New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
Federal Register, Volume 83 Issue 62 (Friday, March 30, 2018)
Federal Register Volume 83, Number 62 (Friday, March 30, 2018)
Rules and Regulations
Pages 13632-13637
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2018-06358
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 556, and 558
Docket No. FDA-2017-N-0002
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
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SUMMARY: The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2017. FDA is 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 the withdrawal of approval of applications, changes of sponsorship of applications, and a change of a sponsor's name and address, and to make technical amendments to improve the accuracy of the regulations.
DATES: This rule is effective March 30, 2018, except for amendatory instructions 3 to 21 CFR 510.600, 9 to 21 CFR 522.300, 10 to 21 CFR 522.540, and 11 to 21 CFR 522.1081, which are effective April 9, 2018.
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:
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Approval Actions
FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during July, August, and September 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 (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 July, August, and September 2017
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Approval date File No. Sponsor Product name Species Effect of the action Public documents
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July 21, 2017........... 141-450 Intervet, Inc., 2 BANAMINE Transdermal Cattle.............. Original approval for FOI Summary; EA/
Giralda Farms, (flunixin transdermal the control of pyrexia FONSI.\1\
Madison, NJ 07940. solution) Solution. associated with bovine
respiratory disease
and the control of
pain associated with
foot rot in steers,
beef heifers, beef
cows, beef bulls
intended for
slaughter, and
replacement dairy
heifers under 20
months of age.
Page 13633
July 19, 2017........... 141-336 ECO LLC, 344 Nassau AIVLOSIN (tylvalosin Swine............... Supplemental approval FOI Summary.
St., Princeton, NJ tartrate) Water Soluble for control of swine
08540. Granules. respiratory disease
(SRD) associated with
Bordetella
bronchiseptica,
Haemophilus parasuis,
Pasteurella multocida,
and Streptococcus suis
in groups of swine in
buildings experiencing
an outbreak of SRD.
July 14, 2017........... 200-620 Aurora ALTREN (altrenogest) Horses.............. Original approval as a FOI Summary.
Pharmaceutical, Solution. generic copy of NADA
LLC, 1196 Highway 131-310.
3 South,
Northfield, MN
55057-3009.
July 14, 2017........... 200-621 Aurora SWINEMATE (altrenogest) Swine............... Original approval as a FOI Summary.
Pharmaceutical, Solution. generic copy of NADA
LLC, 1196 Highway 141-222.
3 South,
Northfield, MN
55057-3009.
September 15, 2017...... 141-250 Zoetis Inc., 333 Chlortetracycline and Cattle.............. Supplemental approval .....................
Portage St., lasalocid Type B and of revised
Kalamazoo, MI Type C medicated feeds. representative
49007. labeling making
technical amendments.
September 28, 2017...... 141-333 Virbac AH, Inc., SENTINEL SPECTRUM Dogs................ Supplemental approval FOI Summary.
3200 Meacham (milbemycin oxime/ for the treatment and
Blvd., Ft. Worth, lufenuron/praziquantel). control of the adult
TX 76137. tapeworm Dipylidium
caninum.
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\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
no significant impact (FONSI).
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Change of Sponsorship
SmartVet USA, Inc., 22201 West Innovation Dr., suite 170A, Olathe, KS 66061-1304 has informed FDA that it has transferred ownership of, and all rights and interest in, the following application to Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215:
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File No. Product name 21 CFR Section
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200-348........................ ECOMECTIN (ivermectin) 524.1193
Topical Solution.
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Following this withdrawal of approval, SmartVet USA, Inc. is no longer the sponsor of an approved application. Accordingly, it will be removed from the list of sponsors of approved applications in Sec. 510.600(c) (21 CFR 510.600(c)).
Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503 has informed FDA that it has transferred ownership of, and all rights and interest in, the following application to Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland:
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File No. Product name 21 CFR Section
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109-305........................ Oxytocin Injection.... 522.1680
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The animal drug regulations are being amended to reflect these changes of sponsorship.
