Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices 7543 

1 Verizon and T-Mobile each filed corrections to 

PEAs 69 (Springfield, MA) and 282 (Galesburg, IL) 

indicating that Verizon is not reserve-eligible in 

those markets. The Commission agrees and 

accordingly, these corrections are reflected in 

Attachment 1. 

2 T-Mobile claims that Verizon should not be 

reserve-eligible in PEA 410 (Valentine, NE) based 

on arguments that Commission staff may not have 

attributed Alltel of Nebraska to Verizon, and TMobile’s own calculations of the population 

covered by Verizon’s cellular licenses in Valentine. 

The Commission notes first that the Commission 

did attribute Alltel of Nebraska to Verizon in our 

calculations. Secondly, in our review of the data 

submitted by T-Mobile, the Commission finds no 

basis for the inclusion of three additional census 

blocks in T-Mobile’s calculations of the population 

covered. The Commission finds that Verizon is 

reserve-eligible in Valentine. 

3 T-Mobile disagrees with our previously 

articulated methodology for determining reserveeligibility in PEAs in which there is a long-term 

spectrum lease. T-Mobile also advocates that the 

population-weighted megahertz number for each 

service provider in each PEA should be rounded up 

to the next whole number. These issues are beyond 

the scope of the corrections process set forth in the 

last Public Notice. 

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). 

The Auction 1000 Application 

Procedures Public Notice included a list 

of nationwide providers in each Partial 

Economic Area (‘‘PEA’’) qualified to bid 

on reserved spectrum in the forward 

auction (Auction 1002). The 

Commission stated in the Auction 1000 

Application Procedures Public Notice 

that an updated list of nationwide 

providers qualified to bid on reserved 

spectrum in Auction 1002 would be 

issued prior to the FCC Form 175 filing 

deadline. Parties interested in filing 

potential corrections were given until 

November 16, 2015 to do so, and two 

parties filed. 

The Wireless Telecommunications 

Bureau is releasing the updated list as 

Attachment 1 to this Public Notice. 

These updates reflect recently approved 

transactions and certain corrections 

requested by Verizon Wireless and TMobile,1 but do not reflect another 

correction 2 or certain changes in 

methodology requested by T-Mobile.3

PEAs that have been updated are 

marked in Attachment 1 with an 

asterisk. 

Federal Communications Commission. 

Joel Taubenblatt, 

Acting Deputy Bureau Chief, Wireless 

Telecommunications Bureau. 

[FR Doc. 2016–03058 Filed 2–11–16; 8:45 am] 

BILLING CODE 6712–01–P 

FEDERAL RESERVE SYSTEM 

Change in Bank Control Notices; 

Acquisitions of Shares of a Bank or 

Bank Holding Company 

The notificants listed below have 

applied under the Change in Bank 

Control Act (12 U.S.C. 1817(j)) and 

§ 225.41 of the Board’s Regulation Y (12 

CFR 225.41) to acquire shares of a bank 

or bank holding company. The factors 

that are considered in acting on the 

notices are set forth in paragraph 7 of 

the Act (12 U.S.C. 1817(j)(7)). 

The notices are available for 

immediate inspection at the Federal 

Reserve Bank indicated. The notices 

also will be available for inspection at 

the offices of the Board of Governors. 

Interested persons may express their 

views in writing to the Reserve Bank 

indicated for that notice or to the offices 

of the Board of Governors. Comments 

must be received not later than March 

1, 2016. 

A. Federal Reserve Bank of Chicago 

(Colette A. Fried, Assistant Vice 

President) 230 South LaSalle Street, 

Chicago, Illinois 60690–1414: 

1. Robert L. Chandonnet, 

individually, Muskegon, Michigan; to 

acquire voting shares of Community 

Shores Bank Corporation, and thereby 

indirectly acquire voting shares of 

Community Shores Bank, both in 

Muskegon, Michigan. 

Board of Governors of the Federal Reserve 

System, February 9, 2016. 

Michael J. Lewandowski, 

Associate Secretary of the Board. 

