[Federal Register Volume 82, Number 177 (Thursday, September 14, 2017)]
[Notices]
[Pages 43243-43244]
[FR Doc No: 2017-19492]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0594]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Focus Groups as Used
by the Food and Drug Administration (All Food and Drug Administration-
Regulated Products)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by October
16, 2017.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0497.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance. Focus Groups as Used by the Food and Drug
Administration (All FDA-Regulated Products), OMB Control Number 0910-
0497.
    FDA conducts voluntary focus group interviews on a variety of
topics involving FDA-regulated products, including drugs, biologics,
devices, food, tobacco, and veterinary medicine.
    Focus groups provide an important role in gathering information
because they allow for a more in-depth understanding of patients' and
consumers' attitudes, beliefs, motivations, and feelings than do
quantitative studies. Focus groups serve the narrowly defined need for
direct and informal opinion on a specific topic and as a qualitative
research tool have three major purposes:
     To obtain patient and consumer information that is useful
for developing variables and measures for quantitative studies,
     To better understand patients' and consumers' attitudes
and emotions in response to topics and concepts, and
     To further explore findings obtained from quantitative
studies.
    FDA will use focus group findings to test and refine their ideas,
but will generally conduct further research before making important
decisions such as adopting new policies and allocating or redirecting
significant resources to support these policies.
    In the Federal Register of April 21, 2017 (82 FR 18763), FDA
published a 60-day notice requesting public comment on the proposed
collection of

information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Annual
                              Activity                                  Number of      frequency per     Total annual      Hours per       Total hours
                                                                       respondents        response        responses         response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Focus Group Interviews.............................................           8,800                1            8,800             1.75           15,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: September 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-19492 Filed 9-13-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: January 28, 2008 (Volume 73, Number 18)]
[Notices]
[Page 4942-4943]
[DOCID:fr28ja08-132]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Fifth Meeting: RTCA Special Committee 210, Cabin Systems and
Equipment

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of RTCA Special Committee 210, Cabin Management System.

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SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of RTCA Special Committee 210, Cabin Management.

DATES: The meeting will be held January 29-31, 2008, from 9 a.m.-5 p.m.

ADDRESSES: The meeting will be held at RTCA, Inc., 1828 L Street, NW.,
Suite 805, Washington, DC 20036, ARINC, Colson & Garmin Rooms.

FOR FURTHER INFORMATION CONTACT: (1) RTCA Secretariat, 1828 L Street,
NW., Suite 805, Washington, DC 20036; telephone<PHONE_NUMBER>; fax
(202) 833-9434; Web site http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C. appendix 2), notice is
hereby given for a Special Committee 210, Cabin Management Systems
meeting. The agenda will include:
     January 29:
     Opening Plenary Session (Welcome, Introductions, and
Administrative Remarks)
     Approval of Summary of the Fourth meeting held October 23-
25, 2007. RTCA Paper No. 285-07/SC210-009 (Chair)
     PMC update (RTCA)
     Regulatory Update (Regulatory Agency):
     FAA
     Transport Canada
     EUROCAE/ICAO
     Reports from Working Groups (WG Chairs)
     Current status (accomplishments since last plenary)--
Expect WG-3 to be complete and members to join WG-2
     Objectives for this plenary
     Review of WG Project Schedule
     Overall direction for Working Group (Chair)
     Organizational Items; leadership, WG structure, etc.
     Review of Committee Project Schedule
     Close Plenary Meeting
     Break-up for Specific Working Group Sessions
     Working Group 2, Cabin Management Function Classification
     Close out of day's activities
     Item for group discussion/resolution
     Review of tomorrow's activities
     January 30:
     Continue Specific Working Group Session
     Working Group 2, Cabin Management Function Classification
     Closeout of day's activities
     Items for group discussion/resolution
     Review of tomorrow's activities
     January 31:
     Continue Specific Working Group Sessions
     Working Group 2, Cabin Management Function Classification
     Convene to Continue Plenary Meeting
     Reports from Working Group Chairs
     Current status (accomplishments during plenary)
     Discussion/Resolution of outstanding issues
     Anticipated accomplishments by next plenary and plan to
achieve
     Other Committee Business
     Discussion of documents creation and text writing
assignments
     Document Structure/Review (Editor and Leadership Team)
     Review of Committee Project Schedule
     Terms of Reference--Review Status
     Assignment of Responsibilities
     Closing Plenary Session (Other Business, Establish Agenda
for Next

Meeting, Date, and Place of Next Meeting, Adjourn)
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairmen, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on January 16, 2008.
Francisco Estrada C.,
RTCA Advisory Committee.
[FR Doc. 08-320 Filed 1-25-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 78, Number 100 (Thursday, May 23, 2013)]
[Proposed Rules]
[Pages 30793-30795]
[FR Doc No: 2013-12309]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0446; Directorate Identifier 2010-SW-007-AD]
RIN 2120-AA64

Airworthiness Directives; Eurocopter Deutschland GmbH Model
Helicopters

AGENCY: Federal Aviation Administration (FAA) DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Eurocopter Deutschland GmbH (Eurocopter) Model EC135 P1, P2, P2+, T1,
T2, and T2+ helicopters to require inspecting each linear transducer
bearing (bearing) for freedom of movement. This proposed AD would also
require replacing the bearing if there is binding or rough turning or
if there is chafing or damage on the lower side of the floor. Also,
this proposed AD would require modifying and re-identifying a certain
rod. This proposed AD is prompted by an incident involving limited
control of a tail rotor because of the binding of a bearing. The
proposed actions are intended to detect and replace each bearing
subject to binding, which could lead to subsequent loss of control of
the helicopter.

DATES: We must receive comments on this proposed AD by July 22, 2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the economic
evaluation, any comments

received, and other information. The street address for the Docket
Operations Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.
    For service information identified in this proposed AD, contact
American Eurocopter Corporation, 2701 N. Forum Drive, Grand Prairie, TX
75052, telephone<PHONE_NUMBER> or<PHONE_NUMBER>, fax<PHONE_NUMBER>,
or at http://www.eurocopter.com/techpub. You may review the referenced
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas
76137.

FOR FURTHER INFORMATION CONTACT: Matt Fuller, Senior Aviation Safety
Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 2601
Meacham Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
No. 2006-0318 R1, dated October 27, 2006, to correct an unsafe
condition for all Eurocopter Model EC 135 helicopters. EASA advises of
an incident in which impaired control of an EC 135 tail rotor was
detected. EASA states that according to examinations, the bearing of
the linear transducer was subject to binding, which limited the control
range.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Germany and are approved for operation in the United States. Pursuant
to our bilateral agreement with Germany, EASA, its technical
representative, has notified us of the unsafe condition described in
its AD. We are proposing this AD because we evaluated all known
relevant information and determined that an unsafe condition exists and
is likely to exist or develop on other helicopters of these same type
designs.

