Skip to Content

Rule

Implantation or Injectable Dosage From New Animal Drugs; Change of Sponsor; Repository Corticotropin Injection

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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 Summit Hill Laboratories to Putney, Inc.

DATES:

This rule is effective May 5, 2009.

Start Further Info

FOR 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 Information

SUPPLEMENTARY INFORMATION:

Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 8-760 for ADRENOMONE (repository corticotropin injection U.S.P.) to Putney, Inc., 400 Congress St., suite 200, Portland, ME 04101. Accordingly, the regulations are amended in 21 CFR 522.480 to reflect this change of sponsorship.

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 Subjects

List of Subjects in 21 CFR Part 522

End List of Subjects Start Amendment Part

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,

End Amendment Part Start Part

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

1. The authority citation for

End Amendment Part Start Authority

Authority: 21 U.S.C. 360b.

End Authority
[Amended]
Start Amendment Part

2. In paragraph (a)(2) of § 522.480, remove “037990” and add in its place “026637”.

End Amendment Part Start Signature

Dated: April 30, 2009.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

End Signature End Supplemental Information

[FR Doc. E9-10291 Filed 5-4-09; 8:45 am]

BILLING CODE 4160-01-S