[Federal Register: December 20, 2007 (Volume 72, Number 244)]
[Notices]
[Page 72353]
[DOCID:fr20de07-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 199-205]

South Carolina Public Service Authority; Santee Cooper
Hydroelectric Project; Notice of Proposed Restricted Service List for a
Programmatic Agreement for Managing Properties Included in or Eligible
for Inclusion in the National Register of Historic Places

December 13, 2007.
    Rule 2010 of the Federal Energy Regulatory Commission's
(Commission) Rules of Practice and Procedure provides that, to
eliminate unnecessary expense or improve administrative efficiency, the
Secretary may establish a restricted service list for a particular
phase or issue in a proceeding.\1\ The restricted service list should
contain the names of persons on the service list who, in the judgment
of the decisional authority establishing the list, are active
participants with respect to the phase or issue in the proceeding for
which the list is established.
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    \1\ 18 cfr 385.2010.
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    The Commission staff is consulting with the South Carolina State
Historic Preservation Officer (hereinafter, SHPO) and the Advisory
Council on Historic Preservation (hereinafter, Council) pursuant to the
Council's regulations, 36 CFR part 800, implementing Section 106 of the
National Historic Preservation Act, as amended, (16 U.S.C. 470f), to
prepare and execute a programmatic agreement for managing properties
included in, or eligible for inclusion in, the National Register of
Historic Places at Project No. 199.
    The programmatic agreement, when executed by the Commission and the
SHPO, would satisfy the Commission's Section 106 responsibilities for
all individual undertakings carried out in accordance with the license
until the license expires or is terminated (36 CFR 800.13[e]). The
Commission's responsibilities pursuant to Section 106 for the Santee
Cooper Hydroelectric Project would be fulfilled through the
programmatic agreement, which the Commission proposes to draft in
consultation with certain parties listed below. The executed
programmatic agreement would be incorporated into any Order issuing a
license.
    South Carolina Public Service Authority, as licensee for Project
No. 199, is invited to participate in consultations to develop the
Programmatic Agreement and to sign as a concurring party to the
Programmatic Agreement.
    For purposes of commenting on the Programmatic Agreement, we
propose to restrict the service list for Project No. 199-205 as
follows:

Dr. Laura Henley Dean, Advisory Council on Historic Preservation, The
Old Post Office Building, Suite 803, 1100 Pennsylvania Avenue, NW.,
Washington, DC 20004
Dr. Rodger E. Stroup, SHPO, or Representative, Department of Archives &
History, 8301 Parklane Road, Columbia, SC 29223-4905
Dr. James T. Kardatzke, Bureau of Indian Affairs, Eastern Regional
Office, 545 Marriott Drive, Suite 700, Nashville, TN 37214
Russell Townsend or Representative, Tribal Historic Preservation
Officer, Eastern Band of Cherokee Indians, Cultural Resources
Department, Qualla Boundary P.O. Box 455, Cherokee, NC 28719
Dr. Wenonah G. Haire, or Representative, Tribal Historic Preservation
Officer, Catawba Indian Nation, Catawba Cultural Preservation Project,
P.O. Box 750, Rock Hill, SC 29731
Charles D. Enyart, Chief, or Representative, Eastern Shawnee Tribe of
Oklahoma, P.O. Box 350, Seneca, MO 64804
Emman Spain or Representative, Tribal Historic Preservation Officer,
Seminole Nation of Oklahoma, P.O. Box 1498, Wewoka, OK 74884
John C. Dulude, P.E., Manager, FERC Relicensing, South Carolina Public
Service Authority, One Riverwood Drive, P.O. Box 2946101, Moncks
Corner, SC 29461-6101
Richard H. Kimmel, Archaeologist, Environmental Resources Section, US
Army Corps of Engineers, PO Box 1890, Wilmington, NC 28402
Amanda Hill, U.S. Fish & Wildlife Service, Charleston Field Office, 176
Croghan Spur Road, Suite 200, Charleston, SC 29407
Robert Morgan, Heritage Program Manager, Francis Marion & Sumter
National Forests, 2421 Witherbee Road, Cordesville, SC 29434

    Any person on the official service list for the above-captioned
proceedings may request inclusion on the restricted service list, or
may request that a restricted service list not be established, by
filing a motion to that effect within 15 days of this notice date.
    An original and 8 copies of any such motion must be filed with the
Secretary of the Commission (888 First Street, NE., Washington, DC
20426) and must be served on each person whose name appears on the
official service list.
    If no such motions are filed, the restricted service list will be
effective at the end of the 15 day period. Otherwise, a further notice
will be issued ruling on the motion.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-24664 Filed 12-19-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: August 13, 2008 (Volume 73, Number 157)]
[Rules and Regulations]
[Page 47027-47029]
[DOCID:fr13au08-1]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0584; Directorate Identifier 2007-NM-315-AD;
Amendment 39-15639; AD 2008-17-01]
RIN 2120-AA64

Airworthiness Directives; Dornier Model 328-100 Airplanes

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

ACTION: Final rule.

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

SUMMARY: The FAA is superseding an existing airworthiness directive
(AD), which applies to all AvCraft Dornier Model 328-100 airplanes.
That AD currently requires modifying the electrical wiring of the fuel
pumps; installing insulation at the hand flow control and shut-off
valves, and other components of the environmental control system; and
installing markings at fuel wiring harnesses. The existing AD also
requires revising the Airworthiness Limitations section of the
Instructions for Continued Airworthiness to incorporate new inspections
of the fuel tank system. This new AD replaces the flight-hour-based
threshold for conducting certain initial inspections, with an 8-year
threshold. This AD results from fuel system reviews conducted by the
manufacturer. We are issuing this AD to reduce the potential of
ignition sources inside fuel tanks, which, in combination with
flammable fuel vapors, could result in fuel tank explosions and
consequent loss of the airplane.

DATES: This AD becomes effective September 17, 2008.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of September 17,
2008.
    On July 29, 2005 (70 FR 36470, June 24, 2005), the Director of the
Federal Register approved the incorporation by reference of AvCraft
Service Bulletin SB-328-00-445, including Price Information Sheet,
dated August 23, 2004; and Dornier Temporary Revision ALD-080, dated
October 15, 2003.

ADDRESSES: For service information identified in this AD, contact 328
Support Services GmbH, P.O. Box 1252, D-82231 Wessling, Federal
Republic of Germany.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (telephone<PHONE_NUMBER>) is the Document Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Tom Groves, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1503; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to include an AD that supersedes AD 2005-13-24, amendment
39-14161 (70 FR 36470, June 24, 2005). The existing AD applies to all
AvCraft Dornier Model 328-100 airplanes. That NPRM was published in the
Federal Register on May 22, 2008 (73 FR 29720). That NPRM proposed to
continue to require modifying the electrical wiring of the fuel pumps;
installing insulation at the hand flow control and shut-off valves, and
other components of the environmental control system; and installing
markings at fuel wiring harnesses. That NPRM also proposed to continue
to require revising the Airworthiness Limitations section (ALS) of the
Instructions for Continued Airworthiness to incorporate new inspections
of the fuel tank system. That NPRM also proposed to replace the flight-
hour-based threshold for conducting certain initial inspections, with
an 8-year threshold.

