New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications; Changes of Sponsorship, 76384-76387 [2015-31042]
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76384
Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Rules and Regulations
3 CFR, 1994 Comp., p. 950; E.O. 13020, 61
FR 54079, 3 CFR, 1996 Comp., p. 219; E.O.
13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
228; E.O. 13222, 66 FR 44025, 3 CFR, 2001
Comp., p. 783; E.O. 13637, 78 FR 16129, 3
CFR, 2014 Comp., p. 223; Notice of August
7, 2015, 80 FR 48233 (August 11, 2015);
Notice of November 12, 2015, 80 FR 70667
(November 13, 2015).
15 CFR Part 734
Administrative practice and
procedure, Exports, Inventions and
patents, Research, Science and
technology.
15 CFR Part 736
Exports.
15 CFR Part 742
PART 736—[AMENDED]
Exports, Terrorism.
3. The authority citation for 15 CFR
part 736 is revised to read as follows:
■
15 CFR Part 744
Exports, Reporting and recordkeeping
requirements, Terrorism.
PART 745—[AMENDED]
6. The authority citation for 15 CFR
part 745 is revised to read as follows:
■
Authority: 50 U.S.C. 1701 et seq.; E.O.
12938, 59 FR 59099, 3 CFR, 1994 Comp., p.
950; Notice of November 12, 2015, 80 FR
70667 (November 13, 2015).
Dated: November 30, 2015.
Kevin J. Wolf,
Assistant Secretary for Export
Administration.
[FR Doc. 2015–30753 Filed 12–8–15; 8:45 am]
Authority: 50 U.S.C. app. 2401 et seq.; 50
U.S.C. 1701 et seq.; 22 U.S.C. 2151 note; E.O.
12938, 59 FR 59099, 3 CFR, 1994 Comp., p.
950; E.O. 13020, 61 FR 54079, 3 CFR, 1996
Comp., p. 219; E.O. 13026, 61 FR 58767, 3
CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR
44025, 3 CFR, 2001 Comp., p. 783; E.O.
13338, 69 FR 26751, 3 CFR, 2004 Comp., p.
168; Notice of May 6, 2015, 80 FR 26815
(May 8, 2015); Notice of August 7, 2015, 80
FR 48233 (August 11, 2015); Notice of
November 12, 2015, 80 FR 70667 (November
13, 2015).
BILLING CODE 3510–33–P
■
1. The authority citation for 15 CFR
part 730 is revised to read as follows:
PART 742—[AMENDED]
Authority: 50 U.S.C. app. 2401 et seq.; 50
U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C.
7430(e); 22 U.S.C. 287c; 22 U.S.C. 2151 note;
22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 30
U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42
U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C. 1824a;
50 U.S.C. app. 5; 22 U.S.C. 7201 et seq.; 22
U.S.C. 7210; E.O. 11912, 41 FR 15825, 3 CFR,
1976 Comp., p. 114; E.O. 12002, 42 FR 35623,
3 CFR, 1977 Comp., p. 133; E.O. 12058, 43
FR 20947, 3 CFR, 1978 Comp., p. 179; E.O.
12214, 45 FR 29783, 3 CFR, 1980 Comp., p.
256; E.O. 12851, 58 FR 33181, 3 CFR, 1993
Comp., p. 608; E.O. 12854, 58 FR 36587, 3
CFR, 1993 Comp., p. 179; E.O. 12918, 59 FR
28205, 3 CFR, 1994 Comp., p. 899; E.O.
12938, 59 FR 59099, 3 CFR, 1994 Comp., p.
950; E.O. 12947, 60 FR 5079, 3 CFR, 1995
Comp., p. 356; E.O. 12981, 60 FR 62981, 3
CFR, 1995 Comp., p. 419; E.O. 13020, 61 FR
54079, 3 CFR, 1996 Comp., p. 219; E.O.
