[Federal Register: September 3, 2009 (Volume 74, Number 170)]
[Proposed Rules]
[Page 45576-45578]
[DOCID:fr03se09-15]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Part 284

[128 FERC ] 61,187; Docket No. RM09-2-000]

Contract Reporting Requirements of Intrastate Natural Gas
Companies; Notice Requesting Comments on Proposed Standardized
Electronic Information Collection and Extending Time for Comments on
Notice of Proposed Rulemaking

August 26, 2009.
AGENCY: Federal Energy Regulatory Commission, Energy.

ACTION: Notice of proposed standardized electronic information
collection and request for comments.

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SUMMARY: In compliance with the requirements of Section 3506(c)(2)(A)
of the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A) (2006),
the Federal Energy Regulatory Commission (FERC or Commission) is
soliciting public comment on the proposed standardized electronic
information collection to be used by Natural Gas Policy Act (NGPA)
section 311 and Hinshaw pipelines for submitting the quarterly
transactional reports proposed in the Notice of Proposed Rulemaking,
issued on July 16, 2009 and published on July 29, 2009 (74 FR 37658) in
this docket. This notice also extends the deadline for comments on the
Notice of Proposed Rulemaking, so that all comments will be due on the
same date.

DATES: Comments on the proposed standardized electronic information
collection are due November 2, 2009.
    Comments on the Notice of Proposed Rulemaking published on July 29,
2009 (74 FR 37658) are now also due November 2, 2009.

ADDRESSES: Comments may be filed either electronically (eFiled) or in
paper format, and should refer to Docket No. RM09-2-000. Documents must
be prepared in an acceptable filing format and in compliance with
Commission submission guidelines at http://www.ferc.gov/help/
submission-guide.asp.
    Comments may be eFiled. The eFiling option under the Documents &
Filings tab on the Commission's Web page (http://www.ferc.gov) directs
users to the eFiling Web page. First-time users should follow the
eRegister instructions on the eFiling tab on the Web page to establish
a user name and password before eFiling. Filers will receive an e-
mailed confirmation of their eFiled comments.
    Commenters filing electronically should not make a paper filing.
Commenters that are not able to file electronically must send an
original and 14 paper copies of the filing to: Federal Energy
Regulatory Commission, Secretary of the Commission, 888 First Street,
NE., Washington, DC 20426.
    Parties interested in receiving automatic notification of activity
in this docket may do so through eSubscription. The eSubscription
option under the Documents & Filings tab on the Commission's Web page
directs users to the eSubscription Web page. Users submit the docket
numbers of the filings they wish to track and will subsequently receive
an e-mail notification each time a filing is made under the submitted
docket numbers. First-time users will need to establish a user name and
password before eSubscribing.
    Filed comments and FERC issuances may be viewed, printed, and
downloaded remotely from the Commission's Web site. The eLibrary link
found at the top of most of the Commission's Web pages directs users to
FERC's eLibrary. From the eLibrary tab on the Web page, choose General
Search, and in the Docket Number space provided, enter RM09-2, then
click the Submit button at the bottom of the page. For help with any of
the Commission's electronic submission or retrieval systems, contact
FERC Online Support via e-mail at<EMAIL_ADDRESS>or
telephone toll-free:<PHONE_NUMBER> (TTY<PHONE_NUMBER>).

FOR FURTHER INFORMATION CONTACT: Michael Miller may be reached by
telephone at<PHONE_NUMBER>, by fax at<PHONE_NUMBER>, and by e-mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    1. On July 16, 2009, the Commission issued a Notice of Proposed
Rulemaking (NOPR) \1\ in this docket proposing to revise the contract
reporting requirements for (1) intrastate pipelines providing
interstate services pursuant to section 311 of the NGPA; \2\ and (2)
Hinshaw pipelines providing interstate services subject to the
Commission's NGA section 1(c) jurisdiction pursuant to blanket
certificates issued under Sec.  284.224 of the Commission's
regulations. Specifically, the NOPR proposed to amend Sec.  284.126(b)
of the Commission's regulations to require that NGPA section 311 and
Hinshaw pipelines make quarterly reports that contain, for each
transportation and storage service provided during the preceding
calendar quarter, the following information:
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    \1\ Contract Reporting Requirements of Intrastate Natural Gas
Companies, FERC Stats. & Regs. ] 32,644 (2009) (NOPR) published in
the Federal Register on July 29, 2009 (74 FR 37658).
    \2\ 15 U.S.C. 3372.
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    i. The full legal name, and identification number, of the shipper
receiving the service, including whether there is an affiliate
relationship between the pipeline and the shipper;
    ii. The type of service performed (i.e., firm or interruptible
transportation, storage, or other service);
    iii. The rate charged under each contract, specifying the rate
schedule/name of service and docket where the rates were approved. The
report should separately state each rate component set forth in the
contract (i.e. reservation, usage, and any other charges);
    iv. The primary receipt and delivery points covered by the
contract, including the industry common code for each point;
    v. The quantity of natural gas the shipper is entitled to
transport, store, or deliver under each contract;
    vi. The duration of the contract, specifying the beginning and
ending month and year of the current agreement;
    vii. Total volumes transported, stored, injected, or withdrawn for
the shipper; and
    viii. Total revenues received from the shipper. The report should
separately state revenues received under each rate component.
    2. In order to make the proposed quarterly reports more accessible
to the public, the NOPR also proposed requiring that the reports be
filed in a standardized electronic format to be developed by the
Commission staff. In the NOPR, the Commission stated that it was ``in
the process of developing a standardized electronic format for making
the reports proposed in this NOPR. Once that process is complete, the
Commission will make the standardized format available for public
comment.'' \3\
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    \3\ NOPR, FERC Stats. & Regs. ] 32,644 at P 29.
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    3. By this notice, the Commission is requesting comment on the
proposed quarterly reports. Attached to this Notice as an Appendix are:
    i. A table that shows all the data elements (fields) that would be
collected each quarter for each shipper that a filing entity provides
with transportation or storage service. The table is not an example of
the collection instrument or how the Commission intends to collect the
information.
    ii. A Data Dictionary and associated units of measure that defines
what each element means and its characteristics (e.g. text field with
10 characters, e-mail address, numerical field, and relationship to
other elements).
    iii. Instructions to assist filers to report the data each quarter.
    4. The Commission seeks comment on its proposal to adopt for
reporting purposes an XML Schema.\4\ Under the XML approach, filing
entities submitting their quarterly data would be required to submit an
XML filing package \5\ that conforms to the XML Schema developed and
maintained by FERC. Filers would be allowed to submit their XML filing
packages using the existing eFiling portal. Once submitted, the XML
filing package would undergo quality checks to see if it conforms to
the XML Schema. Filing entities would receive an e-mail confirmation if
the filing is successful or needs to be corrected. This approach is
similar to that being developed for electronic tariffs in Docket No.
RM01-

