[Federal Register Volume 79, Number 39 (Thursday, February 27, 2014)]
[Rules and Regulations]
[Pages 10963-10965]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-01959]
[[Page 10963]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 526, 529, and 558
[Docket No. FDA-2014-N-0002]
New Animal Drugs; Bambermycins; Clopidol; Ivermectin; Penicillin
G Procaine and Dihydrostreptomycin Sulfate; Progesterone; Robenicoxib;
Sulfadimethoxine; Change of Sponsor; Change of Sponsor's Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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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 December 2013. 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 an NADA and a
change to a sponsor's address.
DATES: This rule is effective February 27, 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 December 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 FOIA
Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.
In addition, West Agro, Inc., 11100 North Congress Ave., Kansas
City, MO 64153 has informed FDA that it has transferred ownership of,
and all rights and interest in, NADA 055-028 for QUARTERMASTER
(penicillin G procaine and dihydrostreptomycin sulfate) Dry Cow
Treatment to HQ Specialty Pharma Corp., 120 Rte. 17 North, Suite 130,
Paramus, NJ 07652. Following this change of sponsorship, West Agro,
Inc., is no longer a sponsor of an approved NADA, and HQ Specialty
Pharma Corp. is now the sponsor of an approved NADA. Also, Putney,
Inc., 400 Congress St., Suite 200, Portland, ME 04101 has informed FDA
of a change of address to One Monument Sq., Suite 400, Portland, ME
04101. Accordingly, the Agency is amending the regulations to reflect
this change of sponsorship and change of sponsor's address.
Table 1--Original and Supplemental NADAs and ANADAs Approved During December 2013
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New animal drug 21 CFR
NADA/ANADA Sponsor product name Action Section FOIA summary NEPA review
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141-419............... Huvepharma AD, 5th COYDEN 25 (clopidol) Original approval as 558.95, Yes.................. CE.1 2
Floor, 3A Nikolay plus FLAVOMYCIN an aid in 558.175
Haytov St., 1113 (bambermycins) Type prevention of
Sophia, Bulgaria. A medicated articles. coccidiosis caused
by Eimeria tenella,
E. necatrix, E.
acervulina, E.
maxima, E.
brunetti, and E.
mivati; and for
increased rate of
weight gain and
improved feed
efficiency in
broiler chickens.
200-523............... Cross Vetpharm Group SULFAMED Original approval as 522.2220 Yes.................. CE.1 3
Ltd., Broomhill Rd., (sulfadimethoxine) a generic copy of
Tallaght, Dublin 24, 40% Injectable NADA 041-245.
Ireland. Solution.
200-564............... Merial Ltd., 3239 Ivermectin Paste Original approval as \4\ N/A Yes.................. CE.1 3
Satellite Blvd., 1.87%. a generic copy of
Bldg. 500, Duluth, NADA 134-314.
GA 30096-4640.
141-200............... Zoetis Inc., 333 EAZI-BREED CIDR Supplemental 529.1940 Yes.................. EA/FONSI.\5\
Portage St., (progesterone approval for
Kalamazoo, MI 49007. intravaginal insert) induction of
Cattle Insert. estrous cycles in
anestrous lactating
dairy cattle.
141-320............... Novartis Animal ONSIOR (robenacoxib) Supplemental 520.2075 Yes.................. CE.1 6
Health US, Inc., Tablets. approval lowering
3200 Northline Ave., age at treatment
Suite 300, from 6 months to 4
Greensboro, NC 27408. months.
[[Page 10964]]
200-341............... Sparhawk SPARMECTIN-E Supplemental 520.1195 Yes.................. CE.1 3
Laboratories, Inc., (ivermectin) Liquid. approval adding
12340 Santa Fe Trail pathogens off
Dr., Lenexa, KS exclusivity to
66215. labeling.
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\1\ The Agency has determined under Sec. 25.33 (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 because it is of a type that does not individually or cumulatively have a
significant effect on the human environment.
\2\ CE granted under Sec. 25.33(a)(2).
\3\ CE granted under Sec. 25.33(a)(1).
\4\ 21 CFR 520.1192 already contains a drug labeler code entry for this sponsor.
\5\ The Agency has carefully considered an EA of the potential environmental impact of this action and has made a finding of no significant impact
(FONSI).
\6\ CE granted under Sec. 25.33(d)(1).
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 526, and 529
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 510,
520, 522, 526, 529, 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.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), alphabetically
add an entry for ``HQ Specialty Pharma Corp.'', revise the entry for
``Putney, Inc.'', and remove the entry for ``West Agro, Inc.''; and in
the table in paragraph (c)(2), revise the entry for ``026637'', remove
the entry for ``033392'', and numerically add an entry for ``042791''
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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* * * * *
HQ Specialty Pharma Corp., 120 Rte. 17 North, Suite 130, 042791
Paramus, NJ 07652......................................
* * * * *
Putney, Inc., One Monument Sq., Suite 400, Portland, ME 026637
04101..................................................
* * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * *
026637.................................... Putney, Inc., One Monument
Sq., Suite 400, Portland,
ME 04101.
