[Federal Register Volume 89, Number 178 (Friday, September 13, 2024)]
[Notices]
[Pages 74966-74968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20891]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-3878]


New Drugs Regulatory Program Modernization: Integrated Assessment 
of Marketing Applications and Integrated Review Documentation; Request 
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
seeking public comments on the ``New Drugs Regulatory Program 
Modernization: Integrated Assessment of Marketing Applications and 
Integrated Review Documentation.'' The purpose is to seek public 
comments/feedback on the Integrated Review documentation generated by 
the 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.

DATES: Submit either electronic or written comments on the notice by 
December 12, 2024.

[[Page 74967]]


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 December 12, 2024. 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-2024-N-3878 for ``New Drugs Regulatory Program Modernization: 
Integrated Assessment of Marketing Applications and Integrated Review 
Documentation; Request for Comments.'' 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.'' 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. 6460, Silver Spring, MD 20993-0002, 240-
402-3180, [email protected], with the subject line 
``Collecting Public Feedback on the Integrated Review.''

SUPPLEMENTARY INFORMATION:

I. Background

    The Integrated Assessment of Marketing Applications, which is part 
of FDA's New Drugs Regulatory Program Modernization, includes a new 
review template for the assessment and documentation of new drug 
product marketing applications (e.g., new drug applications (NDAs) 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 previous 
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 implemented 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 Review 
documentation:
     The importance of conducting an issue-focused assessment,
     Enhanced communication within the review team, 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,

[[Page 74968]]

    [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.
 Additional Analyses and Information:
    [cir] Includes 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 
are expected to provide a complete explanation of FDA's action and 
supporting analyses, with the third component (the additional analyses 
and information) 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.

II. Integrated Review Documentation

    As part of FDA's ongoing evaluation of the Integrated Review 
documentation, the Agency welcomes comments and any relevant 
information specific to the Integrated Review that stakeholders wish to 
share in a submission to the docket. However, we emphasize that the 
focus 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 https://www.fda.gov/drugs/news-events-human-drugs/new-drugs-regulatory-program-modernization-integrated-assessment-marketing-applications-and.
    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. 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.
    1. We are interested in preserving for stakeholders what they find 
most useful in FDA reviews.
    a. Comparing the Integrated Review to previous review 
documentation, 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 the resultant 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 documentation for the Integrated Assessment provides clarity of 
benefit-risk assessments and informs your knowledge of FDA's basis for 
making decisions.
    5. Based on the integrated review, were the issues that concerned 
the review team clear and understandable? If so, what helped achieve 
this? If not, what can be improved?

    Dated: September 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20891 Filed 9-12-24; 8:45 am]
BILLING CODE 4164-01-P