[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Notices]
[Pages 42706-42708]
[FR Doc No: 2016-15589]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2016-0349; FRL-9948-17]

FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a 2-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review a set of scientific issues being considered by the
Environmental Protection Agency regarding the human health and
ecological risk assessments for SmartStax PRO (MON 89034 x TC1507 x MON
87411 x DAS-59122-7), a plant-incorporated protectant intended to
control corn rootworm through ribonucleic acid (RNA) interference.

DATES: The meeting will be held on September 27-28, 2016, from
approximately 9:00 a.m. to 5:00 p.m.
    Comments. The Agency encourages written comments be submitted on or
before September 13, 2016, to provide adequate time for the FIFRA SAP
to review and consider the comments. The Agency encourages requests for
oral comments be submitted on or before September 20, 2016. However,
written comments and requests to make oral comments may be submitted
until the date of the meeting, but anyone submitting written comments
after September 13, 2016, should contact the Designated Federal
Official (DFO) listed under FOR FURTHER INFORMATION CONTACT. For
additional instructions, see Unit I.C. of the SUPPLEMENTARY
INFORMATION.
    Nominations. Nominations of candidates to serve as ad hoc members
of FIFRA SAP for this meeting should be provided on or before August 1,
2016.
    Webcast. This meeting may be webcast. Please refer to the FIFRA SAP
Web site at http://www.epa.gov/sap for information on how to access the
meeting webcast. Please note that the webcast is a supplementary public
process provided only for convenience. If difficulties arise resulting
in webcasting outages, the meeting will continue as planned.
    Special accommodations. For information on access or services for
individuals with disabilities, and to request accommodation of a
disability, please contact the DFO listed under FOR FURTHER INFORMATION
CONTACT at least 10 days prior to the meeting to give EPA as much time
as possible to process your request.

ADDRESSES:
    Meeting: The meeting will be held at the Environmental Protection
Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA 22202.
    Comments: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2016-0349, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or

delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on
commenting or visiting the docket, along with more information about
dockets generally, is available at http://www.epa.gov/dockets.
    Nominations, requests to present oral comments, and requests for
special accommodations. Submit nominations to serve as ad hoc members
of FIFRA SAP, requests for special accommodations, or requests to
present oral comments to the DFO listed under FOR FURTHER INFORMATION
CONTACT.

FOR FURTHER INFORMATION CONTACT: Steven Knott, DFO, Office of Science
Coordination and Policy (7201M), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-0103; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be of interest to persons who are or may be required to
conduct testing of chemical substances under the Federal Food, Drug,
and Cosmetic Act (FFDCA) and FIFRA. Since other entities may also be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit CBI information to EPA through
regulations.gov or email. If your comments contain any information that
you consider to be CBI or otherwise protected, please contact the DFO
listed under FOR FURTHER INFORMATION CONTACT to obtain special
instructions before submitting your comments.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

