Department of Health and Human Services July 8, 2013 – Federal Register Recent Federal Regulation Documents
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Prospective Grant of Start-Up Exclusive Commercialization License: The Development of a Circularly Permuted IL4-Targeted Pseudomonas Exotoxin A (cpIL4-PE38KDEL) for the Treatment of Cancers and Urological Disorders
This notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 404, indicates that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a start-up exclusive commercialization license to practice the inventions embodied in: (a) Technology families E-047-1994/0 and E-047-1994/1, including U.S. Patent 5,635,599 entitled ``Proteins Comprising Circularly Permuted Ligands'' [HHS Ref. E-047-1994/0-US-01], PCT Application PCT/ US95/04468 entitled ``Circularly Permutated Ligands and Circularly Permuted Chimeric Molecules'' [HHS Ref. E-047-1994/0-PCT-02], European Patent 0754192 entitled ``Proteins Comprising Circularly Permuted Ligand'' [HHS Ref. E-047-1994/0-EP-15, validated in Austria, Belgium, France, Italy, Liechtenstein, The Netherlands, Spain, Switzerland and the United Kingdom], Canadian Patent 2187283 entitled ``Proteins Comprising Circularly Permuted Ligands'' [HHS Ref. E-047-1994/0-CA-14], Australian Patent 694211 entitled ``Proteins Comprising Circularly Permuted Ligands'' [HHS Ref. E-047-1994/0-CA-14], and U.S. Patent 6,011,002 entitled ``Circularly Permutated Ligands and Circularly Permuted Chimeric Molecules'' [HHS Ref. E-047-1994/1-US-01]; (b) Technology family E-021-2010/0, including U.S. Patent Application 61/105,408 entitled ``Targeted Cargo Protein Combination Therapy'' [HHS Ref. E-021-2010/0-US-01] and U.S. Patent Application 12/ 579,281 entitled ``Targeted Cargo Protein Combination Therapy'' [HHS Ref. E-021-2010/0-US-02]; and all related continuing and foreign patents/patent applications for these technology families, to Medicenna Therapeutics, Inc. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective start-up exclusive commercialization license territory may be worldwide, and the field of use may be limited to:
Medicare Program; End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
This rule proposes to update and make revisions to the End- Stage Renal Disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2014. This rule also proposes to set forth requirements for the ESRD quality incentive program (QIP), including for payment year (PY) 2016 and beyond. In addition, this rule proposes to clarify the grandfathering provision related to the 3-year minimum lifetime requirement (MLR) for Durable Medical Equipment (DME). In addition, it provides clarification of the definition of routinely purchased DME. This rule also proposes the implementation of budget- neutral fee schedules for splints and casts, and intraocular lenses (IOLs) inserted in a physician's office. Finally, this rule would make a few technical amendments and corrections to existing regulations related to payment for DMEPOS items and services.
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: ``Pretest of the Ambulatory Surgery/Procedure Survey on Patient Safety Culture Questionnaire (Ambulatory Surgery SOPS).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
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