[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Notices]
[Pages 20148-20151]
[FR Doc No: 2019-09418]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3138]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental Study of
an Accelerated Approval Disclosure

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 (PRA).

DATES: Fax written comments on the collection of information by June 7,
2019.

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

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>
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 of an Accelerated Approval Disclosure

OMB Control Number 0910-NEW

I. Background

    Section 1701(a)(4) of the Public Health Service Act (PHS 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 mission of the Office of Prescription Drug Promotion (OPDP) is
to protect the public health by helping to ensure that prescription
drug information is truthful, balanced, and accurately communicated so
that patients and healthcare providers can make informed decisions
about treatment options. The OPDP's research program supports this
mission by providing 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 we believe 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 falls under the topic of advertising features (content and
format).
    Pursuant to section 506(c) of the FD&C Act (21 U.S.C. 356(c)) and
21 CFR part 314, subpart H (or 21 CFR part 601, subpart E for
biological products), FDA may grant accelerated approval to a drug
product under section 505(c) of the FD&C Act (21 U.S.C. 355(c)) or a
biological product under section 351(a) of the PHS Act (42 U.S.C
262(a)). This pathway enables faster approval of prescription drugs
intended to treat serious or life-threatening illnesses. Accelerated
approval may be based on a determination that a drug product has an
effect on a surrogate endpoint (for example, a blood test result) that
is reasonably likely to predict clinical benefit, or on a clinical
endpoint that can be measured earlier than irreversible morbidity or
mortality, that is reasonably likely to predict an effect on
irreversible morbidity or mortality or other clinical benefit (i.e., an
intermediate clinical endpoint). In approving a drug under the
accelerated approval pathway, the severity, rarity, or prevalence of a
condition, and the availability or lack of alternative treatments, are
taken into account.
    The accelerated approval pathway is limited to certain products
intended to treat serious or life-threatening illnesses as there can be
``[u]ncertainty about whether clinical benefit will be verified and the
possibility of undiscovered risks'' (FDA 2014 guidance for industry
entitled ``Expedited Programs for Serious Conditions--Drugs and
Biologics,'' available at https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf).
Sponsors are generally required to conduct post approval studies to
verify and describe the predicted clinical benefit, but those
confirmatory studies are not complete at the time that the accelerated
approval is granted (Ref. 1). In the event that the required post
approval confirmatory studies fail to verify and describe the predicted
effect or clinical benefit, a drug's approval can be withdrawn using
expedited procedures.
    Under FDA's regulations governing physician labeling for
prescription drugs, the INDICATIONS AND USAGE section of the FDA-
approved prescribing information (PI) for a drug approved under
accelerated approval must include a succinct description of the
limitations of usefulness of the drug and any uncertainty about
anticipated clinical benefits, with reference to the clinical studies
section for a discussion of the available evidence (21 CFR

201.57(c)(2)(i)(B)). Therefore, the PI for accelerated approval
products typically satisfies this requirement by including a statement
in the INDICATIONS AND USAGE section about the product's approval under
the accelerated approval pathway. In a guidance, FDA recommended that
the INDICATIONS AND USAGE section for drugs approved under accelerated
approval should generally describe three elements: indication(s),
limitations of usefulness and clinical benefit uncertainty, and
continued approval (``Labeling for Human Prescription Drug and
Biological Products Approved Under the Accelerated Approval Pathway''
(January 2019). Available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM390058.pdf.). As
the PI is intended for healthcare professionals, the information
related to a drug's accelerated approval generally includes complex
concepts and sophisticated wording. For example, PIs for accelerated
approval products include language such as:
     This indication is approved under accelerated approval
based on [surrogate endpoint]. An improvement in survival or disease-
related symptoms has not been established. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in the confirmatory trial; or
     Approval is based on a reduction in [surrogate endpoint].
There are no controlled trials demonstrating a direct treatment benefit
such as improvement in disease-related symptoms, functioning, or
increased survival.
    Despite its complexity, sponsors often use this language from the
PI in direct-to-consumer (DTC) promotional materials for drugs approved
under accelerated approval. In other cases, DTC promotion of
accelerated approval products does not communicate the unique
considerations and potential limitations inherent in the accelerated
approval process.
    Disclosures may be used to communicate information such as this to
consumers. Disclosures can include information about scientific and
clinical data, any residual uncertainty about clinical benefit, and the
practical utility of scientific and clinical data. These disclosures
may influence consumer comprehension and affect perception of drug
risks and benefits. This study will examine the presence, wording, and
prominence of a disclosure communicating information related to the
drug's accelerated approval in DTC promotional materials. This
information includes the use of surrogate or intermediate clinical
endpoints to support approval, the uncertainty about the relationship
of the surrogate or intermediate clinical endpoint to the predicted
clinical benefit, and the need for confirmatory trials.
    We plan to conduct one pretest not longer than 20 minutes,
administered via internet panel, to test the experimental manipulations
and pilot the main study procedures. After implementing any lessons
learned from the pilot, we plan to conduct one main study not longer
than 20 minutes, administered via internet panel. For the pretest and
main study, we will randomly assign the participants to one of the test
conditions (see table 1 for the study design). We have chosen to focus
on oncology products because cancer is a life-threatening illness, and
many oncology products are granted accelerated approval. Moreover, DTC
promotion of oncology drugs is common. In the study, participants will
view a website for a fictional oncology prescription drug. After
viewing the website, participants will complete a questionnaire that
assesses whether participants noticed the disclosure and their
interpretation of it, as well as perceptions of the drug's risks and
benefits. We will also measure covariates such as demographics and
literacy. The questionnaire is available upon request from
<EMAIL_ADDRESS>    We will vary the presence and prominence of the disclosure (e.g.,
size, color, and location). We hypothesize that participants will be
more likely to notice the disclosure when it is presented more, rather
than less, prominently. In turn, we expect that participants'
perceptions of the drug are more likely to be affected by the
disclosure in the high prominence condition. We also will vary whether
the disclosure is written in consumer-friendly language or uses
language, in use by many sponsors, which is the same as or similar to
that directed at healthcare professionals in FDA-approved prescription
drug labeling for accelerated approval products. The consumer-friendly
version of the accelerated approval disclosure will be based on
consumer feedback elicited in focus groups conducted prior to the
pretest (approved under OMB control number 0910-0695). The physician
labeling version of the accelerated approval disclosure will be drawn
from FDA-approved physician labeling. We hypothesize that participants
will be more likely to notice and understand the disclosure and use it
to form their perceptions of the drug if they view the consumer-
friendly language. To test these hypotheses, we will conduct
inferential statistical tests such as logistic regression and analysis
of variance.

