[Federal Register: July 21, 2006 (Volume 71, Number 140)]
[Notices]
[Page 41432-41433]
[DOCID:fr21jy06-40]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Sunshine Act Meeting; Notice

July 13, 2006.
    The following notice of meeting is published pursuant to section
3(a) of the government in the Sunshine Act (Pub. L. 94-409), 5 U.S.C
552b:

Agency Holding Meeting: Federal Energy Regulatory Commission.

Date and Time: July 20, 2006. 10 a.m.

Place: Room 2C, 888 First Street, NE., Washington, DC 20426.

Status: Open.

Matters to be Considered: Agenda: *Note--Items listed on the agenda may
be deleted without further notice.

Contact Person For More Information: Magalie R. Salas, Secretary,
Telephone:<PHONE_NUMBER>.
    For a recorded listing item stricken from or added to the meeting,
call<PHONE_NUMBER>.
    This is a list of matters to be considered by the Commission. It
does not include a listing of all papers relevant to the items on the
agenda; however, all public documents may be examined in the Public
Reference Room.

907th--Meeting

Regular Meeting: July 20, 2006; 10 a.m.

----------------------------------------------------------------------------------------------------------------
          Item No.                     Docket No.                                  Company
----------------------------------------------------------------------------------------------------------------
                                              Administrative Agenda
----------------------------------------------------------------------------------------------------------------
A-1.........................  AD02-1-000..................  Agency Administrative Matters.
A-2.........................  AD02-7-000..................  Customer Matters, Reliability, Security and Market
                                                             Operations.
A-3.........................  AD06-3-000..................  Energy Market Update.
A-4.........................  AD05-13-000.................  Joint Boards on Security Constrained Economic
                                                             Dispatch.
A-5.........................  AD06-2-000..................  Demand Response Report.
----------------------------------------------------------------------------------------------------------------
                                                    Electric
----------------------------------------------------------------------------------------------------------------
E-1.........................  RM05-34-002.................  Transactions Subject to FPA Section 203.
E-2.........................  RM06-8-000..................  Long-Term Firm Transmission Rights in Organized
                                                             Electricity Markets.
E-3.........................  RM06-4-000..................  Promoting Transmission Investment through Pricing
                                                             Reform.
E-4.........................  EL06-54-000.................  Allegheny Energy, Inc., Monongahela Power Company,
                                                             The Potomac Edison Company, and West Penn Power
                                                             Company.
E-5.........................  RR06-1-000..................  North American Electric Reliability Corporation.
E-6.........................  RR06-2-000..................  Governors of Arizona, California, Colorado, Montana,
                                                             Nevada, New Mexico, Oregon, Utah, Washington and
                                                             Wyoming.
E-7.........................  ER05-764-000................  Montana Alberta Tie, Ltd.
                              ER05-764-002................
E-8.........................  ER06-451-002................  Southwest Power Pool, Inc.
                              ER06-1047-000...............
E-9.........................  Omitted.....................
E-10........................  ER98-1150-004                 Tucson Electric Power Company.
                              ER98-1150-005...............
                              ER98-1150-006...............
                              EL05-87-000.................
E-11........................  Omitted.....................
E-12........................  TX05-1-007..................  East Kentucky Power Cooperative, Inc.
E-13........................  ER04-230-023................  New York Independent System Operator, Inc.
E-14........................  Omitted.....................
E-15........................  EL06-50-000.................  American Electric Power Service Corporation.
E-16........................  Omitted.....................
E-17........................  EF04-3031-001...............  United States Department of Energy--Southeastern
                                                             Power Administration (Jim Woodruff Project).
E-18........................  RM02-12-002.................  Standardization of Small Generator Interconnection
                                                             Agreements and Procedures.
E-19........................  Omitted.....................
E-20........................  ER06-448-001................  Southwest Power Pool, Inc.

E-21........................  EL04-87-000.................  Southern Company Services, Inc.
                              ER04-563-002................
                              ER04-563-003................
                              ER05-413-003................
                              ER05-413-004................
                              ER03-379-003................
                              ER03-355-004................
                              ER05-518-002................
E-22........................  Omitted.....................
----------------------------------------------------------------------------------------------------------------
                                                  Miscellaneous
----------------------------------------------------------------------------------------------------------------
M-1.........................  RM05-32-002.................  Repeal of the Public Utility Holding Company Act of
                                                             1935 and Enactment of the Public Utility Holding
                                                             Company Act of 2005.
----------------------------------------------------------------------------------------------------------------
                                                       Gas
----------------------------------------------------------------------------------------------------------------
 G-1........................  OR06-8-000..................  Colonial Pipeline Company.
G-2.........................  TS06-8-000..................  High Island Offshore System, L.L.C.
                              TS06-9-000..................  Petal Gas Storage, L.L.C.
                              TS05-13-000.................  NGO Transmission, Inc.
                              TS04-286-001................  Exelon Corporation.
                              TS04-287-001
                              TS06-10-000.................  Ozark Gas Transmission, L.L.C.
                              TS05-9-000..................  Texas Gas Service Company.
                              TS04-3-001..................  NorthWestern Energy.
                              TS04-260-001................  Williston Basin Interstate Pipeline.
                              TS05-18-000.................  Attala Transmission, L.L.C.
                              TS06-1-000..................  The Detroit Edison Company.
G-3.........................  TS04-248-001................  National Fuel Gas Distribution Corporation.
                              TS04-270-000................  Equitrans, Inc.
                              TS06-7-000..................  PacifiCorp and TransAlta Centralia Generation, LLC.
                              OA06-4-000
                              TS04-249-002................  Kinder Morgan Pipelines.
                              TS04-252-001................  Ohio Valley Electric Corporation and Indiana-
                                                             Kentucky Electric Corporation.
                              TS04-62-000.................  NewCorp Resources Electric Cooperative, Inc.
                              TS04-62-001
G-4.........................  Omitted.....................
----------------------------------------------------------------------------------------------------------------
                                                      Hydro
----------------------------------------------------------------------------------------------------------------
H-1.........................  P-6188-016..................  Sierra Hydro, Inc.
H-2.........................  P-8800-021..................  Western Hydro Electric, Inc.
H-3.........................  P-459-153...................  Union Electric Company d/b/a Ameren UE.
----------------------------------------------------------------------------------------------------------------
                                                  Certificates
----------------------------------------------------------------------------------------------------------------
C-1.........................  CP06-5-000..................  Empire State Pipeline and Empire Pipeline, Inc.
                              CP06-6-000..................
                              CP06-7-000..................
C-2.........................  CP06-71-000.................  Carolina Gas Transmission Corporation, SCG Pipe-
                              CP06-72-000.................   line, Inc. and South Carolina Pipeline Corporation.
                              CP06-73-000.................
C-3.........................  CP06-66-000.................  Port Barre Investments, L.L.C. d/b/a Bobcat Gas
                              CP06-67-000.................   Storage.
                              CP06-68-000.................
C-4.........................  CP06-18-000.................  Tennessee Gas Pipeline Company.
----------------------------------------------------------------------------------------------------------------

    A free Webcast of this event is available through http://www.ferc.gov.
 Anyone with Internet access who desires to view this

event can do so by navigating to http://www.ferc.gov's Calendar of

Events and locating this event in the Calendar. The event will contain
a link to its Webcast. The Capitol Connection provides technical
support for the free Webcasts. It also offers access to this event via
television in the DC area and via phone bridge for a fee. If you have
any questions, visit http://www.CapitolConnection.org or contact

Danelle Perkowski or David Reininger at<PHONE_NUMBER>.
    Immediately following the conclusion of the Commission Meeting, a
press briefing will be held in the Commission Meeting Room. Members of
the public may view this briefing in the designated overflow room. This
statement is intended to notify the public that the press briefings
that follow Commission meetings may now be viewed remotely at
Commission headquarters, but will not be telecast through the Capitol
Connection service.

Magalie R. Salas,
Secretary.
[FR Doc. 06-6420 Filed 7-19-06; 11:47 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3822-3825]
[FR Doc No: 2014-01223]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0731]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Human Cells, Tissues,
and Cellular and Tissue-Based Products: Establishment Registration and
Listing; Form FDA 3356; Eligibility Determination for Donors; and
Current Good Tissue Practice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
February 24, 2014.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0543.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Human Cells, Tissues, and Cellular and Tissue-Based Products:
Establishment Registration and Listing; Form FDA 3356; Eligibility
Determination for Donors; and Current Good Tissue Practice--(OMB
Control Number 0910-0543)--Extension

    Under section 361 of the Public Health Service Act (the PHS Act)
(42 U.S.C. 264), FDA may issue and enforce regulations necessary to
prevent the introduction, transmission, or spread of communicable
diseases between the States or possessions or from foreign countries
into the States. As derivatives of the human body, all Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps) pose some risk
of carrying pathogens that could potentially infect recipients or
handlers. FDA has issued regulations related to HCT/Ps involving
establishment registration and listing using Form FDA 3356, eligibility
determination for donors, and Current Good Tissue Practice (CGTP).