5-000. See http://www.ferc.gov/docs-filing/etariff.asp.\6\
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    \4\ The XML schema is a method by which the filing entities can
communicate information to the Commission. The schema proscribes the
metadata elements and the textual information that must be included
in the filing package. The data elements included in the XML filing
package are required to properly identify the nature of the FERC-
549D, organize the FERC-549D database, and maintain the proper
relationship of elements in relation to other elements.
    \5\ Filing entities would develop the XML filing package in
accordance with the Commission's XML Schema. Open source and fee-
based software is available to convert data in a spreadsheet and
other documents into the XML filing package. The latest versions of
Text Editors and Word Processing application may also have the
capability to create the XML filing package.
    \6\ See also Common FAQs about XML at http://xml.silmaril.ie/.
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    5. In addition, the Commission seeks comment on whether an ASP.NET
Web-based form is more appropriate. Under the ASP.NET approach, the
Commission would create a Web-based form that would be accessible to
filers on the FERC Web site. Filing entities would not use the eFiling
portal to submit their data. The Web-based form would be formatted and
contain blank fields that filing entities can fill in with data for
each shipper it provides with transportation or storage service each
quarter. Once submitted, the data would undergo quality checks. Filing
entities would receive an e-mail confirmation if the submission is
successful or needs to be corrected.
    Comments are also invited on the following issues:
    1. Problems in measuring data elements collected in the table and
data dictionary;
    2. Terms and definitions of the elements in the table, data
dictionary and instructions;
    3. Whether the units of measure are appropriate;
    4. Whether the instructions are clear or require modification;
    5. The accuracy of the agency's burden estimate of the proposed
collection of information;
    6. Ways to enhance the quality, utility and clarity of the
information to be collected;
    7. Ways to minimize respondent information collection burden; and
    8. The most effective way for the Commission to present the
collected information to the public on the FERC Web site.
    6. A paper version of the table with proposed data elements,
instructions, and data dictionary, are attached as the Appendix to this
Notice, but they are not being printed in the Federal Register. The
Appendix is available on the FERC's eLibrary (http://www.ferc.gov/docs-
filing/elibrary.asp) by searching Docket No. RM09-2, and through the
FERC Public Reference Room. Interested parties may also request paper
copies of the table, instructions, and data dictionary by contacting
Michael Miller by telephone at<PHONE_NUMBER>, by fax at (202) 273-
0873, or by e-mail at<EMAIL_ADDRESS>    7. Comments on the proposed standardized electronic information
collection and related burden estimate, including any related matters
or alternative proposals that commenters may wish to discuss, must be
submitted by 60 days after publication of this Notice in the Federal
Register. The Commission shall also delay the date on which comments on
the NOPR are due to the same date, in order to permit parties to
include comments on the standardized electronic information collection
within their comments on the NOPR.
    Burden Statement: The proposed survey targets respondents who
directly serve wholesale and retail customers. The Commission estimated
in the NOPR that on an annual basis the burden to comply with this
proposed rule will be as follows:

----------------------------------------------------------------------------------------------------------------
                                                 Number of        Number of     Average  burden
                                                respondents     responses  per     hours  per      Total annual
                                                  annually        respondent        response       burden hours
                                                         (1)              (2)              (3)   (1) x (2) x (3)
----------------------------------------------------------------------------------------------------------------
FERC-549D...................................             125                4              3.5            1,750
----------------------------------------------------------------------------------------------------------------

    Because of the various staffing levels that will be involved in
preparing the documentation (legal, technical and support) the
Commission is using an hourly rate of $150 to estimate the costs for
filing and other administrative processes (reviewing instructions,
searching data sources, completing and transmitting the collection of
information). The estimated total annual cost to respondents is
anticipated to be $262,500 [1,750 Total Annual Burden Hours times $150
per hour equals $262,500]. The cost per respondent is $2,100.
    8. The reporting burden includes the total time, effort, or
financial resources expended to generate, maintain, retain, disclose,
or provide the information including: (1) Reviewing instructions; (2)
developing, acquiring, installing, and utilizing technology and systems
for the purposes of collecting, validating, verifying, processing,
maintaining, disclosing and providing information; (3) adjusting the
existing ways to comply with any previously applicable instructions and
requirements; (4) training personnel to respond to a collection of
information; (5) searching data sources; (6) completing and reviewing
the collection of information; and (7) transmitting, or otherwise
disclosing the information.
    9. The respondent's cost estimate is based on salaries for
professional and clerical support, as well as direct and indirect
overhead costs. Direct costs include all costs directly attributable to
providing this information, such as administrative costs and the cost
for information technology. Indirect or overhead costs are costs
incurred by an organization in support of its mission. These costs
apply to activities which benefit the whole organization rather than
any one particular function or activity.