Related Service Information

    Eurocopter has issued Alert Service Bulletin EC135-67A-012,
Revision 1, dated October 18, 2006 (ASB), which specifies inspecting
the bearing of the linear transducer for freedom of movement and the
lower side of the floor for chafing or damage. If there is binding, the
ASB specifies replacing the bearing. If there is chafing or damage on
the floor, the ASB specifies replacing the bearing and repairing the
floor. The ASB also specifies modifying and reidentifying a certain
rod. EASA classified this ASB as mandatory and issued EASA AD 2006-0318
R1, dated October 27, 2006, to ensure the continued airworthiness of
these helicopters.

Proposed AD Requirements

    This proposed AD would require, at specified intervals, inspecting
each bearing for freedom of movement. If there is binding or rough
turning, this proposed AD would require, before further flight,
replacing the bearing or if there is chafing or damage on the lower
side of the floor, replacing the bearing and repairing the floor, and,
thereafter, installing a Teflon strip. This proposed AD would also
require modifying the rod and re-identifying the rod and lever with a
new part number.

Differences Between This Proposed AD and the EASA AD

    This proposed AD does not refer to the compliance date of October
31, 2006, because that date has passed; instead we propose compliance
within 100 hours TIS. The proposed AD would not require contacting
Eurocopter customer support. This proposed AD would require modifying
each rod within 100 hours TIS, rather than within 800 hours TIS as
specified in the EASA AD.

Costs of Compliance

    We estimate that this proposed AD would affect 214 helicopters of
U.S. Registry. We estimate that operators may incur the following costs
in order to comply with this AD: It would take about 10 work-hours to
inspect the bearing for freedom of movement at an average labor rate of
$85 per work hour. No parts or materials are required for the
inspection. Based on these estimates, the cost would be $850 per
helicopter or $181,900 for the fleet of all U.S.-registered
helicopters. If necessary, replacing the bearing would require 3
additional work-hours, and parts would cost $50. Repairing the floor
would require 3 additional work hours and minimal cost for materials.

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 determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and

    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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 FAA amends Sec.  39.13 by adding the following new Airworthiness
Directive (AD):

Eurocopter Deutschland GmbH: Docket No. FAA-2013-0446; Directorate
Identifier 2010-SW-007-AD.

(a) Applicability

    This AD applies to Model EC135 P1, P2, P2+, T1, T2, and T2+
helicopters, with bearing, part number (P/N) LN9367GE6N2; rod, P/N
L671M5040205; lever, P/N L671M5040101; and floor, P/N L533M1014101,
L533M1014102, L533M1014103, L533M1014104, L533M1014105 or
L533M1014106, installed, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as limited control of a
tail rotor because of the binding of a bearing. This condition could
result in subsequent loss of control of the helicopter.

(c) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(d) Required Actions

    (1) Within 100 hours time-in-service (TIS) and thereafter at
intervals not to exceed 800 hours TIS, inspect each bearing for
freedom of movement by turning and tilting the bearing as depicted
in Figure 2 of Eurocopter Alert Service Bulletin No. EC135-67A-012,
Revision 1, dated October 18, 2006 (ASB). During any inspection:
    (i) If there is binding or rough turning, before further flight,
replace the bearing with an airworthy bearing.
    (ii) If there is chafing on the lower side of the floor that
does not extend through the panel outer layer, before further
flight, replace the bearing with an airworthy bearing.
    (iii) If there is damage on the lower side of the floor in the
area of the assembly opening that extends through the panel outer
layer (revealing an open honeycomb cell or layer), before further
flight, replace the bearing with an airworthy bearing and repair the
floor.
    (2) After performing the actions in (d)(1)(i) through (iii) of
this AD, before further flight, install a Teflon strip and identify
the floor by following the Accomplishment Instructions, paragraphs
3.E.(1) through 3.E.(4), of the ASB.
    (3) Within 100 hours TIS, modify and re-identify the rod as
depicted in Figure 1 of the ASB and by following the Accomplishment
Instructions, paragraphs 3.H.(1) through 3.H.(3)(f), of the ASB.

(e) Alternative Methods of Compliance (AMOC)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Matt Fuller, Senior Aviation
Safety Engineer, Safety Management Group, Rotorcraft Directorate,
FAA, 2601 Meacham Blvd., Fort Worth, Texas 76137; telephone (817)
222-5110; email<EMAIL_ADDRESS>    (2) For operations conducted under 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(f) Additional Information

    (1) For service information identified in this AD, contact
American Eurocopter Corporation, 2701 N. Forum Drive, Grand Prairie,
TX 75052, telephone<PHONE_NUMBER> or<PHONE_NUMBER>, fax (972) 641-
3775, or at http://www.eurocopter.com/techpub. You may review copies
of the service information at the FAA, Office of the Regional
Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth,
Texas 76137.
    (2) The subject of this AD is addressed in European Aviation
Safety Agency AD No. 2006-0318 R1, dated October 27, 2006.

(g) Subject

    The Joint Aircraft System/Component (JASC) Code is 6720: Tail
Rotor Control System.

    Issued In Fort Worth, Texas, on May 14, 2013.
Kim Smith,
Directorate Manager, Rotorcraft Directorate, Aircraft Certification
Service.
[FR Doc. 2013-12309 Filed 5-22-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: July 27, 2010 (Volume 75, Number 143)]
[Rules and Regulations]
[Page 43813-43814]
[DOCID:fr27jy10-6]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0241; Airspace Docket No. 10-AGL-4]
RIN 2120-AA66

Modification of VOR Federal Airways V-82, V-175, V-191, and V-430
in the Vicinity of Bemidji, MN

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action modifies the legal description of VHF
omnidirectional range (VOR) Federal Airways V-82, V-175, V-191, and V-
430 in the vicinity of Bemidji, MN. The Bemidji (BJI) VOR, that forms a
segment of these airways, has been out of service for over two years
due to terrain and new construction signal interference problems and is
planned for decommissioning. An airway intersection reporting point is
being established in the same location as the BJI VOR to restore a
navigable route structure to the area similar to what existed prior to
the loss of service from the navigation aid.

