[Federal Register: November 5, 2007 (Volume 72, Number 213)]
[Proposed Rules]
[Page 62422-62427]
[DOCID:fr05no07-13]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2006-1018; A-1-FRL-8491-1]

Approval and Promulgation of Air Quality Implementation Plans;
Massachusetts; Amendment to Massachusetts' State Implementation Plan
for Transit System Improvements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The EPA is proposing to approve a State Implementation Plan
(SIP) revision submitted by the Commonwealth of Massachusetts. This
revision changes completion dates of delayed transit projects, provides
interim deadlines for projects, maintains interim emission reduction
offsets for delays in projects, modifies the project substitution
process, revises the list of required transit projects, and expands
public participation and oversight of the transit transportation
control measure projects. The intended effect of this action is to
propose approval of specific named substitution projects to the State
Implementation Plan's transportation control measure projects, and
approve modifications to the delay and substitution procedures for
transit projects. This action is being taken under the Clean Air Act.

DATES: Written comments must be received on or before December 5, 2007.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R01-OAR-2006--1018 by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``Docket Identification Number EPA-R01-OAR-2006-1018'',
Anne Arnold, U.S. Environmental Protection Agency, EPA New England
Regional Office, One Congress Street, Suite 1100 (mail code CAQ),
Boston, MA 02114-2023.
    5. Hand Delivery or Courier: Deliver your comments to: Anne Arnold,
Manager, Air Quality Planning Unit, Office of Ecosystem Protection,
U.S. Environmental Protection Agency, EPA New England Regional Office,
One Congress Street, 11th floor, (CAQ), Boston, MA 02114-2023. 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 legal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R01-OAR-
2006-1018. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://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 http://www.regulations.gov
, or e-mail, information that you consider to be CBI

or otherwise protected. The http://www.regulations.gov Web site is an

``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
http://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 http://www.regulations.gov
 or in hard copy at Office of Ecosystem Protection,

U.S. Environmental Protection Agency, EPA New England Regional Office,
One Congress Street, Suite 1100, Boston, MA. EPA requests that if at
all possible, you contact the contact 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 legal holidays.
    In addition, copies of the state submittal are also available for
public inspection during normal business hours, by appointment at the
Bureau of Waste Prevention, Massachusetts Department of Environmental
Protection, One Winter Street, 8th Floor, Boston, MA 02108.

FOR FURTHER INFORMATION CONTACT: Donald O. Cooke, Air Quality Planning
Unit, U.S. Environmental Protection Agency, EPA New England Regional
Office, One Congress Street, Suite 1100 (CAQ), Boston, MA 02114-2023,
telephone number<PHONE_NUMBER>, fax number<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us'' and ``our'' is used, we mean EPA.
    Organization of this document. The following outline is provided to
aid in locating information in this preamble.

I. Background and Purpose
II. Summary of Changes to 310 CMR 7.00 and 7.36
III. Results of EOT's Demonstration of Air Quality Emission
Reductions

IV. Criteria for Approving Amendments to the Transit System
Improvements Regulation into the SIP
V. Transportation Control Measure (TCM) Substitution and SAFETEA-LU
VI. Proposed Action
VII. Statutory and Executive Order Reviews

I. Background and Purpose

    EPA approved the Massachusetts Transit System Improvements
Regulation (the Regulation), 310 CMR 7.36 (effective December 6, 1991),
into the Massachusetts State Implementation Plan (SIP) on October 4,
1994 (59 FR 50495--50498). The transit system improvement projects
contained in the Regulation include transportation control measures
deemed necessary to mitigate the air quality impacts of the Central
Artery and Third Harbor Tunnel Project in Metropolitan Boston.
    On December 13, 2006, the Massachusetts Department of Environmental
Protection (MA DEP) submitted a revision to its SIP amending its
Transit System Improvements Regulation. The revision consists of MA
DEP's final amendments to 310 CMR 7.36, ``Transit System
Improvements,'' effective December 1, 2006. MA DEP held a hearing on
the amendments to the Regulation on December 21, 2005. On June 1, 2007,
MA DEP supplemented its SIP revision with a letter determining that
Massachusetts Executive Office of Transportation (EOT) had met the
requirements of 310 CMR 7.36 (8), Demonstration of Air Quality
Emissions Reductions, along with EOT's air quality modeling analysis
(``Description of Modeling Assumptions and Analysis Methodology for the
State Implementation Plan Transit Commitment Projects Current and
Proposed Substitutions,'' dated March 15, 2007). EOT held a public
comment period on this supplemental material for a 45-day period
commencing on January 2, 2007. The document was amended based on
comments received and an additional two-week public comment period
began on March 21, 2007, following posting in the ``Environmental
Monitor.'' DEP submitted EOT's responses to public comments received as
part of the supplemental materials.
    On August 22, 2007, we issued our determination that the
Massachusetts SIP package is administratively and technically complete.
In our completeness determination, we also highlighted EPA's interest
in seeing that the transit projects are implemented in a timely manner
and requested that MA DEP keep us apprised of the status of the
replacement projects as they move forward. In addition, we specifically
mentioned hearing recent reports of potential delays in the Green Line
extension project and encouraged Massachusetts Executive Office of
Transportation (EOT) to address this issue on the record at the
upcoming September 6, 2007 public meeting.
    On September 6, 2007, the MA DEP held a public meeting to address
EOT's annual status report on transit commitments. EOT presented the
status of the uncompleted transit projects and took public comment.
David Mohler, Acting Deputy Secretary for Planning, EOT, explained the
Commonwealth's efforts in seeking Federal funds for the Green Line,
which could delay the completion of the Green Line for up to two years.
Mohler emphasized EOT's position to make up any time delay, and if a
delay occurred, to propose mitigation projects and adequate emission
offsets as required by the regulation. EOT also made available at the
public meeting a September 4, 2007, letter from David Mohler to MA
DEP's Acting Commissioner, Arlene O'Donnell, committing to accelerate
the planning, design and environmental review and permitting of the
project in order to meet the 2014 completion date.

