[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Pages 57003-57004]
[FR Doc No: 2015-23524]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3224]

Request for Nominations for Voting Members for the Patient
Engagement Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for members to serve on the Patient Engagement Advisory
Committee (the Committee), Office of the Center Director, Center for
Devices and Radiological Health.
    FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore, encourages nominations of
appropriately qualified candidates from these groups.

DATES: Nominations received by November 20, 2015, will be given first
consideration for membership on the Committee. Nominations received
after November 20, 2015, will be considered for nomination to the
Committee as later vacancies occur.

ADDRESSES: All nominations for membership should be sent electronically
by logging into the FDA Advisory Committee Membership Nomination
Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, by mail to Advisory Committee Oversight and Management
Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 5103, Silver Spring, MD 20993-0002, or by FAX:<PHONE_NUMBER>.
Information about becoming a member on an FDA advisory committee can
also be obtained by visiting FDA's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm

FOR FURTHER INFORMATION CONTACT: Letise Williams, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5441,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members for the Committee.
    Elsewhere in this issue of the Federal Register, FDA is publishing
separate documents regarding:
    1. Patient Engagement Advisory Committee; Notice of Establishment.
    2. Request for Nominations of Individuals and Industry
Organizations for the Patient Engagement Advisory Committee.
    3. Request for Nominations of Individuals and Consumer
Organizations for the Patient Engagement Advisory Committee.

I. General Description of the Committee's Duties

    The Committee provides advice on complex issues relating to medical
devices, the regulation of devices, and their use by patients. Agency
guidance

and policies, clinical trial or registry design, patient preference
study design, benefit-risk determinations, device labeling, unmet
clinical needs, available alternatives, patient reported outcomes and
device-related quality of life or health status issues are among the
topics that may be considered by the Committee. Members are
knowledgeable in areas such as clinical research, primary care patient
experience, healthcare needs of patient groups in the United States, or
are experienced in the work of patient and health professional
organizations, methodologies for eliciting patient preferences, and
strategies for communicating benefits, risks, and clinical outcomes to
patients and research subjects.

II. Criteria for Voting Members

    The Committee consists of a core of nine voting members including
the Chair. Members and the Chair are selected by the Commissioner of
Food and Drugs or designee from among authorities who are knowledgeable
in areas such as clinical research, primary care patient experience,
healthcare needs of patient groups in the United States, or are
experienced in the work of patient and health professional
organizations, methodologies for eliciting patient preferences, and
strategies for communicating benefits, risks, and clinical outcomes to
patients and research subjects. Members will be invited to serve for
overlapping terms of up to 4 years. Prospective members should also
have an understanding of the broad spectrum of patients in a particular
disease area. Almost all non-Federal members of this Committee serve as
Special Government Employees.

III. Nomination Procedures

    Any interested person may nominate one or more qualified
individuals for membership on the Committee. Self-nominations are also
accepted. Nominations should include a cover letter; a current,
complete resume or curriculum vitae for each nominee, including a
current business and/or home address, telephone number, and email
address if available; and should specify the advisory committee for
which the nominee is recommended. Nominations should also acknowledge
that the nominee is aware of the nomination, unless self-nominated. FDA
will ask potential candidates to provide detailed information
concerning such matters related to financial holdings, employment, and
research grants and/or contracts to permit evaluation of possible
sources of conflicts of interest.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: September 15, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-23524 Filed 9-18-15; 8:45 am]
BILLING CODE P


[Federal Register Volume 79, Number 79 (Thursday, April 24, 2014)]
[Notices]
[Pages 22825-22826]
[FR Doc No: 2014-09290]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2013-1065]

Towing Safety Advisory Committee; June 2014 Meeting

AGENCY: Coast Guard, DHS.

ACTION: Notice of teleconference meeting.

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SUMMARY: The Towing Safety Advisory Committee (TSAC) will meet via
teleconference to receive tasking related to the report of
investigation into the Mobile Offshore Drilling Unit (MODU) KULLUK
grounding incident and receive final reports or status reports from
seven active TSAC Subcommittees. This meeting will be open to the
public.

DATES: The teleconference will take place on Wednesday, June 4, 2014,
from 1 p.m. to 3 p.m. EST. This meeting may close early if all business
is finished. If you wish to make oral comments at the teleconference,
notify Mr. William J. Abernathy before the teleconference, as specified
in the FOR FURTHER INFORMATION CONTACT section, or the designated Coast
Guard staff at the meeting. If you wish to submit written comments or
make a presentation, submit your comments or request to make a
presentation by May 28, 2014. Also, if you want to come to the
teleconference host location in person, you must request building
access by May 28, 2014.

