Department of Health and Human Services May 12, 2011 – Federal Register Recent Federal Regulation Documents

A proposal to certify Kluyveromyces lactis as a host-vector 1 system has been reviewed by the NIH Recombinant DNA Advisory Committee (RAC) and approved by the NIH Director. This decision is based upon the determination that the K. lactis host-vector 1 system affords a moderate degree of biological containment equal to other certified host-vector 1 systems presently listed in the NIH Guidelines. Moreover, it has been determined that certain research with this host-vector system does not present a significant risk to health and the environment and therefore will be exempt from the NIH Guidelines (See Section III-F-6 and Appendix C). Appendix C has been modified to indicate the nature of the research that is exempt when performed in a K. lactis certified host-vector 1 system. In addition, the Office of Biotechnology Activities is updating Appendix D of the NIH Guidelines to include additional lines of experimentation approved by the NIH Director; in this case an experiment involving the introduction of tetracycline resistance into Chlamydia trachomatis that falls under Section III-A-1-a of the NIH Guidelines.

The Health Resources and Services Administration, HIV/AIDS Bureau (HAB) Policy Notice 99-02 established policies for the use of Ryan White HIV/AIDS Program funds authorized under Title XXVI of the Public Health Service (PHS) Act, for housing referral services and short-term or emergency housing needs. Amendment 1 to Policy Notice 99-02, effective March 27, 2008, modified Policy Notice 99-02 by imposing a 24-month cumulative cap on short-term and emergency housing assistance. The limit on benefits would have taken effect on March 27, 2010, and would have impacted individuals who were users of the funds for housing assistance. HRSA received comments from the public concerning the potential impact of the cap and the threat to the ability of clients receiving Ryan White HIV/AIDS Program funded services to receive housing services. In response, HRSA's Administrator directed that Policy Notice 99-02 Amendment 1 be rescinded, as published in the February 10, 2010, Federal Register notice, Volume 75, Issue 27, pages 6672-6673. In addition, the notice indicated that HRSA was conducting a comprehensive review of the Housing Policy. As a result of a thorough vetting and comprehensive review, HRSA is issuing a final notice of Housing Policy Notice 11-01 which replaces HAB Policy Notice 99-02, effective May 12, 2011.