                                              Table 1--Study Design
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                                                                       High
                                                                    prominence    Low prominence      Absent
----------------------------------------------------------------------------------------------------------------
Physician Labeling version......................................
Consumer-friendly version.......................................
----------------------------------------------------------------------------------------------------------------

    We will recruit a general population sample of adult volunteers 18
years of age or older. We will exclude individuals who work for the
U.S. Department of Health and Human Services or work in the healthcare,
marketing, advertising, or pharmaceutical industries. We will use
health literacy quotas to ensure that our sample includes participants
with a range of health literacy skills. With the sample sizes described
below, we will have sufficient power to detect small-sized effects in
the main study (table 2).
    In the Federal Register of October 17, 2018 (83 FR 52478), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received four submissions that were PRA-
related. Within those submissions, FDA received multiple comments,
which the Agency has addressed below.
    (Comment 1) One comment suggested that the study does not evaluate
the extent to which patients understand accelerated approval,
``including the serious and life-threatening nature of the disease, the
fact that FDA determined that the product is likely to provide a
meaningful advantage over available therapy, the fact that the

product likely addresses a significant unmet medical need, and that the
accelerated approval has yet to be confirmed with additional data.''
The comment suggests updating Q12, Q13, and Q18 to reflect this
context.
    (Response) We will begin the study by giving participants
information about acute lymphoblastic leukemia, which includes its
serious and life-threatening nature, to put the accelerated approval of
the drug product in the appropriate context. Questions 3-9 assess
participants' understanding of the accelerated approval concepts
conveyed in the disclosure. The concepts in the disclosure align with
the elements recommended by FDA to describe accelerated approval
products and information currently seen in DTC promotion (Ref. 2).
Questions 12, 13, and 18 are designed to measure participants'
perceptions of the drug's risks.
    (Comment 2) One comment suggested that the proposed disclosure
language, ``we currently do not know if Drug X helps people live longer
or feel better'' should be replaced with ``we currently do not know if
Drug X helps to minimize progression of disease and improve quality of
life.'' The comment noted that the proposed language may be simplistic
and inaccurate because ``feel better'' is subjective and may be
irrelevant for cancer treatments.
    (Response) In many cases, the available data for accelerated
approval products do provide information about disease progression,
without providing information on overall survival (i.e., living
longer). Therefore, we do not believe that replacing ``live longer''
with ``minimizing progression of disease'' makes the disclosure more
accurate or consumer-friendly. In addition, based on our focus group
testing, we believe that ``feel better'' is a consumer-friendly way to
discuss improvements in symptoms or quality of life. We disagree that
this is an irrelevant outcome for cancer patients.
    (Comment 3) One comment stated that Q26 (Perspective Taking Scale)
does not appear necessary.
    (Response) We included the Perspective Taking Scale as a potential
moderator. Participants will be drawn from the general public, and we
will ask them to imagine that someone close to them was recently
diagnosed with the relevant medical condition. Participants' ability to
identify with a different perspective might affect how well they are
able to do this. We will evaluate the usefulness of this measure in the
pretest and drop it from the main study if it does not apply.
    (Comment 4) One comment recommended studying another consumer-
friendly disclosure in place of the physician labeling version of the
disclosure. In addition, this comment recommended that the consumer-
friendly disclosure not mention unknown outcomes (i.e., ``we currently
do not know if Drug X helps people live longer or feel better.'').
    (Response) We plan to study the physician labeling version of the
disclosure because sponsors currently use this language to explain
accelerated approval in DTC promotion (Ref. 2). We plan to include a
statement about unknown outcomes in the disclosure because it is one of
the elements recommended by FDA to describe accelerated approval
products, and it is present in currently used accelerated approval
disclosures (Ref. 2). We are in support of additional research that
would study alternate consumer-friendly versions.
    (Comment 5) One comment requested clarification on the execution of
the prominence conditions, in particular regarding its proximity to the
indication.
    (Response) The disclosure will be presented in direct conjunction
with the indication in both prominence conditions. In the high
prominence condition, the disclosure will also be presented along with
the largest claim.
    (Comment 6) Three comments requested access to the study stimuli.
    (Response) We have described the purpose of the study, the design,
the population of interest, and have provided the questionnaire to
numerous individuals upon request. We provided the disclosure language
in the questionnaire. Our full stimuli are under development during the
PRA process. We do not make draft stimuli public during this time
because of concerns that this may contaminate our participant pool and
compromise the research.
    (Comment 7) One comment requested that we clarify the primary
measure of the study.
    (Response) Our hypotheses are based on noticing the disclosure
(Q20), understanding the disclosure (Q3-Q9), and perceptions (Q10-Q17).
    (Comment 8) One comment asked why items Q20 and Q21 come after
items Q7-Q19.
    (Response) Items Q7-Q19 are designed to measure participants'
reaction to the experimental condition to which they were assigned.
Items Q20 and Q21 show the disclosure to all participants (regardless
of experimental condition) and ask them to respond to it.
    (Comment 9) One comment questioned the utility of Q19-B.
    (Response) We agree with this concern and have deleted this item.
    (Comment 10) One comment stated a concern that an accelerated
approval disclosure could cause undue apprehension and deter people who
might otherwise benefit from seeking treatment advice about accelerated
approval products. Based on this concern, the comment suggested adding
questions about whether participants would seek information regarding
potential risks or discuss the accelerated approval status with a
healthcare professional.
    (Response) The current study is intended to gather data that will
help us understand how accelerated approval disclosures may impact
consumer perception of an accelerated approval drug product. In a
content analysis of accelerated approval product websites, we found
that 73 percent currently include some form of a disclosure already
(Ref. 2). Therefore, it is important to study what effect these
disclosures may have. We will measure participants' perceptions of the
drug's benefits and risks. In addition, we have expanded our intention
question to also measure intentions to suggest a loved one ask their
doctor about the drug's risks, benefits, and FDA approval.
    (Comment 11) One comment suggested that promotional materials are
not the best venue for providing information about prescription drugs,
given the role of healthcare professionals in discussing and
prescribing treatments. Based on this, the comment suggested modifying
the study to focus on prescriber-patient interactions rather than DTC
promotion.
    (Response) Consumers often wish to participate in shared decision-
making with healthcare professionals when selecting prescription drugs
and may request specific prescription drugs from their healthcare
professionals based on promotions they have seen in the marketplace.
Because information consumers receive through DTC prescription drug
promotion can impact these requests, it is important to investigate how
the information in prescription drug promotional pieces impacts
consumer attention, understanding, and perceptions.
    (Comment 12) One comment noted that, in real-world conditions,
consumers do not choose an accelerated approval product in a vacuum.
This comment requested that we provide participants with information on
the limited availability and/or effectiveness of alternative
treatments.

