Department of Health and Human Services 2023 – Federal Register Recent Federal Regulation Documents
Results 501 - 550 of 3,523
Prior Notice: Adding Requirement To Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-Refusal and Post-Hold Submissions
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its prior notice regulations to add a requirement that the prior notice for articles of food arriving by international mail include the name of the mail service and a mail tracking number and add a requirement that prior notice and food facility registration information be submitted within a certain timeframe, after certain notices of refusal or hold have been issued (``post-refusal'' and ``post-hold'' submission). We are also proposing certain technical changes, including those that reflect expanded capabilities of the Automated Broker Interface/Automated Commercial Environment/ International Trade Data System (ABI/ACE/ITDS) and the Prior Notice Systems Interface (PNSI). These amendments, if finalized, will improve program efficiency and better enable FDA to protect the U.S. food supply and public health.
Privacy Act of 1974; Matching Program
In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of the re-establishment of a computer matching program between CMS and the Department of Defense, Defense Manpower Data Center for ``Verification of Eligibility for Minimum Essential Coverage Under the Patient Protection and Affordable Care Act through a Department of Defense Health Benefits Plan.''
Meeting of the Advisory Committee on Infant and Maternal Mortality; Correction
HRSA published a notice in the Federal Register of October 12, 2023, concerning a meeting of the Advisory Committee on Infant and Maternal Mortality. The document contained incorrect location information. The notice originally stated that the meeting would be held in person at HRSA Headquarters (5600 Fishers Lane, Room 5W07, Rockville, Maryland, 20857) and virtually via webinar. The meeting will now be fully virtual via webinar and not held in person. The webinar link and log-in information will be available at the Committee's website before the meeting: https://www.hrsa.gov/advisory-committees/ infant-mortality/.
Fiscal Year (FY) 2024 Notice of Supplemental Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting a supplement in scope of the original award to the Community-Based, Advocacy-Focused, Data-Driven, Coalition-Building Association (CADCA) recipient funded in FY 2019 under the National Anti-Drug Coalitions Training and Workforce Development Grant Program (Short Title: Coalitions Training Grant), Notice of Funding Opportunity (NOFO) SP-19- 002. The recipient may receive up to $562,500. The supplemental funding will extend the project period by 10-months until September 29, 2024 and will: leverage existing resources and conference support to expand SAMHSA's scope and capacity; and 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. The training and workforce development activities supported through this grant include SAMHSA's Prevention Day and SAMHSA's participation in the annual National Leadership Forum and annual Mid- Year Training Institute of CADCA.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).
Supplemental Evidence and Data Request on Healthcare Delivery of Clinical Preventive Services for People With Disabilities
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 Healthcare Delivery of Clinical Preventive Services for People with Disabilities, 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.
21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking
This proposed rule would implement the provision of the 21st Century Cures Act specifying that a health care provider determined by the HHS Inspector General to have committed information blocking shall be referred to the appropriate agency to be subject to appropriate disincentives set forth through notice and comment rulemaking. In particular, this rulemaking would establish for such health care providers a set of appropriate disincentives using authorities under applicable Federal law.
David Winne: Grant of Special Termination; Final Order Terminating Debarment
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) granting special termination of the debarment of David Winne with an effective date of August 18, 2024. FDA bases this order on a finding that Mr. Winne provided substantial assistance in the investigations or prosecutions of offenses relating to a matter under FDA's jurisdiction, and that special termination of Mr. Winne's debarment serves the interest of justice and does not threaten the integrity of the drug approval process.
Determination of Regulatory Review Period for Purposes of Patent Extension; Omegaven
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Omegaven and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee
The Food and Drug Administration (FDA or the Agency) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee (MDAC or the Committee) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on certain device panels of the MDAC in the CDRH. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current and upcoming vacancies effective with this notice.