C. How may I participate in this meeting?

    You may participate in this meeting by following the instructions
in this unit. To ensure proper receipt by EPA, it is imperative that
you identify docket ID number EPA-HQ-OPP-2016-0349 in the subject line
on the first page of your request.
    1. Written comments. The Agency encourages written comments be
submitted, using the instructions in ADDRESSES and Unit I.B., on or
before September 13, 2016, to provide FIFRA SAP the time necessary to
consider and review the written comments. Written comments are accepted
until the date of the meeting, but anyone submitting written comments
after September 13, 2016, should contact the DFO listed under FOR
FURTHER INFORMATION CONTACT. Anyone submitting written comments at the
meeting should bring 15 copies for distribution to FIFRA SAP by the
DFO.
    2. Oral comments. The Agency encourages each individual or group
wishing to make brief oral comments to FIFRA SAP to submit their
request to the DFO listed under FOR FURTHER INFORMATION CONTACT on or
before September 20, 2016, in order to be included on the meeting
agenda. Requests to present oral comments will be accepted until the
date of the meeting and, to the extent that time permits, the Chair of
FIFRA SAP may permit the presentation of oral comments at the meeting
by interested persons who have not previously requested time. The
request should identify the name of the individual making the
presentation, the organization (if any) the individual will represent,
and any requirements for audiovisual equipment. Oral comments before
FIFRA SAP are limited to approximately 5 minutes unless prior
arrangements have been made. In addition, each speaker should bring 15
copies of his or her comments and presentation for distribution to
FIFRA SAP at the meeting by the DFO.
    3. Seating at the meeting. Seating at the meeting will be open and
on a first-come basis.
    4. Request for nominations to serve as ad hoc members of FIFRA SAP
for this meeting. As part of a broader process for developing a pool of
candidates for each meeting, FIFRA SAP staff routinely solicits the
stakeholder community for nominations of prospective candidates for
service as ad hoc members of FIFRA SAP. Any interested person or
organization may nominate qualified individuals to be considered as
prospective candidates for a specific meeting. Individuals nominated
for this meeting should have expertise in one or more of the following
areas: Ecological risk assessment, human health risk assessment,
entomology, bioinformatics, RNAi technology, biotechnology, plant
breeding and genomics, and molecular biology. Nominees should be
scientists who have sufficient professional qualifications, including
training and experience, to provide expert comments on the scientific
issues for this meeting. Nominees should be identified by name,
occupation, position, address, email address, and telephone number.
Nominations should be provided to the DFO listed under FOR FURTHER
INFORMATION CONTACT on or before August 1, 2016. The Agency will
consider all nominations of prospective candidates for this meeting
that are received on or before that date. However, final selection of
ad hoc members for this meeting is a discretionary function of the
Agency.
    The selection of scientists to serve on FIFRA SAP is based on the
function of the Panel and the expertise needed to address the Agency's
charge to the Panel. No interested scientists shall be ineligible to
serve by reason of their membership on any other advisory committee to
a federal department or agency, or their employment by a federal
department or agency except EPA. Other factors considered during the
selection process include availability of the potential Panel member to
fully participate in the Panel's reviews, absence of any conflicts of
interest or appearance of lack of impartiality, independence with
respect to the matters under review, and lack of bias. Although
financial conflicts of interest, the appearance of lack of
impartiality, lack of independence, and bias may result in
disqualification, the absence of such concerns does not assure that a
candidate will be selected to serve on the FIFRA SAP. Numerous
qualified candidates are identified for each Panel. Therefore,
selection decisions involve carefully weighing a number of factors
including the candidates' areas of expertise and professional
qualifications and achieving an overall balance of different scientific
perspectives on the Panel. The Agency anticipates selecting
approximately eight ad hoc scientists to have the collective breadth of
experience needed to address the Agency's charge for this meeting.
    FIFRA SAP members are subject to the provisions of 5 CFR part
2634--Executive Branch Financial Disclosure, Qualified Trusts, and
Certificates of Divestiture, as supplemented by EPA in 5 CFR part 6401.
In anticipation of this requirement, prospective candidates for service
on FIFRA SAP will be asked to submit confidential financial information
which shall fully disclose, among other financial interests, the
candidates' employment, stocks, bonds, and where applicable, sources of
research support. EPA will evaluate the candidates' financial
disclosure forms to assess whether there are financial conflicts of
interest, appearance of a lack of impartiality, or any prior
involvement with the development of

the documents under consideration (including previous scientific peer
review) before the candidate is considered further for service on the
FIFRA SAP. Those who are selected from the pool of prospective
candidates will be asked to attend the public meetings and to
participate in the discussion of key issues and assumptions at these
meetings. In addition, they will be asked to review and to help
finalize the meeting minutes. The list of FIFRA SAP members
participating at this meeting will be posted on the FIFRA SAP Web site
at http://www.epa.gov/sap or may be obtained from the OPP Docket at
http://www.regulations.gov.

