Chapter I – Food and Drug Administration
E586776
Chapter I – Food and Drug Administration is the portion of Title 21 of the Code of Federal Regulations that contains the primary federal rules governing the oversight of food, drugs, medical devices, and related products by the U.S. Food and Drug Administration.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Chapter I – Food and Drug Administration canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T6329933 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: Chapter I – Food and Drug Administration Context triple: [Title 21 of the Code of Federal Regulations, chapter, Chapter I – Food and Drug Administration]
-
A.
Chapter 15 – Federal Register and Code of Federal Regulations
Chapter 15 – Federal Register and Code of Federal Regulations is the portion of U.S. federal law that establishes the legal framework for publishing, organizing, and maintaining the Federal Register and the Code of Federal Regulations.
-
B.
Federal Food, Drug, and Cosmetic Act
The Federal Food, Drug, and Cosmetic Act is a key U.S. law that authorizes the Food and Drug Administration to regulate the safety, labeling, and marketing of food, drugs, medical devices, and cosmetics.
-
C.
Food and Drug Administration Modernization Act of 1997
The Food and Drug Administration Modernization Act of 1997 is a U.S. law that overhauled FDA regulatory procedures to speed the approval of drugs and medical devices while enhancing patient access to experimental therapies and modernizing agency operations.
-
D.
Food and Drug Administration
The Food and Drug Administration is a U.S. federal agency responsible for protecting public health by regulating food, drugs, medical devices, and other consumer products.
-
E.
FDA CFSAN
FDA CFSAN is the U.S. Food and Drug Administration’s center responsible for regulating the safety, labeling, and nutritional quality of foods, dietary supplements, and cosmetics.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: Chapter I – Food and Drug Administration Target entity description: Chapter I – Food and Drug Administration is the portion of Title 21 of the Code of Federal Regulations that contains the primary federal rules governing the oversight of food, drugs, medical devices, and related products by the U.S. Food and Drug Administration.
-
A.
Chapter 15 – Federal Register and Code of Federal Regulations
Chapter 15 – Federal Register and Code of Federal Regulations is the portion of U.S. federal law that establishes the legal framework for publishing, organizing, and maintaining the Federal Register and the Code of Federal Regulations.
-
B.
Federal Food, Drug, and Cosmetic Act
The Federal Food, Drug, and Cosmetic Act is a key U.S. law that authorizes the Food and Drug Administration to regulate the safety, labeling, and marketing of food, drugs, medical devices, and cosmetics.
-
C.
Food and Drug Administration Modernization Act of 1997
The Food and Drug Administration Modernization Act of 1997 is a U.S. law that overhauled FDA regulatory procedures to speed the approval of drugs and medical devices while enhancing patient access to experimental therapies and modernizing agency operations.
-
D.
Food and Drug Administration
The Food and Drug Administration is a U.S. federal agency responsible for protecting public health by regulating food, drugs, medical devices, and other consumer products.
-
E.
FDA CFSAN
FDA CFSAN is the U.S. Food and Drug Administration’s center responsible for regulating the safety, labeling, and nutritional quality of foods, dietary supplements, and cosmetics.
- F. None of above. chosen
Statements (42)
| Predicate | Object |
|---|---|
| instanceOf |
federal regulation
ⓘ
portion of Title 21 of the Code of Federal Regulations ⓘ |
| administeredBy | U.S. Food and Drug Administration NERFINISHED ⓘ |
| appliesTo |
biological products regulated by the U.S. Food and Drug Administration
ⓘ
cosmetics regulated by the U.S. Food and Drug Administration ⓘ food products regulated by the U.S. Food and Drug Administration ⓘ human drugs regulated by the U.S. Food and Drug Administration ⓘ medical devices regulated by the U.S. Food and Drug Administration ⓘ radiation-emitting electronic products regulated by the U.S. Food and Drug Administration ⓘ tobacco products regulated by the U.S. Food and Drug Administration ⓘ veterinary products regulated by the U.S. Food and Drug Administration ⓘ |
| codifiedIn | Code of Federal Regulations NERFINISHED ⓘ |
| country |
United States of America
ⓘ
surface form:
United States
|
| governs |
oversight of drugs by the U.S. Food and Drug Administration
ⓘ
oversight of food by the U.S. Food and Drug Administration ⓘ oversight of medical devices by the U.S. Food and Drug Administration ⓘ oversight of related products by the U.S. Food and Drug Administration ⓘ primary federal rules for FDA oversight of regulated products ⓘ |
| hasAbbreviation | 21 CFR Chapter I ⓘ |
| jurisdictionOf | U.S. Food and Drug Administration NERFINISHED ⓘ |
| language | English ⓘ |
| legalAuthorityFor | federal rules for FDA-regulated products ⓘ |
| legalBasisFor |
FDA enforcement actions regarding drugs
ⓘ
FDA enforcement actions regarding food ⓘ FDA enforcement actions regarding medical devices ⓘ FDA enforcement actions regarding related products ⓘ |
| partOf | Title 21 of the Code of Federal Regulations NERFINISHED ⓘ |
| regulates |
adulteration standards for FDA-regulated products
ⓘ
clinical investigation requirements for certain FDA-regulated products ⓘ good manufacturing practice requirements for FDA-regulated products ⓘ import and export of FDA-regulated products ⓘ labeling requirements for FDA-regulated products ⓘ misbranding standards for FDA-regulated products ⓘ post-market surveillance requirements for FDA-regulated products ⓘ pre-market approval processes for certain FDA-regulated products ⓘ registration and listing of establishments for FDA-regulated products ⓘ |
| subjectOf | federal regulatory compliance for FDA-regulated industries ⓘ |
| titleNumber | 21 ⓘ |
| usedBy |
FDA staff
ⓘ
compliance officers ⓘ regulated industry stakeholders ⓘ regulatory attorneys ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: Chapter I – Food and Drug Administration Description of subject: Chapter I – Food and Drug Administration is the portion of Title 21 of the Code of Federal Regulations that contains the primary federal rules governing the oversight of food, drugs, medical devices, and related products by the U.S. Food and Drug Administration.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.