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Part I Overview Information

Department of Health and Human Services

Participating Organizations
Food and Drug Administration (FDA) http://www.fda.gov

Components of Participating Organizations
Office of Regulatory Affairs http://web.ora.fda.gov/dfsr

Title: Food Protection Task Force Conference (R13)

Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of RFA-FD-08-006.

Update: The following update relating to this announcement has been issued:

Program Announcement (PA) Number: PAR-09-123

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)

93.103

Key Dates
Release/Posted Date:March 19, 2009
Opening Date: March 19, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): N/A
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): May 11, 2009, February 24, 2010, February 24, 2011, (New Date March 30, 2012 per NOT-FD-12-002), Original Date February 23, 2012
AIDS Application Due Date(s): N/A
Peer Review Date(s): June, 2009, April, 2010, April, 2011, April, 2012
Council Review Date(s): Not Applicable
Earliest Anticipated Start Date(s): July, 2009, May, 2010, May, 2011, May, 2012
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration Date: (Extended to March 31, 2012 per NOT-FD-12-002), Original Date February 24, 2012

Due Dates for E.O. 12372

Single Point of Contact program under E.O. 12372 is applicable for FDA.

http://www.whitehouse.gov/omb/grants/spoc.html

Additional Overview Content

Executive Summary

This revised announcement provides for the change in the name of the grant program to be consistent with the FDA Food Protection Plan and new policies that apply to the State Food Protection Task Force Meetings conference Grant Program.

FDA views State-based Food Protection Task Forces as an important mechanism for providing food safety and food defense program coordination, and information exchange within each State. ("Food" includes human food and animal feed and is defined in 21 USC 321(f)). This grant announcement is intended to encourage the development of a Task Force within each State and to provide funding for Task Force meetings. Conference grant funding is available to State, local, and tribal agencies that have an existing Food Safety and Food Defense Task Force, as well as to States agencies that are in the process of developing a new Food Protection Task Force. State Food Protection Task Force meetings should foster communication and cooperation among State, local, and tribal public health and food safety agencies and other interested parties.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1.ResearchObjectives

The FDA’s Office of Regulatory Affairs (ORA) is the inspection component of the FDA and has 1,000 investigators and inspectors who cover the approximately 95,000 FDA regulated businesses in the United States and inspect more than 15,000 facilities a year. In addition to the standard inspection program, FDA’s investigators and inspectors conduct special investigations, food inspection recall audits, and perform consumer complaint inspections and sample collections.

In the past FDA has relied on the States to assist with the above duties through formal contracts, partnership agreements, and other informal arrangements. The inspection demands on both the Agency and the States are expected to increase. Accordingly, procedures need to be reviewed and innovative changes made that will increase effectiveness, efficiency, and conserve resources. Examples of collaboration include helping to ensure effective and efficient compliance with State and Federal standards of regulated products and providing high-quality, science-based work that maximizes consumer protection.

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. Foodborne disease causes an estimated 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths in the United States each year, and an estimated $6.9 billion in economic costs. New challenges continue to arise, including the globalization of the food supply and the emergence of new pathogens in foods.

These facts reinforce the importance of this State Food Protection Task Force program. Task Forces should consider the plans and activities listed below as a part of their goal for planning meetings and activities:

(1) FDA is responsible for the safety of the vast range of food Americans eat; about 80 percent of all food sold in the United States. This includes everything except for meat, poultry, and processed egg products, which are regulated by the U.S. Department of Agriculture (USDA).

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.

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

  1. The prevention element means promoting increased corporate responsibility so that food problems do not occur in the first place. By comprehensively reviewing food supply vulnerabilities and developing and implementing risk reduction measures with industry and other stakeholders, we can best address critical weaknesses.
  1. The intervention element focuses on risk-based inspections, sampling, and surveillance at high risk points in the food supply chain. These interventions must verify that the preventive measures are in fact being implemented, and done so correctly.
  1. The response element bolsters FDA's emergency response efforts by allowing for increased speed and efficiency. It also includes better communication with other Federal, State, and local government agencies and industry during and after emergencies. Whether contamination is unintentional or deliberate, there is a need to respond quickly and to communicate clearly with consumers and other stakeholders. The communication should emphasize identifying products of concern as well as informing the public of what is safe to consume.

