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ENVIRONMENTAL PROTECTION AGENCY

Notice of Filing of a Pesticide Petition for the Establishment of an
Exemption from the Requirement of a Tolerance for Residues of
Chlorantraniliprole in or on Food Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of an exemption from the
requirement of a tolerance for residues of chlorantraniliprole in or on
food commodities under the Federal Food, Drug, and Cosmetic Act (FFDCA),
as amended by the Food Quality Protection Act of 1996 (FQPA).

FOR FURTHER INFORMATION CONTACT: By mail: [EPA Product Manager], Product
Manager (PM), Registration Division, (7505), Office of Pesticide
Programs, Environmental Protection Agency, Ariel Rios Building 1200
Pennsylvania Avenue, N. W., Washington, DC 20460.  Office location and
telephone number:                   , Arlington, VA.,<PHONE_NUMBER>.
Email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition as
follows proposing the establishment and/or amendment of regulations for
residues of certain pesticide chemicals in or on various raw
agricultural commodities under section 408(d) of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C. 346a (d). EPA has determined that
this petition contains data or information regarding the elements set
forth in section 408(d)(2); 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.

List of Subjects

Environmental Protection, Agricultural Commodities, Food Additives, Feed
Additives, Pesticides and Pests, Reporting and Recordkeeping
Requirements.

Summary of Petition

A summary of the pesticide petition is given below. The petitioner
prepared the summary of the petition.

EPA Registration Division contact: Product Manager, (703) XXX-XXXX

 E. I. DuPont de Nemours and Company, DuPont Crop Protection

[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from
E. I. DuPont de Nemours and Company, DuPont Crop Protection, Wilmington,
Delaware, proposing, 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 to establish an exemption from the requirement of a tolerance for
residues of chlorantraniliprole,
3-bromo-N-[4-chloro-2-methyl-6-[(methylamino)carbonyl]phenyl]-1-(3-chlor
o-2-pyridinyl)-1H-pyrazole-5-carboxamide in or on food and feed
commodities.  EPA has determined that the petition contains data or
information regarding the elements set forth in section 408(d)(2) of the
FFDCA; 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 metabolism of chlorantraniliprole is
adequately understood to support the proposed exemption from the
requirement of tolerances. Studies in apple, lettuce, rice, tomato, and
cotton when treated at proposed label rates showed no significant
metabolites.  The only significant residue is the parent compound.

2. Livestock Metabolism. The metabolism of chlorantraniliprole in
ruminants and poultry is adequately understood to support the exemption
from the requirement of tolerances.  Lactating goat and laying hen
metabolism studies were conducted.  The goat and hen rapidly excreted
>93% and >98% of the dosed radiolabeled residues, respectively.

The metabolic pathway in poultry and ruminant (goat) animals was
consistent. There is no reasonable expectation of transfer of finite
residues of chlorantraniliprole and its metabolites to fat, meat, milk,
and eggs.

3. Analytical method.  Since chlorantraniliprole and its metabolic
degradates are not of toxicological concern, analytical methods are not
applicable.

4. Magnitude of residues. Since chlorantraniliprole and its metabolic
degradates are not of toxicological concern, and this petition is a
request for an exemption from a tolerance, the magnitude of residues is
not applicable.

B. Toxicological Profile

	1. Acute toxicity. Based on EPA criteria, chlorantraniliprole is
classified as follows for Toxicity Categories:

Guideline	Title	Results	Category

870.1100

870.1200

870.1300

870.2400

870.2500

870.2600	Acute Oral Toxicity

Acute Dermal Toxicity

Acute Inhalation Toxicity

Primary Eye Irritation

Primary Dermal Irritation

Skin Sensitization	LD50: >5,000 mg/kg (Rat)

LD50: >5,000 mg/kg (Rat)

LC50: >5.1 mg/L (Rat)

Mild irritation (Rabbit)

No irritation (Rabbit)

Not a sensitizer (Mouse LLNA)	Category IV

Category IV

Category IV

Category IV

Category IV

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

	Formulated products are as equally non-toxic following acute exposures
as is technical chlorantraniliprole.  The acute inhalation toxicity for
the suspension concentrate formulation could not be determined above the
maximum practically attainable atmospheric aerosol concentration of 2
mg/L.

There was no evidence of neurotoxicity in rats following a single limit
dose of 2,000 mg/kg

	2. Genotoxicty.  Chlorantraniliprole has shown no genotoxic activity in
the following listed in vitro and in vivo tests:

Bacterial reverse mutation

In vitro mammalian gene mutation (CHO/HGPRT)

In vitro chromosomal aberration (human lymphocytes)

In vivo mouse micronucleus

	3. Reproductive and developmental toxicity.  In developmental toxicity
studies in rats and rabbits, chlorantraniliprole exhibited no effects on
any parameter in pregnant females or their offspring at levels up to and
including the maximum tested dose of 1,000 mg/kg bw/day.

	No reproductive toxicity was observed in a two-generation reproduction
study with chlorantraniliprole in rats.  No adverse effects were
observed on reproduction, fertility, sperm parameters, estrous cycle,
litter size, pup survival and developmental landmarks up to the maximum
tested dose of 20,000 ppm in the diet.  There were no adverse
histological findings indicative of reproductive toxicity.  There was a
slight reduction in the F1 pup (but not F2 pup) weight during lactation
at the highest dose level (mean maternal intake during lactation equal
to 3,118 mg/kg bw/day); this was attributed, in part, to weight loss in
one dehydrated dam during lactation which had a litter with some of the
lowest pup weights.  The slight change in pup weight was without
subsequent effects since overall body weight, weight gain and
development in F1 rats fed 20,000 ppm were similar to control animals.

	4. Subchronic toxicity.

	Subchronic (90-day) feeding studies were conducted with rats, mice and
dogs. No adverse effects were observed at the highest dietary
concentrations tested of 20,000 ppm in rats (1,188 mg/kg bw/day for
males and 1,526 mg/kg bw/day for females), 7,000 ppm in mice (1,135
mg/kg bw/day for males and 1,539 mg/kg bw/day for females) and 40,000
ppm in dogs (1,163 mg/kg bw/day for males and 1,220 mg/kg bw/day for
females).  Chlorantraniloprole showed no evidence of immunotoxicity in
28-day feeding studies in rats or mice and no evidence of neurotoxicity
in a 90-day feeding study in rats at dietary concentrations greater than
the limit dose of 1,000 mg/kg bw/day.

	A 28-day dermal toxicity study in rats was conducted at doses of 100,
300 and 1,000 mg/kg bw/day.  The NOAEL for male and female rats was 300
mg/kg bw/day based on reductions in body weight gain and food efficiency
at 1,000 mg/kg bw/day.

	No adverse target organ effects were observed in any subchronic
toxicity study.

5. Chronic toxicity.

	Chlorantraniliprole was not carcinogenic in either a 2-year study in
rats or an 18-month study in mice.  The NOAEL for chronic toxicity in
the two-year rat study was 20,000 ppm (805 and 1,076 mg/kg./day in males
and females, respectively) and was based on the absence of any
treatment-related toxicity at any dietary concentration evaluated.

