Department of Health and Human Services August 16, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
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.
Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting; Draft Guidance for Industry; Availability; Reopening of the Comment Period
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of availability that published in the Federal Register of June 8, 2023. In that notice, FDA requested comments on the draft guidance for industry (GFI) #279 entitled ``Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to develop and submit comments.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, Change of Sponsor, Change of Sponsor Address
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 April, May, and June 2023. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve their accuracy and readability.
Food Standards of Identity Modernization; Pasteurized Orange Juice; Request for Information
The Food and Drug Administration (FDA or we) is announcing that the Florida Citrus Processors Association (FCPA) and Florida Citrus Mutual (FCM) have filed a citizen petition requesting that we amend the standard of identity (SOI) for pasteurized orange juice (POJ) by adjusting the minimum soluble solids content from 10.5[deg] to 10[deg] Brix. We are issuing this document to request comments, data, and information about the issues presented in the petition.
Health Resources Priorities and Allocations System (HRPAS)
The Department of Health and Human Services (HHS) is issuing a Notice of Proposed Rule Making (NPRM) to establish standards and procedures by which it may require acceptance and priority performance of certain contracts or orders to promote the national defense over other contracts or orders with respect to health resources. This proposed rule also sets new standards and procedures by which HHS may allocate materials, services, and facilities to promote the national defense.
Meeting of the National Advisory Committee on Rural Health and Human Services
In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's National Advisory Committee on Rural Health and Human Services (NACRHHS) scheduled a public meeting. Information about NACRHHS and the agenda for this meeting can be found on the NACRHHS website at https://www.hrsa.gov/advisory-committees/ rural-health/.
Announcement of the Advisory Panel on Outreach and Education (APOE) In-Person Meeting
This notice announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace[supreg], Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors.'' The guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA- regulated products in carrying out their responsibilities related to informed consent. The guidance provides the Agency's recommendations regarding informed consent and describes FDA regulatory requirements to help assure the protection of the rights and welfare of human subjects in clinical investigations. This guidance finalizes the draft guidance entitled, ``Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors,'' issued on July 15, 2014, and supersedes FDA's guidance entitled ``A Guide to Informed Consent,'' issued in September 1998.
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