Federal Register - March 8, 2021
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Fuente: Federal Register
13181
Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations Entity
License requirement
License review policy
Federal Register Citation
Myanmar Economic Corporation, a.k.a., the following one alias:
MEC.
Corner of Ahlone Road and Strand Road, Ahlone Township, Yangon, Myanmar.
Myanmar Economic Holdings Limited, a.k.a., the following eight aliases:
MEHL;
Myanma Economic Holdings Limited;
Myanma Economic Holdings Public Company Limited;
Myanmar Business Holdings Public Company Limited;
Myanmar Economic Holdings Public Company Limited;
UMEH;
Union of Myanmar Economic Holdings Company Limited; and Union of Myanmar Economic Holdings Limited.
189191
Maha Bandoola Road, Botahtaung Township, Yangon, Burma.
For all items subject to the EAR. See 744.11
of the EAR.
Presumption of denial
86 FR INSERT FR PAGE
NUMBER, 3/8/2021.
For all items subject to the EAR. See 744.11
of the EAR.
Presumption of denial
86 FR INSERT FR PAGE
NUMBER, 3/8/2021.
Country
Matthew S. Borman, Deputy Assistant Secretary for Export Administration.
21 CFR Parts 510, 516, 520, 522, 524, 526, 529, 556, and 558
reflect application-related actions for new animal drug applications NADAs and abbreviated new animal drug applications ANADAs during April, May, and June 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 8, 2021.
Docket No. FDA2020N0002
FOR FURTHER INFORMATION CONTACT:
FR Doc. 202104794 Filed 3421; 4:15 pm BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical amendments.
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:
ACTION:
I. Approval Actions
The Food and Drug Administration FDA or we is amending the animal drug regulations to
FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during April, May, and June 2020, as listed in table 1.
SUMMARY:
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 HFA305, 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.
TABLE 1ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING APRIL, MAY, AND JUNE 2020
jbell on DSKJLSW7X2PROD with RULES
Approval date
File No.
April 2, 2020
141527
April 10, 2020
141533
VerDate Sep<11>2014
Product name
Species
Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201.
Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096.
BAYTRIL 100CA1
enrofloxacin Injectable Solution.
Cattle
Conditional approval for the treatment of clinical anaplasmosis in certain classes of cattle.
FOI Summary.
ASERVO EQUIHALER
ciclesonide inhalation spray.
Horses
Original approval for the management of clinical signs associated with severe equine asthma in horses.
FOI Summary.
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Effect of the action
Public documents
Sponsor
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