[Federal Register Volume 77, Number 209 (Monday, October 29, 2012)]
[Proposed Rules]
[Pages 65503-65506]
[FR Doc No: 2012-26499]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-1148; Directorate Identifier 2012-CE-039-AD]
RIN 2120-AA64

Airworthiness Directives; Diamond Aircraft Industries GmbH
Airplanes

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

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Diamond Aircraft Industries GmbH Models DA 42, DA 42 M-NG, and DA 42 NG
airplanes. This proposed AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as
overextension of the main landing gear (MLG) shock absorber that could
lead to the MLG jamming in the gear bay and result in damage to the
aircraft or occupant injury. We are issuing this proposed AD to require
actions to address the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by December 13,
2012.

ADDRESSES: You may send comments 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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Diamond Aircraft Industries GmbH, N.A. Otto-Stra[szlig]e 5, A-2700
Wiener Neustadt, Austria, telephone: +43 2622 26700; fax: +43 2622
26780; email<EMAIL_ADDRESS>Internet: http://www.diamond-air.at. You may review copies of the referenced service information at
the FAA, Small Airplane

Directorate, 901 Locust, Kansas City, Missouri 64106. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; 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 proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Mike Kiesov, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2012-1148;
Directorate Identifier 2012-CE-039-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued AD
No.: 2012-0174, dated September 4, 2012 (referred to after this as
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    An incident was reported where a Diamond DA 42 experienced main
landing gear (MLG) extension problems during approach, with the left
hand (LH) MLG not down. An uneventful landing was made with minor
damage to the aeroplane and no injuries to occupants.
    Subsequent investigation results showed that the affected MLG
leg shock absorber, P/N D60-3277-10-00, had overextended, resulting
in the MLG being jammed in the gear bay. The overextension had been
caused by a retaining nut in the MLG shock absorber which had
loosened itself during operation.
    This condition, if not corrected, could inhibit proper extension
of the MLG, possibly resulting in damage to the aeroplane and injury
to occupants.
    Prompted by the reported event, Diamond Aircraft Industries
(DAI) published Recommended Service Bulletin (RSB) 42-089/RSB 42NG-
017 which includes Working Instruction (WI) WI-RSB-089/WI-RSB 42NG-
017 (published as a single document) to recommend operators to
modify the affected dampers to P/N D60-3277-10-00--01 standard,
which incorporates installation of a new retaining nut and a new
seal system for the MLG damper that is more durable and can
withstand a greater temperature range.
    Since that RSB was issued, further analysis has shown that the
risk of a MLG failing to extend is greater than was initially
determined. Consequently, DAI issued Mandatory Service Bulletin MSB
42-095/MSB 42NG-026 to alert aeroplane owners and operators
accordingly. The new MSB contains the same instructions as the
earlier RSB, but is no longer `at owner's discretion'.
    For the reasons described above, this AD requires modification
of the affected MLG leg shock absorber, P/N D60-3277-10-00. This AD
also prohibits installation of unmodified P/N D60-3277-10-00 MLG leg
shock absorbers.

    You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Diamond Aircraft Industries GmbH has issued the following service
information:
     Mandatory Service Bulletin MSB 42-095, MSB 42NG-026, dated
November 11, 2011;
     Recommended Service Bulletin RSB 42-089/1, RSB 42NG-017/1,
dated April 19, 2011;
     Page 202 through page 211 of CHAPTER 32 LANDING GEAR in
Diamond Aircraft DA 42 Series AMM, Doc  7.02.01, Rev. 2, dated
June 30, 2008;
     Page 201 through page 213 in Temporary Revision AMM-TR-
O[Auml]M 42-195 of Diamond Aircraft DA 42 AMM, Doc  7.02.01,
dated July 14, 2010; and
     Page 203 through page 214 of CHAPTER 32 LANDING GEAR in
Diamond Aircraft DA 42 NG AMM, Doc  7.02.15, Rev. 1, dated
October 15, 2009.
    The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of the Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Costs of Compliance

    We estimate that this proposed AD will affect 175 products of U.S.
registry. We also estimate that it would take about 2 work-hours per
product to comply with the basic requirements of this proposed AD. The
average labor rate is $85 per work-hour. Required parts would cost
about $115 per product.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $49,875, or $285 per product.
    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Diamond Aircraft Industries GmbH: Docket No. FAA-2012-1148;
Directorate Identifier 2012-CE-039-AD.

(a) Comments Due Date

    We must receive comments by December 13, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Diamond Aircraft Industries GmbH Models DA
42, DA 42 M-NG, and DA 42 NG airplanes, all serial numbers,
certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 32: Landing
Gear.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as overextension of
the main landing gear (MLG) shock absorber. We are issuing this AD
to prevent the MLG jamming in the gear bay, which could result in
damage to the aircraft or occupant injury.

(f) Actions and Compliance

    Unless already done, do the following actions:
    (1) Within the next 200 hours time-in-service (TIS) after the
effective date of this AD or within the next 12 months after the
effective date of this AD, whichever occurs first, modify the left
hand (LH) and right hand (RH) MLG leg shock absorbers part number
(P/N) D60-3277-10-00 (no P/N change necessary) following Diamond
Aircraft Industries GmbH Mandatory Service Bulletin MSB 42-095, MSB
42NG-026, dated November 11, 2011, or replace each MLG leg shock
absorber P/N D60-3277-10-00 with a modified unit P/N D60-3277-10-00-
01, following, as applicable: Diamond Aircraft Industries GmbH
Recommended Service Bulletin RSB 42-089/1, RSB 42NG-017/1, dated
April 19, 2011; page 202 through page 211 of CHAPTER 32 LANDING GEAR
in Diamond Aircraft DA 42 Series AMM, Doc  7.02.01, Rev. 2,
dated June 30, 2008; page 201 through page 213 in Temporary Revision
AMM-TR-O[Auml]M 42-195 of Diamond Aircraft DA 42 AMM, Doc
7.02.01, dated July 14, 2010; and page 203 through page 214 of
CHAPTER 32 LANDING GEAR in Diamond Aircraft DA 42 NG AMM, Doc
 7.02.15, Rev. 1, dated October 15, 2009.
    (2) Modification of an airplane following Diamond Aircraft
Industries GmbH Recommended Service Bulletin RSB 42-089/1, RSB 42NG-
017/1, dated April 19, 2011, following working instruction WI-MSB
42-095, MSB 42NG-026, dated November 11, 2011, as referenced in
Diamond Aircraft Industries GmbH Mandatory Service Bulletin MSB 42-
095, MSB 42NG-026, dated November 11, 2011, is acceptable to comply
with the requirement of paragraph (f)(1) of this AD.
    (3) After the effective date of this AD, do not install an MLG
leg shock absorber P/N D60-3277-10-00 on the airplane, unless the
shock absorber has been modified following Diamond Aircraft
Industries GmbH Mandatory Service Bulletin MSB 42-095, MSB 42NG-026,
dated November 11, 2011, or following Diamond Aircraft Industries
GmbH Recommended Service Bulletin RSB 42-089/1, RSB 42NG-017/1,
dated April 19, 2011; and following working instruction WI-MSB 42-
095, MSB 42NG-026, dated November 11, 2011, as referenced in Diamond
Aircraft Industries GmbH Mandatory Service Bulletin MSB 42-095, MSB
42NG-026, dated November 11, 2011.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Mike Kiesov, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Before using any approved AMOC on any airplane
to which the AMOC applies, notify your appropriate principal
inspector (PI) in the FAA Flight Standards District Office (FSDO),
or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, 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 5 minutes 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.

