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

NICEATM, in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), announces a public meeting of an independent scientific peer review panel (Panel) on alternative ocular safety testing methods. The Panel will evaluate (1) the validation status of a testing strategy that proposes the use of three in vitro test methods to assess the eye irritation potential of antimicrobial cleaning products (AMCPs), (2) the validation status of four in vitro test methods for identifying moderate (EPA Category II, UN Globally Harmonized System of Classification and Labeling of Chemicals (GHS) Category 2A) and mild (EPA Category III, GHS Category 2B) ocular irritants and substances not classified as ocular irritants (EPA Category IV, GHS Not Classified), (3) the validation status of the in vivo Low Volume Eye Test, and (4) a proposal for the routine use of topical anesthetics, systemic analgesics, and humane endpoints to avoid and minimize pain and distress during in vivo ocular irritation testing.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(1), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the invention embodied in United States Patent No. 5,554,603, issued September 10, 1996, entitled ``Orally Active Derivatives of 1, 3, 5(10)-Estratriene'' (HHS Ref. No. E-137-1993/0-US-01); PCT Application No. PCT/US94/10393, filed September 15, 1994, now expired, entitled ``Orally Active Derivatives of 1, 3, 5(10)-Estratriene'' (HHS Ref. No. E-137-1993/0-PCT-02); Australian Patent No. 700576, issued April 22, 1999, entitled ``Orally Active Derivatives of 1, 3, 5(10)-Estratriene'' (HHS Ref. No. E-137- 1993/0-AU-03); Canadian Patent No. 2171740, issued July 26, 2005, entitled ``Orally Active Derivatives of 1, 3, 5(10)-Estratriene'' (HHS Ref. No. E-137-1993/0-CA-04); European Patent No. 719276, issued November 26, 1997, entitled ``Orally Active Derivatives of 1, 3, 5(10)- Estratriene'' (HHS Ref. No. E-137-1993/0-EP-05) and validated in Austria, Switzerland, Germany, Denmark, Spain, France, Greece, Ireland, Italy, Luxembourg, Monaco, the Netherlands, Portugal, Sweden, Belgium, and Great Britain; and Japanese Patent No. 3993228, issued August 3, 2007, entitled ``Orally Active Derivatives of 1, 3, 5(10)-Estratriene'' (HHS Ref. No. E-137-1993/0-JP-06) to Evestra, Inc., having a place of business in San Antonio, Texas. The patent rights in this invention have been assigned to the United States of America.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``CAHPS Field Test of Proposed Health Information Technology Questions and Methodology.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.

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 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.

This notice announces the application of the College of American Pathologists (CAP) for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for all specialties and subspecialties. In this notice, we announce the approval and grant the CAP deeming authority for all CLIA specialties and subspecialties for a period of 6 years. We have determined that the CAP meets or exceeds the applicable CLIA requirements.