[Federal Register Volume 77, Number 179 (Friday, September 14, 2012)]
[Notices]
[Page 56839]
[FR Doc No: 2012-22677]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER12-2545-000]

GenOn Marsh Landing, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding,
of GenOn Marsh Landing, LLC's application for market-based rate
authority, with an accompanying rate schedule, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability is September 20, 2012.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding(s) are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 31, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-22677 Filed 9-13-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Rules and Regulations]
[Pages 56563-56566]
[FR Doc No: 2022-19902]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-1168; Project Identifier AD-2021-00825-T;
Amendment 39-22138; AD 2022-16-09]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain The Boeing Company Model 737-8 airplanes. This AD was prompted
by a report that, during production, a small number of fasteners in
certain locations of the center fuel tank were cap sealed on top of a
black stripe of ink with a clear overcoat. This clear overcoat is not
an approved surface for sealing and can potentially compromise sealant
adhesion. Compromised sealant adhesion can, over time, affect the
lightning-protection properties of the airplane. This AD requires
preparation of the affected surface areas to ensure that there is
adequate sealant adhesion, and complete encapsulation of the discrepant
fastener locations with the approved production sealant. The FAA is
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective October 20, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of October 20,
2022.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; internet www.myboeingfleet.com. You
may view this service information at the FAA, Airworthiness Products
Section, Operational Safety Branch, 2200 South 216th St., Des Moines,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available at www.regulations.gov by
searching for and locating Docket No. FAA-2021-1168.

Examining the AD Docket

    You may examine the AD docket at www.regulations.gov by searching
for and locating Docket No. FAA-2021-1168; or in person at Docket
Operations between 9 a.m. and 5 p.m., Monday through Friday, except
Federal holidays. The AD docket contains this final rule, any comments
received, and other information. The address for Docket Operations is
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: Chris Baker, Aerospace Engineer,
Propulsion Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des
Moines, WA 98198; phone and fax:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain The Boeing
Company Model 737-8 airplanes. The NPRM published in the Federal
Register on February 23, 2022 (87 FR 10110). The NPRM was prompted by a
report that, during production, a small number of fasteners common to
upper wing panel stringers U-S1, U-S10, U-S12, U-S20, and U-S21 and
lower wing panel stringer L-S14 were cap sealed on top of a black
stripe of ink with a clear overcoat. The black stripe of ink and clear
overcoat were applied during airplane assembly to certain interior
areas of the center fuel tank to ensure proper alignment of components,
and this discrepancy was not identified by Boeing prior to the delivery
of certain airplanes. The purpose of cap sealing is to provide a
secondary layer of lightning protection to the metal-to-metal rivet
installation bond. The clear overcoat is not an approved surface for
sealing and can potentially compromise sealant adhesion.
    Compromised sealant adhesion can, over time, affect the lightning
protection properties of the airplane. In the NPRM, the FAA proposed to
require preparation of the affected surface areas to ensure that there
is adequate sealant adhesion, and complete encapsulation of the
discrepant fastener locations with

the approved production sealant. This condition, if not addressed and
combined with a flammable center tank ullage and an independent failure
of the primary lightning protection feature, could result in ignition
of the fuel vapors and subsequent explosion in the event of a lightning
strike to that fastener.

Discussion of Final Airworthiness Directive

Comments

    The FAA received comments from Air Line Pilots Association,
International (ALPA) and an anonymous commenter, who supported the NPRM
without change.
    The FAA received additional comments from two commenters, Boeing
and Southwest Airlines (SWA). The following presents the additional
comments received on the NPRM and the FAA's response to each comment.

