New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor's Name and Address; Change of Sponsor's Address, 59131-59135 [2016-19914]
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Federal Register / Vol. 81, No. 167 / Monday, August 29, 2016 / Rules and Regulations
§ 101.2 [Amended]
PART 1—GENERAL ENFORCEMENT
REGULATIONS
1. The authority citation for part 1
continues to read as follows:
Authority: 15 U.S.C. 1333, 1453, 1454,
1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C.
321, 331, 332, 333, 334, 335a, 342i, 343,
350c, 350d, 350e, 352, 355, 360b, 360ccc,
360ccc–1, 360ccc–2, 362, 371, 373, 374, 381,
382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241,
243, 262, 264.
§ 1.1 [Amended]
[Amended]
§ 101.7 Declaration of net quantity of
contents.
*
*
§ 101.13
*
*
[Amended]
11. Amend paragraphs (d)(2), (h)(4)(i),
and (i)(2) by removing ‘‘§ 101.105(i)’’
and adding in its place ‘‘§ 101.7(i)’’.
■
§ 101.30
[Amended]
12. Amend § 101.30(g) by removing
‘‘§ 101.105(i)’’ and adding in its place
‘‘§ 101.7(i)’’.
■
PART 104—NUTRITIONAL QUALITY
GUIDELINES FOR FOODS
3. In § 1.20, by removing
‘‘§ 101.105(f)’’ and adding in its place
‘‘§ 101.7(f)’’.
■
§ 1.24
[Redesignated as § 101.7]
9. Redesignate § 101.105 as § 101.7.
10. Revise newly designated § 101.7
section heading to read as follows:
■
■
*
2. Amend § 1.1(c) as follows:
a. Remove ‘‘101.105(f)’’ and add in its
place ‘‘101.7(f)’’.
■ b. Remove ‘‘101.105(i)’’ and add in its
place ‘‘101.7(i)’’.
■ c. Remove ‘‘101.105(j)’’ and add in its
place ‘‘101.7(j)’’.
■ d. Remove ‘‘101.105(o)’’ and add in its
place ‘‘101.7(o)’’.
■
■
§ 1.20
§ 101.105
13. The authority citation for part 104
continues to read as follows:
■
[Amended]
Authority: 21 U.S.C. 321, 343, 371(a).
4. Amend § 1.24 as follows:
a. Remove ‘‘§ 101.105’’ in paragraph
(a)(2) and add in its place ‘‘§ 101.7’’.
■ b. Remove ‘‘§ 101.105(b)(2)’’ wherever
it appears and add in its place
‘‘§ 101.7(b)(2)’’.
■ c. Remove ‘‘§ 101.105(f)’’ wherever it
appears and add in its place
‘‘§ 101.7(f)’’.
■ d. Remove ‘‘§ 101.105(j)’’ wherever it
appears and add in its place
‘‘§ 101.7(j)’’.
■ e. Remove ‘‘§ 101.105(j)(1)’’ wherever
it appears and add in its place
‘‘§ 101.7(j)(1)’’.
§ 104.5
PART 100—GENERAL
Food and Drug Administration
■
5. The authority citation for part 100
continues to read as follows:
21 CFR Parts 510, 520, 522, 524, and
558
Authority: 21 U.S.C. 321, 331, 337, 342,
343, 348, 371.
[Docket No. FDA–2016–N–0002]
■
■
§ 100.155
[Amended]
6. Amend § 100.155 in paragraphs (a)
and (b) by removing ‘‘§ 101.105’’ and
adding in its place ‘‘§ 101.7’’.
■
PART 101—FOOD LABELING
7. The authority citation for part 101
continues to read as follows:
jstallworth on DSK7TPTVN1PROD with RULES
■
14:52 Aug 26, 2016
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14. Amend § 104.5(b) by removing
‘‘§ 101.105’’ and adding in its place
‘‘§ 101.7’’.
■
Dated: August 16, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2016–19925 Filed 8–26–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
New Animal Drugs; Approval of New
Animal Drug Applications; Withdrawal
of Approval of New Animal Drug
Applications; Changes of
Sponsorship; Change of Sponsor’s
Name and Address; Change of
Sponsor’s Address
Food and Drug Administration,
HHS.
Authority: 15 U.S.C. 1453, 1454, 1455; 21
U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C.
243, 264, 271.
VerDate Sep<11>2014
[Amended]
AGENCY:
Final rule; technical
amendment.
ACTION:
PO 00000
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Fmt 4700
The Food and Drug
Administration (FDA or we) 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 May and
June 2016. 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 changes of sponsorship of
applications, changes of sponsors’
names and addresses, and the voluntary
withdrawals of approval of applications.
DATES: This rule is effective August 29,
2016, except for the amendments to 21
CFR 558.274, 58.355, 58.363, 58.550,
558.625, and 558.630, which are
effective September 8, 2016.
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.
SUMMARY:
8. Amend § 101.2 in paragraph (c)
introductory text by removing
‘‘§ 101.105(h)(1)’’ and adding in its
place ‘‘§ 101.7(h)(1)’’.
