Department of Health and Human Services June 2017 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-13835
Type: Notice
Date: 2017-06-30
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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-August 30, 2017
Document Number: 2017-13785
Type: Notice
Date: 2017-06-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, August 30, 2017. This meeting will specifically focus on obtaining the MEDCAC's recommendations regarding the appraisal of the state of evidence for health outcomes in the Medicare population for surgical and endoscopic procedures for weight loss. This meeting is open to the public in accordance with the Federal Advisory Committee Act.
Medicaid Program: Zika Health Care Services Program-Round 2
Document Number: 2017-13784
Type: Notice
Date: 2017-06-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the April 7, 2017 posting of a funding opportunity for Round Two of the Zika Health Care Services Program which provides up to $6.45 million to support prevention activities and treatment services for health conditions related to the Zika virus for entities that meet the eligibility requirements of the Zika Health Care Services Program, but that did not receive an award under the Round One Funding Opportunity. The Round Two Funding Opportunity provides two application due dates, May 8, 2017 and July 10, 2017. Entities eligible to apply for this funding opportunity are states, territories, tribes or tribal organizations, with active or local transmission of the Zika virus, as confirmed by the Centers for Disease Control and Prevention (CDC).
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-13735
Type: Notice
Date: 2017-06-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Center for Mental Health Services; Notice of Meeting
Document Number: 2017-13734
Type: Notice
Date: 2017-06-30
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Information Collection Activity; Comment Request
Document Number: 2017-13726
Type: Notice
Date: 2017-06-30
Agency: Department of Health and Human Services, Administration for Children and Families
Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability
Document Number: 2017-13720
Type: Notice
Date: 2017-06-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) for in vitro diagnostic devices for detection of the Zika virus in response to the Zika virus outbreak in the Americas. FDA issued these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Nanobiosym Diagnostics, Inc. and DiaSorin Inc. The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under the FD&C Act. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.
National Institute of Neurological Disorders and Stroke; Notice of Meeting
Document Number: 2017-13698
Type: Notice
Date: 2017-06-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2017-13697
Type: Notice
Date: 2017-06-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2017-13696
Type: Notice
Date: 2017-06-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-13695
Type: Notice
Date: 2017-06-30
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2017-13694
Type: Notice
Date: 2017-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-13693
Type: Notice
Date: 2017-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-13692
Type: Notice
Date: 2017-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus
Document Number: 2017-13666
Type: Notice
Date: 2017-06-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Roche Molecular Systems, Inc. for the LightMix[supreg] Zika rRT-PCR Test. FDA revoked this Authorization on March 13, 2017, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Roche Molecular Systems, Inc. by letter dated March 10, 2017. The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document.
Authorization of Emergency Use of an Injectable Treatment for Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) Poisoning; Availability
Document Number: 2017-13664
Type: Notice
Date: 2017-06-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an injectable treatment for nerve agent or certain insecticide (organophosphorus and/or carbamate) poisoning. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the U.S. Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized injectable treatment. The Authorization follows the April 11, 2017, determination by the Department of Health and Human Services (HHS) Secretary that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves nerve agents or certain insecticides (organophosphorus and/or carbamate). On the basis of such determination, the HHS Secretary declared on April 11, 2017, that circumstances exist justifying the authorization of emergency use of injectable treatments for nerve agent or certain insecticide (organophosphorus and/or carbamate) poisoning, subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
Medicare Program; CY 2018 Updates to the Quality Payment Program
Document Number: 2017-13010
Type: Proposed Rule
Date: 2017-06-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established the Quality Payment Program for eligible clinicians. Under the Quality Payment Program, eligible clinicians can participate via one of two tracks: Advanced Alternative Payment Models (APMs); or the Merit-based Incentive Payment System (MIPS). We began implementing the Quality Payment Program through rulemaking for calendar year (CY) 2017. This rule provides proposed updates for the second and future years of the Quality Payment Program.
Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices; Public Workshop; Request for Comments
Document Number: 2017-13611
Type: Notice
Date: 2017-06-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices.'' The purpose of this workshop is to discuss potential scientific and regulatory challenges associated with developing traditional antimicrobial susceptibility testing (AST) devices and devices that detect antimicrobial resistance markers by molecular or novel diagnostic technologies, and to provide an overview of relevant provisions of the 21st Century Cures Act that may impact the development of such devices. Public input and feedback gained through this workshop will aid in the development of science-based approaches to regulatory decisionmaking regarding traditional and novel AST devices. Further, this workshop will explore opportunities for the efficient development and evaluation of AST devices, which may lead to better patient care and reduce antimicrobial resistance through improved antibiotic stewardship.
Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II
Document Number: 2017-13609
Type: Notice
Date: 2017-06-29
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 statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for original biologics license applications (BLAs) (351(k)s) submitted under the Public Health Service Act (hereafter referred to as 351(k) applications) (hereafter referred to as the Program). The Program is part of the FDA performance commitments under the proposed reauthorization of the Biosimilar User Fee Act (BsUFA), which, if enacted into law, will allow FDA to collect user fees for the review of 351(k) applications for fiscal years (FYs) 2018-2022. As part of the FDA performance commitments described in this document, the Program will be evaluated by an independent contractor in an interim and final assessment.
Current Good Manufacturing Practice for Medical Gases; Draft Guidance for Industry; Availability
Document Number: 2017-13608
Type: Notice
Date: 2017-06-29
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 revised draft guidance for industry entitled ``Current Good Manufacturing Practice for Medical Gases.'' This guidance is intended to assist manufacturers of medical gases in complying with applicable current good manufacturing practice (CGMP) regulations. Compliance with applicable CGMP requirements helps to ensure the safety, identity, strength, quality, and purity of medical gases. Medical gases that are not manufactured, produced, processed, packed, or held according to applicable CGMP requirements can cause serious injury or death. This guidance is expected to reduce the regulatory compliance burden for the medical gas industry by providing clear, up-to-date, detailed recommendations regarding CGMP issues that have been the subject of industry questions.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2017-13572
Type: Notice
Date: 2017-06-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-13571
Type: Notice
Date: 2017-06-29
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2017-13570
Type: Notice
Date: 2017-06-29
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director; Notice of Meeting
Document Number: 2017-13573
Type: Notice
Date: 2017-06-28
Agency: Department of Health and Human Services, National Institutes of Health
Availability of Program Application Instructions for Tribal MIPPA Program Funds
Document Number: 2017-13530
Type: Notice
Date: 2017-06-28
Agency: Department of Health and Human Services
Notice of Intent To Award a Single Supplement to the National Association of Area Agencies on Aging; The Eldercare Locator
Document Number: 2017-13528
Type: Notice
Date: 2017-06-28
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing supplemental funding for the Eldercare Locator program. The Eldercare Locator program helps older adults and their families and caregivers find their way through the maze of services for older adults by linking to a trustworthy network of national, State, Tribal and community organizations and services through a nationally recognized toll-free number. The Eldercare Locator also provides older adults and caregivers who require more in depth support the opportunity to speak with highly trained eldercare consultants who can better triage the situation. The purpose of this announcement is to award supplemental funds to the National Association of Area Agencies on Aging to support additional staff and enhanced educational tools to better serve callers. Program Name: Eldercare Locator. Award Amount: $134,452. Budget Period: 6/1/2017 to 5/31/2018. Award Type: Cooperative Agreement. Statutory Authority: The statutory authority for grants under this notice is contained in Title IV of the Older Americans Act (OAA) (42 U.S.C. 3032), as amended by the Older Americans Act Amendments of 2006. Statutory authority specifically for the Eldercare Locator is contained in Title II of the Older Americans Act (202(a)(21)). Catalog of Federal Domestic Assistance (CFDA) Number: 93.048 Discretionary Projects.
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings
Document Number: 2017-13468
Type: Notice
Date: 2017-06-28
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2017-13467
Type: Notice
Date: 2017-06-28
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2017-13466
Type: Notice
Date: 2017-06-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-13465
Type: Notice
Date: 2017-06-28
Agency: Department of Health and Human Services, National Institutes of Health
Solicitation for Written Comments on the Development of Healthy People 2030
Document Number: 2017-13463
Type: Notice
Date: 2017-06-28
Agency: Department of Health and Human Services
The Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (HHS), is soliciting written comments on the Healthy People 2030 proposed framework, including the vision, mission, overarching goals, plan of action, and foundational principles. Every 10 years, through the Healthy People initiative, HHS leverages scientific insights and lessons from the past decade along with new knowledge of current data, trends, and innovations to develop the next iteration of national health promotion and disease prevention objectives. Healthy People provides science- based, 10-year national objectives for promoting health and preventing disease. Since 1979, Healthy People has set and monitored national health objectives to meet a broad range of health needs, encouraged collaborations across sectors, guided individuals toward making informed health decisions, and measured the impact of our prevention and health promotion activities. Healthy People 2030 will reflect assessments of major risks to health and wellness, changing public health priorities, new knowledge in prevention, and emerging issues related to our nation's health preparedness.
