New Animal Drugs; Enrofloxacin; Tylvalosin, 55414-55415 [2012-22194]
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55414
Federal Register / Vol. 77, No. 175 / Monday, September 10, 2012 / Rules and Regulations
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.
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
List of Subjects
§ 522.1081
21 CFR Part 510
[Amended]
4. In § 522.1081, remove and reserve
paragraph (b)(2).
■
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
§ 522.1462
21 CFR Part 522
§ 522.1642
■
■
Animal drugs.
[Removed]
5. Remove § 522.1462.
[Removed]
6. Remove § 522.1642.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR parts 510 and 522 are amended as
follows:
§ 522.1680
PART 510—NEW ANIMAL DRUGS
BILLING CODE 4160–01–P
1. The authority citation for 21 CFR
part 510 continues to read as follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
Food and Drug Administration
§ 510.600
21 CFR Parts 520, 522, and 556
■
[Amended]
2. In § 510.600, in the table in
paragraph (c)(1), remove the entries for
‘‘Endo Pharmaceuticals Inc.’’ and
‘‘United Vaccines, A Harlan Sprague
Dawley, Inc., Co.’’; and in the table in
paragraph (c)(2), remove the entries for
‘‘058639’’ and ‘‘060951’’.
■
[Amended]
Dated: September 5, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012–22196 Filed 9–7–12; 8:45 am]
[Docket No. FDA–2012–N–0002]
New Animal Drugs; Enrofloxacin;
Tylvalosin
Food and Drug Administration,
HHS.
ACTION:
FDA is
amending the animal drug regulations to
reflect original and supplemental
approval actions during July 2012, as
listed in table 1. 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: https://www.fda.gov/AboutFDA/
CentersOffices/OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm.
SUPPLEMENTARY INFORMATION:
7. In § 522.1680, in paragraph (b),
remove ‘‘058639,’’.
■
AGENCY:
animal drug regulations to reflect
approval actions for new animal drug
applications (NADAs) and abbreviated
new animal drug applications
(ANADAs) during July 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 September
10, 2012.
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,
george.haibel@fda.hhs.gov.
Final rule.
The Food and Drug
Administration (FDA) is amending the
SUMMARY:
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY 2012
Sponsor
New animal
drug product
name
141–336 ............
ECO LLC, 8209
Hollister
Ave., Las
Vegas, NV
89131.
AIVLOSIN
(tylvalosin
tartrate)
Water Soluble Granules.
141–068 ............
wreier-aviles on DSK5TPTVN1PROD with RULES
NADA/ANADA
Bayer
HealthCare
LLC, Animal
Health Division, P.O.
Box 390,
Shawnee
Mission, KS
66201.
BAYTRIL 100
(enrofloxacin)
Injectable Solution.
VerDate Mar<15>2010
13:46 Sep 07, 2012
Jkt 226001
PO 00000
Action
Original approval for control of
porcine
proliferative
enteropathy (PPE) associated
with
Lawsonia
intracellularis infection in
groups of swine in buildings
experiencing an outbreak of
PPE.
Supplement adding control of
bovine respiratory disease
(BRD) in beef and non-lactating dairy cattle at high risk
of developing BRD associated
with
Mannheimia
haemolytica,
Pasteurella
multocida, Histophilus somni
and Mycoplasma bovis; and
revising a food safety warning statement.
Frm 00004
Fmt 4700
Sfmt 4700
FOIA
summary
21 CFR section
NEPA
review
520.2645
556.748
yes ..................
CE 1
522.812
yes ..................
CE 1
E:\FR\FM\10SER1.SGM
10SER1
Federal Register / Vol. 77, No. 175 / Monday, September 10, 2012 / Rules and Regulations
55415
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY 2012—Continued
New animal
drug product
name
NADA/ANADA
Sponsor
200–482 ............
Cross
VetPharm
Group, Ltd.,
Broomhill
Rd., Tallaght,
Dublin 24,
Ireland.
AMPROMED
for Calves
(amprolium)
9.6% Oral
Solution.
Action
FOIA
summary
21 CFR section
Original approval as a generic
copy of NADA 13–149.
520.100
yes ..................
NEPA
review
CE 1
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 Parts 520 and 522
Animal drugs.
21 CFR Part 556
Animal drugs, Food.
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, 522, and 556 are
amended as follows:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
Authority: 21 U.S.C. 360b.
2. In § 520.100, revise paragraph (b)(4)
to read as follows:
Amprolium.