Request To Add Alternative Methods of Compliance to the Final Rule

    SWA requested that the FAA provide an option to operators that
would allow removal of the current application of BMS5-45 sealant in
the affected areas and removal of the black stripe of ink in accordance
with certain operator procedures (or other acceptable procedures), then
allowing for refinishing and sealing of the affected area in accordance
with certain other operator instructions. SWA reasoned that these
additional methods would address the unsafe condition and would allow
airworthiness limitation (AWL) inspections and standard maintenance to
be accomplished as intended in the structural repair manual (SRM) and
maintenance planning document (MPD).
    SWA explained that it is concerned that extending BMS5-45 sealant
0.6 inches beyond the current production application area could prevent
inspections performed in accordance with 737-7/8/8200/9/10
Airworthiness Limitations (AWL) D626A011-9-04 and MPD principal
structural element (PSE) 57-020-00. SWA went on to explain that
extending the BMS5-45 sealant up to 0.6 inches beyond the current
production application area to encapsulate the discrepant area
contradicts the sealant restoration procedures outlined in 737-8MAX SRM
51-80-01 which states, ``SEALANT MUST NOT EXTEND MORE THAN 0.125 INCH
(3.18mm) ON TO THE SURFACE OF THE PART FOR DAMAGE TOLERANCE INSPECTION
REASONS.'' SWA expressed concern that if an airplane requires repairs
or maintenance actions in the affected area, or requires AWL/MPD
required inspection 57-020-00, the BMS5-45 sealant will be stripped
and, if the affected area is restored in accordance with 737-8MAX SRM
51-80-01, could lead to an operator inadvertently undoing the actions
specified in Boeing Special Attention Requirements Bulletin 737-57-1352
RB, dated February 1, 2021.
    The FAA agrees that the service bulletin instructions could
conflict with future actions required by the 737-7/8/8200/9/10
Airworthiness Limitations (AWL) D626A011-9-04, in that the added
sealant might impede the operator's ability to inspect the structure.
The FAA also agrees that operators could use the existing sealant
restoration procedures to remove the current application of BMS5-45
sealant in the discrepant areas, remove the black stripe of ink in
accordance with acceptable surface preparation procedures, and reseal
the fasteners in accordance with standard sealing procedures of
fasteners penetrating the fuel tank. The FAA has added an optional
method of removing the existing sealant and black stripe of ink prior
to reapplying a fastener seal in paragraph (h) of this AD and
redesignated subsequent paragraphs.

Request for Additional Detail to the Unsafe Condition Statement

    Boeing requested that the unsafe condition statement found in the
Background section of the preamble and paragraph (e) of the proposed AD
include more detail of the conditions and failures required for a fuel
tank ignition to occur. Boeing stated that in the proposed AD, the
unsafe condition statement lists only compromised sealant adhesion as
the condition needed for an ignition of fuel tank vapors in the event
of a lightning strike. Boeing pointed out that ignition of fuel tank
vapor requires an independent failure of the primary ignition
prevention feature, a failed cap seal, a lightning attachment to the
particular fastener, and that the fuel tank is flammable.
    Boeing requested that the FAA change the fifth sentence in the
Background section of the proposed AD to state, ``This condition, if
not addressed and combined with a flammable center tank ullage and an
independent failure of the primary lightning protection feature, could
result in ignition of the fuel vapors and subsequent explosion in the
event of a lightning strike to that fastener.'' Boeing requested
similar changes to the second sentence of paragraph (e) of the proposed
AD.
    The FAA agrees with the request for the reasons provided. Boeing
provided a more detailed description of the potential failure sequence.
The FAA has revised the Background section of this final rule and the
second sentence of paragraph (e) of this AD accordingly.

Conclusion

    The FAA reviewed the relevant data, considered any comments
received, and determined that air safety requires adopting this AD as
proposed. Except for minor editorial changes, and any other changes
described previously, this AD is adopted as proposed in the NPRM. None
of the changes will increase the economic burden on any operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Boeing Special Attention Requirements Bulletin
737-57-1352 RB, dated February 1, 2021. This service information
specifies procedures for preparing the surface and completely
encapsulating the black stripe of ink, the clear overcoat, and the
existing sealant with the approved production (BMS5-45) sealant at
upper stringer U-S1, U-S10, U-S12, U-S20, and U-S21, and lower stringer
L-S14. The affected areas are all located on the portion of the
stringers just outboard of the center wing box. 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 ADDRESSES.

Costs of Compliance

    The FAA estimates that this AD affects 11 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Apply Sealant.......................  106 work-hours x $85               $500           $9,510         $104,610
                                       per hour = $9,010.
----------------------------------------------------------------------------------------------------------------

                                      Estimated Costs for Optional Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Remove Sealant and Black Stripe of Ink, and     118 work-hours x $85 per hour =             $500         $10,030
 Reapply Fastener Seal.                          $10,030.
----------------------------------------------------------------------------------------------------------------

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some or all of the costs of
this AD may be covered under warranty, thereby reducing the cost impact
on affected operators.

