[Federal Register Volume 79, Number 225 (Friday, November 21, 2014)]
[Notices]
[Pages 69560-69561]
[FR Doc No: 2014-27427]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Actions on Special Permit Applications

AGENCY: Office of Hazardous Materials Safety, Pipeline and Hazardous
Materials Safety Administration (PHMSA), DOT.

ACTION: Notice of actions on special permit applications.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR part 107,
Subpart B), notice is hereby given of the actions on special permits
applications in (October to October 2014). The mode of transportation
involved are identified by a number in the ``Nature of Application''
portion of the table below as follows: 1--Motor vehicle, 2--Rail
freight, 3--Cargo vessel, 4--Cargo aircraft only, 5--Passenger-carrying
aircraft. Application numbers prefixed by the letters EE represent
applications for Emergency Special Permits. It should be noted that
some of the sections cited were those in effect at the time certain
special permits were issued.

    Issued in Washington, DC, on November 13, 2014.
Donald Burger,
Chief, Special Permits and Approvals Branch.

----------------------------------------------------------------------------------------------------------------
                                                                                Nature of special permit
           S.P. No.                    Applicant               Regulation(s)                  thereof
----------------------------------------------------------------------------------------------------------------
                                       Modification Special Permit Granted
----------------------------------------------------------------------------------------------------------------
16266-M......................  Stericycle, Inc., Lake    49 CFR 173.196(a).......  To modify the special permit
                                Forest.                                             to authorize an additional
                                                                                packaging configuration.
11770-M......................  Gas Cylinder              49 CFR 173.302a, and      To modify the special permit
                                Technologies, Inc.,       173.304a.                 to authorize cargo and
                                Lakeshore, Ontario.                                 passenger aircraft as an
                                                                                additional mode of
                                                                                transportation.
----------------------------------------------------------------------------------------------------------------
                                           New Special Permit Granted
----------------------------------------------------------------------------------------------------------------
16144-N......................  Stage FX, Inc.,           49 CFR 173.56(b) and      To authorize the
                                Columbus, MT.             172.320.                  transportation in commerce
                                                                                of certain Class 1 materials
                                                                                without EX classification
                                                                                for approximately 15 miles
                                                                                by motor vehicle. (mode 1).
16174-N......................  Goal Zero, Bluffdale, UT  49 CFR 173.185(a)(1)....  To authorize the
                                                                                transportation in commerce
                                                                                of certain lithium batteries
                                                                                that do not have the
                                                                                original UN test
                                                                                certifications by motor
                                                                                vehicle. (mode 1).
----------------------------------------------------------------------------------------------------------------

                                        Emergency Special Permit Granted
----------------------------------------------------------------------------------------------------------------
16263-N one-.................  Kalitta Air, LLC,         49 CFR 172.101 Column     To authorize the time
                                Ypsilanti, MI.            (9B), 172.204(c)(3),      transportation in commerce
                                                          173.27(b)(2) and (3)      of certain explosives that
                                                          and 175.30(a)(1).         are forbidden for
                                                                                transportation by cargo only
                                                                                aircraft. (mode 4).
16266-N......................  Stericycle, Inc., Lake    49 CFR 173.196(a).......  To authorize the
                                Forest, IL.                                         transportation in commerce
                                                                                of Ebola contaminated waste
                                                                                for disposal or
                                                                                incineration. (mode 1).
16279-N......................  Veolia ES Technical       49 CFR 173.196(a) and     To authorize the
                                Solutions, L.L.C.,        (b).                      transportation in commerce
                                Flanders, NJ.                                       of ebola contaminated waste
                                                                                in alternative packaging.
                                                                                (mode 1).
16278-N......................  Stericycle, Inc., Lake    49 CFR 173.196(a).......  To authorize the
                                Forest, IL.                                         transportation in commerce
                                                                                of Ebola contaminated
                                                                                medical waste in alternative
                                                                                packaging for disposal or
                                                                                incineration. (mode 1).
----------------------------------------------------------------------------------------------------------------
                                          New Special Permit Withdrawn
----------------------------------------------------------------------------------------------------------------
16242-N......................  E.I. duPont de Nemours    49 CFR 173.32(a)(2).....  To authorize the
                                and Company,                                        transportation in commerce
                                Wilmington, DE.                                     of two portable tanks that
                                                                                have been filled after the
                                                                                prescribed periodic
                                                                                inspection was due. (mode
                                                                                1).
16296-N......................  Southern California       49 CFR 173.56...........  To authorize the
                                Aviation, Victorville,                              transportation in commerce
                                CA.                                                 of chemical oxygen
                                                                                generators. (modes 1, 4).
16126-N......................  Raytheon Missile          49 CFR 173.62...........  To authorize the
                                Systems, Tucson, AZ.                                transportation in commerce
                                                                                of certain Cartridges, power
                                                                                device in UN5OB large
                                                                                packaging. (mode 1).
----------------------------------------------------------------------------------------------------------------
                                       Emergency Special Permit Withdrawn
----------------------------------------------------------------------------------------------------------------
16282-N......................  Progressive               49 CFR 173.196(a).......  To authorize the
                                Environmental Services,                             transportation in commerce
                                Inc., d-b-a, SWS                                    of certain Ebola
                                Environmental Services,                             contaminated medical waste
                                Panama City Beach, FL.                              for autoclaving or
                                                                                incineration. (mode 1).
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2014-27427 Filed 11-20-14; 8:45 am]
BILLING CODE 4910-60-M


[Federal Register Volume 86, Number 4 (Thursday, January 7, 2021)]
[Rules and Regulations]
[Pages 944-949]
[FR Doc No: 2020-27754]

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

DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 742 and 774

[Docket No.<PHONE_NUMBER>]
RIN 0694-AI09

Commerce Control List: Clarifications to the Scope of Export
Control Classification Number 1C991 To Reflect Decisions Adopted at the
June 2019 Australia Group Plenary Meeting

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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

SUMMARY: The Bureau of Industry and Security (BIS) publishes this final
rule to amend the Export Administration Regulations (EAR) to clarify
the scope of the export controls that apply to certain vaccines and
medical products, consistent with the release (i.e., exclusion) notes
contained in the Australia Group (AG) ``Human and Animal Pathogens and
Toxins for Export Control'' common control list.

DATES: This rule is effective January 7, 2021.

FOR FURTHER INFORMATION CONTACT: Dr. Kimberly Orr, Chemical and
Biological Controls Division, Office of Nonproliferation and Treaty
Compliance, Bureau of Industry and Security, Telephone:<PHONE_NUMBER>,
Email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Bureau of Industry and Security (BIS) is
amending the Export Administration Regulations (EAR) to clarify the
scope of the export controls that apply to certain vaccines, consistent
with the vaccine release (i.e., exclusion) note contained in the
Australia Group (AG) ``List of Human and Animal Pathogens and Toxins
for Export Control'' common control list, as updated by a decision made
at the AG Plenary meeting held in Paris, France, in June 2019. The AG
is a multilateral forum consisting of 42 participating countries and
the European Union that maintain export controls on a list of
chemicals, biological agents, and related equipment and technology that
could be used in a chemical or biological weapons program. The AG
periodically reviews items on its control list to enhance the
effectiveness of participating governments' national controls and to
achieve greater harmonization among these controls.
    The AG specifically excludes certain vaccines from control under
its ``List of Human and Animal Pathogens and Toxins for Export
Control'' and the associated Warning List. However, prior to the June
2019 Plenary changes to this AG common control list, it was not clear
if the release note therein applied not only to vaccines containing
those human and animal pathogens and toxins identified on the list, but
also to vaccines containing the genetic elements and genetically
modified organisms identified therein. Recent changes to this AG common
control list, based in part on a decision made at the June 2019 Plenary
meeting, clarify that this release note applies to vaccines containing
the genetic elements and genetically modified organisms identified on
this list, as well as vaccines containing the viruses, bacteria, and
toxins identified on this list.
    Specifically, this rule amends Export Control Classification Number
(ECCN) 1C991 on the Commerce Control List (CCL) to indicate that it
includes vaccines containing, or designed for use against, any of the
items identified in ECCN 1C351, 1C353 or 1C354. Prior to the effective
date of this final rule, ECCN 1C991 indicated that it controlled
vaccines ``against'' such items, but was not specific about whether all
vaccines ``containing'' such items were controlled, irrespective of
whether the vaccines were designed for use ``against'' such items.
    This rule also expands the scope of medical products controlled
under ECCN 1C991 to include those containing genetically modified
organisms and genetic elements described in ECCN 1C353.a.3. In
addition, this rule clarifies the definition of `immunotoxin' that
appears in ECCN 1C351 and ECCN 1C991 and removes the definition of
`subunit' from ECCN 1C351.
    Finally, this rule renumbers ECCN 1C991.c and .d by listing medical
products that are subject to chemical/biological (CB) controls, as well
as anti-terrorism (AT) controls, under ECCN 1C991.c and listing medical
products that are subject only to AT controls under ECCN 1C991.d. A
conforming amendment is made to Sec.  742.2(a)(3) of the EAR to reflect
this change in paragraph sequencing.

