[Federal Register Volume 86, Number 35 (Wednesday, February 24, 2021)]
[Notices]
[Pages 11278-11281]
[FR Doc No: 2021-03730]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. AD21-6-000; AD20-6-000]

RTO/ISO Credit Principles and Practices; Credit Reforms in
Organized Wholesale Electric Markets Supplemental Notice of Technical
Conference

    As first announced in the Notice of Technical Conference issued in
this proceeding on November 4, 2020, the Federal Energy Regulatory
Commission (Commission) will convene a staff-led technical conference
in the above referenced proceeding on Thursday,

February 25, 2021 from 9:00 a.m. to 5:00 p.m. and Friday, February 26,
2021 from 9:00 a.m. to 1:00 p.m. Eastern Time. The conference will be
held electronically and broadcast on the Commission's website.
Commissioners may attend and participate. This conference will discuss
principles and best practices for credit risk management in organized
wholesale electric markets.
    We note that discussions at the conference may involve issues
raised in proceedings that are currently pending before the Commission.
These proceedings include, but are not limited to:

DC Energy, LLC v. PJM Interconnection, L.L.C., Docket No. EL18-170;
Shell Energy North America (US), L.P., Docket No. EL20-49;
PJM Interconnection, L.L.C., Docket No. ER21-520;
ISO New England Inc., New England Power Pool Participants Committee,
Docket No. ER21-816;
Midcontinent Independent System Operator, Inc., Docket No. ER21-920.

    Attached to this Supplemental Notice is an agenda for the technical
conference, which includes the final conference program and speakers.
The conference will be open for the public to attend. Registration for
the conference is not required, however members of the public may
preregister online at: https://ferc.webex.com/ferc/onstage/g.php?MTID=e2b36f2a0411532188b8cd973144668ff. Anyone who registers by
Monday, February 22, 2021 will be given instructions on how to access
the event. Information on the technical conference will also be posted
on the Calendar of Events on the Commission's website, http://www.ferc.gov, prior to the event. The conference will be transcribed.
Transcripts of the conference will be available for a fee from Ace-
Federal Reporters, Inc.<PHONE_NUMBER>).
    For more information about this technical conference, please
contact:

Michael Hill (Technical Information), Office of Energy Policy and
Innovation,<PHONE_NUMBER><EMAIL_ADDRESS>Sarah McKinley (Logistical Information), Office of External Affairs,
(202) 502-8004<EMAIL_ADDRESS>
    Dated: February 10, 2021. .
Kimberly D. Bose,
Secretary.

RTO/ISO Credit Principles and Practices Technical Conference

Docket Nos. AD21-6-000 and AD20-6-000

February 25-26, 2021

Agenda and Speakers
Day 1--Thursday, February 25, 2021
9:00 a.m.-9:15 a.m.: Welcome and Opening Remarks
9:15 a.m.-10:45 a.m.: Panel 1: Credit Principles and Practices in RTO/
ISO Markets
    Scott Miller, Principal, Whitehall Bay Energy Services
    Bob Wasserman, Chief Counsel, Division of Clearing and Risk, U.S.
Commodity Futures Trading Commission
    Vince Kaminski, Professor in the Practice of Energy, Rice
University
    Geoffrey Harris, Knowledge Leader II, Federal Reserve Bank of
Chicago
    Erik Heinle, Assistant People's Counsel, Office of the People's
Counsel for the District of Columbia
    Ted Thomas, Chairman, Arkansas Public Service Commission

    This panel will explore the fundamental principles underlying
credit risk management and the panelists' understanding of how those
principles are applied within RTO/ISO markets. Panelists will discuss
how credit risk is managed and regulated in other industries and
whether any best practices can be applied to the RTO/ISO markets. This
panel will also discuss the RTO/ISO credit policy requirements set
forth in Order No. 741 \1\ and whether there is a need for the
Commission to update those requirements. The panel may include a
discussion of the following topics and questions:
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    \1\ Credit Reforms in Organized Wholesale Electric Markets,
Order No. 741, 133 FERC ] 61,060 (2010), order on reh'g, Order No.
741-A, 134 FERC ] 61,126 (2011), reh'g denied, Order No. 741-B, 135
FERC ] 61,242 (2011).
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    1. What is credit risk and who bears the credit risk in RTO/ISO
markets? How can RTOs/ISOs better understand and minimize the credit
risk that their market participants pose?
    2. What are the key components of an effective credit policy? What
principles and best practices of credit risk management are applicable
to RTO/ISO markets?
    3. What impact has Order No. 741 had in reducing credit risk? Are
there aspects of credit policy beyond those addressed by Order No. 741
which should be explored? Are there areas where the Commission can and
should provide additional guidance or regulations to mitigate credit
risk?
    4. What types of credit structures or market designs (in terms of
moving some products to financial exchanges or central clearing
parties, increasing mark-to-market frequency, collateral practices,
liquidity) could be set up to reduce the likelihood that non-defaulting
market participants bear the costs of a market participant defaulting?
How would such structures or designs affect participants' access to the
markets?

10:45 a.m.-11:00 a.m.: Break
11:00 a.m.-12:30 p.m.: Panel 2: RTO/ISO Comparison of Risk Management
Structure, Credit Enhancements and Lessons Learned
    Ryan Seghesio, Vice President, Chief Financial Officer and
Treasurer, California ISO
    Scott Smith, Director of Treasury and Risk Management, Southwest
Power Pool
    Melissa Brown, Senior Vice President and Chief Financial Officer,
Midcontinent ISO
    Nigeria Bloczynski, Chief Risk Officer, PJM Interconnection, LLC
    Sheri Prevratil, Manager of Corporate Credit, New York ISO

    This panel will compare and contrast the risk management
structures, credit practices, and recent credit enhancements
implemented by the RTOs/ISOs. This panel will present an overview of
each RTOs'/ISOs' experience in managing credit risk and will allow the
panelists to ask questions of one another to facilitate the exchange of
best practices. The panel may include a discussion of the following
topics and questions:
    1. How is the risk management function in your RTO/ISO structured?
What are the tools and resources (in terms of personnel, data,
software, etc.) your risk department uses to implement the RTO's/ISO's
credit policy? How do you evaluate a new or existing market
participant's risk of default? When and how do you communicate with
market participants to obtain information or to convey credit concerns?
To what extent do you communicate with other departments within the
RTO/ISO regarding credit risk concerns in the RTO/ISO markets?
    2. To what extent does the RTO/ISO need discretion to implement its
credit policy to protect the markets from the risk of market
participant defaults? Does your RTO/ISO currently have such discretion?
How should this discretion be balanced with the need to ensure non-
discriminatory treatment of market

