[Federal Register Volume 77, Number 119 (Wednesday, June 20, 2012)]
[Notices]
[Pages 37051-37055]
[FR Doc No: 2012-14989]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0568]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental Study:
Disease Information in Branded Promotional Material

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July
20, 2012.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to

<EMAIL_ADDRESS>All comments should be identified with
the OMB control number 0910-new and title, ``Experimental Study:
Experimental Study: Disease Information in Branded Promotional
Material.'' Also include the FDA docket number found in brackets in the
heading of this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Experimental Study: Disease Information in Branded Promotional
Material--(OMB Control Number 0910-New)

I. Regulatory 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 (the 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.
    FDA regulations require prescription drug advertisements to contain
accurate information about the benefits and risks of the drug
advertised. Generally, the advertising must not be misleading about the
effectiveness of the drug. Specifically, the ad must not contain a
representation or suggestion that the drug is better than has been
shown by substantial evidence or useful in a broader range of patients
(Ref. 1). The regulations prohibit sponsors from, for example,
disseminating promotional information that may broaden the indications
of medications beyond the indication for which they have been approved.
    Rationale: As a public health agency, FDA encourages the
communication of accurate health messages about medical conditions and
treatments. One way in which broad disease information is communicated
to the public is through disease awareness communications.

    Disease awareness communications are communications disseminated
to consumers or health care practitioners that discuss a particular
disease or health condition, but do not mention any specific drug or
device or make any representation or suggestion concerning a
particular drug or device. Help-seeking communications are disease
awareness communications directed at consumers. FDA believes that
disease awareness communications can provide important health
information to consumers and health care practitioners, and can
encourage consumers to seek, and health care practitioners to
provide, appropriate treatment. This is particularly important for
under-diagnosed, under-treated health conditions, such as
depression, hyperlipidemia, hypertension, osteoporosis, and
diabetes. Unlike drug and device promotional labeling and
prescription drug and restricted device advertising, disease
awareness communications are not subject to the requirements of the
Federal Food, Drug, and Cosmetic Act (the act) and FDA
regulations.''(Ref. 2)

    Some research has shown that disease awareness advertising is
viewed by consumers as more informative and containing less persuasive
intent than full product advertising (Ref. 3).
    Sponsors may choose to include disease information in their full
product promotions. Such information is designed to educate the patient
about his or her disease condition. However, in some cases a full
description of the medical condition may include information about
specific health outcomes that are not part of a drug's approved
indication. The current project is designed to determine if providing
such information in branded full product advertisements affects
perceptions of the product.
    When broad disease information accompanies or is included in an ad
for a specific drug, consumers may mistakenly assume that the drug will
address all of the potential consequences of the condition mentioned in
the ad by making inferences that go beyond what is explicitly stated in
an advertisement (Ref. 4). For example, the mention of diabetic
retinopathy in an advertisement for a drug that lowers blood glucose
may lead consumers to infer that the drug will prevent diabetic
retinopathy, even if no direct claim is made. The advertisement may
imply broader indications for the promoted drug than are warranted,
leading consumers to infer effectiveness of the drug beyond the
indication for which it was approved. If consumers are able to
distinguish between disease information and product claims in an ad,
then they will not be misled by the inclusion of disease information in
a branded ad. If consumers are unable to distinguish these two,
however, then consumers may be misled into believing that a particular
drug is effective against long-term consequences. The current study
will explore perceptions that result from including both disease
information and promotional information about a specific drug in the
same advertising piece.
    Design Overview: We will investigate the effects of adding disease
outcome information to branded promotional materials on consumer
perceptions and understanding. This information will be examined in the
context of direct-to-consumer prescription drug print advertisements.
We hope to more readily generalize our findings by exploring the issues
raised in this document in three medical conditions varying in severity
and symptomatology: Chronic obstructive pulmonary disease (COPD),
lymphoma, and anemia.
    We plan to examine two variables in this study: the type of disease
information (possible disease outcomes, versus non-outcome information,
versus no information) and the format of the information (integrated
with drug information versus separated). Some participants will see
information about the disease that avoids discussion of disease
outcomes the drug has not been shown to address, such as, ``Diabetes is
a disease in which blood sugar can vary uncontrollably, leading to
uncomfortable episodes of high or low blood sugar.'' Other participants
will see disease information that mentions consequences of the disease
that go beyond the indication of the advertised product, such as,
``Untreated diabetes can lead to blindness, amputation, and, in some
cases, death.'' A third group will see drug product information only
(no disease information). We will also examine the way in which the
disease information is presented relative to the product claims in the
piece by varying the format: Disease information mixed (integrated)
with product claims versus disease information apart (separated) from
product claims. We are exploring a number of different options for
implementing these two variables. For example: alternating paragraphs
of product and disease information, disease information on one page and
product information on another page, use of different colors and fonts
for disease and product information, and different visuals for disease
and product information. Final format variations will be determined
through pretesting. The pretests are designed only to make sure the
particulars of the main study are implemented in the best way possible.
The results of the pretests will not increase the burden on respondents
in the main study, nor will the main study design change as a result of
the pretests.
    This study utilizes random assignment to conditions. Within

medical condition, participants will be randomly assigned to see one
version of the ad. Participants will be recruited from a general
population sample to control for prior knowledge about disease
outcomes.
    The design is described in Table 1:

                                              Table 1--Study Design
----------------------------------------------------------------------------------------------------------------
                                                               Format of disease and product information
                                Disease information  -----------------------------------------------------------
      Medical condition                 plus                                               Control  (no disease
                                                         Integrated        Separated              info)
----------------------------------------------------------------------------------------------------------------
COPD.........................  Non-outcome..........
                               Outcomes.............
Lymphoma.....................  Non-outcome..........
                               Outcomes.............
Anemia.......................  Non-outcome..........
                               Outcomes.............
----------------------------------------------------------------------------------------------------------------

