New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications, 74018-74021 [2014-29249]
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74018
R–2933
Federal Register / Vol. 79, No. 240 / Monday, December 15, 2014 / Rules and Regulations
Cape Canaveral, FL [Amended]
By removing the current boundaries and
adding the following:
Boundaries. Beginning at lat. 28°39′21″ N.,
long. 80°42′39″ W.; to lat. 28°41′33″ N., long.
80°35′25″ W.; thence 3 NM from and parallel
to the shoreline; to lat. 28°24′31″ N., long.
80°29′52″ W.; to lat. 28°25′01″ N., long.
80°37′59″ W.; to lat. 28°34′01″ N., long.
80°39′29″ W.; to the point of beginning.
R–2934
Cape Canaveral, FL [Amended]
By removing the current boundaries and
adding the following:
Boundaries. Beginning at lat. 28°49′11″ N.,
long. 80°50′44″ W.; to lat. 28°51′16″ N., long.
80°47′14″ W.; to lat. 28°51′16″ N., long.
80°42′29″ W.; thence 3 NM from and parallel
to the shoreline; to lat. 28°41′33″ N., long.
80°35′25″ W.; to lat. 28°39′21″ N., long.
80°42′39″ W.; to lat. 28°34′01″ N., long.
80°39′29″ W.; to lat. 28°25′01″ N., long.
80°37′59″ W.; to lat. 28°25′01″ N., long.
80°41′44″ W.; to lat. 28°31′21″ N., long.
80°43′49″ W.; to lat. 28°38′01″ N., long.
80°47′01″ W.; to the point of beginning,
excluding that airspace below 1,200 feet AGL
west of a line from lat. 28°31′21″ N., long.
80°43′49″ W.; to lat. 28°28′41″ N., long.
80°40′29″ W.; to lat. 28°25′01″ N., long.
80°40′29″ W.
R–2935
Cape Canaveral, FL [Amended]
By removing the current boundaries and
adding the following:
Boundaries. Beginning at lat. 28°47′21″ N.,
long. 81°04′59″ W.; to lat. 28°58′02″ N., long.
80°46′58″ W.; thence 3 NM from and parallel
to the shoreline; to lat. 28°51′16″ N., long.
80°42′29″ W.; to lat. 28°51′16″ N., long.
80°47′14″ W.; to lat. 28°49′11″ N., long.
80°50′44″ W.; to lat. 28°38′01″ N., long.
80°47′01″ W.; to lat. 28°31′21″ N., long.
80°43′49″ W.; to lat. 28°25′01″ N., long.
80°41′44″ W.; to lat. 28°24′31″ N., long.
80°29′52″ W.; thence 3 NM from and parallel
to the shoreline; to lat. 28°19′01″ N., long.
80°33′00″ W.; to lat. 28°19′01″ N., long.
80°46′29″ W.; to the point of beginning.
Issued in Washington, DC, on December 9,
2014.
Gary A. Norek,
Manager, Airspace Policy and Regulations
Group.
[FR Doc. 2014–29268 Filed 12–12–14; 8:45 am]
BILLING CODE 4910–13–P
Food and Drug Administration
21 CFR Parts 510, 520, 522, and 558
[Docket No. FDA–2014–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Change of
Sponsor; Withdrawal of Approval of
New Animal Drug Applications
Food and Drug Administration,
HHS.
Final rule, technical
amendment.
ACTION:
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval actions for new animal drug
applications (NADAs) and abbreviated
new animal drug applications
(ANADAs) during September and
October 2014. FDA is also informing the
public of the availability of summaries
of the basis of approval and of
environmental review documents,
where applicable. The animal drug
regulations are also being amended to
reflect a change of sponsorship of six
NADAs and four ANADAs, the
voluntary withdrawal of approval of an
ANADA, and a correcting amendment.
DATES: This rule is effective December
15, 2014, except for the amendment to
21 CFR 520.1660d, which is effective
December 26, 2014.
SUMMARY:
File No.
139–236
140–866
140–994
200–055
200–332
....................................
....................................
....................................
....................................
....................................
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.
FDA is
amending the animal drug regulations to
reflect approval actions for NADAs and
ANADAs during September and October
2014, as listed in table 1. In addition,
FDA is informing the public of the
availability, where applicable, of
documentation of environmental review
required under the National
Environmental Policy Act (NEPA) and,
for actions requiring review of safety or
effectiveness data, summaries of the
basis of approval (FOI Summaries)
under the Freedom of Information Act
(FOIA). These public documents may be
seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday. Persons with access to the
Internet may obtain these documents at
the CVM FOIA Electronic Reading
Room: https://www.fda.gov/AboutFDA/
CentersOffices/OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm. Marketing exclusivity and
patent information may be accessed in
FDA’s publication, Approved Animal
Drug Products Online (Green Book) at:
https://www.fda.gov/AnimalVeterinary/
Products/ApprovedAnimalDrug
Products/default.htm.
