{"description":"Documents matching 'require certain breast density information'","count":549,"total_pages":28,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=require+certain+breast+density+information&format=json&page=2","results":[{"title":"Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide; Guidance for Industry and Food and Drug Administration Staff; Availability","type":"Rule","abstract":"The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled \"Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide.\" The Mammography Quality Standards Act of 1992 (MQSA) final rule amended FDA's regulations to address, among other things, standards for accreditation bodies, certifying agencies, mammography equipment, quality assurance testing, and clinical image quality, as well as to require certain breast density information be provided by mammography facilities to patients and their healthcare providers. The small entity compliance guide (SECG) is intended to help small entities comply with the MQSA final rule.","document_number":"2024-19059","html_url":"https://www.federalregister.gov/documents/2024/08/26/2024-19059/mammography-quality-standards-act-and-regulation-amendments-small-entity-compliance-guide-guidance","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-26/pdf/2024-19059.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-19059.pdf?1724417123","publication_date":"2024-08-26","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"comment does not include any confidential <span class=\"match\">information</span> that you or a third party may not wish to be posted, such as medical <span class=\"match\">information</span>, your or anyone else's Social Security number, or confidential business <span class=\"match\">information</span>, such as a manufacturing process. Please note that if you include your name, contact <span class=\"match\">information</span>, or other <span class=\"match\">information</span> that identifies you in the body of your comments, that <span class=\"match\">information</span> will be posted on \n https://www.regulations.gov. \n \n • If you want to submit a comment with confidential <span class=\"match\">information</span> that you do not wish to be made available"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Standards Quality Act Requirements","type":"Notice","abstract":"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 information collection associated with the Mammography Quality Standards Act.","document_number":"2025-22276","html_url":"https://www.federalregister.gov/documents/2025/12/09/2025-22276/agency-information-collection-activities-proposed-collection-comment-request-mammography-standards","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-09/pdf/2025-22276.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-22276.pdf?1765201509","publication_date":"2025-12-09","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"comment does not include any confidential <span class=\"match\">information</span> that you or a third party may not wish to be posted, such as medical <span class=\"match\">information</span>, your or anyone else's Social Security number, or confidential business <span class=\"match\">information</span>, such as a manufacturing process. Please note that if you include your name, contact <span class=\"match\">information</span>, or other <span class=\"match\">information</span> that identifies you in the body of your comments, that <span class=\"match\">information</span> will be posted on \n https://www.regulations.gov. \n \n • If you want to submit a comment with confidential <span class=\"match\">information</span> that you do not wish to be made available"},{"title":"Medicare and Medicaid Programs; Hospital Condition of Participation: Prohibiting Sex-Rejecting Procedures for Children","type":"Proposed Rule","abstract":"This proposed rule would revise the requirements that Medicare and Medicaid certified hospitals must meet to participate in the Medicare and Medicaid programs. These changes are necessary to protect the health and safety of children and reflect HHS' review of recent information on the safety and efficacy of sex-rejecting procedures (SRPs) on children. The revisions to the requirements would prohibit hospitals from performing sex-rejecting procedures on children.","document_number":"2025-23465","html_url":"https://www.federalregister.gov/documents/2025/12/19/2025-23465/medicare-and-medicaid-programs-hospital-condition-of-participation-prohibiting-sex-rejecting","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-19/pdf/2025-23465.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-23465.pdf?1766065528","publication_date":"2025-12-19","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"Collection of <span class=\"match\">Information</span> Requirements \n \n Under the Paperwork Reduction Act of 1995, we are <span class=\"match\">required</span> to provide 60-day notice in the \n Federal Register \n and solicit public comment before a collection of <span class=\"match\">information</span> requirement is submitted to the Office of Management and Budget (OMB) for review and approval. To fairly evaluate whether an <span class=\"match\">information</span> collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 <span class=\"match\">requires</span> that we solicit comment on the following issues:\n \n • The need for the <span class=\"match\">information</span> collection"},{"title":"Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; Including the Hospital Outpatient Quality Reporting Program and Ambulatory Surgical Center Quality Program; Request for Information on Strengthening the Standardization and Comparability of Hospital Price