ADDRESSES: The Committee will meet via teleconference. To participate
by phone, please contact Mr. William J. Abernathy listed below in the
FOR FURTHER INFORMATION CONTACT section to obtain teleconference
information. Note the number of teleconference lines is limited and
will be available on a first-come, first-served basis. To come to the
host location in person and join those participating in this
teleconference from U.S. Coast Guard Headquarters, 2703 Martin Luther
King Jr. Ave. SE., Washington, DC 20593-7509, please contact Mr.
William J. Abernathy listed in the FOR FURTHER INFORMATION CONTACT
section to request directions and building access. You must request
building access by May 28, 2014, and present a valid, government-issued
photo identification to gain entrance to the Coast Guard Headquarters
building.
    For information on facilities or services for individuals with
disabilities or to request special assistance at the teleconference,
contact Mr. William J. Abernathy listed in the FOR FURTHER INFORMATION
CONTACT section, as soon as possible.
    If you want to make a presentation, send your request by May 28,
2014, to Mr. William J. Abernathy listed in the FOR FURTHER INFORMATION
CONTACT section. To facilitate public participation we are inviting
public comment on the issues to be considered by the Committee as
listed in the ``Agenda'' section below. You may submit a written
comment on or before May 28, 2014, or make an oral comment during the
public comment portion of the teleconference.
    To submit a comment in writing, use one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     Email<EMAIL_ADDRESS>Include the docket
number (USCG-2013-1065) on the subject line of the message.
     Fax:<PHONE_NUMBER>. Include the docket number (USCG-2013-
1065) on the subject line of the fax.
     Mail: Docket Management Facility (M-30), U.S. Department
of Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Same as mail address above, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays. The
telephone number is<PHONE_NUMBER>.
     To avoid duplication, please use only one of these
methods.
    Instructions: All submissions received must include the words
``Department of Homeland Security'' and the docket number for this
notice. All comments received will be posted without alteration at
http://www.regulations.gov, including any personal information
provided. You may review a Privacy Act notice regarding our public
dockets in the January 17, 2008, issue of the Federal Register (73 FR
3316).
    Docket: For access to the docket to read documents or comments
related to this Notice, go to http://www.regulations.gov, insert USCG-
2013-1065 in the Search box, press Enter, and then click on the item
you wish to view.

FOR FURTHER INFORMATION CONTACT: Lieutenant Commander William Nabach,
Alternate Designated Federal Official (ADFO) of TSAC, Commandant (CG-
OES-2), U.S. Coast Guard, 2703 Martin Luther King Jr. Ave. SE., Stop
7509, Washington, DC 20593-7509; telephone<PHONE_NUMBER>, fax (202)
372-8283 or Mr. William J. Abernathy, Alternate Designated Federal
Official (ADFO) of TSAC, Commandant (CG-OES-2), U.S. Coast Guard, 2703
Martin Luther King Jr. Avenue SE. If you have questions on viewing or
submitting material to the docket, call Cheryl Collins, Program
Manager, Docket Operations, telephone<PHONE_NUMBER> or 1-800-647-5527.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act (FACA), 5 U.S.C. App., Public Law 92-
463, 86 Stat. 770. As stated in 33 U.S.C. 1231a, the Towing Safety
Advisory Committee provides advice and recommendations to the
Department of Homeland Security on matters relating to shallow-draft
inland and coastal waterway navigation and towing safety.

Agenda of Meeting

    The agenda for the June 4, 2014, teleconference includes:
    (1) Assignment of new tasking to the Committee for recommendations
on the U.S. Coast Guard's Report Of Investigation (ROI) into the MODU
KULLUK grounding incident.
    (2) Receive the draft final report from the Subcommittee on
Recommendations for Designation of Narrow Channels.
    (3) Status updates from the following Subcommittees:
    (a) Recommendations Regarding Manning of Inspected Towing Vessels.
    (b) Recommendations for Evaluating Placement of Structures Adjacent
to or Within the Navigable Channel.
    (c) Recommendations for the Maintenance, Repair and Utilization of
Towing Equipment, Lines and Couplings.
    (d) Recommendations for Mid-Stream Liquefied Natural Gas and
Compressed Natural Gas Refueling of Towing Vessels.
    (e) Recommendations for Improvement of Coast Guard Marine Casualty
Reporting.
    (f) Recommendations to Establish Criteria for Identification of Air
Draft for Towing Vessels and Tows.
    (4) TSAC member comments.
    (5) Public comments.
    There will be a comment period for TSAC and a comment period for
the

public after each final report, but before each recommendation is
formulated. The Committee will review the information presented on each
issue, deliberate on any recommendations presented in the
Subcommittees' reports, and formulate recommendations for the
Department's consideration. A copy of each draft report and the final
agenda will be available at https://homeport.uscg.mil/tsac.
    During the June 4, 2014, teleconference, a public comment period
will be held from approximately 2:45 p.m. to 3 p.m. Speakers are
requested to limit their comments to three minutes. Please note that
this public comment period may start before 2:45 p.m. if all other
agenda items have been covered and may end before 3 p.m. if all of
those wishing to comment have done so. Please contact Mr. William J.
Abernathy, listed in the FOR FURTHER INFORMATION CONTACT section to
register as a speaker.

Minutes

    Minutes from the meeting will be available for public review and
copying within 30 days following the meeting at https://homeport.uscg.mil/tsac.

Notice of Future 2014 TSAC Meetings

    To receive automatic email notices of future TSAC meetings in 2014,
go to the online docket, USCG-2013-1065 (http://www.regulations.gov/#!docketDetail;D=USCG-2013-1065), and select the sign-up-for-email-
alerts option. We plan to use the same docket number for all TSAC
meeting notices in 2014, so when the next meeting notice is published
you will receive an email alert from http://www.regulations.gov when
the notice appears in this docket.

J.G. Lantz,
Director of Commercial Regulations and Standards.
[FR Doc. 2014-09290 Filed 4-23-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 216 (Thursday, November 7, 2013)]
[Notices]
[Pages 66986-66987]
[FR Doc No: 2013-26723]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Opportunity for Public Comment on Surplus Property
Release at Barnwell County Airport, Barnwell, South Carolina

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: Under the provisions of Title 49, U.S.C. 47151(d), notice is
being given that the Federal Aviation Administration (FAA) is
considering a request from the County of Barnwell to waive the
requirement that a 4.0 acre

parcel of surplus property, located at the Barnwell County Airport be
used for aeronautical purposes. Currently, ownership of the property
provides for protection of FAR Part 77 surfaces and compatible land use
which would continue to be protected with deed restrictions required in
the transfer of land ownership.

DATES: Comments must be received on or before December 9, 2013.

