83 FR 14584 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 66 (April 5, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 66 (April 5, 2018)
| Page Range | 14584-14588 | |
| FR Document | 2018-06961 |
[Federal Register Volume 83, Number 66 (Thursday, April 5, 2018)] [Rules and Regulations] [Pages 14584-14588] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06961] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 526, and 558 [Docket No. FDA-2017-N-0002] New Animal Drugs; 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. ----------------------------------------------------------------------- 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 October, November, and December 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 changes of sponsorship of applications and a change of a sponsor's name and address. DATES: This rule is effective April 5, 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: [[Page 14585]] I. Approval Actions FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during October, November, and December 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 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 October, November, and December 2017 ---------------------------------------------------------------------------------------------------------------- Effect of the Approval date File No. Sponsor Product name Species action Public documents ---------------------------------------------------------------------------------------------------------------- October 27, 141-467 Elanco US Inc., Avilamycin and Chickens...... Original FOI Summary; EA/ 2017. 2500 Innovation narasin Type C approval for FONSI. \1\ Way, medicated feeds. use of Greenfield, IN INTREPITY 46140. (avilamycin) and MONTEBAN (narasin) Type A medicated articles to manufacture Type C medicated broiler chicken feeds for the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens, and the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima. October 27, 141-466 Elanco US Inc., Avilamycin, Chickens...... Original FOI Summary; EA/ 2017. 2500 Innovation narasin, and approval for FONSI. \1\ Way, nicarbazin Type use of Greenfield, IN C medicated INTREPITY 46140. feeds. (avilamycin) and MAXIBAN (narasin and nicarbazin) Type A medicated articles to manufacture Type C medicated broiler chicken feeds for the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens, and the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima. November 9, 106-111 Zoetis Inc., 333 TELAZOL Dogs.......... Supplemental FOI Summary. 2017. Portage St., (tiletamine and approval for Kalamazoo, MI zolazepam for intravenous 49007. injection). administration in dogs for induction of anesthesia followed by maintenance with an inhalant anesthetic. November 21, 200-473 Huvepharma EOOD, TYLOVET (tylosin Chickens...... Supplemental FOI Summary. 2017. 5th Floor, 3A tartrate) approval for Nikolay Haytov Soluble Powder. the control of Str., 1113 mortality Sofia, Bulgaria. caused by necrotic enteritis associated with Clostridium perfringens in broiler chickens. November 30, 097-505 Zoetis Inc., 333 Lincomycin Type Swine......... Supplemental ................ 2017. Portage St., B and Type C approval for Kalamazoo, MI medicated feeds. use of 49007. LINCOMIX (lincomycin) Type A medicated articles to manufacture Type B and Type C medicated swine feeds for reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae. December 11, 141-441 Virbac AH, Inc., IVERHART MAX Dogs.......... Original FOI Summary. 2017. 3200 Meacham (ivermectin, approval of a Blvd., Ft. pyrantel soft chewable Worth, TX 76137. pamoate, tablet to praziquantel) prevent canine Soft Chew. heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection and for the treatment and control of roundworm (Toxocara canis, Toxascaris leonina), hookworm (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense), and tapeworm (Dipylidium caninum, Taenia pisiformis) infections. December 12, 200-617 Pharmgate LLC, Chlortetracyclin Cattle........ Original ................ 2017. 1800 Sir Tyler e and lasalocid approval for Dr., Type B and Type use of DERACIN Wilmington, NC C medicated (chlortetracyc 28405. feeds. line) and BOVATEC (lasalocid) Type A medicated articles to manufacture Type B and Type C medicated cattle feeds as a generic copy of NADA 141-250. ---------------------------------------------------------------------------------------------------------------- \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). II. Changes of Sponsorship Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS 66211 has informed FDA that it has transferred ownership of, and all rights and interest in, the following application to Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140: [[Page 14586]] ------------------------------------------------------------------------ File No. Product name 21 CFR section ------------------------------------------------------------------------ 141-455........................ GALLIPRANT (grapiprant) 520.1084 Tablets. ------------------------------------------------------------------------ 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 applications to HQ Specialty Pharma Corp., 120 Rte. 17 North, suite 130, Paramus, NJ 07652: ------------------------------------------------------------------------ File No. Product name 21 CFR section ------------------------------------------------------------------------ 055-097........................ DRY-MAST (pen G 526.1696b procaine/ dihydrostreptomycin sulfate) Infusion. ------------------------------------------------------------------------ Ridley Block Operations Inc., 424 North Riverfront Dr., P.O. Box 8500, Mankato, MN 56002-8500 has informed FDA that it has transferred ownership of, and all rights and interest in, the following applications to Ridley USA, Inc., 111 W Cherry St., suite 500, Mankato, MN 56001: ------------------------------------------------------------------------ File No. Product name 21 CFR section ------------------------------------------------------------------------ 141-187........................ CRYSTALYX IONO-LYX 558.311 (lasalocid) Type C Medicated Protein Block. ------------------------------------------------------------------------ Ridley U.S. Holdings, Inc., 424 North Riverfront Dr., P.O. Box 8500, Mankato, MN 56002-8500 has informed FDA that it has transferred ownership of, and all rights and interest in, the following application to Ridley USA, Inc., 111 W Cherry St., suite 500, Mankato, MN 56001: ------------------------------------------------------------------------ File No. Product name 21 CFR section ------------------------------------------------------------------------ 033-733........................ SWEETLIX BLOAT-GUARD 520.1840 (poloxalene) Pressed Block. ------------------------------------------------------------------------ Accordingly, the animal drug regulations are being amended to reflect these changes of sponsorship. Following these withdrawals of approval, neither Ridley Block Operations, Inc. nor Ridley U.S. Holdings, Inc. is the sponsor of an approved application. Accordingly, these firms will be removed from the list of sponsors of approved applications in Sec. 510.600(c) (21 CFR 510.600(c)). III. 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 ``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, and 526 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, 526, 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 entry for ``Ridley Block Operations, Inc.'' and revise the entry for ``Ridley U.S. Holdings, Inc.''; and in the table in paragraph (c)(2), remove the entry for ``068287'' and revise the entry for ``067949''. The revisions read as follows: Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * * * (c) * * * (1) * * * [[Page 14587]] ------------------------------------------------------------------------ Firm name and address Drug labeler code ------------------------------------------------------------------------ * * * * * * * Ridley USA, Inc., 111 W Cherry St., Suite 500, 067949 Mankato, MN 56001............................ * * * * * * * ------------------------------------------------------------------------ (2) * * * ------------------------------------------------------------------------ Drug labeler code Firm name and address ------------------------------------------------------------------------ * * * * * * * 067949........................................ Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001. * * * * * * * ------------------------------------------------------------------------ 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. Sec. 520.1084 [Amended] 0 4. In Sec. 520.1084, in paragraph (b), remove ``086026'' and in its place add ``058198''. Sec. 520.1199 [Amended] 0 5. In Sec. 520.1199, in paragraph (a) introductory text, remove ``chewable tablet'' and in its place add ``chewable tablet or soft chewable tablet''; and in paragraph (c)(2), remove ``Prevents'' and in its place add ``To prevent''. 0 6. In Sec. 520.2640, revise paragraphs (b)(1) and (2) to read as follows: Sec. 520.2640 Tylosin. * * * * * (b) * * * (1) Nos. 016592 and 058198 for use as in paragraph (e) of this section. (2) No. 061623 for use as in paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2), (e)(3), and (e)(4) of this section. * * * * * PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 7. The authority citation for part 522 continues to read as follows: Authority: 21 U.S.C. 360b. 0 8. In Sec. 522.2470, revise paragraphs (b) and (c) to read as follows: Sec. 522.2470 Tiletamine and zolazepam for injection. * * * * * (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter: (1) No. 054771 for use as in paragraph (c) of this section. (2) Nos. 026637 and 051311 for use as in paragraphs (c)(1)(i)(A), (c)(1)(ii)(A), (c)(1)(iii) and (c)(2) of this section. (c) Conditions of use--(1) Dogs--(i) Amount. Expressed as milligrams of the drug combination: (A) 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. (B) Administer intravenously at 1 to 2 mg/lb (2.2 to 4.4 mg/kg) body weight to effect for induction of anesthesia followed by maintenance with an inhalant anesthetic. (ii) Indications for use. (A) Intramuscular administration in dogs for restraint and minor procedures of short duration (30 minutes average) requiring mild to moderate analgesia. (B) Intravenous administration in dogs for induction of anesthesia followed by maintenance with an inhalant anesthetic. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats--(i) Amount. 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. (ii) Indications for use. For restraint or for anesthesia combined with muscle relaxation. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS 0 9. The authority citation for part 526 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 526.1696b [Amended] 0 10. In Sec. 526.1696b, in paragraph (b), remove ``054628'' and in its place add ``042791''. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 11. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 0 12. In Sec. 558.68, add paragraphs (e)(1)(iii) and (iv) to read as follows: Sec. 558.68 Avilamycin. * * * * * (e) * * * (1) * * * [[Page 14588]] ---------------------------------------------------------------------------------------------------------------- Combination in Avilamycin in grams/ton grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (iii) 13.6 to 40.9.............. Narasin,........... Broiler chickens: Feed as the sole ration 058198 54 to 90........... For the prevention for 21 consecutive of mortality days to chickens that caused by necrotic are at risk of enteritis developing, but not associated with yet showing clinical Clostridium signs of, necrotic perfringens; and enteritis associated for the prevention with Clostridium of coccidiosis perfringens. To assure caused by Eimeria responsible necatrix, E. antimicrobial drug use tenella, E. in broiler chickens, acervulina, E. treatment brunetti, E. administration must mivati, and E. begin on or before 10 maxima. days of age. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Narasin as provided by No. 058198 in Sec. 510.600(c) of this chapter. (iv) 13.6 to 40.9............... Narasin............ Broiler chickens: Feed as the sole ration 058198 27 to 45;.......... For the prevention for 21 consecutive nicarbazin......... of mortality days to chickens that 27 to 45........... caused by necrotic are at risk of enteritis developing, but not associated with yet showing clinical Clostridium signs of, necrotic perfringens; and enteritis associated for the prevention with Clostridium of coccidiosis perfringens. To assure caused by Eimeria responsible necatrix, E. antimicrobial drug use tenella, E. in broiler chickens, acervulina, E. treatment brunetti, E. administration must mivati, and E. begin on or before 10 maxima. days of age. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Do not feed to laying hens. Withdraw 5 days before slaughter. Narasin and nicarbazin as provided by No. 058198 in Sec. 510.600(c) of this chapter. ---------------------------------------------------------------------------------------------------------------- * * * * * Sec. 558.128 [Amended] 0 13. In Sec. 558.128, in paragraph (e)(4), in the ``Sponsor'' column, numerically add ``069254'' to paragraphs (e)(4)(ii), (vii), (viii), (ix), and (xviii) through (xxvi). Sec. 558.311 [Amended] 0 14. In Sec. 558.311, in paragraph (b)(9) and in paragraph (e)(1)(xix), in the ``Sponsor'' column, remove ``068287'' and in its place add ``067949''. 0 15. In Sec. 558.325 revise paragraph (e)(2)(xiv) to read as follows: Sec. 558.325 Lincomycin. * * * * * (e) * * * (2) * * * ---------------------------------------------------------------------------------------------------------------- Combination in Lincomycin grams/ton grams/ton Indications for use Limitations Sponsors ---------------------------------------------------------------------------------------------------------------- * * * * * * * (xiv) 100 to 200............... .................. For reduction in the Feed as sole 054771 severity of the ration for 21 effects of respiratory days. disease associated with Mycoplasma hyopneumoniae. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * Dated: March 29, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-06961 Filed 4-4-18; 8:45 am] BILLING CODE 4164-01-P
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expressed as ‘‘Estimated Energy Cost’’ in statement: ‘‘Contains Mercury For more included in both languages. Numeric
dollars and based on usage of 3 hours on clean up and safe disposal, visit characters that are identical in both
per day and 11 cents ($0.11) per kWh. epa.gov/cfl.’’ The manufacturer may languages need not be repeated.
