[Federal Register Volume 87, Number 54 (Monday, March 21, 2022)]
[Notices]
[Pages 15989-15990]
[FR Doc No: 2022-05880]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9623-01-OMS]

National and Governmental Advisory Committees to the U.S.
Representative to the Commission for Environmental Cooperation (CEC)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meeting.

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SUMMARY: Under the Federal Advisory Committee Act, the Environmental
Protection Agency (EPA) gives notice of a public meeting of the
National Advisory Committee (NAC) and the Government Advisory Committee

(GAC). The NAC and GAC provide advice the EPA Administrator a broad
range of environmental policy, technology, and management issues. NAC/
GAC members represent academia, business/industry, non-governmental
organizations, and state, local and tribal governments. The purpose of
this meeting is to provide advice to the EPA Administrator, regarding a
new draft project description for the CEC Operational Plan and discuss
how to integrate climate change and environmental justice in the work
of the CEC. A copy of the meeting agenda will be posted at https://www.epa.gov/faca/nac-gac.

DATES: NAC/GAC will hold a public virtual meeting on April 28, 2022
from 11:00 a.m. to 3:00 p.m. (EST).

ADDRESSES: The meeting will be conducted virtually. To gain access to
the meeting please contact Oscar Carrillo at<PHONE_NUMBER> or
[email protected].

FOR FURTHER INFORMATION CONTACT: Oscar Carrillo, Program Analyst,
[email protected],<PHONE_NUMBER>, U.S. EPA, Office of Resources
and Business Operations; Federal Advisory Committee Management Division
(MC1601M), 1200 Pennsylvania Avenue NW, Washington, DC 20460.

SUPPLEMENTARY INFORMATION: Requests to make oral comments or to provide
written comments to NAC/GAC should be sent to Oscar Carrillo at
[email protected] by April 21, 2022. Virtual meeting is open to
the public. Members of the public wishing to participate in the meeting
should contact Oscar Carrillo via email or by calling<PHONE_NUMBER> no
later than April 7, 2022.
    Meeting Access: Information regarding accessibility and/or
accommodations for individuals with disabilities should be directed to
Oscar Carrillo at the email address or phone number listed above. To
ensure adequate time for processing, please make requests for
accommodations at least 10 days prior to the teleconference meeting.

    Dated: March 15, 2022.
Oscar Carrillo,
Program Analyst.
[FR Doc. 2022-05880 Filed 3-18-22; 8:45 am]
BILLING CODE 6560-50-P


From:
"Ulatowski, Rhiannon"<EMAIL_ADDRESS>Sent:
Fri, 03 Mar 2023 17:39:25
To:
"Jones; DonnaLee"<EMAIL_ADDRESS>Coke ICR2<EMAIL_ADDRESS>"Maicher; Thomas W."<EMAIL_ADDRESS>"Kurdila; Julianne"<EMAIL_ADDRESS>"Kistler; Katie E"<EMAIL_ADDRESS>"Zavoda; Rich"<EMAIL_ADDRESS>Subject:
Cleveland-Cliffs Burns Harbor - Coke 114 Request - Enclosure 2 Fugitive Monitoring Data 1 of 2 emails
Dear Mr. French and Dr. Jones:

Cleveland-Cliffs Burns Harbor LLC is timely submitting the attached Fugitive Monitoring data and report for the first 3-month set of results, as required by Enclosure 2 of the Coke Information Collection Request (ICR) dated June 28, 2022.  The EPA-provided Excel file, report with appendices is being submitted in two separate emails due to the more than 1,000 pages of documentation.

Please let me know if you have any questions,

Rhiannon ulatowski
Environmental Engineer-Air
p<PHONE_NUMBER>   m<PHONE_NUMBER>
<EMAIL_ADDRESS>
CLEVELAND-CLIFFS INC.

<<Cleveland-Cliffs_BurnsHarbor_ICR_Report_3-Month_FINAL_R0_FRONTHALF.pdf>>
<<ANSWER-FUGITIVE-Coke Enc2_Test Results_CC_BH_3-Month_FINAL_R0.xlsx>>


[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Rules and Regulations]
[Pages 11885-11887]
[FR Doc No: 2015-03331]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2013-0907]
RIN 1625-AA00

Safety Zones; Upper Mississippi River Between Mile 38.0 and 46.0,
Thebes, IL; and Between Mile 78.0 and 81.0, Grand Tower, IL

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is establishing safety zones for all waters of
the Upper Mississippi River (UMR) from mile 38.0 to 46.0 and from mile
78.0 to 81.0. These safety zones are needed to protect persons,
property, and infrastructure from potential damage and safety hazards
associated with subsurface rock removal in the Upper Mississippi River.
Any deviation from the conditions and requirements put into place are
prohibited unless specifically authorized by the cognizant Captain of
the Port (COTP) Ohio Valley or his designated representatives.

DATES: This rule is effective on March 5, 2015.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2013-0907]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LT Dan McQuate, U.S. Coast Guard; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Cheryl F. Collins, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

AIS Automated Information System
BNM Broadcast Notice to Mariners
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
LNM Local Notice to Mariners
MM Mile Marker
MSU Marine Safety Unit
M/V Motor Vessel
NPRM Notice of Proposed Rulemaking
RIAC River Industry Action Committee
UMR Upper Mississippi River
USACE United States Army Corps of Engineers

A. Regulatory History and Information

    Based on forecasted historical low water on the UMR in the fall of
2012, the USACE contracted subsurface rock removal operations in
Thebes, IL to mitigate the effects of the forecasted low water event.
In order to provide additional safety measures and regulate navigation
during low water and the planned rock removal operations, the Coast
Guard published a temporary final rule in the Federal Register for an
RNA from mile 0.0 to 185.0 UMR (77 FR 75850). The RNA was in effect
from December 1, 2012 until March 31, 2013, which is when river levels
rebounded and the subsurface rock removal operation was delayed because
of high water levels. During the effective period for this temporary
RNA, restrictions were enforced for a total of approximately 45 days.
    In the fall of 2013, based on changing river conditions, low water
was again forecasted and the USACE's contracted subsurface rock removal
operations in Thebes, IL were scheduled to resume. The Coast Guard then
published a second temporary final rule in the Federal Register re-
establishing the RNA (78 FR 70222). Based on the forecasted water
levels and the plans and needs for the resumed rock removal operations,
the RNA covered a smaller river section extending from mile 0.0 to
109.9 on the UMR. The RNA was implemented to ensure the safety of the
USACE contractors and marine traffic during the actual rock removal
work, and to support the safe and timely clearing of vessel queues at
the conclusion of the work each day. The RNA was in effect from
November 4, 2013 until April 12, 2014, but was only enforced from
December 10, 2013 until February 19, 2014 due to water levels
increasing and forcing the USACE contractors to cease rock removal
operations. During the times the RNA was enforced, the Coast Guard
worked with the USACE, RIAC, and the USACE contractor to implement
river closures and various restrictions to maximize the size of tows
that could safely pass while keeping the USACE contractor crews safe.
The Coast Guard also assisted in clearing vessel queues after each
closure or restriction.
    On April 17, 2014, MSU Paducah contacted USACE St. Louis to
determine if subsurface rock removal operations will be conducted in
the Upper Mississippi River in the vicinity of Thebes, IL in future
years. USACE St. Louis reported that such operations are anticipated to
continue as river conditions permit, and that there are multiple phases
of subsurface rock removal operations remaining. On August 28, 2014
USACE St. Louis notified the Coast Guard that based on recently
acquired data, rock removal operations will also be required in the
Upper Mississippi River between miles 78.0 and 81.0 at Grand Tower, IL
in the future.
    USACE St. Louis also informed the Coast Guard that the
environmental window for these operations each year

