85 FR 176 pg. 55802 - Annual Summary Reporting Requirements Under the Right To Try Act; Correction

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Type: PRORULEVolume: 85Number: 176Page: 55802

Docket number: [Docket No. FDA–2019–N–5553]

FR document: [FR Doc. 2020–18777 Filed 9–9–20; 8:45 am]

Agency: Health and Human Services Department

Sub Agency: Food and Drug Administration

Official PDF Version: PDF Version

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, 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:

Category	Primary estimate	Low estimate	Units	Year dollars	Discount rate (%)	Period covered
Benefits:
Annualized Monetized $/year			2018 2018	7 3	10 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 $5,785		2018 2018	7 3	10 10
Annualized Quantified				7 3
Qualitative
Transfers:
Federal Annualized Monetized $/year				7 3
From/To	From:	To:
Other Annualized Monetized $/year				7 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]

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