[Federal Register Volume 84, Number 69 (Wednesday, April 10, 2019)]
[Notices]
[Pages 14404-14412]
[FR Doc No: 2019-07039]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2013-0012]

Modification to the List of Appropriate NRTL Program Test
Standards and the Scopes of Recognition of Several NRTLs

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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SUMMARY: In this notice, OSHA announces its final decision to: (1) Add
a new test standard to the Nationally Recognized Testing Laboratories
(NRTL) Program's list of appropriate test standards; (2) delete or
replace several test standards from the NRTL Program's list of
appropriate test standards; and (3) update the scope of recognition of
several NRTLs.

DATES: The actions contained in this notice will become effective on
April 10, 2019.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications; telephone:<PHONE_NUMBER>; email:
[email protected].
    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration; telephone:<PHONE_NUMBER> or email:
[email protected]. OSHA's web page includes information about the
NRTL Program (see http://www.osha.gov/dts/otpca/nrtl/index.html).

SUPPLEMENTARY INFORMATION:

I. Background

    The NRTL Program recognizes organizations that provide product-
safety testing and certification services to manufacturers. These
organizations perform testing and certification for purposes of the
program, to U.S. consensus-based product-safety test standards. The
products covered by the NRTL Program consist of those items for which
OSHA safety standards require ``certification'' by a NRTL. The
requirements affect electrical products and 38 other types of products.
OSHA does not develop or issue these test standards, but generally
relies on standards development organizations (SDOs), which develop and
maintain the standards using a method that provides input and
consideration of views of industry groups, experts, users, consumers,
governmental authorities and others having broad experience in the
safety field involved.

Addition of New Test Standards to the NRTL List of Appropriate Test
Standards

    Periodically, OSHA will add new test standards to the NRTL list of
appropriate test standards following an evaluation of the test standard
document. To qualify as an appropriate test standard, the agency
evaluates the document to (1) verify it represents a product category
for which OSHA requires certification by a NRTL, (2) verify the
document represents an end product and not a component, and (3) verify
the document defines safety test specifications (not installation or
operational performance specifications). OSHA becomes aware of new test
standards through various avenues. For example, OSHA may become aware
of new test standards by: (1) Monitoring notifications issued by
certain SDOs; (2) reviewing applications by NRTLs or applicants seeking
recognition to include a new test standard in their scopes of
recognition; and (3) obtaining notification from manufacturers,
manufacturing organizations, government agencies, or other parties that
a new test standard may be appropriate to add to the list of
appropriate standards. OSHA may determine to include a new test
standard in the list, for example, if the test standard is for a
particular type of product that another test standard also covers,
addresses a type of product that no standard previously covered, or is
otherwise new to the NRTL Program.

SDO Deletion and Replacement of Test Standards

    The NRTL Program regulations require that appropriate test
standards be maintained and current (29 CFR 1910.7(c)). A test standard
withdrawn by a standards development organization is no longer
considered an appropriate test standard (Directive, App. C.XIV.B). It
is OSHA's policy to remove recognition of withdrawn test standards by
issuing a correction notice in the Federal Register for all NRTLs
recognized for the withdrawn test standards. However, SDOs frequently
will designate a replacement standard for withdrawn standards. OSHA
will recognize a NRTL for an appropriate replacement test standard if
the NRTL has the requisite testing and evaluation capability for the
replacement test standard.
    One method that NRTLs may use to show such capability involves an
analysis to determine whether any testing and evaluation requirements
of existing test standards in a NRTL's scope are comparable (i.e., are
completely or substantially identical) to the requirements in the
replacement test standard. If OSHA's analysis shows the replacement
test standard does not require additional or different technical
capability than an existing test standard(s), the replacement test
standard is comparable to the existing test standard(s), then OSHA can
add the replacement test standard to affected NRTLs' scopes of
recognition. If OSHA's analysis shows the replacement test standard
requires an additional or different technical capability, or the
replacement test standard is not comparable to any existing test
standards, each affected NRTL seeking to have OSHA add the replacement
test standard to the NRTL's scope of recognition must provide
information to OSHA that demonstrates technical capability.

Other Reasons for Removal of Test Standards From the NRTL List of
Appropriate Test Standards

    OSHA may choose to remove a test standard from the NRTL list of
appropriate test standards based on an internal review in which NRTL
Program staff review the NRTL list of appropriate test standards to
determine if the test standards conform to the definition of an
appropriate test standard defined in NRTL Program regulations and
policy. There are several reasons for removing a test standard based on
this review. First, a document that provides the methodology for a
single test is a test method rather than an appropriate test

standard (29 CFR 1910.7(c)). As stated above, a test standard must
specify the safety requirements for a specific type of product(s). A
test method, however, is a ``specified technical procedure for
performing a test'' (Directive, App. B). As such, a test method is not
an appropriate test standard. While a NRTL may use a test method to
determine if certain safety requirements are met, a test method is not
itself a safety requirement for a specific product category.
    Second, a document that focuses primarily on usage, installation,
or maintenance requirements would also not be considered an appropriate
test standard (Directive, App. D.IV.B). In some cases, however, a
document may also provide safety test specifications in addition to
usage, installation, and maintenance requirements. In such cases, the
document would be retained as an appropriate test standard based on the
safety test specifications.
    Finally, a document may not be considered an appropriate test
standard if the document covers products for which OSHA does not
require testing and certification (Directive, App. D.IV.A). Similarly,
a document that covers electrical product components would not be
considered an appropriate test standard. These documents apply to types
of components that have limitation(s) or condition(s) on their use,
which are not appropriate for use as end-use products. These documents
also specify that these types of components are for use only as part of
an end-use product. NRTLs, however, evaluate such components only in
the context of evaluating whether end-use products requiring NRTL
approval are safe for use in the workplace. Testing such components
alone would not indicate that the end-use products containing the
components are safe for use. Accordingly, as a matter of policy, OSHA
considers that documents covering such components are not appropriate
test standards under the NRTL Program. OSHA notes, however, that it is
not proposing to delete from NRTLs' scope of recognition any test
standards covering end-use products that contain such components.\1\
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    \1\ OSHA notes also that some types of devices covered by these
documents, such as capacitors and transformers, may be end-use
products themselves, and tested under other test standards
applicable to such products. For example, the following test
standard covers transformers that are end-use products: UL 1562
Standard for Transformers, Distribution, Dry-Type--Over 600 Volts.
OSHA is not proposing to delete such test standards from NRTLs'
scopes of recognition.
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    In addition, OSHA notes that, to conform to a test standard
covering an end-use product, a NRTL must still determine that the
components in the product comply with the components' specific test
standards. In making this determination, NRTLs may test the components
themselves, or accept the testing of a qualified testing organization
that a given component conforms to the particular test standard. OSHA
reviews each NRTL's procedures to determine which approach the NRTL
will use to address components, and reviews the end-use product testing
to verify the NRTL appropriately addresses that product's components.

Proposed Modification to the List of Appropriate NRTL Program Test
Standards and the Scope of Recognition of Several NRTLs

    In a November 6, 2014, Federal Register notice (79 FR 65991,
referred to in this notice as ``Proposed Modification,'' and available
at www.regulations.gov under Docket ID OSHA-2013-0012-0011), OSHA
proposed: adding several standards to the NRTL Program's List of
Appropriate Test Standards; deleting several withdrawn and deleted test
standards from the NRTL Program's list of appropriate test standards;
incorporating into the NRTL Program's list of appropriate test
standards replacement test standards for some of the withdrawn and
deleted test standards; and updating the scope of recognition of
several NRTLs. OSHA received two comments on proposed actions
(available at www.regulations.gov under Docket IDs OSHA-2013-0012-0013
and OSHA-2013-0012-0014). OSHA fully considered these comments, and in
this Notice, takes final action on the proposals.