DATES: Effective date 0901 UTC, September 23, 2010. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace and Rules
Group, Office of System Operations Airspace and AIM, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On Wednesday, May 5, 2010, the FAA published in the Federal
Register a notice of proposed rulemaking (NPRM) to modify V-82, V-175,
V-191, and V-430 in the vicinity of Bemidji, MN (75 FR 24504).
Interested parties were invited to participate in this rulemaking
effort by submitting written comments on this proposal to the FAA. One
comment was received in response to the proposal.
    The commenter requested the FAA provide at least a fix to replace
the Bemidji VOR. The FAA addressed this comment in the proposal section
of the NPRM. Specifically, the FAA stated, ``To restore the navigable
airway structure in the vicinity of Bemidji, MN, the FAA is proposing
to establish the BLUOX fix in the same location currently depicting the
BJI VOR navigation aid.'' The BLUOX fix, as proposed, is defined by
intersecting airway radials.
    Subsequent to publication, the FAA took action to change the
Decatur (DEC) VHF omni-directional range/tactical air navigation
(VORTAC) name and identifier to the Adders VORTAC (AXC). The DEC VORTAC
name change will only affect V-191 in this rulemaking action.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by modifying V-82, V-175, V-191, and V-430 in the vicinity of
Bemidji, MN. The BJI VOR navigation aid was removed from service in
April 2007, and is being decommissioned. To restore the navigable
airway structure in the vicinity of Bemidji, MN, the FAA is
establishing the BLUOX fix in the same location currently depicting the
BJI VOR. Also, V-430 is rerouted between the BLUOX fix and Grand Forks
VOR (GFK), ND, over the Thief River Falls VOR (TVF), MN. Except for V-
191, which is being modified to terminate at the Grand Rapids VOR
(GPZ), MN, the FAA is modifying the V-82, V-175, and

V-430 legal descriptions to replace the BJI VOR with an airways
intersection point defining the BLUOX fix.
    Additionally, V-191 is being amended to reflect the Decatur VORTAC
name change to Adders VORTAC. The Decatur VORTAC and Decatur Airport
share the same name and facility identifier (DEC), but are not co-
located and are greater than 5 nautical miles apart. To eliminate the
possibility of confusion, and a potential flight safety issue, the
Decatur VORTAC is being renamed the Adders VORTAC and assigned a new
facility identifier (AXC). Accordingly, the V-191 legal description
will be amended to reflect the Adders, IL, [VORTAC] name change.
    VOR Federal airways are published in paragraph 6010(a) of FAA Order
7400.9T signed August 27, 2009 and effective September 15, 2009, which
is incorporated by reference in 14 CFR 71.1. The VOR Federal Airways
listed in this document will be published subsequently in the Order.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under Department of Transportation (DOT) Regulatory Policies and
Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant
preparation of a regulatory evaluation as the anticipated impact is so
minimal. Since this is a routine matter that will only affect air
traffic procedures and air navigation, it is certified that this rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it modifies VOR Federal airways in the vicinity of Bemidji, MN.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, Environmental Impacts: Polices and Procedures,
paragraph 311a. This airspace action is not expected to cause any
potentially significant environmental impacts, and no extraordinary
circumstances exist that warrant preparation of an environmental
assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p.389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the FAA Order
7400.9T, Airspace Designations and Reporting Points, signed August 27,
2009, and effective September 15, 2009, is amended as follows:

Paragraph 6010(a) Domestic VOR Federal Airways
* * * * *

V-82 [Modified]

From Baudette, MN; INT Baudette 194[deg] and Brainerd, MN, 331[deg]
radials; Brainerd; Gopher, MN; Farmington, MN; Rochester, MN;
Nodine, MN; to Dells, WI.
* * * * *

V-175 [Modified]

From Malden, MO; Vichy, MO; Hallsville, MO; Macon, MO; Kirksville,
MO; Des Moines, IA; Sioux City, IA; Worthington, MN; Redwood Falls,
MN; Alexandria, MN; Park Rapids, MN; INT Park Rapids 003[deg] and
Roseau, MN, 160[deg] radials; Roseau; to Winnipeg, MB, Canada. The
airspace within Canada is excluded.
* * * * *

V-191 [Modified]

From Troy, IL; Adders, IL; Roberts, IL; INT Roberts 008[deg] and
Joliet, IL, 067[deg] radials; Northbrook, IL; Badger, WI; Oshkosh,
WI; Rhinelander, WI; Ironwood, MI; Duluth, MN; Hibbing, MN; to Grand
Rapids, MN.
* * * * *

V-430 [Modified]

From Cut Bank, MT, 10 miles, 74 miles 55 MSL; Harve, MT, 14 miles,
100 miles 50 MSL; Glasgow, MT; INT Glasgow 100[deg] and Williston,
ND, 263[deg] radials, 22 miles, 33 miles 55 MSL, Williston; Minot,
ND; Devils Lake, ND; Grand Forks, ND; Thief River Falls, MN; INT
Thief River Falls 122[deg] and Grand Rapids, MN, 292[deg] radials;
Grand Rapids; Duluth, MN; Ironwood, MI; Iron Mountain, MN; to
Escanaba, MI.

    Issued in Washington, DC, on July 16, 2010.
Edith V. Parish,
Manager, Airspace and Rules Group.
[FR Doc. 2010-17953 Filed 7-26-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: October 26, 2007 (Volume 72, Number 207)]
[Rules and Regulations]
[Page 60779-60781]
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. COTP Morgan City--07-018]
RIN 1625--AA00

Safety Zone; Morgan City-Port Allen Alternate Route, Mile Marker
0.5 to Mile Marker 1.0, Bank to Bank

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary Safety Zone on the
Morgan City-Port Allen Alternate Route, from Mile Marker 0.5 to Mile
Marker 1.0, bank to bank. This Safety Zone is needed to protect divers,
vessels, and tows from destruction, loss, or injury from salvage
operations to remove a crane from beneath the Long-Allen Fixed Bridge,
and to facilitate compliance with a court approved Consent Judgment
whereby the crane must be removed prior to December 1, 2007.

DATES: This rule is effective from 6 a.m. on October 29, 2007 until 6
p.m. on November 11, 2007.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of COTP Morgan City-07-018 and are available for
inspection or copying at Marine Safety Unit Morgan City, 800 David
Drive, Morgan City, Louisiana, 70380 between 8 a.m. and 4 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Lieutenant Commander (LCDR) Rick
Paciorka, Marine Safety Unit Morgan City, at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    We did not publish a notice of proposed rulemaking (NPRM) for this
regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing an NPRM, and under 5 U.S.C. 553(d)(3),
good cause exists for making this rule effective less than 30 days
after publication in the Federal Register. Establishment of this safety
zone is required to comply with a Consent Judgment approved by the
Honorable Kurt D. Engelhardt, U.S. District Judge, in his order dated
May 17, 2007. Pursuant to his Order, the Consent Judgment between
Jefferson Marine Towing Inc., et al and the United States requires the
crane to be removed by Jefferson Marine not later than 1 December 2007.
In order to effect the Consent Judgment's court approved deadline, the
U.S. Army Corps of Engineers (ACOE), the U.S. Coast Guard, and
Jefferson Marine met to discuss the parameters of a salvage plan. This
plan was preliminarily approved on 29 August 2007. The preliminary plan
projected salvage operations beginning on 17 September 2007. Given the
potential impact on the public and industry of this near term major
waterway closure, the Coast Guard and the ACOE negotiated a later date
beginning 29 October 2007. This later date allowed for transit planning
that accommodates the vast majority of fall harvest barge movement
while still allowing for completion of the salvage work by the court
ordered deadline. The 29 October date was tentatively agreed upon on 13
September 2007. Publishing an NPRM and delaying its effective date
would be contrary to public interest since immediate action is needed
to protect divers, vessels, and mariners from the hazards associated
with salvage operations in the area, and to facilitate compliance with
the court approved Consent Judgment whereby the salvage operation must
be concluded by 1 December 2007.

