New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Address, 61293-61298 [2015-25918]
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Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Rules and Regulations
R. Gil Kerlikowske,
Commissioner, U.S. Customs and Border
Protection.
Approved: October 5, 2015.
Mark J. Mazur,
Assistant Secretary of the Treasury.
formulas and 7.0 mg/100 kcal as the
maximum level of selenium in infant
formulas.
We gave interested persons until July
23, 2015, to file objections or requests
for a hearing. We received no objections
or requests for a hearing on the final
rule. Therefore, we find that the
effective date of the final rule that
published in the Federal Register of
June 22, 2016, should be confirmed.
[FR Doc. 2015–25729 Filed 10–9–15; 8:45 am]
BILLING CODE 9111–14–P; 9111–15–P; 9111–16–P;
9111–17–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
List of Subjects in 21 CFR Part 107
Food and Drug Administration
Food labeling, Infants and children,
Nutrition, Reporting and recordkeeping
requirements, Signs and symbols.
21 CFR Part 107
■
[Docket No. FDA–2013–N–0067]
Infant Formula: The Addition of
Minimum and Maximum Levels of
Selenium to Infant Formula and
Related Labeling Requirements;
Confirmation of Effective Date
AGENCY:
Food and Drug Administration,
HHS.
Therefore, under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321,
343, 350a, 371) and under authority
delegated to the Commissioner of Food
and Drugs, we are giving notice that no
objections or requests for a hearing were
filed in response to the June 23, 2015,
final rule. Accordingly, the amendments
issued thereby will become effective
June 22, 2016.
ACTION:
Final rule; confirmation of
effective date.
The Food and Drug
Administration (FDA or we) is
confirming the effective date of June 22,
2016, for the final rule that appeared in
the Federal Register of June 23, 2015.
The final rule amended the regulations
on nutrient specifications and labeling
for infant formula to add the mineral
selenium to the list of required nutrients
and to establish minimum and
maximum levels of selenium in infant
formula.
Dated: October 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–25960 Filed 10–9–15; 8:45 am]
SUMMARY:
Effective date of final rule
published in the Federal Register of
June 23, 2015 (80 FR 35834) confirmed:
June 22, 2016.
FOR FURTHER INFORMATION CONTACT:
Carrie Assar, Center for Food Safety and
Applied Nutrition (HFS–850), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740–3835,
240–402–1451.
SUPPLEMENTARY INFORMATION: In the
Federal Register of June 23, 2015 (80 FR
35834), we amended the regulations on
nutrient specifications and labeling for
infant formula to add 2.0 mg selenium
per 100 kilocalories (/100 kcal) as the
minimum level of selenium in infant
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 556,
and 558
[Docket No. FDA–2015–N–0002]
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DATES:
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New Animal Drugs; Approval of New
Animal Drug Applications; Withdrawal
of Approval of a New Animal Drug
Application; Change of Sponsor;
Change of Sponsor’s Address
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
application-related actions for new
animal drug applications (NADAs) and
abbreviated new animal drug
SUMMARY:
PO 00000
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61293
applications (ANADAs) during July and
August 2015. 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 sponsor, a change of
sponsor’s address, a revised food safety
warning, the voluntary withdrawal of
approval of an NADA, and a technical
amendment. This technical amendment
is being made to improve the accuracy
of the regulations.
This rule is effective October 13,
2015, except for the amendment to 21
CFR 558.460, which is effective October
23, 2015.
DATES:
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov.
FDA is
amending the animal drug regulations to
reflect approval actions for NADAs and
ANADAs during July and August 2015,
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.
SUPPLEMENTARY INFORMATION:
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Zoetis Inc., 333 Portage St., Kalamazoo, MI
49007.
Novartis Animal Health US, Inc., 3200
Northline Ave., Suite 300, Greensboro,
NC 27408.
141–442 ......................
Jkt 238001
PO 00000
Frm 00018
Zoetis Inc., 333 Portage St., Kalamazoo, MI
49007.
Akorn Animal Health, Inc., 1925 West Field
Ct., Suite 300, Lake Forest, IL 60045.
Putney, Inc., One Monument Sq., Suite
400, Portland, ME 04101.
Orkeo USA, Inc., 77 Water St., New York,
NY 10005.
Zoetis Inc., 333 Portage St., Kalamazoo, MI
49007.
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ENROFLOX 100 (enrofloxacin) Injectable
Solution.
TILMOVET 90 (tilmicosin phosphate) Type
A medicated article.
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc Ophthalmic Ointment, USP.
Thiabendazole, Dexamethasone, Neomycin
Sulfate Solution.
LONCOR 300 (florfenicol) Injectable Solution.
ACTOGAIN 45 (ractopamine hydrochloride)
plus RUMENSIN (monensin USP) plus
TYLOVET 100 (tylosin phosphate) plus
MGA (melengestrol acetate) Type C
medicated feeds.
ENGAIN 9 or 45 (ractopamine hydrochloride) plus TYLOVET 100 (tylosin
phosphate) Type B and Type C medicated feeds.
ACTOGAIN 45 (ractopamine hydrochloride)
plus RUMENSIN (monensin USP) plus
TYLOVET 100 (tylosin phosphate) Type
B and Type C medicated feeds.
NORFENICOL (florfenicol) Injectable Solution.
QUEST PLUS Gel (moxidectin/praziquantel)
STREP–SOL (streptomycin sulfate) Solution
25%.
LUTALYSE
HighCon
(dinoprost
tromethamine injection) Injection.
ONSIOR (robenacoxib) Injection .................
KAVAULT (avilamycin) Type A medicated
article.
Original approval as a generic copy of
NADA 141–063.
Supplemental approval for use in breeding,
pregnant, and lactating mares.
Supplemental approval of single-dose indications in cattle.
Supplemental approval for use of Type C
medicated feeds for control of bovine respiratory disease (BRD) in groups of beef
and non-lactating dairy cattle.
Original approval as a generic copy of
NADA 141–224.
Original approval as a generic copy of
NADA 141–172.
Original approval for the reduction in incidence and overall severity of diarrhea in
the presence of pathogenic Escherichia
coli in groups of weaned pigs.
Original approval of a higher concentration
formulation.
