[Federal Register: August 7, 2008 (Volume 73, Number 153)]
[Proposed Rules]
[Page 45925-45928]
[DOCID:fr07au08-26]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2008-0472; FRL-8701-9]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Stafford County Reasonably Available Control Technology Under
the 8-Hour Ozone National Ambient Air Quality Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve a State Implementation Plan (SIP)
revision submitted by the Commonwealth of Virginia. This SIP revision
pertains to the requirements in meeting the reasonably available
control technology (RACT) under the 8-hour ozone national ambient air
quality standard (NAAQS). These requirements are based on:
Certification that previously adopted RACT controls in Virginia's SIP
that were approved by EPA under the 1-hour ozone NAAQS are based on the
currently available technically and economically feasible controls, and
that they continue to represent RACT for the 8-hour implementation
purposes; a negative declaration demonstrating that no facilities exist
in Stafford County for the applicable control technology guideline
(CTG) categories; and new RACT determinations. This action is being
taken under the Clean Air Act (CAA).

DATES: Written comments must be received on or before September 8,
2008.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2008-0472 by one of the following methods:
    A. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    B. E-mail<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2008-0472, Cristina Fernandez, Chief, Air
Quality Planning Branch, Mailcode 3AP21, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2008-0472. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or e-mail.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through www.regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the Virginia Department of Environmental Quality, 629
East Main Street, Richmond, Virginia 23219.

FOR FURTHER INFORMATION CONTACT: Gregory Becoat,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On April 21, 2008, the Virginia Department
of Environmental Quality (VADEQ) submitted a revision to its SIP that
addresses Stafford County's requirements of RACT under the 8-hour ozone
NAAQS set forth by the CAA.

I. Background

    Ozone is formed in the atmosphere by photochemical reactions
between volatile organic compounds (VOC), oxides of nitrogen
(NOX) and carbon monoxide (CO) in the presence of sunlight.
In order to reduce ozone concentrations in the ambient air, the CAA
requires all nonattainment areas to apply control on VOC/NOX
emission sources to achieve emission reductions. Among effective
control measures, RACT controls are a major group for reducing VOC and
NOX emissions from stationary sources.
    Since the 1970s, EPA has consistently interpreted RACT to mean the
lowest

emission limit that a particular source is capable of meeting by the
application of the control technology that is reasonably available
considering technological and economic feasibility. See, e.g., 72 FR
20586 at 20610 (April 25, 2007). Section 182 of the CAA sets forth two
separate RACT requirements for ozone nonattainment areas. The first
requirement, contained in section 182(a)(2)(A) of the CAA, and referred
to as RACT fix-up requires the correction of RACT rules for which EPA
identified deficiencies before the CAA was amended in 1990. On March
31, 1994, EPA published a final rulemaking notice approving the
Commonwealth of Virginia's SIP revision in order to correct the
Commonwealth's VOC RACT regulations and establish and require the
implementation for revised SIP regulations to control VOCs (59 FR
15117, March 31, 1994). The second requirement, set forth in section
182(b)(2) of the CAA, applies to moderate (or worse) ozone
nonattainment areas as well as to marginal and attainment areas in
ozone transport region (OTR) established pursuant to section 184 of the
CAA, and requires these areas to implement RACT controls on all major
VOC and NOX emission sources and on all sources and source
categories covered by a control technique guideline (CTG) issued by
EPA. On March 12, 1997, EPA published a final rulemaking notice
approving the Commonwealth of Virginia's SIP revision as meeting the
CTG RACT provisions of the CAA (62 FR 11332, March 12, 1997). Further
details of Virginia's RACT requirements can be found in a Technical
Support Document (TSD) prepared for this rulemaking.
    The counties of Fairfax, Loudoun, Prince William, and Arlington, as
well as the cities of Fairfax, Alexandria, Manassas, Manassas Park, and
Falls Church (Northern Virginia Area), along with Stafford County,
Virginia, Washington, D.C., and portions of southern Maryland, are part
of the OTR. Under the 1-hour ozone NAAQS, these jurisdictions,
including Stafford County, Virginia, Washington, D.C., and portions of
southern Maryland were originally classified as part of the
Metropolitan Washington serious 1-hour ozone nonattainment area located
in OTR (56 FR 56694 at 56844, November 6, 1991). As part of the
planning process, section 182(b)(2) of the CAA required the
Commonwealth of Virginia to implement RACT on all sources and source
categories covered by a CTG issued by EPA. Point sources with the
potential to emit 50 tons per year or more of VOCs or 100 tons per year
or more of NOX that were not covered by a CTG were also
required to implement RACT. As a result of failure to meet the
attainment date of November 15, 1999, the Metropolitan Washington area
was reclassified as a severe nonattainment area for the 1-hour standard
(68 FR 3410 at 3425, January 24, 2003). As a result of the
reclassification, the Commonwealth of Virginia was required to perform
RACT evaluations on point sources with the potential to emit 25 tons
per year for either VOC (62 FR 11334, March 12, 1997) or NOX
(69 FR 48150, August 9, 2004).
    On July 18, 1997, EPA promulgated the new 8-hour NAAQS for ozone
(62 FR 38856, July 18, 1997). Under the 8-hour ozone NAAQS, the
Metropolitan Washington Area, with the exception of Stafford County,
was designated nonattainment for the 8-hour ozone standard and
classified as a moderate nonattainment area. Stafford County was
included as part of the Fredericksburg area, and was designated as a
moderate nonattainment area for the 8-hour ozone NAAQS (69 FR 23858,
April 30, 2004). On May 2, 2005 and May 4, 2005, the Commonwealth of
Virginia submitted a redesignation request and maintenance plan for the
Fredericksburg area, respectively. EPA issued a final rule approving
Virginia's redesignation request and maintenance plan for the
Fredericksburg area on December 23, 2005 (70 FR 76165).
    Although Stafford County is part of the Fredericksburg maintenance
area, the requirements of section 184 of the CAA must still be
satisfied because Stafford County is also part of the OTR. Section
184(b)(1)(B) of the CAA requires the implementation of RACT with
respect to all sources of VOC covered by a CTG. Additionally, section
184(b)(2) of the CAA requires the implementation of major stationary
source requirements as if the area were a moderate nonattainment area
on any stationary source with a potential to emit of at least 50 tons
per year of VOC or 100 tons per year of NOX. Virginia is
therefore required to submit to EPA a SIP revision that demonstrates
how Stafford County meets the RACT requirements under the 8-hour ozone
standard.
    EPA requires under the 8-hour ozone NAAQS that states meet the CAA
RACT requirements, either through a certification that previously
adopted RACT controls in their SIP revisions approved by EPA under the
1-hour ozone NAAQS represent adequate RACT control levels for 8-hour
attainment purposes, or through the adoption of new or more stringent
regulations that represent RACT control levels. A certification must be
accompanied by appropriate supporting information such as consideration
of information received during the public comment period and
consideration of new data. This information may supplement existing
RACT guidance documents that were developed for the 1-hour standard,
such that the State's SIP accurately reflects RACTs for the 8-hour
ozone standard based on the current availability of technically and
economically feasible controls. Adoption of new RACT regulations will
occur when states have new stationary sources not covered by existing
RACT regulations, or when new data or technical information indicates
that a previously adopted RACT measure does not represent a newly
available RACT control level. Another 8-hour ozone NAAQS requirement
for RACT is to submit a negative declaration that there are no CTG
major sources of VOC and NOX emissions within Virginia.

