[Federal Register Volume 80, Number 172 (Friday, September 4, 2015)]
[Notices]
[Pages 53508-53509]
[FR Doc No: 2015-21988]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP15-137-000]

Rockies Express Pipeline LLC; Notice of Availability of the
Environmental Assessment for the Proposed Zone 3 Capacity Enhancement
Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared an environmental assessment (EA) for the Zone
3 Capacity Enhancement Project, proposed by Rockies Express Pipeline
LLC (REX) in the above-referenced docket. REX requests authorization to
construct and operate natural gas compression facilities in Fayette,
Pickaway, Muskingum, and Warren Counties, Ohio and Decatur County,
Indiana. The REX Zone 3 Capacity Enhancement Project would provide an
additional 800 million cubic feet per day of east-to-west
transportation service.
    The EA assesses the potential environmental effects of the
construction and operation of the Zone 3 Capacity Enhancement Project
in accordance with the requirements of the National Environmental
Policy Act. The FERC staff concludes that approval of the proposed
project, with appropriate mitigating measures, would not constitute a
major federal action significantly affecting the quality of the human
environment.
    The proposed REX Zone 3 Capacity Enhancement Project includes the
following facilities:
     One new 49,428 horsepower (hp) compressor station in
Pickaway County, Ohio (Columbus Compressor Station);
     one new 31,791 hp compressor station in Fayette County,
Ohio (Washington Court House Compressor Station);
     one new 37,038 hp compressor station in Decatur County,
Indiana (St. Paul Compressor Station);
     an additional 38,400 hp of compression, gas cooling
facilities, and a new power and control building at the existing
Chandlersville Compressor Station in Muskingum County, Ohio; and
     gas cooling facilities and a new power and control
building at the existing Hamilton Compressor Station in Warren County,
Ohio.
    The FERC staff mailed copies of the EA to federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American tribes;
potentially affected landowners and other interested individuals and
groups; newspapers and libraries in the project area; and parties to
this proceeding. In addition, the EA is available for public viewing on
the FERC's Web site (www.ferc.gov) using the eLibrary link. A limited
number of copies of the EA are available for distribution and public
inspection at: Federal Energy Regulatory Commission, Public Reference
Room, 888 First Street NE., Room 2A, Washington, DC 20426, (202) 502-
8371.
    Any person wishing to comment on the EA may do so. Your comments
should focus on the potential environmental effects, reasonable
alternatives, and measures to avoid or lessen environmental impacts.
The more specific your comments, the more useful they will be. To
ensure that the Commission has the opportunity to consider your
comments prior to making its decision on this project, it is important
that we receive your

comments in Washington, DC on or before September 30, 2015.
    For your convenience, there are three methods you can use to file
your comments to the Commission. In all instances, please reference the
project docket number (CP15-137-000) with your submission. The
Commission encourages electronic filing of comments and has expert
staff available to assist you at<PHONE_NUMBER> or<EMAIL_ADDRESS>    (1) You can file your comments electronically using the eComment
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for submitting brief,
text-only comments on a project;
    (2) You can also file your comments electronically using the
eFiling feature on the Commission's Web site (www.ferc.gov) under the
link to Documents and Filings. With eFiling, you can provide comments
in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on ``eRegister.'' You must select the type of filing you are making. If
you are filing a comment on a particular project, please select
``Comment on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the following address: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC
20426.
    Any person seeking to become a party to the proceeding must file a
motion to intervene pursuant to Rule 214 of the Commission's Rules of
Practice and Procedures (18 CFR 385.214).\1\ Only intervenors have the
right to seek rehearing of the Commission's decision. The Commission
grants affected landowners and others with environmental concerns
intervenor status upon showing good cause by stating that they have a
clear and direct interest in this proceeding which no other party can
adequately represent. Simply filing environmental comments will not
give you intervenor status, but you do not need intervenor status to
have your comments considered.
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    \1\ See the previous discussion on the methods for filing
comments.
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    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site (www.ferc.gov) using the eLibrary link. Click on the
eLibrary link, click on ``General Search,'' and enter the docket number
excluding the last three digits in the Docket Number field (i.e., CP15-
137). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: August 31, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-21988 Filed 9-3-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: February 12, 2007 (Volume 72, Number 28)]
[Notices]
[Page 6549-6550]
[DOCID:fr12fe07-60]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP99-518-099]

Gas Transmission Northwest Corporation; Notice of Negotiated
Rates

February 5, 2007.
    Take notice that on January 31, 2007, Gas Transmission Northwest
Corporation (GTN) tendered for filing as part of its FERC Gas Tariff,
Third Revised Volume No. 1-A, the following tariff sheets, to become
effective February 1, 2007:

Forty-Second Revised Sheet No. 15
Fifth Revised Sheet No. 19

    GTN states that a copy of this filing has been served on GTN's
jurisdictional customers and interested state regulatory agencies.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the

``eFiling'' link at http://www.ferc.gov. Persons unable to file

electronically should submit an original and 14 copies of the protest
or intervention to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible online at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E7-2268 Filed 2-9-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 205 (Friday, October 23, 2015)]
[Notices]
[Pages 64465-64468]
[FR Doc No: 2015-26913]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76189; File No. SR-FINRA-2015-038]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change Relating to the Series 27 Examination Program

October 19, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'' or ``SEA'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby
given that on October 13, 2015, Financial Industry Regulatory
Authority, Inc. (``FINRA'') filed with the Securities and Exchange
Commission (``SEC'' or ``Commission'') the proposed rule change as
described in Items I, II, and III below, which Items have been prepared
by FINRA. FINRA has designated the proposed rule change as
``constituting a stated policy, practice, or interpretation with
respect to the meaning, administration, or enforcement of an existing
rule'' under Section 19(b)(3)(A)(i) of the Act \3\ and Rule 19b-4(f)(1)
thereunder,\4\ which renders the proposal effective upon receipt of
this filing by the Commission. The Commission is publishing this notice
to solicit comments on the

proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(i).
    \4\ 17 CFR 240.19b-4(f)(1).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is filing revisions to the content outline and selection
specifications for the Financial and Operations Principal (Series 27)
examination program.\5\ The proposed revisions update the material to
reflect changes to the laws, rules and regulations covered by the
examination and to incorporate the functions and associated tasks
currently performed by a Financial and Operations Principal. In
addition, FINRA is proposing to make changes to the format of the
content outline. FINRA is not proposing any textual changes to the By-
Laws, Schedules to the By-Laws or Rules of FINRA.
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    \5\ FINRA also is proposing corresponding revisions to the
Series 27 question bank. FINRA is submitting this filing for
immediate effectiveness pursuant to Section 19(b)(3)(A) of the Act
and Rule 19b-4(f)(1) thereunder, and is not filing the question
bank. See Letter to Alden S. Adkins, Senior Vice President and
General Counsel, NASD Regulation, from Belinda Blaine, Associate
Director, Division of Market Regulation, SEC, dated July 24, 2000.
The question bank is available for SEC review.
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    The revised content outline is attached.\6\ The Series 27 selection
specifications have been submitted to the Commission under separate
cover with a request for confidential treatment pursuant to SEA Rule
24b-2.\7\
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    \6\ The Commission notes that the content outline is attached to
the filing, not to this Notice.
    \7\ 17 CFR 240.24b-2.
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    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA and at
the Commission's Public Reference Room.

