[Federal Register Volume 79, Number 238 (Thursday, December 11, 2014)]
[Notices]
[Pages 73616-73617]
[FR Doc No: 2014-29016]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2014-0002]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final notice.

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

SUMMARY: New or modified Base (1-percent annual chance) Flood
Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA)
boundaries or zone designations, and/or regulatory floodways
(hereinafter referred to as flood hazard determinations) as shown on
the indicated Letter of Map Revision (LOMR) for each of the communities
listed in the table below are finalized. Each LOMR revises the Flood
Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance
Study (FIS) reports, currently in effect for the listed communities.
The flood hazard determinations modified by each LOMR will be used to
calculate flood insurance premium rates for new buildings and their
contents.

DATES: The effective date for each LOMR is indicated in the table
below.

ADDRESSES: Each LOMR is available for inspection at both the respective
Community Map Repository address listed in the table below and online
through the FEMA Map Service Center at www.msc.fema.gov.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final flood hazard determinations as shown in the
LOMRs for each community listed in the table below. Notice of these
modified flood hazard determinations has been published in newspapers
of local circulation and 90 days have elapsed since that publication.
The Deputy Associate Administrator for Mitigation has resolved any
appeals resulting from this notification.
    The modified flood hazard determinations are made pursuant to
section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4105, and are in accordance with the National Flood Insurance Act of
1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.
    For rating purposes, the currently effective community number is
shown and must be used for all new policies and renewals.
    The new or modified flood hazard information is the basis for the
floodplain management measures that the community is required either to
adopt or to show evidence of being already in effect in order to remain
qualified for participation in the National Flood Insurance Program
(NFIP).
    This new or modified flood hazard information, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities.
    This new or modified flood hazard determinations are used to meet
the floodplain management requirements of the NFIP and also are used to
calculate the appropriate flood insurance premium rates for new
buildings, and for the contents in those buildings. The changes in
flood hazard determinations are in accordance with 44 CFR 65.4.
    Interested lessees and owners of real property are encouraged to
review the final flood hazard information available at the address
cited below for each community or online through the FEMA Map Service
Center at www.msc.fema.gov.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: November 24, 2014.
Roy E. Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Chief executive
         State and county           Location and case No.       officer of        Community map repository   Effective date of modification   Community
                                                                 community                                                                       No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Jersey: Sussex (FEMA Docket     Township of Byram (14- The Honorable James   Byram Township, Municipal  October 2, 2014................       340557
 No.: B-1424).                       02-1064P).             Oscovitch, Mayor,     Building, 10 Mansfield
                                                            Township of Byram,    Drive, Stanhope, NJ
                                                            10 Mansfield Drive,   07874.
                                                            Stanhope, NJ 07874.
New York:
    Rockland, (FEMA Docket No.: B-  Town of Ramapo (13-02- The Honorable         Town of Ramapo,            October 16, 2014...............       365340
     1422).                          1859P).                Christopher P. St.    Department of Public
                                                            Lawrence,             Works, 16 Pioneer
                                                            Supervisor, Town of   Avenue, Tallman, NY
                                                            Ramapo, 237 Route     10982.
                                                            59, Suffern, NY
                                                            10901.
    Rockland (FEMA Docket No.: B-   Village of Hillburn    The Honorable Craig   Village Hall, 31 Mountain  October 16, 2014...............       360683
     1422).                          (13-02-1859P).         M. Flanagan, Jr.,     Avenue, Hillburn, NY
                                                            Mayor, Village of     10931.
                                                            Hillburn, 31
                                                            Mountain Avenue,
                                                            Hillburn, NY 10931.
Oklahoma:

    Carter (FEMA Docket No.: B-     City of Ardmore (13-   The Honorable Martin  Developmental Services     October 17, 2014...............       400031
     1432).                          06-4203P).             Dyer, Mayor, City     Department, 23 South
                                                            of Ardmore, P.O.      Washington Street,
                                                            Box 249, Ardmore,     Ardmore, OK 73401.
                                                            OK 73402.
    Oklahoma (FEMA Docket No.: B-   City of Oklahoma City  The Honorable Mick    420 West Main Street,      October 9, 2014................       405378
     1424).                          (14-06-0267P).         Cornett, Mayor,       Suite 700, Oklahoma
                                                            City of Oklahoma      City, OK 73102.
                                                            City, 200 North
                                                            Walker Avenue, 3rd
                                                            Floor, Oklahoma
                                                            City, OK 73102.
Pennsylvania:
    Mercer (FEMA Docket No.: B-     Borough of             Mr. Kenneth P.        1 South Walnut Street,     October 22, 2014...............       420682
     1432).                          Sharpsville (14-03-    Robertson, Manager,   Sharpsville, PA 16150.
                                     2041P).                Borough of
                                                            Sharpsville, 1
                                                            South Walnut
                                                            Street,
                                                            Sharpsville, PA
                                                            16150.
    Mercer (FEMA Docket No.: B-     City of Hermitage (14- Mr. Gary P. Hinkson,  800 North Hermitage Road,  October 22, 2014...............       421862
     1432).                          03-2041P).             Manager, City of      Hermitage, PA 16148.
                                                            Hermitage, 800
                                                            North Hermitage
                                                            Road, Hermitage, PA
                                                            16148.
    Mercer (FEMA Docket No.: B-     Township of South      The Honorable Brian   Township of South          October 22, 2014...............       421876
     1432).                          Pymatuning (14-03-     Geisel, Chairman,     Pymatuning, 3483
                                     2041P).                Township of South     Tamarack Drive,
                                                            Pymatuning Board of   Sharpsville, PA 16150.
                                                            Supervisors, 3483
                                                            Tamarack Drive,
                                                            Sharpsville, PA
                                                            16150.
Texas:
    Denton (FEMA Docket No.: B-     Town of Flower Mound   The Honorable Thomas  Engineering Department,    October 14, 2014...............       480777
     1432).                          (14-06-0182P).         Hayden, Mayor, Town   1001 Cross Timbers Road,
                                                            of Flower Mound,      Suite 3220, Flower
                                                            2121 Cross Timbers    Mound, TX 75028.
                                                            Road, Flower Mound,
                                                            TX 75028.
    Harris (FEMA Docket No.: B-     City of Houston (14-   The Honorable Annise  Public Works and           October 6, 2014................       480296
     1424).                          06-1647P).             D. Parker, Mayor,     Engineering Department,
                                                            City of Houston,      611 Walker Street,
                                                            P.O. Box 1562,        Houston, TX 77002.
                                                            Houston, TX 77251.
    Harris (FEMA Docket No.: B-     Unincorporated areas   The Honorable Ed M.   Harris County, 10555       October 10, 2014...............       480287
     1424).                          of Harris County (14-  Emmett, Harris        Northwest Freeway,
                                     06-1080P).             County Judge, 1001    Houston, TX 77092.
                                                            Preston Street,
                                                            Suite 911, Houston,
                                                            TX 77002.
    Harris (FEMA Docket No.: B-     Unincorporated areas   The Honorable Ed M.   Harris County, 10555       October 6, 2014................       480287
     1424).                          of Harris County (14-  Emmett, Harris        Northwest Freeway,
                                     06-1647P).             County Judge, 1001    Houston, TX 77092.
                                                            Preston Street,
                                                            Suite 911, Houston,
                                                            TX 77002.
    Harris (FEMA Docket No.: B-     Unincorporated areas   The Honorable Ed M.   Harris County, 10555       October 3, 2014................       480287
     1424).                          of Harris County (14-  Emmett, Harris        Northwest Freeway,
                                     06-1656P).             County Judge, 1001    Houston, TX 77092.
                                                            Preston Street,
                                                            Suite 911, Houston,
                                                            TX 77002.
    Kendall (FEMA Docket No.: B-    Unincorporated areas   The Honorable Darrel  Kendall County             October 6, 2014................       480417
     1432).                          of Kendall County      L. Lux, Kendall       Development and
                                     (13-06-4074P).         County Judge, 201     Floodplain Management
                                                            East San Antonio      Office, 201 East San
                                                            Avenue, Suite 122,    Antonio Avenue, Suite
                                                            Boerne, TX 78006.     101, Boerne, TX 78006.
    McLennan (FEMA Docket No.: B-   City of Robinson (13-  The Honorable Bryan   City Hall, 111 West        October 8, 2014................       480460
     1424).                          06-4191P).             Ferguson, Mayor,      Lyndale Drive, Robinson,
                                                            City of Robinson,     TX 76706.
                                                            111 West Lyndale
                                                            Drive, Robinson, TX
                                                            76706.
    Tarrant (FEMA Docket No.: B-    City of Colleyville    The Honorable David   Engineering Division, 100  September 17, 2014.............       480590
     1432).                          (13-06-4370P).         Kelly, Mayor, City    Main Street, 2nd Floor,
                                                            of Colleyville, 100   Colleyville, TX 76034.
                                                            Main Street,
                                                            Colleyville, TX
                                                            76034.
    Tarrant (FEMA Docket No.: B-    City of Keller (13-06- The Honorable Mark    City Hall, 1100 Bear       September 17, 2014.............       480602
     1432).                          4370P).                Mathews, Mayor,       Creek Parkway, Keller,
                                                            City of Keller,       TX 76248.
                                                            P.O. Box 770,
                                                            Keller, TX 76244.
    Tarrant (FEMA Docket No.: B-    City of Mansfield (14- The Honorable David   City Hall, 1200 East       October 6, 2014................       480606
     1432).                          06-0939P).             L. Cook, Mayor,       Broad Street, Mansfield,
                                                            City of Mansfield,    TX 76063.
                                                            1200 East Broad
                                                            Street, Mansfield,
                                                            TX 76063.
    Tarrant (FEMA Docket No.: B-    City of Southlake (13- The Honorable John    Public Works               September 17, 2014.............       480612
     1432).                          06-4370P).             Terrell, Mayor,       Administration and
                                                            City of Southlake,    Engineering, 1400 Main
                                                            1400 Main Street,     Street, Suite 320,
                                                            Suite 270,            Southlake, TX 76092.
                                                            Southlake, TX 76092.
    Travis (FEMA Docket No.: B-     City of Lakeway (13-   The Honorable Dave    Floodplain                 October 17, 2014...............       481303
     1432).                          06-4373P).             DeOme, Mayor, City    Administrator's Office,
                                                            of Lakeway, 1102      1102 Lohmans Crossing
                                                            Lohmans Crossing      Road, Lakeway, TX 78734.
                                                            Road, Lakeway, TX
                                                            78734.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2014-29016 Filed 12-10-14; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 82, Number 70 (Thursday, April 13, 2017)]
[Notices]
[Pages 17841-17844]
[FR Doc No: 2017-07468]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1610]

Medical Devices; Exemptions From Premarket Notification: Class I
Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
identified a list of class I devices that are now exempt from premarket
notification requirements, subject to certain limitations. FDA is
publishing this notice of that determination in accordance with
procedures established by the 21st Century Cures Act. This notice
represents FDA's final determination with respect to the class I
devices included in this document. FDA's action will decrease
regulatory burdens on the medical device industry and will eliminate
private costs and expenditures required to comply with certain Federal
regulation.

FOR FURTHER INFORMATION CONTACT: Bryce Bennett, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Under section 513 of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three
regulatory classes: Class I, class II, or class III. FDA classification
of a device is determined by the amount of regulation necessary to
provide a reasonable assurance of safety and effectiveness. Under the
Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295),
and the Safe Medical Devices Act of 1990 (Pub. L. 101-629), devices are
classified into class I (general controls) if there is information
showing that the general controls of the FD&C Act are sufficient to
assure safety and effectiveness; into class II (special controls), if
general controls, by themselves, are insufficient to provide reasonable
assurance of safety and effectiveness, but there is sufficient
information to establish special controls to provide such assurance;
and into class III (premarket approval), if there is insufficient
information to support classifying a device into class I or class II
and the device is a life sustaining or life supporting device, or is
for a use which is of substantial importance in preventing impairment
of human health, or presents a potential unreasonable risk of illness
or injury.
    Most generic types of devices that were on the market before the
date of the 1976 amendments (May 28, 1976) (generally referred to as
preamendments devices) have been classified by FDA under the procedures
set forth in section

513(c) and (d) of the FD&C Act through the issuance of classification
regulations into one of these three regulatory classes. Devices
introduced into interstate commerce for the first time on or after May
28, 1976 (generally referred to as postamendments devices), are
classified through the premarket notification process under section
510(k) of the FD&C Act (21 U.S.C. 360(k)). Section 510(k) of the FD&C
Act and the implementing regulations, part 807 of Title 21 of the Code
of Federal Regulations (CFR), require persons who intend to market a
new device to submit a premarket notification (510(k)) containing
information that allows FDA to determine whether the new device is
``substantially equivalent'' within the meaning of section 513(i) of
the FD&C Act to a legally marketed device that does not require
premarket approval.
    The 21st Century Cures Act (Pub. L. 114-255) was signed into law on
December 13, 2016. Section 3054 of that Act amended section 510(l) of
the FD&C Act. As amended, section 510(l)(2) of the FD&C Act requires
FDA to identify through publication in the Federal Register, any type
of class I device that the Agency determines no longer requires a
report under section 510(k) of the FD&C Act to provide reasonable
assurance of safety and effectiveness. FDA is required to publish this
determination within 120 days of the date of enactment of the 21st
Century Cures Act and at least once every 5 years thereafter, as FDA
determines appropriate. Section 510(l)(2) further provides that upon
the date of publication of the Agency's determination in the Federal
Register, a 510(k) will no longer be required for these devices and the
classification regulation applicable to each such type of device shall
be deemed amended to incorporate such exemption. In a final action, FDA
intends to amend the codified language for each listed classification
regulation to reflect the final determination with respect to 510(k)
exemption. FDA's action will decrease regulatory burdens on the medical
device industry and will eliminate private costs and expenditures
required to comply with certain Federal regulation. Specifically,
regulated industry will no longer have to invest time and resources in
510(k) submissions for certain class I devices, including preparation
of documents and data for submission to FDA, payment of user fees
associated with 510(k) submissions, and responding to questions and
requests for additional information from FDA during 510(k) review.

