[Federal Register: February 7, 2008 (Volume 73, Number 26)]
[Notices]
[Page 7338-7339]
[DOCID:fr07fe08-102]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57256; File No. SR-CBOE-2008-09]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing of Proposed Rule Change Establishing a
Voluntary Professional Designation

February 1, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 \2\ thereunder, notice is hereby given
that on January 18, 2008, the Chicago Board Options Exchange,
Incorporated (the ``Exchange'' or ``CBOE'') filed with the Securities
and Exchange Commission (``Commission'') the proposed rule change as
described in Items I, II, and III below, which Items have been
substantially prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

     The Exchange proposes to adopt a voluntary professional
designation. The text of the proposed rule change is available at CBOE,
the Commission's Public Reference Room, and (http://www.cboe.org/Legal
).

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

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

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

1. Purpose
     This filing proposes to allow non-broker-dealer customers to
voluntarily have their orders categorized as broker-dealer orders for
order handling, order execution, and cancel fee calculation purposes
(``Voluntary Professional(s)''). Specifically, these orders would be
treated as broker-dealer orders for purposes of CBOE Rules 6.13 (CBOE
Hybrid System's Automatic Execution Feature), 6.45 (Priority of Bids
and Offers--Allocation of Trades), 6.45A (Priority and Allocation of
Equity Option Trades on the CBOE Hybrid System), 6.45B (Priority and
Allocation of Trades in Index Options and Options on ETFs on the CBOE
Hybrid System), and 6.53C (Complex Orders on the Hybrid System).
    Some Exchange users have requested this flexibility because it is
more suitable to their trading strategies that involve high volume
order submission and cancellation. These Voluntary Professionals would
participate on trades on the same terms as broker-dealer orders for
purposes of the rules set forth above. Orders from Voluntary
Professionals would continue to be treated as public customer orders
for purposes of the linkage-related rules. CBOE would provide the same
away-market protection for orders from Voluntary Professionals as for
orders from public customers. Additionally, orders from Voluntary
Professionals that are cancelled would not be counted as public
customer order cancellations in connection with the cancellation fee
calculation applicable to clearing members. The Exchange intends to
establish, via a separate rule filing under Section 19(b) of the Act, a
transaction fee applicable to Voluntary Professionals and the Exchange
would not commence the Voluntary Professional program until such fee
was in place.
2. Statutory Basis
     The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\3\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\4\ in particular, in that it
is designed to promote just and equitable principles of trade, serve to
remove impediments to and perfect the mechanism of a free and open
market and a national market system, and protect investors and the
public interest.
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    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

     CBOE 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

     Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve such proposed rule change or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
) or send an e-mail to<EMAIL_ADDRESS>Please include File Number SR-CBOE-2008-09 on the

subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2008-09. 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 at (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 such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-CBOE-2008-09 and should be
submitted on or before February 28, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\5\
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    \5\ 17 CFR 200.30-3(a)(12).
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 Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-2266 Filed 2-6-08; 8:45 am]

BILLING CODE 8011-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY OFFICE OF AIR QUALITY PLANNING AND STANDARDS EMISSION STANDARDS DIVISION RESEARCH TRIANGLE PARK, NC 27711 August 12, 2003 SUBJECT: Use of Metallic Cobalt in Magnetic Tape Manufacturing Process at Sony Magnetic Products Inc., Dothan, Alabama FROM: H. Lynn Dail, Project Lead Coatings and Consumer Products Group ( C539 03)

TO: Docket No. A 91 31, Magnetic Tape Manufacturing Operations E Docket OAR 2003 0161 Sony Magnetics Products Inc. of America, located in Dothan, Alabama, produces a specialized magnetic tape. This tape, an Advanced Metal Evaporative ( AME) media incorporates pure cobalt metallization to produce their trademarked Advanced Intelligence Tape ( AIT). The tape is used as a computer back up storage tape capable of storing 150 Gigabytes on an 8 mm cassette.

The magnetic recording layer of AME media contains pure evaporated cobalt and is deposited on the tape under vacuum. When an electron bean is introduced into a mass of metallic cobalt, the metal essentially melts into a liquid that is magnetized and allows the cobalt to " stick" to the tape as a surface coating. During the process, no metallic cobalt dust or vapor emissions are occurring.

The deposition of the cobalt onto the tape in this process is inefficient. Approximately 10% cobalt vapor sticks to tape and the remaining amount is deposited into the vacuum chamber. The accumulation in the vacuum chamber can be recovered and recycled. Therefore, a cleaning procedure is implemented to recover the remaining cobalt slag and dust when the process is shut down. The cleaning process, however, does not recover all unused cobalt.

Cleaning the equipment is a health hazard to employees unless OSHA guidelines for personnel protection and safety are followed. The cobalt must be removed from all parts of the machine. The employees don protective gear, enter the production area and initiate a cleaning process.

The opportunity for metallic cobalt emissions occur during the cleaning process. However, emissions mainly consist of particulate cobalt instead of vapor. The emission potential is very low and the possibility only occurs during the cleaning process. There are three pieces of production equipment that require cleaning. The largest portion of the equipment opens up like a " clam shell" to allow access for cleaning. The two large halves are cleaned in place in the production area. One particular removable component of the equipment is disassembled from the 2 line, and moved into a cleaning booth. The cleaning booth, of which Sony operates two, is constructed with a bag house.

