Department of Health and Human Services December 14, 2006 – Federal Register Recent Federal Regulation Documents

Influenza viruses have threatened the health of animal and human populations for centuries. A pandemic occurs when a novel strain of influenza virus emerges that has the ability to infect and be passed between humans. Because humans lack immunity to the new virus, a worldwide epidemic, or pandemic, can ensue. Three human influenza pandemics occurred in the 20th century. In the U.S., each pandemic led to illness in approximately 30 percent of the population and death in between 2 in 100 and 2 in 1,000 of those infected. It is projected that a modern pandemic, absent effective control measures, could result in the deaths of 200,000 to 2 million people in the United States alone. Extensive information on Federal government strategic and implementation plans for pandemic flu is available at https:// www.pandemicflu.gov. A critical part of the United States Government (USG) strategy to control the spread of a pandemic and reduce its health and societal impact is through the use of vaccines. The U. S. Government is working toward a goal of expanding domestic influenza vaccine surge capacity for the production of pandemic influenza vaccines for the entire population within six months of a pandemic declaration. However, at the beginning of a pandemic, the scarcity of pre-pandemic influenza vaccine and pandemic influenza vaccine (which could include up to two doses) will require that the limited supply be prioritized for distribution and administration. Pre-pandemic vaccine refers to influenza vaccine that is produced against a virus strain that is believed to have pandemic potential and is maintained in a national stockpile. Depending on what influenza strain actually causes the pandemic, stockpiled pre- pandemic vaccine may provide some protection. Total quantities of pre- pandemic vaccines will be limited. Accordingly, the Federal government has initiated a process to provide guidance to assist State and local governments, communities, tribal and territorial governments, and the private sector in defining groups that should be considered for priority access to scarce vaccine. Guidance will be drafted by a Federal interagency task force that will seek information and advice from relevant individual stakeholders, a public engagement process in selected communities across the country, and through this Request for Information (RFI). The Federal government plans to issue draft guidance resulting from this process for public comment before finalization. With this RFI, the Department of Health and Human Services (HHS) requests input from the public on considerations in developing guidance for prioritization of the distribution and administration of both pre- pandemic and pandemic influenza vaccines based on various pandemic severity and vaccine supply scenarios. Specifically, HHS is seeking input on pandemic influenza vaccine prioritization considerations from all interested and affected parties, including but not limited to public health and health care individuals and organizations, as well as those from other sectors of the economy including, for example, travel and transportation, commerce and trade, law enforcement, emergency management and responders, other critical infrastructure sectors and the general public. Previous reports relating to pandemic influenza vaccine prioritization issues are available at https:// www.pandemicflu.gov.

This notice announces those sites for which ATSDR has completed public health assessments and health consultations during the period from July 2006 through September 2006. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL) and includes sites for which assessments or consultations were prepared in response to requests from the public.

The Food and Drug Administration (FDA) is proposing to amend its investigational new drug application (IND) regulation concerning charging patients for investigational new drugs. FDA is proposing to revise the current charging regulation to clarify the circumstances in which charging for an investigational drug in a clinical trial is appropriate, to set forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in the agency's proposed rule on expanded access for treatment use of investigational drugs published elsewhere in this issue of the Federal Register, and to clarify what costs can be recovered for an investigational drug. The proposed rule is intended to permit charging for a broader range of investigational and expanded access uses than is explicitly permitted in current regulations.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR Sec. 83.12(e) of a decision to evaluate a petition to designate a class of employees at Dow Chemical Company, Madison, Illinois, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Dow Chemical Company. Location: Madison, Illinois. Job Titles and/or Job Duties: All Atomic Weapons Employer employees who were monitored, or should have been monitored, for exposure to ionizing radiation while working for a number of work days aggregating at least 250 work days, either solely under this employment or in combination with work days within the parameters established for one or more other classes of employees in the Special Exposure Cohort. Period of Employment: January 1, 1957 through December 21, 1960.