[FR Doc. 2016–02906 Filed 2–11–16; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–0363] 

Characterization of Ultrahigh Molecular 

Weight Polyethylene Used in 

Orthopedic Devices; Draft Guidance 

for Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Characterization of Ultrahigh 

Molecular Weight Polyethylene 

(UHMWPE) Used in Orthopedic 

Devices’’. The guidance identifies the 

types of UHMWPE currently in use in 

orthopedic implants, as well as the 

recommended information and testing 

that should be included in premarket 

submissions for such devices. This draft 

guidance is not final nor is it in effect 

at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment of this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by May 12, 2016. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to http://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on http://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Division of Dockets 

Management, FDA will post your 

comment, as well as any attachments, 

except for information submitted, 

marked and identified, as confidential, 

if submitted as detailed in 

‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2016–D–0363 for ‘‘Characterization of 


asabaliauskas on DSK9F6TC42PROD with NOTICES2
7544 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices 

Ultrahigh Molecular Weight 

Polyethylene (UHMWPE) Used in 

Orthopedic Devices.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at http://www.regulations.gov 

or at the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION’’. The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on http:// 

www.regulations.gov. Submit both 

copies to the Division of Dockets 

Management. If you do not wish your 

name and contact information to be 

made publicly available, you can 

provide this information on the cover 

sheet and not in the body of your 

comments and you must identify this 

information as ‘‘confidential.’’ Any 

information marked as ‘‘confidential’’ 

will not be disclosed except in 

accordance with 21 CFR 10.20 and other 

applicable disclosure law. For more 

information about FDA’s posting of 

comments to public dockets, see 80 FR 

56469, September 18, 2015, or access 

the information at: http://www.fda.gov/ 

regulatoryinformation/dockets/

default.htm. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to http://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

An electronic copy of the guidance 

document is available for download 

from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Characterization of 

Ultrahigh Molecular Weight 

Polyethylene (UHMWPE) Used in 

Orthopedic Devices’’ to the Office of the 

Center Director, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave. Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Peter Allen, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave. Bldg. 66, Rm. 1512, Silver Spring, 

MD 20993–0002, 301–796–6402. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry and FDA 

staff entitled ‘‘Characterization of 

Ultrahigh Molecular Weight 

Polyethylene (UHMWPE) Used in 

Orthopedic Devices’’. FDA has 

developed this guidance document for 

members of industry who submit, and 

FDA staff who review, information 

regarding orthopedic devices using 

UHMWPE material. This guidance is 

intended to provide recommendations 

when finalized regarding the 

characterization and testing of 

orthopedic devices that use UHMWPE 

materials such as conventional 

UHMWPE, highly crosslinked 

UHMWPE, and highly crosslinked 

UHMWPE containing vitamin E. This 

document also outlines the information 

FDA recommends industry include in a 

submission to FDA to characterize the 

UHMWPE material (e.g., material 

description, sterility, biocompatibility, 

mechanical properties, and chemical 

properties). 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on UHMWPE used in orthopedic 

devices. It does not establish any rights 

for any person and is not binding on 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the Internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Characterization of Ultrahigh 

Molecular Weight Polyethylene 

(UHMWPE) Used in Orthopedic 

Devices’’ may send an email request to 

CDRH-Guidance@fda.hhs.gov to receive 

an electronic copy of the document. 

Please use the document number 

1300006 to identify the guidance you 

are requesting. 

IV. Paperwork Reduction Act of 1995 

The guidance document 

‘‘Characterization of Ultrahigh 

Molecular Weight Polyethylene 

(UHMWPE) Used in Orthopedic 

Devices’’ refers to previously approved 

information collections found in FDA 

regulations and guidance. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 807, subpart E, are 

approved under OMB control number 

0910–0120; the collections of 

information in 21 CFR part 812 are 

approved under OMB control number 

0910–0078; the collections of 

information in 21 CFR part 814, 

subparts B and E, are approved under 

OMB control number 0910–0231; the 

collections of information in 21 CFR 

part 814, subpart H, are approved under 

OMB control number 0910–0332; and 

the collections of information in the 

guidance document entitled ‘‘Requests 

for Feedback on Medical Device 

Submissions: The Pre-Submission 

Program and Meetings with Food and 

Drug Administration Staff’’ are 

approved under OMB control number 

0910–0756. 

Dated: February 8, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–02879 Filed 2–11–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0115] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Manufactured 

Food Regulatory Program Standards 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 


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