[Federal Register Volume 76, Number 121 (Thursday, June 23, 2011)]
[Notices]
[Pages 36919-36922]
[FR Doc No: 2011-15642]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2009-0274; FRL-9322-8]
[RIN 2020-AA47]

Proof of Concept Demonstration for Electronic Reporting of Clean
Water Act Compliance Monitoring Data: Announcement of Meeting and
Demonstration

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) will conduct a
public webinar in order to inform interested parties about an
opportunity to participate in a technical proof of concept
demonstration for electronic reporting of Clean Water Act (CWA)
National Pollutant Discharge Elimination System (NPDES) Discharge
Monitoring Report (DMR) compliance monitoring data. This webinar will
be held on Wednesday, July 13, 2011, from 10:30 a.m.-12 p.m. EDT.
    EPA announced on July 6, 2009, that it would develop a Clean Water
Action Plan \1\ to enhance public transparency regarding clean water
enforcement performance at Federal and state levels, to strengthen that
performance, and to transform EPA's water quality and compliance
information systems. A consensus suggestion across co-regulators and
stakeholder groups was

to implement electronic reporting from facilities that are required to
submit reports to a regulatory agency. To fully realize the
transformation of reporting and data management into the 21st century,
OECA is developing a rule to require NPDES permittees to provide a
variety of environmental information electronically. EPA is exploring
different electronic reporting options to enable NPDES regulated
facilities to electronically submit their compliance monitoring data.
EPA will conduct a technical proof of concept to demonstrate the
electronic reporting of NPDES compliance monitoring data from regulated
facilities via an `open platform e-file' electronic reporting option.
The `open platform e-file' proof of concept demonstration will focus
the electronic transmission of NPDES DMRs from a third-party commercial
software provider (``provider'') to EPA. If EPA were to fully implement
this option, any provider that meets the Agency's data exchange
standards, protocols, and specifications would be able to offer
electronic reporting services to the regulated community for the NPDES
program (e.g., NPDES permitted facilities). This open platform model
would likely be similar to the Internal Revenue Service (IRS) model for
electronic reporting, which uses third-party software providers for tax
data collection and transmission (e.g., TurboTax, TaxACT, or others [no
endorsement intended or implied]) from private citizens and businesses.
The Agency does not intend to purchase services from any provider. All
financial transactions would be between the providers and members of
the regulated community. EPA will conduct a public webinar to provide
an overview of the ``open platform e-file option'' and to identify
person(s) interested in participating in a proof of concept
demonstration of the technical feasibility of this ``open platform e-
file option'' and to identify the specific system and process
information necessary for this proof of concept demonstration.
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    \1\ See: http://www.epa.gov/oecaerth/civil/cwa/cwaenfplan.html.

DATES: EPA will conduct the public webinar on Wednesday, July 13, 2011,
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from 10:30 a.m.-12 p.m. EDT.

ADDRESSES: Persons interested in attending this webinar should register
at: https://www1.gotomeeting.com/register/887495337.

FOR FURTHER INFORMATION CONTACT: For additional information, please
contact Ms. Lucy Reed, Deputy Director, Enforcement Targeting and Data
Division, Office of Compliance (mail code 2222A), Environmental
Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA's information about point source water
pollution and their compliance with the CWA is largely built on paper-
based reporting systems developed nearly forty years ago and initially
focused on a subset of point source pollution. Since then, the universe
of permitted facilities has grown exponentially and there is
significant interest in the electronic reporting of information for
this expanded universe of regulated facilities. Electronic data
collection and transmission could potentially: (1) Aid regulated
facilities in reporting their NPDES compliance monitoring data; (2)
reduce burden on states as electronic data submissions eliminate the
need for transferring data from paper-based forms to databases; (3)
provide more timely and accurate data for enforcement targeting and
reporting; (4) increase transparency on regulatory compliance; and (5)
enhance EPA's oversight and states' management of the NPDES program.
EPA and many states already have built electronic reporting tools for
some of the CWA NPDES compliance monitoring information. For example,
in June 2009, EPA built and made publicly available an electronic
reporting tool, Network Discharge Monitoring Report (NetDMR), for the
electronic reporting of Discharge Monitoring Report (DMR) data from the
regulated facilities to EPA.\2\
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    \2\ See: http://www.epa.gov/netdmr/.
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    In the future, EPA would like to supplement existing electronic
reporting options with the `open platform e-file' option, to allow
providers the opportunity of providing electronic reporting services to
their clients (e.g., NPDES permitted facilities). Similar to the IRS
system, the open platform e-file option would rely on third-party
commercial software providers to gather monitoring data via an
application user interface for the NPDES regulated community to report
the data to EPA and state agencies electronically. Currently, this is
only a technical proof of concept demonstration effort, but if and when
EPA was to fully implement the open platform e-file option, EPA would
need to review and determine if the third-party commercial software
meets the standards, protocols and specifications for electronic
reporting, and how these software providers would share this data with
EPA through the Central Data Exchange (CDX) using the Environmental
Information Exchange Network (``Exchange Network'') services. EPA would
also need to coordinate with states to fully implement the open
platform e-file option as EPA has authorized 46 states to manage the
NPDES permit program.\3\ EPA conducted such coordination with the
development and implementation of NetDMR. The Agency does not intend to
purchase services from any provider as part of this technical proof of
concept. If and when EPA was to fully implement the open platform e-
file option all financial transactions would be between the providers
and members of the regulated community. EPA will not be a party to
these transactions.
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    \3\ See: http://cfpub.epa.gov/npdes/statestats.cfm.
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    EPA will use the webinar as means to provide an overview and the
scope and schedule for the `technical proof of concept' for the open
platform e-file option. The webinar is open to all interested persons
but will be mainly focused on providing information to providers that
might be interested in participating in a `technical proof of concept'
for the open platform e-file option. The webinar will also answer
questions for persons interested in participating in the technical
proof of concept demonstration.
    The webinar will provide an overview on the following topics:
     Agency's Clean Water Action Plan, the NPDES Electronic
Reporting Rule, and the potential role for the open platform e-file
option.
     EPA's CDX and Exchange Network Web services that could
support the open platform e-file option.
     Scope of the technical proof of concept for the open
platform e-file option (DMR data).
     Schedule and requirements for third-party providers
interested in participating in the technical proof of concept.
     Solicit questions from the webinar participants on the
technical proof of concept demonstration.
    The technical proof of concept is open to all providers; however,
providers must describe and provide examples of their work experience
and technical experience in the data exchange and the NPDES permit
program. In order to participate in the technical proof of concept
interested third-party providers must submit a letter of interest, not
to exceed 5 pages, to Ms. Reed, see FOR FURTHER INFORMATION CONTACT
section, by Wednesday, July 27, 2011, indicating their interest in
participating in the technical proof of concept demonstration along
with a short description of their company, contact information, and
work experience (including examples) in using the

following standards, protocols, and specifications in order to use EPA
Exchange Network services:
     The Node 2.0 Functional Specifications and Protocols
(http://www.exchangenetwork.net/node/node2.0.htm).
     Integrated Compliance Information System-National
Pollutant Discharge Elimination System (ICIS-NPDES) Flow Configuration
Document, DMR Extensible Markup Language (XML) Schema, ICIS DMR Batch
User Guide, ICIS DMR Data Exchange Template, and ICIS DMR Example XML
Instance Document (http://www.exchangenetwork.net/exchanges/water/icisnpdes.htm).
     Exchange standards that include: Extensible Markup
Language (XML); Simple Object (SOAP) v 1.2; Web Services Description
Language (WSDL) v1.1; Secure Hypertext Transfer Protocol (https) (see
NIST 800-52); WS-Security v 1.0; and Message Transmission Optimization
mechanism (MTOM).
    The description should include the following items to illustrate
the experience the provider has in meeting the requirements identified
above:

--Connect using https.
--Submit files to an EPA Node using the published WSDL.
--Support Trading Partners in Exchange Network data exchanges using
Node 2.0 specifications.
--Generate data in XML format.
--Operate schema validation tools.
--Parse XML files.
--Gather and store Discharge Monitoring Report data from facilities.
--Provide monthly Discharge Monitoring Report data in an electronic
format.
--Transfer files through the CDX node on the Exchange Network.
--Check the submission status with CDX, and download processing results
from CDX.
--Generate monthly DMR data in XML format as required by ICIS.

Interested third-party providers must also include in their letter of
interest a short written statement of their experience and
understanding of the NPDES program and of their experience with
assisting regulated entities or states with completion of DMR
submissions and whether these submissions used the DMR XML schema, and
the use of the technical specification, protocols, and standards in
these data exchanges. Interested third-party providers must also
include in their letter of interest a statement certifying that they
are not on the General Services Administration's Excluded Parties List
System.\4\
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    \4\ See: https://www.epls.gov/.
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    EPA will review these written submissions to identify the providers
that meet EPA's eligibility requirements for participation in the
technical proof of concept. EPA will determine eligibility based on the
providers written submissions of their work experience (including
examples) in using data exchange standards, protocols, and
specifications (see previous three bullets) and the NPDES permit
program (see previous paragraph). Based on these written submissions
EPA will identify and notify all eligible providers that they have been
accepted in the participation in the technical proof of concept. EPA
will use the webinar to outline the process and factors that it will be
used for determining eligibility for participation in the technical
proof of concept.
    EPA will work with these third-party providers to conduct an
initial service test to connect, authenticate, submit and download a
sample document to a service to be provided by EPA. This initial test
will identify the third-party providers that can successfully connect
to and use EPA's data exchange services, using the following standards
and the Node 2.0 functional specification and protocols and the
exchange standards identified above. EPA will assist these software
providers in setting up and conducting this services test and in
identifying the criteria for demonstrating a successful connection and
use of EPA's data exchange services. See Appendix A, ``Technical Proof
of Concept Objective, Scope, Criteria for Success.'' The initial
services test will need to be completed by August 4, 2011. EPA may
grant an extension to this date for good cause and will notify provider
participants of any changes to this date. Those unable to demonstrate
basic connectivity and use of services within this time frame will not
be able to continue their participation in the technical proof of
concept. EPA will send written notification to these providers
identifying whether they demonstrated a successful connection to EPA's
data exchange services. Providers that have not demonstrated a
successful connection and use of EPA services may send an e-mail to Mr.
Roy Chaudet, EPA's Office of Environmental Information, if they wish
EPA to re-consider its decision (chaudet.roy@epa.gov). During the basic
services test period, technical questions can be directed to Mr.
Chaudet or Ms. Alison Kittle, EPA's Office of Enforcement and
Compliance Assurance (kittle.alison@epa.gov).
    Third-party providers that successfully pass the initial services
test will then conduct another test demonstrating the ability for their
application to perform automated electronic submissions of DMR data to
EPA. EPA will not use actual DMR data for this test but will provide
sample data (e.g., pollutant monitoring data, permit limits) to third-
party software providers to use to create and test their DMR
submissions in this technical proof of concept. EPA will also assist
these providers in setting up and conducting this test and in
identifying the criteria for demonstrating a successful transmission of
DMR data to EPA. See Appendix A, ``Technical Proof of Concept
Objective, Scope, Criteria for Success.'' This second test will need to
be completed by September 30, 2011. EPA may grant an extension to this
date for good cause and will notify provider participants of any
changes to this date.
    Given that this is only a technical proof of concept demonstration,
the requirements of the Cross Media Electronic Reporting Rule
(CROMERR), 40 CFR Part 3, will not be included in this proof of
concept.\5\ EPA notes that full implementation of the open platform e-
file option would require compliance with CROMERR and any future
requirements of the NPDES Electronic Reporting Rule.
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    \5\ See: http://www.epa.gov/cromerr/about.html.
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    EPA will use the webinar to solicit names of persons interested in
a technical proof of concept for the open platform e-file option for
the electronic submission of DMRs. However, participation in the
webinar is not a prerequisite for participation in the technical proof
of concept. At the conclusion of the technical proof of concept
demonstration, EPA will provide a summary of results of the proof of
concept demonstration in the docket for the NPDES Electronic Reporting
Rule (see EPA-HQ-OECA-2009-0274) and on the Web page supporting this
demonstration. Participation in this technical proof of concept is
voluntary and EPA will not be providing funds for participation.
Additionally, EPA will not use this technical proof of concept
demonstration or its results to endorse the commercial products or
services of any third-party software providers.

Proof of Concept Demonstration for Electronic Reporting of Clean Water
Act Compliance Monitoring Data: Announcement of Meeting and
Demonstration

    EPA and the Federal government are prohibited from endorsing any
product,

service or enterprise. EPA will also not use participation in the
technical proof of concept as an eligibility factor for participation
in potential future related data exchange projects or with any
potential production deployment of third-party data exchange. Persons
that are interested in participating in the technical proof of concept
but cannot attend the webinar should contact Ms. Reed, see FOR FURTHER
INFORMATION CONTACT section.

    Dated: June 15, 2011.
Lisa C. Lund,
Director, Office of Compliance.
    Dated: June 15, 2011.
Andrew Battin,
Director, Office of Information Collection.

