Participating Organization(s)	U.S. Food and Drug Administration (FDA) NOTE: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH. Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA 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 Objective Review Process.
Components of Participating Organizations	Office of Regulatory Affairs (ORA)
Funding Opportunity Title	Conformance with the Manufactured Food Regulatory Program Standards (MFRPS) (U18)
Activity Code	U18 Research Demonstration - Cooperative Agreements
Announcement Type	New
Related Notices	August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
Funding Opportunity Announcement (FOA) Number	PAR-13-164
Companion Funding Opportunity	None
Number of Applications	Only one application per institution is allowed, as defined in Section III.3. Additional Information on Eligibility
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.103
Funding Opportunity Purpose	The intended outcome of this FOA is to advance efforts for a nationally integrated food safety system by assisting State manufactured food regulatory programs to achieve and maintain full conformance with the Manufactured Food Regulatory Program Standards (MFRPS). The MFRPS are intended to ensure that State manufactured food regulatory programs develop and maintain best practices for a high-quality regulatory program. Also, the program standards are intended to enhance food safety by establishing a uniform basis for measuring and improving the performance of manufactured food regulatory programs in the United States. Conformance with these program standards will help Federal and State agencies better direct their regulatory activities at reducing foodborne illness hazards in plants that manufacture, process, pack, or hold foods. In addition, State manufactured food regulatory programs expected to achieve significant to full conformance with the MFRPS before Year 5 of the cooperative agreement should choose to develop and implement Standard Enhancement Projects (SEPs). The SEPs will further enhance the capacity of the State manufactured food regulatory program to protect public health and safeguard the food supply.

Posted Date	March 29, 2013
Open Date (Earliest Submission Date)	April 15, 2013
Letter of Intent Due Date(s)	April 19, 2013 April 18, 2014 April 17, 2015
Application Due Date(s)	June 4, 2013, 2014 and 2015 by 11:59PM Eastern time. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	July 2013, 2014, 2015
Advisory Council Review	Not Applicable
Earliest Start Date	August 2013, 2014, 2015
Expiration Date	June 5, 2015
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the HHS Grants Policy Statement). 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

a. Program Objectives

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) is announcing the availability of up to $4,500,000 to be awarded under Limited Competition to State manufactured food regulatory programs. The intended outcome of this FOA is to advance efforts for a nationally integrated food safety system through the conformance and advancement of the Manufactured Food Regulatory Program Standards (MFRPS) by State manufactured food regulatory programs.

The MFRPS allows for the development of risk-based food safety programs by establishing a uniform basis for measuring and improving the performance of State manufactured food regulatory programs in the United States. By achieving and sustaining conformance with these program standards, food safety programs of Federal and State regulatory agencies can better direct their regulatory activities toward reducing foodborne illness hazards in food plants. Consequently, the safety and security of the United States food supply will improve.

The program standards are comprised of ten standards that establish requirements for the critical elements of a regulatory program designed to protect the public from foodborne illness and injury. These elements include the program’s regulatory foundation, training program, inspection program, inspection audit program, food-related illness outbreak response, compliance and enforcement, industry and community relations, program resources, program assessment, and laboratory support.

Achieving and sustaining conformance with the program standards will require comprehensive self-assessment on the part of a State program and will encourage continuous improvement and innovation. FDA recognizes that the time required for full conformance of the program standards will vary between States. However, all State manufactured food regulatory programs will be expected to implement strategic plans to ensure continuous improvement and demonstrate that they are moving towards full conformance. State manufactured food regulatory programs receiving funds under this cooperative agreement will be expected to achieve significant to full conformance by Year 5 of the cooperative agreement.

For the purpose of this funding opportunity, full conformance is accomplished if the State manufactured food regulatory program has policies and procedures in place that meet all of the MFRPS requirements and the program uses the policies and procedures as written for all program elements and documentation requirements within each standard. Significant conformance is accomplished if the State manufactured food regulatory program has policies and procedures in place that meet 80% or more of the individual program elements within each of the ten standards of the MFRPS and the program uses the policies and procedures as written for all elements and documentation requirements within each standard; and if, for those individual program elements not met, the state program has a detailed strategic plan on how the remaining MFRPS elements and documentation requirements not yet met will be fully implemented and demonstrate. The strategic plan will include: A detailed timeline including what needs to be accomplished to implement the element and/or documentation requirement, who will be doing the work, and when the work will be completed.