Sony reports that most of the cobalt accumulation occurs during cleaning and is metallic cobalt slag adhered to machinery or small amounts of dust deposited on the floor, walls and equipment. Any airborne particles are captured by the bag house. Tests conducted by Sony indicate that the respirable particulate matter, particles smaller than 5 microns in size, comprises about 5 to 15% of the mass. The remaining 85 to 95% of cobalt is a heavy metal and essentially settles onto the floor within a reported 15 foot radius around the equipment as cleaning is underway. Sony's in house testing shows that beyond 15 feet, no cobalt has been detected. Sony has conducted other particle detection tests and found no cobalt emissions outside the buildings where the process equipment is installed.

The Alabama Department of Environmental Management ( ADEM) permits Sony to emit 9 tons per year ( tpy) or metallic cobalt. It has been the practice for Sony to report lost inventory as emissions. The EPA 2000 Toxic Release Inventory ( TRI) data showed 1555 pounds per year, presumed to be a combination of inventory loss and possible emissions. The ADEM provided EPA, Sony's inventory reports for a period covering 4/ 2002 to 4/ 2003. The reports indicated a 2.1 tpy inventory loss.

It is apparent that using a value that incorporates inventory loss with possible emissions may artificially elevate the emissions and result in a false indication of a risk. It became imperative to test the perceived cobalt emission stream to determine if any cobalt could be lost to processes other than emissions, thus reducing the overall reported cobalt emissions.

Inventory records for 2003 indicated a 2.1 ton loss of Co inventory. Upon testing of four major components associated with the magnetic tape production process using Co, Sony's testing has accounted for 1.4 tons per year of Co not lost through emissions, yet accounted as solid waste. The emission amount of 0.7 tpy is more representative of true emission amounts. Sony confirms through its data that nearly 60 to 75% of it's cobalt inventory loss, reported as emissions, is actually lost in the waste streams other than airborne emissions. That indicates that 1.40 tpy of Co is accounted for in the metallic slag, unrecovered slag, baghouse dust, floor ventilation filters and possibly wash water and protective gear decontamination wash water waste. With Sony's confirmation of this activity, we are able to refine and reduce the emissions quantities of cobalt from what has been reported in the 2000 TRI, down to a level, 0.175 tons/ year, that has resulted in a hazard index for this site that is well below EPA's threshold.

Testing has confirmed there were four areas where amounts of Co accumulated as either metallic slag or dust and where not emitted. The first areas tested were 2 bag houses where 200 lbs Co/ house was found. Next, testing involving the in floor ventilation openings produced an accumulation of 50 lbs Co/ year. The lion's share of Co loss has been discovered as a metallic slag of solid Co, adhered to metallic splash protectors that were a part of production equipment. These splash protectors are used and disposed of as solid waste with the Co metallic slag. Sony's current estimates indicate the majority of Co loss is at this point. The final area where Co was 3 accounted for as other than emissions, was the cleaning areas. When the equipment is cleaned, molten Co, accumulated on equipment and during production, releases from the equipment as solid chunks or flakes and thus becomes solid waste. These fallen chunks and flakes collect under the structure supporting the production equipment, used in the cleaning process. The Co flakes " pile up" until removed. As a side note, the cleaning wash water was tested to have less than 10 lbs Co/ year accumulation and this was determined insignificant factor in delineating Co emissions/ inventory loss.

Sony's Environmental Engineer is preparing the final written report to be sent to me by Monday, August 18, 2003. The bottom line that I am reporting to you is the following facts:

1. Sony's Co emissions have been analyzed and better Co loss tracking indicates that emission numbers about 66% less than previously reported based on inventory losses alone.

2. Nearly 15% of Co loss was discovered in bag house filters and in floor ventilation filters.

3. Over 50% of the Co loss is solid waste in the form of molten slag.

We'll talk more when the final written report from Sony hits my desk next week.


[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Notices]
[Pages 15051-15052]
[FR Doc No: 2023-04931]

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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 Policy, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
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: Kim Sapsford-Medintz, Office of
Product Evaluation and Quality, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 3216, 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.
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    \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.
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    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.
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    \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.
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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 December 7,
2022, through February 24, 2023, 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\
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    \3\ 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 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.
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     OnsiteGene, Inc.'s Hi-Sense COVID-19 Molecular Testing Kit
1.0, issued December 19, 2022;
     CTK Biotech, Inc.'s ImmuView COVID-19 Antigen Home Test,
issued December 20, 2022;
     Advin Biotech, Inc.'s Advin COVID-19 Antigen Test @Home,
issued December 22, 2022;
     Oceanit Foundry LLC's ASSURE-100 Rapid COVID-19 Home Test,
issued December 22, 2022;
     ADL Diagnostics, Inc.'s (dba Anavasi Diagnostics) The
AscencioDx COVID-19 Test and The AscencioDx Molecular Detector, issued
February 8, 2023;
     The HFI Laboratory at Boston University's (dba the BU
Clinical Testing Laboratory) BU SARS-CoV-2 Test, issued February 8,
2023;
     GenBody, Inc.'s GenBody COVID-19 Ag Home Test, issued
February 17, 2023; and
     Mologic, Inc.'s COVI-Go SARS-CoV-2 Ag Self-Test, issued
February 22, 2023.
    FDA is hereby announcing the following Authorizations for
multianalyte tests:
     Visby Medical, Inc.'s Visby Medical Respiratory Health
Test, issued December 23, 2022; \4\
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    \4\ As set forth in the EUA for this product, 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 such
product; and (3) there is no adequate, approved, and available
alternative to the emergency use of the product.
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     Becton, Dickinson and Company's BD Respiratory Viral Panel
for BD MAX System, issued February 3, 2023; \5\
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    \5\ As set forth in the EUA for this product, 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, influenza B virus and/or RSV nucleic acid, and
that the known and potential benefits of the product, when used for
diagnosing COVID-19, outweigh the known and potential risks of such
product; and (3) there is no adequate, approved, and available
alternative to the emergency use of the product.
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     LumiraDx UK Ltd.'s LumiraDx SARS-CoV-2 & Flu A/B RNA STAR
Complete Assay, issued February 3, 2023; \6\ and
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    \6\ As set forth in the EUA for this product, 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 such
product; and (3) there is no adequate, approved, and available
alternative to the emergency use of the product.
---------------------------------------------------------------------------

