21 CFR § 316.1 - Scope of this part.

---
identifier: "/us/cfr/t21/s316.1"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 316.1 - Scope of this part."
title_number: 21
title_name: "Food and Drugs"
section_number: "316.1"
section_name: "Scope of this part."
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"
---


# 316.1 Scope of this part.

(a) This part implements sections 525, 526, 527, and 528 of the act and provides procedures to encourage and facilitate the development of drugs for rare diseases or conditions, including biological products and antibiotics. This part sets forth the procedures and requirements for:

(1) Submissions to FDA of:

(i) Requests for recommendations for investigations of drugs for rare diseases or conditions;

(ii) Requests for designation of a drug for a rare disease or condition; and

(iii) Requests for gaining exclusive approval for a drug for a rare disease or condition.

(2) Allowing a sponsor to provide an investigational drug under a treatment protocol to patients who need the drug for treatment of a rare disease or condition.

(b) This part does not apply to food, medical devices, or drugs for veterinary use.

(c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

[57 FR 62085, Dec. 29, 1992, as amended at 78 FR 35132, June 12, 2013]