New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship, 21688-21694 [2017-09364]
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21688
Federal Register / Vol. 82, No. 89 / Wednesday, May 10, 2017 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and
558
[Docket No. FDA–2017–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Withdrawal
of Approval of New Animal Drug
Applications; Changes of Sponsorship
AGENCY:
Food and Drug Administration,
HHS.
Final rule; correcting
amendments.
ACTION:
The Food and Drug
Administration (FDA or we) is
amending the animal drug regulations to
reflect application-related actions for
new animal drug applications (NADAs)
and abbreviated new animal drug
applications (ANADAs) during January
and February 2017. FDA is also
informing the public of the availability
SUMMARY:
of summaries of the basis of approval
and of environmental review
documents, where applicable. The
animal drug regulations are also being
amended to reflect several changes of
sponsorship of applications and to make
correcting amendments to improve the
accuracy of the regulations.
DATES: This rule is effective May 10,
2017, except for amendatory instruction
3 to 21 CFR 510.600, and amendatory
instruction 10 to 21 CFR 522.1002,
which are effective May 22, 2017.
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 an ANADA during
January and February 2017, as listed in
table 1. In addition, FDA is informing
the public of the availability, where
applicable, of documentation of
environmental review required under
the National Environmental Policy Act
(NEPA) and, for actions requiring
review of safety or effectiveness data,
summaries of the basis of approval (FOI
Summaries) under the Freedom of
Information Act (FOIA). These public
documents may be seen in the Division
of Dockets Management (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852, between 9 a.m. and 4 p.m.,
Monday through Friday. Persons with
access to the Internet may obtain these
documents at the CVM FOIA Electronic
Reading Room: https://www.fda.gov/
AboutFDA/CentersOffices/
OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm. Marketing exclusivity and
patent information may be accessed in
FDA’s publication, Approved Animal
Drug Products Online (Green
Book) at: https://www.fda.gov/
AnimalVeterinary/Products/
ApprovedAnimalDrugProducts/
default.htm.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY AND FEBRUARY 2017
Approval date
File No.
Public
documents
Sponsor
Product name
Species
Effect of the action
Phibro Animal Health Corp.,
GlenPointe Centre East,
3d Floor, 300 Frank W.
Burr Blvd., Suite 21, Teaneck, NJ 07666.
Phibro Animal Health Corp.,
GlenPointe Centre East,
3d Floor, 300 Frank W.
Burr Blvd., Suite 21, Teaneck, NJ 07666.
Phibro Animal Health Corp.,
GlenPointe Centre East,
3d Floor, 300 Frank W.
Burr Blvd., Suite 21, Teaneck, NJ 07666.
Huvepharma AD, 5th Floor,
3A Nikolay Haytov
Str.,1113 Sophia, Bulgaria.
STAFAC (virginiamycin)
plus BIO–COX
(salinomycin) combination
drug Type C medicated
feeds.
STAFAC (virginiamycin)
plus AMPROL
(amprolium) combination
drug Type C medicated
feeds.
STAFAC (virginiamycin)
plus AVATEC (lasalocid)
combination drug Type C
medicated feeds.
Chickens .........
Original approval for prevention of necrotic enteritis and coccidiosis in
broiler chickens.
FOI Summary.
Chickens .........
Original approval for prevention of necrotic enteritis and coccidiosis in
broiler chickens.
FOI Summary.
Chickens .........
Original approval for prevention of necrotic enteritis and coccidiosis in
broiler chickens.
FOI Summary.
STAFAC (virginiamycin)
plus CLINACOX
(diclazuril) combination
drug Type C medicated
feeds.
REVALOR–XR (trenbolone
acetate and estradiol) Extended-Release Implant.
Chickens .........
Original approval for prevention of necrotic enteritis and coccidiosis in
broiler chickens.
FOI Summary.
Cattle ...............
FOI Summary;
EA/FONSI.1
DIROBAN (melarsomine
dihydrochloride) Powder
for Injection.
Dogs ................
Original approval for increased rate of weight
gain and improved feed
efficiency during 70 to
200 days after implantation in beef steers and
heifers fed in confinement
for slaughter.
Original approval as a generic copy of NADA 141–
042.
January 13, 2017 .......
141–468
January 13, 2017 .......
141–469
January 13, 2017 .......
141–470
January 13, 2017 .......
141–472
February 13, 2017 ......
141–445
Intervet, Inc., 2 Giralda
Farms,Madison, NJ
07940.
February 17, 2017 ......
200–609
Anzac Animal Health, LLC,
218 Millwell Dr., Suite B,
Maryland Heights, MO
63043.
FOI Summary.
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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).
Following the approval of ANADA
200–609, Anzac Animal Health, LLC
will now be included in the lists of
sponsors of approved applications in
§ 510.600(c) (21 CFR 510.600(c)).
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II. Changes of Sponsorship
Boehringer Ingelheim Vetmedica, Inc.,
2621 North Belt Highway, St. Joseph,
MO 64506–2002 has informed FDA that
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it has transferred ownership of, and all
rights and interest in, the following
applications to Bayer HealthCare LLC,
Animal Health Division, P.O. Box 390,
Shawnee Mission, KS 66201:
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Federal Register / Vol. 82, No. 89 / Wednesday, May 10, 2017 / Rules and Regulations
File No.
Product name
141–099 ............
141–220 ............
141–247 ............
CYDECTIN (moxidectin) Pour-On for Beef and Dairy Cattle ..........................................................................
CYDECTIN (moxidectin) Injectable Solution for Beef and Nonlactating Dairy Cattle .....................................
CYDECTIN (moxidectin) Oral Drench for Sheep ............................................................................................
Ceva Sante Animale, 10 Avenue de la
`
Ballastiere, 33500 Libourne, France has
informed FDA that it has transferred
21 CFR section
ownership of, and all rights and interest
in, the following applications to Cross
Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland:
File No.
Product name
141–420 ............
200–481 ............
TILDREN (tiludronate disodium) Powder for Infusion .....................................................................................
ALTRESYN (altrenogest) Solution 0.22% .......................................................................................................
Cross Vetpharm Group Ltd.,
Broomhill Rd., Tallaght, Dublin 24,
Ireland has informed FDA that it has
21 CFR section
transferred ownership of, and all rights
and interest in, the following
application to Ceva Sante Animale, 10
522.2473
520.48
`
Avenue de la Ballastiere, 33500
Libourne, France:
File No.
Product name
200–587 ............
FERROFORTE (gleptoferron) Solution, 200 mg/mL .......................................................................................
Nexcyon Pharmaceuticals, Inc., P.O.
Box 259158, Madison, WI 53725 has
informed FDA that it has transferred
21 CFR section
ownership of, and all rights and interest
in, the following applications to Pegasus
Product name
141–272 ............
RECONCILE (fluoxetine hydrochloride) Chewable Tablets ............................................................................
Accordingly, the animal drug
regulations are being amended to reflect
these changes of sponsorship. Following
this withdrawal of approval, Nexcyon
Pharmaceuticals, Inc. is no longer the
sponsor of an approved application.
21 CFR section
Accordingly, it will be removed from
the list of sponsors of approved
applications in § 510.600(c).
III. Withdrawals of Approval
In addition, during January and
February 2017, the following sponsor
Sponsor
Product name
009–505 ............
Sioux Biochemical, Inc., 204 Third St. NW., Sioux
Center, IA 51250.
