Department of Health and Human Services April 29, 2009 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Prospective Grant of Exclusive License: Treating and Preventing Inflammatory Bowel Disease (IBD) Involving Interleukin-13 (IL-13) and Natural Killer T (NKT) Cells
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, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in PCT Patent Application No. PCT/US02/18790, filed June 14, 2002, which published as WO 2004/001655 on December 31, 2003, now expired, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E-131-2002/0-PCT-01];U.S. Patent Application No. 10/517,898, filed December 13, 2004, which was published as US-2006- 0024306 A1 on February 2, 2006, entitled ``A Method of Treating Inflammatory Bowel Disease (IBD)'' [HHS Ref. No. E-131-2002/0-US-02]; European Patent Application No. 02742057.9, filed June 14, 2002, which published as 1552462 on July 13, 2005, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E-131-2002/0-EP-08]; Australian Patent Application No. 2002315115, filed June 14, 2002, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E-131-2002/0-AU- 05]; Japanese Patent Application No. 2004515561, filed June 14, 2002, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E-131-2002/0-JP-04]; New Zealand Patent Application No. 537726, filed June 14, 2002, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E-131-2002/0-NZ-06]; Hong Kong Patent Application No. 05112119.6, filed June 14, 2002, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E- 131-2002/0-HK-09]; South African Patent Application No. 2005/00375, filed June 14, 2002, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E-131-2002/0-ZA- 07]; Canadian Patent Application No. 2489540, filed June 14, 2002, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E-131-2002/0-CA-03]; U.S. Provisional Patent Application No. 60/671,624, filed April 15, 2005, now abandoned, entitled ``Treatment and prevention of IBD using Mutant and Chimeric IL-13 Molecules'' [HHS Ref. No. E-003-2005/0-US-01]; PCT Patent Application No. PCT/US06/014393, filed April 14, 2006, now expired, entitled ``Methods of Treating and Preventing Inflammatory Bowel Disease Involving IL-13 and NKT Cells,'' which published as WO 2006/ 113614 on October 20, 2006 [HHS Ref. No. E-003-2005/0-PCT-02]; European Patent Application No. 06750435.7, filed November 12, 2007, entitled ``Methods of Treating and Preventing Inflammatory Bowel Disease Involving IL-13 and NKT Cells,'' which published as 1877074 on January 16, 2008, [HHS Ref. No. E-003-2005/0-EP-04]; and U.S. Patent Application No. 11/918,711, filed April 14, 2006, entitled ``Treatment and Prevention of Inflammatory Bowel Disease (IBD) Using Mutant and Chimeric IL-13 Molecules'' [HHS Ref. No. E-003-2005/0-US-03] to Innate Immune, Inc. which has an office in Stanford, California, U.S.A. The patent rights in these inventions have been assigned to the United States of America and Brigham and Women's Hospital.
Request for Comment on Minimum Requirements for Criteria in Grant Applications Under the National All Schedules Prescription Electronic Reporting Act of 2005 (NASPER)
This notice is to request comments from interested parties regarding criteria for grants issued under NASPER (42 U.S.C. 280g-3). NASPER establishes a formula grant program for States to establish or improve State controlled substance monitoring systems (``prescription monitoring programs,'' or ``PMPs''). Under NASPER, the Secretary will award grants to qualifying States, defined in the legislation as the 50 States and the District of Columbia (42 U.S.C. 280g-3(i)(8)). This notice is required under NASPER and comments received in response to this notice will be evaluated and as appropriate, included in public announcements for grants under this law.
Prospective Grant of Exclusive License: Dengue Tetravalent Vaccine Containing a Common 30 Nucleotide Deletion in the 3′-UTR of Dengue Types 1,2,3, and 4
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 a an exclusive license to practice the following invention as embodied in the following patent applications: (1) E-120-2001/0, Whitehead et al., ``Development of Mutations Useful for Attenuating Dengue Viruses and Chimeric Dengue Viruses'', Brazilian Patent Application PI0209943.8, filed May 22, 2002, (2) E-089-2002/0,1, Whitehead et al., ``Dengue Tetravalent Vaccine Containing a Common 30 Nucleotide Deletion in the 3'-UTR of Dengue Types 1,2,3, and 4, or Antigenic Chimeric Dengue Viruses 1,2,3, and 4'', Brazilian Patent Application PI0309631-9, filed April 25, 2003, and (3) E-139-2006/0, Whitehead et al., ``Development of Dengue Vaccine Components'', Brazilian Patent Application TBA, filed August 15, 2007 to Fundacao Butantan, having a place of business in Sao Paulo, Brazil. The patent rights in this invention have been assigned to the United States of America.
National Toxicology Program (NTP); Office of Liaison, Policy and Review; Meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM)
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of SACATM on June 25-26, 2009, at the Hilton Arlington Hotel, 950 North Stafford Street, Arlington, VA 22203. The meeting is open to the public with attendance limited only by the space available. SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the NIEHS and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM.
Office of the National Coordinator for Health Information Technology
This notice announces the establishment of the HIT Policy Committee. The American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5), section 13101, directs the establishment of the HIT Policy Committee. The HIT Policy Committee (also referred to as the ``Committee'') is charged with recommending to the National Coordinator a policy framework for the development and adoption of a nationwide health information technology infrastructure that permits the electronic exchange and use of health information as is consistent with the Federal Health IT Strategic Plan and that includes recommendations on the areas in which standards, implementation specifications, and certification criteria are needed. The HIT Policy Committee is also charged with recommending to the National Coordinator an order of priority for the development, harmonization, and recognition of such standards, specifications, and certification criteria.
Office of the National Coordinator for Health Information Technology
This notice announces the establishment of the HIT Standards Committee. The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5), section 13101, directs the establishment of the HIT Standards Committee. The HIT Standards Committee (also referred to as the ``Committee'') is charged with making recommendations to the National Coordinator on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information for purposes of adoption, consistent with the implementation of the Federal Health IT Strategic Plan, and in accordance with policies developed by the HIT Policy Committee.
Updating the List of Hazardous Drugs for the NIOSH Alert: Additions and Deletions to the NIOSH Hazardous Drug List
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft document available for public comment entitled ``Updating the List of Hazardous Drugs for the NIOSH Alert: Additions and Deletions to the NIOSH Hazardous Drug List.'' The document and instructions for submitting comments can be found at https://www.cdc.gov/niosh/review/public/105a/.
Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph
The Food and Drug Administration (FDA) is issuing this final rule to require important new organ-specific warnings and related labeling for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products. The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal anti-inflammatory drugs (NSAIDS). The new labeling is required for all OTC IAAA drug products whether marketed under an OTC drug monograph or an approved new drug application (NDA).
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