(3) The focus of these grant sponsored meetings should be to discuss and resolve issues at the State and local levels relating to the following areas:

A. State/local agency roles and responsibilities: (1) capacity and resource needs; (2) outbreak coordination and investigations; (3) information sharing and data collection; (4) uniform regulatory standards; (5) communications and education; (6) State/local laboratory operations and coordination; (7) adoption and implementation of the FDA Food Code and other food protection regulations; (8) uniform standards for foodborne illness and outbreak reporting investigation and response; (9) State and local training needs; and (10) food defense activities and coordination.

1. Food Defense Activities:

The following should be considered by the task forces in planning and group facilitation of meetings within their respective states:

Target (hard-to-reach) stakeholders focusing on specialized ethnic and small to moderate (medium) sized establishments.

Integrate food safety and food defense among public health, food, and agriculture sectors and stakeholders for a cohesive food protection integration.

Establish best practices for collaboration and alignment of resources among public and private sectors.

Prevention Activities:

Awareness/Outreach to include the FDA messages related to food defense awareness, ALERT, and FIRST.

Vulnerability/Risk Assessments to include the extension and training related to the CARVER + Shock vulnerability assessment tool and its use within food facilities.

Criticality/Key Resources promotion and use of the Department of Homeland Security State Guidance tool (FASCAT) to identify and prioritize critical infrastructure and key resources within their State borders and possible regional-to-national effects.

Food Code/Regulatory Measures Roles/Responsibilities to include local, state, regional and national issues in prevention and preparedness for both natural and man-made disasters.

Training/Education to include the FDA messages related to food protection, ALERT, and FIRST.

Intervention Activities:

GAPs/Needs Assessment related to what resources will be needed to assist in recovering from an event based on what is needed on the local level, the state level, and the regional/national level.

Reporting/Follow-Up best practices recommendations for reporting structures and needed follow-up activities (as well as roles and responsibilities) after an event has occurred to return to a steady-state as it was prior to an event.

Response Activities:

Communication evaluate communication processes and identify gaps within regulatory agencies and industry, and also coordination of public messages.

Recalls including development of improved procedures to communicate significant public health recall information to a broader audience within the state.

Traceability to evaluate the need for improved processes for tracing food through the distribution chain efficiently and rapidly to minimize consumer exposure.

Reporting initiate improved information sharing and reporting mechanisms within States and among/between States and federal agencies.

2. Food borne Illness Activities:

Develop processes that will facilitate the investigation, prevention, and control of foodborne disease outbreaks, e.g., guidelines for responding to multi-jurisdictional outbreaks, and guidelines for sharing results between and among key stakeholders including Federal, State, and local governmental agencies, industry, and consumers. Establish a risk-based profile of foods implicated in foodborne outbreaks and monitor the trends of implicated foods. Identify and monitor contributing factors and their environmental antecedents, establish the chemical/biologic agent responsible for foodborne outbreaks.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This FOA will use the FDA Scientific Conference /Meeting (R13) grant award mechanism. Under this R13 grant mechanism, the Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project. Multiple year awards may be made to a permanently sponsoring organization for conferences held annually or biennially on a recurring topic. The total project period for an application requesting support may not exceed 5 years.

This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Applicants must complete and submit a detailed categorical budget using the Research & Related Budget Component.

2.FundsAvailable

Because the nature and scope of the proposed activities will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the number of applications, quality, duration, and costs of the applications received and the availability of funds.

Facilities and Administrative (F&A) costs are not allowed under this program.

Multiple year awards may be made for conferences held annually or biennially on a recurring topic. The total project period for an application requesting support may not exceed five years.

Under this announcement, the FDA anticipates providing approximately $160,000 in direct costs in support of this program in Fiscal Year 2009. It is estimated that about 32 grants, each at the level requested but not exceeding $5,000 total (direct costs only) for the first year, will be awarded. An additional 4 years of support of up to approximately $5,000 (direct costs only) each year will be available, depending upon fiscal year appropriations and successful performance.

A decrease in the amount of the non-competitive segment may occur if there is an unobligated balance from the prior year, in which case prior year funds can be used as an offset for the current year award.

Continued funding of a noncompetitive segment is contingent upon satisfactory progress as determined annually by FDA procedures, the receipt of a non-competing continuation application, submission of a satisfactory final yearly Task Force report, and the availability of Federal funds.

