[Federal Register Volume 82, Number 243 (Wednesday, December 20, 2017)]
[Proposed Rules]
[Pages 60348-60350]
[FR Doc No: 2017-27432]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2017-0140; FRL-9972-31-Region 9]

Approval of California Air Plan Revisions, San Diego County Air
Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the San Diego County Air Pollution Control
District (SDCAPCD) portion of the California State Implementation Plan
(SIP). These revisions concern volatile organic compound (VOC)
emissions from polyester resin operations. We are proposing to approve
a local rule to regulate these emission sources under the Clean Air Act
(CAA or ``the Act''), as well as a rule rescission. We are taking
comments on this proposal and plan to follow with a final action.

DATES: Any comments must arrive by January 19, 2018.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2017-0140 at http://www.regulations.gov, or via email to Doris Lo,
Rulemaking Office Chief at [email protected]. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be removed or edited from
Regulations.gov. For either manner of submission, the EPA may publish
any comment received to its public docket. Do not submit electronically
any information you consider to be Confidential Business Information
(CBI) or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e. on the web, cloud, or other
file sharing system). For additional submission methods, please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section.
For the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Arnold Lazarus, EPA Region IX, (415)
972-3024, [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rule and rule
rescission?
II. The EPA's Evaluation and Action
    A. How is the EPA evaluating the rule?
    B. Do the rule and rule rescission meet the evaluation criteria?
    C. The EPA's Recommendations to Further Improve the Rule
    D. Public Comment and Proposed Action
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules addressed by this action with the date that
they were adopted and repealed by the local air agency and submitted by
the California Air Resources Board (CARB).

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
                                                                     Adopted/        Repealed/
         Local agency              Rule No.        Rule title         amended        rescinded       Submitted
----------------------------------------------------------------------------------------------------------------
SDCAPCD.......................           67.12  Polyester Resin        5/15/1996       5/11/2016         8/22/16
                                                 Operations.
SDCAPCD.......................         67.12.1  Polyester Resin        5/11/2016  ..............         8/22/16
                                                 Operations.
----------------------------------------------------------------------------------------------------------------

On September 27, 2016, the EPA determined that the submittals for
SDCAPCD Rules 67.12 and 67.12.1 met the completeness criteria in 40 CFR
part 51 Appendix V, which must be met before formal review by the EPA.

B. Are there other versions of these rules?

    There are no previous versions of Rule 67.12.1 in the SIP. We
approved Rule 67.12 on March 27, 1997 (62 FR 14639).

C. What is the purpose of the submitted rule and rule rescission?

    VOCs help produce ground-level ozone, smog and particulate matter,
which harm human health and the environment. Section 110(a) of the CAA
requires states to submit regulations that control VOC emissions. Rule
67.12.1, and the rescinded Rule 67.12, control VOCs emitted from
polyester resin

operations. The EPA's technical support document (TSD) has more
information about these rules.

II. The EPA's Evaluation and Action

A. How is the EPA evaluating the rule?

    SIP rules must be enforceable (see CAA section 110(a)(2)), must not
interfere with applicable requirements concerning attainment and
reasonable further progress or other CAA requirements (see CAA section
110(l)), and must not modify certain SIP control requirements in
nonattainment areas without ensuring equivalent or greater emissions
reductions (see CAA section 193).
    Generally, SIP rules must require Reasonably Available Control
Technology (RACT) for each category of sources covered by a Control
Techniques Guidelines (CTG) document as well as each major source of
VOCs in ozone nonattainment areas classified as Moderate or above (see
CAA section 182(b)(2)). The SDCAPCD regulates an ozone nonattainment
area classified as ``Moderate'' for the 2008 8-hour ozone National
Ambient Air Quality Standard (NAAQS) (40 CFR 81.305). Rule 67.12.1
regulates activities covered by the CTG titled ``Control Techniques
Guidelines for Fiberglass Boat Manufacturing Materials,'' EPA-453/R-08-
004, September 2008. However, none of the sources regulated by Rule
67.12.1 meet the applicability threshold for the Fiberglass Boat
Manufacturing CTG.
    Guidance and policy documents that we use to evaluate
enforceability, revision/relaxation and rule stringency requirements
for the applicable criteria pollutants include the following:
    1. ``State Implementation Plans; General Preamble for the
Implementation of Title I of the Clean Air Act Amendments of 1990'' (57
FR 13498, April 16, 1992 and 57 FR 18070, April 28, 1992).
    2. ``Issues Relating to VOC Regulation Cutpoints, Deficiencies, and
Deviations'' (``the Bluebook,'' U.S. EPA, May 25, 1988; revised January
11, 1990).
    3. ``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies'' (``the Little Bluebook'', EPA Region 9, August 21,
2001).
    4. ``Control Techniques Guidelines for Fiberglass Boat
Manufacturing Materials,'' EPA-453/R-08-004, September 2008.

B. Do the rule and rule rescission meet the evaluation criteria?

    This rule and rule rescission are consistent with the CAA
requirements and relevant guidance regarding enforceability, RACT, and
SIP relaxations. Based on information provided by the SDCAPCD, the
District does not appear to have facilities that are subject to the
fiberglass boat manufacturing CTG and therefore the District's RACT
analysis for Rule 67.12.1 is not required to address the presumptive
RACT limits included in the CTG.\1\ The TSD has more information on our
evaluation.
---------------------------------------------------------------------------

    \1\ Email dated July 12, 2017, from Angela Ortega (SDCAPCD) to
Arnold Lazarus (USEPA), RE: ``RE: Response to EPA regarding Rule
67.12.1 06_30_17 revised.docx'' with attachment. See Table 1.
``Summary of Total Emission Reduction.''
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C. The EPA's Recommendations to Further Improve the Rule

    The TSD describes additional rule revisions that we recommend for
the next time the local agency modifies the rule.
    We recommend the SDCAPCD consider adopting a negative declaration
for the fiberglass boat manufacturing operations CTG since the
District's data indicate it does not have facilities meeting the CTG's
applicability threshold of 15 lb/day or 2.7 tpy.

D. Public Comment and Proposed Action

    As authorized in section 110(k)(3) of the Act, the EPA proposes to
fully approve the submitted rule and rule rescission because they
fulfill all relevant requirements. We will accept comments from the
public on this proposal until January 19, 2018. If we take final action
to approve the submitted rule and rule rescission, our final action
will incorporate the rule and rule rescission into the federally
enforceable SIP.

III. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the SDCAPCD rule described in Table 1 of this preamble. The
EPA has made, and will continue to make, these materials available
through www.regulations.gov and at the EPA Region IX Office (please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section of this preamble for more information).

IV. 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 Clean Air Act.
Accordingly, this proposed action merely proposes to approve state law
as meeting federal requirements and does not impose additional
requirements beyond those imposed by state law. For that reason, this
proposed 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 disproportionate human health or environmental effects with
practical, appropriate, 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 the 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).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Volatile organic compounds,
Particulate matter.

