[Federal Register Volume 78, Number 72 (Monday, April 15, 2013)]
[Proposed Rules]
[Pages 22215-22218]
[FR Doc No: 2013-08768]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0326; Directorate Identifier 2012-NM-089-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to supersede an existing airworthiness directive
(AD) that applies to certain The Boeing Company Model 757 series
airplanes equipped with Rolls-Royce RB211 engines. The existing AD
currently requires modification of the nacelle strut and wing
structure; for certain airplanes, repetitive detailed inspections of
certain aft bulkhead fasteners for loose or missing fasteners, and
corrective action if necessary. For certain other airplanes, the
existing AD requires a one-time detailed inspection of the middle
gusset of the inboard side load fitting for proper alignment, and
realignment if necessary; a one-time eddy current inspection of certain
fastener holes for cracking, and repair if necessary; a detailed
inspection of certain fasteners for loose or missing fasteners; and
replacement with new fasteners if necessary. Since we issued that AD, a
compliance time error was discovered, which could allow an airplane to
exceed the acceptable compliance time for addressing the unsafe
condition. This proposed AD would specify a maximum compliance time
limit. We are proposing this AD to prevent fatigue cracking in primary
strut structure and consequent reduced structural integrity of the
strut.

DATES: We must receive comments on this proposed AD by May 30, 2013.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Boeing
Commercial Airplanes, Attention: Data & Services Management, P.O. Box
3707, MC 2H-65, Seattle, WA 98124-2207; phone:<PHONE_NUMBER>, extension
1; fax:<PHONE_NUMBER>; Internet: https://www.myboeingfleet.com. You may
review copies of the 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 425-
227-1221.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (phone:<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Nancy Marsh, Aerospace Engineer,
Airframe Branch, ANM-120S, Seattle Aircraft Certification Office (ACO),
FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2013-0326;
Directorate Identifier 2012-NM-089-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On May 25, 2004, we issued AD 2004-12-07, Amendment 39-13666 (69 FR
33561, June 16, 2004), for certain Model 757 series airplanes equipped
with Rolls-Royce RB211 engines. (AD 2004-12-07 superseded AD 99-24-07,
Amendment 39-11431 (64 FR 66370, November 26, 1999)). AD 2004-12-07
requires modification of the nacelle strut and wing structure; and for
certain airplanes, repetitive detailed inspections of certain aft
bulkhead fasteners for loose or missing fasteners, and corrective
action if necessary. For certain other airplanes, the existing AD
requires a one-time detailed inspection of the middle gusset of the
inboard side load fitting for proper alignment and realignment if
necessary; a one-time eddy current inspection of certain fastener holes
for cracking, and repair if necessary; a detailed inspection of certain
fasteners for loose or missing fasteners; and replacement with new
fasteners if necessary. That AD resulted from reports indicating that
the actual operational loads applied to the nacelle are higher than the
analytical loads that were used during the initial design. Such an
increase in loading can lead to fatigue cracking in primary strut

structure prior to an airplane reaching its design service objective.
We issued that AD to prevent fatigue cracking in primary strut
structure and consequent reduced structural integrity of the strut.

Actions Since Existing AD Was Issued

    Since we issued AD 2004-12-07, Amendment 39-13666 (69 FR 33561,
June 16, 2004), a compliance time error was discovered in certain
service information related to the AD. The error involves an optional
threshold formula that could allow an airplane to exceed the acceptable
compliance time for addressing the unsafe condition.
    We reviewed Boeing Service Bulletin 757-54-0035, Revision 6, dated
December 2, 2011. For information on the procedures and compliance
times, see this service information at http://www.regulations.gov by
searching for Docket No. FAA-2013-0326.

Concurrent Service Information

    Boeing Service Bulletin 757-54-0035, Revision 6, dated December 2,
2011, specifies concurrent or prior accomplishment of Boeing Service
Bulletin 757-54-0003, Revision 1, dated August 30, 1985; and Boeing
Service Bulletin 757-54-0028, Revision 1, dated August 25, 1994. For
information on the procedures, see this service information at http://www.regulations.gov by searching for Docket No. FAA-2013-0326.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously, except as discussed
under ``Differences Between the Proposed AD and the Service
Information.''
    The phrase ``related investigative actions'' might be used in this
proposed AD. ``Related investigative actions'' are follow-on actions
that: (1) Are related to the primary actions, and (2) are actions that
further investigate the nature of any condition found. Related
investigative actions in an AD could include, for example, inspections.
    In addition, the phrase ``corrective actions'' might be used in
this proposed AD. ``Corrective actions'' are actions that correct or
address any condition found. Corrective actions in an AD could include,
for example, repairs.

Change to Existing AD

    This proposed AD would retain certain requirements of AD 2004-12-
07, Amendment 39-13666 (69 FR 33561, June 16, 2004). Since AD 2004-12-
07 was issued, the AD format has been revised, and certain paragraphs
have been rearranged. As a result, the corresponding paragraph
identifiers have changed in this proposed AD, as listed in the
following table:

                      Revised Paragraph Identifiers
------------------------------------------------------------------------
    Requirement in AD  2004-12-07,
  Amendment  39-13666  (69 FR 33561,   Corresponding requirement in this
            June 16, 2004)                        proposed AD
------------------------------------------------------------------------
paragraph (a)........................  paragraph (g)
paragraph (c)........................  paragraph (h)
------------------------------------------------------------------------

Differences Between the Proposed AD and the Service Information

    Boeing Service Bulletin 757-54-0035, Revision 6, dated December 2,
2011; and Boeing Service Bulletin 757-54-0028, Revision 1, dated August
25, 1994; specify to contact the manufacturer for instructions on how
to repair certain conditions, but this proposed AD would require
repairing those conditions in one of the following ways:
     In accordance with a method that we approve; or
     Using data that meet the certification basis of the
airplane, and that have been approved by the Boeing Commercial
Airplanes Organization Designation Authorization (ODA) whom we have
authorized to make those findings.

Costs of Compliance

    We estimate that this proposed AD affects 176 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
            Action                   Labor cost        Parts cost    Cost per product    Cost on U.S.  operators
----------------------------------------------------------------------------------------------------------------
Modification [retained actions  Up to 1,188 work-              $0  Up to $100,980        Up to $17,772,480
 from AD 2004-12-07, Amendment   hours x $85 per
 39-13666 (69 FR 33561, June     hour = $100,980.
 16, 2004)].
One-time Inspection [retained   1 work-hour x $85               0  $85                   $14,960
 action from AD 2004-12-07,      per hour = $85.
 Amendment 39-13666 (69 FR
 33561, June 16, 2004)].
Concurrent modification [new    142 work-hours x $85            0  $12,070               $362,100
 proposed action, 30             per hour = $12,070.
 airplanes].
Concurrent inspection and       104 work-hours x $85            0  $8,840                $106,080
 fastener installation [new      per hour = $8,840.
 proposed action, 12
 airplanes].
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this proposed
AD.
    According to the manufacturer, some of the costs of this proposed
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

    We have 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 above, I certify that the 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, 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.

