Department of Health and Human Services October 29, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications'' dated November 2007. The guidance document is intended to assist manufacturers and sponsors in the development of deoxyribonucleic acid (DNA) vaccines to prevent infectious diseases. The guidance supersedes the guidance document entitled ``Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications'' dated December 1996. In addition, the guidance announced in this notice finalizes the draft guidance of the same title dated February 2005.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Combustion Engineering, Windsor, Connecticut, 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: Combustion Engineering. Location: Windsor, Connecticut. Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1965 through December 31, 1972.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Horizons, Inc., Cleveland, Ohio, 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: Horizons, Inc. Location: Cleveland, Ohio. Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1944 through December 31, 1956; and January 1, 1957 through July 31, 2006 (residual period).

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Westinghouse Atomic Power Development Plant, East Pittsburgh, Pennsylvania, 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: Westinghouse Atomic Power Development Plant. Location: East Pittsburgh, Pennsylvania. Job Titles and/or Job Duties: All testers and laboratory researchers (to include research group leaders who worked in the L Building (and K Building as applicable). Period of Employment: January 1, 1942 through December 31, 1944.