(h) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.:
2012-0174, dated September 4, 2012; Diamond Aircraft Industries GmbH
Mandatory Service Bulletin MSB 42-095, MSB 42NG-026, dated November
11, 2011; Diamond Aircraft Industries GmbH Recommended Service
Bulletin RSB 42-089/1, RSB 42NG-017/1, dated April 19, 2011; page
202 through page 211 of CHAPTER 32 LANDING GEAR in Diamond Aircraft
DA 42 Series AMM, Doc  7.02.01, Rev. 2, dated June 30,
2008; page 201 through page 213 in Temporary Revision AMM-TR-
O[Auml]M 42-195 of Diamond Aircraft DA 42 AMM, Doc
7.02.01, dated July 14, 2010; and page 203 through page 214 of
CHAPTER 32 LANDING GEAR in Diamond Aircraft DA 42 NG AMM, Doc
 7.02.15, Rev. 1, dated October 15, 2009, for related
information. For service information related to this AD, contact
Diamond Aircraft Industries GmbH, N.A. Otto-Stra[szlig]e 5, A-2700
Wiener Neustadt, Austria, telephone: +43 2622 26700; fax: +43 2622
26780; email<EMAIL_ADDRESS>Internet: http://www.diamond-air.at. You may review copies of the referenced service information
at the FAA, Small Airplane Directorate, 901 Locust, Kansas City,
Missouri 64106. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.

    Issued in Kansas City, Missouri, on October 22, 2012.
James E. Jackson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-26499 Filed 10-26-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 92 (Friday, May 12, 2023)]
[Notices]
[Pages 30765-30767]
[FR Doc No: 2023-10252]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1211]

Recommendations for Evaluating Donor Eligibility Using Individual
Risk-Based Questions To Reduce the Risk of Human Immunodeficiency Virus
Transmission by Blood and Blood Products; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Recommendations for
Evaluating Donor Eligibility Using Individual Risk-Based Questions to
Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood
and Blood Products; Guidance for Industry.'' The guidance document
provides blood establishments that collect blood or blood components,
including Source Plasma, with FDA's revised donor deferral
recommendations for individuals with increased risk for transmitting
human immunodeficiency virus (HIV) infection. FDA is also recommending
that these blood establishments make corresponding revisions to donor
educational materials, donor history questionnaires and accompanying
materials, along with revisions to donor requalification and product
management procedures. The guidance announced in this notice finalizes
the draft guidance of the same title issued January 2023. This guidance
also supersedes the guidance entitled ``Revised Recommendations for
Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood
and Blood Products; Guidance for Industry'' dated April 2020 and
updated August 2020.

DATES: The announcement of this guidance is published in the Federal
Register on May 12, 2023.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-D-1211 for ``Recommendations for Evaluating Donor Eligibility
Using Individual Risk-Based Questions to Reduce the Risk of Human
Immunodeficiency Virus Transmission by Blood and Blood Products;
Guidance for Industry.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance document
to the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in
processing your requests. The guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Andrew Harvan, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance entitled
``Recommendations for Evaluating Donor Eligibility Using Individual
Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus
Transmission by Blood and Blood Products; Guidance for Industry.'' This
guidance document provides blood establishments that collect blood or
blood components, including Source Plasma, with FDA's revised donor
deferral recommendations for individuals with increased risk for
transmitting HIV infection. FDA is also recommending that these blood
establishments make corresponding revisions to donor educational
materials, donor history questionnaires and accompanying materials,
along with revisions to donor requalification and product management
procedures.
    In this guidance, based on FDA's review of the available science,
FDA recommends eliminating the screening questions specific to men who
have sex with men (MSM) and women who have sex with MSM. Instead, FDA
recommends assessing donor eligibility using the same individual risk-
based questions relevant to HIV risk for every donor regardless of sex
or gender. In addition, FDA recommends deferral of any individual
taking medications to treat or prevent HIV infection. FDA does not
expect that implementation of these revised recommendations will be
associated with any adverse effect on the safety or availability of the
blood supply.
    In the Federal Register of January 30, 2023 (88 FR 5894), FDA
announced the availability of the draft guidance of the same title. FDA
considered comments received on this draft guidance as the guidance was
being finalized and revised the guidance as appropriate in response to
the comments. For instance, we clarified that all donors, regardless of
their sex or gender, will be asked the same screening questions with
respect to HIV risk. We have provided additional information to explain
why undetectable does not equal untransmissible for blood transfusion
regarding medication used to treat or prevent HIV infection, and we
added a recommendation that individuals should not stop taking their
prescribed medication, including PrEP or PEP, in order to donate blood.
In response to questions about deferral recommendations for anal sex,
we clarified that scientific data demonstrate the risk of HIV infection
is significantly greater for anal sex when compared to other sexual
exposures. In response to comments requesting clarification on a
screening question, we included examples of who a ``new partner'' may
include. Additionally, editorial changes were made to improve clarity.
The guidance announced in this notice finalizes the draft guidance of
the same title dated January 2023 and supersedes the guidance entitled
``Revised Recommendations for Reducing the Risk of Human
Immunodeficiency Virus Transmission by Blood and Blood Products;
Guidance for Industry'' dated April 2020 and updated August 2020.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on evaluating donor eligibility using
individual risk-based questions to reduce the risk of HIV transmission
by blood and blood products. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR 601.12 have been approved under OMB control
number 0910-0338; the collections of information in 21 CFR 606.121 and
parts 610 and 630 have been approved under OMB control number 0910-
0116; and the collections of information for consignee notification
have been approved under OMB control number 0910-0681.

