[Federal Register Volume 76, Number 84 (Monday, May 2, 2011)]
[Notices]
[Pages 24469-24470]
[FR Doc No: 2011-10524]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

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

    Docket Numbers: ER10-3329-003.
    Applicants: Round Rock Energy LP.
    Description: Round Rock Energy LP submits tariff filing per 35:
Round Rock Energy, LP FERC Electric Tariff Schedule No. 1 to be
effective 4/5/2011.
    Filed Date: 04/06/2011.
    Accession Number: 20110406-5150.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 3, 2011.

    Docket Numbers: ER11-2492-001.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, L.L.C. submits tariff filing per
35: Compliance Filing per Order in Docket No. ER11-2492 to be effective
4/26/2011.
    Filed Date: 04/26/2011.
    Accession Number: 20110426-5133.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 17, 2011.

    Docket Numbers: ER11-3427-000.
    Applicants: Unitil Power Corp.
    Description: Unitil Power submits Rate Schedule FERC No. 1, the
Amended Unitil System Agreement, Appendix 1, Section D.
    Filed Date: 04/22/2011.
    Accession Number: 20110425-0203.
    Comment Date: 5 p.m. Eastern Time on Friday, May 13, 2011.

    Docket Numbers: ER11-3433-000.
    Applicants: Florida Power Corporation.
    Description: Florida Power Corporation submits tariff filing per
35.13(a)(2)(iii: Rate Schedule No. 119 of Florida Power Corporation to
be effective 1/1/2011.
    Filed Date: 04/26/2011.
    Accession Number: 20110426-5092.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 17, 2011.

    Docket Numbers: ER11-3434-000.
    Applicants: Wabash Valley Power Association, Inc.
    Description: Wabash Valley Power Association, Inc. submits tariff
filing per 35: WVPA--Section 3--Rate Schedules--Formulary Rate Tariff
Volume No. 1 to be effective 4/26/2011.
    Filed Date: 04/26/2011.
    Accession Number: 20110426-5107.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 17, 2011.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above, do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets the applicable criteria to be a
qualifying facility. Intervention and/or protest do not lie in dockets
that are qualifying facility self-certifications or self-
recertifications. Any person seeking to challenge such qualifying
facility status may do so by filing a motion pursuant to 18 CFR
292.207(d)(iii). Intervention and protests may be filed in response to
notices of qualifying facility dockets other than self-certifications
and self-recertifications.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies

of the intervention or protest to the Federal Energy Regulatory
Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: April 26, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-10524 Filed 4-29-11; 8:45 am]
BILLING CODE 6717-01-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Tony Kish,<PHONE_NUMBER>

Syngenta Crop Protection, LLC

6F8445

	EPA has received a pesticide petition (6F8445) from Syngenta Crop
Protection, LLC, P.O. Box 18300, Greensboro, NC 27419-8300 requesting,
pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180

	by establishing a tolerance for residues of

	Difenoconazole (1
[2-[2-chloro-4-(4-chlorophenoxy)]phenyl-4-methyl-1,3-dioxolan-2-ylmethyl
]-1H-1,2,4,-triazole) in or on the raw agricultural commodity Cottonseed
subgroup 20C at 0.40 parts per million (ppm); Cotton, gin byproducts at
15 parts per million (ppm), rice, grain at 7 parts per million (ppm) and
rice, wild, grain at 7 parts per million (ppm); Syngenta also proposes
that the currently established tolerance for residues of difenoconazole
in/on cotton, undelinted seed (0.05 ppm) for registered uses of
difenoconazole as a seed treatment be removed from 40 CFR §180.475,
because the proposed tolerance in/on these commodities reflecting foliar
uses will be adequate to cover the seed treatment uses.

Syngenta further requests that the current tolerance for cotton, gin
byproducts be amended from 0.05 ppm to the proposed 15 ppm.

EPA has determined that the petition contains data or information
regarding the elements set forth in section 408 (d)(2) of  FDDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data supports granting of the petition.
Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. The nature of the residues in plants is understood
for the purpose of the proposed tolerance.  The metabolism of
14C-difenoconazole has been studied using both phenyl and triazole
labels in wheat, tomatoes, potatoes, grapes, and spring rape.  The
metabolic pathway was the same in these four separate and distinct
crops.  Therefore, the metabolism of difenoconazole is considered to be
adequately understood for all crops, per EPA Test Guideline 860.1300.

	2. Analytical method. Syngenta Crop Protection, LLC has submitted a
practical analytical method (AG-575B, master record identification
(MRID) No. 42806504) for detecting and measuring levels of
difenoconazole in or on food with a limit of quantitation (LOQ) that
allows monitoring of food with residues at or above the levels set in
the proposed tolerances.  Residues are quantified by gas chromatography
equipped with a nitrogen-phosphorous detector.  EPA has validated this
method and copies have been provided to FDA for insertion into pesticide
analytical manual (PAM) II. Method REM 147.08 (MRID 46950222) is also
available for enforcement method, for the determination of residues of
difenoconazole in crops. Residues are qualified by liquid chromatography
(LC)/mass spectrometry (MS)/(MS) The method is available to anyone who
is interested, and may be obtained from the Field Operations Division,
Office of Pesticide Programs.  Syngenta Crop Protection, LLC has
submitted a practical analytical method (AG-544A, MRID-43292401) for
detecting and measuring levels of difenoconazole in or on cattle tissues
and milk and poultry tissues and eggs, with a LOQ that allows monitoring
of food with residues at or above the levels set in the proposed
tolerances.  EPA has validated this method and copies have been provided
to FDA for insertion into PAM II.  The method is available to anyone who
is interested, and may be obtained from the Field Operations Division,
Office of Pesticide Programs.  Tolerances in meat, milk, poultry or eggs
were established for enforcement purposes.

	3. Magnitude of residues. Syngenta conducted adequate magnitude of
residue trials under OPPTS 860.1500 to support the requested uses of
difenoconazole. These

residue trials satisfy the requested tolerances on rice and cotton.

B. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk.  EPA has also considered
available information concerning the variability of the sensitivities of
major identifiable subgroups of consumers, including infants and
children.  Specific information on the studies received and the nature
of the toxic effects caused by difenoconazole as well as the
no-observed-adverse-effect-level (NOAEL) from the toxicity studies can
be found at the following website: http://www.regulations.gov on page 37
of the document titled “Difenoconazole: Human Health Risk Assessment
for Proposed New Foliar Uses on Globe Artichoke, Ginseng and Greenhouse
Grown Cucumbers and Conversion of the Established Foliar Uses/Tolerances
for Stone Fruit Group 12 and Tree Nut Crop group 14 to Stone Fruit Group
12-12 and Tree Nut Group 14-12,’’ in Docket ID Number
EPA–HQ–OPP–2014-0470.  A summary of the toxicological endpoints
for difenoconazole used for human risk assessment is discussed in Table
1 of the final rule published in the Federal Register on April 2, 2015
(FR volume 80, No. 63, pages 17697-17703) (FRL-9923-82).

	1. Acute toxicity.  [Insert text]

	2. Genotoxicty. [Insert text]

	3. Reproductive and developmental toxicity. [Insert text]

	4. Subchronic toxicity. [Insert text]

	5. Chronic toxicity. [Insert text.]

	6. Animal metabolism. [Insert text.]

	7. Metabolite toxicology. [Insert text.]

	8. Endocrine disruption. [Insert text.]

C. Aggregate Exposure

	1. Dietary exposure. Tier III acute, short-term, and chronic dietary
exposure evaluations were performed for difenoconazole using the Dietary
Exposure Evaluation Model (DEEM-FCID™ Version 4.02) from EPA and
consumption data from the USDA NHANES “What We Eat in America”
survey, 2005-2010.  These difenoconazole exposure assessments included
all current uses plus proposed new foliar uses on rice and cotton.
These assessments utilized residue data from field trials where
difenoconazole was applied at the maximum intended use rate and samples
were harvested at the minimum pre-harvest interval (PHI) to obtain
maximum residues.  Empirically derived processing factors were used in
these assessments when available; all other processing factors used the
DEEM-FCIDTM Version 7.87 defaults.  Secondary residues in beef liver and
kidney were estimated based on “maximum reasonably balanced diets”
and transfer information from feeding studies. Percent crop treated
(%CT) values were estimated based upon economic, pest, and competitive
pressures.  Drinking water estimates were selected using the higher of
the estimated drinking water concentrations (EDWCs) for surface and
ground water.

	i. Food. Acute exposure.  Acute (food only) risk assessments for
difenoconazole were performed for all population subgroups using an
acute reference dose (aRfD) of 0.25 mg/kg-bw/day, based upon a
neurotoxicity study in rats with a no observed adverse effect level
(NOAEL) of 25 mg/kg-bw/day and an uncertainty factor (UF) of 100X. The
100X safety factor includes intra- and inter-species variations; no
additional FQPA safety factor was applied.  For the purpose of the
aggregate risk assessment, the exposure value was expressed in terms of
margin of exposure (MOE), which was calculated by dividing the NOAEL by
the exposure for each population subgroup.  In addition, exposure was
expressed as a percent of the acute reference dose (%aRfD).  At the
99.9th percentile, acute (food only) exposure to the U.S. population
resulted in a MOE of 559 (17.9% of the aRfD of 0.25 mg/kg-bw/day).  The
most exposed sub population was children (1-2 years old) with a MOE of
281 (35.5% of the aRfD of 0.25 mg/kg-bw/day).  Since the Benchmark MOE
for this assessment was 100 and since the EPA generally has no concern
for exposures above the Benchmark MOE or below 100% of the reference
dose, Syngenta believes that there is a reasonable certainty that no
harm will result from acute dietary (food) exposure to residues arising
from all current and proposed uses for difenoconazole.

Chronic exposure.  Chronic (food only) risk assessment for
difenoconazole were performed for all population subgroups using a
chronic reference dose (cRfD) of 0.01 mg/kg bw/day, based on a combined
chronic toxicity/carcinogenicity study in rats with a no observed
adverse effect level (NOAEL) of 0.96 mg/kg-bw/day and an uncertainly
factor of 100X.  The 100X safety factor includes intra- and
inter-species variations; no additional FQPA safety factor was applied.
For the purpose of the aggregate risk assessment, the exposure values
were expressed in terms of margin of exposure (MOE), which was
calculated by dividing the NOAEL by the exposure for each population
subgroup.  In addition, exposure was expressed as a percent of the
chronic reference dose (%cRfD).  Chronic (food only) exposures to the
U.S. population resulted in a MOE of 996 (9.6% of the cRfD of 0.01
mg/kg-bw/day).  The most exposed sub population was all infants (<1 year
old) with a MOE of 273 (35.2% of the cRfD of 0.01 mg/kg-bw/day).  Since
the Benchmark MOE for this assessment was 100 and since the EPA
generally has no concern for exposures above the Benchmark MOE or below
100% of the reference dose, Syngenta believes that there is a reasonable
certainty that no harm will result from chronic dietary (food) exposure
to residues arising from all current, pending, and proposed uses for
difenoconazole.

Cancer.  A cancer dietary assessment was not conducted.  Difenoconazole
is classified as a Group C, “possible human carcinogen,” with a
non-linear (MOE) approach for human risk characterization (CPRC
Document, 7/27/94, Memo, P. V. Shah, March 3, 2007, HED Doc. No.
0054532).

	ii. Drinking water. The Estimated Drinking Water Concentrations (EDWCs)
of difenoconazole determined as total toxic residues of difenoconazole
(CGA169374) and its degradate, CGA205375, were determined for ground
water using Tier 1 screening models SCI-GROW (version 2.3) and PRZM-GW
(version 1.07) and for surface water using Tier II Surface Water
Concentration Calculator (SWCC v1.106) for terrestrial uses and Modified
Tier 1 Rice Model for aquatic uses. The modelling was conducted to
identify the highest EDWCs of difenoconazole determined as total toxic
residues of difenoconazole (CGA169374) and its degradate, CGA205375,
from the proposed rice and cotton uses and all existing and pending
uses. For ground water, PRZM-GW provided an EDWC of 2.0 ppb for acute
and 0.66 ppb for chronic concentration based on the currently registered
use on turf. For surface water, Modified Tier-I Rice Model provided a
surface water acute EDWC of 33.4.ppb and a surface water chronic EDWC of
30.2 ppb for the proposed rice uses.  Since the surface water EDWCs
exceed the ground water EDWCs, the surface water values were used for
risk assessment purposes and will be considered protective for any
ground water exposure concerns.