moving forward is July 1 to April 12. However, river conditions likely
will not permit work for the majority of that timeframe each year, and
in some years river conditions may not permit any work on this project
to be completed. This project is expected to go on indefinitely when
river conditions permit during the allowable times within the
environmental windows. For continuity and based on the necessary
restrictions, USACE St. Louis requested continued involvement of the
Coast Guard for navigation expertise and facilitating restrictions with
users of the waterway and the contractor. According to USACE St. Louis,
the majority of the rock removal operations will impact vessel traffic
and requested that the Coast Guard establish restrictions under 33 CFR
part 165, Regulated Navigation Areas and Limited Access Areas to
maintain safety of navigation during the rock removal project. The
Coast determined that safety zones, one type of Limited Access Area
provided for under 33 CFR part 165, will provide the necessary
additional safety measures to ensure commerce can continue to navigate
safely while the contractors are working. These safety zones limit
access to specific areas of the river during rock removal operations
rather than creating a larger regulated area encompassing the entire
stretch of river where the work may take place.
    On November 10, 2014, an interim rule was published in the Federal
Register (79 FR 66622). This interim rule was effective upon
publication without prior notice through publication in the Federal
Register, but also invited comments regarding the creation of permanent
safety zones before the rule was published in final form. The Coast
Guard received no comments on the interim rule and no requests for
public meeting. No public meetings were held. No changes were made to
the rule as it was published in the interim rule.

B. Basis and Purpose

    The legal basis and authorities for this rule are found in 33
U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33
CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Public Law 107-295, 116 Stat.
2064; and Department of Homeland Security Delegation No. 0170.1, which
collectively authorize the Coast Guard to establish and define safety
zones.
    The purpose of these safety zones are to protect persons and
vessels while subsurface rock removal operations are ongoing on the UMR
from mile 38.0 to mile 46.0 and from mile 78.0 to mile 81.0. The
removal operations pose significant safety hazards to vessels and
mariners operating on the UMR. At the previous request of RIAC and
after reviewing best practices from the previous temporary RNAs in
effect in 2012 and 2013, the Coast Guard plans to assist in
facilitating the clearing of vessel queues in future years following
restricted access on the UMR from mile 38.0 to mile 46.0 and from mile
78.0 to mile 81.0. For these reasons, the Coast Guard is to
establishing these safety zones to limit vessel access between mile
38.0 and mile 46.0, and between mile 78.0 and mile 81.0 on the UMR.

C. Discussion of Comments, Changes and the Final Rule

    No comments were received by the Coast Guard on this rule. No
changes to the rule have been made from the interim rule and request
for comments.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes or executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    This rule establishes safety zones for vessels on all waters of the
UMR from mile 38.0 to mile 46.0, and from mile 78.0 to mile 81.0. The
safety zones listed in this final rule will only restrict vessel
traffic from entering, transiting, or anchoring within specific
sections of the UMR. Notifications of enforcement times and
restrictions put into effect for these safety zones will be
communicated to the marine community via BNM, through outreach with
RIAC, and through LNMs. Such notices provide the opportunity for
industry to plan transits accordingly and work around the schedule of
rock removal operations as necessary. The impacts on navigation will be
limited to ensuring the safety of mariners and vessels associated with
hazards presented by USACE contractor operations involving subsurface
rock removal, and the safe and timely resumption of vessel traffic
following any river closures or restrictions associated with subsurface
rock removal operations. Restrictions under these safety zones will be
the minimum necessary to protect mariners, vessels, the public, and the
environment from known or perceived risks.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    This rule will affect the following entities, some of which may be
small entities: The owners or operators of vessels intending to transit
the UMR during USACE contracted subsurface rock removal operations.
These safety zones will not have a significant economic impact on a
substantial number of small entities for the following reasons. While
the safety zones listed in this final rule will restrict vessel traffic
from entering, transiting, or anchoring within specific sections of the
UMR, this rule does allow for the intermittent passing of vessels.
Traffic in this area is limited to almost entirely recreational vessels
and commercial towing vessels subject to noticed restrictions and
requirements. Notifications to the marine community will be made
through BNM, LNM, and communications with RIAC. Notices of changes to
the safety zones and enforcement times will also be made. Additionally,
deviation from the restrictions may be requested from the COTP Ohio
Valley or designated representative and will be considered on a case-
by-case basis.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees

who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves creation of safety zones from mile 38.0
to mile 46.0, and from mile 78.0 to mile 81.0 UMR. This rule is
categorically excluded from further review under paragraph 34(g) of
Figure 2-1 of the Commandant Instruction. An environmental analysis
checklist and a categorical exclusion determination are available in
the docket where indicated under the ADDRESSES. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    Accordingly, the interim rule amending 33 CFR part 165 that
published at 77 FR 75850 on December 26, 2012, is adopted as a final
rule without change.

    Dated: December 29, 2014.
R.V. Timme,
Captain, U.S. Coast Guard, Captain of the Port Ohio Valley.
[FR Doc. 2015-03331 Filed 3-4-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 204 (Thursday, October 22, 2015)]
[Notices]
[Pages 64060-64061]
[FR Doc No: 2015-26950]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket No. DOT-OST-2010-0054]
RIN 2105-ADO4

Application To Renew Information Collection Request OMB No. 2105-
0551

AGENCY: Office of the Secretary (OST), Department of Transportation
(Department).

ACTION: Notice and request for comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35, as amended), the Department of Transportation's
Office of the Secretary is forwarding the Information Collection
Request (ICR) described below to the Office of Management and Budget
(OMB) for approval. The ICR describes the nature of the information and
the expected burden. OST published a Federal Register notice with a 60-
day comment period soliciting comments on the following collection of
information on April 16, 2015. The purpose of this notice is to allow
the public an additional 30 days from the date of this notice to submit
comments to the recently published application to renew ICR 2105-0551,
``Reporting Requirements for Disability-Related Complaints.''

DATES: Comments on this notice must be received by November 23, 2015.

ADDRESSES: Your comments should be identified by Docket No. DOT-OST-
2015-0083 and should be submitted through one of the following methods:
     Office of Management and Budget, Attention: Desk Officer
for U.S. Department of Transportation, Office of the Secretary of
Transportation, 725 17th Street NW., Washington, DC 20503.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Maegan Johnson, Office of the General
Counsel, Office of the Secretary, U.S. Department of Transportation,
1200 New Jersey Avenue SE., Washington, DC 20590,<PHONE_NUMBER> (Voice),
202-366-7152 (Fax), or<EMAIL_ADDRESS>(Email). Arrangements to
receive this document in an alternative format may be made by
contacting the above-named individuals.

SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act of 1995 (PRA)
and its implementing regulations, 5 CFR part 1320, require Federal
agencies to issue two notices seeking public comment on information
collection activities before OMB may approve paperwork packages. 44
U.S.C. 3506, 3507; 5 CFR 1320.5, 1320.8(d)(1), 1320.12. On April 16,
2015, OST published a 60-day notice in the Federal Register soliciting
comment on ICRs for which the agency was seeking OMB approval. See 80
FR 20554. OST received no comments after issuing this notice.
Accordingly, the Department has not made any changes to its anticipated
burden hours for the respondents to comply with these requirements. The
Department announces that these information collection activities have
been re-evaluated and certified under 5 CFR. 1320.5(a) and is
forwarding to OMB for review and approval pursuant to 5 CFR 1320.12(c).
    Before OMB decides whether to approve these proposed collections of
information, it must provide 30 days for public comment. 44 U.S.C.
3507(b); 5 CFR 1320.12(d). Federal law requires OMB to approve or
disapprove paperwork packages between 30 and 60 days after the 30-day
notice is published. 44 U.S.C. 3507(b)-(c); 5 CFR 1320.12(d); see also
60 FR 44978, 44983 (Aug. 29, 1995). OMB believes that the 30-day notice
informs the regulated community to file relevant comments and affords
the agency adequate time to digest public comments before it renders a
decision. 60 FR 44983 (Aug. 29, 1995). Therefore, respondents should
submit their respective comments to OMB within 30 days of publication
to best ensure their full consideration. 5 CFR 1320.12(c); see also 60
FR 44983 (Aug. 29, 1995). The summaries below describe the nature of
the ICR and the expected burden.
    Title: Reporting Requirements for Disability-Related Complaints.
    OMB Control Number: 2105-0551.
    Type of Request: Renewal of Information Collection Request.
    Background: On July 8, 2003, the Office of the Secretary published
a final rule that requires certificated U.S. and foreign air carriers
operating to, from and within the U.S. that conduct passenger-carrying
service utilizing at least one large aircraft to record complaints that
they receive alleging inadequate accessibility or discrimination on the
basis of disability. The carriers must also categorize these complaints
according to the type of disability and nature of complaint, prepare a
summary report annually of the complaints received during the preceding
calendar year, submit the report to the Department's Aviation Consumer
Protection Division, and retain copies of correspondence and

records of action taken on the reported complaints for three years. The
rule requires carriers to submit their annual report via the World Wide
Web except if the carrier can demonstrate an undue burden by doing so
and receives permission from the Department to submit it in an
alternative manner. The first required report covered disability-
related complaints received by carriers during calendar year 2004,
which was due to the Department on January 31, 2005. Carriers have been
required to submit all subsequent reports on the last Monday in January
for the prior calendar year. On November 3, 2010, OMB approved
information collection of disability-related complaints, ``Reporting
Requirements for Disability-related Complaints'' through November 30,
2013. The application to renew this information collection request was
published in the Federal Register on Thursday, April 16, 2015, 80 FR
20554.
    Respondents: Certificated U.S. and foreign air carriers operating
to, from, and within the United States that conduct passenger-carrying
service with large aircraft.

----------------------------------------------------------------------------------------------------------------
                                                                                Estimated total
                                                                             Estimated annual     annual burden
          Requirements               Number of     Frequency (per year)        burden (per             (all
                                    respondents                            respondent) (hours)     respondents)
                                                                                (hours)
----------------------------------------------------------------------------------------------------------------
Record an Categorize Complaints              175  0 to 5,000............  0 to 1,250...........          6,900
 Received.
Prepare and Submit Annual Report             175  1.....................  .5...................             87.5
Retain Correspondences and                   175  0 to 5,000............  1....................            175
 Record of Action Taken.
----------------------------------------------------------------------------------------------------------------

    Comments are invited on: (a) Whether the collection of information
is necessary for the proper performance of the functions of the
Department, including whether the information will have practical
utility; (b) the accuracy of the Department's estimate of the burden of
the proposed information collection; (c) ways to enhance the quality,
utility and clarity of the information to be collected; and (d) ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology. All comments will also become a matter of
public record.

    Issued in Washington, DC, on October 14, 2015.
Patricia Lawton,
DOT PRA Clearance Officer, Office of the DOT Chief Information Officer.
[FR Doc. 2015-26950 Filed 10-21-15; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register: November 18, 2008 (Volume 73, Number 223)]
[Rules and Regulations]
[Page 68332-68333]
[DOCID:fr18no08-11]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 601

[Docket No. FDA-2006-N-0364] (formerly Docket No. 2006N-0466)

Exceptions or Alternatives to Labeling Requirements for Products
Held by the Strategic National Stockpile; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the
biologics regulations to reincorporate a regulation that was
inadvertently removed. This action is being taken to correct the
regulations.

DATES: This rule is effective November 18, 2008.

FOR FURTHER INFORMATION CONTACT: Tiffany J. Brown, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: FDA has discovered that an error appeared in
the agency's codified regulations for part 601 (21 CFR part 601). In
the Federal Register of December 28, 2007 (72 FR 73589), FDA published
an interim final rule that inadvertently revised Sec.
601.12(f)(3)(i)(D) (21 CFR 601.12(f)(3)(i)(D)) instead of adding a new
paragraph, Sec.  601.12(f)(3)(i)(E). Accordingly, Sec.
601.12(f)(3)(i)(D), which was added in the Federal Register of January
24, 2006 (71 FR 3922), is being reincorporated into the regulations to
replace current Sec.  601.12(f)(3)(i)(D); current Sec.
601.12(f)(3)(i)(D) is being redesignated as Sec.  601.12(f)(3)(i)(E).
This document corrects the errors described previously. Publication of
this document constitutes final action under the Administrative
Procedure Act (5 U.S.C. 553). FDA has determined that notice and public
comment are unnecessary because this amendment is nonsubstantive.

List of Subjects in 21 CFR Part 601

    Administrative practice and procedure, Biologics, Confidential
business information.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR part 601 is amended as follows:

PART 601--LICENSING

0
1. The authority citation for 21 CFR part 601 continues to read as
follows:

    Authority: 15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353,
355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C.
216, 241, 262, 263, 264; sec 122, Pub. L. 105-115, 111 Stat. 2322
(21 U.S.C. 355 note).

0
2. In Sec.  601.12, redesignate paragraph (f)(3)(i)(D) as paragraph
(f)(3)(i)(E) and add new paragraph (f)(3)(i)(D) to read as follows:

Sec.  601.12  Changes to an approved application.

* * * * *
    (f) * * *
    (3)(i) * * *
    (D) A change to the information required in Sec.  201.57(a) of this
chapter as follows:
    (1) Removal of a listed section(s) specified in Sec.  201.57(a)(5)
of this chapter; and
    (2) Changes to the most recent revision date of the labeling as
specified in Sec.  201.57(a)(15) of this chapter.
* * * * *

    Dated: November 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-27254 Filed 11-17-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 85, Number 87 (Tuesday, May 5, 2020)]
[Notices]
[Page 26703]
[FR Doc No: 2020-09502]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4511-DR; Docket ID FEMA-2020-0001]

Commonwealth of the Northern Mariana Islands; Major Disaster and
Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the Commonwealth of the Northern Mariana Islands (FEMA-
4511-DR), dated April 1, 2020, and related determinations.

