New Animal Drugs; Enrofloxacin; Tilmicosin; Tylosin, 19986-19987 [2013-07571]
Download as PDF
<![CDATA[
19986
Federal Register / Vol. 78, No. 64 / Wednesday, April 3, 2013 / Rules and Regulations
certified that this rule, when
promulgated, will not have a significant
economic impact on a substantial
number of small entities under the
criteria of the Regulatory Flexibility Act.
The FAA’s authority to issue rules
regarding aviation safety is found in
Title 49 of the United States Code.
Subtitle I, Section 106 describes the
authority of the FAA Administrator.
Subtitle VII, Aviation Programs,
describes in more detail the scope of the
agency’s authority.
This rulemaking is promulgated
under the authority described in
Subtitle VII, Part A, Subpart I, Section
40103. Under that section, the FAA is
charged with prescribing regulations to
assign the use of the airspace necessary
to ensure the safety of aircraft and the
efficient use of airspace. This regulation
is within the scope of that authority as
it amends existing VOR Federal airways
in the NAS.
Environmental Review
The FAA has determined that this
action qualifies for categorical exclusion
under the National Environmental
Policy Act in accordance with 311a,
FAA Order 1050.1E, ‘‘Environmental
Impacts: Policies and Procedures.’’ This
airspace action is not expected to cause
any potentially significant
environmental impacts, and no
extraordinary circumstances exist that
warrant preparation of an
environmental assessment.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
Adoption of the Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 71 as follows:
Paragraph 6010
VOR Federal airways.
*
*
*
*
*
V–68
From Montrose, CO; Cones, CO; Dove
Creek, CO; Cortez, CO; Rattlesnake, NM; INT
Rattlesnake 128° and Albuquerque, NM, 345°
radials; Albuquerque; INT Albuquerque 120°
and Corona, NM, 311° radials; Corona; 41
miles 85 MSL, Chisum, NM; Hobbs, NM;
Midland, TX; San Angelo, TX; Junction, TX;
Center Point, TX; San Antonio, TX; INT San
Antonio 064° and Industry, TX, 267° radials;
Industry; INT Industry 101° and Hobby, TX,
289° radials; to Hobby.
*
*
*
*
*
V–76
From Lubbock, TX; INT Lubbock 188° and
Big Spring, TX, 286° radials; Big Spring; San
Angelo, TX; Llano, TX; Centex, TX; Industry,
TX; INT Industry 101° and Hobby, TX, 289°
radials; to Hobby.
*
*
*
*
*
V–194
From Cedar Creek, TX; College Station, TX;
INT College Station 151° and Hobby, TX,
289° radials; Hobby; Sabine Pass, TX;
Lafayette, LA; Baton Rouge, LA; McComb,
MS; INT McComb 055° and Meridian, MS;
221° radials; Meridian. From Liberty, NC;
Raleigh-Durham, NC; Tar River, NC; Cofield,
NC; to INT Cofield 077° and Norfolk, VA,
209° radials.
*
*
*
*
*
V–548
From Hobby, TX; INT Hobby 289° and
College Station, TX, 151° radials; College
Station; INT College Station 307° and Waco,
TX, 173° radials; to Waco.
Issued in Washington, DC, March 26, 2013.
Gary A. Norek,
Manager, Airspace Policy and ATC
Procedures Group.
[FR Doc. 2013–07472 Filed 4–2–13; 8:45 am]
BILLING CODE 4910–13–P
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
1. The authority citation for part 71
continues to read as follows:
21 CFR Parts 510, 522, and 558
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
[Docket No. FDA–2013–N–0002]
■
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order 7400.9W,
Airspace Designations and Reporting
Points, signed August 8, 2012, and
effective September 15, 2012, is
amended as follows:
wreier-aviles on DSK5TPTVN1PROD with RULES
■
VerDate Mar<15>2010
14:47 Apr 02, 2013
Jkt 229001
Food and Drug Administration
New Animal Drugs; Enrofloxacin;
Tilmicosin; Tylosin
AGENCY:
Food and Drug Administration,
HHS.