In addition, Lloyd, Inc., 604 W.
Thomas Ave., Shenandoah, IA 51601,
has transferred ownership of, and all
rights and interest in, the following
approved applications to Akorn Animal
Health, Inc., 1925 West Field Ct., Suite
300, Lake Forest, IL 60045.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
FOR FURTHER INFORMATION CONTACT:
Product name
21 CFR cite
ANASED (xylazine hydrochloride) Injectable Solution .................................................................
YOBINE (yohimbine hydrochloride) Injectable Solution ..............................................................
TOLAZINE (tolazine hydrochloride) Injectable Solution ..............................................................
VETAKET (ketamine hydrochloride) Injectable Solution .............................................................
BUTORPHIC (butorphanol tartrate) Injectable Solution ..............................................................
Bioniche Animal Health USA, Inc.,
119 Rowe Rd., Athens, GA 30601, has
transferred ownership of, and all rights
and interest in, the following approved
´
applications to Vetoquinol USA, Inc.,
4250 N. Sylvania Ave., Fort Worth, TX
76137.
tkelley on DSK3SPTVN1PROD with RULES
File No.
Product name
141–431 ....................................
200–266 ....................................
200–432 ....................................
FOLLTROPIN (follicle stimulating hormone) Injection .................................................................
BUTEQUINE (phenylbutazone) Paste .........................................................................................
NEXHA (hyaluronate sodium) Injection .......................................................................................
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17:02 Dec 12, 2014
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Fmt 4700
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522.2662
522.2670
522.2474
522.1222
522.246
E:\FR\FM\15DER1.SGM
21 CFR cite
15DER1
522.1002
520.1720c
522.1145
Federal Register / Vol. 79, No. 240 / Monday, December 15, 2014 / Rules and Regulations
In addition, Veterinary Service, Inc.
4100 Bangs Ave., Modesto, CA 95356,
has transferred ownership of, and all
rights and interest in, NADA 065–252
for STREP–SOL (streptomycin sulfate)
Oral Solution to Huvepharma AD, 5th
Floor, 3A Nikolay Haitov Str., 1113
Sofia, Bulgaria.
Also, Elanco Animal Health, Inc., A
Division of Eli Lilly & Co., Lilly
Corporate Center, Indianapolis, IN
46285, has transferred ownership of,
and all rights and interest in, NADA
141–272 for RECONCILE (fluoxetine
hydrochloride) Chewable Tablets to
Nexcyon Pharmaceuticals, Inc., 644
West Washington Ave., Madison, WI
53703.
At this time, the regulations are being
amended to reflect these changes of
sponsorship. Following these changes of
sponsorship, Akorn Animal Health, Inc.,
Nexcyon Pharmaceuticals, Inc., and
´
Vetoquinol USA, Inc. will now be the
sponsors of an approved application
while Bioniche Animal Health USA,
Inc. and Veterinary Service, Inc. will no
longer be the sponsors of an approved
application. Accordingly, 21 CFR
510.600(c) is being amended to reflect
these changes.
FDA is also amending the regulations
at 21 CFR 558.76 to remove a limitation
on the concentrations of bacitracin
methylene disalicyclate Type A
medicated articles that can be used to
manufacture medicated feed for quail.
In addition, FDA is removing reserved
21 CFR 558.105 for which there is no
entry. These actions are being taken to
improve the accuracy of the regulations.
´
Also, Vetoquinol N.-A., Inc., 2000
chemin Georges, Lavaltrie (PQ), Canada,
J5T 3S5, has requested that FDA
withdraw approval of ANADA 200–305
for Oxytetracycline Hydrochloride
Soluble Powder because the product is
no longer manufactured or marketed.
Note this ANADA was identified as
being affected by guidance for industry
74019
(GFI) #213, ‘‘New Animal Drugs and
New Animal Drug Combination
Products Administered in or on
Medicated Feed or Drinking Water of
Food-Producing Animals:
Recommendations for Drug Sponsors for
Voluntarily Aligning Product Use
Conditions with GFI #209,’’ December
2013.
Elsewhere in this issue of the Federal
Register, FDA gave notice that approval
of ANADA 200–305, and all
supplements and amendments thereto,
is withdrawn, effective December 26,
2014. As provided in the regulatory text
of this document, the animal drug
regulations are amended to reflect this
voluntary withdrawal of approval.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING SEPTEMBER AND OCTOBER 2014
NADA/
ANADA
Sponsor
New animal drug product
name
141–244 ......
Zoetis Inc., 333 Portage
St., Kalamazoo, MI
49007.
DRAXXIN (tulathromycin)
Injectable Solution.