Establishment Registration and Listing; Form FDA 3356

    The regulations in part 1271 (21 CFR part 1271) require domestic
and foreign establishments that recover, process, store, label,
package, or distribute an HCT/P described in Sec.  1271.10(a), or that
perform screening or testing of the cell or tissue donor to register
with FDA (Sec.  1271.10(b)(1)) and submit a list of each HCT/P
manufactured (Sec.  1271.10(b)(2)). Section 1271.21(a) requires an
establishment to follow certain procedures for initial registration and
listing of HCT/Ps, and Sec.  1271.25(a) and (b) identifies the required
initial registration and HCT/P listing information. Section 1271.21(b),
in brief, requires an annual update of the establishment registration.
Section 1271.21(c)(ii) requires establishments to submit HCT/P listing
updates if a change as described in Sec.  1271.25(c) has occurred.
Section 1271.25(c) identifies the required HCT/P listing update
information. Section 1271.26 requires establishments to submit an
amendment if ownership or location of the establishment changes. FDA
requires the use of a registration and listing form (Form FDA 3356:
Establishment Registration and Listing for Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps)) to submit the required
information (Sec. Sec.  1271.10, 1271.21, 1271.25, and 1271.26). To
further facilitate the ease and speed of submissions, electronic
submission is accepted at (http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/TissueEstablishmentRegistration/default.htm).

Eligibility Determination for Donors

    In brief, FDA requires certain HCT/P establishments described in
Sec.  1271.1(b) to determine donor eligibility based on donor screening
and testing for relevant communicable disease agents and diseases
except as provided under Sec.  1271.90. The documented determination of
a donor's eligibility is made by a responsible person as defined in
Sec.  1271.3(t) and is based on the results of required donor
screening, which includes a donor medical history interview (defined in
Sec.  1271.3(n)), and testing (Sec.  1271.50(a)). Certain records must
accompany an HCT/P once the donor-eligibility determination has been
made (Sec.  1271.55(a)). This requirement applies both to an HCT/P from
a donor who is determined to be eligible as well as to an HCT/P from a
donor who is determined to be ineligible or where the donor-eligibility
determination is not complete if there is a documented urgent medical
need, as defined in Sec.  1271.3(u) (Sec.  1271.60). Once the donor-
eligibility determination has been made, the HCT/P must be accompanied
by a summary of records used to make the donor-eligibility
determination (Sec.  1271.55(b)), and a statement whether,

based on the results of the screening and testing of the donor, the
donor is determined to be eligible or ineligible (Sec.  1271.55(a)(2)).
Records used in determining the eligibility of a donor, i.e., results
and interpretations of testing for relevant communicable disease
agents, the donor-eligibility determination, the name and address of
the testing laboratory or laboratories, and the name of the responsible
person (defined in Sec.  1271.3(t)) who made the donor-eligibility
determination and the date of the determination, must be maintained
(Sec.  1271.55(d)(1)). If any information on the donor is not in
English, the original record must be maintained and translated to
English, and accompanied by a statement of authenticity by the
translator (Sec.  1271.55(d)(2)). HCT/P establishments must retain the
records pertaining to a particular HCT/P at least 10 years after the
date of its administration, or, if the date of administration is not
known, then at least 10 years after the date of the HCT/P's
distribution, disposition, or expiration, whichever is latest (Sec.
1271.55(d)(4)).
    When a product is shipped in quarantine, as defined in Sec.
1271.3(q), before completion of screening and testing, the HCT/P must
be accompanied by records identifying the donor stating that the donor-
eligibility determination has not been completed and stating that the
product must not be implanted, transplanted, infused, or transferred
until completion of the donor-eligibility determination, except in
cases of urgent medical need, as defined in Sec.  1271.3(u) (Sec.
1271.60(c)). When an HCT/P is used in cases of documented urgent
medical need, the results of any completed donor screening and testing,
and a list of any required screening and testing that has not yet been
completed also must accompany the HCT/P (Sec.  1271.60(d)(2)). When an
HCT/P is used in cases of urgent medical need or from a donor who has
been determined to be ineligible (as permitted under Sec.  1271.65),
documentation by the HCT/P establishment is required showing that the
recipient's physician received notification that the testing and
screening were not complete (in cases of urgent medical need), and upon
the completion of the donor-eligibility determination, of the results
of the determination (Sec. Sec.  1271.60(d)(3) and (d)(4), and
1271.65(b)(3).
    An HCT/P establishment is also required to establish and maintain
procedures for all steps that are performed in determining eligibility
(Sec.  1271.47(a)), including the use of a product from a donor of
viable, leukocyte-rich cells or tissue testing reactive for
cytomegalovirus (Sec.  1271.85(b)(2)). The HCT/P establishment must
record and justify any departure from a procedure relevant to
preventing risks of communicable disease transmission at the time of
its occurrence (Sec.  1271.47(d)).

Current Good Tissue Practice (CGTP)

    FDA requires HCT/P establishments to follow CGTP (Sec.  1271.1(b)).
Section 1271.155(a) permits the submission of a request for FDA
approval of an exemption from or an alternative to any requirement in
subpart C or D of part 1271. Section 1271.290(c) requires
establishments to affix a distinct identification code to each HCT/P
that they manufacture that relates the HCT/P to the donor and to all
records pertaining to the HCT/P. Whenever an establishment distributes
an HCT/P to a consignee, Sec.  1271.290(f) requires the establishment
to inform the consignee, in writing, of the product tracking
requirements and the methods the establishment uses to fulfill these
requirements. Non-reproductive HCT/P establishments described in Sec.
1271.10 are required under Sec.  1271.350(a)(1) and (a)(3) to
investigate and report to FDA adverse reactions (defined in Sec.
1271.3(y)) using Form FDA-3500A (Sec.  1271.350(a)(2)). Form FDA-3500A
is approved under OMB control number 0910-0291. Section 1271.370(b) and
(c) requires establishments to include specific information either on
the HCT/P label or with the HCT/P.
    The standard operating procedures (SOPs) provisions under part 1271
include the following: (1) Section 1271.160(b)(2) (receiving,
investigating, evaluating, and documenting information relating to core
CGTP requirements, including complaints, and for sharing information
with consignees and other establishments); (2) Sec.  1271.180(a) (to
meet core CGTP requirements for all steps performed in the manufacture
of HCT/Ps); (3) Sec.  1271.190(d)(1) (facility cleaning and
sanitization); (4) Sec.  1271.200(b) (cleaning, sanitizing, and
maintenance of equipment); (5) Sec.  1271.200(c) (calibration of
equipment); (6) Sec.  1271.230(a) and (c) (validation of a process and
review and evaluation of changes to a validated process); (7) Sec.
1271.250(a) (controls for labeling HCT/Ps); (8) Sec.  1271.265(e)
(receipt, predistribution shipment, availability for distribution, and
packaging and shipping of HCT/Ps); (9) Sec.  1271.265(f) (suitable for
return to inventory); (10) Sec.  1271.270(b) and (d) (records
management system); (11) Sec.  1271.290(b)(1) (system of HCT/P
tracking); and (12) Sec.  1271.320(a) (review, evaluation, and
documentation of complaints as defined in Sec.  1271.3(aa)).
    Section 1271.155(f) requires an establishment operating under the
terms of an exemption or alternative to maintain documentation of FDA's
grant of the exemption or approval and the date on which it began
operating under the terms of the exemption or alternative. Section
1271.160(b)(3) requires the quality program of an establishment that
performs any step in the manufacture of HCT/Ps to document corrective
actions relating to core CGTP requirements. Section 1271.160(b)(6)
requires documentation of HCT/P deviations. Section 1271.160(d)
requires, in brief, documentation of validation of computer software if
the establishment relies upon it to comply with core CGTP requirements.
Section 1271.190(d)(2) requires documentation of all cleaning and
sanitation activities performed to prevent contamination of HCT/Ps.
Section 1271.195(d) requires documentation of environmental control and
monitoring activities. Section 1271.200(e) requires documentation of
all equipment maintenance, cleaning, sanitizing, calibration, and other
activities. Section 1271.210(d) requires, in brief, documentation of
the receipt, verification, and use of each supply or reagent. Section
1271.230(a) requires documentation of validation activities and results
when the results of processing described in Sec.  1271.220 cannot be
fully verified by subsequent inspection and tests. Section 1271.230(c)
requires that when changes to a validated process subject to Sec.
1271.230(a) occur, documentation of the review and evaluation of the
process and revalidation, if necessary, must occur. Section 1271.260(d)
and (e) requires documentation of any corrective action taken when
proper storage conditions are not met and documentation of the storage
temperature for HCT/Ps. Section 1271.265(c)(1) requires documentation
that all release criteria have been met before distribution of an HCT/
P. Section 1271.265(c)(3) requires documentation of any departure from
a procedure relevant to preventing risks of communicable disease
transmission at the time of occurrence. Section 1271.265(e) requires
documentation of the activities in paragraphs (a) through (d) of this
section, which must include identification of the HCT/P and the
establishment that supplied the HCT/P, activities performed and the
results of each activity, date(s) of activity, quantity of HCT/P
subject to the

