E8-13015. Food Protection Task Force Conference

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of conference grant funding for meetings of State Food Protection Task Forces. The original announcement of availability of funding for State Food Safety Task Force Meetings, published in the Federal Register June 25, 2004 (69 FR 35651) and February 4, 2005 (70 FR 6015) as revised on May 3, 2005 (70 FR 22889). This revised announcement provides for a change in the name of the grant program to align with the FDA Food Protection Plan and new policies that apply to the State Food Protection Task Force Meetings conference Grant Program. FDA anticipates providing approximately $160,000 in direct costs only in support of this program in fiscal year (FY) 2008. It is anticipated that 32 awards will be made for up to $5,000 per award.

FOR FURTHER INFORMATION CONTACT:

Regarding the administrative and financial management aspects of this notice: Gladys M. Bohler, Grants Management Specialist at 301-827-7168 or by e-mail at [e-mail]

Regarding the programmatic aspects of this notice: Jennifer Gabb, (DFSR), Office of Regulatory Affairs, FDA at 301-827-2899, e-mail: [e-mail] or access the Internet at: http://www.fda.gov/​ora/​fedlstate/​default.htm.

Announcement Type: New limited competition Request for Applications (RFA) (R13)

Request for Application Number: RFA-FD-08-06

Catalog of Federal Domestic Assistance Number(s): 93.103

Dates: The application receipt date is July 15, 2008.

Paper Applications will not be accepted. Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

The required application, SF 424 (5161) can be completed and submitted online. The package should be labeled, “Response to RFA FD-08-006.” If you experience technical difficulties with your online submission you should contact Gladys M. Bohler by telephone at 301-827-7168 or by e-mail at [e-mail].

Please visit Grants.gov to view the full version of this Request for Applications. A full version of the RFA can also be found on the Grants.gov Web site along with the application package. FDA urges applicants to read the full version RFA in its entirety prior to submitting application packets. A publishing of this announcement in the Federal Register a copy of the full version RFA can also be requested from the ORA and Grants Management contacts listed in the following paragraphs.

Funding Opportunity Description

I. Background

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 in assisting with the previous 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 support include providing effective and efficient compliance of regulated products and, providing high quality, science based work that maximizes consumer protection.

II. Research Objectives

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 section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 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 States that have an existing Food Safety and Food Defense Task Force, as well as to States 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 food protection public health, agriculture, and regulatory agencies.

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

III. Project Goals

The purpose of the Food Protection Task Force meetings is to foster communication and cooperation and collaboration within the States among State local and tribal food protection public health, agriculture and regulatory agencies. (For the purposes of this document and to be consistent with the FDA Food Protection Plan: Food means human food and animal feeds as defined in 21 U.S.C. 321(f). The meetings should: (1) Provide a forum for all the stakeholders of the food protection system—regulatory agencies, academia, industry, consumers, State legislators, Boards of Health and Agriculture and other interested parties; (2) assist in adopting or implementing the Food Code and other food protection regulations; and (3) promote the integration of an efficient statewide food protection/defense system that maximizes the protection of the public health through prevention, intervention and response including the early detection and containment of foodborne illness. Each Task Force shall develop its own guidelines for work, consensus decision making, size and format, at its initial meeting. FDA's Division of Federal State Relations (DFSR) will provide meeting guidelines and organization documents as requested.

Conference grant funds will be awarded only for the direct costs. Each Task Force shall develop its own guidelines for work, consensus decision making, size, and format at its initial meeting. Federal agency representatives may be invited to be nonmember liaisons or advisors to the task force and its meetings. Conference grant funds may not be used for Federal employees to travel to or participate in these meetings.

The following are the allowable and unallowable costs:

Allowable costs include but are not limited to: (1) Salary (in proportion to the time or effort spent directly on the conference/meeting); (2) facility and necessary equipment rental; (3) in-state travel and per diem or subsistence allowances; (4) supplies needed for conduct of the meeting (only if received for use during the budget period); (5) conference services; (6) publication costs; (7) registration fees; and (8) speakers' fees.

Non-allowable costs include but are not limited to: (1) Travel or expenses other than local mileage for local participants; (2) organization dues; (3) travel or per diem costs for Federal employees; (4) purchase of equipment; (5) transportation costs exceeding U.S. carrier coach class fares; (6) visas; (7) passports; (8) entertainment; (9) tips; (10) bar charges; (11) personal telephone calls; (12) laundry charges; (13) honoraria or other payments for the purpose of conferring distinction or communicating respect, esteem or admiration; (14) patient care; (15) alterations or renovations; and (16) facilities and administrative costs/indirect costs.

Please also refer to the DHHS Grants Policy Statement for additional information regarding costs http://www.hhs.gov/​grantsnet/​adminis/​gpd/​index.htm.

