| http://www.w3.org/ns/prov#value | - condition for which the drug is intended affects fewer than 200,000 people in the United States or, if the drug is a vaccine, diagnostic drug, or preventive drug, the persons to whom the drug will be administered in the United States are fewer than 200,000 per year as specified in ??316.21(b), or (ii) For a drug intended for diseases or conditions affecting 200,000 or more people, or for a vaccin
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