General Background and Legal Authority

History

The Bureau of Labor and Industry, now known as the Bureau of Labor
Standards, was established in 1873 as an activity of the Secretary of
State. In 1971, Title 26 of the Maine Revised Statutes was enacted
defining the power and duties of the Director of the Bureau of Labor
Standards under Chapter 3, Subsection 42.  Chapter 6, Subsection 565
defines the powers and duties of the Board of Occupational Safety and
Health and states that the Board shall formulate rules that will, at a
minimum, conform to federal standards of occupational safety and health,
so that the state program could eventually be approved as a State and
Local Government Only State Plan. Since 1971, the Maine Department of
Labor, Bureau of Labor Standards, Workplace Safety and Health Division,
has adopted standards and performed inspections in the public sector
(State, county, and municipal employees) as outlined under the
provisions of the State's existing enabling legislation.

Existing Legal Basis

The basic legislation is in place and is included in Title 26 of the
Maine Revised Statutes.

The Maine statutes establish the Bureau of Labor Standards and its
duties, complaint inspection procedures, nondiscrimination requirements,
methods of compelling compliance, the review system for contested cases,
employee access to information, prohibited actions and sanctions,
inspection scheduling and the voluntary compliance program.  The
statutes include the employer’s and employees’ duties, recordkeeping
requirements, adoption of the federal Occupational Safety and Health
Administration (OSHA) standards and variances from rule requirements.

In 2012, Maine began working on a State and Local Government Only State
Plan and submitted a draft Plan to OSHA in February of 2013. OSHA’s
review findings were detailed in various memoranda and other documents.
OSHA determined that the Maine statutes, as structured, and the proposed
State Plan necessitated minor changes in order to meet the State and
Local Government Only State Plan approval criteria in 29 CFR 1956.
Amendments to Maine Revised Statutes, Title 26 were proposed and enacted
by the Maine Legislature and signed into law by the Governor in 2014.
The amended legislation provides the basis for establishing a
comprehensive occupational safety and health program applicable to the
state and local government employees in the state.

Employee Coverage

The Maine State Plan will cover public sector employees throughout the
state.  A public employee is defined as a person, including a minor
whether lawfully or unlawfully employed, who is employed or permitted to
work by the state, a state agency, county, municipal corporation, and
school district.  Volunteers under the direction of a public employer or
other public corporation or political subdivision will also be covered.

Employees covered, as of December 2014:

      State Employees –                  23,169

Volunteers –                            unknown number

County Employees –

Municipal Employees –

University System –

College System –                    58,267

Public Schools –

Quasi-State Agencies –          ______

TOTAL                        81,436 plus volunteers

3.  NAICS Code

State Agencies

610000

620000

621000

622000

623000

624000

921000

922000

922120

922140

483114

541712

Municipal Government

220000

221300

237000

562000

610000

620000

713900

921000

922000

922120

922160

Description

Educational Services

Health & Social Service

Ambulatory Health Care Services

Hospitals

Nursing & Residential Care Facilities

Social Assistance

Executive, Legislature & Other

General Government Support Justice

Public Order & Safety

Police Protection

Correctional Facilities

Ferry Service

State Owned Farms

Utilities

Water, Sewage & Other Systems

Public Works – Street & Highway

Waste Management & Remediation Services

Educational Services

Health Care – Social Services

Parks & Recreation Industries

Executive, Legislative & Other general Government Support

Justice, Public Order & Safety

Police Protection

Fire Protection

The definition of public employee does not include students, or those
incarcerated or involuntarily/voluntarily committed in public
institutions.

Issue Coverage

OSHA is responsible for private sector safety and health issues and has
no jurisdiction over public sector employees.

The Maine Department of Corrections or the local governing body handles
any health and safety issues with regards to incarcerated individuals in
the Maine prison and jail system.  The Maine Department of Human
Services is responsible for ensuring the health and safety of
involuntarily or voluntarily committed individuals in public mental
health institutions.   The Maine Department of Public Health and the
Maine Department of Education have some jurisdiction over health and
safety issues in public buildings and in public educational institutions
where students or parents are affected.

The Maine provisions apply to all public employers and their employees
except for working conditions of employees with respect to which federal
agencies.  State agencies acting under Section 274 of the Atomic Energy
Act of 1954, as amended (42 USC 2021), exercise statutory authority to
prescribe or enforce standards or regulations affecting occupational
safety and health.  The Maine State Plan will cover all places of public
employment.

Designated State Agency

State Designee

The Maine Department of Labor, Bureau of Labor Standards is designated
to ensure that public sector employees are provided with a safe and
healthy work environment, free from recognized hazards. The Director of
the Bureau or his or her authorized representative is the designee for
the Maine State Plan.

Concurrent Authority and Responsibilities

The Bureau has sole authority for administration of the occupational
safety and health provisions of the aforementioned acts.

Divisions within the Bureau include:

Workplace Safety and Health Division

Technical Services Division

Wage and Hour Division

The Workplace Safety and Health Division will be the primarily
responsible division. These other two divisions are separate with
independent management and will not detract significantly from the
resources and priorities assigned to the administration of the Maine
State Plan.  Any indirect costs associated with duties performed by
these divisions will be explicitly outlined in the State Plan.

Delegation

The Bureau does not delegate any authority to any other state agency
with regards to occupational safety and health enforcement issues.

Standards and Variances

Identical Standards

The Occupational Safety and Health Board formulates and adopts
reasonable rules, pursuant to Title 26, chapter 6, subchapter 365 of the
Maine Revised Statutes for safe and healthful working conditions

The rules so formulated shall at a minimum conform to federal standards
for occupational safety and health, so that the state program can be
federally funded as a public employee only safety and health program.

The Board will adopt the most current OSHA standards through rulemaking.
The estimate for completion of this adoption is November 2016, and the
standards will be in effect 90 days after adoption.

Procedures for Identical Standards

All federal occupational safety and health standards shall become rules
of the Bureau, within six months after their federal promulgation date,
unless an existing state standard is at least as effective.

In all rulemaking, the Board follows the Maine Administrative Procedures
Act.  During the first notice period, the Board shall accept from any
interested persons, data, views, arguments, or comments either orally,
in writing or both as stated in the Maine Administrative Procedures Act.