Original approval for the control of postoperative pain and inflammation associated
with
orthopedic
surgery,
ovariohysterectomy, and castration in
cats.
Supplemental approval to change marketing
status from over-the-counter to by veterinary prescription.
Original approval as a generic copy of
NADA 065–485.
Original approval as a generic copy of
NADA 042–633.
Original approval as a generic copy of
NADA 141–063.
Original approval as a generic copy of
NADA 141–233.
Action
yes ........
yes ........
yes ........
yes ........
yes ........
yes ........
yes ........
no ..........
yes ........
yes ........
yes ........
FOIA
summary
558.618
yes ........
yes ........
520.1453 6
522.812
yes ........
522.955
558.500
558.500
558.500
522.955
524.1484g
524.154
520.2158
522.2075
522.690
556.68
558.4
558.68
21 CFR
sections
CE.2 4
CE.2 4
CE.2 3
CE.2 4
CE.2 4
CE.2 4
CE.2 4
CE.2 4
CE.2 4
CE.2 4
CE.2 3
CE.2 3
CE.2 4
EA/FONSI.1
NEPA review
13OCR1
2 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).
Agency has determined 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
have a significant effect on the human environment.
3 CE granted under 21 CFR 25.33(d)(1).
4 CE granted under 21 CFR 25.33(a)(1).
5 This NADA was listed as being affected by 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 This supplemental approval required no change to the regulation.
1 The
200–509 ......................
200–495 ......................
141–216 ......................
Norbrook Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland.
Zoetis Inc., 333 Portage St., Kalamazoo, MI
49007.
Norbrook Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland.
Huvepharma AD, 5th Floor, 3A Nikolay
Haytov Str., 1113 Sofia, Bulgaria.
200–585 ......................
200–591 ......................
Zoetis Inc., 333 Portage St., Kalamazoo, MI
49007.
200–584 ......................
200–583 ......................
200–582 ......................
200–565 ......................
200–553 ......................
065–252 5 ....................
Huvepharma AD, 5th Floor, 3A Nikolay
Haytov Str.,1113 Sophia, Bulgaria.
Elanco Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center, Indianapolis, IN 46285.
141–438 ......................
141–443 ......................
Sponsor
New animal drug product name
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY AND AUGUST 2015
NADA/ANADA
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In addition, IMPAX Laboratories, Inc.,
30831 Huntwood Ave., Hayward, CA
94544 has informed FDA that it has
transferred ownership of, and all rights
and interest in, ANADA 200–366 for
NOVOCOX (carprofen sodium) Caplets
to Putney, Inc., One Monument Square,
suite 400, Portland, ME 04101.
File No.
Product name
21 CFR
section
200–366 ......................................................................................
NOVOCOX (carprofen sodium) Caplets ....................................
520.304
Also, Pharmgate LLC, 161 North
Franklin Turnpike, suite 2C, Ramsey, NJ
07446, has informed FDA that it has
changed its address to 1015 Ashes Dr.,
suite 102, Wilmington, NC 28405.
Accordingly, 21 CFR 510.600 is being
amended to reflect this change.
In addition, FDA is revising a human
food safety warning for use of
sulfamethazine soluble powder in preruminating calves. FDA is also changing
the drug labeler code for a generic
dinoprost injection product in 21 CFR
522.690, which in error was omitted
from a final rule changing sponsorship
of an application (78 FR 17595, March
22, 2013). Also, the strength of
lufenuron injectable suspension is also
being amended to conform to the
approved application. These technical
amendments are being made to improve
the accuracy of the regulations.
In addition, Zoetis Inc., 333 Portage
St., Kalamazoo, MI 49007 has requested
that FDA withdraw approval of NADA
046–666 that provides for use of Type
A medicated articles containing
penicillin G procaine to manufacture
medicated feeds administered to poultry
and swine. This action is being taken at
the sponsor’s request because this
product is no longer manufactured or
marketed. Note this NADA was
identified 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. Elsewhere in this issue of the
Federal Register, FDA gave notice that
approval of NADA 046–666, and all
supplements and amendments thereto,
is withdrawn, effective October 23,
2015. As provided in the regulatory text
of this document, the animal drug
regulations are amended to reflect this
voluntary withdrawal of approval.
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
21 CFR Part 556
Animal drugs, Foods.
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, 524, 556, and
558 are amended as follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for part 510
continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600, in the table in
paragraph (c)(1), add an entry for
‘‘Orkeo USA, Inc.’’ in alphabetical order
and revise the entry for ‘‘Pharmgate
LLC’’; and in the table in paragraph
(c)(2), revise the entry for ‘‘069254’’ and
add in numerical order an entry for
‘‘086050’’ to read as follows:
■
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
21 CFR Parts 520, 522, and 524
*
Animal drugs.
*
*
(c) * * *
(1) * * *
*
*
Drug labeler
code
Firm name and address
*
*
*
*
*
*
Orkeo USA, Inc., 77 Water St., New York, NY 10005 ........................................................................................................................
*
*
*
*
*
*
*
Pharmgate LLC, 1015 Ashes Dr., Suite 102, Wilmington, NC 28405 ................................................................................................
*
*
*
*
*
*
086050
069254
*
*
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(2) * * *
Drug labeler code
Firm name and address
*
*
069254 .....................................................
*
*
*
Pharmgate LLC, 1015 Ashes Dr., Suite 102, Wilmington, NC 28405.
*
*
*
*
086050 .....................................................
*
*
*
Orkeo USA, Inc., 77 Water St., New York, NY 10005.
*
*
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Drug labeler code
*
Firm name and address
*
*
*
*
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
calves may cause violative residues to
remain beyond the withdrawal time.
3. The authority citation for part 520
continues to read as follows:
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
■
Authority: 21 U.S.C. 360b.
§ 520.304
4. In § 520.304, in paragraph (b)(2),
remove ‘‘000115’’ and in numerical
sequence add ‘‘026637’’.
■ 5. In § 520.2158, revise paragraphs
(d)(1) and (2) and add paragraph (d)(3)
to read as follows:
■
§ 520.2158
Streptomycin.
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*
*
*
*
*
(d) * * *
(1) Calves—(i) Amount. 10 to 15
milligrams per pound (mg/pound) of
body weight (1.0 to 1.5 grams per
gallon) for up to 5 days.
