21 C.F.R. § 316.4 Address for submissions.
Title 21 - Food and Drugs
All correspondence and requests for FDA action pursuant to the provisions of this rule should be addressed as follows: Office of Orphan Products Development (HF–35), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
Title 21: Food and Drugs
PART 316—ORPHAN DRUGS
Subpart A—General Provisions
§ 316.4 Address for submissions.