[Federal Register Volume 76, Number 149 (Wednesday, August 3, 2011)]
[Notices]
[Page 46793]
[FR Doc No: 2011-19633]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER11-2875-001; ER11-2875-002; Docket No. EL11-20-001]

PJM Interconnection, L.L.C.; PJM Power Providers Group v. PJM
Interconnection, L.L.C.; Notice Establishing Post-Technical Comment
Period

    As indicated in the June 29, 2011 Notice in these dockets, comments
on the technical conference that was held on July 28, 2011, to discuss
issues related to PJM Interconnection, L.L.C. (PJM)'s Minimum Offer
Price Rule (MOPR) and resources designed as ``self supply,'' \1\ are
due 21 days from the date of this conference, or Thursday, August 18,
2011.
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    \1\ PJM Interconnection, L.L.C., 135 FERC ] 61,228 (2011).

    Dated: July 28, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-19633 Filed 8-2-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 24 (Wednesday, February 5, 2014)]
[Rules and Regulations]
[Pages 6819-6826]
[FR Doc No: 2014-02294]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 152

[EPA-HQ-OPP-2009-0456; FRL-9904-32]
RIN 2070-AJ58

Pesticides; Satisfaction of Data Requirements; Procedures To
Ensure Protection of Data Submitters' Rights

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is revising and updating its regulations governing the
procedures for the satisfaction of data requirements under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). Specifically, this
regulation addresses procedures for the protection of exclusive use and
data compensation rights of data submitters, which have not been
revised since issuance in 1984. These revisions are now needed to
accommodate statutory changes and related changes in practice that have
occurred since that time and to make minor changes to clarify the
regulations.

DATES: This final rule is effective April 7, 2014.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2009-0456, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave., NW., Washington, DC 20460-0001. 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 OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Scott Drewes, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. What action is the agency taking?

    EPA is revising and updating its regulations governing the
procedures for the satisfaction of data requirements under FIFRA.
Specifically, these provisions include procedures for the protection of
exclusive use and data compensation rights of data submitters. These
revisions also provide greater clarity when data compensation
procedures do and do not apply, and update the regulations to be
consistent with statutory changes and related changes in practice since
the regulations were first promulgated in 1984.

B. What is the agency's authority for taking this action?

    This action is issued under the authority of FIFRA sections 3 and
25, 7 U.S.C. 136 et seq.

C. Does this action apply to me?

    You may be potentially affected by this action if you produce
pesticide products that require registration with EPA. The following
list of North American Industrial Classification System (NAICS) codes
is not intended to be exhaustive, but rather provides a guide to help
readers determine whether this document applies to them. Potentially
affected entities may include, but are not limited to: Pesticide and
other agricultural chemical manufacturing (NAICS code 325320), e.g.,
pesticides manufacturing, insecticides manufacturing, herbicides
manufacturing, fungicides manufacturing, etc.

D. What are the incremental costs and benefits of this action?

    EPA did not quantify the potential costs or benefits from these
revisions, which are qualitatively discussed in Unit V. EPA has
determined that there are minimal incremental costs for industry to
comply with the requirement that applicants submit data compensation
materials at the time of application for registration. As such, EPA has
concluded that the per firm and industry level impact of the rule is
not significant. Benefits are derived from the efficiencies in the
registration process gained by the timely submission of data
compensation materials to EPA, as well as the early resolution of data
compensation disputes that may arise. EPA also believes benefits accrue
to applicants through the additional clarity regarding when data
compensation procedures do not apply.

II. Background

A. Summary of the Proposed Rule

    In the Federal Register of November 5, 2010 (75 FR 68297) (FRL-
8424-8), EPA proposed to revise the regulations governing procedures
for the satisfaction of data requirements under

FIFRA. EPA proposed to do the following:
     Replace the limited listing of actions to which subpart E
does not apply with a single reference to actions that may be
accomplished by notification or non-notification under Sec.  152.46;
     Update and restructure the existing definition of
exclusive use period to incorporate the additional exclusive use
criteria added by the Food Quality Protection Act (FQPA) of 1996;
     Revise Sec.  152.84 to conform to the requirements of
FIFRA section (33)(f), which now requires data compensation materials
to be submitted at the time of application; and
     Update the regulations to be consistent with programmatic
developments since the regulations were first promulgated in 1984,
including eliminating the data gap procedures, removing the reference
to Registration Standards, and adding email as a means of contacting
data submitters.