activity, and disposition of the HCT/P. Section 1271.270(a) requires
documentation of each step in manufacturing required in part 1271,
subparts C and D. Section 1271.270(e) requires documentation of the
name and address, and a list of responsibilities of any establishment
that performs a manufacturing step for the establishment. Section
1271.290(d) and (e) require documentation of a method for recording the
distinct identification code and type of each HCT/P distributed to a
consignee to enable tracking from the consignee to the donor and to
enable tracking from the donor to the consignee or final disposition.
Section 1271.320(b) requires an establishment to maintain a record of
each complaint that it receives. The complaint file must contain
sufficient information about each complaint for proper review and
evaluation of the complaint and for determining whether the complaint
is an isolated event or represents a trend.
    Respondents to this information collection are establishments that
recover, process, store, label, package or distribute any HCT/P, or
perform donor screening or testing. The estimates provided below are
based on most recent available information from FDA's database system
and trade organizations. The hours per response and hours per record
are based on data provided by the Eastern Research Group, or FDA
experience with similar recordkeeping or reporting requirements.
    There are an estimated 2,706 HCT/P establishments (conventional
tissue, eye tissue, peripheral blood stem cell, stem cell products from
cord blood, reproductive tissue, and sperm banks), including 741
manufacturers of HCT/P products regulated under the Federal Food, Drug,
and Cosmetic Act and section 351 of the PHS Act (42 U.S.C 262), that
have registered and listed with FDA. In addition, we estimate that 218
new establishments have registered with FDA (Sec. Sec.  1271.10(b)(1)
and (b)(2) and 1271.25(a) and (b)). There are an estimated 3,737
listing updates (Sec. Sec.  1271.10(b)(2), 1271.21(c)(ii), and
1271.25(c)) and 1,222 location/ownership amendments (Sec.  1271.26).
    Under Sec.  1271.55(a), an estimated total of 2,167, 396 HCT/Ps
(which include conventional tissues, eye tissues, hematopoetic stem
cells/progenitor cells, and reproductive cells and tissues), and an
estimated total of 2,026,861 non-reproductive cells and tissues (total
HCT/Ps minus reproductive cells and tissues) are distributed per year
by an estimated 1,965 establishments (2,706-741 = 1,965) with approved
applications.
    Under Sec.  1271.60(c) and (d)(2), FDA estimates that 1,375
establishments shipped an estimated 286,000 HCT/Ps under quarantine,
and that an estimated 26 establishments requested 40 exemptions from or
alternative to any requirement under part 1271, subpart C or D,
specifically under Sec.  1271.155(a).
    Under Sec. Sec.  1271.290(c) and 1271.370(b) and (c), the estimated
1,694 non-reproductive HCT/P establishments label each of their
2,026,861 HCT/Ps with certain information. These establishments are
also required to inform their consignees in writing of the requirements
for tracking and of their established tracking system under Sec.
1271.290(f).
    FDA estimates 24 HCT/P establishments submitted 206 adverse
reaction reports with 167 involving a communicable disease (Sec.
1271.350(a)(1)).
    FDA estimates that 218 new establishments will create SOPs, and
that 2,706 establishments will review and revise existing SOPs
annually.
    FDA estimates that 1,353 HCT/P establishments (2,706 x 50 percent =
1,353) and 847 non-reproductive HCT/P establishments (1,694 x 50
percent = 847) record and justify a departure from the procedures
(Sec. Sec.  1271.47(d) and 1271.265(c)(3)).
    Under Sec.  1271.50(a), HCT/P establishments are required to have a
documented medical history interview about the donor's medical history
and relevant social behavior as part of the donor's relevant medical
records for each of the estimated total of 91,756 donors (which include
conventional tissue donors, eye tissue donors, peripheral and cord
blood stem cell donors, and reproductive cell and tissue donors), and
the estimated total of 86,156 non-reproductive cells and tissue donors
(total donors minus reproductive cell and tissue donors).
    FDA estimates that 812 HCT/P establishments (2,706 x 30 percent =
812) document an urgent medical need of the product to notify the
physician using the HCT/P (Sec. Sec.  1271.60(d)(3) and 1271.65(b)(3)).
    FDA also estimates that 2,165 HCT/P establishments (2,706 x 80
percent = 2,165) have to maintain records for an average of 2 contract
establishments to perform their manufacturing process (Sec.
1271.270(e) and 1,353 HCT/P establishments maintain an average of 5
complaint records annually (Sec.  1271.320(b)).
    In some cases, the estimated burden may appear to be lower or
higher than the burden experienced by individual establishments. The
estimated burden in these charts is an estimated average burden, taking
into account the range of impact each regulation may have.
    In the Federal Register of July 12, 2013 (78 FR 41934), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
               21 CFR section                    Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.10(b)(1) and 1271.21(b) \2\............           2,706            1              2,706  .5 (30 minutes)...........................           1,353
1271.10(b)(1) and (b)(2), 1271.21(a), and                218            1                218  .75 (45 minutes)..........................             164
 1271.25(a) and (b) \2\.
1271.10(b)(2), 1271.21(c)(ii), and                     3,737            1              3,737  .5 (30 minutes)...........................           1,869
 1271.25(c) \2\.
1271.26 \2\.................................           1,222            1              1,222  .25 (15 minutes)..........................             306
1271.155(a).................................              26            1.54              40  3.........................................             120
1271.350(a)(1) and (a)(3)...................              24            8.58             206  1.........................................             206
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................           4,018
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Using Form FDA 3356.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
               21 CFR section                    Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
New SOPs \2\................................             218            1                218  48........................................          10,464
SOP Update \2\..............................           2,706            1              2,706  24........................................          64,944
1271.47(d)..................................           1,353            1              1,353  1.........................................           1,353
1271.50(a)..................................           2,706           33.91          91,756  5.........................................         458,780
1271.55(d)(1)...............................           2,706           33.91          91,756  1.........................................          91,756
1271.55(d)(2)...............................           2,706            1              2,706  1.........................................           2,706
1271.55(d)(4)...............................           2,706            1              2,706  120.......................................         324,720
1271.60(d)(3) and (d)(4) 1271.65(b)(3)......             812            1                812  2.........................................           1,624
1271.155(f).................................              26            1.54              40  .25 (15 minutes)..........................              10
1271.160(b)(3) and (b)(6)...................           1,694           12             20,328  1.........................................          20,328
1271.160(d).................................           1,694           12             20,328  1.........................................          20,328
1271.190(d)(2)..............................           1,694           12             20,328  1.........................................          20,328
1271.195(d).................................           1,694           12             20,328  1.........................................          20,328
1271.200(e).................................           1,694           12             20,328  1.........................................          20,328
1271.210(d).................................           1,694           12             20,328  1.........................................          20,328
1271.230(a).................................           1,694           12             20,328  1.........................................          20,328
1271.230(c).................................           1,694            1              1,694  1.........................................           1,694
1271.260(d).................................           1,694           12             20,328  .25 (15 minutes)..........................           5,082
1271.260(e).................................           1,694          365            618,310  .083 (5 minutes)..........................          51,320
1271.265(c)(1)..............................           1,694        1,196.49       2,026,861  .083 (5 minutes)..........................         168,229
1271.265(c)(3)..............................             847            1                847  1.........................................             847
1271.265(e).................................           1,694        1,196.49       2,026,861  .083 (5 minutes)..........................         168,229
1271.270(a).................................           1,694        1,196.49       2,026,861  .25 (15 minutes)..........................         506,715
1271.270(e).................................           2,165            2              4,330  .5 (30 minutes)...........................           2,165
1271.290(d) and (e).........................           1,694           50.86          86,156  .25 (15 minutes)..........................          21,539
1271.320(b).................................           1,353            5              6,765  1.........................................           6,765
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................       2,031,238
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Sections 1271.47(a), 1271.85(b)(2), 1271.160(b)(2) and (d)(1), 1271.180(a), 1271.190(d)(1), 1271.200(b), 1271.200(c), 1271.230(a) and (c),
  1271.250(a), 1271.265(e) and (f), 1271.270(b) and (d), 1271.290(b)(1), and 1271.320(a).

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                                                 Number of      disclosures    Total annual
               21 CFR section                   respondents         per         Disclosures          Average burden per disclosure          Total hours
                                                                respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.55(a)..................................           1,965        1,103          2,167,396  .5 (30 minutes)...........................       1,083,698
1271.60(c) and (d)(2).......................           1,375          208            286,000  .5 (30 minutes)...........................         143,000
1271.290(c).................................           1,694        1,196.49       2,026,861  .083 (5 minutes)..........................         168,229
1271.290(f).................................           1,694            1              1,694  1.........................................           1,694
1271.370(b) and (c).........................           1,694        1,196.49       2,026,861  .25 (15 minutes)..........................         506,715
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................       1,903,336
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: January 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01223 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 140 (Wednesday, July 22, 2015)]
[Rules and Regulations]
[Pages 43314-43320]
[FR Doc No: 2015-17981]

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

DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 734, 736, 740, 742, 746, 748, 750, 758, 772, and 774

[Docket No. 150416374-5374-01]
RIN 0694-AG60

Cuba: Implementing Rescission of State Sponsor of Terrorism
Designation

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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

SUMMARY: This rule amends the Export Administration Regulations (EAR)
to implement the rescission of Cuba's designation as a State Sponsor of
Terrorism. Specifically, this rule removes anti-terrorism (AT) license
requirements from Cuba and eliminates references to Cuba as a State
Sponsor of Terrorism, but maintains preexisting license requirements
for all items subject to the EAR unless authorized by a license
exception. This rule also removes Cuba from Country Group E:1
(terrorist supporting countries), which makes Cuba eligible for a
general 25 percent de minimis level and portions of four license
exceptions. The Secretary of State rescinded the designation of Cuba as
a State Sponsor of Terrorism on May 29, 2015.

