Department of Health and Human Services September 3, 2014 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Medical Devices; Hematology and Pathology Devices; Classification of Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization
The Food and Drug Administration (FDA) is classifying early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the early growth response 1 (EGR1) gene fluorescence in-site hybridization (FISH) test system for specimen characterization 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 Transfer of Ownership and Exclusive Use of 510(K) Number K113336 for the CDC DENV-1-4 Real-Time RT-PCR ASSAY
This is notice that the Centers for Disease Control and Prevention, Department of Health and Human Services, is contemplating the transfer of ownership and exclusive use of 510(k) Number K113336 to American Type Culture Collection (ATCC), a District of Columbia non- profit corporation. 510(k) Number K113336 allows marketing of the CDC DENV-1-4 Real-Time RT-PCR Assay, an in vitro molecular diagnostic test that consists of a panel of oligonucleotide primers and dual-labeled hydrolysis (TaqMan[supreg]) probes for the qualitative detection of dengue virus target sequences in serum and plasma using nucleic acid isolation, amplification, and detection on the ABI 7500 Fast Dx Real- Time PCR instrument. The contemplated transfer would occur in conjunction with the grant of a non-exclusive patent license to ATCC to practice the inventions embodied in patent applications under HHS Ref. No E-148-2013/0, including U.S. Provisional Patent Application No. 61/ 554,126, entitled ``Broad Detection of Dengue Virus Serotypes'', filed November 1, 2011.
Delta States Rural Development Network Grant Program
The Office of Rural Health Policy (ORHP) is announcing supplemental awards to the current Delta States Rural Development Network Grant Program (Delta States) grantees. The supplemental funds will allow current Delta grantees to implement outreach and enrollment activities to the rural uninsured in the Mississippi Delta for the next Affordable Care Act's (ACA) Health Insurance Marketplace open enrollment period (November 15, 2014February 15, 2015). In addition, it will help educate the newly insured about the insurance and benefits they can now access as a result of enrolling during the initial Health Insurance Marketplace open enrollment period. The overarching goals of this supplemental funding are to: (1) increase the number of uninsured educated about their coverage options, (2) increase the number of uninsured enrolled into the Health Insurance Marketplaces or other available sources of insurance, such as Medicaid and the Children's Health Insurance Program, and (3) increase the number of newly insured individuals educated about the benefits and primary care and preventative services to which they now have access.
Scientific Information Request on Emerging Approaches To Diagnosis and Treatment of Non-Muscle-Invasive Bladder Cancer
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Emerging Approaches to Diagnosis and Treatment of Non-Muscle-Invasive Bladder Cancer, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information will improve the quality of this review. AHRQ is conducting this systematic review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).
Scientific Information Request on Diagnosis of Gout
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Diagnosis of Gout, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information will improve the quality of this review. AHRQ is conducting this systematic review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).
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