[Federal Register Volume 75, Number 249 (Wednesday, December 29, 2010)]
[Notices]
[Pages 82142-82145]
[FR Doc No: 2010-32718]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2010-0373 (Notice No. 10-10)]

Information Collection Activities

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, PHMSA
invites comments on certain information collections pertaining to
hazardous materials transportation for which PHMSA intends to request
renewal from the Office of Management and Budget (OMB).

DATES: Interested persons are invited to submit comments on or before
February 28, 2011.

ADDRESSES: You may submit comments identified by the docket number
(PHMSA-2010-0373) by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Fax: 1-202-493-2251.
     Mail: Docket Operations, U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, Routing
Symbol M-30, 1200 New Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: To Docket Operations, Room W12-140 on the
ground floor of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Instructions: All submissions must include the agency name and
docket number or Regulation Identification Number (RIN) for this
notice. Internet users may access comments received by DOT at: http://www.regulations.gov. Note that comments received will be posted without
change to: http://www.regulations.gov including any personal
information provided.
    Requests for a copy of an information collection should be directed
to Steven Andrews or T. Glenn Foster, Standards and Rulemaking Division
(PHH-12), Pipeline and Hazardous Materials Safety Administration, 1200
New Jersey Avenue, SE., East Building, 2nd Floor, Washington, DC 20590-
0001, Telephone<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Steven Andrews or T. Glenn Foster,
Standards and Rulemaking Division (PHH-12), Pipeline and Hazardous
Materials Safety Administration, 1200 New Jersey Avenue, SE., East
Building, 2nd Floor, Washington, DC 20590-0001, Telephone (202) 366-
8553.

SUPPLEMENTARY INFORMATION: Section 1320.8(d), Title 5, Code of Federal
Regulations requires PHMSA to provide interested members of the public
and affected agencies an opportunity to comment on information
collection and recordkeeping requests. This notice identifies
information collection requests that PHMSA will be submitting to OMB
for renewal and extension. These information collections are contained
in 49 CFR 171.6 and the Hazardous Materials Regulations (HMR; 49 CFR
parts 171-180). PHMSA has revised burden estimates, where appropriate,
to reflect current reporting levels or adjustments based on changes in
proposed or final rules published since the information collections
were last approved. The following information is provided for each
information collection: (1) Title of the information collection,
including former title if a change is being made; (2) OMB control
number; (3) summary of the information collection activity; (4)
description of affected public; (5) estimate of total annual reporting
and recordkeeping burden; and (6) frequency of collection. PHMSA will
request a three-year term of approval for each information collection
activity and, when approved by OMB, publish a notice of the approval in
the Federal Register.
    PHMSA requests comments on the following information collections:
    Title: Requirements for Cargo Tanks.
    OMB Control Number: 2137-0014.
    Summary: This information collection consolidates and describes the
information collection provisions in parts 178 and 180 of the HMR
involving the manufacture, qualification, maintenance and use of all
specification cargo tank motor vehicles. It also includes the
information collection and recordkeeping requirements for persons who
are engaged in the manufacture, assembly, requalification and
maintenance of DOT specification cargo tank motor vehicles. The types
of information collected include:
    (1) Registration Statements: Cargo tank manufacturers and
repairers, and cargo tank motor vehicle assemblers are required to be
registered with DOT by furnishing information relative to their
qualifications to perform the functions in accordance with the HMR. The
registration statements are used to identify these persons in order for
DOT

to ensure that they possess the knowledge and skills necessary to
perform the required functions and they are performing the specified
functions in accordance with the applicable regulations.
    (2) Requalification and maintenance reports: These reports are
prepared by persons who requalify or maintain cargo tanks. This
information is used by cargo tank owners, operators and users, and DOT
compliance personnel to verify that the cargo tanks are requalified,
maintained and are in proper condition for the transportation of
hazardous materials.
    (3) Manufacturers' data reports, certificates and related papers:
These reports are prepared by cargo tank manufacturers and certifiers,
and are used by cargo tank owners, operators, users and DOT compliance
personnel to verify that a cargo tank motor vehicle was designed and
constructed to meet all requirements of the applicable specification.
    Affected Public: Manufacturers, assemblers, repairers,
requalifiers, certifiers and owners of cargo tanks.
    Annual Reporting and Recordkeeping Burden:
    Number of Respondents: 41,366.
    Total Annual Responses: 132,600.
    Total Annual Burden Hours: 101,507.
    Frequency of Collection: Periodically.
    Title: Hazardous Materials Incident Reports.
    OMB Control Number: 2137-0039.
    Summary: This collection is applicable upon occurrence of incidents
as prescribed in Sec. Sec.  171.15 and 171.16. A Hazardous Materials
Incident Report, DOT Form F 5800.1, must be completed by a person in
physical possession of a hazardous material at the time a hazardous
material incident occurs in transportation, such as a release of
materials, serious accident, evacuation or closure of a main artery.
Incidents meeting criteria in Sec.  171.15 also require a telephonic
report. This information collection enhances the Department's ability
to evaluate the effectiveness of its regulatory program, determine the
need for regulatory changes, and address emerging hazardous materials
transportation safety issues. The requirements apply to all interstate
and intrastate carriers engaged in the transportation of hazardous
materials by rail, air, water, and highway.
    Affected Public: Shippers and carriers of hazardous materials.
    Annual Reporting and Recordkeeping Burden:
    Number of Respondents: 1,781.
    Total Annual Responses: 17,810.
    Total Annual Burden Hours: 23,746.
    Frequency of collection: On occasion.
    Title: Radioactive (RAM) Transportation Requirements.
    OMB Control Number: 2137-0510.
    Summary: This information collection consolidates and describes the
information collection provisions in the HMR involving the
transportation of radioactive materials in commerce. Information
collection requirements for RAM include: Shipper notification to
consignees of the dates of shipment of RAM; expected arrival; special
loading/unloading instructions; verification that shippers using
foreign-made packages hold a foreign competent authority certificate
and verification that the terms of the certificate are being followed
for RAM shipments being made into this country; and specific handling
instructions from shippers to carriers for fissile RAM, bulk shipments
of low specific activity RAM and packages of RAM which emit high levels
of external radiation. These information collection requirements help
to establish that proper packages are used for the type of radioactive
material being transported; external radiation levels do not exceed
prescribed limits; and packages are handled appropriately and delivered
in a timely manner, so as to ensure the safety of the general public,
transport workers, and emergency responders.
    Affected Public: Shippers and carriers of radioactive materials in
commerce.
    Annual Reporting and Recordkeeping Burden:
    Number of Respondents: 3,817.
    Total Annual Responses: 21,519.
    Total Annual Burden Hours: 15,270.
    Frequency of collection: On occasion.
    Title: Flammable Cryogenic Liquids.
    OMB Control Number: 2137-0542.
    Summary: Provisions in Sec.  177.840(a)(2) specify certain safety
procedures and documentation requirements for drivers of motor vehicles
transporting flammable cryogenic liquids. This information allows the
driver to take appropriate remedial actions to prevent a catastrophic
release of the flammable cryogenics should the temperature of the
material begin to rise excessively or if the travel time will exceed
the safe travel time. These requirements are intended to ensure a high
level of safety when transporting flammable cryogenics due to their
extreme flammability and high compression ratio when in a liquid state.
    Affected Public: Carriers of cryogenic materials.
    Annual Reporting and Recordkeeping Burden:
    Total Respondents: 65.
    Total Annual Responses: 18,200.
    Total Annual Burden Hours: 1,213.
    Frequency of collection: On occasion.
    Title: Rail Carrier and Tank Car Tank Requirements.
    OMB Control Number: 2137-0559.
    Summary: This information collection consolidates and describes the
information provisions in parts 172, 173, 174, 179, and 180 of the HMR
on the transportation of hazardous materials by rail and the
manufacture, qualification, maintenance and use of tank cars. The types
of information collected include:
    (1) Approvals of the Association of American Railroads (AAR) Tank
Car committee: An approval is required from the AAR Tank Car Committee
for a tank car to be used for a commodity other than those specified in
part 173 and on the certificate of construction. This information is
used to ascertain whether a commodity is suitable for transportation in
a tank car. AAR approval also is required for an application for
approval of designs, materials and construction, conversion or
alteration of tank car tanks constructed to a specification in part 179
or an application for construction of tank cars to any new
specification. This information is used to ensure that the design,
construction or modification of a tank car or the construction of a
tank car to a new specification is performed in accordance with the
applicable requirements.
    (2) Progress Reports: Each owner of a tank car that is required to
be modified to meet certain requirements specified in Sec.  173.31 must
submit a progress report to the Federal Railroad Administration (FRA).
This information is used by FRA to ensure that all affected tank cars
are modified before the regulatory compliance date.
    (3) FRA Approvals: An approval is required from FRA to transport a
bulk packaging (such as a portable tank, IM portable tank, intermediate
bulk container, cargo tank, or multi-unit tank car tank) containing a
hazardous material in container-on-flat-car or trailer-on-flat-car
service other than as authorized by Sec.  174.63. FRA uses this
information to ensure that the bulk package is properly secured using
an adequate restraint system during transportation. Also an FRA
approval is required for the movement of any tank car that does not
conform to the applicable requirements in the HMR. These latter
movements are currently being reported under the information collection
for special permit applications.
    (4) Manufacturer Reports and Certificate of Construction: These
documents are prepared by tank car manufacturers and used by owners,