II. Summary of SIP Revision

    Virginia's SIP revision for Stafford County contains the
requirements of RACT set forth by the CAA under the 8-hour ozone NAAQS.
Virginia's SIP revision satisfies the 8-hour RACT requirements through
(1) certification that previously adopted RACT controls in Virginia's
SIP that were approved by EPA under the 1-hour ozone NAAQS are based on
the currently available technically and economically feasible controls,
and that they continue to represent RACT for the 8-hour implementation
purposes; (2) a negative declaration demonstrating that no facilities
exist in Stafford County for the applicable CTG categories; and (3) new
RACT determinations.

VOC RACT Controls

    Virginia's Regulations and Statutes, under 9 VAC 5 Chapter 40,
contain the Commonwealth's VOC RACT controls that were implemented and
approved in the Virginia SIP under the 1-hour ozone NAAQS.
    Table 1 lists Virginia's VOC RACT controls.

                                      Table 1--Virginia's VOC RACT Controls
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                                                          Existing stationary sources
                              ----------------------------------------------------------------------------------
    Regulation 9 VAC 5-40-                                  State       Federal
                                  Title of regulation     effective     Register              Citation
                                                             date         date
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460..........................  Emission Standards for       02/01/02     03/03/06  71 FR 10838.
                                Synthesized
                                Pharmaceutical Products
                                Manufacturing
                                Operations.
610..........................  Emission Standards for       04/17/95     04/21/00  65 FR 21315.
                                Rubber Tire
                                Manufacturing
                                Operations.
1400.........................  Emission Standards for       04/17/95     04/21/00  65 FR 21315.
                                Petroleum Refinery
                                Operations.
3290.........................  Emission Standards for       04/01/97     11/03/99  64 FR 59635.
                                Solvent Metal Cleaning
                                Operations Using Non-
                                Halogenated Solvents.
3590.........................  Emission Standards for       04/17/95     04/21/00  65 FR 21315.
                                Large Appliance Coating
                                Application Systems.
3740.........................  Emission Standards for       04/17/95     04/21/00  65 FR 21315.
                                Magnet Wire Coating
                                Application Systems.
3890.........................  Emission Standards for       04/17/95     04/21/00  65 FR 21315.
                                Automobile and Light
                                Duty Truck Coating
                                Application Systems.
4040.........................  Emission Standards for       04/17/95     04/21/00  65 FR 21315.
                                Can Coating Application
                                Systems.
4190.........................  Emission Standards for       04/17/95     04/21/00  65 FR 21315.
                                Metal Coil Coating
                                Application Systems.
4340.........................  Emission Standards for       04/17/95     04/21/00  65 FR 21315.
                                Paper and Fabric
                                Coating Application
                                Systems.
4490.........................  Emission Standards for       04/17/95     04/21/00  65 FR 21315.
                                Vinyl Coating
                                Application Systems.
4640.........................  Emission Standards for       04/17/95     04/21/00  65 FR 21315.
                                Metal Furniture Coating
                                Application Systems.
4790.........................  Emission Standards for       04/17/95     04/21/00  65 FR 21315.
                                Miscellaneous Metal
                                Parts and Products
                                Coating Application
                                Systems.
4940.........................  Emission Standards for       04/17/95     04/21/00  65 FR 21315.
                                Flatwood Paneling
                                Coating Application
                                Systems.
5080.........................  Flexographic, Packaging      04/01/96     03/12/97  62 FR 11334.
                                Rotogravure, and
                                Publication Rotogravure
                                Printing Lines.
5230.........................  Emission Standards for       02/01/02     03/03/06  71 FR 10838.
                                Petroleum Liquid
                                Storage and Transfer
                                Operations--Stage I
                                Vapor Control Systems--
                                Gasoline Service
                                Stations.
5230.........................  Emission Standards for       02/01/02     03/03/06  71 FR 10838.
                                Petroleum Liquid
                                Storage and Transfer
                                Operations--Tank Truck
                                Gasoline Loading
                                Terminals.
5230.........................  Emission Standards for       02/01/02     03/03/06  71 FR 10838.
                                Petroleum Liquid
                                Storage and Transfer
                                Operations--Bulk
                                Gasoline Plants.
5230.........................  Emission Standards for       02/01/02     03/03/06  71 FR 10838.
                                Petroleum Liquid
                                Storage and Transfer
                                Operations--Petroleum
                                Liquids in Fixed Roof
                                Tanks.
5230.........................  Emission Standards for       02/01/02     03/03/06  71 FR 10838.
                                Petroleum Liquid
                                Storage and Transfer
                                Operations--Petroleum
                                Liquid Storage in
                                External Floating Roof
                                Tanks.
5230.........................  Emission Standards for       02/01/02     03/03/06  71 FR 10838.
                                Petroleum Liquid
                                Storage and Transfer
                                Operations--Gasoline
                                Tank Trucks and Vapor
                                Collection Systems.
5510.........................  Emission Standards for       03/24/04     04/27/05  70 FR 21625.
                                Asphalt Paving
                                Operations.
6840.........................  Emission Standards for       03/24/04     06/09/04  69 FR 32277.
                                Solvent Metal Cleaning
                                Operations in the
                                Northern Virginia
                                Volatile Organic
                                Compound Emissions
                                Control Area.
----------------------------------------------------------------------------------------------------------------