B. Public Comments and EPA Responses

    EPA has considered the comments received on the proposed rule, and
provided responses in a Response to Comments document, which is
available in the docket for this rulemaking. Many commenters requested
the Agency to make additional revisions that were outside the scope of
the proposed rule. Only the key comments within the scope of the
proposed rule and the Agency's responses are discussed in this
document.
    1. Data submitters rights under a Data Call-In (DCI). Two
commenters questioned how data submitters' rights would be addressed
under a DCI. EPA proposed to specify in the applicability section of
the regulation at 40 CFR 152.81(a)(3) that when a DCI itself
establishes procedures for the protection of data rights, recipients of
the DCI must follow the procedures established in the DCI rather than
the procedures set forth in subpart E. The commenters argued that the
proposed revisions would nullify the protections afforded by the
administrative process used to develop subpart E and could result in
the establishment of arbitrary procedures.
    In response, EPA notes that the Agency did not intend to suggest
that the data protections of FIFRA section 3(c)(1)(F) do not apply to
data submitted in response to a DCI. The purpose of the proposed
amendment to Sec.  152.81(a)(3) was to clarify and codify the Agency's
existing practices for ensuring protection of data rights in connection
with the issuance of DCIs. EPA's intent in adding the reference to
FIFRA section 3(c)(2)(B) was simply to make clear that DCIs are actions
subject to the data compensation provisions of FIFRA and to acknowledge
that EPA, pursuant to its authority under FIFRA section 3(c)(2)(B),
generally establishes compliance procedures in the DCIs it issues. EPA
believes it is generally simpler and more efficient to include
provisions for the protection of data in the DCIs themselves in order
to provide recipients with a single set of instructions for satisfying
the terms of a DCI. Further, because the process and timing for
complying with DCIs under FIFRA section 3(c)(2)(B) differs from the
process for obtaining a new registration, EPA believes it generally
makes sense to tailor the instructions for addressing the data
protection requirements of FIFRA to fit the structure of the DCI
compliance process. As a practical matter, the procedures EPA
establishes for the protection of data rights in DCIs track those in
subpart E because, as the commenter points out, the protections of
FIFRA section 3(c)(1)(F) apply with equal force to data submitted under
FIFRA section 3(c)(2)(B). Thus, this provision does not have any
substantive impact on the protection EPA extends to data submitted to
the Agency under FIFRA.
    2. List of amendments excluded from the scope of subpart E. A
commenter asked the Agency to provide a single source of current,
appropriately updated and readily available guidance that specifies
actions that do not require compliance with subpart E.
    In response, EPA notes that it proposed to revise Sec.  152.81(b)
by removing the list of amendments in Sec.  152.81(b)(4) that do not
require compliance with subpart E and instead refer to the notification
and non-notification provisions of Sec.  152.46. Through proposed Sec.
152.81(b)(6), however, EPA retains its ability to exclude from the
provisions of subpart E ``any type of amendment if the Administrator
determines, by written finding, that Agency consideration of data would
not be necessary in order to approve the amendment under FIFRA section
3(c)(5).''
    The proposed revisions to Sec.  152.81(b) would not change the
scope of subpart E. As EPA explained in the preamble to the proposed
amendments, data submission obligations--and therefore compliance with
the data protection procedures of the subpart E regulations--only apply
where review of an application requires EPA consideration of scientific
data in order to make a FIFRA regulatory determination. Because it
would be difficult to create an exhaustive list of possible
registration amendment actions that do not require review of data, EPA
believes it is simpler and less confusing to make that principle clear
in the regulations without also including what, in the existing
regulations, was a non-exhaustive list of such amendments. Further, EPA
believes the regulation's express exclusion of registration amendments
subject to the notification and non-notification provisions of Sec.
152.46 from these data protection procedures effectively addresses the
majority of amendment actions not requiring consideration of scientific
data. A list of those actions can be found in Pesticide Registration
(PR) Notice 98-10, available on the Internet at http://www.epa.gov/PR_Notices/pr98-10.pdf. PR Notice 98-10 was developed pursuant to Sec.
152.46 specifically to identify minor registration amendments that may
be made by notification or non-notification without the need for Agency
review of scientific data and are, therefore, not subject to the
subpart E data protection procedures. EPA believes it is appropriate to
address other circumstances where scientific review of data is not
required on a case-by-case basis in connection with specific amendment
requests. EPA is finalizing the language in Sec.  152.81(b) as
proposed.
    3. Authorization for use of exclusive use studies for tolerances or
tolerance exemptions. A commenter proposed that EPA require applicants
to submit authorizations for use of exclusive use studies to the Agency
prior to registration or the Agency's granting of a tolerance or
tolerance exemption if the Agency identifies any exclusive use data
submitted on the Data Submitter's List.
    In response, EPA notes that the regulations at Sec. Sec.  152.86(a)
and 152.93(b) already require applicants for FIFRA registration to
certify prior to registration that they have obtained permission for
the citation of any exclusive use studies. EPA believes that the
certification process under those provisions has been effective in
ensuring that necessary authorizations have been obtained and there is
no need to require submission of the actual documentation to EPA.
    EPA notes that the commenter's request to extend the proposal to
apply to the issuance of tolerances and tolerance exemptions goes
beyond the scope of EPA's proposal. EPA did not propose to make changes
to the portion of the regulations addressing the types of regulatory
approvals that are subject to the subpart E procedures. This comment
therefore goes beyond the scope of EPA's proposal.