DATES: This rule is effective July 22, 2015.

FOR FURTHER INFORMATION CONTACT: Foreign Policy Division, Office of
Nonproliferation and Treaty Compliance, Bureau of Industry and
Security, Phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Contents

I. Background
II. Removal of Anti-Terrorism Controls and Text Associating Cuba
With Terrorism
III. Jurisdiction--Items That Are Subject to the Ear
    A. Items With More Than de minimis Controlled U.S. Origin
Content
    B. Items That Are the Direct Product of U.S.-Origin National
Security Technology or Software
IV. Provisions Impacted by Cuba's Removal From County Group E:1
V. Provisions Being Amended To Retain Existing Cuba-Related
Requirements

I. Background

    The United States maintains a comprehensive embargo on trade with
Cuba. Pursuant to that embargo, all items that are subject to the
Export Administration Regulations (EAR) require a license for export or
reexport to Cuba unless authorized by a license exception. The Bureau
of Industry and Security (BIS) administers export and reexport
restrictions on Cuba consistent with the goals of that embargo and with
relevant law. Accordingly, BIS may issue specific or general
authorizations in the form of licenses or license exceptions for
transactions that support the goals of United States policy while the
embargo remains in effect.
    On December 17, 2014, the President announced that the United
States is taking steps to chart a new course in bilateral relations
with Cuba and to further engage and empower the Cuban people. As one of
these steps, the President directed the Secretary of State to review
Cuba's designation as a State Sponsor of Terrorism and provide a report
to the President within six months. Cuba was designated as a State
Sponsor of Terrorism in 1982. Pursuant to Sections 6(a) and 6(j) of the
Export Administration Act of 1979, as amended (EAA), State Sponsors of
Terrorism are subject to anti-terrorism (AT) controls and certain other
restrictions in the EAR. Once designated, a country remains a State
Sponsor of Terrorism until its designation is rescinded in accordance
with the relevant statutes (Section 6(j) of the EAA; Section 40 of the
Arms Export Control Act of 1976, as amended; and Section 620A of the
Foreign Assistance Act of 1961, as amended).
    There are two possible paths to rescission of a State Sponsor of
Terrorism designation under the relevant statutes. The first requires
the President to submit a report to Congress before the proposed
rescission would take effect certifying that (1) there has been a
fundamental change in the leadership and policies of the government of
the country concerned, (2) the government is not supporting acts of
international terrorism, and (3) the government has provided assurances
that it will not support acts of international terrorism in the future.
The second path requires that the President submit a report to
Congress, at least 45 days before the proposed rescission would take
effect, justifying the rescission and certifying the subject government
has not provided any support for international terrorism for the
preceding six-month period and has given assurances that it will not
support acts of international terrorism in the future. The rescission
of Cuba's designation was done consistent with the second path.
    On April 8, 2015, the Secretary of State completed the review
requested by the President and submitted his analysis to the President
recommending that Cuba should no longer be designated as a State
Sponsors of Terrorism. On April 14, 2015, the President submitted to
Congress the statutorily required report indicating the
Administration's intent to rescind Cuba's State Sponsor of Terrorism
designation, including the certification that Cuba has not provided any
support for international terrorism during the previous six months; and
that Cuba has provided assurances that it will not support acts of
international terrorism in the future. The Secretary of State then made
the final decision to rescind Cuba's designation as a State Sponsor of
Terrorism, which was effective on May 29, 2015. Accordingly, this rule
removes references to Cuba as a State Sponsor of Terrorism and removes
anti-terrorism (AT) controls from Cuba.
    However, Cuba is still subject to a comprehensive embargo and, as
specified in Sec.  746.2(a) of the EAR, a license is still required to
export or reexport to Cuba any item subject to the EAR unless
authorized by a license exception. Only those license exceptions listed
in Sec.  746.2(a) may be used to export or reexport to Cuba. These
requirements of Sec.  746.2(a) apply to all items subject to the EAR,
including EAR99 items and items that are controlled on the Commerce
Control List (CCL) only for AT reasons.

II. Removal of Anti-Terrorism Controls and Text Associating Cuba With
Terrorism

    This rule removes:
     The reference to ``counter-terrorism'' from the licensing
policy that applies to certain exports intended to provide support for
the Cuban people that appears in Sec.  746.2(b)(4)(i) (which will be
redesignated as Sec.  746.2(b)(3)(i));
     Sec.  746.2(c), which identifies Cuba as a country whose
government has repeatedly provided support for acts of international
terrorism;
     the references to ``terrorism'' and ``state sponsors of
terrorism'' from Sec.  746.2(e), which describes the license
requirements regarding Cuba of the U.S. Department of the Treasury,
Office of Foreign Assets Control and the U.S. Department of State; and
     the word ``Cuba'' from the statements of anti-terrorism
license requirements in Export Control Classification Numbers 1C350,
1C355, 1C395, 2A994, 2D994 and 2E994.
    This rule also removes Cuba from the following provisions, which
list countries that have been designated as State Sponsors of Terrorism
or that have repeatedly supported acts of international terrorism:
Sec.  742.1(d); Supplement No. 2 to part 742,

paragraphs (a) and (b)(1); Sec.  750.4(b)(6)(i); and Sec.  772.1,
definition of ``countries supporting international terrorism.''
    Finally, this rule removes Cuba from Country Group E:1--Terrorist
Supporting Countries--in Supplement No. 1 to Part 740--Country Groups.
However, Cuba remains in Country Group E:2--Unilateral embargo. Cuba
also remains in Country Groups D:2, D:3, and D:5. Because country
groups are used to specify the countries that are subject to certain
provisions of the EAR, particularly license exceptions, and to impose
certain restrictions, removal of Cuba from Country Group E:1 can have
effects elsewhere in the EAR as will be discussed below.

III. Jurisdiction--Items That Are Subject to the EAR

A. Items With More Than de minimis Controlled U.S. Origin Content

    The EAR apply to items that contain more than a de minimis amount
of controlled U.S.-origin content including foreign-made items located
outside the United States. For most items, the de minimis level is 10
percent if the destination of the foreign-made item is in Country Group
E:1 and 25 percent if the destination is elsewhere. The removal of Cuba
from Country Group E:1 raises the de minimis level to 25 percent for
most items destined for Cuba. Additionally, since Cuba is no longer in
Country Group E:1, the 25 percent de minimis level now applies to
certain foreign-made encryption items destined for Cuba that meet the
criteria specified in Sec.  734.4(b)(1)(iii) of the EAR.
    With the general increase in the de minimis level to 25 percent,
paragraph (b)(3) of Sec.  746.2, which described the circumstances
under which foreign made items containing an insubstantial proportion
of U.S. origin content (i.e., not exceeding 20 percent) would generally
be considered favorably, is no longer needed, so this rule removes that
paragraph.
    Foreign-made items destined for Cuba that incorporate U.S.-origin
9x515 or ``600 series'' .y content continue to be subject to the EAR
regardless of the level of U.S.-origin content, i.e., there is no de
minimis for these items when destined for Cuba. To maintain this
exclusion with respect to Cuba, this rule adds Country Group E:2 to the
list of destinations (Country Group E:1 and the People's Republic of
China) subject to that exclusion. Since 9x515 and ``600 series'' .y
items are ``specially designed'' items transferred from the United
States Munitions List to the CCL, this de minimis exclusion is still
warranted for countries subject to unilateral embargo. Accordingly, BIS
is amending Sec.  734.4(a)(6)(ii) to include Country Group E:2.

B. Items That Are the Direct Product of U.S.-Origin National Security
Technology and Software

    The EAR apply to foreign-made national security items that are the
direct product of U.S.-origin national security technology and
software. Such items are subject to the EAR (and require a license) if
destined to a country in Country Group D:1 or E:1. This rule retains
Cuba as one of the destinations that is subject to this requirement by
adding Country Group E:2 to Sec.  736.2(b)(3).

IV. Provisions Impacted by Cuba's Removal From County Group E:1

    The provisions of the four license exceptions described below
contain restrictions that apply to countries in Country Group E:1 or to
nationals of those countries. This section describes the restrictions
that will no longer apply to Cuba or Cuban nationals as a result of
Cuba's removal from Country Group E:1. This rule makes no change to the
text of the four license exceptions because the removal of the
restrictions results from the removal of Cuba from Country Group E:1
and no changes to the text of the license exceptions are needed.

License Exception Servicing and Replacement of Parts and Equipment
(RPL)

    The removal of Cuba from Country Group E:1 implicates only
paragraph (a) of License Exception Servicing and Replacement of Parts
and Equipment (RPL) in Sec.  740.10 because only paragraph (a), which
authorizes export and reexport of one-for-one replacement parts for
items previously lawfully exported, is authorized for Cuba in Sec.
746.2 of the EAR. Since Cuba is no longer in Country Group E:1, the
following exclusions to License Exception RPL, paragraph (a) no longer
apply to Cuba: paragraph (a)(3)(iv), which excludes parts, components,
accessories, or attachments to repair ``aircraft'' or commodities
controlled for national security (NS) reasons; paragraph (a)(3)(v),
which excludes parts, components, accessories, or attachments to repair
explosives detection equipment classified under Export Control
Classification Number (ECCN) 2A983 or related software classified under
ECCN 2D983; and paragraph (a)(3)(vi) which excludes parts, components,
accessories, or attachments to repair concealed object detection
equipment classified under ECCN 2A984 or related software classified
under ECCN 2D984.

