[Federal Register Volume 82, Number 24 (Tuesday, February 7, 2017)]
[Notices]
[Pages 9583-9584]
[FR Doc No: 2017-02520]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4296-DR; Docket ID FEMA-2017-0001]

Oregon; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Oregon (FEMA-4296-DR), dated January 25,
2017, and related determinations.

DATES: Effective January 25, 2017.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated January 25, 2017, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage in certain areas of the State
of Oregon resulting from a severe winter storm and flooding during
the period of December 14-17, 2016, is of sufficient severity and
magnitude to warrant a major disaster declaration under the Robert
T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121 et seq. (the ``Stafford Act''). Therefore, I declare that such
a major disaster exists in the State of Oregon.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, with the

exception of projects that meet the eligibility criteria for a
higher Federal cost-sharing percentage under the Public Assistance
Alternative Procedures Pilot Program for Debris Removal implemented
pursuant to section 428 of the Stafford Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Dolph A. Diemont, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Oregon have been designated as
adversely affected by this major disaster:

    Josephine and Lane Counties for Public Assistance.
    All areas within the State of Oregon are eligible for assistance
under the Hazard Mitigation Grant Program.

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

Robert J. Fenton,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-02520 Filed 2-6-17; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register: December 29, 2005 (Volume 70, Number 249)]
[Rules and Regulations]
[Page 77048-77052]
[DOCID:fr29de05-7]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[FRL-8016-7]
RIN 2060-AM56

Protection of Stratospheric Ozone: Extension of Global Laboratory
and Analytical Use Exemption for Essential Class I Ozone Depleting
Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is taking final action to extend the global laboratory and
analytical use exemption for production and import of class I ozone-
depleting substances from December 31, 2005, to December 31, 2007,
consistent with recent actions by the Parties to the Montreal Protocol
on Substances that Deplete the Ozone Layer. The exemption allows
persons in the United States to produce and import controlled
substances for laboratory and analytical uses that have not been
already identified by EPA as nonessential.

EFFECTIVE DATE: This final rule is effective on January 1, 2006.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. OAR-2004-0064. All documents in the docket are listed in the
EDOCKET index at http://www.epa.gov/edocket. Although listed in the

index, some information is not publicly available, i.e., 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 either electronically in
EDOCKET or in hard copy at the Air Docket, EPA/DC, EPA West, Room B102,
1301 Constitution Ave., NW., Washington, DC. This Docket Facility is
open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the Air Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Hodayah Finman, U.S. Environmental
Protection Agency, Office of Air and Radiation, Stratospheric
Protection Division (6205J), 1200 Pennsylvania Avenue, NW., Washington,
DC 20460; telephone number:<PHONE_NUMBER>; fax numbers: (202) 343-
2338<EMAIL_ADDRESS>You may also visit the EPA's Ozone
Depletion Web site at http://www.epa.gov/ozone for further information about

EPA's Stratospheric Ozone Protection regulations, the science of ozone
layer depletion, and other related topics.

SUPPLEMENTARY INFORMATION: This final rule concerns the exemption for
laboratory and analytical uses from CAA restrictions on the consumption
and production of class I controlled substances. In May 2005, EPA
proposed extending this exemption program from December 31, 2005, to
December 31, 2007, consistent with action taken by the Parties to the
Montreal Protocol (70 FR 25726, May 13, 2005). Today's action finalizes
the proposed extension. In addition, the Agency solicited comment on
clarifying the status of methyl bromide, a class I controlled
substance, under the laboratory and analytical use exemption program.
EPA is deferring final action on that aspect of the proposed rule.
    Section 553(d) of the Administrative Procedure Act (APA), 5 U.S.C.,
Chapter 5, generally provides that rules may not take effect earlier
than 30 days after they are published in the Federal Register. Today's
final rule is issued under section 307(d) of the CAA, which states:
``The provisions of section 553 through 557 * * * of Title 5 shall not,
except as expressly provided in this subsection, apply to actions to
which this subsection applies.'' CAA section 307(d)(1). Thus, section
553(d) of the APA does not apply to this rule. EPA nevertheless is
acting consistently with the policies underlying APA section 553(d) in
making this rule effective on January 1, 2006 APA section 553(d)
provides an exception for any action that grants or recognizes an
exemption or relieves a restriction. Today's final rule extends an
exemption from the phaseout of class I ozone-depleting substances.
Because the current exemption expires at the end of 2005, EPA is making
this rule effective immediately to ensure that the exemption will not
lapse.

Table of Contents

I. Background on the Montreal Protocol and the Global Laboratory and
Analytical Use Exemption
II. Extension of the Global Laboratory and Analytical Use Exemption
III. Applicability of the Global Laboratory and Analytical Use
Exemption to Methyl Bromide
IV. Statutory and Executive Order Reviews
    A. Executive Order No. 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order No. 13132: Federalism
    F. Executive Order No. 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order No. 13045: Protection of Children From
Environmental Health & Safety Risks
    H. Executive Order No. 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer Advancement Act
    J. Congressional Review Act

I. Background on the Montreal Protocol and the Global Laboratory and
Analytical Use Exemption

    The Montreal Protocol on Substances that Deplete the Ozone Layer
(Protocol) is the international agreement to reduce and eventually
eliminate the production and consumption \1\ of all stratospheric
ozone-depleting substances (ODSs). The elimination of production and
consumption of ODSs is accomplished through adherence to phaseout
schedules for specific class I ODSs,\2\ including: chlorofluorocarbons
(CFCs), halons, carbon tetrachloride, and methyl chloroform. The Clean
Air Act, as amended in 1990 and 1998, requires EPA to promulgate
regulations implementing the Protocol's phaseout schedules in the
United States. Those regulations are codified at 40 CFR part 82. As of
January 1, 1996, production and import of most class I ODSs were phased
out in developed countries, including the United States.
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    \1\ ``Consumption'' is defined as the amount of a substance
produced in the United States, plus the amount imported into the
United States, minus the amount exported to Parties to the Montreal
Protocol (see Section 601(6) of the Clean Air Act). Stockpiles of
class I ODSs produced or imported prior to the 1996 phaseout may be
used for purposes not expressly banned at 40 CFR part 82.
    \2\ Class I ozone depleting substances are listed at 40 CFR part
82, subpart A, appendix A.
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    However, the Protocol provides exemptions that allow for the
continued import and/or production of ODSs for specific uses. Under the
Protocol, for

most class I ODSs, the Parties may collectively grant exemptions to the
ban on production and import of ODSs for uses that they determine to be
``essential.'' For example, with respect to CFCs, Article 2A(4)
provides that the phaseout will apply ``save to the extent that the
Parties decide to permit the level of production or consumption that is
necessary to satisfy uses agreed by them to be essential.'' Similar
language appears in the control provisions for halons (Art. 2B), carbon
tetrachloride (Art. 2D), methyl chloroform (Art. 2E),
hydrobromochlorofluorocarbons (Art. 2G), and bromochloromethane (Art.
2I). As defined by Decision IV/25 of the Parties, use of a controlled
substance is essential only if (1) it is necessary for the health,
safety or is critical for the functioning of society (encompassing
cultural and intellectual aspects), and (2) there are no available
technically and economically feasible alternatives or substitutes that
are acceptable from the standpoint of environment and health.
    Decision X/19 under the Protocol (taken in 1998) allowed a general
exemption for essential laboratory and analytical uses through December
31, 2005. EPA included this exemption in our regulations at 40 CFR part
82, subpart A. While the Clean Air Act does not specifically provide
for this exemption, EPA determined that an exemption for essential
laboratory and analytical uses was allowable under the Act as a de
minimis exemption. EPA addressed the de minimis exemption in the final
rule of March 13, 2001 (66 FR 14760-14770).
    Decision X/19 also asked the Protocol's Technology and Economic
Assessment Panel (TEAP), a group of technical experts from member
countries, to report annually on procedures that could be performed
without the use of controlled substances and stated that at future
meetings the Parties would decide whether such procedures should no
longer be eligible for exemptions. Based on the TEAP's recommendation,
the Parties to the Protocol decided in 1999 (Decision XI/15) that the
general exemption no longer applied to the following uses: Testing of
oil and grease, and total petroleum hydrocarbons in water; testing of
tar in road-paving materials; and forensic finger-printing. EPA
incorporated this exclusion at Appendix G to Subpart A of 40 CFR part
82 on February 11, 2002 (67 FR 6352).
    Subsequently, in its May 2003 progress report the TEAP noted, ``No
new non-ODS methods have been forthcoming which would enable the TEAP
to recommend the elimination of further uses of controlled substances
for analytical and laboratory uses'' (p. 106, see Air Docket OAR-2004-
0064). Based on this statement, and in consideration of the pending
cessation of the laboratory use exemption in 2005, the European
Community proposed an extension of the exemption that would allow
further time for development of non-ODS methods. At their fifteenth
Meeting in November 2003, the Parties adopted the proposal in Decision
XV/8, which extended the global exemption for laboratory and analytical
uses to December 31, 2007.
    EPA's regulations regarding this exemption at 40 CFR 82.8(b)
currently state, ``A global exemption for class I controlled substances
for essential laboratory and analytical uses shall be in effect through
December 31, 2005 subject to the restrictions in appendix G of this
subpart, and subject to the record-keeping and reporting requirements
at Sec.  82.13(u) though (x). There is no amount specified for this
exemption.'' Because certain laboratory procedures continue to require
the use of class I substances in the United States, and because non-ODS
replacements for the class I substances have not been identified for
all uses, EPA is revising 40 CFR 82.8(b) to reflect the extension of
the exemption to 2007 consistent with Decision XV/8. For a more
detailed discussion of the reasons for the exemption, refer to the
March 13, 2001, Federal Register notice.

