[Federal Register Volume 88, Number 157 (Wednesday, August 16, 2023)]
[Notices]
[Pages 55705-55706]
[FR Doc No: 2023-17510]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3329]

Oncologic Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Oncologic Drugs Advisory
Committee (the Committee). The general function of the Committee is to
provide advice and recommendations to FDA on regulatory issues. The
meeting will be open to the public. FDA is establishing a docket for
public comment on this document.

DATES: The meeting will be held on October 4, 2023, from 9:30 a.m. to 3
p.m. Eastern Time.

ADDRESSES: All meeting participants will be heard, viewed, captioned,
and recorded for this advisory committee meeting via an online
teleconferencing and/or video conferencing platform.
    Answers to commonly asked questions about FDA advisory committee
meetings may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2023-N-3329. The docket will close on October
3, 2023. Please note that late, untimely filed comments will not be
considered. The https://www.regulations.gov electronic filing system
will accept comments until 11:59 p.m. Eastern Time at the end of
October 3, 2023. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
received on or before that date.
    Comments received on or before September 20, 2023, will be provided
to the Committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments as follows:

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-2023-N-3329 for ``Oncologic Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<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.'' FDA 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 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 the 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: Joyce Frimpong, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-

796-7973, email: [email protected], or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last-minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before the
meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing and/or video
conferencing platform. The Committee will discuss new drug application
(NDA) 215500, for eflornithine tablets, submitted by USWM, LLC (doing
business as U.S. WorldMeds). The proposed indication (use) for this
product is to reduce the risk of relapse in pediatric patients with
high-risk neuroblastoma who have completed multiagent, multimodality
therapy.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference and/or video conference meeting will
be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link. The meeting will include slide presentations with audio and video
components to allow the presentation of materials in a manner that most
closely resembles an in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the Committee.
All electronic and written submissions to the Docket (see ADDRESSES) on
or before September 20, 2023, will be provided to the Committee. Oral
presentations from the public will be scheduled between approximately
1:15 p.m. and 2:15 p.m. Eastern Time. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before September 12, 2023. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by September 13, 2023.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Joyce Frimpong (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the location of advisory committee
meetings are hereby waived to allow for this meeting to take place
using an online meeting platform. This waiver is in the interest of
allowing greater transparency and opportunities for public
participation, in addition to convenience for advisory committee
members, speakers, and guest speakers. No participant will be
prejudiced by this waiver, and that the ends of justice will be served
by allowing for this modification to FDA's advisory committee meeting
procedures.

    Dated: August 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17510 Filed 8-15-23; 8:45 am]
BILLING CODE 4164-01-P


the Commission's conclusion that interstate pipelines should be able to
discount to compete with intrastate pipelines. Northern Municipals
state that with regard to the CenterPoint discount discussed above, the
competition that Northern was attempting to meet was from a new
intrastate pipeline to be built. Northern Municipals state that if the
pipeline had been built, it would have freed-up capacity in Northern's
capacity constrained market area perhaps provided access to new or
additional supply sources and increased competitive alternatives.
    115. In the May 31 Order the Commission stated that as the national
transportation grid becomes more competitive, there will be fewer
captive customers. The Commission believes that its policies promoting
competition do encourage pipelines to compete for business, including
the business of captive customers, and since Order No. 636, substantial
new capacity has been built.\82\ In any event, as we have

explained above, issues concerning Northern's discount to CenterPoint
can be considered in Northern's next rate case.
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    \82\ As stated above, in response to a 2005 INGAA survey, 36
pipelines reported that they had spent $19.6 billion for interstate
pipeline infrastructure between 1993 and 2004, and during the 1990s
interregional natural gas pipeline capacity grew by 27 percent.
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    116. IMGA further states that while the Commission stated that it
would consider the impact of discount adjustments in specific
proceedings, IMGA and other captive customers have been paying higher
rates than necessary and lawful because of the Commission's discount
policy for the past 16 years and absent Commission action now, will
continue to pay those unlawful rates. Contrary to this assertion, the
current rates being paid by IMGA are lawful rates that have been found
just and reasonable under section 4 of the NGA.

H. Periodic Rate Cases

    117. The May 31 Order found that selective discounting does not
provide a basis for requiring pipelines to file periodic rate cases.
The Commission explained that, unlike the circumstances under the
Commission's Purchased Gas Adjustment (PGA) clause regulations there is
no adjustment mechanism that permits a pipeline to change its rates and
pass additional costs through to customers between rate cases. The
Commission found that in these circumstances, the procedures under
sections 4 and 5 of the NGA provide sufficient protections to the
pipeline's customers.
    118. On rehearing, Northern Municipals argue that if a pipeline
increases throughput through discounting, any resulting benefits will
not accrue to captive customers until the throughput on which rates are
based is adjusted in a rate case to reflect the increase. Further,
Northern Municipals state that without a requirement for periodic
section 4 rate filings, pipelines have the ability to manipulate the
timing of their filings to maximize revenue. Northern Municipals also
assert that current system rates most likely already include discount
adjustments and that, to the extent that those adjustments were based
on discounts that no longer accurately reflect the current level of
discounting, they may or may not achieve the purposes of the selective
discounting policy.
    119. Further, Northern Municipals state complaint proceedings are
not a solution because they are time consuming and expensive, the party
filing the complaint will not have access to the information needed to
file the complaint in the first place, and relief is prospective only.
Northern Municipals state that in their initial comments, they asked
the Commission to ask Congress to amend section 5 of the NGA to provide
for refunds. Northern Municipals state that the May 31 Order does not
address these shortcomings of section 5 and argues that the Commission
must fully address these issues before concluding that section 5
provides sufficient protection to consumers.
    120. Under section 4 of the NGA, the Commission is required to
ensure that rate changes proposed by the pipeline are just and
reasonable, and under section 5, if the Commission finds that the
existing rate is unjust or unreasonable, it must establish the just and
reasonable rate for the future. This is the statutory scheme under the
NGA and it gives the Commission sufficient authority to ensure that
pipeline rates are just and reasonable. A requirement that pipelines
file periodic rate cases is not part of the statutory scheme, and the
Commission's authority to require such filings is limited.\83\ As the
Commission stated in the May 31 Order, under this statutory scheme, the
decision to file a rate case is always that of the pipeline and it may
choose to file a rate at a time that it is advantageous for it to do
so. The ``shortcomings'' Northern Municipals perceives in section 5 as
a remedy are part of the statutory scheme. The fact that under section
5 the burden of proof is on the complainant and that relief is
prospective only does not give the Commission authority to order
periodic rate filings under section 4.
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    \83\ New York State Public Service Commission v. FERC, 866 F.2d
487 (D.C. Cir.1989) (requiring periodic filings under NGA section 4
beyond the Commission's statutory authority).
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    121. Northern Municipals argue that periodic rate filings should be
required because there are similarities between the discount policy and
the PGA. Northern Municipals state that the fundamental premise behind
the periodic rate filing required under the PGA regulations was that,
in exchange for the ability to change only one cost element, pipelines
agreed to a re-examination of all their costs and rates at three-year
intervals to assure that the gas cost increases were not offset by
decreases in other costs. Northern Municipals state that, similarly,
the premise of selective discounting is that captive customers will
benefit from subsidizing discounts because there will be an increase in
fixed costs spreading. But, they argue, if the discounts are not
reviewed periodically, any alleged benefits may not be realized.
Northern Municipals assert that this is no different in principle from
saying that the pipeline under a PGA clause must examine all costs at
regular intervals to assure that the gas cost increases were not offset
by decreases in other costs.
    122. The Commission affirms its conclusion that similarities
between the PGA mechanism and the discount adjustment mechanism do not
justify a periodic rate filing requirement. Under the PGA mechanism,
pipelines were able to pass projected changes in their gas costs
through to customers between rate cases. Thus, the rates adjudicated
just and reasonable in a section 4 rate case would change prior to the
next rate case to reflect increased gas costs. In exchange for this
ability to increase their rates between rate cases, the pipelines
agreed to a reexamination of all of their rates at three-year
intervals. This is not analogous to the discount adjustment permitted
in the pipeline's next rate case to reflect that not all test-period
throughput volumes were transported at the maximum rate. There is no
mechanism under the selective discount policy that permits shippers'
rates to change between rate cases. The rates of other shippers on the
system remain at the level determined to be just and reasonable in the
pipeline's last section 4 rate case and are not affected until the next
rate case is filed. In these circumstances a requirement that pipelines
file periodic rate cases is not justified.

