Department of Health and Human Services October 13, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids
The Administration for Strategic Preparedness and Response is issuing this screening framework guidance, which sets forth baseline standards for the gene and genome synthesis industry, as well as best practices for all entities involved in the provision, use, and transfer of synthetic nucleic acids, regarding screening orders and recipients and maintaining records. In addition, this guidance seeks to encourage best practices to address biosecurity concerns associated with the potential misuse of synthetic nucleic acids in order to bypass existing regulatory controls and commit unlawful acts.
Biomedical Advanced Research and Development Authority Industry Day 2023
The Biomedical Advanced Research and Development Authority (BARDA) annually hosts BARDA Industry Day (BID), a two-day conference with industry and our government partners to share BARDA's goals and objectives, increase awareness of U.S. government medical countermeasure (MCM) priorities, and facilitate collaboration between public and private sectors within the health security space. This year, BARDA plans to discuss implementation efforts for our 2022-2026 Strategic Plan, which focuses on strengthening the health security of the nation, embracing lessons learned from the COVID-19 pandemic, incorporating new avenues of promising research and development, and addressing the imperative for MCMs that are safe, effective, and widely accessible.
Kerry Ingredients and Flavours Ltd.; Filing of Food Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Kerry Ingredients and Flavours Ltd., proposing that the food additive regulations be amended to provide for the safe use of vitamin D3 as a nutrient supplement in powdered drink mixes added to water or carbonated water, excluding drinks or drink mixes that are specially formulated or processed for infants.
Kerry Inc.; Filing of Food Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Kerry, Inc., proposing that the food additive regulations be amended to provide for the safe use of sodium alginate as a stabilizer and thickener in plant protein products at a level not to exceed 3 percent.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Recall Regulations
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA Recall Regulations.
Quality Considerations for Topical Ophthalmic Drug Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Quality Considerations for Topical Ophthalmic Drug Products.'' This draft guidance discusses certain quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye. Specifically, this draft guidance discusses approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation products; use of in vitro drug release/dissolution testing as an optional quality control strategy for certain ophthalmic dosage forms; recommendations for design and delivery and dispensing features of container closure systems; and recommendations for stability studies. The draft guidance applies to ophthalmic drug products approved under new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), as well as to over-the-counter (OTC) monograph drugs.
Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled ``Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry.'' The guidance document updates the current version of the guidance by including three additional questions. One question relates to any effect systems recognition or equivalency determinations have on prior notice requirements. The other two questions relate to FDA's notice to a submitter or transmitter of prior notice of an FDA refusal for inadequate prior notice or hold, if the food article is from a foreign facility that is not registered and addresses the timeframe for making requests for FDA review of such refusal or hold. FDA is also making other technical editorial changes. The guidance announced in this notice finalizes the draft guidance of the same title dated September 13, 2022.
Proposed Information Collection Activity; Tribal Child Support Enforcement Direct Funding Request: (Office of Management and Budget #0970-0218)
The Office of Child Support Services (OCSS), Administration for Children and Families (ACF) is requesting proposed revisions to an approved information collection the Tribal Child Support Enforcement Direct Funding Requests(Office of Management and Budget (OMB) #0970- 0218, expiration March 31, 2026). We are proposing a new requirement for tribes or tribal organizations to provide that charging fees and recovering costs will not be permitted.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importation of Prescription Drugs
The Food and Drug Administration (FDA or we) 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.
Submission for Office of Management and Budget Review; Evaluation of Resources To Support the Identification and Care of Children With Prenatal Substance or Alcohol Exposure in the Child Welfare System (Office of Management and Budget #0970-0608)
The Children's Bureau (CB), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is proposing to collect data for an evaluation of a set of resources that are being developed to support the identification and care of children with prenatal substance or alcohol exposure in the child welfare system.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