II. Background

A. Purpose of FIFRA SAP

    FIFRA SAP serves as the primary scientific peer review mechanism of
EPA's Office of Chemical Safety and Pollution Prevention and is
structured to provide scientific advice, information and
recommendations to the EPA Administrator on pesticides and pesticide-
related issues as to the impact of regulatory actions on health and the
environment. FIFRA SAP is a federal advisory committee established in
1975 under FIFRA that operates in accordance with requirements of the
Federal Advisory Committee Act (5 U.S.C. Appendix). FIFRA SAP is
composed of a permanent panel consisting of seven members who are
appointed by the EPA Administrator from nominees provided by the
National Institutes of Health and the National Science Foundation.
FIFRA established a Science Review Board (SRB) consisting of at least
60 scientists who are available to FIFRA SAP on an ad hoc basis to
assist in reviews conducted by FIFRA SAP. As a scientific peer review
mechanism, FIFRA SAP provides comments, evaluations, and
recommendations to improve the effectiveness and quality of analyses
made by Agency scientists. Members of the FIFRA SAP are scientists who
have sufficient professional qualifications, including training and
experience, to provide expert advice and recommendations to the Agency.

B. Public Meeting

    The use of RNA interference (RNAi) gene silencing technology,
particularly RNAi for pesticidal purposes to control macroorganism
pests, is a relatively recent innovation. Post-transcriptional
silencing of gene function is a very rapid process where double-
stranded RNA (dsRNA) directs sequence-specific degradation of a RNA. As
EPA anticipated receiving pesticide applications based on RNAi
technologies and identified the need to better understand the
scientific issues concerning the assessment of the risks to human
health and the environment that RNAi technologies pose, it convened a
January 28, 2014, Federal Insecticide, Fungicide, and Rodenticide Act
Scientific Advisory Panel (FIFRA SAP). This FIFRA SAP provided EPA with
scientific advice regarding the framework for assessing RNAi pesticide
products.
    On October 29, 2015, EPA registered MON 87411, a corn plant-
incorporated protectant (PIP) for seed increase/breeding purposes only
and not for commercial release, with a time limitation of 2 years and a
per-season acreage cap of 15,000 acres. In addition to Bacillus
thuringiensis (Bt) Cry3Bb1 protein, MON 87411 expresses DvSnf7 dsRNA.
Upon consumption by corn rootworm (CRW), the insect's RNAi machinery
recognizes DvSnf7 dsRNA, resulting in down-regulation of the targeted
DvSnf7 gene and leading to CRW mortality. Earlier this year, EPA
received applications from Monsanto Company and Dow AgroSciences, LLC,
requesting registration of commercial release RNAi PIPs expressing
DvSnf7 dsRNA and known by the name SmartStax PRO. SmartStax PRO also
expresses several Bt insecticidal Cry proteins.
    EPA will present the human health risk assessment conducted for
DvSnf7 dsRNA, as expressed in SmartStax PRO, and will consider the fate
of ingested dsRNA and the potential for impacts on gene expression and
the immune system. The action of a RNA interference construct relies
upon some level of sequence homology with the target gene transcript;
however, the fidelity of the sequence match may vary in some instances.
EPA will discuss the role that bioinformatic analysis may play in
understanding and predicting possible off-target effects within the
host genome, as well as in predicting nontarget effects as part of the
ecological risk assessment.
    EPA will also present an ecological risk assessment for DvSnf7
dsRNA, as expressed in SmartStax PRO, and will include descriptions of
environmental fate and nontarget exposure, data reviewed in support of
the risk assessment, risk characterization and description, and
uncertainties. The charge to the panel will request expert opinion on
completeness of the data set and uncertainties related to the risk
conclusions.

C. FIFRA SAP Documents and Meeting Minutes

    EPA's background paper, related supporting materials, charge/
questions to FIFRA SAP, FIFRA SAP composition (i.e., members and ad hoc
members for this meeting), and the meeting agenda will be available by
approximately late August. In addition, the Agency may provide
additional background documents as the materials become available. You
may obtain electronic copies of these documents, and certain other
related documents that might be available at http://www.regulations.gov
and the FIFRA SAP Web site at http://www.epa.gov/sap.
    FIFRA SAP will prepare meeting minutes summarizing its
recommendations to the Agency approximately 90 days after the meeting.
The meeting minutes will be posted to the FIFRA SAP Web site or may be
obtained from the OPP Docket at http://www.regulations.gov.

    Authority:  7 U.S.C. 136 et seq.; 21 U.S.C. 301 et seq.

