Department of Health and Human Services – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 64,528
Determination of Regulatory Review Period for Purposes of Patent Extension; Nuzyra Injection (New Drug Application 209817)
The Food and Drug Administration (FDA, the Agency, or we) has determined the regulatory review period for Nuzyra Injection (new drug application (NDA) 209817) 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; Rezurock
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Rezurock 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.
Privacy Act of 1974; Matching Program
In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of the re-establishment of a matching program between CMS and the Peace Corps for ``Verification of Eligibility for Minimum Essential Coverage Under the Patient Protection and Affordable Care Act through a Peace Corps Health Benefit Plan.''
Determination of Regulatory Review Period for Purposes of Patent Extension; Koselugo
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Koselugo 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.
Meetings of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a virtual meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The meeting will be open to the public and will be streamed live on hhs.gov/live. A pre-registered public comment session will be held during the meeting. Pre-registration is required for members of the public who wish to present their comments live during the virtual meeting. Individuals who wish to provide written public comment should send an email to CARB@hhs.gov that includes their written comments. Registration information is available on the website https:// www.hhs.gov/paccarb and should be completed by December 18, 2023 for the December 20, 2023 virtual Public Meeting. Additional information about registering for the meeting and providing public comment can be obtained at https://www.hhs.gov/paccarb on the Upcoming Meetings page. HHS is also giving notice of the appointment of 16 new PACCARB councilmembers that will be sworn-in in preparation of the December 20, 2023 virtual public meeting.
Proposed Information Collection Activity; Tribal Early Childhood Facilities Combined Application Guide (New Collection)
The Office of Early Childhood Development (ECD), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting Office of Management and Budget (OMB) approval of the Tribal Early Childhood Facilities Combined Application Guide for joint applications for construction and major renovation projects using both Head Start and Child Care and Development Fund (CCDF) resources.
Using Relative Supersaturation To Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry #284 entitled ``Using Relative Supersaturation to Support ``Urinary Tract Health'' Claims for Adult Maintenance Cat Food.'' FDA's Center for Veterinary Medicine (CVM) has evaluated the use of relative supersaturation (RSS) methodology to support urinary tract health claims for certain adult maintenance cat food. RSS is a measurement that estimates the potential for crystal formation and bladder stone growth, which is a common affliction in cats. This draft guidance provides recommendations for how pet food manufacturers can use RSS methodology to substantiate general structure or function claims that an adult maintenance cat food supports urinary tract health by promoting a healthy mineral content in the urinary tract.
Determination of Regulatory Review Period for Purposes of Patent Extension; Ukoniq
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Ukoniq 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; Qelbree
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Qelbree 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Temporary Marketing Permit Applications
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; Amondys 45
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Amondys 45 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.
Proposed Information Collection Activity; Survey of Staff Recruitment, Training, and Professional Development in Early Head Start (New Collection)
The Administration for Children & Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to conduct a nationally representative survey of Early Head Start (EHS) grant recipients regarding their recruitment, hiring, and professional development practices.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction and Combination Products
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; ZEGALOGUE
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZEGALOGUE 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.
Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Creams, or Ointment; and Liquid Wound Washes
The Food and Drug Administration (FDA, Agency, or we) are proposing to classify certain types of wound dressings and liquid wound washes containing antimicrobials and/or other chemicals (unclassified, preamendments devices) as solid wound dressings; wound dressings formulated as a gel, cream, or ointment; and liquid wound washes. FDA currently regulates these unclassified devices as devices requiring premarket notification (510(k) requirements), with the product codes FRO, GER, MGP, MGQ, and EFQ, but FDA intends to create new product codes for these proposed classifications upon finalization of this classification action. FDA is proposing to classify certain wound dressings and liquid wound washes containing antimicrobials with a high level of antimicrobial resistance (AMR) concern (i.e., medically important antimicrobials) into class III. In addition, FDA is proposing to classify certain wound dressings and liquid wound washes containing antimicrobials with a medium or low level of AMR concern and/or other chemicals, into class II (subject to special controls and 510(k) requirements).
Effective Date of Requirement for Premarket Approval Applications for Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Cream, or Ointment; and Liquid Wound Washes Containing Medically Important Antimicrobials
The Food and Drug Administration (FDA, Agency, or we) is proposing to require the filing of a premarket approval application (PMA) for certain solid wound dressings; wound dressings formulated as a gel, cream, or ointment; and liquid wound washes containing antimicrobials with a high level of antimicrobial resistance (AMR) concern (i.e., medically important antimicrobials) acting as either protectants or preservatives, which are unclassified, preamendments devices. FDA is summarizing its proposed findings regarding the degree or risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the PMA requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the benefits to the public from the use of the devices.
