Pilot Meetings Program for Model-Informed Drug Development Approaches, 16868-16870 [2018-08010]
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16868
Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices
Committee
Blood Products Advisory Committee
National Center for Toxicological
Research:
Science Board to the National Center
for Toxicological Research
Center for Drug Evaluation and
Research:
Joint Meetings of the Anesthetic and
Analgesic Drug Products Advisory
Committee and the Drug Safety and
Risk Management Advisory
Committee
Drug Safety and Risk Management
Advisory Committee
Annual Reports are available for public
inspections between 9 a.m. and 4 p.m.,
Monday through Friday, at:
(1) The Library of Congress, Madison
Building, Newspaper and Current
Periodical Reading Room, 101
Independence Ave. SE, Rm. 133,
Washington, DC 20540; and
(2) Dockets Management Staff (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Dated: April 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07981 Filed 4–16–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1203]
Pilot Meetings Program for ModelInformed Drug Development
Approaches
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The sixth iteration of the
Prescription Drug User Fee Act (PDUFA
VI), incorporated as part of the FDA
Reauthorization Act of 2017 (FDARA),
highlights the goal of advancing modelinformed drug development (MIDD).
The Food and Drug Administration
(FDA or Agency) is announcing a pilot
program that affords sponsors or
applicants who are selected for
participation the opportunity to meet
with Agency staff to discuss MIDD
approaches in medical product
development. Meetings under the pilot
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 2018 to 2022. This pilot
program is being conducted to fulfill
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
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FDA’s performance commitment under
PDUFA VI. For this pilot program,
MIDD is defined as the application of
exposure-based, biological, and/or
statistical models derived from
preclinical 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 pilot program
consists of two meetings between
sponsors or applicants and the relevant
center and will 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 April 17,
2018 through June 15, 2022. See section
III of this notice for instructions about
how to request participation in the pilot
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 meetinggranted or -denied notification the first
week of the new quarter.
The pilot program meetings will begin
in Q4 of FY 2018 (July 1–September 30,
2018), and run through Q4 of FY 2022
(September 30, 2022). Proposals not
selected for a given quarter will be so
notified by the Agency. Sponsors who
are not chosen to participate in the pilot
program may seek Agency interaction
through existing channels (e.g., Type C
meeting requests, critical path
innovation meetings).
ADDRESSES: Comments about this pilot
program can be submitted until May 17,
2018. You may submit comments about
the MIDD pilot 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
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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 ‘‘Pilot 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.
• 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
E:\FR\FM\17APN1.SGM
17APN1
Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
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 20993–0002, 301–
796–2133, Yvonne.Knight@fda.hhs.gov,
with the subject line ‘‘MIDD Pilot
Meetings Program for CDER.’’
CBER: Jason Claeys, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
1223, Silver Spring, MD 20993–0002,
240–402–8589, jason.claeys@
fda.hhs.gov, with the subject line
‘‘MIDD Pilot Meetings Program for
CBER.’’
SUPPLEMENTARY INFORMATION:
daltland on DSKBBV9HB2PROD with NOTICES
I. Background
Under FDARA FDA agreed, in
accordance with the ‘‘PDUFA
Reauthorization Performance Goals and
Procedures Fiscal Years 2018 Through
2022: I. Ensuring the Effectiveness of the
Human Drug Review Program, Part J.
Enhancing Regulatory Decision Tools to
Support Drug Development and
Review’’ to provide information on how
a sponsor can apply to participate in a
pilot meetings program with FDA to
discuss MIDD approaches (https://
www.fda.gov/downloads/ForIndustry/
UserFees/PrescriptionDrugUserFee/
UCM511438.pdf).
FDA is announcing this pilot
meetings program to satisfy the abovementioned commitment and to facilitate
MIDD approaches. This excludes
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
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19:20 Apr 16, 2018
Jkt 244001
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.
The goal of the early meeting
discussions granted under this pilot
program is to provide advice on how
specific, proposed MIDD approaches
can be used in a specific drug
development program. FDA has
committed to accepting two to four
meeting requests quarterly each fiscal
year. The meetings granted will include
an initial and followup meeting on the
same drug development issues within
the span of approximately 120 days.
The listed eligibility factors 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 pilot program
evolves. The most current pilot program
eligibility factors and procedures may
be found on the MIDD Pilot Program
website: https://www.fda.gov/Drugs/
DevelopmentApprovalProcess/
DevelopmentResources/
ucm600311.htm.
II. Eligibility and Selection for
Participation in the MIDD Pilot
Program
The requester 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.
Recognizing that FDA will learn both
from the number and types of
submissions received for consideration
into the pilot program, FDA welcomes
submissions related to any relevant
MIDD topics. However, given that the
Agency expects to grant two to four
meeting requests per quarter as part of
the pilot program, the Agency will
initially prioritize selecting requests that
focus on:
• 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).