II. Final Decision To Add a New Test Standard to the NRTL Program's
List of Appropriate Test Standards

    In this notice, OSHA announces the final decision to add one new
test standard, UL 60745-2-23, Hand-Held Motor-Operated Electric Tools--
Safety--Part 2-23: Particular Requirements for Die Grinders and Small
Rotary Tools, to the NRTL Program's list of appropriate test standards.
In the Proposed Modification, OSHA proposed adding sixteen test
standards to the NRTL Program's List of Appropriate Test Standards, as
described in Table 1:

 Table 1--Test Standards OSHA Proposed To Add to the NRTL Program's List
                      of Appropriate Test Standards
------------------------------------------------------------------------
          Test standard                     Test standard title
------------------------------------------------------------------------
AAMI HA60601-1-11................  Medical Electrical Equipment--Part 1-
                                    11: General requirements for basic
                                    safety and essential performance--
                                    Collateral Standard: Requirements
                                    for medical electrical equipment and
                                    medical electrical systems used in
                                    the home healthcare.
AAMI 60601-2-2...................  Medical Electrical Equipment--Part 2-
                                    2: Particular requirements for the
                                    basic safety and essential
                                    performance of high frequency
                                    surgery equipment and high frequency
                                    surgical accessories.
AAMI 60601-2-4...................  Medical Electrical Equipment--Part 2-
                                    4: Particular requirements for basic
                                    safety and essential performance of
                                    cardiac defibrillators.
AAMI 60601-2-16..................  Medical Electrical Equipment--Part 2-
                                    16: Particular requirements for
                                    basic safety and essential
                                    performance of hemodialysis,
                                    hemodiafiltration and hemofiltration
                                    equipment.
AAMI 60601-2-19..................  Medical Electrical Equipment--Part 2-
                                    19: Particular requirements for the
                                    basic safety and essential
                                    performance of infant incubators.
AAMI 60601-2-20..................  Medical Electrical Equipment--Part 2-
                                    20: Particular requirements for the
                                    basic safety and essential
                                    performance of infant transport
                                    incubators.
AAMI 60601-2-21..................  Medical Electrical Equipment--Part 2-
                                    21: Particular requirements for the
                                    basic safety and essential
                                    performance of infant radiant
                                    warmers.
AAMI 60601-2-25..................  Medical Electrical Equipment--Part 2-
                                    25: Particular requirements for the
                                    basic safety and essential
                                    performance of electrocardiographs.
AAMI 60601-2-27..................  Medical Electrical Equipment--Part 2-
                                    27: Particular requirements for the
                                    basic safety and essential
                                    performance of electrocardiographic
                                    monitoring equipment.

AAMI 60601-2-47..................  Medical Electrical Equipment--Part 2-
                                    47: Particular requirements for the
                                    basic safety and essential
                                    performance of ambulatory
                                    electrocardiographic systems.
AAMI 60601-2-50..................  Medical Electrical Equipment--Part 2-
                                    50: Particular requirements for the
                                    basic safety and essential
                                    performance of infant phototherapy
                                    equipment.
AAMI 80601-2-30..................  Medical Electrical Equipment--Part 2-
                                    30: Particular requirements for the
                                    basic safety and essential
                                    performance of automated non-
                                    invasive sphygmomanometers.
AAMI 80601-2-58..................  Medical Electrical Equipment--Part 2-
                                    58: Particular requirements for the
                                    basic safety and essential
                                    performance of lens removal devices
                                    and vitrectomy devices for
                                    ophthalmic surgery.
ISA 60079-25.....................  Explosive Atmospheres--Part 25:
                                    Intrinsically Safe Electrical
                                    Systems.
ISA 60079-27.....................  Explosive Atmospheres--Part 27:
                                    Fieldbus Intrinsically Safe Concept
                                    (FISCO) and Fieldbus Non-Incendive
                                    Concept (FNICO).
UL 60745-2-23....................  Hand-Held Motor-Operated Electric
                                    Tools--Safety--Part 2-23: Particular
                                    Requirements for Die Grinders and
                                    Small Rotary Tools.
------------------------------------------------------------------------

    One commenter, Curtis Strauss, LLC, a NRTL, asserted that OSHA
should not add 13 of these 16 test standards to the list of appropriate
test standards: AAMI HA60601-1-11; AAMI 60601-2-2; AAMI 60601-2-4; AAMI
60601-2-16; AAMI 60601-2-19; AAMI 60601-2-20; AAMI 60601-2-21; AAMI
60601-2-25; AAMI 60601-2-27; AAMI 60601-2-47; AAMI 60601-2-50; AAMI
80601-2-30; and AAMI 80601-2-58.
    In its final decision, OSHA decided not to adopt the 13 test
standards as they do not address worker safety. These collateral and
particular standards for AAMI ES 60601-1 do not fall under the scope
of, and are not appropriate test standards under, the NRTL Program
because they are primarily focused on essential performance of
equipment and patient safety, and not worker safety.
    In the final decision, OSHA also decided not to adopt the proposal
to add ISA 60079-25 to the List of Appropriate Test Standards because
doing so would lead to the placement of identical standards on the
list. This test standard has already been added to the List of
Appropriate Test Standards by a separate final action of the Agency
(see 81 FR 91204 (Dec. 16, 2016), available on www.regulations.gov
under Docket ID OSHA-2007-0039-0024).
    Finally, in the final decision, OSHA decided not to adopt the
proposal to add ISA 60079-27 to the List of Appropriate Test Standards.
This standard is in the process of being withdrawn by ISA, as the
substance of the standard has been added to other test standards (UL
60079-11 and UL 60079-25), which are already in the NRTL Program's List
of Appropriate Test.
    Table 2 and 3, summarize OSHA's final decisions on adding the
subject test standards to its List of Appropriate Test Standards.

  Table 2--Test Standards OSHA Decided Not To Add to the NRTL Program's
  List of Appropriate Test Standards and Rationales for Final Decisions
------------------------------------------------------------------------
         Test standard          Test standard title    Agency decision
------------------------------------------------------------------------
AAMI HA60601-1-11.............  Medical Electrical   This standard does
                                 Equipment--Part 1-   not fall under the
                                 11: General          scope of the NRTL
                                 requirements for     Program.
                                 basic safety and
                                 essential
                                 performance--Colla
                                 teral Standard:
                                 Requirements for
                                 Medical Electrical
                                 Equipment and
                                 medical electrical
                                 systems used in
                                 the home
                                 healthcare.
AAMI 60601-2-2................  Medical Electrical   This standard does
                                 Equipment--Part 2-   not fall under the
                                 2: Particular        scope of the NRTL
                                 requirements for     Program.
                                 the basic safety
                                 and essential
                                 performance of
                                 high frequency
                                 surgery equipment
                                 and high frequency
                                 surgical
                                 accessories.
AAMI 60601-2-4................  Medical Electrical   This standard does
                                 Equipment--Part 2-   not fall under the
                                 4: Particular        scope of the NRTL
                                 requirements for     Program.
                                 basic safety and
                                 essential
                                 performance of
                                 cardiac
                                 defibrillators.
AAMI 60601-2-16...............  Medical Electrical   This standard does
                                 Equipment--Part 2-   not fall under the
                                 16: Particular       scope of the NRTL
                                 requirements for     Program.
                                 basic safety and
                                 essential
                                 performance of
                                 hemodialysis,
                                 hemodiafiltration
                                 and hemofiltration
                                 equipment.
AAMI 60601-2-19...............  Medical Electrical   This standard does
                                 Equipment--Part 2-   not fall under the
                                 19: Particular       scope of the NRTL
                                 requirements for     Program.
                                 the basic safety
                                 and essential
                                 performance of
                                 infant incubators.
AAMI 60601-2-20...............  Medical Electrical   This standard does
                                 Equipment--Part 2-   not fall under the
                                 20: Particular       scope of the NRTL
                                 requirements for     Program.
                                 the basic safety
                                 and essential
                                 performance of
                                 infant transport
                                 incubators.
AAMI 60601-2-21...............  Medical Electrical   This standard does
                                 Equipment--Part 2-   not fall under the
                                 21: Particular       scope of the NRTL
                                 requirements for     Program.
                                 the basic safety
                                 and essential
                                 performance of
                                 infant radiant
                                 warmers.
AAMI 60601-2-25...............  Medical Electrical   This standard does
                                 Equipment--Part 2-   not fall under the
                                 25: Particular       scope of the NRTL
                                 requirements for     Program.
                                 the basic safety
                                 and essential
                                 performance of
                                 electrocardiograph
                                 s.
AAMI 60601-2-27...............  Medical Electrical   This standard does
                                 Equipment--Part 2-   not fall under the
                                 27: Particular       scope of the NRTL
                                 requirements for     Program.
                                 the basic safety
                                 and essential
                                 performance of
                                 electrocardiograph
                                 ic monitoring
                                 equipment.
AAMI 60601-2-47...............  Medical Electrical   This standard does
                                 Equipment--Part 2-   not fall under the
                                 47: Particular       scope of the NRTL
                                 requirements for     Program.
                                 the basic safety
                                 and essential
                                 performance of
                                 ambulatory
                                 electrocardiograph
                                 ic systems.

