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July 6, 2007
(Federal Register Notice July 6, 2007)
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 2007 (FY07) to the University of Maryland, College Park (UMCP) to support the Joint Institute for Food Safety and Applied Nutrition (JIFSAN), which is located on the University of Maryland Campus in College Park, MD. An estimated amount of support in FY07 will be for up to $2.0 million (direct plus indirect costs) the total amount being subject to annual budget appropriations, with an additional four years of support. This award will strengthen existing programs and allow expansion of JIFSAN's education, outreach and applied research programs and external partnerships that have already been established. Competition is limited to UMCP because of the unique partnership between FDA and UMCP. The cooperative agreement will continue to allow for a more efficient use of research, scientific, education, and outreach resources, which enhance overall public health by expanding and improving food safety and nutrition as well as other program areas that affect public health policy.
Through a formal Memorandum of Understanding (MOU) between the FDA and UMCP, the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) was established as a jointly administered, multidisciplinary research, education and outreach partnership in April 1996. The close proximity of UMCP and FDA's Centers for Food Safety and Applied Nutrition (CFSAN) and Veterinary Medicine (CVM) provides opportunities for extensive collaboration and for mutually leveraging resources for the greater benefit of the nation's food safety system.
In the Federal Register of May 22, 1997 (65 FR 28049), FDA published a request for a single source application for a cooperative agreement to support JIFSAN. The application was reviewed and approved by an ad hoc panel of experts. The panel's recommendation was then approved by the National Advisory Environmental Health Sciences Council in September 1997.
In the Federal Register of July 26, 1999 (64 FR 40380), FDA published a notice of its intention to non-competitively supplement the cooperative agreement with UMCP on September 29, 1999.
In the Federal Register of July 5, 2002 (67 FR 44854), FDA published a notice of its intent to renew the cooperative agreement with UMCP. The application was reviewed and approved by an ad hoc panel of experts. The panel's recommendation was then approved by the National Advisory Environmental Health Sciences Council in September 2002. FDA awarded the renewal of the cooperative agreement to UMCP on September 30, 2002.
Under the cooperative agreement UMCP has provided an administrative staff for JIFSAN and supported shared resources (e.g., nuclear magnetic resonance (NMR) and electron microscopy facilities). UMCP and FDA through JIFSAN have developed numerous collaborations among UMCP faculty and FDA scientists and professional staff; developed a unique undergraduate research program; established the Risk Analysis Clearinghouse; received designation as a Food and Agricultural Organization/World Health Organization(FAO/WHO)Collaborating Center for Food Safety Risk Analysis; developed a Risk Analysis Professional Development program; developed an extensive network of contacts including faculty from other universities to expand JIFSAN's available science expertise; and developed international food safety education and outreach programs (e.g., Good Agricultural Practices, Good Aquacultural Practices) that foster implementation of effective food safety practices. The unique administrative structure of UMCP-JIFSAN allows it to effectively use resources to plan, organize and run multidisciplinary, multi-institutional programs in research, education, and outreach. The structure and policies of a major land grant university offer the flexibility needed to enable UMCP-JIFSAN to create and operate strategic alliances involving multiple partners and multiple funding sources. Moreover, UMCP-JIFSAN provides a neutral environment in which experts from industry, consumer and trade groups, international organizations, government agencies, and academia can pool their resources and ideas to support and benefit the public health by promoting more efficient development and dissemination of science-based information.