141–430×3 ...
Phibro Animal Health
Corp., GlenPointe Centre East, 3d Floor, 300
Frank W. Burr Blvd.,
suite 21, Teaneck, NJ
07666.
Putney, Inc., One Monument Sq., suite 400,
Portland, ME 04101.
Putney, Inc., One Monument Sq., suite 400,
Portland, ME 04101.
Cross Vetpharm Group
Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland.
STAFAC (virginiamycin)
plus COBAN (monensin)
combination drug Type
C medicated feeds.
200–522 ......
200–540 ......
200–581 ......
Carprofen Sterile
Injectable Solution.
Meloxicam (meloxicam)
Solution for Injection.
FLUNAZINE (flunixin
meglumine) Equine
Paste.
21 CFR
sections
Action
FOIA
summary
NEPA
review
Supplemental approval for
treatment of bovine respiratory disease (BRD)
in suckling calves, dairy
calves, and veal calves.
Original approval for prevention of coccidiosis
and necrotic enteritis in
broiler chickens.
522.2630
yes ...............
CE1 2
558.355
yes ...............
CE1 4
Original approval as a generic copy of NADA
141–199.
Original approval as a generic copy of NADA
141–219.
Original approval as a generic copy of NADA
137–409.
522.304
yes ..............
CE1 5
522.1367
yes ..............
CE1 5
520.970
yes ...............
CE1 5
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)(5).
3 This application is affected by GFI #213, ‘‘New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated
Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with
GFI #209’’, December 2013.
4 CE granted under 21 CFR 25.33(a)(2).
5 CE granted under 21 CFR 25.33(a)(1).
List of Subjects
21 CFR Part 558
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21 CFR Part 510
Animal drugs, Animal feeds.
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Parts 520 and 522
Animal drugs.
VerDate Sep<11>2014
17:02 Dec 12, 2014
PART 510—NEW ANIMAL DRUGS
Jkt 235001
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, and 558 are
amended as follows:
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Fmt 4700
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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.
2. In § 510.600, in the table in
paragraph (c)(1), remove the entries for
‘‘Bioniche Animal Health USA, Inc.’’
and ‘‘Veterinary Service, Inc.’’ and
■
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15DER1
74020
Federal Register / Vol. 79, No. 240 / Monday, December 15, 2014 / Rules and Regulations
alphabetically add entries for ‘‘Akorn
Animal Health, Inc.’’, ‘‘Nexcyon
´
Pharmaceuticals, Inc.’’, and ‘‘Vetoquinol
USA, Inc.’’; and in the table in
paragraph (c)(2), remove the entries for
‘‘033008’’ and ‘‘064847’’ and
numerically add entries for ‘‘017030’’,
‘‘050929’’, and ‘‘053599’’ to read as
follows:
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (c) of this section.
(1) No. 000061 for use of products
described in paragraph (a).
(2) No. 061623 for use of the product
described in paragraph (a)(2).
(c) * * *
(1) Amount. 0.5 mg per pound of body
weight per day for up to 5 days.
*
*
*
*
*
§ 520.980
*
[Amended]
5. In paragraph (b) of § 520.980,
remove ‘‘000986’’ and in its place add
‘‘050929’’.
Drug labeler
code
*
*
*
Akorn Animal Health, Inc.,
1925 West Field Ct., suite
300, Lake Forest, IL 60045
*
*
*
*
Nexcyon Pharmaceuticals,
Inc., 644 West Washington
Ave., Madison, WI 53719 ..
*
*
*
*
´
Vetoquinol USA, Inc., 4250
N. Sylvania Ave., Fort
Worth, TX 76137 ...............
*
*
053599
§ 520.1660d
[Amended]
6. In § 520.1660d, remove paragraph
(b)(8); and in paragraphs (d)(1)(ii)(A)(3),
(d)(1)(ii)(B)(3), (d)(1)(ii)(C)(3), and
(d)(1)(iii)(C), remove ‘‘059320,’’.
■
§ 520.1720c
[Amended]
*
*
*
050929
7. In paragraph (b)(2) of § 520.1720c,
remove ‘‘064847’’ and in its place add
‘‘017030’’.
[Amended]
8. In paragraph (b) of § 520.2158,
remove ‘‘033008’’ and in its place add
‘‘016592’’.
017030
*
§ 520.2158
■
*
*
(2) * * *
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
9. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Firm name and address
Authority: 21 U.S.C. 360b.
§ 522.246
*
*
*
*
*
´
017030 ........ Vetoquinol USA, Inc., 4250 N.
Sylvania Ave., Fort Worth,
TX 76137.
*
*
*
*
*
050929 ........ Nexcyon Pharmaceuticals,
Inc., 644 West Washington
Ave., Madison, WI 53719.
