[Federal Register Volume 86, Number 189 (Monday, October 4, 2021)]
[Rules and Regulations]
[Pages 54600-54602]
[FR Doc No: 2021-21475]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0152; Airspace Docket No. 21-AGL-2]
RIN 2120-AA66

Amendment of J-107, J-515, and V-181; Establishment of T-407; and
Revocation of the Humboldt, MN, Domestic Low Altitude Reporting Point;
Northcentral United States

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Jet Routes J-107 and J-515, and VHF
Omnidirectional Range (VOR) Federal Airway V-181; establishes low
altitude Area Navigation (RNAV) route, T-407; and revokes the Humboldt,
MN, Domestic Low Altitude Reporting Point, in the northcentral United
States. This action is necessary due to the planned decommissioning of
the VOR portion of the Humboldt, MN, VOR/Tactical Air Navigation
(VORTAC). The Humboldt VOR, which provides navigation guidance to
portions of the affected Air Traffic Service (ATS) routes, is being
decommissioned as part of the FAA's VOR Minimum Operational Network
(VOR MON) program.

DATES: Effective date 0901 UTC, December 2, 2021. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11
and publication of conforming amendments.

ADDRESSES: FAA Order JO 7400.11F, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Rules and Regulations Group, Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591;
telephone:<PHONE_NUMBER>. The Order is also available for inspection
at the National Archives and Records Administration (NARA). For
information on the availability of FAA Order JO 7400.11F at NARA,
email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Jesse Acevedo, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it modifies the air traffic service route structure as
necessary to preserve the safe and efficient flow of air traffic within
the National Airspace System.

History

    The FAA published a notice of proposed rulemaking for Docket No.
FAA-2020-0152, in the Federal Register (86 FR 13668; March 10, 2021),
amending J-107, J-515, and V-181; establishing T-407; and revoking the
Humboldt reporting point. The proposed amendment, establishment, and
revocation actions were due to the planned decommissioning of the VOR
portion of the Humboldt, MN, VORTAC navigational aid. Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal. Two comments were
received, but were determined to be not substantive to this proposal.
    United States Jet Routes, VOR Federal airways, RNAV T-routes, and
Domestic Low Altitude Reporting points are published in paragraphs
2004, 6010(a), 6011, and 7001, respectively, of FAA Order JO 7400.11F,
dated August 10, 2021, and effective September 15, 2021, which are
incorporated by reference in 14 CFR 71.1. The ATS routes listed in this
document will be published subsequently in the Order.

Differences From NPRM

    In the NPRM published for Docket No. FAA-2020-0152, the FAA Order
JO 7400.11F paragraph number identified for VOR Federal Airways in the
regulatory text section listed ``2010(a)'' in error. The correct
paragraph number for VOR Federal Airways in the Order is ``6010(a)''
and is corrected in this rule.
    Additionally, the published NPRM mistakenly identified the ZOMTA
fix in the RNAV route T-407 in the regulatory text section with the
incorrect state of North Dakota (ND). The correct state is Minnesota
(MN). This rule corrects this editorial error. Further, the existing
ZOMTA fix, which is associated with the V-181 segment being removed in
this rule, is being redefined in the FAA's aeronautical database as the
ZOMTA waypoint (WP) at the same location. This ``fix'' to ``WP'' change
is also reflected in the T-407 route description in this rule.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order JO 7400.11F, Airspace Designations
and Reporting Points, dated August 10, 2021 and effective September 15,
2021. FAA Order JO 7400.11F is publicly available as listed in the
ADDRESSES section of this document. FAA Order JO 7400.11F lists Class
A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This action amends 14 CFR part 71 by modifying J-107, J-515, and V-
181; establishing T-407; and revoking the Humboldt reporting point. The
planned decommissioning of the VOR portion of the Humboldt, MN, VORTAC
has made this action necessary.
    The amendment actions are described below.
    J-107: J-107 extends between Los Angeles, CA, VORTAC and Sioux
Narrows, ON, Canada, VOR/DME. The portion within Canada is excluded.
This action removes the route segments between Dupree, SD, VOR/DME, and
Sioux Narrows, ON, Canada, VOR/DME, and removes the exclusionary
language. The resulting Jet Route now extends between Los Angeles, CA,
VORTAC and Dupree, SD, VOR/DME.
    J-515: J-515 extends between Fargo, ND, VOR/DME and the
intersection of the Humboldt, MN, VORTAC 356[deg] radial and United
States/Canadian border; and between Whitehorse, YT, Canada and the
Barrow, AK, VOR/DME. The airspace within Canada is excluded. This
action removes the route segment between the Fargo, ND, VOR/DME and the
intersection of the Humboldt, MN, VORTAC 356[deg] radial and United
States/Canadian border. As a result, the Jet Route now extends between
Whitehorse, YT, Canada, VOR/DME and Barrow, AK, VOR/DME.
    V-181: V-181 extends between Kirksville, MO, VORTAC, and the
intersection of the Humboldt, MN, VORTAC, 356[deg] radial and United
States/Canadian border. This action removes the route segment between
the Grand Forks, ND, VOR/DME and the intersection of the Humboldt, MN,
VORTAC, 356[deg] radial and United States/Canada border. As a result,
the airway now extends between the Kirksville, MO, VORTAC, and the
Grand Forks, ND, VOR/DME.
    T-407: T-407 is a new RNAV route that extends between the Sioux
Falls, SD, VORTAC and the ZOMTA, MN, WP, located at the United States/
Canadian border. This T-route overlies the current Federal airway V-181
from Sioux Falls, SD, VORTAC to the United States/Canadian border. The
existing ZOMTA fix, which is associated with the V-181 segment being
removed in this rule, is being redefined in the FAA's aeronautical
database as the ZOMTA waypoint (WP) at the same location. This ``fix''
to ``WP'' change is also reflected in the T-407 route description in
this rule.
    Humboldt: The Humboldt, MN, Domestic Low Altitude Reporting Point
is revoked.
    All of the navigational aid radials in the ATS route descriptions
below are stated in True degrees.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that will only affect air traffic
procedures and air navigation, it is certified that this rule, when
promulgated, does not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action of modifying Jet Routes J-
107 and J-515, VOR modifying Federal airway V-181, and establishing
RNAV route T-407, due to the planned decommissioning of the VOR portion
of the Humboldt, MN, VORTAC navigational aid, qualifies for two
categorical exclusions under the National Environmental Policy Act (42
U.S.C. 4321 et seq.) and its

