Notice2025-08208
Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Final Report; Availability; Request for Comments
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
May 9, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled "Product Quality Information Request Communications Assessment: Final Report." This report fulfills a commitment under the recent reauthorization of the Prescription Drug User Fee Act (PDUFA) to assess communication between FDA and applicants through product quality information requests during application review and to identify best practices and areas of improvement. The assessment of FDA and applicants in communicating through product quality information requests was conducted by an independent contractor, as described in the document entitled "PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027." As part of FDA performance commitments described in this document, FDA is publishing the final assessment report and soliciting public comments.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 89 (Friday, May 9, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 89 (Friday, May 9, 2025)]
[Notices]
[Pages 19722-19724]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08208]
-----------------------------------------------------------------------
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; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a document entitled ``Product Quality Information
Request Communications Assessment: Final Report.'' This report fulfills
a commitment under the recent reauthorization of the Prescription Drug
User Fee Act (PDUFA) to assess communication between FDA and applicants
through product quality information requests during application review
and to identify best practices and areas of improvement. The assessment
of FDA and applicants in communicating through product quality
information requests was conducted by an independent contractor, as
described in the document entitled ``PDUFA Reauthorization Performance
Goals and Procedures Fiscal Years 2023 Through 2027.'' As part of FDA
performance commitments described in this document, FDA is publishing
the final assessment report and soliciting public comments.
DATES: Submit either electronic or written comments on the final report
by July 31, 2025.
ADDRESSES: You may submit either electronic or written comments 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
[[Page 19723]]
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 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#f3be929b96809bdda1929e929d92979b929eb3959792dd9b9b80dd949c85"><span class="__cf_email__" data-cfemail="a7eac6cfc2d4cf89f5c6cac6c9c6c3cfc6cae7c1c3c689cfcfd489c0c8d1">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
PDUFA provides FDA with a source of stable, consistent funding that
has made it possible for the Agency to focus on promoting innovative
therapies and help bring to market critical products for patients. When
PDUFA was originally authorized in 1992, it had a 5-year term. The
program has been subsequently reauthorized every 5 years. To prepare
for the reauthorization of PDUFA for years 2023 to 2027, FDA conducted
negotiations with the regulated industry and held regular consultations
with public stakeholders, including patient advocates, consumer
advocates, and healthcare professionals between September 2020 and
February 2021.
Following these discussions, related public meetings, and Agency
requests for public comment, FDA published the ``PDUFA Reauthorization
Performance Goals and Procedures Fiscal Years 2023 Through 2027''
document, available at <a href="https://www.fda.gov/media/151712/download">https://www.fda.gov/media/151712/download</a>, also
known as the PDUFA VII ``goals letter,'' to supplement the statute. The
goals letter includes the performance goals, procedures, and
commitments that apply to aspects of the human drug review program that
are important for facilitating timely access to safe, effective, and
innovative new medicines for patients. Several of these commitments aim
to continue to enhance communication between FDA and applicants during
application review.
FDA and applicants interact in a variety of ways throughout
application review. One such way is via a communication called an
information request (IR), sent to an applicant as the discipline review
occurs. FDA uses IRs to request further information or clarification
that is needed or would be helpful to allow completion of the
discipline review. IRs may be in the form of letters, emails, or faxes.
FDA uses product quality IRs to request further information or
clarification needed for FDA's assessment of identity, strength,
quality, purity, or potency of drug substances or drug products.
Ensuring that patients can have confidence in the safety and
effectiveness of their medications is a longstanding priority for FDA.
The Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER) have worked to address this
priority in part by performing Chemistry, Manufacturing, and Controls
(CMC) reviews for CDER-regulated and CBER-regulated products. CDER or
CBER may issue a product quality, or CMC, IR as a result of CMC
assessments conducted in support of the application.
CDER and CBER have established procedures for assessors to use
Four-Part Harmony, a framework that describes four key elements that
should be included in product quality IRs, specifically: (1) what was
provided, (2) what is the issue or deficiency, (3) what is needed, and
(4) why it is needed. These procedures can be found in CDER's Manual of
Policies and Procedures (MAPP) 5016.8 Rev. 1, ``Using Four-Part Harmony
in Quality-Related Assessment Communications'' and CBER's Standard
Operating Procedures and Policies (SOPP) 8401.1, ``Issuance of and
Review of Responses to Information Request Communications to Pending
Applications.'' The PDUFA VII goals letter includes commitments for FDA
to update and conduct training on existing policies and procedures
(MAPPs and SOPPs), to reflect Four-Part Harmony. CDER MAPP 5016.8,
``Communication Guidelines for Quality-Related Information Requests and
Deficiencies'' (<a href="https://www.fda.gov/media/171613/download">https://www.fda.gov/media/171613/download</a>) was revised
in September 2023 and made public. CBER SOPP 8401.1, ``Issuance of and
Review of Responses to Information Request Communications to Pending
Applications'' (<a href="https://www.fda.gov/media/85301/download">https://www.fda.gov/media/85301/download</a>) was revised
in October 2022.
In addition to updating the documents and conducting training, FDA
committed to contracting with an independent third party to assess
current practices of CDER, CBER, and applicants in communicating
through product quality IRs during application review and effectiveness
of Four-Part Harmony. This assessment has been completed, and in
accordance with the PDUFA VII goals letter, FDA is seeking public
comment on this ``Product Quality Information Request Communications
Assessment: Final Report,'' available at <a href="https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-assessment-fda-and-sponsor-communications-through-product-quality-information-requests">https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-assessment-fda-and-sponsor-communications-through-product-quality-information-requests</a>.
[[Page 19724]]
II. Request for Comments
FDA is soliciting comments on the ``Product Quality Information
Request Communications Assessment: Final Report'' from interested
parties. We request 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.
III. Electronic Access
Persons with access to the internet may obtain the report at
<a href="https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-assessment-fda-and-sponsor-communications-through-product-quality-information-requests">https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-assessment-fda-and-sponsor-communications-through-product-quality-information-requests</a>.
Dated: May 6, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-08208 Filed 5-8-25; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on May 9, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.