[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Notices]
[Pages 31323-31327]
[FR Doc No: 2021-12264]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0371]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Accelerated Approval Disclosures on Direct-to-Consumer
Prescription Drug Websites

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the proposed study entitled ``Accelerated
Approval Disclosures on Direct-to-Consumer Prescription Drug
websites.''

DATES: Submit either electronic or written comments on the collection
of information by August 10, 2021.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 10, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 10, 2021. 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.

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-2021-N-0371 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Accelerated Approval Disclosures
on Direct-to-Consumer Prescription Drug websites.'' 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, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>The questionnaire is available upon request from
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Accelerated Approval Disclosures on Direct-to-Consumer Prescription
Drug Websites

OMB Control Number 0910-NEW

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
    The Office of Prescription Drug Promotion's (OPDP) mission is to
protect the public health by helping to ensure that prescription drug
promotion is truthful, balanced, and accurately communicated. OPDP's
research program provides scientific evidence to help ensure that our
policies related to prescription drug promotion will have the greatest
benefit to public health.
    Toward that end, we have consistently conducted research to
evaluate the aspects of prescription drug promotion that are most
central to our mission, focusing in particular on three main topic
areas: Advertising features, including content and format; target
populations; and research quality. Through the evaluation of
advertising features, we assess how elements such as graphics, format,
and disease and product characteristics impact the

communication and understanding of prescription drug risks and
benefits. Focusing on target populations allows us to evaluate how
understanding of prescription drug risks and benefits may vary as a
function of audience, and our focus on research quality aims at
maximizing the quality of our research data through analytical
methodology development and investigation of sampling and response
issues. This study will inform the first topic area, advertising
features, including content and format; and the second topic area,
target populations.
    Because we recognize the strength of data and the confidence in the
robust nature of the findings is improved through the results of
multiple converging studies, we continue to develop evidence to inform
our thinking. We evaluate the results from our studies within the
broader context of research and findings from other sources, and this
larger body of knowledge collectively informs our policies as well as
our research program. Our research is documented on our homepage, which
can be found at: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research. The
website includes links to the latest Federal Register notices and peer-
reviewed publications produced by our office. The website maintains
information on studies we have conducted, dating back to a direct-to-
consumer (DTC) survey conducted in 1999.

Background

    Pursuant to section 506(c) of the FD&C Act (21 U.S.C. 356(c)) and
21 CFR part 314, subpart H (or 21 CFR part 601, subpart E for
biological products), FDA may grant accelerated approval to a drug
product under section 505(c) of the FD&C Act or a biological product
under section 351(a) of the Public Health Service Act (42 U.S.C.
262(a)). This pathway enables faster approval of prescription drugs
intended to treat serious or life-threatening illnesses. Accelerated
approval may be based on a determination that a drug product has an
effect on a surrogate endpoint (for example, a blood test result) that
is reasonably likely to predict clinical benefit, or on a clinical
endpoint that can be measured earlier than irreversible morbidity or
mortality, that is reasonably likely to predict an effect on
irreversible morbidity or mortality or other clinical benefit (i.e., an
intermediate clinical endpoint). In approving a drug under the
accelerated approval pathway, the severity, rarity, or prevalence of a
condition, and the availability or lack of alternative treatments, are
taken into account.
    The accelerated approval pathway is limited to certain products
intended to treat serious or life-threatening illnesses as there can be
``[u]ncertainty about whether clinical benefit will be verified and the
possibility of undiscovered risks'' (FDA 2014 guidance for industry
entitled ``Expedited Programs for Serious Conditions--Drugs and
Biologics,'' available at https://www.fda.gov/downloads/Drugs/Guidances/UCM358301.pdf). Sponsors are generally required to conduct
post approval studies to verify and describe the predicted clinical
benefit, but those confirmatory studies are not complete at the time
that the accelerated approval is granted (Ref. 1). In the event that
the required post-approval confirmatory studies fail to verify and
describe the predicted effect or clinical benefit, a drug's approval
can be withdrawn using expedited procedures.
    Under FDA regulations governing physician labeling for prescription
drugs, the INDICATIONS AND USAGE section of FDA-approved prescribing
information for a drug approved under accelerated approval must include
not only the indication (21 CFR 201.57(c)) but also a ``succinct
description of the limitations of usefulness of the drug and any
uncertainty about anticipated clinical benefits . . .'' (21 CFR
201.57(c)(2)(i)(B)). In a guidance, FDA recommended that in addition to
these required elements, the INDICATIONS AND USAGE section for drugs
approved under accelerated approval should generally acknowledge that
continued approval for the drug or indication may be contingent on
verification and description of clinical benefit in confirmatory trials
(FDA 2019 guidance for industry entitled ``Labeling for Human
Prescription Drug and Biological Products Approved Under the
Accelerated Approval Pathway,'' available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM390058.pdf).
    Some DTC websites have included disclosures about accelerated
approval, and of those, many included similar content to that seen in
the INDICATIONS AND USAGE section of approved labeling. A content
analysis of DTC websites for accelerated approval products found that
21 percent of the disclosures used language directly from the approved
physician labeling, 79 percent of the disclosures used at least some
medical language, but 27 percent of the websites did not include any
disclosure that the products attained approval through this pathway
(Ref. 2). The same analysis found that 84 percent of accelerated
approval disclosures on DTC websites mentioned the approval basis, 68
percent mentioned unknown outcomes, and 47 percent mentioned
confirmatory trials (Ref. 2).
    OPDP recently conducted a general-population study testing the
disclosure of FDA accelerated approval information on a DTC
prescription drug website (OMB control number 0910-0872--Experimental
Study of an Accelerated Approval Disclosure). The study tested a
control condition with no disclosure; a disclosure based on wording
used in physician labeling, including more complex or technical
terminology (physician-labeling disclosure); and a consumer-friendly
disclosure drafted using simpler language intended to be suited for
that audience (consumer-friendly disclosure). The disclosures had three
elements: (1) Approval basis, (2) unknown outcomes, and (3)
confirmatory trials. The physician labeling disclosure was ``This
indication is based on response rate. An improvement in survival or
disease-related symptoms has not been established. Continued approval
for this indication may be contingent upon verification of clinical
benefit in subsequent trials.'' The consumer-friendly disclosure was
``In a clinical trial, [Drug X] returned blood counts to normal.
However, we currently do not know if [Drug X] helps people live longer
or feel better. We continue to study [Drug X] in clinical trials to
learn more about [Drug X]'s benefits.'' We also varied whether the
physician-labeling and consumer-friendly disclosures were presented
with low or high prominence (varying the size, color, and location of
the disclosure). Preliminary results related to the comprehension of
the disclosures tested in that study suggest that the consumer-friendly
disclosure helped participants understand information related to the
drug's accelerated approval, but that participants' understanding was
low overall.