II. Summary of Changes to 310 CMR 7.00 and 7.36

    Listed below are the changes in Massachusetts Department of
Environmental Protection's Air Pollution Control Regulations 310 CMR
7.00, ``Statutory Authority; Legend; Preamble; Definitions,'' and 310
CMR 7.36, ``U Transit System Improvements'' which went into effect on
December 1, 2006 at the state level. EPA is proposing approval of these
changes as a SIP revision.

Definitions

    The following definition of ``Boston Metropolitan Planning
Organization'' (MPO) is added and included in 310 CMR 7.00: ``BOSTON
METROPOLITAN PLANNING ORGANIZATION means the organization designated
for maintaining a continuing, cooperative, and comprehensive (3C)
transportation planning process under Section 134 of the Federal Aid
Highway Act and Section 5303 of the Federal Transit Act, as amended, in
the Boston metropolitan region.''

Revisions to the List of Required Projects

    The Green Line Arborway Restoration, the Blue Line Connection from
Bowdoin Station to the Red Line at Charles Station, and the Green Line
extension to Ball Square/Tufts University, will be replaced by the
Fairmont Line Project (construction to be completed and opened to full
public use by December 31, 2011), 1000 new park and ride parking spaces
(construction to be completed and opened to full public use by December
31, 2011) and an enhanced Green Line Extension Project (construction to
be completed and opened to full public use by December 31, 2014). The
Green Line Arborway Restoration was originally assigned a completion
date of December 31, 1997, with an extension to December 31, 2000
previously granted pursuant to the Regulation, and project emission
offsets required to mitigate the delay after December 31, 2000 until
project completion. The Blue Line connection and the Green Line
extension to Ball Square/Tufts University were originally assigned a
completion date of December 31, 2011.

The New Replacement/Substitution Projects

    ``The Fairmount Line Project.'' The Fairmount commuter rail line is
approximately 9.2 miles long, running from South Station to Readville,
passing through the communities of Dorchester, Roxbury and Mattapan.
Fairmount Line improvements will consist of: Enhancements of existing
stations including, without limitation, platform extensions, improved
lighting and improved access; a new Four Corners Station plus a new
station in each of the neighborhoods of Dorchester, Mattapan and
Roxbury; and bridge upgrades and other measures to improve service and
increase ridership.
    ``1000 new park and ride parking spaces.'' These 1000 new park and
ride parking spaces are in addition to those required by 310 CMR
7.36(2)(c)3 and 310 CMR 7.36(2)(d), and will serve commuter transit
facilities, within the 101 cities and towns constituting the Boston
Metropolitan Planning Organization.
    ``The Green Line Extension Project.'' The Green Line extension
consists of extending the Green Line from Lechmere Station to Medford
Hillside and construction of a spur to Union Square.
    ``The Red Line/Blue Line Connector.'' The revision requires final
design of the connection from the Blue Line at Government Center to the
Red Line at Charles Station before December 31, 2011, but no longer
commits to its construction.

Revised Deadlines

    Old Colony Commuter Rail Extension Greenbush Line, originally
assigned a completion date of December 31, 1996, must now be completed
and open to full public use before December 31, 2007. Project emission
offsets were required to

mitigate the delay of the Greenbush spur after December 31, 1999 until
project completion.
    Blue Line Platform Lengthening and Modernization, originally
assigned a completion date of December 31, 1998, with an extension to
December 31, 2008 previously granted pursuant to the Regulation, must
now be completed and open to full public use before December 31, 2008.
Project emission offsets were required to mitigate the delay after
December 31, 2001 until project completion.

Project Interim Deadlines

    MA DEP has added interim project deadlines for the Fairmount Line
improvements, the Green Line extension to Medford Hillside, the Green
Line Union Square spur, and the 1000 Park and Ride parking spaces. EPA
believes these interim milestones, in combination with the EOT's annual
reporting on the status of the transit commitments, will help keep the
transit system improvements projects construction on schedule.

New Requirements Added To Address Potential Project Delays of the New
Projects

    If the Fairmount Line improvements, the Green Line extension to
Medford Hillside, the Green Line Union Square spur, or 1000 Park and
Ride spaces are delayed, interim air quality offset projects are
required to be implemented. The revised regulation does not place a
limit on the amount of time EOT may delay a project, as long as it
obtains offsets for the delay.
    EOT is required to petition MA DEP to delay a project, and the
petition will undergo ``public review'' before MA DEP acts on the
petition.

Substitution Criteria

    Projects may be substituted after completion of specified interim
project deadlines. The revised Regulation no longer requires a finding
that the project to be replaced is ``infeasible.''
    Substitution determinations require an EOT public meeting and a
public comment period.
    The proposed substitute project must achieve 110% of the emission
reductions that would have been achieved by the original project to be
replaced.
    EOT must implement interim emission reduction offsets to address
any delay in achieving the emission reductions that would have been
achieved had all components of the original project been completed on
time.
    Project substitutions may proceed after MA DEP determines in
writing that EOT has met the substitution provisions of the Regulation.

