Department of Health and Human Services August 13, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 18 of 18
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Teaching Health Center Graduate Medical Education Program Cost Evaluation, OMB No. 0906-XXXX-NEW
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.
New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation; Public Workshop; Request for Comments
The Food and Drug Administration (FDA or the Agency) is announcing the following public workshop entitled ``New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation.'' The purpose of the public workshop is to seek public comments/feedback on the Integrated Review documentation generated by the new Integrated Assessment of marketing applications for new drug products developed as part of the New Drugs Regulatory Program Modernization. The Agency hopes to receive public feedback on how this Integrated Review documentation can continue supporting our stakeholders' needs. Please see information and examples relevant to the Integrated Review at https://wcms-internet.fda.gov/drugs/news- events-human-drugs/integrated-assessment-marketing-applicatio ns- workshop-10302020-10302020.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Humanitarian Use Devices
The Food and Drug Administration (FDA or Agency) 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 information collection requirements for humanitarian use devices (HUDs).
Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment.'' This draft guidance is intended to assist sponsors in the clinical development of drugs and biological products for the treatment of acute myeloid leukemia (AML). This draft guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for the development of drugs and biological products to support an indication of treatment of AML, including indications limited to an individual phase of treatment (for example, maintenance, transplantation preparative regimen, etc.). The draft guidance addresses the topics of general drug development, efficacy endpoints, and exploratory and confirmatory trial considerations for AML drug development. In addition, the draft guidance addresses investigational new drug applications, new drug applications, and biologics licensing applications for AML drugs.
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures
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 requirements governing the acceptance of electronic records and electronic signatures.
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 a proposed information collection entitled ``Drug Overdose Response Investigation (DORI) Data Collections.'' CDC will use the information collected to respond to urgent requests from state and local health authorities to provide epidemiological information that allows for the selection of interventions to curb local epidemics of drug overdose.
Prospective Grant of an Exclusive Start-Up Patent License for Evaluation: Immunotherapy for Relapsed/Refractory Diffuse Large B Cell Lymphoma
The National Heart, Lung, and Blood Institute, of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive start-up patent license for evaluation to ONK Therapeutics, a start-up company spun-off from the National University of Ireland Galway, and incorporated under the laws of the Republic of Ireland, to practice, for a limited time, the inventions covered by the patent estate listed in the Supplementary Information section of this notice. Upon expiration of the evaluation period the granted licenses may be converted into a fully exclusive patent commercialization license for the term of the last to expire of the patent estate upon the company providing NHLBI with a commercial development plan supporting such a conversion. This notice is intended to apprise the public of a aforementioned license and provide a fifteen (15) day notice period for the objection.
Meeting of the the Substance Abuse and Mental Health Services Administration's National Advisory Council
Notice is hereby given of the meeting on September 3, 2020, of the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Advisory Council (SAMHSA NAC). The meeting is open to the public and can only be accessed virtually. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/advisory-councils/meetings. The meeting will include remarks and discussion with the Assistant Secretary for Mental Health and Substance Use; updates on SAMHSA priorities and initiatives, and a council discussion on clinical trends and emerging national issues with SAMHSA NAC members.
Submission for OMB Review; Youth Empowerment Information, Data Collection, and Exploration on Avoidance of Sex (IDEAS) (New Collection)
The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), proposes survey data collection activities as part of the Youth Empowerment IDEAS study.
Basic Health Program; Federal Funding Methodology for Program Year 2021
This document finalizes the methodology and data sources necessary to determine federal payment amounts to be made for program year 2021 to states that elect to establish a Basic Health Program under the Patient Protection and Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges.