• Predictive or mechanistic safety
evaluation (e.g., use of systems
pharmacology/mechanistic models for
predicting safety or identifying critical
biomarkers of interest).
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16869
III. Procedures and Submission
Information
A. General Information
The MIDD pilot 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 Epidemiology, 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 Pilot
Program Meeting Request for CDER’’
(CDER applications) or ‘‘MIDD Pilot
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/
DevelopmentApprovalProcess/
FormsSubmissionRequirements/
%20ElectronicSubmissions/
ucm153574.htm.
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. 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. 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 or applicants whose meeting
requests are granted as part of the pilot
program should submit a meeting
information package electronically with
‘‘MIDD Pilot Program Meeting Package
for CDER’’ (CDER applications) or
‘‘MIDD Pilot Program Meeting Package
for CBER’’ (CBER applications) in the
subject line no later than 30 days before
each (initial and followup) meeting.
This meeting package should include
the following information:
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Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices
1. Product name.
2. Application number.
3. Chemical name and structure.
4. Proposed indication(s) 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, and the status of product
development.
6. Proposed agenda, including
estimated times needed for discussion
of each agenda item.
7. List of questions for discussion
with a brief summary for each question
to explain the need or context for the
question.
8. Drug development issue (e.g.,
dosing, clinical trial design, safety
prediction), including the proposed
MIDD approach to the solution,
information to support discussion (e.g.,
a description of the data used for
developing the models, model
development, simulation plan, results),
and how the Agency can help guide any
next steps relative to the regulatory
decision making process, which 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 60 days of each
meeting.
IV. Paperwork Reduction Act of 1995
This notice refers to collections of
information that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collection of information resulting from
formal meetings between sponsors or
applicants and FDA has been approved
under OMB control number 0910–0429.
The collection of information in 21 CFR
part 312 (INDs) has been approved
under OMB control number 0910–0014.
Dated: April 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–08010 Filed 4–16–18; 8:45 am]
daltland on DSKBBV9HB2PROD with NOTICES
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6931]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practices and Related
Regulations for Blood and Blood
Components; and Requirements for
Donation Testing, Donor Notification,
and ‘‘Lookback’’
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, we, or Agency) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 17,
2018.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0116. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Current Good Manufacturing Practices
and Related Regulations for Blood and
Blood Components; and Requirements
for Donation Testing, Donor
Notification, and ‘‘Lookback’’
OMB Control Number 0910–0116—
Extension
All blood and blood components
introduced or delivered for introduction
into interstate commerce are subject to
section 351(a) of the Public Health
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Service Act (PHS Act) (42 U.S.C.
262(a)). Section 351(a) requires that
manufacturers of biological products,
which include blood and blood
components intended for further
manufacturing into products, have a
license, issued upon a demonstration
that the product is safe, pure, and potent
and that the manufacturing
establishment meets all applicable
standards, including those prescribed in
the FDA regulations designed to ensure
the continued safety, purity, and
potency of the product. In addition,
under section 361 of the PHS Act (42
U.S.C. 264), by delegation from the
Secretary of Health and Human
Services, FDA may make and enforce
regulations necessary to prevent the
introduction, transmission, or spread of
communicable diseases from foreign
countries into the States or possessions,
or from one State or possession into any
other State or possession.
Section 351(j) of the PHS Act states
that the Federal Food, Drug, and
Cosmetic Act (FD&C Act) also applies to
biological products. Blood and blood
components for transfusion or for
further manufacturing into products are
drugs, as that term is defined in section
201(g)(1) of the FD&C Act (21 U.S.C.
321(g)(1)). Because blood and blood
components are drugs under the FD&C
Act, blood and plasma establishments
must comply with the provisions and
related regulatory scheme of the FD&C
Act. For example, under section 501 of
the FD&C Act (21 U.S.C. 351), drugs are
deemed ‘‘adulterated’’ if the methods
used in their manufacturing, processing,
packing, or holding do not conform to
current good manufacturing practice
(CGMP) and related regulations.
The CGMP regulations (part 606) (21
CFR part 606) and related regulations
implement FDA’s statutory authority to
ensure the safety, purity, and potency of
blood and blood components. The
public health objective in testing human
blood donations for evidence of relevant
transfusion-transmitted infections and
in notifying donors is to prevent the
transmission of relevant transfusiontransmitted infections. For example, the
‘‘lookback’’ requirements are intended
to help ensure the continued safety of
the blood supply by providing necessary
information to consignees of blood and
blood components and appropriate
notification of recipients of blood
components that are at increased risk for
transmitting human immunodeficiency
virus (HIV) or hepatitis C virus (HCV)
infection.