Background and Purpose

    Due to an allision with the Long-Allen fixed bridge, a crane was
lost from a barge into the Morgan City-Port Allen Alternate Route.
Salvage operations will be conducted in the vicinity of the Long-Allen
Fixed bridge to recover the crane. The Morgan City-Port Allen Alternate
Route will be closed to marine traffic during salvage operations. This
Safety Zone is needed to protect divers, vessels, and tows from
destruction, loss or injury from the dangers associated with the
salvage operations, and to facilitate compliance with a court approved
Consent Judgment whereby the salvage operation must be concluded by 1
December 2007.

Discussion of Rule

    The Coast Guard is establishing a temporary Safety Zone on the
Morgan City-Port Allen Alternate Route, from Mile Marker 0.5 to Mile
Marker 1.0, bank to bank. The temporary Safety Zone will continue in
effect until the salvage operations are complete. Vessels and tows may
not enter this zone while salvage operations are taking place. This
rule is effective from 6 a.m. on October 29, 2007 until 6 p.m. on
November 11, 2007.

Regulatory Evaluation

    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.
    This rule will only be in effect for a 14 day period of time and
notifications to the marine community will be made through broadcast
notice to mariners. The impacts on routine navigation are expected to
be moderate to great. Vessels may continue to transit through alternate
routes to their destinations.

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 may be small entities: the owners or operators of vessels
intending to transit through the Safety Zone from 6 a.m. CDT on October
29, 2007 until 6 p.m. CST on November 11, 2007. This Safety Zone will
not have a significant economic impact on a substantial number of small
entities because this rule will be in effect for a 14 day period of
time. Additionally, vessels may continue to transit through alternate
routes to their destinations.
    If you are a small business entity and are significantly affected
by this regulation, please contact LCDR Rick Paciorka, Marine Safety
Unit Morgan City, at<PHONE_NUMBER>.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small
entities in understanding the rule so 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).

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 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 significant energy action.
Therefore, it does not require a Statement of Energy Effects under
Executive Order 13211.

Environment

    We have analyzed this rule under Commandant Instruction M16475.1D,
which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have concluded that there are no factors in this case that would limit
the use of a categorical exclusion under section 2.B.2 of the
Instruction. Therefore, this rule is categorically excluded, under
figure 2-1, paragraph (34)(g), of the Instruction, from further
environmental documentation because this rule is not expected to result
in any significant adverse environmental impact as described in NEPA.
    Under figure 2-1, paragraph (34)(g), of the Instruction, an
``Environmental Analysis Check List'' and a ``Categorical Exclusion
Determination'' are not required for this rule.

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; 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. A new temporary Sec.  165.T08-018 is added to read as follows:

Sec.  165.T08-018  Safety Zone; Morgan City-Port Allen Alternate Route,
from Mile Marker 0.5 to Mile Marker 1.0, bank to bank.

    (a) Enforcement Areas. Morgan City-Port Allen Alternate Route, from
Mile Marker 0.5 to Mile Marker 1.0, bank to bank.
    (b) Effective date. This section is effective from 6 a.m. on
October 29, 2007 until 6 p.m. on November 11, 2007.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.33 of this part, entry into this zone is prohibited unless
authorized by the Captain of the Port Morgan City.
    (2) Vessels requiring entry into or passage through the Safety Zone
must

request permission from the Captain of the Port Morgan City, or a
designated representative. They may be contacted on VHF Channel 11, or
by telephone at<PHONE_NUMBER>.
    (3) All persons and vessels shall comply with the instructions of
the Captain of the Port Morgan City and designated on-scene U.S. Coast
Guard patrol personnel. On-scene U.S. Coast Guard patrol personnel
include commissioned, warrant, and petty officers of the U.S. Coast
Guard.

    Dated: October 23, 2007.
J. Scott Paradis,
Captain, U.S. Coast Guard, Captain of the Port Morgan City.
[FR Doc. 07-5354 Filed 10-24-07; 1:09 pm]

BILLING CODE 4910-15-P


[Federal Register: August 28, 2008 (Volume 73, Number 168)]
[Notices]
[Page 50811]
[DOCID:fr28au08-59]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER08-1374-000]

ISO Trader, LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

August 21, 2008.
    This is a supplemental notice in the above-referenced proceeding,
of ISO Trader, LLC's application for market-based rate authority, with
an accompanying rate schedule, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability is September 11, 2008.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above-referenced proceeding(s) are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-19926 Filed 8-27-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 116 (Friday, June 15, 2012)]
[Rules and Regulations]
[Pages 35852-35854]
[FR Doc No: 2012-14709]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2012-0488]
RIN 1625-AA00

Safety Zones; Multiple Firework Displays in Captain of the Port,
Puget Sound Zone

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing safety zones in Boston Harbor,
Holmes Harbor, Port Gardner and Port Townsend for various summer
fireworks displays. The safety zones are necessary to help ensure the
safety of the maritime public during the displays and will do so by
prohibiting all persons and vessels from entering the safety zones
unless authorized by the Captain of the Port or his designated
representative.

DATES: This rule is effective from 5 p.m. on July 3, 2012, until 1 a.m.
on July 5, 2012.

ADDRESSES: Documents mentioned in this preamble are part of docket
USCG-2012-0488. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 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 email ENS Anthony P. LaBoy, Coast Guard Sector Puget Sound,
Waterways Management Division; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call

Renee V. Wright, Program Manager, Docket Operations, telephone (202)
366-9826.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Given the short time until the fireworks displays commence,
it would be impracticable to issue an NPRM and subsequent final rule
before the commencement of the fireworks displays. For that reason, we
find there is good cause to issue this final rule without notice and
comment.
    Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause
exists for not publishing a notice of proposed rulemaking (NPRM) with
respect to this rule because to do so would be impracticable, since the
events would be over before notice could be given and comments taken,
and it is immediately necessary to protect the events' spectators from
the hazards associated with fireworks displays.