* * * * *
042791.................................... HQ Specialty Pharma Corp.,
120 Rte. 17 North, Suite
130, Paramus, NJ 07652.
* * * * *
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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.
0
4. In Sec. 520.1195, revise paragraphs (b)(1) and (b)(2) to read as
follows:
Sec. 520.1195 Ivermectin liquid.
* * * * *
(b) * * *
(1) Nos. 000859, 050604, 054925, and 058005 for use of product
described in paragraph (a)(1) of this section as in paragraphs
(e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section.
(2) No. 058829 for use of product described in paragraph (a)(1) of
this section as in paragraphs (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii)
of this section.
* * * * *
Sec. 520.2075 [Amended]
0
5. In Sec. 520.2075, in paragraph (c)(2), remove ``at least 6 months
of age'' and in its place add ``at least 4 months of age''.
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. 522.2220, revise paragraphs (a)(1), (a)(2), and (a)(3)(iii)
to read as follows:
Sec. 522.2220 Sulfadimethoxine.
(a)(1) Specifications. Each milliliter of solution contains 400
milligrams (mg) sulfadimethoxine.
(2) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter for conditions of use as in paragraph (a)(3) of this section:
(i) No. 054771 for use as in paragraph (a)(3) of this section.
(ii) Nos. 000859, 057561, and 061623 for conditions of use as in
paragraph (a)(3)(iii) of this section.
(3) * * *
(iii) Cattle--(a) Amount. Administer an initial dose of 25 mg per
pound of body weight by intravenous injection followed by 12.5 mg per
pound of body weight every 24 hours until the animal is asymptomatic
for 48 hours.
(b) Indications for use. For the treatment of bovine respiratory
disease complex (shipping fever complex) and bacterial pneumonia
associated with Pasteurella spp. sensitive to sulfadimethoxine;
necrotic pododermatitis (foot rot) and calf diphtheria caused by
Fusobacterium necrophorum sensitive to sulfadimethoxine.
[[Page 10965]]
(c) Limitations. Milk taken from animals during treatment and for
60 hours (5 milkings) after the latest treatment must not be used for
food. Do not administer within 5 days of slaughter. A withdrawal period
has not been established for this product in preruminating calves. Do
not use in calves to be processed for veal.
* * * * *
PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
0
8. The authority citation for 21 CFR part 526 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 526.1696c [Amended]
0
9. In paragraph (b) of Sec. 526.1696c, remove ``033392'' and in its
place add ``042791''.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
10. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
11. In Sec. 529.1940, in paragraphs (b) and (e)(1)(iii), remove
``000009'' and in its place add ``054771''; in paragraph (c), remove
``Sec. 556.540(a)'' and in its place add ``Sec. 556.540''; and add
paragraph (e)(1)(ii)(D) to read as follows:
Sec. 529.1940 Progesterone intravaginal inserts.
* * * * *
(e) * * *
(1) * * *
(ii) * * *
(D) For induction of estrous cycles in anestrous lactating dairy
cows.
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
12. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
13. In paragraph (d)(5) of Sec. 558.95, redesignate paragraphs
(d)(5)(iii) through (d)(5)(x) as paragraphs (d)(5)(iv) through
(d)(5)(xi); and add new paragraph (d)(5)(iii) to read as follows:
Sec. 558.95 Bambermycins.
* * * * *
(d) * * *
(5) * * *
(iii) Clopidol as in Sec. 558.175.
* * * * *
0
14. In Sec. 558.175:
0
a. Redesignate paragraph (d)(9) as paragraph (d)(11).
0
b. Redesignate paragraphs (d)(5) through (d)(8) as paragraphs (d)(6)
through (d)(9).
0
c. Add new paragraphs (d)(5) and (d)(10).
The additions read as follows:
Sec. 558.175 Clopidol.
* * * * *
(d) * * *
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Clopidol in grams per Combination in grams
ton per ton Indications for use Limitations Sponsor
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* * * * * * *
(5) 113.5............ Bambermycins 1 to 2. Broiler chickens: As an Feed continuously as the 016592
aid in prevention of sole ration. Do not
coccidiosis caused by feed to chickens over
Eimeria tenella, E. 16 weeks of age
necatrix, E. acervulina,
E. maxima, E. brunetti,
and E. mivati; and for
increased rate of weight
gain and improved feed
efficiency
* * * * * * *
(10) 227............. Bambermycins 1 to 2. Broiler chickens: As an Feed continuously as 016592
aid in prevention of sole ration until 5
coccidiosis caused by days before slaughter.
Eimeria tenella, E. Withdraw 5 days before
necatrix, E. acervulina, slaughter or feed 113.5
E. maxima, E. brunetti, g/ton clopidol and 1 to
and E. mivati; and for 2 g/ton bambermycins
increased rate of weight during those 5 days
gain and improved feed before slaughter. Do
efficiency not feed to chickens
over 16 weeks of age
* * * * * * *
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Dated: January 27, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-01959 Filed 2-26-14; 8:45 am]
BILLING CODE 4160-01-P