Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is issuing a revised request for application (RFA) that will replace the announcements published June 25, 2004 (69 FR 35651) and February 4, 2005 (70 FR 6015). FDA, in collaboration with the Centers for Disease Control and Prevention (CDC), is announcing the availability of conference grant funding for meetings of State Food Safety and Food Security Task Forces. The original announcement of availability of funding for State Food Safety Task Force Meetings, published in the Federal Register on January 24, 2000 (65 FR 3720), is superseded by this announcement. This revised announcement provides new policies that apply to the State Food Safety and Food Security Task Force Meetings Conference Grant Program. The FDA views this program as an ongoing program announcement, contingent on the availability of funds.
The application receipt date is July 5, 2005.
Applicants are strongly encouraged to apply electronically by visiting the Web site at http://www.grants.gov and following instructions under “APPLY.” Applications also are available from, and completed applications may be submitted to, Michelle Caraffa, Division of Contracts and Grants Management (HFA-500), Food and Drug Administration, 5600 Fishers Lane, rm. 2129, Rockville, MD 20857, 301-827-7025, e-mail: firstname.lastname@example.org. Application forms PHS 5161-1 are available via the internet at: http://www.psc.gov/forms (Revised 7/00). Applications hand carried or commercially delivered should be addressed to 5630 Fishers Lane (HFA-500), rm. 2129, Rockville, MD 20857.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Regarding the administrative and financial management aspects of this notice: Michelle N. Caraffa (see ADDRESSES).
Regarding the programmatic issues of this notice: Stephen Toigo, Division of Federal-State Relations (DFSR), Office of Regulatory Affairs (ORA), Food and Drug Administration (HFA-150), 5600 Fishers Lane, rm. 12-07, Rockville, MD 20857, 301-827-2906, E-mail: email@example.com, or access the Internet at http://www.fda.gov/ora/fed_state/default.htm.
For general ORA program information: Contact your Regional Food Specialists at http://www.fda.gov/ora/fed_state/DFSR_Activities/food specialists.htm.End Further Info End Preamble Start Supplemental Information
The purpose of the Food Safety and Food Security Task Force meetings is to foster communication and cooperation within the States among State and local food safety regulatory agencies. The meetings should: (1) Provide a forum for all the stakeholders of the food safety system—regulatory agencies, academia, industry, consumers, State legislators, and other interested parties; (2) assist in adopting or implementing the Food Code; and (3) promote the integration of an efficient statewide food safety system that maximizes the protection of the public health through 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 DFSR will provide meeting guidelines and organization documents as requested.
I. Funding Opportunity Description
FDA is issuing a revised RFA which will replace the announcements published June 25, 2004 (69 FR 35651) and February 4, 2005 (70 FR 6015). FDA, in collaboration with the CDC, is announcing the availability of conference grant funding for meetings of State Food Safety and Food Security Task Forces. The original announcement of availability of funding for State Food Safety Task Force Meetings, published in the Federal Register on January 24, 2000, is superseded by this announcement. This revised announcement provides new policies that apply to the State Food Safety and Food Security Task Force Meetings Conference Grant Program. The FDA views this program as an ongoing program announcement, contingent on the availability of funds.
FDA and CDC view State based Food Safety and Food Security Task Forces as important mechanisms for promoting food safety, food security program coordination, and information Start Printed Page 22890exchanges within each State. 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 Security Task Force, as well as to States that are in the process of developing such a Task Force. State Food Safety Task Force meetings should foster communication and cooperation among State and local public health and food safety agencies and other interested parties.
Meetings covered by this notice will be supported under sections 1701-1706 (42 USC 300u-300u-5) of the Public Health Service Act.
Conference grant funds will be awarded only for the direct costs incurred to secure meeting facility rental expenses, supplies, publication costs, and in-state travel expenses for meeting attendees. Each Task Force shall develop its own guidelines for work, consensus decisionmaking, size and format, at its initial meeting. Federal agency representatives may be invited to be nonmember liaisons or advisors at the meetings. Conference grant funds may not be used for Federal employees to travel to these meetings.
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 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 support include providing effective and efficient compliance of regulated products and providing high quality, science based work that maximizes consumer protection.
CDC is a nonregulatory Federal public health agency that works closely with FDA food safety regulatory and other agencies to prevent foodborne disease. CDC leads Federal efforts to gather data on foodborne illnesses, investigates foodborne illnesses and outbreaks, and monitors the effectiveness of prevention and control efforts. CDC also plays an ongoing role in identifying prevention strategies and building State and local health department epidemiology, laboratory, and environmental health capacity to support foodborne disease surveillance and outbreak response. CDC data assists in documenting whether food safety interventions are leading to reductions in the incidence of foodborne illness.
