[Federal Register Volume 86, Number 172 (Thursday, September 9, 2021)]
[Notices]
[Pages 50541-50543]
[FR Doc No: 2021-19437]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0951]

Reconsidering Mandatory Opioid Prescriber Education Through a
Risk Evaluation and Mitigation Strategy in an Evolving Opioid Crisis;
Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Reconsidering
Mandatory Opioid Prescriber Education Through a Risk Evaluation and
Mitigation Strategy (REMS) in an Evolving Opioid Crisis.'' Convened by
the Duke-Margolis Center for Health Policy and supported by a
cooperative agreement between FDA and Duke-Margolis, the purpose of the
public workshop is to give stakeholders an opportunity to provide input
on aspects of the current opioid crisis that could be mitigated in a
measurable way by requiring mandatory prescriber education as part of a
REMS. We expect interested stakeholders to include healthcare
providers, healthcare professional associations, pharmacists, pharmacy
benefit managers, public and private insurers, patient organizations,
Federal and State Agencies, providers of continuing education for
healthcare professionals, and the public. A second public workshop is
being planned to solicit input on additional issues associated with a
move to mandatory prescriber education under a REMS, such as
operational and technical issues related to such a system and what
should be included in potential mandatory prescriber education.

DATES: The public workshop will be held on October 13, 2021, from 1
p.m. to 5 p.m. Eastern Time and October 14, 2021, from 1 p.m. to 4:05
p.m. Eastern Time. Submit either electronic or written comments on this
public workshop by December 3, 2021. See the SUPPLEMENTARY INFORMATION
section for registration date and information.

ADDRESSES: Due to the impact of the COVID-19 pandemic, these meetings
will be held virtually to help protect the public and limit the spread
of the virus.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before December 3, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 3, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-N-0951 for ``Reconsidering Mandatory Opioid Prescriber
Education Through a Risk Evaluation and Mitigation Strategy (REMS) in
an Evolving Opioid Crisis.'' Comments filed and received in a timely
manner (see ADDRESSES) will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The

second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Michie Hunt, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6153, Silver Spring, MD 20993, 301-796-
3504<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    As FDA continues to work to address the opioid crisis, we are
reconsidering our current efforts to ensure prescriber education
regarding opioids is being delivered in a way that is as efficient and
effective as possible. As a part of this work, we are revisiting
whether there is a need for a mandatory form of prescriber education
linked to the prescribing of opioids. In 2012, FDA approved the
Extended Release/Long Acting (ER/LA) Risk Evaluation and Mitigation
Strategy (REMS), at the core of which was a requirement that sponsors
of ER/LA opioid analgesics make an education program available for
healthcare providers who prescribe ER/LA opioid analgesics (e.g.,
physicians, nurse practitioners, and physician assistants). The goal of
the ER/LA opioid analgesic REMS was to reduce serious adverse outcomes
resulting from inappropriate prescribing, misuse, and abuse of ER/LA
opioid analgesics while maintaining patient access to pain medications.
The adverse outcomes of concern included addiction, unintentional
overdose, and death.
    While developing the REMS requirements, FDA considered whether the
education should be made mandatory for prescribers but decided against
making mandatory education a REMS requirement at the time. This was due
to concerns about placing an undue burden on the healthcare delivery
system, in part because the implementation of mandatory education
through the REMS might have required a restricted distribution system.
It is possible that given technological advances in the intervening
years, including broader implementation of e-prescribing for controlled
substances, there might be ways to lessen the burden associated with a
restricted distribution system, including potential negative impact on
patients who need opioids for pain management.
    When the REMS was put in place in 2012, instead of mandatory
education, FDA required that ER/LA opioid manufacturers make the
training available to prescribers at no or nominal cost and that the
training be accessible in a variety of different formats. FDA also
recommended that the training be offered for continuing education (CE)
credit. The REMS as implemented requires the training to conform to a
blueprint (available at https://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_analgesic_2018_09_18_FDA_Blueprint.pdf) developed by FDA
that contains a high-level outline of the core educational messages to
be included in the CE programs developed under the REMS. The initial
education program included general and product-specific information
about the ER/LA opioid analgesics; information on proper patient
selection for use of these drugs; guidance for safely initiating
therapy, modifying dosing, and discontinuing use of ER/LA opioid
analgesics; guidance for monitoring patients; and information for
counseling patients and caregivers about the safe use of these drugs.
    After reviewing existing requirements and considering Advisory
Committee recommendations obtained in 2016 about the ER/LA REMS, in
2018 FDA expanded the REMS to include both immediate release (IR)
opioid analgesics and ER/LA opioid analgesics intended for use in an
outpatient setting. The content of the blueprint was redesigned to
contain principles of appropriate pain management, including the use of
alternatives to opioids for the treatment of pain; the basic elements
of addiction medicine; and the neurobiology, identification, and
management of opioid use disorder. The blueprint currently does not
include principles for managing opioid use disorder, including
treatment with buprenorphine. The revised Opioid Analgesic (OA) REMS
also expanded the prescriber audience and requires that the OA
manufacturers make training available to all members of the healthcare
team involved in the management of patients with pain, including nurses
and pharmacists. As with the ER/LA REMS, training under the OA REMS is
voluntary.
    Cumulatively, from February 28, 2013, through May 15, 2021, there
have been 354,949 completers of REMS CE from the ER/LA REMS and the OA
REMS. For context, there were approximately 1 million prescribers of
opioid analgesics in 2019. In addition, although many public and
private entities have independently implemented their own education
programs and other interventions to encourage safe and effective
prescribing practices for opioid analgesics, there is no nationwide
standard. Therefore, these programs likely differ with regard to
content, focus, and duration.
    Following the creation and expansion of the REMS and other efforts,
including the introduction of the Centers for Disease Control and
Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain in
2016,\1\ the estimated number of opioid analgesic prescriptions
dispensed per capita in the United States has been steadily declining
from a peak of 84 prescriptions per 100 residents in 2012 to 67
prescriptions per 100 residents in 2016; and 52 prescriptions per 100
residents in 2018. The rate dropped to 43 prescriptions per 100 U.S.
residents in 2020, reflecting levels not seen since the early 1990s (44
prescriptions per 100 U.S. residents in 1992).\2\ Despite this decrease
in dispensing, multiple studies have reported patients received more
opioid analgesic tablets than needed following surgical procedures.
FDA's systematic review of studies published prior to 2019 showed that
in articles reporting on the prescribing of excess tablets, 25 percent
to 98 percent of the total tablets prescribed were reported to be
excess, with most studies reporting that 50 percent to 70 percent of
tablets went unused.\3\ There are also

