
[Federal Register: July 9, 2008 (Volume 73, Number 132)]
[Notices]               
[Page 39316-39318]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy08-69]                         


[[Page 39316]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0369]

 
Ruminant Feed Ban Support Project; Availability of Cooperative 
Agreements Under a Limited Competition; Request for Applications: RFA-
FD-08-008; Catalog of Federal Domestic Assistance Number: 93.449

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) in 
coordination with the Center for Veterinary Medicine (CVM), is 
announcing the availability of cooperative agreements funding to 
further enhance the infrastructure of State, territorial, and tribal 
animal feed safety and bovine spongiform encephalopathy (BSE) 
prevention programs. These cooperative agreements are intended to fund 
additional personnel, equipment, supplies, and training support 
activities related to the FDA ruminant feed ban (referred to as the 
BSE/ruminant feed ban), in State, territory, and tribal governments. 
FDA anticipates providing approximately $1 million in direct plus 
indirect costs in support of this program in fiscal year (FY) 2008. It 
is anticipated that four awards will be made for up to $250,000 per 
award per year for up to 2 years.

DATES: The application receipt date is August 8, 2008.

ADDRESSES: Applications may be submitted on or after the opening date 
and must be successfully received by http://www.grants.gov\1\ no later 
than 5 p.m. local time (of the applicant institution/organization) on 
the application submission/receipt date. If an application is not 
submitted by the receipt date and time, the application may be delayed 
in the review process or not reviewed.
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    \1\ FDA has verified the non-FDA 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.
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    The required application, SF-424, can be completed and submitted 
online. The package should be labeled ``Response to RFA-FDA-08-008''. 
If you experience technical difficulties with your online submission 
you should contact Marc Pitts by telephone at 301-827-7162 or by e-mail 
at marc.pitts@fda.hhs.gov.
Paper applications will not be accepted.

FOR FURTHER INFORMATION CONTACT:
    Regarding the administrative and financial management aspects of 
this notice: Marc Pitts, Office of Acquisitions and Grants Management, 
Food and Drug Administration (HFA-500), 5630 Fishers Lane, suite 2104, 
Rockville MD 20857 (see also ADDRESSES).
    Regarding the programmatic aspects of this notice:Jennifer Gabb, 
Division of Federal-State Relations (DFSR), Office of Regulatory 
Affairs, 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.

SUPPLEMENTARY INFORMATION:

I. Introduction

    Under these cooperative agreements, the State, territory, and 
tribal governments would enhance their feed/BSE safety programs to 
increase the ability to locate and visit firms involved in the 
manufacture, distribution, and transportation of animal feed and 
operations feeding ruminant animals in their jurisdiction, to verify 
compliance with the ruminant feed ban. Funds could be used to increase 
State, territory, and tribal personnel dedicated to conducting these 
inspections. Funds could be used for supplies, training, and laboratory 
equipment for feed sample testing using FDA validation methods. Funds 
could also be used to conduct outreach educational activities and 
materials as needed to further and enhance the industries knowledge and 
compliance with ruminant feed ban.
    The goal of enhancing their feed/BSE safety programs is to increase 
State, territory, and tribal inspections under section 702 of the 
Federal Food, Drug, and Cosmetic Act (act) (21 U.S.C. 372) of 
renderers, protein blenders, and feed mills that manufacture animal 
feeds and feed ingredients, and inspections of salvagers of food and 
feed, and transporters of animal feed and feed ingredients utilizing 
materials prohibited under the ruminant feed ban. Finally, the Feed Ban 
Support Project funds are intended to supplement, not replace, State 
funding for program improvement.
    The following are seven key project areas identified for this 
effort: (1) Hire and/or train State/territory/tribal personnel to 
conduct ruminant feed ban inspections. Training of State/territory/
tribal personnel may be accomplished through the ORA University, or the 
Association of American Feed Control Officials Annual Feed Seminar, or 
other training that meets State/territory/tribal and FDA requirements. 
New hires for this program must meet the State/territory/tribal 
agency's qualifications for feed inspections and sampling techniques; 
(2) hire and/or train laboratory personnel to verify that feed samples 
are free of materials prohibited under the ruminant feed ban. 
Laboratory analyses must utilize FDA accepted methodologies for 
detection of prohibited materials; (3) identify and inspect renderers, 
protein blenders, commercial animal feed manufacturers, feed salvagers, 
distributors (including retailers), transporters of animal feed and 
feed ingredients, on-farm animal feed mixers, and ruminant feeders 
within the State/territory/tribal jurisdiction that have not already 
been identified and/or inspected for compliance with the ruminant feed 
ban. These inspections would be conducted under section 702 of the act 
using and completing the FDA Ruminant Feed Ban Inspection Checklist and 
Ruminant Feed Ban Compliance Program to verify compliance with the BSE/
ruminant feed ban. These inspections would be conducted by officers and 
employees duly commissioned by FDA in accordance with section 702 of 
the act; (4 ) conduct surveillance sampling of renderers, protein 
blenders, and feed mills that manufacture with materials prohibited 
under the BSE/ruminant feed ban. Sample feeds formulated without 
prohibited material. A minimum of one sample from each facility would 
be obtained during the inspection and would be analyzed by the State/
territorial/tribal government for prohibited materials. This 
surveillance sampling would be conducted under section 702 of the act 
using and completing the FDA Ruminant Feed Ban Inspection Checklist and 
Ruminant Feed Ban Compliance Program to verify compliance with the BSE/
ruminant feed ban. This surveillance sampling would be conducted by 
officers and employees duly commissioned by FDA in accordance with 
section 702 of the act; (5) provide copies of all completed BSE/
Ruminant Feed Ban checklists and sample results as a part of the mid-
year program progress report to the FDA Project officer or designated 
office, as well as provide completed checklists and sample results in 
accordance with section 702 of the act; (6) be able to identify and 
quantify improvements to the existing State/ territory/tribal BSE/
ruminant feed ban program or developing new programs (i.e., personnel 
hiring, personnel training, equipment upgrades, increase in inspections 
conducted) in the mid-year

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report as a result of the cooperative agreement; (7) conduct outreach 
educational activities and materials as needed to further and enhance 
the industries knowledge and compliance with ruminant feed ban.
    Please visit http://www.grants.gov to view the full version of this 
Request for Applications (RFA). FDA urges applicants to read the full 
version RFA in its entirety prior to submitting application packets.
    The events of September 11, 2001, reinforced the need to enhance 
the security and safety of the U.S. food supply. Congress responded by 
passing the Bioterrorism Act which President Bush signed into law on 
June 12, 2002. The Bioterrorism Act is divided into the following five 
titles: (1) Title I-- National Preparedness for Bioterrorism and Other 
Public Health Emergencies; (2) Title II--Enhancing Controls on 
Dangerous Biological Agents and Toxins; (3) Title III--Protecting 
Safety and Security of Food and Drug Supply; (4) Title IV--Drinking 
Water Security and Safety; and (5) Title V--Additional Provisions
    Subtitle A of Title III--Protection of Food Supply, Section 311--
Grants to States for Inspections, amends the act by adding section 909 
to authorize the Secretary of Health and Human Services to award grants 
to States, territories, and Indian tribes that undertake examinations, 
inspections, and investigations, and related activities under section 
702 of the act. The grant funds are only available for the costs of 
conducting these examinations, inspections, investigations, and related 
activities.
    Toward these ends, ORA is offering these cooperative agreements to 
State/ territorial/tribal governments for them to develop, new or 
enhance the capability of, their existing BSE/ruminant feed ban 
programs and assist in an increased surveillance presence throughout 
the commercial feed channels to prevent the introduction or 
amplification of BSE in the United States. State/territorial/ tribal 
inspections are based on a determination of compliance of firms with 
the ``Animal Proteins Prohibited In Ruminant Feeds'' regulation, (21 
CFR 589.2000), as well as any subsequent regulations and guidance 
applicable to the BSE/ruminant feed ban. This regulation is designed to 
prevent the establishment and amplification of BSE through animal feed, 
by prohibiting the use of certain proteins derived from mammalian 
tissue in the feeding of ruminant animals. The regulation affects 
renderers, protein blenders, commercial animal feed manufacturers, 
distributors (including retailers), transporters of animal feed and 
feed ingredients, on-farm animal feed mixers, and ruminant feeders. 
Based on the need to control the entry and spread of this disease, the 
agency has set a goal to assist in the development of new, or the 
enhancement of existing, State/territory/tribal BSE/ruminant feed ban 
programs to help meet compliance with the regulation.

