Food Safety and Security Monitoring Project, 42816-42819 [E8-16820]
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Federal Register / Vol. 73, No. 142 / Wednesday, July 23, 2008 / Notices
protection programs. Thus, unlike other
organizations, AFDO has a unique
perspective on the infrastructure,
capacity, strengths, and needs of State
and local food protection programs.
• AFDO has successful experience in
carrying out national efforts that focus
on the needs of State and local
regulatory agencies. FDA has used the
data from the initial AFDO State Food
Safety Resource Survey, AFDO model
codes, and training programs such as
the Seafood HACCP training program
certified through AFDO. AFDO has also
developed the AFDO Recall Manual and
many other training programs and
initiatives with the Centers for Disease
Control, the U.S. Department of
Agriculture, and others in meat and
poultry processing at retail. AFDO also
has industry associate members.
C. Award Amount
The total amount of funding available
for fiscal years 2008 through 2010 is
$250,000. This cooperative agreement
will award up to $250,000 in total
(direct plus indirect) costs for a 3-year
cooperative agreement.
D. Length of Support
The length of support for this project
will be 3 years.
E. Cost Sharing or Matching
Cost sharing is not required.
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IV. Application and Submission
A. Application Information
Applications must be prepared using
the most current SF424 (Research and
Related) (also referred to as the ‘‘SF424
(R&R)’’, which is part of the Public
Health Service, PHS 5161–1 form.
Applications must have a Dun and
Bradstreet Data Universal Numbering
System (DUNS) number as the universal
identifier when applying for Federal
grants or cooperative agreements. The
DUNS number can be obtained by
calling 866–705–5711 or through the
Web site at https://www.dnb.com/us/.
(FDA has verified the Web site
addresses throughout this document,
but we are not responsible for any
subsequent changes to the Web sites
after this document publishes in the
Federal Register.)
Applications must be prepared using
the forms found in the SF424 R&R
instructions for preparing a nonmodular
research grant application. Submit a
signed, typewritten original of the paper
application, including the checklist,
three signed photocopies, and appendix
material in one package to: Marc Pitts
(see FOR FURTHER INFORMATION CONTACT).
If you experience technical
difficulties with your online
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submission, you should contact either
Marc Pitts (see FOR FURTHER
INFORMATION CONTACT), or the Grants.gov
Customer Support Center by e-mail at
support@grants.gov or by phone at 1–
800–518–4726.
Information collection requirements
requested on Form (SF–424) PHS 5161–
1, expiration date of January 31, 2009,
have been sent by the PHS to the Office
of Management and Budget (OMB) and
have been approved and assigned OMB
control number OS–4040–0004.
B. 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. e.s.t., Monday through
Friday, until the established receipt
date. Applications submitted
electronically must be received by the
close of business on the established
receipt date. No addendum material will
be accepted after the established receipt
date.
C. Intergovernmental Review
The regulations issued under
Executive Order 12372,
Intergovernmental Review of Federal
Programs (45 CFR part 100) apply.
Applicants (other than federally
recognized 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 located at http//
www.whitehouse.gov/omb/grants/
spoc.html. 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 explanation of SPOC comments that
are received after the 60-day cutoff.
D. Funding Restrictions
This cooperative agreement is not to
fund annual, regional, or State meetings
of AFDO, travel for other than project
employees, equipment other than
consumables or as outlined in the
application, or any remodeling or
capital improvement to office location
or space.
E. Central Contractor Registration
Applicants must register with the
Central Contractor Registration (CCR)
database. This database is a governmentwide warehouse of commercial and
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financial information for all
organizations conducting business with
the Federal Government. Registration
with CCR is a mandatory requirement
and is consistent with the governmentwide management reform to create a
citizen-centered Web presence and to
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 https://www.ccr.gov.
This Web site provides a CCR handbook
with detailed information on data you
will need prior to beginning the online
preregistration, as well as steps to walk
you through the registration process.
You must have a DUNS number to begin
your registration. The CCR registration
process can also be found under the
‘‘Organization Registration’’ page of
Grants.gov at https://www.grants.gov/
applicants/organization_
registration.jsp.
