[Federal Register Volume 80, Number 115 (Tuesday, June 16, 2015)]
[Rules and Regulations]
[Pages 34276-34279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14734]
-----------------------------------------------------------------------
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