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.
    The FAA is 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) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

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:

2022-16-09 The Boeing Company: Amendment 39-22138; Docket No. FAA-
2021-1168; Project Identifier AD-2021-00825-T.

(a) Effective Date

    This airworthiness directive (AD) is effective October 20, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 737-8 airplanes,
certificated in any category, as identified in Boeing Special
Attention Requirements Bulletin 737-57-1352 RB, dated February 1,
2021.

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Unsafe Condition

    This AD was prompted by a report that, during production, a
small number of fasteners in certain locations of the center fuel
tank were cap sealed on top of a black stripe of ink with a clear
overcoat. This clear overcoat is not an approved surface for sealing
and can potentially compromise sealant adhesion. Compromised sealant
adhesion can, over time, affect the lightning protection properties
of the airplane. The FAA is issuing this AD to address compromised
sealant adhesion within the center fuel tank, which, if combined
with a flammable center tank ullage and an independent failure of
the primary lightning protection feature, could result in ignition
of fuel vapors and subsequent explosion of the fuel tank in the
event of a lightning strike to that fastener.

(f) Compliance

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

(g) Required Actions

    Within 10 years after the date of issuance of the original
airworthiness certificate or the original export certificate of
airworthiness, do all applicable actions identified in, and in
accordance with, the Accomplishment Instructions of Boeing Special
Attention Requirements Bulletin 737-57-1352 RB, dated February 1,
2021, except as specified by paragraph (h) of this AD.
    Note 1 to paragraph (g): Guidance for accomplishing the actions
required by this AD can be found in Boeing Special Attention Service
Bulletin 737-57-1352, dated February 1, 2021, which is referred to
in Boeing Special Attention Requirements Bulletin 737-57-1352 RB,
dated February 1, 2021.

(h) Optional Method To Remove Previously Applied Sealant and Black
Stripe of Ink, and Reapply Fastener Seal

    As an option to the sealant application required by paragraph
(g) of this AD, it is acceptable to remove the existing sealant and
the black stripe of ink prior to reapplying a fastener seal. Remove
existing sealant and black stripe of ink as follows:
    (1) Remove existing sealant to expose the black stripe of ink.
    (2) Remove existing black stripe of ink using aluminum oxide
cloth or paper, 150 to 220 grit.
    Note 2 to paragraph (h)(2): Take caution not to abrade through
the existing oven cured BMS10-20 coating under the black stripe of
ink. The BMS10-20 was previously applied during production.
    (3) Touch up exposed aluminum with Alodine 600 (Type I, II, or
III) or Bonderite M-CR 600 Aero (Type I, II, or III).
    (4) Apply fastener seal (cap seal) with BMS5-45.
    (5) Apply BMS10-20 Type II fuel tank coating to any exposed
alodine/bonderite surfaces not covered by the fastener seal; it is
acceptable to extend BMS10-20 Type II coating over fastener seal.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO Branch, 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 responsible Flight Standards Office,
as appropriate. If sending information directly to the manager of
the certification office, send it to the attention of the person
identified in paragraph (j)(1) of this AD. Information may be
emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards Office.

    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by The Boeing Company Organization Designation
Authorization (ODA) that has been authorized by the Manager, Seattle
ACO Branch, FAA, to make those findings. To be approved, the repair
method, modification deviation, or alteration deviation must meet
the certification basis of the airplane, and the approval must
specifically refer to this AD.

(j) Related Information

    (1) For more information about this AD, contact Chris Baker,
Aerospace Engineer, Propulsion Section, FAA, Seattle ACO Branch,
2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-
3552; email: [email protected].
    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (k)(3) and (4) of this AD.

(k) 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) Boeing Special Attention Requirements Bulletin 737-57-1352
RB, dated February 1, 2021.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; internet www.myboeingfleet.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (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, [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on July 29, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-19902 Filed 9-14-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 155 (Thursday, August 11, 2011)]
[Notices]
[Pages 49781-49782]
[FR Doc No: 2011-20366]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4005-DR; Docket ID FEMA-2011-0001]

Tennessee; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Tennessee (FEMA-4005-DR), dated July 20, 2011, and
related determinations.

