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Rule

New Drug Applications and Abbreviated New Drug Applications; Technical Amendment

A Rule by the Food and Drug Administration on 07/24/2009

Document Details

Information about this document as published in the Federal Register.

Printed version:
PDF
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.

Start Preamble

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 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

SUPPLEMENTARY 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

End List of Subjects Start Amendment Part

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

End Amendment Part Start Part

PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

End Part Start Amendment Part

1. The authority citation for

End Amendment Part Start Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 356a, 356b, 356c, 371, 374, 379e.

End Authority
[Amended]
Start 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
[Amended]
Start 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
[Amended]
Start 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.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

End Signature End Supplemental Information

[FR Doc. E9-17680 Filed 7-23-09; 8:45 am]

BILLING CODE 4160-01-S

Published Document