     Lucira Health, Inc.'s Lucira COVID-19 & Flu Home Test,
issued February 24, 2023.\7\
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    \7\ As set forth in the EUA for this product, FDA has concluded
that: (1) The 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 such product;
and (3) there is no adequate, approved, and available alternative to
the emergency use of the product.

    Dated: March 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04931 Filed 3-9-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Rules and Regulations]
[Pages 49480-49482]
[FR Doc No: 2021-19031]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2021-0366; FRL-8797-02-R9]

Air Plan Approval; California; San Diego County Air Pollution
Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve a revision to the San Diego County Air Pollution
Control District (SDCAPCD or ``District'') portion of the California
State Implementation Plan (SIP). This revision concerns emissions of
volatile organic compounds (VOCs) from gasoline transfers into
underground stationary storage tanks at gasoline dispensing facilities.
We are approving a local rule that regulates these emission sources
under the Clean Air Act (CAA or ``Act'').

DATES: This rule will be effective on October 4, 2021.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R09-OAR-2021-0366. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available through https://www.regulations.gov, or please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section for
additional availability information. If you need assistance in a
language other than English or if you are a person with disabilities
who needs a reasonable accommodation at no cost to you, please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Rebecca Newhouse, EPA Region IX, 75
Hawthorne St., San Francisco, CA 94105. By phone:<PHONE_NUMBER> or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Proposed Action

    On June 7, 2021,\1\ the EPA proposed to approve the following rule
into the California SIP.
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    \1\ 86 FR 30232.

----------------------------------------------------------------------------------------------------------------
         Local agency             Rule #       Rule title              Adopted                  Submitted
----------------------------------------------------------------------------------------------------------------
SDCAPCD.......................     61.3.1  Transfer of        March 1, 2006...........  August 9, 2017. \2\
                                            Gasoline into
                                            Stationary
                                            Underground
                                            Storage Tanks.
----------------------------------------------------------------------------------------------------------------

    We proposed to approve this rule because we determined that it
complies with the relevant CAA requirements. Our proposed action
contains more information on the rule and our evaluation.
---------------------------------------------------------------------------

    \2\ The District supplemented its submittal by providing
additional proof of public notice, submitted by CARB to the EPA on
December 28, 2020. Letter dated December 28, 2020, from Richard W.
Corey, Executive Officer, CARB, to John W. Busterud, Regional
Administrator, EPA, Region IX, transmitting the proof of public
notice in The Daily Transcript, and Minute Order No.1 from the
SDCAPCD Board hearing on October 14, 2020.
---------------------------------------------------------------------------

II. Public Comments and EPA Responses

    The EPA's proposed action provided a 30-day public comment period.
During this period, we received no comments.

III. EPA Action

    No comments were submitted. Therefore, as authorized in section
110(k)(3) of the Act, the EPA is fully approving this rule into the
California SIP. Additionally, we find that SDCAPCD has rectified the
deficiency identified in our December 3, 2020, partial disapproval \3\
of the District's reasonably available control technology (RACT)
analysis for the 2008 8-hr ozone National Ambient Air Quality Standard
(``2008 RACT SIP'') with respect to the source category covering the
``Design Criteria for Stage I Vapor Control Systems--Gasoline Service
Stations'' (EPA-450/R-75-102) Control Techniques Guidelines (``Stage I
Gasoline Transfer CTG''). This action terminates the sanctions and
Federal Implementation Plan (FIP) clocks associated with our partial
disapproval of the District's 2008 RACT SIP for the Stage I Gasoline
Transfer CTG.\4\ This action also satisfies the District's RACT
obligation for this source category with respect to the 2008 8-hr ozone
NAAQS.
---------------------------------------------------------------------------

    \3\ 85 FR 77996.
    \4\ This action does not stop or otherwise impact the sanctions
and FIP clocks associated with our partial disapproval of other CTG
source categories identified in our partial approval and partial
disapproval of the District's 2008 RACT SIP. See id.
---------------------------------------------------------------------------

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the
SDCAPCD rule described in the amendments to 40 CFR part 52 set forth
below. The EPA has made, and will continue to make, these documents
available through www.regulations.gov and at the EPA Region IX Office
(please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section of this preamble for more information).

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by November 2, 2021. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping

requirements, Volatile organic compounds.

    Dated: August 27, 2021.
Elizabeth Adams,
Acting Regional Administrator, Region IX.

    For the reasons stated in the preamble, the Environmental
Protection Agency amends part 52, chapter I, title 40 of the Code of
Federal Regulations as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Section 52.220 is amended by adding paragraph (c)(503)(i)(B)(2) to
read as follows:

Sec.  52.220   Identification of plan.