implementing regulations at 40 CFR part 1500, and in accordance with
FAA Order 1050.1F, Environmental Impacts: Policies and Procedures. The
first is categorical exclusion 5-6.5a, which categorically excludes
from further environmental impact review rulemaking actions that
designate or modify classes of airspace areas, airways, routes, and
reporting points (see 14 CFR part 71, Designation of Class A, B, C, D,
and E Airspace Areas; Air Traffic Service Routes; and Reporting
Points). The second is categorical exclusion 5-6.5k, Publication of
existing air traffic control procedures that do not essentially change
existing tracks, create new tracks, change altitude, or change
concentration of aircraft on these tracks. As such, this action is not
expected to result in any potentially significant environmental
impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding
Extraordinary Circumstances, the FAA has reviewed this action for
factors and circumstances in which a normally categorically excluded
action may have a significant environmental impact requiring further
analysis. Accordingly, the FAA has determined that no extraordinary
circumstances exist that warrant preparation of an environmental
assessment or environmental impact study.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 is amended to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

Paragraph 2004 Jet Routes.

* * * * *

J-107 [Amended]

    From Los Angeles, CA; INT Los Angeles 083[deg] and Hector, CA,
226[deg] radials; Hector; Boulder City, NV; Milford, UT; Rock
Springs, WY; Muddy Mountain, WY; to Dupree, SD.
* * * * *

J-515 [Amended]

    From Whitehorse, YT, Canada; Northway, AK; Fairbanks, AK;
Bettles, AK; to Barrow, AK. The airspace within Canada is excluded.
* * * * *

Paragraph 6010(a) VOR Federal Airways.

* * * * *

V-181 [Amended]

    From Kirksville, MO; Lamoni, IA; Omaha, IA; Norfolk, NE;
Yankton, SD; Sioux Falls, SD; Watertown, SD; 34 miles, 24 miles, 34
MSL, Fargo, ND; to Grand Forks, ND.
* * * * *

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-407 Sioux Falls, SD (FSD) to ZOMTA, MN [New]

Sioux Falls, SD (FSD)             VORTAC            (Lat. 43[deg]38'58.14'' N, long. 096[deg]46'52.02'' W)
FFORT, SD                         WP                (Lat. 44[deg]58'47.45'' N, long. 097[deg]08'30.36'' W)
Fargo, ND (FAR)                   VOR/DME           (Lat. 46[deg]45'12.01'' N, long. 096[deg]51'04.75'' W)
Grand Forks, ND (GFK)             VOR/DME           (Lat. 47[deg]57'17.40'' N, long. 097[deg]11'07.33'' W)
WUBED, MN                         FIX               (Lat. 48[deg]43'30.50'' N, long. 097[deg]07'40.81'' W)
ZOMTA, MN                         WP                (Lat. 49[deg]00'00.00'' N, long. 097[deg]07'54.80'' W)

Paragraph 7001 Domestic Low Altitude Reporting Points.

* * * * *

Humboldt, MN [Removed]

* * * * *

    Issued in Washington, DC, on September 27, 2021.
Michael R. Beckles,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2021-21475 Filed 10-1-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 43 (Friday, March 4, 2022)]
[Notices]
[Page 12450]
[FR Doc No: 2022-04605]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL OP-OFA-006]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EIS)
Filed February 18, 2022 10 a.m. EST Through February 28, 2022 10 a.m.
EST
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

EIS No. 20220021, Draft, USFS, AK, Mendenhall Glacier Visitor Facility
Improvements, Comment Period Ends: 04/18/2022, Contact: Monique Nelson
907-209-4090.
EIS No. 20220022, Draft, USFS, OR, Ellis Integrated Vegetation Project,
Comment Period Ends: 04/18/2022, Contact: Leslie Taylor<PHONE_NUMBER>.
EIS No. 20220023, Final, USAF, TX, T-7A Recapitalization at Joint Base
San Antonio, Texas, Review Period Ends: 04/04/2022, Contact: Nolan
Swick<PHONE_NUMBER>.
EIS No. 20220024, Draft, BIA, NV, Chuckwalla Solar Projects, Comment
Period Ends: 04/18/2022, Contact: Chip Lewis<PHONE_NUMBER>.
EIS No. 20220025, Draft, FERC, OR, Lower Klamath Project, Comment
Period Ends: 04/18/2022, Contact: Office of External Affairs 866-208-
3372.
EIS No. 20220026, Final, FERC, UT, Delta Lateral Project, Review Period
Ends: 04/04/2022, Contact: Office of External Affairs<PHONE_NUMBER>.
EIS No. 20220027, Draft, RUS, WI, Badger State Solar Project, Comment
Period Ends: 04/18/2022, Contact: Peter Steinour<PHONE_NUMBER>.
EIS No. 20220028, Final Supplement, FHWA, NH, Newington-Dover, General
Sullivan Bridge Spaulding Turnpike Improvements Project, Contact:
Jamison Sikora<PHONE_NUMBER>.

    Under 23 U.S.C. 139(n)(2), FHWA has issued a single document that
consists of a final supplemental environmental impact statement and
supplemental record of decision. Therefore, the 30-day wait/review
period under NEPA does not apply to this action.

    Dated: February 28, 2022.
Cindy S. Barger,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2022-04605 Filed 3-3-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: February 1, 2006 (Volume 71, Number 21)]
[Notices]
[Page 5302]
[DOCID:fr01fe06-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP04-414-003]

Entrega Gas Pipeline LLC; Notice of Filing of Revised Tariff
Sheets

January 25, 2006.
    Take notice that on December 13, 2005, Entrega Gas Pipeline LLC
(Entrega) filed revised tariff sheets to its proposed FERC Gas Tariff,
Original Volume 1, in response to shipper concerns with respect to
Entrega's proposed tariff provisions relating to operational sales and
purchases of gas. Entrega states that its proposed tariff was filed in
compliance with Ordering Paragraph (B)(4) of the order issuing
certificates, issued by the Commission on August 9, 2005 in the
captioned docket.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed on or before the date as indicated below. Anyone filing a
protest must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

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

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

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on February 8, 2006.

