[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)]
[Notices]
[Pages 64177-64178]
[FR Doc No: 2016-22470]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2610]

A List of Biomarkers Used as Outcomes in Development of FDA-
Approved New Molecular Entities and New Biological Therapeutics
(October 2007 to December 2015); Establishment of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the establishment of a docket to receive suggestions, recommendations,
and comments from interested parties (such as academic researchers,
regulated industries, consortia, and patient groups) on a list of
biomarkers that were used as outcomes to develop FDA-approved new
molecular entities (NMEs) and New Biological Therapeutics from October
2007 to December 2015. Comments received on this list will help FDA
determine the utility of the list and may assist FDA in developing
databases on biomarkers for drug development in the future.

DATES: Submit either electronic or written comments by November 18,
2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

do not wish to be made available to the public submit the comment as a
written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-N-2610 for ``A List of Biomarkers Used as Outcomes in
Development of FDA-Approved New Molecular Entities and New Biological
Therapeutics (October 2007 to December 2015); Establishment of Public
Docket.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Marianne Noone, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, Rm. 4528, Silver Spring, MD 20993-0002, 301-
796-2600.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is committed to support more efficient drug development by
providing scientific, technical, and regulatory advice to stakeholders
(such as to pharmaceutical industries, academia, patient advocacy
groups, and consortia). As part of this commitment, FDA is providing a
list of biomarkers that were used as outcomes in the development of
FDA-approved NMEs and New Biological Therapeutics in different disease
areas from October 2007 to December 2015. This list is intended to
provide examples of biomarkers that were accepted and used as endpoints
in clinical trials for drug and biologic approvals from October 2007 to
December 2015. This list, along with brief background information, is
accessible at Biomarkers Used as Outcomes in Development of FDA-
Approved Therapeutics (October 2007 to December 2015).

II. Establishment of a Public Docket and Request for Comments

    FDA is soliciting suggestions and comments from stakeholders to
determine the utility of the biomarker outcomes list and to identify
any areas of improvement for disseminating information on biomarkers
that have been used to support the approval of drugs or biologics.
Specifically, FDA welcomes comments regarding the following two areas:
     Areas of improvement for communicating and disseminating
information about biomarkers and their utility as drug development
tools.
     The best approach for updating the biomarkers outcomes
list, including any modifications of the list, in the future.
    FDA will consider all comments submitted but will generally not
respond directly to the person or organization submitting the comment.

    Dated: September 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22470 Filed 9-16-16; 8:45 am]
BILLING CODE 4164-01-P


Questions for BWXT

February 4, 2004

1.  Page 14 of the petition states that, “Prior to June 1990, the PA filter cake was managed as a non-hazardous solid waste.  The management of the PA filter cake included its disposal in Landfill No. 1 and Landfill No. 2.”

	Q.  Were wastes other than PA filter cake disposed of in these units?

2.  Page 44 of the petition states that, “Tables 1 and 2 (Exhibit 6) identify chemicals that are not hazardous to human health and chemicals that are not discharged to the waste treatment facilities.  Therefore these chemicals have been eliminated from further consideration.”  The petition text than lists “elimination categories,” some of which appear as parentheticals in these tables, and some do not.

	Q.  Please clarify the status of the chemicals on Tables 1-5 in Exhibit 6.

3.  Exhibit 6, Table 3 lists the solvent EZE-431.  However, this Trade Name chemical compound does not appear on Table 4.

	Q.  Please provide a description of this solvent.

4.  Page 12 of the petition states that, “...NPD has been engaged in the production and assembly of components primarily for the United States government, which involves the use of Special Nuclear Materials, primarily unirradiated enriched uranium.”

Page 30 of the petition states that, “BWXT recovers uranium using an acid dissolution process.  Clad fuel components are dissolved in a solution of nitric acid, hydrofluoric acid, and aluminum nitrate.”

Q.  Are clad fuel components spent fuel rods?  Spent fuel rods are classified as irradiated material.

5.  Page 31 includes a description of the Compact Reactor Fuel Development Process.  Included in the process is the use of unspecified organic solutions.

Q.  Do concentrations of the organic solutions end up in the wastewater?  If so, what are the organic compounds.

6.  Page 30 contains a description of the downblending operations.  Page 31 indicates that, “The purpose of the CRF Process is to convert uranium solutions into fuel.

Q.  Do these processes include the conversion of uranyl nitrate to uranyl dioxide, or to uranium metal?  If so, how is this accomplished?

7.  The data on the sludge from the October 1993 study shows that the majority of the activity is associated with the isotope U234.

Q.  Does BWXT separate out U234 as a contaminant?  Does BWXT use TOPO (trioctyl phosphine oxide)?


MEMORANDUM May 2005 Subject: Product Chemistry of : Para Tertiary Amylphenol( PC Code: 64101), Par Tertiary Amylphenol, Sodium Salt ( PC Code 64112), and Para Tertiary Amylphenol, Potassium Salt ( PC Code 64111)

From: A. Najm Shamim, Ph. D., Chemist Regulatory Management Branch II Antimicrobials Division ( 7510C)

To: Tim McMahon, Ph. D., Senior Toxicologist Chair, ADTC of Antimicrobials Division Antimicrobials Division ( 7510C)

Thru: Ben Chambliss, Acting Team Leader Regulatory Management Branch II Antimicrobials Division ( 7510C)

And Deborah Smegal, Science Coordinator for PTAP Risk Assessment and Science Support Branch Antimicrobials Division ( 7510C)

Mark Hartman, Chief Regulatory Management Branch II Antimicrobials Division ( 7510C)

DP BARCODE: 316275 PC CODE: 64101 Enclosed is product chemistry chapter submitted for the Reregistration Eligibility Decision ( RED) process.

4 TERTIARY AMYLPHENOL Chemical Name: p Tertiary  Amylphenol OR 4 Tertiary Amylphenol Common and or Trade Name: NIPACIDE ® PTAP/ PENTAPHEN 67 PC Code: 64101 CAS#: 80 46 6 Molecular Formula: C 5 H 11  C 6 H 4  OH Molecular Weight: 164.25 M. P. 95 o C B. P. 263o C Vapor Pressure: 1.16 x 10 3 mm Hg at 25 o C Solubility in Water: 113.4 mg/ L Log K ow 3.91( estimated) 1 Henry Law Constant ( HLC): 2.03 x 10 6 atm m3/ mol ( estimated) 1 Log K oc : 3.57 ( estimated) 1 Physical State: White Solid Persistence in Air ( t ½ in Air): 3.073 hours ( measured against hydroxy radical) 1 4 TERTIARY  AMYLPHENOL SODIUM SALT Chemical Name: Phenol, 4( 1,1 Dimethylpropyl) Sodium Salt PC Code: 64112 CAS#: 31366 95 7 Molecular Formula: C 5 H 11  C 6 H 4  O Na+ Molecular Weight: 186.23 M. P. 205 o C ( estimated) 1 B. P. 485 o C ( estimated) 1 Vapor Pressure: 7.7 x10 10 ( estimated) 1 At 25o C Solubility in Water: 4595 mg/ L ( estimated) 1 Log K ow : 1.23 Henry law Constant ( HLC): 4.10 x 10 14 atm m3 / mole ( estimated) 1 Log K oc : 3.57 Persistence in Air ( t ½ in Air): 4.67 hours ( measured against hydroxy radical) 1 Physical State: Solid 4 TERTIARY AMYLPHENOL POTASSIUM SALT Chemical Name: Phenol, 4( 1,1 Dimethylpropyl), Potassium Salt PC Code: 64111 CAS#: 53404 18 5 Molecular Formula: C 5 H 11  C 6 H 4  OK+ Molecular Weight: 202.34 M. P. 206 o C BP: 486 o C Vapor pressure: 7.7 x10 10 mm Hg at 25 o C ( estimated) 1 Solubility in Water: 3811 mg/ L at 25 o C ( estimated) 1 Log K ow : 1.23 ( estimated) 1 Henry law Constant ( HLC): 5.38 x 10 14 atm m3 / mole ( estimated) 1 Log K oc : 3.57 ( estimated) 1 Persistence in Air ( t ½ in Air): 4.67 hours ( measured against hydroxy radical) 1 Physical State: Solid BIBLIOGRAPHY MRID# CITATIONS 1  US EPA's Estimation of P/ Chem Properties Program, EPI Suite


[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Page 57177]
[FR Doc No: 2021-22433]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4620-DR; Docket ID FEMA-2021-0001]

Arizona; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Arizona (FEMA-4620-DR), dated September 13,
2021, and related determinations.