	In mice, there were no adverse effects on any in-life parameter in
either males or females administered chlorantraniliprole up to and
including a maximum dietary concentration of 7,000 ppm for 18 months
(935 and 1,155 mg/kg bw/day, respectively).

	In a one-year feeding study in dogs, the NOAEL was the highest dose
tested, 40,000 ppm (1,164 and 1,233 mg/kg/day in males and females,
respectively).

	6. Rat metabolism.

The absorption of [14C]-chlorantraniliprole in rats was rapid with peak
concentrations occurring at 5-12 hours after single dose administration.
Tissue distribution of the absorbed dose was extensive and indicated low
potential for accumulation.  Excretion was substantially complete by
48-72 hours after dosing (>90%).

  Following 14 days of oral administration 14C residues were readily
eliminated from the plasma and tissues and confirmed minimal potential
for accumulation. The profile of metabolites in urine and feces
indicated extensive metabolism consistent with that observed for the
single dose study.

	7. Metabolite toxicology. Due to the extremely low toxicity of the
parent compound and the extensive metabolism observed in mammalian
systems, chlorantraniliprole metabolites are not expected to result in
any significant toxicity.  Toxicology studies conducted with metabolites
support this conclusion.

	8. Endocrine disruption.  No adverse effects were observed on any
endocrine tissue in short- and long-term studies in rats, mice and dogs.

C. Aggregate Exposure

	1. Dietary exposure -- i. Food.  Residues of chlorantraniliprole and
its metabolic degradates are not of toxicological concern.  Therefore,
dietary exposure through food is not a concern.

	ii. Drinking water.  Residues of chlorantraniliprole and its metabolic
degradates are not of toxicological concern.  Therefore, dietary
exposure through drinking water is not a concern.

	2. Non-dietary exposure.  Residential exposure (non-occupational,
non-dietary exposure to consumers) was conservatively assessed for
dermal post-application exposure (children and adults), and for children
the oral exposures via hand-to-mouth, object-to-mouth, and incidental
ingestion of soil were also assessed.  The margins of exposure (MOE)
greatly exceed the 100-fold MOE required for these routes and from the
combined children’s incidental oral ingestion.  Therefore, residential
non-dietary exposure is not a concern.

D. Cumulative Effects

	It is not necessary at this time to consider cumulative effects because
there is no indication that toxic effects of chlorantraniliprole have a
common mechanism with those of any other chemical compounds.

E. Safety Determination

	1. U.S. population. Based on risk assessments performed using
worst-case exposure assumptions there is a reasonable certainty that no
harm will result to the general population from the aggregate exposure
to chlorantraniliprole.  No additional safety factors are warranted.

	2. Infants and children. Based on the risk assessments performed using
worst-case exposure assumptions there is a reasonable certainty that no
harm will result to the infants and children from the aggregate exposure
to chlorantraniliprole.  No additional safety factors are warranted.

E. I. DuPont de Nemours & Company
            	DPX-E2Y45

	Page   PAGE  5  of   NUMPAGES  5


[Federal Register Volume 80, Number 62 (Wednesday, April 1, 2015)]
[Notices]
[Pages 17426-17428]
[FR Doc No: 2015-07449]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PF15-7-000]

Eagle LNG Partners Jacksonville LLC; Supplemental Notice of
Intent To Prepare an Environmental Impact Statement for the Planned
Jacksonville Project and Request for Comments on Environmental Issues

    On February 24, 2015, the Commission issued a ``Notice of Intent to
Prepare an Environmental Impact Statement for the Planned Jacksonville
Project, Request for Comments on Environmental Issues, and Notice of
Public Scoping Meeting'' (NOI). It has come to our attention that the
environmental mailing list was not provided copies of the NOI;
therefore, we are issuing this Supplemental NOI to extend the scoping
period and provide additional time for interested parties to file
comments on environmental issues.
    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental impact statement (EIS) that
will discuss the environmental impacts of the Jacksonville Project
(Project) involving construction and operation of facilities by Eagle
LNG Partners Jacksonville LLC (Eagle LNG) in Duval County, Florida. The
Commission will use this EIS in its decision-making process to
determine whether the project is in the public convenience and
necessity.
    The Commission and its cooperating agencies continue to gather
input from the public and interested agencies on the project. This
process is referred to as scoping. Your input will help the Commission
staff determine what issues they need to evaluate in the EIS. The
initial NOI identified March 26, 2015 as the close of the scoping
period. Please note that the scoping period is now extended and will
close on April 24, 2015.
    This notice is being sent to the Commission's current environmental
mailing list for this Project. State and local government
representatives should notify their constituents of this planned
Project and encourage them to comment on their areas of concern.
    A fact sheet prepared by the FERC entitled ``An Interstate Natural
Gas Facility On My Land? What Do I Need To Know?'' is available for
viewing on the FERC Web site (www.ferc.gov). This fact sheet addresses
a number of typically asked questions, including the use of eminent
domain and how to participate in the Commission's proceedings.

Summary of the Planned Project

    Eagle LNG proposes to construct, own and operate the Jacksonville
LNG facility located within the City of Jacksonville, Florida, on
industrially zoned land adjacent to the St. Johns River.
    The facility would receive domestically produced natural gas,
transported through existing and expanded local utility pipelines, and
utilize super-cooling to create liquefied natural gas (LNG) for
temporary onsite storage. The Project would include three liquefaction
trains, one (possibly two) LNG storage tanks, and a marine load-out
facility and dock on the St. Johns River that could accommodate small
to mid-size LNG vessels and bunkering barges. LNG would be periodically
loaded for transport onto trucks, containers, or ocean-going vessels,
and marketed for use in U.S. vehicular and high-horsepower engines,
domestic ship fueling (marine bunkering), and international export.
    As currently planned, the Jacksonville Project would consist of the
following facilities:
     Three liquefaction trains, each with a capacity of 0.18
million tons per annum;
     inlet natural gas boost compression;
     interconnect piping (including potential non-
jurisdictional expansion of existing public utility lines);
     one 30,283 cubic meter single containment LNG storage
tank;
     an LNG vessel docking and loading terminal;
     an LNG truck loading area;
     flare stack; and
     power, water, and communications facilities (including
off-site non-jurisdictional facilities leading to the Project site).
    The general location of the Project site is shown in Appendix 1.\1\
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    \1\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of the appendices were sent to all
those receiving this notice in the mail and are available at
www.ferc.gov using the link called ``eLibrary'' or from the
Commission's Public Reference Room, 888 First Street NE.,
Washington, DC 20426, or call<PHONE_NUMBER>. For instructions on
connecting to eLibrary, refer to the last page of this notice.
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Land Requirements for Construction

    The planned Jacksonville Project would encompass a 193 acre site
along the St. Johns River that is currently zoned for industrial
development by the City of Jacksonville, and located in an area that
hosts other bulk fuel terminals. The Project site includes a submerged
land lease covering lands extending approximately 600 feet from the
shoreline into the St. Johns River. Based on the Project's initial
design, the facility construction footprint would occupy approximately
40 of the 193 acres; laydown area requirements during construction are
included within the 40 acres. Eagle LNG is still in the planning phase
for the Jacksonville Project and the required property title
assignments have not been finalized.

