New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship, 17604-17610 [2016-07135]
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Federal Register / Vol. 81, No. 61 / Wednesday, March 30, 2016 / Rules and Regulations
(Lat. 37°19′31″ N., long. 79°12′04″ W.)
Falwell Airport, VA
(Lat. 37°22′41″ N., long. 79°07′20″ W.)
That airspace extending upward from the
surface to and including 3,400 feet MSL
within a 4.5-mile radius of Lynchburg
Municipal-Preston Glenn Field Airport,
excluding the portion within a .5-mile radius
of Falwell Airport. This Class D airspace area
is effective during the specific dates and
times established in advance by a Notice to
Airmen. The effective date and time will
thereafter be published continuously in the
Airport/Facility Directory.
Paragraph 6004 Class E Airspace
Designated as an Extension to a Class D
Surface Area.
*
*
*
AEA VA E4
*
*
BILLING CODE 4910–13–P
Lynchburg, VA [Corrected]
Paragraph 6005 Class E Airspace Areas
Extending Upward From 700 Feet or More
Above the Surface of the Earth.
*
Issued in College Park, Georgia, on March
23, 2016.
Jim Dickinson,
Acting Manager, Operations Support Group,
Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2016–07079 Filed 3–29–16; 8:45 am]
Lynchburg Regional-Preston Glenn Field
Airport, Lynchburg, VA
(Lat. 37°19′31″ N., long. 79°12′04″ W.)
Lynchburg VORTAC
(Lat. 37°15′17″ N., long. 79°14′11″ W.)
That airspace extending upward from the
surface within 2.7 miles each side of the
Lynchburg VORTAC 020° and 200° radials
extending from the 4.5-mile radius of
Lynchburg Municipal-Preston Glenn Field
Airport to 1 mile south of the VORTAC, and
within 1.8 miles each side of the Lynchburg
VORTAC 022° radial extending from the 4.5mile radius of the airport to 11.3 miles
northeast of the VORTAC. This Class E
airspace area is effective during the specific
dates and times established in advance by a
Notice to Airmen. The effective date and time
will thereafter be published continuously in
the Airport/Facility Directory.
*
That airspace extending upward from 700
feet above the surface within a 6.5-mile
radius of Lynchburg Regional-Preston Glenn
Field, and within 2.7 miles each side of the
Lynchburg VORTAC 200° radial extending
from the 6.5-mile radius to 7.4 miles south
of the VORTAC, and within 3.1 miles each
side of the Lynchburg VORTAC 022° radial
extending from the 6.5-mile radius to 21.3
miles northeast of the VORTAC, and within
a 6.5-mile radius of Falwell Airport.
*
AEA VA E5
*
*
Lynchburg, VA [Corrected]
Lynchburg Regional-Preston Glenn Field
Airport, Lynchburg, VA
(Lat. 37°19′31″ N., long. 79°12′04″ W.)
Lynchburg VORTAC
(Lat. 37°15′17″ N., long. 79°14′11″ W.)
Falwell Airport, VA
(Lat. 37°22′41″ N., long. 79°07′20″ W.)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 528,
529, 556, and 558
[Docket No. FDA–2015–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Changes of
Sponsorship
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
application-related actions for new
animal drug applications (NADAs) and
abbreviated new animal drug
applications (ANADAs) during
November and December 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
SUMMARY:
amended to reflect changes of
sponsorship of applications that
occurred in November and December
2015.
DATES:
This rule is effective March 30,
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
November and December 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 NOVEMBER AND DECEMBER 2015
21 CFR
Section
Sponsor
Product name
Action
141–453 ................
asabaliauskas on DSK3SPTVN1PROD with RULES
File No.
Alexion Pharmaceuticals, Inc.,
33 Hayden Ave., Lexington,
MA 02421.
hLAL rDNA construct in SBC
LAL–C chickens.
141–456 ................
Orion Corp., Orionintie 1, 02200
Espoo, Finland.
SILEO
(dexmedetomidine
oromucosal gel).
141–246 ................
Intervet, Inc., 556 Morris Ave.,
Summit, NJ 07901.
AQUAFLOR (florfenicol) Type A
medicated article.
Original approval for expression
of a human gene for recombinant human lysosomal acid
lipase (rhLAL) protein in
chicken egg whites.
Original approval for the treatment of noise aversion in
dogs.
Supplemental approval of revised representative labeling
for Type C medicated feeds;
technical amendments revising the expiration of veterinary
feed directives (VFDs) and
the description of tolerances
for fish.
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FOIA
Summary
NEPA
Review
528.2010
yes ........
EA/
FONSI 1
529.539
yes ........
CE 2 3
556.283,
558.261
no ..........
CE 2 4
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Federal Register / Vol. 81, No. 61 / Wednesday, March 30, 2016 / Rules and Regulations
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING NOVEMBER AND DECEMBER 2015—
Continued
21 CFR
Section
File No.
Sponsor
Product name
Action
141–258 ................
Intervet, Inc., 556 Morris Ave.,
Summit, NJ 07901.
ZILMAX
(zilpaterol
hydrochloride) Type A medicated
article.
141–361 ................
Elanco Animal Health, A Division of Eli Lilly & Co., Lilly
Corporate Center, Indianapolis, IN 46285.
PULMOTIL AC (tilmicosin phosphate) Concentrate Solution.
Supplemental approval of a cattle muscle tolerance and of
new determinative and confirmatory procedures for residues of zilpaterol in cattle
liver and muscle.
Supplemental approval for the
control of swine respiratory
disease
associated
with
Mycoplasma hyopneumoniae
in the presence of Porcine
Reproductive and Respiratory
Syndrome Virus (PRRSV).
FOIA
Summary
NEPA
Review
556.765
yes ........
CE 2 4
520.2471
yes ........
EA/
FONSI 1
1 The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of no significant impact (FONSI).
2 The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an environmental impact statement because it is of a type that does not have a significant effect on the human environment.
3 CE granted under 21 CFR 25.33(d)(1).
4 CE granted under 21 CFR 25.33(a)(1).
II. Changes of Sponsorship
Bayer HealthCare LLC, Animal Health
Division, P.O. Box 390, Shawnee
Mission, KS 66201 (Bayer) has informed
FDA that it has transferred ownership
of, and all rights and interest in, the
following approved applications to
File No.
055–002
094–170
123–815
141–245
200–178
200–193
200–248
200–265
200–287
200–297
200–298
200–365
200–382
Cronus Pharma LLC, 2 Tower Center
Blvd., Suite 1101, East Brunswick, NJ
08816:
21 CFR
section
Product name
.....................................................
.....................................................
.....................................................
.....................................................
.....................................................
.....................................................
.....................................................
.....................................................
.....................................................
.....................................................
.....................................................
.....................................................
.....................................................
TEVCOSIN (chloramphenicol) Injectable Solution ......................................................
Phenylbutazone Tablets, USP 100 mg and 200 mg ..................................................
Dexamethasone Sodium Phosphate Injection ............................................................
TRIBUTAME (chloroquine phosphate, embutramid, lidocaine) Euthanasia Solution
Amikacin Sulfate Injection, 50 mg/mL .........................................................................
Clindamycin Hydrochloride Oral Liquid .......................................................................
Pyrantel Pamoate Suspension; 2.27 and 4.54 mg .....................................................
Praziquantel Tablets ....................................................................................................
GBC (Gentamicin Sulfate Betamethasone Valerate Clotrimazole) Ointment .............
Ivermectin Chewable Tablets ......................................................................................
Clindamycin Hydrochloride Capsules .........................................................................
ROBINUL–V (glycopyrrolate) Injectable Solution .......................................................
Furosemide Syrup 1% .................................................................................................
Bayer has also informed FDA that it
has transferred ownership of, and all
rights and interest in, approved ANADA
200–342 for Pyrantel Pamoate Paste to
Farnam Companies, Inc., 301 West
Osborn Rd., Phoenix, AZ 85013–3928.
Boehringer Ingelheim Vetmedica, Inc.,
2621 North Belt Hwy., St. Joseph, MO
64506–2002 has informed FDA that it
has transferred ownership of, and all
rights and interest in, the following
approved applications to Huvepharma
AD, 5th Floor, 3A Nikolay Haitov Str.,
1113 Sofia, Bulgaria:
21 CFR section
Product name
006–084 1 ...................................................
008–774 .....................................................
033–373 1 ...................................................
040–181 1 ...................................................
055–012 1 ...................................................
asabaliauskas on DSK3SPTVN1PROD with RULES
File No.
SULMET (sulfamethazine) Drinking Water Solution ...................................................
SULMET (sulfamethazine) Injectable Solution ...........................................................
VETSULID (sulfachlorpyridazine) ................................................................................
VETSULID (sulfachlorpyridazine) Oral Suspension ....................................................