Comments

    We provided the public the opportunity to participate in the
development of this AD. No comments have been received on the NPRM or
on the determination of the cost to the public.

Change to ``Later Revisions of the ALD'' Paragraph of the NPRM

    We removed all references to the use of ``later revisions'' of the
applicable service information from this AD to be consistent with FAA
policy. This change will not increase the economic burden on any
operator, nor will it increase the scope of the AD, since we may
consider approving the use of later revisions of the service bulletin
as an alternative method of compliance with this AD, as provided by
paragraph (j) of this AD.

Conclusion

    We have carefully reviewed the available data, and determined that
air safety and the public interest require adopting the AD with the
change described previously. We have determined that this change will
neither increase the economic burden on any operator nor increase the
scope of the AD.

Costs of Compliance

    This AD affects about 16 airplanes of U.S. registry. The actions
that are required by AD 2005-13-24 and retained in this AD take about
70 work hours per airplane, at an average labor rate of $80 per work
hour. Required parts cost about $14,118 per airplane. Based on these
figures, the estimated cost of the currently required actions is
$315,488, or $19,718 per airplane.
    The new required action to revise the ALS takes about 1 work hour
per airplane. Based on these figures, the estimated cost of the new
actions specified in this AD for U.S. operators is $1,280, or $80 per
airplane.

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.

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 this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under 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 a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket. See the ADDRESSES
section for a location to examine the regulatory evaluation.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 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. The Federal Aviation Administration (FAA) amends Sec.  39.13 by
removing amendment 39-14161 (70 FR 36470, June 24, 2005) and by adding
the following new airworthiness directive (AD):

2008-17-01 328 Support Services GmbH (Formerly Avcraft Aerospace
GmbH): Amendment 39-15639. Docket No. FAA-2008-0584; Directorate
Identifier 2007-NM-315-AD.

Effective Date

    (a) This AD becomes effective September 17, 2008.

Affected ADs

    (b) This AD supersedes AD 2005-13-24.

Applicability

    (c) This AD applies to all Dornier Model 328-100 airplanes,
certificated in any category.

Unsafe Condition

    (d) This AD results from fuel system reviews conducted by the
manufacturer. We are issuing this AD to reduce the potential of
ignition sources inside fuel tanks, which, in combination with
flammable fuel vapors, could result in fuel tank explosions and
consequent loss of the airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

    Note 1: This AD requires revisions to certain operator
maintenance documents to include inspections. Compliance with these
inspections is required by 14 CFR 91.403(c). For airplanes that have
been previously modified, altered, or repaired in the areas
addressed by these inspections, the operator may not be able to
accomplish the inspections described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance according
to paragraph (j) of this AD. The request should include a
description of changes to the required inspections that will ensure
the continued operational safety of the airplane.

Restatement of the Requirements of AD 2005-13-24

Modification and Installations

    (f) Within 12 months after the July 29, 2005 (the effective date
of AD 2005-13-24), do the actions in Table 1 of this AD in
accordance with the Accomplishment Instructions of AvCraft Service
Bulletin SB-328-00-445, dated August 23, 2004; or Revision 1, dated
June 17, 2005.

                          Table 1--Requirements
------------------------------------------------------------------------
                                             By accomplishing all the
       Do the following actions--             actions specified in--
------------------------------------------------------------------------
(1) Modify the electrical wiring of the   Paragraph 2.B(1) of the
 left-hand and right-hand fuel pumps.      service bulletin.
(2) Install insulation at the left-hand   Paragraph 2.B(2) of the
 and right-hand flow control and shut-     service bulletin.
 off valves, and other components of the
 environmental control system.
(3) Install markings at fuel wiring       Paragraph 2.B(3) of the
 harnesses.                                service bulletin.
------------------------------------------------------------------------

Revision to Airworthiness Limitations

    (g) Within 12 months after July 29, 2005, revise the
Airworthiness Limitations section of the Instructions for Continued
Airworthiness by inserting a copy of Dornier Temporary Revision ALD-
080, dated October 15, 2003, into the Dornier 328 Airworthiness
Limitations Document. Thereafter, except as provided in paragraphs
(i) and (j) of this AD, no alternative inspection intervals may be
approved for this fuel tank system.

New Requirements of This AD

Revised Initial Compliance Time

    (h) For Tasks 28-00-00-02 and 28-00-00-03 (``Detailed Inspection
of Outer Fuel Tank harness internal, LH/RH,'' and ``Detailed
Inspection of Inner Fuel Tank harness internal, LH/RH''), as
identified in Dornier Temporary Revision ALD-080, dated October 15,
2003, or Section F, ``Fuel Tank System Limitations,'' of the Dornier
328 Airworthiness Limitations Document (ALD), Revision 15, dated
January 15, 2005; the initial compliance time is within 8 years
after the effective date of this AD. Thereafter, except as provided
by paragraphs (i) and (j) of this AD, these tasks must be
accomplished at the repetitive interval specified in Section F,
``Fuel Tank System Limitations,'' of the Dornier 328 ALD, Revision
15, dated January 15, 2005.

No Alternative Inspections, Inspection Intervals, or CDCCLs

    (i) After accomplishing the actions specified in paragraphs (g)
and (h) of this AD, no alternative inspections, inspection
intervals, or CDCCLs may be used unless the inspections, intervals,
or CDCCLs are approved as an alternative method of compliance (AMOC)
in accordance with the procedures specified in paragraph (j) of this
AD.

Alternative Methods of Compliance (AMOCs)

    (j) The Manager, ANM-116, International Branch, Transport
Airplane Directorate, FAA, has the authority to approve AMOCs for
this

AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Tom Groves, Aerospace Engineer, International
Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind
Avenue, SW., Renton, Washington 98057-3356; telephone (425) 227-
1503; fax<PHONE_NUMBER>. Before using any approved AMOC on any
airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.

Related Information

    (k) EASA airworthiness directive 2006-0197 [Corrected], dated
July 11, 2006, also addresses the subject of this AD.

Material Incorporated by Reference

    (l) You must use the service information specified in Table 2 of
this AD to perform the actions that are required by this AD, unless
the AD specifies otherwise.

