[Federal Register Volume 88, Number 248 (Thursday, December 28, 2023)]
[Notices]
[Pages 89677-89678]
[FR Doc No: 2023-28685]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER24-720-000]

SJS 1 Storage, LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
SJS 1 Storage, LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is January 10, 2024.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all

interested persons an opportunity to view and/or print the contents of
this document via the internet through the Commission's Home Page
(http://www.ferc.gov). From the Commission's Home Page on the internet,
this information is available on eLibrary. The full text of this
document is available on eLibrary in PDF and Microsoft Word format for
viewing, printing, and/or downloading. To access this document in
eLibrary, type the docket number excluding the last three digits of
this document in the docket number field.
    User assistance is available for eLibrary and the Commission's
website during normal business hours from FERC Online Support at 202-
502-6652 (toll free at 1-866-208-3676) or email at
[email protected], or the Public Reference Room at (202) 502-
8371, TTY<PHONE_NUMBER>. Email the Public Reference Room at
[email protected].
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: December 21, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-28685 Filed 12-27-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)]
[Notices]
[Page 18414]
[FR Doc No: 2015-07809]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-1657]

Determination of Regulatory Review Period for Purposes of Patent
Extension; JUXTAPID

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for JUXTAPID and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Campus, Rm. 3180, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub, L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of the U.S. Patent and
Trademark Office (USPTO) may award (for example, half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a human drug product will include all of
the testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human drug product JUXTAPID
(lomitapide mesylate). JUXTAPID is indicated as an adjunct to a low-fat
diet and other lipid-lowering treatments, including LDL apheresis where
available, to reduce low-density lipoprotein cholesterol, total
cholesterol, apolipoprotein B, and non-high-density lipoprotein
cholesterol in patients with homozygous familial hypercholesterolemia.
Subsequent to this approval, the USPTO received a patent term
restoration application for JUXTAPID (U.S. Patent No. 5,712,279) from
Aegerion Pharmaceuticals, Inc., and the USPTO requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated January 31, 2014, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of JUXTAPID represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
JUXTAPID is 6,002 days. Of this time, 5,705 days occurred during the
testing phase of the regulatory review period, while 297 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: July 18, 1996. FDA has verified the applicant's claim that
the date the investigational new drug application became effective was
on July 18, 1996.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: February
29, 2012. FDA has verified the applicant's claim that the new drug
application (NDA) for Juxtapid (NDA 203-858) was submitted on February
29, 2012.
    3. The date the application was approved: December 21, 2012. FDA
has verified the applicant's claim that NDA 203-858 was approved on
December 21, 2012.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 5 years of patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by June 5, 2015. Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period
by October 5, 2015. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07809 Filed 4-3-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 223 (Monday, November 19, 2018)]
[Rules and Regulations]
[Pages 58186-58188]
[FR Doc No: 2018-25129]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0371]
RIN 1625-AA00

Safety Zone; Penn's Landing Fireworks, Delaware River,
Philadelphia PA

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: The Coast Guard is amending the existing recurring fireworks
safety zone on the Delaware River Adjacent to Penn's Landing in
Philadelphia, Pennsylvania. This amendment allows the Coast Guard to
enforce the safety zone at this location throughout the entire year.
The Coast Guard will notify the public of upcoming enforcement of the
zone through publication of a Notice of Enforcement in the Federal
Register and Broadcast Notice to Mariners. This change will expedite
public notification of events at the location and ensure the protection
of the maritime public and event participants from the hazards
associated with fireworks displays in the Delaware River adjacent to
Penn's Landing.

DATES: This rule is effective December 19, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2018-0371 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Edmund Ofalt, U.S. Coast Guard, Sector
Delaware Bay, Waterways Management Division; telephone<PHONE_NUMBER>,
email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

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

II. Background Information and Regulatory History

    The Coast Guard routinely receives requests for fireworks displays
in the Delaware River Adjacent to Penn's Landing in Philadelphia,
Pennsylvania. As a result, the Coast Guard previously issued a rule
creating a recurring safety zone location for this location, listed as
entry (a)16 in the table to 33 CFR 165.506. That regulation lists
possible days of anticipated enforcement as July 2nd, 3rd, 4th, or 5th;
Columbus Day; December 31st, and January 1st. In recent years, however,
the number of firework events at this location have significantly
increased. To date in the year 2018 there have been 13 requests for
fireworks events at this location--many more than the anticipated
number of approximately 3 events covered by the current regulation. The
additional requests fall outside the enforcement dates listed in the
CFR. As a result, the Coast Guard had to issue numerous temporary
safety zones to cover the additional events that fall outside of the
coverage of the current regulation. In accordance with good cause
exceptions found in 5 U.S.C. 553, the rules creating these temporary
safety zones are generally not preceded by notice of proposed
rulemaking due to the short lead-time often provided to the Coast
Guard.
    In response, on September 21, 2018, the Coast Guard published a
notice of proposed rulemaking (NPRM) titled ``Safety Zone; Penn's
Landing Fireworks, Delaware River, Philadelphia PA'' (83 FR 47852).
There we stated why we issued the NPRM, and invited comments on our
proposed regulatory action. During the comment period that ended
October 22, 2018, we received one comment.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Delaware Bay (COTP) has determined that
potential hazards associated with the fireworks to be used in this type
of display will be a safety concern for anyone within a 500 yard radius
of the fireworks barge. The purpose of this rule is to ensure safety of
vessels and the navigable waters in the safety zone before, during and
after the scheduled event.

IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received one comment on our NPRM published
September 21, 2018. The comment was supportive of the proposed
rulemaking. There are no changes in the regulatory text of this rule
from the proposed rule in the NPRM.
    This rule revises the recurring fireworks safety zone near Penn's
Landing, listed as entry (a)16 in the table to 33 CFR 165.506. Although
this safety zone will be January through December each year,
enforcement of the safety zone will only be for short periods of time
before, during and after fireworks shows at this location. In order to
promote clarity, Penn's Landing has been added to the location column
of the revised regulatory text. The column defining the boundaries of
the regulated area has also been updated to improve clarity and more
efficiently define the regulated area. The revised safety zone will
cover all navigable waters of the Delaware River within 500 yards of a
fireworks barge located at approximately 39[deg]56'49'' N, longitude
075[deg]08'11'' W, adjacent to Penn's Landing, Philadelphia,
Pennsylvania.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration and time of day of the safety zone. Only a small,
designated area of the Delaware River will be impacted during
enforcement. Consistent with the current regulatory text found in 33
CFR 165.506(d), the default time period this zone will be enforced
during each activation is between 5:30 p.m. and 1 a.m. That regulation,
however, allows for modifications in this timeframe. In practice, the
zone is typically activated with only a two-hour enforcement time
period. During the evening, when enforcement is occurring, commercial
and recreational traffic is normally low. Notification of enforcement
dates and times will be made, at a minimum, to the maritime community
via Notice of Enforcement published in the Federal Register, Broadcast
Notice to Mariners, and actual notice will be provided via on-scene
enforcement vessels. Notifications will be updated as necessary to keep
the maritime community informed of the status of the safety zone.

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 received no comments from the Small Business
Administration on this rulemaking. The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have a significant economic
impact on a substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we want to assist small
entities in understanding this rule.
    If the rule would affect your small business, organization, or
governmental jurisdiction and you have questions concerning its
provisions or options for compliance, please contact the person listed
in the FOR FURTHER INFORMATION CONTACT section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive
Order13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact 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 rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Commandant Instruction M16475.1D, which guide the
Coast Guard in complying with the National Environmental Policy Act of
1969 (42 U.S.C. 4321-4370f), and have determined that this action is
one of a

category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone that will only be enforced for a short duration and
excludes vessels from entry into or remaining within a specified area
on the Delaware River. It is categorically excluded from further review
under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual
023-01-001-01, Rev. 01. A Record of Environmental Consideration
supporting this determination is available in the docket where
indicated under ADDRESSES.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. In Sec.  165.506, revise entry (a)16 in the table to Sec.  165.506
to read as follows:

 Sec.  165.506  Safety Zones; Fireworks Displays in the Fifth Coast
Guard District.

* * * * *

                         Table to Sec.   165.506
------------------------------------------------------------------------

------------------------------------------------------------------------
             (a) Coast Guard Sector Delaware Bay--COTP Zone
------------------------------------------------------------------------

                              * * * * * * *
16 January 1st-December 31st:   Penn's Landing,    All waters of
 Any day specified by Notice     Delaware River,    Delaware River,
 of Enforcement published in     Philadelphia PA;   adjacent to Penn's
 the Federal Register and        Safety Zone.       Landing,
 broadcast via Broadcast                            Philadelphia, PA,
 Notice to Mariners.                                within 500 yards of
                                                    a fireworks barge at
                                                    approximate position
                                                    latitude
                                                    39[deg]56'49'' N,
                                                    longitude
                                                    075[deg]08'11'' W.

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

    Dated: November 13, 2018,
Scott E. Anderson,
Captain, U.S. Coast Guard, Captain of the Port Delaware Bay.
[FR Doc. 2018-25129 Filed 11-16-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: August 17, 2010 (Volume 75, Number 158)]
[Notices]
[Page 50766-50767]
[DOCID:fr17au10-56]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0418]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Institutional Review Boards

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the recordkeeping requirements
for institutional review boards (IRBs).

DATES:  Submit either electronic or written comments on the collection
of information by October 18, 2010.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane., rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
Pl50-400B, Rockville, MD 20850,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520) Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c)

and includes agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Institutional Review Boards--21 CFR 56.115 (OMB Control Number 0910-
0130)--Extension

    When reviewing clinical research studies regulated by FDA, IRBs are
required to create and maintain records describing their operations,
and make the records available for FDA inspection when requested. These
records include: Written procedures describing the structure and
membership of the IRB and the methods that the IRB will use in
performing its functions; the research protocols, informed consent
documents, progress reports, and reports of injuries to subjects
submitted by investigators to the IRB; minutes of meetings showing
attendance, votes, and decisions made by the IRB, the number of votes
on each decision for, against, and abstaining, and the basis for
requiring changes in research or for disapproving research; records of
continuing review activities; copies of all correspondence between
investigators and the IRB; statement of significant new findings
provided to subjects of the research; and a list of IRB members by
name, showing each member's earned degrees, representative capacity,
and experience in sufficient detail to describe each member's
contributions to the IRB's deliberations, and any employment
relationship between each member and the IRB's institution. This
information is used by FDA in conducting audit inspections of IRBs to
determine whether IRBs and clinical investigators are providing
adequate protections to human subjects participating in clinical
research.
    FDA estimates the burden of this collection of information as
follows:

                                                   Table 1.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of       Annual Frequency  of     Total Annual        Hours per
                      CFR Section                         Recordkeepers        Recordkeeping          Records          Recordkeeper       Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
56.115                                                              2,500                  14.6             36,500                100          3,650,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                3,650,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The recordkeeping requirement burden is based on the following: The
burden for each of the paragraphs under 21 CFR 56.115 has been
considered as one estimated burden. FDA estimates that there are
approximately 2,500 IRBs. The IRBs meet on an average of 14.6 times
annually. The agency estimates that approximately 100 hours of person-
time per meeting are required to meet the requirements of the
regulation.