concerns about continued opioid analgesic prescribing to vulnerable
populations, such as children and adolescents following common dental
and minor surgical procedures.
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    \1\ Dowell, D., T.M. Haegerich, and R. Chou, ``CDC Guideline for
Prescribing Opioids for Chronic Pain--United States, 2016''. JAMA,
(2016) 315(15):1624-1645.
    \2\ IQVIA Institute, ``National Prescription Audit'' extracted
March 2021, U.S. Census Bureau.
    \3\ Mallama, C.A., C. Greene, A.A. Alexandridis, et al.
``Patient-Reported Opioid Analgesic Use After Discharge From
Surgical Procedures: A Systematic Review.'' (2021) Pain Medicine,
doi: 10.1093/pm/pnab244.
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    Despite this decline in opioid analgesic dispensing, overall
opioid-involved overdose deaths have risen sharply since 2012, with
opioids often seen in combination with other substances such as
cocaine, methamphetamine, and benzodiazepines.4 5 This rise
has been driven primarily by a surge in deaths initially involving
heroin and then illicitly manufactured fentanyl and fentanyl analogues.
Although these overdose deaths largely involve illicit substances, many
users of illicit opioids are initially exposed to opioids through
nonmedical use of prescription opioids.\6\ Moreover, as of 2020,
prescription opioids were involved in more than 16,000 fatal overdoses
per year,\7\ higher than the number seen at the peak of opioid
analgesic dispensing in 2012.\8\
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    \4\ National Institute on Drug Abuse, ``Overdose Death Rates.''
(2021) (Available at: https://www.drugabuse.gov/drug-topics/trends-statistics/overdose-death-rates) (accessed August 20, 2021).
    \5\ Mattson C.L., L.J. Tanz, K. Quinn, et al, ``Trends and
Geographic Patterns in Drug and Synthetic Opioid Overdose Deaths--
United States, 2013-2019.'' Morbidity and Mortality Weekly Report,
(2021) 70(6):202-207.
    \6\ Compton, W.M., C.M. Jones, and G.T. Baldwin, ``Relationship
Between Nonmedical Prescription-Opioid Use and Heroin Use.'' New
England Journal of Medicine, (2016) 374:154-163.
    \7\ Ahmad, F.B., L.M. Rossen, and P. Sutton, ``Provisional Drug
Overdose Death Counts.'' National Center for Health Statistics,
2021. (Available at: https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm) (accessed 8/20/2021).
    \8\ National Institute on Drug Abuse, ``Overdose Death Rates.''
January 29, 2021. (Available at: https://www.drugabuse.gov/drug-topics/trends-statistics/overdose-death-rates).
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    Against this background of a complex and intensifying crisis, FDA
is reconsidering the need for mandatory prescriber training through a
REMS and seeks input from stakeholders about the aspects of the opioid
crisis that mandatory training through such a REMS could potentially
mitigate. In light of the many available education programs and the
lack of a nationwide standard, FDA is exploring the value of a single
source for education on the appropriate use of opioids, on the risks of
opioid abuse and misuse, and on the treatment of opioid use disorder to
address multiple needs and reduce the burden on prescribers.

II. Topics for Discussion at the Public Workshop

    1. How could mandatory prescriber education through a REMS improve
appropriate opioid prescribing, pain management, and the treatment of
opioid use disorder?
    a. Please specifically discuss the value of such a system in light
of existing continuing education requirements, the wide array of
available educational programs (including currently available OA REMS
educational offerings), and other interventions by Federal Agencies,
States, healthcare systems, retail pharmacies, payers, pharmacy benefit
managers, and other public and private organizations. Could mandatory
education under a REMS make prescriber education more consistent,
efficient, and effective?
    b. Please specifically discuss how a mandatory REMS educational
program could address the needs for prescriber education on the
overprescribing of opioids for acute pain.
    c. Please specifically discuss how a mandatory REMS educational
program could address the needs for prescriber education on the
treatment of opioid use disorder.
    2. What are the important core competencies, knowledge gaps,
clinical challenges, or misunderstandings among practitioners that
could be addressed through mandatory education under a REMS to help
improve patient outcomes and mitigate the current crisis?
    a. Please comment specifically on any key knowledge gaps or core
competencies related to screening, diagnosis, or treatment of opioid
use disorder or substance use disorder that should be incorporated into
mandatory education for opioid prescribers.
    3. If FDA were to implement a mandatory prescriber education
program, please discuss what appropriate program goals might be. How
could we measure the impacts of such a program and determine whether it
is meeting its goals?
    4. Regarding the implementation of such a mandatory REMS
educational system:
    a. Please discuss challenges you foresee in the implementation of a
mandatory REMS educational system.
    b. What can we learn about the implementation of prescriber
education from existing educational programs in pain management, in
opioid risk reduction, and in the treatment of opioid use disorder?
    5. What could be unintended consequences of mandatory opioid
prescriber education through a REMS and are there ways to identify and
address them?
    Although not specifically discussed at this Public Workshop, FDA is
interested in obtaining input on additional issues, including:
    a. The continuing education delivery approaches, methods, and
information technology platforms that should be considered to maximize
the acceptability and effectiveness of mandatory prescriber education.
    b. Any technological advances since 2012 that would make the
delivery of mandatory training more efficient and reduce burden on the
healthcare system.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the
following website: http://events.constantcontact.com/register/event?llr=4fyj4myab&oeidk=a07eifbycnsfd5b6b1f. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone.
    Registration is free. Persons interested in attending this public
workshop must register by 4:05 p.m. Eastern Time on October 14, 2021.
Registrants will receive confirmation when they have been accepted.
Registered participants will be sent technical system requirements in
advance of the event. We recommend that you review these technical
system requirements prior to joining the virtual public workshop. The
workshop will be recorded, and the recording will be available after
the workshop at https://healthpolicy.duke.edu/events/fda-public-workshop-opioid-prescriber-education.
    There will be live closed captioning for this event. If you need
other special accommodations due to a disability, please contact Michie
Hunt (see FOR FURTHER INFORMATION CONTACT) no later than October 4,
2021, or the Duke-Margolis Center for Health Policy at
<EMAIL_ADDRESS>    FDA has verified the website addresses in this document, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.

