Document ID: FDA-2008-N-0039-0018
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Change of Sponsors Name; Iron Injection; Technical Amendment
Posted Date: 2008-03-18T04:00Z

[Federal Register: March 18, 2008 (Volume 73, Number 53)]
[Rules and Regulations]               
[Page 14384-14385]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18mr08-7]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522

 
New Animal Drugs; Change of Sponsor's Name; Iron Injection; 
Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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: 
david.newkirk@fda.hhs.gov.

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.

0
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

0
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.

0
2. In Sec.  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:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
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                                * * * * *

[[Page 14385]]

Pharmacosmos, Inc., 776 Mountain               042552
 Blvd.,Watchung, NJ 07069.
                                * * * * *
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    (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

0
3. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

Sec.  522.1182  [Amended]

0
4. In Sec.  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.
[FR Doc. E8-5452 Filed 3-17-08; 8:45 am]

BILLING CODE 4160-01-S