CHLORONEX SULMET (chlortetracycline bisulfate/sulfamethazine bisulfate) Soluble Powder.
AUREOMYCIN (chlortetracycline HCl) Tablets 25 mg ...............................................
AUREOMYCIN (chlortetracycline HCl) Soluble Oblets ...............................................
AUREOMYCIN (chlortetracycline HCl) Soluble Powder .............................................
POLYOTIC (tetracycline hydrochloride) Soluble Powder ...........................................
CHLORONEX (chlortetracycline HCl or chlortetracycline bisulfate) Soluble Powder
SULMET (sulfamethazine) Oblets ...............................................................................
SULMET (sulfamethazine sodium) Soluble Powder ...................................................
055–018 1
055–039 1
065–071 1
065–269 1
065–440 1
122–271 1
122–272 1
...................................................
...................................................
...................................................
...................................................
...................................................
...................................................
...................................................
522.390
520.1720a
522.540
522.810
522.56
520.447
520.2043
520.1870
524.1044g
520.1193
520.446
522.1066
520.1010
520.2261a
522.2260
520.2200
520.2200
520.445
520.443
520.443
520.441
520.2345d
520.441
520.2260a
520.2261b
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.
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Federal Register / Vol. 81, No. 61 / Wednesday, March 30, 2016 / Rules and Regulations
In addition, Novartis Animal Health
US, Inc., 3200 Northline Ave., suite 300,
Greensboro, NC 27408 (Novartis) has
informed FDA that it has transferred
ownership of, and all rights and interest
in, the following approved applications
File No.
134–644
139–472
140–915
140–916
141–011
141–026
141–029
141–035
141–062
141–084
141–105
141–120
141–163
141–175
141–203
141–204
141–205
141–218
141–320
141–329
141–333
141–338
141–437
141–443
200–517
200–519
Product name
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As provided in the regulatory text of
this document, the animal drug
regulations are amended to reflect these
changes of sponsorship. Elanco US, Inc.,
is retaining Novartis’ drug labeler code
(058198). Accordingly, the animal drug
regulations need only be amended in
§ 510.600(c) to add Elanco US, Inc., who
previously was not the sponsor of an
approved application. Cronus Pharma
LLC will also be added as a new listing.
Following these changes of sponsorship,
Novartis is no longer the sponsor of an
approved application and will be
removed from § 510.600(c).
asabaliauskas on DSK3SPTVN1PROD with RULES
III. Technical Amendments
FDA has noticed the animal drug
regulations in 21 CFR part 556 contain
tolerances for residues in edible tissues
for sulfathiazole, which is no longer the
subject of an approved application (79
FR 15540, March 20, 2014).
Accordingly, § 556.690 is being
removed. FDA has also noticed that the
animal drug regulations in 21 CFR 558.4
(§ 558.4) contain assay limits for ronnel
and sulfaethoxypyridazine in medicated
feed. As there is no longer an approved
application for use of either of these
drugs in medicated feed, the table for
Category II drugs in § 558.4 is being
amended to remove assay limits in
VerDate Sep<11>2014
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to Elanco US, Inc., 2500 Innovation
Way, Greenfield, IN 46140.
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DENAGARD (tiamulin) Soluble Powder.
DENAGARD (tiamulin) Type B Medicated Feed.
INTERCEPTOR (milbemycin oxime) Tablets.
DENAGARD (tiamulin) Liquid Concentrate.
DENAGARD (tiamulin) plus CTC (chlortetracycline).
PROGRAM (lufenuron) Suspension.
PERCORTEN–V (desoxycorticosterone pivalate) Injectable Suspension.
PROGRAM (lufenuron).
PROGRAM (lufenuron) Cat Flavor Tabs.
SENTINEL (lufenuron and milbemycin oxime) Flavor Tabs.
PROGRAM (lufenuron) 6-Month Injectable for Cats.
CLOMICALM (clomipramine) Tablets.
MILBEMITE (milbemycin oxime) Otic Solution.
CAPSTAR (nitenpyram) Tablets.
DERAMAXX (deracoxib) Chewable Tablets.
SENTINEL Flavor Tabs and CAPSTAR Flea Management System.
PROGRAM Flavor Tabs and CAPSTAR Flea Management System.
ATOPICA (cyclosporine) Capsules.
ONSIOR (robenacoxib) Tablets.
ATOPICA (cyclosporine) Oral Solution for Cats.
SENTINEL SPECTRUM (milbemycin oxime, lufenuron, praziquantel) Chewable Tablets.
INTERCEPTOR SPECTRUM (milbemycin oxime and praziquantel) Chewable Tablets.
OSURNIA (florfenicol, betamethasone acetate, and terbinafine) Otic Gel.
ONSIOR (robenacoxib) Injection.
ZOBUXA (enrofloxacin) Tablets.
FLORVIO (florfenicol) 2.3% Concentrate Solution.
medicated feed for both drugs. These
actions are being taken to improve the
accuracy of the regulations.
In addition, FDA is taking this
opportunity to revise the spelling of a
bacitracin salt to a preferred form,
bacitracin methylenedisalicylate, and to
correct the spelling of a genus of
pathogenic bacteria, Haemophilus.
These actions are 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.
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Parts 520, 522, 524, 528, and
529
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
Fmt 4700
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.
§ 510.600
[Amended]
2. In § 510.600, in the table in
paragraph (c)(1), remove the entry for
‘‘Novartis Animal Health US, Inc.’’ and
add entries for ‘‘Cronus Pharma LLC’’
and ‘‘Elanco US, Inc.’’ in alphabetical
order; and in the table in paragraph
(c)(2), revise the entry for ‘‘058198’’ and
add an entry for ‘‘069043’’ in numerical
order to read as follows:
Sfmt 4700
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
21 CFR Part 558
Animal drugs, Animal feeds.
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PART 510—NEW ANIMAL DRUGS
■
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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, 528, 529,
556, and 558 are amended as follows:
*
*
(c) * * *
(1) * * *
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Federal Register / Vol. 81, No. 61 / Wednesday, March 30, 2016 / Rules and Regulations
Drug labeler
code
Firm name and address
*
*
*
*
*
*
Cronus Pharma LLC, 2 Tower Center Blvd., Suite 1101, East Brunswick, NJ 08816 ........................................................................
*
069043
*
*
*
*
*
*
Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140 .............................................................................................................
*
058198
*
*
*
*
*
*
*
*
*
(2) * * *
Drug labeler code
Firm name and address
*
*
058198 ...............................................................
*
*
*
Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140
*
*
069043 ...............................................................
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*
*
*
Cronus Pharma LLC, 2 Tower Center Blvd., Suite 1101, East Brunswick, NJ 08816
*
*
*
§ 520.446
Authority: 21 U.S.C. 360b.
[Amended]
4. In § 520.88b, in paragraph
(b)(1)(ii)(B), remove ‘‘Hemophilus’’ and
in its place add ‘‘Haemophilus’’.
■ 5. In § 520.154b:
■ a. Revise the section heading.
■ b. In paragraph (a), remove
‘‘methylene disalicylate’’ and in its
place add ‘‘methylenedisalicylate’’.
The revision reads as follows:
§ 520.441
[Amended]
[Amended]
7. In § 520.443, in paragraph (b),
remove ‘‘No. 054628’’ and in its place
add ‘‘Nos. 016592 and 054628’’; and in
paragraphs (d)(1)(i), (d)(2)(i), and
(d)(3)(i), remove ‘‘Hemophilus’’ and in
its place add ‘‘Haemophilus’’.
asabaliauskas on DSK3SPTVN1PROD with RULES
■
[Amended]
8. In § 520.445, in paragraph (b),
remove ‘‘000010’’ and in its place add
‘‘016592’’.
■
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§ 520.2044
[Amended]
11. In § 520.823, in paragraph
(d)(2)(ii), remove ‘‘Hemophilus’’ and in
its place add ‘‘Haemophilus’’.
■
§ 520.1010
§ 520.2200
[Amended]
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[Amended]
17. In § 520.2044, in paragraph (b)(2),
remove ‘‘000859’’ and in its place add
‘‘017135’’.
■
[Amended]
18. In § 520.2200, in paragraph (b),
remove ‘‘000010’’ and in its place add
‘‘016592’’.
■
§ 520.1193
*
6. In § 520.441, in paragraphs (b)(2)
and (d)(4)(iii)(C), remove ‘‘000010’’ and
in its place add ‘‘016592’’; and in in
paragraphs (d)(1)(i)(A)(1), (d)(2)(i)(A)(1),
(d)(4)(iii)(B), and (d)(4)(iv)(B), remove
‘‘Hemophilus’’ and in its place add
‘‘Haemophilus’’.
§ 520.445
§ 520.823
[Amended]
16. In § 520.2043, in paragraph (b)(1),
remove ‘‘Nos. 000859, 054771, and
058829’’ and in its place add ‘‘Nos.
