paper copy, the application must be submitted on Grant Application Form SF 424. All "General Instructions" and "Specific Instructions" in the application kit must be followed. The face page of the application, either electronic or paper, should reflect the request for applications number RFA-FDA-CFSAN-2006-2.
The applicant has the option of omitting from the application copies (but not from the original) specific salary rates or amounts for individuals specified in the application budget and Social Security numbers if otherwise required for individuals. The copies may include summary salary information.
Data and information included in the application will generally not be publicly available prior to the funding of the application. After funding has been awarded, data and information included in the application will be given confidential treatment to the extent permitted by the Freedom of Information Act (5 U.S.C. 552(b)(4)) and FDA's implementing regulations (including 21 CFR 20.61, 20.105, and 20.106). By accepting funding, the applicant agrees to allow FDA to publish specific information about the cooperative agreement.
Information collection requirements requested on Form SF424 Research and Related Portable Document Formats were approved and assigned OMB control number 4040-0001.
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 Addresses to Request Application in sections IV 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 CSR at 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. Applications must be submitted via U.S. mail or commercial carrier or hand delivered as stated previously. 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.
There are no funding restrictions.
Consent forms, assent forms, and any other information given to a subject are part of the grant application and must be provided, even if in a draft form. The applicant is referred to DHHS regulations at 45 CFR 46.116 and 21 CFR 50.25 for details.
As of October 1, 2003, applicants are 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, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, call 1-866-705-5711. Be certain that you identify yourself as a Federal grant applicant when you contact Dun and Bradstreet.
In anticipation of the grants.gov electronic application process, applicants are encouraged to register with the Central Contractor Registration (CCR) database. This database is a government-wide warehouse of commercial and financial information for all organizations conducting business with the Federal Government. Registration with CCR will eventually become a requirement and is consistent with the government-wide Management Reform to create a citizen-centered web presence and build e-gov infrastructures in and across agencies to establish a "single face to industry." The preferred method for completing a registration is through the World Wide Web at http://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. You must have a DUNS number to begin your registration. For foreign entities the Web site is http://www.grants.gov/RequestaDUNS.
In order to access grants.gov an applicant will be required to register with the Credential Provider. Information about this is available at http://www.grants.gov/applicants/register_credential_provider.jsp.
FDA grants management and program staff will review the application sent in response to this notice. To be responsive, the application must be submitted in accordance with the requirements of this notice and must bear the original signatures of both the principal investigator and the applicant institution's/organization's authorized official. If the application is found to be non-responsive it will be returned to the applicant without further consideration. The applicant is strongly encouraged to contact FDA to resolve any questions about criteria before submitting the application. Please direct all questions of a technical or scientific nature to the CFSAN program staff and all questions of an administrative or financial nature to the grants management staff (see Agency Contacts in section VII of this document).
First, the grants management and program staff will review the application submitted in response to this request for application (RFA) for responsiveness. To be responsive, the application must: (1) be received by the specified due date, (2) be submitted in accordance with section IV. "Application and Submission" of this document, (3) not exceed the recommended funding amount stated within section I. "Funding Opportunity Description" of this document, (4) address the specific program goals and objectives as detailed in section I.2.B. "Project Emphasis", and (5) bear the original signatures of both the principal investigator and the University’s authorized official. Staff will consider the application non-responsive if it does not contain the information set forth in this section. If the application is found to be non-responsive, the staff will return the application to the applicant without further consideration. The staff will also consider an application non-responsive for any of the following reasons: (1) The applicant organization is ineligible, (2) it is received after the specified receipt date, (3) it is incomplete, (4) it is illegible, (5) it is not responsive to the RFA, or (6) the material presented is insufficient to permit an adequate review.
Next, if the application is responsive, it will undergo a dual peer review. A responsive application will be reviewed first for scientific and technical merit by an ad hoc panel of experts in areas associated with, but not limited to, natural products, botanical dietary supplements, human health and nutrition. The application will then be presented to the National Advisory Environmental Health Sciences Council for their concurrence with the ad hoc panel’s recommendation.
The ad hoc expert panel will review the application based on the following scientific and technical merit criteria:
A responsive application will be reviewed and evaluated for scientific and technical merit by an ad hoc panel of experts in the subject field of the specific application. A responsive application will be subject to a second review by a National Advisory Council for concurrence with the recommendations made by the first-level reviewers, and funding decisions will be made by the Commissioner of Food and Drugs or his designee.
A score will be assigned based on the scientific/technical review criteria. The review panel may advise the program staff about the appropriateness of the proposal to the goals of the CFSAN cooperative agreement program.
Notification regarding the results of the review is anticipated by September 15, 2006. The expected start date for this award will be September 30, 2006.
Applicants must adhere to the requirements of this Notice. Special Terms and Conditions regarding FDA regulatory requirements and adequate progress of the study may be part of the awards notice.
See Section II, of this document, under "Award Information" for national policy requirements regarding "Smoke-free Workplace", and "Healthy People 2010"; and in Section II, #1, "Award Instrument", for information on the policies and requirements that govern research grant programs of the PHS, including provisions of 42 CFR Part 52, 45 CFR Parts 74 and 92, and PHS Policy Statement.
Consent forms, assent forms, and any other information given to a subject are part of the grant application and must be provided, even if in a draft form. The applicant is referred to DHHS regulations at 45 CFR 46.116 and 21 CFR 50.25 for details.
The original and two copies of the annual Financial Status Report (FSR) (SF-269) must be sent to FDA's grants management officer within 90 days of the budget period end date of the grant. For continuing cooperative agreements, an annual program progress report is also required. For such cooperative agreements, the noncompeting continuation application (PHS 2590) will be considered the annual program progress report.
A final program progress report and financial status report will be due 90 days after expiration of the project period of the cooperative agreement as noted on the notice of grant award.
The program project officer will monitor the grantee periodically. The monitoring may be in the form of telephone conversations, e-mails or written correspondence between the project officer/grants management officer and the principal investigator. Periodic site visits with officials of the grantee organization may also occur. The results of these monitoring activities will be recorded in the official grant file and will be available to the grantee upon request consistent with applicable disclosure statutes and with FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the cooperative agreement, including those which state that future funding of the study will depend on recommendations from the project officer. The grantee must file a final program progress report, FSR and invention statement within 90 days after the end date of the project period as noted on the notice of grant award.
For issues regarding the programmatic aspects of this notice: Jeanne I. Rader, Center for Food Safety and Applied Nutrition (HFS-840), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1786 e-mail: .
For issues regarding the administrative and financial management aspects of this notice: Gladys M. Bohler (see Addresses to Request Application in Section IV of this document).
Data included in the application, if restricted with the legend specified below, may be entitled to confidential treatment as trade secret or confidential commercial information within the meaning of the Freedom of Information Act (5 U.S.C. 552(b)(4)) and FDA’s implementing regulations (21 CFR 20.61).
Unless disclosure is required under the Freedom of Information Act as amended (5 U.S.C. 552) as determined by the freedom of information officials of the Department of Health and Human Services or by a court, data contained in the portions of this application that have been specifically identified by page number, paragraph, etc. by the applicant as containing restricted information, shall not be used or disclosed except for evaluation purposes.
See also FedGrants Federal Funding Opportunity No. RFA-FDA-CFSAN-2006-2 National Center for Natural Products Research August 29, 2006
National Center for Natural Products Research, University of Mississippi; Single Source Cooperative Agreement; Catalog of Federal Domestic Assistance Number 93.103; Request for Application Federal Register Notice, August 25, 2006
