Department of Health and Human Services September 29, 2015 – Federal Register Recent Federal Regulation Documents
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Prospective Intent To Grant Start-Up Exclusive Patent License: Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the Public Health Service, Department of Health and Human Services, is contemplating the grant of an exclusive license to Research Think Tank Molecular Diagnostics, Inc. (RTTMDx) having a principal place of business in Georgia, U.S.A., to practice the inventions embodied in U.S. Provisional Patent Application No. 60/ 577,696, filed June 07, 2004, entitled ``Real-Time PCR Point Mutation Assays for Detecting the 103N and 184V Mutations in the Reverse Transcriptase of HIV-1'' (HHS Ref. No. E-198-2013/0-U.S.-01); PCT Application No. PCT/U.S.2005/019907, filed June 07, 2005, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs'' (HHS Ref. No. E-198-2013/0-PCT-02); U.S. Patent Application No. 14/059,085, filed October 21, 2013, entitled ``Real- Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs'' (HHS Ref. No. E-198-2013/0-U.S.-11); U.S. Patent No. 8,043,809, filed December 07, 2006, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs'' (HHS Ref. No. E-198-2013/0-U.S.-07); U.S. Patent No. 8,318,428, filed January 24, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance for Antiviral Drugs'' (HHS Ref. No. E-198- 2013/0-U.S.-08); U.S. Patent No. 8,592,146, filed September 04, 2013, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs'' (HHS Ref. No. E-198-2013/0-U.S.-09); Australian Patent No. 20055252685, issued March 31, 2011, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs,'' (HHS Ref. No. E-198-2013/0-AU-03); Indian Patent No. 19/DELNP/2007, issued December 19, 2013, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-198-2013/0-IN-06); Canadian Patent Application No. 2,891,079, filed May 19, 2015, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-198-2013/0-CA-12); Canadian Patent Application No. 259747, filed December 07, 2006, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-198-2013/0-CA-04); U.S. Provisional Patent Application No. 61/443,926, filed February 17, 2011, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs'' (HHS Ref. No. E-214-2013/0-U.S.-01); PCT Patent Application No. PCT/ U.S.2012/025638, filed February 17, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-214-2013/0-PCT-02); U.S. Application No. 13/ 985,499, filed February 17, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-214-2013/0-U.S.-06); Canadian Patent Application No. 2827324, filed February 17, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-214-2013/0-CA-03); European Patent Application No. 12747199.3, filed February 17, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-214-2013/0-EP-04); Indian Patent Application No. 7110/ DELNP/2013, filed February 17, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-214-2013/0-IN-05); U.S. Provisional Patent Application No. 61/829,473, filed May 31, 2013, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs (HHS Ref. No. E-511-2013/0-U.S.-01); PCT Application No. PCT/U.S.2014/ 040514, filed June 02, 2014, entitled, ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-511-2013/0-PCT-02). 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 Patent License may be worldwide, and the field of use may be limited to ``Development, manufacture, and sale of an FDA-approved or foreign equivalent-approved Class III real-time PCR diagnostic assay for HIV-1 genotyping utilizing whole HIV-1 pol viral sequencing, limited to use in humans.''
Epi-Centers for the Prevention of Healthcare-Associated Infections, Antimicrobial Resistance and Adverse Events
The National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) will be providing a Single Source Competition Supplement to Harvard Pilgrim Healthcare, an awardee of the Epi-Centers for the Prevention of Healthcare-Associated Infections, Antimicrobial Resistance and Adverse Events Cooperative Agreement. The single source supplement will fund research utilizing proprietary methods to improve sepsis prevention by better defining the burden, preventability and identifying measurers to track progress.
Performance Review Board Members
In this notice, the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is publishing the names of the Performance Review Board Members who are reviewing performance for Fiscal Year 2015.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that Xuriden (uridine triacetate), manufactured by Wellstat Therapeutics Corp., meets the criteria for a priority review voucher.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.
E6(R2) Good Clinical Practice; International Conference on Harmonisation; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``E6(R2) Good Clinical Practice.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance amends the guidance entitled ``E6 Good Clinical Practice: Consolidated Guidance'' (E6(R1)) to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, and also updates standards regarding electronic records and essential documents. The draft guidance is intended to improve clinical trial quality and efficiency while maintaining human subject protection. FDA is making this draft guidance available for comment on the sections that are additions to ICH E6(R1) and marked as ``ADDENDUM.''
Determination That ORTHO EVRA (Norelgestromin/Ethinyl Estradiol) Transdermal System, 0.15 Milligrams/24 Hours Norelgestromin and 0.035 Milligrams/24 Hours Ethinyl Estradiol, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that ORTHO EVRA (norelgestromin/ethinyl estradiol) Transdermal System, 0.15 milligrams (mg)/24 hours (hr) norelgestromin and 0.035 mg/24hr ethinyl estradiol was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Controlled Correspondence Related to Generic Drug Development; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Controlled Correspondence Related to Generic Drug Development''. The guidance document provides information regarding the process by which human generic drug manufacturers and related industry can submit correspondence to FDA requesting information on generic drug development. This guidance also describes FDA's process for providing communications related to such correspondence.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
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.
Determination That PONDIMIN (Fenfluramine Hydrochloride) Tablets, 20 Milligrams and 60 Milligrams, and PONDEREX (Fenfluramine Hydrochloride) Capsules, 20 Milligrams Were Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that PONDIMIN (fenfluramine hydrochloride (HCl)) tablets, 20 milligrams (mg) and 60 mg, and PONDEREX (fenfluramine HCl) capsules, 20 mg, were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for fenfluramine HCl tablets, 20 mg or 60 mg, or fenfluramine HCl capsules, 20 mg.
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