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

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

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

1. Purpose
    Section 15A(g)(3) of the Act \8\ authorizes FINRA to prescribe
standards of training, experience, and competence for persons
associated with FINRA members. In accordance with that provision, FINRA
has developed examinations that are designed to establish that persons
associated with FINRA members have attained specified levels of
competence and knowledge, consistent with applicable registration
requirements under FINRA rules. FINRA periodically reviews the content
of the examinations to determine whether revisions are necessary or
appropriate in view of changes pertaining to the subject matter covered
by the examinations.
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    \8\ 15 U.S.C. 78o-3(g)(3).
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    NASD Rule 1022(b)(1) requires that each member that operates
pursuant to the provisions of SEA Rule 15c3-1(a)(1)(ii),\9\ SEA Rule
15c3-1(a)(2)(i) \10\ or SEA Rule 15c3-1(a)(8) \11\ shall designate as
Financial and Operations Principal \12\ those persons associated with
it, at least one of whom shall be its chief financial officer, who
perform the duties described in paragraph (b)(2) of the rule. The rule
provides that each person associated with a member who performs such
duties shall be required to register as a Financial and Operations
Principal with FINRA and shall pass an appropriate qualification
examination before such registration may become effective. Paragraph
(b)(2) of the rule provides that the term Financial and Operations
Principal shall mean a person associated with a member whose duties
include:
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    \9\ 17 CFR 240.15c3-1(a)(1)(ii). SEA Rule 15c3-1(a)(1)(ii)
addresses net capital requirements for brokers or dealers that elect
not to be subject to the Aggregate Indebtedness Standard of
paragraph (a)(1)(i) under Rule 15c3-1.
    \10\ 17 CFR 240.15c3-1(a)(2)(i). SEA Rule 15c3-1(a)(2)(i)
addresses net capital requirements for brokers or dealers that carry
customer accounts.
    \11\ 17 CFR 240.15c3-1(a)(8). SEA Rule 15c3-1(a)(8) addresses
net capital requirements for municipal securities brokers' brokers,
as defined under the rule.
    \12\ The term ``Limited Principal--Financial and Operations'' as
set forth in NASD Rule 1022(b) is referred to as ``Financial and
Operations Principal'' for purposes of this filing. The term
``principal'' is defined in NASD Rule 1021(b) (Definition of
Principal).
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     Final approval and responsibility for the accuracy of
financial reports submitted to any duly established securities industry
regulatory body;
     final preparation of such reports;
     supervision of individuals who assist in the preparation
of such reports;
     supervision of and responsibility for individuals who are
involved in the actual maintenance of the member's books and records
from which such reports are derived;
     supervision and/or performance of the member's
responsibilities under all financial responsibility rules promulgated
pursuant to the provisions of the Act;
     overall supervision of and responsibility for the
individuals who are involved in the administration and maintenance of
the member's back office operations; or
     any other matter involving the financial and operational
management of the member.
    NASD Rule 1022(b)(3) provides that a person registered solely as a
Financial and Operations Principal shall not be qualified to function
in a principal capacity with responsibility over any area of business
activity not described in paragraph (b)(2) of the rule.
    In consultation with a committee of industry representatives, FINRA
recently undertook a review of the Series 27 examination program. As a
result of this review, FINRA is proposing to make revisions to the
content outline to reflect changes to the laws, rules and regulations
covered by the examination and to incorporate the functions and
associated tasks currently performed by a Financial and Operations
Principal. FINRA also is proposing to make changes to the format of the
content outline.
Current Outline
    The current content outline is divided into seven sections. The
following are the seven sections and the number of questions associated
with each of the sections, denoted Section 1 through Section 7:
    1. Keeping And Preservation of Records and Broker-Dealer Financial
Reporting Requirements, 15 questions;
    2. Net Capital Requirements, 44 questions;
    3. Customer Protection, 36 questions;
    4. Municipal Securities Rulemaking Board--Regulations, 9 questions;
    5. Extensions Of Credit In The Securities Industry, 8 questions;
    6. Procedural Rules, 12 questions; and
    7. Other Relevant Regulation and Interpretations, 21 questions.
    Each section also includes the applicable laws, rules and
regulations associated with that section. The current outline also
includes a preface (addressing, among other things, the purpose,
administration and scoring of the examination), sample questions and
reference materials.

Proposed Revisions
    To develop the revised outline, FINRA conducted a job analysis
study of Financial and Operations Principals, which included the use of
a survey. The study provided detailed information regarding the day-to-
day roles, responsibilities and job functions of Financial and
Operations Principals. As a result, FINRA is proposing to revise the
structure of the outline as described below to include functions and
associated tasks that reflect the day-to-day activities of a Financial
and Operations Principal.
    Specifically, FINRA is proposing to divide the content outline into
five major job functions that are performed by a Financial and
Operations Principal. The following are the five major job functions,
denoted Function 1 through Function 5, with the associated number of
questions:
    Function 1: Financial Reporting, 25 questions;
    Function 2: Operations, General Securities Industry Regulations,
and Preservation of Books and Records, 42 questions;
    Function 3: Customer Protection, 24 questions;
    Function 4: Net Capital, 41 questions; and
    Function 5: Funding and Cash Management, 13 questions.
    As noted above, each major job function includes an assigned number
of questions. FINRA determined the number of questions for each
function based on the results of the job analysis study. Thus, compared
to the existing outline, the allocation of questions in the revised
outline more closely reflects the current day-to-day activities of a
Financial and Operations Principal.
    Each function also includes specific tasks describing activities
associated with performing that function. There are five tasks (1.1-
1.5) associated with Function 1; three tasks (2.1-2.3) associated with
Function 2; five tasks (3.1-3.5) associated with Function 3; seven
tasks (4.1-4.7) associated with Function 4; and two tasks (5.1-5.2)
associated with Function 5.\13\ By way of example, one such task (Task
2.2) is to prepare and preserve financial records to ensure accuracy
and completeness of internal financial documents.\14\ Further, the
outline lists the knowledge required to perform each function and
associated tasks (e.g., general ledger and sub-ledgers).\15\ In
addition, where applicable, the outline lists the laws, rules and
regulations a candidate is expected to know to perform each function
and associated tasks. These include the applicable FINRA Rules (e.g.,
FINRA Rule 4160), NASD Rules (e.g., NASD Rule 2340) and SEC rules
(e.g., SEA Rule 17a-4).\16\
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    \13\ See Exhibit 3a, Outline Pages 6-20. The Commission notes
that all references to Exhibit 3a refer to Exhibit 3a to the
proposed rule change.
    \14\ See Exhibit 3a, Outline Page 10.
    \15\ See Exhibit 3a, Outline Page 10.
    \16\ See Exhibit 3a, Outline Page 10.
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    As noted above, FINRA also is proposing to revise the content
outline to reflect changes to the laws, rules and regulations covered
by the examination. Among other revisions, FINRA is proposing to revise
the content outline to reflect the adoption of rules in the
consolidated FINRA rulebook (e.g., NASD Rule 2430 (Charges for Services
Performed) and NASD Rule 3110 (Books and Records) were adopted as FINRA
Rule 2122 (Charges for Services Performed) and FINRA Rule 4510 Series
(Books and Records Requirements), respectively).\17\ Further, based on
the MSRB's elimination of the Financial and Operations Principal
requirements in MSRB Rule G-3(d), the revised outline does not include
any MSRB rules.\18\
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    \17\ See Rule Conversion Chart, available at http://www.finra.org/Industry/Regulation/FINRARules/p085560.
    \18\ See Securities Exchange Act Release No. 72743 (August 1,
2014), 79 FR 46290 (August 7, 2014) (Order Approving File No. SR-
MSRB-2014-04).
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    FINRA is proposing similar changes to the Series 27 selection
specifications and question bank.
    Finally, FINRA is proposing to make changes to the format of the
content outline, including the preface, sample questions and reference
materials. Among other changes, FINRA is proposing to: (1) Add a table
of contents; \19\ (2) provide more details regarding the purpose of the
examination; \20\ (3) provide more details on the application
procedures; \21\ (4) provide more details on the development and
maintenance of the content outline and examination; \22\ (5) explain
that the passing scores are established by FINRA staff, in consultation
with a committee of industry representatives, using a standard setting
procedure and that the scores are an absolute standard independent of
the performance of candidates taking the examination; \23\ and (6) note
that each candidate will receive a score report at the end of the test
session, which will indicate a pass or fail status and include a score
profile listing the candidate's performance on each major content area
covered on the examination.\24\
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    \19\ See Exhibit 3a, Outline Page 2.
    \20\ See Exhibit 3a, Outline Page 3.
    \21\ See Exhibit 3a, Outline Page 3.
    \22\ See Exhibit 3a, Outline Page 4.
    \23\ See Exhibit 3a, Outline Page 5.
    \24\ See Exhibit 3a, Outline Page 5.
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    The number of questions on the Series 27 examination will remain at
145 scored multiple-choice questions,\25\ and candidates will continue
to have 225 minutes to complete the examination. Currently, a score of
70 percent is required to pass the examination. The passing score for
the revised Series 27 examination will be 69 percent.
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    \25\ Consistent with FINRA's practice of including ``pre-test''
questions on certain qualification examinations, which is designed
to ensure that new examination questions meet acceptable testing
standards prior to use for scoring purposes, the examination
includes ten additional, unidentified pre-test questions that do not
contribute towards the candidate's score. Therefore, the examination
actually consists of 155 questions, 145 of which are scored. The ten
pre-test questions are randomly distributed throughout the
examination.
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Availability of Content Outlines
    The current Series 27 content outline is available on FINRA's Web
site, at http://www.finra.org/industry/qualification-exams. The revised
Series 27 content outline will replace the current content outline on
FINRA's Web site.
    FINRA is filing the proposed rule change for immediate
effectiveness. FINRA proposes to implement the revised Series 27
examination program on December 14, 2015. FINRA will announce the
proposed rule change and the implementation date in a Regulatory
Notice.
2. Statutory Basis
    FINRA believes that the proposed revisions to the Series 27
examination program are consistent with the provisions of Section
15A(b)(6) of the Act,\26\ which requires, among other things, that
FINRA rules must be designed to prevent fraudulent and manipulative
acts and practices, to promote just and equitable principles of trade,
and, in general, to protect investors and the public interest, and
Section 15A(g)(3) of the Act,\27\ which authorizes FINRA to prescribe
standards of training, experience, and competence for persons
associated with FINRA members. FINRA believes that the proposed
revisions will further these purposes by updating the examination
program to reflect changes to the laws, rules and regulations covered
by the examination and to incorporate the functions and associated
tasks currently performed by a Financial and Operations Principal.
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    \26\ 15 U.S.C. 78o-3(b)(6).
    \27\ 15 U.S.C. 78o-3(g)(3).

