[Federal Register: June 4, 2007 (Volume 72, Number 106)]
[Proposed Rules]
[Page 30729-30734]
[DOCID:fr04jn07-8]

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Proposed Rules
                                                Federal Register
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This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1910

[Docket No. OSHA-2007-0003]
RIN 1218-AC22

Power Presses

AGENCY: Occupational Safety and Health Administration (OSHA), DOL.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: Mechanical power press safety is regulated under OSHA's
mechanical power presses standard. OSHA adopted the standard in 1971,
basing it upon the 1971 edition of American National Standards
Institute (ANSI) B11.1, the industry consensus standard for mechanical
power presses. This ANSI standard has been updated a number of times
since OSHA adopted the 1971 version. The most recent edition was issued
in 2001. Hydraulic and pneumatic power presses are not covered by
OSHA's current standard. The original standard also did not address the
use of presence-sensing-device initiation (PSDI) systems. When a press
is equipped with PSDI, the press cycle will not initiate until the PSDI
system senses that the danger zone is clear. OSHA updated the
mechanical power presses standard on March 14, 1988, (53 FR 8353), to
permit the use of PSDI systems. However, it requires an OSHA-approved
third party to validate the PSDI system at installation and annually
thereafter. Since the adoption of this provision, no third party has
sought OSHA's approval. Consequently, PSDI systems are not being used
with mechanical power presses. OSHA is seeking comments on whether and
how the mechanical power presses standard should be amended, including
whether the requirements pertaining to the use of PSDI systems should
be revised and whether the scope of the standard should be expanded to
cover other types of presses.

DATES: Comments must be submitted by the following dates:
     Hard copy: Submit (postmark or send) comments by regular
mail, express delivery, hand delivery, and courier service by August 3,
2007.
     Electronic transmission and facsimile: Submit comments by
August 3, 2007.

ADDRESSES: You may submit comments by any of the following methods:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal

eRulemaking Portal. Follow the instructions on-line for submitting
comments.
    Fax: If your comments, including attachments, are not longer than
10 pages, you may fax them to the OSHA Docket Office at<PHONE_NUMBER>.
    Mail, hand delivery, express mail, messenger or courier service:
You must submit three copies of your comments and attachments to the
OSHA Docket Office, Docket No. OSHA-2007-0003, U.S. Department of
Labor, Room N-2625, 200 Constitution Avenue, NW., Washington, DC 20210.
Deliveries (hand, express mail, messenger and courier service) are
accepted during the Department of Labor's and Docket Office's normal
business hours, 8:15 a.m.-4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and the
OSHA docket number for this rulemaking (OSHA Docket No. OSHA-2007-
0003). All comments, including any personal information you provide,
are placed in the public docket without change and may be made
available online at http://www.regulations.gov. For further information

on submitting comments, plus additional information on the rulemaking
process, see the ``Public Participation'' heading in the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at

the address above. All documents in the docket are listed in the http://www.regulations.gov
 index, however, some information (e.g.,

copyrighted material) is not publicly available to read or download
through the Web site. All submissions, including copyrighted material,
are available for inspection and copying at the OSHA Docket Office.

FOR FURTHER INFORMATION CONTACT:
    Press Inquiries: Kevin Ropp, OSHA Office of Communications, Room N-
3647, U.S. Department of Labor, 200 Constitution Avenue, NW.,
Washington, DC 20210; telephone:<PHONE_NUMBER>.
    General and Technical Information: David M. Wallis, OSHA
Directorate of Standards and Guidance, Office of Engineering Safety,
Room N-3609, U.S. Department of Labor, 200 Constitution Avenue, NW.,
Washington, DC 20210; telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
    A. OSHA's Existing Mechanical Power Presses Standard
    B. OSHA's Section 610 Review of the PSDI Requirements
II. Request for Data, Information, and Comments
    A. The Scope of the Power Press Standard
    B. Consensus Standards Related to Mechanical Power Presses
    C. Technical Issues
    D. Cost Issues
    E. Training Requirements
    F. Reporting and Recordkeeping Requirements
III. Public Participation
IV. Authority and Signature

I. Background

A. OSHA's Existing Mechanical Power Presses Standard

    OSHA promulgated Sec.  1910.217, the standard for mechanical power
presses, in 1971. The standard was based on the 1971 edition of
American National Standards Institute (ANSI) B11.1, the industry
consensus standard on mechanical power presses. See 39 FR 23732 (June
27, 1974). Hydraulic and pneumatic power presses are not covered by the
standard. See Sec.  1910.217(a)(5).
    A mechanical power press is a two-part system, with a stationary
bed or anvil and a movable upper part, the ram. A die or punch is
placed on the ram and the ram descends into a die block, which is
attached to the anvil. The punch and die block are known as the die
set. A mechanical power press can be either full revolution or part
revolution. A full-revolution press cannot be stopped once the cycle
begins. A part-revolution press has a brake that can stop the press in
mid

cycle. Mechanical power presses are used in a number of industries,
including fabricated metal, industrial machinery, and transportation
vehicle parts. These industries all require metal parts, which are
formed in presses, to create finished products.
    If employees are not clear of power presses when their cycles are
initiated, serious injuries can occur. The mechanical power presses
standard contains numerous provisions for protecting employees who work
with and around the presses. In particular, the standard contains
requirements for safeguarding the ``point of operation'' of the press,
the area of the press between the punches and the die block. These
requirements help ensure that employees are clear of this ``danger
zone'' when the press is in operation. The standard requires employers
to ensure ``the usage of `point of operation guards' or properly
applied and adjusted point of operation devices on every operation
performed on a mechanical power press.'' See Sec.  1910.217(c)(1)(i).
    Point of operation guards on mechanical power presses prevent entry
of hands or fingers into the point of operation. Under the standard,
employers can utilize a number of different types of guard systems: die
enclosure guards, fixed barrier guards, interlock press barrier guards,
and adjustable barrier guards. See Sec.  1910.217(c)(2). Point of
operation devices, on the other hand, are systems that protect
employees by preventing or stopping the press cycle when hands or other
objects are inadvertently placed in the point of operation. Examples of
point of operation devices are Type A gates \1\ or movable barrier
devices, or Type B gates \2\ or movable barrier devices, and presence-
sensing devices. See Sec.  1910.217(c)(3). A presence-sensing device is
basically a light curtain or other sensing device that prevents or
stops the slide motion of the press if the operator's hand or other
part of the body is within the sensing field of the device during the
downstroke of the press slide.
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    \1\ A Type A gate is a movable barrier device designed to be
held in position during the entire press cycle (stroke) so that the
operator cannot easily open the movable barrier during the cycle. It
is designed to prevent reentry into the point of operation in the
event of a failure of the press or its related control equipment
when there may be a repeat cycle of the press.
    \2\ A Type B gate is a movable barrier device designed for use
on part-revolution presses so that it is held closed during the
closing portion of the cycle (stroke).
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    Point of operation devices also include certain systems that limit
how a press cycle may be initiated. For example, the standard allows
for two-hand initiation devices. See Sec.  1910.217(c)(3)(e). The two-
hand devices require the operator to press two buttons simultaneously
in order to initiate the press cycle; the buttons must be far enough
apart that they cannot be pressed with one hand. In addition, the
controls must be a certain distance from the point of operation so that
the controller cannot enter the danger zone after activating the press.
While the two-hand controls help protect the employees operating the
presses, they can be uncomfortable, may increase worker fatigue, and
can increase the time between press cycles.
    The existing standard also includes requirements for inspecting,
maintaining, and modifying mechanical power presses to ensure that they
are operating safely. See Sec.  1910.217(e). It requires operators and
maintenance personnel to be trained in how to use or inspect power
presses safely. See Sec.  1910.217(e)(3) and (f)(2). And, it includes
provisions for power press operation to ensure that there is sufficient
clearance around the machines for them to operate safely, among other
things. See Sec.  1910.217(f)(4). These provisions, along with the
point of operation protections above, work to protect employees working
with and around mechanical power presses.
    In 1988, OSHA added paragraph (h) to Sec.  1910.217 to allow the
use of presence-sensing-device initiation on part-revolution mechanical
power presses. PSDI systems initiate press cycles when the systems
indicate that no objects are within the danger zone. These systems
differ from presence sensing point of operation devices in that these
systems initiate the press cycles; presence sensing point of operation
devices, as stated above, stop or prevent the cycles from occurring if
an operator's hand or other body parts are in the danger zone. PSDI
systems had been used on mechanical power presses in Europe for decades
and on an experimental basis for a 1-year period beginning on August
31, 1976, at one United States facility under a temporary variance
(Interlake Stamping Corporation (41 FR 36702)). PSDI systems were also
used on non-mechanical power presses and other types of equipment.
    When paragraph (h) was added in 1988, OSHA imposed a number of
requirements for the use of PSDI systems based upon its analysis of the
rulemaking record, which included comments from industry, union, and
academic experts. See 53 FR 8322 (March 14, 1988). OSHA required that
every PSDI system be initially validated by an OSHA-certified third
party and re-validated by a certified third party annually. See Sec.
1910.217(h)(11). The third-party validation was based on existing
systems in Sweden and Germany, where the government certified this type
of equipment. OSHA believed that national testing laboratories and
industry organizations would conduct the third-party validation.
    In its 1988 rulemaking, OSHA analyzed the impact of paragraph (h)
on employers as part of its economic impact analysis. At that time,
OSHA estimated that approximately 73,000 employees would be affected by
the requirements. These employees are primarily punch and stamping
press operators and job and die setters. OSHA estimated that 40 percent
of the former group and 20 percent of the latter were operating
mechanical power presses. OSHA estimated that PSDI would increase
productivity an average of 24.3 percent per press, resulting in
industry savings of about $162 million a year. See 53 FR 8351 (March
14, 1988). OSHA also believed, and continues to believe, that
mechanical power presses equipped with PSDI, if properly designed,
installed, and used, could reduce the likelihood of accidents.

