Participating Organization(s)	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 Devices and Radiological Health (CDRH)
Funding Opportunity Title	Developing Innovative Methodologies and Device-Specific Infrastructure through the Medical Device Epidemiology Network: Applications for Medical Countermeasure-Associated Devices (U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	New
Related Notices	December 18, 2012 - See Notice NOT-FD-13-001. Request for Information (RFI): MDEpiNET PPP.
Funding Opportunity Announcement (FOA) Number	RFA-FD-12-010
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.103
FOA Purpose	1. Advance and apply innovative methodological solutions to bridge premarket and postmarket evidence of medical countermeasures (MCM)-related device safety and effectiveness, including evidence synthesis, and evaluation of medical device patient-centered outcomes across the total product life cycle (TPLC). 2. Conduct highest quality independent research to contribute to medical device regulatory decision-making for MCM-priority medical devices and radiological health. 3. Advance development, implementation, and evaluation of postmarketing surveillance systems and their application to MCM-priority medical device regulatory science. 4. Promote communication with stakeholders and educational outreach of innovative MCM medical device surveillance and scientific strategies.

Posted Date	March 15, 2012
Open Date (Earliest Submission Date)	April 1, 2012
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	April 30, 2012, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	May or June, 2012
Advisory Council Review	August, 2012
Earliest Start Date(s)	September, 2012
Expiration Date	May 1, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except 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. 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.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

FDA uses many tools to assess medical device performance in the postmarket arena, including mandated postmarket studies, registries and other databases; however, historically there has been no systematic integration of all available data for regulatory decision making. The Medical Device Epidemiology Network (MDEpiNet) is a public private partnership between FDA/CDRH and leading academic centers whose aim is to bridge evidentiary gaps and develop infrastructure and innovative methodological approaches for conducting analytic studies to improve FDA understanding of safety and effectiveness of medical devices throughout their life cycle, by integrating resources and expertise from multiple stakeholders. This collaborative effort allows FDA/CDRH to leverage resources and expertise from multiple experts and decision makers, and will allow all stakeholders to significantly improve the credibility, relevance, and efficiency of clinical research regarding medical devices.

The MDEpiNet partnership can be utilized to gain scientific and clinical grounding for the medical countermeasures (MCM) initiative, in order to develop the groundwork for the best evidence-based decision-making which is needed prior to a chemical, biological, radiological, or nuclear (CBRN) event to evaluate the safety and effectiveness of medical devices and radiological products before, during, and after an event and to ensure that MCM is part of the total product life cycle for these devices and products. By leveraging the MDEpiNet partnership, it is expected that the regulatory science advances in infrastructure and methodology developed through the efforts of this MCM project will be applicable to a broad range of medical device areas and that this work will strengthen overall lifecycle performance evaluation capabilities. Thus, this project will both:

(a) facilitate systematic evaluation and integration of available data for medical devices and radiological health with a focus on devices potentially affected by a CBRN agent event and

(b) advance regulatory science to improve the knowledge base for methodological design and infrastructure capabilities throughout the total product life cycle.

To be prepared to evaluate medical devices and radiological health in the event of a variety of potential CBRN agent events, three aspects of medical device (and radiological product)-associated MCM measurement may be needed. First, there are devices (and radiological products) that are likely to be used more frequently during a CBRN emergency event. These devices (including ventilators, influenza-related devices, and hemostatic and lifesaving devices) will need careful monitoring for safety and effectiveness before, during, and after the event. Second, there are devices that are likely to be used in more vulnerable populations or that have already been in use in populations that will become more vulnerable. These devices (including radiological products, hip implants, wound therapies, and devices used for infection control) will need an established baseline assessment in postmarket datasets in order to quickly identify differences in effectiveness and safety in patient populations made vulnerable by CBRN events. Third, there are devices whose safety or effectiveness may be compromised in the event of a CBRN event or that are the target of an attack. These devices include primarily electric devices or radiological products (examples include cardiac resynchronization therapy and magnetic resonance imaging). A baseline assessment in postmarket datasets will need to be established prior to a CBRN event in order to quickly identify differences in effectiveness and safety due to such an event.