                                   Table 2--Material Incorporated by Reference
----------------------------------------------------------------------------------------------------------------
         Service information                       Revision level                            Date
----------------------------------------------------------------------------------------------------------------
AvCraft Service Bulletin SB-328-00-    Original.............................  August 23, 2004.
 445, including Price Information
 Sheet.
AvCraft Service Bulletin SB-328-00-    1....................................  June 17, 2005.
 445.
Dornier Temporary Revision ALD-080...  Original.............................  October 15, 2003.
Section F, ``Fuel Tank System          15...................................  January 15, 2005.
 Limitations,'' of Dornier 328
 Airworthiness Limitations Document.
----------------------------------------------------------------------------------------------------------------

    (1) The Director of the Federal Register approved the
incorporation by reference of AvCraft Service Bulletin SB-328-00-
445, Revision 1, dated June 17, 2005; and Section F, ``Fuel Tank
System Limitations,'' of Dornier 328 Airworthiness Limitations
Document, Revision 15, dated January 15, 2005; in accordance with 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) On July 29, 2005 (70 FR 36470, June 24, 2005), the Director
of the Federal Register approved the incorporation by reference of
AvCraft Service Bulletin SB-328-00-445, including Price Information
Sheet, dated August 23, 2004; and Dornier Temporary Revision ALD-
080, dated October 15, 2003.
    (3) Contact 328 Support Services GmbH, P.O. Box 1252, D-82231
Wessling, Federal Republic of Germany, for a copy of this service
information. You may review copies at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>, or
go to: http://www.archives.gov/federal-register/cfr/ibr-
locations.html.

    Issued in Renton, Washington, on July 29, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E8-18425 Filed 8-12-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 210 (Thursday, October 30, 2014)]
[Notices]
[Pages 64603-64604]
[FR Doc No: 2014-25800]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1497]

Toxicological Principles for the Safety Assessment of Food
Ingredients; Public Meeting on Updates and Safety and Risk Assessment
Considerations; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing a
public meeting to solicit comments on certain topics related to our
guidance titled ``Toxicological Principles for the Safety Assessment of
Food Ingredients,'' known less formally as the ``Redbook.'' The purpose
of our public meeting is to invite public input into possibly expanding
the scope of the Redbook to include chemical safety assessments for all
products over which FDA's Center for Food Safety and Applied Nutrition
(CFSAN) has statutory authority including regulatory contexts such as
food additives, food contact substances, dietary supplement
ingredients, food contaminants, and cosmetics. The Redbook would
describe toxicological principles which apply across regulatory
categories while still providing specific guidance for applying these
principles within each particular context. The safety of foods
containing microbial contaminants will continue to remain outside of
the scope of the Redbook.

DATES: See section III, ``How to Participate in the Public Meeting,''
in the SUPPLEMENTARY INFORMATION section of this document for the date
and time of the public meeting, closing dates for advance registration,
and information on deadlines for submitting either electronic or
written comments to FDA's Division of Dockets Management.

ADDRESSES: See section III, ``How To Participate in the Public
Meeting,'' in the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT:
    For questions about registering for the meeting; to register by
telephone; or to register by mail, FAX, or email: Courtney Treece,
Planning Professionals Ltd., 1210 W. McDermott St., Suite 111, Allen,
TX 75013,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    For general questions about the meeting or for special
accommodations due to a disability: Jeremiah Fasano, Center for Food
Safety and Applied Nutrition (HFS-255), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The guidance titled ``Toxicological Principles for the Safety
Assessment of Food Ingredients,'' or ``Redbook,'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ucm2006826.htm) provides guidance to
industry and other stakeholders (e.g., academia and other regulatory
groups) regarding the information used by CFSAN to evaluate the safety
of food and color additives. The Federal Food, Drug, and Cosmetic Act
(the FD&C Act) requires our premarket approval of the use of a new food
or color additive, including the new use of an approved additive. With
respect to premarket approval, the safety of food additives and color
additives used in foods must be established by evaluating the probable
exposure to the substance and appropriate toxicological and other
safety information. Thus, approval of any new food additive or color
additive used in foods depends, in part, upon the outcome of toxicity
tests that are performed and evaluated before marketing. The law also
allows a manufacturer to market a substance for a use without premarket
approval, if the substance is generally recognized as safe (GRAS).
However, general recognition of safety based upon scientific procedures
requires the same quantity and quality of evidence as is required to
obtain food additive approval (21 CFR 170.30(b)). The same
toxicological principles apply to other types of cosmetic and food
safety assessments, such as for contaminants and for dietary
ingredients in dietary supplements. However, the kind of information
needed varies depending on the product types based on the requirements
of the FD&C Act.
    The Redbook sets out a system of tiered recommendations for
additives in foods. These recommendations provide guidance on how much
toxicity testing should be done depending on the level of estimated
exposure to a substance in foods. The Redbook is a guidance document
that is intended to help interested parties understand FDA's
expectations regarding:
     Determining the human exposure that will occur from the
use of the ingredient in foods;
     Determining which toxicity studies are appropriate;
     Designing, conducting, and reporting the results of
toxicity studies; and
     Submitting the information to FDA as part of a safety
assessment.
    Subsequent to the Redbook's publication, we provided a related
guidance document titled ``Guidance for Industry: Preparation of Food
Contact Notifications for Food Contact Substances: Toxicology
Recommendations'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm081825.htm) describing the
information we expect in various types of submissions concerning the
safety of substances added to foods, such as food contact substances
(formerly known as indirect food additives), substances generally
recognized as safe for a defined use in foods, and new dietary
ingredients in dietary supplement products. This related guidance
document illustrates how the Redbook, developed for food additive and
color additive premarket reviews, can inform assessments in other
regulatory contexts, including risk assessments of constituent
residues.

II. Purpose and Scope of the Public Meeting:

    The purpose of this public meeting is to invite public comment on
what should be included, changed, or even excluded from the updated
Redbook. We are interested in expanding the scope of the Redbook to
emphasize the principles of safety and risk assessment that are shared
across different regulatory contexts for foods and cosmetics, while
still providing specific guidance for applying these principles in
particular contexts such as the requirements for pre-market safety
submissions or for risk assessments conducted on foods and cosmetics
already on the market. We invite comments from interested parties on
the following topics:
    1. What components of the Redbook should receive priority for
review and update?
    2. What aspects of the safety and risk assessment of food
ingredients or other CFSAN-regulated products are not addressed and
should be considered for incorporation in the Redbook?
    3. How can the Redbook be updated to more fully support the
development and submission of safety assessments for substances
introduced into food?

    4. How should we balance the desire for transparency and
consistency in risk assessment as described in the Redbook, with the
goal of flexibility in applying the most appropriate analysis for
specific contexts?

III. How To Participate in the Public Meeting

    We are holding the public meeting to invite public comment on what
should be included, changed, or even excluded from the updated Redbook.
Due to limited space and time, we encourage all persons who wish to
attend the meeting to register in advance. There is no fee to register
for the public meeting, and registration will be on a first-come,
first-served basis. Early registration is recommended because seating
is limited. Onsite registration will be accepted, as space permits,
after all preregistered attendees are seated. Live Webcasting of the
event is also being offered through the registration process.
    Those requesting an opportunity to make an oral presentation during
the time allotted for public comment at the meeting are asked to submit
a request. When submitting a request to make an oral presentation,
individuals should identify the number of each question they wish to
address (see II. Purpose and Scope of the Public Meeting) in their
presentation to help us organize the presentations. We would like to
maximize the number of individuals who make a presentation at the
meeting. If time permits, individuals or organizations that did not
register in advance may be granted the opportunity to make an oral
presentation.
    We encourage persons and groups who have similar interests to
consolidate their information for presentation by a single
representative. After reviewing the presentation requests, we will
notify each participant before the meeting of the approximate time
their presentation is scheduled to begin.
    While oral presentations from specific individuals and
organizations will be necessarily limited due to time constraints
during the public meeting, stakeholders may submit electronic or
written comments discussing any issues of concern to the administrative
record (the docket).
    Table 1 of this document provides information on participation in
the public meeting:
---------------------------------------------------------------------------