III. Electronic Access

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

    Dated: May 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10252 Filed 5-11-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: January 3, 2006 (Volume 71, Number 1)]
[Notices]
[Page 107]
[DOCID:fr03ja06-68]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL06-30-000]

California Electricity Oversight Board; People of the State of
California, ex rel. Bill Lockyer, Attorney General, California
Department of Water Resources v. Calpine Energy Services, LP., Calpine
Corporation, Power Contract Financing, LLC. and Gilroy Energy Center,
LLC.; Notice of Complaint; Notice of Complaint

December 22, 2005.
    Take notice that on December 19, 2005, the California Electricity
Oversight Board, the People of the State of California and the
California Department of Water Resources (collectively, California
State Parties), filed a complaint requesting Fast Tract Processing
against Calpine Energy Services, LP., Calpine Corporation, Power
Contract Financing, LLC., and Gilroy Energy Center, LLC.,
(collectively, Calpine). Specifically, California State Parties request
the Commission to require Calpine to continue to provide service under
a certain Master Power Purchase and Sale Agreement Amended and Restated
Confirmation Letter until December 31, 2009.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

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

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

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on January 19, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-8165 Filed 12-30-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 235 (Friday, December 6, 2013)]
[Proposed Rules]
[Page 73472]
[FR Doc No: 2013-28955]

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

40 CFR Part 52

[EPA-R03-OAR-2013-0650; FRL-9903-77-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Maryland; State Boards Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to approve the State Implementation Plan (SIP)
revision submitted by the State of Maryland for the purpose of
addressing the State Boards' requirements for all criteria pollutants
of the National Ambient Air Quality Standards (NAAQS). In the Final
Rules section of this Federal Register, EPA is approving the State's
SIP submittal as a direct final rule without prior proposal because the
Agency views this as a noncontroversial submittal and anticipates no
adverse comments. A detailed rationale for the approval is set forth in
the direct final rule. If no adverse comments are received in response
to this action, no further activity is contemplated. If EPA receives
adverse comments, the direct final rule will be withdrawn and all
public comments received will be addressed in a subsequent final rule
based on this proposed rule. EPA will not institute a second comment
period. Any parties interested in commenting on this action should do
so at this time.

DATES: Comments must be received in writing by January 6, 2014.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2013-0650 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2013-0650, Cristina Fernandez, Associate
Director, Office of Air Program Planning, Air Protection Division,
Mailcode 3AP30, U.S. Environmental Protection Agency, Region III, 1650
Arch Street, Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2013-0650. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the Maryland Department of the Environment, 1800
Washington Boulevard, Suite 705, Baltimore, Maryland 21230.

FOR FURTHER INFORMATION CONTACT: Ruth Knapp,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For further information, please see the
information provided in the direct final action, with the same title,
that is located in the ``Rules and Regulations'' section of this
Federal Register publication. Please note that if EPA receives adverse
comment on an amendment, paragraph, or section of this rule and if that
provision may be severed from the remainder of the rule, EPA may adopt
as final those provisions of the rule that are not the subject of an
adverse comment.

    Dated: November 14, 2013.
W.C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2013-28955 Filed 12-5-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 122 (Monday, June 25, 2012)]
[Notices]
[Pages 37944-37945]
[FR Doc No: 2012-15380]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67216; File No. SR-ISE-2012-52]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing of Proposed Rule Change To Allow Competitive
Market Makers To Use Their Membership Points To Enter Multiple Quotes
in an Options Class

June 19, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on June 6, 2012, the International Securities Exchange, LLC (the
``Exchange'' or the ``ISE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II and III below, which items have been prepared by the self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to adopt .03 of the Supplementary Material to
Rule 802 (Appointment of Market Makers) to allow Competitive Market
Makers (``CMMs'') to use their membership points to enter multiple
quotes in an options class. The text of the proposed rule change is
available on the Exchange's Internet Web site at http://www.ise.com, at
the principal office of the Exchange, and at the Commission's Public
Reference Room.

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

    In its filing with the Commission, the 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
    On August 11, 2011, the Exchange changed the structure of CMM
appointments to give market makers flexibility to choose the options
classes to which they are appointed.\3\ On October 3, 2011, the
Exchange made three refinements to the point values assigned to certain
options classes.\4\ Currently, under this structure, the Exchange
assigns points to each options class equal to its percentage of overall
industry volume (not including exclusively-traded index options),
rounded down to the nearest hundredth of a percentage, with a maximum
of 15 points. New listings are assigned a point value of zero for the
remainder of the quarter in which it was listed. A CMM is then
permitted to seek appointments to options classes that total twenty
points for the first CMM trading right owned or leased by a member, and
ten points for each subsequent CMM trading right owned or leased by the
same member.\5\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 65100 (Aug. 11,
2011), 76 FR 51075 (Aug. 17,
     2011) (order approving SR-ISE-2011-33).
    \4\ See Securities Exchange Act Release No. 65534 (October 12,
2011), 76 FR 64417 (October
     18, 2011) (Notice of Filing and Immediate Effectiveness SR-ISE-
2011-58).
    \5\ CMMs can select the options classes to which they seek
appointment, but the Exchange
     retains the authority to make such appointments and to remove
appointments from CMMs
     based on their performance. See ISE Rule 802.
---------------------------------------------------------------------------

    The Exchange is now proposing to adopt .03 of the Supplementary
Material to Rule 802 (Appointment of Market Makers) to allow CMMs to
use their membership points to enter multiple quotes in an options
class. The quoting requirements in ISE Rules will be applicable to each
set of quotes that a CMM enters in an options class. In other words,
CMMs will not be permitted to aggregate multiple quotes in an options
class in order to meet the quoting requirements under ISE Rules.
Additionally, there will be no restriction on a CMM seeking appointment
to options classes in which it or an affiliated market-maker holds a
CMM or

Primary Market Maker appointment,\6\ provided that such Member has
sufficient CMM points for each such appointment.
---------------------------------------------------------------------------

    \6\ The Chicago Board Options Exchange (``CBOE'') has a
membership structure that allows a market maker and its affiliates
to enter multiple quotes in an options class. CBOE Rule 8.3(c)(vi)
restricts market makers from holding appointments in the same class
as an affiliate if CBOE uses in that class an allocation algorithm
that allocates electronic trades, in whole or in part, in an equal
percentage based on the number of market participants quoting at the
best bid or offer. The CBOE rule then provides that this restriction
does not apply if CBOE uses in a particular options class an
allocation algorithm that does not allocate electronic trades, in
whole or in part, in an equal percentage based on the number of
market participants quoting at the best bid or offer. Unlike the
CBOE, the ISE allocation algorithm does not provide for the
potential allocation of orders, in whole or in part, in an equal
percentage based on the number of market participants quoting at the
best bid or offer. ISE Rule 713. Therefore, the proposed ISE rule
text does not reference the restriction contained in CBOE Rule
8.3(c)(vi).
---------------------------------------------------------------------------

