Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use
The Food and Drug Administration (FDA, we, or the Agency) is issuing this final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water (referred to throughout this document as consumer antiseptic washes) are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded. FDA is issuing this final rule after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC); public comments on the Agency's notices of proposed rulemaking; and all data and information on OTC consumer antiseptic wash products that have come to the Agency's attention. This final rule amends the 1994 tentative final monograph (TFM) for OTC antiseptic drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM). The final rule is part of the ongoing review of OTC drug products conducted by FDA.
Submission for OMB Review; 30-Day Comment Request; NIDDK Office of Minority Health Research Coordination (OMHRC) Research Training and Mentor Programs Applications (National Institute of Diabetes and Digestive and Kidney Diseases)
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 (Vol. 81, No. 93, page 29877) on May 13, 2016 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.
Request for Public Comment on Draft Health Center Program Compliance Manual
HRSA is inviting public comment on the Draft Health Center Program Compliance Manual, hereafter referred to as the Compliance Manual. The purpose of the Compliance Manual is to provide a consolidated web-based resource to assist current and prospective health centers in understanding and demonstrating compliance with requirements of the Health Center Program, a HRSA-administered program authorized under 42 U.S.C. 254b. The Compliance Manual identifies requirements found in the Health Center Program's authorizing legislation and implementing regulations, as well as certain applicable grant regulations. The Compliance Manual also addresses HRSA's approach to determining eligibility for and oversight of the Health Center Program. In addition, the Compliance Manual includes the requirements for obtaining deemed Public Health Service (PHS) employee status under the Federally Supported Health Centers Assistance Acts of 1992 and 1995, for purposes of Federal Tort Claims Act (FTCA) liability protections for the performance of medical, surgical, dental, and related functions within the scope of deemed PHS employment.
Senior Executive Service Performance Review Board
In this notice, the Health Resources and Services Administration (HRSA) located within the Department of Health and Human Services (HHS) publishes a list of persons who may be named to serve on the Performance Review Board that oversees the evaluation of performance appraisals for Senior Executive Service members within HRSA.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 The National Violent Death Reporting System (NVDRS) to continue collecting state- based surveillance data on violent deaths that will provide more detailed and timely information.
Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program
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 application for participation in the Medical Device Fellowship Program.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Determination That AQUAMEPHYTON (Phytonadione) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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.
Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2018
This proposed rule sets forth payment parameters and provisions related to the risk adjustment program; cost-sharing parameters and cost-sharing reductions; and user fees for Federally- facilitated Exchanges and State-based Exchanges on the Federal platform. It also provides additional guidance relating to standardized options; qualified health plans; consumer assistance tools; network adequacy; the Small Business Health Options Program; stand-alone dental plans; fair health insurance premiums; guaranteed renewability; the medical loss ratio program; eligibility and enrollment; appeals; and other related topics.
Head Start Performance Standards
This final rule modernizes the Head Start Program Performance Standards, last revised in 1998. In the Improving Head Start for School Readiness Act of 2007, Congress instructed the Office of Head Start to update its performance standards and to ensure any such revisions to the standards do not eliminate or reduce quality, scope, or types of health, educational, parental involvement, nutritional, social, or other services programs provide. This rule responds to public comment, incorporates extensive findings from research and from consultation with experts, reflects best practices, lessons from program input and innovation, integrates recommendations from the Secretary's Advisory Committee Final Report on Head Start Research and Evaluation, and reflects the Obama Administration's deep commitment to improve the school readiness of young children. These performance standards will improve program quality, reduce burden on programs, and improve regulatory clarity and transparency. They provide a clear road map for current and prospective grantees to support high-quality Head Start services and to strengthen the outcomes of the children and families Head Start serves.
Adjustment of Civil Monetary Penalties for Inflation
The Department of Health and Human Services (HHS) is issuing a new regulation to adjust for inflation the maximum civil monetary penalty amounts for the various civil monetary penalty authorities for all agencies within HHS. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. In addition, this interim final rule includes updates to certain agency-specific regulations to identify their updated information, and note the location of HHS-wide regulations.