(ii) Indications for use. For the
treatment of bacterial enteritis caused by
Escherichia coli and Salmonella spp.
susceptible to streptomycin.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) Swine—(i) Amount. 10 to 15 mg/
pound of body weight (1.0 to 1.5 grams
per gallon) for up to 4 days.
(ii) Indications for use. For the
treatment of bacterial enteritis caused by
Escherichia coli and Salmonella spp.
susceptible to streptomycin.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(3) Chickens—(i) Amount. 10 to 15
mg/pound of body weight (0.6 to 0.9
grams per gallon) for up to 5 days.
(ii) Indications for use. For the
treatment of nonspecific infectious
enteritis caused by organisms
susceptible to streptomycin.
(iii) Limitations. Withdraw 4 days
before slaughter. Do not administer to
chickens producing eggs for human
consumption. Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.
■ 6. In § 520.2261b, in paragraph
(d)(4)(iii), revise the last two sentences
to read as follows:
§ 520.2261b
Sulfamethazine powder.
*
*
*
*
*
(d) * * *
(4) * * *
(iii) * * * Do not use in calves under
one (1) month of age or calves being fed
an all-milk diet. Use in these classes of
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7. The authority citation for part 522
continues to read as follows:
■
[Amended]
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Authority: 21 U.S.C. 360b.
8. Amend § 522.690 as follows:
a. Revise paragraphs (a), (b), and (c);
b. Redesignate paragraphs (d)(1) and
(2) as paragraphs (d)(2) and (4),
respectively, and add new paragraph
(d)(1);
■ c. In newly redesignated paragraph
(d)(2)(ii) and in paragraph (d)(3)(ii),
revise the paragraph heading
‘‘Indications’’, to read ‘‘Indications for
use’’; and
■ d. Revise newly redesignated
paragraph (d)(4) introductory text.
The revisions and addition read as
follows:
■
■
■
§ 522.690
Dinoprost.
(a) Specifications. Each milliliter (mL)
of solution contains dinoprost
tromethamine equivalent to 5
milligrams (mg) or 12.5 mg dinoprost.
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter.
(1) No. 054771 for use of the 12.5 mg/
mL product as in paragraph (d)(1) of this
section.
(2) Nos. 000859 and 054771 for use of
the 5 mg/mL product as in paragraphs
(d)(2), (d)(3), and (d)(4) of this section.
(c) Special considerations. Federal
law restricts this drug to use by or on
the order of a licensed veterinarian.
(d) * * *
(1) Cattle. Administer product
described in paragraph (b)(1) of this
section as follows:
(i) Amount. 25 mg as a single
intramuscular injection.
(ii) Indications for use. As a luteolytic
agent; effective only in those cattle
having a corpus luteum, i.e., those
which ovulated at least 5 days prior to
treatment.
(A) For estrus synchronization in beef
cows, beef heifers and replacement
dairy heifers.
(B) For unobserved (silent) estrus in
lactating dairy cows with a corpus
luteum.
(C) For treatment of pyometra
(chronic endometritis) in cattle.
(D) For abortion in beef cows, beef
heifers and replacement dairy heifers.
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*
*
(E) For use with gonadorelin injection
as in § 522.1077 of this chapter to
synchronize estrous cycles to allow
fixed-time artificial insemination (FTAI)
in lactating dairy cows.
(F) For use with progesterone
intravaginal inserts as in § 529.1940 of
this chapter for synchronization of
estrus in lactating dairy cows.
(G) For use with progesterone
intravaginal inserts as in § 529.1940 of
this chapter for synchronization of
estrus in suckled beef cows and
replacement beef and dairy heifers,
advancement of first postpartum estrus
in suckled beef cows, and advancement
of first pubertal estrus in beef heifers.
*
*
*
*
*
(4) Cattle. Administer product
described in paragraph (b)(2) of this
section as follows:
*
*
*
*
*
■ 9. In § 522.812, revise paragraph (b)(2)
to read as follows:
§ 522.812
Enrofloxacin.
*
*
*
*
*
(b) * * *
(2) No. 055529 for use of product
described in paragraph (a)(1) of this
section as in paragraph (e)(1) of this
section, and use of product described in
paragraph (a)(2) in this section as in
paragraphs (e)(2), (e)(3)(i)(B), and
(e)(3)(ii) of this section.
*
*
*
*
*
■ 10. In § 522.955, revise paragraphs (a),
(b), (d)(1) subject heading, (d)(1)(i)
introductory text, (d)(1)(i)(C), (d)(1)(ii)
introductory text, and (d)(1)(ii)(C) to
read as follows:
§ 522.955
Florfenicol.
(a) Specifications. Each milliliter of
solution contains:
(1) 300 milligrams (mg) florfenicol in
the inactive vehicles 2-pyrrolidone and
triacetin.
(2) 300 mg florfenicol in the inactive
vehicles n-methyl-2-pyrrolidone,
propylene glycol, and polyethylene
glycol.
(3) 300 mg florfenicol in the inactive
vehicles 2-pyrrolidone and glycerol
formal.
(b) Sponsors. See sponsor numbers in
§ 510.600(c) of this chapter:
(1) No. 000061 for use of product
described in paragraph (a)(1) as in
paragraph (d)(1)(i); and
(2) Nos. 000061 and 086050 for use of
product described in paragraph (a)(2) as
in paragraph (d)(1)(ii).
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(3) No. 055529 for use of product
described in paragraph (a)(3) as in
paragraph (d)(1)(ii).
*
*
*
*
*
(d) * * *
(1) Beef and non-lactating dairy
cattle—(i) 300 mg per milliliter (mL)
florfenicol in the inactive vehicles 2pyrrolidone and triacetin:
*
*
*
*
*
(C) Limitations. Animals intended for
human consumption must not be
slaughtered within 44 days of treatment.