F.S.H.-P (follicle stimulating hormone) Powder for
Injection.
IV. Technical Amendments
We are also making several technical
amendments in part 558, which was
amended on December 27, 2016 (81 FR
94991), and February 24, 2017 (82 FR
11510), as part of the FDA Center for
Veterinary Medicine’s (CVM’s)
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13:27 May 09, 2017
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Judicious Use Initiative. These actions
are being taken to improve the accuracy
of the regulations.
This final rule is issued under Section
512(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C.360b(i)), which
requires Federal Register publication of
‘‘notice[s]. . . effective as a regulation,’’
of the conditions of use of approved
new animal drugs. This rule sets forth
technical amendments to the regulations
to codify recent actions on approved
new animal drug applications and
corrections to improve the accuracy of
the regulations, and as such does not
impose any burden on regulated
entities.
Although denominated a rule
pursuant to the Federal Food, Drug, and
Cosmetic Act, this document does not
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520.980
requested that FDA withdraw approval
of the NADAs listed in the following
table because the products are no longer
manufactured or marketed:
File No.
Elsewhere in this issue of the Federal
Register, FDA gave notice that approval
of NADA 009–505, and all supplements
and amendments thereto, is withdrawn,
effective May 22, 2017. Following this
withdrawal of approval, Sioux
Biochemical, Inc., is no longer the
sponsor of an approved application. As
provided in the regulatory text of this
document, the animal drug regulations
are amended to reflect this voluntary
withdrawal of approval.
522.1055
Laboratories, Inc., 8809 Ely Rd.,
Pensacola, FL 32514:
File No.
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524.1450
522.1450
520.1454
21 CFR section
522.1002
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.
Likewise, this is not a rule subject to
Executive Order 12866 which defines a
rule as ‘‘an agency statement of general
applicability and future effect, which
the agency intends to have the force and
effect of law, that is designed to
implement, interpret, or prescribe law
or policy or to describe the procedure or
practice requirements of an agency.’’ As
such, this document is also not subject
to Executive Order 12866.
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Federal Register / Vol. 82, No. 89 / Wednesday, May 10, 2017 / Rules and Regulations
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:
List of Subjects
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
PART 510—NEW ANIMAL DRUGS
21 CFR Parts 520, 522, and 524
1. The authority citation for part 510
continues to read as follows:
(c)(1), alphabetically add an entry for
‘‘Anzac Animal Health, LLC’’, and
remove the entry for ‘‘Nexcyon
Pharmaceuticals, Inc.’’; and in the table
in paragraph (c)(2), remove the entry for
‘‘050929’’, and numerically add an entry
for ‘‘086073.’’ The additions read as
follows:
■
Animal drugs.
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
*
2. Effective May 10, 2017, in
§ 510.600, in the table in paragraph
■
*
*
(c) * * *
(1) * * *
*
*
Drug labeler
code
Firm name and address
*
*
*
*
*
*
Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043 ........................................................................
*
*
*
*
*
*
086073
*
*
*
*
*
*
(2) * * *
Drug labeler
code
*
086073 ...........
Firm name and address
*
*
*
*
Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043.
*
*
§ 510.600
*
[Amended]
3. Effective May 22, 2017, in
§ 510.600, in the table in paragraph
(c)(1), remove the entry for ‘‘Sioux
Biochemical, Inc.’’ .’’; and in the table
in paragraph (c)(2), remove the entry for
‘‘063112’’.
■
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
4. The authority citation for part 520
continues to read as follows:
■
5. In § 520.48, in paragraph (b),
remove ‘‘013744’’ and in its place add
‘‘061623’’.
■
[Amended]
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[Amended]
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§ 522.90b
[Amended]
9. In § 522.90b, in paragraph (a),
remove ‘‘50, 100, or 250’’ and in its
place add ‘‘200, 250, or 400’’.
■
[Amended]
10. Effective May 22, 2017, in
§ 522.1002, remove paragraph (b); and
redesignate paragraph (c) as paragraph
(b).
§ 522.1055
[Amended]
11. In § 522.1055, in paragraph (b),
remove ‘‘Nos. 013744 and 061623’’ and
in its place add ‘‘No. 013744’’.
§ 522.1362
[Amended]
12. In § 522.1362, in paragraph (b),
remove ‘‘No. 050604’’ and in its place
add ‘‘Nos. 050604 and 086073’’.
■
7. In § 520.1454, in paragraph (b),
remove ‘‘000010’’ and in its place add
‘‘000859’’.
■
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Authority: 21 U.S.C. 360b.
■
6. In § 520.980, in paragraph (b),
remove ‘‘050929’’ and in its place add
‘‘055246’’.
■
§ 520.1454
8. The authority citation for part 522
continues to read as follows:
■
■
[Amended]
§ 520.980
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
§ 522.1002
Authority: 21 U.S.C. 360b.
§ 520.48
*
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§ 522.1450
[Amended]
13. In § 522.1450, in paragraph (b),
remove ‘‘000010’’ and in its place add
‘‘000859’’.
■
14. In § 522.1662a, revise paragraph
(e)(1); and in paragraph (e)(3)(i)(c),
revise the fifth sentence to read as
follows:
■
§ 522.1662a
injection.
Oxytetracycline hydrochloride
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*
*
*
*
(e) * * *
(1) Specifications. Each milliliter of
solution contains 100 milligrams of
oxytetracycline hydrochloride.
*
*
*
*
*
(3) * * *
(i) * * *
(c) * * * Exceeding the highest
recommended dose of 5 milligrams per
pound of body weight per day,
administering more than the
recommended number of treatments,
and/or exceeding 10 milliliters
intramuscularly or subcutaneously per
injection site in adult beef and dairy
cattle may result in antibiotic residues
beyond the withdrawal period. * * *
*
*
*
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Federal Register / Vol. 82, No. 89 / Wednesday, May 10, 2017 / Rules and Regulations
§ 522.2473
[Amended]
15. In § 522.2473, in paragraph (b),
remove ‘‘013744’’ and in its place add
‘‘061623’’.
■ 16. In § 522.2477, revise paragraph
(b)(2) and add paragraph (d)(4) to read
as follows:
■
§ 522.2477
estradiol.
Trenbolone acetate and
*
*
*
*
*
(b) * * *
(2) No. 000061 for use as in
paragraphs (d)(1)(i)(A), (d)(1)(i)(C),
(d)(1)(i)(D), (d)(1)(i)(G), (d)(1)(ii),
(d)(1)(iii), (d)(2)(i)(A), (d)(2)(i)(C),
(d)(2)(i)(D), (d)(2)(ii), (d)(2)(iii),
(d)(3)(i)(A), (d)(3)(ii), (d)(3)(iii), and
(d)(4) of this section.
*
*
*
*
*
(d) * * *
(4) Beef steers and heifers fed in
confinement for slaughter—(i) Amount.
Each extended- and delayed-release
implant contains 200 mg trenbolone
acetate and 20 mg estradiol (one implant
consisting of 10 pellets, each pellet
containing 20 mg trenbolone acetate and
2 mg estradiol) per implant dose.
(ii) Indications for use. For increased
rate of weight gain and improved feed
efficiency during 70 to 200 days after
implantation.
(iii) Limitations. Implant
subcutaneously in the ear only. Do not
use in lactating dairy cows or in animals
intended for subsequent breeding. Use
in these cattle may cause drug residues
in milk and/or in calves born to these
cows. Do not use in calves to be
processed for veal. A withdrawal period
has not been established for this product
Chlortetracycline
amount
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*
(xxiv) 25 to 2,800 to
provide 350 mg/
head/day.
