Fenamiphos Fact Sheet – June 2008 Update

EPA 738-F-08- 005

June 2008

EPA assessed the risks of fenamiphos and completed an Interim
Reregistration Eligibility Decision (IRED) document for this
organophosphate (OP) pesticide in 2002. The IRED identified risk
mitigation measures needed to reduce risk, as well as data needed to
better characterize risks. The sole registrant, Bayer Corporation,
requested voluntary cancellation and phase-out of all existing
fenamiphos registrations rather than committing to develop additional
data.  EPA approved this request.

Used on a variety of vegetables and fruits, fenamiphos residues in food
do not pose risk concerns.  However, exposure to drinking water sources
from shallow water tables (less than 50 feet deep) and extremely
vulnerable soils do pose risk concerns.  Extremely vulnerable soils are
defined as, "hydrologic soil group A soils that are excessively drained
and predominantly sand or loamy sand, such as soils in the suborder
psamments."  These classifications and soil taxonomy refer to USDA
definitions.  Therefore, all uses of fenamiphos in areas with extremely
vulnerable soils and shallow water tables were phased out by May 31,
2005.

Fenamiphos is not used in residential settings. It is, however, used on
turf including golf course turf, which could lead to golfer exposure
from residues on treated courses. Nevertheless, the Agency believes that
the watering-in of fenamiphos adequately protects golfers.
Implementation of risk mitigation during the phase out, negotiated
between the registrant and the Agency, is believed to decrease the risks
associated with fenamiphos.

EPA has considered available information on the cumulative risk of the
OP pesticides, which share a common mechanism of toxicity, as required
by the Food Quality Protection Act (FQPA).  The tolerance reassessment
decision for fenamiphos has been proposed in a Federal Register notice
dated February 6, 2008 (FRL-8345-2).  This notice proposes that all
domestic tolerances are to be revoked by December 31, 2009.  The notice
also proposes that several commodities treated with fenamiphos will
continue to have import tolerances:  banana; fruit, citrus, group 10;
garlic; grape; and pineapple.

The fenamiphos decision was made through the OP pilot public
participation process, which increases transparency and maximizes
stakeholder involvement in EPA's development of risk assessments and
risk management decisions. EPA worked extensively with affected parties
to reach the decisions presented in the IRED document. The agreement on
the voluntary cancellation, based on the registrant's decision not to
develop data that were an essential part of the risk mitigation
proposal, concludes the Agency’s reregistration review of fenamiphos.

Uses

A nematicide and an insecticide, fenamiphos has been used primarily to
control nematodes and thrips on various agricultural crops (i.e.,
citrus, grapes, peanuts, pineapples, tobacco, etc.) and non-agricultural
(i.e., turf and ornamentals) sites.  Additionally, all uses have been
soil incorporated, except for the pineapple use. There are no
residential uses for fenamiphos.

Annual domestic use was low-- approximately 780,000 pounds of active
ingredient per year.

Fenamiphos is a Restricted Use Pesticide (RUP) due to high acute
toxicity and toxicity to wildlife.

Health Effects

Fenamiphos can cause cholinesterase inhibition in humans; that is, it
can overstimulate the nervous system causing nausea, dizziness,
confusion, and at very high exposures (e.g., accidents or major spills),
respiratory paralysis and death.

Risks

Dietary (acute and chronic) exposures from eating commodities treated
with fenamiphos are below the Agency's level of concern for the entire
U.S. population, including infants and children.

Dietary (drinking water) exposures are generally not of concern for
surface and ground water sources in soils that are not extremely
vulnerable. However, exposure to shallow ground water sources of
drinking water associated with soils that are extremely vulnerable
exceed the Agency's level of concern.

EPA has risk concerns for workers who mix, load, and/or apply fenamiphos
to agricultural sites and golf courses.

Acute and chronic risks exceed the Agency's level of concern for
terrestrial, aquatic, and endangered species.

Risk Mitigation

The registrant requested voluntary cancellation of existing fenamiphos
product registrations with a 5-year phase out.  A Use Deletion and
Product Cancellation Order (FRL-7332-5) (68 FR 68901) for fenamiphos was
published in the Federal Register on December 10, 2003, announcing that
EPA granted the registrant’s request.

The registrant agreed to cancel use, and formulation for use, of all of
its existing fenamiphos registrations in areas with extremely vulnerable
soils and shallow water tables effective May 31, 2005.

The registrant agreed to produce no more than 500,000 pounds of
fenamiphos manufacturing use products for use in the United States
during the first year of the phase out which ended May 31, 2003. In each
subsequent year of the 5-year phase out, production was reduced by 20%
of the previous year's production.

All fenamiphos product registrations were cancelled and sale and
distribution of manufacturing and end-use products by the registrant
were prohibited effective May 31, 2007.

Sale and distribution of all existing stocks by persons other than the
registrant were to be prohibited effective May 31, 2008.  However, as
announced in an Amendment to Use Deletion and Product Cancellation Order
published in the Federal Register on June 11, 2008 (FRL-8368-2), persons
other than the registrant are allowed to continue to sell and distribute
two fenamiphos products, Nemacur 10% Turf and Ornamental Nematicide (EPA
Reg. No. 432-1291) and Nemacur 3 Emulsifiable Systemic
Insecticide-Nematicide (EPA Reg. No. 264-731) until November 30, 2008.

Revised labels for all fenamiphos products were submitted to the Agency
in accordance with the registrant's request for an amendment of all of
its existing registrations.

Use of existing stocks in the channels of trade may continue until
depleted, except where prohibited by the revised labels.

For More Information

Numerous opportunities for public comment were offered as this decision
was being developed. The fenamiphos IRED document was issued in final
(see   HYPERLINK
"http://www.epa.gov/pesticides/reregistration/status.htm"
www.epa.gov/pesticides/reregistration/status.htm ), without a formal
public comment period. However, the docket remains open, and any
comments submitted in the future will be placed in this public docket.

A copy of the Interim RED and all supporting documents are available on
the Agency's website at   HYPERLINK
"http://www.epa.gov/pesticides/reregistration/status.htm"
www.epa.gov/pesticides/reregistration/status.htm .


[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Pages 13357-13358]
[FR Doc No: 2016-05653]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Intent to Prepare Environmental Assessments and Revised
Procedural Schedule

FFP Missouri 16, LLC.........  Project No. 13753-002
FFP Missouri 15, LLC.........  Project No. 13762-002

Solia 8 Hydroelectric, LLC...  Project No. 13771-002
FFP Missouri 13, LLC.........  Project No. 13763-002
Solia 5 Hydroelectric, LLC...  Project No. 13766-002
Solia 4 Hydroelectric, LLC...  Project No. 13767-002
FFP Missouri 12, LLC.........  Project No. 13755-002
FFP Missouri 5, LLC..........  Project No. 13757-002
FFP Missouri 6, LLC..........  Project No. 13761-002
Solia 6 Hydroelectric, LLC...  Project No. 13768-002

    On February 3, 2014, February 27, 2014, and March 14, 2014, FFP New
Hydro, LLC and its subsidiary companies filed a total of ten
applications for the construction and operation of hydropower projects
to be located at the U.S. Army Corps of Engineers' (Corps') existing
dams on the Allegheny River (one project), Monongahela River (six
projects), and Ohio River (three projects), respectively. The names and
locations of the applicants' projects are as follows:

----------------------------------------------------------------------------------------------------------------
                                                                              Capacity (MW)    County, State &
            Applicant                  Project No.            Projects              *            river basin
----------------------------------------------------------------------------------------------------------------
FFP Missouri 16, LLC............  P-13753.............  Opekiska Lock and               6.0  Monongalia, WV;
                                                         Dam.                                 Monongahela.
FFP Missouri 15, LLC............  P-13762.............  Morgantown Lock and             5.0  Monongalia, WV;
                                                         Dam.                                 Monongahela.
Solia 8 Hydroelectric, LLC......  P-13771.............  Point Marion Lock               5.0  Fayette, PA;
                                                         and Dam.                             Monongahela.
FFP Missouri 13, LLC............  P-13763.............  Grays Landing Lock             12.0  Greene, PA;
                                                         and Dam.                             Monongahela.
Solia 5 Hydroelectric, LLC......  P-13766.............  Maxwell Locks and              13.0  Washington, PA;
                                                         Dam.                                 Monongahela.
Solia 4 Hydroelectric, LLC......  P-13767.............  Monongahela Locks              12.0  Washington, PA;
                                                         and Dam 4.                           Monongahela.
FFP Missouri 12, LLC............  P-13755.............  Allegheny Lock and             17.0  Allegheny, PA;
                                                         Dam 2.                               Allegheny.
FFP Missouri 5, LLC.............  P-13757.............  Emsworth Locks and             24.0  Allegheny, PA;
                                                         Dam.                                 Ohio.
FFP Missouri 6, LLC.............  P-13761.............  Emsworth Back                  12.0  Allegheny, PA;
                                                         Channel Dam.                         Ohio.
Solia 6 Hydroelectric, LLC......  P-13768.............  Montgomery Locks               42.0  Beaver, PA; Ohio.
                                                         and Dam.
----------------------------------------------------------------------------------------------------------------
* The combined generator capacity in megawatts.