AAMI 60601-2-50...............  Medical Electrical   This standard does
                                 Equipment--Part 2-   not fall under the
                                 50: Particular       scope of the NRTL
                                 requirements for     Program.
                                 the basic safety
                                 and essential
                                 performance of
                                 infant
                                 phototherapy
                                 equipment.
AAMI 80601-2-30...............  Medical Electrical   This standard does
                                 Equipment--Part 2-   not fall under the
                                 30: Particular       scope of the NRTL
                                 requirements for     Program.
                                 the basic safety
                                 and essential
                                 performance of
                                 automated non-
                                 invasive
                                 sphygmomanometers.
AAMI 80601-2-58...............  Medical Electrical   This standard does
                                 Equipment--Part 2-   not fall under the
                                 58: Particular       scope of the NRTL
                                 requirements for     Program.
                                 the basic safety
                                 and essential
                                 performance of
                                 lens removal
                                 devices and
                                 vitrectomy devices
                                 for ophthalmic
                                 surgery.
ISA 60079-25..................  Explosive            This standard was
                                 Atmospheres--Part    added as an
                                 25: Intrinsically    appropriate test
                                 Safe Electrical      standard in a
                                 Systems.             separate final
                                                      action of the
                                                      Agency.
ISA 60079-27..................  Explosive            This standard is
                                 Atmospheres--Part    currently being
                                 27: Fieldbus         withdrawn by ISA.
                                 Intrinsically Safe
                                 Concept (FISCO)
                                 and Fieldbus Non-
                                 Incendive Concept
                                 (FNICO).
------------------------------------------------------------------------

Table 3--Test Standard OSHA Decided To Add to the NRTL Program's List of
                       Appropriate Test Standards
------------------------------------------------------------------------
          Test standard                     Test standard title
------------------------------------------------------------------------
UL 60745-2-23....................  Hand-Held Motor-Operated Electric
                                    Tools--Safety--Part 2-23: Particular
                                    Requirements for Die Grinders and
                                    Small Rotary Tools
------------------------------------------------------------------------

III. Final Decision To Delete or Replace Several Test Standards From
the NRTL Program's List of Appropriate Test Standards

    In this notice, OSHA announces the final decision to delete seven
withdrawn and deleted test standards from the NRTL Program's List of
Appropriate Test Standards. OSHA also incorporates into the NRTL
Program's List of Appropriate Test Standards replacement test standards
for some of the withdrawn and deleted test standards. (See Table 4).
    In the proposed modification, OSHA proposed deleting eight
standards from the NRTL Program's List of Appropriate Test Standards,
the seven standards listed in Table 4, and one additional standard, FM
3620--Purged and Pressurized Electrical Equipment for Hazardous
Locations. OSHA proposed deleting FM 3620 because the references are
out-of date standards, and proposed replacing FM 3620 with NFPA 496--
Purged and Pressurized Enclosures for Electrical Equipment. Given this
proposal, OSHA also proposed deleting FM 3620 from the scopes of
recognition of NRTLs FM Approvals, LLC and Canadian Standards
Association, and replacing that standard in those NRTLs' scope of
recognition with NFPA 496.
    In a comment to the Proposed Modification (available on
www.regulations.gov under Docket ID OSHA-2013-0012-0014), FM Approvals
asked that OSHA not change its existing scope of recognition, as
proposed, because FM Approvals updated FM 3620 in December 2014 (after
OSHA issued the proposed modification), so that the test standard no
longer contains references to out-of-date standards. FM Approvals
included the updated test standard as part of the comment in attachment
to its comment.
    OSHA has fully reviewed the test standard submitted by FM Approvals
and confirmed FM Approvals' assertions. Therefore, in this final
decision, OSHA will not delete FM 3620 from the List of Appropriate
Test Standards, or delete FM 3620 from the scope of recognition of FM
Approvals, LLC or Canadian Standards Association, or replace that
standard in those NRTLs' scopes of recognition with NFPA 496.
    Table 4 lists the seven test standards OSHA will delete from the
NRTL Program's list of appropriate test standards, as well as
abbreviated rationales for OSHA's final action. For a full discussion
of the rationales, see Section I of this notice. Table 4 also lists
corresponding replacement test standards that OSHA will incorporate
into the NRTL Program's list of appropriate test standards (when
applicable).
    OSHA notes also that Table 4 lists the subject test standards and
corresponding actions taken with regard to each of these test standards
without indicating how the actions will affect individual NRTLs.
Section IV of this notice discusses how these actions will affect
individual NRTLs.

 Table 4--List of Test Standards OSHA Is Deleting From or Incorporating
                    Into NRTLs Scopes of Recognition
------------------------------------------------------------------------
                                                      Replacement test
    Deleted test standard      Reason for deletion     standard(s) (if
                                                         applicable)
------------------------------------------------------------------------
UL 60950--Information         Standard has been     UL 60950-1--
 Technology Equipment.         withdrawn and         Information
                               directly replaced     Technology
                               by a new standard.    Equipment--Safety--
                                                     Part 1: General
                                                     Requirements is
                                                     currently listed as
                                                     an appropriate NRTL
                                                     standard.
UL 61010A-1--Electrical       These three           UL 61010-1--
 Equipment for Laboratory      standards have been   Electrical
 Use; Part 1: General          withdrawn and         Equipment for
 Requirements.                 consolidated into a   Measurement,
                               single standard.      Control, and
                                                     Laboratory Use;
                                                     Part 1: General
                                                     Requirements is
                                                     currently listed as
                                                     an appropriate NRTL
                                                     standard.

UL 61010B-1--Electrical
 Measuring and Test
 Equipment; Part 1: General
 Requirements.
UL 61010C-1--Process Control
 Equipment.
UL 1004--Electrical Motors    Standard has been     UL 1004-1--Rotating
 (This standard has already    withdrawn.            Electrical
 been removed).                                      machines--General
                                                     Requirements is
                                                     currently listed as
                                                     an appropriate NRTL
                                                     standard.
UL 681- Installation and      Standard is an        None.
 Classification of Burglar     installation
 and Holdup Alarm System.      standard and not an
                               end-product
                               standard. It does
                               not meet the
                               requirements of the
                               NRTL Program.
UL 827--Central-Station       Standard is an        None.
 Alarm Services.               installation
                               standard and not an
                               end-product
                               standard. It does
                               not meet the
                               requirements of the
                               NRTL Program.
------------------------------------------------------------------------

IV. Final Decision To Modify Affected NRTLs' Scope of Recognition

    In this notice, OSHA announces the final decision to update the
scope of recognition of several NRTLs. The tables in this section
(Table 5 thru Table 18) list, for each affected NRTL, the test
standard(s) that OSHA will delete from the scope of recognition and,
when applicable, the test standard(s) that OSHA will incorporate into
the scope of recognition to replace withdrawn (and deleted) test
standards.
    In this final decision, OSHA adopts the proposed modifications to
affected NRTLs' Scope of Recognition, and Table 5 thru Table 18 are
identical to Table 3 thru Table 16 of the Proposed Modification, with
certain exceptions:
     OSHA proposed deleting FM 3620 from the scopes of
recognition of NRTLs FM Approvals, LLC, and Canadian Standards
Association, and replacing that standard in those NRTLs' scopes of
recognition with NFPA 496. As explained in Section III of this notice,
in this final decision, OSHA will not delete FM 3620 from the List of
Appropriate Test Standards, or delete FM 3620 from the scopes of
recognition of FM Approvals, LLC or Canadian Standards Association, or
replace that standard in those NRTLs' scopes of recognition with NFPA
496. Thus, Table 5 thru Table 18 do not include entries discussing FM
3620 or NFPA 496.
     OSHA proposed deleting UL 1004--Electrical Motors from the
scopes of recognition of six NRTLs (Canadian Standards Association;
Intertek Testing Services NA, Inc.; TUV Rhineland of North America,
Inc.; TUV SUD America, Inc.; TUV SUD Product Services; Underwriters
Laboratories, Inc.). OSHA also proposed UL 1004-1--Rotating Electrical
Machines as a replacement test standard for UL 1004, but noted that
``NRTLs wishing to add UL 1004-1 must submit an application to OSHA.''
Table 5 thru Table 18 reflect whether the subject NRTLs have received
recognition for UL 1004-1.