ECCN 1C991 (Vaccines, Immunotoxins, Medical Products, Diagnostic and
Food Testing Kits)

    This final rule amends ECCN 1C991 on the Commerce Control List
(CCL) (Supplement No. 1 to part 774 of the EAR) to make the description
of the vaccines controlled by this ECCN more closely reflect the scope
of the vaccine release note contained in the AG ``List of Human and
Animal Pathogens and Toxins for Export Control.'' ECCN 1C991 does not
control any of the human and animal pathogens and toxins or genetic
elements and genetically modified organisms identified on this AG list;
however, it does control vaccines, immunotoxins, medical products, and
diagnostic and food testing kits that contain certain of these AG-
listed items.
    The amendments contained in this final rule are intended to clarify
the scope of the vaccine controls described in ECCN 1C991. Prior to the
effective date of this final rule, the control text for vaccines
described in ECCN 1C991.a indicated that this ECCN controlled
``vaccines against items controlled by ECCN 1C351, 1C353 or 1C354.''
The use of the term ``against'' in the control text created some
uncertainty concerning the extent to which ECCN 1C991.a applied to
vaccines that ``contain'' items controlled by ECCN 1C351, 1C353 or

1C354, but that act against agents (or other disease causing organisms)
that are not identified in any of these ECCNs. This uncertainty caused
some concern among manufacturers and exporters about the correct
classification and licensing policies for such vaccines.
    The clarifications in this rule to the scope of the vaccine
controls in ECCN 1C991.a are also in response to recent scientific and
medical developments. For example, viruses controlled under ECCN 1C351
(e.g., vesicular stomatitis virus, yellow fever virus, and Newcastle
disease virus) are being modified to express surface proteins of other
target organisms or cells for stimulating immune response to the
surface protein, thus acting as vaccines against those targets. These
medical products can be designed for the following purposes: (1)
Vaccination against agents controlled by ECCN 1C351 (e.g., Ebolavirus
or Chikungunya virus); (2) to protect against uncontrolled agents; or
(3) as oncolytic medical products for treating specific cancers
(oncolytic virotherapy is an emerging treatment that uses replication
competent viruses to destroy cancers).
    This final rule addresses industry's concerns and the recent
scientific and medical developments described above by revising ECCN
1C991.a to read as follows: ``Vaccines containing, or designed for use
against, items controlled by ECCN 1C351, 1C353 or 1C354.'' As a result
of this change, ECCN 1C991.a now clearly indicates that it controls all
vaccines that ``contain'' items controlled by ECCN 1C351, 1C353 or
1C354, as well as those vaccines that are designed for use ``against''
these items.
    This rule also amends ECCN 1C991 by expanding the scope of medical
products controlled under this ECCN, consistent with the release (i.e.,
exclusion) note for such products in the ``List of Human and Animal
Pathogens and Toxins for Export Control,'' to include medical products
containing genetically modified organisms or genetic elements
controlled under ECCN 1C353.a.3. In addition, the control text for
medical products in ECCN 1C991 is renumbered by listing medical
products that are subject to chemical/biological (CB) controls, as well
as anti-terrorism (AT) controls, under ECCN 1C991.c and listing medical
products that are subject only to AT controls, under ECCN 1C991.d.
Prior to the effective date of this final rule, the former were listed
under ECCN 1C991.d, while the latter were listed under ECCN 1C991.c.
This change is intended to emphasize the more stringent controls that
apply to the medical products now described in ECCN 1C991.c (i.e., CB
controls, in addition to AT controls) and to clearly indicate that the
CB controls that apply to most of the medical products controlled under
this ECCN do not apply to the medical products now controlled under
ECCN 1C991.d, which are subject only to AT controls (the controls that
apply to items in ECCN 1C991 are described in more detail, below). A
conforming amendment is made to Sec.  742.2(a)(3) of the EAR to reflect
this change in paragraph sequencing.
    This rule also makes a technical correction to the definition of
`medical products' in the ``Related Definitions'' paragraph under the
List of Items Controlled for ECCN 1C991 by adding the parenthetical
phrase ``(or veterinary)'' to the criterion describing pharmaceutical
formulations. The criterion, as corrected, reads as follows: ``(1)
pharmaceutical formulations designed for testing and human (or
veterinary) administration in the treatment of medical conditions.'' In
addition, the definition of `immunotoxins' in the ``Related
Definitions'' paragraph of ECCN 1C351 and ECCN 1C991 is clarified to
read as follows: ``immunotoxins are monoclonal antibodies linked to a
toxin with the intention of destroying a specific target cell while
leaving adjacent cells intact.''
    This rule also adds a Technical Note at the beginning of the
``Items'' paragraph in the List of Items Controlled under ECCN 1C991 to
clarify that, for purposes of the controls described in this ECCN,
`toxins' means those toxins, or their subunits, controlled under ECCN
1C351.d.
    Note that all items controlled by ECCN 1C991, including the
vaccines described in ECCN 1C991.a, require a license for AT reasons to
the destinations indicated under AT Column 1 on the Commerce Country
Chart in Supplement No. 1 to part 738 of the EAR (also see the AT
license requirements described in part 742 of the EAR that apply to
Iran, North Korea, Sudan and Syria). In addition, the medical products
now controlled by ECCN 1C991.c (as renumbered by this rule) require a
license for CB reasons, as well as AT reasons, to the destinations
indicated under CB Column 3 and AT Column 1, respectively, on the
Commerce Country Chart. A license also is required to certain
destinations in accordance with the embargoes and other special
controls described in part 746 of the EAR.

Anticipated Impact of This Final Rule

    Prior to the publication of this final rule, paragraph (a) of ECCN
1C991 included only those vaccines designed to protect against
biological agents controlled under ECCN 1C351, 1C353 or 1C354 on the
CCL. For example, the vaccine for protection against Ebola was
previously (and continues to be) classified for control under ECCN
1C991, because Ebola, itself, is a controlled biological agent. The
Ebola vaccine also contains genetic elements for recombinant vesicular
stomatitis virus (VSV), a controlled virus, and a common vector for
vaccine development.
    However, ECCN 1C991 did not previously include vaccines containing
controlled biological agents that were not also designed to protect
against a controlled agent. Other VSV-based vaccines against EAR99
agents (i.e., agents not controlled on the CCL), such as SARS-CoV-2,
were controlled to all destinations under ECCN 1C353, because they did
not act against a controlled agent as previously required by the ECCN
1C991 vaccine control text.
    This rule amends the vaccine controls in paragraph (a) of ECCN
1C991 to more accurately reflect the scope of the AG release note for
vaccines, which exempts vaccines from control under the AG List of
Human and Animal Pathogens and Toxins. Specifically, the AG release
note exempts from control all vaccines containing one or more of the
biological agents identified on this AG common control list.
    Although certain COVID vaccines are not affected by this rule, the
development of an unknown number of other vaccines, COVID and
otherwise, is expected to be greatly facilitated as a result of these
amendments to the vaccine controls in ECCN 1C991.
    Effective with the publication of this rule, COVID vaccines
containing genetic elements of items controlled by ECCN 1C353 (such as
VSV) are now controlled under ECCN 1C991, instead of ECCN 1C353.
Consequently, instead of requiring a license for export or reexport to
all destinations, a license is required only to a much more limited
number of destinations (i.e., countries of concern for anti-terrorism
(AT) reasons).
    A specific example of the impact of this rule is a VSV-SARS-CoV-2
vaccine, which is a vesicular stomatitis virus modified by adding the
gene for the coronavirus spike protein. Because this vaccine acts
against SARS-CoV-2, which is not controlled under ECCN 1C351, it was
not classified as an ECCN 1C991 vaccine, prior to the publication of
this rule. Instead, it was controlled under ECCN 1C353, in spite of
having received FDA approval and being packaged for patient use,
because it contains genetic elements from VSV (a

controlled virus). Consequently, this vaccine previously required a
license to all destinations. Effective with the publication of this
final rule, this vaccine is now controlled under ECCN 1C991 and
requires a license only to designated countries of concern for AT
reasons.