    Dated: August 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-20273 Filed 8-16-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 77, Number 224 (Tuesday, November 20, 2012)]
[Notices]
[Pages 69643-69644]
[FR Doc No: 2012-28119]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3349-EM; Docket ID FEMA-2011-0001]

Maryland; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of Maryland (FEMA-3349-EM), dated October 28,
2012, and related determinations.

DATES: Effective Date: October 28, 2012.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated October 28, 2012, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in the State of
Maryland resulting from Hurricane Sandy beginning on October 26,
2012, and continuing, are of sufficient severity and magnitude to
warrant an emergency declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq.
(``the Stafford Act''). Therefore, I declare that such an emergency
exists in the State of Maryland.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), limited to direct Federal assistance, under the Public
Assistance program.
    Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order

to provide Federal assistance, you are hereby authorized to allocate
from funds available for these purposes such amounts as you find
necessary for Federal emergency assistance and administrative
expenses.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, Michael
J. Lapinski, of FEMA is appointed to act as the Federal Coordinating
Officer for this declared emergency.
    The following areas of the State of Maryland have been designated
as adversely affected by this declared emergency:

    Emergency protective measures (Category B), limited to direct
federal assistance, under the Public Assistance program for all
counties and the Independent City of Baltimore in the State of
Maryland.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2012-28119 Filed 11-19-12; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 81, Number 247 (Friday, December 23, 2016)]
[Rules and Regulations]
[Pages 94262-94267]
[FR Doc No: 2016-31032]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1989-0009; FRL-9957-31-Region 3]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List: Partial Deletion of the North Penn Area 6
Superfund Site

AGENCY: Environmental Protection Agency.

ACTION: Direct final rule; notice of partial deletion of the North Penn
Area 6 Superfund Site from the National Priorities List.

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

SUMMARY: The Environmental Protection Agency (EPA) Region III is
publishing a direct final notice of partial deletion of a portion of
the North Penn Area 6 Superfund Site (Site) located in Lansdale
Borough, Montgomery County, Pennsylvania, from the National Priorities
List (NPL). The deletion affects approximately 6.5 acres located at 135
East Hancock Street (the ``Administrative Parcel''). The NPL,
promulgated pursuant to section 105 of the Comprehensive Environmental
Response, Compensation, and Liability Act (CERCLA) of 1980, as amended,
is found at Appendix B of the National Oil and Hazardous Substances
Pollution Contingency Plan (NCP). This direct final partial deletion is
being published by EPA with the concurrence of the Commonwealth of
Pennsylvania, through the Pennsylvania Department of Environmental
Protection (PADEP), because EPA has determined that all appropriate
response actions at the Administrative Parcel under CERCLA, other than
five-year reviews, have been completed. However, this partial deletion
does not preclude future actions at the Administrative Parcel under
Superfund.
    This partial deletion pertains to soils and groundwater of the
Administrative Parcel portion of the Site. The other portions of the
Site will remain on the NPL, and are not being considered for deletion
as part of this action.

DATES: This direct final partial deletion is effective February 21,
2017 unless EPA receives adverse comments by January 23, 2017. If
adverse comments are received, EPA will publish a timely withdrawal of
the direct final partial deletion in the Federal Register informing the
public that the partial deletion will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID no. EPA-HQ-
SFUND-1989-0009, by one of the following methods:
     http://www.regulations.gov. Follow on-line instructions
for submitting comments.
     Email<EMAIL_ADDRESS>     Mail: U.S. Environmental Protection Agency, Region III,
Attn: Huu Ngo (3HS21), 1650 Arch Street, Philadelphia, PA 19103-2029
     Hand Delivery: U.S. Environmental Protection Agency,
Region III, Attn: Huu Ngo (3HS21), 1650 Arch Street, Philadelphia, PA
19103-2029, Phone:<PHONE_NUMBER>, Business Hours: Mon. through Fri.--
8:00 a.m. to 4:30 p.m. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID no. EPA-HQ-SFUND-
1989-0009. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to EPA without
going through http://www.regulations.gov, your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at:
     U.S. EPA Region III, Superfund Records Center, 6th Floor,
1650 Arch Street, Philadelphia, PA 19103-2029;

(215) 814-3157, Monday through Friday 8:00 a.m. to 5:00 p.m.
     The Lansdale Public Library, 301 Vine St, Lansdale, PA
19446; phone<PHONE_NUMBER>. Monday through Friday 10:00 a.m.-9:00 p.m.

FOR FURTHER INFORMATION CONTACT: Huu Ngo, Remedial Project Manager
(3HS21), U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, PA 19103-2029;<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
II. NPL Deletion Criteria
III. Partial Deletion Procedures
IV. Basis for Partial Site Deletion
V. Partial Deletion Action

I. Introduction

    EPA Region III is publishing this direct final Notice of Partial
Deletion of a portion the North Penn Area 6 Superfund Site from the
National Priorities List (NPL). This partial deletion pertains to the
soils and groundwater of the Administrative Parcel portion of the Site.
The NPL constitutes Appendix B of 40 CFR part 300, which is the
National Oil and Hazardous Substances Pollution Contingency Plan (NCP),
which EPA promulgated pursuant to section 105 of the Comprehensive
Environmental Response, Compensation and Liability Act (CERCLA) of
1980, as amended. EPA maintains the NPL as the list of sites that
appear to present a significant risk to public health, welfare, or the
environment. Sites on the NPL may be the subject of remedial actions
financed by the Hazardous Substance Superfund (Fund). This partial
deletion of the North Penn Area 6 Site is proposed in accordance with
40 CFR 300.425(e) and is consistent with the Notice of Policy Change:
Partial Deletion of Sites Listed on the National Priorities List. 60 FR
55466 (Nov. 1, 1995). As described in 40 CFR 300.425(e)(3) of the NCP,
a portion of a site deleted from the NPL remains eligible for Fund-
financed remedial actions if future conditions warrant such actions.
    Section II of this document explains the criteria for deleting
sites from the NPL. Section III discusses the procedures that EPA is
using for this action. Section IV discusses the Administrative Parcel
of the North Penn Area 6 Superfund Site and demonstrates how it meets
the deletion criteria. Section V discusses EPA's action to delete the
Administrative Parcel portion of the Site from the NPL unless adverse
comments are received during the public comment period.

