[Federal Register Volume 81, Number 149 (Wednesday, August 3, 2016)]
[Notices]
[Pages 51196-51197]
[FR Doc No: 2016-18361]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CD16-16-000]

Metropolitan District; Notice of Preliminary Determination of a
Qualifying Conduit Hydropower Facility and Soliciting Comments and
Motions To Intervene

    On July 22, 2016, the Metropolitan District filed a notice of
intent to construct a qualifying conduit hydropower facility, pursuant
to section 30 of the Federal Power Act (FPA), as amended by section 4
of the Hydropower Regulatory Efficiency Act of 2013 (HREA). The
proposed Barkhamsted Transmission Hydro No. 1 Project would have an
installed capacity of 250 kilowatts (kW) and would be located at a 48-
inch-diameter gravity pressure raw water supply pipe. The project would
be located near the City of New Hartford in Lichfield County,
Connecticut.
    Applicant Contact: Scott Jellison, Metropolitan District, 555 Main
Street, Hartford, CT 06142, Phone No.<PHONE_NUMBER>, Ext 3522.
    FERC Contact: Robert Bell, Phone No.<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Qualifying Conduit Hydropower Facility Description: The proposed
project would consist of: (1) A proposed 250-kW turbine replacing the
existing booster pump (which is unused) in the Puddletown booster pump
station and (2) appurtenant facilities. The proposed project would have
an estimated annual generating capacity of 1,475 megawatt-hours.
    A qualifying conduit hydropower facility is one that is determined
or deemed to meet all of the criteria shown in the table below.

      Table 1--Criteria for Qualifying Conduit Hydropower Facility
------------------------------------------------------------------------
      Statutory provision              Description       Satisfies (Y/N)
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FPA 30(a)(3)(A), as amended by   The conduit is a                     Y
 HREA.                            tunnel, canal,
                                  pipeline, aqueduct,
                                  flume, ditch, or
                                  similar manmade water
                                  conveyance that is
                                  operated for the
                                  distribution of water
                                  for agricultural,
                                  municipal, or
                                  industrial
                                  consumption and not
                                  primarily for the
                                  generation of
                                  electricity.
FPA 30(a)(3)(C)(i), as amended   The facility is                      Y
 by HREA.                         constructed,
                                  operated, or
                                  maintained for the
                                  generation of
                                  electric power and
                                  uses for such
                                  generation only the
                                  hydroelectric
                                  potential of a non-
                                  federally owned
                                  conduit.
FPA 30(a)(3)(C)(ii), as amended  The facility has an                  Y
 by HREA.                         installed capacity
                                  that does not exceed
                                  5 megawatts.
FPA 30(a)(3)(C)(iii), as         On or before August 9,               Y
 amended by HREA.                 2013, the facility is
                                  not licensed, or
                                  exempted from the
                                  licensing
                                  requirements of Part
                                  I of the FPA.
------------------------------------------------------------------------

    Preliminary Determination: Based upon the above criteria,
Commission staff has preliminarily determined that the proposal
satisfies the requirements for a qualifying conduit hydropower facility
under 16 U.S.C. 823a, and is exempted from the licensing requirements
of the FPA.

    Comments and Motions to Intervene: The deadline for filing comments
contesting whether the facility meets the qualifying criteria is 45
days from the issuance date of this notice.
    The deadline for filing motions to intervene is 30 days from the
issuance date of this notice.
    Anyone may submit comments or a motion to intervene in accordance
with the requirements of Rules of Practice and Procedure, 18 CFR
385.210 and 385.214. Any motions to intervene must be received on or
before the specified deadline date for the particular proceeding.
    Filing and Service of Responsive Documents: All filings must (1)
bear in all capital letters the ``COMMENTS CONTESTING QUALIFICATION FOR
A CONDUIT HYDROPOWER FACILITY'' or ``MOTION TO INTERVENE,'' as
applicable; (2) state in the heading the name of the applicant and the
project number of the application to which the filing responds; (3)
state the name, address, and telephone number of the person filing; and
(4) otherwise comply with the requirements of sections 385.2001 through
385.2005 of the Commission's regulations.\1\ All comments contesting
Commission staff's preliminary determination that the facility meets
the qualifying criteria must set forth their evidentiary basis.
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    \1\ 18 CFR 385.2001-2005 (2015).
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    The Commission strongly encourages electronic filing. Please file
motions to intervene and comments using the Commission's eFiling system
at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. A copy of all other filings in
reference to this application must be accompanied by proof of service
on all persons listed in the service list prepared by the Commission in
this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
    Locations of Notice of Intent: Copies of the notice of intent can
be obtained directly from the applicant or such copies can be viewed
and reproduced at the Commission in its Public Reference Room, Room 2A,
888 First Street NE., Washington, DC 20426. The filing may also be
viewed on the web at http://www.ferc.gov/docs-filing/elibrary.asp using
the ``eLibrary'' link. Enter the docket number (e.g., CD16-16-000) in
the docket number field to access the document. For assistance, call
toll-free 1-866-208-3676 or email<EMAIL_ADDRESS>For TTY,
call<PHONE_NUMBER>.

    Dated: July 28, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-18361 Filed 8-2-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 33 (Friday, February 17, 2012)]
[Notices]
[Pages 9726-9727]
[FR Doc No: 2012-3766]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2012-0019; Notice 1]

Utilimaster Corporation, Receipt of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Receipt of Petition.

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SUMMARY: Utilimaster Corporation (Utilimaster) \1\ has determined that
certain model year 2009-2011 Utilimaster walk-in van-type trucks
manufactured between September 1, 2009, and December 22, 2011, do not
fully comply with paragraph S4.2.1 of Federal Motor Vehicle Safety
Standard (FMVSS) No. 206, Door Locks and Door Retention Components.
Utilimaster has filed an appropriate report dated December 30, 2011,
pursuant to 49 CFR part 573, Defect and Noncompliance Responsibility
and Reports.
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    \1\ Utilimaster Corporation, a wholly owned subsidiary of
Spartan Motors, Inc., is manufacturer of motor vehicles and is
registered under the laws of Delaware.
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    Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule
at 49 CFR part 556), Spartan Motors, Inc.,\2\ on behalf of Utilimaster
has submitted a petition for an exemption from the notification and
remedy requirements of 49 U.S.C. Chapter 301 on the basis that this
noncompliance is inconsequential to motor vehicle safety.
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    \2\ Spartan Motors, Inc., is a manufacturer of motor vehicles
and is registered under the laws of the state of Michigan.
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    This notice of receipt of Utilimaster's petition is published under
49 U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.
    Affected are approximately 9,861 model year 2009-2011 Utilimaster
walk-in van-type trucks manufactured between September 1, 2009, and
December 22, 2011.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, these provisions
only apply to the subject 9,861 \3\ model year 2009-2011 trucks that
Utilimaster no longer controlled at the time it determined that the
noncompliance existed.
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    \3\ Utilimaster's petition, which was filed under 49 CFR part
556, requests an agency decision to exempt Utilimaster as a vehicle
manufacturer from the notification and recall responsibilities of 49
CFR part 573 for the 9,861 affected vehicles. However, a decision on
this petition cannot relieve vehicle distributors and dealers of the
prohibitions on the sale, offer for sale, introduction or delivery
for introduction into interstate commerce of the noncompliant
vehicles under their control after Utilimaster notified them that
the subject noncompliance existed.
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    Utilimaster explains that the noncompliance is that while the
sliding doors on the vehicles are equipped with a door latch system
with a fully latched position, no door closure warning system, as
required by paragraph S4.2.1 of FMVSS No. 206, is installed.
    Paragraph S4.2.1 of FMVSS No. 206 requires in pertinent part:

    S4.2 Sliding Side Doors.
    S4.2.1 Latch System. Each sliding door system shall be equipped
with either:
    (a) At least one primary door latch system, or
    (b) A door latch system with a fully latched position and a door
closure warning system. The door closure warning system shall be
located where it can be clearly seen by the driver. Upon
certification a manufacturer may not thereafter alter the
designation of a primary latch. Each manufacturer shall, upon
request from the National Highway Traffic Safety Administration,
provide information regarding such designation * * *

Summary of Utilimaster's Analysis and Arguments

    The sliding door latch requirements contained in paragraph S4.2.1
of FMVSS No. 206 were adopted in February 2007 as part of a broader
upgrade to the Agency's existing door latch and retention requirements.
The standard defines ``Primary Door Latch'' as ``a latch equipped with
both a fully latched position and a secondary latched position and is
designated as a `primary door latch' by the manufacturer.'' It defines
``Door Closure Warning System'' as ``a system that will activate a
visual signal when a door latch system is not in its fully latched
position and the vehicle ignition is activated.'' The effective date of
these requirements was September 1, 2009. (The load test requirements
of paragraph S4.2.2 of FMVSS No. 206 became effective September 1,
2010; the subject vehicles do comply with the load requirements.)
    As set forth in Utilimaster's noncompliance report, Utilimaster
determined that the new latch requirements applied to these vehicles,
but were not designed into vehicles built after the effective date.
(This omission was the result of Utilmaster's previous
misinterpretation as to the applicability of the FMVSS No. 206
amendments to these particular vehicles.)
    Specifically, the sliding doors on the subject vehicles are
equipped with a door latch that does not meet the above-referenced
definition of a ``primary door latch,'' because these vehicles lack a
secondary latched position. Thus, these vehicles do not meet the
paragraph S4.2.1(a) compliance option. Moreover, these vehicles are not
equipped with a ``door closure warning system'' and, therefore, they do
not meet the paragraph S4.2.1(b) compliance option. In any event, we
believe that the omission of a door closure warning system on these
vehicles is inconsequential to safety. This is due to the particular
characteristics of the sliding doors on these vehicles, which will
immediately provide adequate visual (and audible) feedback to the
driver to alert him or her in the event a door is unlatched.
    The door has approximately 0.315 inches of engagement into the door
seal. Therefore, should the sliding door not be in the latched
position, it would be readily apparent to the driver before the vehicle
is driven.
    Even if the driver did not notice the gap in the door prior to the
vehicle being driven, these doors would provide immediate visual
feedback to the driver as soon as the vehicle begins to move. The
sliding doors, on these vehicles, are designed to slide longitudinally
on a track when the sliding door handle is activated and a small force
is applied in the same longitudinal direction. As a

consequence, if the sliding door is not fully closed and latched and
the driver is not aware, this fact would become immediately apparent to
the driver when the vehicle is accelerated from rest, as the sliding
door would glide rearward from the force created by the acceleration.
Thus, while these vehicles may not meet the express requirements of
paragraph S4.2.1 or the definition of a ``door closure warning
system,'' Utilimaster believes they do meet the intent of these
requirements. The use of other visual signals, such as a dash-mounted
telltale, might be necessary for vehicles with rear sliding doors, such
as minivans or other passenger vehicles, but the sliding doors on the
subject vehicles are located in the front within plain view of the
driver.
    In adopting the upgraded sliding door standards in 2007, the Agency
stated that it was particularly concerned with children riding in the
rear seats of passenger vans (minivans or ``MPVs'').\4\
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    \4\ 72 FR 5387.
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    As noted above, these vehicles are used exclusively in commercial
applications and are driven exclusively by professional drivers
(primarily without a passenger). The commercial application of walk-in
vans is highly repetitive in nature. To ensure safety and to maximize
productivity, corporations have adopted highly regimented training
programs for drivers in addition to requiring them to carry a
commercial driver's license. The regimented training for the high
majority of commercial applications requires that drivers enter and
exit the vehicle from the curb side of the van. The repetitive use of
the van results in highly repeatable results from one stop to the next.
The likelihood that a driver would move the vehicle with the door left
inadvertently open is very low. Moreover, the likelihood that the
driver would be ejected from the driver's seat, through a curb-side
door, left unintentionally unlatched, is even less probable. These
drivers must adhere to corporate policies as they relate to operating
the vehicle. For example, UPS has strictly enforced requirements for
the drivers to always have the seatbelts fastened when the vehicle is
in motion. Walk-In vans with sliding doors very similar in design to
those on the subject vehicles have been in use for several decades. We
are not aware of a driver or passenger ever having been ejected from,
or fallen through an open sliding cab door, of our vehicles, while the
vehicle was in motion.
    The sliding doors on these vehicles meet all load test and inertial
requirements of FMVSS No. 206, paragraph S4.2. Therefore, this
noncompliance will not increase the risk of occupant ejection under
conditions addressed by such requirements.
    In summation, Utilimaster believes that the described noncompliance
of its vehicles is inconsequential to motor vehicle safety, and that
its petition, to exempt from providing recall notification of
noncompliance as required by 49 U.S.C. 30118 and remedying the recall
noncompliance as required by 49 U.S.C. 30120 should be granted.
    Comments: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited at the beginning of this notice and be
submitted by any of the following methods:
    a. By mail addressed to: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
    b. By hand delivery to U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590. The Docket Section is open on
weekdays from 10 a.m. to 5 p.m. except Federal holidays.
    c. Electronically: By logging onto the Federal Docket Management
System (FDMS) Web site at http://www.regulations.gov/. Follow the
online instructions for submitting comments. Comments may also be faxed
to 1-202-493-2251.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that your comments were received, please
enclose a stamped, self-addressed postcard with the comments. Note that
all comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
    Documents submitted to a docket may be viewed by anyone at the
address and times given above. The documents may also be viewed on the
Internet at http://www.regulations.gov by following the online
instructions for accessing the dockets. DOT's complete Privacy Act
Statement is available for review in the Federal Register published on
April 11, 2000, (65 FR 19477-78).
    The petition, supporting materials, and all comments received
before the close of business on the closing date indicated below will
be filed and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the extent possible. When the petition is granted or
denied, notice of the decision will be published in the Federal
Register pursuant to the authority indicated below.

DATES: Comment Closing Date: March 19, 2012.

    Authority: (49 U.S.C. 30118, 30120: delegations of authority at
CFR 1.50 and 501.8)

    Issued on: February 13, 2012.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2012-3766 Filed 2-16-12; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Page 19035]
[FR Doc No: 2017-08332]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL17-66-000]

California Department of Water Resources State Water Project, the
Cities of Anaheim, Azusa, Banning, Colton, Pasadena, and Riverside,
California, and the California Public Utilities Commission v. Trans Bay
Cable LLC; Notice of Complaint

    Take notice that on April 18, 2017, pursuant to sections 206 and
306 of the Federal Power Act, 16 U.S.C. 824e and 825e, and Rules 206
and 212 of the Federal Energy Regulatory Commission's (Commission)
Rules of Practice and Procedure, 18 CFR 385.206 and 385.212, the
California Department of Water Resources State Water Project, the
Cities of Anaheim, Azusa, Banning, Colton, Pasadena, and Riverside,
California, and the California Public Utilities Commission
(Complainant) filed a formal complaint against Trans Bay Cable LLC
(Respondent) alleging that, Respondent's transmission rates are unjust
and unreasonable, all as more fully explained in the complaint.
    Complainants certify that copies of the complaint were served on
corporate representatives and legal counsel for respondent.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
``eSubscription'' link on the Web site that enables subscribers to
receive email notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on May 8, 2017.