I. Informational Posting Requirements

    123. In the May 31 Order, the Commission concluded that its current
informational posting requirements provide shippers with the price
transparency needed to make informed decisions and to monitor
transactions for undue discrimination and preference.\84\ Therefore,
the Commission stated that it would not change its informational
posting requirements at this time. The Commission further stated that
it will refer allegations of non-compliance with the Commission's
posting and reporting requirements to the Office of Market Oversight
and Investigation for a potential audit and that, as part of the
Commission's ongoing market

monitoring program, the Commission will continue to conduct audits on
its own.
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    \84\ Under section 284.13(b), pipelines are required to post on
their Web site information concerning any discounted transactions,
including the name of the shipper, the maximum rate, the rate
actually charged, the volumes, receipt and delivery points, the
duration of the contract, and information on any affiliation between
the shipper and the pipeline. Further, section 358.5(d) of the
regulations requires pipelines to post on their Web site any offer
of a discount at the conclusion of negotiations contemporaneous with
the time the offer is contractually binding.
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    124. Northern Municipals argue that the Commission erred in
refusing to amend its regulations to require pipelines to post the
reasons for each selective discount granted and the benefits of the
discount to captive customers. They state that if customers want to
oppose a discount, they must know the reason for it. Northern
Municipals state that attempting to analyze a pipeline's reasons for
granting the discount in a later-filed rate case raises additional
issues, including whether after-the-fact justification should be
permitted and whether it is more difficult for the captive customers to
eliminate discount adjustments for discounts that have already been
provided to favored customers.
    125. As explained in the May 31 Order, under section 284.13(b) of
the Commission's regulations, pipelines are required to post on their
Web site information concerning any discounted transactions, including
the name of the shipper, the maximum rate, the rate actually charged,
the volumes, receipt and delivery points, the duration of the contract,
and information on any affiliation between the shipper and the
pipeline. Further, section 358.5(d) of the regulations requires
pipelines to post on their Web site any offer of a discount at the
conclusion of negotiations contemporaneous with the time the offer is
contractually binding. This information provides shippers and the
Commission with the price transparency needed to make informed
decisions and to monitor transactions for undue discrimination and
preference. As the court stated in AGD I,\85\ ``the reporting system
will enable the Commission to monitor behavior and to act promptly when
it or another party detects behavior arguably falling under the bans of
sections 4 and 5.''
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    \85\ 824 F.2d at 1009.
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    126. In determining whether a discount adjustment is appropriate in
a rate case, the Commission determines whether the discount was
required by competition at the time it was given. Thus, the competitive
circumstances at the time of the discount are relevant and an ``after-
the-fact'' justification that does not meet that standard would not
support a discount adjustment. Nor would it be more difficult under
this standard to ``eliminate discount adjustments for discounts that
have already been provided to favored customers.'' Therefore, the
request for rehearing is denied. The Commission will not change its
informational posting requirements at this time.

J. Proceeding To Investigate New Cost Allocation Methodologies

    127. Northern Municipals state that in the NOI the Commission
requested comments on what alternative changes in the Commission's
policy could be considered to minimize any adverse effects on captive
customers. Northern Municipals state that in response, it requested
that the Commission institute proceedings to investigate a new cost
allocation methodology that would more fairly allocate the costs of the
pipeline system in proportion to the benefits a shipper derives from
the system. Northern Municipals state that the Commission erred in not
addressing this issue and asks the Commission address its alternative
proposal on rehearing.
    128. Northern Municipals ask the Commission to consider and
investigate a new approach to pipeline regulation that would mandate
structural separation of the pipeline networks from their parent
corporations and affiliates. Under Northern Municipals' proposal, the
pipeline network would be independently financed, would have its own
board of directors, and would have common carrier status. Further,
Northern Municipals state that the Commission should utilize a cost
allocation methodology that assigns the costs of the interstate
pipeline network to customers in direct proportion to the benefits that
they derive from the use of the network. Northern Municipals also ask
the Commission to consider implementing an independent system operator
(ISO) similar to that in the electric industry.
    129. In the NOI, the Commission sought comments on what alternative
changes in the Commission's discount adjustment policy could be
considered to minimize any adverse effect on captive customers. The
issues raised by Northern Municipals are beyond the scope of this
proceeding \86\ and the Commission will not address them here.
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    \86\ Some of the proposals also appear to be beyond the scope of
the Commission's authority to implement.
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    The Commission orders: The requests for rehearing are denied.

    By the Commission. Commissioner Kelly dissenting in part with a
separate statement attached.
Magalie R. Salas,
Secretary.
Kelly, Commissioner, dissenting in part:

    As I stated in the underlying order in this proceeding,\1\ I
would have supported a requirement for pipelines to post on their
Web sites the reasons for providing a selective discount to a
particular shipper. Therefore, I respectfully dissent in part on
this order.

    \1\ Policy for Selective Discounting By Natural Gas Pipelines,
111 FERCSec.  61,309 (2005).
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     Suedeen G. Kelly
[FR Doc. 05-23140 Filed 11-22-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 49 (Monday, March 14, 2022)]
[Notices]
[Pages 14260-14261]
[FR Doc No: 2022-05254]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL 9597-01-OA]

Request for Nominations of Candidates for the National
Environmental Education Advisory Council (NEEAC)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The U.S. Environmental Protection Agency (EPA or Agency Office
of Public Engagement and Environmental Education is soliciting
applications for environmental education professionals for
consideration to serve on the National Environmental Education Advisory
Council (NEEAC). There are multiple vacancies on the Advisory Council
that must be filled. Additional avenues and resources may be utilized
in the solicitation of applications. ``In accordance with Executive
Order 14035 (June 25, 2021), EPA values and welcomes opportunities to
increase diversity, equity, inclusion and accessibility on its federal
advisory committees. EPA's federal advisory committees have a workforce
that reflects the diversity of the American people.''

DATES: Nominations should be submitted by April 13, 2022 per the
instructions below.

