# 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:
| Category | Primary | Low | High | Units | Year | Discount rate | Period | Notes |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Benefits: | | | | | | | | |
| Annualized Monetized $/year | | | | 2018 | 7 | 10 | | |
| Annualized Quantified | | | | | 7 | | | |
| Qualitative | | | | | | | Disclosure of serious adverse events and outcomes related to investigational new drug treatments. | |
| Costs: | | | | | | | | |
| Annualized Monetized $/year | $5,694 | | | 2018 | 7 | 10 | | |
| Annualized Quantified | | | | | 7 | | | |
| Qualitative | | | | | | | | |
| Transfers: | | | | | | | | |
| Federal Annualized Monetized $/year | | | | | 7 | | | |
| From/To | From: | To: | | | | | | |
| Other Annualized Monetized $/year | | | | | 7 | | | |
| 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.