Transparency (HPT) Data; Prior Authorization; Accrediting Organization (AO) Deeming for Emergency Medical Treatment and Labor Act (EMTALA); and Notices of Closure of Teaching Hospitals and Opportunities To Apply for Available Slots","type":"Proposed Rule","abstract":"This proposed rule would revise the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2027 based on our continuing experience with these systems. We also describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment systems. In addition, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting Program and the Ambulatory Surgical Center Quality Reporting Program. There are no changes to the Rural Emergency Hospital Quality Reporting Program. We propose to expand the prior authorization requirement to include additional Botulinum Toxin Injection services. We also propose to implement certain provisions of the Consolidated Appropriations Act, 2026, for off-campus outpatient departments of a provider. In addition, this proposed rule announces notices of closure of teaching hospitals and opportunities to apply for available slots. This rule also requests information regarding potential approaches to improve comparability and standardization, particularly for complex contracting methodologies, of the HPT information reported in machine- readable files and consumer-friendly displays. We propose hospital AOs with deeming authority to assess compliance with certain Emergency Medical Treatment and Labor Act (EMTALA) administrative requirements during accreditation and reaccreditation surveys. Finally, we are soliciting comments on a potential separate payment under the Inpatient Prospective Payment System (IPPS) for domestic procurement of personal protective equipment and essential medicines.","document_number":"2026-13656","html_url":"https://www.federalregister.gov/documents/2026/07/07/2026-13656/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-07/pdf/2026-13656.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13656.pdf?1782996328","publication_date":"2026-07-07","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"the Act, <span class=\"match\">requires</span> that hospitals that fail to report data <span class=\"match\">required</span> for the quality measures selected by the Secretary, in the form and manner <span class=\"match\">required</span> by the Secretary under section 1833(t)(17)(B) of the Act, incur a 2.0 percentage point reduction to their OPD fee schedule increase factor; that is, the annual payment update factor. The application of a reduced OPD fee schedule increase factor results in reduced national unadjusted payment rates that would apply to <span class=\"match\">certain</span> outpatient items and services furnished by hospitals that are <span class=\"match\">required</span> to report"},{"title":"Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to the Ketchikan Dock Company, LLC's Ketchikan Berth IV Expansion Project in the East Tongass Narrows, Alaska","type":"Notice","abstract":"NMFS has received a request from the Ketchikan Dock Company, LLC for authorization to take marine mammals incidental to construction work for the Ketchikan Berth IV Expansion Project in Ketchikan, Alaska in the East Tongass Narrows. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on a possible one-time, 1-year renewal that could be issued under certain circumstances and if all requirements are met, as described in Request for Public Comments at the end of this notice. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorization and agency responses will be summarized in the final notice of our decision.","document_number":"2025-18907","html_url":"https://www.federalregister.gov/documents/2025/09/30/2025-18907/takes-of-marine-mammals-incidental-to-specified-activities-taking-marine-mammals-incidental-to-the","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-30/pdf/2025-18907.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-18907.pdf?1759149911","publication_date":"2025-09-30","agencies":[{"raw_name":"DEPARTMENT OF COMMERCE","name":"Commerce Department","id":54,"url":"https://www.federalregister.gov/agencies/commerce-department","json_url":"https://www.federalregister.gov/api/v1/agencies/54","parent_id":null,"slug":"commerce-department"},{"raw_name":"National Oceanic and Atmospheric Administration","name":"National Oceanic and Atmospheric Administration","id":361,"url":"https://www.federalregister.gov/agencies/national-oceanic-and-atmospheric-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/361","parent_id":54,"slug":"national-oceanic-and-atmospheric-administration"}],"excerpts":"mal-protection-act \n without change. All personal identifying <span class=\"match\">information</span> (\n e.g., \n name, address) voluntarily submitted by the commenter may be publicly accessible. Do not submit confidential business <span class=\"match\">information</span> or otherwise sensitive or protected <span class=\"match\">information</span>.