Department of Health and Human Services August 29, 2005 – Federal Register Recent Federal Regulation Documents

In accordance with the provisions of Section 127 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Public Law 107-188, (the Bioterrorism Act), this document provides guidelines for State, local, and tribal governments, for the expanded distribution, stockpiling, and utilization of KI in the event of a radioactive iodine release from a commercial nuclear power plant incident. This program would extend coverage from the current ten mile radius up to twenty miles from a commercial nuclear power plant. This document is being published in the Federal Register to permit public input on this expanded coverage from a wider range of interested entities than was accomplished with a previous draft. Respondents are also invited to include comments as to whether or not employing measures of prophylaxis other than KI or continuing reliance upon established preventive measures without expanding the area of KI coverage would render the deployment of this expanded KI distribution unnecessary. Further background follows later in these draft guidelines. If individuals inhale or ingest radioactive iodine, administration of KI, when given prior to or within several hours after exposure, can reduce the risk of thyroid cancer among certain categories of persons. KI does not provide protection from external exposure or contamination with radioactive iodine nor does it provide general protection from other sources of ionizing radiation. The primary protective actions are evacuation of the area near the source of the plume, external decontamination of individuals affected, and preventing potentially contaminated food and milk from reaching consumers. Because radioactive iodine exposure at distances beyond 10 miles is likely to be due to contamination of the food and water supply, avoiding the consumption of food or water is expected to be the most effective protective measure for persons in this zone. The Federal Government, through the Nuclear Regulatory Commission, presently makes KI available to States upon their request for distribution to or stockpiling for individuals within 10 miles of a commercial nuclear power plant.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information.'' This draft guidance provides recommendations on what chemistry, manufacturing, and controls information sponsors should include regarding reporting, identification, qualification, and setting acceptance criteria for impurities that are classified as degradation products in drug products when submitting an abbreviated new drug application (ANDA) or supplement to support changes in drug substance synthesis or process, formulation of the drug product, the manufacturing process, or components of the container/closure system.