FOR FURTHER INFORMATION CONTACT: Any member of the public wishing
further information regarding this Notice and Request for Nominations
may contact Mr. Javier Araujo, Designated Federal Officer (DFO), Office
of Environmental Education (OEE), by telephone at<PHONE_NUMBER> or via
email at [email protected]. General information concerning the
NEEAC can be found on the following website: https://www.epa.gov/education/national-environmental-education-advisory-council-neeac.

SUPPLEMENTARY INFORMATION:

Background

    The National Environmental Education Act requires that the council
be comprised of (11) members appointed by the Administrator of the EPA.
Members represent a balance of perspectives, professional
qualifications, and experience. The Act specifies that members must
represent the following sectors: Primary and secondary education (One
of whom shall be a classroom teacher), two members: Colleges and
universities, two members; business and industry, two members; non-
profit organizations, two members. state departments of education and
natural resources, two members, and one member to represent senior
Americans. Members are chosen to represent various geographic regions
of the country, and the Council strives for a diverse representation.
The professional backgrounds of Council members should include
education, science, policy, or other appropriate disciplines. Each
member of the Council shall hold office for a one (1) to three (3) year
period. Members are expected to participate in up to two (2) meetings
per year and monthly or more conference calls per year. Members of the
council shall receive compensation and allowances, including travel

expenses at a rate fixed by the Administrator.
    Request for Nominations: Specific experience in environmental
justice and climate change education is essential.
    Expertise Sought: The NEEAC staff office seeks candidates with
demonstrated experience and or knowledge in any of the following
environmental education issue areas: (a) Integrating environmental
education into state and local education reform, improvement and
environmental justice initiatives; (b) state, local and tribal level
capacity building for environmental education; (c) cross-sector
partnerships to foster environmental education in Minority Serving
Institutions and increase the conversation around using EE as a tool to
achieve environmental justice, climate equity, and economic prosperity;
(d) leveraging resources for environmental education in underserved
communities; (e) design and implementation of environmental education
research; (f) evaluation methodology; professional development for
teachers and other education professionals; and targeting under-
represented audiences, including low-income, multi-cultural, senior
citizens and other adults.
    The NEEAC is best served by a structurally and geographically
diverse group of individuals. Each individual will demonstrate the
ability to make a time commitment. In addition, the individual will
demonstrate both strong leadership and analytical skills. Also, strong
writing skills, communication skills and the ability to evaluate
programs in an unbiased manner are essential. Team players, who can
meet deadlines and review items on short notice are ideal candidates.

Process and Deadline for Submitting Nominations

    Any interested and qualified individuals may be considered for
appointment on the National Environmental Education Advisory Council.
In order to apply, the following four items should be submitted in
electronic format to the Designated Federal Officer, Javier Araujo,
[email protected] and contain the following: (1) Contact
information including name, address, phone, and an email address; (2) a
curriculum vitae or resume; (3) Include the specific area of expertise
in environmental education and the sector in the subject line of your
email submission; and (4) a one page commentary on the applicant's
philosophy regarding the need for, development, implementation and or
management of environmental education.
    Nominations should be submitted by April 4, 2022.
    Submit nominations electronically to Javier Araujo, Designated
Federal Officer, National Environmental Education Advisory Council,
U.S. Environmental Protection Agency, email: [email protected].

FOR FURTHER INFORMATION CONTACT: For information regarding this Request
for Nominations, please contact Mr. Javier Araujo, Designated Federal
Officer, by email at: [email protected] or phone at:<PHONE_NUMBER>.
General Information concerning NEEAC can be found on the EPA website
at: https://www.epa.gov/education/national-environmental-education-advisory-council-neeac. The short list candidates will be required to
fill out the Confidential Disclosure Form for Special Government
Employees serving Federal Advisory Committees at the U.S. Environmental
Protection Agency. (EPA form 3110-48). This confidential form allows
government officials to determine whether there is a statutory conflict
between that person's public responsibilities (which include membership
on a Federal Advisory Committee) and private interests and activities
and the appearance of a lack of impartiality as defined by Federal
regulation. The form may be viewed and downloaded from the following
URL address. Please note this form is not an application form. http://intranet.epa.gov/ogc/ethics/EPA3110-48ver3.pdf.

Rosemary Enobakhare,
Associate Administrator, Office of Public Engagement and Environmental
Education.
[FR Doc. 2022-05254 Filed 3-11-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 7 (Wednesday, January 11, 2023)]
[Proposed Rules]
[Pages 1528-1532]
[FR Doc No: 2023-00354]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0995]
RIN 1625-AA00

Safety Zones in Reentry Sites; Panama City, Pensacola, and
Tallahassee, Florida

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: This proposed rule would implement a special activities
provision of the William M. (Mac) Thornberry National Defense
Authorization Act for Fiscal Year 2021. The Coast Guard is proposing to
establish three temporary safety zones for the safe splashdown and
recovery of reentry vehicles launched by Space Exploration Technologies
Corporation (SpaceX) in support of National Aeronautics and Space
Administration (NASA) missions. The proposed temporary safety zones are
located within the Coast Guard District Eight area of responsibility
(AOR) offshore of Panama City, Pensacola, and Tallahassee, Florida.
These proposed temporary safety zones are also located specifically
within the Coast Guard Sector Mobile AOR. This proposed rule would
prohibit U.S.-flagged vessels from entering any of the temporary safety
zones unless authorized by the Commanding Officer of Coast Guard Sector
Mobile or a designated representative. Foreign-flagged vessels would be
encouraged to remain outside the safety zones. This action is necessary
to protect vessels and waterway users from the potential hazards
created by reentry vehicle splashdowns and recovery operations in the
U.S. Exclusive Economic Zone (EEZ). It is also necessary to provide for
the safe recovery of reentry vehicles, and any personnel involved in
reentry services, after the splashdown. We invite your comments on this
proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before February 10, 2023.

ADDRESSES: You may submit comments identified by docket number USCG-
2022-0995 using the Federal Decision Making Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Lieutenant Andrew Anderson Sector
Mobile Waterways Division (dpw), U.S. Coast Guard; telephone: 251-441-
5940, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

AOR Area of Responsibility
BNM Broadcast Notice to Mariners
CFR Code of Federal Regulations
DHS Department of Homeland Security
EEZ Exclusive Economic Zone
FAA Federal Aviation Administration
FL Florida
FR Federal Register
MSIB Marine Safety Information Bulletin
NASA National Aeronautics and Space Administration
NM Nautical Mile
NOE Notice of Enforcement
NPRM Notice of Proposed Rulemaking
Sec.  Section
SpaceX Space Exploration Technologies Corporation
U.S. United States
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On January 1, 2021, the William M. (Mac) Thornberry National
Defense Authorization Act for Fiscal Year 2021 (Pub. L. 116-283)
(Authorization Act) was enacted. Section 8343 (134 Stat. 4710) calls
for the Coast Guard to conduct a two-year pilot program to establish
and implement a process to establish safety zones to address special
activities in the U.S. Exclusive Economic Zone (EEZ).\1\ These special
activities include space activities \2\ carried out by United States
(U.S.) citizens. Terms used to describe space activities, including
launch, reentry site, and reentry vehicle, are defined in 51 U.S.C.
50902, and in this document.
---------------------------------------------------------------------------