II. NPL Deletion Criteria

    The NCP establishes the criteria that EPA uses to delete sites from
the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted
from the NPL where no further response is appropriate. In making such a
determination pursuant to 40 CFR 300.425(e), EPA will consider, in
consultation with the Commonwealth, whether any of the following
criteria have been met:
    i. Responsible parties or other persons have implemented all
appropriate response actions required;
    ii. all appropriate Fund-financed response under CERCLA has been
implemented, and no further response action by responsible parties is
appropriate; or
    iii. the remedial investigation has shown that the release poses no
significant threat to public health or the environment and, therefore,
the taking of remedial measures is not appropriate.
    Pursuant to CERCLA section 121(c) and the NCP, EPA conducts five-
year reviews to ensure the continued protectiveness of remedial actions
where hazardous substances, pollutants, or contaminants remain at a
site above levels that allow for unlimited use and unrestricted
exposure. EPA conducts such five-year reviews even if a site is deleted
from the NPL. EPA may initiate further action to ensure continued
protectiveness at a deleted site if new information becomes available
that indicates such action is appropriate. Whenever there is a
significant release from a site deleted from the NPL, the deleted site
may be restored to the NPL without application of the hazard ranking
system.

III. Partial Deletion Procedures

    The following procedures apply to deletion of the Administrative
Parcel portion of the Site:
    (1) EPA consulted with the Commonwealth of Pennsylvania prior to
developing this direct final Notice of Partial Deletion and the Notice
of Intent for Partial Deletion co-published today in the ``Proposed
Rules'' section of the Federal Register.
    (2) EPA provided the Commonwealth 30 working days for review of
this notice and the parallel Notice of Intent for Partial Deletion
prior to their publication today, and the Commonwealth, through PADEP,
concurred on the partial deletion of the Site from the NPL.
    (3) Concurrently with the publication of this direct final Notice
of Partial Deletion, a notice of the availability of the parallel
Notice of Intent for Partial Deletion is being published in a major
local newspaper, The Reporter. The newspaper notice announces the 30-
day public comment period concerning the Notice of Intent for Partial
Deletion of the Site from the NPL.
    (4) The EPA placed copies of documents supporting the partial
deletion in the deletion docket and made these items available for
public inspection and copying at the Site information repositories
identified above.
    (5) If adverse comments are received within the 30-day public
comment period on this partial deletion action, EPA will publish a
timely notice of withdrawal of this direct final Notice of Partial
Deletion before its effective date, and will prepare a response to
comments and continue with the deletion process, as appropriate, on the
basis of the Notice of Intent for Partial Deletion and the comments
already received.
    Deletion of a portion of a site from the NPL does not itself
create, alter, or revoke any individual's rights or obligations.
Deletion of a portion of a site from the NPL does not in any way alter
EPA's right to take enforcement actions, as appropriate. The NPL is
designed primarily for informational purposes and to assist EPA
management. Section 300.425(e)(3) of the NCP states that the deletion
of a site from the NPL does not preclude eligibility for future
response actions, should future conditions warrant such actions.

IV. Basis for Partial Site Deletion

    The following information provides EPA's rationale for deleting the
Administrative Parcel portion of the Site from the NPL:

Site Background and History

    The North Penn Area 6 Superfund Site (EPA Identification Number
PAD980926976) is located primarily in Lansdale Borough, Montgomery
County, Pennsylvania. The Site is comprised of multiple properties
contaminated primarily with volatile organic compounds (VOCs) in the
soil and associated groundwater contamination. One of the properties
consists of approximately 10 acres of land located at 135 East Hancock
Street in Lansdale Borough (the ``Property''). The Property was
formerly occupied by the Tate Andale Company, and later by the Rogers
Mechanical Company. The Administrative Parcel is comprised of
approximately 6.5 acres located within the Property.
    The current owner of the Property, including the Administrative
Parcel, is

Andale Properties, LLC. Andale Properties, LLC plans to redevelop the
Property for future residential purposes. Andale Properties, LLC has
divided the Property into four Phases (1 through 4) for redevelopment.
The Administrative Parcel is comprised of Phases 2 and 3.
    The Property is currently occupied by three buildings, portions of
two former structures, and footers and concrete pads from previous on-
site buildings. A treatment system operated currently by EPA for
treatment of groundwater and multiple monitoring wells are also present
at the Property. The Property is bordered to the southwest by East
Hancock Street, and to the west, northwest, and east by railroad lines.
The ground surface elevation of the Property is approximately 370 feet
above mean sea level. The Property consists of relatively flat terrain
with a gradual slope towards the southwest. There are no surface water
bodies located within the boundaries of the Property. The nearest body
of water is the Towamencin Creek, which is located approximately 2,800
feet southwest of the Property. Surface water runoff following
precipitation events either infiltrates the ground surface or drains
towards the western portion of the Property prior to entering a swale
adjacent to the neighboring railroad tracks. Surrounding land use
includes commercial, industrial, and residential uses.
    The Tate Andale Company formerly occupied the Property dating back
to at least the 1920s, and historically used the Property to fabricate
oil coolers, heaters, and strainers. Rogers Mechanical Company
purchased the Property in 1985 and operated a plumbing and heating
business. The former Tate Andale Company was one of twenty-six property
owners/operators to be identified as a potentially responsible party
(PRP) at the Site following the detection of groundwater contamination
in the Lansdale area in 1979. North Penn Area 6 was proposed to the
National Priorities List on January 22, 1987 (52 FR 27620), and became
a Superfund Site when the listing became final on March 31, 1989 (54 FR
13296). EPA divided the Site into three operable units (OUs). Operable
Unit One (OU1) consists of Fund-financed response actions to address
the contaminated soils at certain of the properties that comprise the
Site. Operable Unit Two (OU2) consists of PRP-financed response actions
to address the contaminated soils at certain other properties that
comprise the Site. Operable Unit Three (OU3) consists of Fund-financed
and PRP-financed response actions to address the contaminated
groundwater over the entire Site. All activities associated with
investigation and remediation at the Property were performed by EPA and
financed by the Fund, and are part of OU1 and OU3. The Administrative
Parcel consists of soils and groundwater on the aforementioned
approximately 6.5 acre portion of the Property.

