Department of Health and Human Services February 17, 2016 – Federal Register Recent Federal Regulation Documents

The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, announces the availability of draft procedures pertaining to classifications referred to the NIOSH Respiratory Health Division (RHD) by the Department of Labor, Office of Workers' Compensation Programs, for quality assurance review and corrective measures. The draft, titled, National Institute for Occupational Safety and Health (NIOSH) Quality Assurance Review of B Readers' Classifications Submitted in the Department of Labor (DOL) Black Lung Benefits Program, is available for public comment. To view the notice and related materials, visit www.regulations.gov and enter CDC-2016-0020 in the field and click ``Search.'' This draft document does not have the force or effect of the law.

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), at the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to Altra Tech, Ltd. (``AltraTech''), a company incorporated under the laws of the Ireland, having an office in Shannon, Ireland, an exclusive patent commercialization license to practice the following inventions embodied in the following patent applications: US Provisional Patent Application No.60/846,354, entitled, ``(S,S)-trans- 1,2-cyclopentane Diamine-modified and Gamma-lysine-modified Peptide Nucleic Acids as Probes for Nucleic Acid Detection: Synthesis and Applications,'' filed 22 Sep 2006 [HHS Ref No. E-308-2006/0-US-01]; US Provisional Patent Application No. 60/896,667, entitled, ``Synthesis of Trans-tert-butyl-2-aminocyclopentylcarbamate,'' filed 23 Mar 2007 [HHS Ref No. E-308-2006/1-US-01]; International Application PCT/US2007/ 020466, entitled, ``Synthesis of Trans-tert-butyl-2- aminocyclopentylcarbamate,'' filed 21 Sep 2007 [HHS Ref No. E-308-2006/ 2-PCT-01]; US Patent Application No. 12/441,925, filed 21 Sep 2007, [HHS Ref No. E-308-2006/2-US-02]; US Patent Application No. 12/409,159, entitled, ``Cross-Coupled Peptide Nucleic Acids for Detection of Nucleic Acids of Pathogens,'' filed 23 Mar 2009 [HHS Ref No. E-308- 2006/3-US-01]; US Patent No. 9,156,778, entitled, ``Cross-Coupled Peptide Nucleic Acids for Detection of Nucleic Acids of Pathogens,'' issued 13 Oct 2015 [HHS Ref No. E-308-2006/3-US-02]; US Provisional Patent Application No. 61/684,354, entitled, Cyclopentane-peptide Nucleic Acids for Qualitative and Quantitative Detection of Nucleic Acids,'' filed 17 Aug 2012 [HHS Ref No. E-260-2012/0-US-01]; International Application PCT/US2013/055252, filed 16 Aug 2013 [HHS Ref No. E-260-2012/0-PCT-02]; European Patent Application No. 13753962.3, filed 11 Feb 2015, [HHS Ref No E-260-2012/0-EP-03]; Korea Patent Application No. 10-2015-7006286, filed 11 Mar 2015, [HHS Ref No E-260- 2012/0-KR-04]; US Patent Application No. 14/421,732, filed 13 Feb 2015, [HHS Ref No E-260-2012/0-US-05]; US Provisional Patent Application No. 61/333,442, filed 11 May 2010, [HHS Ref No E-129-2010/0-US-01]; International Patent Application No. PCT/US2011/036090, filed 11 May 2011, [HHS Ref No. E-129-2010/0-PCT-02]; European Patent Application No. 11721899.0, filed 11 May 2011, [HHS Ref No. E-129-2010/0-EP-03]; and US Patent Application No. 13/697,123, filed 9 Nov 2012, [HHS Ref No. E-129-2010/0-US-04]. The patent rights in these inventions have been assigned to the United States of America. AltraTech is seeking a worldwide territory for this license. The field of use may be limited to exclusive use of the licensed patent rights limited to the development and sale of trans-cyclopentane-modified peptide nucleic acids (PNA) in a diagnostic test system incorporating AltraTech's proprietary sample preparation and AltraTech's proprietary semiconductor sensor technology for the detection of infectious diseases or pathogenic agents including viruses and microorganisms.

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Point of Care Prothrombin Time/ International Normalized Ratio Devices for Monitoring Warfarin Therapy.'' The purpose of this workshop is to discuss and receive input from stakeholders regarding approaches to the analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio (PT/INR) in vitro diagnostic devices for improved clinical management of warfarin therapy in addition to describing the FDA's process for facilitating the development of safe and effective POC and patient self-testing PT/INR devices. The goal of the workshop is to seek and identify potential solutions to address the scientific and regulatory challenges associated with POC PT/INR devices to ensure safety and effectiveness. The public workshop on ``Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy'' that had been scheduled for January 25, 2016, was postponed due to unanticipated weather conditions and rescheduled for March 18, 2016.

The Center for Tobacco Products (CTP) in the Food and Drug Administration (FDA) is soliciting applications from regulated tobacco product manufacturers to participate in a voluntary pilot program to help CTP evaluate a potential new portal, the CTP eSubmissions Portal (CTP Portal), that is being designed to improve the process in connection with providing certain regulatory submissions electronically to CTP. CTP plans to accept up to six participants for the pilot program. The pilot program is intended to provide CTP regulatory review staff with an opportunity to evaluate the CTP Portal, including its capability for sending and receiving secure messages and providing information as to the documents submitted to it (for example, receipt date and tracking number).

The Administration for Children and Families, Administration for Native Americans (ANA), published a notice for public comment in the Federal Register of December 8, 2015, on the proposed adoption of program policies and procedures concerning FY 2016 Funding Opportunity Announcements (FOA). The document contained incorrect information under ``Section D. Changes to Evaluation Criteria for All FOAs (FOA Section V.1. Criteria); 45 CFR 75.204'' concerning evaluation criteria and point values for the Native Youth Initiative for Leadership, Empowerment, and Development (hereinafter referred to as ``Native Youth I-LEAD'') Funding Opportunity Announcement (HHS-2016-ACF-ANA-NC-1167).