    \1\ The Coast Guard defines the U.S. exclusive economic zone in
33 CFR 2.30(a). Territorial sea is defined in 33 CFR 2.22.
    \2\ Space Activities means space activities, including launch
and reentry, as such terms are defined in section 50902 of Title 51,
United States Code, carried out by United States citizens.
---------------------------------------------------------------------------

    The Coast Guard has long monitored space activities impacting the
maritime domain and taken actions to ensure the safety of vessels and
the public as needed during space launch \3\ operations. In conducting
this activity, the Coast Guard engages with other government agencies,
including the Federal Aviation Administration (FAA) and National
Aeronautics and Space Administration (NASA), and private space
operators, including Space Exploration Technologies Corporation
(SpaceX). This engagement is necessary to ensure statutory and
regulatory obligations are met to ensure the safety of launch
operations and waterway users.
---------------------------------------------------------------------------

    \3\ The term launch is defined in 51 U.S.C. 50902.
---------------------------------------------------------------------------

    During this engagement, the Coast Guard was informed of space
reentry vehicles and recovery operations in the U.S. EEZ. Section 50902
of 51 U.S.C. defines ``reentry vehicle'' as a vehicle designed to
return from Earth orbit or outer space to Earth, or a reusable launch
vehicle designed to return from Earth orbit or outer space to Earth,
substantially intact. SpaceX, a U.S. company, has identified three
reentry sites \4\ within the U.S. EEZ of the Coast Guard District Eight
area of responsibility (AOR) expected to be used for the splashdown \5\
and recovery of reentry vehicles. All of these sites are located in the
Gulf of Mexico off the coast of Florida (FL).
---------------------------------------------------------------------------

    \4\ Reentry site means the location on Earth to which a reentry
vehicle is intended to return (as defined in a license the FAA
Administrator issues or transfers under this chapter).
    \5\ Splashdown refers to the landing of a reentry vehicle into a
body of water.
---------------------------------------------------------------------------

    On May 4, 2022, we published a temporary final rule in the Federal
Register (87 FR 26273) for two anticipated reentry vehicle recovery
missions within the Coast Guard District Eight AOR offshore of Panama
City, Pensacola, and Tallahassee, FL from April 17, 2022 through May
15, 2022. Based on the date the Coast Guard was informed of the
reentry, and the immediate need to establish the safety zone, the Coast
Guard did not have sufficient time to publish a notice of proposed
rulemaking (NPRM) for that rule. The Coast Guard additionally published
recovery mission temporary final rules for the periods from August 22,
2022 through September 30, 2022 (87 FR 51253) and October 12, 2022
through November 10, 2022 (87 FR 61508).
    The purpose of this rulemaking is to ensure the protection of
vessels and waterway users in the U.S. EEZ from the potential hazards
created by reentry vehicle splashdowns and recovery operations, and the
safe recovery of reentry vehicles and personnel involved in reentry
services.\6\ The Coast Guard is proposing this rulemaking under
authority of section 8343 of the Authorization Act.
---------------------------------------------------------------------------

    \6\ Reentry Services means (1) activities involved in the
preparation of a reentry vehicle and payload, crew (including crew
training), government astronaut, or space flight participant, if
any, for reentry; and (2) the conduct of a reentry.
---------------------------------------------------------------------------

III. Discussion of Proposed Rule

    The Coast Guard is proposing to establish three temporary safety
zones in the U.S. EEZ for the safe reentry vehicle splashdown and
recovery of reentry vehicles launched by SpaceX in support of NASA
missions through the remainder of the pilot period, which ends on
February 4, 2024.
    The proposed temporary safety zones are located within the Coast
Guard District Eight AOR offshore of Panama City, Pensacola, and
Tallahassee, FL in the Gulf of Mexico. The proposed rule would prohibit
U.S.-flagged vessels from entering any of the safety zones unless
authorized by the Commanding Officer of Coast Guard Sector Mobile or a
designated representative. Because the safety zones are within the U.S.
EEZ, only U.S.-flagged vessels would be subject to enforcement.
However, all foreign-flagged vessels would be encouraged to remain
outside the safety zones.
    The three proposed temporary safety zones are located off the coast
of FL in the Gulf of Mexico in the following areas: (1) Approximately
30 NM southwest from Pensacola; (2) 26 NM southwest from Panama City;
and 40 NM south of Tallahassee. All three safety zones have an
approximate area of 100 square miles and are in the shape of a square.
    The coordinates for the safety zones are based on the furthest
north, east, south, and west points of the reentry vehicles splashdown
and are determined from data and modeling by SpaceX and NASA. The
coordinates take into account the trajectories of the reentry vehicles
coming out of orbit, the potential risk to the public, and the
proximity to medical facilities that meet NASA requirements. The
specific coordinates for the three temporary safety zones are presented
in the regulatory text at the end of this document.
    To the extent feasible, the Sector Commander or a designated
representative would inform the public of the activation of the three
temporary safety zones by Notice of Enforcement (NOE) published in the
Federal Register at least two days before the reentry vehicle
splashdown. The NOE would identify the approximate date(s) during which
a reentry vehicle splashdown and recovery operations would occur.
    To the extent possible, twenty-four hours before a reentry vehicle
splashdown and recovery operations, the Sector Commander or designated
representative would inform the public that only one of the three
safety zones would remain activated (subject to enforcement) until
announced by Broadcast Notice to Mariners (BNM) on VHF-FM channel 16,
and/or Marine Safety Information Bulletin (MSIB) (as appropriate) that
the safety zone is no longer subject to enforcement. The specific
temporary safety zone to be enforced would be based on varying mission
and environmental factors, including atmospheric conditions, sea state,
weather, and orbital calculations.
    The MSIB would include the geographic coordinates of the activated

safety zone, a map identifying the location of the activated safety
zone, and information related to potential hazards associated with a
reentry vehicle splashdown and recovery operations associated with
space activities, including marine environmental and public health
hazards, such the release of hydrazine and other potential oil or
hazardous substances.
    When the safety zone is activated, the Sector Commander or a
designated representative would be able to restrict U.S.-flagged vessel
movement including but not limited to transiting, anchoring, or mooring
within the safety zone to protect vessels from hazards associated with
space activities. The activated safety zone would ensure the protection
of vessels and waterway users from the potential hazards created by
reentry vehicle splashdowns and recovery operations. This includes
protection during the recovery of a reentry vehicle, and the protection
of personnel involved in reentry services and space support vessels.\7\
---------------------------------------------------------------------------

    \7\ Space Support Vessel means any vessel engaged in the support
of space activities. These vessels are typically approximately 170
feet in length, have a forward wheelhouse, and are equipped with a
helicopter pad and lifting crane.
---------------------------------------------------------------------------

    After a reentry vehicle splashdown, the Sector Commander or a
designated representative would grant general permission to come no
closer than 3 NM within the activated safety zone from any reentry
vehicle or space support vessel engaged in the recovery operations. The
recovery operations are expected to last approximately one hour. That
should allow for sufficient time to let any potential toxic materials
clear the reentry vehicle, recovery of the reentry vehicle by the space
support vessel, and address any potential medical evacuations for any
personnel involved in reentry services that were onboard the reentry
vehicle.
    Once a reentry vehicle and any personnel involved in reentry
services are removed from the water and secured onboard a space support
vessel, the Sector Commander or designated representative would issue a
BNM on VHF-FM channel 16 announcing the activated safety zone is no
longer subject to enforcement. A photograph of a reentry vehicle and
space support vessel expected to use the reentry sites are available in
the docket.

