[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Rules and Regulations]
[Pages 45697-45701]
[FR Doc No: 2017-20689]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-3697; Product Identifier 2015-NM-143-AD; Amendment
39-19062; AD 2017-20-05]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are superseding Airworthiness Directive (AD) 2011-01-15,
which applied to certain The Boeing Company Model 757-200, -200CB, and
-300 series airplanes. AD 2011-01-15 required repetitive inspections
for cracking of the fuselage skin of the crown skin panel along the
chem-milled step at certain stringers, and repair if necessary. This AD
adds repetitive inspections for cracking in additional areas, and
repair if necessary; removes airplanes from the applicability; adds an
optional skin panel replacement, which terminates all inspections; adds
an optional preventive modification, which terminates certain
inspections; and reduces the compliance time for certain inspections.
This AD was prompted by reports of the initiation of new fatigue
cracking in the fuselage skin of the crown skin panel along locally
thinned channels adjacent to the chem-milled steps. We are issuing this
AD to address the unsafe condition on these products.

DATES: This AD is effective November 6, 2017.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of November 6,
2017.

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; telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
You may view this service information at the FAA, Transport Standards
Branch, 1601 Lind Avenue SW., Renton, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2016-3697.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
3697; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this final rule, the regulatory evaluation, any comments
received, and other information. The address for the Docket Office
(phone:<PHONE_NUMBER>) is Docket Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200

New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Eric Schrieber, Aerospace Engineer,
Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount
Boulevard, Lakewood, CA 90712-4137; phone:<PHONE_NUMBER>; fax: 562-627-
5210; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2011-01-15, Amendment 39-16572 (76 FR 1351,
January 10, 2011) (``AD 2011-01-15''). AD 2011-01-15 applied to certain
The Boeing Company Model 757-200, -200CB, and -300 series airplanes. AD
2011-01-15 required repetitive inspections for cracking of the fuselage
skin of the crown skin panel along the chem-milled step at stringers S-
4L and S-4R, from station (STA) 297 through STA 439, and repair if
necessary. AD 2011-01-15 also included terminating action for the
repetitive inspections of the repaired areas only. AD 2011-01-15
resulted from reports of cracking in the fuselage skin of the crown
skin panel. The NPRM published in the Federal Register on February 18,
2016 (81 FR 8157) (``The NPRM''). The NPRM was prompted by reports of
the initiation of new fatigue cracking in the fuselage skin of the
crown skin panel along locally thinned channels adjacent to the chem-
milled steps. The NPRM proposed to add repetitive inspections for
cracking in additional areas, and repair if necessary. The NPRM also
proposed to remove airplanes from the applicability in AD 2011-01-15.
The NPRM also proposed to add an optional skin panel replacement, which
would terminate all inspections, and an optional preventive
modification, which would terminate certain inspections.
    We issued a supplemental NPRM (SNPRM) that published in the Federal
Register on May 5, 2017 (82 FR 21146). The SNPRM proposed to reduce the
compliance time for certain inspections.
    We are issuing this AD to correct the unsafe condition on these
products.

Comments

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

Supportive Comment

    United Airlines and Boeing concurred with the SNPRM.

Request for Alternative Method of Compliance (AMOC)

    VT Mobile Aerospace Engineering (MAE) Inc. stated that the proposed
AD (in the SNPRM) affects Model 757-200 airplanes that were modified
using certain VT MAE supplemental type certificates (STCs). VT MAE
noted that its design at certain inspection locations is not identical
to that of the Boeing STC design at those locations. Therefore, VT MAE
plans to issue new service information to address the unsafe condition,
and plans to request approval of an AMOC from the FAA for use of the
new service information.
    FedEx stated that its airplanes have been modified in accordance
with the VT MAE STC, and once this AMOC is approved to address this
issue, FedEx will use it to comply with the requirements in the
proposed AD (in the SNPRM).
    We acknowledge the commenters' remarks. Under the provisions of
paragraph (n) of this AD, we will consider requests for approval of an
AMOC that addresses the VT MAE STCs, if appropriate data are submitted
to substantiate that the method would provide an acceptable level of
safety. We have made no change to this AD in this regard.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD as proposed, except for minor editorial changes. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
SNPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the SNPRM.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Special Attention Service Bulletin 757-53-0097,
Revision 3, dated December 2, 2016. This service information describes
procedures for repetitive external sliding probe eddy current (EC) and
external spot-probe-medium-frequency EC inspections for cracking of the
crown skin panel, repair, a preventive modification, and replacement of
the crown skin panel. This service information is reasonably available
because the interested parties have access to it through their normal
course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 652 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
            Action                  Labor cost            Parts cost          Cost per product      operators
----------------------------------------------------------------------------------------------------------------
Inspections (Zone 1) [Retained  2 work-hours x     $0......................  $170 per           $110,840 per
 actions from AD                 $85 per hour =                               inspection cycle.  inspection
 2011[dash]01[dash]15].          $170 per                                                        cycle.
                                 inspection cycle.
Inspections (Zones 2 and 3)     Up to 4 work-      $0......................  Up to $340 per     Up to $221,680
 [new action].                   hours x $85 per                              inspection cycle.  per inspection
                                 hour = Up to                                                    cycle.
                                 $340 per
                                 inspection cycle.
Optional modification.........  Up to 615 work-    Up to $26,496...........  Up to $78,771....  Up to
                                 hours x $85 per                                                 $51,358,692.
                                 hour = Up to
                                 $52,275.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that enables us to provide a
cost estimate for the on-condition actions or the optional replacement
specified in this AD.

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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes to
the Director of the System Oversight Division.

Regulatory Findings

    We have 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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2011-01-15, Amendment 39-16572 (76 FR 1351, January 10, 2011), and
adding the following new AD:

2017-20-05 The Boeing Company: Amendment 39-19062; Docket No. FAA-
2016-3697; Product Identifier 2015-NM-143-AD.

(a) Effective Date

    This AD is effective November 6, 2017.

(b) Affected ADs

    This AD replaces AD 2011-01-15, Amendment 39-16572 (76 FR 1351,
January 10, 2011) (``AD 2011-01-15'').

(c) Applicability

    (1) This AD applies to The Boeing Company Model 757-200 and -300
series airplanes, certificated in any category, as identified in
Boeing Special Attention Service Bulletin 757-53-0097, Revision 3,
dated December 2, 2016.
    (2) Installation of Supplemental Type Certificate (STC)
ST01518SE (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgSTC.nsf/0/38B606833BBD98B386257FAA00602538?OpenDocument&Highlight=st01518se)
does not affect the ability to accomplish the actions required by
this AD. Therefore, for airplanes on which STC ST01518SE is
installed, a ``change in product'' alternative method of compliance
(AMOC) approval request is not necessary to comply with the
requirements of 14 CFR 39.17.

(d) Subject

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

(e) Unsafe Condition

    This AD was prompted by reports of the initiation of fatigue
cracking in the fuselage skin of the crown skin panel along locally
thinned channels adjacent to the chem-milled steps. We are issuing
this AD to detect and correct fatigue cracking of the fuselage skin
of the crown skin panel, which could result in pressure venting and
consequent rapid decompression of the airplane.

