50072 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Notices 

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 


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Drug Administration (FDA) (collectively 

‘‘the Parties’’, or individually as a 

‘‘Party’’) regarding the roles, 

responsibilities, and financial 

commitments of each Party relating to 

the collaboration through working 

groups and steering committees to 

develop strategic plans, set priorities, 

and leverage resources and expertise 

from multiple sources, including the 

private sector, toward the goal of 

facilitating the development of 

nanotechnologies that constitute novel 

research tools and safer, more effective 

cancer therapies by establishing a 

framework for effective risk 

identification, assessment and 

evaluation of emerging products based 

on nanotechnology. This collaboration 

among the Parties will be focused 

primarily on the Nanotechnology 

Characterization Laboratory and directly 

related activities. 

DATES: The agreement became effective 

June 22, 2006. 

FOR FURTHER INFORMATION CONTACT: 

For FDA: Wendy R. Sanhai, Senior 

Scientific Advisor, Office of the 

Commissioner (HF–18), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

7867, FAX: 301–443–9718. 

For NCI: Gregory J. Downing, Director, 

Office of Technology and Industrial 

Relations, Office of the Director, 

National Cancer Institute, 31 Center 

Dr., rm. 10A52, Bethesda, MD 20892, 

301–496–1550, FAX: 301–496–7807. 

For NIST: Debra Kaiser, Chief, Ceramics 

Division, Materials Science and 

Engineering Laboratory, National 

Institute of Standards and 

Technology, 100 Bureau Dr., Stop 

8522, Gaithersburg, MD 20899, 301–

975–6119, FAX: 301–975–5334. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 20.108(c), 

which states that all written agreements 

and MOUs between FDA and others 

shall be published in the Federal 

Register, the agency is publishing notice 

of this MOU. 

Dated: August 16, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

BILLING CODE 4160–01–S 


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[FR Doc. 06–7127 Filed 8–23–06; 8:45 am] 

BILLING CODE 4160–01–C 


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