[Federal Register Volume 75, Number 220 (Tuesday, November 16, 2010)]
[Notices]
[Pages 70060-70061]
[FR Doc No: 2010-28746]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63278; File No. SR-OCC-2010-05]

 Self-Regulatory Organizations; The Options Clearing Corporation;
Order Granting Approval of a Proposed Rule Change Relating to Cash-
Settled Foreign Currency Options With One-Cent Exercise Prices

November 8, 2010.

I. Introduction

    On March 16, 2010, The Options Clearing Corporation (``OCC'') filed
with the Securities and Exchange Commission (``Commission'') a proposed
rule change pursuant to Section 19(b)(1) of the Securities Exchange Act
of 1934 (``Act'') \1\ and Rule 19b-4 thereunder \2\ to clarify that
cash-settled foreign currency options traded on national securities
exchanges will be treated and cleared as securities options
notwithstanding that they may have a nominal exercise price such as one
cent. The proposed rule change was published for comment in the Federal
Register on April 7, 2010.\3\ No comment letters were received on the
proposal. This order approves the proposal.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 61820 (Apr. 1, 2010), 75
FR 17805.
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II. Description of the Proposal

    OCC will add a sentence to the Introduction to Article XXII of its
By-Laws to make clear that cash-settled foreign currency options traded
on national securities exchanges will be treated and cleared as
securities options notwithstanding that they may have a nominal
exercise price such as one cent.\4\
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    \4\ The exact language of the proposal can be seen at http://www.theocc.com/component/docs/legal/rules_and_bylaws/sr_OCC_10_05.pdf.

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    In its capacity as a ``derivatives clearing organization''
registered as such with the Commodities Futures Trading Commission, OCC
also filed this proposed rule change with the CFTC for prior approval
pursuant to provisions of the Commodity Exchange Act (``CEA'') in order
to foreclose any potential argument that the clearing by OCC of such
options as securities options constitutes a violation of the CEA. The
products involved here are essentially the same as cash-settled foreign
currency options that OCC currently clears except for the low strike
price.

III. Discussion

    Section 17A(b)(3)(F) of the Act \5\ requires, among other things,
that the rules of a clearing agency be designed to promote the prompt
and accurate clearance and settlement of securities transactions and
derivative transactions. OCC's clarification of its By-Laws with
respect to cash-settled foreign currency options with nominal exercise
prices should help reduce the likelihood of confusion as to OCC's
treatment of such products, and accordingly should help to promote the
prompt and accurate clearance and settlement of securities
transactions.
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    \5\ 15 U.S.C. 78q-1(b)(3)(F).
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IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposed rule change is consistent with the requirements of the Act and
in particular Section 17A of the Act \6\ and the rules and regulations
thereunder.
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    \6\ 15 U.S.C. 78q-1.
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    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\7\ that the proposed rule change (File No. SR-OCC-2010-05) be and
hereby is approved.\8\
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    \7\ 15 U.S.C. 78s(b)(2).
    \8\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition and
capital formation. 15 U.S.C. 78c(f).

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\9\
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    \9\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-28746 Filed 11-15-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: December 21, 2005 (Volume 70, Number 244)]
[Notices]
[Page 75813-75817]
[DOCID:fr21de05-52]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2005-0462; FRL-7754-3]

Certain New Chemicals; Receipt and Status Information

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Section 5 of the Toxic Substances Control Act (TSCA) requires
any person who intends to manufacture (defined by statute to include
import) a new chemical (i.e., a chemical not on the TSCA Inventory) to
notify EPA and comply with the statutory provisions pertaining to the
manufacture of new chemicals. Under sections 5(d)(2) and 5(d)(3) of
TSCA, EPA is required to publish a notice of receipt of a
premanufacture notice (PMN) or an application for a test marketing
exemption (TME), and to publish periodic status reports on the
chemicals under review and the receipt of notices of commencement to
manufacture those chemicals. This status report, which covers the
period from November 8, 2005 to November 16, 2005, consists of the PMNs
and TMEs, both pending or expired, and the notices of commencement to
manufacture a new chemical that the Agency has received under TSCA
section 5 during this time period.

DATES: Comments identified by the docket ID number EPA-HQ-OPPT-2005-
0462 and the specific PMN number or TME number, must be received on or
before January 20, 2006.

ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Colby Lintner, Regulatory Coordinator,
Environmental Assistance Division, Office of Pollution Prevention and
Toxics (7408M), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>;
e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. As such, the
Agency has not attempted to describe the specific entities that this
action may apply to. Although others may be affected, this action
applies directly to the submitter of the premanufacture notices
addressed in the action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number EPA-HQ-OPPT-2005-0462.
The official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the EPA Docket Center, Rm.
B102-Reading Room, EPA West, 1301 Constitution Ave., NW., Washington,
DC. The EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The EPA Docket Center Reading
Room telephone number is<PHONE_NUMBER>, and the telephone number for
the OPPT Docket, which is located in the EPA Docket Center, is (202)
566-0280.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.