(2) Principal display panel format. also print an ‘‘Hg[Encircled]’’ symbol on (7) Product labeling. Any general
The light output (brightness) and energy the label after the term ‘‘Contains service lamp shall be labeled legibly on
cost shall appear in that order and with Mercury’’; and the product with the following
equal clarity and conspicuousness on (ix) No marks or information other information:
the principal display panel of the than that specified in this part shall (i) The lamp’s average initial lumens,
product package. The format, terms, appear on the Lighting Facts label. expressed as a number rounded to the
specifications, and minimum sizes shall (4) Standard Lighting Facts label nearest five, adjacent to the word
follow the specifications and minimum format. Except as provided in paragraph ‘‘lumens,’’ both provided in minimum 8
sizes displayed in Prototype Label 5 in (b)(5) of this section, information point font; and
appendix L of this part. specified in paragraph (b)(3) of this (ii) For general service lamps
(3) Lighting Facts label content. The section shall be presented on covered containing mercury, the following
side or rear display panel of the product lamp packages in the format, terms, statement: ‘‘Mercury disposal: epa.gov/
package shall be labeled clearly and explanatory text, specifications, and cfl’’ in minimum 8 point font.
conspicuously with a Lighting Facts minimum sizes as shown in Prototype * * * * *
label that contains the following Labels 6 in appendix L of this part and
information in the following order: By direction of the Commission.
consistent in format and orientation
(i) The light output of each lamp with Sample Labels 10, 11, or 12 in Donald S. Clark,
included in the package, expressed as appendix L. The text and lines shall be Secretary.
‘‘Brightness’’ in average initial lumens all black or one color type, printed on [FR Doc. 2018–06694 Filed 4–4–18; 8:45 am]
rounded to the nearest five; a white or other neutral contrasting BILLING CODE 6750–01–P
(ii) The estimated annual energy cost background whenever practical.
of each lamp included in the package (i) The Lighting Facts information
based on the average initial wattage, a shall be set off in a box by use of DEPARTMENT OF HEALTH AND
usage rate of 3 hours per day and 11 hairlines and shall be all black or one HUMAN SERVICES
cents ($0.11) per kWh and explanatory color type, printed on a white or other
text as illustrated in Prototype Label 6 neutral contrasting background Food and Drug Administration
in appendix L of this part; whenever practical.
(iii) The life, as defined in § 305.2(w), (ii) All information within the 21 CFR Parts 510, 520, 522, 526, and
of each lamp included in the package, Lighting Facts label shall utilize: 558
expressed in years rounded to the (A) Arial or an equivalent type style;
(B) Upper and lower case letters; [Docket No. FDA–2017–N–0002]
nearest tenth (based on 3 hours
operation per day); (C) Leading as indicated in Prototype
New Animal Drugs; Approval of New
(iv) The correlated color temperature Label 6 in appendix L of this part;
Animal Drug Applications; Changes of
of each lamp included in the package, (D) Letters that never touch;
(E) The box and hairlines separating Sponsorship; Change of a Sponsor’s
as measured in degrees Kelvin and
information as illustrated in Prototype Name and Address
expressed as ‘‘Light Appearance’’ and
by a number and a marker in the form Labels 6 in appendix L of this part; and AGENCY: Food and Drug Administration,
of a scale as illustrated in Prototype (F) The minimum font sizes and line HHS.