*
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
17. The authority citation for part 524
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 524.1450
*
Lasalocid, 30 to
181.8.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
19. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
§ 558.4
*
[Amended]
20. In § 558.4, in paragraph (d), in the
Category I table, remove the row entry
for ‘‘Penicillin’’; and in the Category II
table, remove the row entry for
‘‘Sulfamethazine’’ the first time it
appears only along with the subsequent
entries for ‘‘Chlortetracycline’’ and
‘‘Penicillin’’.
■
*
§ 558.140
Jkt 241001
§ 558.115
Carbadox.
*
*
*
*
*
(d) * * *
(4) Carbadox may also be used in
combination with oxytetracycline as in
§ 558.450.
■ 23. Amend § 558.128 as follows:
■ a. In paragraph (b)(1), remove ‘‘50, 65,
or 100’’ and in its place add ‘‘50, 90, or
100’’;
■ b. In paragraphs (e)(1)(i) and (v), in the
‘‘Limitations’’ column, remove ‘‘Do not
feed to chickens producing eggs for
human consumption.’’ and in its place
add ‘‘For No. 066104: Do not feed to
chickens producing eggs for human
consumption.’’;
■ c. In paragraph (e)(3)(v), in the
‘‘Sponsor’’ column, add ‘‘054771’’
before ‘‘069254’’;
■ d. In paragraph (e)(4)(iii), in the
‘‘Indications for use’’ column, remove
‘‘anaplsmosis’’ and in its place add
‘‘anaplasmosis’’; and
■ e. Redesignate paragraphs (e)(4)(xxiv)
and (xxv) as paragraphs (e)(4)(xxv) and
(xxvi), respectively, and add new
paragraph (e)(4)(xxiv).
The addition reads as follows:
§ 558.128
*
Chlortetracycline.
*
*
(e) * * *
(4) * * *
*
*
*
*
Hand feed continuously at a rate of 350
mg chlortetracycline and 1 mg lasalocid
per 2.2 lb. body weight daily to cattle
with a maximum of 360 mg of lasalocid
per head per day. Do not allow horses or
other equines access to feeds containing
lasalocid. No withdrawal period is required. A withdrawal period has not been
established for this product in pre-ruminating calves. Do not use in calves to be
processed for veal. See § 558.311(d) of
this chapter. Chlortetracycline and
lasalocid as provided by No. 054771 in
§ 510.600(c) of this chapter.
*
[Amended]
24. In § 558.140, in paragraph (b)(1),
remove ‘‘(d)(1)’’ and in its place add
13:27 May 09, 2017
21. In § 558.76, remove and reserve
paragraph (e)(1)(vii).
■ 22. In § 558.115, revise paragraph
(d)(4) to read as follows:
■
*
*
Beef cattle weighing under 700
pounds: For control of active
infection of anaplasmosis
caused
by
Anaplasma
marginale
susceptible
to
chlortetracycline; and for the
control of coccidiosis caused
by Eimeria bovis and E.
zuernii.
■
VerDate Sep<11>2014
[Amended]
Limitations
*
*
§ 558.76
Indications for use
*
*
[Amended]
18. In § 524.1450, in paragraph (b)(1),
remove ‘‘000010’’ and in its place add
‘‘000859’’.
■
Combination in
grams/ton
*
*
in pre-ruminating calves. Effectiveness
and animal safety in veal calves have
not been established. Not approved for
repeated implantation (reimplantation)
with this or any other cattle ear implant
during the production phase(s)
identified on labeling (beef steers and
heifers fed in confinement for slaughter)
unless otherwise indicated on labeling
because safety and effectiveness have
not been evaluated.
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Sponsor
*
*
054771
*
‘‘(e)(1)’’; and in paragraph (b)(2), remove
‘‘(d)(2)’’ and in its place add ‘‘(e)(2)’’.
25. In § 558.325, redesignate
paragraphs (e)(2)(vii) to (xvi) as
■
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§ 558.325
paragraphs (e)(2)(viii) to (xvii),
respectively, and add new paragraph
(e)(2)(vii) to read as follows:
*
Lincomycin.
*
*
(e) * * *
*
(2) * * *
*
Lincomycin grams/ton
Combination in
grams/ton
Indications for use
Limitations
*
(vii) 40 .........................
*
Pyrantel, 800 ............
*
*
For the treatment and/or control
of swine dysentery; for removal and control of large
roundworm (Ascaris suum)
and
nodular
worm
(Oesophagostomum spp.) infections.
*
*
Feed as a single therapeutic treatment at a
rate of 1 lb of feed per 40 lb of body
weight for animals up to 200 lb and 5 lb
of feed per head for animals over 200 lb.
Not to be fed to swine that weigh more
than 250 pounds. Withdraw 24 hours
prior to slaughter. See paragraph (d) of
this section. Lincomycin as provided by
No. 054771; pyrantel as provided by No.
066104 in § 510.600(c) of this chapter.
*
*
*
26. In § 558.366, revise paragraph (e)
to read as follows:
■
§ 558.366
Nicarbazin.
*
*
*
*
(e) Nicarbazin may also be used in
combination with:
(1)–(3) [Reserved]
(4) Lincomycin as in § 558.325.
[Amended]
27. In § 558.485, remove paragraph
(e)(1)(iv).
■ 28. In § 558.550, add paragraph (d)(5)
to read as follows:
■
§ 558.550
*
29. Amend § 558.625 as follows:
a. Revise paragraph (d)(2);
b. Add paragraphs (d)(4) and (5);
c. In paragraphs (e)(2)(iv), (v), (viii),
(x), (xii), and (xiii), in the ‘‘Limitations’’
column, add a new sentence ‘‘See
§ 558.355(d) in this chapter.’’ between
the fourth and fifth sentences;
■ d. In paragraph (e)(2)(vi), in the
‘‘Limitations’’ column, add a new
sentence ‘‘See § 558.355(d) in this
chapter.’’ between the seventh and
eighth sentences; and
■ e. In paragraphs (e)(2)(vii), (ix), (xi),
(xiv), and (xv), in the ‘‘Limitations’’
column, add a new sentence ‘‘See
§ 558.355(d) in this chapter.’’ between
the fifth and sixth sentences.
The revisions and additions read as
follows:
■
■
■
■
*
§ 558.485
*
Salinomycin.
*
*
*
*
*
(d) * * *
(5) Salinomycin may also be used in
combination with:
(i)–(ii) [Reserved]
(iii) Chlortetracycline as in § 558.128.
(iv) Lincomycin as in § 558.325.
§ 558.625
*
*
*
(d) * * *
*
*
*
*
066104
*
(2) The expiration date of VFDs for
tylosin medicated feeds must not exceed
6 months from the date of issuance.
VFDs for tylosin shall not be refilled.
*
*
*
*
*
(4) Tylosin liquid Type B medicated
feeds must bear an expiration date of 31
days after the date of manufacture.
(5) Do not use tylosin liquid Type B
medicated feeds in any liquid feed
containing sodium metabisulfite or in
any finished feed (supplement,
concentrate, or complete feed)
containing in excess of 2 percent
bentonite.
*
*
*
*
*
30. In § 558.635, revise paragraph
(e)(1) to read as follows:
■
§ 558.635
Tylosin.