DATES: The declaration was issued April 1, 2020.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated April 1, 2020, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the emergency conditions in the
Commonwealth of the Northern Mariana Islands resulting from the
Coronavirus Disease 2019 (COVID-19) pandemic beginning on January
20, 2020, and continuing, are of sufficient severity and magnitude
to warrant a major disaster declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq.
(the ``Stafford Act''). Therefore, I declare that such a major
disaster exists in the Commonwealth of the Northern Mariana Islands.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide assistance for emergency
protective measures (Category B), including direct Federal
assistance, under the Public Assistance program throughout the
Commonwealth. Consistent with the requirement that Federal
assistance be supplemental, any Federal funds provided under the
Stafford Act for Public Assistance will be limited to 75 percent of
the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Robert J. Fenton, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the Commonwealth of the Northern Mariana
Islands have been designated as adversely affected by this major
disaster:

    Emergency protective measures (Category B) not authorized under
other Federal statutes, including direct Federal assistance, under
the Public Assistance program at 75 percent federal funding for all
islands in the Commonwealth of the Northern Mariana Islands.

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

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-09502 Filed 5-4-20; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 78, Number 45 (Thursday, March 7, 2013)]
[Rules and Regulations]
[Pages 14652-14653]
[FR Doc No: 2013-05209]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-1401; Airspace Docket No. 11-AGL-27]

Amendment of Class E Airspace; Gaylord, MI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace at Gaylord, MI. Additional
controlled airspace is necessary to accommodate new Area Navigation
(RNAV) Standard Instrument Approach Procedures at Gaylord Regional
Airport. The airport's name and geographic coordinates are also
adjusted. The FAA is taking this action to enhance the safety and
management of Instrument Flight Rule (IFR) operations at the airport.

DATES: Effective Date: 0901 UTC, June 27, 2013. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

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:

History

    On September 13, 2012, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to amend Class E airspace for the
Gaylord, MI, area, creating additional controlled airspace at Gaylord
Regional Airport (77 FR 56586) Docket No. FAA-2011-1401. Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal to the FAA. No comments
were received. Class E airspace designations are published in paragraph
6005 of FAA Order 7400.9W dated August 8, 2012, and effective September
15, 2012, which is incorporated by reference in 14 CFR 71.1. The Class
E airspace designations listed in this document will be published
subsequently in the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by amending Class E airspace extending upward from 700 feet
above the surface to ensure that required controlled airspace exists to
contain new standard instrument approach procedures at Gaylord Regional
Airport, Gaylord, MI. This action enhances the safety and management of
IFR operations at the airport. Geographic coordinates of the airport
are updated, as well as the airport name from Otsego County Airport to
Gaylord Regional Airport, to coincide with the FAA's aeronautical
database.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (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 amends
controlled airspace at Gaylord Regional Airport, Gaylord, MI.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9W, Airspace Designations and
Reporting Points, dated August 8, 2012, and effective September 15,
2012, is amended as follows:

Paragraph 6005: Class E airspace areas extending upward from 700
feet or more above the surface

* * * * *

AGL MI E5 Gaylord, MI [Amended]

Gaylord Regional Airport, MI
    (Lat. 45[deg]00'47'' N., long. 84[deg]42'12'' W.)
Gaylord VOR/DME
    (Lat. 45[deg]00'45'' N., long. 84[deg]42'15'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7-mile radius of Gaylord Regional Airport, and within 2
miles each side of the 090[deg] bearing from the airport extending
from the 7-mile radius to 10.5 miles east of the airport, and within
8 miles north and 4 miles south of the Gaylord VOR/DME 278[deg]
radial extending from the 7-mile radius to 14.1 miles west of the
airport, and within 8 miles north and 4 miles south of the Gaylord
VOR/DME 270[deg] radial extending from the 7-mile radius to 14.2
miles west of the airport.

    Issued in Fort Worth, Texas, on February 12, 2013.
David P. Medina,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2013-05209 Filed 3-6-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16196-16199]
[FR Doc No: 2022-06008]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1584]

Authorization of Emergency Use of Certain Medical Devices During
COVID-19; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the issuance of Emergency Use Authorizations (EUAs) (the
Authorizations) for certain medical devices related to the Coronavirus
Disease 2019 (COVID-19) public health emergency. FDA has issued the
Authorizations listed in this document under the Federal Food, Drug,
and Cosmetic Act (FD&C Act). These Authorizations contain, among other
things, conditions on the emergency use of the authorized products. The

Authorizations follow the February 4, 2020, determination by the
Secretary of Health and Human Services (HHS) that there is a public
health emergency that has a significant potential to affect national
security or the health and security of U.S. citizens living abroad and
that involves the virus that causes COVID-19, and the subsequent
declarations on February 4, 2020, March 2, 2020, and March 24, 2020,
that circumstances exist justifying the authorization of emergency use
of in vitro diagnostics for detection and/or diagnosis of the virus
that causes COVID-19, personal respiratory protective devices, and
medical devices, including alternative products used as medical
devices, respectively, subject to the terms of any authorization issued
under the FD&C Act. These Authorizations, which include an explanation
of the reasons for issuance, are listed in this document, and can be
accessed on FDA's website from the links indicated.

DATES: These Authorizations are effective on their date of issuance.

ADDRESSES: Submit written requests for single copies of an EUA to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the Authorization may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen the public health protections against biological, chemical,
radiological, or nuclear agent or agents. Among other things, section
564 of the FD&C Act allows FDA to authorize the use of an unapproved
medical product or an unapproved use of an approved medical product in
certain situations. With this EUA authority, FDA can help ensure that
medical countermeasures may be used in emergencies to diagnose, treat,
or prevent serious or life-threatening diseases or conditions caused by
a biological, chemical, radiological, or nuclear agent or agents when
there are no adequate, approved, and available alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
A determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces, including personnel operating under the
authority of title 10 or title 50 of the U.S. Code, of attack with (A)
a biological, chemical, radiological, or nuclear agent or agents; or
(B) an agent or agents that may cause, or are otherwise associated
with, an imminently life-threatening and specific risk to U.S. military
forces; \1\ (3) a determination by the Secretary of HHS that there is a
public health emergency, or a significant potential for a public health
emergency, that affects, or has a significant potential to affect,
national security or the health and security of U.S. citizens living
abroad, and that involves a biological, chemical, radiological, or
nuclear agent or agents, or a disease or condition that may be
attributable to such agent or agents; or (4) the identification of a
material threat by the Secretary of Homeland Security pursuant to
section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-
6b) sufficient to affect national security or the health and security
of U.S. citizens living abroad.
---------------------------------------------------------------------------

    \1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine within 45 calendar days of such
determination, whether to make a declaration under section 564(b)(1)
of the FD&C Act, and, if appropriate, shall promptly make such a
declaration.
---------------------------------------------------------------------------