    Dated: September 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19437 Filed 9-8-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 29 (Tuesday, February 12, 2013)]
[Notices]
[Pages 9928-9929]
[FR Doc No: 2013-03198]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0124]

Food and Drug Administration Drug Shortages Task Force and
Strategic Plan; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: To assist the Food and Drug Administration (FDA or Agency) in
drafting a strategic plan on drug shortages as required by the Food and
Drug Administration Safety and Innovation Act, the Agency is seeking
public comment from interested persons on certain questions related to
drug and biological product shortages.

DATES: Submit either electronic or written comments by March 14, 2013.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0124, by any of the following methods:
    Electronic Submissions:
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
    Written Submissions:
    Submit written submissions in the following way:
     Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2013-N-0124. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kalah Auchincloss, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6208; Silver Spring, MD 20993, 301-796-
0659.

SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, the President signed into law the Food and Drug
Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144).
Section 1003 of FDASIA adds section 506D to the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to require the formation of a task force to
develop and implement a strategic plan for enhancing the Agency's
response to preventing and mitigating drug shortages. Section 506D of
the FD&C Act (21 U.S.C. 356D) requires that the drug shortages
strategic plan include the following:
     Plans for enhanced interagency and intra-agency
coordination, communication, and decisionmaking;
     Plans for ensuring that drug shortages are considered when
the

Secretary initiates a regulatory action that could precipitate a drug
shortage or exacerbate an existing drug shortage;
     Plans for effective communication with outside
stakeholders, including who the Secretary should alert about potential
or actual drug shortages, how the communication should occur, and what
types of information should be shared;
     Plans for considering the impact of drug shortages on
research and clinical trials; and
     An examination of whether to establish a ``qualified
manufacturing partner program'' as described in section 506D(a)(1)(C)
of the FD&C Act.

II. Scope of Public Input Requested

    Per the directive in section 506D, FDA has formed an internal Drug
Shortages Task Force (Task Force) to develop and implement the drug
shortages strategic plan. The Task Force is seeking comments from the
public on issues related to the development of this strategic plan.
Importantly, although FDASIA refers only to a drug shortages strategic
plan, we anticipate that the strategic plan will consider prevention
and mitigation of both drug and biological product shortages.
Accordingly, we are interested in receiving comments on these questions
from all parties, including those with an interest in biological
products. The Task Force is specifically interested in seeking public
input on the following questions:
    1. In an effort to address the major underlying causes of drug and
biological product shortages, FDA is seeking new ideas to encourage
high-quality manufacturing and to facilitate expansion of manufacturing
capacity.
    a. To assist in the evaluation of product manufacturing quality,
FDA is exploring the broader use of manufacturing quality metrics. With
that in mind, FDA would like input on the following issues: What
metrics do manufacturers currently use to monitor production quality?
To what extent do purchasers and prescribers use information about
manufacturing quality when deciding how to purchase or utilize
products? What kinds of manufacturing quality metrics might be valuable
for purchasers and prescribers when determining which manufacturers to
purchase from or which manufacturers' products to prescribe? What kinds
of manufacturing quality metrics might be valuable for manufacturers
when choosing a contract manufacturer? How frequently would such
metrics need to be updated to be meaningful?
    b. The use of a qualified manufacturing partner program similar to
one used under the Biomedical Advanced Research and Development
Authority (BARDA) has been suggested as a potentially useful approach
to expanding manufacturing capacity and preventing shortages. FDA
recognizes that there are important potential differences between the
BARDA program and the use of a parallel program to address shortages.
For example, the BARDA program covers a relatively stable and limited
number of products, but drugs at risk of shortage are many, may change
rapidly over time, and are difficult to predict in advance. In
addition, FDA does not have funding to pay manufacturers to participate
in a drug shortages qualified manufacturing partner program or to
guarantee purchase of the end product. With these differences in mind,
is it possible to design a qualified manufacturing partner program that
would have a positive impact on shortages?
    c. Are there incentives that FDA can provide to encourage
manufacturers to establish and maintain high-quality manufacturing
practices, to develop redundancy in manufacturing operations, to expand
capacity, and/or to create other conditions to prevent or mitigate
shortages?
    2. In our work to prevent shortages of drugs and biological
products, FDA regularly engages with other U.S. Government Agencies.
Are there incentives these Agencies can provide, separately or in
partnership with FDA, to prevent shortages?
    3. When notified of a potential or actual drug or biological
product shortage, FDA may take certain actions to mitigate the impact
of the shortage, including expediting review of regulatory submissions,
expediting inspections, exercising enforcement discretion, identifying
alternative manufacturing sources, extending expiration dates based on
stability data, and working with the manufacturer to resolve the
underlying cause of the shortage. Are there changes to these existing
tools that FDA can make to improve their utility in managing shortages?
Are there other actions that FDA can take under its existing authority
to address impending shortages?
    4. To manage communications to help alleviate potential or actual
shortages, FDA uses a variety of tools, including posting information
on our public shortages Web sites and sending targeted notifications to
specialty groups. Are there other communication tools that FDA should
use or additional information the Agency should share to help health
care professionals, manufacturers, distributors, patients, and others
manage shortages more effectively? Are there changes to our public
shortage Web sites that would help enhance their utility for patients,
prescribers, and others in managing shortages?
    5. What impact do drug and biological product shortages have on
research and clinical trials? What actions can FDA take to mitigate any
negative impact of shortages on research and clinical trials?
    6. What other actions or activities should FDA consider including
in the strategic plan to help prevent or mitigate shortages?

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: February 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03198 Filed 2-11-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 28 (Monday, February 11, 2019)]
[Notices]
[Pages 3157-3158]
[FR Doc No: 2019-01904]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9989-19-Region 1]

Proposed CERCLA Administrative Cost Recovery Settlement:
Fletchers Paint Works Site, Milford, New Hampshire

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed settlement; request for public comments.

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SUMMARY: Notice is hereby given of a proposed administrative cost
settlement for recovery of response costs concerning the Fletchers
Paint Works Site, located in Milford, New Hampshire, with the Settling
Party, the General Electric Company. The proposed settlement requires
the

Settling Party pay the Environmental Protection Agency (EPA) $3,214,000
to settle EPA's past response costs, which amount to approximately
$4,047,398. In exchange, EPA will provide the Settling Party with a
covenant not to sue for past costs. The settlement has been approved by
the Environmental and Natural Resources Division of the United States
Department of Justice. For 30 days following the date of publication of
this notice, the Agency will receive written comments relating to the
settlement for recovery of response costs. The Agency will consider all
comments received and may modify or withdraw its consent to this cost
recovery settlement if comments received disclose facts or
considerations which indicate that the settlement is inappropriate,
improper, or inadequate. The Agency's response to any comments received
will be available for public inspection at the Environmental Protection
Agency--Region I, 5 Post Office Square, Suite 100, Boston, MA 02109-
3912.

