Department of Health and Human Services April 4, 2011 – Federal Register Recent Federal Regulation Documents

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.

To help the Nation achieve national health security and to implement the first quadrennial National Health Security Strategy (NHSS) of the United States of America (2009) and build upon the NHSS Interim Implementation Guide for the National Health Security Strategy of the United States of America (2009) the U.S. Government has drafted a NHSS Biennial Implementation Plan (BIP). This document is intended to describe the priority activities to occur during fiscal years 2011 and 2012 of implementation so that all sectors and segments of the Nation are working collectively and leveraging resources to achieve the same outcomes. The activities include responsible entities. The target audience for the BIP is the Nation (individuals, families, communities including all sectors and governments, states and the Federal Government). Two chapters (and respective appendices) of the draft BIP document which address (1) Strategic Objective 4, Foster Integrated, Scalable Health Care Delivery Systems; and (2) Strategic Objective 6, Promote and Effective Countermeasures Enterprise are submitted for public consideration and comment for a period of 14 calendar days at https:// www.phe.gov/nhss. These chapters are the final two to be provided for public consideration and comment; others were available in July 2010. The Office of the Assistant Secretary of Preparedness and Response (ASPR) within the Department of Health and Human Services (HHS) is submitting this document for public consideration as the lead agency in a broad interagency process to draft the implementation plan.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent for Emergency Research.'' This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in the development, conduct, and oversight of research involving FDA-regulated products (e.g., drugs, biological products, devices) in emergency settings when an exception from the informed consent requirements is requested under the Code of Federal Regulations (CFR). FDA determined that guidance is needed in interpreting and complying with these regulations, particularly in the areas of planning and conducting community consultation and public disclosure activities, and the establishment of informed consent procedures to be used when feasible. The guidance announced in this notice finalizes the draft guidance of the same title, dated July 2006.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Marilyn Mehlmauer, MD for 4 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Dr. Mehlmauer was convicted of a misdemeanor under Federal Law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. Dr. Mehlmauer was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Mehlmauer failed to respond. Dr. Mehlmauer's failure to respond constitutes a waiver of her right to a hearing concerning this action.