    In 2003, EPA addressed the substance of this comment when it
announced in the Federal Register of April 17, 2003 (68 FR 18977) (FRL-
7279-9) the availability of a white paper, ``Proposal for Implementing
Data Compensation Rights for Data Submitted in Support of Tolerance or
Tolerance Exemption Actions,'' discussing a program to enable the
Agency to appropriately implement the new provisions contained in
section 408(i) of the Federal Food, Drug, and Cosmetic Act (FFDCA) to
address exclusive use and compensation rights for data submitted to EPA
in support of tolerance and tolerance exemption actions. In that white
paper, EPA made clear that FFDCA section 408(i) extends exclusive use
and data compensation rights to data submitted to support or maintain
tolerances and tolerance exemptions to the same extent provided by
FIFRA section 3. It is, however, important to understand how and when
FFDCA data are protected by EPA. While FFDCA section 408(i) bestows
protections to data submitted under FFDCA, EPA protects those rights
through the FIFRA registration process when an application for a
pesticide registration is submitted, not when a tolerance or tolerance
exemption is sought. Tolerances and tolerance exemptions are rulemaking
actions, not licenses issued to individuals that sell or distribute
pesticides or pesticide ingredients. Unlike FIFRA, the FFDCA rulemaking
process does not, therefore, provide EPA with a means of ensuring
compliance with exclusive use and compensation requirements by all
persons who may sell or distribute a product that is covered by a
tolerance or tolerance exemption. For this reason, EPA ensures
compliance with exclusive use and data compensation obligations in
connection with the submission of an application for registration or
amended registration under FIFRA and not in connection with the
issuance of a FFDCA tolerance or tolerance exemption.
    4. When materials must be submitted. Several commenters addressed
EPA's proposal to amend Sec.  152.84 to require submission of all data
compensation compliance information and materials, including evidence
of any necessary offers to pay compensation, at the time of application
rather than ``at any later time prior to EPA's approval of the
application.''
    In response, EPA notes that the commenters were split regarding
EPA's proposal to require submission of all data compliance information
and materials at the time of application. As EPA explained in the
preamble to the proposed rule, the Agency proposed this change to
conform the implementing regulations with the requirements of FIFRA
section 33(f)(4) (as amended by the Pesticide Registration Improvement
Renewal Act (PRIA II), Pub. L. 110-94, commonly called PRIA II).
Because FIFRA section 33(f)(4)(B) directs EPA to determine during the
initial screen (within 21 days after receiving the required
registration service fee) that ``the application contains all the
necessary forms, data, and draft labeling,'' EPA believes that
completed data citation forms must be submitted at the time of
application. In addition, EPA also cited a policy rationale in support
of this proposed amendment, noting that the Agency's primary rationale
for previously allowing data compensation materials to be submitted
after submission of the application--the time-consuming data gap
certification process--was being eliminated from the regulations.
    The commenters objecting to EPA's proposal argued that, contrary to
EPA's position, FIFRA section 33(f)(4) leaves EPA with discretion to
determine what contents of the application constitute a ``complete
application.'' They also argued that the Agency's ability to conduct
reviews of applications would not be limited in any way by allowing
applicants to submit offers to pay throughout the application review
process. This group of commenters' primary concern with the proposed
change appeared to be that it may provide a greater opportunity for
data submitters to seek compensation and file data compensation
petitions before uncertainties involving EPA's ``substantial
similarity'' determinations and related data issues have been resolved.
To that end, these commenters asked that EPA maintain the current
language, or that EPA consider an alternative to the proposed amendment
whereby applicants would be required to provide notice to data
submitters of their intent to file applications for registration, but
would not be compelled to tender any associated offers to pay
compensation unless and until EPA reviewed and accepted the applicant's
citations to data. They argued that this alternative would not delay
EPA's review, since review of the offer to pay certification is merely
an ``administrative function'' and they asserted that this alternative
could minimize unnecessary and premature data compensation disputes.
    The commenters supporting EPA's proposed amendment agreed with
EPA's interpretation of PRIA II that completed data compensation
materials must be submitted as part of the initial application. They
also argued that allowing applicants to delay submitting required
offers ``until the eve of registration'' effectively reads the right to
petition to deny an application out of EPA's regulations and deprives
EPA of the assistance of the original data submitter in meeting EPA's
obligation to determine that the applicant has submitted or cited all
necessary data, consistent with the requirements of FIFRA section
3(c)(1)(F) and Sec. Sec.  152.80 through 152.99.
    EPA continues to believe that Congress clearly addressed this issue
with the passage of PRIA II and must therefore reject those comments
seeking that EPA maintain Sec.  152.84 in its current form. There is no
dispute that FIFRA section 3(c)(1)(F) requires applicants for
registration or amended registration to offer to pay compensation to
original data submitters when the application seeks to rely on
previously submitted data that are subject to FIFRA compensation
requirements. EPA requires applicants to submit a data certification
form to demonstrate that any required offer to pay compensation has
been made. There can be little question, therefore, that the data
certification form is a ``necessary form'' within the meaning of FIFRA
section 33(f)(4)(B) and that, consistent with the requirements of that
section, these forms must be submitted at the time of application.
    With the recent passage of the Pesticide Registration Improvement
Act of 2012 (Pub. L. 112-177), Congress has only made it more clear
that a completed data certification form must be submitted at the time
of application. Specifically, FIFRA section 33(f)(4)(B)(iv)(II) now
expressly provides that an application is only considered complete for
purposes of the preliminary technical screening required by FIFRA
section 33 if the Administrator determines that ``the application,
data, or information are consistent with the proposed labeling and any
proposal for a tolerance or exemption from the requirement of a
tolerance . . . and are such that, subject to full review under the
standards of this Act, could result in the granting of the
application.'' (emphasis added). Since EPA cannot lawfully grant an
application in the absence of ensuring that an applicant has made all
necessary offers to pay or received any required letters of
authorization to cite data, it is clear that EPA cannot consider as
complete applications that do not include a completed data
certification form. Consistent with the requirements of FIFRA section
33(f)(4)(B)(ii), EPA is required to reject applications that do not
include completed data certification