(f) Compliance

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

(g) Repetitive Inspections

    Do the applicable inspections required by paragraphs (g)(1),
(g)(2), and (g)(3) of this AD.
    (1) For all airplanes: Within the compliance time specified in
paragraph (h) of this AD, do the Zone 1 inspection specified in
paragraph (g)(1)(i) or (g)(1)(ii) of this AD. Repeat the applicable
Part 1 or Part 2 inspection thereafter at the applicable times
specified in table 1 of paragraph 1.E., ``Compliance,'' of Boeing
Special Attention Service Bulletin 757-53-0097, Revision 3, dated
December 2, 2016. Accomplishing the preventive modification
specified in paragraph (k)(1) of this AD or the replacement
specified in paragraph (k)(2) of this AD terminates the inspections
required by this paragraph.
    (i) Do an external sliding probe eddy current (EC) inspection
for cracking of the crown skin panel in the applicable Zone 1 areas
specified in, and in accordance with, Part 1 of the Accomplishment
Instructions of Boeing Special Attention Service Bulletin 757-53-
0097, Revision 3, dated December 2, 2016.
    (ii) Do an external spot-probe-medium-frequency EC inspection
for cracking of the crown skin panel in the applicable Zone 1 areas
specified in, and in accordance with, Part 2 of the Accomplishment
Instructions of Boeing Special Attention Service Bulletin 757-53-
0097, Revision 3, dated December 2, 2016.
    (2) For airplanes on which any crack is found during any
inspection required by paragraph (g)(1) of this AD; or any repair is
installed that covers any portion of the Zone 1 inspection area
specified in Boeing Special Attention Service Bulletin 757-53-0097,
Revision 3, dated December 2, 2016; or the optional Zone 1
preventive modification specified in paragraph (k)(1) of this AD is
installed: At the applicable time specified in table 2 of paragraph
1.E., ``Compliance,'' of Boeing Special Attention Service Bulletin
757-53-0097, Revision 3, dated December 2, 2016, except as required
by paragraph (l)(1) of this AD: Do the Zone 2 inspection specified
in paragraph (g)(2)(i) or (g)(2)(ii) of this AD. Repeat the
applicable Part 4 or Part 5 inspection thereafter at the applicable
times specified in table 2 of paragraph 1.E., ``Compliance,'' of
Boeing Special Attention Service Bulletin 757-53-0097, Revision 3,
dated December 2, 2016. Accomplishing the replacement specified in
paragraph (k)(2) of this AD terminates the inspections required by
this paragraph.
    (i) Do an external sliding probe EC inspection for cracking of
the crown skin panel in the applicable Zone 2 areas specified in,
and in accordance with, Part 4 of the Accomplishment Instructions of
Boeing Special Attention Service Bulletin 757-53-0097, Revision 3,
dated December 2, 2016.
    (ii) Do an external spot-probe-medium-frequency EC inspection
for cracking of the crown skin panel in the applicable Zone 2 areas
specified in, and in accordance with, Part 5 of the Accomplishment
Instructions of Boeing Special Attention Service Bulletin 757-53-
0097, Revision 3, dated December 2, 2016.
    (3) For airplanes on which any crack is found during any
inspection required by paragraph (g)(1) of this AD; or any repair is
installed that covers any portion of the Zone 1 inspection area
specified in Boeing Special Attention Service Bulletin 757-53-0097,
Revision 3, dated December 2, 2016; or the optional Zone 1
preventive modification specified in paragraph (k)(1) of this AD is
installed: At the applicable time specified in table 3 of paragraph
1.E., ``Compliance,'' of Boeing Special Attention Service Bulletin
757-53-0097, Revision 3, dated December 2, 2016, except as required
by paragraph (l)(1) of this AD, do the Zone 3 inspection specified
in paragraph (g)(3)(i) or (g)(3)(ii) of this AD. Repeat the
applicable Part 6 or Part 7 inspection thereafter at the applicable
times specified in table 3 of paragraph 1.E.,

``Compliance,'' of Boeing Special Attention Service Bulletin 757-53-
0097, Revision 3, dated December 2, 2016. Accomplishing the
replacement specified in paragraph (k)(2) of this AD terminates the
inspections required by this paragraph.
    (i) Do an external sliding probe EC inspection for cracking of
the crown skin panel in the applicable Zone 3 areas specified in,
and in accordance with, Part 6 of the Accomplishment Instructions of
Boeing Special Attention Service Bulletin 757-53-0097, Revision 3,
dated December 2, 2016.
    (ii) Do an external spot-probe-medium-frequency EC inspection
for cracking of the crown skin panel in the applicable Zone 3 areas
specified in, and in accordance with, Part 7 of the Accomplishment
Instructions of Boeing Special Attention Service Bulletin 757-53-
0097, Revision 3, dated December 2, 2016.

(h) Initial Compliance Time for Inspection Required by Paragraph (g)(1)
of This AD

    Within the applicable compliance times specified in paragraphs
(h)(1), (h)(2), (h)(3), and (h)(4) of this AD, whichever occurs
latest: Do the initial inspection required by paragraph (g)(1) of
this AD.
    (1) For all airplanes: Before the accumulation of 15,000 total
flight cycles.
    (2) For airplanes on which an external sliding probe EC
inspection for Zone 1, as specified in Boeing Special Attention
Service Bulletin 757-53-0097, has been done as of the effective date
of this AD: Within 620 flight cycles after accomplishing the most
recent external sliding probe EC inspection for Zone 1.
    (3) For airplanes on which an external spot-probe-medium-
frequency EC inspection for Zone 1, as specified in Boeing Special
Attention Service Bulletin 757-53-0097, has been done as of the
effective date of this AD: Within 200 flight cycles after
accomplishing the most recent external spot-probe-medium-frequency
EC inspection for Zone 1.
    (4) For all airplanes: Within 200 flight cycles or 90 days after
the effective date of this AD, whichever occurs first.

(i) Post-Preventive Modification Supplemental Inspections

    For airplanes on which a preventive modification has been
installed as specified in Part 3 of the Accomplishment Instructions
of Boeing Special Attention Service Bulletin 757-53-0097, Revision
3, dated December 2, 2016: At the applicable time specified in table
4 of paragraph 1.E., ``Compliance,'' of Boeing Special Attention
Service Bulletin 757-53-0097, Revision 3, dated December 2, 2016; do
eddy current and detailed inspections for cracking of the applicable
areas of the fuselage skin of the doublers, triplers, and fillers of
the preventive modification, in accordance with the Accomplishment
Instructions of Boeing Special Attention Service Bulletin 757-53-
0097, Revision 3, dated December 2, 2016. Repeat the inspection
thereafter at the applicable times specified in table 4 of paragraph
1.E., ``Compliance,'' of Boeing Special Attention Service Bulletin
757-53-0097, Revision 3, dated December 2, 2016.

(j) Repair

    If any cracking is found during any inspection required by
paragraph (g)(1), (g)(2), (g)(3), or (i) of this AD, repair before
further flight using a method approved in accordance with the
procedures specified in paragraph (n) of this AD. Doing the repair
ends the repetitive inspections for the repaired area only.