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Withdrawals of Approval
The following sponsors requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed:
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File No. Sponsor Product name 21 CFR Section
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047-055............................. Watson Laboratories, Inc., Chorionic Gonadotropin 522.1081
311 Bonnie Circle, Corona, Powder for Injection.
CA 92880.
104-606............................. Watson Laboratories, Inc., Dexamethasone Sodium 522.540
311 Bonnie Circle, Corona, Phosphate Injection.
CA 92880.
Page 13634
139-633............................. Wildlife Laboratories, Inc., WILDNIL (carfentanil 522.300
1230 W. Ash St., Suite D, citrate) Injection.
Windsor, CO 80550.
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Following this withdrawal of approval, Watson Laboratories, Inc. is no longer the sponsor of an approved application. Accordingly, it will be removed from the list of sponsors of approved applications in Sec. 510.600(c).
Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADAs 047-055, 104-606, and 139-633, and all supplements and amendments thereto, is withdrawn, effective April 9, 2018. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions.
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Technical Amendments
Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA 98248 has informed FDA that it has changed its name and address to Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248. ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115 has informed FDA that it has changed its name to ADM Animal Nutrition, Inc. Accordingly, we are amending Sec. 510.600(c) to reflect these changes.
We are also making technical amendments to update the scientific name of a pathogenic bacterium, to accurately list the concentrations of ingredients in a combination new animal drug, and to correctly list the assay limits and maximum drug concentration in Type B medicated feeds for a combination new animal drug used in feed. These actions are being taken to improve the accuracy of the regulations.
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Legal Authority
This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.360b(i)), which requires Federal Register publication of ``notices . . . 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
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, and 524
Animal drugs.
21 CFR Part 556
Animal drugs, Food.
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, 21 CFR parts 510, 520, 522, 524, 556, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 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 entries for ``ADM Alliance Nutrition, Inc.'', ``SmartVet USA, Inc.'' and ``Western Chemical, Inc.'', and add entries for ``ADM Animal Nutrition, Inc.'' and ``Syndel USA'' in alphabetical order; and in the table in paragraph (c)(2), remove the entry for ``086001'' and revise the entries for ``012286'' and ``050378'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.
* * * * *
(c) * * *
(1) * * *
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Drug labeler
Firm name and address code
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* * * * * * *
ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, 012286
IL 62305-3115..........................................
* * * * * * *
Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248....... 050378
* * * * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * * * *
012286..................................... ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115.
Page 13635
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050378..................................... Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248.
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0
3. Effective April 9, 2018,'' in Sec. 510.600, in the table in paragraph (c)(1), remove the entry for ``Watson Laboratories, Inc.''; and in the table in paragraph (c)(2), remove the entry for ``000402''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
4. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.48 Amended
0
5. In Sec. 520.48, in paragraph (b), remove ``000061 and 061623'' and in its place add ``000061, 051072, and 061623''.
Sec. 520.1447 Amended
0
6. In Sec. 520.1447, in paragraph (d)(1)(ii), remove ``(Taenia pisiformis, Echinococcus multilocularis, and E. granulosus)'' and in its place add ``(Dipylidium caninum, Taenia pisiformis, Echinococcus multilocularis, and E. granulosus)''.
0
7. In Sec. 520.2645, revise paragraphs (d)(1) and (2) to read as follows:
Sec. 520.2645 Tylvalosin.
* * * * *
(d) * * *
(1) Amount. Administer 50 parts per million (ppm) tylvalosin continuously in drinking water for 5 consecutive days.
(2) Indications for use. For control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine in buildings experiencing an outbreak of PPE; and for control of swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Haemophilus parasuis, Pasteurella multocida, and Streptococcus suis in groups of swine in buildings experiencing an outbreak of SRD.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
8. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.300 Removed
0
9. Effective April 9, 2018, remove Sec. 522.300.
0
10. Effective April 9, 2018, in Sec. 522.540, revise paragraphs (b)(2) and (c)(2) to read as follows:
Sec. 522.540 Dexamethasone solution.
