Department of Health and Human Services – Federal Register Recent Federal Regulation Documents

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Fiber Intake and Laxation Outcomes, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.

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.

This notice announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace[supreg], Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias (ADRD) on people with the disease and their caregivers. During the meeting on April 29 and April 30, 2024, the Advisory Council will hear updates from federal agencies on activities during the last quarter and from panels organized by the clinical care and long-term services and supports subcommittees. On the first day, presenters will discuss care and navigation across healthcare settings from post-diagnosis through advanced disease. The panels on the second day will focus on challenges with long-term services and supports for people with young-onset dementia and their care partners/families, as well as challenges with dementia among aging populations experiencing homelessness or incarceration.

The Food and Drug Administration (FDA or Agency) is announcing that a collection of information entitled ``Reporting and Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA).

The Food and Drug Administration (FDA, the Agency, or we) is proposing to ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB). FDA has determined these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. This proposal follows a court decision vacating a prior ban and amendment to the Federal Food, Drug, and Cosmetic Act clarifying our authority to ban a device for one or more intended uses. This action, if finalized, will mean ESDs for SIB and AB are adulterated and not legally marketed.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) for LYNPARZA (olaparib) Capsules, 50 milligrams (mg) held by AstraZeneca Pharmaceuticals LP (AZ), 1800 Concord Pike, Wilmington, DE 19803. AZ has voluntarily requested that FDA withdraw approval of this application and has waived its opportunity for a hearing.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

This notice announces a virtual public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Tuesday, May 21, 2024. The MEDCAC panel will consider which health outcomes in studies of devices for self- management of Type 1 and insulin-dependent Type 2 diabetes should be of interest to CMS. Given the increased emphasis on new and innovative medical products for difficult to manage conditions, some studies of new medical technologies have focused on short-term data with greater reliance on intermediate outcomes and surrogate endpoints. As a result, assessments of new medical technologies have more frequent evidence gaps with respect to clinically meaningful health outcomes for CMS beneficiaries. The MEDCAC panel will examine the growing challenges associated with the decreased level of evidence of certain new and innovative technologies. By voting on specific questions, and by their discussions, MEDCAC panel members will advise CMS about the ideal health outcomes in research studies of devices for diabetes self-management, appropriate measurement instruments and adequate follow-up durations to help to provide clarity and transparency in future National Coverage Analyses (NCAs). This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces 6 separate awards to fund White Mountain Apache Tribe (WMAT), San Carlos Apache Tribe (SCAT), Gila River Indian Community (GRIC), Navajo Nation (NN), Hopi Tribe and Tohono O'odham Nation (TON). Funding amounts will be determined on disease burden during 2010-2020. The total 5 year period amount for the (6) recipients is $1,800,000.00 The awards will address Rocky Mountain Spotted Fever (RMSF) prevention activities, including but not limited to vector control, outreach, and education, and RMSF prevention support services.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award up to $675,000 per year for up to five (5) years to the Community-Based, Advocacy-Focused, Data-Driven, Coalition-Building Association (CADCA). The purpose of the award is to leverage existing resources to expand SAMHSA's scope and prevention capacity; provide training and technical assistance to state and community prevention leaders, including members of anti-drug community coalitions from around the country who are committed to addressing the evolving needs of the behavioral health field; and to promote prevention workforce development. The training and workforce development activities supported through this cooperative agreement include SAMHSA's Prevention Day and SAMHSA's participation in the annual National Leadership Forum, the annual Mid-Year Training Institute of CADCA, and developing youth leaders across the three conferences/events listed above.

The Administration for Community Living (ACL) seeks information on recommended area(s) and or issue(s) for which elder justice stakeholders believe the Elder Justice Coordinating Council (Council) can be the most beneficial to promoting elder justice and have the greatest positive impact for survivors of elder abuse, neglect, and exploitation and their communities.

The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the Independent Living Services (ILS) Program Performance Report (PPR) OMB 0985-0043.

The Division of Program Innovation, Office of Child Support Services (OCSS), Administration for Children and Families (ACF) is requesting a 3-year extension of the Access and Visitation Survey: Annual Report (Office of Management and Budget #: 0970-0204, expiration 6/30/2024). There are no changes requested to the form.

HHS published a document in the Federal Register of March 12, 2024, announcing the Presidential Advisory Council on HIV/AIDS (PACHA) 80th full council meeting. Due to unforeseen circumstances, there has been an update in meeting location.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled The National Firefighter Registry (NFR) for Cancer. In accordance with the Firefighter Cancer Registry Act of 2018, the NFR will maintain a voluntary registry of firefighters to collect relevant health and occupational information of such firefighters for purposes of determining cancer incidence.

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this Notice to Poolbeg Pharma (UK) Limited, incorporated in the United Kingdom.

The Food and Drug Administration (FDA, we, or the Agency) is extending the comment period for two chapters of a multichapter draft guidance entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry,'' which were announced in the Federal Register of September 27, 2023. The relevant draft chapters are entitled ``Chapter 11 Food Allergen Program'' and ``Chapter 16Acidified Foods.'' We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments before FDA begins work on the final guidance.