users and FRA personnel to verify that rail tank cars conform to the
applicable specification.
    (5) Quality Assurance Program: Facilities that build, repair, and
ensure the structural integrity of tank cars are required to develop
and implement a quality assurance program. This information is used by
the facility and DOT compliance personnel to ensure that each tank car
is constructed or repaired in accordance with the applicable
requirements.
    (6) Inspection Reports: A written report must be prepared and
retained for each tank car that is inspected and tested in accordance
with Sec.  180.509 of the HMR. Rail carriers, users, and the FRA use
this information to ensure that rail tank cars are properly maintained
and in safe condition for transporting hazardous materials.
    Affected Public: Manufacturers, owners and rail carriers of tank
cars.
    Annual Reporting and Recordkeeping Burden:
    Number of Respondents: 266.
    Total Annual Responses: 16,782.
    Total Annual Burden Hours: 2,689.
    Frequency of collection: Annually.
    Title: Container Certification Statement.
    OMB Control Number: 2137-0582.
    Summary: Shippers of explosives, in freight containers or transport
vehicles by vessel, are required to certify on shipping documentation
that the freight container or transport vehicle meets minimal
structural serviceability requirements. This requirement is intended to
ensure an adequate level of safety for transport of explosives aboard
vessel and ensure consistency with similar requirements in
international standards.
    Affected Public: Shippers of explosives in freight containers or
transport vehicles by vessel.
    Annual Reporting and Recordkeeping Burden:
    Annual Respondents: 650.
    Annual Responses: 890,000.
    Annual Burden Hours: 14,908.
    Frequency of collection: On occasion.
    Title: Hazardous Materials Public Sector Training and Planning
Grants.
    OMB Control Number: 2137-0586.
    Summary: Part 110 of 49 CFR sets forth the procedures for
reimbursable grants for public sector planning and training in support
of the emergency planning and training efforts of States, Indian tribes
and local communities to manage hazardous materials emergencies,
particularly those involving transportation. Sections in this part
address information collection and recordkeeping with regard to
applying for grants, monitoring expenditures, and reporting and
requesting modifications.
    Affected Public: State and local governments, Indian tribes.
    Annual Reporting and Recordkeeping Burden:
    Annual Respondents: 68.
    Annual Responses: 68.
    Annual Burden Hours: 5,290.
    Frequency of collection: On occasion.
    Title: Response Plans for Shipments of Oil.
    OMB Control Number: 2137-0591.
    Summary: In recent years, several major oil discharges damaged the
marine environment of the United States. Under authority of the Federal
Water Pollution Control Act, as amended by the Oil Pollution Act of
1990, PHMSA issued regulations in 49 CFR Part 130 that require
preparation of written spill response plans.
    Affected Public: Carriers that transport oil in bulk, by motor
vehicle or rail.
    Annual Reporting and Recordkeeping Burden:
    Annual Respondents: 8,000.
    Annual Responses: 8,000.
    Annual Burden Hours: 10,560.
    Frequency of collection: On occasion.
    Title: Hazardous Materials Security Plans.
    OMB Control Number: 2137-0612.
    Summary: To assure public safety, shippers and carriers must take
reasonable measures to plan and implement procedures to prevent
unauthorized persons from taking control of, or attacking, hazardous
materials shipments. Part 172 of the HMR requires persons who offer or
transport certain hazardous materials to develop and implement written
plans to enhance the security of hazardous materials shipments. The
security plan requirement applies to shipments of: (1) A highway route-
controlled quantity of a Class 7 (radioactive) material; (2) more than
25 kg (55 lbs) of a Division 1.1, 1.2, or 1.3 (explosive) material; (3)
more than 1 L (1.06 qt) per package of a material poisonous by
inhalation in hazard zone A; (4) a shipment of hazardous materials in a
bulk packaging with a capacity equal to or greater than 13,248 L (3,500
gal) for liquids or gases, or greater than 13.24 cubic meters (468
cubic feet) for solids; (5) a shipment that requires placarding; and
(6) select agents. Select agents are infectious substances identified
by CDC as materials with the potential to have serious consequences for
human health and safety if used illegitimately. A security plan will
enable shippers and carriers to reduce the possibility that a hazardous
materials shipment will be used as a weapon of opportunity by a
terrorist or criminal.
    Affected Public: Shippers and carriers of hazardous materials in
commerce.
    Annual Reporting and Recordkeeping Burden:
    Number of Respondents: 54,999.
    Total Annual Responses: 54,999.
    Total Annual Burden Hours: 427,719.
    Frequency of collection: On occasion.
    Title: Inspection and Testing of Meter Provers.
    OMB Control Number: 2137-0620.
    Summary: This information collection and recordkeeping burden is
the result of efforts to eliminate special permits that are no longer
needed and incorporate the use, inspection, and maintenance of
mechanical displacement meter provers (meter provers) used to check the
accurate flow of liquid hazardous materials into bulk packagings, such
as portable tanks and cargo tank motor vehicles, under the HMR. These
meter provers are used to ensure that the proper amount of liquid
hazardous materials is being loaded and unloaded involving bulk
packagings, such as cargo tanks and portable tanks. These meter provers
consist of a gauge and several pipes that always contain small amounts
of the liquid hazardous material in the pipes as residual material,
and, therefore, must be inspected and maintained in accordance with the
HMR to ensure they are in proper calibration and working order. These
meter provers are not subject to the specification testing and
inspection requirements in part 178. However, these meter provers must
be visually inspected annually and hydrostatic pressure tested every
five years in order to ensure they are properly working as specified in
Sec.  173.5a of the HMR. Therefore, this information collection
requires that:
    (1) Each meter prover must undergo and pass an external visual
inspection annually to ensure that the meter provers used in the flow
of liquid hazardous materials into bulk packagings are accurate and in
conformance with the performance standards in the HMR.
    (2) Each meter prover must undergo and pass a hydrostatic pressure
test at least every five years to ensure that the meter provers used in
the flow of liqiuid hazardous materials into bulk packagings are
accurate and in conformance with the performance standards in the HMR.
    (3) Each meter prover must successfully complete the test and
inspection and must be marked in accordance with Sec.  180.415(b) and
in accordance with Sec.  173.5a.
    (4) Each owner must retain a record of the most recent visual
inspection and

pressure test until the meter prover is requalified.
    Affected Public: Owners of meter provers used to measure liquid
hazardous materials flow into bulk packagings such as cargo tanks and
portable tanks.
    Annual Reporting and Recordkeeping Burden:
    Number of Respondents: 50.
    Total Annual Responses: 250.
    Total Annual Burden Hours: 175.
    Frequency of collection: On occasion.
    Title: Requirements for United Nations (UN) Cylinders.
    OMB Control Number: 2137-0621.
    Summary: This information collection and recordkeeping burden is
the result of efforts to amend the HMR to adopt standards for the
design, construction, maintenance and use of cylinders and multiple-
element gas containers (MEGCs) based on the standards contained in the
United Nations (UN) Recommendations on the Transport of Dangerous
Goods. Aligning the HMR with the UN Recommendations promotes
flexibility, permits the use of technological advances for the
manufacture of the pressure receptacles, provides for a broader
selection of pressure receptacles, reduces the need for special
permits, and facilitates international commerce in the transportation
of compressed gases. Information collection requirements address
domestic and international manufacturers of cylinders that request
approval by the approval agency for cylinder design types. The approval
process for each cylinder design type includes review, filing, and
recordkeeping of the approval application. The approval agency is
required to maintain a set of the approved drawings and calculations
for each design it reviews and a copy of each initial design type
approval certificate approved by the Associate Administrator for not
less than 20 years.
    Affected Public: Fillers, owners, users, and retesters of UN
cylinders.
    Annual Reporting and Recordkeeping Burden:
    Number of Respondents: 50.
    Total Annual Responses: 150.
    Total Annual Burden Hours: 900.
    Frequency of collection: On occasion.

