[Federal Register: December 15, 2006 (Volume 71, Number 241)]
[Notices]
[Page 75546-75551]
[DOCID:fr15de06-76]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2006-0967; FRL-8106-7]

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 October 16, 2006 to November 12, 2006, 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 specific PMN number or TME number,
must be received on or before January 16, 2007.

ADDRESSES:  Submit your comments, identified by docket identification
(ID) no. EPA-HQ-OPPT-2006-0967, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO, EPA East
Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID

number EPA-HQ-OPPT-2006-0967. 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>. Such deliveries are only accepted during
the Docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2006-0967. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
 http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' systems,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov your
e-mail address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD ROM you submit. 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. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the
regulations.gov index. Although listed in the index, some information
is not publicly available, e.g., CBI or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available electronically at
http://www.regulations.gov, or, if only available in hard copy, at the

OPPT Docket, EPA Docket Center (EPA/DC). The EPA/DC suffered structural
damage due to flooding in June 2006. Although the EPA/DC is continuing
operations, there will be temporary changes to the EPA/DC during the
clean-up. The EPA/DC Public Reading Room, which was temporarily closed
due to flooding, has been relocated in the EPA Headquarters Library,
Infoterra Room (Room Number 3334) in the EPA West Building, located at
1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number of the EPA/DC Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPPT
Docket is<PHONE_NUMBER>. EPA visitors are required to show
photographic identification and sign the EPA visitor log. Visitors to
the EPA/DC Public Reading Room will be provided with an EPA/DC badge
that must be visible at all times while in the EPA Building and
returned to the guard upon departure. In addition, security personnel
will escort visitors to and from the new EPA/DC Public Reading Room
location. Up-to-date information about the EPA/DC is on the EPA web
site at http://www.epa.gov/epahome/dockets.htm.

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:
(202) 554-1404; 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. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, 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 claimed CBI). In addition to one complete
version of the comment that includes 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. Information so
marked will not be disclosed except in accordance with procedures set
forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions - The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at the estimate.
    vi. Provide specific examples to illustrate your concerns, and
suggested alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

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 October 16, 2006 to November 12,
2006, 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