    Dated: June 23, 2016.
Stanley Barone,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. 2016-15589 Filed 6-29-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: March 27, 2009 (Volume 74, Number 58)]
[Rules and Regulations]
[Page 13343-13345]
[DOCID:fr27mr09-10]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[USCG-2009-0006]
RIN 1625-AA87

Temporary Moving Security Zone; Freeport Channel Entrance,
Freeport, TX

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing temporary moving security
zones for certain vessels, for which the Captain of the Port, Houston-
Galveston, deems enhanced security measures necessary on a case-by-case
basis. These moving security zones would extend 1,000 yards ahead and
astern and 500 yards on each side of certain vessels, which will
display the international signal flag or pennant number five to signal
a security zone is established around the vessel. The moving security
zone may commence at any point after certain vessels bound for the Port
of Freeport enter the U.S. territorial waters (12 nautical miles) in
the Captain of the Port Houston-Galveston zone. These security zones
are needed to safeguard the vessels, the public, and the surrounding
area from sabotage or other subversive acts, accidents, or other events
of a similar nature. Unless exempted under this rule, entry into or
movement within these security zones would be prohibited without
permission from the Captain of the Port Houston-Galveston.

DATES: This rule is effective from 12 p.m. (noon) on January 15, 2009
until 12 a.m. on April 31, 2009.

ADDRESSES: Documents indicated in this preamble as being available in
the docket, are part of docket [USCG-2009-0006] and are available
online by going to http://www.regulations.gov, selecting the Advanced
Docket Search option on the right side of the screen, inserting USCG-
2009-0006 in the Docket ID box, pressing Enter, and then clicking on
the item in the Docket ID column. This material is also available for
inspection or copying at two locations: the Docket Management Facility
(M-30), U.S. Department of Transportation, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays and the Marine Safety Unit Galveston, 3101 FM 2004, Texas
City, TX 77591, between 8 a.m. and 4 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Lieutenant Cliff Harder, Marine Safety
Unit Galveston, Texas, at<PHONE_NUMBER>. If you have questions on
viewing the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    We did not publish a notice of proposed rulemaking (NPRM) for this
regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a NPRM, and under 5 U.S.C. 553(d)(3),
good cause exists for making this rule effective less than 30 days
after publication in the Federal Register. Publishing a NPRM and
delaying its effective date would be contrary to public interest since
immediate action is needed to reduce potential methods of attack on
vessels, waterfront facilities, and adjacent population centers located
within the zones.

Background and Purpose

    Heightened awareness of potential terrorist acts requires enhanced
security of our ports, harbors, and vessels; to enhance security, the
Captain of the Port Houston-Galveston is establishing temporary moving
security zones around escorted vessels.
    This rule would establish distinct moving security zones that may
commence at any point after certain vessels bound for the Port of
Freeport enter the 12-nautical mile U.S. territorial waters in the
Captain of the Port Houston-Galveston zone. These zones would be
established to protect waterfront facilities, persons, and vessels from
subversive or terrorist acts.

Vessels operating within the Captain of the Port Houston-Galveston zone
are potential targets of terrorist attacks, or potential launch
platforms for terrorist attacks on other vessels, waterfront
facilities, and adjacent population centers.
    Due to the potential for terrorist attacks, this rule would allow
the Captain of the Port to create moving security zones around certain
vessels as deemed necessary, on a case-by-case basis. All vessels
around which a security zone is deemed necessary will display the
international signal flag or pennant number five, to signal that there
is a security zone established around the vessel. By limiting access to
these areas, the Coast Guard is reducing potential methods of attack on
vessels, waterfront facilities, and adjacent population centers located
within these security zones. Vessels having a need to enter these
security zones must obtain express permission from the Captain of the
Port Houston-Galveston or his designated representative prior to entry.