IV. Reporting Requirements

A Financial Status Report (FSR) and Mid-Year Progress Reports are required no later than 90 days after the end of a budget period. The Mid-Year Progress Report should contain a description of a specific plan for the next meeting, as well as all criteria listed in the previous paragraph.

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 principal investigator.

When multiple years are awarded, awardees will be required to submit the PHS Non-Competing Grant Progress Report (PHS 2590) annually (http://grants.nih.gov/​grants/​funding/​2590/​2590.htm).

The PHS 2590 must be submitted at least 2 months prior to the next budget period start date and 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 final Progress Report of the meeting(s) (or Conference Proceedings), and FSR SF-269 are required within 90 days of the expiration date of the project period. An original and two copies of each report shall be submitted to FDA's Grants Management staff contact. The report of the meeting should include: (1) The grant number; (2) the title, date and place of time of the meeting; (3) the name of the person shown on the application as the conference director, principal investigator, or program director; (4) the name of the organization that conducted the meeting; (5) a list of individuals and their institutional affiliations who participated as speakers or facilitators in the formally planed sessions of the meeting; and, (6) a summary of topics discussed, next steps and conclusions.

V. Mechanism of Support

A. Award Instrument

This funding opportunity will use the Conference/Scientific Meeting (R13) grant award mechanism. Under the R13 mechanism, the applicant will be solely responsible for planning, directing, and executing the proposed project. Multiple year awards may be awarded to one 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 funding opportunity uses just-in-time budget concepts. It also uses the non-modular budget format. Applicants must complete and submit a detailed categorical budget in the SF424 application.

Meetings covered by this notice will be supported under section 1701-1706 of the Public Service (PHS) Act (42 U.S.C. 300u-300u-5). FDA's Task Force Conference Grant program is described in the Catalog of Federal Domestic Assistance No. 93-103. These 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. The regulations issued under Executive Order 12372 also apply to this program and are implemented through the Department of Health and Human Service's 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.

B. Eligibility

These grants are available to State public health, agriculture and food protection agencies that have an existing Food Safety and Food Defense Task Force, as well as to States 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.

C. Length of Support

It is anticipated that FDA will fund these grants at a level requested but not exceeding $5,000 total direct costs only for the first year. An additional 4 years of support, up to $5,000 (direct costs only) each year may be available, depending upon fiscal year appropriations and successful performance of the conference.

D. Funding Plan

Continued funding for future year, noncompetitive segments, will be contingent upon satisfactory progress as determined annually by the FDA, the receipt of a PHS 2590 application, the approval of yearly task force reports, and the availability of Federal funds. An estimated amount of $160,000 is available in FY 2008. The number of grants funded will depend on the quality of the applications received, their relevance to FDA's mission, priorities, and the availability of funds.

VI. Review Procedure and Criteria

All applications submitted in response to this request for applications (RFA) will first be reviewed for responsiveness by grants management and program staff. Responsiveness is defined as submission of a complete on or before the required submission date as listed in the previous paragraphs. If applications are found to be nonresponsive, they will be returned to the applicant without further consideration.

Responsive applications will be reviewed and evaluated for scientific and technical merit by an ad hoc panel of experts. The following will be considered in making funding decisions: (1) Scientific merit of the proposed conference/scientific meeting as determined by the evaluation process; (2) availability of funds; and (3) relevance of program priorities. Final funding decisions will be made by the Commissioner of Food and Drugs or his or her designee.

Applicants are strongly encouraged to contact FDA Program staff to resolve any questions regarding criteria before the submission of their application.

VII. Submission Requirements

FDA is accepting new applications for this program electronically via www.grants.gov. To download the SF424 (5161) Application forms for this Funding Opportunity Announcement (FOA) link to http://www.grants.gov/​Apply and follow the directions provided on that site. A one-time registration is required for institutions at: Grants.gov (http://www.grants.gov/​GetStarted). The application receipt date is July 15, 2008.

Your organization will need to obtain a Data Universal Number System (DUNS) number as part of the Grants.gov registration process. The DUNS number is a 9-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. The D&B number can be obtained by calling 866-705-5711 or through the Web site at http://www.dnb.com/​us.

The applicant must also register in the Central Contractor Registration (CCR) database in order to be able to submit the application. Information about the CCR is available at http://www.grants.gov/​applicants/​get_​registered.jsp.

VIII. Method of Application

A. Submission Instructions

The SF424 (5161) 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.

B. Format for Application

A completed application in response to this FOA includes the data in the following components:

The face page of the application should indicate “Response to Food Protection Task Force Conference Grant Program RFA FD 08-006”.

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.

IX. Freedom of Information

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

Dated: June 3, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.