Notice2025-14684
Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Final Report; Availability; Reopening of Comment Period
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 4, 2025
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 entitled "Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Final Report; Availability; Request for Comments" that appeared in the Federal Register of May 9, 2025. In the notice of availability, FDA requested comments on the final assessment report. The Agency is taking this action in response to a request to allow interested persons additional time to submit comments.
Full Text
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<title>Federal Register, Volume 90 Issue 147 (Monday, August 4, 2025)</title>
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[Federal Register Volume 90, Number 147 (Monday, August 4, 2025)]
[Notices]
[Pages 36443-36444]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14684]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1090]
Prescription Drug User Fee Act VII; Independent Assessment of
Communication Through Product Quality Information Requests During
Application Review; Final Report; Availability; Reopening of Comment
Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; reopening of 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 entitled
``Prescription Drug User Fee Act VII; Independent Assessment of
Communication Through Product Quality Information Requests During
Application Review; Final Report; Availability; Request for Comments''
that appeared in the Federal Register of May 9, 2025. In the notice of
availability, FDA requested comments on the final assessment report.
The Agency is taking this action in response to a request to allow
interested persons additional time to submit comments.
DATES: FDA is reopening the comment period on the final report
published May 9, 2025 (90 FR 19722). Either electronic or written
comments must be submitted by September 3, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 30, 2025. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
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,
[[Page 36444]]
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-2025-N-1090 for ``Independent Assessment of Communication Through
Product Quality Information Requests During Application Review.''
Received comments, those filed in a timely manner (see ADDRESSES), 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 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: Mahesh Ramanadham, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3272, email:
<a href="/cdn-cgi/l/email-protection#d79ab6bfb2a4bff985b6bab6b9b6b3bfb6ba97b1b3b6f9bfbfa4f9b0b8a1"><span class="__cf_email__" data-cfemail="df92beb7baacb7f18dbeb2beb1bebbb7beb29fb9bbbef1b7b7acf1b8b0a9">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 9, 2025, FDA
published a notice of availability with a 30-day comment period to
request comments on the document entitled ``Product Quality Information
Request Communications Assessment: Final Report.'' FDA requested
feedback on: (1) the assessment findings and recommendations, (2)
whether certain recommendations are more desirable than others, and (3)
other actions FDA and applicants should consider and why.
The Agency has received a request for a 30-day extension of the
comment period for the notice of availability. The request conveyed
concern that the current 30-day comment period does not allow
sufficient time to develop a thoughtful, substantive response to the
notice of availability.
FDA has considered the request and is reopening the comment period
for the notice of availability for 30 days, until September 3, 2025.
The Agency believes that the additional 30-days allow adequate time for
interested persons to submit comments.
Dated: July 30, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14684 Filed 8-1-25; 8:45 am]
BILLING CODE 4164-01-P
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