Label 6 to appendix L of this part placed thicknesses as illustrated in Prototype ACTION: Final rule.
proportionately on the scale where the Label 6 in appendix L of this part.
left end equals 2,600 K and the right end (5) Lighting Facts format for small SUMMARY: The Food and Drug
equals 6,600 K; packages. If the total surface area of the Administration (FDA or we) is
(v) The wattage, as defined in product package available for labeling is amending the animal drug regulations to
§ 305.2(hh), for each lamp included in less than 24 square inches and the reflect application-related actions for
the package, expressed as energy used package shape or size cannot new animal drug applications (NADAs)
in average initial wattage; accommodate the standard label and abbreviated new animal drug
(vi) The ENERGY STAR logo as required by paragraph (b)(4) of this applications (ANADAs) during October,
illustrated in Prototype Label 6 to section, manufacturers may provide the November, and December 2017. FDA is
appendix L of this part for certified information specified in paragraph informing the public of the availability
products, if desired by the manufacturer (b)(3) of this section using a smaller, of summaries of the basis of approval
or private labeler. Only manufacturers linear label following the format, terms, and of environmental review
or private labelers that have signed a explanatory text, specifications, and documents, where applicable. The
Memorandum of Understanding with minimum sizes illustrated in Prototype animal drug regulations are also being
the Department of Energy or the Label 7 in appendix L of this part. amended to reflect changes of
Environmental Protection Agency may (6) Bilingual labels. The information sponsorship of applications and a
add the ENERGY STAR logo to labels on required by paragraphs (b)(1) through change of a sponsor’s name and address.
certified covered products; such (5) of this section may be presented in DATES: This rule is effective April 5,
manufacturers or private labelers may a second language either by using 2018.
add the ENERGY STAR logo to labels separate labels for each language or in
only on those products that are covered a bilingual label with the English text in FOR FURTHER INFORMATION CONTACT:
amozie on DSK30RV082PROD with RULES
by the Memorandum of Understanding; the format required by this section George K. Haibel, Center for Veterinary
(vii) The design voltage of each lamp immediately followed by the text in the Medicine (HFV–6), Food and Drug
included in the package, if other than second language. Sample Label 13 in Administration, 7500 Standish Pl.,
120 volts; appendix L of this part provides an Rockville, MD 20855, 240–402–5689,
(viii) For any general service lamp example of a bilingual Lighting Facts george.haibel@fda.hhs.gov.
containing mercury, the following label. All required information must be SUPPLEMENTARY INFORMATION:
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21 CFR
File No. Product name section
141–455 .................................................... GALLIPRANT (grapiprant) Tablets .............................................................................. 520.1084
Strategic Veterinary Pharmaceuticals, transferred ownership of, and all rights Corp., 120 Rte. 17 North, suite 130,
Inc., 100 NW Airport Rd., St. Joseph, and interest in, the following Paramus, NJ 07652:
MO 64503 has informed FDA that it has applications to HQ Specialty Pharma
21 CFR
File No. Product name section
055–097 .................................................... DRY–MAST (pen G procaine/dihydrostreptomycin sulfate) Infusion .......................... 526.1696b
Ridley Block Operations Inc., 424 FDA that it has transferred ownership Inc., 111 W Cherry St., suite 500,
North Riverfront Dr., P.O. Box 8500, of, and all rights and interest in, the Mankato, MN 56001:
Mankato, MN 56002–8500 has informed following applications to Ridley USA,
21 CFR
File No. Product name section
141–187 .................................................... CRYSTALYX IONO–LYX (lasalocid) Type C Medicated Protein Block ...................... 558.311
Ridley U.S. Holdings, Inc., 424 North it has transferred ownership of, and all Cherry St., suite 500, Mankato, MN
Riverfront Dr., P.O. Box 8500, Mankato, rights and interest in, the following 56001:
MN 56002–8500 has informed FDA that application to Ridley USA, Inc., 111 W
21 CFR
File No. Product name section
033–733 .................................................... SWEETLIX BLOAT–GUARD (poloxalene) Pressed Block .......................................... 520.1840
Accordingly, the animal drug document does not meet the definition Therefore, under the Federal Food,
regulations are being amended to reflect of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because Drug, and Cosmetic Act and under
these changes of sponsorship. Following it is a ‘‘rule of particular applicability.’’ authority delegated to the Commissioner
these withdrawals of approval, neither Therefore, it is not subject to the of Food and Drugs, 21 CFR parts 510,
Ridley Block Operations, Inc. nor Ridley congressional review requirements in 5 520, 522, 526, and 558 are amended as
U.S. Holdings, Inc. is the sponsor of an U.S.C. 801–808. Likewise, this is not a follows:
approved application. Accordingly, rule subject to Executive Order 12866,
these firms will be removed from the list which defines a rule as ‘‘an agency PART 510—NEW ANIMAL DRUGS
of sponsors of approved applications in statement of general applicability and
§ 510.600(c) (21 CFR 510.600(c)). future effect, which the agency intends ■ 1. The authority citation for part 510
to have the force and effect of law, that continues to read as follows:
III. Legal Authority
is designed to implement, interpret, or Authority: 21 U.S.C. 321, 331, 351, 352,
This final rule is issued under section prescribe law or policy or to describe 353, 360b, 371, 379e.
