[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Draft Guidance for Industry; Availability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announcing the availability of a draft guidance for industry (GFI) #171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This draft guidance describes how the Agency intends to evaluate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DATES: Submit either electronic or written comments on the draft
guidance by November 29, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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]
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