			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on October 23, 2002

NOTICE OF ACTION TAKEN -- DOCKET OST 2002-13383

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  PROPAIR INC.
         Date Filed:  September 18, 2002

Relief requested:  Exemption from 49 USC section 41301 to permit the
applicant to conduct, using small equipment (see below), passenger and
cargo charter operations between Canada and the United States, and other
charters in accordance with 14 CFR Part 212.

Applicant representative:  Ron Tuggey,<PHONE_NUMBER>        DOT analyst:
Allen F. Brown,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved.			   			                    Action date:  October 23,
2002

Effective dates of authority granted:  October 23, 2002, through October
23, 2003.

Basis for approval (bilateral agreement/reciprocity):  United
States-Canada Air Transport Agreement (Agreement)

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:  Standard exemption
conditions.

Special conditions/Remarks:  In the conduct of these operations, the
carrier may only use aircraft designed to have a maximum passenger
capacity of not more than 60 seats or a maximum payload capacity of not
more than 18,000 pounds.  The above grant includes authority to conduct
Third and Fourth Freedom charter operations.  Charter operations to be
conducted under this authority that would not operate between Canada and
the United States, however, are subject to prior approval under 14 CFR
Part 212.

Action taken by:   Paul L. Gretch, Director, Office of International
Aviation

________________________________________________________________________
______________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp


From:
David Ailor<EMAIL_ADDRESS>Sent:
Wednesday, December 29, 2021 6:30 PM
To:
Jones, DonnaLee<EMAIL_ADDRESS>Cc:
Raymond, Gabrielle<EMAIL_ADDRESS>'Hardin, Christopher W'<EMAIL_ADDRESS>Subject:
RE: PROven coke technology

Hello again, Donna Lee.  Hope your recovery from surgery is going well.

I'm following up regarding your December 20 inquiry regarding "pressure regulated oven" (PROven) technology.  I sent your inquiry to USS and the other COETF member companies for review.

Based on the feedback I have received, the only known application of this technology in the US is on Battery C at USS-Clairton.  It was possible to construct Battery C with PROven technology because the technology was included as part of the original design prior to the battery starting up in November 2012.  The cost of the technology was included in the original battery construction cost; however, USS lacks any information regarding the itemized cost of the PROven technology separate from the other components of the battery.  All of the other USS-Clairton batteries were constructed before Battery C.

COETF members are not aware of any applications of PROven technology - either the original generation or the "next generation" of the technology described in the vendor's presentation materials you sent (attached) - to existing batteries in the US.  Hence, we have no information on the feasibility, efficacy, or cost of trying to retrofit PROven on existing coke ovens.

Contact me if you have additional questions.  Thanks, DCA

David C. Ailor, P.E.
President
American Coke and Coal Chemicals Institute
25 Massachusetts Avenue, N.W.
Suite 800
Washington, D.C. 20001
Phone:<PHONE_NUMBER>
eFax.:<PHONE_NUMBER>
<EMAIL_ADDRESS>www.accci.org

<< Appendix A-Proven NG for AISTech16.pdf >>

From: Jones, DonnaLee<EMAIL_ADDRESS>Sent: Monday, December 20, 2021 1:47 PM
To: David Ailor<EMAIL_ADDRESS>Cc: 'GABRIELLE RAYMOND'<EMAIL_ADDRESS>'Hardin, Christopher W'<EMAIL_ADDRESS>Subject: RE: PROven coke technology

Soon. But after new year is fine.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.

From: David Ailor<EMAIL_ADDRESS>Sent: Monday, December 20, 2021 1:11 PM
To: Jones, DonnaLee<EMAIL_ADDRESS>Cc: 'GABRIELLE RAYMOND'<EMAIL_ADDRESS>'Hardin, Christopher W'<EMAIL_ADDRESS>Subject: RE: PROven coke technology

Happy Holidays, Donna Lee!  Hope you're surgery went well.

I'll make some inquiries.  When do you want/need an answer?  DCA

David C. Ailor, P.E.
President
American Coke and Coal Chemicals Institute
25 Massachusetts Avenue, N.W.
Suite 800
Washington, D.C. 20001
Phone:<PHONE_NUMBER>
eFax.:<PHONE_NUMBER>
<EMAIL_ADDRESS>www.accci.org

From: Jones, DonnaLee<EMAIL_ADDRESS>Sent: Monday, December 20, 2021 12:41 PM
To: David Ailor<EMAIL_ADDRESS><EMAIL_ADDRESS>Cc: GABRIELLE RAYMOND<EMAIL_ADDRESS>Hardin, Christopher W<EMAIL_ADDRESS>Subject: PROven coke technology

Hi David. Hope you are well and ready for a holiday. I had a question that I may have asked you before. I had received information about the PROven technology for coke ovens. It seems to regulate oven pressure and reduce emissions during charging. The company would not/could not provide costs nor emission reductions. I will be including this technology in the "technology review" memo for the coke RTR. The coke facility using this technology cited in the information provided by the company is US Steel Clairton (pg. 23 of the pdf attached). Can you inquire as to the costs and reductions, and why a facility would use the technology for only some batteries and not all? And also confirm that its benefit is only for charging.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.