2. Statutory Basis
    The basis under the Act for this proposed rule change is found in
Section 6(b)(5),\7\ in that the proposed change is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest.
In particular, the proposal will promote competition by increasing the
number of competitive quotes in active options classes traded on the
Exchange. The proposed rule change is consistent with the current CMM
membership structure because it requires market makers to use their
membership points in order to enter multiple quotes. Additionally, the
proposed rule change is non-discriminatory in that each CMM is able to
choose how to use their membership points. Accordingly, the Exchange
believes that the proposed rule change is consistent with the
requirements of the Exchange Act.
---------------------------------------------------------------------------

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

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

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

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    Within 45 days of the publication date of this notice or within
such longer period (1) as the Commission may designate up to 45 days of
such date if it finds such longer period to be appropriate and
publishes its reasons for so finding or (2) as to which the self-
regulatory organization consents, the Commission will:
    (a) By order approve or disapprove such Proposed Rule Change; or
    (b) Institute proceedings to determine whether the Proposed Rule
Change should be disapproved.

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 email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2012-52 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-ISE-2012-52. This file
number should be included on the subject line if email 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 NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the 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-ISE-2012-52 and should be
submitted on or before July 16, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-15380 Filed 6-22-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: August 23, 2006 (Volume 71, Number 163)]
[Notices]
[Page 49448-49450]
[DOCID:fr23au06-63]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0505; FRL-8073-2]

Notice of Filing of a Pesticide Petition for Establishment of
Regulations for Residues of Myclobutanil in or on Soybean Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of
myclobutanil in or on soybean commodities.

DATES: Comments must be received on or before September 22, 2006.

ADDRESSES:  Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0505 and pesticide petition number (PP)
5F6997, by one of the following methods:
     Federal eRulemaking Portal:  http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0505. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you

consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov Web site is an anonymous
access system, which means EPA will not know your identity
or contact information unless you provide it in the body of your
comment. If you send an e-mail comment directly to EPA without going
through regulations.gov, your e-mail address will be automatically
captured and included as part of the comment that is placed in the
docket and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses.
    Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation
of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Lisa Jones, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>, e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

     1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
     2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. What Action is the Agency Taking?

    EPA is printing a summary of a pesticide petition received under
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, proposing the establishment or amendment of regulations in
40 CFR part 180 for residues of pesticide chemicals in or on various
food commodities. EPA has determined that this pesticide petition
contains data or information regarding the elements set forth in FFDCA
section 408(d)(2); however, EPA has not fully evaluated the sufficiency
of the submitted data at this time or whether the data support granting
of the pesticide petition. Additional data may be needed before EPA
rules on this pesticide petition.
    Pursuant to 40 CFR 180.7(f), a summary of the petition included in
this notice, prepared by the petitioner along with a description of the
analytical method available for the detection and measurement of the
pesticide chemical residues is available on EPA's Electronic Docket at
http://www.regulations.gov. To locate this information on the home page

of EPA's Electronic Docket, select ``Quick Search'' and type the OPP
docket ID number. Once the search has located the docket, clicking on
the ``Docket ID'' will bring up a list of all documents in the docket
for the pesticide including the petition summary.

New Tolerance

    PP 5F6997. Dow AgroSciences, 9330 Zionsville Road, Indianapolis, IN
46268, proposes to establish a tolerance for residues of the fungicide
myclobutanil in or on food and feed commodities soybean, aspirated
grain fractions at 1.1 parts per million (ppm); soybean, forage at 5.0
ppm; soybean, hay at 13.0 ppm; soybean, hulls at 0.06 ppm; soybean,
meal at 0.03 ppm; soybean, oil at 0.1 ppm; and soybean, seed at 0.05
ppm. The validated analytical method limit of quantitation (LOQ) and
the limit of detection (LOD) were 0.01 ppm and 0.003 ppm, respectively,
for all soybean matrices. Final samples were filtered and the final
solutions were analyzed using on-line solid phase extraction coupled to
high performance liquid chromatography with positive-ion atmospheric
pressure chemical ionization (APCI) tandem mass spectrometry (LC/MS/
MS).

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: August 9, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E6-13661 Filed 8-22-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 83, Number 22 (Thursday, February 1, 2018)]
[Notices]
[Page 4726]
[FR Doc No: 2018-01958]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2001-10214]

Petition for Waiver of Compliance

    Under part 211 of Title 49 of the Code of Federal Regulations
(CFR), this provides the public notice that on December 22, 2017, the
Minnesota Northern Railroad (MNN) petitioned the Federal Railroad
Administration (FRA) for an extension of a waiver from certain
provisions of the Federal railroad safety regulations contained at 49
CFR part 223. FRA assigned the petition Docket Number FRA-2001-10214.
    Specifically, the MNN seeks to extend its existing waiver from 49
Code of Federal Regulations (CFR) Sec.  223.13, regarding the glazing
on caboose (MNN 019.
    The MNN states that the circumstances at the time of the original
grant of waiver have not changed. The caboose is still only used on
special occasions as an office car for officials and private persons
for railroad business purposes. The territory that it operates in is
primarily rural.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE, W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by March 19, 2018 will be considered by FRA
before final action is taken. Comments received after that date will be
considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. DOT posts these comments, without edit, including
any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the
privacy notice of regulations.gov.