License Exception Governments, International Organizations,
International Inspections Under the Chemical Weapons Convention, and
the International Space Station (GOV)

    Since Cuba is no longer in Country Group E:1, the following
restrictions in License Exception GOV (Sec.  740.11) no longer apply to
Cuban nationals: Paragraph (a)(2)(iv), which restricts physical or
computational access by Country Group E:1 nationals to certain
computers for authorized international safeguard use in connection with
activities of the International Atomic Energy Agency and the European
Atomic Energy Community; paragraph (d)(4), which restricts physical or
computational access by Country Group E:1 nationals to certain
computers for authorized international inspection and verification use
in connection with the activities of the Organization for the
Prohibition of Chemical Weapons; and paragraph (e)(7)(i), which
precludes export, reexport or transfer (in-country) to Country Group
E:1 nationals of items used to support the International Space Station.
Additionally, paragraph (e)(8)(iii), which precludes return of parts
for the International Space Station to destinations in Country Group
E:1, no longer applies to Cuba.

License Exception Baggage (BAG)

    Since Cuba is no longer in Country Group E:1, Sec.  740.14(f)(1),
which authorizes certain exports and reexports of encryption
commodities and software subject to Encryption Items (EI) controls on
the CCL by United States citizens and permanent resident aliens to
destinations other than Country Group E:1, and Sec.  740.14(f)(2),
which authorizes such exports and reexports by individuals other than
nationals of a country in Country Group E:1, no longer apply to Cuba or
Cuban nationals. Additionally, Sec.  740.14(g), which authorizes
certain exports and reexports of technology by U.S. persons, but
excludes in paragraph (g)(4) exports and reexports of encryption
technology controlled in ECCN 5E002 to destinations in Country Group
E:1, no longer applies to Cuba.

License Exception Aircraft, Vessels and Spacecraft (AVS)

    The removal of Cuba from Country Group E:1 implicates only
paragraph (a) of License Exception Aircraft, Vessels and Spacecraft
(AVS) in Sec.  740.15 because only paragraph (a), which authorizes
aircraft on temporary

sojourn, is authorized for Cuba in Sec.  746.2 of the EAR. Since Cuba
is no longer in Country Group E:1, Cuba is no longer subject to the
following restrictions:
     Paragraph (a)(1)(i), which prohibits use of AVS for
foreign registered aircraft that were transferred to a national of a
country in Country Group E:1 while in the United States;
     Paragraph (a)(1)(ii), which prohibits use of AVS for
foreign registered aircraft that are departing the United States for
purpose of transfer to a national of a country in Country Group E:1;
     Paragraph (a)(2)(ii), which prohibits use of AVS for U.S.
registered aircraft that are not operating under an Air Carrier
Operating Certificate, Commercial Operating Certificate or Air Taxi
Operating Certificate from using AVS for temporary sojourns to a
country in Country Group E:1;
     Paragraph (a)(3)(iv), which prohibits principal
maintenance in Country Group E:1 or right to control the principal
place of maintenance by a national of a country in Country Group E:1;
     Paragraph (a)(3)(v), which prohibits location of spares in
a destination in Country Group E:1;
     Paragraph (a)(3)(vi), which prohibits changing the place
of registration to a destination in Country Group E:1;
     Paragraph (a)(3)(vii), which prohibits transfer of
technology to a national of a country in Country Group E:1;
     Paragraph (a)(3)(viii), which prohibits aircraft bearing
livery, colors or logos of a national of a country in Country Group
E:1; and
     Paragraph (a)(3)(ix), which prohibits flying under a
flight number issued to a national of a country in Country Group E:1.

V. Provisions Being Amended To Retain Existing Cuba-Related
Requirements

    Although Cuba is removed from Country Group E:1, Cuba is still
subject to a comprehensive embargo and, as specified in Sec.  746.2(a)
of the EAR, a license is still required to export or reexport to Cuba
any item subject to the EAR unless authorized by a license exception.
This rule makes the changes described below to retain the applicability
of certain provisions and license conditions to Cuba, consistent with
the embargo, that would otherwise cease as a result of Cuba's removal
from Country Group E:1. While Cuba was in Country Group E:1, a separate
reference to Country Group E:2 would have had no effect on exports or
reexports to Cuba. With the removal of Cuba from Country Group E:1, it
is necessary to explicitly link these provisions and conditions to the
embargo.

Written Assurance for License Exception Technology and Software Under
Restriction (TSR)

    Before an exporter or reexporter is able to use License Exception
Technology and Software under Restriction (TSR) in Sec.  740.6 of the
EAR to export or reexport software or technology controlled for
national security reasons, the exporter or reexporter must obtain a
written assurance from the consignee that the software or technology
transferred and its direct product will not be sent to destinations in
Country Group D:1 or E:1 or released to nationals thereof. This rule
retains that restriction with respect to Cuba by adding Country Group
E:2 to those written assurance requirements. The need for a written
assurance is appropriate for countries in Country Groups E:1 and E:2.
However, until the removal of Cuba from Country Group E:1, listing both
country groups would have been redundant.
    Note that License Exception TSR does not authorize exports or
reexports to Cuba because it is not specified in Sec.  746.2(a)(1) of
the EAR and because, by its terms, License Exception TSR is available
only for destinations in Country Group B, which does not include Cuba.

Supplement No. 2 to Part 748--Unique Application and Submission
Requirements

    Supplement No. 2 to Part 748 of the EAR describes information
required to be included in license applications for certain specific
situations. Paragraph (i)(2)(x) requires that technology intended to
accompany any shipment to destinations in Country Group D:1 or E:1 be
described in the application. Paragraph (o)(3)(i) requires applicants
for licenses to export or reexport national security controlled
technology to obtain a written assurance against transfer to
destinations in Country Groups D:1 or E:1. This rule adds Country Group
E:2 to both paragraphs to continue both requirements with respect to
Cuba.

Export Clearance Requirements

    Part 758 of the EAR describes certain export clearance
requirements. Section 758.1(b)(1) makes the $2,500 threshold below
which most exports need not be filed in the Automated Export System
(AES) inapplicable for exports to Country Group E:1 by requiring such
filing for exports to Country Group E:1 regardless of value. This rule
retains that requirement for exports to Cuba by adding Country Group
E:2 to Sec.  758.1(b)(1).
    Section 758.2(b)(3) makes export to Country Group E:1 grounds for
rejecting applications for post-departure filing in AES (i.e.,
authorization to file after the exporting carrier departs the port of
export). This rule retains export to Cuba as a ground for rejection by
adding Country Group E:2 to Sec.  758.2(b)(3).

License Condition General Order

    Supplement No. 1 to Part 736 of the EAR contains certain general
orders. This rule adds General Order No. 3, which was reserved, to
continue all restrictions on transactions with Cuba or Cuban nationals,
by reference to Country Group E:1, that are contained in licenses
issued prior to July 22, 2015. Certain licenses issued by BIS contain
conditions that restrict the export, reexport, or transfer (in-country)
to State Sponsors of Terrorism and countries subject to unilateral
embargo by reference to Country Group E:1. Many of those restrictions
were intended to apply to Cuba, not only as a State Sponsor of
Terrorism but also as a country subject to unilateral embargo. However,
BIS did not always list both Country Groups E:1 and E:2 in license
conditions because, at the time, doing so would have been redundant.
This general order applies those conditions to Country Groups E:1 and
E:2. Licensees who seek authorization for transactions that are
affected by General Order No. 3, may submit license applications that
refer to General Order No. 3 and explain the reason for the request in
Block 24 of the application. All license applications involving Cuba
are reviewed pursuant to the licensing policy in Sec.  746.2(b) of the
EAR.

ECCN 4A003

    This rule adds a reference to Country Group E:2 to the note that
immediately follows the control table in ECCN 4A003. That note states
that except for destinations in Country Group E:1, no license is
required for computers with an Adjusted Peak Performance not exceeding
8.0 weighted teraFLOPS. The addition of Country Group E:2 retains
Cuba's status as a destination for which a license is required.

