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.

Code of Federal Regulations

[65 FR 56480, Sept. 19, 2000]

CFR

316.50—Guidance documents.

Code of Federal Regulations