Potential Future Project Substitutions

    The Green Line Extension may be substituted with transit projects
in Boston, Cambridge, Somerville, or Medford.
    The Fairmount Line project may be substituted with transit projects
in Dorchester, Hyde Park, Mattapan, or Roxbury.

Public Process Requirements

    EOT is required to conduct an annual public meeting to provide a
thorough update and status report on each project and to disclose any
need for potential or actual project delays and/or substitutions.
    EOT is required to submit an annual certification to MA DEP with a
commitment to complete and fund projects and disclose project delays/
substitutions/interim offset measures to be implemented.

Development of Emission Reduction Baseline

    MA DEP added a new Subsection 8 to provide substantive public
comment on the air quality modeling for the Regulation and EOT's
remodeling of the revised transit projects.
    EOT must calculate baseline emission reductions by modeling the
original three projects, the Green Line Arborway Restoration, the Blue
Line-Red Line Connection, and the Green Line extension to Ball Square,
and adding 10% to the total.
    EOT is required to demonstrate that new projects will deliver the
required baseline emission reductions. If the new projects do not
deliver the baseline emission reductions, EOT is required to implement
additional projects in the same geographic areas.
    EOT is required to take public comment on the results of the
emission analysis and respond to those comments.

Demonstration of Emission Reductions

    When all projects required by 310 CMR 7.36 are substantially
complete, EOT shall complete an analysis of the total air quality
benefits of such projects. EOT shall perform such analysis in
accordance with EPA requirements in effect at the time of the analysis.

III. Results of EOT's Demonstration of Air Quality Emission Reductions

    MA DEP's supplemental SIP revision submitted to EPA on June 1,
2007, contained MA DEP's determination that EOT had met the
requirements of 310 CMR 7.36(8)(d) and (e) and that the
``administrative record reasonably supports the results and conclusions
of the report required pursuant to 310 CMR 7.36(8)(c).'' Thus, MA DEP
agreed that EOT has demonstrated that the new projects achieve at least
110% of the emissions reductions that would have been achieved by the
projects being replaced.
    In addition, the supplement included EOT's air quality modeling
demonstration mandated by 310 CMR 7.36(8)(a) through (8)(e) entitled,
``Description of Modeling Assumptions and Analysis Methodology for the
State Implementation Plan Transit Commitment Projects Current and
Proposed Substitutions March 15, 2007,'' prepared by the Boston MPO's
Central Transportation Planning Staff for the Executive Office of
Transportation Office of Transportation. These documents are part of
the publicly available docket materials accessible for inspection
electronically in the Federal Docket Management System at http://www.regulations.gov
, Docket Number EPA-R01-OAR-2006-1018.

    EOT's air quality analysis modeled the emissions reductions of: (1)
The original SIP-approved package of projects; (2) the replacement/
substitution package of projects; and (3) the no-build or baseline
scenario. This analysis concluded that the substitution projects (Green
Line to Union Square and Medford Hillside, Fairmont Line Improvements,
and Additional Parking) results in reductions of 435 kilograms per day
of Carbon Monoxide (CO), 11 kilograms per day of Nitrogen Oxides
(NOX), and 17 kilograms of Volatile Organic Compounds (VOC)
over the no-build baseline. The package of transit projects are
estimated to result in emission reductions in 2025 of 149% CO, 137.5%
NOX and 154% VOC of the original SIP-approved projects,
which are in excess of the 110% emission reduction required by
subsection (5)(f) of the amended transit system improvements
regulation. For all three pollutants, CO, NOX and VOC [MA
DEP's regulations refers to hydrocarbon emissions (VOC) as non-methane
hydrocarbons--NMHC], MA DEP's requirement of 110% threshold is met.
Please see Table 1 ``EOT Air Quality Analysis Comparison of Project
Packages Benefits in the Year 2025,'' below.

           Table 1.--EOT Air Quality Analysis Comparison of Project Packages Benefits in the Year 2025
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                                                                      Daily emission benefits in kilograms (kg.)
                                                                    --------------------------------------------
                                                                                Volatile
                                                                         Carbon        Nitrogen       organic
                                                                        monoxide    oxides  (NOX)    compounds
                                                                          (CO)                         (VOC)
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SIP Approved Projects (Package):
    Arborway Restoration, Green Line Extension to Ball Square/Tufts          292              8             11
     University, and Blue Line/Red Line Connection (Bowdoin Station
     to Charles Station)...........................................
SIP Approved Projects (Package) Plus Ten Percent...................          321.2            8.8           12.1
Replacement/Substitution Projects (Package):
    Green Line to Union Square and Medford Hillside, Fairmont Line           435             11             17
     Improvements, and Additional Parking..........................
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IV. Criteria for Approving Amendments to the Transit System
Improvements Regulation Into the SIP

