[Federal Register Volume 88, Number 7 (Wednesday, January 11, 2023)]
[Notices]
[Pages 1597-1599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00389]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1203]
Prescription Drug User Fee Act of 2023 VII Meetings Program for
Model-Informed Drug Development Approaches
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The seventh iteration of the Prescription Drug User Fee Act
(PDUFA VII), incorporated as part of the FDA User Fee Reauthorization
Act of 2022, highlights the goal of advancing model-informed drug
development (MIDD). The Food and Drug Administration (FDA or Agency) is
announcing the continuation of the MIDD Paired Meeting Program that
affords sponsors who are selected for participation the opportunity to
meet with Agency staff to discuss MIDD approaches in medical product
development. Meetings under the program will be conducted by FDA's
Center for Drug Evaluation and Research (CDER) and Center for Biologics
Evaluation and Research (CBER) during fiscal years 2023-2027. This
program is being conducted to fulfill FDA's performance commitment
under PDUFA VII. For this program, MIDD is defined as the application
of exposure-based, biological, and/or statistical models derived from
non-clinical and clinical data sources to address drug development and/
or regulatory issues (see Supplementary Information, I. Background, and
II. Eligibility and Selection for Participation of this notice). For
each approved proposal, the program consists of two meetings between
sponsors or applicants and the relevant center that provide an
opportunity for drug developers and FDA to discuss the application of
MIDD approaches to the development and regulatory evaluation of medical
products in development.
DATES: FDA will accept requests to participate in the program on a
continuous basis beginning on October
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1, 2022, through June 1, 2027. See section III of this notice for
instructions about how to request participation in the program.
Meeting-granted and -denied decisions will be made the last 2 weeks of
each quarter of the fiscal year based on submissions received to date.
Requesters will receive a meeting-granted or -denied notification no
later than the second week of the new quarter.
The program will proceed from October 1, 2022, through September
30, 2027. The Agency will notify sponsors of proposals not selected for
a given quarter. Sponsors who do not participate in the program may
seek Agency interaction through existing channels (e.g., Type C meeting
requests, critical path innovation meetings). The listed eligibility
criteria and procedures outlined in this Federal Register notice
reflect the current thinking at the time of publication. Processes may
be revised and will be communicated as this program evolves. The most
current program eligibility criteria and procedures may be found on the
MIDD Program website: https://www.fda.gov/drugs/development-resources/model-informed-drug-development-paired-meeting-program.
ADDRESSES: Comments about this program can be submitted until February
10, 2023. You may submit comments about the MIDD meetings program 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-2018-N-1203 for ``Prescription Drug User Fee Act of 2023 VII
Meetings Program for Model-Informed Drug Development Approaches.''
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 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:
CDER: Yvonne Knight, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2142,
Silver Spring, MD 20993, 301-796-2133, [email protected] with
the subject line ``MIDD Meetings Program for CDER.''
CBER: Christopher Egelebo, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 5340, Silver Spring, MD 20993, 240-402-8625,
[email protected] with the subject line ``MIDD Meetings
Program for CBER.''
SUPPLEMENTARY INFORMATION:
I. Background
Under the FDA User Fee Reauthorization Act of 2022, FDA agreed, in
accordance with the ``PDUFA Reauthorization Performance Goals and
Procedures Fiscal Years 2023 Through 2027: I. Ensuring the
Effectiveness of the Human Drug Review, Part L. Enhancing Regulatory
Decision Tools to Support Drug Development and Review'' to provide
information on how a sponsor can apply to participate in the MIDD
Meetings Program (https://www.fda.gov/media/151712/download).
FDA will build on the success of the MIDD Paired Meeting Pilot
under PDUFA VI by continuing to advance and integrate the development
and application of exposure-based, biological, and statistical models
derived from non-clinical and clinical data sources in drug development
and regulatory review. FDA is announcing the continuation of this
meeting program to satisfy the above-mentioned commitment and to
facilitate the continued use of MIDD approaches. These approaches
exclude statistical designs involving complex adaptations, Bayesian
methods, or other features requiring computer simulations to determine
the operating characteristics of a confirmatory clinical trial. MIDD
approaches use a variety of quantitative methods to help balance the
risks and benefits of drug products in development. When successfully
applied, MIDD approaches can improve clinical trial efficiency,
increase the probability of regulatory success, and optimize drug
dosing/therapeutic individualization in the absence of dedicated
trials.