Magalie R. Salas,
Secretary.
[FR Doc. E6-1261 Filed 1-31-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 137 (Wednesday, July 19, 2023)]
[Notices]
[Pages 46187-46188]
[FR Doc No: 2023-15217]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2013-0016]

Nemko North America, Inc.: Grant of Expansion of Recognition

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

ACTION: Notice.

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DATES: The expansion of the scope of recognition becomes effective on
July 19, 2023.

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, phone:<PHONE_NUMBER> or 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, phone:<PHONE_NUMBER> or email:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Notice of Final Decision

    OSHA hereby gives notice of the expansion of the scope of
recognition of Nemko North America, Inc. (NNA) as a NRTL. NNA requests
the addition of eight test standards to the NRTL scope of recognition.
    OSHA recognition of a NRTL signifies that the organization meets
the requirements specified in 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within the
scope of recognition. Each NRTL's scope of recognition includes (1) the
type of products the NRTL may test, with each type specified by the
applicable test standard; and (2) the recognized site(s) that has/have
the technical capability to perform the product-testing and product-
certification activities for test standards within the NRTL's scope.
Recognition is not a delegation or grant of government authority;
however, recognition enables employers to use products approved by the
NRTL to meet OSHA standards that require product testing and
certification.
    The agency processes an application by a NRTL for initial
recognition and for an expansion or renewal of this recognition,
following requirements in Appendix A, 29 CFR 1910.7. This appendix
requires that the agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides the preliminary finding. In the second notice,
the agency provides the final decision on the application. These
notices set forth the NRTL's scope of recognition or modifications of
that scope. OSHA maintains an informational web page for each NRTL,
including NNA, which details the NRTL's scope of recognition. These
pages are available from the OSHA website at http://www.osha.gov/dts/otpca/nrtl/index.html.
    NNA submitted an application on October 14, 2020 (OSHA-2013-0016-
0019), to expand the recognition to include ten additional test
standards. This application was revised on January 18, 2022 to remove
two standards from the original request. This expansion covers the
remaining eight standards. OSHA staff performed a detailed analysis of
the application packet and reviewed other pertinent information. OSHA
did not perform any on-site reviews in relation to this application.
    OSHA published the preliminary notice announcing NNA's expansion
application in the Federal Register on June 7, 2023 (88 FR 37286). The
agency requested comments by June 22, 2023, but it received no comments
in response to this notice. OSHA is now proceeding with this final
grant of expansion to NNA's NRTL scope of recognition.
    Docket No. OSHA-2013-0016 contains all materials in the record
concerning NNA's recognition. To obtain or review copies of all public
documents pertaining to NNA's expansion application, go to http://www.regulations.gov. All submissions, including copyrighted material,
are available for inspection through the OSHA Docket Office. Contact
the OSHA Docket Office at<PHONE_NUMBER> for assistance in locating
docket submissions.

II. Final Decision and Order

    OSHA staff examined NNA's expansion application, its capability to
meet the requirements of the test standards, and other pertinent
information. Based on its review of this evidence, OSHA finds that NNA
meets the requirements of 29 CFR 1910.7 for expansion of its
recognition, subject to the limitations and conditions listed in this
notice. OSHA, therefore, is proceeding with this final notice to grant
NNA's expanded scope of recognition. OSHA limits the expansion of NNA's
recognition to testing and certification of products for demonstration
of conformance to the test standards listed below in Table 1.

Table 1--Appropriate Test Standards for Inclusion in NNA's NRTL Scope of
                               Recognition
------------------------------------------------------------------------
        Test standard                     Test standard title
------------------------------------------------------------------------
UL 61010-2-010..............  Safety Requirements for Electrical
                               Equipment for Measurement, Control and
                               Laboratory Use--Part 2-010: Particular
                               Requirements for Laboratory Equipment for
                               the Heating of Materials.
UL 61010-2-020..............  Safety Requirements for Electrical
                               Equipment for Measurement, Control and
                               Laboratory Use--Part 2-020: Particular
                               Requirements for Laboratory Centrifuges.
UL 61010-2-091..............  Safety Requirements for Electrical
                               Equipment for Measurement, Control and
                               Laboratory Use--Part 2-091: Particular
                               Requirements for Cabinet X-Ray Systems.
UL 61010-2-030..............  Safety Requirements for Electrical
                               Equipment for Measurement, Control and
                               Laboratory Use--Part 2-030: Particular
                               Requirements for Equipment Having Testing
                               or Measuring Circuits.

UL 61010-031................  Safety Requirements for Electrical
                               Equipment for Measurement, Control and
                               Laboratory Use--Part 031: Safety
                               Requirements for Hand-Held and Hand-
                               Manipulated Probe Assemblies for
                               Electrical Test and Measurement.
UL 61010-2-051..............  Safety Requirements for Electrical
                               Equipment for Measurement, Control and
                               Laboratory Use--Part 2-051: Particular
                               Requirements for Laboratory Equipment for
                               Mixing and Stirring.
UL 61010-2-081..............  Safety Requirements for Electrical
                               Equipment for Measurement, Control and
                               Laboratory Use--Part 2-081: Particular
                               Requirements for Automatic and Semi-
                               Automatic Laboratory Equipment for
                               Analysis and Other Purposes.
UL 61010-2-101..............  Safety Requirements for Electrical
                               Equipment for Measurement, Control and
                               Laboratory Use--Part 2-101: Particular
                               Requirements for In Vitro Diagnostic
                               (IVD) Medical Equipment.
------------------------------------------------------------------------

    OSHA's recognition of any NRTL for a particular test standard is
limited to equipment or materials for which OSHA standards require
third-party testing and certification before using them in the
workplace. Consequently, if a test standard also covers any products
for which OSHA does not require such testing and certification, a
NRTL's scope of recognition does not include these products.