FDA grants policies as described in the DHHS Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

This grant program is only available to State, Local, and tribal government agencies, which include State public health, agriculture, and food protection agencies. Grants are available to State agencies that have an existing Food Safety and Food Defense Task Force, as well as those that are in the process of developing a new Food Protection Task Force. Only one grant will be awarded per State per year. States are urged to collaborate between agencies to submit a single application.

Grantees with active grant applications under the Food Protection Task Force Program are not eligible to apply under this FOA.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the 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.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current DHHS Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

3. Other-Special Eligibility Criteria

Resubmissions: Applicants are not permitted to submit a resubmission application in response to this FOA.

Renewals. Renewal applications will be permitted for this FOA.

Number of Applications. Applicants may submit more than one application, provided each application is programmatically distinct.

Prior to submission of an application, the State shall designate one State public health or food safety agency to lead, coordinate, and host the Food Protection Task Force and its meetings. The formation of Food Protection Task Forces and meetings shall not interfere with existing Federal-State advisory mechanisms or state-required committees or advisory groups. Responsiveness is defined as submission of a complete application on or before the required submission date as listed above. Applications found to be non-responsive will be returned to the applicant without further consideration.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

o Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact Grants Info -- Telephone 301-710-0267; Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to FDA. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by FDA (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
Research & Related Subaward Budget Attachment(s) Form
PHS398 Checklist (See Section IV.6., Special Instructions, regarding appropriate required budget component.)

SPECIAL INSTRUCTIONS

The face page of the application should indicate Response to Food Protection Task Force Conference Grant Program PA-09-123 .

Applications should include the following: (1) A title which has the term State Food Protection Task Force Meetings , conference , council , workshop , alliance or other similar description to assist in the identification of the request; (2) location of the conference; (3) expected number of registrants and type of audience expected with their credentials; (4) dates of conference(s); (5) conference format and projected agenda(s), including list of principal areas or topics to be addressed; (6) physical facilities required for the conduct of the meeting; (7) justification of the conference(s), including the problems it intends to clarify and any developments it may stimulate; (8) brief biographical sketches of individuals responsible for planning the conference(s) and details concerning adequate support staff; (9) information about all related conferences held on this subject during the last 3 years (if available); (10) details of proposed per diem/subsistence rates, transportation, printing, supplies and facility rental costs; and (11) the necessary checklist and assurances pages provided in each application package.

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are required when using the Non-Modular budget format.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: March 19, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): N/A
Application Due Date(s): May 11, 2009, February 24, 2010, February 24, 2011, February 23, 2012
AIDS Application Due Date(s): N/A
Peer Review Date(s): June, 2009, April, 2010, April, 2011, April, 2012
Council Review Date(s): Not Applicable
Earliest Anticipated Start Date(s): July, 2009, May, 2010, May, 2011, May, 2012

3.A.1. Letter of Intent

A letter of intent is not required for this funding opportunity.

3.B. Submitting an Application Electronically to the FDA

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

In order to expedite the review, applicants are requested to notify the FDA Grants Management Team by email (gladys.melendez-bohler@fda.hhs.gov) when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

3.C.ApplicationProcessing

Do not send applications to the Center for Scientific Research (CSR), NIH. Any application sent to NIH that is then forwarded to FDA and not received in time for orderly processing will be deemed unresponsive and returned to the applicant.

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.

Upon receipt, applications will be evaluated for completeness and responsiveness by the FDA. Incomplete and non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

The FDA will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The FDA will not accept any application that is essentially the same as one already reviewed. However, the FDA will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

4. Intergovernmental Review

This initiative is subject to intergovernmental review

Intergovernmental review applicants are limited to one State government agency per State. Applications submitted under this program are subject to the requirements of Executive Order (E.O.) 12372.

The regulations issued under EO 12372 also apply to this program and are implemented through the DHHS regulations at 45 CFR part 100. Executive Order 12372 sets up a system for State and local government review of applications for Federal financial assistance. Applicants (other than federally recognized Indian tribal governments) should contact the State’s Single Point of Contact (SPOC) as early as possible to alert them to the prospective application(s) and to receive any necessary instructions on the State’s review process. The SPOC should send any State review process recommendations to the FDA Grants Management Team as listed under contacts below. The due date for the State process recommendations is no later than 60 days after the deadline date for the receipt of applications. The FDA does not guarantee availability to accommodate or explain SPOC comments that are received after the 60 day cut-off. A current listing of SPOCs can be found at www.whitehouse.gov/omb/grants/spoc.html

5. Funding Restrictions

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the DHHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

6. Other Submission Requirements and Information

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time on the application submission/receipt date(s). If an application is not submitted by the receipt date(s) and time, the application will not be reviewed.