The Board shall hold a public hearing on the proposed rulemaking during
the first notice period if the Board finds that a public hearing would
facilitate the submission of views or comments that might not otherwise
be submitted or the Board receives a request for a public hearing.

(MRSA Title 26, chapter 6, subchapter 565; Title 5, chapter 375)

Procedures for Alternative Standards

The Board has the authority to adopt alternative or different
occupational health and safety standards where no federal standards are
applicable to the conditions or circumstances or where standards that
are more stringent than the federal are deemed advisable.  Prior to the
development and promulgation of alternative standards or the
modification or revocation of existing standards, the Board will
consider:  expert technical knowledge, submissions from interested
persons and the opportunity for interested persons to participate in any
hearing.  Alternative standards will be published and reviewed using the
aforementioned general rulemaking adoption process.  While the Board has
this authority it is rarely used and there are currently no new
alternative standards being proposed by the Division.

(MRSA Title 26, chapter 6, subchapter 565)

Emergency Temporary Standards

The Governor of the State of Maine has the authority to establish
emergency temporary standards where public employees may be exposed to
unique hazards for which existing standards do not provide adequate
protection.

Emergency rulemaking procedures are outlined in the Maine Administrative
Procedures Act. An emergency is defined as the existence of any
situation that the Board finds reasonably constitutes a threat to the
public interest, safety, or welfare.  If the Board finds that an
emergency exists which requires adoption of a rule in fewer days than is
outlined in the general rulemaking guidelines and states in writing its
reasons for that finding, it may adopt an emergency rule without prior
notice or hearing upon filing a notice of emergency rulemaking.  The
text of the emergency rule shall be published in the Maine Register.  An
emergency rule becomes effective immediately upon filing or at a stated
date less than 10 days thereafter.  The Bureau will take reasonable and
appropriate measures to make emergency rules known to the persons who
may be affected by them.

Such temporary emergency standards shall be effective until superseded
by a permanent standard but in no event for more than 90 days from its
date of publication.

If OSHA promulgates an emergency temporary standard, Maine will adopt
the same within 30 days of the federal notice.

(MRSA Title 5, chapter 12, subchapter 2, section 8054)

Issues to Be Addressed by Standards

All OSHA standards have been adopted by the Board.  Additionally, the
Board of has adopted standards that are more stringent than current OSHA
standards in two instances: respiratory protection and video display
terminals.

Assurance for Continued Effectiveness

Maine commits to adopt permanent standards within six months of the
promulgation of the federal regulation, unless the state already has in
place an existing standard that is at least as effective as the federal
standard.  The Board will adopt emergency temporary standards
promulgated by the OSHA within 30 days of federal notice.  Such
temporary emergency standards shall be effective until superseded by a
permanent standard, but in no event for more than six months from the
date of their publication.

(MRSA Title 26 Chapter 6, Subsection 565; Title 5, Chapter 375)

Procedures for Granting Variances

Any affected employer may apply to the director for order for a variance
from a standard promulgated under this chapter. Affected employees shall
be given notice of each application and an opportunity to participate in
a hearing. The director shall issue the order if he determines on the
record, after a hearing and, where appropriate, an inspection, that the
proponent of a variance has demonstrated by a preponderance of the
evidence that the conditions, practices, means, methods, operations or
processes used or proposed to be used by an employer will provide
employment and places of his employment to his employees which are as
safe and healthful as those which would prevail if he complied with the
standard. Such an order may be summarily revoked by the director on his
own motion or modified or revoked by the director upon application by an
employer or employee in the manner prescribed for its issuance.

Any person aggrieved by an order of the director may appeal, at any
time, from the order to the board under the process established in
section 568.

(MRSA Title 26, Chapter 6, Subsection 571, Maine FOM)

Enforcement

Regulatory Basis for Enforcement Program

Chapter 6, Subsection 566 of the Maine Revised Statutes authorizes the
Director of the Bureau, or his or her representatives, in the Bureau to
perform any necessary inspections or investigations.  The Bureau
designates the Division of Workplace Safety and Health to carry out
these provisions.

(MRSA Title 26, Chapter 6, Subsection 566)

The Bureau Director shall enforce the occupational safety and health
standards and rules promulgated under the Health and Safety Act and any
occupational safety and health laws relating to the inspection of places
of employment, and shall visit and inspect, as often as practicable, the
public sector workplaces in Maine.

(MRSA Title 26, Chapter 3, Subsection 44)

Inspection Procedures

The Bureau has the authority to inspect any work place where work is
being performed by an employee of a public employer in order to enforce
the occupational safety and health standards. The details of the
inspection procedures are identified in the Maine Field Operations
Manual (MFOM).

Each inspection involves determining the scope of the inspection, the
conduct of the inspection, an opening conference, the review of records,
a walk-around inspection and a closing conference.   The scope of the
inspection depends upon the type of inspection and is either
comprehensive or a partial scope inspection.

The inspector will conduct the inspection during regular working hours
and will present Bureau credentials.  The inspectors are awarded the
right of entry without delay and at reasonable times.  If the public
employer refuses entry or hinders the inspection process in any way, the
inspector has the right to terminate the inspection and initiate the
compulsory legal process and/or obtain a warrant for entry. The
inspector has the right to interview all parties and review records as
they relate directly to the inspection.

(MRSA Title 26, Chapter 3, Subsection 44; Maine FOM)

The Director has the power to issue subpoenas for and compel the
attendance of witnesses and the production of pertinent books, papers,
documents and other evidence as needed to render a final order.  The
Director also has the authority to hear testimony, receive evidence, and
take or cause to be taken depositions of witnesses.

(MRSA Title 26, Chapter 3, Subsection 43)

Advance notice of any inspection, without permission of the Bureau
Director, is subject to by penalty of not less than $500 or more than
$1,000 or by imprisonment for not more than 6 months, or both.

(MRSA Title 26, Chapter 3, Subsection 46)

The opening conference will detail the scope of the inspection to the
employer and employee representatives.  Copies of complaint forms, minus
the complainant’s name, and requests for applicable records are
usually included in the opening conference.

The inspector will conduct a closing conference with the all affected
parties to discuss any findings, abatement details and verification
requirements, and employee discrimination prohibitions.

(Maine FOM)

During the walk-around inspection, representatives of the employer and
employees are allowed to accompany the inspector throughout the
inspection process as long as it does not interfere with the inspection
process itself.

