[Federal Register Volume 76, Number 66 (Wednesday, April 6, 2011)]
[Notices]
[Pages 19179-19182]
[FR Doc No: 2011-8082]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2011-0030]

Spyker Automobielen B.V.; Receipt of Application for Extension of
Temporary Exemption From Certain Requirements of FMVSS No. 208

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice of receipt of petition for extension of a temporary
exemption from certain provisions of Federal Motor Vehicle Safety
Standard (FMVSS) No. 208, Occupant Crash Protection.

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SUMMARY: In accordance with the procedures in 49 CFR Part 555, Spyker
Automobielen B.V. (Spyker) has applied for an extension of a previously
granted temporary exemption from certain advanced air bag requirements
of FMVSS No. 208, Occupant Crash Protection, for its C line of
vehicles. The basis of the application is that compliance would cause
substantial economic hardship to a manufacturer that has tried in good
faith to comply with the standard.
    NHTSA is publishing this notice of receipt of the application in
accordance with the requirements of 49 U.S.C. 30113(b)(2), and has made
no judgment on the merits of the application.

DATES: You should submit your comments not later than May 6, 2011.

FOR FURTHER INFORMATION CONTACT: William H. Shakely, Office of the
Chief Counsel, NCC-112, National Highway Traffic Safety Administration,
1200 New Jersey Avenue, SE., West Building 4th Floor, Room W41-212,
Washington, DC 20590. Telephone:<PHONE_NUMBER>; Fax:<PHONE_NUMBER>.
    Comments: We invite you to submit comments on the application
described above. You may submit comments identified by the docket
number at the heading of this notice by any of the following methods:
     Web Site: http://www.regulations.gov. Follow the
instructions for submitting comments on the electronic docket site by
clicking on ``Help and Information'' or ``Help/Info.''
     Fax: 1-202-493-2251.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., West Building
Ground Floor, Room W12-140, Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
    Instructions: All submissions must include the agency name and
docket number. Note that all comments received will be posted without
change to http://www.regulations.gov, including any personal
information provided. Please see the Privacy Act discussion below. We
will consider all comments received before the close of business on the
comment closing date indicated above. To the extent possible, we will
also consider comments filed after the closing date.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov at any time or to
1200 New Jersey Avenue, SE., West Building Ground Floor, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. Telephone:<PHONE_NUMBER>.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit
http://www.dot.gov/privacy.html.
    Confidential Business Information: If you wish to submit any
information under a claim of confidentiality, you should submit three
copies of your complete submission, including the information you claim
to be confidential business information, to the Chief Counsel, NHTSA,
at the address given under FOR FURTHER INFORMATION CONTACT. In
addition, you should submit two copies, from which you have deleted the
claimed confidential business information, to Docket Management at the
address given above. When you send a comment containing information
claimed to be confidential business information, you should include a
cover letter setting forth the information specified in our
confidential business information regulation (49 CFR part 512).

SUPPLEMENTARY INFORMATION:

I. Overview of Petition for Economic Hardship Exemption

    In accordance with 49 U.S.C. 30113 and the procedures in 49 CFR
part 555, Spyker has submitted a petition (dated October 13, 2010)
asking the agency for

an extension of a temporary exemption from certain advanced air bag
requirements of FMVSS No. 208 for its C line of vehicles. The existing
exemption was set to expire on December 15, 2010. The basis for the
application is that compliance would cause substantial economic
hardship to a manufacturer that has tried in good faith to comply with
the standard. After filing its petition, Spyker submitted additional
information regarding its compliance efforts.
    The agency closely examines and considers the information provided
by manufacturers in support of these factors, and, in addition,
pursuant to 49 U.S.C. 30113(b)(3)(A), determines whether an exemption
is in the public interest and consistent with the Safety Act.\1\ Spyker
requested an extension until May 15, 2012. Copies of Spyker's petition
and its supplemental statement \2\ are available for review and have
been placed in the docket for this notice.
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    \1\ The Safety Act is codified as Title 49, United States Code,
Chapter 301.
    \2\ Spyker has requested confidential treatment under 49 CFR
Part 512 for certain business and financial information submitted as
part of its petition for temporary exemption. Accordingly, the
information placed in the docket does not contain the information
that is the subject of this request.
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    A manufacturer is eligible to apply for a hardship exemption if its
total motor vehicle production in its most recent year of production
did not exceed 10,000 vehicles, as determined by the NHTSA
Administrator (49 U.S.C. 30113).
    Additionally, although 49 U.S.C. 30113(b) states that exemptions
from a Safety Act standard are to be granted on a ``temporary basis,''
\3\ the statute also expressly provides for renewal of an exemption on
reapplication. Manufacturers are nevertheless cautioned that the
agency's decision to grant an initial petition in no way predetermines
that the agency will repeatedly grant renewal petitions, thereby
imparting semi-permanent exemption from a safety standard. Exempted
manufacturers seeking renewal must bear in mind that the agency is
directed to consider financial hardship as but one factor, along with
the manufacturer's on-going good faith efforts to comply with the
regulation, the public interest, and consistency with the Safety Act
generally, as well as other such matters provided in the statute.
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    \3\ 49 U.S.C. 30113(b)(1).
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    We note that under 49 CFR 555.8(e), ``If an application for renewal
of a temporary exemption that meets the requirements of Sec.  555.5 has
been filed not later than 60 days before the termination date of an
exemption, the exemption does not terminate until the Administrator
grants or denies the application for renewal.'' In this case, Spyker
submitted its petition for extension by the deadline stated in 49 CFR
555.8(e).