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 removing airworthiness directive (AD)
2004-12-07, Amendment 39-13666 (69 FR 33561, June 16, 2004), and adding
the following new AD:

The Boeing Company: Docket No. FAA-2013-0326; Directorate Identifier
2012-NM-089-AD.

(a) Comments Due Date

    The FAA must receive comments on this AD action by May 30, 2013.

(b) Affected ADs

    This AD supersedes AD 2004-12-07, Amendment 39-13666 (69 FR
33561, June 16, 2004).

(c) Applicability

    This AD applies to The Boeing Company Model 757-200, -200PF, and
-200CB series airplanes, certificated in any category, line numbers
1 through 735 inclusive, equipped with Rolls-Royce RB211 engines.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 54, Nacelles/Pylons.

(e) Unsafe Condition

    This AD was prompted by reports indicating that the actual
operational loads applied to the nacelle are higher than the
analytical loads that were used during the initial design. We are
issuing this AD to prevent fatigue cracking in primary strut
structure and consequent reduced structural integrity of the strut.

(f) Compliance

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

(g) Retained Modification

    This paragraph restates the requirements of paragraph (a) of AD
2004-12-07, Amendment 39-13666 (69 FR 33561, June 16, 2004) with new
service information. Modify the nacelle strut and wing structure
according to Boeing Service Bulletin 757-54-0035, dated July 17,
1997; Revision 1, dated April 15, 1999; Revision 2, dated June 13,
2002; or Revision 6, dated December 2, 2011; at the later of the
times specified in paragraph (g)(1) or (g)(2) of this AD, except as
required by paragraph (i) of this AD. All of the terminating actions
described in the service bulletins and listed in paragraph I.C.,
Table I, ''Strut Improvement Bulletins,'' on page 6 of Boeing
Service Bulletin 757-54-0035, dated July 17, 1997; on page 7 of
Boeing Service Bulletin 757-54-0035, Revision 1, dated April 15,
1999; and on Page 7 of Boeing Service Bulletin 757-54-0035, Revision
2, dated June 13, 2002; as applicable; must be accomplished
according to those service bulletins prior to, or concurrently with,
the accomplishment of the modification of the nacelle strut and wing
structure required by this paragraph. After July 21, 2004 (the
effective date of AD 2004-12-07), use only Boeing Service Bulletin
757-54-0035, Revision 2, dated June 13, 2002; or Boeing Service
Bulletin 757-54-0035, Revision 6, dated December 2, 2011. After the
effective date of this AD, use only Boeing Service Bulletin 757-54-
0035, Revision 6, dated December 2, 2011. Accomplishment of the
actions required by paragraph (i) of this AD terminates the
requirements of this paragraph.
    (1) Prior to the accumulation of 37,500 total flight cycles, or
prior to 20 years since the date of manufacture of the airplane,
whichever occurs first.
    (2) Within 3,000 flight cycles after January 3, 2000 (the
effective date of AD 99-24-07, Amendment 39-11431 (64 FR 66370,
November 26, 1999)).

(h) Retained Inspection and Repair

    This paragraph restates the requirements of paragraph (c) of AD
2004-12-07, Amendment 39-13666 (69 FR 33561, June 16, 2004), with
new service information. For airplanes on which the modification
required by paragraph (g) of this AD has been done according to
Boeing Service Bulletin 757-54-0035, dated July 17, 1997: Within
15,000 flight cycles after doing the modification required by
paragraph (g) of this AD, or within 3 years after July 21, 2004 (the
effective date of AD 2004-12-07), whichever is later; do a one-time
detailed inspection of the middle gusset of the inboard side load
fitting for proper alignment, according to Part II of the
Accomplishment Instructions of Boeing Service Bulletin 757-54-0035,
Revision 1, dated April 15, 1999; or Revision 2, dated June 13,
2002, excluding Evaluation Form; or Boeing Service Bulletin 757-54-
0035, Revision 6, dated December 2, 2011. If the gusset is not
aligned properly: Before further flight, machine the gusset to the
specified angle according to the Accomplishment Instructions of
Boeing Service Bulletin 757-54-0035, Revision 1, dated April 15,
1999; or Revision 2, dated June 13, 2002, excluding Evaluation Form;
or Boeing Service Bulletin 757-54-0035, Revision 6, dated December
2, 2011. As of the effective date of this AD, use only Boeing
Service Bulletin 757-54-0035, Revision 6, dated December 2, 2011,
for accomplishing the actions required by this paragraph.

(i) New Compliance Time Limitation

    For airplanes on which the modification of the nacelle strut and
wing structure required by paragraph (g) of this AD has not been
done as of the effective date of this AD: Do the modification
required by paragraph (g) of this AD at the later of the times
specified in paragraphs (i)(1) and (i)(2) of this AD.
    (1) At the time specified in paragraph 1.E., ``Compliance,'' of
Boeing Service Bulletin 757-54-0035, Revision 6, dated December 2,
2011, except that where this service bulletin specifies a compliance
time ``from the date on Revision 4 of this service bulletin,'' this
AD requires compliance within the specified compliance time after
the effective date of this AD.
    (2) Within 3,000 flight cycles after January 3, 2000 (the
effective date of AD 99-24-07, Amendment 39-11431 (64 FR 66370,
November 26, 1999)).

(j) New Concurrent Actions

    Concurrently with or prior to the accomplishment of the actions
required by paragraph (i) of this AD, do the actions specified in
paragraphs (j)(1) and (j)(2) of this AD.
    (1) For airplanes identified in Boeing Service Bulletin 757-54-
0003, dated Revision 1, dated August 30, 1985: Modify the nacelle
strut upper spar, in accordance with the Accomplishment Instructions
of Boeing Service Bulletin 757-54-0003, Revision 1, dated August 30,
1985.
    (2) For airplanes identified in Boeing Service Bulletin 757-54-
0028, Revision 1, dated August 25, 1994: Do a detailed inspection
and non-destructive test inspection for cracking of the lower chord,
mid-chord, and holes (for cracking, galling, corrosion, or damage
due to fastener removal), in accordance with the Accomplishment
Instructions of Boeing Service Bulletin 757-54-0028, Revision 1,
dated August 25, 1994.

