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Daily Rules, Proposed Rules, and Notices of the Federal Government

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 529

[Docket No. FDA-2010-N-0002]

New Animal Drugs; Change of Sponsor's Name and Address; Corrections

AGENCY: Food and Drug Administration, HHS.
ACTION: Correcting amendments.
SUMMARY: The Food and Drug Administration (FDA) published a document in theFederal Registerof April 20, 2010 (75 FR 20522) amending the animal drug regulations to reflect changes to a sponsor's name and address. That document contained errors in the regulatory text. FDA is correcting the tables listing sponsors of approved animal drug applications (NADAs) by adding a change to the sponsor's drug labeler code (DLC). Cross-references to the sponsor's DLC are amended in two sections of the Code of Federal Regulations (CFR) containing the conditions of use approved animal drug products. These corrections are being made to improve the accuracy of the animal drug regulations.
DATES: This rule is effective March 24, 2011.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration,7519 Standish Pl., Rockville, MD 20855, 240-276-9019, e-mail:george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:

The Food and Drug Administration (FDA) published a document in theFederal Registerof April 20, 2010 (75 FR 20522) amending the animal drug regulations to reflect changes to a sponsor's name and address. That document contained errors in the regulatory text. FDA is correcting the tables listing sponsors of approved animal drug applications (NADAs) by adding a change to the sponsor's drug labeler code (DLC). Cross-references to the sponsor's DLC are amended in two sections of the Code of Federal Regulations (CFR) containing the conditions of use approved animal drug products. These corrections are being made to improve the accuracy of the animal drug regulations.

List of Subjects 21 CFR Part 510

Administrative practice and procedure, Animal drugs, Labeling, Reporting and Recordkeeping requirements.

21 CFR Part 529

Animal drugs.

Accordingly, 21 CFR parts 510 and 529 are corrected by making the following correcting amendments:

PART 510—NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: Authority:

21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

2. In § 510.600, in the table in paragraph (c)(1), revise the entry for “Piramal Critical Care, Inc.”; and in the table in paragraph (c)(2), remove the
entry for “060307” and in numerical sequence, add an entry for “066794” to read as follows:
§ 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.

(c) * * *

(1) * * *

Firm name and address Drug labeler code ***** Piramal Critical Care, Inc., 3850 Schelden Circle, Bethlehem, PA 18017 066794 *****

(2) * * *

Drug
  • labeler code
  • Firm name and address
    ***** 066794 Piramal Critical Care, Inc., 3850 Schelden Circle, Bethlehem, PA 18017. *****
    PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 529 continues to read as follows: Authority:

    21 U.S.C. 360b.

    § 529.1186 [Corrected]
    4. In paragraph (b) of § 529.1186, remove “060307, and 065085” and in its place add “065085, and 066794”.
    § 529.2150 [Corrected]
    5. In paragraph (b) of § 529.2150, remove “060307” and in its place add “066794”. Dated: March 17, 2011. Leslie Kux, Acting Assistant Commissioner for Policy.