In addition, some programs are expected to achieve significant to full conformance with the MFRPS before Year 5 of entering into enrollment of the standards or the cooperative agreement based on previous enrollment in the MFRPS and current level of conformance. Programs expected to be in significant to full conformance with the MFRPS before Year 5 of the cooperative agreement, including those programs funded under the Rapid Response Team and Program Infrastructure Improvement Implementation Project, may choose to apply for less than 5 years of funding or to develop and implement Standard Enhancement Projects (SEPs). The SEPs should be related to standards with which the State program is in significant to full conformance. The SEPs are designed to help the State move their program further into public health protection and enhance the capacity they have established through conformance with a standard. The SEPs will also help to advance the MFRPS and integration of the national food safety system. The SEPs will vary in design, scope, and complexity. Possible project areas include: environmental sampling, collaboration through IT information sharing, Rapid Response Team (RRT) prototypes, risk based modeling, FDA recognized State trainers, community outreach to targeted audiences, and innovative methods to capture, document, analyze and trend consumer complaint or enforcement action.

Although individual year outcomes may vary among programs, the overall outcomes of the work provided under this multi-year cooperative agreement are as follows:

1. State manufactured food regulatory programs will achieve and sustain significant to full conformance with the Manufactured Food Regulatory Program Standards (MFRPS), which is recognized as a critical element to creating a national, fully integrated food safety system.

2. State manufactured food regulatory programs will contribute to the continuous improvement of the MFRPS through attendance at an annual face-to-face meeting, active participation in committees, and other initiatives supporting the MFRPS.

3. Develop strategies for achieving and sustaining conformance with the MFRPS that can be duplicated on a national basis.

4. Provide FDA the foundation for pursuing regulatory action based upon the findings of State manufactured food regulatory programs.

5. Provide the State manufactured food regulatory program the ability to further enhance capability and protect public health through the development and implementation of Standard Enhancement Projects (SEPs).

b. Eligible Entities

Only State manufactured food regulatory programs with current FDA food safety inspection contracts (providing funding to State agency food protection regulatory programs) in satisfactory standing, or those that meet the eligibility requirements and agree to enter into a food safety inspection contract with FDA at the earliest possible date, are eligible to apply for funding under this cooperative agreement. A condition of the award will be maintaining a current food safety inspection contract in satisfactory standing with FDA throughout the cooperative agreement project and budget periods.

c. Technical Review

A technical review session will be held for prospective grantees in April/May 2013, 2014, 2015. The conference call information will be provided to prospective grantees that submit a letter of intent. The technical review session will provide an overview of the submission requirements and allow prospective grantees an opportunity to ask questions regarding the application process. Participation in the technical review session is optional, but strongly encouraged.

d. Funding

The FDA will provide one year of funding with the possibility of up to four years of additional, non-competitive support, contingent on performance and continued availability of federal funds. Application budgets are limited to $300,000 (direct and indirect costs) per year of funding requested and must reflect the actual needs of the proposed project.

These funds are intended to supplement, not replace, State funding for program improvement and activities. State manufactured food programs funded under these cooperative agreements will be required to provide the previous, current, and subsequent years of State funding to demonstrate that these funds have not replaced State allocations.

In addition, work proposed under this cooperative agreement may not be duplicated or funded by other cooperative agreements, contracts, or other funding mechanisms. Projects proposed under these cooperative agreements and the funding provided must remain distinct and separate from other projects and funding sources. The grantee must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, received through contracts, cooperative agreements, grants, and other funding received by the grantee and these cooperative agreements.

Background

a. FDA Food Protection Plan

Although the United States has one of the safest food supplies in the world, the public health burden of foodborne disease in the nation is substantial. CDC estimates that each year roughly 1 in 6 Americans (or 48 million people) gets sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases http://www.cdc.gov/foodborneburden/. New challenges continue to arise, including the globalization of the food supply and the emergence of new pathogens in foods. "Food" includes human food and animal feed and is defined in 21 USC 321(f)).

In May 2007, Secretary of Health and Human Services, Michael O. Leavitt and Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs, charged FDA with developing a comprehensive and integrated FDA Food Protection Plan to keep the nation's food supply safe from both unintentional and deliberate contamination. Driven by science and modern information technology, the Plan aims to identify potential hazards and counter those before they can do harm. A cornerstone of this forward-thinking effort is an increased focus on prevention.

The Plan builds in safety measures to address risks throughout a product’s life cycle, from the time a food is produced to the time it is distributed and consumed. The Plan focuses FDA efforts on preventing problems first, and then uses risk-based interventions to ensure preventive approaches are effective. The Plan also calls for a rapid response as soon as contaminated food or feed is detected or when there is harm to people or animals.