Saving Clause

    Shipments of items removed from eligibility for export, reexport or
transfer (in-country) under a license exception or without a license
(i.e., under the designator ``NLR'') as a result of this regulatory
action that were on dock for loading, on lighter, laden aboard an
exporting carrier, or en route aboard a carrier to a port of export, on
January 7, 2021, pursuant to actual orders for export, reexport or
transfer (in-country) to a foreign destination, may proceed to that
destination under the previously applicable license exception or
without a license (NLR) so long as they are exported, reexported or
transferred (in-country) before March 8, 2021. Any such items not
actually exported, reexported or transferred (in-country) before
midnight, on March 8, 2021, require a license in accordance with this
regulation.
    ``Deemed'' exports of ``technology'' and ``source code'' removed
from eligibility for export under a license exception or without a
license (under the designator ``NLR'') as a result of this regulatory
action may continue to be made under the previously available license
exception or without a license (NLR) before March 8, 2021. Beginning at
midnight on March 8, 2021, such ``technology'' and ``source code'' may
no longer be released, without a license, to a foreign national subject
to the ``deemed'' export controls in the EAR when a license would be
required to the home country of the foreign national in accordance with
this regulation.

Export Control Reform Act of 2018

    The Export Control Reform Act of 2018 (ECRA), as amended, codified
at 50 U.S.C. 4801-4852, serves as the authority under which BIS issues
this rule.

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 and of reducing costs, harmonizing rules, and 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.
    The cost-benefit analysis required pursuant to Executive Orders
13563 and 12866, as described below, indicates that this rule is
intended to improve national security as its primary direct benefit and
that this benefit significantly outweighs the costs of this rule.
Specifically, implementation, in a timely manner, of the Australia
Group (AG) agreements described herein will enhance the national
security of the United States by reducing the risk that international
trade involving dual-use chemical and biological items would contribute
to the proliferation of chemical and biological weapons of mass
destruction. The principal objective of AG participating countries is
to use licensing measures to ensure that exports of certain chemicals,
biological agents, and dual-use chemical and biological manufacturing
facilities and equipment, do not contribute to the proliferation of
chemical and biological weapons of mass destruction, which has been
identified as a threat to domestic and international peace and
security. The AG achieves this objective by harmonizing participating
countries' national export licensing measures. These controls are
essential, given that the international chemical and biotechnology
industries are a target for proliferators as a source of materials for
chemical and biological weapons programs.
    In calculating what costs (if any) will be imposed by this rule,
BIS estimates that 10 fewer license applications will need to be
submitted to BIS, annually, as a result of the implementation of the
amendments described in this rule (see Rulemaking Requirements #2,
below). By applying the cost-benefit analysis required under Executive
Orders 13563 and 12866 to this rule, as described herein, BIS has
determined that the benefits of this rule (i.e., the enhancement of our
national security through the fulfillment our multilateral obligations
as an AG participating country, together with the anticipated reduction
in the number of license applications that would have to be submitted
to export certain items affected by this rule) significantly outweigh
any potential costs (i.e., the incidental costs to exporters of
adjusting their export control procedures for certain items affected by
this rule). Furthermore, consistent with the stated purpose of the
amendments to ECCN 1C991 (i.e., to enhance the national security of the
United States), this rule meets the requirements set forth in the April
5, 2017, Office of Management and Budget (OMB) guidance implementing
Executive Order 13771 (82 FR 9339, February 3, 2017), regarding what
constitutes a regulation issued ``with respect to a national security
function of the United States,'' and it is, therefore, exempt from the
requirements of E.O. 13771.
    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 OMB Control Number. This rule contains the following collections
of information subject to the requirements of the PRA. These
collections have been approved by OMB under control numbers 0694-0088
(Simplified Network Application Processing System) and 0694-0096 (Five
Year Records Retention Period). The approved information collection
under OMB control number 0694-0088 includes license applications, among
other things, and carries a burden estimate of 29.6 minutes per manual
or electronic submission for a total burden estimate of 31,833 hours.
The approved information collection under OMB control number 0694-0096
includes recordkeeping requirements and carries a burden estimate of
less than 1 minute per response for a total burden estimate of 248
hours.
    This rule contains minor clarifications to the EAR for certain
vaccines controlled by ECCN 1C991.a for anti-terrorism (AT) reasons.
Specifically, BIS expects the burden hours associated with these
collections will decrease by 5 hours and 6 minutes (i.e., 10
applications x 30.6 minutes per response) for a total estimated
decrease in cost of $153 (i.e., 5 hours and 6 minutes x $30 per hour).
The $30 per hour cost estimate for OMB control numbers 0694-0088 and
0694-0096 is consistent with the salary data for export compliance
specialists currently available through glassdoor.com (glassdoor.com
estimates that an export compliance specialist makes $55,280 annually,
which computes to roughly $26.58 per hour). Consequently, the burden
hours associated with exports of the items affected by this rule will
remain within the range of the existing

estimates currently associated with OMB control numbers 0694-0088 and
0694-0096.
    Written comments and recommendations for the information
collections referenced above should be sent within 30 days of the
publication of this final rule to: www.reginfo.gov/public/do/PRAMain.
Find these particular information collections by selecting ``Currently
under 30-day Review--Open for Public Comments'' or by using the search
function.
    3. This rule does not contain policies with Federalism implications
as that term is defined in Executive Order 13132.
    4. Pursuant to section 1762 of the Export Control Reform Act of
2018 (50 U.S.C. Sec. 4821), this action is exempt from the
Administrative Procedure Act (APA) (5 U.S.C. 553) requirements for
notice of proposed rulemaking, opportunity for public participation and
delay in effective date.
    Because a notice of proposed rulemaking and an opportunity for
public comment are not required to be given for this rule by the APA or
any other law, the analytical requirements of the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.) are not applicable. Accordingly,
no regulatory flexibility analysis is required, and none has been
prepared.

List of Subjects

15 CFR Part 742

    Exports, Terrorism.

15 CFR Part 774

    Exports, Reporting and recordkeeping requirements.

    For the reasons stated in the preamble, parts 742 and 774 of the
Export Administration Regulations (15 CFR parts 730-774) are amended as
follows:

PART 742--CONTROL POLICY--CCL BASED CONTROLS

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

    Authority: 50 U.S.C. 4801-4852; 50 U.S.C. 4601 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, 68 FR 26459, 3 CFR, 2004
Comp., p. 320; Notice of November 12, 2019, 84 FR 61817 (November
13, 2019).

0
2. In Sec.  742.2, paragraph (a)(3) is revised to read as follows:

Sec.  742.2   Proliferation of chemical and biological weapons.

    (a) * * *
    (3) If CB Column 3 of the Country Chart (Supplement No. 1 to part
738 of the EAR) is indicated in the appropriate ECCN, a license is
required to Country Group D:3 (see Supplement No. 1 to part 740 of the
EAR) for medical products identified in ECCN 1C991.c.
* * * * *

PART 774--THE COMMERCE CONTROL LIST

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

    Authority: 50 U.S.C. 4801-4852; 50 U.S.C. 4601 et seq.; 50
U.S.C. 1701 et seq.; 10 U.S.C. 8720; 10 U.S.C. 8730(e); 22 U.S.C.
287c, 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 15
U.S.C. 1824; 50 U.S.C. 4305; 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.

0
4. In Supplement No. 1 to part 774, Category 1, ECCN 1C351 is revised
to read as follows:

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

* * * * *
1C351 Human and animal pathogens and ``toxins,'' as follows (see
List of Items Controlled).

License Requirements

Reason for Control: CB, CW, AT

                                              Country chart  (see supp.
                Control(s)                       No. 1 to part 738)

CB applies to entire entry................  CB Column 1.

    CW applies to 1C351.d.11 and d.12 and a license is required for
CW reasons for all destinations, including Canada, as follows: CW
applies to 1C351.d.11 for ricin in the form of (1) Ricinus communis
AgglutininII (RCAII), also known as ricin D or Ricinus Communis
LectinIII (RCLIII) and (2) Ricinus communis LectinIV (RCLIV), also
known as ricin E. CW applies to 1C351.d.12 for saxitoxin identified
by C.A.S. #35523-89-8. See Sec.  742.18 of the EAR for licensing
information pertaining to chemicals subject to restriction pursuant
to the Chemical Weapons Convention (CWC). The Commerce Country Chart
is not designed to determine licensing requirements for items
controlled for CW reasons.

                                              Country chart  (see supp.
                Control(s)                       No. 1 to part 738)

AT applies to entire entry................  AT Column 1.