(k) Repair

    (1) If any cracking is found during any inspection required by
paragraph (j)(2) of this AD: Before further flight, repair the
cracking using a method approved in accordance with the procedures
specified in paragraph (m) of this AD.
    (2) If any holes with galling, corrosion, or damage due to
fastener removal are found during any inspection required by
paragraph (j)(2) of this AD: Before further flight, repair the
holes, in accordance with the Accomplishment Instructions of Boeing
Service Bulletin 757-54-0028, Revision 1, dated August 25, 1994.

(l) Credit for Previous Actions

    (1) This paragraph provides credit for the actions required by
paragraph (g) of this AD, if those actions were performed before the
effective date of this AD using Boeing Service Bulletin 757-54-0035,
Revision 4, dated June 18, 2009; or Revision 5, dated June 9, 2011;
which are not incorporated by reference in this AD.
    (2) This paragraph provides credit for the actions required by
paragraph (h) of this AD, if those actions were performed before the
effective date of this AD using Boeing Service Bulletin 757-54-0035,
Revision 4, dated June 18, 2009; or Revision 5, dated June 9, 2011;
which are not incorporated by reference in this AD.
    (3) This paragraph provides credit for the actions required by
paragraph (j) of this AD, if those actions were performed before the
effective date of this AD using Boeing Service Bulletin 757-54-0003,
dated December 14, 1984; or Boeing Service Bulletin 757-54-0028,
dated March 31, 1994; which are not incorporated by reference in
this AD.

(m) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Certification Office (ACO), 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 the Related Information section of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO, to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane and the approval must
specifically refer to this AD.
    (4) AMOCs approved for AD 2004-12-07, Amendment 39-13666 (69 FR
33561, June 16, 2004), are approved as AMOCs for paragraphs (g) and
(h) of this AD, except for AMOCs that approved a revised compliance
time.

(n) Related Information

    (1) For more information about this AD, contact Nancy Marsh,
Aerospace Engineer, Airframe Branch, ANM-120S, Seattle Aircraft
Certification Office (ACO), FAA, 1601 Lind Avenue SW., Renton, WA
98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; phone: 206-544-
5000, extension 1; fax:<PHONE_NUMBER>; Internet: https://www.myboeingfleet.com. You may review copies of the 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>.

    Issued in Renton, Washington, on April 4, 2013.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-08768 Filed 4-12-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: November 14, 2007 (Volume 72, Number 219)]
[Proposed Rules]
[Page 64008-64009]
[DOCID:fr14no07-20]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-29335; Directorate Identifier 2007-NM-045-AD]
RIN 2120-AA64

Airworthiness Directives; McDonnell Douglas Model DC-9-81 (MD-
81), DC-9-82 (MD-82), DC-9-83 (MD-83), DC-9-87 (MD-87), and MD-88
Airplanes

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

ACTION: Notice of proposed rulemaking (NPRM); extension of comment
period.

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SUMMARY: This document extends the comment period for the above-
referenced NPRM, which proposes the adoption of a new airworthiness
directive (AD) that applies to all McDonnell Douglas Model DC-9-81 (MD-
81), DC-9-82 (MD-82), DC-9-83 (MD-83), DC-9-87 (MD-87), and MD-88
airplanes. The NPRM would require repetitive inspections for cracking
of the overwing frames from stations 845 to 905 (MD-87 stations 731 to
791), left and right sides, and corrective actions if necessary. The
NPRM results from reports of cracked overwing frames. This extension of
the comment period is necessary to ensure that all interested persons
have ample opportunity to submit any written relevant data, views, or
arguments regarding the NPRM.

DATES: We must receive comments on this NPRM by December 3, 2007.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov.
 Follow the instructions for submitting comments.

     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

    For service information identified in this AD, contact Boeing
Commercial Airplanes, Long Beach Division, 3855 Lakewood Boulevard,
Long Beach, California 90846, Attention: Data and Service Management,
Dept. C1-L5A (D800-0024).

FOR FURTHER INFORMATION CONTACT: Roger Durbin, Aerospace Engineer,
Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification
Office, 3960 Paramount Boulevard, Lakewood, California 90712-4137;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: We proposed to amend 14 CFR part 39 with a
notice of proposed rulemaking (NPRM) for an AD (the ``original NPRM'')
for all McDonnell Douglas Model DC-9-81 (MD-81), DC-9-82 (MD-82), DC-9-
83 (MD-83), DC-9-87 (MD-87), and MD-88 airplanes. The original NPRM was
published in the Federal Register on September 28, 2007 (72 FR 55111).
The original NPRM proposed to require repetitive inspections for
cracking of the overwing frames from stations 845 to 905 (MD-87
stations 731 to 791), left and right sides, and corrective actions if
necessary. The original NPRM also invites comments on its overall
regulatory, economic, environmental, and energy aspects.

Events Leading to Extension of Comment Period

    Since we issued the NPRM, the DOT's Docket Management System (DMS)
was replaced by the Federal Docket Management System (FDMS). FDMS is a
government-wide, electronic docket management system, which contains
the public dockets and is the method used for submitting comments on
the overall regulatory, economic, environmental, and energy aspects of
proposed rulemaking actions. However, due to the service disruption
caused by the transition from DOT's DMS to the FDMS, the docket
material was not posted on the FDMS until November 1, 2007. Therefore,
we have determined that the public was not provided adequate
opportunity to submit comments on the NPRM. As a result, we have
decided to extend the comment period for this NPRM until December 3,
2007, to receive additional comments.

FAA's Determination

    We have considered this issue and find it appropriate to extend the
comment period to give all interested persons additional time to
examine the proposed requirements of the original NPRM and submit
comments. After evaluating the circumstances stated previously, we have
determined that extending the comment period until December 3, 2007,
will not compromise the safety of these airplanes.

Extension of Comment Period

    The comment period for Docket No. FAA-2007-29335; Directorate
Identifier 2007-NM-045-AD; has been revised. The comment period now
closes December 3, 2007.
    No other part of the regulatory information has been changed;
therefore, the original NPRM is not republished in the Federal
Register.

