80_FR_34391 80 FR 34276 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor

80 FR 34276 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 115 (June 16, 2015)

Page Range34276-34279
FR Document2015-14734

The Food and Drug Administration (FDA) 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 March and April 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect several nonsubstantive changes. These technical amendments are being made to improve the accuracy of the regulations.

Federal Register, Volume 80 Issue 115 (Tuesday, June 16, 2015) 
[Federal Register Volume 80, Number 115 (Tuesday, June 16, 2015)]
[Rules and Regulations]
[Pages 34276-34279]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14734]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 526, and 528

[Docket No. FDA-2015-N-0002]


New Animal Drugs; Approval of New Animal Drug Applications; 
Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect application-related actions for new animal 
drug applications (NADAs) and

[[Page 34277]]

abbreviated new animal drug applications (ANADAs) during March and 
April 2015. FDA is also informing the public of the availability of 
summaries of the basis of approval and of environmental review 
documents, where applicable. The animal drug regulations are also being 
amended to reflect several nonsubstantive changes. These technical 
amendments are being made to improve the accuracy of the regulations.

DATES: This rule is effective June 16, 2015.

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, 
[email protected].

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations 
to reflect approval actions for NADAs and ANADAs during March and April 
2015, 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: 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.

                                Table 1--Original and Supplemental NADAs and ANADAs Approved During March and April 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                New animal drug product                               21 CFR
    NADA/ANADA               Sponsor                     name                     Action             sections       FOIA summary         NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
200-557...........  Putney, Inc., One          Tiletamine-Zolazepam      Original approval as a       522.2470  yes................  CE \1\ \2\.
                     Monument Sq., suite 400,   Injectable Solution       generic copy of NADA
                     Portland, ME 04101.        (tiletamine HCl and       106-111.
                                                zolazepam HCl).
200-578...........  Belcher Pharmaceuticals,   Carprofen Flavored        Original approval as a        520.304  yes................  CE \1\ \2\.
                     LLC, 6911 Bryan Dairy      Tablets (carprofen).      generic copy of NADA
                     Rd., Largo, FL 33777.                                141-053.
200-579...........  Ceva Sant[eacute]          Altrenogest Solution      Original approval as a         520.48  yes................  CE \1\ \2\.
                     Animale, 10 Avenue de la   (altrenogest).            generic copy of NADA
                     Ballasti[egrave]re,                                  141-222.
                     33500 Libourne, France.
141-238...........  Zoetis Inc., 333 Portage   SPECTRAMAST LC            Supplemental approval         526.313  yes................  CE \1\ \3\.
                     St., Kalamazoo, MI 49007.  (ceftiofur intramammary   for treatment of
                                                suspension) Sterile       diagnosed subclinical
                                                Suspension.               mastitis associated
                                                                          with coagulase-negative
                                                                          staphylococci and
                                                                          Streptococcus
                                                                          dysgalactiae in
                                                                          lactating dairy cattle.
200-134...........  Intervet, Inc., 2 Giralda  FERTAGYL (gonadorelin)    Supplemental approval        522.1077  yes................  EA/FONSI \4\.
                     Farms, Madison, NJ 07940.  Sterile Solution.         under section 512(b)(1)
                                                                          of the FD&C Act for use
                                                                          with cloprostenol
                                                                          injection to
                                                                          synchronize estrous
                                                                          cycles to allow for
                                                                          fixed time artificial
                                                                          insemination (FTAI) in
                                                                          lactating dairy cows.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined 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 have a significant effect on the human environment.
\2\ CE granted under 21 CFR 25.33(a)(1).
\3\ CE granted under 21 CFR 25.33(d)(5).
\4\ 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).

    In addition during March and April 2015, ownership of, and all 
rights and interest in, the following approved applications have been 
transferred as follows:

----------------------------------------------------------------------------------------------------------------
                                                New animal drug product                                 21 CFR
    NADA/ANADA           Previous sponsor                 name                   New sponsor           section
----------------------------------------------------------------------------------------------------------------
140-883...........  Bayer HealthCare LLC,      LEGEND (hyaluronate        Merial, Inc., 3239            522.1145
                     Animal Health Division,    sodium) Injectable         Satellite Blvd., Bldg.
                     P.O. Box 390, Shawnee,     Solution.                  500, Duluth, GA 30096.
                     Mission, KS 66201.
141-188...........  Bayer HealthCare LLC,      MARQUIS (ponazuril)        Merial, Inc., 3239            520.1855
                     Animal Health Division,    Antiprotozoal Oral Paste.  Satellite Blvd., Bldg.
                     P.O. Box 390, Shawnee,                                500, Duluth, GA 30096.
                     Mission, KS 66201.
141-294...........  rEVO Biologics, 175        Bc6 rDNA construct in GTC  LFB USA, Inc., 175            528.1070
                     Crossing Blvd.,            155-92 goats.              Crossing Blvd.,
                     Framingham, MA 01702.                                 Framingham, MA 01702.
----------------------------------------------------------------------------------------------------------------

At this time, the regulations are being amended to reflect these 
changes of sponsorship.
    Following these changes of sponsorship, LFB USA, Inc., is now the 
sponsor of an approved application. Accordingly, Sec.  510.600 (21 CFR 
510.600) is being amended to add this

[[Page 34278]]

firm to the list of sponsors of approved applications.
    The animal drug regulations are also being amended to reflect 
several non-substantive changes. These technical amendments are 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.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, 526, and 528

    Animal drugs.

