[Federal Register Volume 84, Number 124 (Thursday, June 27, 2019)]
[Notices]
[Pages 30721-30724]
[FR Doc No: 2019-13758]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0075]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental Study on
Measuring Consumer Comprehension of Displays of Harmful and Potentially
Harmful Constituents in Tobacco Products and Tobacco Smoke

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA 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.

DATES: Fax written comments on the collection of information by July
29, 2019.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-NEW and
title ``Experimental Study on Measuring Consumer Comprehension of
Displays of Harmful and Potentially Harmful Constituents in Tobacco
Products and Tobacco Smoke.'' Also include the FDA docket number found
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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.
    Experimental Study on Measuring Consumer Comprehension of Displays
of Harmful and Potentially Harmful Constituents in Tobacco Products and
Tobacco Smoke OMB Control Number 0910-NEW

I. Background

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control
Act (Pub. L. 111-31) (Tobacco Control Act) was signed into law. This
law amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and
granted FDA the authority to regulate the manufacture, marketing, and
distribution of cigarettes, cigarette tobacco, roll-your-own tobacco,
and smokeless tobacco products to protect the public health and to
reduce tobacco use by minors. The Tobacco Control Act also gave FDA the
authority to issue regulations deeming other products that meet the
statutory definition of a tobacco product to be subject to chapter IX
of the FD&C Act (section 901(b) of the FD&C Act (21 U.S.C. 387a(b))).
    In accordance with that authority, on May 10, 2016 (81 FR 28974),
FDA issued a final rule deeming all products that meet the statutory
definition of tobacco product, except accessories of newly deemed
tobacco products, to be subject to FDA's tobacco product authority. The
deemed products include electronic nicotine delivery systems, cigars,
waterpipe (hookah), pipe tobacco, nicotine gels, dissolvables that were
not already subject to the FD&C Act, and other tobacco products that
may be developed in the future.
    Among other requirements, section 904(e) of the FD&C Act (21 U.S.C.
387d(e)) requires FDA to establish, and periodically revise as
appropriate, a list of harmful and potentially harmful constituents
(HPHCs), including smoke constituents, to health in each tobacco
product by brand and by quantity in each brand and subbrand. Section
904(d)(1) of the FD&C Act further requires that this list be published
in a format that is understandable and not misleading to a lay person
(the Section 904(d) list).
    FDA has undertaken a rigorous science-based research approach to
ensure that the Section 904(d) list is not misleading to lay persons.
As part of this research, FDA is seeking to conduct an experimental/
quantitative study (4,500 online surveys), consisting of adult and
youth (aged 13 to17) participants to evaluate the best way to convey
information about HPHCs in tobacco products and tobacco smoke, by brand
and by quantity in each brand and subbrand, in a format that is
understandable and not misleading to a lay person. Participants will
view sample formats and complete an online survey that will include
questions regarding their understanding of the HPHC information
presented to them. The purpose of the research is to gain insight on
consumer comprehension of, and preferences regarding, HPHC
presentations that will inform the Agency's efforts in connection with
publishing the Section 904(d) list.
    In the Federal Register of February 11, 2019 (84 FR 3188), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received comments from six individuals
or organizations, three of which were PRA related.
    (Comment) One comment recommended that FDA make the study design,
sample formats, and all study measures available for public comment.
    (Response) FDA notes that the study protocol, list formats, and the
survey questionnaire are available for review upon request and are
described in detail as part of the overall information collection
request submitted to OMB for review.
    (Comment) One comment suggested that FDA add a control group that
does not view a sample format to our study design.
    (Response) FDA considered the utility of adding a no-exposure
control group to this study. However, FDA determined that this is not
in line with the study aims. The aims of the study are derived from
section 904(e) of the FD&C Act which requires FDA to publish a list of
HPHCs in each brand and sub-brand of tobacco product, in a way that
people find understandable and not misleading. Therefore, the proposed
study will test different formats of HPHC lists to meet this statutory
requirement. A condition in which people do not see a list of HPHCs in
a tobacco product does not approximate real-life conditions.
    (Comment) One comment suggested that FDA should clarify whether the
HPHC sample formats will include smokeless brands since items in the
draft survey are exclusive to cigarettes. The comment also noted that
FDA should clarify whether smokeless tobacco and exclusive cigarette
users will only view HPHC lists in their respective categories.
    (Response) HPHC sample formats will not include smokeless brands
because HPHC lists for cigarettes are the focus of the proposed study.
All participants will view HPHC lists for cigarettes only to allow for
a parsimonious and focused design that is adequately powered to detect
effects.
    (Comment) One comment suggested that FDA should use validated
survey measures, establish the validity of other metrics prior to use,
and consider using validated risk perception metrics.
    (Response) FDA agrees that validated items should be used whenever
possible. FDA engaged in a multistep process to select validated survey
items for this study. First, FDA conducted a literature review and used
available validated survey measures, including measures from past HPHC
research (Ref. 1). However, for some outcomes (e.g., knowledge about
the tested format), validated measures do not exist because questions
are specific to the stimuli. Second, FDA conducted qualitative research
to inform our measures. Based on insights uncovered during this
research, we created and modified survey items. Third, FDA conducted
cognitive testing to refine the measures. It should be noted that there
are many ways to measure these constructs, including harm perceptions.
The harm perceptions items that FDA used are based on a systematic
review that identified the most commonly measured tobacco-related
health consequences in the literature (Ref. 2).
    (Comment) One comment suggested that FDA should get end-user input
into the development and refinement of the survey items. The comment
suggested that survey items should be subject to cognitive testing,
with individuals representing end users until the point of saturation
is reached.
    (Response) FDA agrees that it is important to test a survey before
collecting responses. As part of the research program, FDA conducted 54
indepth interviews, ``Consumer Comprehension of Displays of Harmful and
Potentially Harmful Constituents (HPHCs) in Tobacco Products'' (OMB
control number 0910-0796), as a first step to develop items. Based on
the findings from that study and a literature review to uncover
validated measures, FDA developed a draft survey. Next, FDA cognitively
tested the draft survey and stimuli and refined each by reducing
redundant content and editing any confusing items. FDA reached
saturation in both qualitative studies.
    (Comment) One comment suggested that including a midpoint on some
of the scales (e.g. ``neutral'' and ``neither agree nor disagree'') may
be difficult for some respondents to understand. The comment suggested
that FDA incorporate a ``don't know'' response option for some items
including the HPHC general knowledge questions.
    (Response) The inclusion of a ``don't know'' response on the
knowledge items was made in order to best match the source of those
items (Refs. 1 and 3). That is, FDA included a ``don't know'' option
when the source item did so. Although it is true that individuals
interpret middle options like ``neutral'' in different ways, these
personal interpretations should be randomly distributed across
condition and thus