    Data will be collected using an Internet protocol. Participants
will be recruited from a general population sample to control for prior
knowledge about disease outcomes. Because the task presumes basic
reading abilities, all selected participants must speak and read
English fluently. Participants must be 18 years or older. We will use
ANOVAs and regressions to test hypotheses. Interviews are expected to
last no more than 20 minutes. A total of 4,650 participants will be
involved in the study. This will be a one-time (rather than annual)
collection of information.
    In the Federal Register of August 16, 2011 (76 FR 50737), FDA
published a 60-day notice for public comment on the proposed collection
of information. FDA received one public submission. In the following
section, we outline the observations and suggestions raised in the
submission and provide our responses.
    (Comment 1) One statement suggested we add a multiple choice
question to obtain a baseline of how consumers research information
about their disease in other forms and if they are actively engaged in
health care decisions.
    (Response) We agree this question is interesting, but feel it is
outside the scope of the current study. The purpose of the study is to
examine how disease outcome and product information contained within
the same piece influences perceptions of product benefit.
    (Comment 2) One comment stated that the inclusion of the MedWatch
reporting statement discloses the prescription status of the product
and suggested rewording the question about the type of product being
tested.
    (Response) We have reworded the question, removing the choice
options ``household cleaner'' and ``herbal supplement'' and added a
``don't know'' option.
    (Comment 3) Two statements said that open-ended questions would
result in subjective data interpretation and suggested either replacing
them with closed-ended questions or deleting. These statements also
suggested that procedures for coding, categorizing and analyzing
verbatim responses be established in advance, and that comparable
questions about both benefits and risks be included.
    (Response) We have established baseline codes for the open-ended
questions and included parallel questions to assess perceptions of
benefits and risks (see draft questionnaire). Other codes will be
established through pretesting. We will have two independent raters for
coding and we will calculate inter-rater reliability. Disagreements
between coders will be resolved through discussion. In addition, our
open-ended questions are accompanied by closed-ended questions.
    (Comment 4) One comment stated that those previously diagnosed with
the medical condition may respond differently than the newly diagnosed.
    (Response) We agree that length of diagnosis could impact responses
to information. We are recruiting a general population sample and plan
to use medical condition as a covariate. We have added a question to
assess time since diagnosis among those who self-identify as having the
condition of interest.
    (Comment 5) The submission suggested deleting items: (1) Attitudes
about the product; (2) multiple items measuring the same construct
(risk, benefit); and (3) perceptions of the risk/benefit tradeoff.
    (Response) We have addressed these suggestions in the following
ways. We have deleted the questions measuring product attitudes. We
believe that two questions measuring risk and benefits are necessary to
assess the reliability (Ref. 5) of each construct and so have kept both
questions. With regard to the final point, we agree that the risk/
benefit ratio is different for each patient, but we also think that the
perceived risk/benefit ratio for a product is influenced by the
information presented in the ad. It is relevant here in that the risk/
benefit assessment may be influenced by the perception that the disease
outcome information is a product characteristic.
    (Comment 6) One statement suggested deleting the questions related
to behavioral intention, while another statement suggested expanding
these questions.
    (Response) As these statements are contradictory, we offer our
reasoning behind including these questions. In an ideal situation, we
would be able to measure actual behaviors that may result from exposure
to a particular promotional campaign. Because we cannot do that, we
propose to measure participants' intended behavior; that is, the
likelihood that they would engage in specific outcome behaviors that
may occur as a result of exposure to the product and disease
information. This is in concordance with the recommendations of the
November 17, 2011, meeting of the Risk Communication Advisory
Committee, which suggested behavioral intention as an important
variable to measure in research studies on promotion.
    (Comment 7) One comment stated that the questions assessing recall
included false benefit items but were not balanced with statements to
recall true/factual disease awareness information and suggested
including true statements from the disease awareness information.
    (Response) Our use of the term ``false benefit'' in the
questionnaire notes may have caused confusion. In the draft
questionnaire, ``false benefit'' simply refers to disease
characteristics that are not part of the product's indication. The
purpose of this question is to first

determine which, if any, of the outcome claims are being interpreted by
the participant as product benefits. Following this question is an
open-ended question intended to measure what it was about the ad that
suggested that (see questionnaire). We have revised the questionnaire
notes to read ``outcome'' and ``non-outcome'' for clarity.
    (Comment 8) One statement asked for more detail about the study
design and stimuli layout and offered specific suggestions on variables
to include in the study: Vary the presentation of the disease
information using headers with and without disclaimers, use a control
test ad with no headers, use branded colors, non-branded colors, etc.
to maximize understanding of whether consumers are able to distinguish
between disease information and product claims and whether the format
enhances understanding.
    (Response) We have included a description of the study design in
both the 60-day and 30-day Federal Register notices. We are exploring a
number of different options for implementing the layout of the stimuli.
For example: Alternating paragraphs of product and disease information,
disease information on one page and product information on another
page, use of identical or different colors and fonts for disease and
product information, and different visuals for disease and product
information. Final format variations will be determined through
pretesting. This is the first study of this issue and therefore we are
focusing on a small number of variations. It is not feasible to include
every possible variation. We appreciate the layout suggestions
provided.
    (Comment 9) One statement addressed the recruitment process,
requesting that we disclose how participants will be recruited and
recommending mall intercept recruitment because recruiting participants
online may not be reflective of the consumer likely to observe print
advertising.
    (Response) We plan to recruit and conduct the study online to use
our resources most efficiently.
    (Comment 10) One statement asked for a rationale for our sample
size.
    (Response) We have provided a rationale for our sample size in the
Power Analysis.
    (Comment 11) One statement requested details on the assignment to
conditions, saying it was unclear if the study will include a
sufficiently stratified sample based on language abilities, preexisting
knowledge/disease awareness, age, gender, etc.
    (Response) Participants will be randomly assigned to conditions. An
attempt will be made to have an equal number of males and females in
each experimental cell. Approximately 20 percent of participants in
each cell will have a high school education or less, with a range of
education and race/ethnicity represented in each condition. The
following screening criteria will be employed: participants must be age
18 and over, must not work for a pharmaceutical company, an advertising
agency, a market research company, or be health care professionals.
    (Comment 12) One statement asked that the screener specify if only
those previously diagnosed with the condition will be eligible to
participate, saying those previously diagnosed with the medical
condition may engage differently than those who are recently diagnosed.
    (Response) We agree that those who have the medical condition may
react differently than those who do not. We plan to use diagnosis as a
covariate in our analyses.
    The total annual estimated burden imposed by this collection of
information is 1,873 hours for this one-time collection.
    The response burden chart is listed in table 2.

