[Federal Register Volume 71, Number 164 (Thursday, August 24, 2006)]
[Notices]
[Pages 50068-50072]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-7124]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Food Safety and Security Monitoring Project--Radiological Health; 
Announcement Type: Cooperative Agreements Under a Limited Competition; 
Funding Opportunity Number: Request for Applications: RFA-FDA-ORA-2006-
4; Catalog of Federal Domestic Assistance Number: 93.448

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), is 
announcing the availability of cooperative agreements for equipment, 
supplies, personnel, training, and facility upgrades to Food Emergency 
Response Laboratory Network (FERN) radiological 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 radiological terrorism or other emergency 
situation. These cooperative agreements are also intended to expand 
participation in networks to enhance Federal, State, local, and tribal 
governmental food safety and security efforts.
    The goal of ORA's cooperative agreement program is to complement 
and improve State, local and Indian tribal governmental food safety and 
security testing programs. 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, participation in method enhancement activities to extend 
analysis capability, and analysis of surveillance samples. In the event 
of a large-scale radiological terrorism event affecting foods or food 
products, the recipient may be required to perform selected 
radiological 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 beverage products.
    All grant application projects that are developed at State, local, 
and tribal governmental levels must have national application that can 
enhance Federal food safety and security programs. At the discretion of 
the FDA, successful project formats will be made available to 
interested Federal, State, local and tribal government FERN 
laboratories.
    There are two key project areas identified for this effort:
    (1) The use of Gamma Spectrometry analysis for the screening and 
identification of gamma emitting radionuclides in foods; and
    (2) The use of Beta Spectrometry analysis for the screening and 
identification of beta emitting radionuclides 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 93.448.

1. Background

    ORA is the primary inspection and analysis component of FDA/ORA 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 a year; and ORA 
laboratories analyze several thousand samples per year. ORA conducts 
special investigations, 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 to address the increasing threat to food safety and security 
through intentional radiological terrorism events. ORA developed 
radiological 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 radiological terrorism 
events.
    Subtitle A of Title III 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 
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, 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 radiological 
terrorism event affecting foods or food products, the recipient may be 
required to perform selected radiological 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

[[Page 50069]]

water; condiments; and alcoholic beverage products.

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) onsite monitoring, (4) supply of 
equipment, (5) FDA's training on processes, and (6) enhancement and 
extension of analytical methodology.
    FDA will provide specific procedures and protocols for the two 
project areas (see section I of this document) to be used for the 
analysis of collected food samples. 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 needed major equipment delivered to 
the awardee's laboratory. The equipment purchased will remain the 
property of FDA and will be provided to the awarded labs on loan.
    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 radionuclides. 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. Shorter timeframes may 
be sought for special testing such as proficiency tests or special 
assignments.

1. Award Amount

    The total amount of funding available in Fiscal Year (FY) 2006 is 
$500,000. Cooperative agreements will be awarded up to $250,000 in 
total (direct plus indirect) costs per year for up to 2 years. It is 
anticipated that two 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. All major needed equipment will be provided on loan from FDA 
and will not be included in the award amount.

2. Length of Support

    The length of support is 2 years and all applicants must apply for 
the full 2 years of currently projected funding. All applicants must 
provide 2 years worth of budgets and program objectives. The initial 
competitive review and award process will provide all awardees with 1 
year of funding. The second year of funding of noncompetitive 
continuation of support will depend on performance during the preceding 
year and availability of Federal funds.

3. Equipment

    FDA will purchase and have all needed major equipment for the two 
project areas delivered to the awardee's laboratory. The equipment 
purchased by FDA will remain the property of FDA under loan to the 
awardee's laboratory for a specified time period. FDA may terminate the 
loan at any time. The equipment may not be transferred by the awardee's 
laboratory to a third party, and the awardee's laboratory assumes full 
responsibility and liability for any claims that may arise as a result 
of operation of this equipment for the period it is in the possession 
of the awardee's laboratory.

4. Funding Plan

    It is anticipated that FDA will make 2 awards in FY 2006 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 and travel for 
training.

III. Eligibility Information

1. Eligible Applicants

    Due to the sensitive counterterrorism nature of this project it is 
imperative that only state government entities with the regulatory 
authority to conduct onsite inspections be participatory members of 
this cooperative agreement program. This is to ensure that any 
regulatory action and/or laboratory analysis that must be completed in 
an emergent situation can be carried out in the most expeditious 
manner. Therefore, this cooperative agreement program is only available 
to current FERN radiological laboratories that at the time of the 
submission of this application also fall into one of the following 
categories: state laboratories, state regulatory agencies with the 
required lab capacity and university laboratories that are currently 
state adjunct laboratories connected to state laboratory and/or 
regulatory agencies with the required state regulatory authority.
    All grant application projects that are developed for this 
competitive cooperative agreement program 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.