II. Extension of the Global Laboratory and Analytical Use Exemption

    With today's action, EPA is extending the laboratory and analytical
use exemption from December 31, 2005, to December 31, 2007. This
exemption allows for production and import of certain ODSs to meet
laboratory and analytical needs.
    EPA received three sets of comments on the proposed rule (70 FR
25726), two of which did not support extending the exemption and one
late comment which did support extending the exemption. One commenter
indicated that as long as there is an exemption program, industry will
not have an incentive to seek alternatives. EPA believes that the time-
limited nature of the exemption program, first through 2005 and now
through 2007, does provide industry with an incentive to continue to
explore alternatives. The Agency notes that many of the exempted uses
are for niche applications or for experimental work of importance to
society. For example, some federal and state laws, including
regulations issued under the Clean Air Act and the Clean Water Act,
require testing of the water, soil, or air to measure compliance with
environmental standards. A pure sample of an ODS may be necessary to
properly calibrate the testing equipment and effectively monitor the
presence of chemicals of interest in the environment. A fuller
description of laboratory and analytical uses may be found in EPA's
2001 rulemaking on the topic (66 FR 14760) and in the comments in the
accompanying paper docket A-93-39.
    Furthermore, EPA notes that total consumption (defined as
production plus imports minus exports) for laboratory uses is small
relative to baseline and has declined over time. The amount of phased-
out class I substances being supplied to laboratories under this
exemption decreased each year since 1997 to reach the level of eight
metric tons in 2001 (approximately one-quarter the amount supplied in
1997), according to EPA's tracking system for ODSs.
    Another commenter expressed concern that the exemption would be
phased out ``eventually'' as described in the proposal and suggested
that the exemption should last only another two years. In today's
action, EPA is extending the laboratory and analytical use exemption by
two years recognizing, however, that after December 2007 there still
may be a need for this exemption. Should the Parties to the Montreal
Protocol take a decision to further extend the exemption beyond 2007,
EPA will seek comment on a new timeframe for the exemption.
    The commenter continues to express concern that the exemption
benefits companies at the expense of children and other members of the
public. As described above, this exemption services the research and
analytical community who are often engaged in work to protect the
public. The laboratory and analytical exemption was agreed to by the
Parties to the Montreal Protocol in Decisions X/19 and XV/8 as part of
the careful balancing intrinsic in any public policy discussion. As
discussed in the March 2001 notice, the controls in place for
laboratory and analytical uses provide adequate assurance that very
little, if any, environmental damage will result from the handling and
disposal of the small amounts of class I ODSs used in such
applications. Therefore, EPA does not anticipate significant
environmental impacts on the ozone layer as a result of today's action.

III. Applicability of the Global Laboratory and Analytical Use
Exemption to Methyl Bromide

    As of January 1, 2005, production and import of methyl bromide is
no longer allowed in the United States, except for limited exemptions
(40 CFR 82.4(d)). Methyl bromide is a class I controlled substance used
chiefly as a fumigant for soil treatment and pest control. In the
proposed rule, EPA sought comment on whether the global laboratory
exemption should include methyl bromide and also sought information on
laboratory and analytical processes that involve the use of small
quantities of methyl bromide. EPA only received one comment and it was
general in nature. The commenter indicated that she did not support any
exemptions for methyl bromide. Recognizing that further discussion of
whether the global laboratory exemption should include methyl bromide
may occur at a future meeting of the Parties to the Montreal Protocol,
EPA is deferring final action on this aspect of the proposed rule.

IV. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735 (October 4, 1993)), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to OMB review and the requirements of the
Executive Order. The Order defines ``significant regulatory action'' as
one that is likely to result in a rule that may: (1) Have an annual
effect on the economy of $100 million or more or adversely affect in a
material way the economy, a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local, or tribal governments or communities; (2) create a serious
inconsistency or otherwise interfere with an action taken or planned by
another agency; (3) materially alter the budgetary impact of
entitlements, grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raise novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order.
    It has been determined that this rule is not a ``significant
regulatory action'' under the terms of Executive Order 12866 and is
therefore not subject to OMB review.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden
because EPA is not creating new information or reporting requirements.
However, the Office of Management and Budget (OMB) has previously
approved the information collection requirements contained in the
existing regulations, as part of the final rule promulgated by the
Agency on May 10, 1995, under the provisions of the Paperwork Reduction
Act, 44 U.S.C. 3501 et seq. and has assigned OMB control number 2060-
0170 (EPA ICR number 1432). A copy of the OMB approved Information
Collection Request (ICR) may be obtained from Susan Auby, Collection
Strategies Division; U.S. Environmental Protection Agency (2822T); 1200
Pennsylvania Ave., NW., Washington, DC 20460 or by calling (202) 566-
1672.
    Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    EPA has determined that it is not necessary to prepare a regulatory
flexibility analysis in connection with this final rule.
    For purposes of assessing the impact of today's rule on small
entities, the term small entities is defined as: (1) A Pharmaceutical
preparations manufacturing business (NAICS code 325412); (2) a small
governmental jurisdiction that is a government of a city, county, town,
school district or special district with a population of less than
50,000; and (3) a small organization that is any not-for-profit
enterprise which is independently owned and operated and is not
dominant in its field.
    After considering the economic impacts of today's final rule on
small entities, EPA has concluded that this action will not have a
significant economic impact on a substantial number of small entities.
In determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the proposed rule on small entities.'' 5 U.S.C. 603
and 604. Thus, an agency may conclude that a rule will not have a
significant economic impact on a substantial number of small entities
if the rule relieves regulatory burden, or otherwise has a positive
economic effect on all of the small entities subject to the rule.''
    This rule provides an otherwise unavailable benefit to those
companies that obtain ozone depleting substances under the essential
laboratory and analytical use exemption. Today's action will extend the
Global Laboratory and Analytical Use Exemption (The Lab Exemption) from
its current expiration date of December 31, 2005 to December 31, 2007.
The Lab Exemption allows companies to produce CFCs and other Class I
ozone depleting substances (ODS), that are otherwise phased out, for
use of very small quantities of ODS in laboratory settings. We have
therefore concluded that today's final rule will relieve regulatory
burden for all small entities.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and adopt
the least costly, most cost-effective or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other

than the least costly, most cost-effective or least burdensome
alternative if the Administrator publishes with the final rule an
explanation why that alternative was not adopted. Before EPA
establishes any regulatory requirements that may significantly or
uniquely affect small governments, including tribal governments, it
must have developed under section 203 of the UMRA a small government
agency plan. The plan must provide for notifying potentially affected
small governments, enabling officials of affected small governments to
have meaningful and timely input in the development of EPA regulatory
proposals with significant Federal intergovernmental mandates, and
informing, educating, and advising small governments on compliance with
the regulatory requirements.
    Today's rule contains no Federal mandates (under the regulatory
provisions of Title II of the UMRA) for State, local, or tribal
governments or the private sector, since it merely extends the
availability of an already available exemption to the ban on production
and import of class I ODSs. For the same reason, EPA has determined
that this rule contains no regulatory requirements that might
significantly or uniquely affect small governments.

E. Executive Order No. 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), 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 does not have federalism implications. It will not
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,
as specified in Executive Order 13132. Today's rule affects only the
companies that produce or import class I ozone-depleting substances for
laboratory or analytical uses. Thus, Executive Order 13132 does not
apply to this rule.

F. Executive Order No. 13175: Consultation and Coordination With Indian
Tribal Governments

    Executive Order No. 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
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.'' This final rule does not have
tribal implications, as specified in Executive Order No. 13175. Today's
final rule does not significantly or uniquely affect the communities of
Indian tribal governments. The final rule does not impose any
enforceable duties on communities of Indian tribal governments. Thus,
Executive Order No. 13175 does not apply to this final rule.

