New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address, 67149-67153 [2016-23230]
Download as PDF
<![CDATA[
asabaliauskas on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations
a petition is classified, as identified by
documentation supplied to the
Commission and any supporting
information obtained by the
Commission.
(2) A determination of whether or not
domestic production of the article that
is the subject of the petition exists,
taking into account the report of the
Secretary of Commerce under section
3(c)(1) of the Act, and, if such
production exists, whether or not a
domestic producer of the article objects
to the duty suspension or reduction.
(3) Any technical changes to the
description of the article that is the
subject of the petition for the duty
suspension or reduction that are
necessary for purposes of administration
when the article is presented for
importation, taking into account the
report of the Secretary of Commerce
under section 3(c)(2) of the Act.
(4) An estimate of the amount of loss
in revenue to the United States that
would no longer be collected if the duty
suspension or reduction takes effect.
(5) A determination of whether or not
the duty suspension or reduction is
available to any person that imports the
article that is the subject of the duty
suspension or reduction.
(6) The likely beneficiaries of each
duty suspension or reduction, including
whether the petitioner is a likely
beneficiary.
(b) The preliminary report will also
include the following information:
(1) A list of petitions for duty
suspensions and reductions that meet
the requirements of the Act without
modifications.
(2) A list of petitions for duty
suspensions and reductions for which
the Commission recommends technical
corrections (i.e., corrections to the
article description that do not otherwise
substantially alter the scope or HTS
classification of the articles covered by
the petition) in order to meet the
requirements of the Act, with the
correction specified.
(3) A list of petitions for duty
suspensions and reductions for which
the Commission recommends
modifications to the amount of the duty
suspension or reduction that is the
subject of the petition to comply with
the requirements of the Act, with the
modification specified.
(4) A list of petitions for duty
suspensions and reductions for which
the Commission recommends
modifications to the scope of the articles
that are the subject of the petitions in
order to address objections by domestic
producers to such petitions, with the
modifications specified.
(5) A list of the following:
VerDate Sep<11>2014
18:28 Sep 29, 2016
Jkt 238001
(i) Petitions for duty suspensions and
reductions that the Commission has
determined do not contain the
information required under section
3(b)(2) of the Act.
(ii) Petitions for duty suspensions and
reductions with respect to which the
Commission has determined the
petitioner is not a likely beneficiary.
(6) A list of petitions for duty
suspensions and reductions that the
Commission does not recommend for
inclusion in a miscellaneous tariff bill,
other than petitions specified in section
3(b)(3)(C)(ii)(V) of the Act.
(c) The Commission will forward to
the Committees any additional
information submitted to the
Commission by the Secretary of
Commerce after the Commission
transmits its preliminary report.
§ 220.12
Commission final report.
(a) The Commission will submit its
final report on each petition for a duty
suspension or reduction specified in the
preliminary report to the Committees
not later than 60 days after the
Commission submits its preliminary
report. The final report will contain the
following information—
(1) The information required to be
included in a preliminary report under
section 3(b)(3)(C)(i)–(ii) of the Act and
updated as appropriate after considering
any information submitted by the
Committees under section 3(b)(3)(D) of
the Act.
(2) A determination of the
Commission whether—
(i) The duty suspension or reduction
can likely be administered by U.S.
Customs and Border Protection;
(ii) The estimated loss in revenue to
the United States from the duty
suspension or reduction does not
exceed $500,000 in a calendar year
during which the duty suspension or
reduction would be in effect; and
(iii) The duty suspension or reduction
is available to any person importing the
articles that is the subject of the duty
suspension or reduction.
(b) [Reserved]
§ 220.13 Confidential business
information.
PO 00000
Frm 00059
Fmt 4700
Sfmt 4700
(b) Exceptions. (1) In calculating the
estimated revenue loss required under
the Act, the Commission may base its
estimates in whole or in part on the
estimated values of imports submitted
by petitioners in their petitions.
(2) The Commission may disclose
some or all of the confidential business
information provided to the
Commission in petitions and public
comments to the U.S. Department of
Commerce for use in preparing its report
to the Commission and the Committees,
and to the U.S. Department of
Agriculture and CBP for use in
providing information for Commerce’s
report.
§ 220.14
rules.
Application of other Commission
Commission rules applicable to the
initiation and conduct of investigations,
including rules set out in subpart B of
part 201 of this chapter (except § 201.9
(methods employed in obtaining
information), § 201.14(a) (computation
of time), and § 201.15 (attorneys or
agents)), shall not apply to Commission
proceedings under this part.
By order of the Commission.
Issued: September 21, 2016.
Lisa R. Barton,
Secretary to the Commission.
[FR Doc. 2016–23229 Filed 9–29–16; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529,
and 558
[Docket No. FDA–2016–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Change of
Sponsor’s Address
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA, 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 July and
August 2016. FDA is also informing the
public of the availability of summaries
of the basis of approval and of
environmental review documents,
where applicable. The animal drug
regulations are also being amended to
reflect a change of a sponsor’s address.
