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https://www.readbyqxmd.com/read/29611544/findings-of-research-misconduct
#1
COMMENT
(no author information available yet)
No abstract text is available yet for this article.
March 22, 2018: Federal Register
https://www.readbyqxmd.com/read/29493659/findings-of-research-misconduct
#2
COMMENT
(no author information available yet)
No abstract text is available yet for this article.
February 23, 2018: Federal Register
https://www.readbyqxmd.com/read/29461023/schedules-of-controlled-substances-extension-of-temporary-placement-of-mab%C3%A2-chminaca-in-schedule-i-of-the-controlled-substances-act-temporary-rule-temporary-scheduling-order-extension
#3
(no author information available yet)
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of a synthetic cannabinoid, N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (other names: MAB-CHMINACA; ADB-CHMINACA), including its optical, positional and geometric isomers, salts, and salts of isomers. The schedule I status of MAB-CHMINACA currently is in effect through February 4, 2018. This temporary order will extend the temporary scheduling of MAB-CHMINACA for one year, or until the permanent scheduling action for this substance is completed, whichever occurs first...
January 30, 2018: Federal Register
https://www.readbyqxmd.com/read/29461022/medicare-medicaid-and-children-s-health-insurance-programs-announcement-of-the-extension-of-temporary-moratoria-on-enrollment-of-part-b-non-emergency-ground-ambulance-suppliers-and-home-health-agencies-in-designated-geographic-locations-extension-of-temporary
#4
(no author information available yet)
This document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies, subunits, and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, as applicable, to prevent and combat fraud, waste, and abuse. This extension also applies to the enrollment of new non-emergency ground ambulance suppliers and home health agencies, subunits, and branch locations in Medicaid and the Children's Health Insurance Program in those states...
January 30, 2018: Federal Register
https://www.readbyqxmd.com/read/29460613/medical-devices-general-and-plastic-surgery-devices-classification-of-the-surgical-smoke-precipitator-final-order
#5
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the surgical smoke precipitator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the surgical smoke precipitator's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens...
January 30, 2018: Federal Register
https://www.readbyqxmd.com/read/29460606/medical-devices-cardiovascular-devices-classification-of-the-temporary-catheter-for-embolic-protection-during-transcatheter-intracardiac-procedures-final-order
#6
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the temporary catheter for embolic protection during transcatheter intracardiac procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the temporary catheter for embolic protection during transcatheter intracardiac procedures' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
January 30, 2018: Federal Register
https://www.readbyqxmd.com/read/29372981/removal-of-certain-time-of-inspection-and-duties-of-inspector-regulations-for-biological-products-direct-final-rule
#7
(no author information available yet)
The Food and Drug Administration (FDA, Agency, or we) is amending the general biologics regulations relating to time of inspection requirements and also removing duties of inspector requirements. FDA is taking this action to remove outdated requirements and accommodate new approaches, such as a risk-based inspection frequency for drug establishments, thereby providing flexibility without diminishing public health protections. This action is part of FDA's implementation of Executive Orders (E.O.s) 13771 and 13777...
January 26, 2018: Federal Register
https://www.readbyqxmd.com/read/29359892/implementation-of-the-provision-of-the-comprehensive-addiction-and-recovery-act-of-2016-relating-to-the-dispensing-of-narcotic-drugs-for-opioid-use-disorder-final-rule
#8
(no author information available yet)
The Comprehensive Addiction and Recovery Act (CARA) of 2016, which became law on July 22, 2016, amended the Controlled Substances Act (CSA) to expand the categories of practitioners who may, under certain conditions on a temporary basis, dispense a narcotic drug in Schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. Separately, the Department of Health and Human Services, by final rule effective August 8, 2016, increased to 275 the maximum number of patients that a practitioner may treat for opioid use disorder without being separately registered under the CSA for that purpose...
January 23, 2018: Federal Register
https://www.readbyqxmd.com/read/29359891/federal-employees-health-benefits-program-removal-of-eligible-and-ineligible-individuals-from-existing-enrollments-final-rule
#9
(no author information available yet)
The United States Office of Personnel Management (OPM) is issuing a final rule amending Federal Employees Health Benefits (FEHB) Program regulations to provide a process for removal of certain identified individuals who are found not to be eligible as family members from FEHB enrollments. This process would apply to individuals for whom there is a failure to provide adequate documentation of eligibility when requested. This action also amends Federal Employees Health Benefits (FEHB) Program regulations to allow certain eligible family members to be removed from existing self and family or self plus one enrollments...
