[Federal Register Volume 82, Number 58 (Tuesday, March 28, 2017)]
[Rules and Regulations]
[Pages 15287-15290]
[FR Doc No: 2017-05771]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-3705; Directorate Identifier 2015-NM-168-AD;
Amendment 39-18837; AD 2017-06-13]
RIN 2120-AA64

Airworthiness Directives; Textron Aviation Inc. (Type Certificate
Previously Held by Cessna Aircraft Company) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Textron Aviation Inc. (Textron) Model 680 airplanes. This AD was
prompted by Textron's report of a manufacturing defect that affects the
durability of the aft canted bulkhead metallic structure. This AD
requires repetitive inspections of the aft canted bulkhead; repair if
necessary; and a modification, which would terminate the repetitive
inspections. We are issuing this AD to address the unsafe condition on
these products.

DATES: This AD is effective May 2, 2017.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of May 2, 2017.

ADDRESSES: For service information identified in this final rule,
contact Textron Aviation Inc., P.O. Box 7706, Wichita, KS 67277;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
Internet https://support.cessna.com/custsupt/csupport/newlogin.jsp. You
may review this referenced service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>. It
is also available on the Internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2016-3705.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
3705; 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 (phone: 800-647-
5527) is Docket 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: Phuoc Le, Aerospace Engineer, Airframe
Branch, ACE-118W, Wichita Aircraft Certification Office (ACO), FAA,
1801 Airport Road, Room 100, Dwight D. Eisenhower Airport, Wichita, KS
67209; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Textron Aviation
Inc. Model 680 airplanes. The NPRM published in the Federal Register on
February 26, 2016 (81 FR 9790) (``the NPRM''). The NPRM was prompted by
Textron's report of a manufacturing defect that affects the durability
of the aft canted bulkhead metallic structure. The manufacturing defect
directly affects the bond integrity of the vertical and horizontal
stiffeners on the aft canted bulkhead metallic structure. The NPRM
proposed to require repetitive inspections of the aft canted bulkhead
and repair if necessary. The NPRM also proposed to require a
modification which would terminate the repetitive inspections. We are
issuing this AD to prevent disbonding of the horizontal and vertical
stiffeners on the aft canted bulkhead. Loss of bond integrity could
result in a structural failure that could lead to separation of the
cruciform tail and loss of control of the airplane.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the NPRM and
the FAA's response to each comment.

Request To Limit Findings to ``Disbonding''

    NetJets Aviation, Inc. (NetJets) requested that we revise paragraph
(h) of the proposed AD to remove ``cracked paint'' as a possible
finding from the inspection. NetJets acknowledged that cracked paint,
while not a safety concern on its own, should be investigated to ensure
that it is not evidence of disbonding. NetJets indicated that the
requirement for a disbond to be repaired per an alternative method of
compliance (AMOC) is sufficient to ensure that the safety concern is
addressed appropriately.
    We agree with the commenter that cracked paint may not be a safety
concern on its own; however it is evidence that a disbond of the
structure may have occurred and should be investigated further to
ensure there is no evidence of disbonding. Thus, if cracked paint is
found, operators must contact the FAA for procedures to determine
whether the cracked paint was an indication of disbonding. We have
revised paragraph (h) of this AD to clarify that operators must obtain
instructions from the FAA and comply with those instructions.

Request To Have Cessna Engineering Drawing Be Made Available

    NetJets indicated that paragraph (n)(2) of the proposed AD states
that the required service information is available from Textron.
However, Netjets stated that Textron does not provide owners/operators
with access to Cessna Engineering Drawing 6991115 (``Drawing
6991115''), which is required for compliance with paragraph (i) of the
proposed AD. NetJets added that the required service information is not
available at the Federal Register and is not available to owners/
operators through the source identified in the proposed AD. NetJets
indicated that Cessna Service Bulletin SB680-53-08, dated September 28,
2015, states that only Textron-owned service centers can complete the
modification and have access to Drawing 6991115. NetJets stated that
access to Drawing 6991115 should be made available to owners/operators,
and the proposed AD should

state that compliance at a Textron-owned service center is not required
by the AD.
    We acknowledge that Drawing 6991115 is not available to owners/
operators. However, drawing 6991115 is only used for an airplane that
is modified at a Textron-owned service center. Cessna Service Bulletin
SB680-53-08, Revision 2, dated November 2, 2016 (``SB680-53-08,
Revision 2'') (issued after the NPRM was published), includes a
reference to Cessna Engineering Drawing 6991119 (``Drawing 6991119''),
which should be available to owners/operators and contains approved
data for owners/operators who choose to modify their airplanes at a
non-Textron-owned service center. We have revised paragraph (i) of this
AD to refer to SB680-53-08, Revision 2.

Request To Include the Revision Level for Cessna Engineering Drawing

    NetJets requested that the revision level for Drawing 6991115 be
added to paragraph (i) of the proposed AD, and that paragraph (i) of
the proposed AD allow later revisions to Drawing 6991115. Paragraph (i)
of the proposed AD would require compliance with Cessna Service
Bulletin SB680-53-08, dated September 28, 2015, which contains a
reference to the modification instructions contained in Drawing
6991115. Because neither Cessna Service Bulletin SB680-53-08, dated
September 28, 2015, nor paragraph (i) of the proposed AD specifies the
revision level of Drawing 6991115 that would be required for compliance
with the proposed AD, NetJets asserted that it is not possible for an
owner/operator to comply with its responsibility to ensure that FAA
approval was obtained.
    We partially agree that there is a need to specify acceptable
revision levels of Drawing 6991115. However, with the release of SB680-
53-08, Revision 2, Drawing 6991115 is no longer applicable for the
owners/operators who elect to accomplish SB680-53-08, Revision 2, at a
non-Textron facility. Instead, the revision levels of Drawing 6991119
are now applicable for the owners/operators who will accomplish SB680-
53-08, Revision 2, at a non-Textron facility. Although SB680-53-08,
Revision 2, specifies using the latest revision of Drawing 6991119,
this AD allows use of any revision level of that drawing. We have added
paragraph (k) to this AD to specify this provision; subsequent
paragraphs have been redesignated accordingly. We have reviewed all
existing revisions of Drawing 6991119, and have found all to be
acceptable. In addition, paragraph (i) of this AD has been revised to
specify compliance with SB680-53-08, Revision 2.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD with the changes described previously and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Related Service Information Under 1 CFR Part 51

    We reviewed the following Cessna service information.
     Cessna Service Letter SL680-53-05, Revision 2, dated
September 30, 2015. The service information describes procedures for a
general visual inspection for disbonding and paint cracking around the
edges of the stiffeners on the aft canted bulkhead.
     Cessna Service Bulletin SB680-53-08, Revision 2, dated
November 2, 2016. The service information describes procedures for
modifying the airplane by installing additional stiffeners to the aft
canted bulkhead.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 123 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
            Action                   Labor cost         Parts cost      Cost per product          operators
----------------------------------------------------------------------------------------------------------------
Inspection....................  1 work-hour x $85                 $0  $85 per inspection    $10,455 per
                                 per hour = $85 per                    cycle.                inspection cycle.
                                 inspection cycle.
Modification..................  180 work-hours x $85           3,190  18,490..............  2,274,270.
                                 per hour = $15,300.
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    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this AD.
    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

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

    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),
    (3) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    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 FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2017-06-13 Textron Aviation Inc. (Type Certificate Previously Held
by Cessna Aircraft Company): Amendment 39-18837; Docket No. FAA-
2016-3705; Directorate Identifier 2015-NM-168-AD.