■
■
59131
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SUPPLEMENTARY INFORMATION:
I. Approval Actions
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs and ANADAs during May
and June 2016, 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/ApprovedAnimalDrug
Products/default.htm.
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Federal Register / Vol. 81, No. 167 / Monday, August 29, 2016 / Rules and Regulations
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MAY AND JUNE 2016
Approval date
Sponsor
File No.
Product name
Species
Indications for use/effect
of the action
Public
documents
Original approval for the prevention of mortality caused
by necrotic enteritis associated
with
Clostridium
perfringens in broiler chickens.
Original approval for appetite
stimulation in dogs.
FOI Summary,
EA/FONSI.1
Original approval for the control of postoperative pain
and inflammation associated
with soft tissue surgery in
dogs.
Original approval of a generic
copy of NADA 141–177.
FOI Summary.
Original approval for use in
two-way, combination drug
Type B and Type C medicated feeds for cattle fed in
confinement for slaughter.
Original approval as a generic
copy of NADA 110–399.
FOI Summary.
May 2, 2016 ..........
141–439
Elanco Animal Health, A Division of Eli Lilly & Co., Lilly
Corporate Center, Indianapolis, IN 46285.
INTEPRITY (avilamycin) Type
A medicated article.
Chickens ....
May 16, 2016 ........
141–457
ENTYCE (capromorelin
solution).
oral
Dogs ...........
May 17, 2016 ........
141–463
Aratana Therapeutics, Inc.,
11400 Tomahawk Creek
Pkwy., Leawood, KS 66211.
Elanco US, Inc., 2500 Innovation Way, Greenfield, IN
46140.
ONSIOR (robenacoxib) Tablets
for Dogs.
Dogs ...........
May 17, 2016 ........
200–536
Med-Pharmex,
Inc.,
2727
Thompson Creek Rd., Pomona, CA 91767–1861.
Dogs ...........
May 24, 2016 ........
200–596
Huvepharma EOOD, 5th Floor,
3A Nikolay Haytov Str., 1113
Sophia, Bulgaria.
MOMETAVET (gentamicin sulfate,
USP;
mometasone
furoate anhydrous, USP; and
clotrimazole, USP) Otic Suspension.
TILMOVET 90 (tilmicosin phosphate) and RUMENSIN 90
(monensin) Type A medicated articles.
June 20, 2016 .......
200–587
Cross Vetpharm Group Ltd.
Broomhill Rd., Tallaght, Dublin 24, Ireland.
FERROFORTE
injection).
Piglets ........
(gleptoferron
Cattle ..........
FOI Summary.
FOI Summary.
FOI Summary.
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).
II. Changes of Sponsorship
Bayer HealthCare LLC, Animal Health
Division, P.O. Box 390, Shawnee,
Mission, KS 66201 has informed FDA
that it has transferred ownership of, and
all rights and interest in, the following
File No.
200–228
200–254
200–256
200–351
200–389
approved applications to Huvepharma
EOOD, 5th Floor, 3A Nikolay Haitov
Str., 1113 Sofia, Bulgaria:
21 CFR
section
Product name
PHOENECTIN (ivermectin) Injectable Solution ..............................................................................................................
Iron Dextran Injection, 100 mg/mL ..................................................................................................................................
Iron Dextran Injection, 200 mg/mL ..................................................................................................................................
Lincomycin Injectable, USP ............................................................................................................................................
Amprolium 9.6% Oral Solution ........................................................................................................................................
As provided in the regulatory text of
this document, the animal drug
regulations are amended to reflect these
changes of sponsorship.
III. Withdrawals of Approval
In addition, during May and June
2016, Elanco US, Inc., 2500 Innovation
Way, Greenfield, IN 46140 requested
that FDA withdraw approval of the
NADAs listed in the following table
because the products are no longer
manufactured or marketed:
21 CFR
section
File No.
Product name
012–548 1
013–162 1
013–388 1
015–166 1
127–507 1
141–164 1
141–170 1
141–198 1
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522.1192
522.1182
522.1182
522.1260
520.100
TYLOSIN (tylosin phosphate)/HYGROMIX (hygromycin B) ...........................................................................................
TYLAN TM (tylosin phosphate) Type A medicated article ..............................................................................................
TYLAN (tylosin phosphate)/HYGROMIX (hygromycin B) Premix ...................................................................................
TYLAN TM (tylosin phosphate) Type A medicated article ..............................................................................................
TYLAN 5, 10, 20, or 40 SULFA-G (tylosin phosphate and sulfamethazine) ..................................................................
TYLAN (tylosin phosphate)/COBAN (monensin) ............................................................................................................
TYLAN (tylosin phosphate)/MONTEBAN (narasin) .........................................................................................................
TYLAN TM (tylosin phosphate)/BIO-COX (salinomycin) ................................................................................................