<< Appendix A-Proven NG for AISTech16.pdf >>


[Federal Register Volume 80, Number 211 (Monday, November 2, 2015)]
[Notices]
[Pages 67485-67489]
[FR Doc No: 2015-27784]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2015-0209; Notice No. 15-21]

Hazardous Materials: Explosive Approvals--Compliance With Special
Provision 347

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Proposed termination of explosive approvals.

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

SUMMARY: PHMSA proposes to terminate the explosive approvals listed
herein. PHMSA, via certified mail, attempted to contact all of the
below listed approval holders during the month of October 2014. The
certified letters were titled ``Hazardous Materials Safety Law
Division, Letter of Warning: Test Series 6(d) requirements for Division
1.4S Explosive Approvals.'' The certified letters requested that the
approval holders notify PHMSA within 30 days with their intent with
respect to the approvals. They were given the options to provide
evidence of UN 6(d) testing, request a reassignment of the EX number to
a higher compatibility group than ``S'', or request termination. To
date, no correspondence has been received by PHMSA concerning the below
listed explosive approval numbers.

FOR FURTHER INFORMATION CONTACT: Mr. Ryan Paquet, Director, Approvals
and Permits Division, Office of Hazardous Materials Safety, (202) 366-
4512, PHMSA, 1200 New Jersey Avenue SE., Washington, DC 20590.
Correspondence with respect to the below listed explosive approval
numbers should be sent to<EMAIL_ADDRESS>subject line--``UN 6(d)
Testing'' or respond to the listed address for Mr. Ryan Paquet.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In this notice, PHMSA's Office of Hazardous Materials Safety (OHMS)
is proposing to terminate the approvals listed below for the approval
holders' failure to provide PHMSA with evidence that UN 6(d) testing
has been performed in accordance with 49 CFR 172.102(c)(1) (Special
Provision 347) or requesting a reassignment of the EX number to a
higher compatibility group other than ``S''.

II. Background

    On January 19, 2011, PHMSA published a final rule (76 FR 3308; HM-
215K) titled ``Hazardous Materials: Harmonization with the United
Nations Recommendations, International Maritime Dangerous Goods Code,
and the International Civil Aviation Organization Technical
Instructions for the Safe Transport of Dangerous Goods by Air''. The
final rule amended Special Provision 347 to require successful testing
according to UN Test Series 6(d) of Part I of the UN Manual of Tests
and Criteria. This change affected explosives classified as Division
1.4S, and impacted eight UN Numbers, including: UN0323, UN0366, UN0441,
UN0445, UN0455, UN0456, UN0460, and UN0500. This requirement became
effective for transportation by aircraft on July 1, 2011, for
transportation by vessel on January 1, 2012, and for domestic highway
and rail transportation on January 1, 2014. PHMSA has no records of the
required UN 6(d) testing for the below listed EX numbers.

III. Action

    PHMSA will terminate the below listed approvals 30 days after this
notice is published in the Federal Register, unless the holder requests
reconsideration as outlined in 49 CFR 107.715.

IV. Approvals Scheduled for Termination

------------------------------------------------------------------------
                 EX No.                           Holder/company
------------------------------------------------------------------------
EX1986060084...........................  Overland Aviation Services
                                          Company, Inc.
EX1986060085...........................  Overland Aviation Services
                                          Company, Inc.
EX1986060086...........................  Overland Aviation Services
                                          Company, Inc.
EX1986060087...........................  Overland Aviation Services
                                          Company, Inc.
EX1986060088...........................  Overland Aviation Services
                                          Company, Inc.
EX1986060089...........................  Overland Aviation Services
                                          Company, Inc.
EX1986060090...........................  Overland Aviation Services
                                          Company, Inc.
EX1986060091...........................  Overland Aviation Services
                                          Company, Inc.
EX1986060092...........................  Overland Aviation Services
                                          Company, Inc.
EX1986060093...........................  Overland Aviation Services
                                          Company, Inc.
EX1986060094...........................  Overland Aviation Services
                                          Company, Inc.
EX1986060095...........................  Overland Aviation Services
                                          Company, Inc.