II. Criteria for Exemption

    As stated previously, section 3054 of the 21st Century Cures Act
amended section 510(l) of the FD&C Act. In doing so, the amendments
reorganized section 510(l) into subsections 510(l)(1) and (2). As such,
subsection 510(l)(1) provides that a class I device is exempt from the
premarket notification requirements under section 510(k) of the FD&C
Act, unless the device is intended for a use which is of substantial
importance in preventing impairment of human health or it presents a
potential unreasonable risk of illness or injury (hereafter ``reserved
criteria''). Based on these reserved criteria, FDA has evaluated all
class I devices to determine which device types should be exempt from
premarket notification requirements. In developing the list of exempt
devices, the Agency considered its experience in reviewing premarket
notifications for these devices, focusing on the risk inherent with the
device and the disease being treated or diagnosed (e.g., devices with
rapidly evolving technology or expansions of intended uses). The Agency
also considered the history of adverse event reports under the medical
device reporting program for these devices, as well as their history of
product recalls. Following these considerations, FDA reached the final
determination that the devices listed in table 1 do not meet the
reserved criteria in that they are not intended for a use that is of
substantial importance in preventing impairment of human health or
present a potential unreasonable risk of illness or injury.

III. Limitations on Exemptions

    FDA believes that the types of class I devices listed in this
notice should be exempt from the premarket notification requirements
found under section 510(k) of the FD&C Act. However, an exemption from
the requirement of premarket notification does not mean that the device
is exempt from any other statutory or regulatory requirements, unless
such exemption is explicitly provided by order or regulation. FDA's
determination that premarket notification is unnecessary to provide a
reasonable assurance of safety and effectiveness for devices listed in
this document is based, in part, on the assurance of safety and
effectiveness that other regulatory controls, such as current good
manufacturing practice requirements, provide.
    In addition to being subject to the general limitations to the
exemptions found in 21 CFR 862.9, 864.9, 866.9, 872.9, 876.9, 878.9,
880.9, 882.9, 884.9 and 886.9, FDA may also partially limit the
exemption from premarket notification requirements to specific devices
within a listed device type. In table 1, for example, FDA lists the
exemption of the ataxiagraph device as 510(k) exempt, but limits the
exemption to such devices that do not provide an interpretation or a
clinical implication of the measurement. All other ataxiagraph devices
are still subject to premarket notification requirements because FDA
determined that premarket notification is necessary to provide a
reasonable assurance of safety and effectiveness for these devices.

IV. List of Class I Devices

    FDA is identifying the following list of class I devices that no
longer require premarket notification under section 510(k) of the FD&C
Act, subject to the general limitations to the exemptions:

                        Table 1--Class I Devices
------------------------------------------------------------------------
                                                             Partial
                                             Product        exemption
    21 CFR section         Device type         code      limitation  (if
                                                           applicable)
------------------------------------------------------------------------
862.1410..............  Bathophenanthroli  CFM          ................
                         ne, Colorimetry,
                         Iron (Non-Heme).
862.1410..............  Photometric        JIY          ................
                         Method, Iron
                         (Non-Heme).
862.1410..............  Atomic             JIZ          ................
                         Absorption, Iron
                         (Non-Heme).
862.1410..............  Radio-Labeled      JJA          ................
                         Iron Method,
                         Iron (Non-Heme).
862.1415..............  Ferrozine          JMO          ................
                         (Colorimetric)
                         Iron Binding
                         Capacity.
862.1415..............  Resin, Ion-        JQD          ................
                         Exchange,
                         Thioglycolic
                         Acid,
                         Colorimetry,
                         Iron Binding
                         Capacity.
862.1415..............  Resin, Ion-        JQE          ................
                         Exchange,
                         Ascorbic Acid,
                         Colorimetry,
                         Iron Binding
                         Capacity.
862.1415..............  Bathophenanthroli  JQF          ................
                         ne, Iron Binding
                         Capacity.
862.1415..............  Radiometric,       JQG          ................
                         Fe59, Iron
                         Binding Capacity.