SUMMARY:
(a) In general. The Commission will
not release information which the
Commission considers to be
confidential business information
within the meaning of § 201.6(a) of this
chapter unless the party submitting the
confidential business information had
notice, at the time of submission, that
such information would be released by
the Commission, or such party
subsequently consents to the release of
the information.
67149
E:\FR\FM\30SER1.SGM
30SER1
67150
Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations
This rule is effective September
30, 2016.
and August 2016, 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
DATES:
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Approval Actions
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs and ANADAs during July
a.m. and 4 p.m., Monday through
Friday. Persons with access to the
Internet may obtain these documents at
the CVM FOIA Electronic Reading
Room: https://www.fda.gov/AboutFDA/
CentersOffices/OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm. Marketing exclusivity and
patent information may be accessed in
FDA’s publication, Approved Animal
Drug Products Online (Green Book) at:
https://www.fda.gov/AnimalVeterinary/
Products/ApprovedAnimalDrug
Products/default.htm.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY AND AUGUST 2016
Approval date
Sponsor
File No.
Product name
Species
Effect of the action/
indications for use
Original approval for
the control of pain
and inflammation
associated with
osteoarthritis in
horses.
Original approval for
killing adult fleas,
for the treatment
and prevention of
flea infestations,
and for the treatment and control
of tick infestations
in dogs and cats.
Original approval to
provide local postoperative analgesia for cranial
cruciate ligament
surgery in dogs.
Original approval of
a generic copy of
NADA 111–607.
FOI Summary.
Original approval of
a generic copy of
NADA 012–965.
FOI Summary.
July 24, 2016 ..................
141–458
Merial, Inc., 3239
Satellite Blvd.,
bldg. 500, Duluth,
GA 30096–4640.
EQUIOXX (firocoxib)
Tablets.
Horses ..............
July 20, 2016 ..................
141–459
Intervet, Inc., 2
Giralda Farms,
Madison, NJ
07940.
BRAVECTO
(fluralaner topical
solution) for Dogs.
BRAVECTO
(fluralaner topical
solution) for Cats.
Dogs, cats ........
August 12, 2016 .............
141–461
NOCITA
(bupivacaine
liposome
injectable suspension).
Dogs .................
July 1, 2016 ....................
200–501
Praziquantel
(praziquantel) Injection.
Dogs .................
August 5, 2016 ...............
200–508
Aratana Therapeutics, Inc.,
11400 Tomahawk
Creek Pkwy.,
Leawood, KS
66211.
Cross Vetpharm
Group Ltd.
Broomhill Rd.,
Tallaght, Dublin
24, Ireland.
Cross Vetpharm
Group Ltd.
Broomhill Rd.,
Tallaght, Dublin
24, Ireland.
BILOVET (tylosin)
Injection.
Cattle, swine .....
asabaliauskas on DSK3SPTVN1PROD with RULES
II. Change of Sponsor’s Address
Nexcyon Pharmaceuticals, Inc., 644
West Washington Ave., Madison, WI
53719 has informed FDA that it has
changed its address to P.O. Box 259158,
Madison, WI 53725. Accordingly, the
regulations at 21 CFR 510.600(c) will be
amended to reflect this sponsor’s change
of address.
III. Technical Amendments
FDA has noticed that drug labeler
codes (DLCs) in several sections of part
558 (21 CFR part 558) do not accurately
reflect the sponsorship of a new animal
drug application. At this time, we are
amending part 558 to remove these
VerDate Sep<11>2014
18:28 Sep 29, 2016
Jkt 238001
DLCs. Also, FDA is amending the
regulations to revise a human food
safety warning for tulathromycin
injectable solution in 21 CFR 522.2630
and to correct a cross-reference for
combination medicated feeds in
§ 558.128 (21 CFR 558.128). These
actions are being taken to improve the
accuracy of the regulations.
The restrictions for veterinary feed
directive (VFD) drugs in part 558 are
being revised to reflect a uniform text.
In addition, we are revising § 558.59 to
reflect a current format. These actions
are being taken to improve the clarity of
the regulations.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
PO 00000
Frm 00060
Fmt 4700
Sfmt 4700
Public
documents
FOI Summary.
FOI Summary.
FOI Summary.
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
List of Subjects
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
E:\FR\FM\30SER1.SGM
30SER1
Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR parts 510, 520, 522, 524, 529, and
558 are amended as follows:
PART 510—NEW ANIMAL DRUGS
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.
§ 510.600
[Amended]
§ 520.2345c
2. Revise § 510.600 as follows:
a. In the table in paragraph (c)(1):
i. In the entries for ‘‘Cronus Pharma
LLC’’, ‘‘HQ Specialty Pharma Corp.’’,
‘‘OXIS International, Inc.’’, ‘‘Pharmgate
LLC ‘‘, ‘‘Putney, Inc.’’, ‘‘SmartVet USA,
Inc.’’, and ‘‘Wildlife Laboratories, Inc.’’,
remove ‘‘Suite’’ and in its place add
‘‘suite’’;
■ ii. In the entry for ‘‘Merial, Inc.’’,
remove ‘‘Bldg.’’ and in its place add
‘‘bldg.’’;
■ iii. In the entry for ‘‘Nexcyon
Pharmaceuticals, Inc.’’, remove ‘‘644
West Washington Ave., Madison, WI
53719’’ and in its place add ‘‘P.O. Box
259158, Madison, WI 53725’’;
■ b. In the table in paragraph (c)(2):
■ i. In the entries for ‘‘024991’’,
‘‘026637’’, ‘‘042791’’, ‘‘053923’’,
‘‘069043’’, ‘‘069254’’, and ‘‘086001’’,
remove ‘‘Suite’’ and in its place add
‘‘suite’’;
■ ii. In the entry for ‘‘050604’’, remove
‘‘Bldg.’’ and in its place add ‘‘bldg.’’;
and
■ iii. In the entry for ‘‘050929’’, remove
‘‘644 West Washington Ave., Madison,
WI 53719’’ and in its place add ‘‘P.O.