    EPA's role is to approve state choices, provided that they meet the
criteria of the Clean Air Act. An adequate SIP revision is one that
meets the Clean Air Act's requirement under section 110(l) that a SIP
revision must not interfere with attainment and maintenance of national
ambient air quality standards (NAAQSs). The Commonwealth has
flexibility to revise SIP-approved transportation control measures
(TCMs), provided the revisions are consistent with attaining and
maintaining compliance with the NAAQSs. In addition, the Safe,
Accountable, Flexible, Efficient Transportation Equity Act: A Legacy
For Users (SAFETEA-LU) section 6011(d) amended the Clean Air Act by
adding a new section 176(c)(8) that establishes specific criteria and
procedures for replacing TCMs in an existing approved SIP with new TCMs
and adding TCMs to an approved SIP. As discussed below, MA DEP's
Regulation does not need to comply with all elements of section
176(c)(8) to be approvable as a SIP revision, but it must not conflict
with any of those elements.
    The Federal executive policy on environmental justice is
established by Executive Order (EO) 12898, ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations,'' (59 FR 7629 (Feb. 16, 1994)). Its main provision directs
federal agencies, to the greatest extent practicable and permitted by
law, to make environmental justice part of their mission by identifying
and addressing, as appropriate, disproportionately high and adverse
human health or environmental effects of their programs, policies, and
activities on minority populations and low-income populations in the
United States. Here the Clean Air Act directs EPA to approve a SIP
revision unless it does not meet the Act's requirements. Although the
Act does not provide EPA the authority to modify the Commonwealths'
regulatory decision solely on the basis of environmental justice
considerations, EPA continues to encourage EOT to consider
environmental justice concerns when deciding the location of the
additional Park and Ride spaces and the new stations along the
Fairmount commuter rail line and the Green Line extension project. EPA
also urges EOT and DEP to consider environmental justice concerns when
deciding whether to meet project deadlines, to approve proposals for
project delays, and to approve offset or substitute projects.

V. Transportation Control Measure (TCM) Substitution and SAFETEA-LU

    Clean Air Act section 176(c)(8), added by SAFETEA-LU, establishes
the procedures for ensuring that substitute TCMs provide equal or
greater emissions reductions than the TCMs that are being replaced. It
also establishes the process for EPA and state air agency concurrence
on the substitution or addition of TCM projects. Finally, it ensures
that the state and EPA maintain up-to-date information on the TCMs in
approved SIPs so that the public is aware of the TCMs that are to be
implemented. EPA and U.S. Department of Transportation (DOT) issued
joint guidance on February 14, 2006, on the implementation of all of
the Clean Air Act amendments made by SAFETEA-LU. This guidance
clarified EPA and DOT expectations for how TCM substitutions and
additions are to be carried out by state and local agencies. The
guidance is available at http://www.epa.gov/otaq/stateresources/transconf/420b06901.pdf.
\1\

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    \1\ EPA has proposed regulations to implement SAFETEA-LU, but
specifically declined to propose regulations addressing section
176(c)(8), finding that the statute is already sufficiently detailed
and that the EPA/DOT guidance would address questions that might
arise about TCM substitutions. (72 FR 24472, 24485-24486; May 2,
2007).
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    As explained in the guidance, section 176(c)(8) applies directly to
any TCM substitution made in a SIP, whether or not the SIP already
includes a substitution mechanism designed by a state and approved by
EPA. The section does not eliminate the requirement to comply with any
such substitution procedures in a SIP, even if the state includes
requirements that go beyond the minimum elements required under section
176(c)(8). Correspondingly, complying with the substitution process in
the SIP does not eliminate the requirement to meet all the elements of
the process laid out in section 176(c)(8). In the unlikely event there
is a conflict between section 176(c)(8) and the SIP substitution
process, the substitution must comply with section 176(c)(8). See EPA/
DOT Guidance at pages 20-21, section 5.2.
    Therefore, for the purposes of this SIP approval, EPA must
determine whether any element of the MA DEP Transit System Improvements
Regulation conflicts with section 176(c)(8). EPA sees no conflict
between the requirements of the MA DEP Regulation and section
176(c)(8). There are provisions in the MA DEP Regulation that go beyond
the requirements of section 176(c)(8), such as the requirement to
demonstrate that the substitution achieves an extra 10% emissions
reduction beyond that achieved by the projects being replaced or the
specific geographic limits on substitute projects. But EPA has found no
instance in which complying with the MA DEP regulation would result in
a conflict with or violate any corresponding requirement of section
176(c)(8).
    In addition, EPA must work with MA DEP to ensure that any
requirements in section 176(c)(8) that are not addressed in its
Regulation will be met. There appear to be two requirements in