forms and therefore cannot permit applicants to submit certifications
``at any later time prior to the approval of the application,'' as
previously provided in Sec.  152.84.
    Further, even if EPA had discretion to consider the alternative
approach offered by the commenters, EPA does not believe that approach
promotes the efficient and effective review of applications. The notion
that certain portions of applications should continue to come in
piecemeal to EPA is not consistent with the prompt and efficient FIFRA
application process envisioned by PRIA. In addition, ensuring that all
necessary offers to pay are made is not simply an ``administrative
function,'' but an obligation that lies at the core of EPA's duty to
ensure compliance with the data protection provisions of FIFRA section
3(c)(1)(F). EPA believes that providing data submitters with the
required offers to pay at the beginning of the application process
rather than at the end of that process can serve to assist EPA in
ensuring that the Agency meets its FIFRA section 3(c)(1)(F) obligations
and can serve to encourage early resolution of data compensation
disputes. While EPA understands the reasoning why some commenters would
prefer to engage in those disputes after an application has been
granted rather than before, EPA does not believe this is a policy
objective reflected in FIFRA, nor was it EPA's objective when it
promulgated the original regulation that allowed data compensation
materials to be submitted after the initial application. The basis for
that provision was largely to avoid the delay applicants could
encounter as a result of the data gap certification process. And, as
noted, EPA has eliminated the data gap process with these amendments.
    5. Electronic means of contacting data submitters. Two commenters
sought clarification as to whether the proposal to require offers to
pay to include the applicant's email address applied to data
submitters, as the title of this section in the preamble to the
proposed rule might have suggested, or whether it was meant to apply
only to applicants that are submitting offers to pay compensation. The
commenters further asserted that they believe that it would not be
appropriate or sufficient to allow electronic notification as the sole
method of delivering offers to pay data submitters.
    In response, EPA notes that the provision proposed in Sec. Sec.
152.86 and 152.95 that creates a requirement to include an email
address as an additional point of contact is part of the ``offer to
pay'' requirement that is applicable to applicants, not to data
submitters. EPA agrees that the title of this section in the preamble
of the proposed rule may have created some confusion, but EPA believes
the proposed provisions of the rule are clear that the obligation to
provide an email address is part of the offer to pay requirement. EPA
also notes that it inadvertently omitted this language from the offer
to pay provision in proposed Sec.  152.93(b)(2)(v) and has included it
in the final rule.
    In response to the commenters' final point, it was not EPA's intent
in the proposed rule to prescribe or limit the means by which an
applicant delivers offers to pay to data submitters and the regulations
in subpart E have not limited the forms of delivery that may be used.
EPA recognizes the efficiencies afforded by email, and the Agency
believes that, given advances in technology, it would be inappropriate
to preclude email as a means of communication between applicants and
data submitters, including submission of offers. Provided the applicant
can produce evidence of delivery of the offer to the original data
submitter, EPA does not believe FIFRA prescribes a precise method of
delivery.
    Consistent with this view, in this final rule EPA is amending the
language in Sec.  152.99(b)(2) requiring that data compensation
petitions be sent by certified mail, to allow the use of any method
that provides evidence of delivery.
    6. Source of list of data requirements. Several commenters
requested EPA to clarify when Reregistration Eligibility Decision
documents (REDs) and registration review decision documents can be
relied on to determine registration data requirements and to determine
what data are compensable.
    In response, EPA notes that the Agency proposed in the November 5,
2010 Federal Register document to eliminate from Sec.  152.90(a) the
requirement that an applicant use an issued Registration Standard, the
EPA reregistration decision documents issued prior to 1988, as the
source of its list of data requirements for the selective method.
Further, Sec.  152.90(a) indicated that if the Registration Standard
does not address all required data or there is no Registration
Standard, the applicant must refer to the data requirements in 40 CFR
part 158 as the alternate source of its list of data requirements.
    As explained in the preamble to the proposed rule, the form of EPA
decision documents has evolved since the 1984 regulations were
promulgated. Registration Standards were superseded beginning in 1988
by REDs as the Agency implemented the reregistration requirements of
FIFRA section 4. In turn, REDs will likely be superseded or updated by
determinations made under the registration review program required by
FIFRA section 3(g) and 40 CFR part 155. Given the growth and evolution
of the program's systematic review of existing pesticides, EPA
explained that it no longer intends to identify by regulation a
specific type of decision document as the source of data requirement
listings. These documents are a snapshot of the data requirements at a
particular review period, and are likely to become outdated over time
as EPA's risk assessments evolve and new types of data are needed.
Accordingly, the Agency concluded that Sec.  152.90(a)(2) should be
revised to require applicants to list the applicable EPA data
requirements at 40 CFR part 158.
    The commenters expressed concern that this amendment could be
interpreted to allow selective citations to exclude data requirements
that are not explicitly included in EPA's codified data requirements
but that may have otherwise been required in connection with
registration, reregistration, or registration review actions and
reflected in Agency decision documents such as REDs. The commenters,
therefore, asked EPA to reinforce that its data regulations are
flexible and that the Agency can and often does impose additional
requirements beyond those found explicitly in the data tables. EPA
agrees with these comments, but does not believe there is any need to
alter the language of the amendment as proposed. It was not EPA's
intention to suggest that in all cases the data tables in 40 CFR part
158 will constitute the exclusive list of required data that applicants
utilizing the selective method of citation must satisfy. In fact, EPA's
data regulations make it explicitly clear that the regulations are
intended to be flexible and that EPA reserves the right to require
additional data, or, in some instances, to waive studies that EPA
concludes are not relevant to its registration decision under FIFRA. It
is EPA's intention that the reference to 40 CFR part 158 in amended
Sec.  152.90(a)(2) incorporate this principle. Accordingly, where EPA
has imposed additional requirements beyond those listed in the 40 CFR
part 158 data tables, applicants will be required to satisfy those
requirements, consistent with the requirements of subpart E.
Conversely, where EPA determines that a requirement can be waived or
that