Box 259158, Madison, WI 53725’’.
■
■
■
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for part 520
continues to read as follows:
■
4. In § 520.928, revise paragraph (c) to
read as follows:
■
Firocoxib tablets.
asabaliauskas on DSK3SPTVN1PROD with RULES
*
*
*
*
*
(c) Conditions of use—(1) Dogs—(i)
Amount. 5 mg/kg (2.27 mg/lb) body
weight. Administer once daily for
osteoarthritis. Administer
approximately 2 hours before soft tissue
or orthopedic surgery.
(ii) Indications for use. For the control
of pain and inflammation associated
with osteoarthritis; and for the control
of postoperative pain and inflammation
associated with soft-tissue and
orthopedic surgery.
VerDate Sep<11>2014
18:28 Sep 29, 2016
Jkt 238001
[Amended]
5. In § 520.2345c, remove paragraph
(d)(1)(iii).
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
6. The authority citation for part 522
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
7. Add § 522.224 to read as follows:
§ 522.224
Bupivacaine.
(a) Specifications. Each milliliter (mL)
of liposomal suspension contains 13.3
milligrams (mg) bupivacaine.
(b) Sponsor. See No. 086026 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer 5.3 mg/kg (0.4 mL/
kg) by infiltration injection into the
tissue layers at the time of incisional
closure.
(2) Indications for use. For single-dose
infiltration into the surgical site to
provide local postoperative analgesia for
cranial cruciate ligament surgery in
dogs.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 8. In § 522.1870, revise paragraphs (a),
(c)(1)(i) and (iii), and (c)(2)(i) and (iii) to
read as follows:
Praziquantel.
(a) Specifications. Each milliliter (mL)
of solution contains 56.8 milligrams of
praziquantel.
*
*
*
*
*
(c) * * *
(1) * * *
(i) Amount. Administer by
subcutaneous or intramuscular injection
for dogs and puppies 5 pounds (lb) and
under, 0.3 mL; for 6 to 10 lb, 0.5 mL;
for 11 to 25 lb, 1.0 mL; if over 25 lb, 0.2
mL/5 lb body weight to a maximum of
3 mL.
*
*
*
*
*
(iii) Limitations. Federal law restricts
the drug to use by or on the order of a
licensed veterinarian.
PO 00000
Frm 00061
Fmt 4700
Sfmt 4700
(2) * * *
(i) Amount. Administer by
subcutaneous or intramuscular injection
for cats and kittens under 5 lb, 0.2 mL;
5 to 10 lb, 0.4 mL; 11 lb and over, 0.6
mL maximum.
*
*
*
*
*
(iii) Limitations. Federal law restricts
the drug to use by or on the order of a
licensed veterinarian.
■ 9. In § 522.2630, revise paragraph
(d)(1)(iii)(A) to read as follows:
§ 522.2630
Tulathromycin.
*
■
§ 522.1870
Authority: 21 U.S.C. 360b
§ 520.928
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) Horses—(i) Amount. Administer
one 57-mg tablet to horses weighing 800
to 1,300 lb once daily for up to 14 days.
(ii) Indications for use. For the control
of pain and inflammation associated
with osteoarthritis.
(iii) Limitations. Do not use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
67151
*
*
*
*
(d) * * *
(1) * * *
(iii) * * *
(A) Cattle intended for human
consumption must not be slaughtered
within 18 days from the last treatment.
This drug is not approved for use in
female dairy cattle 20 months of age or
older, including dry dairy cows. Use in
these cattle may cause drug residues in
milk and/or in calves born to these
cows. Federal law restricts this drug to
use by or on the order of a licensed
veterinarian.
*
*
*
*
*
■ 10. Revise § 522.2640 to read as
follows:
§ 522.2640
Tylosin.
(a) Specifications. Each milliliter (mL)
of solution contains 50 or 200
milligrams (mg) of tylosin activity (as
tylosin base).
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter as follows:
(1) No. 000986 for use of 50- or 200mg/mL solutions as in paragraph (e) of
this section.
(2) Nos. 000010 and 061623 for use of
a 200-mg/mL solution as in paragraphs
(e)(1) and (2) of this section.
(c) Related tolerances. See § 556.740
of this chapter.
(d) Special considerations. Labeling
must bear the warning statements: ‘‘Do
not administer to horses or other
equines. Injection of tylosin in equines
has been fatal.’’
