Document ID: FDA-2004-N-0191-0005
Agency: fda
Document Type: Proposed Rule
Title: Product Jurisdiction: Correction
Posted Date: 2018-06-07T04:00Z

[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Proposed Rules]
[Page 26392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12201]

[[Page 26392]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 3

[Docket No. FDA-2004-N-0191]

Product Jurisdiction; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; correction.

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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, 
[email protected].

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
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                                                                                                 Units
                                                                                ---------------------------------------
                Category                    Primary        Low          High                                  Period                  Notes
                                            estimate     estimate     estimate       Year       Discount     covered
                                                                                   dollars     rate  (%)     (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:.............................................................................................................................................
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\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