Do not use in female dairy cattle 20
months of age or older. Use of
florfenicol in this class of cattle may
cause milk residues. A withdrawal
period has not been established in preruminating calves. Do not use in calves
to be processed for veal. Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
(ii) 300 mg/mL florfenicol in the
inactive vehicles n-methyl-2pyrrolidone, propylene glycol, and
polyethylene glycol, or in 2-pyrrolidone
and glycerol formal:
(C) Limitations. Animals intended for
human consumption must not be
slaughtered within 28 days of the last
intramuscular treatment. Animals
intended for human consumption must
not be slaughtered within 33 days of
subcutaneous treatment. This product is
not approved for use in female dairy
cattle 20 months of age or older,
including dry dairy cows. Use in these
cattle may cause drug residues in milk
and/or in calves born to these cows. A
withdrawal period has not been
established in pre-ruminating calves. Do
not use in calves to be processed for
veal. Federal law restricts this drug to
use by or on the order of a licensed
veterinarian.
*
*
*
*
*
§ 522.1289
[Amended]
11. In § 522.1289, in paragraph (a),,
remove ‘‘10 milligrams’’ and in its place
add ‘‘100 milligrams’’.
■
■
12. Add § 522.2075 to read as follows:
§ 522.2075
Robenacoxib.
15. In § 524.1484g, revise paragraphs
(a) and (b) to read as follows:
■
(a) Specifications. Each milliliter of
solution contains 20 milligrams (mg)
robenacoxib.
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
(c) Conditions of use in cats—(1)
Amount. Administer 0.91 mg per pound
(2 mg/kilogram) by subcutaneous
injection, once daily, for a maximum of
3 days.
(2) Indications for use. For the control
of postoperative pain and inflammation
associated with orthopedic surgery,
ovariohysterectomy, and castration in
cats at least 4 months of age for a
maximum of 3 days.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 524.1484g Neomycin, thiabendazole, and
dexamethasone solution.
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
■
(a) Specifications. Each milliliter of
solution contains 40 milligrams (mg)
thiabendazole, 3.2 mg neomycin (from
neomycin sulfate), and 1 mg
dexamethasone.
(b) Sponsors. See Nos. 026637 and
050604 in § 510.600(c) of this chapter.
*
*
*
*
*
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
16. The authority citation for part 556
continues to read as follows:
■
Authority: 21 U.S.C. 342, 360b, 371.
17. Add § 556.68 to read as follows:
§ 556.68
13. The authority citation for part 524
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
14. In § 524.154, revise paragraphs
(a)(1) and (2) and (b)(2) to read as
follows:
■
§ 524.154 Bacitracin, neomycin, and
polymyxin B ophthalmic ointment.
(a) * * *
(1) 500 units bacitracin, 3.5
milligrams (mg) neomycin sulfate
(equivalent to 3.5 mg neomycin base),
and 10,000 units polymyxin B sulfate;
or
(2) 400 units bacitracin zinc, 5 mg
neomycin sulfate (equivalent to 3.5 mg
neomycin base), and 10,000 units
polymyxin B sulfate.
(b) * * *
(2) Nos. 000061, 043264, and 059399
for use of product described in
paragraph (a)(2) as in paragraph (c) of
this section.
*
*
*
*
*
Avilamycin.
(a) Acceptable Daily Intake (ADI). The
ADI for total residues of avilamycin is
1.1 milligram per kilogram of body
weight per day.
(b) Tolerances. A tolerance for
avilamycin is not required.
(c) Related conditions of use. See
§ 558.68 of this chapter.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
18. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
19. In § 558.4, in paragraph (d), in the
‘‘Category I’’ table, add an entry in
alphabetical order for ‘‘Avilamycin’’ to
read as follows:
■
§ 558.4 Requirement of a medicated feed
mill license.
*
*
*
(d) * * *
*
*
CATEGORY I
Assay limits
percent 1
Type A
*
*
*
Avilamycin .....................................................................
asabaliauskas on DSK5VPTVN1PROD with RULES
Drug
90–110
*
*
■
*
*
*
*
17:03 Oct 09, 2015
Jkt 238001
Assay limits
percent
Type B/C
*
*
3.65 g/lb (0.8%) ............................................................
*
80–110
*
§ 558.68
20. Add § 558.68 to read as follows:
VerDate Sep<11>2014
*
*
*
Type B maximum (200x)
*
Avilamycin.
(a) Specifications. Each pound of
Type A medicated article contains 90.7
grams of avilamycin.
PO 00000
Frm 00021
Fmt 4700
Sfmt 4700
*
*
(b) Sponsor. See No. 000986 in
§ 510.600(c) of this chapter.
(c) Special considerations—(1)
Federal law restricts avilamycin
E:\FR\FM\13OCR1.SGM
13OCR1
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Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Rules and Regulations
medicated feeds to use under a
veterinary feed directive (VFD) and the
professional supervision of a licensed
veterinarian. See § 558.6 of this chapter
for additional requirements.
(2) The expiration date of VFDs for
avilamycin medicated feeds must not
exceed 90 days from the date of
issuance. VFDs for avilamycin shall not
be refilled.
(d) Related tolerances. See § 556.68 of
this chapter.
(e) Conditions of use in swine—(1)
Amount. Feed at 73 grams avilamycin
per ton of Type C medicated feed (80
ppm) as the sole ration for 21
consecutive days. The veterinarian may
direct feeding for up to a total of 42
consecutive days, based on the clinical
assessment.
(2) Indications for use. Weaned pigs
less than 14 weeks of age: For the
reduction in incidence and overall
severity of diarrhea in the presence of
pathogenic Escherichia coli in groups of
weaned pigs.
(3) Limitations. Feed continuously as
the sole ration.
§ 558.460
[Amended]
21. In § 558.460, revise paragraphs (a)
and (b) to read as follows:
■
§ 558.460
Penicillin.
(a) Specifications. Type A medicated
articles containing 100 or 227 grams
penicillin procaine G or feed grade
penicillin procaine per pound.
(b) Sponsor: See No. 066104 in
§ 510.600(c) of this chapter.
*
*
*
*
*
§ 558.500
[Amended]
22. Amend § 558.500 as follows:
a. In paragraphs (e)(1)(ii), (iii), and
(iv), in the ‘‘Limitations’’ column,
remove the last sentence and in its place
add ‘‘Ractopamine as provided by Nos.
000986 or 054771; tylosin as provided
by Nos. 000986 or 016592 in
§ 510.600(c) of this chapter.’’.
■ b. In paragraphs (e)(2)(iv), (ix), and
(xiii), in the ‘‘Limitations’’ column,
remove the last sentence and in its place
add ‘‘Ractopamine as provided by Nos.