Appendix A: Technical Proof of Concept Objective, Scope, and Criteria
for Success

    Objective: The objective of the technical proof of concept is to
demonstrate that a third party software provider can offer an
interface to the regulated community that can leverage EPA/Exchange
Network services and meet the requirements for electronic reporting
to EPA's Integrated Compliance Information System (ICIS)-NPDES
system.
    Scope: The technical proof of concept shall demonstrate basic
functionality for electronically submitting DMRs using existing EPA
standards, protocols, and specifications. For this technical proof
of concept, the general scope is expected to include:
    Initial Setup. Each software provider selected for participating
in the technical proof of concept demonstration by EPA must apply
for their own Network Authentication Authorization Services (NAAS)
test account by contacting the Central Data Exchange (CDX) Node Help
Desk at<EMAIL_ADDRESS>All software providers must request
the ICIS test user account and data flow configuration information
for transferring data to EPA's ICIS system by contacting Ms. Kittle
(kittle.alison@epa.gov).
    Basic Permit/DMR Information. EPA will provide permit limit data
to the participating software provider for a sample permit in EPA's
ICIS-NPDES system for the provider to be able to use in their
submissions. EPA will provide the algorithms for anticipating DMRs
from the limit data for the software provider to identify and
extract monitoring data when it is due at EPA. This will be done
using the vendor's software and not simply creating an XML file.
    Preparing DMR for Submission. Using the ICIS limits data and
algorithm provided by EPA, the software provider shall extract the
expected DMR data and use it to prepare an XML file based upon the
format as prescribed in EPA's ICIS DMR Batch User Guide, ICIS DMR
Data Exchange Template, and ICIS DMR Example XML Instance Document.
The software provider will be responsible for validating the
resulting sample DMR XML against the DMR XML schema before
compressing the file into a format compatible with WinZip.
    Electronic Submission of Sample DMR. Using the established
connectivity and the standards, protocols, and specifications for
the Exchange Network's data exchange services, the software provider
shall connect, authenticate and invoke services necessary to
electronically submit their sample DMR XML to CDX.
    Processing by CDX. Once the sample DMR XML zipped file is
received by CDX, it must pass simple validation checks against EPA's
DMR XML schema. The software provider will be responsible for
tracking the status of the submission, obtaining the results of the
submission, correcting any errors that will have occurred, and
resubmitting the DMR XML to EPA until it has been properly
processed.
    Processing by ICIS. Once the sample submission has successfully
passed schema validation, CDX will distribute the file to ICIS for
processing. ICIS will return an XML file containing the list of key
fields for parameters able to be processed (``accepted
transactions'') along with an XML file of parameters unable to be
processed with error messages (``rejected transactions''). The
software provider will be responsible for downloading this report
through the download service provided by CDX and providing a means
for viewing these errors within their software package.
    Criteria for Success: The general criteria for successful
completion of the technical proof of concept by the software
provider are:
     Ability of the software provider's electronic reporting
software to use ICIS limit set information to determine when a
scheduled parameter is due in ICIS.
     Successful generation of the following types of sample
DMR XML files in the format expected by ICIS via the software
provider's electronic reporting software:
    [cir] DMRs with change, replace and mass delete transactions
being submitted at the same time for one or more permitted
facilities;
    [cir] One permitted facility having over 25 unique outfalls with
parameters being reported at the same time;
    [cir] One permitted facility having over 25 unique parameters
being reported at the same time;
    [cir] Multi-seasonal parameters being reported with non-seasonal
parameters at the same time for one or more permitted facilities;
    [cir] Parameters monitored monthly, quarterly, annually and
semi-annually being reported at the same time for one or more
permitted facilities;
    [cir] Scheduled parameters and unscheduled parameters being
reported at the same time for one or more permitted facilities;
    [cir] Monitored and optionally monitored parameters being
reported at the same time for one or more permitted facilities;
    [cir] Biosolids data being reported with parameter values at the
same time for one or more permitted facilities;
    [cir] Parameters for one or more sewage treatment plants being
reported for one or more permitted facilities;
    [cir] Parameters with reported values, parameters with No
Discharge Indicators, and parameters with a combination of reported
values and No Discharge Indicators being reported at the same time
for one or more permitted facilities; and
    [cir] DMRs that are able to pass all business rules specified in
the ICIS Batch Technical Specification Document.
     Successful authentication and electronic submission of
all types of sample DMR XML files listed above to CDX via the
software provider's electronic reporting software.
     Ability to receive, track and interpret CDX notices on
the status of each DMR XML file submission.
     Ability of all types of sample DMR XML files to pass
initial schema validation by CDX.
     Successful retrieval of CDX schema validation result
reports and ICIS error reports in XML format for each submission to
CDX, and use the reports to perform defect correction and
resubmission of corrected DMR XML files as necessary.
     100% success in the ability of ICIS to process all of
the sample DMR XML files listed above.
     Ability for the software provider's electronic
reporting software to receive, parse and process accepted and
rejected transaction reports returned by ICIS for each CDX
submission with a status of ``Completed'' in XML format, and
translate them into a human readable format for the submitter to
review.

[FR Doc. 2011-15642 Filed 6-22-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 218 (Tuesday, November 14, 2017)]
[Notices]
[Pages 52718-52719]
[FR Doc No: 2017-24580]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: ER14-2154-007.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Compliance filing: 2017-11-07_Rate Schedule 34_SMMPA-
RPU Joint Pricing Zone Agreement to be effective 12/1/2014.
    Filed Date: 11/7/17.
    Accession Number: 20171107-5158.
    Comments Due: 5 p.m. ET 11/28/17.

    Docket Numbers: ER16-1480-002.
    Applicants: Midcontinent Independent System Operator, Inc., White
Pine Electric Power L.L.C.
    Description: Compliance filing: 2017-11-07_SA 6507 White Pine 1 SSR
Agreement Reflecting Settlement to be effective 4/16/2016.
    Filed Date: 11/7/17.
    Accession Number: 20171107-5096.
    Comments Due: 5 p.m. ET 11/28/17.

    Docket Numbers: ER17-615-001.
    Applicants: Albany Green Energy, LLC.
    Description: Notice of Change in Status of Albany Green Energy,
LLC.
    Filed Date: 11/6/17.
    Accession Number: 20171106-5350.
    Comments Due: 5 p.m. ET 11/27/17.

    Docket Numbers: ER17-2470-000; ER17-2457-000.
    Applicants: Red Dirt Wind Project, LLC, Rock Creek Wind Project,
LLC.
    Description: Second Amendment to September 13, 2017 Red Dirt Wind
Project, LLC tariff filing, et al.
    Filed Date: 11/2/17.
    Accession Number: 20171102-5148.
    Comments Due: 5 p.m. ET 11/24/17.

    Docket Numbers: ER18-255-000.
    Applicants: Canton Mountain Wind, LLC.
    Description: Sec.  205(d) Rate Filing: Certificate of Concurrence
to be effective 11/7/2017.
    Filed Date: 11/6/17.
    Accession Number: 20171106-5338.
    Comments Due: 5 p.m. ET 11/27/17.

    Docket Numbers: ER18-256-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original WMPA, Service
Agreement No. 4839, Queue No. AC2-009 to be effective 10/12/2017.
    Filed Date: 11/7/17.
    Accession Number: 20171107-5115.
    Comments Due: 5 p.m. ET 11/28/17.

    Docket Numbers: ER18-257-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: Letter Agreements with
Hecate Energy Johanna Facility LLC to be effective 11/8/2017.
    Filed Date: 11/7/17.
    Accession Number: 20171107-5129.
    Comments Due: 5 p.m. ET 11/28/17.

    Docket Numbers: ER18-258-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to ISA No. 1787,
Queue S63 to be effective 10/5/2007.

    Filed Date: 11/7/17.
    Accession Number: 20171107-5150.
    Comments Due: 5 p.m. ET 11/28/17.