  Table 5--Test Standards OSHA Will Delete From or Incorporate Into the
      Scope of Recognition of Canadian Standards Association (CSA)
------------------------------------------------------------------------
                                                      Replacement test
    Deleted test standard      Reason for deletion     standard(s) (if
                                                         applicable)
------------------------------------------------------------------------
UL 1004--Electrical Motors..  Standard has been     UL 1004-1--Rotating
                               withdrawn.            Electrical
                                                     Machines, see 80 FR
                                                     76044, Dec. 7,
                                                     2015.
UL 60950--Information         Standard has been     UL 60950-1--
 Technology Equipment.         withdrawn and         Information
                               directly replaced     Technology
                               by a new standard.    Equipment--Safety--
                                                     Part 1: General
                                                     Requirements.
UL 61010A-1--Electrical       These standards have  UL 61010-1--
 Equipment for Laboratory      been withdrawn and    Electrical
 Use; Part 1: General          consolidated into a   Equipment for
 Requirements.                 single standard.      Measurement,
                                                     Control, and
                                                     Laboratory Use;
                                                     Part 1: General
                                                     Requirements.
UL 61010B-1--Electrical
 Measuring and Test
 Equipment; Part 1: General
 Requirements.
UL 61010C-1--Process Control
 Equipment.
UL 681--Installation and      Standard is an        None.
 Classification of Burglar     installation
 and Holdup Alarm System.      standard and not an
                               end-product
                               standard. It does
                               not meet the
                               requirements of the
                               NRTL Program.
UL 827--Central-Station       Standard is an        None.
 Alarm Services.               installation
                               standard and not an
                               end-product
                               standard. It does
                               not meet the
                               requirements of the
                               NRTL Program.
------------------------------------------------------------------------

  Table 6--Test Standards OSHA Will Delete From or Incorporate Into the
             Scope of Recognition of Curtis-Straus LLC (CSL)
------------------------------------------------------------------------
                                                      Replacement test
    Deleted test standard      Reason for deletion     standard(s) (if
                                                         applicable)
------------------------------------------------------------------------
UL 60950--Information         Standard has been     UL 60950-1--
 Technology Equipment.         withdrawn and         Information
                               directly replaced     Technology
                               by a new standard.    Equipment--Safety--
                                                     Part 1: General
                                                     Requirements.
UL 61010A-1--Electrical       These standards have  UL 61010-1--
 Equipment for Laboratory      been withdrawn and    Electrical
 Use; Part 1: General          consolidated into a   Equipment for
 Requirements.                 single standard.      Measurement,
                                                     Control, and
                                                     Laboratory Use;
                                                     Part 1: General
                                                     Requirements.
UL 61010B-1--Electrical
 Measuring and Test
 Equipment; Part 1: General
 Requirements.
------------------------------------------------------------------------

Table 7--Test Standards OSHA Proposes To Delete From or Incorporate Into
             the Scope of Recognition FM Approvals LLC (FM)
------------------------------------------------------------------------
                                                      Replacement test
    Deleted test standard      Reason for deletion     standard(s) (if
                                                         applicable)
------------------------------------------------------------------------
UL 60950--Information         Standard has been     UL 60950-1--
 Technology Equipment.         withdrawn and         Information
                               directly replaced     Technology
                               by a new standard.    Equipment--Safety--
                                                     Part 1: General
                                                     Requirements.
UL 61010A-1--Electrical       These standards have  UL 61010-1--
 Equipment for Laboratory      been withdrawn and    Electrical
 Use; Part 1: General          consolidated into a   Equipment for
 Requirements.                 single standard.      Measurement,
                                                     Control, and
                                                     Laboratory Use;
                                                     Part 1: General
                                                     Requirements.
UL 61010B-1--Electrical
 Measuring and Test
 Equipment; Part 1: General
 Requirements.
UL 827--Central-Station       Standard is an        None.
 Alarm Services.               installation
                               standard and not an
                               end-product
                               standard. It does
                               not meet the
                               requirements of the
                               NRTL Program.
------------------------------------------------------------------------

  Table 8--Test Standards OSHA Will Delete From or Incorporate Into the
   Scope of Recognition of Intertek Testing Services NA, Inc. (ITSNA)
------------------------------------------------------------------------
                                                      Replacement test
    Deleted test standard      Reason for deletion     standard(s) (if
                                                         applicable)
------------------------------------------------------------------------
UL 1004--Electrical Motors..  Standard has been     UL 1004-1--Rotating
                               withdrawn.            Electrical
                                                     Machines, see 79 FR
                                                     62676, Oct. 20,
                                                     2014.
UL 60950--Information         Standard has been     UL 60950-1--
 Technology Equipment.         withdrawn and         Information
                               directly replaced     Technology
                               by a new standard.    Equipment--Safety--
                                                     Part 1: General
                                                     Requirements.
UL 61010A-1--Electrical       These standards have  UL 61010-1--
 Equipment for Laboratory      been withdrawn and    Electrical
 Use; Part 1: General          consolidated into a   Equipment for
 Requirements.                 single standard.      Measurement,
                                                     Control, and
                                                     Laboratory Use;
                                                     Part 1: General
                                                     Requirements.
UL 61010B-1--Electrical
 Measuring and Test
 Equipment; Part 1: General
 Requirements.
UL 61010C-1--Process Control
 Equipment.
UL 681- Installation and      Standard is an        None.
 Classification of Burglar     installation
 and Holdup Alarm System.      standard and not an
                               end-product
                               standard. It does
                               not meet the
                               requirements of the
                               NRTL Program.
UL 827--Central-Station       Standard is an        None.
 Alarm Services.               installation
                               standard and not an
                               end-product
                               standard. It does
                               not meet the
                               requirements of the
                               NRTL Program.
------------------------------------------------------------------------

  Table 9--Test Standards OSHA Will Delete From or Incorporate Into the
          Scope of Recognition of MET Laboratories, Inc. (MET)
------------------------------------------------------------------------
                                                      Replacement test
    Deleted test standard      Reason for deletion     standard(s) (if
                                                         applicable)
------------------------------------------------------------------------
UL 60950--Information         Standard has been     UL 60950-1--
 Technology Equipment.         withdrawn and         Information
                               directly replaced     Technology
                               by a new standard.    Equipment--Safety--
                                                     Part 1: General
                                                     Requirements.
UL 61010A-1--Electrical       These standards have  UL 61010-1--
 Equipment for Laboratory      been withdrawn and    Electrical
 Use; Part 1: General          consolidated into a   Equipment for
 Requirements.                 single standard.      Measurement,
                                                     Control, and
                                                     Laboratory Use;
                                                     Part 1: General
                                                     Requirements.
UL 61010B-1--Electrical
 Measuring and Test
 Equipment; Part 1: General
 Requirements.
UL 61010C-1--Process Control
 Equipment.
------------------------------------------------------------------------

 Table 10--Test Standards OSHA Will Delete From or Incorporate Into the
         Scope of Recognition of Nemko North America, Inc. (NNA)
------------------------------------------------------------------------
                                                      Replacement test
    Deleted test standard      Reason for deletion     standard(s) (if
                                                         applicable)
------------------------------------------------------------------------
UL 60950--Information         Standard has been     UL 60950-1--
 Technology Equipment.         withdrawn and         Information
                               directly replaced     Technology
                               by a new standard.    Equipment--Safety--
                                                     Part 1: General
                                                     Requirements.
UL 61010A-1--Electrical       Standard has been     UL 61010-1--
 Equipment for Laboratory      withdrawn and         Electrical
 Use; Part 1: General          consolidated with     Equipment for
 Requirements.                 others into a         Measurement,
                               single standard.      Control, and
                                                     Laboratory Use;
                                                     Part 1: General
                                                     Requirements.
------------------------------------------------------------------------