    Issued in Washington, DC.
Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2018-01958 Filed 1-31-18; 8:45 am]
 BILLING CODE 4910-06-P


\105\ See, for example, letters from AFL-CIO, Center, CFA,
Deloitte, and PwC.
---------------------------------------------------------------------------

    Other commenters raised the issue of a rotational approach specific
to multi-location considerations. For example, commenters suggested
that the guidance allow for rotation of locations based upon risk (for
example, once every three years).\106\ However, some commenters
suggested that the risk-based approach provided in the proposed
guidance would appropriately allow companies to vary testing in
locations based more on risk than coverage, which would improve the
efficiency of their assessment.\107\
---------------------------------------------------------------------------

    \106\ See, for example, letter from CSC.
    \107\ See, for example, letters from MSFT, New York State
Society of Certified Public Accountants, and Plains Exploration &
Production Company.
---------------------------------------------------------------------------

    After considering the comments, the Commission has retained the
guidance substantially as proposed. We did not introduce a concept that
allows management to eliminate from its annual evaluation those
controls that are necessary to adequately address financial reporting
risks. For example, management cannot decide to include controls for a
particular location or process within the scope of its evaluation only
once every three years or exclude controls from the scope of its
evaluation based on prior year evaluation results. To have a reasonable
basis for its assessment of the effectiveness of ICFR, management must
have sufficient evidence supporting the operating effectiveness of all
aspects of its ICFR as of the date of its assessment. The guidance
provides a framework to assist management in making judgments regarding
the nature, timing and extent of evidence needed to support its
assessment. Management can use this framework to scale its evaluation
methods and procedures in response to the risks associated with both
the financial reporting elements and related controls in its particular
facts and circumstances.
    However, the guidance has been clarified to reflect that
management's experience with a control's operation both during the year
and as part of its prior year assessment(s) may influence its decisions
regarding the risk that controls will fail to operate as designed.
This, in turn, may have a corresponding impact on the evidence needed
to support management's conclusion that controls operated effectively
as of the date of management's assessment.
Nature of On-Going Monitoring Activities
    Commenters expressed concern that, as defined in the proposal, some
on-going monitoring activities would not be deemed to provide
sufficient evidence.\108\ Other commenters were concerned that the
guidance placed too much emphasis on the amount of evidence that could
be obtained from on-going monitoring activities and called for further
examples of when they may provide sufficient evidence and when direct
testing would be required.\109\ With regard to self-assessments,
commenters suggested that self-assessments can be an integral source of
evidence when their effective operation is verified by direct testing
over varying periods of time based on the manner in which the self-
assessments were conducted and on the level of risk associated with the
controls.\110\ Other commenters requested the proposed guidance be
revised to clarify how, based on the definitions provided, self-
assessments differed from direct testing.\111\
---------------------------------------------------------------------------

    \108\ See, for example, letters from BASF and Cees Klumper &
Matthew Shepherd (C. Klumper & M. Shepherd).
    \109\ See, for example, letters from Center and EY.
    \110\ See, for example, letters from GT and C. Klumper & M.
Shepherd.
    \111\ See, for example, letter from Cardinal.
---------------------------------------------------------------------------

    Some commenters questioned the sufficiency of evidence that would
result from management's daily interaction with controls and requested
more specifics on when it would be appropriate as a source of evidence
\112\ and how management should demonstrate that its daily interaction
with controls provided it with sufficient evidence to have a reasonable
basis to

assess whether the operation of controls was effective.\113\
---------------------------------------------------------------------------

    \112\ See, for example, letters from BDO, EY, Ohio, and Tatum.
    \113\ See, for example, letter from Ohio.
---------------------------------------------------------------------------

    Based on the feedback received, we modified the discussion of on-
going monitoring activities, including self-assessments, and direct
testing to clarify how the evidence obtained from each of the
activities can vary. As commenters in this area noted, on-going
monitoring, including self-assessments, encompasses a wide array of
activities that can be performed by a variety of individuals within an
organization. These individuals have varying degrees of objectivity,
ranging from internal auditors to the personnel involved in business
processes, and can include both those responsible for executing a
control as well as those responsible for overseeing its effective
operation. Because of the varying degrees of objectivity, the
sufficiency of the evidence management obtains from on-going monitoring
activities is determined by the nature of the activities (that is, what
they entail and how they are performed).
    We clarified the proposed guidance to indicate that when evaluating
the objectivity of personnel, management is not required to make an
absolute conclusion regarding objectivity, but rather should recognize
that personnel will have varying degrees of objectivity based on, among
other things, their job function, their relationship to the control
being evaluated, and their level of authority and responsibility within
the organization. Management should consider the ICFR risk of the
controls when determining whether the objectivity of the personnel
involved in the monitoring activities results in sufficient evidence.
For example, for areas of high ICFR risk, management's on-going
monitoring activities may provide sufficient evidence when the
monitoring activities are carried out by individuals with a high degree
of objectivity. However, when management's support includes evidence
obtained from activities performed by individuals who are not highly
objective, management would ordinarily supplement the evidence with
some degree of direct testing by individuals who are independent from
the operation of the control to corroborate the information from the
monitoring activity.
    With regard to requests for more guidance related to management's
daily interaction, we have adopted the guidance substantially as
proposed. We believe that in smaller companies, management's daily
interaction with the operation of controls may provide it with
sufficient evidence to assess whether controls are operating
effectively. The guidance is not intended to limit management's
flexibility with regard to the areas of ICFR where its interaction can
provide it with sufficient evidence or the manner by which management
obtains knowledge of the operation of the controls. However, as noted
in the guidance, daily interaction as a source of evidence for the
operation of controls applies to management who are responsible for
assessing the effectiveness of ICFR and whose knowledge about the
effective operation is gained from its on-going direct knowledge and
direct supervision of controls. In addition, the evidence management
maintains in support of its assessment should include the design of the
controls that adequately address the financial reporting risks as well
as how its interaction provides an adequate basis for its assessment of
the effectiveness of ICFR.
Time Period Covered by Evaluation Procedures
    Commenters requested that the guidance allow for, and encourage,
management to gather evidence throughout the year to support its
assessment in lieu of having to gather some evidence close to or as-of
year-end.\114\ These commenters believed that such guidance would
encourage companies to better integrate their evaluation procedures
into the normal activities of their daily operations, spread the effort
more evenly throughout the year, and help reduce the strain on
resources at year-end when company personnel are preparing the annual
financial statements and complying with other financial reporting
activities.
---------------------------------------------------------------------------

    \114\ See, for example, letters from Eli Lilly, The Financial
Services Roundtable, and Neenah Paper, Inc.
---------------------------------------------------------------------------