(a) Effective Date

    This AD is effective May 2, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Textron Aviation Inc. (Type Certificate
previously held by Cessna Aircraft Company) Model 680 airplanes,
certificated in any category, as identified in paragraphs (c)(1) and
(c)(2) of this AD.
    (1) Model 680 Sovereign airplanes (commonly known as Citation
Sovereign airplanes), having serial numbers: 680-0001, -0002, -0006,
-0025, -0030, -0031, -0032, -0046, -0051, -0057, -0064, -0066, -
0067, -0082, -0104, -0108, -0112, -0118, -0120, -0125, -0132, -0139,
-0140, -0141, -0144, -0147, -0148, -0149, -0153, -0157, -0160, -
0162, -0163, -0164, -0166, -0167, -0169, -0170, -0171, -0173, -0174,
-0175, -0176, -0177, -0178, -0179, -0180, -0182, -0183, -0185, -
0186, -0192, -0193, -0196, -0200, -0202, -0204, -0205, -0206, -0208,
-0211, -0216, -0220, -0221, -0222, -0227, -0229, -0230, -0231, -
0234, -0235, -0236, -0238, -0241, -0242, -0243, -0245, -0246, -0249,
-0252, -0253, -0255, -0256, -0257, -0258, -0260, -0262, -0268, -
0270, -0271, -0280, -0282, -0283, -0284, -0285, -0289, -0291, -0292,
-0296, -0297, -0300, -0301, -0302, -0303, -0304, -0306, -0307, -
0313, -0315, -0317, -0318, -0322, -0323, -0324, -0327, -0328, -0329,
-0333, -0334, -0336, -0337, -0339, -0340, -0342, -0344, -0346, -
0347, -0348, and -0349.
    (2) Model 680 Sovereign airplanes (commonly known as Citation
Sovereign+ airplanes) having serial numbers: 680-0501, -0504, -0505,
-0509, -0510, -0511, -0512, -0513, -0514, -0515, -0516, -0517, -
0519, -0520, -0522, -0524, -0525, -0526, -0527, and -0531.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by Textron's report of a manufacturing
defect which affects the durability of the aft canted bulkhead
metallic structure. The manufacturing defect directly affects the
bond integrity of the vertical and horizontal stiffeners on the aft
canted bulkhead metallic structure. We are issuing this AD to
prevent disbonding of the horizontal and vertical stiffeners on the
aft canted bulkhead. Loss of bond integrity could result in a
structural failure that may lead to separation of the cruciform tail
and loss of control of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Repetitive Inspections

    Before the accumulation of 7,000 total flight hours, or within
100 flight hours after the effective date of this AD, whichever
occurs later, perform a general visual inspection for disbonding and
paint cracking around the edges of the stiffeners on the aft canted
bulkhead, in accordance with the Accomplishment Instructions of
Cessna Service Letter SL680-53-05, Revision 2, dated September 30,
2015. Repeat the general visual inspection thereafter at intervals
not to exceed 100 flight hours, until the modification required by
paragraph (i) of this AD is accomplished.

(h) Repair

    If, during any inspection required by paragraph (g) of this AD,
any disbonding or cracked paint is found, before further flight,
obtain instructions approved by the Manager, Wichita Aircraft
Certification Office (ACO), ACE-118W, FAA, and, within the
compliance time specified in those instructions, accomplish the
instructions accordingly.

(i) Modification

    At the applicable compliance time specified in paragraph (i)(1)
or (i)(2) of this AD, modify the airplane by installing additional
stiffeners on the aft canted bulkhead, in accordance with the
Accomplishment Instructions of Cessna Service Bulletin SB680-53-08,
Revision 2, dated November 2, 2016, except as provided by paragraphs
(k) and (l) of this AD. Doing this modification terminates the
repetitive inspections required by paragraph (g) of this AD.
    (1) For airplanes that have accumulated 7,000 or more total
flight hours as of the effective date of this AD: Within 1,800
flight hours or 24 months, whichever occurs first, after the
effective date of this AD.
    (2) For airplanes that have accumulated less than 7,000 total
flight hours as of the effective date of this AD: Within 3,600
flight hours or 48 months, whichever occurs first, after the
effective date of this AD.

(j) Credit for Previous Actions

    (1) This paragraph provides credit for actions required by
paragraph (g) of this AD, if those actions were performed before the
effective date of this AD using Cessna Service Letter SL680-53-05,
dated December 22, 2014; or Cessna Service Letter SL680-53-05,
Revision 1, dated March 12, 2015.
    (2) This paragraph provides credit for actions required by
paragraph (i) of this AD, if those actions were performed before the
effective date of this AD using Cessna Service Bulletin SB680-53-08,
dated September 28, 2015.

(k) Exceptions to Service Information Specifications

    Although Cessna Service Bulletin SB680-53-08, Revision 2, dated
November 2, 2016, specifies using the latest revision of Drawing
6991119, this AD allows using any revision level of that drawing.

(l) Provisions Regarding Reporting

    Although Cessna Service Bulletin SB680-53-08, Revision 2, dated
November 2, 2016; and Cessna Service Letter SL680-53-05, Revision 2,
dated September 30, 2015; specify to submit certain information to
the manufacturer, this AD does not include that requirement.

(m) Special Flight Permit

    Special flight permits, as described in Section 21.197 and
Section 21.199 of the Federal Aviation Regulations (14 CFR 21.197
and 21.199), are not allowed.

(n) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Wichita ACO, ACE-118W, FAA, has the authority
to approve AMOCs for this AD, if requested using the procedures
found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your
request to your principal inspector or local Flight Standards
District Office, as appropriate. If sending information directly to
the manager of the ACO, send it to the attention of the person
identified in paragraph (o)(1) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(o) Related Information

    (1) For more information about this AD, contact Phuoc Le,
Aerospace Engineer, Airframe Branch, ACE-118W, Wichita Aircraft
Certification Office (ACO), FAA, 1801 Airport Road, Room 100, Dwight
D. Eisenhower Airport, Wichita, KS 67209; phone:<PHONE_NUMBER>; fax:
316-946-4107; email<EMAIL_ADDRESS>    (2) Service information identified in this AD that is not
incorporated by reference is

available at the addresses specified in paragraphs (p)(3) and (p)(4)
of this AD.

(p) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Cessna Service Letter SL680-53-05, Revision 2, dated
September 30, 2015.
    (ii) Cessna Service Bulletin SB680-53-08, Revision 2, dated
November 2, 2016.
    (3) For service information identified in this AD, contact
Textron Aviation Inc., P.O. Box 7706, Wichita, KS 67277; telephone
316-517-6215; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
Internet https://support.cessna.com/custsupt/csupport/newlogin.jsp.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference 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 March 16, 2017.
Dionne Palermo,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-05771 Filed 3-27-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: September 10, 2009 (Volume 74, Number 174)]
[Notices]
[Page 46614]
[DOCID:fr10se09-81]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2009-0001]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice; 30-day notice and request for comments; revision of a
currently approved information collection; OMB No. 1660-0087; No Forms.