The EIS Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the authorization of LNG
facilities under section 3(a) of the Natural Gas Act. NEPA also
requires us \2\ to discover and address concerns the public may have
about proposals. This process is referred to as scoping. The main goal
of the scoping process is to focus the analysis in the EIS on the
important environmental issues. By this notice, the Commission requests
public comments on the scope of the issues to address in the EIS. We
will consider all filed comments during the preparation of the EIS.
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    \2\ ``We,'' ``us,'' and ``our'' refer to the environmental staff
of the Commission's Office of Energy Projects.
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    In the EIS, we will discuss impacts that could occur as a result of
the construction and operation of the planned Project under these
general headings:
     Geology and soils;
     land use;
     water resources and wetlands;
     cultural resources;
     vegetation, fisheries, and wildlife;

     socioeconomics;
     air quality and noise;
     endangered and threatened species;
     public safety and reliability; and
     cumulative impacts.
    We will also evaluate possible alternatives to the planned Project
or portions of the Project, and make recommendations on how to lessen
or avoid impacts on the various resource areas.
    Although no formal application has been filed, we have already
initiated our NEPA review under the Commission's pre-filing process.
The purpose of the pre-filing process is to encourage early involvement
of interested stakeholders and to identify and resolve issues before
the FERC receives an application. As part of our pre-filing review, we
have begun to contact some federal and state agencies to discuss their
involvement in the scoping process and the preparation of the EIS. In
addition, representatives from the FERC participated in the public open
house sponsored by Eagle LNG in Jacksonville, Florida in January 2015
to explain the environmental review process and answer questions to
interested stakeholders.
    The EIS will present our independent analysis of the issues. We
will publish and distribute the draft EIS for public comment. After the
comment period, we will consider all timely comments and revise the
document, as necessary, before issuing a final EIS. To ensure we have
the opportunity to consider and address your comments, please carefully
follow the instructions in the Public Participation section beginning
on page 5 of this notice.
    With this notice, we are asking agencies with jurisdiction by law
and/or special expertise with respect to the environmental issues
related to this Project to formally cooperate with us in the
preparation of the EIS.\3\ Agencies that would like to request
cooperating agency status should follow the instructions for filing
comments provided under the Public Participation section of this
notice. Currently, the U.S. Coast Guard, the U.S. Army Corps of
Engineers, and the Florida Department of Environmental Protection have
expressed their intention to participate as cooperating agencies in the
preparation of the EIS.
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    \3\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, Part 1501.6.
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Consultations Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, we are using this notice to initiate consultation
with the Florida State Division of Historical Resources (State Historic
Preservation Office (SHPO)), and to solicit its views and those of
other government agencies, interested Indian tribes, and the public on
the Project's potential effects on historic properties.\4\ We will
define the project-specific Area of Potential Effects (APE) in
consultation with the SHPO as the Project develops. On natural gas
facility projects, the APE at a minimum encompasses all areas subject
to ground disturbance (examples include construction area, contractor
storage yards, and access roads). Our EIS for this Project will
document our findings on the impacts on historic properties and
summarize the status of consultations under section 106.
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    \4\ The Advisory Council on Historic Preservation regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register for Historic
Places.
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Currently Identified Environmental Issues

    We have already identified several issues that we think deserve
attention based on a preliminary review of the planned facilities and
the environmental information provided by Eagle LNG. This preliminary
list of issues may change based on your comments and our continued
analysis. Issued identified include:
     Potential impacts on recreational fishing and aquatic
resources in the vicinity of Bartram Island and along the St Johns
River Shipping Channel;
     potential water quality impact from dredging and disposal;
     visual effects on surrounding areas;
     public safety and hazards associated with the transport of
natural gas and LNG; and
     potential impacts and potential benefits of construction
workforce on local housing, infrastructure, public services, and
economy.

Public Participation

    You can make a difference by providing us with your specific
comments or concerns about the Project. Your comments should focus on
the potential environmental effects, reasonable alternatives, and
measures to avoid or lessen environmental impacts. The more specific
your comments, the more useful they will be. To ensure that your
comments are timely and properly recorded, please send your comments so
that the Commission receives them in Washington, DC on or before April
24, 2015. This is not your only public input opportunity; please refer
to the Environmental Review Process flowchart in Appendix 2.
    For your convenience, there are three methods you can use to submit
your comments to the Commission. In all instances, please reference the
Project docket number (PF15-7-000) with your submission. The Commission
encourages electronic filing of comments and has expert staff available
to assist you at<PHONE_NUMBER> or<EMAIL_ADDRESS>    (1) You can file your comments electronically using the eComment
(http://www.ferc.gov/docs-filing/ecomment.asp) feature located on the
Commission's Web site (www.ferc.gov) under the link to Documents and
Filings (http://www.ferc.gov/docs-filing/docs-filing.asp). This is an
easy method for interested persons to submit brief, text-only comments
on a project;
    (2) You can file your comments electronically using the eFiling
(http://www.ferc.gov/docs-filing/efiling.asp) feature located on the
Commission's Web site (www.ferc.gov) under the link to Documents and
Filings. With eFiling, you can provide comments in a variety of formats
by attaching them as a file with your submission. New eFiling users
must first create an account by clicking on ``eRegister.'' (http://www.ferc.gov/docs-filing/eregistration.asp). You must select the type
of filing you are making. If you are filing a comment on a particular
project, please select ``Comment on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the following address:

Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE., Room 1A, Washington, DC 20426.

Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for Project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on the Project. We will update the environmental mailing list
as the analysis proceeds to ensure that we

send the information related to this environmental review to all
individuals, organizations, and government entities interested in and/
or potentially affected by the planned Project.
    Copies of the completed draft EIS will be sent to the environmental
mailing list for public review and comment. If you would prefer to
receive a paper copy of the document instead of the CD version or would
like to remove your name from the mailing list, please return the
attached Information Request (Appendix 3).

Becoming an Intervenor

    Once Eagle LNG files its application with the Commission, you may
want to become an ``intervenor'' which is an official party to the
Commission's proceeding. Intervenors play a more formal role in the
process and are able to file briefs, appear at hearings, and be heard
by the courts if they choose to appeal the Commission's final ruling.
An intervenor formally participates in the proceeding by filing a
request to intervene. Instructions for becoming an intervenor are in
the ``Document-less Intervention Guide'' under the ``e-filing'' link on
the Commission's Web site. Motions to intervene are more fully
described at http://www.ferc.gov/help/how-to/intervene.asp. Please note
that the Commission will not accept requests for intervenor status at
this time. You must wait until the Commission receives a formal
application for the Project.