862.1580..............  Phosphomolybdate   CEO          ................
                         (Colorimetric),
                         Inorganic
                         Phosphorus.
862.1660..............  Electrolyte        JJR          ................
                         Controls
                         (Assayed and
                         Unassayed).
862.1660..............  Controls For       JJS          ................
                         Blood-Gases,
                         (Assayed and
                         Unassayed).
862.1660..............  Enzyme Controls    JJT          ................
                         (Assayed and
                         Unassayed).
862.1660..............  Urinalysis         JJW          ................
                         Controls
                         (Assayed and
                         Unassayed).
862.1660..............  Single             JJX          Exemption is
                         (Specified)                     limited to
                         Analyte Controls                controls not
                         (Assayed and                    intended for
                         Unassayed).                     use in donor
                                                         screening
                                                         tests.
862.1660..............  Multi-Analyte      JJY          Exemption is
                         Controls, All                   limited to
                         Kinds (Assayed).                controls not
                                                         intended for
                                                         use in donor
                                                         screening
                                                         tests.
862.1660..............  Tonometer          LCH          ................
                         (Calibration and
                         Q.C. of Blood-
                         Gas
                         Instruments),
                         Clinical.
862.1660..............  Kit, Serological,  MJX          Exemption is
                         Positive Control.               limited to
                                                         controls not
                                                         intended for
                                                         use in donor
                                                         screening
                                                         tests.
862.1660..............  Kit, Serological,  MJY          Exemption is
                         Negative Control.               limited to
                                                         controls not
                                                         intended for
                                                         use in donor
                                                         screening
                                                         tests.
862.1660..............  Kit, Direct        MJZ          Exemption is
                         Antigen,                        limited to
                         Positive Control.               controls not
                                                         intended for
                                                         use in donor
                                                         screening
                                                         tests.
862.1660..............  Kit, Direct        MKA          Exemption is
                         Antigen,                        limited to
                         Negative Control.               controls not
                                                         intended for
                                                         use in donor
                                                         screening
                                                         tests.
862.1775..............  Acid, Uric,        CDH          ................
                         Phosphotungstate
                         Reduction.
862.1775..............  Acid, Uric,        CDO          ................
                         Uricase (U.V.).
862.1775..............  Acid, Uric,        JHA          ................
                         Uricase
                         (Gasometric).
862.1775..............  Acid, Uric,        JHC          ................
                         Uricase (Oxygen
                         Rate).
862.1775..............  Acid, Uric, Acid   LFQ          ................
                         Reduction of
                         Ferric Ion.
862.3050..............  Devices, Breath    DJZ          ................
                         Trapping,
                         Alcohol.
862.3220..............  Spectral Absorb.   JKS          ................
                         Curve,
                         Oxyhemoglobin,
                         Carboxyhemoglobi
                         n, Carbon-
                         Monoxide.
862.3220..............  Gas                JKT          ................
                         Chromatograph,
                         Carbon-Monoxide.
862.3220..............  Enzyme             MKU          ................
                         Immunoassasy,
                         Nocotine and
                         Nicotine
                         Metabolites.
862.3240..............  Cholinesterase     DIG          ................
                         Test Paper.
862.3240..............  Colorimetry,       DIH          ................
                         Cholinesterase.
862.3240..............  Acetylcholine      DLI          ................
                         Chloride,
                         Specific Reagent
                         for Pseudo
                         Cholinesterase.
862.3240..............  Solution, M-       DMR          ................
                         Nitrophenol,
                         Specific Reagent
                         for
                         Cholinesterase.
862.3240..............  Electrometry,      DOH          ................
                         Cholinesterase.
862.3280..............  Heavy Metals       DIE          ................
                         Control
                         Materials.
862.3280..............  Drug Mixture       DIF          ................
                         Control
                         Materials.
862.3280..............  Digitoxin Control  DJK          ................
                         Serum, Ria.
862.3280..............  Alcohol Control    DKC          ................
                         Materials.
862.3280..............  Digoxin Control    DMP          ................
                         Serum, Ria.
862.3280..............  Drug Specific      LAS          ................
                         Control
                         Materials.
862.3280..............  Theophylline       LAW          ................
                         Control
                         Materials.
862.3280..............  Lidocaine Control  LAX          ................
                         Materials.
862.3280..............  Methotrexate       LAY          ................
                         Control
                         Materials.
862.3280..............  N-                 LAZ          ................
                         Acetylprocainami
                         de Control
                         Materials.
862.3280..............  Procainamide       LBA          ................
                         Control
                         Materials.
864.7040..............  ATP Release        JWR          ................
                         (Luminescence).
864.7040..............  Adenine            KHF          ................
                         Nucleotide
                         Quantitation.
866.2900..............  Device, Parasite   LKS          ................
                         Concentration.
872.4565..............  Parallelometer...  EGI          ................
872.4565..............  Syringe,           EIB          ................
                         Irrigating
                         (Dental).
876.5160..............  External Urethral  MNG          ................
                         Occluder,
                         Urinary
                         Incontinence-
                         Control, Female.
878.4014..............  Kit, First Aid,    OVR          ................
                         Talking.
880.5680..............  Pediatric          PRN          ................
                         Position Holder.
880.6250..............  Finger Cot.......  LZB          ................
880.6320..............  Device, Medical    KZF          ................
                         Examination, AC
                         Powered.
880.6320..............  Accessories to     PEQ          ................
                         Examination
                         Light.
880.6375..............  Lubricant,         KMJ          ................
                         Patient.
880.6760..............  Restraint,         BRT          ................
                         Patient,
                         Conductive.
880.6760..............  Restraint,         FMQ          ................
                         Protective.
880.6760..............  Patient Bed with   OYS          ................
                         Canopy/
                         Restraints.
882.1030..............  Ataxiagraph......  GWW          Exemption is
                                                         limited to
                                                         ataxiagraph
                                                         devices not
                                                         intended to
                                                         provide an
                                                         interpretation
                                                         or a clinical
                                                         implication of
                                                         the
                                                         measurement.
882.4060..............  Cannula,           HCD          ................
                         Ventricular.
882.4545..............  Instrument, Shunt  GYK          ................
                         System
                         Implantation.
884.5435..............  Pad, Menstrual,    NUQ          ................
                         Reusable.
884.5435..............  Pad, Interlabial.  NUR          ................

886.4070..............  Engine, Trephine,  HLD          ................
                         Accessories, Gas-
                         powered.
886.4070..............  Burr, Corneal,     HOG          ................
                         Battery-powered.
886.4070..............  Engine, Trephine,  HRF          ................
                         Accessories,
                         Battery-powered.
886.4070..............  Engine, Trephine,  HRG          ................
                         Accessories, AC-
                         powered.
886.4070..............  Burr, Corneal, AC- HQS          ................
                         powered.
------------------------------------------------------------------------

    Dated: April 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-07468 Filed 4-12-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 12 (Thursday, January 17, 2013)]
[Notices]
[Pages 3965-3966]
[FR Doc No: 2013-00704]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Actions on Special Permit Applications

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

ACTION: Notice of Actions on Special Permit Applications.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR part 107,
subpart B), notice is hereby given of the actions on special permits
applications in (December to December 2012). The mode of transportation
involved are identified by a number in the ``Nature of Application''
portion of the table below as follows: 1--Motor vehicle, 2--Rail
freight, 3--Cargo vessel, 4--Cargo aircraft only, 5--Passenger-carrying

aircraft. Application numbers prefixed by the letters EE represent
applications for Emergency Special Permits. It should be noted that
some of the sections cited were those in effect at the time certain
special permits were issued.

    Issued in Washington, DC, on January 10, 2013.
Donald Burger,
Chief, Special Permits and Approvals Branch.

------------------------------------------------------------------------
                                                      Nature of special
    S.P. No.         Applicant      Regulation(s)      permit thereof
------------------------------------------------------------------------
                   MODIFICATION SPECIAL PERMIT GRANTED
------------------------------------------------------------------------
14227-M.........  Aluminum Tank    49 CFR           To modify the
                   Industries,      177.834(h),      special permit to
                   Inc. Winter      178.700.         authorize pumps and
                   Haven, FL.                        hoses attached to
                                                     discharge outlets
                                                     during
                                                     transportation if
                                                     certain
                                                     requirements are
                                                     met.
------------------------------------------------------------------------
                       NEW SPECIAL PERMIT GRANTED
------------------------------------------------------------------------
15671-N.........  Formulated       49 CFR           To authorize
                   Solutions        173.306(a)(3)(   construction of DOT
                   Largo, FL.       v).              2P or DOT 2Q non-
                                                     refillable aerosol
                                                     container using an
                                                     alternative leak
                                                     test in lieu of the
                                                     hot water bath.
                                                     (modes 1, 2, 3, 4)
15690-N.........  Duke Energy      49 CFR 171.8;    To authorize the
                   Corp.            172.300;         transportation in
                   Charlotte, NC.   172.400;         commerce of test
                                    172.500;         kits containing
                                    173.6;           minor amounts of
                                    177.817; Part    alkali metal
                                    178.             dispersed in
                                                     mineral oil. (mode
                                                     1)
------------------------------------------------------------------------
                    EMERGENCY SPECIAL PERMIT GRANTED
------------------------------------------------------------------------
15766-N.........  Gateway          49 CFR 172.301,  To authorizes the
                   Pyrotechnic      172.320 and      one-time, one-way
                   Production,      173.56.          transportation in
                   LLC, dba                          commerce of
                   Gateway                           approximately
                   Fireworks                         46,000 pounds gross
                   Displays St.                      weight of
                   Louis, MO.                        unapproved
                                                     fireworks from
                                                     Dayton, OH to an
                                                     approved storage
                                                     bunker in
                                                     Illiopolis, IL by
                                                     motor vehicle.
                                                     (mode 1)
------------------------------------------------------------------------
                      NEW SPECIAL PERMIT WITHDRAWN
------------------------------------------------------------------------
15675-N.........  The Boeing       49 CFR 172.101   To authorize the one-
                   Company St.      Column (9B).     time transportation
                   Louis, MO.                        in commerce of
                                                     certain explosives
                                                     that are forbidden
                                                     for transportation
                                                     by cargo only
                                                     aircraft. (mode 4)
15684-N.........  Pratt & Whitney  49 CFR           To authorize the
                   Rocketdyne,      173.185(a)(4).   transportation in
                   Inc Canoga                        commerce of power
                   Park, CA.                         systems that
                                                     consist of lithium
                                                     ion battery
                                                     assemblies. (mode
                                                     1)
------------------------------------------------------------------------
                                 DENIED
------------------------------------------------------------------------
14912-M.........  Request by ITW Sexton Decatur, AL December 20, 2012.
                   To authorize the addition of a Division 2.1 material
                   and require burst pressure of containers to not be
                   below 480 psig.
15719-N.........  Request by Ameripak Pontiac, MI December 20, 2012. To
                   authorize the manufacture, mark, sale and use of
                   UN5OD plywood box for the transportation in commerce
                   of lithium batteries.
------------------------------------------------------------------------