    On December 17, 2015, the Commission issued a Notice of Application
Ready for Environmental Analysis, and Soliciting Comments,
Recommendations, Preliminary Terms and Conditions, and Preliminary
Fishway Prescriptions (REA Notice) and a Scoping Document 2 for each
river basin, including the Ohio River projects (P-13757, P-13761, P-
13768), the Allegheny River Project (P-13755), and the Monongahela
River projects (P-13753, P-13762, P-13771, P-13763, P-13766, and P-
13767). Each Scoping Document 2 included a procedural schedule that
included preparation of one multi-project Draft and Final Environmental
Assessment (EA) for all ten projects.
    Based on a review of the comments received in response to the REA
notice, Commission staff have determined that the analysis of the
proposed licensing action could be expedited for some of the projects
with the preparation of three separate EAs; one for the three Ohio
River projects, one for the Allegheny River Project, and one for the
six Monongahela River projects. Potential cumulative effects for all
projects will still be evaluated as described in Scoping Document 2. In
addition, whether Final EAs are issued or not will depend on the extent
and scope of the comments received on the EAs. Absent the issuance of
final EAs, comments on the EAs will be addressed in any license order
issued by the Commission.
    The applications will be processed according to the following
revised procedural schedule. Revisions to the schedule may be made as
appropriate.

------------------------------------------------------------------------
                 Milestone                           Target date
------------------------------------------------------------------------
Issue Ohio River projects EA..............  May/June 2016.
Comments on Ohio River projects EA due....  June/July 2016.
Issue Allegheny River project EA..........  May/June 2016.
Comments on Allegheny River project EA due  June/July 2016.
Issue Monongahela River projects EA.......  September 2016.
Comments on Monongahela River projects EA   October 2016.
 due.
------------------------------------------------------------------------

    Any questions regarding this notice may be directed to Nicholas
Ettema at<PHONE_NUMBER>, or by email at<EMAIL_ADDRESS>
    Dated: March 8, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-05653 Filed 3-11-16; 8:45 am]
BILLING CODE 6717-01-P


1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM Subject: Review of Administrative Materials in support of an Application to Amend and Extend the Experimental Use Permit for Genetically Modified Corn ( Vector ZMIR13L) Producing a Cry3Bb1 Protein that Provides Control of Corn Rootworm ( Diabrotica sp.). EPA Reg. No. 524 EUP 93; DP Barcode D290025; Case No. 065182; Submission No. S632862; Chemical No. 6484.

From: Robyn Rose, Entomologist Biopesticides and Pollution Prevention Division, 7511C Peer Review: Zigfridas Vaituzis, Ph. D., Microbiologist Biopesticides and Pollution Prevention Division, 7511C To: Mike Mendelsohn, Regulatory Action Leader Biopesticides and Pollution Prevention Division, 7511C Classification: It is acceptable to plant MON 863 corn.

Background:

Monsanto has requested an amendment and extension to their application for the Experimental Use Permit ( EUP) 524 EUP 93 for corn event MON 863 in a letter dated April 1, 2003 from Dennis Ward ( Monsanto, Regulatory Affairs Manager) to Dennis Szuhay ( EPA/ OPP/ BPPD Microbial Pesticides, Acting Branch Chief). The previous EUP application for MON 863 corn that Monsanto is requesting to amend was submitted on December 11, 2002. Event MON 863 expressed in corn has been granted a Section 3 registration ( 524 LEI) since the previous submission requesting an EUP. Monsanto is requesting this amendment and extension to 524 EUP 93 in order " to continue development work on combined insecticidal trait hybrids created by crossing MON 863 corn line to other lines containing registered plant incorporated protectants."

Monsanto intends to plant a total of 2,304 acres among 33 states plus Puerto Rico and Hawaii during the 2003 growing season ( Table 1). In addition to the acreage planted for the trials 2 described below, 260 acres planted among 7 states is being reserved by Monsanto as " unassigned acreage" ( Table 2). Event MON 863 field corn hybrids expressing the Cry3Bb1 protein will be planted in addition to hybrids containing additional Bt events ( e. g., event MON 810). Cry3Bb1 is a coleopteran active protein that is labeled to control corn rootworm species ( Diabrotica spp.) except for southern corn rootworm. Hybrids will be evaluated for efficacy against corn rootworms as well as lepidopteran insects in the combined trait hybrids. MON 863 research plots will be planted at research stations, seed production fields, privately owned and University farms from May 15, 2003 through June 30, 2004.

A " time limited" exemption from a tolerance for Cry3Bb1 protein and the genetic material necessary for its production in field corn, sweet corn and popcorn is published in the 40 CFR § 180.1214. Toxicity studies submitted to EPA in support of the Cry3Bb1 registration include MRID Nos. 454240 00, 454240 01, 454240 02, 454240 05, 454240 07, 454240 08, 454240 09, 454240 10, 454240 11, 455382 01, 455382 02, 455382 03, 455382 09, 455770 00 and 455770 02. Efficacy studies submitted to EPA include MRID Nos. 451568 00, 453613 03 and 455770 01.

Table 1. Proposed Acreage and Active Ingredient Quantities for Each State and Territory State Acreage Planting Seed ( lbs) Active Ingredient in Planting Seed ( g)

AL 8 128 6 AR 8 128 6 CA 225 3,600 157 CO 74 1,184 52 DE 8 128 6 FL 8 128 6 GA 8 128 6 HI 400 6,400 229 IA 139 2,224 97 ID 8 128 6 IL 139 2,224 97 IN 139 2,224 97 KS 74 1,184 52 KY 8 128 6 LA 8 128 6 MD 8 128 6 State Acreage Planting Seed ( lbs) Active Ingredient in Planting Seed ( g)

3 MI 68 1,088 47 MN 139 2,224 97 MO 68 1,088 47 MS 8 128 6 MT 8 128 6 NC 8 128 6 ND 38 608 26 NE 139 2,224 97 NM 8 128 6 NY 68 1,088 47 OH 74 1,184 52 OK 38 608 26 PA 68 1,088 47 PR 100 1,600 70 SD 74 1,184 52 TN 8 128 6 TX 38 608 26 UT 8 128 6 VA 8 128 6 WI 74 1,184 52 Total 2304 36,864 1,606 Table 2. Acreage to be planted per trial Acreage by State & Protocol Code State 1 2 3 4 5 6 7 8 U** ( Acres) AL 0 0 4 2 0 0 0 2 0 8 AR 0 0 4 2 0 0 0 2 0 8 CA 50 175 0 0 0 0 0 0 0 225 CO 0 0 40 10 0 5 0 19 0 74 DE 2 0 5 1 0 0 0 0 0 8 FL 1 1 4 1 0 0 0 1 0 8 GA 1 1 4 1 0 0 0 1 0 8 HI 60 200 80 0 20 0 0 0 40 400 4 IA 10 10 33 16 10 5 10 5 40 139 ID 1 1 4 1 0 0 0 1 0 8 IL 10 10 33 16 10 5 10 5 40 139 IN 10 15 33 16 10 5 5 5 40 139 KS 0 0 30 10 0 5 10 19 0 74 KY 1 1 4 1 0 0 0 1 0 8 LA 1 1 4 1 0 0 0 1 0 8 MD 1 1 3 1 0 0 1 1 0 8 MI 4 0 36 15 0 0 0 13 0 68 MN 10 20 33 16 10 5 0 5 40 139 MO 4 0 31 15 0 5 0 13 0 68 MS 0 0 4 2 0 0 0 2 0 8 MT 0 0 4 2 0 0 0 2 0 8 NC 1 1 4 1 0 0 0 1 0 8 ND 4 10 10 6 0 0 0 8 0 38 NE 15 20 38 10 6 5 0 5 40 139 NM 0 0 4 2 0 0 0 2 0 8 NY 4 0 31 10 0 0 10 13 0 68 OH 1 4 30 15 0 5 0 19 0 74 OK 0 0 10 15 0 0 0 13 0 38 PA 4 0 36 15 0 0 0 13 0 68 PR 40 20 10 0 10 0 0 0 20 100 SD 1 4 35 15 0 0 0 19 0 74 TN 1 1 4 1 0 0 0 1 0 8 TX 1 2 8 7 0 5 0 15 0 38 UT 0 0 4 2 0 0 0 2 0 8 VA 1 1 4 1 0 0 0 1 0 8 WI 1 4 30 15 0 5 0 19 0 74 TOTA 240 503 651 244 76 55 46 229 260 2,304 * Table provided by Monsanto ** Unassigned acreage at this time, being held in reserve 1 Breeding and Observation Nursery Trials 2 Inbred Seed Increase Production Trials 3 Line Per Se and Hybrid Yield Trials 4 Insect Efficacy Trials 5 Product Characterization, Performance and Labeling Trials 6 Insect Resistant Management Trials 7 Nontarget Organisms and Benefit Trials 8 Seed Treatment Trials EUP Label Statements Proposed by Monsanto:

° " FOR EXPERIMENTAL USE ONLY" ° " Not for sale to any person other than a participant or cooperator of the EPA approved Experimental Use Program." 5 ° " For use only at a site of a participant or cooperator and in accordance with the terms and conditions of the Experimental Use Permit." ° " This package contains corn rootworm protected corn seed producing Cry3Bb1, and insecticidal protein from Bacillus thuringiensis. This protein is effective in controlling corn rootworm ( Diabrotica spp.) larvae." ° " Active Ingredient: Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production ( vector ZMIR13L) in event MON 863 corn..... 0.001 0.006%" ° " Inert Ingredients: Substance produced by marker gene and the genetic material necessary for its production ( ZMIR13L) in corn........... 0.00002  0.00003%." ° " The contents may only be used according to the approved EUP program. Cooperators must have at least one copy of each applicable protocol prior to initiating any research with the contents." ° " Any seed not used in these experiments must be returned to Monsanto Company or seed company partners / affiliates, or disposed of as specified in the field protocols."

Experimental Program Summary:

Sampling Samples including whole corn plants, tissue and/ or seed may be sent to Monsanto or other laboratories for analysis.

Isolation Research plots will not be isolated or contained since it is not required.

Schedule There will be continuos plantings in Hawaii and Puerto Rico and at least two plantings per site in the continental U. S. Plantings in the continental U. S. will occur from February until June and fields will be harvested from August to November.

Final Disposition Seed that is not planted under this EUP may be used for other research purposes, as food or feed, returned to Monsanto or seed companies or destroyed. Corn plants will be destroyed after data collection and harvested corn may be used in additional research, for future plantings or as food or feed.

1) Breeding and Observation Nursery Trials According to Monsanto, these trials will be conducted to "[ o] bserve the phenotype of corn expressing the cry3Bb1 gene in different elite corn lines derived from event MON 863 ( vector ZMIR13L) and/ or maintain these transgenic lines through seed production." Corn plants containing event MON 863 in various genetic backgrounds will be used in these trials. Hybrids containing MON 863 and MON 810 will be planted ( per personal communication between Russ Schneider and Mike Mendelsohn, 6 19 03). A total of 240 acres will be planted among 27 states for these trials ( Table 2). Plants containing the cry3Bb1 gene will be hand pollinated with non Bt 6 corn or other Bt corn hybrids. Hand pollination will be accomplished by selfing, backcrossing or crossing plants to a tester line.

2) Inbred Seed Increase Production Trials According to Monsanto, these trials will be conducted to "[ p] roduce quantities of seed and plant material for further testing and product development." Seed will be generated by allowing inbred corn lines containing the cry3Bb1 gene to open pollinate. Hybrids containing MON 863 and MON 810 will be planted A total of 503 acres will be planted among 22 states for these trials ( Table 2).

3) Line Per Se and Hybrid Yield Trials According to Monsanto, these trials will be conducted to "[ a] ssess any agronomic effects of the genetic insertion in corn event MON 863 ( vector ZMIR13L) in different corn genetic backgrounds." Up to 100 inbred and hybrid corn lines with and without the cry3Bb1 gene will be planted per location in a randomized design or as single large blocks. Hybrids containing MON 863 and MON 810 will be planted Agronomic characteristics ( e. g., early vigor, plant color and height, days to flowering and maturity, yield, test weight) will be evaluated. A total of 651 acres will be planted among 35 states for these trials ( Table 2).

4) Insect Efficacy Trials According to Monsanto, these trials will be conducted to "[ a] ssess the efficacy of corn expressing the cry3Bb1 gene in different corn genetic backgrounds against corn rootworms and other potential soil pests of corn. Efficacy against a number of lepidopteran pests will be evaluated in combined trait hybrids." Inbred and hybrid corn lines with and without the cry3Bb1 gene will be planted per location in a randomized design or as single large blocks. Hybrids containing MON 863 and MON 810 will be planted. Untreated and insecticide treated plots will serve as controls. Yield and efficacy against insect pests particularly the corn rootworm will be evaluated. A total of 244 acres will be planted among 33 states for these trials ( Table 2).

5) Product Characterization, Performance and Labeling Trials According to Monsanto, these trials will be conducted "[ t] o produce grain and plant material for product characterization, further regulatory testing, benefit studies, and product labeling purposes." Seed will be generated by hand pollinating or allowing corn lines containing the cry3Bb1 gene to open pollinate. Plots may also be sampled for analyses of composition, equivalency phenotype and molecular characterization in the laboratory. Hybrids containing MON 863 and MON 810 will be planted. Untreated and insecticide treated plots will serve as controls. A total of 76 acres will be planted among 7 states for these trials ( Table 2).

6) Insect Resistant Management Trials According to Monsanto, these trials will be conducted "[ t] o develop addition data for use in further refining a corn rootworm insect resistance management ( IRM) plan. Studies include characterizing dose, larval movement, adult movement and mating behavior, and effects of Cry3Bb1 protein on adult fitness." Inbred and hybrid corn lines with and without the cry3Bb1 7 gene will be planted per location in a randomized design or as single large blocks. Hybrids containing MON 863 and MON 810 will be planted. Untreated and insecticide treated plots will serve as controls. These trials will include studies on larval movement within and between rows, seed mixes, efficacy, adult emergence and yield. Emerged adults will also be evaluated for fitness and in conjunction with efficacy trials. A total of 55 acres will be planted among 10 states for these trials ( Table 2).

7) Nontarget Organisms and Benefit Trials According to Monsanto, these trials will be conducted to "[ d] evelop additional data to assess the impact of Cry3Bb1 protein on nontarget organisms, including a wide variety of soil and surfacedwelling organisms. The potential for interactive effects of multiple Bt proteins on nontarget organisms will be evaluated in the combined trait hybrids." Inbred and hybrid corn lines with and without the cry3Bb1 gene will be planted per location in a randomized design or as single large blocks. Hybrids containing MON 863 and MON 810 will be planted. Untreated and insecticide treated plots will serve as controls. These trials will be conducted to assess microbial community structure, earthworm populations, and terrestrial invertebrates at the soil surface and below. These trials will also evaluate potential synergistic effects in the Cry3Bb1/ Cry1 stacked products. A total of 46 acres will be planted among 6 states for these trials ( Table 2).

8) Seed Treatment Trials According to Monsanto, these trials will be conducted "[ t] o evaluate effects of diverse seed treatments, in combination with transgenic corn, on corn rootworm and additional insect pests." Transgenic and nontransgenic corn lines with and without the cry3Bb1 gene will be planted per location in a randomized design or as single large blocks. Hybrids containing MON 863 and MON 810 will be planted. Corn seed will be treated with a variety of insecticides. Untreated and insecticide treated plots will serve as controls. Effects on agronomic characteristics ( e. g., germination, seedling vigor) and efficacy against corn rootworms and other insect pests will be evaluated. A total of 229 acres will be planted among 32 states for these trials ( Table 2).

ENVIRONMENTAL EFFECTS A. Non target species effects 1. Hazard Assessment for Terrestrial Animals a. Avian: Data already on file at EPA for Bt crystal proteins and published data show that consumption of Bacillus thuringiensis crystal protein containing corn has no measurable deleterious effects on avian species. This indicates that the proposed limited time/ acreage EUP is not likely to have any measurable effects on avian wildlife.

b. Mammalian Wildlife: Many different Bacillus thuringiensis crystal proteins have been 8 evaluated in mammalian toxicology tests in the last 40 years. In addition, eighty percent of Bt corn produced in the last 5 years has been fed to poultry and livestock. No adverse effects have been observed in mammals upon oral exposure to any of the Bt crystal proteins. The mammalian toxicology data already on file at EPA for Bt crystal proteins and published data also indicate that there is no significant toxicity to rodents from acute oral testing at the maximum hazard dose levels. In light of the above toxicology information, risk to mammalian wildlife from the proposed limited time/ acreage EUPs is expected to be minimal to nonexistent.

c. Non target Plants: Since the active ingredient in this product is an insect toxin that has never shown any toxicity to plants, these studies have been waived for this product. The pollen outcrossing issues are addressed below.

d. Non target invertebrates:

1. Honey Bees: Data on file at EPA for Bt crystal proteins show that the consumption of Bt protein containing corn pollen has no measurable deleterious effects on adult honey bees and larvae. In addition, since corn is wind pollinated, few honey bees are expected to be exposed. As a result, no discernible detrimental effects to honey bees are expected from the proposed limited time/ acreage EUPs .