G. Executive Order No. 13045: Protection of Children From Environmental
Health & Safety Risks

    Executive Order No. 13045: ``Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997) applies to any rule that: (1) Is determined to be ``economically
significant'' as defined under Executive Order 12866, and (2) concerns
an environmental health or safety risk that EPA has reason to believe
may have a disproportionate effect on children. If the regulatory
action meets both criteria, the Agency must evaluate the environmental
health or safety effects of the planned rule on children, and explain
why the planned regulation is preferable to other potentially effective
and reasonably feasible alternatives considered by the Agency.
    While this proposed rule is not subject to the Executive Order
because it is not economically significant as defined in Executive
Order 12866, we nonetheless have reason to believe that the
environmental health or safety risk addressed by this action may have a
disproportionate effect on children. Depletion of stratospheric ozone
results in greater transmission of the sun's ultraviolet (UV) radiation
to the earth's surface. The following studies describe the effects on
children of excessive exposure to UV radiation: (1) Westerdahl J,
Olsson H, Ingvar C. ``At what age do sunburn episodes play a crucial
role for the development of malignant melanoma,'' Eur J Cancer 1994;
30A: 1647-54; (2) Elwood JM, Jopson J. ``Melanoma and sun exposure: an
overview of published studies,'' Int J Cancer 1997; 73:198-203; (3)
Armstrong BK. ``Melanoma: childhood or lifelong sun exposure'' In:
Grobb JJ, Stern RS, Mackie RM, Weinstock WA, eds. ``Epidemiology,
causes and prevention of skin diseases,'' 1st ed. London, England:
Blackwell Science, 1997: 63-6; (4) Whiteman D., Green A. ``Melanoma and
Sunburn,'' Cancer Causes Control, 1994: 5:564-72; (5) Kricker A,
Armstrong, BK, English, DR, Heenan, PJ. ``Does intermittent sun
exposure cause basal cell carcinoma? A case control study in Western
Australia,'' Int J Cancer 1995; 60: 489-94; (6) Gallagher, RP, Hill,
GB, Bajdik, CD, et. al. ``Sunlight exposure, pigmentary factors, and
risk of nonmelanocytic skin cancer I, Basal cell carcinoma,'' Arch
Dermatol 1995; 131: 157-63; (7) Armstrong, BK. ``How sun exposure
causes skin cancer: an epidemiological perspective,'' Prevention of
Skin Cancer. 2004. 89-116. The public is invited to submit or identify
peer-reviewed studies and data, of which EPA may not be aware, that
assessed results of early life sun exposure.
    However, as discussed in the March 13, 2001, Federal Register
notice, the laboratory and analytical applications addressed in today's
proposed rule involve extremely controlled use and disposal of all
chemicals, including any ODS. As a result, emissions of ODS into the
atmosphere are negligible. In light of the conditions already applied
to the global exemption by appendix G to subpart A of 40 CFR part 82,
EPA believes that any additional controls on laboratory uses would
provide little, if any, benefit.

H. Executive Order No. 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This rule is not a ``significant energy action'' as defined in
Executive Order No. 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355
(May 22, 2001)) because it is not a significant regulatory action under
Executive Order 12866.

I. National Technology Transfer Advancement Act

    As noted in the proposed rule, section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (``NTTAA''), Public
Law. No. 104-113, section 12(d) (15 U.S.C. 272 note) directs EPA to use
voluntary consensus standards in its regulatory activities unless to do
so would be inconsistent with applicable law or otherwise impractical.
Voluntary consensus standards are technical standards (e.g., materials
specifications, test methods, sampling procedures, and business
practices) that are developed or adopted

by voluntary consensus standards bodies. The NTTAA directs EPA to
provide Congress, through OMB, explanations when the Agency decides not
to use available and applicable voluntary consensus standards. This
action does not involve technical standards. Therefore, EPA did not
consider the use of any voluntary consensus standards.

J. 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 the rule in the Federal Register. A Major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective on January 1, 2006.

List of Subjects in 40 CFR Part 82

    Environmental protection, Administrative practice and procedures,
Air pollution control, Chemicals, Exports, Imports, Ozone, Production,
Reporting and recordkeeping requirements, Treaties.

    Dated: December 22, 2005.
Stephen L. Johnson,
Administrator.

0
40 CFR Part 82 is amended as follows:

PART 82--PROTECTION OF STRATOSPHERIC OZONE

0
1. The authority citation for part 82 continues to read as follows:

    Authority: 42 U.S.C. 7414, 7601, 7671-7671q.

Subpart A--Production and Consumption Controls

0
2. Section 82.8 is amended by revising paragraph (b) to read as
follows:

Sec.  82.8  Grant of essential use allowances and critical use
allowances.

* * * * *
    (b) A global exemption for class I controlled substances for
essential laboratory and analytical uses shall be in effect through
December 31, 2007, subject to the restrictions in appendix G of this
subpart, and subject to the record keeping and reporting requirements
at Sec.  82.13(u) through (x). There is no amount specified for this
exemption.
* * * * *

[FR Doc. 05-24612 Filed 12-28-05; 8:45 am]

BILLING CODE 6560-50-P


1 NRDC comments for the HSRB meeting April 4 6, 2006 Jennifer Sass, Ph. D.

Public health program Washington, DC Tel: 202 289 6868; www. nrdc. org 2 ALDICARB ( N methyl carbamate)

° Banned: Libya, Tanzania, Indonesia, Finland, Sweden,

St. Lucia, Kuwait ° Restricted: Morocco, Sudan, Togo, Germany,

Argentina, Belize,

° Registrant: Aventis, Union Carbide ° Listed by WHO as 1a, extremely hazardous 3 Aldicarb effects on humans 0.075 0.025 0.0023 0.05 0.01 0 0.01 0.02 0.03 0.04 0.05 0.06 0.07 0.08 Rhone Poulenc Union Carbide Goldman et al.

mg/

kg LOEL NOEL EPA using R P study with LOAEL ( 0.05); EPA considered U C study ethically flawed; EPA did not consider Goldman incident data 4 Incident data ( Goldman et al, 1990)

Estimated dosages ranged between 0.0023

0.06 mg/ kg; most were well below the 0.025 mg/ kg ( LOEL) for sub clinical blood cholinesterase depression previously reported for humans. These findings are consistent with aldicarb sulfoxide ( ASO) illnesses that have occurred in other states.

Goldman LR, Beller M, Jackson RJ. 1990. Aldicarb food poisonings in California, 1985 1988: toxicity estimates for humans. Arch Environ Health, May June, 45( 3): 141 147. Erratum in: Arch Environ Health 1990 Nov Dec; 45( 6): following 380 5 ( Goldman et al, 1990)

A total of 28 cases, defined as nausea, vomiting,

diarrhea within 2 h of produce consumption.

The lowest dosage associated with illness ( 0.0023 mg/ kg) was a 66 yr old woman, who ate a contaminated cucumber. " Within 45 minutes she experienced nausea, vomiting, sweating, dizziness,

loss of balance, disorientation, and fatigue."

more severe illnesses requiring hospital treatment occurred only in cases with estimated dosages greater than 0.01 mg/ kg body weight.

One person required atropine treatment following an estimated dose of 0.054 mg/ kg 6 Rhone Poulenc, 1992 single oral dose double blind, placebo controlled study of aldicarb given to healthy male and female subjects.

Doses: placebo ( 16 males and 6 females), 0.01 mg/ kg ( 8 males), 0.025 mg/ kg ( 8 males and 4 females), 0.05 mg/ kg ( 8 males and 4 females), and 0.075 mg/ kg ( 4 males).

The study reports that RBC ChEi was maximal at 1 4 hours after dosing, and was statistically significantly depressed compared with the placebo group, at all doses.

° the subjects who received 0.01 mg/ kg, the study reports a marginal reduction in cholinesterase activity of 3% at 1 hr post dose;

° the 0.025 mg/ kg group shown a mean reduction of 10%;

° the 0.05 mg/ kg group showed a mean reduction of 30%;

° the 0.075 mg/ kg group showed a mean reduction of 45%. 7 R P conclude that the clinical no effect level, based on symptoms of sweating in the high dose subject, is considered to be 0.05 mg/ kg.

The authors defined a treatment related effect has having both a pharmacological and a time relationship to treatment.

A total of 24 adverse events were reported by the subjects:

° 11 in the placebo group ( in 6 of 22 subjects),

° 5 in the 0.01 mg/ kg dose group ( in 3 of 8 subjects),

° 3 in the 0.025mg/ kg dose group ( in 2 of 12 subjects),

° 1 in the 0.05 mg/ kg dose group ( in 1 of 12 subjects), and ° 4 in the 0.075 mg/ kg dose group ( in 3 of 4 subjects). 8 General statistical considerations

One of the critical issues in evaluating the scientific validity of a study design is statistical power. A study with inadequate power to find an effect is by definition unethical.