[FR Doc. 2013-00704 Filed 1-16-13; 8:45 am]
BILLING CODE 4909-60-M


[Federal Register: October 29, 2008 (Volume 73, Number 210)]
[Notices]
[Page 64314-64316]
[DOCID:fr29oc08-51]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2008-0297; FRL-8736-1]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for Coke Oven Batteries
(Renewal), EPA ICR Number 1362.08, OMB Control Number 2060-0253

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C.

3501 et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before November 28,
2008.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2008-0297, to (1) EPA online using http://www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
1201T, 2200 Pennsylvania Avenue, NW., Washington, DC 20460, and (2) OMB
at: Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street,
NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Mar[iacute]a Malav[eacute], Compliance
Assessment and Media Programs Division, Mail Code 2223A, Office of
Compliance, Environmental ProtectionAgency, 1200 Pennsylvania Avenue,
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On May 30, 2008 (73 FR 31088), EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional
comments on this ICR should be submitted to EPA and OMB within 30 days
of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2008-0297, which is available for public viewing
online at http://www.regulations.gov, in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC),
EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Reading Room is<PHONE_NUMBER>, and the telephone number
for the Enforcement and Compliance Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov, as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://
www.regulations.gov.
    Title: NESHAP for Coke Oven Batteries (Renewal)
    ICR Numbers: EPA ICR Number 1362.08, OMB Control Number 2060-0253
    ICR Status: This ICR is scheduled to expire on December 31, 2008.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
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. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, and displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: The National Emissions Standards Hazardous Air Pollutants
(NESHAP) for Coke Oven Batteries were proposed on December 4, 1992 and
promulgated on October 27, 1993. These standards apply to all coke oven
batteries, whether existing, new, reconstructed, rebuilt or restarted.
It also applies to all batteries using the conventional by-product
recovery, the nonrecovery process, or any new recovery process. Under
this rule, all existing batteries must choose a compliance track. Two
compliance approaches are available under the rule: the ``MACT (Maximum
Achievable Control Technology)'' track, and the ``LAER (Lowest
Achievable Emission Rate)'' extension track, and straddling both tracks
(until January 1, 1998). Applicability dates vary depending on the
emission limitation the affected facility is subject to. This
information is being collected to assure compliance with 40 CFR part
63, subpart L.
    Owners or operators of coke oven batteries, whether existing, new,
reconstructed, rebuilt or restarted, are required to comply with
monitoring, recordkeeping and reporting requirements. Owners or
operators of the affected facilities described must make one-time-only
notifications to select a compliance track and to certify initial
compliance. Owners or operators are also required to maintain records
of the occurrence and duration of any startup, shutdown, or malfunction
in the operation of an affected facility, or any period during which
the monitoring system is inoperative. Monitoring requirements specific
to coke oven batteries provide information on the operation of the
emissions control device and compliance with the visible emissions
standard. Semiannual reports of compliance certifications are required.
These notifications, reports, and records will be used by EPA and the
states to: (1) Identify batteries subject to the standards; (2) ensure
that MACT and LAER are properly applied; and (3) ensure that daily
monitoring and work practice requirements are implemented as required.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 1,908
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information. Respondents/Affected
Entities: Plants with coke oven batteries using the conventional by-
product recovery, the nonrecovery process, or any new recovery process.
    Estimated Number of Respondents: 19
    Frequency of Response: Initially, semiannually, and on occasion.
    Estimated Total Annual Hour Burden: 80,121 hours

    Estimated Annual Costs: $6,564,165 exclusively in Labor cost; there
are neither annualized capital/startup nor O&M costs associated with
this ICR.
    Changes in the Estimates: Although the assumptions in the burden
calculation for this ICR remain the same as in the previous ICR, there
is a small change in the labor hours due to the correction of rounding
errors. The assumptions remain the same as in the previous ICR due to
two considerations: (1) The regulations have not changed over the past
three years and are not anticipated to change over the next three
years; and (2) the growth rate for the industry is very low, negative
or non-existent, so there is no significant change in the overall
burden.

    Dated: October 23, 2008.
Sara Hisel-McCoy,
Director, Collection Strategies Division.
[FR Doc. E8-25803 Filed 10-28-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 239 (Thursday, December 12, 2013)]
[Notices]
[Pages 75644-75645]
[FR Doc No: 2013-29624]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71025; File No. SR-BOX-2013-55]

Self-Regulatory Organizations; BOX Options Exchange LLC; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change to
Amend the Fee Schedule to Permit the Exchange to Exclude from Its
Average Daily Volume Calculations Any Trading Day on Which the Exchange
Is Closed for Trading Due To an Early Closing Or a Market-Wide Trading
Halt

December 6, 2013.
    Pursuant to Section 19(b)(1) under the Securities Exchange Act of
1934 (the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby
given that on November 27, 2013, BOX Options Exchange LLC (the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Exchange filed the proposed rule change pursuant to Section
19(b)(3)(A)(ii) of the Act,\3\ and Rule 19b-4(f)(2) thereunder,\4\
which renders the proposal effective upon filing with the Commission.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

    The Exchange is filing with the Securities and Exchange Commission
(``Commission'') a proposed rule change to amend the Fee Schedule for
trading on the BOX Market LLC (``BOX'') options facility the Fee
Schedule to permit the Exchange to adjust the average daily volume
calculation for any trading day on which the Exchange is closed for
trading due to an early closing or a market-wide trading halt. The text
of the proposed rule change is available from the principal office of
the Exchange, at the Commission's Public Reference Room and also on the
Exchange's Internet Web site at http://boxexchange.com.

