Department of Health and Human Services November 2016 – Federal Register Recent Federal Regulation Documents

Results 151 - 200 of 300
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-27395
Type: Notice
Date: 2016-11-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed project entitled ``Reframing How We Talk About Alcohol: Public Perceptions of Excessive Alcohol Use Among Multiple Audiences.'' CDC will seek a one-year approval for a new information collection request to assess the public's perceptions and frames regarding alcohol use and its related harms, gain insights on the language the public uses when talking about excessive alcohol use, examine patient-provider communication about alcohol use, and evaluate the influence of other sources of information on the public's understanding of excessive alcohol use.
Medicare Program; CY 2017 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts
Document Number: 2016-27389
Type: Notice
Date: 2016-11-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2017 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2017, the inpatient hospital deductible will be $1,316. The daily coinsurance amounts for CY 2017 will be: (1) $329 for the 61st through 90th day of hospitalization in a benefit period; (2) $658 for lifetime reserve days; and (3) $164.50 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.
Medicare Program; CY 2017 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement
Document Number: 2016-27388
Type: Notice
Date: 2016-11-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2017. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the ``uninsured aged'') and by certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2017, for these individuals will be $413. The premium for certain other individuals as described in this notice will be $227.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2016-27342
Type: Notice
Date: 2016-11-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2016-27341
Type: Notice
Date: 2016-11-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2016-27340
Type: Notice
Date: 2016-11-15
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-27339
Type: Notice
Date: 2016-11-15
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2016-27337
Type: Notice
Date: 2016-11-15
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Center For Scientific Review; Notice of Closed Meeting
Document Number: 2016-27336
Type: Notice
Date: 2016-11-15
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of the Food and Drug Administration's Education at the Point of Sale Campaign
Document Number: 2016-27330
Type: Notice
Date: 2016-11-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the creation of a cohort of cigarette smoking adults between the ages of 25 and 54 for the evaluation of FDA's point of sale tobacco education campaign.
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements
Document Number: 2016-26668
Type: Rule
Date: 2016-11-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This major final rule addresses changes to the physician fee schedule and other Medicare Part B payment policies, such as changes to the Value Modifier, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This final rule also includes changes related to the Medicare Shared Savings Program, requirements for Medicare Advantage Provider Networks, and provides for the release of certain pricing data from Medicare Advantage bids and of data from medical loss ratio reports submitted by Medicare health and drug plans. In addition, this final rule expands the Medicare Diabetes Prevention Program model.
Withdrawal of Two Proposed Rules
Document Number: 2016-27329
Type: Proposed Rule
Date: 2016-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the withdrawal of two proposed rules that published in the Federal Register more than 5 years ago. These proposed rules are no longer considered viable candidates for final action. FDA is taking this action because these proposed rules are out of date.
Announcement of Inaugural Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030
Document Number: 2016-27325
Type: Notice
Date: 2016-11-14
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) announces the first in a series of federal advisory committee meetings regarding the national health promotion and disease prevention objectives for 2030. The first meeting will be held in the Washington, DC metropolitan area. These meetings will be open to the public. The Committee will review the nation's health promotion and disease prevention objectives and accomplishments and will recommend goals and objectives to improve the health status and reduce health risks for Americans by the year 2030. The Committee will advise the Secretary on the Healthy People 2030 mission statement, vision statement, framework, and organizational structure. The Committee will provide advice regarding developing criteria for identifying a more focused set of measurable, nationally representative objectives. The Committee's advice must assist the Secretary in reducing the number of objectives while ensuring that the selection criteria identifies the most critical public health issues that are high-impact priorities supported by current national data sets.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2016
Document Number: 2016-27315
Type: Notice
Date: 2016-11-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2016, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Agency Information Collection: Comprehensive Child Welfare Information System
Document Number: 2016-27280
Type: Notice
Date: 2016-11-14
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-27261
Type: Notice
Date: 2016-11-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on Measuring Worker Well-being for Total Worker Health[supreg]. This project will provide a tool to measure worker well-being across a range of important domains. Measuring worker well-being is an important initial step towards improving workplace policies, programs, and practices to promote safety and health and prevent disease for employees.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Deviations in Manufacturing
Document Number: 2016-27259
Type: Notice
Date: 2016-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) 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 (the PRA).
