New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor, 64114-64117 [2014-25588]
Download as PDF
<![CDATA[
64114
Federal Register / Vol. 79, No. 208 / Tuesday, October 28, 2014 / Rules and Regulations
funded. The Council may thereafter
revise this list.
[FR Doc. 2014–25610 Filed 10–24–14; 4:15 pm]
BILLING CODE 3510–22–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and
556
[Docket No. FDA–2014–N–0002]
New Animal Drugs; Alfaxalone;
Dinoprost; Ivermectin and Clorsulon;
Nitrofurazone; Trenbolone and
Estradiol Benzoate; Trimethoprim and
Sulfadiazine; Tylosin; Change of
Sponsor
AGENCY:
Food and Drug Administration,
HHS.
Final rule, technical
amendment.
ACTION:
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 August 2014. FDA is
also informing the public of the
availability of summaries of the basis of
approval and of environmental review
documents, where applicable. The
animal drug regulations are also being
amended to reflect a change of
sponsorship of two NADAs and one
SUMMARY:
ANADA, and to reflect a revised food
safety warning.
DATES: This rule is effective October 28,
2014.
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 NADAs and
ANADAs during August 2014, 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 CVM FOIA Electronic
Reading Room: https://www.fda.gov/
AboutFDA/CentersOffices/
OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm. Marketing exclusivity and
patent information may be accessed in
FDA’s publication, Approved Animal
Drug Products Online (Green Book) at:
https://www.fda.gov/AnimalVeterinary/
Products/
ApprovedAnimalDrugProducts/
default.htm.
In addition, Macleod
Pharmaceuticals, Inc., 2600 Canton Ct.,
Fort Collins, CO 80525 has transferred
ownership of, and all rights and interest
in ANADA 200–033 for UNIPRIM
(trimethoprim and sulfadiazine) Powder
to Neogen Corp. (Neogen), 944 Nandino
Blvd., Lexington, KY 40511. In 2004,
Hess & Clark, Inc., transferred
ownership of, and all rights and interest
in NADA 011–154 for NFZ Puffer
(nitrofurazone soluble powder) and
NADA 140–851 for NFZ Wound
Dressing (nitrofurazone ointment) to
Neogen. At this time, the regulations are
being amended to reflect these transfers.
Following these changes of
sponsorship, Macleod Pharmaceuticals,
Inc., and Hess & Clark, Inc., will no
longer be the sponsor of an approved
application. Accordingly, 21 CFR
510.600(c) is being amended to remove
the entries for these firms.
Also, the animal drug regulations are
being amended in 21 CFR 522.690 to
revise a human food safety warning for
dinoprost tromethamine injectable
solution. This amendment is being
made 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
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 AUGUST 2014
Sponsor
140–833 ......
Merial Ltd., 3239 Satellite Blvd., Bldg. 500,
Duluth, GA 30096–
4640.
IVOMEC Plus
(ivermectin and
clorsulon) Injection
for Cattle.
141–043 ......
Zoetis Inc., 333 Portage
St., Kalamazoo, MI
49007.
SYNOVEX CHOICE
(trenbolone and estradiol implant).
141–342 ......
asabaliauskas on DSK5VPTVN1PROD with RULES
NADA/
ANADA
Jurox Pty. Ltd., 85 Gardiner Rd., Rutherford,
NSW 2320, Australia.
ALFAXAN (alfaxalone)
Injectable Anesthetic
for Dogs and Cats.
VerDate Sep<11>2014
16:44 Oct 27, 2014
New animal drug
product name
Jkt 235001
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Frm 00058
Action
21 CFR
Sections
FOIA
Summary
Supplemental approval
reducing the
preslaughter withdrawal period from 49
days to 21 days.
Supplemental approval
for increased rate of
weight gain and improved feed efficiency
in heifers fed in confinement for slaughter.
Supplemental approval
adding a label statement that alfaxalone
is a Class IV controlled substance.
522.1193 ........
556.344 ..........
yes .................
CE.1 2
522.2478 ........
yes .................
EA/FONSI.3
522.52 ............
no ...................
CE.1 4
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NEPA Review
64115
Federal Register / Vol. 79, No. 208 / Tuesday, October 28, 2014 / Rules and Regulations
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING AUGUST 2014—Continued
NADA/
ANADA
Sponsor
New animal drug
product name
Action
21 CFR
Sections
FOIA
Summary
141–348 ......
