[Federal Register Volume 87, Number 198 (Friday, October 14, 2022)]
[Notices]
[Pages 62419-62421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22335]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2335]
Prescription Drug User Fee Act VII; Independent Assessment of
Communication Through Product Quality Information Requests During
Application Review; Statement of Work; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the Statement of Work to assess
communication between FDA and sponsors through product quality
information requests during application review and to identify best
practices and areas of improvement. The independent assessment is part
of FDA performance commitments under the recent reauthorization of the
Prescription Drug User Fee Act (PDUFA). The independent assessment of
FDA and sponsors in communicating through product quality information
requests is described in detail 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, the assessment will be conducted by an
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independent contractor. FDA is providing for public comment on the
statement of work before revising as needed and requesting contractor
proposals.
DATES: Either electronic or written comments on the statement of work
must be submitted by November 14, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 14, 2022. 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:
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-2022-N-2335 for ``Prescription Drug User Fee Act VII Commitment to
Assess Current Practices of the Food and Drug Administration and
Sponsors in Communicating 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
https://www.regulations.gov or at the 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.'' FDA 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: Emily Ewing, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1148, Silver Spring, MD 20993-0002, 240-
402-0196, [email protected].
SUPPLEMENTARY INFORMATION: 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 reauthorization of PDUFA for the next 5-year
period (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 https://www.fda.gov/media/151712/download, 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 sponsors during
application review.
FDA and sponsors 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
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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.
IRs from both CDER and CBER are expected to follow Four-Part
Harmony in which reviewers are expected to communicate: (1) what was
provided, (2) what is the issue or deficiency, (3) what is needed, and
(4) why it is needed. This expectation can be found in CDER's Manual of
Policies and Procedures (MAPP) 5016.8, ``Communication Guidelines for
Quality-Related Information Requests and Deficiencies.'' As a result of
FDA's implementation of Four-Part Harmony in CMC-IRs, sponsors should
understand what information FDA needs to continue their review. The
PDUFA VII goals letter includes commitments for FDA to update and
conduct training on existing policies and procedures (MAPPs and
Standard Operating Policy and Procedure (SOPPs)), to reflect Four-Part
Harmony. CDER MAPP 5016.8, ``Communication Guidelines for Quality-
Related Information Requests and Deficiencies'' will be revised and
made public. CBER SOPP 8401.1, ``Issuance of and Review of Responses to
Information Request Communications to Pending Applications'' will also
be revised.
In addition to updating the documents and conducting training, FDA
is committed to contracting with an independent third party to assess
current practices of CDER, CBER, and sponsors in communicating through
product quality IRs during application review and effectiveness of
Four-Part Harmony. This assessment will identify best practices and
areas of improvement in communications between FDA review staff and
sponsors through product quality IRs and is the subject of this task
order.
The Statement of Work can be accessed at: https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-assessment-fda-and-sponsor-communications-through-product-quality-information-requests.
Dated: October 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22335 Filed 10-13-22; 8:45 am]
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