(e) Conditions of use—(1) Beef cattle
and nonlactating dairy cattle—(i)
Amount. Administer 8 mg per pound
(mg/lb) of body weight by intramuscular
injection once daily for not more than
5 consecutive days. Continue treatment
24 hours after symptoms disappear.
(ii) Indications for use. Treatment of
bovine respiratory complex (shipping
fever, pneumonia) usually associated
with Pasteurella multocida and
Arcanobacterium pyogenes; foot rot
(necrotic pododermatitis) and calf
diphtheria caused by Fusobacterium
necrophorum and metritis caused by A.
pyogenes.
E:\FR\FM\30SER1.SGM
30SER1
asabaliauskas on DSK3SPTVN1PROD with RULES
67152
Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations
(iii) Limitations. Do not inject more
than 10 mL per site. Use a 50-mg/mL
solution for calves weighing less than
200 pounds. Cattle intended for human
consumption must not be slaughtered
within 21 days of the last use of this
drug product. This drug product is not
approved for use in female dairy cattle
20 months of age or older, including dry
dairy cows. Use in these cattle may
cause drug residues in milk and/or in
calves born to these cows. This product
is not approved for use in calves
intended to be processed for veal. A
withdrawal period has not been
established in preruminating calves.
(2) Swine—(i) Amount. Administer 4
mg/lb of body weight by intramuscular
injection twice daily for not more than
3 consecutive days. Continue treatment
24 hours after symptoms disappear. If
tylosin medicated drinking water is
used as a followup treatment for swine
dysentery, the animal should thereafter
receive feed containing 40 to 100 grams
of tylosin per ton for 2 weeks to assure
depletion of tissue residues.
(ii) Indications for use. Treatment of
swine arthritis caused by Mycoplasma
hyosynoviae; swine pneumonia caused
by Pasteurella spp.; swine erysipelas
caused by Erysipelothrix rhusiopathiae;
swine dysentery associated with
Treponema hyodysenteriae when
followed by appropriate medication in
the drinking water and/or feed.
(iii) Limitations. Do not inject more
than 5 mL per site. Adverse reactions,
including shock and death may result
from overdosage in baby pigs. It is
recommended that tylosin 50-mg/mL
injection be used in pigs weighing less
than 25 lbs. Swine intended for human
consumption must not be slaughtered
within 14 days of the last use of this
drug product.
(3) Dogs and cats—(i) Amount.
Administer 3 to 5 mg/lb of body weight
by intramuscular injection at 12- to 24hour intervals.
(ii) Indications for use—(A) Dogs.
Treatment of upper respiratory
infections such as bronchitis,
tracheobronchitis, tracheitis, laryngitis,
tonsillitis, and pneumonia caused by
Staphylococci spp., hemolytic
Streptococci spp., and Pasteurella
multocida.
(B) Cats. Treatment of upper
respiratory infections when caused by
Staphylococci spp. and hemolytic
Streptococci spp. and for feline
pneumonitis when caused by tylosinsusceptible organisms.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
VerDate Sep<11>2014
18:28 Sep 29, 2016
Jkt 238001
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
11. The authority citation for part 524
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
12. Add § 524.998 to read as follows:
§ 524.998
Fluralaner.
(a) Specifications. Each milliliter of
solution contains 280 milligrams (mg)
fluralaner.
(b) Sponsor. See No. 000061 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Dogs—(i)
Amount. Administer topically as a
single dose every 12 weeks according to
the label dosage schedule to provide a
minimum dose of 11.4 mg/lb (25 mg/kg)
body weight. May be administered every
8 weeks in case of potential exposure to
Amblyomma americanum ticks.
(ii) Indications for use. Kills adult
fleas; for the treatment and prevention
of flea infestations (Ctenocephalides
felis) and the treatment and control of
tick infestations (Ixodes scapularis
(black-legged tick), Dermacentor
variabilis (American dog tick), and
Rhipicephalus sanguineus (brown dog
tick)) for 12 weeks in dogs and puppies
6 months of age and older, and weighing
4.4 lb or greater; for the treatment and
control of A. americanum (lone star
tick) infestations for 8 weeks in dogs
and puppies 6 months of age and older,
and weighing 4.4 lb or greater.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) [Reserved]
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
13. The authority citation for part 529
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 529.400
[Amended]
14. In § 529.400, in paragraph (a),
remove footnote 1.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
15. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
[Amended]
16. In § 558.58, in paragraph (e)(6),
remove ‘‘3.6’’ and in its place add
‘‘36.6’’.
■ 17. Revise § 558.59 to read as follows:
■
PO 00000
Frm 00062
Fmt 4700
Sfmt 4700
Apramycin.
(a) Specifications. Each pound of
Type A article contains 75 grams
apramycin (as apramycin sulfate).
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
(c) [Reserved]
(d) Related tolerances. See § 556.52 of
this chapter.
(e) Conditions of use in swine—(1)
Amount. Feed at 150 grams apramycin
per ton of Type C medicated feed as the
sole ration for 14 consecutive days.
(2) Indications for use. For control of
porcine colibacillosis (weanling pig
scours) caused by susceptible strains of
Escherichia coli.
(3) Limitations. Withdraw 28 days
before slaughter.
