Proposed Rules. Proposed rule; correction

Agency: Food and Drug Administration, HHS
Action: Proposed rule; correction
Citation: FR Doc. 2018-12201 · Docket No. FDA-2004-N-0191 · 21 CFR 3

Summary

The Food and Drug Administration is correcting a proposed rule to amend its regulations concerning the classification of products as biological products, devices, drugs, or combination products, and their assignment to Agency components for premarket review and regulation that appeared in the Federal Register of May 15, 2018. The document was published with an error in the discussion of the preliminary economic analysis impact. This document corrects that error.

Dates

Submit either electronic or written comments on the proposed rule by July 16, 2018.

Supplementary Information

In the Federal Register of Tuesday, May 15, 2018, beginning on page 22428 for FR Doc. 2018-10321, table 1 on page 22433 is corrected to read: Table 1—Benefits, Costs, and Distributional Effects of the Proposed Rule 1 2 Category Primary estimate Low estimate High estimate Units Year dollars Discount rate (%) Period covered (years) Notes Costs: Annualized $17,000 $12,000 $27,000 2016 7 10 Monetized $/year 15,000 10,000 23,000 2016 3 10 Annualized 7 Quantified 3 Qualitative Benefits: Annualized 28,000 25,000 89,000 2016 7 10 Monetized $/year 28,000 25,000 89,000 2016 3 10 Annualized 7 Quantified 3 Qualitative Firms and FDA may realize savings from sponsors choosing to submit electronic RFDs Transfers: Federal 7 Annualized Monetized $millions/year 3 From/To From: To: Other 7 Annualized Monetized $millions/year 3 From/To From: To: Effects: State, Local or Tribal Government: Small Business: Will not have a significant impact on a substantial number of small entities. Wages: Growth: 1 We use a 10-year time horizon for this rule with payments occurring at the end of each period. 2 All dollar values are rounded to the nearest $1,000. Dated: June 1, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-12201 Filed 6-6-18; 8:45 am]