054771, 058829, and 069043’’.
■
12. In § 520.1010, in paragraph (b)(3),
remove ‘‘Nos. 000859 and 058829’’ and
in its place add ‘‘Nos. 058829 and
069043’’.
■
§ 520.443
§ 520.2043
[Amended]
10. In § 520.447, in paragraph (b),
remove ‘‘Nos. 000859, 051311, 054771,
058829, and 061623’’ and in its place
add ‘‘Nos. 051311, 054771, 058829,
061623, and 069043’’.
■
■
§ 520.154b Bacitracin
methylenedisalicylate and streptomycin
sulfate powder.
*
*
described in paragraph (a)(2) of this
section as in paragraph (c)(2) of this
section.
*
*
*
*
*
■
■
*
*
§ 520.447
3. The authority citation for 21 CFR
part 520 continues to read as follows:
*
[Amended]
■
■
*
*
9. In § 520.446, in paragraph (b)(1),
remove ‘‘No. 054771’’ and in its place
add ‘‘Nos. 054771 and 069043’’.
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
§ 520.88b
*
[Amended]
13. In § 520.1193, in paragraph (b)(2),
remove ‘‘Nos. 000859 and 051311’’ and
in its place add ‘‘Nos. 051311 and
069043’’.
■
§ 520.1720a
[Amended]
14. In § 520.1720a, in paragraph (b)(2),
remove ‘‘Nos. 000859 and 054628’’ and
in its place add ‘‘Nos. 054628 and
069043’’.
■ 15. In § 520.1870, revise paragraph (b)
to read as follows:
■
§ 520.1870
*
*
*
*
(b) Sponsor. See No. 069043 in
§ 510.600(c) of this chapter for use of the
product described in paragraph (a)(1) of
this section as in paragraph (c)(1) of this
section; and for use of the product
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[Amended]
19. In § 520.2260a, in paragraph (a)(1),
remove ‘‘000010’’ and in its place add
‘‘016592’’.
§ 520.2261a
[Amended]
20. In § 520.2261a, in paragraph (b),
remove ‘‘000010’’ and in its place add
‘‘016592’’.
■
§ 520.2261b
[Amended]
21. In § 520.2261b, in paragraph (b),
remove ‘‘000010’’ and in its place add
‘‘016592’’.
■
§ 520.2345d
Praziquantel tablets.
*
§ 520.2260a
[Amended]
22. In § 520.2345d, in paragraphs
(b)(5), (d)(1)(iii), and (d)(2)(iii), remove
‘‘000010’’ and in its place add
‘‘016592’’; and in paragraphs (d)(1)(ii)
and (d)(2)(ii), remove ‘‘Hemophilus’’
and in its place add ‘‘Haemophilus’’.
■
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23. In § 520.2471, revise paragraph
(d)(2) to read as follows:
■
§ 520.2471
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
Tilmicosin.
*
*
*
*
*
(d) * * *
(2) Indications for use—(i) For the
control of swine respiratory disease
associated with Pasteurella multocida
and Haemophilus parasuis in groups of
swine in buildings where a respiratory
disease outbreak is diagnosed.
(ii) For the control of swine
respiratory disease associated with
Mycoplasma hyopneumoniae in the
presence of Porcine Reproductive and
Respiratory Syndrome Virus (PRRSV) in
groups of swine in buildings where a
respiratory disease outbreak is
diagnosed.
*
*
*
*
*
■
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
§ 528.2010 Human lysosomal acid lipase
recombinant deoxyribonucleic acid
construct.
24. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 522.56
[Amended]
25. In § 522.56, in paragraph (b),
remove ‘‘000859’’ and in its place add
‘‘069043’’.
■
§ 522.390
[Amended]
26. In § 522.390, in paragraph (b),
remove ‘‘Nos. 000859 and 054771’’ and
in its place add ‘‘Nos. 054771 and
069043’’.
■
§ 522.540
[Amended]
27. In § 522.540, in paragraph (e)(2),
remove ‘‘000859’’ and in its place add
‘‘069043’’.
■
§ 522.810
[Amended]
28. In § 522.810, in paragraph (b),
remove ‘‘000859’’ and in its place add
‘‘069043’’.
■
§ 522.1066
[Amended]
30. In § 520.1662a, in paragraphs
(b)(3)(i)(b), (c)(3)(i), (d)(3)(i)(a),
(e)(3)(i)(b), (g)(3)(i)(b), and (k)(3)(ii),
remove ‘‘Hemophilus’’ and in its place
add ‘‘Haemophilus’’.
asabaliauskas on DSK3SPTVN1PROD with RULES
■
[Amended]
31. In § 522.2260, in paragraph (b),
remove ‘‘000010’’ and in its place add
‘‘016592’’.
■
VerDate Sep<11>2014
16:23 Mar 29, 2016
§ 524.1044g
[Amended]
33. In § 522.1044g, in paragraph (b)(3),
remove ‘‘000859’’ and in its place add
‘‘069043’’.
■
PART 528—NEW ANIMAL DRUGS IN
GENETICALLY ENGINEERED
ANIMALS
34. The authority citation for 21 CFR
part 528 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
35. Add § 528.2010 to read as follows:
(a) Specifications. A single copy of a
human lysosomal acid lipase (hLAL)
recombinant deoxyribonucleic acid
(rDNA) gene construct located at the
SYN LAL–C site in chromosome 6 in a
specific, diploid line (SBC LAL–C) of
hemizygous and homozygous domestic
chickens (Gallus gallus), derived from
the lineage progenitor XLL 109.
(b) Sponsor. See No. 069334 in
§ 510.600 of this chapter.
(c) Conditions of use—(1) Intended
use. The gene construct directs the
expression of that encoding gene such
that recombinant, human lysosomal
acid lipase (rhLAL) protein intended for
the treatment of human disease is
present in SBC LAL–C chicken egg
whites.
(2) Limitations. Food or feed from
XLL 109 chickens is not permitted in
the food or feed supply.
36. The authority citation for 21 CFR
part 529 continues to read as follows:
Jkt 238001
Authority: 21 U.S.C. 360b.
■
37. Add § 529.539 to read as follows:
§ 529.539
Dexmedetomidine.
(a) Specifications. Each milliliter of
gel contains 0.09 milligrams (mg)
dexmedetomidine (equivalent to 0.1 mg
dexmedetomidine hydrochloride).
(b) Sponsor. See No. 052483 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
Administer onto the oral mucosa
between the dog’s cheek and gum at a
dose of 125 micrograms per square
meter.
PO 00000
Frm 00008
Fmt 4700
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PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
38. The authority citation for 21 CFR
part 556 continues to read as follows:
■
Authority: 21 U.S.C. 342, 360b, 371.
39. In § 556.70, in paragraph (b),
remove ‘‘methylene disalicylate’’ and in
its place add ‘‘methylenedisalicylate’’;
and add paragraph (c) to read as follows:
■
§ 556.70
Bacitracin.
*
■
[Amended]
29. In § 522.1066, in paragraph (b),
remove ‘‘Nos. 000859 and 054771’’ and
in its place add ‘‘Nos. 054771 and
069043’’.
§ 522.2260
Authority: 21 U.S.C. 360b.
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
■
§ 522.1662a
32. The authority citation for 21 CFR
part 524 continues to read as follows:
(2) Indications for use. For the
treatment of noise aversion in dogs.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
*
*
*
*
(c) Related conditions of use. See
§§ 520.154a, 520.154c, 558.76, and
558.78 of this chapter.
■ 40. In § 556.283, revise paragraphs
(b)(3) and (4) to read as follows:
§ 556.283
Florfenicol.
*
*
*
*
*
(b) * * *
(3) Freshwater-reared finfish (other
than catfish) and salmonids. The
tolerance for florfenicol amine (the
marker residue) in muscle/skin (the
target tissues) is 1 ppm.
(4) Catfish. The tolerance for
florfenicol amine (the marker residue) in
muscle (the target tissues) is 1 ppm.
*
*
*
*
*
§ 556.690
[Removed]
41. Remove § 556.690.
42. In § 556.765, revise paragraph
(b)(1)(i) and add paragraphs (b)(1)(ii)
and (c) to read as follows:
■
■
§ 556.765
Zilpaterol.
*
*
*
*
*
(b) * * *
(1) * * *
(i) Liver (the target tissue). The
tolerance for zilpaterol (the marker
residue) is 12 parts per billion (ppb).
(ii) Muscle. The tolerance for
zilpaterol (the marker residue) is 10
ppb.
