
[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)]
[Notices]
[Pages 63775-63776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22339]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-D-0045]


Waivers From the Requirement To Demonstrate Bioequivalence of 
Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A 
Medicated Articles; Draft Revised Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft revised guidance for industry (GFI) #171 
entitled ``Waivers from the Requirement to Demonstrate Bioequivalence 
of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A 
Medicated Articles.'' This draft revised guidance document describes 
how the Center for Veterinary Medicine (CVM) intends to evaluate 
requests for waiving the requirement for submitting data demonstrating 
the bioequivalence of animal drugs in soluble powder oral dosage form 
products and Type A medicated articles. It expands upon CVM's 
Bioequivalence Guidance,\1\ particularly the section on Criteria for 
Waiver of In Vivo Bioequivalence Study. This guidance is applicable to 
generic investigational new animal drug (JINAD) files and abbreviated 
new animal drug applications (ANADAs). Although the recommendations in 
this guidance reference generic drug applications, the general 
principles described may also be applicable to new animal drug 
applications (NADAs), investigational new animal drug (INAD) files, and 
supplemental NADAs.
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    \1\ CVM Guidance for Industry #35, ``Bioequivalence Guidance,'' 
November 8, 2006 (see page 7): http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052363.pdf.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft revised guidance before it begins work on the final version of 
the guidance, submit either electronic or written comments on the draft 
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revised guidance by November 15, 2016.

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-2004-D-0045 for ``Waivers from the Requirement to Demonstrate 
Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form 
Products and Type A Medicated Articles.'' 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

[[Page 63776]]

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 draft revised guidance document.

FOR FURTHER INFORMATION CONTACT: Charli Long, Center for Veterinary 
Medicine (HFV-170), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0850, charli.long-medrano@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft revised guidance for 
industry #171 entitled ``Waivers from the Requirement to Demonstrate 
Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form 
Products and Type A Medicated Articles.'' This draft revised guidance 
document describes how the Center for Veterinary Medicine (CVM) intends 
to evaluate requests for waiving the requirement for submitting data 
demonstrating the bioequivalence of animal drugs in soluble powder oral 
dosage form products and Type A medicated articles. It expands upon 
CVM's Bioequivalence Guidance,\2\ particularly the section on Criteria 
for Waiver of In Vivo Bioequivalence Study. This draft revised guidance 
document is intended to provide clarification of the scientific basis 
for concepts and recommendations conveyed in the original guidance. In 
addition, the table containing estimated gastric volumes for each of 
the various animal species has been revised. However, applicants may 
propose an alternative gastric volume value for a particular species 
when using the dosage adjusted approach. No new concepts have been 
introduced in this draft revised guidance and its scope has not been 
modified.
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    \2\ CVM Guidance for Industry #35, ``Bioequivalence Guidance,'' 
November 8, 2006 (see page 7): http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052363.pdf.
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II. Significance of Guidance

    This level 1 draft revised guidance is being issued consistent with 
FDA's good guidance practices regulation (21 CFR 10.115). The draft 
revised guidance, when finalized, will represent the current thinking 
of FDA on ``Waivers from the Requirement to Demonstrate Bioequivalence 
of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A 
Medicated Articles.'' It does not establish any rights for any person 
and is not binding on FDA or the public. You can use an alternative 
approach if it satisfies the requirements of the applicable statutes 
and regulations.

III. Paperwork Reduction Act of 1995

    This draft revised guidance refers to previously approved 
collections of information that are subject to review by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520). The collections of information referred to in 
the guidance entitled ``Waivers from the Requirement to Demonstrate 
Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form 
Products and Type A Medicated Articles'' have been approved under OMB 
control number 0910-0575.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft revised 
guidance at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: September 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22339 Filed 9-15-16; 8:45 am]
 BILLING CODE 4164-01-P


