Department of Health and Human Services November 26, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 15 of 15
Prospective Grant of an Exclusive Patent License: Gene Therapy for Ocular Disease
The National Eye Institute, the National Institute on Deafness and Other Communication Disorders, and the National Heart, Lung, and Blood Institute, institutes of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an exclusive patent license to OcQuila Therapeutics Ltd., a C corporation incorporated under the laws of the state of Delaware and a limited company incorporated under the laws of the United Kingdom, to practice the inventions covered by the patent estate listed in the Supplementary Information section of this notice.
Premarket Tobacco Product Applications and Recordkeeping Requirements; Reopening of the Comment Period
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the proposed rulemaking that appeared in the Federal Register of September 25, 2019. The Agency is taking this action in response to a request for an extension to the comment period to allow interested persons additional time to submit comments.
2019 Interagency Autism Coordinating Committee Call for Nominations Announcement
The Office of the Secretary of the Department of Health and Human Services (HHS) is seeking nominations of individuals to serve as non-federal public members on the Interagency Autism Coordinating Committee (IACC).
Interagency Coordinating Committee on the Validation of Alternative Methods Communities of Practice Webinar on Use of Animal-Free Affinity Reagents; Notice of Public Webinar; Registration Information
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) announces a public webinar ``Use of Animal-free Affinity Reagents.'' The webinar is organized on behalf of ICCVAM by the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). Interested persons may participate via WebEx. Time will be allotted for questions from the audience. Information about the webinar and registration are available at https://ntp.niehs.nih.gov/go/commprac-2020.
Head Start Program
The Office of Head Start will further delay the compliance date for programs to meet the new comprehensive background checks requirements and to participate in their state or local Quality Rating and Improvement Systems (QRIS). We are delaying the compliance date for these standards, based on concerns states still will not have systems developed that can accommodate Head Start programs by the current compliance date. Head Start programs are still encouraged to conduct comprehensive background checks where state systems support Head Start requests and are required to meet the background check requirements in section 648A of the Head Start Act that requires them to obtain a State, tribal, or Federal criminal record check for all staff members prior to employment. The Office of Head Start also requests comments on the issues set out in this final rule.
Center for Devices and Radiological Health Ethylene Oxide Sterilization Master File Pilot Program
The Food and Drug Administration's (FDA or Agency or we) Center for Devices and Radiological Health (CDRH or Center) is announcing its Ethylene Oxide Sterilization Master File Pilot Program (``EtO Pilot Program''). The EtO Pilot Program is voluntary and intends to allow companies (``sterilization providers'') that sterilize single- use medical devices using fixed chamber ethylene oxide (EtO) to submit a Master File when making certain changes between sterilization sites or when making certain changes to sterilization processes that utilize reduced EtO concentrations. Under this voluntary program, manufacturers (``PreMarket Application (PMA) holders'') of Class III devices subject to premarket approval that are affected by such changes may, upon FDA's permission, reference the Master File submitted by their sterilization provider in a postapproval report in lieu of submission of a premarket approval application (PMA) supplement. The EtO Pilot Program seeks to help ensure patient access to safe medical devices while encouraging new, innovative ways to sterilize medical devices that reduce the potential impact of EtO on the environment and on the public health while providing a regulatory approach that would address potential device shortages.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Submission for OMB Review; Child Care and Development Fund (CCDF) Tribal Annual Report-ACF-700 (0970-0430)
The Administration for Children and Families (ACF) is requesting a three-year extension of the form ACF-700: Child Care and Development Fund (CCDF) Tribal Annual Report (OMB #0970-0430, expiration 11/30/2019) with changes.
Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products; Guidance for Industry; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry entitled ``Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products.'' This guidance describes FDA's compliance policy for premarket review requirements for two types of limited modifications to new tobacco products that were on the market as of August 8, 2016, specifically, modifications to battery-operated tobacco products solely to comply with UL 8139 and modifications to liquid nicotine products solely to comply with the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA) flow restrictor requirements for liquid nicotine containers. This guidance will enable tobacco manufacturers to upgrade their battery-operated tobacco products to UL 8139. It will also enable manufacturers to comply with the CNPPA requirements for flow restrictors for liquid nicotine containers. FDA is issuing this guidance to address battery safety concerns and youth exposure to liquid nicotine toxicity.
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