21 CFR § 316.4 - Address for submissions.

---
identifier: "/us/cfr/t21/s316.4"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 316.4 - Address for submissions."
title_number: 21
title_name: "Food and Drugs"
section_number: "316.4"
section_name: "Address for submissions."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "316"
part_name: "ORPHAN DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360aa, 360bb, 360cc, 360dd, 371."
regulatory_source: "57 FR 62085, Dec. 29, 1992, unless otherwise noted."
cfr_part: "316"
---


# 316.4 Address for submissions.

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]