B. OSHA's Section 610 Review of the PSDI Requirements

    OSHA is required by Section 610 of the Regulatory Flexibility Act
(5 U.S.C. 610) and Executive Order 12866 to conduct periodic reviews of
rules (``Section 610 Reviews''). The purpose of these reviews is to
determine whether such rules should be continued without change,
amended, or rescinded, consistent with the objectives of applicable
statutes, to minimize any significant economic impact of the rules on a
substantial number of small entities. In doing so, the agency takes
into consideration the continued need for the rule, comments and
complaints received regarding the rule, the complexity of the rule,
whether the rule is duplicative, and changes in technology and economic
conditions since the issuance of the rule. The reviews also examine
whether the rules are compatible with other regulations, duplicative or
inappropriately burdensome in the aggregate, and whether and how they
could be made more effective.
    OSHA conducted a Section 610 review to determine why PSDI has not
been implemented, and to identify how the standard could be changed to
facilitate PSDI use in a manner that protects worker safety. In its
August 28, 2002, Federal Register notice (67 FR 55181) informing the
public about the

review and soliciting comments, OSHA presented four options for
revising the standard:
    Option 1--Update all of Sec.  1910.217 to be consistent with ANSI
B11.1-2001 or something similar.
    Option 2--Revise the third-party validation requirements.
    Option 3--Eliminate all requirements for third-party validation and
possibly replace them with a self-certification requirement; leave the
other PSDI requirements intact.
    Option 4--Replace OSHA's current PSDI requirements with the PSDI
requirements in the new ANSI B11.1.
    The Agency published its final report on the review in May 2004 and
notified the public of its availability on June 8, 2004 (69 FR 31927).
The review includes information on the main industry categories using
mechanical power presses and estimates of injury trends. The review
states that there were 194,891 presses of all types in use in 1996.
Mechanical power presses are used mainly in the following manufacturing
industry categories: fabricated metal, industrial machinery, electrical
machinery, transportation vehicle parts, and precision instruments. The
review also included information about injuries caused by mechanical
power presses. It found that there were 774 mechanical power press
accidents reported to OSHA from 1995-2000 under 29 CFR 1910.217(g),
which requires employers to report to OSHA all point of operation
injuries. It also cited BLS data that approximately 6,000 injuries per
year occurred on nonprinting presses (including mechanical power
presses and other types of presses) from 1992 to 1999.
    Based on analyses and information obtained during the Section 610
review, OSHA committed to pursuing Option 1, to update all of Sec.
1910.217 to be consistent with ANSI B11.1-2001 or something similar
[Ex. OSHA-2007-0003-0002]. Option 1 addressed concerns that the
mechanical power presses standard as a whole is out-of-date and could
be made safer. While PSDI system technology has not changed since
paragraph (h) was adopted in 1988, the technology used to control and
guard mechanical power presses has changed considerably since Sec.
1910.217 was adopted. For instance, some mechanical power presses now
use operational modes not addressed in Sec.  1910.217 (such as computer
controls), which introduce hazards also not addressed by the standard.
Five of the nine commenters who responded to OSHA's August 28, 2002,
Federal Register notice recommended that OSHA replace the entire
mechanical power press standard with ANSI B11.1-2001. They argued that
PSDI is an integral part of that ANSI standard, which has no validation
requirement. Furthermore, they argued that an update is overdue, would
create a range of benefits, and would lead to implementation of PSDI
[Ex. OSHA-2007-0003-0002]. OSHA agrees with these commenters and
believes that such an update would result in improved safety and health
protections for operators of mechanical power presses as well as for
other employees in the machine area.

II. Request for Data, Information, and Comments

    The Agency is considering a broad range of issues in its
development of a proposed update to the mechanical power presses
standard. The issues to be considered go beyond those of the current
mechanical power presses standard and include broadening the scope of
the standard to include other types of presses, equipment, and
processes not previously addressed.
    OSHA invites comments on the questions below. The questions are
grouped into six broad categories: The scope of the standard; industry
consensus standards related to mechanical power presses; technical
issues; training requirements; reporting requirements; and employer
responsibilities. However, commenters are encouraged to address any
aspect of power presses, including pneumatic, hydraulic, and other
presses, which would assist the Agency in its consideration of what
action is appropriate. The Agency is particularly interested in ways to
incorporate flexibility into its standard to make it more protective as
well as easier to comply with. Please provide a detailed response to
the questions, as well as any supporting information or data, to better
assist the Agency in its consideration of these matters.

A. The Scope of the Power Press Standard

    1. As stated above, the current OSHA standard covers only
mechanical power presses. OSHA is considering changing the scope of the
standard to include other types of power presses, such as hydraulic
presses and pneumatic presses. Do the existing general machine guarding
requirements in Sec.  1910.212 adequately protect employees operating
non-mechanical power presses, and do they provide adequate flexibility
to employers who use such presses? Should OSHA regulate all power
presses under one standard or under multiple standards? Should OSHA
address non-mechanical power presses in this rulemaking action to
update Sec.  1910.217? Are there general requirements that should apply
broadly to all types of power presses?
    2. If OSHA does broaden the scope of the standard to include other
types of presses, what other types of power presses should OSHA
specifically include? Why?
    3. The current OSHA standard specifically excludes press brakes,
hydraulic and pneumatic power presses, bulldozers, hot bending and hot
metal presses, forging presses and hammers, riveting machines, and
similar types of fastener applicators. The ANSI B11.1-2001 standard
excludes these as well; however, it also excludes cold headers and
formers, eyelet machines, high-energy-rate presses, iron workers and
detail punches, metal shears, powdered metal presses, press welders,
turret and plate-punching machines, wire termination machines, and
welding machines. If OSHA updates the standard to be consistent with
the provisions of ANSI B11.1-2001 or its equivalent, should OSHA
exclude all of the machines that are excluded in ANSI B11.1-2001? Why?
Should OSHA exclude any other machines that are not specifically
excluded in ANSI B11.1-2001? Why?
    4. Since it has been more than 30 years since OSHA's adoption of
its mechanical power press standard, OSHA realizes that changes in
technology may have affected the way industry sectors operate. Are
there mechanical power presses in use today that--due to their unique
characteristics--are not covered by OSHA's current standard? Please
supply OSHA with information about these presses. Does the current
standard cover any equipment that is no longer in use? Would adoption
of ANSI B11.1-2001 or something similar render equipment currently in
use obsolete? Is there equipment that is currently in use that should
be grandfathered into a revised OSHA standard that would otherwise
restrict the use of such equipment? Why?

B. Consensus Standards Related to Mechanical Power Presses

    5. As stated above, OSHA intends to update the mechanical power
press standard to be consistent with ANSI B11.1-2001 or something
similar. Are there any obstacles to complying with a new standard that
is based on ANSI B11.1-2001 or its equivalent?
    6. Are there provisions in the current ANSI standard that should
not be the basis for provisions in the revised OSHA standard? Should
OSHA include

any provisions that are not covered by the ANSI standard? If so, what
are the provisions?
    7. Should the Agency include information from the appendices or the
explanatory information columns contained in the ANSI B11.1 standard in
the revised OSHA standard? If so, what information in particular should
OSHA consider?
    8. Are there other consensus standards, international standards, or
other references OSHA should consider in updating its mechanical power
presses standard? If so, which ones should OSHA consider in drafting a
proposed rule?
    9. Some of the technical definitions and requirements in the ANSI
standard, including those for the reliability and classes of control
systems, are not contained within the standard itself but are instead
found in technical reports to the ANSI B11.1 committee. Should these
reports serve as one of the bases for a revised OSHA standard? If so,
what specific information from these reports should OSHA consider?