    License Requirement Notes: 1. All vaccines and `immunotoxins'
are excluded from the scope of this entry. Certain medical products
and diagnostic and food testing kits that contain biological toxins
controlled under paragraph (d) of this entry, with the exception of
toxins controlled for CW reasons under d.11 and d.12, are excluded
from the scope of this entry. Vaccines, `immunotoxins,' certain
medical products, and diagnostic and food testing kits excluded from
the scope of this entry are controlled under ECCN 1C991.
    2. For the purposes of this entry, only saxitoxin is controlled
under paragraph d.12; other members of the paralytic shellfish
poison family (e.g., neosaxitoxin) are designated EAR99.
    3. Clostridium perfringens strains, other than the epsilon
toxin-producing strains of Clostridium perfringens described in
c.12, are excluded from the scope of this entry, since they may be
used as positive control cultures for food testing and quality
control.
    4. Unless specified elsewhere in this ECCN 1C351 (e.g., in
License Requirement Notes 1-3), this ECCN controls all biological
agents and ``toxins,'' regardless of quantity or attenuation, that
are identified in the List of Items Controlled for this ECCN,
including small quantities or attenuated strains of select
biological agents or ``toxins'' that are excluded from the lists of
select biological agents or ``toxins'' by the Animal and Plant
Health Inspection Service (APHIS), U.S. Department of Agriculture
(USDA), or the Centers for Disease Control and Prevention (CDC),
U.S. Department of Health and Human Services (HHS), in accordance
with their regulations in 9 CFR part 121 and 42 CFR part 73,
respectively.
    5. Biological agents and pathogens are controlled under this
ECCN 1C351 when they are an isolated live culture of a pathogen
agent, or a preparation of a toxin agent that has been isolated or
extracted from any source or material, including living material
that has been deliberately inoculated or contaminated with the
agent. Isolated live cultures of a pathogen agent include live
cultures in dormant form or in dried preparations, whether the agent
is natural, enhanced or modified.

List Based License Exceptions (See Part 740 for a Description of All
License Exceptions)

LVS: N/A
GBS: N/A

Special Conditions for STA

STA: (1) Paragraph (c)(1) of License Exception STA (Sec.
740.20(c)(1)) may be used for items in 1C351.d.1 through 1C351.d.10
and 1C351.d.13 through 1C351.d.18. See Sec.  740.20(b)(2)(vi) for
restrictions on the quantity of any one toxin that may be exported
in a single shipment and the number of shipments that may be made to
any one end user in a single calendar year. Also see the Automated
Export System (AES) requirements in Sec.  758.1(b)(4) of the EAR.
(2) Paragraph (c)(2) of License Exception STA (Sec.  740.20(c)(2) of
the EAR) may not be used for any items in 1C351.

List of Items Controlled

Related Controls: (1) Certain forms of ricin and saxitoxin in
1C351.d.11. and d.12 are CWC Schedule 1 chemicals (see Sec.  742.18
of the EAR). The U.S. Government must provide advance notification
and annual reports to the OPCW of all exports of Schedule 1
chemicals. See Sec.  745.1 of the EAR for notification procedures.
See 22 CFR part 121, Category XIV and Sec.  121.7 for CWC Schedule 1
chemicals that are ``subject to the ITAR.'' (2) The Animal and Plant
Health Inspection Service (APHIS), U.S. Department of Agriculture,
and the Centers for Disease Control and Prevention (CDC), U.S.
Department of Health and Human Services, maintain controls on the
possession, use, and transfer within the United States of certain
items controlled by this ECCN (for APHIS, see 7 CFR 331.3(b), 9 CFR
121.3(b), and 9 CFR 121.4(b); for CDC, see 42 CFR 73.3(b) and 42 CFR
73.4(b)). (3) See 22 CFR part 121, Category XIV(b), for modified
biological agents and biologically derived substances that are
``subject to the ITAR.''
Related Definitions: For the purposes of this entry, `immunotoxins'
are monoclonal antibodies linked to a toxin with the intention of
destroying a specific target cell while leaving adjacent cells
intact.
Items:
    a. Viruses identified on the Australia Group (AG) ``List of
Human and Animal Pathogens and Toxins for Export Control,'' as
follows:
    a.1. African horse sickness virus;
    a.2. African swine fever virus;
    a.3. Andes virus;
    a.4. Avian influenza (AI) viruses identified as having high
pathogenicity (HP), as follows:
    a.4.a. AI viruses that have an intravenous pathogenicity index
(IVPI) in 6-week-old chickens greater than 1.2; or
    a.4.b. AI viruses that cause at least 75% mortality in 4- to 8-
week-old chickens infected intravenously.

    Note: Avian influenza (AI) viruses of the H5 or H7 subtype that
do not have either of the characteristics described in 1C351.a.4
(specifically, 1C351.a.4.a or a.4.b) should be sequenced to
determine whether multiple basic amino acids are present at the
cleavage site of the haemagglutinin molecule (HA0). If the amino
acid motif is similar to that observed for other HPAI isolates, then
the isolate being tested should be considered as HPAI and the virus
is controlled under 1C351.a.4.

    a.5. Bluetongue virus;
    a.6. Chapare virus;
    a.7. Chikungunya virus;
    a.8. Choclo virus;
    a.9. Classical swine fever virus (Hog cholera virus);
    a.10. Crimean-Congo hemorrhagic fever virus;
    a.11. Dobrava-Belgrade virus;
    a.12. Eastern equine encephalitis virus;
    a.13. Ebolavirus (includes all members of the Ebolavirus genus);
    a.14. Foot-and-mouth disease virus;
    a.15. Goatpox virus;
    a.16. Guanarito virus;
    a.17. Hantaan virus;
    a.18. Hendra virus (Equine morbillivirus);
    a.19. Japanese encephalitis virus;
    a.20. Junin virus;
    a.21. Kyasanur Forest disease virus;
    a.22. Laguna Negra virus;
    a.23. Lassa virus;
    a.24. Louping ill virus;
    a.25. Lujo virus;
    a.26. Lumpy skin disease virus;
    a.27. Lymphocytic choriomeningitis virus;
    a.28. Machupo virus;
    a.29. Marburgvirus (includes all members of the Marburgvirus
genus);
    a.30. Middle East respiratory syndrome-related coronavirus
(MERS-related coronavirus);
    a.31. Monkeypox virus;
    a.32. Murray Valley encephalitis virus;
    a.33. Newcastle disease virus;
    a.34. Nipah virus;
    a.35. Omsk hemorrhagic fever virus;
    a.36. Oropouche virus;
    a.37. Peste-des-petits ruminants virus;
    a.38. Porcine Teschovirus;
    a.39. Powassan virus;
    a.40. Rabies virus and all other members of the Lyssavirus
genus;
    a.41. Reconstructed 1918 influenza virus;

    Technical Note: 1C351.a.41 includes reconstructed replication
competent forms of the 1918 pandemic influenza virus containing any
portion of the coding regions of all eight gene segments.

    a.42. Rift Valley fever virus;
    a.43. Rinderpest virus;
    a.44. Rocio virus;
    a.45. Sabia virus;
    a.46. Seoul virus;
    a.47. Severe acute respiratory syndrome-related coronavirus
(SARS-related coronavirus);
    a.48. Sheeppox virus;
    a.49. Sin Nombre virus;
    a.50. St. Louis encephalitis virus;
    a.51. Suid herpesvirus 1 (Pseudorabies virus; Aujeszky's
disease);
    a.52. Swine vesicular disease virus;
    a.53. Tick-borne encephalitis virus (Far Eastern subtype,
formerly known as Russian Spring-Summer encephalitis virus--see
1C351.b.3 for Siberian subtype);
    a.54. Variola virus;
    a.55. Venezuelan equine encephalitis virus;
    a.56. Vesicular stomatitis virus;
    a.57. Western equine encephalitis virus; or
    a.58. Yellow fever virus.
    b. Viruses identified on the APHIS/CDC ``select agents'' lists
(see Related Controls paragraph #2 for this ECCN), but not
identified on the Australia Group (AG) ``List of Human and Animal
Pathogens and Toxins for Export Control,'' as follows:
    b.1. [Reserved];
    b.2. [Reserved]; or
    b.3. Tick-borne encephalitis virus (Siberian subtype, formerly
West Siberian virus--see 1C351.a.53 for Far Eastern subtype).
    c. Bacteria identified on the Australia Group (AG) ``List of
Human and Animal Pathogens and Toxins for Export Control,'' as
follows:
    c.1. Bacillus anthracis;
    c.2. Brucella abortus;
    c.3. Brucella melitensis;
    c.4. Brucella suis;
    c.5. Burkholderia mallei (Pseudomonas mallei);
    c.6. Burkholderia pseudomallei (Pseudomonas pseudomallei);
    c.7. Chlamydia psittaci (Chlamydophila psittaci);
    c.8. Clostriduim argentinense (formerly known as Clostridium
botulinum Type G), botulinum neurotoxin producing strains;
    c.9. Clostridium baratii, botulinum neurotoxin producing
strains;
    c.10. Clostridium botulinum;
    c.11. Clostridium butyricum, botulinum neurotoxin producing
strains;
    c.12. Clostridium perfringens, epsilon toxin producing types;
    c.13. Coxiella burnetii;
    c.14. Francisella tularensis;
    c.15. Mycoplasma capricolum subspecies capripneumoniae (``strain
F38'');
    c.16. Mycoplasma mycoides subspecies mycoides SC (small colony)
(a.k.a. contagious bovine pleuropneumonia);
    c.17. Rickettsia prowazekii;
    c.18. Salmonella enterica subspecies enterica serovar Typhi
(Salmonella typhi);
    c.19. Shiga toxin producing Escherichia coli (STEC) of
serogroups O26, O45, O103, O104, O111, O121, O145, O157, and other
shiga toxin producing serogroups;