New Proposed Study

    The purpose of the current project is to replicate and extend our
prior research through two studies by: (1) Testing the same
experimental conditions with a different study population (cancer
survivors and cancer caregivers in study 1) and (2) testing additional
consumer-friendly disclosures in study 2. Replication is an important
part of science and, if confirmation of prior results is seen, can

increase confidence in the results from our first study.
    With regard to proposed Study 1, public comments for FDA's previous
accelerated approval disclosure study and other similar FDA studies
have suggested conducting studies with people who have been diagnosed
with the medical condition or who are caregivers to patients diagnosed
with the medical condition that the fictitious drug in the study is
intended to treat. Specifically, public comments on the previous study
suggested enrolling participants who have been diagnosed with cancer
(i.e., cancer survivors) or people who have cared for loved ones with
cancer (i.e., cancer caregivers). Because a number of oncology products
are granted accelerated approval, cancer survivors and cancer
caregivers are more likely to seek out or be exposed to promotion for
accelerated approval products than the general population. They may
also be more familiar with cancer-related terms and concepts than the
general population. Study 1 will involve cancer survivors and cancer
caregivers, a different population than our prior study. It will test
the ``three element'' version of the disclosure as noted above. We will
also test the prominence of the disclosure (see table 1).
    With regard to study 2, public comments on the original study
(Docket No. FDA-2018-N-3138) expressed concern that over-disclosure
could dissuade consumers from considering accelerated approval
products. One public comment specifically suggested removing the
``unknown outcomes'' element in the consumer-friendly and physician-
labeling disclosures. Based on these comments, in study 2, we propose
testing four versions of the consumer-friendly disclosure (table 2):
The ``three element'' version of the consumer-friendly disclosure as
well as three other consumer-friendly disclosures that vary with
respect to which of these three elements they address. This will allow
us to evaluate the impact on participants' comprehension of the
disclosure and perception of the fictitious drug when they view a
disclosure with only the approval basis, the approval basis plus
information about the unknown outcomes, the approval basis plus
information about confirmatory trials, and finally the approval basis
plus information about both the unknown outcomes and confirmatory
trials. In study 2, the prominence of all the test conditions will be
the same and will be the same as the ``high prominence'' version tested
in study 1.
    We plan to conduct two pretests not longer than 20 minutes,
administered via internet panel, to pilot the main study procedures. We
then plan to conduct two main studies not longer than 20 minutes,
administered via internet panel. For the pretests and main studies, we
will randomly assign the participants to one of the test conditions
(see table 1 for the study 1 design and table 2 for the study 2
design). In both studies, participants will view a website for a
fictitious oncology prescription drug. After viewing the website,
participants will complete a questionnaire that assesses whether
participants noticed the disclosure and their understanding of it, as
well as perceptions of the drug's risks and benefits. We will also
measure covariates such as demographics and literacy. The questionnaire
is available upon request from [email protected]
    For study 1, we hypothesize that participants will be more likely
to notice the disclosure when it is presented more, rather than less,
prominently. In turn, we expect that participants' perceptions of the
drug are more likely to be affected by the disclosure in the high
prominence condition. We also hypothesize that participants will be
more likely to notice and understand the disclosure and use it to form
their perceptions of the drug if they view the consumer-friendly
language. For study 2, we hypothesize that participants will be more
likely to understand each accelerated approval concept (i.e.,
confirmatory trials, unknown outcomes) when the disclosure directly
addresses the concept, compared with when the disclosure does not
directly address the concept. Finally, we will explore whether the
inclusion of the concepts of confirmatory trials and unknown outcomes
in the disclosure affects participants' perceived risk, perceived risk-
benefit tradeoff, perceptions of the website, or information-seeking
intentions. To test these hypotheses, we will conduct inferential
statistical tests such as logistic regression and analysis of variance.
    For the pretests and main studies, we plan to recruit individuals
who report a diagnosis with any cancer (except for certain non-melanoma
skin cancers) for half the sample and individuals who report being a
caregiver for someone with a diagnosis with any cancer (except for
certain non-melanoma skin cancers) for the other half of the sample. We
will exclude individuals who work for the U.S. Department of Health and
Human Services or work in the health care, marketing, advertising, or
pharmaceutical industries. With the sample sizes described below, we
will have sufficient power to detect small-sized effects in the main
study (table 3).

                                             Table 1--Study 1 Design
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                                          High prominence          Low prominence                Absent
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Physician-labeling version..........  Condition 1............  Condition 3...........  Condition 5.
Consumer-friendly version...........  Condition 2............  Condition 4...........
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                                             Table 2--Study 2 Design
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                                                       Consumer-friendly disclosure elements
                                 -------------------------------------------------------------------------------
                                                                                Approval basis +
                                                       Approval basis +    Approval basis +   unknown outcomes +
                                    Approval basis     unknown outcomes      confirmatory        confirmatory
                                                                                trials              trials
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High prominence.................  Condition 6.......  Condition 7.......  Condition 8.......  Study 1 Condition
                                                                                2.
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    FDA estimates the burden of this collection of information as
follows:

                                                     Table 3--Estimated Annual Reporting Burden \1\
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                                                                 Number of
                  Activity                       Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
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Pretest 1 and 2 screener....................           3,600               1               1  0.08 (5 minutes)..........................             288
Study 1 and 2 screener......................          20,600               1               1  0.08 (5 minutes)..........................           1,648
Pretest 1...................................             100               1               1  0.33 (20 minutes).........................              33
Main Study 1................................             630               1               1  0.33 (20 minutes).........................             208
Pretest 2...................................              80               1               1  .33 (20 minutes)..........................              26
Main Study 2................................             400               1               1  0.33 (20 minutes).........................             132
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................           2,335
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES), 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. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

1. Beaver J.A., L.J. Howie L.J., L. Pelosof L, et al. ``A 25-Year
Experience of U.S. Food and Drug Administration Accelerated Approval
of Malignant Hematology and Oncology Drugs and Biologics: A
Review.'' JAMA Oncology. 2018; 4(6):849-856. doi:10.1001/
jamaoncol.2017.5618
2. Sullivan H.W., A.C. O'Donoghue, K.T. David, N.J. Patel.
``Disclosing Accelerated Approval on Direct-to-Consumer Prescription
Drug Websites.'' Pharmacoepidemiology and Drug Safety. 2018;27:1277-
1280. https://doi.org/10.1002/pds.4664

    Dated: June 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12264 Filed 6-10-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 35 (Tuesday, February 23, 2016)]
[Notices]
[Page 9038]
[FR Doc No: 2016-03739]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77170; SR-NYSEArca-2015-104]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Withdrawal of a Proposed Rule Change To Adopt a New Policy Relating To
Trade Reports for Exchange Traded Products

February 18, 2016.
    On October 28, 2015, NYSE Arca, Inc. (``Exchange'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to adopt a new
policy relating to the Exchange's treatment of trade reports for
Exchange Traded Products that it determines to be inconsistent with the
prevailing market. The proposed rule change was published for comment
in the Federal Register on November 18, 2015.\3\ The Commission
received two comments on the proposed rule change.\4\ On December 17,
2015, pursuant to section 19(b)(2) of the Act,\5\ the Commission
designated a longer period within which to either approve the proposed
rule change, disapprove the proposed rule change, or institute
proceedings to determine whether to disapprove the proposed rule
change.\6\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 76431 (Nov. 12,
2015), 80 FR 72126.
    \4\ See Letter from Gary Gastineau, ETF Consultants.com, Inc.,
to the Commission (Nov. 27, 2015); Letter from James J. Angel,
Associate Professor, Georgetown University, to the Commission (Dec.
5, 2015). All comments on the proposed rule change are available on
the Commission's Web site at: http://www.sec.gov/comments/sr-nysearca-2015-104/nysearca2015104.shtml.
    \5\ 15 U.S.C. 78s(b)(2).
    \6\ See Securities Exchange Act Release No. 76673, 80 FR 79963
(Dec. 23, 2015). The Commission determined that it was appropriate
to designate a longer period within which to take action on the
proposed rule change so that it had sufficient time to consider the
proposed rule change and the comments received. Accordingly, the
Commission designated February 16, 2016 as the date by which it
should approve, disapprove, or institute proceedings to determine
whether to disapprove the proposed rule change.
---------------------------------------------------------------------------

    On January 28, 2016, the Exchange withdrew the proposed rule change
(SR-NYSEArca-2015-104).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(57).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-03739 Filed 2-22-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 116 (Friday, June 15, 2012)]
[Rules and Regulations]
[Pages 35866-35870]
[FR Doc No: 2012-14595]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2010-0969; FRL-9686-9]

Approval and Promulgation of Implementation Plans; Revisions to
the Georgia State Implementation Plan

AGENCY: Environmental Protection Agency.

ACTION: Direct final rule.