C. Technical Issues

    10. During the Section 610 review, OSHA found that there has been
some decline in mechanical power press use in the United States in the
last 20 years. Please provide any information you have on current
mechanical power press use.
    11. Are there other developments in the use of mechanical power
presses that are relevant for OSHA's development of a proposal? For
example, the Section 610 review indicated that computer-controlled
presses are increasingly common. How has the increased use of computer-
controlled presses--as well as other technological developments--
affected safety and productivity in the workplace?
    12. The current OSHA standard permits any person to reconstruct or
modify a mechanical power press as long as the reconstruction or
modification is performed in accordance with Sec.  1910.217(b). The
ANSI B11.1-2001 standard permits only suppliers to reconstruct or
modify a mechanical power press, as in ANSI B11.1-2001 paragraphs 4.1
through 4.1.3 [Ex. OSHA-2007-0003-0003]. Should OSHA similarly limit
press reconstruction and modification to the supplier of the equipment?
Why? Should a revised OSHA standard address the qualifications of
persons who reconstruct or modify mechanical power press equipment?
    13. OSHA's current standard requires third-party validation for
PSDI such that a single failure or single operating error may not cause
injury to personnel from a point-of-operation hazard. Appendix A,
Certification/Validation Requirements. Should OSHA retain some form of
third-party validation, but remove this aspect of the validation
criteria?
    14. If the Agency does not require third-party validation, would
the certification requirements found in the following paragraphs be
necessary: Sec.  1910.217(h)(5)(i) (adjusting brake monitoring during
installation certification); (h)(9)(ii)(B) (certification of
alternatives to photo-electric light curtains); and (h)(11)(i)(B),
(h)(11)(ii), (h)(11)(iii), (h)(11)(v) (safety system certification/
validation)? Why or why not?
    15. OSHA's current PSDI provisions include requirements for brakes
and clutches that are not found in the ANSI B11.1-2001 standard. See
Sec.  1910.217(h)(2). Should OSHA retain these or similar requirements
in a revised standard? Why? Should OSHA remove the provisions entirely?
Why? Would removing these provisions adversely impact employee safety
or are these provisions unnecessary given the PSDI systems currently
available?
    16. OSHA's current PSDI standard includes provisions for flywheels
and bearings that are not included in the ANSI B11.1-2001 standard. See
Sec.  1910.217(h)(4). Should OSHA retain these requirements or
something similar? Why? Would removing these provisions adversely
impact employee safety or are these provisions unnecessary given the
PSDI systems currently available?
    17. OSHA currently limits PSDI systems to normal production
operations (and not die-setting or maintenance procedures). See Sec.
1910.217(h)(1)(v). Should OSHA continue this limitation? Why?
    18. Are there any guarding methods or safety equipment in use today
not covered by OSHA's current standard? Please supply OSHA with
information about them. Does the current standard cover any guarding
method or safety equipment no longer in use?
    19. Are there any guarding methods or safety equipment in use today
that the current ANSI standard does not address? Does the current ANSI
standard cover any guarding method or safety equipment no longer in
use?
    20. OSHA's current standard has no specific provisions covering
computer-controlled mechanical power presses. To what extent are
employers using computer-controlled mechanical power presses? Are these
types of presses becoming more common? What procedures, guarding
methods, and safety considerations are used when using these types of
presses? Are there any special hazards or concerns when using computer-
controlled mechanical power presses of which the Agency should be
aware?
    21. OSHA's current mechanical power press standard has no specific
provisions covering servo-actuated presses. To what extent are
employers using servo-actuated presses? Are these types of presses
becoming more common? What procedures, guarding methods, and safety
considerations are used when using these types of presses? Are there
any special hazards or concerns when using servo-actuated presses of
which the Agency should be aware?

D. Cost Issues

    22. What has been the experience of PSDI systems on mechanical
power presses and other machines internationally, particularly in
Europe? What additional costs have been involved in integrating them
into manufacturing operations? What have been the benefits in terms of
safety and productivity?
    23. What has been the experience of PSDI systems with regard to
other types of machines in the United States (i.e., those not covered
by the mechanical power press rule)?
    24. Are there estimates of the cost savings of using PSDI systems
more widely? Are there mechanical power presses where PSDI would
provide few or no cost savings?
    25. OSHA's Section 610 review of the mechanical power press rule
indicated that in many cases mechanical power presses are being
replaced with hydraulic presses. How widespread is this trend and what
are the reasons for it? How much of this is related to underlying
technological and economic trends?

E. Training Requirements

    26. OSHA's current standard at Sec.  1910.217(f) requires employers
to train employees on safe methods of work. However, the standard does
not spell out specific training or retraining requirements. Should OSHA
change its existing performance-oriented approach with specific
training and retraining provisions? Why?
    27. The ANSI B11.1-2001 standard includes more detailed training
requirements than the OSHA standard [Ex. OSHA-2007-0003-0003]. Should
OSHA adopt ANSI's approach to training? Why?
    28. Are there any training or retraining requirements that are not

found in the OSHA or ANSI standards that OSHA should include in the
updated standard? If so, what are they and why should OSHA include
them? Are there any training or retraining requirements that are found
in the ANSI standard that OSHA should not include in the updated
standard? If so, what are they and why should OSHA not include them in
the updated standard?
    29. OSHA's current standard does not specify how often training
should occur. Should OSHA specifically require annual or semiannual
training? Should retraining only be required when employees are
observed improperly operating equipment, or are there other times when
employees should be retrained?
    30. When OSHA adopted the PSDI provisions, it also added specific
training requirements for employers using PSDI systems. See Sec.
1910.217(h)(13). Are those requirements sufficient to ensure operators
are effectively trained in PSDI operation? Should OSHA expand or reduce
the training requirements for PSDI systems?
    31. The current standard requires at Sec.  1910.217(h)(13)(ii) that
employers certify employee training for PSDI. Should OSHA retain this
requirement, or require other training documentation? Why or why not?

F. Reporting and Recordkeeping Requirements

    32. The current standard requires at Sec.  1910.217(h)(9)(ii)(B)
that employers notify OSHA 3 months before the operation of any
alternative system to photo-electric light curtains. The notification
must include ``the name of the system to be installed, the manufacturer
and the OSHA-recognized third-party validation organization
immediately.'' Should OSHA retain this requirement or a similar
requirement in a revised standard?
    33. Paragraph Sec.  1910.217(g) requires employers to report to
OSHA within 30 days any point of operation injury to operators or other
employees. Do employers also use this information for their own
purposes? If so, how? Should OSHA eliminate this requirement? Why or
why not?
    34. Under paragraph (e)(1)(i), employers must maintain a
certification record of periodic and regular inspections of power
presses. This certification must contain: The date of the inspection;
the signature of the person who performed the inspection; and the
serial number or other identifier of the power press inspected.
Similarly, paragraph (e)(2)(ii) requires employers to maintain a record
of required inspections, tests, and maintenance on the clutch/brake
mechanism, antirepeat feature and single stroke mechanism; these
inspections and tests must occur at least once a week. As with the
certification required by paragraph (e)(1)(i), the record must contain:
The date of the inspection, test or maintenance; the signature of the
person performing the inspection, test, or maintenance; and the serial
number or other identifier of the press. Should OSHA include these
requirements in a revised standard? Why? Should OSHA require employers
to maintain any additional information in the records, such as the
types of repairs made, or is there information that should not be
specifically required? Is a signature of the person performing the
inspection, test, or maintenance necessary or would the name suffice
for the record?
    35. Currently, ANSI B11.1-2001 specifies that an inspection program
be established with ``regular'' inspection of presses, but does not
specify the time frames for such inspections [Ex. OSHA-2007-0003-0003].
Also, ANSI B11.1-2001 does not specify what information employers
should maintain in inspection records [Ex. OSHA-2007-0003-0003]. Should
OSHA adopt ANSI's performance-oriented approach in a revised standard?
Why? If OSHA were to adopt provisions similar to the ANSI provisions,
how could the Agency determine whether an employer's inspections were
conducted at a reasonable frequency?
    36. OSHA's current standard specifies that each employer inspect
and test each press at least once a week to determine the condition of
the clutch/brake mechanism, antirepeat feature and single stroke
mechanism. Should OSHA expand or reduce the time interval between these
inspections and tests? Should any other elements be inspected or tested
this frequently? Do any of these elements need less frequent inspection
or testing?
    37. ANSI B11.1-2001 permits users to determine the content of
inspections and testing [Ex. OSHA-2007-0003-0003]. Should OSHA adopt
this type of performance-based approach in the revised standard? How
would OSHA enforce such a requirement? Would adopting ANSI's approach
lead to more press failures? Why?

