Department of Health and Human Services May 14, 2013 – Federal Register Recent Federal Regulation Documents
Results 1 - 26 of 26
Zentox Corporation; Withdrawal of Food Additive Petition
The Food and Drug Administration (FDA or we) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 8A4775) proposing that the food additive regulations be amended to provide for the safe use of monochloramine as an antimicrobial agent in poultry process chiller water.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; OAA Title III-C Evaluation
The Administration for Community Living (formerly 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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prescription Drug Product Labeling; Medication Guide Requirements
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Prescription Drug Product Labeling; Medication Guide Requirements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Communicating Composite Scores in Direct-to-Consumer Advertising
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and FDA staff entitled ``Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data.'' The guidance is intended to describe best practices pertaining to conducting and documenting pharmacoepidemiologic safety studies that use electronic healthcare data. The guidance includes recommendations for documenting the design, analysis, and results of such studies to optimize FDA's review of protocols and final reports that are submitted to the Agency.
Prospective Grant of Exclusive License: Device and System for Expression Microdissection (xMD)
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 a start-up exclusive commercial license agreement to practice the inventions embodied in International PCT Application S/N PCT/US03/23317 (HHS Ref. No. E-113-2003/0-PCT-02) filed July 23, 2003, which published as WO 2004/068104 on August 12, 2004, now expired; U.S. Patent No. 7,709,047 (HHS Ref. No. E-113-2003/0-US-03) issued May 4, 2010; U.S. Patent Application S/N 12/753,566 (HHS Ref. No. E-113-2003/0-US-07) filed April 2, 2010; U.S. Patent No. 7,695,752 (HHS Ref. No. E-113- 2003/1-US-01) issued April 13, 2010; U.S. Patent Application S/N 12/ 713,105 (HHS Ref. No. E-113-2003/1-US-02) filed February 25, 2010; Australian Patent No. 2003256803 (HHS Ref. No. E-113-2003/0-AU-04) issued January 21, 2010; Australian Patent Application S/N 2009250964 (HHS Ref. No. E-113-2003/0-AU-06) filed July 23, 2009; and Canadian Patent Application S/N 2513646 (HHS Ref. No. E-113-2003/0-CA-05) filed July 23, 2003, all entitled; ``Target Activated Microtransfer;'' and all continuing applications and foreign counterparts to xMD Diagnostics, LLC, a company having a place of business in Maryland. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive license territory may be ``worldwide'', and the field of use may be limited to the following below. ``Devices, systems, kits and related consumables, and methods using devices, systems, kits and related consumables, for micro-dissection of biological specimens, as covered by the Licensed Patents Rights (the ``Exclusive Field''). xMD Diagnostics, LLC (xMD) shall be the only entity granted rights in the Exclusive Field for commercial or other ``for-profit purposes. Methods, kits, and related consumables that are used independent of the devices or systems by individual researchers employed at non-profit and academic institutions, if such kits were built by the researchers themselves from component parts and used for their own individual research purposes, shall not infringe xMD's rights. Diagnostic services performed using devices, systems, kits and related consumables purchased from xMD (or xMD's authorized distributor(s)) by those persons employed at non-profit and academic institutions that purchased the devices, systems, kits and related consumables used in the diagnostic services, shall not infringe xMD's rights.''
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