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SUMMARY: The Federal Emergency Management Agency (FEMA) has submitted
the information collection abstracted below to the Office of Management
and Budget for review and clearance in accordance with the requirements
of the Paperwork Reduction Act of 1995. The submission describes the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and includes the actual data
collection instruments FEMA will use.

DATES: Comments must be submitted on or before October 13, 2009.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the Desk
Officer for the Department of Homeland Security, Federal Emergency
Management Agency, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Records Management Division, 1800 South Bell Street, Arlington, VA
20598-3005, facsimile number<PHONE_NUMBER>, or e-mail address FEMA-
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Collection of Information

    Title: PrepCAST (formerly NIMSCAST).
    Type of information collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0087.
    Form Titles and Numbers: No forms.
    Abstract: The PrepCAST is a standardized data collection and
assessment process that effectively assesses prevention, protection,
response, and recovery capabilities at the regional, State, local, and
Tribal levels. In the National Incident Management System collection
tool, data will be collected on the respondent's ability to meet the
established NIMS Implementation Objectives. The State Preparedness
Report collection tool will address questions about current
capabilities that have not already been answered through other
assessments and reports, focusing on level of performance of individual
activities for the 37 capabilities set forth in the Target Capabilities
List (TCL) 2.0. FEMA collects this data to guide policy and resource
allocation decisions.
    Affected Public: State, Local and Tribal Government.
    Estimated Number of Respondents: 3,982.
    Frequency of Response: Once.
    Estimated Average Hour Burden per Respondent: 6.10 hours.
    Estimated Total Annual Burden Hours: 24,278 hours.
    Estimated Cost: There is no annual reporting and recordkeeping cost
associated with this collection.

Larry Gray,
Director, Records Management Division, Office of Management, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. E9-21753 Filed 9-9-09; 8:45 am]

BILLING CODE 9111-46-P


[Federal Register Volume 85, Number 153 (Friday, August 7, 2020)]
[Proposed Rules]
[Pages 47928-47931]
[FR Doc No: 2020-17278]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0642; Airspace Docket No. 19-AWP-98]
RIN 2120-AA66

Proposed Amendment of V-25, V-27, V-494, V-108, V-301, and T-257
in the Vicinity of Santa Rosa, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend VHF Omnidirectional Range (VOR)
Federal airways V-25, V-27, V-494, V-108, V-301, and United States Area
Navigation route T-257 in the vicinity of Santa Rosa, CA. The
amendments are due to the planned decommissioning of the Santa Rosa, CA
VOR/Distance Measuring Equipment (DME) navigation aid (NAVAID) which
provides navigation guidance for portions of the affected airways. The
Santa Rosa VOR/DME is being decommissioned as part of the FAA's VOR
Minimum Operational Network (MON) program.

DATES: Comments must be received on or before September 21, 2020.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
1(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2020-0642; Airspace Docket No. 19-AWP-98 at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov.
    FAA Order 7400.11D, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Rules and Regulations Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11D at NARA, email:
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Christopher McMullin, Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    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 would modify the National Airspace System as necessary
to preserve the safe and efficient flow of air traffic.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2020-0642; Airspace Docket No. 19-AWP-98) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at https://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2020-0642; Airspace Docket No. 19-AWP-98.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Operations Support Group, Western
Service Center, Federal Aviation Administration, 2200 South 216th St.,
Des Moines, WA 98198.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11D, Airspace
Designations and Reporting Points, dated August 8, 2019, and effective
September 15, 2019. FAA Order 7400.11D is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11D lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

Background

    The FAA is planning to decommission the Santa Rosa, CA VOR/DME in
December 2020. The Santa Rosa, CA VOR/DME was one of the candidate VORs
identified for discontinuance by the FAA's VOR MON

program and listed in the Final policy statement notice, ``Provision of
Navigation Services for the Next Generation Air Transportation System
(NextGen) Transition to Performance-Based Navigation (PBN) (Plan for
Establishing a VOR Minimum Operational Network),'' published in the
Federal Register of July 26, 2016 (81 FR 48694), Docket No. FAA-2011-
1082.
    The Federal airway dependencies to the Santa Rosa, CA VOR/DME are
V-25, V-27, V-494, V-108, V-301, and T-257. With the planned
decommissioning of the Santa Rosa, CA VOR/DME, the proposed
modifications to the dependent airways would result in airway segments
supported by the Santa Rosa, CA VOR/DME being amended. The intersection
GETER will be amended utilizing radials from the Point Reyes and
Mendocino VORs. The amended intersection will slightly change the
placement by .21 Nautical Miles (NM) to the east of the current
location. A new intersection (ROZZA) will be established at the current
location and coordinates of the Santa Rosa, CA VOR/DME, and the
effected airways (V-494, V-108, and V-301) legal descriptions will be
updated to reflect the change. The new ROZZA intersection forced a
slight change to GETER since pilots only have one navigational aid
(Mendocino, CA) to navigate to ROZZA on V-494, which will also affect
the position of FREES intersection. These intersections will be
redefined and relocated, which will effect V-27, V-494, and T-257.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 to amend Federal airways V-25, V-27, V-
494, V-108, V-301, and T-257 due to the planned decommissioning of the
Santa Rosa, CA VOR/DME. The proposed Federal airway actions are
described below.
    V-25: V-25 currently extends between Mission Bay, CA and Wenatchee,
WA. The FAA proposes to amend V-25 to reflect the new description of
GETER intersection. GETER intersection will be redefined by deleting
the Santa Rosa, CA VOR/DME references and using radials from Point
Reyes and Mendocino VORs. The unaffected portions of the existing
airway would remain as charted.
    V-27: V-27 currently extends between Mission Bay, CA and Seattle,
WA. The FAA proposes to amend the description of GETER intersection to
reflect the deletion of Santa Rosa, CA references and include new
references using radials from Point Reyes, CA and Mendocino, CA VORs.
The unaffected portions of the existing airway would remain as charted.
    V-494: V-494 currently extends from Crescent City, CA to Hazen, NV.
The FAA proposes to amend the legal description by removing the
reference to the Santa Rosa, CA VOR/DME and establishing an
intersection (ROZZA) utilizing radials from Point Reyes, CA VOR/DME and
Scaggs Island, CA VOR Collocated Tactical Air Navigation System
(VORTAC). The unaffected portion of the existing airway would remain as
charted.
    V-108: V-108 currently extends from Santa Rosa, CA to Hill City,
KS. The FAA proposes to amend the route removing references to the
Santa Rosa, CA VOR/DME and referring to the newly established ROZZA
intersection utilizing radials from Point Reyes, CA VOR/DME and Scaggs
Island, CA VORTAC. The unaffected portion of the existing airway would
remain as charted.
    V-301: V-301 currently extends from Panoche, CA to Williams, CA.
The FAA proposes to amend the route, removing references to the Santa
Rosa, CA VOR/DME and referring to the newly established ROZZA
intersection utilizing radials from Point Reyes, CA VOR/DME and Scaggs
Island, CA VORTAC. The unaffected portion of the existing airway would
remain as charted.
    T-257: T-257 currently extends from Ventura, CA to Tatoosh, WA. The
FAA proposes to amend the route to reflect the amended location of
FREES due to the relocation on GETER. The unaffected portion of the
existing airway would remain as charted.
    VOR Federal airways are published in paragraph 6010(a) and United
States Area Navigation Routes are published in paragraph 6011 of FAA
Order 7400.11D dated August 8, 2019, and effective September 15, 2019,
which is incorporated by reference in 14 CFR 71.1. The ATS routes
listed in this document would be subsequently published in the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (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 proposed 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.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 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(f), 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 FAA Order 7400.11D,
Airspace Designations and Reporting Points, dated August 8, 2019, and
effective September 15, 2019, is amended as follows:

Paragraph 6010(a) Domestic VOR Federal Airways.