II. Advanced Air Bag Requirements and Small Volume Manufacturers

    The agency published the final rule requiring advanced air bags in
May 2000. The rule was intended to improve protection for occupants of
different sizes, belted and unbelted, under FMVSS No. 208, while
minimizing the risk to infants, children, and other occupants from
injuries and deaths caused by air bags. The rule accomplished this by
establishing new test requirements and injury criteria and specifying
the use of an entire family of test dummies: The then-existing dummy
representing 50th percentile adult males, and new dummies representing
5th percentile adult females, 6-year-old children, 3-year-old children,
and 1-year-old infants.
    The advanced air bag requirements were a culmination of a
comprehensive plan that the agency announced in 1996 to address the
adverse effects of air bags. This plan also included an extensive
consumer education program to encourage the placement of children in
rear seats. The new requirements were phased in beginning with the 2004
model year. The requirements did not apply to small manufacturers until
September 1, 2006.
    In recent years, NHTSA has addressed a number of petitions for
exemption from the advanced air bag requirements of FMVSS No. 208. The
majority of these requests have come from small manufacturers that have
petitioned on the basis of substantial economic hardship to a
manufacturer that has tried in good faith to comply with the standard.
    Although NHTSA has granted a number of these petitions in
situations where the manufacturer is supplying standard air bags in
lieu of advanced air bags,\4\ NHTSA is considering (1) whether it is in
the public interest to continue to grant such petitions, particularly
in the same manner as in the past, given the number of years these
requirements have now been in effect and the benefits of advanced air
bags, and (2) to the extent such petitions are granted, what plans and
countermeasures to protect child and infant occupants, short of
compliance with the advanced air bags, should be expected.
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    \4\ See, e.g., grant of petition to Panoz, 72 FR 28759 (May 22,
2007); grant of petition to Koenigsegg, 72 FR 17608 (April 9, 2007).
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    Given the passage of time since the advanced air bag requirements
were established and have been implemented, and in light of the
benefits of advanced air bags, NHTSA is concerned that it may not be in
the public interest to continue to grant exemptions from these
requirements, particularly in the same manner as in the past. The costs
of compliance with the advanced air bag requirements of FMVSS No. 208
are costs that all entrants to the U.S. automobile marketplace should
expect to bear. Furthermore, NHTSA understands that, in contrast to the
initial years after the advanced air bag requirements went into effect,
low volume manufacturers now have access to advanced air bag
technology. Accordingly, NHTSA tentatively concludes that the expense
of advanced air bag technology may not now be sufficient, in and of
itself, to justify the grant of a petition for a hardship exemption
from the advanced air bag requirements.
    NHTSA further notes that exemptions from motor vehicle safety
standards are to be granted on a ``temporary basis.'' \5\ In prior
petitions, NHTSA has granted temporary exemptions from the advanced air
bag requirements as a means of affording eligible manufacturers a
transition period to comply with the exempted standard. Accordingly, in
deciding whether to grant an exemption based on substantial economic
hardship, NHTSA ordinarily considers the steps that the manufacturer
has already taken to achieve compliance, as well as the future steps
the manufacturer plans to take during the exemption period and the
estimated date by which full compliance will be achieved.\6\
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    \5\ 49 U.S.C. 30113(b)(1).
    \6\ 49 CFR 555.6(a)(2).
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    NHTSA invites comment on whether and in what circumstances (e.g.,
nature of vehicles, number of vehicles, level of efforts to comply with
the requirements, timing as to number of years since the requirements
were implemented, etc.) it should continue to grant petitions for
exemptions from the advanced air bag requirements of FMVSS No. 208. We
note that any policy statements we may make in this area would not have
the effect of precluding manufacturers from submitting subsequent
petitions for exemption. However, we believe it could be helpful for
manufacturers to know our general views in advance of submitting a
petition.