    EDOCKET, EPA's electronic public docket and comment system was
replaced on November 25, 2005 by an

enhanced federal-wide electronic docket management and comment system
located at http://www.regulations.gov/. Follow the on-line

instructions.
    An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public

comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B.1. EPA intends to work
towards providing electronic access to all of the publicly available
docket materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.

C. How and To Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number and specific PMN number or TME number in
the subject line on the first page of your comment. Please ensure that
your comments are submitted within the specified comment period.
Comments received after the close of the comment period will be marked
``late.'' EPA is not required to consider these late comments. If you
wish to submit CBI or information that is otherwise protected by
statute, please follow the instructions in Unit I.D. Do not use EPA
Dockets or e-mail to submit CBI or information protected by statute.
    1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/
, and follow the online instructions for submitting comments.

Once in the system, select ``search,'' and then key in docket ID number
EPA-HQ-OPPT-2005-0462. The system is an ``anonymous access'' system,
which means EPA will not know your identity, e-mail address, or other
contact information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to<EMAIL_ADDRESS>
Attention: Docket ID Number EPA-HQ-OPPT-2005-0462 and PMN Number or TME
Number. In contrast to EPA's electronic public docket, EPA's e-mail
system is not an ``anonymous access'' system. If you send an e-mail
comment directly to the docket without going through EPA's electronic
public docket, EPA's e-mail system automatically captures your e-mail
address. E-mail addresses that are automatically captured by EPA's e-
mail system are included as part of the comment that is placed in the
official public docket, and made available in EPA's electronic public
docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Document Control Office (7407M),
Office of Pollution Prevention and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    3. By hand delivery or courier. Deliver your comments to: OPPT
Document Control Office (DCO) in EPA East Bldg., Rm. 6428, 1201
Constitution Ave., NW., Washington, DC. Attention: Docket ID Number
EPA-HQ-OPPT-2005-0462 and PMN Number or TME Number. The DCO is open
from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
The telephone number for the DCO is<PHONE_NUMBER>.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.

    In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the technical person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the notice or collection
activity.
    7. Make sure to submit your comments by the deadline in this
document.
    8. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action and the specific PMN number you are
commenting on in the subject line on the first page of your response.
You may also provide the name, date, and Federal Register citation.

II. Why is EPA Taking this Action?

    Section 5 of TSCA requires any person who intends to manufacture
(defined by statute to include import) a new chemical (i.e., a chemical
not on the TSCA Inventory to notify EPA and comply with the statutory
provisions pertaining to the manufacture of new chemicals. Under
sections 5(d)(2) and 5(d)(3) of TSCA, EPA is required to publish a
notice of receipt of a PMN or an application for a TME and to publish
periodic status reports on the chemicals under review and the receipt
of notices of commencement to manufacture those chemicals. This status
report, which covers the period from November 8, 2005 to November 16,
2005, consists of the PMNs and TMEs, both pending or expired, and the
notices of commencement to manufacture a new chemical that the Agency
has received under TSCA section 5 during this time period.

III. Receipt and Status Report for PMNs and TMEs

    This status report identifies the PMNs and TMEs, both pending or
expired, and the notices of commencement to manufacture a new chemical
that the Agency has received under TSCA section 5 during this time
period. If you are interested in information that is not included in
the following tables, you may contact EPA as described in Unit II. to
access additional non-CBI information that may be available.
    In Table I of this unit, EPA provides the following information (to
the extent that such information is not claimed as CBI) on the PMNs
received by EPA during this period: the EPA case number assigned to the
PMN; the date the PMN was received by EPA; the projected end date for
EPA's review of the PMN; the submitting manufacturer; the potential
uses identified by the manufacturer in the PMN; and the chemical
identity.

                                            I. 15 Premanufacture Notices Received From: 11/08/05 to 11/16/05
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Projected Notice End
              Case No.                    Received Date               Date           Manufacturer/Importer           Use                  Chemical
--------------------------------------------------------------------------------------------------------------------------------------------------------
P-06-0121                            11/08/05                02/06/06                Zeon Chemicals L.P.    (S) automotive timing  (G) modified
                                                                                belts; oilfield        acrylonitrile
                                                                                wellhead seals, blow   butadiene polymer
                                                                                out preventers
P-06-0122                            11/08/05                02/05/06                CBI                    (G) Destructive use    (G) Base oil
P-06-0123                            11/08/05                02/05/06                CBI                    (G) Open, non-         (G)
                                                                                dispersive use         Cuprate[[[[[[(substi
                                                                                tuted)
                                                                                sulfonaphtalenyl]-
                                                                                azo]-
                                                                                substitutedphenyl]-
                                                                                sulfonyl] -ethyl]-
                                                                                glycinato], sodium
                                                                                salts
P-06-0124                            11/08/05                02/05/06                Cytec Industries Inc.  (G) Sulfide mineral    (G) Modified
                                                                                processing reagent     thionocarbamate
P-06-0125                            11/08/05                02/05/06                CBI                    (G) Surfactant         (G) Benzoic acid
                                                                                (substituted)-, akyl
                                                                                vegetable oil
                                                                                derivatives
P-06-0127                            11/14/05                02/11/06                Esprix Technologies    (G) Polymer reactant   (G) Modified butyl
                                                                                acrylate
P-06-0128                            11/15/05                02/12/06                CBI                    (G) Fuel additive      (G) Iron-based
                                                                                organic complex
P-06-0129                            11/15/05                02/12/06                CBI                    (G) Open-non-          (G) Alkylpolysulfide
                                                                                dispersive use
P-06-0130                            11/15/05                02/04/06                CBI                    (G) Open-non-          (G) Alkylpolysulfide
                                                                                dispersive use
P-06-0131                            11/15/05                02/12/06                Shin-Etsu Silicones    (S) Additive of        (S) Siloxanes and
                                                                                of America Inc.        adhesives for          silicones, hydroxy
                                                                                building materials     me, 3-hydroxypropyl
                                                                                me, me (1-
                                                                                oxooctyl)oxy, esters
                                                                                with C12	20 fatty
                                                                                acids, ethers with
                                                                                polyethylene-
                                                                                polypropylene glycol
                                                                                mono-bu ether
P-06-0132                            11/15/05                02/12/06                CBI                    (G) Polymer for        (G) 2-propenoic acid,
                                                                                waterborne paints      aklyl-, polymer with
                                                                                ethenylbenzene,
                                                                                alkyl propenoates, 2-
                                                                                hydroxyalkyl
                                                                                propenoate,
                                                                                alkylperoxoate-
                                                                                initiated, compounds
                                                                                with aminoalkanol

