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

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Determination of Regulatory Review Period for Purposes of Patent Extension; BRINEURA
Document Number: 2018-22559
Type: Notice
Date: 2018-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BRINEURA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Medicare and Medicaid Program; Application from the Accreditation Association for Hospitals/Health Systems-Healthcare Facilities Accreditation Program (AAHHS-HFAP) for Approval of its Hospital Accreditation Program
Document Number: 2018-22546
Type: Notice
Date: 2018-10-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from the Accreditation Association for Hospitals/Health Systems-Healthcare Facilities Accreditation Program (AAHHS-HFAP) for recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.
Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2019
Document Number: 2018-22530
Type: Notice
Date: 2018-10-17
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, 2019. In addition, this notice announces the monthly premium for aged and disabled beneficiaries, the deductible for 2019, 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 2019 are $264.90 for aged enrollees and $315.40 for disabled enrollees. The standard monthly Part B premium rate for all enrollees for 2019 is $135.50, 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 the $3.00 repayment amount required under current law. (The 2018 standard premium rate was $134.00, which also included the $3.00 repayment amount.) The Part B deductible for 2019 is $185.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, he or she will have to pay a total monthly premium of about 35, 50, 65, 80, or 85 percent of the total cost of Part B coverage plus a repayment amount of $4.20, $6.00, $7.80, $9.60, or $10.20, respectively.
Medicare Program; CY 2019 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement
Document Number: 2018-22529
Type: Notice
Date: 2018-10-17
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) 2019. 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, 2019 for these individuals will be $437. The premium for certain other individuals as described in this notice will be $240.
Medicare Program; CY 2019 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts
Document Number: 2018-22526
Type: Notice
Date: 2018-10-17
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) 2019 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2019, the inpatient hospital deductible will be $1,364. The daily coinsurance amounts for CY 2019 will be: $341 for the 61st through 90th day of hospitalization in a benefit period; $682 for lifetime reserve days; and $170.50 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.
Implementation of Section 2695 (42 U.S.C. 300ff-131) Public Law 111-87: Infectious Diseases and Circumstances Relevant to Notification Requirements: Definition of Emergency Response Employee
Document Number: 2018-22522
Type: Notice
Date: 2018-10-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is adding a definition of the term ``emergency response employees'' to the definitions section of the document entitled ``Implementation of Section 2695 (42 U.S.C. 300ff-131) Public Law 111-87: Infectious Diseases and Circumstances Relevant to Notification Requirements,'' which contains a list of potentially life-threatening infectious diseases to which emergency response employees may be exposed and companion guidelines published by the National Institute for Occupational Safety and Health (NIOSH), pursuant to the Ryan White HIV/ AIDS Treatment Extension Act of 2009.
Performance Review Board Members
Document Number: 2018-22491
Type: Notice
Date: 2018-10-16
Agency: Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: 2018-22461
Type: Notice
Date: 2018-10-16
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Submission for Office of Management and Budget (OMB) Review; Comment Request
Document Number: 2018-22446
Type: Notice
Date: 2018-10-16
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Information Collection Activity
Document Number: 2018-22441
Type: Notice
Date: 2018-10-16
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) seeks to continue data collection for the Annual Survey of Refugees with minor updates to improve survey administration procedures. The Annual Survey of Refugees is a yearly sample survey of refugees entering the U.S. in the previous five fiscal years. No changes to the survey instrument or estimated response burden are proposed. Data from the Annual Survey of Refugees are used to meet the Office of Refugee Resettlement's Congressional reporting requirements, as set forth in the Refugee Act of 1980 (Section 413(a) of the Immigration and Nationality Act). The ACF Office of Refugee Resettlement makes aggregated survey findings available to the general public and uses findings for the purposes of program planning, policy-making, and budgeting. Respondents: The Annual Survey of Refugees secures a nationally- representative sample of refugee households arriving in the United States in the previous five fiscal years.
Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease; Guidance for Industry; Availability
Document Number: 2018-22437
Type: Notice
Date: 2018-10-16
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 final guidance for industry entitled ``Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.'' This final guidance incorporates public comments to the draft guidance published in the Federal Register of December 18, 2017. The pharmacological effect of a targeted therapy is often related to a particular molecular alteration, and many diseases are caused by a range of different molecular alterations (some of which may be rare). Therefore, a targeted therapy may have differential effects among patients with the same disease who have different molecular alterations. The purpose of this guidance is to describe general approaches to evaluating the benefits and risks of targeted therapeutics within a clinically defined disease where some molecular alterations may occur at low frequencies.
Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment; Draft Guidance for Industry; Availability
Document Number: 2018-22436
Type: Notice
Date: 2018-10-16
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 guidance for industry entitled ``Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.'' This draft guidance is intended to assist sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application (IND) or to support marketing approval of drugs and biological products for the treatment of specific hematologic malignancies.
Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings; Draft Guidance for Industry; Availability
Document Number: 2018-22435
Type: Notice
Date: 2018-10-16
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 guidance for industry entitled ``Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings.'' The purpose of this draft guidance is to assist sponsors of drug and biological products for the treatment of rare diseases in planning and conducting more efficient and productive pre-investigational new drug application (pre-IND) meetings. Drug development for rare diseases has many challenges related to the nature of these diseases. This draft guidance is intended to advance and facilitate the development of drugs and biological products for the treatment of rare diseases.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-22409
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Privacy Act of 1974; Matching Program
Document Number: 2018-22405
Type: Notice
Date: 2018-10-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of a re-established matching program between CMS and each State Based Administering Entity (AE), titled ``Determining Eligibility for Enrollment in Applicable State Health Subsidy Programs Under the Patient Protection and Affordable Care Act.''