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SUMMARY: EPA is taking direct final action to approve a State
Implementation Plan (SIP) revision submitted by the State of Georgia,
through the Department of Natural Resources (GA DNR), on November 16,
2010. This revision consists of transportation conformity criteria and
procedures related to interagency consultation and enforceability of
certain transportation-related control measures and mitigation
measures. The intended effect is to update the transportation
conformity criteria and procedures in the Georgia SIP. This action is
being taken pursuant to section 110 of the Clean Air Act.

DATES: This direct final rule is effective August 14, 2012 without
further notice, unless EPA receives adverse comment by July 16, 2012.
If EPA receives such comments, it will publish a timely withdrawal of
the direct final rule in the Federal Register and inform the public
that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2010-0969, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2010-0969,'' Air Quality Modeling and
Transportation Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW., Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier: Amanetta Somerville, Air Quality
Modeling and Transportation Section, Air Planning Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. Such deliveries are only accepted during the Regional
Office's normal hours of operation. The Regional Office's official
hours of business are Monday through Friday, 8:30 to 4:30, excluding
federal holidays.
    Instructions: Direct your comments to Docket ID No. ``EPA-R04-OAR-
2010-0969.'' 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 through
www.regulations.gov or email, information that you consider to be CBI
or otherwise protected. 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. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    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 at the Air Quality Modeling and Transportation Section,
Air Planning Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 to 4:30, excluding
federal holidays.

FOR FURTHER INFORMATION CONTACT: Amanetta Somerville, Air Quality
Modeling and Transportation Section, Air Planning Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. Ms. Somerville's telephone number is<PHONE_NUMBER>. She can
also be reached via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Transportation Conformity
II. Background for This Action
    A. Federal Requirements
    B. Atlanta Conformity SIP
    C. Chattanooga Conformity SIP
    D. Macon Conformity SIP
    E. Rome Conformity SIP
III. State Submittal and EPA Evaluation
IV. Public Comment and Final Action
V. Statutory and Executive Order Reviews

I. Transportation Conformity

    Transportation conformity (hereafter referred to as ``conformity'')
is required under section 176(c) of the Clean Air Act (CAA or Act) to
ensure that federally supported highway, transit projects, and other
activities are consistent with (``conform to'') the purpose of the SIP.
Conformity currently applies to areas that are designated
nonattainment, and to areas that have been redesignated to attainment
after 1990 (maintenance areas) with plans developed under section 175A
of the Act, for the following transportation related criteria
pollutants: Ozone, particulate matter (e.g., PM2.5 and
PM10), carbon monoxide, and nitrogen dioxide.
    Conformity to the purpose of the SIP means that transportation
activities will not cause new air quality violations, worsen existing
violations, or delay timely attainment of the relevant criteria
pollutants, also known as national ambient air quality standards
(NAAQS). The transportation conformity regulation is found in 40 CFR
part 93 and provisions related to conformity SIPs are found in 40 CFR
51.390.

II. Background for This Action

A. Federal Requirements

    EPA promulgated the Federal transportation conformity criteria and
procedures (``Conformity Rule'') on November 24, 1993 (58 FR 62188).
Among other things, the rule required states to address all provisions
of the conformity rule in their SIPs frequently referred to as
``conformity SIPs.'' Under 40 CFR 51.390, most sections of the
conformity rule were required to be copied verbatim. States were also
required to tailor all or portions of the following three sections of
the conformity rule to meet their state's individual circumstances: 40
CFR 93.105, which addresses consultation procedures; 40 CFR
93.122(a)(4)(ii), which addresses written commitments to control
measures that are not included in a metropolitan planning
organization's (MPO's) transportation plan and transportation
improvement program that must be obtained prior to a conformity
determination, and the requirement that such commitments, when they
exist, must be fulfilled; and 40 CFR 93.125(c), which addresses written
commitments to mitigation measures that must be obtained prior to a
project-level conformity determination, and the requirement that
project sponsors must comply with such commitments, when they exist.
    On August 10, 2005, the ``Safe, Accountable, Flexible, Efficient
Transportation Equity Act: A Legacy for Users'' (SAFETEA-LU) was signed
into law. SAFETEA-LU revised section 176(c) of the CAA transportation
conformity provisions. One of the changes streamlines the requirements
for conformity SIPs. Under SAFETEA-LU, states are required to address
and tailor only three sections of the rule in their conformity SIPs: 40
CFR 93.105, 40 CFR 93.122(a)(4)(ii), and, 40 CFR 93.125(c), described
above. In general, states are no longer required to submit conformity
SIP revisions that address the other sections of the conformity rule.
These changes took effect on August 10, 2005, when SAFETEA-LU was
signed into law.

B. Atlanta Conformity SIP

    Effective June 15, 2004, EPA designated 20 whole counties in the
Atlanta area, as nonattainment for the 1997 8-hour ozone standard. The
counties include Barrow, Bartow, Carroll, Cherokee, Clayton, Cobb,
Coweta, DeKalb, Douglas, Fayette, Forsyth, Fulton, Gwinnett, Hall,
Henry, Newton, Paulding, Rockdale, Spalding, and Walton counties.
Effective April 5, 2005, EPA designated 20 whole counties, and a
portion of two counties in the Atlanta area, as nonattainment for the
1997 Annual PM2.5 standard. The whole counties include
Barrow, Bartow, Carroll, Cherokee, Clayton, Cobb, Coweta, DeKalb,
Douglas, Fayette, Forysth, Fulton, Gwinnett, Hall, Henry, Newton,
Paulding, Rockdale, Spalding, and Walton counties; the partial counties
include Heard and Putnam counties. The current designation status of
both the Atlanta 1997 8-hour ozone and 1997 Annual PM2.5
areas is nonattainment.
    There are two MPOs that are responsible for transportation planning
for areas within the Atlanta nonattainment areas. The Atlanta Regional
Commission (ARC) is the MPO for most of the Atlanta 1997 8-hour ozone
and 1997 Annual PM2.5 nonattainment areas. ARC's planning
boundary includes the whole counties of Cherokee, Clayton, Cobb,
Coweta, DeKalb, Douglas, Fayette, Forsyth, Fulton, Gwinnett, Henry,
Paulding and Rockdale counties; and portions of Barrow, Bartow, Newton,
Spalding and Walton counties in the Atlanta, Georgia area. Gainesville-
Hall MPO (GHMPO) is the other MPO for the Atlanta 1997 8-hour ozone and
1997 Annual PM2.5 nonattainment areas. GHMPO's planning
boundary includes Hall County. Walton County and the portions of
Barrow, Bartow, Heard, Newton, Putnam, Spalding counties are considered
``donut'' \1\ areas for the purposes of implementing transportation
conformity in this area. Per the Transportation Conformity Rule, the
MPO's conformity determination is not complete without a regional
analysis that considers the projects in the MPO area(s) as well as the
donut areas that are within the nonattainment/maintenance area. For the
purposes of implementing 1997 8-hour ozone and 1997 Annual
PM2.5 conformity, ARC serves as the lead agency for the
preparation, consultation, and distribution of the conformity
determinations.
---------------------------------------------------------------------------

    \1\ Donut areas are geographic areas outside a metropolitan
planning area boundary, but inside the boundary of a nonattainment
or maintenance area that contains any part of a metropolitan area.
---------------------------------------------------------------------------

    Previously Georgia had established transportation conformity SIP
for the Atlanta area. On September 27, 2002, EPA approved the Atlanta
area's SIP revision which incorporated by reference 40 CFR 93 Subpart
A, 67 FR 60869, and customized 40 CFR 93.105, 93.122(a)(4)(ii), and
93.125(c) for all of the MPOs in the entire state. Specifically, the
Atlanta area established a Memorandum of Agreement (MOA) for
implementing the conformity Criteria and Consultation Procedure. The
new conformity SIP (the subject of this rule making) has removed any
incorporation by reference and has converted the MOA to a State Rule to
be consistent with the SAFETEA-LU revisions to the CAA (Pub. L. 109-59)
and subsequent regulations published on January 24, 2008 (73 FR 4420).