B. Basis and Purpose

    (a) The authority for this action can be found in 33 CFR 1.05-1(f).
    (b) Fireworks displays create hazardous conditions for the maritime
public because of the large number of vessels that congregate near the
displays as well as the noise, falling debris, and explosions that
occur during the event. The establishment of a safety zone around
displays helps to ensure the safety of the maritime public by
prohibiting all persons and vessels from coming too close to the
fireworks display and the associated hazards.

C. Discussion of the Final Rule

    This rule establishes four safety zones for the following firework
displays: Boston Harbor Fireworks on July 3, 2012 in Boston Harbor near
Olympia, WA; Celebrate America Festival on July 3, 2012 in Holmes
Harbor near Freeland, WA; Everett 4th of July Foundation on July 4,
2012 in Port Gardner near Everett, WA; and Port Townsend July 4th
Fireworks on July 4, 2012 in Port Townsend near Point Hudson. All
persons and vessels will be prohibited from entering the safety zones
during the dates and times they are effective unless authorized by the
Captain of the Port or his Designated Representative.

D. 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.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. This rule is not a
significant regulatory action because it creates safety zones that are
minimal in size and short in duration.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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 may be
small entities: The owners or operators of vessels intending to transit
through the established safety zones during the times of enforcement.
This rule will not have a significant economic impact on a substantial
number of small entities because the temporary safety zones are minimal
in size and short in duration, maritime traffic will be able to transit
around them and may be permitted to transit them with permission from
the Captain of the Port or his designated representative.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    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.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INTFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

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

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. 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.

10. 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.

11. 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.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. 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 determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves the establishment of safety zones. This
rule is categorically excluded from further review under paragraph
34(g) of Figure 2-1 of the Commandant Instruction. An environmental
analysis checklist and a categorical exclusion determination are
available in the docket where indicated under ADDRESSES. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this rule.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapters 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.T13-220 to read as follows:

Sec.  165.T13-220  Safety Zones; Multiple Firework Displays in Captain
of the Port, Puget Sound Zone

    (a) Location. The following areas are designated as safety zones:
    (1) Boston Harbor Fireworks, Boston Harbor, Olympia, WA: All waters
of Boston Harbor encompassed within a 100 yard radius around position
47[deg]08.626' N, 122[deg]54.149' W.
    (2) Celebrate America Festival, Holmes Harbor, Freeland, WA: All
waters of Holmes Harbor encompassed within a 200 yard radius around
position 48[deg]01.048' N, 122[deg]31.866' W.
    (3) Everett Fourth of July Foundation, Port Gardner, Everett, WA:
All waters of Port Gardner encompassed within a 300 yard radius around
position 48[deg]00.672' N, 122[deg]13.391' W.
    (4) Port Townsend July 4th Fireworks, Point Hudson, Port Townsend,
WA: All waters of Port Townsend encompassed within a 150 yard radius
around position 48[deg]06.900' N, 122[deg]45.120' W.
    (b) Regulations. In accordance with the general regulations in 33
CFR part 165, subpart C, no person or vessel may enter or remain in the
safety zone created by this section without the permission of the
Captain of the Port or his designated representative. Designated
representatives are Coast Guard Personnel authorized by the Captain of
the Port to grant persons or vessels permission to enter or remain in
the safety zone created by this section. See 33 CFR part 165, Subpart
C, for additional information and requirements.
    (c) Enforcement Period. The safety zones created by this section
will be enforced as follows:
    (1) Boston Harbor Fireworks, Boston Harbor, Olympia, WA: 5 p.m. on
July 3, 2012 until 1 a.m. on July 4, 2012.
    (2) Celebrate America Festival, Holmes Harbor, Freeland, WA: 5 p.m.
on July 3, 2012 until 1 a.m. on July 4, 2012.
    (3) Everett Fourth of July Foundation, Port Gardner, Everett, WA: 5
p.m. July 4, 2012 until 1 a.m. on July 5, 2012.
    (4) Port Townsend July 4th Fireworks, Point Hudson, Port Townsend,
WA: 5 p.m. on July 4, 2012 until 1 a.m. on July 5, 2012.

    Dated: June 1, 2012.
S.J. Ferguson,
Captain, U.S. Coast Guard, Captain of the Port, Puget Sound.
[FR Doc. 2012-14709 Filed 6-14-12; 8:45 am]
BILLING CODE 9110-04-P


EXAMPLE PROCEDURE FOR FIELD FILTERING SAMPLES FOR CRYPTOSPORIDIUM ANALYSIS USING IDEXX FILTA MAX   FILTERS JUNE 2003 DRAFT Draft June 2003 1 Example Procedure for Field Filtering Samples for Cryptosporidium Analysis Using IDEXX Filta Max   Filters 1.0 Required Materials Check to make sure the following materials are available before collecting your sample:

Q Several pairs of new, powder free latex gloves ( Lab Safety Supply, cat. number 16285XL, or equivalent)

Q Sample collection form Q Filta Max   foam filter module ( IDEXX, cat. number, FMC 10603) with housing ( IDEXX, cat. number, FMC 10504)

Q Electric peristaltic pump ( Masterflex L/ S variable speed drive, Cole Parmer, cat. number LC 07554 90, or equivalent with Masterflex L/ S Easy Load II pump head, Cole Parmer, cat. number LC 77200 60, or equivalent) ( for use only for collection of samples from an unpressurized source)

Q One length of peristaltic pump tubing ( Masterflex C Flex LS 18 tubing, Cole Parmer, cat. number EW 06424 18, or equivalent)

Q Four lengths of 12.7 mm ( 0.5 in.) internal diameter clear laboratory tubing ( Tygon formula R 3603 [ Cole Parmer, cat. number, 06408 18], or equivalent)

Q Four pairs of clamps fit to tubing Q One coupling to fit 0.5 in. internal diameter tubing Q Pressure regulator ( Watts Regulator, cat. number, 263A, or equivalent)

Q Pressure gauge ( maximum operating pressure 120 psi) ( Cole Parmer, cat. number, E 68004 05, or equivalent)

Q Water meter ( flow totalizer) ( Omega Engineering, cat. number, FTB 4005, or equivalent)

Q Flow rate meter ( Blue White, cat. number, F4437LEA 8, or equivalent)

Q Flow control valve ( Plast o matic, model number # FC050B 1/ 2 PV)

Q Sample number label Q Cooler, approximately 16 quart ( Coleman, model number, 6216 703, or equivalent)

Q Two large plastic trash bags Q One 8 lb bag of ice Q Gel ice pack ( VWR, cat. number, 15715 105, or equivalent)

Q Three 13 × 18 inch ziplock bag ( Associated Bag, cat. number, 270 42, or equivalent)

Q Strapping tape Q Two, self adhesive plastic airbill sleeves Q Airbill for shipment Draft June 2003 2 2.0 Collecting the Sample If the sample will be collected from a pressurized source, use the sample collection procedures in Section 2.1. If the sample will be collected from an unpressurized source, use the sample collection procedures in Section 2.2.