III. Spyker's Petition

    Background--Spyker, a Netherlands corporation, was founded in 2000
and has been producing a small number of luxury sports cars since
February 2002. On July 6, 2005, NHTSA granted Spyker a three-year
hardship exemption from several FMVSSs, including the ``basic'' air bag
requirements and advanced air bag provisions of FMVSS No. 208
(S<IP_ADDRESS>; S14), as well as 49 CFR part 581, Bumper Standard (70 FR
39007 (July 6, 2005)). This exemption was set to expire on June 15,
2008. In this same grant, NHTSA also exempted the first ten Spyker C8
vehicles imported into the United States from S7 of FMVSS No. 108,
Lamps, reflective devices, and associated equipment.
    On March 25, 2009, NHTSA granted Spyker a 30-month limited
extension from the child and 5th percentile adult female driver out-of-
position portions of the advanced air bag provisions of FMVSS No. 208
(S19, S21, S23, and S25) (74 FR 12925 (Mar. 25, 2009)). This extension
was set to expire on December 15, 2010, but has been extended
automatically by the filing of Spyker's application for an extension.
    Requested Exemption--Spyker has applied for a further extension of
its temporary exemption. Specifically, Spyker requests that the
exemption from the child and 5th percentile adult female driver out-of-
position portions of the advanced air bag provisions of FMVSS No. 208
(S19, S21, S23, and S25) be extended until May 15, 2012.
    Eligibility--A manufacturer is eligible to apply for a hardship
exemption if its total motor vehicle production in its most recent year
of production did not exceed 10,000 vehicles, as determined by the
NHTSA Administrator (49 U.S.C. 30113(d)). In determining whether a
manufacturer of a vehicle meets that criterion, NHTSA considers whether
a second vehicle manufacturer also might be deemed the manufacturer of
that vehicle. The statutory provisions governing motor vehicle safety
(49 U.S.C. Chapter 301) do not state that a manufacturer has
substantial responsibility as manufacturer of a vehicle simply because
it owns or controls a second manufacturer that assembled that vehicle.
However, the agency considers the statutory definition of
``manufacturer'' (49 U.S.C. 30102) to be sufficiently broad to include
sponsors, depending on the circumstances. Thus, NHTSA has stated that a
manufacturer may be deemed to be a sponsor and thus a manufacturer of a
vehicle assembled by a second manufacturer if the first manufacturer
had a substantial role in the development and manufacturing process of
that vehicle.
    Spyker Automobielen B.V. is a small volume manufacturer of luxury
sports cars. Since 2005, Spyker Automobielen B.V. has manufactured less
than 100 vehicles annually worldwide, and the company projects that it
will manufacture 103 vehicles in 2011. However, the petition stated
that Spyker Automobielen B.V. is a wholly owned subsidiary of Spyker
Cars NV, a publicly traded Netherlands corporation. In 2008, when
Spyker Automobielen B.V. was granted a limited extension of its
temporary exemption, Spyker Cars NV had no ownership interest in any
other vehicle manufacturer nor was it under any common control with
another automobile manufacturer.\7\ Since that time, Spyker Cars NV has
acquired Saab Automobile AG, a large Swedish car manufacturer. Spyker
asserts that Spyker Automobielen B.V. is financially and operationally
independent from Saab Automobile AG and that, based on past NHTSA
determinations regarding the issue of sponsorship, Spyker Automobielen
B.V. remains eligible for a temporary exemption based on economic
hardship.
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    \7\ See 74 FR 12926-27.
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    Since filing its petition, Spyker has informed the agency that
Spyker Cars NV plans to sell Spyker Automobielen B.V. to CPP Global
Holdings, a private holding company in the United Kingdom. Because of
the relationship between Spyker Automobielen B.V., Spyker Cars NV, and
Saab Automobile AG, and, in light of the plans to sell Spyker
Automobielen B.V. to CPP Global Holdings, NHTSA will closely examine
whether Spyker is eligible for a financial hardship exemption. NHTSA
specifically requests comments on the issue of Spyker's eligibility.
    Economic Hardship--Spyker stated that its previously established
financial hardship \8\ continues due to the worldwide economic
recession, which resulted in fewer global sales than Spyker had
predicted. Specifically, Spyker suffered a net operating loss of
approximately 131,971,000 Euros ($171,562,300) \9\ from 2004 to 2009.
Spyker projected a further loss in 2010 of 12,000,000 Euros
($15,600,000). Moreover, based on 2011-2013 projections, Spyker
estimated that if the extension is denied, Spyker will bear a loss of
over 32,465,000 Euros ($42,204,500) during that time, as opposed to a
loss of approximately 8,132,000 Euros ($10,571,600) if the extension is
granted, representing a difference of 24,333,000 Euros ($31,632,900).
Spyker also stated that the loss of sales in the U.S. that would result
if the extension is denied could not be made up in the rest of the
world because the U.S. is the largest and most important market for the
vehicle. Spyker argued that such consequences demonstrate ``substantial
economic hardship'' within the meaning of 49 U.S.C. 30113(b)(3)(B)(i).
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    \8\ See 74 FR 12925.
    \9\ All dollar values are based on an exchange rate of 1 Euro =
$1.30.
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    Good Faith Efforts to Comply--Spyker stated that when it filed its
original petition for exemption in 2004, its C line vehicles had no air
bags. Spyker indicated that it started developing an ``interim'' driver
air bag system for the C line vehicles, which went into production in
December 2007. Additionally, Spyker stated that it began development of
an ``interim'' passenger air bag for the C line in April 2007, which
went into production in March 2008.
    Spyker indicated that its ``interim'' air bag system is capable of
dual performance and meets the 35 mph belted test for both the driver
and passenger positions. Spyker stated that this latter achievement
brings its vehicles into compliance with paragraph S14.7 of FMVSS No.
208 (35 mph belted test using 5th percentile adult female dummies) two
years ahead of the September 1, 2012 deadline. Additionally, Spyker
indicated that its C8 vehicle meets the requirements of S14.5, S15, and
S17. However, Spyker stated that the ``interim'' air bag system still
cannot meet all of the advanced air bag requirements.
    Spyker stated that it is continuing to work with Continental to
develop and test its advanced air bag system and expects compliance by
May 15, 2012. In support of its statements, Spyker submitted a detailed
schedule for development of the advanced air bag system showing
completion by May 2012. Spyker stated that it investigated using Saab
facilities and equipment to develop its advanced air bag systems, but
the company decided to continue working with Continental.
    Public Interest--The petitioner put forth several arguments in
favor of a finding that the requested exemption is consistent with the
public interest and would not have a significant adverse impact on
safety. Specifically:
    1. Spyker stated that the exempted vehicles will comply with all
FMVSSs other than the provisions that are the subject of this extension
request.
    2. The petitioner stated that an exemption will benefit U.S.
employment and U.S. companies because Spyker vehicles are distributed

by a U.S. company, Spyker of North America, and are sold and serviced
in the U.S. through a network of 18 dealers. Spyker argued that denial
of an extension will negatively impact these companies.
    3. Spyker argued that if the exemption is not granted, U.S.
consumer choice would be harmed and that the agency has long maintained
that the National Traffic and Motor Vehicle Safety Act seeks, if
possible, to avoid limiting consumer choice.
    4. The petitioner argued that given their exotic design and high-
performance nature, the C line vehicles are not expected to be used
extensively, nor are they expected to carry children with any
frequency.
    NHTSA specifically invites comment on the likelihood that a child
or infant will be a passenger in a Spyker vehicle sold in the U.S.
    5. Spyker stated that as of the submission date of its application
for extension, approximately 60 exempted C line vehicles have been
imported into the U.S. and there have been no reports of any air bag-
related injuries.
    6. Spyker stated that an important safety feature that the C line
vehicles offer is enhanced occupant protection. The petitioner stated
that occupants are positioned in a protective ``cell'' because the main
chassis structure is built around them.
    Agency Review of Petition--Upon receiving a petition, NHTSA
conducts an initial review of the petition with respect to whether the
petition is complete and whether the petitioner appears to be eligible
to apply for the requested exemption. The agency has tentatively
concluded that the petition is complete. The agency has not made any
judgment on the eligibility of the petitioner or the merits of the
application, and is placing a non-confidential copy of the petition in
the docket.

IV. Issuance of Notice of Final Action

    We are providing a 30-day comment period. After considering public
comments and other available information, we will publish a notice of
final action on the application in the Federal Register.

