New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor's Name; Change of Sponsor's Address, 18773-18777 [2015-08025]
Download as PDF
<![CDATA[
18773
Rules and Regulations
Federal Register
Vol. 80, No. 67
Wednesday, April 8, 2015
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529,
and 558
[Docket No. FDA–2015–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Withdrawal
of Approval of New Animal Drug
Applications; Change of Sponsor;
Change of Sponsor’s Name; Change of
Sponsor’s Address
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
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
applications (ANADAs) during January
and February 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 several nonsubstantive changes. These technical
amendments are being made to improve
the accuracy of the regulations.
DATES: This rule is effective April 8,
2015, except for the amendment to 21
CFR 522.1004, which is effective April
20, 2015.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9019,
george.haibel@fda.hhs.gov.
SUMMARY:
FDA is
amending the animal drug regulations to
reflect approval actions for NADAs and
ANADAs during January and February
SUPPLEMENTARY INFORMATION:
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.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY AND FEBRUARY 2015
NADA/ANADA
Sponsor
141–435 ........
Piedmont Animal
Health, 204 Muirs
Chapel Rd., Suite
200, Greensboro, NC
27410.
Luitpold Pharmaceuticals, Inc., Animal Health Division,
Shirley, NY 11967.
141–418 ........
200–527 ........
asabaliauskas on DSK5VPTVN1PROD with RULES
200–576 ........
VerDate Sep<11>2014
Putney, Inc., One
Monument Sq., suite
400, Portland, ME
04101.
Akorn Animal Health,
Inc., 1925 West Field
Ct., suite 300, Lake
Forest, IL 60045.
16:24 Apr 07, 2015
Jkt 235001
New animal drug
product name
Action
21 CFR
sections
FOIA summary
NEPA review
ADVANTUS
(imidacloprid)
Chewable Tablets.
Original approval for
the treatment of flea
infestations on dogs
and puppies.
520.1156
yes .................
CE 1 2
BETAVET
(betamethasone sodium phosphate and
betamethasone acetate) Injectable Suspension.
Enrofloxacin Antibacterial Injectable
Solution.
Original approval for
the control of pain
and inflammation associated with osteoarthritis in horses.
522.167
yes .................
CE 1 2
Original approval as a
generic copy of
NADA 140–913.
522.812
yes .................
CE 1 3
Gentamicin Sulfate
Ophthalmic Solution.
Original approval as a
generic copy of
NADA 099–008.
524.1044a
yes .................
CE 1 3
PO 00000
Frm 00001
Fmt 4700
Sfmt 4700
E:\FR\FM\08APR1.SGM
08APR1
18774
Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Rules and Regulations
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY AND FEBRUARY 2015—
Continued
NADA/ANADA
Sponsor
New animal drug
product name
Action
21 CFR
sections
141–280 4 ......
Intervet, Inc., 556 Morris Ave., Summit, NJ
07901.
Supplemental approval
to provide for component feeding of combination drug Type C
medicated feeds to
heifers fed in confinement for slaughter.
558.665
yes .................
CE 1 5
141–406 ........
Merial, Inc., 3239 Satellite Blvd., Bldg.
500, Duluth, GA
30096–4640.
ZILMAX (zilpaterol hydrochloride) plus
RUMENSIN
(monensin) plus
TYLAN (tylosin phosphate) plus MGA
(melengestrol acetate) Type A medicated articles.
NEXGARD (afoxolaner)
Chewable Tablets.
Supplemental approval
for the treatment and
control of an additional tick species in
dogs and puppies.
520.43
yes .................
CE 1 2
FOIA summary
NEPA review
1 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.
2 CE granted under 21 CFR 25.33(d)(1).
3 CE granted under 21 CFR 25.33(a)(1).
4 This application is 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.
5 CE granted under 21 CFR 25.33(a)(2).
In addition during January and
February 2015, ownership of, and all
rights and interest in, the following
approved applications have been
transferred as follows:
NADA/ANADA
Previous sponsor
New animal drug product name
New sponsor
141–098 ........
Abbott Laboratories, North Chicago, IL 60064.
Abbott Laboratories, North Chicago, IL 60064.
Abbott Laboratories, North Chicago, IL 60064.
Abbott Laboratories, North Chicago, IL 60064.
Abbott Laboratories, North Chicago, IL 60064.
ADM Alliance Nutrition., Inc., 1000
North 30th St., Quincy, IL
62305–3115.
ADM Alliance Nutrition., Inc., 1000
North 30th St., Quincy, IL
62305–3115.
Contemporary Products, Inc., 3788
Elm Springs Rd., Springdale, AR
72764–6067.
Novartis Animal Health US, Inc.,
3200 Northline Ave., suite 300,
Greensboro, NC 27408.
Novartis Animal Health US, Inc.,
3200 Northline Ave., suite 300,
Greensboro, NC 27408.
PROPOFLO (propofol) Injectable
Suspension.
SEVOFLO (sevoflurane) Inhalation
Anesthetic.