January 23, 2018: Federal Register
https://www.readbyqxmd.com/read/29320139/reimbursement-for-emergency-treatment-interim-final-rule
#10
(no author information available yet)
The Department of Veterans Affairs (VA) revises its regulations concerning payment or reimbursement for emergency treatment for non-service-connected conditions at non-VA facilities to implement the requirements of a recent court decision. Specifically, this rulemaking expands eligibility for payment or reimbursement to include veterans who receive partial payment from a health-plan contract for non-VA emergency treatment and establishes a corresponding reimbursement methodology. This rulemaking also expands the eligibility criteria for veterans to receive payment or reimbursement for emergency transportation associated with the emergency treatment, in order to ensure that veterans are adequately covered when emergency transportation is a necessary part of their non-VA emergency treatment...
January 9, 2018: Federal Register
https://www.readbyqxmd.com/read/29320138/medical-devices-radiology-devices-classification-of-the-absorbable-perirectal-spacer-final-order
#11
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the absorbable perirectal spacer into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the absorbable perirectal spacer's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens...
January 5, 2018: Federal Register
https://www.readbyqxmd.com/read/29319947/schedules-of-controlled-substances-temporary-placement-of-cyclopropyl-fentanyl-in-schedule-i-temporary-amendment-temporary-scheduling-order
#12
(no author information available yet)
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic opioid, -(1-phenethylpiperidin-4-yl)-N-phenylcyclopropanecarboxamide (cyclopropyl fentanyl), and its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers in schedule I. This action is based on a finding by the Administrator that the placement of cyclopropyl fentanyl in schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety...
January 4, 2018: Federal Register
https://www.readbyqxmd.com/read/29319946/medical-devices-hematology-and-pathology-devices-classification-of-a-cervical-intraepithelial-neoplasia-test-system-final-order
#13
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the cervical intraepithelial neoplasia (CIN) test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the CIN test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens...
January 3, 2018: Federal Register
https://www.readbyqxmd.com/read/29319945/medical-devices-general-and-plastic-surgery-devices-classification-of-the-irrigating-wound-retractor-device-final-order
#14
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the irrigating wound retractor device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the irrigating wound retractor device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens...
January 2, 2018: Federal Register
https://www.readbyqxmd.com/read/29319944/medical-devices-hematology-and-pathology-devices-classification-of-the-whole-slide-imaging-system-final-order
#15
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the whole slide imaging system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the whole slide imaging system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens...
January 2, 2018: Federal Register
https://www.readbyqxmd.com/read/29319943/tricare-reimbursement-of-long-term-care-hospitals-and-inpatient-rehabilitation-facilities-final-rule
#16
(no author information available yet)
This final rule establishes reimbursement rates for Long Term Care Hospitals (LTCHs) and Inpatient Rehabilitation Facilities (IRFs) in accordance with the statutory requirement that TRICARE inpatient care "payments shall be determined to the extent practicable in accordance with the same reimbursement rules as apply to payments to providers of services of the same type under Medicare." This final rule adopts Medicare's reimbursement methodologies for inpatient services provided by LTCHs and IRFs. Each reimbursement methodology will be phased in over a 3-year period...
December 29, 2017: Federal Register
https://www.readbyqxmd.com/read/29319942/medical-devices-obstetrical-and-gynecological-devices-classification-of-the-pressure-wedge-for-the-reduction-of-cesarean-delivery-final-order
#17
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the pressure wedge for the reduction of cesarean delivery into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the pressure wedge for the reduction of cesarean delivery's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
December 28, 2017: Federal Register
https://www.readbyqxmd.com/read/29319941/medical-devices-radiology-devices-classification-of-the-rectal-balloon-for-prostate-immobilization-final-order
#18
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the rectal balloon for prostate immobilization into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the rectal balloon for prostate immobilization's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
December 27, 2017: Federal Register
https://www.readbyqxmd.com/read/29319940/medical-devices-neurological-devices-classification-of-the-external-vagal-nerve-stimulator-for-headache-final-order
#19
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the external vagal nerve stimulator for headache into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external vagal nerve stimulator for headache's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
December 27, 2017: Federal Register
https://www.readbyqxmd.com/read/29319939/medical-devices-neurological-devices-classification-of-the-computerized-behavioral-therapy-device-for-psychiatric-disorders-final-order
#20
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the computerized behavioral therapy device for psychiatric disorders into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the computerized behavioral therapy device for psychiatric disorders' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
December 27, 2017: Federal Register
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