[Federal Register Volume 79, Number 157 (Thursday, August 14, 2014)]
[Notices]
[Pages 47651-47653]
[FR Doc No: 2014-19253]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0689]

De Novo Classification Process (Evaluation of Automatic Class III
Designation); Draft Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``De Novo Classification
Process

(Evaluation of Automatic Class III Designation).'' The purpose of this
document is to provide FDA's proposals for guidance to FDA staff and
industry on the process for the submission and review of petitions
submitted under the Evaluation of Automatic Class III Designation
section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act),
also known as the de novo classification process. FDA is issuing this
draft guidance to provide proposed updated recommendations for
efficient interaction with FDA, including what information to submit
when seeking a path to market for a novel device via the de novo
process. This draft guidance has been revised and is being reissued for
comment because the Food and Drug Administration Safety and Innovation
Act (FDASIA), which became law on July 9, 2012, amended the FD&C Act to
provide for the submission of de novos without a preceding premarket
notification (510(k)) submission. This draft guidance is not final nor
is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 14, 2014. Submit either electronic or written
comments concerning proposed collection of information by October 14,
2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``De Novo Classification Process (Evaluation
of Automatic Class III Designation)'' to the Office of the Center
Director, Guidance and Policy Development, Center for Devices and
Radiological Health (CDRH), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002, or to
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Melissa Burns, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1646, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    A medical device that is of a new type that FDA has not yet
classified, and therefore cannot be found to be substantially
equivalent to a legally marketed predicate device, is ``automatically''
or ``statutorily'' classified into class III by operation of section
513(f)(1) of the FD&C Act (21 U.S.C. 360c(f)(1)) even if the risks it
presents are relatively low. This is the scenario contemplated by
Congress when it enacted section 513(f)(2) of the FD&C Act (21 U.S.C.
360c(f)(2)) as part of the Food and Drug Administration Modernization
Act of 1997 (FDAMA). The process created by this provision is referred
to in FDAMA as the Evaluation of Automatic Class III Designation (e.g.,
the de novo process). Congress included this section to limit
unnecessary expenditure of FDA and industry resources that could occur
if lower risk devices were subject to premarket approval under section
515 of the FD&C Act (21 U.S.C. 360e).
    Section 513(f)(2) of the FD&C Act was amended again by Congress
under section 607 of FDASIA (Pub. L. 112-144) in 2012. Section
513(f)(2) provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1) of
the FD&C Act. Under the first procedure, the person submits a premarket
notification under section 510(k) of the FD&C Act for a device that has
not previously been classified and, after receiving an order
classifying the device into class III under section 513(f)(1), the
person requests a classification under section 513(f)(2) of the FD&C
Act. Under the second procedure, rather than first submitting a
premarket notification under section 510(k) of the FD&C Act 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) of the FD&C Act.
    On October 3, 2011, FDA published a notice of availability of a
draft guidance document on the de novo classification process (76 FR
61103). The comment period closed on December 2, 2011. After the
passage of FDASIA in 2012 added a procedure by which a person may
request FDA to classify a device under 513(f)(2) of the FD&C Act, FDA
decided it should revise the 2011 draft guidance to include
recommendations regarding the second procedure. Accordingly, FDA is
issuing this draft guidance to provide updated proposed recommendations
designed to foster efficient interaction with FDA, including what
information to submit, when seeking a path to market via the de novo
process. This draft guidance describes a proposed mechanism to provide
greater clarity about the process for de novo review and the type of
data necessary to support de novo classification of an eligible device.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the de novo
classification process. It does not create or confer any rights for or
on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at
http://www.regulations.gov or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to download an electronic copy of ``De Novo
Classification Process (Evaluation of Automatic Class III
Designation)'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document. Please use the document
number 1769 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (44 U.S.C. 3501-3502), Federal
Agencies

must obtain approval from the Office of Management and Budget (OMB) for
each collection of information they conduct or sponsor. ``Collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes Agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c) (2)(A) of the PRA (44 U.S.C. 3506 (c) (2)(A)) requires
Federal Agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information before submitting
the collection to OMB for approval. To comply with this requirement,
FDA is publishing notice of the proposed collection of information set
forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Draft Guidance for Industry and Food and Drug Administration Staff: De
Novo Classification Process (Evaluation of Automatic Class III
Designation)
    This draft guidance describes how CDRH and CBER intend to implement
section 513(f)(2) of the FD&C Act. Section 513(f)(2) provides two
procedures by which a person may request FDA to classify a device under
the criteria set forth in section 513(a)(1) of the FD&C Act. Under the
first procedure (section 513(f)(2)(i)), the person submits a premarket
notification under section 510(k) of the FD&C Act for a device that has
not previously been classified and, after receiving an order
classifying the device into class III under section 513(f)(1), the
person requests a classification under section 513(f)(2) of the FD&C
Act. Under the second procedure (section 513(f)(2)(ii) of the FD&C
Act), rather than first submitting a premarket notification under
section 510(k) of the FD&C Act 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) of the FD&C Act. When final, this document will supersede
``New Section 513(f)(2)--Evaluation of Automatic Class III Designation,
Guidance for Industry and CDRH Staff'' dated February 19, 1998.
    The proposed collections of information are necessary to satisfy
the previously mentioned statutory requirements for implementing this
voluntary submission program.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
Submission of information for de     Number of     responses per   Total annual   per respondent    Total hours
   novo classification program      respondents     respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
CDRH (21 U.S.C. 513(f)(2)(i))...              25               1              25             100           2,500
CBER (21 U.S.C. 513(f)(2)(i))...               1               1               1             100             100
CDRH (21 U.S.C. 513(f)(2)(ii))..              25               1              25             180           4,500
CBER (21 U.S.C. 513(f)(2)(ii))..               1               1               1             180             180
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           7,280
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Respondents are medical device manufacturers seeking to market
medical device products that have been classified into class III under
section 513(f)(2) of the FD&C Act. Based on FDA's experience with the
de novo classification program, FDA expects the program to continue to
be utilized as a viable program in the future. It is expected that the
number of de novos will increase over its current rate and reach a
steady rate of approximately 50 submissions per year.
    FDA estimates from past experience with the de novo petition
program that the complete process involved with the program under
section 513(f)(2)(i) of the FD&C Act takes approximately 100 hours. FDA
estimates from past experience with the de novo petition program that
the complete process involved with the program under section
513(f)(2)(i)(ii) FD&C Act takes approximately 180 hours. This average
is based upon estimates by FDA administrative and technical staff who
are familiar with the requirements for submission of a de novo petition
(and related materials), have consulted and advised manufacturers on
these requirements, and have reviewed the documentation submitted.
Therefore, the total reporting burden hours is estimated to be 7,280
hours.
    This draft guidance also refers to currently approved information
collections found in FDA regulations. The collections of information in
21 CFR part 807, subpart E, are approved under OMB control number 0910-
0120.