Additional Information

    Additional information about the Project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site (www.ferc.gov) using the eLibrary link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number,
excluding the last three digits in the Docket Number field (i.e., PF15-
7). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to http://www.ferc.gov/docs-filing/esubscription.asp.
    Finally, public meetings or site visits will be posted on the
Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

    Dated: March 25, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-07449 Filed 3-31-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 207 (Thursday, October 27, 2022)]
[Notices]
[Pages 65088-65089]
[FR Doc No: 2022-23377]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2016-D-2565]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; 510(k) Third-Party
Review Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by November 28, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0375. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

510(k) Third-Party Review Program

OMB Control Number 0910-0375--Extension

    Section 523 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360m), directs FDA to accredit persons in the private sector
to review certain premarket notifications (510(k)s; see 21 U.S.C.
360(k)). Participation in the 510(k) third-party (3P510k) review
program by accredited persons is entirely voluntary. A third party
wishing to participate will submit a request for accreditation to FDA.
Accredited third-party reviewers have the ability to review a
manufacturer's 510(k) submission for selected devices. After reviewing
a submission, the reviewer will forward a copy of the 510(k)
submission, along with the reviewer's documented review and
recommendation, to FDA. Third-party reviewers should maintain records
of their 510(k) reviews and a copy of the 510(k) for a reasonable
period of time, usually 3 years.
    Respondents to this information collection are businesses or
government, and can be for-profit or not-for-profit organizations.
    The guidance ``510(k) Third-Party Review Program, Guidance for
Industry, Food and Drug Administration Staff and Third Party Review
Organizations'' (March 2020) (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-third-party-review-program) is intended to provide a comprehensive look into FDA's current
thinking regarding the 3P510k review program. This guidance document
also reflects section 523 of the FD&C Act, which directs FDA to issue
guidance on the factors that will be used in determining whether a
class I or class II device type, or subset of such device types, is
eligible for review by an accredited person. The 3P510k review program
is intended to allow review of devices by third-party 510k review
organizations (3PROs) to provide manufacturers of these devices an
alternative review process that allows FDA to best utilize our
resources on higher risk devices.
    In the Federal Register of June 24, 2022 (87 FR 37863), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although four comments were received, they
were not responsive to the four collection of information topics
solicited.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
     Activity; guidance document section          Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses                                                     \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requests for accreditation (initial); Section               1               1               1  24.......................................              24
 VI.
Requests for accreditation (re-recognition);                3               1               3  24.......................................              72
 Section VI.
510(k) reviews conducted by accredited third                9              14             126  40.......................................           5,040
 parties; Section VI.
Complaints; Section VII......................               1               1               1  0.25 (15 minutes)........................               1
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................           5,137
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Totals have been rounded.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                     Average burden
  Activity; guidance document      Number of       records per    Total annual         per          Total hours
            section              recordkeepers    recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
510(k) reviews; Section VII...                9              14             126               10           1,260
Records regarding                             9               1               9                1               9
 qualifications to receive FDA
 recognition as a 3PRO;
 Section VII..................
Recordkeeping system regarding                9               1               9                2              18
 complaints; Section VII......
                               ---------------------------------------------------------------------------------

    Total.....................  ...............  ..............  ..............  ...............           1,287
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

Estimated Annual Recordkeeping Burden

    510(k) reviews: The 3PROs should retain copies of all 510(k)
reviews and associated correspondence. Based on FDA's recent experience
with this program, we estimate the number of 510(k)s submitted for
3P510k review to be 126 annually; approximately 14 annual reviews for
each of the 9 3PROs. We estimate the average burden per recordkeeping
to be 10 hours.
    Records regarding qualifications to receive FDA recognition as a
3PRO: Under section 704(f) of the FD&C Act (21 U.S.C. 374(f)), a 3PRO
must maintain records that support their initial and continuing
qualifications to receive FDA recognition, including documentation of
the training and qualifications of the 3PRO and its personnel; the
procedures used by the 3P510k review organization for handling
confidential information; the compensation arrangements made by the
3PRO; and the procedures used by the 3PRO to identify and avoid
conflicts of interest. Additionally, the guidance states that 3PROs
should retain information on the identity and qualifications of all
personnel who contributed to the technical review of each 510(k)
submission and other relevant records. Because most of the burden of
compiling the records is expressed in the reporting burden for requests
for accreditation, we estimate the maintenance of such records to be 1
hour per recordkeeping annually.
    Recordkeeping system regarding complaints: Section 523(b)(3)(F)(iv)
of the FD&C Act requires 3PROs to agree in writing that they will
promptly respond and attempt to resolve complaints regarding their
activities. The guidance recommends that 3PROs establish a
recordkeeping system for tracking the submission of those complaints
and how those complaints were resolved, or attempted to be resolved.
Based on our experience with the program and the recommendations in the
guidance, we estimate the average burden per recordkeeping to be 2
hours annually.
    Based on our experience with the program since our last request for
OMB approval, we have adjusted our burden estimate, which has resulted
in a decrease to the currently approved burden.

    Dated: October 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23377 Filed 10-26-22; 8:45 am]
BILLING CODE 4164-01-P


DRAFT MEMORANDUM

TO:	  SEQ CHAPTER \h \r 1 Public Record for the Effluent Limitations
Guidelines and Standards for the Construction and Development Industry

FROM:	Tetra Tech, Inc.

DATE:	11 November 2008

SUBJECT:	Electronic File Documentation

Overview

The purpose of this memorandum is to document electronic files used in
modeling effects of effluent limitations guidelines (ELG) for the
Construction and Development (C&D) industry.  The archived files are in
spatial (vector and raster/grid), spreadsheet (Excel file), and database
(MS Access) formats.  Table 1 documents spatial data used in the
analysis, and Table 2 presents a list of data summaries in an MS Access
database. More extensive descriptions of the electronic data structures
and their roles in the analysis follow the tables.

Table   SEQ Table \* ARABIC  1 . Summary of spatial data files

Data Type	Spatial Data Files in Archive

Background

	States vector file	Urban Areas vector file

Erosivity

	R Factor grid

Land Cover Change

	USGS ERF1 -- Enhanced River Reach File 1.2 vector file

	Area NLCD 1992-2001 Land-cover Change Estimates by ERF1.2 (dbf file)
Percent NLCD 1992-2001 Land-cover Change Estimates by ERF1.2 (dbf file)

Precipitation

	PRISM United States Average Monthly or Annual Precipitation, 1971 –
2000 grid

Soils/Soil Fractions	USDA State Soil Geographic Database (STATSGO)
Mapping Units vector file

Table 2. List of database tables summarizing data derived from analyses

Table	Description

Annual urban ppt inches	Urban area average annual precipitation

Dev_ppt	ERF1.2 30 year average annual precipitation (inches and change
in developed acreage (1992-2001)

Erf12_area	Area (sq m) of ERF1.2 watershed NLCD change 1992-2001

Erf12_pct	Percent of ERF1.2 watershed NLCD change 1992-2001

Hyd Group by State	State HYD group from STATSGO

Kfactor	ERF1.2 K Factor from STATSGO

PPT_monthly_percent_State	PRISM monthly precipitation averages by state

Rvalue	ERF1.2 R value

Slopes	ERF1.2 Slope from STATSGO

St_rf1_USA	State and ERF1.2 intersections with area

Wted_Soil_Fraction_RF1ST	STATSGO soil fractions per state/ERF1.2 polygon

Data Descriptions

Spatial files

The following spatial files are intended to provide general background
layers for mapping the subsequent spatial data sets.

States

The States.shp was taken from the 2002 Environmental Systems Research
Institute, Inc. (ESRI) data disk ESRI Data & Maps 2002 (CD 3).  The
basic file is used for representing the fifty states and the District of
Columbia of the United States at a 1:100,000 scale.

