[Federal Register: April 30, 2008 (Volume 73, Number 84)]
[Notices]
[Page 23455-23456]
[DOCID:fr30ap08-81]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. QM08-4-001]

Virginia Electric and Power Company; Notice of Filing

April 23, 2008.
    Take notice that on April 22, 2008, Virginia Electric and Power
Company filed a material amendment to its March

10, 2008, Application to Terminate Purchase Obligation. The amendment
is titled a motion for leave to file answer and answer to Smurfit Stone
Container Corporation's motion to intervene, limited protest and
comments. The amendment includes the net capacity of the potentially-
affected qualifying facilities. This information was missing from the
initial application.
    Because the filing constitutes a material amendment to the March
10, 2008, application filed by Virginia Electric and Power Company, the
90-day period within which the Commission must act on this application
begins on the date of the amended filing. The Commission will act on
the application on or before July 21, 2008, unless the application is
again materially amended.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on May 20, 2008.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-9432 Filed 4-29-08; 8:45 am]

BILLING CODE 6717-01-P


MEMORANDUM
DATE:		May 6, 2015
TO:	Dockets EPA-HQ-OAR-2013-0602, EPA-HQ-OAR-2013-0603, and EPA-HQ-OAR-2013-0495
FROM:	Lora Strine
SUBJECT:	Summary of Stakeholder Conference Call with RGGI States and EPA Staff
--------------------------------------------------------------------------------

SUMMARY
Discussion of 111(d) Clean Power Plan

ATTENDEES
Mike Gordon, EPA Region 3
Lora Strine, EPA
Shutsu Wong, EPA Region 1
Raymond Ford, EPA Region 2
                                     State
                                Representative
                                      CT
Jaimeson Sinclair, Keri Enright-Kato, Eric Annes, Dino Pascua
                                      DE
Valerie Gray
                                      ME
Erle Townsend, John Brautigam, Marc Cone
                                      MD
George (Tad) S. Aburn Jr., Scott Zacharko, Luke Wisniewski, Diane Franks
                                      MA
Rachel Evans, William Space, Bill Lamkin
                                      NH
Joe Fontaine, Karla McManus
                                      NY
Jim Austin, Allison Rose, Anthony Belsito , Dave Coup, Lois New, Jon Binder
                                      RI
Frank Stevenson, Dena Gonsalves
                                      VT
Brian Woods,  Megan O'Toole
                                  RGGI, Inc.
Lisa DeVito, Anna Ngai, Jiin Park, Nicole Singh


[Federal Register Volume 88, Number 181 (Wednesday, September 20, 2023)]
[Notices]
[Page 64908]
[FR Doc No: 2023-20352]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 6470-000]

Winooski Hydroelectric Company; Notice of Authorization for
Continued Project Operation

    The license for the Winooski 8 Hydroelectric Project No. 6470 was
issued for a period ending July 31, 2023.
    Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the
Commission, at the expiration of a license term, to issue from year-to-
year an annual license to the then licensee(s) under the terms and
conditions of the prior license until a new license is issued, or the
project is otherwise disposed of as provided in section 15 or any other
applicable section of the FPA. If the project's prior license waived
the applicability of section 15 of the FPA, then, based on section 9(b)
of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth
at 18 CFR 16.21(a), if the licensee of such project has filed an
application for a subsequent license, the licensee may continue to
operate the project in accordance with the terms and conditions of the
license after the minor or minor part license expires, until the
Commission acts on its application. If the licensee of such a project
has not filed an application for a subsequent license, then it may be
required, pursuant to 18 CFR 16.21(b), to continue project operations
until the Commission issues someone else a license for the project or
otherwise orders disposition of the project.
    If the project is subject to section 15 of the FPA, notice is
hereby given that an annual license for Project No. 6470 is issued to
Winooski Hydroelectric Company for a period effective August 1, 2023,
through July 31, 2024, or until the issuance of a new license for the
project or other disposition under the FPA, whichever comes first. If
issuance of a new license (or other disposition) does not take place on
or before July 31, 2024, notice is hereby given that, pursuant to 18
CFR 16.18(c), an annual license under section 15(a)(1) of the FPA is
renewed automatically without further order or notice by the
Commission, unless the Commission orders otherwise.
    If the project is not subject to section 15 of the FPA, notice is
hereby given that Winooski Hydroelectric Company is authorized to
continue operation of Winooski 8 Hydroelectric Project under the terms
and conditions of the prior license until the issuance of a new license
for the project or other disposition under the FPA, whichever comes
first.

    Dated: September 14, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-20352 Filed 9-19-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 8 (Friday, January 11, 2013)]
[Notices]
[Page 2382]
[FR Doc No: 2013-00401]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC13-58-000.
    Applicants: Blue Canyon Windpower LLC.
    Description: Application for Authorization for Disposition of
Jurisdictional Facilities and Request for Expedited Action of Blue
Canyon Windpower LLC.
    Filed Date: 1/2/13.
    Accession Number: 20130102-5143.
    Comments Due: 5 p.m. ET 1/23/13.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-1763-001; ER10-1764-001; ER10-1765-001; ER10-
1766-001; ER10-1767-001; ER10-1769-001; ER10-1642-003 ER10-1541-002.
    Applicants: Entergy Arkansas, Inc., Entergy Gulf States Louisiana,
L.L.C., Entergy Louisiana, LLC, Entergy Mississippi, Inc, Entergy
Texas, Inc., Entergy New Orleans, Inc., EWO Marketing, Inc., Entergy
Power, LLC.
    Description: Notice of Non-Material Change in Status of Entergy
Arkansas, Inc., et al.
    Filed Date: 12/31/12.
    Accession Number: 20121231-5242.
    Comments Due: 5 p.m. ET 1/22/13.

    Docket Numbers: ER12-569-002; ER12-775-001; ER10-1849-001; ER11-
2037-001; ER12-2227-002; ER10-1887-001; ER10-1920-003; ER10-1928-003;
ER10-1952-002; ER10-1961-001; ER12-1228-001; ER10-2720-003; ER11-4428-
003; ER12-1880-002; ER10-1971-010 .
    Applicants: Blackwell Wind, LLC, CPV Cimarron Renewable Energy
Company, LLC, Elk City Wind, LLC, Elk City II Wind, LLC, Ensign Wind,
LLC, FPL Energy Cowboy Wind, LLC, FPL Energy Oklahoma Wind, LLC, FPL
Energy Sooner Wind, LLC, Gray County Wind Energy, LLC, High Majestic
Wind Energy Center, LLC, High Majestic Wind II, LLC, Minco Wind, LLC,
Minco Wind II, LLC, Minco Wind III, LLC, NextEra Energy Power
Marketing, LLC.
    Description: NextEra Companies submit Triennial Market Power Update
for the Southwest Power Pool Region.
    Filed Date: 12/27/12.
    Accession Number: 20121227-5176.
    Comments Due: 5 p.m. ET 2/25/13.

    Docket Numbers: ER12-2627-001; ER10-2488-005; ER12-1931-002; ER10-
2504-003; ER12-610-003; ER13-338-001.
    Applicants: Catalina Solar, LLC, Oasis Power Partners, LLC, Pacific
Wind Lessee, LLC, Shiloh Wind Project 2, LLC, Shiloh III Lessee, LLC,
Shiloh IV Lessee, LLC.
    Description: Triennial Market Power Analysis Update of the EDF
Renewable Energy Inc. Southwest Region Companies.
    Filed Date: 12/31/12.
    Accession Number: 20121231-5255.
    Comments Due: 5 p.m. ET 3/1/13.

    Docket Numbers: ER13-690-000.
    Applicants: Public Service Company of New Mexico.
    Description: PNM Notice of Transmission Rate Change--Part 2 of 3 to
be effective 3/2/2013.
    Filed Date: 1/2/13.
    Accession Number: 20130102-5000.
    Comments Due: 5 p.m. ET 1/23/13.