Zoetis Inc., 333 Portage
St., Kalamazoo, MI
49007.
SYNOVEX ONE FEEDLOT (trenbolone and
estradiol extended release implant).
SYNOVEX ONE
GRASS (trenbolone
and estradiol extended release implant).
522.2478 ........
yes .................
EA/FONSI.1 3
200–455 5 ....
Cross Vetpharm Group
Ltd. Broomhill Rd.,
Tallaght,.
Dublin 24, Ireland .........
TYLOMED–WS (tylosin
tartrate) Soluble Powder.
Original approval for increased rate of
weight gain and improved feed efficiency
for up to 200 days in
steers and heifers fed
in confinement for
slaughter.
Original approval for increased rate of
weight gain for up to
200 days in pasture
steers and heifers
(slaughter, stocker,
and feeder).
Supplemental approval
of a change to veterinary prescription (Rx)
marketing status to
conform with reference (pioneer)
product.
520.2640 ........
no ...................
CE.1 6
NEPA Review
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.
2 CE granted under 21 CFR 25.33(a).
3 The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a
finding of no significant impact (FONSI).
4 CE granted under 21 CFR 25.33(d)(1).
5 This application was listed as being affected by guidance for industry (GFI) #213, ‘‘New Animal Drugs and New Animal Drug Combination
Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209’’, December 2013.
6 CE granted under 21 CFR 25.33(a)(1).
List of Subjects
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Parts 520, 522, and 524
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 510, 520, 522, 524, and 556
are amended as follows:
PART 510—NEW ANIMAL DRUGS
‘‘Macleod Pharmaceuticals, Inc.’’ and
‘‘Hess & Clark, Inc.’’ and alphabetically
add an entry for ‘‘Neogen Corp.’’; and in
the table in paragraph (c)(2), remove the
entries for ‘‘058711’’ and ‘‘050749’’ and
numerically add an entry for ‘‘059051’’
to read as follows:
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 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
■
2. In § 510.600, in the table in
paragraph (c)(1), remove the entries for
■
*
*
(c) * * *
(1) * * *
*
*
Drug labeler
code
Firm name and address
*
*
*
*
*
*
Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511 ..................................................................................................................
asabaliauskas on DSK5VPTVN1PROD with RULES
*
*
*
*
*
*
059051
*
*
*
*
(2) * * *
Drug labeler
code
*
059051
VerDate Sep<11>2014
Firm name and address
*
*
*
Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511
16:44 Oct 27, 2014
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PO 00000
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*
Sfmt 4700
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Federal Register / Vol. 79, No. 208 / Tuesday, October 28, 2014 / Rules and Regulations
Drug labeler
code
Firm name and address
*
*
*
§ 522.1193
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for 21 CFR
part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
[Amended]
4. In paragraph (b) of § 520.2613,
remove ‘‘058711’’ and in its place add
‘‘059051’’.
■ 5. In § 520.2640, revise paragraphs (b),
(d), and (e)(2)(ii) to read as follows:
■
§ 520.2640
Tylosin.
*
*
*
*
*
(b) Sponsors—(1) No. 000986 for use
as in paragraph (e) of this section.
(2) Nos. 016592 and 061623 for use as
in paragraphs (e)(1)(i)(A), (e)(1)(ii),
(e)(2), (e)(3), and (e)(4) of this section.
*
*
*
*
*
(d) Special considerations. Federal
law restricts this drug to use by or on
the order of a licensed veterinarian.
(e) * * *
(2) * * *
(ii) Indications for use. For the
reduction in severity of effects of
infectious sinusitis associated with
Mycoplasma gallisepticum.
*
*
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
6. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
7. In § 522.52, in paragraph (c)(3), add
a second sentence to read as follows:
■
§ 522.52
Alfaxalone.
*
*
*
*
*
(c) * * *
(3) * * * Alfaxalone is a Class IV
controlled substance.
8. In § 522.690, revise paragraph
(d)(1)(iii) to read as follows:
■
asabaliauskas on DSK5VPTVN1PROD with RULES
§ 522.690
Dinoprost.
*
*
*
*
*
(d) * * *
(1) * * *
(iii) Limitations. Do not use in horses
intended for human consumption.
*
*
*
*
*
■ 9. In § 522.1193, revise paragraph
(e)(3) to read as follows:
VerDate Sep<11>2014
16:44 Oct 27, 2014
Jkt 235001
*
Ivermectin and clorsulon.