    Dated: December 5, 2017.
Alexis Strauss,
Acting Regional Administrator, Region IX.
[FR Doc. 2017-27432 Filed 12-19-17; 8:45 am]
 BILLING CODE 6560-50-P


Record for the Final Metal Product and Machinery Rule Recreational and Non Use Benefits, Weighted ( Final Option: Traditional Extrapolation)

Low Mid High Fishing $ 287,220.40 $ 537,197.33 $ 923,987.70 Boating $ 114,110.68 $ 202,691.28 $ 316,077.80 Viewing $ 185,172.06 $ 259,948.96 $ 334,314.70 Recreational $ 586,503.15 $ 999,837.57 $ 1,574,380.19 Non Use $ 293,251.57 $ 499,918.78 $ 787,190.10 Total $ 879,754.72 $ 1,499,756.35 $ 2,361,570.29 Activity Annual Benefits ( 2001$)

February 14, 2003 Page 1 of 1 exlrec. xls  Recreational


processes. For systems based on photographic, photostatic, or miniature
photographic processes, the records must be maintained according to an
index of all records in the system following the same criteria that
would have been used to organize the records had they been maintained
in original form.

Sec.  786.3  Destruction or disposal of records.

    If BIS or any other authorized U.S. government agency makes a
formal or informal request for a certain record or records, such record
or records may not be destroyed or disposed of without the written
authorization of the requesting entity.

PARTS 787-799--[RESERVED]

    Dated: July 17, 2008.
Christopher R. Wall,
Assistant Secretary for Export Administration.
 [FR Doc. E8-16815 Filed 7-24-08; 8:45 am]

BILLING CODE 3510-33-P


[Federal Register Volume 85, Number 47 (Tuesday, March 10, 2020)]
[Rules and Regulations]
[Page 13747]
[FR Doc No: 2020-04786]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2020-0136]

Special Local Regulation; San Diego Crew Classic, San Diego, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the San Diego Crew Classic
special local regulation on the waters of Mission Bay, California on
April 4, 2020 and April 5, 2020. These special local regulations are
necessary to provide for the safety of the participants, crew,
spectators, sponsor vessels, and general users of the waterway. During
the enforcement period, persons and vessels are prohibited from
anchoring, blocking, loitering, or impeding within this regulated area
unless authorized by the Captain of the Port, or his designated
representative.

DATES: The regulations in 33 CFR 100.1101 will be enforced for the San
Diego Crew Classic regulated area listed in item 3 in Table 1 to Sec.
100.1101 from 6 a.m. to 7 p.m. on April 4, 2020 and April 5, 2020.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email Lieutenant Briana Biagas,
Waterways Management, U.S. Coast Guard Sector San Diego, CA; telephone
(619) 278-7656, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the special
local regulations in 33 CFR 100.1101 Table 1, Item 3 of that section
for the San Diego Crew Classic in Mission Bay, CA from 6 a.m. to 7 p.m.
on April 4, 2020, and from 6 a.m. to 7 p.m. on April 5, 2020. This
action is being taken to provide for the safety of life on navigable
waterways during the 2-day rowing race event. Our regulation for marine
events within the Eleventh Coast Guard District, Sec.  100.1101,
specifies the location of the regulated area for the San Diego Crew
Classic which encompasses the waters of Mission Bay to include South
Pacific Passage, Fiesta Bay, and the waters around Vacation Isle. Under
the provisions of Sec.  100.1101, persons and vessels are prohibited
from anchoring, blocking, loitering, or impeding within this regulated
area unless authorized by the Captain of the Port, or his designated
representative. The Coast Guard may be assisted by other Federal,
State, or local law enforcement agencies in enforcing this regulation.
    In addition to this notice of enforcement in the Federal Register,
the Coast Guard will provide the maritime community with advance
notification of this enforcement period via the Local Notice to
Mariners, Broadcast Notice to Mariners, and local advertising by the
event sponsor.
    If the Captain of the Port Sector San Diego or his designated
representative determines that the regulated area need not be enforced
for the full duration stated on this document, he or she may use a
Broadcast Notice to Mariners or other communications coordinated with
the event sponsor to grant general permission to enter the regulated
area.

    Dated: March 4, 2020.
T.J. Barelli,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. 2020-04786 Filed 3-9-20; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 68 (Tuesday, April 11, 2017)]
[Notices]
[Pages 17439-17440]
[FR Doc No: 2017-07215]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2017-0240]

National Offshore Safety Advisory Committee

AGENCY: Coast Guard, Department of Homeland Security.

ACTION: Notice of Federal Advisory Committee meeting.

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SUMMARY: The National Offshore Safety Advisory Committee and its
Subcommittee will hold meetings in New Orleans, Louisiana to discuss
the safety of operations and other matters affecting the offshore oil
and gas industry. These meetings are open to the public.

DATES: The Safety Management Systems on Vessels Engaging in Well
Intervention Activities Subcommittee of the National Offshore Safety
Advisory Committee will meet on Tuesday, May 16, 2017 from 1 p.m. to 3
p.m. and the full Committee will meet on Wednesday, May 17, 2017, from
8 a.m. to 5:30 p.m. (All times are Central Daylight Time). These
meetings may end early if the Committee has completed its business, or
they may be extended based on the number of public comments.

ADDRESSES: The meetings will be held at the Omni Riverfront Hotel, 701
Convention Center Boulevard, New Orleans, Louisiana 70130. Omni
Riverfront Hotel.
    For information on facilities or services for individuals with
disabilities, or to request special assistance at the meetings, contact
the individuals listed in the FOR FURTHER INFORMATION CONTACT section
as soon as possible.
    Instructions: You are free to submit comments at any time,
including orally at the meetings, but if you want committee members to
review your comment before the meetings, please submit your comments no
later than April 24, 2017. We are particularly interested in comments
on the issues in the ``Agenda'' section below. You must include
``Department of Homeland Security'' and the docket number USCG-2017-
0240. Written comments may also be submitted using the Federal
eRulemaking Portal at http://www.regulations.gov. If you encounter
technical difficulties with comment submission, contact the individuals
listed in the FOR FURTHER INFORMATION CONTACT section below. 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 the Federal Docket Management
System in the March 24, 2005, issue of the Federal Register (70 FR
15086).
    Docket Search: For access to the docket or to read documents or
comments related to this notice, go to http://www.regulations.gov,
insert USCG-2017-0240 in the Search box, press Enter, and then click on
the item you wish to view.
    A public oral comment period will be held during the meeting on May
17, 2017, and speakers are requested to limit their comments to 3
minutes. Contact one of the individuals listed below to register as a
speaker.

