2010-20872. National Cancer Institute's Best Practices for Biospecimen Resources

AGENCY:

National Institutes of Health (NIH), National Cancer Institute (NCI).

ACTION:

Notice with request for comment.

SUMMARY:

As part of the commitment to maintaining current and scientifically accurate best practices, the National Cancer Institute (NCI) is seeking public comment on a revised version of the NCI Best Practices for Biospecimen Resources. This revised version of the NCI Best Practices is intended to both respond to comments received from the biospecimen resource community and provide more current and detailed recommendations related to biospecimen and data quality. Major revisions include the addition of new sections on Biospecimen Resource Management and Operations and Conflict of Interest, expansion of recommendations related to Custodianship and Informed Consent based on NCI workshops, addition of current references throughout the document and harmonization with current federal guidance documents and recommendations from international biospecimen organizations.

DATES:

Effective Date: The updated NCI Best Practices for Biospecimen Resources are open for public comment for a period of 30 days. Comments must be received by September 22, 2010 in order to ensure consideration. After the public comment period has closed, the comments received by NCI will be considered in a timely manner by the NCI Office of Biorepositories and Biospecimen Research. Subsequently, appropriate changes will be made on the Best Practices Web site http://biospecimens.cancer.gov/​bestpractices/​.

ADDRESSES:

Comments submitted via e-mail should use [e-mail] and enter “NCI Best Practices” in the subject line. While NCI prefers that comments be sent by email, NCI will accept written comments. Written comments may be sent to: NCI/OBRR, NIH, 11400 Rockville Pike, Rockwall I Building, Bethesda, MD 20892, Attn: Dr. Nicole Lockhart.

FOR FURTHER INFORMATION CONTACT:

Implementation assistance and inquiries should be directed to senior staff of the relevant NCI Extramural and Intramural Program offices.

SUPPLEMENTARY INFORMATION:

The NCI Best Practices for Biospecimen Research may be found online at http://biospecimens.cancer.gov/​bestpractices/​.

Dated: August 12, 2010.

Douglas R. Lowy,

Deputy Director, National Cancer Institute, National Institutes of Health.