Part I Overview Information
Department of Health and Human Services
U.S. Food and Drug Administration (FDA)
The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Peer Review Process.
Components of Participating Organizations
Center for Food Safety and Applied Nutrition (CFSAN)
Funding Opportunity Title
Food and Drug Administration (FDA) and Marine Environmental Sciences Consortium/Dauphin Island Sea Lab (DISL) Collaboration (U19)
U19 Research Program – Cooperative Agreements
Announcement Type:Reissue of Federal Register notice RFA-FD-09-017
Related Notices: None
Funding Opportunity Announcement (FOA) Number:RFA-FD-11-015
Companion FOA: None
Number of Applications
Only one application is allowed, as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)
FDA is announcing the availability of 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 scientific, public health, and policy expertise within the Food and Drug Administration (FDA) will provide opportunities for collaborations that support the Dauphin Island Sea Lab (DISL) mission. The DISL's nationally ranked programs, leading-edge research collaborations, and innovative business partnerships provide an environment to support diverse multidisciplinary exchanges with FDA. These joint efforts will provide the basis for development of scientific collaborations, outreach, educational initiatives and intellectual partnerships between FDA and DISL.
Letters of Intent Due Date: Not Applicable
Application Due Dates(s): August 1, 2011
AIDS Application Due Date(s): Not Applicable
Scientific Merit Review: August 2011
Advisory Council Review: Not Applicable
Earliest Start Date(s): September 2011
Expiration Date: August 2, 2011
Due Dates for E.O. 12372: Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the PHS398 Application Guideexcept where instructed to do otherwise (in this FOA). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Table of Contents
This Funding Opportunity Announcement (FOA) issued by the Center for Food Safety and Applied Nutrition (CFSAN)/Office of Food Safety, Division of Seafood Science and Technology (DSST) is soliciting a sole source grant application from the Marine Environmental Science Consortium - Dauphin Island Sea Lab (DISL). FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (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 working to ensure the safety and security of foods. 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 DISL will greatly contribute to FDA's mission.
The cooperative agreement will establish terms of collaboration between FDA's DSST 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:
- Scientific intellectual exchange between university faculty and staff and FDA scientists and staff;
- Educational opportunities for qualified students (graduate and post-graduate), staff members and faculty members in DSST and DISL's laboratories, classroom, and offices;
- Joint meetings for research and education;
- Research collaboration in projects of mutual interest;
- Cooperative international activities including outreach;
- Sharing of unique facilities and equipment for increased cost efficiencies for scientific endeavors;
- Promulgation and communication of identified collaborative efforts through appropriate means;
- Adjunct, affiliate, and research faculty appointments for appropriate FDA professional staff, provided that appointments of such candidates will advance specific programmatic objectives and comply with university faculty/affiliates appointment policies;
- Collaborate in the development of regular workshops where faculty from all the institutions within DISL and FDA scientists and staff share information about on-going research, education and outreach efforts of mutual interest; and
- Develop joint efforts to obtain grants and other extramural funds to support collaborative research and training as permitted under appropriate statutory authority.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed
The OER Glossaryand the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards
CFSAN intends to fund one award reflecting a total funding of $625,000, depending on the availability of funds and recipient performance.
The estimated amount in FY12 will be up to $125,000.00 with the possibility of four additional years of support in the amount of $125,000.00 per year contingent upon the availability of funds and performance.
Award Project Period
Up to five years, from FY2012-FY2016, contingent upon the availability of funds and performance.
FDA grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
1. Eligible Applicants
Marine Environmental Science Consortium - Dauphin Island Sea Lab
Competition is limited to DISL because there are no other organizations that can provide the required proximity to DSST and independent marine fieldwork capability required. DISL possesses extensive laboratory and wet-laboratory resources relevant to the mission of DSST, and is located within one mile of DSST, which will allow for easy collaboration.
DSST and DISL have a shared interest in scientific progress in the diverse disciplines that directly and indirectly affect seafood safety and human and animal health. DSST and DISL 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. This unique circumstance of capability, capacity, and proximity is irreplaceable without extended and costly concessions.
Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
- Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
- eRA Commons
All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.
Eligible Individuals (Program Director/Principal Investigator)
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for FDA support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.
2. Cost Sharing
This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.
3. Additional Information on Eligibility
Number of Applications
Only one application is allowed.
FDA will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. FDA will not accept any application that is essentially the same as one already reviewed.
1. Address to Request Application Package
Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.
