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September 13, 2006
(Federal Register Notice September 13, 2006)
The Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), Office of Seafood (OS) is announcing its intent to award, noncompetitively, a cooperative agreement to the Interstate Shellfish Sanitation Conference (ISSC) in the amount of $320,500 for fiscal year 2006, direct and indirect costs combined. Subject to the availability of Federal funds and successful performance, four additional years of support will be available. This effort will enhance the FDA's molluscan shellfish sanitation program and provide the public greater assurance of the quality and safety of these products.
Molluscan shellfish have been identified as the source of a majority of seafood-borne illnesses and are the subject of congressional, industry, and public concern. FDA has, therefore, given high priority to enhance the agency program and to provide the public greater assurance of the quality and safety of these products. One such enhancement has been the incorporation of FDA's Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation into the National Shellfish Sanitation Program (NSSP) Model Ordinance. FDA administers the NSSP and the NSSP Model Ordinance, which serves as guidance for state shellfish sanitation programs and the promulgation of state regulations and laws concerning shellfish safety. The ISSC was formed in 1982 as a partnership of State shellfish control officials representing environmental and public health agencies, including local, Federal and foreign, to provide a formal structure wherein State regulatory authorities could establish updated guidelines, and procedures for the uniform application of those guidelines, for the sanitary control of the shellfish industry. Thirty-two States are members of the ISSC, including all twenty-three costal shellfish-producing States. It is a voluntary organization and is open to all persons interested in fostering controls that will ensure sources of safe and sanitary shellfish. In 1984, FDA recognized the ISSC through a Memorandum of Understanding (MOU) and continues to recognize ISSC as the primary voluntary national organization of State shellfish regulatory officials that will provide guidance and counsel to the States on matters of sanitary control of shellfish. In 1993, FDA awarded a non-competitive grant to ISSC for a year and, due to satisfactory performance, provided support for an additional two years. During the course of the project FDA received $75,000 annually from the Department of Commerce, National Oceanic and Atmospheric Administration, National Marine Fisheries Services (NMFS) to be included as additional support for this project. Combined with the NMFS funds, the ISSC cooperative agreement was funded for a total of $465,000 over the three year period. In February 1996 and again in February 2001, FDA awarded non-competitive cooperative agreements to ISSC for a year, with an additional four years for each award, based on satisfactory performance for each award segment. The approved funding level per year was $150,000.
Beginning in September 1996, FDA awarded supplemental funding to the ISSC cooperative agreement to provide for the implementation and enhancement of activities associated with Vibrio vulnificus and Vibrio parahaemolyticus.
Substantive accomplishments of the ISSC to date under this cooperative agreement include: Coordination of annual shellfish safety meetings of federal regulators, state regulators, and industry members for the purpose improving shellfish safety controls in the NSSP Model Ordinance; Facilitation, incorporation and implementation of HACCP into the NSSP Model Ordinance; Facilitation of the resolution of shellfish safety issues between states and FDA in several states; Coordination of the revision of NSSP Model Ordinance and assisted in its distribution and in making it available electronically online; Coordination of development and oversight of an interim Vibrio parahaemolyticus control plan; Development of an educational training video concerning illegal shellfish harvesting, and an education training video concerning the public health implications associated with the discharge of overboard waste discharges from harvest vessels; Development and maintenance of a World Wide Web site for continuous accessibility to molluscan shellfish safety related information;Coordination, development and oversight of a Vibrio vulnificus control plan; In conjunction with the FDA, conduct of retail and processing plant product sampling studies to examine Vibrio levels in molluscan shellfish that have undergone a post harvest process to reduce levels of Vibrios; and, in conjunction with FDA, development of a risk-based approach to evaluating state compliance with the NSSP Model Ordinance.
Other substantive accomplishments of the ISSC include: coordination of the development of shellstock time-temperature controls for Vibrio vulnificus and Vibrio parahaemolyticus; funding support for Vibrio vulnificus virulent strain identification research; funding support to research the effects of ice chilling on Vibrio vulnificus; funding support to research the influence of water and air temperature, dissolved oxygen, and nutrients on Vibrio parahaemolyticus concentrations in Pacific oysters; funding support to conduct a retail study to define levels of Vibrio vulnificus and Vibrio parahaemolyticus at points of purchase; funding support to conduct an economic assessment of mandating post-harvest treatment of oysters; development of a Vibrio vulnificus laboratory methodology training video; and, development and broadcast of a public service announcement to alert at risk consumers of the dangers associated raw shellfish consumption.