Export Administration Act

    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 amended by Executive Order 13637 of March
8, 2013, 78 FR 16129 (March 13, 2013), and as extended by the Notice of
August

7, 2014, 79 FR 46959 (August 11, 2014), has continued the Export
Administration Regulations in effect under the International Emergency
Economic Powers Act. BIS continues to carry out the provisions of the
Export Administration Act, as appropriate and to the extent permitted
by law, pursuant to Executive Order 13222 as amended by Executive Order
13637.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has been designated a ``significant regulatory
action,'' although not economically significant, under section 3(f) of
Executive Order 12866. Accordingly, the rule has been reviewed by the
Office of Management and Budget (OMB).
    2. Notwithstanding any other provision of law, no person is
required to respond to, nor shall any person 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 rule
involves a collection of information approved under OMB control number
0694-0088--Simplified Network Application Processing+ System (SNAP+)
and the Multipurpose Export License Application, which are the methods
for submitting all license applications, commodity classification
requests and similar requests to BIS. The estimated annual total burden
of all of those submissions is 31,833 hours. BIS believes that this
rule will have no material impact on that burden. To the extent that it
has any impact, this rule is likely to reduce the burden for two
reasons. First, this rule might reduce the burden because it makes some
transactions, primarily temporary sojourns in Cuba of general aviation
aircraft, which would otherwise require a license, eligible for a
license exception. Second, because this rule raises the percentage of
U.S.-origin content that a foreign-made item must have before its
export from abroad to Cuba becomes subject to the EAR, it reduces the
number of foreign-made items that will need a license from BIS to be
exported from abroad to Cuba.
    Send comments regarding this burden estimate or any other aspect of
this collection of information, including suggestions for reducing the
burden, to Jasmeet K. Seehra, Office of Management and Budget, by email
at<EMAIL_ADDRESS>or by fax to<PHONE_NUMBER> and to William Arvin
at<EMAIL_ADDRESS>    3. This rule does not contain policies with Federalism implications
as that term is defined under 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)). This rule is a part of
the implementation of the rescission of Cuba's designation as a State
Sponsor of Terrorism, which became effective on May 29, 2015. Delay in
implementing this rule to obtain public comment would undermine the
foreign policy objectives that the rule is intended to implement.
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 under 5 U.S.C. 553, or by any
other law, the requirements of the Regulatory Flexibility Act (5 U.S.C.
601 et seq.) are not applicable.

List of Subjects

15 CFR Part 734

    Administrative practice and procedure, Exports, Inventions and
patents, Research, Science and technology.

15 CFR Parts 736 and 772

    Exports.

15 CFR Parts 740, 748, 750, and 758

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

15 CFR Part 742

    Exports, Terrorism.

15 CFR Parts 746 and 774

    Exports, Reporting and recordkeeping requirements.

    Accordingly, parts 734, 736, 740, 742, 746, 748, 750, 758, 772, and
774 of the Export Administration Regulations (15 CFR parts 730-774) are
amended as follows:

PART 734--[AMENDED]

0
1. The authority citation for 15 CFR part 734 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13020, 61
FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 13026, 61 FR 58767, 3 CFR,
1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p.
783; E.O. 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013);
Notice of August 7, 2014, 79 FR 46959 (August 11, 2014); Notice of
November 7, 2014, 79 FR 67035 (November 12, 2014).

0
2. Section 734.4 is amended by revising paragraph (a)(6)(ii) to read as
follows:

Sec.  734.4  De minimis U.S. content.

    (a) * * *
    (6) * * *
    (ii) There is no de minimis level for foreign-made items that
incorporate U.S.-origin 9x515 or ``600 series'' .y items when destined
for a country listed in Country Group E:1 or E:2 of Supplement No. 1 to
part 740 of the EAR or for the People's Republic of China (PRC).
* * * * *

PART 736--[AMENDED]

0
3. The authority citation for 15 CFR part 736 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 2151 note; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p.
950; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 13026,
61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3
CFR, 2001 Comp., p. 783; E.O. 13338, 69 FR 26751, 3 CFR, 2004 Comp.,
p. 168; Notice of August 7, 2014, 79 FR 46959 (August 11, 2014);
Notice of November 7, 2014, 79 FR 67035 (November 12, 2014); Notice
of May 6, 2015, 80 FR 26815 (May 8, 2015).
    (6) * * *

0
4. Section 736.2 is amended by revising paragraphs (b)(3)(i) and (iii)
to read as follows:

Sec.  736.2  General prohibitions and determination of applicability.

* * * * *
    (b) * * *
    (3) General Prohibition Three--Reexport and export from abroad of
the foreign-produced direct product of U.S. technology and software
(Foreign-Produced Direct Product Reexports)--(i) Country scope of
prohibition. You may not, without a license or license exception,
reexport any item subject to the scope of this General Prohibition

Three to a destination in Country Group D:1, E:1, or E:2 (See
Supplement No.1 to part 740 of the EAR). Additionally, you may not,
without a license or license exception, reexport or export from abroad
any ECCN 0A919 commodities subject to the scope of this General
Prohibition Three to a destination in Country Group D:1, D:3, D:4, D:5,
E:1, or E:2.
* * * * *
    (iii) Country scope of prohibition for 9x515 or ``600 series''
items. You may not, except as provided in paragraphs (b)(3)(v) or (vi)
of this section, reexport or export from abroad without a license any
``600 series'' item subject to the scope of this General Prohibition
Three to a destination in Country Groups D:1, D:3, D:4, D:5, E:1, or
E:2 (see Supplement No. 1 to part 740 of the EAR). You may not, except
as provided in paragraphs (b)(3)(v) or (vi) of this section, reexport
or export from abroad without a license any 9x515 item subject to the
scope of this General Prohibition Three to a destination in Country
Groups D:5, E:1, or E:2 (see Supplement No. 1 to part 740 of the EAR).
* * * * *

0
5. Supplement No. 1 to part 736 is amended by revising the heading and
paragraph (c) to read as follows:

Supplement No. 1 to Part 736--General Orders

* * * * *
    (c) General Order No. 3:
    General Order No. 3 of July 22, 2015. Certain licenses issued by
BIS prior to July 22, 2015 contain conditions that restrict the export,
reexport, or transfer (in-country) to or within Country Group E:1 as
specified in Supplement No. 1 to part 740 of the EAR. At the time those
license were issued, Cuba was in Country Group E:1. Many of those
restrictions were intended to apply to Cuba, not only as a State
Sponsor of Terrorism but also as a country subject to unilateral
embargo. However, BIS did not always list both Country Groups E:1 and
E:2 in license conditions because, at the time, doing so would have
been redundant. However, with the rescission of Cuba's designation as a
State Sponsor of Terrorism and resultant removal from Country Group
E:1, continuing those conditions with respect to Cuba is consistent
with the embargo. Accordingly, all conditions that apply to Country
Group E:1 on licenses issued prior to July 22, 2015 that are in effect
on that date, are revised to apply to Country Groups E:1 and E:2 as
specified in Supplement No. 1 to part 740 of the EAR. Licensees who
seek authorization for transactions that are affected by this General
Order No. 3 may submit license applications that refer to General Order
No. 3 and explain the reason for the request in Block 24 of the
application. All license applications involving Cuba are reviewed
pursuant to the licensing policy in Sec.  746.2(b) of the EAR. The
request should provide any available information in support of the
argument that the transaction would be consistent with the licensing
policy in Sec.  746.2(b) of the EAR.
* * * * *

PART 740--[AMENDED]

0
6. The authority citation for 15 CFR part 740 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 7201 et seq.; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp.,
p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice
of August 7, 2014, 79 FR 46959 (August 11, 2014).

Sec.  740.6  [Amended]

0
7. Section 740.6 is amended by removing the phrase ``D:1 or E:1''
wherever it appears in paragraphs (a)(1) and (2) and adding in its
place the phrase ``D:1, E:1, or E:2''.

Supplement No. 1 to Part 740 [Amended]

0
8. Supplement No. 1 to part 740 is amended by removing the ``X'' from
the row for Cuba in the E:1 column of the ``Country Group E'' table.

PART 742--[AMENDED]

0
9. The authority citation for 15 CFR part 742 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22
U.S.C. 7210; Sec. 1503, Pub. L. 108-11, 117 Stat. 559; 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. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O.
13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Presidential
Determination 2003-23 of May 7, 2003, 68 FR 26459, May 16, 2003;
Notice of August 7, 2014, 79 FR 46959 (August 11, 2014); Notice of
November 7, 2014, 79 FR 67035 (November 12, 2014).

Sec.  742.1  [Amended]

0
10. Section 742.1 is amended by removing the word ``Cuba'' and the
comma that follows it from each place that it appears in paragraph (d).

Supplement No. 2 to Part 742 [Amended]

0
11. Supplement No. 2 to part 742 is amended by removing the word
``Cuba'' and the comma that follows it from paragraphs (a) and (b)(1).

PART 746--[AMENDED]

0
12. The authority citation for 15 CFR part 746 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 287c; Sec 1503, Pub. L. 108-11, 117 Stat. 559; 22 U.S.C.
6004; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 12854, 58 FR
36587, 3 CFR, 1993 Comp., p. 614; E.O. 12918, 59 FR 28205, 3 CFR,
1994 Comp., p. 899; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p.
783; E.O. 13338, 69 FR 26751, 3 CFR, 2004 Comp., p 168; Presidential
Determination 2003-23 of May 7, 2003, 68 FR 26459, May 16, 2003;
Presidential Determination 2007-7 of December 7, 2006, 72 FR 1899
(January 16, 2007); Notice of August 7, 2014, 79 FR 46959 (August
11, 2014); Notice of May 6, 2015, 80 FR 26815 (May 8, 2015).

0
13. Section 746.2 is amended by:
0
a. Removing paragraph (b)(3);
0
b. Redesignating paragraphs (b)(4), (5), and (6) as paragraphs (b)(3),
(4), and (5), respectively;
0
c. Removing the phrase ``or counter-terrorism'' from the first sentence
of newly designated paragraph (b)(3)(i);
0
d. Removing paragraph (c);
0
e. Redesignating paragraphs (d) and (e) as paragraphs (c) and (d),
respectively; and
0
f. Revising newly designated paragraph (d).
    The revision to read as follows:

Sec.  746.2  Cuba.