* * * * *

V-25 [Amended]

    From Mission Bay, CA, via Los Angeles, CA; INT Los Angeles
261[deg] and Ventura, CA, 144[deg] radials; 6 miles wide, Ventura;
San Marcus, CA; Paso Robles, CA; Salinas, CA; INT Salinas 310[deg]
and Woodside, CA, 158[deg] radials; Woodside; San Francisco, CA; INT
San Francisco 304[deg] and Point Reyes, CA, 161[deg] radials; Point
Reyes; INT Point Reyes 352[deg] (T) 335 (M) and Mendocino, CA,
146[deg] (T) 130[deg] (M) radials; 28 miles, 24 miles, 85 MSL, 18
miles, 75 MSL, Red Bluff, CA; 53 miles, 95 MSL, INT Red Bluff
015[deg] and Klamath Falls, OR, 181[deg] radials; 19 miles, 95 MSL,
Klamath Falls; 21 miles, 77 miles, 90 MSL, Deschutes, OR; Klickitat,
WA; Yakima, WA; Ellensburg, WA; Wenatchee, WA. The

airspace below 2,000 feet MSL outside the United States and the
airspace more than 3 miles NE of the airway centerline between Seal
Beach and INT of Seal Beach 287[deg] and Los Angeles 138[deg]
radials is excluded. The airspace within R-2511 and W-289 is
excluded. The airspace within R-2519 more than 3 statute miles west
of the airway centerline, and the airspace within R-2519 below 5,000
feet MSL is excluded. The portion outside the United States has no
upper limit.
* * * * *

V-27 [Amended]

    From Mission Bay, CA, INT Mission Bay 319[deg] and Santa
Catalina, CA, 099[deg] radials; Santa Catalina; 6 miles wide,
Ventura, CA; INT Ventura 326[deg] and Fillmore, CA, 265[deg]
radials; INT Fillmore 265[deg] and Gaviota, CA, 143[deg] radials;
Gaviota; Morro Bay, CA; INT Morro Bay 308[deg] and Big Sur, CA,
157[deg] radials; Big Sur; INT Big Sur 325[deg] and Point Reyes, CA,
161[deg] radials; Point Reyes; INT Point Reyes 352[deg] (T) 335[deg]
(M) and Mendocino, CA, 146[deg] (T) 130[deg] (M) radials; Mendocino;
Fortuna, CA; Crescent City, CA; 31 miles, 32 miles, 59 MSL, North
Bend, OR; Newport, OR; 39 miles, 30 miles, 45 MSL, Astoria, OR;
Hoquiam, WA; Seattle, WA. The airspace below 2,000 feet MSL outside
the United States between San Diego and Santa Catalina, the airspace
within R-2516 and W-289, the airspace within R-2519 more than 3
statute miles west of the airway centerline, and the airspace within
R-2519 below 5,000 feet MSL, is excluded. The portion outside the
United States has no upper limit.
* * * * *

V-494 [Amended]

    From Crescent City, CA, via INT Crescent City 195[deg] and
Fortuna, CA, 345[deg] radials; Fortuna; INT Fortuna 170[deg] and
Mendocino, CA 321[deg] radials,; INT Point Reyes, CA 006[deg] (T)
349[deg] (M) and Scaggs Island, CA 314[deg] (T) 297[deg] (M)
radials; Sacramento, CA; INT Sacramento 038[deg] and Squaw Valley,
CA, 249[deg] radials; Squaw Valley; INT Squaw Valley 078[deg] and
Hazen, NV, 244[deg] radials; Hazen.
* * * * *

V-108 [Amended]

    From INT Point Reyes 006[deg] (T) 349[deg] (M) and Scaggs Island
314[deg] (T) 297[deg] (M) radials, via Scaggs Island, CA; INT Scaggs
Island 131[deg]. and Concord, CA, 276[deg]. radials; 7 miles wide (4
miles N. and 3 miles S. of centerline), Concord; Linden, CA. From
Meeker, CO; via Red Table, CO; Black Forest, CO; Hugo, CO; 74 miles,
65 MSL, Goodland, KS; Hill City, KS.
* * * * *

V-301 [Amended]

    From Panoche, CA; via INT Panoche 317[deg] and Oakland, CA,
110[deg] radials; Oakland; Point Reyes, CA; INT Point Reyes 006[deg]
(T) 349[deg] (M) and Scaggs Island 314[deg] (T) 297[deg] (M);
Williams, CA.
* * * * *

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-257 Ventura, CA (VTU) to Tatoosh, WA (TOU) [Amended]
Ventura, CA (VTU)                VOR/DME            (Lat. 34[deg]06'54.21'' N, long. 119[deg]02'58.17'' W)
San Marcus, CA (RZS)             VORTAC             (Lat. 34[deg]30'34.32'' N, long. 119[deg]46'15.57'' W)
Morro Bay, CA (MQO)              VORTAC             (Lat. 35[deg]15'08.12'' N, long. 120[deg]45'34.44'' W)
BLANC, CA                        FIX                (Lat. 35[deg]37'53.19'' N, long. 121[deg]21'23.04'' W)
CAATE, CA                        WP                 (Lat. 36[deg]46'32.29'' N, long. 122[deg]04'09.57'' W)
CHAWZ, CA                        WP                 (Lat. 37[deg]06'48.59'' N, long. 122[deg]21'09.58'' W)
PORTE, CA                        NFIX               (Lat. 37[deg]29'23.23'' N, long. 122[deg]28'28.48'' W)
THHEO, CA                        WP                 (Lat. 37[deg]44'54.55'' N, long. 122[deg]36'54.79'' W)
JAMIN, CA                        WP                 (Lat. 37[deg]51'16.99'' N, long. 122[deg]40'12.05'' W)
Point Reyes, CA (PYE)            VORTAC             (Lat. 38[deg]04'47.12'' N, long. 122[deg]52'04.18'' W)
FREES, CA                        FIX                (Lat. 38[deg]23'13.59'' N, long. 122[deg]55'20.56'' W)
NACKI, CA                        WP                 (Lat. 38[deg]43'47.73'' N, long. 123[deg]05'52.93'' W)
Mendocino, CA (ENT)              VORTAC             (Lat. 39[deg]03'11.58'' N, long. 123[deg]16'27.58'' W)
FLUEN, CA                        FIX                (Lat. 39[deg]32'47.92'' N, long. 123[deg]33'42.75'' W)
PLYAT, CA                        FIX                (Lat. 40[deg]20'20.90'' N, long. 123[deg]41'35.88'' W)
CCHUK, CA                        WP                 (Lat. 40[deg]31'42.18'' N, long. 124[deg]04'16.08'' W)
SCUPY, CA                        WP                 (Lat. 40[deg]55'23.94'' N, long. 124[deg]18'09.85'' W)
OLJEK, CA                        FIX                (Lat. 41[deg]28'30.66'' N, long. 124[deg]14'20.68'' W)
CIGCA, CA                        WP                 (Lat. 41[deg]36'39.60'' N, long. 124[deg]17'27.58'' W)
FURNS, CA                        WP                 (Lat. 41[deg]55'15.86'' N, long. 124[deg]26'09.40'' W)
MITUE, OR                        FIX                (Lat. 43[deg]18'49.00'' N, long. 124[deg]30'22.74'' W)
JANAS, OR                        FIX                (Lat. 44[deg]17'33.63'' N, long. 124[deg]05'14.25'' W)
Newport, OR (ONP)                VORTAC             (Lat. 44[deg]34'31.26'' N, long. 124[deg]03'38.14'' W)
CUTEL, OR                        FIX                (Lat. 44[deg]54'27.50'' N, long. 124[deg]01'25.30'' W)
ILWAC, WA                        FIX                (Lat. 46[deg]19'46.62'' N, long. 124[deg]10'49.49'' W)
ZEDAT, WA                        FIX                (Lat. 46[deg]35'50.64'' N, long. 124[deg]10'01.14'' W)
WAVLU, WA                        FIX                (Lat. 46[deg]50'00.90'' N, long. 124[deg]06'35.70'' W)
Hoquiam, WA (HQM)                VORTAC             (Lat. 46[deg]56'49.35'' N, long. 124[deg]08'57.37'' W)
COPLS, WA                        WP                 (Lat. 47[deg]06'46.78'' N, long. 124[deg]07'40.80'' W)
WAPTO, WA                        FIX                (Lat. 47[deg]28'19.54'' N, long. 124[deg]13'50.38'' W)
OZETT, WA                        WP                 (Lat. 48[deg]03'07.00'' N, long. 124[deg]35'54.42'' W)
Tatoosh, WA (TOU)                VORTAC             (Lat. 48[deg]17'59.64'' N, long. 124[deg]37'37.36'' W)