512(i) of the Federal Food, Drug, and the procedure or practice requirements ■ 2. In § 510.600, in the table in
Cosmetic Act (FD&C Act) (21 of an agency.’’ paragraph (c)(1), remove the entry for
U.S.C.360b(i)), which requires Federal ‘‘Ridley Block Operations, Inc.’’ and
List of Subjects
Register publication of ‘‘notice[s] . . . revise the entry for ‘‘Ridley U.S.
effective as a regulation,’’ of the 21 CFR Part 510 Holdings, Inc.’’; and in the table in
conditions of use of approved new paragraph (c)(2), remove the entry for
animal drugs. This rule sets forth Administrative practice and
‘‘068287’’ and revise the entry for
technical amendments to the regulations procedure, Animal drugs, Labeling,
‘‘067949’’.
to codify recent actions on approved Reporting and recordkeeping
requirements. The revisions read as follows:
new animal drug applications and
corrections to improve the accuracy of 21 CFR Parts 520, 522, and 526 § 510.600 Names, addresses, and drug
the regulations, and as such does not labeler codes of sponsors of approved
impose any burden on regulated Animal drugs. applications.
amozie on DSK30RV082PROD with RULES
entities. * * * * *
21 CFR Part 558
Although denominated a rule (c) * * *
pursuant to the FD&C Act, this Animal drugs, Animal feeds. (1) * * *
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![Federal Register / Vol. 83, No. 66 / Thursday, April 5, 2018 / Rules and Regulations 14587
Firm name and address Drug labeler code
* * * * * * *
Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001 ................................................................................ 067949
* * * * * * *
(2) * * *
Drug labeler code Firm name and address
* * * * * * *
067949 ................................................................................................................................................................................. Ridley USA, Inc., 111 W
Cherry St., Suite 500,
Mankato, MN 56001.
* * * * * * *
PART 520—ORAL DOSAGE FORM (1) No. 054771 for use as in paragraph and other procedures of short duration.
NEW ANIMAL DRUGS (c) of this section. Initial dosages of 6.5 to 7.2 mg/lb of
(2) Nos. 026637 and 051311 for use as body weight are recommended for
■ 3. The authority citation for part 520 in paragraphs (c)(1)(i)(A), (c)(1)(ii)(A), ovariohysterectomy and onychectomy.
continues to read as follows: (c)(1)(iii) and (c)(2) of this section. When supplemental doses are required,
Authority: 21 U.S.C. 360b. (c) Conditions of use—(1) Dogs—(i) such individual supplemental doses
Amount. Expressed as milligrams of the should be given in increments that are
§ 520.1084 [Amended] drug combination: less than the initial dose and the total
(A) An initial intramuscular dosage of dose given (initial dose plus
■ 4. In § 520.1084, in paragraph (b),
3 to 4.5 milligrams per pound (mg/lb) of supplemental doses) should not exceed
remove ‘‘086026’’ and in its place add
body weight for diagnostic purposes; 4.5 the maximum allowable safe dose of
‘‘058198’’.
to 6 mg/lb of body weight for minor 32.7 mg/lb of body weight.