    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, 526, and 528 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    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), remove the entry 
for ``Abbott Laboratories'' and add in alphabetical order an entry for 
``LFB USA, Inc.''; and in the table in paragraph (c)(2), remove the 
entry for 000044 and add in numerical order an entry for ``086047'' to 
read as follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                                * * * * *
LFB USA, Inc., 175 Crossing Blvd., Framingham, MA 01702.          086047
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
           Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
086047.................................  LFB USA, Inc., 175 Crossing
                                          Blvd., Framingham, MA 01702
 
                                * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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


0
4. In Sec.  520.48, revise paragraph (b) to read as follows:


Sec.  520.48  Altrenogest.

* * * * *
    (b) Sponsors. See Nos. 000061 and 013744 in Sec.  510.600(c) of 
this chapter.
* * * * *


Sec.  520.88g  [Amended]

0
5. In Sec.  520.88g, in paragraph (c)(2)(i), remove ``(1 milliliter)''.
0
6. In Sec.  520.154a:
0
a. Revise the section heading;
0
b. In paragraphs (d)(1)(ii), (d)(2)(i)(A), (d)(2)(ii)(A), and 
(d)(4)(ii), remove ``bacitracin methylene disalicylate'' and in its 
place add ``bacitracin methylenedisalicylate''; and
0
c. In paragraph (d)(3)(ii), remove ``Treponema hyodysenteriae'' and in 
its place add ``Brachyspira hyodysenteriae''.
    The revision reads as follows:


Sec.  520.154a  Bacitracin methylenedisalicylate.

* * * * *


Sec.  520.304  [Amended]

0
7. In Sec.  520.304, in paragraph (b)(3), remove ``No. 026637'' and in 
its place add ``Nos. 026637 and 062250''.


Sec.  520.804  [Amended]

0
8. In Sec.  520.804, redesignate paragraphs (c)(i), (c)(ii), and 
(c)(iii), as paragraphs (c)(1), (c)(2), and (c)(3).

0
9. In Sec.  520.1660d, revise paragraph (a)(4) to read as follows:


Sec.  520.1660d  Oxytetracycline powder.

    (a) * * *
    (4) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 
2.46 and 9.87 oz, 3.09 and 3.91 lb; pail: 3.09 lb).
* * * * *


Sec.  520.1855  [Amended]

0
10. In Sec.  520.1855, in paragraph (b), remove ``000859'' and in its 
place add ``050604''.

0
11. In Sec.  520.2218, revise paragraphs (d)(1)(i)(A) and (B), and 
paragraphs (d)(2)(i)(A) and (B) to read as follows:


Sec.  520.2218  Sulfamerazine, sulfamethazine, and sulfaquinoxaline 
powder.

* * * * *
    (d) * * *
    (1) * * *
    (i) * * *
    (A) As an aid in the control of coccidiosis caused by Eimeria 
tenella and E. necatrix susceptible to sulfamerazine, sulfamethazine, 
and sulfaquinoxaline: Provide medicated water (0.04 percent solution) 
for 2 to 3 days, then plain water for 3 days, then medicated water 
(0.025 percent solution) for 2 days. If bloody droppings appear, repeat 
at 0.025 percent level for 2 more days. Do not change litter.
    (B) As an aid in the control of acute fowl cholera caused by 
Pasteurella multocida susceptible to sulfamerazine, sulfamethazine, and 
sulfaquinoxaline: Provide medicated water (0.04 percent solution) for 2 
to 3 days. If disease recurs, repeat treatment.
* * * * *
    (2) * * *
    (i) * * *
    (A) As an aid in the control of coccidiosis caused by Eimeria 
meleagrimitis and E. adenoeides susceptible to sulfamerazine, 
sulfamethazine, and sulfaquinoxaline: Provide medicated water (0.025 
percent solution) for 2 days, then plain water for 3 days, then 
medicated water (0.025 percent solution) for 2 days, then plain water 
for 3 days, then medicated water (0.025 percent solution) for 2 days. 
Repeat if necessary. Do not change litter.
    (B) As an aid in the control of acute fowl cholera caused by 
Pasteurella multocida susceptible to sulfamerazine, sulfamethazine, and 
sulfaquinoxaline: Provide medicated water (0.04 percent solution) for 2 
to 3 days. If disease recurs, repeat treatment.
* * * * *


Sec.  520.2640  [Amended]

0
12. In Sec.  520.2640, in paragraphs (e)(2)(iii) and (e)(3)(iii), 
remove the first sentence.

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

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

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


Sec. Sec.  522.1073 and 522.1075  [Removed]

0
14. Remove Sec. Sec.  522.1073 and 522.1075.

