C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 316—ORPHAN DRUGS › Subpart A—General Provisions

21 C.F.R. § 316.1

Scope of this part

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(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]
Notes of Decisions
Cited in 3 cases, 2014–2015 · leading case: Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human Services
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Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human Services (2014) dcd “, 21 C.F.R. § 316.1 (a) ("This part implements sections 525, 526, 527, and 528 of the [Federal Food, Drug, and Cosmetic A]ct and provides procedures to encourage and facilitate the development of drugs for rare disease or conditions .”
Pharmaceutical Research & Manufacturers of America v. United States Department of Health & Human Services (2015) cadc “11 (citing 21 C.F.R. § 316.1 (a) (regulation promulgated by the FDA implementing the orphan-drug related sections of the Federal Food, Drug, and Cosmetic Act and providing “procedures to encourage and facilitate the development of drugs for rare diseases or conditions”)); see…”
Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human Services (2015) dcd “11 (citing 21 C.F.R. § 316.1 (a) (regulation promulgated by the FDA implementing the orphan-drug related sections of the Federal Food, Drug, and Cosmetic Act and providing “procedures to encourage and facilitate the development of drugs for rare diseases or conditions”)); see…”
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