13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
228; E.O. 13099, 63 FR 45167, 3 CFR, 1998
Comp., p. 208; E.O. 13222, 66 FR 44025, 3
CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR
49079, 3 CFR, 2001 Comp., p. 786; E.O.
13338, 69 FR 26751, 3 CFR, 2004 Comp., p
168; E.O. 13637, 78 FR 16129, 3 CFR, 2014
Comp., p. 223; Notice of January 21, 2015, 80
FR 3461 (January 22, 2015); Notice of May 6,
2015, 80 FR 26815 (May 8, 2015); Notice of
August 7, 2015, 80 FR 48233 (August 11,
2015); Notice of September 18, 2015, 80 FR
57281 (September 22, 2015); Notice of
November 12, 2015, 80 FR 70667 (November
13, 2015).
■
New Animal Drugs; Approval of New
Animal Drug Applications;
Withdrawals of Approval of New
Animal Drug Applications; Changes of
Sponsorship
15 CFR Part 745
Administrative practice and
procedure, Chemicals, Exports, Foreign
trade, Reporting and recordkeeping
requirements.
Accordingly, parts 730, 734, 736, 742,
744, and 745 of the EAR (15 CFR parts
730–774) are amended as follows:
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PART 730—[AMENDED]
PART 734—[AMENDED]
2. The authority citation for 15 CFR
part 734 is revised to read as follows:
■
Authority: 50 U.S.C. app. 2401 et seq.; 50
U.S.C. 1701 et seq.; E.O. 12938, 59 FR 59099,
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15:17 Dec 08, 2015
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4. The authority citation for 15 CFR
part 742 is revised to read as follows:
Authority: 50 U.S.C. app. 2401 et seq.; 50
U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.;
42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22
U.S.C. 7210; Sec. 1503, Pub. L. 108–11, 117
Stat. 559; E.O. 12058, 43 FR 20947, 3 CFR,
1978 Comp., p. 179; E.O. 12851, 58 FR 33181,
3 CFR, 1993 Comp., p. 608; E.O. 12938, 59
FR 59099, 3 CFR, 1994 Comp., p. 950; E.O.
13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
228; E.O. 13222, 66 FR 44025, 3 CFR, 2001
Comp., p. 783; Presidential Determination
2003–23, 68 FR 26459, 3 CFR, 2004 Comp.,
p. 320; Notice of August 7, 2015, 80 FR 48233
(August 11, 2015); Notice of November 12,
2015, 80 FR 70667 (November 13, 2015).
PART 744—[AMENDED]
5. The authority citation for 15 CFR
part 744 is revised to read as follows:
■
Authority: 50 U.S.C. app. 2401 et seq.; 50
U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.;
42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22
U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR,
1978 Comp., p. 179; E.O. 12851, 58 FR 33181,
3 CFR, 1993 Comp., p. 608; E.O. 12938, 59
FR 59099, 3 CFR, 1994 Comp., p. 950; E.O.
12947, 60 FR 5079, 3 CFR, 1995 Comp., p.
356; E.O. 13026, 61 FR 58767, 3 CFR, 1996
Comp., p. 228; E.O. 13099, 63 FR 45167, 3
CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR
44025, 3 CFR, 2001 Comp., p. 783; E.O.
13224, 66 FR 49079, 3 CFR, 2001 Comp., p.
786; Notice of January 21, 2015, 80 FR 3461
(January 22, 2015); Notice of August 7, 2015,
80 FR 48233 (August 11, 2015); Notice of
September 18, 2015, 80 FR 57281 (September
22, 2015); Notice of November 12, 2015, 80
FR 70667 (November 13, 2015).
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and
558
[Docket No. FDA–2015–N–0002]
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
application-related actions for new
animal drug applications (NADAs) and
abbreviated new animal drug
applications (ANADAs) during
September and October 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 and the
voluntary withdrawals of approval of
applications that occurred in September
and October 2015.
