[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