Sponsors
*
Virginiamycin.
*
*
*
*
(e) Conditions of use—(1) Chickens—
Combination in
grams/ton
Indications for use
Limitations
(i) 20 ...........................
...................................
066104
Amprolium 72.6 to
113.5.
Amprolium 113.5 to
227.
For field conditions where only E. tenella is
the major problem, feed continuously as
the sole ration. Use as the sole source of
amprolium. Do not use in feeds containing bentonite. Not for use in laying
chickens. Amprolium as provided by No.
016592 in § 510.600(c) of this chapter.
For most field conditions as they exist
under modern management practices,
feed 113.5 g/ton amprolium continuously.
Where severe coccidiosis conditions
exist, feed 227 g/ton. Use as the sole
source of amprolium. Do not use in
feeds containing bentonite. Not for use in
laying chickens. Amprolium as provided
by No. 016592 in § 510.600(c) of this
chapter.
066104
(iii) 20 .........................
Broiler chickens: For prevention
of necrotic enteritis caused by
Clostridium perfringens susceptible to virginiamycin.
Broiler chickens: For prevention
of necrotic enteritis caused by
Clostridium perfringens susceptible to virginiamycin; and
for the prevention of coccidiosis caused by Eimeria
tenella.
Broiler chickens: For prevention
of necrotic enteritis caused by
Clostridium perfringens susceptible to virginiamycin; and
for the prevention of coccidiosis where immunity to coccidiosis is not desired.
Not for use in layers ....................................
(ii) 20 ..........................
jstallworth on DSK7TPTVN1PROD with RULES
Virginiamycin
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066104
Federal Register / Vol. 82, No. 89 / Wednesday, May 10, 2017 / Rules and Regulations
21693
Combination in
grams/ton
Indications for use
Limitations
(iv) 20 .........................
Diclazuril 0.91 ...........
016592
Lasalocid 68 to 113 ..
Feed continuously as the sole ration. Do
not feed to laying chickens. For broiler or
fryer chickens only. Lasalocid as provided by No. 054771 in § 510.600(c) of
this chapter.
066104
(vi) 20 .........................
Monensin 90 to 110
Feed continuously as the sole ration. Do
not feed to laying chickens. See
§ 558.355(d) in this chapter. Monensin as
provided by No. 058198 in § 510.600(c)
of this chapter.
066104
(vii) 20 ........................
Salinomycin 40 to 60
Feed continuously as the sole ration. Do
not feed to chickens over 16 weeks of
age. Do not feed to laying chickens. Not
approved for use with pellet binders. May
be fatal if accidentally fed to adult turkeys or horses. Salinomycin as provided
by No. 016592 in § 510.600(c) of this
chapter.
........................
(viii) 20 .......................
Semduramicin 22.7 ..
Feed continuously as the sole ration. Do
not feed to laying hens. Semduramicin
as provided by No. 066104 in
§ 510.600(c) of this chapter.
066104
(ix) 20 .........................
Semduramicin (biomass) 22.7.
Broiler chickens: For prevention
of necrotic enteritis caused by
Clostridium perfringens susceptible to virginiamycin; and
for the prevention of coccidiosis caused by Eimeria
tenella,
E.
necatrix,
E.
acervulina, E. brunetti, E.
mitis (mivati), and E. maxima.
Because diclazuril is effective
against E. maxima late in its
life cycle, subclinical intestinal
lesions may be present for a
short time after infection.
Diclazuril was shown in studies to reduce lesions scores
and improve performance and
health of birds challenged with
E. maxima.
Broiler chickens: For prevention
of necrotic enteritis caused by
Clostridium perfringens susceptible to virginiamycin; and
for the prevention of coccidiosis caused by Eimeria
tenella,
E.
necatrix,
E.
acervulina, E. brunetti, E.
mivati, and E. maxima.
Broiler chickens: For prevention
of necrotic enteritis caused by
Clostridium perfringens susceptible to virginiamycin; and
as an aid in the prevention of
coccidiosis caused by Eimeria
necatrix,
E.
tenella,
E.
acervulina, E. brunetti, E.
maxima, and E. mivati.
Broiler chickens: For prevention
of necrotic enteritis caused by
Clostridium perfringens susceptible to virginiamycin; and
for the prevention of coccidiosis caused by Eimeria
tenella,
E.
necatrix,
E.
acervulina, E. maxima, E.
brunetti, and E. mivati.
Broiler chickens: For prevention
of necrotic enteritis caused by
Clostridium perfringens susceptible to virginiamycin; and
for the prevention of coccidiosis caused by Eimeria
acervulina, E. brunetti, E.
maxima, E mivati/mitis, E.
necatrix, and E. tenella.
Broiler chickens: For prevention
of necrotic enteritis caused by
Clostridium perfringens susceptible to virginiamycin; and
for the prevention of coccidiosis caused by Eimeria
acervulina, E. brunetti, E.
maxima, E mivati/mitis, E.
necatrix, and E. tenella.
Feed continuously as the sole ration. Do
not use in hens producing eggs for
human food. Diclazuril as provided by
No. 016592 in § 510.600(c) of this chapter.
(v) 20 ..........................
jstallworth on DSK7TPTVN1PROD with RULES
Virginiamycin
grams/ton
Feed continuously as the sole ration. Withdraw 1 day before slaughter. Do not feed
to laying hens. Semduramicin as provided by No. 066104 in § 510.600(c) of
this chapter.
066104
*
*
*
*
*
§ 558.680
31. In § 558.680, remove paragraph (e)
and add paragraph (d)(3) to read as
follows:
■
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*
*
*
*
*
(d) * * *
(3) Zoalene may also be used in
combination with:
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Sponsors
(i)–(ii) [Reserved]
(iii) Lincomycin as in § 558.325.
E:\FR\FM\10MYR1.SGM
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21694
Federal Register / Vol. 82, No. 89 / Wednesday, May 10, 2017 / Rules and Regulations
Dated: May 4, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[FR Doc. 2017–09364 Filed 5–9–17; 8:45 am]
[Docket No. FR–5986–C–02]
24 CFR Part 15
BILLING CODE 4164–01–P
RIN 2501–AD81
Revision of Freedom of Information
Act Regulation; Correction
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
21 CFR Part 522
New Animal Drugs; Withdrawal of
Approval of a New Animal Drug
Application
Food and Drug Administration,
HHS.
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of a new animal drug
application (NADA). This action is
being taken at the sponsors’ request
because these products are no longer
manufactured or marketed.
DATES: Withdrawal of approval is
effective May 22, 2017.
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5761,
sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Sioux
Biochemical, Inc., 204 Third St. NW.,
Sioux Center, IA 51250 has requested
that FDA withdraw approval of NADA
009–505 for F.S.H.-P (follicle
stimulating hormone) Powder for
Injection because the product is no
longer manufactured or marketed.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
Veterinary Medicine, and in accordance
with § 514.116 Notice of withdrawal of
approval of application (21 CFR
514.116), notice is given that approval
of NADA 009–505, and all supplements
and amendments thereto, is hereby
withdrawn, effective May 22, 2017.