III. Public Participation

Submission of Comments and Access to Docket

    You may submit comments in response to this document (1)
electronically at http://www.regulations.gov, which is the Federal

eRulemaking Portal; (2) by facsimile (FAX); or (3) by hard copy. All
comments, attachments and other material must identify the Agency name
and the OSHA docket number for this rulemaking (OSHA Docket No. OSHA-
2007-0003). You may supplement electronic submissions by uploading
document files electronically. If, instead, you wish to mail additional
materials in reference to an electronic or fax submission, you must
submit three copies to the OSHA Docket Office (see ADDRESSES section).
The additional materials must clearly identify your electronic comments
by name, date, and docket number so OSHA can attach them to your
comments.
    Because of security-related procedures, the use of regular mail may
cause a significant delay in the receipt of comments. For information
about security procedures concerning the delivery of materials by hand,
express delivery, messenger or courier service, please contact the OSHA
Docket Office at<PHONE_NUMBER> (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://www.regulations.gov.
 Therefore, OSHA cautions commenters about

submitting personal information such as social security numbers and
date of birth. Although all submissions are listed in the http://www.regulations.gov
 index, some information (e.g., copyrighted

material) is not publicly available to read or download through http://www.regulations.gov.
 All submissions, including copyrighted material,

are available for inspection and copying at the OSHA Docket Office.
Information on using the http://www.regulations.gov Web site to submit

comments and access the docket is available at the Web site's User Tips
link. Contact the OSHA Docket Office for information about materials
not available through the Web site and for assistance in using the
internet to locate docket submissions.
    Electronic copies of this Federal Register document are available
at http://www.regulations.gov. This document, as well as news releases

and other relevant information, also are available at OSHA's Web page
at http://www.osha.gov.

IV. Authority and Signature

    This document was prepared under the direction of Edwin G. Foulke,
Jr., Assistant Secretary of Labor for Occupational Safety and Health,
200 Constitution Avenue, NW., Washington, DC 20210. This action is
taken pursuant to sections 4, 6, and 8 of the Occupational Safety and
Health Act of 1970 (29 U.S.C. 653, 655, 657), Secretary

of Labor's Order No. 5-2002 (67 FR 65008), and 29 CFR part 1911.

    Signed at Washington, DC, this 29th day of May 2007.
Edwin G. Foulke, Jr.,
Assistant Secretary of Labor.
 [FR Doc. E7-10655 Filed 6-1-07; 8:45 am]

BILLING CODE 4510-26-P


Meeting with Foam Supplies, Inc. November 5, 2003 Participants Foam Supplies: Tim Kalinowski EPA: Anhar Karimjee, Suzie Kocchi This meeting was requested by Foam Supplies to provide EPA an update on their product, Ecomate, and to discuss transition from HCFC 141b to alternatives in the foam industry. Foam Supplies met with EPA to discuss the status of the transition post HCFC 141b production phaseout Foam Supplies noted the successful performance and results from Ecomate. Also, Foam Supplies noted that the industry would likely not complete the transition to alternatives as long as HCFC 141b was available either in stockpiles or coming in via the import of blended systems from Mexico.

EPA informed Foam Supplies it is considering ways to address the import of blended systems containing HCFC 141b from Mexico, including finalizing the 2000 proposed ban on the use of HCFC 141b in all foam blowing applications.


The link brings you to:
Electric Power Monthly Data for November 2022
Release Date: January 25, 2023
Next Release Date: February 27, 2023

I clicked down to

Table 5.6.A. Average Price of Electricity to Ultimate Customers by End-Use Sector, by State, November 2022 and 2021 (Cents per Kilowatthour)

U.S. Total  - Nov 2022

Residential:             15.64 cents per kilowatthours à 0.1564 $/kW-hr
Commercial:           12.50 cents per kilowatthours à 0.1250 $/kW-hr
Industrial:                 8.30 cents per kilowatthours à 0.0830 $/kW-hr
Transportation:        11.53 cents per kilowatthours à 0.1153 $/kW-hr
All Sectors:             12.46 cents per kilowatthours à 0.1246 $/kW-hr

update the electricity to 0.830 $/kW-hr


[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30953-30955]
[FR Doc No: 2021-12197]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2217]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; New Animal Drugs for
Investigational Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by July 12, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0117. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

New Animal Drugs for Investigational Use--21 CFR Part 511

OMB Control Number 0910-0117--Extension

    FDA has the authority under the Federal Food, Drug, and Cosmetic
Act (FD&C Act) to approve new animal drugs. A new animal drug
application (NADA) cannot be approved until, among other things, the
new animal drug has been demonstrated to be safe and effective for its
intended use(s). To properly test a new animal drug for an

intended use, appropriate scientific investigations must be conducted.
Under specific circumstances, section 512(j) of the FD&C Act (21 U.S.C.
360b(j)) permits the use of an investigational new animal drug to
generate data to support a NADA approval. Section 512(j) of the FD&C
Act authorizes us to issue regulations relating to the investigational
use of new animal drugs.
    Our regulations in part 511 (21 CFR part 511) set forth the
conditions for investigational use of new animal drugs and require
reporting and recordkeeping. The information collected is necessary to
protect the public health. We use the information to determine that
investigational animal drugs are distributed only to qualified
investigators, adequate drug accountability records are maintained, and
edible food products from treated food-producing animals are safe for
human consumption. We also use the information collected to monitor the
validity of the studies submitted to us to support new animal drug
approval.
    Reporting: Our regulations require that certain information be
submitted to us in a ``Notice of Claimed Investigational Exemption for
a New Animal Drug'' (NCIE) to qualify for the exemption and to control
shipment of the new animal drug and prevent potential abuse. The NCIE
must contain, among other things, the following specific information:
(1) Identity of the new animal drug, (2) labeling, (3) statement of
compliance of any non-clinical laboratory studies with good laboratory
practices, (4) name and address of each clinical investigator, (5) the
approximate number of animals to be treated or amount of new animal
drug(s) to be shipped, and (6) information regarding the use of edible
tissues from investigational animals (Sec.  511.1(b)(4) (21 CFR
511.1(b)(4))). If the new animal drug is to be used in food-producing
animals (e.g., cattle, swine, chickens, fish, etc.), certain data must
be submitted to us to obtain authorization for the use of edible food
products from treated food-producing animals (Sec.  511.1(b)(5)). We
require sponsors upon request to submit information with respect to the
investigation to determine whether there are grounds for terminating
the exemption (Sec.  511.1(b)(6)). We require sponsors to report
findings that may suggest significant hazards pertinent to the safety
of the new animal drug (Sec.  511.1(b)(8)(ii)). We also require
reporting by importers of investigational new animal drugs for clinical
investigational use in animals (Sec.  511.1(b)(9)). The information
provided by the sponsor in the NCIE is needed to help ensure that the
proposed investigational use of the new animal drug is safe and that
any edible food will not be distributed without proper authorization
from FDA. Information contained in an NCIE submission is monitored
under our Bioresearch Monitoring Program. This program permits us to
monitor the validity of the studies and to help ensure the proper use
of the drugs is maintained by the investigators.
    Recordkeeping: If the new animal drug is only for tests in vitro or
in laboratory research animals, the person distributing the new animal
drug must maintain records showing the name and post office address of
the expert or expert organization to whom it is shipped and the date,
quantity, and batch or code mark of each shipment and delivery for a
period of 2 years after such shipment or delivery (Sec.  511.1(a)(3)
and (b)(3)). We require complete records of the investigation,
including records of the receipt and disposition of each shipment or
delivery of the investigational new animal drug (Sec.  511.1(b)(7)). We
also require records of all reports received by a sponsor from
investigators to be retained for 2 years after the termination of an
investigational exemption or approval of a new animal drug application
(Sec.  511.1(b)(8)(i)).
    Description of Respondents: Respondents to this collection of
information are persons who use new animal drugs for investigational
purposes. Investigational new animal drugs are used primarily by drug
industry firms, academic institutions, and the government.
Investigators may include individuals from these entities, as well as
research firms and members of the medical professions.
    In the Federal Register of December 21, 2020 (85 FR 83092), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited
and therefore will not be discussed in this document.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
     21 CFR Section/Activity         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
511.1(b)(4); submission of NCIE.             279            5.94           1,657               1           1,657
511.1(b)(5); submission of data              279            0.10              28               8             224
 to obtain authorization for the
 use of edible food products....
511.1(b)(6); submission of any               279           0.001            0.28               1            0.28
 additional information upon
 request of FDA.................
511.1(b)(8)(ii); reporting of                279            0.05              14               2              28
 findings that may suggest
 significant hazards pertinent
 to the safety of the new animal
 drug...........................
511.1(b)(9); reporting by                    279            0.05              14               8             112
 importers of investigational
 new animal drugs for clinical
 investigational use in animals.
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............           1,713  ..............           2,021
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
     21 CFR Section/Activity         Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
511.1(a)(3); maintain records                279            0.99             276               1             276
 showing the name and post
 office address of the expert or
 expert organization to whom the
 new animal drug is shipped and
 the date, quantity, and batch
 or code mark of each shipment
 and delivery for a period of 2
 years after such shipment or
 delivery.......................
511.1(b)(3); maintain records                279            5.94           1,657               1           1,657
 showing the name and post
 office address of the
 investigator to whom the new
 animal drug or feed containing
 same is shipped and the date,
 quantity, and batch or code
 mark of each shipment and
 delivery for a period of 2
 years after such shipment or
 delivery.......................
511.1(b)(7); maintain records of             279            5.94           1,657             3.5           5,800
 the investigation, including
 records of the receipt and
 disposition of each shipment or
 delivery of the investigational
 new animal drug................
511.1(b)(8)(i); maintain records             279            5.94           1,657             3.5           5,800
 of all reports received by a
 sponsor from investigators.....
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............           5,247  ..............          13,533
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimate of the time required for reporting requirements,
record preparation, and maintenance for this collection of information
is based on our informal communication with industry. Based on the
number of sponsors subject to animal drug user fees, we estimate that
there are 279 respondents. We use this estimate consistently throughout
the table and calculate the ``number of responses per respondent'' by
dividing the total annual responses by number of respondents. We note
an apparent difference in the estimated number of respondents from the
previous renewal issued in 2018. There was an error in calculating the
number of sponsors subject to animal drug user fees in the 2018
renewal. When calculating the number of recordkeepers, we inadvertently
used the number of sponsors that paid user fees (i.e., those that did
not qualify for user fee waivers) as opposed to the total number of
sponsors subject to animal drug user fees. Both fee-paying and non-fee-
paying sponsors are respondents with respect to this information
collection.
    Additional information needed to make a final calculation of the
total burden hours (i.e., the number of respondents, the number of
recordkeepers, the number of NCIEs received, etc.) is derived from our
records. There is a small increase in the total burden hours that we
attribute to an increase in the number of annual responses and records.

