Document ID: FDA-2014-N-0002-0040
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost
Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts;
Salinomycin; Ractopamine; Tylosin
Posted Date: 2014-07-31T04:00Z

[Federal Register Volume 79, Number 147 (Thursday, July 31, 2014)]
[Rules and Regulations]
[Pages 44277-44278]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17912]

[[Page 44277]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 522, 529, and 558

[Docket No. FDA-2014-N-0002]

New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost 
Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; 
Salinomycin; Ractopamine; Tylosin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval actions for new animal drug 
applications (NADAs) and abbreviated new animal drug applications 
(ANADAs) during June 2014. 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 remove a cross-reference to a combination drug 
medicated feed that is no longer codified.

DATES: This rule is effective July 31, 2014.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9019, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations 
to reflect approval actions for NADAs and ANADAs during June 2014 as 
listed in table 1. In addition, FDA is informing the public of the 
availability, where applicable, of documentation of environmental 
review under the National Environmental Policy Act (NEPA) and, for 
actions requiring review of safety or effectiveness data, summaries of 
the basis of approval (FOI Summaries) under the Freedom of Information 
Act (FOIA). These public documents may be seen in the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., 
Monday through Friday. Persons with access to the Internet may obtain 
these documents at the Center for Veterinary Medicine (CVM) FOIA 
Electronic Reading Room: http://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: 
http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
    Also, the regulations are being amended in 21 CFR 558.76 to remove 
a cross-reference to a combination drug medicated feed which was 
removed in earlier corrections to part 558 (79 FR 10976, February 27, 
2014). This amendment is being made to improve the accuracy 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.

                  Table 1--Original and Supplemental NADAs and ANADAs Approved During June 2014
----------------------------------------------------------------------------------------------------------------
                                     New animal drug                         21 CFR        FOIA          NEPA
  NADA/  ANADA        Sponsor          product name          Action         Sections      Summary       Review
----------------------------------------------------------------------------------------------------------------
108-901........  Zoetis Inc., 333   LUTALYSE           Supplemental          522.690,  yes.........  CE\1\ \2\
                  Portage St.,       (dinoprost         approval of         522.1077,
                  Kalamazoo, MI      injection)         label references     529.1940
                  49007.             Injection.         to approved uses
                                                        with gonadorelin
                                                        hydrochloride
                                                        injection and
                                                        progesterone
                                                        intravaginal
                                                        inserts.
128-686........  Zoetis Inc., 333   BIO-COX 60         Supplemental             558.4  no..........  CE\1\ \2\
                  Portage St.,       (salinomycin       approval of
                  Kalamazoo, MI      sodium) Type A     revised assay
                  49007.             medicated          limits for Type
                                     article.           A medicated
                                                        articles.
200-473 \3\....  Huvepharma AD,     TYLOVET (tylosin   Supplemental          520.2640  no..........  CE\1\ \2\
                  5th Floor, 3A,     tartrate)          approval of a
                  Nikolay Haytov     Soluble.           change in
                  Str., 1113                            marketing status
                  Sophia, Bulgaria.                     from over-the-
                                                        counter (OTC) to
                                                        by veterinary
                                                        prescription
                                                        (Rx).
200-560........  Zoetis Inc., 333   ACTOGAIN           Original approval      558.500  yes.........  CE\1\ \2\
                  Portage St.,       (ractopamine       as a generic
                  Kalamazoo, MI      HCl), RUMENSIN     copy of NADA 141-
                  49007.             (monensin), MGA    234.
                                     (melengestrol
                                     acetate), and
                                     Type B and C
                                     medicated feeds.
200-562........  Zoetis Inc., 333   ACTOGAIN           Original approval      558.500  yes.........  CE\1\ \2\
                  Portage St.,       (ractopamine       as a generic
                  Kalamazoo, MI      HCl), RUMENSIN     copy of NADA 141-
                  49007.             (monensin),        233.
                                     TYLAN (tylosin
                                     phosphate), and
                                     MGA
                                     (melengestrol
                                     acetate) Type B
                                     and C medicated
                                     feeds.
----------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the
  requirement to submit an environmental assessment or an environmental impact statement because it is of a type
  that does not individually or cumulatively have a significant effect on the human environment.
\2\ CE granted under 21 CFR 25.33(a)(1).
\3\ The application listed was identified as being affected by guidance for industry (GFI) 213, ``New
  Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water
  of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions
  with GFI 209'', December 2013.

