[Federal Register Volume 76, Number 109 (Tuesday, June 7, 2011)]
[Notices]
[Pages 33014-33015]
[FR Doc No: 2011-13994]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64583; File No. SR-BX-2011-031]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by NASDAQ OMX BX, Inc. To Amend
the Fee Schedule of BOX

June 2, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\, and Rule 19b-4 thereunder,\2\ notice is hereby given
that on May 31, 2011, NASDAQ OMX BX, Inc. (the ``Exchange'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I and II, below, which Items have
been prepared by the self-regulatory organization. The Exchange filed
the proposed rule change pursuant to Section 19(b)(3)(A)(ii) of the
Act,\3\ and Rule 19b-4(f)(2) thereunder,\4\ which renders the proposal
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Fee Schedule of the Boston
Options Exchange Group, LLC (``BOX'').\5\ While changes to the BOX Fee
Schedule pursuant to this proposal will be effective upon filing, the
changes will become operative on June 1, 2011. The text of the proposed
rule change is available from the principal office of the Exchange, at
the Commission's Public Reference Room, and also on the Exchange's
Internet Web site at http://nasdaqomxbx.cchwallstreet.com/NASDAQOMXBX/Filings.
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    \5\ The BOX Fee Schedule can be found on the BOX Web site at
http://bostonoptions.com/pdf/BOX_Fee _Schedule.pdf.
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

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

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

1. Purpose
    The Exchange proposes an amendment to the BOX Fee Schedule to
increase the number of contracts per month of Eligible Orders that BOX
will route to Away Exchanges before assessing a $0.50 per contract fee.
BOX currently exempts outbound Eligible Orders routed to Away
Exchanges, up to a maximum of 4,000 contracts per month, from the fees
and credits of Section 7 of the BOX Fee Schedule, as these transactions
are deemed to neither `add' nor `take' liquidity from the BOX Book.\6\
Additionally, Section 8 of the BOX Fee Schedule currently imposes a fee
of $0.50 per contract for all Eligible Orders routed to Away Exchanges
in excess of 4,000 contracts per month for an individual BOX Options
Participant.\7\ The Exchange proposes to raise this maximum for the
exemption in Section 7 and the fee assessment in Section 8 to 10,000
contracts per month, per Options Participant.
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    \6\ See Securities Exchange Act Release No. 60504 (August 14,
2009), 74 FR 42724 (August 24, 2009) (SR-BX-2009-047).
    \7\ See Securities Exchange Act Release No. 60610 (September 1,
2009), 74 FR 46285 (September 8, 2009) (SR-BX-2009-058). The
proposed change will have no effect on the billing of orders of non-
BOX Options Participants.
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2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act,\8\ in general, and Section
6(b)(4) of the Act,\9\ in particular, in that it provides for the
equitable allocation of reasonable dues, fees, and other charges among
BOX Participants and other persons using its facilities.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(4).
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    The Exchange believes that it is equitable to permit BOX
Participants to have orders routed to away exchanges without being
assessed a fee, up to a maximum of 10,000 contracts per month. Each BOX
Participant will then be assessed a $0.50 per contract fee for orders
routed to away exchanges beyond 10,000 contracts per month. The
Exchange believes that increasing this maximum will attract additional
order flow to BOX to the benefit of all market participants. The
Exchange believes that it is an equitable allocation of the fees
because the order routing fee structure applies to all BOX
Participants.
    Further, the Exchange believes the proposed change and its
resulting order routing fees are fair and reasonable and must be
competitive with similar fees in place on other exchanges. BOX operates
within a highly competitive market in which market participants can
readily direct order flow to any of eight other competing venues if
they deem fee levels at a particular venue to be excessive. The change
to allow BOX Participants to have more orders routed away at no cost is
intended to attract order flow to BOX and provide BOX Participants
additional flexibility in their execution decisions. The Exchange
believes all market participants can benefit from greater liquidity on
BOX and that it is appropriate to provide a fee structure intended to
attract additional order flow. In particular, the proposed change will
allow BOX to remain competitive with other exchanges, allow BOX to
assess the appropriate fees with respect to orders routed to away
exchanges, and to apply such fees in a manner which is equitable among
all BOX Participants. The Exchange believes that this competitive
marketplace impacts the fees present on BOX today and influences this
proposal.

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

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

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

    The Exchange has neither solicited nor received comments on the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \10\ and Rule 19b-4(f)(2) thereunder,\11\
because it establishes or changes a due, fee, or other charge
applicable only to a member.
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    \10\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \11\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such

action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BX-2011-031 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BX-2011-031. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NW.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. The text of the proposed rule change is available on
the Commission's Web site at http://www.sec.gov. Copies of such filing
also will be available for inspection and copying at the principal
office of the Exchange. All comments received will be posted without
change; the Commission does not edit personal identifying information
from submissions. You should submit only information that you wish to
make available publicly. All submissions should refer to File Number
SR-BX-2011-031 and should be submitted on or before June 28, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-13994 Filed 6-6-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 111 (Monday, June 10, 2019)]
[Rules and Regulations]
[Pages 26743-26746]
[FR Doc No: 2019-12221]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0409; Product Identifier 2019-NM-092-AD; Amendment
39-19649; AD 2019-11-03]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: The FAA is adopting an airworthiness directive (AD) for
certain The Boeing Company Model 737-700C, -800, and -900ER series
airplanes. This AD requires a maintenance records check to determine if
any main slat track assembly has been removed, an inspection of the
main slat track assemblies for a suspect lot number or a lot number
that cannot be determined, and applicable on-condition actions. This AD
was prompted by a report that certain main slat track assemblies were
manufactured incorrectly and are affected by hydrogen embrittlement.
The FAA is issuing this AD to address the unsafe condition on these
products.

DATES: This AD is effective June 10, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of June 10,
2019.
    The FAA must receive comments on this AD by July 25, 2019.

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 http://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 AD, contact Boeing
Commercial Airplanes, Attention: Contractual & Data Services (C&DS),
2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600;
telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may
view this referenced service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>. It
is also available on the internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2019-0409.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0409; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this final rule, the regulatory evaluation, 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: Greg Rutar, Aerospace Engineer,
Airframe Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des
Moines, WA 98198; phone and fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The FAA has received a report from Boeing indicating that 148 main
slat track assemblies from a set of lot numbers were manufactured
incorrectly and are affected by hydrogen embrittlement. Main slat track
assemblies that are affected by hydrogen embrittlement have reduced
strength. After reviewing information within the report provided from
Boeing, the FAA determined on May 22, 2019, that this condition, if not
addressed, could result in failure of main slat track assemblies, which
could cause the slat to depart and potentially strike the airplane,
resulting in injury to airplane occupants and/or preventing continued
safe flight and landing.

Other Relevant Potential Rulemaking

    The FAA has determined that the identified unsafe condition also
exists on Boeing Model 737-8 and -9 (737 MAX) airplanes. Boeing is
currently developing service information that will address the unsafe
condition for these airplanes. Once this service information is
developed, approved, and available, the FAA might consider additional
rulemaking.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Boeing Alert Requirements Bulletin 737-27A1312

RB, dated June 4, 2019. This service information describes procedures
for a maintenance records check to determine if any main slat track
assembly has been removed, an inspection of the main slat track
assemblies for a suspect lot number or a lot number that cannot be
determined, sending the inspection results to Boeing, and applicable
on-condition actions. On-condition actions include replacing main slat
track assemblies having a suspect lot number, or having a lot number
that cannot be determined, with serviceable main slat track assemblies;
shipping main slat track assemblies with suspect lot numbers or with
lot numbers that cannot be determined to Boeing; and contacting Boeing
to report if any main slat track assembly has been removed. 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

    The FAA is issuing this AD because the agency evaluated all the
relevant information and determined the unsafe condition described
previously is likely to exist or develop in other products of the same
type design.

AD Requirements

    This AD requires accomplishment of the actions identified in Boeing
Alert Requirements Bulletin 737-27A1312 RB, dated June 4, 2019,
described previously, except for any differences identified as
exceptions in the regulatory text of this AD.
    For information on the procedures and compliance times, see this
service information at http://www.regulations.gov by searching for and
locating Docket No. FAA-2019-0409.