There are roughly 19 million children in the United States   5 years of age. If a toxicant harmed 1 child in 1,000, that would place 19,000 children at risk nationwide. A study with adequate power to detect an increase in deficit from 1% to 2% would require 3,017 subjects in each group to yield a power of 0.8, at p=

0.05.

Studies with sample sizes < 50 had about a 3% chance of finding an effect if it were present. 9 NRDC POSITION ° Studies should only be considered where they will a priori have demonstrated validity of study design,

statistical power, and sample size ° Industry sponsorship may bias study design, data analysis, or interpretation. This also applies to in house IRB.

° Study subjects are usually limited to healthy adults, often males, and are not representative of the general population ° Risks accrue to subjects, while argued benefits accrue to society ( pesticide residue in food has no known health benefits) 10 DICHLORVOS ( DDVP) ( Organophosphate)

Carcinogenic in rats and mice at multiple sites ( Chan et al, 1991)

Induces gene mutations and chromosomal damage in mammalian cells

Cancer effects are not revealed by measurement of ChE

WHO listed as 1b, highly hazardous

IARC listed as 2B, possible human carcinogen

California prop65 known human carcinogen

U. S. EPA group C, possible human carcinogen

Banned in Angola, Fiji, Denmark, United Kingdom,

Cancelled in Sweden

Restricted in Kuwai 11 Dichlorvos MRID442488 01 7 mg oral dose daily from days 1 18, all male 3 control ( solid lines), 6 treated ( broken lines)

70 75 80 85 90 95 100 105 110 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 day of blood draw %

mean baseline ChE Amvac called this a NOAEL; EPA called it a LOAEL 12 EPA determined:

Human repeated dose study is well supported by several animal studies and should serve as the basis for short and intermediate term risks

21 day human study RBC ChEi LOAEL= 0.1 mg/ kg/ day ( this is the only dose tested, and is an approximate,

since each subject was given 7 mg, and mg/ kg was an average of the subjects)

MOE= 100 ( intra 10X, lack of NOAEL 3x, FQPA 3x) 13 NRDC position

There is no value added from the human subjects test that is not already available from well conducted animal studies, epidemiology, incident data, and biomonitoring data

The human subjects data are often limited to healthy adults, and do not capture differences across the population, chronic effects, effects from early life stage exposures

Providing EPA with an expert review of an EPA expert review is uncomfortably tautological, and does not constitute appropriate independent peer review 14 AZINPHOS METHYL ( AZM)

act on the human system to inhibit acetylcholinesterase;

readily absorbed through the skin;

induce systemic effects which include headache,

dizziness, weakness, shaking, nausea, stomach cramps, diarrhea, sweating;

may induce skin rashes and irritation; and

may induce delayed/ allergic effects including loss of appetite, weakness, weight loss, and general malaise. 15 AZM ethical determinations:

test was done on eight " volunteers" who were hospitalized for a month, were dosed with a known poison, took repeated blood and urine tests, and gave up many freedoms, all for just £ 1500, suggesting participants were economically distressed.

The consent form mentions no specific adverse effects that are possible. None of the long term chronic effects associated with OPs are mentioned in any form given to subjects.

The " volunteer information" ( VI) form says that previous studies show AZM has " no side effects other than the intended effect," of cholinesterase inhibition ( it is unclear whether subjects were fully briefed on the VI form).

Although the VI form mentions short term acute effects that could occur, it says they are " not anticipated" in the study. 16 AZM ethical considerations

The actual consent form signed by subjects misleadingly states that the study may be disclosed " for medicines in the UK and elsewhere," when there was no intention to use the study for medicines.

subjects apparently were not informed that researchers were Bayer contractors

consent form required subjects to agree that if injured,

rather than suing, they would submit any dispute to an arbitrator ( who had to be agreed to by the company)

The IRB chair has the same last name as a lead investigator on the study. 17 Scientific considerations of the AZM study:

It tests just 8 adult males, with one dose ( 0.25 mg/ kg)

for 28 days

Designed as a " no effect" ( NOAEL) study

EPA and study authors determined that the one dose administered was a " no effect" level 18 Adverse events reported in the AZM study:

Adverse effects:

Total post dose adverse effects = 67

17 in placebo group ( 25%); average of 4.24 different adverse effects per person

50 in treatment group ( 75%): average of 6.25 different adverse effects per person

NOTE: multiple complaints were never recorded.

while only one placebo subject reported experiencing one single GI system disorder ( nausea), the treatment group subjects ( 4 reporting/ 8 total subjects) reported an array of GI disorders ( nausea, flatulence, dyspepsia). ( Table P1.2; p. P4) ALL THESE ARE KNOWN RESULTS OF OP poisoning.

75% of treated subjects ( N= 6) report adverse effects ( coughing,

epistaxis, rhinitis) versus 25% of placebo subjects ( N= 1) ( Table P1.2; p. 5) 19 AZM study adverse effects:

although the study reports that none of the 67 post dose adverse events were considered to be related to the test compound ( p. 48, Section 8.4.3), all adverse events " resolved themselves" by the post study follow up ( Table P2.2, p. P34). That is, the treatment group who had reported adverse effects during the treatment period seem to have been cured when no longer receiving treatment. 20 AZM adverse effects

The report makes the claim that the adverse effects were not related to treatment because they were not correlated with " clinically relevant depression from mean baseline value of RBC or plasma cholinesterase,

relating to the time of onset of adverse event in any subject." ( p. 52, section 8.4.3).

However, by their own " retrospective power calculation"

they had no statistical power to detect fluctuations in the ranges reported in the study ( i. e. within 15% of baseline). 21

a retrospective power calculation ( p. 31 32) states that the study has an 85% power to detect a 15% difference in cholinesterase levels.

Very few of these % differences are beyond 15%. ( Fig.

M1.1.1 ( p. M6), Table M2.1 ( p. M45 50).

MANY ADVERSE EFFECTS ARE SEEN IN THE TREATMENT SUBJECTS; the placebo group ( N= 4) had 2 subjects reported to have adverse effects, while the treatment group ( N= 8) had every single person report adverse effects ( Table P1.1, page P3). Although nothing in this entire report has any statistical significance, this may be of considerable scientific interest 22 NRDC POSITION:

Studies should only be considered where they will a priori have demonstrated validity of study design,

statistical power, and sample size

Study subjects are usually limited to healthy adults,

often males, and are not representative of the general population

There is no value added from the human subjects test that is not already determined from well conducted animal studies, epidemiology studies, incident data, and biomonitoring data.

A scientific and ethical review of these data cannot be done with confidence if the HSRB is not provide the original study report, original informed consent forms,

and IRB approval documentation.


[Federal Register Volume 88, Number 223 (Tuesday, November 21, 2023)]
[Notices]
[Pages 81166-81171]
[FR Doc No: 2023-25656]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98934; File No. SR-NASDAQ-2023-044]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend The Nasdaq Options Market LLC Pricing Schedule at Options 7,
Section 2

November 15, 2023.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 1, 2023, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III, below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend The Nasdaq Options Market LLC
(``NOM'') Pricing Schedule at Options 7, Section 2.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/nasdaq/rules, at
the principal office of the Exchange, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to amend NOM's Pricing
Schedule at Options 7, Section 2(1) (setting forth fees and rebates for
execution of contract on NOM) and Section 2(3) (setting forth fees for
routing contracts to markets other than NOM). Each change will be
described below.
Options 7, Section 2(1)
Fees To Remove Liquidity in Non-Penny Symbols
    As set forth in Options 7, Section 2(1), the Exchange currently
charges NOM Market Makers,\3\ Non-NOM Market Makers,\4\ Firms,\5\ and
Broker-Dealers \6\ a $1.10 per contract fee for removing liquidity in
Non-Penny Symbols. The Exchange now proposes to increase this fee to
$1.25 per contract.
---------------------------------------------------------------------------

    \3\ The term ``NOM Market Maker'' or (``M'') is a Participant
that has registered as a Market Maker on NOM pursuant to Options 2,
Section 1, and must also remain in good standing pursuant to Options
2, Section 9. In order to receive NOM Market Maker pricing in all
securities, the Participant must be registered as a NOM Market Maker
in at least one security.
    \4\ The term ``Non-NOM Market Maker'' or (``O'') is a registered
market maker on another options exchange that is not a NOM Market
Maker. A Non-NOM Market Maker must append the proper Non-NOM Market
Maker designation to orders routed to NOM.
    \5\ The term ``Firm'' or (``F'') applies to any transaction that
is identified by a Participant for clearing in the Firm range at
OCC.
    \6\ The term ``Broker-Dealer'' or (``B'') applies to any
transaction which is not subject to any of the other transaction
fees applicable within a particular category.
---------------------------------------------------------------------------

