[Federal Register Volume 70, Number 100 (Wednesday, May 25, 2005)]
[Notices]
[Pages 30121-30126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-10435]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Food Safety and Security Monitoring Project; Availability of 
Cooperative Agreements; Request for Applications: RFA-FDA-ORA-05-1; 
Catalog of Federal Domestic Assistance Number: 93.448

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

I. Funding Opportunity Description

    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 
Response Laboratory Network (FERN) 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.
    The goal of ORA's cooperative agreement program is to complement, 
develop, and improve State, local, and Indian tribal food safety and 
security testing programs. With cooperative agreement grant funds this 
will be accomplished through the provision of supplies, personnel, 
facility upgrades, training in current food testing methodologies, 
participation in proficiency testing to establish additional reliable 
laboratory sample analysis capacity, and analysis of surveillance 
samples. 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 
Federal 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).
    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:
    (1) The use of Gas Chromatography/Mass Spectrometry (GC/MS) 
analysis for the screening and identification of poisons, toxic 
substances, and unknown compounds in foods;
    (2) The use of Liquid Chromatography/Mass Spectrometry (LC/MS) 
analysis for the screening and identification of poisons, toxic 
substances, and unknown compounds in foods;
    (3) The use of Inductively Coupled Plasma/Mass Spectrometry (ICP/
MS) analysis for the screening and identification of heavy metals and 
toxic elements in foods; and,
    (4) The use of Enzyme-Linked Immunosorbent Assay (ELISA) and other 
antibody-based analyses for the screening and identification of unknown 
toxins in foods.
    FDA will support the projects covered by this notice under the 
authority of section 312 of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (the Bioterrorism Act) (Public 
Law 107-188). This program is described in the Catalog of Federal 
Domestic Assistance under number 93.448.

1. Background

    ORA is the primary inspection and analysis component of FDA and has 
some 1,600 investigators, inspectors, and analysts who cover the 
country's approximately 95,000 FDA regulated

[[Page 30122]]

businesses. These investigators inspect more that 15,000 facilities a 
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 United States food supply. Congress responded by 
passing the Bioterrorism Act, 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 Indian 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.

2. Program Research Goals

    The goal of ORA's cooperative agreement program is to complement, 
develop, and improve State, local, and Indian 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, and participation in 
proficiency testing to establish additional reliable laboratory sample 
analysis capacity and analysis of surveillance samples. 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 Federal 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

    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: (1) How often samples will be sent, (2) directions on how 
tests should be executed, (3) on-site monitoring, (4) supply of 
equipment, and (5) FDA training on processes.
    FDA will provide specific procedures and protocols for the four 
project areas (see section I of this document) to be used for the 
analysis of toxic chemicals and toxins in food.
    FDA will provide guidance on the specific foods to be collected and 
analyzed by the successful applicant. State personnel will be 
responsible for the collection and analysis of surveillance samples.
    FDA will purchase and have all equipment delivered to the awardee's 
laboratory. The equipment purchased will remain the property of FDA 
until such time as released as surplus property.
    Proposed projects designed to fulfill the specific objectives of 
any one or more of the project areas will be considered for funding. 
Applicants may also apply for only facility upgrades, personnel, 
training, and surveillance sample collection 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 within 2 weeks of receipt, and the results will be reported 
to FERN. The format and reporting media will be established by FERN.

1. Award Amount

    The total amount of funding available in Fiscal Year (FY) 2005 is 
$2,100,000. Cooperative agreements will be awarded up to $350,000 in 
total (direct plus indirect) costs per year for up to 3 years. It is 
anticipated that six awards will be made. Support of these cooperative 
agreements will be for the funding of supplies, facility upgrades, 
surveillance sample collection, personnel, the provision of training in 
current analytical methodology, and for the analysis of foods and food 
products.

2. 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 
performance during the preceding year and availability of Federal 
funds.

3. Funding Plan

    It is anticipated that FDA will make six awards in FY 2005 for this 
program. 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.
    Funds may be requested in the budget to travel to FDA for meetings 
with program staff about the progress of the project.

III. Eligibility Information

1. Eligible Applicants

    This cooperative agreement program is only available to State, 
local, and tribal government FERN laboratories 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

[[Page 30123]]

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.

2. Cost Sharing or Matching

    Cost sharing is not required.

