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This rule would amend FDA's regulations to promote electronic submissions and reduce paper submission, including by removing requirements for submission of multiple copies and replace them with the requirement for a single submission in electronic format. This action is being undertaken to revise regulations that required paper submission.

Statement of Need:

The proposed rule, if finalized, would remove express or implied requirements for submission of multiple copies as well as the requirement or option to provide paper submissions for a large number of programs and processes administered by the Agency and replace them with a requirement for single submissions in electronic format. Because electronic submission is easily reproducible, the requirement for multiple copies is no longer necessary. FDA believes it is beneficial to the public to limit any burden and expense to submitters caused by requiring additional copies, and that due to the essentially universal availability of electronic devices that can transmit documents in electronic format, the Agency no longer needs to provide the option to submit information on paper. In conjunction with related efforts focused on existing records, this rule would facilitate a fully digital system of records submitted to and maintained by the Agency. FDA considers that such a system would enhance the efficiency of the Agency’s operations and also facilitate transparency in records requests. To help ensure access to FDA’s submission processes for all participants, the Agency intends to provide the ability to request a waiver for individual paper submissions.

Summary of the Legal Basis:

FDA is issuing this rule from the same authority under which FDA initially issued the applicable regulations. In addition, section 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(a)) grants FDA general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act.

Alternatives:

Alternative 1 : Remove express or implied requirements for paper submissions but continue to accept them if submitted.

Given the availability of a waiver process, the primary beneficiaries of this option would be entities with the ability or option to submit electronically but who do not choose to do so. Compared to the proposed approach, this option would be less effective at reducing administrative complexity and system fragmentation going forward and would reduce the accessibility of Agency records.

Alternative 2 : Require electronic submissions only for a subset of submission processes.

This option would involve selecting certain submission processes for mandatory electronic submission. As with Alternative 1, we anticipate this option would be less effective at reducing administrative complexity and system fragmentation going forward and would reduce the accessibility of Agency records. In addition, this approach could potentially result in concerns of unbalanced treatment of different stakeholders or industry sectors based on the selected processes.

Anticipated Costs and Benefits:

The rule would amend regulations to reduce or eliminate submitting multiple copies to the Agency for a large number of programs and processes.  The rule would also amend regulations containing a reference to the specific form of a submission to require that the submission be in electronic format.  The rule would produce cost-savings for firms and FDA without imposing any additional regulatory burdens or affecting the Agency’s ability to review submissions.  Firms would incur minimal administrative costs to read and understand the rule.  Some firms and individuals that currently send their submissions by mail may incur the costs of submit electronically.

Risks:

TBD