§ 520.1199 [Amended] procedures of short duration such as
repair of lacerations and wounds, (ii) Indications for use. For restraint or
■ 5. In § 520.1199, in paragraph (a) for anesthesia combined with muscle
castrations, and other procedures
introductory text, remove ‘‘chewable relaxation.
requiring mild to moderate analgesia.
tablet’’ and in its place add ‘‘chewable
Supplemental doses when required (iii) Limitations. Federal law restricts
tablet or soft chewable tablet’’; and in
should be less than the initial dose and this drug to use by or on the order of
paragraph (c)(2), remove ‘‘Prevents’’ and
the total dose given should not exceed a licensed veterinarian.
in its place add ‘‘To prevent’’.
12 mg/lb of body weight. The maximum
■ 6. In § 520.2640, revise paragraphs total safe dose is 13.6 mg/lb of body PART 526—INTRAMAMMARY DOSAGE
(b)(1) and (2) to read as follows: weight. FORM NEW ANIMAL DRUGS
§ 520.2640 Tylosin.
(B) Administer intravenously at 1 to 2
mg/lb (2.2 to 4.4 mg/kg) body weight to ■ 9. The authority citation for part 526
* * * * * effect for induction of anesthesia continues to read as follows:
(b) * * * followed by maintenance with an
(1) Nos. 016592 and 058198 for use as Authority: 21 U.S.C. 360b.
inhalant anesthetic.
in paragraph (e) of this section. (ii) Indications for use. (A) § 526.1696b [Amended]
(2) No. 061623 for use as in Intramuscular administration in dogs for
paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2), restraint and minor procedures of short ■ 10. In § 526.1696b, in paragraph (b),
(e)(3), and (e)(4) of this section. duration (30 minutes average) requiring remove ‘‘054628’’ and in its place add
* * * * * mild to moderate analgesia. ‘‘042791’’.
(B) Intravenous administration in
PART 522—IMPLANTATION OR dogs for induction of anesthesia PART 558—NEW ANIMAL DRUGS FOR
INJECTABLE DOSAGE FORM NEW followed by maintenance with an USE IN ANIMAL FEEDS
ANIMAL DRUGS inhalant anesthetic.
(iii) Limitations. Federal law restricts ■ 11. The authority citation for part 558
■ 7. The authority citation for part 522 this drug to use by or on the order of continues to read as follows:
continues to read as follows: a licensed veterinarian. Authority: 21 U.S.C. 354, 360b, 360ccc,
Authority: 21 U.S.C. 360b. (2) Cats—(i) Amount. An initial 360ccc–1, 371.
■ 8. In § 522.2470, revise paragraphs (b) intramuscular dosage of 4.4 to 5.4 mg/
lb of body weight is recommended for ■ 12. In § 558.68, add paragraphs
and (c) to read as follows:
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such procedures as dentistry, treatment (e)(1)(iii) and (iv) to read as follows:
§ 522.2470 Tiletamine and zolazepam for of abscesses, foreign body removal, and § 558.68 Avilamycin.
injection. related types of surgery; 4.8 to 5.7 mg/ * * * * *
* * * * * lb of body weight for minor procedures
(b) Sponsors. See sponsors in requiring mild to moderate analgesia, (e) * * *
§ 510.600(c) of this chapter: such as repair of lacerations, castrations, (1) * * *
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![14588 Federal Register / Vol. 83, No. 66 / Thursday, April 5, 2018 / Rules and Regulations
Avilamycin in grams/ Combination in Indications for use Limitations Sponsor
ton grams/ton
* * * * * * *
(iii) 13.6 to 40.9 .......... Narasin, ..................... Broiler chickens: For the preven- Feed as the sole ration for 21 consecutive 058198
54 to 90 ..................... tion of mortality caused by ne- days to chickens that are at risk of devel-
crotic enteritis associated with oping, but not yet showing clinical signs
Clostridium perfringens; and of, necrotic enteritis associated with Clos-
for the prevention of coccidi- tridium perfringens. To assure responsible
osis caused by Eimeria antimicrobial drug use in broiler chickens,
necatrix, E. tenella, E. treatment administration must begin on or
acervulina, E. brunetti, E. before 10 days of age. Do not allow adult
mivati, and E. maxima. turkeys, horses, or other equines access
to narasin formulations. Ingestion of
narasin by these species has been fatal.
