[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30928-30929]
[FR Doc No: 2021-12204]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER21-2076-000]

Bulb US, 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
Bulb US 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 June 24, 2021.
    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 may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: June 4, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-12204 Filed 6-9-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 63 (Tuesday, April 4, 2017)]
[Notices]
[Pages 16389-16390]
[FR Doc No: 2017-06614]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR17-9-000]

Whiting Oil and Gas Corporation; Notice of Request for Temporary
Waiver

    Take notice that on March 14, 2017, Whiting Oil and Gas Corporation
(Whiting or Requestor) filed a request for temporary waiver of the
Interstate Commerce Act (ICA), section 6 and section 20, and FERC oil
pipeline tariff and reporting requirements thereunder at 18 CFR parts
341 and 357, with respect to Whiting's Redtail crude petroleum
gathering system in Weld County, Colorado, as more fully explained in
the request.
    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. 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 Requestor.
    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 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible online 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: 5:00 p.m. Eastern time on April 14, 2017.

    Dated: March 29, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-06614 Filed 4-3-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 189 (Monday, September 30, 2019)]
[Notices]
[Pages 51558-51560]
[FR Doc No: 2019-21112]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OA-2019-0370; FRL-9047-2]

Proposed Information Collection Request; Comment Request; Final
Rule at 40 CFR Part 8: Environmental Impact Assessment of
Nongovernmental Activities in Antarctica (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), ``Final Rule at 40 CFR part 8:
Environmental Impact Assessment of Nongovernmental Activities in
Antarctica'' (EPA ICR No. 1808.09, OMB Control No. 2020-0007) to the
Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. Before doing so, the EPA
is soliciting public comments on specific aspects of the proposed
information collection as described below. This is a proposed extension
of the ICR, which is currently approved through May 31, 2020. 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.

DATES: Comments must be submitted on or before Friday, November 29,
2019.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OA-
2019-0370 online using www.regulations.gov (our preferred method) or by
mail to: EPA Docket Center, Environmental Protection Agency, Mail Code
28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    The EPA's policy is that all comments received will be included in
the public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information or other information
whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Julie Roemele, NEPA Compliance
Division, Office of Federal Activities, Mail Code 2203A, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, the EPA is soliciting
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. The
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. At that time, the EPA will issue another Federal
Register notice to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB.
    Abstract: The EPA's regulations at 40 CFR part 8, Environmental
Impact Assessment of Nongovernmental Activities in Antarctica (Rule),
were promulgated pursuant to the Antarctic Science, Tourism, and
Conservation Act of 1996 (Act), 16 U.S.C. 2401 et seq., as amended, 16
U.S.C. 2403a, which implements the Protocol on Environmental Protection
(Protocol) to the Antarctic Treaty of 1959 (Treaty). The Rule provides
for assessment of the environmental impacts of nongovernmental
activities in Antarctica, including tourism, for which the United
States is required to give advance notice under Paragraph 5 of Article
VII of the Treaty, and for coordination of the review of information
regarding environmental impact assessments received from other Parties
under the Protocol. The requirements of the Rule apply to operators of
nongovernmental expeditions organized or proceeding from the territory
of the United States to Antarctica and include commercial and non-
commercial expeditions. Expeditions may include ship-based tours;
yacht, skiing or mountaineering expeditions; privately funded research
expeditions; and other nongovernmental activities. The Rule does not
apply to individual U.S. citizens or groups of citizens planning travel
to Antarctica on an expedition for which they are not acting as an
operator. (Operators, for example, typically acquire use of vessels or
aircraft, hire expedition staff, plan itineraries, and undertake other
organizational responsibilities.) The rule provides nongovernmental
operators with the specific requirements they need to meet in order to
comply with the requirements of Article 8 and Annex I to the Protocol.
The provisions of the Rule are intended to ensure that potential
environmental effects of nongovernmental activities undertaken in
Antarctica are appropriately identified and considered by the operator
during the planning process and that to the extent practicable