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 Safety and Security Task Force program. 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: (1) State/local Agency roles and responsibilities; (2) capacity and resource needs; (3) outbreak coordination and investigations; (4) information sharing and data collection; (5) uniform regulatory standards; (6) communications and education; (7) State/local laboratory operations and coordination; (8) adoption/implementation of the FDA Food Code; (9) uniform standards for foodborne illness and outbreak reporting investigation and response; and (10) State and local training needs for epidemiology, outbreak investigation, etc.
B. Project Goals, Definitions, and Examples
The purpose of the Food Safety and Food Security Task Force meetings is to foster communication and cooperation within the States among State and local food safety regulatory agencies. The meetings should: (1) Provide a forum for all the stakeholders of the food safety system—regulatory agencies, academia, industry, consumers, State legislators, and other interested parties; (2) assist in adopting or implementing the Food Code; and (3) promote the integration of an efficient statewide food safety system that maximizes the protection of the public health through early detection and containment of foodborne illness. Each Task Force shall develop its own guidelines for work, consensus decisionmaking, size and format, at its initial meeting.
FDA DFSR will provide meeting guidelines and organization documents as requested.
II. Award Information
The FDA anticipates providing approximately $350,000 in direct costs only in support of this program in Fiscal Year (FY) 2005. It is anticipated that 50 awards will be made for up to $7,000 per award. Under this grant announcement, States may be awarded grants for up to 3 years for a maximum of $7,000 per year in direct costs only, contingent on the availability of funds. FDA will consider funding meetings for up to 3 years. Funding after the first year will be at an amount that will be negotiated at the time of the initial competitive segment. Thus, the budgets for all 3 years of requested support must be fully justified in the original application.
Continued funding of a noncompetitive segment is contingent upon satisfactory progress as determined annually by FDA procedures, the receipt of a noncompeting continuation application, and availability of Federal funds. The noncompeting continuation will consist of an SF424 Face Page, a financial status report, and conference proceedings for all conferences held the previous budget period. A decrease in the amount of the noncompetitive 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.
A. Award Instrument
Support for this program will be in the form of a grant.
B. Length of Support
It is anticipated that FDA will fund these grants at a level requested but not exceeding $7,000 total (direct costs only) for the first year. An additional 2 years of support up to approximately $7,000 (direct costs only) each year will be available, depending upon fiscal year appropriations, and successful performance.
C. Funding Plan
Federal funds are currently available from FDA for this program. However, awards are subject to the condition that, in addition to FDA funds, augmenting funds are transferred to FDA from CDC to fully support this program. As the lead Federal agency, FDA intends to collect funds from CDC through an Interagency Agreement. An estimated Start Printed Page 22891amount of $100,000 is available in FY2004 through the Interagency Agreement for a total of $350,000. The number of grants funded will depend on the quality of the applications received, their relevance to the FDA mission, priorities, and the availability of funds.
III. Eligibility Information
1. Eligible Applications
These grants are available to State public health and food safety agencies. Only one grant will be awarded per State per year.
2. Cost Sharing or Matching
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 Safety and Food Security Task Force and its meetings. The formation of Food Safety and Food Security Task Force meetings shall not interfere with existing Federal-State advisory mechanisms. Responsiveness is defined as submission of a complete application with original signatures on or before the required submission date as listed above. If applications are found to be non-responsive, they will be returned to the applicant without further consideration.
IV. Application and Submission Information
1. Address to Request Application Package
FDA is accepting new applications for this program electronically via Grants.gov. Applications are strongly encouraged to apply electronically by visiting the website http://www.grants.gov and following instructions under “APPLY.” The applicant must 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/CCRRegister. The applicant must register with the Credential Provider for Grants.gov. Information about this requirement is available at http://www.grants.gov/CredentialProvider.
Applications also are available from, and completed applications should be submitted to, Michelle Caraffa, Division of Contracts and Grants Management (HFA-500), Food and Drug Administration, 5600 Fishers Lane, rm. 2129, Rockville, MD 20857, 301-827-7025, e-mail: firstname.lastname@example.org. Applications forms PHS 5161-1 are available via the internet at: http:www.psc.gov/forms (Revised 7/00). Applications hand carried or commercially delivered should be addressed to 5630 Fishers Lane (HFA-500), rm. 2129, Rockville, MD 20857. An application not received in time for orderly processing will be returned to the applicant without consideration.
2. Content and Form of Application Submission
If not submitting electronically, the original and two copies of the completed grant application Form PHS-5161-1 (Revised 07/00) for State and local governments should be delivered to the Grants Management Office (address above).
As indicated in section IV.1, FDA is accepting new applications for this program electronically. Please go to Grants. Gov “apply” for the application package.
When using Form PHS 5161-1 (Rev 07/00), all instructions for the enclosed Standard Form 424 (SF424) should be followed using the nonconstruction application pages.