ADDRESSES: Documents are available for review by prior appointment at
the following location: Atlanta Airports District Office, Attn: Rob
Rau, South Carolina Planner, 1701 Columbia Ave., Suite 2-260, College
Park, Georgia 30337-2747, Telephone:<PHONE_NUMBER>.
    Comments on this notice may be mailed or delivered in triplicate to
the FAA at the following address: Atlanta Airports District Office,
Attn: Rob Rau, South Carolina Planner, 1701 Columbia Ave., Suite 2-260,
College Park, Georgia 30337-2747.
    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to Pickens Williams Jr., County Administrator,
Barnwell County at the following address: County Administration
Building, 57 Wall Street, Room 126, Barnwell, South Carolina 29812.

FOR FURTHER INFORMATION CONTACT: Rob Rau, South Carolina Planner,
Atlanta Airports District Office, 1701 Columbia Ave., Suite 2-260,
College Park, Georgia 30337-2747,<PHONE_NUMBER>. The application may
be reviewed in person at this same location.

SUPPLEMENTARY INFORMATION: The FAA is reviewing a request by the County
of Barnwell to release 4.0 acres of surplus property at the Barnwell
County Airport. This property was originally conveyed to the County of
Barnwell on April 2, 1947 under the powers and authority contained in
the provisions of the Surplus Property Act of 1944. Currently, the
surplus property is being used for a senior citizens center.
    Any person may inspect the request in person at the FAA office
listed above under FOR FURTHER INFORMATION CONTACT. In addition, any
person may, upon request, inspect the request, notice and other
documents germane to the request in person at the Charleston
International Airport.

    Issued in Atlanta, Georgia, on October 30, 2013.
Gene Roth,
Acting Manager, Atlanta Airports District Office Southern Region.
[FR Doc. 2013-26723 Filed 11-6-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: April 5, 2010 (Volume 75, Number 64)]
[Rules and Regulations]
[Page 17052-17055]
[DOCID:fr05ap10-9]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 740, 748, 750, and 762

[Docket No.<PHONE_NUMBER>-0114-02]
RIN 0694-AE66

Issuance of Electronic Documents and Related Recordkeeping
Requirements

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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SUMMARY: This rule enables BIS to eliminate the paper versions of most
export and reexport licenses, notices of denial of license
applications, notices of return of a license application without
action, notices of results of classification requests, License
Exception AGR notification results, and encryption review request
results. This rule also changes certain recordkeeping requirements
associated with the elimination of paper documents. BIS is making these
changes to reduce mailing costs and to free up staff time currently
devoted to mailing these documents for use in other tasks.

DATES: This rule is effective May 5, 2010.

FOR FURTHER INFORMATION CONTACT: Thomas Andrukonis, Office of Exporter
Services, Bureau of Industry and Security, U.S. Department of Commerce
at<PHONE_NUMBER> or e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The Bureau of Industry and Security administers an export licensing
program pursuant to the Export Administration Regulations. As part of
this program, BIS issues various documents in response to applications
and notifications submitted to BIS by the public. Those documents
include export licenses, reexport licenses, notices that an export or
reexport license application has been denied, notices that an export or
reexport license application is being returned to the applicant without
action, responses to License Exception AGR notifications, notices of
the results of classification requests, and notices of the results of
encryption review requests. Collectively, these documents are referred
to in this preamble as ``license related documents.''
    Currently, BIS issues license related documents in two ways:
Electronically in BIS's Simplified Network Application Processing
Redesign system (SNAP-R) and on paper. Most license related documents
are issued in both electronic and paper form. However, a few such
documents are issued only on paper. On December 4, 2009, BIS issued a
proposed rule that would allow it to eliminate the paper version of the
license related documents that it currently issues both electronically
in SNAP-R and on paper (74 FR 63685, December 4, 2009). The last day of
the comment period for that proposed rule was February 2, 2010. BIS
received no public comments on that proposed rule. Accordingly, this
final rule adopts the

text of the proposed rule and makes one minor correction to pre-
existing text.
    The EAR require that export license applications, reexport license
applications, License Exception AGR notifications, encryption review
requests, and classification requests be submitted to BIS
electronically using SNAP-R, except in individual instances where BIS
authorizes a paper submission. The license related documents associated
with a SNAP-R submission are issued on line in SNAP-R where the
submitter may view, save, or print a copy. In addition, a paper version
of each of those documents is mailed to the submitter. There are two
situations in which BIS issues only a paper version of a license
related document: When BIS authorized a paper submission, and when BIS
must reissue the license related document because it reopened a matter
previously considered to be completed. BIS does not intend to stop
issuing paper license related documents in those two situations. BIS
also does not intend to change its practices regarding issuance of
Special Comprehensive Licenses or Special Iraq Reconstruction Licenses,
both of which are paper-based processes. BIS intends to discontinue
issuing paper documents in the situations where it currently issues
both paper and electronic versions of license related documents. BIS is
also making certain changes to the EAR recordkeeping requirements in
connection with this change.

Specific Changes Made by This Rule

Clarification That Electronic Notification in SNAP-R Is Considered To
Be, for Purposes of the EAR, Written Notification of the Results of a
License Exception AGR Request

    This rule revises Sec.  740.18(c)(5) to state that BIS will issue
confirmation in SNAP-R or via paper of the decision that no agency has
objected to a party's proposed use of License Exception AGR.
Previously, Sec.  740.18(c)(5) merely stated that BIS will issue a
written confirmation.