    Issued in Renton, Washington, on November 7, 2007.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 07-5654 Filed 11-9-07; 10:10 am]

BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 223 (Monday, November 19, 2012)]
[Notices]
[Pages 69449-69450]
[FR Doc No: 2012-28011]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP13-12-000]

Gulf South Pipeline Company, LP; Notice of Request Under Blanket
Authorization

    Take notice that on November 1, 2012, Gulf South Pipeline Company,
LP (Gulf South), 9 Greenway Plaza, Suite 2800, Houston, TX 77046, filed
in Docket No. CP13-12-000, an application pursuant to sections
157.205(b), 157.208(c), 157.210 and 157.216 of the Commission's
Regulations under the Natural Gas Act (NGA) as amended, to construct
certain facilities at its Rodrigue Compressor Station and to abandon in
place an idled compressor unit at its Napoleonville Compressor Station
in Assumption Parish, Louisiana, under Gulf South's blanket certificate
issued in Docket No. CP82-430-000, all as more fully set forth in the
application which is on file with the Commission and open to public
inspection. Gulf South is proposing these modifications in order to
provide transportation service to Entergy Louisiana, LLC's Ninemile
Power Plant in Assumption Parish, Louisiana. The filing may also be
viewed on the web at http://www.ferc.gov using the ``eLibrary'' link.
Enter the docket number excluding the last three digits in the docket
number field to access the document. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>or toll free at (866)
208-3676, or TTY, contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to
Michael E. McMahon, Senior Vice President and General Counsel, J. Kyle
Stephens, Vice President, Regulatory Affairs or M.L. Gutierrez,
Director, Regulatory Affairs, Boardwalk Pipeline Partners, LP, 9
Greenway Plaza, Suite 2800, Houston, TX 77046 at telephone (713) 479-
8252, fax<PHONE_NUMBER> or email<EMAIL_ADDRESS>
<EMAIL_ADDRESS>or<EMAIL_ADDRESS>    Any person or the Commission's staff may, within 60 days after
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and pursuant to Section 157.205 of
the regulations under the NGA (18 CFR 157.205), a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed

activity shall be deemed to be authorized effective the day after the
time allowed for filing a protest. If a protest is filed and not
withdrawn within 30 days after the allowed time for filing a protest,
the instant request shall be treated as an application for
authorization pursuant to Section 7 of the NGA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commentary, will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 7 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.

    Dated: November 13, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-28011 Filed 11-16-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: December 14, 2006 (Volume 71, Number 240)]
[Rules and Regulations]
[Page 75117-75121]
[DOCID:fr14de06-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 60 and 62

[OAR; FRL-8255-9]

Notice of Finding That Certain States Did Not Submit Clean Air
Mercury Rule (CAMR) State Plans for New and Existing Electric Utility
Steam Generating Units and Status of Submission of Such Plans

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: In this action, EPA is making a finding on the status of
submission of State Plans in response to the Clean Air Mercury Rule
(CAMR). CAMR requires States to develop plans for implementing a phased
cap on mercury emissions from new and existing large, coal-fired
electric generating units leading to nationwide reductions in mercury
emissions from such units and establishes November 17, 2006 as the
deadline for submitting those plans. At present, some States have
submitted plans, others are still in the process of developing plans,
and some are choosing not to submit plans but instead to allow a
Federal Plan addressing such emissions to go into effect in that State.

    In this action, EPA is making specific findings that certain States
did not submit CAMR State Plans by the November 17, 2006 deadline and
is otherwise providing notice of the status of State Plan submissions.
In conjunction with this rule, EPA is also providing letters to each
State regarding this action.

DATES: Effective Date: The effective date of this rule is December 14,
2006.

FOR FURTHER INFORMATION CONTACT: Mr. Murat Kavlak, U.S. Environmental
Protection Agency,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: For questions related to a specific State,
please contact the appropriate regional office:

------------------------------------------------------------------------
               Regional offices                    States and tribes
------------------------------------------------------------------------
Dave Conroy, Acting Branch Chief, Air          Connecticut, Maine,
 Programs Branch, EPA New England, I Congress   Massachusetts, New
 Street, Suite 1100, Boston, MA 02114-2023,     Hampshire, Rhode Island,
<PHONE_NUMBER>.                                and Vermont.
Raymond Werner, Chief, Air Programs Branch,    New Jersey, New York,
 EPA Region 2, 290 Broadway, 25th Floor, New    Puerto Rico, and Virgin
 York, NY 10007-1866,<PHONE_NUMBER>.           Islands.
Dave Campbell, Chief, Permits and Technical    Delaware, District of
 Assessment Branch, EPA Region 3, 1650 Arch     Columbia, Maryland,
 Street, Philadelphia, PA 19103-2187, (215)     Pennsylvania, Virginia,
 814-2196.                                      and West Virginia.
Dr. Kenneth Mitchell, Chief, Air Toxics        Alabama, Florida,
 Assessment and Implementation Section, EPA     Georgia, Kentucky,
 Region 4, Sam Nun Atlanta Federal Center, 61   Mississippi, North
 Forsyth Street, SW, 12th Floor, Atlanta, GA    Carolina, South
 30303-8960,<PHONE_NUMBER>.                    Carolina, and Tennessee.
Carl Nash, Chief, Integrated Air Toxics        Illinois, Indiana,
 Section, EPA Region 5, 77 West Jackson         Michigan, Minnesota,
 Street, Chicago, IL 60604,<PHONE_NUMBER>.     Ohio, and Wisconsin.
Rebecca Weber, Branch Chief, EPA Region 6,     Arkansas, Louisiana, New
 1445 Ross Avenue, Dallas, TX 75202, (214)      Mexico, Oklahoma, and
 665-6656.                                      Texas.
Michael Jay, Air Programs Branch, EPA Region   Iowa, Kansas, Missouri,
 7, 901 North 5th Street, Kansas City, Kansas   and Nebraska.
 66101-2907,<PHONE_NUMBER>.
Richard R. Long, Director, Air and Radiation   Colorado, Montana, North
 Program, EPA Region 8, 999 18th Street,        Dakota, South Dakota,
 Suite 300, Denver, CO 80202,<PHONE_NUMBER>.   Utah, and Wyoming.
Andrew Steckel, Chief, Rules Office, EPA       Arizona, California,
 Region 9, 75 Hawthorne Street, San             Guam, Hawaii, and
 Francisco, CA 94105,<PHONE_NUMBER>.           Nevada.
Mahbubul Islam, Manager, State and Tribal Air  Alaska, Idaho, Oregon,
 Programs, EPA Region 10, Office of Air,        and Washington.
 Waste, and Toxics, Mail Code OAQ-107, 1200
 Sixth Avenue, Seattle, WA 98101, (206) 553-
 6985.
------------------------------------------------------------------------

Table of Contents:

I. Background
II. This Action
III. Statutory and Executive Order Reviews
    A. Notice and Comment Under the Administrative Procedures Act
    B. Executive Order 12866: Regulatory Planning and Review
    C. Paperwork Reduction Act
    D. Regulatory Flexibility Act
    E. Unfunded Mandates Reform Act
    F. Executive Order 13132: Federalism
    G. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    H. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
    I. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    J. National Technology Transfer Advancement Act
    K. Congressional Review Act
    L. Judicial Review

I. Background

    On March 15, 2005, EPA finalized CAMR and established standards of
performance for reducing mercury emissions from new and existing coal-
fired electric generating units (EGUs) (70 FR 28606, May 18, 2005).
CAMR was revised on June 9, 2006 (71 FR 33388, June 9, 2006). CAMR
affects 53 jurisdictions, including the 50 States, the District of
Columbia, and 2 Tribes, and requires State Plan submissions by these
jurisdictions, except for the 2 Tribes. (The States and the District of
Columbia are generally referred to in this notice as ``States''.) CAMR
requires each State to submit a State Plan containing provisions that
ensure that the State's applicable annual EGU mercury emissions budget
is not exceeded. In choosing a mechanism for meeting the applicable
State budget, States are free to choose the mechanism that best suits
the particular State's needs, so long as that mechanism ensures that
the State budget is not exceeded. CAMR also established a nationwide,
EPA-administered cap-and-trade program that affected jurisdictions may
choose to adopt in order to achieve the required reductions.
    The mercury reductions are required under CAMR in two phases. The
first phase will cap nationwide annual EGU mercury emissions at 38 tons
beginning in 2010. The first phase cap reflects ``co-benefit''
reductions, i.e., mercury reductions that will result from reductions
of sulfur dioxide (SO2) and nitrogen oxides (NOX)
emissions under the Clean Air Interstate Rule (CAIR), issued on May 12,
2005 and revised on April 28, 2006. Because of incentives for early
emission reductions under CAMR, mercury emissions are projected to be
below the cap level in 2010. The second phase commences in 2018 and
will limit nationwide annual EGU mercury emissions to 15 tons upon full
implementation. Under CAMR, coal-fired EGUs that commence construction
starting on or after January 30, 2004 will have to meet new source
performance standards, in addition to being subject to the CAMR
emission caps.
    CAMR requires States to submit State Plans to EPA by November 17,
2006 (40 CFR 60.24(h)(2)). The rule provides each State with
flexibility to achieve the required mercury emission reductions in a
manner chosen by the State and provides a model mercury trading rule
that a State may choose to adopt to achieve the reductions. Section
60.24(h)(1) in CAMR lists the States required to submit CAMR State
Plans (70 FR 28649-50).

Status of Submission of State Plans

    EPA acknowledges and appreciates the extensive effort that States
have undertaken to develop CAMR State Plans as quickly as possible. In
particular, EPA acknowledges that certain States (listed below) have
submitted State Plans in response to CAMR by the November 17, 2006,
deadline. (EPA intends to treat State Plans as being timely submitted
as long as the plan is postmarked November 17, 2006 or earlier,
regardless of when it is actually received. As a result, it is possible
that one or more of the States not listed below did in fact submit a
State Plan by November 17, 2006 that

EPA has not yet received. If this is the case, EPA will notify each
State in question of that fact and will withdraw today's finding that
the State did not submit the required State Plan by November 17, 2006.)
EPA is now reviewing these plans. EPA also recognizes that additional
States that did not submit CAMR State Plans by November 17, 2006 are,
nevertheless, making substantial efforts to complete and submit State
Plans. EPA encourages continuation of these efforts and will continue
to assist States as they develop their plans. EPA looks forward to
receiving these State Plans in the relatively near future, will give
full consideration to all State Plans, and will approve those plans
that meet the criteria specified in CAMR and subpart B of 40 CFR part
60, regardless of when the plan is submitted.
    EPA also believes that some States may choose Federal
implementation of CAMR and, therefore, do not intend to submit a State
Plan. This may be advantageous for States with limited resources. EPA
believes that it is appropriate for States to determine whether it is
more effective to develop their own plans or to decide to allow Federal
implementation of the required mercury emission reductions. EPA fully
supports either approach. There are no sanctions that apply to States
that choose Federal implementation of CAMR. EPA will continue to work
with States that have not yet submitted State Plans to meet the
requirements in CAMR and wish to submit such a plan.
    Under 40 CFR 60.27(b), the Administrator must approve or disapprove
State Plans within 4 months of the November 17, 2006 submission
deadline. Moreover, under 40 CFR 60.27(c), the Administrator must
propose a Federal Plan for States that did not submit State Plans by
the submission deadline or whose State Plans the Administrator
disapproves. Within 6 months of the submission deadline, the
Administrator must finalize a Federal Plan for such States under 40 CFR
60.27(d), unless in the meantime the State submits a State Plan that
the Administrator determines to be approvable. Consistent with the
regulation, EPA is proposing a Federal Plan in a separate action and
intends to then proceed with promulgating a final Federal Plan. The
final Federal Plan will only apply in those States that have not
submitted a State Plan, whose State Plan submitted by November 17, 2006
has been disapproved by EPA as of the date of promulgation of the final
Federal Plan, or whose State Plan submitted after November 17, 2006 has
not been approved as of the date of promulgation of the final Federal
Plan. The final Federal Plan will not apply in States that have
submitted a State Plan by November 17, 2006 on which EPA has not taken
final action. EPA intends to review any submitted State Plans as
expeditiously as practicable. Even if EPA finalizes a Federal Plan for
a State, it is EPA's intention to work quickly to review any State Plan
or revision of a State Plan submitted by the State so that an
approvable State Plan can take the place of the Federal Plan as quickly
as possible.
    EPA's administrative efforts for CAMR will be similar to those
occurring for CAIR in that the Agency wants to work with States to
implement the program using mechanisms chosen by the States (for States
choosing to implement the programs), while also guaranteeing the public
that in a timely manner all coal-fired EGUs will be covered by the CAMR
requirements, including emissions monitoring that begins in 2009 and
the annual emissions cap that starts in 2010. EPA intends to propose a
CAMR Federal Plan with provisions that provide administrative
flexibility to States, similar to the flexibility provided in the CAIR
Federal Implementation Plan (FIP) (see 71 FR 25328, April 28, 2006).