DATES: Comments must be submitted by March 13, 2019.

ADDRESSES: Comments should be addressed to RuthAnn Sherman, Senior
Enforcement Counsel, U.S. Environmental Protection Agency, 5 Post
Office Square, Suite 100 (OES04-2), Boston, MA 02109-3912 (Telephone
No.<PHONE_NUMBER>) and should reference the Fletchers Paint Works Site,
U.S. EPA Docket No: CERCLA 01-2019-0003.

FOR FURTHER INFORMATION CONTACT: A copy of the proposed settlement may
be obtained from RuthAnn Sherman, U.S. Environmental Protection Agency,
Region I, 5 Post Office Square, Suite 100 (OES04-2), Boston, MA 02109-
3912,<PHONE_NUMBER><EMAIL_ADDRESS>Technical questions can
also be directed to Jim Brown, U.S. Environmental Protection Agency,
Region I, 5 Post Office Square, Suite 100 (OSRR07-1), Boston, MA 02109-
3912,<PHONE_NUMBER><EMAIL_ADDRESS>For legal questions, RuthAnn
Sherman, Office of Environmental Stewardship, U.S. Environmental
Protection Agency, Region I, 5 Post Office Square, Suite 100 (OES04-2),
Boston, MA 02109-3912,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This proposed administrative settlement for
recovery of past response costs concerning the Fletchers Paint Works
Site, located in Milford, New Hampshire, is made in accordance with
Section 122(h)(l) of the Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA). EPA covenants not to sue or
take administrative action against the Settling Party, the General
Electric Company, pursuant to Section 107(a) of CERCLA, 42 U.S.C.
9607(a), for Past Response Costs. In exchange, the Settling Party
agrees to pay EPA $3,214,000. Payment of such amount shall be due
within 30 days after the Effective Date. If payment is not paid as
stipulated, interest shall accrue and continue to accrue on any unpaid
amount until the total amount due has been received. For 30 days
following the date of publication of this notice, the Agency will
receive written comments relating to the settlement for recovery of
response costs. The Effective Date of the Agreement is the date upon
which EPA notifies the General Electric Company that the public comment
period has closed and that such comments, if any, do not require that
EPA modify or withdraw from the Agreement.

    Dated: December 12, 2018.
Bryan Olson,
Director, Office of Site Remediation and Restoration.
[FR Doc. 2019-01904 Filed 2-8-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 8 (Wednesday, January 12, 2011)]
[Notices]
[Pages 2127-2128]
[FR Doc No: 2011-459]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0468]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Patent Term
Restoration, Due Diligence Petitions, Filing, Format, and Content of
Petitions

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
February 11, 2011.

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 e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0233.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, 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. Patent Term Restoration, Due Diligence Petitions,
Filing, Format, and Content of Petitions--(OMB Control Number 0910-
0233)--Extension
    FDA's patent extension activities are conducted under the authority
of the Drug Price Competition and Patent Term Restoration Act of 1984
(21 U.S.C. 355(j)) and the Animal Drug and Patent Term Restoration Act
of 1988 (35 U.S.C. 156). New human drug, animal drug, human biological,
medical device, food additive, or color additive products regulated by
the FDA must undergo FDA safety, or safety and effectiveness, review
before marketing is permitted. Where the product is covered by a
patent, part of the patent's term may be consumed during this review,
which diminishes the value of the patent. In enacting the Drug Price
Competition and Patent Term Restoration Act of 1984 and the Animal Drug
and Patent Term Restoration Act of 1988, Congress sought to encourage
development of new, safer, and more effective medical and food additive
products. It did so by authorizing the U.S. Patent and Trademark Office
(PTO) to extend the patent term by a portion of the time during which
FDA's safety and effectiveness review prevented marketing of the
product. The length of the patent term extension is generally limited
to a maximum of 5 years, and is calculated by PTO based on a statutory
formula. When a patent holder submits an application for patent term
extension to PTO, PTO requests information from FDA, including the
length of the regulatory review period for the patented product. If PTO
concludes that the product is eligible for patent term extension, FDA
publishes a notice that describes the length of the regulatory review
period and the dates used to calculate that period. Interested parties
may request, under Sec.  60.24 (21 CFR 60.24), revision of the length
of the regulatory review period, or may petition under Sec.  60.30 (21
CFR 60.30) to reduce the regulatory review period by any time where
marketing approval was not pursued with ``due diligence.''
    The statute defines due diligence as ``that degree of attention,
continuous directed effort, and timeliness as may reasonably be
expected from, and are ordinarily exercised by, a person during a
regulatory review period.'' As provided in Sec.  60.30(c), a due
diligence petition ``shall set forth sufficient facts, including dates
if possible, to merit an investigation by FDA of whether the applicant
acted with due diligence.'' Upon receipt of a due diligence petition,
FDA reviews the petition and evaluates whether any change in the
regulatory review period is necessary. If so, the corrected regulatory
review period is published in the Federal Register. A due diligence
petitioner not satisfied with FDA's decision regarding the petition
may, under Sec.  60.40 (21 CFR 60.40), request an informal hearing for
reconsideration of the due diligence determination. Petitioners are
likely to include persons or organizations having knowledge that FDA's
marketing permission for that product was not actively pursued
throughout the regulatory review period. The information collection for
which an extension of approval is being sought is the use of the
statutorily created due diligence petition.
    Since 1992, 12 requests for revision of the regulatory review
period have been submitted under Sec.  60.24. For 2007, 2008, and 2009,
a total of three, or one per year, have been submitted under Sec.
60.24. Two regulatory review periods have been altered. During that
same time period, two due diligence petitions were submitted to FDA
under Sec.  60.30, for an average of fewer than one per year. There
have been no requests for hearings under Sec.  60.40 regarding the
decisions on such petitions; however, for purposes of this information
collection approval, we are estimating that we may receive one
submission annually.
    In the Federal Register of October 5, 2010 (75 FR 61493), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received on the information
collection.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
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                                                      Annual
         21 CFR section              Number of    frequency  per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
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60.24(a)........................               1               1               1             100             100
60.30...........................               1               1               1              50              50
60.40...........................               1               1               1              10              10
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             160
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: January 5, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-459 Filed 1-11-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 66 (Tuesday, April 7, 2015)]
[Rules and Regulations]
[Pages 18526-18528]
[FR Doc No: 2015-07821]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2014-0477; FRL-9925-77-Region 10]