Discussion of Rule

    The Coast Guard is establishing moving security zones for certain
vessels, for which the Captain of the Port Houston-Galveston deems
enhanced security measures necessary on a case-by-case basis. These
moving security zones will be activated for certain vessels within the
Captain of the Port Houston-Galveston zone commencing at U.S.
territorial waters through the Freeport Entrance Channel, extending
from the surface to the sea floor. These moving security zones are
established as follows: 1,000 yards ahead and astern and 500 yards on
each side of certain vessels while in transit. Unless exempted under
this rule, these moving security zones would prohibit entry into or
movement within this portion of the Captain of the Port Houston-
Galveston zone without Captain of the Port authorization. These
security zones are needed to safeguard the vessels, the public, and the
surrounding area from sabotage or other subversive acts, accidents, or
other events of a similar nature.
    All vessels not exempted under this rule would be prohibited from
entering these security zones unless authorized by the Captain of the
Port Houston-Galveston or his designated representative. In Houston,
vessels can contact the Captain of the Port Houston-Galveston through
Vessel Traffic Service Houston/Galveston on VHF Channel 5A, by
telephone at<PHONE_NUMBER>, or by facsimile at<PHONE_NUMBER>. In
Freeport, vessels can contact the Captain of the Port Houston-Galveston
through Marine Safety Unit Galveston, by telephone at<PHONE_NUMBER>, or
by facsimile at<PHONE_NUMBER>. This rule is effective from 12 p.m.
(noon) on January 15, 2009 until 12 a.m. on April 31, 2009.

Regulatory Evaluation

    This rule is not a ``significant regulatory action'' under section
3(f) of Executive Order 12866, Regulatory Planning and Review, and does
not require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    We expect the economic impact of this rule to be so minimal that a
full Regulatory Evaluation under the regulatory policies and procedures
of DHS is unnecessary. The basis of this finding is that the duration
of the security zones is limited in nature and would not create undue
delay to vessel traffic in and around the Port of Freeport.
Additionally, any other vessel wishing to enter the security zone may
request permission to do so.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. 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 rule
would not have a significant economic impact on a substantial number of
small entities.
    This rule would not have a significant economic impact on a
substantial number of small entities for the following reason: The
duration of the security zones is limited in nature and would not
create undue delay to vessel traffic in and around the Port of
Freeport.

Assistance for Small Entities

    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 rule so that they can better evaluate
its effects on them and participate in the rulemaking. 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 Lieutenant Cliff Harder at 409-
978-2705. 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.

Collection of Information

    This rule would call for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

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 or more in any
one year. Though this rule would not result in such expenditure, we do
discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule would not effect a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and would not create an
environmental risk to health or risk to safety that might
disproportionately affect children.

Indian Tribal Governments

    This 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.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that Order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule would not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Commandant Instruction M16475.lD,
which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have concluded that this action is one of a category of actions which
do not individually or cumulatively have a significant effect on the
human environment. Therefore, this rule is categorically excluded,
under section 2.B.2, figure 2-1, paragraph (34)(g) of the Instruction.
Paragraph (34)(g) covers regulations establishing, disestablishing, or
changing security zones. This rule involves temporarily establishing a
security zone in the Captain of the Port Houston-Galveston zone.
    Neither an environmental assessment nor an environmental impact
statement is required. An ``Environmental Analysis Check List'' and a
categorical exclusion are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

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

0
For the reasons discussed in the preamble, the Coast Guard proposes 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 continues to read as follows:

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 3306;
3706; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Public Law 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T818 to read as follows:

Sec.  165.T818   Moving Security Zones for Certain Vessels in Freeport
Entrance Channel, Freeport, Texas.

