82 FR 58554 - New Animal Drugs; Approval of New Animal Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 238 (December 13, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 238 (December 13, 2017)
| Page Range | 58554-58557 | |
| FR Document | 2017-26753 |
[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)] [Rules and Regulations] [Pages 58554-58557] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26753] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 529, and 558 [Docket No. FDA-2017-N-0002] New Animal Drugs; Approval of New Animal Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during May and June 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 make technical amendments to improve the accuracy of the regulations. DATES: This rule is effective December 13, 2017. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected]. SUPPLEMENTARY INFORMATION: I. Approval Actions FDA is amending the animal drug regulations to reflect approval actions for a NADA and ANADAs during May and June 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 May and June 2017 -------------------------------------------------------------------------------------------------------------------------------------------------------- Effect of the Approval date File No. Sponsor Product name Species action Public documents -------------------------------------------------------------------------------------------------------------------------------------------------------- May 23, 2017.............. 055-099 Zoetis Inc., 333 CLAVAMOX Dogs and cats........... Supplemental FOI Summary. Portage St., (amoxicillin and approval of a Kalamazoo, MI clavulanate chewable tablet 49007. potassium tablets) form of the Chewables. approved tablet. June 21, 2017............. 141-338 Elanco US Inc., INTERCEPTOR Dogs.................... Supplemental FOI Summary. 2500 Innovation SPECTRUM approval for the Way, Greenfield, (milbemycin oxime/ treatment and IN 46140. praziquantel) control of adult Chewable Tablets. tapeworm (Dipylidium caninum) infections in dogs and puppies 2 pounds of body weight or greater and 6 weeks of age and older. [[Page 58555]] May 25, 2017.............. 200-610 Modern Veterinary Medetomidine HCl Dogs.................... Original approval FOI Summary. Therapeutics, LLC, (medetomidine as a generic copy 14343 SW 119th hydrochloride) of NADA 140-999. Ave., Miami, FL Injectable 33186. Solution. June 23, 2017............. 200-618 Virbac AH, Inc., ZOLETIL (tiletamine Dogs and cats........... Original approval FOI Summary. 3200 Meacham HCl and zolazepam as a generic copy Blvd., Ft. Worth, HCl) for Injection. of NADA 106-111. TX 76137. -------------------------------------------------------------------------------------------------------------------------------------------------------- Following the approval of ANADA 200-610, Modern Veterinary Therapeutics, LLC, will now be included in the lists of sponsors of approved applications in Sec. 510.600(c) (21 CFR 510.600(c)). II. Technical Amendments We are making several technical amendments in 21 CFR part 558, which was amended on December 27, 2016 (81 FR 94991), and February 24, 2017 (82 FR 11510), as part of the FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. We are also making several technical amendments to the regulations for dosage form drugs to reflect revised labeling. These actions are being taken to improve the accuracy of the regulations. III. Legal Authority This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(i)), which requires Federal Register publication of ``notice[s] . . . effective as a regulation,'' of the conditions of use of approved new animal drugs. This rule sets forth technical amendments to the regulations to codify recent actions on approved new animal drug applications and corrections to improve the accuracy of the regulations, and as such does not impose any burden on regulated entities. Although denominated a rule pursuant to the FD&C Act, this document does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because it is a ``rule of particular applicability.'' Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive Order 12866, which defines a rule as ``an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.'' List of Subjects 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Parts 520, 522, 524, 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, 21 CFR parts 510, 520, 522, 524, 529, 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), alphabetically add an entry for ``Modern Veterinary Therapeutics, LLC''; and in the table in paragraph (c)(2), numerically add an entry for ``015914.'' The additions 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 ------------------------------------------------------------------------ * * * * * * * Modern Veterinary Therapeutics, LLC, 14343 SW 119th 015914 Ave., Miami, FL 33186................................. * * * * * * * ------------------------------------------------------------------------ (2) * * * ------------------------------------------------------------------------ Drug labeler code Firm name and address ------------------------------------------------------------------------ * * * * * * * 015914.................. Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186. * * * * * * * ------------------------------------------------------------------------ [[Page 58556]] PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 0 3. The authority citation for part 520 continues to read as follows: Authority: 21 U.S.C. 360b. 0 4. In Sec. 520.88g, revise the section heading and paragraphs (a) and (b) to read as follows: Sec. 520.88g Amoxicillin trihydrate and clavulanate potassium tablets. (a) Specifications. Each tablet or chewable tablet contains amoxicillin trihydrate and clavulanate potassium equivalent to 50 milligrams (mg) of amoxicillin and 12.5 mg clavulanic acid, 100 mg of amoxicillin and 25 mg clavulanic acid, 200 mg amoxicillin and 50 mg clavulanic acid, or 300 mg amoxicillin and 75 mg clavulanic acid. (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter: (1) No. 054771 for use of tablets and chewable tablets as in paragraph (c) of this section. (2) No. 026637 for use of tablets as in paragraph (c) of this section. * * * * * 0 5. In Sec. 520.1445, revise paragraph (c)(1)(ii) to read as follows: Sec. 520.1445 Milbemycin oxime and praziquantel. * * * * * (c) * * * (1) * * * (ii) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm (Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult tapeworm (Taenia pisiformis, Echinococcus multilocularis, E. granulosus, and Dipylidium caninum) infections in dogs and puppies 2 pounds of body weight or greater and 6 weeks of age and older. * * * * * PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 6. The authority citation for part 522 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 522.1335 [Amended] 0 7. In Sec. 522.1335, in paragraph (b), remove ``052483'' and in its place add ``Nos. 015914 and 052483''. 0 8. In Sec. 522.2470, revise paragraphs (b), (c)(1)(i) and (ii), and (c)(2) to read as follows: Sec. 522.2470 Tiletamine and zolazepam for injection. * * * * * (b) Sponsors. See Nos. 026637, 051311, and 054771 in Sec. 510.600(c) of this chapter. (c) * * * (1) * * * (i) Healthy dogs. An initial intramuscular dosage of 3 to 4.5 milligrams per pound (mg/lb) of body weight for diagnostic purposes; 4.5 to 6 mg/lb of body weight for minor procedures of short duration such as repair of lacerations and wounds, castrations, and other procedures requiring mild to moderate analgesia. Supplemental doses when required should be less than the initial dose and the total dose given should not exceed 12 mg/lb of body weight. The maximum total safe dose is 13.6 mg/lb of body weight. (ii) Healthy cats. An initial intramuscular dosage of 4.4 to 5.4 mg/lb of body weight is recommended for such procedures as dentistry, treatment of abscesses, foreign body removal, and related types of surgery; 4.8 to 5.7 mg/lb of body weight for minor procedures requiring mild to moderate analgesia, such as repair of lacerations, castrations, and other procedures of short duration. Initial dosages of 6.5 to 7.2 mg/lb of body weight are recommended for ovariohysterectomy and onychectomy. When supplemental doses are required, such individual supplemental doses should be given in increments that are less than the initial dose, and the total dose given (initial dose plus supplemental doses) should not exceed the maximum allowable safe dose of 32.7 mg/lb of body weight. (2) Indications for use. For restraint or for anesthesia combined with muscle relaxation in cats and in dogs for restraint and minor procedures of short duration (30 minutes average) requiring mild to moderate analgesia. * * * * * PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0 9. The authority citation for part 524 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 524.1580a [Amended] 0 10. In Sec. 524.1580a, in paragraph (d)(3), in the second sentence, remove ``in'' and in its place add ``on''. PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 0 11. The authority citation for part 529 continues to read as follows: Authority: 21 U.S.C. 360b. 0 12. Amend 529.1030 as follows: 0 a. Revise paragraph (d)(1)(ii); 0 b. In the table in paragraph (d)(2)(i), revise footnote 1; 0 c. In paragraph (d)(2)(ii), in the table, in the heading of the ``Administer in earthen ponds indefinitely ([mu]L/L or ppm)'' column, remove ``indefinitely'' and in its place add ``single treatment''; and 0 d. Revise paragraphs (d)(2)(iii) and (d)(3). The revisions read as follows: Sec. 529.1030 Formalin. * * * * * (d) * * * (1) * * * (ii) All finfish. For control of external protozoa Ichthyophthirius spp., Chilodonella spp., Ichthyobodo spp., Ambiphrya spp., Epistylis spp., and Trichodina spp., and the monogeneans Cleidodiscus spp., Gyrodactylus spp., and Dactylogyrus spp. * * * * * (2) * * * (i) * * * \1\ Treat for up to 4 hours daily. Treatment may be repeated daily until parasite control is achieved. Use the lower concentration when tanks or raceways are heavily loaded with phytoplankton or shrimp, to avoid oxygen depletion due to the biological oxygen demand created by decay of dead phytoplankton. Alternatively, a higher concentration might be used if dissolved oxygen is strictly monitored. * * * * * (iii) For control of fungi of the family Saprolegniaceae on finfish eggs: Eggs of all finfish except Acipenseriformes, 1,000 to 2,000 [mu]L/L (ppm) for 15 minutes; eggs of Acipenseriformes, up to 1,500 [mu]L/L (ppm) for 15 minutes. A preliminary bioassay should be conducted on a small subsample of fish eggs to determine sensitivity before treating an entire group. This is necessary for all species because egg sensitivity can vary with species or strain and the unique conditions at each facility. (3) Limitations. Fish tanks and raceways may be treated daily until parasite control is achieved. Pond treatment may be repeated in 5 to 10 days if needed. However, pond treatments for Ichthyophthirius spp. should be made at 2-day intervals until control is achieved. Egg tanks may be [[Page 58557]] treated as often as necessary to prevent growth of fungi. Do not use formalin which has been subjected to temperatures below 40 [deg]F, or allowed to freeze. Treatments in tanks and raceways should never exceed 1 hour for fish or 4 hours for penaeid shrimp (even if they show no sign of distress), nor should it exceed 15 minutes for fish eggs. Do not apply formalin to ponds with water warmer than 27 [deg]C (80 [deg]F), when a heavy bloom of phytoplankton is present, or when the concentration of dissolved oxygen is less than 5 milligrams per liter. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 13. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. Sec. 558.58 [Amended] 0 14. In Sec. 558.58, remove paragraphs (f)(4) and (5). Sec. 558.366 [Amended] 0 15. In Sec. 558.366, remove paragraph (e). Dated: December 5, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-26753 Filed 12-12-17; 8:45 am] BILLING CODE 4164-01-P
![58554 Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Rules and Regulations
Drugs and other appropriate officials on Therefore, under the Federal Food, of the availability of summaries of the
emerging food and cosmetic safety, food Drug, and Cosmetic Act and under basis of approval and of environmental
science, nutrition, and other food- authority delegated to the Commissioner review documents, where applicable.
related health issues that FDA considers of Food and Drugs, 21 CFR part 14 is The animal drug regulations are also
of primary importance for its food and amended as follows: being amended to make technical
cosmetics programs. The Committee amendments to improve the accuracy of
may also be asked to provide advice and PART 14—PUBLIC HEARING BEFORE the regulations.
make recommendations on ways of A PUBLIC ADVISORY COMMITTEE
DATES: This rule is effective December
communicating to the public the
■ 1. The authority citation for part 14 13, 2017.
potential risks associated with these
issues and on approaches that might be continues to read as follows: FOR FURTHER INFORMATION CONTACT:
considered for addressing the issues. Authority: 5 U.S.C. App. 2; 15 U.S.C 1451– George K. Haibel, Center for Veterinary
The Committee is no longer needed 1461, 21 U.S.C. 41–50, 141–149, 321–394, Medicine (HFV–6), Food and Drug
and will be terminated on December 12, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 Administration, 7500 Standish Pl.,
2017. Over the past several years, the U.S.C. 201, 262, 263b, 264; Pub. L. 107–109; Rockville, MD 20855, 240–402–5689,
Committee has met very infrequently, Pub. L. 108–155; Pub. L. 113–54. george.haibel@fda.hhs.gov.
and the effort and expense of § 14.100 [Amended] SUPPLEMENTARY INFORMATION:
maintaining the Committee are no
longer justified. Any relevant food ■ 2. Section 14.100 is amended by I. Approval Actions
issues in the future could be addressed removing paragraph (f).
Dated: December 7, 2017.