Remedial Investigation and Feasibility Study (OU1)

    Soils at the Property were investigated as part of the OU1 Remedial
Investigation and Feasibility Study (RI/FS). The OU1 RI at the Property
focused primarily on a coal ash and scrap metal pile located on the
southwestern portion of the Property and another area on the eastern
portion of the Property. Soil gas and soil samples were collected from
these areas, and elevated levels of VOCs were found in the area on the
eastern portion of the Property. Trichloroethylene (TCE) was detected
at concentrations up to 4600 [mu]g/kg, and contaminants associated with
the breakdown of TCE were also found at elevated levels. The Risk
Assessment determined that the contaminant levels would present a risk
to groundwater, and a cleanup standard of 131 [mu]g/kg for TCE in soil
was determined to protect groundwater. An area comprising roughly
18,000 cubic feet of soil on the east side of the Property was
determined to require treatment. The OU1 Feasibility Study considered
alternatives for remediation of the VOC-contaminated soil including No
Action, Containment with Cap, Vapor Extraction, Low Temperature Thermal
Desorption, Soil Washing/Biotreatment, Excavation and Off-site
Disposal, and In-Place Processing with Hot Air Injection.

Selected Remedy (OU1)

    The Property was one of four properties addressed in the 1995
Record of Decision (ROD) for OU1. The OU1 Remedial Action Objective was
to prevent further contamination of groundwater from contaminated
soils. The selected alternative was in-place processing using hot air
injection, with excavation and off-site disposal as a back-up. During
the Remedial Design, it was determined that hot air injection would not
achieve the performance standards of the OU1 ROD, and the backup remedy
of excavation and off-site disposal was used to meet performance
standards. Approximately 861 cubic yards of contaminated soil were
removed from the Property as part of the OU1 remedial action and
disposed of in a Resource Conservation and Recovery Act (RCRA)
permitted landfill facility in Model City, New York. EPA approved the
OU1 remedial action report for the Property in 2001.

Operable Unit 2 (OU2)

    OU2 consists of soils investigations at certain enforcement-lead
properties. The Property (including the Administrative Parcel to be
deleted from the NPL) is not included in OU2.

Remedial Investigation and Feasibility Study (OU3)

    Groundwater contamination was investigated as part of the RI/FS for
OU3. Groundwater contamination at the Property is focused primarily in
the southwestern portion of the Property. The OU3 RI/FS found
contamination from VOCs at unacceptable levels in monitoring wells and
a former production well (TA-1) on the Property. Contamination in well
TA-1 was found at concentrations up to 7,740 [mu]g/L of TCE, and the
Property was included in the OU3 Feasibility Study to evaluate
alternatives for treatment of the groundwater. The OU3 Feasibility
Study considered several alternatives involving extraction of
contaminated groundwater using differing treatment technologies and
differing discharge points.

Selected Remedy (OU3)

    The Property was included in the OU3 ROD in 2000, which called for
construction of groundwater extraction and treatment systems at several
properties, including the Property, included in the Site to remediate
the contaminated groundwater. The goal of the groundwater extraction
and treatment systems is to restore the aquifer to beneficial use as a
potable use aquifer. The major components of the selected remedy in the
OU3 ROD include the following:
     Completion of a groundwater remedial design study to
determine the most efficient design of a groundwater extraction and
treatment system.
     Installation, operation, and maintenance of on-site
groundwater extraction wells to remove contaminated groundwater from
beneath the Site and to prevent contaminants from migrating off-site.
     Installation, operation, and maintenance of air stripping
treatment at on-site groundwater extraction wells to treat groundwater
to required cleanup levels.
     Construction, operation, and maintenance of a pipeline
from the on-site groundwater treatment systems to the nearest surface
water body or storm drain leading to a surface water body.

     Periodic sampling of groundwater and treated water to
ensure treatment components are effective and groundwater remediation
is progressing towards the cleanup levels.
    During the Remedial Design of the groundwater extraction and
treatment system at the Property, EPA conducted a pump test on the
extraction well at the Property. The well failed to produce an adequate
yield of contaminated water to treat to significantly improve
groundwater quality. As a result, EPA conducted additional testing to
determine if adding a vapor extraction unit to the treatment system at
the Property would increase contaminant removal and improve the
performance of the OU3 selected remedy at the Property. Based on those
results, EPA issued an Explanation of Significant Differences (ESD) on
September 16, 2009, requiring implementation of a modified remedy at
the Property which includes vapor extraction to enhance the performance
of the remedy selected in the OU3 ROD. Testing also indicated that
significant cost savings could be achieved by replacing the air
stripper at the Property with a vessel containing granular activated
carbon (GAC). Therefore, the ESD further allowed EPA to modify the OU3
remedy at the Property to allow for this form of treatment. The
treatment system at the Property was built, and determined to be
operational and functional in 2012. EPA plans on transferring the
groundwater treatment system at the Property to PADEP for Operation and
Maintenance (O&M) in 2022.

