Food and Drug Administration, HHS.
Final rule; technical amendment.
The Food and Drug Administration (FDA) is amending its new drug application (NDA) and abbreviated new drug application (ANDA) regulations to correct the address for the Orange Book Staff in the Office of Generic Drugs. This action is being taken to ensure accuracy and clarity in the agency's regulations.
This rule is effective July 24, 2009.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Olivia A. Pritzlaff, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 51, rm. 6308, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3506.End Further Info End Preamble Start Supplemental Information
FDA is amending its regulations in part 314 (21 CFR part 314) to correct the address for Orange Book Staff in the Office of Generic Drugs in §§ 314.52(a)(2), 314.53(f), and 314.95(a)(2).Start List of Subjects
List of Subjects in 21 CFR Part 314
- Administrative practice and procedure
- Confidential business information
- Reporting and recordkeeping requirements
Therefore, under the Federal Food, Drug, and Cosmetic Act and underEnd Amendment Part Start Part
PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUGEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. Section 314.52 is amended in paragraph (a)(2) by removing “at the address identified on FDA's Web site (End Amendment Part
3. Section 314.53 is amended in paragraph (f) by removing “at the address identified on FDA's Web site (End Amendment Part
4. Section 314.95 is amended in paragraph (a)(2) by removing “at the address identified on FDA's Web site (End Amendment Part Start Signature
Dated: July 17, 2009.
Associate Commissioner for Policy and Planning.
[FR Doc. E9-17680 Filed 7-23-09; 8:45 am]
BILLING CODE 4160-01-S