C. Chattanooga Conformity SIP

    Effective April 5, 2005, EPA designated Hamilton County in
Tennessee, Walker and Catoosa Counties in Georgia, and a portion of
Jackson County, Alabama in the tri-state Chattanooga area, as
nonattainment for the 1997 Annual PM2.5 standard. The
current designation status of the Chattanooga 1997 Annual
PM2.5 area is nonattainment.
    The Chattanooga-Hamilton County, North Georgia Transportation
Planning Organization (CHNGTPO) is the MPO for most of the tri-state
Chattanooga, TN-GA, 1997 Annual PM2.5 area. CHCNGTPO's
planning boundary includes Portions of Walker and Catoosa Counties in
Georgia and Hamilton County in Tennessee; Portions of Walker and
Catoosa Counties in Georgia; and a portion of Jackson County, Alabama.
The portion of Jackson County, Alabama that is within the Chattanooga
1997 Annual PM2.5 area is not within the CHCNGTPO planning
boundary and thus is considered a ``donut'' area for the purposes of
implementing transportation conformity in this area. Per the
Transportation Conformity Rule, the MPO's conformity determination is
not complete without a regional analysis that considers the projects in
the MPO area as well as the donut areas that are within the
nonattainment/maintenance area. For the purposes of implementing 1997
Annual PM2.5 conformity, CHCNGTPO serves as the lead agency
for the preparation, consultation, and distribution of the conformity
determinations.
    Walker and Catoosa Counties in Georgia which are a part of the
Chattanooga area do not have a previous conformity SIP. The states of
Tennessee and Alabama will establish conformity procedures for the
counties that make up the Tennessee and Alabama portion of the
Chattanooga nonattainment area in their individual conformity SIPs. The
SIP revision at issue now includes the conformity procedures for Walker
and Catoosa Counties as part of the 1997 Annual PM2.5
Chattanooga nonattainment area.

D. Macon Conformity SIP

    Effective June 15, 2004, EPA designated Bibb County and a portion
of Monroe County in the Macon, Georgia area as nonattainment for the
1997 8-hour ozone standard. Effective April 5, 2005, EPA designated
Bibb County and a portion of Monroe County in the Macon, Georgia area
as nonattainment for the 1997 Annual PM2.5 standard. The
current designation status of the Macon 1997 8-hour ozone and 1997
Annual PM2.5 areas are nonattainment for PM2.5
and attainment (with a maintenance plan) for 1997 8-hour ozone (72 FR
53432, September 19, 2007).
    The Macon Area Transportation Study (MATS) is the MPO for most of
the Macon 1997 8-hour ozone and 1997 Annual PM2.5
nonattainment area. The MATS planning boundary includes all of Bibb
County. The portion of Monroe County that is included in the Macon 1997
8-hour ozone and 1997 Annual PM2.5 nonattainment areas is
not within the MATS planning boundary, and thus is considered a
``donut'' area for the purposes of implementing transportation
conformity in this area. The donut area of Monroe County entered into
an agreement with the Georgia Department of Transportation (DOT) that
will allow the Georgia DOT to represent them. Per the transportation
conformity regulations, the MPO's conformity determination is not
complete without a regional analysis that considers the transportation
projects in the MPO area as well as the donut areas that are within the
nonattainment area. For the purposes of implementing 1997 8-hour ozone
and 1997 Annual PM2.5 conformity, MATS serves as the lead
agency for the preparation, consultation and distribution of the
conformity determination.
    Bibb County and the portion of Monroe County, Georgia which are a
part of the Macon area do not have a previous conformity SIP. The SIP
revision at issue now includes the conformity procedures for both the
entire county of Bibb and the portion of Monroe County, Georgia, for
the Macon area.

E. Rome Conformity SIP

    Effective April 5, 2005, EPA designated a portion of Floyd County
in the Rome-Floyd area as nonattainment for the 1997 Annual
PM2.5 standard. The current designation status of the Rome-
Floyd County 1997 Annual PM2.5 area is nonattainment. The
Rome Floyd County MPO (RFCMPO) is the MPO for the entire Rome-Floyd
1997 Annual PM2.5 area. For the purposes of implementing
1997 Annual PM2.5 conformity, RFCMPO serves as the lead
agency for the preparation, consultation, and distribution of the
conformity determinations.
    Floyd County, Georgia which is a part of the Rome area does not
have a previous conformity SIP. The SIP revision at issue now includes
the conformity procedures for the entire county of Floyd county,
Georgia, for the Rome area.

III. State Submittal and EPA Evaluation

    On November 16, 2010, the State of Georgia, through GA DNR,
submitted the State's transportation conformity and consultation
interagency rule to EPA as a revision to the SIP. On February 21, 2011,
and again on March 10, 2011, GA DNR submitted supplemental information
regarding the Georgia transportation conformity rule. These three SIP
revisions established procedures for interagency consultation and
replaced the Memorandum of Agreement submitted by GA DNR and approved
by EPA on September 27, 2002 (67 FR 60869).
    The State of Georgia developed its consultation rule based on the
elements contained in 40 CFR 93.105, 93.122(a)(4)(ii), and 93.125(c).
As a first step, the State worked with the existing transportation
planning organization's interagency committee that included
representatives from the State air quality agency, State DOT, Federal
Highway Administration--Georgia Division, Federal Transit
Administration, the MPOs of the maintenance and nonattainment areas of
Georgia, and EPA. The interagency committee met regularly and drafted
the consultation rules considering elements in 40 CFR Part 93.105,
93.122(a)(4)(ii), and 93.125(c), and integrated the local procedures
and processes into the rule. The consultation process developed in this
rule is for the State of Georgia. On July 6, 2010, GA DNR held a public
hearing for the transportation conformity rulemaking.
    EPA has evaluated this SIP and has determined that the State has
met the requirements of Federal transportation conformity rule as
described in 40 CFR Part 51, Subpart T and 40 CFR Part 93, Subpart A.
GA DNR has satisfied the public participation and comprehensive
interagency consultation requirement during development and adoption of
the State Rule at the local level. Therefore, EPA is approving the rule
as a revision to the Georgia SIP. EPA's rule requires the states to
develop their own processes and procedures for interagency consultation
among the federal, state, and local agencies and resolution of
conflicts meeting the criteria in 40 CFR 93.105. The SIP revision must
include processes and procedures to be followed by the MPO, state DOT,
and U.S. DOT in consulting with the state and local air quality
agencies and EPA before making conformity determinations. The
transportation conformity SIP revision must also include processes and
procedures for the state and local air quality agencies and EPA to
coordinate the development of applicable SIPs with MPOs, state DOTs,
and U.S. DOT.
    EPA has reviewed the submittal to assure consistency with the CAA
as amended by SAFETEA-LU and EPA regulations (40 CFR part 93 and 40 CFR
51.390) governing state procedures for transportation conformity and
interagency consultation and has concluded that the submittal is
approvable. Details of EPA's review are set forth in a technical
support document (TSD), which has been included in the docket for this
action. Specifically, in the TSD, EPA identifies how the submitted
procedures satisfy our requirements under 40 CFR 93.105 for interagency
consultation with respect to the development of transportation plans
and programs, SIPs, and conformity determinations, the resolution of
conflicts, and the provision of adequate public consultation, and our
requirements under 40 CFR 93.122(a)(4)(ii) and 93.125(c) for
enforceability of control measures and mitigation measures.

