[Federal Register Volume 73, Number 142 (Wednesday, July 23, 2008)]
[Notices]
[Pages 42816-42819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-16820]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0359]
Food Safety and Security Monitoring Project
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory
Affairs (ORA), Division of Federal-State Relations (DFSR), is
announcing the availability of cooperative agreements for equipment,
supplies, personnel, training, and facility upgrades to Food Emergency
[[Page 42817]]
Response Laboratory Network (FERN) chemistry laboratories of State,
local, and tribal governments. The cooperative agreements are to enable
the analyses of foods and food products in the event that redundancy
and/or additional laboratory surge capacity is needed by FERN for
analyses related to chemical terrorism. These grants are also intended
to expand participation in networks to enhance Federal, State, local,
and tribal food safety and security efforts.
DATES: Receipt Date: Applications are due within 30 days after the
publication of the funding opportunity in the Federal Register.
FOR FURTHER INFORMATION CONTACT:
For issues regarding the administrative and financial management
aspects of this notice: Marc Pitts, Division of Acquisition Support and
Grants, Food and Drug Administration, 5630 Fishers Lane, Rockville, MD
20857, 301-827-7162, e-mail: [email protected];
Regarding the programmatic aspects of this notice: Jennifer Gabb,
Division of Federal-State Relations, Food and Drug Administration (HFC-
150), 5600 Fishers Lane, rm. 12-07, Rockville, MD 20857, 301-827-2899,
e-mail: [email protected]; and
For technical aspects of this notice: Dean Turco, Division of Field
Science, Food and Drug Administration (HFC-140), 5600 Fishers Lane, rm.
12-41, Rockville, MD 20857, 301-827-4097, e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
Announcement Type: New Competing Cooperative Agreement (U18) under a
Limited Competition
Request for Applications (RFA) Number: RFA-FD-08-009
Catalog of Federal Catalog of Federal Domestic Assistance Number:
93.448
ORA is the primary inspection and analysis component of FDA and has
approximately 1,600 investigators, inspectors, and analysts who cover
the country's approximately 95,000 FDA-regulated businesses. These
investigators inspect more that 15,000 facilities per year and ORA
laboratories analyze several thousand samples per year. ORA conducts
special investigations, conducts food inspection recall audits,
performs consumer complaint inspections, and collects samples of
regulated products. Increasingly, ORA has been called upon to expand
the testing program addressing the increasing threat to food safety and
security through intentional chemical terrorism events. Toward these
ends, ORA has developed a suite of chemical screening and analysis
methodologies that are used to evaluate foods and food products in such
situations. However, in the event of a large-scale emergent incident,
analytical sample capacity in ORA field laboratories has a finite
limit. Information from ongoing relationships with State partners
indicates limited redundancy in State food testing laboratories, both
in terms of analytical capabilities and analytical sample capacity.
Several State food testing laboratories lack the specialized equipment
to perform the analyses and/or the specific methodological expertise in
the types of analyses performed for screening foods and food products
involving chemical terrorism events.
The events of September 11, 2001, reinforced the need to enhance
the security of the U.S. food supply. Congress responded by passing the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002 (the Bioterrorism Act) (Public Law 107-188), which President
George W. Bush signed into law on June 12, 2002. The Bioterrorism Act
is divided into the following five titles:
Title I--National Preparedness for Bioterrorism and Other Public
Health Emergencies,
Title II--Enhancing Controls on Dangerous Biological Agents and
Toxins,
Title III--Protecting Safety and Security of Food and Drug Supply,
Title IV--Drinking Water Security and Safety, and
Title V--Additional Provisions.
Subtitle A of the Bioterrorism Act, Protection of Food Supply,
section 312--Surveillance and Information Grants and Authorities,
amends part B of Title III of the Public Health Service Act to
authorize the Secretary of Health and Human Services (the Secretary) to
award grants to States and tribes to expand participation in networks
to enhance Federal, State, and local food safety efforts. This may
include meeting the costs of establishing and maintaining the food
safety surveillance, technical, and laboratory capacity needed for such
participation.