FDA’s integrated approach, within the Food Protection Plan, encompasses three core elements: prevention, intervention and response.

b. President’s Food Safety Working Group

An indication of the significant, national interest in food safety is the President’s Food Safety Working Group (FSWG), initiated in March of 2009 (http://www.foodsafetyworkinggroup.gov/Home.htm). The charge of the FSWG is the following: To have safe food that does not cause us harm and to enhance our food safety systems by fostering coordination throughout the government including enhancing our food safety laws for the 21st century. These laws will be designed to keep the American people safe and will be enforced. Chaired by the Secretary of Health and Human Services and the Secretary of Agriculture, the FSWG recommends a public health-focused approach to food safety that prioritizes prevention, strengthens surveillance and enforcement, and improves response and recovery.

c. National Integrated Food Safety System

FDA is continuing to work with its state partners to create a national, fully integrated food safety system that is characterized by effective communication and efficient processes among federal, state, and local partners in the food safety system. Various initiatives, such as the Food Protection Task Force Program, Innovative Food Defense Program, Rapid Response Team Program, and the programs supported by these cooperative agreements, work to engage partners across multiple sectors of the food safety system to collaborate to identify means to improve and optimize the nation’s food safety system.

d. Food Safety Modernization Act

FSMA, signed into law on January 4, 2011, provides FDA with tools to better protect public health by strengthening the food safety system. It enables FDA to focus on preventing food safety problems rather than reacting to problems after they occur. FSMA directs FDA to build an integrated national food safety system in partnership with State, local, territorial, and tribal authorities, explicitly recognizing that all food safety agencies need to work together in an integrated way to achieve national public health goals. FSMA identifies some key priorities in working with partners in areas, such as: reliance on Federal, State, and local agencies for inspections; improving foodborne illness surveillance; and leveraging and enhancing State and local food safety and defense capacities. Full text of the law: http://www.fda.gov/Food/FoodSafety/FSMA/ucm247548.htm

e. Bioterrorism Act

Alongside the increased national focus on food safety has been the increased focus on emergency preparedness and response since 2001. The events of September 11, 2001, reinforced the need to enhance the safety and defense of the U.S. food supply. Congress responded by passing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ("Bioterrorism Act"), which President Bush signed into law on June 12, 2002. The Bioterrorism Act is divided into five titles, detailed here: http://www.fda.gov/regulatoryinformation/legislation/ucm148797.htm.

f. Food and Drug Administration Amendments Act of 2007 (FDAAA)

FDAAA amended the FD&C Act to require FDA to work with the States to undertake activities to assist in improving food safety. This requirement is contained within Title X (Food Safety) Section 1004 of the FDAAA (Full text: http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/html/PLAW-110publ85.htm).

g. Import Safety Action Plan

The Import Safety Action Plan acknowledges the value of mutual leveraging of State and Federal resources and recommends consideration of cooperative agreements to increase information sharing. Specifically, the ISAP contains Recommendation 12 to maximize federal-state collaboration for federal-state rapid response (http://archive.hhs.gov/importsafety/report/actionplan.pdf; pages 37-38).

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 SF424 (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 fund an estimate of 15 awards, corresponding to a total of $4,500,000, for fiscal year 2013. Future year amounts will depend on annual appropriations and performance.
Award Budget	Application budgets are limited to $300,000 (direct and indirect costs) and need to reflect actual needs of the proposed project.
Award Project Period	The total project period for an application requesting support may not exceed five years.

HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

This opportunity is only available to the following State government food safety programs: State manufactured food regulatory programs with current FDA food safety inspection contracts (providing funding to State agency food protection regulatory programs), or those that meet the eligibility requirements and agree to enter into a food safety inspection contract with FDA at the earliest possible date. Competition is limited to these State manufactured food regulatory programs because the foundational work conducted under the current FDA food safety inspection contracts is necessary for the completion of significant improvements in a nationally integrated food safety system.

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.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 HHS 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 SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.

Only one application per institution (normally identified by having a unique TIN number) is allowed.

FDA will not accept any application in response to this FOA that is essentially the same as one currently pending initial objective 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.

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:

• Descriptive title of proposed research
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent by email to: wendy.campbell@fda.hhs.gov and Oluyemisi.Akinneye@fda.hhs.gov.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirement:

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

The forms package associated with this FOA includes all applicable components, required 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 instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

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

Specific Aims: None

Research Strategy: None

Letters of Support: None

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 modifications:

• Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

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.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to 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. eRA Commons and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the deadline 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.

Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

These awards may only be used for achieving and sustaining conformance with the MFRPS and the development and implementation of Standard Enhancement Projects (SEPs) within State manufactured food regulatory programs currently under contract, or will be entering into a contract at the earliest possible date, with the FDA to perform food safety inspections.

Allowable costs include:

1) Audiovisual materials such as videotapes, DVDs, public service announcements, etc.

2) Consultant services

3) Employee salaries, wages and fringe benefits

4) Rental, purchasing, calibration, and maintenance of supplies and equipment

5) Indirect costs

6) Recruitment costs for hiring new employees

7) Registration fees

8) Purchase or development of IT equipment, software, and support

9) Shipping and mailing of equipment and supplies

10) Travel

11) Speaker fees

12) Subcontracting to third parties (other than local/county/tribal agencies conducting work on behalf of the State manufactured food regulatory agency) is allowed but limited to 25% of each year's award.