*
■
§ 520.2613
*
*
*
*
*
(e) * * *
(3) Limitations. For No. 050604: Do
not treat cattle within 21 days of
slaughter. For Nos. 055529 and 058005:
Do not treat cattle within 49 days of
slaughter. Because a withdrawal time in
milk has not been established, do not
use in female dairy cattle of breeding
age. A withdrawal period has not been
established for preruminating calves. Do
not use in calves to be processed for
veal.
■ 10. In § 522.2478, revise paragraphs
(a), (d)(1)(i) introductory text, (d)(1)(ii)
introductory text, and (d)(2); and add
paragraphs (d)(1)(iii) and (d)(3) to read
as follows:
§ 522.2478 Trenbolone acetate and
estradiol benzoate.
(a) Specifications—(1) Each implant
consists of:
(i) 8 pellets, each pellet containing 25
milligrams (mg) trenbolone acetate and
3.5 mg estradiol benzoate.
(ii) 4 pellets, each pellet containing 25
mg trenbolone acetate and 3.5 mg
estradiol benzoate.
(2) Each extended release implant
consists of:
(i) 8 pellets with a porous polymer
film coating, each pellet containing 25
mg trenbolone acetate and 3.5 mg
estradiol benzoate.
(ii) 6 pellets with a porous polymer
film coating, each pellet containing 25
mg trenbolone acetate and 3.5 mg
estradiol benzoate.
*
*
*
*
*
(d) * * *
(1) * * *
(i) For an implant as described in
paragraph (a)(1)(i) of this section:
*
*
*
*
*
(ii) For an implant as described in
paragraph (a)(1)(ii) of this section:
*
*
*
*
*
(iii) For an implant as described in
paragraph (a)(2)(i) of this section:
(A) Amount. 200 mg trenbolone
acetate and 28 mg estradiol benzoate in
an extended release implant.
(B) Indications for use. For increased
rate of weight gain and improved feed
efficiency for up to 200 days.
(C) Limitations. Implant
subcutaneously in ear only. Safety and
effectiveness have not been established
in veal calves. A withdrawal period has
PO 00000
Frm 00060
Fmt 4700
Sfmt 4700
*
*
not been established for this product in
preruminating calves. Do not use in
calves to be processed for veal.
(2) Heifers fed in confinement for
slaughter—(i) For an implant as
described in paragraph (a)(1)(i) of this
section:
(A) Amount. 200 mg trenbolone
acetate and 28 mg estradiol benzoate.
(B) Indications for use. For increased
rate of weight gain.
(C) Limitations. Implant
subcutaneously in ear only. Not for use
in dairy or beef replacement heifers.
Safety and effectiveness have not been
established in veal calves. A withdrawal
period has not been established for this
product in preruminating calves. Do not
use in calves to be processed for veal.
(ii) For an implant as described in
paragraph (a)(1)(ii) of this section:
(A) Amount. 100 mg trenbolone
acetate and 14 mg estradiol benzoate.
(B) Indications for use. For increased
rate of weight gain and improved feed
efficiency.
(C) Limitations. Implant
subcutaneously in ear only. Not for use
in dairy or beef replacement heifers.
Safety and effectiveness have not been
established in veal calves. A withdrawal
period has not been established for this
product in preruminating calves. Do not
use in calves to be processed for veal.
(iii) For an implant as described in
paragraph (a)(2)(i) of this section:
(A) Amount. 200 mg trenbolone
acetate and 28 mg estradiol benzoate in
an extended release implant.
(B) Indications for use. For increased
rate of weight gain and improved feed
efficiency for up to 200 days.
(C) Limitations. Implant
subcutaneously in ear only. Not for use
in dairy or beef replacement heifers.
Safety and effectiveness have not been
established in veal calves. A withdrawal
period has not been established for this
product in preruminating calves. Do not
use in calves to be processed for veal.
(3) Pasture steers and heifers
(slaughter, stocker, and feeder)—(i) For
an implant as described in paragraph
(a)(2)(ii) of this section:
(A) Amount. 150 mg trenbolone
acetate and 21 mg estradiol benzoate in
an extended release implant.
(B) Indications for use. For increased
rate of weight gain for up to 200 days.