OROCAM (meloxicam) Oral Spray
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.
Pharmgate LLC, 161 North Franklin Turnpike, suite 2C, Ramsey,
NJ 07446.
Pharmgate LLC, 161 North Franklin Turnpike, suite 2C, Ramsey,
NJ 07446.
Huvepharma AD, 5th Floor, 3A
Nikolay Haitov Str., 1113 Sofia,
Bulgaria.
Virbac AH, Inc., 3200 Meacham
Blvd., Ft. Worth, TX 76137.
141–103 ........
141–346 ........
141–434 ........
200–070 ........
048–480 ........
065–256 ........
200–197 ........
141–084 ........
141–204 ........
asabaliauskas on DSK5VPTVN1PROD with RULES
141–333 ........
141–067 ........
VerDate Sep<11>2014
Novartis Animal Health US, Inc.,
3200 Northline Ave., suite 300,
Greensboro, NC 27408.
OPK Biotech, LLC, 11 and 39 Hurley St., Cambridge, MA.
16:24 Apr 07, 2015
Jkt 235001
PO 00000
SIMBADOL
(buprenorphine)
Injectable Solution.
ISOFLO (isoflurane) Inhalation Anesthetic.
CHLORATET 90 and 100 (chlortetracycline) Type A medicated
articles.
CHLORTET-SOLUBLE-O
(chlortetracycline) Powder.
Streptomycin Oral Solution ............
SENTINEL (milbemycin oxime and
lufenuron) FLAVOR TABS.
SENTINEL (milbemycin oxime and
lufenuron) FLAVOR TABS and
CAPSTAR (nitenpyram) Tablets
Flea Management Program.
SENTINEL
SPECTRUM
(milbemycin
oxime/lufenuron/
praziquantel) Tablets.
OXYGLOBIN
(hemoglobin
glutamer-200 (bovine)).
Frm 00002
Fmt 4700
Sfmt 4700
21 CFR
Section
522.2005
529.2150
529.1350
522.230
529.1186
558.128
520.441
520.2158
522.1143
Virbac AH, Inc., 3200 Meacham
Blvd., Ft. Worth, TX 76137.
520.1510
Virbac AH, Inc., 3200 Meacham
Blvd., Ft. Worth, TX 76137.
520.1447
Hemoglobin Oxygen Therapeutics,
LLC,
674
Souder
Rd.,
Souderton, PA 18964.
522.1125
E:\FR\FM\08APR1.SGM
08APR1
18775
Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Rules and Regulations
At this time, the regulations are being
amended to reflect these changes of
sponsorship.
In addition, Paladin Labs (USA), Inc.,
160 Greentree Dr., Suite 101, Dover, DE
19904 has requested that FDA withdraw
approval of NADA 141–075 for
ANTIZOL–VET (fomepizole) Injection.
Elsewhere in this issue of the Federal
Register, FDA gave notice that approval
of NADA 141–075, and all supplements
and amendments thereto, is withdrawn,
effective April 20, 2015. As provided in
the regulatory text of this document, the
animal drug regulations are being
amended to reflect this voluntary
withdrawal of approval.
Following these changes of
sponsorship and withdrawal of
approval, Hemoglobin Oxygen
Therapeutics, LLC is now the sponsor of
an approved application while OPK
Biotech, LLC and Paladin Labs (USA),
Inc., are no longer the sponsor of an
approved application. Also, Merial Ltd.,
3239 Satellite Blvd., Bldg. 500, Duluth,
GA 30096–4640, has informed FDA that
it has changed its name to Merial, Inc.,
and Intervet, Inc., 556 Morris Ave.,
Summit, NJ 07901, has informed FDA
that it has changed its address to 2
Giralda Farms, Madison, NJ 07940.
Accordingly, § 510.600 (21 CFR
510.600) is being amended to reflect
these changes.
In addition, FDA is amending the
tables in § 510.600(c) to remove listings
for International Nutrition, Inc.;
NutriBasics Co.; Seeco Inc.; Southern
Micro-Blenders, Inc.; and Wellmark
International because these firms are no
longer the sponsor of an approved
application. These technical
amendments are being made to improve
the accuracy of the regulations.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
List of Subjects
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
asabaliauskas on DSK5VPTVN1PROD with RULES
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
VerDate Sep<11>2014
16:24 Apr 07, 2015
Jkt 235001
the Center for Veterinary Medicine, 21
CFR parts 510, 520, 522, 524, 529, and
558 are amended as follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
Drug labeler
code
*
*
050604 .........
*
*
*
Merial, Inc., 3239 Satellite
Blvd., Bldg. 500, Duluth,
GA 30096–4640.
*
*
063075 .........
*
*
*
Hemoglobin Oxygen Therapeutics, LLC, 674 Souder
Rd., Souderton, PA 18964.