DATES: The declaration was issued September 13, 2021.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated September 13, 2021, 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 Arizona resulting from severe storms and flooding during the
period of July 22 to July 24, 2021, 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 Arizona.
    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 be
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, Benigno Bern Ruiz, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Arizona have been designated as
adversely affected by this major disaster:

    Apache, Coconino, and Navajo Counties for Public Assistance.
    All areas within the State of Arizona are eligible 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.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-22433 Filed 10-13-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: September 29, 2008 (Volume 73, Number 189)]
[Rules and Regulations]
[Page 56462-56464]
[DOCID:fr29se08-7]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0361; Directorate Identifier 2007-NM-279-AD;
Amendment 39-15681; AD 2008-20-02]
RIN 2120-AA64

Airworthiness Directives; Empresa Brasileira de Aeronautica S.A.
(EMBRAER) Model ERJ 170 and ERJ 190 Airplanes

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

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    A few hydraulic system tube clamps located inside the wing fuel
tanks were found damaged. Further analysis has shown that damage to
multiple clamps may cause sparks inside the tanks, which in turn may
lead to ignition of flammable vapors inside the fuel tanks.

We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective November 3, 2008.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of November 3,
2008.

ADDRESSES: You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Kenny Kaulia, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-2848; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on March 28, 2008 (73
FR 16575). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    A few hydraulic system tube clamps located inside the wing fuel
tanks were found damaged. Further analysis has shown that damage to
multiple clamps may cause sparks inside the tanks, which in turn may
lead to ignition of flammable vapors inside the fuel tanks.

The corrective action includes replacing tube attachment clamps having
certain part numbers with new tube attachment clamps. You may obtain
further information by examining the MCAI in the AD docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comments received.

Request To Add Revised Service Information

    EMBRAER states that Service Bulletin 170-29-0006 was revised to
include additional airplanes in the effectivity. Therefore, EMBRAER
recommends that the AD applicability refers to Service Bulletin 170-29-
0006, Revision 01, dated February 22, 2008. The original issue, dated
October 4, 2006, was referred to in the NPRM as the source of service
information for accomplishing certain actions. EMBRAER adds that the
original issue should be kept as an acceptable means of compliance.
    We agree that the applicability in the NPRM should be changed.
Revision 01 of the service bulletin includes a reference to ``EMBRAER
175 ( ) model aircraft,'' which is the marketing designation for a
certain version of the Model ERJ 170 airplane. However, no additional
airplanes have been added to the service bulletin effectivity. We have
changed the service bulletin reference in paragraph (c) of this AD from
the original issue to Revision 01.
    In addition, we agree to change paragraph (f) of the AD to refer to
Revision 01 of the referenced service bulletin. Revision 01 specifies
that there is no additional action for airplanes on which the actions
in the original issue of the service bulletin have been done. We have
also added a new paragraph (f)(3) to this AD to give operators credit
for doing the actions in the original issue of the service bulletin.

Request To Change Paragraph (e)

    EMBRAER also recommends changing paragraph (e) of the NPRM to add
the phrase, ``in conjunction with a lightning strike'' following the
words ``multiple clamps'' as specified in that paragraph. EMBRAER did
not provide a justification for this change.
    We do not agree that paragraph (e) of the NPRM should be changed.
Paragraph (e) of this AD quotes the requirements in the MCAI verbatim;
therefore, no change to the AD is necessary in this regard.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously. We also determined that
these changes will not increase the economic burden on any operator or
increase the scope of the AD.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a NOTE within the AD.

Costs of Compliance

    We estimate that this AD will affect 88 products of U.S. registry.
We also estimate that it will take 18 work-hours per product to comply
with the basic requirements of this AD. The average labor rate is $80
per work-hour. Required parts will cost about $269 per product. Where
the service information lists required parts costs that are covered
under warranty, we have assumed that there will be no charge for these
parts. As we do not control warranty coverage for affected parties,
some parties may incur costs higher than estimated here. Based on these
figures, we estimate the cost of this AD to the U.S. operators to be
$150,392, or about $1,709 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation Programs''
describes in more detail the scope of the Agency's authority.

    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this 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 this AD:
    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); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2008-20-02 Empresa Brasileira de Aeronautica S.A. (EMBRAER:
Amendment 39-15681. Docket No. FAA-2008-0361; Directorate Identifier
2007-NM-279-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective November
3, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to EMBRAER Model ERJ 170-100 LR, -100 STD, -
100 SE, -100 SU, -200 LR, -200 STD, and -200 SU airplanes; as
identified in EMBRAER Service Bulletin 170-29-0006, Revision 01,
dated February 22, 2008; and Model ERJ 190-100 STD, -100 LR, -100
IGW, -200 STD, -200 LR, and -200 IGW airplanes; as identified in
EMBRAER Service Bulletin 190-29-0003, dated October 4, 2006;
certificated in any category.