Removal of Requirement To Maintain a Log of Electronic Submissions

    This rule removes the requirement previously found in Sec.
748.7(c) of the EAR to maintain a log of electronic submissions. That
requirement was established in connection with BIS's initial electronic
application process, which was instituted in the 1980s. At that time,
electronic submissions were facilitated by a number of private sector
vendors and the logs may have been necessary for auditing purposes.
However, the information required to be kept in the log duplicates
information that parties are required to include in their SNAP-R
submissions or that is automatically recorded by SNAP-R, making the
information in the log redundant of information available to BIS in
SNAP-R. The rule this log maintenance requirement by removing paragraph
(c) of Sec.  748.7 and redesignating existing paragraph (d) as
paragraph (c).

Removal of Language Relating to ``Computer Generated'' Licenses, the
Department of Commerce Seal and Attachments to Licenses

    This rule revises Sec.  750.7(b) to state that BIS may issue export
and reexport licenses either electronically or on paper and that each
license will bear a license number. Previous language regarding
``computer generated'' licenses, the Department of Commerce seal and
attachments to licenses have been removed as has an explicit
requirement that exporters use the license number when communicating
with BIS about the license. The final rule language allows BIS to
exercise discretion in deciding whether to issue a license
electronically in SNAP-R or on paper. However, BIS expects that it will
issue nearly all licenses electronically. Unless some exceptional
circumstances exist, only licenses for which the applicant was
authorized to file the application on paper and licenses that BIS
cannot issue electronically (currently, only reopened licenses) will be
issued on paper. BIS is making this change to reduce the costs of
generating and mailing paper copies of licenses and to be able to
assign to other tasks the staff that otherwise would be needed to
handle paper licenses. Because no EAR provision previously addressed
issuance of the other license related documents with the specificity
with which Sec.  750.7(b) addresses licenses, only Sec.  750.7(b) must
be modified to implement this change.

Removal of Requirement To Attach a Replacement License to the Original

    This rule revises Sec.  750.7(h)(4) to remove a requirement that
the license holder attach a replacement license issued by BIS to the
original license that it replaces. That requirement dates to an era in
which electronic licenses did not exist and is impractical with
electronic licenses issued in SNAP-R. This rule retains the requirement
that the license holder keep both the original license and the
replacement license.

Removal of Requirement To Retain Copies of Documents Submitted to BIS
via the SNAP-R System

    This rule exempts parties who submit documents to BIS via BIS's
SNAP-R system from requirements to retain copies of documents so
submitted even though those documents are ``export control documents''
as defined in part 772 of the EAR. BIS believes the reliability of the
SNAP-R system provides adequate assurance that the documents received
by BIS were submitted and that all submitted documents are received by
BIS. This change would not preclude parties from storing copies of
these documents.

Addition of Certain Documents To Recordkeeping Requirements in Part 762

    This rule adds the following documents to the list of documents
required to be kept as set forth in Sec.  762.2(a)(10) required to be
kept: Notification from BIS that an application is being returned
without action; notification from BIS that an application is being
denied; notification from BIS of the results of a commodity
classification or encryption review request conducted by BIS. BIS
believes that requiring recipients of these documents to retain them is
needed to confirm receipt and to verify that the recipient received
notice of the terms of the document. This rule does not require parties
to retain requests for additional information concerning active matters
that they receive from BIS.

Application of Original Document Retention Requirement to Documents
Issued in SNAP-R

    Parties who receive documents issued by BIS in SNAP-R may store the
documents in two ways, and either would meet the requirement of Sec.
762.5 that original documents be retained. The two ways are: Storage of
complete documents issued by BIS in SNAP-R electronically in a format
readable by software possessed by the recipient party; or storage of a
complete printed paper copy of the document. Either way would provide
an accurate representation of the contents of the record and,
therefore, either should be treated as the equivalent of an original
document. This final rule also makes one minor correction to the
proposed rule text of Sec.  762.4.
    Section 762.4 consists of one paragraph. When stating that either
storage method described in this paragraph would be deemed to be an
original, the proposed rule text used the

phrase ``for purposes of this paragraph.'' The final rule replaces the
word ``paragraph'' in that phrase with the word ``section'' to be
consistent with standard Code of Federal Regulations nomenclature
practices.

Reasons for the Changes

    BIS has been expending funds and staff time to mail to certain
parties information that is entirely duplicative of information that
BIS sends to those same parties electronically. The changes in this
rule will help BIS to reduce its operating costs and free the staff
time that otherwise would be devoted to mailing paper documents to be
used for other purposes. BIS estimates that in recent years it has
spent approximately $25,000 annually in direct mailing costs
(envelopes, supplies and postage) to send out paper copies of licenses,
responses to classification requests, responses to encryption review
requests, and License Exception AGR notifications. BIS also has been
spending about 1.5 hours of staff time daily in connection with mailing
these documents.

Rulemaking Requirements

    1. This rule has been determined to be not significant for purposes
of E.O. 12866.
    2. Notwithstanding any other provision of law, no person is
required to respond to, nor is subject to a penalty for failure to
comply with, a collection of information, subject to the requirements
of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA),
unless that collection of information displays a currently valid Office
of Management and Budget (OMB) Control Number. This regulation contains
a collection previously approved by OMB under control number 0694-0096
which carries a burden hour estimate of 58 minutes to prepare and
submit form BIS-748. Miscellaneous and recordkeeping activities account
for 12 minutes per submission. BIS believes that the changes
implemented by this rule will not materially affect this burden. Send
comments regarding this burden estimate or any other aspect of this
collection of information, including suggestions for reducing the
burden, to Jasmeet Seehra, Office of Management and Budget (OMB), by e-
mail to<EMAIL_ADDRESS>or by fax to<PHONE_NUMBER>; and to the
Regulatory Policy Division, Bureau of Industry and Security, Department
of Commerce, Room 2705, 14th Street and Pennsylvania Ave., NW.,
Washington, DC 20230.
    3. This rule does not contain policies with Federalism implications
as that term is defined under E.O. 13132.
    4. The Chief Counsel for Regulations of the Department of Commerce
certified to the Chief Counsel for Advocacy of the Small Business
Administration at the proposed rule stage that this rule would not have
a significant economic impact on a substantial number of small
entities. The rationale for that certification was set forth in the
preamble to the proposed rule (74 FR 63686, December 4, 2009). BIS
received no comments on the certification. As a result, a final
regulatory impact analysis is not required and none has been prepared.