FAA's Justification and Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies waiving notice and comment prior to adoption of this rule
because main slat track assemblies that are affected by hydrogen
embrittlement have reduced strength. This condition, if not addressed,
could result in failure of main slat track assemblies, which could
cause the slat to depart and potentially strike the airplane, resulting
in injury to airplane occupants and/or preventing continued safe flight
and landing. The compliance time for the required action that has been
determined to adequately address the unsafe condition is shorter than
the time necessary for the public to comment and for publication of the
final rule. Therefore, the FAA finds good cause that notice and
opportunity for prior public comment are impracticable. In addition,
for the reasons stated above, the FAA finds that good cause exists for
making this amendment effective in less than 30 days.

Regulatory Flexibility Act (RFA)

    The requirements of the RFA do not apply when an agency finds good
cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and
comment. Because the FAA has determined that it has good cause to adopt
this rule without notice and comment, RFA analysis is not required.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. However, the FAA invites you to send any written data, views,
or arguments about this final rule. Send your comments to an address
listed under the ADDRESSES section. Include the docket number FAA-2019-
0409 and Product Identifier 2019-NM-092-AD at the beginning of your
comments. The FAA specifically invites comments on the overall
regulatory, economic, environmental, and energy aspects of this final
rule. The FAA will consider all comments received by the closing date
and may amend this final rule because of those comments.
    The FAA will post all comments the agency receives, without change,
to http://www.regulations.gov, including any personal information you
provide. The FAA will also post a report summarizing each substantive
verbal contact the agency receives about this final rule.

Costs of Compliance

    The FAA estimates that this AD affects 32 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Maintenance records check.............  1 work-hour x $85 per                 $0             $85          $2,720
                                         hour = $85.
Inspection............................  3 work-hours x $85 per                 0             255           8,160
                                         hour = $255.
Reporting.............................  1 work-hour x $85 per                  0              85           2,720
                                         hour = $85.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary on-
condition actions that would be required based on the results of the
inspection. The FAA has no way of determining the number of aircraft
that might need these on-condition actions:

                                      Estimated Costs of On-Condition Costs
----------------------------------------------------------------------------------------------------------------
               Action                      Labor cost                Parts cost             Cost per product
----------------------------------------------------------------------------------------------------------------
Replacement and shipping...........  Up to 54 work-hours x   Up to $82,680............  Up to $87,270.
                                      $85 per hour = Up to
                                      $4,590.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this 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 available
known costs in our cost estimate.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this AD is 2120-
0056. The paperwork cost associated with this AD has been detailed in
the Costs of Compliance section of this document and includes time for
reviewing instructions, as well as completing and reviewing the
collection of information. Therefore, all reporting associated with
this AD is mandatory. Comments concerning the accuracy of this burden
and suggestions for reducing the burden should be directed to the FAA
at 800 Independence Ave. SW, Washington, DC 20591. ATTN: Information
Collection Clearance Officer, AES-200.

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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes and
associated appliances to the Director of the System Oversight Division.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2019-11-03 The Boeing Company: Amendment 39-19649; Docket No. FAA-
2019-0409; Product Identifier 2019-NM-092-AD.

(a) Effective Date

    This AD is effective June 10, 2019.

(b) Affected ADs

    None.

(c) Applicability

    (1) This AD applies to The Boeing Company Model 737-700C, -800,
and -900ER series airplanes, certificated in any category, as
identified in Boeing Alert Requirements Bulletin 737-27A1312 RB,
dated June 4, 2019.
    (2) Installation of Supplemental Type Certificate (STC)
ST00830SE does not affect the ability to accomplish the actions
required by this AD. Therefore, for airplanes on which STC ST00830SE
is installed, a ``change in product'' alternative method of
compliance (AMOC) approval request is not necessary to comply with
the requirements of 14 CFR 39.17.

(d) Subject

    Air Transport Association (ATA) of America Code 27, Flight
Controls.

(e) Unsafe Condition

    This AD was prompted by a report that certain main slat track
assemblies were manufactured incorrectly and are affected by
hydrogen embrittlement. The FAA is issuing this AD to address main
slat track assemblies that have reduced strength due to hydrogen
embrittlement. This condition, if not addressed, could result in
failure of main slat track assemblies, which could cause the slat to
depart and potentially strike the airplane, resulting in injury to
airplane occupants and/or preventing continued safe flight and
landing.

(f) Compliance

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

(g) Required Actions

    Except as specified by paragraph (h) of this AD: At the
applicable times specified in the ``Compliance'' paragraph of Boeing
Alert Requirements Bulletin 737-27A1312 RB, dated June 4, 2019, do
all applicable actions identified in, and in accordance with, the
Accomplishment Instructions of Boeing Alert Requirements Bulletin
737-27A1312 RB, dated June 4, 2019.

    Note 1 to paragraph (g): Guidance for accomplishing the actions
required by this AD can be found in Boeing Alert Service Bulletin
737-27A1312, dated June 4, 2019, which is referred to in Boeing
Alert Requirements Bulletin 737-27A1312 RB, dated June 4, 2019.

(h) Exceptions to Service Information Specifications

    (1) For purposes of determining compliance with the requirements
of this AD: Where Boeing Alert Requirements Bulletin 737-27A1312 RB,
dated June 4, 2019, uses the phrase ``the original issue date of
Requirements Bulletin 737-27A1312 RB,'' this AD requires using ``the
effective date of this AD.''
    (2) Boeing Alert Requirements Bulletin 737-27A1312 RB, dated
June 4, 2019, specifies to report inspection results to Boeing
within a certain compliance time. For this AD, the compliance time
to report inspection results is at the applicable time specified in
paragraph (h)(2)(i) or (h)(2)(ii) of this AD.
    (i) If the inspection was done on or after the effective date of
this AD: Submit the report within 3 days after the inspection.
    (ii) If the inspection was done before the effective date of
this AD: Submit the report within 3 days after the effective date of
this AD.
    (3) Boeing Alert Requirements Bulletin 737-27A1312 RB, dated
June 4, 2019, specifies to ship affected parts to Boeing within a
certain compliance time if, during the inspection, it has been
determined that any main slat track assembly has a suspect lot
number or has a lot number that cannot be determined. For this AD,
the compliance time for shipping affected parts to Boeing is at the
applicable time specified in paragraph (h)(3)(i) or (h)(3)(ii) of
this AD.
    (i) If the inspection was done on or after the effective date of
this AD: Ship the affected part to Boeing within 30 days after
removing the affected part.
    (ii) If the inspection was done before the effective date of
this AD: Ship the affected

part to Boeing within 30 days after the effective date of this AD.
    (4) Where ``CONDITION 5'' of Boeing Alert Requirements Bulletin
737-27A1312 RB, dated June 4, 2019, uses the phrase ``suspect lot
number cannot be determined,'' or ``suspect lot number that cannot
be determined,'' this AD requires using, ``lot number cannot be
determined,'' or ``lot number that cannot be determined;''
respectively.
    (5) Where flag note (a) of Figure 5, Figure 6, Figure 7, and
Figure 8, of Boeing Alert Requirements Bulletin 737-27A1312 RB,
dated June 4, 2019, specifies ``Only required if the main slat track
assembly has a suspect lot number,'' this AD requires using, ``Only
required if the main slat track assembly has a suspect lot number or
a lot number that cannot be determined.''

(i) Paperwork Reduction Act Burden Statement

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty
for failure to comply with a collection of information subject to
the requirements of the Paperwork Reduction Act unless that
collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 1 hour per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW, Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle 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 local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (k) of this AD. Information may be
emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by The Boeing Company Organization Designation
Authorization (ODA) that has been authorized by the Manager, Seattle
ACO Branch, FAA, to make those findings. To be approved, the repair
method, modification deviation, or alteration deviation must meet
the certification basis of the airplane, and the approval must
specifically refer to this AD.