    Dated: April 19, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-08332 Filed 4-24-17; 8:45 am]
BILLING CODE 6717-01-P


SF 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY National Emission Standard for Hazardous Air Pollutants for Steel Pickling 1. Identification of the Information Collection 1( a) Title of the Information Collection National Emission Standard for Hazardous Air Pollutants ( NESHAP) for Steel Pickling 1( b) Short Characterization/ Abstract The National Emission Standards for Hazardous Air Pollutants ( NESHAP) for Steel Pickling, published at 40 CFR Part 63, Subpart CCC, were proposed on September 18, 1997 ( 62 FR 49051), and promulgated on June 22, 1999 ( 64 FR 33202). This rule applies to all facilities that pickle steel using hydrochloric acid or regenerate hydrochloric acid, and are major sources or are part of a facility that is a major source. This regulation does not apply to any pickling line that uses an acid other than hydrochloric acid or an acid solution containing less than 6 percent hydrochloric acid ( HCl) or at a temperature less than 100 º F. This rulemaking establishes limits for hydrochloric acid emissions from continuous and batch pickling lines and acid regeneration units and limits for chlorine emissions from acid regeneration units. Also, operational and equipment standards are established for stationary acid storage vessels.

The monitoring, recordkeeping, and reporting requirements outlined in the rule are similar to those required for other NESHAP regulations. Plants must demonstrate compliance with the emission standards by monitoring their control devices and performing annual emissions testing. Consistent with the NESHAP General Provisions ( 40 CFR Part 63, Subpart A), respondents would submit one time notifications of applicability and a one time report on performance test results for the primary emission control device. Plants also must develop and implement a Startup, Shutdown, and Malfunction Plan ( SSMP) and submit semiannual reports of any event where the procedures in the plan were not followed. Sources are required to submit semiannual reports at all times including for periods of monitoring exceedances and for periods of compliance certifying that no exceedances have occurred during the reporting period. Subpart CCC also requires the owner or operator to submit a written maintenance plan for each emission control device. These notifications, reports, and records are essential in determining compliance, and are required of all sources subject to NESHAP.

Any owner or operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least five years following the date of such measurements, maintenance reports, and records. All reports are sent to the delegated State or local authority. In the event that there is no such delegated authority, the reports are sent directly to the Environmental Protection Agency ( EPA) Regional Office. 2 According to the Federal Register on the proposed rule and on the information of the active ICR, the EPA estimates that 62 of the 80 existing steel pickling facilities are using hydrochloric acid and all 8 acid regeneration plants currently in operation, six of which are collocated with pickling facilities, are affected by this rule for a total of 70 sources. Based on further consultation with the EPA Office of Air Quality Planning and Standards ( OAQPS), we have determined that only one new source became subject to the standard over the period of the active Information Collection Request ( ICR) and, therefore, the current number of existing sources is 71 sources. We have also estimated that one additional source per year will become subject to the regulation over the next three years of this ICR. We have further assumed that all existing sources are in compliance with the regulation since the compliance date of this rule has passed and, therefore, the recordkeeping and reporting burden for this ICR will be higher.

For this information collection, we have addressed the Terms of Clearance set for the active ICR. We have accounted for the amortization of capital costs as discussed in Section 6( b)( iii) ( Capital/ Startup vs. Operation and Maintenance Costs) of this ICR and have revised the estimated number sources complying with this regulation over the next three years, as discussed above.

2. Need for and Use of the Collection 2( a) Need/ Authority for the Collection The EPA is charged under Section 112 of the Clean Air Act, as amended, to establish standards of performance for each category or subcategory of major sources and area sources of hazardous air pollutants. These standards are applicable to new or existing sources of hazardous air pollutants and shall require the maximum degree of emission reduction.

In addition, Section 114( a) states that the Administrator may require any owner or operator subject to any requirement of this Act to:

( A) Establish and maintain such records; ( B) make such reports; ( C) install, use, and maintain such monitoring equipment, and use such audit procedures, or methods; ( D) sample such emissions ( in accordance with such procedures or methods, at such locations, at such intervals, during such periods, and in such manner as the Administrator shall prescribe); ( E) keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical; ( F) submit compliance certifications in accordance with Section 114( a)( 3); and ( G) provide such other information as the Administrator may reasonably require.

In the Administrator's judgment, hydrochloric acid emissions from continuous and batch pickling lines and acid regeneration units and of chlorine emissions from acid regeneration units 3 cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, NESHAP were promulgated for this source category at 40 CFR Part 63, Subpart CCC.

2( b) Practical Utility/ Users of the Data The control of hydrochloric acid emissions from continuous and batch pickling lines and acid regeneration units and of chlorine emissions from acid regeneration units requires not only the installation of properly designed equipment, but also the operation and maintenance of that equipment. Emissions of hydrochloric acid from continuous and batch pickling lines and acid regeneration units and of chlorine emissions from acid regeneration units are the result of operation of the affected facilities. The subject standards are achieved by the capture and reduction of hydrochloric acid emissions and of chlorine emissions using closed vent systems at storage vessels and web scrubbers or other approved alternative control equipment. The notifications required in the applicable regulations are used to inform the Agency or delegated authority when a source becomes subject to the requirements of the regulations. The reviewing authority may then inspect the source to check if the pollution control devices are properly installed and operated and the regulations are being met. Performance test reports are needed as these are the Agency's record of a source's initial capability to comply with the emission standards, and serve as a record of the operating conditions under which compliance was achieved. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations. Adequate monitoring, recordkeeping, and reporting is necessary to ensure compliance with the applicable regulations, as required by the Clean Air Act. The information collected from recordkeeping and reporting requirements is also used for targeting inspections, and is of sufficient quality to be used as evidence in court.

3. Nonduplication, Consultations, and Other Collection Criteria The recordkeeping and reporting requested is required under 40 CFR Part 63, Subpart CCC.

3( a) Nonduplication If the subject standards have not been delegated, the information is sent directly to the appropriate EPA Regional Office. Otherwise, the information is sent directly to the delegated State or local agency. If a State or local agency has adopted their own similar standards to implement the Federal standards, a copy of the report submitted to the State or local agency can be sent to the Administrator in lieu of the report required by the Federal standards. Therefore, no duplication exists. 4 3( b) Public Notice Required Prior to ICR Submission to OMB An announcement of a public comment period for the renewal of this ICR was published in the Federal Register on October 29, 2001. No comments were received on the burden published in the Federal Register.

3( c) Consultations During the development of this rule, the EPA consulted with State and industry representatives including the three firms identified as potential small entities to discuss any potential issues. No major problems regarding monitoring, recordkeeping, or reporting procedures were identified. For this information collection, we conducted a query on the Facility Subsystem ( AFS) database of the Aerometric Information Retrieval System maintained by OAQPS. We also contacted the OAQPS lead staff for this rule.

