Implantation or Injectable Dosage Form New Animal Drugs; Tulathromycin, 39918-39919 [05-13586]
Download as PDF
<![CDATA[
39918
Federal Register / Vol. 70, No. 132 / Tuesday, July 12, 2005 / Rules and Regulations
V–537 [Revised]
From Palm Beach, FL; INT Palm Beach
356° and Vero Beach, FL, 143° radials; Vero
Beach; INT Vero Beach 318° and Orlando.
FL, 140° radials; INT Orlando 140° and
Melbourne, FL 298° radials; INT Melbourne
298° and Ocala, FL 145° radials; Ocala;
Gators, FL; Greenville, FL; Moultrie, GA; to
Macon, GA.
*
*
*
*
*
Issued in Washington, DC, on July 6, 2005.
Edith V. Parish,
Acting Manager, Airspace and Rules.
[FR Doc. 05–13682 Filed 7–11–05; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 522 and 556
Implantation or Injectable Dosage
Form New Animal Drugs;
Tulathromycin
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 a new animal drug
application (NADA) filed by Pfizer, Inc.
The NADA provides for the veterinary
prescription use of tulathromycin
solution in cattle and in swine, by
injection, for the management of
respiratory disease. FDA is also
amending the regulations to add the
acceptable daily intake for total residues
of tulathromycin and tolerances for
residues of tulathromycin in edible
tissues of cattle and swine.
DATES: This rule is effective July 12,
2005.
FOR FURTHER INFORMATION CONTACT:
Joan
C. Gotthardt, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.gov.
SUPPLEMENTARY INFORMATION: Pfizer,
Inc., 235 East 42d St., New York, NY
10017, filed NADA 141–244 for
DRAXXIN (tulathromycin) Injectable
Solution. The NADA provides for the
veterinary prescription use of
tulathromycin solution in cattle, by
subcutaneous injection, for the
treatment of bovine respiratory disease
(BRD) associated with Mannheimia
haemolytica, Pasteurella multocida, and
Histophilus somni (Haemophilus
somnus); for the control of respiratory
VerDate jul<14>2003
14:34 Jul 11, 2005
Jkt 205001
disease in cattle at high risk of
developing BRD associated with M.
haemolytica, P. multocida, and H.
somni; and in swine, by intramuscular
injection, for the treatment of swine
respiratory disease (SRD) associated
with Actinobacillus pleuropneumoniae,
P. multocida, Bordetella bronchiseptica,
and H. parasuis. The application is
approved as of May 24, 2005, and the
regulations are amended in part 522 (21
CFR part 522) by adding § 522.2630 and
in part 556 (21 CFR part 556) by adding
§ 556.745 to reflect the approval. The
basis of approval is discussed in the
freedom of information (FOI) summary.
In accordance with the FOI provisions
of 21 CFR part 20 and 21 CFR
514.11(e)(2)(ii), 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 May
24, 2005.
The agency has determined under 21
CFR 25.33(d)(5) that these actions are of
a type that do 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.
I 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:
I
PO 00000
Authority: 21 U.S.C. 360b.
Frm 00014
Fmt 4700
Sfmt 4700
2. Section 522.2630 is added to read as
follows:
I
§ 522.2630
Tulathromycin.
(a) Specifications. Each milliliter of
solution contains 100 milligrams (mg)
tulathromycin.
(b) Sponsor. See No. 000069 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 556.745
of this chapter.
(d) Conditions of use—(1) Beef and
nonlactating dairy cattle—(i) Amount.
2.5 mg per kilogram (/kg) body weight
as a single 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 (Haemophilus
somnus); for the control of respiratory
disease in 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 18 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) Swine—(i) Amount. 2.5 mg/kg
body weight as a single intramuscular
injection in the neck.
(ii) Indications for use. For the
treatment of swine respiratory disease
(SRD) associated with Actinobaccillus
pleuropneumoniae, P. multocida,
Bordetella bronchiseptica, and H.
parasuis.
(iii) Limitations. Swine intended for
human consumption must not be
slaughtered within 5 days from the last
treatment. Federal law restricts this drug
to use by or on the order of a licensed
veterinarian.
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:
I
Authority: 21 U.S.C. 342, 360b, 371.
4. Section 556.745 is added to read as
follows:
I
§ 556.745
Tulathromycin.
(a) Acceptable daily intake (ADI). The
ADI for total residues of tulathromycin
is 15 micrograms per kilogram of body
weight per day.
E:\FR\FM\12JYR1.SGM
12JYR1
Federal Register / Vol. 70, No. 132 / Tuesday, July 12, 2005 / Rules and Regulations
(b) Tolerances—(1) Cattle—(i) Liver
(the target tissue). The tolerance for CP–
60,300 (the marker residue) is 5.5 parts
per million (ppm).
(ii) [Reserved]
(2) Swine—(i) Kidney (the target
tissue). The tolerance for CP–60,300 (the
marker residue) is 15 ppm.
