Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry: Fast Track Drug Development Programs: Designation, Development, and Application Review
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed collection of information concerning requests by sponsors of investigational new drugs and applicants for new drug approvals or biologics licenses for fast track designation as provided in the guidance for industry on fast track drug development programs.
Prospective Grant of Exclusive License: Antibody Therapeutics for the Treatment of Cancer in Humans
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, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the invention embodied in U.S. Patent Application Number 11/895,326, filed August 24, 2007, entitled ``Tumor Markers in Ovarian Cancer'' [E-138-2000/0-US-05]; to Morphotek, Incorporated, having a place of business at Exton, PA. 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 antibodies developed by Licensee's proprietary Human MORPHODOMA[supreg] antibody technology or via humanization for anti-claudin-3 antibody therapeutics for ovarian cancer.
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.
Findings of Scientific Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Lois Bartsch, Ph.D., University of Nebraska Medical Center: Based on the report of an investigation conducted by the University of Nebraska Medical Center (UNMC) and additional analysis conducted by the Office of Research Integrity (ORI) during its oversight review, the U.S. Public Health Service (PHS) found that Lois Bartsch, Ph.D., former postdoctoral research trainee, Department of Genetics, Cell Biology, and Anatomy, UNMC, engaged in scientific misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grants P30 CA36727 and R01 CA77876 and National Center for Research Resources (NCRR), NIH, grant P20 RR016469. Specifically, PHS found that Dr. Bartsch: Falsified DNA sequence files by deleting a nucleotide and changing nucleotide designations and reported the altered file as the ACI rat p16Cdkn2a sequence with a CpG dinucleotide polymorphism in the upstream region to GenBank, in grant application CA118151, and in the poster presented to Cold Spring Harbor Laboratory (CSHL); Fabricated the claim in grant application CA118151 that GenBank entries for the human p16Cdkn2a gene had a CpG polymorphism near the transcription start site; Falsified the differential methylation of CpG dinucleotides near the transcription start site of p16Cdkn2a DNA and reported that tumor tissue was more methylated than normal tissue in ACI rats treated with estrogen and that the ACI allele was more methylated than the BN allele in tumor tissue from (BN x ACI)F1 animals treated with estrogen in grant application CA118151. Dr. Bartsch has entered into a Voluntary Exclusion Agreement (Agreement) in which she neither admits nor denies ORI's finding of scientific misconduct; the settlement is not an admission of liability on the part of the respondent. In accordance with the terms of the Agreement, she has voluntarily agreed, beginning on April 15, 2008: (1) To exclude herself from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as ``covered transactions'' pursuant to HHS' Implementation (2 CFR Part 376 et seq.) of OMB Guidelines to Agencies on Government- wide Debarment and Suspension (2 CFR Part 180) for a period of two (2) years; and (2) To exclude herself permanently from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant or contractor to PHS for a period of three (3) years.
Medicare Program; Changes for Long-Term Care Hospitals Required by Certain Provisions of the Medicare, Medicaid, SCHIP Extension Act of 2007: 3-Year Delay in the Application of Payment Adjustments for Short Stay Outliers and Changes to the Standard Federal Rate
This interim final rule with comment period implements certain provisions of section 114 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 relating to long term care hospitals (LTCHs). These provisions include a 3-year delay in the application of certain provisions of the payment adjustment for short-stay outliers and revisions to the RY 2008 standard Federal rate.