Department of Health and Human Services June 17, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive
The Food and Drug Administration (FDA 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.
Medicare Program; Medicare Prescription Drug Benefit Program; Health Information Technology Standards and Implementation Specifications
This final rule will revise the Medicare Prescription Drug Benefit (Part D) and ONC regulations to implement changes related to required standards for electronic prescribing and adoption of health information technology (IT) standards for HHS use.
Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics," which provides recommendations for the development of oligonucleotide therapeutics. Specifically, this guidance addresses FDA's current thinking regarding clinical pharmacology considerations and recommendations for oligonucleotide therapeutic development programs, including characterizing the potential for QT interval prolongation, performing immunogenicity risk assessment, characterizing the impact of hepatic and renal impairment, and assessing the potential for drug-drug interactions. This guidance finalizes the draft guidance of the same name issued on June 27, 2022.
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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Operational Readiness Review 2.0. The Operational Readiness Review (ORR) is a rigorous, evidence-based assessment used to evaluate Public Health Emergency Preparedness (PHEP) recipient's planning and operational functions.
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 Public Health Laboratory Testing for Emerging Antimicrobial Resistance and Fungal Threats. This data collection is designed to allow CDC to test and characterize, antimicrobial resistant bacteria and fungal isolates.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1); Draft Guidance for Industry; Correction
The Food and Drug Administration (FDA or Agency) is correcting a notice that appeared in the Federal Register on May 23, 2024. The document announced the availability of a draft revised guidance for industry (GFI) #115 (VICH GL22) entitled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1)." The document erroneously included incorrect contact information. This document corrects that error.
Diabetic Foot Infections: Developing Drugs for Treatment; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Diabetic Foot Infections: Developing Drugs for Treatment." The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of diabetic foot infections (DFI) without concomitant bone and joint involvement. This guidance finalizes and replaces the draft guidance of the same title issued on October 17, 2023.
Requirements for Additional Traceability Records for Certain Foods; Proposed Exemption for Cottage Cheese Regulated by the National Conference on Interstate Milk Shipments Grade “A” Pasteurized Milk Ordinance
The Food and Drug Administration (FDA, the Agency, or we) is proposing to grant an exemption for certain cottage cheese products from the requirements of the Requirements for Additional Traceability Records for Certain Foods rule (the Food Traceability Rule). The Agency is taking this action in accordance with the FDA Food Safety Modernization Act and FDA's implementing regulations.
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