    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. 46 Premanufacture Notices Received From: 10/02/06 to 11/12/06
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Projected Notice End
              Case No.                    Received Date               Date           Manufacturer/Importer           Use                  Chemical
--------------------------------------------------------------------------------------------------------------------------------------------------------
P-07-0041                            10/17/06                01/14/07                Piedmont Chemical      (S) Binder resin for   (S) 1,3-
                                                                                Industries I, LLC      polyester fabric       benzenedicarboxylic
                                                                                knit and nonwoven;     acid, polymer with
                                                                                binder resin for       1,4-
                                                                                mattress ticking       benzenedicarboxylic
                                                                                polyester/             acid, 1,3-dihydro-
                                                                                polypropylene knit;    1,3-dioxo-5-
                                                                                binder resin for       isobenzofurancarboxy
                                                                                nylon strapping        lic acid, 2,2'-
                                                                                oxybis[ethanol] and
                                                                                1,3-propanediol
P-07-0042                            10/17/06                01/14/07                Piedmont Chemical      (S) Binder resin for   (S) 1,3-
                                                                                Industries I, LLC      polyester fabric       benzenedicarboxylic
                                                                                knit and nonwoven;     acid, polymer with
                                                                                binder resin for       1,4-
                                                                                mattress ticking       benzenedicarboxylic
                                                                                polyester/             acid, 1,3-dihydro-
                                                                                polypropylene knit;    1,3-dioxo-5-
                                                                                binder resin for       isobenzofurancarboxy
                                                                                nylon strapping        lic acid, dimethyl
                                                                                1,4-
                                                                                benzenedicarboxylate
                                                                                , 1,2-ethanediol and
                                                                                2,2'-oxybis
                                                                                [ethanol]
P-07-0043                            10/17/06                01/14/07                Piedmont Chemical      (S) Binder resin for   (S) 1,3-
                                                                                Industries I, LLC      polyester fabric       benzenedicarboxylic
                                                                                knit and nonwoven;     acid, polymer with
                                                                                binder resin for       1,4-
                                                                                mattress ticking       benzenedicarboxylic
                                                                                polyester/             acid, 1,4-
                                                                                polypropylene knit;    butanediol,1,3-
                                                                                binder resin for       dihydro-1,3-dioxo-5-
                                                                                nylon strapping        isobenzofurancarboxy
                                                                                lic acid, dimethyl
                                                                                1,4-
                                                                                benzenedicarboxylate
                                                                                and 2,2'-
                                                                                oxybis[ethanol]
P-07-0044                            10/17/06                01/14/07                Piedmont chemical      (S) Binder resin for   (S) 2,6-
                                                                                industries I, LLC      polyester fabric       naphthalenedicarboxy
                                                                                knit and nonwoven;     lic acid, dimethyl
                                                                                binder resin for       ester, polymer with
                                                                                mattress ticking       1,3-
                                                                                polyester/             benzenedicarboxylic
                                                                                polypropylene knit;    acid, 1,4-
                                                                                binder resin for       benzenedicarboxylic
                                                                                nylon strapping        acid, 1,3-dihydro-
                                                                                1,3-dioxo-5-
                                                                                isobenzofurancarboxy
                                                                                lic acid, 1,2-
                                                                                ethanediol and 2,2'-
                                                                                oxybis [ethanol]
P-07-0045                            10/17/06                01/14/07                CBI                    (G) Open non           (G) Polyacrylate
                                                                                dispersive (binder     resin
                                                                                material)
P-07-0046                            10/18/06                01/15/07                International flavors  (S) Raw material for   (S) 4h-indeno[4,5-d]-
                                                                                and fragrances, Inc.   use in fragrances      1,3-dioxole,
                                                                                for soaps,             3a,5,6,7,8,8b-
                                                                                detergents, cleaners   hexahydro-
                                                                                and other household    2,2,6,6,7,8,8-
                                                                                products               heptamethyl-
P-07-0047                            10/17/06                01/14/07                CBI                    (G) Textile colorant   (G) Di-substituted
                                                                                acetanilide
P-07-0048                            10/17/06                01/14/07                Dupont Company         (G) Raw material for   (G) Salt of amine
                                                                                polymer production     with aliphatic acid
P-07-0049                            10/17/06                01/14/07                Dupont Company         (G) Extrusion          (G) Aliphatic
                                                                                compounding resin;     polyamide
                                                                                molding resin
P-07-0050                            10/17/06                01/14/07                CBI                    (G) Open non-          (G) Polyester
                                                                                dispersive             polyurethane resin
                                                                                polyurethane resin     based on 1,5-
                                                                                naphthylene
                                                                                diisocyanate
P-07-0051                            10/18/06                01/15/07                CBI                    (G) Metal working      (G) Polyethylene
                                                                                fluid                  glycol ether acid
P-07-0052                            10/18/06                01/15/07                Huntsman               (S) Exhaust            (G) Benzenesulfonic
                                                                                International, LLC     application to         acid azo
                                                                                cotton fabrics         benzenesulfonic acid
                                                                                azo substituted
                                                                                naphthalenesulfonic
                                                                                acid amino
                                                                                substituted triazine
                                                                                amino substituted
                                                                                phenyl sulfonyl
                                                                                compound
P-07-0053                            10/18/06                01/15/07                CBI                    (S) Flavor             (G) Oils, watermelon,
                                                                                ingredient;            citrullus lanatus
                                                                                fragrance
                                                                                ingredient; cosmetic
                                                                                ingredient
P-07-0054                            10/19/06                01/16/07                Henkel Corporation     (S) A component of     (S) Hexanedioic acid,
                                                                                adhesive               polymer with 1,3-
                                                                                formulations           diisocyanatomethylbe
                                                                                nzene and 3-methyl-
                                                                                1,5-pentanediol,
                                                                                propylene gylcol
                                                                                monomethacrylate-
                                                                                blocked

