04-6286. Change of Address; Technical Amendment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending its regulations to reflect a change in the address for the Center for Drug Evaluation and Research's (CDER) Central Document Room. This action is editorial in nature and is intended to provide accuracy and clarity to the agency's regulations.

EFFECTIVE DATE:

March 23, 2004

FOR FURTHER INFORMATION CONTACT:

Cathie L. Schumaker, Center for Drug Evaluation and Research (HFD-143), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7755.

SUPPLEMENTARY INFORMATION:

FDA is amending its regulations in parts 312 and 314 (21 CFR parts 312 and 314) to reflect a change in the address for CDER's Central Document Room. Under FDA regulations, applicants must submit to this location information related to marketing applications.

Publication of this document constitutes final action on these changes under the Administrative Procedure Act (5 U.S.C. 553). Notice and public procedure are unnecessary because FDA is merely correcting nonsubstantive errors.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 312 and 314 are amended as follows:

1. Section 312.140(a) is amended by removing “Park Bldg., Rm. 214, 12420 Parklawn Dr., Rockville, MD 20852” and by adding in its place “5901-B Ammendale Rd., Beltsville, MD 20705-1266.”

2. Section 314.53(d)(4) is amended by removing “Park Bldg., rm. 2-14, 12420 Parklawn Dr., Rockville, MD 20857” and by adding in its place “5901-B Ammendale Rd., Beltsville, MD 20705-1266.”

3. Section 314.80(c) introductory text is amended by removing “12229 Wilkins Ave., Rockville, MD 20852” and by adding in its place “5901-B Ammendale Rd., Beltsville, MD 20705-1266.”

4. Section 314.420(a)(5) is amended by removing “12229 Wilkins Ave., Rockville, MD 20852” and by adding in its place “5901-B Ammendale Rd., Beltsville, MD 20705-1266.”

5. Section 314.440(a)(1) is amended by removing “12420 Parklawn Dr., Rockville, MD 20852” and by adding in its place “5901-B Ammendale Rd., Beltsville, MD 20705-1266.”

Dated: March 15, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.