2.1 Sample Filtration from a Pressurized Source 2.1.1 Before connecting the sampling system to the tap or source, turn on the tap and allow the water to flow for 2 to 3 minutes or until any debris that has accumulated in the source water lines has cleared or the turbidity in the water becomes visibly uniform. Turn off the tap.

2.1.2 Put on a pair of powder free latex gloves to prevent contamination from outside sources. Any contamination of the sampling apparatus may bias the final results.

2.1.3 Determine the pressure of the water supply using a pressure gauge.

2.1.4 Assemble the sampling system, minus the Filta Max   filter. For high pressure (> 20 psig) sites, the sampling system should be assembled at the sample port valve in the following order:

Q Reinforced influent tubing Q Pressure regulator Q Pressure gauge Q Reinforced inlet tubing Q Filta Max   filter housing Q Reinforce outlet tubing Q Flow totalizer ( mechanical or graduated collection device)

Q Flow control valve or flow rate meter with valve Q Effluent tubing to drain For a low pressure ( 7.5 to 20 psig) site, the sampling system should be assembled at the sample port valve in the following order:

Q Influent tubing Q Filta Max   filter housing Q Outlet tubing Q Flow rate meter with valve Q Flow totalizer ( mechanical or graduated collection device)

Q Effluent tubing to drain 2.1.5 Connect the sampling system, with an empty Filta Max   filter housing, to the pressurized water system. Verify that the filter housing is installed so that the end closest to the screw top cap is the inlet and the opposite end is the outlet.

2.1.6 Slowly turn the tap to fully open. Allow a minimum of 20 L to flush the system. During this period, perform the following steps: Draft June 2003 3 <IP_ADDRESS> Measuring flow rate with the flow rate meter or the flow totalizer and a stopwatch, adjust the flow rate to approximately 3  4 L/ min ( approximately 0.8  1 gpm). At high pressure sites, using the pressure regulator, adjust the pressure to a maximum of 120 psi. Observe system for leaks and take the necessary corrective action if any are present. A differential pressure of 7.5 psi is required to create flow through the filter. The recommended differential pressure to produce the flow rate of 3 to 4 L/ min is 75 psi. Do not exceed the maximum operating pressure of 120 psig.

<IP_ADDRESS> Record the following information on the sample collection form:

O Public water system ( PWS) name O PWS address O Sampler name O Sample ID ( optional)

O Public Water System Identification ( PWS ID) number O Public Water System facility ID number O Facility name O Sample collection point ID O Sample collection point name O Sample collection date O Source water type ( optional [ but required for E. coli sample forms])

O Requested analysis ( circle Cryptosporidium field sample for routine monitoring sample; circle both " Cryptosporidium field sample" and " Cryptosporidium matrix spike" sample if you are sending an additional sample with the monitoring sample for matrix spike analysis)

<IP_ADDRESS> After the system has been flushed, any optional water quality parameters such as temperature, pH, and/ or turbidity should be measured now.

2.1.7 Turn off the water at the sample port valve when the flow rate has been adjusted and the system has been flushed.

2.1.8 Record the following information on the sample collection form:

O Current meter reading 2.1.9 Install the Filta Max   filter into the housing and secure the housing cap by hand tightening. Apply gentle pressure to create a seal between the module and the " O" rings in the base and lid of the housing. Excessive tightening is not necessary, and may shorten the life of the " O" rings. A light application of vacuum grease may be used to lubricate the " O" rings, but too much grease will produce a negative effect.

Note! Retain the end caps provided with the filter housing. These caps will be needed to seal the housing for shipment. Draft June 2003 4 2.1.10 Turn on the pressurized water source. Adjust flow to within 3 to 4 L/ min, if necessary.

O Record start time on the sample collection form.

2.1.11 Monitor the water meter. When the targeted volume ( typically 10 L [ 2.64 gal] or 50 L [ 13.2 gal]) has passed through the Filta Max   filter, shut off the water source. Allow the pressure to decrease until the water stops.

2.1.12 Record the following information on the sample collection form:

O Stop time ( when the water was shut off)

O Final meter reading O Comments to laboratory, if needed 2.1.13 Disconnect the inlet end of the filter housing, making sure not to spill any of the water remaining in the capsule. This water is part of your sample.

2.1.14 The filter can either be shipped in the filter housing or removed from the filter housing and shipped alone.

2.1.15 If the filter will be shipped without the housing, open the housing and dump the filter and any water remaining in the housing into a ziplock bag. Place this bag inside a second ziplock bag and seal.

2.1.16 If the filter will be shipped in the housing, seal the inlet and outlet of the housing with the rubber stoppers that were previously saved. Place the filter housing containing the filter in a plastic ziplock bag for shipment.

2.1.17 Place a label on the outer ziplock bag containing the filter and using a waterproof pen record the following information:

O PWS ID O Facility name O Date of sample collection Cover the label with clear tape to keep the label dry.

2.1.18 Immediately following sample collection, place the bag containing the filter ( with or without filter housing) in a refrigerator to chill prior to packing the shipping cooler for shipment. If no refrigerator is available, and the sample will not be shipped for several hours, place the bag in the shipping cooler with ice to chill, and replace the ice before shipping.

Note! Method 1622/ 1623 requires that the temperature of the sample upon arrival at the laboratory must be < 10 ° C ( but not frozen), and the laboratory must have the filter processed within 96 hours of sample collection. If the sample temperature and holding time requirements are not met, then the sample is invalid and must be recollected.

As a recommendation, it is best to have the filter processed by the laboratory within 24 hours of sampling. Draft June 2003 5 2.2 Sample Filtration from an Unpressurized Source 2.2.1 Put on a pair of powder free latex gloves to prevent contamination from outside sources. Any contamination of the sampling apparatus may bias the final results.

2.2.2 If sampling from a source of unlimited volume, it may be desirable to pre flush the sampling system. Assemble the sampling system, minus the Filta Max   filter. Verify that the filter housing is installed so that the end closest to the screw top cap is the inlet and the opposite end is the outlet. The sampling system should be assembled in the following order:

Q Influent tubing Q Peristaltic pump Q Filta Max   filter housing Q Outlet tubing Q Flow rate meter with valve Q Flow totalizer ( mechanical or graduated container)

Q Effluent tubing to drain 2.2.3 Place the inlet end of the inlet tubing in sample source, away from any walls, bottom, or other environmental surfaces.