[[Page 34279]]


0
15. Revise Sec.  522.1077 to read as follows:


Sec.  522.1077  Gonadorelin.

    (a) Specifications. Each milliliter (mL) of solution contains:
    (1) 43 micrograms ([micro]g) of gonadorelin as gonadorelin acetate;
    (2) 100 [micro]g of gonadorelin as gonadorelin acetate;
    (3) 50 [micro]g of gonadorelin as gonadorelin diacetate 
tetrahydrate; or
    (4) 50 [micro]g of gonadorelin as gonadorelin hydrochloride.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter.
    (1) No. 000061 for use of the 43-[micro]g/mL product described in 
paragraph (a)(1) as in paragraphs (d)(1)(i), (d)(1)(iv), and (d)(2) of 
this section.
    (2) No. 068504 for use of the 100-[micro]g/mL product described in 
paragraph (a)(2) as in paragraphs (d)(1)(ii), (d)(1)(v), and (d)(2) of 
this section.
    (3) Nos. 000859 and 050604 for use of the 50-[micro]g/mL product 
described in paragraph (a)(3) as in paragraphs (d)(1)(ii) and (d)(2) of 
this section.
    (4) No. 054771 for use of the 50-[micro]g/mL product described in 
paragraph (a)(4) as in paragraphs (d)(1)(iii), (d)(1)(vi), and (d)(2) 
of this section.
    (c) Special considerations. Concurrent luteolytic drug use is 
approved as follows:
    (1) Cloprostenol injection for use as in paragraph (d)(1)(iv) of 
this section as provided by No. 000061 in Sec.  510.600(c) of this 
chapter.
    (2) Cloprostenol injection for use as in paragraph (d)(1)(v) of 
this section as provided by No. 000061 or No. 068504 in Sec.  
510.600(c) of this chapter.
    (3) Dinoprost injection for use as in paragraph (d)(1)(vi) of this 
section as provided by No. 054771 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use in cattle--(1) Indications for use and 
amounts--(i) For the treatment of ovarian follicular cysts in dairy 
cattle: Administer 86 [mu]g gonadorelin by intramuscular or intravenous 
injection.
    (ii) For the treatment of ovarian follicular cysts in dairy cattle: 
Administer 100 [mu]g gonadorelin by intramuscular or intravenous 
injection.
    (iii) For the treatment of ovarian follicular cysts in cattle: 
Administer 100 [mu]g gonadorelin by intramuscular injection.
    (iv) For use with cloprostenol injection to synchronize estrous 
cycles to allow for fixed-time artificial insemination (FTAI) in 
lactating dairy cows: Administer to each cow 86 [mu]g gonadorelin by 
intramuscular injection, followed 6 to 8 days later by 500 [mu]g 
cloprostenol by intramuscular injection, followed 30 to 72 hours later 
by 86 [mu]g gonadorelin by intramuscular injection.
    (v) For use with cloprostenol injection to synchronize estrous 
cycles to allow for fixed-time artificial insemination (FTAI) in 
lactating dairy cows and beef cows: Administer to each cow 100 [mu]g 
gonadorelin by intramuscular injection, followed 6 to 8 days later by 
500 [mu]g cloprostenol by intramuscular injection, followed 30 to 72 
hours later by 100 [mu]g gonadorelin by intramuscular injection.
    (vi) 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 [mu]g 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 
[mu]g gonadorelin by intramuscular injection.
    (2) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.


Sec.  522.1145  [Amended]

0
16. In Sec.  520.1145, in paragraph (e)(2)(i), remove ``000859'' and in 
its place add ``050604''.

0
17. In Sec.  522.2470, revise paragraph (b) to read as follows:


Sec.  522.2470  Tiletamine and zolazepam for injection.

* * * * *
    (b) Sponsors. See Nos. 026637 and 054771 in Sec.  510.600(c) of 
this chapter.
* * * * *

0
18. In Sec.  522.2483, revise paragraph (b) to read as follows:


Sec.  522.2483  Triamcinolone.

* * * * *
    (b) Sponsors. See Nos. 000010 and 054628 in Sec.  510.600(c) of 
this chapter.
* * * * *

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

0
19. The authority citation for 21 CFR part 526 continues to read as 
follows:

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


0
20. In Sec.  526.313, revise paragraph (d)(1)(ii) to read as follows:


Sec.  526.313  Ceftiofur.

* * * * *
    (d) * * *
    (1) * * *
    (ii) Indications for use. For use in lactating dairy cattle:
    (A) For the treatment of clinical mastitis associated with 
coagulase-negative staphylococci, Streptococcus dysgalactiae, and 
Escherichia coli; and
    (B) For the treatment of diagnosed subclinical mastitis associated 
with coagulase-negative staphylococci and S. dysgalactiae.
* * * * *

PART 528--NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS

0
21. The authority citation for 21 CFR part 528 continues to read as 
follows:

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


Sec.  528.1070  [Amended]

0
22. In Sec.  528.1070, in paragraph (b), remove ``042976'' and in its 
place add ``086047''.