    (Response) We acknowledge that accelerated approval products often
constitute the only treatment option or one of a limited number of
treatment options available to patients. We revised the questionnaire
to include information for participants in this study about the
treatment landscape for the disease.
    (Comment 13) One comment recommends enrolling a diversity of
participants across demographic categories and geographic locations.
They suggest screening for pretest participants, individuals who have
recently participated in prescription drug research, and individuals
with prior use of oncology products or accelerated approval products.
    (Response) Participants will be internet panel members. We will use
soft quotas to ensure recruitment of a low health literacy population
as well as a demographically diverse set of participants. Pretest
participants will not be allowed to participate in the main study. We
added questionnaire items asking participants whether they have been
diagnosed with cancer, and if so whether they have ever taken
prescription drugs, and specifically accelerated approval products, for
cancer.
    (Comment 14) One comment noted that participants may pay more
attention to information presented in a study, including claims
designed to be intentionally misleading, and asked what efforts we will
take to avoid response bias.
    (Response) The study design does not include intentionally
misleading claims. Based on previous research with DTC prescription
drug websites, we expect the median time spent on the study stimuli to
be under a minute to 2 minutes (Ref. 3). In general, we attempt to
minimize response bias by following best practices, such as keeping the
survey length short and cognitive-testing and pretesting the questions
to make sure they are clearly written.
    (Comment 15) One comment requested that the screener and consent
form be made available.
    (Response) The screener and consent form are available as part of
the information collection submission to the OMB.
    (Comment 16) One comment noted that the wording of Q4 and Q9 could
lead participants toward a specific response.
    (Response) These questions are designed to measure whether
participants processed the information in the disclosure. Thus, Q4 asks
about the unknown outcome information from the disclosure, and Q9 asks
about the continuing research information from the disclosure. Because
these are not meant to be questions about perceptions, we have changed
the wording of Q4 to clarify that we are asking about what the website
said, rather than what they might think. We will evaluate these items
in cognitive interview and pretesting.
    (Comment 17) One comment recommended adding intermediate response
values for Q10-Q17 and Q24-Q26.
    (Response) We have added intermediate response values for these
items, with the exception of Q26, the Perspective Taking Scale, to be
consistent with its previous use.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 2--Estimated Annual Reporting Burden \1\
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                                                                   No. of
                   Activity                        No. of       responses per   Total annual          Average burden per response           Total Hours
                                                 respondents     respondent       responses
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Pretest screener.............................             916               1               1  0.08 (5 minutes).........................           73.28
Study screener...............................           1,507               1               1  0.08 (5 minutes).........................          120.56
Pretest......................................             385               1               1  0.33 (20 minutes)........................          127.05
Main Study...................................             633               1               1  0.33 (20 minutes)........................          208.89
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................          529.78
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\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 (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; 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. Beaver J.A., L.J. Howie, L. Pelosof, et al., ``A 25-Year
Experience of U.S. Food and Drug Administration Accelerated Approval
of Malignant Hematology and Oncology Drugs and Biologics: A
Review.'' JAMA Oncology, 4(6):849-856, 2018. doi:10.1001/
jamaoncol.2017.5618.
2. Sullivan H.W., A.C. O'Donoghue, K.T. David, et al., ``Disclosing
Accelerated Approval on Direct-to-Consumer Prescription Drug
websites.'' Pharmacoepidemiology and Drug Safety, 27:1277-1280,
2018. https://doi.org/10.1002/pds.4664.
3. Sullivan H.W., A.C. O'Donoghue, D.J. Rupert, et al., ``Placement
and Format of Risk Information on Direct-to-Consumer Prescription
Drug Websites.'' Journal of Health Communication, 22:171-181, 2017.

    Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09418 Filed 5-7-19; 8:45 am]
 BILLING CODE 4164-01-P