Narasin as provided by No. 058198 in
§ 510.600(c) of this chapter.
(iv) 13.6 to 40.9 .......... Narasin ...................... Broiler chickens: For the preven- Feed as the sole ration for 21 consecutive 058198
27 to 45; .................... tion of mortality caused by ne- days to chickens that are at risk of devel-
nicarbazin .................. crotic enteritis associated with oping, but not yet showing clinical signs
27 to 45 ..................... Clostridium perfringens; and of, necrotic enteritis associated with Clos-
for the prevention of coccidi- tridium perfringens. To assure responsible
osis caused by Eimeria antimicrobial drug use in broiler chickens,
necatrix, E. tenella, E. treatment administration must begin on or
acervulina, E. brunetti, E. before 10 days of age. Do not allow adult
mivati, and E. maxima. turkeys, horses, or other equines access
to narasin formulations. Ingestion of
narasin by these species has been fatal.
Do not feed to laying hens. Withdraw 5
days before slaughter. Narasin and
nicarbazin as provided by No. 058198 in
§ 510.600(c) of this chapter.
* * * * * § 558.311 [Amended] § 558.325 Lincomycin.
§ 558.128 [Amended] ■ 14. In § 558.311, in paragraph (b)(9) * * * * *
■ 13. In § 558.128, in paragraph (e)(4), and in paragraph (e)(1)(xix), in the (e) * * *
in the ‘‘Sponsor’’ column, numerically ‘‘Sponsor’’ column, remove ‘‘068287’’ (2) * * *
add ‘‘069254’’ to paragraphs (e)(4)(ii), and in its place add ‘‘067949’’.
(vii), (viii), (ix), and (xviii) through ■ 15. In § 558.325 revise paragraph
(xxvi). (e)(2)(xiv) to read as follows:
Combination in
Lincomycin grams/ton Indications for use Limitations Sponsors
grams/ton
* * * * * * *
(xiv) 100 to 200 .......... ................................... For reduction in the severity of the effects Feed as sole ration for 21 days 054771
of respiratory disease associated with
Mycoplasma hyopneumoniae.
* * * * * * *
* * * * * DEPARTMENT OF DEFENSE SUMMARY: This final rule removes the
Dated: March 29, 2018. Department of Defense (DoD) regulation
Office of the Secretary concerning defense support of civilian
Leslie Kux,
law enforcement agencies. This part
Associate Commissioner for Policy. 32 CFR Part 182 establishes DoD policy, assigns
[FR Doc. 2018–06961 Filed 4–4–18; 8:45 am] responsibilities, and provides
BILLING CODE 4164–01–P [Docket ID: DOD–2017–OS–0052] procedures to key DoD individuals who
provide support to Federal, State,
RIN 0790–AK04 Tribal, and local civilian law
enforcement agencies within the United
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Defense Support of Civilian Law States, including the District of
Enforcement Agencies Columbia, the Commonwealth of Puerto
AGENCY: Under Secretary of Defense for Rico, the U.S. Virgin Islands, Guam,
Policy, DoD. American Samoa, the Commonwealth of
the Northern Mariana Islands, and any
ACTION: Final rule.
territory or possession of the United
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Document Created: 2018-11-01 09:14:03
Document Modified: 2018-11-01 09:14:03
| 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. | |
| Dates | This rule is effective April 5, 2018. | |
| 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 | 83 FR 14584 | |
| CFR Citation | 21
CFR
510 21 CFR 520 21 CFR 522 21 CFR 526 21 CFR 558 | |
| CFR Associated | Administrative Practice and Procedure; Animal Drugs; Labeling; Reporting and Recordkeeping Requirements and Animal Feeds |
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