Department of Health and Human Services November 20, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities
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.
Medical Devices; General Hospital and Personal Use Devices; Classification of the Ultraviolet Radiation Chamber Disinfection Device
The Food and Drug Administration (FDA or the Agency) is classifying the ultraviolet (UV) radiation chamber disinfection device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the UV radiation chamber disinfection device classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Prospective Grant of Exclusive License: Development of In Vitro Diagnostics for the Detection of Diseases or Pathogenic Agents
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 Omega Diagnostics Group PLC (``Omega''), a company incorporated under the laws of the United Kingdom, having an office in Alva, Scotland, an exclusive patent 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]; and US Patent Application No. 14/421,732, filed 13 Feb 2015, [HHS Ref No E-260-2012/0-US-05]. The patent rights in these inventions have been assigned to the United States of America. Omega is seeking a worldwide territory for this license. The field of use may be limited to use of the Patent Rights for the development and sale of trans-cyclopentane-modified peptide nucleic acids (PNA) in a diagnostic system incorporating an enzyme-linked immunosorbent assay or Omega's proprietary VISITECT[supreg] technology for the detection of diseases or pathogenic agents including viruses and microorganisms.
Determination That LIPTRUZET (Ezetimibe and Atorvastatin) Tablets, 10 Milligrams/10 Milligrams, 10 Milligrams/20 Milligrams, 10 Milligrams/40 Milligrams, and 10 Milligrams/80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that LIPTRUZET (ezetimibe and atorvastatin) tablets, 10 milligrams (mg)/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ezetimibe and atorvastatin tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, if all other legal and regulatory requirements are met.
Dental Devices; Reclassification of Electrical Salivary Stimulator System
The Food and Drug Administration (FDA) is issuing a final order to reclassify the salivary stimulator system, a postamendments Class III device, into class II (special controls) and to rename the device the ``electrical salivary stimulator system.'' The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Medical Devices; Exemption From Premarket Notification; Class II Devices; Electric Positioning Chair
The Food and Drug Administration (FDA or the Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for electric positioning chair devices. An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. These devices are used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions. This order exempts electric positioning chairs, class II devices, from premarket notification, subject to certain conditions for exemption. This exemption from premarket notification, subject to these conditions (and the limitations in the physical medicine devices limitations of exemptions from premarket notification section of the device regulations), is immediately in effect for electric positioning chairs. FDA is publishing this order in accordance with the exemption from class II premarket notification section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Artificially Sweetened Fruit Jelly and Artificially Sweetened Fruit Preserves and Jams; Revocation of Standards of Identity
The Food and Drug Administration (FDA or we) is revoking the standards of identity for artificially sweetened jelly, preserves, and jams. We are taking this action primarily in response to a citizen petition submitted by the International Jelly and Preserve Association (IJPA). We also are taking this action because these standards are obsolete and unnecessary in light of our regulations for foods named by use of a nutrient content claim and a standardized term. This action will promote honesty and fair dealing in the interest of consumers.
Medicare Program; Request for Information To Aid in the Design and Development of a Survey Regarding Patient and Family Member Experiences With Care Received in Inpatient Rehabilitation Facilities
This request for information will aid in the design and development of a survey regarding patient and family member experiences with the care received in inpatient rehabilitation facilities (IRFs). Comment Date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on January 19, 2016.
Medicare Program; Request for Information To Aid in the Design and Development of a Survey Regarding Patient and Family Member Experiences With Care Received in Long-Term Care Hospitals
This request for information will aid in the design and development of a survey regarding patient and family member experiences with the care received in long-term care hospitals (LTCHs). Comment Date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on January 19, 2016.
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