Approval and Promulgation of Implementation Plans; Idaho

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to partially approve the May 22, 2014, State Implementation Plan
(SIP) submittal from Idaho to revise the SIP to update the
incorporation by reference of Federal air quality regulations into the
SIP. The EPA is also taking final action to partially disapprove
Idaho's incorporation by reference of certain provisions of the Federal
prevention of significant deterioration (PSD) permitting rules that
have been vacated by a Federal Court. As a result of this action, the
Idaho SIP is updated to incorporate by reference certain Federal
regulations as of July 1, 2013.

DATES: This final rule is effective on May 7, 2015.

ADDRESSES: The EPA has established a docket for this action under
Docket Identification No. EPA-R10-OAR-2014-0477. All documents in the
docket are listed on the http://www.regulations.gov Web site. Although
listed in the index, some information may not be publicly available,
i.e., Confidential Business Information or other information the
disclosure of which is restricted by statute. Certain other material,
such as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically through http://www.regulations.gov or in hard copy at EPA Region 10, Office of Air,
Waste, and Toxics, AWT-150, 1200 Sixth Avenue, Seattle, Washington
98101. The EPA requests that you contact the person listed in the FOR
FURTHER INFORMATION CONTACT section to schedule your inspection. The
Regional Office's official hours of business are Monday through Friday,
8:30 a.m. to 4:30 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Donna Deneen at<PHONE_NUMBER>,
<EMAIL_ADDRESS>or by using the above EPA, Region 10 address.

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we,''
``us'' or ``our'' is used, it is intended to refer to the EPA.

Table of Contents

I. Background
II. Final Action
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. Background

    In a notice of proposed rulemaking published on January 7, 2015 (80
FR 834), the EPA proposed action on revisions to the Idaho SIP to
account for regulatory updates adopted by the Idaho Board of
Environmental Quality on October 17, 2013 and submitted to the EPA on
May 22, 2014. Please see our January 7, 2015, proposed rulemaking for
further explanation of the revisions and the basis for our proposal to
partially approve and partially disapprove the May 22, 2014, SIP
submittal from Idaho. The public

comment period for the proposed rule ended on February 6, 2015. No
comments were received on the proposal.

II. Final Action

Provisions the EPA is Approving and Incorporating by Reference

    Consistent with the discussion and analysis in the proposed
rulemaking published on January 7, 2015, the EPA is partially approving
and incorporating by reference the May 22, 2014, submittal from Idaho.
Specifically, we are approving and incorporating by reference the
revisions to IDAPA <IP_ADDRESS>.02 ``Availability of Reference
Materials'' and IDAPA <IP_ADDRESS>.03 ``Incorporations by Reference,''
except that we are partially disapproving the revision to IDAPA
<IP_ADDRESS>.03(c) as it relates to the incorporation by reference of
specific vacated provisions at 40 CFR 52.21 (namely, 40 CFR
52.21(i)(5)(i)(c) and 40 CFR 52.21(k)(2)) for the reasons discussed in
the proposal. This action updates the Idaho SIP to incorporate by
reference certain Federal regulations as of July 1, 2013.

III. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the Idaho
Department of Environmental Quality regulations described in the
amendments to 40 CFR part 52 set forth below. The EPA has made, and
will continue to make, these documents generally available
electronically through www.regulations.gov and/or in hard copy at the
appropriate EPA office (see the ADDRESSES section of this preamble for
more information).

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve State choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves State law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by State
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because this action does not involve technical standards; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation
land or in any other area where the EPA or an Indian Tribe has
demonstrated that a Tribe has jurisdiction. In those areas of Indian
country, the rule does not have Tribal implications as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000).

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by June 8, 2015. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2)).

List of Subjects in 40 CFR Part 52

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

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

    Dated: March 9, 2015.
Dennis J. McLerran,
Regional Administrator, Region 10.
    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart N--Idaho

0
2. In Sec.  52.670, the table in paragraph (c) is amended by revising
entry 107 to read as follows:

Sec.  52.670  Identification of plan.

* * * * *
    (c) * * *

                                   EPA-Approved Idaho Regulations and Statutes
----------------------------------------------------------------------------------------------------------------
                                                     State effective
         State citation            Title/subject           date        EPA Approval date       Explanations
----------------------------------------------------------------------------------------------------------------
      Idaho Administrative Procedures Act (IDAPA) 58.01.01--Rules for the Control of Air Pollution in Idaho
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
107............................  Incorporations by  3/20/2014, 3/30/   4/7/2015 [Insert   Except Section
                                  Reference.         2007,.             Federal Register   107.03(f) through
                                                    7/1/1997,........   citation].         (p), and with respect
                                                    5/1/1994.........                      to 107.03(c), its
                                                                                incorporation by
                                                                                reference of 40 CFR
                                                                                52.21(i)(5)(i)(c) and
                                                                                (k)(2).

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

* * * * *
0
3. Section 52.683 is amended by revising paragraph (a) to read as
follows:

Sec.  52.683  Significant deterioration of air quality.

    (a) The State of Idaho Rules for Control of Air Pollution in Idaho,
specifically, IDAPA <IP_ADDRESS> through 007 (definitions), IDAPA
<IP_ADDRESS>.03(a), (b), (c) (incorporations by reference)(except, with
respect to Section 107.03(c), its incorporation by reference of 40 CFR
52.21(i)(5)(i)(c) and (k)(2)), IDAPA <IP_ADDRESS> through 222 (permit
to construct rules); IDAPA <IP_ADDRESS>0 through 516 (stack height
rules); and IDAPA <IP_ADDRESS>5 through 581 (standards, increments and
area designations) (except Section 577), are approved as meeting the
requirements of title I, part C, subpart 1 of the Clean Air Act for
preventing significant deterioration of air quality.
* * * * *
[FR Doc. 2015-07821 Filed 4-6-15; 8:45 am]
BILLING CODE CODE 6560-50-P


[Federal Register: January 16, 2007 (Volume 72, Number 9)]
[
Notices]
[Page 1793-1794]
[DOCID:fr16ja07-94]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55058; File No. SR-DTC-2006-17]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Adding the Security Holder Report Service to the Security Position
Report Service

January 8, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on November 17, 2006, The
Depository Trust Company (``DTC'') filed with the Securities and
Exchange Commission (``Commission'') and on January 5, 2007, amended
the proposed rule change described in Items I, II, and III below, which
items have been prepared primarily by DTC. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested parties.
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    \1\ 15 U.S.C. 78s(b)(1).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The purpose of the proposed rule change is to add a new service,
the Security Holder Report (``SHR'') service, to DTC's Security
Position Report (``SPR'') service.