DATES: This rule is effective December 9,
2015, except for the amendments to 21
CFR 520.446, 520.2043, 558.625, and
558.630, which are effective December
21, 2015.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Rules and Regulations
I. Approval Actions
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs and ANADAs during
September and October 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 Center for Veterinary
76385
Medicine 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 SEPTEMBER AND OCTOBER 2015
21 CFR
section
FOIA
summary
NEPA
review
File No.
Sponsor
Product name
Action
141–440 .......
Piedmont Animal
Health, 204 Muirs
Chapel Rd., suite 200,
Greensboro, NC
27410.
Intervet, Inc., 2 Giralda
Farms, Madison, NJ
07940.
CLARO (florfenicol,
terbinafine,
mometasone furoate)
Otic Solution.
Original approval for the treatment of otitis externa in
dogs.
524.957
yes .............
CE.1 2
SAFE–GUARD AquaSol
(fenbendazole oral
suspension) Suspension Concentrate.
520.905a
yes .............
EA/
FONSI.3
141–442 .......
Zoetis Inc., 333 Portage
St., Kalamazoo, MI
49007.
522.690
yes .............
CE.1 4
108–901 .......
Zoetis Inc. 333 Portage
St., Kalamazoo, MI
49007.
LUTALYSE HighCon
(dinoprost
tromethamine injection) Injection.
LUTALYSE (dinoprost
tromethamine injection) Injection.
Original approval for the treatment and control of certain
nematode worms in broiler
chickens, replacement
chickens intended to become breeding chickens,
and breeding chickens.
Supplemental approval of subcutaneous route of administration.
Supplemental approval of revised indications for uses in
cattle.
522.690
no ..............
CE.1 4
141–449 .......
1 The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or
an environmental impact statement because it is of a type that does not have a significant effect on the human environment.
2 CE granted under 21 CFR 25.33(d)(1).
3 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).
4 CE granted under 21 CFR 25.33(a)(1).
II. Changes of Sponsorship
During September and October 2015,
ownership of, and all rights and interest
in, the following approved applications
have been transferred as follows:
File No.
Previous sponsor
Product name
New sponsor
141–440 .........
Piedmont Animal Health, 204
Muirs Chapel Rd., suite 200,
Greensboro, NC 27410.
Orkeo USA, Inc., 77 Water St.,
New York, NY 10005.
CLARO (florfenicol, terbinafine,
mometasone furoate) Otic Solution.
LONCOR
300
(florfenicol)
Injectable Solution.
Bayer HealthCare LLC, Animal
Health Division, P.O. Box 390,
Shawnee Mission, KS 66201.
Bayer HealthCare LLC, Animal
Health Division, P.O. Box 390,
Shawnee Mission, KS 66201.
200–582 .........
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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. Following the
change of sponsorship of ANADA 200–
582, Orkeo USA, Inc., is no longer the
sponsor of an approved application.
III. Withdrawals of Approval
In addition, during September and
October 2015, the following three
Sponsor
Product name
140–680 1 .................
Pharmgate LLC, 1015 Ashes Dr., suite 102, Wilmington, NC 28405.
TYLAN (tylosin phosphate) Premix .........................
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524.957
522.955
sponsors have requested that FDA
withdraw approval of the NADAs and
ANADAs listed in the following table
because the products are no longer
manufactured or marketed:
File No.
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21 CFR
section
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21 CFR
section
558.625
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Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Rules and Regulations
21 CFR
section
File No.
Sponsor
Product name
140–681 1 .................
Pharmgate LLC, 1015 Ashes Dr., suite 102, Wilmington, NC 28405.
Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514.
Bayer HealthCare LLC, Animal Health Division,
P.O. Box 390, Shawnee Mission, KS 66201.
TYLAN SULFA G (tylosin phosphate and
sulfamethazine) Premix.
EVICT 300 (pyrantel pamoate) Suspension ...........
520.2043
CLINDAROBE (clindamycin) Capsules ..................
520.446
200–028 ...................
200–383 ...................
558.630
1 These NADAs were identified as being affected by guidance for industry #213, ‘‘New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily
Aligning Product Use Conditions with GFI #209,’’ December 2013.
