21 CFR § 316.4 Orphan Drugs

§ 316.4 Address for submissions.

Current through Sep 8, 2026 · Read all of Part 316

All correspondence and requests for FDA action under the provisions of this rule should be addressed as follows: Office of Orphan Products Development, Food and Drug Administration, Bldg. 32, Rm. 5271, 10903 New Hampshire Ave., Silver Spring, MD 20993.

[78 FR 35133, June 12, 2013]

← § 316.3 Definitions.§ 316.10 Content and format of a request for written recommendations. →