    Virginia also submitted a negative declaration certifying that the
following VOC CTG or non-CTG major sources do not exist in Stafford
County.
    Table 2 lists Virginia's negative declaration for VOC CTG major
sources.

 Table 2--Documents for Which No Applicable Facilities Exist in Stafford
                                 County
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                             Document title
-------------------------------------------------------------------------
Control of Volatile Organic Compound Leaks from Petroleum Refinery
 Equipment
Control of Volatile Organic Compound Emissions form Large Petroleum Dry
 Cleaners
Control of Volatile Organic Compound Emissions from Manufacture of High
 Density Polyethylene, Polypropylene, and Polystyrene Resins
Control of Volatile Organic Compound Equipment Leaks form Natural Gas/
 Gasoline Processing Plants
Control of Volatile Organic Compound fugitive Emission from Synthetic
 Organic Chemical Polymer and Resin Manufacturing Equipment
Control of Volatile Organic Compound Emissions from Air Oxidation
 Processes in Synthetic Organic Chemical Manufacturing Industry
SOCMI Distillation and Reactor Processes CTG
Wood Furniture
Shipbuilding/repair
Aerospace
------------------------------------------------------------------------

NOX RACT Controls

    The only facility in Stafford County considered to be a major
stationary source for either VOC or NOX is Cellofoam.
Because actual VOC emissions from Cellofoam are significantly below the
facility's federally enforceable limit, the Cellofoam source specific
new RACT determination is appropriate, and therefore, the existing RACT
controls can be recertified. Further details can be found in a TSD
prepared for this rulemaking.

III. Proposed Action

    EPA is proposing to approve the Virginia SIP revision for Stafford
County that addresses the requirements of RACT under the 8-hour ozone
NAAQS, which was submitted on April 21, 2008. This SIP revision is
based on a combination of (1) certification that previously adopted
RACT controls in Virginia's SIP that were approved by EPA under the 1-
hour ozone NAAQS are based on the currently available

technically and economically feasible controls, and that they continue
to represent RACT for the 8-hour implementation purposes; (2) a
negative declaration demonstrating that no facilities exist in Stafford
County for the applicable CTG categories; and (3) new RACT
determinations. EPA is soliciting public comments on the issues
discussed in this document. These comments will be considered before
taking final action.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the Clean Air Act. Accordingly,
this action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule, pertaining to the Stafford County,
VA RACT under the 8-hour ozone NAAQS, does not have tribal implications
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Nitrogen dioxide,
Ozone, Reporting and recordkeeping requirements, Volatile organic
compounds.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: July 25, 2008.
Donald S. Welsh,
Regional Administrator, Region III.
[FR Doc. E8-18191 Filed 8-6-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 93 (Friday, May 13, 2011)]
[Rules and Regulations]
[Pages 27863-27865]
[FR Doc No: 2011-11331]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0390; Directorate Identifier 2011-NM-064-AD;
Amendment 39-16696; AD 2011-10-15]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A318-112, A319-111, A319-
112, A319-115, A319-132, A319-133, A320-214, A320-232, A320-233, A321-
211, A321-213, and A321-231 Airplanes

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

ACTION: Final rule; request for comments.