2.2.4 Turn on the pump and allow a minimum of 20 L to flush the system. If sampling source water from a carboy, continuously refill the carboy as necessary to flush the system. As a recommendation, the carboy should not be removed from the sampling chain and should be refilled using a separate container. Observe the system for leaks and take the necessary corrective action if any are present. During this period, perform the following steps:

<IP_ADDRESS> Measuring flow rate with the flow rate meter or the flow totalizer and a stopwatch, adjust the flow rate to approximately 3  4 L/ min ( approximately 0.8  1 gpm) by varying the pump speed or adjusting the valve ( if pump is not variable speed).

<IP_ADDRESS> Record the following information on the sample collection form:

O Public water system ( PWS) name O PWS address O Sampler name O Sample ID ( optional)

O Public Water System Identification ( PWS ID) number O Public Water System facility ID number O Facility name O Sample collection point ID O Sample collection point name O Sample collection date O Source water type ( optional [ but required for E. coli sample forms]) Draft June 2003 6 O Requested analysis ( circle Cryptosporidium field sample for routine monitoring sample; circle both " Cryptosporidium field sample" and " Cryptosporidium matrix spike" sample if you are sending an additional sample with the monitoring sample for matrix spike analysis)

<IP_ADDRESS> Once the system has been flushed, any optional water quality parameters such as temperature, pH, and/ or turbidity should be measured now.

2.2.5 Turn off the pump when the flow rate has been adjusted and the system has been flushed. Following flushing, or if flushing is not performed, proceed with the following steps:

2.2.6 Record the following information on the sample collection form:

O Current meter reading 2.2.7 Install the Filta Max   filter into the housing and secure the housing cap by hand tightening. Apply gentle pressure to create a seal between the module and the " O" rings in the base and lid of the housing. Excessive tightening is not necessary, and may shorten the life of the " O" rings. A light application of vacuum grease may be used to lubricate the " O" rings, but too much grease will produce a negative effect.

Note! Retain the end caps provided with the filter housing. These caps will be needed to seal the housing for shipment.

2.2.8 Turn on the peristaltic pump. Record the following on the sample collection form:

O Start time 2.2.9 Monitor the water meter. When the targeted volume ( typically 10 L [ 2.64 gal] or 50 L [ 13.2 gal]) has passed through the Filta Max   filter or the container is depleted, remove the inlet tubing from the source. Shut off the pump when all the water has been forced through the filter. Allow the pressure to decrease until the water stops. If sampling from a container, add 1 L of reagent water per every 10 L container volume and rinse the sides of the container. Resume pumping until the rinse volume is filtered.

2.2.10 Record the following information on the sample collection form:

O Stop time ( when the pump was shut off)

O Final meter reading or measured total volume sample, not including reagent rinse volume, if any O Comments to laboratory, if needed 2.2.11 Disconnect the inlet end of the filter housing, making sure not to spill any of the water remaining in the capsule. This water is part of your sample.

2.2.12 The filter can either be shipped in the filter housing or removed from the filter housing and shipped alone.

2.2.13 If the filter will be shipped without the housing, open the housing and dump the filter and any water remaining in the housing into a ziplock bag. Place this bag inside a second ziplock bag and seal. Draft June 2003 7 2.2.14 If the filter will be shipped in the housing, seal the inlet and outlet of the housing with the rubber stoppers that were saved previously. Place the filter housing containing the filter in a plastic ziplock bag for shipment.

2.2.15 Place a label on the outer ziplock bag containing the filter and using a waterproof pen record the following information:

O PWS ID O Facility name O Date of sample collection Cover the label with clear tape to keep the label dry.

2.2.16 Immediately following sample collection, place the bag containing the filter housing in a refrigerator to chill prior to packing the shipping cooler for shipment. If no refrigerator is available, and the sample will not be shipped for several hours, place the bag in the shipping cooler with ice to chill. Replace the ice before shipping.

Note! Method 1622/ 1623 requires that the temperature of the sample upon arrival at the laboratory must be < 10 ° C ( but not frozen), and the laboratory must have the filter processed within 96 hours of sample collection. If the sample temperature and holding time requirements are not met, then the sample is invalid and must be recollected.

As a recommendation, it is best to have the filter processed by the laboratory within 24 hours of sampling.

3.0 Packing the Sample 3.1 Insert two large plastic trash bags into the shipping cooler to create a double liner. Immediately before packing the cooler, create two 4 lb ice packs by putting half of an 8 lb bag of ice into two separate ziplock bags. To prevent leaks place each ice pack into an additional ziplock bag. Gel packs or blue ice may be used instead of wet ice, as long as the sample is maintained in the appropriate temperature range. Seal the ziplock bag, expelling as much air as possible, and secure top with tape.

Note! Shipping companies may delay sample shipments if leakage occurs. Double liners and ziplock bags around ice will prevent leakage and delays.

3.2 Place the bag containing the filter housing into the shipping container. Place the ice pack around, but not on, the sample bag to prevent freezing. Inflated, empty sample bags can be placed between the filter housing and the ice packs to prevent the filter from freezing.

3.3 If you will be monitoring sample temperature during shipment, place in the cooler the temperature monitoring device ( e. g., extra sample bottle for measuring sample temperature upon receipt at the laboratory, thermometer vial, or Thermochron   iButton). Seal each liner bag by twisting top of bag and tying in a knot. Draft June 2003 8 3.4 Peel the backing off one of the plastic airbill sleeves and attach the sleeve to the inside of the cooler lid.

O Sign and date the sample collection form Fold the completed sample collection form, and place it inside the plastic sleeve.

3.5 Close the cooler lid, seal the horizontal joints with duct tape, and secure the lid with tape by taping the cooler at each end, perpendicular to the seal.

Note! Shipping companies may delay sample shipments if leakage occurs. Be sure to seal the cooler joints.

3.6 Peel the backing off of the second airbill sleeve and attach the sleeve to the outside of the cooler lid. Complete the shipping airbill with the laboratory address, billing information, sample weight, and shipping service. Remove the shipper's copy of the airbill, and place the remainder of the airbill inside the plastic sleeve.

4.0 Shipping and Tracking 4.1 Ship samples on the day of collection and use a reliable shipping service for next day delivery. If samples are not shipped the day of collection, the sample must be maintained at < 10 ° C ( but not frozen) by chilling in a refrigerator or cooler filled with ice.

4.2 Contact the laboratory to notify them of the sample shipment. Request that the laboratory contact you the next day if the sample is not received.

4.3 Using the airbill number on the shipper's copy of the airbill, track the sample shipment using the shipping company's web page or by contacting the shipping company over the phone.

4.4 If problems are encountered with the shipment, communicate with the shipping company to resolve, and update the laboratory regarding the status of the shipment.