Response Actions

    During the Remedial Design of the OU1 remedy to address
contaminated soils at the Property, it was determined that the
alternative selected in the OU1 ROD would not achieve the performance
standards of the ROD; therefore, the backup remedy of excavation and
off-site disposal was used to meet the performance standards.
Approximately 861 cubic yards of contaminated soil were removed from
the Property as part of the OU1 remedial action. EPA approved the OU1
remedial action report for the Property in 2001. No further actions to
remediate the soil at the Property have been required.
    During the Remedial Design of the OU3 remedy to address
contaminated groundwater at the Property, it was determined that the
alternative selected in the OU3 ROD would not treat enough contaminated
water at the Property to significantly improve groundwater quality. As
a result, EPA issued the ESD to require a modified remedy at the
Property which includes vapor extraction and allows for the replacement
of the air stripper with a vessel containing GAC to enhance the
performance of the remedy selected in the OU3 ROD. EPA built the
treatment system at the Property, and determined that it was
operational and functional in 2012. EPA continues to operate and
maintain the groundwater treatment system at the Property.

Cleanup Levels

    In the OU1 ROD, EPA selected a soil cleanup level of 131 [mu]g/kg
of trichloroethylene (TCE) to be protective of groundwater. To expedite
backfilling of excavated areas at the Property, EPA conducted Quality
Control sampling prior to excavation to delineate the extent of
contamination, and eliminate the need to keep excavation areas open
while additional sampling and analysis were being performed to
determine if the performance standard (cleanup level) for soil in the
OU1 ROD had been met. Thirty samples were collected at the Property and
sent for analysis. The performance standard was exceeded at one
location; therefore, additional samples were collected further out. As
a result of the sampling, the boundary of excavation was extended out
five feet to comply with the OU1 performance standard. After the
excavation and off-site disposal of soils was completed, EPA certified
the OU1 Remedial Action at the Property to be complete.
    The OU3 remedy to address contaminated groundwater called for
restoration of the aquifer to beneficial use as a potable use aquifer.
The OU3 ROD set the groundwater cleanup level as the EPA Maximum
Contaminant Level (MCL). The MCL for TCE is 5 ug/L. There are currently
ten monitoring wells on or near the Property: ROG-1S, ROG-1D, ROG-2S,
ROG-2I, ROG-3S, ROG-3I, ROG-4S, ROG-4I, ROG-5, and ROG-6, in addition
to the extraction well TA-1. Currently, only two of the monitoring
wells at the Property, ROG-3S and ROG-4S, show contamination above the
MCL. Most monitoring wells at the Property have shown downward trends
in contamination since the OU3 remedy was implemented. The monitoring
wells located in the Administrative Parcel (ROG-1S, ROG1D, ROG-2S, and
ROG-2I) have never exhibited contaminant concentrations in excess of
the performance standard (cleanup level) for groundwater in the OU3 ROD
and are considered to be upgradient from the current contaminated
groundwater plume.

Operation and Maintenance (O&M)

    There are no O&M requirements and no institutional controls for OU1
at the Property. For OU3, EPA plans on transferring the groundwater
treatment system at the Property to PADEP for O&M in 2022. There are no
institutional controls for OU3 at the Property. The monitoring wells on
the Administrative Parcel will continue to be sampled.

Five-Year Review

    The selected remedial actions, upon completion, will not leave
hazardous substances, pollutants, or contaminants on site above levels
that allow for unlimited use and unrestricted exposure; however, the
OU3 remedial action will require more than five years to complete. As a
result, EPA will perform Five Year Reviews at the Site pursuant to
Section 121(c) of CERCLA, 42 U.S.C. 9621(c), until the cleanup levels
for groundwater in the OU3 ROD are achieved, allowing for unlimited use
and unrestricted exposure. Five Year Reviews will be triggered by the
date that construction is completed at the entire Site.

Additional Investigations

    The owner of the Property performed additional investigations at
the Property subsequent to EPA's investigations. In 2005, fifty soil
borings were advanced throughout the Property. A soil sample was
collected from each soil boring and analyzed for VOC contamination. No
soil samples exceeded EPA's performance standards (cleanup levels) for
soil in the OU1 ROD. Nine composite samples were also collected and
analyzed for semi-volatile organic compounds (SVOCs), polychlorinated
biphenyls (PCBs), pesticides, metals, and cyanide. SVOCs, PCBs,
pesticides, and cyanide were not detected at elevated levels in these
samples; however, arsenic was detected in three samples at levels that
exceeded background and EPA Regional Screening Levels (RSLs). In 2006,
the owner of the Property conducted additional sampling in the vicinity
of the samples where the elevated levels of arsenic were found.
Eighteen additional soil borings were advanced, and two soil samples
were collected from each boring. Elevated levels of arsenic were
detected in two soil borings. EPA conducted a more rigorous evaluation
of the risks associated with the arsenic levels and determined that the
risks associated with the concentrations are within EPA's acceptable
risk range.
    The owner of the Property also conducted sampling to evaluate the
planned construction of a stormwater

basin on the Lansdale Borough electrical substation property located
within the boundaries of the Property. Twelve test pits were excavated,
two of which are located within the Administrative Parcel. The test
pits were analyzed for VOCs, and a composite sample was analyzed for
SVOCs, pesticides, PCBs, metals, and cyanide. No VOCs were detected at
levels above EPA's performance standards (cleanup levels) for soil in
the OU1 ROD. SVOCs, PCBs, metals, and cyanide were not detected at
elevated levels.
    The owner of the Property conducted additional sampling in 2016 on
an approximately 3,000 cubic yard pile of top soil to be used as ground
cover for the residential development. Twelve samples were collected
from the pile and analyzed for metals. One sample was analyzed for
hexavalent chromium. Metals concentrations were all found to be within
EPA's acceptable risk range.