    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Under section 564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available on the internet website of
FDA. Section 564 of the FD&C Act permits FDA to authorize the
introduction into interstate commerce of a drug, device, or biological
product intended for use when the Secretary of HHS has declared that
circumstances exist justifying the authorization of emergency use.
Products appropriate for emergency use may include products and uses
that are not approved, cleared, or licensed under section 505, 510(k),
512, or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 360b, or 360e) or
section 351 of the PHS Act (42 U.S.C. 262), or conditionally approved
under section 571 of the FD&C Act (21 U.S.C. 360ccc). FDA may issue an
EUA only if, after consultation with the HHS Assistant Secretary for
Preparedness and Response, the Director of the National Institutes of
Health, and the Director of the Centers for Disease Control and
Prevention (to the extent feasible and appropriate given the applicable
circumstances), FDA \2\ concludes: (1) That an agent referred to in a
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of
scientific evidence available to FDA, including data from adequate and
well-controlled clinical trials, if available, it is reasonable to
believe that (A) the product may be effective in diagnosing, treating,
or preventing (i) such disease or condition; or (ii) a serious or life-
threatening disease or condition caused by a product authorized under
section 564, approved or cleared under the FD&C Act, or licensed under
section 351 of the PHS Act, for diagnosing, treating, or preventing
such a disease or condition caused by such an agent; and (B) the known
and potential benefits of the product, when used to diagnose, prevent,
or treat such disease or condition, outweigh the known and potential
risks of the product, taking into consideration the material threat
posed by the agent or agents identified in a declaration under section
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no
adequate, approved, and available alternative to the product for
diagnosing, preventing, or treating such disease or condition; (4) in
the case of a determination described in section 564(b)(1)(B)(ii), that
the request for emergency use is made by the Secretary of Defense; and
(5) that such other criteria as may be prescribed by regulation are
satisfied. No other criteria for issuance have been

prescribed by regulation under section 564(c)(4) of the FD&C Act.
---------------------------------------------------------------------------

    \2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------

II. Electronic Access

    An electronic version of this document and the full text of the
Authorizations are available on the internet and can be accessed from
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

III. The Authorizations

    Having concluded that the criteria for the issuance of the
following Authorizations under section 564(c) of the FD&C Act are met,
FDA has authorized the emergency use of the following products for
diagnosing, treating, or preventing COVID-19 subject to the terms of
each Authorization. The Authorizations in their entirety, including any
authorized fact sheets and other written materials, can be accessed
from the FDA web page entitled ``Emergency Use Authorization,''
available at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
The lists that follow include Authorizations issued from September 11,
2021, through January 24, 2022, and we have included explanations of
the reasons for their issuance, as required by section 564(h)(1) of the
FD&C Act. In addition, the EUAs that have been reissued can be accessed
from FDA's web page: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
    FDA is hereby announcing the following Authorizations for molecular
diagnostic and antigen tests for COVID-19, excluding multianalyte
tests: \3\
---------------------------------------------------------------------------

    \3\ As set forth in the EUAs for these products, FDA has
concluded that: (1) SARS-CoV-2, the virus that causes COVID-19, can
cause a serious or life-threatening disease or condition, including
severe respiratory illness, to humans infected by this virus; (2)
based on the totality of scientific evidence available to FDA, it is
reasonable to believe that the products may be effective in
diagnosing COVID-19, and that the known and potential benefits of
the products, when used for diagnosing COVID-19, outweigh the known
and potential risks of such products; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
products.
---------------------------------------------------------------------------

     Life Sciences Testing Center's Life Sciences Testing
Center COVID-19 Test, issued September 22, 2021;
     ANP Technologies, Inc.'s NIDS COVID-19 Antigen Rapid Test
Kit, issued September 24, 2021;
     Cleveland Clinic Robert J. Tomsich Pathology and
Laboratory Medicine Institute's SelfCheck cobas SARS-CoV-2 Assay,
issued September 29, 2021;
     ACON Laboratories, Inc.'s Flowflex COVID-19 Antigen Home
Test, issued October 4, 2021;
     Xtrava Health's SPERA COVID-19 Ag Test, issued October 12,
2021;
     LMSI, LLC's (d/b/a Lighthouse Lab Services) CovidNow SARS-
CoV-2 Assay, issued October 14, 2021;
     Celltrion USA, Inc.'s Celltrion DiaTrust COVID-19 Ag Home
Test, issued October 21, 2021;
     Detect, Inc's Detect Covid-19 Test, issued October 28,
2021;
     Talis Biomedical Corporation's Talis One COVID-19 Test
System, issued November 5, 2021;
     iHealth Labs, Inc.'s iHealth COVID-19 Antigen Rapid Test,
issued November 5, 2021;
     Meridian Bioscience, Inc.'s Revogene SARS-CoV-2, issued
November 9, 2021;
     InBios International Inc.'s SCoV-2 Ag Detect Rapid Self-
Test, issued November 22, 2021;
     Nano-Ditech Corp.'s Nano-Check COVID-19 Antigen Test,
issued December 6, 2021;
     UCSD BCG EXCITE Lab's UCSD EXCITE COVID-19 Test, issued
December 17, 2021;
     SD Biosensor, Inc.'s COVID-19 At-Home Test, issued
December 24, 2021;
     Siemens Healthineers' CLINITEST Rapid COVID-19 Antigen
Self-Test, issued December 29, 2021;
     Premier Medical Laboratory Services' PMLS SARS-CoV-2
Assay, issued January 7, 2022;
     iHealth Labs, Inc.'s iHealth COVID-19 Antigen Rapid Test
Pro, issued January 14, 2022;
     Maxim Biomedical, Inc.'s MaximBio ClearDetect COVID-19
Antigen Home Test, issued January 19, 2022; and
     Mammoth Biosciences, Inc.'s DETECTR BOOST SARS-CoV-2
Reagent Kit, issued January 21, 2022.
    FDA is hereby announcing the following Authorizations for serology
tests: \4\
---------------------------------------------------------------------------

    \4\ As set forth in the EUAs for these products, FDA has
concluded that: (1) SARS-CoV-2 can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the products may be effective in diagnosing recent or prior
infection with SARS-CoV-2 by identifying individuals with an
adaptive immune response to the virus that causes COVID-19, and that
the known and potential benefits of the products when used for such
use, outweigh the known and potential risks of the products; and (3)
there is no adequate, approved, and available alternative to the
emergency use of the products.
---------------------------------------------------------------------------

     EUROIMMUN US, Inc.'s EUROIMMUN Anti-SARS-CoV-2 S1 Curve
ELISA (IgG), issued October 4, 2021;
     InBios International, Inc.'s SCoV-2 Detect Neutralizing Ab
ELISA, issued October 22, 2021.
    FDA is hereby announcing the following Authorizations for
multianalyte in vitro diagnostics:
     Laboratory Corporation of America's Labcorp SARS-CoV-2 &
Influenza A/B Assay, issued September 30, 2021; \5\
---------------------------------------------------------------------------

    \5\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing COVID-19 through the simultaneous qualitative
detection and differentiation of SARS-CoV-2, influenza A virus, and/
or influenza B virus RNA and that the known and potential benefits
of the product when used for diagnosing COVID-19, outweigh the known
and potential risks of the product; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
product.
---------------------------------------------------------------------------