3. Other

A. 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 & Bradstreet, Inc.

IV. Application and Submission

1. Addresses to Request Application

    The application request and the completed application should be 
submitted to 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 [email protected]. If the application 
is hand-carried or commercially delivered it should be addressed to 
5630 Fishers Lane, rm. 2105, Rockville, MD 20857.
    The original and two copies of the completed grant application form 
PHS 5161-1, with copies of the appendices for each of the copies, 
should be submitted to Cynthia Polit (see previous paragraph). The 
outside of the mailing package should be labeled ``Response to RFA-FDA-
ORA-05-1.''
    FDA is also accepting 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 the instructions under ``APPLY.'' 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.
    If the submission is electronic, the application package is posted 
under the ``APPLY'' section of this announcement under http://www.grants.gov. The required application PHS 424, which is part of the 
PHS 5161-1 form, can be completed and submitted online.

2. Content and Form of Application

A. Content of Application
    The applicant must specifically address the following in the 
cooperative agreement application:
    Laboratory Facilities. A complete description of the name and 
address of the facility, and the name of the most responsible 
individual of the facility where the equipment will be installed must 
be provided.
    For the facility, the following information must be provided:
    (1) Floor diagrams of the laboratory;
    (2) Area where the equipment is to be installed. The installation 
of equipment in a laboratory will require adequate and appropriate 
space and physical plant supplies (power, water, etc.);
    (3) A description of the envisaged space, to include a floor-plan 
diagram;
    (4) Operational support areas to be used for the project, including 
details about the availability of ancillary laboratory safety and 
support equipment and facilities, such as the numbers and types of 
chemical fume hoods available;
    (5) Details describing the sample receiving and sample storage 
areas and a description of any existing chain-of-custody procedures;
    (6) A detailed description of the proposed facilities upgrade 
including drawings and cost estimates; and
    (7) A detailed description of laboratory access procedures, 
including a description of practices and systems which limit access to 
laboratory space by unauthorized personnel. Additional procedures for 
access to the space(s) dedicated to the equipment provided, if any, 
should also be provided.
    Laboratory Personnel Qualifications. Qualifications of all 
personnel that will be assigned to the project must be provided. In 
particular, information on personnel that have experience in GC/MS, LC/
MS, ICP/MS, and ELISA must be provided.
    Laboratory Management Practices. For the laboratory, the following 
management information must be provided:
    (1) A summary description of any security procedures or processes 
to evaluate the background of laboratory personnel. This should include 
any procedures to evaluate subcontractors who have access to laboratory 
space, such as cleaning personnel;
    (2) 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;
    (3) A summary description of staffing management, specifically to 
include abilities and procedures in place to recall personnel, 
establish extended workweeks, etc.; and
    (4) A summary description of procedures in place to monitor 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 analyses 
and provide a report of a sample analysis within a 2-week time frame 
must be described.
    Sample Analysis Commitment. The laboratory will be required to 
analyze surveillance and emergency response food samples. Therefore, an 
estimate of the number of food samples that will be analyzed for toxic 
chemicals and toxins by each project area (i.e., GC/MS, LC/MS, ICP/MS, 
ELISA), must be submitted. This estimate should be for a 3-year period. 
The estimate should also address the number of samples that can be 
analyzed in a 2-week period. The procedures to be used will be supplied 
by FDA. This information will be provided after the award is given so 
recipients will be aware of requirements/responsibilities.
    In addition, if a cooperative agreement is awarded, awardees will 
be informed of any additional documentation that should be submitted to 
FERN.
B. Format for Application
    Submission of the application must be on grant application form PHS 
5161-1 (revised 7/00). All ``General Information Instructions'' and 
specific instructions in the application kit must be followed. The face 
page of the application should reflect the request for application 
number RFA-FDA-ORA-05-1 under ``Federal Identifier.''
    Data and information included in the application will generally not 
be available publicly prior to the funding of the application. After 
funding has been awarded, data and information included in the 
application will be given confidential treatment to the extent 
permitted by the Freedom of Information Act (5 U.S.C. 552(b)(4)) and 
FDA's implementing regulations (including 21 CFR 20.61, 20.105, and 
20.106 (21 CFR 20.61, 20.105, and 20.106)). By accepting funding, the 
applicant agrees to allow ORA to publish specific information about the 
grant.
    The requirements requested on form PHS 5161-1 (revised 7/00) have 
been sent by PHS to the Office of Management and Budget (OMB) and have 
been approved and assigned OMB control number 0248-0043.