    Docket Numbers: ER13-691-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Original Service Agreement No. 3452; Queue No. W3-106
to be effective 12/18/2012.
    Filed Date: 1/2/13.
    Accession Number: 20130102-5076.
    Comments Due: 5 p.m. ET 1/23/13.

    Take notice that the Commission received the following electric
reliability filings:

    Docket Numbers: RD13-3-000.
    Applicants: North American Electric Reliability Corporation.
    Description: Petition of the North American Electric Reliability
Corporation for Approval of Proposed Reliability Standard EOP-004-2--
Event Reporting.
    Filed Date: 12/31/12.
    Accession Number: 20121231-5233.
    Comments Due: 5 p.m. ET 1/30/13.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: January 2, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-00401 Filed 1-10-13; 8:45 am]
BILLING CODE 6717-01-P


Glyphosate Oxidoreductase and the Genetic Material Necessary for Its

Production in All Plants; Exemption From Tolerance Requirement On All Raw

Agricultural Commodities

[Federal Register: October 8, 1997 (Volume 62, Number 195)]

[Rules and Regulations]

[Page 52505-52509]

[DOCID:fr08oc97-12]

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

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300552; FRL-5745-2]

RIN 2070-AB78

Glyphosate Oxidoreductase and the Genetic Material Necessary for

Its Production in All Plants; Exemption From Tolerance Requirement On

All Raw Agricultural Commodities

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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SUMMARY:  This document establishes an exemption from the requirement

of a tolerance for residues of the plant-pesticide inert ingredients

glyphosate oxidoreductase (GOX) and the genetic material necessary for

its production in all plants when used as plant-pesticides in or on all

raw agricultural commodities (RACs). Monsanto Company submitted a

petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA)

as amended by the Food Quality Protection Act of l996 (FQPA) requesting

the exemption from the requirement of a tolerance. This regulation

eliminates the need to establish a maximum permissible level for

residues of this plant-pesticides in or on all RACS.

DATES:  This regulation is effective on October 8, 1997. Written

objections and requests for hearings must be received by EPA on or

before December 8, 1997.

ADDRESSES:  Written objections and hearing requests, identified by the

docket control number OPP-300552, may be submitted to: Hearing Clerk

(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees accompanying objections and hearing requests

shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA

Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O.

Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing

requests filed with the Hearing Clerk should be identified by the

docket control number OPP-300552 and submitted to: Public Information

and Records Integrity Branch, Information Resources and Services

Division (7506C), Office of Pesticide Programs, Environmental

Protection Agency, 401 M St., SW., Washington, DC 20460. In person,

bring a copy of objections and hearing requests to: Rm. 1132, Crystal

Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.

     A copy of objections and hearing requests filed with the Hearing

Clerk may also be submitted electronically by sending electronic mail

(e-mail) to:

<EMAIL_ADDRESS>     Copies of objections and hearing requests must be submitted as an

ASCII file avoiding the use of special characters and any form of

encryption. Copies of objections and hearing requests will also be

accepted on disks in WordPerfect in 5.1 file format or ASCII file

format. All copies of objections and hearing requests in electronic

form must be identified by the docket control number OPP-300552. No

Confidential Business Information (CBI) should be submitted through e-

mail. Additional information on CBI can be found in VII. of this

document. Electronic copies of objections and hearing requests on this

rule may be filed online at many Federal Depository Libraries.

Additional information on electronic submissions can be found in Unit

VIII. of this document.

FOR FURTHER INFORMATION CONTACT:  By mail: Mike Mendelsohn,

Biopesticides and Pollution Prevention Division, Office of Pesticide

Programs, Environmental Protection Agency, 401 M St., SW., Washington,

DC 20460. Office location, telephone number, and

e-mail address: 5th Floor Crystal Station, 2800 Crystal Drive,

Arlington, VA ,<PHONE_NUMBER>); e-mail: <EMAIL_ADDRESS> SUPPLEMENTARY INFORMATION:  In the Federal Register of January 24, 1997

(62 FR 3682) (FRL-5380-2), EPA issued a notice pursuant to section

408(d) of FFDCA, 21 U.S.C. 346a(d) announcing the filing of a pesticide

petition for an exemption from the requirement for a tolerance by

Monsanto Company, 700 Chesterfield Parkway, North St. Louis, MO 63198.

The notice contained a summary of the petition prepared by the

petitioner and this summary contained conclusions and arguments to

support its conclusion that the petition complied with the FQPA (Pub.

L. 104-170). The petition requested that an exemption from the

requirement of a tolerance be established for the plant-pesticides GOX

and the genetic material necessary for its production in plants in or

on all RACS. There were no comments or requests for referral to an

advisory committee received in response to the notice of filing. The

data submitted in the petition and other relevant material have been

evaluated. The toxicology and other data listed below were considered

in support of this exemption from the requirement of a tolerance.

I. Risk Assessment and Statutory Findings

    New section 408(c)(2)(A)(I) of FFDCA allows EPA to establish an

exemption from the requirement of a tolerance (the legal limit for a

pesticide chemical residue in or on a food) only if EPA determines that

the tolerance is ``safe'' to mean that ``there is a reasonable

certainty that no harm will result from aggregate exposure to the

pesticide chemical residue, including all anticipated dietary exposures

and all other exposures for which there is reliable information.'' This

includes exposure through drinking water and in residential settings,

but does not include occupational exposure. Section 408(c)(2)(B) of

FFDCA requires EPA to give special consideration to exposure of infants

and children to the pesticide chemical residue in establishing a

tolerance and to ``ensure that there is a reasonable certainty that no

harm will result to infants and children from aggregate exposure to the

pesticide chemical residue...'' EPA performs a number of analyses to

determine the risks from aggregate exposure to pesticide residues.

First, EPA determines the toxicity of pesticides. Second, EPA examines

exposure to the pesticide through food, drinking water, and through

other exposures that occur as a result of pesticide use in residential

settings.

II. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the

available scientific data and other relevant information in support of

this action and considered its validity, completeness, and reliablitiy

and the relationship of this information to human risk. EPA has

sufficient data to assess the hazards of glyphosate oxidoreductase

(GOX), and to make a determination on aggregate exposure, consistent

with section 408(c)(2) of FFDCA, for an exemption from the requirement

of a tolerance for residues GOX in or on all RACS. EPA's assessment of

the dietary exposures and risks associated with establishing the

exemption follows.

A. Toxicological Profile

    Glyphosate oxidoreductase (GOX) catalyzes the conversion of

glyphosate to aminomethylphosphonic acid (AMPA) and glyoxylate in a 1:1

stoichiometry while consuming \1/2\ mole of oxygen as a cosubstrate.

GOX requires flavin adenine dinucleotide (FAD) and magnesium for

activity; therefore, it is more appropriately designated an apoenzyme.

    The gene for Gox was originally isolated from Achromobacter sp.

Strain LBAA. The GOX protein was then sequenced and the gene was

synthesized with an added signal sequence and the codons modified in

the guanine and cytosine nucleic acid (GC) content to yield higher

plant expression. Two modified GOX proteins are specified in this rule.

They are designated GOX and GOXv247. Both versions have an identifier

of ``(M4-C1)'' in the data submissions which indicates that the protein

was expressed in E. coli for testing purposes. The GOX protein retains

the same amino acid sequence as the native protein and has additional

four amino acid sequence N-terminus (reminanats of an added signal

sequence). In GOXv247, the gene sequence of the native protein was

altered resulting in changes to three amino acids in the sequence of

the resulting protein along with the remains of the added signal

sequence mentioned previously. These changes did not negatively affect

the enzymatic activity of either protein.

    The GOX variants GOX and GOXv247, expressed in E. coli and

originating from the synthetic GOX gene optimized for protein

expression in plants, showed similarity to the native GOX protein when

expressed in E. coli. These similarities are seen as comparable

molecular weights, immunoreactivity, amino acid sequence and enzymatic

activity.

    The data submitted regarding potential health effects of GOX and

GOXv247 includes information on the characterization of the expression

of GOX in corn, the acute oral toxicity of GOX and GOXv247, and in

vitro digestibility studies of the proteins. The applicability of the

results of these studies to evaluate human risk and the validity,

completeness, and reliability of the available data from the studies

were considered.

