New Animal Drugs; Ceftiofur Crystalline Free Acid; Gamithromycin; Tylosin, 26161-26162 [2012-10632]
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Federal Register / Vol. 77, No. 86 / Thursday, May 3, 2012 / Rules and Regulations
navigation aid in the route description
correctly and the associated
aeronautical charts were published
accordingly. To overcome any confusion
or flight safety issues associated with
conflicting route description
information being published, the FAA is
amending the V–14 legal description to
reflect the airway aligned over the St.
Louis, MO, VOR/DME. Accordingly,
since this is an administrative
correction to update the V–14
description to be in concert with the
FAA’s aeronautical database and
charting, notice and public procedures
under Title 5 U.S.C. 553(b) are
unnecessary.
wreier-aviles on DSK7SPTVN1PROD with RULES
The Rule
The FAA amends Title 14 Code of
Federal Regulations (14 CFR) part 71 by
amending the legal description of VOR
Federal airway V–14 in the vicinity of
St. Louis, MO. Specifically, the FAA
amends V–14 to reflect the airway
aligned over the St. Louis, MO, VOR/
DME; thus, matching the information
currently contained in the FAA’s
aeronautical database and the charted
depiction of the airway.
VOR Federal airways are listed in
paragraph 6010 of FAA Order 7400.9V
dated August 9, 2011, and effective
September 15, 2011, which is
incorporated by reference in 14 CFR
71.1. The VOR Federal airway listed in
this document will be revised
subsequently in the Order.
The FAA has determined that this
regulation only involves an established
body of technical regulations for which
frequent and routine amendments are
necessary to keep them operationally
current. Therefore, this regulation: (1) Is
not a ‘‘significant regulatory action’’
under Executive Order 12866; (2) is not
a ‘‘significant rule’’ under Department of
Transportation (DOT) Regulatory
Policies and Procedures (44 FR 11034;
February 26, 1979); and (3) does not
warrant preparation of a regulatory
evaluation as the anticipated impact is
so minimal. Since this is a routine
matter that will only affect air traffic
procedures and air navigation, it is
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.
VerDate Mar<15>2010
15:19 May 02, 2012
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26161
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 an existing VOR Federal
airway within the NAS.
Albany 084° and Gardner, MA, 284° radials;
Gardner; to Norwich, CT.
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
ACTION:
Adoption of the Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 71 as follows:
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for part 71
continues to read as follows:
■
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order 7400.9V,
Airspace Designations and Reporting
Points, signed August 9, 2011, and
effective September 15, 2011, is
amended as follows:
■
Paragraph 6010 VOR Federal airways.
(a) Domestic VOR Federal airways.
*
*
*
*
*
V–14
From Chisum, NM; Lubbock, TX;
Childress, TX; Hobart, OK; Will Rogers, OK;
INT Will Rogers 052° and Tulsa, OK 246°
radials; Tulsa; Neosho, MO; Springfield, MO;
Vichy, MO; INT Vichy 067° and St. Louis,
MO, 225° radials; St. Louis; Vandalia, IL;
Terre Haute, IN; Brickyard, IN; Muncie, IN;
Flag City, OH; INT Flag City 079° and Dryer,
OH, 240° radials; Dryer; Jefferson, OH; Erie,
PA; Dunkirk, NY; Buffalo, NY; Geneseo, NY;
Georgetown, NY; INT Georgetown 093° and
Albany, NY, 270° radials; Albany; INT
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
*
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Issued in Washington, DC, April 24, 2012.
Paul Gallant,
Acting Manager, Airspace, Regulations and
ATC Procedures Group.
[FR Doc. 2012–10362 Filed 5–2–12; 8:45 am]
BILLING CODE 4910–13–P
Food and Drug Administration
21 CFR Parts 522 and 558
[Docket No. FDA–2012–N–0002]
New Animal Drugs; Ceftiofur
Crystalline Free Acid; Gamithromycin;
Tylosin
AGENCY:
Food and Drug Administration,
HHS.
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 February 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 May 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 is
adopting the 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.
In this document, FDA is amending
the animal drug regulations to reflect
the original and supplemental approval
actions during February 2012, as listed
in table 1 of this document. FDA is also
informing the public of the availability
of summaries of the basis of approval
(FOI Summaries) under the Freedom of
Information Act (FOIA) and of
environmental review documents
required under the National
Environmental Policy Act (NEPA),
where applicable.
SUMMARY:
E:\FR\FM\03MYR1.SGM
03MYR1
26162
Federal Register / Vol. 77, No. 86 / Thursday, May 3, 2012 / Rules and Regulations
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING FEBRUARY 2012
NADA/
ANADA
Sponsor
New animal drug product name
Action
21 CFR
Section
FOIA
Summary
NEPA
Review
141–328 ...