    Dated: June 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12197 Filed 6-9-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 208 (Friday, October 28, 2022)]
[Notices]
[Pages 65268-65271]
[FR Doc No: 2022-23482]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96136; File No. SR-FICC-2022-006]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
Order Granting Approval of Proposed Rule Change To Increase the Minimum
Required Fund Deposit for Government Securities Division Netting
Members and Sponsoring Members, and Make Other Changes

October 24, 2022.

I. Introduction

    On September 9, 2021, Fixed Income Clearing Corporation (``FICC'')
filed with the Securities and Exchange Commission (``Commission'')
proposed rule change SR-FICC-2022-006 (the ``Proposed Rule Change'')
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder \2\ to increase the minimum
Required Fund Deposit for members of FICC's Government Securities
Division (``GSD'') \3\ members, as well as make certain clarifying and
technical changes.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ FICC operates two divisions, GSD and the Mortgage Backed
Securities Division (``MBSD''). GSD provides trade comparison,
netting, risk management, settlement, and central counterparty
(``CCP'') services for the U.S. Government securities market,
including repos. MBSD provides the same services for the U.S.
mortgage-backed securities market. GSD and MBSD maintain separate
sets of rules, margin models, and clearing funds. The proposed rule
change relates solely to GSD, except as discussed in section II.B at
note 19 infra.
---------------------------------------------------------------------------

    The Proposed Rule Change was published for comment in the Federal
Register on September 22, 2022,\4\ and the Commission has received no
comments on the changes proposed therein. This order approves the
Proposed Rule Change.
---------------------------------------------------------------------------

    \4\ Securities Exchange Act Release No. 95806 (Sept. 16, 2022),
87 FR 57960 (Sept. 22, 2022) (File No. SR-FICC-2022-006) (``Notice
of Filing'').
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

    Currently, FICC requires from each Netting Member a minimum
required margin amount, referred to as the Required Fund Deposit, of
$100,000 that must be made and maintained in cash, and does not require
any specific minimum amount for Sponsoring Members.\5\ FICC proposes to
increase each member's minimum Required Fund Deposit amount to
$1,000,000.
---------------------------------------------------------------------------

    \5\ Rule 4, section 3 (for Netting Members) and Rule 3A, section
10(c) (for Sponsoring Members). Capitalized terms not defined herein
are defined in the GSD Rules & Procedures (``Rules''), available at
https://www.dtcc.com/~/media/Files/Downloads/legal/rules/
ficc_gov_rules.pdf. For purposes of this order, ``member'' will be
used to describe Netting Members and Sponsoring Members,
collectively.
---------------------------------------------------------------------------

A. Background

    A key tool that FICC uses to manage its respective credit exposures
to its members is the daily collection of margin from each member,
which is referred to as each member's Required Fund Deposit. The
aggregated amount of all members' margin constitutes the Clearing Fund,
which FICC would access should a defaulted member's own margin be
insufficient to satisfy losses to FICC caused by the liquidation of
that member's portfolio.
    FICC conducts daily backtesting to evaluate whether each member's
Required Fund Deposit is sufficient to cover FICC's credit exposures to
that member based on a simulated liquidation of the member's portfolio
on that day.\6\ Backtesting is an ex-post comparison of actual outcomes
with expected outcomes derived from the use of margin models.\7\ A
backtesting deficiency occurs when FICC determines that the projected
liquidation losses to FICC arising in the event of a member's default
would be greater than the member's Required Fund Deposit.\8\ Therefore,
backtesting deficiencies highlight exposure that could subject FICC to
potential losses under normal market conditions in the event that a
member defaults.\9\
---------------------------------------------------------------------------

    \6\ The Model Risk Management Framework (``Model Risk Management
Framework'') sets forth the model risk management practices of FICC
and states that Value at Risk (``VaR'') and Clearing Fund
requirement coverage backtesting is performed on a daily basis or
more frequently. See Securities Exchange Act Release Nos. 81485
(Aug. 25, 2017), 82 FR 41433 (Aug. 31, 2017) (SR-FICC-2017-014),
84458 (Oct. 19, 2018), 83 FR 53925 (Oct. 25, 2018) (SR-FICC-2018-
010), 88911 (May 20, 2020), 85 FR 31828 (May 27, 2020) (SR-FICC-
2020-004), 92380 (July 13, 2021), 86 FR 38140 (July 19, 2021) (SR-
FICC-2021-006), and 94271 (Feb. 17, 2022), 87 FR 10411 (Feb. 24,
2022) (SR-FICC-2022-001).
    \7\ See 17 CFR 240.17Ad-22(a)(1).
    \8\ See Notice of Filing, supra note 4, at 57691.
    \9\ Id.
---------------------------------------------------------------------------

    FICC regularly reviews backtesting results to assess the
effectiveness of its margin requirements.\10\ As part of its review,
FICC investigates the causes of any backtesting deficiencies, paying
particular attention to repeat backtesting deficiencies that would
result in the member's backtesting coverage to fall below the 99%
confidence target to determine if there is an identifiable cause of
repeat backtesting deficiencies.\11\ FICC also evaluates whether
multiple members may experience backtesting deficiencies for the same
underlying reason.\12\
---------------------------------------------------------------------------

    \10\ Id.
    \11\ FICC states that a member's backtesting coverage would fall
below the 99% confidence target if the member has more than two
backtesting deficiency days in a rolling twelve-month period. Id. In
other words, if a member has three or more backtesting deficiency
days during a twelve-month period, then the member's margin would
not be sufficient 99% of the time. FICC believes that its targeted
99% confidence level is consistent with its regulatory requirements
under Rule 17Ad-22(e)(4)(i) and (e)(6)(iii). Id.; see also 17 CFR
240.17Ad-22 (e)(4)(i), and (e)(6)(iii).
    \12\ See Notice of Filing, supra note 4, at 57961.
---------------------------------------------------------------------------