                                  Table 2--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                                      No. of
            Activity                  No. of       responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses    per response 2
----------------------------------------------------------------------------------------------------------------
Sample outgo (pretests and main           27,679  ..............  ..............  ..............  ..............
 survey)........................
Number of screener completes               9,688               1           9,688            2/60             323
 (35%)..........................
Number eligible (80%)...........           7,750  ..............  ..............  ..............  ..............
Number of completes, Pretests                900               1             900           20/60             300
 (60%)..........................
Number of completes, Study (60%)           3,750               1           3,750           20/60           1,250
Number of pretest/study                    4,650  ..............  ..............  ..............  ..............
 completes......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,873
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
  minutes per response]/60''.

II. References

    The following references have been placed on display in the
Division of Dockets Management, (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and
may be seen by interested persons between 9 a.m. and 4 p.m., Monday
through Friday. (FDA has verified the Web site addresses, but we are
not responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.)

    1. See 21 CFR 202.1(e)(6): ``An advertisement for a prescription
drug is false, lacking in fair balance, or otherwise misleading, or
otherwise violative of section 502(n) of the act, among other
reasons if it: (i) Contains a representation or suggestion, not
approved or permitted for use in the labeling, that a drug is
better, more effective, useful in a broader range of patients (as
used in this section, patients means humans and in the case of
veterinary drugs, other animals), safer, has fewer, or less
incidence of, or less serious side effects or contraindications than
has been demonstrated by substantial evidence or substantial
clinical experience (as described in paragraphs (e)(4)(ii)(b) and
(c) of this section) whether or not such representations are made by
comparison with other drugs or treatments * * *''
    2. Draft Guidance for Industry: `Help-Seeking' and Other Disease
Awareness Communications by or on Behalf of Drug and Device Firms''
(pg. 1). Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070068.pdf.
Last accessed June 8, 2012.
    3. Lee-Wingate, S. and Xie, Y. (2010). Consumer perceptions of
product-claim versus help-seeking direct-to-consumer advertising.
``International Journal of Pharmaceutical and Healthcare
Marketing,'' 4(3), 232-246.
    4. Burke, R. R., DeSarbo, W. S., Oliver, R. L., and Robertson,
T. S. (1988). Deception by implication: An experimental
investigation. ``Journal of Consumer Research,'' 14(4), 483-

494; Harris, R. J. (1977) Comprehension of pragmatic implication in
advertising. ``Journal of Applied Psychology,'' 62, 603-608; Jacoby,
J. and Hoyer, W. (1987). ``The comprehension and miscomprehension of
print communications.'' New York: The Advertising Educational
Foundation.
    5. Guidance for Industry: Patient Reported Outcome Measures: Use
in Medical Product Development to Support Labeling Claims. Available
at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071975.pdf.
Last accessed November 16, 2011.
    6. Transcript available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/UCM283132.pdf. Last accessed
January 4, 2012.

    Dated: June 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14989 Filed 6-19-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 165 (Monday, August 30, 2021)]
[Rules and Regulations]
[Pages 48305-48306]
[FR Doc No: 2021-18643]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0680]
RIN 1625-AA00

Safety Zone; Green River; Drakesboro, KY

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
Green River at MM 99 to 101, on September 22, 2021 in conjunction with
operations being conducted at the Paradise Fossil Plant. This safety
zone is needed to protect the public, vessels, and waterfront
facilities from destruction, loss, or injury from sabotage or other
subversive acts, accidents, or other causes of a similar nature from
the hazards associated with explosive operations at the Paradise Fossil
Plant. Entry into this safety zone is prohibited unless specifically
authorized by the Captain of the Port (COTP) Sector Ohio Valley or a
designated representative.

DATES: This rule is effective without actual notice from 6 a.m. through
9 a.m. on September 22, 2021.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2021-0680 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email MST1 Taylor Mudrock, U.S Coast Guard<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. It is
impracticable to publish an NPRM because this safety zone must be
established by September 22, 2021, and we lack sufficient time to
provide a reasonable comment period and then consider those comments
before issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. For the same reasons discussed in
the preceding paragraph, a 30 day delay of the effective date would be
contrary to public interest because action is needed to respond to the
potential safety hazards associated with the implosion at the Paradise
Fossil Plant involving explosives beginning September 22, 2021.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Sector Ohio
Valley (COTP) has determined that potential safety needs associated
with the explosive operations at the Paradise Fossil Plant on September
22, 2021, present a safety concern. The purpose of this rulemaking is
to ensure the safety of the public surrounding regulated area before,
during, and after the scheduled times.

IV. Discussion of the Rule

    This rule establishes a temporary safety zone from 6 a.m. through 9
a.m. on September 22, 2021. The safety zone will cover all navigable
waters from mile 99 to 101 on the Green River. The duration of the zone
is intended to protect personnel and vessels in and around these
navigable waters during the explosive operations at the Paradise Fossil
Plant before, during, and after the scheduled times. No vessel or
person will be permitted to enter the safety zone without obtaining
permission from the COTP or a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the regulated area. This rule is
limited to the Green River from mile 99 to 101 on September 22, 2021
and will be enforced only during the times specified. Moreover, the
Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine
channel 16 about the regulated area and the rule allows vessels to seek
permission to enter the

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.

