[Code of Federal Regulations] [Title 21, Volume 5] [Revised as of April 1, 2008] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR316.4] [Page 176] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF PART 316_ORPHAN DRUGS--Table of Contents Subpart A_General Provisions Sec. 316.4 Address for submissions. 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.