FOR FURTHER INFORMATION CONTACT: Commander Jose Perez, Designated
Federal Officer of the National Offshore Safety Advisory Committee,
Commandant (CG-OES-2), United States Coast Guard, 2703 Martin Luther
King Jr. Avenue Southeast, Stop 7509, Washington, DC 20593-7509;
telephone<PHONE_NUMBER>, fax<PHONE_NUMBER> or email
<EMAIL_ADDRESS>or Mr. Patrick Clark, telephone<PHONE_NUMBER>,
fax<PHONE_NUMBER> or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Notice of this meeting is in compliance with
the Federal Advisory Committee Act, Title 5 United States Code
Appendix. The National Offshore Safety Advisory Committee provides
advice and recommendations to the Department of Homeland Security on
matters and actions concerning activities directly involved with or in
support of the exploration of offshore mineral and energy resources
insofar as they relate to matters within United States Coast Guard
jurisdiction.
    A copy of all meeting documentation will be available at https://homeport.uscg.mil/nosac no later than April 16, 2017. Alternatively,
you may contact Mr. Patrick Clark as noted in the FOR FURTHER
INFORMATION CONTACT section above.

Agenda

Day 1

    The National Offshore Safety Advisory Committee's Subcommittee on
``Safety Management Systems on Vessels Engaging in Well Intervention
Activities'' will meet on May 16, 2017 from 1 p.m. to 3 p.m. to review,
discuss, and formulate recommendations.

Day 2

    The National Offshore Safety Advisory full Committee will hold a
public meeting on May 17, 2017 from 8 a.m. to 5:30 p.m. (Central
Daylight Time) to review and discuss the progress of, and any reports
and recommendations received from, the above listed Subcommittee from
their deliberations on May 16, 2017. The Committee will then use this
information and consider public comments in formulating recommendations
to the United States Coast Guard. Public comments or

questions will be taken at the discretion of the Designated Federal
Officer during the discussion and recommendation portions of the
meeting and during the public comment period, see Agenda item (8).
    A complete agenda for May 17, 2017 Committee meeting is as follows:
    (1) Welcoming remarks.
    (2) General Administration and accept minutes from February 21,
2017 National Offshore Safety Advisory Committee public teleconference
meeting.
    (3) Installation of new members.
    (4) Installation of new Committee Chair.
    (5) Current Business--Presentation and discussion of progress from
the Subcommittee on Safety Management Systems on Vessels Engaging in
Well Intervention Activities.
    (6) New Business.
    (7) Presentations on the following matters:
    (a) ``The Internet of Things'' and how digital engineering can
transform the safety and operability of equipment used by the oil and
gas industry;
    (b) United States Coast Guard Cyber Security Initiatives update;
    (c) Update from the Bureau of Safety and Environmental Enforcement;
    (d) Eighth Coast Guard District Officer in Charge Marine Inspection
Outer Continental Shelf Inspection Program Updates.
    (8) Public comment period.

Minutes

    Meeting minutes from this public meeting will be available for
public view and copying within 90 days following the close of the
meeting at the https://homeport.uscg.mil/nosac Web site.

    Dated: April 5, 2017.
J.G. Lantz,
Director of Commercial Regulations and Standards.
[FR Doc. 2017-07215 Filed 4-10-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 55 (Friday, March 21, 2014)]
[Proposed Rules]
[Pages 15715-15718]
[FR Doc No: 2014-06272]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2014-0089]
RIN 1625-AA08

Special Local Regulation; Stuart Sailfish Regatta, Indian River;
Stuart, FL

AGENCY: Coast Guard, DHS.

ACTION: Notice of Proposed Rulemaking.

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SUMMARY: The Coast Guard proposes to establish a special local
regulation on the Indian River located northeast of Ernest F. Lyons
Bridge and south of Joes Cove, in Stuart, Florida during the Stuart
Sailfish Regatta, a series of high-speed boat races. The Stuart
Sailfish Regatta will take place from May 16 through May 18, 2014.
Approximately 120 high-speed power boats will be participating in the
event. It is anticipated that at least 100 spectator vessels will be
present during the event. This special local regulation is necessary
for the safety of race participants, participant vessels, spectators
and the general public during the event. The special local regulation
will establish the following three areas: (1) A race area, where all
persons and vessels, except those participating in the high-speed boat
races, are prohibited from entering, transiting through, anchoring in,
or remaining within; (2) a buffer zone around the race area, where all
persons and vessels, except those persons and vessels enforcing the
buffer zone, or authorized participants or vessels transiting to the
race area, are prohibited from entering, transiting through, anchoring
in, or remaining within; and (3) a spectator area, where all persons
are prohibited from entering the water or swimming in the designated
area.

DATES: Comments and related material must be received by the Coast
Guard on or before April 21, 2014. Requests for public meetings must be
received by the Coast Guard on or before April 21, 2014.

ADDRESSES: You may submit comments identified by docket number using
any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: 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. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for further instructions
on submitting comments. To avoid duplication, please use only one of
these three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer John K. Jennings, Sector Miami Prevention
Department, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Cheryl Collins, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation. You may submit your comments and material online at
http://www.regulations.gov, or by fax, mail, or hand delivery, but
please use only one of these means. If you submit a comment online, it
will be considered received by the Coast Guard when you successfully
transmit the comment. If you fax, hand deliver, or mail your comment,
it will be considered as having been received by the Coast Guard when
it is received at the Docket Management Facility. We recommend that you
include your name and a mailing address, an email address, or a
telephone number in the body of your document so that we can contact
you if we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number (USCG-2014-0089) in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the

docket number (USCG-2014-0089) in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one, using one of the methods specified under ADDRESSES.
Please explain why you believe a public meeting would be beneficial. If
we determine that one would aid this rulemaking, we will hold one at a
time and place announced by a later notice in the Federal Register.

B. Regulatory History and Information

    Previously, a temporary special local regulation regarding this
marine event was published in the Code of Federal Regulations at 33 CFR
100 (see 78 FR 18475). No final rule has been published in regards to
this marine event. The proposed special local regulation is not new in
its entirety, but merely reflects updates to certain details of the
event.

C. Basis and Purpose

    The legal basis for the rule is the Coast Guard's authority to
establish special local regulations: 33 U.S.C. 1233.
    The purpose of the rule is to provide for the safety of life on the
navigable waters of the United States during the Stuart Sailfish
Regatta.

