50068 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Notices 

FDA based these estimates on 

conversations with industry, trade 

association representatives, and internal 

FDA estimates. Once an organization is 

accredited, it will not be required to 

reapply. 

Dated: August 18, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E6–14056 Filed 8–23–06; 8:45 am] 

BILLING CODE 4160–01–S 

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. 

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 


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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, 


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Rockville, MD 20857, 301–827–7025, email: michelle.caraffa@fda.hhs.gov. 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-ofcustody 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 


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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 


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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: 

alexandra.cossi@fda.hhs.gov. 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[FDA 225–06–8403] 

Memorandum of Understanding 

Between the U.S. Food and Drug 

Administration, the National Cancer 

Institute, and the National Institute of 

Standards and Technology 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The purpose of this 

Memorandum of Understanding (MOU) 

is to set forth an agreement between the 

National Cancer Institute (NCI), the 

National Institute of Standards and 

Technology (NIST), and the Food and 


rmajette on PROD1PC67 with NOTICES1