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. 


sradovich on DSK3GMQ082PROD with PROPOSALS
Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Proposed Rules 26393 

1Petition of the United States Postal Service for 

the Initiation of a Proceeding to Consider Proposed 

Changes in Analytical Principles (Proposal Two), 

May 25, 2018 (Petition). 

2Petition at 1. The IOCS ‘‘is a continuous, 

ongoing probability sample of work time to estimate 

costs of various activities performed by clerks, mail 

handlers, city carriers, and supervisors.’’ See Docket 

No. ACR2017, Library Reference USPS–FY17–37, 

file ‘‘USPS–FY17–37.Preface.pdf,’’ at 2. 

3Petition, Proposal Two at 1. The Postal Service 

currently uses cost estimates from the IOCS to 

develop total accrued costs for both city carrier inoffice and street time. Id. 

4 Id. at 2, 4. ‘‘Zone is defined by both ZIP Code 

and finance number.’’ Id. at 4 n.5. 5 Id. at 5. All morning readings would begin when 

carriers start their workday and would continue 

until 11 a.m. Id. at 6. 6The Postal Service plans to synchronize IOCSCluster readings with City Carrier Cost System 

(CCCS) tests when a data collector is already 

scheduled to be at a delivery unit. 7All afternoon readings would be conducted 

between 11:00 and 19:00 hours. Id. at 6. 

8 Id. at 5. Instead, the Postal Service states that it 

will develop control total costs for Sunday/Holiday 

from TACS hours and distribute costs using 

scanning data from Product Tracking and Reporting 

(PTR). Id. at 5, 9. The Postal Service explains that 

it intends to file a separate proposal outlining the 

use of the PTR data for Sunday/Holiday costs. Id. 

at 5. 

DATES: Comments are due: July 16, 

2018. 

ADDRESSES: Submit comments 

electronically via the Commission’s 

Filing Online system at http://

www.prc.gov. Those who cannot submit 

comments electronically should contact 

the person identified in the FOR FURTHER

INFORMATION CONTACT section by 

telephone for advice on filing 

alternatives. 

FOR FURTHER INFORMATION CONTACT: 

David A. Trissell, General Counsel, at 

202–789–6820. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Introduction 

II. Proposal Two 

III. Notice and Comment 

IV. Ordering Paragraphs 

I. Introduction 

On May 25, 2018, the Postal Service 

filed a petition pursuant to 39 CFR 

3050.11 requesting that the Commission 

initiate a rulemaking proceeding to 

consider changes to analytical 

principles relating to periodic reports.1

The Petition identifies the proposed 

analytical changes filed in this docket as 

Proposal Two. 

II. Proposal Two 

Background. Proposal Two relates to 

new sampling and weighting procedures 

for the city carrier portion of the InOffice Cost System (IOCS).2 The current 

IOCS design uses a multi-stage 

probability sample to randomly select 

city carriers, then an interval of work 

time from the city carrier’s tour, 

resulting in an observation (‘‘reading’’) 

that represents a ‘‘snapshot’’ of work 

activity in a sampled interval.3 Under 

the current IOCS design, data collection 

for city carriers is widely dispersed in 

both time and location, so the Postal 

Service conducts most city carrier 

readings by telephone. The Postal 

Service states that the availability of 

detailed clock ring data from the Time 

and Attendance Collection System 

(TACS) and Delivery Operations 

Information System (DOIS) data now 

allows for a change to the current IOCS 

sampling design for city carriers. Id. at 

1–2. 

Proposal. The Postal Service proposes 

to change the current IOCS sample 

design for city carriers to a cluster 

sampling approach that would include 

using TACS workhours to weight the 

sampling data. Id. at 3–4. In the 

morning, on-site clustered city carrier 

readings would be conducted by an 

IOCS data collector, rather than with 

telephone respondents in sampled 

delivery zones.4 In zones with six or 

more routes (sampling mode 1), a 

maximum of six carriers would be 

randomly selected to represent the zone 

and morning readings would be taken 

on-site by the IOCS data collector once 

every 30 minutes.5 In zones with fewer 

than six city carriers working the 

selected zone (sampling mode 2), 

morning readings would be taken onsite by the IOCS data collector on all 

carriers once every 15 minutes.6 In the 

afternoon (sampling mode 3), all city 

carrier readings would be conducted by 

telephone and clustered into one-hour 

intervals.7

Under the cluster sampling design, 

the Postal Service proposes to use TACS 

workhours to weight sampling data by 

zone, and to provide cost controls for 

city carriers by time-of-day (morning 

and afternoon) and day-of-week group 

(weekday/Saturday group and Sunday/ 

Holiday group). Id. at 4–5. Additionally, 

the Postal Service states that it will use 

DOIS and TACS data for the sampled 

zone to weight the readings for each test 

relative to other tests within the same 

Cost Ascertainment Group (CAG) strata, 

and to post-stratify readings by route 

group and city carrier craft group. Id. at 

4, 7. However, the Postal Service states 

that all afternoon readings are scaled to 

the total hours in the afternoon and not 

estimated by CAG separately because it 

asserts that ‘‘there are insufficient 

afternoon tallies’’ and ‘‘no significant 

difference [for in-office cost] is 

expected’’ because carriers would be on 

the street. Id. at 7. 