P-06-0133                            11/15/05                02/12/06                CBI                    (G) Polymer for        (G) 2-propenoic acid,
                                                                                waterborne paints      alkyl-, alkyl ester,
                                                                                polymer with alkyl
                                                                                propenoate and
                                                                                oxiranylalkyl
                                                                                propenoate
P-06-0134                            11/15/05                02/12/06                Degussa Corporation    (S) Hotmelts for the   (G) Polyester of
                                                                                automotive industry;   aliphatic/aromatic
                                                                                hotmelts for the       dicarboxylic acid,
                                                                                woodworking industry   alkane diol and
                                                                                ester diol
P-06-0135                            11/14/05                02/11/06                Eliokem, Inc.          (G) Resin for imaging  (S) Tert-
                                                                                application            dodecanethiol,
                                                                                telomer with 2-
                                                                                propenoic acid, 2-
                                                                                ethylhexyl ester and
                                                                                ethenylbenzene
P-06-0136                            11/16/05                02/13/06                PPG Industries, Inc.   (G) Component of an    (G) Cycloaliphatic
                                                                                industrial coating     acid, alkyl
                                                                                substituted-, mixed
                                                                                esters with
                                                                                cycloaliphatic acid
                                                                                and 2-alkane
                                                                                substituted
                                                                                bis(alkanediol)
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In Table II of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the TMEs
received:

                                        II. 1 Test Marketing Exemption Notice Received From: 11/08/05 to 11/16/05
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Projected Notice End
              Case No.                    Received Date               Date           Manufacturer/Importer           Use                  Chemical
--------------------------------------------------------------------------------------------------------------------------------------------------------
T-06-0002                            11/16/05                12/30/05                PPG Industries, Inc.   (G) Component of an    (G) Cycloaliphatic
                                                                                industrial coating     acid, alkyl
                                                                                substituted-, mixed
                                                                                esters with
                                                                                cycloaliphatic acid
                                                                                and 2-alkane
                                                                                substituted
                                                                                bis(alkanediol)
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In Table III of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the
Notices of Commencement to manufacture received:

                           III. 16 Notices of Commencement From: 11/08/05 to 11/16/05
----------------------------------------------------------------------------------------------------------------
                                                                Commencement Notice
              Case No.                     Received Date             End Date                  Chemical
----------------------------------------------------------------------------------------------------------------
P-04-0650                             11/09/05                11/04/05                (S) Reaction catalyzed:
                                                                                Aryl dialkyl phosphate +
                                                                                H2O odialkyl phosphate +
                                                                                an aryl acohol acts on
                                                                                organophosphorus
                                                                                compounds (such as
                                                                                paraoxon) including
                                                                                esters of phosphonic and
                                                                                phosphinic acid
P-04-0781                             11/08/05                10/31/05                (G) Acrylic polymer
P-05-0348                             11/08/05                10/19/05                (G) Dialkyldiallylsodium
                                                                                halide with unsaturated
                                                                                phosphonic acid,
                                                                                acrylamido alkyl propane
                                                                                sulfonic acid sodium
                                                                                salt, and two substituted
                                                                                monomers.
P-05-0349                             11/08/05                10/19/05                (G) Dialkyldiallylsodium
                                                                                halide with unsaturated
                                                                                phosphonic acid,
                                                                                acrylamido alkyl propane
                                                                                sulfonic acid sodium
                                                                                salt, and two substituted
                                                                                monomers.
P-05-0527                             11/08/05                10/10/05                (G) Polymer of
                                                                                formaldehyde and
                                                                                substituted phenols
P-05-0578                             11/10/05                10/15/05                (G) Isocyanate functional
                                                                                poly carbomoyl
                                                                                (polyalkylene oxide)
P-05-0600                             11/09/05                10/24/05                (G) Sulfato cycohexene
                                                                                aliphatic sulfo
                                                                                substituted imidazole
                                                                                napthyl salt
P-05-0614                             11/15/05                10/11/05                (S) 1-octanethiol,
                                                                                manufacturer of, distn.
                                                                                residues, high-boiling
                                                                                fraction.
P-05-0615                             11/15/05                10/11/05                (S) 1-octanethiol,
                                                                                manufacturer of, distn.
                                                                                residues, low-boiling
                                                                                fraction.
P-05-0626                             11/15/05                10/11/05                (S) Thiols, C11	13-
                                                                                tertiary, C12-rich,
                                                                                manufacturer of, C12-rich
                                                                                C11	13 alkene-based,
                                                                                distn. residues, high-
                                                                                boiling fraction.
P-05-0627                             11/15/05                10/11/05                (S)Thiols, C11	13-
                                                                                tertiary, C12-rich,
                                                                                manufacturer of,
                                                                                propylene tetramer-based,
                                                                                distn. residues, high-
                                                                                boiling fraction
P-05-0628                             11/15/05                10/11/05                (S) Thiols, C11	13-
                                                                                tertiary, C12-rich,
                                                                                manufacturer of, C12	13
                                                                                alkenes-based, distn.
                                                                                residues, middle-boiling
                                                                                fraction.
P-05-0629                             11/15/05                10/11/05                (S)Definition: Thiols,
                                                                                C11	13-tertiary, C12-
                                                                                rich, manufacture of,
                                                                                propylene tertramer-
                                                                                based, distn, residues,
                                                                                middle-boiling fraction.
P-05-0630                             11/15/05                10/11/05                (S)Thiols, C11	13-
                                                                                tertiary, C12-rich,
                                                                                manfacturer of, C12-rich
                                                                                C11	13 alkenes-based,
                                                                                distn. residues, low
                                                                                boiling fraction.
P-05-0631                             11/15/05                10/11/05                (S) Thiols, C11	13-
                                                                                tertiary, C12-rich,
                                                                                manufacturer of,
                                                                                propylene tetramer-based,
                                                                                distn. residues, low
                                                                                boiling fraction.
P-05-0649                             11/09/05                10/12/05                (G) Benzene,1,1'-
                                                                                methylenebis[isocyanato-,
                                                                                polymer with 2-propenoic
                                                                                acid, 2-hydroxyethyl
                                                                                ester and lexorez 1180-35
                                                                                and lexorez 1640-35
----------------------------------------------------------------------------------------------------------------

List of Subjects

    Environmental protection, Chemicals, Premanufacturer notices.

    Dated: December 13, 2005
Carolyn Thorton,
Acting Director, Information Management Division, Office of Pollution
Prevention and Toxics.

[FR Doc. 05-24197 Filed 12-20-05; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: May 18, 2010 (Volume 75, Number 95)]
[Notices]
[Page 27776]
[DOCID:fr18my10-59]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2144-038; Project No. 2225-013]

City of Seattle, Public Utility District No. 1 of Pend Orielle
County; Notice of Technical Conference and Site Visit for the Boundary
Hydroelectric Project and Sullivan Creek Hydroelectric Project
Settlement Agreement and Soliciting Scoping Comments on the Proposed
Sullivan Creek Hydroelectric Project Surrender

May 11, 2010.
    On March 29, 2010, the City of Seattle (City) and the Public
Utility District No. 1 of Pend Oreille, County, Washington (District)
filed a joint comprehensive settlement agreement (Settlement),
explanatory statement and a request to consolidate the processing of
the City's relicensing of the Boundary Hydroelectric Project No. 2144-
038, and the District's surrender of its license for the Sullivan Creek
Hydroelectric Project No. 2225-013. On April 2, 2010, the District
filed an application to surrender the Sullivan Creek Project. Parts of
both projects occupy lands within the Colville National Forest.

Technical Conference

    Commission staff will hold a technical conference to discuss the
proposed license articles for a new license for the Boundary Project
and the proposed Sullivan Creek license surrender conditions submitted
as part of the joint Settlement.
    The technical conference will be held on Thursday, June 10, 2010,
beginning at 9 a.m. (PST) at Quality Inn Oakwood, 7919 North Division,
Spokane, WA. Participation at the technical conference will be limited
to Commission staff and the Settlement Parties. However, the public is
free to attend and provide comments on the scope of issues that should
be addressed in the Commission's environmental assessment. The
technical conference will be recorded by a court reporter, and all
statements (verbal and written) will become part of the Commission's
public record for the project. The conference and site visit described
below are posted on the Commission's calendar located at http://
www.ferc.gov/EventCalendar/EventsList.aspx along with other related
information.

Site Visit

    On Wednesday, June 9, 2010, Commission staff, along with
representatives of the City and the District, will conduct a site visit
of the Boundary and Sullivan Creek Projects. All interested
individuals, organizations, and agencies are invited to attend. All
participants should meet at the Boundary powerhouse gate at 10:15 a.m.
(PST). For those persons only interested in the Sullivan Creek
surrender, we will be at the Sullivan Lake Dam at 12:15 p.m. In
addition, all participants are responsible for their own transportation
to the site and throughout the day. Anyone planning to attend the site
visit must notify Mary Pat Dileva at<EMAIL_ADDRESS>by
Wednesday, June 2, 2010. RSVPs are required for security and planning
purposes.

