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

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.

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.

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.

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.

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.

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.''

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

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.

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.''

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.