Note 8 Incentive
    Today, the Exchange provides Customers \7\ with tiered rebates for
adding liquidity in Penny Symbols that are $0.20 (Tier 1), $0.25 (Tier
2), $0.43 (Tier 3), $0.44 (Tier 4), $0.45 (Tier 5), and $0.48 (Tier 6).
These rebates are paid based on the highest volume tier that the
Customer achieves in a given month.\8\
---------------------------------------------------------------------------

    \7\ The term ``Customer'' or (``C'') applies to any transaction
that is identified by a Participant for clearing in the Customer
range at The Options Clearing Corporation (``OCC'') which is not for
the account of broker or dealer or for the account of a
``Professional'' (as that term is defined in Options 1, Section
1(a)(47)).
    \8\ See Options 7, Section 2(1), note 1.
---------------------------------------------------------------------------

    Today, the Exchange also links the tiered Penny Symbol Customer add
liquidity rebate program described above to its Market Access and
Routing Subsidy (``MARS'') program in Section 2(4) as a means to
attract additional liquidity to the Exchange from market participants.
Under MARS, the Exchange pays qualifying NOM Participants to subsidize
their costs of providing routing services to route orders to NOM. To
qualify for MARS, NOM Participants must have System Eligibility.\9\ In
addition, NOM Participants that have System Eligibility, and have
routed and executed the requisite number of Eligible Contracts \10\
daily in a month (``Average Daily Volume'' or ``ADV'') that add
liquidity on NOM are entitled to the tiered MARS Payments set forth in
Section 2(4), depending on the highest ADV tier achieved.\11\
---------------------------------------------------------------------------

    \9\ To qualify for MARS, the Participant's routing system
(``System'') would be required to: (1) enable the electronic routing
of orders to all of the U.S. options exchanges, including NOM; (2)
provide current consolidated market data from the U.S. options
exchanges; and (3) be capable of interfacing with NOM's API to
access current NOM match engine functionality. Further, the
Participant's System would also need to cause NOM to be the one of
the top three default destination exchanges for (a) individually
executed marketable orders if NOM is at the national best bid or
offer (``NBBO''), regardless of size or time or (b) orders that
establish a new NBBO on NOM's Order Book, but allow any user to
manually override NOM as a default destination on an order-by-order
basis. Any NOM Participant would be permitted to avail itself of
this arrangement, provided that its order routing functionality
incorporates the features described above and satisfies NOM that it
appears to be robust and reliable. The Participant remains solely
responsible for implementing and operating its System.
    \10\ For the purpose of qualifying for the MARS Payment,
Eligible Contracts may include Firm, Non-NOM Market Maker, Broker-
Dealer, or Joint Back Office or ``JBO'' equity option orders that
add liquidity and are electronically delivered and executed.
Eligible Contracts do not include Mini Option orders.
    \11\ The specified MARS Payment will be paid on all executed
Eligible Contracts that add liquidity, which are routed to NOM
through a participating NOM Participant's System and meet the
requisite Eligible Contracts ADV. No payment will be made with
respect to orders that are routed to NOM, but not executed.
---------------------------------------------------------------------------

    In particular, the Exchange currently links the tiered Penny Symbol
Customer rebate to add liquidity program in Penny Symbols and MARS,
each as described above, through note 8 of Options 7, Section 2(1)
where NOM Participants that qualify for any MARS Payment Tier in
Section 2(4) receive: (1) an additional $0.05 per contract Penny Symbol
Customer Rebate to Add Liquidity for each transaction which adds
liquidity in Penny Symbols in that month, in addition to qualifying
Customer Rebate to Add Liquidity Tiers 1-5, or (2) an additional $0.04
per contract Penny Symbol Customer Rebate to Add Liquidity for each
transaction which adds liquidity in Penny Symbols in that month, in
addition to qualifying Penny Symbol Customer Rebate to Add Liquidity
Tier 6 (``Note 8 Incentive''). As such, NOM Participants may earn
Customer Rebates to Add Liquidity in Penny Symbols up to $0.25 in Tier
1, $0.30 in Tier 2, $0.48 in Tier 3, $0.49 in Tier 4, $0.50 in Tier 5,
and $0.52 in Tier 6, provided they meet the qualifications in note 8.
    The Note 8 Incentive was intended to attract additional order flow
to NOM by way of encouraging participation in both the tiered Customer
add liquidity rebate program and in MARS. The Exchange, however, has
observed that this rebate program has not accomplished its objective
and therefore proposes to eliminate this program in note 8 of Options
7, Section 2(1).
Note 9 Incentive
    Today, pursuant to note 9 of Options 7, Section 2(1), NOM
Participants that transact in all securities through one or more of its
Nasdaq Market Center MPIDs that represent 3.00% or more of Consolidated
Volume in the same month on The Nasdaq Stock Market receive a $0.50 per
contract Rebate to Add Liquidity in Penny Symbols as Customer, a $0.48
per contract rebate as Professional,\12\ a $1.00 per contract Rebate to
Add Liquidity in Non-Penny Symbols as Customer, and a $0.90 per
contract Rebate to Add liquidity in Non-Penny Symbols as Professional
(``Note 9 Incentive''). Participants that qualify for the Note 9
Incentive are not be eligible for any other rebates in Tiers 1-6 or
other rebate incentives on NOM for Customer and Professional order flow
in Options 7, Section 2(1).
---------------------------------------------------------------------------

    \12\ The term ``Professional'' or (``P'') means any person or
entity that (i) is not a broker or dealer in securities, and (ii)
places more than 390 orders in listed options per day on average
during a calendar month for its own beneficial account(s) pursuant
to Options 1, Section 1(a)(47). All Professional orders shall be
appropriately marked by Participants.
---------------------------------------------------------------------------

    The Exchange now proposes to increase $1.00 Customer Rebate to Add
Liquidity in Non-Penny Symbols to $1.10. The Exchange is increasing the
rebate amount without changing the

qualifications in the Note 9 Incentive so that NOM Participants can
bring the same amount of volume as they do today on The Nasdaq Stock
Market to receive larger rebate in Customer Add Liquidity volume in
Non-Penny Symbols.\13\ Overall, the Exchange believes that the
increased rebate will bring greater volume to both The Nasdaq Stock
Market and NOM, to the benefit of all market participants.
---------------------------------------------------------------------------

    \13\ Any NOM Participant may trade equities on The Nasdaq Stock
Market because they are already approved members. Although a NOM
Participant may potentially incur additional labor and/or costs to
establish connectivity to The Nasdaq Stock Market, there are no
additional membership fees for NOM Participants that want to
transact on The Nasdaq Stock Market.
---------------------------------------------------------------------------

