Department of Health and Human Services May 16, 2013 – Federal Register Recent Federal Regulation Documents

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 information collection requirements for postmarket surveillance of medical devices.

The ``Data Rx: Prescription Drug Abuse Infographic Challenge Concept'' challenges the general public to create an infographic that presents information, rooted in the current research, concerning the growing trend of prescription drug abuse. The infographic should be designed to inform and educate the general public in interesting, novel, and creative ways about the dangers involved with the abuse of prescription drugs.

This document is a request for comment on the revised draft of the Federal Guidelines for Opioid Treatment. These guidelines elaborate upon the Federal opioid treatment standards set forth under 42 CFR part 8.

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 existing reporting requests in CVM Guidance 108, ``How to Register with the CVM Electronic Submission System to Submit Information in Electronic Format using the FDA Electronic Submissions Gateway.''

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.

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 Evaluation Option License Agreement to Advanced Personalized Diagnostics, LLC, a company having a place of business in Alexandria, Virginia, to practice the inventions embodied in U.S. Provisional Patent Application No. 60/976,732, entitled ``Stably Transfected Multicolored Fluorescent Cells'', filed October 1, 2007 (HHS Ref. No. E-281-2007/0-US-01); U.S. Patent Application No. 12/ 060,752, entitled ``Multiplex Assay Method for Mixed Cell Populations'', filed April 1, 2008, (HHS Ref. No. E-281-2007/0-US-02); and U.S. Patent Application No. 12/802,666, entitled ``Methods of Monitoring Angiogenesis and Metastasis in Three Dimensional Co- Cultures'', filed June 10, 2010 (HHS Ref. No. E-281-2007/1-US-01). The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Start-Up Exclusive Evaluation Option License Agreement may be worldwide, and the field of use may be limited to ``The use of the Licensed Patent Rights limited to an FDA-approved Class III in vitro diagnostic device for prediction of therapeutic efficacy in cancer and other angiogenesis-mediated diseases.'' Upon the expiration or termination of the Start-up Exclusive Evaluation Option License Agreement, Advanced Personalized Diagnostics, LLC will have the exclusive right to execute a Start-Up Exclusive Patent License Agreement which will supersede and replace the Start-up Exclusive Evaluation Option License Agreement, with no greater field of use and territory than granted in the Start-up Exclusive Evaluation Option License Agreement.

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: ``Collection of Information for Agency for Healthcare Research and Quality's (AHRQ) Hospital Survey on Patient Safety Culture Comparative Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.