The Postal Service asserts that the 

proposal adopts the approach suggested 

by the Commission in Order No. 4399 

for developing route group weighting 

factors when there were ‘‘empty cells’’ 

within the combination of route group 

and carrier group. Id. at 12. 

Proposal Two would also ‘‘[u]se 

TACS data to provide control totals for 

the portion of supervisor costs incurred 

by employees whose base craft is 

carrier, but who have clocked as 

supervisor.’’ Id. at 4. Additionally, 

unlike the current IOCS methodology, 

under the Proposal Two methodology, 

no IOCS readings would be conducted 

on Sundays and Holidays.8 However, 

for purposes of evaluating and 

presenting the estimated impact on FY 

2017 costs, the Postal Service ‘‘shows 

the effects of attributing all Sunday/ 

Holiday costs’’ to Parcel Select. Id. at 9. 

Rationale and impact. The Postal 

Service states that the primary objective 

of Proposal Two is to replace telephone 

readings with on-site readings, 

particularly while carriers are on the 

premises and handling mail. Id. at 10. 

The Postal Service projects that the 

IOCS-Cluster system will obtain twice 

as much on-premises data as the current 

system, but ‘‘due to the improvement in 

sampling efficiency, will not require 

additional data collection resources.’’ 

Id. at 8. Further, the Postal Service 

asserts that ‘‘[t]he new design improves 

data quality by obtaining far more data 

from on-site rather than telephone 

readings, while simultaneously 

improving data collection efficiency.’’ 

Id. at 1. 

The Postal Service lists several 

benefits of the proposal including the 

ability to scan barcodes, providing 

feedback at the time of the reading for 

less-common products and assisting 

with ‘‘back-end processing of tallies.’’ 

Id. at 10. Additionally, the Postal 

Service states that on-site data collectors 

may do a better job than a telephone 

respondent of recognizing some of the 

mailpiece markings that are less 

common and more obscure. Id. Further, 

unlike city carrier telephone 

respondents, under Proposal Two, onsite IOCS data collectors would not have 

other duties that may affect and 

constrain participating in a reading 

under the current IOCS sampling 

system. Id. 

The Postal Service states that the 

proposal will result in a significant 

increase in the percentage of direct 

tallies where the carrier is handling the 

mailpiece, and decreases in tallies for 

support and administrative activities, 

training, and mixed mail. Id. at 12. The 

Postal Service also anticipates a 


sradovich on DSK3GMQ082PROD with PROPOSALS
26394 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Proposed Rules 

9 Id. at 14. The pilot data showed a 9.1-percent 

increase in supervisor city carrier costs, which 

resulted in a slight increase in piggyback factors on 

city carrier costs. Id. 

significant increase in tallies in the 

parking area, potentially making it 

possible to distribute mixed mail tallies 

separately from in-facility. Id. at 13. 

The Postal Service states that the pilot 

data indicate some significant shifts in 

product costs, including a decrease in 

costs for First-Class letters, and 

increases in costs for a number of 

products including parcel-shaped 

products, carrier route bundled 

products, Periodicals, and International 

Mail. Id. at 14–15. The Postal Service 

asserts that the shifts in product costs 

are most likely due to the use of on-site 

data collectors rather than telephone 

respondents. Id. at 15. The proposal 

would also impact costs associated with 

supervising city carriers.9

The Postal Service’s estimate of the 

effect on product unit costs is presented 

in Table 5 of Proposal Two, which is 

reproduced here. Id. at 16. 

BILLING CODE 7710–FW–P 


sradovich on DSK3GMQ082PROD with PROPOSALS
Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Proposed Rules 26395 

BILLING CODE 7710–FW–C 

III. Notice and Comment 

The Commission establishes Docket 

No. RM2018–5 for consideration of 

matters raised by the Petition. More 

information on the Petition may be 

accessed via the Commission’s website 

at http://www.prc.gov. Interested 

persons may submit comments on the 

Petition and Proposal Two no later than 

July 16, 2018. Pursuant to 39 U.S.C. 505, 

Lyudmila Y. Bzhilyanskaya is 

designated as an officer of the 

Commission (Public Representative) to 

represent the interests of the general 

public in this proceeding. 

