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https://www.readbyqxmd.com/read/28106360/federal-policy-for-the-protection-of-human-subjects-final-rule
#1
(no author information available yet)
The departments and agencies listed in this document announce revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight...
19, 2017: Federal Register
https://www.readbyqxmd.com/read/28106359/control-of-communicable-diseases-final-rule
#2
(no author information available yet)
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is issuing this final rule (FR) to amend its regulations governing its domestic (interstate) and foreign quarantine regulations to best protect the public health of the United States. These amendments have been made to aid public health responses to outbreaks of new or re-emerging communicable diseases and to accord due process to individuals subject to Federal public health orders. In response to public comment received, the updated provisions in this final rule clarify various safeguards to prevent the importation and spread of communicable diseases affecting human health into the United States and interstate...
19, 2017: Federal Register
https://www.readbyqxmd.com/read/28106358/national-vaccine-injury-compensation-program-revisions-to-the-vaccine-injury-table-final-rule
#3
(no author information available yet)
On July 29, 2015, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) to amend the regulations governing the National Vaccine Injury Compensation Program (VICP or program) by proposing revisions to the Vaccine Injury Table (Table). The Secretary based the Table revisions primarily on the 2012 Institute of Medicine (IOM) report, "Adverse Effects of Vaccines: Evidence and Causality," the work of nine HHS workgroups who reviewed the IOM findings, and consideration of the Advisory Commission on Childhood Vaccines' (ACCV) recommendations...
19, 2017: Federal Register
https://www.readbyqxmd.com/read/28106357/possession-use-and-transfer-of-select-agents-and-toxins-biennial-review-of-the-list-of-select-agents-and-toxins-and-enhanced-biosafety-requirements-final-rule
#4
(no author information available yet)
In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. Following the review, HHS has decided: Not to finalize the proposed changes to the list of select agents and toxins at this time; to finalize provisions to address toxin permissible limits and the inactivation of select agents; to finalize specific provisions to the section of the regulations addressing biosafety; and to clarify regulatory language concerning security, training, incident response, and records...
19, 2017: Federal Register
https://www.readbyqxmd.com/read/28103000/fertility-counseling-and-treatment-for-certain-veterans-and-spouses-interim-final-rule
#5
(no author information available yet)
The Department of Veterans Affairs (VA) amends its regulation regarding fertility counseling and treatment available to certain veterans and spouses. VA currently provides certain infertility services other than in vitro fertilization (IVF) to veterans as part of the medical benefits package. IVF is the process of fertilization by manually fertilizing an egg, and then transferring the embryo to the uterus. This interim final rulemaking adds a new section authorizing IVF for a veteran with a service-connected disability that results in the inability of the veteran to procreate without the use of fertility treatment...
19, 2017: Federal Register
https://www.readbyqxmd.com/read/28102999/recognition-of-tribal-organizations-for-representation-of-va-claimants-final-rule
#6
(no author information available yet)
The Department of Veterans Affairs (VA) is amending its regulations concerning recognition of certain national, State, and regional or local organizations for purposes of VA claims representation. Specifically, this rulemaking allows the Secretary to recognize tribal organizations in a similar manner as the Secretary recognizes State organizations. The final rule allows a tribal organization that is established and funded by one or more tribal governments to be recognized for the purpose of providing assistance on VA benefit claims...
19, 2017: Federal Register
https://www.readbyqxmd.com/read/28102997/confidentiality-of-substance-use-disorder-patient-records-final-rule
#7
(no author information available yet)
The Department of Health and Human Services (HHS) is issuing this final rule to update and modernize the Confidentiality of Alcohol and Drug Abuse Patient Records regulations and facilitate information exchange within new health care models while addressing the legitimate privacy concerns of patients seeking treatment for a substance use disorder. These modifications also help clarify the regulations and reduce unnecessary burden.
18, 2017: Federal Register
https://www.readbyqxmd.com/read/28102996/revisions-to-rules-regarding-the-evaluation-of-medical-evidence-final-rules
#8
(no author information available yet)
We are revising our medical evidence rules. The revisions include redefining several key terms related to evidence, revising our rules about acceptable medical sources (AMS), revising how we consider and articulate our consideration of medical opinions and prior administrative medical findings, revising our rules about medical consultants (MC) and psychological consultants (PC), revising our rules about treating sources, and reorganizing our evidence regulations for ease of use. These revisions conform our rules to the requirements of the Bipartisan Budget Act of 2015 (BBA), reflect changes in the national healthcare workforce and in the manner that individuals receive medical care, and emphasize the need for objective medical evidence in disability and blindness claims...
18, 2017: Federal Register
https://www.readbyqxmd.com/read/28102989/information-and-communication-technology-ict-standards-and-guidelines-final-rule
#9
(no author information available yet)
We, the Architectural and Transportation Barriers Compliance Board (Access Board or Board), are revising and updating, in a single rulemaking, our standards for electronic and information technology developed, procured, maintained, or used by Federal agencies covered by section 508 of the Rehabilitation Act of 1973, as well as our guidelines for telecommunications equipment and customer premises equipment covered by Section 255 of the Communications Act of 1934. The revisions and updates to the section 508-based standards and section 255-based guidelines are intended to ensure that information and communication technology covered by the respective statutes is accessible to and usable by individuals with disabilities...
18, 2017: Federal Register
https://www.readbyqxmd.com/read/28102988/medicaid-program-the-use-of-new-or-increased-pass-through-payments-in-medicaid-managed-care-delivery-systems-final-rule
#10
(no author information available yet)
This rule finalizes changes to the pass-through payment transition periods and the maximum amount of pass-through payments permitted annually during the transition periods under Medicaid managed care contract(s) and rate certification(s). This final rule prevents increases in pass-through payments and the addition of new pass-through payments beyond those in place when the pass-through payment transition periods were established, in the final Medicaid managed care regulations effective July 5, 2016.
