[Federal Register Volume 70, Number 126 (Friday, July 1, 2005)]
[Notices]
[Pages 38177-38182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-13114]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Ruminant Feed Ban Support Project; Availability of Cooperative 
Agreements: Request for Applications: RFA-FDA-ORA-05-3; Catalog of 
Federal Domestic Assistance Number: 93.449

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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I. Funding Opportunity Description

    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 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 to support activities 
related to the FDA ruminant feed ban (21 CFR part 589.2000) (referred 
to as the ruminant feed ban), in State, territory, and tribal 
governments.
    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 also be used for supplies, training, and 
laboratory equipment for feed sample testing using FDA validated 
methods. 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 (the FD&C 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.

[[Page 38178]]

    There are seven key project areas identified for this effort:
     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.
     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 methodologies for detection of 
prohibited materials.
     Identify and inspect 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 within the State/territory/
tribal jurisdiction. These inspections would be conducted under section 
702 of the FD&C Act using and completing the FDA Ruminant Feed Ban 
Inspection Checklist and Ruminant Feed Ban Compliance Program to verify 
compliance with the ruminant feed ban. These inspections would be 
conducted by officers and employees duly commissioned by FDA in 
accordance with section 702 of the FD&C Act.
     Conduct surveillance sampling of renderers, protein 
blenders, and feed mills that manufacture with materials prohibited 
under the ruminant feed ban. 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 FD&C 
Act using and completing the FDA Ruminant Feed Ban Inspection Checklist 
and Ruminant Feed Ban Compliance Program to verify compliance with the 
ruminant feed ban. This surveillance sampling would be conducted by 
officers and employees duly commissioned by FDA in accordance with 
section 702 of the FD&C Act.
     Locate and inspect other firms of specified concern, such 
as feed salvagers, feed transporters, and ruminant feeders. These 
inspections would be conducted under section 702 of the FD&C Act using 
and completing the FDA Ruminant Feed Ban Inspection Checklist and 
Ruminant Feed Ban Compliance Program to verify compliance with the 
ruminant feed ban. These inspections would be conducted by officers and 
employees duly commissioned by FDA in accordance with section 702 of 
the FD&C Act.
     Provide copies of all completed BSE checklists and sample 
results as a part of the quarterly 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 
FD&C Act.
     Be able to identify and quantify improvements to the 
existing State/territory/tribal BSE program or developing new programs 
(i.e., personnel hiring, personnel training, equipment upgrades, 
increase in inspections conducted) in the quarterly reports as a result 
of the cooperative agreement.
    FDA will support the projects covered by this notice under the 
authority of Section 311 of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (the Bioterrorism Act) (Public 
Law 107-188), which amends the FD&C Act by adding section 909 (21 
U.S.C. 399). FDA's research program is described in the Catalog of 
Federal Domestic Assistance, No. 93.449.

1. Background

    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:
     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
     Title V--Additional Provisions
    Subtitle A of Title III--Protection of Food Supply, Section 311--
Grants to States for Inspections, amends the FD&C 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 FD&C 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 Feed/BSE 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 programs to help meet compliance 
with the regulation.

2. Program Goals

    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.

II. Award Information

1. Award Instrument

    Support will be in the form of a cooperative agreement. Substantive 
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:

[[Page 38179]]

     FDA assistance and coordination in the sharing of 
information on the identification and location of all 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 known to 
FDA and the State/territorial/tribal agency.
     FDA assistance in the training of State/territorial/tribal 
BSE program personnel.
     FDA assistance in the training of State/territorial/tribal 
laboratory personnel to verify that feed samples are free of materials 
prohibited under the ruminant feed ban.
     FDA assistance in the surveillance sampling of renderers, 
protein blenders, and feed mills that manufacture with materials 
prohibited under the ruminant feed ban.
     FDA assistance and cooperation in the location and 
inspection of other firms of specified concern, such as feed salvagers, 
feed transporters, and ruminant feeders.
     FDA will assist in the review of all completed checklists 
and sample results provided as a part of the quarterly reports.
     FDA will assist with joint inspections for training, 
compliance, auditing or other field activities as requested by the 
awardee.

2. Applicability

    All cooperative agreement projects that are developed at State, 
territorial, and tribal levels must have existing BSE feed safety and 
surveillance programs or propose in detail the development of a State/
territory/tribal feed/BSE regulatory program.

