[Federal Register Volume 78, Number 1 (Wednesday, January 2, 2013)]
[Rules and Regulations]
[Pages 22-25]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-31234]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 558

[Docket No. FDA-2012-N-0002]


New Animal Drugs; Meloxicam; Nicarbazin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect

[[Page 23]]

approval actions for new animal drug applications (NADAs) and 
abbreviated new animal drug applications (ANADAs) during October 2012. 
FDA is also informing the public of the availability of summaries of 
the basis of approval and of environmental review documents, where 
applicable.

DATES: This rule is effective January 2, 2013.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9019, 
[email protected].

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations 
to reflect original and supplemental approval actions during October 
2012, as listed in table 1 of this document. In addition, FDA is 
informing the public of the availability, where applicable, of 
documentation of environmental review required under the National 
Environmental Policy Act (NEPA) and, for actions requiring review of 
safety or effectiveness data, summaries of the basis of approval (FOI 
Summaries) under the Freedom of Information Act (FOIA). These public 
documents may be seen in the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons 
with access to the Internet may obtain these documents at the Center 
for Veterinary Medicine FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.

                                    Table 1--Original and Supplemental NADAs and ANADAs Approved During October 2012
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                                                            New animal drug                            21 CFR
            NADA/ANADA                    Sponsor            product name             Action          section       FOIA summary         NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
009-476..........................  Phibro Animal Health  NICARB 25%            Supplement revising     558.366  No.................  CE \1\
                                    Corp., GlenPointe     (nicarbazin) Type A   nicarbazin dosage
                                    Centre East, Third    medicated article.    to a range
                                    floor, 300 Frank W.                         consistent with
                                    Burr Blvd., suite                           dosage approved for
                                    21, Teaneck, NJ                             use in combination
                                    07666.                                      feeds.
098-378..........................  Phibro Animal Health  NICARB 25%            Supplement revising     558.366  No.................  CE \1\
                                    Corp., GlenPointe     (nicarbazin) and      nicarbazin dosage
                                    Centre East, Third    bacitracin            to a range
                                    floor, 300 Frank W.   methylene             consistent with
                                    Burr Blvd., suite     disalicylate Type A   dosage approved for
                                    21, Teaneck, NJ       medicated articles.   use in combination
                                    07666.                                      feeds.
200-496..........................  Cross Vetpharm Group  AMPROMED P for        Original approval as    520.100  Yes................  CE \1\
                                    Ltd., Broomhill       Poultry (amprolium)   a generic copy of
                                    Rd., Tallaght,        9.6% Oral Solution.   NADA 13-149.
                                    Dublin 24, Ireland.
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\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental
  assessment or an environmental impact statement because it is of a type that does not individually or cumulatively have a significant effect on the
  human environment.

    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 558

    Animal drugs, Animal feeds.

    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 
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.


0
2. In Sec.  520.100, revise paragraph (b)(4) and the introductory text 
in paragraph (d)(1) to read as follows:


Sec.  520.100  Amprolium.

* * * * *
    (b) * * *
    (4) No. 061623 for use of products described in paragraphs (a)(1) 
and (a)(2) of this section as in paragraph (d) of this section.
* * * * *
    (d) * * * (1) Growing chickens, turkeys, and laying hens. It is 
used in drinking water as follows:
* * * * *

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

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

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


0
4. In Sec.  558.366, in paragraph (d), amend the table as follows:
0
a. Revise the entries for ``90.8 to 181.6 (0.01 to 0.02 pct)''.
0
b. In the entry for ``113.5 (0.0125 pct)'', in the entry for 
``Chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and 
intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti)

[[Page 24]]

coccidiosis'', remove ``066104'' from the ``Sponsor'' column.
0
c. In the entry for ``113.5 (0.0125 pct)'', in the entry for 
``Bacitracin methylene disalicylate 30'', remove ``066104'' from the 
``Sponsor'' column.
    The revisions read as follows:


Sec.  558.366  Nicarbazin.