(k) Optional Terminating Actions

    (1) Accomplishing the preventive modification, including doing
high frequency EC open-hole inspections for cracking in the existing
fastener holes, in accordance with Part 3 of the Accomplishment
Instructions of Boeing Special Attention Service Bulletin 757-53-
0097, Revision 3, dated December 2, 2016, except as required by
paragraph (l)(2) of this AD, terminates the inspections required by
paragraph (g)(1) of this AD, provided the preventive modification is
done before further flight after accomplishing an inspection
required by paragraph (g)(1) of this AD. If any cracking is found
during any high frequency EC open-hole inspection, before further
flight, repair using a method approved in accordance with the
procedures specified in paragraph (n) of this AD.
    (2) Replacing the crown skin panel between station (STA) 297 and
STA 439, and stringers S-4L and S-4R, in accordance with the
Accomplishment Instructions of Boeing Special Attention Service
Bulletin 757-53-0097, Revision 3, dated December 2, 2016, or using a
method approved in accordance with the procedures specified in
paragraph (n) of this AD, terminates the inspections required by
paragraphs (g)(1), (g)(2), and (g)(3) of this AD.

(l) Exceptions to Service Information Specifications and Preventive
Modification

    (1) Where Boeing Special Attention Service Bulletin 757-53-0097,
Revision 3, dated December 2, 2016, specifies a compliance time
``after the Revision 2 date of this service bulletin,'' or ``after
the Revision 3 date of this service bulletin,'' this AD requires
compliance within the specified compliance time after the effective
date of this AD.
    (2) Where Boeing Special Attention Service Bulletin 757-53-0097,
Revision 3, dated December 2, 2016, specifies to contact Boeing for
repair instructions: Before further flight, repair using a method
approved in accordance with the procedures specified in paragraph
(n) of this AD.

(m) Credit for Previous Actions

    This paragraph provides credit for Zone 1 inspections required
by paragraph (g)(1) of this AD, if those actions were performed
before the effective date of this AD using Boeing Special Attention
Service Bulletin 757-53-0097, dated November 22, 2010 (which was
incorporated by reference in AD 2011-01-15); Boeing Special
Attention Service Bulletin 757-53-0097, Revision 1, dated January 6,
2011; or Boeing Special Attention Service Bulletin 757-53-0097,
Revision 2, dated July 28, 2015.

(n) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles 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 local Flight Standards
District 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 (o)(1) of this AD. Information
may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Los Angeles ACO Branch, 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.
    (4) AMOCs approved for AD 2011-01-15 are approved as AMOCs for
the corresponding provisions of paragraph (g) of this AD; except, as
of the effective date of this AD, AMOCs that extend the initial
compliance times specified in AD 2011-01-15 are no longer approved
for the compliance time extension, and the compliance times required
by this AD must be complied with.
    (5) For service information that contains steps that are labeled
as Required for Compliance (RC), the provisions of paragraphs
(n)(5)(i) and (n)(5)(ii) apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. An AMOC is required for any deviations to RC steps,
including substeps and identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(o) Related Information

    (1) For more information about this AD, contact Eric Schrieber,
Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch,
3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-
5348; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (p)(3) and (p)(4) of this AD.

(p) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.

    (i) Boeing Special Attention Service Bulletin 757-53-0097,
Revision 3, dated December 2, 2016.
    (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;
telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 1601 Lind Avenue SW., Renton, 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, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on September 14, 2017.
Jeffrey E. Duven,
Director, System Oversight Division, Aircraft Certification Service.
[FR Doc. 2017-20689 Filed 9-29-17; 8:45 am]
 BILLING CODE 4910-13-P


"Marc Melnick"<EMAIL_ADDRESS> 09/28/2007 07:11 PM

To

David Dickinson/DC/USEPA/US@EPA

cc

Subject

EPA-HQ-OAR-2006-0173

Consistent with our earlier submissions, I am enclosing a brief my office filed today in Central Valley Chrysler-Jeep, Inc. v. Witherspoon (U.S.D.C., E.D. Cal., No. 1:04-CV-06663-AWI-NEW (TAG)) regarding the impact of the Supreme Court's Massachusetts v. EPA decision on the preemption claims in the Central Valley case.  As you know, the Central Valley case challenges the same state greenhouse gas emission standards which are involved in this waiver proceeding.

Please do not hesitate to contact me if you have any questions.

Thank you.

Marc N. Melnick

Deputy Attorney General

California Attorney General's Office

    1515 Clay Street  , 20th Floor

    P.O. Box  70550

    Oakland ,   CA     94612

510/622-2133

fax 510/622-2270

<EMAIL_ADDRESS>


[Federal Register Volume 77, Number 156 (Monday, August 13, 2012)]
[Notices]
[Page 48150]
[FR Doc No: 2012-19784]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP12-488-000]

Carolina Gas Transmission Corporation; Notice of Request Under
Blanket Authorization

    Take notice that on July 25, Carolina Gas Transmission Corporation
(Carolina Gas), 601 Old Taylor Road, Cayce, South Carolina 29033, filed
in Docket No. CP12-488-000, an application pursuant to sections 157.205
and 157.210 of the Commission's Regulations under the Natural Gas Act
(NGA) as amended, to convert three existing standby compressor units at
its Grover Compressor Station in Cherokee County, South Carolina, to
base load service under Carolina Gas' blanket certificate issued in
Docket Nos. CP06-71-000 et al.,\1\ all as more fully set forth in the
application which is on file with the Commission and open to the public
for inspection.
---------------------------------------------------------------------------

    \1\ 116 FERC ] 61,049 (2006).
---------------------------------------------------------------------------

    Carolina Gas proposes to convert three existing standby 1,050
horsepower (HP) Solar Saturn turbine compressor units to base load
service at the Grover Compressor Station. Carolina Gas states that it
would convert the three standby compressor units to base load service
in order to provide additional firm transportation capacity to three
customers who have requested additional capacity on Carolina Gas'
system. Carolina Gas also states that no construction, abandonment, or
earth disturbance would be involved with this proposal. Carolina Gas
estimates that the proposed compressor conversions would cost $85,000
to implement.
    Any questions concerning this application may be directed to Randy
D. Traylor, Jr., Manager--System Planning, Carolina Gas Transmission
Corporation, 601 Old Taylor Road, Cayce, South Carolina 29033,
telephone<PHONE_NUMBER>, or by Email<EMAIL_ADDRESS>    This filing is available for review at the Commission or may be
viewed on the Commission's Web site at http://www.ferc.gov, using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number filed to access the document. For
assistance, please contact FERC Online Support at FERC
<EMAIL_ADDRESS>or call toll-free at<PHONE_NUMBER>, or, for
TTY, contact<PHONE_NUMBER>. Comments, protests and interventions may
be filed electronically via the Internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
intervenors to file electronically.
    Any person or the Commission's staff may, within 60 days after
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and pursuant to Section 157.205 of
the regulations under the NGA (18 CFR 157.205), a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for filing a protest. If a protest is filed and
not withdrawn within 30 days after the allowed time for filing a
protest, the instant request shall be treated as an application for
authorization pursuant to Section 7 of the NGA.

    Dated: August 7, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-19784 Filed 8-10-12; 8:45 am]
BILLING CODE 6717-01-P


	APPA's Timeline of Major EPA Regulations

 04/05/2011 11:41 AM

Fro	From:  "Stowe, Monica"<EMAIL_ADDRESS>Sort List...