Community Involvement

    Public participation activities have been satisfied as required in
CERCLA section 113(k), 42 U.S.C. 9613(k), and CERCLA section 117, 42
U.S.C. 9617. Documents in the deletion docket on which EPA relied for
recommendation of the deletion of the Administrative Parcel from the
NPL are available to the public in the information repositories. The
locations of the information repositories are set forth at the end of
the Addresses section at the beginning of this notice.

Determination That the Criteria for Deletion Have Been Met

    EPA has determined based on the investigations conducted that all
appropriate response actions under CERCLA have been implemented at the
Administrative Parcel. The remedial action for OU1 removed contaminated
soil from the Administrative Parcel. The implemented OU1 remedy for
soils has achieved performance standards specified in the OU1 ROD at
the Administrative Parcel. The four monitoring wells (ROG1S, ROG1D,
ROG2S, and ROG2I) that are located within the Administrative Parcel
have not shown significant detections of contaminants. These wells are
also considered upgradient from the current contaminated groundwater
plume. The implemented OU3 remedy for groundwater has achieved
performance standards specified in the OU3 ROD at the Administrative
Parcel and will continue to extract and treat contaminated groundwater
at other portions of the Property. The selected remedial action
objectives and associated cleanup levels for OU1 and OU3 at the
Administrative Parcel are consistent with agency policy and guidance
and have been achieved at the Administrative Parcel. No further
Superfund response action for the Administrative Parcel is needed to
protect human health and the environment. Other procedures for deletion
required by 40 CFR 300.425(e) are detailed in Section III of this
direct Final Notice of Partial Deletion of a portion of the Site.

V. Partial Deletion Action

    The EPA, with concurrence of the Commonwealth of Pennsylvania,
through the PADEP, has determined that all appropriate response actions
under CERCLA, other than five-year reviews and monitoring, have been
completed for the Administrative Parcel. Therefore, EPA is deleting the
Administrative Parcel portion of the North Penn Area 6 Superfund Site
from the NPL.
    Because EPA considers this action noncontroversial and routine, EPA
is taking it without prior publication. This action will be effective
February 21, 2017 unless EPA receives adverse comments by January 23,
2017. If adverse comments are received within the 30-day public comment
period, EPA will publish a timely withdrawal of this direct final
notice of partial deletion before the effective date of the partial
deletion, and it will not take effect. EPA will prepare a response to
comments and continue with the deletion process, as appropriate, on the
basis of the notice of intent to partially delete and the comments
already received. There will be no additional opportunity to comment.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous waste, Hazardous substances, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.

    Dated: December 5, 2016.
Cecil Rodrigues,
Acting Regional Administrator, Region III.

    For the reasons set out in this document, 40 CFR part 300 is
amended as follows:

PART 300--NATIONAL OIL AND HAZARDOUS SUBSTANCES POLLUTION
CONTINGENCY PLAN

0
1. The authority citation for part 300 continues to read as follows:

    Authority:  33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O.
12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR
2923, 3 CFR 1987 Comp., p. 193.

0
2. Table 1 of appendix B to part 300 is amended by revising the PA
entry for ``North Penn-Area 6'', ``Lansdale'' to read as follows:

Appendix B to Part 300--[Amended]

                                       Table 1--General Superfund Section
----------------------------------------------------------------------------------------------------------------
                 State                            Site name                   City/County           Notes (a)
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
PA....................................  North Penn-Area 6............  Lansdale................               P

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
(a) = Based on issuance of health advisory by Agency for Toxic Substances and Disease Registry (if scored, HRS
  score need not be greater than or equal to 28.50).
S = State top priority (included among the 100 top priority sites regardless of score).
P = Sites with partial deletion(s).

[FR Doc. 2016-31032 Filed 12-22-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 190 (Monday, October 1, 2018)]
[Notices]
[Pages 49452-49453]
[FR Doc No: 2018-21263]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2010-0001]

Petition for Waiver of Compliance

    Under part 211 of Title 49 Code of Federal Regulations (CFR), this
provides the public notice that on August 1, 2018, Santa Cruz Big Trees
& Pacific Railway Company (SCBG) petitioned the Federal Railroad
Administration (FRA) for a waiver of compliance from certain provisions
of the Federal railroad safety regulations contained at 49 CFR parts
215 and 224. FRA assigned the petition Docket Number FRA-2010-0001.
    Specifically, SCBG requests an extension of relief from 49 CFR
215.303, Stenciling of restricted cars, and 49 CFR part 224,
Reflectorization of Rail Freight Rolling Stock, for 10 SCBG freight
cars numbered: SCBG 401-402, 501-504 and 701-704, which are railroad
flat cars converted to passenger carriage cars for tourist and
excursion railroad service by the addition of seating, side structures,
and steps. Each of these freight cars is more than 50 years old,
measured from the date of original construction, and are the subject of
a parallel petition for special approval for continued operation under
Sec.  [thinsp]215.203(c). SCBG states that the required stenciling and
reflectorization would detract from both the aesthetic and historical
nature of the vintage rail car equipment. As SCBG passenger cars are
not interchanged, SCBG suggests that the stenciling recordkeeping
requirements may be preserved by maintaining a permanent file of the
restrictive conditions at the local SCBG office.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE, W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.

    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by November 15, 2018 will be considered by
FRA before final action is taken. Comments received after that date
will be considered as far as practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. DOT posts these comments, without edit, including
any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the
privacy notice of regulations.gov.

