Department of Health and Human Services August 28, 2008 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Spencer Chemical Company/Jayhawk Works near Pittsburg, Kansas, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 15, 2008, the Secretary of HHS designated the following class of employees as an addition to the SEC:

Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. Sec. 300aa-26), the CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. CDC seeks written comment on a proposed new vaccine information statement that consolidates the six vaccine information statements for the following childhood vaccines: DTaP, Haemophilus influenzae type b, inactivated polio vaccine, pneumococcal conjugate vaccine, hepatitis B, and rotavirus. This consolidated Vaccine Information Statement would be available to be used by vaccination providers as an alternative to providing the six individual Vaccine Information Statements for the same vaccines. On October 4, 2007, CDC published a notice in the Federal Register (72 FR 56765) seeking public comments on the proposed consolidated vaccine information materials. The 60 day comment period ended on December 3, 2007. Following review of the comments submitted and consultation as required under the law, CDC has finalized these vaccine information materials. The final materials, and revised instructions for their use and for use of materials for other covered vaccines, are contained in this notice.

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 publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.