Food Safety and Security Monitoring Project-Radiological Health; Availability of Cooperative Agreements Under a Limited Competition; Request for Applications: FD07-005; Catalog of Federal Domestic Assistance Number: 93.448, 43277-43281 [E7-15061]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 72, Number 149 (Friday, August 3, 2007)]
[Notices]
[Pages 43277-43281]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15061]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Food Safety and Security Monitoring Project--Radiological Health; 
Availability of Cooperative Agreements Under a Limited Competition; 
Request for Applications: FD07-005; 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, 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 situations. These 
cooperative agreements are also intended to expand participation in 
networks to enhance Federal, State, local, and tribal governmental food 
safety and security efforts. This notice supersedes the request for 
applications that published in the Federal Register of August 24, 2006 
(71 FR 50068).

A. Background

    ORA is the primary inspection and analysis component of FDA and has 
approximately 1,600 investigators, inspectors, and analysts who cover 
the country's approximately 95,000 FDA-regulated businesses. These 
investigators inspect more than 15,000 facilities per year and ORA 
laboratories analyze several thousand samples per year. ORA conducts 
special investigations, conducts food inspection recall audits, 
performs consumer complaint inspections, and collects samples of 
regulated products. Increasingly, ORA has been called upon to expand 
the testing program that addresses the increasing threat to food safety 
and security through intentional radiological terrorism events. Toward 
this end, ORA has 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.
    The events of September 11, 2001, reinforced the need to enhance 
the security of the U.S. 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 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.
    FDA will support the projects covered by this document 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.

B. 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, 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 water, condiments, 
and alcoholic products (beer, wine, scotch).

[[Page 43278]]

    All grant application projects that are developed at State, local, 
and tribal governmental 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 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.
    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.

II. Award Information

    Support will be in the form of cooperative agreements. Substantive 
involvement by the awarding agency is inherent in the cooperative 
agreement awards. Accordingly, FDA will have substantial involvement in 
the program activities of the project funded by the cooperative 
agreement. Substantive involvement includes, but is not limited to, the 
following: (1) How often samples will be sent, (2) directions on how 
tests should be executed, (3) onsite monitoring, (4) supply of 
equipment, (5) FDA training on processes, and (6) enhancement and 
extension of analytical methodology.
    FDA will provide specific procedures and protocols for the 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.
    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 facility upgrades, personnel, training, 
and surveillance sample collection.

A. Award Amount

    The total amount of funding available in fiscal year 2007 is 
$750,000. Cooperative agreements will be awarded up to $250,000 in 
total (direct plus indirect) costs per year for up to 3 years. It is 
anticipated that 3 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. Funds may be requested in the budget to travel to FDA for 
meetings with program staff about the progress of the project and to 
travel for training. If the applicant does not have the necessary 
equipment available for these projects, all major needed equipment will 
be provided on loan from FDA and will not be included in the award 
amount.

B. Length of Support

    The length of support is 3 years and all applicants must apply for 
the full 3 years of currently projected funding and program objectives. 
The initial competitive review and award process will provide all 
awardees with 1 year of funding. The second and third year of funding 
of noncompetitive continuation of support will based on performance 
during the preceding year and availability of Federal funds.

C. 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 minimum of 5 years at which point in time it 
may or may not be released as surplus property. 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.

D. Funding Plan

    It is anticipated that FDA will make three awards in fiscal year 
2007 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.

III. Eligibility Information

A. 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 available only 
to current FERN radiological laboratories 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.

B. Cost Sharing or Matching

    Cost sharing is not required.