  Table 11--Test Standard OSHA Will Delete From or Incorporate Into the
             Scope of Recognition of NSF International (NSF)
------------------------------------------------------------------------
                                                      Replacement test
    Deleted test standard      Reason for deletion     standard(s) (if
                                                         applicable)
------------------------------------------------------------------------
UL 61010A-1--Electrical       Standard has been     UL 61010-1--
 Equipment for Laboratory      withdrawn and         Electrical
 Use; Part 1: General          consolidated with     Equipment for
 Requirements.                 others into a         Measurement,
                               single standard.      Control, and
                                                     Laboratory Use;
                                                     Part 1: General
                                                     Requirements.
------------------------------------------------------------------------

  Table 12--Test Standard OSHA Will Delete From or Incorporate Into the
          Scope of Recognition of QPS Evaluation Services (QPS)
------------------------------------------------------------------------
                                                      Replacement test
    Deleted test standard      Reason for deletion     standard(s) (if
                                                         applicable)
------------------------------------------------------------------------
UL 60950--Information         Standard has been     UL 60950-1--
 Technology Equipment.         withdrawn and         Information
                               directly replaced     Technology
                               by a new standard.    Equipment--Safety--
                                                     Part 1: General
                                                     Requirements.
------------------------------------------------------------------------

 Table 13--Test Standards OSHA Will Delete From or Incorporate Into the
           Scope of Recognition SGS North America, Inc. (SGS)
------------------------------------------------------------------------
                                                      Replacement test
    Deleted test standard      Reason for deletion     standard(s) (if
                                                         applicable)
------------------------------------------------------------------------
UL 60950--Information         Standard has been     UL 60950-1--
 Technology Equipment.         withdrawn and         Information
                               directly replaced     Technology
                               by a new standard.    Equipment--Safety--
                                                     Part 1: General
                                                     Requirements.
UL 61010A-1--Electrical       These standards have  UL 61010-1--
 Equipment for Laboratory      been withdrawn and    Electrical
 Use; Part 1: General          consolidated into a   Equipment for
 Requirements.                 single standard.      Measurement,
                                                     Control, and
                                                     Laboratory Use;
                                                     Part 1: General
                                                     Requirements.
UL 61010B-1--Electrical
 Measuring and Test
 Equipment; Part 1: General
 Requirements.
------------------------------------------------------------------------

  Table 14--Test Standard OSHA Will Delete From or Incorporate Into the
       Scope of Recognition of Southwest Research Institute (SWRI)
------------------------------------------------------------------------
                                                      Replacement test
    Deleted test standard      Reason for deletion     standard(s) (if
                                                         applicable)
------------------------------------------------------------------------
UL 60950--Information         Standard has been     UL 60950-1--
 Technology Equipment.         withdrawn and         Information
                               directly replaced     Technology
                               by a new standard.    Equipment--Safety--
                                                     Part 1: General
                                                     Requirements.
------------------------------------------------------------------------

 Table 15--Test Standards OSHA Will Delete From or Incorporate Into the
   Scope of Recognition of TUV Rhineland of North America, Inc. (TUV)
------------------------------------------------------------------------
                                                      Replacement test
    Deleted test standard      Reason for deletion     standard(s) (if
                                                         applicable)
------------------------------------------------------------------------
UL 1004--Electrical Motors..  Standard has been     UL 1004-1--Rotating
                               withdrawn.            Electrical
                                                     Machines, see 82 FR
                                                     7866, Jan. 20,
                                                     2017.
UL 60950--Information         Standard has been     UL 60950-1--
 Technology Equipment.         withdrawn and         Information
                               directly replaced     Technology
                               by a new standard.    Equipment--Safety--
                                                     Part 1: General
                                                     Requirements.

UL 61010A-1--Electrical       These standards have  UL 61010-1--
 Equipment for Laboratory      been withdrawn and    Electrical
 Use; Part 1: General          consolidated into a   Equipment for
 Requirements.                 single standard.      Measurement,
                                                     Control, and
                                                     Laboratory Use;
                                                     Part 1: General
                                                     Requirements.
UL 61010B-1--Electrical
 Measuring and Test
 Equipment; Part 1: General
 Requirements.
UL 61010C-1--Process Control
 Equipment.
UL 681- Installation and      Standard is an        None.
 Classification of Burglar     installation
 and Holdup Alarm System.      standard and not an
                               end-product
                               standard. It does
                               not meet the
                               requirements of the
                               NRTL Program.
UL 827--Central-Station       Standard is an        None.
 Alarm Services.               installation
                               standard and not an
                               end-product
                               standard. It does
                               not meet the
                               requirements of the
                               NRTL Program.
------------------------------------------------------------------------

 Table 16--Test Standards OSHA Will Delete From or Incorporate Into the
          Scope of Recognition of TUV SUD America, Inc. (TUVAM)
------------------------------------------------------------------------
                                                      Replacement test
    Deleted test standard      Reason for deletion     standard(s) (if
                                                         applicable)
------------------------------------------------------------------------
UL 1004--Electrical Motors..  Standard has been     Application pending
                               withdrawn.            to add UL 1004-1--
                                                     Rotating Electrical
                                                     Machines to TUVAM's
                                                     scope of
                                                     recognition.
UL 60950--Information         Standard has been     UL 60950-1--
 Technology Equipment.         withdrawn and         Information
                               directly replaced     Technology
                               by a new standard.    Equipment--Safety--
                                                     Part 1: General
                                                     Requirements.
UL 61010A-1--Electrical       These standards have  UL 61010-1--
 Equipment for Laboratory      been withdrawn and    Electrical
 Use; Part 1: General          consolidated into a   Equipment for
 Requirements.                 single standard.      Measurement,
                                                     Control, and
                                                     Laboratory Use;
                                                     Part 1: General
                                                     Requirements.
UL 61010B-1--Electrical
 Measuring and Test
 Equipment; Part 1: General
 Requirements.
------------------------------------------------------------------------

 Table 17--Test Standards OSHA Will Delete From or Incorporate Into the
        Scope of Recognition of TUV SUD Product Services (TUVPSG)
------------------------------------------------------------------------
                                                      Replacement test
    Deleted test standard      Reason for deletion     standard(s) (if
                                                         applicable)
------------------------------------------------------------------------
UL 1004--Electrical Motors..  Standard has been     Application pending
                               withdrawn.            to add UL 1004-1--
                                                     Rotating Electrical
                                                     Machines to
                                                     TUVPSG's scope of
                                                     recognition.
UL 60950--Information         Standard has been     UL 60950-1--
 Technology Equipment.         withdrawn and         Information
                               directly replaced     Technology
                               by a new standard.    Equipment--Safety--
                                                     Part 1: General
                                                     Requirements.
UL 61010A-1--Electrical       These standards have  UL 61010-1--
 Equipment for Laboratory      been withdrawn and    Electrical
 Use; Part 1: General          consolidated into a   Equipment for
 Requirements.                 single standard.      Measurement,
                                                     Control, and
                                                     Laboratory Use;
                                                     Part 1: General
                                                     Requirements.
UL 61010B-1--Electrical
 Measuring and Test
 Equipment; Part 1: General
 Requirements.
------------------------------------------------------------------------

 Table 18--Test Standards OSHA Will Delete From or Incorporate Into the
       Scope of Recognition of Underwriters Laboratories Inc. (UL)
------------------------------------------------------------------------
                                                      Replacement test
    Deleted test standard      Reason for deletion     standard(s) (if
                                                         applicable)
------------------------------------------------------------------------
UL 1004--Electrical Motors..  Standard has been     UL 1004-1--Rotating
                               withdrawn.            Electrical
                                                     Machines, see 79 FR
                                                     63949, Oct. 27,
                                                     2014.
UL 60950--Information         Standard has been     UL 60950-1--
 Technology Equipment.         withdrawn and         Information
                               directly replaced     Technology
                               by a new standard.    Equipment--Safety--
                                                     Part 1: General
                                                     Requirements.
UL 61010A-1--Electrical       These standards have  UL 61010-1--
 Equipment for Laboratory      been withdrawn and    Electrical
 Use; Part 1: General          consolidated into a   Equipment for
 Requirements.                 single standard.      Measurement,
                                                     Control, and
                                                     Laboratory Use;
                                                     Part 1: General
                                                     Requirements.
UL 61010B-1--Electrical
 Measuring and Test
 Equipment; Part 1: General
 Requirements.