The information collection
requirements in the CGMP, donation
testing, donor notification, and
‘‘lookback’’ regulations provide FDA
E:\FR\FM\17APN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 74 (Tuesday, April 17, 2018)]
[Notices]
[Pages 16868-16870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08010]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1203]
Pilot Meetings Program for Model-Informed Drug Development
Approaches
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The sixth iteration of the Prescription Drug User Fee Act
(PDUFA VI), incorporated as part of the FDA Reauthorization Act of 2017
(FDARA), highlights the goal of advancing model-informed drug
development (MIDD). The Food and Drug Administration (FDA or Agency) is
announcing a pilot program that affords sponsors or applicants who are
selected for participation the opportunity to meet with Agency staff to
discuss MIDD approaches in medical product development. Meetings under
the pilot 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 2018 to 2022. This pilot program is being
conducted to fulfill FDA's performance commitment under PDUFA VI. For
this pilot program, MIDD is defined as the application of exposure-
based, biological, and/or statistical models derived from preclinical
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 pilot program consists of two meetings between
sponsors or applicants and the relevant center and will 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 April 17, 2018 through June 15, 2022. See
section III of this notice for instructions about how to request
participation in the pilot 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 the first week of the new
quarter.
The pilot program meetings will begin in Q4 of FY 2018 (July 1-
September 30, 2018), and run through Q4 of FY 2022 (September 30,
2022). Proposals not selected for a given quarter will be so notified
by the Agency. Sponsors who are not chosen to participate in the pilot
program may seek Agency interaction through existing channels (e.g.,
Type C meeting requests, critical path innovation meetings).
ADDRESSES: Comments about this pilot program can be submitted until May
17, 2018. You may submit comments about the MIDD pilot 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 ``Pilot 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.
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
[[Page 16869]]
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.gpo.gov/fdsys/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.
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 20993-0002, 301-796-2133, [email protected],
with the subject line ``MIDD Pilot Meetings Program for CDER.''
CBER: Jason Claeys, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
1223, Silver Spring, MD 20993-0002, 240-402-8589,
[email protected], with the subject line ``MIDD Pilot Meetings
Program for CBER.''
SUPPLEMENTARY INFORMATION:
I. Background
Under FDARA FDA agreed, in accordance with the ``PDUFA
Reauthorization Performance Goals and Procedures Fiscal Years 2018
Through 2022: I. Ensuring the Effectiveness of the Human Drug Review
Program, Part J. Enhancing Regulatory Decision Tools to Support Drug
Development and Review'' to provide information on how a sponsor can
apply to participate in a pilot meetings program with FDA to discuss
MIDD approaches (https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf).
FDA is announcing this pilot meetings program to satisfy the above-
mentioned commitment and to facilitate MIDD approaches. This excludes
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.
The goal of the early meeting discussions granted under this pilot
program is to provide advice on how specific, proposed MIDD approaches
can be used in a specific drug development program. FDA has committed
to accepting two to four meeting requests quarterly each fiscal year.
The meetings granted will include an initial and followup meeting on
the same drug development issues within the span of approximately 120
days.
The listed eligibility factors 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
pilot program evolves. The most current pilot program eligibility
factors and procedures may be found on the MIDD Pilot Program website:
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm600311.htm.
II. Eligibility and Selection for Participation in the MIDD Pilot
Program
The requester 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. Recognizing that FDA will learn both from the
number and types of submissions received for consideration into the
pilot program, FDA welcomes submissions related to any relevant MIDD
topics. However, given that the Agency expects to grant two to four
meeting requests per quarter as part of the pilot program, the Agency
will initially prioritize selecting requests that focus on:
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).
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 pilot 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 Epidemiology, 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 Pilot Program Meeting Request
for CDER'' (CDER applications) or ``MIDD Pilot 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/DevelopmentApprovalProcess/FormsSubmissionRequirements/%20ElectronicSubmissions/ucm153574.htm.
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. 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. 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 or applicants whose meeting requests are granted as part
of the pilot program should submit a meeting information package
electronically with ``MIDD Pilot Program Meeting Package for CDER''
(CDER applications) or ``MIDD Pilot Program Meeting Package for CBER''
(CBER applications) in the subject line no later than 30 days before
each (initial and followup) meeting. This meeting package should
include the following information:
[[Page 16870]]
1. Product name.
2. Application number.
3. Chemical name and structure.
4. Proposed indication(s) 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, and the
status of product development.
6. Proposed agenda, including estimated times needed for discussion
of each agenda item.
7. List of questions for discussion with a brief summary for each
question to explain the need or context for the question.
8. Drug development issue (e.g., dosing, clinical trial design,
safety prediction), including the proposed MIDD approach to the
solution, information to support discussion (e.g., a description of the
data used for developing the models, model development, simulation
plan, results), and how the Agency can help guide any next steps
relative to the regulatory decision making process, which 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 60 days of
each meeting.
IV. Paperwork Reduction Act of 1995
This notice refers to collections of information that are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection
of information resulting from formal meetings between sponsors or
applicants and FDA has been approved under OMB control number 0910-
0429. The collection of information in 21 CFR part 312 (INDs) has been
approved under OMB control number 0910-0014.
Dated: April 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-08010 Filed 4-16-18; 8:45 am]
BILLING CODE 4164-01-P