    \1\ You may also register via telephone, email, mail, or FAX.
Please include your name, title, firm name, address, and phone and
FAX numbers in your registration information and send to: Courtney
Treece, Planning Professionals Ltd., 1210 W. McDermott St., Suite
111, Allen, TX 75013,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>Onsite registration will also be
available.
    \2\ You may also request to make an oral presentation at the
public meeting via email. Please include your name, title, firm
name, address, and phone and FAX numbers and send to: Jeremiah
Fasano,, Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740,
240-402-1173, email<EMAIL_ADDRESS>
    Table 1--Information on Participation in the Meeting and on Submitting Comments to the Rulemaking Dockets
----------------------------------------------------------------------------------------------------------------
                                             Date              Electronic address               Address
----------------------------------------------------------------------------------------------------------------
Public meeting....................  December 9, 2014.....  http://www.fda.gov/Food/    Wiley Building, 5100
                                                            NewsEvents/                 Paint Branch Pkwy.,
                                                            WorkshopsMeetingsConferen   College Park, MD 20740.
                                                            ces/default.htm.
Advance registration..............  By December 2, 2014..  Individuals who wish to     We encourage you to use
                                                            participate in person are   electronic registration
                                                            asked to preregister at     if possible.\1\
                                                            http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
Request to make an oral             By November 21, 2014.  http://www.fda.gov/Food/
 presentation.                                              NewsEvents/
                                                            WorkshopsMeetingsConferen
                                                            ces/default.htm \2\.
Request special accommodations due  By November 21, 2014.  Jeremiah Fasano, email:     See FOR FURTHER
 to a disability<EMAIL_ADDRESS> INFORMATION CONTACT.
                                                            ov.
Submit electronic or written        By February 9, 2015..  Docket FDA-2014-N-1497....  Division of Dockets
 comments.                                                                              Management (HFA-305),
                                                                                Food and Drug
                                                                                Administration, 5630
                                                                                Fishers Lane, rm. 1061,
                                                                                Rockville, MD 20852.
----------------------------------------------------------------------------------------------------------------

IV. Request for Comments

    Regardless of attendance at the public meeting, interested persons
may submit either electronic comments 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. To ensure consideration, submit comments by February 9, 2015.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov.

V. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (see ADDRESSES). A transcript will
also be available in either hardcopy or on CD-ROM, after submission of
a Freedom of Information request. Written requests are to be sent to
the Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.

    Dated: October 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25800 Filed 10-29-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 74, Number 115 (Wednesday, June 17, 2009)]
[Rules and Regulations]
[Pages 28609-28612]
[FR Doc No: E9-14252]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-1119]
RIN 1625-AA11

Regulated Navigation Area; Chesapeake and Delaware Canal,
Chesapeake City Anchorage Basin, MD

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: The Coast Guard is establishing a permanent regulated
navigation area (RNA) in certain waters of the Chesapeake and Delaware
(C & D) Canal, within the anchorage basin at Chesapeake City, Maryland,
to be enforced annually, on the last Saturday in June, from 12:01 a.m.
until 11:59 p.m. This RNA is necessary to provide for the safety of
life, property and the environment. This RNA will restrict and control
the movement of vessels throughout the anchorage basin during the Town
of Chesapeake City's Canal Day event.

DATES: This rule is effective on June 17, 2009.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2008-1119 and are available online by going to
http://www.regulations.gov, selecting the Advanced Docket Search option
on the right side of the screen, inserting USCG-2008-1119 in the Docket
ID box, pressing Enter, and then clicking on the item in the Docket ID
column. This material is also available for inspection or copying at
the 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, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Mr. Ronald L. Houck, Sector Baltimore Waterways
Management Division, Coast Guard; telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On March 12, 2009, we published a notice of proposed rulemaking
(NPRM) entitled ``Regulated Navigation Area; Chesapeake and Delaware
Canal, Chesapeake City Anchorage Basin, MD'' in the Federal Register
(74 FR 10695). We received no comments on the proposed rule. No public
meeting was requested, and none was held.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to the public interest since immediate
action is needed to ensure the boating public's safety during the Canal
Day festivities taking place in June 2009. Congestion created by the
influx of boats and visitors for Canal Day festivities would
substantially raise the risk of accidental

drownings, personnel injuries, boat fires, boat capsizings and
sinkings, and boating collisions, and the congestion would make
response to such incidents much more difficult.

Background and Purpose

    Each year, on the last Saturday in June, thousands of people attend
the Town of Chesapeake City's Canal Day outdoor waterfront festival,
located adjacent to the C & D Canal anchorage basin at Chesapeake City,
Maryland. Due to the growing presence of visiting boaters in recent
years, the waterways surrounding this annual event have become
increasingly congested. This congestion substantially raises the risk
of accidental drownings, personnel injuries, boat fires, boat
capsizings and sinkings, and boating collisions, and the congestion
makes response to such incidents much more difficult.
    For example, on a typical weekend 10 to 15 boats anchor in the
basin, which is approximately 420 yards in length and 170 yards in
width. However, during Canal Day waterfront events, the number of boats
anchoring in and around the basin far exceeds this number. In 2007, an
estimated 400 boats and 10,000 visitors came to Chesapeake City, a town
with a population of 800. An estimated 325 recreational boats were
anchored or moored alongside other boats (rafted). These boats
accounted for approximately 600 visitors. Persons on recreational
vessels or other water craft began arriving on the Wednesday before the
festival, and by that evening, large lines of rafted boats filled the
anchorage basin, exceeding the safety limits two days before the event.
    The Coast Guard has the authority under 33 Code of Federal
Regulations part 165 to impose appropriate controls on activities that
may pose a threat to persons, vessels and facilities under its
jurisdiction. In June 2008, a Temporary Final Rule (33 CFR 165.T05-
0315; 73 FR 35588) was implemented and proved to be a beneficial tool
to ensure safety and to control vessel movement during this event.
Therefore, the Coast Guard is now establishing a permanent RNA that
will be enforced on the last Saturday in June, annually, in the C & D
Canal, within the anchorage basin at Chesapeake City, Maryland. The
rule will control vessel movement during this event, in order to
promote maritime safety, and to protect the environment and maritime
public from the potential hazards associated with a large gathering of
recreational vessels and other watercraft in a confined area.