FDA is amending the animal drug
by FDA’s Science Board and/or FDA’s
regulations to reflect approval actions
Risk Communication Advisory Leslie Kux,
for a NADA and ANADAs during May
Committee, with additional Associate Commissioner for Policy. and June 2017, as listed in table 1. In
augmentation of expertise by [FR Doc. 2017–26829 Filed 12–12–17; 8:45 am] addition, FDA is informing the public of
appropriate subject matter experts BILLING CODE 4164–01–P the availability, where applicable, of
serving as temporary members on either
of those committees. In addition, documentation of environmental review
CFSAN will continue to hold required under the National
DEPARTMENT OF HEALTH AND Environmental Policy Act (NEPA) and,
workshops, meetings, conferences, and HUMAN SERVICES
webinars to engage with its for actions requiring review of safety or
stakeholders. effectiveness data, summaries of the
Food and Drug Administration
Under 5 U.S.C. 553(b)(3)(B) and (d) basis of approval (FOI Summaries)
and 21 CFR 10.40(d) and (e), the Agency under the Freedom of Information Act
21 CFR Parts 510, 520, 522, 524, 529,
finds good cause to dispense with notice (FOIA). These public documents may be
and 558
and public comment procedures and to seen in the Dockets Management Staff
proceed to an immediate effective date [Docket No. FDA–2017–N–0002] (HFA–305), Food and Drug
on this rule. Notice and public comment Administration, 5630 Fishers Lane, Rm.
New Animal Drugs; Approval of New 1061, Rockville, MD 20852, between 9
and a delayed effective date are Animal Drug Applications
unnecessary because the Committee is a.m. and 4 p.m., Monday through
not being adequately used, and the final AGENCY: Food and Drug Administration, Friday. Persons with access to the
rule merely removes the name of the HHS. internet may obtain these documents at
Food Advisory Committee from the list Final rule; technical
ACTION: the CVM FOIA Electronic Reading
of standing advisory committees in amendments. Room: https://www.fda.gov/AboutFDA/
§ 14.100 (21 CFR 14.100). CentersOffices/OfficeofFoods/CVM/
Therefore, the Agency is amending SUMMARY: The Food and Drug CVMFOIAElectronicReadingRoom/
§ 14.100(f) as set forth in the regulatory Administration (FDA or we) is default.htm. Marketing exclusivity and
text of the document. amending the animal drug regulations to patent information may be accessed in
reflect application-related actions for a FDA’s publication, Approved Animal
List of Subjects in 21 CFR Part 14 new animal drug application (NADA) Drug Products Online (Green Book) at:
Administrative practice and and abbreviated new animal drug https://www.fda.gov/AnimalVeterinary/
procedure, Advisory committee, Color applications (ANADAs) during May and Products/ApprovedAnimalDrug
additives, Drugs, Radiation protection. June 2017. FDA is informing the public Products/default.htm.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MAY AND JUNE 2017
Public
Approval date File No. Sponsor Product name Species Effect of the action documents
May 23, 2017 ............ 055–099 Zoetis Inc., 333 Portage CLAVAMOX (amoxicillin Dogs and cats ...... Supplemental approval of FOI Summary.
St., Kalamazoo, MI and clavulanate potas- a chewable tablet form
49007. sium tablets) Chewables. of the approved tablet.
June 21, 2017 ........... 141–338 Elanco US Inc., 2500 In- INTERCEPTOR SPEC- Dogs ..................... Supplemental approval for FOI Summary.
novation Way, Green- TRUM (milbemycin the treatment and con-
field, IN 46140. oxime/ praziquantel) trol of adult tapeworm
sradovich on DSK3GMQ082PROD with RULES
Chewable Tablets. (Dipylidium caninum) in-
fections in dogs and
puppies 2 pounds of
body weight or greater
and 6 weeks of age and
older.
VerDate Sep<11>2014 15:49 Dec 12, 2017 Jkt 244001 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 E:\FR\FM\13DER1.SGM 13DER1](https://thefederalregister.org/doc/82_FR_58792/page/1.svg)
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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MAY AND JUNE 2017—Continued
Public
Approval date File No. Sponsor Product name Species Effect of the action documents
May 25, 2017 ............ 200–610 Modern Veterinary Thera- Medetomidine HCl Dogs ..................... Original approval as a ge- FOI Summary.
peutics, LLC, 14343 SW (medetomidine hydro- neric copy of NADA
119th Ave., Miami, FL chloride) Injectable So- 140–999.