(C) Limitations. Implant
subcutaneously in ear only. Not for use
in dairy or beef replacement heifers.
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Federal Register / Vol. 79, No. 208 / Tuesday, October 28, 2014 / Rules and Regulations
Safety and effectiveness have not been
established in veal calves. A withdrawal
period has not been established for this
product in preruminating calves. Do not
use in calves to be processed for veal.
(ii) [Reserved]
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG–2014–0747]
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
RIN 1625–AA00
Safety Zone; Allegheny River; Mile
45.7; Kittanning, PA
11. The authority citation for 21 CFR
part 524 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing a temporary safety zone on
the Allegheny River at mile 45.7. This
safety zone is needed to protect vessels
transiting the area and event spectators
from the hazards associated with a
barge-based fireworks display. Entry
into this zone is prohibited unless
specifically authorized by the Captain of
the Port (COTP) Pittsburgh or a
designated representative.
DATES: This rule is effective from 8:30
p.m. until 10:00 p.m. on November 21,
2014.
ADDRESSES: Documents mentioned in
this preamble are part of docket USCG–
2014–0747. To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type the docket
number in the ‘‘SEARCH’’ box and click
‘‘SEARCH.’’ Click on Open Docket
Folder on the line associated with this
rulemaking. You may also visit the
Docket Management Facility in Room
W12–140 on the ground floor of the
Department of Transportation West
Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call or
email Jennifer Haggins, Marine Safety
Unit Pittsburgh, U.S. Coast Guard, at
telephone 412–644–5808, email
Jennifer.L.Haggins@uscg.mil. If you have
questions on viewing or submitting
material to the docket, call Cheryl F.
Collins, Program Manager, Docket
Operations, telephone (202) 366–9826.
SUPPLEMENTARY INFORMATION:
SUMMARY:
§ 524.1580a
[Amended]
12. In paragraph (b)(1) of § 524.1580a,
remove ‘‘Nos. 050749, 054628, 054925,
058005, and 061623’’ and add in its
place ‘‘Nos. 054628, 054925, 058005,
059051, and 061623’’.
■
§ 524.1580b
[Amended]
13. In paragraph (b) of § 524.1580b,
remove ‘‘No. 054628’’ and in its place
add ‘‘Nos. 054628 and 059051’’.
■
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
14. The authority citation for 21 CFR
part 556 continues to read as follows:
■
Authority: 21 U.S.C. 342, 360b, 371.
15. In § 556.344, revise paragraphs (a),
(b)(1)(i), and (b)(2)(ii); and add
paragraph (c) to read as follows:
■
§ 556.344
Ivermectin.
asabaliauskas on DSK5VPTVN1PROD with RULES
(a) Acceptable Daily Intake (ADI). The
ADI for total residues of ivermectin is 5
micrograms per kilogram of body weight
per day.
(b) * * *
(1) * * *
(i) Cattle. 1.6 parts per million.
(2) * * *
(ii) Cattle. 650 parts per billion.
(c) Related conditions of use. See
§§ 520.1192, 520.1195, 520.1197,
522.1192, 522.1193, 524.1193, and
558.300 of this chapter.
Dated: October 23, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014–25588 Filed 10–27–14; 8:45 am]
Table of Acronyms
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
BILLING CODE 4164–01–P
A. Regulatory History and Information
The Coast Guard is issuing this
temporary final rule without prior
notice and opportunity to comment
VerDate Sep<11>2014
16:44 Oct 27, 2014
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64117
pursuant to authority under section 4(a)
of the Administrative Procedure Act
(APA) (5 U.S.C. 553(b)). This provision
authorizes an agency to issue a rule
without prior notice and opportunity to
comment when the agency for good
cause finds that those procedures are
‘‘impracticable, unnecessary, or contrary
to the public interest.’’ Under 5 U.S.C.
553(b)(B), the Coast Guard finds that
good cause exists for not using the
NPRM process. Upon receiving notice of
this display and after full review of the
event information and location, the
Coast Guard determined that a safety
zone is necessary. Delaying this rule by
completing the full NPRM process
would unnecessarily delay the safety
zone and be contrary to public interest
because the safety zone is needed to
protect transiting vessels, spectators,
and the personnel involved in the
display from the hazards associated
with fireworks displays taking place
over the waterway. Completing the full
NPRM process could also unnecessarily
delay the locally advertised and
planned event and possibly interfere
with contractual obligations.
Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for
making this temporary rule effective less
than 30 days after publication in the
Federal Register for the same reasons
discussed in the preceding paragraph,
waiting for a 30 day notice period to run
would be impracticable and contrary to
the public interest.
B. Basis and Purpose
On November 21, 2014, as a part of
Light Up Night, Downtown Kittanning
Inc. will sponsor a barge-based
fireworks display. The display will take
place in the vicinity of mile 45.7 on the
Allegheny River. This event presents
safety hazards for spectators and vessels
navigating in the area, and therefore a
safety zone is needed to protect persons
and property from the hazards
associated with a fireworks display over
the waterway.
The legal basis and authorities for this
rule are found in 33 U.S.C. 1231; 46
U.S.C. Chapter 701, 3306, 3703; 50
U.S.C. 191, 195; 33 CFR 1.05–1, 6.04–1,
6.04–6, and 160.5; Public Law 107–295,
116 Stat. 2064; and Department of
Homeland Security Delegation No.
0170.1, which collectively authorize the
Coast Guard to establish and define
regulatory safety zones.
C. Discussion of the Final Rule
The Coast Guard is establishing a
safety zone for all waters of the
Allegheny River, mile 45.7, extending
the entire width of the river. Entry into
this zone is prohibited to all vessels and
E:\FR\FM\28OCR1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 208 (Tuesday, October 28, 2014)]
[Rules and Regulations]
[Pages 64114-64117]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25588]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and 556
[Docket No. FDA-2014-N-0002]
New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and
Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate;
Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor
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 (NADAs) and abbreviated new animal drug applications
(ANADAs) during August 2014. FDA is also informing the public of the
availability of summaries of the basis of approval and of environmental
review documents, where applicable. The animal drug regulations are
also being amended to reflect a change of sponsorship of two NADAs and
one ANADA, and to reflect a revised food safety warning.
DATES: This rule is effective October 28, 2014.
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 NADAs and ANADAs during August 2014, 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 CVM FOIA Electronic Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and
patent information may be accessed in FDA's publication, Approved
Animal Drug Products Online (Green Book) at: https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
In addition, Macleod Pharmaceuticals, Inc., 2600 Canton Ct., Fort
Collins, CO 80525 has transferred ownership of, and all rights and
interest in ANADA 200-033 for UNIPRIM (trimethoprim and sulfadiazine)
Powder to Neogen Corp. (Neogen), 944 Nandino Blvd., Lexington, KY
40511. In 2004, Hess & Clark, Inc., transferred ownership of, and all
rights and interest in NADA 011-154 for NFZ Puffer (nitrofurazone
soluble powder) and NADA 140-851 for NFZ Wound Dressing (nitrofurazone
ointment) to Neogen. At this time, the regulations are being amended to
reflect these transfers.
Following these changes of sponsorship, Macleod Pharmaceuticals,
Inc., and Hess & Clark, Inc., will no longer be the sponsor of an
approved application. Accordingly, 21 CFR 510.600(c) is being amended
to remove the entries for these firms.
Also, the animal drug regulations are being amended in 21 CFR
522.690 to revise a human food safety warning for dinoprost
tromethamine injectable solution. This amendment is being made 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 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 August 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
New animal drug
NADA/ANADA Sponsor product name Action 21 CFR Sections FOIA Summary NEPA Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
140-833........... Merial Ltd., 3239 IVOMEC Plus Supplemental approval 522.1193............ yes................. CE.1 2
Satellite Blvd., (ivermectin and reducing the 556.344.............
Bldg. 500, Duluth, clorsulon) Injection preslaughter
GA 30096-4640. for Cattle. withdrawal period
from 49 days to 21
days.
141-043........... Zoetis Inc., 333 SYNOVEX CHOICE Supplemental approval 522.2478............ yes................. EA/FONSI.\3\
Portage St., (trenbolone and for increased rate
Kalamazoo, MI 49007. estradiol implant). of weight gain and
improved feed
efficiency in
heifers fed in
confinement for
slaughter.
141-342........... Jurox Pty. Ltd., 85 ALFAXAN (alfaxalone) Supplemental approval 522.52.............. no.................. CE.1 4
Gardiner Rd., Injectable adding a label
Rutherford, NSW Anesthetic for Dogs statement that
2320, Australia. and Cats. alfaxalone is a
Class IV controlled
substance.