appropriate environmental safeguards which would mitigate or prevent
adverse impacts on the Antarctic environment are identified by the
operator.
    Environmental Documentation. Persons subject to the Rule must
prepare environmental documentation to support the operator's
determination regarding the level of environmental impact of the
proposed expedition. Environmental documentation includes a Preliminary
Environmental Review Memorandum (PERM), an Initial Environmental
Evaluation (IEE), or a Comprehensive Environmental Evaluation (CEE).
The environmental document is submitted to the Office of Federal
Activities (OFA). If the operator determines that an expedition may
have: (1) Less than a minor or transitory impact, a PERM needs to be
submitted no later than 180 days before the proposed departure to
Antarctica; (2) no more than minor or transitory impacts, an IEE needs
to be submitted no later than 90 days before the proposed departure; or
(3) more than minor or transitory impacts, a CEE needs to be submitted.
Operators who anticipate such activities are encouraged to consult with
EPA as soon as possible regarding the date for submittal of the CEE.
(Article 3(4), of Annex I of the Protocol requires that draft CEEs be
distributed to all Parties and the Committee for Environmental
Protection 120 days in advance of the next Antarctic Treaty
Consultative Meeting at which the CEE may be addressed.)
    The Protocol and the Rule also require an operator to employ
procedures to assess and provide a regular and verifiable record of the
actual impacts of an activity which proceeds on the basis of an IEE or
CEE. The record developed through these measures needs to be designed
to: (a) Enable assessments to be made of the extent to which
environmental impacts of nongovernmental expeditions are consistent
with the Protocol; and (b) provide information useful for minimizing
and mitigating those impacts and, where appropriate, on the need for
suspension, cancellation, or modification of the activity. Moreover, an
operator needs to monitor key environmental indicators for an activity
proceeding based on a CEE. An operator may also need to carry out
monitoring in order to assess and verify the impact of an activity for
which an IEE would be prepared. For activities that require an IEE, an
operator should be able to use procedures currently being voluntarily
utilized by operators to provide the required information. Should an
activity require a CEE, the operator should consult with the EPA to:
(a) Identify the monitoring regime appropriate to that activity, and
(b) determine whether and how the operator might utilize relevant
monitoring data collected by the U.S. Antarctic Program. OFA would
consult with the National Science Foundation and other interested
Federal agencies regarding the monitoring regime.
    In cases of emergency related to the safety of human life or of
ships, aircraft, equipment and facilities of high value, or the
protection of the environment which would require an activity to be
undertaken without completion of the documentation procedures set out
in the Rule, the operator would need to notify the Department of State
within 15 days of any activities which would have otherwise required
preparation of a CEE, and provide a full explanation of the activities
carried out within 45 days of those activities. (During the time the
Interim Final and Final Rules have been in effect, there were no
emergencies requiring notification by U.S. operators. An Interim Final
Rule was in effect from April 30, 1997, until replaced on December 6,
2001, by the Final Rule).
    Environmental documents (e.g., PERM, IEE, CEE) are submitted to
OFA. Environmental documents are reviewed by OFA, in consultation with
the National Science Foundation and other interested Federal agencies
and made available to other Parties and the public as required under
the Protocol or otherwise requested. OFA notifies the public of
document availability via the World Wide Web at: https://www.epa.gov/international-cooperation/receipt-environmental-impact-assessments-eias-regarding-nongovernmental.
    The types of nongovernmental activities currently being carried out
(e.g., ship-based tours, land-based tours, flights, and privately
funded research expeditions) are typically unlikely to have impacts
that are more than minor or transitory, thus an IEE is the typical
level of environmental documentation submitted. For the 1997-1998
through 2018-2019 austral summer seasons during the time the Rule has
been in effect, all respondents submitted IEEs except for three PERMs.
Paperwork reduction provisions in the Rule that are used by the
operators include: (a) Incorporation of material in the environmental
document by referring to it in the IEE, (b) inclusion of all proposed
expeditions by one operator within one IEE; (c) use of one IEE to
address expeditions being carried out by more than one operator; and
(d) use of multi-year environmental documentation to address proposed
expeditions for a period of up to five consecutive austral summer
seasons.
    Coordination of Review of Information Received From Other Parties
to the Treaty. The Rule also provides for the coordination of review of
information received from other Parties and the public availability of
that information including: (1) A description of national procedures
for considering the environmental impacts of proposed activities; (2)
an annual list of any IEEs and any decisions taken in consequence
thereof; (3) significant information obtained and any action taken in
consequence thereof with regard to monitoring from IEEs to CEEs; and
(4) information in a final CEE. This provision fulfills the United
States' obligation to meet the requirements of Article 6 of Annex I to
the Protocol. The Department of State is responsible for coordination
of these reviews of drafts with interested Federal agencies, and for
public availability of documents and information. This portion of the
Rule does not impose paperwork requirements on any nongovernmental
person subject to U.S. regulation.
    Form Numbers: None.
    Respondents/affected entities: Entities potentially affected by
this action are all nongovernmental operators with activities in
Antarctica, including tour operators, for which the United States is
required to give advance notice under paragraph 5 of Article VII of the
Antarctic Treaty of 1959; this includes all nongovernmental expeditions
to and within Antarctica organized in or proceeding from the territory
of the United States.
    Respondent's obligation to respond: Mandatory (40 CFR part 8).
    Estimated number of respondents: 25 (total).
    Frequency of response: Annual.
    Total estimated burden: 1,544 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $133,780 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in Estimates: There is an increase of 330 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This increase is the result of a change to the number
of operators that the EPA anticipates will submit environmental
documentation as well as the inclusion of a potential PERM, CEE and
Emergency Report submitted by every three years.

