Funding Opportunity Title: Food Safety Task Force Conference Announcement Type: New Request for Applications Funding Opportunity Number: RFA-FDA-ORA-2005-3 Catalog of Federal Domestic Assistance (CFDA) Number(s):93-103, 22889-22893 [05-8819]

Download as PDF Federal Register / Vol. 70, No. 84 / Tuesday, May 3, 2005 / Notices 3. Effects of short- and long-term refrigerated storage on levels of L. monocytogenes in retail and foodservice establishments, 4. Impact of time and temperature on levels of L. monocytogenes in products stored in retail and foodservice establishments, 5. Efficacy of cleaning procedures and sanitizing agents on environmental surfaces and utensils, 6. Frequency of use and impact of adding inhibitors to food products in retail and foodservice establishments to reduce or prevent L. monocytogenes growth, and 7. Effect of training regarding hygienic practices and sanitation on levels of L. monocytogenes in products in retail and foodservice establishments. Interested persons were given until May 3, 2005, to submit comments and scientific data and information. The agency has received a request for a 60-day extension of the comment period for the notice. The request conveyed concern that the current 60day comment period does not allow sufficient time to develop a meaningful response to the notice. FDA has considered the request and is extending the comment period for the notice for an additional 60 days, until July 5, 2005. However, the agency does not anticipate granting any further extensions of the comment period. II. Request for Comments and for Scientific Data and Information Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments, scientific data, and information on this document. Submit a single copy of electronic comments, scientific data, and information or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: April 28, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–8838 Filed 4–29–05; 11:30 am] BILLING CODE 4160–01–S VerDate jul<14>2003 15:43 May 02, 2005 Jkt 205001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Funding Opportunity Title: Food Safety Task Force Conference Announcement Type: New Request for Applications Funding Opportunity Number: RFA– FDA–ORA–2005–3 Catalog of Federal Domestic Assistance (CFDA) Number(s):93–103 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: 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. DATES: The application receipt date is July 5, 2005. ADDRESSES: Applicants are strongly encouraged to apply electronically by visiting the Web site at https:// 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: mcaraffa@oc.fda.gov. Application forms PHS 5161–1 are available via the internet at: https:// 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. FOR FURTHER INFORMATION CONTACT: Regarding the administrative and financial management aspects of this notice: Michelle N. Caraffa (see ADDRESSES). PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 22889 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: stoigo@ora.fda.gov, or access the Internet at https://www.fda.gov/ora/ fedlstate/default.htm. For general ORA program information: Contact your Regional Food Specialists at https:// www.fda.gov/ora/fedlstate/ DFSRlActivities/food specialists.htm. 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. SUPPLEMENTARY INFORMATION: 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 E:\FR\FM\03MYN1.SGM 03MYN1 22890 Federal Register / Vol. 70, No. 84 / Tuesday, May 3, 2005 / Notices exchanges 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. A. 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 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 VerDate jul<14>2003 15:43 May 02, 2005 Jkt 205001 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 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 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 E:\FR\FM\03MYN1.SGM 03MYN1 Federal Register / Vol. 70, No. 84 / Tuesday, May 3, 2005 / Notices amount 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 None. 3. Other. 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 https:// 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 https://www.grants.gov/ CCRRegister. The applicant must register with the Credential Provider for Grants.gov. Information about this requirement is available at https:// 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: mcaraffa@oc.fda.gov. Applications forms PHS 5161–1 are available via the internet at: VerDate jul<14>2003 15:43 May 02, 2005 Jkt 205001 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 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 22891 on the Internet at: https://www.fda.gov/ ora/fedlstate/InnovativelGrants.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 E:\FR\FM\03MYN1.SGM 03MYN1 22892 Federal Register / Vol. 70, No. 84 / Tuesday, May 3, 2005 / Notices submit 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 60day 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 VerDate jul<14>2003 15:43 May 02, 2005 Jkt 205001 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 1. Criteria 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 https:// www.health.gov/healthypeople/. PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 Internet viewers should proceed to ‘‘Publications.’’ 2. Administrative and National Policy Requirements 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. 3. Reporting 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 E:\FR\FM\03MYN1.SGM 03MYN1 Federal Register / Vol. 70, No. 84 / Tuesday, May 3, 2005 / Notices determined 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. Dated: April 26, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–8819 Filed 5–2–05; 8:45 am] BILLING CODE 4160–01–S LaVerne Stringfield, Director, Office of Federal Advisory Committee Policy. [FR Doc. 05–8780 Filed 5–2–05; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health BILLING CODE 4140–01–M Notice of Meeting: Secretary’s Advisory Committee on Genetics, Health, and Society Pursuant to Pub. L. 92–463, notice is hereby given of the seventh meeting of the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS), U.S. Public Health Service. The meeting will be held from 8:30 a.m. to 5:30 p.m. on June 15, 2005 and 8:30 a.m. to 5:30 p.m. on June 16, 2005 at the Bethesda North Marriott Hotel, 5701 Marinelli Road, North Bethesda, Maryland. The meeting will be open to the public with attendance limited to space available. The meeting will be Webcast. The topics of the first day are expected to be genetic discrimination, direct-to-consumer marketing of genetic tests, and coverage and reimbursement of genetic tests and services. The Committee aims to finalize a report on coverage and reimbursement of genetic tests and services after considering public comments. The topics for the second day are expected to include large population studies of gene-environment interactions and pharmacogenomics. Time will be provided each day for public comments. Under authority of 42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended, the Department of Health and Human Services established SACGHS to serve as a public forum for deliberations on the broad range of human health and societal issues raised by the development and use of genetic technologies and, as warranted, to provide advice on these issues. The draft meeting agenda and other information about SACGHS, including information about access to the Webcast, will be available at the VerDate jul<14>2003 15:43 May 02, 2005 Jkt 205001 following Web site: https:// www4.od.nih.gov/oba/sacghs.htm. The Committee would welcome hearing from anyone wishing to provide public comment on any issue related to genetics, health and society. Individuals who would like to provide public comment or who plan to attend the meeting and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the SACGHS Executive Secretary, Ms. Sarah Carr, by telephone at 301–496–9838 or e-mail at sc112c@nih.gov. The SACGHS office is located at 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892. DEPARTMENT OF HEALTH AND HUMAN SERVICES 22893 this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute’s/Center’s home page: https:// deainfo.nci.nih.gov/advisory/dclg/dclg.htm, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS.) Dated: April 25, 2005. LaVerne Y. Stringfield, Director, Office of Federal Advisory Committee Policy. [FR Doc. 05–8779 Filed 5–2–05; 8:45 am] BILLING CODE 4140–01–M National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES National Cancer Institute; Notice of Meeting National Institutes of Health Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Cancer Institute Directors Consumer Liaison Group. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. National Center for Research Resources; Notice of Closed Meeting Name of Committee: National Cancer Institute Director’s Consumer Liaison Group. Date: May 26, 2005. Time: 3 p.m. to 5 p.m. Agenda: Opening remarks; approval of minutes February 28–March 1, 2005 DCLG meeting; NCI Director’s Remarks; reports from NCI Listens and Learns Working Groups: Operations Working Group, Summit Working Group, Promotions Working Group, and Evaluation Working Group; DCLG recommendations on the Progress Review Group Process; public comment; next steps. Place: National Institutes of Health, 6116 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Nancy Caliman, Executive Secretary, Office of Liaison Activities, National Institutes of Health, National Cancer Institutes, 6116 Executive Boulevard, Suite 220, MS8324, Bethesda, MD 20892, (301) 496–0307, calimann@mail.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Center for Research Resources Special Emphasis Panel. Date: May 6, 2005. Time: 11:30 a.m. to 12 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, One Democracy Plaza, 6701 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Barbara J. Nelson, PhD., Scientific Review Administrator, Office of Review, National Center for Research Resources, NIH, 6701 Democracy Blvd, Room 1080, 1 Democracy Plaza, Bethesda, MD 20892, (301) 435–0806. This notice is being published less than 15 days prior to the meeting due to the timing E:\FR\FM\03MYN1.SGM 03MYN1