(k) Related Information

    For more information about this AD, contact Greg Rutar,
Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 2200
South 216th St., Des Moines, WA 98198; phone and fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Alert Requirements Bulletin 737-27A1312 RB, dated
June 4, 2019.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on June 5, 2019.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-12221 Filed 6-7-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 109 (Tuesday, June 7, 2016)]
[Notices]
[Pages 36532-36533]
[FR Doc No: 2016-13409]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for electronic review at the Commission in the Public
Reference Room or may be viewed on the Commission's Web site at http://www.ferc.gov using the eLibrary link. Enter the docket number,
excluding the last three digits, in the docket number field to access
the document. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.
    Prohibited:

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                   Docket No.                              File date                 Presenter or requester
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1. CP16-21-000.................................                     5-12-2016  Diana Carroll.
2. CP16-21-000.................................                     5-16-2016  Mass Mailing.\1\
3. OR13-25-001; OR13-26-001....................                     5-17-2016  FERC Staff.\2\
4. CP16-21-000.................................                     5-18-2016  Mass Mailing.\3\
5. CP16-21-000.................................                     5-18-2016  Mass Mailing.\4\
6. CP16-21-000.................................                     5-18-2016  Wildred Wollheim.
7. CP16-21-000.................................                     5-20-2016  Mary Tyler.
8. CP15-554-000................................                     5-23-2016  Jessica E. Pitkin.
9. CP15-500-000................................                     5-23-2016  Luc Novovitch.
10. CP16-21-000................................                     5-23-2016  Maria Niswonler.
11. CP16-21-000................................                     5-23-2016  John Puffer.
12. CP16-21-000................................                     5-18-2016  Mass Mailing.\5\
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    \1\ Two letters have been sent to FERC Commissioners and staff
under this docket number.
    \2\ Memorandum dated May 6, 2016 reporting communication with
Richard Powers of Venable LLP, David Berg and Rob Myrben of Airlines
of America, and Jeffrey Petrash of National Propane Gas Association.
    \3\ Two letters have been sent to FERC Commissioners and staff
under this docket number.
    \4\ Two letters have been sent to FERC Commissioners and staff
under this docket number.
    \5\ Four letters have been sent to FERC Commissioners and staff
under this docket number.

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    Exempt:

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                   Docket No.                              File date                 Presenter or requester
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1. P-1256-000..................................                     5-13-2016  FERC Staff.\6\
2. CP16-21-000.................................                     5-13-2016  Town of Knox, NY.
3. CP13-483-000; CP13-492-000..................                     5-13-2016  U.S. House Representative Sam
                                                                                Graves.
4. CP13-492-000; CP13-493-000..................                     5-13-2016  Confederated Tribes of Coos,
                                                                                Lower Umpqua & Siuslaw Indians.
5. CP16-21-000.................................                     5-18-2016  State of New Hampshire House
                                                                                Representative Jack Flanagan.
6. P-2232-522..................................                     5-20-2016  U.S. Congress.\7\
7. CP16-21-000.................................                     5-20-2016  Town of Fitzwilliam, New
                                                                                Hampshire Board of Selectmen.
8. P-13015-001.................................                     5-20-2016  U.S. House Representative William
                                                                                R. Keating.
9. CP13-483-001; CP13-492-001..................                     5-20-2016  Jackson County, Oregon Board of
                                                                                Commissioners.
10. ER15-2563-002; EL15-95-002.................                     5-23-2016  U.S. Congress.\8\
11. CP14-96-000; PF16-1-000; PF15-12-000.......                     5-23-2016  Town of Freetown, Massachusetts
                                                                                Board of Selectmen.
12. EL15-2563-002; EL15-95-002.................                     5-24-2016  State of Delaware Governor Jack
                                                                                A. Markell.
13. CP14-517-000...............................                     5-24-2016  FERC Staff.\9\
14. CP13-483-000...............................                     5-27-2016  FERC Staff.\10\
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    \6\ Email dated April 15, 2016 with Neal Suess of Loup Power
District.
    \7\ Senators Lindset Graham, Tim Scott, Richard Burr, and Thom
Tillis. House Representatives James Clyburn, Joe Wilson, Patrick
McHenry, Jeff Duncan, Trey Gowdy, Richard Hudson, Robert Pittenger,
David Rouzer, Walter B. Jones, Virginia Foxx, Mick Mulvaney, Renee
Ellmers, George Holding, Mark Meadows, Tom Rice, and Mark Walker.
    \8\ Senators Thomas R. Carper and Christopher Coons. House
Representative John Carney.
    \9\ Meeting Summary from May 18, 2016 meeting with
representatives for the Gold Pass LNG Export Project.
    \10\ Memo forwarding letter dated May 24, 2016 from U.S. Army
Corps of Engineers (COE) to Jordan Cove and letter dated May 24,
2016 from COE to the Confederated Tribes of the Coos, Lower Umpqua,
and Siuslaw Indians.

    Dated: June 1, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-13409 Filed 6-6-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 27 (Wednesday, February 9, 2022)]
[Notices]
[Pages 7444-7446]
[FR Doc No: 2022-02700]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP21-498-000]

Columbia Gas Transmission, LLC; Notice of Intent To Prepare an
Environmental Impact Statement for the Proposed Virginia
Electrification Project, Request for Comments on Environmental Issues,
and Schedule for Environmental Review

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental impact statement (EIS) that
will discuss the environmental impacts of the Virginia Electrification
Project (Project) involving construction and operation of facilities by
Columbia Gas Transmission, LLC (Columbia) in Louisa County, Virginia;
Goochland County, Virginia; and Prince George County, Virginia. The
Commission will use this EIS in its decision-making process to
determine whether the Project is in the public convenience and
necessity. The schedule for preparation of the EIS is discussed in the
Schedule for Environmental Review section of this notice.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies regarding the project. As part of the National Environmental
Policy Act (NEPA) review process, the Commission takes into account
concerns the public may have about proposals and the environmental
impacts that could result from its action whenever it considers the
issuance of a Certificate of Public Convenience and Necessity. This
gathering of public input is referred to as ``scoping.'' The main goal
of the scoping process is to focus the analysis in the environmental
document on the important environmental issues. Additional information
about the Commission's NEPA process is described below in the NEPA
Process and the EIS section of this notice.
    By this notice, the Commission requests public comments on the
scope of issues to address in the environmental document, including
comments on potential alternatives and impacts, and any relevant
information, studies, or analyses of any kind concerning impacts
affecting the quality of the human environment. To ensure that your
comments are timely and properly recorded, please submit your comments
so that the Commission receives them in Washington, DC on or before
5:00 p.m. Eastern Time on March 3, 2022. Further details on how to
submit comments are provided in the Public Participation section of
this notice.
    If you are a landowner receiving this notice, a pipeline company
representative may contact you about the acquisition of an easement to
construct, operate, and maintain the proposed facilities. The company
would seek to negotiate a mutually acceptable easement agreement. You
are not required to enter into an agreement. However, if the Commission
approves the Project, the Natural Gas Act conveys the right of eminent
domain to the company. Therefore, if you and the company do not reach
an easement agreement, the pipeline company could initiate condemnation
proceedings in court. In such instances, compensation would be
determined by a judge in accordance with state law. The Commission does
not grant, exercise, or oversee the exercise of eminent domain
authority. The courts have exclusive authority to handle eminent domain
cases; the Commission has no jurisdiction over these matters.
    Columbia provided landowners with a fact sheet prepared by the FERC
entitled ``An Interstate Natural Gas Facility On My Land? What Do I
Need To Know?'' which addresses typically asked questions, including
the use of eminent domain and how to participate in the Commission's
proceedings. This fact sheet along with other landowner topics of
interest are available for viewing on the FERC website (www.ferc.gov)
under the Natural Gas Questions or Landowner Topics link.