*
*
*
*
*
053599 ........ Akorn Animal Health, Inc.,
1925 West Field Ct., suite
300, Lake Forest, IL 60045.
*
*
*
*
*
[Amended]
10. In paragraph (b)(3) of § 522.246,
remove ‘‘061690’’ and in its place add
‘‘053599’’.
■ 11. In § 522.304, revise paragraph (b)
to read as follows:
■
§ 522.304
Carprofen.
*
*
*
*
*
(b) Sponsors. See Nos. 026637,
054771, and 055529 in § 510.600(c) of
this chapter.
*
*
*
*
*
§ 522.1002
[Amended]
12. In paragraph (c)(2) of § 522.1002,
remove ‘‘064847’’ and in its place add
‘‘017030’’.
■
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for 21 CFR
part 520 continues to read as follows:
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■
§ 522.1145
[Amended]
4. In § 520.970, revise paragraphs (b)
and (c)(1) to read as follows:
13. In paragraph (e)(2)(ii) of
§ 522.1145, remove ‘‘064847’’ and in its
place add ‘‘017030’’.
■ 14. In § 522.1222, revise paragraph (b)
to read as follows:
§ 520.970
Flunixin.
§ 522.1222
Ketamine.
*
*
*
*
Authority: 21 U.S.C. 360b.
■
*
VerDate Sep<11>2014
Meloxicam.
*
*
*
*
*
(b) Sponsors. See Nos. 000010,
016729, 026637, and 055529 in
§ 510.600(c) of this chapter.
*
*
*
*
*
§ 522.2474
[Amended]
16. In paragraph (b) of § 522.2474,
remove ‘‘061690’’ and in its place add
‘‘053599’’.
■ 17. In § 522.2630, revise paragraph
(d)(1) to read as follows:
*
*
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*
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*
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§ 522.2630
Tulathromycin.
*
■
Drug labeler
code
§ 522.1367
■
Firm name and address
*
(b) Sponsors. See Nos. 000859,
026637, 053599, 054628, 054771, and
063286 in § 510.600(c) of this chapter.
*
*
*
*
*
■ 15. In § 522.1367, revise paragraph (b)
to read as follows:
*
*
*
*
(d) * * *
(1) Cattle—(i) Amount. 2.5 mg per
kilogram (/kg) body weight as a single
subcutaneous injection in the neck.
(ii) Indications for use—(A) Beef and
non-lactating dairy cattle; suckling
calves, dairy calves, and veal calves: For
the treatment of bovine respiratory
disease (BRD) associated with
Mannheimia haemolytica, Pasteurella
multocida, Histophilus somni, and
Mycoplasma bovis;
(B) Beef and non-lactating dairy
cattle: For the control of respiratory
disease in cattle at high risk of
developing BRD associated with M.
haemolytica, P. multocida, H. somni,
and M. bovis. For the treatment of
infectious bovine keratoconjunctivitis
associated with Moraxella bovis. For the
treatment of bovine foot rot (interdigital
necrobacillosis) associated with
Fusobacterium necrophorum and
Porphyromonas levii.
(iii) Limitations. Cattle intended for
human consumption must not be
slaughtered within 18 days from the last
treatment. Do not use in female dairy
cattle 20 months of age or older. Federal
law restricts this drug to use by or on
the order of a licensed veterinarian.
*
*
*
*
*
§ 522.2662
[Amended]
18. In paragraph (b)(4) of § 522.2662,
remove ‘‘061690’’ and in its place add
‘‘053599’’.
■ 19. Revise § 522.2670 to read as
follows:
■
§ 522.2670
Yohimbine.
(a) Specifications. Each milliliter (mL)
of solution contains 2 or 5 milligrams
(mg) of yohimbine (as hydrochloride).
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Federal Register / Vol. 79, No. 240 / Monday, December 15, 2014 / Rules and Regulations
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (c) of this section.
(1) No. 053599 for use of in 2 mg/mL
solution as in paragraph (c)(1) of this
section.
(2) No. 053923 for use of in 5 mg/mL
solution as in paragraph (c)(2) of this
section.
(c) Conditions of use—(1) Dogs—(i)
Amount. Administer 0.05 mg per pound
(0.11 mg per kilogram) of body weight
by intravenous injection.
(ii) Indications for use. To reverse the
effects of xylazine in dogs.
(iii) Limitations. Not for use in foodproducing animals. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) Deer and elk—(i) Amount.
Administer 0.2 to 0.3 mg per kilogram
of body weight by intravenous injection.
(ii) Indications for use. A s an
antagonist to xylazine sedation in free
ranging or confined members of the
family Cervidae (deer and elk).