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

    In its filing with the Commission, DTC 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. DTC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.\2\
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    \2\ The Commission has modified the text of the summaries
prepared by DTC.
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(A) Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    SPRs are reports prepared by DTC that show for each issuer whose
securities are eligible for DTC's book entry services the identity of
each DTC participant having that issuer's securities credited to its
participant account and the quantity of that issuer's securities that
the DTC participant has credited to its participant account as of a
selected date. Most securities are registered with the issuer's
transfer agent in the name of DTC's nominee, Cede & Co. Issuers rely on
DTC to provide them with SPR information. DTC also provides SPR
information to trustees and authorized third party agents. These
entities typically need SPR information provided by DTC in order to
properly conduct proxy, record date, and voting rights related
functions.
    Some authorized users of the SPR service also perform regulatory
reporting functions for which they require the participants' identities
but do not need the corresponding quantity of securities credited to
each participant. Currently, such users are required to order from DTC
an SPR, which costs $120 per CUSIP. In order to mitigate user expenses,
DTC is proposing to offer the SHR service as part of its SPR service.
The SHR will allow authorized users to obtain reports with only
participant identity. SHRs will result in lower production costs to DTC
and in greater protection of participant information and will allow a
lower fee to be charged than that for standard SPRs. The SHR fees are:
    (i) $55.00 per CUSIP for the first 500 CUSIPS and
    (ii) $6.00 per CUSIP for requests of 501 or more CUSIPS.
    The proposed rule change is consistent with the requirements of
Section 17A of the Act \3\ and the rules and regulations thereunder
applicable to DTC because it will foster cooperation and coordination
with persons engaged in the clearance and settlement of securities
transactions and, in general, protects investors and the public
interest.
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    \3\ 15 U.S.C. 78q-1.
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(B) Self-Regulatory Organization's Statement on Burden on Competition

    DTC does not believe that the proposed rule change will have any
impact on or impose any burden on competition.

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

    No written comments relating to the proposed rule change have been
solicited or received. DTC will notify the Commission of any written
comments received by DTC.

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

    The foregoing rule change has become effective upon filing pursuant
to Section 19(b)(3)(A)(iii) of the Act \4\ and Rule 19b-4(f)(4) \5\
thereunder because the proposed rule change effects a change in an
existing service of DTC that (i) does not adversely affect the
safeguarding of securities or funds in the custody or control of DTC or
for which it is responsible and (ii) does not significantly affect the
respective rights or obligations of DTC or persons using the service.
At any time within sixty days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.\6\
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    \4\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \5\ 17 CFR 240.19b-4(f)(4).
    \6\ For purposes of calculating the 60-day period within which
the Commission may summarily abrogate the proposed rule change under
Section 19(b)(3)(C) of the Act, the Commission considers the period
to commence on January 5, 2007, the date on which the last amendment
to the proposed rule change was filed with the Commission. 15 U.S.C.
78s(b)(3)(C).
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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 e-mail to<EMAIL_ADDRESS>Please include

File

Number SR-DTC-2006-17 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-DTC-2006-17. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549. Copies of such filing also will be available
for inspection and copying at the principal office of DTC and on DTC's
Web site at https://login.dtcc.com/dtcorg/. All comments received will

be posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-DTC-2006-17 and should be submitted on
or before February 6, 2007.
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    \7\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\7\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-389 Filed 1-12-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 202 (Thursday, October 18, 2018)] [Notices] [Pages 52827-52828] [FR Doc No: 2018-22715]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER19-89-000]

North Rosamond Solar, LLC; Supplemental Notice That Initial

Market-Based Rate Filing Includes Request for Blanket Section 204

Authorization

    This is a supplemental notice in the above-referenced proceeding of

North Rosamond Solar, LLC's application for market-based rate

authority, with an accompanying rate tariff, noting that such

application includes a request for blanket authorization, under 18 CFR

part 34, of future issuances of securities and assumptions of

liability.

    Any person desiring to intervene or to protest should file with the

Federal Energy Regulatory Commission, 888 First Street NE, Washington,

DC 20426, in accordance with Rules 211 and 214 of the Commission's

Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone

filing a motion to intervene or protest must serve a copy of that

document on the Applicant.

    Notice is hereby given that the deadline for filing protests with

regard to the applicant's request for blanket authorization, under 18

CFR part 34, of

future issuances of securities and assumptions of liability, is

November 1, 2018.

    The Commission encourages electronic submission of protests and

interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet

access who will eFile a document and/or be listed as a contact for an

intervenor must create and validate an eRegistration account using the

eRegistration link. Select the eFiling link to log on and submit the

intervention or protests.

    Persons unable to file electronically should submit an original and

5 copies of the intervention or protest to the Federal Energy

Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in

the Commission's eLibrary system by clicking on the appropriate link in

the above list. They are also available for electronic review in the

Commission's Public Reference Room in Washington, DC. There is an

eSubscription link on the website that enables subscribers to receive

email notification when a document is added to a subscribed docket(s).

For assistance with any FERC Online service, please email

[email protected] or call<PHONE_NUMBER> (toll free). For TTY,

call<PHONE_NUMBER>.

    Dated: October 12, 2018.

Nathaniel J. Davis, Sr.,

Deputy Secretary.