Scoping for the Surrender of the District's Sullivan Creek Project

    Commission staff intends to prepare an environmental assessment
(EA) covering both the relicensing of the Boundary Project and the
surrender of the Sullivan Creek Project, pursuant to the National
Environmental Policy Act of 1969, as amended. Scoping of the
relicensing of the Boundary Project was completed in 2006. To support
and assist our environmental review, we are conducting paper scoping of
the Sullivan Creek surrender to ensure that all pertinent issues are
identified and analyzed, and the EA is thorough. This notice solicits
written comments from Federal, State, and local resource agencies,
Indian tribes, and other interested persons through the scoping
process.
    All scoping comments should be submitted in writing to the
Commission no later than June 25, 2010. All correspondence must clearly
show at the top of the page: ``Sullivan Creek Hydroelectric Project,
FERC No. 2225-013.'' Send your comments about the project to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426. Scoping comments may be filed
electronically via the Internet in lieu of paper. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
at http://www.ferc.gov under the ``e-Filing'' link. The Commission
strongly encourages electronic filings.
    For further information, contact David Turner at<PHONE_NUMBER>, or
by e-mail at<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. 2010-11791 Filed 5-17-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 27 (Tuesday, February 10, 2015)]
[Notices]
[Pages 7459-7460]
[FR Doc No: 2015-02696]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2004-0016; FRL-9922-76-OAR]

Proposed Information Collection Request; Comment Request; Federal
Operating Permit Program; Renewal

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``Part 71 Federal
Operating Permit Program (Renewal)'' (EPA ICR No. 1713.10, OMB Control
No. 2060.0336) to the Office of Management and Budget (OMB) for review
and approval in accordance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.). Before doing so, the EPA is soliciting public
comments on specific aspects of the proposed information collection as
described below. This is a proposed extension of the ICR, which is
currently approved through June 30, 2015. An agency may not conduct or
sponsor and a person is not required to respond to a collection of
information unless it displays a currently valid OMB control number.

DATES: Comments must be submitted on or before April 13, 2015.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2004-0016, online using www.regulations.gov (our preferred method), by
email to<EMAIL_ADDRESS>or by mail to: EPA Docket Center,
Environmental Protection Agency, WJC West, Room 3334, 1301 Constitution
Ave. NW., Washington, DC 20460.
    The EPA's policy is that all comments received will be included in
the public docket including any personal information provided, unless
the comment includes profanity, threats, information claimed to be
Confidential Business Information or other information whose disclosure
is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Joanna W. Gmyr, Air Quality Policy
Division, Office of Air Quality Planning and Standards, C504-05, U.S.
Environmental Protection Agency, Research Triangle Park, NC; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, William
Jefferson Clinton West Building, Room 3334, 1301 Constitution Avenue
NW, Washington, DC The telephone number for the Docket Center is (202)
566-1744. For additional information about the EPA's public docket,
visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, the EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., allowing electronic submission of responses. The EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, the EPA will issue another Federal Register
notice to announce the submission of the ICR to OMB and the opportunity
to submit additional comments to OMB.
    Abstract: Title V of the Clean Air Act (Act) requires the EPA to
operate a federal operating permits program in areas not subject to an
approved state program. The EPA regulations setting forth the
requirements for the federal (EPA) operating permit program are at 40
CFR part 71. The part 71 program is designed to be implemented
primarily by the EPA in all areas where state and local agencies do not
have jurisdiction, such as Indian country and offshore, beyond states'
seaward boundaries. The EPA may also delegate authority to implement
the part 71 program on its behalf to a state, local or tribal agency,
if the agency requests delegation and makes certain showings regarding
its authority and ability to implement the program. One such delegate
agency for the part 71 program exists at present.
    In order to receive an operating permit for a major or other source
subject to the permitting program, the applicant must conduct the
necessary research, perform the appropriate analyses, and prepare the
permit application with documentation to demonstrate that its facility
meets all applicable statutory and regulatory requirements. Specific
activities and requirements are listed and described in the Supporting
Statement for the part 71 ICR.
    Under part 71, the permitting authority (the EPA or a delegate
agency)

