[Federal Register Volume 84, Number 189 (Monday, September 30, 2019)]
[Notices]
[Pages 51595-51597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21202]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3764]


Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form 
Products and Type A Medicated Articles Manufactured From Active 
Pharmaceutical Ingredients Considered To Be Soluble in Aqueous Media; 
Draft Guidance for Industry; Availability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, we, or Agency) is

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announcing the availability of a draft guidance for industry (GFI) #171 
entitled ``Demonstrating Bioequivalence for Soluble Powder Oral Dosage 
Form Products and Type A Medicated Articles Manufactured from Active 
Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media.'' 
This draft guidance describes how the Agency intends to evaluate 
requests for waiving the requirement for performing in vivo 
bioequivalence studies for animal drugs administered orally as soluble 
powders or as Type A medicated articles manufactured from active 
pharmaceutical ingredients considered to be soluble in aqueous media.

DATES: Submit either electronic or written comments on the draft 
guidance by November 29, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2019-D-3764 for ``Demonstrating Bioequivalence for Soluble Powder 
Oral Dosage Form Products and Type A Medicated Articles Manufactured 
from Active Pharmaceutical Ingredients Considered to be Soluble in 
Aqueous Media.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 guidance document.

FOR FURTHER INFORMATION CONTACT: 
     Biopharmaceutics and Pharmacokinetics: Marilyn Martinez, 
Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 
7500 Standish Pl., Rockville, MD 20855, 240-402-0635, 
[email protected].
     Manufacturing Chemistry/Solubility Concerns: Catherine 
Finnegan, Center for Veterinary Medicine (HFV-147), Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0650, 
[email protected].
     Generic Drug Approval Requirements: Ian S. Hendricks, 
Center for Veterinary Medicine (HFV-172), Food and Drug Administration, 
7500 Standish Pl., Rockville, MD 20855, 240-402-0853, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft GFI #171 entitled 
``Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form 
Products and Type A Medicated Articles Manufactured from Active 
Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media.'' 
This draft guidance describes how the Agency intends to evaluate 
requests for waiving the requirement for performing in vivo 
bioequivalence studies (biowaivers) for animal drugs administered 
orally as soluble powders or as Type A medicated articles manufactured 
from active pharmaceutical ingredients (APIs) considered to be soluble 
in aqueous media (water soluble APIs). This draft guidance expands upon 
GFI #35, ``Bioequivalence Guidance,'' published November 8, 2006, to 
include biowaivers for soluble powder oral dosage form products as well 
as Type A medicated articles manufactured from active pharmaceutical 
ingredients considered to be soluble in aqueous media. This draft 
guidance offers particular focus on criteria for the waiver of the 
requirements for

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submitting in vivo bioequivalence study data.
    This draft guidance is applicable to generic investigational new 
animal drug (JINAD) files and to abbreviated new animal drug 
applications (ANADAs). Although the recommendations in this guidance 
refer to 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. 
This draft guidance does not address Type A medicated articles 
manufactured from active pharmaceutical ingredients considered to be 
insoluble in aqueous media.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the current thinking of FDA on 
``Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form 
Products and Type A Medicated Articles Manufactured from Active 
Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media.'' 
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. This 
guidance is not subject to Executive Order 12866.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to collections of information associated 
with biowaiver requests for generic soluble powder oral dosage form 
products and Type A medicated articles. These collections of 
information 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 associated with biowaiver 
requests for generic soluble powder oral dosage form products and Type 
A medicated articles are being reviewed by OMB under OMB control number 
0910-0669 (see 84 FR 16270 at 16271, April 18, 2019).

IV. Electronic Access

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

    Dated: September 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21202 Filed 9-27-19; 8:45 am]
BILLING CODE 4164-01-P