    Both variants of the GOX protein (GOX and GOXv247) are rapidly

degraded in simulated gastric fluid (GF) and simulated intestinal fluid

(IF). After a fifteen-second incubation in GF, both variants have less

than 90% of their initial protein epitopes by western blot analysis.

Enzyme activity loss is also greater than 90% in both GOX variants when

assayed after a 1-minute incubation in GF. Similar results are seen in

simulated IF. Western blot assays show that both variants are greater

than 90% degraded by 30-second incubation in IF. However, the enzyme

activity assays show that the GOX activity lasts longer in IF than

variant GOXv247. After a 10-minute IF incubation, the activity

decreased to about 48% of initial for GOX whereas GOXv247 was already

greater than 90% inactive.

    Two findings, found in the in vitro digestibility studies, that are

remarkable are: GOXv247 displays a more rapid degradation in the IF

compared to unaltered GOX, apparently due to the single amino acid

substitutions; and antibody recognition is lost prior to a significant

loss of enzyme activity indicating that western blots may not always

accurately track functional protein degradation.

    None of the amino acid sequences of known allergens or proteins

involved in coeliac disease were shown to have similarity to the GOX

protein as defined by eight identical and contiguous amino acids in a

sequence. However, the assertion that a lack of allergenicity can be

established by comparison of sequences to known allergens is

questionable. While this is the best approximation at present, there is

no scientific basis to assume that the presence of eight contiguous and

homologous amino acids in a protein will predict its allergenicity. The

assumption is based on the finding that the presence of an eight amino

acid sequence in one allergen was associated with the epitope

responsible for IgE recognition. Alteration of this sequence

reduced IgE binding and hence allergenicity. The converse experiment,

to introduce the sequence into a non-allergenic protein and create an

allergen, has not been attempted experimentally.

    The acute oral toxicity test of bacterially-derived GOX and GOXv247

proteins showed no test substance related deaths at doses of 91.3

milligrams per kilogram (mg/kg) and 104 g/kg respectively.

Expression data on the GOX protein expressed in corn grains ranges from

undetectable levels to a high of 11.70 micro grams per gram (mg/g)

freshweight. This indicates that it would require 8,547 kg corn grain

per kg bodyweight to receive the 100 mg/kg dose that was administered

to the mice.

    However, residue chemistry data were not required for a human

health effects assessment of the subject plant-pesticide inert

ingredients because of the lack of mammalian toxicity. Both available

information concerning the dietary consumption patterns of consumers

(and major identifiable subgroups of consumers including infants and

children) and safety factors which, in the opinion of experts qualified

by scientific training and experience to evaluate the safety of food

additives, are generally recognized as appropriate for the use of

animal experimentation data were not evaluated because the lack of

mammalian toxicity at high levels of exposure demonstrate the safety of

the product at levels above possible maximum exposure levels. This is

similar to the Agency position regarding toxicity and the requirement

of residue data for the microbial Bacillus thuringiensis. [See 40 CFR

158.740(b).] For microbial products, further toxicity testing to verify

the observed effects and clarify the source of the effects (Tiers II

and III) and residue data are triggered by significant acute effects in

studies such as the mouse oral toxicity study.

    The acute oral toxicity data submitted support the prediction that

the GOX proteins would be non-toxic to humans. When proteins are toxic,

they are known to act via acute mechanisms and at very low dose levels

[Sjoblad, Roy D., et al. ``Toxicological Considerations for Protein

Components of Biological Pesticide Products,'' Regulatory Toxicology

and Pharmacology 15, 3-9 (1992)]. Therefore, since no effects were

shown to be caused by the plant-pesticides, even at relatively high

dose levels, the GOX protein is not considered toxic.

    Adequate information was submitted to show that the GOX test

materials derived from microbial cultures was biochemically and,

functionally similar to the proteins produced by the plant-pesticide

inert ingredient in corn. Production of microbially produced protein

was chosen in order to obtain sufficient material for testing. In

addition, the in vitro digestibility studies indicate the proteins

would be rapidly degraded following ingestion.

    The genetic material necessary for the production of the plant-

pesticides active and inert ingredients are the nucleic acids (DNA)

which comprise genetic material encoding these proteins and) their

regulatory regions. ``Regulatory regions'' are the genetic material

that control the expression of the genetic material encoding the

proteins, such as promoters, terminators, and enhancers. DNA is common

to all forms of plant and animal life and the Agency knows of no

instance where these nucleic acids have been associated with toxic

effects related to their consumption as a component of food. These

ubiquitous nucleic acids as they appear in the subject plant-pesticide

inert ingredient have been adequately characterized by the applicant.

Therefore, no mammalian toxicity is anticipated from dietary exposure

to the genetic material necessary for the production of the subject

active and inert plant pesticidal ingredients.

B. Sensitivity of Subgroups

    The Agency has considered available information on the variability

of the sensitivities of major identifiable subgroups of consumers

including infants and children and the physiological differences

between infants and children and adults and effects of in utero

exposure to the plant-pesticides. Since GOX is a protein, allergenic

sensitivities were considered. Current scientific knowledge suggests

that common food allergens tend to be resistant to degradation by heat,

acid, and proteases, are glycosylated and are present at high

concentrations in the food. Data has been submitted which demonstrate

that the GOX proteins are rapidly degraded by gastric fluid in vitro

and are non-glycosylated. Thus, the potential for the GOX proteins to

be a food allergens is minimal.

C. Cumulative Effects

     The Agency has considered available information on the cumulative

effects of such residues and other substances that have a common mode

toxicity. These considerations included the cumulative effects on

infants and children of such residues and other substances with a

common mechanism of toxicity. Because there is no indication of

mammalian toxicity to these plant-pesticides, there are no cumulative

effects.

D. Aggregate Exposures

     The Agency has considered available information on the aggregate

exposure levels of consumers (and major identifiable subgroups of

consumers) to the pesticide chemical residue and to other related

substances. These considerations include dietary exposure under the

tolerance exemption and all other tolerances or exemptions in effect

for the plant-pesticides chemical residue, and exposure from non-

occupational sources. Exposure via the skin or inhalation is not likely

since the plant-pesticides are contained within plant cells which

essentially eliminates these exposure routes or reduces these exposure

routes to negligible. Oral exposure, at very low levels, may occur from

ingestion of processed food products and drinking water. However a lack

of mammalian toxicity and the digestibility of the plant-pesticides has

been demonstrated. Regarding exposure via residential or lawn use to

infants and children, the Agency concludes that such exposure would

present no risk due to the lack of toxicity.

    Section 408 of FFDCA provides that EPA shall apply an additional

10-fold margin of exposure (MOE) (safety) for infants and children in

the case of threshold effects to account for pre- and post-natal

toxicity and the completeness of the database unless EPA determines

that a different MOE (safety) will be safe for infants and children. In

this instance EPA believes there is reliable data to support the

conclusion that the plant-pesticides are not toxic to mammals,

including infants and children, and thus there are no threshold effects

of concern. As a result, the provision requiring an additional MOE does

not apply.

III. Endocrine Effects

    EPA does not have any information regarding endocrine effects for

these kinds of pesticides at this time. The Agency is not requiring

information on the endocrine effects of these plant-pesticides at this

time; and Congress allowed 3 years after August 3, 1996, for the Agency

to implement a screening and testing program with respect to endocrine

effects.

IV. Analytical Method

    The Agency is establishing an exemption from the requirement of a

tolerance without numerical limitation; therefore, it has concluded

that an analytical method is not required for enforcement purposes for

GOX and the genetic material necessary for their production.

V. Conclusion

     There is a reasonable certainty that no harm will result from

aggregate exposure to the U.S. population, including infants and

children, to the GOX protein and the genetic material necessary for

that production. This includes all anticipated dietary exposures and

all other exposures for which there is reliable information. The Agency

has arrived at this conclusion because, as discussed above, no toxicity

to mammals has been observed for the plant-pesticides. As a result, EPA

establishes an exemption from tolerance requirements pursuant to

section 408(j)(3) of FFDCA for GOX and the genetic material necessary

for their production in all plants.