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. Amend § 510.600 as follows:
a. In the table in paragraph (c)(1),
remove the entries for ‘‘Contemporary
Products, Inc.’’, ‘‘International
Nutrition, Inc.’’, ‘‘NutriBasics Co.’’,
‘‘OPK Biotech, LLC’’, ‘‘Paladin Labs
(USA), Inc.’’, ‘‘Seeco Inc.’’, ‘‘Southern
Micro-Blenders, Inc.’’, and ‘‘Wellmark
International’’;
■ b. In the table in paragraph (c)(1),
revise the entries for ‘‘Intervet, Inc.’’ and
‘‘Merial Ltd.’’; and add an entry, in
alphabetical order, for ‘‘Hemoglobin
Oxygen Therapeutics, LLC’’;
■ c. In the table in paragraph (c)(2),
remove the entries for ‘‘011536’’,
‘‘043733’’, ‘‘046129’’, and ‘‘055462’’;
and
■ d. In the table in paragraph (c)(2),
revise the entries for ‘‘000061’’,
‘‘050604’’, and ‘‘063075’’.
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
*
*
*
Hemoglobin Oxygen Therapeutics, LLC, 674 Souder
Rd., Souderton, PA 18964
*
*
063075
Firm name and address
*
*
*
*
*
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
4. In § 520.43, revise paragraph (c)(2)
to read as follows:
■
§ 520.43
Afoxolaner.
*
*
*
*
*
(c) * * *
(2) Indications for use. Kills adult
fleas; for the treatment and prevention
of flea infestations (Ctenocephalides
felis); for the treatment and control of
black-legged tick (Ixodes scapularis),
American dog tick (Dermacentor
variabilis), lone star tick (Amblyomma
americanum), and brown dog tick
(Rhipicephalus sanguineus) infestations
in dogs and puppies 8 weeks of age and
older, weighing 4 lb of body weight or
greater, for 1 month.
*
*
*
*
*
§ 520.441
[Amended]
5. In § 520.441, in paragraph (b)(4),
remove ‘‘012286’’ and in its place add
‘‘069254’’.
■ 6. Add § 520.1156 to read as follows:
■
§ 520.1156
Imidacloprid.
(a) Specifications. Each chewable
tablet contains 7.5 or 37.5 milligrams
000061 (mg) imidacloprid.
(b) Sponsor. See No. 000859 in
*
*
*
*
*
§ 510.600(c) of this chapter.
Merial, Inc., 3239 Satellite
(c) Conditions of use in dogs—(1)
Blvd., Bldg. 500, Duluth,
Amount. Administer daily one 7.5-mg
GA 30096–4640 ................
050604
chewable tablet to dogs weighing 4 to 22
pounds (lb) or one 37.5-mg chewable
*
*
*
*
*
table to dogs weighing 23 to 110 lb.
(2) Indications for use. Kills adult
(2) * * *
fleas and is indicated for the treatment
Drug labeler
of flea infestations on dogs and puppies
Firm name and address
code
10 weeks of age and older and weighing
4 lb or greater.
(3) Limitations. Do not give to puppies
*
*
*
*
*
younger than 10 weeks of age or to dogs
000061 ......... Intervet, Inc., 2 Giralda
Farms, Madison, NJ 07940. weighing less than 4 lb. Do not give
more than one tablet a day.
*
*
*
Intervet, Inc., 2 Giralda
Farms, Madison, NJ 07940
PO 00000
Frm 00003
Fmt 4700
*
Sfmt 4700
*
E:\FR\FM\08APR1.SGM
08APR1
18776
§ 520.1443
Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Rules and Regulations
[Amended]
7. In § 520.1443, in paragraph (b),
remove ‘‘058198’’ and in its place add
‘‘051311’’.
■
§ 520.1447
[Amended]
8. In § 520.1447, in paragraph (b),
remove ‘‘058198’’ and in its place add
‘‘051311’’.
■ 9. In § 520.1510, in paragraph
(d)(1)(ii)(B), remove ‘‘§ 520.1446(d)(1) of
this chapter’’ and in its place add
‘‘§ 520.1443(d)(1)’’; and revise the
section heading and paragraph (b) to
read as follows:
■
(2) Indications for use. For the control
of pain and inflammation associated
with osteoarthritis in horses.
(3) Limitations. Do not use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
(2) Indications for use. For the topical
treatment of infections of the
conjunctiva caused by susceptible
bacteria.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 522.230
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
13. In § 522.230, in paragraph (b),
remove ‘‘000044’’ and in its place add
‘‘054771’’.
■ 14. In § 522.812, add paragraph (b)(3)
to read as follows:
■
§ 522.812
§ 520.1510
Nitenpyram.
*
*
*
*
*
(b) Sponsors. See sponsor numbers in
§ 510.600(c) of this chapter:
(1) No. 058198 for use as in
paragraphs (d)(1)(i)(A), (d)(1)(ii)(A), and
(d)(2) of this section.
(2) No. 051311 for use as in
paragraphs (d)(1)(i)(B) and (d)(1)(ii)(B)
of this section.