000986 or 054771 with monensin as
provided by No. 000986, and tylosin as
provided by Nos. 000986 or 016592 in
§ 510.600(c) of this chapter.’’.
■ c. In paragraph (e)(2)(x), in the
‘‘Limitations’’ column, to the last
sentence add ‘‘; or ractopamine as
provided by No. 054771 with monensin
as provided by No. 000986, tylosin
provided by No. 016592, and
melengestrol acetate provided by No.
054771 in § 510.600(c) of this chapter.’’
■
asabaliauskas on DSK5VPTVN1PROD with RULES
■
VerDate Sep<11>2014
17:03 Oct 09, 2015
Jkt 238001
§ 558.618
[Amended]
23. In § 558.618, in paragraph (e)(2)(i),
in the ‘‘Sponsor’’ column, add ‘‘016592’’
after ‘‘000986’’.
■
Dated: October 6, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015–25918 Filed 10–9–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
and redelegated to the Center for
Veterinary Medicine, and in accordance
with 21 CFR 514.116 Notice of
withdrawal of approval of application,
notice is given that approval of NADA
046–666, and all supplements and
amendments thereto, is hereby
withdrawn, effective October 23, 2015.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of this
application.
Food and Drug Administration
Dated: October 6, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
21 CFR Part 558
[FR Doc. 2015–25919 Filed 10–9–15; 8:45 am]
[Docket No. FDA–2015–N–0002]
BILLING CODE 4164–01–P
New Animal Drugs for Use in Animal
Feed; Withdrawal of Approval of a New
Animal Drug Application; Penicillin G
Procaine
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
HHS.
ACTION:
21 CFR Part 890
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of a new animal drug
application (NADA) providing for the
use of penicillin G procaine in
medicated feed of poultry and swine.
This action is being taken at the
sponsor’s request because this product
is no longer manufactured or marketed.
DATES: Withdrawal of approval is
effective October 23, 2015.
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5761,
sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Zoetis
Inc., 333 Portage St., Kalamazoo, MI
49007 has requested that FDA withdraw
approval of NADA 046–666 that
provides for use of Type A medicated
articles containing penicillin G procaine
to manufacture medicated feeds
administered to poultry and swine. This
action is being taken at the sponsor’s
request because this product is no
longer manufactured or marketed. Note
this NADA was identified as being
affected by guidance for industry #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.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
SUMMARY:
PO 00000
Food and Drug Administration
Food and Drug Administration,
Frm 00022
Fmt 4700
Sfmt 4700
[Docket No. FDA–2012–N–0378]
Physical Medicine Devices;
Reclassification of Shortwave
Diathermy for All Other Uses,
Henceforth To Be Known as
Nonthermal Shortwave Therapy
AGENCY:
Food and Drug Administration,
HHS.
Final order; technical
correction.
ACTION:
The Food and Drug
Administration (FDA) is issuing a final
order to reclassify shortwave diathermy
(SWD) for all other uses, a
preamendments class III device, into
class II (special controls), and to rename
the device ‘‘nonthermal shortwave
therapy’’ (SWT). FDA is also making a
technical correction in the regulation for
the carrier frequency for SWD and SWT
devices.
DATES: This order is effective on October
13, 2015. See further discussion in
Section IV, ‘‘Implementation Strategy.’’
FOR FURTHER INFORMATION CONTACT:
Michael J. Ryan, Center for Devices and
Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1615,
Silver Spring, MD 20993, 301–796–
6283, michael.ryan@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background—Regulatory Authorities
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as amended by the
Medical Device Amendments of 1976
(the 1976 amendments) (Pub. L. 94–
295), the Safe Medical Devices Act of
1990 (Pub. L. 101–629), the Food and
E:\FR\FM\13OCR1.SGM
13OCR1
]]>Agencies
[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Rules and Regulations]
[Pages 61293-61298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25918]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 556, and 558
[Docket No. FDA-2015-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of a New Animal Drug Application; Change of
Sponsor; Change of Sponsor's Address
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 application-related actions for new animal
drug applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during July and August 2015. 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 sponsor, a
change of sponsor's address, a revised food safety warning, the
voluntary withdrawal of approval of an NADA, and a technical amendment.
This technical amendment is being made to improve the accuracy of the
regulations.
DATES: This rule is effective October 13, 2015, except for the
amendment to 21 CFR 558.460, which is effective October 23, 2015.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-402-5689,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect approval actions for NADAs and ANADAs during July and August
2015, 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.
[[Page 61294]]
Table 1--Original and Supplemental NADAs and ANADAs Approved During July and August 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
New animal drug 21 CFR
NADA/ANADA Sponsor product name Action sections FOIA summary NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-438........................ Elanco Animal Health, KAVAULT (avilamycin) Original approval for 556.68 yes......... EA/FONSI.\1\
A Division of Eli Type A medicated the reduction in 558.4
Lilly & Co., Lilly article. incidence and overall 558.68
Corporate Center, severity of diarrhea
Indianapolis, IN in the presence of
46285. pathogenic
Escherichia coli in
groups of weaned pigs.
141-442........................ Zoetis Inc., 333 LUTALYSE HighCon Original approval of a 522.690 yes......... CE.2 4
Portage St., (dinoprost higher concentration
Kalamazoo, MI 49007. tromethamine formulation.
injection) Injection.
141-443........................ Novartis Animal Health ONSIOR (robenacoxib) Original approval for 522.2075 yes......... CE.2 3
US, Inc., 3200 Injection. the control of
Northline Ave., Suite postoperative pain
300, Greensboro, NC and inflammation
27408. associated with
orthopedic surgery,
ovariohysterectomy,
and castration in
cats.
065-252 \5\.................... Huvepharma AD, 5th STREP-SOL Supplemental approval 520.2158 no.......... CE.2 3
Floor, 3A Nikolay (streptomycin to change marketing
Haytov Str.,1113 sulfate) Solution 25%. status from over-the-
Sophia, Bulgaria. counter to by
veterinary
prescription.
200-553........................ Akorn Animal Health, Neomycin and Polymyxin Original approval as a 524.154 yes......... CE.2 4
Inc., 1925 West Field B Sulfates, generic copy of NADA
Ct., Suite 300, Lake Bacitracin Zinc 065-485.