P-07-0055                            10/20/06                01/17/07                CBI                    (G) Additive, open,    (G) 2-
                                                                                non-dispersive use     (dimethylamino)ethyl
                                                                                methyl-2-propanoate,
                                                                                polymer with alkyl-
                                                                                substituted methyl-2-
                                                                                propanoate and aryl-
                                                                                substituted methyl-2-
                                                                                propanoate, salt
                                                                                with mono(alkyl-
                                                                                substituted
                                                                                polyalkoxyether)buta
                                                                                nedioates and alkyl-
                                                                                substituted
                                                                                polyalkoxyether
                                                                                phosphate
P-07-0056                            10/23/06                01/20/07                CIBA Specialty         (S) High molecular     (G) Modified
                                                                                Chemicals              weight pigment         polyacrylate block
                                                                                Corporation            dispersant for         polymer
                                                                                waterborne coatings
P-07-0057                            10/23/06                01/20/07                Mane, USA              (G) Perfumery          (G) Alkyl substituted
                                                                                ingredient             tetrahydro pyran
P-07-0058                            10/23/06                01/20/07                Firmenich Inc.         (S) Aroma for use in   (S) 3-hexene, 1-(2-
                                                                                fragrance mixtures,    butenyloxy)-, (3z)-
                                                                                which in turn are
                                                                                used in perfumes,
                                                                                soaps, cleansers,
                                                                                etc.
P-07-0059                            10/25/06                01/22/07                CBI                    (G) Automotive         (G) Cyclic acrylic
                                                                                coatings               polymer, peroxide
                                                                                initiated
P-07-0060                            10/27/06                01/24/07                3M                     (G) Monomer            (G) Aliphatic
                                                                                acrylate
P-07-0061                            10/27/06                01/24/07                3M                     (G) Adhesive           (G) Acrylate
                                                                                copolymer
P-07-0062                            10/27/06                01/24/07                CBI                    (G) Raw material       (G) Amine salt of
                                                                                carbomonocyclic
                                                                                acids
P-07-0063                            10/27/06                01/24/07                CBI                    (G) Coating component  (G) Polymer of
                                                                                styrene, acrylic
                                                                                acid derivatives and
                                                                                alkyl methacrylate
P-07-0064                            10/30/06                01/27/07                CBI                    (S) Resin for          (G) Modified rosin,
                                                                                printing ink           hydrocarbon resin
P-07-0065                            10/30/06                01/27/07                CBI                    (G) Moisture curing    (G) Isocyanate
                                                                                polyurethane           terminated urethane
                                                                                adhesives              polymer
P-07-0066                            10/30/06                01/27/07                PPG Industries, Inc.   (G) Component of an    (G) Trimellitic
                                                                                automotive primer      anhydride, polymer
                                                                                with alkanediol,
                                                                                dihydroxyalkane
                                                                                diglycidyl ether di-
                                                                                3,5,5-
                                                                                trimethylhexanoate
                                                                                homopolymer,
                                                                                ethoxylated
                                                                                bis(hydroxysubstitut
                                                                                ed) alkane and
                                                                                heteromonocycledione
                                                                                , compound with 2-
                                                                                (dimethylamino)
                                                                                ethanol
P-07-0067                            10/30/06                01/27/07                CBI                    (G) Sodium salt of     (G) Sodium salt of an
                                                                                acrylic copolymer      acrylic copolymer
P-07-0068                            10/30/06                01/27/07                CBI                    (G) Open non-          (G) Polyester resin
                                                                                dispersive (coatings
                                                                                application)
P-07-0069                            10/25/06                01/22/07                The Dow Chemical       (G) Binders for        (G) Mdi and polymeric
                                                                                Company                granulated rubber      mdi prepolymer
                                                                                surfacing and
                                                                                molding
P-07-0070                            10/25/06                01/22/07                The Dow Chemical       (G) Binders for        (G) Mdi and polymeric
                                                                                Company                granulated rubber      mdi prepolymer
                                                                                surfacing and
                                                                                molding
P-07-0071                            10/25/06                01/22/07                The Dow Chemical       (G) Binders for        (G) Mdi and polymeric
                                                                                Company                granulated rubber      mdi prepolymer
                                                                                surfacing and
                                                                                molding
P-07-0072                            10/30/06                01/27/07                CBI                    (S) Catalyst for       (G) Alkanoic acid
                                                                                production of foam     potassium salt
P-07-0073                            10/30/06                01/27/07                CBI                    (G) Ingredient         (G) Acrylic resin
                                                                                material in paint      solution
                                                                                formulation
P-07-0074                            11/02/06                01/30/07                CBI                    (S) Reactive diluent   (G) Alkoxylated
                                                                                in ultra violet        pentaerythritol
                                                                                formulations           acrylate
P-07-0075                            11/02/06                01/30/07                CBI                    (G) Additive for       (G) Acrylic polymer
                                                                                paper manufacturing    with vinyl compound,
                                                                                salt
P-07-0076                            11/02/06                01/30/07                CBI                    (G) Component of       (G) Benzene, 1,1'-
                                                                                manufactured           [1,2-
                                                                                consumer article-      ethanediylbis(oxy)bi
                                                                                contained use          s[polymethyl-
P-07-0077                            11/03/06                01/31/07                CBI                    (G) Raw material for   (G) Copolymer of
                                                                                food packaging         alkene-alkenyl
                                                                                container
P-07-0078                            11/03/06                01/31/07                CBI                    (G) Additive for       (G) Acrylic polymer
                                                                                paper manufacturing    salt with vinyl
                                                                                compound, salts
P-07-0079                            11/03/06                01/31/07                CBI                    (S) Light stabilizer   (G) Substituted
                                                                                for plastic articles   piperidinol,
                                                                                carbonate
P-07-0080                            11/08/06                02/05/07                Cognis Corporation     (S) Biodegradable      (S) Nonanedioic acid,
                                                                                hydraulic fluid for    bis(2-hexyldecyl)
                                                                                use in construction    ester
                                                                                equipment ie.,
                                                                                bullldozers, cranes
                                                                                etc.
P-07-0081                            11/08/06                02/05/07                Cognis Corporation     (S) Biodegradable      (S) Nonanedioic acid,
                                                                                hydraulic fluid for    bis(2-octyldodecyl)
                                                                                use in construction    ester
                                                                                equipment ie., bull
                                                                                dozers, cranes etc.
P-07-0082                            11/08/06                02/05/07                Cognis Corporation     (S) Biodegradable      (S) Decanedioic acid,
                                                                                hydraulic fluid for    bis(2-hexyldecyl)
                                                                                use in construction    ester
                                                                                equipment ie.,
                                                                                bullldozers, cranes
                                                                                etc.