* * * * *
    (c) * * *
    (503) * * *
    (i) * * *
    (B) * * *
    (2) Rule 61.3.1, ``Transfer of Gasoline into Stationary Underground
Storage Tanks,'' adopted on March 1, 2006.
* * * * *

Sec.  52.237   [Amended]

0
3. Section 52.237 is amended by removing and reserving paragraph
(b)(2)(i)(A).

[FR Doc. 2021-19031 Filed 9-2-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 177 (Friday, September 12, 2014)]
[Notices]
[Page 54728]
[FR Doc No: 2014-21726]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1478]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Providing Waiver-Related Materials
in Accordance With Draft Guidance for Industry on Providing Postmarket
Periodic Safety Reports in the International Conference on
Harmonisation E2C(R2) Format

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled Providing Waiver-Related Materials
in Accordance with Draft Guidance for Industry on Providing
``Postmarket Periodic Safety Reports in the International Conference on
Harmonisation E2C(R2) Format'' has been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On June 19, 2014, the Agency submitted a
proposed collection of information entitled ``Providing Waiver-Related
Materials in Accordance with Draft Guidance for Industry on Providing
Postmarket Periodic Safety Reports in the International Conference on
Harmonisation E2C(R2) Format'' to OMB for review and clearance under 44
U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0771.
The approval expires on August 31, 2017. A copy of the supporting
statement for this information collection is available on the Internet
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: September 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21726 Filed 9-11-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: November 9, 2006 (Volume 71, Number 217)]
[Notices]
[Page 65789]
[DOCID:fr09no06-54]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP04-38-002]

Cheniere Sabine Pass Pipeline, L.P.; Notice of Errata to
Compliance Filing

November 2, 2006.
    Take notice that on October 27, 2006, Cheniere Sabine Pass Pipeline
Company (CSPP) filed an errata to its February 22, 2005 compliance
filing. Through this errata filing, CSPP submitted the Second Revised
Pro Forma Sheet No. 5 to its Pro Forma FERC Gas Tariff. All other
exhibits, including CSPP's Pro Forma FERC Gas Tariff, and explanations
submitted with the February 22, 2005 compliance filing remain
unchanged.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing 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. Such protests
must be filed on or before the date as indicated below. Anyone filing a
protest must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible online at http://www.ferc.gov, using the

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

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. eastern time on November 17, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-18940 Filed 11-8-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Notices]
[Pages 60513-60514]
[FR Doc No: 2011-25132]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3326-EM; Docket ID FEMA-2011-0001]

Puerto Rico; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of an
emergency for the Commonwealth of Puerto Rico (FEMA-3326-EM), dated
August 22, 2011, and related determinations.

DATES: Effective Date: August 22, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, 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 August 22, 2011, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5208 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in certain areas
of the Commonwealth of Puerto Rico resulting from Hurricane Irene
beginning on August 21, 2011, and continuing, are of sufficient
severity and magnitude to warrant an emergency 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 an emergency exists in the Commonwealth of Puerto Rico.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), limited to direct Federal assistance, under the Public
Assistance program. This assistance excludes regular time costs for
subgrantees' regular employees.
    Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. 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 emergency
assistance and administrative expenses.
    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, Department
of Homeland Security, under Executive Order 12148, as amended, Justo
Hern[aacute]ndez, of FEMA is appointed to act as the Federal
Coordinating Officer for this declared emergency.
    The following areas of the Commonwealth of Puerto Rico have been
designated as adversely affected by this declared emergency:

    All 78 municipalities in the Commonwealth of Puerto Rico for
emergency protective measures (Category B), limited to direct
Federal assistance, under the Public Assistance program at 75
percent Federal funding.

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.

    Dated: September 23, 2011.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-25132 Filed 9-28-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: April 13, 2010 (Volume 75, Number 70)]
[Notices]
[Page 18848]
[DOCID:fr13ap10-65]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Preparation for International Conference on Harmonisation
Steering Committee and Expert Working Group Meetings in Tallinn,
Estonia; Regional Public Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of meeting.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``Preparation for ICH Steering Committee and Expert
Working Group Meetings in Tallinn, Estonia'' to provide information and
receive comments on the International Conference on Harmonisation (ICH)
as well as the upcoming meetings in Tallinn, Estonia. The topics to be
discussed are the topics for discussion at the forthcoming ICH Steering
Committee Meeting. The purpose of the meeting is to solicit public
input prior to the next Steering Committee and Expert Working Group
meetings in Tallinn, Estonia, June 5 through 10, 2010, at which
discussion of the topics underway and the future of ICH will continue.
    Date and Time: The meeting will be held on Wednesday, May 5, 2010,
from 2:30 p.m. to 4:30 p.m.
    Location: The meeting will be held at the Washington Theater at the
Hilton Washington DC/Rockville Hotel & Executive Meeting Center, 1750
Rockville Pike, Rockville, MD 20852.
    Contact Person: All participants must register with Jennifer
Haggerty, Office of the Commissioner, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, by e-mail:
<EMAIL_ADDRESS>or FAX:<PHONE_NUMBER>.
    Registration and Requests for Oral Presentations: Send registration
information (including name, title, firm name, address, telephone, and
fax number), written material and requests to make oral presentations,
to the contact person by April 30, 2010.
    Interested persons may present data, information, or views orally
or in writing, on issues pending at the public meeting. Public oral
presentations will be scheduled between approximately 4 p.m. and 4:30
p.m. Time allotted for oral presentations may be limited to 10 minutes.
Those desiring to make oral presentations should notify the contact
person by April 30, 2010, and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses, phone number, fax, and e-mail of proposed participants, and
an indication of the approximate time requested to make their
presentation.
    The agenda for the public meeting will be made available via the
Internet at: http://www.fda.gov/Drugs/NewsEvents/ucm204924.htm.
    If you need special accommodations due to a disability, please
contact Jennifer Haggerty at least 7 days in advance.
    Transcripts: Please be advised that as soon as a transcript is
available, it can be obtained in either hardcopy or on CD-ROM, after
submission of a Freedom of Information request. Written requests are to
be sent to Division of Freedom of Information (HFI-35), Office of
Management Programs, Food and Drug Administration, 5600 Fishers Lane,
rm. 6-30, Rockville, MD 20857.

