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
- Title 7 - Agriculture
- Title 8 - Aliens and Nationality
- Title 9 - Animals and Animal Products
- Title 10 - Energy
- Title 11 - Federal Elections
- Title 12 - Banks and Banking
- 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
314.122—Submitting an abbreviated application for, or a 505(j)(2)(C) petition that relies on, a listed drug that is no longer marketed.
(a)
An abbreviated new drug application that refers to, or a petition under section 505(j)(2)(C) of the act and § 314.93 that relies on, a listed drug that has been voluntarily withdrawn from sale in the United States must be accompanied by a petition seeking a determination whether the listed drug was withdrawn for safety or effectiveness reasons. The petition must be submitted under §§ 10.25(a) and 10.30 of this chapter and must contain all evidence available to the petitioner concerning the reasons for the withdrawal from sale.
(b)
When a petition described in paragraph (a) of this section is submitted, the agency will consider the evidence in the petition and any other evidence before the agency, and determine whether the listed drug is withdrawn from sale for safety or effectiveness reasons, in accordance with the procedures in § 314.161.
(c)
An abbreviated new drug application described in paragraph (a) of this section will be disapproved, under § 314.127(a)(11), and a 505(j)(2)(C) petition described in paragraph (a) of this section will be disapproved, under § 314.93(e)(1)(iv), unless the agency determines that the withdrawal of the listed drug was not for safety or effectiveness reasons.
(d)
Certain drug products approved for safety and effectiveness that were no longer marketed on September 24, 1984, are not included in the list. Any person who wishes to obtain marketing approval for such a drug product under an abbreviated new drug application must petition FDA for a determination whether the drug product was withdrawn from the market for safety or effectiveness reasons and request that the list be amended to include the drug product. A person seeking such a determination shall use the petition procedures established in § 10.30 of this chapter. The petitioner shall include in the petition information to show that the drug product was approved for safety and effectiveness and all evidence available to the petitioner concerning the reason that marketing of the drug product ceased.
Code of Federal Regulations
Tips