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21 C.F.R. § 316.50   Guidance documents.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 316—ORPHAN DRUGS
Subpart F—Availability of Information

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§ 316.50   Guidance documents.

FDA's Office of Orphan Products Development will maintain and make publicly available a list of guidance documents that apply to the regulations in this part. The list is maintained on the Internet and is published annually in the Federal Register. A request for a copy of the list should be directed to the Office of Orphan Products Development (HF–35), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.

[65 FR 56480, Sept. 19, 2000]

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