[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)]
[Rules and Regulations]
[Pages 43482-43485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19602]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and 558
[Docket No. FDA-2017-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 amendments.
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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for a
new animal drug application (NADA) and abbreviated new animal drug
applications (ANADAs) during March and April 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 a change of a
sponsor's address and to make technical amendments to improve the
accuracy of the regulations.
DATES: This rule is effective September 18, 2017.
[[Page 43483]]
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-5689,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Approval Actions
FDA is amending the animal drug regulations to reflect approval
actions for a NADA and ANADAs during March and April 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 Dockets Management
Staff Office (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 March and April 2017
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Approval date File No. Sponsor Product name Species Effect of the action Public documents
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April 24, 2017................ 141-269 Intervet, Inc., REVALOR-XH Cattle........ Supplemental approval FOI Summary, EA/FONSI.\1\
2 Giralda (trenbolone of a new implant for
Farms, Madison, acetate and increased rate of
NJ 07940. estradiol weight gain and
extended- improved feed
release efficiency for up to
implant). 200 days after
implantation in beef
heifers fed in
confinement for
slaughter.
April 19, 2017................ 200-593 Accord Carprofen Dogs.......... Original approval as FOI Summary.
Healthcare, Injection. a generic copy of
Inc., 1009 NADA 141-199.
Slater Rd.,
Suite 210-B,
Durham, NC
27703.
April 28, 2017................ 200-595 Norbrook CARPRIEVE Dogs.......... Original approval as FOI Summary.
Laboratories, (carprofen) a generic copy of
Ltd., Station Chewable NADA 141-111.
Works, Newry Tablets.
BT35 6JP,
Northern
Ireland.
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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).
II. Technical Amendments
Pharmgate LLC, 1015 Ashes Dr., suite 102, Wilmington, NC 28405, has
informed FDA that it has changed its address to 1800 Sir Tyler Dr.,
Wilmington, NC 28405. Accordingly, we are amending Sec. 510.600(c) to
reflect this change.
We are 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. We are also making several technical
amendments to the regulations for dosage form drugs. These actions are
being taken to improve the accuracy of the regulations.
III. Legal Authority
This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C 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 FD&C 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.''
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:
[[Page 43484]]
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), revise the entry
for ``Pharmgate LLC''; and in the table in paragraph (c)(2), revise the
entry for ``069254'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug
Firm name and address labeler
code
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* * * * *
Pharmgate LLC, 1800 Sir Tyler Dr., Wilmington, NC 28405..... 069254
* * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * *
069254........................... Pharmgate LLC, 1800 Sir Tyler Dr.,
Wilmington, NC 28405
* * * * *
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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.
Sec. 520.88g [Amended]
0
4. In Sec. 520.88g, in paragraphs (c)(1)(ii) and (c)(2)(ii), in the
first sentence, remove ``nonbeta-lactamase'' and in its place add
``non-beta-lactamase''.
0
5. In Sec. 520.304, remove paragraph (b)(3) and revise paragraphs
(b)(1) and (2) to read as follows:
Sec. 520.304 Carprofen.
* * * * *
(b) * * *
(1) Nos. 054771, 026637, 055529, and 062250 for use of products
described in paragraph (a) as in paragraph (d) of this section.
(2) No. 000859 for use of product described in paragraph (a)(1) as
in paragraph (d) of this section.
* * * * *
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. In Sec. 522.304, revise paragraph (b) to read as follows:
Sec. 522.304 Carprofen.
* * * * *
(b) Sponsors. See Nos. 016729, 026637, 054771, and 055529 in Sec.
510.600(c) of this chapter.
* * * * *
0
8. In Sec. 522.970, revise paragraph (b)(1); remove paragraphs (b)(3),
(e)(2)(ii)(B), and (e)(2)(iii); and add two sentences after the italic
heading of paragraph (e)(2)(ii), to read as follows:
Sec. 522.970 Flunixin.
* * * * *
(b) * * *
(1) See Nos. 000061, 000859, 055529, 057561, and 061623 for use as
in paragraph (e) of this section.
* * * * *
(e) * * *
(2) * * *
(ii) Limitations. Approved only for intravenous administration in
cattle. Intramuscular administration has resulted in violative residues
in the edible tissues of cattle sent to slaughter. * * *
* * * * *
0
9. In Sec. 522.1002, revise paragraph (b)(1) to read as follows:
Sec. 522.1002 Follicle stimulating hormone.
* * * * *
(b)(1) Specifications--(i) Single pack. Each package contains 2
vials. One vial contains 700 international units (IU) porcine-
pituitary-derived follicle stimulating hormone (FSH) equivalent to 400
milligrams NIH-FSH-P1, as a dry powder. The other vial contains 20
milliliters (mL) of bacteriostatic sodium chloride injection. When
constituted, each milliliter of solution contains 35 IU FSH.
(ii) Dual pack. Each package contains 2 vials. Each vial contains
700 international units (IU) porcine-pituitary-derived FSH equivalent
to 400 milligrams NIH-FSH-P1, as a dry powder. Constitute with 20 mL
bacteriostatic sodium chloride injection, using strict aseptic
technique. When constituted, each milliliter of solution contains 35 IU
FSH.
* * * * *
0
10. In Sec. 522.1660a, revise the first sentence of paragraph
(e)(1)(ii) to read as follows:
Sec. 522.1660a Oxytetracycline solution, 200 milligrams/milliliter.
* * * * *
(e) * * *
(1) * * *
(ii) Limitations. Exceeding the highest recommended level of drug
per pound of bodyweight per day, administering more than the
recommended number of treatments, and/or exceeding 10 mL
intramuscularly or subcutaneously per injection site in adult beef and
dairy cattle may result in antibiotic residues beyond the withdrawal
time. * * *
* * * * *
0
11. In Sec. 522.2477, revise paragraph (b)(2) and the first sentence
in paragraphs (d)(1)(iii), (d)(2)(iii), (d)(3)(iii), and (d)(4)(iii);
and add paragraph (d)(5) 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), (d)(4), and (d)(5) of this section.
* * * * *
(d) * * *
(1) * * *
(iii) Limitations. Administer implant subcutaneously in the ear
only. * * *
(2) * * *
(iii) Limitations. Administer implant subcutaneously in the ear
only. * * *
(3) * * *
(iii) Limitations. Administer implant subcutaneously in the ear
only. * * *
(4) * * *
(iii) Limitations. Administer implant subcutaneously in the ear
only. * * *
(5) Beef heifers fed in confinement for slaughter--(i) Amount. Each
extended-release implant contains 200 mg trenbolone acetate and 20 mg
estradiol (one implant consisting of 6 coated and 4 uncoated pellets,
each pellet containing 20 mg trenbolone acetate and 2 mg estradiol).
(ii) Indications for use. For increased rate of weight gain and
improved feed efficiency for up to 200 days after implantation.
(iii) Limitations. Administer 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
[[Page 43485]]
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 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
12. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
13. In Sec. 524.998, add paragraph (c)(2) to read as follows:
Sec. 524.998 Fluralaner.
* * * * *
(c) * * *
(2) Cats--(i) Amount. Administer topically as a single dose every
12 weeks according to the label dosage schedule to provide a minimum
dose of 18.2 mg/lb (40 mg/kg) body weight. May be administered every 8
weeks in case of potential exposure to D. variabilis ticks.
(ii) Indications for use. Kills adult fleas; for the treatment and
prevention of flea infestations (C. felis) and the treatment and
control of I. scapularis (black-legged tick) infestations for 12 weeks
in cats and kittens 6 months of age and older, and weighing 2.6 lb or
greater; for the treatment and control of D. variabilis (American dog
tick) infestations for 8 weeks in cats and kittens 6 months of age and
older, and weighing 2.6 lb or greater.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
14. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
15. In Sec. 558.4, in paragraph (d), in the ``Category II'' table,
revise the row entries for ``Neomycin'' and ``Oxytetracycline'' to read
as follows:
Sec. 558.4 Requirement of a medicated feed mill license.
* * * * *
(d) * * *
Category II
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Assay limits Assay limits
Drug percent Type A Type B maximum (100x) percent Type B/
\1\ C \2\
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* * * * * * *
Neomycin...................................... 80-120 20 g/lb (4.4%).................. 70-125
Oxytetracycline............................... 80-120 20 g/lb (4.4%).................. 65-135
* * * * * * *
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\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
range limit, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed.
These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B
medicated feed with lower assay limits to make a Type C medicated feed.
* * * * *
Sec. 558.128 [Amended]
0
16. In Sec. 558.128, in paragraphs (e)(4)(iii) and (xii) and
(e)(5)(ii) and (iii), in the ``Sponsor'' column, add ``069254'' after
``054771''; in paragraphs (e)(4)(xi) and (xiii), in the ``Limitations''
column, remove the third sentence ``Withdraw 24 hours prior to
slaughter.''; and in paragraph (e)(6)(v), remove ``Sponsor. See No.
054771'' and in its place add ``Sponsors. See Nos. 054771 and 069254''.
Sec. 558.625 [Amended]
0
17. Amend Sec. 558.625 as follows:
0
a. In paragraphs (e)(1)(vii) and (ix), in the ``Tylosin grams/ton''
column, remove ``40 to 100'' and in its place add ``40 or 100'';
0
b. In paragraph (e)(2)(ii), in the ``Limitations'' column, add ``See
Sec. Sec. 558.311(d) and 558.342(d) in this chapter.'' after the last
sentence;
0
c. In paragraph (e)(2)(iii), in the ``Limitations '' column, add ``See
Sec. 558.342(d) in this chapter.'' after the last sentence;
0
d. In paragraph (e)(2)(vi), in the ``Limitations'' column, remove ``See
Sec. 558.355(d) in this chapter'' and in its place add ``See
Sec. Sec. 558.311(d) and 558.355(d) in this chapter.'';
0
e. In paragraph (e)(2)(vii), in the ``Limitations'' column, remove
``See Sec. 558.355(d) in this chapter'' and in its place add ``See
Sec. Sec. 558.342(d) and 558.355(d) in this chapter.'';
0
f. In paragraphs (e)(2)(viii), (ix), and (x), in the ``Limitations''
column, remove ``See Sec. 558.355(d) in this chapter'' and in its
place add ``See Sec. Sec. 558.355(d) and 558.500(d) in this chapter.''
0
g. In paragraph (e)(2)(xi) in the ``Limitations'' column, remove ``See
Sec. 558.355(d) in this chapter.'' and in its place add ``See
Sec. Sec. 558.342(d), 558.355(d), and 558.500(d) in this chapter.'';
0
h. In paragraphs (e)(2)(xii) and (xiii), in the ``Limitations'' column,
remove ``See Sec. 558.355(d) in this chapter.'' and in its place add
``See Sec. Sec. 558.355(d) and 558.665(d) in this chapter.''; and
0
i. In paragraphs (e)(2)(xiv) and (xv), in the ``Limitations'' column,
remove ``See Sec. 558.355(d) in this chapter.'' and in its place add
``See Sec. Sec. 558.342(d), 558.355(d) and 558.665(d) in this
chapter.''
Dated: September 7, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19602 Filed 9-15-17; 8:45 am]
BILLING CODE 4164-01-P