Agencies

[Federal Register Volume 70, Number 84 (Tuesday, May 3, 2005)]
[Notices]
[Pages 22889-22893]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8819]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Funding Opportunity Title: Food Safety Task Force Conference 
Announcement Type: New Request for Applications Funding Opportunity 
Number: RFA-FDA-ORA-2005-3 Catalog of Federal Domestic Assistance 
(CFDA) Number(s):93-103

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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.

DATES: The application receipt date is July 5, 2005.

ADDRESSES: Applicants are strongly encouraged to apply electronically 
by visiting the Web site at https://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: mcaraffa@oc.fda.gov. Application forms PHS 5161-1 are 
available via the internet at: https://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.

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: 
stoigo@ora.fda.gov, or access the Internet at https://www.fda.gov/ora/
fed_state/default.htm.
    For general ORA program information: Contact your Regional Food 
Specialists at https://www.fda.gov/ora/fed_state/DFSR_Activities/food 
specialists.htm.

SUPPLEMENTARY 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

[[Page 22890]]

exchanges 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.

A. 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 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

[[Page 22891]]

amount 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
    None.
3. Other.
    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 https://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 
https://www.grants.gov/CCRRegister. The applicant must register with the 
Credential Provider for Grants.gov. Information about this requirement 
is available at https://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: 
mcaraffa@oc.fda.gov. 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: https://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

[[Page 22892]]

submit 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

1. Criteria
    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 https://www.health.gov/healthypeople/. Internet viewers 
should proceed to ``Publications.''
2. Administrative and National Policy Requirements
    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.
3. Reporting
    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

[[Page 22893]]

determined 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.

    Dated: April 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-8819 Filed 5-2-05; 8:45 am]
BILLING CODE 4160-01-S

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