33186. lution.
June 23, 2017 ........... 200–618 Virbac AH, Inc., 3200 ZOLETIL (tiletamine HCl Dogs and cats ...... Original approval as a ge- FOI Summary.
Meacham Blvd., Ft. and zolazepam HCl) for neric copy of NADA
Worth, TX 76137. Injection. 106–111.
Following the approval of ANADA new animal drug applications and 21 CFR Part 558
200–610, Modern Veterinary corrections to improve the accuracy of
Therapeutics, LLC, will now be the regulations, and as such does not Animal drugs, Animal feeds.
included in the lists of sponsors of impose any burden on regulated Therefore, under the Federal Food,
approved applications in § 510.600(c) entities. Drug, and Cosmetic Act and under
(21 CFR 510.600(c)). Although denominated a rule authority delegated to the Commissioner
pursuant to the FD&C Act, this
II. Technical Amendments of Food and Drugs, 21 CFR parts 510,
document does not meet the definition
520, 522, 524, 529, and 558 are
We are making several technical of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
amended as follows:
amendments in 21 CFR part 558, which it is a ‘‘rule of particular applicability.’’
was amended on December 27, 2016 (81 Therefore, it is not subject to the PART 510—NEW ANIMAL DRUGS
FR 94991), and February 24, 2017 (82 congressional review requirements in 5
FR 11510), as part of the FDA Center for U.S.C. 801–808. Likewise, this is not a
rule subject to Executive Order 12866, ■ 1. The authority citation for part 510
Veterinary Medicine’s (CVM’s)
which defines a rule as ‘‘an agency continues to read as follows:
Judicious Use Initiative. We are also
making several technical amendments statement of general applicability and Authority: 21 U.S.C. 321, 331, 351, 352,
to the regulations for dosage form drugs future effect, which the agency intends 353, 360b, 371, 379e.
to reflect revised labeling. These actions to have the force and effect of law, that
■ 2. In § 510.600, in the table in
are being taken to improve the accuracy is designed to implement, interpret, or
paragraph (c)(1), alphabetically add an
of the regulations. prescribe law or policy or to describe
the procedure or practice requirements entry for ‘‘Modern Veterinary
III. Legal Authority of an agency.’’ Therapeutics, LLC’’; and in the table in
paragraph (c)(2), numerically add an
This final rule is issued under section List of Subjects entry for ‘‘015914.’’ The additions read
512(i) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 21 CFR Part 510 as follows:
360b(i)), which requires Federal Administrative practice and § 510.600 Names, addresses, and drug
Register publication of ‘‘notice[s] . . . procedure, Animal drugs, Labeling, labeler codes of sponsors of approved
effective as a regulation,’’ of the Reporting and recordkeeping applications.
conditions of use of approved new requirements. * * * * *
animal drugs. This rule sets forth
technical amendments to the regulations 21 CFR Parts 520, 522, 524, and 529 (c) * * *
to codify recent actions on approved Animal drugs. (1) * * *
Drug
Firm name and address labeler code
* * * * * * *
Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186 ............................................................................. 015914
* * * * * * *
(2) * * *
Drug labeler Firm name and address
code
* * * * * * *
015914 ............ Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186.
sradovich on DSK3GMQ082PROD with RULES
* * * * * * *
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![58556 Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Rules and Regulations
PART 520—ORAL DOSAGE FORM § 522.2470 Tiletamine and zolazepam for PART 529—CERTAIN OTHER DOSAGE
NEW ANIMAL DRUGS injection. FORM NEW ANIMAL DRUGS
* * * * *
■ 3. The authority citation for part 520 ■ 11. The authority citation for part 529
(b) Sponsors. See Nos. 026637, continues to read as follows:
continues to read as follows:
051311, and 054771 in § 510.600(c) of
Authority: 21 U.S.C. 360b. this chapter. Authority: 21 U.S.C. 360b.