To:	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><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><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>RobertJ Wayland/RTP/USEPA/US@EPA, Christian Fellner/RTP/USEPA/US@EPA, Lanelle Wiggins/DC/USEPA/US@EPA, Alexander Cristofaro/DC/USEPA/US@EPA, <EMAIL_ADDRESS><EMAIL_ADDRESS>"Pugh, Theresa" <EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Nick Hutson/RTP/USEPA/US@EPA, Larry Sorrels/RTP/USEPA/US@EPA, Scott Jordan/DC/USEPA/US@EPA, <EMAIL_ADDRESS><EMAIL_ADDRESS>Mary Johnson/RTP/USEPA/US@EPA

	Cc:	Cc:  "Pugh, Theresa"<EMAIL_ADDRESS>

	All,

Per the request of Theresa Pugh, APPA’s Environmental Director, attached is the most up to date timeline of major EPA regulations.  Below please find a link to APPA’s NSPS comments to the EPA that were prepared for the March 18th deadline.  Please contact Theresa (  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>) or myself if you have any questions.

  HYPERLINK "http://www.publicpower.org/files/PDFs/APPAcomments_EPAHQOAR20110090.pdf "  http://www.publicpower.org/files/PDFs/APPAcomments_EPAHQOAR20110090.pdf

Monica Stowe

Environment & Engineering Assistant

American Public Power Association

1875 Connecticut Ave., NW

Suite 1200

Washington D.C. 20009

(202) 467-2942 (phone)

(202) 495-7442 (fax)

<EMAIL_ADDRESS>

  HYPERLINK "http://www.publicpower.org/"  www.PublicPower.org

Please note APPA’s new website URL and my new e-mail address.

Make the most of your time at the 2011 National Conference & Public Power Expo.

  HYPERLINK "http://www.publicpower.org/NationalConference/ConferenceProgram/content .cfm?ItemNumber=29909"  Attend a pre-conference seminar.

CornWreck Theresa Updated 3 11.pdf


                               Site Visit Report

	El Segundo Generating Station
      301 Vista Del Mar
      El Segundo, CA 90245
      September 1, 2009

1.0 Background and Objectives

The Environmental Protection Agency (EPA) is in the process of developing 316(b) cooling water intake structure requirements that reflect the best technology available (BTA) for minimizing adverse environmental impact for all existing power plants and manufacturing facilities.  As part of this process, EPA staff is visiting electric generators and manufacturers to better understand the cooling water intake structure (CWIS) technologies in use at facilities, including the site-specific characteristics of each facility and how these affect the selection and performance of CWIS technologies.  EPA is also visiting facilities to better understand cooling water use and specific issues or technologies that can affect 316(b) compliance.  EPA selected El Segundo Generating Station (El Segundo) for a site visit due to its ocean withdrawal location and to understand its repowering project in relation to cooling water needs.

2.0 Facility Description

      El Segundo occupies approximately 22 acres of a 33 acre oceanside site in the City of El Segundo and began operations in the 1950s.  The facility is located immediately adjacent to Dockweiler and Manhattan State Beaches (to the west and north).  Residential areas of the City of Manhattan Beach adjoin the property's southern boundary, while a portion of a refinery lies to the east.  The area is fairly hilly, with the facility's switchyard located at an elevation several dozen feet above the generating units.  See Attachment B for an aerial view.

      The facility is owned by El Segundo Power (a subsidiary of NRG).  The facility's NPDES permit (CA0001147) expired May 10, 2005 and has been administratively extended pending renewal.

3.0 Electricity Generation and Transmission

      El Segundo currently operates 2 natural gas-fired generating units (Units 3 and 4), which have a combined generating capacity of 670 MW.  These units began operation in 1964 and 1965, respectively.   Units 1 and 2 were retired in 2002 and are being repowered.  (See Section 8.0 for more information.)  Units 3 and 4 have historically had high capacity utilization rates, but have dropped to approximately 10% in recent years.

      The switchyard is owned by Southern California Edison.

4.0 Cooling Water System and Intake Structure

      The facility currently operates one offshore CWIS.  The CWIS is comprised of a pipe located approximately 2600 feet offshore at a depth of 27 feet fitted with a velocity cap.  Water is withdrawn from Santa Monica Bay through the velocity cap (which is fitted with marine mammal exclusion bars) to a forebay onshore with a trash rack and 4 intake bays with one coarse mesh (5/8") traveling screen each.  Screens are washed twice per day or as needed, based on the head differential across the screen.  Materials and fish removed from the screens are disposed in the landfill.  The design through-screen velocity at the traveling screens is 2.0 feet per second (fps).

      The design intake flow (DIF) for El Segundo is 399 million gallons per day (mgd).

      El Segundo uses both biocides and heat treatment for biofouling control.  Sodium hypochlorite injection is used three times per day for 40 minutes each.  Approximately every 6 weeks, the facility closes its discharge tunnel and recirculates the cooling water; it reaches approximately 125°F and serves to remove colonial organisms.

      The facility's discharge point is also offshore, at a distance of about 2100 feet.

5.0 Impingement and Entrainment Information

      El Segundo conducted impingement mortality and entrainment monitoring in 2006 and submitted a report to the state in January 2008.  The sampling program included fish, invertebrates and crustaceans, and looked at various life stages of each.  Two sampling stations recorded entrainment data, with ten additional stations serving as the source water control stations.  In 12 entrainment sampling events (collected samples every 6 hours in a 24 hour period) representing normal operations, 420,000 larvae (in 66 taxa), 570,000 eggs, and 431 larval shellfish were collected.

      Impingement was recorded during 12 (one per month) events, plus an additional 4 collections during heat treatments.  During normal operations, 22 fish (9 species) were collected, with no species being numerically dominant.  During heat treatments, 916 fish (45 species) were collected.  The total estimated annual impingement was 1527 fish.  The study concluded that there is no adverse environmental impact occurring as a result of the operation of the El Segundo facility.

6.0 Cooling Tower Feasibility

      Facility representatives noted that El Segundo is located on a compact, urban site.  As explained in Section 2.0, the facility is bordered by city streets and state beaches on either side.  Residential areas and an adjacent refinery also limit available space nearby.  El Segundo is also located approximately 2 miles away from Los Angeles International Airport.

      Materials provided by the facility estimated that a retrofit to wet or dry cooling would cost between $100-115 million.

      El Segundo, along with all other coastal once-through cooling facilities in California, was recent evaluated by the State Water Resources Control Board as to the potential to retrofit the facility to closed-cycle cooling. A report prepared for the California Ocean Protection Council (OPC) and State Water Board in 2008 identified several obstacles that would likely influence the feasibility of cooling towers at El Segundo: the compactness of the site, the likely need for plume abatement, and the proximity of residential areas.  Because of these obstacles, the report concluded that a retrofit to closed-cycle cooling was not feasible at El Segundo.

7.0 Debris Handling

      Facility representatives did not identify any significant problems with debris.

