Environmental Health Hazards Checklist Medicare Coverage for Individuals Exposed to Environmental Health Hazards (CMS-10902)

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 …

Determination of Regulatory Review Period for Purposes of Patent Extension; ORSERDU

The Food and Drug Administration FDA or the Agency has determined the regulatory review period for ORSERDU and is publishing this

The Food and Drug Administration’s Draft Strategy Document on Innovative Manufacturing Technologies

The Food and Drug Administration FDA or Agency is announcing the publication of a draft Strategy Document for public comment outlining specific actions FDA will take during fiscal years 2023-2027 …

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of Public Docket; Request for Comments—ProSense Cryoablation System

The Food and Drug Administration FDA announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee the Committee. The …

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic User Fee Payment Request Forms

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 …

Medicare and Medicaid Programs: Application from the Accreditation Commission for Health Care, Inc. for Continued Approval of its Home Health Agency Accreditation Program

This proposed notice acknowledges the receipt of an application from the Accreditation Commission for Health Care Inc. ACHC for continued recognition as a national accrediting organization for home health agencies …

Agency Information Collection Activities; Proposals, Submissions, and Approvals

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 …

Digital Health Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Total Product Lifecycle Considerations for Generative Artificial Intelligence-Enabled Medical Devices

The Food and Drug Administration FDA announces a forthcoming public advisory committee meeting of the Digital Health Advisory Committee the Committee. The general function of the Committee is to provide …

Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List; Revisions to the Withdrawn or Removed List

The Food and Drug Administration FDA announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee the Committee. The general function of the Committee is to provide …

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form 3601a

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 …

Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling Requirements for Prescription Drugs

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 …

Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments: Strain Selection for Influenza Vaccines

The Food and Drug Administration FDA announces a forthcoming public advisory committee meeting of the Vaccines and Related

Determination of Regulatory Review Period for Purposes of Patent Extension; ORSERDU

The Food and Drug Administration FDA or the Agency has determined the regulatory review period for ORSERDU and is publishing this

Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—New Drug Application 215244 for Elamipretide Hydrochloride Injection

The Food and Drug Administration FDA announces a forthcoming public advisory committee meeting of the Cardiovascular and Renal Drugs Advisory Committee the Committee. The general function of the Committee is …

Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community

The Food and Drug Administration FDA Agency or we is proposing to revoke the regulations entitled Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports Medical Device Quality System Audit Reports …

Agency Information Collection Activities; Proposals, Submissions, and Approvals

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 …

Biosimilar Product Development Guidance; Establishment of a Public Docket; Request for Information and Comments

The Food and Drug Administration FDA or Agency is announcing the establishment of a docket to obtain information and comments that will assist the Agency in assessing how best to …

Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public HealthInteroperability

This proposed rule seeks to advance interoperability improve transparency and support the access exchange and use of electronic health information through proposals for: standards adoption adoption of certification criteria to …

The PACE Organization Application Process in 42 CFR Part 460 (CMS-10631)

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 …

Determination of Regulatory Review Period for Purposes of Patent Extension; PLUVICTO

The Food and Drug Administration FDA or the Agency has determined the regulatory review period for PLUVICTO and is publishing this notice of that determination as required