    Note: Shiga toxin producing Escherichia coli (STEC) includes,
inter alia, enterohaemorrhagic E. coli (EHEC), verotoxin producing
E. coli (VTEC) or verocytotoxin producing E. coli (VTEC).

    c.20. Shigella dysenteriae;
    c.21. Vibrio cholerae; or
    c.22. Yersinia pestis.
    d. ``Toxins'' identified on the Australia Group (AG) ``List of
Human and Animal Pathogens and Toxins for Export Control,'' as
follows, or their subunits:
    d.1. Abrin;
    d.2. Aflatoxins;
    d.3. Botulinum toxins;
    d.4. Cholera toxin;
    d.5. Clostridium perfringens alpha, beta 1, beta 2, epsilon and
iota toxins;
    d.6. Conotoxins;
    d.7. Diacetoxyscirpenol;
    d.8. HT-2 toxin;
    d.9. Microcystins (Cyanginosins);
    d.10. Modeccin;
    d.11. Ricin;
    d.12. Saxitoxin;
    d.13. Shiga toxins (shiga-like toxins, verotoxins, and
verocytotoxins);
    d.14. Staphylococcus aureus enterotoxins, hemolysin alpha toxin,
and toxic shock syndrome toxin (formerly known as Staphylococcus
enterotoxin F);
    d.15. T-2 toxin;
    d.16. Tetrodotoxin;
    d.17. Viscumin (Viscum album lectin 1); or
    d.18. Volkensin.
    e. ``Fungi'', as follows:
    e.1. Coccidioides immitis; or
    e.2. Coccidioides posadasii.

0
5. In Supplement No. 1 to part 774, Category 1, ECCN 1C991 is revised
to read as follows:
1C991 Vaccines, immunotoxins, medical products, diagnostic and food
testing kits, as follows (see List of Items Controlled).

License Requirements

Reason for Control: CB, AT

                                            Country chart (see supp. No.
                Control(s)                         1 to part 738)

CB applies to 1C991.c.....................  CB Column 3.
AT applies to entire entry................  AT Column 1.

List Based License Exceptions (See Part 740 for a Description of All
License Exceptions)

LVS: N/A
GBS: N/A

List of Items Controlled

Related Controls: (1) Medical products containing ricin or
saxitoxin, as follows, are controlled for CW reasons under ECCN
1C351:

    (a) Ricinus communis AgglutininII (RCAII), also known as ricin
D, or Ricinus Communis LectinIII (RCLIII);
    (b) Ricinus communis LectinIV (RCLIV), also known as ricin E; or
    (c) Saxitoxin identified by C.A.S. #35523-89-8.
    (2) The export of a ``medical product'' that is an
``Investigational New Drug'' (IND), as defined in 21 CFR 312.3, is
subject to certain U.S. Food and Drug Administration (FDA)
requirements that are independent of the export requirements
specified in this ECCN or elsewhere in the EAR. These FDA
requirements are described in 21 CFR 312.110 and must be satisfied
in addition to any requirements specified in the EAR.
    (3) Also see 21 CFR 314.410 for FDA requirements concerning
exports of new drugs and new drug substances.

Related Definitions: For the purpose of this entry, `immunotoxins'
are monoclonal antibodies linked to a toxin with the intention of
destroying a specific target cell while leaving adjacent cells
intact. For the purpose of this entry, `medical products' are: (1)
Pharmaceutical formulations designed for testing and human (or
veterinary) administration in the treatment of medical conditions,
(2) prepackaged for distribution as clinical or medical products,
and (3) approved by the U.S. Food and Drug Administration either to
be marketed as clinical or medical products or for use as an
``Investigational New Drug'' (IND) (see 21 CFR part 312). For the
purpose of this entry, `diagnostic and food testing kits' are
specifically developed, packaged and marketed for diagnostic or
public health purposes. Biological toxins in any other
configuration, including bulk shipments, or for any other end-uses
are controlled by ECCN 1C351. For the purpose of this entry,
`vaccine' is defined as a medicinal (or veterinary) product in a
pharmaceutical formulation, approved by the U.S. Food and Drug
Administration or the U.S. Department of Agriculture to be marketed
as a medical (or veterinary) product or for use in clinical trials,
that is intended to stimulate a protective immunological response in
humans or animals in order to prevent disease in those to whom or to
which it is administered.
Items:

    Technical Note: For purposes of the controls described in this
ECCN, `toxins' refers to those toxins, or their subunits, controlled
under ECCN 1C351.d.

    a. Vaccines containing, or designed for use against, items
controlled by ECCN 1C351, 1C353 or 1C354.
    b. Immunotoxins containing toxins controlled by 1C351.d;
    c. Medical products that contain any of the following:
    c.1. Toxins controlled by ECCN 1C351.d (except for botulinum
toxins controlled by ECCN 1C351.d.3, conotoxins controlled by ECCN
1C351.d.6, or items controlled for CW reasons under ECCN 1C351.d.11
or .d.12); or
    c.2. Genetically modified organisms or genetic elements
controlled by ECCN 1C353.a.3 (except for those that contain, or code
for, botulinum toxins controlled by ECCN 1C351.d.3 or conotoxins
controlled by ECCN 1C351.d.6);
    d. Medical products not controlled by 1C991.c that contain any
of the following:
    d.1. Botulinum toxins controlled by ECCN 1C351.d.3;
    d.2. Conotoxins controlled by ECCN 1C351.d.6; or
    d.3. Genetically modified organisms or genetic elements
controlled by ECCN 1C353.a.3 that contain, or code for, botulinum
toxins controlled by ECCN 1C351.d.3 or conotoxins controlled by ECCN
1C351.d.6;
    e. Diagnostic and food testing kits containing toxins controlled
by ECCN 1C351.d (except for items controlled for CW reasons under
ECCN 1C351.d.11 or .d.12).

Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 2020-27754 Filed 1-6-21; 8:45 am]
BILLING CODE 3510-33-P


Morgan D.  NTP Toxicity Study Report on the atmospheric characterization, particle size, chemical composition...  Toxic Rep Ser 2006 Aug;(74):1-62, A1-C2
Copyrighted Submission

Available in the Technical Data Center


Kathy Kaufman/RTP/USEPA/US

04/25/2008 11:25 AM

To

"King, Heidi R."<EMAIL_ADDRESS> cc

"Lee, Amanda I."<EMAIL_ADDRESS>Charlotte Bertrand/DC/USEPA/US@EPA, Lydia Wegman/RTP/USEPA/US@EPA, "Schwab, Margo" <EMAIL_ADDRESS>"Beck, Nancy"<EMAIL_ADDRESS>Nathalie Simon/DC/USEPA/US@EPA, Neal Fann/RTP/USEPA/US@EPA, Ron Evans/RTP/USEPA/US@EPA, Tricia Crabtree/RTP/USEPA/US@EPA, Marion Hoyer/AA/USEPA/US@EPA, Tom Pace/RTP/USEPA/US@EPA, Kevin Cavender/RTP/USEPA/US@EPA, Chuck French/RTP/USEPA/US@EPA, Joe Touma/RTP/USEPA/US@EPA, Charles Fulcher/RTP/USEPA/US@EPA, Tom Walton/RTP/USEPA/US@EPA, Darryl Weatherhead/RTP/USEPA/US@EPA, Larry Wallace/RTP/USEPA/US@EPA

Subject

Re: Kathy - Items we'd like to cover at 11:30

Heidi -- here's the roadside dust presentation, just so you all can put it under your pillow over the weekend.  :-)

Kathy Kaufman

EPA/OAQPS Mail Code C539-03

Research Triangle Park, NC 27711

Phone<PHONE_NUMBER>

Fax<PHONE_NUMBER>

"King, Heidi R."<EMAIL_ADDRESS> 04/25/2008 09:56 AM

To

Kathy Kaufman/RTP/USEPA/US@EPA, "Lee, Amanda I." <EMAIL_ADDRESS>"Beck, Nancy"<EMAIL_ADDRESS>"Schwab, Margo"<EMAIL_ADDRESS> cc