§ 558.68
[Amended]
18. In § 558.68, redesignate
paragraphs (c) and (d) as paragraphs (d)
and (c); and in paragraphs (e)(1)(i) and
(e)(2)(i), remove ‘‘000986’’ and in its
place add ‘‘058198’’.
■
§ 558.128
[Amended]
19. In § 558.128, in paragraph
(e)(7)(xi), remove ‘‘§ 558.600’’ and in its
place add ″§ 558.612″.
■
§ 558.195
[Amended]
20. In § 558.195, in paragraph
(e)(1)(vi), remove ‘‘000009’’ and in its
place add ‘‘054771’’; and in paragraphs
(e)(2)(iii) and (v), remove ‘‘000986’’
wherever it appears and in its place add
‘‘058198’’.
■
§ 558.261
[Amended]
21. In § 558.261, redesignate
paragraphs (c) and (d) as paragraphs (d)
and (c).
■
§ 558.295
[Amended]
22. In § 558.295, remove and reserve
paragraph (b).
■ 23. In § 558.325, revise paragraph
(d)(3) to read as follows:
■
§ 558.325
Lincomycin.
*
■
§ 558.58
§ 558.59
*
*
*
*
(d) * * *
(3) Labeling of Type A medicated
articles and single-ingredient Type B
and Type C medicated feeds containing
lincomycin intended for use in swine
shall bear the following caution
statement: ‘‘The effects of lincomycin on
swine reproductive performance,
pregnancy, and lactation have not been
determined. Not for use in swine
intended for breeding when lincomycin
is fed at 20 grams per ton of complete
feed.’’
*
*
*
*
*
§ 558.342
[Amended]
24. In § 558.342, in paragraphs
(e)(1)(iv),(ix), (x), and (xi), remove
■
E:\FR\FM\30SER1.SGM
30SER1
Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations
‘‘000986’’ wherever it appears and in its
place add ‘‘058198’’.
§ 558.366
[Amended]
25. In § 558.366, in paragraph (d), in
the entry for ‘‘113.5 (0.0125 pct)’’,
remove ‘‘000986’’ and in its place add
‘‘058198’’.
■
§ 558.618
[Amended]
26. In § 558.618, redesignate
paragraphs (c) and (d) as paragraphs (d)
and (c).
■ 27. In § 558.633, revise paragraph
(d)(1) to read as follows:
■
§ 558.633
Tylvalocin.
*
*
*
*
*
(d) * * *
(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.
*
*
*
*
*
Dated: September 21, 2016.
Tracey Forfa,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. 2016–23230 Filed 9–29–16; 8:45 am]
BILLING CODE 4164–01–P
Electronic Submissions
Submit electronic objections in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Objections submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
objection will be made public, you are
solely responsible for ensuring that your
objection does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
objection, that information will be
posted on https://www.regulations.gov.
• If you want to submit an objection
with confidential information that you
do not wish to be made available to the
public, submit the objection as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA–2014–F–0988]
Food Additives Permitted in Feed and
Drinking Water of Animals; Feed Grade
Sodium Formate
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA, we, the Agency)
is amending the regulations for food
additives permitted in feed and drinking
water of animals to provide for the safe
use of feed grade sodium formate as a
feed acidifying agent in complete swine
feeds. This action is in response to a
food additive petition filed by BASF
Corp.
asabaliauskas on DSK3SPTVN1PROD with RULES
SUMMARY:
This rule is effective September
30, 2016. Submit either electronic or
written objections and requests for a
hearing by October 31, 2016. See section
V of this document for further
information on the filing of objections.
ADDRESSES: You may submit objections
and requests for a hearing as follows:
DATES:
VerDate Sep<11>2014
18:28 Sep 29, 2016
Jkt 238001
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper objections
submitted to the Division of Dockets
Management, FDA will post your
objection, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2014–F–0988 for ‘‘Food Additives
Permitted in Feed and Drinking Water
of Animals; Feed Grade Sodium
Formate.’’ Received objections will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit an objection with confidential
information that you do not wish to be
made publicly available, submit your
objections only as a written/paper
submission. You should submit two
copies total. One copy will include the
PO 00000
Frm 00063
Fmt 4700
Sfmt 4700
67153
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
objections and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper objections
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Chelsea Trull, Center for Veterinary
Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–6729,
chelsea.trull@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In a document published in the
Federal Register of July 25, 2014 (79 FR
43325), FDA announced that we had
filed a food additive petition (animal
use) (FAP 2286) submitted by BASF
Corp., 100 Park Ave., Florham Park, NJ
07932. The petition proposed that the
regulations for food additives permitted
in feed and drinking water of animals be
amended to provide for the safe use of
feed grade sodium formate as a feed
acidifying agent in complete swine
feeds. The notice of petition provided
for a 30-day comment period on the
petitioner’s request for categorical
exclusion from preparing an
environmental assessment or
environmental impact statement.
E:\FR\FM\30SER1.SGM
30SER1
]]>Agencies
[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Rules and Regulations]
[Pages 67149-67153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23230]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529, and 558
[Docket No. FDA-2016-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Change of Sponsor's Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, 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 July and August 2016. FDA is also
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable. The
animal drug regulations are also being amended to reflect a change of a
sponsor's address.