Note 10 Incentive
    Today, pursuant to note 10 of Options 7, Section 2(1), NOM
Participants that (a) add Customer, Professional, Firm, Non-NOM Market
Maker and/or Broker-Dealer liquidity in Penny Symbols and/or Non-Penny
Symbols above 1.20% of total industry customer equity and ETF option
ADV contracts per day in a month, (b) execute greater than 0.04% of
Consolidated Volume (``CV'') via Market-on-Close/Limit-on-Close (``MOC/
LOC'') volume within The Nasdaq Stock Market Closing Cross within a
month, and (c) add greater than 1.5 million shares per day of non-
displayed volume within The Nasdaq Stock Market within a month receive
a $0.55 per contract Rebate to Add Liquidity in Penny Symbols as
Customer, a $0.48 per contract Rebate to Add Liquidity in Penny Symbols
as Professional, and a $1.05 per contract Rebate to Add Liquidity in
Non-Penny Symbols as Customer, and a $0.90 per contract Rebate to Add
Liquidity in Non-Penny Symbols as Professional (``Note 10 Incentive'').
Participants that qualify for the Note 10 Incentive are not be eligible
for any other rebates in Tiers 1-6 or other rebate incentives on NOM
for Customer and Professional order flow in Options 7, Section 2(1).
    The Exchange now proposes to amend the NOM volume threshold in part
(a) of the Note 10 Incentive by increasing 1.20% to 1.50% of total
industry customer equity and ETF option ADV contracts per day in a
month. The Exchange also proposes to increase the $1.05 Customer Rebate
to Add Liquidity in Non-Penny Symbols to $1.15. No other changes are
being proposed to the rebates and qualifications in the Note 10
Incentive. As amended, the Note 10 Incentive will provide: ``NOM
Participants that (a) add Customer, Professional, Firm, Non-NOM Market
Maker and/or Broker-Dealer liquidity in Penny Symbols and/or Non-Penny
Symbols above 1.50% of total industry customer equity and ETF option
ADV contracts per day in a month, (b) execute greater than 0.04% of
Consolidated Volume (``CV'') via Market-on-Close/Limit-on-Close (``MOC/
LOC'') volume within The Nasdaq Stock Market Closing Cross within a
month, and (c) add greater than 1.5 million shares per day of non-
displayed volume within The Nasdaq Stock Market within a month will
receive a $0.55 per contract Rebate to Add Liquidity in Penny Symbols
as Customer, a $0.48 per contract Rebate to Add Liquidity in Penny
Symbols as Professional, and a $1.15 per contract Rebate to Add
Liquidity in Non-Penny Symbols as Customer, and a $0.90 per contract
Rebate to Add Liquidity in Non-Penny Symbols as Professional.
Participants that qualify for this rebate would not be eligible for any
other rebates in Tiers 1-6 or other rebate incentives on NOM for
Customer and Professional order flow in Options 7, Section 2(1).''
Options 7, Section 2(3)
    As set forth in Options 7, Section 2(3), the Exchange currently
assesses a Non-Customer routing fee of $0.99 per contract to any
options exchange. The Exchange also assesses a Customer routing fee of
$0.23 per contract, in addition to the actual transaction fee assessed
by the away market, for routing contracts to any options exchange other
than the Exchange's affiliates, Nasdaq BX, Inc. (``BX'') and Nasdaq
Phlx LLC (``Phlx''). If the away market (other than BX and Phlx) pays a
rebate, this Customer routing fee is $0.13 per contract instead. When
routing to BX and Phlx, the Exchange currently assesses a Customer
routing fee of $0.13 per contract in addition to the actual transaction
fee assessed.
    At this time, the Exchange proposes to assess a Non-Customer an
increased routing fee to route to any options exchange of $1.20 per
contract. The Exchange also proposes to assess a Customer a routing fee
of $0.23 per contract, in addition to the actual transaction fee
assessed by the away market, for routing contracts to any options
exchange. With this change, the Exchange would no longer assess the
lower routing of $0.13 per contract, in addition to the actual
transaction fee assessed, when routing to BX and Phlx. The Exchange
would continue to assess a $0.13 per contract routing fee if the away
market pays a rebate, including BX and Phlx. The purpose of the
proposed routing fees is to recoup costs incurred by the Exchange when
routing orders to other options exchanges on behalf of NOM
Participants. In determining its proposed routing fees, the Exchange
took into account transaction fees assessed by other options exchanges,
the Exchange's projected clearing costs, and the projected
administrative, regulatory, and technical costs associated with routing
orders to other options exchanges. The Exchange will continue to use
its affiliated broker-dealer, Nasdaq Execution Services, to route
orders to other options exchanges. Routing services offered by the
Exchange are completely optional and market participants can readily
select between various providers of routing services, including other
exchanges and broker-dealers. Also, the Exchange notes that NOM
Participants may elect to mark their orders as ``Do-Not-Route'' to
avoid any routing fees.\14\ The Exchange believes that the proposed
routing fees would enable the Exchange to recover the costs it incurs
to route orders to away markets after taking into account the other
costs associated with routing orders to other options exchanges. Also,
the Exchange's proposal would uniformly assess the same Customer
routing fees, regardless of the away venue, of $0.23 per contract, in
addition to the actual transaction fee assessed, or $0.13 per contract
of the away market pays a rebate.
---------------------------------------------------------------------------

    \14\ See Options 3, Section 7(c).
---------------------------------------------------------------------------

Technical Amendment
    The Exchange proposes a technical amendment in note 11 of Options
7, Section 2(1). Note 11 currently provides that NOM Participants that
qualify for the Tier 5 NOM Market Maker Rebate to Add Liquidity in
Penny Symbols and add NOM Market Maker liquidity in Penny Symbols and/
or Non-Penny Symbols of above 0.50% of total industry customer equity
and ETF option ADV contracts per day in a month, will receive a $0.46
contract rebate to add liquidity in Penny Symbols as Market Maker in
lieu of the Tier 5 rebate (``Note 11 Incentive''). The Tier 5 NOM
Market Maker Rebate to Add Liquidity in Penny Symbol currently has two
alternative routes in ``a'' and ``b'' to qualify for the Tier 5 rebate,
but when the Exchange adopted the Note 11 Incentive, the intent was to
provide the Note 11 Incentive for NOM participants that qualified
pursuant to route ``b'' in Tier 5.\15\ The Exchange subsequently
adopted an alternative

route ``a'' to qualify for the Tier 5 NOM Market Maker Rebate to Add
Liquidity in Penny Symbols, but did not update the Note 11 Incentive to
specify which route applied.\16\ The Exchange therefore proposes to
clarify that the Note 11 Incentive is available for NOM Participants
that qualify for the Tier 5(b) NOM Market Maker Rebate to Add Liquidity
in Penny Symbols. The proposed change will align the rule text with the
original intent of the incentive.
---------------------------------------------------------------------------

    \15\ See Securities Exchange Act Release No. 87276 (October 10,
2019), 84 FR 55644 (October 17, 2019) (SR-NASDAQ-2019-084). At the
time of adopting the Note 11 Incentive, only route ``b'' was
available to qualify for Tier 5.
    \16\ See Securities Exchange Act Release No. 98721 (October 11,
2023), 88 FR 71616 (October 17, 2023) (SR-NASDAQ-2023-040).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\17\ in general, and furthers the objectives of
Sections 6(b)(4) and 6(b)(5) of the Act,\18\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among members and issuers and other persons using any
facility, and is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78f(b).
    \18\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange's proposed changes to its Pricing Schedule are
reasonable in several respects. As a threshold matter, the Exchange is
subject to significant competitive forces in the market for options
securities transaction services that constrain its pricing
determinations in that market. The fact that this market is competitive
has long been recognized by the courts. In NetCoalition v. Securities
and Exchange Commission, the D.C. Circuit stated as follows: ``[n]o one
disputes that competition for order flow is `fierce.' . . . As the SEC
explained, `[i]n the U.S. national market system, buyers and sellers of
securities, and the broker-dealers that act as their order-routing
agents, have a wide range of choices of where to route orders for
execution'; [and] `no exchange can afford to take its market share
percentages for granted' because `no exchange possesses a monopoly,
regulatory or otherwise, in the execution of order flow from broker
dealers'. . . .'' \19\
---------------------------------------------------------------------------

    \19\ NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. Cir. 2010)
(quoting Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSEArca-2006-
21)).
---------------------------------------------------------------------------

    The Commission and the courts have repeatedly expressed their
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. In Regulation
NMS, while adopting a series of steps to improve the current market
model, the Commission highlighted the importance of market forces in
determining prices and SRO revenues and, also, recognized that current
regulation of the market system ``has been remarkably successful in
promoting market competition in its broader forms that are most
important to investors and listed companies.'' \20\
---------------------------------------------------------------------------

    \20\ Securities Exchange Act Release No. 51808 (June 9, 2005),
70 FR 37496, 37499 (June 29, 2005) (``Regulation NMS Adopting
Release'').
---------------------------------------------------------------------------

    Numerous indicia demonstrate the competitive nature of this market.
For example, clear substitutes to the Exchange exist in the market for
options security transaction services. The Exchange is only one of
seventeen options venues to which market participants may direct their
order flow. Within this environment, market participants can freely and
often do shift their order flow among the Exchange and competing venues
in response to changes in their respective pricing schedules. As such,
the proposal represents a reasonable attempt by the Exchange to
increase its liquidity and market share relative to its competitors.
Options 7, Section 2(1)
    The Exchange believes that the proposed changes to the fees and
rebates in Options 7, Section 2(1) are reasonable in several ways. The
Exchange believes that it is reasonable to increase the Fees to Remove
Liquidity in Non-Penny Symbols for NOM Market Makers, Non-NOM Market
Makers, Firms, and Broker-Dealers from $1.10 to $1.25 because the
proposed Non-Penny Symbol fee increases will be balanced by the Non-
Penny Symbol rebate increases for Customers, which are intended to
improve overall market quality on the Exchange by incentivizing market
participants to bring additional order flow and, in turn, provide more
trading opportunities to the benefit of all market participants. As
discussed above, the Exchange is proposing to increase the Non-Penny
Symbol Customer Rebate to Add Liquidity in the Note 9 Incentive from
$1.00 to $1.10 per contract without amending the current volume
qualifications in note 9 so that NOM Participants can bring the same
amount of volume as they do today on The Nasdaq Stock Market to receive
larger rebate in Customer Add Liquidity volume in Non-Penny
Symbols.\21\ The Exchange believes that the increased rebate as set
forth in the Note 9 Incentive will incentivize market participants to
send additional order flow to both The Nasdaq Stock Market and NOM,
which will in turn benefit all market participants on the equities and
options markets from the opportunity to interact with such order flow.
---------------------------------------------------------------------------