Project Emphasis
The goal of ORA's cooperative agreement program is to complement,
develop, and improve State, local, and tribal food safety and security
testing programs. This will be accomplished through the provision of
equipment, supplies, personnel, facility upgrades, training in current
food testing methodologies, participation in proficiency testing to
establish additional reliable laboratory sample analysis capacity,
analysis of surveillance samples, and in cooperation with FDA,
participation in method enhancement activities designed to extend
analytical capabilities. In the event of a large-scale chemical
terrorism event affecting foods or food products, the recipient may be
required to perform selected chemical analyses of domestic and imported
food samples collected and supplied to the laboratory by FDA or other
government agencies through FDA. These samples may consist of, but are
not limited to, the following: Vegetables and fruits (fresh and
packaged), juices (concentrate and diluted), grains and grain products,
seafood and other fish products, milk and other dairy products, infant
formula, baby foods, bottled water, condiments, and alcoholic products
(beer, wine, scotch).
II. Award Information
Mechanism of Support
All grant application projects that are developed at State, local,
and tribal levels must have national implication or application that
can enhance Federal food safety and security programs. At the
discretion of FDA, successful project formats will be made available to
interested Federal, State, local, and tribal government FERN
laboratories.
There are four key project areas identified for this effort that
must be addressed:
1. The use of gas chromatography/mass spectrometry analysis for the
screening and identification of poisons, toxic substances, and unknown
compounds in foods;
2. The use of liquid chromatography/mass spectrometry analysis for
the screening and identification of poisons, toxic substances, and
unknown compounds in foods;
3. The use of inductively coupled plasma/mass spectrometry analysis
for the screening and identification of heavy metals and toxic elements
in foods; and
4. The use of enzyme-linked immunosorbent assay and other antibody-
based analyses for the screening and identification of unknown toxins
in foods.
FDA will support the projects covered by this document under the
authority of section 312 of the Bioterrorism Act. This program is
described in the Catalog of Federal Domestic Assistance under number
93.448.
Support will be in the form of a cooperative agreement. Substantive
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involvement by the awarding agency is inherent in the cooperative
agreement award. Accordingly, FDA will have substantial involvement in
the program activities of the project funded by the cooperative
agreement. Substantive involvement includes, but is not limited to, the
following: (1) How often samples will be sent, (2) directions on how
tests should be executed, (3) onsite monitoring, (4) supply of
equipment, (5) FDA training on processes, and (6) enhancement and
extension of analytical methodology.
FDA will provide specific procedures and protocols for the four
project areas to be used for the analysis of toxic chemicals and toxins
in food.
FDA will provide guidance on the specific foods to be collected for
analysis by the successful applicant. FDA will purchase and have all
needed major equipment for the four project areas delivered to the
awardee's laboratory. The equipment purchased will remain the property
of FDA until such time as it is released as surplus property.
Only proposed projects designed to address all four project areas
will be considered for funding. Applicants may also apply for only
facility upgrades, personnel, training, method extension, and
surveillance sample analysis if they have the necessary equipment and
it will be available for these projects. These grants are not to fund
or conduct food inspections for food safety regulatory agencies.
It should be emphasized that in all of the projects, there is a
particular desire to promote a continuing, reliable capability and
capacity for laboratory sample analyses of foods and food products for
the rapid detection and identification of toxic chemicals or toxins.
With this in mind, it is desirable that sample analyses will be
completed no later than 2 weeks after receipt, and the results will be
reported to FERN. The format and reporting media will be established by
FERN. Shorter timeframes may be sought for special testing such as
proficiency tests or special assignments.
III. Eligibility Information
A. Eligible Applicants
This cooperative agreement program is only available to State,
local, and tribal government FERN laboratories that currently are not
funded under this cooperative agreement and is authorized by section
312 of the Bioterrorism Act. All grant application projects that are
developed at State, local, and tribal levels must have national
implication or application that can enhance Federal food safety and
security programs. At the discretion of FDA, successful project formats
will be made available to interested Federal, State, local, and tribal
government FERN laboratories.
B. Cost Sharing or Matching
Cost sharing is not required.
IV. Application and Submission
A. Application Information
In order to apply electronically, the applicant must complete the
following steps:
Step 1: Obtain a Dun & Bradstreet Number (DUNS Number)
Same day. Your organization will need to obtain a DUNS Number. If
your organization doesn't already have one, go to the Dun & Bradstreet
Web site at http://fedgov.dnb.com/webform.
Step 2: Register with the Central Contractor Registry (CCR)
Two days or up to 1 to 2 weeks. Ensure that your organization is
registered with the CCR at http://www.ccr.gov. If your organization is
not already registered, an authorizing official of your organization
must register. You will not be able to move on to Step 3 until this
step is completed.