    We agree with the comments received in this area with respect to
allowing management the flexibility to gather evidence in support of
its assessment during the year. Since management's assessment is
performed as of the end of its fiscal year-end, the evidence management
utilizes to support its assessment would ordinarily include a
reasonable period of time during the year, including some evidence as
of the date of its assessment. However, the proposal was not intended
to limit management's flexibility to conduct its evaluation activities
during the year. Rather, the proposed guidance was intended to provide
management with the ability to perform a variety of activities covering
periods of time that vary based on its assessment of risk in order to
provide it with a sufficient basis for its evaluation. This could
include, for example, a strategy that employs direct testing over a
control during the year (but prior to year-end), that is supplemented
with a self-assessment activity at year-end. As a result, we have
adopted the guidance related to the period of time for which management
should obtain evidence of the operation of controls substantially as
proposed.
Supporting Evidential Matter
    Commenters expressed support for the guidance in the proposal
related to the supporting evidential matter and believed it would allow
management to make better judgments and allow for sufficient
flexibility to vary the nature and extent of evidence based on the
company's particular facts and circumstances.\115\ Other commenters
observed that a certain level of documentation was required in order to
facilitate an efficient and effective audit and suggested the guidance
explicitly state this fact and/or clarify how the guidance for
management was intended to interact with the requirements provided to
auditors.\116\ One commenter requested that we clarify our intention
related to the audit committee's involvement in the review of
evidential matter prepared by management in support of its
assessment.\117\
---------------------------------------------------------------------------

    \115\ See, for example, letters from BR, EY, Hudson Financial
Solutions (HFS), and MSFT.
    \116\ See, for example, letters from Center, Deloitte, EY, GT,
M&P, MetLife, MDFC, PwC, and N. Stofberg.
    \117\ See, for example, letter from ABA.
---------------------------------------------------------------------------

    After consideration of the comments, we are adopting the guidance
substantially as proposed. We continue to believe that management
should have considerable flexibility as to the nature and extent of the
documentation it maintains to support its assessment, while at the same
time maintaining sufficient evidence to provide reasonable support for
its assessment. Providing specific guidelines and detailed examples of
various types of documentation would potentially limit the flexibility
we intended to afford management.
    With respect to the concerns raised regarding the interaction of
the proposed guidance and the audit requirements, we determined that no
changes were necessary. Similar to an audit of the financial
statements, the nature and extent of evidential matter maintained by
management may impact how an auditor conducts the audit and the
efficiency of the audit. We believe

that the most efficient implementation by management and the auditor is
achieved when flexibility exists to determine the appropriate manner by
which to complete their respective tasks. However, we also believe that
the Proposed Auditing Standard allows auditors sufficient flexibility
to consider various types of evidence utilized by management. The audit
standard allows auditors to adjust their approach in certain
circumstances, if necessary, so that audit procedures should not place
any undue burden or expense on management's evaluation process.

F. Evaluation of Control Deficiencies

1. Summary of the Proposal
    The proposal directed management to evaluate each control
deficiency that comes to its attention in order to determine whether
the deficiency, or combination of control deficiencies, is a material
weakness. The proposal defined a material weakness as a deficiency, or
combination of deficiencies, in ICFR such that there is a reasonable
possibility that a material misstatement of the company's annual or
interim financial statements will not be prevented or detected on a
timely basis by the company's ICFR. The proposal contained guidance on
the aggregation of deficiencies by indicating that multiple control
deficiencies that affect the same financial reporting element increase
the likelihood of misstatement and may, in combination, constitute a
material weakness, even though such deficiencies may be individually
insignificant. The proposal also highlighted four circumstances that
were strong indicators that a material weakness in ICFR existed. In
summary, the following four items were listed:
     An ineffective control environment, including
identification of fraud of any magnitude on the part of senior
management; significant deficiencies that remain unaddressed after some
reasonable period of time; and ineffective oversight by the audit
committee (or entire board of directors if no audit committee exists).
     Restatement of previously issued financial statements to
reflect the correction of a material misstatement.
     Identification by the auditor of a material misstatement
of financial statements in the current period under circumstances that
indicate the misstatement would not have been discovered by the
company's ICFR.
     For complex entities in highly regulated industries, an
ineffective regulatory compliance function.
2. Comments on the Proposal and Revisions Made
Definition of Material Weakness
    Commenters expressed concern about differences between our proposed
definition of material weakness and that proposed by the PCAOB in its
Proposed Auditing Standard and requested that the two definitions be
aligned.\118\ Commenters provided feedback on the reasonably possible
threshold for determining the likelihood of a potential material
misstatement as well as the reference to interim financial statements
for determining whether a potential misstatement could be material.
Commenters also suggested that a single definition of material weakness
be established for use by both auditors and management and that
definition be established by the SEC in its rules.\119\ Based on
comments on the proposal, we are amending Exchange Act Rule 12b-2 and
Rule 1-02 of Regulation S-X to define the term material weakness.
Further discussion and analysis of the definition of material weakness
and commenter feedback can be found in that rule release.\120\
---------------------------------------------------------------------------

    \118\ See, for example, letters from EEI, FEI CCR, FEI SPCTF,
ICAEW, N. Stofberg, and SVLG.
    \119\ See, for example, letters from FEE and ICAEW.
    \120\ Release No. 34-55928.
---------------------------------------------------------------------------

Strong Indicators of a Material Weakness
    Commenters noted there were differences in the list of strong
indicators included in the proposal and the list of strong indicators
included in the Proposed Auditing Standard, raising concern that the
failure of the two proposals to provide similar guidance would cause
unnecessary confusion between management and auditors.\121\ Commenters
also provided suggested changes, additions or deletions to
circumstances that were included on the list of strong indicators. For
example, commenters raised questions about the ``identification of
fraud of any magnitude on the part of senior management,'' questioning
the appropriateness of the term ``of any magnitude'' or which
individuals were encompassed in the term ``senior management.'' \122\
Commenters also felt the Commission's proposed list of indicators
should be expanded to include the indicator relating to an ineffective
internal audit function or risk assessment function that was included
in the Proposed Auditing Standard.\123\ One commenter felt that the
list of strong indicators needed to be made more specific, and should
include more illustrative examples.\124\ Another commenter stated that
the indicator of ``significant deficiencies that have been identified
and remain unaddressed after some reasonable period of time'' should be
clarified to mean unremediated deficiencies.\125\ Other commenters
suggested that the list of strong indicators be eliminated completely,
stating that designating these items as strong indicators creates a
presumption that such items are, in fact, material weaknesses, and may
impede the use of judgment to properly evaluate the identified control
deficiency in light of the individual facts and circumstances.\126\
Commenters also felt the Commission should clearly indicate that a
company may determine that no deficiency exists despite the fact that
one of the identified strong indicators was present.\127\
---------------------------------------------------------------------------

