2018-12201. Product Jurisdiction; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Proposed rule; correction.

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.

FOR FURTHER INFORMATION CONTACT:

Melissa Burns, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20933, 301-796-8930, [e-mail].

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			Notes
				Year dollars	Discount rate (%)	Period covered (years)
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.