participants? What remedies, if any, do you currently have available to
market participants suspended or rejected for posing an unreasonable
credit risk to the RTO/ISO markets?
    3. What significant enhancements has your RTO/ISO made to its
credit policy in recent years? What tools and resources did it require
to implement these enhancements? What lessons has your risk department
learned in implementing these enhancements? What would you recommend to
other RTOs/ISOs considering similar enhancements?
    4. Do certain RTO/ISO products (such as virtuals) or aspects of
market design pose greater credit risk than others? How, if at all,
have recent market design changes impacted the credit risk in the RTO/
ISO markets, particularly the Financial Transmission Rights (FTR)
markets (e.g., limiting the available FTR contract paths, altering the
FTR capacity available at auction, or changing the frequency of long-
term FTR auctions)? To what extent is the risk department involved in
discussions of market design changes?
    5. What Know Your Customer protocols do RTOs/ISOs have in place,
and are they adequate? Are RTOs/ISOs able to share information with one
another to assist in implementing Know Your Customer protocols? Have
market participants indicated concerns about such information sharing
(within the RTO/ISO departments, and with other RTOs/ISOs) and if so,
how have they been addressed? Are there barriers or rules the
Commission should modify to facilitate the exchange of information
among RTOs/ISOs? If not, are there ways that information could be
shared securely and confidentially? What impact, if any, would the
sharing of additional information have on the mitigation of credit
risk? What concerns exist for the confidential treatment of information
and how could those concerns be addressed? Who is best positioned to
address those concerns?

12:30 p.m.-1:30 p.m.: Lunch
1:30 p.m.-3:00 p.m.: Panel 3: Internal Resources and Expertise within
RTOs/ISOs
    Robert Anderson, Executive Director, Committee of Chief Risk
Officers
    Melissa Brown, Senior Vice President and Chief Financial Officer,
Midcontinent ISO
    Nigeria Bloczynski, Chief Risk Officer, PJM Interconnection, LLC
    Morgan Davies, Executive Director, Alliance Risk Group
    KC Cloyd, Former VP of Commercial Credit, Exelon

    This panel will (1) address what internal resources and expertise
are needed for the RTOs/ISOs to protect their markets and market
participants from defaults, and (2) explore best practices for
efficiently building expertise on credit risk management. The panel may
include a discussion of the following topics and questions:
    1. What are key principles for the organization and governance of
risk management departments, and how should those principles be applied
to the RTOs/ISOs?
    2. Are there best practices such as minimum experience
requirements, training, or certifications that RTOs/ISOs should
consider that ensure their risk departments have sufficient staff,
training, and resources to identify and mitigate credit risks
efficiently and effectively? What are the key responsibilities of staff
and management in the risk departments of RTOs/ISOs?
    3. What data and technological systems do the RTOs/ISOs need to
manage risk? How often are the efficiency and effectiveness of these
systems assessed?
    4. How frequently should the risk departments communicate with
other departments within the RTO/ISO? Should the risk departments at
one RTO/ISO communicate with the other RTOs/ISOs? What communication
protocols are currently in place to elevate concerns regarding risk? Is
there a need for additional protocols or standards for sharing data
among the RTOs/ISOs, and if so who should be responsible for setting
those standards? Have market participants indicated concerns about such
information sharing (within the RTO/ISO departments, and with other
RTOs/ISOs) and if so, how have they been addressed?
    5. Are there any additional resources that RTOs/ISOs should obtain
or practices they should adopt to help reduce the risk of defaults?

3:00 p.m.-3:15 p.m.: Break
3:15 p.m.-4:45 p.m.: Panel 4: Impact of Market Design on Credit Risk
    Abram Klein, Managing Partner, Appian Way Energy Partners
    Keith Collins, Executive Director of Market Monitoring Unit,
Southwest Power Pool, Inc.
    Scott Everngam, President, Blue Horseshoe Energy, LLC
    Demetri Karousos, Chief Operating Officer, Nodal Exchange and Chief
Risk Officer, Nodal Clear
    Ruta Skucas, Partner, Pierce Atwood LLP

    The purpose of this panel will be to discuss how market design
impacts the credit risk in RTO/ISOs markets, particularly the FTR
markets. This panel will highlight how RTOs/ISOs and market
participants view the risk posed by different market products
(including virtuals and FTRs with different contract lengths,
locations, auction calendars, and tenors) and how this helps shape the
credit policy of the market products. This panel will also discuss how
differences between comparable market products shape credit policy
differences between the RTOs/ISOs. The panel may include a discussion
of the following topics and questions:
    1. How do differences in market design across RTOs/ISOs shape
credit risk and policies among similar market products? What role does
a market products' liquidity play in shaping the credit risk in RTO/ISO
markets?
    2. How can market design minimize credit risk? To what extent
should the consideration of potential market design changes consider
the impact of such changes on credit risk? How should the RTO/ISO
credit policies and market design strike an appropriate balance between
protecting their markets from defaults while also ensuring sufficient
competition and ease of entry?
    3. Could greater coordination with the risk department within an
RTO/ISO during the market design process help to reduce the overall
risk in the markets?
    4. What are potential benefits and drawbacks to the RTOs/ISOs and
to market participants with third party clearing of FTRs? What are the
potential benefits and drawbacks of the RTO/ISOs clearing financially
settled products using a model similar to those used by other
exchanges?

Day 2--Friday, February 26, 2021
9:00 a.m.-9:15 a.m.: Opening Remarks
9:15 a.m.-10:45 a.m.: Panel 5: Addressing Counterparty Risk: Minimum
Participation Requirements and Know Your Customer Protocols
    Andrew Stevens, Managing Director, DC Energy
    Eric Twombly, Principal, Devon Solutions LLC
    C.J. Polito, Partner, Sidley Austin LLP
    Lauren David, Director of Credit and Collateral Management, Exelon
Corporation
    Noha Sidhom, CEO, Viribus Fund LP

    This panel will address how RTOs/ISOs understand and address the
counterparty risks of market participants through minimum
capitalization requirements, creditworthiness documentation, RTO/ISO
review processes and Know Your Customer protocols. In particular, this
panel will discuss whether minimum

participation requirements create undue burdens for market
participants, and whether increased or decreased uniformity in such
requirements would be beneficial. This panel will provide an overview
of the tools available to RTOs/ISOs to conduct and proactively manage
counterparty risk, as well as best practices and opportunities for
increased efficiency. Additionally, the panel will explore
opportunities for increased information sharing across RTOs/ISOs, as
well as RTO/ISO authority and burden. The panel may include a
discussion of the following topics and questions:
    1. What is the fundamental purpose of minimum capitalization
requirements? Are the barriers to entry created by current minimum
capitalization requirements commensurate with a reduction in risk to
the RTO/ISO markets?
    2. How, if at all, should minimum capitalization differ for
different types of market participants, either based on their structure
or on the RTO/ISO markets in which they participate? How, if at all,
should minimum capitalization levels scale with the size of a market
participant's portfolio? Should a market participant's participation in
another RTO/ISO affect minimum capitalization requirements? Should
different market products have different minimum capitalization
requirements?
    3. What are current best practices for Know Your Customer
protocols? Are there tools and practices available that the RTOs/ISOs
should consider adopting? Are different practices needed for different
market products or for different types of market participants based on
type of entity, ownership structure, or business strategy? Are tools
specific to the RTOs/ISOs necessary or would commercially available,
off-the-shelf tools be adequate?
    4. What burden does the Know Your Customer process pose on market
participants? Are there ways the RTOs/ISOs could make the Know Your
Customer process more efficient without reducing its effectiveness?
    5. What level of discretion should all RTOs/ISOs have to reject or
suspend a market participant based on information discovered during
initial or periodic reviews of a market participant's risk? How should
this be balanced against market participants' rights?

