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topics will be discussed: (1) The 

definition of quality, (2) mechanisms for 

implementing quality in clinical 

investigations, and (3) methods to 

improve the accuracy and reliability of 

collected data. As part of the Human 

Subject Protection/Bioresearch 

Monitoring Initiative (http:// 

www.fda.gov/ oc/ initiatives/ 

criticalpath/), this public workshop 

will help improve the safe conduct of 

clinical investigations and maximize 

efficiency in clinical investigations 

without compromising quality. 

Dated: April 23, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–8137 Filed 4–27–07; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[FDA 225–07–8001] 

Memorandum of Understanding 

Between the National Cancer Institute 

and the Food and Drug Administration 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

notice of a memorandum of 

understanding (MOU) between FDA and 

the National Cancer Institute (NCI), part 

of the National Institutes of Health of 

the Department of Health and Human 

Services. The purpose of this MOU is to 

establish a formal collaboration between 

FDA and NCI regarding proteomics 

science and technology to accelerate 

proteomics technology development 

and application in clinical settings. FDA 

and NCI intend to collaborate in areas 

involving proteomics such as: Sample 

collection, preparation, storage and 

processing; bioinformatics and data 

analysis; discovery and validation of 

biomarkers; and surrogate biomarkers of 

cancer development and drug response, 

including standardization among 

technology platforms and assay 

standards development. 

DATES: The agreement became effective 

April 5, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Francis Kalush, Center for Devices and 

Radiological Health (HFZ–440), Food 

and Drug Administration, 2098 

Gaither Rd., Rockville, MD 20850, 

240–276–0996, e-mail: 

francis.kalush@fda.hhs.gov. 

or Henry Rodriguez, Office of the 

Director, (MSC–2580), National 

Cancer Institute, 31 Center Dr., rm. 

10A52, Bethesda, MD 20892, 301–

496–1550. 

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: April 20, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

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[FR Doc. 07–2106 Filed 4–27–07; 8:45 am] 

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