    Based on its regular reviews, FICC has found that members with
Required Fund Deposits below $100,000 disproportionately experience
repeat backtesting deficiencies because, should the member's settlement
activity abruptly increase, the additional exposure to FICC would not
be mitigated until the collection of the Required Fund Deposit either
intraday or on the next business day.\13\ FICC states it has also found
that its current minimum margin requirement of $100,000 is
disproportionately lower than the minimum margin requirements of other
CCPs that clear similar securities products.\14\
---------------------------------------------------------------------------

    \13\ Id. at 57961-62.
    \14\ See Notice of Filing, supra note 4, at 57962 (citing the
following requirements: the Options Clearing Corporation's (``OCC'')
minimum initial contribution of $500,000, see OCC Rule 1002(d),
available at https://www.theocc.com/getmedia/9d3854cd-b782-450f-bcf7-33169b0576ce/occ_rules.pdf; the Chicago Mercantile Exchange's
(``CME'') minimum requirement of $500,000 or $2.5 million depending
on the product types being cleared, see CME Rule 816, available at
https://www.cmegroup.com/content/dam/cmegroup/rulebook/CME/I/8/8.pdf; the National Securities Clearing Corporation's (``NSCC'')
minimum required fund deposit of $250,000, see NSCC Rule 4,
available at https://dtcc.com/~/media/Files/Downloads/legal/rules/
nscc_rules.pdf.; LCH Limited's minimum default fund contribution of
GBP 500,000 (approximately $566,000 based on current foreign
currency exchange rate) and of GBP 2,000,000 (approximately $2.3
million based on the current foreign currency exchange rate) for
RepoClear, see LCH Limited Default Rules definition of ``Minimum
Contribution'' and ``Minimum RepoClear Contribution'' available at
https://www.lch.com/system/files/media_root/210609_Default%20Rules_Clean_0.pdf; and Ice Clear U.S.'s minimum
contribution to Guaranty Fund of $2 million, see ICE Clear U.S. Rule
301, available at https://www.ice.com/publicdocs/rulebooks/clear/ICE_Clear_US_Rules.pdf).
---------------------------------------------------------------------------

B. Proposal

    In the Proposed Rule Change, FICC proposes to increase its minimum
Required Fund Deposit for its members to $1,000,000.
    Specifically, to implement this change for Netting Members, FICC
would revise Section 2(a) of Rule 4 to state that each Netting Member
shall be required to make a Required Fund Deposit to the Clearing Fund
equal to the greater of (i) the Minimum Charge or (ii) the Total
Amount. FICC would also revise section 3 of GSD Rule 4 to replace the
minimum cash amount from $100,000 to $1 million, to match the proposed

increased minimum Required Fund Deposit amount. To implement this
change for Sponsoring Members, FICC would revise section 10(c) of Rule
3A (Sponsoring Members and Sponsored Members) to state that the
Sponsoring Member Omnibus Account Required Fund Deposit shall be equal
to the greater of: (i) $1 million or (ii), which is what is currently
in the Rules, the sum of the following: (1) the sum of the VaR Charges
\15\ for all of the Sponsored Members whose activity is represented in
the Sponsoring Member Omnibus Account as derived pursuant to, and (2)
all amounts representing other components of the Sponsoring Member's
Required Fund Deposit computed at the level of the Sponsoring Member
Omnibus Account, other than the VaR Charge. In addition, Section 10(d)
of Rule 3A would be revised to replace the minimum cash amount from
$100,000 to $1 million to match the proposed increased minimum Required
Fund Deposit amount for the Sponsoring Members.\16\
---------------------------------------------------------------------------

    \15\ For Sponsoring Member's the VaR Charge is determined
pursuant to Section 1b(a)(i) of GSD Rule 4 (Clearing Fund and Loss
Allocation). The VaR Charge is generally the largest component of
the Required Fund Deposit. It is designed to provide an estimate of
FICC's projected liquidation losses with respect to a defaulted
member's portfolio at a 99 percent confidence level, and it is based
on the potential price volatility of unsettled positions using a
sensitivity-based Value-at-Risk model. As an alternative to this
calculation, FICC also uses a haircut-based calculation as the
member's VaR Charge if that charge exceeds the amount determined by
the model-based calculation. Fixed Income Clearing Corporation
Disclosure Framework for Covered Clearing Agencies and Financial
Market Infrastructures, at 64, available at https://www.dtcc.com/media/Files/Downloads/legal/policy-and-compliance/FICC_Disclosure_Framework.pdf; see also Exchange Act Release No.
92303 (June 30, 2021), 86 FR 35855 (July 7, 2021).
    \16\ See Notice of Filing, supra note 4, at 57963.
---------------------------------------------------------------------------

    For Repo Brokers, FICC would not propose to change the current
minimum Required Fund Deposit of $5 million.\17\ However, for clarity,
FICC would propose to move the minimum Required Fund Deposit to a
different section of the Rules, to improve organization.\18\
---------------------------------------------------------------------------

    \17\ Rule 4, section 1b, supra note 5. Currently, if a Repo
Broker has two Margin Portfolios, with Broker Account(s) in one
Margin Portfolio and Dealer Account(s) in the other Margin
Portfolio, the total minimum Required Fund Deposit applicable to the
Repo Broker would be $5.1 million, i.e., $5 million minimum Required
Fund Deposit for the Margin Portfolio with Broker Account(s) and
$100,000 minimum Required Fund Deposit for the Margin Portfolio with
Dealer Account(s).
    \18\ FICC would also make revisions to state that the Minimum
Charge applicable to each Repo Broker shall be no less than $5
million for each Margin Portfolio with Broker Account(s) and no less
than $1 million for each Margin Portfolio with Dealer Account(s),
and to refer to additional payments, charges and premiums being
applied by FICC after application of Minimum Charges, which term
replaces the current term ``minimum Clearing Fund amounts.''
---------------------------------------------------------------------------

    Finally, FICC proposes to add a sentence to Section 2 of MBSD Rule
4, which addresses required clearing fund deposits, to make clear that,
as is currently the case due to other portions of the rule, the Minimum
Charge for each margin portfolio of a Clearing Member shall be no less
than $100,000.\19\ FICC also proposes to replace (i) ``Clearing Fund
requirement'' with ``Minimum Charge for each margin portfolio'' and
(ii) ``minimum Clearing Fund amounts'' with ``Minimum Charges'' in MBSD
Rule 4, section 2, which FICC believes will enhance clarity.
Furthermore, FICC is proposing a technical change to correct a
reference to the non-Unregistered Investment Pool Clearing Member in
MBSD Rule 4, section 2.
---------------------------------------------------------------------------

    \19\ Specifically, Rule 4, section 3 of the MBSD Rules, which
addresses the form of a member's required fund deposit, states that
a member must make deposit the lesser of $5,000,000 or 10 percent of
its required fund deposit, with a minimum of $100,000, in cash. The
MBSD Rules are available at https://www.dtcc.com/~/media/Files/
Downloads/legal/rules/ficc_mbsd_rules.pdf (``MBSD Rules'').
---------------------------------------------------------------------------

C. Impact Study Results

    To support its proposal, FICC relies upon the results of recent
analyses of backtesting and margin.\20\ Specifically, FICC examines the
backtesting coverage of each of its members during the period for a 12-
month period ending June 30, 2022 (``Backtesting Impact Study'') under
the current $100,000 minimum GSD Required Fund Deposit amount compared
to hypothetical (or ``pro forma'') minimum GSD Required Fund Deposit
amounts, including the proposed $1,000,000 amount. The Backtesting
Impact Study shows that the number of member backtesting deficiencies
that would have been eliminated during the period had FICC's minimum
GSD Required Fund Deposit been $1,000,000 compared to $100,000. FICC
then uses the Backtesting Impact Study to analyze the improvement to
each member's backtesting coverage ratio and, taking all members'
backtesting coverage ratio results together, to FICC's Clearing Fund
backtesting coverage.\21\
---------------------------------------------------------------------------

    \20\ FICC provided a public summary of the information in this
Section II.B in its Notice of Filing, upon which this discussion is
based. See Notice of Filing, supra note 4, at 57962-3. FICC
submitted the data underlying these analyses as a confidential
Exhibit 3 to the Proposed Rule Change pursuant to 17 CFR 240.24b-2.
    \21\ The backtesting coverage represents the daily sufficiency
of the aggregate of all members' margin over a rolling 12-month
period. As described in Section II.A above, FICC would be able to
access its clearing fund to cover any losses to it should a member
with insufficient margin default. GSD Rule 4, Section 3, supra note
3.
---------------------------------------------------------------------------

