[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Notices]
[Pages 22496-22497]
[FR Doc No: 2018-10337]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1577]

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory
Committee; Notice of Meeting; Establishment of a Public Docket; Request
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Pediatric Oncology
Subcommittee of the Oncologic Drugs Advisory Committee. The general
function of the committee is to provide advice and recommendations to
FDA on regulatory issues. The meeting will be open to the public. FDA
is establishing a docket for public comment on this document.

DATES: The meeting will be held on June 20, 2018, from 8 a.m. to 4:30
p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2018-N-1577. The docket will close on June 19,
2018. Submit either electronic or written comments on this public
meeting by June 19, 2018. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before June 19, 2018. The https://www.regulations.gov electronic
filing system will accept comments until midnight Eastern Time at the
end of June 19, 2018. Comments received by mail/hand delivery/courier
(for written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.
    Comments received on or before June 5, 2018, will be provided to
the committee. Comments received after that date will be taken into
consideration by FDA.
    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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2018-N-1577 for ``Pediatric Oncology Subcommittee of the Oncologic
Drugs Advisory Committee; Notice of Meeting; Establishment of a Public
Docket; Request for Comments.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
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.'' FDA 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 Dockets Management Staff. If you do not wish your name
and contact information 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 the 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lauren D. Tesh, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax:<PHONE_NUMBER>, email: [email protected]; or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The particular matter for this meeting will be review and
discussion of a list of molecular targets for which evidence and/or
biologic rationale exist to determine their potential relevance to the
growth or progression of one or more pediatric cancers and a list of
those targets deemed unlikely to be associated with the growth or
progression of pediatric tumors. These lists are expected to fulfill
the statutory obligation of the Food and Drug Administration
Reauthorization Act (FDARA) and provide some guidance to industry in
planning for initial Pediatric Study Plan submissions for new drug and/
or biologic products in development for cancer in accordance with the
amended provisions of the Pediatric Research Equity Act. The committee
will review and discuss considerations other than scientific relevance
that FDA will include in decision making with respect to the need and
timing of pediatric evaluation of specific new drug and biologic
products. The committee will discuss possible criteria and mechanisms
for the prioritization by sponsors and the clinical investigator
community of select targeted new agents for pediatric evaluation
especially in the setting of multiple same in class agents. Preliminary
discussion will focus on approaches to coordination and collaboration
for pediatric clinical investigations of new agents that might be
pursued to efficiently accommodate international regulatory
requirements and global pediatric product development. The open public
hearing sessions are: Topic 1: Target List, Topic 2: FDARA
Implementation, and Topic 3: Mechanisms to Assure Efficiency and to
Enhance Global Coordination Through International Collaboration.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the subcommittee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before June 5, 2018, will be provided to the
subcommittee. Oral presentations from the public will be scheduled
between approximately 10:25 a.m. and 10:45 a.m., 1:40 p.m. and 2 p.m.,
and 3:40 p.m. and 4:30 p.m. Those individuals interested in making
formal oral presentations should notify the contact person and submit a
brief statement of the general nature of the evidence or arguments they
wish to present, the names and addresses of proposed participants, and
an indication of the approximate time requested to make their
presentation on or before May 25, 2018. Time allotted for each
presentation may be limited. If the number of registrants requesting to
speak is greater than can be reasonably accommodated during the
scheduled open public hearing session, FDA may conduct a lottery to
determine the speakers for the scheduled open public hearing session.
The contact person will notify interested persons regarding their
request to speak by May 29, 2018.
    Persons attending FDA's advisory committee meetings are advised
that FDA is not responsible for providing access to electrical outlets.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Lauren D. Tesh (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: May 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10337 Filed 5-14-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Notices]
[Pages 7543-7544]
[FR Doc No: 2016-02879]

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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.

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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

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 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,<PHONE_NUMBER>.

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<EMAIL_ADDRESS>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


[Federal Register Volume 82, Number 120 (Friday, June 23, 2017)]
[Notices]
[Pages 28652-28653]
[FR Doc No: 2017-13088]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-46-000]

Southern Natural Gas Company, LLC; Notice of Schedule for
Environmental Review of the Fairburn Expansion Project

    On February 3, 2017, Southern Natural Gas Company, LLC (Southern)
filed an application in Docket No. CP17-46-000 requesting a Certificate
of Public Convenience and Necessity pursuant to section 7(c) of the
Natural Gas Act to construct and operate certain natural gas pipeline
facilities. The proposed project is known as the Fairburn Expansion
Project, and would add 343,164 dekatherms per day of firm
transportation service to its existing pipeline system.
    On February 17, 2017 the Federal Energy Regulatory Commission
(Commission or FERC) issued its Notice of Application for the Project.
Among

other things, that notice alerted agencies issuing federal
authorizations of the requirement to complete all necessary reviews and
to reach a final decision on a request for a federal authorization
within 90 days of the date of issuance of the Commission staff's
Environmental Assessment (EA) for the Project. This instant notice
identifies the FERC staff's planned schedule for the completion of the
EA for the Project.

Schedule for Environmental Review

    Issuance of EA: August 18, 2017.
    90-day Federal Authorization Decision Deadline: November 16, 2017.
    If a schedule change becomes necessary, additional notice will be
provided so that the relevant agencies are kept informed of the
Project's progress.

Project Description

    Southern would upgrade and construct certain compression and
pipeline facilities in Fayetteville and Fulton Counties, Georgia
(including installing a new 4.9-mile-long 30-inch-diameter Fairburn
Lateral and the new 18,000-horsepower electric Fairburn Compressor
Station); and Clayton and Cobb Counties Georgia.

Background

    On March 20, 2017, the Commission issued a Notice of Intent To
Prepare an Environmental Assessment for the Proposed Fairburn Expansion
Project and Request for Comments on Environmental Issues (NOI). The NOI
was sent to affected landowners; federal, state, and local government
agencies; elected officials; environmental and public interest groups;
Native American tribes; other interested parties; and local libraries
and newspapers. In response to the NOI, the Commission received
comments from the U.S. Environmental Protection Agency (EPA) and five
landowners. The primary issues raised by the commentors are safety and
residential impacts during construction, and operational safety in
association with electric power line collocation.
    The EPA and the U.S. Army Corps of Engineers are cooperating
agencies in the preparation of the EA.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. This can
reduce the amount of time you spend researching proceedings by
automatically providing you with notification of these filings,
document summaries, and direct links to the documents. Go to
www.ferc.gov/docs-filing/esubscription.asp.
    Additional information about the Project is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC Web site (www.ferc.gov). Using the eLibrary link, select General
Search from the eLibrary menu, enter the selected date range and Docket
Number excluding the last three digits (i.e., CP17-47), and follow the
instructions. For assistance with access to eLibrary, the helpline can
be reached at<PHONE_NUMBER>, TTY<PHONE_NUMBER>, or at
<EMAIL_ADDRESS>The eLibrary link on the FERC Web site also
provides access to the texts of formal documents issued by the
Commission, such as orders, notices, and rule makings.

    Dated: June 16, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-13088 Filed 6-22-17; 8:45 am]
 BILLING CODE 6717-01-P