2. Cost Sharing or Matching

    Cost sharing is not required.

3. Other

    This cooperative agreement program is authorized by section 312 of 
the Bioterrorism Act.
    Activities that take place under these cooperative agreements may 
involve agents and toxins subject to requirements under 42 CFR Part 72 
(Interstate Shipment of Etiologic Agents) and Part 73 (Select Agents 
and Toxins). Further, persons participating in these cooperative 
agreements may be required to obtain security clearances. Therefore, 
such persons must be capable of meeting all security requirements.
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 Michelle Caraffa, Grants Management Specialist, Division 
of Contracts and Grants Management (HFA-500), Food and Drug 
Administration, 5600 Fishers Lane,

[[Page 50070]]

Rockville, MD 20857, 301-827-7025, e-mail: 
[email protected]. If the application is hand-carried or 
commercially delivered it should be addressed to 5630 Fishers Lane, rm. 
2129, 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 Michelle Caraffa (see previous paragraph). The 
outside of the mailing package should be labeled ``Response to RFA-FDA-
ORA-2006-4.''
    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 ad hoc expert panel will review the application based on the 
following criteria that each applicant should address in their 
cooperative agreement application.
    1. The rationale and design to meet the goals of the cooperative 
agreement:
    A full description of the prospective project's intended goals and 
objectives and how each will guide a full project plan. This section 
should lay out foundation for the entire program.
    2. Expertise in the use of gamma or beta spectroscopy in the 
analysis of foods or animal tissues: Specifically address and provide 
the qualifications of all personnel that will be assigned to the 
project. Including cv/resumes of key laboratory personnel, which should 
include information on personnel that have experience in gamma and beta 
spectroscopy.
    3. Sample Analysis Commitment: The variety and number of samples 
analyzed in the current food or animal tissue programs. The laboratory 
will be required to analyze surveillance and emergency response food 
samples. Therefore, an estimate of the number of food samples that can 
be analyzed for radionuclides by each project area (i.e., gamma 
spectroscopy, beta spectroscopy), must be submitted. This estimate 
should be for a 2-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.
    4. The adequacy of facilities, support services and quality control 
and quality assurance procedures and practices for food and animal 
tissue analysis. This section should include the following:
     A summary description of procedures in place to monitor 
sample workflow, including the tracking and monitoring of sample 
analyses and a description of the current quality assurance program.
     A discussion of the laboratory's ability to complete and 
report on a given sample analysis within the required 2-week time 
frame.
     The name and address of the laboratory facility where the 
equipment will be installed and the name of the most responsible 
individual of that facility.
     A complete description of the laboratory facility, 
specifically addressing the following information:
    (1) Floor diagrams of the current laboratory;
    (2) A description of the envisaged space, to include a floor-plan 
diagram;
    (3) 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, such as power, water, etc.;
    (4) A detailed description of the proposed facilities upgrade 
including drawings and cost estimates;
    (5) 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;
    (6) Details describing the sample receiving and sample storage 
areas and a description of any existing chain-of-custody procedures;
    (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 included.
    5. Laboratory Management Practices: Abilities and procedures in 
place to recall personnel and establish extended work weeks and 
commitment to analyze emergency response samples. 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 abilities and procedures in place to recall personnel, 
establish extended workweeks, etc.;
     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.

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-2006-4 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 SF 424/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.

3. Submission Dates and Times

    The application receipt date is August 31, 2006.
    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

[[Page 50071]]

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/applicants/get_registered.jsp. (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.
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).
    To be a FERN Radiological laboratory, an applicant institution must 
have an approval letter from the FERN National Program Office approving 
the applicant institution as a FERN Radiological laboratory prior to 
the application receipt date of August 31, 2006.
B. 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 
laboratory sample analysis and testing capacity and capability. Final 
funding decisions will be made by the Commissioner of Food and Drugs or 
his designee.
    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.
    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

    It is anticipated that all awards will be made by September 30, 
2006.

VI. Award Administration Information

1. Award Notices

    FDA'S Grants Management Office will notify applicants who have been 
selected for an award. Awards will

[[Page 50072]]

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 (SF 424/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: Michelle Caraffa (see Addresses to Request Application in 
section IV of this document).
    Regarding the programmatic or technical aspects of this notice: 
Alexandra Cossi, Division of Federal State Relations, Office of 
Regulatory Affairs, Food and Drug Administration (HFC-140), 5600 
Fishers Lane, rm. 12-07, Rockville, MD 20857, 301-827-2899, 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 
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: August 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-7124 Filed 8-21-06; 12:49 pm]
BILLING CODE 4160-01-S