2. Lady beetle predator: Data on file at EPA for Bt crystal proteins, including Cry3Bb1, show that no adverse effects to Hippodamia convergens, an indicator species for predatory beetles, are expected. Lady beetles may feed on prey or pollen in the EUP fields, however, no detectable effects of reduction in the abundance of beetles is expected from the limited duration and acreage of the proposed EUP 3. Earthworm and Collembola: Published data, and data on file at EPA for Bt crystal proteins show that the consumption of Bacillus thuringiensis crystal protein has no measurable deleterious effects on earthworms or collembola ( Folsomia candida), representative beneficial soil invertebrate species. The proposed limited time/ acreage EUP is not likely to have any measurable effects on beneficial soil invertebrates.

4. Non target insects: Published data, and data on file at EPA show that exposure to Bt proteins from corn plants in the field has no measurable detrimental effect on non target insects. Therefore, the proposed limited time/ acreage EUP is not likely to have any measurable effects on non target insects. As part of the EUP program, trials will be conducted to assess microbial community structure, earthworm populations, and terrestrial invertebrates at the soil surface and below.

2. Hazard Assessment for Aquatic Animals a. Fish: The requirement for a static renewal toxicity study is normally waived based on a lack of exposure of fish to the Bt protein produced in corn. Exposure from corn pollen, if it does take 9 place, will be of a very short duration and quantity and is not expected to have any detectable effect on freshwater fish.

b. Aquatic Invertebrates: Published and in house data for Bt crystal protein containing corn show that Bt crystal proteins have no measurable deleterious effects on Daphnia magna, a sensitive aquatic invertebrate species. The data indicate that the expected environmental concentration of corn pollen from the proposed limited time/ acreage EUP is not likely to have any measurable effects on aquatic invertebrates.

c. Estuarine and Marine Animals: The estuarine fish and shrimp studies are not required for this product because of very low potential for exposure.

Non target Effects Summary: Published and in house data for Bt crystal protein containing corn show that the Cry proteins are very species specific in their activity, therefore no measurable or irreversible interactions with non target organisms are anticipated for the proposed limited duration and limited acreage EUP. The nature of the EUP programs and the expression of the active ingredient within the corn plant limits exposure to non target species.

B. Outcrossing and Weediness There is no evidence of transfer of any gene, including introduced genes, to organisms other than those with which corn is sexually compatible. In addition, there are no weedy relatives of corn in the areas near the trial sites.

C. Environmental fate Numerous studies, when performed under realistic conditions, have shown that the Bt proteins produced in Bt crops are rapidly degraded in the soil. This was confirmed in a FIFRA Scientific Advisory Panel Report ( December 8, 1999). The Panel concluded that " bioaccumulation is not expected to occur with transgenic proteins because biodegredation mechanisms for proteins are ubiquitous." The degradation of Bt protein in plant tissue has been evaluated for several Bt crops that has been approved by EPA as part of regulatory requirements. In addition, EPA scientists have carried out independent studies which have evaluated the degradation of Bt proteins in Bt cotton ( Cry1Ac and Cry1Ab) and Btt potato ( Cry3A) in soil. All of these studies have demonstrated that the Bt proteins expressed in Bt plants are degraded at rates similar to microbial Bt products. Thus all evidence to date shows that, when degradation of Bt proteins in soil are assessed under realistic conditions, the proteins in Bt plants readily degrade, as expected for proteins.

D. Insect Resistance Management There is not a concern of widespread corn rootworm resistance occurring from the limited acreage that will be planted under this EUP program. 10 E. Endangered species considerations Based on the previously submitted Cry protein toxicity and exposure data there will not be a " may effect" situation for endangered mammals, birds, plants and aquatic species. In addition, because there are no sexually compatible wild or weedy relatives of corn ( Z. mays) in the United States, the Cry protein genes cannot escape into plants on which endangered/ threatened species feed on in these areas. However, all endangered/ threatened insect species ( notably Coleoptera) that may be susceptible to the Bacillus thuringiensis crystal proteins may be adversely affected if exposed. Therefore, the test plots for the proposed EUP program must not be near the habitats of endangered beetle { Coleoptera) species since it has not been determined that these will not be adversely affected if exposed to the Bt protein in the soil or through pollen consumption. However, exposure of endangered beetles to toxic levels of Cry proteins in the field from this EUP appears to be highly unlikely. Nevertheless, the EUP test plots must not be located near the habitats of endangered coleopteran species in the following counties:

American burying beetle ( Nicrophorus americanus) in Kansas ( Doniphan, Douglas, Montgomery, Pottawatomie, Riley, and Saline Counties), in Missouri ( Bollinger, Boone, Franklin, Howard, Jefferson, Mississippi, Newton, St. Louis, and Wayne counties). and in South Dakota ( Brookings, Haakon and Union counties). Nebraska ( North Platte and Lincoln, Dawson and Cherry counties).

Hungerford's crawling water beetle ( Brychius hungerfordi) only along the East Branch of the Maple River, Emmet County, Michigan; the East Branch of the Black River, Montmorency County, Michigan;

HAZARD ASSESSMENT Adverse effects to populations of nontarget organisms from planting MON 863 corn are not expected from this limited acreage EUP. Based on published information and previously submitted studies for registered Bt Cry proteins, including Cry3Bb1, no detectable or irreversible hazard to terrestrial or aquatic nontarget species is anticipated from this short duration small acreage EUP. Detectable amounts of Cry protein are not expected to accumulate and persist in soil in these experimental plots.

BPPD Conclusions: No significant or irreversible hazards to non target organisms are anticipated for the short duration of this limited acreage experimental use providing that testing does not take place in the vicinity of endangered beetle habitats. Based on the previously submitted Cry protein toxicity and exposure data there will not be a " may effect" situation for endangered mammals, birds, plants and aquatic species. All endangered/ threatened insect species that are susceptible to Cry3Bb1 ( e. g., coleopterans) may be adversely affected if exposed. In the case of Cry3Bb1 protein, the test plots for the proposed EUP program must not be near the habitats of endangered beetle ( coleopteran) species since these may be adversely affected if exposed to the Bt protein in the soil or through pollen consumption. 11


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

                    Issued by the Department of Transportation on
November 21, 2000

NOTICE OF ACTION TAKEN -- DOCKET OST-2000-8211

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no

additional confirming order will be issued in this matter).

Applicant:  BWIA International Airways Limited					Date Filed:  October
30, 2000

Relief requested:  Exemption from 49 U.S.C. 41301 to conduct scheduled
foreign air transportation of persons, property and mail between
Trinidad and Tobago and Atlanta, GA, via the intermediate point
Barbados.

If renewal, date and citation of last action:  New authority

Applicant representative:  William Evans<PHONE_NUMBER>

Responsive pleadings:  None

	DISPOSITION

Action:  Approved									Action date:  November 21, 2000

Effective dates of authority granted:  November 21, 2000  -  November
21, 2001

Basis for approval (bilateral agreement/reciprocity):  Reciprocity

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

 X Standard exemption conditions (attached)        __ Foreign air
carrier permit conditions (Order   -  -  )

Special conditions/Partial grant/Denial basis/Remarks:

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
____________________________________________________________

We found that the applicant was qualified to perform its proposed
operations.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within ten (10) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

												        Appendix A

FOREIGN AIR CARRIER CONDITIONS OF AUTHORITY

In the conduct of the operations authorized, the holder shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are:

   (a)  based on its operations in international air transportation
that, according to the contract of carriage, include a point in the
United States as a point of origin, point of destination, or agreed
stopping place, or for which the contract of carriage was purchased in
the United States; or

   (b)  based on a claim under any international agreement or treaty
cognizable in any court or other tribunal of the United States.

In this condition, the term "international air transportation" means
"international transportation" as defined by the Warsaw Convention,
except that all States shall be considered to be High Contracting
Parties for the purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, comply (except as otherwise
provided in the applicable bilateral agreement) with the Department's
rules governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code (formerly the
Federal Aviation Act of 1958, as amended).

(41301/40109) 9/98


[Federal Register Volume 88, Number 66 (Thursday, April 6, 2023)]
[Notices]
[Pages 20509-20511]
[FR Doc No: 2023-07220]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas & Oil Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: PR23-40-000.
    Applicants: Regency Intrastate Gas LP.
    Description: Sec.  284.123 Rate Filing: Regency Intrastate Gas LP
Operating Statement 4-1-2023 to be effective 4/1/2023.
    Filed Date: 3/30/23.
    Accession Number: 20230330-5177.
    Comment Date: 5 p.m. ET 4/20/23.

    Docket Numbers: PR23-41-000.
    Applicants: Columbia Gas of Ohio, Inc.
    Description: Sec.  284.123 Rate Filing: COH Rates effective March 1
2023 to be effective 3/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5255.
    Comment Date: 5 p.m. ET 4/21/23.