     Glyphosate Oxidoreductase [GOX or GOXv247] and the genetic

material necessary for its production in all plants are exempt from the

requirement of a tolerance when used as plant-pesticide inert

ingredients in all plant RACs. ``Genetic material necessary for its

production'' means the genetic material which comprise genetic material

encoding the GOX proteins and their regulatory regions. ``Regulatory

regions'' are the genetic material that control the expression of the

genetic material encoding the GOX proteins, such as promoters,

terminators, and enhancers.

VI. Objections and Hearing Requests

     The new FFDCA section 408(g) provides essentially the same process

for persons to ``object'' to a regulation for an exemption from the

requirement of a tolerance issued by EPA under new section 408(d) of

FFDCA as was provided in the old section 408 and in section 409 of

FFDCA. However, the period for filing objections is 60 days, rather

than 30 days. EPA currently has procedural regulations which governs

the submission of objections and hearing requests. These regulations

will require some modification to reflect the new law. However, until

those modifications can be made, EPA will continue to use those

procedural regulations with appropriate adjustments to reflect the new

law.

    Any person may, by December 8, 1997 file written objections to any

aspect of this regulation and may also request a hearing on those

objections. Objections and hearing requests must be filed with the

Hearing Clerk, at the address given under the ``ADDRESSES'' section (40

CFR 178.20). A copy of the objections and/or hearing requests filed

with the Hearing Clerk should be submitted to the OPP docket for this

rulemaking. The objections submitted must specify the provisions of the

regulation deemed objectionable and the grounds for the objections (40

CFR 178.25). Each objection must be accompanied by the fee prescribed

by 40 CFR 180.33(i). If a hearing is requested, the objections must

include a statement of the factual issue(s) on which a hearing is

requested, the requestor's contentions on such issues, and a summary of

any evidence relied upon by the objector (40 CFR 178.27). A request for

a hearing will be granted if the Administrator determines that the

material submitted shows the following: There is a genuine and

substantial issue of fact; there is a reasonable possibility that

available evidence identified by the requestor would, if established,

resolve one or more of such issues in favor of the requestor, taking

into account uncontested claims or facts to the contrary; and

resolution of the factual issue(s) in the manner sought by the

requestor would be adequate to justify the action requested (40 CFR

178.32).

VII. Confidential Business Information

    Information submitted in connection with an objection or hearing

request may be claimed confidential by marking any part or all of that

information as CBI. Information so marked will not be disclosed except

in accordance with procedures set forth in 40 CFR part 2. A copy not

contain CBI must be submitted for inclusion in the public record.

Information not marked confidential may be disclosed publicly by EPA

without prior notice.

VIII. Public Record and Electronic Submissions

    EPA has established a record for this rulemaking under docket

control number OPP-300552 (including any comments and data submitted

electronically). A public version of this record, including printed,

paperversions of electronic comments, which does not in include any

information claimed as CBI, is available for inspection from 8:30 a.m.

to 4 p.m., Monday through Friday, excluding legal holidays. The public

record is located in Room 1132 of the Public Information and Records

Integrity Branch, Information Resources and Services Division (7506C),

Office of Pesticide Programs, Environmental Protection Agency, Crystal

Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.

    Electronic comments may be sent directly to EPA at:

<EMAIL_ADDRESS>     Electronic comments must be submitted as an ASCII file avoiding the

use of special characters and any form of encryption.

     The official record for this rulemaking, as well as the public

version, as described above, will be kept in paper form. Accordingly,

EPA will transfer any copies of objections and hearing requests

received electronically into printed, paper form as they are received

and will place the paper copies in the official rulemaking record. The

official rulemaking record is the paper record maintained at the

Virginia address in ``ADDRESSES'' at the beginning of this document.

IX. Regulatory Assessment

    This final rule establishes an exemption from the tolerance

requirement under FFDCA section 408(d) in response to a petition

submitted to the Agency. The Office of Management and Budget (OMB) has

exempted these types of actions from review under Executive Order

12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,

1993). This final rule does not contain any information collections

subject to OMB approval under the Paperwork Reduction Act (PRA),

44U.S.C. 3501 et seq., or impose any enforceable duty or contain any

unfunded mandate as described under Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (P.L. 104-4). Nor does it require any prior

consultation as specified by Executive Order 12875, entitled Enhancing

the Intergovernmental Partnership (58 FR 58093, October 28, 1993), or

special considerations as required by Executive Order 12898, entitled

Federal Actions to Address Environmental Justice in Minority

Populations and Low-Income Populations (59 FR 7629, February 16, 1994),

or require OMB review in accordance with Executive Order 13045,

entitled Protection of Children from Environmental Health Risks and

Safety Risks (62 FR 19885, April 23, 1997).

    In addition, since tolerances and exemptions that are established

on the basis of a petition under FFDCA section 408(d), such as the

exemption in this final rule, do not require the issuance of a proposed

rule, the requirements of the Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency previously

assessed whether establishing tolerances, exemptions from tolerances,

raising tolerance levels or expanding exemptions might adversely impact

small entities and concluded, as a generic matter, that there is no

adverse economic impact. The factual basis for the Agency's generic

certification for tolerance actions published on May 4, 1981 (46 FR

24950), and was provided

to the Chief Counsel for Advocacy of the Small Business Administration.

X. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business

Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a

report containing this rule and other required information to the U.S.

Senate, the U.S. House of Representatives, and the Comptroller General

of the General Accounting Office prior to publication of this rule in

today's Federal Register. This is not a ``major rule'' as defined by 5

U.S.C. 804(2).

 List of Subjects in 40 CFR Part 180

     Environmental protection, Administrative practice and procedure,

Agricultural commodities, Pesticides and pests, Reporting and

recordkeeping requirements.

    Dated: September 25, 1997.

Stephen L. Johnson,

Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 346a and 371.

    2. Section 180.1190 is added to subpart D to read as follows:

Sec. 180.1190  Glyphosate Oxidoreductase [GOX or GOXv247] and the

genetic material necessary for its production in all plants; exemption

from the requirement of a tolerance.

     Glyphosate Oxidoreductase [GOX or GOXv247] and the genetic

material necessary for its production in all plants are exempt from the

requirement of a tolerance when used as plant-pesticide inert

ingredients in all plant RACs. Genetic material necessary for its

production means the genetic material which comprise genetic material

encoding the GOX proteins and their regulatory regions. Regulatory

regions are the genetic material that control the expression of the

genetic material encoding the GOX proteins, such as promoters,

terminators, and enhancers.

[FR Doc. 97-26190 Filed 10-7-97; 8:45 am]

BILLING CODE 6560-50-F


[Federal Register Volume 79, Number 46 (Monday, March 10, 2014)]
[Notices]
[Pages 13310-13311]
[FR Doc No: 2014-05062]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0199]

MK Laboratories, Inc., et al.; Proposal To Withdraw Approval of
Three Abbreviated New Drug Applications for Propoxyphene Products;
Opportunity for a Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA) Center for Drug
Evaluation and Research (CDER) is proposing to withdraw approval of
three abbreviated new drug applications (ANDAs) for propoxyphene drug
products from multiple sources and is announcing an opportunity for
holders of those ANDAs to request a hearing on this proposal.

DATES: Submit written requests for a hearing by April 9, 2014; submit
data and information in support of the hearing request by May 9, 2014.