[[Page 30124]]

3. Submission Dates and Times

    The application receipt date is June 24, 2005.
    Applications will be accepted from 8 a.m. to 4:30 p.m., Monday 
through Friday, until the established receipt date. Applications will 
be considered received on time if hand delivered to the address noted 
previously (see Addresses to Request Application in section IV of this 
document) before the established receipt date, or sent or mailed by the 
receipt date as shown by a legible U.S. Postal Service dated postmark 
or a legible dated receipt from a commercial carrier. Private metered 
postmarks shall not be acceptable as proof of timely mailing. If not 
received on time applications will not be considered for review and 
will be returned to the applicant. (Applicants should note that the 
U.S. Postal Service does not uniformly provide dated postmarks. Before 
relying on this method, applicants should check with their local post 
office). Please do not send applications to the National Institutes of 
Health (NIH). Any application sent to NIH that is forwarded to FDA's 
Grants Management Office and not received in time for orderly 
processing will be judged nonresponsive and returned to the applicant. 
Applications must be submitted via U.S. mail or commercial carrier or 
hand delivered as stated previously in this document.
    Applications submitted electronically must be received by close of 
business on the published receipt date.
    No addendum material will be accepted after the receipt date.

4. Intergovernmental Review

    The regulations issued under Executive Order 12372, 
Intergovernmental Review of Department of Health and Human Services 
Programs and Activities (45 CFR part 100) apply to the Food Safety and 
Security Monitoring Project. Applicants (other than federally 
recognized Indian tribal governments) should contact the State's Single 
Point of Contact (SPOC) as early as possible to alert the SPOC to the 
prospective application(s) and to receive any necessary instructions on 
the State's review process. A current listing of SPOCs is included in 
the application kit or at http://www.whitehouse.gov/omb/grants/spoc.html. (FDA has verified the Web site address, but FDA is not 
responsible for subsequent changes to the Web site after this document 
publishes in the Federal Register.) The SPOC should send any State 
review process recommendations to the FDA administrative contact (see 
Addresses to Request Application in section IV 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 not 
guarantee to accommodate or explain SPOC comments that are received 
after the 60-day cutoff.

5. 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.

6. Other Submission Requirements

A. CCR
    In anticipation of the Grants.gov electronic application process 
applicants are encouraged to 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 via the Internet at 
http://www.ccr.gov. (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.) This web site provides a 
CCR handbook with detailed information on data needed prior to 
beginning the online registration, as well as steps to walk applicants 
through the registration process. The applicant must have a DUNS number 
to begin registration. Call Dun & Bradstreet, Inc., at the number 
listed in the previous paragraph of this document if you do not have a 
DUNS number.
    In order to access Grants.gov an applicant will be required to 
register with the Credential Provider. Information about this 
requirement is available at http://www.grants.gov/CredentialProvider. 
(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.)

V. Application Review Information

1. Criteria

A. Scientific/Technical Review Criteria
    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.
    The ad hoc expert panel will review the application based on the 
following scientific and technical merit criteria which will carry 
equal weight:
     The adequacy of facilities, expertise of project staff, 
equipment, support services, commitment to analyze surveillance 
samples, commitment to analyze emergency response samples, and quality 
management practices needed for the project;
     Expertise in the use of GC/MS for the analysis of foods or 
animal tissues;
     Expertise in the use of LC/MS for the analysis of foods or 
animal tissues;
     Expertise in the use of ICP/MS for the analysis of foods 
or animal tissues;
     Expertise in use of ELISA and other antibody-based 
analyses for the identification of toxins in foods or animal tissues;
     Current food or animal tissue analysis programs;
     The rationale and design to meet the goals of the 
cooperative agreement;
     Quality control and quality assurance procedures and 
practices; and
     Abilities and procedures in place to recall personnel and 
establish extended workweeks.

2. Review and Selection Process

A. General Information
    FDA grants management and program staff will review 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. If submitted electronically the 
original signature requirement does not apply.
    If an application is found to be nonresponsive it will be returned 
to the applicant without further consideration. Applicants are strongly 
encouraged to contact FDA to resolve any questions about criteria 
before submitting an application. Please direct all questions of a 
technical or scientific nature to ORA program staff and all questions 
of an administrative or financial nature to the grants management staff 
(see section VII of this document).

[[Page 30125]]

B. Program Review Criteria
    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.
    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 
laboratory sample analysis and testing capacity. Final funding 
decisions will be made by the Commissioner of Food and Drugs (the 
Commissioner) or his designee.
    A responsive application will be reviewed and evaluated for 
scientific and technical merit by an ad hoc panel of experts in the 
subject field of the specific application. Funding decisions will be 
made by the Commissioner or his designee.
    A score will be assigned to each responsive application based on 
the scientific/technical review criteria. The review panel may advise 
the program staff about the appropriateness of the proposal to the 
goals of the ORA/ORO/DFSR cooperative agreement.