Public Participation

    There are three methods you can use to submit your comments to the
Commission. The Commission encourages electronic filing of comments and
has staff available to assist you at<PHONE_NUMBER> or
[email protected]. Please carefully follow these instructions
so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature, which is located on the Commission's website (www.ferc.gov)
under the link to FERC Online. Using eComment is an easy method for
submitting brief, text-only comments on a project;
    (2) You can file your comments electronically by using the eFiling
feature, which is located on the Commission's website (www.ferc.gov)
under the link to FERC Online. With eFiling, you can provide comments
in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on ``eRegister.'' You will be asked to select the type of filing you
are making; a comment on a particular project is considered a ``Comment
on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the Commission. Be sure to reference the project docket number (CP21-
498-000) on your letter. Submissions sent via the U.S. Postal Service
must be addressed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC
20426. Submissions sent via any other carrier must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Additionally, the Commission offers a free service called
eSubscription. This service provides automatic notification of filings
made to subscribed dockets, document summaries, and direct links to the
documents. Go to https://www.ferc.gov/ferc-online/overview to register
for eSubscription.

Summary of the Proposed Project, the Project Purpose and Need, and
Expected Impacts

    Columbia proposes modifications and a certificated horsepower
increase to Columbia's existing Boswells Tavern Compressor Station and
expansion of the existing Boswells Tavern point of receipt in Louisa
County, Virginia; modifications and a certificated horsepower increase
to Columbia's existing Goochland Compressor Station in Goochland
County, Virginia; and a certificated horsepower increase at Columbia's
existing Petersburg Compressor Station in Prince George County,
Virginia. The Project would provide about 35,000 dekatherms per day of
incremental mainline capacity on Columbia's pipeline system. According
to Columbia, its Project would address a request from Columbia Gas of
Virginia, an unaffiliated local distribution

company, for firm transportation service to meet growing energy demand
in the southeast Virginia market area off of Columbia's existing VM-
107, VM-108, and VM-109 pipelines. Columbia states the Project would
reduce greenhouse gas emissions on Columbia's pipeline system through
the modification and optimization of existing infrastructure.
    The Project would consist of the following facilities all located
in Virginia:
     Installation of one zero emission electric motor
compressor unit at the Boswell Tavern Compressor Station located in
Louisa County;
     facility modifications to the Boswells Tavern point of
receipt located in Louisa County to increase capacity;
     replacement of all five existing gas-powered compressor
units at the Goochland Compressor Station, located in Goochland County,
with new units that will run exclusively on electric motors, but will
have the ability to run on gas in order to ensure reliability; and
     status change of an existing compressor unit from backup
mode to active mode and increase the site-rated station horsepower to
5,500 horsepower at the Petersburg Compressor Station located in Prince
George County.
    The general location of the Project facilities is shown in appendix
1.\1\
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    \1\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of the appendices were sent to all
those receiving this notice in the mail and are available at
www.ferc.gov using the link called ``eLibrary''. For instructions on
connecting to eLibrary, refer to the last page of this notice. At
this time, the Commission has suspended access to the Commission's
Public Reference Room due to the proclamation declaring a National
Emergency concerning the Novel Coronavirus Disease (COVID-19),
issued by the President on March 13, 2020. For assistance, contact
FERC at [email protected] or call toll free,<PHONE_NUMBER>
or TTY<PHONE_NUMBER>.
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    Based on the environmental information provided by Columbia, the
proposed Project would result in new temporary and permanent impacts at
the Boswells Tavern and Goochland Compressor Station sites. Work
associated with the Boswells Tavern point of receipt would occur within
the temporary and permanent workspaces used for the Boswells Tavern
Compressor Station. No workspace would be required at the Petersburg
Compressor Station, as no construction or ground-disturbing activities
are proposed at this site. A total of 15.8 acres would be temporarily
disturbed for construction activities. Following construction, Columbia
would retain a total of 5.8 acres of land for operations, of which 1.3
acres will be new permanent easement. All land affected by the Project
is either currently owned or leased by Columbia.

The NEPA Process and the EIS

    The EIS issued by the Commission will discuss impacts that could
occur as a result of the construction and operation of the proposed
Project under the relevant general resource areas:
     Geology and soils;
     water resources and wetlands;
     vegetation and wildlife;
     threatened and endangered species;
     cultural resources;
     land use;
     socioeconomics and environmental justice;
     air quality and noise;
     climate change; and
     reliability and safety.
    Commission staff will also make recommendations on how to lessen or
avoid impacts on the various resource areas. Your comments will help
Commission staff focus its analysis on the issues that may have a
significant effect on the human environment.
    The EIS will present Commission staff's independent analysis of the
issues. Staff will prepare a draft EIS which will be issued for public
comment. Commission staff will consider all timely comments received
during the comment period on the draft EIS and revise the document, as
necessary, before issuing a final EIS. Any draft and final EIS will be
available in electronic format in the public record through eLibrary
\2\ and the Commission's natural gas environmental documents web page
(https://www.ferc.gov/industries-data/natural-gas/environment/environmental-documents). If eSubscribed, you will receive instant
email notification when the environmental document is issued.
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    \2\ For instructions on connecting to eLibrary, refer to the
last page of this notice.
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Alternatives Under Consideration

    The EIS will evaluate reasonable alternatives that are technically
and economically feasible and meet the purpose and need for the
proposed action.\3\ Alternatives currently under consideration include:
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    \3\ 40 CFR 1508.1(z).
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     The no-action alternative, meaning the Project is not
implemented;
     the systems alternative, which would consist of pipeline
looping or an alternative configuration of the compressor stations.
    With this notice, the Commission requests specific comments
regarding any additional potential alternatives to the proposed action
or segments of the proposed action. Please focus your comments on
reasonable alternatives (including alternative facility sites and
pipeline routes) that meet the Project objectives, are technically and
economically feasible, and avoid or lessen environmental impact.

Consultation Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, the Commission is using this notice to initiate
consultation with the applicable State Historic Preservation Office(s),
and other government agencies, interested Indian tribes, and the public
to solicit their views and concerns regarding the Project's potential
effects on historic properties.\4\ The Project EIS will document
findings on the impacts on historic properties and summarize the status
of consultations under section 106.
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    \4\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
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Schedule for Environmental Review

    On October 5, 2021 the Commission issued its Notice of Application
for the Project. Among other things, that notice alerted other agencies
issuing federal authorizations of the requirement to complete all
necessary reviews and to reach a final decision on the request for a
federal authorization within 90 days of the date of issuance of the
Commission staff's final EIS for the Project. This notice identifies
the Commission staff's planned schedule for completion of the final EIS
for the Project, which is based on an issuance of the draft EIS in
August 2022

Issuance of Notice of Availability of the final EIS: December 16, 2022
90-day Federal Authorization Decision Deadline: \5\ March 16, 2023
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    \5\ The Commission's deadline applies to the decisions of other
federal agencies, and state agencies acting under federally
delegated authority, that are responsible for federal
authorizations, permits, and other approvals necessary for proposed
projects under the Natural Gas Act. Per 18 CFR 157.22(a), the
Commission's deadline for other agency's decisions applies unless a
schedule is otherwise established by federal law.
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    If a schedule change becomes necessary for the final EIS, an
additional notice will be provided so that the relevant agencies are
kept informed of the Project's progress.

Permits and Authorizations

    The table below lists the anticipated permits and authorizations
for the Project required under federal law. This

list may not be all-inclusive and does not preclude any permit or
authorization if it is not listed here. Agencies with jurisdiction by
law and/or special expertise may formally cooperate in the preparation
of the Commission's EIS and may adopt the EIS to satisfy its NEPA
responsibilities related to this Project. Agencies that would like to
request cooperating agency status should follow the instructions for
filing comments provided under the Public Participation section of this
notice.