    \21\ See supra note 13.
---------------------------------------------------------------------------

    As discussed above, the Exchange is also proposing to increase the
Non-Penny Symbol Customer Rebate to Add Liquidity in the Note 10
Incentive from $1.05 to $1.15 per contract if the NOM Participant meets
the qualifications in note 10, including the increased NOM volume
threshold that requires NOM Participants to add Customer, Professional,
Firm, Non-NOM Market Maker and/or Broker-Dealer liquidity in Penny
Symbols and/or Non-Penny Symbols above 1.50% (increased from above
1.20%) of total industry customer equity and ETF option ADV contracts
per day in a month.\22\ While the NOM volume threshold in the Note 10
Incentive will be increased under this proposal, the Exchange believes
that the proposed increase is commensurate with the corresponding
increase in the Non-Penny Symbol Customer Rebate to Add Liquidity in
the Note 10 Incentive as described above. To the extent NOM
Participants add greater liquidity on NOM to meet the proposed volume
threshold to receive the larger rebate, the Exchange believes that its
proposal will benefit all market participants who will be able to
interact with the additional liquidity. The proposed changes to the
Note 10 Incentive are designed as a means to improve overall market
quality by providing NOM Participants with a larger incentive to
increase their provision of liquidity on the Exchange's equity and
options markets.\23\ The Exchange believes that its proposal will
continue to encourage NOM Participants to send order flow to both the
options and equity markets to receive the Note 10 Incentive.
---------------------------------------------------------------------------

    \22\ The NOM Participant will also continue to be required to
meet the following volume qualifications (in addition to the
proposed NOM volume threshold) to receive the $1.15 Non-Penny Symbol
Customer Rebate to Add Liquidity in the Note 10 Incentive: execute
greater than 0.04% of Consolidated Volume (``CV'') via Market-on-
Close/Limit-on-Close (``MOC/LOC'') volume within The Nasdaq Stock
Market Closing Cross within a month, AND add greater than 1.5
million shares per day of non-displayed volume within The Nasdaq
Stock Market within a month.
    \23\ See supra note 22.
---------------------------------------------------------------------------

    The Exchange also believes that the proposed changes to the fees
and rebates in Options 7, Section 2(1) as described above are equitable
and not unfairly discriminatory because they will apply uniformly to
all similarly situated participants. As it relates to the Non-Penny
Symbol fee increases, the Exchange will apply the increase to NOM
Market Makers, Non-NOM Market Makers, Firms, and Broker-Dealers while
Customers and Professionals will

continue to be uniformly assessed at a lower rate. The Exchange also
notes that the Note 9 Incentive and the Note 10 Incentive, each as
modified under this proposal, are available to only Customers and
Professionals. The Exchange has historically provided more favorable
pricing to both Customers and Professionals throughout its Pricing
Schedule. Furthermore, both Customer and Professional liquidity offer
benefits to the market that ultimately benefit all market participants.
Customer liquidity benefits all market participants by providing more
trading opportunities, which attracts market makers. An increase in the
activity of these market participants in turn facilitates tighter
spreads, which may cause an additional corresponding increase in order
flow from other market participants. With respect to Professionals, the
Exchange believes that continuing to encourage NOM Participants to
bring Professional order flow to NOM creates competition among options
exchanges because the more favorable pricing may cause market
participants to select NOM as a venue to send Professional order flow.
    The Exchange believes that its proposal to eliminate the Note 8
Incentive is reasonable because this rebate program has not been
successful in accomplishing its objective of incentivizing NOM
Participants to send order flow and add liquidity on the Exchange by
fortifying participation in the MARs program and the tiered Penny
Symbol Customer Rebate to Add Liquidity program. The proposed
elimination of the Note 8 Incentive will streamline the Exchange's
Pricing Schedule. The Exchange has limited resources to devote to
incentive programs, and it is appropriate for the Exchange to
reallocate these incentives periodically in a manner that best achieves
the Exchange's overall objectives to increase order flow and liquidity
on NOM. The Exchange also believes that eliminating the Note 8
Incentive is equitable and not unfairly discriminatory because the
incentive will be eliminated in its entirety and would no longer be
available to any NOM Participants.
Options 7, Section 2(3)
    The Exchange's proposal to assess a Non-Customer an increased
routing fee of $1.20 to route to another options exchange, and a
Customer a routing fee of $0.23 per contract, in addition to the actual
transaction fee assessed by the away market, for routing contracts to
any options exchange \24\ is reasonable because the proposed routing
fees would enable the Exchange to recover the costs it incurs to route
orders to away markets after taking into account the other costs
associated with routing orders to other options exchanges. In
determining its proposed routing fees, the Exchange took into account
transaction fees assessed by other options exchanges, the Exchange's
projected clearing costs, and the projected administrative, regulatory,
and technical costs associated with routing orders to other options
exchanges. Routing services offered by the Exchange are completely
optional and market participants can readily select between various
providers of routing services, including other exchanges and broker-
dealers. Also, the Exchange notes that market participants may elect to
mark their orders as ``Do-Not-Route'' to avoid any routing fees.\25\
---------------------------------------------------------------------------

    \24\ With the proposed changes, the Exchange would no longer
assess the lower routing fee of $0.13 per contract, in addition to
the actual transaction fee assessed, when routing to BX and Phlx.
    \25\ See Options 3, Section 7(c).
---------------------------------------------------------------------------

    The Exchange's proposal to assess a Non-Customer an increased
routing fee of $1.20 to route to another options exchange is equitable
and not unfairly discriminatory as all Non-Customers would be assessed
a uniform routing fee. Additionally, the Exchange's proposal to assess
a Customer a routing fee of $0.23 per contract, in addition to the
actual transaction fee assessed by the away market, for routing
contracts to any options exchange is equitable and not unfairly
discriminatory as all Customers will be uniformly assessed the same
routing fee, regardless of the destination market. Customers will
continue to receive favorable pricing as compared to other market
participants because Customer liquidity enhances market quality on the
Exchange by providing more trading opportunities, which benefits all
market participants. Finally, the Exchange notes that market
participants may elect to market orders as Do-Not-Route to avoid any
routing fees.
Technical Amendment
    The Exchange believes that its proposal to clarify that the Note 11
Incentive is available for NOM Participants that qualify for the Tier
5(b) NOM Market Maker Rebate to Add Liquidity in Penny Symbols is
reasonable because the proposal will align the rule text with the
original intent of the Note 11 Incentive and avoid any potential
confusion about the application of the Exchange's Pricing Schedule. The
Exchange also believes that its proposal is equitable and not unfairly
discriminatory because it will apply uniformly to all similarly
situated market participants. Continuing to apply the Note 11 Incentive
to only NOM Market Makers is equitable and not unfairly discriminatory
in light of their obligations on NOM (e.g., continuous quoting
obligations).

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. In terms of intra-market
competition, the Exchange does not believe that its proposal will place
any category of market participant at a competitive disadvantage. While
some aspects of the proposal apply directly to certain market
participants as described above (e.g., increased Non-Penny Symbol
Customer Rebates to Add Liquidity), Exchange believes that the changes,
taken together, will ultimately fortify and encourage activity on the
Exchange. As discussed above, all market participants will benefit from
any increase in market activity that the proposal effectuates.
    In terms of inter-market competition, the Exchange notes that it
operates in a highly competitive market in which market participants
can readily favor competing venues if they deem fee levels at a
particular venue to be excessive, or rebate opportunities available at
other venues to be more favorable. In such an environment, the Exchange
must continually adjust its fees to remain competitive with other
exchanges. Because competitors are free to modify their own fees in
response, and because market participants may readily adjust their
order routing practices, the Exchange believes that the degree to which
fee changes in this market may impose any burden on competition is
extremely limited. In sum, if the changes proposed herein are
unattractive to market participants, it is likely that the Exchange
will lose market share as a result. Accordingly, the Exchange does not
believe that the proposed changes will impair the ability of members or
competing order execution venues to maintain their competitive standing
in the financial markets.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\26\
---------------------------------------------------------------------------

    \26\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-NASDAQ-2023-044 on the subject line.