(iii) Limitations. Do not use in
domestic food-producing animals. Do
not use for 30 days before or during
hunting season. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
20. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
§ 558.76
[Amended]
21. In § 558.76, in paragraph (d)(1)(x),
in the entry for ‘‘Quail’’, in the
‘‘Limitations’’ column, remove the first
sentence.
■
§ 558.105
[Removed]
22. Remove reserved § 558.105.
■ 23. In § 558.355, add paragraph
(f)(1)(xxxi) to read as follows:
■
§ 558.355
Monensin.
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*
*
*
*
*
(f) * * *
(1) * * *
(xxxi) Amount per ton. Monensin, 90
to 110 grams; plus virginiamycin, 20
grams.
(a) Indications for use. Broiler
chickens: As an aid in the prevention of
coccidiosis caused by E. necatrix, E.
tenella, E. acervulina, E. brunetti, E.
mivati, and E. maxima; and for
prevention of necrotic enteritis caused
by Clostridium perfringens susceptible
to virginiamycin.
(b) Limitations. Feed continuously as
sole ration. Do not feed to laying
chickens. See paragraph (d) of this
VerDate Sep<11>2014
17:02 Dec 12, 2014
Jkt 235001
section. As monensin provided by No.
000986; virginiamycin as provided by
No. 066104 in § 510.600(c) of this
chapter.
*
*
*
*
*
Dated: December 9, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014–29249 Filed 12–12–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
74021
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 ANADA 200–305, and all
supplements and amendments thereto,
is hereby withdrawn, effective
December 26, 2014.
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.
Dated: December 9, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014–29248 Filed 12–12–14; 8:45 am]
21 CFR Part 520
BILLING CODE 4164–01–P
[Docket No. FDA–2014–N–0002]
Oral Dosage Form New Animal Drugs;
Withdrawal of Approval of New Animal
Drug Application; Oxytetracycline
AGENCY:
Food and Drug Administration,
HHS.
Notification of withdrawal of
approval.
ACTION:
The Food and Drug
Administration (FDA) is withdrawing
approval of an abbreviated new animal
drug application (ANADA) for an
oxytetracycline soluble powder used to
make medicated drinking water for
livestock and poultry. 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 December 26, 2014.
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:
´
Vetoquinol N.-A., Inc., 2000 chemin
Georges, Lavaltrie (PQ), Canada, J5T 3S5
has requested that FDA withdraw
approval of ANADA 200–305 for
Oxytetracycline Hydrochloride Soluble
Powder because the product is no longer
manufactured or marketed. Note this
ANADA was identified as being affected
by guidance for industry (GFI) #213,
‘‘New Animal Drugs and New Animal
Drug Combination Products
Administered in or on Medicated Feed
or Drinking Water of Food-Producing
Animals: Recommendations for Drug
Sponsors for Voluntarily Aligning
Product Use Conditions with GFI #209’’,
December 2013.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
SUMMARY:
PO 00000
Frm 00007
Fmt 4700
Sfmt 4700
PENSION BENEFIT GUARANTY
CORPORATION
29 CFR Parts 4022 and 4044
Allocation of Assets in SingleEmployer Plans; Benefits Payable in
Terminated Single-Employer Plans;
Interest Assumptions for Valuing and
Paying Benefits
Pension Benefit Guaranty
Corporation.
ACTION: Final rule.
AGENCY:
This final rule amends the
Pension Benefit Guaranty Corporation’s
regulations on Benefits Payable in
Terminated Single-Employer Plans and
Allocation of Assets in Single-Employer
Plans to prescribe interest assumptions
under the benefit payments regulation
for valuation dates in January 2015 and
interest assumptions under the asset
allocation regulation for valuation dates
in the first quarter of 2015. The interest
assumptions are used for valuing and
paying benefits under terminating
single-employer plans covered by the
pension insurance system administered
by PBGC.
DATES: Effective January 1, 2015.
FOR FURTHER INFORMATION CONTACT:
Catherine B. Klion (Klion.Catherine@
PBGC.gov), Assistant General Counsel
for Regulatory Affairs, Pension Benefit
Guaranty Corporation, 1200 K Street
NW., Washington, DC 20005, 202–326–
4024. (TTY/TDD users may call the
Federal relay service toll free at 1–800–
877–8339 and ask to be connected to
202–326–4024.)
SUPPLEMENTARY INFORMATION: PBGC’s
regulations on Allocation of Assets in
Single-Employer Plans (29 CFR part
4044) and Benefits Payable in
Terminated Single-Employer Plans (29
CFR part 4022) prescribe actuarial
SUMMARY:
E:\FR\FM\15DER1.SGM
15DER1
]]>Agencies
[Federal Register Volume 79, Number 240 (Monday, December 15, 2014)]
[Unknown Section]
[Pages 74018-74021]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29249]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, and 558
[Docket No. FDA-2014-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Change of Sponsor; Withdrawal of Approval of New Animal Drug
Applications
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 approval actions for new animal drug
applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during September and October 2014. FDA is also informing the
public of the availability of summaries of the basis of approval and of
environmental review documents, where applicable. The animal drug
regulations are also being amended to reflect a change of sponsorship
of six NADAs and four ANADAs, the voluntary withdrawal of approval of
an ANADA, and a correcting amendment.