    \121\ See, for example, letters from BDO, BR, Center, Cleary,
CSC, Deloitte, KPMG, M&P, and Schneider Downs & Co., Inc.
(Schneider).
    \122\ See, for example, letters from 100 Group, Eli Lilly, FEI
CCR, and P&G.
    \123\ See, for example, letters from BR, Crowe Chizek & Company
LLC (Crowe), Deloitte, and M&P.
    \124\ See, for example, letter from Chamber.
    \125\ See, for example, letter from EEI.
    \126\ See, for example, letters from Cleary, Institute of
Internal Auditors (IIA), and NYC Bar.
    \127\ See, for example, letters from Chamber, Cleary, CSC, PPL,
and Schneider.
---------------------------------------------------------------------------

    After consideration of the comments, we have decided to modify the
proposed guidance. We believe judgment is imperative in determining
whether a deficiency is a material weakness and that the guidance
should encourage management to use that judgment. As a result, we have
modified the guidance to emphasize that the evaluation of control
deficiencies requires the consideration of all of the relevant facts
and circumstances. We agreed with the concerns that an overly detailed
list may create a list of de facto material weaknesses or
inappropriately suggest that identified control deficiencies not
included in the list are of lesser importance. At the same time,
however, we continue to believe that highlighting certain circumstances
that are indicative of a material weakness provides practical
information for management. As a result, rather than referring to
``strong indicators,'' the final guidance refers simply to
``indicators.'' This change should further emphasize that the presence
of one of the indicators does not mandate a conclusion that a material
weakness exists. Rather management should apply professional judgment
in this area. These examples include indicators related to the results
of the financial statement audit, such as material audit adjustments
and restatements, and

indicators related to the overall evaluation of the company's oversight
of financial reporting, such as the effectiveness of the audit
committee and incidences of fraud among senior management. These
examples are by no means an exhaustive list. For example, under COSO,
risk assessment and monitoring are two of the five components of an
effective system of internal control. If management concludes that an
internal control component is not effective, or if required entity-
level or pervasive elements of ICFR are not effective, it is likely
that internal control is not effective.
    Lastly, we agreed with commenters that it is appropriate for the
Commission's guidance in this area to mirror the PCAOB's auditing
standard. As a result, we have worked with the PCAOB in reaching
conclusions regarding the guidance in this area, and we anticipate the
PCAOB's auditing standard will align with our final management
guidance.

G. Management Reporting and Disclosure

    Comment letters expressed various viewpoints regarding the
information management provides as part of its report on the
effectiveness of ICFR. For example, commenters raised concerns
regarding the ``point in time'' assessment and suggested various
alternative approaches.\128\ Commenters also made suggestions regarding
the disclosures management provides when a material weakness has
occurred. Certain commenters felt the suggested disclosures indicated
in the proposing release should be mandatory,\129\ while other
commenters wanted the Commission to specify where in the Form 10-K
management must provide its disclosures.\130\ Commenters also requested
that the Commission include in its release additional possible
disclosures for consideration by management to include in its
report.\131\
---------------------------------------------------------------------------

    \128\ See, for example, letters from BHP Billiton Limited, Eli
Lilly, and IIA.
    \129\ See, for example, letters from HFS, IDW, and Tatum.
    \130\ See, for example, letters from Crowe and KPMG.
    \131\ See, for example, letters from PCG Worldwide Limited and
PepsiCo, Inc. (Pepsi).
---------------------------------------------------------------------------

    In addition, commenters expressed concerns regarding the language
in the Proposing Release with respect to management's ability to
determine that ICFR is ineffective due solely to, and only to the
extent of, the identified material weakness(es). Some commenters felt
that this language was essentially the same as a qualified opinion,
which is prohibited by the guidance,\132\ while two others stated that
the Commission needed to provide additional guidance around the
circumstances under which this approach would be appropriate.\133\
---------------------------------------------------------------------------

    \132\ See, for example, letters from BDO and CFA.
    \133\ See, for example, letters from Crowe and Deloitte.
---------------------------------------------------------------------------

    Based on the feedback we received, we have eliminated this from the
final interpretive guidance and revised the proposed guidance to simply
state that management may not state that the company's ICFR is
effective. However, management may state that controls are ineffective
for specific reasons.
    Additionally, certain of the requests received seemed inconsistent
with the statutory obligation. For example, Section 404(a)(2) of
Sarbanes-Oxley requires that management perform the assessment as of
the end of its most recent fiscal year. As a result, we do not believe
any further changes to the proposed guidance around management's
expression of its assessment of the effectiveness of ICFR are
necessary.

H. Previous Staff Guidance and Staff Frequently Asked Questions

    Commenters raised questions regarding the status of guidance
previously issued by the Commission and its staff, on May 16,
2005,\134\ as well as the Frequently Asked Questions (``FAQs'').\135\
Some commenters requested the FAQs be retained in their entirety,\136\
while others requested that some particular FAQs be retained.\137\ As
we indicated in the proposed guidance, the May 2005 guidance remains
relevant. Additionally, we have instructed the staff to review the FAQs
and, as a result of the final issuance of this guidance, update them as
appropriate.
---------------------------------------------------------------------------

    \134\ Commission Statement on Implementation of Internal Control
Reporting Requirements, Press Release No. 2005-74 (May 16, 2005);
Division of Corporation Finance and Office of the Chief Accountant:
Staff Statement on Management's Report on Internal Control Financial
Reporting (May 16, 2005), available at http://www.sec.gov/spotlight/soxcom/.htm
.

    \135\ Office of the Chief Accountant and Division of Corporation
Finance: Management's Report on Internal Control Over Financial
Reporting and Certification of Disclosure in Exchange Act Periodic
Reports Frequently Asked Questions (revised Oct. 6, 2004), available
at http://www.sec.gov/info/accountants/controlfaq1004.htm.

    \136\ See, for example, letters from BP p.l.c. (BP), GT, IIA,
ISACA, MSFT, and Tatum.
    \137\ See, for example, letters from BDO, EY, KPMG, and Stantec
Inc.
---------------------------------------------------------------------------

I. Foreign Private Issuers

    The Commission received comments directed towards the information
included in the proposed guidance related to foreign private issuers.
While three commenters noted that no additional guidance for foreign
private issuers was necessary,\138\ other commenters suggested changes.
Commenters raised concerns regarding potential duplicative efforts and
costs foreign registrants are subject to, as a result of similar
regulations in their local jurisdictions.\139\ These commenters
requested that the Commission attempt to minimize or remove any
duplicative requirements, with some requesting the Commission exempt
foreign registrants entirely from the ICFR reporting requirements if
the registrant was subject to similar regulations in their home
country. Other commenters raised concerns relating to the unique
challenges that foreign registrants face in evaluating their ICFR,
including language and cultural differences and international legal
differences.\140\
---------------------------------------------------------------------------