Non-allowable costs:

1) Facilities, work, and training reimbursed under the FDA food safety inspection contract and other funding mechanisms must remain distinct and separate from the cooperative agreement. The State must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, under the food safety inspection contracts and other funding mechanisms and these cooperative agreements.

2) Vehicle purchases are not permitted.

3) Cooperative agreement funds may not be utilized for new building construction; however, remodeling of existing facilities is allowed, provided that remodeling costs do not exceed 10% of the grant award amount.

4) Please also refer to the HHS Grants Policy Statement for additional information regarding costs.

Funding Plan: Funding for years 2 through 5 will be noncompetitive continuation of support and depend on performance, program progress, and the availability of Federal funds. Funds should be requested in the budget for key project personnel to travel to meetings, on-site visits, and audits with FDA program staff to discuss the project. A portion of budgeted travel funds should also be set aside for key personnel to attend an annual face-to-face meeting (as determined by FDA) and committee meetings supporting the MFRPS. Training needs should also be anticipated and budgeted for accordingly.

Applications must be submitted electronically following the instructions described in the SF424 (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 SF424(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 System for Award Management (SAM). 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 by the Office of Acquisition and Grants (OAGS) and responsiveness by the FDA Office of Regulatory Affairs (ORA). Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the Project Officer by email at wendy.campbell@fda.hhs.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, applicant organization name and title of the application.

The applicant must specifically address the ability to achieve the following objectives in the cooperative agreement:

1) Demonstrate the ability to develop and implement a comprehensive strategic plan that will result in significant to full conformance with the MFRPS and sustainability after the cooperative agreement.

2) Demonstrate the ability to develop and implement SEPs to further enhance the capacity of the State manufactured food regulatory program to protect public health and safeguard the food supply, if pursued.

3) Demonstrate the ability to fully participate in initiatives supporting the MFRPS, such as an annual face-to-face meeting (as determined by FDA), committees, MFRPS conference calls, sharing of best practices, annual on-site visits, program assessment validation audits (PAVA), and full program audits.

4) Demonstrate the availability of adequately trained staff and the criteria and ability to hire and/or train personnel to meet the deliverables of the cooperative agreement.

5) Provide a properly detailed budget (one for each of the five years) that is intended to achieve conformance with the MFRPS. For applicants that choose to pursue SEPs, the budget should include funds for developing and implementing the SEPs.

6) Demonstrate the ability to satisfy the reporting requirements outlined in section VI.3 of this announcement.

7) Provide the previous year and current funding level certification for the manufactured food regulatory program from State funding appropriations.

8) Outline a detailed methodology for program assessment, improvement, and collaboration to accomplish the work, as described in this announcement, and ensure program sustainability.

9) Provide justification for hiring new staff, including qualifications, training needs, and new equipment needs.

For applicants enrolled in the MFRPS for a minimum of 12 months, a copy of the program self-assessment, strategic plan, and a description of the progress and accomplishments of the program in achieving conformance with the MFRPS shall be included in the application. The program self-assessment and strategic plan should be included as appendices following the directions in the SF-424 Guide. Also, applicants enrolled in the MFRPS for a minimum of 12 months must describe any identified or potential obstacles in achieving and sustaining significant to full conformance with the MFRPS and approaches to overcome these obstacles.

The FDA recognizes that achieving significant to full conformance with the MFRPS will vary by program based on multiple factors, such as previous enrollment in the MFRPS and current level of conformance.

Applicants, including programs funded under the Rapid Response Team and Program Infrastructure Improvement Implementation Project, that are expected to achieve significant to full conformance prior to Year 5 of the cooperative agreement, may choose to apply for less than 5 years of funding or to propose Standard Enhancement Projects (SEPs) to further enhance the capacity of the State manufactured food regulatory program to protect public health and safeguard the food supply. These applicants should propose project milestones based upon their previous enrollment, current level of conformance, and the SEP proposed, if applicable.

The project milestones provided below are suggested for new programs enrolling in the MFRPS who have never completed and submitted a baseline MFRPS self-assessment to FDA:

Year 1:

1. The State manufactured foods program must agree to enter into a food safety inspection contract with the FDA at the earliest possible date if not under a current food safety inspection contract. A current food safety inspection contract must be maintained throughout the cooperative agreement.

2. Participation in an on-site visit consisting of key State food regulatory program and FDA personnel to discuss the requirements of the MFRPS. Participation includes providing meeting space, accessibility of key State food regulatory program management and staff, and access to records, databases, and other materials supporting MFRPS conformance.

3. Attendance and participation of key State manufactured food program managers and staff in an annual face-to-face meeting, committee meetings, and other initiatives supporting national and program specific conformance with the MFRPS.