EX1986060096...........................  Overland Aviation Services
                                          Company, Inc.
EX1986060097...........................  Overland Aviation Services
                                          Company, Inc.
EX1986060098...........................  Overland Aviation Services
                                          Company, Inc.
EX1986060099...........................  Overland Aviation Services
                                          Company, Inc.
EX1986060100...........................  Overland Aviation Services
                                          Company, Inc.
EX1986060101...........................  Overland Aviation Services
                                          Company, Inc.
EX1986060102...........................  Overland Aviation Services
                                          Company, Inc.
EX1986060103...........................  Overland Aviation Services
                                          Company, Inc.
EX1987020126...........................  Hi-Shear Technology
                                          Corporation.
EX1987030332A..........................  Teledyne McCormick Selph.
EX1987060024...........................  BAE Systems (formerly Tracor
                                          Aerospace, Inc.--Arkansas
                                          Operations).
EX1987060025...........................  BAE Systems (formerly Tracor
                                          Aerospace, Inc.--Arkansas
                                          Operations).
EX1987070074...........................  Morton Thiokol, Inc.--Elkton
                                          Division.
EX1987070148...........................  Stresau Laboratory, Inc.
EX1987090043...........................  Accurate Energetic Systems,
                                          LLC.
EX1987100321...........................  Irvin Industries, Inc.
EX1987110222...........................  Kidde Fenwal (formerly, Fenwal
                                          Safety Systems, Inc.).
EX1988030074...........................  Armor Holding, Inc. Co.
EX1988030075...........................  Armor Holding, Inc. Co.
EX1988080029...........................  Lockheed Martin Corporation,
                                          Vought Systems (formerly LTV
                                          Missiles).
EX1989090127...........................  Day & Zimmermann, Inc.
EX1989100085...........................  U.S. Department of Energy.
EX1989110010...........................  Overland Aviation Services
                                          Company, Inc.
EX1989120028...........................  Conax Florida Corporation.
EX1990040344...........................  Atlantic Research Corporation.
EX1990060035...........................  Conax Florida Corporation.
EX1990060149...........................  U.S. Department of Energy.
EX1990060150...........................  U.S. Department of Energy.
EX1990060151...........................  U.S. Department of Energy.
EX1990060152...........................  U.S. Department of Energy.
EX1990060153...........................  U.S. Department of Energy.
EX1990060154...........................  U.S. Department of Energy.
EX1990090111...........................  Conax Florida Corporation.
EX1990090112...........................  Conax Florida Corporation.
EX1990090218...........................  DuPont Chemicals.
EX1990090219...........................  DuPont Chemicals.
EX1990090220...........................  DuPont Chemicals.
EX1990090221...........................  DuPont Chemicals.
EX1990090222...........................  DuPont Chemicals.
EX1990090223...........................  DuPont Chemicals.
EX1990090224...........................  DuPont Chemicals.
EX1990090225...........................  DuPont Chemicals.
EX1990090226...........................  DuPont Chemicals.
EX1990090227...........................  DuPont Chemicals.
EX1990090228...........................  DuPont Chemicals.
EX1990090229...........................  DuPont Chemicals.
EX1990090230...........................  DuPont Chemicals.
EX1990100010...........................  Conax Florida Corporation.
EX1990120121...........................  U.S. Department of Energy.
EX1991010042...........................  Hercules Aerospace Company.
EX1991010043...........................  Hercules Aerospace Company.
EX1991040147B..........................  Daicel Chemical Industries,
                                          Ltd.
EX1991040148...........................  Daicel Chemical Industries,
                                          Ltd.
EX1991050265...........................  Conax Florida Corporation.
EX1991050282...........................  Martin Electronics, Inc.
EX1991060062...........................  Kidde-Graviner Limited.
EX1991060237...........................  Mecano-Tech, Inc.
EX1991060238...........................  Mecano-Tech, Inc.
EX1991060239...........................  Mecano-Tech, Inc.
EX1991060240...........................  Mecano-Tech, Inc.
EX1991060241...........................  Mecano-Tech, Inc.
EX1991060242...........................  Mecano-Tech, Inc.
EX1991060243...........................  Mecano-Tech, Inc.
EX1991060244...........................  Mecano-Tech, Inc.
EX1991060245...........................  Mecano-Tech, Inc.
EX1991060246...........................  Mecano-Tech, Inc.
EX1991060247...........................  Mecano-Tech, Inc.
EX1991060248...........................  Mecano-Tech, Inc.
EX1991100087...........................  Conax Florida Corporation.
EX1991100088...........................  Conax Florida Corporation.
EX1991110085...........................  Aerospatiale Helicopter
                                          Corporation.
EX1991110251...........................  Mecano-Tech, Inc.
EX1991110252...........................  Mecano-Tech, Inc.
EX1991110253...........................  Mecano-Tech, Inc.