D. Discussion of Proposed Rule

    From May 16 through May 18, 2014, Stuart Sailfish Regatta, Inc.
will be hosting the Stuart Sailfish Regatta, a series of high-speed
boat races. The races will be held on the Indian River located
northeast of Ernest F. Lyons Bridge and south of Joes Cove, in Stuart,
Florida. Approximately 120 high-speed power boats will be participating
in the event. It is anticipated that at least 100 spectator vessels
will be present during the event.
    The proposed rule will establish a special local regulation that
will encompass certain navigable waters of the Indian River located
northeast of Ernest F. Lyons Bridge and south of Joes Cove, in Stuart,
Florida. The special local regulation will be enforced daily from 8
a.m. until 5 p.m. from May 16 through May 18, 2014. The special local
regulation will consist of the following three areas: (1) A race area,
where all persons and vessels, except those participating in the high-
speed boat races, are prohibited from entering, transiting through,
anchoring in, or remaining within; (2) a buffer zone around the race
area, where all persons and vessels, except those persons and vessels
enforcing the buffer zone, or authorized participants or vessels
transiting to the race area, are prohibited from entering, transiting
through, anchoring in, or remaining within; and (3) a spectator area,
where all persons are prohibited from entering the water or swimming in
the designated area.
    Persons and vessels may request authorization to enter the special
local regulated area by contacting the Captain of the Port Miami by
telephone at<PHONE_NUMBER>, or a designated representative via VHF radio
on channel 16, to request authorization. If authorization to enter,
transit through, anchor in, or remain within the special local
regulated area is granted by the Captain of the Port Miami or a
designated representative, all persons and vessels receiving such
authorization must comply with the instructions of the Captain of the
Port Miami or a designated representative.

E. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes or executive orders.

1. Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. The economic impact of
this proposed rule is not significant for the following reasons: (1)
This special local regulation will be enforced for nine hours a day for
three days; (2) non-participant persons and vessels may enter, transit
through, anchor in, or remain within the regulated area during their
respective enforcement periods if authorized by the Captain of the Port
Miami or a designated representative; (3) non-participant persons and
vessels not able to enter, transit through, anchor in, or remain within
the regulated areas without authorization from the Captain of the Port
Miami or a designated representative may operate in the surrounding
areas during the respective enforcement periods; and (4) the Coast
Guard will provide advance notification of the special local regulation
to the local maritime community by Local Notice to Mariners and
Broadcast Notice to Mariners.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule will not have a significant economic impact on a
substantial number of small entities. This rule may affect the
following entities, some of which may be small entities: The owners or
operators of vessels intending to enter, transit through, anchor in, or
remain within any of the regulated area during the respective
enforcement periods. For the reasons discussed in the Regulatory
Planning and Review section above, this rule will not have a
significant economic impact on a substantial number of small entities.
If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for

compliance, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section above. The Coast Guard will not retaliate
against small entities that question or complain about this proposed
rule or any policy or action of the Coast Guard.

4. Collection of Information

    This proposed rule will not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520.).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
determined that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

8. Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

9. Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

10. Protection of Children From Environmental Health Risks

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

11. Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). The
Coast Guard previously completed an environmental assessment for this
event and regulation in 2012, as well as conducted a supplemental
environmental assessment in 2013. The event and regulation for the 2012
and 2013 occurrences are similar in all aspects to this year's event
and regulation; therefore the same environmental assessment and
supplemental environmental assessment are being referenced for this
year's event and regulation. The environmental assessment is available
in the docket folder for USCG-2012-0150 at www.regulations.gov. This
proposed rule involves establishing a special local regulation that
will be enforced from 8 a.m. until 5 p.m. daily May 16 through 18 2014.
This rule is categorically excluded from further review under paragraph
34(h) of Figure 2-1 of the Commandant Instruction. We seek any comments
or information that may lead to the discovery of a significant
environmental impact from this proposed rule.

List of Subjects in 33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority:  33 U.S.C. 1233.

0
2. Add a temporary 33 CFR 100.35T07-0089 to read as follows:

Sec.  100.35T07-0089  Special Local Regulation; Stuart Sailfish
Regatta, Indian River, Stuart, FL.

    (a) Regulated Areas. The following regulated area is established as
a special local regulation. All coordinates are North American Datum
1983.
    (1) Race Area. All waters of Indian River located northeast of
Ernest Lyons Bridge and south of Joes Cove that are encompassed within
the following points: Starting at Point 1 in position 27[deg]12'46'' N,
80[deg]11'09'' W; thence southeast to Point 2 in position
27[deg]12'41'' N, 80[deg]11'08'' W; thence southwest to Point 3 in
position 27[deg]12'37'' N, 80[deg]11'11'' W; thence southwest to Point
4 in position 27[deg]12'33'' N, 80[deg]11'18'' W; thence southwest to
Point 5 in position 27[deg]12'31'' N, 80[deg]11'23'' W; thence west to
Point 6 in position 27[deg]12'31'' N, 80[deg]11'27'' W; thence
northwest to Point 7 in position 27[deg]12'33'' N, 80[deg]11'31'' W;
thence northwest to Point 8 in position 27[deg]12'38'' N,
80[deg]11'32'' W; thence northeast to Point 9 in position
27[deg]12'42'' N, 80[deg]11'30'' W; thence northeast to Point 10 in
position 27[deg]12'46'' N, 80[deg]11'26'' W; thence northeast to Point
11 in position 27[deg]12'48'' N, 80[deg]11'20'' W; thence east to Point
12 in position 27[deg]12'48'' N, 80[deg]11'15'' W; thence southeast
back to origin. All persons and vessels, except those persons and
vessels participating in the high-speed boat races, are prohibited from
entering, transiting through, anchoring in, or remaining within the
race area.
    (2) Buffer Zone. All waters of Indian River located northeast of
Ernest Lyons

Bridge and south of Joes Cove that are encompassed within the following
points: Starting at Point 1 in position 27[deg]12'47'' N,
80[deg]11'43'' W; thence southeast to Point 2 in position
27[deg]12'22'' N, 80[deg]11'28'' W; thence northeast to Point 3 in
position 27[deg]12'35'' N, 80[deg]11'00'' W; thence northwest to Point
4 in position 27[deg]12'47'' N, 80[deg]11'04'' W; thence northeast to
Point 5 in position 27[deg]13'05'' N, 80[deg]11'01'' W; thence
southeast back to origin. All persons and vessels, except those persons
and vessels enforcing the buffer zone, or authorized participants or
vessels transiting to the race area, are prohibited from entering,
transiting through, anchoring in, or remaining within the buffer zone.
    (3) Spectator Area. All waters of Indian River located northeast of
Ernest Lyons Bridge and south of Joes Cove that are encompassed within
the following points: Starting at Point 1 in position 27[deg]12'48'' N,
80[deg]11'43'' W; thence northeast to Point 2 in position
27[deg]12'55'' N, 80[deg]11'26'' W; thence southeast to Point 3 in
position 27[deg]12'52'' N, 80[deg]11'24'' W; thence southwest to Point
4 in position 27[deg]12'40'' N, 80[deg]11'39'' W; thence northwest back
to origin. All persons are prohibited from entering the water or
swimming in the spectator area.
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, state, and local officers designated by or assisting the
Captain of the Port Miami in the enforcement of the regulated areas.
    (c) Regulations.
    (1) Non-participant persons and vessels are prohibited from
entering, transiting through, anchoring in, or remaining within the
race area and/or buffer zone of the special local regulated area unless
authorized by Captain of the Port Miami or a designated representative.
All persons are prohibited from entering the water or swimming in the
spectator area. Non-participant persons and vessels may request
authorization to enter, transit through, anchor in, or remain within
the race area and/or buffer zone of the special local regulated area by
contacting the Captain of the Port Miami by telephone at<PHONE_NUMBER>,
or a designated representative via VHF radio on channel 16. If
authorization is granted by the Captain of the Port Miami or a
designated representative, all persons and vessels receiving such
authorization must comply with the instructions of the Captain of the
Port Miami or a designated representative.
    (2) The Coast Guard will provide notice of the special local
regulation by Local Notice to Mariners, Broadcast Notice to Mariners,
and on-scene designated representatives.
    (d) Effective Date. This rule will be enforced from 8 a.m. until 5
p.m. daily from May 16, 2014 through May 18, 2014.

