Federal Register - March 19, 2021
Versione di testo Cosa è?Dateas è un sito indipendente non affiliato a entità governative. La fonte dei documenti PDF che pubblichiamo qui è l'entità governativa indicata in ciascuno di essi. Le versioni in testo sono trascrizioni che realizziamo per facilitare l'accesso e la ricerca di informazioni, ma possono contenere errori o non essere complete.
Source: Federal Register
14815
Federal Register / Vol. 86, No. 52 / Friday, March 19, 2021 / Rules and Regulations humanitarian reasons or for other purposes in the national interest, permit the processing of travelers to the United States not engaged in essential travel.
Final rule; technical amendments.
ACTION:
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsors Name and Address
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 2020. 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 improve the accuracy and readability of the regulations.
DATES: This rule is effective March 19, 2021.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary Medicine HFV6, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 2404025689, george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration, Department of Health and Human Services HHS.
I. Approvals FDA is amending the animal drug regulations to reflect approval actions
Alejandro N. Mayorkas, Secretary, U.S. Department of Homeland Security.
FR Doc. 202105877 Filed 31821; 8:45 am BILLING CODE 9112FPP
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 529, 556, and 558
Docket No. FDA2020N0002
AGENCY:
SUMMARY:
for NADAs and ANADAs during July, August, and September 2020, 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 office of 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, 2404027500.
Persons with access to the internet may obtain these documents at the CVM
FOIA Electronic Reading Room: https
www.fda.gov/about-fda/centerveterinary-medicine/cvm-foiaelectronic-reading-room. Marketing exclusivity and patent information may be accessed in FDAs publication, Approved Animal Drug Products Online Green Book at: https www.fda.gov/
animal-veterinary/products/approvedanimal-drug-products-green-book.
jbell on DSKJLSW7X2PROD with RULES
TABLE 1ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY, AUGUST, AND
SEPTEMBER 2020
Species
Effect of the action
Public documents
BRAVECTO 1-MONTH
furalaner Chews for Dogs.
Dogs
FOI Summary.
Ceva Sante Animale, 10
Avenue de la Ballastiere, 33500
Libourne, France.
CARDALIS
spironolactone and benazepril hydrochloride chewable tablets.
Dogs
Cronus Pharma Specialities India Private Ltd., Sy No-99/1, GMR
Hyderabad Aviation SEZ Ltd., Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, India.
Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211.
Pharmgate LLC, 1800 Sir Tyler Dr., Wilmington, NC 28405.
Carprofen Chewable Tablets.
Dogs
Original approval for the treatment and prevention of flea infestations, and the treatment and control of tick infestations for 1 month in dogs and puppies.
Original approval with concurrent therapy e.g., furosemide, etc. for the management of clinical signs of mild, moderate, or severe congestive heart failure in dogs due to atrioventricular valvular insufficiency AVVI.
Original approval as a generic copy of NADA 141111.
Carprofen Tablets
Dogs
Original approval as a generic copy of NADA 140035.
FOI Summary.
MAXIBAN naracin and nicarbazin plus PENNITRACIN MD
bacitracin methylenedisalicylate Type C medicated feeds.
ZOASHIELD 25%
zoalene Type A medicated article.
OVACYST gonadorelin Injectable Solution.
Chickens
Original approval for increased rate of weight gain, improved feed efficiency, and for the prevention of coccidiosis in broiler chickens.
FOI Summary.
Chickens, turkeys.
Original approval as a generic copy of NADA 141218.
FOI Summary.
Cattle
Supplemental approval for fixed-time artificial insemination FTAI in beef cows and lactating dairy cows.
FOI Summary.
Approval date
File No.
July 9, 2020
141532
Intervet, Inc., 2 Giralda Farms, Madison, NJ
07940.
July 27, 2020
141538
July 29, 2020
200687
August 4, 2020
200681
September 9, 2020
141529
September 18, 2020.
200690
September 28, 2020.
200069
VerDate Sep<11>2014
Sponsor
Pharmasone LLC, 1800
Sir Tyler Dr., Wilmington, NC 28405.
Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland.
16:22 Mar 18, 2021
Jkt 253001
PO 00000
Product name
Frm 00009
Fmt 4700
Sfmt 4700
E:FRFM19MRR1.SGM
19MRR1
FOI Summary.
FOI Summary.
