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

The Food and Drug Administration (FDA) is announcing the opening of a docket to receive and to make available to the public reports and other relevant information received by FDA related to the Sentinel Initiative. The goal of the Sentinel Initiative is to develop a system that will ultimately enable FDA to actively monitor the safety of marketed regulated products. The information that will be made available is being developed primarily, but not exclusively, as a result of a series of contracts awarded by FDA to inform the development of the system. The information will be made available in the docket under the docket number at the top of this notice, as well as on FDA's Sentinel Initiative Web page (Sentinel Web page) at https:// www.fda.gov/oc/initiatives/advance/sentinel/. FDA welcomes interested parties, including individuals, to submit to this docket their views and perspectives on the information included in the docket or on any other aspect of the Sentinel Initiative.

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.).

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.

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.

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.

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 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.

The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The National Institutes of Health (NIH), an operating division of the Department of Health and Human Services (HHS), has decided, after completion of a Final Environmental Impact Statement (FEIS) and a thorough consideration of the public comments on the Draft EIS and the Final EIS, to implement the Proposed Action, which is identified as the Preferred Alternative in the FEIS. This action involves the establishment of a long-range physical Master Plan for Rocky Mountain Laboratories (RML) in Hamilton, Montana to guide future development of the campus. This alternative accounts for potential growth in RML personnel, possible land acquisitions, and consequent construction of new administrative and research-related space over the 20-year planning period.

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations to clarify the regulatory procedures for notifying the public about the revocation of a biologics license to be consistent with current practices. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.

The Food and Drug Administration (FDA) is correcting a final rule; confirmation of effective date, that appeared in the Federal Register of Friday, April 24, 2009 (74 FR 18626) (the April 24, 2009, final rule; confirmation of effective date). That document had confirmed the effective date of April 27, 2009, for a final rule that published in the Federal Register of April 25, 2008 (73 FR 22720), entitled ``Substances Prohibited From Use in Animal Food or Feed.'' In the April 24, 2009, final rule; confirmation of effective date, the agency also established a compliance date of October 26, 2009, in order to allow additional time for renderers to comply with the new requirements. The April 24, 2009, final rule; confirmation of effective date was published with an inadvertent error in the ``Background'' section. This document corrects that error.