not affect the comparisons among the stimuli (Ref. 4).
    (Comment) One comment recommended that FDA ask several of the post-
test items (e.g., items 33, 34, 38) during the pre-test so that we can
obtain a baseline estimate of misperceptions and determine whether
there was any change in respondents' incorrect beliefs following
exposure to the stimulus.
    (Response) The primary purpose of this study is to test formats to
see if they are understandable and not misleading. This can be achieved
by comparing post-test measures of understanding and misleading across
conditions and does not require a pre-test. We note that participants
may have baseline misperceptions that are not accounted for in this
design; however, since we are collecting data from a representative
sample of people, we can account for these differences during the
analysis. Further, as these items are part of a validated scale if FDA
selects only a few items to ask in the pre-test, this may lead to data
that is not reliable or valid. As these items are part of a larger
scale that has been used and tested in previous research, only
selecting a few questions may alter how participants respond to these
and other questions in the survey. Also, these items have not been
tested to be used alone.
    (Comment) One comment suggested that FDA add an attention check and
measures of believability, truthfulness, or skepticism to provide
additional context for the study results.
    (Response) The knowledge items in the survey are inherently an
attention check because the participant can use the information in the
stimulus to answer questions. Adding an attention check will not
provide any additional benefit. Adding additional measures about
believability, truthfulness, or skepticism are outside of the scope and
purpose of this study.
    (Comment) One comment suggested that FDA oversample vulnerable
populations including youth, minorities, and those with low levels of
education in our survey. An additional comment commended FDA for
including youth aged 13 to 17 in this study as it is critically
important because most tobacco consumers begin using tobacco before the
age of 18. Further, including youth in the sample underscores FDA's
recognition that it is possible to survey youth about the comprehension
of information about tobacco without violating ethical standards.
    (Response) FDA agrees, we have established quotas in the
recruitment to ensure that the sample is comprised of at least 20
percent of low socioeconomic participants (income of less than $25,000
year) and at least 20 percent of adults without a high school diploma
or GED. These proportions are not exclusive because low education and
low socioeconomic status are strongly correlated. Further, the study
sample will include approximately 1,500 adolescent tobacco users and
adolescents at risk for using tobacco (ages 13 to 17).
    (Comment) One comment suggested that FDA collect demographic
information pertaining to race/ethnicity, age, and education level.
    (Response) FDA agrees, we already plan to collect this demographic
information as part of the screening procedures.
    (Comment) One comment suggested that FDA ask participants where
they would look for information about tobacco constituents.
    (Response) FDA appreciates the suggestion. As previously mentioned
in our comment responses FDA conducted 54 indepth interviews where this
was assessed. There is also an item on the survey that asks, ``Where
would you most like to see information on chemicals in cigarettes and
cigarette smoke?'' The response options are ``on cigarette packs,''
``in stores,'' and ``online.'' Between this item and the indepth
interviews FDA conducted, this will provide FDA with adequate
information on where participants would look for information about
tobacco constituents.
    (Comment) One comment suggested that FDA add ``to the best of your
knowledge'' at the beginning of questions 6 through 10.
    (Response) FDA does not believe this is necessary as these
questions include a ``don't know'' response option. Further, these
questions were used in previous research (Ref. 1).
    (Comment) There were a few comments about the ``understanding''
section of the survey. One comment suggested that FDA add nicotine,
acetone, and carbon monoxide to this section. Another comment suggested
that FDA expand the ``Understanding'' section to include a section on
addiction. The comment suggested that the section list specific
constituents and ask participants if they cause addiction. One comment
suggested that FDA modify the question that asks, ``does smoking cause
addiction'' and change it to ``does smoking cigarettes cause
addiction.''
    (Response) FDA appreciates these suggestions. FDA declines to add
additional items or modify items in the ``understanding'' section as it
is consistent with prior research. Further, these items were part of
cognitive testing and did not cause confusion. Prior research
deliberately selected two chemicals that would be familiar to
respondents (ammonia and lead) and three that would be unfamiliar (1-
aminonaphthalene, acrylonitrile, and isoprene) (Ref. 1). Further, even
though there is not a specific question about the link between certain
chemicals and addiction, FDA assesses participants' understanding of
whether smoking causes addiction in items 11 to 24.
    (Comment) There were two comments that asked FDA to add additional
items measuring participants behavior. One comment suggested that FDA
should add additional questions so that the survey could also determine
how likely someone is to not only switch brands, but also whether they
are likely to quit or switch to a different product. Another comment
suggested that FDA add questions to the post-test to measure the
behavioral impacts of these formats including cessation intentions.
    (Response) Although measuring these behavioral intentions and
outcomes are interesting, these questions are outside the scope of this
study. The focus of this study is to assess whether displays of HPHC
information are understandable and not misleading per the statutory
requirement.
    (Comment) FDA received two comments that supported the collection
of this information. One comment urged FDA to move forward promptly
with this study.
    (Response) FDA appreciates this comment and intend to move forward
with the study promptly. We note that data collection will occur within
2 months following OMB approval.
    (Comment) One comment noted that FDA was required to publish a list
of constituents in a format that is understandable and not misleading
to a lay person by June 2012. However, no such list has been published.
The comment also noted that it is important for FDA to ensure that
information is disclosed in a way that is not misleading.
    (Response) FDA agrees that the proposed study is important to help
FDA fulfill its statutory requirement. FDA has undertaken an extensive
program of research to ensure that we not only publish a list of
constituents in a manner that is understandable and not misleading, but
also avoid any unintended consequences of such a list.
    (Comment) One comment noted that FDA should make it clear that
characterizations of information on the list by tobacco product
manufacturers in advertising or promotional material are subject to the
requirements of the