Elsewhere in this issue of the Federal
Register, FDA gave notice that approval
of NADA 140–680, NADA 140–681,
ANADA 200–028, and ANADA 200–
383, and all supplements and
amendments thereto, is withdrawn,
effective December 21, 2015. As
provided in the regulatory text of this
document, the animal drug regulations
are amended to reflect these voluntary
withdrawals of approval.
IV. Technical Amendments
FDA has noticed that a previous
sponsor of ANADA 200–383, Teva
Canada Ltd., was no longer the sponsor
of an approved application following a
prior change of sponsorship. At this
time, FDA is amending the regulation to
remove the firm from the listings of
sponsors of approved applications in 21
CFR 510.600. This action is being taken
to improve the accuracy of the
regulations.
FDA is also revising the special
considerations for medicated feeds
containing veterinary feed directive
drugs to align with 21 CFR 558.6(a)(6),
which was recently amended (80 FR
31708, June 3, 2015). This action is
being taken to improve the consistency
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.
CFR parts 510, 520, 522, 524, and 558
are amended as follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
§ 510.600
[Amended]
2. In § 510.600:
a. In the table in paragraph (c)(1),
remove the entries for ‘‘Orkeo USA,
Inc.’’ and ‘‘Teva Canada Ltd.’’; and
■ b. In the table in paragraph (c)(2),
remove the entries for ‘‘043806’’ and
‘‘086050’’.
■
■
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 520.446
[Amended]
§ 520.905a
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
(a) Specifications. Each milliliter of
suspension contains 100 milligrams
(mg) fenbendazole for use as in
paragraphs (e)(1), (2), (3), and (4) of this
section; or 200 mg fenbendazole for use
as in paragraph (e)(5) of this section.
*
*
*
*
*
(e) * * *
(4) * * *
(i) Amount. Administer orally 5 mg/
kg of body weight (2.3 mg/lb).
Retreatment may be needed after 4 to 6
weeks.
*
*
*
*
*
(5) Chickens—(i) Amount. Administer
orally via drinking water at a daily dose
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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
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Fenbendazole suspension.
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§ 520.2043
[Amended]
6. Effective December 21, 2015, in
§ 520.2043, in paragraph (b)(2), remove
‘‘Nos. 054771, 055246, 058829, and
059130’’ and in its place add ‘‘Nos.
000859, 054771, and 058829’’.
■
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
7. The authority citation for 21 CFR
part 522 continues to read as follows:
■
4. Effective December 21, 2015, in
§ 520.446, in paragraph (b)(1), remove
‘‘Nos. 000859 and 054771’’ and in its
place add ‘‘No. 054771’’.
■ 5. In § 520.905a:
■ a. Revise paragraphs (a) and (e)(4)(i);
■ b. In paragraph (e)(4)(iii), remove the
first sentence; and
■ c. Add paragraph (e)(5).
The revisions and addition read as
follows:
■
List of Subjects
21 CFR Parts 520, 522, and 524
Animal drugs.
of 1 mg/kg body weight (0.454 mg/lb)
for 5 consecutive days.
(ii) Indications for use. For the
treatment and control of adult Ascaridia
galli in broiler chickens and
replacement chickens intended to
become breeding chickens, and for the
treatment and control of adult A. galli
and Heterakis gallinarum in breeding
chickens.
(iii) Limitations. Not for use in laying
hens and replacement chickens
intended to become laying hens.
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Authority: 21 U.S.C. 360b.
8. In § 522.690, revise paragraphs
(b)(2) and (d)(1)(i) and add paragraph
(b)(3) to read as follows:
■
§ 522.690
Dinoprost.
*
*
*
*
*
(b) * * *
(2) No. 054771 for use of the 5 mg/mL
product as in paragraphs (d)(1), (2), and
(3) of this section.
(3) No. 000859 for use of the 5 mg/mL
product as in paragraphs (d)(2), (3), and
(4) of this section.