    Issued in Washington, DC, on December 22, 2010.
Delmer F. Billings,
Acting Director, Standards and Rulemaking Division.
[FR Doc. 2010-32718 Filed 12-28-10; 8:45 am]
BILLING CODE 4910-60-P


The Motor Vehicle Manufacturing Industry Applying Aluminum Parts --

Leachable Antimony Data

Facility Name	City	State	Sample Date	Sample ID	Duplicate Indicator Constituent Name	Leachable Actual or Calculated	Analytical Method Leachable Result	Leachable Units	Leachable Non-Detect Indicator Leachable Detection Limit mg/L	Description

	Ford MI Truck/Wayne Integrated Stamping & Assembly	WAYNE	MI

Drum #1	N	antimony	actual

0.0088	mg/L

0.0446	The associated value is an estimated quantity.

GM Flint Truck	FLINT	MI

FT-2	N	antimony	actual

0.056	mg/L

	Estimate

GM Flint Truck	FLINT	MI

FT-5	N	antimony	actual

0.22	mg/L

	Estimate

GM Flint Truck	FLINT	MI

FT-6	N	antimony	actual

0.085	mg/L

	Estimate

GM Flint Truck	FLINT	MI

FT-7	N	antimony	actual

0.12	mg/L

	Estimate

GM Hamtramck Plant	DETROIT	MI

H1-2	N	antimony	actual

0.087	mg/L

	Estimate

GM Hamtramck Plant	DETROIT	MI

H1-3	N	antimony	actual

0.12	mg/L

	Estimate

GM Hamtramck Plant	DETROIT	MI

H1-5	N	antimony	actual

0.12	mg/L

	Estimate

GM Hamtramck Plant	DETROIT	MI

H1-7	N	antimony	actual

0.24	mg/L

	Estimate

GM Hamtramck Plant	DETROIT	MI

H2-2	N	antimony	actual

0.059	mg/L

	Estimate

GM Hamtramck Plant	DETROIT	MI

H2-3	N	antimony	actual

0.049	mg/L

	Estimate

GM Hamtramck Plant	DETROIT	MI

H2-4	N	antimony	actual

0.048	mg/L

	Estimate

GM Hamtramck Plant	DETROIT	MI

H2-7	N	antimony	actual

0.051	mg/L

	Estimate

GM Lansing Assembly Center	LANSING	MI	12/19/1997	LAN-S01-01	N	antimony actual	Method 6020	0.015	mg/L

	GM Lansing Assembly Center	LANSING	MI	12/19/1997	LAN-S01-02	N	antimony actual	Method 6020	0.021	mg/L

	GM Lansing Assembly Center	LANSING	MI	12/19/1997	LAN-S01-03	N	antimony actual	Method 6020	0.02	mg/L

	GM Lansing Assembly Center	LANSING	MI	1/29/1998	LAN-S02-01	N	antimony actual	Method 6020	0.017	mg/L

	One of the two OWEP metals results was non-detect (TCLP or soxhlet).  The detection level was used in the calculation to be conservative.

GM Lansing Assembly Center	LANSING	MI	1/29/1998	LAN-S02-02	N	antimony actual	Method 6020	0.053	mg/L

	One of the two OWEP metals results was non-detect (TCLP or soxhlet).  The detection level was used in the calculation to be conservative.

GM Lansing Assembly Center	LANSING	MI	1/29/1998	LAN-S02-03	N	antimony actual	Method 6020	0.017	mg/L

	One of the two OWEP metals results was non-detect (TCLP or soxhlet).  The detection level was used in the calculation to be conservative.

GM Lansing Assembly Center	LANSING	MI	10/15/2002	10738.01	N	antimony actual

0.01	mg/L

	GM Lansing Assembly Center	LANSING	MI	10/31/2002	10904.01	N	antimony actual

0.01	mg/L

	GM Lansing Assembly Center	LANSING	MI	12/6/2002	11327.01	N	antimony actual

0.02	mg/L

	GM Lansing Assembly Center	LANSING	MI	12/6/2002	11327.02	N	antimony actual

0.01	mg/L

	GM Lordstown Assembly Plant	LORDSTOWN	OH	12/16/1997	LOR-S01-01	N antimony	actual

0.015	mg/L

	One of the two OWEP metals results (TCLP or soxhlet) was non-detected. The OWEP concentration was calculated by assuming that the sample quantitation limit for the non-detected result was a worst-case contribution.

GM Lordstown Assembly Plant	LORDSTOWN	OH	12/16/1997	LOR-S01-02	N antimony	actual

0.015	mg/L

	One of the two OWEP metals results (TCLP or soxhlet) was non-detected. The OWEP concentration was calculated by assuming that the sample quantitation limit for the non-detected result was a worst-case contribution.

GM Lordstown Assembly Plant	LORDSTOWN	OH	12/16/1997	LOR-S01-03	N antimony	actual

0.013	mg/L

	One of the two OWEP metals results (TCLP or soxhlet) was non-detected. The OWEP concentration was calculated by assuming that the sample quantitation limit for the non-detected result was a worst-case contribution.

GM Lordstown Assembly Plant	LORDSTOWN	OH	12/16/1997	LOR-S01-04	N antimony	actual

0.017	mg/L

	One of the two OWEP metals results (TCLP or soxhlet) was non-detected. The OWEP concentration was calculated by assuming that the sample quantitation limit for the non-detected result was a worst-case contribution.

GM Oklahoma City	OKLAHOMA CITY	OK	12/16/1997	OKL-S01-01	N	antimony actual

0.004	mg/L

	One of the OWEP extractions was ND, final result conservatively calculated using the sample quantitation limit in the final calculation of mobile metals concentration.

GM Oklahoma City	OKLAHOMA CITY	OK	12/16/1997	OKL-S01-02	N	antimony actual

0.004	mg/L

	One of the OWEP extractions was ND, final result conservatively calculated using the sample quantitation limit in the final calculation of mobile metals concentration.

GM Oklahoma City	OKLAHOMA CITY	OK	12/16/1997	OKL-S01-03	N	antimony actual

0.005	mg/L

	GM Oklahoma City	OKLAHOMA CITY	OK	12/16/1997	OKL-S01-04	N	antimony actual

0.005	mg/L

	One of the OWEP extractions was ND, final result conservatively calculated using the sample quantitation limit in the final calculation of mobile metals concentration.

GM Pontiac East Plant	PONTIAC	MI

PE-1	N	antimony	actual

0.096	mg/L

	Estimate

GM Pontiac East Plant	PONTIAC	MI

PE-3	N	antimony	actual

0.086	mg/L

	Estimate

GM Pontiac East Plant	PONTIAC	MI

PE-4	N	antimony	actual

0.13	mg/L

	Estimate

GM Pontiac East Plant	PONTIAC	MI

PE-6	N	antimony	actual

0.29	mg/L

	Estimate

GM Pontiac East Plant	PONTIAC	MI

PE-7	N	antimony	actual

0.15	mg/L

	Estimate

n 	36

MAXIMUM	0.29

MEAN	0.0635222

MEDIAN	0.0345

Std. Dev.	0.0715116

	90th Percentile	0.14

50th Percentile	0.0345


[Federal Register Volume 79, Number 207 (Monday, October 27, 2014)]
[Proposed Rules]
[Pages 63882-63883]
[FR Doc No: 2014-25486]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 60

[EPA-HQ-OAR-2013-0602; FRL-9918-49-OAR]
RIN 2060-AR33

Carbon Pollution Emission Guidelines for Existing Stationary
Sources: Electric Utility Generating Units

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule; correction.

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

SUMMARY: The Environmental Protection Agency (EPA) published in the
Federal Register on September 25, 2014, an extending the comment period
for the proposed rule titled ``Carbon Pollution Emission Guidelines for
Existing Stationary Sources: Electric Utility Generating Units'' by 45
days. Inadvertently, that proposed rule included an incorrect digit in
the docket number for the proposed rule. This proposed rule corrects
that error.

DATES: This correction is effective on October 27, 2014.