t Washington Generating Station 4040 1 ARP ARP ARP ARP ARP WI Port Washington Generating Station 4040 2 ARP ARP ARP ARP ARP WI Port Washington Generating Station 4040 3 ARP ARP ARP ARP ARP WI Port Washington Generating Station 4040 4 ARP ARP ARP WI Pulliam 4072 3 ARP ARP ARP ARP ARP WI Pulliam 4072 4 ARP ARP ARP ARP ARP WI Pulliam 4072 5 ARP ARP ARP ARP ARP WI Pulliam 4072 6 ARP ARP ARP ARP ARP WI Pulliam 4072 7 ARP ARP ARP ARP ARP WI Pulliam 4072 8 ARP ARP ARP ARP ARP WI ROCK RIVER 4057 5 EIA EIA EIA EIA EIA WI ROCK RIVER 4057 6 EIA EIA EIA EIA EIA WI ROCK RIVER 4057 3 EIA EIA EIA EIA EIA WI Rock River 4057 1 ARP ARP ARP ARP ARP WI Rock River 4057 2 ARP ARP ARP ARP ARP WI Sheepskin 4059 1 EIA EIA EIA EIA WI South Fond Du Lac 7203 ** CT1 ARP ARP ARP ARP ARP WI South Fond Du Lac 7203 ** CT2 ARP ARP ARP ARP ARP Annual Unit NOx Allocation July 7, 2006 WI South Fond Du Lac 7203 ** CT3 ARP ARP ARP ARP ARP WI South Fond Du Lac 7203 ** CT4 ARP ARP ARP ARP ARP WI South Oak Creek 4041 5 ARP ARP ARP ARP ARP WI South Oak Creek 4041 6 ARP ARP ARP ARP ARP WI South Oak Creek 4041 7 ARP ARP ARP ARP ARP WI South Oak Creek 4041 8 ARP ARP ARP ARP ARP WI Stoneman 4146 B1 ARP ARP ARP ARP ARP WI Stoneman 4146 B2 ARP ARP ARP ARP ARP WI Valley ( WEPCO) 4042 1 ARP ARP ARP ARP ARP WI Valley ( WEPCO) 4042 2 ARP ARP ARP ARP ARP WI Valley ( WEPCO) 4042 3 ARP ARP ARP ARP ARP WI Valley ( WEPCO) 4042 4 ARP ARP ARP ARP ARP WI WEST MARINETTE 4076 31 EIA EIA EIA EIA WI WEST MARINETTE 4076 32 EIA EIA EIA EIA WI West Marinette 4076 ** 33 ARP ARP ARP ARP ARP WI West Marinette 4076 ** 34 ARP ARP ARP ARP ARP WI Weston 4078 1 ARP ARP ARP ARP ARP WI Weston 4078 2 ARP ARP ARP ARP ARP WI Weston 4078 3 ARP ARP ARP ARP ARP WI WESTON GENERATING ST 4078 32 EIA EIA EIA EIA EIA WI Wheaton 4014 4 EIA EIA EIA EIA EIA WI Wheaton 4014 5 EIA EIA EIA EIA EIA WI Wheaton 4014 6 EIA EIA EIA EIA EIA WI Wheaton 4014 2 EIA EIA EIA EIA EIA WI Wheaton 4014 1 EIA EIA EIA EIA EIA WI Wheaton 4014 3 EIA EIA EIA EIA EIA WI Whitewater Cogeneration Facility 55011 01 ARP ARP ARP ARP ARP WV Albright Power Station 3942 1 ARP ARP ARP ARP ARP WV Albright Power Station 3942 2 ARP ARP ARP ARP ARP WV Albright Power Station 3942 3 ARP ARP ARP ARP ARP WV Fort Martin Power Station 3943 1 ARP ARP ARP ARP ARP WV Fort Martin Power Station 3943 2 ARP ARP ARP ARP ARP WV Grant Town Power Plant 10151 1A 10151 BLR1A EIA EIA EIA EIA EIA WV Grant Town Power Plant 10151 1B 10151 BLR1B EIA EIA EIA EIA EIA WV Harrison Power Station 3944 1 ARP ARP ARP ARP ARP WV Harrison Power Station 3944 2 ARP ARP ARP ARP ARP WV Harrison Power Station 3944 3 ARP ARP ARP ARP ARP WV John E Amos 3935 1 ARP ARP ARP ARP ARP WV John E Amos 3935 2 ARP ARP ARP ARP ARP WV John E Amos 3935 3 ARP ARP ARP ARP ARP WV Kammer 3947 1 ARP ARP ARP ARP ARP WV Kammer 3947 2 ARP ARP ARP ARP ARP Annual Unit NOx Allocation July 7, 2006 WV Kammer 3947 3 ARP ARP ARP ARP ARP WV Kanawha River 3936 1 ARP ARP ARP ARP ARP WV Kanawha River 3936 2 ARP ARP ARP ARP ARP WV Mitchell ( WV) 3948 1 ARP ARP ARP ARP ARP WV Mitchell ( WV) 3948 2 ARP ARP ARP ARP ARP WV Morgantown Energy Facility 10743 CFB1 10743 CFB1 EIA EIA EIA EIA EIA WV Morgantown Energy Facility 10743 CFB2 10743 CFB2 EIA EIA EIA EIA EIA WV Mount Storm Power Station 3954 1 ARP ARP ARP ARP ARP WV Mount Storm Power Station 3954 2 ARP ARP ARP ARP ARP WV Mount Storm Power Station 3954 3 ARP ARP ARP ARP ARP WV Mountaineer ( 1301) 6264 1 ARP ARP ARP ARP ARP WV North Branch Power Station 7537 1A ARP ARP ARP ARP ARP WV North Branch Power Station 7537 1B ARP ARP ARP ARP ARP WV Phil Sporn 3938 11 ARP ARP ARP ARP ARP WV Phil Sporn 3938 21 ARP ARP ARP ARP ARP WV Phil Sporn 3938 31 ARP ARP ARP ARP ARP WV Phil Sporn 3938 41 ARP ARP ARP ARP ARP WV Phil Sporn 3938 51 ARP ARP ARP ARP ARP WV Pleasants Power Station 6004 1 ARP ARP ARP ARP ARP WV Pleasants Power Station 6004 2 ARP ARP ARP ARP ARP WV Rivesville Power Station 3945 7 ARP ARP ARP ARP ARP WV Rivesville Power Station 3945 8 ARP ARP ARP ARP ARP WV Willow Island Power Station 3946 1 ARP ARP ARP ARP ARP WV Willow Island Power Station 3946 2 ARP ARP ARP ARP ARP Annual Unit NOx Allocation July 7, 2006 RETIREMENT YEAR 2000 ADJUSTED HEAT INPUT ( mmBtu) 2001 ADJUSTED HEAT INPUT ( mmBtu) 2002 ADJUSTED HEAT INPUT ( mmBtu) 2003 ADJUSTED HEAT INPUT ( mmBtu) 2004 ADJUSTED HEAT INPUT ( mmBtu) AVERAGE HI OVER 3 HIGHEST YEARS STATE TOTAL HI UNIT FRACTION OF STATE TOTAL HI EXISTING UNIT STATE NOX BUDGET ( 95% OF TOTAL TONS) UNIT NOX ANNUAL ALLOCATION ( tons)


[Federal Register Volume 76, Number 183 (Wednesday, September 21, 2011)]
[Notices]
[Pages 58492-58493]
[FR Doc No: 2011-24271]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-RCRA-2011-0751, FRL-9468-8]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Final Authorization for Hazardous Waste Management
Programs

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to the Office of Management and Budget (OMB) to renew
an existing approved Information Collection Request (ICR) concerning
final authorization for State Hazardous Waste Management Programs. This
ICR is scheduled to expire on February 29, 2012. Before submitting the
ICR to OMB for review and approval, EPA is soliciting comments on
specific aspects of the proposed information collection as described
below.