DATES: Effective Date: August 1, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the

State of Tennessee is hereby amended to include the following area
among those areas determined to have been adversely affected by the
event declared a major disaster by the President in his declaration of
July 20, 2011.

Anderson County for Public Assistance.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-20366 Filed 8-10-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: July 30, 2009 (Volume 74, Number 145)]
[Notices]
[Page 38035-38036]
[DOCID:fr30jy09-67]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0128] (formerly Docket No. 2007D-0396)

Guidance for Industry on Drug-Induced Liver Injury: Premarketing
Clinical Evaluation; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Drug-Induced Liver
Injury: Premarketing Clinical Evaluation.'' This guidance is intended
to assist the pharmaceutical industry and others engaged in new drug
development in the assessment of the potential of a drug to cause
severe drug-induced liver injury (DILI) during the conduct of
premarketing trials. This guidance defines severe DILI as injury that
is fatal or requires liver transplantation.

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, 1401 Rockville Pike, suite 200N, Rockville, MD
20852-1448. The guidance may also be obtained from the Center for
Biologics Evaluation and Research by mail by calling 1-800-835-4709 or
301-827-1800. Send one self-addressed adhesive label to assist that
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:
    Hee Shelia Lianos, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5329,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
    Steve Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Drug-Induced Liver Injury: Premarketing Clinical
Evaluation.'' Severe DILI has been an important cause of drug marketing
withdrawal. This has led FDA to pay particular attention to how the
risk of severe DILI can be predicted before a drug is approved. The
science of detecting and evaluating DILI during drug development is
evolving, and FDA is working with industry, academia, and other
government groups toward better understanding of how best to do this.
    Even for drugs that prove to be significant hepatotoxins in some
patients (e.g., bromfenac, troglitazone, and ximelagatran), it is
unlikely that cases of severe DILI will be identified during a drug
development program with only a few thousand exposed subjects.
Therefore, it is critical to discover signals of a drug's potential to
cause such injury during drug development by detection of lesser
degrees of liver injury that may be more frequently seen. There are a
number of such signals that have varying levels of sensitivity and
specificity in predicting the potential for severe DILI. However, the
most specific finding to date is a finding of cases of serum
aminotransferase elevation together with elevated bilirubin
concentration (and no evidence of biliary obstruction or impaired
ability to conjugate bilirubin) in some trial subjects (i.e., Hy's Law
cases).

    The guidance describes the sensitivity and specificity of various
indicators of hepatotoxic potential, as well as the observations needed
to evaluate those indicators, including detection, confirmation and
monitoring of liver test abnormalities, close evaluation and exclusion
of other causes, and careful supportive care and follow-up to normality
or return to baseline status. The guidance makes specific
recommendations about the use of Hy's Law and interpretation of Hy's
Law cases that are identified during clinical development and suggests
research opportunities to learn more about what makes certain people
more susceptible to DILI than are most persons exposed to the drug.
    The guidance was issued in draft form in October 2007 for public
comments. We received a total of 12 comments submitted to Docket No.
2007D-0396. FDA organized a public meeting in March 2008 for discussion
of issues raised by the draft guidance and reopened the public comment
period from March 6, 2008, to June 30, 2008, with Docket No. FDA-2008-
D-0128 (formerly Docket No. 2007D-0396). One comment was submitted to
Docket No. FDA-2008-D-0128. The comments are available at http://
www.fda.gov/Drugs/ScienceResearch/ResearchAreas/ucm071471.htm.
Presentations, discussion, and materials from the March 2008 public
meeting also are available at the above Web site.
    FDA considered written and verbal comments submitted to the dockets
and at the public meeting before finalizing the guidance. The guidance
reflects clarifying and editorial changes made in response to comments
and at our own initiative.
    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 premarketing evaluation of a drug's
potential for causing severe DILI. 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. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that 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 parts 312, 314, and 601
have been approved under OMB Control Numbers 0910-0014, 0910-0001, and
0910-0338, respectively.

III. 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.

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/cber/guidelines.htm, or
http://www.regulations.gov.