    Issued on: March 31, 2011.
Joseph S. Carra,
Acting Associate Administrator for Rulemaking.
[FR Doc. 2011-8082 Filed 4-5-11; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 77, Number 13 (Friday, January 20, 2012)]
[Proposed Rules]
[Pages 2941-2943]
[FR Doc No: 2012-1120]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2011-0818; FRL-9619-7]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Determinations of Clean Data for the 2006 24-Hour Fine
Particulate Standard for the Harrisburg-Lebanon-Carlisle-York,
Allentown, Johnstown, and Lancaster Nonattainment Areas

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to determine that the Harrisburg-Lebanon-
Carlisle-York, Allentown, Johnstown, and Lancaster nonattainment areas
(hereafter referred to as ``Areas'') for the 2006 24-hour fine
particulate matter (PM2.5) National Ambient Air Quality
Standard (NAAQS) have clean data for the 2006 24-hour PM2.5
NAAQS. These proposed determinations are based upon quality-assured,
quality-controlled, and certified ambient air monitoring data showing
that these areas have monitored attainment of the 2006 PM2.5
NAAQS based on the 2008-2010 data available in EPA's Air Quality System
(AQS) database. If these proposed determinations are made final, the
requirements for these Areas to submit an attainment demonstration,
associated reasonably available control measures (RACM), a reasonable
further progress plan (RFP), contingency measures, and other planning
State Implementation Plans (SIPs) related to attainment of the standard
shall be suspended for so long as these Areas continue to meet the 2006
24-hour PM2.5 NAAQS. This action is being taken under the
Clean Air Act (CAA).

DATES: Written comments must be received on or before February 21,
2012.

ADDRESSES: Submit your comments regarding the two-state Harrisburg-
Lebanon-Carlisle-York, Allentown, Johnstown, and Lancaster area,
identified by Docket ID Number EPA-R03-OAR-2011-0818 by one of the
following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2011-0818, Cristina Fernandez, Associate
Director, Office of Air Program Planning, Mailcode 3AP30, 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-
2011-0818. 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 email. 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 email comment
directly to EPA without going through www.regulations.gov, your email
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.

FOR FURTHER INFORMATION CONTACT: Irene Shandruk,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.
    The following outline is provided to aid in locating information in
this preamble.

I. What action is EPA taking?
II. What is the effect of this action?
III. What is the background for this action?
IV. What is EPA's analysis of the relevant air quality data?
V. What is EPA's proposed action?
VI. Statutory and Executive Order Reviews

I. What action is EPA taking?

    EPA is proposing to determine that these Areas have clean data for
the 2006 24-hour PM2.5 NAAQS. These determinations are based
upon quality-assured, quality-controlled, and certified ambient air
monitoring data showing that these Areas have monitored attainment of
the 2006 PM2.5 NAAQS based on 2008-2010 monitoring data.

II. What is the effect of this action?

    If these determinations are made final, under the provisions of
EPA's PM2.5 implementation rule (40 CFR 51.1004(c)), the
requirements for these Areas to submit an attainment demonstration,
associated RACM, RFP plan, contingency measures, and any other planning
SIP requirements related to attainment of the 2006 24-hour
PM2.5 NAAQS would be suspended for so long as these Areas
continue to meet this NAAQS. Furthermore, as described below, a final
clean data determination would not be equivalent to a redesignation of
any of these Areas to attainment for the 2006 24-hour PM2.5
NAAQS.
    If EPA subsequently determines that these Areas are in violation of
the 2006 24-hour PM2.5 NAAQS, the basis for the suspension
of the specific requirements, set forth at 40 CFR 51.1004(c), would no
longer exist and these Areas would thereafter have to address the
pertinent requirements.
    These proposed clean data determinations that the air quality data
shows attainment of the 2006 24-hour PM2.5 NAAQS is not
equivalent to the redesignation of these Areas to attainment. This
proposed action, if finalized, will not constitute a redesignation to
attainment under section 107(d)(3) of the CAA because we would not yet
have an approved

maintenance plan for these Areas as required under section 175A of the
CAA, nor determinations that these Areas have met the other
requirements for redesignation. The designation status of these Areas
would remain nonattainment for the 2006 PM2.5 NAAQS until
such time as EPA determines that these Areas meet the CAA requirements
for redesignation to attainment.

III. What is the background for this action?

    The 2006 PM2.5 NAAQS set forth at 40 CFR 50.13 became
effective on December 18, 2006 (71 FR 61144) and promulgated a 24-hour
standard of 35 micrograms per cubic meter ([mu]g/m\3\) based on a 3-
year average of the 98th percentile of 24-hour concentration. On
December 14, 2009 (74 FR 58688), EPA made designation determinations,
as required by CAA section 107(d)(1), for the 2006 24-hour
PM2.5 NAAQS. The Harrisburg-Lebanon-Carlisle-York,
Allentown, Johnstown, and Lancaster areas are designated as
nonattainment for the 2006 24-hour PM2.5 NAAQS.

IV. What is EPA's analysis of the relevant air quality data?

    EPA has reviewed the ambient air monitoring data, consistent with
the requirements contained in 40 CFR part 50 and recorded in EPA's AQS
database for the Harrisburg-Lebanon-Carlisle-York, Allentown,
Johnstown, and Lancaster PM2.5 nonattainment areas from 2008
through the present time. On the basis of that review, EPA has
concluded that these Areas meet the 2006 24-hour PM2.5 NAAQS
based on the 2008-2010 data available in EPA's AQS database.
    Under EPA regulations in 40 CFR part 50, section 50.13 and in
accordance with appendix N, the 24-hour primary and secondary
PM2.5 standards are met when the 98th percentile 24-hour
concentration is less than or equal to 35 [mu]g/m\3\. Table 1 shows the
design values for the 2006 24-hour PM2.5 NAAQS for the years
2008-2010. One new monitor (ID 420950027) was placed in 2010
in the Allentown nonattainment area because the 2006-2008 data for the
existing monitor (ID 420950025) in the area was greater than
85% of the 24-hour PM2.5 NAAQS as required by 40 CFR part
58, appendix D, Table D-5. EPA's review of the data indicates that the
Harrisburg-Lebanon-Carlisle-York, Allentown, Johnstown, and Lancaster
PM2.5 nonattainment areas meet the 2006 PM2.5
NAAQS.