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

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. The updated examination aligns
with the functions and associated tasks currently performed by a
Financial and Operations Principal and tests knowledge of the most
current laws, rules, regulations and skills relevant to those functions
and associated tasks. As such, the proposed revisions would make the
examination more efficient and effective.

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \28\ and paragraph (f)(1) of Rule 19b-4
thereunder.\29\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act. If
the Commission takes such action, the Commission shall institute
proceedings to determine whether the proposed rule should be approved
or disapproved.
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    \28\ 15 U.S.C. 78s(b)(3)(A).
    \29\ 17 CFR 240.19b-4(f)(1).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2015-038 on the subject line.

Paper Comments

     Send paper comments in triplicate to Robert W. Errett,
Deputy Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-FINRA-2015-038. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of FINRA. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-FINRA-2015-038 and should be
submitted on or before November 13, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\30\
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    \30\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-26913 Filed 10-22-15; 8:45 am]
 BILLING CODE 8011-01-P


FILE NAME:  Valent.doc (Aug 9 , 2011)

EPA Registration Division contact: Venus Eagle<PHONE_NUMBER>)

[Insert Petition Number] amend 40 CFR

Summary of Petition

EPA has received a pesticide petition (Insert Petition Number) from
Interregional Research Project Number 4 (IR-4), IR-4 Project
Headquarters, Rutgers, The State University of New Jersey, 500 College
Road East, Suite 201 W, Princeton, NJ  08450   SEQ CHAPTER \h \r 1  ,
proposing, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.586
(a), by establishing  tolerances for residues of the insecticide
chemical clothianidin,
(E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or
on the following agricultural commodities:

Commodity	Proposed Tolerance

Parts per million

(For parent only unless indicated otherwise)

Strawberry 	1.4 ppm

Citrus Fruit Group  ( 10-10) 	0.5 ppm

Citrus Pulp 	1 ppm

Pistachio 	0.01 ppm

Tea 	50 ppm

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

A. Residue Chemistry

1. Plant metabolism. The metabolism of clothianidin is adequately
understood for the purpose of granting the proposed tolerances.

2.  Analytical method.  Adequate enforcement methodology (liquid
chromatography/mass spectroscopy/mass spectroscopy, LC/MS/MS analysis)
is available to enforce the tolerance expression.

3. Magnitude of residues.  .

 Residue data on strawberry and the representative crops of citrus fruit
crop grouping (grapefruit, lemon and orange) has been submitted which
adequately support the requested tolerances. Pistachio petition will be
supported by the existing tolerance for tree nuts (Crop Group 14) of
0.01 ppm.

B. Toxicological Profile

A complete, valid and reliable database of mammalian and genetic
toxicology studies has been submitted to EPA that supports the proposed
tolerances for clothianidin. The nature of the toxic effects caused by
clothianidin, as well as the no observed adverse effect level (NOAEL)
and the lowest observed adverse effect level (LOAEL) from the toxicity
studies reviewed, are discussed in the Federal Register of May 30, 2003
(68 FR 32390) (FRL-7306-8)
[http://www.epa.gov/EPA-PEST/2003/May/Day-30/p13564.htm and in the HED
memorandum dated 8/13/2009 from Dr. Michael Doherty to Kable Davis/Venus
Eagle “Clothianidin: Human Health Risk Assessment for Proposed Uses on
Berries (Group 13-07H), Brassica Vegetables (Group 5), Cotton, Cucurbit
Vegetables

(Group 9), Fig, Fruiting Vegetables (Group 8), Leafy Green Vegetables
(Group 4A), Peach, Pomegranate, Soybean, Tree Nuts (Group 14), and
Tuberous and Corm Vegetables (Group 1C). PC Code: 044309” (DP
Barcodes: D355373, D362354).

 C. Aggregate Exposure and Risk Assessment

 i. Dietary Exposure.  Dietary exposure (food and water) assessments
were conducted to evaluate the potential risk due to acute and chronic
dietary exposure of the U.S. population and various subgroups to
combined residues of clothianidin and its metabolite TMG plus residues
of clothianidin resulting from the use of thiamethoxam.  Residues were
included from the use of clothianidin or thiamethoxam on all existing
uses and newly proposed uses including rice, citrus fruits and
strawberries.  Residues from use of clothianidin on pistachio and tea
were not included in the current assessment because the contribution to
the overall aggregate exposure is considered negligible.  These minor
crop residues will be included in the aggregate exposure assessment at
a later date.

The Cumulative and Aggregate Risk Evaluation System (CARES) Version 3.0b
was used to conduct these assessments using a combination (when
available) of actual or generated residue data, experimentally obtained
processing factors, and an estimation of percent crop treated.  Default
factors or tolerance level residues were used when experimentally
determined data were not available.

Dietary exposure from drinking water was estimated using a Tier II
PRZM/EXAMS assessment to determine the EDWCs in the Standard Index
Reservoir associated with clothianidin uses.  A 30-year daily
concentration time series data set generated from the scenario with the
maximum (worst case) EDWS estimates was then imported into CARES Water
module in order to calculate acute and chronic drinking water and
aggregate risks.

ii. Non-Dietary Exposure – residential/recreational turf.  Non-dietary
exposure to clothianidin from residential or recreational (turf grass)
application scenarios was assessed using conservative residential adult
applicator and post-application assumptions using the CARES Residential
Module.

iii. Aggregate Assessment of Risks.  The aggregate acute and chronic
risk assessment includes food, water and residential exposures.
Inclusion of chronic exposure scenarios for residential uses is a very
conservative approach since the non-dietary turf related exposure does
not represent chronic exposure risk based on the limited annual
application rate.