* * * * *

    Issued in Washington, DC, on August 4, 2020.
Scott M. Rosenbloom,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2020-17278 Filed 8-6-20; 8:45 am]
BILLING CODE 4910-13-P


August __, 2008

Debra Edwards, Ph.D., Director

	Office of Pesticide Programs

Steven Bradbury, Ph.D., Director

	Special Review and Registration Division

USEPA Headquarters

1200 Pennsylvania Avenue, NW

Mail Code 7508P

Washington, DC 20460

	Re:	Chloropicrin RED  – Request for Extension of Time to Submit
Comments

Dear Dr. Edwards and Dr. Bradbury:

I am writing on behalf of grower’s of  The California Strawberry
Nurserymen’s Association  to request a 45-day extension of the comment
period on the Reregistration Eligibility Decisions (REDs) for
Chloropicrin, Dazomet, Metam Sodium and Methyl Bromide (73 Fed. Reg.
40871).  Chloropicrin and other soil fumigants are not only important,
but necessary for the successful cultivation of Nursery Strawberry
Plants ( which provides the California Strawberry Industry with plants
to replant the 30,000 acres of commercial fruit producing acreage
annually). Therefore, participation in the public comment process is
imperative for all growers.  However, since the current comment period
has occurred during one of the busiest time of year for growers, we do
not have sufficient time to review and analyze the multiple REDs and the
extensive technical support documents.   Many support documents,
including EPA’s response to previous grower comments were made
available by EPA for the first time on July 16.

In particular, as proposed, the risk mitigation plans in the REDs will
greatly impact growers by adding considerable costs for each fumigation.
 In order to fully consider the feasibility of these mitigation plans,
as well as adequate alternatives, growers must consult with registrants
and other stakeholders.  Moreover, growers use multiple soil fumigants
and must consider the overall affects of the REDs.   Growers simply do
not have sufficient opportunity to do so in the given comment period.

Growers realize that other affected groups have also requested
extensions and we join in their requests to extend the comment period by
additional 45-days.  Please call me at<PHONE_NUMBER> if you have any
questions regarding this request

Sincerely,

Bob Tipton

Strawberry Nursery Manager

Driscoll Strawberry Associates

22000 Bend Ferry Road

Red Bluff , Calif.

 PAGE   1

	-   PAGE  2  -


[Federal Register Volume 82, Number 116 (Monday, June 19, 2017)]
[Notices]
[Page 27951]
[FR Doc No: 2017-12701]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: NAS Data
Release Request

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew a previously approved
information collection. The information enables the FAA to evaluate the
validity of the user's request for National Airspace (NAS) data from
FAA systems and equipment.

DATES: Written comments should be submitted by August 18, 2017.

ADDRESSES: Send comments to the FAA at the following address: Ronda
Thompson, Federal Aviation Administration, ASP-110, 800 Independence
Ave. SW., Washington, DC 20591.

PUBLIC COMMENTS INVITED: You are asked to comment on any aspect of this
information collection, including (a) Whether the proposed collection
of information is necessary for FAA's performance; (b) the accuracy of
the estimated burden; (c) ways for FAA to enhance the quality, utility
and clarity of the information collection; and (d) ways that the burden
could be minimized without reducing the quality of the collected
information. The agency will summarize and/or include your comments in
the request for OMB's clearance of this information collection.

FOR FURTHER INFORMATION CONTACT: Ronda Thompson by email at:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0668.
    Title: NAS Data Release Request.
    Form Numbers: FAA Form 1200-5.
    Type of Review: Renewal of an information collection.
    Background: This data collection is the genesis for granting
approval to release filtered NAS data. The information provided sets
the criteria for the FAA Data Release Request Committee (DRRC) to
approve or disapprove individual requests for NAS data. The information
submitted by the requestor determines the requestor's eligibility to
use FAA NAS data. The agency currently uses the collected information
to determine suitability for procuring NAS data for use in various
evaluations.
    Respondents: Approximately 9 data requestors annually.
    Frequency: On occasion.
    Estimated Average Burden per Response: 3 hours.
    Estimated Total Annual Burden: 27 hours.