Acute Exposure from Drinking Water.  The acute surface water EDWC of
33.4 ppb was input directly into the DEEM-FCID™ software as “water,
direct and indirect, all sources” to model the acute drinking water
exposures.  Exposure contributions at the 99.9th percentile of exposures
were determined by taking the difference between the aggregate (food +
drinking water) exposures and the food (alone) exposures for each
population subgroup.  Acute drinking water exposure U.S. population
resulted in a MOE of 25,432 (0.4% of the aRfD of 0.25 mg/kg-bw/day).
The most exposed sub-population was all infants (<1 year old) with a MOE
of 12,723 (0.8% of the aRfD of 0.25 mg/kg/day).  Since the benchmark MOE
for this assessment was 100 and since EPA generally has no concern for
exposures below 100% of the aRfD, Syngenta believes that there is a
reasonable certainty that no harm will result from acute drinking water
exposure to residues arising from all registered and proposed uses for
difenoconazole.

Chronic Exposure from Drinking Water.  The chronic surface water EDWC of
30.2 ppb was input directly into the DEEM-FCID software as “water,
direct and indirect, all sources” to model the chronic drinking water
exposures.  Chronic drinking water exposure to the U.S. population
resulted in a MOE of 1,573 (6.1% of the cRfD of 0.01 mg/kg-bw/day).
Chronic drinking water exposure to the most exposed sub-population (all
infants, <1 year old) resulted in a MOE of 421 (22.8% of the cRfD of
0.01 mg/kg bw/day).  Since the Benchmark MOE for this assessment was 100
and since EPA generally has no concern for exposures below 100% of the
cRfD, Syngenta believes that there is a reasonable certainty that no
harm will result from chronic drinking water exposure to residues
arising from all registered and proposed uses for difenoconazole.

	2. Non-dietary exposure. The use of difenoconazole on ornamentals and
flower gardens (Inspire®, Ready-to-Use spray) and golf courses (Quadris
Top™, Heritage Top™, Briskway™) may result in residential handler
or post application exposures to selected subgroups.  A short-term
toxicological dermal and inhalation endpoint of 1.25 mg/kg-bw/day was
selected based upon the no observed adverse effect level (NOAEL) from a
2-generation reproductive study in rats with an uncertainty factor of
100X, which includes intra- and inter-species variations; no additional
FQPA safety factor was applied.  Exposure values were expressed in terms
of margin of exposure (MOE), which was calculated by dividing the NOAEL
by the exposure for each subgroup.  Adult gardeners (19+ years old) were
most exposed via post-application exposures from treated gardens, with a
short-term MOE of 251.  Youth gardeners (6-11 years old) were most
exposed via post-application exposures from treated gardens, with a
short term MOE of 367.  Youth golfers (11-16 years old) were most
exposed via post application exposures from treated golf course turf,
with a short-term MOE of 2,659.  Residential exposure assessments were
performed for difenoconazole to evaluate exposures resulting from
off-site drift of agricultural products into residential areas.
Incidental exposure to consumers from spray drift from non-residential
uses were not included in the aggregate consumer risk; this approach
agrees with the EPA’s current policy and practice.  Since the
Benchmark MOE for this assessment was 100 and since the EPA generally
has no concern for exposures above the Benchmark MOE, Syngenta believes
that there is a reasonable certainty that no harm will result from
short-term residential exposure to residues arising from all current,
pending, and proposed uses for difenoconazole.

D. Cumulative Effects

	Cumulative Exposure to Substances with a Common Mechanism of Toxicity.
Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider
“available information” concerning the cumulative effects of a
particular pesticide’s residues and “other substances that have a
common mechanism of toxicity”.  An ongoing series of studies being
conducted by the U.S. Triazole Task Force (USTTF) are designed to
provide the Agency with more complete toxicological and residue
information for 1,2,4 triazole and two conjugates, triazolylalanine and
triazolyl acetic acid, metabolites common to most of the triazole
fungicides.  Upon completion of review of those data, EPA will prepare a
more sophisticated assessment based on the revised toxicological and
exposure databases.  For the purposes of this tolerance action, the EPA
has not assumed that difenoconazole has a common mechanism of toxicity
with other substances.

E. Safety Determination

	1. U.S. population. The acute dietary exposure analysis (food plus
water) showed that exposure from all current and proposed uses of
difenoconazole would result in a MOE of 547 (18.3% of the aRfD of 0.25
mg/kg-bw/day) for the U.S. population, which exceeds the Benchmark MOE
of 100.  For the short-term aggregate exposure analysis the
corresponding food, water and residential MOEs were aggregated using the
inverse MOE approach.  The short-term aggregate exposure analysis (food,
drinking water, and residential) showed that exposure from all current
and proposed uses of difenoconazole resulted in a MOE of 191 for the
U.S. population, which exceeds the Benchmark MOE of 100.  The chronic
dietary exposure analysis (food plus water) showed that exposure from
all current and proposed uses of difenoconazole resulted in a MOE of 610
(15.7% of the cRfD of 0.01 mg/kg-bw/day) for the U.S. population, which
exceeds the Benchmark MOE of 100.  Based on the completeness and
reliability of the toxicity data supporting these petitions, Syngenta
believes that there is a reasonable certainty that no harm will result
from aggregate exposure to residues arising from all current and
proposed uses of difenoconazole, including anticipated dietary exposure
from food, water, and all other types of non-occupational residential
exposures.

	2. Infants and children. The acute dietary exposure analysis (food plus
water) showed that exposure from all current, pending and proposed uses
of difenoconazole would result in a MOE of 278 (36.0% of the aRfD of
0.25 mg/kg-bw/day) for the most sensitive population subgroup, children
1-2 years old, which exceeds the Benchmark MOE of 100.  For the
short-term aggregate exposure analysis the corresponding food, water and
residential MOEs were aggregated using the inverse MOE approach.  The
short term aggregate (food, drinking water, and residential) MOE was 215
for all infants (<1 year), which exceeds the Benchmark MOE of 100.  The
chronic dietary exposure analysis (food plus water) showed that exposure
from all current, pending, and proposed uses of difenoconazole resulted
in a MOE of 166 (58.0% of the cRfD of 0.01 mg/kg-bw/day) for the most
sensitive population subgroup, all infants <1 year old, which exceeds
the Benchmark MOE of 100.  Based on the completeness and reliability of
the toxicity data supporting these petitions, Syngenta believes that
there is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to residues arising from all current
and proposed uses of difenoconazole, including anticipated dietary
exposure from food, water, and all other types of non-occupational
exposures.