(MRSA Title 26, Chapter 3, Subsection 44a)

A Superior Court in the county in which the imminent danger is alleged
to exist shall have jurisdiction, upon petition of the director, to
restrain any conditions or practices in any place of employment subject
to section 45 which are such that a danger exists which will reasonably
be expected to cause death or serious physical harm immediately or
before the imminence of such danger can be eliminated through the
enforcement procedures otherwise provided by this chapter.

(MRSA Title 26, Chapter 3, Subsection 49)

Complaint Procedures

Any employee or a representative of an employee of the State, a state
agency, county, municipal corporation, school district or other public
corporation or political subdivision who believes that a violation of an
occupational safety or health standard exists that threatens physical
harm or that an imminent danger exists may request an inspection by
giving notice to the director or his authorized agent of such violation
or danger. Except in cases of imminent danger, any such notice shall be
in writing, shall set forth with reasonable particularity the grounds
for the notice, shall be signed by the employee or his representative
and a copy shall be provided the employer or his agent no later than the
time of the inspection, except that, upon the request of the person
giving such notice, his name and the names of individual employees
referred to therein shall not appear in such copy or upon any record
published, released or made available in any other respect. If upon the
receipt of such notification, the director or his authorized agent
determines that there are reasonable grounds to believe that such
violation or danger exists, he shall make a special inspection as soon
as practicable to determine if such violation or danger exists. If the
director or his authorized agent determines that there are no reasonable
grounds to believe that a violation or danger exists, he shall notify
the employee or representative of the employee in writing of such
determination.

If the complaint is deemed to be invalid by the receiving officer (i.e.,
no signature, not an employee, not covered by state law) notice will be
sent to the complainant of the reasons. If the complaint is valid but
not covered directly by the Bureau, it will be forwarded to the
appropriate regulating body. Verbal complaints will be handled on a
case-by-case basis by the Division management staff and decisions to
inspect or notify will be rendered based on degree of hazard, number of
affected employees and past history. Every effort will be made to
formalize oral complaints, including seeking further clarification of
the hazard, working conditions, locations, etc.  An alternative
enforcement mechanism that includes administrative orders may be used
for informal complaints.

(MRSA Title 26, Chapter 3, Subsection 50; Maine FOM)

Nondiscrimination Protections

Maine has a Whistleblower’s Protection Act poster. It states:

 It is illegal for your employer to fire you, threaten you, retaliate
against you or treat you differently because:

You reported a violation to the law.

You are a healthcare worker and you reported a medical error.

You reported something that risks someone’s safety and health.

You have refused to do something that will endanger your life or someone
else’s life and you have asked your employer to correct it; or

You have been involved in an investigation or hearing held by the
government.

In addition, Title 26, Chapter 6, Subsection 570 of the Maine Revised
Statutes outlines the provisions that an employer cannot discharge or in
any manner discriminate against an employee for filing a complaint,
testifying, or otherwise acting to express rights granted by the Maine
Revised Statutes.

Any employee who believes that he or she has been discharged or
otherwise discriminated against in violation of this section may, within
30 days after the alleged violation occurs, file a complaint with the
Director, alleging discrimination. If upon investigation, the Director
determines that the provisions of this chapter have been violated, the
Director shall bring an action in Superior Court for all appropriate
relief, including rehiring or reinstatement of the employee to their
former position with back pay. Within 90 days of the receipt of a
complaint filed under this section, the Director shall notify the
complainant of his or her determination.  This determination does not
preclude the complainant from filing a new whistleblower complaint if
the employee believes discrimination has occurred after the final
determination.

Methods for Compelling Compliance

The State of Maine “Field Operations Manual” describes the
procedures for issuing citations and proposed penalties.  If the
inspector believes that a violation of a safety and health standard
exists, he or she will issue a written citation report with reasonable
promptness.  This citation will describe the nature of the violation,
including reference to the appropriate regulation and fix a reasonable
time for the abatement of the violation.  The employer is required to
post the citation at or near the place the violation occurred until it
is abated or three days, whichever is later.  No citations will be
issued after the expiration of six months following the occurrence of
any violation.  Some modifications of the citations are allowed if an
interested party provides significant evidence of their case and it is
accepted by the Director.

(MRSA Title 26, Chapter 3, Subsection 45; Maine FOM)

The employer shall provide documentation of abatement or a follow-up
inspection will be scheduled after the abatement time frame has expired.
 A written response from the employer will be evaluated by the Division
for completeness and appropriateness in relation to the citation.  If
the written response is inadequate, a follow-up inspection can still be
scheduled after the abatement timeframe.  The results of the follow-up
inspection will produce a report that documents any corrective measures
taken by the employer.  This report will be sent to the complainant if
the original inspection was initiated by a complaint.  The complainant
can refute or question any abatement measure by providing documentation
of such if not personally witnessed by the inspector.

If the Director issues a citation, he or she shall within ten days of
receipt of report, notify the employer by certified mail of any monetary
sanctions to be taken.  In Maine for the public sector, monetary
penalties are issued for serious citations.   The Director has
discretionary authority for civil penalties of up to $1,000 per day the
violation continues for repeat and willful violations. Serious and
other-than-serious violations may be assessed a penalty of up to $1,000
per violation and failure-to-correct violations may be assessed a
penalty of up to $1,000 per day.  In addition, criminal penalties can be
issued to public employers who willfully violate any standard, rule or
order. .  An alternative enforcement mechanism that includes
administrative orders may be used in limited circumstances,

(MRSA Title 26, chapter 3, Subsection 46)

Review System for Contested Cases

Informal reviews can be held at the Division management level prior to a
formal contest.  Interested parties can levy their concerns over
severity of citation, amount of penalty or legitimacy of concerns and
the Division manager will render his or her decision and notify all
parties of his pre-contest review.  The accepted request for a hearing
will stay the abatement time frame until satisfactory judgment is
rendered.

(Maine FOM)

Any public employer or representative thereof who receives a citation, a
proposed assessment of penalty, or a notification of failure to correct
a violation may within 15 working days from receipt of the notice
request in writing a hearing before the Board of Occupational Safety and
Health for an appeal from the citation order, notice of penalty or
abatement period.  Any public employee or representative thereof may
within 15 working days of the issuance of a citation file a request in
writing for a hearing before the Board for an appeal from the citation
on the ground the period of time fixed in the citation for abatement is
unreasonable.  The Board will then schedule a hearing within a
reasonable time after receipt of the request and shall notify all
interested parties.  The Director of the Bureau will remain responsible
for the enforcement process, including the issuance of citations and
penalties, and their defense, if contested. All interested parties are
allowed to participate in the hearing and contribute to the Board’s
final decision.  The Board shall affirm, modify, or vacate the citation
or proposed penalty or direct other appropriate relief.