A. Conditions

    Recognition is contingent on continued compliance with 29 CFR
1910.7, including, but not limited to, abiding by the following
conditions of the recognition:
    1. NNA must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in its operations as a NRTL, and provide details of the
change(s);
    2. NNA must meet all the terms of its recognition and comply with
all OSHA policies pertaining to this recognition; and
    3. NNA must continue to meet the requirements for recognition,
including all previously published conditions on NNA's scope of
recognition, in all areas for which it has recognition.
    Pursuant to the authority in 29 CFR 1910.7, OSHA hereby expands the
scope of recognition of NNA as a NRTL, subject to the limitations and
conditions specified above.

III. Authority and Signature

    James S. Frederick, 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. 8-2020 (85 FR 58393,
Sept. 18, 2020), and 29 CFR 1910.7.

    Signed at Washington, DC, on July 12, 2023.
James S. Frederick,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2023-15217 Filed 7-18-23; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 81, Number 71 (Wednesday, April 13, 2016)]
[Rules and Regulations]
[Pages 21732-21735]
[FR Doc No: 2016-08352]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-4204; Directorate Identifier 2015-NM-001-AD;
Amendment 39-18482; AD 2016-08-06]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

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

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and
Model A300 C4-605R Variant F airplanes (collectively called Model A300-
600 series airplanes), modified by a particular supplemental type
certificate (STC). This AD was prompted by a report of chafing found on
the overflow sensor harness of the surge tank, and subsequent contact
between the electrical wiring and fuel tank structure. This AD requires
a one-time inspection for damage of the outer tank overflow sensor
harness, and repair if necessary. This AD also requires modification of
the sensor harness. We are issuing this AD to prevent chafing of the
harness and subsequent contact between the electrical wiring and fuel
tank structure, which could result in electrical arcing and a fuel tank
explosion.

DATES: This AD becomes effective May 18, 2016.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of May 18, 2016.

ADDRESSES: For service information identified in this final rule,
contact Simmonds Precision Products, Inc., A UTC Aerospace Company, 100
Panton Road, Vergennes, VT 05491; phone<PHONE_NUMBER>; fax<PHONE_NUMBER>;
Internet http://www.utcaerospacesystems.com. You may view this
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2015-4204.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
4204; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Office (telephone
800-647-5527) is Docket Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Marc Ronell, Aerospace Engineer,
Boston Aircraft Certification Office, ANE-150, FAA, 1200 District
Avenue, Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Airbus Model A300
B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R
Variant F airplanes (collectively called Model A300-600 series
airplanes), modified by a particular STC. The NPRM published in the
Federal Register on October 23, 2015 (80 FR 64371) (``the NPRM'').
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2013-0193, dated August 23, 2013 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all Airbus Model A300
series airplanes and all Model A300-600 series airplanes.
    The MCAI corresponds to FAA AD 2015-03-03, Amendment 39-18099 (80
FR 11101, March 2, 2015) (``AD 2015-03-03''), which applies to Airbus
Model A300 series airplanes and Model A300-600 series airplanes, all
serial numbers, except for airplanes modified by STC ST00092BO (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/D41C5AE8E46B4901862574900069E004?OpenDocument&Highlight=st00092bo).
    In AD 2015-03-03, we explained that airplanes that have had the in-
tank fuel quantity system modified by STC ST00092BO cannot accomplish
the actions required by AD 2015-03-03 by using Airbus Service Bulletin
A300-28-6109, Revision 01, dated December 20, 2013.
    We also stated that we were considering separate rulemaking to
require the procedures and compliance time specified in UTC Aerospace
Systems Service Bulletin 300723-28-03 (V-1577), dated October 10, 2014,
for airplanes modified by STC ST00092BO. We have determined that
further rulemaking is indeed necessary, and this AD follows from that
determination.
    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
4204.

Comments

    We gave the public the opportunity to participate in developing
this AD. We have considered the comments received. The following
presents the comments received on the NPRM and the FAA's response to
each comment.

Request To Extend Proposed Compliance Time

    FedEx asked that we extend the compliance time required by
paragraph (g) of the proposed AD from 12 to 30 months. FedEx stated
that AD 2015-03-03 required accomplishing the inspection and rerouting
within 30 months. FedEx added that, in both AD 2015-03-03 and the NPRM,
improper harness routing is the root cause of the issue, and stated
that airplanes having STC ST00092BO have equal susceptibility to
harness chafing damage as those identified in AD 2015-03-03. FedEx
suggested that a 30-month compliance time would still provide an
acceptable level of safety. FedEx added that it is expecting to wait
four to six months for one of the required materials, and the
availability of its installation tool has not been confirmed. FedEx
also stated that a longer compliance time would allow it to minimize
the operational impact and accomplish the potentially lengthy service
information at C-checks.
    We do not agree with the commenter's request to extend the
compliance time, because the request is not supported by any analysis
or supporting data. This compliance time is shorter to account for the
time already elapsed for airplanes having STC ST00092BO. In developing
an appropriate compliance time for the actions specified in this AD, we
considered the safety implications and normal maintenance schedules for
the timely accomplishment of the specified actions. We have determined
that the proposed 12-month compliance time will ensure an acceptable
level of safety and allow the actions to be done during scheduled
maintenance intervals for most affected operators. However, affected
operators may request an alternative method of compliance (AMOC) to
request an extension of the compliance time under the provisions of
paragraph (i) of this AD by submitting data and analysis substantiating
that the change would provide an acceptable level of safety. We have
not changed this AD in this regard.