*
*
*
*
*
§ 520.2158
[Amended]
10. In § 520.2158, in paragraph (b),
remove ‘‘Nos. 016592 and 055462’’ and
in its place add ‘‘No. 016592’’.
■
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
11. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
Jkt 235001
Authority: 21 U.S.C. 360b.
[Removed]
15. Remove § 522.1004.
■ 16. In § 522.2005, remove paragraph
(b)(3); and revise paragraph (b)(2) to
read as follows:
[Amended]
20. In § 529.1186, in paragraph (b),
remove ‘‘000044’’ and add ‘‘054771,’’
after ‘‘012164,’’.
■
§ 529.1350
[Amended]
21. In § 529.1350, in paragraph (b),
remove ‘‘000074’’ and in its place add
‘‘054771’’.
■
■
§ 522.2005
Propofol.
*
*
*
*
*
(b) * * *
(2) No. 054771 for use as in paragraph
(c) of this section.
*
*
*
*
*
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
17. The authority citation for 21 CFR
part 524 continues to read as follows:
18. Revise § 524.1044a to read as
follows:
■
(a) Specifications. Each milliliter (mL)
of suspension contains 6 milligrams
(mg) betamethasone (3.15 mg
betamethasone sodium phosphate and
2.85 mg betamethasone acetate).
(b) Sponsor. See No. 010797 in
§ 510.600(c) of this chapter.
(c) Conditions of use in horses—(1)
Amount. Administer 1.5 mL (9 mg total
betamethasone) per joint by intraarticular injection. May be administered
concurrently in up to two joints per
horse.
asabaliauskas on DSK5VPTVN1PROD with RULES
*
*
*
*
(b) * * *
(3) No. 026637 for use of product
described in paragraph (a)(1) as in
paragraph (e)(1) of this section.
*
*
*
*
*
Authority: 21 U.S.C. 360b.
§ 522.167 Betamethasone sodium
phosphate and betamethasone acetate.
16:24 Apr 07, 2015
*
§ 522.1004
19. The authority citation for 21 CFR
part 529 continues to read as follows:
■
§ 529.1186
Enrofloxacin.
■
12. Add § 522.167 to read as follows:
VerDate Sep<11>2014
[Amended]
§ 524.1044a
solution.
Gentamicin ophthalmic
(a) Specifications. Each milliliter of
solution contains gentamicin sulfate
equivalent to 3 milligrams of
gentamicin.
(b) Sponsors. See Nos. 000061 and
059399 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and
cats—(1) Amount. Administer 1 or 2
drops into the conjunctival sac 2 to 4
times a day.
PO 00000
Frm 00004
Fmt 4700
Sfmt 4700
§ 529.2150
[Amended]
22. In § 529.2150, in paragraph (b),
remove ‘‘000044’’ and add ‘‘054771,’’
after ‘‘012164,’’.
■
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
23. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
§ 558.128
[Amended]
24. Amend § 558.128 as follows:
a. In paragraph (b)(2), remove ‘‘No.
012286’’ and in its place add ‘‘No.
069254’’;
■ b. In paragraph (e)(3)(iv), in the
‘‘Limitations’’ column, remove
‘‘012286’’ and in its place add
‘‘069254’’; and
■ c. In the tables in paragraphs (e)(1),
(e)(2), (e)(3), and (e)(4), in the ‘‘Sponsor’’
column, remove ‘‘012286,’’ wherever it
occurs.
■ 25. In § 558.665, add paragraph (e)(9)
to read as follows:
■
■
§ 558.665
*
Zilpaterol.
*
*
(e) * * *
E:\FR\FM\08APR1.SGM
08APR1
*
*
18777
Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Rules and Regulations
Zilpaterol in
grams/ton
Combination in grams/ton
*
(9) 6.8 to 24 .......
*
Monensin 10 to 40, plus
tylosin 8 to 10, plus
melengestrol acetate to
provide 0.25 to 0.5 mg/
head/day.
Dated: April 3, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
Limitations
*
*
*
Heifers fed in confinement for slaughter: For
increased rate of weight gain, improved
feed efficiency, and increased carcass
leanness in cattle fed in confinement for
slaughter during the last 20 to 40 days on
feed; for prevention and control of coccidiosis due to Eimeria bovis and E.
zuernii; and for reduction of incidence of
liver abscesses caused by Fusobacterium
necrophorum
and
Arcanobacterium
(Actinomyces) pyogenes; and for suppression of estrus (heat).
*
Feed continuously to heifers
during the last 20 to 40
days on feed to provide 60
mg zilpaterol hydrochloride
per head per day. See
§§ 558.342(d), 558.355(d),
and 558.625(c). Monensin
and tylosin as provided by
No. 000986; melengestrol
acetate as provided by No.
054771 in § 510.600(c) of
this chapter. Withdrawal
period: 3 days.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
Veterinary Medicine, and in accordance
with § 514.116 Notice of withdrawal of
approval of application (21 CFR
514.116), notice is given that approval
of NADA 141–075, and all supplements
and amendments thereto, is hereby
withdrawn.
