Department of Health and Human Services March 6, 2006 – Federal Register Recent Federal Regulation Documents
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Draft Guidance for Industry: Guide to Minimize Food Safety Hazards of Fresh-Cut Fruits and Vegetables; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables'' (the draft fresh-cut guidance). This document complements FDA's current good manufacturing practices (CGMP) regulations by providing specific guidance on the processing of fresh- cut produce. The draft fresh-cut guidance and the CGMP regulations are intended to assist processors in minimizing microbial food safety hazards common to the processing of most fresh-cut fruits and vegetables sold to consumers in a ready-to-eat form.
Office of the Secretary, Departmental Appeals Board; Privacy Act of 1974; New System of Records
In accordance with the requirements of the Privacy Act, the HHS DAB is publishing a notice of a system of records entitled, ``Medicare Appeals Council Records, HHS/OS/DAB No. 09-90-0048.'' We have provided background information about the proposed system in the SUPPLEMENTARY INFORMATION section below.
Departmental Appeals Board; Privacy Act of 1974; System of Records
On May 19, 1993, in accordance with the requirements of the Privacy Act, the Departmental Appeals Board (DAB) published a notice of a system of records entitled ``Departmental Appeals Board Case and Appeal Records, HHS/OS/DAB No. 09-90-0049.'' 58 FR 29228, May 19, 1993. The DAB has reviewed its May 19, 1993 Privacy Act notice and now proposes to revise that notice. Revisions include the following: Adding routine uses; updating the DAB's address; clarifying its policies and practices for storing, retrieving, accessing, retaining and disposing of records in the system; and making minor editorial or formatting changes. The revised notice, like the original, covers records maintained by the DAB's Appellate Division, Civil Remedies Division, and Alternative Dispute Resolution Division. The DAB's Medicare Appeals Council (MAC) will issue a separate Privacy Act notice describing the system of records used by the MAC and its supporting component, the Medicare Operations Division, to docket, track, manage, and decide appeals and other matters before the MAC.
Government-Owned Inventions; Availability 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.
Government-Owned Inventions; Availability 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.
Prospective Grant of Exclusive License: The Use of IL13-PE38 for the Treatment of Asthma and Pulmonary Fibrosis
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 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 patent license to practice the inventions embodied in U.S. Patent Application No. 60/337,179 filed December 4, 2001, entitled ``IL-13 Receptor-Targeted Immunotoxins Ameliorates Symptoms of Asthma and of Allergy'' [HHS Reference No. E-296-2001/0-US- 01], PCT Application No. PCT/US02/00616 filed February 28, 2002, entitled ``Alleviating Symptoms of TH2-Like Cytokine Mediated Disorders by Reducing IL-13 Receptor-Expressing Cells in the Respiratory Tract'' [HHS Reference No. E-296-2001/0-PCT-02], U.S. Patent Application No. 10/497,804 filed June 4, 2004, entitled ``Alleviating Symptoms of TH2- Like Cytokine Mediated Disorders by Reducing IL-13 Receptor-Expressing Cells in the Respiratory Tract'' [HHS Reference No. E-296-2001/0-US- 03], Australian Patent Application No. 2002258011 filed June 8, 2004, entitled ``Alleviating Symptoms of TH2-Like Cytokine Mediated Disorders by Reducing IL-13 Receptor-Expressing Cells in the Respiratory Tract'' [HHS Reference No. E-296-2001/0-AU-04], Canadian Patent Application No. 2469082 filed February 28, 2002, entitled ``Chimeric Molecule for the Treatment of TH2-Like Cytokine Mediated Disorders'' [HHS Reference No. E-296-2001/0-CA-05], and European Patent Application No. 02727815.9 filed June 29, 2004 entitled ``Alleviating Symptoms of TH2-Like Cytokine Mediated Disorders by Reducing IL-13 Receptor-Expressing Cells in the Respiratory Tract'' [HHS Reference No. E-296-2001/0-EP-06], including background patent rights to U.S. Patent No. 4,892,827, issued on January 9, 1990, entitled ``Recombinant Pseudomonas Exotoxins: Construction of an Active Immunotoxin with Low Side Effects'' [HHS Reference No. E-385-1986/0-US-01], U.S. Patent No. 5,919,456, issued on July 6, 1999, entitled ``IL-13 Receptor Specific Chimeric Proteins'' [HHS Reference No. E-266-1994/0-US-07], U.S. Patent 6,518,061, issued on February 11, 2003, entitled ``IL-13 Receptor Specific Chimeric Proteins and Uses Thereof'' [HHS Reference No. E-266-1994/0-US-08], to NeoPharm, Inc., which has offices in Waukegan, Illinois. The patent rights in these inventions have been assigned and/or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the treatment of asthma and pulmonary fibrosis with IL13-PE38.
Notice of Grant Award to The National Council on the Aging, To Evaluate a Project Entitled, “Cost-Effective and Scalable Strategies for Enrolling Medicare Beneficiaries in Medicare Prescription Drug Extra Help”
The Centers for Medicare and Medicaid Services has awarded a grant entitled, ``Cost-Effective and Scalable Strategies for Enrolling Medicare Beneficiaries in Medicare Prescription Drug Extra Help'' to The National Council on the Aging, 300 D Street, SW., Suite 801, Washington, DC 20024, in response to an unsolicited proposal. The period of performance is March 1, 2006 through February 28, 2007 (Year 1). The applicant proposes to use private-public partnerships to support a five-year strategy of identifying and enrolling eligible beneficiaries through a series of tailored, list-driven intervention approaches already known to be effective in Low-Income Subsidy (LIS) enrollment. The National Council on the Aging (NCOA) is partnering with Benefits Data Trust (BDT) to lead this list-driven intervention research project. They have already received private funds which they plan to award in grants to support test interventions for the proposed study. NCOA expects to test 24-30 intervention approaches over a five- year period. The NCOA team is soliciting CMS cooperation and support to accomplish two objectives critical to the success of the interventions. First, the proposed project will facilitate an ongoing partnership between NCOA and CMS to refine marketing lists by identifying beneficiaries already enrolled in the Medicare Part D Low-Income Subsidy (LIS) or Medicaid. This will allow BDT to create the ``cleanest'' list possible of potential LIS- eligibles. BDT reported that use of similarly refined lists for outreach efforts to low income populations has increased the enrollment success rate, and decreased the cost of enrollment. Secondly, NCOA is seeking CMS funding to evaluate alternative, list-based outreach strategies. NCOA intends to partner with L&M Policy Research for the evaluation of intervention approaches. In addition, NCOA will rely on Bridgespan to be an advisor for cost-effectiveness studies. Evaluation of these approaches could supplement existing market research knowledge, and be useful for quality improvement of ongoing and future beneficiary outreach efforts for LIS.
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