[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combination in grams
Nicarbazin in grams per ton per ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
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.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
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