[Federal Register Volume 85, Number 157 (Thursday, August 13, 2020)]
[Notices]
[Pages 49377-49379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17721]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1550]
New Drugs Regulatory Program Modernization: Implementation of the
Integrated Assessment of Marketing Applications and Integrated Review
Documentation; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the following public workshop entitled ``New Drugs
Regulatory Program Modernization: Implementation of the Integrated
Assessment of Marketing Applications and Integrated Review
Documentation.'' The purpose of the public workshop is to seek public
comments/feedback on the Integrated Review documentation generated by
the new Integrated Assessment of marketing applications for new drug
products developed as part of the New Drugs Regulatory Program
Modernization. The Agency hopes to receive public feedback on how this
Integrated Review documentation can continue supporting our
stakeholders' needs. Please see information and examples relevant to
the Integrated Review at http://wcms-internet.fda.gov/drugs/news-events-human-drugs/integrated-assessment-marketing-applications-workshop-10302020-10302020.
DATES: The public workshop will be held virtually and broadcast via
webcast only on October 30, 2020, from 9 a.m. to 3 p.m. Registration to
attend the meeting and other information can be found at http://wcms-internet.fda.gov/drugs/news-events-human-drugs/integrated-assessment-marketing-applications-workshop-10302020-10302020. The public meeting
may be extended or may end early depending on the level of public
participation. Submit either electronic or written comments on this
public workshop by December 30, 2020. See the SUPPLEMENTARY INFORMATION
section for registration date and information.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 30, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 30, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is 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-2020-N-1550 for ``New Drugs Regulatory Program Modernization:
Implementation of the Integrated Assessment of Marketing Applications
and Integrated Review Documentation.'' 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.
[[Page 49378]]
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: Rhonda M. Hearns-Stewart, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3249, Silver Spring, MD 20993-0002, 240-
402-3180, [email protected], with the subject line
``Collecting Public Feedback on the Integrated Assessment.''
SUPPLEMENTARY INFORMATION:
I. Background
The Integrated Assessment of marketing applications includes a new
process and review template for the assessment and documentation of new
drug product marketing applications (e.g., new drug applications or
biologics license applications (BLAs)) in the Center for Drug
Evaluation and Research. The resultant Integrated Review is the product
of an interdisciplinary team assessment process that provides
collaborative discussions of key review issues that span multiple
disciplines and includes resolution of important issues pertinent to
benefit-risk assessments. This interdisciplinary approach facilitates
clarity of decision making and ensures input from relevant disciplines
in the consideration of scientific issues. FDA believes the format and
content of the Integrated Review documentation will provide sufficient
detail concerning the evidence of efficacy and assessment of risk and
risk management as well as a clearer description of FDA's analysis of
the scientific issues raised by the application and the scientific
reasoning supporting the benefit-risk determination. The overall
objective is to more effectively communicate the basis for FDA's
decision on applications.
This new Integrated Review document replaces the current
documentation, which included a separate review document authored by
each discipline. It also replaces the multidisciplinary review (i.e.,
Unireview) in which each discipline provided a separate review section
but within a single review document. FDA is currently undergoing a
phased implementation of the Integrated Review documentation for new
molecular entities, original BLAs, and select efficacy supplements. FDA
plans to expand the scope to other marketing application types in the
near future.
The following guiding principles informed the Integrated Assessment
process and associated Integrated Review documentation:
The importance of conducting an issue-focused assessment,
enhanced communication both within the review team and
with the applicant, and
strong interdisciplinary collaboration.
The Integrated Review documentation template has three main
components:
Executive Summary:
[cir] Represents FDA's conclusions regarding key scientific and
regulatory issues while describing any differences of scientific
opinion or perspective,
[cir] provides a summary of FDA's decision and assessment of the
application, including FDA's benefit-risk determination (as currently
employed in marketing application reviews), and
[cir] provides an overall Agency assessment, including an overview
of the major decisions made during the review process, and a brief
discussion of the basis for the decisions.
Interdisciplinary Assessment:
[cir] Includes succinct, integrated, focused analyses of the
evidence of benefit, risk and risk management, and therapeutic
individualization (e.g., special populations, drug interactions).
[cir] Highlights key review issues (including analyses specific to
key issues) the review team thinks are pertinent to the decision-making
process. Issues are presented and assessed in an interdisciplinary
manner.
[cir] Includes any dissenting data interpretations.