3( d) Effects of Less Frequent Collection Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the standards. Requirements for information gathering and recordkeeping are useful techniques to ensure that good operation and maintenance practices are applied and emission limitations are met. If the information required by these standards was collected less frequently, the likelihood of detecting poor operation and maintenance of control equipment and noncompliance would decrease.

3( e) General Guidelines None of these reporting or recordkeeping requirements violate any of the regulations established by the Office of Management and Budget ( OMB) at 5 CFR 1320.6.

3( f) Confidentiality The required information consists of emissions data and other information that have been determined not to be private. However, any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in Title 40, Chapter 1, Part 2, Subpart B  Confidentiality of Business Information ( see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3( g) Sensitive Questions None of the reporting or recordkeeping requirements contain sensitive questions. 5 4. The Respondents and the Information Requested 4( a) Respondents/ SIC Codes The respondents to the recordkeeping and reporting requirements are facilities that pickle steel using hydrochloric acid or regenerate hydrochloric acid and are major sources or are part of a facility that is a major source. The SIC ( U. S. Standard Industrial Classification) codes for the respondents affected by 40 CFR Part 63, Subpart CCC and the corresponding NAICS ( The North American Industry Classification System) codes are listed below:

SIC Code and Description Corresponding NAICS Code and Description 3312  Steel Works, Blast Furnaces ( Including Coke Ovens), and Rolling Mills ( except coke ovens not integrated with steel mills 331111  Iron and Steel Mills; and 331221 Rolled Steel Shape Manufacturing 3315  Steel Wiredrawing and Steel Nails and Spikes ( steel, wire drawing) 331222  Steel Wire Drawing 3316  Cold Rolled Steel Sheet, Strip and Bars 331221  Rolled Steel Shape Manufacturing 3317  Steel Pipe and Tubes 33121  Iron and Steel Pipe and Tube Manufacturing from Purchased Steel 4( b) Information Requested ( i) Data Items All data in this ICR that is recorded and/ or reported is required by 40 CFR Part 63, Subpart CCC.

A source must make the following reports:

Reports for 40 CFR Part 63, Subpart CCC Construction/ reconstruction 63.5, 63.1163( a) 6 Reports for 40 CFR Part 63, Subpart CCC Initial notifications 63.9( b)

Anticipated start up 63.9( a), 63.1163( a)

Actual start up 63.9( a), 63.1163( a)

Initial performance test results 63.10( d)( 2), 63.1164( a)

Initial performance test 63.7( b), 63.9( e), 63.1163( d)

Rescheduled initial performance test 63.7( b)( 2)

Demonstration of continuous monitoring system, if applicable 63.9( g)

Request for an extension of compliance 63.9( c), 63.1163( b)

Compliance status 63.9( h), 63.1163( e)

Physical or operational change N/ A Opacity or visible emissions 63.10( d)( 3)

Progress Reports, if applicable 63.1164( b)

Periodic start up, shutdown, malfunction reports 63.10( d)( 5)( I), 63.1164( c)

A source must maintain the following records:

Recordkeeping for 40 CFR Part 63, Subpart CCC Start ups, shutdowns, malfunctions, periods where the continuous monitoring system is inoperative 63.10( b)( 2), 63.1165( a)

Emission test results and other data needed to determine emissions 61.13( g), 63.1165( a)( 7)

All reports and notifications 63.9, 63.10( b), 63.1165( a)( 10)

Record of applicability 63.10( b)( 3)

Records for sources with continuous monitoring systems 63.10( 3)

Records are required to be retained for 5 years. The first two years of records must be retained at the facility. 63.1165( a c) 7 Recordkeeping for 40 CFR Part 63, Subpart CCC Operation and manual plan 63.1165( b)

( ii.) Respondent Activities Respondent Activities Read instructions.

Owners of acid regeneration plants shall install, calibrate, maintain, and operate systems for the measurement of process offgas temperature, excess air proportion, make up water flow, and recirculation flow rate for web scrubbers or other parameters established during the performance test for an alternative control device.

Perform initial performance test, Reference Methods 1, 2, 3, 4 and 26A test or approved alternative method, and repeat performance tests if necessary.

Write the notifications and reports listed above.

Enter information required to be recorded above.

Submit the required reports developing, acquiring, installing, and utilizing technology and systems for the purpose of collecting, validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the purpose of processing and maintaining information.

Develop, acquire, install, and utilize technology and systems for the purpose of disclosing and providing information.

Adjust the existing ways to comply with any previously applicable instructions and requirements.

Train personnel to be able to respond to a collection of information.

Transmit, or otherwise disclose the information.

There is a trend in the industry toward using computer controlled operating systems that handle much of the data that had traditionally been handled by hand, which has significantly reduced the time needed to record and store data. Some delegated offices are setting up electronic reporting systems to enable facilities to report electronically, which is further reducing labor costs.

5. The Information Collected: Agency Activities, Collection Methodology, and Information 8 Management 5( a) Agency Activities EPA conducts the following activities in connection with the acquisition, analysis, storage, and distribution of the required information.

Agency Activities Observe initial performance tests and repeat performance tests if necessary.

Review notifications and reports, including performance test reports, emissions reports, maintenance plan and startup, shutdown and malfunction reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the AIRS ( Aerometric Information Retrieval System) Facility Subsystem ( AFS) database.

5( b) Collection Methodology and Management Following notification of start up, the reviewing authority might inspect the source to determine whether the pollution control devices are properly installed and operated. Performance test reports are used by the Agency to discern a source's initial capability to comply with the emission standard. Data and records maintained by the respondents are tabulated and published for use in compliance and enforcement programs. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations.

Information contained in the reports is entered into AFS which is operated and maintained by EPA's Office of Air Quality Planning and Standards. AFS is EPA's database for the collection, maintenance, and retrieval of compliance and annual emission inventory data for over 100,000 industrial and government owned facilities. EPA uses AFS for tracking air pollution compliance and enforcement by Local and State regulatory agencies, EPA Regional Offices and EPA Headquarters. EPA and its delegated Authorities can edit, store, retrieve and analyze the data.

The records required by this regulation must be retained by the owner or operator for five years.

5( c) Small Entity Flexibility During the development of the NESHAP for steel pickling, it was determined that there are no small businesses that would be subject to the NESHAP or incur adverse economic impacts. For firms that are not small entities by this definition, the rule provides flexibility to the regulated community in the choice of emission limits or performance standards. Provisions also are included to allow additional time to comply if needed for the installation of capture or control equipment. 9 5( d) Collection Schedule The specific frequency for each information collection activity within this request is shown in Table 2: Industry Burden.

6. Estimating the Burden and Cost of the Collection Table 2 documents the computation of individual burdens for the recordkeeping and reporting requirements applicable to the industry for the Subpart included in this ICR. The individual burdens are expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act. Where appropriate, specific tasks and major assumptions have been identified. Responses to this information collection are mandatory.

The Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

6( a) Estimating Respondent Burden The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated to be 25,103.92 ( Total Labor Hours from Table 1). These hours are based on Agency studies and background documents from the development of the regulation, Agency knowledge and experience with the NESHAP program, the previously approved ICR, and any comments received.