Urban Areas

The UrbanAreas.shp was taken from the U.S. National Atlas Urbanized
Areas file from ESRI data disk ESRI Data & Maps 2002 (CD 2).  At a
1:1,500,000 scale, the U.S. National Atlas Urbanized Areas file
represents urban areas in the United States derived from the urban areas
layer of the Digital Chart of the World.

Erosivity (R Factor)

Erosivity describes the potential for soil to wash off disturbed,
denuded earth into waterways during storms.  Using a computer model
supported by soil and rainfall data, U.S. Department of Agriculture
(USDA) established estimates of annual erosivity values (R) for sites
throughout the country. These R factors are used as surrogate measures
of the impact that rainfall has on erosion from a particular site. The
1-kilometer raster grid ArcInfo grid rmap was derived in 2008 from the
LEW tool on the Tetra Tech NPDES website.

Land Cover Change (ERF1 -- Enhanced River Reach File 1.2)

The Enhanced River Reach File 1.2 (ERF1.2) Watersheds were released by
USGS in November 2003.  The digital segmented network based on watershed
boundaries, ERF1.2, includes enhancements to the U.S. Environmental
Protection Agency's River Reach File 1 (RF1) (USEPA 1996; DeWald and
others 1985) to support national and regional-scale surface
water-quality modeling.  ERF1.2 serves as the foundation for SPARROW
(Spatially Referenced Regressions (of nutrient transport) on Watershed)
modeling.  This version of the network expands on ERF1 (Version 1.2;
Alexander et al. 1999) and includes the incremental and total drainage
area derived from 1-kilometer (km) elevation data for North America.  A
1-kilometer raster grid of ERF1.2 was merged with the HYDRO1K flow
direction data set to generate a DEM-based watershed grid.  This grid
was used to summarize land use change and analyze development rates
across the country for the Construction and Development Effluent
Limitation Guideline.

Area NLCD 1992-2001 Land-cover Change Estimates by ERF1.2

Percent NLCD 1992-2001 Land-cover Change Estimates by ERF1.2

Wickham and Wade (EPA/ORD/NERL/ESD/LEB) processed area and percent of
urban land cover change in February 2008 to create NLCD 1992-2001
Percent Land-cover Change Estimates by ERF1.2.  The land cover change
estimates were derived from the NLCD 1992/2001 Retrofit Land Cover
Change Product on an ERF1.2 level for the contiguous United States.
Percent of land cover changing between the two time periods (1992 and
2001) in an ERF watershed is presented and can be joined to a spatial
file (ERF12_Watershed GRID_CODE).  The ERF1.2 watershed summarization of
developed land cover change provides a basis for estimation of national
development rates for the C&D ELG.

Precipitation (United States Average Monthly or Annual Precipitation,
1971 – 2000)

The PRISM Group at Oregon State University created the precipitation
data set that contains spatially gridded average monthly and annual
precipitation for the climatological period 1971-2000. Distribution of
the point measurements to a spatial grid was accomplished using the
PRISM (Parameter-elevation Regressions on Independent Slopes Model)
model, developed and applied by Chris Daly of OSU PRISM Group.  PRISM is
an analytical model that uses point data and an underlying grid such as
a digital elevation model (DEM) or a 30 yr climatological average (e.g.
1971- 2000 average) to generate gridded estimates of monthly and annual
precipitation and temperature (as well as other climatic parameters).
Grids were modeled on a monthly basis and annual grids of temperature
were produced by averaging the monthly grids, and summing for
precipitation.

Soils (USDA State Soil Geographic Database (STATSGO) Mapping Units)

This dataset contains files specifying the 10,500 map units defined for
the 48 conterminous states for the STATSGO soils data compiled by the
Natural Resources Conservation Service (NRCS) of the USDA.  This
database was created by generalizing soil-survey maps, including
published and unpublished detailed soil surveys, county general soil
maps, state general soil maps, state major land resource area maps, and,
where no soil survey information was available, Landsat imagery.
Because climate and hydrology models require information about soil
physical properties in the form of continuous distributions rather than
discrete classes, soil fractions were derived for the 11 standard layers
for each map unit using the STATSGO Component and Layer tables.  In the
case of soil texture, the relative proportions of sand, silt, and clay
provide an alternative to discrete texture classes

Database files

The MS Access database (DEVT_Summary_DB.mdb) contains tables summarizing
results of major data processing efforts.

Development data are presented in Dev_ppt, Erf12_area, and Erf12_pct
tables.  Precipitation data are included in Annual_urban_ppt_inches,
Dev_ppt, and PPT_monthly_percent_State.  Hyd Group by State, Kfactor,
Rvalue, Slopes, and Wted_Soil_Fraction_RF1ST summarize data for states
or watersheds derived from STATSGO.  St_rf1_USA refers to a boundary
intersection of states and ERF1.2 watersheds and is used for scaling
watershed level data up to the state level, or vice versa.

Annual urban ppt inches

Annual precipitation (inches) averages derived from the PRISM Group at
Oregon State University data are provided for 6054 urban areas in the
contiguous United States.

Dev_ppt

ERF1.2 watershed estimates of area in square meters and acres in 2001
and 1992 in urban land cover are presented in this table.  Average
annual precipitation (inches) is also given for each watershed.

Erf12_area and Erf12_pct

These tables provide the raw output of the Wickham and Wade
(EPA/ORD/NERL/ESD/LEB) February 2008 analysis showing area and percent
of urban land cover change between 1992 and 2001 NLCD.  Included are
areas for land cover categories of forest, wetland, shrub, agriculture,
barren, and water.

Hyd Group by State

For each state in the contiguous United States, this table presents the
amount of land that falls into the hydrologic groups A, B, C, D, and W
(water).  Hydrology Class A soils have high infiltration rates.
Hydrology Class B soils have moderate infiltration rates. Hydrology
Class C soils have slow infiltration rates. Hydrology Class D soils have
very slow infiltration rates.

K-factor

The K factor was summarized for every ERF1.2 watershed based on STATSGO
K fact and K ffact parameters. The K factor is the soil erodibility
factor that represents both susceptibility of soil to erosion and the
rate of runoff.

PPT_monthly_percent_State

This table shows percent of annual precipitation for each month of the
year, derived from on 1971–2000 averages from the PRISM Group at
Oregon State University data.  State estimates were based on the monthly
precipitation proportions in each state’s urban areas.

R-value

The minimum, maximum, and average R values for the rainfall-runoff
erosivity factor from STATSGO is provided for each ERF1.2 watershed.

Slopes

Minimum and maximum slope values from STATSGO are provided for each
ERF1.2 watershed.

St_rf1_USA

This table provides areas of watersheds that span state boundaries and
can be used to scale data from a watershed basis to a state estimate.

Wted_Soil_Fraction_RF1ST

Percent silt, percent sand, and percent clay values derived from STATSGO
are provided for each ERF1.2 watershed.

Other files

Clay_fraction_StateEst.xls was a preliminary file meant for exploration
of percent acreages per state and watershed that fell within given
percent clay ranges.  The weighted soil fraction table results in the MS
Access database now present this data in another form.

Top10URBAN.xls reflects the methods used for selection of indicator city
per EPA region.  Percent urban change and amount of urban acreage change
were calculated for urban areas in each region and then ranked to
support selection of indicator cities.

