Department of Health and Human Services March 25, 2024 – Federal Register Recent Federal Regulation Documents
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Meetings of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that an in-person meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The meeting will be open to the public as well as streamed live on hhs.gov/live. A pre-registered public comment and innovation spotlight session will be held during the meeting. Pre-registration is required for members of the public who wish to present their comments or innovations live during the meeting. Individuals who wish to send in their written public comment should send an email to CARB@hhs.gov. Registration information is available on the website https:// www.hhs.gov/paccarb and must be completed by May 16, 2024, to attend the May 21-22, 2024, public meeting or by May 14, 2024, to provide live comments at the meeting. Additional information about registering for the meeting and providing public comment can be obtained at https:// www.hhs.gov/ paccarb on the Upcoming Meetings page.
Medicare Program; Virtual Meeting of the Medicare Evidence Development and Coverage Advisory Committee-May 21, 2024
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)).
Notice of Award of a Single Source Cooperative Agreement 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)
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.
Submission for OMB Review; 30-Day Comment Request; Cancer Therapy Evaluation Program (CTEP) Branch and Support Contracts Forms and Surveys (NCI); Correction
In compliance with the requirement of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Fiscal Year (FY) 2024 Funding Opportunity
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.
Request for Information: Elder Justice Coordinating Council Priorities
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.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; ACL Program Performance Report Generic Information Collection, OMB Control Number 0985-NEW
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 ACL Program Performance Report Generic Information Collection, OMB 0985-NEW.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; of the Independent Living Services (ILS) Program Performance Report (PPR) OMB Control Number 0985-0043
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.
Submission for Office of Management and Budget Review; Grants to States for Access and Visitation (Office of Management and Budget #: 0970-0204)
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.
Martin Valdes: Final Debarment Order
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Martin Valdes, M.D., from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Valdes was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. Dr. Valdes was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why he should not be debarred. As of January 7, 2023 (30 days after receipt of the notice), Dr. Valdes had not responded. Dr. Valdes's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.
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 (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.
Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections; Correction
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.
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