    By direction of the Commission.
Kimberly D. Bose,
Secretary.

    Note: The Appendix (table with proposed FERC-549D data elements,
instructions, and data dictionary) will not be printed in the
Federal Register. The Appendix is available on the FERC's eLibrary
(http://www.ferc.gov/docs-filing/elibrary.asp) by searching Docket
No. RM09-2-000, and through the FERC Public Reference Room.

[FR Doc. E9-21108 Filed 9-2-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 231 (Thursday, December 1, 2011)]
[Notices]
[Pages 74846-74847]
[FR Doc No: 2011-30913]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket Number NHTSA-2011-0165]

Reports, Forms, and Recordkeeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Request for public comment on extension of a currently approved
collection of information.

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SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatement of previously approved collections. This
document describes an existing collection of information for motor
vehicle tire and rim labeling requirements for which NHTSA intends to
seek renewed OMB approval.

DATES: Comments must be received on or before January 30, 2012.

ADDRESSES: Comments must refer to the docket number cited at the
beginning of this notice, and may be submitted by any of the following
methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m.
Eastern Time, Monday through Friday, except Federal Holidays.
Telephone: 1-(800) 647-2251.
    Instructions: All submissions must include the docket number for
this document. Please identify the collection of information for which
a comment is provided by referencing the OMB Control Number, 2127-0503.
Note that all comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://DocketsInfo.dot.gov.

FOR FURTHER INFORMATION CONTACT: Mr. Jeffrey Woods, NHTSA, 1200 New
Jersey Avenue SE., Room W43-467, NVS-122, Washington, DC 20590. Mr.
Woods' telephone number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must first publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulation (at 5 CFR
1320.8(d)), an agency must ask for public comment on the following:
    (1) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (2) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (3) How to enhance the quality, utility and clarity of the
information to be collected;
    (4) How to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology (e.g., permitting electronic
submission of responses).
    In compliance with these requirements, NHTSA asks for public
comments on the following collection of information:
    Title: Tires and Rims Labeling.
    OMB Control Number: 2127-0503.
    Type of Request: Extension of a currently approved collection of
information.
    Form Number: This collection of information uses no standard form.
    Abstract: Each tire manufacturer and rim manufacturer must label
their tires and rims with applicable safety information. In addition,
each vehicle manufacturer must affix a label to each vehicle indicating
the designated tire size for the vehicle. These labeling requirements
ensure that tires are mounted on the appropriate rims, and that the
rims and tires are mounted on the vehicle for which they are intended.
    Affected Public: Business or other for profit.
    Estimated Annual Burden: 274,491 hours.
    Estimated Number of Respondents: 1,780.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility, the accuracy of the Department's estimate of the burden of the
proposed information collection,

ways to enhance the quality, utility and clarity of the information to
be collected and ways to minimize the burden of the collection of
information on respondents, including the use of automated collection
techniques or other forms of information technology.

    Issued on: November 23, 2011.
Christopher J. Bonanti,
Associate Administrator for Rulemaking.
[FR Doc. 2011-30913 Filed 11-30-11; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 79, Number 95 (Friday, May 16, 2014)]
[Rules and Regulations]
[Pages 28404-28407]
[FR Doc No: 2014-11174]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. FDA-2014-N-0438]

Medical Devices; General Hospital and Personal Use Devices;
Classification of the Intravascular Administration Set, Automated Air
Removal System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the
intravascular administration set, automated air removal system into
class II (special controls). The special controls that will apply to
the device are identified in this order and will be part of the
codified language for the intravascular administration set, automated
air removal system's classification. The Agency is classifying the
device into class II (special controls) in order to provide a
reasonable assurance of safety and effectiveness of the device.

DATES: This order is effective June 16, 2014. The classification was
effective on March 4, 2014.

FOR FURTHER INFORMATION CONTACT: Alan Stevens, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave. Bldg. 66, Rm. 2561, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i), to a predicate device that does not
require premarket approval. The Agency determines whether new devices
are substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21

U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144, July 9, 2012), provides two procedures by which a person may
request FDA to classify a device under the criteria set forth in
section 513(a)(1). Under the first procedure, the person submits a
premarket notification under section 510(k) for a device that has not
previously been classified and, within 30 days of receiving an order
classifying the device into class III under section 513(f)(1), the
person requests a classification under section 513(f)(2). Under the
second procedure, rather than first submitting a premarket notification
under section 510(k) and then a request for classification under the
first procedure, the person determines that there is no legally
marketed device upon which to base a determination of substantial
equivalence and requests a classification under section 513(f)(2). If
the person submits a request to classify the device under this second
procedure, FDA may decline to undertake the classification request if
FDA identifies a legally marketed device that could provide a
reasonable basis for review of substantial equivalence with the device
or if FDA determines that the device submitted is not of ``low-moderate
risk'' or that general controls would be inadequate to control the
risks and special controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an
order on October 23, 2008, classifying the AirPurge System into class
III, because it was not substantially equivalent to a device that was
introduced or delivered for introduction into interstate commerce for
commercial distribution before May 28, 1976, or a device which was
subsequently reclassified into class I or class II. On October 29,
2008, Anesthesia Safety Products, LLC submitted a request requesting
classification of the AirPurge System under section 513(f)(2) of the
FD&C Act. The manufacturer recommended that the device be classified
into class II (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act. FDA
classifies devices into class II 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 reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the request, FDA determined that the device
can be classified into class II with the establishment of special
controls. FDA believes these special controls, in addition to general
controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on March 4, 2014, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 880.5445.
    Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for an
intravascular administration set, automated air removal system will
need to comply with the special controls named in this final order. The
device is assigned the generic name intravascular administration set,
automated air removal system, and it is identified as a prescription
device used to detect and automatically remove air from an
intravascular administration set with minimal to no interruption in the
flow of the intravascular fluid. The device may include an air
identification mechanism, software, an air removal mechanism, tubing,
apparatus to collect removed air, and safety control mechanisms to
address hazardous situations.
    FDA has identified the following risks to health associated
specifically with this type of device, as well as the mitigation
measures required to mitigate these risks.

