0910-AI50 202510 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Modernizing Regulations to Promote Electronic Submission and Reduce Paper Submission

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.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No Deregulatory 21 CFR 101.69 21 CFR 130.17 21 CFR 171.1 21 CFR 571.1 21 CFR 71.1 21 CFR 10.20 21 CFR 10.40 21 CFR 10.85 21 CFR 314.94 21 CFR 314.50 5 U.S.C. 551 to 558 5 U.S.C. 701 to 706 15 U.S.C. 1453 15 U.S.C. 1454 15 U.S.C. 1455 21 U.S.C. 141 to 149 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 336 21 U.S.C. 341 21 U.S.C. 342 21 U.S.C. 343 21 U.S.C. 348 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 353 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 360c 21 U.S.C. 360j 21 U.S.C. 360l 21 U.S.C. 360aa 21 U.S.C. 360aaa-6 21 U.S.C. 360b-360f 21 U.S.C. 360bbb-8b 21 U.S.C. 360h to 360i 21 U.S.C. 361 21 U.S.C. 371 21 U.S.C. 372 21 U.S.C. 373 21 U.S.C. 374 21 U.S.C. 375 21 U.S.C. 379 21 U.S.C. 379e 21 U.S.C. 379k-1 21 U.S.C. 381 21 U.S.C. 467f 21 U.S.C. 679 21 U.S.C. 821 21 U.S.C. 1034 28 U.S.C. 2112 42 U.S.C. 201 42 U.S.C. 216 42 U.S.C. 241 42 U.S.C. 243 42 U.S.C. 262 42 U.S.C. 263b 42 U.S.C. 264 42 U.S.C. 271 ... Statutory NPRM 09/30/2022 Yes

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.

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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.

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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.

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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.

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TBD

]]> NPRM 12/00/2026 No Businesses None No No No Shena Arellano Policy Analyst 0910 Food and Drug Administration FDA 301 796-8353 shena.arellano@fda.hhs.gov Office of the Commissioner, 10903 New Hampshire Avenue, Silver Spring MD 20993