*
*
*
*
*
(d) * * *
(1) * * *
(i) Amount. 25 mg as a single
intramuscular or subcutaneous
injection.
*
*
*
*
*
§ 522.955
[Amended]
9. In § 522.955(b)(2), remove
‘‘086050’’ and in its place add
‘‘000859’’.
■
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Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Rules and Regulations
directive (VFD) drug to use by or on the
order of a licensed veterinarian. See
§ 558.6 for additional requirements.
*
*
*
*
*
■ 14. In § 558.261, revise paragraphs
(c)(1) and (2) introductory text to read
as follows:
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
10. The authority citation for 21 CFR
part 524 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
11. Add § 524.957 to read as follows:
§ 558.261
§ 524.957 Florfenicol, terbinafine, and
mometasone otic solution.
Florfenicol.
*
(a) Specifications. Each single-dose,
prefilled dropperette contains 1
milliliter (mL) of a solution containing
15 milligrams (mg) florfenicol, 13.3 mg
terbinafine, and 2 mg mometasone
furoate.
(b) Sponsor. See No. 000859 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer one dropperette (1
mL) per affected ear(s).
(2) Indications for use. For the
treatment of otitis externa in dogs
associated with susceptible strains of
yeast (Malassezia pachydermatis) and
bacteria (Staphylococcus
pseudintermedius).
(3) Limitations. 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
12. The authority citation for 21 CFR
part 558 continues to read as follows:
ACTION:
§ 558.618
Tilmicosin.
*
*
*
*
*
(c) * * *
(1) Federal law restricts medicated
feed containing this veterinary feed
directive (VFD) drug to use by or on the
order of a licensed veterinarian. See
§ 558.6 for additional requirements.
*
*
*
*
*
■
[Amended]
13. In § 558.68, revise paragraph (c)(1)
to read as follows:
16. Effective December 21, 2015, in
§ 558.625, remove paragraph (b)(5) and
redesignate paragraph (b)(6) as
paragraph (b)(5).
§ 558.68
§ 558.630
21 CFR Parts 520 and 558
[Docket No. FDA–2015–N–0002]
New Animal Drugs; Withdrawal of
Approval of New Animal Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of two new animal drug
applications (NADAs) and two
abbreviated new animal drug
applications (ANADAs). This action is
being taken at the sponsors’ requests
because these products are no longer
manufactured or marketed.
DATES: Withdrawal of approval is
effective December 21, 2015.
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5761,
sujaya.dessai@fda.hhs.gov.
SUMMARY:
The
following three sponsors have requested
that FDA withdraw approval of the
NADAs and ANADAs listed in the
following table because the products are
no longer manufactured or marketed:
SUPPLEMENTARY INFORMATION:
[Amended]
17. Effective December 21, 2015, in
§ 558.630, in paragraph (b)(2), remove
‘‘Nos. 054771 and 069254’’ and in its
place add ‘‘No. 054771’’.
■
*
*
*
*
(c) * * *
(1) Federal law restricts medicated
feed containing this veterinary feed
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
15. In § 558.618, revise paragraph
(c)(1) to read as follows:
■
Authority: (P≤21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
*
BILLING CODE 4164–01–P
Food and Drug Administration
§ 558.625
Avilamycin.
[FR Doc. 2015–31042 Filed 12–8–15; 8:45 am]
*
*
*
*
(c) * * *
(1) Federal law restricts medicated
feed containing this veterinary feed
directive (VFD) drug to use by or on the
order of a licensed veterinarian. See
§ 558.6 for additional requirements.
(2) The expiration date of VFDs for
florfenicol medicated feeds:
*
*
*
*
*
■
■
Dated: December 4, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
21 CFR
section
File No.
Sponsor
Product name
140–680 1 .......................
Pharmgate LLC, 1015 Ashes Dr., suite 102, Wilmington, NC 28405.
Pharmgate LLC, 1015 Ashes Dr., suite 102, Wilmington, NC 28405.
Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514.