    Issued in Washington, DC, on June 5, 2017.
Ronda L. Thompson,
FAA Information Collection Clearance Officer, Performance, Policy, and
Records Management Branch, ASP-110.
[FR Doc. 2017-12701 Filed 6-16-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: December 18, 2009 (Volume 74, Number 242)]
[Notices]
[Page 67237-67238]
[DOCID:fr18de09-78]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0575]

Incorporation of New Science Into Regulatory Decisionmaking
Within the Center for Devices and Radiological Health; Public Meeting;
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

    The Food and Drug Administration (FDA) is announcing a public
meeting entitled: ``Incorporation of New Science Into Regulatory
Decisionmaking Within the Center for Devices and Radiological Health.''
The purpose of the public meeting is to identify strategies and means
for incorporating new science into the regulatory decisionmaking
process within the agency's Center for Devices and Radiological Health
(CDRH). New science may include novel technologies or novel uses of
existing technologies, evolving information and knowledge, or new
methods to support decisionmaking. FDA is seeking input on a number of
specific questions regarding how CDRH should anticipate and respond to
new or evolving scientific knowledge in a manner that is consistent
with our mission to protect and promote the public health, and requests
comments on this topic.
    Dates and Time: The public workshop will be held on February 9,
2010, from 8 a.m. to 5 p.m. Persons interested in attending the meeting
must register by 5 p.m. on February 3, 2010.
    Location: The public meeting will be held at the Hilton Washington
DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877.
    Contact Person: Maggie Dietrich, Food and Drug Administration,
Center for Devices and Radiological Health, 10903 New Hampshire Ave.,
Bldg. 66, rm. 5449, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX:
301-847-8510, e-mail<EMAIL_ADDRESS>    Registration: Register online at http://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/default.htm (select the appropriate
meeting from the list). Provide complete contact information for each
attendee, including name, title, affiliation, address, e-mail, and
telephone number. Registration requests should be received by February
3, 2010. Registration is free and will be on a first-come, first-served
basis. Early registration is recommended because seating is limited.
FDA may limit the number of participants from each organization based
on space limitations. Registrants will receive confirmation once they
have been accepted. Onsite registration on the day of the public
meeting will be provided on a space-available basis beginning at 7 a.m.
    If you need special accommodations due to a disability, please
contact Maggie Dietrich (see Contact Person) at least 7 days in
advance.
    Comments: FDA is holding this public meeting to obtain information
on a number of specific questions regarding how CDRH should anticipate
and respond to new or evolving scientific knowledge in a manner that is
consistent with FDA's mission to protect and promote the public health.
The deadline for submitting comments regarding this public meeting is
February 24, 2010.
    Regardless of attendance at the public meeting, interested persons
may submit written or electronic comments. Submit written comments to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://www.regulations.gov. Submit a
single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments
are to be identified with the docket number found in brackets in the
heading of this document. Please also indicate the specific question(s)
addressed. (See section II 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.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA's CDRH uses science to guide our regulatory decisions,
including those related to premarket approval or clearance, postmarket
oversight, and compliance.
    CDRH faces unique challenges in that the products we regulate are
constantly changing, either through incremental or disruptive advances.
Simultaneously, our understanding of the products we oversee is subject
to change as we obtain new scientific information or develop new
methods to assess existing data.
    Given the ever-changing environment in which we operate, CDRH's
regulatory decisionmaking process must be able to adapt as science
evolves and as new information emerges about the risks or benefits of
particular medical devices or radiation-emitting electronic products.
For example, in some cases, new information gathered about the risk-
benefit profile of a device on the market may justify requiring
additional data on similar types of devices during premarket review, in
order to provide sufficient confidence in the product's safety and
effectiveness. At the same time, the center seeks to foster innovation
by providing industry with a reasonable degree of predictability in our
regulatory pathways. Determining the optimal way to anticipate and
respond to new science is an important challenge, and the center seeks
public input on how to best address it.
    CDRH has formed an internal Task Force on Utilization of New
Science in Regulatory Decisionmaking to review how the center uses
science in our regulatory decisionmaking process, and to make
recommendations for enhancements. The principal goals of the Task Force
are: (1) To propose systems that will allow CDRH to be ``predictably
adaptive'' to new science; and (2) to identify proactive steps that
CDRH can take to keep staff abreast of new science and increase our
technical competence and analytic capability in order to enhance our
decisionmaking.
    The notion of ``predictable adaptability'' refers to having the
flexibility to appropriately respond to changes in science, while doing
so through a reasonably consistent process. Given that scientific
knowledge is continually changing, the model of being ``predictable''
by always requiring the same type and level of scientific evidence to
justify decisions will not necessarily suffice. As the scientific
landscape changes, the kind of information we need in order to make
well-supported decisions may change. In the past, CDRH has sometimes
incorporated new science into our regulatory decisionmaking on an ad
hoc, non-transparent basis. Such an approach can result in inconsistent
regulatory expectations and less predictable decisionmaking.
    CDRH seeks to move toward a different model of predictability:
Creating and adhering to clear procedures for adapting to new science,
and applying a consistent rationale for doing so in as timely and
transparent a manner as is appropriate and feasible. In order to
achieve this goal, the center

will need to identify how and when to adapt to new science, with a full
consideration of the nature of the science itself, public health
implications, and our statutory and regulatory framework.

II. Public Meeting

    As one step towards establishing the center's approach for
incorporating new science in regulatory decisionmaking, CDRH will hold
a public meeting to discuss the issues the Task Force is considering.
The objective of the meeting will be to hear input on these issues from
a broad range of external constituencies, including industry
representatives, consumer and patient advocates, academic experts,
other members of Government, and the general public.
    To focus the center's strategies, CDRH requests feedback related to
the following questions, which will serve as the basis for discussion
at the public meeting:

A. Adapting to New Scientific Information

    (1) When CDRH gains new scientific information about a particular
product or type of product, what should the criteria be for changing
CDRH's expectations of the evidence necessary for pre- or postmarket
regulatory decisions, keeping in mind our mission to protect and
promote the public health, as well as our statutory and regulatory
framework? What are potential ``triggers'' for making such changes?
    (2) When such changes are warranted, how should the center
communicate them to industry, consumers, and other external
constituencies? Should CDRH have a new regulatory paradigm for
communicating with outside parties?
    (3) When such changes are warranted, how should CDRH apply them to
devices currently under review?
    (4) When such changes are warranted, how should CDRH apply them to
products currently on the market? For example, how should CDRH treat
``first-generation'' products as new and improved versions are
developed?

B. Adapting to Novel Technologies or Novel Uses of Existing
Technologies

    (1) Assessing the safety and effectiveness of a novel technology
can be challenging because the extent of information on and the level
of understanding of the technology's risk-benefit profile or
manufacturing process is less mature than that of a technology for
which there is extensive ``real-world'' experience. What steps should
CDRH take to assure that novel technologies or novel uses of existing
technologies are safe and effective, without creating barriers to
innovation, keeping in mind our statutory and regulatory framework?

C. Enhancing CDRH's Technical Competence and Analytical Capability

    (1) With current resources, what proactive steps should CDRH take
to address gaps in staff-members' knowledge about new science and
reduce uncertainty in science-based regulatory decisionmaking?
    During the meeting, there will be a moderated discussion between
CDRH staff and invited experts from the private and public sectors
about the questions presented in this document. The invited
participants will not be asked to develop consensus recommendations,
but rather to provide their individual perspectives. The topics for
discussion will be presented in conjunction with hypothetical case
studies for consideration. There will also be an opportunity for
general attendees to provide feedback on the discussion topics during
periodic open sessions.
    In advance of the meeting, additional information, including the
case studies, will be made available on the Internet. This information
will be placed on file in the public docket (docket number found in
brackets in the heading of this document), which is available at http:/
/www.regulations.gov. This information will also be available on FDA's
Medical Devices Web site at http://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/default.htm (select the appropriate
meeting from the list), along with the agenda for the meeting.
    Transcripts: Transcripts of the public meeting may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 15 working days after the public meeting at a cost of 10
cents per page. A transcript of the public meeting will be available on
the Internet at http://www.regulations.gov.