558.274
558.625
558.274
558.625
558.630
558.355
558.363
558.550
1 These NADAs were 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.
Elsewhere in this issue of the Federal
Register, FDA gave notice that approval
of NADAs 012–548, 013–162, 013–388,
015–166, 127–507, 141–640, 141–170,
and 141–198, and all supplements and
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amendments thereto, is withdrawn,
effective September 8, 2016. As
provided in the regulatory text of this
document, the animal drug regulations
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are amended to reflect these voluntary
withdrawals of approval.
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Federal Register / Vol. 81, No. 167 / Monday, August 29, 2016 / Rules and Regulations
IV. Technical Amendments
FDA has noticed that a drug labeler
code in 21 CFR 520.2325a does not
accurately reflect the sponsorship of a
new animal drug application. At this
time, we are amending this section. This
action is being taken to improve the
accuracy of the regulations.
Also, ConAgra Pet Products Co., 3902
Leavenworth St., Omaha, NE 68105 has
informed FDA that it is changing its
name and address to Sergeant’s Pet Care
Products, Inc., 10077 S. 134th St.,
Omaha, NE 68138.
Alexion Pharmaceuticals, Inc., 33
Hayden Ave., Lexington, MA 02421 has
informed FDA that it has changed its
address to 100 College St., New Haven,
CT 06510. At this time, this firm is
being added to the list of sponsors of
approved application in 21 CFR
510.600(c) which we had not done
previously.
FDA has noticed that the maximum
concentration of sulfadimethoxine with
ormetoprim in 2-way, fixed-ratio
combination drug Type B medicated
feeds in 21 CFR 558.4 was amended in
error. At this time, we are revising this
section to provide for appropriate
concentrations in Type B medicated
feeds for salmonids and catfish. This
action is being taken 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.
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 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, 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), alphabetically add an
entry for ‘‘Alexion Pharmaceuticals,
Inc.’’, remove the entry for ‘‘ConAgra
Pet Products Co.’’, and alphabetically
add an entry for ‘‘Sergeant’s Pet Care
Products, Inc.’’; and in the table in
paragraph (c)(2), revise the entry for
‘‘021091’’ and numerically add an entry
for ‘‘069334’’.
The additions and revisions read as
follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Drug labeler
code
Firm name and address
*
*
*
*
*
*
Alexion Pharmaceuticals, Inc., 100 College St., New Haven, CT 06510 ...........................................................................................
*
*
*
*
*
*
*
Sergeant’s Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138 ....................................................................................
*
*
*
*
*
*
069334
021091
*
*
(2) * * *
Drug labeler
code
Firm name and address
*
021091 ...........
*
*
*
*
Sergeant’s Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138.
*
*
*
069334 ...........
*
*
*
Alexion Pharmaceuticals, Inc., 100 College St., New Haven, CT 06510.
*
*
*
*
*
*
*
*
*
*
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
§§ 520.300, 520.300a, 520.300b, and
520.300c [Redesignated as §§ 520.284,
520.284a, 520.284b, and 520.284c.]
3. The authority citation for part 520
continues to read as follows:
■
jstallworth on DSK7TPTVN1PROD with RULES
■
Authority: 21 U.S.C. 360b.
§ 520.100
[Amended]
§ 520.292
4. In § 520.100, remove paragraphs
(b)(3) and (4).
■
VerDate Sep<11>2014
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5. Redesignate §§ 520.300, 520.300a,
520.300b, and 520.300c as §§ 520.284,
520.284a, 520.284b, and 520.284c.
■ 6. Add § 520.292 to read as follows:
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Capromorelin.
(a) Specifications. Each milliliter of
solution contains 30 milligrams (mg)
capromorelin.
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(b) Sponsor. See No. 086026 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer 3 mg/kg once daily
by mouth.
(2) Indications for use. For appetite
stimulation in dogs.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 7. In § 520.2075, revise paragraphs (a)
and (c) to read as follows:
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§ 520.2075
Robenacoxib.
§ 522.1055
(a) Specifications. Each tablet
contains 10, 20, or 40 milligrams (mg)
robenacoxib for use in dogs, or 6 mg
robenacoxib for use in cats.
*
*
*
*
*
(c) Conditions of use—(1) Dogs—(i)
Amount. Administer 0.91 mg/lb (2 mg/
kg) orally, once daily, for a maximum of
3 days.
(ii) Indications for use. For the control
of postoperative pain and inflammation
associated with soft tissue surgery in
dogs weighing at least 5.5 lb (2.5 kg) and
at least 4 months of age for a maximum
of 3 days.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) Cats—(i) Amount. Administer 0.45
mg/lb (1 mg/kg) orally, once daily, for
a maximum of 3 days.
(ii) Indications for use. For the control
of postoperative pain and inflammation
associated with orthopedic surgery,
ovariohysterectomy, and castration in
cats weighing at least 5.5 lb (2.5 kg) and
at least 4 months of age for a maximum
of 3 days.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 520.2325a
[Amended]
8. In § 520.2325a, in paragraph (a)(3),
remove ‘‘053501’’ and in its place add
‘‘054771’’.
■
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
9. The authority citation for part 522
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
Gleptoferron.