    Docket Numbers: RP23-619-000.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Volume No. 2--XTO Energy Inc.
& GDF Suez to be effective 4/1/2023.
    Filed Date: 3/30/23.
    Accession Number: 20230330-5154.
    Comment Date: 5 p.m. ET 4/11/23.

    Docket Numbers: RP23-620-000.
    Applicants: Elba Express Company, L.L.C.
    Description: Compliance filing: Annual Interruptible Revenue
Crediting Report 2023 to be effective N/A.
    Filed Date: 3/30/23.
    Accession Number: 20230330-5173.
    Comment Date: 5 p.m. ET 4/11/23.

    Docket Numbers: RP23-621-000.
    Applicants: Northern Border Pipeline Company.
    Description: Sec.  4(d) Rate Filing: Compressor Usage Surcharge
2023 to be effective 5/1/2023.
    Filed Date: 3/30/23.
    Accession Number: 20230330-5176.
    Comment Date: 5 p.m. ET 4/11/23.

    Docket Numbers: RP23-622-000.
    Applicants: Kern River Gas Transmission Company.
    Description: Kern River Gas Transmission Company submits Annual Gas
Compressor Fuel Report for 2022.
    Filed Date: 3/30/23.
    Accession Number: 20230330-5215.
    Comment Date: 5 p.m. ET 4/11/23.

    Docket Numbers: RP23-624-000.
    Applicants: East Tennessee Natural Gas, LLC.
    Description: Sec.  4(d) Rate Filing: 2023 ETNG Fuel Filing to be
effective 5/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5020.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-625-000.
    Applicants: East Tennessee Natural Gas, LLC.
    Description: Compliance filing: 2021-2022 ETNG Cashout Report to be
effective N/A.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5021.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-626-000.
    Applicants: Eastern Gas Transmission and Storage, Inc.
    Description: Sec.  4(d) Rate Filing: EGTS--March 31, 2023 MCS
Negotiated Rate Agreements to be effective 4/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5025.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-627-000.
    Applicants: Eastern Gas Transmission and Storage, Inc.
    Description: Sec.  4(d) Rate Filing: EGTS--Interim Fuel Retention
Percentages to be effective 5/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5030.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-628-000.
    Applicants: Alliance Pipeline L.P.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Various Apr
1 2023 Releases to be effective 4/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5031.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-629-000.
    Applicants: MountainWest Pipeline, LLC.
    Description: Sec.  4(d) Rate Filing: Contact Information Update for
2023 to be effective 5/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5034.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-630-000.
    Applicants: MountainWest Overthrust Pipeline, LLC.
    Description: Sec.  4(d) Rate Filing: Contact Information Update for
2023 to be effective 5/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5035.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-631-000.
    Applicants: White River Hub, LLC.
    Description: Sec.  4(d) Rate Filing: Contact Information Update for
2023 to be effective 5/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5036.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-632-000.
    Applicants: Pine Needle LNG Company, LLC.
    Description: Sec.  4(d) Rate Filing: 2023 Annual Fuel and Electric
Power Tracker Filing to be effective 5/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5040.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-633-000.
    Applicants: Panhandle Eastern Pipe Line Company, LP.

    Description: Compliance filing: Flow Through of Penalty Revenues
Report filed 3-31-23 to be effective N/A.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5041.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-634-000.
    Applicants: Panhandle Eastern Pipe Line Company, LP.
    Description: Compliance filing: Flow Through of Cash-Out Revenues
filed on 3-31-23 to be effective N/A.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5043.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-635-000.
    Applicants: Enable Gas Transmission, LLC.
    Description: Compliance filing: 2023 Annual IT Revenue Crediting
Filing to be effective N/A.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5046.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-636-000.
    Applicants: Enable Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Fuel Tracker Filing--Effective
May 1, 2023 to be effective 5/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5047.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-637-000.
    Applicants: Gulf South Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmts (FPL
48381, 41618, 41619 to various eff 4-1-2023) to be effective 4/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5048.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-638-000.
    Applicants: Enable Mississippi River Transmission, LLC.
    Description: Compliance filing: 2023 Annual SCT Revenue Crediting
Filing to be effective N/A.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5049.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-639-000.
    Applicants: Gulf South Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Non-conforming Agreements
Filing (NNS-SCO) to be effective 4/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5050.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-640-000.
    Applicants: Gulf South Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmts (JERA
46434, 46435 to EDF 56120, 56117) to be effective 4/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5051.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-641-000.
    Applicants: Gulf South Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmts (BP
51411 to BP 56164, 56165) to be effective 4/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5054.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-642-000.
    Applicants: Gulf South Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmt (BP
55005 to BP 56137) to be effective 4/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5055.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-643-000.
    Applicants: Gulf South Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Fuel Neg Rate Agmt (PowerSouth
54058) to be effective 4/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5056.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-644-000.
    Applicants: Gulf South Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmts (WSGP
to Tenaska eff 4-1-23) to be effective 4/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5057.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-645-000.
    Applicants: MarkWest New Mexico, L.L.C.
    Description: Sec.  4(d) Rate Filing: Housekeeping Filing to be
effective 5/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5058.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-646-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: TCO Negotiated Rate Agreements
Eff. 4.1.23 to be effective 4/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5074.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-647-000.
    Applicants: Destin Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Destin Pipeline Negotiated
Rate Agreement Filing to be effective 4/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5105.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-648-000.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Volume No. 2--Mex Gas and
Morgan Stanley to be effective 4/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5173.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-649-000.
    Applicants: Great Lakes Gas Transmission Limited Partnership.
    Description: Sec.  4(d) Rate Filing: GLGT April 1 Negotiated Rate
Agreements to be effective 3/31/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5204.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-650-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Cherokee
AGL--Replacement Shippers--Apr 2023 to be effective 4/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5213.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-651-000.
    Applicants: LA Storage, LLC.
    Description: Sec.  4(d) Rate Filing: Filing of Negotiated Rate
Conforming IW Agreement 3.31.23 to be effective 4/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5221.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-652-000.
    Applicants: Kinder Morgan Louisiana Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Out-of-Cycle Fuel Adjustment
Effective May 1, 2023 to be effective 5/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5224.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-653-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: REX 2023-03-31 Negotiated Rate
Agreement and Amendments to be effective 4/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5239.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-654-000.
    Applicants: Ruby Pipeline, L.L.C.
    Description: Sec.  4(d) Rate Filing: RP 2023-03-31 Negotiated Rate
Agreements to be effective 5/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5245.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-655-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Sec.  4(d) Rate Filing: TPC 2023-03-31 Fuel and L&U

Reimbursement and Power Cost Tracker to be effective 5/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5249.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-656-000.
    Applicants: ANR Pipeline Company.
    Description: Sec.  4(d) Rate Filing: ANR--Vitol 138868 Negotiated
Rate Agreement to be effective 4/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5259.
    Comment Date: 5 p.m. ET 4/12/23.

    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.

Filings in Existing Proceedings

    Docket Numbers: RP23-584-001.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Compliance filing: TPC Annual Incidental Purchases and
Sales Report Amendment to be effective N/A.
    Filed Date: 3/30/23.
    Accession Number: 20230330-5156.
    Comment Date: 5 p.m. ET 4/11/23.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    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: March 31, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-07220 Filed 4-5-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 11 (Thursday, January 16, 2014)]
[Notices]
[Pages 2825-2826]
[FR Doc No: 2014-00726]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2008-0719, FRL 9904-77-OEI]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Cooling Water Intake Structure
Phase II Existing Facilities (Renewal), Cooling Water Intake Structures
at Phase III Facilities (Renewal), and NPDES Animal Sectors (Renewal)

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that three Information
Collection Requests (ICRs) have been forwarded to the Office of
Management and Budget (OMB) for review and approval. This is a request
to renew three existing approved collections, which are currently
approved through January 31, 2014. Public comments were previously
requested via the Federal Register (78 FR 57150) on September 17, 2013
during a 60-day comment period. This notice allows for an additional 30
days for public comments. A fuller description of the ICRs are given
below, including their estimated burden and cost to the public. 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: Additional comments may be submitted on or before February 18,
2014.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2008-0719, to (1) EPA online using www.regulations.gov (our preferred
method), by email to<EMAIL_ADDRESS>or by mail to: Water Docket,
Environmental Protection Agency, Mail Code: 28221T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460 and (2) OMB by email to<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Amelia Letnes, State and Regional
Branch, Water Permits Division, OWM Mail Code: 4203M, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460;
telephone 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<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.

A. List of ICRs Submitted

    (1) Cooling Water Intake Structure Phase II Existing Facilities
(Renewal), EPA ICR No. 2060.06, OMB Control No. 2040-0257; expiration
date 01/31/2014.
    (2) Cooling Water Intake Structures at Phase III Facilities
(Renewal), EPA ICR No. 2169.05, OMB Control No. 2040-0268, expiration
date 01/31/2014.
    (3) NPDES Animal Sectors (Renewal); EPA ICR No. 1989.09; OMB
Control No. 2040-0250, expiration date 01/31/2014.