                                        Table 1--24-Hour PM2.5 Values for Four Pennsylvania Nonattainment Areas *
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                                                                                Certified
                                                                                2008 Mean       2009 Mean       2010 Mean     design value
                State                           County                  Monitor ID         ([mu]g/m\3\)    ([mu]g/m\3\)    ([mu]g/m\3\)      2008-2010
                                                                                ([mu]g/m\3\)
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                                                            Harrisburg-Lebanon-Carlisle-York
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Pennsylvania.........................  Cumberland..............  420410101..............            33.7            29.9            31.4              32
                                       Dauphin.................  420430401..............            34.3            33.0            32.9              33
                                       Lebanon.................  No monitor.............  ..............  ..............  ..............  ..............
                                       York....................  No monitor.............  ..............  ..............  ..............  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Allentown
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       Northampton.............  420950025..............            33.1            30.1            33.3              32
                                       Northampton.............  420950027..............  ..............  ..............            27.6              28
                                       Lehigh..................  No monitor.............  ..............  ..............  ..............  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Johnstown
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       Cambria.................  420210011..............            32.2            28.7            30.2              30
                                       Indiana (part)..........  No monitor.............  ..............  ..............  ..............  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Lancaster
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       Lancaster...............  420710007..............            35.0            29.4            34.1              33
--------------------------------------------------------------------------------------------------------------------------------------------------------
* The data presented in Table 1 are available at http://www.epa.gov/air/airtrends/values.html.

V. What is EPA's proposed action?

    EPA is proposing to determine that the Areas have clean data for
the 2006 24-hour PM2.5 NAAQS. As provided in 40 CFR
51.1004(c), if EPA finalizes these determinations, they will suspend
the requirements for these Areas to submit an attainment demonstration,
associated RACM, RFP, contingency measures, and any other planning SIP
requirements related to the attainment of the 2006 PM2.5
NAAQS, so long as these Areas continue to meet the standard. EPA is
soliciting public comments on the issues discussed in this document.
These comments will be considered before taking final action.

VI. Statutory and Executive Order Reviews

    This action proposes to make attainment determinations based on air
quality data and would not, if finalized, result in the suspension of
certain Federal requirements and would not impose any additional
requirements. 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 rulemaking that the Harrisburg-Lebanon-
Carlisle-York, Allentown, Johnstown, and Lancaster PM2.5
nonattainment areas have clean data for the 2006 24-hour
PM2.5 standard 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, Particulate
matter, Reporting and recordkeeping requirements.

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

    Dated: January 3, 2012.
W.C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2012-1120 Filed 1-19-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 183 (Friday, September 20, 2019)]
[Notices]
[Pages 49530-49535]
[FR Doc No: 2019-20372]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3403]

The Food and Drug Administration Solicits Input on Potential Role
for Abuse-Deterrent Formulations of Central Nervous System Stimulants;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

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

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

SUMMARY: The Food and Drug Administration (FDA) is establishing a
public docket to receive comments from interested parties, including
patients, patient advocates, healthcare providers, academics,
researchers, the pharmaceutical industry, and other government
entities, on considerations related to the development and evaluation
of abuse-deterrent formulations (ADFs) of central nervous system
stimulants and whether such products could play a role in addressing
public health concerns related to prescription stimulant misuse and
abuse. This notice provides an overview of available postmarket data on
the use, misuse, and abuse of prescription stimulants and associated
morbidity and mortality, along with similar data on prescription
opioids to provide context; background information on the development
and evaluation of ADF products; and specific questions on which FDA
seeks input. The Appendix lists the sources used in developing this
overview.

DATES: Submit either electronic or written comments by November 19,
2019.

ADDRESSES: FDA is establishing a docket for public comment. The docket
number is FDA-2019-N-3403. The docket will close on November 19, 2019.
Please note that late, untimely filed comments will not be considered.
Electronic comments must be submitted on or before November 19, 2019.
The https://www.regulations.gov electronic filing system will accept
comments until 11:59 p.m. Eastern Time at the end of November 19, 2019.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.
    You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and

Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-3403 for ``FDA Solicits Input on Potential Role for Abuse-
Deterrent Formulations of Central Nervous System Stimulants;
Establishment of a Public Docket; Request for Comments.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Janelle Derbis, Center for Drug
Evaluation and Research (HFD-1), Food and Drug Administration, 20 North
Michigan Ave., Suite 510, Chicago, IL 60602,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Introduction

    Prescription central nervous system (CNS) stimulants are important
medications that are widely prescribed for the treatment of attention
deficit hyperactivity disorder (ADHD) and, in some cases, narcolepsy.
Currently marketed prescription stimulant drugs consist primarily of
amphetamine salts and related compounds including methylphenidate,
dextroamphetamine, dexmethylphenidate, methamphetamine, and
lisdexamfetamine. When used properly, prescription stimulants can
provide significant benefits for patients. However, these drugs have a
high potential for misuse and abuse,\1\ with associated morbidity and
mortality. As such, these drugs are classified in Schedule II (CII)
under the Controlled Substances Act, the most restrictive
classification for drugs with currently accepted medical use in the
United States.
---------------------------------------------------------------------------

    \1\ In this document, the term misuse refers to the intentional
therapeutic use of a drug product in an inappropriate way and
specifically excludes the definition of abuse. The term abuse is
used here to mean the intentional, non-therapeutic use of a drug
product or substance, even once, to achieve a desirable
psychological or physiological effect.
---------------------------------------------------------------------------

    Over the past several years, drug manufacturers have sought to
develop novel formulations of prescription stimulants with properties
intended to deter abuse. The purpose of this Federal Register notice is
to solicit input on considerations related to the development and
evaluation of such potentially abuse-deterrent formulations, referred
to in this notice as ADF stimulants, and whether such products could
play a role in addressing public health concerns related to
prescription stimulant misuse and abuse. We note that although FDA has
approved multiple opioid analgesic products with ADFs with labeling
stating that these products are expected to deter abuse via one or more
routes of administration, FDA has not approved similar labeling for any
prescription stimulants. FDA recognizes the misuse and abuse of
prescription stimulants as serious public health concerns. However, the
scope and patterns of misuse and abuse, morbidity, and mortality
associated with prescription stimulants are different from those
associated with prescription opioids. Furthermore, postmarket data
regarding the impact of ADF opioid analgesics in reducing abuse and
associated adverse health outcomes, such as overdose, continue to be
limited. FDA is interested in public comment on whether and to what
extent ADF stimulants might reduce prescription stimulant abuse and on
the potential public health impact of any such reduction.

