Department of Health and Human Services 2024 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Proposed Collection; Comment Request; Interstate Shellfish Dealer's Certificate and Participation in the National Shellfish Sanitation Program
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 the information collection provisions of the Interstate Shellfish Dealer's Certificate as well as the collection of other records related to participation in the National Shellfish Sanitation Program (NSSP).
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additives Intended for Use in Animal Food, Food Additive Petitions, Investigational Food Additive Files Exemptions, and Declaration on Animal Food Labels
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 the information collection provisions associated with food additives intended for use in animal food, food additive petitions, investigational food additive files exemptions, and declaration of color additives on animal food labels.
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.
Notice of Meetings
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group (IRG) Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will be closed to the public.
Determination of Regulatory Review Period for Purposes of Patent Extension; BYLVAY
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BYLVAY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; SOHONOS
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SOHONOS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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.
Fiscal Year 2025 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments
The Food and Drug Administration (FDA or the Agency) is announcing the following public workshop entitled "FY 2025 Generic Drug Science and Research Initiatives Workshop." The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of interested partiesindustry, academia, patient advocates, professional societies, and other interested partiesas it fulfills its commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its fiscal year (FY) 2026 Generic Drug User Fee Amendments (GDUFA) science and research initiatives.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Advanced Manufacturing Technologies Designation Program
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 (PRA).
The National Institutes of Health Public Access Policy
The 2024 National Institutes of Health (NIH) Public Access Policy implements additional steps to accelerate free public access to scholarly publications resulting from the research that NIH supports, building upon NIH's long history of providing public access to research results.
Health Data, Technology, and Interoperability: Protecting Care Access
This final rule has finalized certain proposals from the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability Proposed Rule (HTI-2 Proposed Rule) and in doing so supports the access, exchange, and use of electronic health information. Specifically, this final rule amends the information blocking regulations to revise two existing information blocking exceptions and establish an additional reasonable and necessary activity that does not constitute information blocking referred to as the Protecting Care Access Exception.
Notice of Proposed Purchased/Referred Care Delivery Area Redesignation for the Chippewa Cree Tribe of the Rocky Boy's Reservation
This Notice advises the public that the Indian Health Service (IHS) proposes to expand the geographic boundaries of the Purchased/ Referred Care Delivery Area (PRCDA) for the Chippewa Cree Tribe of the Rocky Boy's Reservation ("Chippewa Cree Tribe" or "Tribe") to include the Montana county of Cascade. The current PRCDA for the Chippewa Cree Tribe includes the Montana counties of Choteau, Hill and Liberty. Chippewa Cree Tribal members who reside outside of the PRCDA are eligible for direct care services; however, they are not eligible for Purchased/Referred Care (PRC) services. The sole purpose of this expansion would be to authorize additional Chippewa Cree Tribal members and beneficiaries to receive PRC services.
Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins
This rule finalizes updates to the HHS list of select agents and toxins that could pose a severe threat to public health and safety. These updates were proposed along with other changes to the select agent and toxin regulations, which will be addressed in a separate regulatory action. In a companion document published in this issue of the Federal Register, the U.S. Department of Agriculture (USDA) is making parallel regulatory changes.
Expansion of NIOSH B Reader Certification Eligibility; Request for Information
The B Reader Program, administered by CDC's National Institute for Occupational Safety and Health (NIOSH), is seeking information from experts in occupational respiratory health surveillance and radiology, nurse practitioners, physician assistants, workers exposed to mineral dust and unions representing such workers, industry and other parties interested in allowing nurse practitioners and physician assistants to be eligible to take the NIOSH B Reader examination and become certified B Readers if they successfully pass the examination.
Solicitation of Nominations for Appointment to the Clinical Laboratory Improvement Advisory Committee
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Clinical Laboratory Improvement Advisory Committee (CLIAC). CLIAC, consisting of up to 20 members including the Chair, represents a diverse membership across laboratory specialties, professional roles (laboratory management, technical specialists, physicians, nurses), and practice settings (academic, clinical, public health), and includes a consumer representative.
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request; Correction
On December 9, 2024, CMS published a notice in the Federal Register that sought comment on a collection of information concerning CMS-2088-17 (OMB control number 0938-0037) entitled "Community Mental Health Center Cost Report." The OMB control number identifying the aforementioned information collection request is incorrectly listed in the SUPPLEMENTARY INFORMATION section of the notice. This document corrects the error.
Proposed Collection; 60-Day Comment Request; The Genetic Testing Registry (Office of the Director)
In compliance with the requirements of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health Office (NIH) of the Director (OD) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Fiscal Year (FY) 2024 Notice of Reissued Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Service Administration plans to withdraw the previously announced notice of funding opportunity (NOFO) for the Women's Behavioral Health Technical Assistance Center SM-24-012 and reissue the NOFO as the National Women's Behavioral Health Technical Assistance Center SM-25-014. The revised NOFO includes updates to the required activities and application evaluation criteria. The cancellation of NOFO SM-24-012 does not represent an assessment of the technical merits of any applications submitted. SAMHSA will notify organizations that submitted an application.
Notice of Proposed Purchased/Referred Care Delivery Area Redesignation for the Shoshone-Bannock Tribes
This Notice advises the public that the Indian Health Service (IHS) proposes to expand the geographic boundaries of the Purchased/ Referred Care Delivery Area (PRCDA) for the Shoshone-Bannock Tribes of the Fort Hall Indian Reservation in Idaho to include the Idaho counties of Ada, Bear Lake, Blaine, Bonneville, Butte, Canyon, Cassia, Custer, Elmore, Franklin, Fremont, Gem, Gooding, Jefferson, Jerome, Madison, Minidoka, Oneida, Payette, Teton, Twin Falls, and Washington. The current PRCDA for the Shoshone-Bannock Tribes includes the Idaho counties of Bannock, Bingham, Caribou, Lemhi, and Power. Shoshone- Bannock Tribal members who reside outside of the PRCDA are eligible for direct care services; however, they are not eligible for Purchased/ Referred Care (PRC) services. The sole purpose of this expansion would be to authorize additional Shoshone-Bannock Tribal members and beneficiaries to receive PRC services.
Reimbursement Rates for Calendar Year 2025
Notice is provided that the Director of the Indian Health Service (IHS) has approved the rates for inpatient and outpatient medical care provided by the IHS facilities for Calendar Year 2025.
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 for Nominations for Members of the U.S. Preventive Services Task Force
The Agency for Healthcare Research and Quality invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF).
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