6( b) Estimating Respondent Costs ( i) Estimating Labor Costs This ICR uses the following labor rates: $ 78.54 per hour for Executive, Administrative, and Managerial labor; $ 55.34 per hour for Technical labor, and $ 35.64 per hour for Clerical labor. These rates are from the United States Department of Commerce Bureau of Labor Statistics, March 2000, " Table 10. Private industry, by occupational and industry group." The rates are from column 1, " Total compensation." The wage rates have been increased by 110% to account for the benefit packages available to those employed by private industry.

Managerial $ 78.54 ($ 37.40 + 110%) Technical $ 55.34 ($ 26.35 + 110%) Clerical $ 35.64 ($ 16.97 + 110%)

( ii) Estimating Capital/ Startup and Operation and Maintenance Costs The types of industry costs associated with the information collection activity in the regulations are labor and continuous emission monitors ( CEMs) for flow meters. The capital/ startup costs are one time costs when a facility becomes subject to the regulation. The 10 annual operation and maintenance costs are the ongoing costs to maintain the monitor and other costs such as photocopying and postage.

( iii) Capital/ Startup vs. Operation and Maintenance ( O& M) Costs This estimate includes the cost of equipment, parts, energy consumption and contracted maintenance labor.

Capital/ Startup vs. Operation and Maintenance ( O& M) Costs ( A) Continuous Monitoring Device ( B) Startup Cost ($) for One Affected Facility ( C) No. of New Affected Facilities to Startup ( D) Total* Startup ( B X C) ( E) Annual O& M Costs ($) for One Affected Facility ( F) No. of Affected Facilities with O& M ( G) Total O& M**

( E X F) ( H)

Total Annualize d Cost Flowmeters with high/ low alarms $ 830 1 $ 830 $ 106 71.3 $ 7,558 $ 8,388 * One new source will buy two recording flowmeters with high/ low alarms and supporting equipment. ** All existing sources have O& M costs associated with two recording flowmeters with high/ low alarms which have a lifetime of 15 years. Because all sources are assumed to measure and record routinely certain parameters, no further costs are assumed. All plants are assumed to have and operate technology and systems that interface with monitoring equipment. The plants do not require significant new resources for their utilization.

The total capital/ startup costs for this ICR are $ 830. This is the total of column D in the above table. These costs are shown in block 14( a), Total annualized capital/ startup costs, on the OMB 83 I form. It should be noted that the numbers in block 14 of the OMB 83 I form are show the cost in thousands of dollars.

The total operation and maintenance ( O& M) costs for this ICR are $ 7,558. This is the total of column G. These costs are shown in block 14( b), Total annual costs ( O& M), on the OMB 83 I form.

The total respondent non labor costs in block 14 have been calculated as the addition of the capital/ startup costs, and the annual operation and maintenance costs. The average annual cost for capital/ startup and operation and maintenance to industry over the next three years of the ICR is estimated to be $ 8,388. This is the total of column H. This cost is shown on the OMB 83 I form in block 14 ( c), Total Annualized Cost requested. The numbers in block 14 of the OMB 83 I form show the cost in thousands of dollars.

6( c) Estimating Agency Burden and Cost 11 The only costs to the Agency are those costs associated with analysis of the reported information. Publication and distribution of the information are part of the AFS program. Examination of records to be maintained by the respondents will occur as part of the periodic inspection of sources, which is part of EPA's overall compliance and enforcement program.

The average annual Agency cost during the 3 years of the ICR is estimated to be $ 99,335.51 [ see Table 2 in Section 6( e)]. This cost is based on the average hourly labor rates specified by the Office of Personnel Management " 2002 General Schedule" ( excludes locality rates of pay) for the managerial, technical and clerical categories times a 1.6 benefits multiplication factor to account for government overhead expenses as described below:

Managerial $ 51.62 ( GS 13, Step 5, $ 32.26 x 1.6) Technical $ 38.30 ( GS 12, Step 1, $ 23.94 x 1.6) Clerical $ 20.72 ( GS 6, Step 3, $ 12.95 x 1.6)

Details upon which this estimate is based appear in Table 1, below.

6( d) Estimating the Respondent Universe and Total Burden and Costs Respondent Universe Regulation Citation ( A) Number of New Sources per Year ( B) Number of Initial Reports for New Sources ( C) Number of Existing Sources ( D) Number of Reports for Existing Sources ( E) Total Annual Responses ( AxB)+( CxD)

40 CFR Part 60, Subpart CCC 0.3 10 71 3.21 231 ( 3+ 227.7)

The number of total respondents is 71.3. This number is the sum of Column A and Column C of the Respondent Universe table. This represents the number of existing sources plus the number of new sources averaged over the three year period. It is shown in block 13 ( a), Number of respondents, on the OMB 83 I form.

The number of Total Annual Responses is 231. This is the number in column E of the Respondent Universe table. It is shown in block 13 ( b), Total annual responses, on the OMB 83 I form. The total annual labor costs are $ 1,372,289.00. This number is not shown on the OMB 83 I form in block 13( c), Total hours requested. Only the burden hours are reflected in block 13( c). Details upon which this estimate is based appear in Table 1. Annual Respondent Burden and Cost.

The total annual capital and O& M costs to the regulated entity are $ 8,388. This number is shown on the OMB 83 I form in block 14 ( c), Total annualized cost requested. These costs are detailed in section 6( b)( iii), Capital/ Startup vs. Operating and Maintenance ( O& M) Costs. 12 6( e) Bottom Line Burden Hours Burden Hours And Cost Tables The bottom line burden hours and cost tables for both the Agency and the respondents appear are attached.

6( f) Reasons for Change in Burden The increase in burden from the most recently approved ICR is due to an adjustment. The adjustment increase in burden from the most recently approved ICR is due to the assumptions that all existing sources would be in full compliance with this regulation by the compliance due date established by the rule ( June 2001) and no source has asked for an extension of the compliance date that would fall under the time period of this ICR. These assumptions result in more responses per year over the three year period of this new ICR due to having all existing sources complying with the recordkeeping and reporting requirements for this rule. In addition, the cost associated with this ICR would be affected by more accurate estimates of the technical, management and clerical hourly labor rates for the industry sector, as well as for government.

6( g) Burden Statement Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's standards are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Ms. Susan Auby, Collection Strategies Division ( Mail Code 2822T), Office of Environmental Information, United States Environmental Protection Agency, 1200 Pennsylvania Avenue, NW, Washington, D. C. 20460 0001; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Include the EPA ICR number and OMB Control Number in any correspondence.

Part B of the Supporting Statement This part is not applicable because no statistical methods were used in collecting this information.


[Federal Register: March 27, 2007 (Volume 72, Number 58)]
[Notices]
[Page 14268]
[DOCID:fr27mr07-25]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-354-000]

El Paso Natural Gas Company; Notice of Proposed Changes in FERC
Gas Tariff

March 21, 2007.
    Take notice that on March 16, 2007, El Paso Natural Gas Company
(EPNG) tendered for filing as part of its FERC Gas Tariff, Second
Revised Volume No. 1-A, the following tariff sheets to become effective
April 16, 2007:

Third Revised Sheet No. 424
Second Revised Sheet No. 480C
Second Revised Sheet No. 482C
Second Revised Sheet No. 483C
Second Revised Sheet No. 485C

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

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

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

TTY, call<PHONE_NUMBER>.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-5523 Filed 3-26-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 187 (Tuesday, September 27, 2011)]
[Proposed Rules]
[Page 59599]
[FR Doc No: 2011-24856]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 50

[EPA-HQ-OAR-2007-1145; FRL-9471-7]
RIN 2060-AO72

Extension of Comment Period for Secondary National Ambient Air
Quality Standards for Oxides of Nitrogen and Sulfur

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of extension of public comment period.