    Dated: March 5, 2014.
A.J. Gould,
Captain, U.S. Coast Guard, Captain of the Port Miami.
[FR Doc. 2014-06272 Filed 3-20-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: December 5, 2008 (Volume 73, Number 235)]
[Rules and Regulations]
[Page 73999-74003]
[DOCID:fr05de08-3]

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

DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 744

[Docket No.<PHONE_NUMBER>-81395-01]
RIN 0694-AE48

Addition of Certain Persons to the Entity List: Persons Acting
Contrary to the National Security or Foreign Policy Interests of the
United States

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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

SUMMARY: This rule amends the Export Administration Regulations (EAR)
by adding additional persons to the Entity List (Supplement No. 4 to
Part 744) on the basis of Section 744.11 of the EAR. This rule is the
second rule to add persons to the Entity List on the basis of Section
744.11 of the EAR. These additional persons being added to the Entity
List have been determined by the U.S. Government to be acting contrary
to the national security or foreign policy interests of the United
States. The first rule that added persons to the Entity List on the
basis of Section 744.11 of the EAR was published on September 22, 2008
(73 FR 54499).
    The Entity List provides notice to the public that certain exports
and reexports to parties identified on the Entity List require a
license from the Bureau of Industry and Security (BIS) and that

availability of License Exceptions in such transactions is limited.

DATES: Effective Date: This rule is effective December 5, 2008.
Although there is no formal comment period, public comments on this
regulation are welcome on a continuing basis.

ADDRESSES: You may submit comments, identified by RIN 0694-AE48, by any
of the following methods:
    E-mail<EMAIL_ADDRESS>Include ``RIN 0694-AE48'' in the
subject line of the message.
    Fax:<PHONE_NUMBER>. Please alert the Regulatory Policy Division,
by calling<PHONE_NUMBER>, if you are faxing comments.
    Mail or Hand Delivery/Courier: Timothy Mooney, U.S. Department of
Commerce, Bureau of Industry and Security, Regulatory Policy Division,
14th St. & Pennsylvania Avenue, NW., Room 2705, Washington, DC 20230,
Attn: RIN 0694-AE48.
    Send comments regarding the collection of information associated
with this rule, including suggestions for reducing the burden, to
Jasmeet K. 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, 14th St. & Pennsylvania Avenue, NW., Room 2705, Washington,
DC 20230. Comments on this collection of information should be
submitted separately from comments on the final rule (i.e. RIN 0694-
AE48)--all comments on the latter should be submitted by one of the
three methods outlined above.

FOR FURTHER INFORMATION CONTACT: Karen Nies-Vogel, End-User Review
Committee, Office of the Assistant Secretary, Export Administration,
Bureau of Industry and Security, Department of Commerce, Phone: (202)
482-3811, Fax:<PHONE_NUMBER>, E-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    In Supplement No. 4 to part 744 (The Entity List), this rule adds
fifteen (15) persons to the Entity List on the basis of Section 744.11
of the EAR. In total, this rule adds 16 new entries to the Entity List,
including one additional entry for a newly added person with multiple
addresses. The Entity List provides notice to the public that certain
exports and reexports to parties identified on the Entity List require
a license from the Bureau of Industry and Security (BIS) and that
availability of License Exceptions in such transactions is limited.
    These additional persons being added to the Entity List have been
determined by the U.S. Government to be acting contrary to the national
security or foreign policy interests of the United States.
Specifically, these parties are of concern to the United States
Government under Section 744.11 (License Requirements that Apply to
Entities Acting Contrary to the National Security or Foreign Policy
Interests of the United States) of the EAR.

ERC Entity List Decisions

    Pursuant to Supplement No. 5 to Part 744 (Procedures for End-User
Review Committee Entity List Decisions), the End-User Review Committee
(ERC) made the decision to add these 15 persons to the Entity List on
the basis of Section 744.11. The ERC, composed of representatives of
the Departments of Commerce, State, Defense, Energy and, where
appropriate, the Treasury, makes all decisions to make additions to,
removals from or changes to the Entity List. The ERC is chaired by the
Department of Commerce and will make all decisions to add an entry to
the Entity List by majority vote and all decisions to remove or modify
an entry by unanimous vote.
    The ERC reviewed Section 744.11(b) (Criteria for Revising the
Entity List) in making this determination to add these persons to the
Entity List. Under that paragraph, entities for which there is
reasonable cause to believe, based on specific and articulable facts,
that the entity has been involved, is involved, or poses a significant
risk of being or becoming involved in activities that are contrary to
the national security or foreign policy interests of the United States
and those acting on behalf of such entities may be added to the Entity
List pursuant to Section 744.11.
    Paragraph (b) includes an illustrative list of activities that
could be contrary to the national security or foreign policy interests
of the United States. This illustrative list of activities of concern
is described under paragraphs (b)(1)-(b)(5). The persons being added to
the Entity List with this rule have been determined by the ERC to be
involved in activities that could be contrary to the national security
or foreign policy interests of the United States.