10:45 a.m.-11:00 a.m.: Break
11:00 a.m.-12:30 p.m.: Panel 6: Collateral, Initial and Variation
Margining for FTR and non-FTR positions
    J.C. Kneale, Vice President for North American Natural Gas, Power,
NGL, and LNG Markets, Intercontinental Exchange Inc.
    Rafael Martinez, Senior Financial Risk Analyst, U.S. Commodity
Futures Trading Commission
    Robert Marsh, Chief Operating Officer, Monolith Energy Trading
    Kenneth Schisler, Vice President of Regulatory and Government
Affairs, CPower Energy Management
    Sam Siegel, Associate General Counsel and VP of Regulatory
Compliance for Trading and Generation, Vistra Corp
    Ryan Seghesio, Vice President, Chief Financial Officer and
Treasurer, California ISO

    The purpose of this panel will be to explore the principles
underlying initial margin (the initial amount of collateral required to
enter into a contract) and variation margin (the change in collateral
required as the value of a contract changes over time) and how RTOs/
ISOs apply these principles to the markets they administer,
particularly to FTR markets. This panel will highlight the key
differences in FTR credit practices, as well as recent changes in FTR
credit policy. The panel may include a discussion of the following
topics and questions:
    1. What are basic principles underlying initial and variation
margin and how are they applied in the RTO/ISO markets? Do current RTO/
ISO practices adhere to general principles for setting initial and
variation margin? Are there any metrics and assumptions (e.g.
collateral confidence levels and re-assessment/true-up intervals, and
position closeout assumptions) that should be examined to see how well
RTO/ISO practices ensure that initial and variation margin levels are
adequate?
    2. What are some of the best practices in terms of measuring a
market participant's FTR portfolio's anticipated exposure? What are the
potential benefits and downsides of using Mark-to-Auction collateral
requirements, incorporating future transmission changes into models, or
other methods of incorporating forward-looking price information into
FTR collateral requirements? Should all the RTOs/ISOs consider
implementing minimum collateral requirements for FTRs?
    3. How long should collateral be held by the RTOs/ISOs? Do any
RTOs/ISOs hold collateral longer than necessary or not long enough to
adequately protect their markets from the risk of market participant
defaults?
    4. Are the forms of collateral currently accepted by the RTOs/ISOs
sufficient? What are benefits and drawbacks of RTOs/ISOs accepting
surety bonds as a form of collateral? What must an RTO/ISO consider
when determining whether to accept surety bonds as a form of
collateral?

12:30 p.m.-12:45 p.m.: Closing Remarks

[FR Doc. 2021-03730 Filed 2-23-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: June 7, 2006 (Volume 71, Number 109)]
[Rules and Regulations]
[Page 32846-32849]
[DOCID:fr07jn06-19]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0056; FRL-8070-2]

Pendimethalin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues
of pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine], and its metabolite 4-[(1-ethylpropyl)amino]-2-
methyl-3,5-dinitrobenyzl alcohol in or on pistachio. Interregional
Research Project Number 4 (IR-4) requested this tolerance under the
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective June 7, 2006. Objections and
requests for hearings must be received on or before August 7, 2006, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0056. All documents in the

docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

if only availablein hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document?

     In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this ``Federal Register'' document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2005-0056 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before August 7, 2006.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2005-0056, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of March 19, 2001 (66 FR 15459) (FRL-6766-
8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
0E6083) by IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-
3390. The petition requested that 40 CFR 180.361 be amended by
establishing a tolerance for combined residues of the herbicide
pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine,
and its metabolite 4-[(1-ethylpropyl)amino-2-methyl-3,5-dinitrobenyzl
alcohol, in or on pistachio at 0.1 parts per million (ppm). That notice
included a summary of the petition prepared by FMC Corporation, the
registrant. There were no comments received in response to the notice
of filing.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this

action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure, consistent with section 408(b)(2)
of FFDCA, for a tolerance for combined residues of pendimethalin, [N-
(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], and its
metabolite 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenyzl alcohol
in or on pistachio at 0.1 ppm.
    On April 12, 2006 the Agency published a Final Rule (71 FR 18628,
FRL-7770-4) establishing tolerances for combined residues of
pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine],
and its metabolite 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenyzl
alcohol in or on almond, hulls; carrots; citrus, oil; Fruit, citrus,
group 10; Nut, tree, group 14; peppermint, oil; peppermint, tops;
spearmint, oil; and spearmint, tops. When the Agency conducted the risk
assessments in support of this tolerance action it assumed that
pendimethalin residues would be present on pistachio as well as on all
foods covered by the proposed and established tolerances. Residues on
pistachio were included because there was a pending application under
the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136
et seq., to register pendimethalin on pistachio. Therefore,
establishing the pistachio tolerance will not change the most recent
estimated aggregate risks resulting from use of pendimethalin, as
discussed in the April 12, 2006 Federal Register. Refer to the April
12, 2006 Federal Register document for a detailed discussion of the
aggregate risk assessments and determination of safety. EPA relies upon
those risk assessments and the findings made in the Federal Register
document in support of this action.
    Based on the risk assessments discussed in the final rule published
in the Federal Register of April 12, 2006, EPA concludes that there is
a reasonable certainty that no harm will result to the general
population, and to infants and children from aggregate exposure to
pendimethalin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate methods are available for data collection and tolerance
enforcement for existing and proposed uses of pendimethalin. Methods I
through IV in the Pesticide Analytical Manuel (PAM) Vol. II are gas
chromatography/electron capture (GC/ECD) methods. Methods used for data
collection are essentially the same as the PAM Vol. II methods, and
have been adequately validated.
    The Food and Drug Administrations's PESTDATA data base (PAM Volume
I, Appendix I) indicates that pendimethalin is completely recovered
(< 80%) by Multiresidue Methods Section 302 (Luke method; Protocol D)
and 303 (Mills, Onley, Gaither method; Protocol E, nonfatty), and
partially recovered (50-80%) by Multiresidue Method Section 304 (Mills
fatty food method; Protocol E, fatty).
    The method maybe requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

B. International Residue Limits

    There are no established or proposed Codex Maximum Residue Levels
(MRLs) for pendimethalin residues. Therefore, there are no issues of
compatibility with respect to Codex MRLs and U.S. tolerances.