    Dated: December 11, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-30114 Filed 12-17-09; 8:45 am]

BILLING CODE 4160-01-S


Cooling Water Intake Structure ( CWIS) Information Data Required Rig Information Rig Name Galaxy 1 Glomar High Island 1 Galaxy 2 Glomar High Island 2 Galaxy 3 Glomar High Island 4 Magellan Rig 127 Monarch Rig 134 Monitor Rig 136 Rig Type Jackup F& G L780 or equivalent Jackup Total Installed Power Generation Capacity 8800 HP Number of Cooling Water Intake Structures ( CWISs) 4 Deepwell pumps Brief description of each CWIS ( e. g., sea chest, simple pipe) 16" Tower pump riser into 12" pipe 5 Rigs with 20" preload caisson for water intake Rough dimensions of each CWIS and indicate whether onboard CWIS has an existing flange 16" opening no flange 5 Rigs with Prelaod pumps with 20" open pipe w/ out flange Screen type ( e. g., strainer, wedge wire) with mesh size Basket Strainers on deck.

Total Design Specifications for Daily Maximum Water Intake Volume of each CWIS 2.0 million gal ( 48,000 bbls) 5 Rigs have Preload pump 5,500 gpm Total Daily Water Intake Volume of each CWIS ( Set up/ Drilling) 2.0 million gal ( 48,000 bbls)

Design Specs for Through Screen Velocity of each CWIS ( i. e., Q= V* A) ( Set up/ Drilling) Velocity of regular submersible pumps = 2.23 ft/ sec Velocity of Preload pump 6.1 ft/ sec ( 5 rigs only) List of Purposes of Cooling Water Intakes ( e. g., cool crude oil, produced water, power generators, drill pipe brakes) Watermaker heat exchangers, fuel oil heat exchangers, mudpump heat exchangers, air handling units List of Purposes of Non cooling Water Intakes ( e. g., fire water, hotel loads) Watermaker, Fire Main, Ballast, Sanitary, Pits,

Total Volume of Water Intake for Ballasting, Duration of the Ballast intake, and the Through Screen Velocity of the Ballast intake 2.5 million gal ( 20,000 kips) 6 10 hours, see above Mitigation Measures for reducing Exotic Species Migration through Ballast water The rigs do not carry much ballast water from location to location; it is generally taken on and dumped at the same location. Mitigation Measures for reducing Impingement and Entrainment of Aquatic Organisms, as well as Bio fouling Prevention Measures Strainers Is the Rig equipped with a Radiator Cooling System for the Main Engines? Radiator closed loop cooling system


Multiple commenters (0131, 0193, and 0242) opposed the imposition of an additional annual short-term performance test. Commenter 0193 argued that the imposition of a short-term annual test, in addition to a 12-month rolling average standard, would add no significant value sufficient to offset the increased cost and uncertainty created by the test. Commenter 0192 stated that New NGCC units can readily meet EPA's proposed emission standards for new units when operating at ideal conditions, specifically when first installed in a new and clean condition, operating at baseload and corrected to standardized conditions. Commenter 0193 stated that the challenge is in consideration of the 12-month rolling average that encompasses all possible operating scenarios encountered by a real world operating facility. Commenter 0193 stated that establishing a short-term annual test would impose additional regulatory burden with no associated benefit in the form of emission reductions.
Commenter 0131 noted that the rolling average was developed specifically to provide an averaging due to conditions like part load and heavy load (optimum) operation. Commenter 0131 stated that adding an additional short test period does little to provide usable data or verification, and that owners will generally seek to make sure their machines are operated and installed using best practice. The commenter stated that EPA should recognize that best practice is necessary to optimize performance both operationally and economically--the latter driver is the most important one.
Commenter 0242 also disagreed with the need for a short term compliance test. Commenter 0242 was not sure whether EPA was suggesting that a more stringent standard than those proposed could later be set based on a short term compliance test, or whether EPA was proposing to set a short term limit based on the compliance test. Commenter 0242 questioned whether EPA considered that these units will not always be able to operate at their most efficient short term rate. Commenter 0242 stated that If EPA continued forward with this proposal, and so few sources would be affected as EPA suggested, then states should be able to set the limitation at a level that would account for different operating conditions; it should be the state's responsibility to set those limits based on each unit's unique circumstances. Commenter 0242 was not in agreement with short-term requirements being imposed under this proposal. Commenter 0242 stated that the proposal addresses CO2 emissions for which there is no basis or reasoning for requiring any short-term requirements to limit emissions and provides no logic as to why short-term limits in addition to long-term limits will address climate change
Commenter 0212 disagreed with EPA on establishing a separate standard for load-following (i.e., intermediate capacity factor) NGCC EGUs. The commenter stated that the more stringent standard that EPA is considering would apply only during periods of high annual capacity factors, and a less stringent standard would apply during periods of intermediate load (e.g., when electric sales are between 33 to 60 percent of the potential electric output). The commenter believes that an initial performance test combined with an on-going performance standard (hybrid approach) would be far simpler to implement and enforce than this approach. The commenter believes this issue highlights one of the key advantages of a hybrid approach. The commenter stated that there is far less uncertainty regarding the performance of a new NGCC facility operating at full load under ISO conditions versus an older facility operating at variable load conditions. The commenter stated that in some cases, fast start and hot restart capability can result in a slightly lower base load efficiency; however, the effect is modest and would not prevent a facility designed for base-load and load-following operation from achieving a standard between 900-950 lb/MWh. The commenter stated that by establishing an initial performance standard (consistent with EPA's BSER determination), EPA will ensure that companies invest in the high-efficiency generating technologies, which in turn, reduces the burden on the on-going performance standard to accommodate different levels of cycling and intermediate load conditions. The commenter stated that the on-going performance standard can be set at a level (like 1,100 lb/MWh) that is reasonably achievable under a wide range of operating conditions, while still relying on the initial performance test to drive the best technology choice. The commenter stated that the alternative approach that EPA is suggesting, with separate standards for different operating conditions, could have the unintended consequence of encouraging less efficient technologies and less efficient operation.
While in concept an initial performance test in conjunction with an on-going continuous compliance standard appears appealing, the EPA disagrees that is it appropriate for the final rule. The universe of NGCC units covered by the base load subcategory includes fast-start NGCC units and NGCC units designed for steady state base load operation. An initial performance test based on the performance of the latter would preclude the use of fast-start NGCC units even though, in their intended role of frequent starting, stopping, and cycling, their actual performance may be superior to a NGCC unit designed for steady state operation.
7.2.3 Load Following/Intermediate vs. Base Load Standard
Commenters 0187 and 0203 supported EPA's proposed approach to establish separate standards for load-following NGCC EGUs.   Commenter 0187 also believes that modified combustion turbines and modified boilers fall into this category.  Commenters 0187 and 0203 stated that this approach would apply a more stringent standard during periods of high capacity factors and a less stringent standard during periods of intermediate capacity factors (e.g., 33 to 60%). Commenter 0187 noted that many boilers that used to be base-loaded are now load-following at times. Commenter 0187 stated that load factor has a significant impact on unit heat rate and the efficiency of units will be less than in the baseline period when they were base-loaded.
Commenter 0193 stated that EPA was correct to examine whether a separate standard should be established for load-following (i.e., intermediate capacity factor) NGCC EGUs, but was concerned about its implementation and enforcement. The commenter stated that the more stringent standard would apply only during periods of high annual capacity factors and a less stringent standard would apply during periods of intermediate load (e.g., when electric sales are between 33 to 60 percent of the potential electric output). The commenter stated that this approach addresses two potential issues with the standards in the January 2014 proposal:
(1)  certain NGCC units are designed to be highly efficient when operated as load-following units, but these design characteristics reduce the efficiency at base load. Conversely, the NGCC units with the highest base load design efficiencies are not necessarily as efficient as NGCC designed and intended to be used as load-following EGUs. Therefore, a full-load efficiency performance test would not necessarily result in the lowest CO2 emissions in practice.
(2) NGCC units operating as load-following EGUs are inherently less efficient than NGCC units operating at base load. Establishing a standard that varies with load would assure that NGCC units that are operated as base load units are as efficient as possible and still account for inherent lower efficiencies at part-load conditions.
The commenter noted that gas turbine installations that operate at base-load would generally demonstrate a higher 12-month average efficiency (i.e. lower CO2/MWh emission rate) than load-following installations that operate between 33 and 60 percent capacity factor on average when considering the broader range of operational conditions the intermediate/load following plant would experience during the 12-month averaging period. The commenter stated that in soliciting comments on this proposal, EPA recognized the difficulty of establishing a one-size-fits-all standard for combustion turbines that are increasingly being designed and purchased for different power needs. While the commenter supported EPA's exploration of this issue, the commenter remained concerned that a load-following standard would be difficult to implement and enforce, as annual capacity factors would likely vary significantly from year to year, and in fact would quite possibly vary from month to month as the 12-month average is recalculated on a 30-day basis. The commenter stated that this uncertainty for purchasers, operators and regulators may diminish the value of a load-following standard.