*
*
*
*
*
(c) Related conditions of use. See
§ 558.665 of this chapter.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
43. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
§ 558.4
[Amended]
44. In § 558.4, in paragraph (d), in the
‘‘Category I’’ table, in the ‘‘Drug’’
■
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Federal Register / Vol. 81, No. 61 / Wednesday, March 30, 2016 / Rules and Regulations
column, remove ‘‘Bacitracin methylene
disalicylate’’ and in its place add ’’
Bacitracin methylenedisalicylate’’; and
in the ‘‘Category II’’ table, remove the
entries for ‘‘Ronnel’’ and
‘‘Sulfaethoxypyridazine’’.
§ 558.55
[Amended]
45. In § 558.55, in paragraph (d)(2)(ii),
in the ‘‘Combination in grams per ton’’
and ‘‘Limitations’’ columns, remove
‘‘methylene disalicylate’’ and in its
place add ‘‘methylenedisalicylate’’.
■
§ 558.58
[Amended]
46. In § 558.58, in paragraph (e)(4), in
the ‘‘Limitations’’ column, remove
‘‘methylene disalicylate’’ and in its
place add ‘‘methylenedisalicylate’’.
■
§ 558.68
[Amended]
47. In § 558.68, remove paragraph
(e)(3).
■ 48. In § 558.76, remove paragraph
(e)(2), redesignate paragraph (e)(3) as
paragraph (e)(2), and revise redesignated
paragraph (e)(2) to read as follows:
■
§ 558.76
Bacitracin methylenedisalicylate.
*
*
*
*
*
(e) * * *
(2) Bacitracin methylenedisalicylate
may also be used in combination with:
(i) Amprolium as in § 558.55.
(ii) Amprolium and ethopabate as in
§ 558.58.
(iii) Clopidol as in § 558.175.
(iv) Decoquinate as in § 558.195.
(v) Diclazuril as in § 558.198.
(vi) Fenbendazole as in § 588.258.
(vii) Halofuginone hydrobromide as in
§ 558.265.
(viii) Ivermectin as in § 558.300.
(ix) Lasalocid as in § 558.311.
(x) Monensin as in § 588.355.
(xi) Narasin as in § 558.363.
(xii) Nicarbazin alone and with
narasin as in § 558.366.
(xiii) Robenidine as in § 558.515.
(xiv) Salinomycin as in § 558.550.
(xv) Semduramicin as in § 558.555.
(xvi) Zoalene as in § 558.680.
§ 558.128
[Amended]
49. In § 558.128, in paragraph
(e)(7)(ii), remove ‘‘methylene
disalicylate’’ and in its place add
‘‘methylenedisalicylate’’.
■
§ 558.175
[Amended]
50. In § 558.175, in paragraph (d)(2),
in the ‘‘Combination in grams per ton’’
and ‘‘Limitations’’ columns, remove
‘‘methylene disalicylate’’ and in its
place add ‘‘methylenedisalicylate’’.
asabaliauskas on DSK3SPTVN1PROD with RULES
■
§ 558.195
[Amended]
51. In § 558.195, in paragraph
(e)(1)(ii), in the ‘‘Combination in grams/
ton’’ and ‘‘Limitations’’ columns,
■
VerDate Sep<11>2014
16:23 Mar 29, 2016
Jkt 238001
remove ‘‘methylene disalicylate’’ and in
its place add ‘‘methylenedisalicylate’’.
§ 558.198
[Amended]
52. In § 558.198, in paragraphs
(d)(1)(ii) and (d)(2)(ii), in the
‘‘Combination grams/ton’’ and
‘‘Limitations’’ columns, remove
‘‘methylene disalicylate’’ and in its
place add ‘‘methylenedisalicylate’’.
17609
‘‘Combination in grams per ton’’ and
‘‘Limitations’’ columns, remove
‘‘methylene disalicylate’’ and in its
place add ‘‘methylenedisalicylate’’.
■
§ 558.258
[Amended]
53. In § 588.258, in paragraphs
(e)(2)(vi) and (vii), in the ‘‘Combination
in grams per ton’’ and ‘‘Limitations’’
columns, remove ‘‘methylene
disalicylate’’ and in its place add
‘‘methylenedisalicylate’’.
■ 54. In § 558.261, redesignate
paragraphs (c)(2)(i) and (ii) as
paragraphs (c)(2)(ii) and (i),
respectively, revise redesignated
paragraph (c)(2)(ii), and add paragraph
(c)(4) to read as follows:
■
§ 558.261
Florfenicol.
*
*
*
*
*
(c) * * *
(2) * * *
(ii) For fish must not exceed 6 months
from the date of issuance.
*
*
*
*
*
(4) Type A medicated articles and
medicated feeds intended for use in fish
shall bear the following: ‘‘Not for use in
animals intended for breeding purposes.
The effects of florfenicol on
reproductive performance have not been
determined. Toxicity studies in dogs,
rats, and mice have associated the use
of florfenicol with testicular
degeneration and atrophy.’’
*
*
*
*
*
§ 558.265
[Amended]
§ 558.355
[Amended]
58. In § 558.355, in paragraphs
(f)(1)(iii)(b), (f)(1)(xxiv), (f)(1)(xxix)
introductory text, (f)(1)(xxix)(b),
(f)(1)(xxx) introductory text,
(f)(1)(xxx)(b), (f)(2)(ii) introductory text,
(f)(2)(ii)(b), (f)(2)(iii) introductory text,
(f)(2)(iii)(a), (f)(2)(iii)(b), (f)(4)(ii)
introductory text, (f)(4)(ii)(b), (f)(4)(iii)
introductory text, (f)(4)(iii)(b), (f)(4)(v)
introductory text, and (f)(4)(v)(b),
remove ‘‘methylene disalicylate’’ and in
its place add ‘‘methylenedisalicylate’’.
■
§ 558.363
[Amended]
59. In § 558.363, in paragraphs
(d)(1)(iv) introductory text, (d)(1)(iv)(B),
and (d)(3)(ii), remove ‘‘methylene
disalicylate’’ and in its place add
‘‘methylenedisalicylate’’.
■
§ 558.366
[Amended]
60. In § 558.366, in paragraph (d), in
the ‘‘Combination in grams per ton’’ and
‘‘Limitations’’ columns, remove
‘‘methylene disalicylate’’ wherever it
occurs and in its place add
‘‘methylenedisalicylate’’.
■
§ 558.450
[Amended]
61. In § 558.450, in paragraph
(d)(5)(v), in the ‘‘Indications for Use’’
column, remove ‘‘Hemophilus’’ and in
its place add ‘‘Haemophilus’’.
■
§ 558.515
[Amended]
62. In § 558.515, in paragraph (d), in
the ‘‘Combination in grams per ton’’ and
‘‘Limitations’’ columns, remove
‘‘methylene disalicylate’’ wherever it
occurs and in its place add
‘‘methylenedisalicylate’’.
■
55. In § 558.265, in paragraphs
(d)(1)(vi) and (d)(2)(ii), remove
‘‘methylene disalicylate’’ and in its
place add ‘‘methylenedisalicylate’’.
§ 558.550
§ 558.300
■
■
[Amended]
56. In § 558.300, in paragraphs (e)(2)
and (3), in the ‘‘Combination in g/ton of
feed’’ column, remove ‘‘methylene
disalicylate’’ and in its place add
‘‘methylenedisalicylate’’; and in
paragraph (e)(9), in the ‘‘Combination in
g/ton of feed ’’ and ‘‘Limitations’’
columns, remove ‘‘methylene
disalicylate’’ and in its place add
‘‘methylenedisalicylate’’.
■
§ 558.311
[Amended]
57. In § 558.311, in paragraphs
(e)(1)(iv) and (x), in the ‘‘Limitations’’
column, remove ‘‘methylene
disalicylate’’ and in its place add
‘‘methylenedisalicylate’’; and in
paragraph (e)(1)(xv), in the
■
PO 00000
[Amended]
63. In § 558.550, in paragraphs
(d)(1)(iii)(a), (d)(1)(iii)(c), (d)(1)(vi)(a),
(d)(1)(xx)(A), (d)(1)(xx)(C),
(d)(1)(xxi)(A), (d)(1)(xxi)(C), (d)(3)(ii)
introductory text, (d)(3)(ii)(B), (d)(3)(iii)
introductory text, (d)(3)(iii)(B), (d)(3)(v)
introductory text, and (d)(3)(v)(B),
remove ‘‘methylene disalicylate’’ and in
its place add ‘‘methylenedisalicylate’’;
and in paragraph (d)(1)(vi)(c), remove
‘‘Bacitracin MD’’ and in its place add
‘‘Bacitracin methylenedisalicylate’’.
Frm 00009
Fmt 4700
Sfmt 4700
§ 558.555
[Amended]
64. In § 558.555, in paragraph (d)(2),
in the ‘‘Combination in grams per ton’’
and ‘‘Limitations’’ columns, remove
‘‘methylene disalicylate’’ and in its
place add ‘‘methylenedisalicylate’’.