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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:

    Electrical discontinuity has been detected on terminal modules
Part Number (P/N) NSA 937901M1604, manufactured by Deutsch, due to
an insufficient crimping of the female contacts on the shunt, caused
by a wrong setting of the crimping tool.
* * * * *
    This condition, if not corrected, could potentially result in
in-flight failure of the Electrical Flight Control System (EFCS) and
consequent loss of control of the aeroplane. In addition, this
condition could lead to a non detected passenger oxygen loss, which,
in case of emergency, could result in a large number of passenger
oxygen masks not being supplied with oxygen, possibly causing
personal injuries.

This AD requires actions that are intended to address the unsafe
condition described in the MCAI.

DATES: This AD becomes effective May 31, 2011.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of May 31, 2011.
    We must receive comments on this AD by June 27, 2011.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

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 this AD, 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.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone 425-
227-1405; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2011-0054, dated March 24, 2011 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    Electrical discontinuity has been detected on terminal modules
Part Number (P/N) NSA 937901M1604, manufactured by Deutsch, due to
an insufficient crimping of the female contacts on the shunt, caused
by a wrong setting of the crimping tool.
    The investigations revealed that this manufacturing quality
deficiency is related only to modules P/N NSA 937901M1604 with
manufacturing date codes 08-14 and 08-18.
    This condition, if not corrected, could potentially result in
in-flight failure of the Electrical Flight Control System (EFCS) and
consequent loss of control of the aeroplane. In addition, this
condition could lead to a non detected passenger oxygen loss, which,
in case of emergency, could result in a large number of passenger
oxygen masks not being supplied with oxygen, possibly causing
personal injuries.
    For the reasons described above, this [EASA] AD requires the
identification and replacement of the affected terminal modules.
This [EASA] AD also prohibits the installation of the affected
modules on any aeroplane as replacement parts.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Airbus has issued Service Bulletin A320-92A1072, including Appendix
01, dated March 13, 2009. The actions described in this service
information are intended to correct the unsafe condition identified in
the MCAI.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are issuing this AD because we
evaluated all pertinent information and determined the unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between the 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 FAA policies. Any such differences are
highlighted in a NOTE within the AD.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because a
discrepant terminal module could potentially result in an in-flight
failure of the EFCS, resulting in loss of control of the airplane. In
addition, a discrepant terminal module could lead to latent failure of
the passenger oxygen supply, and consequent loss of oxygen supply to
the masks in the event of an emergency. Therefore, we determined that
notice and opportunity for public comment before issuing this AD are
impracticable and that good cause exists for making this amendment
effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2011-0390; Directorate
Identifier 2011-NM-064-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this 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.

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.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator,

the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2011-10-15 Airbus: Amendment 39-16696. Docket No. FAA-2011-0390;
Directorate Identifier 2011-NM-064-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective May 31,
2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Airbus Model A318-112, A319-111, A319-
112, A319-115, A319-132, A319-133, A320-214, A320-232, A320-233,
A321-211, A321-213, and A321-231 airplanes, certificated in any
category, manufacturer serial numbers (MSN) 3603, 3605, 3607, 3610,
3613, 3615 to 3619 inclusive, 3622 to 3627 inclusive, 3629, 3631 to
3634 inclusive, 3636, 3639, 3645, 3647, 3653, 3655, 3657, 3660,
3661, 3663, 3671, 3675, 3687, 3689, 3691, 3694, 3696, 3700, 3702,
3704 and 3705.

Subject

    (d) Air Transport Association (ATA) of America Code 92: Electric
and Electronic Common Installation.

Reason

    (e) The mandatory continued airworthiness information (MCAI)
states:
    Electrical discontinuity has been detected on terminal modules
Part Number (P/N) NSA 937901M1604, manufactured by Deutsch, due to
an insufficient crimping of the female contacts on the shunt, caused
by a wrong setting of the crimping tool.
* * * * *
    This condition, if not corrected, could potentially result in
in-flight failure of the Electrical Flight Control System (EFCS) and
consequent loss of control of the aeroplane. In addition, this
condition could lead to a non detected passenger oxygen loss, which,
in case of emergency, could result in a large number of passenger
oxygen masks not being supplied with oxygen, possibly causing
personal injuries.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Actions

    (g) Within 600 flight hours after the effective date of this AD,
identify the manufacturing date code of each Deutsch module part
number (P/N) NSA 937901M1604 installed on the airplane, which can be
installed on electronics rack 103VU, pylon harnesses, S15/19
harnesses and/or electronics rack 80VU, as applicable. If any module
with manufacturing date code 08-14 is installed on the electronics
rack 103VU, pylon harnesses, or S15/19 harnesses; or if any module
with manufacturing date code 08-14 or 08-18 is installed on the
electronics rack 80VU; as applicable: Before further flight, replace
each affected module with a serviceable part having the same part
number but a different date code, in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A320-92A1072,
dated March 13, 2009.

Parts Installation

    (h) As of the effective date of this AD, no person may install,
on any airplane, a Deutsch module P/N NSA 937901M1604 with a
manufacturing date code of 08-14 or 08-18.

FAA AD Differences

    Note:  This AD differs from the MCAI and/or service information
as follows: The MCAI prohibits installation of the part identified
in paragraph (h) of this AD after accomplishing the actions
specified in paragraph (g) of this AD, but this AD prohibits
installation of the part as of the effective date of this AD.