                                Table 1--Identified Risks and Mitigation Measures
----------------------------------------------------------------------------------------------------------------
         Identified risk                                        Mitigation measures
----------------------------------------------------------------------------------------------------------------
Embolus.........................  Hazard Argument.
                                  Software.
                                  Electromagnetic Compatibility.
                                  Human Factors.
                                  Labeling.
                                  Nonclinical Performance Testing.
Infusion Delivery Error.........  Hazard Argument.
                                  Software.
                                  Electromagnetic Compatibility.
                                  Human Factors.
                                  Labeling.
                                  Nonclinical Performance Testing.
Electric Shock..................  Hazard Argument.
                                  Electrical Safety.
                                  Electromagnetic Compatibility.
Adverse Tissue Reaction.........  Hazard Argument.
                                  Biocompatibility.
Infection.......................  Sterilization.
                                  Shelf Life.
----------------------------------------------------------------------------------------------------------------

    FDA believes that the following special controls, in combination
with the general controls, address these risks to health and provide
reasonable assurance of the safety and effectiveness:
    1. Provide an argument demonstrating that all reasonably
foreseeable hazards have been adequately addressed with respect to the
persons for whose use the device is represented or intended and

the conditions of use for the device, which includes the following:
     Description of the device indications for use, design, and
technology, use environments, and users in sufficient detail to
determine that the device complies with all special controls.
     Demonstrate that controls are implemented to address
device system hazards and their causes.
     Include a justification supporting the acceptability
criteria for each hazard control.
     A traceability analysis demonstrating that all credible
hazards have at least one corresponding control and that all controls
have been verified and validated in the final device design.
    2. Appropriate software verification, validation, and hazard
analysis must be performed.
    3. The device parts that directly or indirectly contact the patient
must be demonstrated to be biocompatible.
    4. Performance data must demonstrate the sterility of fluid path
contacting components and the shelf life of these components.
    5. The device must be designed and tested for electrical safety and
electromagnetic compatibility (EMC).
    6. Nonclinical performance testing data must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be tested:
     Device system and component reliability testing must be
conducted.
     Fluid ingress protection testing must be conducted.
     Testing of safety controls must be performed to
demonstrate adequate mitigation of hazardous situations, including
sensor failure, flow control failure, improper device position, device
malfunction, infusion delivery error, and release of air to the
patient.
    7. A human factors validation study must demonstrate that use
hazards are adequately addressed.
    8. The labeling must include the following:
     The device's air identification and removal response time.
     The device's minimum air volume identification
sensitivity.
     The minimum and maximum flow rates at which the device is
capable of reliably detecting and removing air.
     Quantification of any fluid loss during device air removal
operations as a function of flow rate.
    Intravascular administration set, automated air removal systems are
prescription devices restricted to patient use only upon the
authorization of a practitioner licensed by law to administer or use
the device (21 CFR 880.5445(a); see section 520(e) of the FD&C Act (21
U.S.C. 360j(e)) and 21 CFR 801.109 (Prescription devices.)).
Prescription-use restrictions are a type of general controls as defined
in section 513(a)(1)(A)(i) of the FD&C Act.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act, if FDA determines that premarket notification
is not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification, prior to marketing the device,
which contains information about the intravascular administration set,
automated air removal system they intend to market.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
part 807, subpart E, regarding premarket notification submissions have
been approved under OMB control number 0910-0120, and the collections
of information in 21 CFR part 801, regarding labeling have been
approved under OMB control number 0910-0485.

IV. Reference

    The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and is available electronically at http://www.regulations.gov.

1. K080644: De Novo Request per 513(f)(2) pursuant to the Agency's
not substantially equivalent (NSE) determination, dated October 23,
2008, from Anesthesia Safety Products, LLC, dated October 29, 2008.

List of Subjects in 21 CFR Part 880

    Medical devices.

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

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

0
1. The authority citation for 21 CFR part 880 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add Sec.  880.5445 to subpart F to read as follows:

Sec.  880.5445  Intravascular Administration Set, Automated Air Removal
System.

    (a) Identification. An intravascular administration set, automated
air removal system, is a prescription device used to detect and
automatically remove air from an intravascular administration set with
minimal to no interruption in the flow of the intravascular fluid. The
device may include an air identification mechanism, software, an air
removal mechanism, tubing, apparatus to collect removed air, and safety
control mechanisms to address hazardous situations.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Provide an argument demonstrating that all reasonably
foreseeable hazards have been adequately addressed with respect to the
persons for whose use the device is represented or intended and the
conditions of use for the device, which includes the following:
    (i) Description of the device indications for use, design, and
technology, use environments, and users in sufficient detail to
determine that the device complies with all special controls.
    (ii) Demonstrate that controls are implemented to address device
system hazards and their causes.
    (iii) Include a justification supporting the acceptability criteria
for each hazard control.
    (iv) A traceability analysis demonstrating that all credible
hazards have at least one corresponding control and that all controls
have been verified and validated in the final device design.