§ 522.1182
[Amended]
11. In § 522.1182, in paragraph (b)
introductory text, remove ‘‘baby pigs’’
and in its place add ‘‘young piglets’’; in
paragraph (b)(7) introductory text,
remove ‘‘000859’’ and in its place add
‘‘016592’’; and in paragraphs (b)(7)(i)
and (ii), remove ‘‘baby pig’’.
■
§ 522.1192
[Amended]
12. In § 522.1192, in paragraph (b)(2),
remove ‘‘000859’’ and in its place add
‘‘016592,’’.
■
§ 522.1260
[Amended]
13. In § 522.1260, in paragraph (b)(2),
remove ‘‘000859’’ and in its place add
‘‘016592’’.
■
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
14. The authority citation for part 524
continues to read as follows:
■
10. Revise § 522.1055 to read as
follows:
■
15. In § 524.1044h, revise paragraphs
(a) and (b) to read as follows:
■
(a) Specifications. Each milliliter (mL)
contains the equivalent of 200
milligrams of elemental iron as
gleptoferron, a complex of ferric
hydroxide and dextran glucoheptonic
acid.
(b) Sponsors. See Nos. 059120 and
061623 in § 510.600(c) of this chapter.
(c) Conditions of use in swine—(1)
Indications for use and amounts—(i)
Prevention of anemia due to iron
deficiency: Administer 1 mL (200 mg
iron) per pig by intramuscular injection
on or before 3 days of age.
(ii) Treatment of anemia due to iron
deficiency: Administer 1 mL (200 mg
iron) per pig by intramuscular injection
as soon as signs of deficiency appear.
(2) [Reserved]
Authority: 21 U.S.C. 360b.
§ 524.1044h Gentamicin, mometasone, and
clotrimazole otic suspension.
(a) Specifications. Each gram of
suspension contains gentamicin sulfate,
United States Pharmacopeia (USP)
equivalent to 3 milligram (mg)
gentamicin base, mometasone furoate
monohydrate or mometasone furoate
anhydrous, USP, equivalent to 1 mg
mometasone, and 10 mg clotrimazole,
USP.
(b) Sponsors. See Nos. 000061 and
054925 in § 510.600(c) of this chapter.
*
*
*
*
*
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
16. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
§ 558.4
[Amended]
17. In § 558.4, in paragraph (d), in the
‘‘Category I’’ table, in the ‘‘Type B
maximum (200 ×)’’ column, in the row
entry for ‘‘Avilamycin’’, remove ‘‘3.65 g/
lb (0.8%)’’ and in its place add ‘‘7.3 g/
lb (1.6%)’’; and in the ‘‘Category II’’
table, remove the row entry for
‘‘Sulfadimethoxine’’ and two following
row entries for ‘‘Ormetoprim’’, and in
their place add row entries for
‘‘Sulfadimethoxine’’ and ‘‘Ormetoprim’’.
The additions read as follows:
■
§ 558.4 Requirement of a medicated feed
mill license.
*
*
*
(d) * * *
*
*
CATEGORY II
Assay limits
percent 1
Type A
Drug
*
*
*
Sulfadimethoxine ....................................................
90–110
Ormetoprim .............................................................
90–110
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*
*
*
*
*
*
*
■ 18. In § 558.68, revise paragraphs (a)
and (e) to read as follows:
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*
*
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*
*
Poultry: 5.675 g/lb ..................................................
Fish: 85.1 g/lb .........................................................
Poultry: 3.405 g/lb ..................................................
Fish: 17.0 g/lb .........................................................
*
§ 558.68
*
Avilamycin.
(a) Each pound of Type A medicated
article contains 45.4 or 90.7 grams of
avilamycin.
*
*
*
*
*
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Assay limits
percent
Type B/C
Type B maximum
(100 ×)
Fmt 4700
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*
*
80–115/75–125
80–115
*
(e) Conditions of use. Administer in
feed as follows:
(1) Chickens—
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Avilamycin in
grams/ton
Combination in
grams/ton
Indications for use
Limitations
(i) 13.6 to 40.9 ..............
........................
Broiler chickens: For the prevention of
mortality caused by necrotic enteritis
associated
with
Clostridium
perfringens in broiler chickens.
Feed as the sole ration for 21 consecutive days. To assure responsible antimicrobial drug use in broiler chickens,
treatment administration must begin
on or before 10 days of age.
Avilamycin in
grams/ton
Combinationin
grams/ton
Indications for use
Limitations
(i) 73 .............................
........................
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.
Feed as the sole ration for 21 consecutive days. To assure responsible antimicrobial drug use in pigs, do not administer to pigs 14 weeks of age or
older.
Sponsor
000986
(ii) [Reserved].
(2) Swine—
Sponsor
000986
(ii) [Reserved].
§ 558.274
[Amended]
24. Effective September 8, 2016, in
§ 558.625, revise paragraphs (b)(1),
(f)(2)(i), (f)(2)(iii), and (f)(2)(vii) and
remove paragraphs (f)(2)(viii) and (ix).