Other FAA AD Provisions

    (i) 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. 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 International Branch, send it to ATTN: Sanjay
Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington
98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information
may be e-mailed to<EMAIL_ADDRESS>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. The
AMOC approval letter must specifically refer to this AD.
    (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.

Related Information

    (j) Refer to MCAI EASA Airworthiness Directive 2011-0054, dated
March 24, 2011; and Airbus Service Bulletin A320-92A1072, dated
March 13, 2009; for related information.

Material Incorporated by Reference

    (k) You must use Airbus Service Bulletin A320-92A1072, excluding
Appendix 01, dated March 13, 2009, 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
Airbus, Airworthiness Office--EAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; e-mail<EMAIL_ADDRESS>Internet
http://www.airbus.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the 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/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on April 28, 2011.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-11331 Filed 5-12-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 120 (Monday, June 23, 2014)]
[Notices]
[Pages 35625-35626]
[FR Doc No: 2014-14535]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72408; File No. SR-MIAX-2014-28]

Self-Regulatory Organizations: Notice of Filing of a Proposed
Rule Change by Miami International Securities Exchange LLC To Amend
Rule 515

June 17, 2014.
    Pursuant to the provisions of Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on June 5, 2014, Miami International Securities
Exchange LLC (``MIAX'' or ``Exchange'') filed with the Securities and
Exchange Commission (``Commission'') a proposed rule change as
described in Items I, II, and III below, which Items have been prepared
by the Exchange. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to amend Exchange Rule 515.
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.miaxoptions.com/filter/wotitle/rule_filing, at
MIAX's principal office, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Rule 515(c)(2) in order to provide
that the liquidity refresh pause will be terminated early and normal
trading will resume if during a liquidity refresh pause, the ABBO on
the same side of the market as the initiating order crosses the
original NBBO price on the opposite side of the market. The proposed
change is designed to codify existing functionality during the
liquidity refresh pause. The proposed change will allow the liquidity
refresh pause to terminate and normal trading resume without delay,
thus freeing up the initiating order and any same side joiners received
during the timer, when the market has changed in a manner that renders
the initiating order and same side joiners no longer marketable. Once
normal trading resumes, the initiating order and any same side joiners
held within the liquidity refresh pause would be free to compete for
executions with the new revised same side ABBO at additional price
points which may lead to additional execution opportunities.
    The following examples describe how a new revised same side ABBO
that crosses the original NBBO on the opposite side of the market will
terminate the Liquidity Refresh Pause early.

 Example 1--Same Side ABBO Terminates the Liquidity Refresh Pause Early
------------------------------------------------------------------------
         Market                    Bid                      Ask
------------------------------------------------------------------------
             ABBO                1.00 (10)               1.14 (10)
             PLMM                1.00 (10)               1.10 (10)
            LMM 1                1.00 (10)               1.12 (10)
            LMM 2                1.00 (10)               1.15 (10)
            RMM 1                1.00 (10)               1.16 (10)
------------------------------------------------------------------------

     Order 1: Buy limit of 1.13 for 20 contacts with a price
protection instruction of 3 MPVs
     NBBO at time of arrival = 1.00 (50) x 1.10 (10)
     Order 1 is price protected at 1.13 (which is 1.10 + 3 MPV
= 1.13)
    [cir] Order 1 trades 10 contracts with PLMM @1.10
    [cir] Liquidity Refresh Pause is triggered because the MBO of 1.10
was alone at NBBO and PLMM's 1.10 offer was exhausted
    [ssquf] MBBO 1.10 (10) x 1.12 (10)
    [ssquf] Liquidity Refresh message is broadcasted on the Exchange's
data feeds: Buy 10 contracts, exhausted MBO of 1.10
    [cir] ABB updates to 1.12 for 10 contracts; ABBO = 1.12 (10) x 1.14
(10)
    [cir] Liquidity Refresh Pause is terminated early due to the ABB
improving the original NBO of 1.10.
    [cir] Order 1 trades 10 contracts with LMM1 @1.12. Order 1 has been
fully executed.
    [cir] New MBBO: 1.00 (40) x 1.15 (10). New NBBO: 1.12(10) x
1.15(10)

 Example 2--Same Side ABBO Terminates the Liquidity Refresh Pause Early
------------------------------------------------------------------------
         Market                    Bid                      Ask
------------------------------------------------------------------------
             ABBO                1.00 (10)               1.14 (10)
             PLMM                1.00 (10)               1.10 (10)
            LMM 1                1.00 (10)               1.12 (20)
            LMM 2                1.00 (10)               1.15 (10)
            RMM 1                1.00 (10)               1.16 (10)
------------------------------------------------------------------------

     Order 1: Buy limit of 1.13 for 20 contacts with a price
protection instruction of 3 MPVs
     NBBO at time of arrival = 1.00 (50) x 1.10 (10)
     Order 1 is price protected at 1.13 (which is 1.10 + 3 MPV
= 1.13)
    [cir] Order 1 trades 10 contracts with PLMM @1.10
    [cir] Liquidity Refresh Pause is triggered because the MBO of 1.10
was alone at NBBO and PLMM's 1.10 offer was exhausted
    [ssquf] MBBO 1.10 (10) x 1.12 (20)
    [ssquf] Liquidity Refresh message is broadcasted on the Exchange's
data feeds: Buy 10 contracts, exhausted MBO of 1.10 \3\
---------------------------------------------------------------------------

