Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Health and Human Services Food and Drug Administration 21 CFR Part 3
[Docket No. FDA-2004-N-0191]
 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, 
                        *melissa.burns@fda.hhs.gov.*


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
NotesYear 
                             dollars
Discount rate 
                             (%)
Period 
                             covered  
                             (years)Costs:Annualized
$17,000
$12,000
$27,000
2016
7
10Monetized $/year
15,000
10,000
23,000
2016
3
10Annualized




7Quantified




3QualitativeBenefits:Annualized
28,000
25,000
89,000
2016
7
10Monetized $/year
28,000
25,000
89,000
2016
3
10Annualized




7Quantified




3Qualitative
Firms and FDA may realize savings from sponsors choosing to submit electronic RFDsTransfers:Federal




7AnnualizedMonetized $millions/year




3From/To
From:
To:Other




7AnnualizedMonetized $millions/year




3From/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] BILLING CODE 4164-01-P