Characterization of Ultrahigh Molecular Weight Polyethylene Used in Orthopedic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 7543-7544 [2016-02879]

Download as PDF Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices FEDERAL RESERVE SYSTEM Federal Communications Commission. Joel Taubenblatt, Acting Deputy Bureau Chief, Wireless Telecommunications Bureau. Board of Governors of the Federal Reserve System, February 9, 2016. Michael J. Lewandowski, Associate Secretary of the Board. [FR Doc. 2016–03058 Filed 2–11–16; 8:45 am] [FR Doc. 2016–02906 Filed 2–11–16; 8:45 am] BILLING CODE 6712–01–P asabaliauskas on DSK9F6TC42PROD with NOTICES2 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. BILLING CODE 6210–01–P 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. VerDate Sep<11>2014 17:38 Feb 11, 2016 Jkt 238001 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. 7543 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 Food and Drug Administration Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://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’’). [Docket No. FDA–2016–D–0363] Written/Paper Submissions DEPARTMENT OF HEALTH AND HUMAN SERVICES 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. 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 SUMMARY: PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 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 E:\FR\FM\12FEN1.SGM 12FEN1 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 https://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 https:// 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: https://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 https:// 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 VerDate Sep<11>2014 17:38 Feb 11, 2016 Jkt 238001 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 https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 at https://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. The Food and Drug Administration (FDA) is announcing an SUMMARY: E:\FR\FM\12FEN1.SGM 12FEN1

Agencies

[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Notices]
[Pages 7543-7544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02879]


=======================================================================
-----------------------------------------------------------------------

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: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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

[[Page 7544]]

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 https://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 https://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: https://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 https://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 self-addressed 
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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at https://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
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.