List of Subjects

15 CFR Parts 740, 748, and 750

    Administrative practice and procedure, Exports, Reporting and
recordkeeping requirements.

15 CFR Part 762

    Administrative practice and procedure, Business and industry,
Confidential business information, Exports, Reporting and recordkeeping
requirements.

0
Accordingly, the Export Administration Regulations (15 CFR parts 730-
774) are amended as follows:

PART 740--[AMENDED]

0
1. The authority citation for part 740 continues to read as follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 7201 et seq.; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp.,
p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice
of August 13, 2009, 74 FR 41325 (August 14, 2009).

0
2. Section 740.18 is amended by revising the sixth sentence of
paragraph (c)(5) to read as follows:

Sec.  740.18  Agricultural commodities (AGR).

* * * * *
    (c) * * *
    (5) * * * BIS will issue written confirmation electronically in
SNAP-R or via paper. * * *
* * * * *

PART 748--[AMENDED]

0
3. The authority citation for part 748 continues to read as follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66
FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 13, 2009, 74
FR 41325 (August 14, 2009).

Sec.  748.7  [Amended]

0
4. Section 748.7 is amended by removing paragraph (c) and redesignating
paragraph (d) as paragraph (c).

PART 750--[AMENDED]

0
5. The authority citation for part 750 continues to read as follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
Sec. 1503, Pub. L. 108-11, 117 Stat. 559; E.O. 13026, 61 FR 58767, 3
CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp.,
p. 783; Presidential Determination 2003-23 of May 7, 2003, 68 FR
26459, May 16, 2003; Notice of August 13, 2009, 74 FR 41325 (August
14, 2009).

Sec.  750.7  [Amended]

0
6. Section 750.7 is amended by removing the final sentence from
paragraph (a) and by revising paragraph (b) and paragraph (h)(4) to
read as follows:

Sec.  750.7  Issuance of licenses.

* * * * *
    (b) Issuance of a license. BIS may issue a license electronically
via its Simplified Network Application Processing (SNAP-R) system or
via paper or both electronically and via paper. Each license has a
license number that will be shown on the license.
* * * * *
    (h) * * *
    (4) Replacement license. If you have been issued a ``replacement
license'' (for changes to your original license not covered in
paragraph (c) of this section), you must retain both the original and
the replacement license.
* * * * *

PART 762--[AMENDED]

0
7. The authority citation for part 762 continues to read as follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August
13, 2009, 74 FR 41325 (August 14, 2009).

Sec.  762.2  [Amended]

0
8. Section 762.2 is amended by:
0
a. Revising paragraph (a)(1),
0
b. Removing the comma and the word ``and'' from the end of paragraph
(a)(9) and adding in their place, a semicolon,
0
c. Redesignating paragraph (a)(10) as paragraph (a)(11), and
0
d. Adding a new paragraph (a)(10) to read as follows:

Sec.  762.2  Records to be retained.

    (a) * * *
    (1) Export control documents as defined in part 772 of the EAR,
except

parties submitting documents electronically to BIS via the SNAP-R
system are not required to retain copies of documents so submitted;
* * * * *
    (10) Notification from BIS of an application being returned without
action; notification by BIS of an application being denied;
notification by BIS of the results of a commodity classification or
encryption review request conducted by BIS; and,
* * * * *

0
9. Section 762.4 is amended by adding a sentence at the end of the
section to read as follows:

Sec.  762.4  Original records required.

    * * * With respect to documents that BIS issues to a party in SNAP-
R, either an electronically stored copy in a format that makes the
document readable with software possessed by that party or a paper
print out of the complete document is deemed to be an original record
for purposes of this section.

    Dated: March 29, 2010.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
[FR Doc. 2010-7639 Filed 4-2-10; 8:45 am]
BILLING CODE 3510-33-P


shall include, with respect to such order flow sent by the customer to
the broker or dealer, the total number of shares sent to the broker or
dealer by the customer during the relevant period; the total number of
shares executed by the broker or dealer as principal for its own
account; the total number of orders exposed by the broker or dealer
through an actionable indication of interest; and the venue or venues
to which orders were exposed by the broker or dealer through an
actionable indication of interest, provided that, where applicable, a
broker or dealer must disclose that it exposed a customer's order
through an actionable indication of interest to other customers but
need not disclose the identity of such customers. Each section of such
report also shall include the following columns of information for each
venue to which the broker or dealer routed such orders for the
customer, in the aggregate:
    (i) Information on Order Routing. (A) Total shares routed;
    (B) Total shares routed marked immediate or cancel;
    (C) Total shares routed that were further routable; and
    (D) Average order size routed.
    (ii) Information on Order Execution. (A) Total shares executed;
    (B) Fill rate (shares executed divided by the shares routed);
    (C) Average fill size;
    (D) Average net execution fee or rebate (cents per 100 shares,
specified to four decimal places);
    (E) Total number of shares executed at the midpoint;
    (F) Percentage of shares executed at the midpoint;
    (G) Total number of shares executed that were priced on the side of
the spread more favorable to the order;
    (H) Percentage of total shares executed that were priced at the
side of the spread more favorable to the order;
    (I) Total number of shares executed that were priced on the side of
the spread less favorable to the order; and
    (J) Percentage of total shares executed that were priced on the
side of the spread less favorable to the order.
    (iii) Information on Orders that Provided Liquidity. (A) Total
number of shares executed of orders providing liquidity;
    (B) Percentage of shares executed of orders providing liquidity;
    (C) Average time between order entry and execution or cancellation,
for orders providing liquidity (in milliseconds); and