IV. Public Comment and Final Action

    For the reasons set forth above, EPA is taking action under section
110 of the Act to approve the rule implementing the conformity criteria
and consultation procedures revision to the Georgia SIP pursuant to the
CAA, as a revision to the Georgia SIP. As a result of this action,
Georgia's previously SIP-approved conformity procedures for Georgia (67
FR 60869, September 27, 2002), will be replaced by the procedures
submitted to EPA on November 16, 2010, for approval and adopted by
State of Georgia on August 25, 2010. This action also establishes
consultation procedures for all counties in Georgia.
    EPA is publishing this rule without prior proposal because the
Agency views this as a noncontroversial submittal and anticipates no
adverse comments. However, in the proposed rules section of this
Federal Register publication, EPA is publishing a separate document
that will serve as the proposal to approve the SIP revision should
adverse comments be filed. This rule will be effective August 14, 2012
without further notice unless the

Agency receives adverse comments by July 16, 2012.
    If EPA receives such comments, then EPA will publish a document
withdrawing the final rule and informing the public that the rule will
not take effect. All public comments received will then be addressed in
a subsequent final rule based on the proposed rule. EPA will not
institute a second comment period. Parties interested in commenting
should do so at this time. If no such comments are received, the public
is advised that this rule will be effective on August 14, 2012 and no
further action will be taken on the proposed rule.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this 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 rule 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.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by August 14, 2012. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Incorporation
by reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

    Dated: June 1, 2012.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart L--Georgia

0
2. Section 52.570 is amended:
0
a. In paragraph (c) by adding a new entry in numerical order for ``391-
3-1-.15'';
0
b. In paragraph (e) by removing and reserving entry 12 to read as
follows:

Sec.  52.570  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Georgia Regulations
----------------------------------------------------------------------------------------------------------------
                                                    State effective
      State citation            Title/subject            date          EPA approval date        Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
391-3-1-.15...............  Georgia                         10/6/10  6/15/2012 [Insert     .....................
                             Transportation                           citation of
                             Conformity and                           publication].
                             Consultation
                             Interagency Rule.
----------------------------------------------------------------------------------------------------------------

* * * * *
    (e) * * *

                                 EPA-Approved Georgia Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                      Applicable geographic or   State submittal date/
 Name of nonregulatory SIP Provision     nonattainment area          effective date         EPA approval date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
12. [Reserved].                       ........................  .......................  .......................

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2012-14595 Filed 6-14-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: December 14, 2005 (Volume 70, Number 239)]
[Notices]
[Page 74062-74065]
[DOCID:fr14de05-107]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-52904; File No. SR-Amex-2005-092]

Self-Regulatory Organizations; American Stock Exchange LLC;
Notice of Filing and Order Granting Accelerated Approval of a Proposed
Rule Change and Amendment No. 1 Thereto Relating to the Trading
Pursuant to Unlisted Trading Privileges of the iShares S&P Global 100
Fund

December 7, 2005.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 13, 2005, the American Stock Exchange LLC (``Amex'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II and III below, which Items have been prepared by the
Exchange. On November 22, 2005, Amex filed Amendment No. 1 to the
proposed rule change.\3\ The Commission is publishing this notice to
solicit comments on the proposed rule change, as amended, from
interested persons and approving the proposal on an accelerated basis.
---------------------------------------------------------------------------

    \1\ 15 U.S.C 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ In Amendment No. 1, the Exchange clarified and supplemented
certain aspects of its proposal. Amendment No. 1 supplements the
information provided in various sections, as indicated, of the
Exchange's Form 19b-4.
---------------------------------------------------------------------------

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

    The Amex proposes to trade shares (the ``Fund Shares'' or
``Shares'') of the iShares S&P Global 100 Fund (ticker symbol: IOO)
(the ``Global 100 Fund'' or ``Fund'') pursuant to unlisted trading
privileges (``UTP'').
    The text of the proposed rule change is available on the Exchange's
Web site at (http://www.amex.com) at the principal office of the

Exchange, and at

the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to list and trade Fund Shares which are Index
Fund Shares under Amex Rules 1000A et seq., pursuant to UTP. The
Commission previously approved the original listing and trading of the
Fund Shares on the New York Stock Exchange, Inc. (``NYSE'').\4\ The
Fund is a separate series of the iShares Trust (the ``Trust'').
Standard & Poor's Corporation, a division of The McGraw-Hill Companies,
Inc. (``S&P''), calculates and maintains the S&P Global 100 Index (the
``Index'' or ``Underlying Index'') in cooperation with the NYSE. The
Underlying Index is governed and maintained by S&P through an Index
Committee drawn from professionals at S&P. Additional information about
the Funds is also available at http://www.ishares.com.

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

    \4\ See Securities Exchange Act Release No. 43658 (December 1,
2000), 65 FR 77408 (December 11, 2000) (SR-NYSE-00-53) (``NYSE
Order''). The Fund commenced trading on the NYSE on December 8,
2000.
---------------------------------------------------------------------------

    The investment objective of the Fund is to provide investment
results that correspond generally to the performance of the Underlying
Index. The Underlying Index seeks results that correspond generally to
the price and yield performance, before fees and expenses, of 100
multinational, blue chip companies of major importance in the global
equity markets as defined by the Index. The Index includes 100 large-
cap companies drawn from the S&P 1200 Index, whose businesses are
global in nature and derive a substantial portion of their operating
income, assets and employees from multiple countries.\5\ The Index
description, including any changes thereto, may be found on the S&P
Global Web site at http://www.spglobal.com.

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

    \5\ A global company is defined as a corporation that has
production facilities and/or other fixed assets in at least one
nation other than its home country and makes its major management
decisions in a global context. The degree to which sales are
executed outside the home country is a factor in determining a
company's global reach.
---------------------------------------------------------------------------

(a) Dissemination of Information About the Fund Shares

    Quotations for and last sale information regarding the Fund is
disseminated through the Consolidated Tape Association (``CTA''). The
net asset value (``NAV'') of the Fund is calculated each business day,
normally at the close of regular trading of the NYSE, and is published
in a number of places, including http://www.iShares.com and through the

facilities of CTA. According to the Funds' prospectus, Investors Bank &
Trust Company, the administrator, custodian and transfer agent for the
Fund, determines the NAV for the Funds as of the close of regular
trading on the NYSE (ordinarily 4 p.m., Eastern time) on each day that
the NYSE is open for trading.\6\ The Funds and the index calculation
methodology for the Index is both described in more detail in the NYSE
Order.
---------------------------------------------------------------------------

    \6\ The Web site for the Trust, http://www.iShares.com, makes

available a variety of other relevant information about the Shares.
---------------------------------------------------------------------------

    In order to provide updated information relating to the Funds for
use by investors, professionals, and persons wishing to create or
redeem Fund Shares in creation unit aggregation (``Creation Units''),
the NYSE disseminates, through the facilities of CTA, the indicative
optimized portfolio value (``IOPV''), calculated by Bloomberg, L.P.,
every fifteen (15) seconds during the trading hours for the Shares of
9:30 a.m. to 4:15 p.m. ET.
    As described in the Funds' prospectus, dividends are accrued daily
from net investment income and will be declared and paid to beneficial
owners of record at least annually by the Funds. The process for
payment of dividends and other distributions is described in more
detail in the Funds' Prospectus and in the NYSE Order.

