21 CFR 316.4

§ 316.4 Address for submissions.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 316.4, § 316.4 Address for submissions, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86417
Permanent ID: ys:prov:86417@1
SHA-256: 23c10589145b612e557eb434fc752e125cfd98c0fe03ca163b0941add83fd7f5

The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.

Full text

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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.