    According to FICC, the Backtesting Impact Study indicates that
using $1 million as GSD's minimum Required Fund Deposit amount would
have reduced the number of members with backtesting coverage below 99%.
Specifically, the Backtesting Impact Study shows 70 members below 99%
backtesting coverage as of June 30, 2022 with a collective 396
backtesting deficiencies in GSD. Approximately 21% (i.e., 85 out of
396) of the backtesting deficiencies occurred with respect to members
that had a Required Fund Deposit of less than $1 million on the
relevant deficiency day(s). FICC states that if the proposed changes
had been in place during the Backtesting Impact Study period,
approximately 16% (i.e., 65 out of 396) of the backtesting deficiencies
incurred by the members would have been eliminated, and the total
number of members that were below the 99% confidence target as of June
30, 2022 would have been reduced by 8. Overall, FICC states that a $1
million minimum requirement would have increased GSD's 12-month
backtesting coverage 0.22%, eliminated 65 backtesting deficiencies, and
improved the rolling twelve-month backtesting coverage for 8 members to
above 99% confidence target.
    In addition, FICC conducted a clearing fund requirement impact
study for the period of July 1, 2021 to June 30, 2022 (``CFR Impact
Study'') on a member-level basis, meaning that it examined the effect
on each member's Required Fund Deposit had the proposal been in place.
According to FICC, the CFR Impact Study indicates that under the
proposal, approximately 47% (81 out of a total of 174) of the current
members' Margin Portfolios would have been impacted, with an average
and a weighted average (with weights based on number of impacted days)
additional Required Fund Deposit of approximately $686,000 and
$792,000, respectively, for each such Margin Portfolio per impacted
day. When comparing the actual, total Clearing Fund deposit of the
current members' Margin Portfolios (that is, including any additional
resources held at FICC in addition to the Required Fund Deposit) with
the proposed minimum Required Fund Deposit amount, however, only
approximately 13% (23 out of a total 174) of such members' Margin
Portfolios would have been impacted, requiring an average and a
weighted average (with weights based on number of impacted days)
additional cash deposit of approximately $649,000 and $715,000,
respectively, for each such Margin Portfolio per impacted day. FICC
states the result of the CFR Impact Study also shows one Repo Broker
that would have

been impacted, requiring additional Clearing Fund deposit of
approximately $392,000 in either cash or Eligible Clearing Fund
Securities per impacted day. Overall, FICC states that the proposed
changes would have resulted in an average increase in the daily
required margin amount, for all members' deposits in the aggregate, of
$31.4 million (or 0.17%) at GSD during the CFR Impact Study period.

III. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act \22\ directs the Commission to
approve a proposed rule change of a self-regulatory organization if it
finds that such proposed rule change is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to such organization. After careful consideration, the
Commission finds that the Proposed Rule Change is consistent with the
requirements of the Act and the rules and regulations applicable to
FICC.\23\ In particular, the Commission finds that the Proposed Rule
Change is consistent with Section 17A(b)(3)(F) and (b)(3)(I) \24\ of
the Act and Rules 17Ad-22(e)(4) and (e)(6) thereunder.\25\
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    \22\ 15 U.S.C. 78s(b)(2)(C).
    \23\ The Commission's findings are based on its review of the
Proposed Rule Change, including its analysis of the Backtesting and
CFR Impact Studies, which are summarized in Section II.B above. See
supra note 20 and accompanying text.
    \24\ 15 U.S.C. 78q-1(b)(3)(F).
    \25\ 17 CFR 240.17Ad-22(e)(4) and (e)(6).
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A. Consistency With Section 17A(b)(3)(F) of the Act

    Section 17A(b)(3)(F) of the Act requires, in part, that the rules
of a clearing agency, such as FICC, be designed, in part, to assure the
safeguarding of securities and funds which are in the custody or
control of the clearing agency or for which it is responsible.\26\ The
Commission believes that the Proposed Rule Change is consistent with
Section 17A(b)(3)(F) of the Act.
---------------------------------------------------------------------------

    \26\ 15 U.S.C. 78q-1(b)(3)(F).
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    As discussed in Section II.A above, backtesting deficiencies
highlight when a member's margin is insufficient to cover FICC's credit
exposure to that member. If a defaulted member's margin is insufficient
to satisfy losses caused by the closeout of that member's positions,
FICC and its non-defaulting members may be subject to losses. As
summarized in Section II.B above, and based on the Commission's review
and analysis of the material submitted by FICC,\27\ the proposed
increase would have provided FICC with additional resources, which
would have resulted in a decrease in backtesting deficiencies and thus
a reduction in credit exposure to its members under the proposal.
Therefore, the Commission believes FICC would improve the probability
that the increased minimum margin amount it collects is sufficient to
cover FICC's credit exposure to those members, particularly in
instances where the defaulted member's clearing activity abruptly
increases following a period of low or no activity because FICC would
have additional resources available to cover that additional exposure
before collecting additional margin for that increased activity. This
increase could reduce the possibility that FICC or its non-defaulting
members face losses from the close-out process, in the event that FICC
were to have to allocate losses amongst non-defaulting losses pursuant
to its Rules.
---------------------------------------------------------------------------

    \27\ See supra note 20.
---------------------------------------------------------------------------

    Moreover, FICC would continue to require that members pay an amount
equal to the minimum Required Fund Deposit amount in cash. The proposal
therefore would enable FICC to have available additional collateral
that is easier for FICC to access quickly to complete end of day
settlement upon a member's default, further reducing the risk of losses
to FICC or non-defaulting members. Accordingly, the Commission believes
the Proposed Rule Change would promote the safeguarding of securities
and funds which are in the custody or control of FICC or for which FICC
is responsible, consistent with Section 17A(b)(3)(F) of the Act.
    Finally, as discussed in Section II.B above, FICC proposes
clarifying and technical changes to the GSD and MBSD Rules. Such
changes provide clarifications to members regarding the definitions and
applications of Rules. The Commission believes that such changes would
ensure that the Rules are accurate and clear to members, thus promoting
prompt and accurate clearance and settlement, which is consistent with
Section 17A(b)(3)(F) of the Act.\28\
---------------------------------------------------------------------------

    \28\ 15 U.S.C. 78q-1(b)(3)(F).
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B. Consistency With Section 17A(b)(3)(I) of the Act

    Section 17A(b)(3)(I) of the Act requires that the rules of a
clearing agency do not impose any burden on competition not necessary
or appropriate in furtherance of the Act.\29\ This provision does not
require the Commission to find that a proposed rule change represents
the least anti-competitive means of achieving the goal.\30\ Rather, it
requires the Commission to balance the competitive considerations
against other relevant policy goals of the Act.
---------------------------------------------------------------------------

    \29\ 15 U.S.C. 78q-1(b)(3)(I).
    \30\ See Bradford National Clearing Corp., 590 F.2d 1085, 1105
(D.C. Cir. 1978).
---------------------------------------------------------------------------

    The Commission acknowledges that the impact of increased margin
requirements may present higher costs to some members with lower
operating margins, lower cash reserves or higher costs of capital
compared to other members, which may weaken those members' competitive
positions relative to others. Although some of FICC's members could
experience a burden on competition because of these higher costs, the
Commission concludes any burden to these members is necessary and
appropriate in furtherance of the policy goals under the Act \31\ for
the following reasons.
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    \31\ 15 U.S.C. 78q-1(b)(3)(I). Specifically, as discussed in
greater detail in Section III.C and III.D below, the Proposed Rule
Change is necessary and appropriate to further the policy goals
under Rule 17Ad-22(e)(4)(i) and (e)(6)(iii), 17 CFR 240.17Ad-
22(e)(4)(i) and (e)(6)(iii).
---------------------------------------------------------------------------

    As discussed in Section II.A above, FICC seeks to maintain
sufficient resources (i.e., margin) to cover its credit exposures to
its members fully with a high degree of confidence. Conversely, FICC
uses backtesting to determine when a member's margin would have been
insufficient to cover FICC's credit exposure to that member. As
previously discussed, the Backtesting Impact Study shows the proposed
$1,000,000 minimum Required Fund Deposit would have decreased the
number of backtesting deficiencies, thereby increasing the number of
members for which FICC maintained sufficient coverage at a confidence
level of at least 99%. Therefore, the Proposed Rule Change would enable
FICC to better manage its credit exposure to its members by ensuring it
holds sufficient collateral to cover that exposure, thereby reducing
the likelihood that FICC or non-defaulting members would incur losses
resulting from a member default.
    Additionally, as described in Section II.B, FICC conducted a
Clearing Fund impact study. Specifically, when comparing the actual,
total Clearing Fund deposit of the current members' Margin Portfolios
with the proposed minimum Required Fund Deposit amount, approximately
13% (23 out of a total 174) of such members' Margin Portfolios would
have been impacted, requiring an average and a weighted average (with
weights based on number of impacted days) additional cash deposit of
approximately $649,000 and $715,000, respectively, for each such