* * * * *
    (d) * * *

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                                      Combination in  grams
    Nicarbazin in  grams per ton             per ton                   Indications for use                          Limitations                 Sponsor
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                                                                      * * * * * * *
90.8 to 181.6 (0.01 to 0.02 pct)...  ......................  Broiler chickens: As an aid in           Feed continuously as sole ration from       066104
                                                              preventing outbreaks of cecal (Eimeria   time chicks are placed on litter until
                                                              tenella) and intestinal (E.              past the time when coccidiosis is
                                                              acervulina, E. maxima, E. necatrix,      ordinarily a hazard. Do not use as a
                                                              and E. brunetti) coccidiosis.            treatment for coccidiosis. Do not feed
                                                                                                       to laying hens. Withdraw 4 days before
                                                                                                       slaughter for use levels at or below
                                                                                                       113.5 g/ton. Withdraw 5 days before
                                                                                                       slaughter for use levels above 113.5 g/
                                                                                                       ton.
                                     Bacitracin methylene    Broiler chickens: As an aid in           Feed continuously as sole ration from       066104
                                      disalicylate 4 to 50    preventing outbreaks of cecal (Eimeria   time chicks are placed on litter until
                                      and roxarsone 22.7 to   tenella) and intestinal (E.              past the time when coccidiosis is
                                      45.4.                   acervulina, E. maxima, E. necatrix,      ordinarily a hazard; do not use as a
                                                              and E. brunetti) coccidiosis; and for    treatment for outbreaks of
                                                              increased rate of weight gain and        coccidiosis. Discontinue medication 5
                                                              improved feed efficiency.                days before marketing the birds for
                                                                                                       human consumption to allow for
                                                                                                       elimination of the drug from edible
                                                                                                       tissue. Do not feed to laying hens in
                                                                                                       production. Nicarbazin as provided by
                                                                                                       No. 066104; bacitracin methylene
                                                                                                       disalicylate and roxarsone by No.
                                                                                                       046573 in Sec.   510.600(c) of this
                                                                                                       chapter.
                                     Bacitracin methylene    Broiler chickens: As an aid in           Feed continuously as sole ration from       066104
                                      disalicylate 30.        preventing outbreaks of cecal (Eimeria   time chicks are placed on litter until
                                                              tenella) and intestinal (E.              past the time when coccidiosis is
                                                              acervulina, E. maxima, E. necatrix,      ordinarily a hazard. Do not use as a
                                                              and E. brunetti) coccidiosis; and for    treatment for coccidiosis. Do not feed
                                                              increased rate of weight gain and        to laying hens. Withdraw 4 days before
                                                              improved feed efficiency.                slaughter for use levels at or below
                                                                                                       113.5 g/ton. Withdraw 5 days before
                                                                                                       slaughter for use levels above 113.5 g/
                                                                                                       ton.
                                     Penicillin 2.4 to 50..  Broiler chickens: As an aid in           Feed continuously as sole ration from       066104
                                                              preventing outbreaks of cecal (Eimeria   time chicks are placed on litter until
                                                              tenella) and intestinal (E.              past the time when coccidiosis is
                                                              acervulina, E. maxima, E. necatrix,      ordinarily a hazard; do not use as a
                                                              and E. brunetti) coccidiosis, and for    treatment for outbreaks of
                                                              increased rate of weight gain and        coccidiosis. Do not use in flushing
                                                              improved feed efficiency.                mashes. Do not feed to chickens
                                                                                                       producing eggs for human consumption.
                                                                                                       Discontinue medication 5 days before
                                                                                                       marketing the birds for human
                                                                                                       consumption to allow for elimination
                                                                                                       of the drug from edible tissue.
                                                                                                       Penicillin as procaine penicillin G.
                                                                                                       Nicarbazin and penicillin as provided
                                                                                                       by No. 066104 in Sec.   510.600(c) of
                                                                                                       this chapter.

[[Page 25]]

 
                                     Penicillin 2.4 to 50    Broiler chickens: As an aid in           Feed continuously as sole ration from       066104
                                      and roxarsone 22.7 to   preventing outbreaks of cecal (Eimeria   time chicks are placed on litter until
                                      45.4.                   tenella) and intestinal (E.              past the time when coccidiosis is
                                                              acervulina, E. maxima, E. necatrix,      ordinarily a hazard; do not use as a
                                                              and E. brunetti) coccidiosis, and for    treatment for outbreaks of
                                                              increased rate of weight gain and        coccidiosis. Feed as the sole source
                                                              improved feed efficiency, and improved   of organic arsenic; drug overdose or
                                                              pigmentation.                            lack of water may result in leg
                                                                                                       weakness; do not use in flushing
                                                                                                       mashes. Discontinue medication 5 days
                                                                                                       before marketing the birds for human
                                                                                                       consumption to allow for elimination
                                                                                                       of the drug from edible tissue. Do not
                                                                                                       feed to laying hens in production.
                                                                                                       Penicillin as procaine penicillin G.
                                                                                                       Nicarbazin and penicillin as provided
                                                                                                       by No. 066104; roxarsone by No. 046573
                                                                                                       in Sec.   510.600(c) of this chapter.
 
                                                                      * * * * * * *
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    Dated: December 21, 2012
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-31234 Filed 12-31-12; 8:45 am]
BILLING CODE 4160-01-P