Voluntary Qualified Importer Program; Guidance for Industry; Availability
Document Number: 2016-27252
Type: Notice
Date: 2016-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``FDA's Voluntary Qualified Importer Program.'' The guidance describes the Voluntary Qualified Importer Program (VQIP), which provides for expedited review and importation of food offered for importation by importers who voluntarily agree to participate in the program. The guidance describes the eligibility criteria for, and benefits of, participation in VQIP. The guidance also provides information on submitting an application for VQIP participation, obtaining a facility certification for the foreign supplier of a food imported under VQIP, the VQIP user fee, conditions that might result in the revocation of VQIP eligibility, and criteria for reinstatement of eligibility.
Edward Manookian (Also Known as Ed Manning): Debarment Order
Document Number: 2016-27244
Type: Notice
Date: 2016-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
The U.S. Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Edward Manookian from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Manookian was convicted of felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Mr. Manookian was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Manookian failed to request a hearing. Mr. Manookian's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.
National Center for Advancing Translational Sciences; Notice of Meeting
Document Number: 2016-27223
Type: Notice
Date: 2016-11-14
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2016-27222
Type: Notice
Date: 2016-11-14
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; National Hospital Organ Donation Campaign Activity
Document Number: 2016-27219
Type: Notice
Date: 2016-11-14
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement Organization Reporting and Communication; Transplant Outcome Measures and Documentation Requirements; Electronic Health Record (EHR) Incentive Programs; Payment to Nonexcepted Off-Campus Provider-Based Department of a Hospital; Hospital Value-Based Purchasing (VBP) Program; Establishment of Payment Rates Under the Medicare Physician Fee Schedule for Nonexcepted Items and Services Furnished by an Off-Campus Provider-Based Department of a Hospital
Document Number: 2016-26515
Type: Rule
Date: 2016-11-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2017 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. Further, in this final rule with comment period, we are making changes to tolerance thresholds for clinical outcomes for solid organ transplant programs; to Organ Procurement Organizations (OPOs) definitions, outcome measures, and organ transport documentation; and to the Medicare and Medicaid Electronic Health Record Incentive Programs. We also are removing the HCAHPS Pain Management dimension from the Hospital Value-Based Purchasing (VBP) Program. In addition, we are implementing section 603 of the Bipartisan Budget Act of 2015 relating to payment for certain items and services furnished by certain off-campus provider-based departments of a provider. In this document, we also are issuing an interim final rule with comment period to establish the Medicare Physician Fee Schedule payment rates for the nonexcepted items and services billed by a nonexcepted off-campus provider-based department of a hospital in accordance with the provisions of section 603.
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Products
Document Number: 2016-27199
Type: Notice
Date: 2016-11-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on requirements for reporting and recordkeeping, general and specific requirements, and the availability of sample electronic products for manufacturers and distributors of electronic products.
Health IT Policy Committee Advisory Meeting; Notice of Meeting
Document Number: 2016-27174
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services
Health IT Standards Committee Advisory Meeting; Notice of Meeting
Document Number: 2016-27172
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2016-27143
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2016-27142
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2016-27140
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meetings
Document Number: 2016-27139
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meetings
Document Number: 2016-27138
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-27137
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2016-27136
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-27135
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-27134
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services, National Institutes of Health
Amendment to Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion; Draft Guidance for Industry; Availability
Document Number: 2016-27107
Type: Notice
Date: 2016-11-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Amendment to Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion; Draft Guidance for Industry.'' The draft guidance document, when finalized, is intended to amend the document entitled ``Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion'' dated December 2010 (2010 Chagas Guidance) by expanding the scope of the guidance to include the collection of blood and blood components for use in manufacturing a product, including donations intended as a component of, or used to manufacture, a medical device; removing the recommendation to ask donors about a history of Chagas disease; and providing a recommendation for a reentry algorithm for donors deferred on the basis of screening test results for antibodies to Trypanosoma cruzi (T. cruzi) or on the basis of answering ``yes'' to the Chagas screening question. Further, the guidance is intended to notify blood establishments that collect blood and blood components that FDA has licensed a supplemental test for antibodies to T. cruzi and further testing of donations found repeatedly reactive to a screening test for T. cruzi is therefore required. The draft guidance does not apply to the collection of Source Plasma.