V. Conclusion

    Therefore, the tolerance is established for combined residues of
pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine],
and its metabolite 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenyzl
alcohol in or on pistachio at 0.1 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations

that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: May 24, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.361 is amended by alphabetically adding a commodity to
the table in paragraph (a) to read as follows:

Sec.  180.361   Pendimethalin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
Commodity            Parts per million
------------------------------------------------
                                * * * * *
Pistachio  0.1
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E6-8830 Filed 6-6-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 76, Number 233 (Monday, December 5, 2011)]
[Rules and Regulations]
[Pages 75772-75774]
[FR Doc No: 2011-30939]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0448; Directorate Identifier 2007-SW-51-AD;
Amendment 39-16841; AD 2011-21-18]
RIN 2120-AA64

Airworthiness Directives; Eurocopter France Model EC 120B
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This amendment adopts a new airworthiness directive (AD) for
the Eurocopter France Model EC 120B helicopters. This AD requires
modifying the pilot cyclic control friction device by replacing a
certain thrust washer with two thrust washers. This AD is prompted by
an incident in which the pilot encountered a sudden restriction of the
cyclic control movement during flight. The actions specified by this AD
are intended to prevent jamming of a pilot cyclic control stick and
subsequent loss of control of the helicopter.

DATES: Effective December 20, 2011.

ADDRESSES: You may get the service information identified in this AD
from American Eurocopter Corporation, 2701 Forum Drive, Grand Prairie,
Texas 75053-4005, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.
    Examining the Docket: You may examine the docket that contains this
AD, any comments, and other information on the Internet at http://www.regulations.gov or at the Docket Operations office, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Gary Roach, Aviation Safety Engineer,
Regulations and Policy Group, Rotorcraft Directorate, FAA, 2601 Meacham
Blvd., Fort Worth, Texas 76137, telephone<PHONE_NUMBER>, fax (817)
222-5961.

SUPPLEMENTARY INFORMATION:

Discussion

    On April 27, 2011, we issued a Notice of Proposed Rulemaking (NPRM)
to amend 14 CFR part 39 to include an AD that would apply to Eurocopter
France Model EC 120B helicopters. That NPRM was published in the
Federal Register on May 13, 2011 (76 FR 27952). That NPRM proposed to
modify the pilot cyclic control friction device by replacing a certain
thrust washer with two thrust washers. The proposed AD was prompted by
an incident in which the pilot encountered a sudden restriction of the
cyclic control movement during flight.
    The Direction Generale de l'Aviation Civile France (DGAC), which is
the aviation authority for France, has issued French AD No. F-2005-175,
dated October 26, 2005, on behalf of the European Aviation Safety
Agency (EASA), the Airworthiness Authority of the State of Design for
the affected helicopters, to correct an unsafe condition for the
Eurocopter France Model EC 120B helicopters.

Related Service Information

    Eurocopter has issued Alert Service Bulletin No. 67A011, Revision
1, dated October 24, 2005 (ASB), which specifies a modification to
preclude the risk that the pilot cyclic control stick will jam. The
modification consists of replacing the existing single-piece thrust
washer, part number (P/N) C671A1006201, with two thrust washers, P/N
C671A1018201 and P/N C671A1019201. The DGAC classified this alert
service bulletin as mandatory and issued AD No. F-2005-175, dated
October 26, 2005, to ensure the continued airworthiness of these
helicopters.

FAA's Evaluation and Unsafe Condition Determination

    This product has been approved by the aviation authority of France
and is approved for operation in the United States. Pursuant to our
bilateral agreement with France, the DGAC, on behalf of the EASA, their
technical representative, has notified us of the unsafe condition
described in the DGAC AD. We are issuing this AD because we evaluated
all information provided by the DGAC and determined the unsafe
condition exists and is likely to exist or develop on other products of
the same type design. This AD requires replacing a single-piece thrust
washer, P/N C671A1006201, with two thrust washers, P/N C671A1018201 and
P/N C671A1019201, to prevent the jamming of the pilot cyclic control
stick.

Differences Between This AD and the DGAC AD

    The DGAC AD requires compliance with the ASB no later than December
31, 2005. Our AD requires compliance within 30 days after the effective
date of the AD.

Comments

    By publishing the NPRM (76 FR 27952, May 13, 2011), we gave the
public an opportunity to participate in developing this AD. However, we
received no comment on the NPRM or on our determination of the cost to
the public. Therefore, based on our review and evaluation of the
available data, we have determined that air safety and the public
interest require adopting the AD as proposed.

Costs of Compliance

    We estimate that this AD affects 114 helicopters of U.S. registry
and the required actions will take approximately 3 work hours per
helicopter to accomplish at an average labor rate of $85 per work hour.
Required parts cost approximately $50 per helicopter. Based on these
figures, we estimate the total cost impact of this AD on U.S. operators
to be $34,770 for the entire fleet, or $305 per helicopter, to replace
the single thrust washer with two thrust washers.

Regulatory Findings

    We have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect on the States, on the relationship between
the national Government and the States, or on the distribution of power
and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that the regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act. We prepared an economic evaluation
of the estimated costs to comply with this AD. See the AD docket to
examine the economic evaluation.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
subtitle VII, part A, subpart III, section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration amends part 39 of
the Federal Aviation Regulations (14 CFR part 39) as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

     Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. Section 39.13 is amended by adding a new airworthiness directive to
read as follows:

2011-21-18 Eurocopter France: Amendment 39-16841; Docket No. FAA-
2011-0448; Directorate Identifier 2007-SW-51-AD.

    Applicability: Model EC 120B helicopters, serial numbers up to
and including 1385, with a thrust washer, part number (P/N)
C671A1006201, installed on the pilot cyclic control stick friction
device; and a pilot cyclic stick, P/N C671A1007101, P/N
C671A1007102, or C671A1003102, installed, certificated in any
category.
    Compliance: Required within 30 days, unless accomplished
previously.
    To prevent jamming of a pilot cyclic control stick and
subsequent loss of control of the helicopter, accomplish the
following:
    (a) Remove the pilot cyclic control stick; replace the thrust
washer, P/N C671A1006201, with two thrust washers, P/N C671A1018201
and P/N C671A1019201; reinstall the pilot cyclic control stick; and
perform a functional test of the cyclic control.
    (b) To request a different method of compliance or a different
compliance time

for this AD, follow the procedures in 14 CFR 39.19. Contact the
Manager, Safety Management Group, Rotorcraft Directorate, FAA, ATTN:
Gary Roach, Aviation Safety Engineer, Regulations and Policy Group,
ASW-111, 2601 Meacham Blvd., Fort Worth, Texas 76137, telephone
(817) 222-5130, fax<PHONE_NUMBER>, for information about previously
approved alternative methods of compliance.
    (c) The Joint Aircraft System/Component (JASC) Code is 2700:
Flight Control System.
    (d) This amendment becomes effective on December 20, 2011.