Implementation of the ERC Decision

    This rule implements the decision of the ERC to add these 15
persons to the Entity List on the basis of Section 744.11 of the EAR.
For all of the persons being added to the Entity List, the ERC decided
to specify a license requirement for all items subject to the EAR and
establish a license application review policy of a general policy of
denial. A license requirement applies to any transaction in which items
are to be exported or reexported to such persons or in which such
persons act as purchaser, intermediate consignee, ultimate consignee,
or end-user. In addition, the ERC decided that no license exceptions
are available for shipments to those persons being added to the Entity
List.
    Specifically, this rule adds the following 15 persons/16 entries to
the Entity List:
Iran
    (1) Amir Hosein Atabaki, 5 Yaas St, Unit 4, Tehran, Iran;
    (2) H. Farahani, Ground Floor--No. 31, Alborz Alley, EnghelabSt,
Tehran, Iran;
    (3) Mahdi Electronics, Ground Floor--No. 31 Alborz Alley,
EnghelabSt, Tehran, Iran;
    (4) Naser Golshekan, Ground Floor--No. 31, Alborz Alley,
EnghelabSt, Tehran, Iran;
    (5) Pakgostar Company, Appt 501 & 502, Borje Sefid Bldg, Pasadaran
Avenue, Tehran<PHONE_NUMBER>, Iran;
    (6) Raht Aseman, No. 1.2, Mosque Alley, Mohammadi St, North Bahar
Ave, Tehran, Iran;
    (7) Reza Zahedipour, 5 Yaas St, Unit 4, Tehran, Iran;
    (8) Safir Electronics, Ground Floor--No. 31 Alborz Alley,
EnghelabSt. Tehran, Iran; and
    (9) Sahab Phase, 5 Yaas St, Unit 4 Tehran, Iran.
Singapore
    (10) Brian Douglas Woodford, 1 Scotts Road, Suite 25-06 Shaw
Centre, Singapore 228208 (See alternate listing under the United
Kingdom);
    (11) Gryphon Aerospace, 36 Lorong N Telok Kurau Unit 03-
03, Singapore 425160;
    (12) Monarch Aviation, 1 Scotts Road, Suite 25-06 Shaw Centre,
Singapore 228208; and
    (13) Yip Kum Kuan, 36 Lorong N Telok Kurau, Unit 03-03,
Singapore 425160.
United Kingdom
    (14) Brian Douglas Woodford, (See alternate address under
Singapore);
    (15) Farshid Gillardian, a.k.a., Isaac Gill, Isaac Gillardian,
London, United Kingdom; and
    (16) MCES, London, United Kingdom.
    Under these entries on the Entity List, a BIS license is required
for the export or reexport of any item subject to the EAR to any of the
persons listed above,

including any transaction in which any of the listed persons will act
as purchaser, intermediate consignee, ultimate consignee, or end-user
of the items. This listing of these persons also prohibits the use of
License Exceptions (see part 740 of the EAR) for exports and reexports
of items subject to the EAR involving such persons.

Technical Corrections and Clarifications to Previously Listed Entities

    This rule makes two technical corrections, to correct two
inadvertent misspellings of Kuala Lumpur that were included in two
Malaysian entities added to the Entity List in the EAR final rule
published on September 22, 2008 (73 FR 54499). In addition, this rule
makes a clarification to one U.A.E. entity added to the Entity List, in
the final rule published on September 22, 2008. This U.A.E. entity,
Advanced Technology General Trading Company, is a co-located entity
with addresses listed under the U.A.E. and Kuwait. However, the same
Kuwaiti address was listed under both the U.A.E. and Kuwaiti entries
for this entity. This rule removes the Kuwaiti address from the U.A.E.
entry of this entity and provides a cross reference to the alternate
address under Kuwait.

Savings Clause

    Shipments of items removed from eligibility for a License Exception
or export or reexport without a license (NLR) as a result of this
regulatory action that were on dock for loading, on lighter, laden
aboard an exporting or reexporting carrier, or en route aboard a
carrier to a port of export or reexport, on December 5, 2008, pursuant
to actual orders for export or reexport to a foreign destination, may
proceed to that destination under the previous eligibility for a
License Exception or export or reexport without a license (NLR) so long
as they are exported or reexported before January 5, 2009. Any such
items not actually exported or reexported before midnight, on January
5, 2009, require a license in accordance with this rule.
    Although the Export Administration Act expired on August 20, 2001,
the President, through Executive Order 13222 of August 17, 2001, 3 CFR,
2001 Comp., p. 783 (2002), as extended by the Notice of July 23, 2008,
73 FR 43603 (July 23, 2008), has continued the Export Administration
Regulations in effect under the International Emergency Economic Powers
Act.

Rulemaking Requirements

    1. This rule has been determined to be not significant for purposes
of Executive Order 12866.
    2. Notwithstanding any other provision of law, no person is
required to respond to nor be 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 involves
collections previously approved by the OMB under control numbers 0694-
0088, ``Multi-Purpose Application,'' 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. Total burden hours associated with the Paperwork Reduction
Act and Office and Management and Budget control number 0694-0088 are
expected to increase slightly as a result of this rule.
    3. This rule does not contain policies with Federalism implications
as that term is defined in Executive Order 13132.
    4. The provisions of the Administrative Procedure Act (5 U.S.C.
553) requiring notice of proposed rulemaking, the opportunity for
public participation, and a delay in effective date, are inapplicable
because this regulation involves a military or foreign affairs function
of the United States. (See 5 U.S.C. 553(a)(1)). Further, no other law
requires that a notice of proposed rulemaking and an opportunity for
public comment be given for this rule. Because a notice of proposed
rulemaking and an opportunity for public comment are not required to be
given for this rule by 5 U.S.C. 553, or by any other law, the
analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601
et seq., are not applicable.

List of Subjects in 15 CFR Part 744

    Exports, Reporting and recordkeeping requirements, Terrorism.

0
Accordingly, part 744 of the Export Administration Regulations (15 CFR
parts 730-774) is amended as follows:

PART 744--[AMENDED]

0
1. The authority citation for 15 CFR part 744 is revised to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22
U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179;
E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59
FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 12947, 60 FR 5079, 3 CFR,
1995 Comp., p. 356; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 208; E.O. 13222,
66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 49079, 3
CFR, 2001 Comp., p. 786; Notice of July 23, 2008, 73 FR 43603 (July
25, 2008); Notice of November 10, 2008, 73 FR 67097 (November 12,
2008).

0
2. Supplement No. 4 to part 744 is amended:
0
(a) By adding under Iran, in alphabetical order, nine Iranian entities;
0
(b) By revising under Malaysia, two Malaysian entities;
0
(c) By adding under Singapore, in alphabetical order, four Singaporean
entities;
0
(d) By revising under United Arab Emirates, one U.A.E. entity, and
0
(e) By adding, in alphabetical order, the country of the United Kingdom
and three UK entities, to read as follows:

                                                        Supplement No. 4 to Part 744--Entity List
--------------------------------------------------------------------------------------------------------------------------------------------------------
              Country                         Entity                   License requirement        License review policy     Federal Register citation
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
Iran..............................  Amir Hosein Atabaki, 5      For all items subject to the      Presumption of denial  73 FR [INSERT FR PAGE NUMBER]
                                     Yaas St, Unit 4, Tehran,    EAR. (See Sec.   744.11 of the                           12/5/08.
                                     Iran.                       EAR).

                                                                      * * * * * * *
                                    H. Farahani, Ground Floor-- For all items subject to the      Presumption of denial  73 FR [INSERT FR PAGE NUMBER]
                                     No. 31, Alborz Alley,       EAR. (See Sec.   744.11 of the                           12/5/08.
                                     EnghelabSt, Tehran, Iran.   EAR).

                                                                      * * * * * * *
                                    Mahdi Electronics, Ground   For all items subject to the      Presumption of denial  73 FR [INSERT FR PAGE NUMBER]
                                     Floor--No. 31 Alborz        EAR. (See Sec.   744.11 of the                           12/5/08.
                                     Alley, EnghelabSt,          EAR).
                                     Tehran, Iran.