FOR FURTHER INFORMATION CONTACT: Ms. Amy Vasu, Sector Policies and
Programs Division (D205-01), U.S. EPA, Research Triangle Park, NC
27711; telephone number<PHONE_NUMBER>, facsimile number (919) 541-
4991; email address<EMAIL_ADDRESS>or Ms. Marguerite McLamb, Sector
Policies and Programs Division (D205-01), U.S. EPA, Research Triangle
Park, NC 27711; telephone number<PHONE_NUMBER>, facsimile number (919)
541-4991; email address<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: The EPA published in the Federal Register on
September 25, 2014 (79 FR 57492), a proposed rule extending, by 45
days, the comment period for the proposed rule titled ``Carbon
Pollution Emission Guidelines for Existing Stationary Sources: Electric
Utility Generating Units.'' This proposed rule corrects an incorrect
docket number published on September 25, 2014.
    In FR Doc. 2014-22832, published on September 25, 2014 (79 FR
57492), in the first column of page 57492, correct the docket number
listed in the notice to read:
    Docket: The EPA has established the official public docket for this
rulemaking under Docket ID No. EPA-HQ-OAR-2013-0602.

    Dated: October 20, 2014.
Mary E. Henigin,
Acting Director for Office of Air Quality Planning and Standards.
[FR Doc. 2014-25486 Filed 10-24-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: January 13, 2006 (Volume 71, Number 9)]
[Notices]
[Page 2213-2216]
[DOCID:fr13ja06-76]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PF06-1-000]

CenterPoint Energy Gas Transmission; Notice of Intent To Prepare
an Environmental Impact Statement for the Proposed Carthage to
Perryville Project, Request for Comments on Environmental Issues, and
Notice of Public Scoping Meetings

January 6, 2006.
    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental impact statement (EIS) that
will address the environmental impacts of the Carthage to Perryville
Project proposed by CenterPoint Energy Gas Transmission (CEGT). The
Commission will use the EIS in its decisionmaking process to determine
whether or not to authorize the project. This notice explains the
scoping process we \1\ will use to gather input from the public and
interested agencies on the project. Your input will help us determine
the issues that need to be evaluated in the EIS. Please note that the
scoping period will close on February 10, 2006.
---------------------------------------------------------------------------

    \1\ ``We,'' ``us,'' and ``our'' refer to the environmental staff
of the FERC's Office of Energy Projects.
---------------------------------------------------------------------------

    Comments may be submitted in written form or verbally. Further
details on how to submit written comments are provided in the Public
Participation section of this notice. In lieu of sending written
comments, we invite you to attend the public scoping meetings we have
scheduled as follows:

------------------------------------------------------------------------
             Date and time                           Location
------------------------------------------------------------------------
Tuesday, January 24, 2006, 7 p.m. to 9   Texas Country Music Hall of
 p.m. (CST).                              Fame, 300 West Panola Street,
                                          Carthage, TX 75633. Telephone:
<PHONE_NUMBER>.
Wednesday, January 25, 2006, 7 p.m. to   Quitman High School Auditorium,
 9 p.m. (CST).                            181 Wolverine Drive, Quitman,
                                          LA 71268. Telephone: (318) 259-
                                          2698.
Thursday, January 26, 2006, 7 p.m. to 9  Delhi Civic Center, 232 Denver
 p.m. (CST).                              Street, Delhi, LA 71232.
                                          Telephone:<PHONE_NUMBER>.
------------------------------------------------------------------------

    This notice is being sent to affected landowners; Federal, State,
and local government agencies; elected officials; environmental and
public interest groups; Native American tribes; other interested
parties; and local libraries and newspapers. We encourage government
representatives to notify their constituents of this planned project
and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, you may be contacted
by a CEGT representative about the acquisition of an easement to
construct, operate, and maintain the proposed project facilities. The
pipeline company would seek to negotiate a mutually acceptable
agreement. However, if the project is approved by the FERC, that
approval conveys with it the right of eminent domain. Therefore, if
easement negotiations fail to produce an agreement, the pipeline
company could initiate condemnation proceedings in accordance with
State law.
    A fact sheet prepared by the FERC entitled ``An Interstate Natural
Gas Facility on My Land? What Do I Need To Know?'' is available for
viewing on the FERC Internet Web site (http://www.ferc.gov). This fact

sheet addresses a number of typically asked questions, including the
use of eminent domain and how to participate in the FERC's proceedings.

Summary of the Proposed Project

    CEGT proposes to construct, own, operate, and maintain a natural
gas pipeline to provide new pipeline capacity to transport domestic
onshore gas supplies from the Barnett Shale and Bossier Sand production
areas in eastern Texas, as well as the Elm Grove and Vernon Field
production areas in Louisiana. CEGT indicates that the proposed
facilities would facilitate the transport of natural gas to the Midwest
and Northeastern regions of the United States and help satisfy demand
in those markets. The proposed pipeline would originate from receipt
points near Carthage in Panola County, Texas, and extend to a terminus
at interconnections with four existing interstate pipelines located
within CEGT's Perryville Hub, near Delhi in Richland Parish, Louisiana.
The general location of the proposed pipeline is shown in the figure
included as Appendix 1.\2\
---------------------------------------------------------------------------

    \2\ The appendices referenced in this notice are not being
printed in the Federal Register. Copies of all appendices, other
than Appendix 1 (maps), are available on the Commission's Web site
at the ``eLibrary'' link or from the Commission's Public Reference
Room, 888 First Street, NE., Washington, DC 20426, or call (202)
502-8371. For instructions on connecting to eLibrary refer to the
Public Participation section of this notice. Copies of the
appendices were sent to all those receiving this notice in the mail.
Requests for detailed maps of the proposed facilities should be made
directly to CEGT.
---------------------------------------------------------------------------

    The Carthage to Perryville Project facilities under FERC
jurisdiction would include:
     171.6 miles of 42-inch-diameter natural gas pipeline in
Panola County, Texas, and Caddo, De Soto, Red River, Bienville,
Jackson, Ouachita, and Richland Parishes, Louisiana;
     Two compressor stations, the Panola and Vernon Compressor
Stations, located in Panola County, Texas, and Jackson Parish,
Louisiana, respectively (phased construction with initially installed
gas turbine-driven compression of 10,310 horsepower (hp) to be expanded
to 20,620 hp at each station by October 2008);
     Two meter and regulator stations at receipt points with
three intrastate pipelines, including:

--Energy Transfer Fuels Meter/Regulator Station in Panola County, Texas
--Duke Energy Field Services-Enbridge Meter/Regulator Station in Panola
County, Texas;

     Four new meter and regulator stations at interconnects
with existing interstate pipelines, including:

--Texas Gas Meter/Regulator Station in Ouachita Parish, Louisiana
--ANR Meter/Regulator Station in Richland Parish, Louisiana
--Trunkline Meter/Regulator Station in Richland Parish, Louisiana
--Columbia Gulf Meter/Regulator Station in Richland Parish, Louisiana;
and

     10 mainline valves.
    The project would be designed and constructed to receive and
transport about 1.2 billion cubic feet of natural gas per day. CEGT
proposes to have the project constructed and operational by February
2007.

Land Requirements for Construction

    As proposed, the typical construction right-of-way for the project
pipeline would be 100 feet wide. Following construction, CEGT would
retain a 60-foot-wide permanent right-of-way for operation of the
project. Additional, temporary extra workspaces beyond the typcial
construction right-of-way limits would be required at certain feature
crossings (e.g., roads, railroads, wetlands, or waterbodies), in areas
with steep side slopes, or in association with special construction
techniques.
    Based on preliminary information, construction of the proposed
project facilities would affect a total of about 2,398.4 acres of land.
Following construction, about 1,247.9 acres would be maintained as
permanent right-of-way, and about 56.8 acres of land would be
maintained as new aboveground facility sites. The remaining 1,093.7
acres of temporary workspace (including all temporary construction
rights-of-way, extra workspaces, and pipe storage and contractor yards)
would be restored and allowed to revert to its former use.