    (2) Appropriate software verification, validation, and hazard
analysis must be performed.
    (3) The device parts that directly or indirectly contact the
patient must be demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of fluid path
contacting components and the shelf life of these components.
    (5) The device must be designed and tested for electrical safety
and electromagnetic compatibility (EMC).
    (6) Nonclinical performance testing data must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be tested:
    (i) Device system and component reliability testing must be
conducted.
    (ii) Fluid ingress protection testing must be conducted.
    (iii) Testing of safety controls must be performed to demonstrate
adequate mitigation of hazardous situations, including sensor failure,
flow control failure, improper device position, device malfunction,
infusion delivery error, and release of air to the patient.
    (7) A human factors validation study must demonstrate that use
hazards are adequately addressed.
    (8) The labeling must include the following:
    (i) The device's air identification and removal response time.
    (ii) The device's minimum air volume identification sensitivity.
    (iii) The minimum and maximum flow rates at which the device is
capable of reliably detecting and removing air.
    (iv) Quantification of any fluid loss during device air removal
operations as a function of flow rate.

    Dated: May 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11174 Filed 5-15-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 188 (Friday, September 27, 2013)]
[Notices]
[Pages 59670-59671]
[FR Doc No: 2013-23676]

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

[EPA-HQ-OPPT-2012-0674; FRL-9533-2]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Notification of Substantial Risk of Injury
to Health and the Environment Under TSCA Section 8(e)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``Notification of Substantial
Risk of Injury to Health and the Environment under TSCA Section 8(e)''
(EPA ICR No. 0794.13, OMB Control No. 2070-0046) to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a renewal
of the ICR that is currently approved through June 30, 2013. Public
comments were previously requested via the Federal Register (77 FR
71415) on November 30, 2012, during a 60-day comment period. The ICR,
which is abstracted below, describes the nature of the information
collection activity and its expected burden and costs. Copies of the
ICR and related documents are available in the docket.

DATES: Additional comments may be submitted on or before October 28,
2013.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OPPT-2012-0674, to (1) EPA online using http://www.regulations.gov (our
preferred method), by email to<EMAIL_ADDRESS>or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Pamela Myrick, Deputy Director,
Environmental Assistance Division, Office of Pollution Prevention and
Toxics, Mail code: 7408-M, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-554-
1404; fax number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Supporting documents which explain in detail the information that
the EPA will be collecting are available in the public docket for this
ICR. The docket can be viewed online at http://www.regulations.gov or
in person at the EPA Docket Center, EPA West, Room 3334, 1301
Constitution Ave. NW., Washington, DC. The telephone number for the
Docket Center is<PHONE_NUMBER>. For additional information about EPA's
public docket, visit http://www.epa.gov/dockets.
    Abstract: Section 8(e) of the Toxic Substances Control Act (TSCA)
requires that any person who manufactures, imports, processes or
distributes in commerce a chemical substance or mixture and which
obtains information that reasonably supports the conclusion that such
substance or mixture presents a substantial risk of injury to health or
the environment must immediately inform EPA of such information. EPA
routinely disseminates TSCA section 8(e) data it receives to other
Federal agencies to provide information about newly discovered chemical
hazards and risks. This information collection addresses the burden
associated with industry reporting of such notifications. The
respondent may claim all or part of a notice confidential. EPA will
disclose information that is covered by a claim of confidentiality only
to the extent permitted by, and in accordance with, the procedures in
TSCA and 40 CFR Part 2.
    Form Numbers: None.
    Respondents/affected entities: Entities potentially affected by
this action are companies that manufacture, process, import or
distribute in commerce a chemical substance or mixture and that obtain
information that reasonably supports the conclusion that such substance
or mixture presents a substantial risk of injury to health or the
environment.
    Respondent's obligation to respond: mandatory; see 15 USC 2607(e).
    Estimated number of respondents: 555 (total).
    Frequency of response: On occasion.
    Total estimated burden: 19,659 hours per year. Burden is defined at
5 CFR 1320.03(b).
    Total estimated burden cost: $1,366,491 per year, includes $0
annualized capital or operation and maintenance costs.
    Changes in the Estimates: There is a decrease of 10,856 hours in
the total

estimated respondent burden compared with the ICR currently approved by
OMB. This decrease represents changes in the number of estimated
submissions based on EPA's recent experience with TSCA section 8(e)
notices plus the effects of optional electronic reporting. This change
involves both a program change (electronic reporting) and an
adjustment. The Supporting Statement provides additional detail
concerning the change in burden estimate.

    Dated: September 19, 2013.
Richard T. Westlund,
Acting Director, Collection Strategies Division.
[FR Doc. 2013-23676 Filed 9-26-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: May 25, 2006 (Volume 71, Number 101)]
[Notices]
[Page 30207-30209]
[DOCID:fr25my06-116]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53833; File No. SR-NASDAQ-2006-010]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Order Granting Accelerated Approval to a Proposed
Rule Change To Establish Certain Fees With Respect to Transactions
Executed Through the Intermarket Trading System

May 18, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 15, 2006, The NASDAQ Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'' or ``SEC'') the proposed rule change as described in
Items I and II below, which Items have been prepared by Nasdaq. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons, and is approving the
proposal on an accelerated basis.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to enter into arrangements with other
national securities exchanges to pass certain fees they have collected
from members for transactions executed on another exchange through the
Intermarket Trading System (``ITS''). This proposal does not require
changes to Nasdaq rule text. Nasdaq will implement the proposed rule
change immediately upon approval by the Commission.