F. International Tolerances

	Codex Alimentarius Commission established Maximum Residue Limits (MRLs)
for difenoconazole in various agricultural commodities including
asparagus, banana, beans, except broad bean and soya bean,  broccoli,
Brussels sprouts, cabbages, head, carrot, cauliflower,  celeriac,
celery, cherries, edible offal (mammalian), eggs, garlic,  ginseng,
grapes, leek, lettuce, head, lettuce, leaf, mango, meat, milks,
nectarine, olives, papaya, passion fruit, peach, peas (pods and
succulent/immature seeds), plums (including prunes), pome fruits,
potato, poultry meat, poultry, edible offal of, rape seed, soya bean
(dry), sugar beet, sunflower seed, tomato, tree nuts, wheat, and wheat
straw and fodder, dry..

 PAGE

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[Federal Register: February 19, 2008 (Volume 73, Number 33)]
[Notices]
[Page 9116-9117]
[DOCID:fr19fe08-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. P-11841-002]

Ketchikan Public Utilities; Notice of Settlement Agreement and
Soliciting Comments

February 11, 2008.
    Take notice that the following settlement agreement has been filed
with the Commission and is available for public inspection.
    a. Type of Application: Settlement Agreement.
    b. Project No.: P-11841-002.
    c. Date Filed: February 8, 2008.
    d. Applicant: Ketchikan Public Utilities.
    e. Name of Project: Whitman Lake Hydroelectric Project.
    f. Location: The project would be located on Whitman Creek,
approximately 4 miles east of the City of Ketchikan, Alaska. The
project would occupy 155.8 acres of lands of the United States, 155
acres administered by the U.S. Department of Agriculture, Forest
Service and 0.8 acres administered by the U.S. Bureau of Land
Management.
    g. Filed Pursuant to: Rule 602 of the Commission's Rules of
Practice and Procedure, 18 CFR 385.602.
    h. Applicant Contact: Ms. Jennifer Soderstrom, Ketchikan Public
Utilities, 2930 Tongass Avenue, Ketchikan, AK 99901,<PHONE_NUMBER>.
    i. FERC Contact: Kenneth Hogan at<PHONE_NUMBER>, or
<EMAIL_ADDRESS>
    j. Deadline for filing comments: 20 days from the date of this
notice. Reply comments are due 30 days from the date of this notice.
    k. All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    Comments may be filed electronically via the Internet in lieu of
paper. The Commission strongly encourages electronic filings. See 18
CFR 385.2001(a)(1)(iii) and the instructions

on the Commission's Web site (http://www.ferc.gov) under the ``e-

Filing'' link.
    l. Ketchikan Public Utilities (KPU) filed the Settlement Agreement
on behalf of itself and the other signatories to the Settlement
Agreement (The Alaska Department of Fish and Game, Alaska Department of
Natural Resources, and Southern Southeast Region Aquaculture
Association). The purpose of the Settlement Agreement was to permit and
enhance the multiple uses of the water of Whitman Lake in a manner that
promotes the public interest consistent with the economic viability of
the power operations, the water supply features, the feasibility of the
fish hatchery operations, and all commitments in existing contracts.
The signatories, through KPU, request that the Commission consider the
protection, mitigation, and enhancement measures outlined in the
Settlement Agreement in the Final Environmental Assessment for the
proposed project and that the Commission includes them in any license
issued for the proposed Whitman Lake Hydroelectric Project.
    m. A copy of the settlement agreement is available for review at
the Commission on the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''

link. Enter the docket number (P-11841) in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at 1-866-208-3676, or for TTY,

(202) 502-8659. A copy is also available for inspection and
reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp
 to be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
contact FERC Online Support.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-2992 Filed 2-15-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 103 (Tuesday, May 29, 2012)]
[Notices]
[Page 31677]
[FR Doc No: 2012-13069]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

FEDERAL REGISTER CITATION OF PREVIOUS ANNOUNCEMENT: [77 FR 30338, May
22, 2012].

STATUS: Closed Meeting.

PLACE: 100 F Street NE., Washington, DC.

DATE AND TIME OF PREVIOUSLY ANNOUNCED MEETING: May 24, 2012 at 2:00
p.m.

CHANGE IN THE MEETING: Additional Item.
    The following matter will also be considered during the 2:00 p.m.
Closed Meeting scheduled for Thursday, May 24, 2012:
    A personnel matter.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions as set
forth in 5 U.S.C. 552b(c)(2) and (6) and 17 CFR 200.402(a)(2) and (6),
permit consideration of the scheduled matter at the Closed Meeting.
    Commissioner Walter, as duty officer, voted to consider the item
listed for the Closed Meeting in closed session, and determined that no
earlier notice thereof was possible.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items. For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact the Office of the Secretary at<PHONE_NUMBER>.

    Dated: May 24, 2012.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-13069 Filed 5-24-12; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 143 (Thursday, July 29, 2021)]
[Notices]
[Pages 40850-40851]
[FR Doc No: 2021-16178]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0554]

Actavis Elizabeth LLC, et al.; Withdrawal of Approval of 85
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 85 abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.