    Issued in Washington, DC.
John K. Alexy,
Deputy Associate Administrator for Railroad Safety.
[FR Doc. 2018-21263 Filed 9-28-18; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register Volume 88, Number 78 (Monday, April 24, 2023)]
[Notices]
[Page 24786]
[FR Doc No: 2023-08611]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas & Oil Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: PR23-45-000.
    Applicants: Moss Bluff Hub, LLC.
    Description: Sec.  284.123 Rate Filing: Moss Bluff Address Change
Filing to be effective 4/18/2023.
    Filed Date: 4/18/23.
    Accession Number: 20230418-5053.
    Comment Date: 5 p.m. ET 5/9/23.

    Docket Numbers: RP23-688-000.
    Applicants: Centra Pipelines Minnesota Inc.
    Description: Sec.  4(d) Rate Filing: Updated Index of Shippers
April 2023 to be effective 6/1/2023.
    Filed Date: 4/18/23.
    Accession Number: 20230418-5079.
    Comment Date: 5 p.m. ET 5/1/23.

    Docket Numbers: RP23-689-000.
    Applicants: Exxon Mobil Corporation, Par Montana Holdings, LLC.
    Description: Joint Petition for Limited Waiver of Capacity Release
Regulations, et al. of Exxon Mobil Corporation, et al.
    Filed Date: 4/17/23.
    Accession Number: 20230417-5271.
    Comment Date: 5 p.m. ET 5/1/23.

    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.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    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: April 18, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-08611 Filed 4-21-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: April 16, 2007 (Volume 72, Number 72)]
[Notices]
[Page 18990-18991]
[DOCID:fr16ap07-79]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2006-0719; FRL-8299-2]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for Phosphoric Acid
Manufacturing and Phosphate Fertilizers Production, (Renewal); EPA ICR
Number 1790.04, OMB Control Number 2060-0361

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. This ICR is scheduled to expire on May 31, 2007.
Under OMB regulations, the Agency may continue to conduct, or sponsor
the collection of information while this submission is pending at OMB.
This ICR describes the nature of the information collection and its
estimated burden and cost.

DATES: Additional comments may be submitted on or before May 16, 2007.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2006-0719, to (1) EPA online, using http://www.regulations.gov (our preferred method), by e-mail to<EMAIL_ADDRESS>or by mail to: EPA

Docket Center (EPA/DC), Environmental Protection Agency, Enforcement
and Compliance Docket and Information Center, Mail Code 2201T, 1200
Pennsylvania Avenue, NW., Washington, DC 20460, and (2) OMB at: Office
of Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attention: Desk Officer for EPA, 725 17th Street, NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Compliance Assessment
and Media Programs Division, Office of Compliance, Mail Code 2223A,
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On October 5, 2006 (71 FR 38853), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments.
    EPA has established a public docket for this ICR under Docket ID
Number EPA-HQ-OECA-2006-0719, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Enforcement and

Compliance Docket and Information Center in the EPA Docket Center (EPA/
DC), EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington,
DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for the Enforcement and Compliance Docket Center is
(202) 566-1927.
    Use EPA's electronic docket and comment system at http://www.epa.gov
,

to submit or view public comments, access the index listing of the
contents of the docket, and to access those documents in the docket
that are available electronically. Once in the system, select: ``Docket
Search,'' then key in the docket ID number identified above. Please
note that EPA's policy is that public comments, whether submitted
electronically, or in paper, will be made available for public viewing
at http://www.regulations.gov, as EPA receives them and without change, unless

the comment contains copyrighted material, CBI, or other information
whose public disclosure is restricted by statute. For further
information about the electronic docket, go to http://www.regulations.gov.

    Title: NESHAP for Phosphoric Acid Manufacturing and Phosphate
Fertilizers Production (40 CFR part 63, subparts AA & BB).
    ICR Numbers: EPA ICR Number 1790.04, OMB Control Number 2060-0361.
    ICR Status: This ICR is scheduled to expire on May 31, 2007. Under
OMB regulations, the Agency may continue to conduct, or sponsor the
collection of information while this submission is pending at OMB. An
Agency may not conduct, or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register, or by other appropriate means,
such as on the related collection instrument, or form, if applicable.
The display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: Owners/operators of affected phosphoric acid
manufacturing and phosphate fertilizer production must submit one-time
only notifications (where applicable) and annual reports on performance
test results. Semiannual reports are required. In addition, a quarterly
report is required when excess emissions occur.
    Subparts AA and BB require respondents to install monitoring
devices to measure the pressure drop and liquid flow rate for wet
scrubbers. These operating parameters are permitted to vary within
ranges determined concurrently with performance tests. Exceedances of
the operating ranges are considered violations of the site-specific
operating limits.
    The standards require sources to determine and record the amount of
phosphatic feedstock material processed or stored on a daily basis.
Respondents also maintain records of specific information needed to
determine that the standards are being achieved and maintained.
    An Agency may not conduct, or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB Control Number. The OMB Control Number for EPA's
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are
identified on the form and/or instrument, if applicable.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information are estimated to average 18
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to, or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit, or otherwise disclose the
information.
    Respondents/Affected Entities: Phosphoric acid manufacturing and
phosphate fertilizers production plants.
    Estimated Number of Respondents: 12.
    Frequency of Response: Initially, quarterly, semiannually, and
annually.
    Estimated Total Annual Hour Burden: 1,542.
    Estimated Total Annual Costs: $109,908, which includes no
annualized capital/startup costs, $11,000 in annual O&M costs, and
$98,908 in annual labor costs.
    Changes in the Estimates: There is no change in the labor hours, or
cost in this ICR compared to the previous ICR. This is due to two
considerations. First, the regulations have not changed over the past
three years and are not anticipated to change over the next three
years. Second, the growth rate for the industry is very low, negative
or non-existent, so there is no significant change in the overall
burden.

    Dated: April 6, 2007.
Robert Gunter,
Acting Director, Collection Strategies Division.
 [FR Doc. E7-7149 Filed 4-13-07; 8:45 am]

BILLING CODE 6560-50-P