4. Conduct a comprehensive baseline self-assessment, including completion of all applicable appendices, worksheets, and other documents (or equivalent documents), required in each Standard.

5. New programs will develop a strategic plan that will result in significant to full conformance with Standard 9 by year 1, full conformance with the MFRPS by Year 5 of the cooperative agreement, and meet SEP deliverables in their application, if included. Programs with previously developed strategic plans and/or a SEP shall update their plans as necessary to achieve or sustain conformance with MFRPS (including Standard 9 in year 1) and meet SEP deliverables in their application if included. The strategic plan shall include the following, at a minimum:

a. Specific objectives and tasks that once completed and/or implemented, will result in achievement or maintenance of full conformance with the MFRPS and completion of SEP.

b. Timelines, responsible personnel, and dedication of any additional resources assigned to each objective and task.

c. Identification of objectives and/or tasks completed during the current project year

d. An assigned MFRPS Project Coordinator with the overall responsibility for implementing the strategic plan.

e. Complete the applicable appendices provided in the Standards 1-10 as referenced in Section IV-3 Reporting.

Year 2:

1. Participation in an outreach training session led by FDA consisting of key State food regulatory program and FDA personnel to discuss the requirements of the MFRPS. Participation includes providing meeting space, accessibility of key State food regulatory program management and staff, and access to records, databases, and other materials supporting MFRPS conformance.

2. Attendance and participation of key State manufactured food regulatory program managers and staff in an annual face-to-face meeting, committee meetings, and other initiatives supporting national and program specific conformance with the MFRPS.

3. Implementation of the strategic plan. The strategic plan is updated to accurately reflect when specific objectives and tasks have been met and when new objectives and tasks are identified to achieve full conformance with the MFRPS and SEP. Progress achieved indicates significant to full conformance with the MFRPS can be expected by Year 5. The strategic plan includes the following, at a minimum:

a. Specific objectives and tasks that once completed and/or implemented, will result in achievement or maintenance of full conformance with the MFRPS and completion of SEP.

b. Timelines, responsible personnel, and dedication of any additional resources assigned to each objective and task.

c. Identification of objectives and/or tasks completed during the current project year.

d. An assigned MFRPS Project Coordinator with the overall responsibility for implementing the strategic plan.

e. Update and maintain current and fit for use the applicable appendices in Standards 1-10 as referenced in Section IV-3 Reporting

Year 3:

1. Participation in an outreach training session led by FDA consisting of key State food regulatory program and FDA personnel to discuss the requirements of the MFRPS. Participation includes providing meeting space, accessibility of key State food regulatory program management and staff, and access to records, databases, and other materials supporting MFRPS conformance.

2. Attendance and participation of key State manufactured food regulatory program managers and staff in an annual face-to-face meeting, committee meetings, and other initiatives supporting national and program specific conformance with the MFRPS.

3. Implementation of the strategic plan. The strategic plan is updated to accurately reflect when specific objectives and tasks have been met and when new objectives and tasks are identified to achieve full conformance with the MFRPS and SEP. Progress achieved indicates significant to full conformance with the MFRPS can be expected by Year 5. The strategic plan includes the following, at a minimum:

a. Specific objectives and tasks that once completed and/or implemented, will result in achievement or maintenance of full conformance with the MFRPS and completion of SEP.

b. Timelines, responsible personnel, and dedication of any additional resources assigned to each objective and task.

c. Identification of objectives and/or tasks completed during the current project year.

d. An assigned MFRPS Project Coordinator with the overall responsibility for implementing the strategic plan.

e. Update and maintain current and fit for use the applicable appendices in Standards 1-10 as referenced in Section IV-3 Reporting.

Year 4:

1. Attendance and participation of key State manufactured food regulatory program managers and staff in an annual face-to-face meeting, committee meetings, and other initiatives supporting national and program specific conformance with the MFRPS.

2. Participation in an outreach training session led by FDA consisting of key State food regulatory program and FDA personnel to discuss the requirements of the MFRPS. Participation includes providing meeting space, accessibility of key State food regulatory program management and staff, and access to records, databases, and other materials supporting MFRPS conformance.

3. Implementation of the strategic plan. The strategic plan is updated to accurately reflect when specific objectives and tasks have been met and when new objectives and tasks are identified to achieve full conformance with the MFRPS. Progress achieved should indicate significant to full conformance with the MFRPS can be expected by Year 5. The strategic plan should include the following, at a minimum:

a. Specific objectives and tasks that once completed and/or implemented, will result in full conformance with the MFRPS.

b. Timelines, responsible personnel, and dedication of any additional resources assigned to each objective and task.

c. An assigned MFRPS Project Coordinator with the overall responsibility for implementing the strategic plan.