DATES: Comments must be submitted on or before November 21, 2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
RCRA-2011-0751, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: RCRA Docket (28221T), U.S. Environmental Protection
Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460.
     Hand Delivery: 1301 Constitution Ave., NW., Room 3334,
Washington, DC 20460. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-RCRA-
2011-0751. 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 information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. 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. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Peggy Vyas, (mail code 5303P),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number: 703-
308-8433; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

How can I access the docket and/or submit comments?

    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-RCRA-2011-0751, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the RCRA Docket in
the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from
8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
The telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for RCRA Docket is<PHONE_NUMBER>.
    Use http://www.regulations.gov to obtain a copy of the draft
collection of information, submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the public docket that are available electronically. Once
in the system, select ``search,'' then key in the docket ID number
identified in this document.

What information is EPA particularly interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    (i) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility;
    (ii) Evaluate the accuracy of the Agency's estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
    (iii) Enhance the quality, utility, and clarity of the information
to be collected; and
    (iv) Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

What should I consider when I prepare my comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.

    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

What information collection activity or ICR does this apply to?

    Affected entities: Entities potentially affected by this action are
States.
    Title: Final Authorization for Hazardous Waste Management Programs.
    ICR numbers: EPA ICR No. 0969.09, OMB Control No. 2050-0041.
    ICR status: This ICR is currently scheduled to expire on February
29, 2012. An 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. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: In order for a State to obtain final authorization for a
State hazardous waste program or to revise its previously authorized
program, it must submit an official application to the EPA Regional
office for approval. The purpose of the application is to enable EPA to
properly determine whether the State's program meets the requirements
of Sec.  3006 of RCRA. A State with an approved program may voluntarily
transfer program responsibilities to EPA by notifying EPA of the
proposed transfer, as required by section 271.23. Further, EPA may
withdraw a State's authorized program under section 271.23.
    State program revision may be necessary when the controlling
Federal or State statutory or regulatory authority is modified or
supplemented. In the event that the State is revising its program by
adopting new Federal requirements, the State shall prepare and submit
modified revisions of the program description, Attorney General's
statement, Memorandum of Agreement, or such other documents as EPA
determines to be necessary. The State shall inform EPA of any proposed
modifications to its basic statutory or regulatory authority in
accordance with section 271.21. If a State is proposing to transfer all
or any part of any program from the approved State agency to any other
agency, it must notify EPA in accordance with section 271.21 and submit
revised organizational charts as required under section 271.6, in
accordance with section 271.21. These paperwork requirements are
mandatory under Sec.  3006(a). EPA will use the information submitted
by the State in order to determine whether the State's program meets
the statutory and regulatory requirements for authorization.
    Burden Statement: For a State developing and revising a base
program under RCRA and conducting public participation activities, EPA
estimates that the reporting burden, with no associated recordkeeping
burden, averages 0 hours per respondent. EPA does not expect any States
to develop a program application or to submit a base program
application over the three year period covered in this ICR. The
reporting burden includes the time for developing each program
component, allowing for public approval, and subsequently modifying and
submitting the program to EPA. For a State submitting a revised program
to EPA, the reporting burden is estimated to be 1009 hours per year,
with no associated recordkeeping burden. For a State whose program is
being withdrawn, the reporting burden is estimated to average 207
hours, with no associated recordkeeping burden. EPA, however, does not
expect that any State program will be withdrawn during the next three
years.
    Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements
which have subsequently changed; train personnel to be able to respond
to a collection of information; search data sources; complete and
review the collection of information; and transmit or otherwise
disclose the information.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
    Estimated total number of potential respondents: 58.
    Frequency of response: Annual.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 19,968 hours.
    Estimated total annual costs: $658,454, which includes $658,454
annualized labor costs and $0 annualized capital or O&M costs.

What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will
issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: September 14, 2011.
Suzanne Rudzinski,
Director, Office of Resource Conservation and Recovery.
[FR Doc. 2011-24271 Filed 9-20-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 134 (Friday, July 14, 2017)]
[Proposed Rules]
[Pages 32511-32512]
[FR Doc No: 2017-14770]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Chapter I

46 CFR Chapters I and III

49 CFR Chapter IV

[Docket No. USCG-2017-0661]

Merchant Marine Personnel Advisory Committee--Input To Support
Regulatory Reform of Coast Guard Regulations--New Task

AGENCY: U.S. Coast Guard, Department of Homeland Security.

ACTION: Announcement of new task assignment for the Merchant Marine
Personnel Advisory Committee (MERPAC); teleconference meeting.

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SUMMARY: The U.S. Coast Guard is issuing a new task to the Merchant
Marine Personnel Advisory Committee (MERPAC). The U.S. Coast Guard is
asking MERPAC to help the agency identify existing regulations,
guidance, and collections of information (that fall within the scope of
the Committee's charter) for possible repeal, replacement, or
modification. This tasking is in response to the issuance of Executive
Orders 13771, ``Reducing Regulation and Controlling Regulatory Costs;
13777, ``Enforcing the Regulatory Reform Agenda;'' and 13783,
``Promoting Energy Independence and Economic Growth.'' The full
Committee is scheduled to meet by teleconference on August 8, 2017 to
discuss this tasking. This teleconference will be open to the public.
The U.S. Coast Guard will consider MERPAC recommendations as part of
the process of identifying regulations, guidance, and collections of
information to be repealed, replaced, or modified pursuant to the three
Executive Orders discussed above.

DATES: The full Committee is scheduled to meet by teleconference on
August 8, 2017, from 3 p.m. to 4 p.m. EDT. Please note that this
teleconference may adjourn early if the Committee has completed its
business.