reviews permit applications, provides for public review of proposed
permits, issues permits based on consideration of all technical factors
and public input, and reviews information submittals required of
sources during the term of the permit. Under part 71, the EPA reviews
certain actions and performs oversight of any delegate agency,
consistent with the terms of a delegation agreement. Consequently,
information prepared and submitted by sources is essential for sources
to receive permits, and for federal and tribal permitting agencies to
adequately review the permit applications and issue the permits,
oversee implementation of the permits, and properly administer and
manage the program. The proposed ICR is needed to authorize the
preparation and submittal of this information.
    Information that is collected is handled according to EPA's
policies set forth in title 40, chapter 1, part 2, subpart B--
Confidentiality of Business Information (see 40 CFR part 2). See also
section 114(c) of the Act.
    Form Numbers: The forms are 5900-01, 5900-02, 5900-03, 5900-04,
5900-05, 5900-06, 5900-79, 5900-80, 5900-81, 5900-82, 5900-83, 5900-84,
5900-85 and 5900-86.
    Respondents/affected entities: Industrial plants (sources) and
tribal permitting authorities.
    Respondent's obligation to respond: mandatory (see 40 CFR part 71).
    Estimated number of respondents: 99 (total); 98 industry sources
and 1 tribal delegate permitting authority (the EPA serves as a
permitting authority but is not a respondent).
    Frequency of response: On occasion.
    Total estimated burden: 26,132 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $1,702,183 (per year). There are no
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is a decrease of 11,497 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This decrease is due to updated estimates of the
number of sources and permits subject to the part 71 program, rather
than any new federal mandates. The changes in estimates are due to
shrinkage from the transfer of 36 permits from the part 71 to the part
70 program and due to a previous overestimate of the number of sources
that would get permits by the end of the previous ICR (which is the
start of the current ICR).

    Dated: January 29, 2015.
Stephen D. Page,
Director, Office of Air Quality Planning and Standards.
[FR Doc. 2015-02696 Filed 2-9-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Rules and Regulations]
[Pages 37500-37502]
[FR Doc No: 2016-13798]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2015-D-3539]

Interim Policy on Compounding Using Bulk Drug Substances Under
Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a guidance for industry entitled
``Interim Policy on Compounding Using Bulk Drug Substances Under
Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The
guidance describes FDA's interim regulatory policy regarding
outsourcing facilities that compound human drug products using bulk
drug substances while FDA develops the list of bulk drug substances
that can be used in compounding under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act).

DATES: Submit electronic or written comments on Agency guidances at any
time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the

manner detailed (see ``Written/Paper Submissions'' and
``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-D-3539 for ``Interim Policy on Compounding Using Bulk Drug
Substances Under Section 503B of the Federal Food, Drug, and Cosmetic
Act''. Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993-0002, 301-
796-3110.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Interim Policy on Compounding Using Bulk Drug Substances
Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' A new
section 503B (21 U.S.C. 353b), added to the FD&C Act by the Drug
Quality and Security Act in 2013, describes the conditions that must be
satisfied for human drug products compounded by an outsourcing facility
to be exempt from the following three sections of the FD&C Act: Section
505 (21 U.S.C. 355) (concerning the approval of drugs under new drug
applications or abbreviated new drug applications); section 502(f)(1)
(21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate
directions for use); and section 582 (21 U.S.C. 360eee-1) (concerning
drug supply chain security requirements). One of the conditions that
must be met for a drug product compounded by an outsourcing facility to
qualify for these exemptions is that the outsourcing facility does not
compound drug products using a bulk drug substance unless: It appears
on a list established by the Secretary identifying bulk drug substances
for which there is a clinical need (see section 503B(a)(2)(A)(i) of the
FD&C Act); or the drug compounded from such bulk drug substances
appears on the drug shortage list in effect under section 506E of the
FD&C Act (21 U.S.C. 356e) at the time of compounding, distribution, and
dispensing (see section 503B(a)(2)(A)(ii) of the FD&C Act).
    This guidance describes the conditions under which FDA does not
intend to take action against an outsourcing facility for compounding a
drug product from a bulk drug substance that does not appear on a list
of bulk drug substances that can be used in compounding and is not used
to compound a drug product that appears on the FDA drug shortage list
at the time of compounding, distribution, and dispensing, while FDA
develops the list of bulk drug substances that can be used in
compounding pursuant to section 503B(a)(2)(A)(i) of the FD&C Act (503B
bulks list).\1\
---------------------------------------------------------------------------

    \1\ Elsewhere in this issue of the Federal Register, the Agency
is making available a guidance entitled ``Interim Policy on
Compounding Using Bulk Drug Substances Under Section 503A of the
Federal Food, Drug, and Cosmetic Act,'' which describes the
conditions under which FDA does not intend to take action against a
licensed pharmacist in a State-licensed pharmacy or Federal
facility, or a licensed physician, for compounding a drug product
from a bulk drug substance that cannot otherwise be used in
compounding under section 503A of the FD&C Act while FDA develops
the list of bulk drug substances that can be used in compounding
under section 503A(b)(1)(A)(i)(III).
---------------------------------------------------------------------------

    The guidance also describes FDA's process to establish the 503B
bulks list, and it describes categories of substances that were
nominated for inclusion on the 503B bulks list. These categories
include:
     503B Category 1--Bulk Drug Substances Under Evaluation:
These bulk drug substances may be eligible for inclusion on the 503B
bulks list, were nominated with sufficient supporting information for
FDA to evaluate them, and do not appear on any other list.
     503B Category 2--Bulk Drug Substances That Raise
Significant Safety Risks: These bulk drug substances were nominated
with sufficient supporting information to permit FDA to evaluate them
and they may be eligible for inclusion on the 503B bulks list. However,
FDA has identified significant safety risks relating to the use of
these bulk substances in compounding, and therefore does not intend to
adopt the policy described for the bulk substances in Category 1.
     503B Category 3--Bulk Drug Substances Nominated Without
Adequate Support: These bulk drug substances may be eligible for
inclusion on the 503B bulks list but were nominated with insufficient
supporting information for FDA to evaluate them. These substances can
be re-nominated with sufficient supporting information