FDA believes that UMCP-JIFSAN is a sound investment that enhances the health of American consumers. FDA faces an increasing number of critical and complex food safety and public health issues associated with the products that FDA regulates (i.e., foods; cosmetics; and animal drugs and feed additives). These complex issues can be addressed most efficiently by expanding the available science base through the development of collaborative partnerships. FDA believes that partnering with UMCP-JIFSAN will continue to stimulate the integration of applied research, education and outreach programs and will continue to enhance FDA's ability to address safety and other public health issues related to foods, cosmetics and animal health. Further, FDA believes that collaboration with UMCP-JIFSAN promotes efficient use of complementary resources (e.g., NMR and electron microscopy facilities) and provides opportunities to leverage additional resources. This partnership stimulates collaborative scientific activities (including applied research, education and outreach) among government, academia, industry and consumers to address new and emerging issues associated with an increasingly global food supply. Relationships established through this partnership enhance FDA's efforts to partner with other nations to improve worldwide health. FDA's participation in this venture will continue to promote a greater awareness and understanding of regulatory science and practice among academic scientists and the pool of future scientists. However, only FDA can perform official regulatory activities related to these issues.
The UMCP-JIFSAN partnership provides a dynamic program that integrates applied research, education and outreach that enhance FDA's ability to address safety concerns and public health issues related to foods, cosmetics and animal health. Applied research includes not only traditional laboratory and field research but also includes educational research and behavioral or social research, such as research focused on defining the behavioral determinants that promote sound food safety practices.
A proposal is being solicited for the design, implementation and evaluation of a comprehensive, multidisciplinary array of scientific activities to address public health issues related to FDA's food safety, applied nutrition, food defense, animal health science, cosmetics, food labeling, and risk analysis programs. The proposal must be designed to meet the objectives (see below) of the request for application (RFA). It should include innovative approaches for building robust and sustainable international and domestic research and outreach collaborations, as well as strategies for cultivating additional base support for the partnership.
Integrated cooperative research, education and outreach programs developed through UMCP-JIFSAN will continue to provide opportunities to address scientific issues related to national and international food safety and public health problems. The programs developed through this cooperative agreement will provide mechanisms to strengthen existing and develop additional partnerships with academia, industry, non-governmental organizations, and international organizations. These partnerships will promote and sustain collaborative domestic and international outreach and education programs and applied research programs that focus on FDA-regulated products (i.e., foods; cosmetics; and animal drugs and feed additives). The objectives of this cooperative agreement between the FDA and UMCP are:
Support will be in the form of a cooperative agreement. Accordingly, FDA will have substantial involvement in the program activities of the project. FDA will support the collaboration covered by this notice under the authority of Section 301 of the Public Health Service (PHS) Act (42 U.S.C. 241).
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. For more information visit "Healthy People 2010" at: http://www.healthypeople.gov/ (Internet viewers should proceed to "Publications".) (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.)
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 and 45 CFR Parts 74 and 92, and all grants are subject to the terms and conditions, cost principles, and other considerations described in the October 1, 2006, HHS Grants Policy Statement (GPS), which supersedes in its entirety the above sited PHS GPS, dated April 1, 1994, and addendum dated January 24, 1995.
This award is subject to the requirements of the HHS Grants Policy Statement (HHS GPS) that are applicable to you based on your recipient type and the purpose of this award. This includes any requirements in Parts I and II (available at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm) of the HHS GPS that apply to an award.
Although consistent with the HHS GPS, any applicable statutory or regulatory requirements, including 45 CFR part 74 or 92, directly apply to this award apart from any coverage in the HHS GPS.
The regulations issued under Executive Order 12372, Intergovernmental Review of Federal Programs (45 CFR Part 100) do not apply.
In FY 2007 FDA anticipates providing up to $2.0 million (direct and indirect costs) for this award based on the availability of Federal fiscal year appropriations.
The award will provide one year of support and include future recommended support for 4 additional years, which will be 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.