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SUMMARY: The EPA is announcing the extension of the public comment
period for the Secondary National Ambient Air Quality Standards for
Oxides of Nitrogen and Sulfur to October 10, 2011.

DATES: The public comment period will be extended to October 10, 2011.

ADDRESSES: Written comments on this proposed rule may be submitted to
the EPA electronically, by mail, by facsimile, or through hand
delivery/courier.
    Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2007-
1145, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Docket No. EPA-HQ-OAR-2007-1145, Environmental
Protection Agency, Mail code 6102T, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. Please include a total of two copies.
     Hand Delivery: Docket No. EPA-HQ-OAR-2007-1145,
Environmental Protection Agency, EPA West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2007-1145. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

Docket

    A complete set of documents related to the proposal is available
for public inspection at the EPA Docket Center, located at 1301
Constitution Avenue, NW., Room 3334, Washington, DC between 8:30 a.m.
and 4:30 p.m., Monday through Friday, excluding legal holidays. A
reasonable fee may be charged for copying. Documents are also available
through the electronic docket system at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Questions concerning the ``Secondary
National Ambient Air Quality Standards for Oxides of Nitrogen and
Sulfur'' proposed rule should be addressed to Rich Scheffe, U.S. EPA,
Office of Air Quality Planning and Standards, Air Quality Assessment
Division, (C304-02), Research Triangle Park, NC 27711, telephone: (919)
541-4650, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Extension of public comment period. The EPA has received requests
for additional time from stakeholders and has decided to extend the
comment period by 10 days to allow interested parties to have
additional time to prepare their comments. The proposal was published
in the Federal Register on August 1, 2011, (76 FR 46084) and is
available on the following Web site: http://www.epa.gov/ttn/naaqs/standards/no2so2sec/cr_fr.html.

How can I get copies of this document and other related information?

    The EPA has established the official public docket for the
``Secondary National Ambient Air Quality Standards for Oxides of
Nitrogen and Sulfur'' under Docket Number EPA-HQ-OAR-2007-1145. The EPA
has also developed a Web site for the proposal at the address given
above. Please refer to the proposal, published in the Federal Register
on August 1, 2011, (76 FR 46084) for detailed information on accessing
information related to the proposal.

    Dated: September 21, 2011.
Mary Henigin,
Acting Director, Office of Air Quality Planning and Standards.
[FR Doc. 2011-24856 Filed 9-26-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 16 (Tuesday, January 25, 2022)]
[Proposed Rules]
[Pages 3716-3719]
[FR Doc No: 2022-01352]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0011; Project Identifier MCAI-2021-00485-T]
RIN 2120-AA64

Airworthiness Directives; MHI RJ Aviation ULC (Type Certificate
Previously Held by Bombardier, Inc.) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain MHI RJ Aviation ULC Model CL-600-2B19 (Regional Jet Series
100 & 440) airplanes, Model CL-600-2C10 (Regional Jet Series 700, 701 &
702) airplanes, Model CL-600-2C11 (Regional Jet Series 550) airplanes,
Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-
2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25
(Regional Jet Series 1000) airplanes. This proposed AD was prompted by
reports of corrosion on fuel clamshell couplings installed in the fuel
tank, and a determination that new or more restrictive airworthiness
limitations are necessary. This proposed AD would require removing and
replacing the fuel clamshell couplings on certain airplanes, and
revising the existing maintenance or inspection program, as applicable,
to incorporate new or more restrictive airworthiness limitations. The
FAA is proposing this AD to address the unsafe condition on these
products.

DATES: The FAA must receive comments on this proposed AD by March 11,
2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact MHI RJ
Aviation ULC, 12655 Henri-Fabre Blvd., Mirabel, Qu[eacute]bec J7N 1E1
Canada; Widebody Customer Response Center North America toll-free
telephone +1-844-272-2720 or direct-dial telephone +1-514-855-8500; fax
+1-514-855-8501; email [email protected]; internet https://mhirj.com.
You may view this service information at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St., Des
Moines, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-
0011; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Jiwan Karunatilake, Aerospace
Engineer, Airframe and Propulsion Section, FAA, New York ACO Branch,
1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-
7300; fax<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-0011; Project Identifier
MCAI-2021-00485-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
the proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this proposed AD.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Jiwan
Karunatilake, Aerospace Engineer, Airframe and Propulsion Section, FAA,
New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY
11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email [email protected]. Any commentary that the FAA receives which is not
specifically designated as CBI will be placed in the public docket for
this rulemaking.

Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued TCCA AD CF-2021-16, dated April 26,
2021 (TCCA AD CF-2021-16) (also referred to after this as the Mandatory
Continuing Airworthiness Information, or the MCAI), to correct an
unsafe condition for certain MHI RJ Aviation ULC Model CL-600-2B19
(Regional Jet Series 100 & 440) airplanes, Model CL-600-2C10 (Regional
Jet Series 700, 701 & 702) airplanes, Model CL-600-2C11 (Regional Jet
Series 550) airplanes, Model CL-600-2D15 (Regional Jet Series 705)
airplanes, Model CL-600-2D24 (Regional Jet Series 900) airplanes, and
Model CL-600-2E25 (Regional Jet Series 1000) airplanes. You may examine
the MCAI in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-
0011.
    This proposed AD was prompted by reports of corrosion on fuel
clamshell couplings installed in the fuel tank, and a determination
that new or more restrictive airworthiness limitations are necessary.
The FAA is proposing this AD to address corroded fuel clamshell
couplings in the fuel tank, which, if not removed and replaced, could
reduce the ability of the fuel coupling to conduct

lightning current and possibly lead to arcing and subsequent fuel tank
ignition in the event of a lightning strike. See the MCAI for
additional background information.

Related Service Information Under 1 CFR Part 51

    MHI RJ Aviation has issued Service Bulletin 601R-28-068, Revision
A, dated December 21, 2020; and Service Bulletin 670BA-28-041, Revision
B, dated January 27, 2021. This service information describes
procedures for removing and replacing the fuel clamshell couplings.
These documents are distinct because they apply to different airplane
models.
    MHI RJ Aviation has also issued Temporary Revision (TR) 2S4-002,
dated September 1, 2021. This service information describes a Critical
Design Configuration Control Limitations (CDCCL) item for bonding of
fuel and vent lines for lightning protection to preclude a spark.
    MHI RJ Aviation has also issued the following TRs, which describe
airworthiness limitations for fuel tank systems.
     TR 2S4-003, dated September 1, 2021; CRJ Series Regional
Jet TR ALI-0741, dated October 13, 2020; and CRJ700/900/1000 Series
Regional Jet TR ALI-0751, dated April 8, 2021, describe a procedure for
removing and replacing self-bonding couplings in the fuel tank.
     CRJ Series Regional Jet TR ALI-0740, dated October 13,
2020, describes a CDCCL item for bonding of fuel and vent lines for
lightning protection to preclude a spark.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination

    These products have been approved by the aviation authority of
another country, and are approved for operation in the United States.
Pursuant to the FAA's bilateral agreement with the State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI and service information referenced above. The FAA is issuing
this NPRM after determining that the unsafe condition described
previously is likely to exist or develop in other products of these
same type designs.

