74 FR 139 pg. 36111 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications
Type: RULEVolume: 74Number: 139Page: 36111
Docket number: [Docket No. FDA-2009-N-0270]
FR document: [FR Doc. E9-17409 Filed 7-21-09; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520 and 522
[Docket No. FDA-2009-N-0270]
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule.
SUMMARY:
The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of two new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA). In a notice published elsewhere in this issue of the Federal Register , FDA is withdrawing approval of these NADAs and ANADA.
DATES:
This rule is effective August 3, 2009.
FOR FURTHER INFORMATION CONTACT:
John Bartkowiak, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9079, e-mail: john.bartkowiak@fda.hhs.gov .
SUPPLEMENTARY INFORMATION:
The following sponsors have requested that FDA withdraw approval of the two NADAs and ANADA listed in table 1 of this document because the products are no longer manufactured or marketed:
| Sponsor | NADA/ANADA Number Product (Drug) | 21 CFR Cite Affected (Sponsor Drug Labeler Code) |
|---|---|---|
| Wellmark International, 1501 East Woodfield Rd., suite 200, West Schaumburg, IL 60173 | NADA 141-162 Zodiac Fleatrol Flea Caps (S-methoprene) | 520.1390 (011536) |
| IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd., Greensboro, NC 27409 | NADA 141-178 NAVIGATOR Paste (nitazoxanide) | 520.1498 (065274) |
| Abbott Laboratories, North Chicago, IL 60064 | ANADA 200-279 KETAFLO Injection (ketamine HCl, USP) | 522.1222a (000074) |
In a notice published elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADAs 141-162 and 141-178, and ANADA 200-279, and all supplements and amendments thereto, are withdrawn, effective August 3, 2009. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect the withdrawal of approval.
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 in 21 CFR Parts 520 and 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 520 and 522 are amended as follows:
PART 520-ORAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 520 continues to read as follows:
Authority:
21 U.S.C. 360b.
§ 520.1390 [Removed]
2. Remove § 520.1390.
§ 520.1498 [Removed]
3. Remove § 520.1498.
PART 522-IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
4. The authority citation for 21 CFR part 522 continues to read as follows:
Authority:
21 U.S.C. 360b.
§ 522.1222a [Amended]
5. In paragraph (b) of § 522.1222a, remove "000074,".
Dated: July 14, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-17409 Filed 7-21-09; 8:45 am]
BILLING CODE 4160-01-S