B. Individual ICRS:

    (1) Cooling Water Intake Structure Phase II Existing Facilities
(Renewal)
    EPA ICR Number: 2060.06
    OMB Control Number: 2040-0257
    Abstract: The section 316(b) Phase II Existing Facility rule
requires the collection of information from existing point source
facilities that generate and transmit electric power (as a primary
activity) or generate electric power but sell it to another entity for
transmission, use a cooling water intake structure (CWIS) that uses at
least 25 percent of the water it withdraws from waters of the U.S. for
cooling purposes, and have a design intake flow of 50 million gallons
per day (MGD) or more. Section 316(b) of the Clean Water Act (CWA)
requires that any standard established under section 301 or 306 of the
CWA and applicable to a point source must require that the location,
design, construction and capacity of CWISs at that facility reflect the
best technology available (BTA) for minimizing adverse environmental
impact. Such impact occurs as a result of impingement (where fish and
other aquatic life are trapped on technologies at the entrance to CWIS)
and entrainment (where aquatic organisms, eggs, and larvae are taken
into the cooling system, passed through the heat exchanger, and then
pumped back out with the discharge

from the facility). The 316(b) Phase II rule establishes requirements
applicable to the location, design, construction, and capacity of CWISs
at Phase II existing facilities. These requirements establish the BTA
for minimizing adverse environmental impact associated with the use of
CWISs.
    Respondents/affected entities: Entities potentially affected by
this action include existing electric power generating facilities
meeting the applicability criteria of the 316(b) Phase II Existing
Facility rule at 40 CFR 125.91.
    Respondent's obligation to respond: Mandatory.
    Estimated number of respondents: 514 (472 facilities and 42
States).
    Frequency of response: Every five years, bi-annually, monthly.
    Total estimated burden: 1,010,021 (965,509 for facilities and
44,513 for States). Burden is defined at 5 CFR 1320.03(b).
    Total estimated cost: $59,478,339. This includes an estimated
burden cost of $48,890,325 and an estimated cost of $10,588,074 for
capital investment or maintenance and operational costs.
    Changes in the Estimates: There is a decrease of 13,500 (1%) hours
in the total estimated respondent burden compared with that identified
in the ICR currently approved by OMB. This marginal change is due to
the variations of the compliance schedule from year to year.
(2) Cooling Water Intake Structures at Phase III Facilities (Renewal)
    EPA ICR Number: 2169.05.
    OMB Control Number: 2040-0268.
    Abstract: The Section 316(b) regulations for Phase III facilities
(71 FR 35,006; June 16, 2006) require the collection of information
from new offshore oil and gas extraction facilities which use a cooling
water intake structure(s) that uses at least 25 percent of the water it
withdraws for cooling purposes, and has a design intake flow greater
than two (2) million gallons per day (MGD). Section 316(b) of the CWA
requires that any standard established under section 301 or 306 of the
CWA and applicable to a point source must require that the location,
design, construction and capacity of cooling water intake structure(s)
at that facility reflect the best technology available for minimizing
adverse environmental impact. Such impact occurs as a result of
impingement (where fish and other aquatic life are trapped on
structural components at the entrance to cooling water intake
structures) and entrainment (where aquatic organisms, eggs, and larvae
are taken into the cooling system, passed through the heat exchanger,
and then pumped back out with the discharge from the facility). The
rule contains requirements applicable to the location, design,
construction, and capacity of cooling water intake structures at new
offshore oil and gas extraction facilities. These requirements seek to
establish the best technology available for minimizing adverse
environmental impact associated with the use of cooling water intake
structure(s).
    Respondents/affected entities: Entities potentially affected by
this action include new offshore oil and gas extraction facilities
meeting the applicability criteria of the 316(b) Phase III Facilities
at 40 CFR 125.131.
    Respondent's obligation to respond: Mandatory.
    Estimated number of respondents: 61 facilities.
    Frequency of response: Every five years, annual, monthly.
    Total estimated burden: 56,755 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $3,754,793. This includes an estimated labor
burden cost of $2,795,603 and an estimated cost of $959,190 for capital
investment or maintenance and operational costs.
    Changes in the Estimates: There is an increase of 22,675 hours in
burden from the ICR currently approved by OMB. The change in burden is
mainly the result of the increase in the number of facilities
performing recurring activities, as well as facilities shifting from
the initial approval period to the permit implementation and renewal
period of the Section 316(b) Phase III rule.
(3) NPDES Animal Sectors (Renewal)
    EPA ICR Number: 1989.09.
    OMB Control Number: 2040-0250.
    Abstract: This ICR covers the information collection burden imposed
under the NPDES and Effluent Limitations Guidelines (ELG) regulations
for Concentrated Animal Feeding Operations (CAFO) and Concentrated
Aquatic Animal Production (CAAP) facilities.
    On July 30, 2012, EPA published its most recent revisions to the
NPDES CAFO regulations (77 FR 44494). These revisions were necessary as
a result of a court decision in 2011 by the United States Court of
Appeals for the Fifth Circuit in litigation relating to the NPDES CAFO
permitting program (National Pork Producers Council v. EPA, 635 F.3d
738, 756 (5th Cir. 2011)). Although the decision narrowed the scope of
CAFOs that need to seek NPDES permit coverage, the Effluent Limitations
Guidelines for CAFOs and other aspects of the permitting program remain
unchanged. As a consequence, the recordkeeping and reporting
requirements faced by those CAFOs that do seek NPDES permit coverage
were not affected.
    The Effluent Limitations Guidelines and Standards for the
Concentrated Aquatic Animal Production (CAAP) Point Source Category
establish specific reporting requirements for a portion of CAAP
facilities through NPDES permits. The rule covers facilities which are
defined as CAAP facilities (see 40 CFR 122.24 and 40 CFR Part 122) and
produce at least 100,000 pounds of fish per year in flow through,
recirculating and net pen systems. The special reporting and record-
keeping requirements under the rule are the subject of this ICR. CAAP
facility owners or operators are also required to file reports with the
permitting authority when drugs with special approvals are applied to
the production units or a failure in the structural integrity occurs in
the aquatic animal containment system.
    Respondents/affected entities: Entities potentially affected by
this action are concentrated animal feeding operations (CAFOs) as
specified in section 502(14) of the CWA, 33 U.S.C. 1362(14) and defined
in the NPDES regulations at 40 CFR 122.23 and a subset of facilities
engaged in aquatic animal production defined in 40 CFR part 451.
    Respondent's obligation to respond: Mandatory.
    Estimated number of respondents: 20,961 (20,915 facilities and 46
States).
    Frequency of response: varies from once to ongoing.
    Total estimated burden: 3,136,799 hours (per year). Burden is
defined at 5 CFR 1320.03(b).
    Estimated total annual costs: $70,924,281. This includes an
estimated cost of $8,607,000 for capital investment or maintenance and
operational costs.
    Changes in the estimates: This updated ICR estimates a total burden
that is 136,879 hours less (4.2%) than the currently approved amount.
This is due primarily to the court decision mentioned previously, which
reduced the number of CAFOs that need to seek NPDES permit coverage.

John Moses,
Director, Collection Strategies Division.
[FR Doc. 2014-00726 Filed 1-15-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 59 (Monday, March 28, 2016)]
[Notices]
[Page 17169]
[FR Doc No: 2016-06889]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Seventh Annual Predictive Safety Testing Consortium/Food and Drug
Administration Scientific Workshop; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration's (FDA's) Center for Drug
Evaluation and Research (CDER), in cosponsorship with the Critical Path
Institute (C-Path), is announcing a public scientific workshop to
discuss the impact of safety biomarkers on drug development. The
purpose of the workshop is to discuss the following issues: Application
of toxicometrics as a translational safety strategy that integrates
nonclinical and clinical safety approaches; uses of rodent and non-
rodent nonclinical species in biomarker qualification; and assay
validation aspects during biomarker development and qualification.

DATES: The public workshop will be held on April 25, 2016, from 8:30
a.m. to 5 p.m.

ADDRESSES: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (Rm. 1503 A/B), Silver Spring, MD 20993-0002.
    The FDA Conference Center is a federal facility and is located on
the White Oak campus and like all federal facilities employs security
procedures. Entrance for scientific workshop participants (non-FDA
employees) is through Building 1, where routine security check
procedures will be performed. For parking and security information,
please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Jacqueline Brooks-Leighton, Food and
Drug Administration, Center for Drug Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 21, Rm. 4521, Silver Spring, MD 20993, 240-402-
5292, FAX:<PHONE_NUMBER>, email: jacqueline.brooks-
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA and C-Path have expressed a willingness to leverage their
combined strengths to develop and apply predictive safety testing
biomarkers in drug development. This annual public workshop is intended
to bring together leading academic experts, interested pharmaceutical
companies, regulatory agencies, patient advocacy groups, and non-profit
organizations.
    This meeting will offer the opportunity to provide updates on the
progress made in various biomarker development areas by the Predictive
Safety Testing Consortium, and to discuss issues related to the
regulatory aspects of qualification and uptake of biomarkers in drug
development, as well as roadblocks to the sharing of biomarker data by
the scientific community.