■ 4. In § 520.88g, revise the section (c) * * * ■ 12. Amend 529.1030 as follows:
heading and paragraphs (a) and (b) to ■ a. Revise paragraph (d)(1)(ii);
(1) * * * ■ b. In the table in paragraph (d)(2)(i),
read as follows:
(i) Healthy dogs. An initial revise footnote 1;
§ 520.88g Amoxicillin trihydrate and intramuscular dosage of 3 to 4.5 ■ c. In paragraph (d)(2)(ii), in the table,
clavulanate potassium tablets. milligrams per pound (mg/lb) of body in the heading of the ‘‘Administer in
(a) Specifications. Each tablet or weight for diagnostic purposes; 4.5 to 6 earthen ponds indefinitely (mL/L or
chewable tablet contains amoxicillin mg/lb of body weight for minor ppm)’’ column, remove ‘‘indefinitely’’
trihydrate and clavulanate potassium procedures of short duration such as and in its place add ‘‘single treatment’’;
equivalent to 50 milligrams (mg) of repair of lacerations and wounds, and
amoxicillin and 12.5 mg clavulanic castrations, and other procedures ■ d. Revise paragraphs (d)(2)(iii) and
acid, 100 mg of amoxicillin and 25 mg requiring mild to moderate analgesia. (d)(3).
clavulanic acid, 200 mg amoxicillin and Supplemental doses when required The revisions read as follows:
50 mg clavulanic acid, or 300 mg should be less than the initial dose and § 529.1030 Formalin.
amoxicillin and 75 mg clavulanic acid. the total dose given should not exceed * * * * *
(b) Sponsors. See sponsors in 12 mg/lb of body weight. The maximum (d) * * *
§ 510.600(c) of this chapter: total safe dose is 13.6 mg/lb of body (1) * * *
(1) No. 054771 for use of tablets and weight. (ii) All finfish. For control of external
chewable tablets as in paragraph (c) of protozoa Ichthyophthirius spp.,
(ii) Healthy cats. An initial
this section. Chilodonella spp., Ichthyobodo spp.,
intramuscular dosage of 4.4 to 5.4 mg/
(2) No. 026637 for use of tablets as in Ambiphrya spp., Epistylis spp., and
lb of body weight is recommended for
paragraph (c) of this section. Trichodina spp., and the monogeneans
such procedures as dentistry, treatment
* * * * * of abscesses, foreign body removal, and Cleidodiscus spp., Gyrodactylus spp.,
■ 5. In § 520.1445, revise paragraph related types of surgery; 4.8 to 5.7 mg/ and Dactylogyrus spp.
(c)(1)(ii) to read as follows: lb of body weight for minor procedures * * * * *
requiring mild to moderate analgesia, (2) * * *
§ 520.1445 Milbemycin oxime and
praziquantel. such as repair of lacerations, castrations, (i) * * *
1 Treat for up to 4 hours daily.
and other procedures of short duration.
* * * * * Treatment may be repeated daily until
Initial dosages of 6.5 to 7.2 mg/lb of
(c) * * * parasite control is achieved. Use the
body weight are recommended for
(1) * * * lower concentration when tanks or
ovariohysterectomy and onychectomy.
(ii) Indications for use. For the raceways are heavily loaded with
When supplemental doses are required,
prevention of heartworm disease caused phytoplankton or shrimp, to avoid
such individual supplemental doses
by Dirofilaria immitis and for the oxygen depletion due to the biological
should be given in increments that are
treatment and control of adult oxygen demand created by decay of
less than the initial dose, and the total
roundworm (Toxocara canis, Toxascaris dead phytoplankton. Alternatively, a
leonina), adult hookworm (Ancylostoma dose given (initial dose plus higher concentration might be used if
caninum), adult whipworm (Trichuris supplemental doses) should not exceed
the maximum allowable safe dose of dissolved oxygen is strictly monitored.