Determination That CALCIUM DISODIUM VERSENATE (Edetate Calcium Disodium) Injection, 200 Milligrams per Milliliter, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Proposed Collection; 60-Day Comment Request; NIH Office of Intramural Training & Education-Application, Registration, and Alumni Systems Office of the Director
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) Office of Intramural Training & Education (OITE) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Privacy Act of 1974; System of Records
In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is establishing a new system of records maintained by the Indian Health Service (IHS) Office of Clinical and Preventive Services (OCPS), System Number 09-17-0006, ``Community Health Aide Program (CHAP) Records.'' The records in the new system of records are about individual healthcare providers who have applied for Federal certification under the Community Health Aide Program (CHAP) created under the Indian Health Care Improvement Act, as amended; and individuals serving as CHAP Certification Board members who review and evaluate the certification/recertification applications for completeness and verify that the candidates meet the minimum standards for certification. The CHAP Certification Board will provide the respective Area Director with its recommendation to either certify, recertify, or deny certification after reviewing the certification applications.
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.
World Trade Center Health Program; Youth Research Cohort; Request for Information
CDC's National Institute for Occupational Safety and Health (NIOSH) is extending the public comment period for a request for information (RFI) that was initially published April 26, 2023 and extended on August 18, 2023, regarding a World Trade Center (WTC) Health Program research cohort for future studies on health, social, and educational impacts among persons exposed to the September 11, 2001, terrorist attacks who were aged 21 years or younger at the time of their exposures. With this notice, the comment period is extended an additional 90 days to allow interested parties additional time to respond.
Request for Public Comment: 30-Day Information Collection: Application for Participation in the IHS Scholarship Program
In compliance the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``Application for Participation in the IHS Scholarship Program,'' Office of Management and Budget (OMB) Control No. 0917-0006. IHS is requesting OMB to approve an extension for this collection, which expires on October 31, 2023.
Charter Renewal for the National Advisory Committee on Rural Health and Human Services
In accordance with the Federal Advisory Committee Act, HHS is hereby giving notice that the National Advisory Committee on Rural Health and Human Services (NACRHHS or Committee) has been renewed. The effective date of the renewed charter is October 29, 2023.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Division of Workforce Development (DWD) Fellowship Alumni Assessment. Information will be collected from graduates of selected public health fellowships to assess the impact of fellowship programs and improve their management.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Pulmonary Function Testing Course Approval Program. The program consists of an application submitted by potential sponsors universities, hospitals, and private consulting firms, who seek NIOSH approval to conduct courses, and if approved, notification to NIOSH of any course or faculty changes during the approval period, which is limited to five years.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled IRB Authorization Agreement for Human Research. The purpose of the data collection is to keep track of, and provide regulatory oversight for, those institutions that have elected to rely on the CDC IRB's review of research studies.
Proposed Information Collection Activity; Survey on Where Parents Look for and Find Information and How They Use Information When Selecting Child Care (New Collection)
The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) is proposing to collect nationally representative survey data to learn more about where parents look for and find information about Child Care and Early Education (CCEE); how parents assess the people, places, or things that may offer CCEE information; what types of CCEE information parents look for; and how parents use information to select CCEE. The study aims to gather information that may be used by Child Care Lead Agencies to inform their consumer education efforts.
Medicaid and Children's Health Insurance Program (CHIP) Generic Information Collection Activities: Proposed Collection; Comment Request
On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low-burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit 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.
Reorganization of the Center for Mental Health Services
Statement of Organization, Functions, and Delegations of Authority. The Substance Abuse and Mental Health Services Administration has modified its structure. This new organizational structure was approved by the Secretary of Health and Human Services on October 11, 2023, and became effective on October 26, 2023.
Registration Requirements in the 340B Drug Pricing Program
HRSA is issuing this Notice to inform and remind stakeholders of the registration requirements for off-site, outpatient hospital facilities to participate in the 340B Drug Pricing Program (340B Program). This Notice applies to all hospital types that participate in the 340B Program.
Proposed Collection; 60-Day Comment Request; Collection of Grants and Contracts Data the Historically Black Colleges and Universities (HBCUs) and Small Businesses May Be Interested in Pursuing, (Office of the Director)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Institutes of Health, Office of the Director, Office of Acquisitions and Logistics Management, Small Business Program Office, will publish periodic summaries of existing projects to be submitted to the Office of Management and Budget for review and approval.
Health Information Technology Advisory Committee Schedule of Meetings
The Health Information Technology Advisory Committee (HITAC) was established in accordance with the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings for the remainder of 2023 and throughout 2024. See list of public meetings below.
Agency Information Collection Activities: Submission for OMB Review; 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 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.
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.
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