section 176(c)(8) that are not provided for in the MA DEP Regulation.
    First, in addition to the state air pollution control agency,
section 176(c)(8)(A)(v) specifically requires both the MPO and EPA to
concur with the equivalency of the substitute TCM before the
substitution can take effect. On May 3, 2007, Massachusetts Secretary
of Transportation, Bernard Cohen, submitted EOT's air quality modeling
analysis for the substitution projects to MA DEP. This analysis
demonstrates that the required emission reductions set forth in section
7.36(8) of the Regulation will be achieved by the new projects. All
that remains is for the MPO to submit evidence to EPA that the MPO
concurs in that analysis. For EPA's concurrence on the substitutions
included in this SIP revision, the Agency will send a letter,
contemporaneous with our final action on this SIP revision, to document
EPA's concurrence on the substitutions being approved with the
revisions to MA DEP's regulation.\2\ For any future substitutions, EPA
will work with MA DEP to coordinate EPA's review with DEP's review of
the proposed substitution so that the substitution can take effect as a
matter of federal law if both DEP and EPA approve it.
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    \2\ Both the authority to approve this SIP revision and the
authority to concur on TCM substitutions under section 176(c)(8)
have been delegated to the Regional Administrator. See EPA
Delegations of Authority Nos. 7-10 (Approval/Disapproval of State
Implementation Plans) and 7-158 (Transportation Control Measure
Substitutions and Additions). Note that while EPA is using an
informal rulemaking to act on this proposed SIP revision, we are not
interpreting section 176(c)(8)(A)(v) to require a rulemaking to
accomplish EPA's concurrence. See EPA/DOT Guidance at page 27,
section 5.17. Indeed, section 176(c)(8) was added to the Act
precisely to avoid the need for a full SIP revision to implement TCM
substitutions in the routine case. In this instance, where the TCM
substitution is occurring as part of a proposed SIP revision, EPA is
simply acting on the SIP in a rulemaking under section 110 of the
Act contemporaneous with any concurrence on the substitution in a
letter to MA DEP under section 176(c)(8) of the Act.
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    Second, section 176(c)(8) now requires all substitutions of TCM's
to be submitted to EPA for incorporation into the codification of the
SIP. For the purposes of the substitutions provided for in the
revisions of the Regulation, EPA is proposing that any codification
that results from our final action on this SIP revision will address
this requirement. For future substitutions, although the Regulation
does not specifically require MA DEP to forward to EPA the results of
MA DEP's substitution determinations, it should be a routine matter for
MA DEP to submit any substitution it approves under section 7.36(5)(h)
so that the federally approved SIP can accurately reflect the current
requirements under the Regulation.
    EPA's review of Massachusetts' SIP Revision indicates the
amendments to the SIP-approved Massachusetts Transit System
Improvements, with substitution projects and changes to projects
timelines, adequately demonstrate continued emission reductions and do
not relax current provisions in the SIP. EPA is proposing to approve
the Massachusetts SIP revision for Transit System Improvements, which
was submitted on December 13, 2006, and supplemented on June 1,
2007.\3\ EPA is soliciting public comments on the issues discussed in
this notice or on other relevant matters. These comments will be
considered before taking final action. Interested parties may
participate in the Federal rulemaking procedure by submitting written
comments to the EPA New England Regional Office listed in the ADDRESSES
section of this Federal Register.
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    \3\ In addition, EPA is planning to concur pursuant to section
176(c)(8) that the substitute TCM's achieve equivalent or greater
emission reductions than the measures being replaced.
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VI. Proposed Action

    EPA is proposing to approve Massachusetts' amendments to Transit
System Improvements Regulation, 310 CMR 7.36, and Definition
Regulation, 310 CMR 7.00 (which were filed with the Massachusetts
Secretary of State on November 16, 2006 and were effective on December
1, 2006,) as a revision to the Massachusetts SIP. EPA finds that the
transit measures in the revised transit system improvements regulation
remain directionally sound and that all proposed substitution projects
identified in the Regulation will collectively contribute to achieving
the national ambient air quality standard for ozone and maintaining the
carbon monoxide standard, thereby satisfying requirements set forth in
Section 110(l) of the Clean Air Act.

VII. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it 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).
    This rule also does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This action also does not have Federalism
implications because it does not have substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999), because it merely approves a state rule
implementing a Federal standard, and does not alter the relationship or
the distribution of power and responsibilities established in the Clean
Air Act. This rule also is not subject to Executive Order 13045
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), or Executive Order 12898
``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations,'' because it approves a state
rule implementing a Federal standard.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not
impose an information collection burden under the provisions of the

Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

List of Subjects in 40 CFR Part 52

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

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

    Dated: October 25, 2007.
Robert W. Varney,
Regional Administrator, EPA New England.
[FR Doc. E7-21691 Filed 11-2-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 162 (Monday, August 22, 2016)]
[Notices]
[Page 56652]
[FR Doc No: 2016-20027]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9951-03-Region 4; CERCLA-04-2016-3754]

Forshaw Chemicals Superfund Site Charlotte, Mecklenburg County,
North Carolina; Notice of Settlement

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Settlement.

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

SUMMARY: Under 122(h) of the Comprehensive Environmental Response,
Compensation and Liability Act (CERCLA), the United States
Environmental Protection Agency (EPA) has entered into a settlement
with Thomas Forshaw III, Forshaw Industries, Inc., Forshaw Chemicals
Incorporated, Forshaw Distribution, Inc., and Bess C. Forshaw,
concerning the Forshaw Chemicals Superfund Site located in Charlotte,
Mecklenburg County, North Carolina. The settlement addresses recovery
of CERCLA costs for a cleanup action performed by the EPA at the Site.

DATES: The Agency will consider public comments on the settlement until
September 21, 2016. The Agency will consider all comments received and
may modify or withdraw its consent to the proposed settlement if
comments received disclose facts or considerations which indicate that
the proposed settlement is inappropriate, improper, or inadequate.

ADDRESSES: Copies of the settlement are available from the Agency by
contacting Ms. Paula V. Painter, Program Analyst, using the contact
information provided in this notice. Comments may also be submitted by
referencing the Site's name through one of the following methods:
    Internet: https://www.epa.gov/aboutepa/about-epa-region-4-southeast#r4-public-notices.
     U.S. Mail: U.S. Environmental Protection Agency, Superfund
Division, Attn: Paula V. Painter, 61 Forsyth Street, SW., Atlanta,
Georgia 30303.
     Email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Paula V. Painter at 404/562-8887.