(MRSA Title 26, chapter 6, Subsection 568; ME CMR 12-179, Chapter 1)

Any party adversely affected by a final violation order or determination
has the right to appeal and obtain a judicial review by the Superior
Court.  This complaint for review must be filed within 10 days after the
entry of the order pursuant to the Bureau rules, its amendments and
modifications thereof.

(MRSA Title 26, chapter 6, Subsection 568)

Employee Access to Information

Title 26, Chapter 3, Subsections 44 and 45 of the Maine Revised Statutes
requires public employers to maintain accurate records regarding
occupational safety and health.  The employees and/or the
representatives have the right to observe toxic exposure monitoring and
have access to the records thereof.  The public employer must also
inform the employees of protections and obligations, and must post
copies of citations.

(MRSA Title 26, Chapter 4, Subsection 44 and 45)

Other Prohibited Actions and Sanctions

Title 26, Chapter 3, Subsection 46 of the Maine Revised Statutes states
that any person who gives advance notice of any inspection to be
conducted pursuant to this chapter without authority from the Director
shall be punished by a penalty of not less than $500 nor not more than
$1,000 or by imprisonment for not more than six months or both.  Any
employer who violates any of the posting requirements, as prescribed in
section 45, shall be assessed a penalty of not more than $1,000 for each
violation.  Whoever, being duly summoned under section 43, willfully
neglects or refuses to attend, or refuses to answer any question
propounded to him concerning the subject of such examination as provided
in said section 43, or whoever, being furnished by the director with a
written or printed list of interrogatories, neglects or refuses to
answer and return the same under oath, shall be punished by a fine of
not less than $25 nor more than $100, or by imprisonment for not more
than 30 days, or by both.

(MRSA Title 26, Chapter 3, Subsection 46)

Inspection Scheduling System

The priority for assignment of staff resources for hazard categories
will be the duty of Division management and based upon inspection
category, the type of hazard, the perceived severity of hazard and the
availability of resources.  The enforcement inspection priority is
imminent danger, fatality/catastrophe, complaint, and general/follow-up.
 All advisories, training, educational and program evaluations will be
conducted as time and scheduling allows. Any federal special emphasis
programs will be evaluated for applicability in the public sector and
adopted if necessary as part of a targeted inspection program by the
Bureau.   The Bureau will use inspection data to establish a targeted
inspection program for the public sector sites in Maine.

(Maine FOM)

Voluntary Compliance Program

The Bureau provides and conducts educational programs for public
employees specifically designed to meet the regulatory requirements and
needs of the public employer.  Consultations, including site visits,
compliance assistance and training classes, are individualized for each
work site and tailored to the public employer’s concerns.  Training
topics include, but are not limited to, bloodborne pathogens, hazard
communication, confined space entry, trenching/shoring, recordkeeping,
slips/trips/falls, laboratory safety and lockout/tagout, and electrical
safety.  Public agencies are encouraged to develop and maintain their
own safety and health programs as an adjunct to but not a substitute for
the Bureau enforcement program.

The public sector consultation program currently exists under the
Bureau.

The Bureau has developed the SHAPE (Safety and Health Award for Public
Employers) to recognize public employers with an excellent safety and
health program. SHAPE exempts public employers from programed
inspections for up to two years and can be extended up to four years on
subsequent renewals, depending on the results of re-inspections. This
program was patterned after the SHARP program.

Laboratory Services

The Bureau utilizes only certified laboratories to analyze and assist in
interpreting sampling results via contractual services.  Current
contract laboratory services are with Wisconsin Laboratory. This is the
same laboratory used by the Maine 21(d) consultation program.  The
laboratory certifications are kept on file.

Assurances for Continued Effectiveness

The Bureau is dedicated to ensuring that public sector workers in Maine
are afforded the same protections and rights as those in the private
sector in all manners pursuant to their occupational safety and health.
In doing so, the Bureau will respond  to all changes in the federal
program and make independent changes in a manner that will be “at
least as effective” as the federal policy and practice as mandated by
state statute.

(MRSA Title 26, Chapter 6, Subsection 565)

Recordkeeping and Reports

Record and Report Requirements

Title 26 sets out the provision for the Bureau to require public
employers to maintain accurate records of and to make reports on,
work-related deaths, injuries and illnesses.  Such records are available
to any state agency requiring them and are held as confidential.

The records of occupational injuries and illnesses must be completed and
maintained in accordance with the applicable provisions outlined in
Chapter 6 of the Code of Maine Rules (ME CMR 12-179, Chapter 6) by the
employer for every occupational death, every nonfatal occupational
illness, and every nonfatal occupational injury that results in death,
loss of consciousness, days away from work, restricted work activity or
job transfer, or medical treatment beyond first aid.

The employer shall maintain in each workplace an OSHA 300 log of all
recordable occupational injuries and illnesses for that workplace.
Within seven calendar days after receiving information about a case, the
employer shall:  decide if the case is recordable, determine if it is a
new case or a recurrence of an existing one, establish whether the case
was work-related, and decide whether to fill out the OSHA 301, the Maine
Workers’ Compensation Commission form, or a suitable substitute that
contains the same information as these First Report of Injury forms.
The OSHA 300 log and its supplementary information must be retained for
five years by the employer.

An annual summary of work-related injuries and illnesses for each
workplace must be posted on the OSHA 300A form from February 1 to April
30 of the year following the year covered by the form.  It must be
posted in a conspicuous location where employees have the opportunity to
view it and it must be certified by an executive of the state or local
agency.  This annual summary must be retained for five years.  Knowingly
falsifying this document can result in a fine.