Final rule, technical
amendment.
ACTION:
The Food and Drug
Administration (FDA) is amending the
SUMMARY:
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
animal drug regulations to reflect
approval actions for new animal drug
applications and abbreviated new
animal drug applications during
February 2013. FDA is also informing
the public of the availability of
summaries the basis of approval and of
environmental review documents,
where applicable.
DATES:
This rule is effective April 3,
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,
george.haibel@fda.hhs.gov.
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 February
2013, 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
(CVM) FOIA Electronic Reading Room:
https://www.fda.gov/AboutFDA/
CentersOffices/OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm.
SUPPLEMENTARY INFORMATION:
In addition, the animal drug
regulations are being amended at 21
CFR 510.600 to correct the spelling of a
street name in the sponsor’s address,
and at 21 CFR 558.618 to clarify the
dosage of tilmicosin phosphate in
medicated feeds for beef and nonlactating dairy cattle.
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.
E:\FR\FM\03APR1.SGM
03APR1
Federal Register / Vol. 78, No. 64 / Wednesday, April 3, 2013 / Rules and Regulations
19987
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING FEBRUARY 2013
NADA/
ANADA
200–509
200–531
New animal drug product
name
Action
Norbrook Laboratories, Ltd.,
Station Works, Newry BT35
6JP, Northern Ireland.
Huvepharma AD, 5th Floor, 3A
Nikolay Haytov Str., 1113
Sophia, Bulgaria.
Huvepharma AD, 5th Floor, 3A
Nikolay Haytov Str., 1113
Sophia, Bulgaria.
200–495
21 CFR
section
FOIA
Summary
Sponsor
NEPA
Review
ENROFLOX 100 (enrofloxacin)
Injectable Solution.
Original approval as a generic
copy of NADA 141–068.
522.812
yes .......
CE 1
TILMOVET 90 (tilmicosin
phosphate) Type A medicated article.
TYLOVET 100 (tylosin phosphate) and RUMENSIN
(monensin) Type A medicated articles.
Original approval as a generic
copy of NADA 141–064.
558.618
yes .......
CE 1
Original approval as a generic
copy of NADA 104–646.
558.355
yes .......
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.
List of Subjects
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Part 522
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feed.
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 510, 522, and 558 are
amended as follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
§ 510.600
[Amended]
2. In § 510.600, in the table in
paragraph (c)(1), in the entry for
‘‘Huvepharma AD’’, remove ‘‘Haitov’’
and in its place add ‘‘Haytov’’; and in
the table in paragraph (c)(2), in the entry
for ‘‘016592’’, remove ‘‘Haitov’’ and in
its place add ‘‘Haytov’’.
■
(b) Sponsors. See sponsor numbers in
§ 510.600(c) of this chapter:
(1) No. 000859 for use of products
described in paragraph (a) as in
paragraph (e) of this section; and
(2) No. 055529 for use of product
described in paragraph (a)(2) as in
paragraphs (e)(2)(i)(B), (e)(2)(ii)(B),
(e)(2)(iii), (e)(3)(i), and (e)(3)(iii) of this
section.
*
*
*
*
*
(e) * * *
(2) Cattle. Use the product described
in paragraph (a)(2) of this section as
follows:
*
*
*
*
*
(3) * * *
(ii) Indications for use—(A) For the
treatment and control of swine
respiratory disease (SRD) associated
with Actinobacillus pleuropneumoniae,
Pasteurella multocida, Haemophilus
parasuis, Streptococcus suis, Bordetella
bronchiseptica, and Mycoplasma
hyopneumoniae.
(B) For the treatment and control of
swine respiratory disease (SRD)
associated with Actinobacillus
pleuropneumoniae, Pasteurella
multocida, Haemophilus parasuis, and
Streptococcus suis.