    \3\ Note that the pricing information contained in the Liquidity
Refresh message (Buy 10 contracts, exhausted MBO of 1.10)
corresponds to the MBB (1.10 (10)).
---------------------------------------------------------------------------

    [cir] ABB updates to 1.12 for 10 contracts; ABBO = 1.12 (10) x 1.14
(10)
    [cir] Liquidity Refresh Pause is terminated early due to the ABB
improving the original NBO of 1.10.
    [cir] Order 1 trades 10 contracts with LMM1 @1.12. Order 1 has been
fully executed.
    [cir] LMM1's remaining 10 contracts would be managed and reposted
as firm at 1.13. New MBBO: 1.00 (40) x 1.13 (10). New NBBO: 1.12(10) x
1.13(10)
    As mentioned above, the proposed change is designed to codify
existing functionality that terminates the liquidity refresh pause
early if during a liquidity refresh pause, the ABBO on

the same side of the market as the initiating order crosses the
original NBBO price on the opposite side of the market. The Exchange
believes that this change will help facilitate transactions, remove
impediments to and perfect the mechanism of a free and open market by
freeing up interest in the liquidity refresh pause when conditions have
changed that renders the initiating order and same side joiners no
longer marketable to the benefit of market participants. The proposed
change will also help eliminate potential confusion on behalf of market
participants by clearly stating the System's functionality in this
situation.
2. Statutory Basis
    MIAX believes that its proposed rule change is consistent with
Section 6(b) of the Act \4\ in general, and furthers the objectives of
Section 6(b)(5) of the Act \5\ in particular, in that it is designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to foster cooperation and
coordination with persons engaged in facilitating transactions in
securities, to remove impediments to and perfect the mechanisms of a
free and open market and a national market system and, in general, to
protect investors and the public interest.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The proposal to end the liquidity refresh pause due to the ABBO on
the same side of the market as the initiating order crosses the
original NBBO price on the opposite side of the market is designed to
facilitate transactions, to remove impediments to and perfect the
mechanism of a free and open market by freeing up interest in the
liquidity refresh pause when conditions have changed that renders the
initiating order and same side joiners no longer marketable to the
benefit of market participants. The proposal also promotes the
protection of investors and the public interest by codifying existing
functionality in a manner that should reduce confusion for Exchange
members regarding the termination of a liquidity refresh pause.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. Specifically, the Exchange
believes the proposed changes will not impose any burden on intra-
market competition because it applies to all MIAX participants equally.
In addition, the Exchange does not believe the proposal will impose any
burden on inter-market competition as the proposal is intended to
protect investors by providing further transparency regarding the
Exchange's price protection functionality.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission shall: (a) By order approve
or disapprove such proposed rule change, or (b) institute proceedings
to determine whether the proposed rule change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-MIAX-2014-28 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-MIAX-2014-28. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-MIAX-2014-28 and should be
submitted on or before July 14, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-14535 Filed 6-20-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)]
[Notices]
[Pages 22085-22087]
[FR Doc No: 2018-10051]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0407]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Pilot Project Program
Under the Drug Supply Chain Security Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 (PRA).

DATES: Fax written comments on the collection of information by June
11, 2018.

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 protected]. All
comments should be identified with the OMB control number 0910-NEW and
title ``Pilot Project Program Under the Drug Supply Chain Security
Act.'' Also include the FDA docket number found in brackets in the
heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

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:

The DSCSA Pilot Project Program

OMB Control Number 0910--NEW

    FDA will be establishing the Drug Supply Chain Security Act (DSCSA)
(Title II of Pub. L. 113-54) Pilot Project Program to implement section
582(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360eee-1). This program will assist FDA in developing an
interoperable, electronic system to identify and trace certain
prescription drugs as the drugs are distributed in the United States by
the year 2023. The Pilot Project Program goals include assessing the
ability of supply chain members to: (1) Satisfy the requirements of
section 582 of the FD&C Act; (2) identify, manage, and prevent the
distribution of suspect and illegitimate products as defined in section
581(21) and (8) of the FD&C Act (21 U.S.C. 360eee(21) and (8)),
respectively; and (3) demonstrate the electronic, interoperable
exchange of product tracing information across the pharmaceutical
distribution supply chain, in addition to identifying the system
attributes needed to implement the requirements of section 582 of the
FD&C Act, particularly the requirement to utilize a product identifier
for product tracing purposes. FDA plans to coordinate with stakeholders
that reflect the diversity of the pharmaceutical distribution supply
chain, including large and small entities from all industry sectors.
    Title: The DSCSA Pilot Project Program.
    Description of Respondents: Respondents of this collection of
information are participants from the pharmaceutical distribution
supply chain (authorized manufacturers, repackagers, wholesale
distributors, and dispensers) and other stakeholders.
    Background Information: FDA will be seeking pilot project
participants from the pharmaceutical distribution supply chain
(authorized manufacturers, repackagers, wholesale distributors, and
dispensers) and other stakeholders. FDA expects that participants will
propose the design and execution of their pilot project in their
submission to FDA; however, FDA also intends to meet with all pilot
project participants to ensure that lessons learned from the pilot
project(s) will inform FDA's development of the electronic,
interoperable system that will take effect in 2023. FDA encourages
supply chain members to focus their proposed pilot project(s) on the
DSCSA requirements related to the interoperable, electronic tracing of
products at the package level. Specifically, the pilot project(s)
should focus on the requirements for package-level tracing and
verification that take effect in 2023. Such pilot projects will be more
useful than pilot projects dedicated to lot-level tracing. If there are
adequate pilot project submissions, FDA may establish more than one
pilot project to accomplish the goals of the DSCSA Pilot Project
Program.
    Because there is an information collection under the PRA associated
with the DSCSA Pilot Project Program, this Federal Register notice is
being issued as part of the process for OMB approval to collect this
information. After OMB approval of this information collection, FDA
will accept applications to participate in the program and will select
qualified applications. FDA will announce OMB's approval in the Federal
Register, the date that applications may be submitted, and application
submission procedures.
    In the Federal Register of July 20, 2017 (82 FR 33497), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. A summary of the comments and FDA's
responses are as follows.
    (Comment 1) Several comments raised concerns with the proposed
timelines related to initiation of pilot projects, duration of pilot
projects, and final reports. One comment expressed concern that 4
months (after receiving a letter of acceptance from FDA) may not be
enough time for a potential participant to be ready to initiate their
pilot project. Another comment suggested that the proposed duration of
pilot projects (no more than 6 months) should be longer and FDA should
give the participant(s) more flexibility to conduct the pilot project.
In addition, another comment expressed concern with the proposed
requirement that final reports be completed within 30 days, because
that may not be enough time to complete a final report.
    (Response 1) The proposed timelines were intended to enable
completion of FDA's Pilot Project Program within 1 year of the start
date. FDA would like to complete the program in a timely manner so that
the information learned can be shared and utilized by supply chain
participants as they prepare and implement remaining DSCSA requirements
that take effect between 2018 and 2023. To optimize the program, FDA
expects pilot project participants to be ready to initiate their pilot
project within 4 months after receiving a letter of acceptance from
FDA. This will help ensure that participants have worked out funding,
resources, planning, and other issues in advance of initiation of the
pilot project. FDA provided flexibility in the program

by allowing the Agency to consider pilot projects that may go beyond a
6-month period; however, a pilot project duration of 6 months or less
is preferred.
    (Comment 2) Another comment requested clarification of the proposed
process for selecting participants. The comment expressed concern that
FDA's Pilot Project Program may include only those entities that are
most engaged in DSCSA implementation currently. The comment also
described concern that the findings and results may not accurately
reflect the current environment, because the program may not include
supply chain members with fewer resources, less sophisticated
compliance methods, or that are not as closely connected as other
trading partners.
    (Response 2) Participation in the Pilot Project Program is open to
anyone in the pharmaceutical distribution supply chain (authorized
manufacturers, repackagers, wholesale distributors, and dispensers) and
other stakeholders. FDA plans to coordinate with stakeholders that
reflect the diversity of the pharmaceutical distribution supply chain,
including large and small entities from all industry sectors. FDA
expects that participants will propose the design and execution of
their pilot project in their submission to FDA, which may include
coordination with partnering entities. Such coordination may help
resolve some of the concern that the findings and results may not
accurately reflect the current environment of supply chain members that
may have fewer resources or less sophisticated compliance methods.
    (Comment 3) Another comment did not support FDA considering
products for eligibility in proposed pilot projects that may be outside
the scope of the DSCSA definition of ``product,'' such as over-the-
counter medications. The comment suggested that if FDA is expanding the
scope of pilot projects to include additional products, then the
timeline for pilot projects would need to be delayed beyond 2023 to
allow sufficient time for supply chain participants to adjust to the
needs of these expanded pilots.
    (Response 3) Allowing FDA to consider products eligible for the
Pilot Project Program that may be outside the DSCSA definition of
``product'' was intended to provide flexibility to potential
participants that may choose to test a process or system involving
broader categories of products. Including products that are outside the
DSCSA definition in pilot projects is not a requirement; however, we
believe there may be an opportunity to learn from such pilot projects.
This consideration does not justify a need to delay the timeline for
the pilot projects beyond 2023. It will be up to participants to
propose the design and execution of their pilot project in their
submission to FDA. FDA will consider multiple factors to ensure that
the pilot project(s) selected for the program will support the program
goals.
    (Comment 4) Another comment believed that having pilot participants
fund their pilot projects would conflict with the need to include a
diverse set of supply chain stakeholders because some supply chain
stakeholders do not have the resources to participate in a pilot
project.
    (Response 4) There is no FDA funding for the Pilot Project Program
provided in the DSCSA, and participation is on a volunteer basis. FDA
plans to coordinate with stakeholders that reflect the diversity of the
pharmaceutical distribution supply chain, including large and small
entities from all industry sectors. FDA expects participants to be
responsible for funding and providing resources to support the pilot
projects. Participants will develop and propose the design and
execution of their pilot project in their submission to FDA, which may
include coordination with partnering entities in a manner that may
resolve resource concerns.
    Reporting Burden Estimates: FDA estimates that no more than 10
respondents will submit a request to participate, and that it will take
approximately 80 hours to complete a request and submit the request to
FDA. FDA estimates that it will select no more than eight respondents
for the pilot program. The estimated total time for respondents to
submit a request to participate in the program is 800 hours. Once the
request to participate is accepted, the submitter is now a participant
of the DSCSA Pilot Project Program. FDA estimates that the eight
respondents (i.e., participants) will submit an average of five
progress reports to FDA. Because the duration of a pilot project should
not exceed 6 months, the frequency of the progress reports will vary
based on the length of the individual pilot project. Pilot projects of
relatively shorter duration may result in shorter time intervals
between progress reports so that the reports will be sufficient to
capture progress while the pilot project is ongoing. FDA estimates that
it will take approximately 8 hours to compile and submit each progress
report. The estimated total number of hours for submitting progress
reports would be 320 hours. After completion of their pilot project,
each participant will provide one final report to FDA. FDA estimates
that it will take the eight participants approximately 40 hours to
submit a final report. The estimated total number of hours for
submitting the final report is 320 hours. The total hours for the
estimated reporting burden are 1,440 hours (table 1).
    Recordkeeping Burden Estimates: Recordkeeping activities include
storing and maintaining records related to submitting a request to
participate in the program and compiling reports. Respondents can use
current record retention capabilities for electronic or paper storage
to achieve these activities. FDA estimates that no more than 10
respondents will have recordkeeping activities related to program
participation. FDA believes that it will take 0.5 hour/year to ensure
that the documents related to submitting a request to participate in
the program are retained properly for a minimum of 1 year after the
pilot project is completed (as recommended by FDA). The resulting total
to maintain the records related to submitting a request is 5 hours
annually. For retaining records related to progress reports and the
final report properly for a minimum of 1 year after the pilot project
is completed (as recommended by FDA), FDA estimates that it will take
approximately 0.5 hour/year. As noted previously, FDA estimates that
the eight respondents will submit an average of five progress reports
and one final report to FDA. The estimated total for maintaining
progress reports and the final report is 20 and 4 hours, respectively.
The total recordkeeping burden is estimated to be 29 hours (table 2).
    In developing its burden estimate for records associated with the
proposed pilot projects, FDA has taken account of existing industry
practices for maintaining records in the normal course of their
business. In particular, FDA is aware of various supply chain
stakeholders that have conducted pilot projects over the past few
years, including some pilot projects that occurred before the DSCSA was
enacted. These pilot projects covered topics related to serialization,
movement of product data, aggregation of data, and verification of
product identifiers of returned products. Members of the supply chain
who conduct pilot projects of their own accord created associated
records as a matter of usual and customary business practice.
Therefore, FDA considers these activities associated with a pilot
project to be usual and customary business practice, and the burden
estimates for like records are not included in the