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.
jstallworth on DSK7TPTVN1PROD with RULES
SUMMARY:
Dated: May 4, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–09365 Filed 5–9–17; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
13:27 May 09, 2017
On January 12, 2017, HUD
issued a final rule amending HUD’s
Freedom of Information Act (FOIA)
regulation to implement the FOIA
Improvement Act of 2016, which
enacted a range of procedural changes,
including a change to the procedures for
withholding information and an
amendment to one of the nine FOIA
exemptions that authorizes an agency to
withhold various records from
disclosure. After publication, HUD
discovered that a portion of the
regulation was not published as
intended. Specifically, the published
rule deleted several of the nine statutory
FOIA disclosure exemptions and
duplicated another. HUD also noticed
minor technical changes required
elsewhere in its regulations. This
document corrects HUD’s January 12,
2017, final rule and makes the minor
technical changes.
DATES: Effective: May 10, 2017.
FOR FURTHER INFORMATION CONTACT:
Helen Goff Foster, Chief Administrative
Officer, Office of Administration,
Department of Housing and Urban
Development, 451 7th Street SW., Room
6100, Washington, DC 20410–0500,
telephone number 1–202–402–6838
(this is not a toll-free number). Hearingor speech-impaired individuals may
access this number via TTY by calling
the toll-free Federal Relay Service at
telephone number 1–800–877–8339
(this is a toll-free number).
SUPPLEMENTARY INFORMATION: On
January 12, 2017 (82 FR 3623), HUD
issued a final rule amending HUD’s
Freedom of Information Act (FOIA)
regulation at 24 CFR part 15 to
implement the FOIA Improvement Act
of 2016 (Pub. L. 114–185, approved June
30, 2016) (2016 Act). Upon review of the
published rule, HUD determined that
§ 15.107 was not published as intended.
The amendatory instruction excluded
three of the nine statutory FOIA
exemptions (5 U.S.C. 552(b)) and
included a duplicate exemption in
§ 15.107(b).
HUD’s January 12, 2017, final rule
sought to restructure § 15.107 by adding
paragraph (a) to provide that HUD shall
SUMMARY:
[Docket No. FDA–2017–N–0002]
AGENCY:
Office of the Secretary, HUD.
Final rule; correction.
AGENCY:
Food and Drug Administration
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withhold information only if it is
reasonably foreseeable that disclosure
would harm an interest protected by an
exemption, or if disclosure is prohibited
by law. HUD also sought to redesignate
the undesignated introductory text as
paragraph (b), redesignate paragraphs (a)
through (i) as (b)(1) through (b)(9), and
amend redesignated paragraph (b)(5),
the deliberative process privilege, to add
a sunset clause after 25 years.
As discussed above, HUD’s final rule
did not accurately restructure § 15.107
as intended. This final rule restates in
whole § 15.107 to reflect the changes
required by the 2016 Act to the
deliberative process privilege
exemption, and restores all other FOIA
disclosure exemptions.
In addition, HUD is fixing an
incorrect Web site link in § 15.101,
removing two misplaced words in
§ 15.105, and correcting the number of
days a FOIA requester has to appeal an
adverse determination in § 15.109(a),
consistent with the change HUD made
in § 15.105(d)(2)(iv).
List of Subjects in 24 CFR Part 15
Classified information, Courts,
Freedom of information, Government
employees, Reporting and
recordkeeping requirements.
Accordingly, 24 CFR part 15 is
corrected by making the following
correcting amendments:
PART 15—PUBLIC ACCESS TO HUD
RECORDS UNDER THE FREEDOM OF
INFORMATION ACT AND TESTIMONY
AND PRODUCTION OF INFORMATION
BY HUD EMPLOYEES
1. The authority for part 15 continues
to read as follows:
■
Authority: 42 U.S.C. 3535(d), 5 U.S.C. 552.
§ 15.101
[Amended]
2. In § 15.101(b)(2), remove the link
‘‘https://www/data/gov’’ and add in its
place the link ‘‘https://www.data.gov’’.
■
§ 15.105
[Amended]
3. In § 15.105, in paragraph (d)(2)(iv)
remove the word ‘‘and’’ and in
paragraph (d)(2)(v) remove the word
‘‘and’’.
■ 4. Revise § 15.107 to read as follows:
■
§ 15.107 Documents generally protected
from disclosure.
(a) HUD shall withhold information
only if HUD reasonably foresees that
disclosure would harm an interest
protected by an exemption as provided
in paragraph (b) of this section, or
disclosure is prohibited by law. HUD
will consider whether partial disclosure
of information is possible whenever
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]]>Agencies
[Federal Register Volume 82, Number 89 (Wednesday, May 10, 2017)]
[Rules and Regulations]
[Pages 21688-21694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09364]
[[Page 21688]]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and 558
[Docket No. FDA-2017-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications; Changes of
Sponsorship
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; correcting amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during January and February 2017. FDA is also
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable. The
animal drug regulations are also being amended to reflect several
changes of sponsorship of applications and to make correcting
amendments to improve the accuracy of the regulations.
DATES: This rule is effective May 10, 2017, except for amendatory
instruction 3 to 21 CFR 510.600, and amendatory instruction 10 to 21
CFR 522.1002, which are effective May 22, 2017.
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 an ANADA during January and February 2017, as
listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents may be seen in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4
p.m., Monday through Friday. Persons with access to the Internet may
obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and
patent information may be accessed in FDA's publication, Approved
Animal Drug Products Online (Green Book) at: https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
Table 1--Original and Supplemental NADAs and ANADAs Approved During January and February 2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
Approval date File No. Sponsor Product name Species Effect of the action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
January 13, 2017............ 141-468 Phibro Animal Health STAFAC Chickens............. Original approval FOI Summary.
Corp., GlenPointe (virginiamycin) for prevention of
Centre East, 3d plus BIO-COX necrotic enteritis
Floor, 300 Frank W. (salinomycin) and coccidiosis in
Burr Blvd., Suite combination drug broiler chickens.
21, Teaneck, NJ Type C medicated
07666. feeds.
January 13, 2017............ 141-469 Phibro Animal Health STAFAC Chickens............. Original approval FOI Summary.
Corp., GlenPointe (virginiamycin) for prevention of
Centre East, 3d plus AMPROL necrotic enteritis
Floor, 300 Frank W. (amprolium) and coccidiosis in
Burr Blvd., Suite combination drug broiler chickens.
21, Teaneck, NJ Type C medicated
07666. feeds.
January 13, 2017............ 141-470 Phibro Animal Health STAFAC Chickens............. Original approval FOI Summary.
Corp., GlenPointe (virginiamycin) for prevention of
Centre East, 3d plus AVATEC necrotic enteritis
Floor, 300 Frank W. (lasalocid) and coccidiosis in
Burr Blvd., Suite combination drug broiler chickens.
21, Teaneck, NJ Type C medicated
07666. feeds.
January 13, 2017............ 141-472 Huvepharma AD, 5th STAFAC Chickens............. Original approval FOI Summary.
Floor, 3A Nikolay (virginiamycin) for prevention of
Haytov Str.,1113 plus CLINACOX necrotic enteritis
Sophia, Bulgaria. (diclazuril) and coccidiosis in
combination drug broiler chickens.
Type C medicated
feeds.
February 13, 2017........... 141-445 Intervet, Inc., 2 REVALOR-XR Cattle............... Original approval FOI Summary; EA/
Giralda (trenbolone acetate for increased rate FONSI.\1\
Farms,Madison, NJ and estradiol) of weight gain and
07940. Extended-Release improved feed
Implant. efficiency during
70 to 200 days
after implantation
in beef steers and
heifers fed in
confinement for
slaughter.
February 17, 2017........... 200-609 Anzac Animal Health, DIROBAN (melarsomine Dogs................. Original approval as FOI Summary.
