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Start Preamble
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule.
SUMMARY:
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Parnell Laboratories (Aust) Pty. Ltd. to Parnell Technologies Pty. Ltd. In addition, the sponsor's mailing address will be changed.
DATES:
This rule is effective April 20, 2010.
Start Further InfoFOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: david.newkirk@fda.hhs.gov.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY INFORMATION:
Parnell Laboratories (Aust) Pty. Ltd., Century Estate, unit 6, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia, has informed FDA that it has changed its name and address to Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect this change.
This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.
Start List of SubjectsList of Subjects in 21 CFR Part 510
- Administrative practice and procedure
- Animal 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 and redelegated to the Center for Veterinary Medicine, 21 CFR part 510 is amended as follows:
End Amendment Part Start PartPART 510—NEW ANIMAL DRUGS
End Part Start Amendment Part1. The authority citation for 21 CFR part 510 continues to read as follows:
End Amendment Part Start Amendment Part2. In § 510.600, in the table in paragraph (c)(1), revise the entry for “Parnell Laboratories (Aust) Pty. Ltd.”; and in the table in paragraph (c)(2), revise the entry for “068504” to read as follows:
End Amendment PartNames, addresses, and drug labeler codes of sponsors of approved applications.(c) * * *
(1) * * *
Firm name and address Drug labeler code * * * * * Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia 068504 * * * * * (2) * * *
Drug labeler code Firm name and address * * * * * 068504 Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia * * * * * Dated: April 15, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 2010-9057 Filed 4-19-10; 8:45 am]
BILLING CODE 4160-01-S
Document Information
- Effective Date:
- 4/20/2010
- Published:
- 04/20/2010
- Department:
- Food and Drug Administration
- Entry Type:
- Rule
- Action:
- Final rule.
- Document Number:
- 2010-9057
- Dates:
- This rule is effective April 20, 2010.
- Pages:
- 20523-20523 (1 pages)
- Docket Numbers:
- Docket No. FDA-2010-N-0002
- Topics:
- Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements
- PDF File:
- 2010-9057.pdf
- CFR: (1)
- 21 CFR 510.600