Implantation or Injectable Dosage Form New Animal Drugs; Maropitant; Tildipirosin, 39390-39392 [2012-16203]
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39390
Federal Register / Vol. 77, No. 128 / Tuesday, July 3, 2012 / Rules and Regulations
action, contact Judi Citrenbaum, Office
of Aerospace Medicine, Federal
Aviation Administration, 800
Independence Avenue SW.,
Washington, DC 20591; telephone (202)
267–9689; email
Judi.M.Citrenbaum@faa.gov.
For legal questions concerning this
action, contact Sabrina Jawed, Office of
the Chief Counsel, Regulations Division,
Federal Aviation Administration, 800
Independence Avenue SW.,
Washington, DC 20591; telephone (202)
267–3073; email
Sabrina.Jawed@faa.gov.
SUPPLEMENTARY INFORMATION:
sroberts on DSK5SPTVN1PROD with NOTICES
Background
Since 2008, Title 14, Code of Federal
Regulations (14 CFR) § 67.401(j) has
required individuals granted the Special
Issuance of a Medical Certificate
(Authorization) to have their letter of
Authorization in their physical
possession or readily accessible in the
aircraft while exercising pilot privileges.
The FAA published a direct final rule
on March 22, 2012 (77 FR 16664) to
remove this provision for several
reasons. Namely, affected individuals
find the standard burdensome given that
other longstanding FAA operational
requirements already mandate that
pilots carry their medical certificate
when exercising pilot privileges. In
addition, the FAA is not aware of any
individuals affected by the standard
who have had to produce their letter of
Authorization for any civil aviation
authorities during the nearly 4-year
period the rule has been in effect. In this
regard, the FAA identified this
rulemaking action as burden-relieving
under Executive Order 13563 of January
18, 2011 entitled ‘‘Improving Regulation
and Regulatory Review.’’
Once this rule becomes effective,
§ 67.401(j) no longer will apply. This
means that the ‘‘Note’’ under the
regulatory reference to § 67.401(j) listed
under the ‘‘Conditions of Issue’’ on an
individual’s existing FAA medical
certificate no longer will be necessary.
This does not mean that the FAA needs
or intends to re-issue medical
certificates. It will be acceptable for the
FAA medical certificate to reference this
‘‘Note’’ until an individual’s medical
certificate is renewed. The FAA will
begin using medical certificates with
updated ‘‘Conditions of Issue’’ that do
not include reference to the removed
standard as soon as possible after July
20, 2012.
The FAA received nine supportive
comments from individuals and one
15:49 Jul 02, 2012
Conclusion
The FAA received no adverse
comments in response to the direct final
rule ‘‘Removal of the Part 67
Requirement for Individuals Granted the
Special Issuance of a Medical Certificate
to Carry Their Letter of Authorization
While Exercising Pilot Privileges’’. The
FAA has determined that no further
rulemaking action is necessary.
Therefore, the rule is adopted as
amendment 67–21 and becomes
effective on July 20, 2012.
Jkt 226001
SECURITIES AND EXCHANGE
COMMISSION
17 CFR Parts 229 and 240
[Release Nos. 33–9330; 34–67220; File No.
S7–13–11]
RIN 3235–AK95
Listing Standards for Compensation
Committees
Correction
In rule document 2012–15408,
appearing on pages 38422–38455, in the
issue of Wednesday, June 27, 2012,
make the following correction:
1. On page 38422, in column one,
under the heading DATES, Compliance
Dates, thirteenth line, ‘‘June 27, 2012’’
should read ‘‘June 27, 2013’’.
[FR Doc. C1–2012–15408 Filed 7–2–12; 8:45 am]
BILLING CODE 1505–01–D
How To Obtain Additional Information
A. Rulemaking Documents
An electronic copy of a rulemaking
document my be obtained by using the
Internet —
1. Search the Federal eRulemaking
Portal (https://www.regulations.gov);
2. Visit the FAA’s Regulations and
Policies Web page at https://
www.faa.gov/regulations_policies/ or
3. Access the Government Printing
Office’s Web page at https://
www.gpo.gov/fdsys.
Copies may also be obtained by
sending a request (identified by notice,
amendment, or docket number of this
rulemaking) to the Federal Aviation
Administration, Office of Rulemaking,
ARM–1, 800 Independence Avenue
SW., Washington, DC 20591, or by
calling (202) 267–9680.