For acute risk assessment scenarios, the acute population adjusted dose
(aPAD) of 0.25 mg/kg was used to assess risks from acute dietary
exposure to the general population and to various sub-populations.  The
aPAD is based on the NOAEL of 25 mg/kg/day from an acute neurotoxicity
study (general population) or a developmental toxicity study (females
13-49 years of age) with an FQPA safety factor of 1.  For the acute risk
assessment, the maximum aggregate risk from food, water and residential
uses is 6% of the aPAD in infants 0 years of age (0 to 1 years).

For chronic risk assessment scenarios, the chronic population adjusted
dose (cPAD) used for the U.S. population and all subpopulations is 0.098
mg/kg/day based on a 2-generation reproduction study NOAEL of 9.8
mg/kg/day and an FQPA safety factor of 1.  For the chronic risk
assessment, the maximum aggregate risk from food and water is 3.2% of
the cPAD in infants 0 years of age (0 to 1 years).

Based on these risk assessments, the margins of exposure (MOE) for all
routes of exposure and all population subgroups exceed 100 and therefore
do not exceed EPA’s level of concern.

D. Cumulative Effects.  Section 408(b) (2) (D) (v) requires that the
Agency must consider available information concerning the cumulative
effects of a particular pesticide's residues and other substances that
have a common mechanism of toxicity. Clothianidin is a member of the
neonicotinoid class of pesticides and is a metabolite of thiamethoxam.
Structural similarities or common effects do not constitute a common
mechanism of toxicity and there is currently no evidence that
neonicotinoids share a common mechanism of toxicity.  For purposes of
this petition, clothianidin residues from use of clothianidin and
thiamethoxam have been considered.

E. Safety Determination.  The toxicological database for clothianidin is
complete.  The available data indicate that there are no consistent
specific target organs in mammals.  Based on the completeness of the
database and the observed effects, the FQPA Safety Factor has been
reduced to 1X, leaving a 100X safety factor to account for
within-species (10X) and across-species (10X) variability.  Clothianidin
has been classified as not likely to be carcinogenic to humans.

The results of the aggregate exposure risk assessment indicate the
MOE’s do not exceed EPA’s level of concern.  There is therefore a
reasonable certainty that no harm will result to the general population
or to any population subgroup, including infants and children, resulting
from aggregate exposure to residues of clothianidin.

F. International Tolerances   Canadian maximum residue limits (MRL) have
been established for residues of clothianidin at 0.01 milligram/kilogram
(mg/kg) in milk, corn, canola, stone fruits, grape, potato and pome
fruits. Clothianidin is being evaluated by the JMPR and there are no
Codex Maximum Residue Limits (MRL) established.


[Federal Register Volume 86, Number 108 (Tuesday, June 8, 2021)]
[Notices]
[Page 30513]
[FR Doc No: 2021-11980]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2021-0493]

Agency Information Collection Activities: Requests for Comments;
Clearance of a Renewed Approval of Information Collection: Part 121
Operating Requirements: Domestic, Flag, and Supplemental Operations

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

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The collection involves regulations that prescribe the
requirements governing air carrier operations. The information
collected is necessary to determine air operators' compliance with the
minimum safety standards and the applicants' eligibility for air
operations certification.

DATES: Written comments should be submitted by August 9, 2021.

ADDRESSES: Please send written comments:
    By Electronic Docket: https://www.regulations.gov (Enter docket
number into search field).
    By Mail: Sandra Ray, Federal Aviation Administration, Policy
Integration Branch AFS-270, 1187 Thorn Run Road, Suite 200, Coraopolis,
PA 15108.
    By Fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Sandra Ray by email at:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-0008.
    Title: Part 121 Operating Requirements: Domestic, Flag, and
Supplemental Operations.
    Form Numbers: None.
    Type of Review: Renewal of an information collection.
    Background: Under the authority of Title 49 CFR, Section 44701,
Title 14 CFR prescribes the terms, conditions, and limitations as are
necessary to ensure safety in air transportation. Title 14 CFR part 121
prescribes the requirements governing air carrier operations. The
information collected is used to determine air operators' compliance
with the minimum safety standards and the applicants' eligibility for
air operations certification. Each operator which seeks to obtain, or
is in possession of an air carrier operating certificate, must comply
with the requirements of part 121 which include maintaining data which
is used to determine if the air carrier is operating in accordance with
minimum safety standards.
    Respondents: 66 Part 121 Air Carriers.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: Varies per Response and
Requirement type.
    Estimated Total Annual Burden: 1,455,260 Hours.

    Issued in Washington, DC, on June 3, 2021.
Sandra L. Ray,
Aviation Safety Inspector, AFS-270.
[FR Doc. 2021-11980 Filed 6-7-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 73 (Monday, April 19, 2021)]
[Rules and Regulations]
[Pages 20278-20284]
[FR Doc No: 2021-07860]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 862, 866, 880, 884 and 892

[Docket No. FDA-2018-N-1440]
RIN 0910-AH67

Medical Devices; Medical Device Classification Regulations To
Conform to Medical Software Provisions in the 21st Century Cures Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY:  The Food and Drug Administration (FDA, Agency, or we) is
amending certain classification regulations to reflect changes to the
Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the 21st
Century Cures Act (the Cures Act). The Cures Act amended the definition
of a device in the FD&C Act to exclude certain software functions. FDA
is taking this action so that its regulations conform to the medical
software provisions in the Cures Act.

DATES: This rule is effective on April 19, 2021.

FOR FURTHER INFORMATION CONTACT: Bakul Patel, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5528, Silver Spring, MD 20993,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
II. Table of Abbreviations and Acronyms Commonly Used in This
Document
III. Background
IV. Legal Authority
V. Description of the Final Rule
    A. Scope
    B. Calculator/Data Processing Module for Clinical Use
    C. Continuous Glucose Monitor Secondary Display
    D. Automated Indirect Immunofluorescence Microscope and
Software-Assisted System
    E. Medical Device Data Systems
    F. Home Uterine Activity Monitor
    G. Medical Image Storage Device
    H. Medical Image Communications Device
    I. Picture Archiving and Communications System
VI. Effective Date
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. Reference

I. Executive Summary

A. Purpose of the Final Rule

    On December 13, 2016, the Cures Act was enacted (Pub. L. 114-255).
The Cures Act amended the FD&C Act to include descriptions of software
functions that are excluded from the definition of device in the FD&C
Act. The Cures Act amended the FD&C Act to state that the term device
does not include the software functions excluded pursuant to section
520(o)(1) of the FD&C Act.
    Among the software functions excluded from the definition of device
by this provision, most relevant to this rule are the software
functions intended to transfer, store, convert formats, or display
clinical laboratory test or other device data, results, and findings
and that do not interpret or analyze such clinical laboratory test or
other device data, results, and findings. Because the provision only
excludes certain software functions from the device definition, the
regulatory status of device hardware remains unchanged. With this final
rule, FDA is amending the ``identification'' description of eight
classification regulations so that the regulations no longer include
software functions that the Cures Act excluded from the device
definition in the FD&C Act. In other words, in this action, FDA is
amending eight classification regulations so that the regulations
conform to the medical software provisions of the Cures Act and reflect
FDA's current statutory authority.