    Note:  The subject of this AD is addressed in Direction Generale
de l'Aviation Civile (France) AD No. F-2005-175, dated October 26,
2005, and Eurocopter Alert Service Bulletin No. 67A011, Revision 1,
dated October 24, 2005.

    Issued in Fort Worth, Texas, on October 5, 2011.
Kim Smith,
Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2011-30939 Filed 12-2-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 206 (Thursday, October 24, 2019)]
[Notices]
[Pages 57030-57034]
[FR Doc No: 2019-23204]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0825]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Premarket Approval of Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on requirements for premarket approval of
medical devices.

DATES: Submit either electronic or written comments on the collection
of information by December 23, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 23, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 23, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0825 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Premarket Approval of Medical
Devices.'' 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.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, 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: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Premarket Approval of Medical Devices

OMB Control Number 0910-0231--Extension

    Under section 515 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360e) all devices placed into class III by FDA are
subject to

premarket approval application (PMA) requirements. PMA is the process
of scientific and regulatory review to ensure the safety and
effectiveness of class III devices. An approved PMA is, in effect, a
private license granted to the applicant for marketing a particular
medical device. A class III device that fails to meet PMA requirements
is considered to be adulterated under section 501(f) of the FD&C Act
(21 U.S.C. 351(f)) and cannot be marketed. PMA requirements apply
differently to preamendments devices, postamendments devices, and
transitional class III devices.
    Manufacturers of class III preamendments devices (devices that were
in commercial distribution before May 28, 1976) are not required to
submit a PMA until 30 months after the issuance of a final
classification regulation or until 90 days after the publication of a
final regulation requiring the submission of a PMA, whichever period is
later. FDA may allow more than 90 days after issuance of a final rule
for submission of a PMA.
    A postamendments device is one that was first distributed
commercially on or after May 28, 1976. Postamendments devices
determined by FDA to be substantially equivalent to preamendments class
III devices are subject to the same requirements as the preamendments
devices. FDA determines substantial equivalence after reviewing an
applicant's premarket notification submitted in accordance with section
510(k) of the FD&C Act (21 U.S.C. 360(k)). Postamendments devices
determined by FDA to be not substantially equivalent to either
preamendments devices or postamendments devices classified into class I
or II are ``new'' devices and fall automatically into class III. Before
such devices can be marketed, they must have an approved PMA or be must
reclassified into class I or class II.
    The Food and Drug Administration Modernization Act of 1997 (FDAMA)
(Pub. L. 105-115) amended the FD&C Act by streamlining the process of
bringing safe and effective drugs, medical devices, and other therapies
to the U.S. market. FDAMA added section 515(d)(6) to the FD&C Act,
which provided that PMA supplements were required for all device
changes that affect safety and effectiveness unless such changes are
modifications to manufacturing procedures or method of manufacture.
That type of manufacturing change requires a 30-day notice, or where
FDA finds such notice inadequate, a 135-day PMA supplement.
    The implementing regulations, contained in 21 CFR part 814, further
specify the contents of a PMA for a medical device and the criteria FDA
will employ in approving, denying, or withdrawing approval of a PMA and
supplements to PMAs. The regulations' purpose is to establish an
efficient and thorough procedure for FDA's review of PMAs and
supplements to PMAs for class III medical devices. The regulations
facilitate the approval of PMAs and supplements to PMAs for devices
that have been shown to be reasonably safe and effective and otherwise
meet the statutory criteria for approval. The regulations also allow
for the denial of PMAs and supplements to PMAs for devices that have
not been shown to be reasonably safe and effective and that do not
otherwise meet the statutory criteria for approval.
    The burden estimate is based on the annual rate of receipt of PMA
submissions for fiscal years (FYs) 2016 through 2018 and our
expectation of submissions to come in the next few years. The burden
data for PMAs is based on data provided by applicants by device type
and cost element in an earlier study.

Reporting Burden

    Section 814.15(b) (21 CFR 814.15(b))--Research Conducted Outside
the United States. FDA will accept information on a clinical
investigation conducted outside the United States (OUS) to support a
PMA if the investigation is well-designed and well-conducted and
certain other conditions are met, including that the investigation was
conducted in accordance with good clinical practice (GCP) as specified
in 21 CFR 812.28. If the OUS clinical investigation did not conform to
GCP, then the PMA submission should include a waiver request or a
statement explaining the reason for not conducting the investigation in
accordance with GCP and a description of steps taken to ensure that the
data and results are credible and accurate and that the rights, safety,
and well-being of subjects have been adequately protected. Based on the
number of PMAs received that contained studies from overseas, FDA
estimates that the burden estimate necessary to meet this requirement
is 50 hours.
    Section 814.20 (21 CFR 814.20)--Application. Specifies the
information required in a PMA and update reports such as the
applicant's name and address, a description of the device, its
labeling, its indications for use, and summary of clinical and non-
clinical studies. Included in this requirement is the conduct of
laboratory and clinical trials, as well as the analysis, review, and
physical preparation of the PMA application. FDA estimates that 38
applicants, including hospital remanufacturers of single-use devices,
will be affected by these requirements, which are based on the actual
average of FDA receipt of new PMA applications in FYs 2016 through
2018.
    Additionally, the ``Human Subject Protection; Acceptance of Data
from Clinical Investigations for Medical Devices'' final rule (83 FR
7366; February 21, 2018) amended this section to address requirements
for a PMA supported by data from clinical investigations conducted
outside the United States. The applicant will be required to submit the
information as described in Sec.  814.20(b)(6)(ii)(C). We estimate this
will take 30 minutes per respondent. We estimate that 10 respondents
annually will submit such information.
    The collections in OMB control number 0910-0741, ``Human Subject
Protection; Acceptance of Data from Clinical Studies for Medical
Devices,'' were submitted to OMB as a new information collection
request with the expectation that the currently approved requirements
will be amended. As noted in the Supporting Statement for OMB control
number 0910-0741, we are amending OMB control number 0910-0231 to
reflect the information collections associated with the rulemaking
under Sec.  814.20(b)(6)(ii)(C).
    Section 814.37(a) through (c) and (e) (21 814.37(a) through (c) and
(e))--PMA Amendments and Resubmitted PMAs. As part of the review
process, FDA often requests the PMA applicant to submit additional
information regarding the device necessary for FDA to file the PMA or
to complete its review and make a final decision. The PMA applicant
may, on their own initiative, submit additional information to FDA
during the review process. These amendments contain information ranging
from additional test results and reanalysis of the original data set to
revised device labeling. Almost all PMAs received by the Agency have
amendments submitted during the review process.
    Section 814.39(a) (21 CFR 814.39(a))--PMA Supplements. This
information collection includes the requirements for the range of PMA
supplements (panel track, 180-day fee-based, 180-day non-fee-based, and
real-time supplements).
    Section 814.39(d)--Special PMA Supplements--Changes Being Affected.
This type of supplement is intended to enhance the safety of the device
or the safe use of the device. The number of PMA supplements received
that fit this