* * * * *
    (d) Related controls. OFAC maintains controls on the activities of
persons subject to U.S. jurisdiction, wherever located, involving
transactions with Cuba or any Cuban national, as provided in 31 CFR
part 515. Exporters and reexporters should consult with OFAC for
further guidance on its related controls.

PART 748--[AMENDED]

0
14. The authority citation for 15 CFR part 748 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66
FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 7, 2014, 79 FR
46959 (August 11, 2014).

Supplement No. 2 to Part 748 [Amended]

0
15. Supplement No. 2 to part 748 is amended by removing the phrase
``Country Group D:1 or E:1'' wherever it appears in paragraphs
(i)(2)(x) and (o)(3)(i) and adding in its place the phrase ``Country
Group D:1, E:1, or E:2''.

PART 750--[AMENDED]

0
16. The authority citation for 15 CFR part 750 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
Sec 1503, Pub. L. 108-11, 117 Stat. 559; E.O. 13026, 61 FR 58767, 3
CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp.,
p. 783; E.O. 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013);
Presidential Determination 2003-23 of May 7, 2003, 68 FR 26459, May
16, 2003; Notice of August 7, 2014, 79 FR 46959 (August 11, 2014).

Sec.  750.4  [Amended]

0
17. Section 750.4 is amended by removing the word ``Cuba'' and the
comma immediately following it from paragraph (b)(6)(i).

PART 758--[AMENDED]

0
18. The authority citation for 15 CFR part 758 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August
7, 2014, 79 FR 46959 (August 11, 2014).

Sec.  758.1  [Amended]

0
19. Section 758.1 is amended by adding the phrase ``or E:2''
immediately following the phrase ``Country Group E:1'' in paragraph
(b)(1).

Sec.  758.2  [Amended]

0
20. Section 758.2 is amended by adding the phrase ``or E:2''
immediately following the phrase ``Country Group E:1'' in paragraph
(b)(3).

PART 772--[AMENDED]

0
21. The authority citation for 15 CFR part 772 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August
7, 2014, 79 FR 46959 (August 11, 2014).

Sec.  772.1  [Amended]

0
22. Section 772.1 is amended by removing the word ``Cuba'' and the
comma that follows it from the definition of ``Countries supporting
international terrorism.''

PART 774--[AMENDED]

0
23. The authority citation for 15 CFR part 774 continues to read as
follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et
seq.; 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42
U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C. 1824a; 50 U.S.C. app. 5; 22
U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 CFR,
1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p.
783; Notice of August 7, 2014, 79 FR 46959 (August 11, 2014).

0
24. In supplement No. 1 to part 774 (The Commerce Control List), Export
Control Classification Number (ECCN) 1C350 is amended by revising
second paragraph that follows the License Requirements table to read as
follows:

Supplement No. 1 to Part 774--The Commerce Control List

* * * * *

1C350 Chemicals that may be used as precursors for toxic chemical
agents (see List of Items Controlled).

License Requirements

* * * * *
    AT applies to entire entry. The Commerce Country Chart is not
designed to determine licensing requirements for items controlled for
AT reasons in 1C350. A license is required, for AT reasons, to export
or reexport items controlled by 1C350 to a country in Country Group E:1
of Supplement No. 1 to part 740 of the EAR. (See part 742 of the EAR
for additional information on the AT controls that apply to Iran, North
Korea, Sudan, and Syria. See part 746 of the EAR for additional
information on sanctions that apply to Iran, North Korea, and Syria.)
* * * * *

0
25. In supplement No. 1 to part 774, ECCN 1C355 is amended by revising
the second ``Control(s)'' paragraph to read as follows:

1C355 Chemical Weapons Convention (CWC) Schedule 2 and 3 chemicals and
families of chemicals not controlled by ECCN 1C350 or ``subject to the
ITAR'' (see 22 CFR parts 120 through 130) (see List of Items
Controlled).

License Requirements

* * * * *
    Control(s): * * *
    AT applies to entire entry. The Commerce Country Chart is not
designed to determine licensing requirements for items controlled for
AT reasons in 1C350. A license is required, for AT reasons, to export
or reexport items controlled by 1C350 to a country in Country Group E:1
of Supplement No. 1 to part 740 of the EAR. (See part 742 of the EAR
for additional information on the AT controls that apply to Iran, North
Korea, Sudan, and Syria. See part 746 of the EAR for additional
information on sanctions that apply to Iran, North Korea, and Syria.)
* * * * *

0
26. In supplement No. 1 to part 774, ECCN 1C395 is amended by revising
the third ``Control(s)'' paragraph to read as follows:

1C395 Mixtures and Medical, Analytical, Diagnostic, and Food Testing
Kits Not Controlled by ECCN 1C350, as follows (See List of Items
Controlled).

License Requirements

* * * * *
    Control(s): * * *
    AT applies to entire entry. The Commerce Country Chart is not
designed to determine licensing requirements for items controlled for
AT reasons in 1C395. A license is required, for AT reasons, to export
or reexport items controlled by 1C395 to a country in Country Group E:1
of Supplement No. 1 to part 740 of the EAR. (See part 742 of the EAR
for additional information on the AT controls that apply to Iran, North
Korea, Sudan, and Syria. See part 746 of the EAR for additional
information on sanctions that apply to Iran, North Korea, and Syria.)
* * * * *

0
27. In supplement No. 1 to part 774, ECCN 2A994 is amended by revising
the ``Control(s)'' paragraph to read as follows:

2A994 Portable electric generators and ``specially designed'' ``parts''
and ``components.''

* * * * *
Control(s): AT applies to entire entry. A license is required for items
controlled by this entry to Iran and North Korea. The Commerce Country
Chart is not designed to determine licensing requirements for this
entry. See part 746 of the EAR for additional information on Iran. See
Sec.  742.19 of the EAR for additional information on North Korea.
* * * * *

0
28. In supplement No. 1 to part 774, ECCN 2D994 is amended by revising
the ``Control(s)'' paragraph to read as follows:

2D994 ``Software'' ``specially designed'' for the ``development'' or
``production'' of portable electric generators controlled by 2A994.

License Requirements

* * * * *
Control(s): AT applies to entire entry. A license is required for items
controlled by this entry to Iran and North Korea for anti-terrorism
reasons. The Commerce Country Chart is not designed to determine
licensing requirements for this entry. See part 746 of the EAR for
additional information on Iran. See Sec.  742.19 of the EAR for
additional information on North Korea.
* * * * *

0
29. In supplement No. 1 to part 774, ECCN 2E994 is amended by revising
the ``Control(s)'' paragraph to read as follows:

2E994 ``Technology'' for the ``use'' of portable electric generators
controlled by 2A994.

License Requirements

* * * * *
Control(s): AT applies to entire entry. A license is required for items
controlled by this entry to Iran and North Korea for anti-terrorism
reasons. The Commerce Country Chart is not designed to determine
licensing requirements for this entry. See part 746 of the EAR for
additional information on Iran. See Sec.  742.19 of the EAR for
additional information on North Korea.
* * * * *

ECCN 4A001--[Amended]

0
30. In supplement No. 1 to part 774, ECCN 4A003 is amended by adding
the phrase ``or E:2'' immediately following the phrase ``Country Group
E:1'' in the note that immediately follows the License Requirements
table.

    Dated: July 17, 2015.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
[FR Doc. 2015-17981 Filed 7-21-15; 8:45 am]
BILLING CODE 3510-33-P


[Federal Register: June 2, 2008 (Volume 73, Number 106)]
[Notices]
[Page 31543]
[DOCID:fr02jn08-132]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

International Standards on the Transport of Dangerous Goods;
Public Meeting

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
Department of Transportation.

ACTION: Notice of public meeting.

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

SUMMARY: This notice is to advise interested persons that PHMSA will
conduct a public meeting in preparation for the 33rd session of the
United Nation's Sub-Committee of Experts on the Transport of Dangerous
Goods (UNSCOE) to be held June 30-July 9, 2008 in Geneva, Switzerland.
In addition, PHMSA is soliciting comments relative to any potential new
work items which may be considered for inclusion in its international
agenda.

DATES: Wednesday, June 18, 2008; 9:30 a.m.-1:30 p.m.

ADDRESSES: The meeting will be held at the new DOT Headquarters, West
Building, Oklahoma City Conference Room, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.
    Conference Call Capability Information: Call-in capability will be
provided for this meeting. To participate by telephone, dial 1 (888)
395-1810 and enter participant passcode 63672. During the call, please
press *6 to mute/unmute your individual line. This will ensure
participants are not subjected to any background noise from individual
lines.