SUPPLEMENTARY INFORMATION: The ICH was established in 1990 as a joint
regulatory/industry project to improve, through harmonization, the
efficiency of the process for developing and registering new medicinal
products in Europe, Japan, and the United States without compromising
the regulatory obligations of safety and effectiveness.
    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for medical product development among regulatory agencies.
ICH was organized to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. ICH is concerned with harmonization among
three regions: The European Union, Japan, and the United States. The
six ICH sponsors are the European Commission; the European Federation
of Pharmaceutical Industries Associations; the Japanese Ministry of
Health, Labor and Welfare; the Japanese Pharmaceutical Manufactures
Association; the Centers for Drug Evaluation and Research and Biologics
Evaluation and Research, FDA; and the Pharmaceutical Research and
Manufacturers of America. The ICH Secretariat, which coordinates the
preparation of documentation, is provided by the International
Federation of Pharmaceutical Manufacturers Associations (IFPMA). The
ICH Steering Committee includes representatives from each of the ICH
sponsors and Health Canada, the European Free Trade Area, and the World
Health Organization. The ICH process has achieved significant
harmonization of the technical requirements for the approval of
pharmaceuticals for human use in the three ICH regions.
    The current ICH process and structure can be found at the following
Web site: http://www.ich.org.

    Dated: April 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8379 Filed 4-12-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Notices]
[Pages 18416-18417]
[FR Doc No: 2013-06795]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Sixth Meeting: RTCA Special Committee 226, Audio Systems and
Equipment

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

ACTION: Meeting Notice of RTCA Special Committee 226, Audio Systems and
Equipment.

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

SUMMARY: The FAA is issuing this notice to advise the public of the
sixth meeting of the RTCA Special Committee 226, Audio Systems and
Equipment.

DATES: The meeting will be held April 15-17, 2013 from 9:00 a.m.-5:00
p.m.

ADDRESSES: The meeting will be held at RTCA, 1150 18th Street NW.,
Suite 910, Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC 20036, or by telephone at (202) 330-
0652/(202) 833-9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org. In addition, Sophie Bouquet may be contacted directly at
(202) 330-0663, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of Special Committee 226. The agenda will
include the following:

 Welcome and Administrative Remarks
 Introductions
 Agenda Overview
 Review meeting minutes from January Working Group Meeting
 Comment period related to any actions taken at January Working
Group Meeting
 Review previous action items
 Solicit proposals for further changes to DO-214
 Continue discussion on the following:

    (a) A consistent method for testing of ANR headsets
    (b) A consistent method for testing of Oxygen Mask Microphones
    (c) Impedance to be used for headset standard
    (d) Additional tests required for

powered headsets
    (e) RF susceptibility issues
 Continue review of DO-214 and draft updates & changes since
last meeting
 Other Business
 Review open actions
 Establish agenda for next meeting & discuss actions to reach
 Adjourn

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on March 15, 2013.
Paige Williams,
Management Analyst, NextGen, Business Operations Group, Federal
Aviation Administration.
[FR Doc. 2013-06795 Filed 3-25-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 166 (Tuesday, August 27, 2019)]
[Notices]
[Pages 44893-44894]
[FR Doc No: 2019-18436]

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

[FRL-9999-02-Region 5]

Proposed CERCLA Administrative Settlement Agreement for Alreco
Metals Superfund Site, Benton Harbor, Michigan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed settlement agreement and request for public
comments.

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

SUMMARY: The Environmental Protection Agency (EPA) is giving notice of
a proposed administrative settlement for recovery of past response
costs concerning the Alreco Metals Superfund Site in Benton Harbor,
Michigan with the following settling parties: Louis Padnos Iron & Metal
Company; Toyota Motor Engineering & Manufacturing North America, Inc.;
and Service Aluminum Corporation. The EPA invites written public
comments on the Settlement for thirty (30) days following publication
of this notice. The settlement requires the settling parties to pay
$585,570.40 to the Hazardous Substance Superfund.

DATES: Comments must be received on or before September 26, 2019.

ADDRESSES: The proposed settlement and related documents can be viewed
at the Superfund Records Center (SRC-7J), United States Environmental
Protection Agency, Region 5, 77 W Jackson Blvd., Chicago, IL 60604,
(312) 886-4465 and on-line at https://response.epa.gov/site/site_profile.aspx?site_id=9619. You may send comments, referencing the
Alreco Metals Superfund Site in Benton Harbor, Michigan and identified
by Docket ID No. [V-W-19-C-010], to the following address: William
Greaves, Superfund & Emergency Management

Division (S-6J), U.S. Environmental Protection Agency, Region 5, 77
West Jackson Boulevard, Chicago, Illinois, 60604-3590.