    Dated: September 24, 2019.
Robert Tomiak,
Director, Office of Federal Activities.
[FR Doc. 2019-21112 Filed 9-27-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 39 (Monday, February 28, 2011)]
[Notices]
[Pages 10908-10909]
[FR Doc No: 2011-4341]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0074]

Draft Guidance for Industry on Medication Guides--Distribution
Requirements and Inclusion of Medication Guides in Risk Evaluation and
Mitigation Strategies; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Medication
Guides--Distribution Requirements and Inclusion in Risk Evaluation and
Mitigation Strategies (REMS).'' This draft guidance addresses two
topics pertaining to Medication Guides for drug and biological
products. First, the draft guidance addresses when FDA intends to
exercise enforcement discretion regarding dispensing requirements for
Medication Guides that must be distributed with a drug or biological
product dispensed to a healthcare professional for administration to a
patient instead of being dispensed directly to the patient for self-
administration or to the patient's caregiver for administration to the
patient. Second, the draft guidance addresses when a Medication Guide
will be required as part of a REMS. The draft guidance is intended to
answer questions that have arisen concerning these topics.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 31, 2011.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The
guidance may also be obtained by mail by calling CBER at 1-800-835-4709
or<PHONE_NUMBER>. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kristen E. Miller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6226, Silver Spring, MD 20993-0002, 301-
796-5400; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Medication Guides--Distribution Requirements and Inclusion
of Medication Guides in Risk Evaluation and Mitigation Strategies
(REMS).'' This draft guidance is intended to address two topics
pertaining to Medication Guides for drug and biological products.
    Medication Guides are primarily for prescription drug and
biological products used on an outpatient basis without direct
supervision by a healthcare professional. Questions have arisen
concerning when a Medication Guide must be distributed with a drug or
biological product dispensed to a healthcare professional for
administration to a patient in certain situations, for example, in an
inpatient setting or an outpatient setting such as a clinic or infusion
center. This draft guidance is intended to articulate the circumstances
under which FDA intends to exercise enforcement discretion regarding
Medication Guide distribution.
    The second topic addressed by the draft guidance is when a
Medication Guide will be required as part of a REMS. Under section 505-
1(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21
U.S.C. 355-1(e)), FDA may require that a REMS for a drug include one or
more of the elements described in section 505-1(e), including (when the
criteria in part 208 (21 CFR part 208) are met), the requirement for an
applicant to develop a Medication Guide for distribution to each
patient when the drug is dispensed. Since the enactment of the Food and
Drug Administration Amendments Act of 2007, FDA has, as a matter of
policy, considered any new Medication Guide (or safety-related changes
to an existing Medication Guide) to be part of a REMS. However, the
Agency has the authority to determine, based on the risks of a drug and
public health concern, how a Medication Guide should be required when
the standard in part 208 is met. Based on the risks and public health
concern, the Agency may require:
    (1) A Medication Guide in accordance with part 208 that is not a
part of a REMS or
    (2) A Medication Guide in accordance with part 208 and section 505-
1 of the FD&C Act that is part of a REMS, which will include other
parts of a REMS (such as the timetable for submission of assessments)
and possibly other REMS elements (including elements to assure safe
use).
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on when FDA
intends to exercise enforcement discretion regarding Medication Guide
distribution and inclusion of Medication Guides in REMS. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statutes and
regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in Sec. Sec.  314.70 and 600.12 have been
approved under OMB control numbers 0910-0001 and 0910-0338; the
collections of information in part 208 have been approved under OMB
control number 0910-0393.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.regulations.gov.

    Dated: February 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-4341 Filed 2-25-11; 8:45 am]
BILLING CODE 4160-01-P