category averaged 75 per year based on the numbers received from FYs
2016 through 2018.
    Section 814.39(f)--30-Day Notice. Under section 515(d) of the FD&C
Act, modifications to manufacturing procedures or methods of
manufacture that affect the safety and effectiveness of a device
subject to an approved PMA do not require submission of a PMA
supplement under paragraph (a) of that section and are eligible to be
the subject of a 30-day notice. A 30-day notice shall describe in
detail the change, summarize the data or information supporting the
change, and state that the change has been made in accordance with the
requirements of part 820 (21 CFR part 820). The applicant may
distribute the device 30 days after the date on which FDA receives the
30-day notice, unless FDA notifies the applicant within 30 days from
receipt of the notice that it is not adequate.
    Section 814.82(a)(9) (21 CFR 814.82(a)(9))--Postapproval
Requirements. Postapproval requirements concerns approved PMAs that
were not reclassified and require a periodic report. After approval,
all PMAs require a submission of an annual report. A majority of the
submitted PMAs require associated postapproval studies, i.e., followup
of patients used in clinical trials to support the PMA or additional
preclinical information that is labor-intensive to compile and
complete; the remaining PMAs require minimal information.
    Section 814.84(b) (21 CFR 814.84(b))--Periodic Reports.
Postapproval requirements described in Sec.  814.82(a)(7) require
submission of an annual report for each approved PMA. FDA estimates
that respondents will average about 10 hours in preparing their reports
to meet this requirement. This estimate is based on FDA's experience
and consultation with industry.
    The Breakthrough Devices Program--The Breakthrough Devices Program
supersedes the Expedited Access Pathway and Priority Review for medical
devices. The guidance document ``Breakthrough Devices Program''
implements section 515B of the FD&C Act (21 U.S.C. 360e-3), as created
by section 3051 of the 21st Century Cures Act (Pub. L. 114-255) and
amended by section 901 of the FDA Reauthorization Act of 2017 (Pub. L.
115-52). The Breakthrough Devices Program is a voluntary program for
certain medical devices and device-led combination products that
provide for more effective treatment or diagnosis of life-threatening
or irreversibly debilitating diseases or conditions. The program is
intended to help patients have more timely access to these medical
devices by expediting their development, assessment, and review, while
preserving the statutory standards for premarket approval, 510(k)
clearance, and De Novo marketing authorization, consistent with the
Agency's mission to protect and promote public health.
    Agreement Meeting--Section 520(g)(7) of the FD&C Act (21 U.S.C.
360j(g)(7)). Applicants planning to submit a PMA may submit a written
request to reach agreement with FDA on the key parameters of the
investigational plan.
    Determination Meeting--Section 513(a)(3)(D) of the FD&C Act (21
U.S.C. 360c(a)(3)(D)). Applicants planning to submit a PMA may submit a
written request to FDA for a meeting to determine the type of
information (valid scientific evidence) necessary to support the
effectiveness of their device.
    Panel of Experts--Section 515(c)(3) of the FD&C Act. An original
PMA or panel track PMA supplement is taken to an advisory panel of
experts unless FDA determines that the information in the application
substantially duplicates information that has previously been reviewed
by the panel.
    Day 100 Meeting--Section 515(d)(3) of the FD&C Act. FDA must, upon
the written request of the applicant, meet with that party within 100
days of receipt of the filed PMA application to discuss the review
status of the application. With the concurrence of the applicant, a
different schedule may be established. Prior to this meeting, FDA must
inform the applicant in writing of any identified deficiencies and what
information is required to correct those deficiencies. FDA must also
promptly notify the applicant if FDA identifies additional deficiencies
or of any additional information required to complete Agency review.

Recordkeeping

    Section 814.82(a)(5) and (6)--Maintenance of Records. The
recordkeeping burden under this section requires the maintenance of
records used to trace patients, and the organization and indexing of
records into identifiable files to ensure the device's continued safety
and effectiveness. These records are required of all applicants who
have an approved PMA.
    PMAs have been required since 1976, and there are 801 active PMAs
that could be subject to these requirements, based on actual FDA data,
and approximately 39 new PMAs are approved every year. The aggregate
burden for the estimated 446 PMA holders of approved original PMAs for
the next few years is estimated to be 7,582 hours.
    The applicant determines which records should be maintained during
product development to document and/or substantiate the device's safety
and effectiveness. Records required by the current good manufacturing
practices for medical devices regulation (part 820) may be relevant to
a PMA review and may be submitted as part of an application. In
individual instances, records may be required as conditions of approval
to ensure the device's continuing safety and effectiveness.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
   Activity/21 CFR or FD&C Act       Number of     responses per    Total annual    burden per      Total hours
             Section                respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Research conducted outside the                25               1              25               2              50
 United States (814.15(b))......
PMA application (814.20)........              46               1              46             668          30,728
Information on clinical                       10               1              10             0.5               5
 investigations conducted
 outside the United States
 (814.20(b)(6)(ii)(C))..........
PMA amendments and resubmitted             1,528               1           1,528             167         255,176
 PMAs (814.37(a)-(c) and (e))...
PMA supplements (814.39(a)).....             777               1             777              60          46,620
Special PMA supplement--changes               75               1              75               6             450
 being effected (814.39(d)).....
30-day notice (814.39(f)).......           1,722               1           1,722              16          27,552
Postapproval requirements                    121               1             121             135          16,335
 (814.82(a)(9)).................

Periodic reports (814.84(b))....             764               1             764              10           7,640
Breakthrough Devices Program                  11               1              11              10             110
 (515(B) of the FD&C Act).......
Agreement meeting (520(g)(7) of                1               1               1              50              50
 the FD&C Act)..................
Determination Meeting                          1               1               1              50              50
 (513(a)(3)(D) of the FD&C Act).
Panel meeting (515(c)(3) of the                1               1               1              30              30
 FD&C Act)......................
Day 100 meeting (515(d)(3) of                 14               1              14              10             140
 the FD&C Act)..................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         384,936
----------------------------------------------------------------------------------------------------------------
\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
                      Activity/21 CFR section                           Number of       records per      Total annual         per          Total Hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of records (814.82(a)(5) and (6))......................             446                1              446               17            7,582
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We made the following changes to the information collection:
     Added the burden estimate for ``Information on clinical
investigations conducted outside the United States
(814.20(b)(6)(ii)(C)),'' which is associated with the ``Human Subject
Protection; Acceptance of Data from Clinical Investigations for Medical
Devices'' final rule as described previously in this document.
     Revised the burden description and table to reflect that
the Expedited Access Pathway and Priority Review have been superseded
by the Breakthrough Devices Program.
     Updated our burden estimate with FYs 2016 to 2018 data.
    These adjustments resulted in an overall increase of 34,782 hours
to the estimated burden.