alternative information to that listed in the data tables can serve to
satisfy the data requirement, applicants will not be required to
satisfy the requirements as set forth in the data tables. As noted in
the preamble, given the flexibility of the data regulations, documents
such as REDs will continue to provide useful guidance to applicants and
registrants in determining how EPA has applied the data requirements to
individual products and uses.
    7. Elimination of certification and documentation procedures for
data gaps. One commenter noted that, in the preamble to the proposed
rule, the Agency states that a data submitter would no longer routinely
receive requests from applicants to confirm a data gap, but that, under
Sec.  152.119 the Agency ``will make available 30 days after
registration the means by which an applicant satisfied the data
requirements, including whether, under the selective method, the
applicant claimed a data gap.'' The commenter contended that this puts
a burden upon data submitters to search for Agency actions that may be
affected. Further, the commenter questioned how the Agency proposes to
make such information available and whether the information will be
available for all applications for new or amended registrations that
rely upon the selective method or only for certain ones.
    In response, EPA notes that while it is true that in the absence of
receiving a data gap letter, the data submitter will not necessarily
know at the time of application whether the applicant is claiming that
a data gap exists, EPA believes there are numerous means to ensure
protection of a data submitter's interest in compensable data should an
applicant incorrectly assert that a data gap exists. First, as noted in
the preamble to the proposed rule, with the completion of
reregistration and the development of REDs for all pesticides that list
by guideline the data received and reviewed by EPA, the Agency is now
in a far better position to evaluate the legitimacy of data gap claims
than it was when it issued the existing data compensation regulations
in 1984. Second, data submitters will often have prior notice that an
applicant is seeking registration when they receive offers to pay
compensation for any data for which a data gap is not claimed. If they
believe the offer to pay they receive should also extend to previously
submitted studies not included in the offer, the data submitter can
file a petition to deny the application under Sec.  152.99. Finally,
once a registration is issued, the data submitter may obtain a copy of
any applicant's data compliance materials through the Freedom of
Information Act, as provided in Sec.  152.119 and consistent with EPA's
information regulations at 40 CFR part 2. With that information, the
data submitter can then file a petition to cancel under Sec.  152.99 if
the data submitter believes the Agency improperly accepted the
applicant's data gap claim in lieu of citing data belonging to the data
submitter.

III. The Final Rule

    With the exception of the modifications discussed in the Unit
II.B., EPA is finalizing the rule in essentially the same form as the
proposed rule. The final rule does the following:
     Provides greater clarity when data compensation
requirements do not apply by highlighting actions that do not require a
scientific review of data and thus do not require satisfaction of data
requirements;
     Updates the definition of an ``exclusive use study'' to
incorporate the additional exclusive use criteria added by the FQPA;
     Conforms to the requirements of FIFRA section 33(f)(4), as
most recently amended by PRIA II, by requiring applicants to submit
data compensation materials at the time of application;
     Removes the outdated requirement that applicants use a
Registration Standard for determining which data requirements need to
be satisfied for a particular pesticide; instead, applicants will
simply be directed to the data requirement listings in 40 CFR part 158;
and
     Updates the regulations to be consistent with Agency
practices since the regulations were first promulgated in 1984.

