Notice2023-17507
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To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting; Draft Guidance for Industry; Availability; Reopening of the Comment Period
Primary source
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Published
August 16, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 In that notice, FDA requested comments on the draft guidance for industry (GFI) #279 entitled "Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be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.
Full Text
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[Federal Register Volume 88, Number 157 (Wednesday, August 16, 2023)]
[Notices]
[Pages 55702-55703]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17507]
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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Bioavailability, and Are Locally Acting; Draft Guidance for Industry;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.
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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requested comments on the draft guidance for industry (GFI) #279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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the
[[Page 55703]]
Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#cf86aea1e187aaa1abbda6aca4bc8fa9abaee1a7a7bce1a8a0b9"><span class="__cf_email__" data-cfemail="d990b8b7f791bcb7bdabb0bab2aa99bfbdb8f7b1b1aaf7beb6af">[email protected]</span></a>.
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
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