Document ID: FDA-2011-N-0101-0001
Agency: fda
Document Type: Rule
Title: Requests for Exemption From the Bar Code Label Requirements; Change of Address
Posted Date: 2011-03-09T05:00Z

[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Rules and Regulations]
[Page 12847]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5288]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 201

[Docket No. FDA-2011-N-0101]

Change of Address; Requests for Exemption From the Bar Code Label 
Requirements

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 
regulations to update the address for submitting bar code exemption 
requests to 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 March 9, 2011.

FOR FURTHER INFORMATION CONTACT: Rikin Mehta, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 5235, Silver Spring, MD 20993-0002, 301-
796-3937.

SUPPLEMENTARY INFORMATION: FDA is amending 21 CFR 201.25(d)(2) to 
update the address for submitting bar code exemption requests to CDER. 
The new address for these submissions is Office of Compliance, Center 
for Drug Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 51, Silver Spring, MD 20993-0002. 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 submitting bar code exemption requests to CDER.

List of Subjects in 21 CFR Part 201

    Drugs, Labeling, 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 
201 is amended as follows:

PART 201--LABELING

0
1. The authority citation for 21 CFR part 201 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360, 
360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.

0
2. Section 201.25 is amended by revising paragraph (d)(2) to read as 
follows:

Sec.  201.25  Bar code label requirements.

* * * * *
    (d) * * *
    (2) Requests for an exemption should be sent to the Office of 
Compliance, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD 
20993-0002 (requests involving a drug product) or to the Office of 
Compliance and Biologics Quality (HFM-600), Center for Biologics 
Evaluation and Research, Food and Drug Administration, 1401 Rockville 
Pike, Rockville, MD 20852 (requests involving a biological product).

    Dated: March 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5288 Filed 3-8-11; 8:45 am]
BILLING CODE 4160-01-P