Merial Ltd., 3239 Satellite Blvd.,
Bldg. 500, Duluth, GA 30096–
4640.
ZACTRAN
(gamithromycin)
Injectable Solution.
Supplement adding treatment of bovine respiratory disease (BRD) associated with M. bovis.
522.1014
yes ...........
CE1
141–209 ...
Pharmacia & Upjohn Co., a Division
of Pfizer, Inc., 235 East 42d St.,
New York, NY 10017.
EXCEDE (ceftiofur crystalline free
acid) Sterile Suspension.
Supplement adding treatment of
acute bovine metritis in lactating
dairy cows; and modified injection
techniques.
522.313a
yes ...........
CE
200–484 ...
Huvepharma AD, 33 James Boucher
Blvd., Sophia 1407, Bulgaria.
TYLOVET 100 (tylosin phosphate)
Type A medicated Article.
Original approval as generic copy of
NADA 012–491.
558.625
yes ...........
CE
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 (EA)
or an environmental impact statement (EIS) because it is of a type that does not individually or cumulatively have a significant effect on the human environment.
The basis of approval of actions
requiring review of safety or
effectiveness data is discussed in an FOI
Summary that 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.
List of Subjects
21 CFR Part 522
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
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 558 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 522.313a, revise paragraphs
(e)(2)(i), (e)(2)(ii), and (e)(2)(iii) to read
as follows:
■
§ 522.313a
Ceftiofur crystalline free acid.
wreier-aviles on DSK7SPTVN1PROD with RULES
*
*
*
*
*
(e) * * *
(2) * * *
(i) Amount. For subcutaneous (SC)
injection in the posterior aspect of the
ear where it attaches to the head (base
of the ear) in lactating dairy cattle. For
SC injection in the middle third of the
posterior aspect of the ear or in the base
of the ear in beef and non-lactating dairy
cattle.
(A) Single-dose regimen: 6.6 mg
ceftiofur equivalents per kg of body
weight as a single injection.
(B) Two-dose regimen: 6.6 mg
ceftiofur equivalents per kg of body
VerDate Mar<15>2010
15:19 May 02, 2012
Jkt 226001
weight given as two injections in the
base of the ear approximately 72 hours
apart.
(ii) Indications for use—(A) Singledose regimen: For the treatment of
bovine respiratory disease (BRD,
shipping fever, pneumonia) associated
with Mannheimia haemolytica,
Pasteurella multocida, and Histophilus
somni in beef, non-lactating dairy, and
lactating dairy cattle. For the control of
respiratory disease in beef and nonlactating dairy cattle which are at high
risk of developing BRD associated with
M. haemolytica, P. multocida, and H.
somni. For the treatment of bovine foot
rot (interdigital necrobacillosis)
associated with Fusobacterium
necrophorum and Porphyromonas levii
in beef, non-lactating dairy, and
lactating dairy cattle.
(B) Two-dose regimen: For the
treatment of acute metritis (0-to 10-days
postpartum) associated with bacterial
organisms susceptible to ceftiofur in
lactating dairy cattle.
(iii) Limitations. Following label use
as either a single-dose or 2-dose
regimen, a 13-day pre-slaughter
withdrawal period is required after the
last treatment. A withdrawal period has
not been established in preruminating
calves. Do not use in calves to be
processed for veal.
*
*
*
*
*
associated with M. haemolytica and P.
multocida.
*
*
*
*
*
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
4. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
5. In § 558.625, add paragraph (b)(90)
to read as follows:
■
§ 558.625
Tylosin.
*
*
*
*
*
(b) * * *
(90) No. 016592: 100 grams per pound
for use as in paragraph (f) of this
section.
*
*
*
*
*
Dated: April 26, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012–10632 Filed 5–2–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 600, 610, and 680
[Docket No. FDA–2011–N–0080]
3. In 522.1014, revise paragraph
(d)(1)(ii) to read as follows:
Amendments to Sterility Test
Requirements for Biological Products
§ 522.1014
AGENCY:
■
Gamithromycin.
*
*
*
*
*
(d) * * *
(1) * * *
(ii) Indications for use. For the
treatment of bovine respiratory disease
(BRD) associated with Mannheimia
haemolytica, Pasteurella multocida,
Histophilus somni, and Mycoplasma
bovis 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
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
sterility test requirements for biological
products. This rule provides
manufacturers of biological products
greater flexibility, as appropriate, and
encourages use of the most appropriate
and state-of-the-art test methods for
assuring the safety of biological
SUMMARY:
E:\FR\FM\03MYR1.SGM
03MYR1
]]>Agencies
[Federal Register Volume 77, Number 86 (Thursday, May 3, 2012)]
[Rules and Regulations]
[Pages 26161-26162]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10632]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 522 and 558
[Docket No. FDA-2012-N-0002]
New Animal Drugs; Ceftiofur Crystalline Free Acid; Gamithromycin;
Tylosin
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 February 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 May 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 is
adopting the 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.