    Docket Numbers: ER18-260-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to SA Nos. 1570,
2510 and 2534 re: Dayton transfer to AES Ohio to be effective 5/17/
2010.
    Filed Date: 11/7/17.
    Accession Number: 20171107-5179.
    Comments Due: 5 p.m. ET 11/28/17.

    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 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: November 7, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-24580 Filed 11-13-17; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 69 (Wednesday, April 10, 2019)]
[Notices]
[Pages 14368-14372]
[FR Doc No: 2019-07094]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2018-0411; FRL-9990-59]

Certain New Chemicals; Receipt and Status Information for
December 2018

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA),
as amended by the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, to make information publicly available and to publish
information in the Federal Register pertaining to submissions under
TSCA Section 5, including notice of receipt of a Premanufacture notice
(PMN), Significant New Use Notice (SNUN) or Microbial Commercial
Activity Notice (MCAN), including an amended notice or test
information; an exemption application (Biotech exemption); an
application for a test marketing exemption (TME), both pending and/or
concluded; a notice of commencement (NOC) of manufacture (including
import) for new chemical substances; and a periodic status report on
new chemical substances that are currently under EPA review or have
recently concluded review. This document covers the period from 12/01/
2018 to 12/31/2018.

DATES: Comments identified by the specific case number provided in this
document must be received on or before May 10, 2019.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2018-0411, and the specific case number for the
chemical substance related to your comment, by one of the following
methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim
Rahai, Information Management Division (7407M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-8593; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. What action is the Agency taking?

    This document provides the receipt and status reports for the
period from 12/01/2018 to 12/31/2018. The Agency is providing notice of
receipt of PMNs, SNUNs and MCANs (including amended notices and test
information); an exemption application under 40 CFR part 725 (Biotech
exemption); TMEs, both pending and/or concluded; NOCs to manufacture a
new chemical substance; and a periodic status report on new chemical
substances that are currently under EPA review or have recently
concluded review.
    EPA is also providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a
weekly basis.

B. What is the Agency's authority for taking this action?

    Under the TSCA, 15 U.S.C. 2601 et seq., a chemical substance may be
either an ``existing'' chemical substance or a ``new'' chemical
substance. Any chemical substance that is not on EPA's TSCA Inventory
of Chemical Substances (TSCA Inventory) is classified as a ``new
chemical substance,'' while a chemical substance that is listed on the
TSCA Inventory is classified as an ``existing chemical substance.''
(See TSCA section 3(11).) For more information about the TSCA Inventory
go to: https://www.epa.gov/tsca-inventory.
    Any person who intends to manufacture (including import) a new
chemical substance for a non-exempt commercial purpose, or to
manufacture or process a chemical substance in a non-exempt manner for
a use that EPA has determined is a significant new use, is required by
TSCA section 5 to provide EPA with a PMN, MCAN or SNUN, as appropriate,
before initiating the activity. EPA will review the notice, make a risk
determination on the chemical substance or significant new use, and
take appropriate action as described in TSCA section 5(a)(3).
    TSCA section 5(h)(1) authorizes EPA to allow persons, upon
application and under appropriate restrictions, to manufacture or
process a new chemical substance, or a chemical substance subject to a
significant new use rule (SNUR) issued under TSCA section 5(a)(2), for
``test marketing'' purposes, upon a showing that the manufacture,
processing, distribution in commerce, use, and disposal of the chemical
will not present an unreasonable risk of injury to health or the
environment. This is referred to as a test marketing exemption, or TME.
For more information about the requirements applicable to a new
chemical go to: http://www.epa.gov/oppt/newchems.
    Under TSCA sections 5 and 8 and EPA regulations, EPA is required to
publish in the Federal Register certain information, including notice
of receipt of a PMN/SNUN/MCAN (including amended notices and test
information); an exemption application under 40 CFR part 725 (biotech
exemption); an application for a TME, both pending and concluded; NOCs
to manufacture a new chemical substance; and a periodic status report
on the new chemical substances that are currently under EPA review or
have recently concluded review.

C. Does this action apply to me?

    This action provides information that is directed to the public in
general.

D. Does this action have any incremental economic impacts or paperwork
burdens?

    No.

E. What should I consider as I prepare my comments for EPA?

    1. Submitting confidential business information (CBI). Do not
submit this information to EPA through regulations.gov or email.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark
the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Status Reports

    In the past, EPA has published individual notices reflecting the
status of TSCA section 5 filings received, pending or concluded. In
1995, the Agency modified its approach and streamlined the information
published in the Federal Register after providing notice of such
changes to the public and an opportunity to comment (See the Federal
Register of May 12, 1995 (60 FR 25798) (FRL-4942-7). Since the passage
of the Lautenberg amendments to TSCA in 2016, public interest in
information on the status of section 5 cases under EPA review and, in
particular, the final determination of such cases, has increased. In an
effort to be responsive to the regulated community, the users of this
information, and the general public, to comply with the requirements of
TSCA, to conserve EPA resources and to streamline the process and make
it more timely, EPA is providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a
weekly basis.

III. Receipt Reports

    For the PMN/SNUN/MCANs received by EPA during this period, Table I
provides the following information (to the extent that such information
is not subject to a CBI claim) on the notices received by EPA during
this period: The EPA case number assigned to the notice that indicates
whether the submission is an initial submission, or an amendment, a
notation of which version was received, the date the notice was
received by EPA, the submitting manufacturer (i.e., domestic producer
or importer), the potential uses identified by the manufacturer in the
notice, and the chemical substance identity.
    As used in each of the tables in this unit, (S) indicates that the
information in the table is the specific information provided by the
submitter, and (G) indicates that this information in the table is
generic information because the specific information provided by the
submitter was claimed as CBI. Submissions which are initial submissions
will not have a letter following the case number. Submissions which are
amendments to previous submissions will have a case number followed by
the letter ``A'' (e.g., P-18-1234A). The version column designates
submissions in sequence as ``1'', ``2'', ``3'', etc. Note that in some
cases, an initial submission is not numbered as version 1; this is
because earlier versions were rejected as incomplete or invalid
submissions. Note also that future versions of the following tables may
adjust slightly as the Agency works to automate population of the data
in the tables.

