Department of Health and Human Services May 26, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
Announcement of Requirements and Registration for: “Harnessing Insights From Other Disciplines To Advance Drug Abuse and Addiction Research” Challenge
The National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health (NIH), is seeking from the general public ideas on how to adapt specialized knowledge from other disciplines to inform new directions and discoveries in drug abuse and addiction research. With the ``Harnessing insights from other disciplines to advance drug abuse and addiction research'' challenge (the ``Challenge''), NIDA aims to gain insights into new methods or approaches that could transform discovery in order to significantly expand our basic knowledge about drug abuse and addiction processes, accelerate the development of novel and more effective prevention and treatment strategies, and/or enhance our capacity to implement, monitor, and improve upon evidence-based interventions. This Challenge is soliciting written proposals that outline novel approaches to addressing research challenges in the drug use and addiction field by leveraging concepts or technologies from other disciplines. This Challenge is being issued as part of NIDA's strategic planning process for 2016-2020. Winning proposals may be used to guide the development of new research programs within NIDA.
Request From the Interagency Committee on Human Nutrition Research (ICHNR) for Comments on the Draft National Nutrition Research Roadmap 2015-2020: Advancing Nutrition Research To Improve and Sustain Health
The Draft National Nutrition Research Roadmap (NNRR) identifies research priorities for human nutrition and describes the role of ICHNR departments and agencies in addressing those priorities over the next five to ten years. ICHNR seeks input about identified research and resource gaps and opportunities and the short- and long- term initiatives proposed to address them. To review the NNRR, please visit https://prevention.nih.gov/nnrr.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Spousal Influence on Consumer Understanding of and Response to Direct-to-Consumer Prescription Drug Advertisements
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.
Mandatory Guidelines for Federal Workplace Drug Testing Programs
The current version of the Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), effective on October 1, 2010, addresses the role and qualifications of Medical Review Officers (MROs) and HHS approval of entities that certify MROs. Subpart MMedical Review Officer (MRO), Section 13.1(b) of the Mandatory Guidelines, ``Who may serve as an MRO?'' states as follows: ``Nationally recognized entities that certify MROs or subspecialty boards for physicians performing a review of Federal employee drug test results that seek approval by the Secretary must submit their qualifications and a sample examination. Based on an annual objective review of the qualifications and content of the examination, the Secretary shall annually publish a list in the Federal Register of those entities and boards that have been approved.'' HHS has completed its review of entities that certify MROs, in accordance with requests submitted by such entities to HHS. The HHS Secretary approves the following MRO certifying entities that offer MRO certification through examination:
Prospective Grant of Exclusive License: Development of Autologous Tumor Infiltrating Lymphocyte Adoptive Cells for the Treatment of Lung, Breast, Bladder, and HPV-Positive Cancers
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to the current licensee, Lion Biotechnologies, Inc., which is located in Woodland Hills, California to practice the inventions embodied in the following patent applications and applications claiming priority to these applications: 1. U.S. Provisional Patent Application No. 61/237,889, filed August 26, 2009 entitled ``Adoptive cell therapy with young T cells'' (HHS Ref No. E-273-2009/0-US-01); 2. U.S. Patent No. 8,383,099 issued February 26, 2013 entitled ``Adoptive cell therapy with young T cells'' (HHS Ref No. E-273-2009/0- US-02); 3. U.S. Patent Application No. 13/742,541 filed January 16, 2013 entitled ``Adoptive cell therapy with young T cells'' (HHS Ref No. E- 273-2009/0-US-03); 4. U.S. Provisional Patent Application No. 61/466,200 filed March 22, 2011 entitled ``Methods of growing tumor infiltrating lymphocytes in gas-permeable containers'' (HHS Ref No. E-114-2011/0-US-01); 5. PCT Application No. PCT/US2012/029744 filed March 20, 2012 entitled ``Methods of growing tumor infiltrating lymphocytes in gas- permeable containers'' (HHS Ref No. E-114-2011/0-US-01); 6. U.S. Patent Application No. 13/424,646 filed May 20, 2012 entitled ``Methods of growing tumor infiltrating lymphocytes in gas- permeable containers'' (HHS Ref No. E-114-2011/0-US-01); 7. U.S. Provisional Patent Application No. 61/846,161 filed July 15, 2013 entitled ``Methods of Preparing Anti-human Papillomavirus Antigen T Cells'' (HHS Ref No. E-494-2013/0-US-01); 8. PCT Application No. PCT/US2014/046478 filed July 14, 2014 entitled ``Methods of Preparing Anti-human Papillomavirus Antigen T Cells'' (HHS Ref No. E-494-2013/0-PCT-02); 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 the Licensed Patent Rights to develop, manufacture, distribute, sell and use unselected whole autologous tumor infiltrating lymphocyte (TIL) adoptive cell therapy products for the treatment of lung, breast, bladder, and HPV- positive cancers. Specifically excluded from this license are methods of generating or using selected subpopulations of TIL and the use of T cell receptors isolated from TIL.
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