ADDRESSES: Requests for a hearing, supporting data, and other comments
are to be identified with Docket No. FDA-2014-N-0199 and submitted to
the Division of Dockets Management, Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: David Joy, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6254, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Propoxyphene is an opioid pain relief
medication first approved by FDA in 1957. It has been marketed as a
single active ingredient drug product and in combination with other
active ingredients such as acetaminophen. It has been marketed under
brand names such as Darvon and Darvocet and in generic forms.
    After receiving clinical data and other information showing that
propoxyphene puts patients at risk of potentially serious and even
fatal heart rhythm abnormalities, FDA determined that the risks of
propoxyphene outweigh its benefits. On November 18, 2010, FDA asked
Xanodyne Pharmaceuticals, Inc. (Xanodyne), the maker of Darvon and
Darvocet, and manufacturers of then marketed generic propoxyphene drug
products to voluntarily withdraw their products from the U.S. market.
In a separate notice published elsewhere in this issue of the Federal
Register, FDA is withdrawing approval of 8 NDAs and 46 ANDAs from
multiple sources, whose application holders have agreed in writing to
permit FDA to withdraw approval of the applications and have waived
their opportunity for a hearing.
    Although the holders of the approved applications listed in Table 1
are believed to have discontinued marketing these products prior to
November 2010, FDA has not received correspondence from these
application holders requesting that the Agency withdraw approval of the
identified applications. Hence, in accordance with section 505(e) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)),
we hereby notify the application holders listed in Table 1 of their
opportunity to request a hearing on CDER's proposal to withdraw
approval of the listed applications.

 Table 1--Propoxyphene Drug Product Applications for Which FDA Proposes
                          To Withdraw Approval
------------------------------------------------------------------------
                                                         Applicant or
         Application No.                 Drug               holder
------------------------------------------------------------------------
ANDA 083544.....................  Kesso-Gesic         MK Laboratories
                                   (propoxyphene       Inc., 424
                                   hydrochloride       Grasmere Ave.,
                                   (HCl)) Capsules,    Fairfield, CT
                                   65 milligrams       06430.
                                   (mg).
ANDA 084551.....................  Propoxyphene HCl    Whiteworth Towne
                                   Capsules, 65 mg.    Paulsen Inc.
ANDA 084553.....................  Compound 65         Alra Labs, 3850
                                   (aspirin,           Clearview Ct.,
                                   caffeine, and       Gurnee, IL 60031.
                                   propoxyphene HCl)
                                   Capsules, 389 mg/
                                   32.4 mg/65 mg.
------------------------------------------------------------------------

I. Safety Concern

    NDAs 010996 and 010997 for propoxyphene HCl alone and in
combination with aspirin and caffeine, both held by Xanodyne, were
initially approved in 1957 solely on the basis of safety. The 1962
amendments to the FD&C Act required that drugs be shown to be effective
as well as safe. To implement the 1962 amendments, FDA initiated the
Drug Efficacy Study Implementation (DESI) review to evaluate the
effectiveness of drugs that had been previously approved on safety
grounds alone. In its DESI review of propoxyphene HCl; propoxyphene HCl
with aspirin; and propoxyphene HCl with aspirin, phenacetin, and
caffeine, FDA concluded that these drugs were effective for the relief
of mild to moderate pain (34 FR 6264, April 8, 1969).

    In January 2009, FDA held a joint meeting of the Anesthetic and
Life Support Drugs Advisory Committee and the Drug Safety and Risk
Management Advisory Committee to address the safety and efficacy of
propoxyphene and propoxyphene combination products for the treatment of
mild to moderate pain. The committee members voted 14 to 12 against the
continued marketing of propoxyphene products but noted that additional
information about the drug's cardiac effects would be relevant in
weighing its risks and benefits. Using authority under the Food and
Drug Administration Amendments Act of 2007 (Pub. L. 110-85), FDA
required Xanodyne to conduct a safety study of the effects of
propoxyphene on the heart at higher than recommended doses.
    Before proceeding with the cardiac safety study, the company first
conducted a study on healthy volunteers to determine an appropriate
dose. In this study, the healthy volunteers in one group were given a
total daily dose of 600 mg of propoxyphene (the maximum approved dose),
and volunteers in the second group were given a total daily dose of 900
mg (a dose higher than recommended in product labeling). The results
showed that there were significant changes to the electrical activity
of the heart (prolonged PR interval, widened QRS complex, and prolonged
QT interval), at both the 600 and 900 mg doses. These changes, which
can be seen on an electrocardiogram, can increase the risk for serious
abnormal heart rhythms. In light of these new scientific findings, CDER
determined the postmarketing safety signals for this drug have taken on
new importance, and the overall balance of risk and benefit can no
longer be considered favorable. Memoranda explaining CDER's
determination are available on FDA's Web site and will be placed in
Docket No. FDA-2014-N-0199 (Refs. 1 and 2).
    On November 19, 2010, FDA issued a Drug Safety Communication
recommending against the continued prescription and use of propoxyphene
drug products. This recommendation was based on all available data,
including the new data showing that when propoxyphene is taken at
therapeutic doses, it can cause significant changes to the electrical
activity of the heart. FDA has concluded that this safety risk
outweighs propoxyphene's benefits for pain relief at recommended doses.
Based on this information, FDA asked the manufacturers of currently
marketed propoxyphene products to voluntarily remove their products
from the market.
    Therefore, based on all available data, notice is given to the
holders of the approved applications listed in Table 1 and to all other
interested persons that the Director of CDER proposes to issue an
order, under section 505(e) of the FD&C Act, withdrawing approval of
the applications, amendments, and supplements upon the grounds that
scientific data show the listed drugs are unsafe under the conditions
of use for which they were approved.

II. Hearing Procedures

    In accordance with section 505(e) of the FD&C Act, the applicants
are hereby provided an opportunity to request a hearing to show why
approval of the applications listed in Table 1 should not be withdrawn
and an opportunity to raise, for administrative determination, all
issues relating to the legal status of the drug products covered by
these applications.
    An applicant who decides to seek a hearing must file the following:
(1) A written notice of participation and request for hearing (see
DATES) and (2) the data, information, and analyses relied on to
demonstrate that there is a genuine and substantial issue of fact that
requires a hearing to resolve (see DATES). Any other interested person
may also submit comments on this notice. The procedures and
requirements governing this notice of opportunity for a hearing, notice
of participation and request for a hearing, the information and
analyses to justify a hearing, other comments, and a grant or denial of
a hearing are contained in Sec.  314.200 (21 CFR 314.200) and in 21 CFR
part 12.
    The failure of an applicant to file a timely written notice of
participation and request for a hearing, as required by Sec.  314.200,
constitutes an election by that applicant not to avail itself of the
opportunity for a hearing concerning CDER's proposal to withdraw
approval of the applications and constitutes a waiver of any
contentions concerning the legal status of the drug products. FDA will
then withdraw approval of the applications, and the drug products may
not thereafter be lawfully introduced or delivered for introduction
into interstate commerce. Any new drug product introduced or delivered
for introduction into interstate commerce without an approved
application is subject to regulatory action at any time.
    A request for a hearing may not rest upon mere allegations or
denials, but must present specific facts showing that there is a
genuine and substantial issue of fact that requires a hearing. If a
request for a hearing is not complete or is not supported, the
Commissioner of Food and Drugs will enter summary judgment against the
person who requests the hearing, making findings and conclusions, and
denying a hearing.
    All submissions under this notice of opportunity for a hearing must
be filed in four copies. Except for data and information prohibited
from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the
submissions may be seen in the Division of Dockets Management (see
ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday, and will
be posted to the docket at http://www.regulations.gov.
    This notice is issued under section 505(e) of the FD&C Act and
under the authority delegated to the Director of CDER by the
Commissioner of Food and Drugs.

III. References

    FDA has placed the following references on display in the Division
of Dockets Management (see ADDRESSES). They may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday, and are
available electronically at http://www.regulations.gov.

    1. Memorandum to Dr. Woodcock: Recommendation on a Regulatory
Decision for Propoxyphene-Containing Products (November 18, 2010,
Hertz and Avigan); http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM234349.pdf.
    2. Memorandum to Dr. Woodcock on Propoxyphene-Containing
Products (November 18, 2010, Rappaport); http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM234340.pdf.