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.
[FR Doc. 2015–08025 Filed 4–7–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA–2015–N–0002]
Implantation or Injectable Dosage
Form New Animal Drugs; Withdrawal
of Approval of New Animal Drug
Application; Fomepizole
AGENCY:
Indications for use
Food and Drug Administration,
Dated: April 3, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015–08024 Filed 4–7–15; 8:45 am]
BILLING CODE 4164–01–P
HHS.
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of a new animal drug
application (NADA) for a fomepizole
injectable solution used as an antidote
for ethylene glycol poisoning in dogs.
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 April 20, 2015.
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9075,
sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Paladin
Labs (USA), Inc., 160 Greentree Dr.,
suite 101, Dover, DE 19904 has
requested that FDA withdraw approval
of NADA 141–075 for ANTIZOL–VET
(fomepizole) Injection because the
product is no longer manufactured or
marketed.
asabaliauskas on DSK5VPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
16:24 Apr 07, 2015
Jkt 235001
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 260 and 261
[EPA–HQ–RCRA–2015–0118; FRL_9923–12–
OSWER]
Response to Vacaturs of the
Comparable Fuels Rule and the
Gasification Rule
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is revising regulations
associated with the comparable fuels
exclusion and the gasification
exclusion, originally issued by EPA
under the Resource Conservation and
Recovery Act (RCRA). These revisions
implement vacaturs ordered by the
United States Court of Appeals for the
District of Columbia Circuit (D.C.
Circuit), on June 27, 2014.
DATES: Effective April 8, 2015.
SUMMARY:
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
Sponsor
*
000061
EPA has established a
docket for this action under Docket ID
No. EPA–HQ–RCRA–2015–0118. All
documents in the docket are listed in
the www.regulations.gov index.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically through
www.regulations.gov or in hard copy at
the EPA Docket Center, EPA/DC, WJC
West Building, Room 3334, 1301
Constitution Ave. NW., Washington,
DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m. Monday
through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744
and the telephone number for the RCRA
Docket is (202) 566–0270.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Office of Resource Conservation and
Recovery, Materials Recovery and Waste
Management Division, MC 5304P,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460, Tracy Atagi, at (703) 308–
8672, (atagi.tracy@epa.gov) or Frank
Behan, at (703) 308–8476, behan.frank@
epa.gov.
SUPPLEMENTARY INFORMATION:
Preamble Outline
I. General Information
II. Statutory Authority
III. Which regulations is EPA removing?
IV. Background on the Comparable Fuels
Rule and the Gasification Rule
V. When will the final rule become effective?
VI. State Authorization
VII. Statutory and Executive Order (EO)
Reviews
E:\FR\FM\08APR1.SGM
08APR1
]]>Agencies
[Federal Register Volume 80, Number 67 (Wednesday, April 8, 2015)]
[Rules and Regulations]
[Pages 18773-18777]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08025]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Rules
and Regulations
[[Page 18773]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529, and 558
[Docket No. FDA-2015-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications; Change of
Sponsor; Change of Sponsor's Name; Change of Sponsor's Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
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 January and February 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 several non-substantive
changes. These technical amendments are being made to improve the
accuracy of the regulations.
DATES: This rule is effective April 8, 2015, except for the amendment
to 21 CFR 522.1004, which is effective April 20, 2015.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9019,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect approval actions for NADAs and ANADAs during January and
February 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.
Table 1--Original and Supplemental NADAs and ANADAs Approved During January and February 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
New animal drug 21 CFR
NADA/ANADA Sponsor product name Action sections FOIA summary NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-435................ Piedmont Animal ADVANTUS Original approval for 520.1156 yes..................... CE 1 2
Health, 204 Muirs (imidacloprid) the treatment of
Chapel Rd., Suite Chewable Tablets. flea infestations on
200, Greensboro, NC dogs and puppies.
27410.
141-418................ Luitpold BETAVET (betamethasone Original approval for 522.167 yes..................... CE 1 2
Pharmaceuticals, sodium phosphate and the control of pain
Inc., Animal Health betamethasone and inflammation
Division, Shirley, NY acetate) Injectable associated with
11967. Suspension. osteoarthritis in
horses.
200-527................ Putney, Inc., One Enrofloxacin Original approval as 522.812 yes..................... CE 1 3
Monument Sq., suite Antibacterial a generic copy of
400, Portland, ME Injectable Solution. NADA 140-913.
04101.
200-576................ Akorn Animal Health, Gentamicin Sulfate Original approval as 524.1044a yes..................... CE 1 3
Inc., 1925 West Field Ophthalmic Solution. a generic copy of
Ct., suite 300, Lake NADA 099-008.
Forest, IL 60045.
