Department of Health and Human Services December 21, 2010 – Federal Register Recent Federal Regulation Documents

This notice announces an administrative hearing to be held on February 10, 2011, at the CMS San Francisco Regional Office, 90 7th Street, 5-300 (5W), San Francisco, California 94103 to reconsider CMS' decision to disapprove California SPAs 08-009A; 08- 009B1; 08-009B2; 08-009D; and 08-019.

The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for MERIDIA (sibutramine hydrochloride (HCl)) oral capsules held by Abbott Laboratories, Inc. (Abbott), 100 Abbott Park Rd., Abbott Park, IL 60064. Abbott has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.

The Food and Drug Administration (FDA) is announcing a tentative schedule of forthcoming meetings of its public advisory committees for 2011. During 1991, at the request of the Commissioner of Food and Drugs (the Commissioner), the Institute of Medicine (the IOM) conducted a study of the use of FDA's advisory committees. In its final report, one of the IOM's recommendations was for the Agency to publish an annual tentative schedule of its meetings in the Federal Register. This publication implements the IOM's recommendation.

The Food and Drug Administration (FDA) is seeking comment on whether to amend the regulations governing good laboratory practices (GLPs). The Agency decided that to require a GLP quality system for all facilities/laboratories, as well as to more completely address nonclinical studies as they are presently conducted, the Agency would need to modify the existing regulations.