Product Jurisdiction; Correction
Federal Register, Volume 83 Issue 110 (Thursday, June 7, 2018)
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.
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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
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Units
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Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
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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 ........... ................................
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Qualitative......................... Firms and FDA may realize savings ........... ........... ........... ................................
from sponsors choosing to submit
electronic RFDs
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Transfers:
Federal............................. ........... ........... ........... ........... 7 ........... ................................
Annualized ........... ........... ........... ........... ........... ........... ................................
Monetized $millions/year............ ........... ........... ........... ........... 3 ........... ................................
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From/To............................. From:
To:
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Other............................... ........... ........... ........... ........... 7 ........... ................................
Annualized..........................
Monetized $millions/year............ ........... ........... ........... ........... 3 ........... ................................
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From/To............................. From:
To:
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Effects:
State, Local or Tribal Government:..................................................................................................................
Small Business: Will not have a significant impact on a substantial number of small entities........................................................
Wages:..............................................................................................................................................
Growth:.............................................................................................................................................
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\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