B. Summary of the Major Provisions of the Final Rule

    This rule updates eight classification regulations by amending
these regulations to exclude software functions that no longer fall
within the device definition under 201(h) of the FD&C Act.
Specifically, FDA is amending the following classification regulations:
     Amend the calculator/data processing module for clinical
use ``identification'' description to remove non-device software
functions that maintain and retrieve laboratory data;
     amend the continuous glucose monitor (CGM) secondary
display ``identification'' description to remove receive and display
software functions, and amend the title of the CGM secondary display
regulation to

``Continuous Glucose Monitor (CGM) Secondary Alarm System;''
     amend the automated indirect immunofluorescence microscope
and software-assisted system device ``identification'' description by
replacing the first use of the word ``software'' with ``device''
because both hardware and software functions that use fluorescent
signal acquisition and processing software, data storage, and
transferring mechanisms, or assay specific algorithms to interpret or
analyze results, are devices;
     amend the medical device data systems (MDDS)
``identification'' description to remove non-device software functions
intended for transferring, storing, converting formats, or displaying
clinical laboratory test or other device data and results;
     amend the home uterine activity monitor (HUAM)
``identification'' description to remove non-device software functions
intended for transmitting, receiving, and displaying data;
     amend medical image storage device ``identification''
description to remove non-device software functions intended for
storing and retrieving so that a medical image storage device is a
hardware device that provides electronic storage and retrieval
functions for medical images;
     amend medical image communications device
``identification'' description to include software functions intended
for medical image processing and manipulation; and
     amend picture archiving and communications system
``identification'' description to remove non-device software functions
intended for storing and displaying medical images, revise the
``identification'' description to clarify that the regulation includes
software and hardware functions intended for medical image management
and processing, and revise the title of the classification regulation
to ``Medical Image Management and Processing System.''
    This final rule does not change the classification of the device
types for which FDA is amending the title and/or identification
statements. This rule will ensure that the specific classification
regulations conform to changes the Cures Act made to the FD&C Act and
reflect current FDA statutory authority.

C. Legal Authority

    This final rule is being issued under sections 201(h), 520(o), and
701 of the FD&C Act (21 U.S.C. 321, 360j, and 371) and the device and
general administrative provisions of the FD&C Act sections 501, 510,
513, 515, 520, 522, and 701 (21 U.S.C. 351, 360, 360c, 360e, 360j,
360l, and 371).

II. Table of Abbreviations and Acronyms Commonly Used in This Document

----------------------------------------------------------------------------------------------------------------
       Abbreviation or acronym                                       What it means
----------------------------------------------------------------------------------------------------------------
510(k)..............................  Premarket Notification.
APA.................................  Administrative Procedure Act.
CFR.................................  Code of Federal Regulations.
CGM.................................  Continuous Glucose Monitor.
Cures Act...........................  21st Century Cures Act.
E.O.................................  Executive Order.
FDA or the Agency...................  Food and Drug Administration.
FD&C Act............................  Federal Food, Drug, and Cosmetic Act.
HUAM................................  Home Uterine Activity Monitor.
IMACS...............................  Image Management and Communications Systems.
MDDS................................  Medical Device Data System.
PACS................................  Picture Archiving and Communications System.
U.S.C...............................  United States Code.
----------------------------------------------------------------------------------------------------------------

III. Background

    On December 13, 2016, the Cures Act was enacted. The Cures Act
amended, among other things, FDA's authority to regulate medical
software, including certain clinical decision support software. The
provision of the Cures Act entitled ``Clarifying Medical Software
Regulation,'' amended section 520 of the FD&C Act by adding subsection
(o), which describes specific software functions that are excluded from
the definition of device in the FD&C Act (section 201(h) of FD&C Act).
    Section 520(o)(1) of the FD&C Act excludes from the definition of
device software functions that are intended for:
    1. Administrative support of a healthcare facility (section
520(o)(1)(A));
    2. Maintaining or encouraging a healthy lifestyle and unrelated to
the diagnosis, cure, mitigation, prevention, or treatment of a disease
or condition (section 520(o)(1)(B));
    3. Serving as electronic patient records, including patient-
provided information, to the extent that such records are intended to
transfer, store, convert formats, or display the equivalent of a paper
medical chart, so long as such records were created, stored,
transferred, or reviewed by healthcare professionals or by individuals
working under supervision of such professionals; such records are part
of health information technology that is certified under section
3001(c)(5) of the Public Health Service Act (42 U.S.C. 300jj-11(c)(5));
and such function is not intended to interpret or analyze patient
records, including medical image data, for the purpose of diagnosis,
cure, mitigation, prevention, or treatment of a disease or condition
(section 520(o)(1)(C)); or
    4. Transferring, storing, converting formats, or displaying
clinical laboratory test or other device data and results, findings by
a healthcare professional with respect to such data and results, unless
such function is intended to interpret or analyze clinical laboratory
test or other device data, results, or findings (section 520(o)(1)(D));
or
    5. Unless the function is intended to acquire, process, or analyze
a medical image or a signal from an in vitro diagnostic device or a
pattern or signal from a signal acquisition system, for the purpose
of--(section 520(o)(1)(E));
    a. Displaying, analyzing, or printing medical information about a
patient or other medical information (such as peer-reviewed clinical
studies and clinical practice guidelines) (section 520(o)(1)(E)(i));
    b. Supporting or providing recommendations to a healthcare
professional about prevention, diagnosis, or treatment of a disease or
condition (section 520(o)(1)(E)(ii)); and
    c. Enabling such healthcare professional to independently review
the basis for such recommendations that such software presents so that
it is not the intent that such healthcare professional rely primarily
on any of

such recommendations to make a clinical diagnosis or treatment decision
regarding an individual patient (section 520(o)(1)(E)(iii)).
    The Cures Act also provides that a software function described in
section 520(o)(1)(C), (D), or (E) of the FD&C Act will not be excluded
from the device definition under section 201(h) of the FD&C Act if FDA
makes a finding that the software function would be reasonably likely
to have serious adverse health consequences and certain substantive and
procedural criteria are met (section 520(o)(3) of the FD&C Act). Also,
nothing in section 520(o)(1) should exclude regulated software used in
the manufacture and transfusion of blood and blood components to assist
in the prevention of disease in humans (section 520(o)(4) of the FD&C
Act).
    A device, as defined in section 201(h) of the FD&C Act, may be
comprised of one or more functions that are subject to FDA oversight.
FDA defines the term ``function'' as a distinct purpose of a product,
which could be the intended use or a subset of the intended use of the
product and is not synonymous with the term ``device.'' For example, a
device with an intended use to analyze data has one function: Analysis.
A device with an intended use to store, transfer, and analyze data has
three functions: (1) Storage, (2) transfer, and (3) analysis. Devices
with ``multiple functions'' may contain functions that are software
functions excluded from the device definition as described in section
520(o) of the FD&C Act.
    FDA is issuing this final rule because the FD&C Act was amended by
the Cures Act to remove certain software functions from the device
definition, including software functions that are solely intended to
transfer, store, convert formats, or display medical device data and
results, including medical images or other clinical information, unless
such functions are intended to interpret or analyze clinical laboratory
test or other device data, results, and findings (sections 201(h) and
520(o)(1)(D) of the FD&C Act).
    FDA is making its regulations consistent with the FD&C Act as
amended by the Cures Act by amending the ``identification''
descriptions in eight regulations so that the descriptions do not
include software functions that no longer fall within the definition of
a device. The Agency has conducted a detailed review of all device
classification regulations to determine whether the classification
regulations contain software functions identified under section
520(o)(1)(A)-(E) of the FD&C Act (see 21 CFR parts 862-892), and
therefore should be amended to reflect changes the Cures Act made to
FDA's device statutory authority. As a result of this review, FDA
identified eight classification regulations to amend (see Table 1
below).
    Because of changes made to the FD&C Act by the Cures Act, the
``identification'' description of certain classification regulations
that predated the Cures Act are no longer consistent with the FD&C Act.
FDA finds good cause for issuing this amendment as a final rule without
notice and comment because this rule only updates the
``identification'' description of those classification regulations so
they reflect changes made to the FD&C Act by the Cures Act (see section
520(o)(1) of the FD&C Act) (5 U.S.C. 553(b)(3)(B)). In addition, FDA
also finds good cause for this amendment to become effective on the
date of publication of this action. The Administrative Procedure Act
(APA) allows an effective date less than 30 days after publication as
``provided by the agency for good cause found and published with the
rule'' (5 U.S.C. 553(d)(3)). A delayed effective date is unnecessary in
this case because these amendments reflect the state of the law in
section 520(o)(1) of the FD&C Act as amended by section 3060 of the
Cures Act. This rule does not impose any new regulatory requirements on
affected parties. As a result, affected parties do not need time to
prepare before the rule takes effect. Therefore, FDA finds good cause
for these amendments to become effective on the date of publication of
this action.