    Dated: June 11, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-14734 Filed 6-15-15; 8:45 am]
 BILLING CODE 4164-01-P

34276 Federal Register / Vol. 80, No. 115 / Tuesday, June 16, 2015 / Rules and Regulations individually or cumulatively have a 331(ll)). Section 301(ll) of the FD&C Act ■ b. Redesignate paragraphs (b) and (c) significant effect on the human prohibits the introduction or delivery as paragraphs (c) and (d), respectively; environment such that neither an for introduction into interstate and environmental assessment nor an commerce of any food that contains a ■ c. Add new paragraph (b). environmental impact statement is drug approved under section 505 of the The revision and addition read as required. We have not received any new FD&C Act (21 U.S.C. 355), a biological follows: information or comments that would product licensed under section 351 of § 172.185 TBHQ. affect that determination. the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for * * * * * VII. Paperwork Reduction Act of 1995 (a) The food additive has a melting which substantial clinical investigations This final rule contains no collection point of not less than 126.5 °C. have been instituted and their existence (b) The percentage of TBHQ in the of information. Therefore, clearance by has been made public, unless one of the the Office of Management and Budget food additive is not less than 99.0 exemptions in section 301(ll)(1) to (4) of percent when tested by the assay under the Paperwork Reduction Act of the FD&C Act applies. In our review of 1995 is not required. described in the Food Chemicals Codex, this petition, we did not consider 9th ed. (2014), pp. 1192–1194, which is VIII. Objections whether section 301(ll) of the FD&C Act incorporated by reference, or an or any of its exemptions apply to food equivalent method. The Director of the If you will be adversely affected by containing this additive. Accordingly, Office of the Federal Register approves one or more provisions of this this final rule should not be construed this incorporation by reference in regulation, you may file with the to be a statement that a food containing accordance with 5 U.S.C. 552(a) and 1 Division of Dockets Management (see this additive, if introduced or delivered CFR part 51. You may obtain copies ADDRESSES) either electronic or written for introduction into interstate from the United States Pharmacopeial objections. You must separately number commerce, would not violate section Convention, 12601 Twinbrook Pkwy., each objection, and within each 301(ll) of the FD&C Act. Furthermore, Rockville, MD 20852 (Internet address: numbered objection you must specify this language is included in all food http://www.usp.org). Copies may be with particularity the provision(s) to additive final rules and therefore should examined at the Food and Drug which you object, and the grounds for not be construed to be a statement of the Administration’s Main Library, 10903 your objection. Within each numbered likelihood that section 301(ll) of the New Hampshire Ave., Bldg. 2, Third objection, you must specifically state FD&C Act applies. Floor, Silver Spring, MD 20993, 301– whether you are requesting a hearing on the particular provision that you specify X. References 796–2039, or at the National Archives in that numbered objection. If you do and Records Administration (NARA). not request a hearing for any particular The following references have been For information on the availability of objection, you waive the right to a placed on display in the Division of this material at NARA, call 202–741– hearing on that objection. If you request Dockets Management (see ADDRESSES) 6030 or go to: http://www.archives.gov/ a hearing, your objection must include and may be seen by interested persons federal-register/cfr/ibr-locations.html. a detailed description and analysis of between 9 a.m. and 4 p.m., Monday through Friday, and are available * * * * * the specific factual information you Dated: June 9, 2015. intend to present in support of the electronically at http:// objection in the event that a hearing is www.regulations.gov. Susan Bernard, held. If you do not include such a 1. FDA Memorandum from H. Lee, to E. Director, Office of Regulations, Policy and Anderson, June 18, 2014. Social Sciences, Center for Food Safety and description and analysis for any Applied Nutrition. particular objection, you waive the right 2. FDA Memorandum from A. Khan to E. Anderson, August 6, 2014. [FR Doc. 2015–14704 Filed 6–15–15; 8:45 am] to a hearing on the objection. BILLING CODE 4164–01–P It is only necessary to send one set of List of Subjects in 21 CFR Part 172 documents. Identify documents with the docket number found in brackets in the Food additives, Incorporation by reference, Reporting and recordkeeping DEPARTMENT OF HEALTH AND heading of this document. Any requirements. HUMAN SERVICES objections received in response to the regulation may be seen in the Division Therefore, under the Federal Food, Food and Drug Administration of Dockets Management between 9 a.m. Drug, and Cosmetic Act and under and 4 p.m., Monday through Friday, and authority delegated to the Commissioner 21 CFR Parts 510, 520, 522, 526, and will be posted to the docket at http:// of Food and Drugs and redelegated to 528 www.regulations.gov. the Director, Center for Food Safety and Applied Nutrition, 21 CFR part 172 is [Docket No. FDA–2015–N–0002] IX. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act amended as follows: New Animal Drugs; Approval of New Our review of this petition was PART 172—FOOD ADDITIVES Animal Drug Applications; Change of limited to section 409 of the Federal PERMITTED FOR DIRECT ADDITION Sponsor Food, Drug, and Cosmetic Act (the TO FOOD FOR HUMAN AGENCY: Food and Drug Administration, FD&C Act) (21 U.S.C. 348). This final CONSUMPTION HHS. asabaliauskas on DSK5VPTVN1PROD with RULES rule is not a statement regarding Final rule; technical ACTION: compliance with other sections of the ■ 1. The authority citation for 21 CFR amendments. FD&C Act. For example, the Food and part 172 continues to read as follows: Drug Administration Amendments Act Authority: 21 U.S.C. 321, 341, 342, 348, SUMMARY: The Food and Drug of 2007, which was signed into law on 371, 379e. Administration (FDA) is amending the September 27, 2007, amended the FD&C animal drug regulations to reflect Act to, among other things, add section ■ 2. Amend § 172.185 as follows: application-related actions for new 301(ll) of the FD&C Act (21 U.S.C. ■ a. Revise paragraph (a); animal drug applications (NADAs) and VerDate Sep<11>2014 16:14 Jun 15, 2015 Jkt 235001 PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 E:\FR\FM\16JNR1.SGM 16JNR1