provisions of section 911 of the Tobacco Control Act (21 U.S.C. 387k)
regarding modified risk claims.
    (Response) Thank you for this suggestion. However, this comment is
outside the scope of the present study as it is about the
implementation of the public displays of HPHCs and not about testing
the display.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
       Type of respondent            Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Youth Screener..................           1,800               1           1,800            0.05              90
Youth Survey....................           1,500               1           1,500            0.33             500
                                 -------------------------------------------------------------------------------
    Total Youth Hours...........  ..............  ..............  ..............  ..............             590
----------------------------------------------------------------------------------------------------------------
Adult Screener..................           3,400               1           3,400            0.05             170
Adult Survey....................           3,000               1           3,000            0.33           1,000
                                 -------------------------------------------------------------------------------
    Total Adult Hours...........  ..............  ..............  ..............  ..............           1,170
                                 -------------------------------------------------------------------------------
    Total Burden Hours..........  ..............  ..............  ..............  ..............           1,760
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    For this study, potential participants will be recruited by a
market research firm that maintains an internet panel, and information
will be collected through self-administered, online screening tests and
surveys of youth aged 13 to17 and adults aged 18 and older.
Approximately 5,200 respondents (1,800 youth and 3,400 adults) will be
requested to complete a screening test to determine eligibility for
participation in the study, estimated to take approximately 3 minutes
(0.05 hour) per screening test, for a total of 260 hours for screening
activities. Respondents who qualify for the study will be directed to
the survey. Approximately 4,500 participants (1,500 youth and 3,000
adults) will complete the survey, estimated to take 20 minutes (0.33
hour) per survey, for a total of 1,500 hours for completion of both
adult and adolescent samples. The length of time to complete the
screening test and survey are based on the research firm's experience
that panel members answer approximately 2.5 questions per minute. This
data collection will take place one time in 2019. Thus, the total
estimated burden is estimated to be 1,760 hours.

II. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 and
are available for viewing by interested persons between 9 a.m. and 4
p.m., Monday through Friday; they also are available electronically at
https://www.regulations.gov. References without asterisks are not on
public display at https://www.regulations.gov because they have
copyright restriction. Some may be available at the website address, if
listed. References without asterisks are available for viewing only at
the Dockets Management Staff.

    1. Byron, M.J., A.J. Lazard, E. Peters, et al. (2018).
``Effective Formats for Communicating Risks from Cigarette Smoke
Chemicals.'' Tobacco Regulatory Science, 4(2), 16-29. doi:10.18001/
TRS.4.2.2.
    * 2. O'Brien, E.K., A. Persoskie, and J. Tam (2019). ``Multi-
Item Measures of Tobacco Health Perceptions: A Review,'' American
Journal of Health Behavior, 43(2), 266-278. doi:10.5993/AJHB.43.2.4.
    3. Brewer, N.T., J.C. Morgan, S.A, Baig, et al. (2017). ``Public
Understanding of Cigarette Smoke Constituents: Three US Surveys.''
Tobacco Control, 26(5), 592-599.
    * 4. Nadler, J.T., R. Weston, and E.C. Voyles (2015). ``Stuck in
the Middle: The Use and Interpretation of Mid-Points in Items on
Questionnaires,'' The Journal of General Psychology, 142(2), 71-89.