Reducing Regulatory Burdens Imposed by the Patient Protection and Affordable Care Act & Improving Healthcare Choices To Empower
Document Number: 2017-13417
Type: Proposed Rule
Date: 2017-06-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Office of the Secretary
This document corrects an error that appeared in the request for information notice published in the Federal Register on June 12, 2017 entitled ``Reducing Regulatory Burdens Imposed by the Patient Protection and Affordable Care Act & Improving Healthcare Choices to Empower.''
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-13414
Type: Notice
Date: 2017-06-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Advisory Council for Healthcare Research and Quality: Request for Nominations for Public Members
Document Number: 2017-13396
Type: Notice
Date: 2017-06-27
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Council advises the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to activities of the Agency to carry out its mission. AHRQ's mission is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. epartment of Health and Human Services and with other partners to make sure that the evidence is understood and used. Seven current members' terms will expire in November 2017
Supplemental Evidence and Data Request on Drug Therapy for Early Rheumatoid Arthritis in Adults-An Update
Document Number: 2017-13395
Type: Notice
Date: 2017-06-27
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Drug Therapy for Early Rheumatoid Arthritis in AdultsAn Update, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Supplemental Evidence and Data Request on Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder (PTSD): A Systematic Review Update
Document Number: 2017-13394
Type: Notice
Date: 2017-06-27
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Psychological and Pharmacological Treatments for Adults with Posttraumatic Stress Disorder (PTSD): A Systematic Review Update, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Meeting of the National Advisory Council for Healthcare Research and Quality
Document Number: 2017-13393
Type: Notice
Date: 2017-06-27
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2017-13363
Type: Notice
Date: 2017-06-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2017-13362
Type: Notice
Date: 2017-06-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Disease; Notice of Closed Meetings
Document Number: 2017-13361
Type: Notice
Date: 2017-06-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2017-13360
Type: Notice
Date: 2017-06-27
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute Amended; Notice of Meeting
Document Number: 2017-13359
Type: Notice
Date: 2017-06-27
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2017-13358
Type: Notice
Date: 2017-06-27
Agency: Department of Health and Human Services
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention-State, Tribal, Local and Territorial (STLT) Subcommittee
Document Number: 2017-13339
Type: Notice
Date: 2017-06-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-13321
Type: Notice
Date: 2017-06-26
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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-13320
Type: Notice
Date: 2017-06-26
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. As part of a Broad Agency Announcement (BAA) issued for the competitive selection of research proposals, this notice invites comment on the proposed information collection project titled ``Applied Research to Address Emerging Public Health Priorities.''
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2017-13314
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Lists of Designated Primary Medical Care, Mental Health, and Dental Health Professional Shortage Areas
Document Number: 2017-13313
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
This notice informs the public of the availability of the complete lists of all geographic areas, population groups, and facilities designated as primary medical care, mental health, and dental health professional shortage areas (HPSAs) as of May 1, 2017. The lists are available on HRSA's HPSAFind Web site.
Low-Income Levels Used for Various Health Professions and Nursing Programs Authorized in Titles III, VII, and VIII of the Public Health Service Act
Document Number: 2017-13312
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is updating income levels used to identify a ``low-income family'' for the purpose of determining eligibility for programs that provide health professions and nursing training to individuals from disadvantaged backgrounds. These various programs are authorized in Titles III, VII, and VIII of the Public Health Service Act. HHS periodically publishes in the Federal Register low-income levels to be used by institutions receiving federal grants and cooperative agreements to determine eligibility for programs providing training for (1) disadvantaged individuals, (2) individuals from disadvantaged backgrounds, or (3) individuals from low-income families.