Document ID: FDA-2009-N-0316-0001
Agency: fda
Document Type: Rule
Title: New Drug Applications and Abbreviated New Drug Applications; Technical Amendment
Posted Date: 2009-07-24T04:00Z

[Federal Register: July 24, 2009 (Volume 74, Number 141)]
[Rules and Regulations]               
[Page 36604-36605]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jy09-2]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 314

[Docket No. FDA-2009-N-0316]

 
New Drug Applications and Abbreviated New Drug Applications; 
Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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.

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.

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 Sec. Sec.  314.52(a)(2), 314.53(f), and 
314.95(a)(2).

List of Subjects in 21 CFR Part 314

    Administrative practice and procedure, Confidential business 
information, Drugs, Reporting and recordkeeping requirements.

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

[[Page 36605]]

authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
314 is amended as follows:

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

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1. The authority citation for 21 CFR part 314 continues to read as 
follows:

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

Sec.  314.52  [Amended]

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2. Section 314.52 is amended in paragraph (a)(2) by removing ``at the 
address identified on FDA's Web site (http://www.fda.gov/cder/ogd)'' 
and by adding in its place ``7500 Standish Pl., Rockville, MD 20855''.

Sec.  314.53  [Amended]

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3. Section 314.53 is amended in paragraph (f) by removing ``at the 
address identified on FDA's Web site (http://www.fda.gov/cder/ogd)'' 
and by adding in its place ``7500 Standish Pl., Rockville, MD 20855''.

Sec.  314.95  [Amended]

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4. Section 314.95 is amended in paragraph (a)(2) by removing ``at the 
address identified on FDA's Web site (http://www.fda.gov/cder/ogd)'' 
and by adding in its place ``7500 Standish Pl., Rockville, MD 20855''.

    Dated: 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