Federal Register / Vol. 80, No. 115 / Tuesday, June 16, 2015 / Rules and Regulations 34277 abbreviated new animal drug Rockville, MD 20855, 240–402–5689, Food and Drug Administration, 5630 applications (ANADAs) during March george.haibel@fda.hhs.gov. Fishers Lane, rm. 1061, Rockville, MD and April 2015. FDA is also informing 20852, between 9 a.m. and 4 p.m., SUPPLEMENTARY INFORMATION: FDA is the public of the availability of Monday through Friday. Persons with amending the animal drug regulations to summaries of the basis of approval and access to the Internet may obtain these reflect approval actions for NADAs and of environmental review documents, documents at the CVM FOIA Electronic where applicable. The animal drug ANADAs during March and April 2015, as listed in table 1. In addition, FDA is Reading Room: http://www.fda.gov/ regulations are also being amended to AboutFDA/CentersOffices/ reflect several nonsubstantive changes. informing the public of the availability, where applicable, of documentation of OfficeofFoods/CVM/ These technical amendments are being CVMFOIAElectronicReadingRoom/ made to improve the accuracy of the environmental review required under the National Environmental Policy Act default.htm. Marketing exclusivity and regulations. patent information may be accessed in (NEPA) and, for actions requiring DATES: This rule is effective June 16, review of safety or effectiveness data, FDA’s publication, Approved Animal 2015. summaries of the basis of approval (FOI Drug Products Online (Green Book) at: FOR FURTHER INFORMATION CONTACT: Summaries) under the Freedom of http://www.fda.gov/AnimalVeterinary/ George K. Haibel, Center for Veterinary Information Act (FOIA). These public Products/ Medicine (HFV–6), Food and Drug documents may be seen in the Division ApprovedAnimalDrugProducts/ Administration, 7519 Standish Pl., of Dockets Management (HFA–305), default.htm. TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MARCH AND APRIL 2015 FOIA NADA/ 21 CFR Sponsor New animal drug product name Action sum- NEPA review ANADA sections mary 200–557 ..... Putney, Inc., One Monument Sq., Tiletamine-Zolazepam Injectable Original approval as a generic 522.2470 yes .. CE 1 2. suite 400, Portland, ME 04101. Solution (tiletamine HCl and copy of NADA 106–111. zolazepam HCl). 200–578 ..... Belcher Pharmaceuticals, LLC, Carprofen Flavored Tablets Original approval as a generic 520.304 yes .. CE 1 2. 6911 Bryan Dairy Rd., Largo, (carprofen). copy of NADA 141–053. FL 33777. 200–579 ..... Ceva Santé Animale, 10 Avenue Altrenogest Solution (altrenogest) Original approval as a generic 520.48 yes .. CE 1 2. de la Ballastière, 33500 copy of NADA 141–222. Libourne, France. 141–238 ..... Zoetis Inc., 333 Portage St., Kala- SPECTRAMAST LC (ceftiofur Supplemental approval for treat- 526.313 yes .. CE 1 3. mazoo, MI 49007. intramammary suspension) ment of diagnosed subclinical Sterile Suspension. mastitis associated with coagulase-negative staphylococci and Strepto- coccus dysgalactiae in lactating dairy cattle. 200–134 ..... Intervet, Inc., 2 Giralda Farms, FERTAGYL (gonadorelin) Sterile Supplemental approval under sec- 522.1077 yes .. EA/FONSI 4. Madison, NJ 07940. Solution. tion 512(b)(1) of the FD&C Act for use with cloprostenol injec- tion to synchronize estrous cy- cles to allow for fixed time artifi- cial insemination (FTAI) in lac- tating dairy cows. 1 The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an environmental im- pact statement because it is of a type that does not have a significant effect on the human environment. 2 CE granted under 21 CFR 25.33(a)(1). 3 CE granted under 21 CFR 25.33(d)(5). 4 The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of no signifi- cant impact (FONSI). In addition during March and April applications have been transferred as 2015, ownership of, and all rights and follows: interest in, the following approved NADA/ 21 CFR Previous sponsor New animal drug product name New sponsor ANADA section 140–883 ..... Bayer HealthCare LLC, Animal LEGEND (hyaluronate sodium) Merial, Inc., 3239 Satellite Blvd., 522.1145 Health Division, P.O. Box 390, Injectable Solution. Bldg. 500, Duluth, GA 30096. Shawnee, Mission, KS 66201. 141–188 ..... Bayer HealthCare LLC, Animal MARQUIS (ponazuril) Antiprotozoal Merial, Inc., 3239 Satellite Blvd., 520.1855 Health Division, P.O. Box 390, Oral Paste. Bldg. 500, Duluth, GA 30096. asabaliauskas on DSK5VPTVN1PROD with RULES Shawnee, Mission, KS 66201. 141–294 ..... rEVO Biologics, 175 Crossing Blvd., Bc6 rDNA construct in GTC 155–92 LFB USA, Inc., 175 Crossing Blvd., 528.1070 Framingham, MA 01702. goats. Framingham, MA 01702. At this time, the regulations are being Following these changes of Accordingly, § 510.600 (21 CFR amended to reflect these changes of sponsorship, LFB USA, Inc., is now the 510.600) is being amended to add this sponsorship. sponsor of an approved application. 