Proposed Requirements of This NPRM

    This proposed AD would require removing and replacing the fuel
clamshell couplings on certain airplanes and revising the existing
maintenance or inspection program, as applicable, to incorporate new or
more restrictive airworthiness limitations.
    This proposed AD would require revisions to certain operator
maintenance documents to include new actions (e.g., inspections) and
CDCCLs. Compliance with these actions and CDCCLs is required by 14 CFR
91.403(c). For airplanes that have been previously modified, altered,
or repaired in the areas addressed by this proposed AD, the operator
may not be able to accomplish the actions described in the revisions.
In this situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance according to
paragraph (m)(1) of this proposed AD.

Differences Between This Proposed AD and the MCAI or Service
Information

    The MCAI specifies to revise the CDCCL Items as introduced by
Bombardier CL-600-2B19 TR 2D-009, dated October 24, 2020, in Appendix
D--Fuel Systems Limitations of Part 2, Airworthiness Requirements, of
the MHI RJ Maintenance Requirements Manual (MRM). This proposed AD does
not require this action because the TR references Appendix D--Fuel
Systems Limitations of Part 2, Airworthiness Requirements, of the MHI
RJ MRM, which is not applicable to U.S. airplanes. As a result, this
proposed AD would require that the information specified in MHI RJ TR
2S4-002, dated September 1, 2021, is incorporated into Supplement 4--
FAA Fuel System Limitations of Part 2, Airworthiness Requirements, of
the MHI RJ MRM as required by paragraph (h)(1) of this proposed AD. MHI
RJ TR 2S4-002, dated September 1, 2021, addresses the unsafe condition
with references that apply to U.S. airplanes and provides the same or
better level of safety.
    The MCAI also specifies to incorporate the new Fuel System
Limitation Task 28-23-00-605 as introduced by Bombardier CL-600-2B19 TR
2D-008, dated October 24, 2020; and to revise the Task Description
Effectivity as amended by Bombardier CL-600-2B19 TR 2D-010, dated April
8, 2021; in Appendix D--Fuel Systems Limitations of Part 2,
Airworthiness Requirements, of the MHI RJ MRM. This proposed AD does
not require these actions because these TRs also reference Appendix D--
Fuel Systems Limitations of Part 2, Airworthiness Requirements, of the
MHI RJ MRM, which is not applicable to U.S. airplanes. As a result,
this proposed AD would require that the information specified in MHI RJ
TR 2S4-003, dated September 1, 2021, is incorporated into Supplement
4--FAA Fuel System Limitations of Part 2, Airworthiness Requirements,
of the MHI RJ MRM, as specified in paragraph (h)(2) of this proposed
AD. MHI RJ TR 2S4-003, dated September 1, 2021, addresses the unsafe
condition with references that apply to U.S. airplanes and provides the
same or better level of safety.

Costs of Compliance

    The FAA estimates that this proposed AD affects 914 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                     Estimated Costs for Required Actions *
----------------------------------------------------------------------------------------------------------------
           Labor cost                   Parts cost           Cost per product         Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Up to 21 work-hours x $85 per     Up to $5,837..........  Up to $7,622..........  Up to $6,966,508.
 hour = $1,785.
----------------------------------------------------------------------------------------------------------------
* Table does not include estimated costs for revising the maintenance/inspection program.

    The FAA has determined that revising the maintenance or inspection
program takes an average of 90 work-hours per operator, although the
FAA recognizes that this number may vary from operator to operator. In
the past, the FAA has estimated that this action takes 1 work-hour per
airplane. Since operators incorporate maintenance or inspection program
changes for their affected fleet(s), the FAA has determined that a per-
operator estimate is more accurate than a per-airplane estimate.
Therefore, the FAA estimates the total cost per operator to be $7,650
(90 work-hours x $85 per work-hour).
    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected individuals. The FAA does not control warranty
coverage for affected individuals. As a result, the FAA has

included all known costs in the cost estimate.

Authority for This Rulemaking

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

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

MHI RJ Aviation ULC (Type Certificate Previously Held by Bombardier,
Inc.): Docket No. FAA-2022-0011; Project Identifier MCAI-2021-00485-
T.

(a) Comments Due Date

    The FAA must receive comments by March 11, 2022.

(b) Affected Airworthiness Directives (ADs)

    None.

(c) Applicability

    This AD applies to the MHI RJ Aviation ULC airplanes,
certificated in any category, identified in paragraphs (c)(1)
through (4) of this AD.
    (1) Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes,
serial numbers 7002 through 7990 inclusive and 8000 through 8112
inclusive.
    (2) Model CL-600-2C10 (Regional Jet Series 700, 701 & 702) and
CL-600-2C11 (Regional Jet Series 550) airplanes, serial numbers
10002 through 10347 inclusive.
    (3) Model CL-600-2D15 (Regional Jet Series 705) and CL-600-2D24
(Regional Jet Series 900) airplanes, serial numbers 15001 through
15499 inclusive.
    (4) Model CL-600-2E25 (Regional Jet Series 1000) airplanes,
serial numbers 19001 through 19064 inclusive.

(d) Subject

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

(e) Reason

    This AD was prompted by reports of corrosion on fuel clamshell
couplings installed in the fuel tank, and a determination that new
or more restrictive airworthiness limitations are necessary. The FAA
is issuing this AD to address corroded fuel clamshell couplings in
the fuel tank, which, if not removed and replaced, could reduce the
ability of the fuel coupling to conduct lightning current and
possibly lead to arcing and subsequent fuel tank ignition in the
event of a lightning strike.

(f) Compliance

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

(g) Clamshell Coupling Replacement: Model CL-600-2B19 Airplanes

    For Model CL-600-2B19 airplanes: Within 6,600 flight hours or 36
months, whichever occurs first after the effective date of this AD,
remove and replace the fuel clamshell couplings, in accordance with
Section 2.B. of the Accomplishment Instructions of MHI RJ Service
Bulletin 601R-28-068, Revision A, dated December 21, 2020.

(h) Revision of the Existing Maintenance or Inspection Program: Model
CL-600-2B19 Airplanes

    For Model CL-600-2B19 airplanes: Within 60 days after the
effective date of this AD, revise the existing maintenance or
inspection program, as applicable, to incorporate the information
specified in paragraphs (h)(1) and (2) of this AD into Supplement
4--FAA Fuel System Limitations of Part 2, Airworthiness
Requirements, of the MHI RJ Maintenance Requirements Manual (MRM).
    (1) Critical Design Configuration Control Limitation (CDCCL)
Item as specified in MHI RJ Temporary Revision (TR) 2S4-002, dated
September 1, 2021.
    (2) Fuel System Limitation Task 28-23-00-605 as specified in MHI
RJ TR 2S4-003, dated September 1, 2021.

(i) Clamshell Coupling Replacement: Model CL-600-2C10, CL-600-2C11, CL-
600-2D15, CL-600-2D24, and CL-600-2E25 Airplanes

    For Model CL-600-2C10 and CL-600-2C11 airplanes; Model CL-600-
2D15 and CL-600-2D24 airplanes, serial numbers 15001 through 15494
inclusive; and Model CL-600-2E25 airplanes: Within 8,800 flight
hours or 48 months, whichever occurs first after the effective date
of this AD, replace the fuel clamshell couplings, in accordance with
Section 2.B. of the Accomplishment Instructions of MHI RJ Service
Bulletin 670BA-28-041, Revision B, dated January 27, 2021.