Step 3: Obtain Username and Password
Same day. Create a username and password with Operational Research
Consultants (ORC), the Grants.gov credential service provider. Use your
organization's DUNS Number to access the ORC Website at http://apply07.grants.gov/apply/OrcRegister.
Step 4: Grants.gov Registration
Same day. Register with Grants.gov at https://apply07.grants.gov/apply/GrantsgovRegister to open an account using the username and
password you received from ORC.
Step 5: Authorized Organization Representative (AOR) Authorization
Time depends on responsiveness of your E-Business Point of Contact
(E-Biz POC). The E-Biz POC at your organization must respond to the
registration e-mail from Grants.gov and login at Grants.gov to
authorize you as an AOR. Please note that there can be more than one
AOR for your organization. In some cases the E-Biz POC is also the AOR
for an organization.
Step 6: Track AOR Status
At any time, you can track your AOR status at the Applicant home
page of Grants.gov in ``Quick Links'' by logging in with your username
and password (https://apply07.grants.gov/apply/ApplicantLoginGetID).
FDA is accepting new applications for this program electronically
via Grants.gov. Applicants must apply electronically by visiting the
Web site http://www.grants.gov and following instructions under ``APPLY
FOR GRANTS.'' The required application SF424, which is part of the PHS
5161-1 form, can be completed and submitted online by selecting Step 1:
``Download a Grant Application Package,'' then by entering the funding
opportunity number ``RFA-FD-08-009.'' The ``Selected Grant Applications
For Download'' page will provide you with the Additional Resources
downloads for Adobe Reader and PureEdge Viewer as well as the download
to the ``Instructions & Application'' hyperlink.
B. Content and Form of Application
1. Content of Application
The SF424 PHS-5161 has several components. Some components are
required, others are optional. The forms package associated with this
request for application (http://www.Grants.gov/Apply) includes all
applicable components. If you experience technical difficulties with
your online submission you should contact either Marc Pitts (see FOR
FURTHER INFORMATION CONTACT) or the Grants.gov Customer Support Center
by e-mail at [email protected] or by phone at 1-800-518-4726.
2. Format for Application
All applications must be submitted electronically through
Grants.gov. Paper applications will not be accepted. The application
must be an SF424-PHS-5161. The narrative portion, excluding appendices,
of the application may not exceed 100 pages in length and must be
single-spaced in 12-point font. The appendices should also not exceed
100 pages in length (separate from the narrative portion of the
application).
Information collection requirements requested on Form (SF-424) PHS
5161-1, expiration date of January 31, 2009, have been sent by the
Public Health Service (PHS) to the Office of Management and Budget
(OMB) and have been approved and assigned OMB control number OS-4040-
0004.
C. Submission Dates and Times
The application receipt date is 30 days after the publication of
the funding opportunity in the Federal Register. Applications will be
accepted from 8 a.m. to 4:30 p.m., Monday through Friday, until the
receipt date. Applications submitted electronically must be received by
close of business on
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the receipt date. No addendum material will be accepted after the
receipt date.
D. Intergovernmental Review
The regulations issued under Executive Order 12372,
Intergovernmental Review of Department of Health and Human Services
Programs and Activities (45 CFR part 100), apply to the Food Safety and
Security Monitoring Project. Applicants (other than federally
recognized Indian tribal governments) should contact the State's Single
Point of Contact (SPOC) as early as possible to alert the SPOC 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 or at http://www.whitehouse.gov/omb/grants/spoc.html. (FDA has verified the Web site address, but FDA is not
responsible for subsequent changes to the Web site after this document
publishes in the Federal Register.) The SPOC should send any State
review process recommendations to the FDA administrative contact (see
FOR FURTHER INFORMATION CONTACT). The due date for the State process
recommendations is no later than 60 days after the application receipt
date. FDA does not guarantee accommodation or explaination of SPOC
comments that are received after the 60-day cutoff.
E. Funding Restrictions
These grants are not to fund or conduct food inspections for food
safety regulatory agencies. They may not be utilized for new building
construction, however, remodeling of existing facilities is allowed,
provided that remodeling costs do not exceed 25 percent of the grant
award amount.
Dated: July 7, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-16820 Filed 7-22-08; 8:45 am]
BILLING CODE 4160-01-S