B. Comments Submitted to the Docket
Comments received may be viewed by
going to https://www.regulations.gov and
following the online instructions to
search the docket number for this
action. Anyone is able to search the
electronic form of all comments
received into any of the FAA’s dockets
by the name of the individual
submitting the comment (or signing the
comment, if submitted on behalf of an
association, business, labor union, etc.).
Issued in Washington, DC on June 6, 2012.
Frederick E. Tilton,
Federal Air Surgeon.
[FR Doc. 2012–16317 Filed 7–2–12; 8:45 am]
Discussion of Comments
VerDate Mar<15>2010
supportive comment from the Air Line
Pilots Association International
regarding this action. All of the
commenters believe that this regulation
is unnecessary, and removing it would
relieve affected pilots of an undue
burden.
BILLING CODE 4910–13–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 522 and 556
[Docket No. FDA–2012–N–0002]
Implantation or Injectable Dosage
Form New Animal Drugs; Maropitant;
Tildipirosin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
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 May 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 July 3,
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,
email:george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA’s
Center for Veterinary Medicine (CVM) is
adopting use of a monthly Federal
Register document to codify approval
actions for NADAs and ANADAs. CVM
will no longer publish a separate rule
for each action. This approach will
allow a more efficient use of available
resources.
SUMMARY:
E:\FR\FM\03JYR1.SGM
03JYR1
Federal Register / Vol. 77, No. 128 / Tuesday, July 3, 2012 / Rules and Regulations
In this document, FDA is amending
the animal drug regulations to reflect
the original and supplemental approval
actions during May 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 (freedom of
information 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 CVM FOIA Electronic Reading
39391
Room at https://www.fda.gov/AboutFDA/
CentersOffices/OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm.
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.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MAY 2012
NADA/
ANADA
Sponsor
New animal drug
product name
141–334 .......
Intervet, Inc., 556 Morris Ave., Summit, NJ
07901.
ZUPREVO 18%
(tildipirosin)
Injectable Solution.
141–263 .......
Pfizer, Inc., 235 East
42d St., New York,
NY 10017.
CERENIA (maropitant
citrate) Injectable Solution.
21 CFR
Section
Action
Original approval for the treatment
of bovine respiratory disease
(BRD) 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.
Supplemental
approval
adding
treatment of vomiting in cats.
FOIA
Summary
NEPA
Review
522.2460
556.733
yes ...............
CE 1
522.1315
yes ...............
CE 1
1 The Agency has determined under 21 CFR 25.33 that this action is categorically excluded 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.
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. In § 522.1315, revise paragraph (c)
to read as follows:
■
§ 522.1315
Maropitant.
sroberts on DSK5SPTVN1PROD with NOTICES
*
*
*
*
*
(c) Conditions of use—(1) Dogs—(i)
Amount. Administer 1.0 mg per
kilogram (mg/kg) of body weight by
subcutaneous injection once daily for
up to 5 consecutive days.
(ii) Indications for use. For the
prevention and treatment of acute
vomiting.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
VerDate Mar<15>2010
15:49 Jul 02, 2012
Jkt 226001
(2) Cats—(i) Amount. Administer 1.0
mg/kg of body weight by subcutaneous
injection once daily for up to 5
consecutive days.
(ii) Indications for use. For the
treatment of vomiting.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 3. Section 522.2460 is added to read
as follows:
slaughtered within 21 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]
§ 522.2460
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
Tildipirosin.
(a) Specifications. Each milliliter of
solution contains:
(1) 180 milligrams (mg) tildipirosin.
(2) [Reserved]
(b) Sponsor. See No. 000061 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 556.733
of this chapter.
(d) Conditions of use—(1) Cattle—(i)
Amount. Administer 4 mg/kg of
bodyweight 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, P. multocida, and H.
somni.
(iii) Limitations. Cattle intended for
human consumption must not be
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Fmt 4700
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4. The authority citation for 21 CFR
part 556 continues to read as follows:
■
Authority: 21 U.S.C. 342, 360b, 371.
■
5. Add § 556.733 to read as follows:
§ 556.733
Tildipirosin.
(a) Acceptable Daily Intake (ADI). The
ADI for total residues of tildipirosin is
10 micrograms per kilogram of body
weight per day.
(b) Tolerances. The tolerances for
tildipirosin (the marker residue) are:
(1) Cattle—(i) Liver (the target tissue):
10 parts per million.
(ii) [Reserved]
(2) [Reserved]
(c) Related conditions of use. See
§ 522.2460 of this chapter.
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03JYR1
39392
Federal Register / Vol. 77, No. 128 / Tuesday, July 3, 2012 / Rules and Regulations
Dated: June 27, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
RIN 1400–AD23
continuing efforts against terrorism.