II. Background

    To better understand the potential role for ADF stimulant products,
FDA has reviewed available postmarket data on patterns of use, misuse,
and abuse of prescription stimulants and associated morbidity and
mortality. A summary of these findings is presented below. To provide
context, we also include selected similar data on prescription opioids
(see the Appendix for the sources used to develop this summary).
Finally, we briefly describe certain key concepts associated with the
development and evaluation of drug products intended to deter abuse.

A. Postmarket Data on Use, Misuse, Abuse, and Related Adverse Health
Outcomes

    Amphetamine stimulants have been available and used for various
medical purposes for roughly a century. In the 1990s, longer acting
forms of amphetamine were introduced to the market. During this same
period, a steep increase in the diagnosis of ADHD in the United States
led to a parallel increase in societal exposure to prescribed
amphetamine and related stimulant products. From 2007 to 2016, the
number of individuals receiving prescriptions for stimulants increased
substantially in patients older than 4 years old, with the greatest
rate increases occurring in those aged 25 to 44 years. From 2012 to
2016, the estimated number of prescriptions dispensed annually for CII
stimulant products from U.S. outpatient retail pharmacies increased
from approximately 49.2 million to 62.8 million prescriptions. During
this same period, the estimated number of prescriptions dispensed for
opioid analgesics decreased from approximately 238.2 million to 193.4
million, remaining approximately three times that of CII stimulant
product prescriptions dispensed in 2016.
    College students and other young adults are the demographic groups
with the highest prevalence of misuse and abuse of prescription
stimulants. Data

from the National Survey on Drug Use and Health (2017) suggest that
among Americans aged 12 years and older, an estimated 6.8 percent have
used a prescription stimulant in the past year, and 2.1 percent have
misused or abused a prescription stimulant. Among those aged 18 to 25
years, an estimated 14.7 percent have used a prescription stimulant in
the past year, and 7.4 percent report misusing or abusing the
medications. By comparison, among those 12 years and older, an
estimated 33.4 percent used and 4.1 percent misused or abused
prescription opioid analgesics in the past year. Among 18- to 25-year-
olds, an estimated 29.9 percent used prescription opioid analgesics in
the past year, and 7.2 percent reported misusing or abusing the
medications.
    Most individuals misusing or abusing prescription stimulants report
doing so only occasionally, primarily to stay awake or enhance academic
or work performance, rather than to achieve a high. Those who misuse
and abuse prescription stimulants commonly do so in the setting of
polysubstance abuse involving a wide range of other prescription
products and illicit substances. Limited data from surveys of college
students suggest that the problem of prescription stimulant misuse and
abuse may be growing in this population, although the prevalence
appears to vary considerably by geographic region. Recent data from
U.S. poison control centers suggest that misuse and abuse of
prescription stimulants may be declining among adolescents less than 19
years of age.
    In surveys, a large majority of college students who misuse or
abuse prescription stimulants report doing so by the oral route.
However, a sizable minority report at least sometimes using them
intranasally (most estimates being between 10 percent and 30 percent,
but ranging from approximately 7 percent to 50 percent). Injection of
prescription stimulants appears to be very uncommon among college
students, although data are limited. Among individuals being assessed
for or entering substance abuse treatment--a population enriched with
individuals with advanced substance use disorders (SUDs)--about 2 in 5
respondents reporting misuse or abuse of prescription stimulants
indicate using them intranasally, and approximately 1 in 10 reports
injecting them. Direct comparisons with routes of abuse for
prescription opioids are difficult, because these patterns vary widely
across class, but the routes of abuse patterns for prescription
stimulants appear most similar to those seen in this population for
immediate-release oxycodone/acetaminophen combination products.
    A variety of serious adverse events have been reported in
association with prescription stimulant misuse and abuse, including
both acute and chronic cardiovascular and neuropsychiatric effects.
Additional serious complications are associated with abuse via non-oral
routes, including but not limited to, pulmonary complications and
infections from non-sterile injection practices and syringe sharing.
Misuse and abuse of prescription stimulants can result in physical and
psychological dependence as well as impairment of important family,
social, and occupational functioning.
    Despite these concerns, available data from emergency department
(ED) visits, drug-involved mortality, and treatment center admissions
suggest that serious consequences of prescription stimulant misuse and
abuse appear to be considerably less frequent than for prescription
opioids, even after accounting for the lower prescription volume of
stimulants. It is important to recognize that not all harms associated
with prescription drug misuse and abuse will be captured in these data
sources. Based on data from the National Electronic Injury Surveillance
System-Cooperative Adverse Drug Event Surveillance (NEISS-CADES)
project, in 2016, approximately 11,000 emergency department visits were
estimated to involve nonmedical use of prescription stimulants
(including both misuse and abuse), or approximately 1 visit for every
5,700 prescriptions dispensed. In the same year, approximately 130,000
visits were estimated to involve nonmedical use of opioid analgesics,
or 1 visit for every 1,500 prescriptions dispensed. Therefore, although
survey data indicate that the prevalence of prescription stimulant
misuse and abuse is similar to, or potentially even higher than, that
of opioid analgesics relative to prescribed availability, the ED visit
data suggest that the likelihood of acute adverse effects serious
enough to require medical evaluation or treatment is considerably lower
with prescription stimulants than with opioid analgesics. This finding
is not surprising given the risk of profound central nervous system and
respiratory depression associated with opioids.
    Similarly, deaths involving prescription opioids vastly outnumber
those involving prescription stimulants, despite the only modestly
higher prescription volume for opioids. Based on data extracted from
the text of U.S. death certificates, in 2014, approximately 1,000
deaths involved prescription stimulants (including mention of
``amphetamines'' and other prescription stimulants but excluding
``methamphetamine''), or 1 death for every 55,000 prescriptions. By
comparison, in 2014, more than 14,000 deaths involved prescription
opioids, about 1 death for every 16,000 prescriptions dispensed.
    Data from SUD treatment center admissions indicate that
prescription stimulants are a relatively uncommon drug of abuse
reported among those entering treatment for SUDs (<2 percent),
particularly when compared to prescription opioids (approximately 8 to
20 percent). However, as these data capture only a snapshot of recent
drug use reported by people being assessed for treatment, they shed
little light on the natural history of drug abuse and the development
of SUDs, which often involve multiple drugs. Although there is a small
body of literature on the progression of opioid use disorder and
transitions from prescription opioids to heroin, there has been little
research on the longitudinal trajectory of prescription stimulant
misuse and abuse, the development of addiction among those misusing or
abusing these drugs, or the likelihood of transitioning to illicit
stimulants, such as methamphetamine and cocaine, which represent a
large and growing public health concern.
    In summary, prescription stimulant misuse and abuse are serious
public health concerns, particularly in college students and other
young adults. Most misuse and abuse of these drugs is oral, although a
significant minority of those misusing and abusing the medications
report non-oral routes, primarily intranasal. The risk of serious
adverse outcomes and the overall magnitude of harms associated with
prescription stimulants appear to be considerably lower than for
prescription opioids. The relationship between misuse and abuse of
prescription stimulants and the development of addiction or initiation
of illicit stimulants, such as methamphetamine and cocaine, or other
substances, has not been well characterized.