Upon receipt, applications will be evaluated for completeness and incomplete applications will not be processed or evaluated.

Applicants are reminded that failure to include all required documents as part of the application may result in an application being considered as incomplete or non-responsive.

Prior to submission of an application, the State shall designate one State public health or food safety agency to lead, coordinate, and host the Food Protection Task Force and its meetings. The formation of Food Protection Task Forces and meetings shall not interfere with existing Federal-State advisory mechanisms or state required committees or advisory groups.

Applicants are strongly encouraged to contact FDA to resolve any questions regarding criteria prior to submission of their application. All questions of a technical or programmatic nature must be submitted to the FDA program staff. All questions of an administrative or financial nature must be submitted to the Grants Management Staff.

A copy of the complete FOA can also be viewed on the Grants.gov website along with the funding opportunity application package. A copy of the full FOA can be obtained from the Program or Grants Management contact listed under Contacts in this FOA once the FOA is published.

The following instructions are to be used in conjunction with application packet instructions:

Performance Site Locations: Enter the site of the conference or meeting as the Performance Site.

Senior/Key Person: Personnel are defined as the Project Director (PD)/Principal Investigator (PI) and those responsible for the scientific planning and organization of the meeting. Attach a biographical sketch for PD/PI, Co-Chair, key personnel, and confirmed key speakers.

Budget Information: Enter the direct costs requested. Provide a narrative budget justification for each proposed personnel position, including role and proposed level of effort and for each item of cost requested. Include information regarding attempts efforts to obtain funding for this conference/meeting from other funding sources.

Allowable Costs: Conference grant funds will be awarded only for direct costs incurred to secure meeting facility rental expenses, supplies, publication costs, and in-State travel expenses for meeting attendees. Federal agency representatives may be invited to be non-member liaisons or advisors at the meetings. Conference Grant funds may not be used to support federal employee(s) attendance of the meetings. Allowable costs consist of: (1) salaries in proportion to the time or effort spent directly on the conference; (2) rental of necessary equipment; (3) travel and per diem; (4) supplies needed to conduct the meeting; (5) conference services; (6) publication costs; (7) registration fees (excluding cost of meals); and (8) speaker’s fees.

Non-allowable costs: Include but not limited to: Travel or expenses other than local mileage for local participants; organization dues; travel or per diem costs for federal employees. Purchase of equipment; transportation costs exceeding U.S. carrier coach class fares; visas; passports; entertainment; tips; bar charges; personal telephone calls; laundry charges; dues; honoraria or other payments for the purpose of conferring distinction or communicating respect, esteem or admiration; patient care; alterations or renovations; facilities and administrative costs/indirect costs. Please also refer to the DHHS Grants Policy Statement for additional information regarding costs.

Conference Plan: Submit one attachment, which may not exceed 10 pages. In the Conference Plan (uploaded as attachment #5) section of the application, describe the objectives, specific program, and logistical arrangements for the meeting. Describe the format and agenda, including the principal topics to be covered, problems to be addressed, and developments or contributions the meeting might stimulate. Provide a detailed justification for the meeting, including the scientific need, timeliness, and usefulness of the meeting to the scientific community. Describe the composition and role of the organizing committee, and provide the names and credentials of key participants in the meeting, including the basis for their selection and documentation of their agreement to participate.

Describe plans for the appropriate involvement of women, minorities, and persons with disabilities in the planning and implementation of the proposed meeting. Estimate the expected size and composition of the audience, as well as the method of selection. Describe plans for publicizing the meeting and publication of the proceedings. Identify related meetings held on the subject during the past three years.

Applications requesting multiple years of support must provide the following additional information for each future year requested, in as much detail as possible: meeting topic(s); tentative dates, locations, and participants; and contingency plans for future meetings dependent upon, for example, the outcome of the first year’s meeting or developments in the field.

PD/PI Credential (e.g., Agency Login)

The FDA requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS398 Research Plan Component Sections:

Submit one attachment, which may not exceed 10 pages, under the Research Design and Methods section (line Item 5). While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to FDA in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used. Letters of agreement to participate from key speakers and participants should be attached at line item 16. Do not complete Sections 2-4 and the Human Subjects Sections (6-10) of the PHS 398 Research Plan.