18, 2017: Federal Register
https://www.readbyqxmd.com/read/28102986/medical-qualification-determinations-final-rule
#11
(no author information available yet)
The U.S. Office of Personnel Management (OPM) is issuing a final rule to revise its regulations for medical qualification determinations. The revised regulations update references and language; add and modify definitions; clarify coverage and applicability; address the need for medical documentation and medical examination and/or testing for an applicant or employee whose position may or may not have medical standards and/or physical requirements; and recommend the establishment of agency medical review boards...
18, 2017: Federal Register
https://www.readbyqxmd.com/read/28102985/medicare-program-changes-to-the-medicare-claims-and-entitlement-medicare-advantage-organization-determination-and-medicare-prescription-drug-coverage-determination-appeals-procedures-final-rule
#12
(no author information available yet)
This final rule revises the procedures that the Department of Health and Human Services (HHS) follows at the Administrative Law Judge (ALJ) level for appeals of payment and coverage determinations for items and services furnished to Medicare beneficiaries, enrollees in Medicare Advantage (MA) and other Medicare competitive health plans, and enrollees in Medicare prescription drug plans, as well as appeals of Medicare beneficiary enrollment and entitlement determinations, and certain Medicare premium appeals...
17, 2017: Federal Register
https://www.readbyqxmd.com/read/28102984/medicare-and-medicaid-program-conditions-of-participation-for-home-health-agencies-final-rule
#13
(no author information available yet)
This final rule revises the conditions of participation (CoPs) that home health agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. The requirements focus on the care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality care standards, and eliminate unnecessary procedural requirements. These changes are an integral part of our overall effort to achieve broad- based, measurable improvements in the quality of care furnished through the Medicare and Medicaid programs, while at the same time eliminating unnecessary procedural burdens on providers...
13, 2017: Federal Register
https://www.readbyqxmd.com/read/28102983/diseases-associated-with-exposure-to-contaminants-in-the-water-supply-at-camp-lejeune-final-rule
#14
(no author information available yet)
The Department of Veterans Affairs (VA) amends its adjudication regulations regarding presumptive service connection, adding certain diseases associated with contaminants present in the base water supply at U.S. Marine Corps Base Camp Lejeune (Camp Lejeune), North Carolina, from August 1, 1953, to December 31, 1987. This final rule establishes that veterans, former reservists, and former National Guard members, who served at Camp Lejeune for no less than 30 days (consecutive or nonconsecutive) during this period, and who have been diagnosed with any of eight associated diseases, are presumed to have incurred or aggravated the disease in service for purposes of entitlement to VA benefits...
13, 2017: Federal Register
https://www.readbyqxmd.com/read/28102982/requirements-for-notification-evaluation-and-reduction-of-lead-based-paint-hazards-in-federally-owned-residential-property-and-housing-receiving-federal-assistance-response-to-elevated-blood-lead-levels-final-rule
#15
(no author information available yet)
This final rule amends HUD's lead-based paint regulations to reduce blood lead levels in children under age six (6) who reside in federally-owned or -assisted pre-1978 housing, formally adopting a revised definition of "elevated blood lead level" (EBLL) in children under the age of six (6), in accordance with Centers for Disease Control and Prevention (CDC) guidance. It also establishes more comprehensive testing and evaluation procedures for the housing where such children reside. This final rule also addresses certain additional elements of the CDC guidance pertaining to assisted housing and makes technical corrections and clarifications...
13, 2017: Federal Register
https://www.readbyqxmd.com/read/28102981/health-care-programs-fraud-and-abuse-revisions-to-the-office-of-inspector-general-s-exclusion-authorities-final-rule
#16
(no author information available yet)
This final rule amends the regulations relating to exclusion authorities under the authority of the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS or the Department). The final rule incorporates statutory changes, early reinstatement provisions, and policy changes, and clarifies existing regulatory provisions.
12, 2017: Federal Register
https://www.readbyqxmd.com/read/28102980/microbiology-devices-reclassification-of-influenza-virus-antigen-detection-test-systems-intended-for-use-directly-with-clinical-specimens-final-order
#17
(no author information available yet)
The Food and Drug Administration (FDA) is reclassifying antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation.
12, 2017: Federal Register
https://www.readbyqxmd.com/read/28071879/standards-for-accessible-medical-diagnostic-equipment-final-rule
#18
(no author information available yet)
The Architectural and Transportation Barriers Compliance Board (Access Board or Board) is issuing accessibility standards for medical diagnostic equipment. The standards for medical diagnostic equipment (MDE Standards) contain minimum technical criteria to ensure that medical diagnostic equipment, including but not limited to, examination tables, examination chairs, weight scales, mammography equipment, and other imaging equipment used by health care providers for diagnostic purposes are accessible to, and usable by, individuals with disabilities...
9, 2017: Federal Register
https://www.readbyqxmd.com/read/28071878/occupational-exposure-to-beryllium-final-rule
#19
(no author information available yet)
The Occupational Safety and Health Administration (OSHA) is amending its existing standards for occupational exposure to beryllium and beryllium compounds. OSHA has determined that employees exposed to beryllium at the previous permissible exposure limits face a significant risk of material impairment to their health. The evidence in the record for this rulemaking indicates that workers exposed to beryllium are at increased risk of developing chronic beryllium disease and lung cancer. This final rule establishes new permissible exposure limits of 0...
9, 2017: Federal Register
https://www.readbyqxmd.com/read/28071877/clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-devices-or-combination-products-amendments-to-regulations-regarding-intended-uses-final-rule
#20
(no author information available yet)
The Food and Drug Administration (FDA) is issuing this final rule to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion.
9, 2017: Federal Register
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