The EIS Process

    NEPA requires the Commission to take into account the environmental
impacts that could result from an action when it considers whether or
not an interstate natural gas pipeline should be approved. The FERC
will use the EIS to consider the environmental impact that could result
if the CEGT project is authorized under section 7 of the Natural Gas
Act. NEPA also requires us to discover and address concerns the public
may have about proposals to be considered by the Commission. This
process is referred to as ``scoping.'' The main goal of the scoping
process is to focus the analysis in the EIS on the important
environmental issues. With this Notice of Intent, the Commission staff
is requesting public comments on the scope of the issues to be
addressed in the EIS. All comments received will be considered during
preparation of the EIS.
    In the EIS we will discuss impacts that could occur as a result of
the construction and operation of the proposed project under these
general headings:

     Geology and soils;
     Water resources;
     Wetlands and vegetation;
     Fish and wildlife;
     Threatened and endangered species;
     Land use, recreation, and visual resources;
     Air quality and noise;
     Cultural resources;
     Socioeconomics;
     Reliability and safety; and
     Cumulative impacts.
    In the EIS, we will also evaluate possible alternatives to the
proposed project or portions of the project, and make recommendations
on how to lessen or avoid impacts on affected resources.
    Our independent analysis of the issues will be included in a draft
EIS. The draft EIS will be mailed to Federal, State, and local
government agencies; elected officials; environmental and public
interest groups; Native American tribes; affected landowners;
commentors; other interested parties; local libraries and newspapers;
and the FERC's official service list for this proceeding. A 45-day
comment period will be allotted for review of the draft EIS. We will
consider all comments on the draft EIS and revise the document, as
necessary, before issuing a final EIS. We will consider all comments on
the final EIS before we make our recommendations to the Commission. To
ensure that your comments are considered, please follow the
instructions in the Public Participation section of this notice.
    Although no formal application has been filed, the FERC staff has
already initiated its NEPA review under its NEPA Pre-filing Process.
The purpose of the Pre-filing Process is to encourage the early
involvement of interested stakeholders and to identify and resolve
issues before an application is filed with the FERC.
    With this notice, we are asking Federal, State, and local
governmental agencies with jurisdiction and/or special expertise with
respect to environmental issues, especially those identified in
Appendix 2, to express their interest in becoming cooperating agencies
for the preparation of the EIS. These agencies may choose to
participate once they have evaluated the proposal relative to their
responsibilities. Agencies that would like to request cooperating
status should follow the instructions for filing comments provided in
Appendix 2.

Currently Identified Environmental Issues

    The EIS will discuss impacts that could occur as a result of the
construction and operation of the proposed project. We have already
identified several issues that we think deserve attention based on a
preliminary review of the project site and the facility information
provided by CEGT. This preliminary list of issues may be changed based
on your comments and our analysis.
     Potential effects on prime farmland soils and soils with a
high potential for compaction.
     Potential impacts to perennial and intermittent streams
and waterbodies.
     Potential effects on waterbodies designated under Federal
and/or State programs, including Saline Bayou and Black Lake Bayou.
     Evaluation of temporary and permanent impacts on wetlands
and development of appropriate mitigation.
     Potential impacts to fish and wildlife habitat, including
waterbird nesting areas along major river crossings.
     Potential effect on federally and State-listed species,
including the red-cockaded woodpecker, bald eagle, pallid sturgeon,
least tern, pine snake, and Louisiana black bear.
     Potential impacts to existing land uses, including
agricultural and managed forested lands.
     Potential visual effects of the aboveground facilities on
surrounding areas.
     Potential impacts and potential benefits of construction
workforce on local housing, infrastructure, public services, and
economy.
     Potential impacts to local air and noise quality
associated with construction and operation.
     Assessment of potential cultural resources along the
pipeline route.
     Native American and tribal concerns.
     Public safety and potential hazards associated with the
transport of natural gas.
     Alternative alignments for the pipeline route and
alternative sites for the compressor stations.
     Assessment of the effect of the proposed project when
combined with other past, present, or reasonably foreseeable future
actions in the project area.

Public Participation

    You can make a difference by providing us with your specific
comments or concerns about the proposed project. By becoming a
commentor, your concerns will be addressed in the EIS and considered by
the Commission. Your comments should focus on the potential
environmental effects, reasonable alternatives (including alternative
facility sites and pipeline routes), and measures to avoid or lessen
environmental impact. The more specific your comments, the more useful
they will be. To ensure that your comments are timely and properly
recorded, please carefully follow these instructions:
     Send an original and two copies of your letter to: Magalie
R. Salas, Secretary, Federal Energy Regulatory Commission, 888 First
St., NE., Room 1A, Washington, DC 20426.
     Label one copy of your comments for the attention of Gas
Branch 3, DG2E.
     Reference Docket No. PF06-1-000 on the original and both
copies.
     Mail your comments so that they will be received in
Washington, DC on or before February 10, 2006.
    Please note that we are continuing to experience delays in mail
deliveries from the U.S. Postal Service. As a result, we will include
all comments that we receive within a reasonable time frame in our
environmental analysis of this project. However, the Commission
strongly encourages electronic filing of any comments in response to
this Notice of Intent. For information on electronically filing
comments, please see the instructions on the Commission's Web site at
http://www.ferc.gov under the ``e-Filing'' link and the link to the

User's Guide, as well as information in 18 CFR 385.2001(a)(1)(iii).
Before you can submit comments you will need to create a free account,
which can be created on-line.
    The public scoping meetings (dates, times, and locations are listed
above) are designed to provide another opportunity to offer comments on
the proposed project. Interested groups and individuals are encouraged
to attend the meetings and to present comments on the environmental
issues they believe should be addressed in the EIS. A transcript of
each meeting will be generated so that your comments will be accurately
recorded.
    Once CEGT formally files its application with the Commission, you
may want to become an official party to the proceeding known as an
``intervenor.'' Intervenors play a more formal role in the process and
are able to file briefs, appear at hearings, and be heard by the courts
if they choose to appeal the Commission's final ruling. An intervenor
formally participates in a Commission proceeding by filing a request to
intervene. Instructions for becoming an intervenor are included in the
User's Guide under the ``e-filing'' link on the Commission's Web site.
Please note that you may not request

intervenor status at this time. You must wait until a formal
application is filed with the Commission.

Environmental Mailing List

    An effort is being made to send this notice to all individuals,
organizations, and government entities interested in and/or potentially
affected by the proposed project. This includes all landowners who are
potential right-of-way grantors, whose property may be used temporarily
for project purposes, or who own homes within distances defined in the
Commission's regulations of certain aboveground facilities.
    If you received this notice, you are on the environmental mailing
list for this project. If you do not want to send comments at this
time, but still want to remain on our mailing list, please return the
Information Request (Appendix 3). If you do not return the Information
Request, you will be removed from the Commission's environmental
mailing list.

Availability of Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at 1-866-208-FERC (3372) or on
the FERC Internet Web site (http://www.ferc.gov) using the ``eLibrary

link.'' Click on the eLibrary link, select ``General Search'' and enter
the project docket number excluding the last three digits (i.e., PF06-
1) in the ``Docket Number'' field. Be sure you have selected an
appropriate date range. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or TTY, contact<PHONE_NUMBER>. The eLibrary link on the FERC Internet
Web site also provides access to the texts of formal documents issued
by the Commission, such as orders, notices, and rulemakings.
    In addition, the FERC now offers a free service called
eSubscription that allows you to keep track of all formal issuances and
submittals in specific dockets. This can reduce the amount of time you
spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. To register for this service, go to http://www.ferc.gov/esubscribenow.htm
.

    Public meetings or site visits will be posted on the Commission's
calendar located at http://www.ferc.gov/EventCalendar/EventsList.aspx

along with other related information.
    Finally, CEGT has established an Internet Web site for this project
at http://www.centerpointenergy.com/carthagetoperryville/. The Web site

includes a description of the project, a map of the proposed pipeline
route, and answers to frequently asked questions. You can also request
additional information or provide comments directly to CEGT at 1-888-
641-8326 or carthagetoperryville@CenterPoint Energy.com.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-286 Filed 1-12-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 122 (Tuesday, June 29, 2021)]
[Rules and Regulations]
[Pages 34130-34131]
[FR Doc No: 2021-13704]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0225; Airspace Docket No. 20-AAL-13]
RIN 2120-AA66

Amendment of Class E Airspace; Anaktuvuk Pass, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action modifies the Class E airspace extending upward
from 700 feet above the surface at Anaktuvuk Pass Airport, Anaktuvuk
Pass, AK. This action updates the airport's geographic coordinates and
removes the Anaktuvuk Pass NDB from the Class E5 text header and
airspace description. The airspace supports instrument flight rules
(IFR) operations at the airport.

DATES: Effective 0901 UTC, October 7, 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 7400.11 and
publication of conforming amendments.

ADDRESSES: FAA Order 7400.11E, 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 Airspace Policy Group, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11E at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Matthew Van Der Wal, Federal Aviation
Administration, Western Service Center, Operations Support Group, 2200
. 216th Street, Des Moines, WA 98198; telephone<PHONE_NUMBER>.