8.0 Repowering/Future Uses

Units 1 and 2 will be demolished and the new Units 5 and 7 (combined cycle) built in their place.  The new units will be more efficient and flexible than the retired units allowing the facility to better respond to peak and load-based demand and have a combined generating capacity of 560 MW.  The original design for the new units called for a once-through cooling system, but the facility amended its design to utilize a closed-cycle dry cooling system.  Facility representatives noted that multiple factors influenced their decision to move towards dry cooling:  financing for dry cooling was easier to obtain at the time of the design, they preferred the design over other tower designs, dry cooling would allow them to eliminate their NPDES permit, and dry cooling offered a greater degree of permitting certainty.  In particular, facility representatives noted that an ongoing legal battle over the availability of emission credits within the South Coast Air Quality Management District has raised the possibility that no new projects would be able to obtain the necessary air permits, including facilities repowering with wet cooling towers.   In selecting dry cooling, El Segundo is eliminating approximately 200 mgd of water withdrawals.
The repowering project is currently scheduled for completion in June 2011.  However, facility representatives noted they are currently behind schedule for constructing the new units, as permitting delays (related to air emissions permits) have caused delays.
      Facility representatives stated that they are open to the concept of repowering Unit 3 and 4, but that no plans are currently being made.

9.0 Cooling Ponds

      There are no cooling ponds onsite.

10.0 Ownership

      El Segundo is owned by NRG Energy, an investor-owned company.

11.0 316(a)

      EPA did not collect any information regarding El Segundo's thermal discharge.

12.0 Ash Handling

      El Segundo does not use coal as a fuel and therefore has no ash ponds.

13.0 Air Emissions Controls

      EPA did not collect any information regarding air emissions controls.

14.0 Additional Information

      Facility representatives stated that they had not reached a definitive response for complying with the now-suspended 2004 Phase II rule.  Facility representatives indicated they likely would have pursued repowering, as retrofitting cooling towers to a facility with a low utilization rate does not make sense.

      Facility representatives noted that the Long Beach power plant has also repowered and eliminated its once-through cooling.  The existing cooling system had too many leaks and was replaced with dry cooling.

Attachments

Attachment A		List of Attendees
Attachment B		Aerial Photos
Attachment C	PowerPoint presentation "El Segundo Power Redevelopment Project" (September 1, 2009)

Attachment A--List of Attendees

Paul Shriner, EPA
Jan Matuszko, EPA
John Kemmerer, EPA Region IX
Tim Havey, Tetra Tech
Kelly Meadows, Tetra Tech
George Piantka, NRG
Alex Sanchez, NRG

Attachment B--Aerial Photo

Please see DCN 10-6552A accompanying this document.

Attachment C -- PowerPoint presentation "El Segundo Power Redevelopment Project" (September 1, 2009)

Please see DCN 10-6552B accompanying this document.


[Federal Register Volume 82, Number 123 (Wednesday, June 28, 2017)]
[Notices]
[Page 29301]
[FR Doc No: 2017-13558]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2017-0010; OMB No. 1660-0047]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; Request for Federal Assistance Form--How To
Process Mission Assignments in Federal Disaster Operations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

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

DATES: Comments must be submitted on or before July 28, 2017.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the Desk
Officer for the Department of Homeland Security, Federal Emergency
Management Agency, and sent via electronic mail to
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Patricia
Pritchett, Program Specialist, Response Directorate, Operations
Division, National Response Coordination Center, Federal Emergency
Management Agency,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This information collection previously
published in the Federal Register on March 29, 2017, at 82 FR 15531,
with a 60 day comment period. No comments were received. This
information collection expired on May 31, 2017. FEMA is requesting a
reinstatement of the collection with change. The changes include an
increase in annual burden hours due to the addition of new FEMA Form
010-0-8A, Mission Assignment Task Order. The purpose of this notice is
to inform the public that FEMA will submit the information collection
abstracted below to the Office of Management and Budget for
reinstatement and clearance.

Collection of Information

    Title: Request for Federal Assistance Form--How to Process Mission
Assignments in Federal Disaster Operations.
    Type of Information Collection: Reinstatement, with change, of a
previously approved information collection for which approval has
expired.
    OMB Number: 1660-0047.
    Form Titles and Numbers: FEMA Form 010-0-7, Resource Request Form;
FEMA Form 010-0-8, Mission Assignment; FEMA Form 010-0-8A, Mission
Assignment Task Order.
    Abstract: If a State determines that its capacity to respond to a
disaster exceeds its available resources, it may submit to FEMA a
request that the work be accomplished by a Federal agency. This request
documents how the response requirements exceed the capacity for the
State to respond to the situation on its own and what type of
assistance is required. FEMA reviews this information and may issue a
mission assignment to the appropriate Federal agency to assist the
State in its response to the situation.
    Affected Public: State, local or Tribal Government.
    Number of Respondents: 10.
    Estimated Total Annual Burden Hours: 6,559 hours.
    Estimated Cost: The estimated annual cost to respondents for the
hour burden is $446,144. There are no annual costs to respondents
operations and maintenance costs for technical services. There are no
annual start-up or capital costs. The cost to the Federal Government is
$28,309.27.

    Dated: June 22, 2017.
Richard Mattison,
Records Management Program Chief, Mission Support, Federal Emergency
Management Agency, Department of Homeland Security.
[FR Doc. 2017-13558 Filed 6-27-17; 8:45 am]
 BILLING CODE 9110-24-P


[Federal Register Volume 82, Number 141 (Tuesday, July 25, 2017)]
[Notices]
[Pages 34548-34549]
[FR Doc No: 2017-15576]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2017-0017; OMB No. 1660-0135]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; Staffing for Adequate Fire and Emergency
Response (SAFER) Grants

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice and request for comments.

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

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

DATES: Comments must be submitted on or before August 24, 2017.

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

copies of the information collection should be made to Director,
Records Management Division, 500 C Street SW., Washington, DC 20472-
3100, or email address<EMAIL_ADDRESS>Or, William Dunham, Fire Program Specialist,
FEMA, Grant Program Directorate,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This proposed information collection
previously published in the Federal Register on May 12, 2017 at 82 FR
22150 with a 60-day public comment period. FEMA received two positive
comments supporting FEMA's effort to continue SAFER grants for both
fire departments and the communities they serve, but one provided a
caveat to streamline the process. FEMA's response is that the Program
Office is working towards this goal. FEMA received one comment that
application material were difficult to locate at this time. FEMA's
response is that the materials are only available during the
application period, applicants are notified well ahead of time through
the Notice of Funding Opportunity of these dates. The purpose of this
notice is to notify the public that FEMA will submit the information
collection abstracted below to the Office of Management and Budget for
review and clearance.