(ii) [Reserved]
(c) Related conditions of use. See
§ 522.2630 of this chapter.
Dated: June 20, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05–13586 Filed 7–11–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF STATE
22 CFR Part 126
[Public Notice 5130]
RIN 1400–ZA17
Amendments to the International
Traffic in Arms Regulations: Part 126
Department of State.
ACTION: Final rule.
AGENCY:
SUMMARY: The Department of State is
amending and/or clarifying the content
of the International Traffic in Arms
Regulations (ITAR). The affected part of
the ITAR is: Part 126—Policies and
Provisions. See Supplementary
Information for a description of the
changes and clarifications made.
EFFECTIVE DATE: July 12, 2005.
ADDRESSES: Interested parties are
invited to submit written comments to
the Department of State, Directorate of
Defense Trade Controls, Office of
Defense Trade Controls Policy, ATTN:
Regulatory Change, 12th Floor, SA–1,
Washington, DC 20522–0112. E-mail
comments may be sent to
DDTCResponseTeam@state.gov with an
appropriate subject line. Persons with
access to the Internet may also view this
notice by going to the regulations.gov
Web site at: https://www.regulations.gov.
Comments will be accepted at any time.
FOR FURTHER INFORMATION CONTACT: Mr.
Stephen Tomchik, Office of Defense
Trade Controls Policy, Department of
State, Telephone (202) 663–2799 or FAX
(202) 261–8199. ATTN: Regulatory
Change, USML Sections 126.5 and
126.15.
Two
changes are made to the International
Traffic in Arms Regulations (ITAR) Part
126—General Policies and Provisions.
The first change affects 22 CFR 126.5.
This section describes inter alia the
SUPPLEMENTARY INFORMATION:
VerDate jul<14>2003
14:34 Jul 11, 2005
Jkt 205001
modalities by which exporters, without
a license issued by the Directorate of
Defense Trade Controls (DDTC), may
conduct permanent and temporary
exports of defense articles to Canada,
and temporary imports from Canada.
These changes to 22 CFR 126.5 are
designed to clarify for exporters the
range of defense articles, related
technical data, and defense services that
will continue to require a license issued
by the Directorate of Defense Trade
Controls for export to or temporary
import from Canada.
The list of items excluded from the
provisions of Section 126.5 is outlined
in paragraph (b). That list is amended in
the following ways: the text of
126.5(b)(12) is amended to reflect
textual revisions to Category XIV of the
U.S. Munitions List regarding chemical
and biological agents. The body of
chemical agents encompassed by
126.5(b)(12) and previously controlled
in a single paragraph of the Category
now has been grouped by type and
distributed into several distinct
paragraphs. The text also clarifies but
does not change the scope of biological
agents controlled. Other changes are
made to reflect the redesignation of
paragraphs in the Category.
The second change is a result of
statutory direction. A new section of the
ITAR implements Section 1225 of
Public Law 108–375 regarding ‘‘Bilateral
Exchanges and Trade in Defense
Articles and Defense Services Between
the United States and the United
Kingdom and Australia.’’ This section,
to be designated 126.15, calls for the
expeditious processing of license
applications for the export of defense
articles and services to Australia or the
United Kingdom, consistent with
national security and the requirements
of the Arms Export Control Act (22
U.S.C. 2751 et seq.
Regulatory Analysis and Notices: This
amendment involves a foreign affairs
function of the United States and,
therefore, is not subject to the
procedures required by 5 U.S.C. 553 and
554. It is exempt from review under
executive Order 12866, but has been
reviewed internally by the Department
of State to ensure consistency with the
purposes thereof. This rule does not
require analysis under the Regulatory
Flexibility Act or the Unfunded
Mandates Reform Act. This amendment
has been found not to be a major rule
within the meaning of the Small
Business Regulatory Enforcement
Fairness Act of 1996. It will not have
substantial direct effects on the States,
the relationship between the national
Government and the States, or on the
distribution of power and
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
39919
responsibilities among the various
levels of government. Therefore, it is
determined that this rule does not have
sufficient federalism implications to
warrant application of the consultation
provisions of Executive Orders 12372
and 13132. 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.
I Accordingly, for the reasons set forth
above, Title 22, Chapter I, Subchapter M,
Part 126 is amended as follows:
PART 126—GENERAL POLICIES AND
PROVISIONS
1. The authority citation for Part 126
continues to read as follows:
I
Authority: Secs. 2, 38, 40, 42, and 71, Pub.
L. 90–629, 90 Stat. 744 (22 U.S.C. 2752, 2778,
2780, 2791, and 2797); E.O. 11958, 42 FR
4311; 3 CFR, 1977 Comp. p. 79; 22 U.S.C.
2651a; 22 U.S.C. 287c; E.O. 12918, 59 FR
28205, 3 CFR, 1994 Comp., p. 899; Sec. 1225,
Pub. L. 108–375.