(j) Revision of the Existing Maintenance or Inspection Program: Model
CL-600-2C10, CL-600-2C11, CL-600-2D15, CL-600-2D24, and CL-600-2E25
Airplanes

    For Model CL-600-2C10, CL-600-2C11, CL-600-2D15, CL-600-2D24,
and CL-600-2E25 airplanes: Within 60 days after the effective date
of this AD, revise the existing maintenance or inspection program,
as applicable, to incorporate the information specified in
paragraphs (j)(1) and (2) of this AD.
    (1) Fuel System Limitation Task 28-21-15-601 as specified in
[MHI RJ] CRJ Series Regional Jet TR ALI-0741, dated October 13,
2020; and Description Applicability for Airworthiness Limitation
Task 28-21-15-601 as amended by [MHI RJ] CRJ700/900/1000 Series
Regional Jet TR ALI-0751, dated April 8, 2021; in Section 4-28 of
Part 2, Airworthiness Requirements, of the MHI RJ MRM.
    (2) CDCCL Item as specified in [MHI RJ] CRJ Series Regional Jet
TR ALI-0740, dated October 13, 2020, in Section 5-00 of Part 2,
Airworthiness Requirements, of the MHI RJ MRM.

(k) No Alternative Actions, Intervals, or CDCCLs

    After the existing maintenance or inspection program has been
revised as required by paragraphs (h) and (j) of this AD, no
alternative actions (e.g., inspections), intervals, or CDCCLs may be
used unless the actions, intervals, and CDCCLs are approved as an
alternative method of compliance (AMOC) in accordance with the
procedures specified in paragraph (m)(1) of this AD.

(l) Credit for Previous Actions

    (1) This paragraph provides credit for actions required by
paragraph (g) of this AD, if those actions were performed before the
effective date of this AD using MHI RJ

Service Bulletin 601R-28-068, dated December 3, 2020.
    (2) This paragraph provides credit for actions required by
paragraph (i) of this AD, if those actions were performed before the
effective date of this AD using MHI RJ Service Bulletin 670BA-28-
041, dated December 3, 2020; or Revision A, dated December 21, 2020.

(m) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or responsible Flight Standards Office, as appropriate. If
sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before
using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or Transport Canada Civil Aviation (TCCA); or MHI RJ
Aviation ULC's TCCA Design Approval Organization (DAO). If approved
by the DAO, the approval must include the DAO-authorized signature.

(n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) TCCA AD CF-2021-16, dated April 26, 2021, for related
information. This MCAI may be found in the AD docket on the internet
at https://www.regulations.gov by searching for and locating Docket
No. FAA-2022-0011.
    (2) For more information about this AD, contact Jiwan
Karunatilake, Aerospace Engineer, Airframe and Propulsion Section,
FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury,
NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email [email protected].
    (3) For service information identified in this AD, contact MHI
RJ Aviation ULC, 12655 Henri-Fabre Blvd., Mirabel, Qu[eacute]bec J7N
1E1 Canada; Widebody Customer Response Center North America toll-
free telephone +1-844-272-2720 or direct-dial telephone +1-514-855-
8500; fax +1-514-855-8501; email [email protected]; internet https://mhirj.com. You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.

    Issued on January 19, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-01352 Filed 1-24-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: June 8, 2010 (Volume 75, Number 109)]
[Notices]
[Page 32458]
[DOCID:fr08jn10-83]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL10-69-000]

Virginia Electric and Power Company v. PJM Interconnection, LLC;
Notice of Complaint

May 28, 2010.
    Take notice that on May 25, 2010, pursuant to Rule 206 of the Rules
of Practice and Procedure of the Federal Energy Regulatory Commission
(Commission), 18 CFR 385.206, Virginia Electric and Power Company
(Complainant) filed a formal complaint against PJM Interconnection, LLC
(Respondent), alleging that the Respondent erroneously changed its load
forecast model for 2010 for the Dominion zone.
    Complainant certifies that copies of the complaint were served on
the contacts for the Respondent, as listed on the Commission's list of
Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on June 14, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-13555 Filed 6-7-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 125 (Friday, July 2, 2021)]
[Notices]
[Pages 35302-35303]
[FR Doc No: 2021-14201]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-0420]

Providing Regulatory Submissions in Alternate Electronic Format;
Guidance for Industry; 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 for industry entitled ``Providing
Regulatory Submissions in Alternate Electronic Format.'' Under the
Federal Food, Drug, and Cosmetic Act (FD&C Act), Congress granted FDA
the authority to implement the statutory electronic submission
requirements in guidance. In response, FDA implemented binding guidance
requiring that new drug applications (NDAs), abbreviated new drug
applications (ANDAs), certain drug master files (DMFs), certain
biologics license applications (BLAs), and certain investigational new
drug applications (INDs) be submitted to the Agency in electronic
common technical document format. Recognizing that some submissions are
exempt from this requirement and that waivers of the requirement may be
granted on a case-by-case basis, the Agency is issuing this guidance to
provide recommendations on an alternate electronic format for
submissions covered under such exemptions and waivers. This guidance
replaces the draft guidance of the same title issued on March 11, 2020.

DATES: The announcement of the guidance is published in the Federal
Register on July 2, 2021.

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-2020-D-0420 for ``Providing Regulatory Submissions in Alternate
Electronic Format.'' 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, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available

for public viewing and posted on https://www.regulations.gov. Submit
both copies to the Dockets Management Staff. If you do not wish your
name and contact information to be made publicly available, you can
provide this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Dat Doan, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 3334, 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 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Providing Regulatory Submissions in Alternate Electronic
Format.'' This guidance provides recommendations on an alternate
electronic format for submissions that are covered under an exemption
from or granted a waiver of the requirements of section 745A(a) of the
FD&C Act (21 U.S.C. 379k-1). These recommendations pertain to the
electronic format of content in NDAs, ANDAs, certain DMFs, certain
BLAs, and certain INDs submitted to the Center for Drug Evaluation and
Research or to the Center for Biologics Evaluation and Research.
    This guidance includes information on: (1) How to submit in
alternate electronic format (without XML backbone), (2) submission of
FDA forms, (3) pre-submission considerations, (4) submission structure,
(5) file formats and versions, (6) datasets and study information, (7)
transmitting electronic submissions, and (8) receipt dates.
    This guidance finalizes the draft guidance of the same title issued
on March 11, 2020 (85 FR 14202). FDA considered comments received on
the draft guidance as the guidance was finalized. Changes from the
draft to final guidance include: (1) Minor edits to clarify
recommendations for the location of the Table of Contents for the
alternate electronic format, (2) an example of the folder structure,
and (3) the process for submission if an electronic signature is not
possible. In addition, editorial changes were made to improve clarity.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). This final guidance represents
FDA's current thinking on ``Providing Regulatory Submissions in
Alternate Electronic Format.'' 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.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 have been approved under OMB control
number 0910-0014; the collections of information in 21 CFR part 314
have been approved under OMB control number 0910-0001; and the
collections of information in 21 CFR part 601 have been approved under
OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or
https://www.regulations.gov.

    Dated: June 28, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14201 Filed 7-1-21; 8:45 am]
BILLING CODE 4164-01-P


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