    Dated: July 28, 2016.
Greg Armstrong,
Acting Chief, Enforcement and Community Engagement Branch, Superfund
Division.
[FR Doc. 2016-20027 Filed 8-19-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 66 (Thursday, April 5, 2012)]
[Notices]
[Pages 20622-20623]
[FR Doc No: 2012-8160]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2744-041; 2744-042]

N.E.W. Hydro LLC; Notice of Application for Amendment of License
and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Amendment of License.
    b. Project No.: 2744-041 & 042.
    c. Date Filed: March 14, 2012.
    d. Applicant: N.E.W. Hydro LLC.
    e. Name of Project: Menominee/Park Mill Hydro Project.
    f. Location: The project is located on the Menominee River in
Marinette County, Wisconsin and Menominee County, Michigan.

    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Scott Klabunde, P.O. Box 167, 116 N.
State Street, Neshkoro, WI 54869-0167,<PHONE_NUMBER>, Ext. 14.
    i. FERC Contact: John K. Novak,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: April 30, 2012.
    All documents may be filed electronically via the Internet. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support. Although the Commission strongly encourages electronic filing,
documents may also be paper-filed. To paper-file, mail an original and
seven copies to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE., Washington, DC 20426.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Application: N.E.W. Hydro LLC seeks approval to
construct an angled fish guidance rack with bypass to guide downstream
migrating fish around the powerhouse and dam at the Park Mill
development, described as Phase 1 of the four phases of the Menominee/
Park Mill Fish Passage and Protection Plan (Plan). N.E.W. Hydro LLC is
also requesting approval to construct a fish lift with sorting/holding
facilities to provide upstream passage at the Menominee development,
described as Phase 2 of the Plan. The lake sturgeon is the primary
target species for upstream and downstream passage around both dams.
All construction activities associated with Phases 1 and 2 will take
place within the project boundary and will not require additional
lands. Phases 3 and 4 of the plan are not proposed at this time but
will instead be the subject of future amendment applications.
    l. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number (P-2744-041 & 042) excluding the last
three digits in the docket number field to access the document. For
assistance, contact FERC Online Support. A copy is also available for
inspection and reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    Any filings must bear in all capital letters the title
``COMMENTS,'' ``PROTEST,'' or ``MOTION TO INTERVENE,'' as applicable,
and the Project Number of the particular application to which the
filing refers. A copy of any motion to intervene must also be served
upon each representative of the Applicant specified in the particular
application.
    o. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

    Dated: March 29, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-8160 Filed 4-4-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 18 (Tuesday, January 28, 2020)]
[Notices]
[Pages 4994-4997]
[FR Doc No: 2020-01408]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5900]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Endorser Status and Explicitness of Payment in Direct-
to-Consumer Promotion

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) 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 a proposed study entitled ``Endorser Status and
Explicitness of Payment in Direct-to-Consumer Promotion.''

DATES: Submit either electronic or written comments on the collection
of information by March 30, 2020.

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 March 30, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 30, 2020. 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-2019-N-5900 for ``Endorser Status and Explicitness of Payment in
Direct-to-Consumer Promotion.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' 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.

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>    For copies of the questionnaire contact: Office of Prescription
Drug Promotion (OPDP) Research Team<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.

Endorser Status and Explicitness of Payment in Direct-to-Consumer
Promotion; OMB Control Number 0910-NEW

I. Background

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes 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
promotional material is truthful, balanced, and accurately
communicated, so that patients and healthcare providers can make
informed decisions about treatment options. 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 research data through analytical methodology development and
investigation of sampling and response issues. This study will inform
the first topic area.
    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/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. 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.
    Advertisers have used celebrity endorsers for years, and DTC
pharmaceutical promotion is no different. As researchers studied the
influence of celebrity endorsers, they theorized that a correspondence
bias occurs in which people believe that the endorser truly believes
what they are saying. LaTour and Smith (Ref. 1) examined whether a
pharmacist, physician, celebrity, or consumer would be most persuasive
in advertisements for four different types of OTC products. They found
that physicians and pharmacists were the most likely to lead to
purchase intentions, followed by consumers, and lastly, by celebrities.
There were no differences among types of OTC product.
    Bhutada and Rollins (Ref. 2) recently completed a study examining
the role of endorser type (i.e., celebrity vs. expert vs. non-
celebrity), and endorser and consumer gender in product DTC ads. They
found, like LaTour and Smith (Ref. 1), that expert endorsers were
thought of as higher in credibility and generally resulted in the same
amount of attention as celebrities. The authors did not find that these
endorsers resulted in greater intentions to pursue the drug product.
    We propose to extend previous research by examining four types of
endorsers in two separate studies (celebrity, physician, patient,
influencer \1\) and examining whether the presence of a disclosure of
their payment status influences participant reactions. We propose to
also test two different types of disclosure language--one direct and
more consumer-friendly, and one less direct.
---------------------------------------------------------------------------

    \1\ ``Influencer'' is a ``regular'' person who has gained a
following on a blog, a Twitter feed, or other social media medium.
---------------------------------------------------------------------------

    To complete this research, we propose the following concurrent
studies.\2\
---------------------------------------------------------------------------

    \2\ For case allocation, the literature suggests that some
proportion of consumers may not recall seeing the disclosure
statement in the advertisement (see, for example, Boerman et al.,
Ref. 3). Rather than allotting equal numbers of cases to each
condition, we will assign more cases to the disclosure present
condition to increase power in these cells.
---------------------------------------------------------------------------