This award will be funded based on the quality (e.g. how well the grantee responds to the RFA requirements) 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 requires that the applicant substantially 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 UMCP is uniquely qualified to fulfill the objectives of the proposed cooperative agreement. UMCP is in close proximity to the FDA's Center for Food Safety and Applied Nutrition's (CFSAN's) and the Center for Veterinary Medicine's (CVM's) offices and laboratories in Prince George's County, MD. UMCP has vast resources that complement and greatly expand FDA's research, scientific, education, and outreach resources. As the UMCP and FDA are both located within the greater Washington, DC, area increased interactions with the USDA Beltsville Agricultural Research Center and other world class research and medical institutions are possible. UMCP is the Washington region's most comprehensive research institution, with numerous academic programs relevant to FDA's mission and the resources to support CFSAN's areas of interest, including: microbiology, chemistry, food science, animal health sciences, agriculture, public policy, risk assessment, computational science, economics, and survey methodology. UMCP serves as a primary center for graduate study and research and provides undergraduate and graduate instruction across a broad spectrum of academic disciplines. The University extends its intellectual resources to the community through innovative projects designed to serve individuals, governments, and the private sector throughout the State of Maryland, the nation, and the international community.
The University has developed core facilities to provide effective use of state-of-the-art scientific instrumentation with high acquisition, installation, and maintenance costs to conduct research at the forefront of science. An electron microscopy facility jointly supported by FDA and the University opened in 2000. CFSAN has moved its nuclear magnetic resonance (NMR) instrumentation and personnel to the University's NMR facility in the Chemistry building. These instrumentation centers complement CFSAN's resources and expertise.
The University has developed FoodRisk.org (formerly the Risk Analysis Clearinghouse) which is the only web-based information resource specializing in food safety risk analysis, including risk assessment, risk management, and risk communication. Users include government officials from around the world seeking the latest risk assessment, or training and workshop opportunities. FoodRisk.org contains: 1) data and tools for researchers seeking to fill data gaps, build models, and develop expertise; 2) specialized data, peer networks, and access to modeling tools for risk assessors and project managers; and 3) the latest risk assessments, and information on workshops and training opportunities for interested individuals from around the world. FoodRisk.org also operates the FAO/WHO Acrylamide in Food Network, the internationally sanctioned repository for information about the safety and prevention of acrylamide in food.
The University through JIFSAN has developed a broad range of international agreements with: 1) the Ministry of Science and Technology Thailand; 2) the Korea Food and Drug Administration (KFDA); 3) the Central Science Laboratory, Department for Environment Food and Rural Affairs in York, UK; and 4) the Department of Natural Resources and Environment in Victoria Australia. Additionally JIFSAN has been designated a Pan American Health Organization (PAHO)/WHO Collaborating Center for Food Safety Risk Analysis. These agreements enable UMCP and JIFSAN to: 1) further promote international scientific, education, outreach and cooperative research activities; and 2) deepen the understanding of the scientific, economic and social issues/needs within the respective countries.
Acknowledging the importance of an interdisciplinary approach to knowledge, the University maintains organized research units outside the usual academic department structures. Through collaborative projects, FDA has access to additional University resources that include: 1) The Center for Risk Communication Research where cooperative projects related to risk communication studies have been and will continue to be developed; 2) The Center for Food Systems Security and Safety, within the College of Agriculture and Natural Resources, providing opportunities for the development of multidisciplinary food safety research using an integrated food systems approach; and 3) The Maryland NanoCenter, established as a partnership among the A. James Clark School of Engineering, the College of Computer, Math, and Physical Sciences (CMPS), and the College of Chemical and Life Sciences, provides access to major nano-research, equipment and informational seminars that could foster trans-disciplinary collaboration among a critical mass of researchers spanning the sciences and engineering.
As UMCP is part of the University System of Maryland (comprised of eleven universities, two research institutions and two regional higher education centers) additional education, research and outreach expertise through affiliated campuses/faculty may be accessed to build additional relationships that advance our mutual goals.
Collaboration between the public and the private sectors has proven to be an efficient means for both FDA and the University to remain current with scientific and technical advances associated with FDA regulated products (i.e., foods, cosmetics and animal drugs and feed additives). The degree to which we nurture, develop and build on these collaborations directly affects our ability to enhance public health. The information and expertise obtained through this partnership between FDA and UMCP can be leveraged by all segments of the food safety and nutrition community, as well as by public health organizations, other Federal agencies, and academic institutions in the performance of their roles.