C. Other

    The entity and/or any or all person(s) involved in any aspect of 
the design, implementation, and/or evaluation of a successful Food 
Safety and Security Monitoring Project--Radiological Health cooperative 
program application may at any time at FDA's discretion be subject to 
requirements under 42 CFR parts 72 and 73 (70 FR 13294, March 18, 
2005), the Bioterrorism Act, and the USA Patriot Act, including but not 
limited to security risk assessments and security clearances.
    Dun & 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

A. Addresses to Request Application

    FDA is only accepting applications for this program electronically 
via Grants.gov by visiting the Web site https://www.grants.gov\1\ and 
following

[[Page 43279]]

the instructions under ``APPLY.'' In order to apply electronically, the 
applicant must have a DUNS number (see section III.C of this document) 
and register in the Central Contractor Registration (CCR) database as 
described in section IV.F of this document.
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    \1\ (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.)
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    The required application, SF424 can be completed and submitted 
online. We strongly encourage using the ``Tips'' posted on https://
www.grants.gov\1\ under the announcement number when preparing your 
submission. If you experience technical difficulties with your online 
submission you should contact either the Grants.gov Customer Response 
Center at https://www.grants.gov/contactus/contactus.jsp\1\ or Michelle 
Caraffa, Food and Drug Administration, 301-827-7025, e-mail: 
michelle.caraffa@fda.hhs.gov.
    To comply with the President's Management Agenda, the Department of 
Health and Human Services (HHS) is participating as a partner in the 
new governmentwide Grants.gov application 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 
Web site. When you enter the Grants.gov Web site, you will find 
information about submitting an application electronically through the 
Web site. In addition, this process is similar to the R01 Grant 
Application process currently used at the National Institutes of 
Health. You can visit the following Web site for helpful background on 
preparing to apply, preparing an application, and submitting an 
application to Grants.gov: https://era.nih.gov/ElectronicReceipt/.\1\
    In unusual circumstances, additional information may be considered, 
on a case-by-case basis, for inclusion in the ad hoc expert panel 
review (see section V.A.2 of this document), however, FDA cannot assure 
inclusion of any information after the receipt date, other than 
evidence of final Institutional Review Board (IRB) approval, Federal-
Wide Assurance (FWA), and certification of adequate supply of study 
product.
    If an application for the same grant was submitted in response to a 
previous request for applications but has not yet been funded, an 
application in response to this document will be considered a request 
to withdraw the previous application. The applicant for a resubmitted 
application should address the issues presented in the summary 
statement from the previous review and include a copy of the summary 
statement itself as part of the resubmitted application.
    The submitted electronic application package is posted under the 
``APPLY'' section for this announcement at https://www.grants.gov.\1\ 
The required application SF424, which is part of the PHS 5161-1 form, 
should be completed and submitted online.

B. Content and Form of Application

1. 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:
    a. 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 a foundation for the entire program.
    b. 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. Curriculum vitae/resumes for key laboratory personnel, 
including information on personnel that have experience in gamma and 
beta spectroscopy, must be provided.
    c. 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 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.
    d. 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:
     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 responsible individual 
at the facility.
     A complete description of the laboratory facility, 
specifically addressing the following information:
    [ctrcir] Floor diagrams of the current laboratory;
    [ctrcir] A description of the envisaged space, to include a floor-
plan diagram;
    [ctrcir] 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.;
    [ctrcir] A detailed description of the proposed facilities upgrade 
including drawings and cost estimates;
    [ctrcir] 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;
    [ctrcir] Details describing the sample receiving and sample storage 
areas and a description of any existing chain-of-custody procedures;
    [ctrcir] 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.
    e. 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 work weeks, etc.; and
     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.

[[Page 43280]]

2. Format for Application
    All applications must be submitted electronically through 
Grants.gov. Paper applications will not be accepted. The application 
must be an SF424. The title of the proposed grant must include the name 
of the product and the investigational drug (IND)/investigational 
device exemption (IDE) number. The narrative portion, excluding 
appendices, of the application may not exceed 100 pages in length and 
must be single-spaced in 12-point font. The appendices should also not 
exceed 100 pages in length (separate from the narrative portion of the 
application).
    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). 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.

C. Submission Dates and Times

    The application receipt date is August 24, 2007. Applications must 
be received by the close of business on the established receipt date. 
Applications not received on time will not be considered for review and 
will generally be returned to the applicant. However, late applications 
may be accepted under extreme circumstances beyond the control of the 
applicant. No addendum material will be accepted after the receipt 
date.