IV. Legal Authority

    This final rule is being issued under sections 201(h), 520(o), and
701 of the FD&C Act and the device and general administrative
provisions of the FD&C Act sections 501, 510, 513, 515, 520, 522, and
701.

V. Description of the Final Rule

A. Scope

    FDA is amending the ``identification'' description in eight
classification regulations, so that they no longer include software
functions that are excluded from the device definition by section
520(o)(1) of the FD&C Act and thus are not subject to FDA's device
statutory authority. Among the software functions excluded from the
definition of device in the FD&C Act, most relevant to this rule are
the software functions excluded by section 520(o)(1)(D) of the FD&C
Act. This provision excludes software functions that are solely
intended to transfer, store, convert formats, or display, unless such
functions are intended to interpret or analyze clinical laboratory test
or other device data, results, and findings. This includes functions
that are intended for data retrieval, receipt, or transmission because
these are forms of information ``transfer,'' and functions that are
intended for data maintenance, which is a form of ``storage'' (section
520(o)(1)(D) of the FD&C Act; see also FDA guidance ``Changes to
Existing Medical Software Policies Resulting from Section 3060 of the
21st Century Cures Act'' (Ref. 1)). However, software functions that
analyze or interpret medical device data in addition to transferring,
storing, converting formats, or displaying clinical laboratory test or
other device data and results remain subject to FDA's regulatory
oversight, unless they fall within section 520(o)(1)(E) of the FD&C
Act, which excludes certain clinical decision support software
functions from the device definition.
    Section 520(o)(1) of the FD&C Act describes software functions, not
hardware functions, that are excluded from the definition of a device.
Therefore, device hardware that is specifically intended to transfer,
store, convert formats, and display medical device data and results
(such as electrical hardware, magnetic and optical discs, physical
communications medium, etc.) remains a device.
    In Table 1, we list the regulations that FDA is amending to conform
the ``identification'' description with the device definition under the
FD&C Act. The amendments to the ``identification'' description of these
regulations do not affect the classification of the devices in this
final rule (i.e., the device types remain class I, class II, etc.).

             Table 1--Classification Regulations Amendments
------------------------------------------------------------------------
                                        Device type (existing product
Classification regulation (21 CFR)                code(s))
------------------------------------------------------------------------
862.2100..........................  Calculator/Data Processing Module
                                     for Clinical Use (JQP, NVV).

862.1350..........................  Continuous Glucose Monitor Secondary
                                     Display (PJT, PKU).
866.4750..........................  Automated Indirect
                                     Immunofluorescence Microscope and
                                     Software-Assisted System (PIV).
880.6310..........................  Medical Device Data System (OUG).
884.2730..........................  Home Uterine Activity Monitor (LQK,
                                     MOH).
892.2010..........................  Medical Image Storage Device (LMB,
                                     NFF).
892.2020..........................  Medical Image Communications Device
                                     (NFG, LMD).
892.2050..........................  Picture Archiving and Communications
                                     System (QIH, OMJ, NWE, PGY, OEB,
                                     QKB, PZO, NFJ, LLZ).
------------------------------------------------------------------------

B. Calculator/Data Processing Module for Clinical Use

    A calculator/data processing module for clinical use is an
electronic device intended to store, retrieve, and process laboratory
data (21 CFR 862.2100). Because ``storing and retrieving data'' are
software functions that no longer fall within the definition of a
device, FDA is amending the classification regulation to remove the
language ``store, retrieve, and'' so that the regulation will state:
``a calculator/data processing module for clinical use is an electronic
device intended to process laboratory data.''

C. Continuous Glucose Monitor Secondary Display

    A CGM secondary display is identified as a device intended to be
used for passive real-time monitoring of continuous glucose monitoring
data Sec.  862.1350 (21 CFR 862.1350). The identification further
describes that the primary display device, which is not a part of the
CGM secondary display, directly receives the glucose data (for example,
it communicates directly with transmitter) from the continuous glucose
meter, which is not a part of the continuous glucose monitor secondary
display, and is the primary means of viewing the continuous glucose
monitor data and alerting the patient to a low or high glucose value. A
continuous glucose monitor secondary display can be used by caregivers
of people with diabetes to monitor a person's continuous glucose
monitoring data.
    The intended use of the device, as explained in FDA's 2015 Dexcom
Share Direct Secondary Displays (DEN140038) order, includes the
functions to receive and display medical device data (i.e., real-time
glucose values and glucose trend information), in addition to functions
to receive and deliver notifications and alarms. Because of changes
made to the FD&C Act by the Cures Act, receiving and displaying device
data software functions are no longer device functions. To make this
regulation consistent with the FD&C Act, therefore, FDA is amending the
title of the classification in Sec.  862.1350 to ``continuous glucose
monitor secondary alarm system'' and is amending the ``identification''
description to state that ``a continuous glucose monitor (CGM)
secondary alarm system is identified as a device intended to be used as
a secondary alarm for a CGM to enable immediate awareness for potential
clinical intervention to help assure patient safety.'' With these
amendments, the regulation no longer includes software functions
excluded by the Cures Act, i.e., functions to receive and display
medical device data.

D. Automated Indirect Immunofluorescence Microscope and Software-
Assisted System

    An automated indirect immunofluorescence microscope and software-
assisted system is a device that acquires, analyzes, stores, and
displays digital images of indirect immunofluorescent slides (21 CFR
866.4750). FDA is replacing the first occurrence of the word
``software'' with ``device'' in the identification section, so that the
identification will state that the device may use fluorescent signal
acquisition and processing software, data storage and transferring
mechanisms, or assay specific algorithms to suggest results. Because
some of the software functions included in the regulation remain within
the device definition (e.g., assay specific algorithms to suggest
results), the ``identification'' description will not be limited to
hardware functions only. Instead, FDA is using the term ``device,''
which includes software functions that continue to fall within the
device definition and hardware functions.

E. Medical Device Data System

    An MDDS is intended to provide one or more of the following uses,
without controlling or altering the functions or parameters of any
connected medical devices: (1) The electronic transfer of medical
device data; (2) the electronic storage of medical device data; (3) the
electronic conversion of medical device data from one format to another
format in accordance with a preset specification; or (4) the electronic
display of medical device data (Sec.  880.6310 (21 CFR 880.6310)). An
MDDS may include software, electronic or electrical hardware such as a
physical communications medium (including wireless hardware), modems,
interfaces, and a communications protocol. Each MDDS function ((1)-(4))
describes a software function that is excluded from the device
definition under section 520(o)(1)(D) of the FD&C Act. Thus, FDA is
amending the regulation to state that only hardware that performs these
functions remain within the definition of devices by adding the term
``hardware'' to the ``identification'' description so that the
regulation (Sec.  880.6310(a)(1)) states that an MDDS is a ``hardware
device that is intended to provide one or more of the following uses .
. .''.
    In addition, FDA is amending Sec.  880.6310(a)(2) to remove the
term ``software,'' because the software functions described in the
identification of Sec.  880.6310(a)(2) no longer fall within the
definition of a device. Further, FDA is removing the phrase ``a
communications protocol'' from Sec.  880.6310(a)(2), because the term
``communications protocol'' refers to software functions associated
with the transfer of data, and this function does not fall within the
definition of a device. FDA is also amending the identification of
Sec.  880.6310(a)(2) to include the term ``hardware,'' such that the
``identification'' description states that MDDS ``does not include
hardware devices intended to be used in connection with active patient
monitoring.'' FDA is revising this identification because hardware
devices for active patient monitoring are classified under other
regulations for software- and hardware-based devices, and are not
included in this regulation. The identification of Sec.  880.6310(a)(2)
will be amended to include the following: ``Hardware devices for active
patient monitoring are classified under other regulations and are not
included in this regulation.''