This project will (1) enhance both the effectiveness and uniformity of the molluscan shellfish program by: (a) improving the flow of information between Federal and State regulatory agencies, industry, and the consumer, and (b) strengthening State activities by providing assistance in such areas as procedural and policy guidance, technical training, research, consumer education, and the assurance of conformity to the NSSP; (2) provide for research on Vibrio vulnificus; and, (3) provide for research on Vibrio parahaemolyticus. This research is intended to provide information to establish science-based controls to protect consumers from Vibrio vulnificus and Vibrio parahaemolyticus infection. These efforts will provide information and data that can be used to reduce assumptions and tighten modeling outputs of the Vibrio vulnificus and Vibrio parahaemolyticus risk assessments developed by the Food and Agriculture Organization of the World Health Organization and the FDA respectively. The proposed cooperative agreement with ISSC will continue to: (1) address the need to improve information exchange and transfer among States, Federal Agencies, industry, and consumers; (2) strengthen state activities by providing them with procedural and policy guidance, technical training, research, and consumer education, and (3) enhance research efforts and projects which will contribute significantly to the ISSC/FDA ability to identify scientifically defensible controls which reduce the incidence of Vibrio vulnificus and Vibrio parahaemolyticus illness.
FDA will support the research covered by this notice under the authority of section 301 of the PHS Act. FDA's research program is described in the Catalog of Federal Domestic Assistance, No. 93.103. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and to discourage the use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. FDA is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a national effort designed to reduce morbidity and mortality and to improve quality of life. Applicants may obtain a paper copy of the "Healthy People 2010" objectives, vols. 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 ($23.50 foreign) as well as on the Internet at http://www.healthypeople.gov/. (FDA has verified the Web site address, but we are not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Internet viewers should proceed to "Publications."
Support for this project will be in the form of a cooperative agreement. This agreement will be subject to all policies and requirements that govern the research grant programs of the PHS, including provisions of 42 CFR Part 52 and 45 CFR 74 and 92. The regulations issued under Executive Order 12372 do not apply to this program. The NIH modular grant program does not apply to this FDA grant program.
FDA will fund this cooperative agreement at a level of approximately $320,500 for fiscal year 2006. An additional four years of support will be available, depending upon fiscal year appropriations, continued support from other government agencies and successful performance. It is anticipated that this cooperative agreement will commence on or before September 30, 2006. This five-year Cooperative Agreement may be supplemented during the project period if directed or requested by Congress.
The cooperative agreement will be funded initially for one year. An additional four years of noncompetitive continuation of support will depend on: (1) successful performance during the preceding year; and (2) the availability of Federal funds.
This award will be funded based on the quality of the application received and is subject to availability of Federal funds to support the project. In addition, if a cooperative agreement is awarded, the grantee will be informed of any additional documentation that should be submitted to FDA.
(1) FDA will monitor and evaluate the ISSC's overall conduct under this cooperative agreement. (2) FDA will have representation on the ISSC Executive Board, Committees and Task Forces.
(3) FDA will collaborate and work closely with ISSC on Vibrio vulnificus and Vibrio parahaemolyticus illness reduction and safety efforts. FDA will continue to work on developing the Vibrio vulnificus consumer education program; monitor state activities to ensure illness reduction goals of the ISSC Vibrio vulnificus control plan are met; monitor implementation of the interim Vibrio parahaemolyticus control plan; and, conduct regional meetings to examine controls measures that can be implemented on a regional basis to reduce Vibrio parahaemolyticus illnesses. (4) FDA will continue to work with ISSC to develop State program evaluation criteria. (5) FDA will work collaboratively with the ISSC to undertake a retail study of raw molluscan shellfish to examine the microbial quality of shellfish, including bacterial and viral pathogens.
(6) FDA will analyze state shellfish program data and information for the ISSC, and work through the ISSC to resolve any State shellfish program problems that may impact public health.
(7) FDA will conduct training courses in growing area classification, plant sanitation, and HACCP and plant standardization for participants of the ISSC, including online training modules.(8) FDA will work with the ISSC to develop new microbiological and marine biotoxin techniques and to develop and implement early warning systems for toxic algal blooms.
(9) FDA will continue to work with ISSC to establish a mechanism for incorporating new lab methods into the NSSP and to develop NSSP Model Ordinance interpretations. (10) FDA will take any action that may be necessary to ensure compliance with this cooperative agreement including, but not limited to conducting economic study on post harvest treatment processes, and developing patrol, growing area classification, and plant inspection criteria.