[[Page 67150]]
DATES: This rule is effective September 30, 2016.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-402-5689,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Approval Actions
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during July and August 2016, 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 July and August 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effect of the
Approval date File No. Sponsor Product name Species action/indications Public documents
for use
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 24, 2016.................. 141-458 Merial, Inc., 3239 EQUIOXX Horses................. Original approval FOI Summary.
Satellite Blvd., (firocoxib) for the control
bldg. 500, Tablets. of pain and
Duluth, GA 30096- inflammation
4640. associated with
osteoarthritis in
horses.
July 20, 2016.................. 141-459 Intervet, Inc., 2 BRAVECTO Dogs, cats............. Original approval FOI Summary.
Giralda Farms, (fluralaner for killing adult
Madison, NJ 07940. topical solution) fleas, for the
for Dogs. treatment and
BRAVECTO prevention of
(fluralaner flea
topical solution) infestations, and
for Cats. for the treatment
and control of
tick infestations
in dogs and cats.
August 12, 2016................ 141-461 Aratana NOCITA Dogs................... Original approval FOI Summary.
Therapeutics, (bupivacaine to provide local
Inc., 11400 liposome postoperative
Tomahawk Creek injectable analgesia for
Pkwy., Leawood, suspension). cranial cruciate
KS 66211. ligament surgery
in dogs.
July 1, 2016................... 200-501 Cross Vetpharm Praziquantel Dogs................... Original approval FOI Summary.
Group Ltd. (praziquantel) of a generic copy
Broomhill Rd., Injection. of NADA 111-607.
Tallaght, Dublin
24, Ireland.
August 5, 2016................. 200-508 Cross Vetpharm BILOVET (tylosin) Cattle, swine.......... Original approval FOI Summary.
Group Ltd. Injection. of a generic copy
Broomhill Rd., of NADA 012-965.
Tallaght, Dublin
24, Ireland.
--------------------------------------------------------------------------------------------------------------------------------------------------------
II. Change of Sponsor's Address
Nexcyon Pharmaceuticals, Inc., 644 West Washington Ave., Madison,
WI 53719 has informed FDA that it has changed its address to P.O. Box
259158, Madison, WI 53725. Accordingly, the regulations at 21 CFR
510.600(c) will be amended to reflect this sponsor's change of address.
III. Technical Amendments
FDA has noticed that drug labeler codes (DLCs) in several sections
of part 558 (21 CFR part 558) do not accurately reflect the sponsorship
of a new animal drug application. At this time, we are amending part
558 to remove these DLCs. Also, FDA is amending the regulations to
revise a human food safety warning for tulathromycin injectable
solution in 21 CFR 522.2630 and to correct a cross-reference for
combination medicated feeds in Sec. 558.128 (21 CFR 558.128). These
actions are being taken to improve the accuracy of the regulations.
The restrictions for veterinary feed directive (VFD) drugs in part
558 are being revised to reflect a uniform text. In addition, we are
revising Sec. 558.59 to reflect a current format. These actions are
being taken to improve the clarity of the regulations.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
[[Page 67151]]
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
520, 522, 524, 529, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 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. Revise Sec. 510.600 as follows:
0
a. In the table in paragraph (c)(1):
0
i. In the entries for ``Cronus Pharma LLC'', ``HQ Specialty Pharma
Corp.'', ``OXIS International, Inc.'', ``Pharmgate LLC ``, ``Putney,
Inc.'', ``SmartVet USA, Inc.'', and ``Wildlife Laboratories, Inc.'',
remove ``Suite'' and in its place add ``suite'';
0
ii. In the entry for ``Merial, Inc.'', remove ``Bldg.'' and in its
place add ``bldg.'';
0
iii. In the entry for ``Nexcyon Pharmaceuticals, Inc.'', remove ``644
West Washington Ave., Madison, WI 53719'' and in its place add ``P.O.
Box 259158, Madison, WI 53725'';
0
b. In the table in paragraph (c)(2):
0
i. In the entries for ``024991'', ``026637'', ``042791'', ``053923'',
``069043'', ``069254'', and ``086001'', remove ``Suite'' and in its
place add ``suite'';
0
ii. In the entry for ``050604'', remove ``Bldg.'' and in its place add
``bldg.''; and
0
iii. In the entry for ``050929'', remove ``644 West Washington Ave.,
Madison, WI 53719'' and in its place add ``P.O. Box 259158, Madison, WI
53725''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b
0
4. In Sec. 520.928, revise paragraph (c) to read as follows:
Sec. 520.928 Firocoxib tablets.
* * * * *
(c) Conditions of use--(1) Dogs--(i) Amount. 5 mg/kg (2.27 mg/lb)
body weight. Administer once daily for osteoarthritis. Administer
approximately 2 hours before soft tissue or orthopedic surgery.
(ii) Indications for use. For the control of pain and inflammation
associated with osteoarthritis; and for the control of postoperative
pain and inflammation associated with soft-tissue and orthopedic
surgery.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Horses--(i) Amount. Administer one 57-mg tablet to horses
weighing 800 to 1,300 lb once daily for up to 14 days.