Collection of Information

    Title: Staffing for Adequate Fire and Emergency Response (SAFER)
Grants.
    Type of Information Collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0135.
    Form Titles and Numbers: FEMA Form 080-0-4, Staffing for Adequate
Fire and Emergency Response (SAFER) (General Questions All Applicants);
FEMA Form 080-0-4a, Staffing for Adequate Fire and Emergency Response
Hiring of Firefighters Application (Questions and Narrative); FEMA Form
080-0-4b, Staffing for Adequate Fire and Emergency Response Recruitment
and Retention of Volunteer Firefighters Application (Questions and
Narrative); FEMA Form 087-0-0-2, Staffing for Adequate Fire and
Emergency Response Quarterly Report and Payment Request Form.
    Abstract: FEMA uses this information to ensure that FEMA's
responsibilities under the legislation can be fulfilled accurately and
efficiently. The information will be used to objectively evaluate each
of the anticipated applicants to determine which of the applicants'
proposals in each of the activities are the closest to the established
program priorities.
    Affected Public: State, Local or Tribal Government; Not-for-Profit
Institutions.
    Estimated Number of Respondents: 2,330.
    Estimated Number of Responses: 2,990.
    Estimated Total Annual Burden Hours: 18,064 hours.
    Estimated Total Annual Respondent Cost: $984,437.20.
    Estimated Respondents' Operation and Maintenance Costs: None.
    Estimated Respondents' Capital and Start-Up Costs: None.
    Estimated Total Annual Cost to the Federal Government:
$1,666,213.80.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

    Dated: July 19, 2017.
Tammi Hines,
Acting Records Management Program Chief, Mission Support, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2017-15576 Filed 7-24-17; 8:45 am]
 BILLING CODE 9111-46-P


Draft, 4/ 12/ 05; subject to change 1 1 Dental Facilities Industry Profile Dental facilities include facilities in SIC Code 8021, Offices and Clinics of Dentists. The 1987 SIC Code Manual defines SIC Code 8021 as follows:

This industry comprises establishments of health practitioners having the degree of D. M. D. ( Doctor of dental medicine), D. D. S. ( Doctor of dental surgery), or D. D. Sc. ( Doctor of dental science) primarily engaged in the independent practice of general or specialized dentistry or dental surgery. These practitioners operate private or group practices in their own offices ( e. g., centers, clinics) or in the facilities of others, such as hospitals or HMO medical centers. They can provide either comprehensive preventive, cosmetic, or emergency care, or specialize in a single field of dentistry.

Table 1 1. Census Data SIC Code NAICS Code Number of Facilities in 1997 8021 : Offices and Clinics of Dentists 6212: Offices of Dentists 114,178 Table 1 2 shows the facility counts available from TRI and PCS.

Table 1 2. Facility Counts SIC Code Number of Facilities Reporting to 2000 TRI Number of Facilities Reporting to PCS ( Minors) Direct Only Indirect Only Both No Water Discharge Reported 8021 0 0 0 0 2 a. Wastewater Characteristics . Wastewater Quantity Table 1 3 summarizes the wastewater flow data available in the 2000 PCS database. No facilities reported to the 2000 TRI. Draft, 4/ 12/ 05; subject to change 1 2 Table 1 3. Wastewater Flow Data from PCSLoads2000 SIC NPDES ID Flow, MGY 8021 FL0033154 0.120 8021 MD0053155 1.43 . Raw and Treated Wastewater Quality Almost all dental facilities discharge to POTWs. Of the 114,178 facilities in the 1997 Census, only 2 appear in the PCS database, both of which are minor discharges. Table 1 4 lists the facilities noted as SIC Code 8021 in the 2000 PCS database. By name, both appear to be treatment plants, not dental facilities.

Table 1 4. List of Facilities in PCSLoads2000 SIC Name City NPID Major/ Minor 8021 Oak Lane Building Sewage Treatment Plant Jacksonville FL0033154 Minor 8021 Thunderbird Motel WWTP Newburg MD0053155 Minor a. On Site Wastewater Treatment/ Pretreatment Dental facility pretreatment usually includes:

Silver recovery for X ray wastes and

Simple drain traps in patient chair side sinks to recover solid particles of amalgam and other tissue.


[Federal Register Volume 77, Number 137 (Tuesday, July 17, 2012)]
[Notices]
[Pages 41984-41985]
[FR Doc No: 2012-17369]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0708]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Form FDA 3728, Animal
Generic Drug User Fee Act Cover Sheet

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Fax written comments on the collection of information by August
16, 2012.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs,

OMB, Attn: FDA Desk Officer, FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All comments should be identified with the OMB
control number 0910-0632. Also include the FDA docket number found in
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley II, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Form FDA 3728, Animal Generic Drug User Fee Act Cover Sheet--21 U.S.C.
379j-21 (OMB Control Number 0910-0632)--Extension

    Section 741 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 379j-21) establishes three different kinds of user fees: (1)
Fees for certain types of abbreviated applications for generic new
animal drugs, (2) annual fees for certain generic new animal drug
products, and (3) annual fees for certain sponsors of abbreviated
applications for generic new animal drugs and/or investigational
submissions for generic new animal drugs (21 U.S.C. 379j-21(a)).
Because the submission of user fees concurrent with applications is
required, the review of an application cannot begin until the fee is
submitted. Form FDA 3728 is the Animal Generic Drug User Fee Act
(AGDUFA) Cover Sheet, which is designed to provide the minimum
necessary information to determine whether a fee is required for review
of an application, to determine the amount of the fee required, and to
account for and track user fees.
    In the Federal Register of October 5, 2011 (76 FR 61709), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                     FDA Form Number                           Number of        responses per       Total annual      Average burden      Total hours
                                                              respondents         respondent         responses         per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
3728.....................................................                20                  2                 40       .08 (5 min.)                3.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Respondents to this collection of information are generic animal
drug applicants. Based on FDA's database system, there are an estimated
20 sponsors of new animal drugs potentially subject to AGDUFA.

    Dated: July 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17369 Filed 7-16-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 109 (Wednesday, June 7, 2023)]
[Notices]
[Pages 37286-37287]
[FR Doc No: 2023-12153]

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

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2013-0016]

Nemko North America, Inc.: Application for Expansion of
Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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

SUMMARY: In this notice, OSHA announces the application of Nemko North
America, Inc., for expansion of the recognition as a Nationally
Recognized Testing Laboratory (NRTL) and presents the agency's
preliminary finding to grant the application.

DATES: Submit comments, information, and documents in response to this
notice, or requests for an extension of time to make a submission, on
or before June 22, 2023.

ADDRESSES: Submit comments by any of the following methods:
    Electronically: Submit comments and attachments electronically at
http://www.regulations.gov, which is the Federal eRulemaking Portal.
Follow the instructions online for making electronic submissions.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Instructions: All submissions must include the agency name and the
OSHA docket number (OSHA-2013-0016). OSHA places comments and other
materials, including any personal information, in the public docket
without revision, and these materials will be available online at
http://www.regulations.gov. Therefore, the agency cautions commenters
about submitting statements they do not want made available to the
public, or submitting comments that contain personal information
(either about themselves or others) such as Social Security numbers,
birth dates, and medical data.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office. All
documents in the docket (including this Federal Register notice) are
listed in the http://www.regulations.gov index; however, some
information (e.g., copyrighted material) is not publicly available to
read or download through the website. All submissions, including
copyrighted material, are available for inspection through the OSHA
Docket Office. Contact the OSHA Docket Office at<PHONE_NUMBER> (TTY
(877) 889-5627) for assistance in locating docket submissions.
    Extension of comment period: Submit requests for an extension of
the comment period on or before June 22, 2023 to the Office of
Technical Programs and Coordination Activities, Directorate of
Technical Support and Emergency Management, Occupational Safety and
Health Administration, U.S. Department of Labor, 200 Constitution
Avenue NW, Room N-3653, Washington, DC 20210, or by fax to (202) 693-
1644.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, phone:<PHONE_NUMBER> or email:
[email protected].
    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, phone:<PHONE_NUMBER> or email:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Notice of the Application for Expansion