Paper Comments

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

All submissions should refer to file number SR-NASDAQ-2023-044. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (https://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-NASDAQ-2023-044 and should
be submitted on or before December 12, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\27\
---------------------------------------------------------------------------

    \27\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-25656 Filed 11-20-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 251 (Friday, December 30, 2011)]
[Rules and Regulations]
[Pages 82129-82131]
[FR Doc No: 2011-33588]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2011-D-0028]

Medical Devices; Ovarian Adnexal Mass Assessment Score Test
System; Labeling; Black Box Restrictions

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the
regulation classifying ovarian adnexal mass assessment score test
systems to restrict these devices so that a prescribed warning
statement that addresses a risk identified in the special controls
guidance document must be in a black box and must appear in all
labeling, advertising, and promotional material. The black box warning
mitigates the risk to health associated with off-label use as a
screening test, stand-alone diagnostic test, or as a test to determine
whether or not to proceed with surgery.

DATES: Effective Date: January 30, 2012.

FOR FURTHER INFORMATION CONTACT: Scott McFarland, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5543, Silver Spring, MD 20993-0002, (301)
796-6217.

SUPPLEMENTARY INFORMATION:

I. What is the background of this final rule?

A. Ovarian Adnexal Mass Assessment Score Test System

    An ovarian adnexal mass assessment score test system is a device
that measures one or more proteins in serum or plasma. It yields a
single result for the likelihood that an adnexal pelvic mass in a woman
for whom surgery is planned, is malignant. The test is for adjunctive
use, in the context of a negative primary clinical and radiological
evaluation, to augment the identification of patients whose gynecologic
surgery requires oncology expertise and resources.

B. Identified Risk to Health

    The ovarian adnexal mass assessment score test system is not
indicated for use as a screening or diagnostic test for ovarian cancer.
Off-label use of the test (e.g., in patients who are not already
identified as needing surgery for pelvic mass or without reference to
an independent clinical/radiological evaluation of the patient), may
lead to a high frequency of unnecessary further testing and surgery due
to false positive results, or to delay in tumor diagnosis due to false
negative results.

II. Why is FDA requiring black box warnings on ovarian adnexal mass
assessment score test system labeling, advertising, and promotional
material?

    FDA has determined that in order to provide reasonable assurance of
safety and effectiveness, it is necessary to restrict the ovarian
adnexal mass assessment score test system to sale, distribution, and
use with labeling, advertising, and promotional material that bears a
warning statement in a black box that alerts users to the risk
associated with off-label use as a screening test, stand-alone
diagnostic test, or as a test to determine whether or not to proceed
with surgery. In the Federal Register of March 23, 2011 (76 FR 16292 at
12694), FDA published a final rule that classified this device into
class II and established as a special control the guidance entitled
``Class II Special Controls Guidance Document: Ovarian Adnexal Mass
Assessment Score Test System'' that recommends a black box warning to
address the risk of off-label use. In the Federal Register of March 23,
2011 (76 FR 16425), FDA published a notice of availability of this
special controls guidance document. However, FDA believes it is
necessary to require this warning in labeling and advertising by
restricting the device under section 520(e) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(e)). In the Federal
Register of March 23, 2011 (76 FR 16350 at 16352), FDA published a
proposed rule to require the black box warning.
    For devices that have significant risks that would make the devices
unsafe if used inappropriately, FDA may require that the risks be
explained in warning statements placed in a black box that is displayed
prominently in the labeling, advertising, and promotional material to
ensure awareness by the end user. Awareness of these important risks by
the end user enables these devices to be used safely. In this case, a
prominent black box warning, which alerts the user to the limitations
of this device, is necessary in all labeling, advertising, and
promotional materials to allow ovarian adnexal mass assessment score
test system devices to be used safely. The prominent black box warning
must read as follows:

[GRAPHIC] [TIFF OMITTED] TR30DE11.007

III. What comments did FDA receive on this rule?

    In the Federal Register of March 23, 2011 (76 FR 16350 at 16352),
FDA announced the proposed rule to require the black box warning.
Comments on the proposed rule were due by May 23, 2011. FDA received
one comment in the docket for the proposed rule from a consumer. The
comment supported the proposed rule.

IV. What is the legal authority for this final rule?

    FDA is issuing this final rule under the authority of section
520(e) of the FD&C Act, which authorizes FDA to restrict sale,
distribution, and use of devices upon certain conditions. FDA is also
issuing this final rule under general device and administrative
provisions of the FD&C Act (sections 501, 510, 513, 515, 520, and 701
(21 U.S.C. 351, 360, 360c, 360e, 360j, and 371, respectively)).

V. What is the environmental impact of this final rule?

    FDA has determined under 21 CFR 25.34(b) and (f) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

VI. What is the economic impact of this final rule?

    FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this final rule is not a significant
regulatory action under Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this final rule strengthens existing
cautions against misuse of a product, the Agency certifies that the
final rule will not have a significant economic impact on a substantial
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $136 million, using the most current (2010) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
    An ovarian adnexal mass assessment test system is a device that
measures one or more proteins in serum to yield a single result for the
likelihood that an adnexal pelvic mass in a woman is malignant. Such a
test would identify women whose planned gynecologic surgery would
benefit from referral to a gynecological oncologist, despite negative
results from other clinical and radiographic tests for ovarian cancer.
    In considering the appropriate level of regulatory oversight for
this device, FDA concluded in classifying the device that general and
special controls to minimize the risk of false positive and false
negative results, and risks associated with improper off-label use
would provide a reasonable assurance of safety and effectiveness of the
ovarian adnexal mass assessment test system. The special controls
guidance recommends use of a black box warning to minimize these risks.
Without such a strong warning, ovarian adnexal mass assessment test
systems might be used as a screening test, stand-alone diagnostic test,
or as a test to determine whether or not to proceed with surgery. Off-
label use of the test or the use of test results without consideration
of other diagnostic testing and clinical assessment could pose a risk
for morbidity and mortality due to nonreferral for oncologic evaluation
and treatment.
    In order to require the specific black box warning on labeling and
on all advertising and promotional materials for the device, FDA is
issuing this final rule under section 520(e) of the FD&C Act. Through
this action, the Agency requires a black box warning on product
labeling, advertising, and promotional materials for ovarian adnexal
mass assessment test systems. This warning will make users aware of the
limitations of this device and the serious risks associated with its
misuse. With the addition of this black box warning to product
labeling, advertising, and marketing materials, the Agency concludes
there will be a reasonable assurance of the safety and effectiveness of
ovarian adnexal mass assessment test systems.
    The economic impact of this final rule is expected to be very
small. We are aware of a single manufacturer producing a single product
that will be affected by this black box warning. The manufacturer
should be able to incorporate the warning in the course of developing
its product labeling. The admonition against off-label use for this
device already exists, so the addition of this type of warning is not
expected to have a significant effect on the market for this product.
The expected impact of this final rule on the market for this product
would be a reduction in off-label use among the small number of users
who would be undeterred by a less visible warning.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any

significant impact of a rule on small entities. This final rule would
impose almost no cost on manufacturers. The black box warning will
strengthen an existing admonition against off-label use and will not
significantly affect usage. Impacts on any entities will be so small as
to be difficult to quantify. For these reasons, the Agency certifies
that this rule will not have a significant economic impact on a
substantial number of small entities.

VII. How does the Paperwork Reduction Act of 1995 apply to this final
rule?

    FDA concludes that labeling provisions of this final rule are not
subject to review by the Office of Management and Budget because they
do not constitute a ``collection of information'' under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the black box
warning on all labeling, advertising, and promotional materials for
ovarian adnexal mass assessment score test system devices is a ``public
disclosure of information originally supplied by the Federal Government
to the recipient for the purpose of disclosure to the public.'' (see 5
CFR 1320.3(c)(2)).

VIII. What are the federalism impacts of this final rule?

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires Agencies to ``construe * * * a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' Federal law includes an express preemption provision
that preempts certain State requirements ``different from or in
addition to'' certain Federal requirements applicable to devices (21
U.S.C. 360k; See Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996); Riegel
v. Medtronic, Inc., 552 U.S. 312 (2008)). This final rule creates a
requirement under 21 U.S.C. 360k for a black box warning statement that
must appear in all advertising, labeling, and promotional material for
ovarian adnexal mass assessment score test systems.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, FDA amends
21 CFR part 866 as follows.

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for 21 CFR part 866 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. In Sec.  866.6050 of subpart G, add new paragraph (c) to read as
follows:

Sec.  866.6050  Ovarian adnexal mass assessment score test system.

* * * * *
    (c) Black box warning. Under section 520(e) of the Federal Food,
Drug, and Cosmetic Act these devices are subject to the following
restriction: A warning statement must be placed in a black box and must
appear in all advertising, labeling, and promotional material for these
devices. That warning statement must read:
[GRAPHIC] [TIFF OMITTED] TR30DE11.007

    Dated: December 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33588 Filed 12-29-11; 8:45 am]
BILLING CODE 4160-01-P