Document ID: FDA-2010-N-0002-0073
Agency: fda
Document Type: Rule
Title: Animal Drugs, Feeds, and Related Products; Withdrawals of Approvals of New Animal Drug Applications: Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran
Posted Date: 2010-10-26T04:00Z

[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]
BILLING CODE 4160-01-P