The ISSC is the only eligible source for this grant. ISSC was awarded these funds because it is the only organization that has the established form, structure, procedures and expertise to direct all components (public health, environmental, resource management and enforcement) of an effective shellfish sanitation program. The ISSC is a partnership of state shellfish control officials representing both environmental and public health agencies; Federal agencies, including the FDA, the Environmental Protection Agency (EPA), NMFS; and representatives from industry, academia and foreign governments. ISSC will continue to improve information exchange and transfer among State, Federal agencies, industry, academia and foreign governments. It will strengthen state activities by providing them with procedural and policy guidance, technical training, research and consumer education. It will also enhance research efforts and projects that will contribute significantly to the ISSC/FDA ability to identify scientifically defensible controls which reduce the incidence of Vibrio vulnificus and Vibrio parataemolyticus illness. Vibrio Vulnificus is a pathogen found in the estuarine environment. Vibrio Vulnificus bacteria are not normally a threat to healthy individuals. However, in individuals with pre-existing chronic medical conditions such as liver disease, alcoholism and hemochromatosis, Vibrio vulnificus can cause serious illness and death. Each year, between 12 and 40 cases of Vibrio vulnificus illness associated with consumption of raw molluscan shellfish are reported to public health authorities in the United States.
Vibrio parahaemolyticus is a pathogen found in the estuarine environment. Unlike Vibrio vulnificus, Vibrio parahaemolyticus bacteria can cause illness in healthy individuals. However, for individuals with pre-existing chronic medical conditions such as liver disease and alcoholism, Vibrio parahaemolyticus can cause serious illness and death. Each year, sporadic cases of Vibrio parahaemolyticus associated with raw molluscan shellfish consumption are reported to public health authorities in the United States. Recently, however, a number of Vibrio parahaemolyticus outbreaks associated with consumption of raw shellfish from the northern Pacific Coast, northern Atlantic Coast, and Gulf Coast have occurred.
Cost sharing is not required.
Since application submission through www.grants.gov (FDA has verified the Web site and its address, but we are not responsible for subsequent changes to the Web site or its address after this document published in the Federal Register.) will become mandatory in fiscal year 2007, the applicant is encouraged to use the grants.gov Web site to submit the application. Information on electronic submission can be found in 2.A. below.
If submitted as a paper copy, application requests and completed applications should be submitted to Dee Gibson, Grants Management Specialist, Division of Contracts and Grants Management (HFA-500), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301 827-7177, e-mail: . Applications that are hand-carried or commercially delivered should be addressed to 5630 Fishers Lane, rm. 2141, Rockville, MD 20857.
Do not send applications to the Center for Scientific Research (CSR), NIH.
FDA will accept the application for this program electronically via www.grants.gov. The applicant is encouraged to apply electronically by visiting the web site www.grants.gov and following instructions under "Apply for Grants." The required application, SF 424RR (Research & Related Portable Document Formats) can be completed and submitted online. The package should be labeled "Response to RFA-FDA-CFSAN-2006-1". If you experience technical difficulties with your online submission you should contact either the grants.gov Customer Response Center or Dee Gibson (see IV.1. above) for assistance.
To comply with the President's Management Agenda, HHS is participating as a partner in the new government-wide grants.gov apply site. Users of www.grants.gov will be able to download a copy of the application package, complete it offline, and then upload and submit the application via the grants.gov Web site. We encourage participation in the grants.gov project. Information about submitting an application electronically can be found on the www.grants.gov Web site.
To apply electronically, the applicant must have a DUNS number and register in the CCR database as described in section IV.5 of this document. If submitted other than electronically, please call Dee Gibson for guidance (see Addresses to Request application in section IV.1 of this document) prior to submission.
If submitted electronically, the application must be on SF424 Research and Related Portable Document Format. If submitted in paper copy, the application must be submitted on Grant Application Form PHS 398 (Rev. 5/01). All "General Instructions" and "Specific Instructions" in the application kit must be followed except for the receipt dates and the mailing label address in the PHS 398 package. The face page of the application, either electronic or paper, should reflect the request for applications number RFA-FDA-CFSAN-2006-1.
The applicant has the option of omitting from the application copies (but not from the original) specific salary rates or amounts for individuals specified in the application budget and Social Security numbers if otherwise required for individuals. The copies may include summary salary information.
Data and information included in the application will generally not be publicly available prior to the funding of the application. After funding has been awarded, data and information included in the application will be given confidential treatment to the extent permitted by the Freedom of Information Act (5 U.S.C. 552(b) (4)) and FDA's implementing regulations (including 21 CFR 20.61, 20.105, and 20.106). By accepting funding, the applicant agrees to allow FDA to publish specific information about the Cooperative agreement.