     PerkinElmer, Inc.'s PKamp Respiratory SARS-CoV-2 RT-PCR
Panel 1, issued October 6, 2021; \6\ and
---------------------------------------------------------------------------

    \6\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing COVID-19, through the simultaneous qualitative
detection and differentiation of SARS-CoV-2, influenza A, influenza
B, and/or RSV virus RNA, and that the known and potential benefits
of the product when used for diagnosing COVID-19, outweigh the known
and potential risks of the product; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
product.
---------------------------------------------------------------------------

     Applied BioCode, Inc.'s BioCode CoV-2 Flu Plus Assay,
issued December 15, 2021 \7\ FDA is hereby announcing the following
Authorizations for other medical devices:
---------------------------------------------------------------------------

    \7\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing COVID-19, through the simultaneous qualitative
detection and differentiation of RNA from SARS-CoV-2, influenza A
virus, influenza B virus, and/or RSV, and that the known and
potential benefits of your product when used for diagnosing COVID-
19, outweigh the known and potential risks of your product; and (3)
there is no adequate, approved, and available alternative to the
emergency use of the product.
---------------------------------------------------------------------------

     Quest Diagnostics Infectious Disease, Inc.'s Quest
Diagnostics Collection Kit for COVID-19, issued October 8, 2021; \8\
---------------------------------------------------------------------------

    \8\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing COVID-19 by serving as an appropriate means to collect
and transport human specimens so that an authorized laboratory can
detect SARS-CoV-2 RNA from the collected human specimen, and that
the known and potential benefits of the product when used for such
use, outweigh the known and potential risks of the product; and (3)
there is no adequate, approved, and available alternative to the
emergency use of the product.

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

     Audere's [email protected], issued November 30, 2021; \9\
---------------------------------------------------------------------------

    \9\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing COVID-19 by serving as an appropriate means to collect
and transport human specimens so that an authorized laboratory can
detect SARS-CoV-2 RNA from the collected human specimen, and that
the known and potential benefits of the product when used for such
use, outweigh the known and potential risks of the product; and (3)
there is no adequate, approved, and available alternative to the
emergency use of the product.
---------------------------------------------------------------------------

    In addition, on September 23, 2021, FDA issued a letter to
Developers of Certain Molecular, Antigen and Serology In Vitro
Diagnostics (IVDs) Authorized for Emergency Use for Coronavirus Disease
2019 (COVID-19) as of Today's Date (September 23, 2021) for
Establishing additional Conditions of Authorization for the EUAs of
Certain Molecular, Antigen and Serology IVDs related to viral
mutations.\10\
---------------------------------------------------------------------------

    \10\ FDA concluded that establishing additional conditions on
the EUAs within the scope of the letter is appropriate to protect
the public health or safety and revised all such EUAs pursuant to
Section 564(g)(2)(C) of the FD&C Act to establish the three
additional conditions set forth in the letter as permitted by
Section 564(e) of the FD&C Act.

    Dated: March 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-06008 Filed 3-21-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 170 (Tuesday, September 3, 2019)]
[Notices]
[Page 46005]
[FR Doc No: 2019-18923]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. NJ19-16-000]

Hoosier Energy Rural Electric Cooperative; Notice of Filing

    Take notice that on August 21, 2019, the Hoosier Energy Rural
Electric Cooperative submitted its tariff filing: Specification of
Cost-Based Revenue Requirement to be effective August 21, 2019.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the website that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on September 11, 2019.

    Dated: August 27, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-18923 Filed 8-30-19; 8:45 am]
 BILLING CODE 6717-01-P


MEMORANDUM

TO:	Brian D’Amico and Eric Strassler, EPA/EAD

FROM:	Steve Strackbein and Mary Willett, ERG

DATE:	June 29, 2009

SUBJECT:	Washington Dulles Runway 1L-19R Construction Project Details
and Update

Project Details

The Metropolitan Washington Airports Authority (MWAA) has recently
constructed a fourth runway (Runway 1L-19R), associated taxiways, and an
approximately 30-acre deicing pad at Washington Dulles International
Airport (IAD).  The stormwater management system for the runway was
designed to detain stormwater for treatment through constructed wetland
Biological Treatment Units (BTUs).

Table 1 presents design specifications, costs, and material/construction
information identified for the runway project.

Table 1. Dulles Airport New Runway Design Specifications, Costs, and
Material/Construction Information.

Item	Description	Comments

Runway Length	9,400 feet

	Runway Width	150 feet

	Connector Taxiways	75 feet wide by

 3,100 feet long	Runway includes three (3) connector taxiways

Deicing Pad	700 feet x 1,870 feet	Capital costs not provided by MWAA

Project Cost	$356 million	Included $200 million in AIP funding

Clearing and Grubbing	675 acres

	Topsoil Stripping	525,000 cubic yards

	Excavation	2,300,000 cubic yards

	Cement Treated Base	883,655 square yards

	Concrete	610,000 square yards

	Asphalt Pavement	340,686 square yards	Equivalent to 24.2 miles of road

Underground Copper Cable	742,610 feet	Equivalent to 140 miles of cable

Drainage Pipe	22,051 feet	Equivalent to 4.17 miles of pipe

Reinforced Concrete Pipe	15,300 feet

	Box Culverts	13	Combined 4,700 linear feet

Fencing	22,000 linear feet

	Labor – Earthwork	500,000 man hours

	Labor – Paving	1,000,000 man hours

The project also included a $1.5 million investment for five new
constructed wetland BTU’s placed adjacent to the runway to provide a
cleansing effect to stormwater runoff in the area.  This treatment
technology utilizes a complex system of collection and distribution
pipes. This design allows even distribution of runoff to maximize
effective treatment across each unit before being discharged.

Each BTU incorporates multiple layers of sand, stone and a special soil
mixture, topped with specific surface vegetation including cattails and
other plant species native to the mid-Atlantic region.  The vegetation
was selected for its tolerance to flooding, extensive root depth,
oxygen-carrying capacity of the root system, and poor wildlife habitat.
Contaminated stormwater is piped to the BTU where contaminants are
absorbed by the plants’ root system, broken down by soil
microorganisms, or physically filtered by the media comprising each
layer.  The BTUs can be bypassed during clean stormwater flows.

Expected Performance for the BTUs

For IAD, fugitive glycol losses will now be more effectively managed by
diversion to the constructed wetlands for BTU treatment and discharge.

The two primary functions of the BTUs are to treat storm water runoff
that contains fugitive deicing fluids that occur outside the contained
centralized deicing areas and to remove total phosphorous from storm
water runoff.  Additional benefits to the environment will be a
reduction in the amount of BOD discharged to local streams.  The BTUs
are expected to produce effluent BOD concentrations of 100 mg/L and a
50% reduction in phosphorus discharges.  The BTUs work by degrading the
dissolved organic matter through microbial growth and respiration.  BTUs
have the capability of metabolizing toxic organic compounds and
degrading other stormwater contaminants including oil and grease,
suspended solids, and nutrients.  Table 2 presents the expected removal
efficiencies and effluent concentrations for the constructed wetland
BTUs at IAD.