FOR FURTHER INFORMATION CONTACT: Josh Zaharoff, Office of Regional
Counsel (C-14J), United States Environmental Protection Agency, Region
5, 77 West Jackson Boulevard, Chicago, Illinois 60604. Josh Zaharoff
may be reached by telephone at<PHONE_NUMBER> or via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background Information

    In accordance with Section 122(i) of the Comprehensive
Environmental Response, Compensation, and Liability Act, as amended
(``CERCLA''), 42 U.S.C. 9622(i), notice is hereby given of a proposed
administrative settlement for recovery of past response costs
concerning the Alreco Metals Site in Benton Harbor, Michigan with the
following settling parties: Louis Padnos Iron & Metal Company; Toyota
Motor Engineering & Manufacturing North America, Inc.; and Service
Aluminum Corporation. EPA completed a removal action at the Site that
began on August 8, 2014. The Site is located in an industrial/
commercial area along the banks of the Paw Paw River and is
approximately 28 acres in size. The settlement requires the settling
parties to pay $585,570.40 to the Hazardous Substance Superfund. The
settlement includes a covenant not to sue the settling parties pursuant
to Section 107(a) of CERCLA, 42 U.S.C. 9607(a).

II. Opportunity to Comment

A. General Information

    For thirty (30) days following the date of publication of this
notice, the Agency will receive written comments relating to the
Settlement. The Agency will consider all comments received and may
modify or withdraw its consent to the Settlement if comments received
disclose facts or considerations which indicate that the Settlement is
inappropriate, improper, or inadequate.

B. Where do I send my comments or view responses?

    Your comments should be mailed to William Greaves, Superfund &
Emergency Management Division (S-6J), U.S. Environmental Protection
Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois, 60604-
3590. Be sure to label the comments with the Docket Number at the top
of this notice and/or the property name. The Agency's response to any
comments received will be available for public inspection at the
Superfund Records Center.

C. What should I Consider as I prepare my comments for EPA?

    1. Submitting Confidential Business Information (CBI). Do not
submit ANY information you think or know is CBI to EPA through an
agency website or via email. Clearly mark on your written comments all
the information that you claim to be CBI. If you mail EPA your comments
on a disk or CD-ROM (CD), mark the outside of the CD as CBI and then
identify electronically within the CD the specific information that is
claimed as CBI. In addition to one complete version of your comments
that includes all the information claimed as CBI, you must submit for
inclusion in the public docket a second copy of your comments that does
not contain the information claimed as CBI. Information marked as CBI
will not be disclosed except in accordance with procedures set forth in
40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the subject of your comments by the docket number
and the site name in the title of this notice or the Federal Register
publication date and page number.
     Follow directions--the agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree with the terms of the
Settlement; suggest alternatives and substitute language for your
requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the identified
comment period deadline.

    Dated: June 14, 2019.
Douglas Ballotti,
Director, Superfund & Emergency Management Division.
[FR Doc. 2019-18436 Filed 8-26-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 77 (Friday, April 21, 2023)]
[Notices]
[Pages 24657-24659]
[FR Doc No: 2023-08413]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2023-0002-N-09]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of information collection; request for comment.

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SUMMARY: Under the Paperwork Reduction Act of 1995 (PRA) and its
implementing regulations, FRA seeks approval of the Information
Collection Request (ICR) abstracted below. Before submitting this ICR
to the Office of Management and Budget (OMB) for approval, FRA is
soliciting public comment on specific aspects of the activities
identified in the ICR.

DATES: Interested persons are invited to submit comments on or before
June 20, 2023.

ADDRESSES: Written comments and recommendations for the proposed ICR
should be submitted on regulations.gov to the docket, Docket No. FRA-
2023-0002. All comments received will be posted without change to the
docket, including any personal information provided. Please refer to
the assigned OMB control number (2130-0500) in any correspondence
submitted. FRA will summarize comments received in response to this
notice in a subsequent notice and include them in its information
collection submission to OMB for approval.