DATES: This rule is effective December 15, 2014, except for the
amendment to 21 CFR 520.1660d, which is effective December 26, 2014.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9019,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect approval actions for NADAs and ANADAs during September and
October 2014, 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.
In addition, Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601,
has transferred ownership of, and all rights and interest in, the
following approved applications to Akorn Animal Health, Inc., 1925 West
Field Ct., Suite 300, Lake Forest, IL 60045.
----------------------------------------------------------------------------------------------------------------
File No. Product name 21 CFR cite
----------------------------------------------------------------------------------------------------------------
139-236....................................... ANASED (xylazine hydrochloride) Injectable 522.2662
Solution.
140-866....................................... YOBINE (yohimbine hydrochloride) Injectable 522.2670
Solution.
140-994....................................... TOLAZINE (tolazine hydrochloride) Injectable 522.2474
Solution.
200-055....................................... VETAKET (ketamine hydrochloride) Injectable 522.1222
Solution.
200-332....................................... BUTORPHIC (butorphanol tartrate) Injectable 522.246
Solution.
----------------------------------------------------------------------------------------------------------------
Bioniche Animal Health USA, Inc., 119 Rowe Rd., Athens, GA 30601,
has transferred ownership of, and all rights and interest in, the
following approved applications to V[eacute]toquinol USA, Inc., 4250 N.
Sylvania Ave., Fort Worth, TX 76137.
----------------------------------------------------------------------------------------------------------------
File No. Product name 21 CFR cite
----------------------------------------------------------------------------------------------------------------
141-431....................................... FOLLTROPIN (follicle stimulating hormone) 522.1002
Injection.
200-266....................................... BUTEQUINE (phenylbutazone) Paste................ 520.1720c
200-432....................................... NEXHA (hyaluronate sodium) Injection............ 522.1145
----------------------------------------------------------------------------------------------------------------
[[Page 74019]]
In addition, Veterinary Service, Inc. 4100 Bangs Ave., Modesto, CA
95356, has transferred ownership of, and all rights and interest in,
NADA 065-252 for STREP-SOL (streptomycin sulfate) Oral Solution to
Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria.
Also, Elanco Animal Health, Inc., A Division of Eli Lilly & Co.,
Lilly Corporate Center, Indianapolis, IN 46285, has transferred
ownership of, and all rights and interest in, NADA 141-272 for
RECONCILE (fluoxetine hydrochloride) Chewable Tablets to Nexcyon
Pharmaceuticals, Inc., 644 West Washington Ave., Madison, WI 53703.
At this time, the regulations are being amended to reflect these
changes of sponsorship. Following these changes of sponsorship, Akorn
Animal Health, Inc., Nexcyon Pharmaceuticals, Inc., and
V[eacute]toquinol USA, Inc. will now be the sponsors of an approved
application while Bioniche Animal Health USA, Inc. and Veterinary
Service, Inc. will no longer be the sponsors of an approved
application. Accordingly, 21 CFR 510.600(c) is being amended to reflect
these changes.
FDA is also amending the regulations at 21 CFR 558.76 to remove a
limitation on the concentrations of bacitracin methylene disalicyclate
Type A medicated articles that can be used to manufacture medicated
feed for quail. In addition, FDA is removing reserved 21 CFR 558.105
for which there is no entry. These actions are being taken to improve
the accuracy of the regulations.
Also, V[eacute]toquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie
(PQ), Canada, J5T 3S5, has requested that FDA withdraw approval of
ANADA 200-305 for Oxytetracycline Hydrochloride Soluble Powder because
the product is no longer manufactured or marketed. Note this ANADA was
identified as being affected by guidance for industry (GFI) #213, ``New
Animal Drugs and New Animal Drug Combination Products Administered in
or on Medicated Feed or Drinking Water of Food-Producing Animals:
Recommendations for Drug Sponsors for Voluntarily Aligning Product Use
Conditions with GFI #209,'' December 2013.
Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of ANADA 200-305, and all supplements and amendments
thereto, is withdrawn, effective December 26, 2014. As provided in the
regulatory text of this document, the animal drug regulations are
amended to reflect this voluntary withdrawal of approval.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
Table 1--Original and Supplemental NADAs and ANADAs Approved During September and October 2014
----------------------------------------------------------------------------------------------------------------
New animal drug 21 CFR NEPA
NADA/ ANADA Sponsor product name Action sections FOIA summary review
----------------------------------------------------------------------------------------------------------------
141-244......... Zoetis Inc., DRAXXIN Supplemental 522.2630 yes............. CE1 2
333 Portage (tulathromycin approval for
St., ) Injectable treatment of
Kalamazoo, MI Solution. bovine
49007. respiratory
disease (BRD)
in suckling
calves, dairy
calves, and
veal calves.