                         Table I--PMN/SNUN/MCANs Received From 12/01/2018 to 12/31/2018
----------------------------------------------------------------------------------------------------------------
                                                                                Chemical
           Case No.              Version    Received date     Manufacturer           Use            substance
----------------------------------------------------------------------------------------------------------------
J-19-0011.....................          1      12/23/2018  Danisco US, Inc..  (G) Production    (G) Genetically
                                                                               of a chemical     modified
                                                                               substance.        microorganism
                                                                                for the
                                                                                production of a
                                                                                chemical
                                                                                substance.
P-19-0011.....................          4      12/20/2018  Shin etsu          (G) Additive to   (G)
                                                            Silicones of       the EPDM rubber   Polysulfides,
                                                            America.           compounds.        bis[3-
                                                                                (trialkoxysilyl
                                                                                )propyl].
P-19-0030.....................          2      12/18/2018  CBI..............  (G) Water         (G)
                                                                               Systems.          Triethanolamine
                                                                                modified
                                                                                Phosphinicocarb
                                                                                oxylates,
                                                                                sodium salts.
P-19-0031.....................          2      12/28/2018  CBI..............  (S) Curing agent  (G) Phenol, 4,4'-
                                                                               for epoxy         (1-
                                                                               coating systems.  methylethyliden
                                                                                e)bis-, polymer
                                                                                with
                                                                                formaldehyde, 2-
                                                                                (chloromethyl)o
                                                                                xirane, alpha-
                                                                                hydro-omega-
                                                                                hydroxypoly(oxy-
                                                                                1,2-
                                                                                ethanediyl),
                                                                                and polyamines.
P-19-0034.....................          1       12/6/2018  CBI..............  (G) Contained     (G) Metal,
                                                                               use as a          bis(2,4-
                                                                               component of      pentanedionato-
                                                                               tires.            kO2,kO4)-, (T-
                                                                                4)-.
P-19-0035.....................          3      12/10/2018  Firmenich, Inc...  (G) Fragrance...  (S) Acetamide, 2-
                                                                                (4-
                                                                                methylphenoxy)-
                                                                                N-1H-pyrazol-3-
                                                                                yl-N-(2-
                                                                                thienylmethyl)-
                                                                                .
P-19-0036.....................          1      12/10/2018  Ethox Chemicals,   (S) As an         (S) 1,4-
                                                            LLC.               additive to       Benzenedicarbox
                                                                               polymers for      ylic acid, 1,4-
                                                                               improvement in    bis(2-
                                                                               gas barrier       phenoxyethyl)
                                                                               performance.      ester.

P-19-0037.....................          1      12/11/2018  CBI..............  (G) Chemical      (G) D-Glucaric
                                                                               intermediate.     acid, mixed
                                                                                alkali metal
                                                                                salt.
P-19-0038.....................          2      12/14/2018  Allan Chemical     (S) Ink carrier   (S) Fatty acids,
                                                            Corporation.       for the ceramic   coco, iso-Bu
                                                                               industries.       esters.
P-19-0040.....................          1      12/20/2018  CBI..............  (G) Intermediate  (G) Alkyl
                                                                                bis(dialkylamin
                                                                                o alkyl) amide.
P-19-0041.....................          1      12/20/2018  CBI..............  (G) Oil water     (G) Alkyl
                                                                               separation.       diester,
                                                                                polymer with
                                                                                (dialkylamino
                                                                                alkyl) amine
                                                                                and
                                                                                bis(halogenated
                                                                                alkyl) ether.
P-19-0042.....................          1      12/20/2018  CBI..............  (G) Oil water     (G) Alkyl
                                                                               separation.       diester,
                                                                                polymer with
                                                                                (dialkylamino
                                                                                alkyl) amine
                                                                                and
                                                                                bis(halogenated
                                                                                alkyl) ether.
P-19-0043.....................          1      12/20/2018  CBI..............  (G) Oil water     (G) Alkyl
                                                                               separation.       dicarboxylic
                                                                                acid, polymer
                                                                                with
                                                                                (dialkylamino
                                                                                alkyl) amine
                                                                                and
                                                                                bis(halogenated
                                                                                alkyl) ether.
P-19-0044.....................          1      12/20/2018  CBI..............  (G) Oil water     (G) Alkyl
                                                                               separation.       bis(dialkylamin
                                                                                o alkyl) amide
                                                                                polymer with
                                                                                bis(halogenated
                                                                                alkyl) ether.
P-19-0045.....................          1      12/21/2018  CBI..............  (G) Component of  (G) Non-metal
                                                                               textile coating.  tetrakis
                                                                                (hydroxyalkyl)-
                                                                                , halide,
                                                                                polymer with
                                                                                amide oxidized.
SN-19-0002....................          2      12/20/2018  Otsuka Chemical    (G) Friction and  (G) Potassium
                                                            America, Inc.      wear stabilizer   Titanate.
                                                                               in certain
                                                                               solid composite
                                                                               articles.
----------------------------------------------------------------------------------------------------------------

    In Table II. of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the NOCs
received by EPA during this period: The EPA case number assigned to the
NOC including whether the submission was an initial or amended
submission, the date the NOC was received by EPA, the date of
commencement provided by the submitter in the NOC, a notation of the
type of amendment (e.g., amendment to generic name, specific name,
technical contact information, etc.) and chemical substance identity.

                              Table II--NOCs Received From 12/01/2018 to 12/31/2018
----------------------------------------------------------------------------------------------------------------
                                                     Commencement   If amendment, type of
             Case No.                Received date       date             amendment          Chemical substance
----------------------------------------------------------------------------------------------------------------
J-16-0021.........................      12/04/2018      12/04/2018  .....................  (G) Modified
                                                                                trichoderma reesei.
J-18-0026.........................      12/21/2018      11/30/2018  .....................  (G) Biopolymer
                                                                                producing modified
                                                                                microorganism(s),
                                                                                with chromosomally-
                                                                                borne modifications.
J-18-0027.........................      12/21/2018      12/07/2018  .....................  (G) Biopolymer
                                                                                producing modified
                                                                                microorganism(s),
                                                                                with chromosomally-
                                                                                borne modifications.
J-18-0044.........................      12/21/2018      11/26/2018  .....................  (S) Saccharomyces
                                                                                cerevisae NE095.
P-12-0168.........................      12/13/2018      12/07/2018  .....................  (S) 1,3,5-Triazine-
                                                                                2,4,6-triamine, N-
                                                                                (4,6-diamino-1,3,5-
                                                                                triazin-2-yl)-.
P-16-0150.........................      12/20/2018      11/29/2018  .....................  (G)
                                                                                Chlorofluorocarbon.
P-16-0173A........................      12/20/2018      06/06/2016  Updated CBI            (G) Aminoalkyl
                                                                     substantiation for     alaninate sodium
                                                                     importing site and     salt (1:1), polymer
                                                                     update to generic      with alkyldiol,
                                                                     chemical name.         dialkyl-alkanediol,
                                                                                alkyldioic acid,
                                                                                alkyldiol, polyol,
                                                                                cycloaliphatic
                                                                                diisocyanate,
                                                                                polyalkylene glycol
                                                                                mono-alkyl ether-
                                                                                blocked.
P-16-0221.........................      12/14/2018      12/13/2018  .....................  (G) Fluorinated
                                                                                organopolysilazane.
P-17-0330.........................      12/11/2018      12/03/2018  .....................  (G) Hexanedioic acid,
                                                                                polymer with
                                                                                trifuntional polyol,
                                                                                1,1'-methylenebis
                                                                                [isocyanatobenzene],
                                                                                and 2,2'-oxybis
                                                                                [ethanol].
P-17-0332.........................      12/14/2018      11/20/2018  .....................  (G) Benzenesulfonic
                                                                                acid,
                                                                                (alkenediyl)bis[[[(h
                                                                                ydroxyalkyl)amino]-
                                                                                (phenylamino)-
                                                                                triazin-2-yl]amino]-
                                                                                , N-(hydroxyalkyl)
                                                                                derivs., salts.
P-18-0002.........................      12/05/2018      12/05/2018  .....................  (S) Phosphinic acid,
                                                                                P,P-diethyl-, sodium
                                                                                salt (1:1).
P-18-0147.........................      12/13/2018      11/29/2018  .....................  (G) Phenol, 4-ethenyl-
                                                                                , 1-substituted,
                                                                                polymer with 1-(1,1-
                                                                                substituted)-4-
                                                                                ethenylbenzene and
                                                                                ethenylbenzene, 2,
                                                                                2'-(1,2-
                                                                                diazenediyl)bis[2-
                                                                                substituted]-
                                                                                initiated,
                                                                                hydrolyzed.