Forest, IL 60045. Ophthalmic Ointment,
USP.
200-565........................ Putney, Inc., One Thiabendazole, Original approval as a 524.1484g yes......... CE.2 4
Monument Sq., Suite Dexamethasone, generic copy of NADA
400, Portland, ME Neomycin Sulfate 042-633.
04101. Solution.
200-582........................ Orkeo USA, Inc., 77 LONCOR 300 Original approval as a 522.955 yes......... CE.2 4
Water St., New York, (florfenicol) generic copy of NADA
NY 10005. Injectable Solution. 141-063.
200-583........................ Zoetis Inc., 333 ACTOGAIN 45 Original approval as a 558.500 yes......... CE.2 4
Portage St., (ractopamine generic copy of NADA
Kalamazoo, MI 49007. hydrochloride) plus 141-233.
RUMENSIN (monensin
USP) plus TYLOVET 100
(tylosin phosphate)
plus MGA
(melengestrol
acetate) Type C
medicated feeds.
200-584........................ Zoetis Inc., 333 ENGAIN 9 or 45 Original approval as a 558.500 yes......... CE.2 4
Portage St., (ractopamine generic copy of NADA
Kalamazoo, MI 49007. hydrochloride) plus 141-172.
TYLOVET 100 (tylosin
phosphate) Type B and
Type C medicated
feeds.
200-585........................ Zoetis Inc., 333 ACTOGAIN 45 Original approval as a 558.500 yes......... CE.2 4
Portage St., (ractopamine generic copy of NADA
Kalamazoo, MI 49007. hydrochloride) plus 141-224.
RUMENSIN (monensin
USP) plus TYLOVET 100
(tylosin phosphate)
Type B and Type C
medicated feeds.
200-591........................ Norbrook Laboratories, NORFENICOL Original approval as a 522.955 yes......... CE.2 4
Ltd., Station Works, (florfenicol) generic copy of NADA
Newry BT35 6JP, Injectable Solution. 141-063.
Northern Ireland.
141-216........................ Zoetis Inc., 333 QUEST PLUS Gel Supplemental approval 520.1453 \6\ yes......... CE.2 3
Portage St., (moxidectin/ for use in breeding,
Kalamazoo, MI 49007. praziquantel). pregnant, and
lactating mares.
200-495........................ Norbrook Laboratories, ENROFLOX 100 Supplemental approval 522.812 yes......... CE.2 4
Ltd., Station Works, (enrofloxacin) of single-dose
Newry BT35 6JP, Injectable Solution. indications in cattle.
Northern Ireland.
200-509........................ Huvepharma AD, 5th TILMOVET 90 Supplemental approval 558.618 yes......... CE.2 4
Floor, 3A Nikolay (tilmicosin for use of Type C
Haytov Str., 1113 phosphate) Type A medicated feeds for
Sofia, Bulgaria. medicated article. control of bovine
respiratory disease
(BRD) in groups of
beef and non-
lactating dairy
cattle.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ 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).
\2\ The Agency has determined 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 have a significant effect on the human environment.
\3\ CE granted under 21 CFR 25.33(d)(1).
\4\ CE granted under 21 CFR 25.33(a)(1).
\5\ This NADA was listed as being affected by 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\ This supplemental approval required no change to the regulation.
[[Page 61295]]
In addition, IMPAX Laboratories, Inc., 30831 Huntwood Ave.,
Hayward, CA 94544 has informed FDA that it has transferred ownership
of, and all rights and interest in, ANADA 200-366 for NOVOCOX
(carprofen sodium) Caplets to Putney, Inc., One Monument Square, suite
400, Portland, ME 04101.
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
200-366.......................... NOVOCOX (carprofen 520.304
sodium) Caplets.
------------------------------------------------------------------------
Also, Pharmgate LLC, 161 North Franklin Turnpike, suite 2C, Ramsey,
NJ 07446, has informed FDA that it has changed its address to 1015
Ashes Dr., suite 102, Wilmington, NC 28405. Accordingly, 21 CFR 510.600
is being amended to reflect this change.
In addition, FDA is revising a human food safety warning for use of
sulfamethazine soluble powder in pre-ruminating calves. FDA is also
changing the drug labeler code for a generic dinoprost injection
product in 21 CFR 522.690, which in error was omitted from a final rule
changing sponsorship of an application (78 FR 17595, March 22, 2013).
Also, the strength of lufenuron injectable suspension is also being
amended to conform to the approved application. These technical
amendments are being made to improve the accuracy of the regulations.
In addition, Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 has
requested that FDA withdraw approval of NADA 046-666 that provides for
use of Type A medicated articles containing penicillin G procaine to
manufacture medicated feeds administered to poultry and swine. This
action is being taken at the sponsor's request because this product is
no longer manufactured or marketed. Note this NADA was identified 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. Elsewhere in this issue of
the Federal Register, FDA gave notice that approval of NADA 046-666,
and all supplements and amendments thereto, is withdrawn, effective
October 23, 2015. As provided in the regulatory text of this document,
the animal drug regulations are amended to reflect this voluntary
withdrawal of approval.
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, and 524
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
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, 524, 556, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 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), add an entry for
``Orkeo USA, Inc.'' in alphabetical order and revise the entry for
``Pharmgate LLC''; and in the table in paragraph (c)(2), revise the
entry for ``069254'' and add in numerical order an entry for ``086050''
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
------------------------------------------------------------------------
* * * * * * *
Orkeo USA, Inc., 77 Water St., New York, NY 10005....... 086050
* * * * * * *
Pharmgate LLC, 1015 Ashes Dr., Suite 102, Wilmington, NC 069254
28405..................................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
069254............................... Pharmgate LLC, 1015 Ashes Dr.,
Suite 102, Wilmington, NC 28405.
* * * * * * *
086050............................... Orkeo USA, Inc., 77 Water St.,
New York, NY 10005.
[[Page 61296]]
* * * * * * *
------------------------------------------------------------------------
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.304 [Amended]
0
4. In Sec. 520.304, in paragraph (b)(2), remove ``000115'' and in
numerical sequence add ``026637''.
