Legal Status
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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.
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- Public Inspection
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Agency
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Investigational New Drug Applications; Amendment to Clinical Hold Regulations for Products Intended for Life-Threatening Diseases and Conditions
The Food and Drug Administration (FDA) is amending the regulations governing investigational new drug applications (IND's) to permit FDA to place a clinical hold on one or more studies under an IND involving a drug that is intended to treat a life-threatening disease or condition affecting both genders. The amendments permit the agency to place...
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Administrative Practices and Procedures; Good Guidance Practices
The Food and Drug Administration (FDA) is amending its administrative regulations to codify its policies and procedures for the development, issuance, and use of guidance documents. This action is necessary to comply with requirements of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The Modernization Act...
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Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Human Gene Therapy or Xenotransplantation
The Food and Drug Administration (FDA) is proposing to amend the biologics licensing regulations regarding confidentiality of information. The amendments would add provisions that would make available for public disclosure, and require submission for public disclosure of, certain data and information related to human gene therapy or...
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Marking Requirements for and Prohibitions on the Reimportation of Imported Food Products That Have Been Refused Admission into the United States
The Food and Drug Administration (FDA) is proposing to amend the food import regulations to require food products which, for safety reasons, are refused entry into the United States to be marked ``UNITED STATES REFUSED ENTRY.'' The proposed rule would also prohibit persons from refusing to affix this mark on refused food, from importing or...
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Safety Reporting Requirements for Human Drug and Biological Products
The Food and Drug Administration (FDA) is proposing to amend its pre- and postmarketing safety reporting regulations for human drug and biological products to implement definitions and reporting formats and standards recommended by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for...
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Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
The Food and Drug Administration (FDA) is issuing an interim final regulation that requires domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States to register with FDA by December 12, 2003. The interim final rule implements the Public Health Security and Bioterrorism...
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Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
The Food and Drug Administration (FDA) is issuing an interim final regulation that requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. The interim final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the...
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Administrative Detention of Food for Human or Animal Consumption Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
The Food and Drug Administration (FDA) is issuing a final regulation that provides procedures for the detention of an article of food, if an officer or qualified employee of FDA has credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals...
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Expanded Access to Investigational Drugs for Treatment Use
The Food and Drug Administration (FDA) is proposing to amend its regulations on access to investigational new drugs for the treatment of patients. The proposed rule would clarify existing regulations and add new types of expanded access for treatment use. Under the proposal, expanded access to investigational drugs for treatment use would be...
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Charging for Investigational Drugs
The Food and Drug Administration (FDA) is proposing to amend its investigational new drug application (IND) regulation concerning charging patients for investigational new drugs. FDA is proposing to revise the current charging regulation to clarify the circumstances in which charging for an investigational drug in a clinical trial is...
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Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
The Food and Drug Administration (FDA) is issuing regulations to permit FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or medical devices that are or will be included in the Strategic National Stockpile (SNS). Under this rule, the appropriate...
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Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
The Food and Drug Administration (FDA) is amending its regulations on acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) (non-IND foreign clinical studies) as support for an IND or application for marketing approval for a drug or biological product. The final rule replaces the requirement...
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Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications
The Food and Drug Administration (FDA) is amending its regulations on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for approval to market new drugs and generic drugs (drugs for which approval is sought in an ANDA). The final rule discontinues FDA's use of approvable letters and not approvable letters when taking...
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Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
The Food and Drug Administration (FDA) is issuing a final regulation that requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act),...
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Change of Addresses and Names; Technical Amendment
The Food and Drug Administration (FDA) is amending its regulations to reflect a change of address for the Center for Drug Evaluation and Research's (CDER's) Central Document Room in Beltsville, MD; the relocation of certain CDER offices to the White Oak campus in Silver Spring, MD; and changes of the names of certain CDER organizational units....
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Charging for Investigational Drugs Under an Investigational New Drug Application
The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulation concerning charging patients for investigational new drugs. This final rule revises the charging regulation to clarify the circumstances in which charging for an investigational drug in a clinical trial is appropriate, to set forth...
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Expanded Access to Investigational Drugs for Treatment Use
The Food and Drug Administration (FDA) is amending its regulations on access to investigational new drugs for the treatment of patients. The final rule clarifies existing regulations and adds new types of expanded access for treatment use. Under the final rule, expanded access to investigational drugs for treatment use is available to individual...
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Reporting Information Regarding Falsification of Data
The Food and Drug Administration (FDA) is proposing to amend its regulations to require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data in the course of reporting study results, or in the course of proposing, designing, performing, recording, supervising, or reviewing studies that...
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Medical Devices; Technical Amendment
The Food and Drug Administration (FDA) is amending certain medical device regulations to correct statutory and regulatory references to ensure accuracy, consistency, and clarity in the agency's regulations.
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Change of Contact Information; Technical Amendment
The Food and Drug Administration (FDA) is amending its regulations to reflect changes in the contact information for the FDA Emergency Call Center. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.