\n \n \n \n FOR FURTHER <span class=\"match\">INFORMATION</span> CONTACT: \n Kelsey Potlock, Office of Protected Resources, NMFS, (301) 427-8401. \n \n \n \n SUPPLEMENTARY <span class=\"match\">INFORMATION</span>: \n Background \n \n The MMPA prohibits the “take” of marine mammals, with <span class=\"match\">certain</span> exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S"},{"title":"Medicaid Program; Prohibition on Federal Medicaid and Children's Health Insurance Program Funding for Sex-Rejecting Procedures Furnished to Children","type":"Proposed Rule","abstract":"This proposed rule would require that a State Medicaid plan must provide that the Medicaid agency will not make payment under the plan for sex-rejecting procedures for children under 18 and prohibit the use of Federal Medicaid dollars to fund sex-rejecting procedures for individuals under the age of 18. In addition, it would require that a separate State Children's Health Insurance Program (CHIP) plan must provide that the CHIP agency will not make payment under the plan for sex-rejecting procedures for children under 19 and prohibit the use of Federal CHIP dollars to fund sex-rejecting procedures for individuals under the age of 19.","document_number":"2025-23464","html_url":"https://www.federalregister.gov/documents/2025/12/19/2025-23464/medicaid-program-prohibition-on-federal-medicaid-and-childrens-health-insurance-program-funding-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-19/pdf/2025-23464.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-23464.pdf?1766065528","publication_date":"2025-12-19","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"Collection of <span class=\"match\">Information</span> Requirements \n \n Under the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501-3520, we are <span class=\"match\">required</span> to provide notice in the \n Federal Register \n and solicit public comment before a “collection of <span class=\"match\">information</span>” requirement is submitted to the Office of Management and Budget (OMB) for review and approval. Collection of <span class=\"match\">information</span> is defined under 5 CFR 1320.3(c) of the PRA's implementing regulations.\n \n To fairly evaluate whether an <span class=\"match\">information</span> collection should be approved by OMB, 44 U.S.C. 3506(c)(2)(A) <span class=\"match\">requires</span> that we solicit"},{"title":"United States et al. v. Agri Stats, Inc.; Proposed Final Judgment and Competitive Impact Statement","type":"Notice","abstract":null,"document_number":"2026-11329","html_url":"https://www.federalregister.gov/documents/2026/06/05/2026-11329/united-states-et-al-v-agri-stats-inc-proposed-final-judgment-and-competitive-impact-statement","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-05/pdf/2026-11329.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11329.pdf?1780577117","publication_date":"2026-06-05","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Antitrust Division","name":"Antitrust Division","id":23,"url":"https://www.federalregister.gov/agencies/antitrust-division","json_url":"https://www.federalregister.gov/api/v1/agencies/23","parent_id":268,"slug":"antitrust-division"}],"excerpts":"“including” means including, but not limited to. \n K. “Individual <span class=\"match\">Information</span>” means the Non-Public <span class=\"match\">Information</span> of any single <span class=\"match\">Information</span> Contributor (regardless of whether such <span class=\"match\">information</span> or data is anonymized), including <span class=\"match\">information</span> or data at the Complex-, Business Unit-, or Meat Processor-level, which is not aggregated or otherwise combined with the <span class=\"match\">information</span> or data of another <span class=\"match\">Information</span> Contributor. \n L. “<span class=\"match\">Information</span> Contributor” means a Person that contributes its <span class=\"match\">information</span> or data to Agri Stats for use in Reporting by Agri Stats. \n \n M"},{"title":"Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Alaska LNG Project in Cook Inlet","type":"Proposed Rule","abstract":"NMFS has received a request from 8 Star Alaska, LLC (8 Star Alaska), a subsidiary of Alaska Gasline Development Corporation (AGDC), for authorization to take marine mammals incidental to the Alaska Liquefied Natural Gas (LNG) Project in Cook Inlet, Alaska, over the course of 5 years (2026-2030). Pursuant to the Marine Mammal Protection Act (MMPA), NMFS proposes regulations setting forth permissible methods of taking, other means of effecting the least practicable adverse impact on such marine mammal stocks (i.e., mitigation measures), and requirements pertaining to monitoring and reporting such takes, and requests comments on the proposed regulations. NMFS will consider public comments prior to making any final decision on the promulgation of the requested MMPA regulations, and NMFS' responses to public comments will be summarized in the final notification of our decision.","document_number":"2025-14342","html_url":"https://www.federalregister.gov/documents/2025/07/29/2025-14342/takes-of-marine-mammals-incidental-to-specified-activities-taking-marine-mammals-incidental-to","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-29/pdf/2025-14342.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-14342.pdf?1753706722","publication_date":"2025-07-29","agencies":[{"raw_name":"DEPARTMENT OF COMMERCE","name":"Commerce Department","id":54,"url":"https://www.federalregister.gov/agencies/commerce-department","json_url":"https://www.federalregister.gov/api/v1/agencies/54","parent_id":null,"slug":"commerce-department"},{"raw_name":"National Oceanic and Atmospheric Administration","name":"National Oceanic and Atmospheric Administration","id":361,"url":"https://www.federalregister.gov/agencies/national-oceanic-and-atmospheric-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/361","parent_id":54,"slug":"national-oceanic-and-atmospheric-administration"}],"excerpts":"summarize available <span class=\"match\">information</span> regarding status and trends, distribution and habitat preferences, and behavior and life history of the potentially affected species. NMFS fully considered all of this <span class=\"match\">information</span>, and we refer the reader to these descriptions instead of reprinting the <span class=\"match\">information</span>. Additional <span class=\"match\">information</span> regarding population trends and threats may be found in NMFS' Stock Assessment Reports (SARs; \n https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments \n ) and more general <span class=\"match\">information</span> about these"},{"title":"Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to the City of Hoonah's Cargo Dock Project, Hoonah, Alaska","type":"Notice","abstract":"NMFS has received a request from the City of Hoonah (Hoonah) for authorization to take marine mammals incidental to pile driving and removal activities associated with the Hoonah Cargo Dock project in Hoonah, Alaska. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on a possible one-time, 1-year renewal that could be issued under certain circumstances and if all requirements are met. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorization and agency responses will be summarized in the final notice of our decision.","document_number":"2025-00014","html_url":"https://www.federalregister.gov/documents/2025/01/07/2025-00014/takes-of-marine-mammals-incidental-to-specified-activities-taking-marine-mammals-incidental-to-the","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2025-00014.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-00014.pdf?1736171127","publication_date":"2025-01-07","agencies":[{"raw_name":"DEPARTMENT OF COMMERCE","name":"Commerce Department","id":54,"url":"https://www.federalregister.gov/agencies/commerce-department","json_url":"https://www.federalregister.gov/api/v1/agencies/54","parent_id":null,"slug":"commerce-department"},{"raw_name":"National Oceanic and Atmospheric Administration","name":"National Oceanic and Atmospheric Administration","id":361,"url":"https://www.federalregister.gov/agencies/national-oceanic-and-atmospheric-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/361","parent_id":54,"slug":"national-oceanic-and-atmospheric-administration"}],"excerpts":"l-protection-act \n without change. All personal identifying <span class=\"match\">information</span> (\n e.g., \n name, address) voluntarily submitted by the commenter may be publicly accessible. Do not submit confidential business <span class=\"match\">information</span> or otherwise sensitive or protected <span class=\"match\">information</span>.\n \n \n \n FOR FURTHER <span class=\"match\">INFORMATION</span> CONTACT: \n Rachel Wachtendonk, Office of Protected Resources, NMFS, (301) 427-8401. \n \n \n \n SUPPLEMENTARY <span class=\"match\">INFORMATION</span>: \n Background \n \n The MMPA prohibits the “take” of marine mammals, with <span class=\"match\">certain</span> exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U"},{"title":"Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to the City of Hoonah's Cargo Dock Project, Hoonah, Alaska","type":"Notice","abstract":"In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued an incidental harassment authorization (IHA) to the City of Hoonah (Hoonah) to incidentally harass marine mammals during pile driving and removal activities associated with the Hoonah Cargo Dock project in Hoonah, Alaska. There are no changes from the proposed authorization in this final authorization.","document_number":"2025-04071","html_url":"https://www.federalregister.gov/documents/2025/03/14/2025-04071/takes-of-marine-mammals-incidental-to-specified-activities-taking-marine-mammals-incidental-to-the","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-03-14/pdf/2025-04071.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-04071.pdf?1741869910","publication_date":"2025-03-14","agencies":[{"raw_name":"DEPARTMENT OF COMMERCE","name":"Commerce Department","id":54,"url":"https://www.federalregister.gov/agencies/commerce-department","json_url":"https://www.federalregister.gov/api/v1/agencies/54","parent_id":null,"slug":"commerce-department"},{"raw_name":"National Oceanic and Atmospheric Administration","name":"National Oceanic and Atmospheric Administration","id":361,"url":"https://www.federalregister.gov/agencies/national-oceanic-and-atmospheric-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/361","parent_id":54,"slug":"national-oceanic-and-atmospheric-administration"}],"excerpts":"submit relevant <span class=\"match\">information</span>, suggestions, and comments. During the 30-day public comment period, NMFS did not receive any public comments.\n \n Description of Marine Mammals in the Area of Specified Activities \n \n Sections 3 and 4 of the application summarize available <span class=\"match\">information</span> regarding status and trends, distribution and habitat preferences, and behavior and life history of the potentially affected species. NMFS fully considered all of this <span class=\"match\">information</span>, and we refer the reader to these descriptions, instead of reprinting the <span class=\"match\">information</span>. Additional"},{"title":"Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2026 Rates; Changes to the FY 2025 IPPS Rates Due to Court Decision; Requirements for Quality Programs; and Other Policy Changes; Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization","type":"Rule","abstract":"This final rule revises the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; makes changes relating to Medicare graduate medical education (GME) for teaching hospitals; updates the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); updates and makes changes to requirements for certain quality programs; and makes other policy- related changes. We are also finalizing the provisions of the interim final action with comment period regarding the changes to the FY 2025 IPPS rates due to the court decision in Bridgeport Hosp. v. Becerra. Lastly, it finalizes certain updates to the ONC Health Information Technology (IT) Certification Program.","document_number":"2025-14681","html_url":"https://www.federalregister.gov/documents/2025/08/04/2025-14681/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-ipps-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-04/pdf/2025-14681.