II. Project Goals, Definitions, and Examples

    The goal of FDA's ORA Cooperative Agreement Program is to enhance, 
complement, develop, and improve State/territory/tribal feed safety and 
surveillance programs. This will be accomplished through the provision 
of funding for additional equipment, supplies, funding for personnel, 
training in current FDA approved feed testing methodologies, 
participation in proficiency testing to establish additional reliable 
laboratory sample analysis capacity, and analysis of surveillance 
samples and State/territorial/tribal compliance inspections. This will 
also require extensive cooperation and coordination with FDA District 
Offices to minimize duplication of inspections.
    These cooperative agreements will be made to either fund the 
development of new State/territory/tribal BSE/Ruminant Feed Ban 
programs or to enhance existing State/territory/tribal BSE/ruminant 
feed ban programs for the funding of items such as: Supplies, lab 
equipment, surveillance, sample collection, personnel, for the 
provision of training in current inspectional and analytical 
methodology, for the analysis of feed and feed products, and BSE/
ruminant feed ban inspections. Successful applications will be selected 
for funding to ensure a broad geographic distribution of the program. 
Size of the existing or new State/territory/tribal program and number 
of facilities to be covered under the cooperative agreement will also 
be a determining factor.
    These cooperative agreements are not to fund licensed medicated 
feed or routine feed safety good manufacturing practices (GMP) 
inspections that are unrelated to the ruminant feed ban. These awards 
may be only used for the development of new State/ territory/tribal 
BSE/ruminant feed ban programs or to enhance and supplement existing 
State/ territory/tribal BSE/ruminant feed ban program funding. States 
with current BSE/ruminant feed ban contracts from FDA can maintain 
these contracts for BSE/ruminant feed ban inspections at the discretion 
of the State and FDA. However, the facilities and work covered under 
the contract cannot be counted towards fulfillment of the cooperative 
agreement and must remain distinct and separate from the cooperative 
agreement.

III. Reporting Requirements

    A final Program Progress Report 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. In addition, 
the grantee must file an invention statement and disposition of 
equipment statement within 90 days after the end date of the project 
period as noted on the notice of the cooperative agreement award. An 
original and two copies of each report shall be submitted to Marc 
Pitts, Grants Management Office (see ''). The program progress report 
should include: (1) Status report on the installation and operational 
readiness of any analytical equipment that is purchased; (2) status 
report on the hiring and training of State/territorial/tribal 
laboratory personnel; (3) copies of the inspection report on the firms 
for which Ruminant Feed Ban Inspection checklists were completed 
including general assessment of compliance status; (4) summary report 
on the facility inventory that is maintained in the State/territory/
tribal government; (5) status report on the hiring and training of 
personnel to conduct the inspections; (6) report on feed sample 
descriptions and subsequent analytical results; (7) where the 
examinations, inspections, or investigations and related activities 
undertaken under section 702 of the act result in a State/territorial/
tribal enforcement action, a summary report of the follow up actions 
and final resolution of the findings; (8) summary of improvements 
(identify and quantify) in the overall State/territory/tribal BSE/
ruminant feed ban program resulting from the cooperative agreement; and 
(9) provide copies of all completed BSE/ruminant feed ban checklists 
and sample results as a part of the quarterly program progress report 
to the FDA Project officer or designated office.
    A Mid-Year Progress Report is also required no later than 90 days 
after the close of the budget period. The Mid-Year Progress Report 
should cover 6 months of activity including 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

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officer/grants management specialist and the principal investigator.
    When multiple years are involved, awardees will be required to 
submit the PHS Non-Competing Grant Progress Report SF-424 (5161) 
application http://www.hhs.gov/forms/PHS-5161-1.pdfannually and 
financial statements as required in the DHHS Grants Policy Statement. 
Reports must be submitted 2 months prior to the next budget period 
start date. The Progress Report should include a report of the previous 
meeting supported by the current grant, as well as a full description 
of the next planned meeting.