Defense assistance to the Yemeni
government will be critical to increasing
stability and security throughout the
country and countering this threat.
Therefore, § 126.1(u) is removed, and
the Department will review on a caseby-case basis all requests for licenses or
other approvals for exports or temporary
imports of defense articles and defense
services destined for or originating in
Yemen.
[Public Notice 7944]
Regulatory Analysis and Notices
Amendment to the International Traffic
in Arms Regulations: Yemen
Administrative Procedure Act
The Department of State is of the
opinion that controlling the import and
export of defense articles and services is
a foreign affairs function of the United
States Government and that rules
implementing this function are exempt
from sections 553 (rulemaking) and 554
(adjudications) of the Administrative
Procedure Act. Since the Department is
of the opinion that this rule is exempt
from 5 U.S.C. 553, it is the view of the
Department of State that the provisions
of § 553(d) do not apply to this
rulemaking. Therefore, this rule is
effective upon publication. The
Department also finds that, given the
national security issues surrounding
U.S. policy towards Yemen, notice and
public procedure on this rule would be
impracticable, unnecessary, or contrary
to the public interest; for the same
reason, the rule will be effective
immediately. See 5 U.S.C. 808(2).
[FR Doc. 2012–16203 Filed 7–2–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF STATE
22 CFR Part 126
Department of State.
ACTION: Final rule.
AGENCY:
The Department of State is
amending the International Traffic in
Arms Regulations (ITAR) to update the
policy toward Yemen. Licenses or other
approvals for exports or imports of
defense articles and defense services
destined for or originating in Yemen
will be reviewed, and may be issued, on
a case-by-case basis.
DATES: Effective Date: This rule is
effective July 3, 2012.
FOR FURTHER INFORMATION CONTACT: Ms.
Candace M. J. Goforth, Director, Office
of Defense Trade Controls Policy, U.S.
Department of State, telephone (202)
663–2792, or email
DDTCResponseTeam@state.gov. ATTN:
Regulatory Change, Part 126, Yemen.
SUPPLEMENTARY INFORMATION: The
Department of State published a notice
in the Federal Register on December 16,
1992, providing that the defense export
policy for Yemen included a
‘‘presumption of denial’’ for proposed
exports of lethal defense articles or
items supporting such articles. On
August 8, 2011, the Department
amended the ITAR to include Yemen in
§ 126.1, which describes prohibited
exports, imports, and sales to or from
certain countries. That policy allowed
for the export of non-lethal defense
articles and defense services and nonlethal, safety-of-use defense articles for
lethal end-items. License applications
for the export of lethal defense articles
and defense services were denied.
This rule removes the ITAR § 126.1
limitations on defense trade with
Yemen. Less restrictive defense trade
will further the national security and
foreign policy interests of the United
States. The Republic of Yemen has
taken important steps to stabilize the
country, including holding successful
presidential elections in February 2012.
Furthermore, the Republic of Yemen is
a critical partner in the United States’
sroberts on DSK5SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:49 Jul 02, 2012
Jkt 226001
Regulatory Flexibility Act
Since the Department is of the
opinion that this rule is exempt from the
rulemaking provisions of 5 U.S.C. 553,
it does not require analysis under the
Regulatory Flexibility Act.
Unfunded Mandates Act of 1995
This amendment does not involve a
mandate that will result in the
expenditure by state, local, and tribal
governments, in the aggregate, or by the
private sector, of $100 million or more
in any year and it will not significantly
or uniquely affect small governments.
Therefore, no actions were deemed
necessary under the provisions of the
Unfunded Mandates Reform Act of
1995.
Small Business Regulatory Enforcement
Fairness Act of 1996
This amendment has been found not
to be a major rule within the meaning
of the Small Business Regulatory
Enforcement Fairness Act of 1996.
Executive Orders 12372 and 13132
This amendment will not have
substantial direct effects on the States,
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Therefore, in
accordance with Executive Order 13132,
it is determined that this amendment
does not have sufficient federalism
implications to require consultations or
warrant the preparation of a federalism
summary impact statement. The
regulations implementing Executive
Order 12372 regarding
intergovernmental consultation on
Federal programs and activities do not
apply to this amendment.
Executive Orders 12866 and 13563
Executive Orders 13563 and 12866
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributed impacts, and equity).