Bayer HealthCare LLC, Animal Health Division,
P.O. Box 390, Shawnee Mission, KS 66201.
TYLAN (tylosin phosphate) Premix ......................
558.625
TYLAN SULFA G (tylosin phosphate and
sulfamethazine) Premix.
EVICT 300 (pyrantel pamoate) Suspension ........
558.630
520.2043
CLINDAROBE (clindamycin) Capsules ................
520.446
140–681 1 .......................
200–028 .........................
200–383 .........................
wgreen on DSK2VPTVN1PROD with RULES
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.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
Veterinary Medicine, and in accordance
with 21 CFR 514.116 Notice of
VerDate Sep<11>2014
15:17 Dec 08, 2015
Jkt 238001
withdrawal of approval of application,
notice is given that approval of NADA
140–680, NADA 140–681, ANADA 200–
028, and ANADA 200–383, and all
supplements and amendments thereto,
PO 00000
Frm 00033
Fmt 4700
Sfmt 4700
is hereby withdrawn, effective
December 21, 2015.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
E:\FR\FM\09DER1.SGM
09DER1
]]>Agencies
[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Rules and Regulations]
[Pages 76384-76387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31042]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and 558
[Docket No. FDA-2015-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawals of Approval of New Animal Drug Applications; Changes of
Sponsorship
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect application-related actions for new animal
drug applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during September and October 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 and the voluntary withdrawals of approval of applications
that occurred in September and October 2015.
DATES: This rule is effective December 9, 2015, except for the
amendments to 21 CFR 520.446, 520.2043, 558.625, and 558.630, which are
effective December 21, 2015.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-402-5689,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
[[Page 76385]]
I. Approval Actions
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during September and October 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 Center for Veterinary Medicine 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 September and October 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR
File No. Sponsor Product name Action section FOIA summary NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-440......................... Piedmont Animal CLARO (florfenicol, Original approval for 524.957 yes............... CE.1 2
Health, 204 Muirs terbinafine, the treatment of
Chapel Rd., suite mometasone furoate) otitis externa in dogs.
200, Greensboro, NC Otic Solution.
27410.
141-449......................... Intervet, Inc., 2 SAFE-GUARD AquaSol Original approval for 520.905a yes............... EA/
Giralda Farms, (fenbendazole oral the treatment and FONSI.\3\
Madison, NJ 07940. suspension) control of certain
Suspension nematode worms in
Concentrate. broiler chickens,
replacement chickens
intended to become
breeding chickens, and
breeding chickens.
141-442......................... Zoetis Inc., 333 LUTALYSE HighCon Supplemental approval 522.690 yes............... CE.1 4
Portage St., (dinoprost of subcutaneous route
Kalamazoo, MI 49007. tromethamine of administration.
injection)
Injection.
108-901......................... Zoetis Inc. 333 LUTALYSE (dinoprost Supplemental approval 522.690 no................ CE.1 4
Portage St., tromethamine of revised indications
Kalamazoo, MI 49007. injection) for uses in cattle.
Injection.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an
environmental impact statement because it is of a type that does not have a significant effect on the human environment.
\2\ CE granted under 21 CFR 25.33(d)(1).
\3\ 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).
\4\ CE granted under 21 CFR 25.33(a)(1).
II. Changes of Sponsorship
During September and October 2015, ownership of, and all rights and
interest in, the following approved applications have been transferred
as follows:
----------------------------------------------------------------------------------------------------------------
21 CFR
File No. Previous sponsor Product name New sponsor section
----------------------------------------------------------------------------------------------------------------
141-440...................... Piedmont Animal CLARO (florfenicol, Bayer HealthCare 524.957
Health, 204 Muirs terbinafine, LLC, Animal Health
Chapel Rd., suite mometasone furoate) Division, P.O. Box
200, Greensboro, NC Otic Solution. 390, Shawnee
27410. Mission, KS 66201.
200-582...................... Orkeo USA, Inc., 77 LONCOR 300 Bayer HealthCare 522.955
Water St., New York, (florfenicol) LLC, Animal Health
NY 10005. Injectable Solution. Division, P.O. Box
390, Shawnee
Mission, KS 66201.
