Premarket Notification Submissions for Electrosurgical Devices for General Surgery; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery.'' FDA has developed this guidance document to assist industry in preparing premarket notification (510(k)) submissions for electrosurgical devices intended for use in general surgery.
Premarket Notification Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery.'' FDA has developed this guidance document to assist industry in preparing premarket notification (510(k)) submissions for bipolar electrosurgical vessel sealers intended for use in general surgery.
NIOSH Center for Motor Vehicle Safety: Midcourse Review of Strategic Plan
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces a public web meeting and an opportunity to comment on future directions for the NIOSH Center for Motor Vehicle Safety. To view the notice and related materials, visit http://www.regulations.gov and enter CDC-2016-0067 in the search field and click ``Search.''
Notice of Single-Award Deviation From Competition Requirements for the National Center for Medical Home Implementation Cooperative Agreement
HRSA announces the award of a supplement in the amount of $300,000 per year for two years for the National Center for Medical Home Implementation (NCMHI) Cooperative Agreement cooperative agreement. The purpose of the NCMHI cooperative agreement, as stated in the funding opportunity announcement, is to: (1) Support a national resource and assistance effort to implement and spread the medical home model to all children and youth, particularly children with special health care needs (CSHCN), children who are vulnerable and/or medically underserved, and pediatric populations served by state public health programs, MCHB and HRSA; and (2) support activities of the Healthy Tomorrows Partnership for Children Program (HTPCP) grantees to improve children's health through innovative community-based efforts, and community and statewide partnerships among professionals in health, education, social services, government, and business. The supplement will permit the American Academy of Pediatrics (AAP), the cooperative agreement awardee, during the budget periods of 7/1/2016-6/30/2017 and 7/1/2017-6/30/2018, to provide technical assistance to the Rural IMPACT communities as they employ two-generation strategies to more effectively support children living in poverty in rural communities, including the implementation and spread of the family-centered medical home model of health care.
Allergenic Products Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Allergenic Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public.
Facilitating Anti-Infective Drug Development for Neonates and Young Infants; Notice of Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop regarding anti-infective drug development for neonates and young infants. FDA is interested in discussing the scientific challenges pertaining to development of anti-infective products for neonates and young infants. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. Government Agencies, public health organizations, academic experts, and industry on various aspects of drug development for new and currently marketed anti-infective drugs for neonates and young infants. The input from this public workshop will also help in developing topics for future discussion.
Request for Nominations on the Tobacco Products Scientific Advisory Committee
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting member to represent the interests of tobacco growers to serve on the Tobacco Products Scientific Advisory Committee for the Center for Tobacco Products (CTP), notify FDA in writing. FDA is also requesting nominations for a nonvoting member to represent the interests of tobacco growers to serve on the Tobacco Products Scientific Advisory Committee, and an alternate to this representative. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Notice of Availability: Test Tools and Test Procedures Approved by the National Coordinator for the ONC Health IT Certification Program
This notice announces the availability of test procedures and the Cypress version 3.0 test tool approved by the National Coordinator for Health Information Technology (the National Coordinator) for the testing of Health IT Modules to four 2015 Edition health information technology (health IT) certification criteria under the ONC Health IT Certification Program.
Medicaid Program; Disproportionate Share Hospital Payments-Treatment of Third Party Payers in Calculating Uncompensated Care Costs
This proposed rule addresses the hospital-specific limitation on Medicaid disproportionate share hospital (DSH) payments under section 1923(g)(1)(A) of the Social Security Act (Act), and the application of such limitation in the annual DSH audits required under section 1923(j) of the Act, by clarifying that the hospital-specific DSH limit is based only on uncompensated care costs. Specifically, this rule would make clearer in the text of the regulation an existing interpretation that uncompensated care costs include only those costs for Medicaid eligible individuals that remain after accounting for payments received by hospitals by or on behalf of Medicaid eligible individuals, including Medicare and other third party payments that compensate the hospitals for care furnished to such individuals. As a result, the hospital-specific limit calculation would reflect only the costs for Medicaid eligible individuals for which the hospital has not received payment from any source (other than state or local governmental payments for indigent patients).
Control of Communicable Diseases
Through this Notice of Proposed Rulemaking (NPRM), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is amending its domestic (interstate) and foreign quarantine regulations to best protect the public health of the United States. These amendments are being proposed to aid public health responses to outbreaks of communicable diseases such as the largest recorded outbreak of Ebola virus disease (Ebola) in history, the recent outbreak of Middle East Respiratory Syndrome (MERS) in South Korea, and repeated outbreaks and responses to measles in the United States, as well as the ongoing threat of other new or re-emerging communicable diseases. The provisions contained herein provide additional clarity to various safeguards to prevent the importation and spread of communicable diseases affecting human health into the United States and interstate.