V. Comments

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

    Dated: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19253 Filed 8-13-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 89 (Tuesday, May 11, 2021)]
[Notices]
[Page 25852]
[FR Doc No: 2021-09932]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER21-1838-000]

Orangeville Energy Storage LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced Orangeville
Energy Storage LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is May 25, 2021.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: May 5, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-09932 Filed 5-10-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: May 24, 2007 (Volume 72, Number 100)]
[Notices]
[Page 29142-29143]
[DOCID:fr24my07-47]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. QF07-11-000]

EnviroDyne Inc.; Notice of Filing of Notice of Self-Certification
of Qualifying Status of a Cogeneration Facility

May 18, 2007.
    Take notice that on October 13, 2006, EnviroDyne Inc., 10400
Overland Road 226, Boise, ID 83709 filed with the Federal
Energy Regulatory Commission a notice of self-certification of a
facility as a qualifying cogeneration facility pursuant to 18 CFR
292.207(a) of the Commission's regulations.
    This cogeneration facility will be located at 3349 S. 1800 E.,
Wendell, Gooding County, Idaho.

    Initially the primary energy input will be from Natural Gas fuel
with approximately one percent (1%) of the fuel source from Diesel Fuel
(pilot fuel for ignition of the natural gas).
    It is anticipated that over time, after development of a
gasification unit, this plant could be run on the output of a
gasification process with animal waste being the input to the energy
conversion units. This fuel source would be in addition to operation on
Bio-diesel fuel. In the event of lack of this fuel, the units would run
on or be supplemented by Natural Gas.
    The principle components of the plant will consist of six (6) model
38ETDD81/8 Enviro-Design Engines, each rated at 3030 BHP and each
capable of producing 2165 KW power at 4160 volt, 3 phase 60 Hz
Alternating Current. In addition to each engine-generator unit, each
plant will consist of heat exchangers and radiators as necessary to
cool the units and to recover heat from the units in the form of hot
water, possible including exhaust waste heat boilers/heat exchangers.
Units would also each include lube oil filtration equipment. Switch
gear necessary to monitor and control power output would be included,
with each unit having a brushless exciter system controlled by a
voltage regulation system.
    The plant will also be provided with a step up transformer to
convert the generator output (at 4160 VAC) to 35 KV power for
connection to Idaho Power's nearby transmission line.
    It is expected that EnviroDyne will interconnect with and sell
electricity to IDAHO POWER.
    EnviroDyne Inc. will not receive supplementary power, backup power,
maintenance power, and/or interruptible power from any utility.
EnviroDyne Inc. will be a self-sustaining power generation facility.
    A notice of self-certification does not institute a proceeding
regarding qualifying facility status; a notice of self-certification
provides notice that the entity making filing has determined the
Facility meets the applicable criteria to be a qualifying facility. Any
person seeking to challenge such qualifying facility status may do so
by filing a motion pursuant to 18 CFR 292.207(d)(iii).
    This filing is accessible on-line at http://www.ferc.gov, using the

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

TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-9972 Filed 5-23-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 208 (Thursday, October 27, 2011)]
[Rules and Regulations]
[Pages 66615-66617]
[FR Doc No: 2011-27773]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0792; Directorate Identifier 2009-SW-19-AD;
Amendment 39-16762; AD 2011-16-04]
RIN 2120-AA64

Airworthiness Directives; Sikorsky Aircraft Corporation
(Sikorsky) Model S-92A Helicopters

AGENCY: Federal Aviation Administration, DOT.

ACTION: Final rule; request for comments.

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SUMMARY: This amendment adopts a new airworthiness directive (AD) for
Sikorsky Model S-92A helicopters. This action requires making pen and
ink changes, inserting a copy of this AD, or inserting specified
temporary revisions into the Limitations section of the Rotorcraft
Flight Manual (RFM) limiting the maximum rolling groundspeed for a
normal landing or takeoff from 65 knots to 50 knots for helicopters
with a certain serial-numbered landing gear retract actuator
(actuator). Instead of limiting the groundspeed, replacing the affected
actuator with a modified actuator is terminating action for the
requirements of this AD. This amendment is prompted by a report of a
main landing gear that would not retract. The manufacturer reports that
certain actuators were manufactured with down-lock keys that did not
meet the specified minimum hardness requirements. This condition, if
not corrected, could lead to a landing gear collapse following a roll-
on landing that exceeds 50 knots groundspeed. These actions are
intended to prevent collapse of a landing gear and subsequent loss of
control of the helicopter.

DATES: Effective November 14, 2011.
    Comments for inclusion in the Rules Docket must be received on or
before December 27, 2011.

ADDRESSES: Use one of the following addresses to submit comments on
this AD:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    You may get the service information identified in this AD from
Sikorsky Aircraft Corporation, Attn: Manager, Commercial Technical
Support, mailstop s581a, 6900 Main Street, Stratford, CT, telephone
(203) 383-4866, e-mail address<EMAIL_ADDRESS>or at http://www.sikorsky.com.
    Examining the Docket: You may examine the docket that contains the
AD, any comments, and other information on the Internet at http://www.regulations.gov, or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The Docket Operations office (telephone<PHONE_NUMBER>) is
located in Room W12-140 on the ground floor of the West Building at the
street address stated in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Michael Schwetz, Aviation Safety
Engineer, Boston Aircraft Certification Office, 12 New England
Executive Park, Burlington, MA 01803, telephone<PHONE_NUMBER>, fax
(781) 238-7170.