vulpis), and adult tapeworm (Taenia * * * * *
pisiformis, Echinococcus multilocularis, 32.7 mg/lb of body weight. (iii) For control of fungi of the family
E. granulosus, and Dipylidium caninum) (2) Indications for use. For restraint or
Saprolegniaceae on finfish eggs: Eggs of
infections in dogs and puppies 2 for anesthesia combined with muscle
all finfish except Acipenseriformes,
pounds of body weight or greater and 6 relaxation in cats and in dogs for 1,000 to 2,000 mL/L (ppm) for 15
weeks of age and older. restraint and minor procedures of short minutes; eggs of Acipenseriformes, up
* * * * * duration (30 minutes average) requiring to 1,500 mL/L (ppm) for 15 minutes. A
mild to moderate analgesia. preliminary bioassay should be
PART 522—IMPLANTATION OR * * * * * conducted on a small subsample of fish
INJECTABLE DOSAGE FORM NEW eggs to determine sensitivity before
ANIMAL DRUGS PART 524—OPHTHALMIC AND treating an entire group. This is
TOPICAL DOSAGE FORM NEW necessary for all species because egg
■ 6. The authority citation for part 522
ANIMAL DRUGS sensitivity can vary with species or
continues to read as follows:
strain and the unique conditions at each
Authority: 21 U.S.C. 360b. ■ 9. The authority citation for part 524 facility.
§ 522.1335 [Amended] continues to read as follows: (3) Limitations. Fish tanks and
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Authority: 21 U.S.C. 360b. raceways may be treated daily until
■ 7. In § 522.1335, in paragraph (b), parasite control is achieved. Pond
remove ‘‘052483’’ and in its place add treatment may be repeated in 5 to 10
§ 524.1580a [Amended]
‘‘Nos. 015914 and 052483’’. days if needed. However, pond
■ 8. In § 522.2470, revise paragraphs (b), ■ 10. In § 524.1580a, in paragraph (d)(3), treatments for Ichthyophthirius spp.
(c)(1)(i) and (ii), and (c)(2) to read as in the second sentence, remove ‘‘in’’ should be made at 2-day intervals until
follows: and in its place add ‘‘on’’. control is achieved. Egg tanks may be
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![Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Rules and Regulations 58557
treated as often as necessary to prevent distribute, import, export, engage in produce physical dependence in mice.
growth of fungi. Do not use formalin research or conduct instructional This compound is a piperazine
which has been subjected to activities with, or possess), or propose derivative and is structurally unrelated
temperatures below 40 °F, or allowed to to handle, MT–45. to most other opioids. There are two
freeze. Treatments in tanks and DATES: Effective January 12, 2018. enantiomers of MT–45 (R and S). Both
raceways should never exceed 1 hour FOR FURTHER INFORMATION CONTACT: enantiomers bind to opioid receptors,
for fish or 4 hours for penaeid shrimp Michael J. Lewis, Diversion Control however (S)-(+)-MT–45 binds with a
(even if they show no sign of distress), Division, Drug Enforcement greater affinity than that of (R)-(¥)-MT–
nor should it exceed 15 minutes for fish Administration; Mailing Address: 8701 45. In functional studies, (S)-(+)-MT–45
eggs. Do not apply formalin to ponds Morrissette Drive, Springfield, Virginia has an analgesic effect similar to
with water warmer than 27 °C (80 °F), 22152; Telephone: (202) 598–6812. morphine. In comparison, the analgesic
when a heavy bloom of phytoplankton SUPPLEMENTARY INFORMATION: effect of (R)-(¥)-MT–45 is low.
is present, or when the concentration of Starting in 2013, MT–45 began
dissolved oxygen is less than 5 Legal Authority
appearing on the internet for sale as a
milligrams per liter. Section 201(d)(1) of the Controlled ‘legal’ opioid. Recent reports from Japan
Substances Act (CSA) (21 U.S.C. have indicated that MT–45 is present in
PART 558—NEW ANIMAL DRUGS FOR 811(d)(1)) states that, if control of a
USE IN ANIMAL FEEDS herbal and chemical mixtures
substance is required ‘‘by United States containing synthetic cannabinoids and/
■ 13. The authority citation for part 558 obligations under international treaties, or synthetic cathinones. Deaths
continues to read as follows: conventions, or protocols in effect on associated with MT–45 abuse have
October 27, 1970, the Attorney General occurred in the United States and in
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371. shall issue an order controlling such Europe. In addition, there have been at
drug under the schedule he deems most least 13 non-fatal overdoses associated
§ 558.58 [Amended] appropriate to carry out such with abuse of MT–45. There are no
■ 14. In § 558.58, remove paragraphs obligations, without regard to the published studies as to the safety of
(f)(4) and (5). findings required by subsection (a) of MT–45 for human use. The DEA is not
this section [811(a)] or section 812(b) aware of any claims or any medical or
§ 558.366 [Amended] . . . and without regard to the scientific literature suggesting that
■ 15. In § 558.366, remove paragraph procedures prescribed by subsections (a) MT–45 has a currently accepted medical
(e). and (b) of this section [21 U.S.C. 811(a) use in treatment in the United States.