EX1991110254...........................  Mecano-Tech, Inc.
EX1992010163...........................  Conax Florida Corporation.
EX1992010166...........................  Conax Florida Corporation.
EX1992010167...........................  Conax Florida Corporation.
EX1992010168...........................  Conax Florida Corporation.
EX1992010196...........................  U.S. Department of Energy.
EX1992020009...........................  Applied Energy Technology
                                          Corporation.
EX1992020010...........................  Applied Energy Technology
                                          Corporation.
EX1992020011...........................  Applied Energy Technology
                                          Corporation.
EX1992020012...........................  Applied Energy Technology
                                          Corporation.
EX1992070022...........................  Conax Florida Corporation.
EX1992110059...........................  Teledyne McCormick Selph.
EX1993050235...........................  Royal Ordnance Plc.
EX1993080189...........................  Mecano-Tech, Inc.
EX1993080190...........................  Mecano-Tech, Inc.
EX1993080191...........................  Mecano-Tech, Inc.
EX1993080192...........................  Mecano-Tech, Inc.
EX1993080193...........................  Mecano-Tech, Inc.
EX1993080194...........................  Mecano-Tech, Inc.
EX1993080195...........................  Mecano-Tech, Inc.
EX1993080196...........................  Mecano-Tech, Inc.
EX1993080277...........................  Mecano-Tech, Inc.
EX1993080278...........................  Mecano-Tech, Inc.
EX1993080279...........................  Mecano-Tech, Inc.
EX1993080280...........................  Mecano-Tech, Inc.
EX1993080281...........................  Mecano-Tech, Inc.
EX1993080282...........................  Mecano-Tech, Inc.
EX1993080283...........................  Mecano-Tech, Inc.
EX1993090038...........................  Overland Aviation Services
                                          Company, Inc.
EX1993090039...........................  Overland Aviation Services
                                          Company, Inc.
EX1993090040...........................  Overland Aviation Services
                                          Company, Inc.
EX1993090041...........................  Overland Aviation Services
                                          Company, Inc.
EX1993090042...........................  Overland Aviation Services
                                          Company, Inc.
EX1993090043...........................  Overland Aviation Services
                                          Company, Inc.
EX1993090044...........................  Overland Aviation Services
                                          Company, Inc.
EX1994030058...........................  Olin Corporation--Winchester
                                          Division.
EX1994050293...........................  Teledyne McCormick Selph.
EX1994090107...........................  Royal Ordnance Plc.
EX1994100002...........................  Allied Signal, Inc.
EX1994100003...........................  Allied Signal, Inc.
EX1994120149...........................  Pacific Scientific/Energy
                                          Dynamics Div. (PS/EDD).
EX1995060001...........................  Austin Powder Company.
EX1995060002...........................  Austin Powder Company.
EX1995120030...........................  British Aerospace Defence
                                          Limited.
EX1996080062...........................  Water Well Redevelopers, Inc.
EX1996100133...........................  Dynamit Nobel GmbH.
EX1996100134...........................  Dynamit Nobel GmbH.
EX1996100135...........................  Dynamit Nobel GmbH.
EX1996100136...........................  Dynamit Nobel GmbH.
EX1997050058...........................  Illinois Tool Works (ITW) SPIT.
EX1997050127...........................  Ensign-Bickford Company.
EX1997050128...........................  Ensign-Bickford Company.
EX1997080110...........................  Kidde-Fenwal, Inc.
EX1997100009...........................  Martin Electronics, Inc.
EX1997110018...........................  Pacific Scientific/Energy
                                          Dynamics Div. (PS/EDD).
EX1998090010...........................  Ensign-Bickford Company.
EX1998090011...........................  Ensign-Bickford Company.
EX1998090012...........................  Ensign-Bickford Company.
EX1998090013...........................  Ensign-Bickford Company.
EX1998090014...........................  Ensign-Bickford Company.
EX1998090015...........................  Ensign-Bickford Company.
EX1998090016...........................  Ensign-Bickford Company.
EX1998090017...........................  Ensign-Bickford Company.
EX1998090018...........................  Ensign-Bickford Company.
EX1998090129...........................  Ensign-Bickford Company.
EX1998110069...........................  Accles & Shelvoke Limited.
EX1999010089...........................  Swartklip Products.
EX1999010221...........................  Ensign-Bickford Company.
EX1999010222...........................  Ensign-Bickford Company.
EX1999010223...........................  Ensign-Bickford Company.
EX1999010224...........................  Ensign-Bickford Company.
EX1999010225...........................  Ensign-Bickford Company.
EX1999010227...........................  Ensign-Bickford Company.
EX1999010228...........................  Ensign-Bickford Company.