Margin Portfolio per impacted day. The result of the CFR Impact Study
also shows one Repo Broker that would have been impacted, requiring an
additional margin deposit of approximately $392,000 in either cash or
Eligible Clearing Fund Securities per impacted day. Overall, the
proposed changes would have resulted in an average increase in daily
Required Fund Deposit of $31.4 million (or 0.17%) at GSD during the CFR
Impact Study period.
    Finally, according to FICC, when comparing the average additional
cash deposit amounts that members would be required to make if the
minimum Clearing Fund cash deposit at GSD had been increased to
$1,000,000 with their respective average Net Capital during the CFR
Impact Study period, the largest average additional cash deposit amount
represented approximately 0.49% of the affected member's average Net
Capital.\32\ In addition, when comparing the average additional
Clearing Fund deposit that members would be required to make, either in
cash or Eligible Clearing Fund Securities, if the minimum Required Fund
Deposit amount at GSD had been increased as proposed with their
respective average Net Capital during the CFR Impact Study period, the
largest average additional Clearing Fund deposit amount represented
approximately 1.46% of the affected member's average Net Capital.\33\
In light of this analysis, and our review of the confidential data
underlying the CFR Impact Study, the Commission believes that the
majority of impacted members likely would not experience a weakened
competitive position compared to others as a result of the Proposed
Rule Change.
---------------------------------------------------------------------------

    \32\ Notice of Filing, supra note 4, at 57965.
    \33\ Id.
---------------------------------------------------------------------------

    Therefore, the Commission concludes that any competitive burden to
members imposed by the Proposed Rule Change is necessary and
appropriate in furtherance of the Act. Accordingly, the Commission
finds that the Proposed Rule Change is consistent with the requirements
of Section 17A(b)(3)(I) of the Act.\34\
---------------------------------------------------------------------------

    \34\ 15 U.S.C. 78q-1(b)(3)(I).
---------------------------------------------------------------------------

C. Consistency With Rule 17Ad-22(e)(4)(i)

    Rule 17Ad-22(e)(4)(i) requires that FICC establish, implement,
maintain and enforce written policies and procedures reasonably
designed to effectively identify, measure, monitor, and manage its
credit exposures to participants and those arising from its payment,
clearing, and settlement processes, including by maintaining sufficient
financial resources to cover its credit exposure to each participant
fully with a high degree of confidence.\35\
---------------------------------------------------------------------------

    \35\ 17 CFR 240.17Ad-22(e)(4)(i).
---------------------------------------------------------------------------

    As described above in Section II.A, FICC and its non-defaulting
members may be subject to losses should a defaulted member's own
Required Fund Deposit be insufficient to satisfy losses caused by the
liquidation of that member's portfolio. As summarized in Section II.B
above and based on the Commission's review and analysis of the
underlying data,\36\ the Backtesting Impact Study shows a $1,000,000
minimum Required Fund Deposit would have decreased the number of
backtesting deficiencies, which would likely help FICC better manage
its credit exposure to each of its members and credit exposures arising
from its payment, clearing, and settlement processes.
---------------------------------------------------------------------------

    \36\ See supra note 23.
---------------------------------------------------------------------------

    Additionally, as discussed in Section II.B above, FICC would
continue to require that members pay an amount equal to the minimum
Required Fund Deposit amount in cash, which should enable FICC to
better maintain sufficient prefunded margin to mitigate potential
future exposures to its members. Therefore, requiring the proposed
minimum $1,000,000 deposit to be made in cash should reduce the
probability that FICC or non-defaulting members would incur losses
resulting from a member default. Accordingly, the Commission finds that
FICC's proposed increase to its minimum Required Fund Deposit would be
consistent with Rule 17Ad-22(e)(4)(i).\37\
---------------------------------------------------------------------------

    \37\ 17 CFR 240.17Ad-22(e)(4)(i).
---------------------------------------------------------------------------

D. Consistency With Rule 17Ad-22(e)(6)(iii)

    Rule 17Ad-22(e)(6)(iii) under the Act requires that a covered
clearing agency establish, implement, maintain and enforce written
policies and procedures reasonably designed to cover its credit
exposures to its participants by establishing a risk-based margin
system that, at a minimum, calculates margin sufficient to cover its
potential future exposure to members in the interval between the last
margin collection and the close out of positions following a member
default.\38\
---------------------------------------------------------------------------

    \38\ 17 CFR 240.17Ad-22(e)(6)(iii).
---------------------------------------------------------------------------

    As summarized in Section II.A above, FICC employs daily backtesting
to determine the adequacy of each member's Required Fund Deposit paying
particular attention to members that have backtesting deficiencies
below the 99% confidence target. Such backtesting deficiencies
highlight exposure that could subject FICC to potential losses if a
member defaults.
    Based on the Backtesting Impact Study, which the Commission has
reviewed and analyzed, approximately 21% of all backtesting
deficiencies occur for those members that maintain a Required Fund
Deposit of less than $1,000,000, and approximately 16% of the
deficiencies of those members would have been eliminated during the
Impact Study Period if the Required Fund Deposit were $1,000,000 or
higher. By raising the minimum Required Fund Deposit amount to
$1,000,000, the Commission believes the proposal should enable FICC to
decrease the number of backtesting deficiencies by members, thereby
improving FICC's backtesting coverage, and thus decrease FICC's
exposure to such members in the event of a member default.
    Therefore, the Commission concludes FICC's Proposed Rule Change
should better ensure FICC maintains sufficient margin to cover its
potential future exposure to its members in the interval between the
last margin collection and the close out of positions following a
member default, thereby reducing the likelihood FICC or non-defaulting
members would incur losses as a result. Accordingly, the Commission
finds that FICC's proposed increase to its minimum Required Fund
Deposit would be consistent with Rule 17Ad-22(e)(6)(iii).\39\
---------------------------------------------------------------------------

    \39\ 17 CFR 240.17Ad-22(e)(6)(iii).
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
Proposed Rule Change is consistent with the requirements of the Act and
in particular with the requirements of Section 17A of the Act \40\ and
the rules and regulations promulgated thereunder.
---------------------------------------------------------------------------

    \40\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act
\41\ that Proposed Rule Change SR-FICC-2022-006, as modified by Partial
Amendment No. 1, be, and hereby is, approved.\42\
---------------------------------------------------------------------------

    \41\ 15 U.S.C. 78s(b)(2).
    \42\ In approving the Proposed Rule Change, the Commission
considered the proposals' impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f). See discussion supra Section
III.B.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\43\
---------------------------------------------------------------------------

    \43\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-23482 Filed 10-27-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 24 (Monday, February 6, 2023)]
[Notices]
[Pages 7739-7741]
[FR Doc No: 2023-02482]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-E-1978]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by April 7, 2023.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by August 7, 2023. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 7, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.

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-2019-E-1978 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; DOPTELET.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be

placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, DOPTELET
(avatrombopag maleate). DOPTELET is indicated for the treatment of
thrombocytopenia in adult patients with chronic liver disease who are
scheduled to undergo a procedure. Subsequent to this approval, the
USPTO received a patent term restoration application for DOPTELET (U.S.
Patent No. 7,638,536) from Astellas Pharma Inc., and the USPTO
requested FDA's assistance in determining the patent's eligibility for
patent term restoration. In a letter dated June 21, 2019, FDA advised
the USPTO that this human drug product had undergone a regulatory
review period and that the approval of DOPTELET represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
DOPTELET is 4,632 days. Of this time, 4,389 days occurred during the
testing phase of the regulatory review period, while 243 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
September 16, 2005. The applicant claims October 3, 2005, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was September
16, 2005, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: September 21,
2017. FDA has verified the applicant's claim that the new drug
application (NDA) for DOPTELET (NDA 210238) was initially submitted on
September 21, 2017.
    3. The date the application was approved: May 21, 2018. FDA has
verified the applicant's claim that NDA 210238 was approved on May 21,
2018.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,826 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02482 Filed 2-3-23; 8:45 am]
BILLING CODE 4164-01-P