DATES: Approval is withdrawn as of August 30, 2021.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec.  314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
ANDA 040113............  Chlorzoxazone Tablets,   Actavis Elizabeth LLC
                          500 milligrams (mg).     (an indirect, wholly
                                                   owned subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.), 400
                                                   Interpace Pkwy.,
                                                   Building A,
                                                   Parsippany, NJ 07054.
ANDA 040152............  Carisoprodol Tablets,    Watson Laboratories,
                          350 mg.                  Inc. (an indirect,
                                                   wholly owned
                                                   subsidiary of Teva
                                                   Pharmaceuticals USA,
                                                   Inc.), 400 Interpace
                                                   Pkwy., Building A,
                                                   Parsippany, NJ 07054.
ANDA 040184............  Trihexyphenidyl           Do.
                          Hydrochloride (HCl)
                          Tablets, 2 mg and 5 mg.
ANDA 040212............  Estradiol Tablets, 0.5    Do.
                          mg, 1 mg, 1.5 mg, and
                          2 mg.
ANDA 040276............  Phentermine HCl          Actavis Elizabeth LLC.
                          Tablets, 37.5 mg.
ANDA 040296............  Estropipate Tablets,     Barr Laboratories,
                          0.75 mg, 1.5 mg, and 3   Inc. (an indirect,
                          mg.                      wholly owned
                                                   subsidiary of Teva
                                                   Pharmaceuticals USA,
                                                   Inc.), 400 Interpace
                                                   Pkwy., Building A,
                                                   Parsippany, NJ 07054.
ANDA 060704............  Tetracycline HCl         Ivax Pharmaceuticals,
                          Capsules, 250 mg and     Inc. (an indirect,
                          500 mg.                  wholly owned
                                                   subsidiary of Teva
                                                   Pharmaceuticals USA,
                                                   Inc.), 400 Interpace
                                                   Pkwy., Building A,
                                                   Parsippany, NJ 07054.
ANDA 062343............  Tetracycline HCl         Watson Laboratories,
                          Capsules, 250 mg and     Inc.
                          500 mg.
ANDA 062581............  Doxycycline Hyclate      Teva Pharmaceuticals
                          Tablets, Equivalent to   USA, Inc., 400
                          (EQ) 100 mg base.        Interpace Pkwy.,
                                                   Building A,
                                                   Parsippany, NJ 07054.
ANDA 070152............  Diazepam Tablets, 2 mg.  Barr Laboratories,
                                                   Inc.
ANDA 070153............  Diazepam Tablets, 5 mg.  Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 070154............  Diazepam Tablets, 10 mg  Barr Laboratories,
                                                   Inc.
ANDA 070511............  Metoclopramide HCl       Watson Laboratories,
                          Tablets, EQ 10 mg base.  Inc.
ANDA 070548............  Propranolol HCl           Do.
                          Tablets, 10 mg.
ANDA 070706............  Diazepam Tablets, 5 mg.  Actavis Elizabeth LLC.
ANDA 070707............  Diazepam Tablets, 10 mg   Do.
ANDA 070781............  Diazepam Tablets, 2 mg.   Do.
ANDA 070856............  Verapamil HCl Tablets,   Watson Laboratories,
                          120 mg.                  Inc.
ANDA 070944............  Oxazepam Capsules, 15    Ivax Pharmaceuticals,
                          mg.                      Inc.
ANDA 070964............  Clonidine HCl Tablets,   Watson Laboratories,
                          0.2 mg.                  Inc.
ANDA 070965............  Clonidine HCI Tablets,    Do.
                          0.1 mg.
ANDA 070985............  Ibuprofen Tablets, 200   Merro Pharmaceutical
                          mg.                      Co., Ltd., SciRegs
                                                   International, Inc.,
                                                   Authorized U.S.
                                                   Agent, 6333
                                                   Summercrest Dr.,
                                                   Columbia, MD 21045.
ANDA 071019............  Verapamil HCl Tablets,   Actavis Elizabeth LLC.
                          80 mg.
ANDA 071050............  Morphine Sulfate         Fresenius Kabi USA,
                          Injection, 0.5 mg/       LLC, Three Corporate
                          milliliters (mL).        Dr., Lake Zurich, IL
                                                   60047.
ANDA 071086............  Lorazepam Tablets, 0.5   Watson Laboratories,
                          mg.                      Inc.
ANDA 071087............  Lorazepam Tablets, 1 mg   Do.
ANDA 071088............  Lorazepam Tablets, 2 mg   Do.
ANDA 071366............  Verapamil HCl Tablets,    Do.
                          80 mg.
ANDA 071367............  Verapamil HCl Tablets,    Do.
                          120 mg.
ANDA 071476............  Betamethasone            Teva Pharmaceuticals
                          Dipropionate Cream, EQ   USA, Inc.
                          0.05% base.
ANDA 071477............  Betamethasone             Do.
                          Dipropionate Ointment,
                          EQ 0.05% base.
ANDA 071479............  Carbamazepine Tablets,   PLIVA Inc. (an
                          200 mg.                  indirect, wholly
                                                   owned subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.), 400
                                                   Interpace Pkwy.,
                                                   Building A,
                                                   Parsippany, NJ 07054.
ANDA 071696............  Carbamazepine Tablets,   Actavis Elizabeth LLC.
                          200 mg.
ANDA 071969............  Triamterene and          Watson Laboratories,
                          Hydrochlorothiazide      Inc.
                          Tablets, 50 mg and 75
                          mg.
ANDA 072124............  Verapamil HCl Tablets,   PLIVA Inc.
                          80 mg.
ANDA 072125............  Verapamil HCl Tablets,    Do.
                          120 mg.
ANDA 072333............  Prazosin HCl Capsules,   Watson Laboratories,
                          EQ 2 mg base.            Inc.
ANDA 072352............  Prazosin HCl Capsules,    Do.
                          EQ 1 mg base.
ANDA 072418............  Amoxapine Tablets, 25     Do.
                          mg.
ANDA 072419............  Amoxapine Tablets, 50     Do.
                          mg.