It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, package to:
Gladys M. Bohler
Food and Drug Administration
OAGS/Rm. 1078/HFA 500
5630 Fisher's Lane
Rockville, MD 20857
E-mail: gladys.bohler @fda.hhs.gov
At the time of submission, three additional paper copies of the application and all copies of the appendix files must be sent to:
Dr. Robert Dickey
Center for Food Safety and Applied Nutrition (CFSAN)
One Iberville Drive, PO
D1-1Rm 122, HFS 400
Dauphin Island, AL 36528
All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:
- Research Strategy section is limited to 30 pages.
All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:
- Resource Sharing Plan
All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide, with the following modifications:
3. Submission Dates and Times
Part I. Overview Information contains information about Key Dates.
Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.
Applicants may track the status of the application via e-mail.
4. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Pre-award costs are allowable only as described in the HHS Grants Policy Statement.
6. Other Submission Requirements and Information
Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed. .
Upon receipt, applications will be evaluated for completeness by the Grants Management Contact and responsiveness by the CFSAN Program staff at FDA. Applications that are incomplete will not be reviewed.
Post Submission Materials
Acceptable post-submission materials include:
Revised budget page(s) (e.g., change in budget request due to new funding or institutional acquisition of equipment)
Biographical sketches (e.g., change in senior/key personnel due to the hiring, replacement, or loss of an investigator)
Letters of support or collaboration resulting from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator
Adjustments resulting from natural disasters (e.g., loss of an animal colony)
Adjustments resulting from change of institution (e.g., PI moves to another university)
News of an article accepted for publication (a copy of the article should not be sent)
All post-submission materials must conform to NIH policy on font size, margins, and paper size as referenced in Part I.2.6 of the applicable application instructions. NIH additional form pages such as budget, biographical sketches, and other required forms must follow NIH standards for required NIH form pages.
If post-submission material is not required on a form page, each explanation or letter is limited to one page (see Acceptable Late Materials above).
If the application has subprojects or cores, each subproject or core is allowed explanations or letters (see Acceptable Late Materials above), but each explanation or letter is limited to one page.
Unacceptable post-submission materials (for all applications except those listed under Exceptions below) include:
Updated Specific Aims or Research Strategy pages
Late-breaking research findings
New letters of support or collaboration that do not result from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator.
Only the review criteria described below will be considered in the review process. As part of the FDA Mission, all applications submitted to the FDA in support of research are evaluated for scientific and technical merit through the FDA Ad Hoc review process.
Overall Impact - Overall
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Scored Review Criteria - Overall
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice are improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Additional Review Criteria - Overall
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Protections for Human Subjects
Inclusion of Women, Minorities, and Children
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions: Not Applicable.
Renewals: Not Applicable.
Revisions: Not Applicable.
Additional Review Considerations - Overall
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with FDA Ad Hoc Review procedures, using the stated review criteria.
As part of the scientific peer reviews, all applications:
- Will receive a written critique.
The following will be considered in making funding decisions:
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds. e.
- Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates
After Ad Hoc review of the application is completed, the PD/PI will receive his or her Summary Statement (written critique) via e-mail.
Information regarding the disposition of applications is available in the HHS Grants Policy Statement.
1. Award Notices
If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.
Awardees must comply with any funding restrictions described Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements.
2. Administrative and National Policy Requirements
All HHS grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and FDA grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the FDA purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the FDA as defined below.
The Principal Investigator will have the primary responsibility for and dominant role in planning, directing, and executing the proposed project, with the FDA staff being substantially involved as a partner with the PI.
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and FDA policies.
An FDA Project Officer will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The program project officer will monitor the grantee periodically. The monitoring may be in the form of telephone conversations, emails, 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 that state that future funding will depend on recommendations from the project officer. In addition,
FDA will have prior approval of the appointment of all key administrative and scientific personnel proposed by the grantee.
FDA will be directly involved in the guidance and development of the program.
FDA scientists will participate, with the grantee, in determining and carrying out scientific and technical activities. Collaboration will also include data analysis, interpretation of findings and, where appropriate, co-authorship of publications.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov oon all subawards over $25,000. See the HHS Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Dr. Robert Dickey
Center for Food Safety and Applied Nutrition (CFSAN)
One Iberville Drive, PO
D1-1Rm 122, HFS 400
Dauphin Island, AL 36528
Financial/Grants Management Contact(s)
Food and Drug Administration
Office of Acquisition and Grant Services (OAGS)
Rm. 1078; HFA 500
Rockville, MD 20857
All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Authority and Regulations
Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.