Subject

    (d) Air Transport Association (ATA) of America Code 29:
Hydraulic Power.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    A few hydraulic system tube clamps located inside the wing fuel
tanks were found damaged. Further analysis has shown that damage to
multiple clamps may cause sparks inside the tanks, which in turn may
lead to ignition of flammable vapors inside the fuel tanks.

The corrective action includes replacing tube attachment clamps
having certain part numbers with new tube attachment clamps.

Actions and Compliance

    (f) Unless already done: Within 8,000 flight hours after the
effective date of this AD, replace the clamps which attach the
hydraulic tubes inside the wing fuel tanks with new clamps, as
specified in paragraph (f)(1) or (f)(2) of this AD, as applicable;
in accordance with the Accomplishment Instructions of EMBRAER
Service Bulletin 170-29-0006, Revision 01, dated February 22, 2008;
or 190-29-0003, dated October 4, 2006; as applicable.
    (1) For Model ERJ 170 airplanes: Replace any clamp having part
number (P/N) PE27019RF4E with a new clamp having P/N PE27019FS4E;
and any clamp having P/N PE27019RF8E with a new clamp having P/N
PE27019FS8E.
    (2) For Model ERJ 190 airplanes: Replace any clamp having P/N
PE27019RF4E with a new clamp having P/N PE27019FS4E; and any clamp
having P/N PE27019RF6E with a new clamp having P/N PE27019FS6E.
    (3) Actions accomplished before the effective date of this AD in
accordance with EMBRAER Service Bulletin 170-29-0006, dated October
4, 2006, are considered acceptable for compliance with the
corresponding actions specified in paragraph (f) of this AD.

FAA AD Differences

    Note 1: This AD differs from the MCAI and/or service information
as follows. No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN:
Kenny Kaulia, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI Brazilian Airworthiness Directives 2007-04-
01R1 and 2007-04-02R1 (including Errata, effective December 21,
2007), both effective December 21, 2007; and EMBRAER Service
Bulletins 170-29-0006, Revision 01, dated February 22, 2008; and
190-29-0003, dated October 4, 2006; for related information.

Material Incorporated by Reference

    (i) You must use EMBRAER Service Bulletin 170-29-0006, Revision
01, dated February 22, 2008; or EMBRAER Service Bulletin 190-29-
0003, dated October 4, 2006; as applicable, to do the actions
required by this AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Empresa Brasileira de Aeronautica S.A. (EMBRAER), P.O. Box

343--CEP 12.225, Sao Jose dos Campos--SP, Brazil.
    (3) You may review copies at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>,
or go to: http://www.archives.gov/federal-register/cfr/ibr-
locations.html.

    Issued in Renton, Washington, on September 12, 2008.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E8-22205 Filed 9-26-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: September 2, 2010 (Volume 75, Number 170)]
[Notices]
[Page 53964]
[DOCID:fr02se10-51]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR10-84-000; PR10-85-000]

Centana Intrastate Pipeline, LLC; Notice of Filing

August 27, 2010.
    Take notice that on August 25, 2010, Centana Intrastate Pipeline,
LLC (Centana) filed in compliance to Delegated Letter Order issued July
26, 2010, in Docket Nos. PR10-9-000 and PR10-9-001. Centana filed
revised Statement of Operating Conditions (SOC) for its Storage
Services and Transportation Services, incorporating all information
relevant to parking and lending services and including revised stand-
alone rate sheets listing all services offered and their respective
minimum and maximum rates.
    Any person desiring to participate in this rate filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 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 date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not 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 14 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 review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern time on Wednesday, September 8, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-21972 Filed 9-1-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 236 (Monday, December 10, 2018)]
[Rules and Regulations]
[Pages 63406-63407]
[FR Doc No: 2018-26498]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2018-0699; Airspace Docket No. 18-ASW-11]
RIN 2120-AA66

Amendment of Class D and E Airspace and Revocation of Class E
Airspace; Fayetteville, AR

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action modifies Class D airspace and Class E airspace
designated as a surface area, and removes Class E airspace designated
as an extension to a Class D and Class E airspace at Drake Field,
Fayetteville, AR. This action is due to the decommissioning of the
Drake VHF omnidirectional range (VOR) navigation aid, which provided
navigation information for the instrument procedures at this airport,
as part of the VOR Minimum Operational Network (MON) Program. The
geographic coordinates of the airport are also updated to coincide with
the FAA's aeronautical database. Airspace redesign is necessary to
support instrument flight rule (IFR) operations at this airport.