SUPPLEMENTARY INFORMATION: This amendment adopts a new AD for Sikorsky
Model S-92A helicopters. This action requires making pen and ink
changes, inserting a copy of this AD, or inserting certain temporary
revisions into the Limitations section of the RFM limiting the maximum
groundspeed for a normal landing or takeoff to 50 knots for helicopters
with a certain serial-numbered actuator installed. The temporary
revisions to the Limitations section of the RFM also require replacing
the actuators if the landing exceeds the 50 knot rolling groundspeed
before further flight or before towing the helicopter; rolling ground
taxi operations are permitted. Replacing the affected actuator with a
modified actuator is terminating action for the requirements of this
AD. The manufacturer states that it anticipates retrofitting the fleet
with a modified actuator within 3 years. This amendment is prompted by
a report that certain actuators were manufactured

with a down-lock pin that does not meet the specified minimum hardness
requirements, which could lead to a landing gear collapse following a
roll-on landing that exceeds 50 knots. These actions are intended to
prevent a landing gear collapse and subsequent loss of control of the
helicopter.
    We have reviewed Sikorsky Alert Service Bulletin No. 92-32-001,
dated May 2, 2008 (ASB), which describes the unsafe condition, its
cause, and the temporary operating restrictions intended to mitigate
the unsafe condition until modified actuators are available. The ASB
references and includes Embraer Liebherr Eqiupamentos do Brasil Service
Bulletin No. 2392-0850-32-02 Change No. 1, dated May 15, 2008, which
specifies procedures for replacing the down-lock key in the affected
actuators.
    This unsafe condition is likely to exist or develop on other
helicopters of the same type design. Therefore, this AD is being issued
to limit the maximum rolling groundspeed for a normal landing or
takeoff to 50 knots rolling groundspeed. If the limitation is exceeded
on landing, the actuator must be replaced with a modified actuator
before further flight or towing operation; rolling ground taxi
operations are permitted. This AD requires making pen and ink changes,
inserting a copy of this AD, or inserting the following temporary
revisions into the Limitations section of the RFM: SA S92A-RFM-000,
Revision 2; SA S92A-RFM-002, Revision 6; SA S92A-RFM-003, Revision 5;
SA S92A-RFM-004, Revision 5; SA S92A-RFM-005, Revision 4; or SA S92A-
RFM-006, Revision 3; all approved on January 7, 2011. Instead of
limiting the groundspeed, replacing each actuator without the
modification letter ``B'' stamped on the nameplate with an airworthy
modified actuator with a letter ``B'' stamped on the nameplate
constitutes terminating action for the requirements of this AD.
    The short compliance time of before further flight is required
because the previously described critical unsafe condition can
adversely affect the structural integrity and controllability of the
helicopter. Therefore, limiting the maximum groundspeed for normal
landing or takeoff to 50 knots to reduce the likelihood of a landing
gear collapse is required before further flight and this AD must be
issued immediately.
    Since a situation exists that requires the immediate adoption of
this regulation, it is found that notice and opportunity for prior
public comment hereon are impracticable and that good cause exists for
making this amendment effective in less than 30 days.
    We estimate that this AD will affect 42 helicopters. It will take a
minimal amount of time to make the limitation changes. If the operator
replaces an affected actuator with a modified actuator, it will take
about 8 work hours at an average labor rate of $85 per work hour.
Required parts will cost about $7,841 per helicopter. Based on these
figures, we estimate the total cost impact of the AD on U.S. operators
to be $357,882, assuming all the helicopter operators install modified
actuators.

Comments Invited

    This AD is a final rule that involves requirements that affect
flight safety and was not preceded by notice and an opportunity for
public comment; however, we invite you to submit any written data,
views, or arguments regarding this AD. Send your comments to an address
listed under ADDRESSES. Include ``Docket No. FAA-2011-0792; Directorate
Identifier 2009-SW-19-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of the AD. We will consider all
comments received by the closing date and may amend the AD in light of
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this AD. Using the search function of our
docket Web site, you can find and read the comments to any of our
dockets, including the name of the individual who sent the comment. You
may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19477-78).

Regulatory Findings

    We have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect on the States, on the relationship between
the national Government and the States, or on the distribution of power
and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that the regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD. See the AD docket to examine the economic evaluation.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration amends part 39 of
the Federal Aviation Regulations (14 CFR part 39) as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. Section 39.13 is amended by adding a new airworthiness directive to
read as follows:

2011-16-04 Sikorsky Aircraft Corporation: Amendment 39-16762. Docket
No. FAA-2011-0792; Directorate Identifier 2009-SW-19-AD.

    Applicability: Model S-92A helicopters with landing gear retract
actuator (actuator), part number (P/N) 92250-00800-103, with a
serial number (S/N) 101-00026 through 101-00237, without the
modification letter ``B''

stamped on the nameplate, certificated in any category.
    Compliance: Before further flight, unless previously
accomplished.
    To prevent a landing gear collapse and subsequent loss of
control of the helicopter, do the following:
    (a) Revise the operating limitations, ``Airspeed Limits''
section of the rotorcraft Flight Manual (RFM) by one of the
following methods:
    (1) Insert Sikorsky ``Temporary Revisions'' SA S92A-RFM-000,
Revision 2; SA S92A-RFM-002, Revision 6; SA S92A-RFM-003, Revision
5; SA S92A-RFM-004, Revision 5; SA S92A-RFM-005, Revision 4; or SA
S92A-RFM-006, Revision 3; all approved January 7, 2011; or
    (2) Insert a copy of this AD; or
    (3) Make pen and ink changes with the following limitations:
    ``Maximum rolling groundspeed for normal takeoff or normal
landing is 50 knots.''
    ``After a landing with a rolling groundspeed in excess of 50
knots, any further takeoffs or towing operation is prohibited.
Rolling ground taxi operations of less than 50 knots are
permitted.''
    (b) Following a landing with a rolling groundspeed in excess of
50 knots, or as an alternative to revising the operating limitations
section of the RFM in compliance with this AD, before further
flight, replace each affected actuator that does not have the
modification letter ``B'' stamped on the nameplate with an airworthy
actuator that has the modification letter ``B'' stamped on the
nameplate.
    (c) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Contact the Manager, Boston Aircraft Certification Office, FAA,
ATTN: Michael Schwetz, Aviation Safety Engineer, 12 New England
Executive Park, Burlington, MA 01803, telephone<PHONE_NUMBER>, fax
(781) 238-7170, for information about previously approved
alternative methods of compliance.