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 III 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, the Proposed Rule Change

1. Purpose
    Section 31 of the Act \3\ requires each national securities
exchange to pay the Commission a fee based on the aggregate dollar
amount of certain sales of securities (``covered sales''). Rules 31 and
31T, adopted by the Commission in June 2004,\4\ established procedures
for the calculation and collection of Section 31 fees on such covered
sales. Rule 31 requires each national securities exchange that owes
Section 31 fees to submit a completed Form R31 to the Commission each
month, beginning with July 2004. Rule 31T required each exchange to
submit a completed Form R31 for each of the months September 2003 to
June 2004, inclusive. Each national securities exchange must report its
covered sales volume based on the data from a designated clearing
agency, when available. The designated clearing agency for covered
sales of equity securities is the National Securities Clearing
Corporation (``NSCC''). These covered sales are reported in Part I of
Form R31, and each exchange is required to ``provide in Part I only the
data supplied to it by a designated clearing agency.'' \5\ The data
supplied by NSCC for the period September 2003 through August 2004 did
not accurately reflect the aggregate dollar value of the covered sales
occurring on each exchange to permit reports to be made in accordance
with new Rules 31 and 31T. In particular, the data NSCC reported to
each national securities exchange included non-covered sales data for
sales originating on one exchange and executed on another exchange
through the ITS.\6\
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78ee.
    \4\ See Securities Exchange Act Release No. 49928 (June 28,
2004), 69 FR 41060 (July 7, 2004) (``Adopting Release'').
    \5\ 17 CFR 240.31(b)(5).
    \6\ As a result of this and other inaccuracies in the data
reported by NSCC, the national securities exchanges were unable to
report accurate information on Form R31, unless they made
adjustments to the NSCC data based on data other than that provided
by NSCC. On October 6, 2004, the Commission's Division of Market
Regulation (``Division'') issued a ``no-action'' letter advising
exchanges for whom NSCC acts as a designated clearing agency under
Rule 31, that the Division staff would not recommend that the
Commission take enforcement action if a national securities exchange
adjusts the data provided by NSCC to accurately reflect covered
sales occurring on the national securities exchange. See letter from
Robert L.D. Colby, Deputy Director, Division, Commission to Ellen J.
Neely, Senior Vice President and General Counsel, Chicago Stock
Exchange, Inc. (``CHX''), dated October 6, 2004.
---------------------------------------------------------------------------

    Section 31 requires that national securities exchanges pay a fee
based on the aggregate dollar amount of sales of securities transacted
on the exchange. Given the specific language of Section 31, the
Commission in the Adopting Release for Rules 31 and 31T advised that
the current methodology for treating sales of securities that occur
through ITS \7\ was no longer appropriate and that ``it would be
simpler and more transparent for each covered [self-regulatory
organization (``SRO'')] to report all covered sales that occur on its
market.'' The Commission further stated:
---------------------------------------------------------------------------

    \7\ In the Adopting Release, the Commission described the
current methodology: ``SRO A sends an ITS commitment to a member of
SRO B to sell a security, and the commitment is executed on SRO B.
Under existing arrangements, SRO A pays the Section 31 fee arising
from this trade and passes the fee to its member that initiated the
trade. * * * [T]he SROs devised this system because SRO B does not
have the ability to require members of SRO A to reimburse it for the
cost of its Section 31 fees.'' Adopting Release, 69 FR at 41067.

    The Commission acknowledges that a covered SRO on which a
covered sale occurs as a result of an incoming ITS order may not

be able to collect funds to pay the Section 31 fee from one of its
own members. However, Section 31 does not address the manner or
extent to which covered SROs may seek to recover the amounts that
they pay pursuant to Section 31 from their members. Covered SROs may
wish to devise new arrangements for passing fees between themselves
so that the funds are collected from the covered SRO that originated
the ITS order.\8\
---------------------------------------------------------------------------

    \8\ Id.

    The Commission further noted that any such arrangements devised by
the SROs would have to be established pursuant to Section 19(b) of the
Act and Rule 19b-4 thereunder.
    Working through a subcommittee of the ITS Operating Committee \9\
(``Subcommittee''), the national securities exchanges that are ITS
participants devised new arrangements for passing fees between the ITS
participants that were collected from their members. This proposed rule
change is being submitted by Nasdaq based on the substantially similar
rule change proposals submitted by other exchanges participating in the
arrangement.\10\
---------------------------------------------------------------------------

    \9\ The ITS participants are American Stock Exchange LLC, Boston
Stock Exchange (``BSE''), Chicago Board Options Exchange, CHX,
National Association of Securities Dealers (``NASD''), National
Stock Exchange, New York Stock Exchange, Pacific Exchange, and
Philadelphia Stock Exchange. Nasdaq is now also an ITS participant.
    \10\ See, e.g., Securities Exchange Act Release No. 52593
(October 12, 2005), 70 FR 60584 (October 18, 2005) (SR-Amex-2005-
083). NASD determined not to participate in the arrangement for
passing fees between exchanges.
---------------------------------------------------------------------------