Year 5:

1. Attendance and participation of key State manufactured food regulatory program managers and staff in an annual face-to-face meeting, committee meetings, and other initiatives supporting national and program specific conformance with the MFRPS.

2. Participation in an outreach training session led by FDA consisting of key State food regulatory program and FDA personnel to discuss the requirements of the MFRPS. Participation includes providing meeting space, accessibility of key State food regulatory program management and staff, and access to records, databases, and other materials supporting MFRPS conformance.

3. Development of a plan identifying personnel, funding, and resources necessary to sustain significant to full conformance with the MFRPS after the end of the project period. Plan includes a root cause analysis and steps to address objectives and tasks that the program has determined they are unable to meet by Year 5.

4. Implementation of the strategic plan. The strategic plan is updated to accurately reflect when specific objectives and tasks have been met and when new objectives and tasks are identified to achieve full conformance with the MFRPS. Progress achieved indicates significant to full conformance with the MFRPS can be expected by Year 5. The strategic plan includes the following, at a minimum:

a. Specific objectives and tasks that once completed and/or implemented, will result in achieving or maintaining full conformance with the MFRPS by Year 5 and completion of the SEP.

b. Timelines, responsible personnel, and dedication of any additional resources assigned to each objective and task.

c. Identification of objectives and/or tasks completed during the current project year

d. An assigned MFRPS Project Coordinator with the overall responsibility for implementing the strategic plan.

e. Update and maintain current and fit for use the applicable appendices in Standards 1-10 as referenced in Section IV-3 Reporting.

The applicant must participate in a program assessment validation audit (PAVA) as coordinated and conducted by FDA. Upon completion of Year 5 enrollment in the MFRPS, the application must participate in a comprehensive audit of the State manufactured food program to verify significant to full conformation with the MFRPS. Participation in the PAVA and comprehensive audit includes providing meeting space, accessibility of key State food program management and staff, and access to records, databases, and other materials supporting MFRPS conformance. The audit should reveal that FDA agrees with the program's self assessments and strategic plan. Audit findings and corrective actions if necessary, are addressed in the strategic plan by the program.

The application must demonstrate that the funds from this cooperative agreement shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this funding opportunity announcement. The applicant must provide assurance that plans have been developed to engage in the types of activities outlined in the grant application using these grant funds, an itemization of how grant funds will be expended, a description of how grant activities will be monitored, and ability to report information required by the Secretary to conduct evaluations.

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

Acceptable post submission materials include:

• Revised budget pages
• Biographical sketches
• Letters of support or collaboration resulting from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator.
• News of an article accepted for publication (a copy of the article should not be sent).

Only the review criteria described below will be considered in the review process. All applications submitted to the FDA in support of this announcement 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.

1. The rationale and design to achieve the goals and project milestones of the cooperative agreement and project proposed (weight = 40%)

2. Demonstration of effectiveness in working with federal, state, and local partners and other appropriate organizations to implement the goals of the cooperative agreement (weight = 20%)

3. Demonstration of plans to facilitate the incorporation and sustainability of project developed capabilities into the entity's food safety system. Expected challenges should be documented and addressed (weight = 20%)

4. Demonstration of adequate program resources (including staff) and infrastructure, or the ability to obtain the resources necessary, to complete the project needs (weight = 20%)

Note: Only the Scored Review Criteria (criteria 1-4) will be used for scoring during the review of applications for this announcement. Reviewers may consider additional criteria described in the "Overall Impact" and Additional Review Considerations sections, as they relate to the criteria described above. Separate scores will not be given for the additional criteria.

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 score.

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 project activities.

Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review Panel, in accordance with FDA objective review policy and procedures, using the stated review criteria.

As part of the objective review, all applications:

• Will receive a written critique.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate FDA Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. 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 review of the application is completed, the PD/PI will receive his or her Summary Statement (written critique) via email.

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, SAM Registration, and Transparency Act requirements as noted in 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

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.

Support will be in the form of a cooperative agreement. Substantive involvement by the awarding agency is inherent in the cooperative agreement award. Accordingly, FDA will have substantial involvement in the program activities of the project funded by the cooperative agreement.

Substantive involvement includes, but is not limited to, the following:

• FDA hosting annual meetings for programs enrolled in the MFRPS.
• FDA conducting on-site technical sessions with the grantee.
• FDA conducting on-site visits PAVAs and program audits to verify grantee progress in achieving conformance with the MFRPS.
• FDA hosting monthly (or at a frequency chosen by FDA) conference calls/webinar meetings with all programs enrolled in the MFRPS.
• FDA assistance in the sharing of information developed by the grantee to achieve conformance with the MFRPS and pursue SEPs with other programs enrolled in the MFRPS in addition to FDA and other federal agencies. Examples may include SOPs, MOUs, training programs, and record keeping systems.
• FDA assistance in coordinating multi-program pilot projects.