IV. Ordering Paragraphs 

It is ordered: 

1. The Commission establishes Docket 

No. RM2018–5 for consideration of the 

matters raised by the Petition of the 


sradovich on DSK3GMQ082PROD with PROPOSALSEP07JN18.004</GPH>

.,., .... _.,., 

- ·.::.:-.- .. _- _;-

GOD 

CRA 

Class 

I 

11l 

so 

21 

31 

4.2 

43 

44 

83 

85 

:5i 

62 

54 

55 

58 

OfFI ~= -~~,[! 

STREET ~·~LTH 

PIGGYBACKS 

Noeusb!r 

J!t72:;1B 

t8..871 

4tO.tll7 

4t1.800 

,. --,~ : .:.-

1lrnl 

78.7DB 

C•FF CE ~.N [) 

.5-I.i.EE: ·:.~ ~ :l-F 

PIGGYBACKS 

IOCSCllsb!IV2 

'- )42 

-,_ ~17 

86..421 

. r:: 53J 

'!(, 

CHANGE 

OFRCE 

AND 

STREET 

COSTS 

-10% 

FY17 

VOL II~.R 

UNT 

COST. 

FY17 

ACR 

14· 

t 

~ 0.316 

1% $ 1.0'' 

-12% $ 1]2_--

11 '• ~ a. 110 

~ n 1111 

3% 

17% :s- o.r: 

72% i [Ui:" 

39% s o_g-· 

21% :s- 3. r-: 

-5% 

39% $ 2.4;: 

fi~? Ul!.1 

COST WITH 

IIOCSCllsb!Nl! 

(15) 

J 

s 0:21[1 

s O.t111 

s otm 

s 0.400 

s t 7!i!i. 

S Oll!'in 

s 6..764 

% 

CHANGE 

6.2% 

1:1.2% 

:15% 

-J.6% 

6.J% 

= -'ll· 

- '": 

1.2% 

4.9".{. 

10.7% 

1.2% 

6.7% 

1.0% 

4.8% 

DIFF UNIT 

COST 

i n mR 

$ 0.027 

$ 0.005 

i D om 

$ 0.018 

$ []_008 

$ 0.104 

$ D.05!l 

$ 0.023 

:l O.C8~ 

.:;: 0.1:::::. 

$ 0.031 

$(!12!51) 

$ D.117 
26396 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Proposed Rules 

United States Postal Service for the 

Initiation of a Proceeding to Consider 

Proposed Changes in Analytical 

Principles (Proposal Two), filed May 25, 

2018. 

2. Comments by interested persons in 

this proceeding are due no later than 

July 16, 2018. 

3. Pursuant to 39 U.S.C. 505, the 

Commission appoints Lyudmila Y. 

Bzhilyanskaya to serve as an officer of 

the Commission (Public Representative) 

to represent the interests of the general 

public in this docket. 

4. The Secretary shall arrange for 

publication of this order in the Federal 

Register. 

By the Commission. 

Ruth Ann Abrams, 

Acting Secretary. 

[FR Doc. 2018–12200 Filed 6–6–18; 8:45 am] 

BILLING CODE 7710–FW–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 1 and 27 

[WT Docket No. 18–120; FCC 18–59] 

Transforming the 2.5 GHz Band 

AGENCY: Federal Communications 

Commission. 

ACTION: Proposed rule. 

SUMMARY: In this document, the Federal 

Communications Commission 

(Commission or FCC) seeks comment on 

proposed service rules on the 2.5 GHz 

band and on refinements to the adopted 

rules in this document. 

DATES: Comments are due on or before 

July 9, 2018; reply comments are due on 

or before August 6, 2018. 

ADDRESSES: You may submit comments, 

identified by WT Docket No. 18–120, by 

any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Federal Communications 

Commission’s Website: https://

www.fcc.gov/ecfs/filings. Follow the 

instructions for submitting comments. 

• People With Disabilities: Contact 

the FCC to request reasonable 

accommodations (accessible format 

documents, sign language interpreters, 

CART, etc.) by email: FCC504@fcc.gov, 

phone: 202–418–0530 or TTY: 202–418– 

0432. 

For detailed instructions for 

submitting comments and additional 

information on the rulemaking process, 

see the SUPPLEMENTARY INFORMATION

section of this document. 

FOR FURTHER INFORMATION CONTACT: John 

J. Schauble of the Wireless 

Telecommunications Bureau, 

Broadband Division, at 202–418–0797 

or by email to John.Schauble@fcc.gov. 