(MRSA Title 26, chapter 3, Subsection 44; ME CMR 12-179, Chapter 6)

Report of Fatalities

MRSA Title 26, Chapter 1, Subsection 2 requires that any person in
charge of any workplace as defined in this section provided by the
State, a state agency, a county, a municipal corporation, a school
district or other public corporation or political subdivision shall,
within 8 hours after the occurrence, report to the Director of the
Bureau (or designee)  the death of any person in the workplace or on the
premises, stating as fully as possible the cause of the death and the
place where the deceased person has been sent and supplying other
information relative to the death hat may be required by the Director
who may investigate the causes of the death and require such precautions
to be taken as will prevent the recurrence of similar events. A
statement contained in any such report is not admissible in evidence in
any action arising out of the death reported.

(MRSA Title 26, Chapter 1, Subsection 2)

Report of Serious Physical Injuries

MRSA Title 26, Chapter 1 Subsection 2 requires the person in charge of
any workplace as defined in section 1 provided by the State, a state
agency, a county, a municipal corporation, a school district or other
public corporation or political subdivision to, within 24 hours after
the occurrence, report

to the Director of the Bureau (or designee) all serious physical
injuries requiring immediate hospitalization sustained by any person in
the workplace or on the premises, stating as fully as possible the
extent and cause of the injury and the place where the injured person
has been sent and supplying other information relative to the injury
that may be required by the Director who may investigate the causes of
the injury and require such precautions to be taken as will prevent the
recurrence of similar events.  Serious physical injury is defined to
mean an incident that results in amputation, loss or fracture of a body
part or that results in immediate hospitalization.  A statement
contained in any such report is not admissible in evidence in any action
arising out of the accident reported.

(MRSA Title 26, Chapter 1, Subsection 2)

The Bureau of Labor Statistics (BLS) receives fatality and injury
information from throughout the state, including the public sector.  The
Maine State Plan agrees to participate in the BLS survey.

Management Information Systems

The current management information system is a Progress Database
application for reporting requirements.  The site information is updated
with each inspection or activity at that site.  Information can be
retrieved as far back as ten years.  Hard copies of general reports are
retained for 10 years and then destroyed according to Maine’s records
retention schedule.  Complaint inspections are assigned by Division
management based upon type of concern (safety or health) and location
(county).  The individual inspectors have the report generating programs
on laptop computers in the field.

Maine will join the OIS system within 90 days of plan approval,
including the implementation of all hardware, software, and adaptations
as necessary.

Form and Content of Reports

The Bureau shall provide quarterly reports to the Assistant Secretary of
OSHA within 10 days of the close of the quarter unless otherwise
directed.  Detailed inspection information including type, number,
region, citations and inspector will be provided along with special
reports on any fatalities or serious injuries. The Bureau will report on
its quarterly progress in meeting annual performance plan goals.
Quarterly performance will also be measured by the State Activities
Mandated Measures (SAMM) report.  Some of the Division’s measures of
performance and output will include number of inspections by type,
turnaround time on reporting, follow-up compliance and response times.
It is anticipated that the results of the State of Maine’s efforts
will be shown through lower injury/illness rates in the State of Maine
and fewer fatalities/catastrophes in the public work force.

Personnel

Sufficient Numbers of Personnel

The Workplace Safety and Health Division currently has 18 employees, of
which, 2 full-time equivalent positions (FTEs) are dedicated to public
sector enforcement. In addition, the Division Director, Program Manager
and System Administrator allocate part of their time to enforcement
program.

Within six months of the approval of the State Plan, Maine will fully
implement and staff the enforcement program separate from the public
sector consultation program. The Division will consist of two safety
enforcement safety officers, one health enforcement officer, three
safety consultants and one health consultant. In addition, the Division
Director, Program Manager and System Administrator will increase their
time allocated to the State Plan.    One health specialist will be
transferred from consultation to enforcement.  An organization chart is
included in Appendix F. Discrimination cases will be assigned to
enforcement officers who have completed the necessary training as a
collateral duty.

Organization of Staff

Director, Bureau of Labor 							    0%

Director, Workplace Safety and Health Division				  50%

Program Manager, Workplace Safety and Health Division			  80%

Two FTE’s – Public Sector Enforcement Officers –Safety			100%

One FTE’s – Public Sector Enforcement Officer – Health			100%

Three FTE’s – Public Sector Consultants – Safety				100%

One FTE’s – Public Sector Consultant – Health				100%

System Administrator								  50%

OIS/Learning Link Coordinator						  20%

Qualified Staff Requirements

The Division of Workplace Safety and Health job descriptions are
included in Appendix F.  A comprehensive training program will be
developed for both present and newly hired employees in the Division.
This training will be conducted by the OSHA Training Institute and will
include other professional courses as they are available.
State-specific training will be provided to detail the inspection
protocols as well as the reporting requirements.

State’s Merit and Hiring Systems

The Maine Merit System conforms to the standards set forth in the Merit
System of Personnel Administrations, 45 CFR Part 70 and its amendments
and any standards of the U.S. Civil Service Commission, pursuant to
Section 208 of the Intergovernmental Personnel Act of 1970 and its
amendments.

The proposed staffing levels and changes will allow the State Plan to be
at least as effective as OSHA.

The Bureau is committed to equal employment opportunity in its staffing
and its service to the public.  The policy of this Bureau is to comply
with the laws of the State of Maine and United States of America to
assure that there will be no discrimination in employment based on race,
color, religion, sex, age, national origin or handicapped conditions.
The Affirmative Action Plan is included in the application document and
it has the endorsement of the Director and managerial staff who will
continue to make concerted efforts to achieve the goals outlined in the
Plan.

Budget and Funding

Commitment of Adequate Funds

The Bureau of Labor Standards enforcement program has been fully and
consistently funded since 1972.  The General Revenue Fund (GRF) of Maine
is the main source of funding for this program.  The state program will
use this level of funding as a 50/50 match with the federal monies to
ensure that the Maine program is at least as effective as the federal
OSHA program.  Public sector consultation will use Safety Education
Training Fund (SETF) funding as a 50/50 match.  This fund receives
monies from Workers’ Compensation assessment.  The proposed budget
allocation for the developmental years of the Maine State Plan program
is included.

Comprehensive Developmental Schedule:

The Maine State plan is developmental.  The following is a schedule of
major developmental steps (benchmarks) as provided in the plan:

Developmental Step 1: Provide a comparison of ME CMR 12-179, Chapter 6
to 29 CFR 1904.

Expected date of completion: October 2015

Developmental Step 2: Adopt regulations equivalent to 29 CFR 1905, or
provide citations to currently existing equivalent regulations.