The program project officer will monitor the recipient periodically. The monitoring may be in the form of telephone conversations, e-mails, or written correspondence between the project officer/grants management officer and the principal investigator. Periodic site visits with officials of the recipient organization may also occur. There may be other regular meetings with recipients to assist in fulfilling the requirements of the cooperative agreement.

The purpose of these cooperative agreements is to advance efforts for a nationally integrated food safety system by assisting State manufactured food regulatory programs to achieve and maintain full conformance with the MFRPS. The MFRPS are intended to ensure that State manufactured food regulatory programs develop and maintain best practices for a high-quality regulatory program. In addition, State manufactured food regulatory programs expected to achieve significant to full conformance with the MFRPS before Year 5 of the cooperative agreement may choose to apply for less than 5 years of funding or develop and implement SEPs. The SEP will further enhance the capacity of the State manufactured food regulatory program to protect public health and safeguard the food supply. The cooperative agreements will provide funding for ad ditional personnel, equipment, supplies, and training to support activities related to achieving conformance with the MFRPS and implementation of SEPs, if pursued.

The grantee must maintain a food safety inspection contract in satisfactory standing with the FDA throughout the cooperative agreement. State manufactured food programs funded under these cooperative agreements will be required to provide the previous, current, and subsequent years of State funding to demonstrate that these funds have not replaced State allocations. Key personnel (minimum of 2) will attend an annual face-to-face meeting (as determined by FDA) as a condition of the award. Facilities, work, and training reimbursed under the FDA food safety inspection contract and other funding mechanisms must remain distinct and separate from the cooperative agreement. The grantee must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, under the food safety inspection contracts and other funding mechanisms and these cooperative agreements.

Future funding will be dependent on recommendations from the Project Officer. The scope of the recommendation will confirm that acceptable progress has been made in achieving and maintaining conformance with the MFRPS, implementation of SEPs (if pursued), continued compliance with all FDA regulatory requirements and conditions of the award, and, if necessary, a corrective action plan has been implemented. Specific project milestones, reporting requirements, and other project deliverables may be included as a condition of your award.

In addition, work proposed under this cooperative agreement may not be duplicated or funded by other cooperative agreements, contracts, or other funding mechanisms. Projects proposed under these cooperative agreements and the funding provided must remain distinct and separate from other projects and funding sources. The grantee must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, received through contracts, cooperative agreements, grants, and other funding received by the grantee and these cooperative agreements.

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 and Financial Status Report are required when an award is relinquished, when a recipient changes institutions or when an award is terminated.

An annual Financial Status Report (FSR) (SF-269) must be sent to FDA's grants management officer within 90 days of the budget period end date of each twelve month cooperative agreement. Failure to file the annual FSR in a timely fashion will be grounds for suspension or termination of the cooperative agreement.

For continuing cooperative agreements, mid-year reports and an annual program progress report are also required. For such cooperative agreements, the Non-Competing Continuation Progress Report (PHS-2590) will be considered the program progress report for the fourth quarter of the budget period.

Mid-year progress reports must contain the elements below as applicable to the grantee proposal and award, but are not limited to, the following:

1. Detailed progress report on the grantee meeting the project milestones detailed in the cooperative agreement and identified in the proposal. Goals and objectives should be broken out and reported against.

2. Status report on the hiring and training of any personnel.

3. Status report on the purchasing and operational readiness of any equipment, computers, or software purchased.

4. Summary of improvements (identify and quantify) in the overall food safety program or system resulting from the cooperative agreement.

5. Demonstration of progress, steady improvement, advancement or development of growth of the individual program elements of the MFRPS or SEPs, to include but not limited to self assessment, policies and procedures, and documentation requirements.

6. Identify any pending issues or concerns that may affect accomplishing the objectives and goals of the cooperative agreement. If the objectives and goals of the cooperative agreement are not being met, then a corrective action plan must be submitted. The corrective action plan details the tasks, responsible personnel, and updated timeframes to ensure satisfactory performance and meet the deliverables required under the grant.

7. Detailed program budget demonstrating that grant funds are supplementing, not supplanting, existing non-Federal and other Federal sources of funding at a level equal to the level of such funding in the previous year, increased by the Consumer Price Index.

8. Submission of the following current and fit for use documents in the most current version of the MFRPS:

a. Appendix 1 or alternate form that is equivalent

b. Appendix 2.1 or alternate form that is equivalent

c. Appendix 3.1 or alternate form that is equivalent

d. Worksheets 4.2, 4.3, 4.4, or alternate form that is equivalent

e. Appendix 5.1 or alternate form that is equivalent

f. Appendix 6.1 or alternate form that is equivalent

g. Appendix 7 or alternate form that is equivalent

h. Appendix 8.1 or alternate form that is equivalent

i. Worksheet 9 or alternate form that is equivalent

j. Appendix 10 or alternate form that is equivalent

Annual progress reports must contain the elements below as applicable to their proposal and award, but are not limited to, the following:

1. Detailed progress report on the grantee meeting the project milestones detailed in the cooperative agreement and identified in the proposal. Goals and objectives are broken out and reported against.