B. Development and Evaluation of ADF Products

    Some examples of types of abuse-deterrent technologies and methods
for evaluating ADFs are outlined in FDA's 2015 guidance for industry
entitled ``Abuse-Deterrent Opioids--Evaluation and Labeling''
(available at https://www.fda.gov/media/84819/download). While this
document was not intended to provide guidance on the development or
evaluation of abuse-deterrent

products in other drug classes, it outlines certain principles that
would likely be relevant to the development and evaluation of abuse-
deterrent formulations of any prescription drug product. For example,
the guidance explains that the design of relevant abuse-deterrent
products should target specific known or expected routes of abuse
relevant to the proposed product. In addition, the guidance recommends
that an evaluation of a proposed ADF should take into consideration the
known routes of abuse for the non-ADF predecessor or similar products,
and that an ADF should meaningfully reduce abuse of the product as well
as morbidity and mortality associated with that abuse. The potential
for an ADF to reduce abuse and misuse of a drug product and associated
harms depends on, among other things, the pharmacologic properties and
abuse liability of the drug substance itself, the scope and patterns of
abuse and related harms for that drug and other drugs in the community,
and the effectiveness of the ADF in actually deterring abuse and
reducing related adverse outcomes associated with that drug in real-
world settings. The guidance recommends that developers of ADF products
should also consider possible unintended consequences of the ADF, such
as the possibility that the ADF could result in shifting abuse from one
route to a different, riskier route (e.g., from snorting to injecting).
    Although certain scientific principles described in the 2015
guidance likely would be relevant to the development and evaluation of
abuse-deterrent formulations of any prescription drug product, FDA has
not determined that ADF stimulants warrant the same regulatory approach
as ADF opioids. FDA has approved several ADF opioids with language in
product labeling stating that these products are expected to deter
abuse via specific routes of administration, but has not approved
similar labeling for any prescription stimulants. As discussed above,
both the patterns and magnitudes of misuse and abuse, morbidity, and
mortality associated with prescription stimulants are quite different
from those associated with prescription opioids. Furthermore, FDA is
continuing to refine its regulatory approach towards ADF opioids in
light of evolving technology and science as well as the changing nature
of the opioid crisis. While some stakeholders have called for FDA to
take additional actions to encourage the transition of the prescription
opioid market to ADF opioids, others have questioned the effectiveness
of ADFs in reducing opioid abuse and have raised concerns about the
possibility of unintended consequences of such a transition, including
higher costs and the potential to shift abuse to even more dangerous
illicit drugs.

C. Topics for Consideration

    (1) FDA has provided a summary of its current understanding of
abuse and misuse of prescription stimulant products in the United
States. We are seeking new or additional information and perspectives
on prescription stimulant misuse and abuse and associated harms. We are
particularly interested in data on the natural history of stimulant use
disorders, including the risk of developing addiction and of
transitioning to abuse of illicit stimulants.
    (2) Taking into account the patterns and consequences of
prescription stimulant misuse and abuse by both patients and others who
may access the drugs, discuss whether ADF stimulants could be expected
to meaningfully reduce prescription stimulant abuse and associated
harms. For which specific patient populations, if any, might it be
beneficial to prescribe ADF stimulants? In particular, please discuss
whether and to what extent ADF stimulants might be expected to deter
the various routes of abuse (e.g., oral, intranasal, injection)
associated with prescription stimulants, and also whether such
products, if approved and marketed, could be expected to meaningfully
reduce the incidence or progression of stimulant use disorder.
    (3) Please comment on how ADF stimulant products should be
evaluated in premarket and postmarket studies to determine whether they
can be expected to deter, or actually have deterred, abuse by the
various routes associated with prescription stimulant abuse (oral,
intranasal, intravenous, inhalation).
    (4) Comment on whether the potentially abuse-deterrent properties
of ADF stimulants should be described in product labeling. If so, how
should they be described and based on what evidence? We additionally
invite comment on whether terms such as abuse deterrent stimulant and
ADF stimulant could be misinterpreted by the public (including
prescribers) to suggest that a product is ``abuse-proof,'' or carries a
lower risk of addiction. Is there alternative terminology that FDA
could use to more clearly describe the expected effects of these new
formulations in terms of patient safety and public health?
    (5) What other actions or regulatory approaches with respect to ADF
stimulants should FDA consider?
    (6) Comment on any potential unintended consequences of introducing
ADF stimulants to the market. For example, what is the potential for
ADF stimulants to shift behavior toward more dangerous routes of abuse
(i.e., injection) or to more dangerous drugs (e.g., illicit
methamphetamine or other substances), or to result in increased costs
for patients, payers, or health systems?
    (7) What other actions, if any, should FDA consider to reduce
misuse, abuse, and related harms associated with prescription
stimulants?

III. Appendix

    The following sources were used in developing the body of this
notice.