This project will compile and continually update all of the existing data on medical devices related to the MCM initiative through systematic evidence synthesis. Through this effort, a total product life cycle approach to evaluation of MCM-priority device safety and effectiveness can be utilized for regulatory and other scientific/clinical decision-making. In addition, administrative claims and electronic healthcare datasets will be evaluated for baseline clinical data with appropriate innovative methodologies with easy extension to follow-up and capture of data in the event of a CBRN event. The medical and scientific community will be engaged through dissemination of the findings. Experts will also be encouraged to provide their opinions through thinktanks. Leveraging the MDEpiNet partnership will provide a comprehensive approach to evaluating MCM-priority devices and radiological products prior to, during, and after a CBRN emergency.

There are 4 key project areas identified for this effort that must be addressed:

(1) Evidence Synthesis: Novel Approaches To Enhance Postmarket Evaluation of MCM-priority Medical Devices: develop evidence-based regulatory science for MCM-priority medical devices; develop a comprehensive and continually updated overview compiling all of the existing data for up to nine (9) medical device areas related to MCM critical to being fully informed in the event of CBRN agent events or when engaging any new potential projects for the initiative. This evaluation will include data from the pre-and postmarket FDA experience, published and unpublished literature, expert opinion, and use of innovative statistical techniques to synthesize all data into a manageable body of knowledge.

(2) Development of MCM-specific patient-centered comparative conceptual total product life cycle (TPLC) framework and patient-centered outcomes research: adapt the developed patient-centered comparative conceptual TPLC framework for MCM; apply the framework to evaluation of up to five (5) MCM-priority devices, including development of appropriate study designs and analytical strategies and application to CDRH regulatory decision-making.

(3) Innovative methodological approaches for MCM-priority medical devices: assess insurance claims data, electronic healthcare data, and other available data sources for determining utilization and outcomes associated with up to five (5) MCM-priority medical device areas; determine the gaps in available data within each MCM-priority device area; adapt and utilize novel methodologies within the existing data to fill the gaps and to provide useful utilization and outcomes data as a baseline for measuring the impact of any CBRN events.

(4) Scientific Infrastructure and Coordination of Stakeholder Meetings, Think Tanks, Workshops, and Dissemination of Findings: solicit and coordinate participation from collaborators, stakeholders, and external parties with relevant MCM expertise in up to ten (10) scientific think tanks, workshops, or conferences and coordinate dissemination of the results of projects performed in areas 1, 2, and 3 listed above via collaborative authorship and publication of reports, manuscripts, white papers, presentations at scientific conferences and other public communication efforts.

Through this effort, a total product life cycle approach to evaluation of MCM-priority device safety and effectiveness can be utilized for regulatory and other scientific/clinical decision-making. In addition, administrative claims and electronic healthcare datasets will be evaluated for baseline clinical data with appropriate innovative methodologies with easy extension to follow-up and capture of data in the event of a CBRN event. The medical and scientific community will be engaged through dissemination of the findings. Experts will also be encouraged to provide their opinions through thinktanks. Leveraging the MDEpiNet partnership will provide a comprehensive approach to evaluating MCM-priority devices and radiological products prior to, during, and after a CBRN emergency while improving the regulatory science infrastructure framework and methodology development.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications received. FDA/CDRH intends to commit up to $490,000 Total Costs (direct costs plus indirect cost) in Fiscal Year 2012.
Award Budget	Application budgets are not limited, but need to reflect actual needs of the proposed project. The amount of financial assistance requested from FDA may not exceed the following: Year 01: $490,000 Year 02: $500,000 Year 03: $550,000 Year 04: $560,000 Year 05: $580,000
Award Project Period	The total project period will be 5 years. An additional 4 years of support will be available depending upon fiscal year appropriations and successful performance. The total project period for an application requesting support may not exceed 5 years.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the HHS Grants Policy Statement, are allowed.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) 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
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD(s)/PI(s)) 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 4-6 weeks prior to the application due date.

