Department of Health and Human Services May 6, 2009 – Federal Register Recent Federal Regulation Documents
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Office of the National Coordinator for Health Information Technology; HIT Policy Committee Meeting
This notice announces the first meeting of the HIT Policy Committee in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; HIT Standards Committee Meeting
This notice announces the first meeting of the HIT Standards Committee in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Compliance Policy Guide; “Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002;” Availability
The Food and Drug Administration (FDA) is announcing the availability of a Compliance Policy Guide (CPG) entitled ``Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.'' The CPG provides written guidance to FDA's and Customs and Border Protection's (CBP's) staff on enforcement of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing regulations, which require prior notice for food imported or offered for import into the United States.
Medicaid Program: Rescission of School-Based Services Final Rule, Outpatient Services Definition Final Rule, and Partial Rescission of Case Management Services Interim Final Rule
This rule proposes to rescind the December 28, 2007 final rule entitled ``Elimination of Reimbursement Under Medicaid for School Administration Expenditures and Costs Related to Transportation of School-Age Children Between Home and School''; the November 7, 2008 final rule entitled ``Clarification of Outpatient Hospital Facility (Including Outpatient Hospital Clinic) Services Definition''; and certain provisions of the December 4, 2007 interim final rule with comment period entitled ``Optional State Plan Case Management Services.'' These regulations have been the subject of Congressional moratoria and have not yet been implemented (or, with respect to case management interim final rule, have only been partially implemented) by CMS. In light of concerns raised about the adverse effects that could result from these regulations, in particular the potential restrictions on services available to beneficiaries, potential deleterious effect on state partners in the economic downturn, and the lack of clear evidence demonstrating that the approaches taken in the regulations are warranted, CMS is proposing to rescind the two final rules in full, and to partially rescind the interim final rule. Rescinding these provisions will permit further opportunity to determine the best approach to further the objectives of the Medicaid program in providing necessary health benefits coverage to needy individuals.
Prospective Grant of Exclusive License: Development of Therapeutics for Use in Humans To Induce Tolerance for Transplantation and To Treat T cell Lymphoma and Leukemia, Autoimmune Diseases Such as Lupus, and Graft-Versus-Host Disease
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent No. 5,167,956 and PCT Application Serial No. PCT/US92/00813 and foreign equivalents thereof, entitled ``Immunotoxin with in vivo T cell suppressant activity and methods of use'' (HHS Ref. No. E-012-1991/0); U.S. Patent No. 5,725,857 and foreign equivalents thereof, entitled ``Immunotoxin with in vivo T cell suppressant activity and methods of use'' (HHS Ref. No. E-012-1991/2); U.S. Patent No. 5,762,927 and foreign equivalents thereof, entitled ``Immunotoxin with in vivo T cell suppressant activity and methods of use'' (HHS Ref. No. E-012-1991/4); Australian Patent No. 762197 and PCT Application Serial No. PCT/US96/ 05087 and other foreign equivalents thereof, entitled ``Methods of inducing immune tolerance using immunotoxins'' (HHS Ref. No. E-012- 1991/5); U.S. Patent No. 6,103,235 and foreign equivalents thereof and U.S. Patent No. 7,125,553 and foreign equivalents thereof, entitled ``Methods of inducing immune tolerance using immunotoxins'' (HHS Ref. No. E-012-1991/7); Australian Patent No. 766692 entitled ``Novel vectors and expression methods for producing mutant proteins'' (HHS Ref. No. E-043-1997/0); U.S. Patent Application No. 10/566,886 and PCT Application No. PCT/US2004/24786 and foreign equivalents thereof entitled ``Methods for expression and purification of immunotoxins'' (E-043-1997/2); U.S. Patent No. 6,632,928 and PCT Application Serial No. PCT/US98/04303 and foreign equivalents thereof, entitled ``Novel immunotoxins and methods of inducing immune tolerance'' (HHS Ref. No. E-044-1997/0); U.S. Patent Application No. 10/296,085 and PCT Application Serial No. PCT/US01/16125 and foreign equivalents thereof entitled ``Immunotoxin Fusion Proteins and Means for Expression Thereof'' (HHS Ref. No. E-044-1997/1); U.S. Patent No. 7,288,254 and PCT Application Serial No. PCT/US99/08606 and foreign equivalents thereof entitled ``Use of immunotoxins to induce immune tolerance to pancreatic islet transplantation'' (HHS Ref. No. E-059-1998/0); Australian Patent No. 781547 and PCT Application No. PCT/US00/10253 and other foreign equivalents thereof, entitled ``Methods related to combined use of immunotoxins and agents that inhibit dendritic cell maturation'' (HHS Ref. No. E-168-1999/0), to Angimmune LLC which is located in Bethesda, Maryland. The patent rights in these inventions have been assigned to the United States of America.
Medicaid Program; Health Care-Related Taxes
This proposed rule would delay enforcement of certain portions of the final rule entitled ``Medicaid Program; Health Care-Related Taxes'' from the expiration of a Congressional moratorium on enforcement on July 1, 2009 until June 30, 2010. That final rule revised the threshold levels under the regulatory indirect guarantee hold harmless arrangement test to reflect the provisions of the Tax Relief and Health Care Act of 2006, amended the definition of the ``class of managed care organization services,'' and removed obsolete transition period regulatory language. These changes would not be affected by this delay of enforcement. The final rule also clarified the standard for determining the existence of a hold harmless arrangement under the positive correlation test, Medicaid payment test, and the guarantee test. This proposed rule would delay enforcement of these latter provisions, concerning hold harmless arrangements, for 1 year.
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.
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.
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) approve the proposed information collection project: ``Understanding Patients' Knowledge and Use of Acetaminophen.'' 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.
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) approve the proposed information collection project: ``Medical Expenditure Panel Survey (MEPS) Household Component and the MEPS Medical Provider Component Through 2012.'' 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.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2010
This proposed rule would update the payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2010 (for discharges occurring on or after October 1, 2009 and on or before September 30, 2010) as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish in the Federal Register on or before the August 1 that precedes the start of each fiscal year, the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups and a description of the methodology and data used in computing the prospective payment rates for that fiscal year.
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