Department of Health and Human Services June 7, 2024 – Federal Register Recent Federal Regulation Documents
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Proposal To Refuse To Approve a New Drug Application Supplement for HETLIOZ (Tasimelteon); Opportunity for a Hearing
The Director of the Center for Drug Evaluation and Research (Center Director) at the Food and Drug Administration (FDA or Agency) is proposing to refuse to approve a supplemental new drug application (sNDA) submitted by Vanda Pharmaceuticals, Inc. (Vanda), for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), in its present form. This notice summarizes the grounds for the Center Director's proposal and offers Vanda an opportunity to request a hearing on the matter.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Irradiation in the Production, Processing, and Handling of Food
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.
Food Additives Permitted in Feed and Drinking Water of Animals; Ethyl Cellulose
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of ethyl cellulose as a matrix scaffolding for tracers, and the ethyl cellulose shall not exceed 80 percent of the tracer. This action is in response to a food additive petition filed by Micro-Tracers, Inc.
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental Biologics License Application 761069/S-043 for IMFINZI (durvalumab) Injection
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.
Advisory Committee; Obstetrics, Reproductive and Urologic Drugs Advisory; Renewal
The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Obstetrics, Reproductive and Urologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Obstetrics, Reproductive and Urologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the March 23, 2026, expiration date.
Advisory Committee; Arthritis Advisory Committee; Renewal
The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Arthritis Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Arthritis Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the April 5, 2026, expiration date.
Medicare and Medicaid Programs: Application by the Community Health Accreditation Partner (CHAP) Inc. for Continued CMS-Approval of Its Hospice Accreditation Program
This notice acknowledges the receipt of an application from the Community Health Accreditation Partner for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs.
Privacy Act; Implementation
In accordance with subsections (j)(2) and (k)(2) of the Privacy Act of 1974, as amended (the Privacy Act or the Act), the Department of Health and Human Services (HHS or Department) is proposing to exempt a new system of records maintained by the National Institutes of Health (NIH), System No. 09-25-0224, "NIH Police Records," from certain requirements of the Act. The new system of records will cover criminal and non-criminal law enforcement investigatory material maintained by the NIH Division of Police, a component of NIH which performs criminal law enforcement as its principal function. The exemptions are necessary and appropriate to protect the integrity of law enforcement proceedings and records compiled in the course of NIH Division of Police activities, prevent disclosure of investigative techniques, and protect the identity of confidential sources involved in those activities. Elsewhere in the Federal Register, HHS/NIH has published a System of Records Notice (SORN) for System No. 09-25-0224 for public notice and comment which describes the new system of records in more detail.
Privacy Act of 1974; System of Records
In accordance with the requirements of the Privacy Act of 1974, as amended (Privacy Act, or Act), the Department of Health and Human Services (HHS) is establishing a new System of Records (SOR), 09- 25-0224, "NIH Police Records," to be maintained by the National Institutes of Health (NIH). The new system of records will contain records about individuals who are the subject of investigations of crime, civil disturbances, and traffic accidents occurring on or otherwise affecting the protection of life and property on NIH property. Because the records will constitute law enforcement investigatory material, elsewhere in the Federal Register the agency has published a notice of proposed rulemaking (NPRM) to exempt this system of records from certain requirements of the Privacy Act based on subsections (j)(2) and (k)(2) of the Act. The system of records is more fully described in the system of records notice (SORN) published in this notice.
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