    OSHA is providing notice that Nemko North America, Inc. (NNA), is
applying for expansion of the current recognition as a NRTL. NNA
requests the addition of eight test standards to the NRTL scope of
recognition.
    OSHA recognition of a NRTL signifies that the organization meets
the requirements specified in 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within the
scope of recognition. Each NRTL's scope of recognition includes: (1)
the type of products the NRTL may test, with each type specified by the
applicable test standard; and (2) the recognized site(s) that has/have
the technical capability to perform the product-testing and product-
certification activities for test standards within the NRTL's scope.
Recognition is not a delegation or grant of government authority;
however, recognition enables employers to use products approved by the
NRTL to meet OSHA standards that require product testing and
certification.
    The agency processes applications by a NRTL for initial recognition
and for an expansion or renewal of this recognition, following
requirements in Appendix A to 29 CFR 1910.7. This appendix requires
that the agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides a preliminary finding. In the second notice,
the agency provides a final decision on the application. These notices
set forth the NRTL's scope of recognition or modifications of that
scope. OSHA maintains an informational web page for each NRTL,
including NNA, which details the NRTL's scope of recognition. These
pages are available from the OSHA website at http://www.osha.gov/dts/otpca/nrtl/index.html.
    NNA currently has two facilities (sites) recognized by OSHA for
product testing and certification, with the

headquarters located at: Nemko North America, Inc., 303 River Road,
Ottawa, Ontario K1V 1H2 Canada. A complete list of NNA's scope of
recognition is available at https://www.osha.gov/nationally-recognized-testing-laboratory-program/ccl.

II. General Background on the Application

    NNA submitted an application on October 14, 2020 (OSHA-2013-0016-
0019), to expand the recognition to include ten additional test
standards. This application was revised on January 18, 2022, to remove
two standards from the original request. This expansion covers the
remaining eight standards. OSHA staff performed a detailed analysis of
the application packet and reviewed other pertinent information. OSHA
did not perform any on-site reviews in relation to this application.
    Table 1, below, lists the appropriate test standards found in NNA's
application for expansion for testing and certification of products
under the NRTL Program.

  Table 1--Proposed Appropriate Tests Standards for Inclusion in NNA's
                        NRTL Scope of Recognition
------------------------------------------------------------------------
        Test standard                     Test standard title
------------------------------------------------------------------------
UL 61010-2-010..............  Safety Requirements for Electrical
                               Equipment for Measurement, Control and
                               Laboratory Use--Part 2-010: Particular
                               Requirements for Laboratory Equipment for
                               the Heating of Materials.
UL 61010-2-020..............  Safety Requirements for Electrical
                               Equipment for Measurement, Control and
                               Laboratory Use--Part 2-020: Particular
                               Requirements for Laboratory Centrifuges.
UL 61010-2-091..............  Safety Requirements for Electrical
                               Equipment for Measurement, Control and
                               Laboratory Use--Part 2-091: Particular
                               Requirements for Cabinet X-Ray Systems.
UL 61010-2-030..............  Safety Requirements for Electrical
                               Equipment for Measurement, Control and
                               Laboratory Use--Part 2-030: Particular
                               Requirements for Equipment Having Testing
                               or Measuring Circuits.
UL 61010-031................  Safety Requirements for Electrical
                               Equipment for Measurement, Control and
                               Laboratory Use--Part 031: Safety
                               Requirements for Hand-Held and Hand-
                               Manipulated Probe Assemblies for
                               Electrical Test and Measurement.
UL 61010-2-051..............  Safety Requirements for Electrical
                               Equipment for Measurement, Control and
                               Laboratory Use--Part 2-051: Particular
                               Requirements for Laboratory Equipment for
                               Mixing and Stirring.
UL 61010-2-081..............  Safety Requirements for Electrical
                               Equipment for Measurement, Control and
                               Laboratory Use--Part 2-081: Particular
                               Requirements for Automatic and Semi-
                               Automatic Laboratory Equipment for
                               Analysis and Other Purposes.
UL 61010-2-101..............  Safety Requirements for Electrical
                               Equipment for Measurement, Control and
                               Laboratory Use--Part 2-101: Particular
                               Requirements for In Vitro Diagnostic
                               (IVD) Medical Equipment.
------------------------------------------------------------------------

III. Preliminary Findings on the Application

    NNA submitted an acceptable application for expansion of the scope
of recognition. OSHA's review of the application file, and pertinent
documentation, indicates that NNA has met the requirements prescribed
by 29 CFR 1910.7 for expanding the recognition to include the addition
of the eight test standards for NRTL testing and certification listed
in Table 1. This preliminary finding does not constitute an interim or
temporary approval of NNA's application.

IV. Public Participation

    OSHA welcomes public comment as to whether NNA meets the
requirements of 29 CFR 1910.7 for expansion of recognition as a NRTL.
Comments should consist of pertinent written documents and exhibits.
    Commenters needing more time to comment must submit a request in
writing, stating the reasons for the request by the due date for
comments. OSHA will limit any extension to 10 days unless the requester
justifies a longer time period. OSHA may deny a request for an
extension if it is not adequately justified.
    To review copies of the exhibits identified in this notice, as well
as comments submitted to the docket, contact the Docket Office,
Occupational Safety and Health Administration, U.S. Department of
Labor. These materials also are generally available online at https://www.regulations.gov under Docket No. OSHA-2013-0016 (for further
information, see the ``Docket'' heading in the section of this notice
titled ADDRESSES).
    OSHA staff will review all comments to the docket submitted in a
timely manner. After addressing the issues raised by these comments,
staff will make a recommendation to the Assistant Secretary of Labor
for Occupational Safety and Health on whether to grant NNA's
application for expansion of the scope of recognition. The Assistant
Secretary will make the final decision on granting the application. In
making this decision, the Assistant Secretary may undertake other
proceedings prescribed in Appendix A to 29 CFR 1910.7.
    OSHA will publish a public notice of the final decision in the
Federal Register.

V. Authority and Signature

    James S. Frederick, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, authorized the preparation of this
notice. Accordingly, the agency is issuing this notice pursuant to 29
U.S.C. 657(g)(2), Secretary of Labor's Order No. 8-2020 (85 FR 58393,
Sept. 18, 2020), and 29 CFR 1910.7.

    Signed at Washington, DC, on May 26, 2023.
James S. Frederick,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2023-12153 Filed 6-6-23; 8:45 am]
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[Federal Register: December 17, 2008 (Volume 73, Number 243)]
[Rules and Regulations]
[Page 76519-76520]
[DOCID:fr17de08-5]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-0986; Airspace Docket No. 08-ASO-15]

Modification of Class E Airspace; Franklin, NC

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Direct final rule, request for comments.

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

SUMMARY: This action modifies the Class E Airspace at Franklin, NC to
include the controlled airspace that is needed to support new Area
Navigation (RNAV) Global Positioning System (GPS) Standard Instrument
Approach Procedures (SIAPs) that has been developed for Macon County
Airport. As a result, controlled airspace extending upward from 700
feet Above Ground Level (AGL) is needed to contain the SIAP and for
Instrument Flight Rule (IFR) operations at Macon County Airport. The
operating status of the airport will change from Visual Flight Rules
(VFR) to include IFR operations concurrent with the publication of the
SIAP. This action enhances the safety and management of IFR operations
in the area by providing the required controlled airspace to support
the SIAPs at Franklin, NC.