ADDRESSES: To join the teleconference or to request special
accommodations, contact the individual listed in the FOR FURTHER
INFORMATION CONTACT section no later than 1 p.m. on August 1, 2017. The
number of teleconference lines is limited and will be available on a
first-come, first-served basis.
    Instructions: Submit comments on the task statement at any time,
including orally at the teleconference, but if you want Committee
members to review your comments before the teleconference, please
submit your comments no later than August 1, 2017. You must include the
words ``Department of Homeland Security'' and the docket number for
this action. Written comments may also be submitted using the Federal
e-Rulemaking Portal at http://www.regulations.gov. If you encounter
technical difficulties with comment submission, contact the individual
listed in the FOR FURTHER INFORMATION CONTACT section of this notice.
Comments received will be posted without alteration at http://www.regulations.gov, including any personal information provided. You
may review Regulations.gov's Privacy

and Security Notice at https://www.regulations.gov/privacyNotice.
    Docket Search: For access to the docket or to read documents or
comments related to this notice, go to http://www.regulations.gov,
insert ``USCG-2017-0661'' in the Search box, press Enter, and then
click on the item you wish to view.

FOR FURTHER INFORMATION CONTACT: Lieutenant Junior Grade James Fortin,
Alternate Designated Federal Officer of the Merchant Marine Personnel
Advisory Committee,<PHONE_NUMBER>, or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

New Task to the Committee

    The U.S. Coast Guard is issuing a new task to MERPAC to provide
recommendations on whether existing regulations, guidance, and
information collections (that fall within the scope of the Committee's
charter) should be repealed, replaced, or modified. MERPAC will then
provide advice and recommendations on the assigned task and submit a
final recommendation report to the U.S. Coast Guard.

Background

    On January 30, 2017, President Trump issued Executive Order 13771,
``Reducing Regulation and Controlling Regulatory Costs.'' Under that
Executive Order, for every one new regulation issued, at least two
prior regulations must be identified for elimination, and the cost of
planned regulations must be prudently managed and controlled through a
budgeting process. On February 24, 2017, the President issued Executive
Order 13777, ``Enforcing the Regulatory Reform Agenda.'' That Executive
Order directs agencies to take specific steps to identify and alleviate
unnecessary regulatory burdens placed on the American people. On March
28, 2017, the President issued Executive Order 13783, ``Promoting
Energy Independence and Economic Growth.'' Executive Order 13783
promotes the clean and safe development of our Nation's vast energy
resources, while at the same time avoiding agency actions that
unnecessarily encumber energy production.
    When implementing the regulatory offsets required by Executive
Order 13771, each agency head is directed to prioritize, to the extent
permitted by law, those regulations that the agency's Regulatory Reform
Task Force identifies as outdated, unnecessary, or ineffective in
accordance with Executive Order 13777. As part of this process to
comply with all three Executive Orders, the U.S. Coast Guard is
reaching out through multiple avenues to interested individuals to
gather their input about what regulations, guidance, and information
collections, they believe may need to be repealed, replaced, or
modified. On June 8, 2017, the U.S. Coast Guard issued a general notice
in the Federal Register requesting comments from interested individuals
regarding their recommendations, 82 FR 26632. In addition to this
general solicitation, the U.S. Coast Guard also wants to leverage the
expertise of its Federal Advisory Committees and is issuing similar
tasks to each of its Committees. A detailed discussion of each of the
Executive orders and information on where U.S. Coast Guard regulations,
guidance, and information collections are found is in the June 8th
notice.

The Task

    MERPAC is tasked to:

    Provide input to the U.S. Coast Guard on all existing
regulations, guidance, and information collections that fall within
the scope of the Committee's charter.
    1. One or more subcommittees/working groups, as needed, will be
established to work on this tasking in accordance with the Committee
charter and bylaws. The subcommittee(s) shall terminate upon the
approval and submission of a final recommendation to the U.S. Coast
Guard from the parent Committee.
    2. Review regulations, guidance, and information collections and
provide recommendations whether an existing rule, guidance, or
information collection should be repealed, replaced or modified. If
the Committee recommends modification, please provide specific
recommendations for how the regulation, guidance, or information
collection should be modified. Recommendations should include an
explanation on how and to what extent repeal, replacement or
modification will reduce costs or burdens to industry and the extent
to which risks to health or safety would likely increase.
    a. Identify regulations, guidance, or information collections
that potentially impose the following types of burden on the
industry:
    i. Regulations, guidance, or information collections imposing
administrative burdens on the industry.
    ii. Regulations, guidance, or information collections imposing
burdens in the development or use of domestically produced energy
resources. ``Burden,'' for the purposes of compliance with Executive
Order 13783, means ``to unnecessarily obstruct, delay, curtail, or
otherwise impose significant costs on the siting, permitting,
production, utilization, transmission, or delivery of energy
resources.''
    b. Identify regulations, guidance, or information collections
that potentially impose the following types of costs on the
industry:
    i. Regulations, guidance, or information collections imposing
costs that are outdated (such as due to technological advancement),
or are no longer necessary.
    ii. Regulations, guidance, or information collections imposing
costs which are no longer enforced as written or which are
ineffective.
    iii. Regulations, guidance, or information collections imposing
costs tied to reporting or recordkeeping requirements that impose
burdens that exceed benefits. Explain why the reporting or
recordkeeping requirement is overly burdensome, unnecessary, or how
it could be modified.
    c. Identify regulations, guidance, and information collections
that the Committee believes have led to the elimination of jobs or
inhibits job creation within a particular industry.
    3. All regulations, guidance, and information collections, or
parts thereof, recommended by the Committee should be described in
sufficient detail (by section, paragraph, sentence, clause, etc.) so
that it can readily be identified. Data (quantitative or
qualitative) should be provided to support and illustrate the
impact, cost, or burden, as applicable, for each recommendation. If
the data is not readily available, the Committee should include
information as to how such information can be obtained either by the
Committee or directly by the Coast Guard.

Public Participation

    All meetings associated with this tasking, both full Committee
meetings and subcommittee/working groups, are open to the public. A
public oral comment period will be held during the August 8, 2017,
teleconference. Public comments or questions will be taken at the
discretion of the Designated Federal Officer; commenters are requested
to limit their comments to 3 minutes. Please contact the individual
listed in the FOR FURTHER INFORMATION CONTACT section, to register as a
commenter. Subcommittee meetings held in association with this tasking
will be announced as they are scheduled through notices posted to
<EMAIL_ADDRESS>and uploaded as supporting documents in
the electronic docket for this action, [USCG-2017-0661], at
Regulations.gov.