Discussion of Comments and Changes

    The Coast Guard received no comments in response to the NPRM. No
public meeting was requested and none was held.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. Though the RNA will be in effect for an
entire day, commercial traffic in the C & D Canal anchorage basin is
limited, and vessels transiting the C & D Canal may proceed safely
around the RNA.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule will affect the following entities, some of which
might be small entities: The owners or operators of vessels intending
to transit or anchor in a portion of the C & D Canal anchorage basin at
Chesapeake City, Maryland, from 12:01 a.m. until 11:59 p.m. on the last
Saturday in June, annually. This RNA will not have a significant
economic impact on a substantial number of small entities for the
following reasons: Although this rule will be in effect for the entire
day and applies to the entire anchorage basin, commercial vessel
traffic in this area is limited and traffic would be allowed to pass
within the RNA with the permission of the District Commander or his or
her designated representative, vessels transiting the C & D Canal may
proceed safely around the RNA, and the Coast Guard will issue maritime
advisories widely available to users of the waterway before the
effective period.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to
assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for Federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
Federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive

Order 12630, Governmental Actions and Interference with
Constitutionally Protected Property Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g), of the Instruction. This rule involves certain regulations for
vessels navigating the waters of the Chesapeake and Delaware Canal and
fits within the category of paragraph 34(g) because it establishes a
regulated navigation area.
    An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

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

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.556 to read as follows:

Sec.  165.556  Regulated Navigation Area; Chesapeake and Delaware
Canal, Chesapeake City Anchorage Basin, MD.

    (a) Location. The following area is a regulated navigation area:
All waters of the Chesapeake and Delaware (C & D) Canal within the
anchorage basin at Chesapeake City, Maryland, bounded by a line drawn
across the entrance to the basin from position latitude
39[deg]31'39.6'' N, longitude 075[deg]48'36.5'' W, to position latitude
39[deg]31'40.6'' N, longitude 075[deg]48'43.3'' W. All coordinates
refer to NAD 1983.
    (b) Definitions. For the purposes of this section:
    District Commander means the Commander, Fifth Coast Guard District
or any Coast Guard commissioned, warrant, or petty officer who has been
authorized by the Commander, Fifth Coast Guard District, to act on his
or her behalf, or his or her designated representative.
    (c) Regulations. The general regulations governing regulated
navigation areas, found in 33 CFR 165.13, apply to the regulated
navigation area described in paragraph (a) of this section.
    (1) All vessels and persons are prohibited from entering and
accessing this regulated navigation area, except as authorized by the
District Commander or his or her designated representative.
    (2) Persons or vessels requiring entry into or passage within the
regulated navigation area must request authorization from the District
Commander or his or her designated representative, by telephone at
(410) 576-2693 or by marine band radio on VHF-FM Channel 16 (156.8
MHz), from 12:01 a.m. until 11:59 p.m. on the last Saturday in June,
annually. All Coast Guard vessels enforcing this regulated navigation
area can be contacted on marine band radio VHF-FM Channel 16 (156.8
MHz).
    (3) The operator of any vessel entering or located within this
regulated navigation area shall:
    (i) Travel at no-wake speed,
    (ii) Stop the vessel immediately upon being directed to do so by
any commissioned, warrant or petty officer on board a vessel displaying
a Coast Guard Ensign, and
    (iii) Proceed as directed by any commissioned, warrant or petty
officer on board a vessel displaying a Coast Guard Ensign.
    (4) All vessels and persons within this regulated navigation area
must comply with any additional instructions of the District Commander
or the designated representative.
    (d) Enforcement. The U.S. Coast Guard may be assisted in the patrol
and enforcement of the regulated navigation area by any Federal, State,
and local agencies.
    (e) Enforcement period. This section will be enforced from 12:01
a.m. until 11:59 p.m. on the last Saturday in June, annually.

    Dated: May 26, 2009.
Fred M. Rosa, Jr.,
Rear Admiral, U.S. Coast Guard Commander, Fifth Coast Guard District.
[FR Doc. E9-14252 Filed 6-16-09; 8:45 am]
BILLING CODE 4910-15-P


[Federal Register Volume 81, Number 183 (Wednesday, September 21, 2016)]
[Notices]
[Pages 64917-64920]
[FR Doc No: 2016-22710]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]

Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 045

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a publication containing modifications the Agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
Recognized Consensus Standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 045'' (Recognition List Number: 045), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.

DATES: Submit electronic or written comments concerning this document
at any time. These modifications to the list of recognized standards
are effective September 21, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact

information, or other information that identifies you in the body of
your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of
1997: Modifications to the List of Recognized Standards, Recognition
List Number: 045.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at http://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday. FDA will
consider any comments received in determining whether to amend the
current listing of modifications to the list of recognized standards,
Recognition List Number: 045.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of Recognition List Number: 045 is available on
the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI of
this document for electronic access to the searchable database for the
current list of FDA recognized consensus standards, including
Recognition List Number: 045 modifications and other standards related
information. Submit written requests for a single hard copy of the
document entitled ``Modifications to the List of Recognized Standards,
Recognition List Number: 045'' to Scott A. Colburn, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request, or fax your request to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-
6287<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act
of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended section
514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions or other requirements.
    In a document published in the Federal Register of February 25,
1998 (63 FR 9561), FDA announced the availability of a guidance
entitled ``Recognition and Use of Consensus Standards.'' The document
described how FDA would implement its standard recognition program and
provided the initial list of recognized standards.
    Modifications to the initial list of recognized standards, as
published in the Federal Register, can be accessed at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
    These documents describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains hypertext
markup language (HTML) and portable document format (PDF) versions of
the list of FDA Recognized Consensus Standards. Both versions are
publicly accessible at the Agency's Internet site. See section VI of
this document for electronic access information. Interested persons
should review the supplementary information sheet for the standard to
understand fully the extent to which FDA recognizes the standard.

II. Modifications to the List of Recognized Standards, Recognition List
Number: 045

    FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency will recognize for
use in premarket submissions and other requirements for devices. FDA
will incorporate these modifications in the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA will use
the term ``Recognition List Number: 045'' to identify these current
modifications.
    In table 1, FDA describes the following modifications: (1) The
withdrawal of standards and their replacement by others, if applicable;
(2) the correction of errors made by FDA in listing previously
recognized standards; and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
    In section III, FDA lists modifications the Agency is making that
involve the initial addition of standards not previously recognized by
FDA.