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-14681.pdf?1753992911","publication_date":"2025-08-04","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"including the completed application forms, <span class=\"match\">certain</span> related materials, and any additional updated application <span class=\"match\">information</span> submitted subsequent to the initial application submission (except <span class=\"match\">certain</span> volume, cost and other <span class=\"match\">information</span> identified by the applicant as confidential), beginning with the application cycle for FY 2024, at the time the proposed rule is published. We also finalized that with the exception of <span class=\"match\">information</span> included in a confidential <span class=\"match\">information</span> section of the application, cost and volume <span class=\"match\">information</span>, and materials identified by the applicant"},{"title":"Clarifying the Eligibility of Deferred Action for Childhood Arrivals (DACA) Recipients and Certain Other Noncitizens for a Qualified Health Plan through an Exchange, Advance Payments of the Premium Tax Credit, Cost-Sharing Reductions, and a Basic Health Program","type":"Rule","abstract":"This final rule makes several clarifications and updates the definitions currently used to determine whether a consumer is eligible to enroll in a Qualified Health Plan (QHP) through an Exchange; a Basic Health Program (BHP), in States that elect to operate a BHP; and for Medicaid and Children's Health Insurance Programs (CHIPs). Specifically, Deferred Action for Childhood Arrivals (DACA) recipients and certain other noncitizens will be included in the definitions of \"lawfully present\" that are used to determine eligibility to enroll in a QHP through an Exchange, for Advance Payments of the Premium Tax Credit (APTC) and Cost-Sharing Reductions (CSRs), or for a BHP.","document_number":"2024-09661","html_url":"https://www.federalregister.gov/documents/2024/05/08/2024-09661/clarifying-the-eligibility-of-deferred-action-for-childhood-arrivals-daca-recipients-and-certain","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-08/pdf/2024-09661.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-09661.pdf?1714740321","publication_date":"2024-05-08","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"programs are <span class=\"match\">required</span> to have a plan in place and, in accordance with such plan, provide <span class=\"match\">certain</span> services to eligible juveniles within 30 days of their scheduled date of release from a public institution following adjudication, and CHIP programs are <span class=\"match\">required</span> to suspend, rather than terminate, CHIP coverage.\n \n \n \n \n 20 \n  Division G, Title I, Subtitle B of the Consolidated Appropriations Act (CAA), 2024 <span class=\"match\">requires</span> that State Medicaid agencies provide <span class=\"match\">certain</span> services for beneficiaries; that Medicaid and CHIP agencies engage in <span class=\"match\">certain</span> data collection"},{"title":"Mammography Quality Standards Act","type":"Rule","abstract":"The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). We are issuing updates to modernize the regulations by incorporating current science and mammography best practices. These updates are intended to improve the delivery of mammography services by strengthening the communication of healthcare information; allowing for more informed decision making by patients and providers (by requiring facilities to provide them with additional health information); helping to ensure the availability of qualified mammography personnel; bolstering the medical outcomes audit to provide feedback to improve mammography interpretations; modernizing technological aspects of the standards; and adding additional tools to deal with noncompliant facilities.","document_number":"2023-04550","html_url":"https://www.federalregister.gov/documents/2023/03/10/2023-04550/mammography-quality-standards-act","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-03-10/pdf/2023-04550.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-04550.pdf?1678369517","publication_date":"2023-03-10","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"following <span class=\"match\">breast</span> <span class=\"match\">density</span> notification statements. The non-dense <span class=\"match\">breast</span> notification (see § 900.12(c)(2)(iii) in this final rule) now states, “<span class=\"match\">Breast</span> tissue can be either dense or not dense. Dense tissue makes it harder to find <span class=\"match\">breast</span> cancer on a mammogram and also raises the risk of developing <span class=\"match\">breast</span> cancer. Your <span class=\"match\">breast</span> tissue is not dense. Talk to your healthcare provider about <span class=\"match\">breast</span> <span class=\"match\">density</span>, risks for <span class=\"match\">breast</span> cancer, and your individual situation.” The dense <span class=\"match\">breast</span> notification (see § 900.12(c)(2)(iv) in this final rule) now states, “<span class=\"match\">Breast</span> tissue"},{"title":"Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to the Sunrise Wind Offshore Wind Farm Project Offshore New York","type":"Rule","abstract":"In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA), as amended, NMFS hereby promulgates