------------------------------------------------------------------------
                 Agency                               Permit
------------------------------------------------------------------------
Federal Energy Regulatory Commission...  Certificate of Public
                                          Convenience and Necessity
                                          under Section 7(c) of the
                                          Natural Gas Act.
U.S. Fish and Wildlife Service,          Consultation under Section 7 of
 Virginia Ecological Field Services       the Endangered Species Act,
 Office.                                  the Migratory Bird Treaty Act,
                                          and the Bald and Gold Eagle
                                          Protection Act.
Virginia Department of Environmental     Minor New Source Review (NSR)
 Quality--Air Division.                   Permit Modifications for
                                          Compressor Stations.
Virginia Department of Environmental     Virginia Water Protection
 Quality--Water Division.                 Permit.
Virginia Department of Environmental     Water Quality Certification
 Quality--Water Division.                 under Section 401 of the Clean
                                          Water Act.
Virginia Department of Environmental     Consistency Determination under
 Quality--Coastal Zone Management         the Virginia Coastal Zone
 Program.                                 Management Program.
Virginia Department of Historical        Consultation under Section 106
 Resources.                               of the National Historic
                                          Preservation Act.
------------------------------------------------------------------------

Environmental Mailing List

    This notice is being sent to the Commission's current environmental
mailing list for the Project which includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for Project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on the Project and includes a mailing address with their
comments. Commission staff will update the environmental mailing list
as the analysis proceeds to ensure that Commission notices related to
this environmental review are sent to all individuals, organizations,
and government entities interested in and/or potentially affected by
the proposed Project. State and local government representatives should
notify their constituents of this proposed project and encourage them
to comment on their areas of concern.
    If you need to make changes to your name/address, or if you would
like to remove your name from the mailing list, please complete one of
the following steps:
    (1) Send an email to [email protected] stating your
request. You must include the docket number CP21-498-000 in your
request. If you are requesting a change to your address, please be sure
to include your name and the correct address. If you are requesting to
delete your address from the mailing list, please include your name and
address as it appeared on this notice. This email address is unable to
accept comments.
    OR
    (2) Return the attached ``Mailing List Update Form'' (appendix 2).

Additional Information

    Additional information about the Project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website at www.ferc.gov using the eLibrary link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number
in the ``Docket Number'' field, excluding the last three digits (i.e.,
CP21-498). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
[email protected] or<PHONE_NUMBER>, or for TTY, contact (202)
502-8659. The eLibrary link also provides access to the texts of all
formal documents issued by the Commission, such as orders, notices, and
rulemakings.
    Public sessions or site visits will be posted on the Commission's
calendar located at https://www.ferc.gov/news-events/events along with
other related information.

    Dated: February 3, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-02700 Filed 2-8-22; 8:45 am]
BILLING CODE 6717-01-P


                     INFORMATION COLLECTION REQUEST (ICR)
                      Part A of the Supporting Statement
				              (June 2016)
1.	IDENTIFICATION OF THE INFORMATION COLLECTION

	1(a)	Title:	Registration of Fuels and Fuel Additives - Health-Effects
                  Research Requirements for Manufacturers (40 CFR 79 - Subpart F) (Renewal)
			EPA ICR Number 1696.09, OMB Control Number 2060-0297
			Docket ID Number EPA-HQ-OAR-2006-0525
	1(b)	Abstract

	In accordance with the regulations at 40 CFR 79, Subparts A, B, C, D and F (there is no Subpart E), Registration of Fuels and Fuel Additives, manufacturers (includes importers) of (1) motor vehicle gasoline, (2) motor vehicle diesel fuel, and (3) additives for those fuels, are required to have their products registered by the Environmental Protection Agency (EPA) prior to their introduction into commerce.  Registration involves providing (1) a chemical description of the fuel or additive, (2) certain technical and marketing information, and (3) certain health-effects information.  Periodic reports on production and related information are required.  Subpart F requires the conduct of health-effects research.  This ICR addresses the information collection requirements of that research.  The information collection requirements of Subparts A through D, and the supplemental notification requirement of Subpart F (indicating how the manufacturer plans to satisfy the research requirements, or qualifies for an exemption) are covered by a separate ICR (EPA ICR Number 309.14, OMB Control Number 2060-0150, expiration date: 10-31-2016).

	The program is operated by the Compliance Division, Office of Transportation and Air Quality, Office of Air and Radiation.  The information developed by the health-effects research will be used to identify products with evaporative or exhaust emissions that may pose a particular threat to public health, thus meriting further investigation and/or regulation.  Manufacturers of similar products are allowed to group in order to share the research costs.  Several groups, also known as consortiums, have been formed.  The largest consortium, organized by the American Petroleum Institute (API), represents most of the manufacturers of conventional gasolines, diesel fuels, and additives.  The regulations define the fuel/additive categories for which the research is required.  There are three tiers of requirements.  Tier 1 requires an emissions characterization (combustion, and in certain instances, evaporative) and a literature search over the past 30 years for health-effects information on those emissions.  Tier 2 (also known as standard Tier 2) requires short-term inhalation exposures of laboratory animals to emissions (combustion, and if required under Tier 1, evaporative) to screen for adverse health effects.  The EPA has the authority to require "Alternative Tier 2" testing if there is a reasonable basis to conclude that such testing is more appropriate.  The EPA reached that conclusion with respect to gasoline and gasoline-oxygenate blends.  The API consortium was notified of the proposed alternative requirements in 1997.  After public review and comment, and discussions with API, the alternative requirements were finalized and API notified in 1998.  Similar situations existed for a manganese gasoline additive known a MMT, manufactured by the Ethyl Corporation (now Afton Chemical Corporation), and a blend of diesel fuel and water, known as PuriNOx, manufactured by the Lubrizol Corporation.  Tier 3 provides for follow-up research.  Tier 3 can be required when uncertainties as to the significance of observed health effects, welfare effects, and/or emissions exposures from a fuel or fuel/additive mixture interfere with EPA's ability to make reasonable estimates of the potential risks posed by the emissions from such products.

	There are approximately 600 fuel manufacturers, 1,250 additive manufacturers, 875 registered fuels, and 8,400 registered additives.  These numbers change daily.

2.	NEED FOR AND USE OF THE COLLECTION

	2(a)	Need/Authority for the Collection

	Motor vehicles comprise a major source of air pollution in urban areas, and account for about half the toxic air emissions in the United States.  Congress demonstrated its strong concern for the protection of public health by providing broad legislative authority to monitor and regulate fuels, fuel additives, and their emissions.  This registration program was established by the Air Quality Act of 1967, carried forward into the Clean Air Act (Act) of 1970, and strengthened in the Act's 1977 and 1990 reauthorizations.

	Section 211(a) of the Act provides EPA with the authority to designate, by regulation, any mobile source fuel or additive for registration.  Any fuel or additive used to such an extent that there is, or would be, significant public emissions exposure, is an appropriate candidate.  Once designated, it may not be introduced into commerce until it has been registered by EPA.  Section 211(b) requires, for the purpose of registration, that the manufacturer provide certain compositional and related information.  It provides EPA with the authority to require health-effects testing and the submittal of health-effects data and related data.  Section 211(e), a 1977 amendment, made the health-effects research requirements mandatory.  The original regulations were promulgated by the Department of Health, Education, and Welfare in 1970 and transferred to the EPA shortly thereafter.  They ultimately resided at 40 CFR 79 and were revised in 1975, 1976, 1978, 1994, 1996, 1997, 1998 and 20145  Due to their broad public emissions exposure, motor vehicle gasoline and diesel fuel, and their additives, were designated.

	The regulations at 40 CFR 79, Subpart F, promulgated on May 27, 1994, require research for each of the following fuel/additive groups whose components are derived from conventional petroleum, heavy oil deposits, coal, tar sands and/or oil sands:

	(1) Gasoline

      Baseline Group - gasoline/additive elements are limited to carbon, hydrogen, oxygen, nitrogen and sulfur (for convenience, hereby referred to as CHONS), gasoline oxygen content is less than 1.5 weight percent, and the gasoline meets the American Society for Testing and Materials (ASTM) specifications.

      Nonbaseline Group - gasoline/additive elements are limited to CHONS, gasoline oxygen content is 1.5 weight percent or greater, and the gasoline meets ASTM specifications.  A group is established for each oxygenate (e.g., ethanol).

      Atypical Group - a group is established for each non-CHONS element (e.g., manganese), combination of non-CHONS elements, property that does not meet ASTM specification, or combination of properties that do not meet ASTM specifications.