0
5. In Sec. 520.2158, revise paragraphs (d)(1) and (2) and add
paragraph (d)(3) to read as follows:
Sec. 520.2158 Streptomycin.
* * * * *
(d) * * *
(1) Calves--(i) Amount. 10 to 15 milligrams per pound (mg/pound) of
body weight (1.0 to 1.5 grams per gallon) for up to 5 days.
(ii) Indications for use. For the treatment of bacterial enteritis
caused by Escherichia coli and Salmonella spp. susceptible to
streptomycin.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Swine--(i) Amount. 10 to 15 mg/pound of body weight (1.0 to 1.5
grams per gallon) for up to 4 days.
(ii) Indications for use. For the treatment of bacterial enteritis
caused by Escherichia coli and Salmonella spp. susceptible to
streptomycin.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(3) Chickens--(i) Amount. 10 to 15 mg/pound of body weight (0.6 to
0.9 grams per gallon) for up to 5 days.
(ii) Indications for use. For the treatment of nonspecific
infectious enteritis caused by organisms susceptible to streptomycin.
(iii) Limitations. Withdraw 4 days before slaughter. Do not
administer to chickens producing eggs for human consumption. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
0
6. In Sec. 520.2261b, in paragraph (d)(4)(iii), revise the last two
sentences to read as follows:
Sec. 520.2261b Sulfamethazine powder.
* * * * *
(d) * * *
(4) * * *
(iii) * * * Do not use in calves under one (1) month of age or
calves being fed an all-milk diet. Use in these classes of calves may
cause violative residues to remain beyond the withdrawal time.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
7. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
8. Amend Sec. 522.690 as follows:
0
a. Revise paragraphs (a), (b), and (c);
0
b. Redesignate paragraphs (d)(1) and (2) as paragraphs (d)(2) and (4),
respectively, and add new paragraph (d)(1);
0
c. In newly redesignated paragraph (d)(2)(ii) and in paragraph
(d)(3)(ii), revise the paragraph heading ``Indications'', to read
``Indications for use''; and
0
d. Revise newly redesignated paragraph (d)(4) introductory text.
The revisions and addition read as follows:
Sec. 522.690 Dinoprost.
(a) Specifications. Each milliliter (mL) of solution contains
dinoprost tromethamine equivalent to 5 milligrams (mg) or 12.5 mg
dinoprost.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
(1) No. 054771 for use of the 12.5 mg/mL product as in paragraph
(d)(1) of this section.
(2) Nos. 000859 and 054771 for use of the 5 mg/mL product as in
paragraphs (d)(2), (d)(3), and (d)(4) of this section.
(c) Special considerations. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
(d) * * *
(1) Cattle. Administer product described in paragraph (b)(1) of
this section as follows:
(i) Amount. 25 mg as a single intramuscular injection.
(ii) Indications for use. As a luteolytic agent; effective only in
those cattle having a corpus luteum, i.e., those which ovulated at
least 5 days prior to treatment.
(A) For estrus synchronization in beef cows, beef heifers and
replacement dairy heifers.
(B) For unobserved (silent) estrus in lactating dairy cows with a
corpus luteum.
(C) For treatment of pyometra (chronic endometritis) in cattle.
(D) For abortion in beef cows, beef heifers and replacement dairy
heifers.
(E) For use with gonadorelin injection as in Sec. 522.1077 of this
chapter to synchronize estrous cycles to allow fixed-time artificial
insemination (FTAI) in lactating dairy cows.
(F) For use with progesterone intravaginal inserts as in Sec.
529.1940 of this chapter for synchronization of estrus in lactating
dairy cows.
(G) For use with progesterone intravaginal inserts as in Sec.
529.1940 of this chapter for synchronization of estrus in suckled beef
cows and replacement beef and dairy heifers, advancement of first
postpartum estrus in suckled beef cows, and advancement of first
pubertal estrus in beef heifers.
* * * * *
(4) Cattle. Administer product described in paragraph (b)(2) of
this section as follows:
* * * * *
0
9. In Sec. 522.812, revise paragraph (b)(2) to read as follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(b) * * *
(2) No. 055529 for use of product described in paragraph (a)(1) of
this section as in paragraph (e)(1) of this section, and use of product
described in paragraph (a)(2) in this section as in paragraphs (e)(2),
(e)(3)(i)(B), and (e)(3)(ii) of this section.
* * * * *
0
10. In Sec. 522.955, revise paragraphs (a), (b), (d)(1) subject
heading, (d)(1)(i) introductory text, (d)(1)(i)(C), (d)(1)(ii)
introductory text, and (d)(1)(ii)(C) to read as follows:
Sec. 522.955 Florfenicol.
(a) Specifications. Each milliliter of solution contains:
(1) 300 milligrams (mg) florfenicol in the inactive vehicles 2-
pyrrolidone and triacetin.
(2) 300 mg florfenicol in the inactive vehicles n-methyl-2-
pyrrolidone, propylene glycol, and polyethylene glycol.
(3) 300 mg florfenicol in the inactive vehicles 2-pyrrolidone and
glycerol formal.
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter:
(1) No. 000061 for use of product described in paragraph (a)(1) as
in paragraph (d)(1)(i); and
(2) Nos. 000061 and 086050 for use of product described in
paragraph (a)(2) as in paragraph (d)(1)(ii).
[[Page 61297]]
(3) No. 055529 for use of product described in paragraph (a)(3) as
in paragraph (d)(1)(ii).
* * * * *
(d) * * *
(1) Beef and non-lactating dairy cattle--(i) 300 mg per milliliter
(mL) florfenicol in the inactive vehicles 2-pyrrolidone and triacetin:
* * * * *
(C) Limitations. Animals intended for human consumption must not be
slaughtered within 44 days of treatment. Do not use in female dairy
cattle 20 months of age or older. Use of florfenicol in this class of
cattle may cause milk residues. A withdrawal period has not been
established in pre-ruminating calves. Do not use in calves to be
processed for veal. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
(ii) 300 mg/mL florfenicol in the inactive vehicles n-methyl-2-
pyrrolidone, propylene glycol, and polyethylene glycol, or in 2-
pyrrolidone and glycerol formal:
(C) Limitations. Animals intended for human consumption must not be
slaughtered within 28 days of the last intramuscular treatment. Animals
intended for human consumption must not be slaughtered within 33 days
of subcutaneous treatment. This product is not approved for use in
female dairy cattle 20 months of age or older, including dry dairy
cows. Use in these cattle may cause drug residues in milk and/or in
calves born to these cows. A withdrawal period has not been established
in pre-ruminating calves. Do not use in calves to be processed for
veal. Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
* * * * *
Sec. 522.1289 [Amended]
0
11. In Sec. 522.1289, in paragraph (a),, remove ``10 milligrams'' and
in its place add ``100 milligrams''.