P-18-0212.........................      12/11/2018      12/07/2018  .....................  (G) Substituted
                                                                                carbomonocycle,
                                                                                polymer with alkyl
                                                                                alkenoate, alkenyl
                                                                                substituted
                                                                                carbomonocycle,
                                                                                substituted
                                                                                alkanediol,
                                                                                heteropolycycle,
                                                                                alkylene glycol and
                                                                                alkenoic acid,
                                                                                compd. with
                                                                                alkylamino alkanol.
P-18-0261.........................      12/06/2018      12/05/2018  .....................  (G) Metal,
                                                                                alkylcarboxylate oxo
                                                                                complexes.
P-18-0279.........................      12/17/2018      12/14/2018  .....................  (G) Substituted
                                                                                heteromonocycle,
                                                                                polymer with
                                                                                substituted
                                                                                alkanediol and
                                                                                diisocyanate
                                                                                substituted
                                                                                carbomonocyle,
                                                                                alkylene glycol
                                                                                acrylate-blocked.
----------------------------------------------------------------------------------------------------------------

    In Table III. of this unit, EPA provides the following information
(to the extent such information is not subject to a CBI claim) on the
test information received by EPA during this time period: The EPA case
number assigned to the test information; the date the test information
was received by EPA, the type of test information submitted, and
chemical substance identity.

                       Table III--Test Information Received From 12/01/2018 to 12/31/2018
----------------------------------------------------------------------------------------------------------------
                Case No.                   Received date   Type of test information       Chemical substance
----------------------------------------------------------------------------------------------------------------
P-00-0281...............................       12/4/2018  Fish Acute Toxicity (OECD   (G) Alkarylsulfonic acid,
                                                           203) Invertebrate Acute     sodium salts.
                                                           Toxicity (Fathead
                                                           minnows), Algae Toxcitiy
                                                           (Raphidocelis
                                                           subcapitata).
SN-17-0011..............................       12/4/2018  Whole Body (Inhalation) 2   (G) Polyfluorohydrocarbon.
                                                           Generation Reproductive
                                                           Toxicity Study and Work
                                                           Place Air Monitoring and
                                                           Exposure Modeling Study.
P-87-1436...............................       12/6/2018  QSAR Assessment Report on   (S) Dodecanoic acid,
                                                           Vinyl Laurate; Skin         ethenyl ester.
                                                           Sensitization: Local
                                                           Lymph Node Assay (OECD TG
                                                           429); Repeated Does 90-
                                                           Day Oral Toxicity in
                                                           Rodents (OECD TG 408);
                                                           Repeated Dose Toxicity
                                                           and Repro/Devel Toxicity
                                                           Screening (OECD TG 422);
                                                           Chromosome Aberration
                                                           Test (OECD TG 473); Gene
                                                           Mutation Assay (OECD TG
                                                           476); Micronucleus Test
                                                           (OECD TG 474); Prenatal
                                                           Developmental Toxicity
                                                           Study (OECD TG 414);
                                                           Aquatic Toxicity--Daphnia
                                                           (OECD TG 202); Aquatic
                                                           Toxicity--Daphnia
                                                           Reproductive (OECD TG
                                                           211); Aquatic Toxicity--
                                                           Algal Growth (OECD TG
                                                           201); Ready
                                                           Biodegradability (OECD TG
                                                           301); Dermal Irritation/
                                                           Corrosion (OECD TG 404);
                                                           Bacterial Reverse
                                                           Mutation Assay--Ames Test
                                                           (OECD 471); Fish Acute
                                                           Toxicity (OECD TG 203);
                                                           Activated Sludge Test
                                                           (OECD TG 209); Acute Oral
                                                           Toxicity (OECD TG 401);
                                                           Acute Eye Irritation
                                                           (OECD TG 405); Acute
                                                           Dermal Toxicity (OECD TG
                                                           402). Note: There are no
                                                           additional processing and
                                                           use requests beyond the
                                                           original PMN, except for
                                                           allowing our site limited
                                                           use as a monomer in
                                                           polymer production. Added
                                                           commentary on EPA Risk
                                                           Assessment.
P-11-0483...............................       12/7/2018  Routine/Annual Testing and  (G) Alkyl thiol.
                                                           Reporting: Certifications
                                                           of Analysis.
P-11-0484...............................       12/7/2018  Routine/Annual Testing and  (G) Alkyl sulfate salt.
                                                           Reporting: Certifications
                                                           of Analysis.
P-11-0487...............................       12/7/2018  Routine/Annual Testing and  (G) Alkyl polyamide.
                                                           Reporting: Certifications
                                                           of Analysis.
P-11-0527...............................       12/7/2018  Routine/Annual Testing and  (G) Substituted
                                                           Reporting: Certifications   fluoroalkane.
                                                           of Analysis.
P-11-0528...............................       12/7/2018  Routine/Annual Testing and  (G) Fluorinated thiol.
                                                           Reporting: Certifications
                                                           of Analysis.
P-11-0529...............................       12/7/2018  Routine/Annual Testing and  (G) Fluorinated monomer.
                                                           Reporting: Certifications
                                                           of Analysis.
P-11-0530...............................       12/7/2018  Routine/Annual Testing and  (G) Fluoropolyacrylamide.
                                                           Reporting: Certifications
                                                           of Analysis.
P-11-0532...............................       12/7/2018  Routine/Annual Testing and  (G) Polyfluoroalkyl amine.
                                                           Reporting: Certifications
                                                           of Analysis.
P-11-0533...............................       12/7/2018  Routine/Annual Testing and  (G) Non-ionic
                                                           Reporting: Certifications   fluorosurfactant.
                                                           of Analysis.
P-11-0534...............................       12/7/2018  Routine/Annual Testing and  (G) Anionic
                                                           Reporting: Certifications   fluorosurfactant.
                                                           of Analysis.
P-11-0543...............................       12/7/2018  Routine/Annual Testing and  (G) Polyfluorinated alkyl
                                                           Reporting: Certifications   quaternary amine
                                                           of Analysis.                chloride.
P-17-0115...............................      12/11/2018  Skin Sensitization: Local   (G) Aminoalkyl
                                                           Lymph Node Assay (OECD      alkoxysilane.
                                                           Test Guideline 429).
P-17-0337...............................      12/12/2018  Industrial Hygiene          (S) Aluminum cobalt
                                                           Monitoring Report.          lithium nickel oxide.
P-18-0382...............................      12/10/2018  Consumer Exposure Data....  (G) Xanthylium,
                                                                                bis[dicarboxycyclic]
                                                                                sulfonylamino-
                                                                                alkylcyclicamino-disulfo-
                                                                                sulfocyclic-, inner salt,
                                                                                monocationic salt.
----------------------------------------------------------------------------------------------------------------

    If you are interested in information that is not included in these
tables, you may contact EPA's technical information contact or general
information contact as described under FOR FURTHER INFORMATION CONTACT
to access additional non-CBI information that may be available.