EX1999010229...........................  Ensign-Bickford Company.
EX1999030008...........................  Teledyne Ryan Aeronautical--
                                          McCormick Selph Ordn.
EX1999030073...........................  Nato Ammo Depot, Glen Douglas.
EX1999090169...........................  Mecano-Tech, Inc.
EX1999100004...........................  Pains-Wessex, Limited.
EX1999110049...........................  Teledyne Ryan Aeronautical--
                                          McCormick Selph Ordn.
EX2000040159...........................  Swartklip Products.
EX2000080028...........................  The Boeing Company.
EX2000090072...........................  Swartklip Products.
EX2000090120...........................  Daicel Chemical Industries,
                                          Ltd.
EX2000120150...........................  Swartklip Products.
EX200030318A...........................  LifeSparc.
EX2001010178...........................  Diplomat Freight Services.
EX2001010186...........................  Action Manufacturing Company.
EX2001040019...........................  Ridgeway International Limited.
EX2001050013...........................  Somchem, division of Denel
                                          (Pty) Ltd.
EX2001050187...........................  Pacific Scientific.
EX2001050188...........................  Pacific Scientific.
EX2002100057A..........................  LifeSparc.
EX2002100057B..........................  LifeSparc.
EX2003030318...........................  LifeSparc.
EX2003060206...........................  Universal Propulsion Company
                                          Seating & Propulsion Systems.
EX2003060206A..........................  Universal Propulsion Company,
                                          Inc.
EX2003060206B..........................  Universal Propulsion Company
                                          Goodrich Corporation.
EX2003070009...........................  Daicel Chemical Industries,
                                          Ltd.
EX2003070288...........................  Nippon Kayaku Company, Ltd.
EX2003070293...........................  Nippon Kayaku Company, Ltd.
EX2003080080...........................  Dyno Nobel, Inc.
EX2003100075...........................  Ensign-Bickford Aerospace &
                                          Defense Company.
EX2003100323...........................  Delta Caps Canada.
EX2003120602...........................  Schlumberger.
EX2004030230...........................  Nippon Kayaku Company, Ltd.
EX2004030230A..........................  Nippon Kayaku Company, Ltd.
EX2004030231...........................  Nippon Kayaku Company, Ltd.
EX2004030231A..........................  Nippon Kayaku Company, Ltd.
EX2004030262...........................  QuietSplit, Inc.
EX2004050396...........................  Dyno Nobel, Inc.
EX2004060022...........................  Orica Canada, Inc.
EX2004060107...........................  Cesaroni Technology, Inc.
EX2004070192...........................  Headquarters 1st Joint Movement
                                          Group.
EX2004070194...........................  Headquarters 1st Joint Movement
                                          Group.
EX2004080006...........................  Nippon Kayaku Company, Ltd.
EX2004080006A..........................  Nippon Kayaku Company, Ltd.
EX2004100158...........................  Nippon Kayaku Company, Ltd.
EX2004100158A..........................  Nippon Kayaku Company, Ltd.
EX2004100162...........................  Daicel Safety Systems, Inc.
EX2004100162A..........................  Daicel Safety Systems, Inc.
EX2004100166...........................  Daicel Safety Systems, Inc.
EX2004100166A..........................  Daicel Safety Systems, Inc.
EX2004100167...........................  Daicel Safety Systems, Inc.
EX2004100167A..........................  Daicel Safety Systems, Inc.
EX2004110267...........................  Dyno Nobel, Inc.
EX2004110284...........................  Yulim Materials Company, Ltd.
EX2005010241...........................  LifeSparc.
EX2005010241A..........................  LifeSparc.
EX2005020022...........................  Yamato Protec Corporation.
EX2005030178...........................  Companhia Brasileira de
                                          Cartuchos.
EX2005040440...........................  Aircraft Interior Products
                                          Goodrich Corporation.
EX2005040499...........................  Daicel Safety Systems, Inc.
EX2005040537...........................  Daicel Safety Systems, Inc.
EX2005070111...........................  Kidde Technologies, Inc.
EX2005070130...........................  Dyno Nobel, Inc.
EX2005070342...........................  Nippon Kayaku Co., Ltd.
EX2005070342A..........................  Nippon Kayaku Co., Ltd.
EX2005070343...........................  Nippon Kayaku Co., Ltd.
EX2005070343A..........................  Nippon Kayaku Co., Ltd.
EX2005080084...........................  LifeSparc.
EX2005090499...........................  Dyno Nobel, Inc.
EX2005100016...........................  PC International, Inc.
EX2005100169...........................  Explosivos Mexicanos, S.A. de
                                          C.V.
EX2005120064...........................  Nippon Kayaku Company, Ltd.
EX2005120064A..........................  Nippon Kayaku Company, Ltd.
EX2006010052...........................  German Armed Forces Command USA/
                                          CA.
EX2006020113...........................  Pains Wessex Chemring
                                          Countermeasures.