    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does 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.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves
establishing a temporary safety zone on the Green River at mile 99 to
101 on September 22, 2021. It is categorically excluded from further
review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction
Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration
supporting this determination is available in the docket. For
instructions on locating the docket, see the ADDRESSES section of this
preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1., Revision No. 01.2.

0
2. Add Sec.  165.T08-0451 to read as follows:

Sec.  165.T08-0451   Safety Zone; Green River, Drakesboro, KY.

    (a) Location. The following area is a safety zone: All navigable
waters of the Green River between MM 99 to MM 101 in Drakesboro, KY.
    (b) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by VHF-FM radio channel 16 or phone at 1-800-253-7465.
Those in the safety zone must comply with all lawful orders or
directions given to them by the COTP or the COTP's designated
representative.
    (c) Enforcement period. This section will be enforced from 6 a.m.
through 9 a.m. on September 22, 2021.

    Dated: August 24, 2021.
A.M. Beach,
Captain, U.S. Coast Guard, Captain of the Port Sector Ohio Valley.
[FR Doc. 2021-18643 Filed 8-27-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Notices]
[Pages 3839-3841]
[FR Doc No: 2018-01365]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82550; File No. SR-Phlx-2018-03]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Add a New Rule
3215 and Commentary Thereto To Codify PSX Participant Risk Settings in
PSX and To Authorize the Exchange To Share Those Settings With the
Clearing Member That Clears Transactions on Behalf of the PSX
Participant

January 19, 2018.
    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 January 16, 2018, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to add a new Rule 3215 and commentary thereto
to codify PSX Participant risk settings in PSX and to authorize the
Exchange to share those settings with the clearing member that clears
transactions on behalf of the PSX Participant.
    The text of the proposed rule change is set forth below. Proposed
new language is italicized; deleted text is in brackets.
* * * * *

Nasdaq PHLX Rules

Rules of the Exchange

* * * * *

Nasdaq PSX

* * * * *

[Rule 3215. Reserved.]

Rule 3215. Exchange Sharing of PSX Participant Risk Settings

    The Exchange may share any PSX Participant risk settings in the
trading system specified in the commentary below with the clearing
member that clears transactions on behalf of the PSX Participant. For
purposes of this Rule, the term ``PSX Participant'' has the meaning set
forth in Rule 3301(c).

Commentary

    The Exchange offers certain risk settings applicable to a PSX
Participant's activities on the Exchange. The risk settings currently
offered by the Exchange are:
    (a) Share Size Control--When enabled by a PSX Participant, this
optional control will allow a PSX Participant to limit the number of
shares that the PSX Participant may associate with an order placed on
the Exchange;
    (b) ISO Control--When enabled by a PSX Participant, this optional
control will prevent a PSX Participant from entering an ISO order onto
the Exchange;
    (c) Cancel-on-Disconnect Control--When enabled by a PSX
Participant, this optional control will allow a PSX Participant, when
it experiences a disruption in its connection to the Exchange, to
immediately cancel all pending Exchange orders except for Good-Till-
Canceled orders (RASH & FIX only);
    (d) The Phlx Kill Switch--This control is described in Rule 3316;
    (e) Limit Order Protection--This control is described in Rule
3307(f);
    (f) Price Collar Check--This control will automatically restrict a
routed order from executing at a price that differs from the NBBO (at
the time of order entry) by more than five percent or $0.25, whichever
difference is greater. The system will proceed to route an order unless
and until it crosses the greater of these two price collars, and if it
does so, then the system will block further routings of the order that
fall outside of the collars. For example, if the NBBO is $99 x $100 at
the time of entry of a buy order, then the system will route the order
at prices at or below $105, but will stop doing so if the offer price
rises above $105 (five percent of the NBO);
    (g) Maximum Order Volume Check--This control will automatically
reject an order for routing away that exceeds a maximum volume of
shares. As applied to equity orders, the default maximum order volume
is set at 25,000 shares, but the PSX Participant may request that the
Exchange set a higher default based on historic volume;
    (h) Cumulative Order Volume Check--This control will automatically
block an attempt by a PSX Participant using a particular MPID to route
orders away to buy or sell equity securities that, cumulatively, exceed
9.5 million shares during a five second time period; and
    (i) Duplication Control--This control will automatically reject an
order that a PSX Participant submits to the Exchange to the extent that
it is duplicative of another order that the PSX Participant submitted
to the Exchange during the prior five seconds.
* * * * *

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

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

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

1. Purpose
    The Exchange proposes to adopt the proposed commentary to Rule
3215, which codifies a comprehensive list of PSX Participant risk
settings in the Exchange's trading system. The Exchange also proposes
to adopt new Rule 3215 to authorize the Exchange to share these risk
settings with the clearing member that clears transactions on behalf of
the PSX Participant. For purposes of Rule 3215, the term ``PSX
Participant'' has the meaning set forth in Rule 3301(c).\3\
---------------------------------------------------------------------------

    \3\ Rule 3301(c) defines a ``PSX Participant'' as an entity that
fulfills the obligations contained in Rule 3211 regarding
participation in the System, and includes Equities ECNs, PSX Market
Makers, and Order Entry Firms.
---------------------------------------------------------------------------

    PSX Participants are required to be members of the Exchange. Rule
3218 states that ``all transactions through the facilities of PSX shall
be cleared and settled through a registered clearing agency using a
continuous net settlement system.'' It further provides that this
requirement may be satisfied by ``direct participation, use of direct
clearing services, by entry into a correspondent clearing arrangement
with another member organization that clears trades through such a
clearing agency. . ..'' Further, pursuant to Rule 3227, every clearing
member acting on a PSX Participant's behalf that constitutes a side of
a system trade is responsible for honoring such trades of that PSX
Participant.
    All PSX Participants that are not clearing members require a
clearing