    Note: Sikorsky Alert Service Bulletin No. 92-32-001, dated May
2, 2008, which is not incorporated by reference, contains additional
information about the subject of this AD.

    (d) The Joint Aircraft System/Component (JASC) Code is 3233:
Landing Gear Actuator.
    (e) This amendment becomes effective on November 14, 2011.

    Issued in Fort Worth, Texas, on July 14, 2011.
Kim Smith,
Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2011-27773 Filed 10-26-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: July 11, 2007 (Volume 72, Number 132)]
[Notices]
[Page 37748-37749]
[DOCID:fr11jy07-62]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket No. RP00-632-023]

Dominion Transmission, Inc.; Notice of Fuel Report

July 3, 2007.
    Take notice that on June 27, 2007, Dominion Transmission, Inc.
(DTI) tendered for filing its informational fuel report. DTI states
that the fuel report details DTI's System Gas Requirements and gas
retained or otherwise obtained for the twelve-month period ending March
31, 2007.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed on or before the date as indicated below. Anyone filing a
protest must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

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

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

(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on July 10, 2007.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-13463 Filed 7-10-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 151 (Monday, August 6, 2018)]
[Notices]
[Page 38296]
[FR Doc No: 2018-16746]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC18-76-000.
    Applicants: Entergy Arkansas, Inc., Entergy Mississippi, Inc.
    Description: Supplement to March 27, 2018 Joint Application of
Entergy Arkansas, Inc., et al. for Approval under Section 203 of the
Federal Power Act.
    Filed Date: 7/27/18.
    Accession Number: 20180727-5212.
    Comments Due: 5 p.m. ET 8/10/18.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG18-116-000.
    Applicants: Live Oak Wind Project, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Live Oak Wind Project, LLC.
    Filed Date: 7/31/18.
    Accession Number: 20180731-5034.
    Comments Due: 5 p.m. ET 8/21/18.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-3279-002; ER10-3275-002; ER10-3274-002; ER18-
213-001; ER10-3278-002.
    Applicants: Basin Creek Equity Partners L.L.C., Capitol District
Energy Center Cogeneration Associates, Pawtucket Power Associates
Limited Partnership, Pittsfield Generating Company, L.P., Forked River
Power LLC.
    Description: Notice of Non-Material Change in Status of Basin Creek
Equity Partners L.L.C., et. al.
    Filed Date: 7/30/18.
    Accession Number: 20180730-5275.
    Comments Due: 5 p.m. ET 8/20/18.

    Docket Numbers: ER15-794-008.
    Applicants: Catalyst Paper Operations, Inc.
    Description: Notification of Change in Status of Catalyst Paper
Operations, Inc.
    Filed Date: 7/30/18.
    Accession Number: 20180730-5250.
    Comments Due: 5 p.m. ET 8/20/18.

    Docket Numbers: ER18-2049-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Tariff Amendment: 2018-07-30_Amendment to Attachment X
Revisions to Expedite Phase I of the DPP to be effective 9/19/2018.
    Filed Date: 7/30/18.
    Accession Number: 20180730-5233.
    Comments Due: 5 p.m. ET 8/20/18.

    Docket Numbers: ER18-2104-000.
    Applicants: Arizona Public Service Company.
    Description: Sec.  205(d) Rate Filing: Rate Schedule No. 217,
Exhibit A and Exhibit B Revisions to be effective 10/1/2018.
    Filed Date: 7/30/18.
    Accession Number: 20180730-5227.
    Comments Due: 5 p.m. ET 8/20/18.

    Docket Numbers: ER18-2105-000.
    Applicants: Arizona Public Service Company.
    Description: Sec.  205(d) Rate Filing: Revisions to Service
Agreement Nos. 218 and 335 to be effective 7/1/2018.
    Filed Date: 7/30/18.
    Accession Number: 20180730-5229.
    Comments Due: 5 p.m. ET 8/20/18.

    Docket Numbers: ER18-2106-000.
    Applicants: Duke Energy Ohio, Inc.
    Description: Sec.  205(d) Rate Filing: Duke-DP&L IA 205 Filing (PJM
SA No. TBD) to be effective 6/30/2018.
    Filed Date: 7/30/18.
    Accession Number: 20180730-5238.
    Comments Due: 5 p.m. ET 8/20/18.

    Docket Numbers: ER18-2107-000.
    Applicants: Duke Energy Ohio, Inc.
    Description: Sec.  205(d) Rate Filing: Duke-AEP IA 205 Filing (PJM
SA No. 1491) to be effective 6/30/2018.
    Filed Date: 7/30/18.
    Accession Number: 20180730-5239.
    Comments Due: 5 p.m. ET 8/20/18.

    Docket Numbers: ER18-2108-000.
    Applicants: Duke Energy Ohio, Inc.
    Description: Sec.  205(d) Rate Filing: Duke-EKPC IA 205 Filing (PJM
SA No. 3141) to be effective 6/30/2018.
    Filed Date: 7/30/18.
    Accession Number: 20180730-5240.
    Comments Due: 5 p.m. ET 8/20/18.