P-07-0083                            11/08/06                02/05/07                Cognis Corporation     (S) Biodegradable      (S) Decanedioic acid,
                                                                                hydraulic fluid for    bis(2-octyldodecyl)
                                                                                use in construction    ester
                                                                                equipment ie.,
                                                                                bullldozers, cranes
                                                                                etc.
P-07-0084                            11/09/06                02/06/07                CBI                    (G) Open, non-         (G) Polyester polyol
                                                                                dispersive use
P-07-0085                            11/09/06                02/06/07                Cytec Surface          (G) Coatings resin     (G) Acrylated
                                                                                Specialties Inc.                              aliphatic
                                                                                polyurethane
P-07-0086                            11/09/06                02/06/07                CBI                    (G) Open, non-         (G) Water
                                                                                dispersive use         disperisible
                                                                                polyurethane
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 Notices Received From: 10/02/06 to 11/12/06
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Projected Notice End
              Case No.                    Received Date               Date           Manufacturer/Importer           Use                  Chemical
--------------------------------------------------------------------------------------------------------------------------------------------------------
T-07-0001                            11/09/06                12/23/06                Cytec Surface          (G) Coating resin      (G) Acrylated
                                                                                Specialties Inc.                              aliphatic
                                                                                polyurethane
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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. 57 Notices of Commencement From: 10/02/06 to 11/12/00
----------------------------------------------------------------------------------------------------------------
                                                                Commencement Notice
              Case No.                     Received Date             End Date                  Chemical
----------------------------------------------------------------------------------------------------------------
P-05-0484                             04/07/06                03/09/06                (G) Polyoxyethylene
                                                                                polyxoxypropylene
                                                                                polymer, reaction with
                                                                                cyclohexylmethane
                                                                                diisocyanate and
                                                                                polyoxyphenyl derivative
P-05-0551                             04/07/06                03/09/06                (G) Polyalkylene glycol
                                                                                alkyl ether, reaction
                                                                                products with allyl
                                                                                glycidyl ether
P-05-0694                             04/07/06                03/09/06                (G) Polyalkylene glycol
                                                                                aryl ether, reaction
                                                                                products with
                                                                                formaldehyde
P-06-0092                             04/07/06                03/09/06                (G) Oxirane,methyl-,
                                                                                polymer with oxirane,
                                                                                fatty acid alkyl ethers
J-05-0001                             10/03/06                08/14/06                (G) Trichoderma reesei
                                                                                3236
J-05-0002                             10/03/06                08/24/06                (G) Trichoderma reesei
                                                                                3243
J-06-0001                             10/03/06                08/11/06                (G) Trichoderma reesei
                                                                                3260
P-01-0084                             10/10/06                09/27/06                (G) 1,2,4,5-
                                                                                benzenetetracarboxylic
                                                                                acid, tetrakis esters
                                                                                with monohydric alcohols
P-01-0170                             10/05/06                09/12/06                (S) Acetic acid, [(5-
                                                                                chloro-8-quinolinyl)oxy-
                                                                                ], 1-methylhexyl ester
P-03-0273                             10/12/06                09/25/06                (G) Acrylic polymer
P-03-0664                             10/02/06                09/20/06                (G) Urethane acrylate
                                                                                resin
P-05-0740                             10/02/06                09/13/06                (G) Peroxyalkanoic acid
P-05-0742                             10/02/06                08/30/06                (G) Peroxyalkanoic acid
P-05-0743                             10/02/06                08/30/06                (G) Peroxyalkanoic acid
P-05-0744                             10/02/06                08/30/06                (G) Peroxyalkanoic acid
P-05-0745                             10/02/06                08/30/06                (G) Peroxyalkanoic acid
P-06-0039                             10/04/06                09/28/06                (G) Aqueous polyurethane
                                                                                dispersion
P-06-0131                             10/02/06                09/13/06                (S) Siloxanes and
                                                                                silicones, hydroxy me, 3-
                                                                                hydroxypropyl me, me (1-
                                                                                oxooctyl)oxy, esters with
                                                                                C12-20 fatty acids,
                                                                                ethers with polyethylene-
                                                                                polypropylene glycol mono-
                                                                                bu ether
P-06-0172                             10/02/06                09/08/06                (G) Fatty acid polymer
                                                                                with aliphatic diol and
                                                                                aromatic diacid
P-06-0317                             10/11/06                09/26/06                (G) Polycarbonate
                                                                                polyurethane
P-06-0318                             10/11/06                09/26/06                (G) Polycarbonate
                                                                                polyurethane resin
P-06-0320                             10/11/06                09/26/06                (G) Polyurethane
                                                                                dispersion
P-06-0386                             10/10/06                09/07/06                (S) 1,3-propanediol, 2-
                                                                                butyl-2-ethyl-, polymers
                                                                                with methylated
                                                                                formaldehyde-melamine
                                                                                polymer
P-06-0552                             10/11/06                09/21/06                (S)
                                                                                Tricyclo[<IP_ADDRESS>,11]hept
                                                                                asiloxane-3,7,14-triol,
                                                                                1,3,5,7,9,11,14-
                                                                                heptakis(2-methylpropyl)-
P-06-0626                             10/10/06                09/26/06                (G) Isocyanate functional
                                                                                polyester urethane
                                                                                polymer
P-02-0922                             10/25/06                09/30/06                (G) Urethane acrylate
                                                                                dispersion
P-03-0847                             10/31/06                10/25/06                (G) 14-carbon keto-alkyne
P-04-0920                             10/17/06                09/21/06                (G) Alkaryl sulfonic acid,
                                                                                metal salts
P-04-0925                             10/17/06                09/15/06                (G) Alkaryl sulfonic acid
P-04-0926                             10/17/06                09/15/06                (G) Alkaryl sulfonic acid
P-04-0930                             10/16/06                09/10/06                (G) Toluene alkylate
P-04-0931                             10/16/06                09/10/06                (G) Toluene alkylate