II. Attendance, Registration, and Accommodations

    There is no fee to attend the meeting, but attendees must register
in advance. Space is limited, and registration will be on a first-come,
first-served basis. Onsite registration on the day of the workshop is
not guaranteed but may be possible if space is available. For questions
regarding registration, please contact Stephanie Codd Anderson, 520-
647-8376, email<EMAIL_ADDRESS>at the Critical Path Institute.
    Persons interested in attending this meeting in person must
register online by April 11, 2016 at http://www.cvent.com/d/2fqzl2/4W.
    FDA has verified the Web address, but is not responsible for
subsequent changes to the Web site after this document publishes in the
Federal Register. Interested persons without Internet access should
contact Stephanie Codd Anderson at<PHONE_NUMBER> to register.
    The public workshop will also be available to be viewed online via
webcast at https://collaboration.fda.gov/pstc0416/.
    Workshop attendees with special needs due to a disability should
contact Stephanie Codd Anderson,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>at the Critical Path Institute at least 7 days
before the scientific workshop.
    Attendees are responsible for their own hotel accommodations.
    There will not be a transcript for this meeting.

    Dated: March 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06889 Filed 3-25-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 242 (Tuesday, December 19, 2023)]
[Notices]
[Page 87829]
[FR Doc No: 2023-27785]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-99161; File No. SR-NYSE-2023-36]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Designation of a Longer Period for Commission Action on
Proceedings To Determine Whether To Approve or Disapprove a Proposed
Rule Change Regarding Enhancements to Its DMM Program

December 13, 2023.
    On October 23, 2023, New York Stock Exchange LLC (``NYSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to make enhancements to its Designated Market
Maker (``DMM'') program. The proposed rule change was published for
comment in the Federal Register on November 13, 2023.\3\ The Commission
has received no comment letters on the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 98869 (November 6,
2023), 88 FR 77625 (November 13, 2023) (SR-NYSE-2023-36).
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding, or as to which the self-regulatory organization
consents, the Commission will either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is December 28, 2023. The Commission is extending this 45-day time
period.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to issue an order approving or disapproving the proposed
rule change, so that it has sufficient time to consider the proposed
rule change. Accordingly, the Commission, pursuant to section 19(b)(2)
of the Act,\5\ designates February 9, 2023, as the date by which the
Commission shall either approve or disapprove the proposed rule change
(File No. SR-NYSE-2023-36).
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-27785 Filed 12-18-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: October 1, 2009 (Volume 74, Number 189)]
[Notices]
[Page 50801]
[DOCID:fr01oc09-84]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2009-E-0017 and FDA-2009-E-0019]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for CLEVIPREX and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human drug product.

ADDRESSES: Submit written comments and petitions to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product
CLEVIPREX (clevidipine butyrate). CLEVIPREX is indicated for the
reduction of blood pressure when oral therapy is not feasible or not
desirable. Subsequent to this approval, the Patent and Trademark Office
received patent term restoration applications for CLEVIPREX (U.S.
Patent Nos. 5,739,152 and 5,856,346) from AstraZeneca AB, and the
Patent and Trademark Office requested FDA's assistance in determining
the patents' eligibilities for patent term restoration. In a letter
dated February 18, 2009, FDA advised the Patent and Trademark Office
that this human drug product had undergone a regulatory review period
and that the approval of CLEVIPREX represented the first permitted
commercial marketing or use of the product. Thereafter, the Patent and
Trademark Office requested that FDA determine the product's regulatory
review period.
    FDA has determined that the applicable regulatory review period for
CLEVIPREX is 4,475 days. Of this time, 4,078 days occurred during the
testing phase of the regulatory review period, while 397 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and CosmeticAct (the act) (21 U.S.C. 355(i)) became effective:
May 3, 1996. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on May 3,
1996.
    2.  The date the application was initially submitted with respect
to the human drug product under section 505(b) of the act: July 2,
2007. FDA has verified the applicant's claim that the new drug
application (NDA) 22-156 was submitted on July 2, 2007.
    3. The date the application was approved: August 1, 2008. FDA has
verified the applicant's claim that NDA 22-156 was approved on August
1, 2008.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 1,314 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by November 30, 2009. Furthermore, any interested person may petition
FDA for a determination regarding whether the applicant for extension
acted with due diligence during the regulatory review period by March
30, 2010. To meet its burden, the petition must contain sufficient
facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format
specified in 21 CFR 10.30.
    Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Comments and petitions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 23, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-23650 Filed 9-30-09; 8:45 am]

BILLING CODE 4160-01-S


                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                  REGION IX
                             75 Hawthorne Street
                           San Francisco, CA  94105

Memorandum

To: 		Nogales, Arizona PM-10 SIP Final Action Approval Docket, Docket ID EPA-R09-OAR-2012-0458

From: 		Jerry Wamsley, Air Planning Office, EPA Region 9

Date: 		August 24, 2012

RE: 		Adequacy documentation for Nogales PM-10 MVEBs in August 2012 ADEQ Nogales PM-10 179B State Implementation Plan

Attached to this memorandum is the adequacy documentation for the Nogales PM-10 MVEB in the August 2012 ADEQ Nogales PM-10 179B Attainment Plan.

In June 2012, Wienke Tax provided an adequacy review of the May 2012 proposed Nogales PM-10 State Implementation Plan.  Portions of that information are incorporated here for reference and continuity.

Table 1. Evaluation of the Motor Vehicle Emissions Budget in the 2012 Nogales SIP
                    August 2012 (reviewed by Jerry Wamsley)
                           Adequacy Review Criteria
                               (40 CFR part 93)
                                 Is Criterion
                                  Satisfied?
                      Reference in SIP Document/Comments

Sec. 93.118(e)(4)(i)
The plan was endorsed by the Governor (or designee) and was subject to a public hearing.
                                       Y
ADEQ has satisfied applicable statutory and regulatory requirements for reasonable public notice and hearing prior to adoption and submittal of the  State Implementation Plan - Nogales PM10 Nonattainment Area, May 2012 ("2012 Nogales Attainment Plan"). The State provided a 30-day public comment period, and held a public hearing prior to the adoption of the Plan on June 21, 2012. Documentation accompanying the SIP describes a public and agency outreach effort. See, e.g., http://www.azdeq.gov/environ/air/plan/notmeet.html#nog and http://www.azdeq.gov/download/calendar/051612pn1.pdf.

As result of comments received on the May 2012, 2012 Nogales Attainment Plan , ADEQ revised the MVEB in the 2012 Nogales Attainment Plan and provided a second 30 day comment period, starting July 24, 2012.  Consistent with state and federal statute, ADEQ offered to hold a public hearing if one was requested by the August 15, 2012.  ADEQ did not receive a request for a public hearing, so no hearing was held.

Both of the SIP submittal included proof of publication for notices of the ADEQ public hearing.  Evidence was provided that the hearings were properly noticed.  See the plan appendices within each submittal.  See appendix K of the submitted plan.
Sec. 93.118(e)(4)(ii)
The plan was developed through consultation with federal, state and local agencies; full implementation plan documentation was provided and EPA's stated concerns, if any, were addressed.
                                       Y
Consultation with federal, state and local agencies was undertaken; this consultation included EPA, ADEQ, and ADOT in March and April of 2012. EPA received several draft versions of the 2012 Nogales Attainment Plan and provided comments.

As part of EPA's review of the May 2012 draft plan, we recommended that road construction dust be included within the MVEB.  See 77 FR 38418-38419; ( June 27, 2012); and, our  letter from Lisa Hanf, EPA to Eric Massey, ADEQ, dated June 21, 2012.

In response, ADEQ revised the MVEB to incorporate road construction dust, vehicle brake wear, and vehicle tire wear emissions.  These changes to the MVEB were the subject of the 30-day public comment period beginning July 24, 2012.  ADEQ consulted with EPA and ADOT as part of revising this MVEB.