IV. Mechanism of Support

A. Award Instrument

    This funding opportunity will use the Research Demonstration 
Cooperative Agreements (U18) award mechanisms.
    This funding opportunity uses just-in-time budget concepts. It also 
uses the nonmodular budget format. Applicants must complete and submit 
a detailed categorical budget the SF-424 application.
    These agreements will be subject to all applicable policies and 
requirements that govern the grant programs of PHS, including 45 CFR 
part 92 and the PHS Grants Policy Statement.
    Equipment purchased under this cooperative agreement is subject to 
the requirements of 45 CFR part 92.31, ``Real property.''
    Applicants must adhere to the requirements of this Notice. Special 
Terms and Conditions regarding FDA regulatory requirements and adequate 
progress of the study may be part of the awards notice.
    PHS strongly encourages all cooperative agreement 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.

B. Eligibility

    This cooperative agreement program is only available to State/
territory/tribal agency feed/BSE regulatory programs that undertake 
inspections and related activities under section 702 of the act and who 
are currently not funded under this cooperative agreement.

C. Length of Support

    It is anticipated that FDA will fund these grants at a level 
requested but not exceeding $250,000 total direct plus indirect costs 
for the first year. An additional year (1) of support up to 
approximately $250,000 (direct plus indirect costs) per year will be 
available, depending upon fiscal year appropriations and successful 
performance. The length of support will also depend on the nature of 
the project.

D. Funding Plan

    Federal funds are currently available from FDA for this program. 
However, continued funding of a noncompetitive segment is contingent 
upon satisfactory progress as determined annually by FDA procedures, 
the receipt of a noncompeting continuation application, final yearly 
report and the availability of Federal funds. An estimated amount of $1 
million is available in FY 2008. The number of projects funded will 
depend on the quality of the applications received and is subject to 
availability of Federal funds to support the projects.

V. Review Procedure and Criteria

    All applications submitted in response to this request for 
applications (RFA) will first be reviewed for responsiveness by grants 
management and program staff. Responsiveness is defined as submission 
of a complete application packet on or before the required submission 
date as listed in the previous paragraphs. If applications are found to 
be nonresponsive, they will be returned to the applicant without 
further consideration.
    Responsive applications will be reviewed and evaluated for 
scientific and technical merit by an ad hoc panel of experts.
    Applicants are strongly encouraged to contact FDA to resolve any 
questions regarding criteria before the submission of their 
application. All technical or programmatic questions must be directed 
to the ORA program staff (see ADDRESSES). All administrative or 
financial questions must be directed to the Grants Management Staff 
(see ADDRESSES).

VI. Submission Requirements

    FDA is accepting new applications for this program electronically 
via http:www.grants.gov (Grants.gov). To download the SF424 application 
forms for this Funding Opportunity Announcement (FOA), link to ``Apply 
for Grants'' and follow the directions provided on that site. A one-
time registration is required for institutions at Grants.gov, link to 
``Get Registered.'' The application receipt date is July 30, 2008.
    Your organization will need to obtain a Data Universal Number 
System (DUNS) number as part of the Grants.gov registration process. 
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. The Dunn and Bradstreet number can be obtained by 
calling: 866-705-5711 or through the Web site at http://www.dnb.com/us/
. 
    The applicant must also register in the Central Contractor 
Registration (CCR) database in order to be able to submit the 
application. Information about the CCR is available at http://
www.ccr.gov or under the ``Organization Registration'' page of 
Grants.gov at:http://www.grants.gov/applicants/organization_
registration.jsp

VII. Method of Application

A. Submission Instructions

    The SF-424 (5161) application has several components. Some 
components are required, others are optional. The forms package 
associated with this FOA in Grants.gov (link to ``Apply for Grants '') 
includes all applicable components, required and optional.

B. Format for Application

    A completed application in response to this FOA includes the data 
in the following components:
    The face page of the application should indicate ``Response to 
Ruminant Feed Ban Support Project RFA-FDA-08-008.''
    For information that should be addressed in the application, please 
see the full version of this RFA at http://www.grants.gov.

VIII. Legend

    Unless disclosure is required by the Freedom of Information Act 
(FOIA) as amended (5 U.S.C. 552), as determined by the Freedom of 
Information (FOI) officials of the U.S. Department of Health and Human 
Services (HHS) 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: July 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-15561 Filed 7-8-08; 8:45 am]

BILLING CODE 4160-01-S