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34278 Federal Register / Vol. 80, No. 115 / Tuesday, June 16, 2015 / Rules and Regulations firm to the list of sponsors of approved Drug labeler ■ 11. In § 520.2218, revise paragraphs Firm name and address applications. code (d)(1)(i)(A) and (B), and paragraphs The animal drug regulations are also (d)(2)(i)(A) and (B) to read as follows: being amended to reflect several non- * * * * * substantive changes. These technical 086047 .......... LFB USA, Inc., 175 Crossing § 520.2218 Sulfamerazine, sulfamethazine, Blvd., Framingham, MA and sulfaquinoxaline powder. amendments are being made to improve 01702 * * * * * the accuracy of the regulations. This rule does not meet the definition (d) * * * * * * * * of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because (1) * * * it is a rule of ‘‘particular applicability.’’ (i) * * * Therefore, it is not subject to the PART 520—ORAL DOSAGE FORM (A) As an aid in the control of congressional review requirements in 5 NEW ANIMAL DRUGS coccidiosis caused by Eimeria tenella U.S.C. 801–808. and E. necatrix susceptible to ■ 3. The authority citation for 21 CFR sulfamerazine, sulfamethazine, and List of Subjects part 520 continues to read as follows: sulfaquinoxaline: Provide medicated 21 CFR Part 510 Authority: 21 U.S.C. 360b. water (0.04 percent solution) for 2 to 3 Administrative practice and ■ 4. In § 520.48, revise paragraph (b) to days, then plain water for 3 days, then procedure, Animal drugs, Labeling, read as follows: medicated water (0.025 percent Reporting and recordkeeping solution) for 2 days. If bloody droppings requirements. § 520.48 Altrenogest. appear, repeat at 0.025 percent level for * * * * * 2 more days. Do not change litter. 21 CFR Parts 520, 522, 526, and 528 (b) Sponsors. See Nos. 000061 and (B) As an aid in the control of acute Animal drugs. 013744 in § 510.600(c) of this chapter. fowl cholera caused by Pasteurella Therefore, under the Federal Food, * * * * * multocida susceptible to sulfamerazine, Drug, and Cosmetic Act and under sulfamethazine, and sulfaquinoxaline: § 520.88g [Amended] Provide medicated water (0.04 percent authority delegated to the Commissioner of Food and Drugs and redelegated to ■ 5. In § 520.88g, in paragraph (c)(2)(i), solution) for 2 to 3 days. If disease the Center for Veterinary Medicine, 21 remove ‘‘(1 milliliter)’’. recurs, repeat treatment. CFR parts 510, 520, 522, 526, and 528 ■ 6. In § 520.154a: * * * * * are amended as follows: ■ a. Revise the section heading; (2) * * * ■ b. In paragraphs (d)(1)(ii), (d)(2)(i)(A), (i) * * * PART 510—NEW ANIMAL DRUGS (d)(2)(ii)(A), and (d)(4)(ii), remove (A) As an aid in the control of ‘‘bacitracin methylene disalicylate’’ and coccidiosis caused by Eimeria ■ 1. The authority citation for 21 CFR in its place add ‘‘bacitracin meleagrimitis and E. adenoeides part 510 continues to read as follows: methylenedisalicylate’’; and susceptible to sulfamerazine, Authority: 21 U.S.C. 321, 331, 351, 352, ■ c. In paragraph (d)(3)(ii), remove sulfamethazine, and sulfaquinoxaline: 353, 360b, 371, 379e. ‘‘Treponema hyodysenteriae’’ and in its Provide medicated water (0.025 percent place add ‘‘Brachyspira solution) for 2 days, then plain water for ■ 2. In § 510.600, in the table in hyodysenteriae’’. paragraph (c)(1), remove the entry for 3 days, then medicated water (0.025 The revision reads as follows: percent solution) for 2 days, then plain ‘‘Abbott Laboratories’’ and add in alphabetical order an entry for ‘‘LFB § 520.154a Bacitracin water for 3 days, then medicated water USA, Inc.’’; and in the table in methylenedisalicylate. (0.025 percent solution) for 2 days. paragraph (c)(2), remove the entry for * * * * * Repeat if necessary. Do not change litter. 000044 and add in numerical order an (B) As an aid in the control of acute § 520.304 [Amended] fowl cholera caused by Pasteurella entry for ‘‘086047’’ to read as follows: ■ 7. In § 520.304, in paragraph (b)(3), multocida susceptible to sulfamerazine, § 510.600 Names, addresses, and drug remove ‘‘No. 026637’’ and in its place sulfamethazine, and sulfaquinoxaline: labeler codes of sponsors of approved add ‘‘Nos. 026637 and 062250’’. Provide medicated water (0.04 percent applications. solution) for 2 to 3 days. If disease * * * * * § 520.804 [Amended] recurs, repeat treatment. (c) * * * ■ 8. In § 520.804, redesignate * * * * * (1) * * * paragraphs (c)(i), (c)(ii), and (c)(iii), as paragraphs (c)(1), (c)(2), and (c)(3). § 520.2640 [Amended] Drug labeler Firm name and address code ■ 9. In § 520.1660d, revise paragraph ■ 12. In § 520.2640, in paragraphs (a)(4) to read as follows: (e)(2)(iii) and (e)(3)(iii), remove the first sentence. * * * * * § 520.1660d Oxytetracycline powder. LFB USA, Inc., 175 Crossing (a) * * * PART 522—IMPLANTATION OR Blvd., Framingham, MA (4) Each 2.73 grams of powder INJECTABLE DOSAGE FORM NEW 01702 ................................ 086047 contains 1 gram of OTC HCl (packets: ANIMAL DRUGS asabaliauskas on DSK5VPTVN1PROD with RULES 2.46 and 9.87 oz, 3.09 and 3.91 lb; pail: * * * * * 3.09 lb). ■ 13. The authority citation for 21 CFR * * * * * part 522 continues to read as follows: (2) * * * Authority: 21 U.S.C. 360b. § 520.1855 [Amended] Drug labeler §§ 522.1073 and 522.1075 [Removed] Firm name and address ■ 10. In § 520.1855, in paragraph (b), code remove ‘‘000859’’ and in its place add ■ 14. Remove §§ 522.1073 and ‘‘050604’’. 522.1075. VerDate Sep<11>2014 16:14 Jun 15, 2015 Jkt 235001 PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 E:\FR\FM\16JNR1.SGM 16JNR1

