Change of Address; Requests for Exemption From the Bar Code Label Requirements, 12847 [2011-5288]

Download as PDF Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Rules and Regulations applicable to the turnbuckles design, and the associated corrective actions required by paragraph (f)(1)(iii) of this AD at intervals not to exceed 110 hours time-in-service or 13 months since the last inspection, whichever occurs first. Issued in Kansas City, Missouri, on February 28, 2011. John Colomy, Acting Manager, Small Airplane Directorate, Aircraft Certification Service. FAA AD Differences BILLING CODE 4910–13–P Note: This AD differs from the MCAI and/ or service information as follows: No differences. mstockstill on DSKH9S0YB1PROD with RULES Other FAA AD Provisions (g) The following provisions also apply to this AD: (1) Alternative Methods of Compliance (AMOCs): The Manager, Standards Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Sarjapur Nagarajan, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329–4145; fax: (816) 329–4090. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO. (2) Airworthy Product: For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAAapproved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service. (3) Reporting Requirements: For any reporting requirement in this AD, a Federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB Control Number. The OMB Control Number for this information collection is 2120–0056. Public reporting for this collection of information is estimated to be approximately 5 minutes per response, including the time for reviewing instructions, completing and reviewing the collection of information. All responses to this collection of information are mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at: 800 Independence Ave., SW., Washington, DC 20591, Attn: Information Collection Clearance Officer, AES–200. Related Information (h) Refer to MCAI European Aviation Safety Agency (EASA) AD No.: 2010–0233, dated November 26, 2010, for related information. VerDate Mar<15>2010 15:00 Mar 08, 2011 Jkt 223001 [FR Doc. 2011–5101 Filed 3–8–11; 8:45 am] 12847 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 1. The authority citation for 21 CFR part 201 continues to read as follows: ■ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 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. 2. Section 201.25 is amended by revising paragraph (d)(2) to read as follows: ■ 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. Final rule; technical amendment. ACTION: 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. SUMMARY: 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. PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 § 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 DEPARTMENT OF TRANSPORTATION Federal Highway Administration 23 CFR Part 460 RIN 2125–AF42 Public Road Mileage for Apportionment of Highway Safety Funds; Correction Federal Highway Administration (FHWA), DOT. ACTION: Correcting amendment. AGENCY: This rule makes a technical correction to the regulations found at 23 CFR 460.2(e). The amendment contained herein makes no substantive change to the FHWA regulations, policies, or procedures. This rule updates the language of a regulatory definition to be consistent with the statutory definition for the Highway Safety Program. DATES: This rule is effective April 8, 2011. SUMMARY: E:\FR\FM\09MRR1.SGM 09MRR1

Agencies

[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

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