through a docket that FDA has established.
    In the Federal Register of October 27, 2015 (80 FR 65768), FDA
issued a notice announcing the availability of the draft version of
this guidance. The comment period on the draft guidance ended on
December 28, 2015. FDA received 11 comments on the draft guidance. In
response to received comments or on its own initiative, FDA made
several changes to the guidance to clarify particular points. In
addition, FDA has made the following updates to the lists on its Web
site of bulk drug substances that were nominated for inclusion on the
503A bulks list: \2\
---------------------------------------------------------------------------

    \2\ In the future, if FDA makes changes to the categories of
bulk drug substances on its Web site, we intend to follow the
procedure identified in the guidance.
---------------------------------------------------------------------------

     503B Category 2: FDA has added one bulk drug substances to
Category 2, germanium sesquioxide, because FDA identified significant
safety risks relating to the use of this bulk drug substance in
compounding.
     503B Category 4: The draft interim guidance included a
fourth category of bulk drug substances that would have identified
substances that FDA evaluated for inclusion on the 503B bulks list but,
after obtaining and considering public comments, decided not to place
on the 503B bulks list. In the final interim guidance, FDA removed this
fourth category because the Agency intends to identify the bulk drug
substances that will not be placed on the 503B bulks list in the
Federal Register notice that establishes the 503B bulks list.
Therefore, we do not believe it is necessary to also include them in
the categories identified in this guidance.

II. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: June 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13798 Filed 6-9-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: March 12, 2008 (Volume 73, Number 49)]
[Rules and Regulations]
[Page 13117-13120]
[DOCID:fr12mr08-19]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0263; Directorate Identifier 2008-NM-044-AD;
Amendment 39-15423; AD 2008-06-11]
RIN 2120-AA64

Airworthiness Directives; Saab Model SAAB SF340A and SAAB 340B
(Including Variant 340B (WT)) Series Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    Subsequent to an incident on January 2, 2006, when a Saab 340B
airplane encountered icing conditions during en route climb and
departed controlled flight, the NTSB (National Transportation Safety
Board) has issued a number of safety recommendations.
* * * * *
The unsafe condition is possible stalling while operating in icing
conditions, which could result in loss of control of the airplane. This
AD requires actions that are intended to address the unsafe condition
described in the MCAI.

DATES: This AD becomes effective March 27, 2008.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of March 27,
2008.
    We must receive comments on this AD by April 11, 2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, International Branch, ANM-116, Transport Airplane
Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057-3356;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued
Airworthiness Directive 2008-0022, dated January 29, 2008 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    Subsequent to an incident on January 2, 2006, when a Saab 340B
airplane encountered icing conditions during en route climb and
departed controlled flight, the NTSB (National Transportation Safety
Board) has issued a number of safety recommendations.
    Different safety actions have been discussed and agreed upon
[among] Saab, FAA and EASA (European Aviation Safety Agency) since
then to meet the NTSB safety recommendations.
    For the reasons described above, this Airworthiness Directive
(AD) requires the amendment of the applicable Saab SF340A or 340B
Airplane Flight Manual (AFM) to incorporate the changes to the
Limitations section and the Performance section as specified in the
AFM revisions listed in the * * * AD.

The unsafe condition is possible stalling while operating in icing
conditions, which could result in loss of control of the airplane. You
may obtain further information by examining the MCAI in the AD docket.
    On April 19, 1996, we issued AD 96-01-04 R1, amendment 39-9582 (61
FR 18242, April 25, 1996). That AD is applicable to certain Saab Model
SAAB SF340A and SAAB 340B series airplanes. Paragraph (a)(3) of AD 96-
01-04 R1 requires revising the Limitations Section of the airplane
flight manual (AFM) by inserting certain icing procedures into that
section. Accomplishing the actions required by this new AD terminates
the actions required by paragraph (a)(3) of AD 96-01-04 R1.
    On November 10, 1999, we issued AD 99-19-14, amendment 39-11303 (64
FR 63622, November 22, 1999). That AD is applicable to certain Saab
Model SAAB SF340A, SAAB 340B, and SAAB 2000 series airplanes. Paragraph
(a) of AD 99-19-14 requires revising the Limitations Section of the AFM
to include certain requirements for activation of the icing protection
systems. Accomplishing the actions required by this new AD terminates
the actions required by paragraph (a) of AD 99-19-14 for Model SAAB
SF340A and SAAB 340B series airplanes.