member's consent to clear transactions on their behalf in order to
conduct business on the Exchange. Each PSX Participant that transacts
through a clearing member on the Exchange must have an arrangement
between the PSX Participant and the clearing member. The Exchange is
provided notice of which clearing members have relationships with which
PSX Participants. The clearing member that guarantees the PSX
Participant's transactions on the Exchange has a financial interest in
understanding the risk tolerance of the PSX Participant. The proposal
would provide the Exchange with authority to directly provide clearing
members with information that may otherwise be available to such
clearing members by virtue of their relationship with the respective
PSX Participants.
    The proposed commentary to Rule 3215 would codify a list of risk
settings that are currently offered by the Exchange and would be
covered by proposed Rule 3215. This list is comprehensive with respect
to the risk settings that the Exchange presently offers. Certain of
these risk settings are mandatory for PSX Participants, meaning that
the Exchange either imposes specific risk tolerances that are uniform
for all PSX Participants or it sets default risk tolerances, but it
affords flexibility to PSX Participants to select their own risk
tolerance levels. In certain instances, the Exchange does not require
PSX Participants to utilize risk settings, but instead makes them
available for use at the option of PSX Participants. The risk settings
set forth in the proposed commentary to Rule 3215 comprise the
following:
     Share Size Control--When enabled by a PSX Participant,
this optional control will allow a PSX Participant to limit the number
of shares that the PSX Participant may associate with an order placed
on the Exchange;
     ISO Control--When enabled by a PSX Participant, this
optional control will prevent a PSX Participant from entering an ISO
order onto the Exchange;
     Cancel-on-Disconnect Control--When enabled by a PSX
Participant, this optional control will allow a PSX Participant, when
it experiences a disruption in its connection to the Exchange, to
immediately cancel all pending Exchange orders except for Good-Till-
Canceled orders (RASH & FIX only);
     The Phlx Kill Switch--This control is described in Rule
3316;
     Limit Order Protection--This control is described in Rule
3307(f);
     Price Collar Check--This control will automatically
restrict a routed order from executing at a price that differs from the
NBBO (at the time of order entry) by more than five percent or $0.25,
whichever difference is greater. The system will proceed to route an
order unless and until it crosses the greater of these two price
collars, and if it does so, then the system will block further routings
of the order that fall outside of the collars. For example, if the NBBO
is $99 x $100 at the time of entry of a buy order, then the system will
route the order at prices at or below $105, but will stop doing so if
the offer price rises above $105 (five percent of the NBO).
     Maximum Order Volume Check--This control will
automatically reject an order for routing away that exceeds a maximum
volume of shares. As applied to equity orders, the default maximum
order volume is set at 25,000 shares, but the PSX Participant may
request that the Exchange set a higher default based on historic
volume.
     Cumulative Order Volume Check--This control will
automatically block an attempt by a PSX Participant using a particular
MPID to route orders away to buy or sell equity securities that,
cumulatively, exceed 9.5 million shares during a five second time
period; and
     Duplication Control--This control will automatically
reject an order that a PSX Participant submits to the Exchange to the
extent that it is duplicative of another order that the PSX Participant
submitted to the Exchange during the prior five seconds.
    As set forth above, the proposal to authorize the Exchange to share
any of the PSX Participant's risk settings with the clearing member
that clears transactions on behalf of the PSX Participant would be
limited to the risk settings specified in the proposed commentary. The
Exchange notes that use by a PSX Participant of the risk settings
offered by the Exchange is optional for share size, ISO, kill switch,
and cancel-on disconnect controls, and is required in other
instances.\4\ By using the optional risk settings, following this
proposed Rule change a PSX Participant therefore also opts-in to the
Exchange sharing its risk settings with its clearing member. The
Exchange notes that any PSX Participant that does not wish to share its
mandatory risk settings with its clearing member could avoid sharing
such settings by becoming a clearing member.
---------------------------------------------------------------------------

    \4\ As noted above, for the Maximum Order Volume Check, the
Exchange sets a default order volume but PSX Participants have
flexibility to adjust this level.
---------------------------------------------------------------------------

    To the extent that a clearing member might reasonably require a PSX
Participant to provide access to its risk settings as a prerequisite to
continuing to clear trades on the PSX Participant's behalf, the
Exchange's proposal to share those risk settings directly reduces the
administrative burden on PSX Participants and ensures that clearing
members are receiving information that is up-to-date and conforms to
the settings active in the Exchange's trading system. Further, the
Exchange believes that the proposal will help such clearing members to
better monitor and manage the potential risks that they assume when
clearing for PSX Participants of the Exchange.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\5\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\6\ in particular, in that it is designed 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 transactions
in securities, 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.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The proposed rule change will allow the Exchange to directly
provide a PSX Participant's risk settings to the clearing member that
clears trades on behalf of the PSX Participant. A clearing member
guarantees transactions executed on PSX for members with whom it has
entered into a clearing arrangement, and therefore bears the risk
associated with those transactions. The Exchange believes that it is
appropriate for the clearing member to have knowledge of what risk
settings the PSX Participant may utilize within the Exchange's trading
system. The proposal will permit clearing members who have a financial
interest in the risk settings of PSX Participants with whom the PSX
Participants have entered into clearing arrangements to better monitor
and manage the potential risks assumed by clearing members, thereby
providing clearing members with greater control and flexibility over
setting their own risk tolerance and exposure and aiding clearing
members in complying with the Act. To the extent a clearing member
might reasonably require a PSX