    Dated: July 22, 2009.
Jeffrey Shuren,
Associate Comissioner for Policy and Planning.
[FR Doc. E9-18135 Filed 7-29-09; 8:45 am]

BILLING CODE 4160-01-S


From:
Jones, DonnaLee<EMAIL_ADDRESS>Sent:
Friday, August 26, 2016 12:55 PM
To:
<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Cc:
David Ailor<EMAIL_ADDRESS><EMAIL_ADDRESS>Raymond, Gabrielle<EMAIL_ADDRESS>Subject:
Additional FAQ on M0031 during pushing

An additional FAQ:

24.     We are going to be testing on a pushing process next week that pushes for roughly 2 minutes, then is down for around 10 minutes. For a 12-hour shift, I believe there will be about 48 pushes. We are running into difficulty trying to figure out how to sample the Method 0031 train (for VOHAP) and collect a good, representative sample within the confines of the method which requires 20 minutes of sample/set of traps, 120 minutes of sample time, etc.. The problem is that I don't think we can get the 120 minutes of sample, which means we then leave the train assembled and covered overnight, which doesn't bode well for our data on the back end I wouldn't think.

EPA Response: The 2-hour sampling time in the method is assuming a constant process. Since this process is intermittent, you may disregard the total sampling time requirement.  Hopefully, this will alleviate your concern with leaving the train assembled and covered overnight

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02) Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

________________________________________
From: Jones, DonnaLee
Sent: Friday, August 19, 2016 12:17:40 PM
To<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Cc: David Ailor (dailor@accci.org); GABRIELLE RAYMOND
Subject: updated FAQs for Coke Ovens ICR - Qs #1-#23 - New Qs starts at #18

Please find attached updated FAQs for the Coke Oven ICR. Also posted to Coke ICR website.

Questions #1 through #23 (new FAQs start at #18)   -  August 16, 2016

_____________________________________________________________
Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D 243-02) Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.


[Federal Register: July 26, 2010 (Volume 75, Number 142)]
[Notices]
[Page 43537]
[DOCID:fr26jy10-65]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1922-DR; Docket ID FEMA-2010-0002]

Montana; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Montana (FEMA-1922-DR), dated July 10, 2010,
and related determinations.

DATES: Effective Date: July 10, 2010.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated July 10, 2010, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of Montana resulting from severe storms and flooding beginning on
June 15, 2010, and continuing, is of sufficient severity and
magnitude to warrant a major disaster declaration under the Robert
T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121 et seq. (the ``Stafford Act''). Therefore, I declare that such
a major disaster exists in the State of Montana.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Steven S. Ward, of FEMA is appointed
to act as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of Montana have been designated as
adversely affected by this major disaster:

    Hill County and the Rocky Boy's Indian Reservation for Public
Assistance.
    All counties and Tribes within the State of Montana are eligible
to apply for assistance under the Hazard Mitigation Grant Program.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-18199 Filed 7-23-10; 8:45 am]
BILLING CODE 9111-23-P


  SEQ CHAPTER \h \r 1 Form for Compliance with E.O. 12866 Docket Requirements

Title of Regulation:   National Primary Drinking Water Regulations:  Ground Water Rule

Contact person:   Michael Finn

Phone number:<PHONE_NUMBER>

Was this regulation reviewed by OMB under Executive Order  12866 - Regulatory Planning and Review?

Yes          No

If you checked “no”, you are done with this form.  Simply place it in the docket for your regulation.  If you checked “yes”, please fill out the remainder of the form before placing it in the docket.  Also docket any relevant documents referenced in the form.

For regulations that are checked “Yes” above:

This regulation was reviewed by OMB under Executive Order  12866 - Regulatory Planning and Review.

Attached is the draft regulation and any other documents sent to OMB for review, such as analyses and assessments.   E.O. 12866 requires agencies to make these publicly available.

E.O. 12866 also requires agencies to identify the substantive changes between the draft regulation sent to OMB for review and the regulation subsequently announced  [Please check the appropriate box below:]

   X     	EPA made substantive changes to this regulation

(includes changes initiated by EPA or OMB).

Attached is a document which: (1) identifies all the substantive changes made, and (2) notes those changes OMB suggested or recommended.

        	No substantive changes were made to this regulation

ê

î

-

/

0

ä

å

,

0

¤

	Therefore, no further attachments are required..

If you have questions about this regulation, please call the EPA contact person listed above.