EPA concerns were addressed in the final SIP that was adopted and submitted.
Sec. 93.118(e)(4)(iii)
The motor vehicle emission budgets are clearly identified and precisely quantified.
                                       Y
The motor vehicle emissions budget for 2011 is clearly identified and precisely quantified on page 48 of the 2012 Nogales Attainment Plan; see Table 7-1.  This budget reflects federal motor vehicle control measures that were already implemented at the time the ADEQ adopted the 2012 Nogales SIP on August 24, 2012 and was developed using EPA's MOVES model.
Sec. 93.118(e)(4)(iv)
The motor vehicle emissions budget(s), when considered together with all other emission sources, is consistent with applicable requirements for reasonable further progress and attainment.
                                       Y
EPA has concluded that the budget for the year 2011 when considered together with all other emission sources is consistent with the requirement to demonstrate reasonable further progress for the 1987 24-hour PM10 standard. This finding is based on a review of the RFP demonstration in the 2012 Nogales Attainment Plan. As documented in the notice of proposed rule-making, EPA is proposed to approve the RFP demonstration; see 77 FR 38400, (June 27, 2012).
EPA has concluded that the budget for the year 2011 when considered together with all other emission sources is consistent with the requirement to demonstrate attainment of the 1987 24-hour PM10 standard. This finding is based on review of Arizona's CAA Section 179B attainment demonstration in the 2012 Nogales Attainment Plan. As documented in the Federal Register notice, EPA  proposed to approve Arizona's CAA section 179B attainment demonstration; see 77 FR 38400, (June 27, 2012).
The motor vehicle emissions budget for PM10 include emissions from re-entrained road dust (paved and unpaved), road construction dust, and vehicle brake wear, tire wear, and exhaust emissions.  See 2012 Nogales SIP, pages 47-48, and Table 7-1.
Sec. 93.118(e)(4)(v)
The plan shows a clear relationship among the emissions budget(s), control measures and the total emissions inventory.
                                       Y
The emission inventories for all point, area, and mobile sources within the Nogales nonattainment area are contained in Chapter 3, pages 13-15, and Appendix B of ADEQ's 2012 Nogales Attainment Plan. The relationship of the emission inventory to control measures and the reductions from the measures are described in Chapter 5  -  Control Measures of the 2012 Nogales Attainment Plan.
Sec. 93.118(e)(4)(vi)
Revisions to previously submitted control strategy or maintenance plans explain and document any changes to any previous submitted budgets and control measures; impacts on point and area source emissions; any changes to established safety margins (see §93.101 for definition), and reasons for the changes (including the basis for any changes to emission factors or estimates of vehicle miles traveled).
                                       Y
On June 14, 1993, ADEQ submitted the "Final State Implementation Plan for the Nogales PM10 Nonattainment Area." For the document please see the following URL  <http://www.azdeq.gov/environ/air/plan/download/nogpm10sip_061993.pdf>

The 1993 SIP did not contain motor vehicle emissions budgets, as EPA had not promulgated the conformity regulations required by the 1990 Clean Air Act Amendments in 1993. So while the 2012 Nogales SIP revises and updates the 1993 Nogales SIP, it did not update or revise any budget for conformity purposes.
Sec. 93.118(e)(5)
EPA has reviewed the State's compilation of public comments and response to comments that are required to be submitted with any implementation plan.
                                       Y
ADEQ compiled public comments submitted during the June 21, 2012 public hearing and during the May to June 2012 and July to August 2012 public comment periods.  Any written and verbal comments received during the public comment period and public hearing on the 2012 Nogales Attainment Plan were submitted with the final SIP documents; see appendix K of the submitted plan.
EPA will review any comments that ADEQ receives on the SIP and ADEQ's responses, and will take into account comments that substantively change the level of the budgets or affect our adequacy finding.


[Federal Register Volume 75, Number 238 (Monday, December 13, 2010)]
[Notices]
[Pages 77693-77694]
[FR Doc No: 2010-31178]

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

Federal Aviation Administration

Noise Exposure Map Notice; Manchester-Boston Regional Airport,
Manchester, NH

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice.

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

SUMMARY: The Federal Aviation Administration (FAA) announces its
determination that the noise exposure maps for Manchester-Boston
Regional Airport, as submitted by the City of Manchester, New
Hampshire, under the provisions of Title I of the Aviation Safety and
Noise Abatement Act of 1979 (Pub. L. 96-193) and 14 CFR part 150, are
in compliance with applicable requirements.

DATES: Effective Date: The effective date of the FAA's determination on
the noise exposure maps is December 3, 2010.

FOR FURTHER INFORMATION CONTACT: Lisa J. Lesperance or Richard
Doucette, Federal Aviation Administration, New England Region, Airports
Division, 12 New England Executive Park, Burlington, Massachusetts
01803.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA finds
that the noise exposure maps submitted for Manchester-Boston Regional
Airport are in compliance with applicable requirements of Part 150,
effective December 3, 2010.
    Under Section 103 of Title I of the Aviation Safety and Noise
Abatement Act of 1979 (hereinafter referred to as ``the Act''), an
airport operator may submit to the FAA noise exposure maps that meet
applicable regulations and that depict non-compatible land uses as of
the date of submission of such maps, a description of projected
aircraft operations, and the ways in which such operations will affect
such maps. The Act requires such maps to be developed in consultation
with interested and affected parties in the local community, government
agencies, and persons using the airport.
    An airport operator who has submitted such noise exposure maps that
are found by FAA to be in compliance with the requirements of Federal
Aviation Regulation (FAR) Part 150, promulgated pursuant to Title I of
the Act, may submit a noise compatibility program for FAA approval that
sets forth the measures the operator has taken, or proposes, for the
introduction of additional non-compatible uses.
    The FAA has completed its review of the noise exposure map and
related descriptions submitted by the City of Manchester, New
Hampshire. The specific maps under consideration were Figure 4.2-1, and
Figure 4.3-1 in the submission. The FAA has determined that these maps
for Manchester-Boston Regional Airport are in compliance with
applicable requirements. This determination is effective on December 3,
2010.
    FAA's determination on an airport operator's noise exposure maps is
limited to a finding that the maps were developed in accordance with
the procedures contained in Appendix A of FAR Part 150. Such
determination does not constitute approval of the applicant's data,
information or plans, or a commitment to approve a noise compatibility
program or to fund the implementation of that program.
    If questions arise concerning the precise relationship of specific
properties to noise exposure contours depicted on a noise exposure map
submitted under Section 103 of the Act, it should be noted that the FAA
is not involved in any way in determining the relative locations of
specific properties with regard to the depicted noise contours, or in
interpreting the noise exposure maps to resolve questions concerning,
for example, which properties should be covered by the provisions of
Section 107 of the Act. These functions are inseparable from the
ultimate land use control and planning responsibilities of local
government. These local responsibilities are not changed in any way
under Part 150 or through FAA's review of a noise exposure map.
Therefore, the responsibility for the detailed overlaying of noise
exposure contours onto the map depicting properties on

the surface rests exclusively with the airport operator that submitted
the map or with those public agencies and planning agencies with which
consultation is required under Section 103 of the Act. The FAA has
relied on the certification by the airport operator, under Section
150.21 of FAR Part 150, that the statutorily required consultation has
been accomplished.
    Copies of the noise exposure maps and of the FAA's evaluation of
the maps are available for examination at the following locations:

City of Manchester, Manchester-Boston Regional Airport, One Airport
Road, Suite 300, Manchester, NH 03103.
Federal Aviation Administration, New England Region, Airports Division,
12 New England Executive Park, Burlington, Massachusetts 01803.

    Questions may be directed to the individual named above under the
heading: FOR FURTHER INFORMATION CONTACT.

    Issued in Burlington, Massachusetts on December 3, 2010.
Michel J. Hovan,
Acting Manager, Airports Division.
[FR Doc. 2010-31178 Filed 12-10-10; 8:45 am]
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[Federal Register Volume 85, Number 112 (Wednesday, June 10, 2020)]
[Notices]
[Pages 35494-35495]
[FR Doc No: 2020-12507]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No.--2020-45]

Petition for Exemption; Summary of Petition Received; Airlines
for America

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

ACTION: Notice.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion or omission of information in the summary
is intended to affect the legal status of the petition or its final
disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before June 15, 2020.

ADDRESSES: Send comments identified by docket number FAA-2020-0372
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Keira Jones,<PHONE_NUMBER>, Office of
Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on June 4, 2020.
Brandon Roberts,
Acting Executive Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2020-0372.
    Petitioner: Airlines for America.
    Section(s) of 14 CFR Affected: Sec. Sec.  121.311(g), 121.333(f),
121.391(d), and 121.573(a).
    Description of Relief Sought: The petitioner, Airlines for America,
Inc. (A4A), on behalf of its member airlines petitions the Federal
Aviation Administration (FAA) for an extension of Exemption No. 18522
(Docket No. FAA-2020-0372) until September 30, 2020. This exemption is
scheduled to expire on June 30, 2020. The relief granted by Exemption
18522 has been in effect since April 08, 2020.
    Exemption 18522 provides relief, under certain conditions and
limitations, from 14 CFR 121.311(g), 121.333(f), 121.391(d), and
121.573(a) to the extent necessary to allow relief for flight
attendants to relocate from the seats they would normally occupy in
order to comply with recommendations from the World Health Organization
(WHO) and Centers for Disease Control and Prevention (CDC) concerning
proximity to other people. In addition, this relief from certain
requirements of the regulation concerning passenger briefings excuses
crewmembers from demonstrating the use of oxygen dispensing equipment
and donning and inflating a life preserver.

[FR Doc. 2020-12507 Filed 6-9-20; 8:45 am]
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