F. Copyright Material
Applicant and applicants’ subgrantees
and subcontractors must ensure that any
projects developed in whole or in part
with Federal funds may be made
available to other State, territorial, local,
and tribal regulatory agencies by FDA or
its agents. Any copyrighted or
copyrightable works shall be subject to
a royalty-free, nonexclusive, and
irrevocable license to the Federal
Government to reproduce, publish, or
otherwise use them, and to authorize
others to do so for Federal Government
purposes.
Dated: July 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–16818 Filed 7–22–08; 8:45 am]
BILLING CODE 4160–01–S
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.
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
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Federal Register / Vol. 73, No. 142 / Wednesday, July 23, 2008 / Notices
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:
Marc.Pitts@fda.hhs.gov;
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:
jennifer.gabb@fda.hhs.gov; 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:
dean.turco@fda.gov.
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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 FDAregulated 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
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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,
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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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Federal Register / Vol. 73, No. 142 / Wednesday, July 23, 2008 / Notices
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
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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
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18:14 Jul 22, 2008
Jkt 214001
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
https://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 https://
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 https://
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
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(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
https://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 (https://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 support@grants.gov
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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Federal Register / Vol. 73, No. 142 / Wednesday, July 23, 2008 / Notices
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 https://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.
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on PROD1PC66 with NOTICES
[Docket No. FDA–2008–N–0038]
Peripheral and Central Nervous
System Drugs Advisory Committee;
Notice of Postponement of Meeting
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Aug<31>2005
18:14 Jul 22, 2008
Dated: July 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–16814 Filed 7–22–08; 8:45 am]
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Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3AN12, Bethesda, MD
20892, 301-594-3998,
trempemo@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
Dated: July 14, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–16512 Filed 7–22–08; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meeting
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
E. Funding Restrictions
AGENCY:
SUMMARY: The Food and Drug
Administration (FDA) is postponing the
meeting of the Peripheral and Central
Nervous Drugs Advisory Committee
scheduled for August 6 and 7, 2008.
This meeting was announced in the
Federal Register of July 8, 2008 (73 FR
39017). The postponement is due to
difficulties in empanelling the necessary
experts due to both scheduling conflicts
and conflict-of-interest issues.
FOR FURTHER INFORMATION CONTACT:
Diem-Kieu Ngo, Center for Drug
Evaluation and Research (HFD–21),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–827–7001, FAX: 301–827–6776, email: diem.ngo@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512543. Please call the Information
Line for up-to-date information on this
meeting.
42819
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 Institute of
General Medical Sciences, Special Emphasis
Panel, Drug Docking and Screening Resource.
Date: August 11, 2008.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications
Place: National Institutes of Health,
Natcher Building, 45 Center Drive 3AN12A,
Bethesda, MD 20892. (Telephone Conference
Call)
Contact Person: Mona R. Trempe, PhD.,
Scientific Review Officer, Office of Scientific
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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 Institute on
Drug Abuse, Special Emphasis Panel,
Mechanism for Time-Sensitive Research
Opportunities.
Date: August 5, 2008.
Time: 1 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6101
Executive Boulevard, Rockville, MD 20852.
(Telephone Conference Call)
Contact Person: Gerald L. McLaughlin,
PhD, Scientific Review Administrator, Office
of Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, Room 220, MSC
8401, 6101 Executive Blvd., Bethesda, MD
20892–8401, 301–402–6626,
gm145a@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
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]]>Agencies
[Federal Register Volume 73, Number 142 (Wednesday, July 23, 2008)]
[Notices]
[Pages 42816-42819]
From the Federal Register Online via the Government Printing 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.
-----------------------------------------------------------------------
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: Marc.Pitts@fda.hhs.gov;
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: jennifer.gabb@fda.hhs.gov; 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: dean.turco@fda.gov.
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
[[Page 42818]]
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 https://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 https://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 https://
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 https://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 (https://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 support@grants.gov 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
[[Page 42819]]
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 https://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
