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.
CFR 21-316.4-2013 history
2013CFR 21-316.4-2013 Food and drugs. Part316:Orphan drugs. Section316.4:Address for submissions.