The face page of the application should indicate “Response to Food Safety Task Force Conference Grant Program.” The outside of the mailing package should also be labeled “Response to Food Safety Task Force Conference Grant Program.” Submit applications on Form 424 (SF424) and include the following: (1) A title which has the term “state food safety 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 known); (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.
A properly formatted sample application for grants can be accessed on the Internet at: http://www.fda.gov/ora/fed_state/Innovative_Grants.html.
Data included in the application, if restricted with the legend specified below, 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).
Information collection requirements requested on PHS Form 5161-1 were approved and issued under Office of Management and Budget (OMB) Circular A-102.
As of October 1, 2003, applicants are now required to have a DUNS number to apply for a grant or cooperative agreement from the Federal government. 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. To obtain a DUNS number, call 1-866-705-5711. Identify yourself as a Federal grant applicant when you contact Dun and Bradstreet.
3. Submission Dates and Times
The first application receipt date for FY 2005 is March 15, 2005, and the final application date for FY 2005 is July 5, 2005 and March 15 for each subsequent year this program is in effect. No supplemental material or addenda will be accepted after the receipt date.
Applications will be accepted during working hours, 8 a.m. to 4:30 p.m., Monday through Friday, on or before the established receipt date. Applications will be considered received on time if sent or mailed on or before the receipt date as evidenced by a legible U.S. Postal Service dated postmark or a legible date receipt from a commercial carrier, unless they arrive too late for orderly processing. Private metered postmarks shall not be acceptable as proof of timely mailing. Applications not received on time will not be considered for review and will be returned to the applicant. Applicants should note that the U.S. Postal Service does not uniformly provide dated postmarks. Before relying on this method, applicants should check with their local post office.
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. The outside of the mailing package and item 2 of the application face page should be labeled “Response to Food Safety Task Force Conference Grant Program.” You must Start Printed Page 22892submit only one application, an original and two copies, per package.
4. 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 E.O. 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. A current listing of SPOCs is included in the application kit. The SPOC should send any State review process recommendations to the FDA Grants Management Office address listed above. 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
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 for Federal employees to travel to these 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; and (8) speaker's fees.
Nonallowable costs include, but are not limited to: (1) Purchase of equipment; (2) transportation costs exceeding coach class fares; (3) entertainment; (4) tips; (5) bar charges; (6) personal telephone calls; (7) laundry charges; (8) travel or expenses other than local mileage for local participants; (9) organization dues; (10) honoraria or other payments for the purpose of conferring distinction or communicating respect, esteem or admiration; (11) alterations or renovations; (12) indirect costs; and (13) travel or per diem costs for Federal employees.
6. Other Submission Requirements
Applicants are strongly encouraged to contact FDA to resolve any questions regarding criteria prior to the submission of their application. All questions of a technical or programmatic nature must be directed to the ORA program staff. All questions of an administrative or financial nature must be directed to the Grants Management Staff.
V. Application Review Information
All applications submitted in response to this RFA will first be reviewed for responsiveness by grants management and program staff.
2. Review and Selection Process
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, in consultation with the CDC Director and his or her designee.
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 missions 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.
VI. Award Administration Information
1. Award Notices
FDA urges applicants to submit work plans that address specific objectives of “Healthy People 2010.” Applicants may obtain a hard copy of the Healthy People 2010 objectives, Volumes I and II, for $70 ($87.50 foreign) S/N 017-000-00550-9, by writing to the Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Telephone orders can be placed to 202-512-2250. The document is also available in CD-ROM format, S/N 017-001-00549-5 for $19 ($23 foreign) as well as on the Internet at http://www.health.gov/healthypeople/. Internet viewers should proceed to “Publications.”
2. Administrative and National Policy Requirements
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 two copies of each report shall be submitted to FDA's Grants Management Office (address above). The report of the meeting should include: (a) the grant number; (b) the title, date and place 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 planned sessions of the meeting; and, (f) a summary of topics discussed, next steps and conclusions.
A Financial Status Report and a Progress Report are also required no later than 90 days after the close of the budget period. The 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 and/or a site visit with appropriate officials of the recipient organization. The results of these monitoring activities will be recorded in the official file and may be available to the recipient upon request.
VII. Agency Contacts
Regarding the administrative and financial management aspects of this notice: Michelle N. Caraffa (see ADDRESSES). Regarding the programmatic aspects of this notice: Stephen Toigo (see ADDRESSES).
VIII. Other Information
Unless disclosure is required by FOIA as amended (5 U.S.C. 552), as Start Printed Page 22893determined by the Freedom of Information officials of DHHS or by a court, data contained in the portions of an application which have been specifically identified by page number, paragraph, etc., by the applicant as containing restricted and/or proprietary information shall not be used or disclosed except for evaluation purposes.Start Signature
Dated: April 26, 2005.
Assistant Commissioner for Policy.
[FR Doc. 05-8819 Filed 5-2-05; 8:45 am]
BILLING CODE 4160-01-S