Department of Health and Human Services

Part 1. Overview Information
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

Enhancing post-market surveillance through developing registries for medical device epidemiology (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.
  • August 28, 2012 - See Notice NOT-FD-12-022. Notice of Change to Funds Available, Anticipated Number of Awards and Award Budget.
  • August 1, 2012 - See Notice NOT-FD-12-021. Notice of Correction to Expiration Date.

Funding Opportunity Announcement (FOA) Number

RFA-FD-12-028

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.103 

Funding Opportunity Purpose

(1) To develop registries and consortia in key medical device areas to implement new registry methodologies that strategically broaden the scope of the US and international postmarket surveillance system, and

(2) To address identified gaps in the current postmarket surveillance system by developing new methodologies for registry data collection and linkage, or by adapting known methodologies to medical devices, and

(3) To develop novel methodology that allows for use of the registry data collection infrastructure to serve multiple purposes including postmarket surveillance, device tracking through Unique Device Identifiers (UDI), prospective embedded studies, quality improvement, and other uses.

Key Dates
Posted Date

May 15, 2012

Open Date (Earliest Submission Date)

May 21, 2012

Letter of Intent Due Date

June 1, 2012

Application Due Date(s)

June 25, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

July 2012

Advisory Council Review

August 2012

Earliest Start Date(s)

September 2012

Expiration Date

(Corrected to June 26, 2012 per NOT-FD-12-021), Originally June 26, 2016

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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

To meet FDA's goal of ensuring safety and effectiveness of medical devices post-approval, FDA relies on medical device registries as a critical source of information for active postmarket surveillance. As the follow-up data from premarket studies is rather limited related to the use of the devices postmarket, registries also allow for the collection of longer term device evaluation in the populations using the device. This continued data collection provides the FDA with early safety signals.

Medical device registries collect data on patients, including data as indicated above, with a population of patients who have been exposed to a medical device.  Medical device postmarket surveillance presents unique challenges, related to the diversity and complexity of these products, the iterative nature of product development, the learning curve associated with technology adoption, and the relatively short, product life-cycle.  For these reasons, CDRH/FDA currently uses registries to assess the real-world performance of medical products and procedures, including registry data, to determine the clinical effectiveness and safety of a test, medical device, procedure, or treatment, to describe the natural history of a problem or disease, and to examine trends of disease, treatment, or product use over time. 

The purpose of this FOA is to facilitate development of registries and consortia of registries for key medical device areas as part of FDA's strategic postmarket surveillance effort.  FDA must meet the need of active post-marketing surveillance of priority medical device types as advances in medical science deliver an increasing amount of cleared and approved medical devices. The continued development of registries such as these will allow the FDA to gather data on safety and effectiveness of both pre-existing and newly marketed medical devices in the population. These registries can be used to evaluate data on indications, procedural performance, and outcomes utilizing standardized forms which can then be used for all subsequent device iterations.

Specifically, the aims of this FOA are to:

(1) To develop registries and consortia in key medical device areas to implement new registry methodologies that strategically broaden the scope of the US and international postmarket surveillance system, and

(2) To address identified gaps in the current postmarket surveillance system by developing new methodologies for registry data collection and linkage, or by adapting known methodologies to medical devices, and

(3) To develop novel methodology that allows for use of the registry data collection infrastructure to serve multiple purposes including postmarket surveillance, device tracking through Unique Device Identifiers (UDI), prospective embedded studies, quality improvement, and other uses.

The MDEpiNet partnership can be used to develop new registries to track and report usage and subsequent clinical outcomes associated with marketed medical devices. It is expected that the registries developed through this program will not only support FDA's postmarket surveillance program, but also provide important and timely information to patients, healthcare providers, insurers, and the medical device industry to advance medical device development and improve public health.  By leveraging the MDEpiNet partnership, it is expected that the regulatory science advances in infrastructure and methodology associated with this registry development will be applicable to a broad range of medical device areas and that this work will advance regulatory science to strengthen overall medical device lifecycle performance evaluation capabilities.