	(2) Diesel

      Baseline Group - diesel/additive elements are limited to CHONS, the fuel oxygen content is less than 1.0 weight percent, and the fuel meets ASTM specifications.

      Nonbaseline Group - diesel/additive elements are limited to CHONS, the fuel oxygen content is 1.0 weight percent or greater, and the fuel meets ASTM specifications.  A group is established for each oxygenate or specified oxygenate combinations.

      Atypical Group - a group is established for each non-CHONS element (e.g., iron), combination of non-CHONS elements, property that does not meet ASTM specification, or combination of properties that do not meet ASTM specifications.

	The regulations also establish nonbaseline groups for each gasoline, diesel fuel, and additive group that is derived in whole or in part from sources other than those mentioned above, such as shale, used oil, and waste plastics.  The fuel/additive group is defined by the source.

	The research is structured into three tiers of requirements for each group.  Tier 1 requires an emissions characterization and a literature search for the health effects of those emissions.  For products registered as of May 27, 1994, the Tier 1 data were due by May 27, 1997.  For products currently seeking registration, the Tier 1 data must be submitted before the product can be registered.  Tier 2 requires short-term inhalation exposures of laboratory animals to emissions to screen for adverse health effects.  For products registered as of May 27, 1994, the Tier 2 data were due by May 27, 1997, or evidence of a contract that would provide the Tier 2 data by May 27, 2000.  For products currently seeking registration, the Tier 2 data are due before registration can occur.   (There are several exceptions to the above.  For biodiesel products, the Tier 1 deadline was March 17, 1998, and the Tier 2 deadline was May 27, 2000.  For atypical products, the Tier 2 deadline for evidence of a contract was November 27, 1998, with the Tier 2 data due by November 27, 2001.)   The regulations also allow EPA to establish Alternative Tier 2 requirements in lieu of standard Tier 2, if warranted.  Follow-up studies, if required, would occur under Tier 3.

	The objective of the program is to determine if there are any fuels and/or additives whose evaporative emissions or products of combustion pose a particular danger to public health or welfare.  Section 211(c) of the Act provides EPA with the authority to regulate such fuels and additives.  For example, the use of lead additives in gasoline, gasoline volatility, and the sulfur content of gasoline and diesel fuel, have been regulated under this section.

	There are several exceptions to the above, in order to lessen the burden for small businesses.  Manufacturers of baseline and/or nonbaseline products, who have an annual sales revenue of less than $50 million, are exempt from Tier 1 and Tier 2.  Manufacturers of atypical products, who have an annual sales revenue of less than $10 million, are exempt from Tier 2.  There are less burdensome provisions for the manufacturers of aerosol additives.  Manufacturers who merely re-label a registered product are not subject to Tier 1, Tier 2 and Tier 3.

	In 1994 the API formed a consortium of the major fuel and additive manufacturers.  In 1997 it submitted Tier 1 data for baseline gasoline, baseline diesel, and six nonbaseline gasoline groups (di-isopropyl ether (DIPE), ethanol, ethyl tertiary butyl ether (ETBE), methyl tertiary butyl ether (MTBE), tertiary amyl methyl ether (TAME), and tertiary butyl alcohol (TBA)).  Tier 2 data were submitted for baseline diesel.   In 1997 a consortium submitted information for aerosol additive manufacturers.  In 1997 Tier 1 data were submitted for two atypical gasoline groups and five atypical diesel groups.  In 1998 and 2000, Tier 1 and Tier 2 data were submitted for biodiesel, respectively.  In 2000 and 2002, Tier 1 and Tier 2 data were submitted for summer PuriNOx, an emulsion of water and diesel.  In 2003 Tier 1 data were submitted for Clean Fuels Technology Emulsified Diesel Fuel.  In 2005 Tier 1 data were submitted for an iron-based diesel additive known as CleanBoost.  In 2006 Tier 1 data were submitted for the cerium-based diesel additive Envirox, a mixture of ethanol and diesel fuel known as O2Diesel, and the diesel additive Green Plus 850.  In 2007 Tier 1 data were submitted for Renewable Diesel Mixtures, Green Plus 851, and a mixture of ethanol, diesel and biodiesel.  In 2008 Tier 1 data were submitted for NExBTL Renewable Diesel and Nextfuels, Inc. biodiesel.  In 2009 Tier 1 data were submitted for two renewable diesels.  In 2011-2015 Tier 1 data were submitted for 15% ethanol in gasoline, 16% isobutanol in gasoline, seven diesel fuels with renewable content, and eight gasolines with renewable content.

	On August 20, 1997 the API was informed of proposed Alternative Tier 2 requirements for baseline gasoline and the six nonbaseline gasoline groups for which Tier 1 data were submitted.  After public notice and comment, and discussions with API, the alternative requirements were finalized, and API was notified on November 2, 1998.  Notice was published in the Federal Register.  The research has been completed, with the exception of some of the TBA testing, which API decided not to complete, and some protocols for DIPE and ETBE that have yet to be established.

	In 1994 the Ethyl Corporation (Ethyl) was informed that Alternative Tier 2 testing would be required for its manganese additive MMT and alternative requirements were proposed in a January 25, 1999 letter to Ethyl and announced in the Federal Register.  These requirements were finalized in a May 11, 2000 letter to Ethyl and announced in the Federal Register.  The research has been completed.

	Alternative Tier 2 requirements were also established for winter PuriNOx.  The procedure as described above was followed and the data were submitted in 2003.

	2(b)	Practical Utility/Users of the Data

	These health-effects data will allow decision makers to assess the relative risks of the fuel/additive groups described above.  Should areas of concern be identified for certain products, further investigation or regulatory action could be taken.

	The data may also be used by non-EPA organizations, such as fuel/additive producers and trade organizations, to review a product's potential toxicity, exposure, or registration status, to determine whether the submittal of further information would be duplicative, or to contact producers to use the registration already granted and share in the cost of previous compliance.  Public interest and environmental organizations may review the data and perform their own evaluations.  Laboratories may review the test reports for guidance on sound laboratory practices and data generation.  Academic and medical experts may use the information in research or to compare with independent findings.  State and local agencies responsible for protecting the public health may find these data to be of interest.  The California Environmental Protection Agency assessed the use of oxygenates in gasoline, not only from an emissions standpoint, but also from a groundwater contamination standpoint, due to leaking storage tanks.

3.	NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

	3(a)	Non-duplication

	To our knowledge, this is the only program which requires the manufacturers of motor vehicle fuels and fuel additives to develop emissions health-effects data.  The regulations allow manufacturers of similar products to group and test one representative of the group, thus minimizing duplicative testing.

	3(b)	Public Notice

	A Federal Register notice requesting public comment on this ICR was published on April 14, 2016 (81 FR 22080).  No comments were received.

	3(c)	Consultations

	Burden estimates were discussed with Lesa Rice-Jackson, Ph.D/Shell Chemical Company/(713) 241-0142. Ms. Rice-Jackson thought the costs would be in the $1.5  -  2 million range. This estimate is in line with EPA's estimate of respondent costs described in section 6 (e) Bottom Line Burden Hours and Cost Tables.

	3(d)	Effects of Less Frequent Collection

	These are one-time requirements for each product.

	3(e)	General Guidelines

	All Office of Management and Budget (OMB) guidelines are met.

	3(f)	Confidentiality

	  Section 211(b)(2)(B) of the Act requires that the results of the Tier 2 health-effects testing shall not be considered confidential.  Some Tier 1 data, particularly those related to composition, could be claimed as confidential and would be subject to EPA's freedom of information provisions at 40 CFR 2.

	3(g)	Sensitive Questions

	There are no sensitive questions.

