Annual Summary Reporting Requirements Under the Right To Try Act; Correction, 55802 [2020-18777]

Download as PDF 55802 Federal Register / Vol. 85, No. 176 / Thursday, September 10, 2020 / Proposed Rules 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. The Food and Drug Administration (FDA, the Agency, or we) is correcting a proposed rule that published in the Federal Register of SUMMARY: 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, kathleen.davies@fda.hhs.gov. 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 Category Primary estimate Low estimate High estimate Year dollars Discount rate (%) 7 3 7 3 ........................ Benefits: Annualized Monetized $/ year. Annualized Quantified .... ........................ ........................ ........................ ........................ ........................ ........................ 2018 2018 ........................ Qualitative ...................... ........................ ........................ ........................ ........................ Costs: Annualized Monetized $/ year. Annualized Quantified .... $5,694 $5,785 ........................ ........................ ........................ ........................ ........................ 2018 2018 ........................ 7 3 7 3 ........................ ........................ ........................ ........................ 7 3 ........................ ........................ Qualitative Transfers: Federal Annualized Monetized $/year. From/To .......................... From: Other Annualized Monetized $/year. ........................ From/To .......................... From: Effects: ................................... ........................ ........................ Disclosure of serious adverse events and outcomes related to investigational new drug treatments. 10 10 7 3 To: State, Local or Tribal Government: Small Business: Wages: Growth: DEPARTMENT OF EDUCATION Proposed Priorities and Definitions— American Indian Vocational Rehabilitation Services—Training and Technical Assistance Office of Special Education and Rehabilitative Services (OSERS), Department of Education. AGENCY: 19:31 Sep 09, 2020 Jkt 250001 The Department of Education (Department) proposes priorities and definitions to fund an American Indian Vocational Rehabilitation Training and Technical Assistance Center (AIVRTTAC), Catalog of Federal Domestic Assistance (CFDA) number 84.250Z. The Department may use the priorities and definitions for competitions in fiscal year (FY) 2020 and later years. We take this action to focus Federal financial assistance on SUMMARY: [Docket ID ED–2020–OSERS–0056] BILLING CODE 4164–01–P Proposed priorities and definitions. ACTION: 34 CFR Chapter III [FR Doc. 2020–18777 Filed 9–9–20; 8:45 am] khammond on DSKJM1Z7X2PROD with PROPOSALS 10 10 To: Dated: August 20, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. VerDate Sep<11>2014 Notes Period covered PO 00000 Frm 00017 Fmt 4702 Sfmt 4702 E:\FR\FM\10SEP1.SGM 10SEP1

Agencies

[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.

-----------------------------------------------------------------------

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:
--------------------------------------------------------------------------------------------------------------------------------------------------------


    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

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