                           Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
                                          Replacement
          Old recognition No.             recognition        Title of standard \1\               Change
                                              No.
----------------------------------------------------------------------------------------------------------------
                             A. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-85..................................  ..............  IEC 60601-1-6 Edition 3.0 2010- Withdrawn. See Rec# 5-
                                                         01 Medical electrical           89.
                                                         equipment--Part 1-6: General
                                                         requirements for basic safety
                                                         and essential performance--
                                                         Collateral standard:
                                                         Usability.
5-86..................................  ..............  IEC 60601-1-8 Edition 2.0 2006- Withdrawn. See Rec# 5-
                                                         10 Medical electrical           76.
                                                         equipment--Part 1-8: General
                                                         requirements for basic safety
                                                         and essential performance--
                                                         Collateral standard: General
                                                         requirements, tests and
                                                         guidance for alarm systems in
                                                         medical electrical equipment
                                                         and medical electrical
                                                         systems.
5-106.................................           5-109  ISO 80369-3 First edition 2016- Withdrawn and replaced
                                                         07-01 Small-bore connectors     with newer version.
                                                         for liquids and gases in
                                                         healthcare applications--Part
                                                         3: Connectors for enteral
                                                         applications.
----------------------------------------------------------------------------------------------------------------
                    B. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
19-3..................................  ..............  IEC 60601-1-10 Edition 1.0      Withdrawn. See Rec# 19-
                                                         2007-11 Medical electrical      9.
                                                         equipment--Part 1-10: General
                                                         requirements for basic safety
                                                         and essential performance--
                                                         Collateral standard:
                                                         Requirements for the
                                                         development of physiologic
                                                         closed-loop controllers.
19-5..................................  ..............  AAMI/ANSI ES60601-1:2005/(R)    Withdrawn. See Rec# 19-
                                                         2012 and C1:2009/(R) 2012 and   4.
                                                         A2:2010/(R) 2012
                                                         (Consolidated text) Medical
                                                         electrical equipment--Part 1:
                                                         General requirements for
                                                         basic safety and essential
                                                         performance (IEC 60601-
                                                         1:2005, MOD).
----------------------------------------------------------------------------------------------------------------
                              C. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-362.................................           6-379  ISO 7864 Fourth edition 2016-   Withdrawn and replaced
                                                         08-01 Sterile hypodermic        with newer version.
                                                         needles for single use--
                                                         Requirements and test methods.
6-366.................................           6-380  ISO 9626 Second edition 2016-   Withdrawn and replaced
                                                         08-01 Stainless steel needle    with newer version.
                                                         tubing for the manufacture of
                                                         medical devices--Requirements
                                                         and test methods.
6-376.................................           6-381  ISO 6009 Fourth edition 2016-   Withdrawn and replaced
                                                         08-01 Hypodermic needles for    with a newer version.
                                                         single use--Colour coding for
                                                         identification.
6-378.................................           6-382  ISO 11608-7 First edition 2016- Withdrawn and replaced
                                                         08-01 Needle-based injection    with a newer version.
                                                         systems for medical use--
                                                         Requirements and test
                                                         methods--Part 7:
                                                         Accessibility for persons
                                                         with visual impairment.
----------------------------------------------------------------------------------------------------------------
                           D. Obstetrics-Gynecology (OB-GYN)/Gastroenterology/Urology
----------------------------------------------------------------------------------------------------------------
9-61..................................  ..............  IEC 60601-2-18 Edition 3.0      Combined with 4-187.
                                                         2009-08 Medical electrical
                                                         equipment--Part 2-18:
                                                         Particular requirements for
                                                         the basic safety and
                                                         essential performance of
                                                         endoscopic equipment.
----------------------------------------------------------------------------------------------------------------
                                                  E. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-51.................................  ..............  ISO 15004-2 First edition 2007- Transition period.
                                                         02-15 Ophthalmic Instruments--
                                                         Fundamental requirements and
                                                         test methods--Part 2: Light
                                                         hazard protection.
----------------------------------------------------------------------------------------------------------------
                                                  F. Radiology
----------------------------------------------------------------------------------------------------------------
12-208................................  ..............  IEC 60601-2-22 Third Edition    Withdrawn. See Rec# 12-
                                                         2007-05 Medical electrical      268.
                                                         equipment--Part 2-22:
                                                         Particular requirements for
                                                         basic safety and essential
                                                         performance of surgical,
                                                         cosmetic, therapeutic and
                                                         diagnostic laser equipment.
12-210................................  ..............  IEC 60601-1-3 Edition 2.0 2008- Withdrawn. See Rec# 12-
                                                         01 Medical electrical           269.
                                                         equipment--Part 1-3: General
                                                         requirements for basic safety
                                                         and essential performance--
                                                         Collateral standard:
                                                         Radiation protection in
                                                         diagnostic x-ray equipment.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations

III. Listing of New Entries

    In table 2, FDA provides the listing of new entries and consensus
standards added as modifications to the list of recognized standards
under Recognition List Number: 045.

        Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                          Reference No.
        Recognition No.          Title of standard \1\      and date
------------------------------------------------------------------------
         A. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
5-110.........................  Packaged-Products for   ISTA 3A 2008.
                                 Parcel Delivery
                                 System Shipment 70 kg
                                 (150 lb) or Less.
5-111.........................  Packaged-Products for   ISTA 3B 2012.
                                 Less-Than-Truckload
                                 (LTL) Shipment.
5-112.........................  Unitized Loads of Same  ISTA 3E 2009.
                                 Product.
------------------------------------------------------------------------
                      B. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-265.........................  Liquid Chromatography-  C62-A: 2014.
                                 Mass Spectrometry
                                 Methods; Approved
                                 Guideline.
7-266.........................  A Framework for Using   EP19 Second
                                 CLSI Documents to       Edition: 2015.
                                 Evaluate Clinical
                                 Laboratory
                                 Measurement
                                 Procedures.
------------------------------------------------------------------------
                              C. Ophthalmic
------------------------------------------------------------------------
10-101........................  Ophthalmic optics--     ISO 18189 First
                                 Contact lenses and      edition 2016-06-
                                 contact lens care       01.
                                 products--Cytotoxicit
                                 y testing of contact
                                 lenses in combination
                                 with lens care
                                 solution to evaluate
                                 lens/solution
                                 interactions.
10-102........................  American National       ANSI Z80.36--
                                 Standard for            2016.
                                 Ophthalmics--Light
                                 Hazard Protection for
                                 Ophthalmic
                                 Instruments.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.

IV. List of Recognized Standards

    FDA maintains the Agency's current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed directly at
FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications
and revisions described in this notice into the database and, upon
publication in the Federal Register, this recognition of consensus
standards will be effective. FDA will announce additional modifications
and revisions to the list of recognized consensus standards, as needed,
in the Federal Register once a year, or more often if necessary.
Beginning with Recognition List 033, FDA no longer announces minor
revisions to the list of recognized consensus standards such as
technical contact person, devices affected, processes affected, Code of
Federal Regulations citations, and product codes.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for
recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation, to
<EMAIL_ADDRESS>To be properly considered, such recommendations
should contain, at a minimum, the following information: (1) Title of
the standard, (2) any reference number and date, (3) name and address
of the national or international standards development organization,
(4) a proposed list of devices for which a declaration of conformity to
this standard should routinely apply, and (5) a brief identification of
the testing or performance or other characteristics of the device(s)
that would be addressed by a declaration of conformity.

VI. Electronic Access

    You may obtain a copy of ``Guidance on the Recognition and Use of
Consensus Standards'' by using the Internet. The Center for Devices and
Radiological Health (CDRH) maintains a site on the Internet for easy
access to information including text, graphics, and files that you may
download to a personal computer with access to the Internet. Updated on
a regular basis, the CDRH home page, http://www.fda.gov/MedicalDevices,
includes a link to standards-related documents including the guidance
and the current list of recognized standards. After publication in the
Federal Register, this notice announcing ``Modification to the List of
Recognized Standards, Recognition List Number: 045'' will be available
at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. You may access ``Guidance on the Recognition
and Use of Consensus Standards,'' and the searchable database for ``FDA
Recognized Consensus Standards'' at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.