[[Page 44278]]

List of Subjects

21 CFR Parts 520, 522, and 529

    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 520, 
522, 529, and 558 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

Sec.  520.2640  [Amended]

0
2. In Sec.  520.2640, in paragraphs (b)(1) and (d) remove ``No. 
000986'' and in its place add ``Nos. 000986 and 016592''; and in 
paragraph (b)(2) remove ``Nos. 016592 and 061623'' and in its place add 
``No. 061623''.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
4. In Sec.  522.690, revise the section heading and paragraph (d)(2)(v) 
to read as follows:

Sec.  522.690  Dinoprost.

* * * * *
    (d) * * *
    (2) * * *
    (v) Dinoprost injection as provided by No. 054771 in Sec.  
510.600(c) of this chapter may also be used concurrently with 
gonadorelin hydrochloride injection as in Sec.  522.1077 and with 
progesterone intravaginal inserts as in Sec.  529.1940 of this chapter.
* * * * *

0
5. In Sec.  522.1077, revise paragraph (c)(1)(ii) to read as follows:

Sec.  522.1077  Gonadorelin hydrochloride.

* * * * *
    (c) * * *
    (1) * * *
    (ii) For use with dinoprost injection to synchronize estrous cycles 
to allow fixed-time artificial insemination (FTAI) in lactating dairy 
cows, administer to each cow 100 to 200 mcg gonadorelin by 
intramuscular injection, followed 6 to 8 days later by 25 mg dinoprost 
by intramuscular injection, followed 30 to 72 hours later by 100 to 200 
mcg gonadorelin by intramuscular injection. Dinoprost injection as in 
Sec.  522.690, provided by No. 054771 in Sec.  510.600(c) of this 
chapter.
* * * * *

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
6. The authority citation for 21 CFR part 529 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
7. In Sec.  529.1940, revise paragraph (d), the second sentence in 
paragraph (e)(1)(i) and the last sentence in paragraph (e)(1)(iii) to 
read as follows:

Sec.  529.1940  Progesterone intravaginal inserts.

* * * * *
    (d) Special considerations. Product labeling shall bear the 
following warning: ``Avoid contact with skin by wearing protective 
gloves when handling inserts. Store removed inserts in a sealable 
container until they can be disposed of in accordance with applicable 
local, state, and Federal regulations.''
    (e) * * *
    (1) * * *
    (i) * * * When used for indications listed in paragraph 
(e)(1)(ii)(A) of this section, administer 25 mg dinoprost as a single 
intramuscular injection 1 day prior to insert removal (Day 6). * * *
* * * * *
    (iii) * * * Dinoprost injection for use in paragraphs (e)(1)(ii)(A) 
and (e)(1)(ii)(B) of this section as in Sec.  522.690 of this chapter, 
provided by No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
8. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

Sec.  558.4  [Amended]

0
9. In paragraph (d) of Sec.  558.4, in the ``Category I'' table, in the 
``Assay limits percent type A'' column, in the entry for 
``Salinomycin'', remove ``95-115'' and in its place add ``90-110''.

Sec.  558.76  [Amended]

0
10. In Sec.  558.76, remove and reserve paragraph (d)(3)(vii).

Sec.  558.500  [Amended]

0
11. In Sec.  558.500, in the table in paragraphs (e)(2)(viii) and 
(e)(2)(x), in the ``Sponsor'' column, remove ``000986'' and in its 
place add ``000986, 054771''.

    Dated: July 24, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-17912 Filed 7-30-14; 8:45 am]
BILLING CODE 4164-01-P