F. Home Uterine Activity Monitor

    A HUAM is an electronic system for at home antepartum measurement
of uterine contractions, data transmission by telephone to a clinical
setting, and for receipt and display of the uterine contraction data at
the clinic (21 CFR 884.2730). The HUAM system comprises a
tocotransducer, an at-home recorder, a modem, and a computer and
monitor that receive, process, and display data. This device is
intended for use in women with a previous preterm delivery to aid in
the detection of preterm labor. The identification in the
classification regulation for this device includes software functions
intended to transmit, receive, and display data, which no longer fall
within the statutory definition of a device. Therefore, FDA is removing
these software functions from the ``identification'' description in
this classification regulation.

G. Medical Image Storage Device

    A medical image storage device is a device that provides electronic
storage and retrieval functions for medical images and may employ
software, electronic, or electrical hardware such as magnetic and
optical discs, magnetic tape, and digital memory (Sec.  892.2010 (21
CFR 892.2010)). Medical image storage includes software functions,
specifically storage and retrieval functions, which are excluded from
the device definition by section 520(o)(1)(D) of the FD&C Act. Thus,
FDA is amending the regulation to state that only hardware that
performs these functions remains within the device definition so that
the regulation (Sec.  892.2010(a)(1)) states that a medical image
storage device is a ``hardware device that is intended to provide for
the electronic storage and retrieval functions for medical images.''

H. Medical Image Communications Device

    A medical image communications device provides electronic transfer
of medical image data between medical devices (21 CFR 892.2020). The
device may include a physical communications medium, modems, or
interfaces. In reviewing this classification regulation, FDA has
determined that products with specific software functions for medical
image processing and manipulation should be mentioned in the
``identification'' description of the classification regulation because
such functions have always been included in the regulation and are not
excluded under section 520(o)(1)(D) of the FD&C Act. Therefore, FDA is
amending this regulation to include the following clarifying language
to the ``identification'' description: ``It may provide simple image
review software functionality for medical image processing and
manipulation, such as grayscale window and level, zoom and pan, user
delineated geometric measurements, compression, or user added image
annotations. The device does not perform advanced image processing or
complex quantitative functions. This does not include electronic
transfer of medical image software functions.''

I. Picture Archiving and Communications System

    The Picture Archiving and Communications Systems (PACS) device
includes both software and hardware image storage and display functions
and software image processing functions (21 CFR 892.2050). FDA has
determined that software functions in the PACS classification
regulation for storage and display of medical images no longer fall
within the definition of a device under section 520(o)(1)(D) of the
FD&C Act. However, FDA recognizes that some software functions in the
PACS regulation, which are for complex image processing, including
those for image manipulation, enhancement, or quantification, remain
device functions. Therefore, FDA is amending this regulation to change
the title of the classification regulation from ``Picture Archiving and
Communications Systems'' to ``Medical Image Management and Processing
System'' and is amending the ``identification'' description to exclude
software functions for the ``storage and display'' of medical images.
In addition, the amendment to the PACS classification regulation
clarifies specific functions and the device's intended use with
examples in the ``identification'' description.

VI. Effective Date

    This final rule is effective on the date of publication in the
Federal Register.

VII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under E.O. 12866,
E.O. 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). E.O.s 12866 and
13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Because this final rule
merely amends certain classification regulations to remove provisions
that are now obsolete in order to conform to the medical software
provisions in the Cures Act, it does not impose any additional
regulatory burdens. Therefore, we believe that this final rule is not
economically significant and not a significant regulatory action as
defined by E.O. 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this regulation does not change requirements, and
amends certain classification regulations to conform to the medical
software provisions in the Cures Act, we certify that the final rule
will not have a significant economic impact on a substantial number of
small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $158
million, using the most current (2020) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.
    Because this direct final rule does not impose any additional
regulatory burdens, this regulation is not anticipated to result in any
compliance costs.

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(i) and 25.34(b) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

IX. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

X. Federalism

    We have analyzed this rule in accordance with the principles set
forth in E.O. 13132. We have determined that this rule does not contain
policies that

have substantial direct effects on the States, on the relationship
between the National Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
Accordingly, we conclude that the rule does not contain policies that
have federalism implications as defined in the E.O. and, consequently,
a federalism summary impact statement is not required.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set
forth in E.O. 13175. We have determined that the rule does not contain
policies that have substantial direct effects on one or more Indian
Tribes, on the relationship between the Federal Government and Indian
Tribes, or on the distribution of power and responsibilities between
the Federal Government and Indian Tribes. Accordingly, we conclude that
the rule does not contain policies that have tribal implications as
defined in the E.O. and, consequently, a tribal summary impact
statement is not required.

XII. Reference

    The following reference is on display in the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.

    1. FDA Guidance, Changes to Existing Medical Software Policies
Resulting from Section 3060 of the 21st Century Cures Act, available
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/changes-existing-medical-software-policies-resulting-section-3060-21st-century-cures-act.

List of Subjects

21 CFR Part 862

    Medical devices.

21 CFR Part 866

    Biologics, Laboratories, Medical devices.

21 CFR Part 880

    Medical devices.

21 CFR Part 884

    Medical devices.

21 CFR Part 892

    Medical devices, Radiation protection, and X-rays.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, 21 CFR
parts 862, 866, 880, 884, and 892 are amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

0
1. The authority citation for part 862 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Amend Sec.  862.1350 by revising the section heading and paragraph
(a) to read as follows:

Sec.  862.1350   Continuous glucose monitor secondary alarm system.

    (a) Identification. A continuous glucose monitor (CGM) secondary
alarm system is identified as a device intended to be used as a
secondary alarm for a CGM to enable immediate awareness for potential
clinical intervention to help assure patient safety.
* * * * *

0
3. Amend Sec.  862.2100 by revising paragraph (a) to read as follows:

Sec.  862.2100   Calculator/data processing module for clinical use.

    (a) Identification. A calculator/data processing module for
clinical use is an electronic device intended to process laboratory
data.
* * * * *

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
4. The authority citation for part 866 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
5. Amend Sec.  866.4750 by revising paragraph (a) to read as follows:

Sec.  866.4750   Automated indirect immunofluorescence microscope and
software-assisted system.

    (a) Identification. An automated indirect immunofluorescence
microscope and software assisted system is a device that acquires,
analyzes, stores, and displays digital images of indirect
immunofluorescent slides. It is intended to be used as an aid in the
determination of antibody status in clinical samples. The device may
include a fluorescence microscope with light source, a motorized
microscope stage, dedicated instrument controls, a camera, a computer,
a sample processor, or other hardware components. The device may use
fluorescent signal acquisition and processing software, data storage
and transferring mechanisms, or assay specific algorithms to suggest
results. A trained operator must confirm results generated with the
device.
* * * * *

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

0
6. The authority citation for part 880 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
7. Amend Sec.  880.6310 by revising paragraph (a) to read as follows:

Sec.  880.6310   Medical device data system.

