Department of Health and Human Services September 14, 2006 – Federal Register Recent Federal Regulation Documents
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Prospective Grant of Exclusive License: Use of a Complete T-Cell Receptor Recognizing MART-1 Peptide Restricted by HLA-A2, Incorporated in a Continuous T-Lymphocyte Cell Line Developed or Owned by Licensee To Treat Cancer
This 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 U.S. patent 5,830,755 filed March 27, 1995 [HHS Ref. No. E-093-1995/0-US-01] and Australian Patent 709122 filed March 27, 1996 [HHS Ref. No. E-093- 1995/0-AU-03], entitled T-Cell Receptors and Their Use in Therapeutic and Diagnostic Methods, to CellCure A/S, which is located in Aarhus, Denmark. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of a complete T-cell receptor MART-1 peptide restricted by HLA-A2 incorporated into a continuous T-Lymphocyte cell line developed or owned by licensee to treat cancer.
Office of the National Coordinator for Health Information Technology; American Health Information Community Confidentiality, Privacy, and Security Workgroup Meeting
This notice announces the second meeting of the American Health Information Community (``the Community'') Confidentiality, Privacy, and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.)
Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation; Withdrawal
The Health Resources and Services Administration (HRSA) and the Food and Drug Administration (FDA) published in the Federal Register of May 12, 2006 (71 FR 27606), a direct final rule to amend the regulations to consider as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation; and to exclude such blood vessels from the definition of human cells, tissues, and cellular and tissue-based products. The comment period closed July 26, 2006. HRSA and FDA are withdrawing the direct final rule because FDA received significant adverse comment. The agencies will consider the comments received under our usual procedures for notice and comment in connection with the notice of proposed rulemaking that was published as a companion to the direct final rule (71 FR 27649).
Memorandum of Understanding Between the United States Food and Drug Administration and the National Cancer Institute
The purpose of this Memorandum of Understanding (MOU) is to set forth an agreement between the National Cancer Institute (NCI) and the Food and Drug Administration (FDA) (collectively ``the Parties'', or individually as a ``Party'') to develop and implement the Federal Investigator Registry of Biomedical Information Research Data (FIREBIRD), which will enable clinical investigators, NCI, FDA, and industry entities sponsoring clinical trials of investigational drugs (``Sponsors of Drugs and Biologics'' or ``Sponsors'') to manage clinical investigator information electronically in a fully secure manner.
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