E8-5452. New Animal Drugs; Change of Sponsor's Name; Iron Injection; Technical Amendment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Animal Health Pharmaceuticals, LLC, to Pharmacosmos, Inc.

DATES:

This rule is effective March 18, 2008.

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: [e-mail].

SUPPLEMENTARY INFORMATION:

Animal Health Pharmaceuticals, LLC, 1805 Oak Ridge Circle, suite 101, St. Joseph, MO 64506, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 106-772 for Iron-GARD Injection 100 milligrams per milliliter (mg/mL) and NADA 134-708 for Iron-GARD Injection 200 mg/mL to Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ 07069. Accordingly, the regulations are amended in 21 CFR 522.1182 to reflect these changes of sponsorship.

In addition, Pharmacosmos, Inc., is not currently listed in the animal drug regulations as a sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to add entries for Pharmacosmos, Inc.

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.

List of Subjects

21 CFR Part 510

• Administrative practice and procedure
• Animal drugs
• Labeling
• Reporting and recordkeeping requirements

21 CFR Part 522

• Animal drugs

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 parts 510 and 522 are amended as follows:

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) alphabetically add a new entry for “Pharmacosmos, Inc.”; and in the table in paragraph (c)(2) numerically add a new entry for “042552” 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
*    *    *    *    *
Pharmacosmos, Inc., 776 Mountain Blvd.,Watchung, NJ 07069	042552
*    *    *    *    *

(2) * * *

Drug labeler code	Firm name and address
*    *    *    *    *
042552	Pharmacosmos, Inc., 776 Mountain Blvd.,Watchung, NJ 07069
*    *    *    *    *

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

3. The authority citation for 21 CFR part 522 continues to read as follows:

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

§ 522.1182

[Amended]

4. In § 522.1182, in paragraphs (b)(1) and (b)(7) remove “059130 and 068718” and add in its place “042552 and 059130”.

Dated: March 6, 2008.

Bernadette Dunham,

Director, Center for Veterinary Medicine.