STATSGO_Tables.mdb is a MS Access database of original STATSGO data
tables that were used to derive results using the ERF1.2 watershed,
urban area, and state boundary files.


[Federal Register Volume 84, Number 129 (Friday, July 5, 2019)]
[Notices]
[Pages 32194-32196]
[FR Doc No: 2019-14329]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2019-0002; Internal Agency Docket No. FEMA-B-1933]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report, once effective, will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings.

DATES: Comments are to be submitted on or before October 3, 2019.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location https://www.fema.gov/preliminaryfloodhazarddata and the
respective Community Map Repository address listed in the tables below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1933, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard

determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and are used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location
https://www.fema.gov/preliminaryfloodhazarddata and the respective
Community Map Repository address listed in the tables. For communities
with multiple ongoing Preliminary studies, the studies can be
identified by the unique project number and Preliminary FIRM date
listed in the tables. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at https://msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
              Buchanan County, Iowa and Incorporated Areas
        Project: 17-07-0295S Preliminary Date: December 10, 2018
------------------------------------------------------------------------
City of Aurora.........................  City Office, 331 Main Street,
                                          Aurora, IA 50607.
City of Brandon........................  City Hall, 400 North Street,
                                          Brandon, IA 52210.
City of Fairbank.......................  City Hall, 116 East Main
                                          Street, Fairbank, IA 50629.
City of Hazleton.......................  City Hall, 111 3rd Street
                                          North, Hazleton, IA 50641.
City of Independence...................  City Hall, 331 1st Street East,
                                          Independence, IA 50644.
City of Jesup..........................  City Hall, 791 6th Street,
                                          Jesup, IA 50648.
City of Lamont.........................  City Hall, 644 Bush Street,
                                          Lamont, IA 50650.
City of Quasqueton.....................  City Hall, 113 Water Street
                                          North, Quasqueton, IA 52326.
City of Stanley........................  Mayor's Office, 128 East Main
                                          Street, Stanley, IA 50671.
City of Winthrop.......................  City Clerk's Office, 354
                                          Madison Street, Winthrop, IA
                                          50682.
Unincorporated Areas of Buchanan County  Buchanan County Courthouse
                                          Zoning Office, 210 5th Avenue
                                          Northeast, Suite I,
                                          Independence, IA 50644.
------------------------------------------------------------------------
               Butler County, Iowa and Incorporated Areas
        Project: 17-07-0295S Preliminary Date: November 15, 2018
------------------------------------------------------------------------
City of Allison........................  City Hall, 410 North Main
                                          Street, Allison, IA 50602.
City of Aplington......................  City Hall, 409 10th Street,
                                          Aplington, IA 50604.
City of Aredale........................  City Hall, 102 East Main
                                          Street, Aredale, IA 50605.
City of Bristow........................  City Hall, 716-A West Street,
                                          Bristow, IA 50611.
City of Clarksville....................  City Hall, Maintenance, 115
                                          West Superior Street,
                                          Clarksville, IA 50619.
City of Dumont.........................  City Hall, 625 1st Street,
                                          Dumont, IA 50625.
City of Greene.........................  City Hall, 202 West South
                                          Street, Greene, IA 50636.
City of New Hartford...................  City Hall, 503 Packwaukee
                                          Street, New Hartford, IA
                                          50660.
City of Parkersburg....................  City Hall, 608 Highway 57,
                                          Parkersburg, IA 50665.
City of Shell Rock.....................  City Hall, 802 North Public
                                          Road, Shell Rock, IA 50670.
Unincorporated Areas of Butler County..  Butler County Courthouse
                                          Engineering Department, 428
                                          6th Street, Allison, IA 50602.
------------------------------------------------------------------------
              Muscatine County, Iowa and Incorporated Areas
         Project: 16-07-2337S Preliminary Date: August 29, 2018
------------------------------------------------------------------------
City of Atalissa.......................  City Hall, 122 3rd Street,
                                          Atalissa, IA 52720.
City of Muscatine......................  City Hall, 215 Sycamore Street,
                                          Muscatine, IA 52761.
City of Nichols........................  City Hall, 429 Ijem Avenue,
                                          Nichols, IA 52766.
City of Stockton.......................  City Hall, 318 Commerce Street,
                                          Stockton, IA 52769.
City of West Liberty...................  City Hall, 409 North Calhoun
                                          Street, West Liberty, IA
                                          52776.
City of Wilton.........................  City Hall, 104 East 4th Street,
                                          Wilton, IA 52778.

Unincorporated Areas of Muscatine        Muscatine County Building, 3610
 County.                                  Park Avenue West, Muscatine,
                                          IA 52761.
------------------------------------------------------------------------
             St. Clair County, Michigan (All Jurisdictions)
        Project: 13-05-1848S Preliminary Date: December 14, 2018
------------------------------------------------------------------------
Township of Clay.......................  Township Municipal Building,
                                          4710 Pointe Tremble Road,
                                          Algonac, MI 48001.
Township of Cottrellville..............  Township Hall, 7008 Marsh Road,
                                          Cottrellville, MI 48039.
Township of Ira........................  Township Hall, 7085 Meldrum
                                          Road, Fair Haven, MI 48023.
------------------------------------------------------------------------

[FR Doc. 2019-14329 Filed 7-3-19; 8:45 am]
 BILLING CODE 9110-12-P


[Federal Register: August 5, 2010 (Volume 75, Number 150)]
[Notices]
[Page 47303-47304]
[DOCID:fr05au10-72]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2010-0340; FRL-9185-3; EPA ICR Number 1984.04; OMB Control
Number 2060-0552]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for Plywood and Composite
Products (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before September 7,
2010.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2010-0340 to (1) EPA online using http://www.regulations.gov (our
preferred method), or by e-mail to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
28221T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, and (2)
OMB at: Office of Information and Regulatory Affairs, Office of
Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th
Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Compliance Assessment
and Media Programs Division, Office of Compliance, Mail Code 2223A,
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On June 2, 2010 (75 FR 30813), EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional
comments on this ICR should be submitted to EPA and OMB within 30 days
of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2010-0340, which is available for public viewing
online at http://www.regulations.gov, in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC),
EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Reading Room is<PHONE_NUMBER>, and the telephone number
for the Enforcement and Compliance Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov, as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://
www.regulations.gov.
    Title: NESHAP for Plywood and Composite Products (Renewal).
    ICR Numbers: EPA ICR Number 1984.04, OMB Control Number 2060-0552.
    ICR Status: This ICR is schedule to expire on October 31, 2010.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
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. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, and displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) for Plywood and Composite Products were proposed on
January 9, 2003, and promulgated on July 30, 2004, and amended on
February 16, 2006.
    This regulation covers both new and existing plywood and composite
wood products (PCWP) facilities. Plywood and/or composite products are
manufactured by bonding wood material (fibers, particles, strands,
veneers, etc.) or agricultural fiber with resin, generally under head
and pressure, to form a structural panel or engineered wood product.
Plywood and composite products include, but are not limited to,
plywood, veneer, particleboard, oriented strand board, hardboard,
fiberboard, medium density fiberboard, laminated strand lumber,
laminated veneer lumber, wood I-joists, kiln-dried lumber and glue-
laminated beams.
    Owners/operators of plywood and composite products facilities are
required to submit initial notification, performance tests, and
compliance status reports. Also, respondents are required to maintain
records of the occurrence and duration of any startup, shutdown, or
malfunction in the operation of an affected facility, or any period
during which the monitoring system is inoperative. Semiannual reports
are required. These notifications, reports, and records are essential
in determining compliance and, in general, are required of all sources
subject to NESHAP.
    Any owner or operator subject to the provisions of this part shall
maintain a file of these measurements, and retain the file for at least
five years following the date of such measurements, maintenance
reports, and records. Performance tests reports are required as this is
the Agency's record of a source's initial capability to comply with the
emission standard, and they serve as a record of the operating
conditions under which compliance was achieved.
    All reports are sent to the delegated State or local authority. In
the event that there is no such delegated authority, the reports are
sent directly to the EPA regional office. This information is