IV. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on the size,
location, duration, and scope of the temporary safety zones. The
temporary safety zones are limited in size and location to only those
areas where reentry vehicles splashdown and recovery operations occur.
The safety zones are limited in scope, as vessel traffic would be able
to safely transit around the activated safety zone which will only
impact a small part of the U.S. EEZ within the Gulf of Mexico. The
proposed rule involves the establishment of three temporary safety
zones which would be activated two days before a reentry vehicle
splashdown and recovery operations. Twenty-four hours before a reentry
vehicle splashdown, one of the three temporary safety zones would
remain active. After a reentry vehicle splashdown, general permission
would be granted to come no closer than 3 NM within the activated
safety zone. There is a danger associated with fumes from the reentry
vehicle after it has splashed down. Once a reentry vehicle and any
personnel involved in reentry services are removed from the water and
secured onboard a space support vessel, the activated safety zone would
no longer be subject to enforcement. The activated safety zone would
ensure the protection of vessels and waterway users from the potential
hazards created by a reentry vehicle splashdown and recovery operations
and the recovery of a reentry vehicle, personnel involved in reentry
services, and space support vessel.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    The safety zones are only expected to last a few hours from reentry
vehicle splashdown to recovery. Vessels will be able to transit around
the activated safety zone location during these recoveries. We do not
anticipate any significant economic impact resulting from activation of
the safety zones.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity, and that this proposed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES) explaining why you think it qualifies and how and to
what degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the proposed rule
would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please call or email the person listed in the
FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not
retaliate against small entities that question or complain about this
proposed rule or any policy or action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

Federal Government and Indian tribes. If you believe this proposed rule
has implications for federalism or Indian tribes, please call or email
the person listed in the FOR FURTHER INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves the
establishment of three temporary safety zones which would be activated
two days before a reentry vehicle splashdown and recovery operations.
Twenty-four hours before a reentry vehicle splashdown, one of the three
temporary safety zones would remain active. After a reentry vehicle
splashdown, general permission would be granted to come no closer than
3 NM within the activated safety zone. Once a reentry vehicle and any
personnel involved in reentry services are removed from the water and
secured onboard a space support vessel, the activated safety zone would
no longer be subject to enforcement. Normally such actions are
categorically excluded from further review under paragraph L60(a) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A
preliminary Record of Environmental Consideration supporting this
determination is available in the docket. For instructions on locating
the docket, see the ADDRESSES section of this preamble. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

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

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    Submitting comments. We encourage you to submit comments through
the Federal Decision Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2022-0995 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER
INFORMATION CONTACT section of this proposed rule for alternate
instructions.
    Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov Frequently Asked
Questions web page. We review all comments received, but we will only
post comments that address the topic of the proposed rule. We may
choose not to post off-topic, inappropriate, or duplicate comments that
we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
to the docket in response to this document, see DHS's eRulemaking
System of Records notice (85 FR 14226, March 11, 2020).

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard is
proposing to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  46 U.S.C. 70034, 70051, 70124; section 8343 of Pub.
L. 116-283, 134 Stat. 3388, 4710; 33 CFR 1.05-1, 6.04-1, 6.04-6, and
160.5; Department of Homeland Security Delegation No. 00170.1,
Revision No. 01.3.

0
2. Add Sec.  165.T08-0995 to read as follows:

Sec.  165.T08-0995   Safety Zones in Reentry Sites; Panama City,
Pensacola, and Tallahassee, Florida.

    (a) Location. The coordinates used in this paragraph are based on
the World Geodetic System (WGS) 1984. The following areas are safety
zones:
    (1) Panama City Site. All waters from surface to bottom encompassed
within a line connecting the following points: Point 1, thence to Point
2, thence to Point 3, thence to Point 4, and then back to Point 1.

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

------------------------------------------------------------------------
Point 1.......................  29[deg]47'46'' N    086[deg]16'44'' W
Point 2.......................  29[deg]47'46'' N    086[deg]05'20'' W
Point 3.......................  29[deg]37'48'' N    086[deg]16'44'' W
Point 4.......................  29[deg]37'48'' N    086[deg]05'20'' W
------------------------------------------------------------------------

    (2) Pensacola. All waters from surface to bottom encompassed within
a line connecting the following points: Point 1, thence to Point 2,
thence to Point 3, thence to Point 4, and then back to Point 1.

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

------------------------------------------------------------------------
Point 1.......................  29[deg]53'02'' N    087[deg]35'46'' W
Point 2.......................  29[deg]53'02'' N    087[deg]24'14'' W
Point 3.......................  29[deg]42'58'' N    087[deg]35'46'' W
Point 4.......................  29[deg]42'58'' N    087[deg]24'14'' W
------------------------------------------------------------------------

    (3) Tallahassee Site. All waters from surface to bottom encompassed
within a line connecting the following points: Point 1, thence to Point
2, thence to Point 3, thence to Point 4, and then back to Point 1.

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

------------------------------------------------------------------------
Point 1.......................  29[deg]21'47'' N    084[deg]17'46'' W
Point 2.......................  29[deg]21'47'' N    084[deg]06'18'' W
Point 3.......................  29[deg]11'46'' N    084[deg]17'46'' W
Point 4.......................  29[deg]11'46'' N    084[deg]06'18'' W
------------------------------------------------------------------------

    (b) Definitions. As used in this section--
    Designated representative means a Coast Guard Patrol Commander,
including a Coast Guard coxswain, petty

officer, or other officer operating a Coast Guard vessel; Coast Guard
Representatives in the Merrill Operations Center; and other officers
designated by the Sector Commander of Coast Guard Sector Mobile.
    Sector Commander means Commander of Coast Guard Sector Mobile.
    Reentry Services means (1) activities involved in the preparation
of a reentry vehicle and payload, crew (including crew training),
government astronaut, or space flight participant, if any, for reentry;
and (2) the conduct of a reentry.
    Reentry vehicle means a vehicle designed to return from Earth orbit
or outer space to Earth, or a reusable launch vehicle designed to
return from Earth orbit or outer space to Earth, substantially intact.
    Space Support Vessel means any vessel engaged in the support of
space activities. These vessels are typically approximately 170 feet in
length, have a forward wheelhouse, and are equipped with a helicopter
pad and lifting crane.
    Splashdown means the landing of a reentry vehicle into a body of
water.
    (c) Regulations. (1) Because the safety zones described in
paragraph (a) of this section are within the U.S. Exclusive Economic
Zone, only U.S.-flagged vessels are subject to enforcement. All
foreign-flagged vessels are encouraged to remain outside the safety
zones.
    (2) In accordance with the general regulations in 33 CFR part 165,
subpart C, no U.S.-flagged vessel may enter the safety zones described
in paragraph (a) of this section unless authorized by the Sector
Commander or a designated representative, except as provided in
paragraph (d)(3).
    (d) Notification of Enforcement. (1) To the extent feasible, the
Sector Commander or a designated representative will inform the public
of the activation of the three safety zones described in paragraph (a)
of this section by Notice of Enforcement published in the Federal
Register at least two days before the splashdown.
    (2) To the extent possible, twenty-four hours before a reentry
vehicle splashdown, the Sector Commander or designated representative
will inform the public that only one of the three safety zones
described in paragraph (a) will remain activated until announced by
Broadcast Notice to Mariners on VHF-FM channel 16, and/or Marine Safety
Information Bulletin (as appropriate) that the safety zone is no longer
subject to enforcement.
    (3) After a reentry vehicle splashdown, the Sector Commander or a
designated representative will grant general permission to come no
closer than 3 nautical miles of any reentry vehicle or space support
vessel engaged in the recovery operations, within the activated safety
zone described in paragraph (a) of this section.
    (4) Once a reentry vehicle, and any personnel involved in reentry
service, are removed from the water and secured onboard a space support
vessel, the Sector Commander or designated representative will issue a
Broadcast Notice to Mariners on VHF-FM channel 16 announcing the
activated safety zone is no longer subject to enforcement.
    (e) Effective period. This section is effective from [EFFECTIVE
DATE OF FINAL RULE] through February 4, 2024.