    Dated: March 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-05062 Filed 3-7-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: February 6, 2008 (Volume 73, Number 25)]
[Notices]
[Page 6950]
[DOCID:fr06fe08-36]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket Nos. ER08-314-000, ER08-314-001]

Bicent (California) Malburg, LLC; Notice of Issuance of Order

January 30, 2008.
    Bicent (California) Malburg, LLC (Bicent) filed an application for
market-based rate authority, with accompanying rate schedule. The
proposed market-based rate schedule provides for the sale of energy,
capacity and ancillary services at market-based rates. Bicent also
requested waivers of various Commission regulations. In particular,
Bicent requested that the Commission grant blanket approval under 18
CFR Part 34 of all future issuances of securities and assumptions of
liability by Bicent.
    On January 24, 2008, pursuant to delegated authority, the Director,
Division of Tariffs and Market Development-West, granted the requests
for blanket approval under Part 34 (Director's Order). 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 concerning the
blanket approvals of issuances of securities or assumptions of
liability by Bicent, should file a 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 (2007). The Commission
encourages the electronic submission of protests using the FERC Online
link at http://www.ferc.gov.

    Notice is hereby given that the deadline for filing protests is
February 25, 2008.
    Absent a request to be heard in opposition to such blanket
approvals by the deadline above, Bicent is authorized to issue
securities and assume obligations or liabilities as a guarantor,
endorser, 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 Bicent, 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 approvals of Bicent's issuance 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
filed 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.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-2116 Filed 2-5-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 79 (Wednesday, April 24, 2019)]
[Notices]
[Pages 17159-17160]
[FR Doc No: 2019-08307]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2013-0118; FRL-9992-68-OAR]

Proposed Information Collection Request; Comment Request; Control
of Evaporative Emissions From New and In-Use Portable Gasoline
Containers (Renewal), ICR 2213.06, OMB 2060-0597

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``Control of
Evaporative Emissions from New and In-Use Portable Gasoline Containers
(Renewal)'', ICR 2213.06,

OMB 2060-0597 to the Office of Management and Budget (OMB) for review
and approval in accordance with the Paperwork Reduction Act (44 U.S.C.
3501 et seq.). Before doing so, EPA is soliciting public comments on
specific aspects of the proposed information collection request as
described below. This notice is a proposed extension of the Portable
Fuel Container ICR, which is currently approved through September 30,
2019. 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 June 24, 2019.

ADDRESSES: Submit your comments, referencing the Docket ID No. EPA-HQ-
OAR-2013-0118, to the EPA: Online using www.regulations.gov (our
preferred method), or by mail to: EPA Docket Center, Environmental
Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW,
Washington, DC 20460.
    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: Julia Giuliano, Compliance Division,
Office of Transportation and Air Quality, U.S. Environmental Protection
Agency, 2000 Traverwood, Ann Arbor, Michigan 48105; telephone number:
734-214-4865; fax number<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting will be available in
the public docket, EPA-HQ-OAR-2013-0118, 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.
    Pursuant to section 3506(c)(2)(A) of the PRA, 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., permitting electronic submission of responses. 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, 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: EPA is required under Section 183(e) of the Clean Air Act
to regulate Volatile Organic Compound (VOC) emissions from the use of
consumer and commercial products. Under regulations promulgated on
February 26, 2007 (72 FR 8428) manufacturers of new portable gasoline
containers are required to obtain certificates of conformity with the
Clean Air Act, effective January 1, 2009. This ICR covers the burdens
associated with this certification process. EPA reviews information
submitted in a manufacturer's application for certification to
determine if the gasoline container design conforms to applicable
regulatory requirements and to verify that the required testing has
been performed. The certificate holder is required to keep records on
the testing and collect and keep warranty and defect information for
annual reporting on in-use performance of their products. The
respondent must also retain records on the units produced, apply serial
numbers to individual containers, and track the serial numbers to their
certificates of conformity. Any information submitted for which a claim
of confidentiality is made is safeguarded according to EPA regulations
at 40 CFR 2.201 et seq.
    Form Numbers: None.
    Respondents/affected entities: Manufacturers of new portable
gasoline containers from 0.25 to 10.0 gallons in capacity.
    Respondent's obligation to respond: Mandatory 40 CFR part 59,
subpart F.
    Estimated number of respondents: 8 (total).
    Frequency of response: Yearly for warranty reports; at least once
every five years for certificate renewals.
    Total estimated burden: 206.9 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $22,028.90 (per year), includes $12,552
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is a reduction of 43.1 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This decrease of the estimated burden and cost
estimates is due to a change in the estimated cost of labor and
additional testing requirements for new portable fuel container
families to comply with the requirements for evaporative testing
promulgated in 40 CFR part 59.

    Dated: April 17, 2019.
Byron Bunker,
Director, Compliance Division, Office of Transportation and Air
Quality, U.S. Environmental Protection Agency.
[FR Doc. 2019-08307 Filed 4-23-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 108 (Wednesday, June 7, 2017)]
[Notices]
[Page 26482]
[FR Doc No: 2017-11461]

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ENVIRONMENTAL PROTECTION AGENCY

[9961-40-Region 2]

Proposed CERCLA Cost Recovery Settlement for the Puerto Rico
Electric Power Authority Palo Seco Superfund Site, Toa Baja, Puerto
Rico

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; request for public comment.

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SUMMARY: In accordance with the Comprehensive Environmental Response,
Compensation, and Liability Act of 1980, as amended (``CERCLA''),
notice is hereby given by the U.S. Environmental Protection Agency
(``EPA''), Region 2, of a proposed cost recovery settlement agreement
pursuant to CERCLA, with the Puerto Rico Electric Power Authority
(``PREPA'') concerning the PREPA Palo Seco Superfund Site (``Site''),
located between Ensenada de Boca Vieja and San Juan Bay in Toa Baja,
Puerto Rico.

DATES: Comments must be submitted on or before July 7, 2017.

ADDRESSES: The proposed settlement is available for public inspection
at EPA Region 2 offices at 290 Broadway, New York, New York 10007-1866.
Comments should reference the PREPA Palo Seco Superfund Site, Toa Baja,
Puerto Rico, Index No. II-CERCLA-02-2017-2014. To request a copy of the
proposed settlement agreement, please contact the EPA employee
identified below.

FOR FURTHER INFORMATION CONTACT: Margo Ludmer, Assistant Regional
Counsel, New York/Caribbean Superfund Branch, Office of Regional
Counsel, U.S. Environmental Protection Agency, 290 Broadway, 17th
Floor, New York, NY 10007-1866. Email<EMAIL_ADDRESS>Telephone:
212-637-3187.

SUPPLEMENTARY INFORMATION: PREPA agrees to pay EPA $1,000,000.00, plus
an additional sum for interest, in reimbursement of EPA's past response
costs paid at or in connection with the Site. Payment is to be made in
three installments within two years and thirty days of the effective
date of the settlement agreement. The settlement includes a covenant by
EPA not to sue or to take administrative action against PREPA pursuant
to Section 107(a) of CERCLA, 42 U.S.C. 9607(a), with regard to the
response costs related to the work at the Site enumerated in the
settlement agreement.
    For thirty (30) days following the date of publication of this
notice, EPA will receive written comments relating to the settlement.
EPA will consider all comments received and may modify or withdraw its
consent to the settlement if comments received disclose facts or
considerations that indicate that the proposed settlement is
inappropriate, improper, or inadequate.
    EPA's response to any comments received will be available for
public inspection at EPA Region 2, 290 Broadway, New York, New York
10007-1866.

    Dated: March 8, 2017.
John Prince,
Acting Director, Emergency and Remedial Response Division, U.S.
Environmental Protection Agency, Region 2.
[FR Doc. 2017-11461 Filed 6-6-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: July 21, 2008 (Volume 73, Number 140)]
[Notices]
[Page 42360-42361]
[DOCID:fr21jy08-59]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1774-DR]

South Dakota; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of South Dakota (FEMA-1774-DR), dated July 9,
2008, and related determinations.