FOR FURTHER INFORMATION CONTACT: Mr. Duane Pfund, Director, Office of
International Standards, Office of Hazardous Materials Safety,
Department of Transportation, Washington, DC 20590;<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The primary purpose of this meeting will be
to prepare for the 33rd session of the UNSCOE and to discuss draft U.S.
positions on UNSCOE proposals. The 33rd session of the UNSCOE is the
third meeting in the current biennium cycle. The UNSCOE will consider
proposals for the 16th Revised Edition of the United Nations
Recommendations on the Transport of Dangerous Goods Model Regulations
which will come into force in the international regulations from
January 1, 2011. Topics to be covered during the public meetings
include: Transport of limited quantities and consumer commodities,
provisions for training of personnel, use of electronic documentation,
subsidiary labeling for toxic by inhalation liquids, requirements for
cryogenic receptacles, requirements for lithium batteries, fumigated
units and dry ice, harmonization with the IAEA Regulations for the safe
transport of radioactive materials, guiding principles for the
development of the Model Regulations, and various miscellaneous
proposals related to listing, classification, and hazard communication.
    Finally, PHMSA is soliciting comments on how to further enhance
harmonization for international transport of hazardous materials. PHMSA
is developing a five year plan to address international harmonization
and welcomes input on items which stakeholders believe should be
included in this plan.
    The public is invited to attend without prior notification. Due to
the heightened security measures participants are encouraged to arrive
early to allow time for security checks necessary to obtain access to
the building. In lieu of conducting a public meeting after the 33rd
session of the UNSCOE to present the results of the session, PHMSA will
place a copy of the Sub-Committee's report and an updated copy of the
pre-meeting summary document on PHMSA's Hazardous Materials Safety
Homepage at http://hazmat.dot.gov/regs/intl/intstandards.htm.

Documents

    Copies of documents for the UNSCOE meeting and the meeting agenda
may be obtained by downloading them from the United Nations Transport
Division's web site at:http://www.unece.org/trans/main/dgdb/dgsubc/
c32008.html. This site may also be accessed through PHMSA's Hazardous
Materials Safety Web site at http://hazmat.dot.gov/regs/intl/
intstandards.htm. PHMSA' s site provides additional information
regarding the UNSCOE and related matters such as a summary of decisions
taken at previous sessions of the UNSCOE.

    Issued in Washington, DC, on May 22, 2008.
Theodore L. Willke,
Associate Administrator for Hazardous Materials Safety.
 [FR Doc. E8-12060 Filed 5-30-08; 8:45 am]

BILLING CODE 4910-60-M


[Federal Register Volume 85, Number 62 (Tuesday, March 31, 2020)]
[Notices]
[Pages 17898-17899]
[FR Doc No: 2020-06630]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2020-0097]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625-0087

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting an extension of
its approval for the following collection of information: 1625-0087,
U.S. Coast Guard International Ice Patrol (IIP) Customer Survey;
without change. Our ICR describes the information we seek to collect
from the public. Before submitting this ICR to OIRA, the Coast Guard is
inviting comments as described below.

DATES: Comments must reach the Coast Guard on or before June 1, 2020.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2020-0097] to the Coast Guard using the Federal
eRulemaking Portal at https://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.
    A copy of the ICR is available through the docket on the internet
at https://www.regulations.gov. Additionally, copies are available
from: Commandant (CG-6P), Attn: Paperwork Reduction Act Manager, U.S.
Coast Guard, 2703 Martin Luther King Jr. Ave. SE, STOP 7710,
Washington, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: Mr. A.L. Craig, Office of Privacy
Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>, for questions
on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. Consistent with
the requirements of Executive Order 13771, Reducing Regulation and
Controlling Regulatory Costs, and Executive Order 13777, Enforcing the
Regulatory Reform Agenda, the Coast Guard is also requesting comments
on the extent to which this request for information could be modified
to reduce the burden on respondents.
    In response to your comments, we may revise this ICR or decide not
to seek an extension of approval for the Collection. We will consider
all comments and material received during the comment period.

    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2020-0097], and
must be received by June 1, 2020.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at https://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to https://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, 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).

Information Collection Request

    Title: U.S. Coast Guard International Ice Patrol (IIP) Customer
Survey.
    OMB Control Number: 1625-0087.
    Summary: This information collection provides feedback on the
processes of delivery and products distributed to the mariner by the
International Ice Patrol.
    Need: In accordance with Executive Order 12862, the U.S. Coast
Guard is directed to conduct surveys (both qualitative and
quantitative) to determine the kind and quality of services our
customers want and expect, as well as their satisfaction with USCG's
existing services. This survey will be limited to data collections that
solicit strictly voluntary opinions and will not collect information
that is required or regulated.
    Forms: CG-16700, North American Ice Service (NAIS) Customer Survey.
    Respondents: CG-16700, North American Ice Service (NAIS) Customer
Survey.
    Frequency: Annually.
    Hour Burden Estimate: The burden is estimated to be 120 hours.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. chapter
35, as amended.

    Dated: March 25, 2020.
Kathleen Claffie,
Chief, Office of Privacy Management, U.S. Coast Guard.
[FR Doc. 2020-06630 Filed 3-30-20; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: February 11, 2009 (Volume 74, Number 27)]
[Notices]
[Page 6925]
[DOCID:fr11fe09-93]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59361, File No. 4-518]

Joint Industry Plan; Order Approving Amendment To Add the BATS
Exchange, Inc. as Participant to National Market System Plan
Establishing Procedures Under Rule 605 of Regulation NMS

February 5, 2009.

I. Introduction

    On September 19, 2008, the BATS Exchange, Inc. (``BATS'' or ``BATS
Exchange'') submitted to the Securities and Exchange Commission
(``SEC'' or ``Commission'') in accordance with Section 11A of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 608 of
Regulation NMS,\2\ a proposed amendment to the national market system
plan establishing procedures under Rule 605 of Regulation NMS (``Joint-
SRO Plan'' or ``Plan'').\3\ Under the proposed amendment, BATS would be
added as a participant to the Joint-SRO Plan. Notice of filing and an
order granting temporary effectiveness of the proposal through February
5, 2009 were published in the Federal Register on October 8, 2008.\4\
The Commission did not receive any comments on the proposed amendment.
This order approves the amendment on a permanent basis.
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    \1\ 15 U.S.C. 78k-1.
    \2\ 17 CFR 242.608.
    \3\ 17 CFR 242.605. On April 12, 2001, the Commission approved a
national market system plan for the purpose of establishing
procedures for market centers to follow in making their monthly
reports available to the public under Rule 11Ac1-5 under the Act (n/
k/a Rule 605 of Regulation NMS). See Securities Exchange Act Release
No. 44177 (April 12, 2001), 66 FR 19814 (April 17, 2001).
    \4\ See Securities Exchange Act Release No. 58695 (September 30,
2008), 73 FR 58993.
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II. Discussion

    The Joint-SRO Plan establishes procedures for market centers to
follow in making their monthly reports required pursuant to Rule 605 of
Regulation NMS, available to the public in a uniform, readily
accessible, and usable electronic format. The current participants to
the Joint-SRO Plan are the American Stock Exchange LLC, Boston Stock
Exchange, Inc., Chicago Board Options Exchange, Incorporated, Chicago
Stock Exchange, Inc., Cincinnati Stock Exchange, Inc. (n/k/a National
Stock Exchange SM), International Securities Exchange LLC,
The NASDAQ Stock Market LLC, National Association of Securities
Dealers, Inc., New York Stock Exchange, Inc. (n/k/a New York Stock
Exchange LLC), Pacific Exchange, Inc. (n/k/a NYSE Arca, Inc.), and
Philadelphia Stock Exchange, Inc. The proposed amendment would add BATS
as a participant to the Joint-SRO Plan.
    Section III(b) of the Joint-SRO Plan provides that a national
securities exchange or national securities association may become a
party to the Plan by: (i) Executing a copy of the Plan, as then in
effect (with the only changes being the addition of the new
participant's name in Section II(a) of the Plan and the new
participant's single-digit code in Section VI(a)(1) of the Plan) and
(ii) submitting such executed plan to the Commission for approval. BATS
submitted a signed copy of the Joint-SRO Plan to the Commission in
accordance with the procedures set forth in the Plan regarding new
participants.
    The Commission finds that the amendment to the Joint-SRO Plan is
consistent with the requirements of the Act and the rules and
regulations thereunder. Specifically, the Commission finds that the
proposed amendment is consistent with the requirements of Section 11A
of the Act,\5\ and Rule 608 of Regulation NMS.\6\ The Plan established
appropriate procedures for market centers to follow in making their
monthly reports required pursuant to Rule 605 of Regulation NMS
available to the public in a uniform, readily accessible, and usable
electronic format. The amendment to include BATS as a participant in
the Joint-SRO Plan should contribute to the maintenance of fair and
orderly markets and remove impediments to and perfect the mechanisms of
a national market system by facilitating the uniform public disclosure
of order execution information by all market centers. The Commission
believes that it is necessary and appropriate in the public interest,
for the maintenance of fair and orderly markets, to remove impediments
to, and perfect mechanisms of, a national market system to allow BATS
to become a participant in the Joint-SRO Plan. The Commission finds,
therefore, that approving the amendment to the Joint-SRO Plan is
appropriate and consistent with Section 11A of the Act.\7\
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    \5\ 15 U.S.C. 78k-1.
    \6\ 17 CFR 242.608.
    \7\ 15 U.S.C. 78k-1.
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III. Conclusion

    It is therefore ordered, pursuant to Section 11A(a)(3)(B) of the
Act \8\ and Rule 608 of Regulation NMS,\9\ that the amendment to the
Joint-SRO Plan to add BATS as a participant is approved and BATS is
authorized to act jointly with the other participants to the Joint-SRO
Plan in planning, developing, operating, or regulating the Plan as a
means of facilitating a national market system.
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    \8\ 15 U.S.C. 78k-1(a)(3)(B).
    \9\ 17 CFR 242.608.
    \10\ 17 CFR 200.30-3(a)(29).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-2857 Filed 2-10-09; 8:45 am]

BILLING CODE 8011-01-P