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 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
Class E airspace at Anaktuvuk Pass Airport, Anaktuvuk Pass, AK, to
ensure the safety and management of IFR operations at the airport.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (86 FR 18490; April 9, 2021) for Docket No. FAA-2021-0225 to
modify the Class E airspace at Anaktuvuk Pass Airport, Anaktuvuk Pass,
AK. Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received.
    The NPRM for this action proposed to establish Class E airspace
extending upward from 1,200 feet above the surface at Anaktuvuk Pass
Airport. However, after the publication of the NPRM, the FAA determined
that a previous Final Rule (76 FR 78144; December 16, 2011) for Docket
No. FAA-2011-0867 established Class E airspace extending upward from
1,200 feet above the surface within a 66-mile radius of the airport.
This airspace area was not included in the Class E5 airspace
description published in FAA Order 7400.11E. Since Class E airspace,
extending upward from 1,200 feet above the surface, already exists for
the airport, the FAA is not modifying this airspace area. The airspace
area has been added to the Class E5 airspace legal description.
    Class E5 airspace designations are published in paragraph 6005 of
FAA Order 7400.11E, dated July 21, 2020, and effective September 15,
2020, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11E, Airspace Designations and
Reporting Points, dated July 21, 2020, and effective September 15,
2020. FAA Order 7400.11E is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11E lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to 14 CFR part 71 modifies the Class E airspace,
extending upward from 700 feet above the surface, at Anaktuvuk Pass
Airport, Anaktuvuk Pass, AK. The modification properly sizes the
airspace to contain IFR departures until reaching 1,200 feet above the
surface, and IFR arrivals descending below 1,500 feet above the
surface. The airspace's circular radius is reduced from 6.4 miles to 4
miles and three areas are added to the 4-mile radius. Two areas
northeast of the airport and one area southwest of the airport.
    This action also removes the Anaktuvuk Pass NDB from the Class E5
text header and airspace description. The Navigational Aid (NAVAID) is
not needed to describe the airspace and removal of the NAVAID
simplifies the airspace's description.
    This action also updates the airport's geographical coordinates to
``lat. 68[deg]08'01'' N, long. 151[deg]44'36'' W.''
    FAA Order 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, is
non-controversial, and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
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, would 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 qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant the preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of 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 14 CFR part 71 continues 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 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AAL AK E5 Anaktuvuk Pass, AK [Amended]

Anaktuvuk Pass Airport, AK
    (Lat. 68[deg]08'01'' N, long. 151[deg]44'36'' W)

    That airspace extending upward from 700 feet above the surface
within a 4-mile radius of the airport, and within 1.0 mile west and
1.2 miles east of the 022[deg] bearing from the airport, extending
from the 4-mile radius to 23.7 miles north of the airport, and
within 2.4 miles west and 1.8 miles east of the 038[deg] bearing
from the airport, extending from the 4-mile radius to 13 miles
northeast of the airport, and within 1 mile each side of the
233[deg] bearing from the airport, extending from the 4-mile radius
to 4.5 miles southwest of the airport; and that airspace extending
upward from 1,200 feet above the surface within a 66-mile radius of
the airport.

    Issued in Des Moines, Washington, on June 22, 2021.
B.G. Chew,
Acting Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2021-13704 Filed 6-28-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 51 (Friday, March 17, 2017)]
[Rules and Regulations]
[Pages 14119-14122]
[FR Doc No: 2017-05334]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2016-9401; Special Conditions No. 25-651-SC]

Special Conditions: Avionics Design Services Ltd., Textron Model
550/S550/560/560XL Airplanes; Rechargeable Lithium Batteries and
Battery Systems

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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

SUMMARY: These special conditions are issued for the Textron Model 550/
S550/560/560XL airplanes. These airplanes, as modified by Avionics
Design Services Ltd., will have a novel or unusual design feature when
compared to the state of technology envisioned in the airworthiness
standards for transport-category airplanes. This design feature is
rechargeable lithium batteries and battery systems installed in the
airplanes. The applicable airworthiness regulations do not contain
adequate or appropriate safety standards for this design feature. These
special conditions contain the additional safety standards that the
Administrator considers necessary to establish a level of safety
equivalent to that established by the existing airworthiness standards.

DATES: This action is effective on Textron on March 17, 2017. We must
receive your comments by May 1, 2017.

ADDRESSES: Send comments identified by docket number FAA-2016-9401
using any of the following methods:
    [squ] Federal eRegulations Portal: Go to http://www.regulations.gov/and follow

the online instructions for sending your comments electronically.
    [squ] Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC, 20590-0001.
    [squ] Hand Delivery or Courier: Take comments to Docket Operations
in Room W12-140 of the West Building Ground Floor at 1200 New Jersey
Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
    [squ] Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov/, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA docket, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov/.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov/ at any time. Follow the online instructions
for accessing the docket or go to Docket Operations in Room W12-140 of
the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Nazih Khaouly, FAA, Airplane and
Flightcrew Interface Branch, ANM-111, Transport Airplane Directorate,
Aircraft Certification Service, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    The substance of these special conditions has been subject to the
notice and comment period in several prior instances and has been
derived without substantive change from those previously issued. It is
unlikely that prior public comment would result in a significant change
from the substance contained herein. Therefore, because a delay would
significantly affect the certification of the airplane, the FAA has
determined that prior public notice and comment are unnecessary and
impracticable, and good cause exists for making these special
conditions effective upon publication in the Federal Register.

Comments Invited

    We invite interested people to take part in this rulemaking by
sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    We will consider all comments we receive by the closing date for
comments. We may change these special conditions based on the comments
we receive.

Background

    On July 9, 2015, Avionics Design Services Ltd. applied for a
supplemental type certificate for rechargeable lithium batteries and
battery systems installed in Textron Model 550/S550/560/560XL
airplanes. These airplanes are twin-engine, transport-category business
jets with a maximum capacity of 8 (Models 550 and 560) or 9 (Models
S550 and 560XL) passengers, and maximum takeoff weights of 15,100 lbs.
(Models 550 and S550), 16,300 lbs. (Model 560), and 20,200 lbs. (Model
560XL).

Type Certification Basis

    Under the provisions of Title 14, Code of Federal Regulations (14
CFR) 21.101, Avionics Design Services Ltd. must show that the Textron
Model 550/S550/560/560XL airplanes, as changed, continue to meet the
applicable provisions of the regulations listed in Type Certificate No.
A22CE, or the applicable regulations in effect on the date of
application for the change, except for earlier amendments as agreed
upon by the FAA.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the Textron Model 550/S550/560/560XL
airplanes, as modified by Avionics Design Services Ltd., because of a
novel or unusual design feature, special conditions are prescribed
under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the applicant apply for a supplemental type
certificate to modify any other model included on the same type
certificate to incorporate the same novel or unusual design feature,
these special conditions would also apply to the other model under
Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the Model 550/S550/560/560XL airplanes, as modified by
Avionics Design Services Ltd., must comply with the fuel-vent and
exhaust-emission requirements of 14 CFR part 34, and the noise-
certification requirements of 14 CFR part 36.
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type
certification basis under Sec.  21.101.

Novel or Unusual Design Features

    The Textron Model 550/S550/560/560XL airplanes, as modified by
Avionics Design Services Ltd., will incorporate the following novel or
unusual design feature:
    Installed rechargeable lithium batteries and battery systems.
    Rechargeable lithium batteries are a novel or unusual design
feature in transport-category airplanes. This type of battery has
certain failure, operational, and maintenance characteristics that
differ significantly from those of the nickel-cadmium and lead-acid
rechargeable batteries currently approved for installation on
transport-category airplanes.

Discussion

    Rechargeable lithium batteries are novel and unusual with respect
to the state of technology considered when these requirements were
codified. These batteries introduce higher energy levels into airplane
systems through new chemical compositions in various battery-cell sizes
and construction. Interconnection of these cells in battery packs
introduces failure modes that require unique design considerations,
such as provisions for thermal management.
    Recent events involving rechargeable and non-rechargeable lithium
batteries prompted the FAA to initiate a broad evaluation of these
energy-storage technologies. In January 2013, two independent events
involving rechargeable lithium-ion batteries demonstrated unanticipated
failure modes. These events are described in a National Transportation
Safety Board letter to the FAA, dated May 22, 2014, which is available
at: http://www.ntsb.gov/doclib/recletters/2014/A-14-032-036.pdf.
    On July 12, 2013, an event involving a non-rechargeable lithium
battery in an emergency-locator transmitter installation demonstrated
unanticipated failure modes. This event is described in Air Accident
Investigations Branch Bulletin S5/2013, available at: http://www.aaib.gov.uk/cms_resources.cfm?file=/S5-2013%20ET-AOP.pdf.