Request To Increase Work Hour Estimate

    FedEx stated that, although the referenced service information
specifies 14 work-hours per airplane for accomplishing both actions,
the number of work-hours could be closer to 24, especially if a harness
is replaced.
    We infer that the commenter is requesting that the work-hour
estimate specified in the ``Costs of Compliance'' section be increased.
We partially agree with the request. We provided our best estimate for
the work hours based on the information received from the airplane
manufacturer and specified in the referenced service information.
However, we do not know the number of work-hours it would take to
replace a harness, and as stated in the ``Costs of Compliance''
section, we have received no definitive data that would enable us to
provide cost estimates for the on-condition actions. We have not
changed this final rule in this regard.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD as proposed except for minor editorial changes. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    UTC Aerospace Systems has issued Service Bulletin 300723-28-03 (V-
1577), Revision 01, dated July 20, 2015. The service information
describes procedures for an inspection for damage of the outer tank of
the overflow sensor harness, repair, and modification of the sensor
harness. This service information is reasonably available because the
interested parties have access to it through their normal course of
business

or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 65 airplanes of U.S. registry.
    We also estimate that it takes about 3 work-hours per product to
comply with the inspection required by this AD. The average labor rate
is $85 per work-hour. Based on these figures, we estimate the cost of
this inspection required by this AD on U.S. operators to be $16,575, or
$255 per product.
    We estimate that it takes about 11 work-hours per product to comply
with the modification requirements of this AD. The average labor rate
is $85 per work-hour. Required parts cost about $100 per product. Based
on these figures, we estimate the cost of this modification on U.S.
operators to be $67,275, or $1,035 per product.
    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2016-08-06 Airbus: Amendment 39-18482; Docket No. FAA-2015-4204;
Directorate Identifier 2015-NM-001-AD.

(a) Effective Date

    This AD becomes effective May 18, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the Airbus airplanes specified in paragraphs
(c)(1), (c)(2), (c)(3), and (c)(4) of this AD; certificated in any
category; modified by Simmonds Precision Products, Inc.,
Supplemental Type Certificate (STC) ST00092BO (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/D41C5AE8E46B4901862574900069E004?OpenDocument&Highlight=st00092bo).
    (1) Model A300 B4-601, B4-603, B4-620, and B4-622 airplanes.
    (2) Model A300 B4-605R and B4-622R airplanes.
    (3) Model A300 F4-605R and F4-622R airplanes.
    (4) Model A300 C4-605R Variant F airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel.

(e) Reason

    This AD was prompted by a report of chafing found on the
overflow sensor harness of the surge tank, and subsequent contact
between the electrical wiring and fuel tank structure. We are
issuing this AD to prevent chafing of the harness and subsequent
contact between the electrical wiring and fuel tank structure, which
could result in electrical arcing and a fuel tank explosion.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) One-Time Inspection and Repair

    Within 12 months after the effective date of this AD: Do the
actions required by paragraphs (g)(1), (g)(2), and (g)(3) of this
AD, in accordance with the Accomplishment Instructions of UTC
Aerospace Systems Service Bulletin 300723-28-03 (V-1577), Revision
01, dated July 20, 2015.
    (1) Perform a one-time general visual inspection for damage of
the outer tank sensor harness, and if any damage is found on the
expando sleeving, before further flight, do a detailed inspection of
the underlying wires for exposed conductor wires. If any exposed
conductor wire is found, before further flight, replace the outer
wing harness assembly.
    (2) Install new brackets and re-route the surge tank overflow
sensor harness.
    (3) Modify the harness protection.

(h) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(g) of this AD, if those actions were performed before the effective
date of this AD using UTC Aerospace Systems Service Bulletin 300723-
28-03 (V-1577), dated October 10, 2014. This service information is
not incorporated by reference in this AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Boston Aircraft Certification Office (ACO),
ANE-150, FAA, has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19. In accordance
with 14 CFR 39.19, send your request to your principal inspector or
local Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (j)(1) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(j) Related Information

    (1) For more information about this AD, contact Marc Ronell,
Aerospace Engineer, Boston Aircraft Certification Office, ANE-150,
FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-
7776; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (k)(3) and (k)(4) of this AD.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.

    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) UTC Aerospace Systems Service Bulletin 300723-28-03 (V-
1577), Revision 01, dated July 20, 2015.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Simmonds Precision Products, Inc., A UTC Aerospace Company, 100
Panton Road, Vergennes, VT 05491; phone<PHONE_NUMBER>; fax 802-877-
4444; Internet http://www.utcaerospacesystems.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on March 30, 2016.
Victor Wicklund,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-08352 Filed 4-12-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: February 9, 2010 (Volume 75, Number 26)]
[Notices]
[Page 6376-6377]
[DOCID:fr09fe10-54]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL10-38-000]

Kentucky Municipal Power Agency and Owensboro Municipal
Utilities, Complainants v. E.ON U.S. LLC, Respondent; Notice of
Complaint

February 2, 2010.
    Take notice that on January 29, 2010, pursuant to section 206 of
the Rules and Practice and Procedure of the Federal Energy Regulatory
Commission, 18 CFR 385.206 and section 206 of the Federal Power Act, 16
U.S.C. 824(e), Kentucky Municipal Power Agency and Owensboro Municipal
Utilities (Complainants) filed a formal complaint against E.ON U.S. LLC
(Respondent) requesting the Commission to either reject the
Respondent's proposed tariff change filed on November 20, 2009 in
Docket ER10-295-000 or suspend it and set it for hearing, in addition
to finding that the Respondent's business practice of rounding loses
up, but not down to the next whole MW is unreasonable.
    The Complainants state that a copy of the complaint has been served
on addressees on the official service list for Docket No. ER10-295.
There was no official listed for the Respondent itself on the
Commission's list of Corporate Officials. The complaint was served on
those listed for its affiliate LG&E Energy Corp.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the

``eFiling'' link at http://www.ferc.gov. Persons unable to file
electronically should submit an original and 14 copies of the protest
or intervention to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on February 18, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-2722 Filed 2-8-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: April 27, 2007 (Volume 72, Number 81)]
[Notices]
[Page 21059-21060]
[DOCID:fr27ap07-92]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55655; File No. SR-CBOE-2007-33]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change Amending Certain Exchange Rules, or Portions Thereof, Which
Have Been Determined by the Exchange to Be Obsolete, Outdated and/or
Unnecessary