4.	THE RESPONDENTS AND THE INFORMATION COLLECTED

	4(a)	Respondents/NAICS/SIC Codes

	The fuel and fuel additive manufacturers are related to the following major group North American Industry Classification System (NAICS) six-digit codes and Standard Industrialization Classification (SIC) four-digit codes:

324110 - Petroleum Refineries

	2911 - Diesel Fuels Manufacturing

	2911 - Gasoline Made in Petroleum Refineries

324119 - All Other Petroleum and Coal Products Manufacturing

	2999 - Oil-based Additives Made From Refined Petroleum

325110 - Petrochemical Manufacturing

	2865 - Benzene, Olefins, Toluene, and Xylene

	2869 -Butane
325193 - Ethyl Alcohol Manufacturing

	2869 - Ethanol

	4(b)	Information Requested

	(i)	Data Items

	The following is required to be submitted for each fuel and additive subject to the Tier 1 requirements (40 CFR 79.52):

1. 	Name of the manufacturer and name of the fuel or additive;
2. 	Group/consortium identification;
3. 	Literature search over the past 30 years for existing information pertaining to health 	effects, environmental effects, and emissions of the fuel or additive; includes description 	of data bases searched, search period, and summary of relevant information found, 	including abstracts and references;
4.	Chemical characterization of combustion and evaporative emission products; report on 	emissions generation procedures, analytic methods, and results.  This requirement can be 	mitigated by adequate existing information obtained during the literature search in item 3.  	The full report(s) summarized in item 3 would be required.

	The following is required to be submitted for each fuel and additive subject to the Tier 2 or  Alternative Tier 2  requirements (40 CFR 79.53):

1.	Name of the manufacturer and name of the fuel or additive;
2.	Group/consortium identification;
3.	Results of subchronic, 90-day, inhalation exposure of lab animals to combustion emissions, and in separate testing, if applicable, to evaporative emissions, for screening of general toxicity, carcinogenicity, mutagenicity, adult reproduction/teratogenicity, pulmonary toxicity, and neurotoxicity for Tier 2, or related negotiated testing for Alternative Tier 2.  This requirement can be mitigated by adequate existing information obtained during the literature search of Tier 1.  The full report(s) summarized in Tier 1 would be required.

	The following is required to be submitted for each fuel and additive subject to the Tier 3 requirements (40 CFR 79.54):

1. 	Name of the manufacturer and name of the fuel or additive;
2.	Group/consortium identification;
3.	Results of follow-up testing to resolve uncertainties identified upon analysis of Tier 1 and/or Tier 2/Alternative Tier 2 data.  The test requirements will be established through notice and comment and negotiation with the manufacturer(s).  The burden will likely be comparable to that for Tier 2 testing.

	See 40 CFR 79.59(c) for the detailed documentation requirements of the Tier 1, Tier 2, and Alternative Tier 2 reports.  See 40 CFR 79.59(d) for the detailed documentation requirements for a Tier 3 report.  There are no recordkeeping requirements.

	(ii)	Respondent Activities

	The following activities are required:

1.	Read or hear the regulations at 40 CFR 79, Subpart F;
2.	Obtain the required data;
3.	Review the data;
4.	Prepare the required report(s);
5.	Send the report(s) to EPA.

5.	THE INFORMATION COLLECTED--AGENCY ACTIVITIES, COLLECTION 	METHODOLOGY, AND INFORMATION MANAGEMENT

	5(a)	Agency Activities

	The following activities are required:

1.	Respond to inquiries on the Tier 1, Tier 2, Alternative Tier 2, and Tier 3 requirements;
2.	Provide copies of the regulations;
3.	Review the Tier 1, Tier 2, Alternative Tier 2, and Tier 3 reports;
4.	Upon completion of a review, notify the submitter that the report is adequate, or, if it is 	inadequate, notify the submitter of the deficiencies;
5.	Establish public access to the test results, as required by the Act, while maintaining the 	confidentiality of data so entitled;
6.	Store the reports.

	5(b)	Collection Methodology and Management

	The reports will be reviewed by the Office of Transportation and Air Quality and the Office of Research and Development.  The quality of the data will be determined by professionals knowledgeable with emissions and health-effects testing.  The review will be manual.  The nature of the reports makes them unsuitable for automatic data processing.  The reports will be available to the public in hard copy, and, if so submitted, electronically.  They will be stored in the format submitted.

      5(c)	Small Entity Flexibility

	As discussed in section 2(a), certain small businesses are exempt from some or all of these requirements.

	5(d)	Collection Schedule

	There is no schedule.  The requirements apply when a manufacturer applies for registration.

6.	ESTIMATING THE BURDEN AND THE COST OF THE COLLECTION

	6(a) and (b)	Estimating Respondent Burden and Costs

	It is likely that only limited additional Tier 1 research will be done.  Future fuels and additives subject to Tier 1 will almost exclusively be those that can group with existing Tier 1 data, and likely will come from manufacturers who have already paid for the Tier 1 data.  Thus, it is estimated that there will only be one Tier 1 submission per year over the next three years.  However, manufacturers of baseline and nonbaseline products with less than $50 million in annual revenue are exempt from Tier 1, so there may be continuing registration activity in that area.

	In the previous ICR it was concluded that the few new products for which a new Tier 1 would be required are likely to be in the atypical or nonbaseline category, with an estimated Tier 1 cost of about $392,000 per product, with about $126,000 for the literature search and about $266,000 for the emissions characterization.  Estimates from two recent submissions are similar: $360,000 and $390,000 in total costs.  However, the estimated literature search cost decreased to around $65,000 while the estimated emissions characterization cost increased to around $325,000.  We believe that experience in the conduct of these literature searches combined with improved efficiencies in internet search techniques account for the reduced cost of the literature search. We have adjusted the estimated burden hours accordingly. We believe that the increased cost for the emissions characterization is due to increased start-up costs and increased operating and maintenance costs due to more complex engines.  Thus, those estimated burden hours remain the same.  There is also a slight adjustment in cost due to updated labor rates.

	The new estimate of $393,000 was determined as follows:

	In discussions with fewer than ten fuel and fuel additive manufacturers, four labor categories were identified as having involvement: managerial, legal, professional/technical (prof/tech), and clerical.  According to the Bureau of Labor Statistics, May 2014 National  Occupational Employment and Wage Estimates, mean wages were:

Managerial      $62.80 per hour
Legal		$64.17 per hour
Prof/Tech	$46.32 per hour
Clerical	$17.08 per hour

	Doubling for company overhead and employing a 2% annual inflation factor to bring the rates to 2016, and, for convenience, rounding up to the even dollar, gives the following rates that will be used in this ICR:

Total Employer Cost

Managerial 	$130 per hour
Legal		$134 per hour
Prof/Tech	$ 96 per hour
Clerical 	$ 36 per hour

	This is similar to the previous ICR.  Our estimates are:

Worksheet 1: Tier 1 Literature Search

	The estimated burden hours and costs are:

Activity		mgmt		legal		prof/tech	clerical

read regs		20/$2600 	20/$2680	20/$1920	20/$720

obtain data		20/$2600	20/$2680 	100/$9600	100/$3600

review data		20/$2600	20/$2680	100/$9600	100/$3600

prepare report
and send to EPA	20/$2600	20/$2680	50/$4800	50/$1800

totals			80/$10,040	80/$10,720	270/$25,920	270/$9,720	700/$56,400

	Capital/start-up costs for the literature search are estimated at $10,000 for the purchase of computer hardware/software for recording the search and the purchase of filing cabinets for storage.  Operating and maintenance costs are estimated at $2000 for computer maintenance, document storage, and shipping of the report and documents to EPA.  This research takes less than a year and thus these are annualized costs.

Worksheet 2: Tier 1 Emissions Characterization

	The estimated hours and costs are:

Activity		mgmt		legal		prof/tech	clerical

read regs		40/$5200	40/$5360	40/$3840	40/$1440

obtain data		40/$5200	40/$5360	500/$48,000	500/$18,000

review data		40/$5200	40/$5360	100/$9,600	100/$3600

prepare report
and send to EPA	40/$5200	40/$5360	100/$9,600	100/$3600

totals			160/$20,800	160/$21,440	740/$71,040	740/$26,640	1800/$139920

	Capital/start-up costs are estimated at $35,000 for the purchase of test engines and computer hardware/software.  Operating and maintenance costs are estimated at $150,000 for lease of laboratory space and test equipment.  This research takes less than a year and thus these are annualized costs.  Thus, the total estimated cost for a Tier 1 submission is $56,400 + $10,000 + $2,000 + $139,920 + $35,000 + $150,000 = $393,320.