LLC, 218 Millwell dihydrochloride) a generic copy of
Dr., Suite B, Powder for NADA 141-042.
Maryland Heights, Injection.
MO 63043.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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).
Following the approval of ANADA 200-609, Anzac Animal Health, LLC
will now be included in the lists of sponsors of approved applications
in Sec. 510.600(c) (21 CFR 510.600(c)).
II. Changes of Sponsorship
Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St.
Joseph, MO 64506-2002 has informed FDA that it has transferred
ownership of, and all rights and interest in, the following
applications to Bayer HealthCare LLC, Animal Health Division, P.O. Box
390, Shawnee Mission, KS 66201:
[[Page 21689]]
----------------------------------------------------------------------------------------------------------------
File No. Product name 21 CFR section
----------------------------------------------------------------------------------------------------------------
141-099............................. CYDECTIN (moxidectin) Pour-On for Beef and Dairy Cattle. 524.1450
141-220............................. CYDECTIN (moxidectin) Injectable Solution for Beef and 522.1450
Nonlactating Dairy Cattle.
141-247............................. CYDECTIN (moxidectin) Oral Drench for Sheep............. 520.1454
----------------------------------------------------------------------------------------------------------------
Ceva Sante Animale, 10 Avenue de la Ballasti[egrave]re, 33500
Libourne, France has informed FDA that it has transferred ownership of,
and all rights and interest in, the following applications to Cross
Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland:
----------------------------------------------------------------------------------------------------------------
File No. Product name 21 CFR section
----------------------------------------------------------------------------------------------------------------
141-420............................. TILDREN (tiludronate disodium) Powder for Infusion...... 522.2473
200-481............................. ALTRESYN (altrenogest) Solution 0.22%................... 520.48
----------------------------------------------------------------------------------------------------------------
Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24,
Ireland has informed FDA that it has transferred ownership of, and all
rights and interest in, the following application to Ceva Sante
Animale, 10 Avenue de la Ballasti[egrave]re, 33500 Libourne, France:
----------------------------------------------------------------------------------------------------------------
File No. Product name 21 CFR section
----------------------------------------------------------------------------------------------------------------
200-587............................. FERROFORTE (gleptoferron) Solution, 200 mg/mL........... 522.1055
----------------------------------------------------------------------------------------------------------------
Nexcyon Pharmaceuticals, Inc., P.O. Box 259158, Madison, WI 53725
has informed FDA that it has transferred ownership of, and all rights
and interest in, the following applications to Pegasus Laboratories,
Inc., 8809 Ely Rd., Pensacola, FL 32514:
----------------------------------------------------------------------------------------------------------------
File No. Product name 21 CFR section
----------------------------------------------------------------------------------------------------------------
141-272............................. RECONCILE (fluoxetine hydrochloride) Chewable Tablets... 520.980
----------------------------------------------------------------------------------------------------------------
Accordingly, the animal drug regulations are being amended to
reflect these changes of sponsorship. Following this withdrawal of
approval, Nexcyon Pharmaceuticals, Inc. is no longer the sponsor of an
approved application. Accordingly, it will be removed from the list of
sponsors of approved applications in Sec. 510.600(c).
III. Withdrawals of Approval
In addition, during January and February 2017, the following
sponsor requested that FDA withdraw approval of the NADAs listed in the
following table because the products are no longer manufactured or
marketed:
------------------------------------------------------------------------
File No. Sponsor Product name 21 CFR section
------------------------------------------------------------------------
009-505............. Sioux F.S.H.-P 522.1002
Biochemical, (follicle
Inc., 204 stimulating
Third St. NW., hormone)
Sioux Center, Powder for
IA 51250. Injection.
------------------------------------------------------------------------
Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADA 009-505, and all supplements and amendments
thereto, is withdrawn, effective May 22, 2017. Following this
withdrawal of approval, Sioux Biochemical, Inc., is no longer the
sponsor of an approved application. As provided in the regulatory text
of this document, the animal drug regulations are amended to reflect
this voluntary withdrawal of approval.
IV. Technical Amendments
We are also making several technical amendments in part 558, which
was amended on December 27, 2016 (81 FR 94991), and February 24, 2017
(82 FR 11510), as part of the FDA Center for Veterinary Medicine's
(CVM's) Judicious Use Initiative. These actions are being taken to
improve the accuracy of the regulations.
This final rule is issued under Section 512(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.360b(i)), which requires Federal
Register publication of ``notice[s]. . . effective as a regulation,''
of the conditions of use of approved new animal drugs. This rule sets
forth technical amendments to the regulations to codify recent actions
on approved new animal drug applications and corrections to improve the
accuracy of the regulations, and as such does not impose any burden on
regulated entities.
Although denominated a rule pursuant to the Federal Food, Drug, and
Cosmetic Act, this document 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. Likewise, this is not a rule
subject to Executive Order 12866 which defines a rule as ``an agency
statement of general applicability and future effect, which the agency
intends to have the force and effect of law, that is designed to
implement, interpret, or prescribe law or policy or to describe the
procedure or practice requirements of an agency.'' As such, this
document is also not subject to Executive Order 12866.
[[Page 21690]]
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, and 524
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
520, 522, 524, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for part 510 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. Effective May 10, 2017, in Sec. 510.600, in the table in paragraph
(c)(1), alphabetically add an entry for ``Anzac Animal Health, LLC'',
and remove the entry for ``Nexcyon Pharmaceuticals, Inc.''; and in the
table in paragraph (c)(2), remove the entry for ``050929'', and
numerically add an entry for ``086073.'' The additions 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
------------------------------------------------------------------------
* * * * * * *
Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, 086073
Maryland Heights, MO 63043.............................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
086073....................... Anzac Animal Health, LLC, 218 Millwell
Dr., Suite B, Maryland Heights, MO
63043.
* * * * * * *
------------------------------------------------------------------------
Sec. 510.600 [Amended]
0
3. Effective May 22, 2017, in Sec. 510.600, in the table in paragraph
(c)(1), remove the entry for ``Sioux Biochemical, Inc.'' .''; and in
the table in paragraph (c)(2), remove the entry for ``063112''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
4. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.48 [Amended]
0
5. In Sec. 520.48, in paragraph (b), remove ``013744'' and in its
place add ``061623''.
Sec. 520.980 [Amended]
0
6. In Sec. 520.980, in paragraph (b), remove ``050929'' and in its
place add ``055246''.
Sec. 520.1454 [Amended]
0
7. In Sec. 520.1454, in paragraph (b), remove ``000010'' and in its
place add ``000859''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
8. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.90b [Amended]
0
9. In Sec. 522.90b, in paragraph (a), remove ``50, 100, or 250'' and
in its place add ``200, 250, or 400''.
Sec. 522.1002 [Amended]
0
10. Effective May 22, 2017, in Sec. 522.1002, remove paragraph (b);
and redesignate paragraph (c) as paragraph (b).
Sec. 522.1055 [Amended]
0
11. In Sec. 522.1055, in paragraph (b), remove ``Nos. 013744 and
061623'' and in its place add ``No. 013744''.
Sec. 522.1362 [Amended]
0
12. In Sec. 522.1362, in paragraph (b), remove ``No. 050604'' and in
its place add ``Nos. 050604 and 086073''.
Sec. 522.1450 [Amended]
0
13. In Sec. 522.1450, in paragraph (b), remove ``000010'' and in its
place add ``000859''.