    Authority: 15 U.S.C. 2601 et seq.

    Dated: March 7, 2019.
Pamela Myrick,
Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2019-07094 Filed 4-9-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 69 (Tuesday, April 11, 2023)]
[Notices]
[Pages 21677-21679]
[FR Doc No: 2023-07524]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1006]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Reports of Corrections and Removals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with reports of removals and corrections for medical and
radiation emitting products regulated by FDA's Center for Devices and
Radiological Health.

DATES: Either electronic or written comments on the collection of
information must be submitted by June 12, 2023.

ADDRESSES: You may submit comments as follows. 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 June 12, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.

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-1006 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Devices; Reports of
Corrections and Removals.'' 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.'' The Agency 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 to 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 this 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: JonnaLynn Capezzuto, 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: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Medical Devices; Reports of Corrections and Removals--21 CFR Part 806

OMB Control Number 0910-0359--Revision

    This information collection supports implementation of provisions
of section 519(g) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360i(g)) requiring device manufacturers and importers to report
promptly to FDA certain actions concerning device corrections and
removals and to maintain associated records. Applicable regulations are
found in 21 CFR part 806 and set forth definitions, prescribe format
and required content elements for reporting, and identify actions that
are exempt from the reporting requirements. The information collected
is used by FDA to identify marketed devices that have serious problems
and to ensure that defective devices are removed from the market. The
information also helps ensure that FDA has current and complete
information regarding these corrections and removals to determine
whether recall action is adequate.
    Reports of corrections and removals may be submitted to FDA via
mail, email, or using FDA's Electronic Submission Gateway (ESG). To
assist respondents with submitting reports of corrections or removals,
we developed a fillable PDF electronic submission template entitled,
``Device Correction/Removal Report for Industry,'' that transmits
required data to FDA's Recall Enterprise System. Instructions for the
fillable template are provided in pop-up text boxes that appear over
each data field. We expect that use of the fillable template will
expedite processing of the reports of corrections or removals submitted
to FDA.
    We estimate the burden of the information collection as follows:

                                                       Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total
                                                             Number of       Number of     Total annual       Average                      operating and
            21 CFR part; collection activity                respondents    responses per     responses      burden per      Total hours     maintenance
                                                                            respondent                       response                          costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Electronic process setup................................             517               1             517            3.08           1,592         $25,850
806; Submission of corrections and removals.............           1,033               1           1,033              10          10,330  ..............
4.102(c)(1)(iii)); Submitting correction or removal                   20               1              20              10             200  ..............
 reports................................................
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............          25,850
--------------------------------------------------------------------------------------------------------------------------------------------------------

    For respondents who submit corrections and removals using the ESG,
the operating and maintenance costs associated with this information
collection are approximately $50 per year to purchase a digital
verification certificate (certificate must be valid for 1 to 3 years).
This burden may be reduced if the respondent has already purchased a
verification certificate for other electronic submissions to FDA. This
burden may also be reduced if respondents utilize the new PDF template
and submit it to the Agency using email, mitigating the need for a
digital verification certificate.

                             Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average  burden
    21 CFR part; collection        Number of      records per    Total annual          per          Total hours
           activity              recordkeepers   recordkeeper       records       recordkeeping
----------------------------------------------------------------------------------------------------------------
806; Records of corrections                 93               1              93  10..............             930
 and removals.
4.105(b); recordkeeping by                 279               1             279  0.5 (30 minutes)             140
 device-led combination
 products.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           1,070
----------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Figures have been rounded.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. We estimate that 50 percent of submitters will use the ESG to
submit the required information. Our estimate of the reporting and
recordkeeping burden is based on Agency records and our experience with
this program, as well as similar programs that utilize FDA's ESG. For
the purposes of estimating the burden, we assume that all respondents
who submit corrections and removals using the electronic process will
establish a new WebTrader account and purchase a digital verification
certificate.

    Dated: April 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07524 Filed 4-10-23; 8:45 am]
BILLING CODE 4164-01-P


 [Federal Register: October 23, 2009 (Volume 74, Number 204)] [ Notices]                [Page 54864-54865] [DOCID:fr23oc09-88]

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SECURITIES AND EXCHANGE COMMISSION

  Proposed Collection; Comment Request

Upon Written Request, Copies Available From: U.S. Securities and

Exchange Commission, Office of Investor Education and Advocacy,

Washington, DC 20549-0213.

Extension:

    Rule 17i-6; SEC File No. 270-532; OMB Control No. 3235-0588.

    Notice is hereby given that pursuant to the Paperwork Reduction Act

of 1995 \1\ the Securities and Exchange Commission (``Commission'') has

submitted to the Office of Management and Budget requests for extension

of the previously approved collections of information discussed below.

The Code of Federal Regulations citation to this collection of

information is the following: 17 CFR 240.17i-6.

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    \1\ 44 U.S.C. 3501 et seq.

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

    Section 231 of the Gramm-Leach-Bliley Act of 1999 \2\ (the

``GLBA'') amended Section 17 of the Securities Exchange Act of 1934 to

create a regulatory framework under which a holding company of a

broker-dealer (``investment bank holding company'' or ``IBHC'') may

voluntarily be supervised by the Commission as a supervised investment

bank holding company (or ``SIBHC'').\3\ In 2004, the Commission

promulgated rules, including Rule 17i-6, to create a framework for the

Commission to supervise SIBHCs.\4\ This framework includes

qualification criteria for SIBHCs, as well as recordkeeping and

reporting requirements. Among other things, this regulatory framework

for SIBHCs is intended to provide a basis for non-U.S. financial

regulators to treat the Commission as the principal U.S. consolidated

home-country supervisor for SIBHCs and their affiliated broker-

dealers.\5\

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    \2\ Pub. L. No. 106-102, 113 Stat. 1338 (1999).

    \3\ See 15 U.S.C. 78q(i).

    \4\ See Exchange Act Release No. 49831 (Jun. 8, 2004), 69 FR

34472 (Jun. 21, 2004).

    \5\ See H.R. Conf. Rep. No. 106-434, 165 (1999). See also

Exchange Act Release No. 49831, at 6 (Jun. 8, 2004), 69 FR 34472, at

34473 (Jun. 21, 2004).

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    Pursuant to Section 17(i)(3)(A) of the Exchange Act, an SIBHC must

make and keep records, furnish copies thereof, and make such reports as

the Commission may require by rule.\6\ Rule 17i-6 requires that an

SIBHC file with the Commission certain monthly and quarterly reports

and an annual audit report. The reports and notices required to be

filed pursuant to Rule 17i-6 must be preserved for a period of not less

than three years.\7\

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

    \6\ 15 U.S.C. 78q(i)(3)(A).