IV. FIFRA Review Requirements

    In accordance with FIFRA sections 25(a) and (d), the Agency
submitted a draft of this final rule to the appropriate Congressional
Committees, the Secretary of Agriculture, and the FIFRA Scientific
Advisory Panel (SAP). The SAP and the Secretary of Agriculture waived
review of this rule.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    On May 5, 2011, the Office of Management and Budget (OMB)
determined that this action is not a ``significant regulatory action''
under the terms of Executive Order 12866 (58 FR 51735, October 4,
1993), and is therefore not subject to review by OMB under Executive
Orders 12866 and 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burdens
that require additional review or approval by OMB under PRA, 44 U.S.C.
3501 et seq. Burden is defined at 5 CFR 1320.3(b). 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 displayed in the Federal Register and are listed in 40 CFR part 9.
    The information collection requirements contained in this rule are
already approved by OMB under OMB control numbers 2070-0060 (EPA ICR
No. 0277) and 2070-0174 (EPA ICR No. 2288.01). Since there is no new
burden, it was not necessary to amend the Information Collection
Requests (ICRs).

C. Regulatory Flexibility Act (RFA)

    Pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), after
considering the potential economic impacts of this rule on small
entities, the Agency hereby certifies that this action will not have a
significant adverse economic impact on a substantial number of small
entities. For purposes of assessing the impacts of this rule on small
entities, a small entity is defined as:
    1. A small business as defined by the Small Business
Administration's (SBA) regulations at 13 CFR 121.201.
    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.
    3. A small organization that is any not-for-profit enterprise which
is independently owned and operated and is not dominant in its field.
    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 rule on small entities'' (5 U.S.C. 603 and 604).
Thus, an agency may certify 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.

    EPA believes that the final rule would not have any adverse impacts
on affected small entities, because the revisions are of minimal impact
and do not increase activities or related burden. The revisions change
the timing, but do not alter the substance of the existing pesticide
data submission or citation obligations. The revisions are expected to
simplify the procedures for the satisfaction of data requirements.
Further, small business entities already receive the benefit of the
statutory ``formulators' exemption'' provision which exempts qualifying
applicants and registrants from most data submission and citation
obligations. EPA has therefore concluded that the final rule will not
have any adverse impacts on affected small entities.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of UMRA (2 U.S.C. 1531-
1538). Therefore, this action is not subject to the requirements of
UMRA.

E. Executive Order 13132: Federalism

    This action does not have a 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 (64
FR 43255, August 10, 1999). Since States or local governments are
rarely pesticide applicants or registrants, this final rule may seldom
affect a State or local government. Thus, Executive Order 13132 does
not apply to this rule.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications because it does not
have any effect on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes.
Accordingly, the requirements of Executive Order 13175 (65 FR 67249,
November 9, 2000) do not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it is not an economically significant
regulatory action as defined by Executive Order 12866, nor does it
establish an environmental standard that is intended to mitigate health
or safety risks, nor would it otherwise have a disproportionate effect
on children.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This final rule is not subject to Executive Order 13211 (66 FR
28355, May 22, 2001) because it is not likely to have any adverse
effect on the energy supply, distribution, or use of energy.

I. National Technology Transfer and Advancement Act (NTTAA)

    This final rule does not impose any technical standards that would
require Agency consideration of voluntary consensus standards provided
in section 12(d) of the NTTAA, 15 U.S.C. 272 note.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations. This rule only impacts
entities that intend to register or currently hold registrations for
pesticides. It does not involve special consideration of any
environmental justice related issues as delineated by Executive Order
12898 (59 FR 7629, February 16, 1994).

VI. Congressional Review Act (CRA)

    Pursuant to the CRA, 5 U.S.C. 801 et seq., 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.
This action is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 152

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

    Dated: January 27, 2014.
James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.

    Therefore, 40 CFR part 152, subpart E is amended as follows:

PART 152--PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES

0
1. The authority citation for part 152 continues to read as follows:

    Authority: 7 U.S.C. 136-136y; Subpart U is also issued under 31
U.S.C. 9701.

0
2. Revise the heading of subpart E to read as follows:

Subpart E--Satisfaction of Data Requirements and Protection of Data
Submitters' Rights

0
3. Revise Sec.  152.81 to read as follows:

Sec.  152.81  Applicability.

