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

Results 101 - 150 of 300
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2016-27878
Type: Notice
Date: 2016-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2016-27877
Type: Notice
Date: 2016-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2016-27876
Type: Notice
Date: 2016-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-27875
Type: Notice
Date: 2016-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2016-27874
Type: Notice
Date: 2016-11-21
Agency: Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-27873
Type: Notice
Date: 2016-11-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-27872
Type: Notice
Date: 2016-11-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-27871
Type: Notice
Date: 2016-11-21
Agency: Department of Health and Human Services, National Institutes of Health
Determination That BENEMID (Probenecid) Tablet and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2016-27855
Type: Notice
Date: 2016-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification
Document Number: 2016-27851
Type: Notice
Date: 2016-11-18
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 medical device premarket notification.
Use of The Seafood List To Determine Acceptable Seafood Names; Draft Compliance Policy Guide; Availability
Document Number: 2016-27843
Type: Notice
Date: 2016-11-18
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 draft guidance for FDA staff entitled ``Compliance Policy Guide Sec. 540.750 Use of The Seafood List to Determine Acceptable Seafood Names'' (the draft Compliance Policy Guide (CPG)). The draft CPG, when finalized, will provide guidance for FDA staff regarding use of The Seafood List to determine whether a seafood name is acceptable.
Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-27842
Type: Notice
Date: 2016-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.'' This guidance provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD).
Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Special Protocol Assessment
Document Number: 2016-27840
Type: Notice
Date: 2016-11-18
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 the information collection in the guidance for industry on special protocol assessment.
Submission for OMB Review; 30-Day Comment Request: A National Survey of Nurse Coaches (NIH Clinical Center)
Document Number: 2016-27839
Type: Notice
Date: 2016-11-18
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 22, 2016, pages 56668-9 (81 FR 56668) and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements
Document Number: 2016-27838
Type: Rule
Date: 2016-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is amending its current good manufacturing practice (CGMP) and labeling regulations regarding medical gases. FDA is requiring that portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer. FDA is also requiring that portable cryogenic medical gas containers and high-pressure medical gas cylinders meet certain labeling, naming, and color requirements. These requirements are intended to increase the likelihood that the contents of medical gas containers are accurately identified and reduce the likelihood of the wrong gas being connected to a gas supply system or container. FDA is also revising an existing regulation that conditionally exempts certain medical gases from certain otherwise-applicable labeling requirements in order to add oxygen and nitrogen to the list of gases subject to the exemption, and to remove cyclopropane and ethylene from the list.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-27836
Type: Notice
Date: 2016-11-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Notice of Joint Meeting by the Urology Interagency Coordinating Committee and the Diabetes Mellitus Interagency Coordinating Committee Meeting
Document Number: 2016-27825
Type: Notice
Date: 2016-11-18
Agency: Department of Health and Human Services, National Institutes of Health
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) and the Urology Interagency Coordinating Committee (UICC) will hold a joint meeting on December 16, 2016. The subject of the meeting will be ``The Urologic Complications of Diabetes.'' The meeting is open to the public.
Government-Owned Inventions; Availability for Licensing and/or Co-Development
Document Number: 2016-27770
Type: Notice
Date: 2016-11-18
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. to achieve expeditious commercialization of results 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 and/or co-development.
Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Document Number: 2016-27769
Type: Notice
Date: 2016-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research (CBER). This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.
Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates; Guidance for Industry; Availability
Document Number: 2016-27768
Type: Notice
Date: 2016-11-18
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 document entitled ``Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates; Guidance for Industry.'' The guidance document provides establishments that make donor eligibility (DE) determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) with information on infectious-disease risks related to receipt of FDA licensed human-derived clotting factor concentrates (HDCFCs). The guidance explains that FDA no longer considers FDA licensed HDCFCs as a risk factor for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV). As such, receipt of FDA licensed HDCFCs, or sex with a person who has received FDA licensed HDCFCs, should not be considered a risk factor when determining eligibility of a donor of HCT/Ps. The guidance supplements the recommendations regarding HDCFCs that are contained in the guidance entitled ``Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry'' dated August 2007.