0
14. In Sec. 522.1662a, revise paragraph (e)(1); and in paragraph
(e)(3)(i)(c), revise the fifth sentence to read as follows:
Sec. 522.1662a Oxytetracycline hydrochloride injection.
* * * * *
(e) * * *
(1) Specifications. Each milliliter of solution contains 100
milligrams of oxytetracycline hydrochloride.
* * * * *
(3) * * *
(i) * * *
(c) * * * Exceeding the highest recommended dose of 5 milligrams
per pound of body weight per day, administering more than the
recommended number of treatments, and/or exceeding 10 milliliters
intramuscularly or subcutaneously per injection site in adult beef and
dairy cattle may result in antibiotic residues beyond the withdrawal
period. * * *
* * * * *
[[Page 21691]]
Sec. 522.2473 [Amended]
0
15. In Sec. 522.2473, in paragraph (b), remove ``013744'' and in its
place add ``061623''.
0
16. In Sec. 522.2477, revise paragraph (b)(2) and add paragraph (d)(4)
to read as follows:
Sec. 522.2477 Trenbolone acetate and estradiol.
* * * * *
(b) * * *
(2) No. 000061 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(C),
(d)(1)(i)(D), (d)(1)(i)(G), (d)(1)(ii), (d)(1)(iii), (d)(2)(i)(A),
(d)(2)(i)(C), (d)(2)(i)(D), (d)(2)(ii), (d)(2)(iii), (d)(3)(i)(A),
(d)(3)(ii), (d)(3)(iii), and (d)(4) of this section.
* * * * *
(d) * * *
(4) Beef steers and heifers fed in confinement for slaughter--(i)
Amount. Each extended- and delayed-release implant contains 200 mg
trenbolone acetate and 20 mg estradiol (one implant consisting of 10
pellets, each pellet containing 20 mg trenbolone acetate and 2 mg
estradiol) per implant dose.
(ii) Indications for use. For increased rate of weight gain and
improved feed efficiency during 70 to 200 days after implantation.
(iii) Limitations. Implant subcutaneously in the ear only. Do not
use in lactating dairy cows or in animals intended for subsequent
breeding. Use in these cattle may cause drug residues in milk and/or in
calves born to these cows. Do not use in calves to be processed for
veal. A withdrawal period has not been established for this product in
pre-ruminating calves. Effectiveness and animal safety in veal calves
have not been established. Not approved for repeated implantation
(reimplantation) with this or any other cattle ear implant during the
production phase(s) identified on labeling (beef steers and heifers fed
in confinement for slaughter) unless otherwise indicated on labeling
because safety and effectiveness have not been evaluated.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
17. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1450 [Amended]
0
18. In Sec. 524.1450, in paragraph (b)(1), remove ``000010'' and in
its place add ``000859''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
19. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
Sec. 558.4 [Amended]
0
20. In Sec. 558.4, in paragraph (d), in the Category I table, remove
the row entry for ``Penicillin''; and in the Category II table, remove
the row entry for ``Sulfamethazine'' the first time it appears only
along with the subsequent entries for ``Chlortetracycline'' and
``Penicillin''.
Sec. 558.76 [Amended]
0
21. In Sec. 558.76, remove and reserve paragraph (e)(1)(vii).
0
22. In Sec. 558.115, revise paragraph (d)(4) to read as follows:
Sec. 558.115 Carbadox.
* * * * *
(d) * * *
(4) Carbadox may also be used in combination with oxytetracycline
as in Sec. 558.450.
0
23. Amend Sec. 558.128 as follows:
0
a. In paragraph (b)(1), remove ``50, 65, or 100'' and in its place add
``50, 90, or 100'';
0
b. In paragraphs (e)(1)(i) and (v), in the ``Limitations'' column,
remove ``Do not feed to chickens producing eggs for human
consumption.'' and in its place add ``For No. 066104: Do not feed to
chickens producing eggs for human consumption.'';
0
c. In paragraph (e)(3)(v), in the ``Sponsor'' column, add ``054771''
before ``069254'';
0
d. In paragraph (e)(4)(iii), in the ``Indications for use'' column,
remove ``anaplsmosis'' and in its place add ``anaplasmosis''; and
0
e. Redesignate paragraphs (e)(4)(xxiv) and (xxv) as paragraphs
(e)(4)(xxv) and (xxvi), respectively, and add new paragraph
(e)(4)(xxiv).
The addition reads as follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(e) * * *
(4) * * *
----------------------------------------------------------------------------------------------------------------
Combination in Indications for
Chlortetracycline amount grams/ton use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(xxiv) 25 to 2,800 to provide Lasalocid, 30 to Beef cattle Hand feed continuously 054771
350 mg/head/day. 181.8. weighing under at a rate of 350 mg
700 pounds: For chlortetracycline and
control of active 1 mg lasalocid per 2.2
infection of lb. body weight daily
anaplasmosis to cattle with a
caused by maximum of 360 mg of
Anaplasma lasalocid per head per
marginale day. Do not allow
susceptible to horses or other
chlortetracycline equines access to
; and for the feeds containing
control of lasalocid. No
coccidiosis withdrawal period is
caused by Eimeria required. A withdrawal
bovis and E. period has not been
zuernii. established for this
product in pre-
ruminating calves. Do
not use in calves to
be processed for veal.
See Sec. 558.311(d)
of this chapter.
Chlortetracycline and
lasalocid as provided
by No. 054771 in Sec.
510.600(c) of this
chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Sec. 558.140 [Amended]
0
24. In Sec. 558.140, in paragraph (b)(1), remove ``(d)(1)'' and in its
place add ``(e)(1)''; and in paragraph (b)(2), remove ``(d)(2)'' and in
its place add ``(e)(2)''.
0
25. In Sec. 558.325, redesignate paragraphs (e)(2)(vii) to (xvi) as
[[Page 21692]]
paragraphs (e)(2)(viii) to (xvii), respectively, and add new paragraph
(e)(2)(vii) to read as follows:
Sec. 558.325 Lincomycin.
* * * * *
(e) * * *
(2) * * *
----------------------------------------------------------------------------------------------------------------
Combination in Indications for
Lincomycin grams/ton grams/ton use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(vii) 40....................... Pyrantel, 800..... For the treatment Feed as a single 066104
and/or control of therapeutic treatment
swine dysentery; at a rate of 1 lb of
for removal and feed per 40 lb of body
control of large weight for animals up
roundworm to 200 lb and 5 lb of
(Ascaris suum) feed per head for
and nodular worm animals over 200 lb.
(Oesophagostomum Not to be fed to swine
spp.) infections. that weigh more than
250 pounds. Withdraw
24 hours prior to
slaughter. See
paragraph (d) of this
section. Lincomycin as
provided by No.
054771; pyrantel as
provided by No. 066104
in Sec. 510.600(c)
of this chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
0
26. In Sec. 558.366, revise paragraph (e) to read as follows:
Sec. 558.366 Nicarbazin.
* * * * *
(e) Nicarbazin may also be used in combination with:
(1)-(3) [Reserved]
(4) Lincomycin as in Sec. 558.325.
Sec. 558.485 [Amended]
0
27. In Sec. 558.485, remove paragraph (e)(1)(iv).
0
28. In Sec. 558.550, add paragraph (d)(5) to read as follows:
Sec. 558.550 Salinomycin.