[[Page 18774]]
141-280 \4\............ Intervet, Inc., 556 ZILMAX (zilpaterol Supplemental approval 558.665 yes..................... CE 1 5
Morris Ave., Summit, hydrochloride) plus to provide for
NJ 07901. RUMENSIN (monensin) component feeding of
plus TYLAN (tylosin combination drug
phosphate) plus MGA Type C medicated
(melengestrol feeds to heifers fed
acetate) Type A in confinement for
medicated articles. slaughter.
141-406................ Merial, Inc., 3239 NEXGARD (afoxolaner) Supplemental approval 520.43 yes..................... CE 1 2
Satellite Blvd., Chewable Tablets. for the treatment
Bldg. 500, Duluth, GA and control of an
30096-4640. additional tick
species in dogs and
puppies.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ 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.
\2\ CE granted under 21 CFR 25.33(d)(1).
\3\ CE granted under 21 CFR 25.33(a)(1).
\4\ This application is 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.
\5\ CE granted under 21 CFR 25.33(a)(2).
In addition during January and February 2015, ownership of, and all
rights and interest in, the following approved applications have been
transferred as follows:
----------------------------------------------------------------------------------------------------------------
New animal drug
NADA/ANADA Previous sponsor product name New sponsor 21 CFR Section
----------------------------------------------------------------------------------------------------------------
141-098................. Abbott Laboratories, PROPOFLO (propofol) Zoetis Inc., 333 522.2005
North Chicago, IL Injectable Suspension. Portage St.,
60064. Kalamazoo, MI 49007.
141-103................. Abbott Laboratories, SEVOFLO (sevoflurane) Zoetis Inc., 333 529.2150
North Chicago, IL Inhalation Anesthetic. Portage St.,
60064. Kalamazoo, MI 49007.
141-346................. Abbott Laboratories, OROCAM (meloxicam) Zoetis Inc., 333 529.1350
North Chicago, IL Oral Spray. Portage St.,
60064. Kalamazoo, MI 49007.
141-434................. Abbott Laboratories, SIMBADOL Zoetis Inc., 333 522.230
North Chicago, IL (buprenorphine) Portage St.,
60064. Injectable Solution. Kalamazoo, MI 49007.
200-070................. Abbott Laboratories, ISOFLO (isoflurane) Zoetis Inc., 333 529.1186
North Chicago, IL Inhalation Anesthetic. Portage St.,
60064. Kalamazoo, MI 49007.
048-480................. ADM Alliance CHLORATET 90 and 100 Pharmgate LLC, 161 558.128
Nutrition., Inc., (chlortetracycline) North Franklin
1000 North 30th St., Type A medicated Turnpike, suite 2C,
Quincy, IL 62305-3115. articles. Ramsey, NJ 07446.
065-256................. ADM Alliance CHLORTET-SOLUBLE-O Pharmgate LLC, 161 520.441
Nutrition., Inc., (chlortetracycline) North Franklin
1000 North 30th St., Powder. Turnpike, suite 2C,
Quincy, IL 62305-3115. Ramsey, NJ 07446.
200-197................. Contemporary Products, Streptomycin Oral Huvepharma AD, 5th 520.2158
Inc., 3788 Elm Solution. Floor, 3A Nikolay
Springs Rd., Haitov Str., 1113
Springdale, AR 72764- Sofia, Bulgaria.
6067.
141-084................. Novartis Animal Health SENTINEL (milbemycin Virbac AH, Inc., 3200 522.1143
US, Inc., 3200 oxime and lufenuron) Meacham Blvd., Ft.
Northline Ave., suite FLAVOR TABS. Worth, TX 76137.
300, Greensboro, NC
27408.
141-204................. Novartis Animal Health SENTINEL (milbemycin Virbac AH, Inc., 3200 520.1510
US, Inc., 3200 oxime and lufenuron) Meacham Blvd., Ft.
Northline Ave., suite FLAVOR TABS and Worth, TX 76137.
300, Greensboro, NC CAPSTAR (nitenpyram)
27408. Tablets Flea
Management Program.
141-333................. Novartis Animal Health SENTINEL SPECTRUM Virbac AH, Inc., 3200 520.1447
US, Inc., 3200 (milbemycin oxime/ Meacham Blvd., Ft.
Northline Ave., suite lufenuron/ Worth, TX 76137.
300, Greensboro, NC praziquantel) Tablets.
27408.
141-067................. OPK Biotech, LLC, 11 OXYGLOBIN (hemoglobin Hemoglobin Oxygen 522.1125
and 39 Hurley St., glutamer-200 Therapeutics, LLC,
Cambridge, MA. (bovine)). 674 Souder Rd.,
Souderton, PA 18964.
----------------------------------------------------------------------------------------------------------------
[[Page 18775]]
At this time, the regulations are being amended to reflect these
changes of sponsorship.
In addition, Paladin Labs (USA), Inc., 160 Greentree Dr., Suite
101, Dover, DE 19904 has requested that FDA withdraw approval of NADA
141-075 for ANTIZOL-VET (fomepizole) Injection. Elsewhere in this issue
of the Federal Register, FDA gave notice that approval of NADA 141-075,
and all supplements and amendments thereto, is withdrawn, effective
April 20, 2015. As provided in the regulatory text of this document,
the animal drug regulations are being amended to reflect this voluntary
withdrawal of approval.