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The goal of the early meeting discussions granted under this
program is to provide advice on how specific, proposed MIDD approaches
can be used in a particular drug development program. FDA has committed
to accepting one to two appropriate meeting requests quarterly each
fiscal year. The meetings granted will include an initial and followup
meeting on the same drug development issues. The second meeting will
occur within approximately 60 days of receiving the briefing package.
II. Eligibility and Selection for Participation in the MIDD Program
The sponsor should be a drug/biologics development company
(interested consortia or software/device developer should come in
partnership with a drug development company) and have an
investigational new drug application (IND) or pre-IND (PIND) number for
the relevant program. FDA welcomes submissions related to any relevant
MIDD topics, such as:
Dose selection or estimation (e.g., for dose/dosing
regimen selection or refinement)
Clinical trial simulation (e.g., based on drug-trial-
disease models to inform the duration of a trial, select appropriate
response measures, predict outcomes, etc.)
Predictive or mechanistic safety evaluation (e.g., use of
systems pharmacology/mechanistic models for predicting safety or
identifying critical biomarkers of interest)
III. Procedures and Submission Information
A. General Information
The MIDD program will be jointly administered by CDER's Office of
Clinical Pharmacology, in the Office of Translational Sciences, which
is the point of contact for all communications for CDER products, and
CBER's Office of Biostatistics and Pharmacovigilance, which is the
point of contact for all communications for CBER products.
B. How To Submit a Meeting Request and Meeting Package
Meeting requests should be submitted electronically to the relevant
application (i.e., PIND, IND) with ``MIDD Program Meeting Request for
CDER'' (CDER applications) or ``MIDD Program Meeting Request for CBER''
(CBER applications) in the subject line. Information about providing
regulatory submissions in electronic format is available at: https://www.fda.gov/drugs/development-approval-process-drugs/forms-submission-requirements.
C. Content and Format of the Meeting Request
Include the following information in the meeting request (no more
than three to four pages):
1. Product name.
2. Application number.
3. Chemical name and structure.
4. Proposed indication(s) or context of product development.
5. A brief statement of the purpose and objectives of the meeting.
The statement should include a brief background of the MIDD issues
underlying the agenda.
6. MIDD approach(es) considered for the product under development
and how MIDD can assess uncertainties about issues (e.g., dosing,
duration, patient selection) in a way that can inform regulatory
decision-making.
7. A list of issues for discussion with the Agency about the
specific MIDD proposed approach for the applicable drug development
program.
D. Content and Format of the Meeting Information Package
Sponsors whose meeting requests are granted as part of the program
should submit a meeting information package electronically with ``MIDD
Program Meeting Package for CDER'' (CDER applications) or ``MIDD
Program Meeting Package for CBER'' (CBER applications) in the subject
line no later than 47 days before the initial meeting and 60 days
before the follow-up meeting. This meeting package should include the
following information:
1. Product name.
2. Application number.
3. Chemical name and structure.
4. Proposed indications or context of product development.
5. Background section that includes a brief history of the
development program and the events leading up to the meeting as well as
the status of product development.
6. Proposed agenda, including estimated times needed for discussion
of each agenda item.
7. List of questions for discussion along with a brief summary
explaining the question of interest and the context of use for each
question. State whether the model will be used to inform future trials,
to provide mechanistic insight, or in lieu of a clinical trial.
8. The drug development issue (e.g., dosing, clinical trial design,
safety prediction, etc.), the proposed MIDD approach to the solution,
information to support discussion (e.g., a description of the data
utilized for developing the models, model development, simulation plan,
results), assessment of model risk, and how the Agency can help guide
any next steps relative to the regulatory decision-making process
should be summarized and clearly articulated with any supporting data
imperative to the discussion.
E. Meeting Summaries
A meeting summary will be sent to the requester within 30 days of
each meeting.
IV. Paperwork Reduction Act of 1995
While this notice contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this notice. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information pertaining to Prescription Drug User Fee Program have
been approved under OMB control number 0910-0297. The collections of
information for requesting meetings with FDA about drug development
programs have been approved under OMB control number 0910-0001. The
collections of information in 21 CFR part 312 for INDs and clinical
trials have been approved under OMB control number 0910-0014. The
collections of information in 21 CFR part 601 for biologics license
applications have been approved under OMB control number 0910-0338.
Dated: January 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00389 Filed 1-10-23; 8:45 am]
BILLING CODE 4164-01-P