Department of Health and Human Services – Federal Register Recent Federal Regulation Documents
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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: 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; JAYPIRCA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for JAYPIRCA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; SKYCLARYS
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SKYCLARYS 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.
Listing of Color Additives Exempt From Certification; Galdieria Extract Blue
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of galdieria extract blue, derived from unicellular red algae (Galdieria sulphuraria), in various food categories at levels consistent with good manufacturing practice (GMP). We are taking this action in response to a color additive petition (CAP) submitted by Fermentalg (Fermentalg or petitioner).
Listing of Color Additives Exempt From Certification; Calcium Phosphate
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of calcium phosphate as a color additive in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies. This action is in response to a color additive petition (CAP) filed by Innophos, Inc. (Innophos or petitioner).
Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of butterfly pea flower extract as a color additive in ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), and plain corn chips, tortilla chips, and multigrain chips at levels consistent with good manufacturing practice (GMP). This action is in response to a color additive petition (CAP) submitted by Sensient Colors, LLC (Sensient or petitioner).
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; LAMZEDE
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LAMZEDE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; SUNLENCA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SUNLENCA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; NGENLA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NGENLA 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 biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ELREXFIO 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 biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; LITFULO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LITFULO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Prescription Drug User Fee Act; Stakeholder Consultation Meetings on the Prescription Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholdersincluding patient and consumer advocacy groups, healthcare professionals, and scientific and academic expertsnotify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Prescription Drug User Fee Act (PDUFA). The statutory authority for PDUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting user fees for the prescription drug program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next PDUFA program. The FD&C Act also requires that FDA hold discussions (at least every month) with patient and consumer advocacy groups during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.
Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Final Report; Availability; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled "Product Quality Information Request Communications Assessment: Final Report." This report fulfills a commitment under the recent reauthorization of the Prescription Drug User Fee Act (PDUFA) to assess communication between FDA and applicants through product quality information requests during application review and to identify best practices and areas of improvement. The assessment of FDA and applicants in communicating through product quality information requests was conducted by an independent contractor, as described in the document entitled "PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027." As part of FDA performance commitments described in this document, FDA is publishing the final assessment report and soliciting public comments.
Determination That VOSOL (Acetic Acid, Glacial) 2% Otic Solution/Drops; and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Food Labeling: Front-of-Package Nutrition Information; Extension of Comment Period
The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule entitled "Food Labeling: Front- of-Package Nutrition Information" that appeared in the Federal Register of January 16, 2025. We are taking this action in response to requests for an extension to allow interested parties additional time to submit comments.
Medical Devices; Hematology and Pathology Devices; Classification of the Coagulation System for the Measurement of Whole Blood Viscoelastic Properties in Perioperative Patients
The Food and Drug Administration (FDA, Agency, or we) is classifying the coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Nucleic Acids by Fluorescence In Situ Hybridization in Clinical Specimens
The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect and identify microbial nucleic acids by fluorescence in situ hybridization (FISH) in clinical specimens into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial nucleic acids by FISH in clinical specimens classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect Nucleic Acids From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections and Associated Resistance Marker(s)
The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s) into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s)'s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Voriconazole Test System
The Food and Drug Administration (FDA, Agency, or we) is classifying the voriconazole test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the voriconazole test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Breast Milk Macronutrients Test System
The Food and Drug Administration (FDA, Agency, or we) is classifying the breast milk macronutrients test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the breast milk macronutrients test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Medical Devices; Immunology and Microbiology Devices; Classification of the Cytomegalovirus Nucleic Acid Detection Device for Congenital Cytomegalovirus Infection
The Food and Drug Administration (FDA, Agency, or we) is classifying the cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Medical Devices; Immunology and Microbiology Devices; Classification of the Microbial Nucleic Acid Storage and Stabilization Device
The Food and Drug Administration (FDA, Agency, or we) is classifying the microbial nucleic acid storage and stabilization device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the microbial nucleic acid storage and stabilization device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analytes To Aid in the Detection and Identification of Localized Human Infections
The Food and Drug Administration (FDA, the Agency, or we) is classifying the device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Government Owned Inventions Available for Licensing or Collaboration: Single Source-Detector Separation Approach To Calculate Tissue Oxygen Saturation
The National Institute of Child Health and Human Development (NICHD), an institute of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is giving notice of the licensing or collaboration opportunities for the inventions listed below, which are owned by an agency of the U.S. Government and are available for licensing and collaboration to achieve expeditious commercialization of results of federally-funded research and development.
Medical Devices; Immunology and Microbiology Devices; Classification of the DNA-Based Test To Measure Minimal Residual Disease in Hematological Malignancies
The Food and Drug Administration (FDA, Agency, or we) is classifying the DNA-based test to measure minimal residual disease in hematological malignancies into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the DNA-based test to measure minimal residual disease in hematological malignancies classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during January, February, and March 2025. The animal drug regulations are also being amended to improve their accuracy and readability.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting
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 revision 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 collections associated with requirements for medical device reporting for user facilities, manufacturers, importers, and distributors of medical devices.
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-2025-2026 Formula for COVID-19 Vaccines for Use in the United States
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The committee will meet in an open session to discuss and make recommendations on the selection of the 2025-2026 Formula for COVID-19 vaccines for use in the United States. FDA is establishing a docket for public comment on this document.
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental Biologics License Application 761309/S-001, for COLUMVI (glofitamab) Injection; Supplemental Biologics License Application 761145/S-029, for DARZALEX FASPRO (daratumumab and hyaluronidase) Injection; New Drug Application 215793, for (mitomycin) Intravesical Solution; Supplemental New Drug Application 211651/S-013, for TALZENNA (talazoparib) Capsules
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Medicare Program; Public Meeting for New Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding
This notice announces the first Healthcare Common Procedure Coding System (HCPCS) public meeting of 2025 to discuss the Centers for Medicare & Medicaid Services preliminary coding, Medicare benefit category, and Medicare payment determinations, if applicable, for new revisions to the HCPCS Level II code set for non-drug and non- biological items and services, as well as how to register for the meeting.
Submission for Office of Management and Budget Review; Current Population Survey-Child Support Supplement
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF) is requesting that the Office of Management and Budget (OMB) approve a revision to an approved information collection: Current Population SurveyChild Support Supplement. Information collected through the survey pertains to child support programs. Analysis of survey data helps OCSE fulfill the mandate to oversee the national child support program and will help legislators and policymakers determine the efficacy of various child support legislation. The current OMB approval expires August 31, 2025.
Proposed Information Collection Activity; Head Start Program Information Report
The Administration for Children and Families (ACF) Office of Head Start (OHS) is requesting a 3-year extension of the Head Start Program Information Report (PIR), Monthly Enrollment reporting instrument, and Center Locations and Contacts instrument (Office of Management and Budget (OMB) #0970-0427, expiration June 30, 2025). OHS has not made any updates to these instruments.
Proposed Information Collection Activity; Plan for Foster Care and Adoption Assistance-Title IV-E
The Administration for Children and Families (ACF) is requesting a 3-year extension and revisions to the Plan for Foster Care and Adoption AssistanceTitle IV-E, (OMB#: 0970-0433, expiration July 31, 2025). This plan also incorporates the plan requirements for the optional guardianship assistance, Title IV-E prevention services and the Title IV-E kinship navigator programs.
Proposed Information Collection Activity; National Directory of New Hires
The Office of Child Support Services (OCSS), Administration for Children and Families (ACF), is requesting the Office of Management and Budget (OMB) to approve the National Directory of New Hires (NDNH), with minor changes to the Multistate Employer Registration form, for an additional three years. The current OMB approval expires July 31, 2025.
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