    \7\ 17 CFR 240.17i-5(b)(3).

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

    The collections of information required by Rule 17i-6 are necessary

to allow the Commission adequately to supervise the activities of these

SIBHCs and to effectively determine whether supervision of an IBHC as

an SIBHC is necessary or appropriate in furtherance of the purposes of

Section 17 of the Act. Rule 17i-6 also enhances the Commission's

supervision of an SIBHC's subsidiary broker-dealers through collection

of additional information and inspections of affiliates of those

broker-dealers. Without these reports, the Commission would be unable

to adequately supervise an SIBHC, nor would it be able to determine

whether continued supervision of an IBHC as an SIBHC were necessary and

appropriate in furtherance of the purposes of Section 17 of the Act.

    We estimate that three IBHCs will file Notices of Intention with

the Commission to be supervised by the Commission as SIBHCs. An SIBHC

will require about 8 hours to prepare and file each monthly report

required by this rule (or approximately 96 hours per year).\8\ On

average, it will take an SIBHC about 16 hours each quarter (or 64 hours

each year) \9\ to prepare and file the quarterly reports required by

this rule. An SIBHC will require about 200 hours to prepare and file

the annual audit reports required by this rule. Consequently, the total

annual burden of Rule 17i-6 on all SIBHCs is approximately 984

hours.\10\

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

    \8\ The SIBHC must file with the Commission a monthly report

within 30 calendar days after the end of each month that does not

coincide with a fiscal quarter end. Consequently, the SIBHC must

file a monthly report 8 times each year. (8 hours x 8 months) = 64

hours/year.

    \9\ (16 hours x 4 quarters in a year) = 64 hours/year.

    \10\ (64 hours per year to prepare and file monthly reports + 64

hours each year to prepare and file quarterly reports + 200 hours

each year to prepare and file annual audit reports) x 3 SIBHCs = 984

hours.

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

    Rule 17i-6 requires that an SIBHC file certain monthly and

quarterly reports with the Commission, as well as an annual audit

report. The average cost for an SIBHC to prepare and file the monthly

reports is about $1,424 per month, and thus approximately $11,392

per year.\11\ On average, an SIBHC will incur a quarterly cost of

$2,848 to prepare and file the required quarterly reports, and thus

will incur an annual cost of $11,392 to file these reports.\12\

Finally, an SIBHC, on average, will incur an annual cost of $40,400 to

prepare and file an annual audit.\13\ Thus, the total dollar cost of

the ongoing paperwork burden associated with Rule 17i-6 is

approximately $189,552.\14\

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    \11\ We believe that an SIBHC would have a Senior Accountant

prepare and file these reports. According to the Securities Industry

Financial Management Association (or ``SIFMA''), the hourly cost of

a Senior Accountant is $178, as reflected in the SIFMA's Report on

Management and Professional Earnings for 2008, and modified to

account for an 1,800-hour work-year and multiplied by 5.35 to

account for bonuses, firm size, employee benefits and overhead.

($178 x 8 hours) = $1,424. ($1,424 x 8 months) = $11,392.

    \12\ We believe that an SIBHC would have a Senior Accountant

prepare and file these reports. The hourly cost of a Senior

Accountant is $178. ($178 x 16 hours) = $2,848. ($2,848 x 4

quarters) = $11,392.

    \13\ We believe that an SIBHC would have a Senior Internal

Auditor work with accountants to prepare and file these reports.

According to the SIFMA, the hourly cost of a Senior Internal Auditor

is $202, as reflected in its Report on Management and Professional

Earnings for 2008, and modified to account for an 1,800-hour work-

year and multiplied by 5.35 to account for bonuses, firm size,

employee benefits and overhead. ($202 x 200 hours) = $40,400.

    \14\ (($11,392 + $11,392 + $40,400) x 3 SIBHCs) = $189,552.

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

    We believe that an IBHC likely will upgrade its information

technology (``IT'') systems in order to more efficiently comply with

certain of the SIBHC framework rules (including Rules 17i-4, 17i-5,

17i-6 and 17i-7), and that this would be a one-time cost. Depending on

the state of development of the IBHC's IT systems, it would cost an

IBHC between $1 million and $10 million to upgrade its IT systems to

comply with the SIBHC framework of rules. Thus, on average, it would

cost each of the three IBHCs about $5.5 million to upgrade their IT

systems, or approximately $16.5 million in total. It is impossible to

determine what percentage of the IT systems costs would be attributable

to each Rule, so we allocated the total estimated upgrade costs equally

(at 25% for each of the above-mentioned Rules), with $4,125,000

attributable to Rule 17i-6.

    Written comments are invited on: (a) Whether the proposed

collection of information is necessary for the proper performance of

the functions of the agency, including whether the information shall

have practical utility; (b) the accuracy of the agency's estimate of

the burden of the proposed collection of information; (c) ways to

enhance the quality, utility, and clarity of the information to be

collected; and (d) ways to minimize the burden of the collection of

information on respondents, including through the use of automated

collection techniques or other forms of information technology.

Consideration will be given to comments and suggestions submitted in

writing within 60 days of this publication.

    Comments should be directed to Charles Boucher, Director/Chief

Information Officer, Securities and Exchange Commission, c/o Shirley

Martinson, 6432 General Green Way, Alexandria, Virginia 22312 or send

an e-mail to<EMAIL_ADDRESS>

    Dated: October 19, 2009.

Florence E. Harmon,

Deputy Secretary.

[FR Doc. E9-25486 Filed 10-22-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 147 (Friday, July 31, 2015)]
[Notices]
[Page 45652]
[FR Doc No: 2015-18838]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP15-535-000]

National Fuel Gas Supply Corporation; Notice of Request Under
Blanket Authorization

    Take notice that on July 17, 2015, National Fuel Gas Supply
Corporation (National Fuel) 6363 Main Street, Williamsville, New York
14221, filed in Docket No. CP15-535-000 a prior notice request pursuant
to sections 157.205 and 157.216 of the Commission's regulations under
the Natural Gas Act for authorization to abandon certain minor
underground natural gas storage facilities within the Colden Storage
Field in Erie County, New York, under its blanket certificate issued in
Docket No. CP83-4-000, all as more fully set forth in the application
which is on file with the Commission and open to public inspection. The
filing may also be viewed on the Web at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed Kenneth
E. Webster, Attorney for National Fuel, 6363 Main Street,
Williamsville, New York 14221, at<PHONE_NUMBER>.
    Specifically, National Fuel proposes to abandon three observation
wells: 1013-I, 1028-I and 1229-I (within the Colden Storage Field).
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's Regulations under
the Natural Gas Act (NGA) (18 CFR 157.205) file a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for protest. If a protest is filed and not
withdrawn within 30 days after the time allowed for filing a protest,
the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the Internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (www.ferc.gov) under the ``e-Filing'' link.

    Dated: July 27, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-18838 Filed 7-30-15; 8:45 am]
 BILLING CODE 6717-01-P