Draft Guideline: Infection Control in Healthcare Personnel: Infrastructure and Routine Practices for Occupational Infection Prevention and Control Services
Document Number: 2018-22377
Type: Notice
Date: 2018-10-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (DHHS), announces the opening of a docket to obtain comment on the Draft Guideline: Infection Control in Healthcare Personnel: Infrastructure and Routine Practices for Occupational Infection Prevention and Control Services (Draft Guideline). The Draft Guideline is an update of two sections of the Guideline for Infection Control in Healthcare Personnel, 1998: C. Infection Control Objectives for a Personnel Health Service and D. Elements of a Personnel Health Service for Infection Control. The updated recommendations in the Draft Guideline are intended to facilitate the provision of occupational infection prevention and control services to healthcare personnel and to prevent transmission of infections between healthcare personnel and others.
Pathogen Reduction Technologies for Blood Safety; Public Workshop; Correction
Document Number: 2018-22364
Type: Notice
Date: 2018-10-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a document that appeared in the Federal Register of September 17, 2018. The document announced a public workshop entitled ``Pathogen Reduction Technologies for Blood Safety; Public Workshop.'' The document was published with an error in the website address to register for the workshop. This document corrects that error.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-22360
Type: Notice
Date: 2018-10-15
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. to achieve expeditious commercialization of results of federally-funded research and development.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-22359
Type: Notice
Date: 2018-10-15
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 to achieve expeditious commercialization of results of federally-funded research and development.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-22358
Type: Notice
Date: 2018-10-15
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 effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled One Health Harmful Algal Bloom System (OHHABS). The OHHABS is a voluntary reporting system available to state and territorial public health departments and their designated environmental health or animal health partners. It collects data on individual human and animal cases of illnesses from harmful algal bloom (HAB)-associated exposures, as well as environmental data about HABs.
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: 2018-22344
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: 2018-22343
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: 2018-22342
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Submission for OMB Review; 30-Day Comment Request; Intramural Continuing Umbrella of Research Experiences (iCURE) Application-National Cancer Institute
Document Number: 2018-22319
Type: Notice
Date: 2018-10-15
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-22318
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-22317
Type: Notice
Date: 2018-10-15
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 to achieve expeditious commercialization of results of federally-funded research and development.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-22316
Type: Notice
Date: 2018-10-15
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. to achieve expeditious commercialization of results of federally-funded research and development.
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2018-22315
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2018-22314
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-22313
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-22312
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-22311
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2018-22310
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2018-22309
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice to Close Meeting
Document Number: 2018-22308
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, National Institutes of Health
Solicitation for Nominations To Serve on the Advisory Council To Support Grandparents Raising Grandchildren
Document Number: 2018-22269
Type: Notice
Date: 2018-10-12
Agency: Department of Health and Human Services
The Secretary of Health & Human Services (Secretary) seeks nominations for grandparents who are raising grandchildren and older relatives who are caring for children to serve on the Advisory Council to Support Grandparents Raising Grandchildren.
Solicitation for Nominations To Serve on the Family Caregiving Advisory Council
Document Number: 2018-22268
Type: Notice
Date: 2018-10-12
Agency: Department of Health and Human Services
The Secretary of Health & Human Services (Secretary) seeks nominations for individuals to serve on the Family Caregiving Advisory Council.
Agency Information Collection Activity; Proposed Collection: Public Comment Request; One Protection and Advocacy Annual Program Performance Report
Document Number: 2018-22266
Type: Notice
Date: 2018-10-12
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed new data collection (ICR New) listed above. 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, 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 seeks to collect comments on the proposed new data collection (ICR New), which will replace four existing Protection and Advocacy Program Performance Reports and other revisions. The four annual reports include the following: (1) Developmental Disabilities Protection and Advocacy Systems Program Performance Report (0985-0027), (2) Protection and Advocacy for Assistive Technology (PAAT) Program Performance Report (0985-0046); (3) Protection and Advocacy Voting Access Annual Report (Help America Vote Act) (HAVA) (0985-0028); and (4) Protection and Advocacy for Traumatic Brain Injury (PATBI) Program Performance Report (0985-0058). State Protection and Advocacy (P&A) Systems in each State and Territory provide individual legal advocacy, systemic advocacy, monitoring and investigations to protect and advance the rights of people with developmental disabilities, using funding administered by the Administration on Intellectual and Developmental Disabilities (AIDD), Administration on Disabilities, Administration for Community Living, HHS. To meet statutory reporting requirements, P&As have used four separate forms for submitting annual reports. It is proposed that the four forms be combined by creating the One Protection and Advocacy Annual Program Performance Report form. Once the four program performance reports are combined, the current OMB approval numbers for each report will be retired, and a new approval number will be created for the One Protection and Advocacy Program Performance Report.
Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee, Renewal
Document Number: 2018-22183
Type: Notice
Date: 2018-10-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Dermatologic and Ophthalmic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Dermatologic and Ophthalmic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until October 7, 2020.
Charter Renewal of the Secretary's Advisory Committee on Human Research Protections
Document Number: 2018-22167
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) is hereby giving notice that the charter for the Secretary's Advisory Committee on Human Research Protections (SACHRP) has been renewed.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2018-22101
Type: Notice
Date: 2018-10-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Advisory Committee; Antimicrobial Drugs Advisory Committee, Renewal
Document Number: 2018-22098
Type: Notice
Date: 2018-10-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Antimicrobial Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Antimicrobial Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until October 7, 2020.
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2018-22091
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-22090
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-22089
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2018-22088
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2018-22087
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2018-22086
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-22085
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings
Document Number: 2018-22080
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services, National Institutes of Health