Animal Drugs, Feeds, and Related Products; Withdrawals of Approvals of New Animal Drug Applications:
Federal Register: October 26, 2010 (Volume 75, Number 206)
Rules and Regulations
Page 65565-65566
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr26oc10-2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration 21 CFR Parts 520, 556, and 558
Docket No. FDA-2010-N-0002
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride;
Nitromide and Sulfanitran
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 eight new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.
DATES: This rule is effective November 5, 2010.
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: Fort Dodge Animal Health, a Division of
Wyeth Holdings, a Wholly Owned Subsidiary of Pfizer, Inc., 235 East 42d
St., New York, NY 10017 has requested that FDA withdraw approval of the eight NADAs listed in Table 1 of this document because they are no longer manufactured or marketed.
Table 1
NADA No.
Product
Established name of drug(s)
NADA 11-141.................... UNISTAT-2 Type A
nitromide and sulfanitran. medicated article.
NADA 14-250.................... NOVASTAT Type A
aklomide and sulfanitran. medicated article.
NADA 34-536.................... ALKOMIX Type A
aklomide. medicated article. aklomide, sulfanitran, and roxarsone.
ALKOMIX-3 Type A medicated article.
NADA 34-537.................... NOVASTAT-3 Type A
aklomide, sulfanitran, and roxarsone. medicated article.
NADA 35-388.................... NOVASTAT-W Soluble aklomide and sulfanitran.
Powder.
NADA 39-666.................... UNISTAT-3 Type A
nitromide, sulfanitran, and roxarsone. medicated article.
NADA 44-015.................... TRAMISOL Type A
levamisole. medicated article.
NADA 45-455.................... TRAMISOL Type A
levamisole. medicated article.
In a notice published elsewhere in this issue of the Federal
Register, FDA gave notice that approval of NADA 11-141, 14-250, 34-536, 34-537, 35-388, 39-666, 44-015, and 45-455, and all supplements and amendments thereto, is withdrawn, effective November 5, 2010. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these withdrawals 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 21 CFR Part 520
Animal drugs. 21 CFR Part 556
Animal drugs, Foods. 21 CFR Part 558
Animal drugs, Animal feeds. 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 520, 556, and 558 are amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 0 1. The authority citation for 21 CFR part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.2320 [Removed] 0 2. Remove Sec. 520.2320.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 0 3. The authority citation for 21 CFR part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
Sec. 556.30 [Removed] 0 4. Remove Sec. 556.30.
Page 65566
Sec. 556.220 [Removed] 0 5. Remove Sec. 556.220.
Sec. 556.680 [Removed] 0 6. Remove Sec. 556.680.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 7. The authority citation for 21 CFR part 558 continues to read as follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.4 [Amended] 0 8. In Sec. 558.4, in paragraph (d), in the ``Category I'' table, remove the listing for ``Aklomide''; and in the ``Category II'' table, remove the listings for ``Levamisole'', ``Nitromide'' immediately followed in sequence by ``Sulfanitran'', ``Nitromide'' immediately followed in sequence by ``Sulfanitran'' and by ``Roxarsone'';
``Sulfanitran'' immediately followed in sequence by ``Aklomide'', and the two listings for ``Sulfanitran'' immediately followed in sequence by ``Aklomide'' and by ``Roxarsone''.
Sec. 558.35 [Removed] 0 9. Remove Sec. 558.35.
Sec. 558.315 [Removed] 0 10. Remove Sec. 558.315.
Sec. 558.376 [Removed] 0 11. Remove Sec. 558.376.
Dated: October 8, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
FR Doc. 2010-27011 Filed 10-25-10; 8:45 am
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