* * * * *
(d) * * *
(5) Salinomycin may also be used in combination with:
(i)-(ii) [Reserved]
(iii) Chlortetracycline as in Sec. 558.128.
(iv) Lincomycin as in Sec. 558.325.
0
29. Amend Sec. 558.625 as follows:
0
a. Revise paragraph (d)(2);
0
b. Add paragraphs (d)(4) and (5);
0
c. In paragraphs (e)(2)(iv), (v), (viii), (x), (xii), and (xiii), in
the ``Limitations'' column, add a new sentence ``See Sec. 558.355(d)
in this chapter.'' between the fourth and fifth sentences;
0
d. In paragraph (e)(2)(vi), in the ``Limitations'' column, add a new
sentence ``See Sec. 558.355(d) in this chapter.'' between the seventh
and eighth sentences; and
0
e. In paragraphs (e)(2)(vii), (ix), (xi), (xiv), and (xv), in the
``Limitations'' column, add a new sentence ``See Sec. 558.355(d) in
this chapter.'' between the fifth and sixth sentences.
The revisions and additions read as follows:
Sec. 558.625 Tylosin.
* * * * *
(d) * * *
(2) The expiration date of VFDs for tylosin medicated feeds must
not exceed 6 months from the date of issuance. VFDs for tylosin shall
not be refilled.
* * * * *
(4) Tylosin liquid Type B medicated feeds must bear an expiration
date of 31 days after the date of manufacture.
(5) Do not use tylosin liquid Type B medicated feeds in any liquid
feed containing sodium metabisulfite or in any finished feed
(supplement, concentrate, or complete feed) containing in excess of 2
percent bentonite.
* * * * *
0
30. In Sec. 558.635, revise paragraph (e)(1) to read as follows:
Sec. 558.635 Virginiamycin.
* * * * *
(e) Conditions of use--(1) Chickens--
----------------------------------------------------------------------------------------------------------------
Combination in Indications for
Virginiamycin grams/ton grams/ton use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 20......................... .................. Broiler chickens: Not for use in layers.. 066104
For prevention of
necrotic
enteritis caused
by Clostridium
perfringens
susceptible to
virginiamycin.
(ii) 20........................ Amprolium 72.6 to Broiler chickens: For field conditions 066104
113.5. For prevention of where only E. tenella
necrotic is the major problem,
enteritis caused feed continuously as
by Clostridium the sole ration. Use
perfringens as the sole source of
susceptible to amprolium. Do not use
virginiamycin; in feeds containing
and for the bentonite. Not for use
prevention of in laying chickens.
coccidiosis Amprolium as provided
caused by Eimeria by No. 016592 in Sec.
tenella. 510.600(c) of this
chapter.
(iii) 20....................... Amprolium 113.5 to Broiler chickens: For most field 066104
227. For prevention of conditions as they
necrotic exist under modern
enteritis caused management practices,
by Clostridium feed 113.5 g/ton
perfringens amprolium
susceptible to continuously. Where
virginiamycin; severe coccidiosis
and for the conditions exist, feed
prevention of 227 g/ton. Use as the
coccidiosis where sole source of
immunity to amprolium. Do not use
coccidiosis is in feeds containing
not desired. bentonite. Not for use
in laying chickens.
Amprolium as provided
by No. 016592 in Sec.
510.600(c) of this
chapter.
[[Page 21693]]
(iv) 20........................ Diclazuril 0.91... Broiler chickens: Feed continuously as 016592
For prevention of the sole ration. Do
necrotic not use in hens
enteritis caused producing eggs for
by Clostridium human food. Diclazuril
perfringens as provided by No.
susceptible to 016592 in Sec.
virginiamycin; 510.600(c) of this
and for the chapter.
prevention of
coccidiosis
caused by Eimeria
tenella, E.
necatrix, E.
acervulina, E.
brunetti, E.
mitis (mivati),
and E. maxima.
Because
diclazuril is
effective against
E. maxima late in
its life cycle,
subclinical
intestinal
lesions may be
present for a
short time after
infection.
Diclazuril was
shown in studies
to reduce lesions
scores and
improve
performance and
health of birds
challenged with
E. maxima.
(v) 20......................... Lasalocid 68 to Broiler chickens: Feed continuously as 066104
113. For prevention of the sole ration. Do
necrotic not feed to laying
enteritis caused chickens. For broiler
by Clostridium or fryer chickens
perfringens only. Lasalocid as
susceptible to provided by No. 054771
virginiamycin; in Sec. 510.600(c)
and for the of this chapter.
prevention of
coccidiosis
caused by Eimeria
tenella, E.
necatrix, E.
acervulina, E.
brunetti, E.
mivati, and E.
maxima.
(vi) 20........................ Monensin 90 to 110 Broiler chickens: Feed continuously as 066104
For prevention of the sole ration. Do
necrotic not feed to laying
enteritis caused chickens. See Sec.
by Clostridium 558.355(d) in this
perfringens chapter. Monensin as
susceptible to provided by No. 058198
virginiamycin; in Sec. 510.600(c)
and as an aid in of this chapter.
the prevention of
coccidiosis
caused by Eimeria
necatrix, E.
tenella, E.
acervulina, E.
brunetti, E.
maxima, and E.
mivati.
(vii) 20....................... Salinomycin 40 to Broiler chickens: Feed continuously as ..............
60. For prevention of the sole ration. Do
necrotic not feed to chickens
enteritis caused over 16 weeks of age.
by Clostridium Do not feed to laying
perfringens chickens. Not approved
susceptible to for use with pellet
virginiamycin; binders. May be fatal
and for the if accidentally fed to
prevention of adult turkeys or
coccidiosis horses. Salinomycin as
caused by Eimeria provided by No. 016592
tenella, E. in Sec. 510.600(c)
necatrix, E. of this chapter.
acervulina, E.
maxima, E.
brunetti, and E.
mivati.
(viii) 20...................... Semduramicin 22.7. Broiler chickens: Feed continuously as 066104
For prevention of the sole ration. Do
necrotic not feed to laying
enteritis caused hens. Semduramicin as
by Clostridium provided by No. 066104
perfringens in Sec. 510.600(c)
susceptible to of this chapter.
virginiamycin;
and for the
prevention of
coccidiosis
caused by Eimeria
acervulina, E.
brunetti, E.
maxima, E mivati/
mitis, E.
necatrix, and E.
tenella.
(ix) 20........................ Semduramicin Broiler chickens: Feed continuously as 066104
(biomass) 22.7. For prevention of the sole ration.
necrotic Withdraw 1 day before
enteritis caused slaughter. Do not feed
by Clostridium to laying hens.
perfringens Semduramicin as
susceptible to provided by No. 066104
virginiamycin; in Sec. 510.600(c)
and for the of this chapter.
prevention of
coccidiosis
caused by Eimeria
acervulina, E.
brunetti, E.
maxima, E mivati/
mitis, E.
necatrix, and E.
tenella.
----------------------------------------------------------------------------------------------------------------
* * * * *
0
31. In Sec. 558.680, remove paragraph (e) and add paragraph (d)(3) to
read as follows:
Sec. 558.680 Zoalene.
* * * * *
(d) * * *
(3) Zoalene may also be used in combination with:
(i)-(ii) [Reserved]
(iii) Lincomycin as in Sec. 558.325.
[[Page 21694]]
Dated: May 4, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-09364 Filed 5-9-17; 8:45 am]
BILLING CODE 4164-01-P