Charlotte Bertrand/DC/USEPA/US@EPA, Lydia Wegman/RTP/USEPA/US@EPA, Nathalie Simon/DC/USEPA/US@EPA, Neal Fann/RTP/USEPA/US@EPA, Ron Evans/RTP/USEPA/US@EPA, Tricia Crabtree/RTP/USEPA/US@EPA

Subject

Kathy - Items we'd like to cover at 11:30

Hello again Kathy,

I'm still reading, but here are some topics we could address in our

meeting this morning at 11:30 :

- Unidentified Controls / Extrap Costs  (This is probably the highest

priority)

- Benefits baseline

- Follow up on Amanda's question about rules assumed in the baseline

- Scenario selection - OMB recommends that .5 mg/m3 should also be

analyzed

- Briefly: Could we walk through again how we moved from 189 monitors to

36 (regrets to be asking for a repeat on this subject)

- Air Qual Assessment Tool:  Re-entrained dust component, plan to

change/update for final rule RIA

Next steps, including:

- Setting aside time to walk through a few line-by-line comments and/or

questions

- Outline what changes are likely to be feasible and high priority

before signature of this proposal

- Begin to identify changes for draft final rule RIA

I hope this is helpful!  Regrets for the short notice;

heidi

-----Original Message-----

From: King, Heidi R.

Sent: Friday, April 25, 2008 7:40 AM

To<EMAIL_ADDRESS> Cc<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> Subject: RE: Responses to interagency questions on the Pb RIA

I'm sure there will be plenty of other items to discuss, I did not

organize in interagency group but rather am assembling comments -- I'm

working on assembling comments now and hopefully will have something to

you in advance of the mtg

At the very least I'll be somewhat organized.

Thanks again, Kathy --

heidi

-----Original Message-----

From<EMAIL_ADDRESS> <EMAIL_ADDRESS> Sent: Friday, April 25, 2008 12:07 AM

To: King, Heidi R.

Cc<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> Subject: RE: Responses to interagency questions on the Pb RIA

Heidi -- should be coming in the a.m.  Am awaiting an o.k. from one key

office.

Tom Pace, who put together the information, is not available for our

meeting tomorrow, though.  He's out tomorrow.  I'm assuming there will

be plenty else to discuss?

Thanks.

- Kathy

Kathy Kaufman

EPA/OAQPS Mail Code C539-03

Research Triangle Park, NC 27711

Phone<PHONE_NUMBER>

Fax<PHONE_NUMBER>

To      Kathy Kaufman/RTP/USEPA/US@EPA

      cc      Charlotte Bertrand/DC/USEPA/US@EPA, Lydia

Wegman/RTP/USEPA/US@EPA, Nathalie Simon/DC/USEPA/US@EPA, Neal

Fann/RTP/USEPA/US@EPA, Ron Evans/RTP/USEPA/US@EPA, Tricia

Crabtree/RTP/USEPA/US@EPA

      bcc

      Subject       RE: Responses to interagency questions on

the Pb RIA

"King, Heidi R."<EMAIL_ADDRESS> 04/24/2008 04:27 PM AST

Hi Kathy,

Any word on the additional materials re: dust?

Commenters asking --

heidi

-----Original Message-----

From<EMAIL_ADDRESS> <EMAIL_ADDRESS> Sent: Wednesday, April 23, 2008 10:46 AM

To: King, Heidi R.

Cc<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> Subject: Re: Responses to interagency questions on the Pb RIA

Heidi, quick typo correction in the file I sent yesterday (see attached

email):

In the answer to the first question, "from leaded avgas" was left out of

the following sentence.  It should read:

"In addition, we do not have cost estimates regarding the control of

lead emissions from leaded avgasand we can't assume a priori that these

control measures would be either more, or less expensive than point

source controls."

Thanks.  Sorry about that.

-- Kathy

Kathy Kaufman

EPA/OAQPS Mail Code C539-03

Research Triangle Park, NC 27711

Phone<PHONE_NUMBER>

Fax<PHONE_NUMBER>

Kathy

Kaufman/RTP/USEP

A/US                                                    To

"King, Heidi R."

04/22/2008 03:02<EMAIL_ADDRESS> PM                                                      cc

Charlotte

Bertrand/DC/USEPA/US@EPA,

Nathalie Simon/DC/USEPA/US@EPA,

Ron Evans/RTP/USEPA/US@EPA, Lydia

Wegman/RTP/USEPA/US@EPA, Tricia

Crabtree/RTP/USEPA/US@EPA, Neal

Fann/RTP/USEPA/US@EPA

Subject

Responses to interagency

questions on the Pb RIA(Document

link: Kathy Kaufman)

Heidi -- we drafted responses to the questions you had forwarded.

Please see the attached.

Thanks.

-- Kathy

(See attached file: Interagency responses 4-22-08.doc)

Kathy Kaufman

EPA/OAQPS Mail Code C539-03

Research Triangle Park, NC 27711

Phone<PHONE_NUMBER>

Fax<PHONE_NUMBER>


[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Notices]
[Pages 40108-40109]
[FR Doc No: 2014-16237]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-E-0434]

Determination of Regulatory Review Period for Purposes of Patent
Extension; HORIZANT

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for HORIZANT and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the

submission of an application to the Director of the U.S. Patent and
Trademark Office (USPTO), Department of Commerce, for the extension of
a patent which claims that human drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product HORIZANT
(gabapentin enacarbil). HORIZANT is indicated for the treatment of
moderate to severe primary Restless Legs Syndrome in adults. Subsequent
to this approval, the USPTO received a patent term restoration
application for HORIZANT (U.S. Patent No. 6,818,787) from XenoPort,
Inc., and the USPTO requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
July 2, 2012, FDA advised the USPTO that this human drug product had
undergone a regulatory review period and that the approval of HORIZANT
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
HORIZANT is 2,277 days. Of this time, 1,459 days occurred during the
testing phase of the regulatory review period, while 818 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: January 12, 2005. FDA has verified the applicant's claim
that the date the investigational new drug application became effective
was on January 12, 2005.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: January 9,
2009. FDA has verified the applicant's claim that the new drug
application (NDA) for Horizant (NDA 22-399) was submitted on January 9,
2009.
    3. The date the application was approved: April 6, 2011. FDA has
verified the applicant's claim that NDA 22-399 was approved on April 6,
2011.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 882 days of patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by September 9, 2014. Furthermore, any interested
person may petition FDA for a determination regarding whether the
applicant for extension acted with due diligence during the regulatory
review period by January 7, 2015. To meet its burden, the petition must
contain sufficient facts to merit an FDA investigation. (See H. Rept.
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should
be in the format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-16237 Filed 7-10-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 31 (Tuesday, February 15, 2022)]
[Notices]
[Page 8631]
[FR Doc No: 2022-03196]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Docket No. FAA-2022-0201]

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Certification:
Pilots and Flight Instructors

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request Office of
Management and Budget (OMB) approval to renew an information
collection. FAA regulations prescribe certification standards for
pilots, flight instructors, and ground instructors. The information
collected is used to determine compliance with applicant eligibility.

DATES: Written comments should be submitted by April 18, 2022.

ADDRESSES: Send comments to the FAA at the following address: Dwayne C.
Morris, Federal Aviation Administration, 800 Independence Ave. SW,
Washington, DC 20591; email: [email protected].
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