calculation of the recordkeeping burden (see 5 CFR 1320.3(b)(2)).
    Third-Party Disclosure Burden Estimates: For those pilot projects
that involve a participant composed of partnering entities in the
program, FDA is taking into consideration the time that partnering
entities will spend coordinating with each other during a pilot
project. For the initial request to participate, FDA estimates that
eight respondents will work with their respective partnering entities,
and the average number of partnering entities will be two. FDA
estimates that each respondent will spend 8 hours coordinating with
each partnering entity. Thus, for 8 respondents with an average of 2
partnering entities, the estimated total burden for coordinating with
partnering entities related to the submission of the request to
participate in the program is 128 hours. FDA estimates that seven
respondents will need to coordinate with an average of two partnering
entities to create progress reports and the final report to submit to
FDA. Earlier, FDA estimated that an average of five progress reports
will be submitted to FDA per respondent. If a respondent has an average
of 2 partners, it will coordinate 10 times with those partners on the
progress reports. FDA estimates that for each progress report, it will
take 4 hours to coordinate with each partner, resulting in a total of
280 hours. FDA estimates that for each final report, it will take
approximately 20 hours to coordinate with each partner, resulting in a
total of 280 hours. The total estimation for third-party disclosure
burden is 688 hours (table 3).
    FDA estimates the burden of this collection of information as
follows:

                                                         Table 1--Estimated Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                    DSCSA pilot project program                        Number of      responses per    Total annual     Average  burden     Total hours
                                                                      respondents      respondent        responses       per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requests to participate...........................................              10                 1              10                  80             800
Progress reports..................................................               8                 5              40                   8             320
Final report to FDA...............................................               8                 1               8                  40             320
                                                                   -------------------------------------------------------------------------------------
    Total.........................................................  ..............  ................  ..............  ..................           1,440
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
         DSCSA pilot project program             Number of       records per     Total annual      Average  burden per  recordkeeping       Total hours
                                               recordkeepers    recordkeeper        records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Records related to requests to participate..              10                 1              10  0.5 (30 minutes)........................               5
Records related to progress reports.........               8                 5              40  0.5 (30 minutes)........................              20
Records related to the final report to FDA..               8                 1               8  0.5 (30 minutes)........................               4
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ................  ..............  ........................................              29
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                    DSCSA pilot project program                        Number of     disclosures per   Total annual     Average  burden     Total hours
                                                                      respondents      respondent       disclosures     per  disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Coordination with partnering entities related to requests to                     8                 2              16                   8             128
 participate......................................................
Coordination with partnering entities related to progress reports.               7                10              70                   4             280
Coordination with partnering entities related to final reports....               7                 2              14                  20             280
                                                                   -------------------------------------------------------------------------------------
    Total.........................................................  ..............  ................  ..............  ..................             688
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: May 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10051 Filed 5-10-18; 8:45 am]
 BILLING CODE 4164-01-P