Commenter 0195 generally supported EPA's proposed approach to set a separate standard for load-following (i.e., intermediate capacity factor) NGCC units, but the commenter also had some concerns. The commenter cited the preamble discussion in the proposal, that a more stringent standard would apply only during periods of high annual capacity factors and a less stringent limit would apply during periods of intermediate load. The commenter stated that EPA explained that this approach would address the fact that when NGCC units are designed to be load-following units, these design characteristics will impede efficient operation at base load and vice versa, and that NGCC units operating as load-following EGUs are not as efficient as base load NGCC units and thus approach would address this situation. On a conceptual level, the commenter stated that a flexible standard that accounts for varying efficiencies due to how the units are operated is appropriate and reasonable. The commenter felt there was not sufficient specificity in the current proposal on how a flexible standard would work in practice for load-following units. The commenter stated that EPA needs to conduct a supplemental rulemaking to provide more detail on this type of standard so that industry can provide meaningful input.
Commenters 0213 and 0232 noted that EPA crafted the modified/reconstructed rule proposal so as to exclude units that operate in peaking mode and argued there is no basis in law or policy to exempt units from regulation simply because they operate less frequently (and hence less efficiently). The commenters stated that section 111(b) expressly permits EPA to create different emission limits for different kinds of units within a given regulatory category ("The Administrator may distinguish among classes, types, and sizes within categories of new sources for the purpose of establishing such standards"). The commenters stated that rather than simply exempting units from regulation on the basis of how frequently they run over the course of a calendar year or on a three-year rolling average basis, the Agency should cover all sources that supply (or are designed to supply) any amount of electricity to the grid, and should distinguish among these sources on a functional basis. The commenters, therefore, proposed the same three-tiered regulatory model for modified and reconstructed stationary combustion turbines that they discussed in their comments on the new source standard, which recommends that EPA recognize three subcategories of NGCC facilities--baseload, load-following/intermediate, and peaking EGUs--and establish the following separate performance standards for each:
 Peaking units (defined as affected EGUs that operate less than 1200 hours per year) would be subject to a net output-based emission limit of 1,100 lb CO2/MWh.
 Intermediate/load-following units (defined as EGUs that operate between 1,200 and 4,000 hours annually) would be subject to a net output-based emission limit of 875 lb CO2/MWh.
 Baseload units (defined as EGUs that operate over 4,000 hours annually) would be subject to a net output-based emission limit of 825 lb CO2/MWh.
The commenters stated that the recommended standards are based on the reported performance of NGCC units in each of these subcategories and are entirely achievable and well within a reasonable cost range given the technology that is currently available, and modified and reconstructed units should be required to meet them. The commenters referred to their comments on the proposed carbon pollution standards for new EGUs. See: EPA-HQ-OAR-2013-0495-9514.
Commenter 0215 stated that EPA has acknowledged that CO2 emissions increase at lower loads, so in principle this might diminish the number of units that cannot meet the Agency's proposed NSPS for both reconstructed and modified NGCC units. The commenter stated that EPA adopted a similar approach, for similar reasons, in its NSPS for NOx for Subpart KKKK units, setting the standard for operations at peak load (100 percent of the manufacturer's design capacity of the combustion turbine at ISO conditions). The commenter stated that EPA's suggested approach (as well as the similar approach that EPA used in establishing the NSPS for NOx for NGCC Subpart KKKK units) results in "little advantage..." [See Smith Turbine Report at 5].
The final applicability criteria included in the final rule include all new and reconstructed combustion turbines regardless of actual electric sales. The EPA has finalized standards accommodating base load and non-base load operation. The BSER for base load units has been identified as NGCC. The BSER for non-base load units has been identified as clean fuels. Whether or not a unit is one category or the other is based on the amount of electricity sold to the grid, derived from a unit's nameplate design efficiency calculated as a percentage of potential electric output.
Commenters 0142 and 0242 suggested that if the EPA establishes separate standards for load-following NGCC units, the EPA should also establish separate standards for coal-fired EGUs based upon how they are dispatched. Both commenters noted that for gas turbines, the EPA is soliciting comment on whether a separate standard should be established for load-following (i.e. intermediate capacity factor) NGCC EGUs, where the more stringent standard would apply only during periods of high annual capacity factors and a less stringent standard would apply during intermediate load periods (e.g., when electric sales are between 33 to 60% of potential electric output). The commenters stated that this would address the fact that certain NGCC are designed to be highly efficient when operated as load-following units, but due to the design characteristics efficiency is reduced at base load (and vice-versa). The commenters stated that NGCC units operating as load-following are inherently less efficient than base load units. The commenters agreed that EPA is correct that a unit's dispatch will affect its emissions but argued that these concepts are true for most fossil-fuel fired generators, not just NGCC units. Commenter 0242 found it difficult to rationalize why such considerations would potentially be given to natural gas units and not coal-fired boilers. Commenter 0242 found it particularly perplexing when they understood that some coal-fired units may have to trigger the "modify" or "reconstruct" definition to achieve compliance with section 111(d) requirements.
The EPA disagrees that tiered emission standards are appropriate for coal-fired EGUs. Coal-fired units, unlike natural gas-fired units, have the option to burn fuels with lower CO2 emission rates. The use of natural gas or distillate oil would reduce the emission rate of a coal-fired EGU by approximately 40 to 20 percent respectively. The use of either of these fuels would more than offset any increase in the emission rate that results from operating at part-load conditions. A further difference is that stationary combustion turbines include two distinct technology choices, simple cycle and NGCC technology, with different emission profiles and operating characteristics. This was a factor in determining a separate BSER for non-base load and base load units.