FOR FURTHER INFORMATION CONTACT: Jean Hardy by email at:
[email protected]. phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0021.
    Title: Certification: Pilots and Flight Instructors.
    Form Numbers: 8710-1, 8710-13.
    Type of Review: This is a renewal of an existing information
collection.
    Background: Persons applying for an airman certificate under part
61 are mandated to report information using the Airman certificate and/
or Rating Application form and the required records, logbooks and
statements to the Federal Aviation Administration (FAA) Flight
Standards District Offices or its representatives on occasion. This
information is used to determine qualifications of the applicant for
issuance of a pilot or instructor certificate, or rating or
authorization. The FAA estimates that there are approximately 825,000
active certificated pilot airmen. This includes student, private,
commercial, airline transport pilot certificate holders, as well as
ground and flight instructors. Approximately 25% of these pilots are
providing data on an annual basis. Instructor certificates must be
renewed every 24 months to remain effective. If the information
collection were not conducted, the FAA would be unable to issue the
appropriate certificates and ratings. Persons applying for a remote
pilot certificate with a small UAS rating under part 107, are mandated
to report information using the FAA Form 8710-13, Remote Pilot
Certificate and/or Rating Application. For applicants who do not hold a
pilot certificate under part 61, the Remote Pilot Certificate and/or
Rating Application is submitted along with a documentation
demonstrating that the applicant passed an aeronautical knowledge test.
For applicants who hold a pilot certificate under part 61 and meet the
flight review requirements of Sec.  61.56, the Remote Pilot Certificate
and/or Rating Application is submitted with evidence of completion of
the training program is estimated to be approximately 25 percent of the
population of active certificated pilots and instructors. Given a
population of 825,000, the result is approximately 206,250 respondents
providing data on an annual basis. The total number of applicants for a
remote pilot certificate with a small UAS rating is estimated to be
39,229 annually.
    Frequency: As needed.
    Estimated Average Burden per Response: For the hour burdens
resulting from the application requirements of the collection of
information other than remote pilots with small UAS ratings, the FAA
estimates that forms are submitted for these certificates and ratings
at an average preparation time of 15 minutes (0.25 hrs) each. The
average time estimate of 0.25 hours assumes that many individual
applicants will submit an 8710-1 form more than once for various
reasons, and that most of the information provided on the form likely
will not have changed. For Part 107 we estimate that an average of
39,229 forms are submitted annually that require an average preparation
time of 0.25 hours to complete.
    Estimated Total Annual Burden: The total number of annual responses
for the airman certification program is estimated to be 1,171,0405. The
FAA estimates the total reporting burden hours to be 43,157 hours. The
FAA estimates the total recordkeeping burden hours to be 282,329 hours.
The FAA estimates the burden for the collection of information to be
325,486 hours annually.

    Issued in Washington, DC, on February 9, 2022.
Dwayne C. Morris,
Project Manager, Flight Standards Service.
[FR Doc. 2022-03196 Filed 2-14-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 190 (Tuesday, October 1, 2013)]
[Notices]
[Pages 60279-60280]
[FR Doc No: 2013-23784]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9901-55-OCFO]

Notice of Open Meeting of the Environmental Financial Advisory
Board (EFAB)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The United States Environmental Protection Agency's (EPA)
Environmental Financial Advisory Board (EFAB) will hold a full board
meeting on October 22-23, 2013. EFAB is an EPA advisory committee
chartered under the Federal Advisory Committee Act (FACA) to provide
advice and recommendations on environmental financing issues. EFAB
focuses its advice and recommendations on promoting sustainability by
reducing environmental costs; increasing public and private investment;
and building state, local, and tribal financial capacity.
    The purpose of the meeting is to hear from informed speakers on
environmental finance issues, review Agency challenges and priorities;
discuss progress with EFAB work projects currently underway; review and
consider requests for assistance from EPA offices as well as
suggestions from EFAB members; and, to develop EFAB's FY 2014 Strategic
Action Agenda.
    Environmental Finance topics expected to be discussed include:
Transit-Oriented Development in Sustainable Communities; Drinking Water
Pricing and Infrastructure Investment; and Green Infrastructure.
    The meeting is open to the public, however, seating is limited. All
members of the public who wish to attend the meeting must register in
advance, no later than Friday, October 11, 2013.

DATES: Full Board Meeting is scheduled for Tuesday, October 22, 2013
from 10:15 a.m. to 5:00 p.m. and Wednesday, October 23, 2013 from 8:30
a.m. to 3:00 p.m.

ADDRESSES: EPA Potomac Yards North Bldg., 2733 S. Crystal City Drive,
Room 4120, Arlington, VA 22202.

Registration and Information Contact

    To register for this meeting or get further information, please
contact Sandra Williams, U.S. EPA, at<PHONE_NUMBER> or
<EMAIL_ADDRESS>For information on access or services for
individuals with disabilities, please contact Sandra Williams. To
request accommodations of a disability, contact Sandra Williams,
preferably at least 10

days prior to the meeting, to give EPA as much time as possible to
process your request.

    Dated: September 18, 2013.
Joseph L. Dillon,
Director, Center for Environmental Finance.
[FR Doc. 2013-23784 Filed 9-30-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 156 (Wednesday, August 12, 2020)]
[Rules and Regulations]
[Pages 48645-48646]
[FR Doc No: 2020-16280]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 85, No. 156 / Wednesday, August 12, 2020 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2020-0519; Special Conditions No. 25-773-SC]

Special Conditions: Aerospace Design and Compliance, LLC,
Bombardier, Inc. Model CL-600-2B19 Airplane; Installation of a
Therapeutic Oxygen System for Medical Use

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions.

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

SUMMARY: These special conditions are issued for the Bombardier Inc.
(Bombardier) Model CL-600-2B19 airplane. This airplane, as modified by
Aerospace Design and Compliance, LLC (Aerospace Design and Compliance),
will have a novel or unusual design feature when compared to the state
of technology envisioned in the airworthiness standards for transport
category airplanes. The design feature is an installation of a
therapeutic oxygen system for medical use. The applicable airworthiness
regulations do not contain adequate or appropriate safety standards for
this design feature. These special conditions contain the additional
safety standards that the Administrator considers necessary to
establish a level of safety equivalent to that established by the
existing airworthiness standards.

DATES: Effective August 12, 2020.

FOR FURTHER INFORMATION CONTACT: Robert Hettman, Propulsion &
Mechanical Systems, AIR-672, Transport Standards Branch, Policy and
Innovation Division, Aircraft Certification Service, Federal Aviation
Administration, 2200 South 216th Street, Des Moines, Washington 98198;
telephone and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    On November 20, 2019, Aerospace Design and Compliance applied for a
supplemental type certificate for the installation of a therapeutic
oxygen system for medical use in the executive interiors of the
Bombardier Model CL-600-2B19 airplane. The Model CL-600-2B19 airplane,
which is currently approved under Type Certificate No. A21EA, is a
twin-engine transport airplane with a maximum takeoff weight of 47,450
lbs. The Model CL-600-2B19 airplane will have 55 seats approved for
taxi, takeoff, and landing.

Type Certification Basis

    Under the provisions of title 14, Code of Federal Regulations (14
CFR) 21.101, Aerospace Design and Compliance must show that the
Bombardier Model CL-600-2B19 airplane, as changed, continues to meet
the applicable provisions of the regulations listed in Type Certificate
No. A21EA, or the applicable regulations in effect on the date of
application for the change, except for earlier amendments as agreed
upon by the FAA.
    If the Administrator finds that the applicable airworthiness
regulations (e.g., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the Bombardier Model CL-600-2B19
airplane because of a novel or unusual design feature, special
conditions are prescribed under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the applicant apply for a supplemental type
certificate to modify any other model included on the same type
certificate to incorporate the same novel or unusual design feature,
these special conditions would also apply to the other model under
Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the Bombardier Model CL-600-2B19 airplane must comply with
the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and
the noise certification requirements of 14 CFR part 36.
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type
certification basis under Sec.  21.101.

Novel or Unusual Design Features

    The Bombardier Model CL-600-2B19 airplane will incorporate the
following novel or unusual design features:
    A therapeutic oxygen system for medical use.
    As a part of the executive interior installation, the gaseous
passenger-oxygen system will be outfitted with a therapeutic oxygen
system. The therapeutic oxygen system shares the same supply of oxygen
with the existing passenger oxygen system and consists of multiple
constant-flow oxygen outlets located throughout the cabin. The
flightcrew can turn the therapeutic oxygen system on and off from the
flightdeck to allow use at any point during the flight, and to preserve
a sufficient remaining oxygen reserve, in the event therapeutic oxygen
is used for medical purposes, to accommodate the passengers in the
event of an emergency oxygen situation.

Discussion

    No specific regulations address the design and installation of
required passenger oxygen systems that share a supply source with an
optional oxygen system used specifically for therapeutic applications.
Therapeutic oxygen systems have been previously certified, and were
generally considered an extension of the passenger oxygen system for
the purpose of defining the applicable regulations. As a result,
existing requirements, such as Sec. Sec.  25.1309, 25.1441(b) and (c),
25.1451, and 25.1453, in the Bombardier Model CL-600-2B19 airplanes'
certification basis applicable to this STC project, provide some design
standards appropriate for oxygen system installations. In addition,
Sec.  25.1445 includes standards for oxygen distribution systems when
oxygen is supplied to flightcrew and passengers. If a common source of
supply is used, Sec.  25.1445(a)(2) requires a means to separately
reserve the minimum supply required by the flightcrew.
    Section 25.1445 is intended to protect the flightcrew by ensuring
that an adequate supply of oxygen is available to complete a descent
and landing following a loss of cabin pressure. When the regulation was
written, the only passenger oxygen system designs were supplemental
oxygen systems intended to protect passengers from hypoxia in the event
of a decompression. Existing

passenger oxygen systems did not include design features that would
allow the flightcrew to control oxygen to passengers during flight.
There are no similar requirements in Sec.  25.1445 when oxygen is
supplied from the same source to passengers for use during a
decompression, and for discretionary or first-aid use any time during
the flight. In the design, the passenger and therapeutic oxygen systems
use the same source of oxygen. These special conditions contain
additional design requirements for the equipment involved in this dual
therapeutic oxygen plus gaseous oxygen installation.
    Furthermore, the potential hazard that can exist when the oxygen
content of an enclosed area becomes too high because of system leaks,
malfunction, or damage from external sources, make it necessary to
ensure that adequate safety standards are applied to the design and
installation of the oxygen system in Bombardier Model CL-600-2B19
airplanes. These potential hazards also necessitate development and
application of appropriate additional design and installation
standards.
    These special conditions contain the additional safety standards
that the Administrator considers necessary to establish a level of
safety equivalent to that established by the existing airworthiness
standards.