ANDA 072420............  Amoxapine Tablets, 100    Do.
                          mg.
ANDA 072421............  Amoxapine Tablets, 150    Do.
                          mg.
ANDA 072609............  Prazosin HCl Capsules,    Do.
                          EQ 5 mg base.
ANDA 072751............  Verapamil HCl Tablets,   PLIVA Inc.
                          40 mg.
ANDA 072923............  Verapamil HCl Tablets,   Watson Laboratories,
                          40 mg.                   Inc.
ANDA 072953............  Oxazepam Capsules, 15     Do.
                          mg.
ANDA 072954............  Oxazepam Capsules, 30     Do.
                          mg.
ANDA 073093............  Baclofen Tablets, 20 mg   Do.
ANDA 073122............  Loperamide HCl           Teva Pharmaceuticals
                          Capsules, 2 mg.          USA, Inc.
ANDA 073334............  Amiloride HCl and        Watson Laboratories,
                          Hydrochlorothiazide      Inc.
                          Tablets, EQ 5 mg
                          anhydrous; 50 mg.
ANDA 073352............  Atenolol Tablets, 50 mg   Do.
ANDA 073353............  Atenolol Tablets, 100     Do.
                          mg.
ANDA 073637............  Piroxicam Capsules, 10   Teva Pharmaceuticals
                          mg.                      USA, Inc.
ANDA 073638............  Piroxicam Capsules, 20    Do.
                          mg.
ANDA 074026............  Triamterene and          PLIVA Inc.
                          Hydrochlorothiazide
                          Tablets, 25 mg and
                          37.5 mg.
ANDA 074359............  Butalbital, Aspirin,     Watson Laboratories,
                          Caffeine, and Codeine    Inc.
                          Phosphate Capsules,
                          325 mg, 50 mg, 40 mg,
                          and 30 mg.
ANDA 074405............  Flurbiprofen Tablets,    Teva Pharmaceuticals
                          50 mg and 100 mg.        USA, Inc.
ANDA 074421............  Cyclobenzaprine HCl      PLIVA Inc.
                          Tablets, 10 mg.
ANDA 074436............  Cyclobenzaprine HCl      Watson Laboratories,
                          Tablets, 10 mg.          Inc.
ANDA 074442............  Gemfibrozil Tablets,      Do.
                          600 mg.
ANDA 074479............  Alprazolam Tablets,       Do.
                          0.25 mg, 0.5 mg, and 1
                          mg.
ANDA 074647............  Flurbiprofen Tablets,    PLIVA Inc.
                          50 mg and 100 mg.
ANDA 074762............  Guanfacine HCl Tablets,  Watson Laboratories,
                          EQ 1 mg base and EQ 2    Inc.
                          mg base.
ANDA 074836............  Acyclovir Tablets, 400   IVAX Pharmaceuticals,
                          mg and 800 mg.           Inc.
ANDA 074892............  Etodolac Tablets, 400    Watson Laboratories,
                          mg and 500 mg.           Inc.
ANDA 074955............  Ketorolac Tromethamine    Do.
                          Tablets, 10 mg.
ANDA 074964............  Clonazepam Tablets, 0.5   Do.
                          mg, 1 mg, and 2 mg.
ANDA 075067............  Cromolyn Sodium          Actavis Mid Atlantic
                          Inhalation Solution,     LLC (an indirect,
                          10 mg/mL.                wholly owned
                                                   subsidiary of Teva
                                                   Pharmaceuticals USA,
                                                   Inc.), 400 Interpace
                                                   Pkwy., Building A,
                                                   Parsippany, NJ 07054.
ANDA 075069............  Etodolac Tablets, 400    Watson Laboratories,
                          mg.                      Inc.
ANDA 075262............  Albuterol Sulfate        Actavis Mid Atlantic
                          Syrup, EQ 2 mg base/5    LLC.
                          mL.
ANDA 075284............  Ketorolac Tromethamine   PLIVA Inc.
                          Tablets, 10 mg.
ANDA 081165............  Hydroxyzine Pamoate      Watson Laboratories,
                          Capsules, EQ 25 mg HCl.  Inc.
ANDA 084503............  Hydralazine HCl           Do.
                          Tablets, 50 mg.
ANDA 085054............  Hydrochlorothiazide      Actavis Mid Atlantic
                          Tablets, 25 mg.          LLC.
ANDA 085084............  Prednisone Tablets, 5    Watson Laboratories,
                          mg.                      Inc.
ANDA 085085............  Prednisolone Tablets, 5   Do.
                          mg.
ANDA 085208............  Hydrochlorothiazide      Actavis Elizabeth LLC.
                          Tablets, 50 mg.
ANDA 086710............  Aspirin, Butalbital,      Do.
                          Caffeine Tablets, 325
                          mg, 50 mg, and 40 mg.
ANDA 086813............  Prednisone Tablets, 20   Watson Laboratories,
                          mg.                      Inc.
ANDA 087773............  Prednisone Tablets, 10    Do.
                          mg.
ANDA 088348............  Hydroxyzine HCl           Do.
                          Tablets, 10 mg.
ANDA 088349............  Hydroxyzine HCl           Do.
                          Tablets, 25 mg.
ANDA 088350............  Hydroxyzine HCl           Do.
                          Tablets, 50 mg.
ANDA 088497............  Methylprednisolone       Duramed
                          Tablets, 4 mg.           Pharmaceuticals Inc.
                                                   (an indirect wholly
                                                   owned subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.), 400
                                                   Interpace Pkwy.,
                                                   Building A,
                                                   Parsippany, NJ 07054.
ANDA 089536............  Acetaminophen,           Watson Laboratories,
                          Butalbital, and          Inc.
                          Caffeine Tablets, 325
                          mg, 50 mg, and 40 mg.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
August 30, 2021. Approval of each entire application is withdrawn,
including any strengths and dosage forms inadvertently missing from the
table. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on August 30, 2021 may continue to be dispensed until
the inventories have been depleted or the drug products have reached
their expiration dates or otherwise become violative, whichever occurs
first.

    Dated: July 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16178 Filed 7-28-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: April 12, 2010 (Volume 75, Number 69)]
[Notices]
[Page 18495]
[DOCID:fr12ap10-45]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP10-569-000]

XTO Energy Inc., Cross Timbers Energy Services, Inc.,
Complainants v. Midcontinent Express Pipeline LLC, Respondent; Notice
of Complaint

April 5, 2010.
    Take notice that on April 1, 2010, pursuant to section 5 of the
Natural Gas Act, 15 U.S.C. 717d (2006) and Rule 206 of the Federal
Energy Regulatory Commission's Rules of Practice and Procedure, 18 CFR
385.206 (2009), XTO Energy Inc. and Cross Timbers Energy Services, Inc.
(Complainants) filed a formal complaint against Midcontinent Express
Pipeline LLC (Respondent) alleging that, Respondent (1) charged
reservation rates for firm service without contractual authority and
prior to its facilities properly being placed fully in service and (2)
provided incomplete and incorrect information to the Commission in
seeking authorization to place its facilities in service.
    The Complainants certify that a copy of the complaint has been
served on the contacts for the Respondent.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions or protests must be filed on or before the
comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on April 21, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-8210 Filed 4-9-10; 8:45 am]
BILLING CODE 6717-01-P


John Blouin 08/ 11/ 2003 11: 35 AM To: cc: Subject: Proposed: Incineration Goals and Agenda: Interested Parties FYI: The attached was received from the TRP.