UL 681- Installation and      Standard is an        None.
 Classification of Burglar     installation
 and Holdup Alarm System.      standard and not an
                               end-product
                               standard. It does
                               not meet the
                               requirements of the
                               NRTL Program.
UL 827--Central-Station       Standard is an        None.
 Alarm Services.               installation
                               standard and not an
                               end-product
                               standard. It does
                               not meet the
                               requirements of the
                               NRTL Program.
------------------------------------------------------------------------

    OSHA will place any modifications on informational web pages to
each NRTL's scope of recognition. These web pages detail the scope of
recognition for each NRTL, including the test standards the NRTL may
use to test and certify products under OSHA's NRTL Program. OSHA also
will add to the ``Current List of Appropriate Test Standards under the
NRTL Program'' web page, those test standards added to the NRTL list of
appropriate test standards. The agency will add, to the ``Current List
of Removed Test Standards'' web page those test standards that OSHA no
longer recognizes or permits under the NRTL Program. Access to these
web pages is available at http://www.osha.gov/dts/otpca/nrtl/index.html.

V. Authority and Signature

    Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational
Safety and Health, authorized the preparation of this notice.
Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C.
657(g)(2)), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25,
2012), and 29 CFR 1910.7.

    Signed at Washington, DC, on April 3, 2019.
Loren Sweatt,
Acting Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2019-07039 Filed 4-9-19; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Notices]
[Pages 13552-13553]
[FR Doc No: 2018-06296]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82936; File No. SR-CBOE-2018-008]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change Relating to Flexibly Structured Options

March 23, 2018.
    On January 19, 2018, Cboe Exchange, Inc. (``Exchange'') filed with
the Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to amend the
Exchange's rules relating to the fungibility of Flexible Exchange
Options (``FLEX Options'') with Non-FLEX Options that have identical
terms to, among other things, include FLEX Options on quarterly
expirations, short term expirations, weekly expirations and end-of-
month expirations. The proposed rule change was published for comment
in the Federal Register on February 8, 2018.\3\ The Commission has
received no comments on the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 82622 (Feb. 2,
2018), 83 FR 5668 (Feb. 8, 2018) (``Notice'').
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up

to 90 days as the Commission may designate if it finds such longer
period to be appropriate and publishes its reasons for so finding or as
to which the self-regulatory organization consents, the Commission
shall approve the proposed rule change, disapprove the proposed rule
change, or institute proceedings to determine whether the proposed rule
change should be approved or disapproved. The 45th day after
publication of the notice for this proposed rule change is March 25,
2018. The Commission is extending this 45-day time period.
---------------------------------------------------------------------------

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

    The Commission finds that it is appropriate to designate a longer
period within which to take action on the proposed rule change so that
the Commission has sufficient time to consider the proposed rule
change. Accordingly, the Commission, pursuant to Section 19(b)(2) of
the Act,\5\ designates May 9, 2018, as the date by which the Commission
should approve or disapprove or institute proceedings to determine
whether to disapprove the proposed rule change (File Number SR-CBOE-
2018-008).
---------------------------------------------------------------------------

    \5\ Id.
    \6\ 17 CFR 200.30-3(a)(31).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
Brent J. Fields,
Secretary.
[FR Doc. 2018-06296 Filed 3-28-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 152 (Wednesday, August 7, 2019)]
[Notices]
[Pages 38633-38634]
[FR Doc No: 2019-16889]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2018-N-4131, FDA-2018-N-0821, FDA-2013-N-0032, FDA-
2014-N-0801, FDA-2007-D-0429, FDA-2013-N-0013, and FDA-2008-D-0530]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at http://www.reginfo.gov/public/do/PRAMain. 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.

        Table 1--List of Information Collections Approved By OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                number          expires
------------------------------------------------------------------------
FDA Adverse Event and Products                 0910-0645       6/30/2022
 Experience Reports; Electronic
 Submissions............................
Investigation of Consumer Perceptions of       0910-0873       6/30/2022
 Expressed Modified Risk Claims.........
Food Labeling: Notification Procedures         0910-0331       7/31/2022
 for Statements on Dietary Supplements..
Export Notification and Recordkeeping          0910-0482       7/31/2022
 Requirements...........................
Labeling of Nonprescription Human Drug         0910-0641       7/31/2022
 Products Marketed Without an Approved
 Application as Required by the Dietary
 Supplement and Nonprescription Drug
 Consumer Protection Act................
Sanitary Transportation of Human and           0910-0773       7/31/2022
 Animal Food............................
Guidance for Industry on Tropical              0910-0822       7/31/2022
 Disease Priority Review Vouchers.......
------------------------------------------------------------------------

    Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16889 Filed 8-6-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: September 1, 2006 (Volume 71, Number 170)]
[Notices]
[Page 52198-52199]
[DOCID:fr01se06-95]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54367; File No. SR-DTC-2006-09]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Filing and Immediate Effectiveness of Proposed Rule To Revise
the DTC Custody Service Guide To Incorporate the Terms of Certain
Participant Agreements

 August 25, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on May 19, 2006, The
Depository Trust Company (``DTC'') filed with the Securities and
Exchange Commission (``Commission'') a proposed rule change and on June
23, 2006, amended the proposed rule change described in Items I, II,
and III below, which items have been prepared primarily by DTC. DTC
filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of
the Act \2\ and Rule 19b-4(f)(4) thereunder \3\ so that the proposal
was effective upon filing with the Commission. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested parties.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \3\ 17 CFR 240.19b-4(f)(4).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The proposed rule change would incorporate the terms and conditions
of certain participant agreements related to DTC's custody service into
the DTC Custody Service Guide.

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

    In its filing with the Commission, DTC 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. DTC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.\4\
---------------------------------------------------------------------------

    \4\ The Commission has modified the text of the summaries
prepared by DTC.
---------------------------------------------------------------------------

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

    DTC is filing the proposed rule change to incorporate the terms and
conditions of various participant agreements relating to DTC's custody
service into the DTC Custody Service Guide (``Guide'').\5\
Specifically, DTC is incorporating the terms of three custody service
participant agreements into the Guide: (i) The High Value Letter,\6\
(ii) New York Window Service Agreement,\7\ and (iii) Medallion
Signature Guarantee/Stamp Letter.\8\ The terms proposed to be

incorporated by this filing into the Guide match those currently
included in the agreements thereby affording both DTC and its
participants the same rights and responsibilities as those afforded by
the agreements.
---------------------------------------------------------------------------

    \5\ For background information on the Custody Service Guide,
which replaced applicable participant operating procedures relating
to the custody service, see Securities Exchange Act Release No. 34-
44719 (August 17, 2001), 66 FR 44656 (August 24, 2001) [File No. SR-
DTC-2001-01].
    \6\ The High Value Letter defines the extent of loss that DTC
would incur in connection with the processing of certain ``high
value'' certificates as being limited by the extent of the DTC
insurance coverage at the time of an incident of loss.
    \7\ The New York Window Service Agreement sets forth the terms
and conditions for a participant's use of the New York Window
Service, a service offered under the umbrella of DTC's custody
service.
    \8\ The Medallion Signature Guarantee/Stamp Letter sets forth
the terms and conditions for DTC's use of certain participant stamps
and medallions in connection with the New York Window Service.
---------------------------------------------------------------------------

    DTC believes that the proposed rule change is consistent with the
requirements of the Act, as amended, and the rules and regulations
thereunder because it incorporates existing terms of DTC participant
agreements into DTC's Guide and thus facilitates the safeguarding of
securities in DTC's custody or control.

(B) Self-Regulatory Organization's Statement on Burden on Competition

    DTC does not believe that the proposed rule change will have any
impact or impose any burden on competition.

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

    Written comments relating to the proposed rule change have not yet
been solicited or received. DTC will notify the Commission of any
written comments received by DTC.