Discussion of Comments

    The FAA issued Notice of Proposed Special Conditions No. 25-20-06-
SC for the Bombardier Model CL-600-2B19 airplane, which was published
in the Federal Register on June 16, 2020 (85 FR 36351). No substantive
comments were received, and the special conditions are adopted as
proposed.

Applicability

    As discussed above, these special conditions are applicable to the
Bombardier Model CL-600-2B19 airplane. Should Aerospace Design and
Compliance apply at a later date for a supplemental type certificate to
modify any other model included on Type Certificate No. A21EA to
incorporate the same novel or unusual design feature, these special
conditions would apply to that model as well.
    Under standard practice, the effective date of final special
conditions would be 30 days after the date of publication in the
Federal Register. However, as the certification date for the Bombardier
Model CL-600-2B19 airplane is imminent, the FAA finds that good cause
exists to make these special conditions effective upon publication.

Conclusion

    This action affects only a certain novel or unusual design feature
on one model of airplane. It is not a rule of general applicability and
affects only the applicant who applied to the FAA for approval of these
features on the airplane.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

Authority Citation

    The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Bombardier Model CL-600-2B19
airplanes, as modified by Aerospace Design and Compliance, LLC.
    The distribution system for the passenger therapeutic oxygen
systems must be designed and installed to meet requirements as follows:
    1. When oxygen is supplied to passengers for both supplemental and
therapeutic purposes, the distribution system must be designed for
either--
    a. A source of supplemental oxygen for protection following a loss
of cabin pressure, and a separate source for therapeutic purposes: Or
    b. A common source of supply with means to separately reserve the
minimum supply required by the passengers for supplemental use
following a loss of cabin pressure.

    Issued in Des Moines, Washington, on July 22, 2020.
James E. Wilborn,
Acting Manager, Transport Standards Branch, Policy and Innovation
Division, Aircraft Certification Service.
[FR Doc. 2020-16280 Filed 8-11-20; 8:45 am]
BILLING CODE P


[Federal Register: August 24, 2010 (Volume 75, Number 163)]
[Notices]
[Page 52057-52058]
[DOCID:fr24au10-112]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Office of Hazardous Materials Safety; Notice of Delays in
Processing of Special Permits Applications

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of applications delayed more than 180 days.

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

SUMMARY: In accordance with the requirements of 49 U.S.C. 5117(c),
PHMSA is publishing the following list of special permit applications
that have been in process for 180 days or more. The reason(s) for delay
and the expected completion date for action on each application is
provided in association with each identified application.

FOR FURTHER INFORMATION CONTACT: Delmer F. Billings, Director, Office
of Hazardous Materials Special Permits and Approvals, Pipeline and
Hazardous Materials Safety Administration, U.S. Department of
Transportation, East Building, PHH-30, 1200 New Jersey Avenue,
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.

Key to ``Reason for Delay''

    1. Awaiting additional information from applicant.
    2. Extensive public comment under review.
    3. Application is technically complex and is of significant impact
or precedent-setting and requires extensive analysis.
    4. Staff review delayed by other priority issues or volume of
special permit applications.

Meaning of Application Number Suffixes

    N--New application.
    M--Modification request.
    PM--Party to application with modification request.

    Issued in Washington, DC, on August 18, 2010.
Donald Burger,
Chief, Special Permits and Approvals Branch.

------------------------------------------------------------------------
                                            Reason for    Estimated date
    Application No.         Applicant          delay       of completion
------------------------------------------------------------------------
                     Modification to Special Permits
------------------------------------------------------------------------
14167-M...............  Trinityrail,                   4      03-31-2011
                         Dallas, TX.
6293-M................  ATK Space                      4      03-31-2011
                         Systems, Inc.
                         (Former
                         Grantee: ATK
                         Thiokol, Inc.),
                         Corine, UT.
14741-M...............  Weatherford                    4      03-31-2011
                         International,
                         Fort Worth, TX.
8826-M................  Phoenix Air                    4      03-31-2011
                         Group, Inc.,
                         Cartersville,
                         GA.
14650-M...............  Air Transport                  4      03-31-2011
                         International,
                         L.L.C., Little
                         Rock, AR.
14926-M...............  Lynden Air                     4      11-30-2010
                         Cargo,
                         Anchorage, AK.
14808-M...............  Amtrol, Inc.,                  4      03-31-2011
                         West Warwick,
                         RI.
8826-M................  Phoenix Air                    4      03-31-2011
                         Group, Inc.,
                         Cartersville,
                         GA.
10869-M...............  Norris Cylinder                4      03-31-2011
                         Company,
                         Longview, TX.
13736-M...............  ConocoPhillips,                4      03-31-2011
                         Anchorage, AK.
------------------------------------------------------------------------
                     New Special Permit Applications
------------------------------------------------------------------------
14810-N...............  Olin                           4      03-31-2011
                         Corporation,
                         Chlor Alkai
                         Products
                         Division,
                         Cleveland, TN.
14813-N...............  Organ Recovery                 4      03-31-2011
                         Systems, Des
                         Plaines, IL.
14832-N...............  Trinity                        4      03-31-2011
                         Industries,
                         Inc., Dallas,
                         TX.
14835-N...............  The Reusable                   4      03-31-2011
                         Industrial
                         Packaging
                         Assoc.,
                         Washington, DC.
14839-N...............  Matheson Tri-                  3      11-30-2010
                         Gas, Inc.,
                         Basking Ridge,
                         NJ.
14851-N...............  Alaska Air                     4      03-31-2011
                         Group, Inc.,
                         Seattle, WA.
14868-N...............  Wal-Mart Stores,               4      03-31-2011
                         Inc.,
                         Bentonville, AR.
14878-N...............  Humboldt County                4      03-31-2011
                         Waste
                         Management
                         Authority,
                         Eureka, CA.
14872-N...............  Arkema, Inc.,                  4      03-31-2011
                         Philadelphia,
                         PA.
14921-N...............  ERA Helicopters                4      11-30-2010
                         LLE, Lake
                         Charles, LA.
14899-N...............  MGH Management                 4      03-31-2011
                         Group, LLC.
14929-N...............  Alaska Island                  4      11-30-2010
                         Air, Inc.,
                         Togiak, AK.
14933-N...............  Tobin                          4      03-31-2011
                         Scientific, a
                         division of
                         Tobin & Sons
                         Moving and
                         Storage, Inc.,
                         Peabody, MA.
14940-N...............  Crown Aerosol                  4      11-30-2010
                         Packaging,
                         Philadelphia,
                         PA.
14945-N...............  Vulcan                         4      03-31-2011
                         Construction
                         Materials LP
                         SE, db/a Vulcan
                         Materials
                         Company,
                         Atlanta, GA.
14951-N...............  Lincoln                        1      11-30-2010
                         Composites,
                         Lincoln, NE.
14952-N...............  Mebrom NV,                     1      11-30-2010
                         Ertvelde-Rieme.
14960-N...............  Cheltec, Inc.,                 4      03-31-2011
                         Sarasota, FL.
14965-N...............  JiangXi Oxygen                 4      11-30-2010
                         Plant Co.,
                         Ltd., Jiangxi
                         Province.
14972-N...............  Air Products and               4      11-30-2010
                         Chemicals,
                         Allentown, PA.
14977-N...............  Air Products and               4      03-31-2011
                         Chemicals,
                         Inc.,
                         Allentown, PA.
14980-N...............  Boehlke Bottled                4      03-31-2011
                         Gas Corp.,
                         Cedarburg, WI.
------------------------------------------------------------------------

[FR Doc. 2010-20911 Filed 8-23-10; 8:45 am]
BILLING CODE 4910-60-M