[Federal Register Volume 76, Number 135 (Thursday, July 14, 2011)]
[Notices]
[Pages 41506-41507]
[FR Doc No: 2011-17671]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0215]

Draft Guidance for Industry and FDA Staff on In Vitro Companion
Diagnostic Devices; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``In Vitro Companion
Diagnostic Devices.'' This guidance is intended to assist sponsors
planning to develop a therapeutic product that depends on the use of an
in vitro companion diagnostic device for its safe and effective use or
an in vitro diagnostic device that is intended for use with a
corresponding therapeutic product and included in the instructions for
use in the labeling of those products. This guidance defines in vitro
companion diagnostic devices; explains the need for FDA oversight of
companion diagnostic devices; clarifies that, in most circumstances, if
use of a companion diagnostic device is essential for the safe and
effective use of a therapeutic product, the diagnostic device and
therapeutic product should be approved or cleared contemporaneously by
FDA for the use indicated in the therapeutic product labeling; provides
guidance for industry and FDA staff on possible premarket regulatory
pathways and FDA's regulatory enforcement policy; and describes certain
statutory and regulatory approval requirements relevant to therapeutic
product labeling that stipulate concomitant use of a companion
diagnostic device to ensure safety and effectiveness of the therapeutic
product. This draft guidance is not final, nor is it in effect at this
time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 12, 2011.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``In Vitro Companion Diagnostic Devices'' to
the Division of Small Manufacturers, International, and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver
Spring, MD 20993-0002. Send a fax request to<PHONE_NUMBER> to receive a
hard copy. Alternatively, you may submit written requests for single
copies of the draft guidance to the Division of Drug Information,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-
0002, or Office of Communication, Outreach and Development (HFM-40),
1401 Rockville Pike, suite 200N, Rockville, MD 20852. Send one self-
addressed adhesive label to the office that you are ordering from to
assist in processing your requests. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Mansfield, Center for
Devices and Radiologic Health, Food and Drug Administration, Bldg. 66,
rm. 5676, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-
4664; or Christopher Leptak, Office of Translational Sciences, Center
for Drug Evaluation and Research, Food and Drug Administration, Bldg.
22, rm. 5102, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-0017; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry and FDA staff entitled
``In Vitro Companion Diagnostic Devices.'' This guidance is intended to
provide assistance both to sponsors developing therapeutic products,
which for purposes of this guidance includes therapeutic, preventive,
or prophylactic drugs and biological products that depend on the use of
and are labeled for use with an in vitro diagnostic device, and to
sponsors of the companion diagnostics. This guidance defines
``companion diagnostic device'' and clarifies that in most
circumstances, if use of a companion diagnostic device is essential for
the safe and effective use of a therapeutic product, the diagnostic
device and therapeutic product should be approved or cleared
contemporaneously by FDA for the use indicated in the therapeutic
product labeling.
    Diagnostic tests have been employed for many years to enhance the
use of therapeutic products. Recently, therapeutic products that depend
on the use of a diagnostic test to meet their labeled safety and
effectiveness claims have become more common. For example, a test could
identify or limit appropriate populations for treatment or identify
populations who should not receive a particular treatment because of

the increased risk of a serious side effect. Another reason for this
increasing interest is the emergence of new technologies that are
improving our ability to individualize, or personalize, medical therapy
by identifying patients who are more likely to respond positively or
negatively to treatment, or who are at lower risk for a particular side
effect.
    When an appropriate scientific rationale supports such an approach,
FDA encourages the development and use of therapeutic products that
depend on the use of approved or cleared companion diagnostic devices,
and the Agency has already approved/cleared several companion
diagnostics for use with corresponding therapeutic products. FDA
believes that use of a companion diagnostic with a therapeutic product
raises important concerns about the safety and effectiveness of both
the test and the therapeutic product. An erroneous test result could
lead to withholding an appropriate therapy or to administering an
inappropriate therapy. Healthcare professionals must be able to rely on
information from companion diagnostic devices to help make critical
treatment decisions. FDA oversight of companion diagnostics will
protect patients from treatment risks that could arise from in vitro
companion diagnostic devices that have inadequate performance
characteristics. To facilitate the development and clearance or
approval of therapeutic products that are intended for use with
companion diagnostic devices, as well as the development of the
companion diagnostics themselves, FDA is clarifying relevant policies
related to these devices and products.

II. Significance of Guidance

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

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationsGuidance/GuidanceDocuments/_default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
``In Vitro Companion Diagnostic Devices'', you may either send an e-
mail request to<EMAIL_ADDRESS>to receive an electronic copy of the
document or send a fax request to<PHONE_NUMBER> to receive a hard copy.
Please use the document number 1737 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations and guidance documents. These
collections of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in 21 CFR Part
807 Subpart E have been approved under OMB control number 0910-0120;
the collections of information in 21 CFR Part 314 have been approved
under OMB control number 0910-0001; the collections of information in
21 CFR Part 312 have been approved under OMB control number 0910-0014;
the collections of information in 21 CFR Part 601 have been approved
under OMB control number 0910-0338; the collections of information in
21 CFR Part 814, subparts B and E, have been approved under OMB Control
No. 0910-0231; the collections of information in 21 CFR Part 812 have
been approved under OMB control number 0910-0078; the collections of
information in 21 CFR Part 801 and 21 CFR 809.10 have been approved
under OMB Control No. 0910-0485; and the collections of information in
21 CFR 201.56 and 21 CR 201.57 have been approved under OMB control
number 0910-572.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 8, 2011.
 Nancy K. Stade,
 Deputy Director for Policy, Center for Devices and Radiological
Health.
[FR Doc. 2011-17671 Filed 7-12-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 44 (Tuesday, March 6, 2012)]
[Notices]
[Page 13316]
[FR Doc No: 2012-5340]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL12-2-000]

Southwest Power Pool, Inc.; Notice of Initiation of Proceeding
and Refund Effective Date

    On February 29, 2012, the Commission issued an order that initiated
a proceeding in Docket No. EL12-2-000, pursuant to section 206 of the
Federal Power Act (FPA), 16 U.S.C. 824e (2006), to determine the
justness and reasonableness of certain language in section VII.8(b) of
Attachment O of Southwest Power Pool's existing open access
transmission tariff. Southwest Power Pool, Inc., 138 FERC ] 61,150
(2012).
    The refund effective date in Docket No. EL12-2-000, established
pursuant to section 206(b) of the FPA, will be the date of publication
of this notice in the Federal Register.

    Dated: February 29, 2012.
 Nathaniel J. Davis, Sr.,
 Deputy Secretary
[FR Doc. 2012-5340 Filed 3-5-12; 8:45 am]
BILLING CODE 6717-01-P