*
*
*
*
*
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
5. The authority citation for 21 CFR
part 558 continues to read as follows:
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, 371.
wreier-aviles on DSK5TPTVN1PROD with RULES
■
Authority: 21 U.S.C. 360b.
4. In § 522.812, revise paragraphs (b)
and (e)(3)(ii); and add introductory text
to paragraph (e)(2) to read as follows:
6. In § 558.355, remove and reserve
paragraph (f)(3)(ix); and in paragraphs
(f)(3)(ii)(b) and (f)(3)(xii)(b), add a new
last sentence to read as follows:
(b) * * * Tylosin provided by Nos.
000986 and 016592 in § 510.600(c) of
this chapter.
*
*
*
*
*
(xii) * * *
(b) * * * Tylosin provided by Nos.
000986 and 016592 in § 510.600(c) of
this chapter.
*
*
*
*
*
§ 558.618
[Amended]
7. Amend § 558.618 as follows:
■ a. In paragraph (b), remove ‘‘No.
000986’’ and in its place add ‘‘Nos.
000986 and 016592’’;
■ b. In the table in paragraph (e)(1)(i), in
the ‘‘Sponsor’’ column, add ‘‘, 016592’’
after ‘‘000986’’;
■ c. In the table in paragraph (e)(1)(ii),
in the ‘‘Sponsor’’ column, remove
‘‘000986’’;
■ d. In the table in paragraph (e)(2)(i), in
the ‘‘Limitations’’ column, in the first
sentence, remove ‘‘12.5 milligrams/
kilogram/head/day’’ and in its place add
‘‘12.5 mg tilmicosin/kg of bodyweight/
day’’; and
■ e. In the table in paragraphs (e)(2)(ii)
and (e)(2)(iii), in the ‘‘Limitations’’
column, in the first sentence, remove
‘‘12.5 milligrams tilmicosin/kilogram/
head/day’’ and in its place add ‘‘12.5 mg
tilmicosin/kg of bodyweight/day’’.
■
Dated: March 26, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013–07571 Filed 4–2–13; 8:45 am]
BILLING CODE 4160–01–P
■
§ 522.812
*
*
Enrofloxacin.
*
§ 558.355
*
VerDate Mar<15>2010
*
*
14:47 Apr 02, 2013
Jkt 229001
PO 00000
Monensin.
*
*
(f) * * *
(3) * * *
(ii) * * *
Frm 00007
*
Fmt 4700
*
Sfmt 9990
E:\FR\FM\03APR1.SGM
03APR1
]]>Agencies
[Federal Register Volume 78, Number 64 (Wednesday, April 3, 2013)]
[Rules and Regulations]
[Pages 19986-19987]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07571]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 522, and 558
[Docket No. FDA-2013-N-0002]
New Animal Drugs; Enrofloxacin; Tilmicosin; Tylosin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule, technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval actions for new animal drug
applications and abbreviated new animal drug applications during
February 2013. FDA is also informing the public of the availability of
summaries the basis of approval and of environmental review documents,
where applicable.
DATES: This rule is effective April 3, 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,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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 February
2013, 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 (CVM) FOIA
Electronic Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.
In addition, the animal drug regulations are being amended at 21
CFR 510.600 to correct the spelling of a street name in the sponsor's
address, and at 21 CFR 558.618 to clarify the dosage of tilmicosin
phosphate in medicated feeds for beef and non-lactating dairy cattle.
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.
[[Page 19987]]
Table 1--Original and Supplemental NADAs and ANADAs Approved During February 2013
----------------------------------------------------------------------------------------------------------------
New animal drug 21 CFR FOIA NEPA
NADA/ANADA Sponsor product name Action section Summary Review
----------------------------------------------------------------------------------------------------------------
200-495........... Norbrook ENROFLOX 100 Original approval 522.812 yes......... CE \1\
Laboratories, (enrofloxacin) as a generic
Ltd., Station Injectable copy of NADA 141-
Works, Newry Solution. 068.