    Docket Numbers: ER18-2109-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: 2nd Quarter 2018 Revisions
to OA, Sch. 12 and RAA, Sch. 17 Member Lists to be effective 6/30/2018.
    Filed Date: 7/31/18.
    Accession Number: 20180731-5059.
    Comments Due: 5 p.m. ET 8/21/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 31, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-16746 Filed 8-3-18; 8:45 am]
 BILLING CODE 6717-01-P


Response to Comments Received After Second Federal Register Notice
1) The first commenter describes in detail the policy background for the South reach of the Santa Cruz River, stressing lack of control that Arizona has over most of that effluent, which is actually owned by Sonora, Mexico. The commenter expresses support for the survey research as an opportunity to proactively evaluate options. There were no statements requesting a response.
2) The second commenter also notes the potential for changes to the South reach of the Santa Cruz River, and the importance of gaining an accurate sense of how residents and tourists value the natural resources. The commenter states that a monetized value elicited by the survey should not be the only basis for assessing value. The principal investigator agrees that the survey should be only one of numerous considerations and sources of information to support local decision-making.
3) The third commenter submitted a comment after the comment period closed. The commenter references in some places a conversation held with the principal investigator (PI). As further background, the principal investigator (PI) became aware of the concerns of this commenter late in the comment period and phoned a representative immediately to discuss the research project since the public review period was close to ending. The PI furthermore offered to be available for follow-up conversations while the commenter reviewed the project more closely, but the PI did not hear from the commenter again. Unfortunately the single conversation was incomplete and had led to some misunderstandings, evident in mischaracterization of the research and mischaracterization of statements the PI made.
While below there are detailed responses to the specific comments, an overall response may also be useful to describe the project and its purpose. The objective of the survey is to contribute to research on how people value river ecosystems in the arid southwest, with the Santa Cruz River as a case study in this regard. The survey and survey design reflect an extended period of careful study of Santa Cruz River management options and pretesting of the survey instrument, as described at length in the supporting statement (see especially Part B, section 3). The survey is an example of best practice methods in willingness to pay survey research to estimate value for the scenarios posed. The survey strategically considers a range of effluent management possibilities for the Santa Cruz River and is not intended to provide a complete cost-benefit analysis of any particular Santa Cruz River effluent management option. The economic information the survey would provide is designed to be useful for management insight, but would be incomplete for any given effluent management option for several reasons: the willingness to pay survey design considers a discrete set of marginal changes for a discrete set of variables; the survey focuses on urban populations; and there are several additional types of economic analyses possible, such as estimating the cost of increasing the level of treatment to actually allow safe full body contact.
The commenter raises several good questions, some of which are commonly asked of willingness to pay survey research methods. Some of the responses will duplicate responses made to comments received in the first round of comments found in the supporting statement part 3(c) or other material provided in the supporting statement. The full text of the comments is responded to below, organized by four points in the federal register that EPA requested comments on. EPA solicited 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 estimate 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; and (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.
EPA Question 1 for commenters:
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.
Comment 1.1 from Tumacácori National Historical Park:
We strongly urge the author to consider what we feel is a flawed emphasis on increasing survey response at the expense of facts; and also consider ways that this study may be used in the future as a tool in directing management action or in influencing public opinion in ways for which it is not designed or suitable.
We understand the current fiscal restraints placed on federal agencies that challenge our capacity to achieve agency and operational objectives. As a fellow federal agency, we understand the conflict between these challenges and desire to get the job done. However, we strongly object to including statements in the survey that the author knows are not factual to increase the response rate, and to limiting the distribution of the survey to the Tucson and Phoenix metropolitan areas strictly to assure an adequate sample size.
Response to Comment 1.1 from Tumacácori National Historical Park:
The comment mischaracterizes the survey research as an attempt to mislead survey respondents. The PI believes the commenter is referring to the consequentialist language in the survey, a best practices technique in willingness to pay survey design. Consequentialist language emphasizes that respondents' survey responses matter. This is not a response rate issue but an issue of limiting potential bias in responses due to strategic behavior. This issue is treated in more depth below in the more specific comment made later, comment 1.5.
One of the motivations of the survey is in fact that it may provide management insight. The survey is not a tool to influence public opinion, but rather a tool to proactively collect public opinion.
The decision to sample Tucson and Phoenix are driven by the urban emphasis of the research project, not in order to assure an adequate sample size.
Comment 1.2 from Tumacácori National Historical Park:
Pursuant to this we offer the following points:
   * The survey vastly oversimplifies the scenarios to the point that the resulting data will be of minimal value. For example, the survey does not adequately describe impacts of the various proposed scenarios, such as that the diversion of water away from the river will result in sharply declining groundwater levels throughout the upper Santa Cruz river basin.
Response to Comment 1.2 from Tumacácori National Historical Park:
The scenarios in the survey were carefully refined and pretested over a lengthy sequence of meetings with urban residents in southern Arizona, in two phases. Preceding these pretests of the survey instrument were several focus groups collecting public perspectives on rivers and streams in southern Arizona, including the Santa Cruz River.
The survey is not intended as a tool to estimate the value of changes in groundwater levels. For the flow & forest variable, the survey is designed to value changes in length of surface flow and acres of forest.
Comment 1.3 from Tumacácori National Historical Park:
   * There is no indication that the scenarios included in the survey are economically feasible or even physically possible, but the scenarios are posed without discussion of these uncertainties. For example, recent upgrades to the Nogales International Wastewater Treatment Plant (NIWTP) have greatly improved the water quality of the effluent, especially the nutrient levels. The NPS supports this and any other initiatives to improve the water quality. There is currently, and likely for the near future, unique features of the waste stream entering the NIWTP that make assuring that the water is safe to swim, or even wade in, nearly impossible. Much of the source of the effluent at the NIWTP if from Nogales Mexico, and is thus outside the jurisdiction of American environmental regulation. Water in the waste stream from Nogales Mexico and effluent from the treatment plant has been detected with concentrations of metals such as chromium, cadmium and lead that exceed Arizona and federal standards. Mitigation of theses metals and other compounds, like emerging contaminants (e.g., pharmaceuticals) detected in the effluent is currently not possible -- treatment is cost prohibitive or not currently feasible.
Response to Comment 1.3 from Tumacácori National Historical Park:
That source waters of the Santa Cruz River cross jurisdictions does not mean that changing the water quality of the Santa Cruz River is not a management possibility. The Arizona Department of Environmental Quality, Office of Border Environmental Protection (OBEP) website states (http://www.azdeq.gov/obep/, accessed 11/25/2013): "OBEP's emphasis is on cross-border or transboundary issues that impact Arizona's environment and its citizens. This entails working in a binational and bicultural setting to facilitate efforts aimed at improving air quality, waste management and water quality conditions in Arizona border communities." The scenarios were built to reflect changes in ecological attributes of high interest to the public (as collected through the focus groups and pretesting) and were also constructed to be plausible. Regarding the safe full body contact option described in the survey, it would not be possible to know if further effluent treatment or pollutant prevention measures are cost-effective without having a sense of what public values for increases in water quality are.
The survey does not attempt to include actual costs for the scenarios posed. Instead the payment levels in the choice experiment design are derived from survey pretesting, and are designed to bracket willingness to pay for the different scenarios. These payment levels would be updated based on the pilot survey (as described in the survey methodology supporting statement Part B, section 3) to refine their ability to bracket willingness to pay. Estimating costs of the scenarios is a different research question that would require different techniques.
Comment 1.4 from Tumacácori National Historical Park:
   * The principal investigator has verbally indicated to my staff that the purpose of the study is to "understand how people value rivers in the southwest" (in general). However, this study specifically addresses two effluent-dominated reaches which are in no conceivable way representative of the majority of rivers in the southwest, and the responses to the survey will not be relevant to the wider question of southwest rivers.
Response to Comment 1.4 from Tumacácori National Historical Park:
The objective of the survey is to contribute to research on how people value river ecosystems in the arid southwest, and the Santa Cruz River is a case study in this regard. Indeed there are a number of important differences between the effluent-dominated reaches of the Santa Cruz River and other rivers and streams in the southwest. For a variety of reasons it would not be possible to take the results from this study and apply them directly to management scenarios for any river in the southwest. However there may be insights for similar management contexts in the arid southwest beyond the case study. The techniques for utilizing valuation survey results for new contexts are a topic in the "benefit transfer" literature. A full discussion of that literature and those techniques is best left to other sources. The research report would clearly describe the management context for the case study: this information would be important both for interpretation of the case study results, as well as considering how the results may or may not provide insight into other management contexts.
Comment 1.5 from Tumacácori National Historical Park:
   * The survey indicates that a vote in this survey will lead to subsequent relevant management action. According to the principal investigator, this is not the case. The non-binding and pure research nature of this survey should be clearly indicated and any text/graphics with this inference (e.g., pg. 6) should be removed or altered. It is stated that on page 11 of the survey instrument that, "This survey is similar to a public vote". This statement leads the survey participant to believe that the results of this survey are somehow formal in nature and will lead to a management action when in fact there is no "vote" being taken nor are any results being immediately considered by any management agency as a result of this survey, as per conversations with the author. According to the principal investigator, the survey is for academic research purposes with a goal of publication in a scholarly journal and was not conceived to specifically or primarily affect management decisions. This fact should be clearly and explicitly stated.
Response to Comment 1.5 from Tumacácori National Historical Park:
While there is no specific management action this survey is designed to address, the text in the survey is designed to be consequential for respondents. This follows best practices of willingness to pay techniques (Carson and Groves, 2007, Environ Resource Econ, 37:181-210; Vossler et al., 2011, American Economic Journal, 4(4): 145-171). This is not an issue of response rate (although low response rates increase the danger of non-response bias) but in order to limit biased responses due to strategic behavior. Unrealistically high willingness to pay choices could be made if respondents don't believe they will actually have to bear the costs they are indicating a willingness to pay for. Consequentiality cannot be sacrificed without losing the goal of the survey to estimate values for the scenarios posed. The study is being designed to the standards of peer-reviewed literature, not to distance its usefulness for policy applications, but to ensure its rigor. It is a mischaracterization of the research to say that it is not designed to be informative for management decisions; however it is accurate to say that there is no single and specific management change the survey is designed to address. The following changes have been made to ensure that the survey is not viewed as an immediate actual vote, but also maintain consequentiality: Page 2, 1[st] paragraph: "Your responses will help authorities select the best option." to "This survey is designed to help authorities select the best option."; Page 6, 1[st] paragraph (two instances): "This survey will help managers know..." to "This survey is designed to help managers know..."; Page 13, 3[rd] bullet: "Your votes are important and will help determine the best option for the Santa Cruz River." to "Your votes are important and voting questions are designed to help determine the best option for the Santa Cruz River."; new question after Q10, "Thinking about how you responded in Q2 through Q5, would you choose the same options in an actual public vote?", with a five point scale having options of strongly disagree, disagree, neither agree nor disagree, agree, and strongly agree.
Comment 1.6 from Tumacácori National Historical Park:
   * The survey indicates that results will be used by "authorities" to "select the best option". It states that it is important to "hear from all perspectives", but the sample base constitutes major urban centers, only one of which is truly in southern Arizona. Rural and Santa Cruz County populations are not sampled. The principal investigator has stated that he assumes that residents of Santa Cruz County will have the same opinions as those of Tucson, but other comments he made indicate that this was done for ease of implementation alone.
Response to Comment 1.6 from Tumacácori National Historical Park:
The consequentialist text on page 2, as described in the previous response, would read: "This survey is designed to help authorities select the best option." The importance of hearing from all perspectives is stressed early in the survey to ensure it is clear that no particular type of response (i.e. environmentalist or non-environmentalist) is sought. The survey research design in the supporting statement clearly states that the targeted samples are urban populations of the Tucson and Phoenix areas. The project design investigates urban values for the resources, and furthermore compares value estimates of an urban population close to the resources with an urban population distant from the resources. The research design has an urban emphasis, which is in influenced by the high percentage of persons in southern Arizona living in urban areas. If one considers all of the counties of southern Arizona (Cochise, Gila, Graham, Greenlee, La Paz, Maricopa, Pima, Pinal, and Yuma), the census-designated urbanized areas of just Tucson and Phoenix/Mesa account for 79% of the population (Census 2010, and http://www2.census.gov/geo/ua/ua_st_list_all.txt, accessed 11.25.2013). The urban emphasis of this project is not meant to indicate rural populations should not be studied in other research designs or are unimportant, but rather just denotes the boundaries of the study. The principal investigator has not stated that residents of Santa Cruz County will have opinions "the same" as those in Tucson. This false impression may have occurred in the course of describing that from an aggregate valuation standpoint, it is likely more informative to sample urban populations such as Tucson and Phoenix. The project has had an emphasis on investigating urban values from the beginning; the design boundaries of this study will be included in project reporting.
Comment 1.7 from Tumacácori National Historical Park:
We understand that some current methods for conducting surveys suggest that response rates can be increased by making the respondent feel that by responding they can affect immediate change. We also understand the importance of a valid sample size to scientific studies.
Tumacácori NHP continues to be a vital and vibrant focal point for celebrating the cultures and communities, past and present, associated with the Santa Cruz River valley. As an agency we take seriously our core mission of conserving our natural and cultural resources. We strongly feel that if the survey cannot be conducted using facts or even give a voice to the people that live along the resource, due to budget, manpower or time limitations, then it should not be conducted until the needed resources are available.
We feel that although the survey would be useful, the attempts at sampling efficacy of the current survey have created a deeply flawed instrument, and in current form will not produce results that will be of real "practical utility".
We also urge the author to consider that in the future, this study and its conclusions will be viewed by the public as scientifically rigorous and sanctioned by the EPA, a prominent federal agency tasked with protecting the environment. Whatever the outcome of the study, this association with the EPA will add a gravitas to the study that would not exist if it was conducted by another entity such as a university or an NGO with no government affiliation. The results of this survey may be used by any number of groups for scientific, community or political purposes that could have an impact on Tumacácori NHP and other stakeholders of the Santa Cruz River corridor. We urge extreme care in the design of this survey.
Response to Comment 1.7 from Tumacácori National Historical Park:
The PI agrees that the survey expresses to respondents that their input matters. This is a common feature of survey research and was intentional.
The PI believes there is a role for collecting public input regarding management of public resources. To be proactive in collecting public input on a variety of potential effluent management actions the PI has constructed potential management scenarios and emphasized in the survey that public input is important in deciding among them. The PI is not in need of additional resources to conduct the research study as proposed.
The PI has followed best practices for willingness to pay survey design and has extensively pretested the instrument to ensure its usefulness, including attention to comprehension of the survey text. Thus the PI believes the survey has high practical utility for estimating urban values for the scenarios posed.
The PI believes it is preferable to have public input on the effluent management issues considered in the survey, by use of a carefully designed and pretested instrument, than for public input to not be available. The PI agrees that its intent is a scientifically rigorous study. The PI views the potential for management insight as a motivation for, rather than a detriment of, the study.