Determination of Regulatory Review Period for Purposes of Patent Extension; PYLARIFY
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for PYLARIFY 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 patents which claim that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; ORGOVYX
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Orgovyx 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 patents which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; Tukysa
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Tukysa 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; Empaveli
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Empaveli 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; Olinvyk
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Olinvyk 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; Kerendia
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Kerendia 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption
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 to OMB for Review and Approval; Public Comment Request; Rural Health Network Development Program Performance Improvement Measurement System, OMB No. 0906-0010-Revision
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Evidence Based Telehealth Network Program Measures
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Determination of Regulatory Review Period for Purposes of Patent Extension; Lupkynis
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Lupkynis 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; Azstarys
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Azstarys 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.
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; Shortages Data Collections
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 information collections associated with Shortages Data Collections and with notifications to FDA of an interruption or permanent discontinuance in manufacturing of certain medical devices as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Determination of Regulatory Review Period for Purposes of Patent Extension; Korsuva
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Korsuva 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.
Reporting of Pregnancy Success Rates From Assisted Reproductive Technology (ART) Programs; Proposed Modifications to Data Collection Fields and Data Validation Procedures; Request for Comment
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain comment on and review of proposed modifications to data collection fields for reporting of pregnancy success rates from assisted reproductive technology (ART) programs and proposed modifications to data validation procedures. This reporting is required by the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA).
Determination of Regulatory Review Period for Purposes of Patent Extension; Tavneos
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Tavneos 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 patents which claim that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; Cosela
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Cosela 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; Zeposia
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Zeposia 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.
Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt; Small Entity Compliance Guide; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to explain the actions a small entity must take to comply with FDA's regulations after recent changes made by our 2021 final rule titled ``Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt,'' 2022 final rule titled ``International Dairy Foods Association and Chobani, Inc.: Response to the Objections and Requests for a Public Hearing on the Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt,'' and 2023 final order titled ``International Dairy Foods Association: Response to the Objections and Requests for a Public Hearing on the Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and Amend the Standard for Yogurt.''
Medicare Program; Medicare Secondary Payer and Certain Civil Money Penalties; Correction
This document corrects technical errors in the final rule that appeared in the October 11, 2023 Federal Register titled ``Medicare Program; Medicare Secondary Payer and Certain Civil Money Penalties''.
World Trade Center Health Program Scientific/Technical Advisory Committee; Amended Notice of Solicitation of Nominations
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the World Trade Center (WTC) Health Program Scientific/Technical Advisory Committee (WTCHP-STAC), in accordance with provisions of the James Zadroga 9/11 Health and Compensation Act of 2010. The WTCHP-STAC consists of 17 members including experts in fields associated with occupational medicine, pulmonary medicine, environmental medicine, environmental health, industrial hygiene, epidemiology, toxicology, and mental health, and representatives of WTC responders as well as representatives of certified-eligible WTC survivors.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Requirements for Nonclinical Laboratory Studies
The Food and Drug Administration (FDA, we, or the Agency) 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; Qualitative Feedback on Agency Service Delivery
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.
Board of Scientific Counselors, National Center for Injury Prevention and Control; Notice of Charter Renewal
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the renewal of the charter of the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC).
Board of Scientific Counselors Infectious Diseases; (Formerly Known as the Board of Scientific Counselors, Deputy Director for Infectious Diseases); Notice of Charter Renewal
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the renewal of the charter of the Board of Scientific Counselors Infectious Diseases (BSC ID); (formerly known as the Board of Scientific Counselors, Deputy Director for Infectious Diseases (BSC, DDID)).
Request for Information: Temporary Assistance for Needy Families (TANF) Implementation of Sections 302 and 304 of the Fiscal Responsibility Act of 2023
The Administration for Children and Families (ACF), in the U.S. Department of Health and Human Services (HHS), invites public comments on the possibilities for design and implementation of the new pilot program and work outcomes measures of the Fiscal Responsibility Act of 2023 (FRA), in the Temporary Assistance for Needy Families (TANF) program. The FRA requires HHS to carry out a pilot program for up to five states to promote accountability by measuring employment and earnings outcomes as well as additional indicators of family stability and well-being for TANF recipients. In addition, it requires all states to report the information necessary to calculate certain statutory work outcomes measures. ACF seeks input from partners to help understand some of the options, opportunities, and potential challenges associated with the development and implementation of the pilot program and the reporting of new statutory work outcomes measures applicable to all states.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Blood Lead Surveillance System (BLSS). The National Center for Environmental Health (NCEH) is leading a three-year Extension for two CDC information collections, one for childhood blood lead surveillance by NCEH and another for adult blood lead surveillance by the National Institute for Occupational Safety and Health (NIOSH).
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