    (D) Average net execution rebate or fee for shares of orders
providing liquidity (cents per 100 shares, specified to four decimal
places).
    (iv) Information on Orders that Removed Liquidity. (A) Total number
of shares executed of orders removing liquidity;
    (B) Percentage of shares executed of orders removing liquidity; and
    (C) Average net execution fee or rebate for shares of orders
removing liquidity (cents per 100 shares, specified to four decimal
places).
    (4) Except as provided below, no broker or dealer shall be required
to provide reports pursuant to paragraph (b)(3) of this section if the
percentage of shares of not held orders in NMS stocks the broker or
dealer received from its customers over the prior six calendar months
was less than five percent of the total shares in NMS stocks the broker
or dealer received from its customers during that time (the ``five
percent threshold'' for purposes of this paragraph). A broker or dealer
that equals or exceeds this five percent threshold shall be required
(subject to paragraph (b)(5) of this section) to provide reports
pursuant to paragraph (b)(3) of this section for at least six calendar
months (``Compliance Period'') regardless of the percentage of shares
of not held orders in NMS stocks the broker or dealer receives from its
customers during the Compliance Period. The Compliance Period shall
begin the first calendar day of the next calendar month after the
broker or dealer equaled or exceeded the five percent threshold, unless
it is the first time the broker or dealer has equaled or exceeded the
five percent threshold, in which case the Compliance Period shall begin
the first calendar day four calendar months later. A broker or dealer
shall not be required to provide reports pursuant to paragraph (b)(3)
of this section for orders that the broker or dealer did not receive
during a Compliance Period. If, at any time after the end of a
Compliance Period, the percentage of shares of not held orders in NMS
stocks the broker or dealer received from its customers was less than
five percent of the total shares in NMS stocks the broker or dealer
received from its customers over the prior six calendar months, the
broker or dealer shall not be required to provide reports pursuant to
paragraph (b)(3) of this section, except for orders that the broker or
dealer received during the portion of a Compliance Period that remains
covered by paragraph (b)(3) of this section.
    (5) No broker or dealer shall be subject to the requirements of
paragraph (b)(3) of this section with respect to a customer that traded
on average each month for the prior six months less than $1,000,000 of
notional value of not held orders in NMS stocks through the broker or
dealer.
* * * * *

Sec.  242.611   [Amended]

0
12. In Sec.  242.611, paragraph (c) is amended by removing the text
``Sec.  242.600(b)(30)'' and adding in its place ``Sec.
242.600(b)(31)''.

Sec.  242.1000  [Amended]

0
13. In Sec.  242.1000 the definition of Plan processor is amended by
removing the text ``Sec.  242.600(b)(55)'' and adding in its place
``Sec.  242.600(b)(59)''.

    By the Commission.

    Dated: November 2, 2018.
Brent J. Fields,
Secretary.
[FR Doc. 2018-24423 Filed 11-16-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 67 (Friday, April 6, 2018)]
[Rules and Regulations]
[Pages 14757-14759]
[FR Doc No: 2018-06846]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-0AR-2017-0753; FRL-9976-02--Region 8]

Approval and Promulgation of Air Quality Implementation Plans;
State of Colorado; Revisions to the Transportation Conformity
Consultation Process

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve a State Implementation Plan (SIP) revision submitted
by Colorado on May 16, 2017. The May 16, 2017 SIP revision addresses
minor changes and typographical corrections to the transportation
conformity requirements of Colorado's Regulation Number 10 ``Criteria
for Analysis of Conformity.'' These actions are being taken under
section 110 of the Clean Air Act (CAA).

DATES: This rule is effective May 7, 2018.

ADDRESSES: The EPA has established a docket for this action under
Docket ID Number EPA-R08-OAR-2017-0753. All documents in the docket are
listed on the http://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
confidential business information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available through http://www.regulations.gov, or please
contact the person identified in the For Further Information Contact
section for additional availability information.

FOR FURTHER INFORMATION CONTACT: Tim Russ, Air Program, U.S.
Environmental Protection Agency, Region 8, Mailcode 8P-AR, 1595 Wynkoop
Street, Denver, Colorado 80202-1129,<PHONE_NUMBER>, or
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In this action, the EPA is approving minor revisions to Colorado's
Regulation Number 10 which is entitled ``Criteria for Analysis of
Conformity'' (hereafter, ``Regulation No. 10''). We note the factual
background for this action and our evaluation of the State's May 16,
2017 Regulation No. 10 SIP submittal are discussed in detail in our
February 1, 2018 proposed rule (83 FR 4614); therefore, they will not
be restated here.
    In summary, the purpose of Regulation No. 10 is to address the
transportation conformity SIP requirements of section 176(c) of the CAA
and 40 CFR 51.390(b). In addition, Regulation No. 10 also addresses the
following transportation conformity SIP element requirements: 40 CFR
93.105, which formalizes the consultation procedures; 40 CFR
93.122(a)(4)(ii), which addresses written commitments to control
measures that are not included in a Metropolitan Planning
Organization's (MPOs) transportation plan and transportation
improvement program that must be obtained prior to a conformity
determination; and 40 CFR 93.125(c), which addresses written
commitments to mitigation measures that must be obtained prior to a
project-level conformity determination.\1\ We note the most recent
prior SIP revisions to Regulation No. 10, that we approved, occurred on
March 4, 2014 (79 FR 12079).
---------------------------------------------------------------------------