    Dated: September 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22710 Filed 9-20-16; 8:45 am]
 BILLING CODE 4164-01-P


- Forwarded by Erika Sasser/RTP/USEPA/US on 09/21/2006 06:49 PM -----

"Flynn, Amy E."<EMAIL_ADDRESS> 09/21/2006 04:31 PM

To

Erika Sasser/RTP/USEPA/US@EPA

cc

Subject

RE:

Got it.  Thank you for the update.

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Thursday, September 21, 2006 3:01 PM

To: Flynn, Amy E.

Cc<EMAIL_ADDRESS> Subject:

Amy--

We wanted you to know that we accepted almost all of Gok's comments,

including ones on p. 93 (typo), p. 97 (changed phrasing to match

preamble), p. 104 (changed to "numerous" to match preamble), p. 110

(changed to match preamble).

Only 2 we didn't take:        p. 105-- here "fundamentally flawed" is

usage from preamble

                  p. 166-- reference to prescribed fires-- we want to

stay away from commenting on fire issues becuase this is a BIG topic for

exceptional events rule and we want to let that rule speak to these

issues/examples.

Working to sync up other passges in RTC with final preamble as well.

We are also taking Cecelia's comments-- all 4 of them.

Erika


[Federal Register Volume 85, Number 193 (Monday, October 5, 2020)]
[Notices]
[Pages 62723-62724]
[FR Doc No: 2020-21949]

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

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: EC20-105-000.
    Applicants: Arlington Valley Solar Energy II, LLC, Centinela Solar
Energy, LLC.
    Description: Joint Application for Approval under Section 203 of
the Federal Power Act, et al. of Arlington Valley Solar Energy II, LLC,
et al.
    Filed Date: 9/28/20.
    Accession Number: 20200928-5159.
    Comments Due: 5 p.m. ET 10/19/20.

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

    Docket Numbers: EG20-250-000.
    Applicants: Topaz Generating, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Topaz Generating, LLC.
    Filed Date: 9/28/20.
    Accession Number: 20200928-5137.
    Comments Due: 5 p.m. ET 10/19/20.

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

    Docket Numbers: ER20-67-001; ER20-116-001; ER20-113-001.
    Applicants: Evergy Metro, Inc., Evergy Missouri West, Inc., Evergy
Kansas Central, Inc.
    Description: Notice of Change in Status of the Evergy MBR Sellers
under ER20-67, et al.
    Filed Date: 9/28/20.
    Accession Number: 20200928-5172.
    Comments Due: 5 p.m. ET 10/19/20.

    Docket Numbers: ER20-1890-001.
    Applicants: California Independent System Operator Corporation.
    Description: Compliance filing: 2020-09-29 Limited Time Waiver
Petition--Postpone Effect. Date to Jan. 1, 2021 to be effective N/A.
    Filed Date: 9/29/20.
    Accession Number: 20200929-5124.
    Comments Due: 5 p.m. ET 10/20/20.

    Docket Numbers: ER20-1890-002.
    Applicants: California Independent System Operator Corporation.

    Description: Compliance filing: 2020-09-29 Intertie Deviation
Settlement Compliance Filing to be effective 1/1/2021.
    Filed Date: 9/29/20.
    Accession Number: 20200929-5131.
    Comments Due: 5 p.m. ET 10/20/20.

    Docket Numbers: ER20-2550-002.
    Applicants: Entergy Mississippi, LLC.
    Description: Tariff Amendment: EML Choctaw Reactive Amendment to be
effective 10/1/2020.
    Filed Date: 9/29/20.
    Accession Number: 20200929-5132.
    Comments Due: 5 p.m. ET 10/20/20.

    Docket Numbers: ER20-2588-001.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Amendment: Errata to correct metadata in ER20-
2588-000 re: Cancellation of SA No. 4820 to be effective 6/30/2020.
    Filed Date: 9/29/20.
    Accession Number: 20200929-5038.
    Comments Due: 5 p.m. ET 10/20/20.

    Docket Numbers: ER20-3013-000.
    Applicants: Public Service Company of Colorado.
    Description: Tariff Cancellation: 2020-09-28_PSC-Big Horn-PLGIA-
572-0.1.0-NOC to be effective 9/29/2020.
    Filed Date: 9/28/20.
    Accession Number: 20200928-5132.
    Comments Due: 5 p.m. ET 10/19/20.

    Docket Numbers: ER20-3014-000.
    Applicants: Delmarva Power & Light Company, PJM Interconnection,
L.L.C.
    Description: Compliance filing: Delmarva Power & Light Company
submits Compliance Filing re: ER09-1158 to be effective N/A.
    Filed Date: 9/28/20.
    Accession Number: 20200928-5139.
    Comments Due: 5 p.m. ET 10/19/20.

    Docket Numbers: ER20-3015-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Revised ISA, Service
Agreement No. 1503; Queue No. AD2-001 to be effective 8/31/2020.
    Filed Date: 9/29/20.
    Accession Number: 20200929-5045.
    Comments Due: 5 p.m. ET 10/20/20.

    Docket Numbers: ER20-3016-000.
    Applicants: Dominion Energy South Carolina, Inc.
    Description: Sec.  205(d) Rate Filing: SCPSA Interconnection Agr
Amendment to be effective 11/30/2020.
    Filed Date: 9/29/20.
    Accession Number: 20200929-5056.
    Comments Due: 5 p.m. ET 10/20/20.

    Docket Numbers: ER20-3017-000.
    Applicants: Sierra Pacific Power Company.
    Description: Sec.  205(d) Rate Filing: Rate Schedule No. 55 SPPC &
Liberty 3rd Amended Service Agr to be effective 12/30/2020.
    Filed Date: 9/29/20.
    Accession Number: 20200929-5061.
    Comments Due: 5 p.m. ET 10/20/20.

    Docket Numbers: ER20-3018-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original WMPA, Service
Agreement No. 5803; Queue No. AF2-270 to be effective 9/8/2020.
    Filed Date: 9/29/20.
    Accession Number: 20200929-5065.
    Comments Due: 5 p.m. ET 10/20/20.

    Docket Numbers: ER20-3019-000.
    Applicants: Nevada Power Company.
    Description: Sec.  205(d) Rate Filing: Service Agreement No. 15-
00086 NPC NITSA to be effective 12/30/2020.
    Filed Date: 9/29/20.
    Accession Number: 20200929-5071.
    Comments Due: 5 p.m. ET 10/20/20.

    Docket Numbers: ER20-3020-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Cancellation: Notice of Cancellation of ISA,
Service Agreement No. 4781; Queue No. AB1-082 to be effective 9/18/
2020.
    Filed Date: 9/29/20.
    Accession Number: 20200929-5082.
    Comments Due: 5 p.m. ET 10/20/20.

