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Electronic Code of Federal Regulations

e-CFR data is current as of April 2, 2020

Title 21 → Chapter I → Subchapter D → Part 316

TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER D—DRUGS FOR HUMAN USE

PART 316—ORPHAN DRUGS

rule

Subpart A—GENERAL PROVISIONS

§316.1
Scope of this part.
§316.2
Purpose.
§316.3
Definitions.
§316.4
Address for submissions.
rule

Subpart B—WRITTEN RECOMMENDATIONS FOR INVESTIGATIONS OF ORPHAN DRUGS

§316.10
Content and format of a request for written recommendations.
§316.12
Providing written recommendations.
§316.14
Refusal to provide written recommendations.
rule

Subpart C—DESIGNATION OF AN ORPHAN DRUG

§316.20
Content and format of a request for orphan-drug designation.
§316.21
Verification of orphan-drug status.
§316.22
Permanent-resident agent for foreign sponsor.
§316.23
Timing of requests for orphan-drug designation; designation of already approved drugs.
§316.24
Deficiency letters and granting orphan-drug designation.
§316.25
Refusal to grant orphan-drug designation.
§316.26
Amendment to orphan-drug designation.
§316.27
Change in ownership of orphan-drug designation.
§316.28
Publication of orphan-drug designations.
§316.29
Revocation of orphan-drug designation.
§316.30
Annual reports of holder of orphan-drug designation.
rule

Subpart D—ORPHAN-DRUG EXCLUSIVE APPROVAL

§316.31
Scope of orphan-drug exclusive approval.
§316.34
FDA recognition of exclusive approval.
§316.36
Insufficient quantities of orphan drugs.
rule

Subpart E—OPEN PROTOCOLS FOR INVESTIGATIONS

§316.40
Treatment use of a designated orphan drug.
rule

Subpart F—AVAILABILITY OF INFORMATION

§316.50
Guidance documents.
§316.52
Availability for public disclosure of data and information in requests and applications.

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