Document ID: FDA-2019-D-3764-0003
Agency: fda
Document Type: Notice
Title: Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated 
Articles Containing Active Pharmaceutical Ingredients Considered To Be Soluble in Aqueous Media; Guidance for Industry; Availability
Posted Date: 2021-05-21T04:00Z

[Federal Register Volume 86, Number 97 (Friday, May 21, 2021)]
[Notices]
[Pages 27633-27635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10756]

-----------------------------------------------------------------------

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 Containing Active Pharmaceutical 
Ingredients Considered To Be Soluble in Aqueous Media; Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the availability of a final guidance for industry (GFI) #171 
entitled ``Demonstrating Bioequivalence for Soluble Powder Oral Dosage 
Form Products and Type A Medicated Articles Containing Active 
Pharmaceutical Ingredients Considered To Be Soluble in Aqueous Media.'' 
This 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: The announcement of the guidance is published in the Federal 
Register on May 21, 2021.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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'').

[[Page 27634]]

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 Containing 
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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    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, 7500 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: 
     Biopharmaceutics and Pharmacokinetics: Marilyn Martinez, 
Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 
7500 Standish Pl., Rockville, MD 20855, 240-402-0635, 
Marilyn.Martinez@fda.hhs.gov.
     Manufacturing Chemistry: Catherine Finnegan, Center for 
Veterinary Medicine (HFV-147), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-0650, 
Catherine.Finnegan@fda.hhs.gov.
     Generic Drug Approval Requirements/Solubility Concerns: 
Ian S. Hendricks, Center for Veterinary Medicine (HFV-172), Food and 
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-
0853, Ian.Hendricks@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 30, 2019 (84 FR 51595), FDA 
published the notice of availability for a draft guidance entitled 
``Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form 
Products and Type A Medicated Articles Containing Active Pharmaceutical 
Ingredients Considered to be Soluble in Aqueous Media'' giving 
interested persons until November 29, 2019, to comment on the draft 
guidance. This 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 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 APIs considered to be 
soluble in aqueous media. This guidance offers particular focus on 
criteria for the waiver of the requirements for submitting in vivo 
bioequivalence study data.
    This 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 guidance does 
not address Type A medicated articles manufactured from APIs considered 
to be insoluble in aqueous media.
    FDA received no comments on the draft guidance. The Agency made a 
minor change to the title of the guidance and other minor editorial 
changes to improve clarity. The guidance announced in this notice 
finalizes the draft guidance dated September 30, 2019.
    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the current thinking of FDA on ``Demonstrating Bioequivalence for 
Soluble Powder Oral Dosage Form Products and Type A Medicated Articles 
Containing 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.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in section 512(n)(1) of the Federal Food, Drug, and 
Cosmetic Act

[[Page 27635]]

(21 U.S.C. 360b(n)(1)) have been approved under OMB control number 
0910-0669.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry or https://www.regulations.gov.

    Dated: May 17, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10756 Filed 5-20-21; 8:45 am]
BILLING CODE 4164-01-P