Bacillus Calmette-Guerin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment; Draft Guidance for Industry; Availability
Document Number: 2016-27762
Type: Notice
Date: 2016-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Bacillus Calmette-Guerin (BCG)Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment.'' The purpose of this guidance is to assist sponsors in the development of drugs and biologics to treat patients with a high-risk form of bladder cancer. The alternative is radical cystectomy, a surgical procedure with significant morbidity and mortality. This guidance will help overcome some of the obstacles in conducting the studies needed to establish efficacy of drugs and biologics for these patients with an unmet medical need.
Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments; Guidance for Industry; Availability
Document Number: 2016-27761
Type: Notice
Date: 2016-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of guidance for industry entitled ``Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments.'' This guidance provides updated answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding GDUFA user fees and finalizes the revised version of the guidance.
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: 2016-27733
Type: Rule
Date: 2016-11-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors in the final rule that was placed on public inspection at the Office of the Federal Register on November 2, 2016 and scheduled for publication in the Federal Register on November 15, 2016. That rule is entitled, ``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.''
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-27705
Type: Notice
Date: 2016-11-18
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Pharmacy Survey on Patient Safety Culture Comparative Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-27693
Type: Notice
Date: 2016-11-17
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 ``Data Calls for the Laboratory Response Network'' collected from its members concerning their capacity to respond to public health threat emergencies.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-27692
Type: Notice
Date: 2016-11-17
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 Zika Virus Associated Neurologic Illness Case Control Study. This collection intends to identify potential risk factors for the development of severe neurologic illnesses using a case-control investigation.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-27691
Type: Notice
Date: 2016-11-17
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 information collection project entitled ``ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia.'' This collection intends to identify risk factors for Zika virus (ZIKV) infection in pregnant women and their infants, assess the risk for adverse maternal, fetal, and infant outcomes associated with ZIKV infection and, assess modifiers of the risk for adverse outcomes among pregnant women and their infants following ZIKV infection.
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2016-27677
Type: Notice
Date: 2016-11-17
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Invention; Availability for Licensing
Document Number: 2016-27676
Type: Notice
Date: 2016-11-17
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing in the U.S. to achieve expeditious commercialization of results 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.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2016-27675
Type: Notice
Date: 2016-11-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-27674
Type: Notice
Date: 2016-11-17
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing and/or Co-Development
Document Number: 2016-27613
Type: Notice
Date: 2016-11-17
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. to achieve expeditious commercialization of results 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 and/or co-development.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-27550
Type: Notice
Date: 2016-11-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Proposed Collection; Comment Request; Correction
Document Number: 2016-27549
Type: Notice
Date: 2016-11-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects the information provided for [Document Identifier: CMS-10169] titled ``Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program; Change of Ownership Forms.''
Office of Public Health Preparedness and Response (OPHPR) Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR)
Document Number: 2016-27493
Type: Notice
Date: 2016-11-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services, Department of Health and Human Services (hhs)
Advisory Council for the Elimination of Tuberculosis Meeting (ACET)
Document Number: 2016-27492
Type: Notice
Date: 2016-11-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers; Correction
Document Number: 2016-27478
Type: Rule
Date: 2016-11-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects typographical errors that appeared in the final rule published in the Federal Register on September 16, 2016 entitled ``Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers.''
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2016-27463
Type: Notice
Date: 2016-11-16
Agency: Department of Health and Human Services
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2016-27462
Type: Notice
Date: 2016-11-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-27461
Type: Notice
Date: 2016-11-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-27460
Type: Notice
Date: 2016-11-16
Agency: Department of Health and Human Services, National Institutes of Health
Refuse To Accept Procedures for Premarket Tobacco Product Submissions; Withdrawal
Document Number: 2016-27456
Type: Rule
Date: 2016-11-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) published in the Federal Register of August 8, 2016, a direct final rule regarding procedures for refusing to accept premarket tobacco product submissions. The comment period closed October 24, 2016. FDA is withdrawing the direct final rule because the Agency received significant adverse comment. FDA will consider the comments we received on the direct final rule to be comments on the companion proposed rule published at 81 FR 52371 (August 8, 2016).
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-27455
Type: Notice
Date: 2016-11-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Site Visit Training Program for Office of Pharmaceutical Quality Staff; Information Available to Industry
Document Number: 2016-27454
Type: Notice
Date: 2016-11-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Center for Drug Evaluation and Research (CDER) in the Food and Drug Administration (FDA) is announcing the 2017 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. The purpose of this document is to invite pharmaceutical companies interested in participating in this program to submit a site visit proposal to CDER's OPQ.
Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rate, and Annual Deductible Beginning January 1, 2017
Document Number: 2016-27425
Type: Notice
Date: 2016-11-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2017. In addition, this notice announces the monthly premium for aged and disabled beneficiaries, the deductible for 2017, and the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2017 are $261.90 for aged enrollees and $254.20 for disabled enrollees. The standard monthly Part B premium rate for all enrollees for 2017 is $134.00, which is equal to 50 percent of the monthly actuarial rate for aged enrollees (or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees) plus $3.00. (The 2016 standard premium rate was $121.80, which includes the $3.00 repayment amount.) The Part B deductible for 2017 is $183.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, they will have to pay a total monthly premium of about 35, 50, 65, or 80 percent of the total cost of Part B coverage plus $4.20, $6.00, $7.80, or $9.60.
Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, the Children's Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2017 Through September 30, 2018
Document Number: 2016-27424
Type: Notice
Date: 2016-11-15
Agency: Department of Health and Human Services
The Federal Medical Assistance Percentages (FMAP), Enhanced Federal Medical Assistance Percentages (eFMAP), and disaster-recovery FMAP adjustments for Fiscal Year 2018 have been calculated pursuant to the Social Security Act (the Act). These percentages will be effective from October 1, 2017 through September 30, 2018. This notice announces the calculated FMAP rates, in accordance with sections 1101(a)(8) and 1905(b) of the Act, that the U.S. Department of Health and Human Services (HHS) will use in determining the amount of federal matching for state medical assistance (Medicaid), Temporary Assistance for Needy Families (TANF) Contingency Funds, Child Support Enforcement collections, Child Care Mandatory and Matching Funds of the Child Care and Development Fund, Title IV-E Foster Care Maintenance payments, Adoption Assistance payments and Guardianship Assistance payments, and the eFMAP rates for the Children's Health Insurance Program (CHIP) expenditures. Table 1 gives figures for each of the 50 states, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. This notice reminds states of available disaster-recovery FMAP adjustments for qualifying states, and adjustments available for states meeting requirements for negative growth in total state personal income. At this time, no states qualify for such adjustments. This notice also contains the increased eFMAPs for CHIP as authorized under the Patient Protection and Affordable Care Act (Affordable Care Act) for fiscal years 2016 through 2019 (October 1, 2015 through September 30, 2019). Programs under title XIX of the Act exist in each jurisdiction. Programs under titles I, X, and XIV operate only in Guam and the Virgin Islands. The percentages in this notice apply to state expenditures for most medical assistance and child health assistance, and assistance payments for certain social services. The Act provides separately for federal matching of administrative costs. Sections 1905(b) and 1101(a)(8)(B) of the Social Security Act (the Act) require the Secretary of HHS to publish the FMAP rates each year. The Secretary calculates the percentages, using formulas in sections 1905(b) and 1101(a)(8), and calculations by the Department of Commerce of average income per person in each state and for the Nation as a whole. The percentages must fall within the upper and lower limits specified in section 1905(b) of the Act. The percentages for the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands are specified in statute, and thus are not based on the statutory formula that determines the percentages for the 50 states.
Medicaid Program; Covered Outpatient Drug; Delay in Change in Definitions of States and United States
Document Number: 2016-27423
Type: Rule
Date: 2016-11-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Covered Outpatient Drug final rule with comment period was published in the February 1, 2016 Federal Register. As part of that final rule with comment, we amended the regulatory definitions of ``States'' and ``United States'' to include the U.S. territories (American Samoa, the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, and the Virgin Islands) beginning April 1, 2017. This interim final rule with comment period delays the inclusion of the territories in the definition of ``States'' and ``United States'' until April 1, 2020.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-27421
Type: Notice
Date: 2016-11-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Paul S. Singh: Debarment Order
Document Number: 2016-27418
Type: Notice
Date: 2016-11-15
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 Paul S. Singh 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 Dr. Singh was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Dr. Singh was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Singh failed to request a hearing. Dr. Singh's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.
Louis Daniel Smith: Debarment Order
Document Number: 2016-27417
Type: Notice
Date: 2016-11-15
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 Louis Daniel Smith 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. Smith was convicted of felonies under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product, or otherwise relating to the regulation of a drug product under the FD&C Act. Mr. Smith was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Smith failed to respond. Mr. Smith's failure to respond constitutes a waiver of his right to a hearing concerning this action.