The revisions read as follows:
■
19. Effective September 8, 2016, in
§ 558.274, remove and reserve
paragraphs (c)(1)(ii) and (c)(2)(ii).
■ 20. Effective September 8, 2016, in
§ 558.355, remove and reserve
paragraph (f)(1)(xxviii) and revise
paragraphs (f)(8)(i) and (ii).
The revisions read as follows:
■
§ 558.355
§ 558.625
*
*
*
*
*
(f) * * *
(8) * * *
(i) Decoquinate alone and in
combination as in § 558.195.
(ii) Melengestrol acetate alone and in
combination as in § 558.342.
*
*
*
*
*
§ 558.363
[Amended]
21. Effective September 8, 2016, in
§ 558.363, remove and reserve
paragraph (d)(1)(vi).
■
§ 558.550
[Amended]
22. Effective September 8, 2016, in
§ 558.550, remove and reserve
paragraph (d)(1)(xxii).
■
§ 558.618
jstallworth on DSK7TPTVN1PROD with RULES
Tylosin and sulfamethazine.
*
[Amended]
23. In § 558.618, in paragraphs
(e)(2)(ii) and (iii):
■ a. In the ‘‘Limitations’’ column, add
‘‘Tilmicosin as provided by Nos. 000986
or 016952; monensin as provided by No.
000986 in § 510.600(c) of this chapter.’’
to the end of the existing entries; and
■ b. In the ‘‘Sponsor’’ column,
numerically add ‘‘016952’’.
■
*
*
*
*
(b) * * *
(1) No. 000986: 40 and 100 grams per
pound for use as in paragraph (f) of this
section.
*
*
*
*
*
(f) * * *
(2) * * *
(i) Decoquinate alone and in
combination as in § 558.195.
*
*
*
*
*
(iii) Melengestrol acetate alone and in
combination as in § 558.342.
*
*
*
*
*
(vii) Zilpaterol alone and in
combination as in § 558.665.
■ 25. Effective September 8, 2016, in
§ 558.630, revise paragraph (b)(1) to read
as follows:
§ 558.630
Food and Drug Administration
21 CFR Part 558
Tylosin.
*
Monensin.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
*
*
*
*
(b) * * *
(1) No. 000986: 40 and 100 grams per
pound for use as in paragraph (e) of this
section.
*
*
*
*
*
Dated: August 8, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. 2016–19914 Filed 8–26–16; 8:45 am]
BILLING CODE 4164–01–P
[Docket No. FDA–2016–N–0002]
New Animal Drugs for Use in Animal
Feed; Withdrawal of Approval of a New
Animal Drug Application
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of eight new animal drug
applications (NADAs) at the sponsor’s
request because these products are no
longer manufactured or marketed.
DATES: Withdrawal of approval is
effective September 8, 2016.
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: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285 has requested
that FDA withdraw approval of the
NADAs listed in the following table
because the products are no longer
manufactured or marketed:
SUMMARY:
21 CFR
section
File No.
Product name
012–548 1
013–162 1
TYLOSIN (tylosin phosphate)/HYGROMIX (hygromycin B) ...........................................................................................
TYLAN TM (tylosin phosphate) Type A medicated article ..............................................................................................
VerDate Sep<11>2014
14:52 Aug 26, 2016
Jkt 238001
PO 00000
Frm 00007
Fmt 4700
Sfmt 4700
E:\FR\FM\29AUR1.SGM
29AUR1
558.274
558.625
]]>Agencies
[Federal Register Volume 81, Number 167 (Monday, August 29, 2016)]
[Rules and Regulations]
[Pages 59131-59135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19914]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and 558
[Docket No. FDA-2016-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications; Changes of
Sponsorship; Change of Sponsor's Name and Address; Change of Sponsor's
Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) 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 May and June 2016. 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 changes of
sponsorship of applications, changes of sponsors' names and addresses,
and the voluntary withdrawals of approval of applications.
DATES: This rule is effective August 29, 2016, except for the
amendments to 21 CFR 558.274, 58.355, 58.363, 58.550, 558.625, and
558.630, which are effective September 8, 2016.
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:
I. Approval Actions
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during May and June 2016, 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 59132]]
Table 1--Original and Supplemental NADAs and ANADAs Approved During May and June 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
Indications for use/
Approval date File No. Sponsor Product name Species effect of the action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
May 2, 2016................ 141-439 Elanco Animal Health, INTEPRITY Chickens........... Original approval for FOI Summary, EA/
A Division of Eli (avilamycin) Type A the prevention of FONSI.\1\
Lilly & Co., Lilly medicated article. mortality caused by
Corporate Center, necrotic enteritis
Indianapolis, IN associated with
46285. Clostridium
perfringens in
broiler chickens.
May 16, 2016............... 141-457 Aratana Therapeutics, ENTYCE (capromorelin Dogs............... Original approval for FOI Summary.
Inc., 11400 Tomahawk oral solution). appetite stimulation
Creek Pkwy., in dogs.
Leawood, KS 66211.
