Department of Health and Human Services February 23, 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Patrick J. Lais from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Mr. Lais was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the act. Mr. Lais has notified FDA that he acquiesces to debarment, and therefore has waived his opportunity for a hearing concerning this action.

The Bureau of Indian Affairs (BIA) and Indian Health Service (IHS) are submitting the information collection, titled ``Indian Self- Determination and Education Assistance Act Programs, 25 CFR 900'' to the Office of Management and Budget for renewal. The current approval, designated by OMB Control Number 1076-0136, expires on February 28, 2010. The information is collected to process contracts, grants, or cooperative agreements for award by the BIA and the IHS, as authorized by the Indian Self-Determination and Education Assistance Act.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) is announcing the opening of a docket to obtain information about current practices and conditions for the production and packing of fresh produce. FDA is establishing this docket in order to provide an opportunity for interested parties to provide information and share views that will inform the development of safety standards for fresh produce at the farm and packing house and strategies and cooperative efforts to ensure compliance.