Study A

                                        Table 1a--Study 1 Design--Pretest
                                [0.80 power, 0.10 alpha, small effect size f=.2]
----------------------------------------------------------------------------------------------------------------
                                                                   Endorser
             Payment disclosure              ---------------------------------------------------      Total
                                                 Celebrity        Physician         Patient
----------------------------------------------------------------------------------------------------------------
Present.....................................              50               50               50              150
Absent......................................              33               33               33               99
                                             -------------------------------------------------------------------
    Total...................................              83               83               83              249
----------------------------------------------------------------------------------------------------------------

                                      Table 1b--Study 1 Design--Main Study
                                [0.90 power, 0.05 alpha, small effect size f=.2]
----------------------------------------------------------------------------------------------------------------
                                                                   Endorser
             Payment disclosure              ---------------------------------------------------      Total
                                                 Celebrity        Physician         Patient
----------------------------------------------------------------------------------------------------------------
Present.....................................              81               81               81              243
Absent......................................              54               54               54              162
                                             -------------------------------------------------------------------
    Total...................................             135              135              135              405
----------------------------------------------------------------------------------------------------------------

    Study A will manipulate endorser type (three levels: Celebrity,
physician, patient) and payment disclosure (two levels: Present,
absent) within a print DTC ad for a fictitious acne product. For this
study, we will recruit 654 general population individuals (249 pretest;
405 main study) from a national nonprobability internet panel called
Dynata, formerly ResearchNow. All participants must report familiarity
with the celebrity to be included in our study. The celebrity will be
one who has publicly spoken out about acne. We are not divulging the
identity of the celebrity in this public forum to maintain the
integrity of our research process. Stock photos will be used to depict
a physician and a patient in the other experimental conditions.
Participants will be randomly assigned to see one of the endorsers and
to see the ad either with or without a payment disclosure. The payment
disclosure in Study 1 will be determined in cognitive testing, but will
be similar to: ``[Endorser] has been paid to appear in this ad for Drug
X.''
Study B

                                        Table 2a--Study 2 Design--Pretest
                                [0.80 power, 0.10 alpha, small effect size f=.2]
----------------------------------------------------------------------------------------------------------------
                                                                           Endorser
                      Payment Disclosure                      ----------------------------------      Total
                                                                  Influencer        Patient
----------------------------------------------------------------------------------------------------------------
Present-Direct...............................................              50               50              100
Present-Indirect.............................................              50               50              100
Absent.......................................................              33               33               66
                                                              --------------------------------------------------
    Total....................................................             133              133              266
----------------------------------------------------------------------------------------------------------------

                                      Table 2b--Study 2 Design--Main Study
                                [0.90 power, 0.05 alpha, small effect size f=.2]
----------------------------------------------------------------------------------------------------------------
                                                                           Endorser
                      Payment Disclosure                      ----------------------------------      Total
                                                                  Influencer        Patient
----------------------------------------------------------------------------------------------------------------
Present-Direct...............................................              81               81              162
Present-Indirect.............................................              81               81              162
Absent.......................................................              54               54              108
                                                              --------------------------------------------------
    Total....................................................             216              216              432
----------------------------------------------------------------------------------------------------------------

    In Study B we will also manipulate endorser type, examining a
patient and an internet influencer, one who provides online content to
a number of followers. We will also manipulate the explicitness of the
payment disclosure in addition to its presence, resulting in a two
(endorser: Influencer, patient) by three (payment disclosure: Present-
direct, present-indirect, absent) between-subjects design. The
disclosure will be direct (e.g., ``Paid ad . . .''), indirect (e.g.,
#sp for ``sponsored''), or absent. The setting for this study will be
an Instagram post for a fictitious endometriosis product. This study
partially replicates Study A and extends it by further tweaking the
explicitness of payment as another manipulated variable and using a
different set of

endorser types and in a different promotional setting.
    For Study B, we will recruit 698 (266 pretest; 432 main study)
followers of an internet influencer who maintains an Instagram page
with more than 500,000 followers and has posted about endometriosis. As
in the first study, we are not revealing the influencer's identity to
maintain the integrity of the study.
    In both studies, we are interested in the role of endorsement and
payment status on participants' recall, benefit and risk perceptions,
and behavioral intentions. Participants will view one promotional piece
and answer questions via the internet. The study is expected to take
less than 20 minutes to complete. Dependent variables will include
attention to disclosure statement and risk/benefit information;
retention of risk/benefit information; recognition of piece as
promotion and endorser as paid; perceived benefits and risks, attitudes
toward the product, endorser, and ad; and behavioral intentions such as
asking a doctor about the drug.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 3--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent      respondents     per response
----------------------------------------------------------------------------------------------------------------
Study 1 Screener..............             933               1             933  0.08 (5 minutes)           74.64
Study 1 Pretest...............             249               1             249  0.33 (20                   82.17
                                                                                minutes).
Study 1 Main test.............             405               1             405  0.33 (20                  133.65
                                                                                minutes).
Study 2 Screener..............           1,417               1           1,417  0.08 (5 minutes)          113.36
Study 2 Pretest...............             266               1             266  0.33 (20                   87.78
                                                                                minutes).
Study 2 Main test.............             432               1             432  0.33 (20                  142.56
                                                                                minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................          634.16
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

II. References

    The following references are on display with 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; these are not
available electronically at https://www.regulations.gov as these
references are copyright protected. Some may be available at the
website address, if listed. 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. LaTour, C. and M. Smith, (1986). ``A Study of Expert
Endorsement of OTC Pharmaceutical Products.'' Journal of
Pharmaceutical Marketing & Management, 1(2), pp. 117-128.
    2. Bhutada, N.S. and B.L. Rollins (2015). ``Disease-Specific
Direct-to-Consumer Advertising of Pharmaceuticals: An Examination of
Endorser Type and Gender Effects on Consumers' Attitudes and
Behaviors.'' Research in Social & Administrative Pharmacy, 11(6),
pp. 891-910.
    3. Boerman, S.C., L.M. Willemsen, and E.P. Van Der Aa (2017).
``This post is sponsored' Effects of Sponsorship Disclosure on
Persuasion Knowledge and Electronic Word of Mouth in the Context of
Facebook.'' Journal of Interactive Marketing, 38, pp. 82-92.