    \1\ A conformity SIP includes a state's specific criteria and
procedures for certain aspects of the transportation conformity
process consistent with the federal conformity rule. A conformity
SIP does not contain motor vehicle emissions budgets, emissions
inventories, air quality demonstrations, or control measures. See
EPA's Guidance for Developing Transportation Conformity State
Implementation Plans (SIPs) for further background: https://nepis.epa.gov/Exe/ZyPDF.cgi/P1002W5B.PDF?Dockey=P1002W5B.PDF.
---------------------------------------------------------------------------

II. What was the State's process to submit a SIP revision to the EPA?

    Section 110(k) of the CAA addresses our actions on submissions of
revisions to a SIP. The CAA requires states to observe certain
procedural requirements in developing SIP revisions for submittal to
the EPA. Section 110(a)(2) of the CAA requires that each SIP revision
be adopted after reasonable notice and public hearing. This must occur
prior to the revision being submitted by a state.
    For the May 16, 2017 revisions to Regulation No. 10, the Colorado
Air Quality Control Commission (AQCC) held a public hearing for those
revisions on February 18, 2016. There were no public comments. The AQCC
adopted the revisions to Regulation No. 10 directly after the hearing.
This SIP revision became State effective on March 30, 2016, and was
submitted by Dr. Larry Wolk, Executive Director of the Colorado
Department of Public Health and Environment (CDPHE), and on behalf of
the Governor, to the EPA on May 16, 2017.
    We evaluated the State's May 16, 2017 submittal for Regulation No.
10 and determined that the State met the requirements for reasonable
notice and public hearing under section 110(a)(2) of the CAA. By
operation of law under section 110(k)(1)(B) of the CAA, the State's May
16, 2017 submittal was deemed complete by the EPA on November 25, 2017.

III. Response to Comments

    The EPA received one anonymous public comment on our February 1,
2018 proposed rule (83 FR 4614). After reviewing the comment, the EPA
has determined that the comment is outside the scope of our proposed
rule and fails to identify any material issue necessitating a response.
Accordingly, the EPA will not provide a specific response to the
comment. We note that the public comment received on this rulemaking
action is available for review by the public and may be viewed by
following the instructions for access to docket materials as outlined
in the ADDRESSES section of this preamble.

IV. Final Action

    For the reasons described in our February 1, 2018 proposed rule (83
FR 4614), and under CAA section 110(k)(3), the EPA is approving the
submitted revisions to Regulation No. 10, Section II, the definition of
Routine Conformity Determination. In addition, we are also approving
the typographic corrections to the Regulation No. 10 title, to Section
II and to the Section III subsections III.A.2, III.A.3, III.B.1.a,
III.C.1.b.(2), III.C.1.g and III.F.3.
    The EPA notes that revisions were also made to Colorado's
Regulation No. 10, section VI ``Statements of Basis, Specific Statutory
Authority, and Purpose''; however, the EPA is not taking any action on
the revisions to this section. The revisions to section VI are only
informational in nature for the State and do not require federal
approval into the SIP.

V. Consideration of Section 110(1) of the Clean Air Act

    Under section 110(l) of the CAA, the EPA cannot approve a SIP
revision if the revision would interfere with any applicable
requirements concerning attainment and Reasonable Further Progress
toward attainment of the National Ambient Air Quality Standards
(NAAQS), or any other applicable requirement of the CAA. The EPA has

determined that the portions of Regulation No. 10 that we are acting on
are consistent with the applicable requirements of the CAA.
Furthermore, these portions do not relax any previously approved SIP
provision; thus, they do not otherwise interfere with attainment and
maintenance of the NAAQS. In addition, section 110(l) of the CAA
requires that each revision to an implementation plan submitted by a
state shall be adopted by the state after reasonable notice and
opportunity for public hearing. On February 18, 2016, the AQCC held a
public hearing and the AQCC adopted the revisions to Regulation No. 10
directly after the hearing. This SIP revision became state effective on
March 30, 2016. Therefore, the CAA section 110(l) requirements are
satisfied.

VI. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the
revision to Regulation No. 10, Section II, the definition of Routine
Conformity Determination effective March 30, 2016. In addition, we are
also incorporating by reference the typographic corrections to the
Regulation No. 10 title, to Section II and to the Section III
subsections III.A.2, III.A.3, III.B.1.a, III.C.1.b.(2), III.C.1.g and
III.F.3 all effective March 30, 2016. The EPA has made, and will
continue to make, these materials generally available through
www.regulations.gov and at the EPA Region 8 Office (please contact the
person identified in the For Further Information Contact section of
this preamble for more information). Therefore, these materials have
been approved by the EPA for inclusion in the State implementation
plan, are fully federally enforceable under sections 110 and 113 of the
CAA as of the effective date of the final rulemaking of the EPA's
approval, and will be included in the next update to the SIP
compilation.\2\
---------------------------------------------------------------------------

    \2\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

VII. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices provided that they meet the criteria of the CAA. Accordingly,
this action merely approves state law as meeting federal requirements
and does not impose additional requirements beyond those imposed by
state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by June 5, 2018. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Volatile organic compounds.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: March 29, 2018.
Douglas H. Benevento,
Regional Administrator, Region 8.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart G--Colorado

0
2. Section 52.320(c) is amended:
0
a. By revising the centered heading for ``5 CCR 1001-12''; and
0
b. By revising, under the centered heading ``5 CCR 1001-12,'' the table
entries for ``II. Definitions'' and ``III. Interagency Consultation.''
    The revisions read as follows:

Sec.  52.320  Identification of plan.