    Dated: January 5, 2023.
Ulysses S. Mullins,
Captain, Commander, Coast Guard Sector Mobile, Captain of the Port
Mobile.
[FR Doc. 2023-00354 Filed 1-10-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 124 (Friday, June 26, 2020)]
[Notices]
[Pages 38378-38380]
[FR Doc No: 2020-13749]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1459]

Generic Drug User Fee Amendments; Public Meeting; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
hosting a virtual public meeting entitled ``Generic Drug User Fee

Amendments (GDUFA) of 2017.'' At the end of September 2022, new
legislation will be required for FDA to continue to collect generic
drug user fees for future fiscal years. The Federal Food, Drug, and
Cosmetic Act (FD&C Act) requires that before FDA begins negotiations
with the regulated industry on GDUFA reauthorization, we publish a
notice in the Federal Register requesting public input on the
reauthorization, hold a public meeting at which the public may present
its views on the reauthorization, including specific suggestions for
changes to the goals referred to in the GDUFA Reauthorization
Performance Goals and Program Enhancements Fiscal Years 2018-2022
(i.e., the GDUFA II Commitment Letter), provide a period of 30 days
after the public meeting to obtain written comments from the public,
and publish the comments on FDA's website. FDA invites public comment
on the GDUFA program and suggestions regarding the features FDA should
propose for the next GDUFA program cycle. These comments will be
published and available on FDA's website.

DATES: The public meeting will be held on July 21, 2020, from 8:30 a.m.
to 3:30 p.m., and will take place virtually and will be held by webcast
only. Submit either electronic or written comments on this public
meeting by August 20, 2020. See the SUPPLEMENTARY INFORMATION section
for registration date and information.
    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 August 20, 2020. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of August 20, 2020. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-N-1459 for ``Generic Drug User Fee Amendments; Public Meeting;
Request for Comments.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday,<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>,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Tiana Barnes, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6196, Silver Spring, MD 20993, 301-796-
2882<EMAIL_ADDRESS>or Dat Doan, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 3334, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, the Food and Drug Administration Safety and
Innovation Act, which included GDUFA (Pub. L. 112-144, Title III), was
signed into law by the President. In 2017, the GDUFA program was
reauthorized (GDUFA II) under the FDA Reauthorization Act of 2017 (Pub.
L. 115-52, Title III), which authorizes FDA to collect fees for certain
generic human drug applications, drug master files, and facilities.
Designed to speed access to safe and effective generic drugs to the
public, GDUFA II requires that generic drug manufacturers and other
relevant entities pay user fees to finance critical and measurable
generic drug program enhancements. As described in the GDUFA II
Commitment Letter, FDA committed to achieve certain performance goals,
provide enhanced communication intended to streamline abbreviated new
drug application (ANDA) development and assessment, and take other
steps to increase the efficiency of the assessment process.

GDUFA II also includes a pre-ANDA program to clarify regulatory
expectations for complex generic product developers early in product
development and during application review.
    Additional information concerning GDUFA, including the text of the
law, the GDUFA II Commitment Letter, key Federal Register documents,
GDUFA-related guidances, performance reports, and financial reports may
be found on the FDA website at https://www.fda.gov/gdufa.

II. Topics for Discussion at the Public Meeting

    FDA is interested in responses to the following general questions:

     What is your assessment of the overall performance of the
GDUFA program to date?
     What aspects of GDUFA should be retained, changed, or
discontinued to further strengthen and improve the program?
     What new features should FDA consider adding to the
program to enhance efficiency and effectiveness of the generic drug
review process?

    FDA welcomes any other relevant information the public would like
to share as it relates to the GDUFA program, including but not limited
to the following topic areas:

     supply chain security and drug shortages;
     drug quality and advanced manufacturing; and
     complex products.

    In general, the public meeting's format will include presentations
by FDA and our stakeholders, which may include scientific and academic
experts, health care professionals, representatives of patient and
consumer advocacy groups, the generic drug industry, and the general
public. The amount of time available for public testimony will be
determined by the number of persons who register to present during the
virtual public meeting. A draft agenda and other background information
for the public meeting will be posted at https://www.fda.gov/gdufa by
July 14, 2020.

III. Participating in the Public Meeting

    Registration: FDA is seeking participation (i.e., oral remote
presentations) during the virtual public meeting by all interested
parties, including but not limited to scientific and academic experts,
health care professionals, representatives of patient and consumer
advocacy groups, the generic drug industry, and the general public.
Persons interested in attending this virtual public meeting should
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provide complete contact information for each attendee, including name,
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    Requests for Oral Presentations: If you wish to present during a
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requests for designated representatives to participate in the focused
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amount of time allotted to each presenter and the approximate time each
oral presentation is to begin, and will select and notify participants
by July 8, 2020. All requests to make oral presentations must be
received by the close of registration on July 7, 2020, 11:59 p.m.
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must be emailed to<EMAIL_ADDRESS>no later than July 14,
2020. No commercial or promotional material will be permitted to be
presented or distributed during the virtual public meeting.
    Streaming Webcast of the Public Meeting: This virtual public
meeting will be accessible via webcast only. In order to connect to the
webcast, you must have Adobe Connect. The link for the webcast will be
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    If you have never attended a Connect Pro event before, test your
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publishes in the Federal Register, but websites are subject to change
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    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/gdufa.

    Dated: June 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13749 Filed 6-25-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 7 (Friday, January 10, 2020)]
[Rules and Regulations]
[Pages 1268-1269]
[FR Doc No: 2019-28507]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2019-0757; Airspace Docket No. 19-AEA-13]
RIN 2120-AA66

Amendment of the Class E Airspace; Coudersport, PA; and
Revocation of Class E Airspace; Galeton, PA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends the Class E airspace extending upward from
700 feet above the surface at Charles Cole Memorial Hospital Heliport,
Coudersport, PA, and revokes the Class E airspace extending upward from
700 feet above the surface at Cherry Springs Airport, Galeton, PA. This
action is due to an airspace review caused by the closure of the Cherry
Spring Airport. The geographic coordinates of Charles Cole Memorial
Hospital Heliport would also be updated to coincide with the FAA's
aeronautical database. Airspace redesign is necessary for the safety
and management of instrument flight rules (IFR) operations at Charles
Cole Memorial Hospital Heliport.