----------------------------------------------------------------------------------------------------------------
As provided in the regulatory text of this document, the animal drug
regulations are amended to reflect these changes of sponsorship.
Following the change of sponsorship of ANADA 200-582, Orkeo USA, Inc.,
is no longer the sponsor of an approved application.
III. Withdrawals of Approval
In addition, during September and October 2015, the following three
sponsors have requested that FDA withdraw approval of the NADAs and
ANADAs listed in the following table because the products are no longer
manufactured or marketed:
----------------------------------------------------------------------------------------------------------------
21 CFR
File No. Sponsor Product name section
----------------------------------------------------------------------------------------------------------------
140-680 \1\......................... Pharmgate LLC, 1015 Ashes TYLAN (tylosin phosphate) 558.625
Dr., suite 102, Wilmington, Premix.
NC 28405.
[[Page 76386]]
140-681 \1\......................... Pharmgate LLC, 1015 Ashes TYLAN SULFA G (tylosin 558.630
Dr., suite 102, Wilmington, phosphate and
NC 28405. sulfamethazine) Premix.
200-028............................. Pegasus Laboratories, Inc., EVICT 300 (pyrantel pamoate) 520.2043
8809 Ely Rd., Pensacola, FL Suspension.
32514.
200-383............................. Bayer HealthCare LLC, Animal CLINDAROBE (clindamycin) 520.446
Health Division, P.O. Box Capsules.
390, Shawnee Mission, KS
66201.
----------------------------------------------------------------------------------------------------------------
\1\ These NADAs were identified as being affected by guidance for industry #213, ``New Animal Drugs and New
Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing
Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,''
December 2013.
Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADA 140-680, NADA 140-681, ANADA 200-028, and ANADA
200-383, and all supplements and amendments thereto, is withdrawn,
effective December 21, 2015. As provided in the regulatory text of this
document, the animal drug regulations are amended to reflect these
voluntary withdrawals of approval.
IV. Technical Amendments
FDA has noticed that a previous sponsor of ANADA 200-383, Teva
Canada Ltd., was no longer the sponsor of an approved application
following a prior change of sponsorship. At this time, FDA is amending
the regulation to remove the firm from the listings of sponsors of
approved applications in 21 CFR 510.600. This action is being taken to
improve the accuracy of the regulations.
FDA is also revising the special considerations for medicated feeds
containing veterinary feed directive drugs to align with 21 CFR
558.6(a)(6), which was recently amended (80 FR 31708, June 3, 2015).
This action is being taken to improve the consistency of the
regulations.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability''.
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, and 524
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
520, 522, 524, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 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:
0
a. In the table in paragraph (c)(1), remove the entries for ``Orkeo
USA, Inc.'' and ``Teva Canada Ltd.''; and
0
b. In the table in paragraph (c)(2), remove the entries for ``043806''
and ``086050''.
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. 520.446 [Amended]
0
4. Effective December 21, 2015, in Sec. 520.446, in paragraph (b)(1),
remove ``Nos. 000859 and 054771'' and in its place add ``No. 054771''.
0
5. In Sec. 520.905a:
0
a. Revise paragraphs (a) and (e)(4)(i);
0
b. In paragraph (e)(4)(iii), remove the first sentence; and
0
c. Add paragraph (e)(5).
The revisions and addition read as follows:
Sec. 520.905a Fenbendazole suspension.
(a) Specifications. Each milliliter of suspension contains 100
milligrams (mg) fenbendazole for use as in paragraphs (e)(1), (2), (3),
and (4) of this section; or 200 mg fenbendazole for use as in paragraph
(e)(5) of this section.
* * * * *
(e) * * *
(4) * * *
(i) Amount. Administer orally 5 mg/kg of body weight (2.3 mg/lb).
