[Federal Register Volume 85, Number 176 (Thursday, September 10, 2020)]
[Proposed Rules]
[Page 55802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18777]



[[Page 55802]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 300

[Docket No. FDA-2019-N-5553]
RIN 0910-AI36


Annual Summary Reporting Requirements Under the Right To Try Act; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; correction.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
correcting a proposed rule that published in the Federal Register of 
July 24, 2020. That proposed rule proposes to establish requirements 
for the deadline and contents of submission in an annual summary. We 
are placing a corrected copy of the proposed rule in the docket.

FOR FURTHER INFORMATION CONTACT: Kathleen Davies, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3121, Silver 
Spring, MD 20993, 301-796-2205, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of July 24, 2020, 
(85 FR 44803), FDA published the proposed rule ``Annual Summary 
Reporting Requirements Under the Right to Try Act'' with several 
errors.
    In the Federal Register of July 24, 2020, FR Doc. 2020-16016, the 
following corrections are made:
    On page 44804, in the third column, in section ``D. Costs and 
Benefits'' the first paragraph, the fourth and fifth sentences are 
corrected as follows: ``The total estimated present value of this 
rule's costs is $39,991 at a seven percent discount rate and $49,345 at 
a three percent discount rate (in 2018 dollars). The annualized cost of 
this rule over 10 years is $5,694 at a seven percent discount rate and 
$5,785 at a three percent discount rate.'' On page 44808, in table 1, 
in column 2 (``Primary estimate'') rows 4 and 5 (``Costs'' category) 
are corrected as follows: ``$5,694'' and $5,785'', respectively, and 
the ``7'' in column 4 (``High estimate'') is removed. On pages 44808 
and 44809, in column 6 (``Discount Rate (10%)'') is corrected to read 
as follows:

                                   Table 1--Summary of Benefits and Costs in 2018 Dollars Over a 10-Year Time Horizon
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                         Units
                                        Primary                                    ------------------------------------------------
             Category                  estimate      Low estimate    High estimate                   Discount rate                          Notes
                                                                                     Year dollars         (%)       Period covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $/year...  ..............  ..............  ..............            2018               7              10
                                                                                              2018               3              10
    Annualized Quantified.........  ..............  ..............  ..............  ..............               7
                                                                                                                 3
    Qualitative...................  ..............  ..............  ..............  ..............  ..............  ..............  Disclosure of
                                                                                                                                     serious adverse
                                                                                                                                     events and outcomes
                                                                                                                                     related to
                                                                                                                                     investigational new
                                                                                                                                     drug treatments.
Costs:
    Annualized Monetized $/year...          $5,694  ..............  ..............            2018               7              10
                                            $5,785                                            2018               3              10
    Annualized Quantified.........  ..............  ..............  ..............  ..............               7
                                                                                                                 3
    Qualitative
Transfers:
    Federal Annualized Monetized $/ ..............  ..............  ..............  ..............               7
     year.                                                                                                       3
                                   ---------------------------------------------------------------------------------------------------------------------
    From/To.......................  From:
                                    To:
                                   ---------------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized $/   ..............  ..............  ..............  ..............               7
     year.                                                                                                       3
                                   ---------------------------------------------------------------------------------------------------------------------
    From/To.......................  From:
                                    To:
                                   ---------------------------------------------------------------------------------------------------------------------
Effects:..........................  State, Local or Tribal Government:
                                    Small Business:
                                    Wages:
                                    Growth:
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    Dated: August 20, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-18777 Filed 9-9-20; 8:45 am]
BILLING CODE 4164-01-P