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

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

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

 1. Purpose
    The Exchange proposes to amend the Fee Schedule for trading on BOX
to permit the Exchange to adjust the average daily volume (``ADV'')
calculation for any trading day on which the Exchange is closed for
trading due to an early closing or a market-wide trading halt.
    In Section I (Exchange Fees) of the BOX Fee Schedule, the Exchange
provides volume-based incentives for certain transaction fees. In
Section I.A the Exchange provides a volume-based incentive to
Initiating Participants that submit Primary Improvement Orders,
Facilitation Orders, or Solicitation Orders and, on a daily basis,
trade a monthly ADV of more than 5,000 contracts in Auction
Transactions on BOX. Similarly, in Section I.B. the Exchange provides a
volume-based incentive on all standard transaction fees to Market
Makers that, on a daily basis, trade a monthly ADV of more than 5,000
contracts on BOX. In both Sections the Participant's monthly ADV is
calculated at the end of each month.
    The Exchange is proposing to amend the BOX Fee Schedule to permit
the Exchange to adjust the ADV calculation for any trading day where
the market is not open for the entire trading day. Specifically, in
these situations the Exchange could count any day when the market
closes early due to a holiday observance as a half day in the
calculation, or exclude from the calculation any day where the Exchange
declares a trading halt in all securities or honors a market-wide
trading halt declared by another market. For example, this would have
allowed the Exchange to exclude August 22, 2013 when trading was halted
in Nasdaq-listed securities for three hours across all exchanges. The
Exchange is not proposing any changes to the monthly ADV thresholds
required to achieve each volume tier and will issue an information
circular to inform Participants of any trading day where the monthly
ADV calculations will be adjusted in connection with this proposed rule
change.
    The Exchange believes it is appropriate to adjust the calculation
of monthly ADV for these days because a Participant will have
artificially low trading volume if the market is not open for the
entire trading day. In the corresponding monthly ADV calculation, the
numerator for the calculation (trading volume) will decrease, while the
denominator (the number of trading days) will remain the same and not
reflect the irregularity that caused the decrease. This would result in
a lower monthly ADV for the Participant and could mean that the
Participant is not eligible for a higher volume tier, and corresponding
lower fee. Accordingly, giving the Exchange the ability to exclude
these days from the monthly ADV calculation will ensure this scenario
no longer occurs.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act, in general, and Section
6(b)(4) and 6(b)(5) of the Act,\5\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees, and other
charges among BOX Participants and other persons using its facilities
and does not unfairly discriminate between customers, issuers, brokers
or dealers.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange believes that it is equitable and reasonable to adjust
the monthly ADV calculations for any trading day on which the Exchange
is closed for trading due to an early closing or a market-wide trading
halt because it preserves the Exchange's intent behind adopting volume
based fees. The proposed change is non-discriminatory because it
applies equally to all Participants and to all volume tiers.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. With respect to monthly ADV
calculations, the Exchange notes that there are very few instances
where this change will actually be invoked, and when invoked, the
Exchange believes the rule will have little or no impact on trading
decisions or execution quality. To the contrary, the Exchange believes
that the proposed modification to its ADV calculation is pro-
competitive and will result in lower total costs to Participants, a
positive

outcome of competitive markets. Moreover, other options exchanges have
adopted rules that are similar to the change in ADV calculation being
proposed by the Exchange.\6\
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release Nos. 70472 (September
23, 2013), 78 FR 59738 (September 27, 2013)(Notice of Filing and
Immediate Effectiveness of SR-PHLX-2013-93); 70470 (September 23,
2013) 78 FR 59740 (September 27, 2013)(Notice of Filing and
Immediate Effectiveness of SR-NASDAQ-2013-117); and 70657 (October
10, 2013), 78 FR 62899 (October 22, 2013)(Notice of Filing and
Immediate Effectiveness of SR-ISE-2013-51).
---------------------------------------------------------------------------

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Exchange Act \7\ and Rule 19b-4(f)(2)
thereunder,\8\ because it establishes or changes a due or fee.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \8\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend the rule
change if it appears to the Commission that the action is necessary or
appropriate in the public interest, for the protection of investors, or
would otherwise further the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BOX-2013-55 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BOX-2013-55. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 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-BOX-2013-55 and should be
submitted on or before January 2, 2014.
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-29624 Filed 12-11-13; 8:45 am]
BILLING CODE 8011-01-P


(vi) For the purposes of compliance with this section, a license is
valid for the period of time stipulated by the licensing department/
office, but no longer than 5 years.
    (2) Certification. When an operator is not required to be licensed
under paragraph (c)(1), the operator must be certified in accordance
with paragraph (d) or (e) of this section.
    (3) Whenever operator certification/licensure is required under
Sec.  1926.1427, the employer must provide the certification at no cost
to employees.
    (4) A testing entity is permitted to provide training as well as
testing services as long as the criteria of the applicable governmental
or accrediting agency (in the option selected) for an organization
providing both services are met.
    (d) Certification by an accredited crane operator testing
organization. (1) For a certification to satisfy the requirements of
this section, the crane operator testing organization providing the
certification must:
    (i) Be accredited by a nationally recognized accrediting agency
based on that agency's determination that industry-recognized criteria
for written testing materials, practical examinations, test
administration, grading, facilities/equipment, and personnel have been
met.
    (ii) Administer written and practical tests that:
    (A) Assess the operator applicant regarding, at a minimum, the
knowledge and skills listed in paragraphs (j)(1) and (2) of this
section.
    (B) Provide certification based on equipment type, or type and
capacity.
    (iii) Have procedures for operators to re-apply and be re-tested in
the event an operator applicant fails a test or is decertified.
    (iv) Have testing procedures for re-certification designed to
ensure that the operator continues to meet the technical knowledge and
skills requirements in paragraphs (j)(1) and (2) of this section.
    (v) Have its accreditation reviewed by the nationally recognized
accrediting agency at least every 3 years.
    (2) If no accredited testing agency offers certification
examinations for a particular type of equipment, an operator will be
deemed certified for that equipment if the operator has been certified
for the type that is most similar to that equipment and for which a
certification examination is available. The operator's certificate must
state the type of equipment for which the operator is certified.
    (3) A certification issued under this option is portable among
employers who are required to have operators certified under this
option.
    (4) A certification issued under this paragraph is valid for 5
years.
    (e) Audited employer program. The employer's certification of its
employee must meet the following requirements:
    (1) The written and practical tests must be either:
    (i) Developed by an accredited crane operator testing organization
(see paragraph (d) of this section); or
    (ii) Approved by an auditor in accordance with the following
requirements:
    (A) The auditor is certified to evaluate such tests by an
accredited crane operator testing organization (see paragraph (d) of
this section).
    (B) The auditor is not an employee of the employer.
    (C) The approval must be based on the auditor's determination that
the written and practical tests meet nationally recognized test
development criteria and are valid and reliable in assessing the
operator applicants regarding, at a minimum, the knowledge and skills
listed in paragraphs (j)(1) and (2) of this section.
    (D) The audit must be conducted in accordance with nationally
recognized auditing standards.
    (2) Administration of tests. (i) The written and practical tests
must be administered under circumstances approved by the auditor as
meeting nationally recognized test administration standards.
    (ii) The auditor must be certified to evaluate the administration
of the written and practical tests by an accredited crane operator
testing organization (see paragraph (d) of this section).
    (iii) The auditor must not be an employee of the employer.
    (iv) The audit must be conducted in accordance with nationally
recognized auditing standards.
    (3) The employer program must be audited within 3 months of the

