Legal Status
Legal Status
Rule
New Drug Applications and Abbreviated New Drug Applications; Technical Amendment
A Rule by the Food and Drug Administration on
Document Details
Information about this document as published in the Federal Register.
- Printed version:
- Publication Date:
- 07/24/2009
- Agencies:
- Food and Drug Administration
- Dates:
- This rule is effective July 24, 2009.
- Effective Date:
- 07/24/2009
- Document Type:
- Rule
- Document Citation:
- 74 FR 36604
- Page:
- 36604-36605 (2 pages)
- CFR:
- 21 CFR 314
- Agency/Docket Number:
- Docket No. FDA-2009-N-0316
- Document Number:
- E9-17680
Document Details
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Published Document
This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule; technical amendment.
SUMMARY:
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.
DATES:
This rule is effective July 24, 2009.
Start Further InfoFOR 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 InformationSUPPLEMENTARY 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 SubjectsList of Subjects in 21 CFR Part 314
- Administrative practice and procedure
- Confidential business information
- Drugs
- Reporting and recordkeeping requirements
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
End Amendment Part Start PartPART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
End Part Start Amendment Part1. The authority citation for
End Amendment Part Start AuthorityAuthority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 356a, 356b, 356c, 371, 374, 379e.
End Authority2. Section 314.52 is amended in paragraph (a)(2) by removing “at the address identified on FDA's Web site (
End Amendment Part3. Section 314.53 is amended in paragraph (f) by removing “at the address identified on FDA's Web site (
End Amendment Part4. Section 314.95 is amended in paragraph (a)(2) by removing “at the address identified on FDA's Web site (
End Amendment Part Start SignatureDated: July 17, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-17680 Filed 7-23-09; 8:45 am]
BILLING CODE 4160-01-S