II. This Action

    By this action, EPA is, in accordance with sections 110(c) and
111(d)(2) of the CAA and 40 CFR 60.27(c)(1), making a finding that
certain States did not submit a CAMR State Plan by November 17, 2006,
as required by CAMR. CAMR covers the States listed in 40 CFR
60.24(h)(1). The following States submitted CAMR State Plans as of the
November 17, 2006, deadline: Alabama, Arizona, Connecticut, Delaware,
Idaho, Illinois, Iowa, Louisiana, Massachusetts, Montana, Nevada, New
Hampshire, New Jersey, New York, North Dakota, Pennsylvania, Rhode
Island, South Dakota, Texas, Vermont, and West Virginia. No other
States subject to CAMR submitted CAMR State Plans by the November 17,
2006 deadline. As to those States that did not submit CAMR State Plans,
EPA finds, in accordance with CAA sections 110(c) and 111(d)(2) and 40
CFR 60.27(c)(1), that each such State did not submit a State Plan by
the November 17, 2006 deadline. Recognizing that many States that did
not submit CAMR State Plans by November 17, 2006 are making substantial
efforts to complete and submit their State Plans, EPA encourages
continuation of these efforts and looks forward to receiving and
reviewing those State Plans. As discussed above, EPA is proposing a
Federal Plan in a separate action.

III. Statutory and Executive Order Reviews

A. Notice and Comment Under the Administrative Procedures Act

    This is a final EPA action, but is not subject to notice-and-
comment requirements of the Administrative Procedures Act (APA), 5
U.S.C. 553(b). The EPA invokes, consistent with past practice, the good
cause exception pursuant to APA, 5 U.S.C. 553(b)(3)(B). Notice and
comment are unnecessary because no significant EPA judgment is involved
in finding that certain States did not submit a State Plan by the
November 17, 2006 deadline specified in CAMR and providing notice of
the status of submission of State Plans. In addition, EPA believes that
providing notice and an opportunity to comment would be contrary to the
public interest in that the finding is a necessary predicate to EPA
proposing a Federal Plan that will ultimately ensure that emission
reductions are achieved in areas not covered by an approved State Plan
and EPA needs to proceed promptly with proposing a Federal Plan to
ensure that the Federal Plan can be finalized in a timely manner.

B. Executive Order 12866: Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and
is therefore not subject to review under the EO.
    This final rule simply identifies those States that did not submit
a CAMR State Plan and provides notice of the status of State Plan
submissions in response to CAMR, therefore, EPA did not prepare an
analysis of the potential costs and benefits associated with this
action.

C. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501, et seq.
This rule relates to the requirement in CAMR for States to submit State
Plans. The present final rule simply identifies those States that did
not submit a CAMR State Plan by the November 17, 2006 deadline
specified in CAMR and, otherwise, provides notice of the status of
State Plan submissions and does not establish any new information
collection requirement. Burden means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal agency.

This includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information. An Agency may not conduct or sponsor, and a person is not
required to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in the Code of Federal Regulations (CFR) are listed in 40
CFR part 9.

D. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedures Act (APA) or any other statute unless the EPA certifies that
the rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For the purpose of assessing the impacts of today's final rule on
small entities, small entity is defined as: (1) A small business that
is a small industry entity as defined in the U.S. Small Business
Administration (SBA) size standards (see 13 CFR 121.201); (2) a small
governmental jurisdiction that is a government of a city, county, town,
school district or special district with a population of less than
50,000; and (3) a small organization that is any not-for-profit
enterprise which independently owned and operated is not dominate in
its field.
    Courts have interpreted the RFA to require a regulatory flexibility
analysis only when small entities will be subject to the requirements
of the rule. See Michigan v. EPA, 213 F.3d 663, 668-69 (D.C. Cir.,
2000), cert. den., 532 U.S. 903 (2001). The present final rule simply
identifies those States that did not submit a CAMR State Plan by the
November 17, 2006 deadline specified in CAMR and, otherwise, provides
notice of the status of State Plan submissions and does not establish
requirements applicable to small entities. After considering the
economic impacts of today's final rule on small entities, I certify
that this rule will not have a significant economic impact on a
substantial number of small entities.

E. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub.
L. 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, or Tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, or Tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and adopt
the least costly, most cost-effective, or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective, or least burdensome alternative if the
Administrator publishes with the final rule an explanation of why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including Tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.
    This action does not include a Federal mandate within the meaning
of UMRA that may result in expenditures of $100 million or more in any
1 year by either State, local, or Tribal governments in the aggregate
or to the private sector and, therefore, is not subject to the
requirements of sections 202 and 205 of the UMRA. It does not create
any additional requirements beyond those of CAMR. Therefore, no UMRA
analysis is needed. The present final rule simply identifies those
States that did not submit a CAMR State Plan by the November 17, 2006
deadline specified in CAMR and, otherwise, provides notice of the
status of State Plan submissions in response to CAMR.
    Inasmuch as this action simply provides notice of the status of
State submissions in response to pre-existing requirements under CAMR,
EPA has determined that this action contains no regulatory requirements
that might significantly or uniquely affect small governments.

F. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, or the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
    This final rule does not have federalism implications. It will not
have substantial direct effects 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,
as specified in Executive Order 13132. The Clean Air Act (CAA)
establishes the scheme whereby States take the lead in developing plans
to meet the standards of performance for new and existing sources. This
rule will not modify the relationship of the States and EPA for
purposes of developing programs to implement the standards. In
addition, this rule does not impose any new obligations on the States.
Thus, Executive Order 13132 does not apply to this rule.

G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by Tribal officials in the development of regulatory
policies that have Tribal implications.'' This final rule does not have
``Tribal implications'' as specified in Executive Order 13175. The
present final rule simply identifies those States that did not submit a
CAMR State Plan by the November 17, 2006 deadline specified in CAMR
and, otherwise,

provides notice of the status of State Plan submissions in response to
CAMR. The Tribal Authority Rule (TAR) gives Tribes the opportunity to
develop and implement CAA programs, but it leaves to the discretion of
the Tribe whether to develop these programs and which programs, or
appropriate elements of a program, the Tribe will adopt. Moreover, the
present final rule does not have a substantial direct effect on one or
more Indian Tribes, because no Tribe has implemented an air quality
management program related to the standards of performance for new and
existing EGUs under CAMR at this time.
    Furthermore, this rule does not affect the relationship or
distribution of power and responsibilities between the Federal
government and Indian Tribes. The CAA and the TAR establish the
relationship of the Federal government and Tribes in developing plans
to implement the standards of performance for new and existing EGUs,
and this rule does nothing to modify that relationship. Because this
rule does not have Tribal implications, Executive Order 13175 does not
apply.

H. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    Executive Order 13045: ``Protection of Children from Environmental
Health and Safety Risks'' (62 FR 19885, April 23, 1997) applies to any
rule that (1) is determined to be ``economically significant'' as
defined under Executive Order 12866, and (2) concerns an environmental
health and safety risk that EPA has reason to believe may have a
disproportionate effect on children. If the regulatory action meets
both criteria, EPA must evaluate the environmental health or safety
effects of the planned rule on children and explain why the planned
regulation is preferable to other potentially effective and reasonably
feasible alternatives considered by EPA. This action is not subject to
Executive Order 13045 because it is not economically significant as
defined in Executive Order 12866 and because EPA does not have reason
to believe that the environmental health risks or safety risks
addressed by this action present a disproportionate risk or safety risk
to children.

I. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, ``Actions that
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001), because it is not a significant regulatory action
under Executive Order 12866. The present final rule simply identifies
those States that did not submit a CAMR State Plan by the November 17,
2006 deadline specified in CAMR and, otherwise, provides notice of the
status of State Plan submissions in response to CAMR.

J. National Technology Transfer Advancement Act

    Section 12(d) of the National Technology Transfer Advancement Act
of 1995 (NTTAA), Public Law No. 104-113, section 12(d) (15 U.S.C. 272
note), directs EPA to use voluntary consensus standards (VCS) in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impracticable. Voluntary consensus
standards are technical standards (e.g., materials specifications, test
methods, sampling procedures, and business practices) that are
developed or adopted by VCS bodies. The NTTAA directs EPA to provide
Congress, through OMB, explanations when EPA decides not to use
available and applicable VCS.
    This action does not involve technical standards. Therefore, EPA
did not consider the use of any VCS.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801, et seq., as added by
the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the Agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. This action is not a ``major rule'' as
defined by the 5 U.S.C. 804(2). This rule will be effective upon
promulgation. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register.

L. Judicial Review

    Section 307 (b)(1) of the CAA indicates which Federal Courts of
Appeal have jurisdiction and are the appropriate venue for filing
petitions of review of final actions by EPA. This section provides, in
part, that petitions for review must be filed in the Court of Appeals
for the District of Columbia Circuit: (i) When the EPA action consists
of ``nationally applicable regulations promulgated, or final actions
taken, by the Administrator;'' or (ii) when such action is locally or
regionally applicable, if ``such action is based on a determination of
nationwide scope or effect and if in taking such action the
Administrator finds and publishes that such action is based on such a
determination.''
    This action identifying those States that did not submit a CAMR
State Plan by the November 17, 2006 deadline specified in CAMR and,
otherwise, providing notice of the status of State Plan submissions in
response to CAMR is ``nationally applicable'' within the meaning of
section 307(b)(1). For the same reasons, the Administrator also is
determining that notice of the status of submission of CAMR State Plans
is based on a determination of nationwide scope and effect for the
purposes of section 307(b)(1). This is particularly appropriate because
in the report on the 1977 Amendments that revised section 307(b)(1) of
the CAA, Congress noted that the Administrator's determination that an
action is of ``nationwide scope or effect'' would be appropriate for
any action that has ``scope or effect beyond a single judicial
circuit.'' H.R. Rep. No. 95-294 at 323, 324, reprinted in 1977
U.S.C.C.A.N. 1402-03. Here, the scope and effect of this rulemaking
extends to numerous judicial circuits since the findings and notice of
the status of submission of CAMR State Plans apply to all areas of the
country. In these circumstances, section 307(b)(1) and its legislative
history call for the Administrator to find the rule to be of
``nationwide scope or effect'' and for venue to be in the D.C. Circuit.
Thus, any petitions for review of this action related to the present
final rule must be filed in the Court of Appeals for the District of
Columbia Circuit within 60 days from the date final action is published
in the Federal Register.

List of Subjects in 40 CFR Parts 60 and 62

    Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations.

    Dated: December 7, 2006.
Stephen L. Johnson,
Administrator.
[FR Doc. E6-21283 Filed 12-13-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Rules and Regulations]
[Pages 48552-48555]
[FR Doc No: 2018-20968]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0289; FRL-9983-05]

Maltodextrin-Vinyl Pyrrolidinone Copolymer; Exemption From the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of maltodextrin-vinyl pyrrolidinone
copolymer (CAS Reg. No. 1323833-56-2) when used as an inert ingredient
in a pesticide chemical formulation. Akzo Nobel Surface Chemistry, LLC
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of maltodextrin-vinyl pyrrolidinone
copolymer on food or feed commodities.

DATES: This regulation is effective September 26, 2018. Objections and
requests for hearings must be received on or before November 26, 2018,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2018-0289, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can i get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. Can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2018-0289 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
November 26, 2018. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2018-0289, by one of
the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.

Do not submit electronically any information you consider to be CBI or
other information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of August 14, 2018 (83 FR 40272) (FRL-9981-
10), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the receipt of a pesticide petition (PP IN-11127)
filed by Akzo Nobel Surface Chemistry, LLC, 203 Dogwood Trail,
Magnolia, TX 77354. The petition requested that 40 CFR 180.960 be
amended by establishing an exemption from the requirement of a
tolerance for residues of maltodextrin-vinyl pyrrolidinone copolymer
(CAS Reg. No. 1323833-56-2). That document included a summary of the
petition prepared by the petitioner and solicited comments on the
petitioner's request. The Agency did not receive any comments.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and use in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing an exemption from the
requirement of a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue . . .'' and
specifies factors EPA is to consider in establishing an exemption.

III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no appreciable risks to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. In the case of certain chemical substances that
are defined as polymers, the Agency has established a set of criteria
to identify categories of polymers expected to present minimal or no
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the
exclusion criteria for identifying these low-risk polymers are
described in 40 CFR 723.250(d). Maltodextrin-vinyl pyrrolidinone
copolymer conforms to the definition of a polymer given in 40 CFR
723.250(b) and meets the following criteria that are used to identify
low-risk polymers.
    1. The polymer is not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
    2. The polymer does contain as an integral part of its composition
the atomic elements carbon, hydrogen, and oxygen.
    3. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
    4. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize.
    5. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.
    6. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 daltons.
    Additionally, the polymer also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
    7. The polymer's number average MW of 21,000 is greater than or
equal to 10,000 daltons. The polymer contains less than 2% oligomeric
material below MW 500 and less than 5% oligomeric material below MW
1,000.
    Thus, maltodextrin-vinyl pyrrolidinone copolymer meets the criteria
for a polymer to be considered low risk under 40 CFR 723.250. Based on
its conformance to the criteria in this unit, no mammalian toxicity is
anticipated from dietary, inhalation, or dermal exposure to
maltodextrin-vinyl pyrrolidinone copolymer.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this
exemption, EPA considered that maltodextrin-vinyl pyrrolidinone
copolymer could be present in all raw and processed agricultural
commodities and drinking water, and that non-occupational non-dietary
exposure was possible. The minimum number average MW of maltodextrin-
vinyl pyrrolidinone copolymer is 21,000 daltons. Generally, a polymer
of this size would be poorly absorbed through the intact
gastrointestinal tract or through intact human skin. Since
maltodextrin-vinyl pyrrolidinone copolymer conform to the criteria that
identify a low-risk polymer, there are no concerns for risks associated
with any potential exposure scenarios that are reasonably foreseeable.
The Agency has determined that a tolerance is not necessary to protect
the public health.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA has not found maltodextrin-vinyl pyrrolidinone copolymer to
share a common mechanism of toxicity with any other substances, and
maltodextrin-

vinyl pyrrolidinone copolymer does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that maltodextrin-vinyl
pyrrolidinone copolymer does not have a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's website at
http://www.epa.gov/pesticides/cumulative.