                                                                      * * * * * * *
                                    Naser Golshekan, Ground     For all items subject to the      Presumption of denial  73 FR [INSERT FR PAGE NUMBER]
                                     Floor--No. 31, Alborz       EAR. (See Sec.   744.11 of the                           12/5/08.
                                     Alley, EnghelabSt,          EAR).
                                     Tehran, Iran.

                                                                      * * * * * * *
                                    Pakgostar Company, Appt     For all items subject to the      Presumption of denial  73 FR [INSERT FR PAGE NUMBER]
                                     501 & 502, Borje Sefid      EAR. (See Sec.   744.11 of the                           12/5/08.
                                     Bldg, Pasadaran Avenue,     EAR).
                                     Tehran<PHONE_NUMBER>, Iran.

                                                                      * * * * * * *
                                    Raht Aseman, No. 1.2,       For all items subject to the      Presumption of denial  73 FR [INSERT FR PAGE NUMBER]
                                     Mosque Alley, Mohammadi     EAR. (See Sec.   744.11 of the                           12/5/08.
                                     St, North Bahar Ave,        EAR).
                                     Tehran, Iran.
                                    Reza Zahedipour, 5 Yaas     For all items subject to the      Presumption of denial  73 FR [INSERT FR PAGE NUMBER]
                                     St, Unit 4, Tehran, Iran.   EAR. (See Sec.   744.11 of the                           12/5/08.
                                                                 EAR).
                                    Safir Electronics, Ground   For all items subject to the      Presumption of denial  73 FR [INSERT FR PAGE NUMBER]
                                     floor No. 31 Alborz         EAR. (See Sec.   744.11 of the                           12/5/08.
                                     Alley, EnghelabSt.          EAR).
                                     Tehran, Iran.
                                    Sahab Phase, 5 Yaas St,     For all items subject to the      Presumption of denial  73 FR [INSERT FR PAGE NUMBER]
                                     Unit 4 Tehran, Iran.        EAR. (See Sec.   744.11 of the                           12/5/08.
                                                                 EAR).

                                                                      * * * * * * *
Malaysia..........................  Analytical Solutions,       For all items subject to the      Presumption of denial  73 FR 54508 9/22/08.
                                     GB (Ground         EAR. (See Sec.   744.11 of the                          73 FR [INSERT FR PAGE NUMBER]
                                     Floor), Pearl Tower, O.G.   EAR).                                                    12/5/08.
                                     Heights, Jalan Awan Cina,
                                     58200 Kuala Lumpur,
                                     Malaysia.

                                                                      * * * * * * *
                                    Mohd Ansari, GB    For all items subject to the      Presumption of denial  73 FR 54508 9/22/08.
                                     (Ground Floor), Pearl       EAR. (See Sec.   744.11 of the                          73 FR [INSERT FR PAGE NUMBER]
                                     Tower, O.G. Heights,        EAR).                                                    12/5/08.
                                     Jalan Awan Cina, 58200
                                     Kuala Lumpur, Malaysia.

                                                                      * * * * * * *
Singapore.........................  Brian Douglas Woodford, 1   For all items subject to the      Presumption of denial  73 FR [INSERT FR PAGE NUMBER]
                                     Scotts Road, Suite 25-06    EAR. (See Sec.   744.11 of the                           12/5/08.
                                     Shaw Centre, Singapore      EAR).
                                     228208 (See alternate
                                     address under the United
                                     Kingdom).

                                                                      * * * * * * *
                                    Gryphon Aerospace, 36       For all items subject to the      Presumption of denial  73 FR [INSERT FR PAGE NUMBER]
                                     Lorong N Telok Kurau Unit   EAR. (See Sec.   744.11 of the                           12/5/08.
                                     03-03, Singapore   EAR).
                                     425160.
                                    Monarch Aviation, 1 Scotts  For all items subject to the      Presumption of denial  73 FR [INSERT FR PAGE NUMBER]
                                     Road, Suite 25-06 Shaw      EAR. (See Sec.   744.11 of the                           12/5/08.
                                     Centre, Singapore 228208.   EAR).

                                                                      * * * * * * *
                                    Yip Kum Kuan, 36 Lorong N   For all items subject to the      Presumption of denial  73 FR [INSERT FR PAGE NUMBER]
                                     Telok Kurau, Unit 03-03, Singapore 425160.  EAR).

                                                                      * * * * * * *
United Arab Emirates..............  Advanced Technology         For all items subject to the      Presumption of denial  73 FR 54509 9/22/08.
                                     General Trading Company,    EAR. (See Sec.   744.11 of the                          73 FR [INSERT FR PAGE NUMBER]
                                     U.A.E. (See alternate       EAR).                                                    12/5/08.
                                     address under Kuwait).

                                                                      * * * * * * *
United Kingdom....................  Brian Douglas Woodford      For all items subject to the      Presumption of denial  73 FR [INSERT FR PAGE NUMBER]
                                     (See alternate address      EAR. (See Sec.   744.11 of the                           12/5/08.
                                     under Singapore).           EAR).
                                    Farshid Gillardian,         For all items subject to the      Presumption of denial  73 FR [INSERT FR PAGE NUMBER]
                                     a.k.a., Isaac Gill, Isaac   EAR. (See Sec.   744.11 of the                           12/5/08.
                                     Gillardian, London,         EAR).
                                     United Kingdom.
                                    MCES, London, United        For all items subject to the      Presumption of denial  73 FR [INSERT FR PAGE NUMBER]
                                     Kingdom.                    EAR. (See Sec.   744.11 of the                           12/5/08.
                                                                 EAR).
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Dated: December 2, 2008.
Christopher R. Wall,
Assistant Secretary for Export Administration.
[FR Doc. E8-28872 Filed 12-4-08; 8:45 am]

BILLING CODE 3510-33-P


[Federal Register: June 22, 2006 (Volume 71, Number 120)]
[Proposed Rules]
[Page 35858-35859]
[DOCID:fr22jn06-36]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-R04-SFUND-2006-0228; FRL-8187-9]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of intent to delete the Davie Landfill Superfund Site
from the National Priorities List.

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

SUMMARY: EPA Region 4 is issuing a notice of intent to delete the Davie
Landfill Superfund Site (Site) located in Davie, Florida, from the
National Priorities List (NPL) and requests public comments on this
notice of intent. The NPL, promulgated pursuant to section 105 of the
Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA) of 1980, as amended, is found at Appendix B of 40 CFR part 300
which is the National Oil and Hazardous Substances Pollution
Contingency Plan (NCP). EPA and the State of Florida, through the
Florida Department of Environmental Protection (FDEP), have determined
that all appropriate response actions under CERCLA, other than
operation and maintenance and five-year reviews, have been completed.
However, this deletion does not preclude future actions under
Superfund.
    In the Final Rules Section of this Federal Register, the EPA is
approving the direct final notice of deletion of the Davie Landfill
Superfund Site without prior proposal because the Agency views this as
a noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
notice. If no significant, material, and adverse comments are received
in response to this notice, no further activity is contemplated. If EPA
receives adverse comments, the direct final notice will be withdrawn
and all public comments received will be addressed in a subsequent
final notice based on this proposed notice. The EPA will not institute
a second comment period on this document. Any parties interested in
commenting on this document should do so at this time.