beginning of the program and at least every 3 years thereafter.
    (4) The employer program must have testing procedures for re-
qualification designed to ensure that the operator continues to meet
the technical knowledge and skills requirements in paragraphs (j)(1)
and (2) of this section. The re-qualification procedures must be
audited in accordance with paragraphs (e)(1) and (2) of this section.
    (5) Deficiencies. If the auditor determines that there is a
significant deficiency (``deficiency'') in the program, the employer
must ensure that:
    (i) No operator is qualified until the auditor confirms that the
deficiency has been corrected.
    (ii) The program is audited again within 180 days of the
confirmation that the deficiency was corrected.
    (iii) The auditor files a documented report of the deficiency to
the appropriate Regional Office of the Occupational Safety and Health
Administration within 15 days of the auditor's determination that there
is a deficiency.
    (iv) Records of the audits of the employer's program are maintained
by the auditor for 3 years and are made available by the auditor to the
Secretary of Labor or the Secretary's designated representative upon
request.
    (6) A certification under this paragraph is:
    (i) Not portable. Such a certification meets the requirements of
paragraph (c) of this section only where the operator is employed by
(and operating the equipment for) the employer that issued the
qualification.
    (ii) Valid for 5 years.
    (f) Evaluation. (1) Through an evaluation, the employer must ensure
that each operator demonstrates:
    (i) The skills, knowledge, and judgment necessary to operate the
equipment safely, including those specific to the safety devices,
operational aids, software, and the size and configuration of the
equipment. Size and configuration includes, but is not limited to,
lifting capacity, boom length, attachments, luffing jib, and
counterweight set-up.
    (ii) The ability to perform the hoisting activities required for
assigned work, including, if applicable, blind lifts, personnel
hoisting, and multi-crane lifts.
    (2) The evaluation must be conducted by an individual who has the
knowledge, training, and experience necessary to assess equipment
operators.
    (3) Once the evaluation is completed successfully, the employer may
allow the operator to operate other equipment that the employer can
demonstrate does not require substantially different skills, knowledge,
or judgment to operate.
    (4) The employer must document the completion of the evaluation.
This document must provide: the operator's name; the evaluator's name
and signature; the date; and the make, model, and configuration of
equipment used in the evaluation. The employer must make the document
available at the worksite.
    (5) When an employer is required to provide an operator with
retraining under paragraph (b)(6) of this section, the employer must
re-evaluate the operator with respect to the subject of the retraining.
    (g) [Reserved.]
    (h) Language and literacy requirements. (1) Tests under this
section may be administered verbally, with answers given verbally,
where the operator candidate:
    (i) Passes a written demonstration of literacy relevant to the
work.
    (ii) Demonstrates the ability to use the type of written
manufacturer procedures applicable to the class/type of equipment for
which the candidate is seeking certification.
    (2) Tests under this section may be administered in any language
the operator candidate understands, and the operator's certification
documentation must note the language in which the test was given. The
operator is only permitted to operate equipment that is furnished with
materials required by this subpart, such as operations manuals and load
charts, that are written in the language of the certification.
    (i) [Reserved.]
    (j) Certification criteria. Certifications must be based on the
following:
    (1) A determination through a written test that:
    (i) The individual knows the information necessary for safe
operation of the specific type of equipment the individual will
operate, including all of the following:
    (A) The controls and operational/performance characteristics.
    (B) Use of, and the ability to calculate (manually or with a
calculator), load/capacity information on a variety of configurations
of the equipment.
    (C) Procedures for preventing and responding to power line contact.
    (D) Technical knowledge of the subject matter criteria listed in
appendix C of this subpart applicable to the specific type of equipment
the individual will operate. Use of the appendix C criteria meets the
requirements of this provision.
    (E) Technical knowledge applicable to the suitability of the
supporting ground and surface to handle expected loads, site hazards,
and site access.
    (F) This subpart, including applicable incorporated materials.
    (ii) The individual is able to read and locate relevant information
in the equipment manual and other materials containing information
referred to in paragraph (j)(1)(i) of this section.
    (2) A determination through a practical test that the individual
has the skills necessary for safe operation of the equipment, including
the following:
    (i) Ability to recognize, from visual and auditory observation, the
items listed in Sec.  1926.1412(d) (shift inspection).
    (ii) Operational and maneuvering skills.
    (iii) Application of load chart information.
    (iv) Application of safe shut-down and securing procedures.
    (k) Effective date. The certification requirements of this section
are applicable November 10, 2018.
0
3. Amend Sec.  1926.1430 to:
0
a. Revise paragraphs (c)(1) and (c)(2);
0
b. Remove paragraph (c)(3); and
0
c. Redesignate paragraph (c)(4) as (c)(3) to read as follows:

Sec.  1926.1430  Training.

* * * * *
    (c) * * *
    (1) The employer must train each operator in accordance with Sec.
1926.1427(a) and (b), on the safe operation of the equipment the
operator will be using.
    (2) Operators excepted from the requirements of Sec.  1926.1427.
The employer must train each operator covered under the exception of
Sec.  1926.1427(a)(2) on the safe operation of the equipment the
operator will be using.
* * * * *
0
4. Amend Sec.  1926.1436 by revising paragraph (q) to read as follows:

Sec.  1926.1436  Derricks.

* * * * *
    (q) Qualification and Training. The employer must train each
operator of a derrick on the safe operation of equipment the individual
will operate. Section 1926.1427 of this subpart (Operator training,
certification, and evaluation) does not apply, except for the
evaluation requirements of Sec.  1926.1427(f).
0
5. Amend Sec.  1926.1440 by revising paragraph (a) to read as follows:

Sec.  1926.1440  Sideboom cranes.

    (a) The provisions of this subpart apply, except Sec.  1926.1420
(Ground conditions), Sec.  1926.1415 (Safety

devices), Sec.  1926.1416 (Operational aids), and Sec.  1926.1427
(Operator training, certification, and evaluation) paragraphs (a)-(e)
and (g)-(k). Section 1926.1427(f) (Evaluation) applies.
* * * * *
0
6. Amend Sec.  1926.1441 by revising paragraph (a) to read as follows:

Sec.  1926.1441  Equipment with a rated hoisting/lifting capacity of
2,000 pounds or less.