May 17, 2016............... 141-463 Elanco US, Inc., 2500 ONSIOR (robenacoxib) Dogs............... Original approval for FOI Summary.
Innovation Way, Tablets for Dogs. the control of
Greenfield, IN 46140. postoperative pain
and inflammation
associated with soft
tissue surgery in
dogs.
May 17, 2016............... 200-536 Med-Pharmex, Inc., MOMETAVET (gentamicin Dogs............... Original approval of FOI Summary.
2727 Thompson Creek sulfate, USP; a generic copy of
Rd., Pomona, CA mometasone furoate NADA 141-177.
91767-1861. anhydrous, USP; and
clotrimazole, USP)
Otic Suspension.
May 24, 2016............... 200-596 Huvepharma EOOD, 5th TILMOVET 90 Cattle............. Original approval for FOI Summary.
Floor, 3A Nikolay (tilmicosin use in two-way,
Haytov Str., 1113 phosphate) and combination drug
Sophia, Bulgaria. RUMENSIN 90 Type B and Type C
(monensin) Type A medicated feeds for
medicated articles. cattle fed in
confinement for
slaughter.
June 20, 2016.............. 200-587 Cross Vetpharm Group FERROFORTE Piglets............ Original approval as FOI Summary.
Ltd. Broomhill Rd., (gleptoferron a generic copy of
Tallaght, Dublin 24, injection). NADA 110-399.
Ireland.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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).
II. Changes of Sponsorship
Bayer HealthCare LLC, Animal Health Division, P.O. Box 390,
Shawnee, Mission, KS 66201 has informed FDA that it has transferred
ownership of, and all rights and interest in, the following approved
applications to Huvepharma EOOD, 5th Floor, 3A Nikolay Haitov Str.,
1113 Sofia, Bulgaria:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
200-228................ PHOENECTIN (ivermectin) 522.1192
Injectable Solution.
200-254................ Iron Dextran Injection, 100 mg/ 522.1182
mL.
200-256................ Iron Dextran Injection, 200 mg/ 522.1182
mL.
200-351................ Lincomycin Injectable, USP..... 522.1260
200-389................ Amprolium 9.6% Oral Solution... 520.100
------------------------------------------------------------------------
As provided in the regulatory text of this document, the animal
drug regulations are amended to reflect these changes of sponsorship.
III. Withdrawals of Approval
In addition, during May and June 2016, Elanco US, Inc., 2500
Innovation Way, Greenfield, IN 46140 requested that FDA withdraw
approval of the NADAs listed in the following table because the
products are no longer manufactured or marketed:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
012-548 \1\............ TYLOSIN (tylosin phosphate)/ 558.274
HYGROMIX (hygromycin B).
013-162 \1\............ TYLAN TM (tylosin phosphate) 558.625
Type A medicated article.
013-388 \1\............ TYLAN (tylosin phosphate)/ 558.274
HYGROMIX (hygromycin B) Premix.
015-166 \1\............ TYLAN TM (tylosin phosphate) 558.625
Type A medicated article.
127-507 \1\............ TYLAN 5, 10, 20, or 40 SULFA-G 558.630
(tylosin phosphate and
sulfamethazine).
141-164 \1\............ TYLAN (tylosin phosphate)/COBAN 558.355
(monensin).
141-170 \1\............ TYLAN (tylosin phosphate)/ 558.363
MONTEBAN (narasin).
141-198 \1\............ TYLAN TM (tylosin phosphate)/ 558.550
BIO-COX (salinomycin).
------------------------------------------------------------------------
\1\ These NADAs were 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.
Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADAs 012-548, 013-162, 013-388, 015-166, 127-507,
141-640, 141-170, and 141-198, and all supplements and amendments
thereto, is withdrawn, effective September 8, 2016. As provided in the
regulatory text of this document, the animal drug regulations are
amended to reflect these voluntary withdrawals of approval.
[[Page 59133]]
IV. Technical Amendments
FDA has noticed that a drug labeler code in 21 CFR 520.2325a does
not accurately reflect the sponsorship of a new animal drug
application. At this time, we are amending this section. This action is
being taken to improve the accuracy of the regulations.
Also, ConAgra Pet Products Co., 3902 Leavenworth St., Omaha, NE
68105 has informed FDA that it is changing its name and address to
Sergeant's Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE
68138.
Alexion Pharmaceuticals, Inc., 33 Hayden Ave., Lexington, MA 02421
has informed FDA that it has changed its address to 100 College St.,
New Haven, CT 06510. At this time, this firm is being added to the list
of sponsors of approved application in 21 CFR 510.600(c) which we had
not done previously.
FDA has noticed that the maximum concentration of sulfadimethoxine
with ormetoprim in 2-way, fixed-ratio combination drug Type B medicated
feeds in 21 CFR 558.4 was amended in error. At this time, we are
revising this section to provide for appropriate concentrations in Type
B medicated feeds for salmonids and catfish. This action is being taken
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.
