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. 

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, 

melissa.burns@fda.hhs.gov. 

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

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(%) 

Period 

covered 

(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: 

1We use a 10-year time horizon for this rule with payments occurring at the end of each period. 

2All 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 

POSTAL REGULATORY COMMISSION 

39 CFR Part 3050 

[Docket No. RM2018–5; Order No. 4630] 

Periodic Reporting 

AGENCY: Postal Regulatory Commission. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: 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. 


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