BT35 6JP,
Northern Ireland.
200-509........... Huvepharma AD, TILMOVET 90 Original approval 558.618 yes......... CE \1\
5th Floor, 3A (tilmicosin as a generic
Nikolay Haytov phosphate) Type copy of NADA 141-
Str., 1113 A medicated 064.
Sophia, Bulgaria. article.
200-531........... Huvepharma AD, TYLOVET 100 Original approval 558.355 yes......... CE \1\
5th Floor, 3A (tylosin as a generic
Nikolay Haytov phosphate) and copy of NADA 104-
Str., 1113 RUMENSIN 646.
Sophia, Bulgaria. (monensin) Type
A medicated
articles.
----------------------------------------------------------------------------------------------------------------
\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.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 522
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feed.
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 510,
522, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
Sec. 510.600 [Amended]
0
2. In Sec. 510.600, in the table in paragraph (c)(1), in the entry for
``Huvepharma AD'', remove ``Haitov'' and in its place add ``Haytov'';
and in the table in paragraph (c)(2), in the entry for ``016592'',
remove ``Haitov'' and in its place add ``Haytov''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 522.812, revise paragraphs (b) and (e)(3)(ii); and add
introductory text to paragraph (e)(2) to read as follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter:
(1) No. 000859 for use of products described in paragraph (a) as in
paragraph (e) of this section; and
(2) No. 055529 for use of product described in paragraph (a)(2) as
in paragraphs (e)(2)(i)(B), (e)(2)(ii)(B), (e)(2)(iii), (e)(3)(i), and
(e)(3)(iii) of this section.
* * * * *
(e) * * *
(2) Cattle. Use the product described in paragraph (a)(2) of this
section as follows:
* * * * *
(3) * * *
(ii) Indications for use--(A) For the treatment and control of
swine respiratory disease (SRD) associated with Actinobacillus
pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis,
Streptococcus suis, Bordetella bronchiseptica, and Mycoplasma
hyopneumoniae.
(B) For the treatment and control of swine respiratory disease
(SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella
multocida, Haemophilus parasuis, and Streptococcus suis.
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
5. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
6. In Sec. 558.355, remove and reserve paragraph (f)(3)(ix); and in
paragraphs (f)(3)(ii)(b) and (f)(3)(xii)(b), add a new last sentence to
read as follows:
Sec. 558.355 Monensin.
* * * * *
(f) * * *
(3) * * *
(ii) * * *
(b) * * * Tylosin provided by Nos. 000986 and 016592 in Sec.
510.600(c) of this chapter.
* * * * *
(xii) * * *
(b) * * * Tylosin provided by Nos. 000986 and 016592 in Sec.
510.600(c) of this chapter.
* * * * *
Sec. 558.618 [Amended]
0
7. Amend Sec. 558.618 as follows:
0
a. In paragraph (b), remove ``No. 000986'' and in its place add ``Nos.
000986 and 016592'';
0
b. In the table in paragraph (e)(1)(i), in the ``Sponsor'' column, add
``, 016592'' after ``000986'';
0
c. In the table in paragraph (e)(1)(ii), in the ``Sponsor'' column,
remove ``000986'';
0
d. In the table in paragraph (e)(2)(i), in the ``Limitations'' column,
in the first sentence, remove ``12.5 milligrams/kilogram/head/day'' and
in its place add ``12.5 mg tilmicosin/kg of bodyweight/day''; and
0
e. In the table in paragraphs (e)(2)(ii) and (e)(2)(iii), in the
``Limitations'' column, in the first sentence, remove ``12.5 milligrams
tilmicosin/kilogram/head/day'' and in its place add ``12.5 mg
tilmicosin/kg of bodyweight/day''.
Dated: March 26, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-07571 Filed 4-2-13; 8:45 am]
BILLING CODE 4160-01-P