FOR FURTHER INFORMATION CONTACT: Ms. Arlette Mussington, Information
Collection Clearance Officer, at email: [email protected] or
telephone:<PHONE_NUMBER> or Ms. Joanne Swafford, Information
Collection Clearance Officer, at email: [email protected] or
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The PRA, 44 U.S.C. 3501-3520, and its
implementing regulations, 5 CFR part 1320, require Federal agencies to
provide 60-days' notice to the public to allow comment on information
collection activities before seeking OMB approval of the activities.
See 44 U.S.C. 3506, 3507; 5 CFR 1320.8 through 1320.12. Specifically,
FRA invites interested parties to comment on the following ICR
regarding: (1) whether the information collection activities are
necessary for FRA to properly execute its functions, including whether
the activities will have practical utility; (2) the accuracy of FRA's
estimates of the burden of the information collection activities,
including the validity of the methodology and assumptions used to
determine the estimates; (3) ways for FRA to enhance the quality,
utility, and clarity of the information being collected; and (4) ways
for FRA to minimize the burden of information collection activities on
the public, including the use of automated collection techniques or
other forms of information technology. See 44 U.S.C. 3506(c)(2)(A); 5
CFR 1320.8(d)(1).
    This ICR responds to the information collection mandate in Section
22421(b) of the Infrastructure Investment and Jobs Act (IIJA) and also
provides routine updates to 49 CFR part 225's overall information
collection request renewal.
    FRA believes that soliciting public comment may reduce the
administrative and paperwork burdens associated with the collection of
information that Federal statutes and regulations mandate. In summary,
FRA reasons that comments received will advance three objectives: (1)
reduce reporting burdens; (2) organize information collection
requirements in a ``user-friendly'' format to improve the use of such
information; and (3) accurately assess the resources expended to
retrieve and produce information requested. See 44 U.S.C. 3501.
    The summary below describes the ICR that FRA will submit for OMB
clearance as the PRA requires:
    Title: Accident/Incident Reporting and Recordkeeping.
    OMB Control Number: 2130-0500.
    Abstract: The railroad accident/incident reporting regulations in
49 CFR part 225 require railroads to submit reports summarizing
collisions, derailments, and certain other accidents/incidents
involving damages above a periodically revised dollar threshold, as
well as certain injuries to passengers, employees, and other persons on
railroad property. As the reporting requirements and the information
needed regarding each category of accident/incident are unique, a
different form is used for each category.
    In response to the mandate in IIJA Section 22421,\1\ FRA intends to
utilize Form FRA F 6180.54 Special Study Blocks 49a and 49b to collect
the following information for a projected five-year period: (1) the
length of the involved trains, in feet, and (2) the number of crew
members who were aboard a controlling locomotive involved in an
accident at the time of such accident. This modification produces a
minimal additional burden with respect to what is already being
reported, as FRA estimates that the utilization of the Special Study
Blocks will require an additional 2 minutes to complete, for a total
average burden time of approximately 2 hours and 2 minutes per form,
adding an additional 57 hours to the overall collection request.
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    \1\ Specifically, IIJA section 22421(b) requires FRA to update
Special Study Block 49 on Form FRA F 6180.54, for a period of five
years, to collect information on: (1) the number of cars and length
of trains involved in an accident/incident; and (2) the number of
crew members who were aboard a controlling locomotive involved in an
accident at the time of such accident. Railroads are already
required to report the number of cars in the consist of a train
involved in an accident on Form FRA F 6180.54, Field 35.
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    In this 60-day notice, FRA has made multiple adjustments to its
estimated paperwork burden for the entire part 225 collection request,
resulting in a reduction of 5,563 hours, from 35,846 hours in the
current inventory, to 30,283 hours in the requested inventory. The
primary reason for the reduction in the estimated paperwork burden is
the expected decrease in the number of submissions. Specifically, under
Sec.  225.19(d), FRA expects submissions will decrease significantly
from 11,636 hours to 7,040 hours due to a reduction in the number of
injuries reported in the last two years. There is no change in the
method of collection; this is a routine update for this 3-year ICR
renewal period.
    Type of Request: Revision of a currently approved collection.
    Affected Public: Businesses.
    Form(s): FRA F 6180.54; .55; .55a; .56; .57; .78; .81; .97; .98;
.107; .150.
    Respondent Universe: 784 railroads.
    Frequency of Submission: On occasion.
    Reporting Burden:

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                                                                                Total
                                                                                annual      Total cost
          CFR section                 Respondent universe           Total annual responses       Average time per response      burden     equivalent in
                                                                                hours       U.S. dollar
                                                                (A)..........................  (B).........................  (C = A * B)        (D = C *
                                                                                wage rates)
                                                                                \2\
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225.6(a)--Consolidated           784 railroads................  0.33 requests................  40.00 hours.................        13.20       $1,028.41
 reporting--Request to FRA by
 parent corporation to treat
 its commonly controlled
 carriers as a single railroad
 carrier for purposes of this
 part.
                                ------------------------------------------------------------------------------------------------------------------------
    --(b) Written agreement by   The burden for this requirement is included in Sec.   225.6(a).
     parent corporation with
     FRA on specific
     subsidiaries included in
     its railroad system.
                                ------------------------------------------------------------------------------------------------------------------------
    --(c) Notification by        The burden for this requirement is included in Sec.   225.6(a).
     parent corporation
     regarding any change in
     the subsidiaries making up
     its railroad system and
     amended written agreement
     with FRA.
                                ------------------------------------------------------------------------------------------------------------------------
225.9--Telephonic reports of     784 railroads................  2,589.00 phone reports.......  15.00 minutes...............       647.25       50,427.25
 certain accidents/incidents
 and other events.
225.11--Reporting of accidents/  784 railroads................  1,699.00 forms...............  2 hours + 2 minutes.........     3,454.63      269,150.22
 incidents--Form FRA F 6180.54
 (IIJA created an additional
 burden of 2 minutes to what is
 already being reported.).
225.12(a)--Rail equipment        784 railroads................  732.00 forms.................  15.00 minutes...............       183.00       14,257.53
 accident/incident reports
 alleging human factor as
 cause--Form FRA F 6180.81.
    --(b) Part I Form FRA F      784 railroads................  800 notices + 800 notice       10 minutes + 3 minutes......       333.83       26,008.70
     6180.78 (Notices).                                          copies + 3,200 copies + 10
                                                                 copies.
    --(c) Joint operations.....  784 railroads................  73.00 reports................  20.00 minutes...............        24.00        1,869.84
    --(d) Late identification..  784 railroads................  20 attachments + 20 notices..  10.00 minutes...............         6.67          519.66
    --(g) Employee statement     Railroad employees...........  60.00 statements.............  1.50 hours..................        90.00        7,011.90
     supplementing railroad
     accident report (Part II
     Form FRA 6180.78).
    --(g)(3) Employee            Railroad employees...........  5.00 letters.................  2.00 hours..................        10.00          779.10
     confidential letter.
225.13(A)--Late reports--RR      784 railroads................  50.00 late reports...........  2.00 hours..................       100.00        7,791.00
 discovery of improperly
 omitted report of accident/
 incident.
    --(B) RR late/amended        784 railroads................  20 amended reports + 30        1 hour + 3 minutes..........        21.50        1,675.07
     report of accident/                                         copies.
     incident based on employee
     statement supplementing RR
     accident report.
225.18(a)--RR narrative report   784 railroads................  12.00 reports................  15.00 minutes...............         3.00          233.73
 of possible alcohol/drug
 involvement in accident/
 incident.
    --(b) Reports required by    784 railroads................  5.00 reports.................  30.00 minutes...............         2.50          194.78
     Sec.   219.209(b) appended
     to rail equipment accident/
     incident report.
225.19(a)--Rail-highway grade    784 railroads................  2,161.50 forms...............  2.00 hours..................     4,323.00      336,804.93
 crossing accident/incident
 report--Form FRA F 6180.57.
    --(d) Death, injury, or      784 railroads................  7,040.00 forms...............  1.00 hour...................     7,040.00      548,486.40
     occupational illness (Form
     FRA F 6180.55a).
225.21--Railroad injury and      784 railroads................  9,408.00 forms...............  10.00 minutes...............     1,568.00      122,162.88
 illness summary--Form FRA F
 6180.55.
225.21--Annual railroad report   784 railroads................  784.00 forms.................  15.00 minutes...............       196.00       15,270.36
 of employee hours and
 casualties, by state--Form FRA
 F 6180.56.
225.21/25--Railroad employee     784 railroads................  4,000.00 forms...............  1.00 hour...................     4,000.00      311,640.00
 injury and/or illness record--
 Form FRA F 6180.98.
    --Copies of forms to         784 railroads................  3.60 form copies.............  2.00 minutes................         0.12            9.35
     employees.
225.21--Initial rail equipment   784 railroads................  10,194.00 forms..............  30.00 minutes...............     5,097.00      397,107.27
 accident/incident record--Form
 FRA F 6180.97.
                                ------------------------------------------------------------------------------------------------------------------------
    --Completion of Form FRA F   FRA anticipates zero railroad submissions during this 3-year ICR period.
     6180.97 because of rail
     equipment involvement.
                                ------------------------------------------------------------------------------------------------------------------------
    --Alternative record for     784 railroads................  150.00 forms.................  75.00 minutes...............       187.50       14,608.13
     illnesses claimed to be
     work related--Form FRA F
     6180.107.
    --Highway User Statement--   784 railroads................  721.00 letters/forms.........  50.00 minutes...............       600.83       46,810.67
     RR cover letter and Form
     FRA F 6180.150 sent out to
     potentially injured
     travelers involved in a
     highway-rail grade
     crossing accident/incident.
    --Form FRA F 6180.150        117 injured individuals......  117.00 forms.................  45.00 minutes...............        87.75        6,836.60
     completed by highway user
     and sent back to railroad.
225.25(h)--Posting of monthly    784 railroads................  9,408.00 lists...............  5.00 minutes................       784.00       61,081.44
 summary.
225.27(a)(1)--Retention of       784 railroads................  7,500.00 records.............  2.00 minutes................       250.00       19,477.50
 records.
                                ------------------------------------------------------------------------------------------------------------------------
    --Record of Form FRA F       The estimated paperwork burden for this requirement is included in 225.21 (Alternative record for illnesses claimed to
     6180.107s.                   be work related).
                                ------------------------------------------------------------------------------------------------------------------------
    --Record of Monthly Lists..  784 railroads................  9,408.00 records.............  2.00 minutes................       313.60       24,432.58
    (a)(2)--Record of Form FRA   784 railroads................  10,194.00 records............  2.00 minutes................       339.80       26,473.82
     F 6180.97.
    --Record of employee human   784 railroads................  1,464.00 records.............  2.00 minutes................        48.80        3,802.01
     factor attachments.
225.33--Internal Control Plans-- 784 railroads................  10.00 amendments.............  6.00 hours..................        60.00        4,674.60
 Amendments.

225.35--Access to records and    784 railroads................  784.00 lists.................  20.00 minutes...............       261.33       20,360.22
 reports.
                                ------------------------------------------------------------------------------------------------------------------------
225.37(a)--Optical media         FRA anticipates zero submissions during this 3-year ICR period.
 transfer of reports, updates,
 and amendments.
                                ------------------------------------------------------------------------------------------------------------------------
    (c)(2)--Electronic           784 railroads................  4,704.00 submissions.........  3.00 minutes................       235.20       18,324.43
     submission of reports,
     updates, and amendments.
                                ------------------------------------------------------------------------------------------------------------------------
        Totals \3\.............  784 railroads................  85,570 responses.............  N/A.........................       30,283       2,359,310
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    Total Estimated Annual Responses: 85,570.
    Total Estimated Annual Burden: 30,283 hours.
    Total Estimated Annual Burden Hour Dollar Cost Equivalent:
2,359,310.
    FRA informs all interested parties that it may not conduct or
sponsor, and a respondent is not required to respond to, a collection
of information that does not display a currently valid OMB control
number.
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    \2\ The dollar equivalent cost is derived from the 2021 Surface
Transportation Board Full Year Wage A&B data series using the
appropriate employee group hourly wage rage that includes a 75
percent overhead charge.
    \3\ Totals may not add due to rounding.
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    Authority: 44 U.S.C. 3501-3520.

Brett A. Jortland,
Deputy Chief Counsel.
[FR Doc. 2023-08413 Filed 4-20-23; 8:45 am]
BILLING CODE 4910-06-P