Federal Register / Vol. 80, No. 115 / Tuesday, June 16, 2015 / Rules and Regulations 34279 ■ 15. Revise § 522.1077 to read as followed 30 to 72 hours later by 86 mg coagulase-negative staphylococci and S. follows: gonadorelin by intramuscular injection. dysgalactiae. (v) For use with cloprostenol injection * * * * * § 522.1077 Gonadorelin. to synchronize estrous cycles to allow (a) Specifications. Each milliliter (mL) for fixed-time artificial insemination PART 528—NEW ANIMAL DRUGS IN of solution contains: (FTAI) in lactating dairy cows and beef GENETICALLY ENGINEERED (1) 43 micrograms (mg) of gonadorelin cows: Administer to each cow 100 mg ANIMALS as gonadorelin acetate; gonadorelin by intramuscular injection, (2) 100 mg of gonadorelin as followed 6 to 8 days later by 500 mg ■ 21. The authority citation for 21 CFR gonadorelin acetate; cloprostenol by intramuscular injection, part 528 continues to read as follows: (3) 50 mg of gonadorelin as followed 30 to 72 hours later by 100 mg Authority: 21 U.S.C. 360b. gonadorelin diacetate tetrahydrate; or gonadorelin by intramuscular injection. (4) 50 mg of gonadorelin as (vi) For use with dinoprost injection § 528.1070 [Amended] gonadorelin hydrochloride. to synchronize estrous cycles to allow ■ 22. In § 528.1070, in paragraph (b), (b) Sponsors. See sponsor numbers in fixed-time artificial insemination (FTAI) remove ‘‘042976’’ and in its place add § 510.600(c) of this chapter. in lactating dairy cows: Administer to ‘‘086047’’. (1) No. 000061 for use of the 43-mg/ each cow 100 to 200 mg gonadorelin by mL product described in paragraph Dated: June 11, 2015. intramuscular injection, followed 6 to 8 (a)(1) as in paragraphs (d)(1)(i), days later by 25 mg dinoprost by Bernadette Dunham, (d)(1)(iv), and (d)(2) of this section. intramuscular injection, followed 30 to Director, Center for Veterinary Medicine. (2) No. 068504 for use of the 100-mg/ 72 hours later by 100 to 200 mg [FR Doc. 2015–14734 Filed 6–15–15; 8:45 am] mL product described in paragraph gonadorelin by intramuscular injection. BILLING CODE 4164–01–P (a)(2) as in paragraphs (d)(1)(ii), (2) Limitations. Federal law restricts (d)(1)(v), and (d)(2) of this section. this drug to use by or on the order of (3) Nos. 000859 and 050604 for use of a licensed veterinarian. DEPARTMENT OF THE TREASURY the 50-mg/mL product described in paragraph (a)(3) as in paragraphs § 522.1145 [Amended] Internal Revenue Service (d)(1)(ii) and (d)(2) of this section. ■ 16. In § 520.1145, in paragraph (4) No. 054771 for use of the 50-mg/ (e)(2)(i), remove ‘‘000859’’ and in its 26 CFR Parts 20, 25, and 602 mL product described in paragraph place add ‘‘050604’’. (a)(4) as in paragraphs (d)(1)(iii), [TD 9725] ■ 17. In § 522.2470, revise paragraph (b) (d)(1)(vi), and (d)(2) of this section. to read as follows: RIN 1545–BK74 (c) Special considerations. Concurrent luteolytic drug use is approved as § 522.2470 Tiletamine and zolazepam for Portability of a Deceased Spousal follows: injection. Unused Exclusion Amount (1) Cloprostenol injection for use as in * * * * * AGENCY: Internal Revenue Service (IRS), paragraph (d)(1)(iv) of this section as (b) Sponsors. See Nos. 026637 and Treasury. provided by No. 000061 in § 510.600(c) 054771 in § 510.600(c) of this chapter. of this chapter. ACTION: Final regulations and removal of * * * * * (2) Cloprostenol injection for use as in temporary regulations. ■ 18. In § 