    (a) Except as provided in paragraph (b) of this section, the
requirements of this subpart apply to:
    (1) Each application for registration of a new product.
    (2) Each application for amended registration of a currently
registered product.
    (3) Each submission in response to a Data Call-In under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(c)(2)(B)
for an existing registration, including but not limited to, a product
subject to reregistration under FIFRA section 4 or registration review
under FIFRA section 3(g). If the Data Call-In establishes procedures
for protection of data submitters' rights, recipients must comply with
the specific requirements of the Data Call-In rather than the generic
procedures set forth in Sec. Sec.  152.85 through 152.96.
    (b) This subpart does not apply to any of the following:
    (1) An application for registration submitted to a State under
FIFRA section 24(c).
    (2) An application for an experimental use permit (EUP) under FIFRA
section 5.
    (3) An application for an emergency exemption under FIFRA section
18.
    (4) A request for cancellation of a registration, or a request for
deletion of one or more existing uses, under FIFRA section 6(f).
    (5) A modification to registration of a currently registered
product that may be accomplished under the notification or non-
notification provisions of Sec.  152.46 and any procedures issued
thereunder. Notwithstanding the preceding sentence, compliance with
this subpart is required if the Administrator has, by written notice
under Sec.  152.46, determined that the modification may not be
accomplished by notification or non-notification.
    (6) Any type of amendment if the Administrator determines, by
written

finding, that Agency consideration of data would not be necessary in
order to approve the amendment under FIFRA section 3(c)(5).
    (7) Compliance with Agency regulations, adjudicatory hearing
decisions, notices, or other Agency announcements that unless the
registration is amended in the manner the Agency proposes, the
product's registration will be suspended or canceled, or that a hearing
will be held under FIFRA section 6. However, this paragraph does not
apply to amendments designed to avoid cancellation or suspension
threatened under FIFRA section 3(c)(2)(B) or because of failure to
submit data.

Sec.  152.83  [Redesignated as Sec.  152.82]

0
4. Redesignate Sec.  152.83 as Sec.  152.82.
0
5. Amend newly redesignated Sec.  152.82 by revising the introductory
text and removing the definition for ``Exclusive use study''.
    The amendments read as follows:

Sec.  152.82  Definitions.

    For the purposes of this subpart, the definitions set forth in the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), in Sec.
152.3, and in this section apply. In addition, the term ``exclusive use
study'' shall have the meaning set forth in Sec.  152.83.
* * * * *

0
6. Add Sec.  152.83 to read as follows:

Sec.  152.83  Definition of exclusive use study.

    A study is an exclusive use study if it meets the conditions of
either paragraph (a) or paragraph (b) of this section.
    (a) Initial exclusive use period. A study submitted to support the
registration of a product containing a new active ingredient (new
chemical) or a new combination of active ingredients (new combination)
is an exclusive use study if all the following conditions are met:
    (1) The study pertains to a new active ingredient (new chemical) or
new combination of active ingredients (new combination) first
registered after September 30, 1978.
    (2) The study was submitted in support of, or as a condition of
approval of, the application resulting in the first registration of a
product containing such new chemical or new combination, or an
application to amend such registration to add a new use.
    (3) Less than 10 years have passed (or up to 13 years, if the
period of exclusive use protection has been extended under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) section
3(c)(1)(F)(ii)) since the issuance of the registration for which the
data were submitted.
    (4) The study was not submitted to satisfy a data requirement
imposed under FIFRA section 3(c)(2)(B).
    (b) Exclusive use period for certain minor use data. A study
submitted by an applicant or registrant to support an amendment adding
a new minor use to an existing registration that does not retain any
period of exclusive use under paragraph (b)(1) of this section is an
exclusive study under FIFRA section 3(c)(1)(F)(vi) if all the following
conditions are met:
    (1) The study relates solely to a minor use of a pesticide.
    (2) The applicant or registrant at the time the new use is
requested has notified the Administrator that any exclusive use period
for the pesticide has expired and that the study is eligible for
exclusive use treatment.
    (3) Less than 10 years have passed since the study was submitted to
EPA.
    (4) The study was not submitted to satisfy a data requirement
imposed under FIFRA section 3(c)(2)(B).
    (5) The minor use supported by the data has not been voluntarily
canceled nor have such data been used to support a non-minor use.

0
7. Revise Sec.  152.84 to read as follows:

Sec.  152.84  When materials must be submitted to the Agency.

    Information and materials required by this subpart must be
submitted at the time of application, unless the application is
determined not to be subject to the requirements of this subpart.

0
8. In Sec.  152.86, revise paragraph (b)(2)(iv) to read as follows:

Sec.  152.86  The cite-all method.

* * * * *
    (b) * * *
    (2) * * *
    (iv) The applicant's name, address, and contact information,
including telephone number and email address.
* * * * *

0
9. In Sec.  152.90, revise the last sentence of the introductory text
and paragraphs (a) and (b)(6) to read as follows:

Sec.  152.90  The selective method.

    * * * Sections 152.91 through 152.96 contain specific procedures
for citing or submitting a study or claiming a data gap.
    (a) List of data requirements. (1) Each applicant must submit a
list of the data requirements that would apply to his pesticide, its
active ingredients, and its use patterns, if the product were being
proposed for registration under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) section 3(c)(5) for the first time.
    (2) The applicant must list the applicable requirements, as
prescribed by part 158 of this chapter, as applicable. All required (R)
studies, and any studies that could be conditionally required (CR)
based upon composition, use pattern, or the results of required
studies, are to be listed. The applicant need not list data
requirements pertaining to any ingredient which qualifies for the
formulators' exemption.
    (b) * * *
    (6) Claim of data gap. Refer to Sec.  152.96.