    Some other known uses of rechargeable and non-rechargeable lithium
batteries on airplanes include:
    [squ] Flight deck and avionics systems such as displays, global-
positioning systems, cockpit voice recorders, flight-data recorders,
underwater-locator beacons, navigation computers, integrated avionics
computers, satellite network/communication systems, communication-
management units, and remote-monitor electronic line replaceable units
(LRU);
    [squ] Cabin safety, entertainment and communications equipment
including life rafts, escape slides, seatbelt air bags, cabin-
management systems, Ethernet switches, routers and media servers,
wireless systems, internet and in-flight entertainment systems,
satellite televisions, and remote controls and handsets; and,
    [squ] Systems in cargo areas including door controls, sensors,
video surveillance equipment and security systems.
    Some known potential hazards and failure modes associated with
rechargeable lithium batteries are:
    [squ] Internal failures. In general, these batteries are
significantly more susceptible to internal failures that can result in
self-sustaining increases in temperature and pressure (i.e., thermal
runaway) than their nickel-cadmium or lead-acid counterparts. The
metallic lithium can ignite, resulting in a self-sustaining fire or
explosion.
    [squ] Fast or imbalanced discharging. Fast discharging, or an
imbalanced discharge of one cell of a multi-cell battery, may create an
overheating condition that results in an uncontrollable venting
condition which, in turn, leads to a thermal event or an explosion.
    [squ] Flammability. Unlike nickel-cadmium and lead-acid batteries,
these batteries use higher energy and current in an electrochemical
system that can be configured to maximize energy storage of lithium,
and use liquid electrolytes that can be extremely flammable. The
electrolyte, as well as the electrodes, can serve as a source of fuel
for an external fire if the battery casing is breached.
    These special conditions contain the additional safety standards
that the Administrator considers necessary to establish a level of
safety equivalent to that established by the existing airworthiness
standards.

Applicability

    As discussed above, these special conditions are applicable to the
Textron Model 550/S550/560/560XL airplanes as modified by Avionics
Design Services Ltd. Should Avionics Design Services Ltd. apply at a
later date for a supplemental type certificate to modify any other
model included on Type Certificate No. A22CE to incorporate the same
novel or unusual design feature, these special conditions would apply
to that model as well.

Conclusion

    This action affects only a certain novel or unusual design feature
on one model series of airplanes. It is not a rule of general
applicability and affects only the applicant who applied to the FAA for
approval of these features on the airplane.
    The substance of these special conditions has been subjected to the
notice and comment period in several prior instances and has been
derived without substantive change from those previously issued. It is
unlikely that prior public comment would result in a significant change
from the substance contained herein. Therefore, because a delay would
significantly affect the certification of the airplane, the FAA has
determined that prior public notice and comment are unnecessary and
impracticable, and good cause exists for adopting these special
conditions upon publication in the Federal Register. The FAA is
requesting comments to allow interested persons to submit views that
may not have been submitted in response to the prior opportunities for
comment described above.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Textron Model 550/S550/560/560XL
airplanes modified by Avionics Design Services Ltd.
    Each rechargeable lithium battery installation must:
    1. Be designed so that safe cell temperatures and pressures are
maintained under all foreseeable operating conditions to preclude fire
and explosion.
    2. Be designed to preclude the occurrence of self-sustaining,
uncontrolled increases in temperature or pressure.
    3. Not emit explosive or toxic gases in normal operation, or as a
result of its failure, that may accumulate in hazardous quantities
within the airplane.
    4. Meet the requirements of Title 14, Code of Federal Regulations
25.863.
    5. Not damage surrounding structure or adjacent systems, equipment,
or electrical wiring from corrosive fluids or gases that may escape.
    6. Have provisions to prevent any hazardous effect on airplane
structure or systems caused by the maximum amount of heat the
installation can generate due to any failure of it or its individual
cells.
    7. Be capable of automatically controlling the charge rate of each
cell to prevent cell imbalance, back charging, overcharging,
overheating, and uncontrollable temperature and pressure.
    8. Have a means to be automatically disconnected from its charging
source in the event of an over-temperature condition, cell failure, or
battery failure.
    9. Have a failure sensing and warning system to alert the
flightcrew if the installation's failure affects safe operation of the
airplane.
    10. If its function is required for safe operation of the airplane,
the installment must have a monitoring and warning feature that alerts
the flightcrew when its charge state falls below acceptable levels.

    Note 1: A battery system consists of the battery, battery
charger, and any protective, monitoring, and alerting circuitry or
hardware inside or outside of the battery. It also includes vents
(where necessary) and packaging. For the purpose of these special
conditions, a battery and battery system are referred to as a
battery.

    Note 2: These special conditions apply to all rechargeable
lithium battery installations in lieu of Title 14, Code of Federal
Regulations 25.1353(c)(1) through (c)(4) at Amendment 25-42. Section
25.1353(c)(1) through (c)(4) at Amendment 25-42 remains in effect
for other battery installations.

    Note 3: Section 25.863 is applicable to areas of the airplane
that could be exposed to flammable fluid leakage from airplane
systems. Rechargeable lithium batteries contain electrolyte that is
a flammable fluid. The FAA includes special condition 4 to make it
clear to applicants that the flammable-fluid fire-protection
requirements of Sec.  25.863 apply to rechargeable lithium battery
installations.

    Note 4: Special conditions 7 and 8 require rechargeable lithium
batteries to have ``automatic'' means, for charge rate and
disconnect, due to the fast-acting nature of lithium battery
chemical reactions. Manual intervention would not be timely or
effective in mitigating the hazards associated with these batteries.

    Issued in Renton, Washington, on February 23, 2017.
Michael Kaszycki,
Assistant Manager, Transport Airplane Directorate, Aircraft
Certification Service.
[FR Doc. 2017-05334 Filed 3-16-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 102 (Friday, May 28, 2021)]
[Notices]
[Pages 28832-28833]
[FR Doc No: 2021-11383]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2020-0182; FRL-10024-13-ORD]

Availability of the IRIS Assessment Plan for Inhalation Exposure
to Vanadium and Compounds

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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

SUMMARY: The Environmental Protection Agency (EPA) is announcing a 30-
day public comment period associated with release of the IRIS
Assessment Plan for Inhalation Exposure to Vanadium and Compounds. This
document communicates information on the scoping needs identified by
EPA program and regional offices and the IRIS Program's initial problem
formulation activities. EPA is releasing this IRIS Assessment Plan for
a 30-day public comment period in advance of a public science webinar
planned for July 2021. EPA will announce the virtual public meeting
date and registration details in June 2021 on the EPA IRIS website.

DATES: The 30-day public comment period begins May 28, 2021 and ends
June 28, 2021. Comments must be received on or before June 28, 2021.

ADDRESSES: The IRIS Assessment Plan for Inhalation Exposure to Vanadium
and Compounds will be available via the internet on the IRIS website at
https://www.epa.gov/iris/iris-recent-additions and in the public docket
at http://www.regulations.gov, Docket ID No. EPA-HQ-ORD-2020-0182.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the ORD Docket at the EPA Headquarters Docket Center;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or email:
<EMAIL_ADDRESS>    For technical information on the IRIS Assessment Plan for
Inhalation Exposure to Vanadium and Compounds, contact Mr. Dahnish
Shams, CPHEA; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Information About IRIS Assessment Plans

    EPA's IRIS Program is a human health assessment program that
evaluates quantitative and qualitative information on the health
effects that may result from exposure to chemicals found in the
environment. Through the IRIS Program, EPA provides high quality
science-based human health assessments to support the Agency's
regulatory activities and decisions to protect public health. As part
of scoping and initial problem formulation activities prior to the
development of an assessment, the IRIS Program carries out a broad,
preliminary literature survey to assist in identifying health effects
that have been studied in relation to the chemical or substance of
interest, as well as science issues that may need to be considered when
evaluating toxicity. This information, in conjunction with scoping
needs identified by EPA program and regional offices, is used to inform
the development of an IRIS Assessment Plan (IAP).
    The IAP communicates the plan for developing each individual
chemical assessment to the public and includes summary information on
the IRIS Program's scoping and initial problem formulation activities,
objectives and specific aims for the assessment, and a PECO
(Populations, Exposures, Comparators, and Outcomes) for the systematic
review. The PECO provides the framework for developing detailed
literature search strategies and inclusion/exclusion criteria,
particularly with respect to evidence stream (e.g., human, animal,
mechanistic), exposure measures, and outcome measures. The IAP serves
to inform the subsequent development of chemical-specific systematic
review protocols, which will be made available for public review.

II. Public Webinar Information

    To allow for public input, EPA is convening a public webinar to
discuss the IRIS Assessment Plan for Inhalation Exposure to Vanadium
and Compounds in July 2021. EPA will announce the virtual public
meeting date and registration details in June 2021 on the EPA IRIS
website (https://www.epa.gov/iris). Registration information will be
provided through the IRIS website (https://www.epa.gov/iris) and via
EPA's IRIS listserv. To sign-up for the IRIS listserv, visit IRIS
website at https://www.epa.gov/iris/forms/staying-connected-integrated-risk-information-system#connect.