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 SF 424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement. However, any level of cost sharing proposed by the applicant will be considered in the objective review process and will be a preference factor.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

All page limitations described in the SF424 Application Guide must be followed, with the following exceptions or additional requirements:

• For this specific FOA, the Research Strategy section is limited to 30 pages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

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 SF424 (R&R) Application Guide,.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign (non-US) institutions must follow policies described in the HHS Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, FDA’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness. Applications that are incomplete will not be forwarded for objective review.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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 biomedical and behavioral research are evaluated for scientific and technical merit through the FDA peer review system.

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).

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.

Significance

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 be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), 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?

Innovation

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?

Approach

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?

Environment

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?

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

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will generally evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation by primarily using the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials. If the research will ultimately support an application submitted to FDA or if the research is a clinical investigation regulated by FDA under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(i) and 360j(g)] then the research must comply with the human subject protections in 21 CFR parts 50 and 56,

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

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.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

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. Does the amount requested from FDA appear reasonable as partial support of the total work plan, facilities, staff, etc.? Is the budget organized, reasonable, and clearly stated? Does the budget account for the proposed work plan? Are indirect costs justified and reasonable in relation to the proposed work plan? Is there a cost sharing plan proposed? If a plan is proposed, is it a fixed percentage/amount, a minimum percentage/amount, or a graduated percentage/amount? Is it negotiable?

Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review Group(s) in accordance with FDA's Objective Review Policy and Procedures.

As part of the objective review process, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

Applications will be assigned to the appropriate FDA Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by objective review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the HHS Grants Policy Statement.

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’s business official.

Awardees must comply with any funding restrictions described in 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 as noted on the HHS Grants Policy Statement.

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) 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 PD(s)/PI(s) will have the primary responsibility for:

• The Principal Investigator/Program Director (PD/PI) 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 DHHS, PHS, and FDA policies.

FDA staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• An FDA Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
  
  The Project Scientist will monitor the project-related activities of the grantee periodically. The monitoring may be in the form of telephone conversations, emails, or written correspondence between the Project Scientist and the PD/PI. Periodic site visits with the PD/PI and other 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 Scientist. In addition,
  
  a. FDA will have prior approval of the appointment of all key administrative and scientific personnel proposed by the grantee.
  
  b. FDA will be directly involved in the guidance and development of the program.
  
  The FDA Project Scientist 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.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Parties will have equal representation on all steering, project, scientific, and other committees associated with work performed under this agreement. This representation will include equal voting rights on projects and processes related to work carried out under this agreement.
• Parties will act in good faith to recruit, develop, and maintain committee membership to include stakeholders representing sectors affected by the work performed under this agreement, e.g. academic investigators, medical device industry, healthcare providers, health care delivery organizations, professional organizations, and patient organizations. These additional members may have voting rights, where appropriate according to written governance documents developed under this agreement.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the FDA may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without FDA staff voting, one FDA designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.

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 FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on 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.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding FDA grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@FDA.gov

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)
TTY: 301-451-5939
Email: commons@od.FDA.gov

Mary Beth Ritchey
Center for Devices and Radiological Health(CDRH)
Telephone: 301-796-6638
Email: Maryelizabeth.Ritchey@fda.hhs.gov

Nilsa Loyo-Berrios

Center for Devices and Radiological Health(CDRH)
Telephone: 301-796-6065
Email: Nilsa.Loyo-Berrios@fda.hhs.gov

Benjamin Eloff
Center for Devices and Radiological Health(CDRH)
Telephone: 301-796-8528
Email: Benjamin.Eloff@fda.hhs.gov

Lisa Ko
Office of Acquisitions and Grants Services(OAGS)
Telephone: 301-827-5095
Email: Lisa.Ko@fda.hhs.gov

Lisa Ko
Office of Acquisitions and Grants Services(OAGS)
Telephone: 301-827-5095
Email: Lisa.Ko@fda.hhs.gov

Recently issued trans-FDA policy notices may affect your application submission. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.