Federal Register - November 8, 2021
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Source: Federal Register
Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations
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TABLE 1ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING APRIL, MAY, AND JUNE 2021
Continued Species
Effect of the action
Public documents
CREDELIO CAT
lotilaner Chewable Tablets.
Cats
FOI Summary.
Cronus Pharma Specialties India Private Ltd., Sy No-99/1, M/s GMR
Hyderabad Aviation SEZ Ltd., Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, India.
Intervet, Inc., 2 Giralda Farms, Madison, NJ
07940.
Amoxicillin and Clavulanate Potassium Tablets.
Dogs and cats
Supplemental approval for treatment and control of black-legged tick infestations for one month in cats and kittens.
Original approval as a generic copy of NADA 055099.
SAFEGUARD
fenbendazole Type C
free-choice medicated feed blocks.
Cattle
FOI Summary.
141452
Zoetis Inc., 333 Portage St., Kalamazoo, MI
49007.
SIMPARICA sarolaner Chewables.
Dogs
May 26, 2021
140269
Do
KETOFEN ketoprofen Injectable Solution.
Cattle
June 1, 2021
141543
Do
Cattle
June 10, 2021
200700
June 10, 2021
200701
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland.
Do
Cats
Original approval as a generic copy of NADA 141254.
FOI Summary.
June 14, 2021
128620
Intervet, Inc., 2 Giralda Farms, Madison, NJ
07940.
DRAXXIN KP
tulathromycin and ketoprofen Injectable Solution.
PARASEDGE Multi for Dogs imidacloprid and moxidectin Topical Solution.
PARASEDGE Multi for Cats imidacloprid and moxidectin Topical Solution.
SAFEGUARD
fenbendazole Suspension.
Supplemental approval providing for a tolerance and tissue withdrawal periods in accordance with a repartitioning of the acceptable daily intake ADI; and the addition of indications for 4th-stage larval forms of certain endoparasites.
Supplemental approval for the prevention of Borrelia burgdorferi infection as a direct result of killing Ixodes scapularis vector ticks.
Supplemental approval for control of pyrexia associated with bovine respiratory disease BRD and establishing a tolerance for residues of ketoprofen in edible tissues of cattle.
Original approval for the treatment of bovine respiratory disease BRD
and control of pyrexia associated with BRD in certain classes of cattle.
Original approval as a generic copy of NADA 141234.
FOI Summary.
June 14, 2021
200704
June 28, 2021
200706
Felix Pharmaceuticals PVT Ltd., 2528 North Wall Quay, Dublin, 1, Ireland.
Do
Supplemental approval to establish a milk discard time in cattle and a goat tissue tolerance in accordance with repartitioning of the ADI.
Original approval as a generic copy of NADA 141203.
Approval date
File No.
Sponsor
Product name
April 12, 2021
141528
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.
April 23, 2021
200702
April 26, 2021
139189
May 18, 2021
Dogs
Deracoxib Chewable Tablets.
Dogs
Carprofen Chewable Tablets.
Dogs
II. Change of Sponsors Address Alexion Pharmaceuticals, Inc., 100
College St., New Haven, CT 06510 has informed FDA that it has changed its address to 121 Seaport Blvd., Boston, MA 02210.
Purina Animal Nutrition LLC, 1080
County Road F West, Shoreview, MN
551262910 has informed FDA that it has changed its address to 4001
Lexington Ave., North Arden Hills, MN
551262910.
21 CFR part 522 is amended to organize sections for injectable pentobarbital drugs by their titles in alphabetic sequence.
21 CFR 558.128 is amended to add introductory text identifying the paragraph for medicated cattle feeds containing chlortetracycline.
21 CFR 558.355 is amended to add introductory text identifying the paragraph for medicated cattle feeds containing monensin.
III. Technical Amendments FDA is making the following amendment to improve the accuracy of the animal drug regulations:
21 CFR 520.304 is amended to reflect the currently approved strengths of carprofen chewable tablets.
IV. Legal Authority
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Original approval as a generic copy of NADA 141111.
This final rule is issued under section 512i of the Federal Food, Drug, and Cosmetic Act FD&C Act 21 U.S.C.
360bi, which requires Federal Register publication of notices . . .
effective as a regulation, of the
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FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
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. 8043A because it is a rule of particular applicability.
Therefore, it is not subject to the congressional review requirements in 5
U.S.C. 801808. Likewise, this is not a rule subject to Executive Order 12866, which defines a rule as an agency statement of general applicability and
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