    Dated: June 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13758 Filed 6-26-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 141 (Friday, July 22, 2011)]
[Notices]
[Pages 44012-44013]
[FR Doc No: 2011-18473]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2010-P-0577 and FDA-2010-P-0579]

Determination That NUVIGIL (Armodafinil) Tablets, 100 Milligrams
and 200 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety
or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that
NUVIGIL (armodafinil) Tablets, 100 milligrams (mg) and 200 mg, were not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for armodafinil tablets, 100 mg and 200 mg, if all
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Molly Flannery, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6237, Silver Spring, MD 20993-0002, 301-
796-3543.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA). The only clinical data
required in an ANDA are data to show that the drug that is the subject
of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does
not refer to a listed drug.
    NUVIGIL (armodafinil) Tablets, 100 mg and 200 mg, are the subject
of NDA 21-875, held by Cephalon, Inc., and initially approved on June
15, 2007. NUVIGIL is indicated to improve wakefulness in patients with
excessive sleepiness associated with obstructive sleep apnea,
narcolepsy, and shift work disorder.
    NUVIGIL (armodafinil) Tablets, 100 mg and 200 mg, are currently
listed in the ``Discontinued Drug Product List'' section of the Orange
Book.
    Actavis, Inc., submitted a citizen petition dated November 9, 2010
(Docket No. FDA-2010-P-0579), under 21 CFR 10.30, requesting that the
Agency determine that NUVIGIL (armodafinil) Tablets, 100 mg and 200 mg,
were not voluntarily withdrawn for safety or efficacy reasons. Watson
Laboratories, Inc., also submitted a

citizen petition dated November 9, 2010 (Docket No. FDA-2010-P-0577),
under 21 CFR 10.30, requesting that the Agency determine whether
NUVIGIL (armodafinil) Tablets, 100 mg and 200 mg, were withdrawn from
sale for reasons of safety or effectiveness.
    After considering the citizen petitions and reviewing Agency
records, FDA has determined under 314.161 that NUVIGIL (armodafinil)
Tablets, 100 mg and 200 mg, were not withdrawn for reasons of safety or
effectiveness. The petitioners have identified no data or other
information suggesting that NUVIGIL (armodafinil) Tablets, 100 mg and
200 mg, were withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
NUVIGIL (armodafinil) Tablets, 100 mg and 200 mg, from sale. We have
also independently evaluated relevant literature and data for possible
postmarketing adverse events. We have found no information that would
indicate that this product was withdrawn from sale for reasons of
safety or effectiveness.
    Accordingly, the Agency will continue to list NUVIGIL (armodafinil)
Tablets, 100 mg and 200 mg, in the ``Discontinued Drug Product List''
section of the Orange Book. The ``Discontinued Drug Product List''
delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to NUVIGIL (armodafinil) Tablets, 100
mg and 200 mg, may be approved by the Agency as long as they meet all
other legal and regulatory requirements for the approval of ANDAs. If
FDA determines that labeling for this drug product should be revised to
meet current standards, the Agency will advise ANDA applicants to
submit such labeling.

    Dated: July 18 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-18473 Filed 7-21-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: November 28, 2008 (Volume 73, Number 230)]
[Notices]
[Page 72476]
[DOCID:fr28no08-68]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR09-5-000]

Lee 8 Storage Partnership; Notice of Petition for Rate Approval

November 21, 2008.
    Take notice that on November 14, 2008, Lee 8 Storage Partnership
(Lee 8) filed pursuant to section 284.123(b)(2) of the Commission's
regulations, filed a petition requesting that the Commission approve
its rates pursuant to section 31(a)(2) of the Natural Gas Policy Act of
1978. Lee 8 proposes system-wide maximum rates of $3.2988 per Dt of
deliverability and $0.0330 per Dt of capacity. In addition, Lee 8
states that it will charge 0.57% of the injected volumes and 0.57% of
the withdrawal volumes as an allowance for compressor fuel and lost-
and-unaccounted-for gas on Lee 8's system.
    Any person desiring to participate in this rate proceeding must
file a motion 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 on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time December 1, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-28291 Filed 11-26-08; 8:45 am]

BILLING CODE 6717-01-P