Retreatment may be needed after 4 to 6 weeks.
* * * * *
(5) Chickens--(i) Amount. Administer orally via drinking water at a
daily dose of 1 mg/kg body weight (0.454 mg/lb) for 5 consecutive days.
(ii) Indications for use. For the treatment and control of adult
Ascaridia galli in broiler chickens and replacement chickens intended
to become breeding chickens, and for the treatment and control of adult
A. galli and Heterakis gallinarum in breeding chickens.
(iii) Limitations. Not for use in laying hens and replacement
chickens intended to become laying hens.
Sec. 520.2043 [Amended]
0
6. Effective December 21, 2015, in Sec. 520.2043, in paragraph (b)(2),
remove ``Nos. 054771, 055246, 058829, and 059130'' and in its place add
``Nos. 000859, 054771, and 058829''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
7. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
8. In Sec. 522.690, revise paragraphs (b)(2) and (d)(1)(i) and add
paragraph (b)(3) to read as follows:
Sec. 522.690 Dinoprost.
* * * * *
(b) * * *
(2) No. 054771 for use of the 5 mg/mL product as in paragraphs
(d)(1), (2), and (3) of this section.
(3) No. 000859 for use of the 5 mg/mL product as in paragraphs
(d)(2), (3), and (4) of this section.
* * * * *
(d) * * *
(1) * * *
(i) Amount. 25 mg as a single intramuscular or subcutaneous
injection.
* * * * *
Sec. 522.955 [Amended]
0
9. In Sec. 522.955(b)(2), remove ``086050'' and in its place add
``000859''.
[[Page 76387]]
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
10. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
11. Add Sec. 524.957 to read as follows:
Sec. 524.957 Florfenicol, terbinafine, and mometasone otic solution.
(a) Specifications. Each single-dose, prefilled dropperette
contains 1 milliliter (mL) of a solution containing 15 milligrams (mg)
florfenicol, 13.3 mg terbinafine, and 2 mg mometasone furoate.
(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer one
dropperette (1 mL) per affected ear(s).
(2) Indications for use. For the treatment of otitis externa in
dogs associated with susceptible strains of yeast (Malassezia
pachydermatis) and bacteria (Staphylococcus pseudintermedius).
(3) Limitations. 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
12. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: (P>21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
13. In Sec. 558.68, revise paragraph (c)(1) to read as follows:
Sec. 558.68 Avilamycin.
* * * * *
(c) * * *
(1) Federal law restricts medicated feed containing this veterinary
feed directive (VFD) drug to use by or on the order of a licensed
veterinarian. See Sec. 558.6 for additional requirements.
* * * * *
0
14. In Sec. 558.261, revise paragraphs (c)(1) and (2) introductory
text to read as follows:
Sec. 558.261 Florfenicol.
* * * * *
(c) * * *
(1) Federal law restricts medicated feed containing this veterinary
feed directive (VFD) drug to use by or on the order of a licensed
veterinarian. See Sec. 558.6 for additional requirements.
(2) The expiration date of VFDs for florfenicol medicated feeds:
* * * * *
0
15. In Sec. 558.618, revise paragraph (c)(1) to read as follows:
Sec. 558.618 Tilmicosin.
* * * * *
(c) * * *
(1) Federal law restricts medicated feed containing this veterinary
feed directive (VFD) drug to use by or on the order of a licensed
veterinarian. See Sec. 558.6 for additional requirements.
* * * * *
Sec. 558.625 [Amended]
0
16. Effective December 21, 2015, in Sec. 558.625, remove paragraph
(b)(5) and redesignate paragraph (b)(6) as paragraph (b)(5).
Sec. 558.630 [Amended]
0
17. Effective December 21, 2015, in Sec. 558.630, in paragraph (b)(2),
remove ``Nos. 054771 and 069254'' and in its place add ``No. 054771''.
Dated: December 4, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-31042 Filed 12-8-15; 8:45 am]
BILLING CODE 4164-01-P