3. Award Amount

    The total amount of funding available in Fiscal Year (FY) 2005 is 
$2 million. Cooperative agreements will be awarded up to $250,000 in 
total (direct plus indirect) costs per year for up to three (3) years 
and can be modified for years 2 and 3, depending on the availability of 
funds and review of prior year's accomplishments.

4. Length of Support

    The length of support will depend on the nature of the project. For 
those projects with an expected duration of more than 1 year, a second 
or third year of noncompetitive continuation of support will depend on 
the following factors: (1) Performance during the preceding year and 
(2) availability of Federal funds.

5. Funding Plan

    It is anticipated that FDA will make up to ten awards in FY 2005. 
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.
    In addition, if a cooperative agreement is awarded, grantees will 
be informed if any additional documentation should be needed to support 
their award. Funds may be requested in the budget to travel to FDA for 
meetings with program staff about the progress of the project. The 
project office will have continuous interaction with the grantee 
through inspection field audits, collection of quarterly progress 
reports, and provision of training, joint inspections, and compliance. 
There may be other regular meetings with grantees to assist in 
fulfilling the requirements of the cooperative agreement.
    These cooperative agreements will be made to either fund the 
development of new State/territory/tribal BSE programs or to enhance 
existing State/territory/tribal BSE 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 
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.
    States with current BSE/ruminant feed ban contracts from FDA can 
maintain these contracts for feed/BSE 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. These cooperative agreements are not to fund licensed 
medicated feed or routine feed safety good manufacturing practice (GMP) 
inspections that are unrelated to the ruminant feed ban.

III. Eligibility Information

1. Eligible Applicants

    This cooperative agreement program is only available to State, 
territory, and tribal agency feed/BSE regulatory programs that 
undertake inspections and related activities under section 702 of the 
FD&C Act.

2. Cost Sharing or Matching

    Cost sharing is not required.

3. Other

    Dun and Bradstreet Number (DUNS).
    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.

IV. Application and Submission

1. Addresses to Request Application

    FDA is accepting new applications for this program electronically 
via Grants.gov. Applicants are strongly encouraged to apply 
electronically by visiting the Web site http://www.grants.gov and 
following instructions under ``APPLY.'' The required application PHS 
424, which is part of the PHS 5161-1 form, can be completed and 
submitted online. The package should be labeled ``Response to RFA-FDA-
ORA-05-3.'' If you experience technical difficulties with your online 
submission you should contact either Cynthia Polit, Grants Management 
Specialist, Division of Contracts and Grants Management (HFA-500), Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
827-7180, e-mail: [email protected] or the Grants.gov Customer Response 
Center for assistance.
    To comply with the President's Management Agenda, the Department of 
Health and Human Services is participating as a partner in the new 
governmentwide Grants.gov Apply site. Users of 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 site. We 
request your participation in the Grants.gov project. When you enter 
the Grants.gov site, you will find information about submitting an 
application electronically through the site.
    In order to apply electronically, the applicant must have a DUNS 
number and register in the Central Contractor Registration (CCR) 
database as described in section IV.6.A of this document.

[[Page 38180]]