P-05-0127                             11/02/06                10/20/06                (G) Polymer of
                                                                                alkanepolyol, fatty acid
                                                                                derivative, and
                                                                                disubstituted benzenes
P-05-0557                             11/01/06                09/13/06                (G)
                                                                                Polyetherethersulfonesulf
                                                                                one block copolymer
P-06-0114                             10/20/06                09/21/06                (G) Alkaryl sulfonic acid,
                                                                                metal salts
P-06-0115                             10/20/06                09/21/06                (G) Alkaryl sulfonic acid,
                                                                                metal salts
P-06-0127                             10/25/06                09/18/06                (G) Modified butyl
                                                                                acrylate
P-06-0167                             11/03/06                10/16/06                (G) Substituted benzoic
                                                                                acid ester
P-06-0223                             11/06/06                10/19/06                (G) Heteromonocyclic, 2-
                                                                                mercapto-5,5-dimethyl-, 2-
                                                                                oxide
P-06-0238                             11/01/06                10/17/06                (S) Fatty acids, C18-
                                                                                unsatd., dimers,
                                                                                hydrogenated, polymers
                                                                                with adipic acid, 1,6-
                                                                                hexanediol, .alpha.-hydro-
                                                                                .omega.-hydroxypoly(oxy-
                                                                                1,4-butanediyl), 3-
                                                                                hydroxy-2-(hydroxymethyl)-
                                                                                2-methylpropanoic acid, 5-
                                                                                isocyanato-1-
                                                                                (isocyanatomethyl)-1, 3,3-
                                                                                trimethylcyclohexane, 2-
                                                                                methyl-1,5-pentanediamine
                                                                                and 2-oxepanone,
                                                                                compounds with
                                                                                triethylamine
P-06-0261                             11/02/06                10/05/06                (G) Alkylenediol, dialkyl-
                                                                                , polymer with
                                                                                isocyanato(isocyanatoalky
                                                                                l)trialkylcycloalkane,
                                                                                dipentaerythritol
                                                                                acrylate- and
                                                                                pentaerythritol acrylate-
                                                                                blocked, homopolymer
P-06-0283                             11/03/06                10/30/06                (G) Fatty acids, polymers
                                                                                with alkanoic acid, and
                                                                                epoxy resin
P-06-0284                             11/03/06                10/30/06                (G) Fatty acids, polymers
                                                                                with alkanoic acid and
                                                                                alkoxylated polyols
P-06-0289                             10/24/06                10/14/06                (G) Polyurethane urea
P-06-0313                             11/03/06                10/30/06                (G) Alkenoic acid modified
                                                                                vinylic copolymer
P-06-0346                             10/16/06                10/03/06                (G) Urethane modified
                                                                                polyamide
P-06-0510                             10/16/06                10/03/06                (G) Polyether modified
                                                                                polydimethylsiloxane
P-06-0511                             10/16/06                10/03/06                (G) Polyether modified
                                                                                polydimethylsiloxane
P-06-0540                             10/30/06                10/14/06                (G) Aliphatic polyester -
                                                                                polyether polyurethane
                                                                                dispersion
P-06-0548                             11/06/06                10/13/06                (G) Substituted
                                                                                trihalomethylpyridine
P-06-0590                             10/26/06                10/15/06                (G) Polyester polyol
P-06-0593                             10/17/06                10/10/06                (G) Aliphatic isocyanate
                                                                                resin
P-06-0599                             11/03/06                10/27/06                (G) Pmn substance b)
                                                                                aromatic substituted bis-
                                                                                dihydropyrrole monosodium
                                                                                salt; pmn substance c)
                                                                                aromatic substituted bis-
                                                                                dihydropyrrole disodium
                                                                                salt
P-06-0602                             10/23/06                09/22/06                (G) Silicone modified
                                                                                acrylic polymer
P-06-0612                             11/06/06                10/29/06                (G) Substituted
                                                                                carbohydrate
P-06-0644                             10/17/06                10/05/06                (S) Magnesium,
                                                                                bromo(pentafluorophenyl)-
P-95-1404                             10/30/06                10/14/06                (G) Unsaturated polyester
                                                                                resin
----------------------------------------------------------------------------------------------------------------

List of Subjects

    Environmental protection, Chemicals, Premanufacturer notices.

