Department of Health and Human Services March 4, 2009 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (DHHS) is reopening the comment period until April 10, 2009 and will hold public meetings concerning the proposed rule for Approval Tests and Standards for Closed-Circuit Escape Respirators that was published in the Federal Register on Wednesday, December 10, 2008.

In 2006, the National Science Advisory Board for Biosecurity, an advisory committee to the Secretary of the Department of Health and Human Services, the NIH Director and all Federal entities that conduct/ support life sciences research published a report entitled ``Addressing Biosecurity Concerns Related to the Synthesis of Select Agents.'' \1\ The report included a recommendation that the United States Government (USG) ``examine the language and implementation of current biosafety guidelines to ensure that such guidelines and regulations provide adequate guidance for working with synthetically derived DNA and are understood by all those working in areas addressed by the guidelines.'' The USG adopted this recommendation and asked NIH to review the NIH Guidelines for Research with Recombinant DNA (NIH Guidelines) to evaluate whether these guidelines need to be revised to address biosafety concerns for research with synthetic DNA. With the advice of the NIH Recombinant DNA Advisory Committee (RAC), which is responsible for advising the NIH Director on all aspects of recombinant DNA technology, including revisions to the NIH Guidelines, the following proposed changes were developed. As outlined in more detail below, the proposed changes will expand the scope of the NIH Guidelines to specifically cover nucleic acid molecules made solely by synthetic means. The changes apply to basic laboratory research and clinical research. In addition, changes were made to clarify the criteria for determining whether an experiment to introduce drug resistance into a microorganism raises important public health issues such that it must be reviewed by the RAC and approved by the NIH Director. Finally, the proposed amendments speak to the appropriate level of review for recombinant or synthetic experiments involving more than half but less than two-thirds of the genome of certain viruses in tissue culture. These changes were prompted by an increased understanding of the biology of certain viruses that demonstrate there may be biosafety risks with certain viruses that contain less than two-thirds of the viral genome.

The Food and Drug Administration (FDA) has determined the regulatory review period for SOLIRIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.

HRSA published the final eligibility guidelines for the Reimbursement of Travel and Subsistence Expenses Program in the Federal Register on October 5, 2007 (72 FR 57049). A subsequent amendment to the Program guidelines was published in the Federal Register on June 20, 2008 (73 FR 35143). HRSA is requesting public comments concerning recommended changes to a specific section of the reimbursement program eligibility guidelines. On page 35145, under the Qualifying Expenses Section, the first paragraph states: