[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
         Approval date           File No.       Sponsor        Product name        Species      Effect of the action           Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
------------------------------------------------------------------------
 
                                * * * * *
Pharmgate LLC, 1800 Sir Tyler Dr., Wilmington, NC 28405.....     069254
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
        Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
069254...........................  Pharmgate LLC, 1800 Sir Tyler Dr.,
                                    Wilmington, NC 28405
 
                                * * * * *
------------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
                                                 Assay limits                                      Assay limits
                     Drug                       percent Type A        Type B maximum (100x)       percent Type B/
                                                      \1\                                              C \2\
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Neomycin......................................          80-120  20 g/lb (4.4%)..................          70-125
Oxytetracycline...............................          80-120  20 g/lb (4.4%)..................          65-135
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\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