0
12. Add Sec. 522.2075 to read as follows:
Sec. 522.2075 Robenacoxib.
(a) Specifications. Each milliliter of solution contains 20
milligrams (mg) robenacoxib.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in cats--(1) Amount. Administer 0.91 mg per
pound (2 mg/kilogram) by subcutaneous injection, once daily, for a
maximum of 3 days.
(2) Indications for use. For the control of postoperative pain and
inflammation associated with orthopedic surgery, ovariohysterectomy,
and castration in cats at least 4 months of age for a maximum of 3
days.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
13. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
14. In Sec. 524.154, revise paragraphs (a)(1) and (2) and (b)(2) to
read as follows:
Sec. 524.154 Bacitracin, neomycin, and polymyxin B ophthalmic
ointment.
(a) * * *
(1) 500 units bacitracin, 3.5 milligrams (mg) neomycin sulfate
(equivalent to 3.5 mg neomycin base), and 10,000 units polymyxin B
sulfate; or
(2) 400 units bacitracin zinc, 5 mg neomycin sulfate (equivalent to
3.5 mg neomycin base), and 10,000 units polymyxin B sulfate.
(b) * * *
(2) Nos. 000061, 043264, and 059399 for use of product described in
paragraph (a)(2) as in paragraph (c) of this section.
* * * * *
0
15. In Sec. 524.1484g, revise paragraphs (a) and (b) to read as
follows:
Sec. 524.1484g Neomycin, thiabendazole, and dexamethasone solution.
(a) Specifications. Each milliliter of solution contains 40
milligrams (mg) thiabendazole, 3.2 mg neomycin (from neomycin sulfate),
and 1 mg dexamethasone.
(b) Sponsors. See Nos. 026637 and 050604 in Sec. 510.600(c) of
this chapter.
* * * * *
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
16. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
17. Add Sec. 556.68 to read as follows:
Sec. 556.68 Avilamycin.
(a) Acceptable Daily Intake (ADI). The ADI for total residues of
avilamycin is 1.1 milligram per kilogram of body weight per day.
(b) Tolerances. A tolerance for avilamycin is not required.
(c) Related conditions of use. See Sec. 558.68 of this chapter.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
18. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
19. In Sec. 558.4, in paragraph (d), in the ``Category I'' table, add
an entry in alphabetical order for ``Avilamycin'' to read as follows:
Sec. 558.4 Requirement of a medicated feed mill license.
* * * * *
(d) * * *
Category I
----------------------------------------------------------------------------------------------------------------
Assay limits Assay limits
Drug percent \1\ Type B maximum (200x) percent Type B/
Type A C
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Avilamycin................................... 90-110 3.65 g/lb (0.8%)............... 80-110
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
20. Add Sec. 558.68 to read as follows:
Sec. 558.68 Avilamycin.
(a) Specifications. Each pound of Type A medicated article contains
90.7 grams of avilamycin.
(b) Sponsor. See No. 000986 in Sec. 510.600(c) of this chapter.
(c) Special considerations--(1) Federal law restricts avilamycin
[[Page 61298]]
medicated feeds to use under a veterinary feed directive (VFD) and the
professional supervision of a licensed veterinarian. See Sec. 558.6 of
this chapter for additional requirements.
(2) The expiration date of VFDs for avilamycin medicated feeds must
not exceed 90 days from the date of issuance. VFDs for avilamycin shall
not be refilled.
(d) Related tolerances. See Sec. 556.68 of this chapter.
(e) Conditions of use in swine--(1) Amount. Feed at 73 grams
avilamycin per ton of Type C medicated feed (80 ppm) as the sole ration
for 21 consecutive days. The veterinarian may direct feeding for up to
a total of 42 consecutive days, based on the clinical assessment.
(2) Indications for use. Weaned pigs less than 14 weeks of age: For
the reduction in incidence and overall severity of diarrhea in the
presence of pathogenic Escherichia coli in groups of weaned pigs.
(3) Limitations. Feed continuously as the sole ration.
Sec. 558.460 [Amended]
0
21. In Sec. 558.460, revise paragraphs (a) and (b) to read as follows:
Sec. 558.460 Penicillin.
(a) Specifications. Type A medicated articles containing 100 or 227
grams penicillin procaine G or feed grade penicillin procaine per
pound.
(b) Sponsor: See No. 066104 in Sec. 510.600(c) of this chapter.
* * * * *
Sec. 558.500 [Amended]
0
22. Amend Sec. 558.500 as follows:
0
a. In paragraphs (e)(1)(ii), (iii), and (iv), in the ``Limitations''
column, remove the last sentence and in its place add ``Ractopamine as
provided by Nos. 000986 or 054771; tylosin as provided by Nos. 000986
or 016592 in Sec. 510.600(c) of this chapter.''.
0
b. In paragraphs (e)(2)(iv), (ix), and (xiii), in the ``Limitations''
column, remove the last sentence and in its place add ``Ractopamine as
provided by Nos. 000986 or 054771 with monensin as provided by No.
000986, and tylosin as provided by Nos. 000986 or 016592 in Sec.
510.600(c) of this chapter.''.
0
c. In paragraph (e)(2)(x), in the ``Limitations'' column, to the last
sentence add ``; or ractopamine as provided by No. 054771 with monensin
as provided by No. 000986, tylosin provided by No. 016592, and
melengestrol acetate provided by No. 054771 in Sec. 510.600(c) of this
chapter.''
Sec. 558.618 [Amended]
0
23. In Sec. 558.618, in paragraph (e)(2)(i), in the ``Sponsor''
column, add ``016592'' after ``000986''.
Dated: October 6, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-25918 Filed 10-9-15; 8:45 am]
BILLING CODE 4164-01-P