regulations to govern the incidental taking of marine mammals incidental to Sunrise Wind, LLC (Sunrise Wind), a 50/50 joint venture between [Oslash]rsted North America, Inc. ([Oslash]rsted) and Eversource Investment, LLC, construction of the Sunrise Wind Offshore Wind Farm Project (hereafter known as the \"Project\") in Federal and State waters offshore New York, specifically within the Bureau of Ocean Energy Management (BOEM) Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf (OCS) Lease Area OCS-A-0487 (Lease Area) and along one export cable route to sea- to-shore transition points in Shirley, New York (collectively referred to as the \"Project Area\"), over the course of 5 years (June 21, 2024--June 20, 2029). These regulations, which allow for the issuance of a Letter of Authorization (LOA) for the incidental take of marine mammals during construction-related activities within the Project Area during the effective dates of the regulations, prescribe the permissible methods of taking and other means of effecting the least practicable adverse impact on marine mammal species or stocks and their habitat as well as requirements pertaining to the monitoring and reporting of such taking.","document_number":"2024-09902","html_url":"https://www.federalregister.gov/documents/2024/05/22/2024-09902/takes-of-marine-mammals-incidental-to-specified-activities-taking-marine-mammals-incidental-to-the","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-22/pdf/2024-09902.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-09902.pdf?1716295513","publication_date":"2024-05-22","agencies":[{"raw_name":"DEPARTMENT OF COMMERCE","name":"Commerce Department","id":54,"url":"https://www.federalregister.gov/agencies/commerce-department","json_url":"https://www.federalregister.gov/api/v1/agencies/54","parent_id":null,"slug":"commerce-department"},{"raw_name":"National Oceanic and Atmospheric Administration","name":"National Oceanic and Atmospheric Administration","id":361,"url":"https://www.federalregister.gov/agencies/national-oceanic-and-atmospheric-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/361","parent_id":54,"slug":"national-oceanic-and-atmospheric-administration"}],"excerpts":"speed restriction, <span class=\"match\">requiring</span> Class A AIS, <span class=\"match\">requiring</span> PSOs on all vessels when underway as opposed to a “visual observer” and <span class=\"match\">requiring</span> service vessels to complement observer coverage with additional monitoring technologies (\n e.g., \n infrared (IR) detection devices for whales and other protected species, <span class=\"match\">requiring</span> Sunrise Wind to provide a vessel traffic plan, keeping 500 m away from NARW at all times and 100 m for other large whale species, <span class=\"match\">requiring</span> that all vessel personnel are trained in observing and identifying NARW, and <span class=\"match\">requiring</span> each vessel to"},{"title":"Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, Including the Hospital Inpatient Quality Reporting Program; Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals; Prior Authorization; Requests for Information; Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls Exceptions; Individuals Currently or Formerly in Custody of Penal Authorities; Revision to Medicare Special Enrollment Period for Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On Payment for High-Cost Drugs Provided by Indian Health Service and Tribal Facilities","type":"Rule","abstract":"This final rule with comment period revises the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2025 based on our continuing experience with these systems. We describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this final rule updates the requirements for the Hospital Outpatient Quality Reporting Program, Rural Emergency Hospital Quality Reporting Program, Ambulatory Surgical Center Quality Reporting Program, and Hospital Inpatient Quality Reporting Program. We also summarize information received in response to a Request for Information on potential modifications to the Safety of Care measure group in the Overall Hospital Quality Star Rating methodology. In this final rule, we are also finalizing our proposal to narrow the description of \"custody\" in the Medicare payment exclusion rule and to revise the special enrollment period criteria for formerly incarcerated individuals. We are also finalizing our Medicaid and Children's Health Insurance Program (CHIP) continuous eligibility provisions. We are also finalizing the proposal to reduce the review timeframe for standard prior authorization requests for certain covered outpatient department services paid under the OPPS from 10-business days to 7-calendar days. Further, this rule finalizes updates to the Conditions of Participation (CoPs) for hospitals and critical access hospitals (CAHs) in an effort to advance the health and safety of pregnant, birthing, and postpartum women. This rule also finalizes our proposed policy to separately pay Indian Health Service (IHS) and Tribal hospitals for high-cost drugs furnished in hospital outpatient departments through an add-on payment in addition to the all-inclusive rate (AIR) under the authorities used to calculate the AIR starting January 1, 2025. Finally, we are finalizing exceptions to the Medicaid clinic services four walls requirement for IHS and Tribal clinics, and, at state option, for behavioral health clinics and clinics located in rural areas.","document_number":"2024-25521","html_url":"https://www.federalregister.gov/documents/2024/11/27/2024-25521/medicare-and-medicaid-programs-hospital-outpatient-prospective-payment-and-ambulatory-surgical","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-11-27/pdf/2024-25521.