141-430x\3\..... Phibro Animal STAFAC Original 558.355 yes............. CE1 4
Health Corp., (virginiamycin approval for
GlenPointe ) plus COBAN prevention of
Centre East, (monensin) coccidiosis
3d Floor, 300 combination and necrotic
Frank W. Burr drug Type C enteritis in
Blvd., suite medicated broiler
21, Teaneck, feeds. chickens.
NJ 07666.
200-522......... Putney, Inc., Carprofen Original 522.304 yes............. CE1 5
One Monument Sterile approval as a
Sq., suite Injectable generic copy
400, Portland, Solution. of NADA 141-
ME 04101. 199.
200-540......... Putney, Inc., Meloxicam Original 522.1367 yes............. CE1 5
One Monument (meloxicam) approval as a
Sq., suite Solution for generic copy
400, Portland, Injection. of NADA 141-
ME 04101. 219.
200-581......... Cross Vetpharm FLUNAZINE Original 520.970 yes............. CE1 5
Group Ltd., (flunixin approval as a
Broomhill Rd., meglumine) generic copy
Tallaght, Equine Paste. of NADA 137-
Dublin 24, 409.
Ireland.
----------------------------------------------------------------------------------------------------------------
\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)(5).
\3\ This application is affected by GFI #213, ``New Animal Drugs and New Animal Drug Combination Products
Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug
Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209'', December 2013.
\4\ CE granted under 21 CFR 25.33(a)(2).
\5\ CE granted under 21 CFR 25.33(a)(1).
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520 and 522
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, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), remove the
entries for ``Bioniche Animal Health USA, Inc.'' and ``Veterinary
Service, Inc.'' and
[[Page 74020]]
alphabetically add entries for ``Akorn Animal Health, Inc.'', ``Nexcyon
Pharmaceuticals, Inc.'', and ``V[eacute]toquinol USA, Inc.''; and in
the table in paragraph (c)(2), remove the entries for ``033008'' and
``064847'' and numerically add entries for ``017030'', ``050929'', and
``053599'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * *
Akorn Animal Health, Inc., 1925 West Field Ct., suite 053599
300, Lake Forest, IL 60045.............................
* * * * *
Nexcyon Pharmaceuticals, Inc., 644 West Washington Ave., 050929
Madison, WI 53719......................................
* * * * *
V[eacute]toquinol USA, Inc., 4250 N. Sylvania Ave., Fort 017030
Worth, TX 76137........................................
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
017030.............................. V[eacute]toquinol USA, Inc., 4250
N. Sylvania Ave., Fort Worth, TX
76137.
* * * * *
050929.............................. Nexcyon Pharmaceuticals, Inc., 644
West Washington Ave., Madison, WI
53719.
* * * * *
053599.............................. Akorn Animal Health, Inc., 1925
West Field Ct., suite 300, Lake
Forest, IL 60045.
* * * * *
------------------------------------------------------------------------
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. 520.970, revise paragraphs (b) and (c)(1) to read as
follows:
Sec. 520.970 Flunixin.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (c) of this section.
(1) No. 000061 for use of products described in paragraph (a).
(2) No. 061623 for use of the product described in paragraph
(a)(2).
(c) * * *
(1) Amount. 0.5 mg per pound of body weight per day for up to 5
days.
* * * * *
Sec. 520.980 [Amended]
5. In paragraph (b) of Sec. 520.980, remove ``000986'' and in its
place add ``050929''.
Sec. 520.1660d [Amended]
0
6. In Sec. 520.1660d, remove paragraph (b)(8); and in paragraphs
(d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3), (d)(1)(ii)(C)(3), and
(d)(1)(iii)(C), remove ``059320,''.
Sec. 520.1720c [Amended]
0
7. In paragraph (b)(2) of Sec. 520.1720c, remove ``064847'' and in its
place add ``017030''.
Sec. 520.2158 [Amended]
0
8. In paragraph (b) of Sec. 520.2158, remove ``033008'' and in its
place add ``016592''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
9. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.246 [Amended]
0
10. In paragraph (b)(3) of Sec. 522.246, remove ``061690'' and in its
place add ``053599''.
0
11. In Sec. 522.304, revise paragraph (b) to read as follows:
Sec. 522.304 Carprofen.
* * * * *
(b) Sponsors. See Nos. 026637, 054771, and 055529 in Sec.