2. Section 126.5 is amended by
revising paragraph (b)(12) to read as
follows:
I
§ 126.5
Canadian exemptions.
*
*
*
*
*
(b) * * *
(12) Chemical agents listed in
Category XIV (a), (d), and (e), biological
agents and biologically derived
substances in Category XIV (b), and
equipment listed in Category XIV (f) for
dissemination of the chemical agents
and biological agents listed in Category
XIV (a), (b), (d), and (e).
*
*
*
*
*
I 3. Section 126.15 is added to read as
follows:
§ 126.15 Expedited processing of license
applications for the export of defense
articles and defense services to Australia or
the United Kingdom.
(a) Any application submitted for
authorization of the export of defense
articles or services to Australia or the
United Kingdom will be expeditiously
processed by the Department of State, in
consultation with the Department of
Defense. Such license applications will
not be referred to any other Federal
department or agency, except when the
defense articles or defense services are
classified or exceptional circumstances
apply. (See section 1225, Pub. L. 108–
375).
(b) To be eligible for the expedited
processing in paragraph (a) of this
section, the destination of the
prospective export must be limited to
Australia or the United Kingdom. No
E:\FR\FM\12JYR1.SGM
12JYR1
]]>Agencies
[Federal Register Volume 70, Number 132 (Tuesday, July 12, 2005)]
[Rules and Regulations]
[Pages 39918-39919]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13586]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 522 and 556
Implantation or Injectable Dosage Form New Animal Drugs;
Tulathromycin
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 a new animal drug application
(NADA) filed by Pfizer, Inc. The NADA provides for the veterinary
prescription use of tulathromycin solution in cattle and in swine, by
injection, for the management of respiratory disease. FDA is also
amending the regulations to add the acceptable daily intake for total
residues of tulathromycin and tolerances for residues of tulathromycin
in edible tissues of cattle and swine.
DATES: This rule is effective July 12, 2005.
FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail:
joan.gotthardt@fda.gov.
SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY
10017, filed NADA 141-244 for DRAXXIN (tulathromycin) Injectable
Solution. The NADA provides for the veterinary prescription use of
tulathromycin solution in cattle, by subcutaneous injection, for the
treatment of bovine respiratory disease (BRD) associated with
Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni
(Haemophilus somnus); for the control of respiratory disease in cattle
at high risk of developing BRD associated with M. haemolytica, P.
multocida, and H. somni; and in swine, by intramuscular injection, for
the treatment of swine respiratory disease (SRD) associated with
Actinobacillus pleuropneumoniae, P. multocida, Bordetella
bronchiseptica, and H. parasuis. The application is approved as of May
24, 2005, and the regulations are amended in part 522 (21 CFR part 522)
by adding Sec. 522.2630 and in part 556 (21 CFR part 556) by adding
Sec. 556.745 to reflect the approval. The basis of approval is
discussed in the freedom of information (FOI) summary.
In accordance with the FOI provisions of 21 CFR part 20 and 21 CFR
514.11(e)(2)(ii), 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 May 24, 2005.
The agency has determined under 21 CFR 25.33(d)(5) that these
actions are of a type that do 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.
0
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 522.2630 is added to read as follows:
Sec. 522.2630 Tulathromycin.
(a) Specifications. Each milliliter of solution contains 100
milligrams (mg) tulathromycin.
(b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.745 of this chapter.
(d) Conditions of use--(1) Beef and nonlactating dairy cattle--(i)
Amount. 2.5 mg per kilogram (/kg) body weight as a single 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 (Haemophilus somnus); for the control
of respiratory disease in 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 18 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) Swine--(i) Amount. 2.5 mg/kg body weight as a single
intramuscular injection in the neck.
(ii) Indications for use. For the treatment of swine respiratory
disease (SRD) associated with Actinobaccillus pleuropneumoniae, P.
multocida, Bordetella bronchiseptica, and H. parasuis.
(iii) Limitations. Swine intended for human consumption must not be
slaughtered within 5 days from the last treatment. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
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 556.745 is added to read as follows:
Sec. 556.745 Tulathromycin.
(a) Acceptable daily intake (ADI). The ADI for total residues of
tulathromycin is 15 micrograms per kilogram of body weight per day.
[[Page 39919]]
(b) Tolerances--(1) Cattle--(i) Liver (the target tissue). The
tolerance for CP-60,300 (the marker residue) is 5.5 parts per million
(ppm).
(ii) [Reserved]
(2) Swine--(i) Kidney (the target tissue). The tolerance for CP-
60,300 (the marker residue) is 15 ppm.
(ii) [Reserved]
(c) Related conditions of use. See Sec. 522.2630 of this chapter.
Dated: June 20, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-13586 Filed 7-11-05; 8:45 am]
BILLING CODE 4160-01-S
