Department of Health and Human Services October 2023 – Federal Register Recent Federal Regulation Documents
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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.
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.
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.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2023
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published in the 3-month period, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities.'' FDA is issuing this draft guidance to describe how we request and conduct voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, compounded, or held, and at facilities covered under FDA's bioresearch monitoring program. FDA may consider the use of a remote interactive evaluation for any of the inspection program areas described in the guidance. FDA is also announcing the withdrawal of the guidance entitled ``Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency.''
Agency Information Collection Activities; Proposed Collection; Comment Request; State Health Insurance Assistance Program (SHIP) Client Contact Forms OMB Control Number 0985-0040
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a 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 the proposed Revision for the information collection requirements related to the State Health Insurance Assistance Program (SHIP) Client Contact Forms OMB Control Number 0985-0040.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Consumer Assessment of Healthcare Providers and Systems (CAHPS) Health Plan Survey Database.'' This proposed information collection was previously published in the Federal Register on August 24, 2023, and allowed 60 days for public comment. AHRQ received no substantive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
National Biodefense Science Board Public Meeting
The National Biodefense Science Board (NBSB) will publicly meet using an online format on Thursday, November 30, 2023 (12:30 to 4:00 p.m. ET). Notice of the meeting is required under section 10(a)(2) of the Federal Advisory Committee Act (FACA). The NBSB provides expert advice and guidance to the U.S. Department of Health and Human Services (HHS) regarding current and future chemical, biological, radiological, and nuclear threats, as well as other matters related to disaster preparedness and response. The Administration for Strategic Preparedness and Response (ASPR) manages and convenes the NBSB on behalf the Secretary of HHS. The NBSB will discuss and vote on two sets of recommendations related to COVID-19 pandemic lessons, Project NextGen vaccine and therapeutic products, and disaster preparedness training. Procedures for Public Participation: The public and expert stakeholders are invited to observe the meeting. Pre-registration (Zoom) is required. Anyone may submit questions and comments to the NBSB by email (NBSB@hhs.gov) before the meeting. American Sign Language translation and Communication Access Real-Time Translation will be provided. Representatives from industry, academia, health professions, health care consumer organizations, non-federal government agencies, or community-based organizations may request up to seven minutes to speak directly to the Board. Requests to speak to the Board will be approved in consultation with the Board Chair and based on time available during the meeting. Requests to speak to the NBSB during the public meeting must be sent to NBSB@hhs.gov by close of business on November 23, 2023. Please provide the full name, credentials, official position(s), and relevant affiliations for the speaker and a brief description of the intended topic. Presentations that contain material with a commercial bias, advertising, marketing, or solicitations will not be allowed. A meeting summary will be available on the NBSB website post-meeting.
Agency Information Collection Activities; Proposed Collection; Comment Request; Title VI Program Performance Report (OMB Control Number 0985-0007)
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995, Federal agencies are required to publish a 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 a proposed extension without change information collection and solicits comments on the information collection requirements related to the Title VI Program Performance Report (OMB Control Number 0985-0007).
Agency Information Collection Activities; Proposed Collection; Comment Request; Export Certificates for Food and Drug Administration Regulated Products
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 export certificates for FDA regulated products.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Standardized Reporting Forms for Food and Drug Administration Federally Funded Public Health Projects and Agreements
The Food and Drug Administration (FDA, Agency, 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.
Findings of Research Misconduct
Findings of research misconduct have been made against Lara S. Hwa, Ph.D. (Respondent), who is an Assistant Professor, Department of Psychology and Neuroscience, Baylor University (BU), and formerly was a Postdoctoral Fellow, School of Medicine, University of North Carolina at Chapel Hill (UNC-CH). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH), grants K99/R00 AA027576, T32 AA007573, F31 AA027129, F32 AA026485, R01 AA019454, U01 AA020911, R01 AA025582, and P60 AA011605 and included in two grant applications submitted for PHS funds, specifically K99 AA027576 submitted to NIAAA, NIH, and R01 DK136486 submitted to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH. The administrative actions, including supervision for a period of four (4) years, were implemented beginning on August 24, 2023, and are detailed below.
Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Revised Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.'' This revised draft guidance, when finalized, will provide FDA's current thinking on common questions regarding certain communications by firms to health care providers (HCPs) of scientific information on unapproved use(s) of approved/ cleared medical products (the scope of the italicized terms is further explained in the revised draft guidance). This revised guidance supersedes the revised draft guidance entitled ``Distributing Scientific and Medical Publications on Unapproved New UsesRecommended Practices'' issued in 2014 (2014 revised draft guidance).
Notice of Request for Public Comment on Proposed Update to the Bright Futures Periodicity Schedule as Part of the HRSA-Supported Preventive Services Guidelines for Infants, Children, and Adolescents
This notice seeks public comment on a proposed update to the Periodicity Schedule of the Bright Futures Recommendations for Pediatric Preventive Health Care (``Bright Futures Periodicity Schedule''), as part of the HRSA-supported preventive services guidelines for infants, children, and adolescents.
Title IV-E Prevention Services Clearinghouse Handbook of Standards and Procedures, Draft Version 2.0
The Administration for Children and Families (ACF), within the U.S. Department of Health and Human Services (HHS), oversees the Title IV-E Prevention Services Clearinghouse. ACF seeks comments on proposed changes and clarifications to existing standards and procedures in the Handbook of Standards and Procedures, Version 2.0.
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