In this document, FDA is amending the animal drug regulations to
reflect the original and supplemental approval actions during February
2012, as listed in table 1 of this document. FDA is also informing the
public of the availability of summaries of the basis of approval (FOI
Summaries) under the Freedom of Information Act (FOIA) and of
environmental review documents required under the National
Environmental Policy Act (NEPA), where applicable.
[[Page 26162]]
Table 1--Original and Supplemental NADAs and ANADAs Approved During February 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
New animal drug product 21 CFR
NADA/ ANADA Sponsor name Action Section FOIA Summary NEPA Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-328......................... Merial Ltd., 3239 ZACTRAN (gamithromycin) Supplement adding 522.1014 yes............... CE\1\
Satellite Blvd., Bldg. Injectable Solution. treatment of bovine
500, Duluth, GA 30096- respiratory disease
4640. (BRD) associated with
M. bovis.
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-209......................... Pharmacia & Upjohn Co., EXCEDE (ceftiofur Supplement adding 522.313a yes............... CE
a Division of Pfizer, crystalline free acid) treatment of acute
Inc., 235 East 42d St., Sterile Suspension. bovine metritis in
New York, NY 10017. lactating dairy cows;
and modified injection
techniques.
--------------------------------------------------------------------------------------------------------------------------------------------------------
200-484......................... Huvepharma AD, 33 James TYLOVET 100 (tylosin Original approval as 558.625 yes............... CE
Boucher Blvd., Sophia phosphate) Type A generic copy of NADA
1407, Bulgaria. medicated Article. 012-491.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 (EA) or an environmental impact statement (EIS) because it is of a type that does not individually or cumulatively have a significant
effect on the human environment.
The basis of approval of actions requiring review of safety or
effectiveness data is discussed in an FOI Summary that 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.
List of Subjects
21 CFR Part 522
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
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
558 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 522.313a, revise paragraphs (e)(2)(i), (e)(2)(ii), and
(e)(2)(iii) to read as follows:
Sec. 522.313a Ceftiofur crystalline free acid.
* * * * *
(e) * * *
(2) * * *
(i) Amount. For subcutaneous (SC) injection in the posterior aspect
of the ear where it attaches to the head (base of the ear) in lactating
dairy cattle. For SC injection in the middle third of the posterior
aspect of the ear or in the base of the ear in beef and non-lactating
dairy cattle.
(A) Single-dose regimen: 6.6 mg ceftiofur equivalents per kg of
body weight as a single injection.
(B) Two-dose regimen: 6.6 mg ceftiofur equivalents per kg of body
weight given as two injections in the base of the ear approximately 72
hours apart.
(ii) Indications for use--(A) Single-dose regimen: For the
treatment of bovine respiratory disease (BRD, shipping fever,
pneumonia) associated with Mannheimia haemolytica, Pasteurella
multocida, and Histophilus somni in beef, non-lactating dairy, and
lactating dairy cattle. For the control of respiratory disease in beef
and non-lactating dairy cattle which are at high risk of developing BRD
associated with M. haemolytica, P. multocida, and H. somni. For the
treatment of bovine foot rot (interdigital necrobacillosis) associated
with Fusobacterium necrophorum and Porphyromonas levii in beef, non-
lactating dairy, and lactating dairy cattle.
(B) Two-dose regimen: For the treatment of acute metritis (0-to 10-
days postpartum) associated with bacterial organisms susceptible to
ceftiofur in lactating dairy cattle.
(iii) Limitations. Following label use as either a single-dose or
2-dose regimen, a 13-day pre-slaughter withdrawal period is required
after the last treatment. A withdrawal period has not been established
in preruminating calves. Do not use in calves to be processed for veal.
* * * * *
0
3. In 522.1014, revise paragraph (d)(1)(ii) to read as follows:
Sec. 522.1014 Gamithromycin.
* * * * *
(d) * * *
(1) * * *
(ii) Indications for use. For the treatment of bovine respiratory
disease (BRD) associated with Mannheimia haemolytica, Pasteurella
multocida, Histophilus somni, and Mycoplasma bovis 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.
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
4. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
5. In Sec. 558.625, add paragraph (b)(90) to read as follows:
Sec. 558.625 Tylosin.
* * * * *
(b) * * *
(90) No. 016592: 100 grams per pound for use as in paragraph (f) of
this section.
* * * * *
Dated: April 26, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-10632 Filed 5-2-12; 8:45 am]
BILLING CODE 4160-01-P