EX2006040305...........................  Nippon Kayaku Co. Ltd.
EX2006040305A..........................  Nippon Kayaku Co. Ltd.
EX2006050221...........................  Cooper Power Systems Inc.
EX2006060079...........................  Total Mission.
EX2006060080...........................  Total Mission.
EX2006070022...........................  Schlumberger Reservoir
                                          Completions.
EX2006070240...........................  Hubbell Power Systems.
EX2006090244...........................  Raytheon Missile Systems.
EX2007010612...........................  International Launch Services.
EX2007030074...........................  Embassy of Japan.
EX2007030076...........................  Embassy of Japan.
EX2007030077...........................  Embassy of Japan.
EX2007030078...........................  Embassy of Japan.
EX2007030079...........................  Embassy of Japan.
EX2007030081...........................  Embassy of Japan.
EX2007030083...........................  Embassy of Japan.
EX2007040043...........................  LifeSparc.
EX2007040120...........................  Embassy of Japan.
EX2007050120...........................  Raytheon Missile Systems.
EX2007050122...........................  Pacific Scientific.
EX2007050305...........................  Orica USA, Inc.
EX2007060050...........................  Aerojet General Corporation--
                                          Redmond Operations.
EX2007070083...........................  Nippon Kayaku Co., Ltd.
EX2007070084...........................  Nippon Kayaku Co., Ltd.
EX2007080023...........................  Nippon Kayaku Co., Ltd.
EX2007080024...........................  Nippon Kayaku Co., Ltd.
EX2007080367...........................  Nippon Kayaku Co., Ltd.
EX2007080368...........................  Nippon Kayaku Co., Ltd.
EX2007110031...........................  Pacific Scientific.
EX2007120429...........................  Martin-Baker Aircraft Co. Ltd.
EX2008010381...........................  Defence Equipment & Support.
EX2008010386...........................  Defence Equipment & Support.
EX2008010387...........................  Defence Equipment & Support.
EX2008010412...........................  LOGOS Imaging LLC.
EX2008020494...........................  Kidde Technologies, Inc.--Kidde
                                          Aerospace.
EX2008040011...........................  LifeSparc, Inc.
EX2008040023...........................  German Armed Forces Command USA/
                                          CA.
EX2008040033...........................  elp European Logistics Partners
                                          GmbH.
EX2008040083...........................  Special Devices, Inc.
EX2008040204...........................  Goodrich Corporation.
EX2008050062...........................  Orica Canada, Inc.
EX2008050350...........................  Martin-Baker.
EX2008060030...........................  Lifesparc, Inc.
EX2008060098...........................  Defence Equipment and Support.
EX2008060099...........................  Defence Equipment and Support.
EX2008060257...........................  Dyno Nobel.
EX2008070080...........................  Kuwait Air Force.
EX2008120002...........................  Daicel Safety Technologies
                                          Thailand Co., Ltd.
EX2008120003...........................  Daicel Safety Technologies
                                          Thailand Co., Ltd.
EX2008120004...........................  Daicel Safety Systems
                                          (Thailand) Company Ltd.
EX2008120005...........................  Daicel Safety Systems, Inc.
EX2009050654...........................  ELP GmbH European Logistic
                                          Partners.
EX2009090077...........................  Universal Propulsion Company,
                                          Inc.
EX2009100152...........................  Defence Equipment and Support.
------------------------------------------------------------------------

    Issued in Washington, DC, on October 27, 2015 under authority
delegated in 49 CFR Part 107.
Magdy El-Sibaie,
Associate Administrator for Hazardous Materials Safety, Pipeline and
Hazardous Materials Safety Administration.
[FR Doc. 2015-27784 Filed 10-30-15; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 87, Number 133 (Wednesday, July 13, 2022)]
[Rules and Regulations]
[Pages 41590-41592]
[FR Doc No: 2022-14895]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0594]
RIN 1625-AA00

Safety Zone; Military Exercise, Sinclair Inlet, Bremerton, WA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zones for
navigable waters within a 500 yard radius of a position located in
Sinclair Inlet, Bremerton, WA. The safety zone is needed to protect
personnel, vessels, and the marine environment from potential hazards
created by a military exercise involving helocast operations. Entry of
vessels or persons into this zone is prohibited unless specifically
authorized by the Captain of the Port Puget Sound.

DATES: This rule is effective from 10:30 a.m. on August 4, 2022 through
11:30 a.m. on August 5, 2022.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0594 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Chief Warrant Officer, William Martinez, Sector Puget
Sound Waterways Management Division, U.S. Coast Guard; telephone 206-
217-6048, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Puget Sound
DHS Department of Homeland Security

FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. The Coast Guard
was notified of the military exercise on July 5, 2022, and due to the
evolving dynamic nature of the military helocast exercise it was
determined on July 5, 2022 that immediate action is needed to respond
to the potential safety hazards associated with the exercise. The
Captain of the Port Puget Sound (COTP) determined this regulation is
necessary to ensure the safety of personnel, vessels, and the marine
environment. The Coast Guard lacks sufficient time to request public
comments and then consider those comments before issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable because this regulation is needed to
respond to the potential safety hazards associated with this military
exercise.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The COTP has determined that
potential hazards associated with the military helocast exercise on
August 4, 2022 and August 5, 2022, will be a safety concern for anyone
within a 500-yard radius of position 47[deg]32'51.5'' N 122[deg]38'37''
W and the exercise participants. This rule is needed to protect
personnel, vessels, and the marine environment in the navigable waters
within the safety zone.