DATES: Effective Date: July 9, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated July 9, 2008, the President declared a major disaster under the
authority of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows:

    I have determined that the damage in certain areas of the State
of South Dakota resulting from severe storms and flooding during the
period of June 2-12, 2008, is of sufficient severity and magnitude
to warrant a major disaster declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206
(the Stafford Act). Therefore, I declare that such a major disaster
exists in the State of South Dakota.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas, Hazard Mitigation throughout the State, and any
other forms of assistance under the Stafford Act that you deem
appropriate. Consistent with the requirement that Federal assistance
be supplemental, any Federal funds provided under the Stafford Act
for Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, except for any particular projects that are eligible
for a higher Federal cost-sharing percentage under the FEMA Public
Assistance Pilot Program instituted pursuant to 6 U.S.C. 777. If
Other Needs Assistance under Section 408 of the Stafford Act is
later warranted, Federal funding under that program also will be
limited to 75 percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
to the extent allowable under the Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Tony Russell, of FEMA is appointed
to act as the Federal Coordinating Officer for this declared disaster.
    The following areas of the State of South Dakota have been
designated as adversely affected by this declared major disaster:

    The counties of Aurora, Bon Homme, Brule, Buffalo, Butte,
Charles Mix, Clay, Dewey, Douglas, Gregory, Haakon, Hand, Hanson,
Hughes, Hutchinson, Jackson, Lawrence, Lyman McCook, Meade,
Mellette, Moody, Perkins, Stanley, Tripp, Turner, and Ziebach and
the portions of the Cheyenne River Reservation, the Crow Creek
Reservation, and the Lower Brule Reservation that lie within the
designated counties for Public Assistance.
    All counties and Tribal Reservations in the State of South
Dakota are eligible to apply for assistance under the Hazard
Mitigation Grant Program.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidential Declared Disaster Areas; 97.049, Presidential Declared
Disaster Assistance--Disaster Housing Operations for Individuals and
Households; 97.050, Presidential Declared Disaster Assistance to
Individuals and Households--Other Needs; 97.036, Disaster

Grants--Public Assistance (Presidentially Declared Disasters);
97.039, Hazard Mitigation Grant.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-16557 Filed 7-18-08; 8:45 am]

BILLING CODE 9110-10-P


[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)]
[Notices]
[Pages 51254-51255]
[FR Doc No: 2015-20786]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-0269; FRL 9929-63-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Transportation Conformity Determinations for
Federally Funded and Approved Transportation Plans, Programs and
Projects (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``Transportation Conformity
Determinations for Federally Funded and Approved Transportation Plans,
Programs and Projects (Renewal)'' (EPA ICR No. 2130.05, OMB Control No.
2060-0561) to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.). This is a proposed extension of the ICR, which is approved
through August 31, 2015. Public comments were previously requested via
the Federal Register (80 FR 9454) on February 23, 2015 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.

DATES: Additional comments may be submitted on or before September 23,
2015.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2007-0269, to (1) EPA online using www.regulations.gov (our
preferred method) 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: Astrid Larsen, Transportation and
Climate Division, State Measures and Transportation Planning Center,
Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI
48105; 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, WJC West, Room 3334, 1301 Constitution
Ave. NW., Washington, DC. The telephone number for the Docket Center is
202-566-1744. For additional information about EPA's public docket,
visit http://www.epa.gov/dockets.
    Abstract: Transportation conformity is required under Clean Air Act
section 176(c) (42 U.S.C. 7506(c)) to ensure that federally supported
transportation activities are consistent with the purpose of the State
Air Quality Implementation plan (SIP). Transportation activities
include transportation plans, Transportation Improvement Programs
(TIPs), and federally funded or approved highway or transit projects.
Conformity to the purpose of the SIP means that transportation
activities will not cause or contribute to new air quality violations,
worsen existing violations, or delay timely attainment of the relevant
National Ambient Air Quality Standards (NAAQS) or interim milestones.
Transportation conformity applies under EPA's conformity regulations at

40 CFR part 93, subpart A, to areas that are designated
nonattainmentand to those redesignated to attainment after 1990 for the
following transportation-related criteria pollutants: Ozone,
particulate matter (PM2.5 and PM10), carbon
monoxide (CO), and nitrogen dioxide (NO2). The EPA published
the original transportation conformity rule on November 24, 1993 (58 FR
62188), and subsequently published several revisions. EPA develops the
conformity regulations in coordination with the Federal Highway
Administration (FHWA) and Federal Transit Administration (FTA). The
federal government needs information collected under these regulations
to ensure that metropolitan planning organization (MPO) and federal
transportation actions are consistent with state air quality goals.
    Form Numbers: None.
    Respondents/affected entities: Metropolitan Planning Organizations
(MPOs), local transit agencies, state departments of transportation,
and state and local air quality agencies.
    Respondent's obligation to respond: Mandatory (Clean Air Act
section 176(c) ((42 U.S.C. 7506(c)) and 40 CFR parts 51 and 93).
    Estimated number of respondents: 126 (total).
    Frequency of response: Annually, occasionally.
    Total estimated burden: 60,548 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $3,596,553 (per year), includes zero
annualized capital or operation & maintenance costs.
    Changes in the estimates: There is a decrease of 27,856 hours in
the total estimated respondent burden compared with the ICR currently
approved by OMB. This decrease is due to an adjustment in project level
conformity, decreased transportation conformity analysis, and a
transition from MOVES2010 to MOVES 2014.

Courtney Kerwin,
Acting Director, Collection Strategies Division.
[FR Doc. 2015-20786 Filed 8-21-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Notices]
[Pages 72980-72982]
[FR Doc No: 2011-30478]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2011-0197]

Occupational Safety and Health State Plans; Extension of the
Office of Management and Budget's (OMB) Approval of Information
Collection (Paperwork) Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comments.

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

SUMMARY: OSHA solicits public comments concerning its request for an
extension of the Office of Management and Budget's (OMB) approval of
the information collection requirements associated with its regulations
and program regarding State Plans for the development and enforcement
of state occupational safety and health standards (29 CFR Parts 1902,
1952, 1953, 1954, 1955, 1956).

DATES: Comments must be submitted (postmarked, sent, or received) by
January 27, 2012.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit a copy of your comments and
attachments to the OSHA Docket Office, Docket No. OSHA-2011-0197, U.S.
Department of Labor, Occupational Safety and Health Administration,
Room N-2625, 200 Constitution Avenue NW, Washington, DC 20210.
Deliveries (hand, express mail, messenger, and courier service) are
accepted during the Department of Labor's and Docket Office's normal
business hours, 8:15 a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and OSHA
docket number for the Information Collection Request (ICR) (OSHA-2011-
0197). All comments, including any personal information you provide,
are placed in the public docket without change and may be made
available online at http://www.regulations.gov. For further information
on submitting comments, see the ``Public Participation'' heading in the
section of this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download from the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Laura Seeman at
the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Laura Seeman, Directorate of
Cooperative and State Programs, Office of State Programs, Occupational
Safety and Health Administration, U.S. Department of Labor, Room N-
3700, 200 Constitution Avenue NW, Washington, DC 20210; telephone:
(202) 693-2244; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., the 27 States with OSHA-approved State
Plans) burden, conducts a preclearance consultation program to provide
the public with an opportunity to comment on proposed and continuing
information collection requirements in accordance with the Paperwork
Reduction Act of 1995 (PRA 95) (44 U.S.C. 3506(c)(2)(A)). This program
ensures that information is in