	Standard Tier 2/Alternative Tier 2/Tier 3 activity also will be very limited.  The EPA has concluded that existing data cover Tier 2 for baseline diesel.  Alternative Tier 2 covers baseline gasoline, six nonbaseline gasoline oxygenates, and the atypical gasoline additive MMT.  Thus, only atypical products for manufacturers with $10 million or greater in annual revenue, and new nonbaseline products, in addition to DIPE and ETBE, for manufacturers with $50 million or greater in annual revenue, remain that would be subject to the standard Tier 2 or Alternative Tier 2 requirements.  While EPA has yet to require a Tier 3, it is likely to have a burden similar to that for Tier 2/Alternative Tier 2.  EPA estimates that there will be three standard Tier 2/Alternative Tier 2/Tier 3 submittals over the next three years, at an estimated annualized cost of about $1.7 million each.

Worksheet 3: Tier 2/alternative Tier 2/Tier 3 Inhalation Research

	The estimated hours and costs are:

Activity		mgmt		legal		prof/tech	clerical

read regs		160/$20800	160/$21440	160/$15360	160/$5760

obtain data		160/$20800	160/$21440	8000/$768000 4000/$144000

review data		160/$20800	160/$21440	800/$76800	800/$28800

prepare report
and send to EPA	160/$20800	160/$21440	400/$38400	400/$14400

totals			640/$83200	640/$85760	9360/$898560 5360/$192960

grand total		16000/$1,260,480

	Capital/start-up costs are estimated at $150,000 for the purchase of animals, cages/related equipment, and computer hardware/software.  Operating and maintenance costs are estimated at $250,000 for the lease of laboratory space and test equipment, and animal supplies. The research takes about a year and thus these are annualized costs. Thus, the total estimated cost for a Tier 2 submission is $1,260,480 + $150,000 + $250,000 = $1,660,480

	6(c)	Estimating Agency Burden and Cost

	It is estimated that the EPA will expend about one-half of a Full Time Equivalent (FTE) annually, allocated among several professionals, for the activities listed in section 5(a). Assuming $80 per hour, for government salary and overhead at the professional level, gives an annual cost of $83,200 to the EPA.  Costs for storage and public availability will be nominal.

	6(d) 	Estimating the Respondent Universe and Total Burden and Costs

	As discussed, it is anticipated that Tier 1 and standard Tier 2/Alternative Tier 2/Tier 3 activities will be very limited, with three Tier 1 submissions and three Tier 2/Alternative Tier 2/Tier 3 submissions over the next three years, at an estimated cost of $0.4 million for each Tier 1 and $1.7 million for each Tier 2/Alternative Tier 2/Tier 3, for an annual burden of about $2.1 million. The estimated annual EPA burden is $83,200.

	6(e)	 Bottom Line Burden Hours and Cost Table

Worksheet 4: Annual Industry Burden

Activity	Number	Capital/Start-up	O&M costs	Total Hours	Total Cost

Tier 1		1		$45,000		$152,000	1,600		$393,320

Tier 2/		1		$150,000		$250,000	16,000		$1,660,480
Alt. 2/T3

Totals		2		$195,000		$402,000	17,600		$2,053,800

	6(f) 	Reasons for Change in Burden

	There is a decrease 1,600 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This decrease is due to a revision in the estimate for conducting the Tier 1 literature search. Based on respondent comments, we revised the estimates for the Tier 1 requirements and updated the labor rates.  Only the labor rates were adjusted for Tier 2.

Worksheet 5: Change in Burden - Annual Responses/Annual Hours

Previous	Requested	Change	Reason

2/19,200	2/17,600	0/-1,600	Adjustment (see paragraph 6(f))

	6(g)	Burden Statements

		Burden Statement:  The annual public reporting and recordkeeping burden for this collection of information is estimated to average 8,800 hours per response.  Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency.  This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; 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.
	To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. EPA- HQ-OAR-2006-0525, which is available for public viewing at the Office of Air and Radiation Docket in the EPA Docket Center (EPA/DC), WJC West, Room 3334, 1301 Constitution Ave., NW, Washington, DC.  The EPA Docket Center Public Reading Room  is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.  The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for the  Office of Air and Radiation Docket is<PHONE_NUMBER>).  An electronic version of the public docket is available through www.regulations.gov.  Use this site to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically.  Once in the system, select "search," then key in the docket ID number identified above.  Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA.  Please include the EPA Docket ID No. (EPA-HQ-OAR-2006-0525 ) and OMB control number (2060-0297) in any correspondence.

Part B of the Supporting Statement - Not Applicable to this ICR


[Federal Register: April 23, 2008 (Volume 73, Number 79)]
[Rules and Regulations]
[Page 21819]
[DOCID:fr23ap08-5]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556

New Animal Drugs; Enrofloxacin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Bayer HealthCare LLC. The supplemental NADA
provides for use of enrofloxacin injectable solution in swine for the
treatment and control of respiratory disease.

DATES: This rule is effective April 23, 2008.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Bayer HealthCare LLC, Animal Health
Division, P.O. Box 390, Shawnee Mission, KS 66201, filed a supplement
to NADA 141-068 for BAYTRIL 100 (enrofloxacin) injectable solution. The
supplemental NADA provides for use of enrofloxacin injectable solution
in swine for the treatment and control of swine respiratory disease
(SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella
multocida, Haemophilus parasuis, and Streptococcus suis. The
supplemental NADA is approved as of March 14, 2008, and the regulations
in 21 CFR 522.812 and 556.228 (Sec. Sec.  522.812 and 556.228) are
amended to reflect the approval.
    In addition, FDA has noticed that Sec.  556.228 is not in
alphabetical sequence in 21 CFR part 556. At this time, that section is
being redesignated to correct this error. A conforming change is also
being made in Sec.  522.812 to reflect the correction in part 556.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness
data and information submitted to support approval of this application
may be seen in the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval
qualifies for 3 years of marketing exclusivity beginning on the date of
approval. The agency has determined under 21 CFR 25.33(d)(5) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 522

    Animal drugs.

21 CFR Part 556

    Animal drugs, Food.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 522 and
556 are amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
2. Section 522.812, is amended by revising paragraph (c) and adding
paragraph (e)(3) to read as follows:

Sec.  522.812  Enrofloxacin.

* * * * *
    (c) Related tolerance. See Sec.  556.226 of this chapter
* * * * *
    (e) * * *
    (3) Swine. Use the product described in paragraph (a)(2) of this
section as follows:
    (i) Amount. Administer 7.5 mg/kg of body weight once, by
subcutaneous injection behind the ear.
    (ii) Indications for use. For the treatment and control of swine
respiratory disease (SRD) associated with Actinobacillus
pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and
Streptococcus suis.
    (iii) Limitations. Animals intended for human consumption must not
be slaughtered within 5 days of receiving a single-injection dose.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
3. The authority citation for 21 CFR part 556 continues to read as
follows:

    Authority: 21 U.S.C. 342, 360b, 371.

Sec.  556.228  [Redesignated as Sec.  556.226]

0
4. Redesignate Sec.  556.228 as Sec.  556.226 and revise newly
redesignated Sec.  556.226 to read as follows:

Sec.  556.226  Enrofloxacin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of
enrofloxacin is 3 micrograms per kilogram of body weight per day.
    (b) Tolerances. The tolerances for enrofloxacin are:
    (1) Cattle--(i) Liver (target tissue). 0.1 part per million (ppm)
desethylene ciprofloxacin (the marker residue).
    (ii) [Reserved]
    (2) Swine--(i) Liver (target tissue). 0.5 ppm enrofloxacin (the
marker residue).
    (ii) [Reserved]
    (c) Related conditions of use. See Sec.  522.812 of this chapter.

    Dated: April 11, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-8713 Filed 4-22-08; 8:45 am]

BILLING CODE 4160-01-S