DATES: Effective 0901 UTC, February 28, 2019. The Director of the
Federal Register approves this incorporation by reference action under
Title 1 Code of Federal Regulations part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11C, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11C at NARA, call<PHONE_NUMBER>, or go
to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it modifies Class D airspace and Class E airspace designated as a
surface area, and removes Class E airspace designated as an extension
to a Class D and Class E airspace at Drake Field, Fayetteville, AR, to
support IFR operations at this airport.

History

    The FAA published a notice of proposed rulemaking (NPRM) in the
Federal Register (83 FR 47585; September 20, 2018) for Docket No. FAA-
2018-0699 to amend Class D airspace and Class E airspace designated as
a surface area, and remove Class E airspace designated as an extension
to a Class D and Class E airspace at Drake Field, Fayetteville, AR.
Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received.
    Subsequent to publication, the FAA found a typographic error in the
airspace legal description for the Class D airspace and Class E
airspace designated as a surface area in the extension from the Drake
Field: RWY 34-LOC. ``Sided'' should have been ``side''. This
typographical error is corrected in this rule.
    Class D and E airspace designations are published in paragraphs
5000, 6002, and 6004, respectively, of FAA Order 7400.11C, dated August
13, 2018, and effective September 15, 2018, which is incorporated by
reference in 14 CFR 71.1. The Class D and E airspace designations
listed in this document will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11C, Airspace Designations and
Reporting Points, dated August 13, 2018, and effective September 15,
2018. FAA Order 7400.11C is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11C lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This rule amends Title 14 Code of Federal Regulations (14 CFR) part
71 by: Amending the Class D airspace at Drake Field, Fayetteville, AR,
to within a 4-mile radius (decreased from a 4.1-mile radius); and
adding an extension 1.1 miles each side of the 181[deg] bearing from
the airport from the 4-mile radius to 5.9 miles north of the airport,
and adding an extension 1 mile each side of the 172[deg] bearing from
the Drake Field: RWY 34-LOC from the 4-mile radius to 4.9 miles

south of the Drake Field: RWY 34-LOC; and adding an extension 1 mile
each side of the 347[deg] bearing from the airport from the 4-mile
radius to 4.9 miles north the airport. The city associated with the
airport is removed from the airspace legal description to comply with a
change to FAA Order 7400.2L, Procedures for Handling Airspace Matters,
and the outdated term ``Airport/Facility Directory'' is updated to
``Chart Supplement.'' Additionally, the geographic coordinates of the
airport are updated to coincide with the FAA's aeronautical database.
    Amending the Class E airspace designated as a surface area at Drake
Field to within a 4-mile radius (decreased from a 4.1-mile radius); and
extending the airspace up to and including 3,800 feet MSL; and adding
an extension 1.1 miles each side of the 181[deg] bearing from the
airport from the 4-mile radius to 5.9 miles south of the airport, and
adding an extension 1 mile each side of the 172[deg] bearing from the
Drake Field: RWY 34-LOC from the 4-mile radius to 4.9 miles south of
the Drake Field: RWY 34-LOC; and adding an extension 1 mile each side
of the 347[deg] bearing from the airport from the 4-mile radius to 4.9
miles north of the airport. The city associated with the airport is
removed from the airspace legal description to comply with a change to
FAA Order 7400.2L, and the outdated term ``Airport/Facility Directory''
is updated to ``Chart Supplement.'' Additionally, the geographic
coordinates of the airport are updated to coincide with the FAA's
aeronautical database.
    And removing the Class E airspace designated as an extension to
Class D and Class E at Drake Field as it is no longer required.
    The typographical error in the airspace legal description for the
Class D airspace and Class E airspace designated as a surface area in
the extension from the Drake Field: RWY 34-LOC changing ``sided'' to
``side'' is corrected in this rule. Except for this change, this rule
is the same as published in the NPRM.
    This action as the result of an airspace review caused by the
decommissioning of the Drake VOR, which provided navigation information
for the instrument procedures at this airport, as part of the VOR MON
Program.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