■
E:\FR\FM\30MRR1.SGM
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§ 558.680
Federal Register / Vol. 81, No. 61 / Wednesday, March 30, 2016 / Rules and Regulations
Dated: March 25, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. 2016–07135 Filed 3–29–16; 8:45 am]
BILLING CODE 4161–01–P
NATIONAL ARCHIVES AND RECORDS
ADMINISTRATION
36 CFR Part 1258
[FDMS No. NARA–16–0003; NARA–2016–
018]
RIN 3095–AB90
Fees
National Archives and Records
Administration (NARA).
ACTION: Direct final rule.
AGENCY:
The National Archives and
Records Administration (NARA) is
making a minor administrative revision
to its fees regulation to set a time limit
for requesting refunds of reproduction
fees.
DATES: This rule is effective April 29,
2016, without further action, unless
NARA receives adverse comments by
April 19, 2016. If NARA receives an
adverse comment, it will publish a
timely withdrawal of the rule in the
Federal Register.
ADDRESSES: You may submit comments,
identified by RIN 3095–AB90, by any of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Email: Regulation_comments@
nara.gov. Include RIN 3095–AB90 in the
subject line of the message.
• Fax: 301–837–0319. Include RIN
3095–AB90 in the subject line of the fax
cover sheet.
• Mail (for paper, disk, or CD–ROM
submissions. Include RIN 3095–AB90
on the submission): Regulations
Comment Desk (External Policy
Program, Strategy & Performance
Division (SP)); Suite 4100; National
Archives and Records Administration;
8601 Adelphi Road; College Park, MD
20740–6001
asabaliauskas on DSK3SPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
16:23 Mar 29, 2016
Jkt 238001
• Hand delivery or courier: Deliver
comments to front desk at the address
above.
Instructions: All submissions must
include NARA’s name and the
regulatory information number for this
rulemaking (RIN 3095–AB90). We may
publish any comments we receive
without changes, including any
personal information you include.
FOR FURTHER INFORMATION CONTACT:
Kimberly Keravuori, by email at
regulation_comments@nara.gov, or by
telephone at 301–837–3151.
SUPPLEMENTARY INFORMATION:
years after the customer received the
reproduction not only is not reasonable,
but occurs four years after we destroyed
records of the order, making it
impossible for us to determine if the
customer was notified and approved the
reproduction, whether there really was
an error or something incorrect about
the order, and similar issues.
As a result of these difficulties with
refund requests on old orders, we are
now revising 36 CFR 1258.16 to set a
refund time limit. Customers will have
four months from the order date in
which to request a refund.
Background
[Amended]
65. In § 558.680, in paragraphs
(d)(1)(ii), (iii), (iv), (vi), (vii), and (viii)
in the ‘‘Combination in grams per ton’’
and ‘‘Limitations’’ columns, remove
‘‘methylene disalicylate’’ and in its
place add ‘‘methylenedisalicylate’’; and
in paragraph (d)(2)(ii), in the
‘‘Combination in grams per ton’’
column, remove ‘‘methylene
disalicylate’’ and in its place add
‘‘methylenedisalicylate’’.
■
Regulatory Analysis
NARA is authorized by 44 U.S.C.
2116(c) to charge reproduction fees
when it reproduces documents for nonFederal individuals or entities. This
includes official reproductions with the
Archives seal, reproductions of archival
holdings, and reproductions of
operational records. The statute
authorizes NARA to recoup its costs,
equipment fees, and similar expenses,
and to retain the fees as part of the
National Archives Trust Fund. NARA
promulgated regulations at 36 CFR 1258
to notify users of the fee structure and
processes. Among these regulations is a
section addressing refunds of these fees
(36 CFR 1258.16). It is this provision
that we are revising with this
rulemaking.
Due to various factors, it is
occasionally difficult for us to make a
legible reproduction, particularly of old
documents. We notify customers if we
anticipate the reproduction will have
questionable legibility, and request the
customer’s approval to proceed with the
reproduction—and the fee charges. As a
result, we do not provide refunds except
in special cases; primarily if we have
somehow processed an order incorrectly
or it contains errors. However, the
regulation’s refund provision did not
include a refund cut-off period after
which a person who ordered a
reproduction could no longer request a
refund. Customers could request
refunds for orders that were years old,
which has occurred in several instances.
We had no recourse but to process the
refunds, which is not a reasonable
business practice for orders that are
multiple years old. This also caused a
significant administrative burden, as
NARA had discarded records for some
of these orders at the end of their
routine business life, in accord with our
agency’s official records schedule. For
example, under records schedule 1807–
2, orders made on our online ordering
system (SOFA) are destroyed once they
are one year old. A refund request five
Review Under Executive Orders 12866
and 13563
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
Executive Order 12866, Regulatory
Planning and Review, 58 FR 51735
(September 30, 1993), and Executive
Order 13563, Improving Regulation and
Regulation Review, 76 FR 23821
(January 18, 2011), direct agencies to
assess all costs and benefits of available
regulatory alternatives and, if regulation
is necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). This proposed rule is not
‘‘significant’’ under section 3(f) of
Executive Order 12866 because it
merely modifies the window of
opportunity in which customers may
request refunds of reproduction fees.
The Office of Management and Budget
(OMB) has reviewed this regulation.
Review Under the Regulatory
Flexibility Act (5 U.S.C. 601, et seq.)
This review requires an agency to
prepare an initial regulatory flexibility
analysis and publish it when the agency
publishes the proposed rule. This
requirement does not apply if the
agency certifies that the rule will not, if
promulgated, have a significant
economic impact on a substantial
number of small entities (5 U.S.C. 603).
NARA certifies, after review and
analysis, that this proposed rule will not
have a significant adverse economic
impact on small entities because it
merely modifies the window of
opportunity in which customers may
request refunds of reproduction fees.
Review Under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.)
This proposed rule does not contain
any information collection requirements
subject to the Paperwork Reduction Act.
E:\FR\FM\30MRR1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 61 (Wednesday, March 30, 2016)]
[Rules and Regulations]
[Pages 17604-17610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07135]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 528, 529, 556, and 558
[Docket No. FDA-2015-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Changes of Sponsorship
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect application-related actions for new animal
drug applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during November and December 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 changes of sponsorship of
applications that occurred in November and December 2015.
DATES: This rule is effective March 30, 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 November and December 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 November and December 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
File No. Sponsor Product name Action 21 CFR Section FOIA Summary NEPA Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-453.................. Alexion Pharmaceuticals, hLAL rDNA construct in Original approval for 528.2010 yes........... EA/
Inc., 33 Hayden Ave., SBC LAL-C chickens. expression of a human FONSI \1\
Lexington, MA 02421. gene for recombinant
human lysosomal acid
lipase (rhLAL) protein
in chicken egg whites.
141-456.................. Orion Corp., Orionintie SILEO (dexmedetomidine Original approval for 529.539 yes........... CE \2\ \3\
1, 02200 Espoo, Finland. oromucosal gel). the treatment of noise
aversion in dogs.
141-246.................. Intervet, Inc., 556 AQUAFLOR (florfenicol) Supplemental approval of 556.283, no............ CE \2\ \4\
Morris Ave., Summit, NJ Type A medicated revised representative 558.261
07901. article. labeling for Type C
medicated feeds;
technical amendments
revising the expiration
of veterinary feed
directives (VFDs) and
the description of
tolerances for fish.
[[Page 17605]]
141-258.................. Intervet, Inc., 556 ZILMAX (zilpaterol Supplemental approval of 556.765 yes........... CE \2\ \4\
Morris Ave., Summit, NJ hydrochloride) Type A a cattle muscle
07901. medicated article. tolerance and of new
determinative and
confirmatory procedures
for residues of
zilpaterol in cattle
liver and muscle.
141-361.................. Elanco Animal Health, A PULMOTIL AC (tilmicosin Supplemental approval 520.2471 yes........... EA/
Division of Eli Lilly & phosphate) Concentrate for the control of FONSI \1\
Co., Lilly Corporate Solution. swine respiratory
Center, Indianapolis, IN disease associated with
46285. Mycoplasma
hyopneumoniae in the
presence of Porcine
Reproductive and
Respiratory Syndrome
Virus (PRRSV).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
no significant impact (FONSI).
\2\ The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an
environmental impact statement because it is of a type that does not have a significant effect on the human environment.
\3\ CE granted under 21 CFR 25.33(d)(1).
\4\ CE granted under 21 CFR 25.33(a)(1).
II. Changes of Sponsorship
Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee
Mission, KS 66201 (Bayer) has informed FDA that it has transferred
ownership of, and all rights and interest in, the following approved
applications to Cronus Pharma LLC, 2 Tower Center Blvd., Suite 1101,
East Brunswick, NJ 08816:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
055-002...................... TEVCOSIN 522.390
(chloramphenicol)
Injectable Solution.