*
*
*
*
*
(b) * * *
(4) No. 061623 for use of product
described in paragraph (a)(1) of this
section as in paragraph (d)(2); and for
use of product described in paragraph
(a)(2) of this section as in paragraphs
(d)(1) and (d)(2) of this section.
*
*
*
*
*
■ 3. Add § 520.2645 to read as follows:
wreier-aviles on DSK5TPTVN1PROD with RULES
Tylvalosin.
(a) Specifications. Granules
containing 62.5 percent tylvalosin (w/w)
as tylvalosin tartrate.
(b) Sponsor. See No. 066916 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 556.748
of this chapter.
(d) Conditions of use in swine—(1)
Amount. Administer 50 parts per
VerDate Mar<15>2010
13:46 Sep 07, 2012
Jkt 226001
4. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
5. In 522.812, revise paragraphs
(e)(2)(i), (e)(2)(ii)(A), and (e)(2)(iii) to
read as follows:
■
Enrofloxacin.
*
■
§ 520.2645
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
§ 522.812
1. The authority citation for 21 CFR
part 520 continues to read as follows:
■
§ 520.100
million tylvalosin in drinking water for
5 consecutive days.
(2) Indications for use. For the control
of porcine proliferative enteropathy
(PPE) associated with Lawsonia
intracellularis infection in groups of
swine in buildings experiencing an
outbreak of PPE.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
*
*
*
*
(e) * * *
(2) * * *
(i) Amount—(A) Single-dose therapy:
For treatment of bovine respiratory
disease (BRD), administer 7.5 to 12.5
mg/kg of body weight (3.4 to 5.7 mL per
100 pounds (/100 lb)) once by
subcutaneous injection. For control of
BRD, administer 7.5 mg/kg of body
weight (3.4 mL/100 lb) once by
subcutaneous injection.
(B) Multiple-day therapy: For
treatment of BRD, administer 2.5 to 5.0
mg/kg of body weight (1.1 to 2.3 mL/100
lb) by subcutaneous injection.
Treatment should be repeated at 24hour intervals for 3 days. Additional
treatments may be given on days 4 and
5 to animals that have shown clinical
improvement but not total recovery.
(ii) Indications for use—(A) Singledose therapy: For the treatment of BRD
associated with Mannheimia
haemolytica, Pasteurella multocida,
Histophilus somni, and Mycoplasma
bovis in beef and non-lactating dairy
cattle; for the control of BRD in beef and
PO 00000
Frm 00005
Fmt 4700
Sfmt 9990
non-lactating dairy cattle at high risk of
developing BRD associated with M.
haemolytica, P. multocida, H. somni
and M. bovis.
*
*
*
*
*
(iii) Limitations. Animals intended for
human consumption must not be
slaughtered within 28 days from the last
treatment. This product is not approved
for female dairy cattle 20 months of age
or older, including dry dairy cows. Use
in these cattle may cause drug residues
in milk and/or in calves born to these
cows. A withdrawal period has not been
established for this product in
preruminating calves. Do not use in
calves to be processed for veal.
*
*
*
*
*
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
6. The authority citation for 21 CFR
part 556 continues to read as follows:
■
Authority: 21 U.S.C. 342, 360b, 371.
■
7. Add § 556.748 to read as follows:
§ 556.748
Tylvalosin.
(a) Acceptable Daily Intake (ADI). The
ADI for total residues of tylvalosin is
47.7 micrograms per kilogram of body
weight per day.
(b) Tolerances. A tolerance for
tylvalosin in edible tissues of swine is
not required.
(c) Related conditions of use. See
§ 520.2645 of this chapter.
Dated: September 5, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012–22194 Filed 9–7–12; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\10SER1.SGM
10SER1
]]>Agencies
[Federal Register Volume 77, Number 175 (Monday, September 10, 2012)]
[Rules and Regulations]
[Pages 55414-55415]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22194]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 522, and 556
[Docket No. FDA-2012-N-0002]
New Animal Drugs; Enrofloxacin; Tylvalosin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval actions for new animal drug
applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during July 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 September 10, 2012.
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,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect original and supplemental approval actions during July 2012,
as listed in table 1. 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: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.
