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Summary: Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications (Proposed Rule)

Summary: Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications (Proposed Rule)

This proposed rule complies with certain mandates of the Sunscreen Innovation Act (Pub. L. 113–195), enacted in November 2014. In particular, the proposed rule would establish timelines and metrics for review of Time and Extent Applications (TEAs) for non-sunscreen OTC drug products. The TEA process offers a pathway for OTC conditions to be marketed under an OTC drug monograph.

Specific timelines applicable to non-sunscreen TEA conditions would be added in a new section to Title 21 of the CFR, § 330.15. The first proposed timeline is to issue a Notice of Eligibility or a post a letter of ineligibility to the TEA docket within 180 days of submission of a TEA. The second proposed timeline is to issue a filing determination within 90 days of receipt of a complete safety and effectiveness data submission from the sponsor once such sponsor has confirmed that it considers the submission to be complete. If we initially determine the active ingredient or other condition not to be generally recognized as safe and effective and not misbranded (GRASE), we will inform sponsors and interested parties within 730 days from the date of filing as defined in proposed § 330.14(a). The next proposed timeline is to issue a notice of proposed rulemaking (NPRM) within 1,095 days from the date of filing. Lastly, we propose to issue a final rule within 912 days of the closing of the docket of the proposed rulemaking.

Regulatory Impact Analysis

Regarding benefits, we expect that the proposed rule would make the TEA process more efficient and predictable, and improve communication between FDA and sponsors. Sponsors may benefit from knowing if additional data is needed and what optimal steps to take to receive a GRASE determination, and we would be able to bring resolution to TEA conditions. However, we do not know the monetary value of added predictability to sponsors.

Regarding costs, we expect the rule would create a minimal burden on sponsors, primarily when they send a letter to request a meeting with us. Thus, we anticipate no increase in annual recurring costs for either small or large sponsors. We expect the six current sponsors of nonsunscreen TEAs covering conditionsthat have been found eligible to be considered for inclusion in the OTC drug monograph system would incur one-time costs to read and understand the proposed rule. We also estimate sponsors will submit two additional TEAs annually, and each of these sponsors would also spend time reading and understanding the proposed rule. The present value of the total costs over 10 years ranges from about $17,000 to $35,000 with a 7 percent discount rate and from about $19,000 to $38,000 with a 3 percent discount rate. With a discount rate of 7 percent and 3 percent, we estimate that on average affected sponsors would incur less than $150 of annualized costs per year.

Federal Register: 81 FR 19069, April 4, 2016

Docket: FDA-2016-N-0543