[[Page 64115]]
141-348........... Zoetis Inc., 333 SYNOVEX ONE FEEDLOT Original approval for 522.2478............ yes................. EA/FONSI.1 3
Portage St., (trenbolone and increased rate of
Kalamazoo, MI 49007. estradiol extended weight gain and
release implant). improved feed
SYNOVEX ONE GRASS efficiency for up to
(trenbolone and 200 days in steers
estradiol extended and heifers fed in
release implant). confinement for
slaughter.
Original approval for
increased rate of
weight gain for up
to 200 days in
pasture steers and
heifers (slaughter,
stocker, and feeder).
200-455 \5\....... Cross Vetpharm Group TYLOMED-WS (tylosin Supplemental approval 520.2640............ no.................. CE.1 6
Ltd. Broomhill Rd., tartrate) Soluble of a change to
Tallaght,. Powder. veterinary
Dublin 24, Ireland... prescription (Rx)
marketing status to
conform with
reference (pioneer)
product.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.
\2\ CE granted under 21 CFR 25.33(a).
\3\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
no significant impact (FONSI).
\4\ CE granted under 21 CFR 25.33(d)(1).
\5\ This application was listed as being affected by guidance for industry (GFI) #213, ``New Animal Drugs and New Animal Drug Combination Products
Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product
Use Conditions with GFI #209'', December 2013.
\6\ CE granted under 21 CFR 25.33(a)(1).
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, and 524
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 510,
520, 522, 524, and 556 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.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), remove the
entries for ``Macleod Pharmaceuticals, Inc.'' and ``Hess & Clark,
Inc.'' and alphabetically add an entry for ``Neogen Corp.''; and in the
table in paragraph (c)(2), remove the entries for ``058711'' and
``050749'' and numerically add an entry for ``059051'' to read as
follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * * * *
Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511.... 059051
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler
code Firm name and address
------------------------------------------------------------------------
* * * * * * *
059051 Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511
[[Page 64116]]
* * * * * * *
------------------------------------------------------------------------
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.2613 [Amended]
0
4. In paragraph (b) of Sec. 520.2613, remove ``058711'' and in its
place add ``059051''.
0
5. In Sec. 520.2640, revise paragraphs (b), (d), and (e)(2)(ii) to
read as follows:
Sec. 520.2640 Tylosin.
* * * * *
(b) Sponsors--(1) No. 000986 for use as in paragraph (e) of this
section.
(2) Nos. 016592 and 061623 for use as in paragraphs (e)(1)(i)(A),
(e)(1)(ii), (e)(2), (e)(3), and (e)(4) of this section.
* * * * *
(d) Special considerations. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
(e) * * *
(2) * * *
(ii) Indications for use. For the reduction in severity of effects
of infectious sinusitis associated with Mycoplasma gallisepticum.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
6. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
7. In Sec. 522.52, in paragraph (c)(3), add a second sentence to read
as follows:
Sec. 522.52 Alfaxalone.
* * * * *
(c) * * *
(3) * * * Alfaxalone is a Class IV controlled substance.
0
8. In Sec. 522.690, revise paragraph (d)(1)(iii) to read as follows:
Sec. 522.690 Dinoprost.
* * * * *
(d) * * *
(1) * * *
(iii) Limitations. Do not use in horses intended for human
consumption.
* * * * *
0
9. In Sec. 522.1193, revise paragraph (e)(3) to read as follows:
Sec. 522.1193 Ivermectin and clorsulon.
* * * * *
(e) * * *
(3) Limitations. For No. 050604: Do not treat cattle within 21 days
of slaughter. For Nos. 055529 and 058005: Do not treat cattle within 49
days of slaughter. Because a withdrawal time in milk has not been
established, do not use in female dairy cattle of breeding age. A
withdrawal period has not been established for preruminating calves. Do
not use in calves to be processed for veal.
0
10. In Sec. 522.2478, revise paragraphs (a), (d)(1)(i) introductory
text, (d)(1)(ii) introductory text, and (d)(2); and add paragraphs
(d)(1)(iii) and (d)(3) to read as follows:
Sec. 522.2478 Trenbolone acetate and estradiol benzoate.
(a) Specifications--(1) Each implant consists of:
(i) 8 pellets, each pellet containing 25 milligrams (mg) trenbolone
acetate and 3.5 mg estradiol benzoate.