Table 1--Original and Supplemental NADAs and ANADAs Approved During July 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
New animal drug
NADA/ANADA Sponsor product name Action 21 CFR section FOIA summary NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-336................ ECO LLC, 8209 AIVLOSIN Original approval for 520.2645 yes.................. CE \1\
Hollister Ave., (tylvalosin control of porcine 556.748
Las Vegas, NV tartrate) Water proliferative
89131. Soluble Granules. enteropathy (PPE)
associated with
Lawsonia
intracellularis
infection in groups of
swine in buildings
experiencing an
outbreak of PPE.
141-068................ Bayer HealthCare BAYTRIL 100 Supplement adding 522.812 yes.................. CE \1\
LLC, Animal (enrofloxacin) control of bovine
Health Division, Injectable respiratory disease
P.O. Box 390, Solution. (BRD) in beef and non-
Shawnee Mission, lactating dairy cattle
KS 66201. at high risk of
developing BRD
associated with
Mannheimia
haemolytica,
Pasteurella multocida,
Histophilus somni and
Mycoplasma bovis; and
revising a food safety
warning statement.
[[Page 55415]]
200-482................ Cross VetPharm AMPROMED for Original approval as a 520.100 yes.................. CE \1\
Group, Ltd., Calves generic copy of NADA
Broomhill Rd., (amprolium) 9.6% 13-149.
Tallaght, Dublin Oral Solution.
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 Parts 520 and 522
Animal drugs.
21 CFR Part 556
Animal drugs, Food.
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,
522, and 556 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) to read as follows:
Sec. 520.100 Amprolium.
* * * * *
(b) * * *
(4) No. 061623 for use of product described in paragraph (a)(1) of
this section as in paragraph (d)(2); and for use of product described
in paragraph (a)(2) of this section as in paragraphs (d)(1) and (d)(2)
of this section.
* * * * *
0
3. Add Sec. 520.2645 to read as follows:
Sec. 520.2645 Tylvalosin.
(a) Specifications. Granules containing 62.5 percent tylvalosin (w/
w) as tylvalosin tartrate.
(b) Sponsor. See No. 066916 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.748 of this chapter.
(d) Conditions of use in swine--(1) Amount. Administer 50 parts per
million tylvalosin in drinking water for 5 consecutive days.
(2) Indications for use. For the control of porcine proliferative
enteropathy (PPE) associated with Lawsonia intracellularis infection in
groups of swine in buildings experiencing an outbreak of PPE.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
4. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
5. In 522.812, revise paragraphs (e)(2)(i), (e)(2)(ii)(A), and
(e)(2)(iii) to read as follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(e) * * *
(2) * * *
(i) Amount--(A) Single-dose therapy: For treatment of bovine
respiratory disease (BRD), administer 7.5 to 12.5 mg/kg of body weight
(3.4 to 5.7 mL per 100 pounds (/100 lb)) once by subcutaneous
injection. For control of BRD, administer 7.5 mg/kg of body weight (3.4
mL/100 lb) once by subcutaneous injection.
(B) Multiple-day therapy: For treatment of BRD, administer 2.5 to
5.0 mg/kg of body weight (1.1 to 2.3 mL/100 lb) by subcutaneous
injection. Treatment should be repeated at 24-hour intervals for 3
days. Additional treatments may be given on days 4 and 5 to animals
that have shown clinical improvement but not total recovery.
(ii) Indications for use--(A) Single-dose therapy: For the
treatment of BRD associated with Mannheimia haemolytica, Pasteurella
multocida, Histophilus somni, and Mycoplasma bovis in beef and non-
lactating dairy cattle; for the control of BRD in beef and non-
lactating dairy cattle at high risk of developing BRD associated with
M. haemolytica, P. multocida, H. somni and M. bovis.
* * * * *
(iii) Limitations. Animals intended for human consumption must not
be slaughtered within 28 days from the last treatment. This product is
not approved for female dairy cattle 20 months of age or older,
including dry dairy cows. Use in these cattle may cause drug residues
in milk and/or in calves born to these cows. A withdrawal period has
not been established for this product in preruminating calves. Do not
use in calves to be processed for veal.
* * * * *
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
6. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
7. Add Sec. 556.748 to read as follows:
Sec. 556.748 Tylvalosin.
(a) Acceptable Daily Intake (ADI). The ADI for total residues of
tylvalosin is 47.7 micrograms per kilogram of body weight per day.
(b) Tolerances. A tolerance for tylvalosin in edible tissues of
swine is not required.
(c) Related conditions of use. See Sec. 520.2645 of this chapter.
Dated: September 5, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-22194 Filed 9-7-12; 8:45 am]
BILLING CODE 4160-01-P