    Pursuant to the arrangement, each ITS participant exchange
determines whether it has received and executed more in dollar value of
covered sales than it has originated and sent to each other ITS
participant exchange. For example, for the historical period, September
2003 through August 2004, SRO A sent ITS commitments for covered sales
whose dollar value was $150 million to SRO B for execution. SRO A
collected fees from its members to fund its Section 31 obligation for
those covered sales executed on SRO B. SRO B, as the executing market
center, is obligated to pay the Section 31 fee to the SEC. During the
same period, SRO B sent ITS commitments for covered sales whose dollar
value was $210 million to SRO A. SRO B collected fees from its members
for those covered sales executed on SRO A. SRO A, as the executing
market center, is obligated to pay the Section 31 fee to the SEC. Since
SRO A executed a greater dollar value of covered sales from SRO B than
it sent to SRO B, the proposed arrangement requires SRO A to determine
the amount of the fees collected by SRO B from its members based on the
aggregate dollar value of covered sales from SRO B and executed on SRO
A through ITS commitments. When invoicing SRO B, SRO A will deduct the
amount of the fee it owes to SRO B (i.e., the fee amount based on SRO
A's $210 million in aggregate covered sales less the fee amount based
on SRO B's $150 million in aggregate covered sales) and will invoice
only for the difference of $60 million. The invoicing process under the
arrangement occurs twice yearly to coincide with the March 15 and
September 30 payment schedule for Section 31 fees set forth in the Act.
    To implement this proposed arrangement, an ITS participant exchange
will require access to the aggregate dollar value of buy and sell
transactions occurring through ITS. The Securities Industry Automation
Corporation (``SIAC'') uses the ITS database that it maintains to
provide reports of the aggregate dollar value of buy and sell
transactions occurring through ITS to the ITS participants. The reports
provided by SIAC are used by ITS participants in connection with
determining which ITS participant will pay the fee for transactions
occurring through ITS and which ITS participant has collect the fee
from its members.
    Nasdaq believes that the proposed arrangement is a fair and
efficient means for passing fees collected at one ITS participant
exchange based upon executions of covered sales occurring at another
ITS participant exchange. Nasdaq acknowledges that the legal duty to
report and pay the Section 31 fee remains with the ITS participant on
which the sale was in fact transacted.
2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\11\ in general, and with
Sections 6(b)(4) \12\ and 6(b)(5) \13\ of the Act, in particular, in
that the proposal provides for the equitable allocation of reasonable
dues, fees, and other charges among Nasdaq's members and issuers and
other persons using its facilities, and is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, to remove the impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest. This proposal will allow
Nasdaq to participant in the process established by other SROs to pass
fees they have collected from members for transactions executed on
another SRO through ITS.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f.
    \12\ 15 U.S.C. 78f(b)(4).
    \13\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

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

III. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NASDAQ-2006-010 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2006-010. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in

the Commission's Public Reference Room. Copies of such filing also will
be available for inspection and copying at the principal office of
Nasdaq. 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-
NASDAQ-2006-010 and should be submitted on or before June 15, 2006.

IV. Commission's Findings and Order Granting Accelerated Approval of a
Proposed Rule Change

    After careful consideration, the Commission finds that the proposed
rule change is consistent with the Act and the rules and regulations
thereunder applicable to a national securities exchange.\14\ In
particular, the Commission believes that the proposal is consistent
with Section 6(b)(4) of the Act,\15\ which requires that the rules of
an exchange provide for the equitable allocation of reasonable dues,
fees, and other charges among its members and issuers and other persons
using its facilities. National securities exchanges obtain funds to pay
their Section 31 fees to the Commission by charging fees to broker-
dealers who generate the covered sales on which Section 31 fees are
based. An exchange can obtain most of these funds by imposing a fee on
one of its members whenever the member is on the sell side of a
transaction. However, when the exchange accepts an ITS commitment to
buy, the ultimate seller is a party on another market. The exchange
lacks the ability to pass a fee to that seller directly, because the
seller may not be a member of the exchange. Under the proposed
arrangement, which has been adopted by each of the ITS participant
exchanges other than NASD,\16\ the exchange that routed the ITS
commitment away will continue to collect a fee from the broker-dealer
that placed the sell order. Then, with respect to each ITS participant
exchange, the exchange will determine whether it is a net sender or net
receiver of ITS trades and send fees to or accept fees from each other
exchange accordingly. The Commission believes this is an equitable
manner for the exchanges to obtain funds to pay their Section 31 fees
on covered sales resulting from ITS trades.
---------------------------------------------------------------------------

    \14\ In approving this proposal, the Commission has considered
its impact on efficiency, competition, and capital formation. See 15
U.S.C. 78c(f).
    \15\ 15 U.S.C. 78f(b)(4).
    \16\ See letter from George W. Mann, Jr., Executive Vice
President and General Counsel, BSE, and Chairman, Subcommittee, to
Michael Gaw, Assistant Director, Division, Commission, dated
September 29, 2005.
---------------------------------------------------------------------------

    Under Section 19(b)(2) of the Act,\17\ the Commission may not
approve any proposed rule change prior to the thirtieth day after the
date of publication of the notice of filing thereof, unless the
Commission finds good cause for so doing. The Commission hereby finds
good cause for approving the proposed rule change prior to the
thirtieth day after publishing notice of filing thereof in the Federal
Register. In this case, the Commission does not believe a comment
period is necessary because all of the parties affected by the proposed
fee--the other ITS participant exchanges--have already adopted the same
fee arrangement.\18\
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(2).
    \18\ See supra note 16.
---------------------------------------------------------------------------

    For the reasons set forth above, the Commission finds good cause to
accelerate approval of the proposed rule change pursuant to Section
19(b)(2) of the Act.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that the proposed rule change (SR-NASDAQ-2006-010) is hereby approved
on an accelerated basis.
---------------------------------------------------------------------------

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

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\19\
Nancy M. Morris,
Secretary.
 [FR Doc. E6-7990 Filed 5-24-06; 8:45 am]

BILLING CODE 8010-01-P


From:
"Cornelius, Jay"<EMAIL_ADDRESS>Sent:
Mon, 03 Oct 2022 10:42:43
To:
<EMAIL_ADDRESS><EMAIL_ADDRESS>Donna Jones<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Subject:
ABC Coke - Revision to Fenceline Location

Good morning,
The lack of power supply has necessitated relocation of one of the proposed fenceline monitoring points, F9, to the nearest existing power supply. Please see attached figure and coordinates.