094-170...................... Phenylbutazone 520.1720a
Tablets, USP 100 mg
and 200 mg.
123-815...................... Dexamethasone Sodium 522.540
Phosphate Injection.
141-245...................... TRIBUTAME 522.810
(chloroquine
phosphate,
embutramid,
lidocaine)
Euthanasia Solution.
200-178...................... Amikacin Sulfate 522.56
Injection, 50 mg/mL.
200-193...................... Clindamycin 520.447
Hydrochloride Oral
Liquid.
200-248...................... Pyrantel Pamoate 520.2043
Suspension; 2.27 and
4.54 mg.
200-265...................... Praziquantel Tablets. 520.1870
200-287...................... GBC (Gentamicin 524.1044g
Sulfate
Betamethasone
Valerate
Clotrimazole)
Ointment.
200-297...................... Ivermectin Chewable 520.1193
Tablets.
200-298...................... Clindamycin 520.446
Hydrochloride
Capsules.
200-365...................... ROBINUL-V 522.1066
(glycopyrrolate)
Injectable Solution.
200-382...................... Furosemide Syrup 1%.. 520.1010
------------------------------------------------------------------------
Bayer has also informed FDA that it has transferred ownership of,
and all rights and interest in, approved ANADA 200-342 for Pyrantel
Pamoate Paste to Farnam Companies, Inc., 301 West Osborn Rd., Phoenix,
AZ 85013-3928.
Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Hwy., St.
Joseph, MO 64506-2002 has informed FDA that it has transferred
ownership of, and all rights and interest in, the following approved
applications to Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113
Sofia, Bulgaria:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
006-084 \1\.................. SULMET 520.2261a
(sulfamethazine)
Drinking Water
Solution.
008-774...................... SULMET 522.2260
(sulfamethazine)
Injectable Solution.
033-373 \1\.................. VETSULID 520.2200
(sulfachlorpyridazin
e).
040-181 \1\.................. VETSULID 520.2200
(sulfachlorpyridazin
e) Oral Suspension.
055-012 \1\.................. CHLORONEX SULMET 520.445
(chlortetracycline
bisulfate/
sulfamethazine
bisulfate) Soluble
Powder.
055-018 \1\.................. AUREOMYCIN 520.443
(chlortetracycline
HCl) Tablets 25 mg.
055-039 \1\.................. AUREOMYCIN 520.443
(chlortetracycline
HCl) Soluble Oblets.
065-071 \1\.................. AUREOMYCIN 520.441
(chlortetracycline
HCl) Soluble Powder.
065-269 \1\.................. POLYOTIC 520.2345d
(tetracycline
hydrochloride)
Soluble Powder.
065-440 \1\.................. CHLORONEX 520.441
(chlortetracycline
HCl or
chlortetracycline
bisulfate) Soluble
Powder.
122-271 \1\.................. SULMET 520.2260a
(sulfamethazine)
Oblets.
122-272 \1\.................. SULMET 520.2261b
(sulfamethazine
sodium) Soluble
Powder.
------------------------------------------------------------------------
\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.
[[Page 17606]]
In addition, Novartis Animal Health US, Inc., 3200 Northline Ave.,
suite 300, Greensboro, NC 27408 (Novartis) has informed FDA that it has
transferred ownership of, and all rights and interest in, the following
approved applications to Elanco US, Inc., 2500 Innovation Way,
Greenfield, IN 46140.
------------------------------------------------------------------------
File No. Product name
------------------------------------------------------------------------
134-644...................... DENAGARD (tiamulin) Soluble Powder.
139-472...................... DENAGARD (tiamulin) Type B Medicated
Feed.
140-915...................... INTERCEPTOR (milbemycin oxime) Tablets.
140-916...................... DENAGARD (tiamulin) Liquid Concentrate.
141-011...................... DENAGARD (tiamulin) plus CTC
(chlortetracycline).
141-026...................... PROGRAM (lufenuron) Suspension.
141-029...................... PERCORTEN-V (desoxycorticosterone
pivalate) Injectable Suspension.
141-035...................... PROGRAM (lufenuron).
141-062...................... PROGRAM (lufenuron) Cat Flavor Tabs.
141-084...................... SENTINEL (lufenuron and milbemycin oxime)
Flavor Tabs.
141-105...................... PROGRAM (lufenuron) 6-Month Injectable
for Cats.
141-120...................... CLOMICALM (clomipramine) Tablets.
141-163...................... MILBEMITE (milbemycin oxime) Otic
Solution.
141-175...................... CAPSTAR (nitenpyram) Tablets.
141-203...................... DERAMAXX (deracoxib) Chewable Tablets.
141-204...................... SENTINEL Flavor Tabs and CAPSTAR Flea
Management System.
141-205...................... PROGRAM Flavor Tabs and CAPSTAR Flea
Management System.
141-218...................... ATOPICA (cyclosporine) Capsules.
141-320...................... ONSIOR (robenacoxib) Tablets.
141-329...................... ATOPICA (cyclosporine) Oral Solution for
Cats.
141-333...................... SENTINEL SPECTRUM (milbemycin oxime,
lufenuron, praziquantel) Chewable
Tablets.
141-338...................... INTERCEPTOR SPECTRUM (milbemycin oxime
and praziquantel) Chewable Tablets.
141-437...................... OSURNIA (florfenicol, betamethasone
acetate, and terbinafine) Otic Gel.
141-443...................... ONSIOR (robenacoxib) Injection.
200-517...................... ZOBUXA (enrofloxacin) Tablets.
200-519...................... FLORVIO (florfenicol) 2.3% Concentrate
Solution.
------------------------------------------------------------------------
As provided in the regulatory text of this document, the animal
drug regulations are amended to reflect these changes of sponsorship.
Elanco US, Inc., is retaining Novartis' drug labeler code (058198).
Accordingly, the animal drug regulations need only be amended in Sec.
510.600(c) to add Elanco US, Inc., who previously was not the sponsor
of an approved application. Cronus Pharma LLC will also be added as a
new listing. Following these changes of sponsorship, Novartis is no
longer the sponsor of an approved application and will be removed from
Sec. 510.600(c).
III. Technical Amendments
FDA has noticed the animal drug regulations in 21 CFR part 556
contain tolerances for residues in edible tissues for sulfathiazole,
which is no longer the subject of an approved application (79 FR 15540,
March 20, 2014). Accordingly, Sec. 556.690 is being removed. FDA has
also noticed that the animal drug regulations in 21 CFR 558.4 (Sec.
558.4) contain assay limits for ronnel and sulfaethoxypyridazine in
medicated feed. As there is no longer an approved application for use
of either of these drugs in medicated feed, the table for Category II
drugs in Sec. 558.4 is being amended to remove assay limits in
medicated feed for both drugs. These actions are being taken to improve
the accuracy of the regulations.
In addition, FDA is taking this opportunity to revise the spelling
of a bacitracin salt to a preferred form, bacitracin
methylenedisalicylate, and to correct the spelling of a genus of
pathogenic bacteria, Haemophilus. These actions are 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, 524, 528, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
520, 522, 524, 528, 529, 556, 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.
Sec. 510.600 [Amended]
0
2. In Sec. 510.600, in the table in paragraph (c)(1), remove the entry
for ``Novartis Animal Health US, Inc.'' and add entries for ``Cronus
Pharma LLC'' and ``Elanco US, Inc.'' in alphabetical order; and in the
table in paragraph (c)(2), revise the entry for ``058198'' and add an
entry for ``069043'' in numerical order to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
[[Page 17607]]
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * * * *
Cronus Pharma LLC, 2 Tower Center Blvd., 069043
Suite 1101, East Brunswick, NJ 08816.
* * * * * * *
Elanco US, Inc., 2500 Innovation Way, 058198
Greenfield, IN 46140.
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
058198............................ Elanco US, Inc., 2500 Innovation
Way, Greenfield, IN 46140
* * * * * * *
069043............................ Cronus Pharma LLC, 2 Tower Center
Blvd., Suite 1101, East Brunswick,
NJ 08816
* * * * * * *
------------------------------------------------------------------------
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.88b [Amended]
0
4. In Sec. 520.88b, in paragraph (b)(1)(ii)(B), remove ``Hemophilus''
and in its place add ``Haemophilus''.
0
5. In Sec. 520.154b:
0
a. Revise the section heading.
0
b. In paragraph (a), remove ``methylene disalicylate'' and in its place
add ``methylenedisalicylate''.
The revision reads as follows:
Sec. 520.154b Bacitracin methylenedisalicylate and streptomycin
sulfate powder.