Information collection requirements requested on Form PHS 398 (Rev. 5/01) have been sent by the PHS to the Office of Management and Budget (OMB) and have been approved and assigned OMB control number 0925-0001. The requirement requested on Form FS 424 Research and Related Portable Documents Formats were approved and assigned OMB control number 4040-0001.
The application receipt date is [30 DAYS AFTER PUBLICATION DATE].
An application submitted electronically must be received by the close of business on the established receipt date.
If submitted as a paper copy, the application will be accepted from 8 a.m. to 4:30 p.m., Monday through Friday until the established receipt date. The application will be considered received on time if hand delivered to the address noted previously (see Addresses to Request Application in sections IV of this document) before the established receipt date, or sent or mailed by the receipt date as shown by a legible U.S. Postal Service dated postmark or a legible dated receipt from a commercial carrier. Private metered postmarks shall not be acceptable as proof of timely mailing.
An application 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, the applicant should check with their local post office). Please do not send the application to the CSR at NIH. An application sent to NIH/CSR that is forwarded to the FDA Grants Management Office and not received in time for orderly processing will be judged non-responsive and returned to the applicant. An application must be submitted via U.S. mail or commercial carrier or hand delivered as stated previously, unless submitted electronically.
There are no funding restrictions.
As of October 1, 2003, applicants are 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 that 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. Be certain that you identify yourself as a Federal grant applicant when you contact Dun and Bradstreet.
In anticipation of the grants.gov electronic application process, applicants are encouraged to register with the Central Contractor Registration (CCR) database. This database is a government-wide warehouse of commercial and financial information for all organizations conducting business with the Federal Government. Registration with CCR will eventually become a requirement and is consistent with the government-wide Management Reform to create a citizen-centered web presence and build e-gov infrastructures in and across agencies to establish a "single face to industry." The preferred method for completing a registration is through the World Wide Web at www.ccr.gov. (FDA has verified the Web site address, but we are not responsible for subsequent changes to the Web site or its address after this document publishes in the Federal Register.) This Web site provides a CCR handbook with detailed information on data you will need prior to beginning the online pre-registration, as well as steps to walk you through the registration process. Applicants must have a DUNS number to begin registration and should call Dun and Bradstreet, Inc., at the number listed in the previous paragraph if they do not have one. To access grants.gov an applicant will be required to register with the Credential Provider. Information about this is available at http://www.grants.gov/applicants/register_credential_provider.jsp. (FDA has verified the Web site address, but we are not responsible for subsequent changes to the Web site or its address after this document publishes in the Federal Register.)
In addition, if a Cooperative Agreement is awarded, the grantee will be informed of any additional documentation that should be submitted to FDA/CFSAN.
FDA grants management and program staff will review the application sent in response to this notice. To be responsive, the application must be submitted in accordance with the requirements of this notice and must bear the original signature of both the principal investigator and the applicant institution's/organization's authorized official. If the application is found to be non-responsive it will be returned to the applicant without further consideration. The applicant is strongly encouraged to contact FDA to resolve any questions about criteria before submitting the application. Please direct all questions of a technical or scientific nature to the CFSAN program staff and all questions of an administrative or financial nature to the grants management staff (see Agency Contacts in section VII of this document).
The application submitted by the ISSC will undergo non-competitive dual peer review. The application will be reviewed for scientific and technical merit by a panel of experts based upon the applicable evaluation criteria. If the application is recommended for approval, it will then be presented to the National Advisory Environmental Health Sciences Council for their concurrence. The ad hoc expert panel will review the application based on the following scientific and technical merit criteria:
1. The application clearly states an understanding of the purpose and objectives of the cooperative agreement in the overall seafood safety program and Vibrio research. 2. The application clearly describes the steps and a proposed schedule for planning, implementing and accomplishing the activities to be carried out under the cooperative agreement. 3. The application describes the applicant's ability to perform the responsibilities under this project by providing qualified staff. The application also demonstrates that the ISSC has the financial and other resources required for this project. 4. The application specifies the approach that the ISSC will use to maintain and to continue working with both the States and industry to ensure the exchange of the Vibrio vulnificus and Vibrio parahaemolyticus research projects and keeps the FDA informed of any significant advances in the understanding of or control of Vibrio vulnificus and Vibrio parahaemolyticus. In addition, the agency will determine whether the estimated cost of the project is reasonable. The application shall include a detailed budget that shows: (1) anticipated costs for personnel, travel, communications and postage, equipment, and supplies; and (2) the sources of funds to meet those needs.