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 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, 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), alphabetically
add an entry for ``Alexion Pharmaceuticals, Inc.'', remove the entry
for ``ConAgra Pet Products Co.'', and alphabetically add an entry for
``Sergeant's Pet Care Products, Inc.''; and in the table in paragraph
(c)(2), revise the entry for ``021091'' and numerically add an entry
for ``069334''.
The additions and revisions 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
------------------------------------------------------------------------
* * * * * * *
Alexion Pharmaceuticals, Inc., 100 College St., New 069334
Haven, CT 06510........................................
* * * * * * *
Sergeant's Pet Care Products, Inc., 10077 S. 134th St., 021091
Omaha, NE 68138........................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
021091.......................... Sergeant's Pet Care Products, Inc.,
10077 S. 134th St., Omaha, NE 68138.
* * * * * * *
069334.......................... Alexion Pharmaceuticals, Inc., 100
College St., New Haven, CT 06510.
* * * * * * *
------------------------------------------------------------------------
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. 520.100 [Amended]
0
4. In Sec. 520.100, remove paragraphs (b)(3) and (4).
Sec. Sec. 520.300, 520.300a, 520.300b, and 520.300c [Redesignated as
Sec. Sec. 520.284, 520.284a, 520.284b, and 520.284c.]
0
5. Redesignate Sec. Sec. 520.300, 520.300a, 520.300b, and 520.300c as
Sec. Sec. 520.284, 520.284a, 520.284b, and 520.284c.
0
6. Add Sec. 520.292 to read as follows:
Sec. 520.292 Capromorelin.
(a) Specifications. Each milliliter of solution contains 30
milligrams (mg) capromorelin.
(b) Sponsor. See No. 086026 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer 3 mg/kg once
daily by mouth.
(2) Indications for use. For appetite stimulation in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
7. In Sec. 520.2075, revise paragraphs (a) and (c) to read as follows:
[[Page 59134]]
Sec. 520.2075 Robenacoxib.
(a) Specifications. Each tablet contains 10, 20, or 40 milligrams
(mg) robenacoxib for use in dogs, or 6 mg robenacoxib for use in cats.
* * * * *
(c) Conditions of use--(1) Dogs--(i) Amount. Administer 0.91 mg/lb
(2 mg/kg) orally, once daily, for a maximum of 3 days.
(ii) Indications for use. For the control of postoperative pain and
inflammation associated with soft tissue surgery in dogs weighing at
least 5.5 lb (2.5 kg) and at least 4 months of age for a maximum of 3
days.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Cats--(i) Amount. Administer 0.45 mg/lb (1 mg/kg) orally, once
daily, for a maximum of 3 days.
(ii) Indications for use. For the control of postoperative pain and
inflammation associated with orthopedic surgery, ovariohysterectomy,
and castration in cats weighing at least 5.5 lb (2.5 kg) and at least 4
months of age for a maximum of 3 days.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 520.2325a [Amended]
0
8. In Sec. 520.2325a, in paragraph (a)(3), remove ``053501'' and in
its place add ``054771''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
9. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
10. Revise Sec. 522.1055 to read as follows:
Sec. 522.1055 Gleptoferron.
(a) Specifications. Each milliliter (mL) contains the equivalent of
200 milligrams of elemental iron as gleptoferron, a complex of ferric
hydroxide and dextran glucoheptonic acid.
(b) Sponsors. See Nos. 059120 and 061623 in Sec. 510.600(c) of
this chapter.
(c) Conditions of use in swine--(1) Indications for use and
amounts--(i) Prevention of anemia due to iron deficiency: Administer 1
mL (200 mg iron) per pig by intramuscular injection on or before 3 days
of age.
(ii) Treatment of anemia due to iron deficiency: Administer 1 mL
(200 mg iron) per pig by intramuscular injection as soon as signs of
deficiency appear.
(2) [Reserved]
Sec. 522.1182 [Amended]
0
11. In Sec. 522.1182, in paragraph (b) introductory text, remove
``baby pigs'' and in its place add ``young piglets''; in paragraph
(b)(7) introductory text, remove ``000859'' and in its place add
``016592''; and in paragraphs (b)(7)(i) and (ii), remove ``baby pig''.
Sec. 522.1192 [Amended]
0
12. In Sec. 522.1192, in paragraph (b)(2), remove ``000859'' and in
its place add ``016592,''.
Sec. 522.1260 [Amended]
0
13. In Sec. 522.1260, in paragraph (b)(2), remove ``000859'' and in
its place add ``016592''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
14. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
15. In Sec. 524.1044h, revise paragraphs (a) and (b) to read as
follows:
Sec. 524.1044h Gentamicin, mometasone, and clotrimazole otic
suspension.
(a) Specifications. Each gram of suspension contains gentamicin
sulfate, United States Pharmacopeia (USP) equivalent to 3 milligram
(mg) gentamicin base, mometasone furoate monohydrate or mometasone
furoate anhydrous, USP, equivalent to 1 mg mometasone, and 10 mg
clotrimazole, USP.
(b) Sponsors. See Nos. 000061 and 054925 in Sec. 510.600(c) of
this chapter.
