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