    Dated: December 7, 2006.
Bernice Mudd,
Acting Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. E6-21428 Filed 12-14-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 84, Number 123 (Wednesday, June 26, 2019)]
[Notices]
[Page 30111]
[FR Doc No: 2019-13559]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2012-0703; FRL-9995-07-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NESHAP for Prepared Feeds Manufacturing
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), NESHAP for Prepared Feeds
Manufacturing (EPA ICR Number 2354.05, OMB Control Number 2060-0635),
to the Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. This is a proposed
extension of the ICR, which is currently approved through June 30,
2019. Public comments were previously requested via the Federal
Register on May 30, 2018 during a 60-day comment period. This notice
allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An agency may neither conduct nor sponsor, and
a person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before July 26, 2019.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2012-0703, to: (1) EPA online using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW, Washington, DC 20460; and (2) OMB via email
to<EMAIL_ADDRESS>Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; 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, EPA West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) for Prepared Feeds Manufacturing were proposed on
July 27, 2009, promulgated on January 5, 2010, and amended on both July
20, 2010, and December 23, 2011. A prepared feed manufacturing facility
is a facility where animal feed (other than feed products for dogs and
cats) makes up at least half (by mass) of the facility's annual
production of all products. These regulations apply to new and existing
area source prepared feeds manufacturing facilities that use one or
more materials (additives/premixes) that contain 0.1 percent or greater
by weight of chromium (Cr) or 1.0 percent or greater by weight of
manganese (Mn). New facilities include those that commenced
construction or reconstruction after the date of proposal. This
information is being collected to assure compliance with 40 CFR part
63, subpart DDDDDDD.
    In general, all NESHAP standards require initial notifications,
performance tests, and periodic reports by the owners/operators of the
affected facilities. They are also required to maintain records of the
occurrence and duration of any startup, shutdown, or malfunction in the
operation of an affected facility, or any period during which the
monitoring system is inoperative. These notifications, reports, and
records are essential in determining compliance, and are required of
all affected facilities subject to NESHAP.
    Form Numbers: None.
    Respondents/affected entities: Prepared feed manufacturing
facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63).
    Estimated number of respondents: 1,800 (total).
    Frequency of response: Annual.
    Total estimated burden: 64,100 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $7,350,000 (per year), which includes $37,200
in annualized capital/startup and/or operation & maintenance costs.
    Changes in the Estimates: There is no change in the burden in this
ICR compared to the previous ICR. This is due to two considerations.
First, the regulations have not changed over the past three years and
are not anticipated to change over the next three years. Secondly, the
growth rate for the industry is very low, negative or non-existent, so
there is no significant change in the overall burden.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2019-13559 Filed 6-25-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 85 (Wednesday, May 3, 2023)]
[Notices]
[Pages 27901-27902]
[FR Doc No: 2023-09365]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-P-2060]

Determination That Levitra (Vardenafil Hydrochloride) Oral
Tablets, 5 Milligrams, 10 Milligrams, and 20 Milligrams, Were Not
Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that Levitra (vardenafil hydrochloride) oral tablets, 5
milligrams (mg), 10 mg, and 20 mg, were not withdrawn from sale for
reasons of safety or effectiveness. This determination means that FDA
will not begin procedures to withdraw approval of abbreviated new drug
applications (ANDAs) that refer to these drug products, and it will
allow FDA to continue to approve ANDAs that refer to these products as
long as they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Daniel Ritterbeck, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6219, Silver Spring, MD 20993-0002, 301-
796-4673, [email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
known generally as the ``Orange Book.'' Under FDA regulations, drugs
are removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg and 20
mg, are

