New Animal Drugs; Gamithromycin, 57906-57907 [2011-23874]
Download as PDF
<![CDATA[
57906
Federal Register / Vol. 76, No. 181 / Monday, September 19, 2011 / Rules and Regulations
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an abbreviated new animal
drug application (ANADA) filed by
Cross Vetpharm Group Ltd. The
ANADA provides for use of an
ivermectin injectable solution for
treatment and control of various internal
and external parasites in cattle, swine,
reindeer, and American bison.
DATES: This rule is effective September
19, 2011.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–170), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Cross
Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed
ANADA 200–447 for the use of
BIMECTIN (ivermectin) Injection for
Cattle and Swine for treatment and
control of various internal and external
parasites in cattle, swine, reindeer, and
American bison. Cross Vetpharm Group
Ltd.’s BIMECTIN Injection for Cattle and
Swine is approved as a generic copy of
Merial Ltd.’s IVOMEC (ivermectin)
Injection for Cattle and Swine, approved
under NADA 128–409. The ANADA is
approved as of July 5, 2011, and the
regulations in 21 CFR 522.1192 are
amended to reflect the approval.
A summary of safety and effectiveness
data and information submitted to
support approval of this application
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.
FDA has determined under 21 CFR
25.33 that this action is of a type that
does not individually or cumulatively
have a significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
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.
tkelley on DSKG8SOYB1PROD with RULES
SUMMARY:
List of Subjects in 21 CFR Part 522
Animal drugs.
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 part 522 is amended as follows:
VerDate Mar<15>2010
13:21 Sep 16, 2011
Jkt 223001
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
2. In § 522.1192, revise paragraph
(b)(2) to read as follows:
■
§ 522.1192
Ivermectin.
*
*
*
*
*
(b) * * *
(2) Nos. 055529, 058005, 059130, and
061623 for use of the product described
in paragraph (a)(2) of this section as in
paragraphs (e)(2), (e)(3), (e)(4), and (e)(5)
of this section.
*
*
*
*
*
Dated: September 13, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011–23865 Filed 9–16–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 522 and 556
[Docket No. FDA–2011–N–0003]
New Animal Drugs; Gamithromycin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an original new animal drug
application (NADA) filed by Merial, Ltd.
The NADA provides for the veterinary
prescription use of gamithromycin
injectable solution for the management
of bovine respiratory disease (BRD).
FDA is also amending the regulations to
add the established tolerances for
residues of gamithromycin in edible
tissues of cattle.
DATES: This rule is effective September
19, 2011.
FOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV–130), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–276–
8341, e-mail:
cindy.burnsteel@fda.hhs.gov.
SUMMARY:
Merial
Ltd., 3239 Satellite Blvd., Bldg. 500,
Duluth, GA 30096–4640 filed NADA
141–328 that provides for the veterinary
prescription use of ZACTRAN
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
(gamithromycin), an injectable solution,
in beef and non-lactating dairy cattle for
the treatment of BRD associated with
Mannheimia haemolytica, Pasteurella
multocida, and Histophilus somni; and
for the control of respiratory disease in
beef and non-lactating dairy cattle at
high risk of developing BRD associated
with M. haemolytica and P. multocida.
The application is approved as of June
16, 2011, and the regulations are
amended in 21 CFR parts 522 and 556
to reflect the approval.
A summary of safety and effectiveness
data and information submitted to
support approval of this application
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.
Under section 512(c)(2)(F)(i) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(i)), this
approval qualifies for 5 years of
marketing exclusivity beginning on the
date of approval.
The Agency has determined under 21
CFR 25.33 that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
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 522
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
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 522 and 556 are amended as
follows:
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
2. Section 522.1014 is added to read
as follows:
■
E:\FR\FM\19SER1.SGM
19SER1
Federal Register / Vol. 76, No. 181 / Monday, September 19, 2011 / Rules and Regulations
§ 522.1014
Gamithromycin.
(a) Specifications. Each milliliter (mL)
of solution contains 150 milligrams (mg)
gamithromycin.
(b) Sponsor. See No. 050604 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 556.292
of this chapter.