    (a) Location. The following areas are security zones: All waters
within the Captain of the Port Houston-Galveston Zone commencing at
U.S. territorial waters through the Freeport Entrance Channel, from
surface to bottom, one thousand (1,000) yards ahead and astern and five
hundred (500) yards on each side of any vessel within the 12 nautical
mile U.S. Territorial Waters in the Captain of the Port Houston-
Galveston zone that displays the international signal flag or pennant
number five.
    (b) Definitions. For the purposes of this section:
    Designated Representative means any U.S. Coast Guard commissioned,
warrant or petty officer who has been authorized by the Captain of the
Port, Houston-Galveston, to assist in the enforcement of the security
zone.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.33 of this part, entry into this zone is prohibited unless
authorized by the Captain of the Port Houston-Galveston or a designated
representative.
    (2) Entry into or remaining in the security zones described in
paragraph (a) of this section is prohibited for all vessels except:
    (i) Moored vessels or vessels anchored in a designated anchorage
area. A moored or an anchored vessel in a security zone must remain
moored or anchored unless it obtains permission from the Captain of the
Port Houston-Galveston to do otherwise;
    (ii) Commercial vessels operating at the waterfront facilities
within these security zones;
    (iii) Commercial vessel transiting directly to or from waterfront
facilities within these security zones;
    (iv) Vessels providing direct operational/logistic support to
commercial vessels within these security zones;
    (v) Vessels operated by the port authority or by facilities located
within these security zones; and
    (vi) Vessels operated by federal, state, county, or municipal
agencies;
    (3) All persons and vessels within the moving security zone must
comply with the instructions of the Captain of the Port Houston-
Galveston and designated on-scene U.S. Coast Guard patrol personnel.
    (4) To request permission as required by these regulations, contact
the Sector Houston-Galveston Command Center by telephone at 713-671-
5113. In Freeport, vessels should contact the Captain of the Port
Houston Galveston's designated representative for the moving security
zone on VHF Channel 16, or by telephone at<PHONE_NUMBER>.
    (d) Informational broadcasts. The Captain of the Port Houston-
Galveston will inform the public when moving security zones have been
established around certain vessels via Broadcast Notice to Mariners on
VHF channel 16 and 13.

    Dated: January 15, 2009.
William J. Diehl,
Captain, U.S. Coast Guard, Captain of the Port Houston-Galveston.
 [FR Doc. E9-6820 Filed 3-26-09; 8:45 am]


[Federal Register Volume 88, Number 76 (Thursday, April 20, 2023)]
[Notices]
[Pages 24401-24402]
[FR Doc No: 2023-08349]

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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: EG23-121-000.
    Applicants: Clearwater Wind East, LLC.
    Description: Clearwater Wind East, LLC submits Notice of Self-
Certification of Exempt Wholesale Generator Status.
    Filed Date: 4/13/23.
    Accession Number: 20230413-5176.
    Comment Date: 5 p.m. ET 5/4/23.

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

    Docket Numbers: ER22-2867-003.
    Applicants: Bluegrass Solar, LLC.
    Description: Tariff Amendment: Response to Second Deficiency Letter
to be effective 10/1/2022.
    Filed Date: 4/14/23.
    Accession Number: 20230414-5101.
    Comment Date: 5 p.m. ET 5/5/23.

    Docket Numbers: ER23-888-001.
    Applicants: New England Power Company.
    Description: Tariff Amendment: 2023-04-14 Deficiency Letter
Response to be effective 12/19/2022.
    Filed Date: 4/14/23.
    Accession Number: 20230414-5029.
    Comment Date: 5 p.m. ET 5/5/23.

    Docket Numbers: ER23-1638-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA, Service
Agreement No. 6864; Queue No. AF1-019 to be effective 3/14/2023.
    Filed Date: 4/13/23.
    Accession Number: 20230413-5165.
    Comment Date: 5 p.m. ET 5/4/23.

    Docket Numbers: ER23-1639-000.
    Applicants: Midcontinent Independent System Operator, Inc.,
American Transmission Company LLC.
    Description: Sec.  205(d) Rate Filing: Midcontinent Independent
System Operator, Inc. submits tariff filing per 35.13(a)(2)(iii: 2023-
04-14_SA 3909 ATC-City of Negaunee 1st Rev PCA (Irontown) to be
effective 6/14/2023.
    Filed Date: 4/14/23.
    Accession Number: 20230414-5017.
    Comment Date: 5 p.m. ET 5/5/23.

    Docket Numbers: ER23-1640-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  205(d) Rate Filing: 2023-04-14--Att O PSCo
Appendix 1 to be effective 4/27/2022.
    Filed Date: 4/14/23.
    Accession Number: 20230414-5059.
    Comment Date: 5 p.m. ET 5/5/23.

    Docket Numbers: ER23-1641-000.
    Applicants: Stored Solar Tamworth, LLC.
    Description: Tariff Amendment: Cancellation of Stored Solar
Tamworth, LLC MBR Tariff to be effective 4/14/2023.
    Filed Date: 4/14/23.
    Accession Number: 20230414-5070.
    Comment Date: 5 p.m. ET 5/5/23.