the subject of NDA 021400, held by Bayer HealthCare Pharmaceuticals,
Inc., and initially approved on August 19, 2003. Levitra is a
phosphodiesterase 5 inhibitor indicated for the treatment of erectile
dysfunction.
    In letters dated September 26, 2019, September 24, 2020, and
September 20, 2021, Bayer HealthCare Pharmaceuticals, Inc. notified FDA
that Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg and
20 mg, respectively, were being discontinued, and FDA moved the drug
products to the ``Discontinued Drug Product List'' section of the
Orange Book.
    Respira Therapeutics, Inc. submitted a citizen petition dated
August 29, 2022 (Docket No. FDA-2022-P-2060), under 21 CFR 10.30,
requesting that the Agency determine whether Levitra (vardenafil
hydrochloride) oral tablets, 20 mg, were withdrawn from sale for
reasons of safety or effectiveness. Although the citizen petition did
not address the 5 mg and 10 mg strengths, those strengths have also
been discontinued. On our own initiative, we have also determined
whether those strengths were withdrawn for safety or effectiveness
reasons.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that Levitra (vardenafil hydrochloride) oral
tablets, 5 mg, 10 mg, and 20 mg, were not withdrawn for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that these drug products were withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of Levitra (vardenafil
hydrochloride) oral tablets, 5 mg, 10 mg, and 20 mg, from sale. We have
also independently evaluated relevant literature and data for possible
postmarketing adverse events. We have reviewed the available evidence
and determined that these drug products were not withdrawn from sale
for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list Levitra (vardenafil
hydrochloride) oral tablets, 5 mg, 10 mg, and 20 mg, in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. FDA will not begin procedures to withdraw
approval of approved ANDAs that refer to these drug products.
Additional ANDAs for these drug products may also be approved by the
Agency as long as they meet all other legal and regulatory requirements
for the approval of ANDAs. If FDA determines that labeling for these
drug products should be revised to meet current standards, the Agency
will advise ANDA applicants to submit such labeling.

    Dated: April 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09365 Filed 5-2-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: December 12, 2007 (Volume 72, Number 238)]
[Rules and Regulations]
[Page 70515-70516]
[DOCID:fr12de07-6]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[CGD08-07-042]
RIN 1625-AA09

Drawbridge Operating Regulation; Gulf Intracoastal Waterway
(Algiers Alternate Route), Belle Chasse, LA

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: The Coast Guard is changing the operating regulation for the
State Route 23 vertical lift bridge across the Gulf Intracoastal
Waterway (Algiers Alternate Route), mile 3.8, at Belle Chasse,
Louisiana. The portion of the existing regulation allowing the bridge
to remain closed to navigation on the last weekend in October is no
longer necessary and is being removed from the operating schedule.

DATES: This rule is effective on December 12, 2007.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket [CGD08-07-042] and are available for
inspection or copying at Eighth Coast Guard District, Bridge
Administration Branch, Hale Boggs Federal Building, Room 1313, 500
Poydras Street, New Orleans, Louisiana 70130-3310 between 7 a.m. and 3
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mr. David Frank, Bridge Administration
Branch, telephone number<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: We did not publish a notice of proposed
rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the
Coast Guard finds that good cause exists for not publishing an NPRM.
Public comment is not necessary since the event requiring the closure
has modified its schedule and the bridge closure no longer conforms to
the dates and times of the event.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective in less than 30 days after
publication in the Federal Register. There is no need to delay the
implementation of this rule because the portion of the regulation being
removed was date specific to the last weekend in October of each year.

Background and Purpose

    On October 11, 2001, a Final Rule was published in the Federal
Register [65 FR 60360] to change the operating schedule of the SR 23
vertical lift bridge across the Gulf Intracoastal Waterway (Algiers
Alternate Route), mile 3.8, in Belle Chasse, Louisiana. The change
allowed the drawbridge to not open for the passage of vessels from 4
p.m. to 7 p.m. on Saturday and Sunday of the last weekend in October.
This regulation was in addition to the existing regulation that
required the draw to open on signal; except that, from 6 a.m. to 8:30
a.m. and from 3:30 p.m. to 5:30 p.m. Monday through Friday, except
Federal holidays, the draw need not be opened from the passage of
vessels. The change was to facilitate the movement of vehicular traffic
from the New Orleans Open House Air Show held annually at the Naval Air
Station, Joint Reserve Base at Belle Chasse, Louisiana.
    Subsequent to the modification of the rule, the Air Show was
cancelled in 2005, moved to a different weekend in 2006, and the time
of the closure request was modified in 2007. The rule change for 2006
required a Temporary Rule to be published and the rule change for 2007
required a Temporary Deviation to be published. Additionally, the Air
Show will not be held in 2008 in Belle Chasse making the regulation
unnecessary. Therefore, it has been determined that the regulation be
modified to remove the requirements of Sec.  117.451(b)(2). Any future
closure requirements, associated with any future Air Shows in Belle
Chase, will be publicized as required by 33 CFR part 117, subpart A.

Discussion of Rule

    The Coast Guard is changing 33 CFR 117.451 without publishing an
NPRM. This final rule changes the regulation governing the bridge to
eliminate the section of the regulation that does not require the draw
to open for the passage of vessels from 4 p.m. to 7 p.m. on Saturday
and Sunday of the last weekend in October. This change improves the
ability of vessels to transit on the waterway during this time period.
As explained above, it is not necessary to publish an NPRM.