(ii) Indications for use. For the control of pain and inflammation
associated with osteoarthritis.
(iii) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
Sec. 520.2345c [Amended]
0
5. In Sec. 520.2345c, remove paragraph (d)(1)(iii).
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
6. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
7. Add Sec. 522.224 to read as follows:
Sec. 522.224 Bupivacaine.
(a) Specifications. Each milliliter (mL) of liposomal suspension
contains 13.3 milligrams (mg) bupivacaine.
(b) Sponsor. See No. 086026 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer 5.3 mg/kg
(0.4 mL/kg) by infiltration injection into the tissue layers at the
time of incisional closure.
(2) Indications for use. For single-dose infiltration into the
surgical site to provide local postoperative analgesia for cranial
cruciate ligament surgery in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
8. In Sec. 522.1870, revise paragraphs (a), (c)(1)(i) and (iii), and
(c)(2)(i) and (iii) to read as follows:
Sec. 522.1870 Praziquantel.
(a) Specifications. Each milliliter (mL) of solution contains 56.8
milligrams of praziquantel.
* * * * *
(c) * * *
(1) * * *
(i) Amount. Administer by subcutaneous or intramuscular injection
for dogs and puppies 5 pounds (lb) and under, 0.3 mL; for 6 to 10 lb,
0.5 mL; for 11 to 25 lb, 1.0 mL; if over 25 lb, 0.2 mL/5 lb body weight
to a maximum of 3 mL.
* * * * *
(iii) Limitations. Federal law restricts the drug to use by or on
the order of a licensed veterinarian.
(2) * * *
(i) Amount. Administer by subcutaneous or intramuscular injection
for cats and kittens under 5 lb, 0.2 mL; 5 to 10 lb, 0.4 mL; 11 lb and
over, 0.6 mL maximum.
* * * * *
(iii) Limitations. Federal law restricts the drug to use by or on
the order of a licensed veterinarian.
0
9. In Sec. 522.2630, revise paragraph (d)(1)(iii)(A) to read as
follows:
Sec. 522.2630 Tulathromycin.
* * * * *
(d) * * *
(1) * * *
(iii) * * *
(A) Cattle intended for human consumption must not be slaughtered
within 18 days from the last treatment. This drug is not approved for
use in female dairy cattle 20 months of age or older, including dry
dairy cows. Use in these cattle may cause drug residues in milk and/or
in calves born to these cows. Federal law restricts this drug to use by
or on the order of a licensed veterinarian.
* * * * *
0
10. Revise Sec. 522.2640 to read as follows:
Sec. 522.2640 Tylosin.
(a) Specifications. Each milliliter (mL) of solution contains 50 or
200 milligrams (mg) of tylosin activity (as tylosin base).
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as
follows:
(1) No. 000986 for use of 50- or 200-mg/mL solutions as in
paragraph (e) of this section.
(2) Nos. 000010 and 061623 for use of a 200-mg/mL solution as in
paragraphs (e)(1) and (2) of this section.
(c) Related tolerances. See Sec. 556.740 of this chapter.
(d) Special considerations. Labeling must bear the warning
statements: ``Do not administer to horses or other equines. Injection
of tylosin in equines has been fatal.''
(e) Conditions of use--(1) Beef cattle and nonlactating dairy
cattle--(i) Amount. Administer 8 mg per pound (mg/lb) of body weight by
intramuscular injection once daily for not more than 5 consecutive
days. Continue treatment 24 hours after symptoms disappear.
(ii) Indications for use. Treatment of bovine respiratory complex
(shipping fever, pneumonia) usually associated with Pasteurella
multocida and Arcanobacterium pyogenes; foot rot (necrotic
pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum
and metritis caused by A. pyogenes.
[[Page 67152]]
(iii) Limitations. Do not inject more than 10 mL per site. Use a
50-mg/mL solution for calves weighing less than 200 pounds. Cattle
intended for human consumption must not be slaughtered within 21 days
of the last use of this drug product. This drug product is not approved
for use in female dairy cattle 20 months of age or older, including dry
dairy cows. Use in these cattle may cause drug residues in milk and/or
in calves born to these cows. This product is not approved for use in
calves intended to be processed for veal. A withdrawal period has not
been established in preruminating calves.
(2) Swine--(i) Amount. Administer 4 mg/lb of body weight by
intramuscular injection twice daily for not more than 3 consecutive
days. Continue treatment 24 hours after symptoms disappear. If tylosin
medicated drinking water is used as a followup treatment for swine
dysentery, the animal should thereafter receive feed containing 40 to
100 grams of tylosin per ton for 2 weeks to assure depletion of tissue
residues.
(ii) Indications for use. Treatment of swine arthritis caused by
Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp.;
swine erysipelas caused by Erysipelothrix rhusiopathiae; swine
dysentery associated with Treponema hyodysenteriae when followed by
appropriate medication in the drinking water and/or feed.
(iii) Limitations. Do not inject more than 5 mL per site. Adverse
reactions, including shock and death may result from overdosage in baby
pigs. It is recommended that tylosin 50-mg/mL injection be used in pigs
weighing less than 25 lbs. Swine intended for human consumption must
not be slaughtered within 14 days of the last use of this drug product.
