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

12.38—Effective date of an order.

(a) If a person who is subject to a notice of opportunity for hearing under § 12.21(b) does not request a hearing, the Commissioner will—

(1) Publish a final order denying or withdrawing approval of an NDA, NADA, device premarket approval application, or biologics license, in whole or in part, or revoking a device product development protocol or notice of completion, or declaring that such a protocol has not been completed, and stating the effective date of the order; and

(2) If the order involves withdrawal of approval of an NADA, forthwith revoke, in whole or in part, the applicable regulation, under section 512(i) of the act.

(b) If a person who is subject to a notice of opportunity for hearing under § 12.21(b) requests a hearing and others do not, the Commissioner may issue a final order covering all the drug or device products at once or may issue more than one final order covering different drug or device products at different times.

Tips