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

    The foregoing rule change has become effective upon filing pursuant
to Section 19(b)(3)(A)(iii) of the Act \9\ and Rule 19b-4(f)(4) \10\
thereunder because the proposed rule effects a change in an existing
service of DTC that (i) does not adversely affect the safeguarding of
securities or funds in the custody or control of DTC or for which it is
responsible and (ii) does not significantly affect the respective
rights or obligations of DTC or persons using the service. At any time
within sixty days of the filing of the proposed rule change, the
Commission may summarily abrogate 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.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \10\ 17 CFR 240.19b-4(f)(4).
---------------------------------------------------------------------------

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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-DTC-2006-09 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-DTC-2006-09. This file
number should be included on the subject line if e-mail 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 inspection and
copying in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549. Copies of such filing also will be available
for inspection and copying at the principal office of DTC and on DTC's
Web site at http://www.dtc.org. 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-DTC-2006-09 and should be submitted on or before
September 22, 2006.

    For the Commission by the Division of Market Regulation,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
 [FR Doc. E6-14552 Filed 8-31-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 218 (Tuesday, November 16, 2021)]
[Notices]
[Pages 63401-63402]
[FR Doc No: 2021-24973]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1992-N-0011]

Sanyasi Raju Kalidindi; Grant of Special Termination

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has issued an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) granting
special termination of the debarment of Sanyasi Raju Kalidindi. FDA
based the order on a finding that Dr. Kalidindi provided substantial
assistance in the investigations or prosecutions of offenses relating
to a matter under FDA's jurisdiction and that terminating Dr.
Kalidindi's debarment served the interest of justice and protected the
integrity of the drug approval process.

DATES: The order became effective September 15, 2021.

ADDRESSES: Comments should reference Docket No. FDA-1992-N-0011 and be
sent to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Karena Cooper, Office of Scientific
Integrity, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 1, Rm. 4218, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In a Federal Register notice dated April 21,
1993 (58 FR 21470), FDA debarred Dr. Kalidindi from providing services
in any capacity to a person with an approved or pending drug product

application under section 306(a) of the FD&C Act (21 U.S.C. 335a(a)).
FDA based the debarment on a finding under section 306(a)(2) of the
FD&C Act that Dr. Kalidindi had been convicted of a felony under
Federal law for conduct relating to the development, or approval, of
any drug product or otherwise relating to the regulation of a drug
product.
    Section 306(d)(4) of the FD&C Act provides that any individual
debarred under section 306(a)(2) may apply to FDA for special
termination of debarment. Pursuant to section 306(d)(4)(C)-(D), FDA may
grant a request for special termination and limit the period of
debarment to less than permanent but no less than 1 year if the Agency
finds: (1) That the individual has provided substantial assistance in
the investigations or prosecutions of offenses described in section
306(a) or (b) of the FD&C Act, or relating to any matter under the
jurisdiction of FDA and (2) that doing so best serves the interest of
justice and protects the integrity of the drug approval process.
    On May 27, 1998, FDA denied a previous petition for special
termination of debarment submitted by Dr. Kalidindi. On January 13,
2020, Dr. Kalidindi again petitioned for special termination of
debarment under section 306(d)(4) of the FD&C Act. On April 10, 2020,
FDA's Office of Regulatory Affairs proposed denying that petition and
offered Dr. Kalidindi an opportunity to request a hearing on the
proposal to deny the petition. On May 9, 2020, Dr. Kalidindi requested
a hearing and, on June 8, 2020, submitted materials in support of his
hearing request.
    By a decision dated September 15, 2021, FDA's Chief Scientist
granted Dr. Kalidindi's petition for special termination based on her
conclusion that doing so best served the interest of justice and
protected the integrity of the drug approval process. In so concluding,
she found that there were no genuine and substantial issues of fact
with respect to the level and scope of substantial assistance provided
by Dr. Kalidindi in the investigation and prosecution of others for
offenses described in section 306(a) or (b) of the FD&C Act, or
otherwise relating to FDA's jurisdiction, and that the level and scope
of such substantial assistance, among other considerations, justified
special termination of his debarment after 28 years. The Chief
Scientist's decision is available at https://www.fda.gov/media/152270/download. The decision is also available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-debarment-list-drug-product-applications/fda-expired-debarment-list-drug-product-applications.

    Dated: November 4, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24973 Filed 11-15-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 82 (Monday, April 29, 2013)]
[Notices]
[Pages 25072-25074]
[FR Doc No: 2013-09969]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

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

    Docket Numbers: EC13-93-000.
    Applicants: Ameren Energy Generating Company, AmerenEnergy
Resources Generating Company, Ameren Energy Marketing Company, Electric
Energy, Inc., Midwest Electric Power, Inc., AmerenEnergy Medina Valley
Cogen, L.L.C., Dynegy Inc.
    Description: Joint Application for Authorization under Section 203
of the Federal Power Act and Request for Expedited Consideration of
Ameren Energy Generating Company, et al.
    Filed Date: 4/16/13.
    Accession Number: 20130416-5219.
    Comments Due: 5 p.m. ET 6/17/13.

    Docket Numbers: EC13-94-000.
    Applicants: NewPage Public Utilities, Franklin Resources, Inc.
    Description: Joint Application for Authorization under Section 203
of the Federal Power Act and Request for Expedited Consideration of
NewPage Public Utilities, and Franklin Resources, Inc.
    Filed Date: 4/16/13.
    Accession Number: 20130416-5221.
    Comments Due: 5 p.m. ET 5/7/13.

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

    Docket Numbers: ER10-2488-005; ER12-1931-002; ER10-2504-003; ER12-
610-003; ER12-2627-001; ER13-338-001.
    Applicants: Shiloh Wind Project 2, LLC, Pacific Wind Lessee, LLC,
Oasis Power Partners, LLC, Catalina Solar, LLC, Shiloh III Lessee, LLC,
Shiloh IV Lessee, LLC.
    Description: Supplement to December 31, 2012 Triennial Market Power
Analysis Update of the EDF Renewable Energy Inc. Southwest Region
Companies.
    Filed Date: 3/19/13.
    Accession Number: 20130319-5069.
    Comments Due: 5 p.m. ET 5/9/13.

    Docket Numbers: ER10-2794-010; ER10-2849-009; ER11-2028-010; ER12-
1825-008.
    Applicants: EDF Trading North America, LLC, EDF Industrial Power
Services (NY), LLC, EDF Industrial Power Services (IL), LLC, EDF
Industrial Power Services (CA), LLC.
    Description: Supplement to January 8, 2013 Updated Market Power
Analysis for the Southwest Region of EDF Trading North America, LLC, et
al.
    Filed Date: 3/21/13.
    Accession Number: 20130321-5007.
    Comments Due: 5 p.m. ET 5/9/13.

    Docket Numbers: ER10-2331-019; ER10-2343-019; ER10-2319-018; ER10-
2320-018; ER10-2317-017; ER10-2322-019; ER10-2324-018; ER10-2325-017;
ER10-2332-018; ER10-2326-019; ER10-2327-020; ER10-2328-018; ER11-4609-
017; ER10-2330-019.
    Applicants: J.P. Morgan Ventures Energy Corporation, J.P. Morgan
Commodities Canada Corporation, BE Alabama LLC, BE Allegheny LLC, BE
CA, BE Ironwood LLC, BE KJ LLC, BE Louisiana LLC, BE Rayle LLC, Cedar
Brakes I, L.L.C., Cedar Brakes II, L.L.C., Central Power & Lime LLC,
Triton Power Michigan LLC, Utility Contract Funding, L.L.C.
    Description: JPMorgan Sellers submit Notice of Non-Material Change
in Status re: Wildcat I.
    Filed Date: 4/16/13.
    Accession Number: 20130416-5222.
    Comments Due: 5 p.m. ET 5/7/13.

    Docket Numbers: ER10-3319-010; ER10-2964-003; ER11-2041-003; ER11-
2042-003; ER10-3193-002.
    Applicants: Brooklyn Navy Yard Cogeneration Partners, L.P., Astoria
Energy II LLC, Selkirk Cogen Partners, L.P., Innovative Energy Systems,
LLC, Seneca Energy II, LLC.
    Description: Amendment to April 4, 2013 Notification of Non-
material Change in Status of the NYISO Affiliates.
    Filed Date: 4/17/13.
    Accession Number: 20130417-5147.
    Comments Due: 5 p.m. ET 5/1/13.