Dated: December 5, 2017. and (b)] . . . .’’ If a substance is added Accordingly, the DEA has not requested
Leslie Kux,
to one of the schedules of the Single that the Department of Health and
Convention on Narcotic Drugs, 1961 Human Services (HHS) conduct a
Associate Commissioner for Policy.
(‘‘Single Convention’’), then, in scientific and medical evaluation of the
[FR Doc. 2017–26753 Filed 12–12–17; 8:45 am] accordance with article 3, paragraph 7 substance’s medical utility.
BILLING CODE 4164–01–P of the Convention, as a signatory Furthermore, the DEA is not required
Member State, the United States is under 21 U.S.C. 811(d)(1) to make any
obligated to control the substance under findings required by 21 U.S.C. 811(a) or
DEPARTMENT OF JUSTICE its national drug control legislation, the 812(b), and is not required to follow the
CSA. The Attorney General has procedures prescribed by 21 U.S.C.
Drug Enforcement Administration
delegated scheduling authority under 21 811(a) and (b). Therefore, consistent
U.S.C. 811 to the Administrator of the with the framework of 21 U.S.C. 811(d),
21 CFR Part 1308
DEA. 28 CFR 0.100. the DEA concludes that MT–45 has no
[Docket No. DEA–451] currently accepted medical use in
Background
Schedules of Controlled Substances: treatment in the United States and is
On May 17, 2016, the Secretary- most appropriately placed in schedule I
Placement of MT–45 Into Schedule I General of the United Nations advised of the CSA.
AGENCY: Drug Enforcement the Secretary of State of the United
Administration, Department of Justice. States, by letter, that during the 59th Conclusion
ACTION: Final order. session of the Commission on Narcotic
Drugs, MT–45 was added to schedule I In order to meet the obligations of the
SUMMARY: With the issuance of this final of the Single Convention. This letter United States under the Single
order, the Administrator of the Drug was prompted by a decision at the 59th Convention on Narcotic Drugs, 1961,
Enforcement Administration places the session of the Commission on Narcotic and because MT–45 has no currently
substance MT–45 (Systematic IUPAC Drugs in March 2016 to schedule accepted medical use in treatment in the
Name: 1-cyclohexyl-4-(1,2- MT–45 under schedule I of the Single United States, the Administrator of the
diphenylethyl)piperazine), including its Convention. As a signatory Member Drug Enforcement Administration has
salts, isomers, and salts of isomers into State to the Single Convention, the determined that this substance should
schedule I of the Controlled Substances United States is obligated to control be placed in schedule I of the Controlled
Act. This scheduling action is pursuant MT–45 under its national drug control Substances Act.
to the Controlled Substances Act and is legislation, the CSA, in the schedule Requirements for Handling
required in order for the United States deemed most appropriate to carry out its
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to discharge its obligations under the international obligations. 21 U.S.C. Upon the effective date of this final
Single Convention on Narcotic Drugs, 811(d)(1). order, MT–45 will become subject to the
1961. This action imposes the regulatory regulatory controls and administrative,
controls and administrative, civil, and MT–45 civil, and criminal sanctions applicable
criminal sanctions applicable to MT–45 is an opioid analgesic drug to the manufacture, distribution,
schedule I controlled substances on with pharmacological effects similar to importation, exportation, engagement in
persons who handle (manufacture, morphine. MT–45 was demonstrated to research, and conduct of instructional
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Document Created: 2017-12-13 01:23:38
Document Modified: 2017-12-13 01:23:38
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule; technical amendments. | |
| Dates | This rule is effective December 13, 2017. | |
| 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] | |
| FR Citation | 82 FR 58554 | |
| CFR Citation | 21
CFR
510 21 CFR 520 21 CFR 522 21 CFR 524 21 CFR 529 21 CFR 558 | |
| CFR Associated | Administrative Practice and Procedure; Animal Drugs; Labeling; Reporting and Recordkeeping Requirements and Animal Feeds |
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