DATES: Comments concerning this Site must be received by July 24, 2006.

ADDRESSES: Submit your comments, identified by EPA-R04-SFUND-2006-0228
by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``(EPA-R04-SFUND-2006-0228)'', Superfund Remedial Section
C, Superfund Remedial & Technical Services Branch, Waste Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street, SW., Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier: Scott M. Martin, Remedial Project
Manager, Waste Management Division, U.S. Environmental Protection
Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960.
Such deliveries are only accepted during the Regional Office's normal
hours of operation. The Regional Office's official hours of business
are Monday through Friday, 8:30 to 4:30, excluding federal holidays.
    Please see the direct final notice which is located in the Rules
section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Scott M. Martin, Remedial Project
Manager, Superfund Remedial Section C, Superfund Remedial & Technical
Services Branch, Waste Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia
30303-8960. The telephone number is<PHONE_NUMBER>. Mr. Martin can also
be reached via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For additional information see the direct
final notice which is published in the Rules Section of this Federal
Register.
    Information Repositories: Repositories have been established to
provide detailed information concerning this decision at the following
address: Davie Landfill Superfund Site Repository, Broward County Main
Public Library, 100 S. Andrews Ave., Level 5, Ft. Lauderdale, Florida
33301.
    U.S. EPA Record Center, attn: Ms. Debbie Jourdan, Atlanta Federal
Center, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960, Phone:
(404) 562-8862, Hours: 8 a.m. to 4 p.m., Monday through Friday by
appointment only.

    Dated: June 8, 2006.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.
[FR Doc. 06-5596 Filed 6-21-06; 8:45 am]

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[Federal Register Volume 87, Number 148 (Wednesday, August 3, 2022)]
[Notices]
[Pages 47432-47433]
[FR Doc No: 2022-16570]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1436]

Peripheral and Central Nervous System 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.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Peripheral and Central Nervous
System 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 virtually on September 7, 2022, from 12
noon to 6:30 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings 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-2022-N-1436. The docket will close on
September 6, 2022. Either electronic or written comments on this public
meeting must be submitted by September 6, 2022. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 6, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
    Comments received on or before August 23, 2022, will be provided to
the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    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-2022-N-1436 for ``Peripheral and Central Nervous System 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,<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.'' 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.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: Jessica Seo, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-7699, 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 meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. The committee
will discuss new drug application (NDA) 216660, for sodium
phenylbutyrate/taurursodiol (AMX0035) powder for oral suspension,
submitted by Amylyx Pharmaceuticals Inc., for the treatment of
amyotrophic lateral sclerosis.
    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 on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference meeting room will be available at
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide presentations with audio components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before August 23, 2022, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 3:15 p.m. and 4:15 p.m. Eastern Time. 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 August 15, 2022. 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 August 16, 2022.
    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 Jessica Seo (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: July 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16570 Filed 8-2-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 117 (Thursday, June 18, 2015)]
[Notices]
[Pages 34909-34910]
[FR Doc No: 2015-14982]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1777]

Factors To Consider When Making Benefit-Risk Determinations for
Medical Device Investigational Device Exemptions; Draft Guidance for
Investigational Device Exemption Sponsors, Sponsor-Investigators, and
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Factors to Consider When
Making Benefit-Risk Determinations for Medical Device Investigational
Device Exemptions (IDEs).'' The purpose of this draft guidance is to
provide greater clarity for FDA staff and IDE sponsors and sponsor-
investigators regarding the principal factors that FDA considers when
assessing the benefits and risks of IDE applications for human clinical
study. The draft guidance also characterizes benefits in the context of
investigational research, which includes direct benefits to the
subjects and benefits to others (to the extent they are indirect
benefits to subjects or reflect the importance of knowledge to be
gained). 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 September 16, 2015.

ADDRESSES: 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 entitled
``Factors to Consider When Making Benefit-Risk Determinations for
Medical Device Investigational Device Exemptions (IDEs)'' 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;
or the Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Sugato De, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5435, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    A primary goal of this guidance is to clarify the factors that FDA
considers when assessing risks and anticipated benefits for IDE
studies, and how uncertainty may be offset by a variety of risk
mitigation measures that can assure appropriate patient and participant
protections in investigational research settings. At earlier stages of
device development, FDA considers appropriate mitigation measures for
anticipated possible risks and unanticipated risks, whereas in later
stages, risk mitigation focuses increasingly on the most probable
risks. Another important goal of this guidance is to characterize
benefits in the context of investigational research, which includes
direct benefits to the subjects and benefits to others (to the extent
they are indirect benefits to subjects or reflect the importance of
knowledge to be gained).
    As with the benefit-risk framework for evaluating marketing
applications, FDA assessment of benefits and risks for an IDE
application takes into account the contextual setting in which the
study is being proposed, including but not limited to characterization
of the disease or condition being treated or diagnosed, the
availability of alternative treatments or diagnostics, and the risks
associated with them. When available, information characterizing
subject tolerance for risk

and perspective on benefit may provide useful context during this
assessment.
    FDA believes use of this benefit-risk framework in an IDE
application will facilitate the incorporation of evidence and knowledge
from different domains--clinical, nonclinical, and patient--to support
a comprehensive, balanced decision-making approach. FDA envisions this
will facilitate a common understanding between FDA and sponsors/
sponsor-investigators by highlighting which factors are critical in the
benefit-risk assessment for a specific application, and clearly
explaining how these factors influence a regulatory decision. FDA also
believes implementation of this guidance document will improve the
predictability, consistency, and transparency of the review process for
IDE applications.

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 Agency's current thinking on ``Factors to
Consider When Making Benefit-Risk Determinations for Medical Device
Investigational Device Exemptions (IDEs).'' It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute 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 or from CBER
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to
download an electronic copy of ``Factors to Consider When Making
Benefit-Risk Determinations for Medical Device Investigational Device
Exemptions'' may send an email request to<EMAIL_ADDRESS>to
receive an electronic copy of the document. Please use the document
number 1783 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. 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 812 have been approved under
OMB control number 0910-0078; the collections of information in 21 CFR
part 50.23 (Exception from general requirements for informed consent)
have been approved under OMB control number 0910-0586; the collections
of information in 21 CFR part 56.115 (IRB records) have been approved
under OMB control number 0910-0130; and the collections of information
in 21 CFR part 50, subpart B (Informed Consent of Human Subjects) and
56 (Institutional Review Boards) have been approved under OMB control
number 0910-0755.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: June 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14982 Filed 6-17-15; 8:45 am]
BILLING CODE 4164-01-P