All registries developed as a part of this project should take the following into account:

1. Registries should be developed in such a way to support embedding of prospective clinical trials.  Subsequent trials may be designed to support mandated postmarket studies, premarket studies, and other independent scientific investigation;

2. The scientific plan for developing a registry should be accompanied by a plan or framework for establishing a sustainable partnership business infrastructure to allow for substantial national or international coverage over an extended period of time;

3. While periprocedural data is vital to the understanding of medical device use, longitudinal follow-up capabilities should be also addressed;

4. The use of registries is expanding resulting in increased cost to hospitals, providers, and ultimately patients.  Registry development efforts should use information technology infrastructure to reduce the resource burden while maintaining high data quality;

5. Proposals should include details on how patient privacy and data security will be established and maintained;

6. Registries should incorporate unique device identifiers (UDI) to allow for adequate tracking and investigation into potential postmarket signals;

7. Proposals should include details regarding data access and availability to all stakeholders and partners, including FDA (for research purposes as well as under the FDA authority for surveillance monitoring to protect the public health);

8.  The incorporation of multiple registries into consortia is increasing.  Proposals including development or maintenance of registry consortia should include details regarding where data will be housed (i.e. at each registry for a distributed data approach or in a central repository) and how the data across the registries will be complied for analysis (e.g. common data model).

9. Proposed development projects should address one or more gaps in registry methodology, technical infrastructure, or in an underserved medical device area.

FDA's current priorities for registry development are available on the program website at: http://www.fda.gov/MDEpiNet.  

Section II. Award Information
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.  FDA intends to commit up to $250,000 in Fiscal Year 2012. Future year amounts will depend on annual appropriations.

It is anticipated that up to two (2) awards will be made, not to exceed $125,000 in total costs (direct plus indirect) per award, per year.

Funding will be provided for one year, with the possibility of up to four years of additional support, contingent on performance and continued availability of federal funds.

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 $125,000 per year.

Award Project Period

Awards in support of projects will be made for a project period commensurate with the time involved in planning and conducting the project.  Typically, this will be one year.  Applicants may propose a multi-year project period, up to 5 years.

The availability of funding for subsequent years of multi-year project periods depends on annual appropriations and grantee 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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

Awards made under this announcement will be supported using Critical Path funds as described in Section 566 of the Federal Food Drug and Cosmetic Act (FD&C Act).  Section 566(b) of the FD&C Act defines eligible entities as (A) an institution of higher education (as such term is defined in section 101 of the Higher Education Act of 1965 [20 USC § 1001]) or a consortium of such institutions; or

(B) an organization described in section 501(c)(3) of the Internal Revenue Code of 1986 [26 USC § 501(c)(3)] and exempt from tax under section 501(a) of such Code [26 USC § 501(a)].

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.

Required Registrations

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.

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.

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 SF 424 (R&R) Application Guide.   

2. Cost Sharing

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.

3. Additional Information on Eligibility

Number of Applications

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.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows FDA staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent electronically to:

Lisa Ko
Grants Management Specialist
Email: Lisa.Ko@fda.hhs.gov

Required and Optional Components

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.

Page Limitations

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

PHS 398 Research Plan Component

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, with the following modification:

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.

3. Submission Dates and Times

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.

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 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.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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.

Overall Impact

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

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(s)/PI(s), 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?

Additional Review Criteria

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

Additional Review Considerations

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

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?   

2. Review and Selection Process

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, using the stated review criteria.

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted in 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:

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information

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’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 in the HHS Grants Policy Statement.

2. Administrative and National Policy Requirements

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:

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

Areas of Joint Responsibility include:

3. Reporting

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. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

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 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.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.nih.gov

Scientific/Research Contact(s)

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

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

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.

Authority and Regulations

Awards are made under the authorization of Section 566 of the Federal Food, Drug, and Cosmetic Act (21 USC 360bbb-5) and Section 301 of the Public Health Service Act (PHS Act) as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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