Document ID: FDA-2015-N-0684-0012
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: 2015-10-02T04:00Z

[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Pages 59787-59788]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25121]

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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

[[Page 59788]]

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 receive new information.

DATES: Submit either electronic or written comments by November 2, 
2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-0684 for 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. 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the 
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, 
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: John Harshman, CVM, Food and Drug 
Administration, HFV-170, MPN2, 7500 Standish Place, 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 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. Following publication of 
that notice, FDA received a request to allow interested persons 
additional time to comment. In response to that request, FDA published 
a Federal Register notice on June 10, 2015, reopening the comment 
period for 60 days, until August 10, 2015.

II. Request for Comments

    Following publication of the June 10, 2015, notice reopening the 
comment period for 60 days, FDA received a request to allow interested 
persons an additional 30 days to comment. FDA has considered the 
request and is reopening the comment period for 30 days, until November 
2, 2015.

    Dated: September 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25121 Filed 10-1-15; 8:45 am]
 BILLING CODE 4164-01-P