(d) Conditions of use—(1) Cattle—(i)
Amount. Administer 6 mg/kilogram of
body weight (2 mL per 110 pounds) one
time by subcutaneous injection in the
neck.
(ii) Indications for use. For the
treatment of bovine respiratory disease
(BRD) associated with Mannheimia
haemolytica, Pasteurella multocida, and
Histophilus somni in beef and nonlactating dairy cattle; and for the control
of respiratory disease in beef and nonlactating dairy cattle at high risk of
developing BRD associated with M.
haemolytica and P. multocida.
(iii) Limitations. Cattle intended for
human consumption must not be
slaughtered within 35 days from the last
treatment. Do not use in female dairy
cattle 20 months of age or older. A
withdrawal period has not been
established for this product in
preruminating calves. Do not use in
calves to be processed for veal. Federal
law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) [Reserved]
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
3. The authority citation for 21 CFR
part 556 continues to read as follows:
■
Authority: 21 U.S.C. 342, 360b, 371.
4. Section 556.292 is added to read as
follows:
■
tkelley on DSKG8SOYB1PROD with RULES
§ 556.292
Gamithromycin.
(a) Acceptable Daily Intake (ADI). The
ADI for total residues of gamithromycin
is 10 micrograms per kilogram of body
weight per day.
(b) Tolerances. The tolerances for
gamithromycin (the marker residue) are:
(1) Cattle—(i) Liver (the target tissue):
500 parts per billion (ppb).
(ii) Muscle. 150 ppb.
(2) [Reserved]
(c) Related conditions of use. See
§ 522.1014 of this chapter.
Dated: September 13, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011–23874 Filed 9–16–11; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
13:21 Sep 16, 2011
Jkt 223001
57907
Food and Drug Administration
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
21 CFR Part 556
List of Subjects in 21 CFR Part 556
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2011–N–0003]
Tolerances for Residues of New
Animal Drugs in Food; Progesterone
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
Animal drugs, Foods.
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 part 556 is amended as follows:
ACTION:
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to update the
allowable incremental increase for
residues of progesterone in edible
tissues of cattle and sheep based on the
1994 revised daily consumption values.
This action is being taken to improve
the accuracy of the regulations.
DATES: This rule is effective September
19, 2011.
FOR FURTHER INFORMATION CONTACT:
Kevin Gaido, Center for Veterinary
Medicine (HFV–153), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8212, email: kevin.gaido@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
512(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(i)) (21
CFR 514.105(a)) directs FDA to establish
tolerances by regulation, as necessary,
when a new animal drug is approved for
use in food-producing animals.
Progesterone is approved for use in
subcutaneous implants used for
increased rate of weight gain in suckling
beef calves and steers (21 CFR 522.1940)
and in vaginal inserts used for
management of the estrous cycle in
female cattle and ewes (21 CFR
529.1940).
FDA has noticed the animal drug
tolerance regulations do not reflect
levels for progesterone using the daily
consumption values in the current
guidance document, ‘‘Guideline for
Establishing a Safe Concentration’’ (59
FR 37499, July 22, 1994). At this time,
FDA is amending 21 CFR 556.540 to
reflect the revised daily consumption
values as applied to edible tissues of
cattle. Sheep are considered a minor
species for human food safety
assessment, and the updated allowable
incremental increase limits for cattle
tissues based on the revised daily
consumption values are applicable to
sheep. This action is being taken to
improve the accuracy of the regulations.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
SUMMARY:
PO 00000
Frm 00011
Fmt 4700
Sfmt 4700
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
1. The authority citation for 21 CFR
part 556 continues to read as follows:
■
Authority: 21 U.S.C. 342, 360b, 371.
■
2. Revise § 556.540 to read as follows:
§ 556.540
Progesterone.
(a) [Reserved]
(b) Tolerances. Residues of
progesterone are not permitted in excess
of the following increments above the
concentrations of progesterone naturally
present in untreated animals:
(1) Cattle and sheep—(i) Muscle: 5
parts per billion (ppb).
(ii) Liver: 15 ppb.
(iii) Kidney: 30 ppb.