* * * * *
(b) * * *
(2) Sponsor. See No. 061623 in Sec. 510.600(c) of this chapter.
* * * * *
(c) * * *
(2) Sponsor. See No. 061623 in Sec. 510.600(c) of this chapter.
* * * * *
Sec. 522.1081 Amended
0
11. Effective April 9, 2018, in Sec. 522.1081, in paragraph (b)(1), remove ``Nos. 000402 and 054771'' and in its place add ``No. 054771''.
Sec. 522.1662a Amended
0
12. In Sec. 522.1662a, in paragraph (h)(3)(ii), remove ``Spherophorus necrophorus'' and in its place add ``Fusobacterium necrophorum''.
Sec. 522.1680 Amended
0
13. In Sec. 522.1680, in paragraph (b), remove ``054628,''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
14. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
15. Add Sec. 524.970 to read as follows:
Sec. 524.970 Flunixin.
(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) flunixin (equivalent to 83 mg flunixin meglumine).
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.286 of this chapter.
(d) Conditions of use--(1) Amount. Apply only once at a dose of 3.3 mg flunixin per kg body weight (1.5 mg/lb; 3 mL per 100 lbs) topically in a narrow strip along the dorsal midline from the withers to the tailhead.
(2) Indications for use. For the control of pyrexia associated with bovine respiratory disease and the control of pain associated with foot rot in steers, beef heifers, beef cows, beef bulls intended for slaughter, and replacement dairy heifers under 20 months of age.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Cattle must not be slaughtered for human consumption within 8 days of the last treatment. Not for use in female dairy cattle 20 months of age or older, including dry dairy cows; use in these cattle may cause drug residues in milk and/or in calves born to these cows or heifers. Not for use in suckling beef calves, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves.
0
16. In Sec. 524.1132, revise paragraph (a) to read as follows:
Sec. 524.1132 Hydrocortisone, miconazole, and gentamicin otic suspension.
(a) Specifications. Each milliliter (mL) of suspension contains 1.11 milligrams (mg) hydrocortisone aceponate, 17.4 mg miconazole nitrate, and 1.5 mg gentamicin (as gentamicin sulfate).
* * * * *
Sec. 524.1193 Amended
0
17. In Sec. 524.1193, in paragraph (b)(2), remove ``086001'' and in its place add ``058005''.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
18. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
Sec. 556.286 Amended
0
19. In Sec. 556.286, in paragraph (c), remove ``Sec. Sec. 522.956 and 522.970'' and in its place add ``Sec. Sec. 522.956, 522.970, and 524.970''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
20. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
21. In Sec. 558.4, in paragraph (d), in the ``Category II'' table, revise the row entries for ``Neomycin'' through ``Pyrantel tartrate'' to read as follows:
Page 13636
Sec. 558.4 Requirement of a medicated feed mill license.
* * * * *
(d) * * *
Category II
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Assay limits Assay limits
Drug percent \1\ Type B maximum (100x) percent \1\ Type
Type A \1\ B/C \2\
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Neomycin.................................... 80-120 20 g/lb (4.4%)................. 70-125
Oxytetracycline............................. 80-120 20 g/lb (4.4%)................. 65-135
Neomycin sulfate............................ 80-120 100 g/lb (22.0%)............... 70-125
Nicarbazin (granular)....................... 90-110 5.675 g/lb (1.25%)............. 85-115/75-125
Narasin..................................... 90-110 5.675 g/lb (1.25%)............. 85-115/75-125
Nicarbazin (powder)......................... 98-106 5.675 g/lb (1.25%)............. 85-115/80-120
Novobiocin.................................. 85-115 17.5 g/lb (3.85%).............. 80-120
Pyrantel tartrate........................... 90-110 36 g/lb (7.9%)................. 75-125
* * * * * * *
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\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
range limits, 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.