[FR Doc. 2018-22715 Filed 10-17-18; 8:45 am]

 BILLING CODE 6717-01-P


[Federal Register: July 14, 2010 (Volume 75, Number 134)]
[Notices]
[Page 40815]
[DOCID:fr14jy10-53]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL08-47-006]

PJM Interconnection, L.L.C.; Notice of Filing

July 7, 2010.
    Take notice that on July 1, 2010, PJM Interconnection, L.L.C. (PJM)
filed revised sheets to Schedule 1 of the Amended and Restated
Operating Agreement of PJM Interconnection, L.L.C. (Operating
Agreement) and the parallel provisions of Attachment K--Appendix of the
PJM Open Access Transmission Tariff, and also revisions to Schedule 2
of PJM's Operating Agreement, pursuant to the Federal Energy Regulatory
Commission's February 19, 2009 Initial Order on Market Power Mitigation
Provisions and Establishing Procedures, PJM Interconnection, L.L.C.,
126 FERC ] 61,145 (2009) (February 19th Order), May 28, 2009 Order On
Clarification, PJM Interconnection, L.L.C., 127 FERC ] 61,188 (2009)
(May 28th Order), and March 23, 2010 Order on Compliance Filing, PJM
Interconnection, L.L.C., 130 FERC ] 61,230 (2010) (March 30th Order).
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on July 22, 2010

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-17103 Filed 7-13-10; 8:45 am]
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[Federal Register Volume 84, Number 113 (Wednesday, June 12, 2019)]
[Notices]
[Page 27323]
[FR Doc No: 2019-12398]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL19-79-000]

LSP Transmission Holdings II, LLC, Cardinal Point Electric, LLC,
LS Power Midcontinent, LLC v. Midcontinent Independent System Operator,
Inc.; Notice of Complaint

    Take notice that on June 5, 2019, pursuant to sections 206, 306 and
309 of the Federal Power Act 16 U.S.C. 824e, 825e and 825h and Rule 206
of the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.206, LSP Transmission Holdings II,
LLC, Cardinal Point Electric, LLC and LS Power Midcontinent, LLC
(collectively, LS Power or Complainants) filed a formal complaint
against Midcontinent Independent System Operator, Inc. (MISO or
Respondent) requesting that the Commission direct MISO to make
modifications to its transmission planning process, all as more fully
explained in the complaint.
    LS Power certifies that copies of the Complaint were served on the
contacts for MISO as listed on the Commission's list of Corporate
Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondents'
answers and all interventions, or protests must be filed on or before
the comment date. The Respondents' answers, motions to intervene, and
protests must be served on the Complainant.
    The Commission encourages electronic submissions of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
eLibrary link and is available for review in the Commission's Public
Reference Room in Washington, DC. There is an eSubscription link on the
website that enables subscribers to receive email notification when a
document is added to a subscribed docket(s). For assistance with any
FERC Online service, please email<EMAIL_ADDRESS>or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on June 25, 2019.

    Dated: June 6, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-12398 Filed 6-11-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: September 28, 2007 (Volume 72, Number 188)]
[Proposed Rules]
[Page 55118-55120]
[DOCID:fr28se07-34]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-29333; Directorate Identifier 2007-NM-141-AD]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 737-600, -700, -700C, -
800, and -900 Series Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Boeing Model 737-600, -700, -700C, -800, and -900 series
airplanes. This proposed AD would require various repetitive
inspections to detect cracks along the chemically milled steps of the
fuselage skin or missing or loose fasteners in the area of the
preventative modification or repairs, replacement of the time-limited
repair with the permanent repair if applicable, and applicable
corrective actions if necessary, which would end certain repetitive
inspections. This proposed AD results from a fatigue test that revealed
numerous cracks in the upper skin panel at the chemically milled step
above the lap joint. We are proposing this AD to detect and correct
such fatigue-related cracks, which could result in the crack tips
continuing to turn and grow to the point where the skin bay flaps open,
causing decompression of the airplane.

DATES: We must receive comments on this proposed AD by November 13,
2007.

ADDRESSES: Use one of the following addresses to submit comments on
this proposed AD.
     DOT Docket Web site: Go to http://dms.dot.gov and follow

the instructions for sending your comments electronically.
     Governmentwide rulemaking Web site: Go to http://www.regulations.gov
 and follow the instructions for sending your

comments electronically.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Fax:<PHONE_NUMBER>.
     Hand Delivery: Room W12-140 on the ground floor of the
West Building, 1200 New Jersey Avenue, SE., Washington, DC, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    Contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle,
Washington 98124-2207, for the service information identified in this
proposed AD.

FOR FURTHER INFORMATION CONTACT: Wayne Lockett, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6447; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to submit any relevant written data, views, or
arguments regarding this proposed AD. Send your comments to an address
listed in the ADDRESSES section. Include the docket number ``FAA-2007-
29333; Directorate Identifier 2007-NM-141-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of the proposed AD. We will
consider all comments received by the closing date and may amend the
proposed AD in light of those comments.
    We will post all comments we receive, without change, to http://dms.dot.gov
, including any personal information you provide. We will

also post a report summarizing each substantive verbal contact with FAA
personnel concerning this proposed AD. Using the search function of
that Web site, anyone can find and read the comments in any of our
dockets, including the name of the individual who sent the comment (or
signed the comment on behalf of an association, business, labor union,
etc.). You may review DOT's complete Privacy Act Statement in the
Federal Register published on April 11, 2000 (65 FR 19477-78), or you
may visit http://dms.dot.gov.

Examining the Docket

    You may examine the AD docket on the Internet at http://dms.dot.gov
, or in

person at the Docket Operations office between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The Docket Operations
office (telephone<PHONE_NUMBER>) is located on the ground level of the
West Building at the DOT street address stated in the ADDRESSES
section. Comments will be available in the AD docket shortly after the
Docket Management System receives them.

Discussion

    We have received a report that, during a fatigue test of the
fuselage of a Boeing Model 737-800 series airplane, numerous cracks
were found in the upper skin panel at the chemically milled step above
the lap joint at stringers 4 and 10 on both the left and right sides of
the airplane. The cracks were caused by fatigue stresses generated by
secondary bending in the lap splice. Such fatigue-related cracks, if
not detected and corrected in a timely manner, could result in the
crack tips continuing to turn and grow to the point where the skin bay
flaps open, causing decompression of the airplane.