2. Content and Form of Application

A. General Information
    The applicant will be judged on, and must specifically address, the 
following in the cooperative agreement application:
     Demonstrate the availability of adequately trained BSE 
program staff and/or the criteria to hire and/or train personnel to 
conduct ruminant feed ban inspections.
     Demonstrate the availability of adequately trained 
laboratory personnel and the criteria to hire and/or train laboratory 
personnel to verify that feed samples are free of materials prohibited 
under the ruminant feed ban. Verify that laboratory analyses will 
utilize FDA approved tests and methodologies for detection of 
prohibited materials.
     Provide a detailed description of current feed regulatory 
program or proposal to develop a feed regulatory program, including 
types of inspections performed, and types and numbers of feed 
establishments in the State/territorial/tribal inventory.
     Provide a properly detailed budget that is intended to 
develop or enhance the BSE program in the State/territory/tribe.
     Provide an accurate count of all feed facilities including 
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 in 
their State, territory, or tribal government. Provide an indication of 
how many of each of these facilities would be covered each year under 
this agreement.
     Provide a detailed description of how the BSE program 
inspections and/or feed sampling and analyses are to be performed.
     Provide detailed descriptions on how current, noninspected 
facilities and/or nonidentified facilities will be identified and added 
to the State's inspection responsibilities.
     Demonstrate the ability to satisfy the reporting 
requirements outlined in section VI.3.A of this notice.
     Provide current funding level certification for their 
existing BSE program from State/territory/tribal funding 
appropriations.
     Outline detailed methodology for program improvement or 
program development to accomplish the work.
     Provide justification for hiring new staff, hiring 
qualifications, their training needs and any new equipment.
     Provide a clearly detailed description how the State/
territory/tribe BSE program will follow the procedures set forth in 
section 702 of the FD&C Act for notifying FDA of violative facilities 
for enforcement under FDA jurisdiction.
B. Laboratory Facilities
    The applicant must provide a complete description of the 
facilities, including the following information: The name and address 
of the State/territory/tribal facility conducting the BSE testing; the 
name of the most responsible individual for the facility where the 
testing will be conducted; and, the location and installation 
requirements of any equipment purchased with cooperative agreement 
funds.
    Other facilities information that must be provided includes:
     Operational support areas to be used for the project, 
including details about the availability of ancillary laboratory safety 
and support equipment and facilities;
     Details describing the sample receiving and sample storage 
areas and a description of any existing chain-of-custody procedures;
     A detailed description of the proposed upgrades to 
existing laboratory facilities to accommodate new equipment including 
drawings and cost estimates.
    Laboratory Management Practices:
    For the laboratory, the following management information must be 
provided:
     A summary description of any quality management system 
defined, in development, or in place as it relates to quality control 
and quality assurance procedures and practices;
     A summary description of staffing management, specifically 
to include BSE testing abilities and procedures;
     A summary description of procedures in place to monitor 
BSE sample workflow, including the tracking and monitoring of sample 
analyses in progress to include a description of the laboratory work 
product review process. Additionally, the ability to perform and 
complete the BSE analyses and provide a report of a sample analysis 
within a responsive and reasonable timeframe must be described. At a 
minimum, the grantee shall utilize and follow the laboratory testing 
procedures, methodology, and protocol employed and approved by FDA in 
the testing of all BSE samples to ensure compliance with the ruminant 
feed ban.
    In addition, if a cooperative agreement is awarded, grantees will 
be informed if any additional documentation should be needed to support 
their award.
C. Format for Application
    Data and information included in the application will generally not 
be publicly available prior to the funding of the application. After 
funding has been granted, 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 5161-1 
(Rev. 7/00) have been sent by PHS to the Office of Management and 
Budget (OMB) and have been approved and assigned OMB control number 
0348-0043.

3. Submission Dates and Times

    For FY 05, the application receipt date is August 15, 2005.
    Applications will be accepted from 8 a.m. to 4:30 p.m., Monday 
through Friday, until the established receipt date. Please do not send 
applications to the Center for Scientific Review (CSR) at the National 
Institutes of Health (NIH). Any 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 nonresponsive and returned to the 
applicant.
    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.

4. Intergovernmental Review

    The regulations issued under Executive Order 12372, 
Intergovernmental Review of Federal Programs (45 CFR part 100) apply. 
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 located at: http//www.whitehouse.gov/omb/grants/spoc.htlm. The SPOC should send any State review process 
recommendations to the FDA administrative contact (see Agency Contacts 
in section VII of this document). The due date for the State process 
recommendations is no later than 60 days after the deadline date for 
the receipt of applications. FDA does

[[Page 38181]]

not guarantee to accommodate or explain SPOC comments that are received 
after the 60-day cutoff.

5. Funding Restrictions

    These cooperative agreements are not to fund licensed medicated 
feed or routine feed safety 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 programs or to enhance and supplement 
existing State/territory/tribal BSE program funding. States with 
current BSE/ruminant feed ban contracts from FDA can maintain these 
contracts for feed/BSE 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.

6. Other Submission Requirements

A. Central Contractor Registration
    In anticipation of the http://www.grants.gov electronic application 
process, applicants must register with the CCR database. This database 
is a governmentwide 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 governmentwide 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 http://www.ccr.gov. 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. You must have a DUNS number to begin your 
registration.
    In order to access http://grants.gov an applicant will be required 
to register with the Credential Provider. Information about this is 
available at http://www.grant.gov/CredentialProvider.
B. Copyright Material
    Applicants and applicants' sub-grantees and sub-contractors must 
ensure compliance that any projects developed in whole or in part with 
Federal funds may be made available to other State, territorial, local, 
and tribal feed/BSE 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.