IV. Discussion of the Rule

    This rule establishes a safety zone from 10:30 until 11:30 a.m. on
August 4, 2022 and 10:30 until 11:00 a.m. on August 5, 2022. The safety
zone will cover all navigable waters within a 500 yard radius of
position 47[deg]32'51.5'' N 122[deg]38'37'' W in Sinclair Inlet. This
helocast exercise involves helicopters flying at a low altitude above
the water and launching boats and personnel from the aircraft. The
duration of the zone is intended to protect personnel, vessels, and the
marine environment in these navigable waters while the exercise is
ongoing. No vessel or person will be permitted to enter the safety zone
without obtaining permission from the COTP or a designated
representative.

V. 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 and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on size, location,
and duration of the safety zone. Vessel traffic will be able to safely
transit around this safety zone which would impact a small designated
area of the Puget Sound for 1 hour on two days. The Coast Guard will
transmit a Broadcast Notice to Mariners via VHF-FM marine channel 16
regarding the safety zone enforcement and publish in the Local Notice
to Mariners information about details of the safety zone. In addition,
the rule allows mariners to seek permission to enter the zone. To seek
permission to enter, contact the COTP or the COTP's representative by
VHF Channel 16. Those in the safety zone must comply with all lawful
orders or directions given to them by the COTP or the COTP's designated
representative.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 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.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    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
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    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.

C. 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).

D. Federalism and Indian Tribal Governments

    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 have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, 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.

E. 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.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(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 a
stationary safety zone lasting only 1 hour per day that will prohibit
entry within a 500 yard radius of position 47[deg]32'51.5'' N
122[deg]38'37'' W in Sinclair Inlet. It is categorically excluded from
further review under paragraph L60(a) of Appendix A, Table 1 of DHS
Instruction Manual 023-01-001-01, Rev. 1.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email 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.

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T13-0594 to read as follows:

Sec.  165.T13-0594  Safety Zone; Military Exercise, Sinclair Inlet,
Bremerton, WA.

    (a) Location. The following area is a safety zone: all navigable
waters within a 500 yard radius of position 47[deg]32'51.5'' N
122[deg]38'37'' W in Sinclair Inlet. These coordinates are based 1984
World Geodetic System (WGS 84).
    (b) Definitions. As used in this section, a designated
representative means a Coast Guard Patrol Commander, including a Coast
Guard coxswain, petty officer, or other officer operating a Coast Guard
vessel and a Federal, State, and local officer designated by or
assisting the Captain of the Port Puget Sound (COTP) in the enforcement
of the safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by VHF Channel 16. Those in the safety zone must comply
with all lawful orders or directions given to them by the COTP or the
COTP's designated representative.
    (d) Enforcement period. This section will be enforced from 10:30
until 11:30 a.m. on August 4, 2022 and 10:30 until 11:30 a.m. on August
5, 2022.

    Dated: July 7, 2022.
P.M. Hilbert,
Captain, U.S. Coast Guard, Captain of the Port Puget Sound.
[FR Doc. 2022-14895 Filed 7-12-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 127 (Thursday, July 2, 2015)]
[Proposed Rules]
[Pages 38145-38147]
[FR Doc No: 2015-16367]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 601

[Docket No. FDA-2015-N-2103]

Removal of Review and Reclassification Procedures for Biological
Products Licensed Prior to July 1, 1972

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA) proposes to remove two
regulations that prescribe procedures for FDA's review and
classification of biological products licensed before July 1, 1972. FDA
is taking this action because the two regulations are obsolete and no
longer necessary in light of other statutory and regulatory authorities
established since 1972, which allow FDA to evaluate and monitor the
safety and effectiveness of all biological products. In addition, other
statutory and regulatory authorities authorize FDA to revoke a license
for products because they are not safe and effective, or are
misbranded. FDA is taking this action as part of its retrospective
review of its regulations to promote improvement and innovation.

DATES: Submit either written or electronic comments on the proposed
rule by September 30, 2015.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No.
FDA-2015-N-2103 for this rulemaking. All comments received may be
posted without change to http://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301,

Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Proposed Rule

    FDA proposes to remove two regulations that prescribe procedures
for FDA's review and classification of biological products licensed
before July 1, 1972, because the two regulations are obsolete and no
longer necessary in light of other statutory and regulatory authorities
established since 1972. These other statutory and regulatory
authorities allow FDA to evaluate and monitor the safety and
effectiveness of all biological products and authorize FDA to revoke a
license for products because they are not safe and effective, or are
misbranded.

Statement of Legal Authority

    FDA is taking this action under the biological products provisions
of the Public Health Service Act (the PHS Act), and the drugs and
general administrative provisions of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act).