    (a) Identification. (1) A medical device data system (MDDS) is a
hardware device that is intended to provide one or more of the
following uses, without controlling or altering the functions or
parameters of any connected medical devices:
    (i) The electronic transfer of medical device data;
    (ii) The electronic storage of medical device data;
    (iii) The electronic conversion of medical device data from one
format to another format in accordance with a preset specification; or
    (iv) The electronic display of medical device data.
    (2) An MDDS may include electronic or electrical hardware such as a
physical communications medium (including wireless hardware), modems,
and interfaces. This identification does not include hardware devices
intended to be used in connection with active patient monitoring.
Hardware devices for active patient monitoring are classified under
other regulations and are not included in this regulation.
* * * * *

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

0
8. The authority citation for part 884 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
9. Amend Sec.  884.2730 by revising paragraph (a) to read as follows:

Sec.  884.2730   Home uterine activity monitor.

    (a) Identification. A home uterine activity monitor (HUAM) is an
electronic system for at home antepartum measurement of uterine
contractions. The HUAM system comprises a tocotransducer and an at-home
recorder. This device is intended for use in women with a previous
preterm delivery to aid in the detection of preterm labor.
* * * * *

PART 892--RADIOLOGY DEVICES

0
10. The authority citation for part 892 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
11. Amend Sec.  892.2010 by revising paragraph (a) to read as follows:

Sec.  892.2010   Medical image storage device.

    (a) Identification: A medical image storage device is a hardware
device that provides electronic storage and retrieval functions for
medical images. Examples include electronic hardware devices employing
magnetic and optical discs, magnetic tapes, and digital memory.
* * * * *

0
12. Amend Sec.  892.2020 by revising paragraph (a) to read as follows:

Sec.  892.2020   Medical image communications device.

    (a) Identification. A medical image communications device provides
electronic transfer of medical image data between medical devices. It
may include a physical communications medium, modems, and interfaces.
It may provide simple image review software functionality for medical
image processing and manipulation, such as grayscale window and level,
zoom and pan, user delineated geometric measurements, compression, or
user added image annotations. The device does not perform advanced
image processing or complex quantitative functions. This does not
include electronic transfer of medical image software functions.
* * * * *

0
13. Amend Sec.  892.2050 by revising the section heading and paragraph
(a) to read as follows:

Sec.  892.2050   Medical image management and processing system.

    (a) Identification. A medical image management and processing
system is a device that provides one or more capabilities relating to
the review and digital processing of medical images for the purposes of
interpretation by a trained practitioner of disease detection,
diagnosis, or patient management. The software components may provide
advanced or complex image processing functions for image manipulation,
enhancement, or quantification that are intended for use in the
interpretation and analysis of medical images. Advanced image
manipulation functions may include image segmentation, multimodality
image registration, or 3D visualization. Complex quantitative functions
may include semi-automated measurements or time-series measurements.
* * * * *

    Dated: April 8, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
    Dated: April 13, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-07860 Filed 4-16-21; 8:45 am]
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[Federal Register: September 21, 2007 (Volume 72, Number 183)]
[Notices]
[Page 54034-54036]
[DOCID:fr21se07-86]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2007-0272; FRL-8144-2]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Correction of Misreported Chemical Substances on the
Toxic Substances Control Act Chemical Substance Inventory; EPA ICR No.
1741.05, OMB Control No. 2070-0145

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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

SUMMARY:  In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection

Request (ICR) to the Office of Management and Budget (OMB). This ICR,
entitled: ``Correction of Misreported Chemical Substances on the Toxic
Substances Control Act (TSCA) Chemical Substance Inventory'' and
identified by EPA ICR No. 1741.05 and OMB Control No. 2070-0145, is
scheduled to expire on February 29, 2008. Before submitting the ICR to
OMB for review and approval, EPA is soliciting comments on specific
aspects of the proposed information collection.

DATES:  Comments must be received on or before November 20, 2007.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2007-0272, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     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: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID number EPA-HQ-OPPT-2007-0272. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is<PHONE_NUMBER>. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2007-0272. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket

Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov web
site to view the docket index or access available documents. Although
listed in the index, some information is not publicly available, e.g.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, will be publicly
available only in hard copy. Publicly available docket materials are
available electronically at http://www.regulations.gov, or, if only

available in hard copy, at the OPPT Docket. The OPPT Docket is located
in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding Federal holidays. The telephone number of the EPA/DC Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPPT
Docket is<PHONE_NUMBER>. Docket visitors are required to show
photographic identification, pass through a metal detector, and sign
the EPA visitor log. All visitor bags are processed through an X-ray
machine and subject to search. Visitors will be provided an EPA/DC
badge that must be visible at all times in the building and returned
upon departure.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
    For technical information contact: Tracy Williamson, Economics,
Exposure, and Technology Division (7406M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-8569; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. What Information is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of PRA, EPA specifically solicits
comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What Should I Consider when I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the collection activity.

    7. Make sure to submit your comments by the deadline identified
under DATES.
    8. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

III. What Information Collection Activity or ICR Does this Action Apply
to?

    Affected entities: Entities potentially affected by this action are
manufacturers or importers of chemical substances, mixtures or
categories listed on the TSCA Inventory and regulated under TSCA
section 8, who had reported to the initial effort to establish the TSCA
Inventory in 1979, and who need to make a correction to that
submission.
    Title: Correction of Misreported Chemical Substances on the Toxic
Substances Control Act (TSCA) Chemical Substance Inventory.
    ICR numbers: EPA ICR No. 1741.05, OMB Control No. 2070-0145.
    ICR status: This ICR is currently scheduled to expire on February
29, 2008. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: Section 8(b) of TSCA requires EPA to compile and keep
current an Inventory of Chemical Substances in Commerce, which is a
listing of chemical substances manufactured, imported, and processed
for commercial purposes in the United States. The purpose of the
Inventory is to define, for the purpose of TSCA, what chemical
substances exist in U.S. Commerce. Since the Inventory thereby performs
a regulatory function by distinguishing between existing chemicals and
new chemicals, which TSCA regulates in different ways, it is imperative
that the Inventory be accurate.
    However, from time to time, EPA or respondents discover that
substances have been incorrectly described by reporting companies.
Reported substances have been unintentionally misidentified as a result
of simple typographical errors, the misidentification of substances, or
the lack of sufficient technical or analytical capabilities to
characterize fully the exact chemical substances. EPA has developed
guidelines (45 FR 50544, July 29, 1980) under which incorrectly
described substances listed in the Inventory can be corrected. The
correction mechanism ensures the accuracy of the Inventory without
imposing an unreasonable burden on the chemical industry. Without the
Inventory correction mechanism, a company that submitted incorrect
information would have to file a premanufacture notification (PMN)
under TSCA section 5 to place the correct chemical substance on the
Inventory whenever the previously reported substance is found to be
misidentified. This would impose a much greater burden on both EPA and
the submitter than the existing correction mechanism. This information
collection applies to reporting and recordkeeping activities associated
with the correction of misreported chemical substances found on the
TSCA Inventory.
    Responses to the collection of information are voluntary.
Respondents may claim all or part of a document confidential. EPA will
disclose information that is covered by a claim of confidentiality only
to the extent permitted by, and in accordance with, the procedures in
TSCA section 14 and 40 CFR part 2.
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to be 2.25 hours
per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal Agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of this estimate, which is
only briefly summarized here:
    Estimated total number of potential respondents: 9.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 20 hours.
    Estimated total annual costs: $1,061. This includes an estimated
burden cost of $1,061 and an estimated cost of $0 for capital
investment or maintenance and operational costs.

IV. Are There Changes in the Estimates from the Last Approval?

    There is no net change in the total estimated respondent burden
compared with that identified in the ICR currently approved by OMB.

V. What is the Next Step in the Process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce
the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the technical person listed under
FOR FURTHER INFORMATION CONTACT.

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: September 17, 2007.
James Jones,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.

[FR Doc. E7-18684 Filed 9-20-07; 8:45 am]

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