VI. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. Due to the expected low toxicity of maltodextrin-vinyl
pyrrolidinone copolymer, EPA has not used a safety factor analysis to
assess the risk. For the same reasons the additional tenfold safety
factor is unnecessary.

VII. Determination of Safety

    Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of maltodextrin-vinyl pyrrolidinone
copolymer.

VIII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for maltodextrin-vinyl
pyrrolidinone copolymer.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of maltodextrin-
vinyl pyrrolidinone copolymer from the requirement of a tolerance will
be safe.

X. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

XI. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: September 7, 2018.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
 1. The authority citation for part 180 continues to read as follows:

     Authority: 21 U.S.C. 321(q), 346a and 371.

0
 2. In Sec.  180.960, add alphabetically the polymer ``Maltodextrin-
vinyl pyrrolidinone copolymer, minimum number average molecular weight
(in amu), 21,000'' to the table to read as follows:

Sec.  180.960  Polymers; exemptions from the requirement of a
tolerance.

* * * * *

------------------------------------------------------------------------
                         Polymer                              CAS No.
------------------------------------------------------------------------

                              * * * * * * *
Maltodextrin-vinyl pyrrolidinone copolymer, minimum         1323833-56-2
 number average molecular weight (in amu), 21,000.......

                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2018-20968 Filed 9-25-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 69 (Tuesday, April 10, 2018)]
[Notices]
[Page 15381]
[FR Doc No: 2018-07282]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ID-8392-000]

Harris, Marcus M.; Notice of Filing

    Take notice that on April 4, 2018, Marcus M. Harris, submitted for
filing, an application for authority to hold interlocking positions,
pursuant to section 305(b) of the Federal Power Act, 16 U.S.C. 825d(b),
part 45 of the Federal Energy Regulatory Commission's (Commission)
Rules of Practice and Procedure, 18 CFR part 45, and Order Nos. 664.\1\
---------------------------------------------------------------------------

    \1\ Commission Authorization to Hold Interlocking Positions, 112
FERC 61,298 (2005) (Order No. 664); order on reh'g, 114 FERC 61,142
(2006) (Order No. 664-A).
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    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
eLibrary link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
[email protected], or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on April 25, 2018.

    Dated: April 4, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-07282 Filed 4-9-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: March 23, 2010 (Volume 75, Number 55)]
[Notices]
[Page 13766-13767]
[DOCID:fr23mr10-69]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0201] (formerly Docket No. 2007D-0118)

Guidance for Industry on the Content and Format of the Dosage and
Administration Section of Labeling for Human Prescription Drug and
Biological Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Dosage and
Administration Section of Labeling for Human Prescription Drug and
Biological Products--Content and Format.'' This guidance is one of a
series of guidance documents intended to assist applicants in drafting
prescription drug labeling in which prescribing information is clear
and accessible and in complying with the requirements in the final rule
on the content and format of labeling for

prescription drug and biological products. This guidance is intended to
help applicants select information for inclusion in the ``Dosage and
Administration'' section of labeling and to help them organize that
information.

DATES:  Submit written or electronic comments on agency guidances at
any time.

ADDRESSES:  Submit written requests for single copies of this 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 the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448. The guidance may
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. Send two self-addressed adhesive labels to assist the office in
processing your requests. Submit written comments on the guidance 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. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.

FOR FURTHER INFORMATION CONTACT: Joseph P. Griffin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4204, Silver Spring, MD 20993-0002, 301-
796-2270; or
    Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Dosage and Administration Section of Labeling for Human
Prescription Drug and Biological Products--Content and Format.'' The
guidance provides recommendations on how to select information for
inclusion in the ``Dosage and Administration'' section of labeling and
how to organize information within the section. This guidance is one of
a series of guidances FDA is developing, or has developed, to assist
applicants with the format and content of certain sections of the
labeling for prescription drugs. In the Federal Register of January 24,
2006 (71 FR 3998), FDA issued final guidances on the format and content
of the ``Adverse Reactions'' and ``Clinical Studies'' sections of
labeling and draft guidances on implementing the new labeling
requirements for prescription drugs and the format and content of the
``Warnings and Precautions,'' ``Contraindications,'' and ``Boxed
Warning'' sections of labeling. In the Federal Register of March 3,
2009 (74 FR 9250), FDA issued a draft guidance on the format and
content of the ``Clinical Pharmacology'' section of labeling. The
labeling requirements (71 FR 3922) and these guidances are intended to
make information in prescription drug labeling easier for health care
practitioners to access, read, and use.
    On April 9, 2007, FDA issued a draft of this guidance on the dosage
and administration section of labeling to obtain public comment (72 FR
17561). FDA received 10 comments--9 from the pharmaceutical industry
(individual companies, a trade association, and a consultant) and 1
from an academic medical center. The comments offered generally
favorable impressions of the guidance and its goals. The bulk of the
comments focused on clarifications and further illustrations of issues
discussed in individual sections and subsections of the guidance. FDA
made an effort to address as many of the identified concerns as
possible. A recurring general concern in many industry comments was
that the guidance should more clearly differentiate content that is
required when relevant to a given drug from content that is
recommended. FDA has attempted to make the distinction as clear as
possible by using the word ``must'' and citing the relevant section of
the regulation whenever the guidance is discussing required content and
using the word ``should'' when discussing recommended content.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on the content and format of the ``Dosage and
Administration'' section of labeling for human prescription drug and
biological products. 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.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
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. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 201.57 have been approved under
OMB control number 0910-0572.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.regulations.gov.

    Dated: March 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6322 Filed 3-22-10; 8:45 am]
BILLING CODE 4160-01-S