    \138\ See, for example, letters from BP, Manulife, and Pepsi.
    \139\ See, for example, letters from 100 Group, Banco
Ita[uacute] Holding Financeira SA, CCMR, Eric Fandrich, and FEI CCR.
    \140\ See, for example, letters from IIA and GT.
---------------------------------------------------------------------------

    Commenters also made suggestions regarding how the reconciliation
to U.S. GAAP should be handled in the evaluation of ICFR. Certain
commenters expressed support for the Commission's position that foreign
private issuers should scope their evaluation effort based on the
financial statements prepared in accordance with home country GAAP,
rather than based on the reconciliation to U.S. GAAP.\141\ However,
other commenters requested that the Commission exempt the
reconciliation to U.S. GAAP from the scope of the evaluation
altogether,\142\ while others sought further clarification as to
whether and how the reconciliation was included in the evaluation of
ICFR,\143\ with one commenter suggesting the Commission staff publish
additional Frequently Asked Questions to address any implementation
issues.\144\ One commenter requested the Commission exclude from the
evaluation process those financial statement disclosures that are
required by home country GAAP but not under U.S. GAAP to minimize the
differences in the ICFR evaluation efforts between U.S. registrants and
foreign filers as much as possible.\145\
---------------------------------------------------------------------------

    \141\ See, for example, letters from 100 Group, BDO, and ICAEW.
    \142\ See, for example, letters from CCMR, Cleary, EALIC, and
NYC Bar.
    \143\ See, for example, letters from Deloitte, EY, KPMG, and N.
Stofberg.
    \144\ See, for example, letter from Ohio.
    \145\ See, for example, letter from ING.

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

    After considering the comments received, the Commission has
determined not to exempt foreign registrants from the ICFR reporting
requirements, regardless of whether they are subject to similar home
country requirements. The Commission's requirement for all issuers to
complete an evaluation of ICFR is not derived from the Commission's
Interpretive Guidance for Management; this requirement has been
established by Congress. Further, the Commission does not believe it is
appropriate to exclude the U.S. GAAP reconciliation from the scope of
the evaluation as long as it is a required element of the financial
statements. Currently, however, the Commission is evaluating, as part
of another project, the acceptance of International Financial Reporting
Standards (``IFRS'') as published by the International Accounting
Standards Board (``IASB'') without reconciliation to U.S. GAAP.\146\
---------------------------------------------------------------------------

    \146\ In a press release on April 24, 2007, the Commission
announced its next steps pertaining to acceptance of IFRS without
reconciliation to U.S. GAAP. In that press release, the Commission
stated that it anticipates issuing a Proposing Release in summer
2007 that will request comments on proposed changes to the
Commission's rules which would allow the use of IFRS, as published
by the IASB, without reconciliation to U.S. GAAP in financial
reports filed by foreign private issuers that are registered with
the Commission. The press release is available at http://www.sec.gov/news/press/2007/2007-72.htm
.

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

    In light of the comment letters, the Commission realizes that there
are certain implementation concerns and issues that are unique to
foreign private issuers. As a result, the Commission has instructed the
staff to consider whether these items should be addressed in a
Frequently Asked Questions document.

List of Subjects in 17 CFR Part 241

    Securities.

Text of Amendments

0
For the reasons set out in the preamble, the Commission is amending
Title 17, chapter II, of the Code of Federal Regulations as follows:

PART 241--INTERPRETATIVE RELEASES RELATING TO THE SECURITIES
EXCHANGE ACT OF 1934 AND GENERAL RULES AND REGULATIONS THEREUNDER

0
Part 241 is amended by adding Release No. 34-55929 and the release date
of June 20, 2007 to the list of interpretative releases.

    Dated: June 20, 2007.

    By the Commission.
Nancy M. Morris,
Secretary.
 [FR Doc. E7-12299 Filed 6-26-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 77, Number 163 (Wednesday, August 22, 2012)]
[Proposed Rules]
[Pages 50648-50649]
[FR Doc No: 2012-20657]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2012-0653; Airspace Docket No. 12-ASW-3]

Proposed Amendment of Class E Airspace; Breckenridge, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend Class E airspace at
Breckenridge, TX. Additional controlled airspace is necessary to
accommodate new Standard Instrument Approach Procedures (SIAPs) at
Stephens County Airport. The FAA is taking this action to enhance the
safety and management of Instrument Flight Rules (IFR) operations for
SIAPs at the airport. Geographic coordinates of the airport would also
be updated.

DATES: 0901 UTC. Comments must be received on or before October 9,
2012.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You
must identify the docket number FAA-2012-0653/Airspace Docket No. 12-
ASW-3,

at the beginning of your comments. You may also submit comments through
the Internet at http://www.regulations.gov. You may review the public
docket containing the proposal, any comments received, and any final
disposition in person in the Dockets Office between 9:00 a.m. and 5:00
p.m., Monday through Friday, except Federal holidays. The Docket Office
(telephone 1-800-647-5527), is on the ground floor of the building at
the above address.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone: (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2012-0653/
Airspace Docket No. 12-ASW-3.'' The postcard will be date/time stamped
and returned to the commenter.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Central Service Center, 2601
Meacham Blvd., Fort Worth, TX 76137.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking<PHONE_NUMBER>, to
request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    This action proposes to amend Title 14, Code of Federal Regulations
(14 CFR), part 71 by amending Class E airspace extending upward from
700 feet above the surface to accommodate new standard instrument
approach procedures at Stephens County Airport, Breckenridge, TX.
Controlled airspace is needed for the safety and management of IFR
operations at the airport. The airport's geographic coordinates also
would be updated to coincide with the FAA's aeronautical database.
    Class E airspace areas are published in Paragraph 6005 of FAA Order
7400.9V, dated August 9, 2011 and effective September 15, 2011, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document would be published subsequently in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend controlled airspace at Stephens County Airport,
Breckenridge, TX.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

The Proposed Amendment

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

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

    1. The authority citation for part 71 continues to read as follows:

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of FAA Order
7400.9V, Airspace Designations and Reporting Points, dated August 9,
2011, and effective September 15, 2011, is amended as follows:

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

* * * * *

ASW TX E5 Breckenridge, TX [Amended]

Stephens County Airport, TX
    (Lat. 32[deg]43'08'' N., long. 98[deg]53'30'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Stephens County Airport, and within 2
miles each side of the 180[deg] bearing from the airport extending
from the 6.4-mile radius to 10.4 miles south of the airport.

    Issued in Fort Worth, TX on August 1, 2012.
David. P. Medina,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2012-20657 Filed 8-21-12; 8:45 am]
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