Following these changes of sponsorship and withdrawal of approval,
Hemoglobin Oxygen Therapeutics, LLC is now the sponsor of an approved
application while OPK Biotech, LLC and Paladin Labs (USA), Inc., are no
longer the sponsor of an approved application. Also, Merial Ltd., 3239
Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640, has informed FDA
that it has changed its name to Merial, Inc., and Intervet, Inc., 556
Morris Ave., Summit, NJ 07901, has informed FDA that it has changed its
address to 2 Giralda Farms, Madison, NJ 07940. Accordingly, Sec.
510.600 (21 CFR 510.600) is being amended to reflect these changes.
In addition, FDA is amending the tables in Sec. 510.600(c) to
remove listings for International Nutrition, Inc.; NutriBasics Co.;
Seeco Inc.; Southern Micro-Blenders, Inc.; and Wellmark International
because these firms are no longer the sponsor of an approved
application. These technical amendments are being made to improve the
accuracy of the regulations.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
520, 522, 524, 529, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. Amend Sec. 510.600 as follows:
0
a. In the table in paragraph (c)(1), remove the entries for
``Contemporary Products, Inc.'', ``International Nutrition, Inc.'',
``NutriBasics Co.'', ``OPK Biotech, LLC'', ``Paladin Labs (USA),
Inc.'', ``Seeco Inc.'', ``Southern Micro-Blenders, Inc.'', and
``Wellmark International'';
0
b. In the table in paragraph (c)(1), revise the entries for ``Intervet,
Inc.'' and ``Merial Ltd.''; and add an entry, in alphabetical order,
for ``Hemoglobin Oxygen Therapeutics, LLC'';
0
c. In the table in paragraph (c)(2), remove the entries for ``011536'',
``043733'', ``046129'', and ``055462''; and
0
d. In the table in paragraph (c)(2), revise the entries for ``000061'',
``050604'', and ``063075''.
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
------------------------------------------------------------------------
* * * * *
Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., 063075
Souderton, PA 18964....................................
* * * * *
Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940...... 000061
* * * * *
Merial, Inc., 3239 Satellite Blvd., Bldg. 500, Duluth, 050604
GA 30096-4640..........................................
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
000061.............................. Intervet, Inc., 2 Giralda Farms,
Madison, NJ 07940.
* * * * *
050604.............................. Merial, Inc., 3239 Satellite
Blvd., Bldg. 500, Duluth, GA
30096-4640.
* * * * *
063075.............................. Hemoglobin Oxygen Therapeutics,
LLC, 674 Souder Rd., Souderton,
PA 18964.
* * * * *
------------------------------------------------------------------------
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 520.43, revise paragraph (c)(2) to read as follows:
Sec. 520.43 Afoxolaner.
* * * * *
(c) * * *
(2) Indications for use. Kills adult fleas; for the treatment and
prevention of flea infestations (Ctenocephalides felis); for the
treatment and control of black-legged tick (Ixodes scapularis),
American dog tick (Dermacentor variabilis), lone star tick (Amblyomma
americanum), and brown dog tick (Rhipicephalus sanguineus) infestations
in dogs and puppies 8 weeks of age and older, weighing 4 lb of body
weight or greater, for 1 month.
* * * * *
Sec. 520.441 [Amended]
0
5. In Sec. 520.441, in paragraph (b)(4), remove ``012286'' and in its
place add ``069254''.
0
6. Add Sec. 520.1156 to read as follows:
Sec. 520.1156 Imidacloprid.
(a) Specifications. Each chewable tablet contains 7.5 or 37.5
milligrams (mg) imidacloprid.
(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer daily one
7.5-mg chewable tablet to dogs weighing 4 to 22 pounds (lb) or one
37.5-mg chewable table to dogs weighing 23 to 110 lb.
(2) Indications for use. Kills adult fleas and is indicated for the
treatment of flea infestations on dogs and puppies 10 weeks of age and
older and weighing 4 lb or greater.
(3) Limitations. Do not give to puppies younger than 10 weeks of
age or to dogs weighing less than 4 lb. Do not give more than one
tablet a day.
[[Page 18776]]
Sec. 520.1443 [Amended]
0
7. In Sec. 520.1443, in paragraph (b), remove ``058198'' and in its
place add ``051311''.
Sec. 520.1447 [Amended]
0
8. In Sec. 520.1447, in paragraph (b), remove ``058198'' and in its
place add ``051311''.
0
9. In Sec. 520.1510, in paragraph (d)(1)(ii)(B), remove ``Sec.
520.1446(d)(1) of this chapter'' and in its place add ``Sec.
520.1443(d)(1)''; and revise the section heading and paragraph (b) to
read as follows:
Sec. 520.1510 Nitenpyram.