(b) Trading Rules

    The Exchange deems the Fund Shares to be equity securities, thus
rendering trading in the Shares subject to the Exchange's existing
rules governing the trading of equity securities. The trading hours for
the Funds on the Exchange will be 9:30 a.m. to 4:15 p.m. Eastern Time
(``ET''). Shares trade with a minimum price variation of $0.01.
    Amex Rule 190 generally precludes certain business relationships
between an issuer and the specialist in the issuer's securities.
Exceptions in the rule permit specialists in Fund Shares to enter into
Creation Unit transactions to facilitate the maintenance of a fair and
orderly market. Commentary .04 to Amex Rule 190 specifically applies to
Index Fund Shares listed on the Exchange, including the Shares.
Commentary .04 states that nothing in Amex Rule 190(a) should be
construed to restrict a specialist registered in a security issued by
an investment company from purchasing and redeeming the listed
security, or securities that can be subdivided or converted into the
listed security, from the issuer as appropriate to facilitate the
maintenance of a fair and orderly market.
    Amex Rule 154, Commentary .04(c) provides that stop and stop limit
orders to buy or sell a security (other than an option, which is
covered by Rule 950(f) and Commentary thereto) the price of which is
derivatively priced based upon another security or index of securities,
may with the prior approval of a Floor Official, be elected by a
quotation, as set forth in Commentary .04(c)(i-v). The Exchange has
designated Index Fund Shares, including the Funds Shares, as eligible
for this treatment.
    The rules of the Exchange require its members to deliver a
prospectus or product description to investors purchasing Shares of the
Fund prior to or concurrently with the confirmation of a transaction in
such Shares. The Exchange notes, however, that although Exchange Rule
1000A provides for delivery of written descriptions to customers of
Funds that have received an exemption from section 24(d) of the
Investment Company Act of 1940 and the Trust has received such an
exemption, there is at this time no written description available for
these Funds. The Exchange will advise its members and member
organizations that delivery of a prospectus in lieu of a written
description would satisfy the requirements of Rule 1000A.
    The Amex will cease trading in the Fund Shares if (a) the primary
market stops trading the Fund Shares because of a regulatory halt akin
to a halt based on Amex Rule 117 and/or a halt because dissemination of
the indicative optimized portfolio value (``IOPV'') and/or underlying
index value has ceased or (b) the primary market delists the Fund
Shares.

(c) Surveillance

    The Exchange notes that the Underlying Index is broad-based and has
components with significant market

capitalizations and liquidity.\7\ Nevertheless, the Exchange represents
that its surveillance procedures are adequate to properly monitor the
trading of the Shares. Specifically, the Amex will rely on its existing
surveillance procedures governing Index Fund Shares, which have been
deemed adequate under the Act.
---------------------------------------------------------------------------

    \7\ Telephone conversation between Florence Harmon, Senior
Special Counsel, Division of Market Regulation, Commission, and
Jeffrey Burns, Associate General Counsel, Amex, on December 6, 2005.
---------------------------------------------------------------------------

(d) Information Circular

    In connection with the trading of the Shares, the Amex will inform
its members in an Information Circular of the special characteristics
and risks associated with trading of the Shares, such as, a description
of the Fund and associated Shares, how the Fund Shares are created and
redeemed in Creation Units (e.g., that Fund Shares are not individually
redeemable), foreign currency risks, foreign securities
characteristics, applicable foreign country laws and restrictions,
applicable Exchange rules, dissemination information, trading
information, the applicability of suitability rules and a discussion of
any relief provided by the Commission or the staff from any rules under
the Act. Additionally, in the Information Circular, the Exchange will
advise its members to deliver a prospectus to investors purchasing
Shares of the Fund prior to or concurrently with the confirmation of a
transaction in such Shares. The Information Circular will also discuss
the information that will be publicly available about the Shares.
    The Information Circular will also remind members of their
suitability obligations, including Amex Rule 411, which impose a duty
of the due diligence on its members and member firms to learn the
essential facts relating to every customer prior to trading the
Shares.\8\
---------------------------------------------------------------------------

    \8\ Telephone conversation between Florence Harmon, Senior
Special Counsel, Division of Market Regulation, Commission, and
Jeffrey Burns, Associate General Counsel, Amex, on December 6, 2005.
---------------------------------------------------------------------------

2. Statutory Basis
    The proposed rule change, as amended, is consistent with section
6(b) of the Act \9\ in general and furthers the objectives of section
6(b)(5) \10\ in particular in that it is designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transaction in
securities, and, in general to protect investors and the public
interest. In addition, the Exchange believes that the proposal is
consistent with Rule 12f-5 under the Act \11\ because it deems the Fund
Shares to be equity securities, thus rendering the Shares subject to
the Exchange's existing rules governing the trading of equity
securities.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b).
    \10\ 15 U.S.C. 78s(b)(5).
    \11\ 17 CFR 240.12f-5.
---------------------------------------------------------------------------

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

    The Exchange believes that the proposed rule change, as amended,
will impose no burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

III. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-Amex-2005-092 on the subject line.

Paper Comments

     Send paper comments in triplicate to Jonathan G. Katz,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-9303.
    All submissions should refer to File Number SR-Amex-2005-092. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the Amex. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make publicly available. All submissions should refer to
File Number SR-Amex-2005-092 and should be submitted on or before
January 4, 2006.

IV. Commission's Findings and Order Granting Accelerated Approval of
Proposed Rule Change

    The Commission finds that the proposed rule change, as amended, is
consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities
exchange.\12\ In particular, the Commission finds that the proposed
rule change is consistent with section 6(b)(5) of the Act,\13\ which
requires that an exchange have rules designed, among other things, to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and in general to protect investors and the public
interest.
---------------------------------------------------------------------------

    \12\ In approving this rule change, the Commission notes that it
has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \13\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    In addition, the Commission finds that the proposal is consistent
with section 12(f) of the Act,\14\ which permits an exchange to trade,
pursuant to UTP, a security that is listed and registered on another
exchange.\15\ The Commission notes that it previously approved the
listing and trading of the Shares on the NYSE.\16\ The Commission also
finds that the proposal is consistent with Rule

12f-5 under the Act,\17\ which provides that an exchange shall not
extend UTP to a security unless the exchange has in effect a rule or
rules providing for transactions in the class or type of security to
which the exchange extends UTP. Amex rules deem the Shares to be equity
securities, thus trading in the Shares will be subject to the
Exchange's existing rules governing the trading of equity
securities.\18\
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78l(f).
    \15\ Section 12(a) of the Act, 15 U.S.C. 78l(a), generally
prohibits a broker-dealer from trading a security on a national
securities exchange unless the security is registered on that
exchange pursuant to section 12 of the Act. Section 12(f) of the Act
excludes from this restriction trading in any security to which an
exchange ``extends UTP.'' When an exchange extends UTP to a
security, it allows its members to trade the security as if it were
listed and registered on the exchange even though it is not so
listed and registered.
    \16\ See NYSE Order, supra note 4.
    \17\ 17 CFR 240.12f-5.
    \18\ The Commission notes that Commentary .04 to existing Amex
Rule 190 will permit a specialist in the Shares to create or redeem
creation units of these funds to facilitate the maintenance of a
fair and orderly market. The Commission previously has found
Commentary .04 to Amex Rule 190 to be consistent with the Act. See
Securities Exchange Act Release No. 36947 (March 8, 1996), 61 FR
10606, 10612 (March 14, 1996) (SR-Amex-95-43).
---------------------------------------------------------------------------

    The Commission further believes that the proposal is consistent
with Section 11A(a)(1)(C)(iii) of the Act,\19\ which sets forth
Congress's finding that it is in the public interest and appropriate
for the protection of investors and the maintenance of fair and orderly
markets to assure the availability to brokers, dealers, and investors
of information with respect to quotations for and transactions in
securities. Quotations for and last sale information regarding the
Shares are disseminated through the Consolidated Quotation System.
Furthermore, the NYSE disseminates through the facilities of CTA an
updated IOPV for the Shares at least every 15 seconds from 9:30 a.m. to
4:15 p.m. E.T.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
---------------------------------------------------------------------------

