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Federal Register / Vol. 86, No. 181 / Wednesday, September 22, 2021 / Notices
only communication. These enhancements are described in section I.H of the proposed BsUFA III
Commitment Letter.
C. Promoting Best Practices in Communication Between FDA and Sponsors During Application Review To enhance communication with sponsors during biosimilar biologic product application review, FDA
proposes to update relevant guidances, our Manual of Policies and Procedures, and our Standard Operating Procedures and Policies regarding best practices in communication. FDA would utilize lessons learned from BsUFA II to update the relevant documents, as appropriate.
The details of this enhancement are found in section II.A of the proposed BsUFA III Commitment Letter.
D. Enhancing Inspection Communication and Alternative Tools To facilitate the timely development of biosimilar biological products and their availability to patients, FDA
proposes to notify sponsors of certain pre-license inspections and to issue guidance on FDAs thinking on the use of alternative tools to assess manufacturing facilities beyond the COVID19 pandemic. These enhancements are described in section II.B of the proposed BsUFA III
Commitment Letter.
E. Advancing Development of Biosimilar Biological-Device Combination Products Regulated by CDER and CBER
Sponsors employ Use-Related Risk Analyses URRA studies to identify the need for risk mitigation strategies and to design a human factors HF validation study. Based on a URRA, a sponsor may propose that a HF validation study is not needed to support the safe and effective use of a biosimilar biologicdevice combination product. FDA
proposes establishing new procedures for the review of URRAs along with performance goals. Human factors studies are conducted to evaluate the user interface of a biosimilar biologicdevice combination product to eliminate or mitigate use-related hazards that may affect the safe and effective use of the combination product. Over the past decade, more combination products have been developed to deliver therapeutics via different routes of administration e.g., parenteral, inhalation with complex engineering designs. HF validation protocols are reviewed during the investigational new drug application stage with the goal towards developing a final finished combination product that supports the marketing application.

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To achieve this objective, FDA proposes updating the procedures for HF
validation study protocols, along with a new performance goal. These enhancements are described in section II.C of the proposed BsUFA III
Commitment Letter.
F. Advancing Development of Interchangeable Biosimilar Biological Products FDA proposes a focused effort in BsUFA III to further advance the development of safe and effective interchangeable biosimilar biological products. This effort would address current needs, prospectively identify future needs, and incorporate the following components: 1 Research leveraging the BsUFA III Regulatory Science Pilot Program; 2 foundational guidance development; and 3
stakeholder engagement involving a scientific workshop on the development of interchangeable biosimilar biological products to help identify future needs.
Associated with this workshop, FDA
would issue draft and final strategy documents outlining FDAs actions to facilitate the development of interchangeable biosimilar biological products. The details of this enhancement are described in section II.D of the proposed BsUFA III
Commitment Letter.
G. Regulatory Science To enhance regulatory decisionmaking and facilitate science-based recommendations in areas foundational to biosimilar biological product development, FDA proposes to pilot a regulatory science program broadly applicable to biosimilar and interchangeable biological product development, with project goals not specific to a product or product class.
The pilot program would focus on two demonstration projects: 1 Advancing the development of interchangeable biosimilar biological products and 2
improving the efficiency of biosimilar biological product development. As part of these demonstration projects, FDA
proposes to engage stakeholders in a public meeting to review the progress of the demonstration projects and to solicit input of future priorities. An interim report would be issued prior to the public meeting, and a final summary report of outcomes from the pilot program would be posted on FDAs website. Within 12 months of completing the demonstration projects, FDA would publish a comprehensive strategy document outlining actions FDA will take to facilitate the development of biosimilar and interchangeable biological products.

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These enhancements are described in section II.E of the proposed BsUFA III
Commitment Letter.
H. Continued Enhancement of User Fee Resource Management FDA is committed to ensuring the sustainability of BsUFA program resources and to enhancing the operational agility of the BsUFA
program. FDA proposes to build on the financial enhancements included in BsUFA II and continue activities in BsUFA III to ensure optimal use of user fee resources and the alignment of staff to workload through the continued maturation and assessment of the Agencys resource capacity planning capability. This proposal would also include an independent assessment of the resource capacity planning capability. FDA proposes to continue activities to promote transparency of the use of financial resources in support of the BsUFA program through annual public meetings, publishing a 5-year financial plan along with annual updates, and additional reporting in the annual BsUFA Financial Report. These enhancements are described in section III of the proposed BsUFA III
Commitment Letter.
I. Information Technology FDA proposes to establish and progress a data and technology modernization strategy that provides FDAs strategic direction for current and future state data-driven regulatory initiatives. Additionally, FDA would advance the use of cloud-based technology to modernize the Electronic Submission Gateway to support greater data submission bandwidth and storage in the BsUFA program. These enhancements are described in section V of the proposed BsUFA III
Commitment Letter.
J. Enhancements to Fee Mechanisms for Increased Predictability, Stability, and Efficiency The proposed BsUFA III agreement continues to build on the resource capacity planning capability established in BsUFA II and continues financial transparency initiatives. In addition, to manage financial risks in the program, BsUFA III proposes to enhance the operating reserve adjustment mechanism to provide for a defined minimum and maximum required amount of operating reserves. The proposed minimum amount is equivalent to 10 weeks of operating reserves and the maximum amount is equivalent to 21 weeks of available operating reserves to be maintained each year. The annual maximum
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