Relevant Service Information

    SAAB has issued the following revisions to the SAAB SF340A and 340B
AFMs:

----------------------------------------------------------------------------------------------------------------
                 AFM                        Document No.       Revision level                 Date
----------------------------------------------------------------------------------------------------------------
SAAB SF340A.........................  AFM 340 A 001..........              51  November 30, 2007.
SAAB 340B...........................  72LKS5968..............              21  November 30, 2007.
SAAB 340B...........................  AFM 340 B 001..........              29  November 30, 2007.
----------------------------------------------------------------------------------------------------------------

    The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are issuing this AD because we
evaluated all pertinent information and determined the unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between the AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the AD.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule to prevent
possible stalling while operating in icing conditions, which could
result in loss of control of the airplane. Therefore, we determined
that notice and opportunity for public comment before issuing this AD
are impracticable and that good cause exists for making this amendment
effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2008-0263; Directorate
Identifier 2008-NM-044-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2008-06-11 Saab AB, Saab Aerosystems (Formerly Saab Aircraft AB):
Amendment 39-15423. Docket No. FAA-2008-0263; Directorate Identifier
2008-NM-044-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective March
27, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all Saab Model SAAB SF340A and SAAB 340B
(including Variant 340B (WT)) series airplanes, certificated in any
category.

Subject

    (d) Air Transport Association (ATA) of America Code 30: Ice and
rain protection.

Reason

    (e) The mandatory continued airworthiness information (MCAI)
states:

    Subsequent to an incident on January 2, 2006, when a Saab 340B
airplane encountered icing conditions during en route climb and
departed controlled flight, the NTSB (National Transportation Safety
Board) has issued a number of safety recommendations.
    Different safety actions have been discussed and agreed upon
[among] Saab, FAA and EASA (European Aviation Safety Agency) since
then to meet the NTSB safety recommendations.
    For the reasons described above, this Airworthiness Directive
(AD) requires the amendment of the applicable Saab SF340A or 340B
Airplane Flight Manual (AFM) to incorporate the changes to the
Limitations section and the Performance section as specified in the
AFM revisions listed in the * * * AD.

The unsafe condition is possible stalling while operating in icing
conditions, which could result in loss of control of the airplane.

Actions and Compliance

    (f) Within 30 days after the effective date of this AD, unless
already done, revise the Limitations and Performance sections in the
applicable AFM specified in Table 1 of this AD by incorporating the
information in the applicable revision specified in Table 1.

                                            Table 1.--Applicable AFMs
----------------------------------------------------------------------------------------------------------------
                 AFM                        Document No.       Revision level                 Date
----------------------------------------------------------------------------------------------------------------
SAAB SF340A.........................  AFM 340 A 001..........              51  November 30, 2007.
SAAB 340B...........................  72LKS5968..............              21  November 30, 2007.
SAAB 340B...........................  AFM 340 B 001..........              29  November 30, 2007.
----------------------------------------------------------------------------------------------------------------

    Note 1: The action required by paragraph (f) of this AD may be
done by inserting into the appropriate AFM sections a copy of the
applicable revision listed in Table 1 of this AD. When this revision
has been included in the general revisions of the AFM, the general
revisions may be inserted into the AFM, provided the relevant
information in the general revision is identical to that in the
revision listed in Table 1 of this AD.

    Note 2: The AFM areas affected by this AD are:
    (1) Definition of icing conditions;
    (2) Operation in icing conditions;
    (3) Minimum airspeeds in icing conditions;
    (4) Auto pilot mode in icing conditions; and
    (5) Landing field length charts, including effect of
VREF speed increment.

Terminating Actions

    (g) For Model SAAB SF340A and SAAB 340B airplanes: Accomplishing
the actions required by paragraph (f) of this AD terminates the
actions required by paragraph (a)(3) of AD 96-01-04 R1 and paragraph
(a) of AD 99-19-14.

FAA AD Differences

    Note 3: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (h) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. Send information to Attn: Shahram Daneshmandi, Aerospace
Engineer, International Branch, ANM-116, Transport Airplane
Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before using any
approved AMOC on any airplane to which the AMOC applies, notify your
appropriate principal inspector (PI) in the FAA Flight Standards
District Office (FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (i) Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2008-0022, dated January 29, 2008, and the applicable AFM
revision specified in Table 1 of this AD, for related information.

Material Incorporated by Reference

    (j) You must use the service information specified in Table 2 of
this AD to do the actions required by this AD, unless the AD
specifies otherwise.

                                  Table 2.--Material Incorporated by Reference
----------------------------------------------------------------------------------------------------------------
                                                                    Revision
               Document                         Page Nos.            level                   Date
----------------------------------------------------------------------------------------------------------------
SAAB SF340A Airplane Flight Manual,     List of Effective Pages:          51  November 30, 2007.
 AFM 340 A 001.                          Pages 1-4 through 1-6.
SAAB 340B Airplane Flight Manual,       List of Effective Pages:          21  November 30, 2007.
 72LKS5968.                              Pages 1-4 through 1-7.
SAAB 340B Airplane Flight Manual, AFM   List of Effective Pages:          29  November 30, 2007.
 340 B 001.                              Pages 1-4 through 1-6.
----------------------------------------------------------------------------------------------------------------

    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact Saab
Aircraft AB, SAAB Aircraft Product Support, S-581.88,
Link[ouml]ping, Sweden.
    (3) You may review copies at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>,
or go to: http://www.archives.gov/federal-register/cfr/ibr-
locations.html.

    Issued in Renton, Washington, on March 3, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E8-4660 Filed 3-11-08; 8:45 am]

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