Awards Unsolicited Proposal for the Health Communication Initiative Program
The Office of Clinical and Preventive Services (OCPS) announces the award of a single-source cooperative agreement in response to an unsolicited proposal from Johns Hopkins University, Baltimore, Maryland. The proposal submitted was not solicited either formally or informally by any federal government official. OCPS performed an objective review of the unsolicited proposal from Johns Hopkins University (JHU) to develop information on proper actions to mitigate the spread of COVID-19, in a culturally sensitive way. The Johns Hopkins Bloomberg School of Public Health (JHSPH) Center for American Indian Health (CAIH) mission is to work in partnerships with AI/AN communities to raise their health status, self-sufficiency, and health leadership to the highest possible level. This mission is accomplished through research, training and education, and service. The CAIH has more than nine facilities and approximately 100 staff in the Southwestern tribal communities to assist the Indian Health Service (IHS) in containing and mitigating COVID-19, while building a response model and set of communication materials for all IHS regions nationwide. The CAIH can draw on broad expertise from JHU for additional guidance and recommendations on best practices as the situation evolves. The materials will be developed from the Centers for Disease Control and Prevention (CDC) and the Substance Abuse and Mental Health Services Administration (SAMHSA) guidance. Based on an internal review of the proposal and the immediate response of the IHS to address the COVID-19 public health emergency, OCPS determined that the proposal has merit. The long history between the federal government and Native American Tribes and people has often been less than ideal. There are still barriers to the Native American community accepting instruction or direction from the federal government. There is great value in having a third party that has a good history with the community to gather, package and deliver recommendations, in a culturally sensitive way, on staying safe from this disease, when those recommendations may run contrary to cultural norms. This delivery avenue will be more acceptable to the community, and will be more readily recognized for implementation within AI/AN communities. This award is being made noncompetitively because there is no current, pending, or planned funding opportunity announcement under which this proposal could be competed. OCPS has identified two additional key reasons to support rationale for awarding this unsolicited proposal: 1. The JHU CAIH is well known in the AI/AN communities for robust communication/messaging networks, research, training, and subject matter expertise. The dissemination of critical COVID-19 information for tribal communities builds trust, credibility, and integrity of promoting a culturally sensitive public health approach around the information. 2. The JHU CAIH is uniquely positioned to provide culturally specific subject matter expertise drawn from a direct care services or ``boots on the ground'' approach. The CAIH has nearly 40 years of collaboration with Native American tribes and supports public health interventions in more than 140 tribal communities in over 21 states. The breadth of knowledge and existing partnerships will enhance dissemination of information nationally. Legislative Authority: The Snyder Act, 25 U.S.C. Section 13; the Indian Health Care Improvement Act, 25 U.S.C. Section 1621b; and Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136.
Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods
The Food and Drug Administration (FDA or we) is issuing a final rule to establish requirements concerning ``gluten-free'' labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These requirements f are needed to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to fermented or hydrolyzed foods labeled as ``gluten- free.'' Currently, FDA knows of no scientifically valid analytical method effective in detecting and quantifying with precision the gluten protein content in fermented or hydrolyzed foods in terms of equivalent amounts of intact gluten proteins. Thus, we plan to evaluate compliance of such fermented or hydrolyzed foods that bear a ``gluten-free'' claim based on records that are made and kept by the manufacturer of the food bearing the ``gluten-free'' claim and made available to us for inspection and copying. The records need to provide adequate assurance that the food or ingredients used in the food are ``gluten-free'' before fermentation or hydrolysis. Once we identify that a scientifically valid method has been developed that can accurately detect and quantify gluten in fermented or hydrolyzed foods or ingredients, it would no longer be necessary for the manufacturer of foods bearing the ``gluten-free'' claim to make and keep these records. In addition, because currently there is no scientifically valid analytical method effective in detecting and quantifying the gluten protein content in fermented or hydrolyzed foods the final rule requires the manufacturer of these kinds of foods bearing the ``gluten- free'' claim to document that it has adequately evaluated the potential for gluten cross-contact and, if identified, that the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process. Likewise, the final rule requires manufacturers of foods that contain fermented or hydrolyzed ingredients and bear the ``gluten-free'' claim to make and keep records that demonstrate with adequate assurance that the fermented or hydrolyzed ingredients are ``gluten-free'' in compliance with the 2013 gluten-free food labeling final rule. Finally, this final rule states that we will evaluate compliance of distilled foods by verifying the absence of protein using scientifically valid analytical methods that can reliably detect the presence of protein or protein fragments in the distilled food.
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