[Federal Register Volume 79, Number 208 (Tuesday, October 28, 2014)]
[Rules and Regulations]
[Pages 64114-64117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-25588]
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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.
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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,
[email protected].
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: http://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: http://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
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New animal drug
NADA/ANADA Sponsor product name Action 21 CFR Sections FOIA Summary NEPA Review
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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.
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\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) * * *
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Drug labeler
Firm name and address code
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* * * * * * *
Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511.... 059051
* * * * * * *
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(2) * * *
------------------------------------------------------------------------
Drug labeler
code Firm name and address
------------------------------------------------------------------------
* * * * * * *
059051 Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511
[[Page 64116]]
* * * * * * *
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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