Participant to provide access to its risk settings as a prerequisite to
continuing to clear trades on the PSX Participant's behalf, the
Exchange's proposal to share those risk settings directly reduces the
administrative burden on PSX Participants and ensures that clearing
members are receiving information that is up-to-date and conforms to
the settings active in the Exchange's trading system. Moreover, the
proposal will foster cooperation and coordination with persons engaged
in facilitating transactions in securities and more generally, will
protect investors and the public interest, by reducing administrative
burden on both clearing members and other PSX Participants and by
allowing clearing members to better monitor their risk exposure.
    The Exchange further believes that codifying the risk settings
described above in the proposed commentary is consistent with the Act.
These settings assist PSX Participants in managing and controlling the
risks associated with their access to and activity on the Exchange,
both for the benefit of PSX Participants and investors. The Exchange's
risk settings, moreover, are consistent with risk settings employed by
other exchanges, such as Cboe BYX. Although the Exchange presently
offers these risk settings, codifying them will provide additional
transparency to PSX Participants regarding the risk settings offered by
the Exchange. It will also foster cooperation and coordination with
persons engaged in facilitating transactions in securities and more
generally, will protect investors and the public interest, by providing
additional transparency regarding risk settings offered by the
Exchange.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act, as amended. The proposed
rule change is not designed to address any competitive issues and does
not pose an undue burden on non-clearing members because, unlike
clearing members, non-clearing members do not guarantee the execution
of a Participant's transactions on the Exchange. Moreover, the proposal
to share risk settings with clearing members will not burden
competition among clearing members because it will apply to all
clearing members equally and regardless of size. The Exchange notes
that this proposal will not affect competition among PSX Participants
because the proposal provides for sharing of all of PSX Participants'
risk settings set forth in the commentary to Rule 3215. Any PSX
Participant that does not wish to share its risk settings with its
clearing member could avoid sharing such settings by becoming a
clearing member. Lastly, the proposal to codify the Exchange's risk
settings will not burden competition among PSX Participants because the
risk settings are already available to or required of PSX Participants
and will continue to be available or required of all PSX Participants
going forward.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \7\ and Rule 19b-
4(f)(6) thereunder.\8\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-Phlx-2018-03 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2018-03. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (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 website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-Phlx-2018-03 and should be submitted on
or before February 16, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-01365 Filed 1-25-18; 8:45 am]
 BILLING CODE 8011-01-P


1 OCPSF Detailed Study Plan  Revised December 29, 2003 ORGANIC CHEMICALS, PLASTICS, AND SYNTHETIC FIBERS ( OCPSF) DETAILED STUDY PLAN December 29, 2003 General Steps 1. Gather Information ° Industry demographics ( profiles) ° Identify pollutants of concern and product/ process sources ° Identify focus industries ° Baseline pollutant loads for focus industries ° Applicable control technologies for focus industries ( includes wastewater treatment and pollution reduction alternatives)

2. Develop Model Facilities and Scale Up Procedures 3. Develop Control Options ° Estimate costs  Capital and operating costs  Regulatory costs ° Estimate pollutant reductions 4. Prepare Report and Documentation 1. Gather Information Information Needs ° Identify focus industries: those which generate wastewater containing the pollutants of concern ( aniline, benzo( a) pyrene, benzo( b) fluoranthene, benzo( a) anthracene, dioxin and dioxin like compounds, polycyclic aromatic compounds, and sodium nitrite); ° For the focus industries, identify the number of OCPSF facilities by product type ( use http:// www. census. gov/ prod/ ec97/ 97m3251d. pdf); and ° Identify pollution reduction technologies, their costs, and pollutant reduction potential for focus industry wastestreams.

Industry Profile and Identification of Pollutants of Concern ° Review NPDES permits and fact sheets from states, EPA regions, and on line sources. 2 OCPSF Detailed Study Plan  Revised December 29, 2003 ° Continue contacting select sites to determine if the processes generating certain pollutants ( e. g. dioxin) fall within the scope of the OCPSF Category and to confirm assumptions regarding TRI reporting.

Questions to address:

° Which facilities fall in the focus industries? How many facilities are in each industry in the 1997 U. S. Census? Do they report to TRI? If yes, how many are direct, indirect, or zero discharge?

° What are the reported discharges to TRI and PCS, in pounds per year and toxic weighted pound equivalents ( TWPE) per year for 2000?

° Are the TWPE mostly from directs or indirects?

° What is the TWPE discharged per facility?

° Are production data available?

Baseline Pollutant Loads ° Revise baseline loads and assumptions used for the first analysis based on additional information for the focus industries.

° Sort out the toxic weighted pounds for sites that are not representative of typical OCPSF sites and consider them separately from the OCPSF total ( e. g., dioxins from Dow Chemical in Freeport, Texas and Dow Chemical in Plaquemine, Louisiana).

° Sort out the toxic weighted pounds from sites when the process generating the pollutant is not regulated by OCPSF and consider them in the proper point source category ( e. g., dioxins from chlor alkali producers).

° Use data from the Chlorine Chemistry Council ( http:// www. c3. org) and the Vinyl Institute on dioxin for the EDC/ VCM/ PVC manufacturers.

° Use available site specific data on polycyclic aromatic compounds to better characterize the specific chemicals discharged and then apply a more industryspecific toxic weighting factor to TRI data for discharges from coal tar refiners.

° Use the background documents to the Dyes and/ or Pigment Production Wastes Hazardous Waste Proposed Rule dated November 25, 2003 to better characterize wastewater discharges from dye manufacturers. 3 OCPSF Detailed Study Plan  Revised December 29, 2003 ° Identify additional data sources to better characterize wastewater discharges from dye manufacturers.

Questions to address:

° What pollutants are discharged and how much ( base year is 2000)?

° How can the pollutant loadings be scaled to the whole focus industry?

° Where do the discharged pollutants come from ( i. e., is there a process/ product combination of the focus industry that is responsible for the certain high toxic loads, such as diazo dye manufacturing)?

Applicable Control Technology ° Identify pollution prevention and treatment technologies. Use data from EPA's Office of Pollution Prevention and Toxics ( OPPT) to identify potential process changes, feedstock replacements, or other means of pollution prevention. Identify any treatment technologies that can be added to the current treatment in place. Perform a literature search and talk to treatment technology vendors.

° Target technologies that will reduce toxic loads. Evaluate the cost per pound of toxic load removed.

° One candidate add on end of pipe technology is granulated activated carbon ( GAC). Use data from vendors and/ or previous effluent guidelines for cost and performance data.

° Identify the treatment in place at manufacturers of diazo dyes reporting aniline discharges to TRI.

° Identify any additional control technologies that can be applied to other OCPSF focus industries. Perform a literature search and talk with treatment control technology vendors.