Summary of the Major Provisions of the Proposed Rule

    The proposed rule removes Sec. Sec.  601.25 and 601.26 (21 CFR
601.25 and 601.26), which prescribe procedures for FDA's review and
classification of biological products licensed before July 1, 1972.

Costs and Benefits

    Because this proposed rule would not impose any additional
regulatory burdens, this regulation is not anticipated to result in any
compliance costs and the economic impact is expected to be minimal.

I. Background

    In the Federal Register of March 15, 1972 (37 FR 5404), the
Director of the National Institutes of Health (NIH) announced that the
Division of Biologics Standards, NIH would review the effectiveness of
all licensed biologicals. In the Federal Register of June 29, 1972 (37
FR 12865), FDA announced the transfer of regulatory authority of
biological products from the Division of Biologics Standards, NIH to
FDA. After obtaining regulatory authority of biological products, the
Commissioner of FDA proposed procedures for reviewing the safety,
effectiveness, and labeling of all biological products licensed at the
time of the transfer, including biological products licensed before
July 1, 1972 (37 FR 16679, August 18, 1972). The procedures for review
of biological products licensed before July 1, 1972, were codified in
21 CFR 273.245 (38 FR 4319 at 4321, February 13, 1973) and later
redesignated to Sec.  601.25 (38 FR 32048, November 20, 1973). The
procedures for review of biological products licensed before July 1,
1972, were supplemented by procedures codified in Sec.  601.26 (47 FR
44062, October 5, 1982).

II. Current Methods for Ensuring the Safety and Effectiveness of
Biological Products

    Since providing the procedures under Sec. Sec.  601.25 and 601.26,
FDA established many new regulations to assess and ensure the safety
and efficacy of biological products. FDA established the Current Good
Manufacturing Practice (cGMP) regulations, which contains the minimum
current good manufacturing practice for preparation of drug products,
including biological products. The cGMP regulations help FDA ensure
that such products meet the requirements for product safety,
effectiveness, and labeling. FDA also ensures the safety and
effectiveness of biological products through application of other
regulations, such as the reporting of biological product deviations by
licensed manufacturers (see 21 CFR 600.14), postmarketing reporting of
adverse experiences (21 CFR 600.80), and labeling regulations (for
example, 21 CFR part 201). Biological products that do not meet the
requirements under these regulations are subject to license revocation
under Sec.  601.5, which allows FDA to revoke any biologics license for
a product that fails to meet applicable standards and comply with
regulations designed to ensure the safety, purity, and potency of the
licensed product, and that the product is not misbranded.
    In addition, FDA continues to ensure the safety and effectiveness
of licensed biological products through the development and application
of additional standards and mechanisms. These mechanisms assist FDA in
evaluating and monitoring the safety and effectiveness of biological
products.

III. Description of the Proposed Rule

    The proposed rule removes Sec. Sec.  601.25 and 601.26 of the
regulations, which prescribe procedures for FDA's review and
classification of biological products licensed before July 1, 1972. FDA
is taking this action because these regulations are obsolete and no
longer necessary in light of other statutory and regulatory authorities
established since 1972, which allows FDA to evaluate and monitor the
safety and effectiveness of all biological products.

IV. Legal Authority

    FDA is issuing this regulation under the biological products
provisions of the PHS Act (42 U.S.C. 262 and 264) and the drugs and
general administrative provisions of the FD&C Act (sections 201, 301,
501, 502, 503, 505, 510, 701, and 704) (21 U.S.C. 321, 331, 351, 352,
353, 355, 360, 371, and 374). Under these provisions of the PHS Act and
the FD&C Act, we have the authority to issue and enforce regulations
designed to ensure that biological products are safe, pure, and potent;
and to prevent the introduction, transmission, and spread of
communicable disease.

V. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this proposed rule is not a
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the rule proposes to remove regulations that
are obsolete and no longer necessary in light of other current
statutory and regulatory authorities, the Agency proposes to certify
that the final rule will not have a significant economic impact on a
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $144 million, using the most current (2014) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.

VI. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
adverse effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

VII. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would not contain policies that would
have substantial direct effects 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.
Accordingly, the Agency tentatively concludes that the proposed rule
does not contain policies that have federalism implications as defined
in the Executive Order and, consequently, a federalism summary impact
statement is not required.

VIII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by OMB under the
Paperwork Reduction Act of 1995 is not required.

IX. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

List of Subjects in 21 CFR Part 601

    Administrative practice and procedure, Biologics, Confidential
business information.

    Therefore, under the FD&C Act, the PHS Act, and under authority
delegated to the Commissioner of Food and Drugs, it is proposed that 21
CFR part 601 be 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).

Sec.  601.25  [Removed]

0
2. Remove Sec.  601.25.

Sec.  601.26  [Removed]

0
3. Remove Sec.  601.26.

    Dated: June 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16367 Filed 7-1-15; 8:45 am]
BILLING CODE 4164-01-P