510.600(c) of this chapter.
* * * * *
Sec. 522.1002 [Amended]
0
12. In paragraph (c)(2) of Sec. 522.1002, remove ``064847'' and in its
place add ``017030''.
Sec. 522.1145 [Amended]
0
13. In paragraph (e)(2)(ii) of Sec. 522.1145, remove ``064847'' and in
its place add ``017030''.
0
14. In Sec. 522.1222, revise paragraph (b) to read as follows:
Sec. 522.1222 Ketamine.
* * * * *
(b) Sponsors. See Nos. 000859, 026637, 053599, 054628, 054771, and
063286 in Sec. 510.600(c) of this chapter.
* * * * *
0
15. In Sec. 522.1367, revise paragraph (b) to read as follows:
Sec. 522.1367 Meloxicam.
* * * * *
(b) Sponsors. See Nos. 000010, 016729, 026637, and 055529 in Sec.
510.600(c) of this chapter.
* * * * *
Sec. 522.2474 [Amended]
0
16. In paragraph (b) of Sec. 522.2474, remove ``061690'' and in its
place add ``053599''.
0
17. In Sec. 522.2630, revise paragraph (d)(1) to read as follows:
Sec. 522.2630 Tulathromycin.
* * * * *
(d) * * *
(1) Cattle--(i) Amount. 2.5 mg per kilogram (/kg) body weight as a
single subcutaneous injection in the neck.
(ii) Indications for use--(A) Beef and non-lactating dairy cattle;
suckling calves, dairy calves, and veal calves: For the treatment of
bovine respiratory disease (BRD) associated with Mannheimia
haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma
bovis;
(B) Beef and non-lactating dairy cattle: For the control of
respiratory disease in cattle at high risk of developing BRD associated
with M. haemolytica, P. multocida, H. somni, and M. bovis. For the
treatment of infectious bovine keratoconjunctivitis associated with
Moraxella bovis. For the treatment of bovine foot rot (interdigital
necrobacillosis) associated with Fusobacterium necrophorum and
Porphyromonas levii.
(iii) Limitations. Cattle intended for human consumption must not
be slaughtered within 18 days from the last treatment. Do not use in
female dairy cattle 20 months of age or older. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
* * * * *
Sec. 522.2662 [Amended]
0
18. In paragraph (b)(4) of Sec. 522.2662, remove ``061690'' and in its
place add ``053599''.
0
19. Revise Sec. 522.2670 to read as follows:
Sec. 522.2670 Yohimbine.
(a) Specifications. Each milliliter (mL) of solution contains 2 or
5 milligrams (mg) of yohimbine (as hydrochloride).
[[Page 74021]]
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (c) of this section.
(1) No. 053599 for use of in 2 mg/mL solution as in paragraph
(c)(1) of this section.
(2) No. 053923 for use of in 5 mg/mL solution as in paragraph
(c)(2) of this section.
(c) Conditions of use--(1) Dogs--(i) Amount. Administer 0.05 mg per
pound (0.11 mg per kilogram) of body weight by intravenous injection.
(ii) Indications for use. To reverse the effects of xylazine in
dogs.
(iii) Limitations. Not for use in food-producing animals. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
(2) Deer and elk--(i) Amount. Administer 0.2 to 0.3 mg per kilogram
of body weight by intravenous injection.
(ii) Indications for use. A s an antagonist to xylazine sedation in
free ranging or confined members of the family Cervidae (deer and elk).
(iii) Limitations. Do not use in domestic food-producing animals.
Do not use for 30 days before or during hunting season. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
20. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.76 [Amended]
0
21. In Sec. 558.76, in paragraph (d)(1)(x), in the entry for
``Quail'', in the ``Limitations'' column, remove the first sentence.
Sec. 558.105 [Removed]
0
22. Remove reserved Sec. 558.105.
0
23. In Sec. 558.355, add paragraph (f)(1)(xxxi) to read as follows:
Sec. 558.355 Monensin.
* * * * *
(f) * * *
(1) * * *
(xxxi) Amount per ton. Monensin, 90 to 110 grams; plus
virginiamycin, 20 grams.
(a) Indications for use. Broiler chickens: As an aid in the
prevention of coccidiosis caused by E. necatrix, E. tenella, E.
acervulina, E. brunetti, E. mivati, and E. maxima; and for prevention
of necrotic enteritis caused by Clostridium perfringens susceptible to
virginiamycin.
(b) Limitations. Feed continuously as sole ration. Do not feed to
laying chickens. See paragraph (d) of this section. As monensin
provided by No. 000986; virginiamycin as provided by No. 066104 in
Sec. 510.600(c) of this chapter.
* * * * *
Dated: December 9, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-29249 Filed 12-12-14; 8:45 am]
BILLING CODE 4164-01-P