    Dated: October 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23204 Filed 10-23-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 159 (Friday, August 16, 2019)]
[Notices]
[Pages 42000-42002]
[FR Doc No: 2019-17579]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2019-0002; Internal Agency Docket No. FEMA-B-1954]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Federal
Regulations. The LOMR will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings. For rating purposes, the currently
effective community number is shown in the table below and must be used
for all new policies and renewals.

DATES: These flood hazard determinations will be finalized on the dates
listed in the table below and revise the FIRM panels and FIS report in
effect prior to this determination for the listed communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Insurance and Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the National Flood Insurance Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR

60.3, are the minimum that are required. They should not be construed
to mean that the community must change any existing ordinances that are
more stringent in their floodplain management requirements. The
community may at any time enact stricter requirements of its own or
pursuant to policies established by other Federal, State, or regional
entities. The flood hazard determinations are in accordance with 44 CFR
65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    Chief executive                       Online location of
       State and county         Location and case      officer of       Community map        letter of map         Date of modification       Community
                                       No.             community          repository           revision                                          No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Colorado:
    Adams.....................  City of Thornton,  The Honorable      City Hall, 12450   https://msc.fema.gov/ Nov. 29, 2019...............       080007
                                 (18-08-1051P).     Heidi Williams,    Washington         portal/
                                                    Mayor, City of     Street,            advanceSearch.
                                                    Thornton, 9500     Thornton, CO
                                                    Civic Center       80241.
                                                    Drive, Thornton,
                                                    CO 80229.
Jefferson.....................  City of            The Honorable      City Hall, 4800    https://msc.fema.gov/ Nov. 29, 2019...............       080008
                                 Westminster, (18-  Herb Atchison,     West 92nd          portal/
                                 08-1051P).         Mayor, City of     Avenue,            advanceSearch.
                                                    Westminster,       Westminster, CO
                                                    4800 West 92nd     80031.
                                                    Avenue,
                                                    Westminster, CO
                                                    80031.
Florida:
    Hendry....................  Unincorporated     The Honorable      Hendry County      https://msc.fema.gov/ Nov. 22, 2019...............       120107
                                 areas of Hendry    Mitchell Wills,    Engineering        portal/
                                 County, (18-04-    Chairman, Hendry   Department, 99     advanceSearch.
                                 7584P).            County Board of    East Cowboy Way,
                                                    Commissioners,     LaBelle, FL
                                                    P.O. Box 1760,     33935.
                                                    LaBelle, FL
                                                    33975.
    Lee.......................  Unincorporated     The Honorable      Lee County         https://msc.fema.gov/ Nov. 22, 2019...............       125124
                                 areas of Lee       Roger              Department of      portal/
                                 County, (18-04-    Desjarlais, Lee    Community          advanceSearch.
                                 7584P).            County Manager,    Development,
                                                    P.O. Box 398,      1500 Monroe
                                                    Fort Myers, FL     Street, Fort
                                                    33902.             Myers, FL 33901.
Georgia:
    DeKalb....................  City of Dunwoody,  The Honorable      Community          https://msc.fema.gov/ Nov. 22, 2019...............       130679
                                 (18-04-6945P).     Denis Shortal,     Development        portal/
                                                    Mayor, City of     Department, 4800   advanceSearch.
                                                    Dunwoody, 4800     Ashford Dunwoody
                                                    Ashford Dunwoody   Road, Dunwoody,
                                                    Road, Dunwoody,    GA 30338.
                                                    GA 30338.
    Fulton....................  City of Sandy      The Honorable      Community          https://msc.fema.gov/ Nov. 22, 2019...............       130669
                                 Springs, (18-04-   Rusty Paul,        Development        portal/
                                 6945P).            Mayor, City of     Department, 1      advanceSearch.
                                                    Sandy Springs, 1   Galambos Way,
                                                    Galambos Way,      Sandy Springs,
                                                    Sandy Springs,     GA 30328.
                                                    GA 30328.
Maryland:
    Frederick.................  City of            The Honorable      Public Works,      https://msc.fema.gov/ Nov. 19, 2019...............       240030
                                 Frederick, (19-    Michael            Engineering        portal/
                                 03-0460P).         O'Connor, Mayor,   Department, 140    advanceSearch.
                                                    City of            West Patrick
                                                    Frederick, 101     Street,
                                                    North Court        Frederick, MD
                                                    Street,            21701.
                                                    Frederick, MD
                                                    21701.
    Frederick.................  Unincorporated     The Honorable Jan  Frederick County   https://msc.fema.gov/ Nov. 19, 2019...............       240027
                                 areas of           H. Gardner,        Department of      portal/
                                 Frederick          Frederick County   Development        advanceSearch.
                                 County, (19-03-    Executive, 12      Review, Zoning
                                 0460P).            East Church        Administration,
                                                    Street,            30 North Market
                                                    Frederick, MD      Street,
                                                    21701.             Frederick, MD
                                                                       21701.
Oklahoma:
    Bryan.....................  Town of Calera,    The Honorable      Town Hall, 110     https://msc.fema.gov/ Nov. 25, 2019...............       400354
                                 (19-06-0163P).     Brenton Rucker,    West Main          portal/
                                                    Mayor, Town of     Street, Calera,    advanceSearch.
                                                    Calera, 110 West   OK 74730.
                                                    Main Street,
                                                    Calera, OK 74730.
Texas:
    Bastrop...................  City of Bastrop    The Honorable      City Hall, 1311    https://msc.fema.gov/ Nov. 18, 2019...............       480022
                                 (19-06-0976P).     Connie             Chestnut Street,   portal/
                                                    Schroeder,         Bastrop, TX        advanceSearch.
                                                    Mayor, City of     78602.
                                                    Bastrop, P.O.
                                                    Box 427,
                                                    Bastrop, TX
                                                    78602.
    Bastrop...................  Unincorporated     The Honorable      Bastrop County     https://msc.fema.gov/ Nov. 18, 2019...............       481193
                                 areas of Bastrop   Paul Pape          Engineering and    portal/
                                 County, (19-06-    Bastrop County     Development        advanceSearch.
                                 0976P).            Judge, 804 Pecan   Department, 211
                                                    Street, Bastrop,   Jackson Street,
                                                    TX 78602.          Bastrop, TX
                                                                       78602.