Table 2. Expected BTU Removal Efficiency and Effluent Concentrations

Parameter	Removal Efficiency	Effluent Concentration

BOD	50 - 90%	2 – 100 mg/L

TSS	50 - 90%	2 – 10 mg/L

TN	40 - 90%	1 – 3 mg/L

TP	10 - 90%	<1 mg/L

Fecal Coliforms	80 - 99%	<100 – 1,000 col/100mL

Metals	50 - 90%	Below Detection

*Removal efficiencies and effluent concentrations are very dependent
upon influent concentration and hydraulic loading rate.

BOD – Biochemical Oxygen Demand

TSS – Total Suspended Solids

TN – Total Nitrogen

TP – Total Phosphorus

Current Status

Based on a June 11, 2009 call with Mr. Thomas Beatty of MWAA, the
constructed wetland BTUs are in place and going through start up.  Mr.
Beatty indicated that no performance data is yet available for the
units.

 PAGE

 PAGE   3


[Federal Register: March 27, 2009 (Volume 74, Number 58)]
[Notices]
[Page 13501-13503]
[DOCID:fr27mr09-101]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59614; File No. SR-NYSEALTR-2009-27]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by NYSE Alternext U.S. LLC
Amending NYSE Alternext Equities Rule 124 To Execute the Odd-Lot
Portion of a Part of a Round-Lot Order Pursuant to the Same Pricing
Methodology Used for Odd-Lot Orders

March 20, 2009.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on March 11, 2009, NYSE Alternext U.S. LLC (the
``Exchange'' or ``NYSE Alternext'') filed with the Securities and
Exchange Commission (the ``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\ 15 U.S.C. 78a.
    \3\ 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 amend NYSE Alternext Equities Rule 124
(Odd-Lot Orders) to execute the odd-lot portion of a part of a round-
lot (``PRL'') order pursuant to the same pricing methodology used for
odd-lot orders.

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 those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    Through this filing the Exchange seeks to amend NYSE Alternext
Equities Rule 124 (Odd-Lot Orders) to execute the odd-lot portion of a
part of a round-lot (``PRL'') order pursuant to the same pricing
methodology used for odd-lot orders.\4\
---------------------------------------------------------------------------

    \4\ PRL orders are for a size within the standard unit (round-
lot) of trading, which is 100 shares for most stocks, but contains a
portion that is smaller than the standard unit of trading, e.g. 199
shares. It should be noted that for certain securities trading on
the NYSE Alternext Trading Systems the standard unit of trading is
10 shares.
---------------------------------------------------------------------------

    These amendments are proposed to conform to amendments filed by the
New York Stock Exchange (``NYSE'').\5\
---------------------------------------------------------------------------

    \5\ See SR-NYSE-2009-27 (to be filed March 11, 2009).
---------------------------------------------------------------------------

Background
    As described more fully in a related rule filing,\6\ NYSE Euronext
acquired The Amex Membership Corporation (``AMC'') pursuant to an
Agreement and Plan of Merger, dated January 17, 2008 (the ``Merger'').
In connection with the Merger, the Exchange's predecessor, the American
Stock Exchange LLC (``Amex''), a subsidiary of AMC, became a subsidiary
of NYSE Euronext called NYSE Alternext U.S. LLC, and continues to
operate as a national securities exchange registered under Section 6 of
the Securities Exchange Act of 1934, as amended (the ``Act'').\7\ The
effective date of the Merger was October 1, 2008.
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 58673 (September 29,
2008), 73 FR 57707 (October 3, 2008) (SR-NYSE-2008-60 and SR-Amex
2008-62) (approving the Merger).
    \7\ 15 U.S.C. 78f.
---------------------------------------------------------------------------

    In connection with the Merger, on December 1, 2008, the Exchange
relocated all equities trading conducted on the Exchange legacy trading
systems and facilities located at 86 Trinity Place, New York, New York
(the ``86 Trinity Trading Systems''), to trading systems and facilities
located at 11 Wall Street, New York, New York (the ``Equities
Relocation''). The Exchange's equity trading systems and facilities at
11 Wall Street (the ``NYSE Alternext Trading Systems'') are operated by
the NYSE on behalf of the Exchange.\8\
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 58705 (October 1,
2008), 73 FR 58995 (October 8, 2008) (SR-Amex 2008-63) (approving
the Equities Relocation).
---------------------------------------------------------------------------

    In order to implement the Equities Relocation, the Exchange adopted
Rules 1-1004 of the New York Stock Exchange LLC as the NYSE Alternext
Equities Rules to govern the equities trading on the NYSE Alternext
Trading Systems.
Current Execution of Odd-Lot Orders
    Currently, odd-lot orders on the Exchange are processed in a
separate system on the Exchange from the Exchange systems that execute
round-lot orders. Odd-lots are executed systemically by Exchange
systems designated solely for odd-lot orders (the ``Odd-lot
System'').\9\ The odd-lot System executes all odd-lot orders against
the DMM as the contra party.\10\
---------------------------------------------------------------------------

    \9\ See NYSE Alternext Equities Rule 124(a).
    \10\ Id. Odd-lot orders are in effect netted against one another
and executed; however, since the DMM is buying the same amount that
he or she is selling, there is no economic consequence to the DMM in
this type of pairing-off of orders. Any imbalance of buy or sell
odd-lot market orders are executed against the DMM, up to the size
of the round-lot transaction or the BID/OFFER size which ever is
less.
---------------------------------------------------------------------------

    Pursuant to NYSE Alternext Equities Rule 124(c), after odd-lot
market orders and marketable odd-lot limit orders are received by the
Odd-lot System, they are automatically executed at the price of the
next round-lot transaction in the subject security on the Exchange.
Specifically, marketable odd-lot orders and marketable odd-lot limit
orders are executed in time priority of receipt at the price of the
next round-lot transaction, pursuant to the net process described in
footnote 14 [sic]. The imbalance of marketable odd-lot orders that do
not receive an execution as a result of the netting provision are
executed in time priority of receipt at the price of the NBBO, subject
to a volume limitation.\11\ Any imbalances of odd-lot limit orders that
were non-marketable upon receipt that subsequently become marketable
receive an execution at their limit price.\12\ Marketable odd-lot
orders which would otherwise receive a partial

execution pursuant to the volume limitation are executed in full.\13\
---------------------------------------------------------------------------

    \11\ The volume limitation in section (c) of the rule is defined
as the lesser of either the number of shares in the last round-lot
transaction or the number of shares available at the national best
bid (in the case of an odd-lot order to sell), or the national best
offer (in the case of an odd-lot order to buy).
    \12\ Pursuant to NYSE Alternext Equities Rule 124(d) odd-lot
limit orders that are non-marketable upon receipt that become
marketable are eligible to be netted and executed at the price of
the next round-lot transaction. If odd-lot limit orders do not
receive an execution pursuant to the netting provision, then the
orders are eligible to be executed, at its limit price, subject to
the volume limitation of section (c) of the rule.
    \13\ As with marketable odd-lot orders, non-marketable odd-lot
limit orders which would otherwise receive a partial execution will
be executed in full. Non-marketable odd-lot limit orders that become
marketable, that remain unexecuted within 30 seconds of receipt will
be executed, in time priority of receipt, except that the orders
will be executed at its limit price.
---------------------------------------------------------------------------