* * * * *
Sec. 520.441 [Amended]
0
6. In Sec. 520.441, in paragraphs (b)(2) and (d)(4)(iii)(C), remove
``000010'' and in its place add ``016592''; and in in paragraphs
(d)(1)(i)(A)(1), (d)(2)(i)(A)(1), (d)(4)(iii)(B), and (d)(4)(iv)(B),
remove ``Hemophilus'' and in its place add ``Haemophilus''.
Sec. 520.443 [Amended]
0
7. In Sec. 520.443, in paragraph (b), remove ``No. 054628'' and in its
place add ``Nos. 016592 and 054628''; and in paragraphs (d)(1)(i),
(d)(2)(i), and (d)(3)(i), remove ``Hemophilus'' and in its place add
``Haemophilus''.
Sec. 520.445 [Amended]
0
8. In Sec. 520.445, in paragraph (b), remove ``000010'' and in its
place add ``016592''.
Sec. 520.446 [Amended]
0
9. In Sec. 520.446, in paragraph (b)(1), remove ``No. 054771'' and in
its place add ``Nos. 054771 and 069043''.
Sec. 520.447 [Amended]
0
10. In Sec. 520.447, in paragraph (b), remove ``Nos. 000859, 051311,
054771, 058829, and 061623'' and in its place add ``Nos. 051311,
054771, 058829, 061623, and 069043''.
Sec. 520.823 [Amended]
0
11. In Sec. 520.823, in paragraph (d)(2)(ii), remove ``Hemophilus''
and in its place add ``Haemophilus''.
Sec. 520.1010 [Amended]
0
12. In Sec. 520.1010, in paragraph (b)(3), remove ``Nos. 000859 and
058829'' and in its place add ``Nos. 058829 and 069043''.
Sec. 520.1193 [Amended]
0
13. In Sec. 520.1193, in paragraph (b)(2), remove ``Nos. 000859 and
051311'' and in its place add ``Nos. 051311 and 069043''.
Sec. 520.1720a [Amended]
0
14. In Sec. 520.1720a, in paragraph (b)(2), remove ``Nos. 000859 and
054628'' and in its place add ``Nos. 054628 and 069043''.
0
15. In Sec. 520.1870, revise paragraph (b) to read as follows:
Sec. 520.1870 Praziquantel tablets.
* * * * *
(b) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter for
use of the product described in paragraph (a)(1) of this section as in
paragraph (c)(1) of this section; and for use of the product described
in paragraph (a)(2) of this section as in paragraph (c)(2) of this
section.
* * * * *
Sec. 520.2043 [Amended]
0
16. In Sec. 520.2043, in paragraph (b)(1), remove ``Nos. 000859,
054771, and 058829'' and in its place add ``Nos. 054771, 058829, and
069043''.
Sec. 520.2044 [Amended]
0
17. In Sec. 520.2044, in paragraph (b)(2), remove ``000859'' and in
its place add ``017135''.
Sec. 520.2200 [Amended]
0
18. In Sec. 520.2200, in paragraph (b), remove ``000010'' and in its
place add ``016592''.
Sec. 520.2260a [Amended]
0
19. In Sec. 520.2260a, in paragraph (a)(1), remove ``000010'' and in
its place add ``016592''.
Sec. 520.2261a [Amended]
0
20. In Sec. 520.2261a, in paragraph (b), remove ``000010'' and in its
place add ``016592''.
Sec. 520.2261b [Amended]
0
21. In Sec. 520.2261b, in paragraph (b), remove ``000010'' and in its
place add ``016592''.
Sec. 520.2345d [Amended]
0
22. In Sec. 520.2345d, in paragraphs (b)(5), (d)(1)(iii), and
(d)(2)(iii), remove ``000010'' and in its place add ``016592''; and in
paragraphs (d)(1)(ii) and (d)(2)(ii), remove ``Hemophilus'' and in its
place add ``Haemophilus''.
[[Page 17608]]
0
23. In Sec. 520.2471, revise paragraph (d)(2) to read as follows:
Sec. 520.2471 Tilmicosin.
* * * * *
(d) * * *
(2) Indications for use--(i) For the control of swine respiratory
disease associated with Pasteurella multocida and Haemophilus parasuis
in groups of swine in buildings where a respiratory disease outbreak is
diagnosed.
(ii) For the control of swine respiratory disease associated with
Mycoplasma hyopneumoniae in the presence of Porcine Reproductive and
Respiratory Syndrome Virus (PRRSV) in groups of swine in buildings
where a respiratory disease outbreak is diagnosed.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
24. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.56 [Amended]
0
25. In Sec. 522.56, in paragraph (b), remove ``000859'' and in its
place add ``069043''.
Sec. 522.390 [Amended]
0
26. In Sec. 522.390, in paragraph (b), remove ``Nos. 000859 and
054771'' and in its place add ``Nos. 054771 and 069043''.
Sec. 522.540 [Amended]
0
27. In Sec. 522.540, in paragraph (e)(2), remove ``000859'' and in its
place add ``069043''.
Sec. 522.810 [Amended]
0
28. In Sec. 522.810, in paragraph (b), remove ``000859'' and in its
place add ``069043''.
Sec. 522.1066 [Amended]
0
29. In Sec. 522.1066, in paragraph (b), remove ``Nos. 000859 and
054771'' and in its place add ``Nos. 054771 and 069043''.
Sec. 522.1662a [Amended]
0
30. In Sec. 520.1662a, in paragraphs (b)(3)(i)(b), (c)(3)(i),
(d)(3)(i)(a), (e)(3)(i)(b), (g)(3)(i)(b), and (k)(3)(ii), remove
``Hemophilus'' and in its place add ``Haemophilus''.
Sec. 522.2260 [Amended]
0
31. In Sec. 522.2260, in paragraph (b), remove ``000010'' and in its
place add ``016592''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
32. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1044g [Amended]
0
33. In Sec. 522.1044g, in paragraph (b)(3), remove ``000859'' and in
its place add ``069043''.
PART 528--NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS
0
34. The authority citation for 21 CFR part 528 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
35. Add Sec. 528.2010 to read as follows:
Sec. 528.2010 Human lysosomal acid lipase recombinant
deoxyribonucleic acid construct.
(a) Specifications. A single copy of a human lysosomal acid lipase
(hLAL) recombinant deoxyribonucleic acid (rDNA) gene construct located
at the SYN LAL-C site in chromosome 6 in a specific, diploid line (SBC
LAL-C) of hemizygous and homozygous domestic chickens (Gallus gallus),
derived from the lineage progenitor XLL 109.
(b) Sponsor. See No. 069334 in Sec. 510.600 of this chapter.
(c) Conditions of use--(1) Intended use. The gene construct directs
the expression of that encoding gene such that recombinant, human
lysosomal acid lipase (rhLAL) protein intended for the treatment of
human disease is present in SBC LAL-C chicken egg whites.
(2) Limitations. Food or feed from XLL 109 chickens is not
permitted in the food or feed supply.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
36. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
37. Add Sec. 529.539 to read as follows:
Sec. 529.539 Dexmedetomidine.
(a) Specifications. Each milliliter of gel contains 0.09 milligrams
(mg) dexmedetomidine (equivalent to 0.1 mg dexmedetomidine
hydrochloride).
(b) Sponsor. See No. 052483 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer onto the oral mucosa
between the dog's cheek and gum at a dose of 125 micrograms per square
meter.
(2) Indications for use. For the treatment of noise aversion in
dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
38. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
39. In Sec. 556.70, in paragraph (b), remove ``methylene
disalicylate'' and in its place add ``methylenedisalicylate''; and add
paragraph (c) to read as follows:
Sec. 556.70 Bacitracin.
* * * * *
(c) Related conditions of use. See Sec. Sec. 520.154a, 520.154c,
558.76, and 558.78 of this chapter.
0
40. In Sec. 556.283, revise paragraphs (b)(3) and (4) to read as
follows:
Sec. 556.283 Florfenicol.
* * * * *
(b) * * *
(3) Freshwater-reared finfish (other than catfish) and salmonids.
The tolerance for florfenicol amine (the marker residue) in muscle/skin
(the target tissues) is 1 ppm.
(4) Catfish. The tolerance for florfenicol amine (the marker
residue) in muscle (the target tissues) is 1 ppm.
* * * * *
Sec. 556.690 [Removed]
0
41. Remove Sec. 556.690.
0
42. In Sec. 556.765, revise paragraph (b)(1)(i) and add paragraphs
(b)(1)(ii) and (c) to read as follows:
Sec. 556.765 Zilpaterol.
* * * * *
(b) * * *
(1) * * *
(i) Liver (the target tissue). The tolerance for zilpaterol (the
marker residue) is 12 parts per billion (ppb).
(ii) Muscle. The tolerance for zilpaterol (the marker residue) is
10 ppb.