J.G. Lantz,
Director of Commercial Regulations and Standards.
[FR Doc. 2017-14770 Filed 7-13-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 111 (Monday, June 10, 2013)]
[Rules and Regulations]
[Pages 34573-34575]
[FR Doc No: 2013-13667]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Parts 100 and 165

[Docket No. USCG-2008-0384]

Special Local Regulations; Safety Zones; Recurring Events in
Captain of the Port Long Island Sound Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce seventeen annual fireworks
display safety zones and one regatta event special local regulation in
the Sector Long Island Sound area of responsibility on various dates
and times listed in the tables below. This action is necessary to
provide for the safety of life on navigable waterways during these
fireworks displays and regatta event. During the enforcement period, no
person or vessel may enter the safety zone without permission of the
Captain of the Port (COTP) Sector Long Island Sound or designated
representative.

DATES: The regulations in 33 CFR 100.100 and 33 CFR 165.151 will be
enforced between June 9, 2013 and September 1, 2013.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Petty Officer Scott Baumgartner, Waterways Management
Division, U.S. Coast Guard Sector Long Island Sound; telephone 203-468-
4559, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the special
local regulation listed 33 CFR 100.100 and safety zones listed in 33
CFR 165.151 on the specified dates and times as indicated in the tables
below. If the event is delayed by inclement weather, the regulation
will be enforced on the rain date indicated in the tables. These
regulations were published in the Federal Register on February 10, 2012
(77 FR 6954).

                         Table to Sec.   100.100
------------------------------------------------------------------------

------------------------------------------------------------------------
1.1 Harvard-Yale Regatta,       Event type: Boat Race.
 Thames River, New London, CT.
                                Date: Sunday, June 9, 2013 from
                                8:15 a.m. until 5:15 p.m.
                                Rain Date: Monday, June 10, 2013
                                from 8:15 a.m. until 12:15 p.m.
                                Location: All waters of the
                                Thames River at New London, Connecticut,
                                between the Penn Central Draw Bridge
                                41[deg]21'46.94'' N 072[deg]05'14.46'' W
                                to Bartlett Cove 41[deg]25'35.90'' N
                                072[deg]5'42.89'' W (NAD 83).
------------------------------------------------------------------------

                        Table 1 to Sec.   165.151
------------------------------------------------------------------------

------------------------------------------------------------------------
6.1 Barnum Festival Fireworks   Date: June 28, 2013.
                                Rain date: June 29, 2013.
                                Time: 9 p.m. to 10:30 p.m.
                                Location: Waters of Bridgeport
                                Harbor, Bridgeport, CT in approximate
                                position 41[deg]9'04'' N,
                                073[deg]12'49'' W (NAD 83).

6.2 Town of Branford            Date: June 22, 2013.
 Fireworks.
                                Rain date: June 23, 2013.
                                Time: 9 p.m. to 10:30 p.m.
                                Location: Waters of Branford
                                Harbor, Branford, CT in approximate
                                position, 41[deg]15'30'' N,
                                072[deg]49'22'' W (NAD 83).
7.1 Point O'Woods Fire          Date: July 4, 2013.
 Company Summer Fireworks.
                                Rain date: July 5, 2013.
                                Time: 9 p.m. to 10:30 p.m.
                                Location: Waters of the Great
                                South Bay, Point O'Woods, NY in
                                approximate position 40[deg]39'18.57''
                                N, 073[deg]08'05.73'' W (NAD 83).
7.4 Norwalk Fireworks........   Date: July 3, 2013.
                                Rain date: July 5, 2013.
                                Time: 8:30 p.m. to 10:30 p.m.
                                Location: Waters off Calf
                                Pasture Beach, Norwalk, CT in
                                approximate position, 41[deg]04'50'' N,
                                073[deg]23'22'' W (NAD 83).
7.5 Lawrence Beach Club         Date: July 3, 2013.
 Fireworks.
                                Rain date: July 5, 2013.
                                Time: 9 p.m. to 10:30 p.m.
                                Location: Waters of the Atlantic
                                Ocean off Lawrence Beach Club, Atlantic
                                Beach, NY in approximate position
                                40[deg]34'42.65'' N, 073[deg]42'56.02''
                                W (NAD 83).
7.6 Sag Harbor Fireworks.....   Date: July 6, 2013.
                                Rain date: July 7, 2013.
                                Time: 9 p.m. to 10:30 p.m.
                                Location: Waters of Sag Harbor
                                Bay off Havens Beach, Sag Harbor, NY in
                                approximate position 41[deg]00'26'' N,
                                072[deg]17'09'' W (NAD 83).
7.7 South Hampton Fresh Air     Date: July 5, 2013.
 Home Fireworks.
                                Rain date: July 7, 2013.
                                Time: 8:45 p.m. to 10:00 p.m.
                                Location: Waters of Shinnecock
                                bay, Southampton, NY in approximate
                                positions, 40[deg]51'48'' N,
                                072[deg]26'30'' W (NAD 83).
7.8 Westport Police Athletic    Date: July 3, 2013.
 league Fireworks.
                                Rain date: July 5, 2013.
                                Time: 8:30 p.m. to 10:00 p.m.
                                Location: Waters off Compo
                                Beach, Westport, CT in approximate
                                position, 41[deg]06'15'' N,
                                073[deg]20'57'' W (NAD 83).
7.11 City of Norwich July       Date: July 5, 2013.
 Fireworks.
                                Rain date: July 6, 2013.
                                Time: 9 p.m. to 10:30 p.m.
                                Location: Waters of the Thames
                                River, Norwich, CT in approximate
                                position, 41[deg]31'16.84'' N,
                                072[deg]04'43.33'' W (NAD 83).
7.22 Mason's Island Yacht       Date: July 6, 2013.
 Club Fireworks.
                                Rain date: July 7, 2013.
                                Time: 8:30 p.m. to 10:00 p.m.
                                Location: Waters of Fisher's
                                Island Sound, Noank, CT in approximate
                                position 41[deg]19'30.61'' N,
                                071[deg]57'48.22'' W (NAD 83).
7.24 Riverfest Fireworks.....   Date: July 6, 2013.
                                Rain date: July 7, 2013.
                                Time: 8 p.m. to 11:00 p.m.
                                Location: Waters of the
                                Connecticut River, Hartford, CT in
                                approximate positions, 41[deg]45'39.93''
                                N, 072[deg]39'49.14'' W (NAD 83).
7.28 City of Long Beach         Date: July 12, 2013.
 Fireworks.
                                Rain date: July 13, 2013.
                                Time: 9 p.m. to 10:00 p.m.
                                Location: Waters off Riverside
                                Blvd, City of Long Beach, NY in
                                approximate position 40[deg]34'38.77''
                                N, 073[deg]39'41.32'' W (NAD 83).
7.30 Mashantucket Pequot        Date: July 13, 2013.
 Fireworks.
                                Rain date: July 14, 2013.
                                Time: 8:30 p.m. to 10:30 p.m.
                                Location: Waters of the Thames
                                River New London, CT in approximate
                                positions Barge 1, 41[deg]21'03.03'' N,
                                072[deg]5'24.5'' W Barge 2,
                                41[deg]20'51.75'' N, 072[deg]5'18.90'' W
                                (NAD 83).
7.31 Shelter Island Fireworks   Date: July 6, 2013.
                                Rain date: July 7, 2013.
                                Time: 8:30 p.m. to 10:00 p.m.
                                Location: Waters of Gardiner
                                Bay, Shelter Island, NY in approximate
                                position 41[deg]04'39.11'' N,
                                072[deg]22'01.07'' W (NAD 83).
7.35 Groton Long Point Yacht    Date: July 20, 2013.
 Club Fireworks.
                                Rain date: July 21, 2013.
                                Time: 9 p.m. to 10:30 p.m.
                                Location: Waters of Long Island
                                Sound, Groton, CT in approximate
                                position 41[deg]18'05'' N,
                                072[deg]02'08'' W (NAD 83).
8.6 Town of Babylon Fireworks   Date: August 24, 2013.
                                Rain date: August 25, 2013.
                                Time: 8:30 p.m. to 10:00 p.m.