* * * * *

    (c) * * *

----------------------------------------------------------------------------------------------------------------
                                     State       EPA effective   Final rule citation/
             Title              effective date       date                date                   Comments
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
             5 CCR 1001-12, Regulation Number 10, Criteria for Analysis of Transportation Conformity
----------------------------------------------------------------------------------------------------------------
II. Definitions.................................................................................................
III. Interagency Consultation...................................................................................

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-06846 Filed 4-5-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 121 (Thursday, June 23, 2011)]
[Notices]
[Page 36913]
[FR Doc No: 2011-15695]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR09-8-005]

Washington Gas Light Company; Notice of Motion for Extension of
Rate Case Filing Deadline

    Take notice that on June 15, 2011, Washington Gas Light Company
(Washington Gas) filed a request for an extension consistent with the
Commission's revised policy of periodic review from a triennial to a
five year period. The Commission in Order No. 735 modified its policy
concerning periodic reviews of rates charges by section 311 and Hinshaw
pipelines to extend the cycle for such reviews from three to five
years.\1\ Therefore, Washington Gas requests that the date for its next
rate filing be extended to December 9, 2013, which is five years from
the date of Washington Gas' most recent rate filing with this
Commission.
---------------------------------------------------------------------------

    \1\ Contract Reporting Requirements of Intrastate Natural Gas
Companies, Order No. 735, 131 FERC ] 61,150 (May 20, 2010).
---------------------------------------------------------------------------

    Any person desiring to participate in this rate proceeding must
file a motion to intervene or to protest this filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 7 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on Monday, June 27, 2011.

    Dated: June 16, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-15695 Filed 6-22-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 51 (Wednesday, March 16, 2022)]
[Notices]
[Pages 14891-14893]
[FR Doc No: 2022-05517]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1593]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Accessories

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on medical device accessory
requests.

DATES: Submit either electronic or written comments on the collection
of information by May 16, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 16, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 16, 2022. 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.

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-2016-N-1593 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device Accessories.''
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,<PHONE_NUMBER>.
     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
Dockets Management Staff. 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.govinfo.gov/content/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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Medical Device Accessories

OMB Control Number 0910-0823--Extension

    FDA's guidance document entitled ``Medical Device Accessories--
Describing Accessories and Classification Pathways'' (the Accessories
guidance) \1\ is intended to provide guidance to industry and FDA staff
about the regulation of accessories to medical devices, to describe
FDA's policy concerning the classification of accessories, and to
discuss the application of this policy to devices that are commonly
used as accessories to other medical devices. In addition, the guidance
explains what devices FDA generally considers an ``accessory'' and
describes the processes under section 513(f)(6) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360c(f)(6)) to allow requests for
risk- and regulatory control-based classification of accessories.
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    \1\ The guidance document is available on FDA's website (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-accessories-describing-accessories-and-classification-pathways).
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    The FDA Reauthorization Act of 2017 (FDARA) changed how FDA
regulates medical device accessories. Specifically, section 707 of
FDARA added section 513(f)(6) to the statute and requires that FDA,
upon request, classify existing and new accessories notwithstanding the
classification of any other device with which such accessory is
intended to be used. This means that the classification of an accessory
may not be the same as its parent device, depending on the risks of the
accessory when used as intended and the level of regulatory controls
necessary for reasonable assurance of safety and effectiveness of the
accessory. Until an accessory is distinctly classified, its existing
classification will continue to apply. This provision does not preclude
a manufacturer from submitting a De Novo request for an accessory.
    Depending on an accessory's regulatory history, there are different
submission types, tracking mechanisms, and deadlines:
    (1) Existing accessory types are those that have been identified in
a classification regulation or granted marketing authorization as part
of a 510(k), pre-market application (PMA), or De Novo request (approved
under OMB control numbers 0910-0120, 0910-0231, and 0910-0844,
respectively). Manufacturers with marketing authorization for an
existing accessory may request appropriate classification through a new
stand-alone premarket submission (Existing Accessory Request). Upon
request, FDA is required to meet with a manufacturer or importer to
discuss the appropriate classification of an existing accessory prior
to submitting a written request. Existing Accessory Requests will be
initially tracked as ``Q-submissions'' (approved under OMB control
number 0910-0756). FDA has a statutory deadline of 85 calendar days to
respond to an Existing Accessory Request.
    (2) New accessory types are those that have not been granted
marketing authorization as part of a 510(k), PMA, or De Novo request.
Manufacturers may include new accessories into a 510(k) or PMA with the
parent device (New Accessory Request). New Accessory Requests will have
the same deadline as the 510(k) or PMA. Therefore, new accessory types
should follow the applicable Medical Device User Fee Amendments of 2017
deadline for the parent submission. The decision for New Accessory
Requests will be separate from the decision for the marketing
application.
    For both Existing and New Accessory Requests, manufacturers must
request proper classification of their accessory in the submission and
include draft special controls, if requesting classification into class
II. The processes that we use to classify an accessory will be like
those used for De Novo requests. If FDA grants the Accessory Request,
FDA must issue an order establishing a new classification regulation
for the accessory type. If FDA denies the Accessory Request, FDA must
issue a

letter with a detailed description and justification for our
determination.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
 Activity; guidance for industry     Number of     responses per   Total annual     burden per      Total hours
          (GFI) section             respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Existing Accessory Request; GFI               10               1              10              40             400
 VI.A...........................
New Accessory Request...........               5               1               5              40             200
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             600
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on an evaluation of the information collection, we have
reduced the estimated number of existing requests from 15 to 10, and we
have reduced the estimated number of new requests from 10 to 5. This
adjustment results in an overall reduction to the information
collection by 10 responses and 400 hours annually. We believe these
adjustments more accurately reflect the current number of requests
associated with medical device accessory classifications.

    Dated: March 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05517 Filed 3-15-22; 8:45 am]
BILLING CODE 4164-01-P