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

Published date10 September 2020
Citation85 FR 55802
Record Number2020-18777
SectionProposed rules
CourtFood And Drug Administration
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.
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:
T
ABLE
1—S
UMMARY OF
B
ENEFITS AND
C
OSTS IN
2018 D
OLLARS
O
VER A
10-Y
EAR
T
IME
H
ORIZON
Category Primary
estimate Low
estimate High
estimate
Units
Notes
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 re-
lated 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 Mon-
etized $/year. ........................ ........................ ........................ ........................ 7
3
From/To .......................... From: To:
Other Annualized Mone-
tized $/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]
BILLING CODE 4164–01–P
DEPARTMENT OF EDUCATION
34 CFR Chapter III
[Docket ID ED–2020–OSERS–0056]
Proposed Priorities and Definitions—
American Indian Vocational
Rehabilitation Services—Training and
Technical Assistance
AGENCY
: Office of Special Education and
Rehabilitative Services (OSERS),
Department of Education.
ACTION
: Proposed priorities and
definitions.
SUMMARY
: 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
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