Product Jurisdiction; Correction, 26392 [2018-12201]
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26392
Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Proposed Rules
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 3
[Docket No. FDA–2004–N–0191]
Product Jurisdiction; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule; correction.
rule to amend its regulations concerning
the classification of products as
biological products, devices, drugs, or
combination products, and their
assignment to Agency components for
premarket review and regulation that
appeared in the Federal Register of May
15, 2018. The document was published
with an error in the discussion of the
preliminary economic analysis impact.
This document corrects that error.
Submit either electronic or
written comments on the proposed rule
by July 16, 2018.
DATES:
The Food and Drug
Administration is correcting a proposed
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Melissa Burns, Office of Combination
Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5129, Silver Spring,
MD 20933, 301–796–8930,
melissa.burns@fda.hhs.gov.
In the
Federal Register of Tuesday, May 15,
2018, beginning on page 22428 for FR
Doc. 2018–10321, table 1 on page 22433
is corrected to read:
SUPPLEMENTARY INFORMATION:
TABLE 1—BENEFITS, COSTS, AND DISTRIBUTIONAL EFFECTS OF THE PROPOSED RULE 1 2
Units
Primary
estimate
Low
estimate
High
estimate
$17,000
15,000
....................
....................
....................
$12,000
10,000
....................
....................
....................
28,000
28,000
....................
....................
25,000
25,000
....................
....................
Category
Costs:
Annualized .................................
Monetized $/year .......................
Annualized .................................
Quantified ...................................
Qualitative ..................................
Benefits:
Annualized .................................
Monetized $/year .......................
Annualized .................................
Quantified ...................................
Qualitative ..................................
Transfers:
Federal .......................................
Annualized
Monetized $millions/year ...........
Year
dollars
Discount
rate
(%)
Period
covered
(years)
$27,000
23,000
....................
....................
....................
2016
2016
....................
....................
....................
7
3
7
3
....................
10
10
....................
....................
....................
89,000
89,000
....................
....................
2016
2016
....................
....................
7
3
7
3
10
10
....................
....................
Firms and FDA may realize savings from
sponsors choosing to submit electronic
RFDs
....................
....................
....................
....................
....................
....................
....................
....................
....................
7
....................
3
....................
....................
....................
....................
....................
....................
....................
....................
....................
From/To .....................................
From:
Other ..........................................
Annualized.
Monetized $millions/year ...........
....................
....................
....................
....................
7
....................
....................
....................
....................
....................
3
....................
From/To .....................................
From:
Notes
To:
To:
Effects:
State, Local or Tribal Government:
Small Business: Will not have a significant impact on a substantial number of small entities.
Wages:
Growth:
1 We
sradovich on DSK3GMQ082PROD with PROPOSALS
2 All
use a 10-year time horizon for this rule with payments occurring at the end of each period.
dollar values are rounded to the nearest $1,000.
Dated: June 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
POSTAL REGULATORY COMMISSION
39 CFR Part 3050
[FR Doc. 2018–12201 Filed 6–6–18; 8:45 am]
[Docket No. RM2018–5; Order No. 4630]
BILLING CODE 4164–01–P
Periodic Reporting
AGENCY:
ACTION:
VerDate Sep<11>2014
16:26 Jun 06, 2018
Jkt 244001
PO 00000
Postal Regulatory Commission.
The Commission is noticing a
recent filing requesting that the
Commission initiate an informal
rulemaking proceeding to consider
changes to an analytical method for use
in periodic reporting (Proposal Two).
This document informs the public of the
filing, invites public comment, and
takes other administrative steps.
SUMMARY:
Notice of proposed rulemaking.
Frm 00012
Fmt 4702
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07JNP1
]]>Agencies
[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Proposed Rules]
[Page 26392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12201]
[[Page 26392]]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 3
[Docket No. FDA-2004-N-0191]
Product Jurisdiction; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration is correcting a proposed rule
to amend its regulations concerning the classification of products as
biological products, devices, drugs, or combination products, and their
assignment to Agency components for premarket review and regulation
that appeared in the Federal Register of May 15, 2018. The document was
published with an error in the discussion of the preliminary economic
analysis impact. This document corrects that error.
DATES: Submit either electronic or written comments on the proposed
rule by July 16, 2018.
FOR FURTHER INFORMATION CONTACT: Melissa Burns, Office of Combination
Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 5129, Silver Spring, MD 20933, 301-796-8930,
[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, May 15,
2018, beginning on page 22428 for FR Doc. 2018-10321, table 1 on page
22433 is corrected to read:
Table 1--Benefits, Costs, and Distributional Effects of the Proposed Rule 1 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
---------------------------------------
Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
Annualized.......................... $17,000 $12,000 $27,000 2016 7 10 ................................
Monetized $/year.................... 15,000 10,000 23,000 2016 3 10 ................................
Annualized.......................... ........... ........... ........... ........... 7 ...........
Quantified.......................... ........... ........... ........... ........... 3 ...........
Qualitative......................... ........... ........... ........... ........... ........... ...........
Benefits:
Annualized.......................... 28,000 25,000 89,000 2016 7 10 ................................
Monetized $/year.................... 28,000 25,000 89,000 2016 3 10 ................................
Annualized.......................... ........... ........... ........... ........... 7 ........... ................................
Quantified.......................... ........... ........... ........... ........... 3 ........... ................................
---------------------------------------
Qualitative......................... Firms and FDA may realize savings ........... ........... ........... ................................
from sponsors choosing to submit
electronic RFDs
---------------------------------------
Transfers:
Federal............................. ........... ........... ........... ........... 7 ........... ................................
Annualized ........... ........... ........... ........... ........... ........... ................................
Monetized $millions/year............ ........... ........... ........... ........... 3 ........... ................................
------------------------------------------------------------------------------
From/To............................. From:
To:
------------------------------------------------------------------------------
Other............................... ........... ........... ........... ........... 7 ........... ................................
Annualized..........................
Monetized $millions/year............ ........... ........... ........... ........... 3 ........... ................................
------------------------------------------------------------------------------
From/To............................. From:
To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government:..................................................................................................................
Small Business: Will not have a significant impact on a substantial number of small entities........................................................
Wages:..............................................................................................................................................
Growth:.............................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ We use a 10-year time horizon for this rule with payments occurring at the end of each period.
\2\ All dollar values are rounded to the nearest $1,000.
Dated: June 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12201 Filed 6-6-18; 8:45 am]
BILLING CODE 4164-01-P