Relevant Service Information

    We have reviewed Boeing Special Attention Service Bulletin 737-53-
1232, dated April 2, 2007. The service information describes the
following actions:

               Inspections and Replacement, as Applicable
------------------------------------------------------------------------
                               The service bulletin describes procedures
   For airplanes on which--                   for doing--
------------------------------------------------------------------------
The preventative modification  An external eddy current inspection to
 specified in the service       detect cracks of the chemically milled
 bulletin has not been          steps at the upper skin panels and
 installed.                     repetitive external detailed inspections
                                to detect cracks of the skin.
The preventative modification  Repetitive external detailed inspections
 specified in the service       and repetitive external high frequency
 bulletin has been installed.   eddy current (HFEC) inspections to
                                detect cracks or loose or missing
                                fasteners in the area of the
                                preventative modification.
The permanent repair           Repetitive external low frequency eddy
 specified in the service       current (LFEC) inspections to detect
 bulletin has been installed.   cracks in the skin.
                               Repetitive external LFEC inspections to
                                detect cracks of the doubler.
                               Repetitive external detailed inspections
                                to detect cracks or loose or missing
                                fasteners of the permanent repair.
                               Repetitive internal medium frequency eddy
                                current inspections to detect cracks of
                                the skin if doing ``Skin Inspection
                                Option 2'' specified in Table 2 of the
                                service bulletin
The time-limited repair        Repetitive internal and external detailed
 specified in the service       inspections to detect cracks or loose or
 bulletin has been installed.   missing fasteners of the repaired area
                                and replacement of the time-limited
                                repair with the permanent repair.
------------------------------------------------------------------------

    The service information also describes procedures for doing
applicable corrective actions. The corrective actions include
contacting Boeing for certain conditions, replacing any loose or
missing fastener with a new fastener, and installing a permanent
repair, time-limited repair, and preventative modification. For
airplanes on which the preventative modification has not been
installed, accomplishing the preventative modification, time-limited
repair, or permanent repair ends the repetitive external detailed
inspections only.
    The service information also specifies the following compliance
times:
     For the initial inspections and replacement: Compliance
times ranging between 1,500 flight cycles and 56,000 total flight
cycles, depending on the airplane configuration and the inspection
method.
     For the applicable corrective actions: A compliance time
of before further flight.
     For repetitive inspections: Repeat intervals ranging
between 1,100 and 8,000 flight cycles, depending on the airplane
configuration.
    Accomplishing the actions specified in the service information is
intended to adequately address the unsafe condition.

FAA's Determination and Requirements of the Proposed AD

    We have evaluated all pertinent information and identified an
unsafe condition that is likely to exist or develop on other airplanes
of this same type design. For this reason, we are proposing this AD,
which would require accomplishing the actions specified in the service
information described previously, except as discussed under
``Difference Between the Proposed AD and Service Information.''

Difference Between the Proposed AD and Service Information

    The service information specifies to contact the manufacturer for
instructions on how to repair certain conditions, but this proposed AD
would require repairing those conditions in one of the following ways:
     Using a method that we approve; or
     Using data that meet the certification basis of the
airplane, and that have been approved by an Authorized Representative
for the Boeing Commercial Airplanes Delegation Option Authorization
Organization whom we have authorized to make those findings.

Costs of Compliance

    There are about 871 airplanes of the affected design in the
worldwide fleet. This proposed AD would affect about 378 airplanes of
U.S. registry. The proposed inspections would take between 11 and 25
work hours per airplane depending on the airplane configuration, at an
average labor rate of $80 per work hour. Based on these figures, the
estimated cost of the proposed AD for U.S. operators is between
$332,640 and $756,000, or between $880 and $2,000 per airplane, per
inspection cycle.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have 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.
    For the reasons discussed above, I certify that the proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket. See the
ADDRESSES section for a location to examine the regulatory evaluation.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The Federal Aviation Administration (FAA) amends Sec.  39.13 by
adding the following new airworthiness directive (AD):

Boeing: Docket No. FAA-2007-29333; Directorate Identifier 2007-NM-
141-AD.

Comments Due Date

    (a) The FAA must receive comments on this AD action by November
13, 2007.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Boeing Model 737-600, -700, -700C, -800,
and -900 series airplanes, certificated in any category; as
identified in Boeing Special Attention Service Bulletin 737-53-1232,
dated April 2, 2007.

Unsafe Condition

    (d) This AD results from a fatigue test that revealed numerous
cracks in the upper skin panel at the chemically milled step above
the lap joint. We are issuing this AD to detect and correct such
fatigue-related cracks, which could result in the crack tips
continuing to turn and grow to the point where the skin bay flaps
open, causing decompression of the airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Service Bulletin

    (f) The term ``service bulletin,'' as used in this AD, means
Boeing Special Attention Service Bulletin 737-53-1232, dated April
2, 2007.

Inspections and Replacement, as Applicable

    (g) At the applicable compliance times listed in Tables 1, 2,
and 3 of paragraph 1.E., ``Compliance,'' of the service bulletin, or
within the time specified in paragraph (g)(1) or (g)(2) of this AD,
as applicable, whichever occurs later, and thereafter at the
applicable repeat intervals listed in Tables 1, 2, and 3: Do the
applicable inspections and replacement by accomplishing all the
actions specified in the Accomplishment Instructions of the service
bulletin.
    (1) For airplanes specified in Tables 1 and 2 of paragraph 1.E.,
``Compliance,'' of the service bulletin: Do the applicable initial
inspection required by paragraph (g) of this AD within 36 months
after the effective date of this AD.
    (2) For airplanes specified in Table 3 of paragraph 1.E.,
``Compliance,'' of the service bulletin: Do the applicable initial
inspection and replacement required by paragraph (g) of this AD
within 24 months after the effective date of this AD.

Corrective Actions

    (h) If any crack or loose or missing fastener is found during
any applicable inspection required by paragraph (g) of this AD,
before further flight, do the applicable corrective action in
accordance with the service bulletin; except, where the service
bulletin specifies to contact Boeing for appropriate action, before
further flight, repair the crack using a method approved in
accordance with the procedures specified in paragraph (j) of this
AD.

Terminating Action for Certain Repetitive Inspections

    (i) For airplanes on which the preventative modification
specified in the service bulletin has not been installed:
Accomplishing the preventative modification, time-limited repair, or
permanent repair in accordance with the service bulletin ends the
applicable repetitive external detailed inspections required by
paragraph (g) of this AD.

Alternative Methods of Compliance (AMOCs)

    (j)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested in
accordance with the procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD, if it is approved by an
Authorized Representative for the Boeing Commercial Airplanes
Delegation Option Authorization Organization who has been authorized
by the Manager, Seattle ACO, to make those findings. For a repair
method to be approved, the repair must meet the certification basis
of the airplane, and the approval must specifically refer to this
AD.

    Issued in Renton, Washington, on September 21, 2007.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E7-19205 Filed 9-27-07; 8:45 am]

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