Legal Status
This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov.
The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.
The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts.
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- Public Inspection
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Topic
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Agency
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Office of Regulatory Affairs Division Director; Technical Amendments
The Food and Drug Administration (FDA, the Agency, or we) is revising chapter I of its regulations. These revisions are necessary to reflect changes to the Agency's organizational structure, including the reorganization of the Office of Regulatory Affairs. The revisions replace references to the District Director with references to the Division...
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Implementing the Food and Drug Administration Food Safety Modernization Act; Technical Amendment
The Food and Drug Administration (FDA, the Agency, or we) is correcting with technical amendments two final rules that published in the Federal Register of September 17, 2015, and one final rule that published in the Federal Register of November 27, 2015. The final rules published with editorial and inadvertent errors. This document corrects...
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Change of Address; Technical Amendment
The Food and Drug Administration (FDA or Agency) is amending its regulations to reflect a change of address for the Center for Drug Evaluation and Research's (CDER's) Office of Generic Drugs (OGD) Document Room from Rockville, MD, to Beltsville, MD. This action is being taken to ensure accuracy and clarity in the Agency's regulations.
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Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
The Food and Drug Administration (FDA or Agency) is proposing to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This proposed rule, if finalized, would allow an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject...
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Presiding Officer for an Appeal and Informal Hearing; Technical Amendments
The Food and Drug Administration (FDA, the Agency, or we) is making revisions to Chapter I of its regulations. These revisions are necessary to reflect changes to the Agency's organizational structure, including the dissolution of the Regional Food and Drug Director position. The revisions replace references to the Regional Food and Drug...
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Postmarketing Safety Reporting for Combination Products
The Food and Drug Administration (FDA or Agency) is issuing regulations to set forth postmarketing safety reporting requirements for combination products. Specifically, this final rule describes the postmarketing safety reporting requirements that apply when two or more different types of regulated medical products (drugs, devices, and/or...
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Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Technical Amendment
The Food and Drug Administration (FDA or we) is amending a final rule that published in the Federal Register of November 27, 2015. That final rule established science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. The rule sets forth...
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Administrative Actions for Noncompliance; Lesser Administrative Actions
The Food and Drug Administration (FDA) is amending the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA's IRB regulations. We are clarifying that FDA may require the IRB to withhold approval of new FDA-regulated studies, stop the enrollment of new...
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Administrative Actions for Noncompliance; Lesser Administrative Actions
The Food and Drug Administration (FDA) is proposing to amend the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA's IRB regulations. We are clarifying that FDA may require the IRB to withhold approval of new FDA-regulated studies, stop the enrollment...
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Investigational New Drug Applications for Biological Products; Bioequivalence Regulations; Technical Amendment
The Food and Drug Administration (FDA or Agency) is amending its regulations to update the address for applicants to submit investigational new drug applications (INDs) for biological products regulated by the Center for Drug Evaluation and Research (CDER). FDA is also amending its regulations on the criteria and evidence to assess actual and...
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Center for Food Safety and Applied Nutrition Library Address; Technical Amendments
The Food and Drug Administration (FDA or we) is amending certain regulations to update the location of references cited in our food regulations. We are taking this action to reflect the transfer of those references from our facility in College Park, MD, to our library at our main campus in Silver Spring, MD. We also are updating certain...
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Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA or we) is establishing science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA is...
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Food and Drug Administration Regulations; Change of Addresses; Technical Amendment
The Food and Drug Administration (FDA) is amending its regulations to update address information for the Center for Biologics Evaluation and Research (CBER) as a result of the recent relocation of CBER offices and laboratories to the FDA White Oak campus in Silver Spring, MD, as well as make other related technical revisions. These changes are...
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Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
The Food and Drug Administration (FDA or we) is proposing to amend certain specific provisions of the proposed rule, ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.'' We are taking this action because the extensive information received in public comments has led to significant changes in our...
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Institutional Review Boards; Correcting Amendments
The Food and Drug Administration (FDA) is amending its regulations regarding institutional review boards to address a minor correction to the regulatory text and to update contact information. This action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations.
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Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products
The Food and Drug Administration (FDA) is amending its regulations to provide additional safeguards for children enrolled in clinical investigations of FDA-regulated products. This rule finalizes the interim rule published in 2001 to bring FDA regulations into compliance with provisions of the Children's Health Act of 2000 (the Children's Health...
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Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA) is proposing to establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA is...
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Disqualification of a Clinical Investigator
The Food and Drug Administration (FDA) is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the...
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Medical Devices; Exception From General Requirements for Informed Consent
The Food and Drug Administration (FDA) is issuing a final regulation to confirm, with one change, the interim final rule (IFR) entitled ``Medical Devices; Exception From General Requirements for Informed Consent.'' This final rule confirms the IFR's establishment of a new exception from the general requirements for informed consent to permit the...
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Disqualification of a Clinical Investigator
The Food and Drug Administration (FDA) is proposing to amend the regulations to expand the scope of clinical investigator disqualification. Under this proposal, when the Commissioner of Food and Drugs determines that an investigator is ineligible to receive certain test articles (drugs, devices, or new animal drugs), the investigator also will...