Document ID: FDA-2008-N-0039-0029
Agency: fda
Document Type: Rule
Title: Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of NADAs; Technical Amendment
Posted Date: 2008-04-04T04:00Z

[Federal Register: April 4, 2008 (Volume 73, Number 66)]
[Rules and Regulations]               
[Page 18441-18442]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ap08-8]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 526, and 558

 
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval 
of NADAs; 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 by removing those portions that reflect approval of 
seven new animal drug applications (NADAs) because FDA is withdrawing 
approval of the NADAs.

DATES:  This rule is effective April 4, 2008.

FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for 
Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9067; e-mail: 
pamela.esposito@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The following sponsors have requested that 
FDA withdraw approval of the seven NADAs listed below because the 
products are no longer manufactured or marketed:

------------------------------------------------------------------------
                                                         21 CFR Cite
         Sponsor              NADA Number Product     Affected  (Sponsor
                                    (Drug)            Drug Labeler Code)
------------------------------------------------------------------------
Eon Labs Manufacturing,    NADA 65-063,              520.2345a (000185)
 Inc.,                     Tetracycline capsules
227-15 North Conduit
 Ave.,
Laurelton, NY 11413

                           NADA 65-345,              520.390b (000185)
                           Chloramphenicol capsules
------------------------------------------------------------------------
G.C. Hanford               NADA 65-465,              526.1696a (010515)
 Manufacturing Co.,        AQUA-MAST
P.O. Box 1017,             (penicillin G procaine)
Syracuse, NY 13201
------------------------------------------------------------------------
International Nutrition,   NADA 95-551,              558.625 (043733)
 Inc.,                     TYLAN 5 Premix
7706 ``I'' Plaza,          (tylosin phosphate)
Omaha, NE 68127

                           NADA 109-688,             558.274 (043733)
                           HYGROMIX 2.4 Premix
                           (hygromycin B)

                           NADA 109-816,             558.630 (043733)
                           TYLAN 10 SULFA-G Premix
                           (tylosin phosphate and
                            sulfamethazine)
------------------------------------------------------------------------
Pfizer, Inc.,              NADA 103-758,             Not codified
235 East 42d St.,          TERAMIX-10 Premix
New York, NY 10017         (oxytetracycline)
------------------------------------------------------------------------

    Following the withdrawal of approval of these NADAs, Eon Labs 
Manufacturing, Inc., is no longer sponsor of an approved application. 
Therefore, 21 CFR 510.600(c) is amended to remove entries for this 
sponsor.
    As provided below, the animal drug regulations are amended to 
reflect the withdrawal of approvals. The regulations for penicillin G 
procaine

[[Page 18442]]

intramammary dosage forms (21 CFR 526.1696a) are also amended to 
correct several errors and to reflect a current format.
    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 Parts 520 and 526

    Animal drugs.

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 510, 
520, 526, and 558 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.

Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry 
for ``Eon Labs Manufacturing, Inc.''; and in the table in paragraph 
(c)(2) remove the entry for ``000185''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

Sec.  520.390b  [Amended]

0
4. In Sec.  520.390b, in paragraph (b)(1), remove ``, 000185,''.

Sec.  520.2345a  [Amended]

0
5. In Sec.  520.2345a, remove paragraph (b)(3).

PART 526--INTRAMAMMARY DOSAGE FORMS

0
6. The authority citation for 21 CFR part 526 continues to read as 
follows:

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

0
7. Revise Sec.  526.1696a to read as follows:

Sec.  526.1696a  Penicillin G procaine.

    (a) Specifications. Each 10-milliliter single-dose syringe contains 
penicillin G procaine equivalent to 100,000 units of penicillin G.
    (b) Related tolerances. See Sec.  556.510 of this chapter.
    (c) Sponsors. See Nos. 010515 and 050604 in Sec.  510.600(c) of 
this chapter.
    (d) Conditions of use in lactating cows--(1) Amount. Infuse one 10-
milliliter dose into each infected quarter. Treatment may be repeated 
at 12-hour intervals for not more than three doses, as indicated by 
clinical response.
    (2) Indications for use. For the treatment of mastitis caused by 
Streptococcus agalactiae, S. dysgalactiae, and S. uberus in lactating 
cows.
    (3) Limitations. Milk that has been taken from animals during 
treatment and for 60 hours after the latest treatment must not be used 
for food. Animals must not be slaughtered for food during treatment or 
within 3 days after the latest treatment.
    (e) Conditions of use in dry cows--(1) Amount. Infuse one 10-
milliliter dose into each infected quarter at time of drying-off.
    (2) Indications of use. For the treatment of mastitis caused by 
Streptococcus agalactiae in dry cows.
    (3) Limitations. Discard all milk for 72 hours (6 milkings) 
following calving, or later as indicated by the marketable quality of 
the milk. Animals must not be slaughtered for food within 14 days 
postinfusion.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
8. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

Sec.  558.274  [Amended]

0
9. In Sec.  558.274, amend paragraph (a)(2) by removing ``Nos. 043733 
and'' and adding in its place ``No.''.

Sec.  558.625  [Amended]

0
10. In Sec.  558.625, remove and reserve paragraph (b)(3).

Sec.  558.630  [Amended]

0
11. In Sec.  558.630, amend paragraph (b)(10) by removing ``043733,''.

    Dated: March 26, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-7103 Filed 4-3-08; 8:45 am]

BILLING CODE 4160-01-S