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Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Notices FDA will continue regular meetings between FDA and industry IT
leadership to discuss challenges, emerging needs, and progress on IT
initiatives relevant to PDUFA VII.
Additionally, FDA will advance the use of cloud-based technology in the PDUFA program to modernize the Electronic Submission Gateway and promote innovation in drug development and the regulatory review process. These enhancements are described in section IV.A of the proposed PDUFA VII commitment letter.

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L. Expanding and Enhancing Bioinformatics Support Bioinformatics and computational biology are increasingly being used to assess product quality, safety, and efficacy, and facilitate the development, characterization, and manufacture of human drugs and biologics. Recognizing the substantial increase in the volume and diversity of bioinformatics and computational biology information and data in regulatory submissions, such as Next Generation Sequencing, FDA
proposes numerous activities to meet this growing need. These activities will include developing additional expertise and staff capacity in both CDER and CBER to efficiently review and provide technical and timely feedback, assessing and strengthening the computational infrastructure to support and advance our informatics platforms, and continuing to develop data standards and to issue/revise guidances on these topics. These enhancements are described in section IV.B of the proposed PDUFA VII commitment letter.
M. Enhancing Use of Digital Health Technologies DHTs To Support Drug Development and Review While the biomedical field has experienced rapid development and implementation of DHTs, FDA has limited experience evaluating novel DHT-based measurements in human drug development. FDA recognizes the potential for DHTs to provide scientific and practical advantages in supporting the assessment of patients by generating information outside of the traditional clinic visit. FDA also recognizes the need to build capacity and expertise to advise the biopharmaceutical industry in their development and implementation and to evaluate DHT
outputs including the impact of regulatory initiatives or regulatory science. To support new drug registration, label expansion, and safety monitoring, DHT-based data need to be fit for the intended purpose. Toward
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these ends, FDA proposes to undertake numerous activities, including the publication of a framework document to guide the use of DHT-derived data in regulatory decision making, the formation of a committee to provide support to DHT-related efforts, and a series of public meetings, demonstration projects, and new or updated guidances.
These enhancements are described in section IV.C of the proposed PDUFA VII
commitment letter.

panels with FDA and Industry representatives to present and discuss the agreed-upon proposed enhancements. For members of the public who would like to make verbal comments on the proposed enhancements see instructions below, there will be a public comment period at the end of the meeting. We will also provide an opportunity for individuals to submit written comments to the docket before and after the meeting.

N. Enhancements to Fee Mechanisms for Increased Predictability, Stability, and Efficiency The PDUFA VII agreement continues to build on the resource capacity planning capability established in PDUFA VI and continues financial transparency initiatives. In addition, PDUFA VII enhances mechanism to manage financial risks by establishing a minimum amount of available operating reserves to be maintained each year.
This minimum amount will start at an amount equivalent to 8 weeks of operations and increase to 10 weeks of operations by FY 2025. PDUFA VII also adds a strategic hiring and retention adjustment to ensure FDA has the funding necessary to provide for the costs of retaining and hiring highly qualified scientific and technical staff for the process for the review of human drug applications under PDUFA. This strategic hiring and retention adjustment will add $9 million to the base revenue amount in FY 2023 and $4
million in each subsequent year.

B. Participating in the Public Meeting Registration: Registration is optional and not required to attend this virtual public meeting. However, registering will allow FDA to provide you with email updates if any meeting details change. If you wish to register, you can do so at https pdufaviireauthorization.eventbrite.com.
Opportunity for Verbal Public Comment: Those who register online will receive a confirmation email that includes a link to a request form to make a verbal public comment at the meeting. If you wish to speak during the public comment session, follow the instructions in that email and identify which topics you wish to address. We will do our best to accommodate requests to make public comments.
Individuals and organizations with common interests are urged to consolidate or coordinate their comments and request time jointly. All requests to make a public comment during the meeting must be received by September 14, 2021, 11:59 p.m. Eastern Time. Depending on the number of requests, we will determine the amount of time allotted to each commenter, the approximate time each comment is to begin, and will select and notify participants by September 21, 2021. No commercial or promotional material will be permitted to be presented at the public meeting.
Streaming Webcast of the Public Meeting: The Zoom Webinar ID for this public meeting is 161 932 6064. The webcast link for this public meeting can be found here: https
fda.zoomgov.com/j/1619326064?pwd=
WWZhZXhYRDNoYmg0W
FRvSVgvdE5BUT09.
The link above should allow you to enter the webinar directly. If Zoom asks for a passcode, please use the casesensitive passcode below.
Case-Sensitive Passcode for Zoom Webinar: PDUFa7!
Transcripts: Please be advised that as soon as a transcript of the public meeting 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
O. Impact of PDUFA VII Enhancements on User Fee Revenue To implement the proposed enhancements for PDUFA VII, funding for a cumulative total of 352 full-time equivalent staff is proposed to be phased in over the course of PDUFA VII.
The new funding will be phased in as follows:
$65,773,693 for FY 2023
$25,097,671 for FY 2024
$14,154,169 for FY 2025
$4,864,860 for FY 2026
$1,314,620 for FY 2027
In addition, to support the other additional direct costs associated with PDUFA VII enhancements, the following amounts will be added:
$44,386,150 for FY 2023
$60,967,993 for FY 2024
$35,799,314 for FY 2025
$35,799,314 for FY 2026
$35,799,314 for FY 2027
IV. Public Meeting Information A. Purpose and Scope of the Meeting The meeting will include a presentation by FDA and a series of
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