    Docket Numbers: ER20-3021-000.
    Applicants: New York Independent System Operator, Inc., New York
State Electric & Gas Corporation.
    Description: Sec.  205(d) Rate Filing: Joint NYISO & NYSEG 205 re:
SGIA (SA 2553) between NYISO, NYSEG and Janis Solar to be effective 9/
15/2020.
    Filed Date: 9/29/20.
    Accession Number: 20200929-5083.
    Comments Due: 5 p.m. ET 10/20/20.

    Docket Numbers: ER20-3022-000.
    Applicants: Public Service Company of Colorado.
    Description: Tariff Cancellation: 2020-09-29_PSC-Big Horn-E&P-557-
0.1.0-NOC to be effective 9/30/2020.
    Filed Date: 9/29/20.
    Accession Number: 20200929-5087.
    Comments Due: 5 p.m. ET 10/20/20.

    Docket Numbers: ER20-3023-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original WMPA, Service
Agreement No. 5809; Queue No. AF2-273 to be effective 9/10/2020.
    Filed Date: 9/29/20.
    Accession Number: 20200929-5093.
    Comments Due: 5 p.m. ET 10/20/20.

    Docket Numbers: ER20-3024-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to ISA, Service
Agreement No. 5631; Queue No. AC1-098/AC1-099 to be effective 3/19/
2020.
    Filed Date: 9/29/20.
    Accession Number: 20200929-5130.
    Comments Due: 5 p.m. ET 10/20/20.

    Docket Numbers: ER20-3025-000.
    Applicants: GridLiance High Plains LLC.
    Description: Sec.  205(d) Rate Filing: Gridliance HP Revisions to
Attachment K to be effective 11/29/2020.
    Filed Date: 9/29/20.
    Accession Number: 20200929-5133.
    Comments Due: 5 p.m. ET 10/20/20.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by 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: September 29, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-21949 Filed 10-2-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)]
[Notices]
[Pages 57804-57805]
[FR Doc No: 2015-24375]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CD15-33-000]

City of Cheyenne, Wyoming; Notice of Preliminary Determination of
a Qualifying Conduit Hydropower Facility and Soliciting Comments and
Motions To Intervene

    On August 26, 2015, the City of Cheyenne, Wyoming, by and through
its Board of Public Utilities, filed a notice of intent to construct a
qualifying conduit hydropower facility, pursuant to section 30 of the
Federal Power Act (FPA), as amended by section 4 of the Hydropower
Regulatory Efficiency Act of 2013 (HREA). The proposed Sherard
Hydroelectric Generation Facility would have an installed capacity of
950 kilowatts (kW), and would be located along an existing 48-inch-
diameter raw water pipeline within the city's water treatment plant.
The project would be located near the City of Cheyenne, Wyoming.
    Applicant Contact: Tim Wilson, Director, 2416 Snyder Ave.,
Cheyenne, WY 82001, Phone No.<PHONE_NUMBER>.
    FERC Contact: Christopher Chaney, Phone No.<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Qualifying Conduit Hydropower Facility Description: The proposed
project would consist of: (1) A proposed two-level powerhouse
approximately 36 feet by 36 feet adjacent to the existing water
treatment plant building; (2) an approximately 800-foot-long, up to 48-
inch-diameter penstock teeing off the existing 48-inch-diameter raw
water pipeline; (3) one impulse turbine/generator unit with an
installed capacity of 950 kilowatt (kW); (4) a short discharge
returning water to the existing 48-inch-diameter raw water pipeline;
and (5) appurtenant facilities.
    The proposed project would have a total installed capacity of 950
kW.
    A qualifying conduit hydropower facility is one that is determined
or deemed to meet all of the criteria shown in the table below.

      Table 1--Criteria for Qualifying Conduit Hydropower Facility
------------------------------------------------------------------------
                                                              Satisfies
     Statutory provision                Description             (Y/N)
------------------------------------------------------------------------
FPA 30(a)(3)(A), as amended    The conduit the facility      Y
 by HREA.                       uses is a tunnel, canal,
                                pipeline, aqueduct, flume,
                                ditch, or similar manmade
                                water conveyance that is
                                operated for the
                                distribution of water for
                                agricultural, municipal, or
                                industrial consumption and
                                not primarily for the
                                generation of electricity.
FPA 30(a)(3)(C)(i), as         The facility is constructed,  Y
 amended by HREA.               operated, or maintained for
                                the generation of electric
                                power and uses for such
                                generation only the
                                hydroelectric potential of
                                a non-federally owned
                                conduit.
FPA 30(a)(3)(C)(ii), as        The facility has an           Y
 amended by HREA.               installed capacity that
                                does not exceed 5 megawatts.
FPA 30(a)(3)(C)(iii), as       On or before August 9, 2013,  Y
 amended by HREA.               the facility is not
                                licensed, or exempted from
                                the licensing requirements
                                of Part I of the FPA.
------------------------------------------------------------------------

    Preliminary Determination: Based upon the above criteria,
Commission staff preliminarily determines that the proposal satisfies
the requirements for a qualifying conduit hydropower facility, which is
not required to be licensed or exempted from licensing.
    Comments and Motions to Intervene: Deadline for filing comments
contesting whether the facility meets the qualifying criteria is 45
days from the issuance date of this notice.
    Deadline for filing motions to intervene is 30 days from the
issuance date of this notice.
    Anyone may submit comments or a motion to intervene in accordance
with the requirements of Rules of Practice and Procedure, 18 CFR
385.210 and 385.214. Any motions to intervene must be received on or
before the specified deadline date for the particular proceeding.
    Filing and Service of Responsive Documents: All filings must (1)
bear in all capital letters the ``COMMENTS CONTESTING QUALIFICATION FOR
A CONDUIT HYDROPOWER FACILITY'' or ``MOTION TO INTERVENE,'' as
applicable; (2) state in the heading the name of the applicant and the
project number of the application to which the filing responds; (3)
state the name, address, and telephone number of the person filing; and
(4) otherwise comply with the requirements of sections 385.2001 through
385.2005 of the Commission's regulations.\1\ All comments contesting
Commission staff's preliminary determination that the facility meets
the qualifying criteria must set forth their evidentiary basis.
---------------------------------------------------------------------------

    \1\ 18 CFR 385.2001-2005 (2015).
---------------------------------------------------------------------------

    The Commission strongly encourages electronic filing. Please file
motions to intervene and comments using the Commission's eFiling system
at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. A copy of all other filings in
reference to this application must be accompanied by proof of service
on all persons listed in the service list prepared by the Commission in
this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
    Locations of Notice of Intent: Copies of the notice of intent can
be obtained directly from the applicant or such copies can be viewed
and reproduced at the Commission in its Public Reference Room, Room 2A,
888 First Street NE., Washington, DC 20426. The filing may also be
viewed on the Web at http://www.ferc.gov/docs-filing/elibrary.asp using
the ``eLibrary'' link. Enter the docket number (i.e., CD15-33) in the
docket number field to access the document. For assistance, call toll-
free 1-866-208-3676 or email<EMAIL_ADDRESS>For TTY, call
(202) 502-8659.

    Dated: September 3, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-24375 Filed 9-24-15; 8:45 am]
 BILLING CODE 6717-01-P