Department of Health and Human Services January 27, 2009 – Federal Register Recent Federal Regulation Documents
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Medicaid Program; Premiums and Cost Sharing
In accordance with the memorandum of January 20, 2009, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Review Plan,'' this action temporarily delays for 60 days the effective date of the final rule entitled ``Medicaid Program; Premiums and Cost Sharing'' (73 FR 71828). The temporary 60-day delay in effective date is necessary to give Department officials the opportunity for further review and consideration of new regulations. In addition, this action reopens the comment period on the policies set out in the November 25, 2008 final rule.
Prospective Grant of Exclusive License: Multi-Domain Amphipathic Helical Peptides for the Treatment of Cardiovascular Diseases
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license worldwide to practice the invention embodied in: United States Provisional Patent Application No. 60/ 619,392, filed October 15, 2004, entitled ``Multi-Domain Amphipathic Helical Peptides and Methods of Their Use'' (HHS Ref. No. E-114-2004/0- US-01), United States Patent Application Serial No. 11/577,259, filed April 13, 2007, entitled ``Multi-Domain Amphipathic Helical Peptides and Methods of Their Use'' (HHS Ref. No. E-114-2004/0-US-07); Australian Patent Application Serial No. 2005295640, filed October 14, 2005, entitled ``Multi-Domain Amphipathic Helical Peptides and Methods of Their Use'' (HHS Ref. No. E-114-2004/0-AU-03); Canadian Patent Application Serial No. 2584048, filed October 14, 2005, entitled ``Multi-Domain Amphipathic Helical Peptides and Methods of Their Use'' (HHS Ref. No. E-114-2004/0-CA-04); European Patent Application Serial No. 05815961.7, filed October 14, 2005, entitled ``Multi-Domain Amphipathic Helical Peptides and Methods of Their Use'' (HHS Ref. No. E-114-2004/0-EP-05); Japanese Patent Application Serial No. 2007- 536912, filed October 14, 2005, entitled ``Multi-Domain Amphipathic Helical Peptides and Methods of Their Use'' (HHS Ref. No. E-114-2004/0- JP-06) to KineMed, Inc., having a place of business in the State of California. The field of use may be limited to FDA or foreign regulatory body approved 5a peptide therapeutic for the prevention and treatment of cardiovascular diseases. The United States of America is the assignee of the patent rights in this invention. The territory may be worldwide. This announcement is the second notice to grant an exclusive license to this technology and supersedes any previous announcements including the Notice published in the Federal Register on Wednesday, May 11, 2005 (70 FR 24832).
Notice of Request for Public To Submit Comments; Extension of Comment Period
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announced the availability of a draft document available for public comment entitled ``NIOSH Criteria Document Update: Occupational Exposure to Hexavalent Chromium'' on October 17, 2008, as well as a public meeting to be held on January 22, 2009. The document and instructions for submitting comments can be found at https:// www.cdc.gov/niosh/review/public/144/. Comments were to be provided to the NIOSH docket by January 31, 2009, as well as given orally at the public meeting. A request has been received to extend the comment period to permit the public more time to gather and submit information. Accordingly, NIOSH is extending the public comment period by 60 days to March 31, 2009.
Solicitation of Written Comments on Draft Centers for Disease Control and Prevention's Immunization Safety Office Scientific Agenda
The Department of Health and Human Services published a document in the Federal Register of January 2, 2009 soliciting comments on the draft Centers for Disease Control and Prevention's Immunization Safety Office Scientific Agenda. Within the instructions for submitting comments electronically there was a typographical error in the e-mail address. The National Vaccine Program Office (NVPO) is requesting resubmission of any public comments sent prior to January 16, 2009 in response to the previously published Request for Information on the Immunization Safety Office Scientific Agenda.
Availability of the Report “ATSDR Studies on Chemical Releases in the Great Lakes Region”
This report responds to a request from the International Joint Commission (IJC), the binational organization that works to implement the Great Lakes Water Quality Agreement (GLWQA) between the U.S. and Canada. The GLWQA calls for the two nations to define ``the threat to human health from critical pollutants'' found in the Great Lakes basin. This notice announces the availability of the report entitled ``ATSDR Studies on Chemical Releases in the Great Lakes Region''. This report summarizes previously-published public health assessment products and chemical release information for the 26 U.S. AOCs and 54 counties that are in close geographic proximity to those AOCs. This is a descriptive report that does not make associations between health outcomes and chemical exposures. The compilation of environmental data, gathered by ATSDR and the Environmental Protection Agency (EPA), is intended to help decision-makers set future priorities.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow information collection related to implementation of the Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to 299b-26, in: ``Patient Safety Organization Certification for Initial Listing and Related Forms and a Patient Safety Confidentiality Complaint Form'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.
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