This cooperative agreement program requires that the applicant substantially share in the project costs if an award is made including, but not limited to, partial salary support for administrative staff and in-kind support (e.g. faculty salaries, facilities costs, etc.).
Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this funding opportunity through the Grants.gov/Apply http://www.grants.gov/Apply Web site. Note: Only the forms package directly attached to this specific funding opportunity in Grants.gov can be used.
Prepare the application using the SF 424 (R& R application forms). The SF 424 (R&R) application is comprised of data arranged in separate components. Some components of the SF 424 (R&R) are required, others are optional. All applicable components, required and optional will be part of the forms package associated with this funding opportunity in found under FDA funding opportunities in Grants.gov/Apply.
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 424 (Research & Related) (also referred to as the "SF424 (R&R)"), can be completed and submitted online. The package should be labeled "Response to RFA-FD-07-001 CFSAN. If you experience technical difficulties with your online submission you should contact Gladys M. Bohler by telephone 301-827-7168 or by e-mail . 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.
Paper applications will not be accepted. The application must be in the format specified on www.grants.gov. All required documents in the online application package must be completed and submitted via Grants.gov.
The applicant has the option of omitting from the application specific salary rates or amounts for individuals specified in the application budget. However, this information will be requested and required prior to award.
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)) 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. The collection of information on Form SF424 (R&R) has been approved and assigned OMB control number 4040-0001.
The application receipt date is within 30 days after publication of the Funding Opportunity Announcement in the Federal Register. The application will be accepted from 8 a.m. to 4:30 p.m., Monday through Friday until the established receipt date. 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.
All grants are subject to the terms and conditions, cost Principles, and other considerations described in the October 1, 2006, the HHS Grants Policy Statement (GPS), which supersedes in its entirety the above sited PHS GPS, dated April 1, 1994, and addendum dated January 24, 1995.
This award is subject to the requirements of the HHS Grants Policy Statement (HHS GPS) that are applicable to you based on your recipient type and the purpose of this award. This includes any requirements in Parts I and II (available at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm) of the HHS GPS that apply to an award.
Although consistent with the HHS GPS, any applicable statutory or regulatory requirements, including 45 CFR part 74 or 92, directly apply to this award apart from any coverage in the HHS GPS.
In addition, the Terms and Conditions of award will be determined prior to award of the cooperative agreement.
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.
Applicants must 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. 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.gov. In order to access grants.gov an applicant will be required to register with the Credential Provider. Information about this is available at https://apply.grants.gov/OrcRegister.
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. 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, an 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.
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 food safety, human health, and nutrition and risk analysis. The application will then be presented to the National Institute's of Health, National Cancer Advisory Board for their concurrence with the ad hoc panel's recommendation.
The ad hoc panel of experts will evaluate applications based on the extent to which they demonstrate or advance the following scientific and technical 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 level review by the National Cancer Advisory Board for concurrence with the recommendations made by the first-level reviewers, and funding decisions will be made by the Commissioner of the Food and Drug Administration 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 within two weeks after review of the application. The expected start date for this award will be no later than September 30, 2007.
The FDA Grants Management Office will notify the applicant if they have been selected for an award. The award will be issued on a Notice of Grant Award, signed by the FDA Grants Management Officer and be sent to the applicant by mail or be transmitted electronically.
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.
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 Specialist within 90 days of each budget period end date.
Annual program progress reports must be submitted with all non-competing continuation applications electronically via Grants.gov.
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 grant, 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: Christine Hileman, Center for Food Safety and Applied Nutrition (HFS-006), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1674 e-mail:
For issues regarding the administrative and financial management aspects of this notice contact, Gladys Melendez-Bohler at 301-827-7168 or by e-mail at .
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.
Dated: __________________________
Associate
Commissioner for Policy
See also FedGrants Federal Funding Opportunity No. FD07-001 Cooperative Agreement to Support the Joint Institute for Food Safety and Applied Nutrition July 10, 2007