A responsive application will be reviewed and evaluated for scientific and technical merit by an ad hoc panel of experts in the subject field of the specific application. A responsive application will be subject to a second review by a National Advisory Council for concurrence with the recommendations made by the first-level reviewers and funding decisions will be made by the Commissioner of Food and Drugs or his designee.
A score will be assigned based on the scientific/technical review criteria. The review panel may advise the program staff about the appropriateness of the proposal to the goals of the CFSAN Cooperative agreement program.
Notification regarding the results of the review is anticipated by August, 2006. The expected start date for this award will be September 30, 2006.
The FDA Grants Management Office will notify the applicant if they have been selected for an award. The award will either be issued on a Notice of Grant Award (PHS 5152) signed by the FDA Chief Grants Management Officer and be sent to the applicant by mail or be transmitted electronically.
The award will be subject to all policies and requirements that govern the research grants program of the PHS, including the provisions of 42 CFR part 52 and 45 CFR parts 74 and 92, and PHS'S Grants Policy Statement. The regulations issued under Executive Order 12372, Intergovernmental Review of Federal Programs (45 CFR Part 100) do not apply. The National Institutes of Health (NIH) modular grant program does not apply to this FDA grant program. The length of support will be 1 year. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and to discourage the use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. FDA is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010." A national effort designed to reduce morbidity and mortality and to improve quality of life. Applicants may obtain a paper copy of the "Healthy People 2010" objectives, vols. 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 ($23.50 foreign) as well as on the Internet at www.healthypeople.gov. (FDA has verified the Web site address, but we are not responsible for subsequent changes to the Web site or its address after this document publishes in the Federal Register.) Internet viewers should proceed to "Publications."
The original and two copies of the annual Financial Status Report (FSR) (SF-269) must be sent to FDA's grants management officer within 90 days of the budget period end date of the cooperative agreement. For continuing cooperative agreements, an annual program progress report is also required. For such cooperative agreements, the non-competing continuation application (SF 424) will be considered the annual program progress report.
FDA requires an annual Financial Status Report (FSR) (SF-269). Under FDA procedures, the original and two copies of this report must be submitted to FDA's Grants management Office within 90 days of the budget period expiration date. The awardee will conduct, when appropriate, an annual Single Audit as required by OMB Circular A-133. This audit must be submitted to the Federal Audit Clearinghouse at the Bureau of the Census within 9 months of the close of the awardees' fiscal year. An annual project progress report is required and the contents shall be suggested by the project officer. The annual progress report on the Vibrio vulnificus and Vibrio parahaemolyticus research projects shall include, but is not limited to, the following:(1) Listing and purpose of research projects funded;(2) Cost of each project; (3) Milestones and completion dates for each project; (4) Year-to-date results/scientific findings/public health findings of each project; (5) Potential Vibrio vulnificus and Vibrio parahaemolyticus and control measures/strategies suggested by research efforts. A final project progress report, FSR, and Invention Statement must be submitted within 90 days from the expiration date of the project period as noted on the Notice of Grant Award. Program monitoring will be conducted on an ongoing basis. Monitoring may be in the form of telephone conversations between the project officer/grants management specialists and the principal investigator. Site visits may be made by either program or grants management staff. The results of the visits will be recorded in the official grant file and may be available to the grantee upon request.
The program project officer will monitor the grantee periodically. The monitoring may be in the form of telephone conversations, e-mails or written correspondence between the project officer/grants management officer and the principal investigator. Periodic site visits with officials of the grantee organization may also occur. The results of these monitoring activities will be recorded in the official grant file and will be available to the grantee upon request consistent with applicable disclosure statutes and with FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the award, including those which state that future funding of the study will depend on recommendations from the project officer and the availability of Federal funds. The grantee must file a final program progress report, FSR and invention statement within 90 days after the end date of the project period as noted on the notice of grant award.
For issues regarding the administrative and financial management aspects of this notice: Dee Gibson (see Addresses to Request Application in Section IV of this document).
For issues regarding the programmatic aspects of this notice: Paul W. DiStefano, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1410, e-mail address: .
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 (5 U.S.C. 552(b)(4)) and FDA's implementing regulations (21 CFR 20.61).
Unless disclosure is required under the Freedom of Information Act as amended (5 U.S.C. 552) as determined by the freedom of information officials of the Department of Health and Human Services or by a court, data contained in the portions of this application that have been specifically identified by page number, paragraph, etc. by the applicant as containing restricted information, shall not be used or disclosed except for evaluation purposes.
Dated:__________________________
Associate Commissioner for Policy