Albertson, T.E., W.F. Walby, and R.W. Derlet. (1995) ``Stimulant-
Induced Pulmonary Toxicity.'' Chest, 108(4): 1140-1149.
Arria, A.M., K.M. Caldeira, K.E. O'Grady, et al. (2008) ``Nonmedical
Use of Prescription Stimulants Among College Students: Associations
With Attention-Deficit-Hyperactivity Disorder and Polydrug Use.''
Pharmacotherapy, 28(2): 156-169. doi: 10.1592/phco.28.2.156.
Bachi, K., S. Sierra, N.D. Volkow, et al. (2017) ``Is Biological
Aging Accelerated in Drug Addiction?'' Current Opinion in Behavioral
Sciences, 13: 34-39.
Berman, S.M., R. Kuczenski, J.T. McCracken, et al. (2009)
``Potential Adverse Effects of Amphetamine Treatment on Brain and
Behavior: A Review.'' Molecular Psychiatry, 14(2): 123-142. doi:
10.1038/mp.2008.90.
Bruggisser, M., M. Bodmer, and M.E. Liechti. (2011) ``Severe
Toxicity due to Injected but not Oral or Nasal Abuse of
Methylphenidate Tablets.'' Swiss Medical Weekly, 141: w13267. doi:
10.4414/smw.2011.13267.
Butler, S.F., T.A. Cassidy, H. Chilcoat, et al. (2013) ``Abuse Rates
and Routes of Administration of Reformulated Extended-Release
Oxycodone: Initial Findings From a Sentinel Surveillance Sample of
Individuals Assessed for Substance Abuse Treatment.'' The Journal of
Pain, 14: 351-358.
Butler, S.F., R.A. Black, T.A. Cassidy, et al. (2011) ``Abuse Risks
and Routes of Administration of Different Prescription Opioid
Compounds and Formulations.'' Harm Reduction Journal, 8: 29.
Carlson R.G., R.W. Nahhas, S.S. Martins, et al. (2016) ``Predictors
of Transition to Heroin Use Among Initially Non-Opioid Dependent
Illicit Pharmaceutical Opioid Users: A Natural History Study.'' Drug
and Alcohol Dependence, 160: 127-134.
Carroll, B.C., T.J. McLaughlin, and D.R. Blake. (2006) ``Patterns
and Knowledge of Nonmedical Use of Stimulants Among College
Students.'' Archives of Pediatrics & Adolescent Medicine, 160: 481-
485.
Cassidy, T.A., N. Oyedele, T.C. Mickle, et al. (2017) ``Patterns of
Abuse and Routes of Administration for Immediate-Release Hydrocodone
Combination Products.'' Pharmacoepidemiology and Drug Safety,

26: 1071-1082.
Cassidy, T.A., E.C. McNaughton, S. Varughese, et al. (2015)
``Nonmedical Use of Prescription ADHD Stimulant Medications Among
Adults in a Substance Abuse Treatment Population: Early Findings
From the NAVIPPRO Surveillance System.'' Journal of Attention
Disorders, 19(4): 275-283.
Cassidy, T.A., S. Varughese, L. Russo, et al. (2015) ``Nonmedical
Use and Diversion of ADHD Stimulants Among U.S. Adults Ages 18-49: A
National internet Survey.'' Journal of Attention Disorders, 19(7):
630-640.
Center for Behavioral Health Statistics and Quality. (2018) ``2017
National Survey on Drug Use and Health: Detailed Tables. Substance
Abuse and Mental Health Services Administration,'' Rockville, MD.
Available at: https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHDetailedTabs2017/NSDUHDetailedTabs2017.pdf.
Centers for Disease Control, ``Drug Involved Mortality Restricted
Variable.'' (2019) (see ``DIM Documentation pdf'' in link; Food and
Drug Administration. ``Analysis of Drug-Involved Mortality Data,''
October 2016.) Available at: https://www.cdc.gov/rdc/b1datatype/dt1229.html.
Clegg-Kraynok, M.M., A.L. McBean, and H.E. Montgomery-Downs. (2011)
``Sleep Quality and Characteristics of College Students Who Use
Prescription Psychostimulants Nonmedically.'' Sleep Medicine, 12(6):
598-602. doi: 10.1016/j.sleep.2011.01.012.
DeSantis, A.D., E.M. Webb, and S.M. Noar. (2008) ``Illicit Use of
Prescription ADHD Medications on a College Campus: A
Multimethodological Approach.'' Journal of American College Health,
57(3): 315-324. doi: 10.3200/JACH.57.3.315-324.
Dupont, R.L., J.J. Coleman, R.H. Bucher, et al. (2008)
``Characteristics and Motives of College Students Who Engage in
Nonmedical Use of Methylphenidate.'' The American Journal on
Addictions, 17(3): 167-171. doi: 10.1080/10550490802019642.
Garnier-Dykstra, L.M., K.M. Caldeira, K.B. Vincent, et al. (2012)
``Nonmedical Use of Prescription Stimulants During College: Four-
Year Trends in Exposure Opportunity, Use, Motives, and Sources.''
Journal of American College Health, 60(3): 226-234. doi: 10.1080/
07448481.2011.589876.
Geller, A.I., D. Dowell, M.C. Lovegrove, et al. (2019) ``U.S.
Emergency Department Visits Resulting From Nonmedical Use of
Pharmaceuticals, 2016.'' American Journal of Preventive Medicine,
56: 639-647.
Ghuran A. and J. Nolan. (2000) ``Recreational Drug Misuse Issues for
the Cardiologist.'' Heart, 83(6): 627-633.
Guarino, H., P. Mateu-Gelabert, J. Teubl, et al. (2018) ``Young
Adults' Opioid Use Trajectories: From Nonmedical Prescription Opioid
Use to Heroin, Drug Injection, Drug Treatment and Overdose.''
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    Dated: September 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20372 Filed 9-19-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: February 16, 2006 (Volume 71, Number 32)]
[Notices]
[Page 8291-8292]
[DOCID:fr16fe06-51]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-211-000]

Dominion Cove Point LNG, LP; Notice of Proposed Changes in FERC
Gas Tariff

February 9, 2006.
    Take notice that on February 3, 2006, Dominion Cove Point LNG, LP
(Cove Point) tendered for filing as part of its FERC Gas Tariff,
Original Volume No. 1, Second Revised Sheet No. 283, to become
effective March 6, 2006.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the

``eFiling'' link at http://www.ferc.gov. Persons unable to file

electronically should submit an original and 14 copies of the protest
or intervention to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-2251 Filed 2-15-06; 8:45 am]

BILLING CODE 6717-01-P