Questions to address:

° What pollution prevention and treatment technologies can be applied to the focus industry?

° What pollutants ( in addition to the pollutants of concern) will these technologies help control? 4 OCPSF Detailed Study Plan  Revised December 29, 2003 2. Develop Model OCPSF Sites and Scale up Procedures ° Identify representative discharging facilities from each focus industry and gather all available data.

° Develop " model sites" based on the representative facilities.

° Develop a scheme to scale up models to full industry ( i. e., develop the weights or scale up factors that will be applied to each model).

° To the extent possible validate the model. This may be limited to pollutant discharges ( e. g., do baseline model discharges, extrapolated by scale up procedure, result in the total reported discharges from PCS2000 and the 2000 TRI?).

° Search for literature ( e. g., from vendors) or case studies for potential use in validating model costs.

3. Develop Control Options Including Estimating Costs and Pollutant Reductions ° Identify feasible pollution reduction technologies. Investigate:

Whether any of the focus industries do not have biological treatment in place. For example, if dye manufacturers do not have biological treatment, evaluate if adding it would be cost effective.

Process changes that will eliminate or reduce:

S wastewater discharge volume; or S amount of pollutants discharged to wastewater ( recycle and/ or reuse of feedstock).

Granular activated carbon as an add on technology for end of pipe or inprocess wastestream.

° Collect capital and operating cost and performance information for relevant model site applications. Also collect information on monitoring and reporting requirements. Data sources include previous effluent guidelines, literature reviews, and contacting equipment vendors ( get prices for sizes that reflect the model sites).

° Estimate costs and pollutant reductions achievable by implementing the control options at each model site and scale up to estimate the costs and reductions 5 OCPSF Detailed Study Plan  Revised December 29, 2003 achievable for the entire industry. Format of output must be useable by economists for analyzing economic impact and cost effectiveness.

° Consider nonwater quality impacts, particularly air emissions and Resource Conservation and Recovery Act ( RCRA) hazardous waste regulations ( i. e., would any of the residues created by wastewater treatment be hazardous wastes?). Note: Some wastes from azo dye production ( e. g. aniline distillation bottoms) are listed hazardous wastes.

Questions to address:

° Are there control technologies used by the industry in addition to biological treatment for control of organic pollutants?

° Do dye manufacturers use biological treatment?

° Should other technologies be applied to the industry to control discharge of organics ( e. g., GAC)? What will they cost?

° Do publicly owned treatment works ( POTWs) adequately treat wastewater from indirect dischargers ( i. e., control discharge of toxic organics and color)?

° How much will implementing these solutions reduce pollutant discharges from direct and indirect dischargers? Eliminate technologies that have high costs and low pollutant removal from further analysis.

4. Prepare Report and Documentation Draft study report will include:

° Industry profile; ° Rationale for selection of focus industries; ° Baseline pollutant loads ( including TWPE); ° Descriptions of pollution control options; ° Costs & removals for each analyzed option; ° Documentation of the methodology used to estimate costs and pollutant reductions; and ° Discussion of the quality of the data used for these estimates, including " data gaps."


[Federal Register Volume 85, Number 113 (Thursday, June 11, 2020)]
[Notices]
[Pages 35650-35652]
[FR Doc No: 2020-12635]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC20-71-000.
    Applicants: GenOn California South, LP, Ormond Beach Power, LLC,
Ellwod Power, LLC.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act, et al. of GenOn California South, LP, et al.
    Filed Date: 6/5/20.
    Accession Number: 20200605-5175.
    Comments Due: 5 p.m. ET 6/26/20.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG20-180-000.
    Applicants: Assembly Solar I, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Assembly Solar I, LLC.
    Filed Date: 6/4/20.
    Accession Number: 20200604-5156.
    Comments Due: 5 p.m. ET 6/25/20.

    Docket Numbers: EG20-181-000.
    Applicants: American Electric Power Service Corporation.
    Description: Clyde OnSite Generation, LLC Notice of Self-
Certification of Exempt Wholesale Generator Status.
    Filed Date: 6/5/20.
    Accession Number: 20200605-5121.
    Comments Due: 5 p.m. ET 6/26/20.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2390-005; ER19-784-001; ER10-2394-006; ER12-
1563-006; ER10-2395-006; ER10-2422-007; ER12-1562-006; ER11-3642-019.

    Applicants: Bicent (California) Malburg LLC, Big Country Datalec
LLC, BIV Generation Company, L.L.C., Cayuga Operating Company, LLC,
Colorado Power Partners, Rocky Mountain Power, LLC, Somerset Operating
Company LLC, Tanner Street Generation, LLC.
    Description: Supplement to February 5, 2020 Notice of Non-Material
Change in Status of Bicent (California) Malburg LLC, et. al.
    Filed Date: 6/5/20.
    Accession Number: 20200605-5077.
    Comments Due: 5 p.m. ET 6/26/20.

    Docket Numbers: ER19-211-002.
    Applicants: Entergy Arkansas, LLC, Entergy Louisiana, LLC, Entergy
Mississippi, LLC, Entergy New Orleans, LLC, Entergy Texas, Inc.,
Entergy Arkansas, Inc.
    Description: Compliance filing: TCCs JOOA eTariff Compliance to be
effective 4/30/2020.
    Filed Date: 6/5/20.
    Accession Number: 20200605-5050.
    Comments Due: 5 p.m. ET 6/26/20.

    Docket Numbers: ER19-1916-003.
    Applicants: Louisville Gas and Electric Company.
    Description: Compliance filing: Order 845 and 845-A Amended
Compliance Filing to be effective 5/22/2019.
    Filed Date: 6/5/20.
    Accession Number: 20200605-5031.
    Comments Due: 5 p.m. ET 6/26/20.

    Docket Numbers: ER20-1736-001.
    Applicants: Versant Power.
    Description: Compliance filing: Changes to Attachment J--Formula
Rates (Amended ER20-1736) per Order No. 864 to be effective 6/1/2020.
    Filed Date: 6/5/20.
    Accession Number: 20200605-5011.
    Comments Due: 5 p.m. ET 6/26/20.