    Docket Numbers: ER23-1642-000.
    Applicants: Stored Solar J&WE, LLC.
    Description: Sec.  205(d) Rate Filing: NE Renewable Power, LLC MBR
Tariff to be effective 1/31/2023.
    Filed Date: 4/14/23.
    Accession Number: 20230414-5074.
    Comment Date: 5 p.m. ET 5/5/23.

    Docket Numbers: ER23-1643-000.
    Applicants: PacifiCorp.
    Description: Tariff Amendment: Notice of Termination to be
effective 6/14/2023.
    Filed Date: 4/14/23.
    Accession Number: 20230414-5095.
    Comment Date: 5 p.m. ET 5/5/23.

    Docket Numbers: ER23-1644-000.
    Applicants: Tri-State Generation and Transmission Association, Inc.
    Description: Sec.  205(d) Rate Filing: Amendment to Rate Schedule
FERC No. 35 to be effective 6/13/2023.
    Filed Date: 4/14/23.
    Accession Number: 20230414-5103.
    Comment Date: 5 p.m. ET 5/5/23.

    Docket Numbers: ER23-1645-000.
    Applicants: Virginia Electric and Power Company, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Virginia Electric and Power
Company submits tariff filing per 35.13(a)(2)(iii: VEPCO revisions to
OPEB Expense in OATT Att. H-16C Formula Rate to be effective 6/15/2023.
    Filed Date: 4/14/23.
    Accession Number: 20230414-5111.
    Comment Date: 5 p.m. ET 5/5/23.

    Docket Numbers: ER23-1646-000.
    Applicants: Virginia Electric and Power Company, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Virginia Electric and Power
Company submits tariff filing per 35.13(a)(2)(iii: VEPCO submits
revisions to OATT Att. H-16A Pt. 2 Depreciation Rates to be effective
6/14/2023.
    Filed Date: 4/14/23.
    Accession Number: 20230414-5112.
    Comment Date: 5 p.m. ET 5/5/23.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by 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: April 14, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-08349 Filed 4-19-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 99 (Tuesday, May 22, 2018)]
[Notices]
[Pages 23690-23691]
[FR Doc No: 2018-10926]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1020]

Bioanalytical Method Validation; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled
``Bioanalytical Method Validation.'' This final guidance incorporates
public comments to the revised draft published in 2013 as well as the
latest scientific feedback concerning bioanalytical method validation
and provides the most up-to-date information needed by drug developers
to ensure the bioanalytical quality of their data.

DATES: The announcement of the guidance is published in the Federal
Register on May 22, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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-2013-D-1020 for ``Bioanalytical Method Validation.'' Received
comments 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.
     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.gpo.gov/fdsys/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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or Policy and
Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and
Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Brian Booth, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>; or Olutosin
(Remi) Idowu, Center for Veterinary Medicine, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Bioanalytical Method Validation.'' The guidance describes
the elements of bioanalytical method development and validation that
are needed to ensure the quality of an assay and the reliability of the
data it generates. The concepts apply both to chromatographic assays as
well as ligand-binding assays. This guidance incorporates the latest
scientific practices in method validation, newer science on incurred
sample reanalysis, the use of new analytical platforms, the repurposing
of diagnostic kits for drug development, and general advice on
bioanalytical method development and validation for biomarkers in drug
development.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Bioanalytical Method Validation.'' It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 58 have been
approved under OMB control number 0910-0119; the collections of
information in 21 CFR part 312 have been approved under OMB control
number 0910-0014; the collections of information in 21 CFR part 314
have been approved under OMB control number 0910-0001; the collections
of information in 21 CFR part 514 have been approved under OMB control
number 0910-0032; the collections of information in 21 CFR part 511
have been approved under OMB control number 0910-0117; and the
collections of information in section 360b(n)(1) (21 U.S.C 512(n)(1))
of the Federal Food, Drug and Cosmetic Act have been approved in OMB
control number 0910-0669.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: May 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10926 Filed 5-21-18; 8:45 am]
 BILLING CODE 4164-01-P