3. Anticipated Announcement and Award

    Notification regarding the results of the review in the form of a 
summary statement is anticipated by September 1, 2005. It is 
anticipated that all awards will be made by September 29, 2005.

VI. Award Administration Information

1. Award Notices

    FDA's 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 the applicant by mail or transmitted 
electronically.

2. Administrative and National Policy Requirements

    These agreements will be subject to all policies and requirements 
that govern the research grant programs of PHS, including provisions of 
42 CFR part 52, 45 CFR parts 74 and 92, and the PHS Grants Policy 
Statement.
    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 grant recipients to provide a smoke-
free workplace and to discourage the use of all tobacco products. This 
is consistent with the PHS mission to protect and advance the physical 
and mental health of the American people.
    FDA is committed to achieving the health promotion and disease 
prevention objectives of ``Healthy People 2010,'' a national effort 
designed to reduce morbidity and mortality and to improve quality of 
life. Applicants may obtain a paper copy of the ``Healthy People 2010'' 
objectives, vols. I and II, for $70 ($87.50 foreign) S/N 017-000-00550-
9, by writing to the Superintendent of Documents, P.O. Box 371954, 
Pittsburgh, PA 15250-7954. Telephone orders can be placed to 202-512-
2250. The document is also available in CD-ROM format, S/N 017-001-
00549-5 for $19 ($23.50 foreign) as well as on the Internet at http://www.healthypeople.gov under ``Publications.'' (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.)

3. Reporting

A. Reporting Requirements
    The original and two copies of an 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. Failure to file the 
FSR in a timely fashion will be grounds for suspension or termination 
of the grant. A final FSR will be due 90 days after the expiration of 
the project period as noted on the Notice of Grant Award.
    For continuing cooperative agreements, quarterly reports and an 
annual program progress report are also required. For such cooperative 
agreements, the noncompeting continuation application (PHS 5161-1) will 
be considered the program progress report for the fourth quarter of the 
budget period.
    Quarterly progress reports must contain, but are not limited to the 
following:
    1. A status report on the installation, training, and operational 
readiness of any equipment that is provided;
    2. A summary report on any proficiency testing performed;
    3. A summary status of samples analyzed and time to complete 
individual sample testing; and
    4. A summary description of any other testing performed on the 
equipment.
    A final program progress report, FSR, and invention statement must 
be submitted within 90 days after the expiration of the project period 
as noted on the Notice of Grant Award.
    The final program progress report must provide full written 
documentation of the project, and summaries of laboratory operations, 
as described in the grant application. The documentation must be in a 
form and contain sufficient detail such that other State, local, and 
tribal government FERN laboratories could reproduce the final project.
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 office/grants management 
office and the principal investigator. Periodic site visits with 
officials of the grantee organization may also occur. The results of 
these monitoring activities will be recorded in the official grant file 
and will be available to the grantee upon request consistent with 
applicable disclosure statutes and with FDA disclosure regulations. 
Also, the grantee organization must comply with all special terms and 
conditions of the cooperative agreement, including those which 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 requirements.

VII. Agency Contacts

    Regarding the administrative and financial management aspects of 
this notice: Cynthia Polit (see Addresses to Request Application in 
section IV of this document).
    Regarding the programmatic or technical aspects of this notice: 
Thomas Savage, Division of Field Science, Office of Regulatory Affairs, 
Food and Drug Administration (HFC-140), 5600 Fishers Lane, rm. 12-41, 
Rockville, MD 20857, 301-827-1026, e-mail: [email protected].

VIII. Other Information

    Data included in the application, if restricted with the legend 
specified in this section of the document, may be entitled to 
confidential treatment as trade secret or confidential commercial

[[Page 30126]]

information within the meaning of the Freedom of Information Act and 
FDA's implementing regulations (21 CFR 20.61).
    Unless disclosure is required under the Freedom of Information Act 
as amended (5 U.S.C. 552), as determined by the freedom of information 
officials of the Department of Health and Human Services or by a court, 
data contained in the portions of this application that have been 
specifically identified by page number, paragraph, etc., by the 
applicant as containing restricted information, shall not be used or 
disclosed except for evaluation purposes.

    Dated: May 19, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-10435 Filed 5-20-05; 2:41 pm]
BILLING CODE 4160-01-S