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

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11B,
Airspace Designations and Reporting Points, dated August 3, 2017, and
effective September 15, 2017, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ASW AR D Fayetteville, AR [Amended]

Drake Field, AR
    (Lat. 36[deg]00'18'' N, long. 94[deg]10'12'' W)
Drake Field: RWY 34-LOC
    (Lat. 36[deg]00'26'' N, long. 94[deg]10'10'' W)

    That airspace extending upward from the surface to and including
3,800 feet MSL within a 4-mile radius of Drake Field, and within 1.1
miles each side of the 181[deg] bearing from the airport from the 4-
mile radius to 5.9 miles south of the airport, and within 1 mile
each side of the 172[deg] bearing from the Drake Field: RWY 34-LOC
from the 4-mile radius to 4.9 miles south of the Drake Field: RWY
34-LOC, and within 1 mile each side of the 347[deg] bearing from the
airport from the 4-mile radius to 4.9 miles north of the airport.
This Class D airspace area is effective during the specific dates
and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Chart Supplement.

Paragraph 6002 Class E Airspace Areas Designated as Surface Areas.

* * * * *

ASW AR E2 Fayetteville, AR [Amended]

Drake Field, AR
    (Lat. 36[deg]00'18'' N, long. 94[deg]10'12'' W)
Drake Field: RWY 34-LOC
    (Lat. 36[deg]00'26'' N, long. 94[deg]10'10'' W)

    That airspace extending upward from the surface to and including
3,800 feet MSL within a 4-mile radius of Drake Field, and within 1.1
miles each side of the 181[deg] bearing from the airport from the 4-
mile radius to 5.9 miles south of the airport, and within 1 mile
each side of the 172[deg] bearing from the Drake Field: RWY 34-LOC
from the 4-mile radius to 4.9 miles south of the Drake Field: RWY
34-LOC, and within 1 mile each side of the 347[deg] bearing from the
airport from the 4-mile radius to 4.9 miles north of the airport.
This Class E airspace area is effective during the specific dates
and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Chart Supplement.

Paragraph 6004 Class E Airspace Designated as an Extension of Class
D and Class E Surface Areas.

* * * * *

ASW OK E4 Fayetteville, AR [Removed]

    Issued in Fort Worth, Texas, on November 26, 2018.
Walter Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2018-26498 Filed 12-7-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: March 10, 2009 (Volume 74, Number 45)]
[Notices]
[Page 10257-10258]
[DOCID:fr10mr09-64]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Oncologic Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 31, 2009, from
8:30 a.m. to 4:30 p.m.
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The hotel telephone number is 301-
589-5200.
    Contact Person: Nicole Vesely, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane,
(for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD
20857,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>or FDA Advisory Committee Information Line,
1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), code
3014512542. Please call the Information Line for up-to-date information
on this meeting. A notice in the Federal Register about last minute
modifications that impact a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the agency's Web site and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
    Agenda: The committee will discuss supplemental biologics license
application (sBLA) 125085/169, AVASTIN (bevacizumab), Genentech, Inc.,
proposed indication as single agent for the treatment of previously
treated glioblastoma multiforme.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2009 and scroll down to the appropriate advisory committee
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
March 20, 2009. Oral presentations from the public will be scheduled
between approximately 1 p.m. to 2 p.m. Those desiring to make formal
oral presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before March 16, 2009. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by March 17,
2009.

    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Nicole Vesely at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: March 4, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-5058 Filed 3-9-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 78, Number 219 (Wednesday, November 13, 2013)]
[Notices]
[Page 68052]
[FR Doc No: 2013-27046]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL14-9-000]

Gregory Swecker, Beverly Swecker; Notice of Petition for
Enforcement

    Take notice that on November 4, 2013, pursuant to section 210(h) of
the Public Utility Regulatory Policies Act of 1978 (PURPA), 16 U.S.C.
824 and Rules 385.26 and 214 of the Rules of Practice and Procedure of
the Federal Energy Regulatory Commission (Commission), Gregory and
Beverly Swecker filed a Petition for Enforcement, requesting the
Commission initiate enforcement action against Midland Power
Cooperative to ensure that PURPA regulations are properly and lawfully
implemented.
    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 online at http://www.ferc.gov, using the
``eLibrary'' link and is 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>.
    Comment Date: 5:00 p.m. Eastern Time on November 25, 2013.

    Dated: November 5, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-27046 Filed 11-12-13; 8:45 am]
BILLING CODE 6717-01-P