III. How To Submit Technical Comments to the Docket at https://www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2020-
0182 for IRIS Assessment Plan for Inhalation Exposure to Vanadium and
Compounds, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>. Due to COVID-19, there may be a delay
in processing comments submitted by fax.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center (ORD Docket), Mail Code: 28221T, 1200 Pennsylvania Avenue NW,
Washington, DC 20460. The phone number is<PHONE_NUMBER>. Due to COVID-
19, there may be a delay in processing comments submitted by mail.
    Note: The EPA Docket Center and Reading Room is currently closed to
public visitors to reduce the risk of transmitting COVID-19. Docket
Center staff will continue to provide remote customer service via
email, phone, and webform. The public can submit comments via
www.Regulations.gov or email. No hand deliveries are currently being
accepted.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2020-0182. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at
www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information for which disclosure is
restricted by statute. Do not submit information through
www.regulations.gov or email that you consider to be CBI or otherwise
protected. The www.regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA

Docket Center homepage at www.epa.gov/epahome/dockets.htm.
    Docket: Documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the ORD Docket in the EPA
Headquarters Docket Center.

Wayne Cascio,
Director, Center for Public Health & Environmental Assessment.
[FR Doc. 2021-11383 Filed 5-27-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 122 (Monday, June 25, 2012)]
[Notices]
[Page 37953]
[FR Doc No: 2012-15278]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Opportunity for Public Comment on Surplus Property
Release at Laurinburg-Maxton Airport, Maxton, NC

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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

SUMMARY: Under the provisions of Title 49, U.S.C. Section 47153(c),
notice is being given that the FAA is considering a request from the
Laurinburg-Maxton Airport Commission to waive the requirement that
approximately 10 acres of airport property, located at the Laurinburg-
Maxton Airport, be used for aeronautical purposes.

DATES: Comments must be received on or before July 25, 2012.

ADDRESSES: Comments on this notice may be mailed or delivered in
triplicate to the FAA at the following address: Atlanta Airports
District Office, Attn: Rusty Nealis, Program Manager, 1701 Columbia
Ave., Suite 2-260, Atlanta, GA 30337-2747.
    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to JoAnn Gentry, Executive Director, Laurinburg-
Maxton Airport Commission at the following address: Laurinburg-Maxton
Airport Commission, 16701 Airport Road, Maxton, NC 28364.

FOR FURTHER INFORMATION CONTACT: Rusty Nealis, Program Manager, Atlanta
Airports District Office, 1701 Columbia Ave., Campus Building, Suite 2-
260, Atlanta, GA 30337-2747,<PHONE_NUMBER>. The application may be
reviewed in person at this same location.

SUPPLEMENTARY INFORMATION: The FAA is reviewing a request by the
Laurinburg-Maxton Airport Commission to release approximately 10 acres
of airport property at the Laurinburg-Maxton Airport. The property
consists of one parcel located at the northeast intersection of S.R.
1434 (Airport Road) and S.R. 1472 (Jump Road). This property is
currently shown on the approved Airport Layout Plan as non-aeronautical
use land and the proposed use of this property is compatible with
airport operations. The City will sell the property for industrial use
with proceeds of the sale providing funding for future airport
development.
    Any person may inspect the request in person at the FAA office
listed above under FOR FURTHER INFORMATION CONTACT. In addition, any
person may, upon request, inspect the request, notice and other
documents germane to the request in person at the Laurinburg-Maxton
Airport.

    Issued in Atlanta, Georgia, on June 12, 2012.
Scott L. Seritt,
Manager, Atlanta Airports District Office, Southern Region.
[FR Doc. 2012-15278 Filed 6-22-12; 8:45 am]
BILLING CODE 4910-13-M


[Federal Register Volume 84, Number 173 (Friday, September 6, 2019)]
[Notices]
[Pages 46956-46958]
[FR Doc No: 2019-19290]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0223]

Humanitarian Device Exemption Program; 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 a final guidance entitled ``Humanitarian Device
Exemption Program.'' This guidance concerns the humanitarian device
exemption (HDE) program as a whole and, among other topics, it explains
the criteria FDA considers to determine if ``probable benefit'' has
been demonstrated as part of the Agency's

decision-making process regarding marketing authorization for a
humanitarian use device (HUD). The guidance also reflects recent
amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) that
affect the HDE program and answers common questions that we receive
about the program.

DATES: The announcement of the guidance is published in the Federal
Register on September 6, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-D-0223 for ``Humanitarian Device Exemption Program.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    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 guidance document entitled
``Humanitarian Device Exemption Program'' to the Office of Policy,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002; or to the Office of Communication, Outreach and
Development, Center for Biologics Evaluation and Research (CBER), 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: Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
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,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA developed this guidance to clarify to industry and FDA staff
the current review practices for the HDE program. This guidance answers
common questions about the HDE program and responds to a requirement in
the 21st Century Cures Act (Cures Act) (Pub. L. 114-255) to define the
criteria for establishing ``probable benefit'' as that term is used in
section 520(m)(2)(C) of the FD&C Act (21 U.S.C. 360j(m)(2)(C)).
    This guidance reflects recent amendments to the FD&C Act that
affect the HDE program. Specifically, section 3052 of the Cures Act
modified the eligibility for an HDE by increasing the threshold number
of patients affected by the disease or condition that a HUD is designed
to treat or diagnose to ``not more than 8,000 individuals in the United
States.'' Further, section 3056 of the Cures Act removed the
requirement that institutional review committees, i.e., institutional
review boards (IRBs), that supervise the clinical testing of HUDs or
approve the use of HUDs in clinical care, be local. Additionally, the
FDA Reauthorization Act of 2017 (Pub. L. 115-52) amended section 520(m)
of the FD&C Act to provide that the use of a device under an HDE at a
facility to treat or diagnose patients may be approved by an IRB or an
appropriate local committee. Previously, section 520(m)(4) of the FD&C
Act only allowed an IRB to perform this function.
    FDA considered comments received on the draft guidance that
appeared in the Federal Register of June 13, 2018 (83 FR 27614). FDA
revised the guidance as appropriate in response to

the comments. This guidance supersedes ``Guidance for HDE Holders,
Institutional Review Boards (IRBs), Clinical Investigators, and Food
and Drug Administration Staff; Humanitarian Device Exemption (HDE)
Regulation: Questions and Answers,'' issued July 8, 2010 (available at:
https://www.fda.gov/media/74307/download).

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on the Humanitarian Device Exemption Program.
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. This
guidance is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to
download an electronic copy of ``Humanitarian Device Exemption
Program'' may send an email request to<EMAIL_ADDRESS>to
receive an electronic copy of the document. Please use the document
number 17040 and complete title of the guidance in the request.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. 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
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:

------------------------------------------------------------------------
 21 CFR part, guidance, or FD&C                            OMB  control
          Act section                     Topic                 No.
------------------------------------------------------------------------
807, 812, 814..................  Acceptance of Data from       0910-0741
                                  Clinical
                                  Investigations for
                                  Medical Devices.
814............................  Pediatric Uses of             0910-0748
                                  Devices.
814, subparts A through E......  Premarket Approval.....       0910-0231
814, subpart H.................  Humanitarian Device           0910-0332
                                  Exemption.
812............................  Investigational Device        0910-0078
                                  Exemption.
``De Novo Classification         De Novo classification        0910-0844
 Process (Evaluation of           process.
 Automatic Class III
 Designation)''.
803............................  Medical Devices;              0910-0437
                                  Medical Device
                                  Reporting;
                                  Manufacturer
                                  Reporting, Importer
                                  Reporting, User
                                  Facility Reporting,
                                  Distributor Reporting.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
520(m) of the FD&C Act.........  Humanitarian Device           0910-0661
                                  Exemption Applications
                                  and Annual
                                  Distribution Number
                                  Reporting Requirements.
50, 56.........................  Protection of Human           0910-0755
                                  Subjects: Informed
                                  Consent; Institutional
                                  Review Boards.
56.............................  Institutional Review          0910-0130
                                  Boards.
10.............................  Administrative                0910-0191
                                  Practices and
                                  Procedures.
54.............................  Financial Disclosure by       0910-0396
                                  Clinical Investigators.
------------------------------------------------------------------------

    Dated: September 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19290 Filed 9-5-19; 8:45 am]
 BILLING CODE 4164-01-P