April 23, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 4, 2007, the Chicago Board Options Exchange, Incorporated
(``CBOE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II below, which Items have been substantially prepared by
the Exchange. The Exchange filed the proposal pursuant to Section
19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(6) thereunder,\4\ which
renders the proposed rule change effective upon filing with the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    The Exchange proposes to amend certain Exchange rules, or portions
thereof, which have been determined by the Exchange to be obsolete,
outdated, and/or unnecessary. The text of the proposed rule change is
available on the Exchange's Web site (http://www.cboe.com/Legal), at

the Exchange's Office of the Secretary, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    The Exchange performed a complete review of CBOE rules, as well as
the surveillance procedures thereto, and identified a number of CBOE
rules, or portions thereof, that are outdated, obsolete, and/or
unnecessary. In conjunction with this review, this filing proposes to:
(i) Delete certain rules that are currently obsolete and are no longer
necessary; and (ii) amend certain rules that need to be updated.
Specifically, the Exchange proposes to delete or amend the following
CBOE rules:
Interpretation .01 of CBOE Rule 6.6
    This rule pertains to the procedures that are to be followed by the
Exchange when unusual market conditions exist. Specifically,
Interpretation .01 details the procedures that are to be followed in
the event there is an automatic suspension of the Exchange's Retail
Automatic Execution System (``RAES'') in an option class when a news
announcement pertaining to the underlying stock has been announced.
Pursuant to Interpretation .01, two Exchange floor officials are
notified promptly each time RAES is automatically suspended. This
filing proposes to revise Interpretation .01 to clarify that the two
Exchange floor officials are notified by senior help desk personnel.
The purpose for this revision is to make clear who notifies the floor
officials when an automatic suspension of RAES occurs.
CBOE Rule 6.58(a)
    CBOE Rule 6.58 pertains to the submission of certain trade
information to the Exchange by its members. Specifically, CBOE Rule
6.58(a) outlines the manner in which all trade information required by
CBOE Rule 6.51 \5\ is to be submitted to the Exchange. Currently, CBOE
Rule 6.51 already provides that all transactions shall be submitted to
the Exchange ``in a form and manner prescribed by the Exchange.'' Since
CBOE Rule 6.51 gives the Exchange the authority to prescribe the way
trade information and transactions shall be submitted to the Exchange,
there is no need to repeat this in CBOE Rule 6.58(a). Therefore, since
this language is duplicative with CBOE Rule 6.51, this filing proposes
to delete CBOE Rule 6.58(a).
---------------------------------------------------------------------------

    \5\ See CBOE Rule 6.51 which rule applies to Exchange member
reporting duties.
---------------------------------------------------------------------------

CBOE Rule 6.63
    CBOE Rule 6.63 involves the reporting of matched trades.
Specifically, this rule requires the Exchange to furnish certain
reports regarding daily trade information and trade settlement to the
Clearing Corporation each day. Paragraph (b) of Rule 6.63 states that
trades which are not submitted to the Clearing Corporation for
settlement shall be settled in accordance with the rules of the
Exchange. Currently, all trades that are executed on the Exchange are
submitted to the Clearing Corporation for settlement and the Exchange
does not nor does it plan in the future to settle any trades and will
continue to submit all trades to the Clearing Corporation for
settlement in accordance with Rule 6.63(a). Therefore, this filing
proposes to delete paragraph (b) of Rule 6.63.
CBOE Rule 8.11
    CBOE Rule 8.11 pertains to certain reporting requirements regarding
transactions for public customers. Specifically, this rule requires a
member organization to file ``such reports as the Exchange may require
of transactions for customers in classes of options contracts to which
such Market-Maker has been appointed.'' This rule was originally
implemented in the 1970s when the Exchange was first implemented and
the purpose of the rule was to keep the Exchange apprised of those
firms that were doing both market-maker activity and customer
transactions in the same products. This rule was implemented prior to
the Exchange maintaining electronic files on its members and such
information is now maintained electronically in the member
organization's membership database. Since such information is being
maintained electronically, the Exchange no longer requires member
organizations to file such reports.

Therefore, this filing proposes to delete CBOE Rule 8.11.
Interpretation .01 of CBOE Rule 15.5
    This rule pertains to financial reports that each Exchange member
is required to submit to the Exchange regarding certain financial
information that pertains to that Exchange member. Specifically,
Interpretation .01 states that an Exchange Market-Maker must submit to
the Exchange a monthly report of the use of his/her credit under
Section 220.4(g) of Regulation T of the Board of Governors of the
Federal Reserve System (``Regulation T''). Since Section 220.4(g) was
removed from Regulation T and therefore is no longer effective, this
filing proposes to delete this interpretation since the underlying
requirement from which it derived from no longer exists.
Interpretation .03 of Rule 15.5
    This filing proposes to add an interpretation to Rule 15.5 that
pertains to annual FOCUS filers to clarify how certain FOCUS filers may
file their annual FOCUS report with the Exchange. Specifically,
Interpretation .03 proposes to clarify that an Exchange member who
files an annual FOCUS report and who is not net capital computing has
the option to file the annual FOCUS report by (i) sending a hard copy
to the Exchange's Department of Member Firm Regulation (``DMFR'') or
(ii) filing it electronically with DMFR.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\6\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\7\ in particular, in that in
that it should promote just and equitable principles of trade, serve to
remove impediments to and perfect the mechanism of a free and open
market and a national market system, and in general, to protect
investors and the public interest.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange believes that the proposed rule change does not impose
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the foregoing proposed rule change does not:
    (i) Significantly affect the protection of investors or the public
interest;
    (ii) Impose any significant burden on competition; and
    (iii) Become operative for 30 days from the date on which it was
filed, or such shorter time as the Commission may designate if
consistent with the protection of investors and the public interest, it
has become effective pursuant to Section 19(b)(3)(A) of the Act,\8\ and
Rule 19b-4(f)(6) thereunder.\9\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6). The Commission notes that the
Exchange satisfied the pre-filing five-day notice requirement.
---------------------------------------------------------------------------

    At any time within 60 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.

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 e-mail to<EMAIL_ADDRESS>Please include File

Number SR-CBOE-2007-33 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-CBOE-2007-33. 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 Room. Copies of such
filing will also be available for inspection and copying at the
principal office of the Exchange. 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-CBOE-2007-33 and should be submitted by or before May
18, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-8056 Filed 4-26-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 78, Number 150 (Monday, August 5, 2013)]
[Notices]
[Page 47334]
[FR Doc No: 2013-18790]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4129-DR; Docket ID FEMA-2013-0001]

New York; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of New York (FEMA-4129-DR), dated July 12, 2013, and
related determinations.