DATES: Effective 0901 UTC, March 12, 2009. 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 7400.9 and publication of conforming amendments. Comments for
inclusion in the Rules Docket must be received on or before February 2,
2009.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001;
Telephone: 1-800-647-5527; Fax:<PHONE_NUMBER>. You must identify the
Docket Number FAA-2008-0986; Airspace Docket No. 08-ASO-15, at the
beginning of your comments. You may also submit and review received
comments through the Internet at http://www.regulations.gov.
    You may review the public docket containing the rule, any comments
received, and any final disposition in person in the Dockets Office
(see ADDRESSES section for address and phone number) between 9 a.m. and
5 p.m., Monday through Friday, except Federal Holidays. An informal
docket may also be examined during normal business hours at the office
of the Eastern Service Center, Federal Aviation Administration, Room
210, 1701 Columbia Avenue, College Park, Georgia 30337.

FOR FURTHER INFORMATION CONTACT: Melinda Giddens, Operations Support
Group, Federal Aviation Administration, P.O. Box 20636, Atlanta,
Georgia 30320; Telephone<PHONE_NUMBER>, Fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

The Direct Final Rule Procedure

    The FAA anticipates that this regulation will not result in adverse
or negative comments, and, therefore, issues it as a direct final rule.
The FAA has determined that this rule only involves an established body
of technical regulations for which frequent and routine amendments are
necessary to keep them operationally current. Unless a written adverse
or negative comment or a written notice of intent to submit an adverse
or negative comment is received within the comment period, the
regulation will become effective on the date specified above. After the
close of the comment period, the FAA will publish a document in the
Federal Register indicating that no adverse or negative comments were
received and confirming the effective date. If the FAA receives, within
the comment period, an adverse or negative comment, or written notice
of intent to submit such a comment, a document withdrawing the direct
final rule will be published in the Federal Register, and a notice of
proposed rulemaking may be published with a new comment period.

Comments Invited

    Although this action is in the form of a direct final rule, and was
not preceded by a notice of proposed rulemaking, interested persons are
invited to comment on this rule by submitting such written data, views,
or arguments as they may desire. The direct final rule is used in this
case to facilitate the timing of the charting schedule and enhance the
operation at the airport, while still allowing and requesting public
comment on this rulemaking action. An electronic copy of this document
may be downloaded from and comments submitted through http://
www.regulations.gov. Communications should identify both docket numbers
and be submitted in triplicate to the address specified under the
caption ADDRESSES above or through the Web site. All communications
received on or before the closing date for comments will be considered,
and this rule may be amended or withdrawn in light of the comments
received. Recently published rulemaking documents can also be accessed
through the FAA's Web page at http://www.faa.gov. Recently published
rulemaking documents can also be accessed through the FAA's Web page at
http://www.faa.gov/airports_airtraffic/air_traffic/publications/
airspace_amendments/.
    Comments are specifically invited on the overall regulatory,
economic, environmental, and energy aspects of the rule that might
suggest a need to modify the rule. Factual information that supports
the commenter's ideas and suggestions is extremely helpful in
evaluating the effectiveness of this action and determining whether
additional rulemaking action would be needed. All comments submitted
will be available, both before and after the closing date for comments,
in the Rules Docket for examination by interested persons. Those
wishing the FAA to acknowledge receipt of their comments submitted in
response to this rule must submit a self-addressed, stamped postcard on
which the following

statement is made: ``Comments to Docket No. FAA-2008-0986; Airspace
Docket No. 08-ASO-15.'' The postcard will be date stamped and returned
to the commenter.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 modifies Class E5 airspace at Franklin, NC, to provide the
controlled airspace that is required to support the Area Navigation
(RNAV) Global Positioning System (GPS) Standard Instrument Approach
Procedures (SIAPs) that have been developed for Macon County Airport.
Class E airspace designations for airspace areas extending upward from
700 feet or more above the surface of the Earth are published in
Paragraph 6005 of FAA Order 7400.9S, signed October 3, 2008, and
effective October 31, 2008, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designation listed in this document
would be published subsequently in the Order.

Agency Findings

    The regulations adopted herein will not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among various levels of government. Therefore, it is
determined that this final rule does not have federalism implications
under Executive Order 13132.
    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 will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
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 controlled airspace at Franklin, NC.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of the Amendment

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

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9S, Airspace Designations and Reporting
Points, signed October 3, 2008, effective October 31, 2008, is amended
as follows:

Paragraph 6005 Class E Airspace Designated as Surface Areas.

* * * * *

ASO NC E5 Franklin, NC [Amended]

Macon County Airport,
    (Lat. 35[deg]13'21'' N., long 83[deg]25'09'' W.)

Angel Medical Center, Franklin, NC Point In Space Coordinates
    (Lat. 35[deg]10'37'' N., long 83[deg]22'04'' W.)

    That airspace extending upward from 700 feet or more above the
surface of the Earth within a 6.4-mile radius of Macon County
Airport and that airspace within a 6-mile radius of the Point in
Space Coordinates (Lat. 35[deg]10'37'' N., Long. 83[deg]22'04'' W.)
serving the Angel Medical Center.
* * * * *

    Issued in College Park, Georgia, on November 20, 2008.
Barry A. Knight,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. E8-29753 Filed 12-16-08; 8:45 am]

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[Federal Register Volume 79, Number 157 (Thursday, August 14, 2014)]
[Notices]
[Page 47654]
[FR Doc No: 2014-19261]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0622]

Draft Guidance for Industry on Best Practices in Developing
Proprietary Names for Drugs; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is reopening the
comment period for the draft guidance entitled ``Best Practices in
Developing Proprietary Names for Drugs,'' which published in the
Federal Register of May 29, 2014 (79 FR 30852). FDA is reopening the
comment period in response to several requests for additional time and
to allow interested persons more time to submit comments.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 15, 2014.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kellie Taylor, Center for Drug
Evaluation and Research, Food and Drug Administration, Office of
Surveillance and Epidemiology, 10903 New Hampshire Ave., Bldg. 22, Rm.
4418, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 29, 2014 (79 FR 30852), FDA
announced the availability of a draft guidance for industry entitled
``Best Practices in Developing Proprietary Names for Drugs.'' In that
document, FDA requested comments on the draft guidance, which describes
best practices for developing and selecting proposed proprietary names
to minimize medication errors. Interested persons were originally given
until July 28, 2014, to submit comments on the draft guidance to ensure
that the Agency considers their comments before it begins work on the
final version of the guidance.
    The Agency has received several requests to reopen the comment
period for an additional 60 days. The requests conveyed concern that
the original 60-day comment period did not allow sufficient time to
develop a meaningful or thoughtful response.
    FDA has considered the requests and will reopen the comment period
for an additional 30 days. The Agency believes that an additional 30
days allows adequate time for interested persons to submit comments
without significantly delaying the Agency's consideration of these
important issues.

II. How to Submit Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19261 Filed 8-13-14; 8:45 am]
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