Telomer Incineration Draft Straw Objectives and Agenda 8 August 2 John J. Blouin US EPA Office of Pollution Prevention & Toxics Chemical Engineering Branch Mail Code: 7406M 202 564 8519 / 202 564 8528 ( fax) Draft, 8 August, 2003 Technical Subgroup on Incineration Test Methods for Telomers Introduction The PFOA ECA Plenary session held on July 10, 2003, approved an action plan for the Telomer Workgroup to form a Technical Subgroup on Incineration test methods. This subgroup will assess the adequacy of available incineration test methods so as to inform a technical assessor on the details of Telomer thermal degradation and the potential concurrent formation of PFOA. Where needed, specific approaches to address the unique characteristics of Telomers and Telomer based polymers will be agreed upon.

Goals / Objectives The goals of this Technical Subgroup on Incineration Test Methods for Telomers are:

Identify the scope and goals of proposed incineration testing work toward agreement on a testing protocol that would determine if incineration of Telomers is a potential source of PFOA at operating conditions that are representative of relevant types of waste incinerators.

Work toward identifying a list of representative Telomers and/ or other Telomer treated materials for incineration testing.

Work toward identifying temperatures at which to run the test( s) to represent operating conditions for relevant types of waste incinerators.

Work toward developing a testing protocol using well accepted laboratory scale incineration testing practices and suitable sampling and analytical techniques.

Report back to the Telomers Workgroup regarding the testing details that could be incorporated into an Enforceable Consent Agreement ( ECA) for testing specific Telomer chemicals and/ or other Telomer treated materials.

Meetings Meetings will be held at EPA Headquarters in Washington, DC. The initial meeting will be from 9: 00 to noon on Thursday, August 14, 2003. Attendance may be via conference call or in person. Meeting materials will be distributed one week in advance of the meeting. Draft, 8 August, 2003 Technical Subgroup on Incineration Test Methods for Telomers Tentative Agenda  First Meeting Thursday, August 14, 2003 9: 00 AM to Noon EPA East, Room 4225 1201 Constitution Avenue, NW Washington, DC 20460  Discussion of Goals / Objectives  Review of Recent Related Incineration Studies  Key Elements of Proposed Test Protocol   Test Temperatures   Residence time   Sampling & Analysis   Other  Criteria for choosing Telomer chemicals to be tested  Data Quality Considerations  Next Steps


        Supporting Statement Part B for Information Collection Request
                 EPA ICR No. 2660.01, OMB Control No. 2050-New
            Survey of State Emergency Response Commissions (SERCs)

1.	SURVEY OBJECTIVES, KEY VARIABLES, AND OTHER PRELIMINARIES
	(a)	Survey Objectives
      The Agency is proposing to administer a voluntary survey to State Emergency Response Commissions (SERCs) to collect this information. The information is intended to assist EPA in identifying how EPCRA is being implemented and best practices, challenges, and gaps in meeting requirements. This information is intended to assist EPA in identifying areas where states need assistance in implementing SERC requirements under EPRCA.
      (b)	Key Variables
      Key information for this survey includes:
 A series of questions that ask the SERCs to better characterize their state program (e.g., number of LEPCs)
 A series of yes/no style questions (including check all that apply questions) that ask SERCs to identify which aspects of EPRCA are being implemented
 A series of questions that ask the SERCs to identify how the program is administered at the state and local levels
      (c)	Statistical Approach
      The potential respondent universe are the 56 SERCs (50 states, five territories, and the District of Columbia). EPA plans to solicit responses from all of the 56 SERCs. Response to the survey is voluntary, however, EPA plans to actively pursue responses from each SERC. EPA has determined that a complete, or near complete, set of responses is the most valuable set of information to have for identifying issues and gaps.
      EPA contacted five SERCs and asked them to review the draft survey questions and  provide a burden estimate to complete the survey. All five SERCs responded to EPA's request (Colorado, Maine, Ohio, Oklahoma, and Oregon). Four of the five SERCs provided estimates of the time required to complete the survey:
 Colorado indicated it would take 3-6 hours to complete
 Maine indicated it would take one hour to complete
 Ohio indicated it would take 3-4 hours to complete
 Oklahoma indicated it would take 2 hours to complete
 Oregon did not provide an estimate
      Based on these estimates, EPA has decided to assume that each response will take approximately four hours to complete (i.e., one half-day). This estimate reflects an upper-bound estimate and is based on the feedback obtained during the consultations.
      The Agency expects to use contract support for data collection, tabulation and preliminary analyses of the data and information collected pursuant to this request.  Eastern Research Group, Inc. (ERG; 110 Hartwell Ave., Lexington, MA, 02421) will provide this support. ERG has significant expertise in developing and implementing surveys for EPA and other federal agencies.
      (d)	Feasibility
      During the consultations with SERCs, EPA discussed potential obstacles related to responding to the information collection and impacts on estimated burden. The following two key issues were identified:
            i. Needing to assemble and/or look up the information needed. SERCs indicated that much of the information being asked for was not something a SERC Coordinator would readily remember. Thus, time would be needed to search files and assemble responses. EPA has added time to the burden estimate to account for time to perform these actions. Additionally, from the consultations, EPA used an estimate from the upper end of the time estimates that were provided.
            ii. The time needed to complete the survey. The survey asks 90 questions, some requiring an open-ended response and others asking for detailed listings of information. To account for this, EPA expects to allow for 30 days to complete the survey.
2. 	SURVEY DESIGN
	(a)	Target Population and Coverage
      The target population for this ICR is the 56 SERCs as defined above. The survey is intended to be completed by the SERC coordinator in each state or territory. This survey is intended to census the respondent population.
      (b)	Sample Design
      Not applicable since survey will be distributed to 100% of the potential respondent population.
      (c)	Precision Requirements
      Not applicable since a statistically-based sampling design was not applicable.
      (d)	Questionnaire Design.
      The objective of the survey is to collect information to assist EPA in identifying how EPCRA is being implemented and best practices, challenges, and gaps in meeting requirements. EPA will use this information to identify areas where states need assistance in implementing SERC requirements under EPCRA. Thus, the questionnaire covers all relevant areas of EPCRA for which SERCs are responsible and asks for details on how SERCs are implementing those requirements. The instrument asks 90 detailed questions which, once compiled, will provide a comprehensive picture of how SERCs meet their requirements.
      To design the instrument, EPA developed an initial list of topic areas under EPCRA based on the requirements for SERCs under the Act. EPA then detailed all of the required sub-elements and the relevant implementation details associated with those sub-elements. These topics were then formulated into a set of initial survey questions. EPA then asked ERG, its subcontractor, to review the questions and to refine based on ERG's survey design expertise.
      The survey is designed to be administered via an online data collection portal. For this reason, the questionnaire is formatted in a way that is user-friendly. The layout is clear and the skip patterns are logical and function appropriately. A screenshot of the survey instrument is included in Appendix C this ICR.
      (e) 	Addressing Potential Non-response Bias
      EPA plans to follow up with each of the 56 SERC Coordinators directly to ensure a response from each one. EPA maintains contact information with all SERC Coordinators. Thus, EPA is targeting and expects little to no non-response.
3.	PRETESTS AND PILOT TESTS
      To pilot test the survey, EPA asked five SERCs to review the survey instrument and to provide feedback on the survey questions. This pilot was done as part of the consultation process. The SERCs that participated in the consultation process reviewed the instrument and provided some feedback to EPA. Notably, each SERC indicated that the information would be something that a SERC Coordinator should be able to provide although the survey is long.
4.	COLLECTION METHODS AND FOLLOW-UP
	(a)	Collection Methods
      EPA will collect responses electronically using an online data collection portal (Qualtrics) maintained by its subcontractor, ERG. EPA will review each submittal for completeness and understandability. If items are missing, EPA will follow-up with the SERC to obtain the missing information. The information collected pursuant to this ICR will be maintained electronically in ERG's secure Qualtrics account.
      EPA will notify the public via the Federal Register of the ICR and survey.  Additionally, EPA will provide the SERCs with a pre-notification alerting them to this upcoming data collection effort at least a week ahead of the survey request. This pre-notification will give each SERC Coordinator time to assemble the necessary information and to prepare as needed.
	(b)	Survey Response and Follow-up
      The default target response rate for this survey is 100% because EPA is requesting responses from all potential respondents (56).  The actual estimated response rate (54 respondents; 96%) is based on an assumption that at most two SERC will be unable to respond for various logistical reasons. EPA plans to conduct multiple follow-up requests with the SERCs to obtain the information, including scheduling meetings with the SERC Coordinators to assist them in starting the response process.
5.	ANALYZING AND REPORTING SURVEY RESULTS
	(a)	Data Preparation
      The data will be collected using ERG's online web-based account with Qualtrics, Inc. EPA will have ERG review each entry from each SERC to ensure data are complete and understandable.
	(b)	Analysis
      There are three types of data being collected in survey: fixed response option data (both multiple response and single response), quantitative values (e.g., percent), open-ended lists of items, and open-ended responses. For the fixed response data, EPA will develop tabulations and/or cross-tabulation as needed; each tabulation will provide the count and percentage of total responses for each response option. For the quantitative data, EPA will tabulate means, medians, ranges, and other summary statistics to characterize the distribution of the data across the SERCs. For the open-ended lists, EPA will have ERG develop a coding scheme to group similar list items together. ERG will provide EPA with a coding scheme that indicates which items were groups into which category. EPA will then tabulate the percentage of SERCs that listed each grouped item. Finally, for the open-ended responses, EPA will review each one individually and will also have ERG conduct a qualitative data analysis to identify trends and other themes within those data.
	(c)	Reporting Results
      EPA will produce a summary of the information collection and develop a report that is made available to the SERCs. The report will summarize the collected data and the conclusions that EPA draws from the data.