In the Conference Plan section of the application (uploaded as attachment #5), describe the objectives, specific program, and logistical arrangements for the meeting. Describe the format and list the agenda and speakers, including the principal topics to be covered, problems to be addressed, and developments or contributions the conference/meeting might stimulate. Provide a detailed justification for the conference/meeting, including the public health need, timeliness, and usefulness of the conference/meeting to the scientific community. Describe the composition and role of the organizing committee, and provide the names and credentials of key participants in the conference /meeting, including the basis for their selection and documentation of their agreement to participate.

Describe plans for the appropriate involvement of women, minorities, and persons with disabilities in the planning and implementation of, and participation in, the proposed conference/meeting. Estimate the expected size and composition of the audience, as well as the method of selection. Describe plans for publicizing the conference/meeting to all interested participants and for publishing the proceedings (with the latter possibility not being required). Identify related conferences/meetings held on the subject during the past 3 years (and how the proposed conference/meeting is similar to, and/or different from these, and why it is still necessary and useful). If this is one of a series of periodic conferences/meetings held by a permanent sponsoring organization, briefly describe and evaluate the last conference/meeting in the series.

Applications requesting multiple years of support must provide the following additional information for each future year requested, in as much detail as possible: Meeting topics; tentative dates, locations, participants, and contingency plans for future meetings dependent upon, for example, the outcome of the first year’s conference/meeting or developments in the field.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not comply with the required page limitations may be delayed in the review process.

Resource Sharing Plans(s)

The following resource sharing policies do not apply to this FOA:

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the ORA/DFSR and in accordance with FDA peer review procedures using the review criteria stated below.

As part of the scientific peer review, all applications will:

Applications submitted in response to this FOA 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:

The goals of FDA supported research are to protect the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and for helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Applications will be given an overall score and judged based on all of the following criteria: (1) The content/subject matter and how current and appropriate it is for the mission of FDA; (2) the conference plan and how thorough, reasonable, and appropriate it is for the intended audience; (3) the experience, training, and competence of the principal investigator/director and availability of support staff; (4) the adequacy of the facilities; and (5) the reasonableness of the proposed budget given the total conference plan, program, speakers, travel, and facilities.

Significance: Does this conference address an important problem? If the aims of the application are achieved, how will food safety knowledge be advanced? What will be the effect of this conference on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual framework, design, and topics adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

Innovation: Is the conference topic original and innovative? For example: Does the conference address an innovative hypothesis or critical barrier to progress in the field? Does the conference develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Principal Investigators/Project Directors: Are the PD(s)/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other staff? Do (es) the PD(s)/PI(s) and respective team bring complementary and integrated expertise to the conference (if applicable)?

Environment: Do (es) the conference facility (ies) in which the meeting will take place contribute to the probability of success? Do the proposed topics benefit from unique features of the stakeholder environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

FDA affirms that the value of scientific meetings is enhanced by including participants from all segments of the scientific population and, when appropriate, members of the lay community, in both the planning and conduct of such meetings. The adequacy of plans to include women, minorities and persons with disabilities in the planning and execution of a scientific meeting or conference is important to its success and relevance and will be assessed. For guidance refer to the DHHS Grants Policy Statement (http://www.hhs.gov/grantsnet/adminis/gpd/index.htm) and/or the NIH policy on the Inclusion of Women, Minorities and Persons with Disabilities in NIH Supported Conference Grants: (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-066.html)

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the requested period of support in relation to the proposed plan will be considered. Does the amount requested from FDA appear reasonable as partial support of the total conference given the plan, facilities, travel, and speakers? The priority score will [?] not be affected by the evaluation of the budget.

Previous Experience: Is there previous experience with the organization/or the principal investigator in similar undertakings? If so, what?

Review and Selection Process: All applications submitted in response to this FOA will first be reviewed for responsiveness by grants management and program staff.

Responsive applications will be reviewed and evaluated for scientific and technical merit by an ad hoc panel of experts. Final funding decisions will be made by the Commissioner of Food and Drugs or his or her designee.

2.C. Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

3. Anticipated Announcement and Award Dates

The successful applicants will receive notice of pending award about two weeks after review of applications through the Grants Management contact.

Section VI. Award Administration Information

1. Award Notices

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

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as referenced in the DHHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the Grants Management Officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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.