    Docket Numbers: ER20-1992-000.
    Applicants: Public Service Company of New Mexico.
    Description: Compliance filing: Order No. 864 Compliance Filing to
be effective 1/27/2020.
    Filed Date: 6/4/20.
    Accession Number: 20200604-5130.
    Comments Due: 5 p.m. ET 6/25/20.

    Docket Numbers: ER20-1993-000.
    Applicants: Duke Energy Progress, LLC.
    Description: Sec.  205(d) Rate Filing: DEP--French Broad EMC--
Wholesale Contract Revisions to Rate Schedule No. 210 to be effective
6/1/2020.
    Filed Date: 6/4/20.
    Accession Number: 20200604-5145.
    Comments Due: 5 p.m. ET 6/25/20.

    Docket Numbers: ER20-1994-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to ISA, Service
Agreement No. 4123, Non-Queue #NQ115 to be effective 6/2/2015.
    Filed Date: 6/5/20.
    Accession Number: 20200605-5021.
    Comments Due: 5 p.m. ET 6/26/20.

    Docket Numbers: ER20-1995-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2020-06-05_SA 3364 NIPSCO-
Indiana Crossroads Wind Farm 1st Rev GIA (J837 J838) to be effective 5/
21/2020.
    Filed Date: 6/5/20.
    Accession Number: 20200605-5032.
    Comments Due: 5 p.m. ET 6/26/20.

    Docket Numbers: ER20-1996-000.
    Applicants: Assembly Solar I, LLC.
    Description: Baseline eTariff Filing: Baseline New to be effective
8/5/2020.
    Filed Date: 6/5/20.
    Accession Number: 20200605-5039.
    Comments Due: 5 p.m. ET 6/26/20.

    Docket Numbers: ER20-1997-000.
    Applicants: Cheyenne Light, Fuel and Power Company.
    Description: Compliance filing: Order No. 864 Compliance Filing to
be effective 1/27/2020.
    Filed Date: 6/5/20.
    Accession Number: 20200605-5048.
    Comments Due: 5 p.m. ET 6/26/20.

    Docket Numbers: ER20-1998-000.
    Applicants: Assembly Solar I, LLC.
    Description: Sec.  205(d) Rate Filing: COC filing to be effective
8/5/2020.
    Filed Date: 6/5/20.
    Accession Number: 20200605-5056.
    Comments Due: 5 p.m. ET 6/26/20.

    Docket Numbers: ER20-1999-000.
    Applicants: Duke Energy Progress, LLC.
    Description: Sec.  205(d) Rate Filing: DEP-Haywood Wholesale
Contract Revisions to Rate Schedule No. 180 to be effective 6/1/2020.
    Filed Date: 6/5/20.
    Accession Number: 20200605-5068.
    Comments Due: 5 p.m. ET 6/26/20.

    Docket Numbers: ER20-2000-000.
    Applicants: Clyde Onsite Generation, LLC.
    Description: Baseline eTariff Filing: MBR Authority Application to
be effective 7/1/2020.
    Filed Date: 6/5/20.
    Accession Number: 20200605-5089.
    Comments Due: 5 p.m. ET 6/26/20.

    Docket Numbers: ER20-2001-000.
    Applicants: ISO New England Inc.
    Description: Informational Filing Regarding Additional Conditions
to applicant for participation in the New England Markets of ISO New
England Inc.
    Filed Date: 6/5/20.
    Accession Number: 20200605-5147.
    Comments Due: 5 p.m. ET 6/26/20.

    Docket Numbers: ER20-2002-000.
    Applicants: Mid-Atlantic Interstate Transmission, LLC, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: MAIT submits ECSA No. 5881
to be effective 8/4/2020.
    Filed Date: 6/5/20.
    Accession Number: 20200605-5156.
    Comments Due: 5 p.m. ET 6/26/20.

    Docket Numbers: ER20-2003-000.
    Applicants: American Transmission Systems, Incorporated, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: ATSI submits ECSA No. 5882
to be effective 8/4/2020.
    Filed Date: 6/5/20.
    Accession Number: 20200605-5163.
    Comments Due: 5 p.m. ET 6/26/20.

    Docket Numbers: ER20-2004-000.
    Applicants: Public Service Electric and Gas Company, PJM
Interconnection, L.L.C.
    Description: Compliance filing: PSEG submits Revisions to PJM
Tariff, Att. H-10 re: Order 864 to be effective 1/27/2020.
    Filed Date: 6/5/20.
    Accession Number: 20200605-5179.
    Comments Due: 5 p.m. ET 6/26/20.

    Docket Numbers: ER20-2005-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2020-06-05_Intermittent
Deliverable ICAP Filing to be effective 8/19/2020.
    Filed Date: 6/5/20.
    Accession Number: 20200605-5189.
    Comments Due: 5 p.m. ET 6/26/20.

    Docket Numbers: ER20-2006-000.
    Applicants: Duke Energy Progress, LLC.
    Description: Sec.  205(d) Rate Filing: DEP-Camden Wholesale
Contract Revisions to Rate Schedule No. 197 to be effective 6/1/2020.
    Filed Date: 6/5/20.
    Accession Number: 20200605-5196.
    Comments Due: 5 p.m. ET 6/26/20.

    Docket Numbers: ER20-2007-000.
    Applicants: San Diego Gas & Electric Company.
    Description: Sec.  205(d) Rate Filing: Black Start 2nd Amended and
Restated Agreement to be effective 8/4/2020.
    Filed Date: 6/5/20.
    Accession Number: 20200605-5202.
    Comments Due: 5 p.m. ET 6/26/20.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings

must file in accordance with Rules 211 and 214 of the Commission's
Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern
time on the specified comment date. Protests may be considered, but
intervention is necessary to become a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 5, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-12635 Filed 6-10-20; 8:45 am]
BILLING CODE 6717-01-P