Department of Health and Human Services March 10, 2011 – Federal Register Recent Federal Regulation Documents

The NIEHS is updating its strategic plan. To anticipate, meet, and set priorities for environmental health research, training, resources, and technologies, NIEHS requests input from scientists, staff, stakeholders, members of the public, and all interested parties. The goal of this strategic planning process is to define an overarching Vision Statement, Strategic Goals, and Implementation Strategies for the NIEHS. To begin the process, the institute is asking for the online submission of Visionary Ideas. In addition, the NIEHS seeks the nomination of interested individuals to participate in a Stakeholder Community Workshop to identify, discuss, and develop the draft strategic goals that will form the basis of the Strategic Plan. The current NIEHS Strategic Plan can be viewed at: https:// www.niehs.nih.gov/about/od/strategicplan/strategicplan2006/in dex.cfm.

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 issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Mark E. Van Wormer, MD, 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 Dr. Van Wormer was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Dr. Van Wormer was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. In a January 1, 2011, letter to FDA, Dr. Van Wormer notified FDA that he did not plan to seek a hearing and therefore has waived his right to a hearing concerning this action.

On January 5, 2011 HHS/CDC published a Notice of Proposed Rulemaking (NPRM) in the Federal Register (76 FR 678) proposing to amend its regulations (42 CFR 71.53) for the importation of live nonhuman primates (NHPs). Written comments were to be received on or before March 7, 2011. We have received a request asking for a 45 day extension of the comment period. In consideration of that request, HHS/ CDC is extending the comment period by 45 days to April 25, 2011.