2. Administrative and National Policy Requirements

All FDA grant and cooperative agreement awards include the DHHS Grants Policy Statement as part of the NoA. For these terms of award, see the http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

The grants will be subject to all policies and requirements that govern the Conference Grant Programs of the PHS, including the provisions of 42 CFR Part 52 and 45 CFR Parts 74 and 92. Meetings covered by this notice will be supported under section 1701-1706 (42 U.S.C. 300u-300u-5) of the Public Service Health Act. FDA’s Conference Grant Program is described in the Catalog of Federal Domestic Assistance, No. 93.103.

The following Term and Condition will be incorporated into the award statement and will be provided to the PDPI(s) as well as to the appropriate institutional official, at the time of award.

All conference material (promotional materials, agenda, publications and internet sites) related to this project must include an acknowledgement of FDA grant support and a disclaimer stating the following: Funding for this conference was made possible [in part] by [insert grant number] from [insert FDA name]. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.

3. Reporting

Awardees have primary authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of the conference.

An agency Program Official or Center Program Director/Project Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the NoA.

A final Progress Report of the meeting(s) or Conference Proceedings and a final Financial Status Report (FSR) (SF-269) are required within 90 days of the expiration date of the project period as noted on the Notice of Grant Award. An original and one copy of each report shall be submitted to FDA’s Grants Management Specialist listed in the NoA. The report of the meeting should include: (a) the grant number; (b) the title, date and place of time of the meeting; (c) the name of the person shown on the application as the conference director, principal investigator, or program director; (d) the name of the organization that conducted the meeting; (e) a list of individuals and their institutional affiliations who participated as speakers or facilitators in the formally planed sessions of the meeting; and, (f) a summary of topics discussed, next steps and conclusions.

Program monitoring of recipients will be conducted on an ongoing basis and written reports will be reviewed and evaluated at least semi-annually by the project officer. Project monitoring may also be in the form of telephone conversations between the project officer/grants management specialist and the project director/principal investigator.

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the DHHS Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

Reports must be submitted two months prior to the next budget period start date. The Progress Report should include a report of the previous meeting supported by the current grant, as well as a full description of the next planned meeting.

A Request for a Non-Competing Continuation Grant Progress Report (PHS 2590) with specific reporting instructions will be sent to Grantees two to three months prior to the start of the next budget period by the ORA/Project Officer.

A Financial Status Report (FSR) is required no later than 90 days after the end of each budget period. A final progress report, invention statement, and Financial Status Report are required when an award is relinquished, when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:

1. Programmatic Contact(s):

Jennifer Gabb
FDA/ ORA
Division of Federal Relations
5600 Fishers Lane, Rm. 12-07
Rockville, MD 20857
Telephone: (301) 827-2899
Email: Jennifer.gabb@fda.hhs.gov

2. Peer Review Contact(s):

Jennifer Gabb
FDA/ ORA
Division of Federal Relations
5600 Fishers Lane, Rm. 12-07
Rockville, MD 20857
Telephone: (301) 827-2899
Email: Jennifer.gabb@fda.hhs.gov

3. Financial/Grants Management Contact(s):

Gladys M. Bohler
Division of Acquisition Support and Grants
5630 Fishers Lane, Rm. 2105
Rockville, MD 20857
Telephone: (301) 827-7168
Fax: 301-827-7101
Email: gladys.melendez-bohler@fda.hhs.gov

Section VIII. Other Information

Required Federal Citations

URLs in FDA Grant Applications or Appendices:

All applications and proposals for FDA funding must be self-contained within specified page limitations. Unless otherwise specified in an FDA solicitation, internet addresses (URLs) should not be used to provide information necessary for the review because reviewers are under no obligation to view the Internet sites.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
Meetings covered by this notice will be supported under section 1701-1706 (42 U.S.C. 300u-300u-5) of the Public Service Health Act and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the DHHS Grants Policy Statement. The DHHS Grants Policy Statement can be found at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.

This program is described in the Catalog of Federal Domestic Assistance (CFDA 93.103) at http://www.cfda.gov/ and is subject to the intergovernmental review requirements of Executive Order 12372.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Freedom of Information: Data included in the application which have been specifically identified by the applicant as containing restricted and/or proprietary (confidential) information may be entitled to confidential treatment as trade secret or confidential commercial information within the meaning of the Freedom of Information Act (FOIA) (5 U.S.C. 552(b)(4)) and FDA's implementing regulations (21 CFR 20.61).

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