DATES: Effective Date: July 26, 2013.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of New York is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of July 12, 2013.

    Broome, Chautauqua, Clinton, and Essex Counties for Public
Assistance.
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2013-18790 Filed 8-2-13; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 81, Number 144 (Wednesday, July 27, 2016)]
[Notices]
[Pages 49228-49230]
[FR Doc No: 2016-17750]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2153]

Use of Real-World Evidence to Support Regulatory Decisionmaking
for Medical Devices; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Use of Real-World
Evidence to Support Regulatory Decisionmaking for Medical Devices.''
FDA is issuing this draft guidance to clarify how we evaluate real-
world data (RWD) to determine whether it may be sufficiently relevant
and reliable to generate the types of real-world evidence that can be
used in regulatory decisionmaking for medical devices. This guidance
also clarifies when an

investigational device exemption (IDE) may be needed to prospectively
collect and use RWD for purposes of determining the safety and
effectiveness of a device. This draft guidance is not final nor is it
in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 25, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-2153 for ``Use of Real-World Evidence to Support Regulatory
Decisionmaking for Medical Devices.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Use of Real-World Evidence to Support Regulatory Decisionmaking for
Medical Devices'' to the Office of the Center Director, Guidance and
Policy Development, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Benjamin Eloff, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2254, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    To protect and promote the public health, FDA needs to understand
and evaluate the available evidence related to regulated products. For
medical devices, available evidence is traditionally comprised of non-
clinical and in some cases, clinical studies conducted and provided to
FDA by the device manufacturer or sponsor. However, FDA recognizes that
a wealth of data covering medical device experience exists and is
routinely collected in the course of treatment and management of
patients. Under certain circumstances, these RWD may be of sufficient
quality to help inform or augment FDA's understanding of the benefit-
risk profile of devices at various points in their life cycle, and
could potentially be used to aid FDA in regulatory decisionmaking.
    This document describes the characteristics and sources of RWD that
may be sufficient for use in making various regulatory decisions.
Because of its nature, the quality (i.e., relevance and reliability) of
RWD can vary greatly across sources. Likewise, there are many types of
regulatory decisions with varying levels of evidentiary needs. FDA's
evidentiary standards for regulatory decisionmaking are not changing;
FDA will evaluate whether the available RWD is of sufficient relevance
and reliability to address the specific regulatory decision being
considered.
    This guidance does not affect any federal, state or local laws or
regulations or foreign laws or regulations that may otherwise be
applicable to the use or collection of real-world evidence and that
provide protections for human subjects or patient privacy. When
finalized, this guidance should be used to complement, but not
supersede, other device-specific and good clinical practice guidance
documents.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Use of Real-
World Evidence to Support Regulatory Decisionmaking for Medical
Devices.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Use of Real-World Evidence
to Support Regulatory Decisionmaking for Medical Devices'' may send an
email request to<EMAIL_ADDRESS>to receive an electronic
copy of the document. Please use the document number 1500012 to
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations and guidance. These collections of
information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 807, subpart E
have been approved under OMB control number 0910-0120; the collections
of information in 21 CFR part 814, subparts A through E (premarket
approval) have been approved under OMB control number 0910-0231; the
collections of information in 21 CFR part 814, subpart H (humanitarian
device exemption) have been approved under OMB control number 0910-
0332; the collections of information in 21 CFR part 812
(investigational device exemption) have been approved under OMB control
number 0910-0078; the collections of information in 21 CFR part 822
(postmarket surveillance) have been approved under OMB control number
0910-0449; the collections of information in 21 CFR part 50.23
(exception from general requirements for informed consent) have been
approved under OMB control number 0910-0586; the collections of
information in 21 CFR part 54 (financial disclosure by clinical
investigators) have been approved under OMB control number 0910-0396;
the collections of information in 21 CFR part 56.115 (IRB records) have
been approved under OMB control number 0910-0130; and the collections
of information in 21 CFR parts 50 (informed consent) and 56 (IRBs) have
been approved under OMB control number 0910-0755. The collections of
information in the guidance ``Requests for Feedback on Medical Device
Submissions: The Pre-Submission Program and Meetings with Food and Drug
Administration Staff'' have been approved under OMB control number
0910-0756.

    Dated: July 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17750 Filed 7-26-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 131 (Friday, July 8, 2016)]
[Notices]
[Pages 44611-44614]
[FR Doc No: 2016-16200]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1233]

Use of Public Human Genetic Variant Databases To Support Clinical
Validity for Next Generation Sequencing-Based In Vitro Diagnostics;
Draft Guidance for Stakeholders and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Use of Public Human
Genetic Variant Databases to Support Clinical Validity for Next
Generation Sequencing (NGS)-Based In Vitro Diagnostics.'' This draft
guidance document describes how publicly accessible databases of human
genetic variants can serve as sources of valid scientific evidence to
support the clinical validity of genotype-phenotype relationships in
FDA's regulatory review of next generation sequencing (NGS)-based
tests. This draft guidance further outlines the process by which
administrators of genetic variant databases could voluntarily apply to
FDA for recognition, and how FDA would review such applications and
periodically reevaluate recognized databases. This draft guidance is
not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 6, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-1233 for ``Use of Public Human Genetic Variant Databases to
Support Clinical Validity for Next Generation Sequencing (NGS)-Based In
Vitro Diagnostics.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Use of Public Human Genetic Variant Databases to Support Clinical
Validity for Next Generation Sequencing (NGS)-Based In Vitro
Diagnostics'' to the Office of the Center Director, Guidance and Policy
Development, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002; or the Office of Communication, Outreach, and
Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Personalized Medicine Staff, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 4546, Silver Spring, MD 20993-
0002,<PHONE_NUMBER><EMAIL_ADDRESS>or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance document describes one part of FDA's effort to
create a flexible regulatory approach to the oversight of NGS-based
tests as part of the White House's Precision Medicine Initiative (PMI).
FDA held two workshops on this issue: ``Use of Databases for
Establishing the Clinical Relevance of Human Genetic Variants'' on
November 13, 2015, and ``Patient and Medical Professional Perspectives
on the Return of Genetic Test Results'' on March 2, 2016. The goal of
this effort is to help ensure patients receive accurate and meaningful
results, while promoting innovation in test development. This draft
guidance document describes how publicly accessible databases of human
genetic variants can serve as sources of valid scientific evidence to
support the clinical validity of genotype-phenotype relationships in
FDA's regulatory review of NGS-based tests. FDA is also issuing a draft
guidance entitled ``Use of Standards in FDA Regulatory Oversight of
Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used
for Diagnosing Germline Diseases'' which is being released concurrently
elsewhere in this issue of the Federal Register.
    NGS can enable rapid, broad, and deep sequencing of a portion of a
gene, entire exome(s), or a whole genome and may be used clinically for
a variety of diagnostic purposes, including risk prediction, diagnosis,
and treatment selection for a disease or condition. The rapid adoption
of NGS-based tests in both research and clinical practice is leading to
identification of an increasing number of genetic variants (e.g.,
pathogenic, benign, and of unknown significance), including rare
variants that may be unique to a single individual or family. This
draft guidance document describes FDA's considerations in determining
whether a genetic variant database is a source of valid scientific
evidence that could support the clinical validity of an NGS-based test.
This draft guidance further outlines the process by which
administrators of genetic variant databases could voluntarily apply to
FDA for recognition, and how FDA would review such applications and
periodically reevaluate recognized databases.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Use of
Public Human Genetic Variant Databases to Support Clinical Validity for
Next Generation Sequencing (NGS)-Based In Vitro Diagnostics.'' It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological

Health guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm and for Center for Biologics Evaluation and Research
guidance documents is available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of
``Use of Public Human Genetic Variant Databases to Support Clinical
Validity for Next Generation Sequencing (NGS)-Based In Vitro
Diagnostics'' may send an email request to<EMAIL_ADDRESS>to
receive an electronic copy of the document. Please use the document
number 16008 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Use of Public Human Genetic Variant Databases To Support Clinical
Validity for Next Generation Sequencing (NGS)-Based In Vitro
Diagnostics OMB Control Number 0910--NEW

    The draft guidance document ``Use of Public Human Genetic Variant
Databases to Support Clinical Validity for Next Generation Sequencing
(NGS)-Based In Vitro Diagnostics'' describes FDA's considerations in
determining whether a genetic variant database is a source of valid
scientific evidence that could support the clinical validity of an NGS-
based test. This draft guidance further outlines the process by which
administrators \1\ of genetic variant databases could voluntarily apply
to FDA for recognition, and how FDA would review such applications and
periodically reevaluate recognized databases. The draft guidance also
recommends that, at the time of recognition, the database administrator
make information regarding policies, procedures, and conflicts of
interest publicly available and accessible on the genetic variant
database's Web site.
---------------------------------------------------------------------------

    \1\ FDA acknowledges that many databases may not use the term
``administrator'' or may have a committee of individuals that
oversee the database. Therefore, for the purpose of this guidance, a
genetic variant database administrator is the entity or entities
that oversee database operations.
---------------------------------------------------------------------------

    Based on our experience and the nature of the information, we
estimate that it will take an average of 80 hours to complete and
submit an application for recognition. We estimate that maintenance of
recognition activities will take approximately one-fourth of that time
(20 hours) annually. We estimate that it will take approximately 1 hour
to post the information on the Web site.
    Respondents are administrators of genetic databases. Our estimate
of five respondents per year is based on the current number of
databases that may meet FDA recommendations for recognition and seek
such recognition.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application for recognition of genetic database....................               5                1                5               80              400
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of recognition activities..............................               5                1                5               20              100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                              Activity                                  Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Public disclosure of policies, procedures, and conflicts of                       5                1                5                1                5
 interest..........................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    This draft guidance also refers to previously approved collections
of information. These collections of information are subject to review
by the OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in the guidance document
``Requests for Feedback on Medical Device Submissions: The Pre-
Submission Program and Meetings with Food and Drug Administration
Staff'' have been approved under OMB control number 0910-0756. The
collections of information regarding premarket submissions have been
approved as follows: The collections of information in 21 CFR part 807,
subpart E, have been approved under OMB control number 0910-0120; and
the collections of information in 21 CFR part 814, subparts A through
E, have been approved under OMB control number 0910-0231.

V. Other Issues for Consideration

    The Agency invites comments on the draft guidance document entitled
``Use of Public Human Genetic Variant Databases to Support Clinical
Validity for Next Generation Sequencing (NGS)-Based In Vitro
Diagnostics,'' in general, and on the following questions, in
particular:
    1. Should the quality recommendations outlined in the guidance
apply equally to databases of somatic variants and to germline
variants?
    2. While this document applies to NGS-based tests, FDA expects that
it may also be relevant to genetic tests that use other technologies
(e.g., polymerase chain reaction, Sanger sequencing, etc.). Are any
additional considerations necessary to support the use of these
databases in the premarket review of tests using technologies other
than NGS, should FDA decide to apply this approach more broadly in the
future?
    3. FDA recognizes that the evidence linking specific variants to
diseases or conditions will change over time, and as such, assertions
about those variants may also change. If an assertion regarding a
variant changes over time, how should FDA assess what regulatory
actions may be appropriate with respect to in IVDs supported by such
assertions? How often should FDA conduct ongoing review of an FDA-
recognized database?
    4. FDA notes that databases may have ``discordant calls'' with
other databases, where the assertions for a variant in each database
vary. While FDA believes that these discordant calls often arise
because one database has information the other does not and our
proposed policy will mitigate these issues over time; what, if any,
action should FDA take when it learns about discordant calls between
two databases with respect to database recognition or IVDs supported by
such calls in FDA-recognized databases?
    5. FDA has requested information regarding conflicts of interest
for curators and personnel of databases seeking FDA recognition. FDA
acknowledges that many personnel involved with variant curation and
interpretation may have some connection to NGS test developers. What
type of information should FDA collect and what policies should it
implement to mitigate such potential conflicts of interest in FDA-
recognized databases?

    Dated: July 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16200 Filed 7-7-16; 8:45 am]
 BILLING CODE 4164-01-P