(iv) Fat: 30 ppb.
(2) [Reserved]
(c) Related conditions of use. See
§§ 522.1940 and 529.1940 of this
chapter.
Dated: September 13, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011–23867 Filed 9–16–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF THE TREASURY
Fiscal Service
31 CFR Part 240
RIN 1510–AB25
Indorsement and Payment of Checks
Drawn on the United States Treasury
Financial Management Service,
Fiscal Service, Treasury.
ACTION: Final rule.
AGENCY:
This final rule authorizes the
Department of the Treasury (Treasury),
Financial Management Service (FMS),
to direct Federal Reserve Banks to debit
a financial institution’s Master Account
for all check reclamations against the
financial institution that the financial
institution has not protested. Financial
SUMMARY:
E:\FR\FM\19SER1.SGM
19SER1
]]>Agencies
[Federal Register Volume 76, Number 181 (Monday, September 19, 2011)]
[Rules and Regulations]
[Pages 57906-57907]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23874]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 522 and 556
[Docket No. FDA-2011-N-0003]
New Animal Drugs; Gamithromycin
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 of an original new animal drug
application (NADA) filed by Merial, Ltd. The NADA provides for the
veterinary prescription use of gamithromycin injectable solution for
the management of bovine respiratory disease (BRD). FDA is also
amending the regulations to add the established tolerances for residues
of gamithromycin in edible tissues of cattle.
DATES: This rule is effective September 19, 2011.
FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail:
cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg.
500, Duluth, GA 30096-4640 filed NADA 141-328 that provides for the
veterinary prescription use of ZACTRAN (gamithromycin), an injectable
solution, in beef and non-lactating dairy cattle for the treatment of
BRD associated with Mannheimia haemolytica, Pasteurella multocida, and
Histophilus somni; and for the control of respiratory disease in beef
and non-lactating dairy cattle at high risk of developing BRD
associated with M. haemolytica and P. multocida. The application is
approved as of June 16, 2011, and the regulations are amended in 21 CFR
parts 522 and 556 to reflect the approval.
A summary of safety and effectiveness data and information
submitted to support approval of this application 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.
Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for
5 years of marketing exclusivity beginning on the date of approval.
The Agency has determined under 21 CFR 25.33 that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
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 522
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
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 522 and
556 are amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. Section 522.1014 is added to read as follows:
[[Page 57907]]
Sec. 522.1014 Gamithromycin.
(a) Specifications. Each milliliter (mL) of solution contains 150
milligrams (mg) gamithromycin.
(b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.292 of this chapter.
(d) Conditions of use--(1) Cattle--(i) Amount. Administer 6 mg/
kilogram of body weight (2 mL per 110 pounds) one time by subcutaneous
injection in the neck.
(ii) Indications for use. For the treatment of bovine respiratory
disease (BRD) associated with Mannheimia haemolytica, Pasteurella
multocida, and Histophilus somni in beef and non-lactating dairy
cattle; and for the control of respiratory disease in beef and non-
lactating dairy cattle at high risk of developing BRD associated with
M. haemolytica and P. multocida.
(iii) Limitations. Cattle intended for human consumption must not
be slaughtered within 35 days from the last treatment. Do not use in
female dairy cattle 20 months of age or older. A withdrawal period has
not been established for this product in preruminating calves. Do not
use in calves to be processed for veal. Federal law restricts this drug
to use by or on the order of a licensed veterinarian.
(2) [Reserved]
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.
0
4. Section 556.292 is added to read as follows:
Sec. 556.292 Gamithromycin.
(a) Acceptable Daily Intake (ADI). The ADI for total residues of
gamithromycin is 10 micrograms per kilogram of body weight per day.
(b) Tolerances. The tolerances for gamithromycin (the marker
residue) are:
(1) Cattle--(i) Liver (the target tissue): 500 parts per billion
(ppb).
(ii) Muscle. 150 ppb.
(2) [Reserved]
(c) Related conditions of use. See Sec. 522.1014 of this chapter.
Dated: September 13, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-23874 Filed 9-16-11; 8:45 am]
BILLING CODE 4160-01-P
