E9-17680. New Drug Applications and Abbreviated New Drug Applications; Technical Amendment

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.

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 §§ 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

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

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.

§ 314.52

[Amended]

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”.

§ 314.53

[Amended]

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”.

§ 314.95

[Amended]

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.