the desired format, reporting burden (time and cost) is minimized,
collection instruments are understandable, and OSHA's estimate of the
information collection burden is accurate. Currently, OSHA is
soliciting comments concerning the extension of the information
collection requirements contained in the series of regulations
establishing requirements for the submission, initial approval,
continuing approval, final approval, monitoring and evaluation of OSHA-
approved State Plans:
     29 CFR part 1902, State Plans for the Development and
Enforcement of State Standards;
     29 CFR part 1952, Approved State Plans for Enforcement of
State Standards;
     29 CFR part 1953, Changes to State Plans for the
Development and Enforcement of State Standards;
     29 CFR part 1954, Procedures for the Evaluation and
Monitoring of Approved State Plans;
     29 CFR part 1955, Procedures for Withdrawal of Approval of
State Plans; and
     29 CFR part 1956, State Plans for the Development and
Enforcement of State Standards Applicable to State and Local Government
Employees in States without Approved Private Employee Plans.
    Section 18 of the Occupational Safety and Health Act (29 U.S.C.
667) offers an opportunity to the states to assume responsibility for
the development and enforcement of state standards through the
mechanism of an OSHA-approved State Plan. Absent an approved plan,
states are precluded from enforcing occupational safety and health
standards in the private sector with respect to any issue for which
Federal OSHA has promulgated a standard. Once approved and operational,
the state adopts standards and provides most occupational safety and
health enforcement and compliance assistance in the state, under the
authority of its plan, instead of Federal OSHA. States also must extend
their jurisdiction to cover state and local government employees and
may obtain approval of State Plans limited in scope to these workers.
To obtain and maintain State Plan approval, a state must submit various
documents to OSHA describing its program structure and operation,
including any modifications thereto as they occur, in accordance with
the identified regulations. OSHA funds 50 percent of the costs required
to be incurred by an approved State Plan with the state at least
matching and providing additional funding at its discretion.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on participating states who
must comply; for example, by using automated or other technological
information collection and transmission techniques.

III. Proposed Actions

    OSHA is requesting that OMB extend its approval of the collection
of information requirements associated with its State Plan regulations.
In doing so, the Agency is proposing to increase the burden hours from
10,652 to 11,196 hours. The increase is a result of the approval of the
Illinois Public Employee Only State Plan, increasing the number of
approved State Plan respondents from 26 to 27, and an increase in the
projected number of required State Plan responses and modifications as
a result of changes in federal procedures. The total number of
respondents increased to 28, including the 27 approved State Plans and
one state developing a plan to seek State Plan approval. The Agency
will summarize the comments submitted in response to this notice and
will include this summary in its request to OMB.
    Type of Review: Extension of a currently approved collection.
    Title: Occupational Safety and Health State Plans.
    OMB Number: 1218-0247.
    Affected Public: Designated state government agencies that are
seeking or have submitted and obtained approval for State Plans for the
development and enforcement of occupational safety and health
standards.
    Number of Respondents: 28.
    Frequency: On occasion; quarterly; annually.
    Total Responses: 1,264.
    Average Time per Response: Varies from 30 minutes (.5 hour) to
respond to an information inquiry to 80 hours to document state annual
performance goals.
    Estimated Total Burden Hours: 11,196.
    Estimated Cost (Operation and Maintenance): $0.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number for the ICR (Docket No. OSHA-2011-0197). You
may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify your electronic comments
by your name, date, and the OSHA docket number, so the Agency can
attach them to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information, such as social security numbers and
dates of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download through this
Web site. All submissions, including copyrighted material, are
available for inspection and copying at the OSHA Docket Office.
Information on using the http://www.regulations.gov Web site to submit
comments and access the docket is available at the Web site's ``User
Tips'' link. Contact the OSHA Docket Office for information about
materials not available through the Web site and for assistance in
using the Internet to locate docket submissions.

V. Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506 et seq.) and Secretary of

Labor's Order No. 5-2010 (75 FR 55355).

    Signed at Washington, DC, on November 22, 2011.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2011-30478 Filed 11-25-11; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register: December 29, 2008 (Volume 73, Number 249)]
[Rules and Regulations]
[Page 79313]
[DOCID:fr29de08-5]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-0716; Airspace Docket No. 08-ASW-9]

Establishment of Low Altitude Area Navigation T-254; Houston, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; delay of effective date.

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

SUMMARY: This action delays the effective date for the establishment of
the low altitude Area Navigation (RNAV) T-route, designated T-254, in
the vicinity of the Houston, TX, terminal area until March 12, 2009.
The FAA is taking this action to allow additional time for processing
and charting.

DATES: Effective Date: 0901 UTC. The effective date of January 15,
2009, is delayed to March 12, 2009. The Director of the Federal
Register approves this incorporation by reference action under 1 CFR
part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace and Rules
Group, Office of System Operations Airspace and AIM, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On November 18, 2008, the FAA published in the Federal Register a
final rule establishing the low altitude RNAV route T-254, in the
vicinity of the Houston, TX, terminal area (73 FR 68317). This rule was
originally scheduled to become effective January 15, 2009; however, a
need for additional internal processing requires a delay in the
effective date until March 12, 2009.

The Rule

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under Department of Transportation (DOT) Regulatory Policies and
Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant
preparation of a regulatory evaluation as the anticipated impact is so
minimal. Since this is a routine matter that will only affect air
traffic procedures and air navigation, it is certified that this rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes an RNAV T-Route in the vicinity of Houston, TX.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Delay of Effective Date

0
The effective date of the final rule, Docket FAA-2008-0716; Airspace
Docket 08-ASW-9, as published in the Federal Register on November 18,
2008 (73 FR 68317), is hereby delayed until March 12, 2009.

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
* * * * *

    Issued in Washington, DC, on December 12, 2008.
Edith V. Parish,
Manager, Airspace and Rules Group.
 [FR Doc. E8-30635 Filed 12-24-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: July 9, 2009 (Volume 74, Number 130)]
[Notices]
[Page 33011-33012]
[DOCID:fr09jy09-138]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60205; File No. SR-NYSEArca-2009-60]

 Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Amending Its
Schedule of Fees and Charges for Exchange Services

July 1, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on June 29, 2009, the NYSE Arca Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C.78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend its Schedule of Fees and Charges for
Exchange Services in order to extend until December 31, 2009 the
current pilot program regarding transaction fees charged for trades
executed through the intermarket options linkage (``Linkage''). The
text of the proposed rule change is available at the Exchange, the
Commission's Public Reference Room and www.nyse.com.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of those statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant parts of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of this proposed rule change is to extend the pilot
program establishing an NYSE Arca fee for Principal (``P'') Orders and
Principal Acting as Agent (``P/A'') Orders executed through Linkage.
The fee currently is effective for a pilot program set to expire on
July 31, 2009, and this filing would extend the fee through December
31, 2009. The fee that NYSE Arca charges for P and P/A orders is the
basic execution fee for trading on NYSE Arca. This is the same fee that
all NYSE Arca Option Trading Permit Holders pay for non-customer
transactions executed on the Exchange. The Exchange does not charge for
the execution of Satisfaction Orders sent through Linkage and is not
proposing to charge for such orders. The Exchange is making no
substantive changes to the operation of the pilot program, other than
extending the pilot program through December 31, 2009.
    The Exchange also proposes to revise the Linkage Fees portion of
the Schedule, so as to delete the fee for manually executed orders. The
Exchange does not manually execute orders via Linkage. All Linkage
orders are executed electronically. Deleting this reference from the
Schedule will more accurately reflect the way Linkage orders are
executed.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) of the Act \3\, in general, and with Section 6(b)(4) \4\
of the Act in particular, in that it is designed to provide for the
equitable allocation of reasonable dues, fees, and other charges among
its members and other persons using its facilities for the purpose of
executing P and P/A orders through Linkage.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change: (i) Does not
significantly affect the protection of investors or the public
interest; (ii) does not impose any significant burden on competition;
and (iii) by its terms, does not become operative for 30 days from the
date on which it was filed, or such shorter time as the Commission may
designate, if consistent with the protection of investors and the
public interest, it has become effective pursuant to Section
19(b)(3)(A) of the Act \5\ and Rule 19b-4(f)(6) thereunder.\6\
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(3)(A).
    \6\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the self-regulatory organization to submit to the
Commission written notice of its intent to file the proposed rule
change, along with a brief description and text of the proposed rule
change, at least five business days prior to the date of filing of
the proposed rule change, or such shorter time as designated by the
Commission. The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2009-60 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEArca-2009-60. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEArca-2009-60 and should
be submitted on or before July 30, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. E9-16175 Filed 7-8-09; 8:45 am]

BILLING CODE 8010-01-P