Executive Order 13563 emphasizes the
importance of quantifying both costs
and benefits, of reducing costs, of
harmonizing rules, and of promoting
flexibility. This rule has been
designated a ‘‘significant regulatory
action,’’ although not economically
significant, under section 3(f) of
Executive Order 12866. Accordingly,
the rule has been reviewed by the Office
of Management and Budget (OMB).
Executive Order 12988
The Department of State has reviewed
the amendment in light of sections 3(a)
and 3(b)(2) of Executive Order 12988 to
eliminate ambiguity, minimize
litigation, establish clear legal
standards, and reduce burden.
Executive Order 13175
The Department has determined that
this rulemaking will not have tribal
implications, will not impose
substantial direct compliance costs on
Indian tribal governments, and will not
preempt tribal law. Accordingly,
Executive Order 13175 does not apply
to this rulemaking.
Paperwork Reduction Act
This rule does not impose any new
reporting or recordkeeping requirements
subject to the Paperwork Reduction Act,
44 U.S.C. chapter 35.
List of Subjects in 22 CFR Part 126
Arms and munitions, Exports.
Accordingly, for the reasons set forth
above, Title 22, Chapter I, Subchapter
M, part 126 is amended as follows:
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]]>Agencies
[Federal Register Volume 77, Number 128 (Tuesday, July 3, 2012)]
[Rules and Regulations]
[Pages 39390-39392]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-16203]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 522 and 556
[Docket No. FDA-2012-N-0002]
Implantation or Injectable Dosage Form New Animal Drugs;
Maropitant; Tildipirosin
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 May 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 July 3, 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,
email:george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA's Center for Veterinary Medicine (CVM)
is adopting use of a monthly Federal Register document to codify
approval actions for NADAs and ANADAs. CVM will no longer publish a
separate rule for each action. This approach will allow a more
efficient use of available resources.
[[Page 39391]]
In this document, FDA is amending the animal drug regulations to
reflect the original and supplemental approval actions during May 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 (freedom of information
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 CVM FOIA
Electronic Reading Room at https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.
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.
Table 1--Original and Supplemental NADAs and ANADAs Approved During May 2012
----------------------------------------------------------------------------------------------------------------
New animal drug 21 CFR NEPA
NADA/ANADA Sponsor product name Action Section FOIA Summary Review
----------------------------------------------------------------------------------------------------------------
141-334......... Intervet, Inc., ZUPREVO 18% Original 522.2460 yes............. CE \1\
556 Morris (tildipirosin) approval for 556.733
Ave., Summit, Injectable the treatment
NJ 07901. Solution. of bovine
respiratory
disease (BRD)
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.
141-263......... Pfizer, Inc., CERENIA Supplemental 522.1315 yes............. CE \1\
235 East 42d (maropitant approval
St., New York, citrate) adding
NY 10017. Injectable treatment of
Solution. vomiting in
cats.
----------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded 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.
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. In Sec. 522.1315, revise paragraph (c) to read as follows:
Sec. 522.1315 Maropitant.
* * * * *
(c) Conditions of use--(1) Dogs--(i) Amount. Administer 1.0 mg per
kilogram (mg/kg) of body weight by subcutaneous injection once daily
for up to 5 consecutive days.
(ii) Indications for use. For the prevention and treatment of acute
vomiting.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Cats--(i) Amount. Administer 1.0 mg/kg of body weight by
subcutaneous injection once daily for up to 5 consecutive days.
(ii) Indications for use. For the treatment of vomiting.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
3. Section 522.2460 is added to read as follows:
Sec. 522.2460 Tildipirosin.
(a) Specifications. Each milliliter of solution contains:
(1) 180 milligrams (mg) tildipirosin.
(2) [Reserved]
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.733 of this chapter.
(d) Conditions of use--(1) Cattle--(i) Amount. Administer 4 mg/kg
of bodyweight 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, P. multocida, and H. somni.
(iii) Limitations. Cattle intended for human consumption must not
be slaughtered within 21 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
4. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
5. Add Sec. 556.733 to read as follows:
Sec. 556.733 Tildipirosin.
(a) Acceptable Daily Intake (ADI). The ADI for total residues of
tildipirosin is 10 micrograms per kilogram of body weight per day.
(b) Tolerances. The tolerances for tildipirosin (the marker
residue) are:
(1) Cattle--(i) Liver (the target tissue): 10 parts per million.
(ii) [Reserved]
(2) [Reserved]
(c) Related conditions of use. See Sec. 522.2460 of this chapter.
[[Page 39392]]
Dated: June 27, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-16203 Filed 7-2-12; 8:45 am]
BILLING CODE 4160-01-P