    The Exchange will cease trading in the Shares if (a) the primary
market stops trading the Shares because of a regulatory halt similar to
a halt based on Amex Rule 117 and/or a halt because dissemination of
the IOPV and/or underlying index value has ceased or (b) the primary
market delists the Shares.
    In support of this proposed rule change, the Exchange has made the
following representations:
    1. Amex has appropriate rules to facilitate transactions in this
type of security.
    2. Amex surveillance procedures are adequate to properly monitor
the trading of the Shares on the Exchange.
    3. Amex will distribute an Information Circular to its members
prior to the commencement of trading of the Shares on the Exchange that
explains the terms, characteristics, and risks of trading such shares.
    4. Amex will require a member with a customer that purchases the
Shares on the Exchange to provide that customer with a product
prospectus and will note this prospectus delivery requirement in the
Information Circular.
    5. Amex will cease trading in the Shares if (a) the primary market
stops trading the Shares because of a regulatory halt similar to a halt
based on Amex Rule 117 and/or a halt because dissemination of the IOPV
and/or underlying index value has ceased or (b) the primary market
delists the Shares.
    This approval order is conditioned on Amex's adherence to these
representations.
    The Commission finds good cause for approving this proposed rule
change, as amended, before the thirtieth day after the publication of
notice thereof in the Federal Register. As noted previously, the
Commission previously found that the listing and trading of these
Shares on the NYSE is consistent with the Act.\20\ The Commission
presently is not aware of any issue that would cause it to revisit that
earlier finding or preclude the trading of these funds on the Exchange
pursuant to UTP. Therefore, accelerating approval of this proposed rule
change should benefit investors by creating, without undue delay,
additional competition in the market for these Shares.
---------------------------------------------------------------------------

    \20\ See NYSE Order, supra note 4.
---------------------------------------------------------------------------

V. Conclusion

    It Is therefore ordered, pursuant to section 19(b)(2) of the Act,
that the proposed rule change (SR-Amex-2005-092), is hereby approved on
an accelerated basis.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\21\
---------------------------------------------------------------------------

    \21\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jonathan G. Katz,
Secretary.
 [FR Doc. E5-7296 Filed 12-13-05; 8:45 am]

BILLING CODE 8010-01-P


Mark. Riechers@ mercmarine. com Transmission Date: 03/ 15/ 2005 01: 13: 23 PM To: Alan Stout/ AA/ USEPA/ US@ EPA cc: Dave. Oughton@ mercmarine. com, Sue_ Bucheger@ mercmarine. com Subject: Fw: Part 91 Revisions in Word Format Alan,

Your proposed date of manufacture change looks good to us.

Sue Bucheger found another Part 91 error in 91.207. Please see below.

Thanks for your help.

Mark Mark R. Riechers Regulatory Development Manager Mercury Marine W6250 Pioneer Road P. O. Box 1939 Fond du Lac, WI 54936 USA 920 924 1831 920 251 1113 cell mark_ riechers@ mercmarine. com  Forwarded by Mark Riechers/ FDL/ Mercury on 03/ 15/ 2005 12: 07 PM  Sue Bucheger/ FDL/ Mercury 03/ 14/ 2005 04: 47 PM To Dave Oughton/ FDL/ Mercury@ MercuryMarine cc Mark Riechers/ FDL/ Mercury@ MercuryMarine, Bob Sheahan@ MercuryMarine Subject Re: Part 91 Revisions in Word FormatLink This equation is wrong, the minus sign belongs outside the parentheses. Has this been communicated to EPA?

( a) * * * S( t) = exp ( 0.906t/ µ life) 4 * * * * *

Also, I gave Bob S. the other revised equations for him to review. I haven't heard any problems   Bob, can you comment please?

Susan Bucheger Phone: 920 929 4978 Fax: 920 926 6962 Mercury Marine R& D Engine Test & Instrumentation


[Federal Register Volume 83, Number 131 (Monday, July 9, 2018)]
[Notices]
[Pages 31752-31753]
[FR Doc No: 2018-14680]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9980-24-OA]

Request for Nominations of Candidates to the EPA's Science
Advisory Board (SAB) and SAB Standing Committees

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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

SUMMARY: The U.S. Environmental Protection Agency (EPA) invites
nominations of scientific experts from a diverse range of disciplines
to be considered for appointment to the EPA Science Advisory Board
(SAB) and four SAB committees described in this document. Appointments
will be announced by the Administrator and are anticipated to be filled
by the start of Fiscal Year 2019 (October 2018).

DATES: Nominations should be submitted in time to arrive no later than
August 8, 2018.
    Background: The SAB is a chartered Federal Advisory Committee,
established in 1978 under the authority of the Environmental Research,
Development and Demonstration Authorization Act (ERDDAA), codified at
42 U.S.C. 4365, to provide independent scientific and technical peer
review, consultation, advice and recommendations to the EPA
Administrator on the scientific bases for EPA's actions and programs.
Members of the SAB constitute distinguished bodies of non-EPA
scientists, engineers, economists, and behavioral and social scientists
who are nationally and internationally recognized experts in their
respective fields. Members are appointed by the EPA Administrator for a
three-year term and serve as Special Government Employees who provide
independent expert advice to the agency. Additional information about
the SAB is available at http://www.epa.gov/sab.
    Expertise Sought for the SAB: The chartered SAB provides strategic
advice to the EPA Administrator on a variety of EPA science and
research programs. All the work of SAB committees and panels is
conducted under the auspices of the chartered SAB. The chartered SAB
reviews all SAB committee and panel draft reports and determines
whether they are appropriate to send to the EPA Administrator. The SAB
Staff Office invites the nomination of experts to serve on the
chartered SAB in the following scientific disciplines as they relate to
human health and the environment: Analytical chemistry; benefit-cost
analysis; causal inference; complex systems; ecological sciences and
ecological assessment; economics; engineering; geochemistry; health
sciences; hydrology; hydrogeology; medicine; microbiology; modeling;
pediatrics; public health; risk assessment; social, behavioral and
decision sciences; statistics; toxicology; and uncertainty analysis.
    The SAB Staff Office is especially interested in scientists in the
disciplines described above who have knowledge and experience in air
quality; agricultural sciences; atmospheric sciences; benefit-cost
analysis; complex systems; drinking water; energy and the environment;
epidemiological risk analyses; water quality; water quantity and reuse;
ecosystem services; community environmental health; sustainability;
chemical safety; green chemistry; homeland security; and waste
management. For further information about the chartered SAB membership
appointment process and schedule, please contact Mr. Thomas Carpenter,
DFO, by telephone at<PHONE_NUMBER> or by email at
[email protected].
    The SAB Staff Office is also seeking nominations of experts for
possible vacancies on four SAB committees: The Agricultural Science
Committee, the Chemical Assessment Advisory Committee; the Drinking
Water Committee; and the Radiation Advisory Committee.
    (1) The SAB Agricultural Science Committee provides advice to the
chartered SAB on matters that have been determined to have a
significant direct impact on farming and agriculture-related
industries. The SAB Staff Office invites the nomination of scientists
with expertise in one or more of the following disciplines:
Agricultural science, including agricultural economics and valuation of
ecosystem goods and services; agricultural chemistry; agricultural
engineering; agronomy and soil science; animal science; aquaculture
science; biofuel engineering; biotechnology; crop science and
phytopathology; environmental chemistry; forestry; and hydrology. For
further information about the ASC membership appointment process and
schedule, please contact Dr. Shaunta Hill-Hammond, DFO, by telephone at
(202) 564-3343 or by email at [email protected].
    (2) The SAB Chemical Assessment Advisory Committee (CAAC) provides
advice through the chartered SAB regarding selected toxicological
reviews of environmental chemicals. The SAB Staff Office invites the
nomination of scientists with experience in chemical assessments and
expertise in one or more of the following disciplines: Toxicology,
including, developmental/reproductive toxicology, and inhalation
toxicology; carcinogenesis; biostatistics; uncertainty analysis;
epidemiology and risk assessment. For further information about the
CAAC membership appointment process and schedule, please contact Dr.
Suhair Shallal, DFO, by telephone at<PHONE_NUMBER> or by email at
[email protected].
    (3) The SAB Drinking Water Committee (DWC) provides advice on the
scientific and technical aspects of EPA's national drinking water
program. The SAB Staff Office is seeking nominations of experts with
experience on drinking water issues. Members should have expertise in
one or more of the following disciplines: Environmental engineering;
epidemiology; microbiology; public health; toxicology; uncertainty
analysis; and risk assessment. For further information about the DWC
membership appointment process and schedule, please contact Dr. Thomas
Armitage, DFO, by telephone at<PHONE_NUMBER> or by email at
[email protected].