D. Intergovernmental Review

    The regulations issued under Executive Order 12372, 
Intergovernmental Review of Department of Health and Human Services 
Programs and Activities (45 CFR part 100) apply to the Food Safety and 
Security Monitoring Project. Applicants (other than federally 
recognized Indian tribal governments) should contact the State's Single 
Point of Contact (SPOC) as early as possible to alert the SPOC to the 
prospective application(s) and to receive any necessary instructions on 
the State's review process. A current listing of SPOCs is included in 
the application kit or at https://www.whitehouse.gov/omb/grants/
spoc.html.\1\ The SPOC should send any State review process 
recommendations to the FDA administrative contact (see section VII of 
this document). The due date for the State process recommendations is 
no later than 60 days after the application receipt date. FDA does not 
guarantee to accommodate or explain SPOC comments that are received 
after the 60-day cutoff.

E. Funding Restrictions

    These grants are not to fund or conduct food inspections for food 
safety regulatory agencies. They may not be utilized for new building 
construction, however, remodeling of existing facilities is allowed, 
provided that remodeling costs do not exceed 25 percent of the grant 
award amount.

F. Other Submission Requirements

    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 
https://www.ccr.gov.\1\ 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 (see 
section III.C of this document) to begin registration.
    In order to access Grants.gov an applicant will be required to 
register with the Credential Provider. Information about this 
requirement is available at https://www.grants.gov/
CredentialProvider.\1\

V. Application Review Information

A. Criteria

1. General Information
    FDA grants management and program staff will review applications 
sent in response to this document. To be responsive, an application 
must be submitted in accordance with the requirements of this document.
    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 24, 2007.
2. 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 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.
    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 Division of Federal-State Relations cooperative agreement.
3. 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.

B. Anticipated Announcement and Award

    It is anticipated that notification regarding the results of the 
review in the form of a summary statement will be sent to the applicant 
by September 26, 2007. It is anticipated that all awards will be made 
by September 30, 2007.

[[Page 43281]]

VI. Award Administration Information

A. Award Notices

    FDA's grants management office will notify applicants who have been 
selected for an award. A Notice of Grant Award will be signed by the 
FDA Chief Grants Management Officer and be sent to the applicant by 
mail or transmitted electronically.

B. Administrative and National Policy

    Please note as of October 1, 2006, the HHS Grants Policy Statement 
(GPS) (available at https://www.hhs.gov/grantsnet/adminis/gpd/
index.htm\1\) supersedes in its entirety the Public Health Service 
(PHS) GPS, dated April 1, 1994, and addendum dated January 24, 1995.
    Awards issued through this program are subject to the HHS GPS 
requirements that are applicable to you based on the type of 
organization and the purpose of the award. This includes any 
requirements in Parts I and II of the HHS GPS that apply to an award.
    Although consistent with the HHS GPS and applicable statutory and 
regulatory 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 HHS GPS.
    Applicants must adhere to the requirements of this document. 
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 https://
www.healthypeople.gov\1\ under ``Publications.''

C. Reporting

1. 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:
     A status report on the installation, training, and 
operational readiness of any equipment that is provided;
     A summary report on any proficiency testing performed;
     A summary status of samples analyzed and time to complete 
individual sample testing; and
     A summary description of any other testing performed on 
the equipment.
    A final program progress report, final FSR, and a final 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 contain 
sufficient detail such that other State, local, and tribal government 
FERN laboratories could reproduce the final project.
2. 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 administrative and financial management aspects of this 
notice please contact: Michelle Caraffa, Office of Acquisition Support 
and Grants (HFA-500), Food and Drug Administration, 5630 Fishers Lane, 
rm. 2105, Rockville, MD 20857, 301-827-7025, FAX: 301-827-7101, e-mail 
Michelle.Caraffa@FDA.HHS.gov.
    Regarding the programmatic or technical aspects of this notice: 
April D. Kidd, Division of Federal-State Relations (HFC-150), Food and 
Drug Administration, 5600 Fishers Lane, rm. 12-07, Rockville, MD 20857, 
301-827-2913, e-mail: april.kidd@fda.hhs.gov.

VIII. Other Information

    Data included in the application 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 HHS or by a court, data contained in the portions of the 
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: July 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-15061 Filed 8ndash;2-07; 8:45 am]
BILLING CODE 4160-01-S