Discipline-Specific Appendices:
[cir] Contains assessments and analyses that are supportive and/or
important to key facts/data or conclusions included in the overall
review, and in certain instances may include discipline-specific
content (e.g., relevant pharmacology/toxicology information),
[cir] May contain work that did not directly impact the overall
assessment of benefit-risk, regulatory action, labeling, or risk-
mitigation plans, and
[cir] includes separate reviews of reviewers who disagree with
significant elements of the Executive Summary and Interdisciplinary
Assessment sections or the decision of the Signatory Authority.
In general, the first two parts of the Integrated Review document
would be expected to provide a complete explanation of FDA's action and
supporting analyses, with the third component (the appendices)
providing additional detail on the comprehensive analyses FDA conducted
in its review of the drug application.
The target audiences for this document are diverse and include
those with a specific interest in the application such as the lay
public, drug sponsors, researchers, and others who are seeking to
understand the basis for FDA's decision.
As part of FDA's ongoing evaluation of the Integrated Assessment
and its implementation, the Agency is interested in receiving responses
to the following questions/topics, in addition to any general comments
the public might have. For convenience, it would be helpful if
commenters refer to the numbered question and topic when submitting
responses and comments.
II. Topics for Discussion at the Public Workshop
The Agency is soliciting public feedback on how the Integrated
Review can continue supporting our stakeholders' needs.
The Agency welcomes any relevant information specific to the
Integrated Review that stakeholders wish to share
[[Page 49379]]
at the meeting or in a submission to the docket, but we emphasize that
the focus of this meeting is to seek input that prioritizes feedback
specifically on characteristics of the Integrated Review document.
Please see information and examples relevant to the Integrated Review
at http://wcms-internet.fda.gov/drugs/news-events-human-drugs/integrated-assessment-marketing-applications-workshop-10302020-10302020.
Furthermore, we anticipate that the most informative suggestions
would not be specific to an indication, a therapeutic area, or a
disease but rather apply across multiple indications, therapeutic
areas, or diseases. We are particularly interested in the topics that
follow:
1. We are interested in preserving for stakeholders what they find
most useful in FDA reviews.
a. Comparing the Integrated Review to previous reviews, is there
any information you are having difficulty locating?
b. Are you able to use the Integrated Review for the same purpose
that you used previous reviews? If not, please provide specific
examples.
2. We are interested in specific recommendations about any areas of
the Integrated Review documentation of the Integrated Assessment that
can be improved to meet the needs of stakeholders.
3. We are interested in stakeholders' views regarding the
advantages and disadvantages of an interdisciplinary assessment
presentation of key review issues and resulting integration of the
assessments of multiple disciplines into a single Integrated Review
document.
4. We would like to know whether the new format of the Integrated
Review document for the Integrated Assessment can provide clarity of
benefit-risk assessments and inform your knowledge of FDA's basis for
making decisions.
III. Participating in the Public Workshop
Registration: Please visit the following website to register:
https://www.eventbrite.com/e/integrated-assessment-of-marketing-applications-workshop-tickets-102979608782. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone.
Persons interested in attending this virtual public workshop must
register by September 30, 2020, by 11:59 p.m. Eastern Time.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session or
participate in a specific session, and which topic(s) you wish to
address. We will do our best to accommodate requests to make public
comments and requests to participate in the focused sessions.
Individuals and organizations with common interests are urged to
consolidate or coordinate their presentations, and request time for a
joint presentation, or submit requests for designated representatives
to participate in the focused sessions. Following the close of
registration, we will determine the amount of time allotted to each
presenter and the approximate time each oral presentation is to begin,
and will select and notify participants by October 14, 2020. All
requests to make oral presentations must be received by the close of
registration on September 30, 2020, by 11:59 p.m. EST. If selected for
presentation, submit electronic copies of any presentation materials
(Power Point or PDF) to [email protected] no later than
October 21, 2020. No commercial or promotional material will be
permitted to be presented or distributed at the public workshop.
Streaming Webcast of the Public Workshop: This webcast for this
public workshop is available at https://collaboration.fda.gov/newdrugs103020/. If you have never attended a Connect Pro event before,
test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro
program, visit https://www.adobe.com/go/connectpro_overview. FDA has
verified the website addresses in this document, as of the date this
document publishes in the Federal Register, but websites are subject to
change over time.
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at http://wcms-internet.fda.gov/drugs/news-events-human-drugs/integrated-assessment-marketing-applications-workshop-10302020-10302020.
Dated: August 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17721 Filed 8-12-20; 8:45 am]
BILLING CODE 4164-01-P