* * * * *
0
22. In Sec. 558.128, revise paragraphs (e)(3)(vi), (e)(4)(ix), and (e)(4)(xxvi) to read as follows:
Sec. 558.128 Chlortetracycline.
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(e) * * *
(3) * * *
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Combination in
Chlortetracycline amount grams/ton Indications for use Limitations Sponsor
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* * * * * * *
(vi) 10 mg/lb of body weight... Tiamulin hydrogen For control of swine Feed chlortetracycline 058198
fumarate, 35. dysentery associated at approximately 400 069254
with Brachyspira g/ton of feed,
(formerly Serpulina varying with body
or Treponema) weight and food
hyodysenteriae consumption, to
susceptible to provide 10 mg/lb of
tiamulin and for body weight. Feed
treatment of swine continuously as the
bacterial enteritis sole ration for 14
caused by E. coli and days. Withdraw
Salmonella medicated feed 2 days
choleraesuis before slaughter.
sensitive to Tiamulin as provided
chlortetracycline and by Nos. 058198 or
treatment of 069254 in Sec.
bacterial pneumonia 510.600(c) of this
caused by P. chapter.
multocida sensitive
to chlortetracycline.
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(4) * * *
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Combination in
Chlortetracycline amount grams/ton Indications for use Limitations Sponsor
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Page 13637
* * * * * * *
(ix) 500 to 4,000 to provide 10 Lasalocid, 30 to Pasture cattle Feed continuously on a 054771
mg/lb of body weight daily. 600. (slaughter, stocker, hand-fed basis for
feeder cattle, dairy not more than 5 days
and beef replacement to provide 10 mg
heifers): For chlortetracycline per
treatment of lb. body weight per
bacterial enteritis day and not less than
caused by E. coli and 60 mg or more than
bacterial pneumonia 300 mg lasalocid per
caused by P. head per day in at
multocida organisms least 1 pound of
susceptible to feed. Daily lasalocid
chlortetracycline; intakes in excess of
and for increased 200 mg/head/day in
rate of weight gain. pasture cattle have
not been shown to be
more effective than
200 mg lasalocid/head/
day. Do not allow
horses or other
equines access to
feeds containing
lasalocid. No
withdrawal period is
required. A
withdrawal period has
not been established
for this product in
pre-ruminating
calves. Do not use in
calves to be
processed for veal.
See Sec. 558.311(d)
of this chapter.
Lasalocid as provided
by No. 054771 in Sec.
510.600(c) of this
chapter.
* * * * * * *
(xxvi) 500 to 4,000 to provide Lasalocid, 30 to Cattle weighing up to Hand feed continuously 054771
10 mg/head/day. 181.8. 800 pounds: For the for not more than 5
treatment of days at a rate of 10
bacterial enteritis mg chlortetracycline
caused by E. coli and and 1 mg lasalocid
bacterial pneumonia per 2.2 lb. body
caused by P. weight daily to
multocida susceptible cattle with a maximum
to chlortetracycline; of 360 mg of
and for the control lasalocid per head
of coccidiosis caused per day. Do not allow
by Eimeria bovis and horses or other
E. zuernii. equines access to
feeds containing
lasalocid. No
withdrawal period is
required. A
withdrawal period has
not been established
for this product in
pre-ruminating
calves. Do not use in
calves to be
processed for veal.
See Sec. 558.311(d)
of this chapter.
Lasalocid as provided
by No. 054771 in Sec.
510.600(c) of this
chapter.
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* * * * *
0
23. In Sec. 558.325, revise paragraph (d)(2) to read as follows:
Sec. 558.325 Lincomycin.
* * * * *
(d) * * *
(2) The expiration date of VFDs for lincomycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for lincomycin shall not be refilled.
* * * * *
Sec. 558.575 Amended
0
24. In Sec. 558.575, in paragraph (e)(2)(ii) remove ``and bacterial infections due to H. galmaxima,''.
Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
FR Doc. 2018-06358 Filed 3-29-18; 8:45 am
BILLING CODE 4164-01-P