Product Labeling for Certain Ultrasonic Surgical Aspirator Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-27106
Type: Notice
Date: 2016-11-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Product Labeling for Certain Ultrasonic Surgical Aspirator Devices.'' FDA is providing a specific labeling recommendation in this guidance to promote the safe and effective use of ultrasonic surgical aspirator devices. The labeling recommendation is being made in light of the risk of tissue dissemination and relates to use of these devices in the removal of uterine fibroid. This draft guidance is not final nor is it in effect at this time.
National Committee on Vital and Health Statistics: Meeting
Document Number: 2016-27083
Type: Notice
Date: 2016-11-09
Agency: Department of Health and Human Services
Performance Review Board Members; Appointments
Document Number: 2016-27082
Type: Notice
Date: 2016-11-09
Agency: Department of Health and Human Services
Medicaid Program; Request for Information (RFI): Federal Government Interventions To Ensure the Provision of Timely and Quality Home and Community Based Services
Document Number: 2016-27040
Type: Proposed Rule
Date: 2016-11-09
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This request for information seeks information and data on additional reforms and policy options that we can consider to accelerate the provision of home and community-based services (HCBS) to Medicaid beneficiaries taking into account issues affecting beneficiary choice and control, program integrity, ratesetting, quality infrastructure, and the homecare workforce.
Submission for OMB Review; Comment Request
Document Number: 2016-27034
Type: Notice
Date: 2016-11-09
Agency: Department of Health and Human Services, Administration for Children and Families
Center for Substance Abuse Prevention; Notice of Meeting
Document Number: 2016-27032
Type: Notice
Date: 2016-11-09
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Medicare Program; Town Hall Meeting on the FY 2018 Applications for New Medical Services and Technologies Add-On Payments
Document Number: 2016-27007
Type: Notice
Date: 2016-11-09
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a Town Hall meeting in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to discuss fiscal year (FY) 2018 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2018 new medical services and technologies applications meet the substantial clinical improvement criterion.
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2016-26971
Type: Notice
Date: 2016-11-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2016-26970
Type: Notice
Date: 2016-11-09
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2016-26969
Type: Notice
Date: 2016-11-09
Agency: Department of Health and Human Services, National Institutes of Health
Medicaid Program; Announcement of Medicaid Drug Rebate Program National Rebate Agreement
Document Number: 2016-26834
Type: Notice
Date: 2016-11-09
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice with comment period announces changes that would be made to the Medicaid National Drug Rebate Agreement (NDRA) for use by the Secretary of the Department of Health and Human Services (HHS) and manufacturers under the Medicaid Drug Rebate Program (MDRP). We are updating the NDRA to incorporate legislative and regulatory changes that have occurred since the agreement was published in the February 21, 1991 Federal Register (56 FR 7049). We are also updating the NDRA to make editorial and structural revisions, such as references to the updated Office of Management and Budget (OMB)- approved data collection forms and electronic data reporting.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-26968
Type: Notice
Date: 2016-11-08
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Submission for OMB Review; Comment Request
Document Number: 2016-26939
Type: Notice
Date: 2016-11-08
Agency: Department of Health and Human Services, Administration for Children and Families
Ninth Annual Sentinel Initiative; Public Workshop
Document Number: 2016-26934
Type: Notice
Date: 2016-11-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Ninth Annual Sentinel Initiative Public Workshop.'' Convened by the Duke-Margolis Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this 1- day workshop will bring the stakeholder community together to discuss a variety of topics on active medical product surveillance. Topics will include an update on the state of FDA's Sentinel Initiative, including an overview of the current state of Sentinel System safety surveillance activities, and uses of the Sentinel System accomplished in 2016. In addition, panelists will discuss the future of the Sentinel System and opportunities to expand its medical product surveillance capabilities. This workshop will also engage stakeholders to discuss current and emerging Sentinel Initiative projects.