(ii) 4 pellets, each pellet containing 25 mg trenbolone acetate and
3.5 mg estradiol benzoate.
(2) Each extended release implant consists of:
(i) 8 pellets with a porous polymer film coating, each pellet
containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate.
(ii) 6 pellets with a porous polymer film coating, each pellet
containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate.
* * * * *
(d) * * *
(1) * * *
(i) For an implant as described in paragraph (a)(1)(i) of this
section:
* * * * *
(ii) For an implant as described in paragraph (a)(1)(ii) of this
section:
* * * * *
(iii) For an implant as described in paragraph (a)(2)(i) of this
section:
(A) Amount. 200 mg trenbolone acetate and 28 mg estradiol benzoate
in an extended release implant.
(B) Indications for use. For increased rate of weight gain and
improved feed efficiency for up to 200 days.
(C) Limitations. Implant subcutaneously in ear only. Safety and
effectiveness have not been established in veal calves. A withdrawal
period has not been established for this product in preruminating
calves. Do not use in calves to be processed for veal.
(2) Heifers fed in confinement for slaughter--(i) For an implant as
described in paragraph (a)(1)(i) of this section:
(A) Amount. 200 mg trenbolone acetate and 28 mg estradiol benzoate.
(B) Indications for use. For increased rate of weight gain.
(C) Limitations. Implant subcutaneously in ear only. Not for use in
dairy or beef replacement heifers. Safety and effectiveness have not
been established in veal calves. A withdrawal period has not been
established for this product in preruminating calves. Do not use in
calves to be processed for veal.
(ii) For an implant as described in paragraph (a)(1)(ii) of this
section:
(A) Amount. 100 mg trenbolone acetate and 14 mg estradiol benzoate.
(B) Indications for use. For increased rate of weight gain and
improved feed efficiency.
(C) Limitations. Implant subcutaneously in ear only. Not for use in
dairy or beef replacement heifers. Safety and effectiveness have not
been established in veal calves. A withdrawal period has not been
established for this product in preruminating calves. Do not use in
calves to be processed for veal.
(iii) For an implant as described in paragraph (a)(2)(i) of this
section:
(A) Amount. 200 mg trenbolone acetate and 28 mg estradiol benzoate
in an extended release implant.
(B) Indications for use. For increased rate of weight gain and
improved feed efficiency for up to 200 days.
(C) Limitations. Implant subcutaneously in ear only. Not for use in
dairy or beef replacement heifers. Safety and effectiveness have not
been established in veal calves. A withdrawal period has not been
established for this product in preruminating calves. Do not use in
calves to be processed for veal.
(3) Pasture steers and heifers (slaughter, stocker, and feeder)--
(i) For an implant as described in paragraph (a)(2)(ii) of this
section:
(A) Amount. 150 mg trenbolone acetate and 21 mg estradiol benzoate
in an extended release implant.
(B) Indications for use. For increased rate of weight gain for up
to 200 days.
(C) Limitations. Implant subcutaneously in ear only. Not for use in
dairy or beef replacement heifers.
[[Page 64117]]
Safety and effectiveness have not been established in veal calves. A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.
(ii) [Reserved]
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
11. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1580a [Amended]
0
12. In paragraph (b)(1) of Sec. 524.1580a, remove ``Nos. 050749,
054628, 054925, 058005, and 061623'' and add in its place ``Nos.
054628, 054925, 058005, 059051, and 061623''.
Sec. 524.1580b [Amended]
0
13. In paragraph (b) of Sec. 524.1580b, remove ``No. 054628'' and in
its place add ``Nos. 054628 and 059051''.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
14. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
15. In Sec. 556.344, revise paragraphs (a), (b)(1)(i), and (b)(2)(ii);
and add paragraph (c) to read as follows:
Sec. 556.344 Ivermectin.
(a) Acceptable Daily Intake (ADI). The ADI for total residues of
ivermectin is 5 micrograms per kilogram of body weight per day.
(b) * * *
(1) * * *
(i) Cattle. 1.6 parts per million.
(2) * * *
(ii) Cattle. 650 parts per billion.
(c) Related conditions of use. See Sec. Sec. 520.1192, 520.1195,
520.1197, 522.1192, 522.1193, 524.1193, and 558.300 of this chapter.
Dated: October 23, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-25588 Filed 10-27-14; 8:45 am]
BILLING CODE 4164-01-P