For information regarding the PRA 

information collection requirements 

contained in this PRA, contact Cathy 

Williams, Office of Managing Director, 

at (202) 418–2918 or Cathy.Williams@

fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Notice of 

Proposed Rulemaking, WT Docket No. 

18–120, FCC 18–59, adopted and 

released on May 10, 2018. The complete 

text of this document is available for 

public inspection and copying from 8 

a.m. to 4:30 p.m. Eastern Time (ET) 

Monday through Thursday or from 8 

a.m. to 11:30 a.m. ET on Fridays in the 

FCC Reference Information Center, 445 

12th Street SW, Room CY–A257, 

Washington, DC 20554. The complete 

text is available on the Commission’s 

website at http://wireless.fcc.gov, or by 

using the search function on the ECFS 

web page at http://www.fcc.gov/cgb/ 

ecfs/. Alternative formats are available 

to persons with disabilities by sending 

an email to fcc504@fcc.gov or by calling 

the Consumer & Governmental Affairs 

Bureau at (202) 418–0530 (voice), (202) 

418–0432 (tty). 

Comment Filing Procedures 

Pursuant to §§ 1.415 and 1.419 of the 

Commission’s rules, 47 CFR 1.415, 

1.419, interested parties may file 

comments and reply comments on or 

before the dates indicated on the first 

page of this document. Comments may 

be filed using the Commission’s 

Electronic Comment Filing System 

(ECFS). See Electronic Filing of 

Documents in Rulemaking Proceedings, 

63 FR 24121 (1998). 

• Electronic Filers: Comments may be 

filed electronically using the internet by 

accessing the ECFS: https://

www.fcc.gov/ecfs/filings. Filers should 

follow the instructions provided on the 

website for submitting comments. In 

completing the transmittal screen, filers 

should include their full name, U.S. 

Postal Service mailing address, and the 

applicable docket number, WT Docket 

No. 18–120. 

• Paper Filers: Parties who choose to 

file by paper must file an original and 

one copy of each filing. If more than one 

docket or rulemaking number appears in 

the caption of this proceeding, filers 

must submit two additional copies for 

each additional docket or rulemaking 

number. 

Filings can be sent by hand or 

messenger delivery, by commercial 

overnight courier, or by first-class or 

overnight U.S. Postal Service mail. All 

filings must be addressed to the 

Commission’s Secretary, Office of the 

Secretary, Federal Communications 

Commission. 

• All hand-delivered or messengerdelivered paper filings for the 

Commission’s Secretary must be 

delivered to FCC Headquarters at 445 

12th St. SW, Room TW–A325, 

Washington, DC 20554. The filing hours 

are 8:00 a.m. to 7:00 p.m. All hand 

deliveries must be held together with 

rubber bands or fasteners. Any 

envelopes and boxes must be disposed 

of before entering the building. 

• Commercial overnight mail (other 

than U.S. Postal Service Express Mail 

and Priority Mail) must be sent to 9050 

Junction Dr., Annapolis Junction, 

Annapolis, MD 20701. 

• U.S. Postal Service first-class, 

Express, and Priority mail must be 

addressed to 445 12th Street SW, 

Washington, DC 20554. 

People With Disabilities: To request 

materials in accessible formats for 

people with disabilities (braille, large 

print, electronic files, audio format), 

send an email to fcc504@fcc.gov or call 

the Consumer & Governmental Affairs 

Bureau at 202–418–0530 (voice), 888– 

835–5322 (tty). 

Ex Parte Rules—Permit-But-Disclose 

Pursuant to § 1.1200(a) of the 

Commission’s rules, this NPRM shall be 

treated as a ‘‘permit-but-disclose’’ 

proceeding in accordance with the 

Commission’s ex parte rules. Persons 

making ex parte presentations must file 

a copy of any written presentation or a 

memorandum summarizing any oral 

presentation within two business days 

after the presentation (unless a different 

deadline applicable to the Sunshine 

period applies). Persons making oral ex 

parte presentations are reminded that 

memoranda summarizing the 

presentation must (1) list all persons 

attending or otherwise participating in 

the meeting at which the ex parte 

presentation was made, and (2) 

summarize all data presented and 

arguments made during the 

presentation. If the presentation 

consisted in whole or in part of the 

presentation of data or arguments 

already reflected in the presenter’s 

written comments, memoranda or other 

filings in the proceeding, the presenter 

may provide citations to such data or 

arguments in his or her prior comments, 

memoranda, or other filings (specifying 

the relevant page and/or paragraph 

numbers where such data or arguments 

can be found) in lieu of summarizing 

them in the memorandum. Documents 


sradovich on DSK3GMQ082PROD with PROPOSALS