Regulatory Evaluation

    This rule is not a ``significant regulatory action'' under section
3(f) of Executive Order 12866, Regulatory Planning and Review, and does
not require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    The Coast Guard does not consider this rule to be ``significant''
under that Order because it does not adversely affect the owners and
operators of vessels operating on the waterway.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    This rule will have no impact on any small entities because it will
not adversely affect the owners and operators of vessels needing to
transit the waterway.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small
entities in understanding the rule so that they could better evaluate
its effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This final rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

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

Taking of Private Property

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

Civil Justice Reform

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

Protection of Children

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

Indian Tribal Governments

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

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Commandant Instruction M16475.lD
which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have
concluded that there are no factors in this case that would limit the
use of a categorical exclusion under section 2.B.2 of the Instruction.
Therefore, this rule is categorically excluded, under figure 2-1,
paragraph (32)(e) of the Instruction, from further environmental
documentation. Under figure 2-1, paragraph (32)(e), of the Instruction,
an ``Environmental Analysis Check List'' and a ``Categorical Exclusion
Determination'' are not required for this rule.

List of Subjects in 33 CFR Part 117

    Bridges.

0
For the reasons discussed out in the preamble, the Coast Guard amends
33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1(g); Department of
Homeland Security Delegation No. 0170.1.

0
2. Sec.  117.451(b) is revised to read as follows:

Sec.  117.451  Gulf Intracoastal Waterway.

* * * * *
    (b) The draw of the SR 23 bridge, Algiers Alternate Route, mile 3.8
at Belle Chasse, shall open on signal; except that, from 6 a.m. to 8:30
a.m. and from 3:30 p.m. to 5:30 p.m. Monday through Friday, except
Federal holidays, the draw need not be opened for the passage of
vessels.
* * * * *

    Dated: December 3, 2007.
J.R. Whitehead,
Rear Admiral, U.S. Coast Guard, Commander, Eighth Coast Guard District.
[FR Doc. E7-24050 Filed 12-11-07; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register: June 21, 2006 (Volume 71, Number 119)]
[Notices]
[Page 35637]
[DOCID:fr21jn06-71]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER06-857-000, ER06-857-001]

Energy Resource Management Corp.; Notice of Issuance of Order

June 14, 2006.
    Energy Resource Management Corp. (ERM) filed an application for
market-based rate authority, with an accompanying rate schedule. The
proposed market-based rate schedule provides for the sale of energy and
capacity at market-based rates. ERM also requested waiver of various
Commission regulations. In particular, ERM requested that the
Commission grant blanket approval under 18 CFR part 34 of all future
issuances of securities and assumptions of liability by ERM.
    On June 7, 2006, pursuant to delegated authority, the Director,
Division of Tariffs and Market Development--West, granted the request
for blanket approval under part 34. The Director's order also stated
that the Commission would publish a separate notice in the Federal
Register establishing a period of time for the filing of protests.
Accordingly, any person desiring to be heard or to protest the blanket
approval of issuances of securities or assumptions of liability by ERM
should file a motion to intervene or protest with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure. 18 CFR 385.211, 385.214 (2004).
    Notice is hereby given that the deadline for filing motions to
intervene or protest is July 6, 2006.
    Absent a request to be heard in opposition by the deadline above,
ERM is authorized to issue securities and assume obligations or
liabilities as a guarantor, indorser, surety, or otherwise in respect
of any security of another person; provided that such issuance or
assumption is for some lawful object within the corporate purposes of
ERM, compatible with the public interest, and is reasonably necessary
or appropriate for such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approval of ERM's issuances of securities or assumptions of
liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
field to access the document. Comments, protests, and interventions 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
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-9791 Filed 6-20-06; 8:45 am]

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[Federal Register Volume 84, Number 101 (Friday, May 24, 2019)]
[Notices]
[Page 24157]
[FR Doc No: 2019-10900]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1281]

General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of meeting of the General and Plastic Surgery
Devices Panel of the Medical Devices Advisory Committee. This meeting
was announced in the Federal Register of April 24, 2019. The amendment
is being made to reflect a change in the DATES portion of the document.
There are no other changes.

FOR FURTHER INFORMATION CONTACT: Patricio Garcia, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993, 301-796-
6875<EMAIL_ADDRESS>or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). Please call the Information Line for up-to-date information on
this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 24, 2019
(84 FR 17173), FDA announced that a meeting of the General and Plastic
Surgery Devices Panel of the Medical Devices Advisory Committee would
be held on May 30, 2019, from 10 a.m. to 4 p.m. On page 17173, in the
third column, in the DATES section, the sentence ``The meeting will be
held on May 30, 2019, from 10 a.m. to 4 p.m. and on May 31, 2019, from
8 a.m. to 4 p.m.'' is changed to read as follows:
    The meeting will be held on May 30, 2019, from 9 a.m. to 4 p.m. and
on May 31, 2019, from 8 a.m. to 4 p.m.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: May 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10900 Filed 5-23-19; 8:45 am]
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