    Dated: January 21, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01408 Filed 1-27-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 77 (Tuesday, April 22, 2014)]
[Rules and Regulations]
[Page 22395]
[FR Doc No: 2014-09064]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-0254]

Drawbridge Operation Regulation; Jamaica Bay and Connecting
Waterways, Queens, NY

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Gil Hodges (Marine Parkway) Bridge
across the Jamaica Bay, mile 3.0 at Queens, New York. This temporary
deviation authorizes the bridge to remain in the closed position for
three days to facilitate mechanical repairs at the bridge.

DATES: This deviation is effective from 7 a.m. on April 28, 2014
through 5 p.m. on April 30, 2014.

ADDRESSES: The docket for this deviation [USCG-2014-0254] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140, on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC, 20590, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Ms. Judy Leung-Yee, Project Officer,
First Coast Guard District, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Cheryl Collins, Program Manager, Docket Operations, telephone 202-
366-9826.

SUPPLEMENTARY INFORMATION: The Gil Hodges (Marine Parkway) Bridge
across the Jamaica Bay at mile 3.0, at Queens, New York, has 55 feet of
vertical clearance at mean high water and 59 feet of vertical clearance
at mean low water. The existing drawbridge operation regulations are
listed at 33 CFR 117.795(a).
    The owner of the bridge, MTA Bridges & Tunnels, requested a
temporary deviation from the schedule to facilitate mechanical repairs
at the bridge.
    The waterway has commercial oil barge traffic of various sizes.
    Under this temporary deviation the Gil Hodges (Marine Parkway)
Bridge across Jamaica Bay at mile 3.0, may remain in the closed
position from 7 a.m. on April 28, 2014 through 5 p.m. on April 30,
2014. Vessels that can pass under the bridge without a bridge opening
may do so at all times. There are no alternate routes.
    The Coast Guard contacted the upstream facilities and no objections
were received.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: April 11, 2014.
C.J. Bisignano,
Supervisory Bridge Management Specialist, First Coast Guard District.
[FR Doc. 2014-09064 Filed 4-21-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Page 10116]
[FR Doc No: 2021-03308]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4575-DR; Docket ID FEMA-2021-0001]

Oklahoma; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Oklahoma (FEMA-4575-DR), dated December 21, 2020, and
related determinations.

DATES: This amendment was issued January 13, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Oklahoma is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of December 21, 2020.

    Alfalfa, Blaine, Comanche, Custer, Ellis, Garfield, Grant,
Jackson, Kay, Lincoln, Major, McClain, Pawnee, Stephens, Tillman,
and Washita Counties for Public Assistance.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Robert J. Fenton,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-03308 Filed 2-17-21; 8:45 am]
BILLING CODE 9111-23-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request: Environmental Protection Agency 2. OMB control number b. G None a 2060  0111 3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title NSPS Subpart NN Phosphate Rock Plants 8. Agency form number( s) ( If applicable) ICR # 1078.06 9. Keywords Clear Air Act, Environmental Protection, Air Pollution Control 10. Abstract Owners or operators of phosphate rock plants must make initial notifications and report performance test results. They must also make excess emissions reports, operate continuous monitoring systems, and keep records of certain operational occurrences.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 31 b. Total annual responses 31 1. Percentage of these responses collected electronically 0 % c. Total annual hours requested 3002 d. Current OMB inventory 2445 e. Difference + 557 f. Explanation of difference 1. Program Change 0 2. Adjustment + 557 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs $ 74 b. Total annual costs ( O& M) $ 253 c. Total annualized cost requested $ 327 d. Current OMB inventory $ 256 e. Difference + $ 71 f. Explanation of difference 1. Program change 2. Adjustment + $ 71 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P_ Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. X On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biennually 8. Q Other ( describe)

17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Stephen J. Howie Phone: 202 564 4146 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

( c) Even though the recordkeeping and reporting requirements are the same for small and larger businesses, the Agency considers these requirements the minimum needed to ensure compliance and, therefore, cannot reduce them further for small businesses.

Signature of Program Office Official Rick Colbert, Director Agricultural and Ecosystem Division Office of Compliance ( OECA) Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information ( OEI) Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( i) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( i) the reasons the information is planned to be and/ or has been collected; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

10/ 95


[Federal Register Volume 84, Number 132 (Wednesday, July 10, 2019)]
[Notices]
[Pages 32899-32900]
[FR Doc No: 2019-14648]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER19-2316-000]

Renewable Energy Asset Management Group, LLC; Supplemental Notice
That Initial Market-Based Rate Filing Includes Request for Blanket
Section 204 Authorization

    This is a supplemental notice in the above-referenced Renewable
Energy Asset Management Group, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is July 22, 2019.

    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: July 2, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-14648 Filed 7-9-19; 8:45 am]
 BILLING CODE 6717-01-P