DATES: Effective 0901 UTC, March 26, 2020. The Director of the Federal
Register approves this incorporation by reference action under Title 1
Code of Federal Regulations part 51, subject to the annual revision of
FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11D, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11D at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends the Class E airspace extending upward from 700 feet above
the surface at Charles Cole Memorial Hospital Heliport, Coudersport,
PA, and revokes the Class E airspace extending upward from 700 feet
above the surface at Cherry Springs

Airport, Galeton, PA, to support IFR operations at Charles Cole
Memorial Hospital Heliport.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (84 FR 53346; October 7, 2019) for Docket No. FAA-2019-0757 to
amend the Class E airspace extending upward from 700 feet above the
surface at Charles Cole Memorial Hospital Heliport, Coudersport, PA,
and revoke the Class E airspace extending upward from 700 feet above
the surface at Cherry Springs Airport, Galeton, PA. Interested parties
were invited to participate in this rulemaking effort by submitting
written comments on the proposal to the FAA. One comment was received.
The FAA reviewed the comment and found that it does not relate to this
action so no response is provided.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11D, dated August 8, 2019, and effective September 15,
2019, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11D, Airspace Designations and
Reporting Points, dated August 8, 2019, and effective September 15,
2019. FAA Order 7400.11D is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11D lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to Title 14 Code of Federal Regulations (14 CFR)
part 71:
    Amends the Class E airspace extending upward from 700 feet above
the surface to within a 6.3-mile radius (increased from an 6-mile
radius) of Charles Cole Memorial Hospital Heliport, Coudersport, PA;
removes the exclusionary language from the airspace legal description
as it is no longer required; and updates the geographic coordinates of
Charles Cole Memorial Hospital Heliport to coincide with the FAA's
aeronautical database;
    And removes the Class E airspace extending upward from 700 feet
above the surface at Cherry Springs Airport, Galeton, PA, due to the
closure of the airport.
    This action is the result of an airspace review caused by the
closure of the Cherry Springs Airport, Galeton, PA.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11D,
Airspace Designations and Reporting Points, dated August 8, 2019, and
effective September 15, 2019, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AEA PA E5 Coudersport, PA [Amended]

Charles Cole Memorial Hospital Heliport, PA
    (Lat. 41[deg]46'18'' N, long. 77[deg]58'47'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.3-mile radius of the Charles Cole Memorial Hospital
Heliport.
* * * * *

AEA PA E5 Galeton, PA [Removed]

    Issued in Fort Worth, Texas, on December 30, 2019.
Thomas L. Lattimer,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2019-28507 Filed 1-9-20; 8:45 am]
 BILLING CODE 4910-13-P


MEMORANDUM
To: 		Docket EPA-HQ-OAR-2023-0072
From: 		U.S. EPA
--------------------------------------------------------------------------------
Subject: 	State Plans for Proposed Emission Guidelines for Existing Fossil Fuel-fired EGUs References
--------------------------------------------------------------------------------

THE FOLLOWING ARE REFERENCES THE U.S. Environmental Protection Agency (EPA) cited in section XII (State Plans for Proposed Emission Guidelines for Existing Fossil Fuel-fired EGUs) of the preamble of the proposed New Source Performance Standards for Greenhouse Gas Emissions from New, Modified, and Reconstructed Fossil Fuel-Fired Electric Generating Units; Emission Guidelines for Greenhouse Gas Emissions from Existing Fossil Fuel-Fired Electric Generating Units; and Repeal of the Affordable Clean Energy Rule.


Technical person-hours per year
                                  (E = C x D)
                                      (F)
                       Management person-hours per year
                                (F = E x 0.05)
                                      (G)
                        Clerical person-hours per year
                                 (G = E x 0.1)
                                      (H)
                                   Cost, $ b
1.  Initial Notifications: [c]

 -   Notification of reconstruction-process
  vents [d]
                                       1
                                      0.4
                                      0.4
                                     153.3
                                     61.32
                                     3.07
                                     6.13
                                   3,177.75
--------------------------------------------------------------------------------
  -  Notification of compliance status -
--------------------------------------------------------------------------------
  storage vessel [e]
                                       1
                                      0.9
                                      0.9
                                     153.3
                                    137.97
                                     6.90
                                     13.80
                                   7,149.94
--------------------------------------------------------------------------------
  -  Notification of compliance status -         equipment leaks [e]
                                       1
                                      1.1
                                      1.1
                                     153.3
                                    168.63
                                     8.43
                                     16.86
                                   8,738.81
--------------------------------------------------------------------------------
  -  Notification of compliance status-
--------------------------------------------------------------------------------
  process vents [e]
                                       1
                                      0.9
                                      0.9
                                     153.3
                                    137.97
                                     6.90
                                     13.80
                                   7,149.94
--------------------------------------------------------------------------------
  -  Notification of compliance status-
--------------------------------------------------------------------------------
  heat exchange systems [e]
                                       2
                                       1
                                       2
                                     153.3
                                    306.60
                                     15.33
                                     30.66
                                   15,888.75
--------------------------------------------------------------------------------
  -  Notification of performance test-
--------------------------------------------------------------------------------
  process vent control device [e]
                                       1
                                      0.4
                                      0.4
                                     153.3
                                     61.32
                                     3.07
                                     6.13
                                   3,177.75
  -  Notification of  storage vessel
  inspection
                                       1
                                      0.9
                                      0.9
                                     153.3
                                    137.97
                                     6.90
                                     13.80
                                   7,149.94
2.  Periodic Reports: [f]

  -  Review of startup, shutdown,
  malfunction reports

                                      N/A

  -  Semiannual parameter exceedance
  reports
                                       4
                                       2
                                       8
                                     153.3
                                   1,226.40
                                     61.32
                                    122.64
                                   63,554.99
  -  Annual tank  inspection failure reports
                                       4
                                       1
                                       4
                                     153.3
                                    613.20
                                     30.66
                                     61.32
                                   31,777.50
  -  Semiannual compliance/LDAR reports
                                      10
                                       2
                                      20
                                     153.3
                                   3,066.00
                                    153.30
                                    306.60
                                  158,887.48
  -  Semiannual compliance/heat exchange systems
                                       1
                                       2
                                       2
                                     153.3
                                    306.60
                                     15.33
                                     30.66
                                   15,888.75
Subtotal

                                   6,223.98
                                    311.20
                                    622.40
                                  322,541.58
TOTAL

