CFR

Title 1 - General Provisions
Title 2 - Grants and Agreements
Title 3 - The President
Title 4 - Accounts
Title 5 - Administrative Personnel
Title 6 - Domestic Security
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Title 9 - Animals and Animal Products
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Title 13 - Business Credit and Assistance
Title 14 - Aeronautics and Space
Title 15 - Commerce and Foreign Trade
Title 16 - Commercial Practices
Title 17 - Commodity and Securities Exchanges
Title 18 - Conservation of Power and Water Resources
Title 19 - Customs Duties
Title 20 - Employees' Benefits
Title 21 - Food and Drugs
Title 22 - Foreign Relations
Title 23 - Highways
Title 24 - Housing and Urban Development
Title 25 - Indians
Title 26 - Internal Revenue
Title 27 - Alcohol, Tobacco Products and Firearms
Title 28 - Judicial Administration
Title 29 - Labor
Title 30 - Mineral Resources
Title 31 - Money and Finance: Treasury
Title 32 - National Defense
Title 33 - Navigation and Navigable Waters
Title 34 - Education
Title 35 - Panama Canal
Title 36 - Parks, Forests, and Public Property
Title 37 - Patents, Trademarks, and Copyrights
Title 38 - Pensions, Bonuses, and Veterans' Relief
Title 39 - Postal Service
Title 40 - Protection of Environment
Title 41 - Public Contracts and Property Management
Title 42 - Public Health
Title 43 - Public Lands: Interior
Title 44 - Emergency Management and Assistance
Title 45 - Public Welfare
Title 46 - Shipping
Title 47 - Telecommunication
Title 48 - Federal Acquisition Regulations System
Title 49 - Transportation
Title 50 - Wildlife and Fisheries

316.34—FDA recognition of exclusive approval.

(a) FDA will send the sponsor (or, the permanent-resident agent, if applicable) timely written notice recognizing exclusive approval once the marketing application for a designated orphan-drug product has been approved. The written notice will inform the sponsor of the requirements for maintaining orphan-drug exclusive approval for the full 7-year term of exclusive approval.

(b) When a marketing application is approved for a designated orphan drug that qualifies for exclusive approval, FDA will publish in its publication entitled “Approved Drug Products with Therapeutic Equivalence Evaluations” information identifying the sponsor, the drug, and the date of termination of the orphan-drug exclusive approval. A subscription to this publication and its monthly cumulative supplements is available from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325.

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