being collected to assure compliance with 40 CFR part 63, subpart DDDD,
as authorized in section 112 and 114(a) of the Clean Air Act. The
required information consists of emissions data and other information
that has been determined to be private.
    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. The OMB Control Number for EPA's
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are
identified on the form and/or instrument, if applicable.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 21
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purpose of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information. All
existing ways will have to adjust to comply with any previously
applicable instructions and requirements that have subsequently
changed; train personnel to be able to respond to a collection of
information; search data sources; complete and review the collection of
information; and transmit or otherwise disclose the information.
    Respondents/Affected Entities: Plywood and composite products.
    Estimated Number of Respondents: 228.
    Frequency of Response: Initially and semiannually.
    Estimated Total Annual Hour Burden: 11,680.
    Estimated Total Annual Cost: $1,120,813 which includes $1,104,853
in labor costs, no capital/startup costs, and $15,960 in operation and
maintenance (O&M) costs.
    Changes in the Estimates: There is an adjustment in the labor hour
burden in this ICR compared to the previous ICR. The labor burden is
decreased compared to the most recently approved ICR because the
industry is experiencing a flat production with no new facilities
anticipated in the three years of this ICR. In addition, the new
facilities in the previous ICR have become existing facilities.
Existing facilities must demonstrate and report continuing compliance
with the requirement.
    There is a decrease in the capital/startup and O&M costs compared
to the previous ICR because there are no new facilities that must
purchase continuous monitoring equipment.

    Dated: July 30, 2010.
John Moses,
Director, Collection Strategies Division.
[FR Doc. 2010-19281 Filed 8-4-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 206 (Thursday, October 26, 2017)]
[Notices]
[Page 49604]
[FR Doc No: 2017-23283]

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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 Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP17-1103-001.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Tariff Amendment: Virginia Southside Expansion Project
II Initial Rates Amended to be effective 12/1/2017.
    Filed Date: 10/17/17.
    Accession Number: 20171017-5178.
    Comments Due: 5 p.m. ET 10/30/17.

    Docket Numbers: RP18-37-000.
    Applicants: Equitrans, L.P.
    Description: Compliance filing Notice Regarding Non-Jurisdictional
Gathering Facilities (F-1006 F-1008 F-1009).
    Filed Date: 10/17/17.
    Accession Number: 20171017-5127.
    Comments Due: 5 p.m. ET 10/30/17.

    Docket Numbers: RP18-38-000.
    Applicants: Great Lakes Gas Transmission Limited Partnership.
    Description: Sec.  4(d) Rate Filing: Language Revision and Updates
to be effective 11/18/2017.
    Filed Date: 10/17/17.
    Accession Number: 20171017-5139.
    Comments Due: 5 p.m. ET 10/30/17.

    Docket Numbers: RP18-39-000.
    Applicants: Natural Gas Pipeline Company of America LLC.
    Description: Sec.  4(d) Rate Filing: Shell Energy North America-NRA
Filing to be effective 10/18/2017.
    Filed Date: 10/17/17.
    Accession Number: 20171017-5163.
    Comments Due: 5 p.m. ET 10/30/17.

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

    Dated: October 18, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-23283 Filed 10-25-17; 8:45 am]
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[Federal Register: April 11, 2006 (Volume 71, Number 69)]
[Notices]
[Page 18302-18303]
[DOCID:fr11ap06-60]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[IC06-716-001, FERC-716]

Commission Information Collection Activities, Proposed
Collection; Comment Request; Extension

April 5, 2006.
AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice.

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SUMMARY: In compliance with the requirements of section 3507 of the
Paperwork Reduction Act of 1995, 44 U.S.C. 3507, the Federal Energy
Regulatory Commission (Commission) has submitted the information
collection described below to the Office of Management and Budget (OMB)
for review and extension of this information collection requirement.
Any interested person may file comments directly with OMB and should
address a copy of those comments to the Commission as explained below.
The Commission received no comments in response to an earlier Federal
Register notice of January 19, 2005 (71 FR 3064-3065) and has made this
notation in its submission to OMB.

DATES: Comments on the collection of information are due by May 18,
2006.

ADDRESSES: Address comments on the collection of information to the
Office of Management and Budget, Office of Information and Regulatory
Affairs, Attention: Federal Energy Regulatory Commission Desk Officer.
Comments to

OMB should be filed electronically, c/o<EMAIL_ADDRESS>and include the OMB Control No. as a point of reference. The Desk
Officer may be reached by telephone at<PHONE_NUMBER>. A copy of the
comments should also be sent to the Federal Energy Regulatory
Commission, Office of the Executive Director, ED-34; Attention: Michael
Miller, 888 First Street, NE., Washington, DC 20426. Comments may be
filed either in paper format or electronically. Those persons filing
electronically do not need to make a paper filing. For paper filings,
the original and 14 copies of such comments should be submitted to the
Secretary of the Commission, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426 and should refer to Docket No.
IC06-716-001.
    Documents filed electronically via the Internet must be prepared in
WordPerfect, MS Word, Portable Document Format, or ASCII format. To
file the document, access the Commission's website at http://www.ferc.gov
 and click on ``Make an E-Filing,'' and then follow the

instructions for each screen. First time users will have to establish a
user name and password. The Commission will send an automatic
acknowledgement to the sender's e-mail address upon receipt of
comments. User assistance for electronic filings is available at 202-
502-8258 or by e-mail to<EMAIL_ADDRESS>Comments should not be
submitted to this e-mail address.
    All comments may be viewed, printed or downloaded remotely via the
Internet through FERC's homepage using the ``eLibrary'' link. Enter the
docket number excluding the last three digits in the docket number
field to access the document. For user assistance, contact
<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>. or for TTY,

contact<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Michael Miller may be reached by
telephone at<PHONE_NUMBER>, by fax at<PHONE_NUMBER>, and by e-mail at
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