EPA Question 2 for commenters:
Evaluate 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.
Comment 2.1 from Tumacácori National Historical Park:
We have noted several inconstancies as described in the survey and the supporting statement (EPA-HQ-ORD-2013-0282-0002):
   * The estimate of the burden of the proposed collection does not include, or at least clearly indicate the development of the survey or the supporting documentation, the development of the notice to the Federal Register, or the time required by commenters to review these documents and develop comments.
   * The estimate of burden to the agency covers a period of 20 weeks from the start of mailing the survey, and does not include development of the survey, the analysis or writing the report, but the estimate includes only 8 weeks of labor by the principal investigator.
   * The methodology and the assumptions used to estimate the burden appear to misleadingly underestimate the actual burden.
Response to Comment 2.1 from Tumacácori National Historical Park:
The estimates are correct as listed. The burden calculation in the supporting statement (part 6) provides information on the cost and burden associated with the information collection for both the respondents and the agency. The survey timeline extends over a period of 20 weeks since there are time gaps while people receive and reply to the survey, not all of this time would actually be dedicated exclusively to the collection of the data.
The survey was developed in association with research outcomes from an initial round of focus groups, and then pretesting of the survey instrument using focus group and interview techniques. The public burden of these focus groups and interviews is not included in the supporting statement for the survey but was applied for and approved, under the separate ICR# 2090-0028. This is stated in the supporting statement section 5(a).
Comment 2.2 from Tumacácori National Historical Park:
   * The survey and comments do not sample representative populations that would be most affected by the proposed scenarios. Aside from the public register notice, no formal notice was provided to residents of Santa Cruz County, the location of the effluent-dominated upper Santa Cruz reach referenced in the survey, and none of the residents of this area are included in the survey. Very few comments have been received in response to the Federal Register notice, but a wider public awareness of this survey and the potential implications would without a doubt elicit many more comments on this controversial issue.
Response to Comment 2.2 from Tumacácori National Historical Park:
This point does not address an alternate methodology for calculating burden. The intention to sample urban populations is addressed in response to comment 1.6 above. The intention of the survey is precisely to broaden the knowledge of public opinion on the issues the survey considers.
Comment 2.3 from Tumacácori National Historical Park:
   * If one purpose of the study is indeed to assess the value that people place on rivers in the southwest (as communicated by the author), non-effluent dominated rivers should be included in the scenarios, such as the Verde, the Gila, and the Colorado, to name a few.
Response to Comment 2.3 from Tumacácori National Historical Park:
This point does not address an alternate methodology for calculating burden. As described in response to comment 1.4, the study is designed to be relevant to Santa Cruz River management, but there may be management insights on other similar contexts.
EPA Question 3 for commenters:
Enhance the quality, utility, and clarity of the information to be collected.
Comment 3.1 from Tumacácori National Historical Park:
The quality, utility and clarity could be enhanced by consideration of the following points:
   * Revise the survey significantly to include a balanced presentation of the outcomes of feasible alternatives.
Response to Comment 3.1 from Tumacácori National Historical Park:
This study, like any study, could have been designed differently and could have addressed additional questions. As designed it follows best scientific practice to address a limited set of meaningful questions and provide useful information on them.
Comment 3.2 from Tumacácori National Historical Park:
   * The quality of information would be enhanced by sampling rural as well as urban populations and by increasing the number of respondents from southern Arizona as contrasted with respondents from central Arizona.
Response to Comment 3.2 from Tumacácori National Historical Park:
EPA ORD has chosen a research design that emphasizes urban populations, a decision that was influenced by the disproportionate percentage (79% as described in response to comment 1.6 above) of the population of southern Arizona living in the urban areas to be sampled. The scope of the research is not meant to provide a complete accounting of effluent management options for all populations. Research in rural areas is not proposed by this research project. This is an important limitation to the study which will be noted in study reporting.
Comment 3.3 from Tumacácori National Historical Park:
   * The flow scenarios should be more explicit in regards to where and how the various reaches of each of the wetted and non-wetted river reaches would be impacted and should provide clarity on the complexity of the issues related to the questions being asked. The survey questions and project background do not sufficiently describe the impacts that would occur as a result of the changes in management of the Santa Cruz River proposed in the scenarios. If the public were informed of these potential impacts, such as loss of biodiversity, loss of riparian areas, and stress to wildlife species at risk, the response would be different than it would otherwise be without that background.
Response to Comment 3.3 from Tumacácori National Historical Park:
A key element of the survey is partnering research allowing for the characterization of current condition flow and forest conditions, and overall predictions of how forest extent (for both the North and South Santa Cruz River effluent-dominated reaches) would change with changes in extent of surface flow. These natural science predictions were made available by researchers at the University of Arizona and Arizona State University, as described in the consultations section of the supporting statement part 3(c). However these models are considered preliminary and are not highly spatially explicit. In terms of information provision, the survey is intentionally conservative in describing the management scenarios. The survey language is specific about the changes posed and only includes information to the extent specific changes can be modeled. The information included was extensively pretested and designed to focus on the key variables. Explanations of increased extinction risk or actual extinctions for certain species were not included. The PI agrees that this kind of information, if it was available and if it was included, would likely influence survey responses. It is well-known that information provided in the background of a willingness to pay survey influences results; the results of this survey would need to be interpreted and represented in the light of the information included.
Comment 3.4 from Tumacácori National Historical Park:
   * There should be citations listed on the survey for the natural system models referred to in the survey, and to other relevant documentation (e.g., groundwater-riparian vegetation interactions).
Response to Comment 3.4 from Tumacácori National Historical Park:
There were no requests from the pretest participants, drawn from diverse urban sociodemographics, to cite the basis for the natural science modeling in the survey background, although it would be appropriate to describe the methods and basis for other types of audiences. For example, the natural science models would be cited in the research report.
EPA Question 4 for commenters:
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.
Comment 4.1 from Tumacácori National Historical Park:
We do not feel that this survey would be an undue burden to respondents, and the estimates by the author in the supporting statement in regards to respondent burden are realistic.
Response to Comment 4.1 from Tumacácori National Historical Park:
The PI concurs.
Closing Comments from Tumacácori National Historical Park:
In conclusion, we feel that a survey to understand the value that people place in the Santa Cruz River would be a very useful tool. We also understand and laud the author's interest in conducting innovative and interesting research in social science within the region, and the likely usefulness of the results of this study to Tumacácori NHP. However, we feel that in the current form, the survey is flawed and will not yield useful results.
We strongly recommend that the authors consider a survey that does not obfuscate the intent or the issues for the sake of sample design or efficacy, and consider the population with the greatest interest in the resource. Thank you for providing this opportunity to comment.
Response to Closing Comments from Tumacácori National Historical Park:
The PI appreciates the chance to hear these comments from Tumacácori National Historical and greatly respects the work of the Park. The PI has responded to the detailed comments in the appropriate sections above. The careful sequence of pretesting and guidance from the best practices literature on willingness to pay survey instruments have been chronicled or reiterated from the supporting statement. The PI believes the survey rests on an extremely strong foundation. The project has an urban emphasis and this emphasis would be clearly stated in the research report. This is not meant to indicate that complementary research should not be pursued on rural values, nor meant to indicate that the variety of related potential research questions on effluent management are unimportant. The PI has not obfuscated intents or issues but has instead transparently proposed a survey to collect public opinion on public resource management questions.