Expected date of completion: May 2016

Developmental Step 3: Adopt regulations equivalent to 29 CFR 1977, or
provide citations to currently existing equivalent regulations.

Expected date of completion: May 2016

Developmental Step 4: Enact revised legislation that revises 26 MRSA
§§ 2 and 44.

Expected date of completion: June 2015

Developmental Step 5: Provide a comparison of alternative standards that
Maine has adopted to federal standards.

This has already been provided for respiratory protection, so only the
video display terminal standard comparison will need to be provided.

Expected date of completion: February 2016

Developmental Step 6: Provide an outline of procedures for the on-site
public-sector consultation (29 CFR 1908) program or a timeline for their
development.

Expected date of completion: November 2016

Developmental Step 7: Develop a 5-year strategic plan and an annual
performance plan.

Expected date of completion: October 2015

Developmental Step 8: Update and revise, as necessary, the Maine OSHA
Field Operations Manual.

Maine will review and revise its Field Operations Manual (FOM). The
current Maine 23(g) FOM was adopted directly from the OSHA FOM. Sections
particular to Maine have been incorporated.  The FOM, in conjunction
with the Maine statutes, will ensure inspections are at least as
effective as 29 CFR 1903.The FOM will be reviewed on an annual basis.

Expected date of completion: January 2016

Developmental Step 9: Develop a plan for transitioning to the OSHA
Information System (OIS)

Maine will develop, in conjunction with OSHA, a transition plan for
joining the OIS. Maine will utilize the expertise of the OIS/Learning
Link Coordinator (currently on 21(d) staff, but will charge 20% of time
to the 23(g) grant in the future) to assist with training and to
incorporate Maine statutes and rules that need to be incorporated.

Expected date of completion: December 2015

Developmental Step 10: Determine whether adoption of 29 CFR parts 1915,
1917, and/or 1918, or equivalents, is appropriate, and if so, adopt the
appropriate regulations.

Expected date of completion: March 2016

  PAGE   \* MERGEFORMAT  4


[Federal Register Volume 87, Number 43 (Friday, March 4, 2022)]
[Notices]
[Pages 12523-12526]
[FR Doc No: 2022-04562]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94325; File No. SR-C2-2022-005]

Self-Regulatory Organizations; Cboe C2 Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Relating
To Modify How Drill-Through Price Protection Applies to Users' Orders
When Multiple Stop (Stop-Loss) and Stop-Limit Orders Are Triggered by
the Same Price

February 28, 2022.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on February 17, 2022, Cboe C2 Exchange, Inc. (the ``Exchange'' or
``C2'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Exchange
filed the proposal as a ``non-controversial'' proposed rule change
pursuant to Section 19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-
4(f)(6) thereunder.\4\ The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe C2 Exchange, Inc. (``C2'' or the ``Exchange'') is filing with
the Securities and Exchange Commission (the ``Commission'') a proposal
to modify how drill-through price protection applies to Users' \5\
orders when multiple Stop (Stop-Loss) and Stop-Limit orders are
triggered by the same price. The text of the proposed rule change is
provided in Exhibit 5.
---------------------------------------------------------------------------

    \5\ The Term ``User'' shall mean any Trading Privilege Holder
(TPH) or Sponsored User who is authorized to obtain access to the
System pursuant to Rule 5.5.
---------------------------------------------------------------------------

    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/options/regulation/rule_filings/ctwo/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements

concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The purpose of this rule filing is to amend current Rule
5.34(a)(4), Order and Quote Price Protection Mechanisms and Risk
Controls, to add new Rule 5.34(a)(4)(E), which modifies what the drill-
through price will be for Stop (Stop-Loss) \6\ and Stop-Limit \7\
orders when multiple Stop and Stop-Limit orders are triggered by the
same stop price specified by Users.
---------------------------------------------------------------------------

    \6\ A ``Stop (Stop-Loss)'' order is an order to buy (sell) that
becomes a market order when the consolidated last sale price
(excluding prices from complex order trades if outside of the NBBO)
or NBB (NBO) for a particular option contract is equal to or above
(below) the stop price specified by the User. Users may not
designate a Stop Order as All Sessions. Users may not designate bulk
messages as Stop Orders. A User may not designate a Stop order as
Direct to PAR. See Rule 5.6(c) (definition of ``Stop (Stop-Loss)''
order).
    \7\ A ``Stop-Limit'' order is an order to buy (sell) that
becomes a limit order when the consolidated last sale price
(excluding prices from complex order trades if outside the NBBO) or
NBB (NBO) for a particular option contract is equal to or above
(below) the stop price specified by the User. A User may not
designate a Stop-Limit Order as All Sessions. Users may not
designate bulk messages as Stop-Limit Orders. A User may not
designate a Stop-Limit order as Direct to PAR. See Rule 5.6(c)
(definition of ``Stop-Limit'' order).
---------------------------------------------------------------------------

    Drill-through price protection is currently described in Exchange
Rule 5.34(a)(4)(A). Rule 5.34(a)(4)(A) equates the drill-through
reference price for a buy (sell) order to a price up to a buffer amount
(the Exchange determines the buffer amount on a class and premium
basis) above (below) the offer (bid) limit of the Opening Collar or the
NBO (NBB) that existed at the time of order entry, respectively (the,
``drill-through price'').\8\
---------------------------------------------------------------------------

    \8\ See Rule 5.34(a)(4)(A).
---------------------------------------------------------------------------

    Currently, when multiple Stop (Stop-Loss) or Stop-Limit orders are
triggered by the same price, the System \9\ considers them separate
orders received in sequence and enters them sequentially into the
Book.\10\ As such, when determining the drill-through price for each
order, the System uses the contra side NBBO that existed at the time
each of the orders was entered into the Book.\11\ By applying drill-
through price protection in this manner, the Exchange has observed,
particularly in thinly traded markets, that the first order triggered
will trade with the best priced contra-side order, while the second
triggered order can trade at prices that may be multiple price levels
away, as it is using the NBBO that existed after the first triggered
order executed. Accordingly, the Exchange seeks to enhance the drill-
through price functionality as it relates to Stop (Stop-Loss) and Stop
Limit Orders, through the addition of proposed Rule 5.34(a)(4)(E).
Under proposed Rule 5.34(a)(4)(E), rather than using separate drill-
through prices for each individual Stop and Stop-Limit order, the
System will instead use the contra-side NBBO that existed at the time
the first order in sequence was entered into the Book as the drill-
through price, for all orders. This is the drill-through price that
would apply to each Stop or Stop-Limit order if it was the only one
triggered at that price. By way of illustration, consider the following
examples:
---------------------------------------------------------------------------

