Fabio
76b8ec33a7
Ingested titles 12–51 and 54 from OLRC USLM XML @119-100 (the whole Code now, uniform edition; Title 53 is reserved/empty). LegalText 11,221 -> 59,740; repo total 105,704 records. Deterministic (byte-identical rerun, verified on Title 42's 8,356 sections); make check green. make legal-us-code default now covers every title. Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>
36 lines
1.8 KiB
Markdown
36 lines
1.8 KiB
Markdown
---
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type: "LegalText"
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title: "21 U.S.C. § 360dd"
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description: "Open protocols for investigations of drugs for rare diseases or conditions"
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jurisdiction: "us"
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corpus: "united_states_code"
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kind: "code_section"
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title_number: 21
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title_name: "FOOD AND DRUGS"
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chapter_number: "9"
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chapter_name: "FEDERAL FOOD, DRUG, AND COSMETIC ACT"
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section: "360dd"
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citation: "21 U.S.C. § 360dd"
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status: "current"
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release_point: "119-100"
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release_date: "2026-06-26"
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source: "official"
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source_url: "https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc21@119-100.zip"
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source_identifier: "/us/usc/t21/s360dd"
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source_file: "data/legal/raw/us/code/title-21/usc21.xml"
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source_hash: "66d5be3e5fc6955b7ebcad11c520a0fee70e44d0275a3dc25050f45ac21ce2f9"
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raw_snapshot_hash: "3dbd7a61c8616baefb8459bd8dac3b93242106deb416308c8d4dd5a9143176d1"
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text_hash: "fcb9052590b854375078b20c886f894f51be8a7181ca35f6b8802798b0e02f71"
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retrieved_at: "2026-07-04"
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confidence: "official"
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tags: ["legal", "us-code"]
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---
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# 21 U.S.C. § 360dd - Open protocols for investigations of drugs for rare diseases or conditions
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## Text
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If a drug is designated under section 360bb of this title as a drug for a rare disease or condition and if notice of a claimed exemption under section 355(i) of this title or regulations issued thereunder is filed for such drug, the Secretary shall encourage the sponsor of such drug to design protocols for clinical investigations of the drug which may be conducted under the exemption to permit the addition to the investigations of persons with the disease or condition who need the drug to treat the disease or condition and who cannot be satisfactorily treated by available alternative drugs.
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(June 25, 1938, ch. 675, § 528, as added Pub. L. 97–414, § 2(a), Jan. 4, 1983, 96 Stat. 2051.)
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