* * * * *
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter:
(1) No. 058198 for use as in paragraphs (d)(1)(i)(A),
(d)(1)(ii)(A), and (d)(2) of this section.
(2) No. 051311 for use as in paragraphs (d)(1)(i)(B) and
(d)(1)(ii)(B) of this section.
* * * * *
Sec. 520.2158 [Amended]
0
10. In Sec. 520.2158, in paragraph (b), remove ``Nos. 016592 and
055462'' and in its place add ``No. 016592''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
11. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
12. Add Sec. 522.167 to read as follows:
Sec. 522.167 Betamethasone sodium phosphate and betamethasone
acetate.
(a) Specifications. Each milliliter (mL) of suspension contains 6
milligrams (mg) betamethasone (3.15 mg betamethasone sodium phosphate
and 2.85 mg betamethasone acetate).
(b) Sponsor. See No. 010797 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses--(1) Amount. Administer 1.5 mL (9
mg total betamethasone) per joint by intra-articular injection. May be
administered concurrently in up to two joints per horse.
(2) Indications for use. For the control of pain and inflammation
associated with osteoarthritis in horses.
(3) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
Sec. 522.230 [Amended]
0
13. In Sec. 522.230, in paragraph (b), remove ``000044'' and in its
place add ``054771''.
0
14. In Sec. 522.812, add paragraph (b)(3) to read as follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(b) * * *
(3) No. 026637 for use of product described in paragraph (a)(1) as
in paragraph (e)(1) of this section.
* * * * *
Sec. 522.1004 [Removed]
0
15. Remove Sec. 522.1004.
0
16. In Sec. 522.2005, remove paragraph (b)(3); and revise paragraph
(b)(2) to read as follows:
Sec. 522.2005 Propofol.
* * * * *
(b) * * *
(2) No. 054771 for use as in paragraph (c) of this section.
* * * * *
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
17. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
18. Revise Sec. 524.1044a to read as follows:
Sec. 524.1044a Gentamicin ophthalmic solution.
(a) Specifications. Each milliliter of solution contains gentamicin
sulfate equivalent to 3 milligrams of gentamicin.
(b) Sponsors. See Nos. 000061 and 059399 in Sec. 510.600(c) of
this chapter.
(c) Conditions of use in dogs and cats--(1) Amount. Administer 1 or
2 drops into the conjunctival sac 2 to 4 times a day.
(2) Indications for use. For the topical treatment of infections of
the conjunctiva caused by susceptible bacteria.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
19. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 529.1186 [Amended]
0
20. In Sec. 529.1186, in paragraph (b), remove ``000044'' and add
``054771,'' after ``012164,''.
Sec. 529.1350 [Amended]
0
21. In Sec. 529.1350, in paragraph (b), remove ``000074'' and in its
place add ``054771''.
Sec. 529.2150 [Amended]
0
22. In Sec. 529.2150, in paragraph (b), remove ``000044'' and add
``054771,'' after ``012164,''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
23. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.128 [Amended]
0
24. Amend Sec. 558.128 as follows:
0
a. In paragraph (b)(2), remove ``No. 012286'' and in its place add
``No. 069254'';
0
b. In paragraph (e)(3)(iv), in the ``Limitations'' column, remove
``012286'' and in its place add ``069254''; and
0
c. In the tables in paragraphs (e)(1), (e)(2), (e)(3), and (e)(4), in
the ``Sponsor'' column, remove ``012286,'' wherever it occurs.
0
25. In Sec. 558.665, add paragraph (e)(9) to read as follows:
Sec. 558.665 Zilpaterol.
* * * * *
(e) * * *
[[Page 18777]]
----------------------------------------------------------------------------------------------------------------
Combination in
Zilpaterol in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(9) 6.8 to 24.................... Monensin 10 to 40, Heifers fed in Feed continuously 000061
plus tylosin 8 to confinement for to heifers during
10, plus slaughter: For the last 20 to 40
melengestrol increased rate of days on feed to
acetate to provide weight gain, provide 60 mg
0.25 to 0.5 mg/ improved feed zilpaterol
head/day. efficiency, and hydrochloride per
increased carcass head per day. See
leanness in cattle Sec. Sec.
fed in confinement 558.342(d),
for slaughter 558.355(d), and
during the last 20 558.625(c).
to 40 days on Monensin and
feed; for tylosin as
prevention and provided by No.
control of 000986;
coccidiosis due to melengestrol
Eimeria bovis and acetate as
E. zuernii; and provided by No.
for reduction of 054771 in Sec.
incidence of liver 510.600(c) of this
abscesses caused chapter.
by Fusobacterium Withdrawal period:
necrophorum and 3 days.
Arcanobacterium
(Actinomyces)
pyogenes; and for
suppression of
estrus (heat).
----------------------------------------------------------------------------------------------------------------
Dated: April 3, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-08025 Filed 4-7-15; 8:45 am]
BILLING CODE 4164-01-P