    \9\ ``System'' means the Exchange's hybrid trading platform that
integrates electronic and open outcry trading of option contracts on
the Exchange and includes any connectivity to the foregoing trading
platform that is administered by or on behalf of the Exchange, such
as a communications hub. See Rule 1.1. (definition of, ``System'').
    \10\ ``Book'' means the electronic book of simple orders and
quotes maintained by the System, which single book is used during
both the regular trading hours and global trading hours trading
sessions. See Rule 1.1 (definition of, ``Book'').
    \11\ See Rule 5.34(a)(4)(A).
---------------------------------------------------------------------------

    Example 1--Current Functionality
    Assume that the drill-through price buffer \12\ for a certain
option series is $0.25, and that the following quotes are in the Book:
Quote 1 (NBBO): 5.00 x 7.00; Quote 2: 4.00 x 8.00. Each quote has a
size of 1. Additionally, the following Stop-Loss/Stop Limit orders are
being held in the System when the Quote 1 offer is updated to $6.50
(they were received by the System in sequence):
---------------------------------------------------------------------------

    \12\ The Exchange determines the buffer amount on a premium and
class basis.

Order 1: Sell 1 @Market, Stop Price = $6.50
Order 2: Sell 1 @Market, Stop Price = $6.55
Order 3: Sell 1 @Market, Stop Price = $6.50

    Per current Rule 5.34(a)(4), the following will occur:

    1. Orders 1, 2 and 3 are held in the System, and handled as
separate orders received in sequence. Each have stop prices less than
the NBO, and are therefore triggered by the 6.50 quote, and enter the
Book for execution or posting. Under today's functionality, the System
assigns each order a separate drill-through price, equal to the contra-
side NBBO in existence at the time each order separately entered the
Book for execution.
    2. Order 1 will execute against Quote 1 @$5.00. Using the NBB of
$5.00 as the drill-through price, the System would prevent execution
beyond $4.75.
    3. When Order 1 executes against Quote 1 @5.00, that NBB will no
longer be in the Book. Instead Order 2 will execute against Quote 2
@4.00 and use the NBB of 4.00 as the drill-through price, and prevent
execution beyond $3.75.
    4. Order 3 will cancel due to no liquidity left at the drill-
through price of $3.75.
    Example 2--Proposed Functionality
    Again, assume that the drill-through price buffer for a certain
option series is $0.25, and that the following quotes are in the Book:
Quote 1 (NBBO): 5.00 x 7.00; Quote 2: 4.00 x 8.00. Each quote has a
size of 1. Additionally, the following Stop-Loss/Stop Limit orders are
being held in the System when Quote 1 offers is updated to $6.50 (they
were received by the System in sequence):

Order 1: Sell 1 @Market, Stop Price = $6.50
Order 2: Sell 1 @Market, Stop Price = $6.55
Order 3: Sell 1 @Market, Stop Price = $6.50

    Per proposed Rule 5.34(a)(4)(E), the following will occur:
    1. Orders 1, 2 and 3 each have stop prices less than the NBO, and
will therefore be triggered by the 6.50 quote, and enter the Book for
execution or posting. A drill-through price for all three orders is set
at the contra-side NBB of 5.00.
    2. Order 1 will execute against Quote 1 @$5.00.
    3. Orders 2 and 3 will cancel due to no liquidity left at the
drill-through price of $4.75.
    The Exchange notes that aside from the difference in drill-through
price, the drill-through mechanism will apply in the same manner to
these orders. The Exchange is not proposing wholly new drill-through
protection behavior, but rather only seeks to modify the reference
price utilized by the drill-through price protection for Stop (Stop-
Loss) and Stop Limit orders if multiple such orders are triggered and
entered into the Book for execution due to the same price event. By
using the same drill-through price for all triggered orders eligible
for execution, the proposed modification will help the drill-through
protection prevent

executions too far away from the NBBO when multiple Stop (Stop-Loss)
and Stop Limit orders become eligible for execution. In doing so, Stop
(Stop-Loss) and Stop Limit orders will receive executions at prices
more closely aligned to the stop prices specified by Exchange Users.
2. Statutory Basis
    The Exchange believes the proposed rule amendment is consistent
with the requirements of Section 6(b) of the Act,\13\ in general, and
Section 6(b)(5) of the Act,\14\ in particular, in that it is designed
to prevent fraudulent and manipulative acts and practices, to promote
just and equitable principles of trade, to foster cooperation and
coordination with persons engaged in facilitating transactions in
securities, to remove impediments to, and perfect the mechanism of, a
free and open market and a national market system and, in general, to
protect investors and the public interest.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Specifically, the Exchange believes that proposed Rule
5.34(a)(4)(E) does not unfairly discriminate amongst Users. Under
proposed Rule 5.34(a)(4)(E), all Users with Stop (Stop-Loss) and Stop-
Limit Orders triggered by the same price event will have the same
drill-through reference price. The primary purpose of the drill-through
price protection is to prevent orders from executing at prices ``too
far away'' from the market when they enter the Book for potential
execution. The Exchange believes the proposed rule change is consistent
with this purpose, and thus will promote just and equitable principles
of trade and protect investors, because Users who submit Stop and Stop-
Limit Orders will receive the same level of drill-through price
protection against execution at potentially erroneous prices,
regardless of the sequence in which they enter the Book. As a result of
the proposed rule change, all Users' Stop and Stop-Limit Orders will
receive protection based on the NBBO at the time those orders were
triggered to enter the Book for potential execution, which is
consistent with the drill-through protection as well as Stop Order
functionality.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change imposes
any burden on intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. Under the
current drill-through price protection functionality, the System's use
of separate drill-through prices can result in Stop Orders executed
later in sequence being filled at prices several levels away from the
NBBO in existence at the time they are triggered and entered into the
Book for execution merely because those orders were submitted after
another Stop Order. As discussed above, the proposed rule change will
apply the same drill-through price (and thus the same level of drill-
through price protection) to Stop and Stop-Limit Orders that become
eligible for potential execution at the same time due to the same price
triggering event.
    The Exchange does not believe that the proposed rule change will
impose any burden on intermarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act because it
relates solely to how an Exchange price protection applies to Stop
(Stop-Loss) and Stop Limit orders. The proposed enhancement to the
drill-through protection is consistent with the current protection and
provides orders subject to drill-through price protection with improved
protection against execution at potentially erroneous prices.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposal. No written comments were solicited or
received on the proposed rule change.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to Section 19(b)(3)(A) of the Act \15\ and Rule 19b-4(f)(6)
\16\ thereunder.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    The Exchange has asked the Commission to waive the 30-day operative
delay such that Exchange Users will be able to more quickly benefit
from the proposed Drill through protections that are designed to: (1)
Prevent potentially erroneous executions and (2) more closely align the
execution prices of Stop Orders and Stop Limit Orders that become
eligible for potential execution at the same time due to the same price
triggering event.\17\ The Commission finds that waiving the 30-day
operative delay is consistent with the protection of investors and the
public interest. Specifically, waiver of the operative delay should
allow Exchange Users to utilize Stop Orders and Stop Limit Orders with
an increased likelihood that the execution price of such orders will be
more closely related to the market at the time the order is triggered
for entry onto the C2 Book. Accordingly, the Commission designates the
proposal operative upon filing.\18\
---------------------------------------------------------------------------