522.2483, revise paragraph (b) paragraph (d)(1)(v) of this section as to read as follows: SUMMARY: This document contains final provided by No. 000061 or No. 068504 regulations that provide guidance under in § 510.600(c) of this chapter. § 522.2483 Triamcinolone. sections 2010 and 2505 of the Internal (3) Dinoprost injection for use as in * * * * * Revenue Code on the estate and gift tax paragraph (d)(1)(vi) of this section as (b) Sponsors. See Nos. 000010 and applicable exclusion amount, in general, provided by No. 054771 in § 510.600(c) 054628 in § 510.600(c) of this chapter. as well as on the applicable of this chapter. * * * * * requirements for electing portability of a (d) Conditions of use in cattle—(1) deceased spousal unused exclusion Indications for use and amounts—(i) PART 526—INTRAMAMMARY DOSAGE (DSUE) amount to the surviving spouse For the treatment of ovarian follicular FORM NEW ANIMAL DRUGS and on the applicable rules for the cysts in dairy cattle: Administer 86 mg ■ 19. The authority citation for 21 CFR surviving spouse’s use of this DSUE gonadorelin by intramuscular or part 526 continues to read as follows: amount. The statutory provisions intravenous injection. (ii) For the treatment of ovarian underlying the portability rules were Authority: 21 U.S.C. 360b. enacted as part of the Tax Relief, follicular cysts in dairy cattle: ■ 20. In § 526.313, revise paragraph Unemployment Insurance Administer 100 mg gonadorelin by (d)(1)(ii) to read as follows: Reauthorization, and Job Creation Act of intramuscular or intravenous injection. (iii) For the treatment of ovarian 2010, and these provisions were made § 526.313 Ceftiofur. follicular cysts in cattle: Administer 100 permanent by the American Taxpayer * * * * * Relief Act of 2012. The portability rules mg gonadorelin by intramuscular (d) * * * injection. affect the estates of married decedents (1) * * * dying on or after January 1, 2011, and asabaliauskas on DSK5VPTVN1PROD with RULES (iv) For use with cloprostenol (ii) Indications for use. For use in injection to synchronize estrous cycles the surviving spouses of those lactating dairy cattle: to allow for fixed-time artificial decedents. (A) For the treatment of clinical insemination (FTAI) in lactating dairy mastitis associated with coagulase- DATES: cows: Administer to each cow 86 mg negative staphylococci, Streptococcus Effective Date. These regulations are gonadorelin by intramuscular injection, dysgalactiae, and Escherichia coli; and effective on June 12, 2015. followed 6 to 8 days later by 500 mg (B) For the treatment of diagnosed Applicability Dates: For specific dates cloprostenol by intramuscular injection, subclinical mastitis associated with of applicability of the final regulations, VerDate Sep<11>2014 16:14 Jun 15, 2015 Jkt 235001 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 E:\FR\FM\16JNR1.SGM 16JNR1


Document Created: 2018-02-22 10:23:10
Document Modified: 2018-02-22 10:23:10
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule; technical amendments.
DatesThis rule is effective June 16, 2015.
ContactGeorge K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected]
FR Citation80 FR 34276 
CFR Citation21 CFR 510
21 CFR 520
21 CFR 522
21 CFR 526
21 CFR 528
CFR AssociatedAdministrative Practice and Procedure; Animal Drugs; Labeling and Reporting and Recordkeeping Requirements
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