2. Status report on the hiring and training of any personnel.

3. Status report on the purchasing and operational readiness of any equipment, computers, or software purchased.

4. Summary of improvements (identify and quantify) in the overall food safety program or system resulting from the cooperative agreement.

5. A strategic plan that accurately reflects when specific objectives and tasks have been, or will be, completed and/or implemented and when new objectives and tasks are identified to achieve or maintain full conformance with the MFRPS and completion of an SEP, if included. Submission of a strategic plan will include the following at the minimum to demonstrate program advancement in achieving conformance with the MFRPS:

a. Specific objectives and tasks that once completed and/or implemented will result in full conformance with the MFRPS.

b. Timelines, responsible personnel, and dedication of any additional resources (such as IT, training, etc.) assigned to each objective and task.

c. Identification of objectives and/or tasks completed during the current project year

d. An assigned MFRPS Project Coordinator with the overall responsibility for implementation of the strategic plan.

Note: For programs with less than 12 months of enrollment in the MFRPS, this information will be required after 12 months of enrollment in the MFRPS.

6. Description of program improvements, demonstration of measurable conformance with the MFRPS, and progress towards implementing SEPs (if pursued). Note: For programs with no previous enrollment in the MFRPS, this information will not be required until Year 2.

7. Detailed progress report on the grantee meeting the project milestones detailed in the cooperative agreement and identified in the proposal.

8. Identify any pending issues or concerns that may affect accomplishing the objectives and goals of the cooperative agreement. If the objectives and goals of the cooperative agreement are not being met, then a corrective action plan must be submitted. The corrective action plan details the tasks, responsible personnel, and updated timeframes to ensure satisfactory performance and meet the deliverables required under the grant.

Additional reporting requirements: For programs with less than 12 months of enrollment in the MFRPS, submission of the baseline self-assessment, including applicable appendices, worksheets, and other documents required for each Standard, or equivalent alternate forms, and a strategic plan are required to be submitted after 12 months of enrollment in the MFRPS. Programs previously enrolled in the MFRPS for a minimum of 12 months, the self-assessment, including applicable appendices, worksheets, and other documents required for each standard or equivalent alternate forms, and current strategic plan should be submitted as appendices with their application. The instructions in the SF-424 Guide must be followed.

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.

The recipient must file a final program progress report, and FSR, within 90 days after the end date of the project period as noted on the notice of the cooperative agreement award.

The final program progress report must provide full written documentation of the project and summaries of accomplishments and goals, as described in the grant application. The documentation must be in a form and contain sufficient detail such that other entities could reproduce the final project.

Monitoring Activities

The program project officer will monitor the recipient periodically. The monitoring may be in the form of telephone conversations, e-mails, or written correspondence between the project officer/grants management officer and the principal investigator. Periodic site visits with officials of the recipient organization may also occur. There may be other regular meetings with recipients to assist in fulfilling the requirements of the cooperative agreement.

The results of these monitoring activities will be recorded in the official cooperative agreement file and will be available to the grant recipient, upon request, consistent with applicable disclosure statutes and FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the cooperative agreement, including those which state that future funding of the project will depend on recommendations from the Project Officer.

The scope of the recommendation will confirm that:

(1) There has been acceptable progress on the project; (2) there is continued compliance with all FDA regulatory requirements, (3) funds are being used to supplement, not supplant, the building of food safety capacity as described in the application; (4) if necessary, there is an indication that corrective action has taken place.

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 HHS grant resources)
Telephone 301-710-0267
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

Wendy Campbell, OP/Contracts and Grants
Project Officer
FDA/ORA/Office of Partnerships
12420 Park Lawn Drive; ELEM-3026
Rockville, MD 20857
Telephone: (615) 310-0483
Email: Wendy.Campbell@fda.hhs.gov

Timothy Weigner, OP/Standards Implementation Staff Director
Technical Advisor
FDA/ORA/Office of Partnerships
12420 Park Lawn Drive; ELEM-3020
Rockville, MD 20857
Telephone: (301) 796-5873
Email: Timothy.Weigner@fda.hhs.gov

Oluyemisi Akinneye
Grants Management Specialist
Food and Drug Administration
Office of Acquisition Support and Grants
Telephone: 301-827-0079
Email: Oluyemisi.Akinneye@fda.hhs.gov

Oluyemisi Akinneye
Grants Management Specialist
Food and Drug Administration
Office of Acquisition Support and Grants
Telephone: 301-827-0079
Email: Oluyemisi.Akinneye@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 Section 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.