Document ID: FDA-2023-D-1275-0004
Agency: fda
Document Type: Notice
Title: Demonstrating Bioequivalence for Type A Medicated Articles Containing
Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in
Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are
Locally Acting; Draft Guidance for Industry; Availability; Reopening of the
Comment Period
Posted Date: 2023-08-16T04:00Z

[Federal Register Volume 88, Number 157 (Wednesday, August 16, 2023)]
[Notices]
[Pages 55702-55703]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17507]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-1275]

Demonstrating Bioequivalence for Type A Medicated Articles 
Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly 
Soluble in Aqueous Media, That Exhibit Little to No Systemic 
Bioavailability, and Are Locally Acting; Draft Guidance for Industry; 
Availability; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reopening the comment period for the notice of availability that 
published in the Federal Register of June 8, 2023. In that notice, FDA 
requested comments on the draft guidance for industry (GFI) #279 
entitled ``Demonstrating Bioequivalence for Type A Medicated Articles 
Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly 
Soluble in Aqueous Media, That Exhibit Little to No Systemic 
Bioavailability, and Are Locally Acting.'' The Agency is taking this 
action in response to a request for an extension to allow interested 
persons additional time to develop and submit comments.

DATES: FDA is reopening the comment period on the notice of 
availability published June 8, 2023 (88 FR 37551). Submit either 
electronic or written comments on the draft guidance by October 16, 
2023 to ensure that the Agency considers your comments on this draft 
guidance before it begins work on the final version of the guidance.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-2023-D-1275 for ``Demonstrating Bioequivalence for Type A Medicated 
Articles Containing Active Pharmaceutical Ingredient(s) Considered To 
Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic 
Bioavailability, and Are Locally Acting.'' 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

[[Page 55703]]

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.

FOR FURTHER INFORMATION CONTACT: Ian Hendricks, Center for Veterinary 
Medicine (HFV-172), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-5661, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of June 8, 2023 (88 
FR 37551), FDA published a notice announcing the availability of draft 
GFI #279 entitled ``Demonstrating Bioequivalence for Type A Medicated 
Articles Containing Active Pharmaceutical Ingredient(s) Considered To 
Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic 
Bioavailability, and Are Locally Acting.'' Interested persons were 
originally given until August 7, 2023, to comment on the draft 
guidance.
    The Agency received a request for a 60-day extension of the comment 
period for the draft guidance. The requestor indicated they needed more 
time to complete development of comments to submit in response to the 
draft guidance. FDA has considered the request and is reopening the 
comment period for the draft guidance for 60 days, until October 16, 
2023. The Agency believes that a 60-day reopening of the comment period 
allows adequate time for interested persons to submit comments to 
ensure that the Agency can consider the comments on this draft guidance 
before it begins work on the final version of the guidance.

    Dated: August 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17507 Filed 8-15-23; 8:45 am]
BILLING CODE 4164-01-P