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Current Lab News
 

Competitive Bidding Demo Moving Ahead

We have confirmed that the Competitive Bidding Demonstration Project has moved out of OMB to CMS.  According to Linda Lebovic, CMS’s project coordinator for the competitive bidding demo, “OMB has approved the key design elements for the demonstration.  Further operational details are under development within CMS.  We (CMS) will make announcements – including timeline, via the CMS listservs.”

 Additional details will be posted as they become available.

Novel Influenza A Virus Infections Added To Disease Surveillance System 4/11/07

FDA Releases the Guidance for Industry:  Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

The FDA has released the Guidance for Industry:  Eligibility Determination for Donors of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps).  This is the final guidance for both Donor Eligibility Determination and Creutzfeldt-Jacob Disease (CJD).

The announcement of this document release may be found in the Federal Register, Vol. 72, No. 39, Wednesday, February 28, 2007.

A full copy of the Guidance for Industry:  Eligibility Determination for Donors
of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) may be found at http://www.fda.gov/cber/gdlns/tissdonor.pdf or on the CEBR web site http://www.fda.gov/cber/tissue/docs.htm under Guidance and Rules.

Clinical Laboratory Coalition (CLC) letters to Centers for Medicare and Medicaid Services (CMS), 2/8/07

• September 28, 2005
• September 7, 2006
• December 14, 2006

Hold On Medicare Payments, 8-31-06

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