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
16. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
Sec. 558.4 [Amended]
0
17. In Sec. 558.4, in paragraph (d), in the ``Category I'' table, in
the ``Type B maximum (200 x)'' column, in the row entry for
``Avilamycin'', remove ``3.65 g/lb (0.8%)'' and in its place add ``7.3
g/lb (1.6%)''; and in the ``Category II'' table, remove the row entry
for ``Sulfadimethoxine'' and two following row entries for
``Ormetoprim'', and in their place add row entries for
``Sulfadimethoxine'' and ``Ormetoprim''.
The additions read as follows:
Sec. 558.4 Requirement of a medicated feed mill license.
* * * * *
(d) * * *
Category II
----------------------------------------------------------------------------------------------------------------
Assay limits
Drug percent \1\ Type Type B maximum (100 x) Assay limits
A percent Type B/C
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Sulfadimethoxine........................... 90-110 Poultry: 5.675 g/lb.......... 80-115/75-125
Fish: 85.1 g/lb..............
Ormetoprim................................. 90-110 Poultry: 3.405 g/lb.......... 80-115
Fish: 17.0 g/lb..............
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
18. In Sec. 558.68, revise paragraphs (a) and (e) to read as follows:
Sec. 558.68 Avilamycin.
(a) Each pound of Type A medicated article contains 45.4 or 90.7
grams of avilamycin.
* * * * *
(e) Conditions of use. Administer in feed as follows:
(1) Chickens--
[[Page 59135]]
----------------------------------------------------------------------------------------------------------------
Combination in
Avilamycin in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 13.6 to 40.9.................. .............. Broiler chickens: For Feed as the sole 000986
the prevention of ration for 21
mortality caused by consecutive days. To
necrotic enteritis assure responsible
associated with antimicrobial drug
Clostridium use in broiler
perfringens in chickens, treatment
broiler chickens. administration must
begin on or before
10 days of age.
(ii) [Reserved]...................
----------------------------------------------------------------------------------------------------------------
(2) Swine--
----------------------------------------------------------------------------------------------------------------
Combinationin
Avilamycin in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 73............................ .............. Weaned pigs less than Feed as the sole 000986
14 weeks of age: For ration for 21
the reduction in consecutive days. To
incidence and assure responsible
overall severity of antimicrobial drug
diarrhea in the use in pigs, do not
presence of administer to pigs
pathogenic 14 weeks of age or
Escherichia coli in older.
groups of weaned
pigs.
(ii) [Reserved]...................
----------------------------------------------------------------------------------------------------------------
Sec. 558.274 [Amended]
0
19. Effective September 8, 2016, in Sec. 558.274, remove and reserve
paragraphs (c)(1)(ii) and (c)(2)(ii).
0
20. Effective September 8, 2016, in Sec. 558.355, remove and reserve
paragraph (f)(1)(xxviii) and revise paragraphs (f)(8)(i) and (ii).
The revisions read as follows:
Sec. 558.355 Monensin.
* * * * *
(f) * * *
(8) * * *
(i) Decoquinate alone and in combination as in Sec. 558.195.
(ii) Melengestrol acetate alone and in combination as in Sec.
558.342.
* * * * *
Sec. 558.363 [Amended]
0
21. Effective September 8, 2016, in Sec. 558.363, remove and reserve
paragraph (d)(1)(vi).
Sec. 558.550 [Amended]
0
22. Effective September 8, 2016, in Sec. 558.550, remove and reserve
paragraph (d)(1)(xxii).
Sec. 558.618 [Amended]
0
23. In Sec. 558.618, in paragraphs (e)(2)(ii) and (iii):
0
a. In the ``Limitations'' column, add ``Tilmicosin as provided by Nos.
000986 or 016952; monensin as provided by No. 000986 in Sec.
510.600(c) of this chapter.'' to the end of the existing entries; and
0
b. In the ``Sponsor'' column, numerically add ``016952''.
0
24. Effective September 8, 2016, in Sec. 558.625, revise paragraphs
(b)(1), (f)(2)(i), (f)(2)(iii), and (f)(2)(vii) and remove paragraphs
(f)(2)(viii) and (ix).
The revisions read as follows:
Sec. 558.625 Tylosin.
* * * * *
(b) * * *
(1) No. 000986: 40 and 100 grams per pound for use as in paragraph
(f) of this section.
* * * * *
(f) * * *
(2) * * *
(i) Decoquinate alone and in combination as in Sec. 558.195.
* * * * *
(iii) Melengestrol acetate alone and in combination as in Sec.
558.342.
* * * * *
(vii) Zilpaterol alone and in combination as in Sec. 558.665.
0
25. Effective September 8, 2016, in Sec. 558.630, revise paragraph
(b)(1) to read as follows:
Sec. 558.630 Tylosin and sulfamethazine.
* * * * *
(b) * * *
(1) No. 000986: 40 and 100 grams per pound for use as in paragraph
(e) of this section.
* * * * *
Dated: August 8, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-19914 Filed 8-26-16; 8:45 am]
BILLING CODE 4164-01-P