    (4) The Radiation Advisory Committee (RAC) provides advice on
radiation protection, radiation science, and radiation risk assessment.
The SAB Staff Office invites the nomination of experts to serve on the
RAC with demonstrated expertise in the following disciplines: Radiation
carcinogenesis; radiochemistry; radiation dosimetry; radiation
epidemiology; radiation exposure; radiation health and safety;
radiological risk assessment; uncertainty analysis; and radionuclide
fate and transport. For further information about the RAC membership
appointment process and schedule, please contact Dr. Diana Wong, DFO,
by telephone at<PHONE_NUMBER> or by email at [email protected].

Selection Criteria for the SAB and the SAB Committees Includes

--Demonstrated scientific credentials and disciplinary expertise in
relevant fields;
--Willingness to commit time to the committee and demonstrated ability
to work constructively and effectively on committees;
--Background and experiences that would help members contribute to the
diversity of perspectives on the committee, e.g., geographical,
economic, social, cultural, educational backgrounds, professional
affiliations; and other considerations; and
--For the committee as a whole, the collective breadth and depth of
scientific expertise is considered, as well as, a balance of scientific
perspectives.
    As these committees undertake specific advisory activities, the SAB
Staff Office will consider two additional criteria for each new
activity: absence of financial conflicts of interest and absence of an
appearance of a loss of impartiality.
    How to Submit Nominations: Any interested person or organization
may nominate qualified persons to be considered for appointment to
these advisory committees. Individuals may self-nominate. Nominations
should be submitted in electronic format (preferred) using the online
nomination form under the ``Nomination of Experts'' category at the
bottom of the SAB home page at http://www.epa.gov/sab. To be
considered, all nominations should include the information requested
below. EPA values and welcomes diversity. All qualified candidates are
encouraged to apply regardless of gender, race, disability or
ethnicity.
    Nominators are asked to identify the specific committee for which
nominees are to be considered. The following information should be
provided on the nomination form: Contact information for the person
making the nomination; contact information for the nominee; the
disciplinary and specific areas of expertise of the nominee; the
nominee's curriculum vitae; and a biographical sketch of the nominee
indicating current position, educational background; research
activities; sources of research funding for the last two years; and
recent service on other national advisory committees or national
professional organizations. To help the agency evaluate the
effectiveness of its outreach efforts, please indicate how you learned
of this nomination opportunity. Persons having questions about the
nomination process or the public comment process described below, or
who are unable to submit nominations through the SAB website, should
contact the DFO for the committee, as identified above. The DFO will
acknowledge receipt of nominations and in that acknowledgement, will
invite the nominee to provide any additional information that the
nominee feels would be useful in considering the nomination, such as
availability to participate as a member of the committee; how the
nominee's background, skills and experience would contribute to the
diversity of the committee; and any questions the nominee has regarding
membership. The names and biosketches of qualified nominees identified
by respondents to this Federal Register document, and additional
experts identified by the SAB Staff Office, will be posted in a List of
Candidates on the SAB website at http://www.epa.gov/sab. Public
comments on each List of Candidates will be accepted for 21 days from
the date the list is posted. The public will be requested to provide
relevant information or other documentation on nominees that the SAB
Staff Office should consider in evaluating candidates.
    Candidates invited to serve will be asked to submit the
``Confidential Financial Disclosure Form for Special Government
Employees Serving on Federal Advisory Committees at the U.S.
Environmental Protection Agency'' (EPA Form 3110-48). This confidential
form allows EPA to determine whether there is a statutory conflict
between that person's public responsibilities as a Special Government
Employee and private interests and activities, or the appearance of a
loss of impartiality, as defined by Federal regulation. The form may be
viewed and downloaded through the ``Ethics Requirements for Advisors''
link on the SAB home page at http://www.epa.gov/sab. This form should
not be submitted as part of a nomination.

    Dated: June 12, 2018.
Khanna Johnston,
Deputy Director, EPA Science Advisory Board Staff Office.
[FR Doc. 2018-14680 Filed 7-6-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 134 (Tuesday, July 14, 2015)]
[Proposed Rules]
[Pages 40954-40955]
[FR Doc No: 2015-17059]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2014-0626; FRL-9930-26-Region 6]

Approval and Promulgation of Implementation Plans; New Mexico;
Revisions to the Particulate Matter Less Than 2.5 Micrometers (PM2.5)
Prevention of Significant Deterioration (PSD) Permitting Program State
Implementation Plan (SIP)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve portions of two revisions to the New Mexico SIP for the
permitting of PM2.5 emissions submitted on May 23, 2011, and
August 6, 2014. Together, these submittals revise the New Mexico PSD
program to be consistent with the federal PSD regulations regarding the
use of a significant impact level (SIL) or significant monitoring
concentration (SMC) for PM2.5 emissions. We are proposing to
approve these SIP revisions to regulate PM2.5 emissions in
accordance with requirements of section 110 and part C of the Clean Air
Act.

DATES: Written comments must be received on or before August 13, 2015.

ADDRESSES: Comments may be mailed to Ms. Adina Wiley, Air Planning
Section (6PD-R), Environmental Protection Agency, 1445 Ross Avenue,
Ste. 1200, Dallas, TX 75202-2733. Comments may also be submitted
electronically or through hand delivery/courier by following the
detailed instructions in the ADDRESSES section of the direct final rule
located in the rules section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Ms. Adina Wiley,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the final rules section of this Federal
Register, EPA is approving the State's SIP submittals as a direct rule
without prior proposal because the Agency views this as
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no relevant adverse comments are received in response to this
action no further activity is contemplated. If EPA receives relevant
adverse comments, the direct final rule will be withdrawn and all
public comments received will be addressed in a subsequent final rule
based on this proposed rule. EPA will not institute a second comment
period. Any parties interested in commenting on this action should do
so at this time.
    For additional information, see the direct final rule which is
located in the rules section of this Federal Register.

    Dated: June 30, 2015.
Ron Curry,
Regional Administrator, Region 6.
[FR Doc. 2015-17059 Filed 7-13-15; 8:45 am]
 BILLING CODE 6560-50-P


John Cromwell<EMAIL_ADDRESS> 06/01/2004 02:57 PM	To

	'ROBERT RUSSELL'<EMAIL_ADDRESS> 	cc

	Nimmi Damodaran<EMAIL_ADDRESS>Margaret

Sheppard/DC/USEPA/US@EPA

	bcc

	Subject

	RE: Latest Adhesive Retail Pricing Update

Thanks Bob.

-----Original Message-----

From: ROBERT RUSSELL<EMAIL_ADDRESS> Sent: Tuesday, June 01, 2004 1:27 PM

To<EMAIL_ADDRESS> Subject: Latest Adhesive Retail Pricing Update

John,

Did some screening on adhesive pricing on a number of sites and prices

seem to be up somewhat; an average of about 10-12 %, most likely due to

the barrel price for crude. This impacts the solvent costs and also the

active resin contained in the adhesive, since they all tend to originate

at the well-head. Water based materials have been raised the least amount,

as they only have to account for their oil-based resin components.

n-PB based adhesives:  $17.60- 19.00 / gal

Methylene chloride-based adhesives:  $ 7.60- 8.20 / gal.

Water-based adhesives:  $ 7.35-7.75 / gal.

Acetone-based adhesives: $ 6.65-7.00 / gal.

Prices seemed to move up in proportion with each other, so it hasn't

changed the ranked order of material costs any. Hope this helps.

Regards,

Bob