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-25521.pdf?1730492130","publication_date":"2024-11-27","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"the Act, <span class=\"match\">requires</span> that hospitals that fail to report data <span class=\"match\">required</span> for the quality measures selected by the Secretary, in the form and manner <span class=\"match\">required</span> by the Secretary under section 1833(t)(17)(B) of the Act, incur a 2.0 percentage point reduction to their OPD fee schedule increase factor; that is, the annual payment update factor. The application of a reduced OPD fee schedule increase factor results in reduced national unadjusted payment rates that would apply to <span class=\"match\">certain</span> outpatient items and services furnished by hospitals that are <span class=\"match\">required</span> to report"},{"title":"Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances","type":"Rule","abstract":"Pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act (\"CERCLA\" or \"Superfund\"), the Environmental Protection Agency (EPA) is designating two per- and polyfluoroalkyl substances (PFAS)--perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers--as hazardous substances. The Agency reached this decision after evaluating the available scientific and technical information about PFOA and PFOS and determining that they may present a substantial danger to the public health or welfare or the environment when released. The Agency also determined that designation is warranted based on a totality of the circumstances analysis, including an analysis of the advantages and disadvantages of designation.","document_number":"2024-08547","html_url":"https://www.federalregister.gov/documents/2024/05/08/2024-08547/designation-of-perfluorooctanoic-acid-pfoa-and-perfluorooctanesulfonic-acid-pfos-as-cercla-hazardous","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-08/pdf/2024-08547.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-08547.pdf?1715085969","publication_date":"2024-05-08","agencies":[{"raw_name":"ENVIRONMENTAL PROTECTION AGENCY","name":"Environmental Protection Agency","id":145,"url":"https://www.federalregister.gov/agencies/environmental-protection-agency","json_url":"https://www.federalregister.gov/api/v1/agencies/145","parent_id":null,"slug":"environmental-protection-agency"}],"excerpts":"https://www.regulations.gov/. \n Although listed, some <span class=\"match\">information</span> is not publicly available, \n e.g., \n Confidential Business <span class=\"match\">Information</span> (CBI) or other <span class=\"match\">information</span> whose disclosure is restricted by statute. <span class=\"match\">Certain</span> other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy. With the exception of such material, publicly available docket materials are available electronically in \n https://www.regulations.gov. \n \n \n \n FOR FURTHER <span class=\"match\">INFORMATION</span> CONTACT: \n \n Sicy Jacob, Office of Emergency Management"},{"title":"Child Nutrition Programs: Meal Patterns Consistent With the 2020-2025 Dietary Guidelines for Americans","type":"Rule","abstract":"This rulemaking finalizes long-term school nutrition requirements based on the goals of the Dietary Guidelines for Americans, 2020-2025, robust stakeholder input, and lessons learned from prior rulemakings. Notably, this rulemaking gradually phases in added sugars limits for the school lunch and breakfast programs and in the Child and Adult Care Food Program, updates total sugars limits for breakfast cereals and yogurt to added sugars limits. As a reflection of feedback from stakeholders, this final rule implements a single sodium reduction in the school lunch and breakfast programs and commits to studying the potential associations between sodium reduction and student participation in the school lunch and breakfast programs. This rulemaking addresses a variety of other school meal requirements, including establishing long-term milk and whole grain requirements. Finally, this rule includes provisions that strengthen Buy American requirements. While this rulemaking takes effect school year 2024-2025, the Department is gradually phasing in required changes over time. Program operators are not required to make any changes to their menus as a result of this rulemaking until school year 2025-2026 at the earliest.","document_number":"2024-08098","html_url":"https://www.federalregister.gov/documents/2024/04/25/2024-08098/child-nutrition-programs-meal-patterns-consistent-with-the-2020-2025-dietary-guidelines-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-04-25/pdf/2024-08098.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-08098.pdf?1713962726","publication_date":"2024-04-25","agencies":[{"raw_name":"DEPARTMENT OF AGRICULTURE","name":"Agriculture Department","id":12,"url":"https://www.federalregister.gov/agencies/agriculture-department","json_url":"https://www.federalregister.gov/api/v1/agencies/12","parent_id":null,"slug":"agriculture-department"},{"raw_name":"Food and Nutrition Service","name":"Food and Nutrition Service","id":200,"url":"https://www.federalregister.gov/agencies/food-and-nutrition-service","json_url":"https://www.federalregister.gov/api/v1/agencies/200","parent_id":12,"slug":"food-and-nutrition-service"}],"excerpts":"public comments, respondents recommended that USDA <span class=\"match\">require</span> candidates to meet specific criteria, in addition to the candidate's years of experience, to qualify for this exception. In this final rule, USDA will not <span class=\"match\">require</span> candidates to meet specific criteria, beyond the <span class=\"match\">required</span> years of experience. However, school districts and State agencies may choose to <span class=\"match\">require</span> candidates to have specific types of experience in order to qualify under this exception. For example, a school district could <span class=\"match\">require</span> candidates to have experience managing a budget or"},{"title":"Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2026 Rates; Requirements for Quality Programs; and Other Policy Changes","type":"Proposed Rule","abstract":"This proposed rule would revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital- related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); update and make changes to requirements for certain quality programs; and make other policy-related changes.","document_number":"2025-06271","html_url":"https://www.federalregister.gov/documents/2025/04/30/2025-06271/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-the","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-04-30/pdf/2025-06271.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-06271.pdf?1744402510","publication_date":"2025-04-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"including the completed application forms, <span class=\"match\">certain</span> related materials, and any additional updated application <span class=\"match\">information</span> submitted subsequent to the initial application submission (except <span class=\"match\">certain</span> volume, cost and other <span class=\"match\">information</span> identified by the applicant as confidential), beginning with the application cycle for FY 2024, at the time the proposed rule is published. We also finalized that with the exception of <span class=\"match\">information</span> included in a confidential <span class=\"match\">information</span> section of the application, cost and volume <span class=\"match\">information</span>, and materials identified by the applicant"},{"title":"Regulatory Agenda","type":"Proposed Rule","abstract":"The Regulatory Flexibility Act of 1980 and Executive Order (E.O.) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.","document_number":"2023-14544","html_url":"https://www.federalregister.gov/documents/2023/07/27/2023-14544/regulatory-agenda","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-07-27/pdf/2023-14544.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-14544.pdf?1690375514","publication_date":"2023-07-27","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"blood and blood components, by capturing important new safety-related <span class=\"match\">information</span>, improving the quality and utility of submitted reports, and supporting enhanced alignment with internationally harmonized reporting guidelines. Among other things, the proposed rule would <span class=\"match\">require</span> the submission of <span class=\"match\">certain</span> nonclinical and clinical data to FDA in a periodic safety report, rather than the annual report. The proposed rule also would <span class=\"match\">require</span> application holders for drug products and <span class=\"match\">certain</span> biological products to establish and maintain a pharmacovigilance"},{"title":"Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to the Chevron Long Wharf Maintenance and Efficiency Program in San Francisco Bay, California","type":"Notice","abstract":"NMFS has received a request from Chevron Products Company for authorization to take marine mammals incidental to the Long Wharf Maintenance and Efficiency Program (LWMEP) in San Francisco Bay, California. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on a possible one-time, one-year renewal that could be issued under certain circumstances and if all requirements are met, as described in Request for Public Comments at the end of this notice. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorization and agency responses will be summarized in the final notice of our decision.","document_number":"2023-06744","html_url":"https://www.federalregister.gov/documents/2023/03/31/2023-06744/takes-of-marine-mammals-incidental-to-specified-activities-taking-marine-mammals-incidental-to-the","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-03-31/pdf/2023-06744.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-06744.pdf?1680180340","publication_date":"2023-03-31","agencies":[{"raw_name":"DEPARTMENT OF COMMERCE","name":"Commerce Department","id":54,"url":"https://www.federalregister.gov/agencies/commerce-department","json_url":"https://www.federalregister.gov/api/v1/agencies/54","parent_id":null,"slug":"commerce-department"},{"raw_name":"National Oceanic and Atmospheric Administration","name":"National Oceanic and Atmospheric Administration","id":361,"url":"https://www.federalregister.gov/agencies/national-oceanic-and-atmospheric-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/361","parent_id":54,"slug":"national-oceanic-and-atmospheric-administration"}],"excerpts":"used to drive 13 24-inch concrete piles at a rate of 2 piles per day (table 1).\n \n \n <span class=\"match\">Breasting</span> Dolphin and <span class=\"match\">Breasting</span> Point Construction \n —A new 24 ft (7.3 m) by 25 ft (7.6 m) <span class=\"match\">breasting</span> dolphin would be installed with a 13 ft (4 m) by 26 ft (7.9 m) <span class=\"match\">breasting</span> point with standoff fenders to accommodate barges. The <span class=\"match\">breasting</span> dolphin would be constructed using an impact hammer to install 17 24-inch concrete piles at a rate of 2 piles per day (table 1). The <span class=\"match\">breasting</span> point with standoff fenders would be installed using an impact hammer to drive 8 24-inch"}]}