Regards,
Jay Cornelius
ABC Coke

<<ABC Coke-Birmingham_Draft Figure 2_r2.pdf>>
<<ABC Coke-Birmingham_Location Coordinates Table_R1.pdf>>


[Federal Register: April 2, 2008 (Volume 73, Number 64)]
[Notices]
[Page 17973-17975]
[DOCID:fr02ap08-54]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0191; FRL-8355-3]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Application for New and Amended Pesticide
Registration; EPA ICR No. 0277.15, OMB Control No. 2070-0060

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR,
entitled: ``Application for New and Amended Pesticide Registration''
and identified by EPA ICR No. 0277.15 and OMB Control No. 2070-0060, is
scheduled to expire on November 30, 2008. Before submitting the ICR to
OMB for review and approval, EPA is soliciting comments on specific
aspects of the proposed information collection.

DATES: Comments must be received on or before June 2, 2008.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2008-0191, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2008-0191. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov

website to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://
www.regulations.gov, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Cameo Smoot, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What Information is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of PRA, EPA specifically solicits
comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What Should I Consider when I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the collection activity.
    7. Make sure to submit your comments by the deadline identified
under DATES.
    8. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

III. What Information Collection Activity or ICR Does this Action Apply
to?

    Affected entities: Entities potentially affected by this action are
the North American Industrial Classification System (NAICS) codes
assigned to the parties responding to this information, which are
pesticide, fertilizer, and other agricultural chemical manufacturing
(325300).
    Title: Application for New and Amended Pesticide Registration.
    ICR numbers: EPA ICR No. 0277.15, OMB Control No. 2070-0060.
    ICR status: This ICR is currently scheduled to expire on November
30, 2008. 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, are 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: This data collection program is designed to provide EPA
with necessary data to evaluate an application of a pesticide product
as required under section 3 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) and Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended. Under FIFRA, EPA must evaluate pesticides
thoroughly before they can be marketed and used in the United States to
ensure that they will not pose unreasonable adverse effects to human
health and the environment. Pesticides that meet this test are granted
a license or ``registration'' which permits their distribution, sale,
and use according to requirements set by EPA to protect human health
and the environment. An individual or entity wanting to obtain a
registration for a pesticide product must submit an application package
consisting of information relating to the identity and composition of
the product, proposed labeling, and supporting data (or compensation
for others' data) for the product as outlined in 40 CFR part 158. EPA
bases registration decisions for pesticides on its evaluation of a
battery of test data provided primarily by applicants for registration.
Required studies include testing to show whether a pesticide has the
potential to cause unreasonable adverse human health or environmental
effects. The Agency currently collects data on physical chemistry,
toxicology, environmental fate, ecological effects, worker exposure,
residue chemistry, environmental chemistry, and product performance. If
EPA's evaluation of the data shows that the statutory requirements of
FIFRA are met, then a registration is approved. Under FIFRA all
pesticides must be registered by EPA before they may be sold or
distributed in U.S. commerce.
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to range between
14 to 646 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.
    The ICR provides a detailed explanation of this estimate, which is
only briefly summarized here:

    Estimated total number of respondents: 2,100.
    Frequency of response: On occasion.
    Estimated total average burden per response: Ranges from 14 to 646;
depending on type of registration activity.
    Estimated total annual burden hours: 75,922 hours.
    Estimated total annual costs: $ 5,561,258.

IV. Are There Changes in the Estimates from the Last Approval?

    There is a decrease of 77,052 hours (from 152,974 to 75,922) in the
total estimated respondent burden compared with that identified in the
ICR currently approved by OMB. This decrease reflects a decline in the
number of estimated responses, and is due, in part, to EPA's enhanced
ability to more accurately track registration activities via upgraded
database systems. This enhancement has enabled EPA to identify and
eliminate some double-counting of submitted responses. This change is
an adjustment.

V. What is the Next Step in the Process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce
the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the person listed under FOR
FURTHER INFORMATION CONTACT.

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: March 24, 2008.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.

[FR Doc. E8-6672 Filed 4-1-08; 8:45 am]

BILLING CODE 6560-50-S


Significant Excursion Guidance Manual July 2003 Proposal Draft iv Tables and Figures Tables 1. Example 1 1 TTHM and HAA5 Monitoring Data . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2 2.1 Free Chlorine, TTHM, and HAA5 Data for Five Storage Tanks . . . . . . . . . . . . . . . 2 15 Figures 2.1 Effect of NOM Concentration on TTHM and HAA5 Concentration . . . . . . . . . . . . . 2 3 2.2 Impact of Water Temperature on DBP Speciation . . . . . . . . . . . . . . . . . . . . . . . . . . 2 4 2.3 Impact of Bromide on TTHM Speciation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 5 2.4 Effect of pH on TTHM Formation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 6 2.5 Impact of Pre chlorination Dose on In Plant DBP Formation . . . . . . . . . . . . . . . . . . 2 7 2.6 Effect of Disinfectant Residual and Residence Time on TTHM . . . . . . . . . . . . . . . . . 2 9 2.7 Effect of Point of Chlorination on TTHM and HAA5 Concentrations . . . . . . . . . . . 2 10 2.8 Effect of Disinfectant Residual and Residence Time on TTHM . . . . . . . . . . . . . . . . 2 15 2.9 Effect of Point of Chlorination on TTHM and HAA5 Concentrations . . . . . . . . . . . 2 16