    Docket Numbers: ER12-673-001; ER12-672-001; ER10-1908-002; ER10-
1909-002; ER10-1910-002; ER10-1911-002; ER10-1533-003; ER10-2374-002;
ER12-674-001; ER12-670-001.
    Applicants: Brea Generation LLC, Brea Power II, LLC, Duquesne
Conemaugh, LLC, Duquesne Keystone, LLC, Duquesne Light Company,
Duquesne Power, LLC, Macquarie Energy LLC, Puget Sound Energy, Inc.,
Rhode Island Engine Genco LLC, Rhode Island LFG Genco, LLC.
    Description: Notice of Non-Material Change in Status of Brea
Generation LLC, et al.
    Filed Date: 4/16/13.

    Accession Number: 20130416-5231.
    Comments Due: 5 p.m. ET 5/7/13.

    Docket Numbers: ER13-629-002.
    Applicants: Public Service Company of Colorado.
    Description: 2013-04-17-NSP-BNGR-Tran-to Load-542 to be effective
1/1/2013.
    Filed Date: 4/17/13.
    Accession Number: 20130417-5102.
    Comments Due: 5 p.m. ET 5/8/13.

    Docket Numbers: ER13-663-002.
    Applicants: Public Service Company of Colorado.
    Description: 2013-04-16-NSP-MDEU-Tran-to Load-541 to be effective
1/1/2013.
    Filed Date: 4/16/13.
    Accession Number: 20130416-5211.
    Comments Due: 5 p.m. ET 5/7/13.

    Docket Numbers: ER13-1085-001.
    Applicants: BE Alabama LLC.
    Description: Amendment to revision to market-based rate schedule to
be effective 4/17/2013.
    Filed Date: 4/16/13.
    Accession Number: 20130416-5206.
    Comments Due: 5 p.m. ET 5/7/13.

    Docket Numbers: ER13-1086-001.
    Applicants: BE Allegheny LLC.
    Description: Amendment to revisions to market-based rate tariff to
be effective 4/17/2013.
    Filed Date: 4/16/13.
    Accession Number: 20130416-5207.
    Comments Due: 5 p.m. ET 5/7/13.

    Docket Numbers: ER13-1087-001.
    Applicants: BE CA LLC.
    Description: Amendment to revisions to market-based rate tariff to
be effective 4/18/2013.
    Filed Date: 4/17/13.
    Accession Number: 20130417-5037.
    Comments Due: 5 p.m. ET 5/8/13.

    Docket Numbers: ER13-1089-001.
    Applicants: BE Ironwood LLC.
    Description: Amendment to revisions to market-based rate tariff to
be effective 4/17/2013.
    Filed Date: 4/16/13.
    Accession Number: 20130416-5209.
    Comments Due: 5 p.m. ET 5/7/13.

    Docket Numbers: ER13-1090-001.
    Applicants: BE KJ LLC.
    Description: Amendment to revisions to market-based rate tariff to
be effective 4/18/2013.
    Filed Date: 4/17/13.
    Accession Number: 20130417-5041.
    Comments Due: 5 p.m. ET 5/8/13.

    Docket Numbers: ER13-1097-001.
    Applicants: Central Power & Lime LLC.
    Description: Amendment to revisions to market-based rate tariff to
be effective 4/18/2013.
    Filed Date: 4/17/13.
    Accession Number: 20130417-5044.
    Comments Due: 5 p.m. ET 5/8/13.

    Docket Numbers: ER13-1098-001.
    Applicants: BE Rayle LLC.
    Description: Amendment to revisions to market-based rate tariff to
be effective 4/18/2013.
    Filed Date: 4/17/13.
    Accession Number: 20130417-5137.
    Comments Due: 5 p.m. ET 5/8/13.

    Docket Numbers: ER13-1099-001.
    Applicants: Triton Power Michigan LLC.
    Description: Amendment to revisions to market-based rate tariff to
be effective 4/18/2013.
    Filed Date: 4/17/13.
    Accession Number: 20130417-5146.
    Comments Due: 5 p.m. ET 5/8/13.

    Docket Numbers: ER13-1139-001.
    Applicants: Imperial Valley Solar 1, LLC.
    Description: Supplement to MBR Application to be effective 3/22/
2013.
    Filed Date: 4/17/13.
    Accession Number: 20130417-5181.
    Comments Due: 5 p.m. ET 5/8/13.

    Docket Numbers: ER13-1296-001.
    Applicants: Arizona Public Service Company.
    Description: WesConnect Point-to-Point Regional Transmission
Service Agreement to be effective 7/1/2013.
    Filed Date: 4/16/13.
    Accession Number: 20130416-5203.
    Comments Due: 5 p.m. ET 5/7/13.

    Docket Numbers: ER13-1300-000.
    Applicants: Tucson Electric Power Company.
    Description: WestConnect Point-to-Point Regional Transmission
Tariff to be effective 7/1/2013.
    Filed Date: 4/16/13.
    Accession Number: 20130416-5200.
    Comments Due: 5 p.m. ET 5/7/13.

    Docket Numbers: ER13-1301-000.
    Applicants: Southwest Power Pool, Inc.
    Description: 1313R7 Oklahoma Gas and Electric Company NITSA and NOA
to be effective 4/1/2013.
    Filed Date: 4/16/13.
    Accession Number: 20130416-5208.
    Comments Due: 5 p.m. ET 5/7/13.

    Docket Numbers: ER13-1302-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Queue Position No. V3-015--Original Service Agreement
No. 3525 to be effective 4/3/2013.
    Filed Date: 4/17/13.
    Accession Number: 20130417-5042.
    Comments Due: 5 p.m. ET 5/8/13.

    Docket Numbers: ER13-1303-000.
    Applicants: Utility Bid USA, LLC.
    Description: Utility Bid USA, LLC Market Based Rate Tariff to be
effective 5/15/2013.
    Filed Date: 4/17/13.
    Accession Number: 20130417-5149.
    Comments Due: 5 p.m. ET 5/8/13.

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

    Docket Numbers: ES13-20-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Application of Southwest Power Pool, Inc. Under
Section 204 of the Federal Power Act for an Order Authorizing the
Issuance of Securities.
    Filed Date: 4/16/13.
    Accession Number: 20130416-5220.
    Comments Due: 5 p.m. ET 5/7/13.

    Docket Numbers: ES13-21-000.
    Applicants: DTE Electric Company.
    Description: Application of DTE Electric Company for Authorization
to Issue Short-term Debt Securities.
    Filed Date: 4/17/13.
    Accession Number: 20130417-5003.
    Comments Due: 5 p.m. ET 5/8/13.

    Take notice that the Commission received the following open access
transmission tariff filings:

    Docket Numbers: OA07-37-006.
    Applicants: Louisville Gas & Electric Company, Kentucky Utilities
Company.
    Description: Louisville Gas and Electric Company, et al. submits
annual compliance report on unreserved use and late study penalty
assessments and distributions.
    Filed Date: 4/17/13.
    Accession Number: 20130417-5101.
    Comments Due: 5 p.m. ET 5/8/13.

    Docket Numbers: OA07-54-011.
    Applicants: PacifiCorp.
    Description: PacifiCorp's annual informational filing on
assessments and distributions of operational penalties.
    Filed Date: 04/17/2013.
    Accession Number: 20130417-5115.
    Comment Date: 5 p.m. ET 5/8/13.

    Docket Numbers: OA08-96-007.
    Applicants: Southern Company Services, Inc.
    Description: Southern Company Services, Inc. submits Report of
Penalty Assessments and Distribution in accordance with Orders Nos. 890
and 890-A and Compliance Report.
    Filed Date: 04/17/2013.
    Accession Number: 20130417-5208.
    Comment Date: 5 p.m. ET 5/8/13.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern

time on the specified comment date. Protests may be considered, but
intervention is necessary to become a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: April 18, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary..
[FR Doc. 2013-09969 Filed 4-26-13; 8:45 am].
BILLING CODE 6717-01-P