    \17\ 17 CFR 240.19b-4(f)(6)(iii).
    \18\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule change's impact on
efficiency, competition, and capital formation. 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-C2-2022-005 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-C2-2022-005. This file
number should be included on the subject line if email is used. To help
the Commission process and review your

comments more efficiently, please use only one method. The Commission
will post all comments on the Commission's internet website (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent
amendments, all written statements with respect to the proposed rule
change that are filed with the Commission, and all written
communications relating to the proposed rule change between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for website viewing and printing in the Commission's Public
Reference Room, 100 F Street NE, Washington, DC 20549 on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
the filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-C2-2022-005 and should be submitted on or before March
25, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-04562 Filed 3-3-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Notices]
[Pages 54597-54598]
[FR Doc No: 2018-23637]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3759]

Considerations for the Development of Dried Plasma Products
Intended for Transfusion; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft document entitled ``Considerations for the
Development of Dried Plasma Products Intended for Transfusion; Draft
Guidance for Industry.'' This guidance is intended to assist
manufacturers, sponsors, and applicants developing dried plasma
products intended for transfusion in order to facilitate the
availability of safe and effective dried plasma products in the United
States. The draft guidance document provides considerations for the
successful development and licensing of dried plasma products and for
the approval of devices used to manufacture dried plasma. The guidance
includes recommendations on optimal sources of input plasma;
manufacturing and product quality, including product characterization;
packaging and reconstitution; clinical studies; and device submissions.

DATES: Submit either electronic or written comments on the draft
guidance by January 28, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2018-D-3759 for ``Considerations for the Development of Dried
Plasma Intended for Transfusion; Draft Guidance for Industry.''
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 the draft guidance to
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.

FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled
``Considerations for the Development of Dried Plasma Products Intended
for Transfusion; Draft Guidance for Industry.'' Plasma is a critical
component of early transfusion therapy in the management of traumatic
hemorrhage. Plasma can replenish various coagulation proteins that are
consumed during the coagulopathy that can accompany traumatic injury.
Because plasma products intended for transfusion such as fresh frozen
plasma (FFP), plasma frozen within 24 hours after phlebotomy (PF24),
and plasma frozen within 24 hours after phlebotomy held at room
temperature up to 24 hours after phlebotomy (PF24, RT24) are stored
frozen, these products need to be thawed prior to transfusion. This
limits

or prevents the use of plasma in settings where freezers and other
support equipment are unavailable (e.g. battlefields, remote locations,
and other austere settings) and may lead to delayed administration.
Dried plasma (such as freeze-dried or spray-dried plasma) offers the
potential to address these challenges by providing a product that is
stable at ambient temperatures and can be rapidly reconstituted and
transfused.
    Recent clinical studies have demonstrated promising efficacy and
safety of dried plasma, particularly in military applications, and
dried plasma products are available for limited use in Germany, South
Africa, and France. This guidance is intended to assist manufacturers,
sponsors, and applicants developing dried plasma products intended for
transfusion in order to facilitate the availability of safe and
effective dried plasma products in the United States.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on considerations
for the development of dried plasma products intended for transfusion.
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 draft guidance refers to previously approved collections of
information 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 211 have been approved
under OMB control number 0910-0139; 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 601 have been approved
under OMB control number 0910-0338; the collections of information in
21 CFR part 610 have been approved under OMB control numbers 0910-0116,
0910-0139, and 0910-0338; the collections of information in 21 CFR part
630 have been approved under OMB control number 0910-0116; the
collections of information in 21 CFR part 640 have been approved under
OMB control number 0910-0116; the collections of information in 21 CFR
part 812 have been approved under OMB control number 0910-0078; and the
collections of information in 21 CFR part 814 have been approved under
OMB control number 0910-0231.

III. Electronic Access

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

    Dated: October 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23637 Filed 10-29-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: November 17, 2009 (Volume 74, Number 220)]
[Notices]
[Page 59157-59158]
[DOCID:fr17no09-44]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL10-12-000]

Commonwealth Edison Company; Commonwealth Edison Company of
Indiana, Inc.; Notice of Filing

November 9, 2009.
    Take notice that on November 3, 2009, pursuant to Rule 207 of the
Federal Energy Regulatory Commission's Rules of Practice and Procedure,
18 CFR 385.207 (2008), Commonwealth Edison Company, on behalf of itself
and its wholly-owned subsidiary, Commonwealth Edison Company of
Indiana, Inc., filed a Petition for Declaratory Order requiring the
Midwest Independent Transmission System Operator to recognize the
assignment of Section 4.8 transmission credits and allow the Ameren
Entities to take service under Schedule 10-A of the MISO Open Access
Transmission Tariff until earlier of the date they exhaust the
purchased credits or December 15, 2013.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as

appropriate. Such notices, motions, or protests must be filed on or
before the comment date. On or before the comment date, it is not
necessary to serve motions to intervene or protests on persons other
than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on November 24, 2009.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-27479 Filed 11-16-09; 8:45 am]

BILLING CODE 6717-01-P