V. Application Review Information

1. Criteria

A. General Information
    FDA grants management and program staff will review all 
applications sent in response to this notice. To be responsive, an 
application must be submitted in accordance with the requirements of 
this notice and must bear the original signature of the applicant 
institution's/organization's authorized official. Applications found to 
be nonresponsive will be returned to the applicant without further 
consideration. Applicants are strongly encouraged to contact FDA to 
resolve any questions about criteria before submitting their 
application. Please direct all questions of a technical or scientific 
nature to the ORA 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 original signature requirement does not apply to applications 
submitted electronically.
B. Scientific/Technical Review Criteria
    Applications will be considered for funding on the basis of their 
overall technical merit as determined through the review process. 
Program criteria will include availability of funds and overall program 
balance in terms of geography and with respect to existing inventory of 
feed firms within their State.
    The ad hoc expert panel will review applications based on the 
``Content and Form of Application'' requirements listed in section 
IV.2.A of this document.
    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 this ORA/Office of 
Regional Operations (ORO)/DFSR and CVM cooperative agreement program.
C. Program Review Criteria
    Applications will be considered for funding on the basis of their 
overall technical merit as determined through the review process. 
Program criteria will include availability of funds and overall program 
balance in terms of geography with respect to existing and projected 
awards.

2. Review and Selection Process

    Responsive applications 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. Final funding decisions will 
be made by the Commissioner of Food and Drugs or his designee.

3. Anticipated Announcement and Award

    Notification regarding the results of the review is anticipated by 
September 1, 2005. The expected start date for the FY 05 awards will be 
September 29, 2005.

VI. Award Administration Information

1. Award Notices

    The FDA Grants Management Office will notify applicants who have 
been selected for an award. Awards will either be issued on a Notice of 
Grant Award (PHS 5152) signed by the FDA Chief Grants Management 
Officer and be sent to successful applicants by mail or be transmitted 
electronically.

2. Administrative and National Policy Requirements

    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.
    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

[[Page 38182]]

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.''

3. Reporting

A. Reporting Requirements
    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 grant. For continuing 
cooperative agreements, an annual program progress report is also 
required. For such cooperative agreements, the noncompeting 
continuation application (PHS 5161-1) will be considered the annual 
program progress report.
    Quarterly progress reports as well as a final program progress 
report are required. Quarterly progress reports must contain, but are 
not limited to the following:
    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 FD&C Act result 
in a State/territorial/tribal enforcement action, a summary report of 
the followup actions and final resolution of the findings.
    8. Summary of improvements (identify and quantify) in the overall 
State/territory/tribal BSE program resulting from the cooperative 
agreement.
    9. Provide copies of all completed BSE checklists and sample 
results as a part of the quarterly program progress report to the FDA 
Project officer or designated office.
    The grantee must file a final program progress report, FSR, 
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.
B. Monitoring Activities
    The program project officer will monitor grantees 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 
cooperative agreement file and will be available to the grantee upon 
request consistent with applicable disclosure statutes and FDA 
disclosure regulations. The grantee organization must comply with all 
special terms and conditions of the cooperative agreement, including 
those that state that future funding of the study will depend on 
recommendations from the project officer. The scope of the 
recommendation will confirm that: (1) There has been acceptable 
progress on the project; (2) there is continued compliance with all FDA 
regulatory requirements; (3) if necessary, there is an indication that 
corrective action has taken place; and (4) assurance that any 
replacement of personnel will meet the testing and inspection 
requirements.

VII. Agency Contacts

    For issues regarding the administrative and financial management 
aspects of this notice: Cynthia Polit (see section IV.1 of this 
document).
    For issues regarding the programmatic or technical aspects of this 
notice: Neal Bataller, Center for Veterinary Medicine, Division of 
Compliance, Office of Surveillance and Compliance (HFV-235), Food and 
Drug Administration, 7500 Standish Pl., rm. E441, Rockville, MD 20855, 
240-276-9202, e-mail: [email protected] or Steve Toigo, Division of 
Federal-State Relations (HFC-150), Office of Regulatory Affairs, Food 
and Drug Administration, 5600 Fishers Lane, rm. 12-07, Rockville, MD 
20857, 301-827-6906, e-mail: [email protected] or access the Internet 
at http://www.fda.gov/ora/fed_state/default.htm.

VIII. Other Information

    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, by a court, 
or required by another Federal law, 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: June 27, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-13114 Filed 6-29-05; 9:03 am]
BILLING CODE 4160-01-S