    Any marketable odd-lot orders that do not receive an execution
because of the volume limitation are executed, in time priority of
receipt at the price of the next round-lot transaction, following
pricing and execution procedures described above. Marketable odd-lot
orders (including odd-lot limit orders that were non-marketable upon
receipt and subsequently become marketable) that remain unexecuted
within 30 seconds of receipt will be executed, in time priority of
receipt, at the price of the NBBO (or at its limit price if the order
is a non-marketable odd-lot limit order upon receipt that has become
marketable). These orders are also subject to the volume limitation.
    Marketable odd-lot orders and non-marketable odd-lot limit orders
that have become marketable and remain unexecuted prior to the close of
trading shall be executed, in time priority of receipt at the price of
the closing transaction, subject to the netting provision and a volume
restriction which is not to exceed the size of the closing transaction.
    The round-lot portion of a PRL is executed in the Exchange's round-
lot system and the odd-lot portion is executed in the Odd-lot System
only if no round-lot portion of the initial PRL order is cancelled.\14\
Where more than one round-lot transaction is required to effect the
complete execution of the round-lot portion of a PRL, the odd lot
portion is executed only if the entire round-lot portion(s) of the PRL
order as received by the Exchange is executed. Thereafter, the odd-lot
portion is executed at the same price as the last round-lot transaction
that is needed to completely execute all round-lot portions of the PRL.
---------------------------------------------------------------------------

    \14\ See NYSE Alternext Equities Rule 124.40.
---------------------------------------------------------------------------

Example
    An order to sell 399 shares of security XYZ is received by Exchange
systems at 12:00:00. The 99 share portion of the order is eligible for
execution only after the 300 share portion of the PRL order is sold.
See table below.

----------------------------------------------------------------------------------------------------------------
         Time of execution              Number of shares       Price of execution         Customer receives
----------------------------------------------------------------------------------------------------------------
12:00:01...........................  100...................  $30.22................  Report of Execution 100
                                                                                shares at a price of
                                                                                $30.22.
12:01:00...........................  100...................  $30.21................  Report of Execution 100
                                                                                shares at a price of
                                                                                $30.22.
12:01:47...........................  100...................  $30.22................  Report of Execution 199
12:01:47...........................  99....................  $30.22................   shares at a price of
                                                                                $30.22.
----------------------------------------------------------------------------------------------------------------

Proposed Amendment to Partial Round Lot Pricing
    As explained above, NYSE Alternext Trading Systems are operated by
the NYSE on behalf of the Exchange. Legacy systems operated by the NYSE
that were responsible for sequencing order execution were unable to
handle the number of variables necessary to track the odd-lot portion
of a PRL order in the event a customer sought to cancel or replace his
or her PRL. This systemic impediment required the Exchange to handle
the execution of the odd-lot portion of a PRL differently from other
odd-lot orders to ensure that customers were able to efficiently
execute their PRL orders and receive timely information about the
orders' status. Today, significant upgrades to the technology now make
it possible for Exchange systems to price all odd-lot orders consistent
with the provisions NYSE Alternext Equities 124(c) and (d).
    The Exchange therefore proposes to amend NYSE Alternext Equities
124.40 to allow the odd-lot portion of PRLs to be executed in the Odd-
lot System pursuant to the pricing provisions of NYSE Alternext
Equities 124. The Exchange will continue to execute the odd-lot
component of a PRL only if the entire round-lot portion(s) of the order
as received by Exchange system is executed. The odd-lot portion of the
PRL will retain the time stamp of its original entry as a PRL and would
be sequenced for execution based on its initial entry time. Once all
round lot components of the PRL are fully executed, the odd-lot portion
of the order will be executed at a price consistent with other odd-lot
orders subject to the provisions of NYSE Alternext Equities Rule 124(c)
and (d).
Example
    A marketable order to sell 399 shares of security XYZ is received
by Exchange systems at 12:00:00. The 99 share portion of the order is
eligible for execution only after the 300 share portion of the PRL
order is sold. See table below.

----------------------------------------------------------------------------------------------------------------
         Time of execution              Number of shares       Price of execution         Customer receives
----------------------------------------------------------------------------------------------------------------
12:00:01...........................  100...................  $30.22................  Report of Execution 100
                                                                                shares at a price of
                                                                                $30.22.
12:01:00...........................  100...................  30.21.................  Report of Execution 100
                                                                                shares at a price of
                                                                                $30.21.
12:01:47...........................  100...................  30.22.................  Report of Execution 100
                                                                                shares at a price of
                                                                                $30.22.
12:01:48...........................  99....................  \15\ 30.23............  Report of Execution 99
                                                                                shares at a price of
                                                                                $30.23.
----------------------------------------------------------------------------------------------------------------

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

    \15\ This example assumes that the odd-lot portion of the PRL
had priority of execution in the Odd-lot system because its original
order entry time was 12:00:00.
---------------------------------------------------------------------------

    The Exchange proposed amendment to NYSE Alternext Equities 124.40,
will ensure that all odd-lots executed on the Exchange receive
consistent pricing regardless of whether the order is received as an
odd-lot order or a PRL.
    The Exchange will commence implementation of the proposed systemic
change to execute the odd-lot portion of a PRL order pursuant to the
same pricing methodology used for odd-lot orders on or about March 16,
2009. The Exchange intends to progressively implement this systemic
change for PRLs on a security by security basis as it gains experience
with the new technology until it is operative in all securities traded
on the Floor. During the implementation, the Exchange will identify on
its Web site which securities have been transitioned to the new system.

2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under Section 6(b)(5) \16\ that an Exchange have rules that
are 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. The instant proposal is in keeping
with these principles in that it seeks to price the execution of all
odd-lot orders pursuant to one pricing methodology now that the
Exchange systemic impediments to the implementation of one pricing
methodology are removed.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

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

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

    The proposed rule change is filed pursuant to paragraph (A) of
Section 19(b)(3) \17\ and Rule 19b-4(f)(5).\18\ This proposed rule
change effects a change in an existing order entry or trading system of
a self-regulatory organization that: (A) Does not significantly affect
the protection of investors or the public interest; (B) does not impose
any significant burden on competition; and (C) does not have the effect
of limiting the access to or availability of the system. The proposed
filing does not in any way limit access to the Exchange's odd-lot
system; rather, the changes are the result of technological
advancements which remove the systemic impediments that previously
restricted the Exchange's ability to execute all odd-lots pursuant to a
the same pricing methodology. In so far as, the proposal ensures that
all odd-lot orders are priced in the same manner, it promotes the
protection of investors and serves the public interest without imposing
a significant burden on competition.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(3)(A).
    \18\ 17 CFR 240.19b-4(f)(5).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEALTR-2009-27 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-NYSEALTR-2009-27. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 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-NYSEALTR-2009-27 and should
be submitted on or before April 17, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-6829 Filed 3-26-09; 8:45 am]