[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Pages 80312-80314]
[FR Doc No: 2023-25475]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4916]

Anesthesiology and Respiratory Therapy Devices Panel of the
Medical Devices Advisory Committee; Notice of Meeting; Establishment of
a Public Docket; Request for Comments--Pulse Oximeters

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Anesthesiology and Respiratory
Therapy Devices Panel of the Medical Devices Advisory Committee (the
Committee). The general function of the Committee is to provide advice
and recommendations to FDA on regulatory issues. The Committee will
discuss an approach to improve the quality of premarket studies and
associated methods used to evaluate the performance of pulse oximeters
submitted for premarket review, taking into consideration a patient's
skin pigmentation, and patient-reported race and ethnicity. The meeting
will be open to the public. FDA is establishing a docket for public
comment on this document.

DATES: The meeting will be held on February 2, 2024, from 9 a.m. to
6:30 p.m. Eastern Time.

ADDRESSES: All meeting participants will be heard, viewed, captioned,
and recorded for this advisory committee meeting via an online
teleconferencing and/or video conferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings may be
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2023-N-4916. The docket will close on March 4,
2024. Please note that late, untimely filed comments will not be
considered. The https://www.regulations.gov electronic filing system
will accept comments until 11:59 p.m. Eastern Time at the end of March
4, 2024. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are received on or
before that date.
    Comments received on or before January 19, 2024, will be provided
to the Committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is canceled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments as follows:

Electronic Submissions

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

     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-N-4916 for ``Anesthesiology and Respiratory Therapy Devices
Panel of the Medical Devices Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Candace Nalls, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected], or FDA Advisory Committee Information Line,
1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A notice in
the Federal Register about last-minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before the
meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing and/or video
conferencing platform. On February 2, 2024, the Committee will discuss
ongoing concerns that pulse oximeters may be less accurate in
individuals with darker skin pigmentation. The Committee will discuss
an approach to improve the quality of premarket studies and associated
methods used to evaluate the performance of pulse oximeters submitted
for premarket review, taking into consideration a patient's skin
pigmentation, and patient-reported race and ethnicity. The Committee
will discuss the type and amount of data that should be provided by
manufacturers to FDA to evaluate the performance of pulse oximeters
submitted for premarket review, including prescription and over-the-
counter indications, and labeling considerations.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference and/or video conference meeting will
be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link. The meeting will include slide presentations with audio and video
components to allow the presentation of materials in a manner that most
closely resembles an in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the Committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before January 19, 2024, will be provided to the
Committee. Oral presentations from the public will be scheduled between
approximately 1:30 p.m. and 3:30 p.m. Eastern Time. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before January 16, 2024.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by January 17, 2024.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Ann Marie Williams, at [email protected] or 301-
796-5966 at least 7 days in advance of the meeting.

    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the location of advisory committee
meetings are hereby waived to allow for this meeting to take place
using an online meeting platform. This waiver is in the interest of
allowing greater transparency and opportunities for public
participation, in addition to convenience for advisory committee
members, speakers, and guest speakers. No participant will be
prejudiced by this waiver, and the ends of justice will be served by
allowing for this modification to FDA's advisory committee meeting
procedures.

    Dated: November 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25475 Filed 11-16-23; 8:45 am]
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