Document ID: FDA-2013-N-0011-0003
Agency: fda
Document Type: Rule
Title: Biologics License Applications: Technical Amendment; Change of Address
Posted Date: 2013-04-02T04:00Z

[Federal Register Volume 78, Number 63 (Tuesday, April 2, 2013)]
[Rules and Regulations]
[Page 19585]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07578]

 ========================================================================
 Rules and Regulations
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains regulatory documents 
 having general applicability and legal effect, most of which are keyed 
 to and codified in the Code of Federal Regulations, which is published 
 under 50 titles pursuant to 44 U.S.C. 1510.
 
 The Code of Federal Regulations is sold by the Superintendent of Documents. 
 Prices of new books are listed in the first FEDERAL REGISTER issue of each 
 week.
 
 ========================================================================
 

  Federal Register / Vol. 78, No. 63 / Tuesday, April 2, 2013 / Rules 
and Regulations  

[[Page 19585]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 600

[Docket No. FDA-2013-N-0011]

Change of Address; Biologics License Applications; 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 update the address for applicants to submit biologics 
license applications (BLAs) and BLA amendments and supplements 
regulated by the Center for Drug Evaluation and Research (CDER). This 
action is being taken to ensure accuracy and clarity in the Agency's 
regulations.

DATES: This rule is effective April 2, 2013.

FOR FURTHER INFORMATION CONTACT: Scott E. Zeiss, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 1120, Silver Spring, MD 20993-0002, 301-
796-0639.

SUPPLEMENTARY INFORMATION: FDA is amending 21 CFR 600.2(b) to update 
the address for applicants to submit BLAs and BLA amendments and 
supplements regulated by CDER. The new address for all these 
submissions is CDER Central Document Room, Center for Drug Evaluation 
and Research, Food and Drug Administration, 5901B Ammendale Rd., 
Beltsville, MD 20705. This action is being taken to ensure accuracy and 
clarity in the Agency's regulations.
    Publication of this document constitutes final action on these 
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has 
determined that notice and public comment are unnecessary because this 
amendment to the regulations provides only technical changes to update 
an address for the submission of BLAs and BLA amendments and 
supplements.

List of Subjects for 21 CFR Part 600

    Biologics, 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 
600 is amended as follows:

PART 600--BIOLOGICAL PRODUCTS: GENERAL

0
1. The authority citation for 21 CFR part 600 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 360i, 371, 
374; 42 U.S.C. 216, 262, 263, 263a, 264, 300aa-25.

Sec.  600.2  [Amended]

0
2. Section 600.2 is amended in the first sentence of paragraph (b) by 
removing ``CDER Therapeutic Biological Products Document Room'' and 
adding in its place ``CDER Central Document Room'', and by removing 
``12229 Wilkins Ave., Rockville, MD 20852'' and adding in its place 
``5901B Ammendale Rd., Beltsville, MD 20705''.

    Dated: March 27, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07578 Filed 4-1-13; 8:45 am]
BILLING CODE 4160-01-P