Proposed Rules. Proposed rule; correction

425 words·~2 min read·/register/2020/09/10/2020-18777

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BILLING CODE 3510-DS-P 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: Table 1—Summary of Benefits and Costs in 2018 Dollars Over a 10-Year Time Horizon Category Primary estimate Low estimate High estimate Units Year dollars Discount rate (%) Period covered Notes 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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