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request EPA/ OECA/ CAMPD/ CMWPB 2. OMB control number b. G None a 2060  0289 3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c.

Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one)

a.

Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities: Will this information collection have a significant economic impact on a substantial number of small entities? G Yes

No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date:

a.

Three years from approval date b. G Other Specify: / /___

7. Title: Federal Standards for Marine Tank Vessel Loading Operations and National Emission Standards for Hazardous Air Pollutants for Marine Tank Vessel Loading Operations. ( 40 CFR Part 63, Subpart Y)

8. Agency form number( s) ( If applicable): 1679.04 9. Keywords: NESHAP, Marine Tank Vessel Loading Operations 10. Abstract: Respondents are owners or operators of marine tank vessel loading operations. Respondents must submit one time reports of initial performance tests and reports of non compliance. Record keeping of parameters related to the performance of air pollution control technologies is required. The reports and records will be used to demonstrate compliance with the standards.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 105 b. Total annual responses 105 1. Percentage of these responses collected electronically 0 % c. Total hours requested 28,131 d. Current OMB inventory 28,131 e. Difference 0 f. Explanation of difference 1. Program Change 2. Adjustment 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 2. Adjustment 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g . P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply)

a.

Recordkeeping b. Q Third party disclosure c.

Reporting 1.

On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biannually 8. Q Other ( describe) 17. Statistical methods Does this information collection employ statistical methods?

Q Yes

No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Virginia A. Lathrop Phone: ( 202) 564 7057 OMB 83 I 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Michael S. Alushin, Director Compliance Assessment and Media Programs Division Office of Compliance ( OECA) Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Regulatory Management and Evaluation ( OP) Date OMB 83 I Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

OMB 83 I ( Instructions) IMPORTANT NOTE TO USER:

This OMB form has been recreated in WP6.0 by OPPTS staff. The margins and lines are NOT block protected, so you must fill the form with caution, paying attention to any shifting of the existing text. The following tips should make this a simple task:

 Fill in the spaces by using the type over command. Otherwise you'll have to delete a space for each letter you add.

 Use the same font ( Times New Roman 8pt).

 Do not change table lines ( although you can delete an extra space line to provide more space elsewhere.

 It is not recommended that you convert this form to WP5.1, some of these features are not available in WP5.1, so the text will scramble.

If you have any problems or questions, please call your RID Desk Officer @ 260 2706.