    Tarrant...................  City of Keller     The Honorable Pat  Public Works       https://msc.fema.gov/ Oct. 24, 2019...............       480602
                                 (19-06-1585P).     McGrail, Mayor,    Department, 1100   portal/
                                                    City of Keller,    Bear Creek         advanceSearch.
                                                    P.O. Box 770,      Parkway, Keller,
                                                    Keller, TX 76244.  TX 76248.
    Tarrant...................  City of            The Honorable      Department of      https://msc.fema.gov/ Nov. 29, 2019...............       480606
                                 Mansfield, (19-    David L. Cook,     Zoning and         portal/
                                 06-0853P).         Mayor, City of     Planning, 1200     advanceSearch.
                                                    Mansfield, 1200    East Broad
                                                    East Broad         Street,
                                                    Street,            Mansfield, TX
                                                    Mansfield, TX      76063.
                                                    76063.
    Travis....................  City of Manor,     Mr. Thomas M.      City Hall, 105     https://msc.fema.gov/ Dec. 2, 2019................       481027
                                 (19-06-0958P).     Bolt, Manager,     East Eggleston     portal/
                                                    City of Manor,     Street, Manor,     advanceSearch.
                                                    P.O. Box 387,      TX 78653.
                                                    Manor, TX 78653.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2019-17579 Filed 8-15-19; 8:45 am]
 BILLING CODE 9110-12-P


[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Page 10141]
[FR Doc No: 2021-03214]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91109; File No. SR-NASDAQ-2020-090]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Order
Approving a Proposed Rule Change To Amend the Exchange's Rules at
Equity 4, Section 4703(h) Relating to Reserve Orders

February 11, 2021.

I. Introduction

    On December 15, 2020, The Nasdaq Stock Market LLC (``Exchange'' or
``Nasdaq'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend the Exchange's rules at Equity 4, Section
4703(h) relating to orders with the reserve size order attribute. The
proposed rule change was published for comment in the Federal Register
on December 30, 2020.\3\ The Commission has received no comments on the
proposed rule change. This order approves the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 90793 (December 23,
2020), 85 FR 86598 (``Notice'').
---------------------------------------------------------------------------

II. Description of the Proposal

    Pursuant to Equity 4, Section 4703(h) of the Exchange's rules,
reserve size is an order attribute that permits a participant to
stipulate that an order type that is displayed may have its displayed
size replenished from additional non-displayed size. When a participant
enters an order with reserve size (``Reserve Order''), the full size of
the order will be presented for potential execution in compliance with
Regulation NMS and thereafter, unexecuted portions of the order will be
processed as a displayed order and a non-displayed order.\4\ When a
Reserve Order is posted, if there is an execution against the displayed
order that causes its size to decrease below a normal unit of trading,
a new displayed order will be entered and receive a new timestamp,
while the size of the non-displayed order will be reduced by the same
amount and will not receive a new timestamp.\5\
---------------------------------------------------------------------------

    \4\ See Exchange Equity 4, Section 4703(h). See also Securities
Exchange Act Release No. 90389 (November 10, 2020), 85 FR 73304
(November 17, 2020) (amending Exchange Equity 4, Section 4703(h)
relating to Reserve Orders).
    \5\ See Exchange Equity 4, Section 4703(h).
---------------------------------------------------------------------------

    The Exchange proposes to amend Equity 4, Section 4703(h) to provide
that, if the new displayed order would lock an order that posted to the
Nasdaq book before replenishment can occur, the displayed order would
post at the locking price if the resting order is non-displayed,\6\ or
would be repriced, ranked, and displayed at one minimum price increment
lower (higher) than the locking price if the resting order to sell
(buy) is displayed. The proposed functionality would also apply to a
Reserve Order that does not execute fully upon initial order entry, if
the displayed order portion of the Reserve Order would lock a resting
order upon entry.\7\
---------------------------------------------------------------------------

    \6\ The Exchange states that, if the new displayed order posts
to the Nasdaq book and locks a resting non-displayed order with the
Trade Now order attribute enabled, then consistent with the
definition of Trade Now, the Trade Now functionality would apply and
the non-displayed order would be able to execute against the locking
displayed order as a liquidity taker. See Notice, supra note 3, at
86598-99 n.7. If a locked non-displayed order does not have the
Trade Now order attribute enabled, then new incoming orders would be
eligible to execute against the displayed order. See id. See also
Exchange Equity 4, Section 4703(m) (describing the Trade Now order
attribute).
    \7\ See Notice, supra note 3, at 86598 n.6. The Exchange also
proposes to correct a non-substantive typographical error in
Exchange Equity 4, Section 4703(h).
---------------------------------------------------------------------------

    According to the Exchange, it established the Reserve Order with
the intention that the order would always act as a provider of
liquidity upon replenishment, and this is what Exchange participants
have come to expect from the operation of Reserve Orders.\8\ The
Exchange states that the proposal would eliminate any ambiguity under
its existing rules as to whether a Reserve Order would take liquidity
when a locking order posts to the Nasdaq book prior to the Reserve
Order completing its replenishment (or prior to the displayed order
portion of the Reserve Order posting to the Nasdaq book for the first
time).\9\
---------------------------------------------------------------------------

    \8\ See id. at 86598.
    \9\ See id. at 86599. The Exchange also states that a rule
filing from 2016 introduced a rare circumstance where a Reserve
Order, upon replenishment of its displayed order portion,
theoretically could become a liquidity remover under existing
Exchange rules. See id. at 86598-89.
---------------------------------------------------------------------------

III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities
exchange.\10\ In particular, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\11\ which
requires, among other things, that the rules of a national securities
exchange be designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \10\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    As discussed above, the proposed rule change is designed to provide
that a Reserve Order, after posting on the Nasdaq book, would always
act as a liquidity provider upon replenishment of its displayed order
portion. The Commission believes that the proposed rule change is
reasonably designed to ensure that a Reserve Order would operate
similarly during race conditions (i.e., when a locking order posts to
the Nasdaq book prior to the Reserve Order completing its
replenishment, or prior to the displayed order portion of the Reserve
Order posting to the Nasdaq book for the first time) as it would during
non-race conditions. The Commission also believes that the proposed
rule change would provide the users of Reserve Orders greater certainty
and transparency about how the Exchange processes these orders.\12\
---------------------------------------------------------------------------

    \12\ The Commission also believes that the correction of the
non-substantive typographical error in Exchange Equity 4, Section
4703(h) would improve the readability and clarity of that rule.
---------------------------------------------------------------------------

    Based on the foregoing, the Commission finds that the proposed rule
change is consistent with the Act.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\13\ that the proposed rule change (SR-NASDAQ-2020-090) be, and
hereby is, approved.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-03214 Filed 2-17-21; 8:45 am]
BILLING CODE 8011-01-P