                                Location: Waters off of Cedar
                                Beach Town Park, Babylon, NY in
                                approximate position 40[deg]37'53'' N,
                                073[deg]20'12'' W (NAD 83).
9.1 East Hampton Fire           Date: August 31, 2013.
 Department Fireworks.
                                Rain date: September 1, 2013.
                                Time: 8:45 p.m. to 10:00 p.m.
                                Location: Waters off Main Beach,
                                East Hampton, NY in approximate position
                                40[deg]56'40.28'' N, 072[deg]11'21.26''
                                W (NAD 83).
------------------------------------------------------------------------

    Under the provisions of 33 CFR 100.100 & 33 CFR 165.151, The
fireworks displays, and regatta event listed above are established as
safety zones or special local regulation. During these enforcement
periods, persons and vessels are prohibited from entering into,
transiting through, mooring, or anchoring within the safety zones or
special local regulation unless they receive permission from the COTP
or designated representative.
    This notice is issued under authority of 33 CFR 100, 33 CFR 165 and
5 U.S.C. 552(a). In addition to this notice in the Federal Register,
the Coast Guard will provide the maritime community with advance
notification of this enforcement period via the Local Notice to
Mariners or marine information broadcasts. If the COTP determines that
a regulated area need not be enforced for the full duration stated in
this notice, a Broadcast Notice to Mariners may be used to grant
general permission to enter the regulated area.

    Dated: May 24, 2013.
J.M. Vojvodich,
Captain, U.S. Coast Guard, Captain of the Port Sector Long Island
Sound.
[FR Doc. 2013-13667 Filed 6-7-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: April 17, 2008 (Volume 73, Number 75)]
[Rules and Regulations]
[Page 20781-20782]
[DOCID:fr17ap08-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR, Part 71

[Docket No. FAA-2007-29374; Airspace Docket No. 07-ASW-11]

Establishment of Class D Airspace; Sherman, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action will establish Class D airspace at Sherman, Texas.
Establishment of an Air Traffic Control Tower at Sherman/Denison,
Grayson County Airport, has made this action necessary for the safety
and management of Instrument Flight Rules (IFR) aircraft operations at
Sherman/Denison, Grayson County Airport, Sherman, Texas.

DATES: Effective Date: 0901 UTC, June 5, 2008. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR, Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Gary Mallett, Central Service Center,
System Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76193-0530; telephone (817)
222-4949.

SUPPLEMENTARY INFORMATION:

History

    On December 18, 2007, the FAA published in the Federal Register a
notice of proposed rulemaking to establish Class D airspace at Sherman,
TX (72 FR 71607). This action would improve the safety of IFR aircraft
at Sherman/Denison, Grayson County Airport, Sherman, TX. Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal to the FAA. No comments
were received.
    Class D airspace designations are published in paragraph 5000 of
FAA Order 7400.9R signed August 15, 2007, and effective September 15,
2007, which is incorporated by reference in 14 CFR, Part 71.1. The
Class D airspace

designations listed in this document will be published subsequently in
that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR),
part 71, by establishing Class D airspace extending upward from the
surface to and including 3,300 feet Mean Sea Level (MSL) within a 5-
mile radius of Sherman/Denison, Grayson County Airport.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ''significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA authority to issue rules regarding aviation safety is found
in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the agency's authority. This
rulemaking is promulgated under the authority described in Subtitle
VII, Part A, Subpart I, Section 40103. Under that section, the FAA is
charged with prescribing regulations to assign the use of airspace
necessary to ensure the safety of aircraft and the efficient use of
airspace. This regulation is within the scope of that authority as it
establishes controlled airspace at Sherman/Denison, Grayson County
Airport, Sherman, TX.

List of Subjects in 14 CFR, Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR, part 71, as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR, part 71, continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; EO. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR, part 71.1 of the Federal
Aviation Administration Order 7400.9R, Airspace Designations and
Reporting Points, signed August 15, 2007, and effective September 15,
2007, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ASW TX D Sherman, TX [New]

Sherman/Denison, Grayson County Airport, TX
    (Lat. 33[deg]42'51'' N., long. 96[deg]40'25'' W.)
* * * * *
    That airspace extending upward from the surface to and including
3,300 feet MSL within a 5.0-mile radius of Grayson County Airport.
This Class D airspace area is effective during the specific dates
and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Airport/Facility Directory.
* * * * *

    Issued in Fort Worth, Texas, on: April 4, 2008.
Walter Tweedy,
Acting Manager, System Support Group, ATO Central Service Center.
[FR Doc. E8-8055 Filed 4-16-08; 8:45 am]

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