* * * * *
(c) Related conditions of use. See Sec. 558.665 of this chapter.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
43. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
Sec. 558.4 [Amended]
0
44. In Sec. 558.4, in paragraph (d), in the ``Category I'' table, in
the ``Drug''
[[Page 17609]]
column, remove ``Bacitracin methylene disalicylate'' and in its place
add '' Bacitracin methylenedisalicylate''; and in the ``Category II''
table, remove the entries for ``Ronnel'' and ``Sulfaethoxypyridazine''.
Sec. 558.55 [Amended]
0
45. In Sec. 558.55, in paragraph (d)(2)(ii), in the ``Combination in
grams per ton'' and ``Limitations'' columns, remove ``methylene
disalicylate'' and in its place add ``methylenedisalicylate''.
Sec. 558.58 [Amended]
0
46. In Sec. 558.58, in paragraph (e)(4), in the ``Limitations''
column, remove ``methylene disalicylate'' and in its place add
``methylenedisalicylate''.
Sec. 558.68 [Amended]
0
47. In Sec. 558.68, remove paragraph (e)(3).
0
48. In Sec. 558.76, remove paragraph (e)(2), redesignate paragraph
(e)(3) as paragraph (e)(2), and revise redesignated paragraph (e)(2) to
read as follows:
Sec. 558.76 Bacitracin methylenedisalicylate.
* * * * *
(e) * * *
(2) Bacitracin methylenedisalicylate may also be used in
combination with:
(i) Amprolium as in Sec. 558.55.
(ii) Amprolium and ethopabate as in Sec. 558.58.
(iii) Clopidol as in Sec. 558.175.
(iv) Decoquinate as in Sec. 558.195.
(v) Diclazuril as in Sec. 558.198.
(vi) Fenbendazole as in Sec. 588.258.
(vii) Halofuginone hydrobromide as in Sec. 558.265.
(viii) Ivermectin as in Sec. 558.300.
(ix) Lasalocid as in Sec. 558.311.
(x) Monensin as in Sec. 588.355.
(xi) Narasin as in Sec. 558.363.
(xii) Nicarbazin alone and with narasin as in Sec. 558.366.
(xiii) Robenidine as in Sec. 558.515.
(xiv) Salinomycin as in Sec. 558.550.
(xv) Semduramicin as in Sec. 558.555.
(xvi) Zoalene as in Sec. 558.680.
Sec. 558.128 [Amended]
0
49. In Sec. 558.128, in paragraph (e)(7)(ii), remove ``methylene
disalicylate'' and in its place add ``methylenedisalicylate''.
Sec. 558.175 [Amended]
0
50. In Sec. 558.175, in paragraph (d)(2), in the ``Combination in
grams per ton'' and ``Limitations'' columns, remove ``methylene
disalicylate'' and in its place add ``methylenedisalicylate''.
Sec. 558.195 [Amended]
0
51. In Sec. 558.195, in paragraph (e)(1)(ii), in the ``Combination in
grams/ton'' and ``Limitations'' columns, remove ``methylene
disalicylate'' and in its place add ``methylenedisalicylate''.
Sec. 558.198 [Amended]
0
52. In Sec. 558.198, in paragraphs (d)(1)(ii) and (d)(2)(ii), in the
``Combination grams/ton'' and ``Limitations'' columns, remove
``methylene disalicylate'' and in its place add
``methylenedisalicylate''.
Sec. 558.258 [Amended]
0
53. In Sec. 588.258, in paragraphs (e)(2)(vi) and (vii), in the
``Combination in grams per ton'' and ``Limitations'' columns, remove
``methylene disalicylate'' and in its place add
``methylenedisalicylate''.
0
54. In Sec. 558.261, redesignate paragraphs (c)(2)(i) and (ii) as
paragraphs (c)(2)(ii) and (i), respectively, revise redesignated
paragraph (c)(2)(ii), and add paragraph (c)(4) to read as follows:
Sec. 558.261 Florfenicol.
* * * * *
(c) * * *
(2) * * *
(ii) For fish must not exceed 6 months from the date of issuance.
* * * * *
(4) Type A medicated articles and medicated feeds intended for use
in fish shall bear the following: ``Not for use in animals intended for
breeding purposes. The effects of florfenicol on reproductive
performance have not been determined. Toxicity studies in dogs, rats,
and mice have associated the use of florfenicol with testicular
degeneration and atrophy.''
* * * * *
Sec. 558.265 [Amended]
0
55. In Sec. 558.265, in paragraphs (d)(1)(vi) and (d)(2)(ii), remove
``methylene disalicylate'' and in its place add
``methylenedisalicylate''.
Sec. 558.300 [Amended]
0
56. In Sec. 558.300, in paragraphs (e)(2) and (3), in the
``Combination in g/ton of feed'' column, remove ``methylene
disalicylate'' and in its place add ``methylenedisalicylate''; and in
paragraph (e)(9), in the ``Combination in g/ton of feed '' and
``Limitations'' columns, remove ``methylene disalicylate'' and in its
place add ``methylenedisalicylate''.
Sec. 558.311 [Amended]
0
57. In Sec. 558.311, in paragraphs (e)(1)(iv) and (x), in the
``Limitations'' column, remove ``methylene disalicylate'' and in its
place add ``methylenedisalicylate''; and in paragraph (e)(1)(xv), in
the ``Combination in grams per ton'' and ``Limitations'' columns,
remove ``methylene disalicylate'' and in its place add
``methylenedisalicylate''.
Sec. 558.355 [Amended]
0
58. In Sec. 558.355, in paragraphs (f)(1)(iii)(b), (f)(1)(xxiv),
(f)(1)(xxix) introductory text, (f)(1)(xxix)(b), (f)(1)(xxx)
introductory text, (f)(1)(xxx)(b), (f)(2)(ii) introductory text,
(f)(2)(ii)(b), (f)(2)(iii) introductory text, (f)(2)(iii)(a),
(f)(2)(iii)(b), (f)(4)(ii) introductory text, (f)(4)(ii)(b),
(f)(4)(iii) introductory text, (f)(4)(iii)(b), (f)(4)(v) introductory
text, and (f)(4)(v)(b), remove ``methylene disalicylate'' and in its
place add ``methylenedisalicylate''.
Sec. 558.363 [Amended]
0
59. In Sec. 558.363, in paragraphs (d)(1)(iv) introductory text,
(d)(1)(iv)(B), and (d)(3)(ii), remove ``methylene disalicylate'' and in
its place add ``methylenedisalicylate''.
Sec. 558.366 [Amended]
0
60. In Sec. 558.366, in paragraph (d), in the ``Combination in grams
per ton'' and ``Limitations'' columns, remove ``methylene
disalicylate'' wherever it occurs and in its place add
``methylenedisalicylate''.
Sec. 558.450 [Amended]
0
61. In Sec. 558.450, in paragraph (d)(5)(v), in the ``Indications for
Use'' column, remove ``Hemophilus'' and in its place add
``Haemophilus''.
Sec. 558.515 [Amended]
0
62. In Sec. 558.515, in paragraph (d), in the ``Combination in grams
per ton'' and ``Limitations'' columns, remove ``methylene
disalicylate'' wherever it occurs and in its place add
``methylenedisalicylate''.
Sec. 558.550 [Amended]
0
63. In Sec. 558.550, in paragraphs (d)(1)(iii)(a), (d)(1)(iii)(c),
(d)(1)(vi)(a), (d)(1)(xx)(A), (d)(1)(xx)(C), (d)(1)(xxi)(A),
(d)(1)(xxi)(C), (d)(3)(ii) introductory text, (d)(3)(ii)(B),
(d)(3)(iii) introductory text, (d)(3)(iii)(B), (d)(3)(v) introductory
text, and (d)(3)(v)(B), remove ``methylene disalicylate'' and in its
place add ``methylenedisalicylate''; and in paragraph (d)(1)(vi)(c),
remove ``Bacitracin MD'' and in its place add ``Bacitracin
methylenedisalicylate''.
Sec. 558.555 [Amended]
0
64. In Sec. 558.555, in paragraph (d)(2), in the ``Combination in
grams per ton'' and ``Limitations'' columns, remove ``methylene
disalicylate'' and in its place add ``methylenedisalicylate''.
[[Page 17610]]
Sec. 558.680 [Amended]
0
65. In Sec. 558.680, in paragraphs (d)(1)(ii), (iii), (iv), (vi),
(vii), and (viii) in the ``Combination in grams per ton'' and
``Limitations'' columns, remove ``methylene disalicylate'' and in its
place add ``methylenedisalicylate''; and in paragraph (d)(2)(ii), in
the ``Combination in grams per ton'' column, remove ``methylene
disalicylate'' and in its place add ``methylenedisalicylate''.
Dated: March 25, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-07135 Filed 3-29-16; 8:45 am]
BILLING CODE 4161-01-P