(3) Dogs and cats--(i) Amount. Administer 3 to 5 mg/lb of body
weight by intramuscular injection at 12- to 24-hour intervals.
(ii) Indications for use--(A) Dogs. Treatment of upper respiratory
infections such as bronchitis, tracheobronchitis, tracheitis,
laryngitis, tonsillitis, and pneumonia caused by Staphylococci spp.,
hemolytic Streptococci spp., and Pasteurella multocida.
(B) Cats. Treatment of upper respiratory infections when caused by
Staphylococci spp. and hemolytic Streptococci spp. and for feline
pneumonitis when caused by tylosin-susceptible organisms.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
11. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
12. Add Sec. 524.998 to read as follows:
Sec. 524.998 Fluralaner.
(a) Specifications. Each milliliter of solution contains 280
milligrams (mg) fluralaner.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Dogs--(i) Amount. Administer topically
as a single dose every 12 weeks according to the label dosage schedule
to provide a minimum dose of 11.4 mg/lb (25 mg/kg) body weight. May be
administered every 8 weeks in case of potential exposure to Amblyomma
americanum ticks.
(ii) Indications for use. Kills adult fleas; for the treatment and
prevention of flea infestations (Ctenocephalides felis) and the
treatment and control of tick infestations (Ixodes scapularis (black-
legged tick), Dermacentor variabilis (American dog tick), and
Rhipicephalus sanguineus (brown dog tick)) for 12 weeks in dogs and
puppies 6 months of age and older, and weighing 4.4 lb or greater; for
the treatment and control of A. americanum (lone star tick)
infestations for 8 weeks in dogs and puppies 6 months of age and older,
and weighing 4.4 lb or greater.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) [Reserved]
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
13. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 529.400 [Amended]
0
14. In Sec. 529.400, in paragraph (a), remove footnote 1.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
15. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
Sec. 558.58 [Amended]
0
16. In Sec. 558.58, in paragraph (e)(6), remove ``3.6'' and in its
place add ``36.6''.
0
17. Revise Sec. 558.59 to read as follows:
Sec. 558.59 Apramycin.
(a) Specifications. Each pound of Type A article contains 75 grams
apramycin (as apramycin sulfate).
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) [Reserved]
(d) Related tolerances. See Sec. 556.52 of this chapter.
(e) Conditions of use in swine--(1) Amount. Feed at 150 grams
apramycin per ton of Type C medicated feed as the sole ration for 14
consecutive days.
(2) Indications for use. For control of porcine colibacillosis
(weanling pig scours) caused by susceptible strains of Escherichia
coli.
(3) Limitations. Withdraw 28 days before slaughter.
Sec. 558.68 [Amended]
0
18. In Sec. 558.68, redesignate paragraphs (c) and (d) as paragraphs
(d) and (c); and in paragraphs (e)(1)(i) and (e)(2)(i), remove
``000986'' and in its place add ``058198''.
Sec. 558.128 [Amended]
0
19. In Sec. 558.128, in paragraph (e)(7)(xi), remove ``Sec. 558.600''
and in its place add ''Sec. 558.612''.
Sec. 558.195 [Amended]
0
20. In Sec. 558.195, in paragraph (e)(1)(vi), remove ``000009'' and in
its place add ``054771''; and in paragraphs (e)(2)(iii) and (v), remove
``000986'' wherever it appears and in its place add ``058198''.
Sec. 558.261 [Amended]
0
21. In Sec. 558.261, redesignate paragraphs (c) and (d) as paragraphs
(d) and (c).
Sec. 558.295 [Amended]
0
22. In Sec. 558.295, remove and reserve paragraph (b).
0
23. In Sec. 558.325, revise paragraph (d)(3) to read as follows:
Sec. 558.325 Lincomycin.
* * * * *
(d) * * *
(3) Labeling of Type A medicated articles and single-ingredient
Type B and Type C medicated feeds containing lincomycin intended for
use in swine shall bear the following caution statement: ``The effects
of lincomycin on swine reproductive performance, pregnancy, and
lactation have not been determined. Not for use in swine intended for
breeding when lincomycin is fed at 20 grams per ton of complete feed.''
* * * * *
Sec. 558.342 [Amended]
0
24. In Sec. 558.342, in paragraphs (e)(1)(iv),(ix), (x), and (xi),
remove
[[Page 67153]]
``000986'' wherever it appears and in its place add ``058198''.
Sec. 558.366 [Amended]
0
25. In Sec. 558.366, in paragraph (d), in the entry for ``113.5
(0.0125 pct)'', remove ``000986'' and in its place add ``058198''.
Sec. 558.618 [Amended]
0
26. In Sec. 558.618, redesignate paragraphs (c) and (d) as paragraphs
(d) and (c).
0
27. In Sec. 558.633, revise paragraph (d)(1) to read as follows:
Sec. 558.633 Tylvalocin.
* * * * *
(d) * * *
(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.
* * * * *
Dated: September 21, 2016.
Tracey Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-23230 Filed 9-29-16; 8:45 am]
BILLING CODE 4164-01-P
