Document ID: FDA-2015-N-0684-0010
Agency: fda
Document Type: Notice
Title: Identification of Alternative In Vitro Bioequivalence Pathways Which Can
Reliably Ensure In Vivo Bioequivalence of Product Performance and Quality of Non-Systemically Absorbed Drug Products for Animals; Reopening of the Comment Period
Posted Date: 2015-06-10T04:00Z

[Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)]
[Notices]
[Page 32963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14101]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0684]

Identification of Alternative In Vitro Bioequivalence Pathways 
Which Can Reliably Ensure In Vivo Bioequivalence of Product Performance 
and Quality of Non-Systemically Absorbed Drug Products for Animals; 
Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Request for comments; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period related to the use of in vitro methods as a mechanism 
for assessing the in vivo product bioequivalence (BE) of 
nonsystemically absorbed drug products intended for use in veterinary 
species, published in the Federal Register of March 18, 2015 (80 FR 
14146). FDA is reopening the comment period to update comments and to 
receive any new information.

DATES: Submit either electronic or written comments by August 10, 2015.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: John Harshman, Center for Veterinary 
Medicine, Food and Drug Administration, HFV-170, MPN2, 7500 Standish 
Pl., Rockville, MD 20855, 240-402-0845.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of March 18, 2015 (80 FR 14146), FDA 
announced a public meeting to discuss the use of in vitro methods as a 
mechanism for assessing the in vivo product bioequivalence (BE) of 
nonsystemically absorbed drug products intended for use in veterinary 
species. In the same notice, FDA said that it is seeking additional 
public comment to the docket. Interested persons were originally given 
until May 18, 2015, to comment on this issue.

II. Request for Comments

    Following publication of the March 18, 2015, notification of public 
meeting and request for comments, FDA received a request to allow 
interested persons additional time to comment. The requester asserted 
that the time period of 60 days was insufficient to respond fully to 
FDA's specific requests for comments and to allow potential respondents 
to thoroughly evaluate and address pertinent issues.

III. How To Submit Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: June 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14101 Filed 6-9-15; 8:45 am]
 BILLING CODE 4164-01-P