* * * * *
    (a) The employer using this equipment must comply with the
following provisions of this subpart: Sec.  1926.1400 (Scope); Sec.
1926.1401 (Definitions); Sec.  1926.1402 (Ground conditions); Sec.
1926.1403 (Assembly/disassembly--selection of manufacturer or employer
procedures); Sec.  1926.1406 (Assembly/disassembly--employer
procedures); Sec. Sec.  1926.1407 through 1926.1411 (Power line
safety); Sec.  1926.1412(c) (Post-assembly); Sec. Sec.  1926.1413
through 1926.1414 (Wire rope); Sec.  1926.1418 (Authority to stop
operation); Sec. Sec.  1926.1419 through 1926.1422 (Signals); Sec.
1926.1423 (Fall protection); Sec.  1926.1425 (Keeping clear of the
load) (except for Sec.  1926.1425(c)(3) (qualified rigger)); Sec.
1926.1426 (Free fall and controlled load lowering); Sec.  1926.1427(f)
(Evaluation); Sec.  1926.1432 (Multiple crane/derrick lifts--
supplemental requirements); Sec.  1926.1434 (Equipment modifications);
Sec.  1926.1435 (Tower cranes); Sec.  1926.1436 (Derricks); Sec.
1926.1437 (Floating cranes/derricks and land cranes/derricks on
barges); Sec.  1926.1438 (Overhead & gantry cranes).
* * * * *
[FR Doc. 2018-10559 Filed 5-18-18; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 77, Number 241 (Friday, December 14, 2012)]
[Notices]
[Pages 74485-74486]
[FR Doc No: 2012-30123]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0711]

Request for Comments and Information on Initiating a Risk
Assessment for Establishing Food Allergen Thresholds; Establishment of
Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is establishing a
docket to obtain comments relevant to conducting a risk assessment to
establish regulatory thresholds for major food allergens as defined in
the Food Allergen Labeling and Consumer Protection Act of 2004.

DATES: Submit either electronic or written comments by February 12,
2013.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-0711, 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:
     Fax:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper or CD-ROM
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 Agency name
and Docket No. FDA-2012-N-0711. 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:  Steven M. Gendel, Center for Food
Safety and Applied Nutrition (HFS-200), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Food allergy is an immune-mediated sensitivity to foods that can
lead to life-threatening adverse reactions. Because there is no cure
for food allergy, allergic consumers must use avoidance to prevent
allergic reactions. Successful avoidance requires, among other things,
that allergic consumers and their caregivers be able to read and
understand the ingredient lists on packaged foods.
    To help consumers more easily identify ingredients in foods that
may cause an allergic reaction, the President signed the Food Allergen
Labeling and Consumer Protection Act of 2004 (FALCPA) (Title II of Pub.
L. 108-282), which amended the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) by defining the term ``major food allergen'' and stating
that foods regulated under the FD&C Act are misbranded unless they
declare the presence of major food allergens on the product label using
the common or usual name of that major food allergen. Section 201(qq)
of the FD&C Act (21 U.S.C. 321(qq)) now defines a major food allergen
as ``[m]ilk, egg, fish (e.g., bass, flounder, or cod), Crustacean
shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds,
pecans, or walnuts), wheat, peanuts, and soybeans'' and also as a food
ingredient that contains protein derived from such foods. The
definition excludes any highly refined oil derived from a major food
allergen and any ingredient derived from such highly refined oil.
    FALCPA provides two mechanisms through which ingredients may become
exempt from the major food allergen labeling requirement. An individual
may petition for an exemption by providing scientific evidence,
including the analytical method used, that an ingredient ``does not
cause an allergic response that poses a risk to human health.'' (21
U.S.C. 403(w)(6)(C)). Alternatively, an individual may submit a
notification that contains either scientific evidence showing that an
ingredient ``does not contain allergenic protein'' or that a
determination has previously been made through a premarket approval
process that the ingredient ``does not cause an allergic response that
poses a risk to human health.'' (21 U.S.C. 403(w)(7)(A)).
    In addition to their intended use as ingredients, the unintended
presence of major food allergens in foods may occur through cross-
contact. Cross-contact describes the inadvertent introduction of an
allergen into a product that would not intentionally contain that
allergen as an ingredient. Most cross-contact can be avoided by
controlling the production environment. These controls can include a
wide range of activities, such as establishing personnel and traffic
patterns that minimize the potential to transfer an allergen from one
product to another.
    FDA has used several risk management strategies to reduce the risk
from unlabeled major food allergens, such as targeted inspections or
discussions with industry organizations. However, we have not
established regulatory thresholds or action levels for major food
allergens. The establishment of regulatory thresholds or action levels
for major food allergens would help us

determine whether, or what type of, enforcement action is appropriate
when specific problems are identified and also help us establish a
clear standard for evaluating claims in FALCPA petitions that an
ingredient ``does not cause an allergic response that poses a risk to
human health'' or ``does not contain allergenic protein.'' Regulatory
thresholds also would help industry to conduct allergen hazard analyses
and develop standards for evaluating the effectiveness of allergen
preventive controls.

II. Food Safety Risk Assessment for Establishing Food Allergen
Thresholds

    The FDA Threshold Working Group (the working group) has previously
evaluated the approaches that could be used for establishing thresholds
for food allergens (Ref. 1). Of the four approaches that were
identified (methods-based, safety assessment-based, risk assessment-
based, and statutorily-derived), the working group identified the
quantitative risk assessment-based approach as being the ``strongest,
most transparent'' approach. Further, the working group determined that
this approach provides the most insight into both the level of
protection and the degree of uncertainty associated with an exposure
level. The working group also acknowledged the need for clinical and
epidemiological data to support a quantitative risk assessment and to
develop applicable risk assessment tools.
    Since the working group's report was published in March 2006, there
have been significant advances in both scientific tools and data
resources related to food allergens. Therefore, we intend to determine
if the currently available data and analysis tools are sufficient to
support a quantitative risk assessment and, if so, to use these data
and tools to evaluate the public health impact of establishing specific
regulatory thresholds for one or more of the major food allergens.

III. Establishment of a Docket and Request for Information

    We are establishing a docket to provide an opportunity for
interested individuals to submit comments (including data) that we can
use to design and carry out a quantitative risk assessment for
establishing regulatory thresholds for major food allergens. In
particular, we invite comments on the following matters:
    1. How should we define ``an allergic response that poses a risk to
human health?''
    2. Which major food allergens are of greatest public health concern
and what is the size of the at-risk population?
    3. How should clinical dose distribution data be used when
establishing regulatory thresholds for the major food allergens?
    4. What approaches exist for using biological markers or other
factors related to the severity of allergic responses in a threshold
risk assessment?
    5. What data and information exist on dietary exposure patterns for
individuals on allergen avoidance diets?
    6. What data or other information exist on current levels of
exposure associated with the consumption of undeclared major food
allergens in packaged foods?
    7. What other information or data should we consider in
establishing regulatory thresholds for major food allergens?

IV. Comments

    Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. 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.

V. Reference

    FDA has placed the following reference on display. To view the
reference, 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. The reference may also be seen in the Division of
Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.
    1. Threshold Working Group, 2006, Approaches to Establish
Thresholds for Major Food Allergen and for Gluten in Food, available at
http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm106108.htm, accessed
December 5, 2012. (FDA has verified this Web site address, but FDA is
not responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register).

    Dated: December 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30123 Filed 12-13-12; 8:45 am]
BILLING CODE 4160-01-P