                                     7,158
                                   $322,542

Assumptions:
[a]  We have assumed that there are 153 existing petroleum refineries plus one new refinery which are respondents over the 3-year term of  the ICR, yielding an average of 153.3 respondents per year.  We have further assumed that a refinery has the following affected facilities: 9 storage vessels; 11 process units which are subject to leak detection and repair (LDAR) provisions; 9 process vents for which it would be required to do monitoring, recordkeeping and reporting; and 3 heat exchange systems which are subject to a monthly sampling program for VOC leak detection and repair, as well as recordkeeping and reporting requirements to ensure compliance with the program.
[b]  This cost is based on the following labor rates:  Managerial rate of $62.27 (GS-13, Step 5, $38.92 + 60%), Technical rate of $46.21 (GS-12, Step 1, $28.88 + 60%), and Clerical rate of $25.01 (GS-6, Step 3, $15.63 + 60%).  These rates are from the Office of Personnel Management (OPM) 2011 General Schedule, which excludes locality rates of pay.
[c]  We have assumed that all existing respondents over the 3-year term of the ICR have complied with the rule's initial monitoring, recordkeeping and reporting requirements for their existing units, including: initial notifications; the design analysis and establishing operating parameters for storage vessels, LDAR  initial requirements, and initial performance test for process vents routed to a control device (4 of 9 process vents); and development of record system.  However, we have assumed that 10 percent of respondents (15.3)  would have to comply with initial rule requirements for reconstructed units.
[d]   The notification of reconstruction is only required for process vents controls.  We have assumed two process vent controls per respondent, and that 10 percent of process vent will be reconstructed and tested.  Further, we assumed two notifications per test.
[e]   The notification of compliance status would include performance test results, as required by the general provisions.
[f]   The rule requires that sources semiannual compliance reports addressing each affected facility subject to the rule.  The startup, shutdown and malfunction reports are to be submitted with the next semiannual reports
N/A  Not applicable


From:
Jones, DonnaLee<EMAIL_ADDRESS>Sent:
Wednesday, August 14, 2019 10:30 AM
To:
D'Angelo, Wayne J<EMAIL_ADDRESS>Eric Stuart<EMAIL_ADDRESS>Cc:
Raymond, Gabrielle<EMAIL_ADDRESS>Subject:
EAF rule file for industry mark-up

Wayne - Nice talking to you yesterday. Attached is a Word version of AAa. You can use this to make redline changes to request. Please also add a comment "bubble" with the rationale for the change. These can be detailed as needed. Feel free to supply additional documents, if needed. To be clear, I would only like one file submitted back to me from industry with your comments.
We will assume that same changes are needed for AA. If there is anything specific to AA only, let me know and I can send you a Word file for that rule. It will be easier if we have comments just in one rule file, so I'm just sending AAa for now.
No time line for this because I will likely not be starting up on EAFs until after March 2020. But feel free to contact me in the meantime if you have any questions.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

<< NSPS-Word-Subpart-AAa-2019.docx >>


[Federal Register Volume 84, Number 58 (Tuesday, March 26, 2019)]
[Notices]
[Pages 11293-11294]
[FR Doc No: 2019-05712]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: EG19-81-000.
    Applicants: High Lonesome Mesa Wind, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of High Lonesome Mesa Wind, LLC.
    Filed Date: 3/19/19.
    Accession Number: 20190319-5174.
    Comments Due: 5 p.m. ET 4/9/19.

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

    Docket Numbers: ER16-38-005.
    Applicants: Kingbird Solar A, LLC.
    Description: Compliance filing: Kingbird Solar A Supplemental
Notice of Tariff Update to be effective 3/19/2019.
    Filed Date: 3/19/19.
    Accession Number: 20190319-5164.
    Comments Due: 5 p.m. ET 4/9/19.

    Docket Numbers: ER19-688-001.
    Applicants: Southern California Edison Company.
    Description: Tariff Amendment: SCE's Response to Deficiency re
Amended Agreement Harbor Cogeneration Company to be effective 12/21/
2018.
    Filed Date: 3/20/19.
    Accession Number: 20190320-5056.

    Comments Due: 5 p.m. ET 4/10/19.

    Docket Numbers: ER19-1047-002.
    Applicants: VESIVEC LLC.
    Description: Tariff Amendment: Second Supplement to MBRA Tariff to
be effective 3/21/2019.
    Filed Date: 3/20/19.
    Accession Number: 20190320-5109.
    Comments Due: 5 p.m. ET 4/10/19.

    Docket Numbers: ER19-1383-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Cancellation: Notice of Cancellation of WMPA/SA
No. 4505; Queue No. Z2-097 to be effective 5/2/2019.
    Filed Date: 3/19/19.
    Accession Number: 20190319-5157.
    Comments Due: 5 p.m. ET 4/9/19.

    Docket Numbers: ER19-1384-000.
    Applicants: MidAmerican Central California Transco, LLC.
    Description: Application for Authorization under Section 205 of the
Federal Power Act of MidAmerican Central California Transco, LLC.
    Filed Date: 3/19/19.
    Accession Number: 20190319-5166.
    Comments Due: 5 p.m. ET 4/9/19.

    Docket Numbers: ER19-1385-000.
    Applicants: AEP Texas Inc.
    Description: Sec.  205(d) Rate Filing: AEPTX-Woodward Mountain Wind
I Interconnection Agreement Second Amd & Restated to be effective 3/5/
2019.
    Filed Date: 3/20/19.
    Accession Number: 20190320-5036.
    Comments Due: 5 p.m. ET 4/10/19.

    Docket Numbers: ER19-1386-000.
    Applicants: Orange and Rockland Utilities, Inc.
    Description: Sec.  205(d) Rate Filing: Attachment J--Municipal
Underground Surcharge Revision to be effective 4/1/2019.
    Filed Date: 3/20/19.
    Accession Number: 20190320-5074.
    Comments Due: 5 p.m. ET 4/10/19.

    Docket Numbers: ER19-1387-000.
    Applicants: ISO New England Inc.
    Description: Sec.  205(d) Rate Filing: Ministerial Filing to
Conform Tariff Sections to be effective 4/1/2019.
    Filed Date: 3/20/19.
    Accession Number: 20190320-5106.
    Comments Due: 5 p.m. ET 4/10/19.

    Docket Numbers: ER19-1388-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2019-03-20_SA 3276 EDF
Renewables--MDU GIA (G359R) to be effective 3/6/2019.
    Filed Date: 3/20/19.
    Accession Number: 20190320-5112.
    Comments Due: 5 p.m. ET 4/10/19.

    Docket Numbers: ER19-1389-000.
    Applicants: Mid-Atlantic Interstate Transmission, LLC, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: MAIT submits 19 Engineering
and Construction Service Agreement to be effective 5/24/2019.
    Filed Date: 3/20/19.
    Accession Number: 20190320-5114.
    Comments Due: 5 p.m. ET 4/10/19

    Docket Numbers: ER19-1390-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2019-03-20_SA 3277 EDF
Renewables--OTP FCA (G359R) to be effective 3/6/2019.
    Filed Date: 3/20/19.
    Accession Number: 20190320-5127.
    Comments Due: 5 p.m. ET 4/10/19.

    Docket Numbers: ER19-1391-000.
    Applicants: Central Hudson Gas & Electric Corporation.
    Description: Sec.  205(d) Rate Filing: Revision to FERC Rate
Schedule 202 to be effective 3/11/2019.
    Filed Date: 3/20/19.
    Accession Number: 20190320-5129.
    Comments Due: 5 p.m. ET 4/10/19.

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

    Dated: March 20, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-05712 Filed 3-25-19; 8:45 am]
BILLING CODE 6717-01-P