Description

    The information collection submitted for OMB review contains the
following:
    1. Collection of Information: FERC-716 ``Good Faith Request for
Transmission Service and Response by Transmitting Utility under
sections 211(a) & 213(a) of the FPA'' .
    2. Sponsor: Federal Energy Regulatory Commission.
    3. Control No.: 1902-0170.
    The Commission is now requesting that OMB approve and extend the
expiration date for an additional three years with no changes to the
existing collection. The information is not filed with the Commission
but is used in conjunction with FERC-716A which is mandatory.
    4. Necessity of the Collection of Information: Submission of the
information is necessary for the Commission to carry out its
responsibilities in implementing the statutory provisions of sections
211 and 213 of the Federal Power Act (FPA) as amended and added by the
Energy Policy Act of 1992. The information is not filed with the
Commission, however, the request and response may be analyzed as a part
of a section 211 proceeding. This collection of information covers the
information that must be contained in the request and in the response.
    The Energy Policy Act of 1992 amended section 211 of the FPA and
expanded the Commission's authority to order transmission service.
Under the revised section 211, the Commission may order transmission
services if it finds that such action would be in the public interest,
would not unreasonably impair the continued reliability of electric
systems affected by the order, and would, meet the requirements of
amended section 211 of the FPA.
    The Commission's policy statement in Public Law 93-3, Policy
Statement Regarding Good Faith Requests for Transmission Services and
Responses by Transmitting Utilities under sections 211(a) and 213(a) of
the Federal Power Act, as amended, implemented a data exchange between
a transmission requester and a transmitting utility prior to the
submission of a section 211 request with the Commission. Components of
the data exchange are identified in the Code of Federal Regulations
(CFR), 18 CFR 2.20. The general policy sets forth standards by which
the Commission determines whether and when a valid good faith request
for transmission has been made under section 211 of the FPA. In
developing the standards, the Commission sought to encourage an open
exchange of information with a reasonable degree of specificity and
completeness between the party requesting transmission services and the
transmitting utility. As a result, twelve components of a good faith
estimate are identified under 18 CFR 2.20.
    5. Respondent Description: The respondent universe currently
comprises 8 companies (on average) subject to the Commission's
jurisdiction.
    6. Estimated Burden: 800 total hours, 8 respondents (average), 1
response per respondent, and 100 hours per response (average).
    7. Estimated Cost Burden to respondents: 800 hours/2080 hours per
years x $112,767 per year = $43,372. The cost per respondent is equal
to $5,421.

    Statutory Authority: Sections 211 and 213 of the Federal Power
Act as amended and added by the Energy Policy Act 1992.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-5320 Filed 4-10-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 125 (Wednesday, June 29, 2016)]
[Notices]
[Pages 42350-42351]
[FR Doc No: 2016-15408]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9948-52-Region 6]

Adequacy Status of the Baton Rouge, Louisiana Maintenance Plan 8-
Hour Ozone Motor Vehicle Emission Budgets for Transportation Conformity
Purposes

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of adequacy.

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SUMMARY: The Environmental Protection Agency (EPA) is notifying the
public that it has found that the motor vehicle emissions budgets
(MVEBs) in the Baton Rouge, Louisiana 2008 8-hour Ozone National
Ambient Air Quality Standard (NAAQS) Maintenance Plan State
Implementation Plan (SIP) revision, submitted on May 2, 2016 by the
Louisiana Department of Environmental Quality (LDEQ) are adequate for
transportation conformity purposes. As a result of EPA's finding, the
Baton Rouge area must use these budgets for future conformity
determinations.

DATES: These budgets are effective July 14, 2016.

FOR FURTHER INFORMATION CONTACT: The essential information in this
notice will be available at EPA's conformity Web site: http://www.epa.gov/otaq/stateresources/transconf/adequacy.htm. You may also
contact Mr. Jeffrey Riley, Air Planning Section (6MM-AA), U.S.
Environmental Protection Agency, Region 6, 1445 Ross Avenue, Dallas,
Texas 75202-2733, telephone<PHONE_NUMBER>, Email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refers to EPA. The word ``budget(s)'' refers to the mobile
source emissions budget for volatile organic compounds (VOCs) and the
mobile source emissions budget for nitrogen oxides (NOX).
    On May 2, 2016, we received a SIP revision from the LDEQ. This
revision consisted of a 2008 8-hour ozone NAAQS redesignation request
and maintenance plan SIP for the Baton Rouge area. This submission
established MVEBs for the Baton Rouge area for the years 2022 and 2027.
The MVEB is the amount of emissions allowed in the state implementation
plan for on-road motor vehicles; it establishes an emissions ceiling
for the regional transportation network. The MVEBs are provided in
Table 1:

         Table 1--Baton Rouge Maintenance Plan NOX and VOC MVEBS
                      [Summer season tons per day]
------------------------------------------------------------------------
                                                    2022         2027
------------------------------------------------------------------------
NOX...........................................        14.37        10.95
VOC...........................................        13.19        11.55
------------------------------------------------------------------------

    On May 6, 2016, EPA posted the availability of the Baton Rouge area
MVEBs on EPA's Web site for the purpose of soliciting public comments,
as part of the adequacy process pursuant to 40 CFR 93.118(e)(4). The
comment period closed on June 6, 2016, and we received no comments.
    Today's notice is simply an announcement of a finding that EPA has
already made. EPA Region 6 sent a letter to LDEQ on June 13, 2016,
finding that the MVEBs in the Baton Rouge Maintenance Plan SIP,
submitted on May 2, 2016 are adequate and must be used for
transportation conformity determinations in the Baton Rouge area. This
finding has also been announced on EPA's conformity Web site: http://www.epa.gov/otaq/stateresources/transconf/adequacy.htm.
    Transportation conformity is required by section 176(c) of the
Clean Air Act. EPA's conformity rule, 40 Code of

Federal Regulations (CFR) part 93, requires that transportation plans,
programs and projects conform to state air quality implementation plans
and establishes the criteria and procedures for determining whether or
not they do so. Conformity to a SIP means that transportation
activities will not produce new air quality violations, worsen existing
violations, or delay timely attainment of the national ambient air
quality standards.
    The criteria by which EPA determines whether a SIP's MVEB is
adequate for transportation conformity purposes are outlined in 40 CFR
93.118(e)(4). We have also described the process for determining the
adequacy of submitted SIP budgets in our July 1, 2004, final rulemaking
entitled, ``Transportation Conformity Rule Amendments for the New 8-
hour Ozone and PM2.5 National Ambient Air Quality Standards
and Miscellaneous Revisions for Existing Areas; Transportation
Conformity Rule Amendments: Response to Court Decision and Additional
Rule Changes'' (69 FR 40004). Please note that an adequacy review is
separate from EPA's completeness review, and it should not be used to
prejudge EPA's ultimate approval of the Baton Rouge Maintenance Plan
SIP revision submittal. Even if EPA finds the budgets adequate, the
Baton Rouge Maintenance Plan SIP revision submittal could later be
disapproved.
    These new MVEBs are effective July 14, 2016. Within 24 months from
the effective date of this notice, the Baton Rouge area transportation
partners, such as the Capital Region Planning Commission, will need to
demonstrate conformity to the new MVEBs if the demonstration has not
already been made, pursuant to 40 CFR 93.104(e). See 73 FR 4419
(January 24, 2008).

    Authority: 42 U.S.C. 7401 et seq.

    Dated: June 17, 2016.
Ron Curry,
Regional Administrator, Region 6.
[FR Doc. 2016-15408 Filed 6-28-16; 8:45 am]
BILLING CODE 6560-50-P