0
10. In Sec.  152.91, revise paragraphs (a) and (c) to read as follows:

Sec.  152.91  Waiver of a data requirement.

* * * * *
    (a) Request for an extension of an existing waiver. An applicant
may claim that a waiver previously granted by the Agency also applies
to a data requirement for the product. To document this claim, the
applicant must provide a reference to the Agency record that describes
the previously granted waiver, such as an Agency list of waivers or an
applicable Reregistration Eligibility Decision (RED) document or
registration review decision document, and explain why that waiver
should apply to the product.
* * * * *
    (c) Effect of denial of waiver request. A decision by the Agency to
deny a written request for a new waiver or an extension of an existing
waiver is a final Agency action. Following denial, the applicant must
choose another method of satisfying the data requirement.

0
11. In Sec.  152.93, revise paragraph (b)(2)(v) to read as follows:

Sec.  152.93  Citation of a previously submitted valid study.

* * * * *
    (b) * * *
    (2) * * *
    (v) The applicant's name, address, and contact information,
including a telephone number and email address.
* * * * *

0
12. In Sec.  152.95, revise the introductory text and paragraph
(b)(2)(v) to read as follows:

Sec.  152.95  Citation of all studies in the Agency's files pertinent
to a specific data requirement.

    An applicant normally may demonstrate compliance for a data
requirement by citation of all studies in the Agency's files pertinent
to that data requirement. The applicant who selects

this cite-all option must submit to the Agency:
* * * * *
    (b) * * *
    (2) * * *
    (v) The applicant's name, address, and contact information,
including a telephone number and email address.
* * * * *

0
13. Revise Sec.  152.96 to read as follows:

Sec.  152.96  Claim of data gap.

    (a) When a data gap may be claimed. Except as provided in paragraph
(b) of this section, an applicant may defer his obligation to satisfy
an applicable data requirement until the Agency requires the data if no
other person has previously submitted to the Agency a valid study that
would satisfy the data requirement in question.
    (b) When a data gap may not be claimed--(1) Product containing a
new active ingredient. An applicant for registration of a product
containing a new active ingredient may not defer his obligation by
claiming a data gap unless he can demonstrate to the Agency's
satisfaction that the data requirement was imposed so recently that
insufficient time has elapsed for the study to have been completed and
that, in the public interest, the product should be registered during
the limited period of time required to complete the study. Refer to the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section
3(c)(7)(C).
    (2) Product not containing a new active ingredient. An applicant
for registration of a product under FIFRA sections 3(c)(7)(A) or (B) (a
product not containing a new active ingredient) may not defer his
obligation by claiming a data gap if the data are:
    (i) Data needed to determine whether the product is identical or
substantially similar to another currently registered product or
differs only in ways that would substantially increase the risk of
unreasonable adverse effects on the environment.
    (ii) Efficacy data specific to the product, if required to be
submitted to the Agency.
    (iii) If a new use is proposed for a product that is identical or
substantially similar to an existing product, data to demonstrate
whether the new use would substantially increase the risk of
unreasonable adverse effects on the environment.
    (c) Approval of application with a data gap claim--(1) In
accordance with Sec.  152.115(a), any registration that is approved
based upon a data gap claim shall be conditioned on the submission of
the data no later than the time that the data are required to be
submitted for similar products already registered.
    (2) Notwithstanding paragraph (c)(1) of this section, the Agency
will not approve an application if it determines that the data for
which a data gap claim has been made are needed to determine if the
product meets the requirements of FIFRA sections 3(c)(5) or (7).

0
14. Revise Sec.  152.97 to read as follows:

Sec.  152.97  Rights and obligations regarding the Data Submitters
List.

    (a) Each original data submitter shall have the right to be
included on the Agency's Data Submitters List.
    (b) Each original data submitter who wishes to have his name added
to the current Data Submitters List must submit to the Agency the
following information:
    (1) Name and current address.
    (2) Chemical name, common name (if any) and Chemical Abstracts
Service (CAS) number (if any) of the active ingredients(s), with
respect to which he is an original data submitter.
    (3) For each such active ingredient, the type(s) of study he has
previously submitted (identified by reference to data/information
requirements listed in part 158 of this chapter), the date of
submission, and the EPA registration number, file symbol, or other
identifying reference for which it was submitted.
    (c) Each applicant not already included on the Data Submitters List
for a particular active ingredient must inform the Agency at the time
of the submission of a relevant study whether he wishes to be included
on the Data Submitters List for that pesticide.

0
15. In Sec.  152.99:
0
a. Remove paragraph (a)(2)(iv).
0
b. Redesignate paragraphs (a)(2)(v) and (a)(2)(vi) as paragraphs
(a)(2)(iv) and (a)(2)(v).
0
c. Revise newly redesignated paragraph (a)(2)(iv) and paragraph (b)(2).
    The amendments read as follows:

Sec.  152.99  Petitions to cancel registration.

* * * * *
    (a) * * *
    (2) * * *
    (iv) The applicant has falsely or improperly claimed that a data
gap existed at the time of his application.
    (b) * * *
    (2) Notice to affected registrant. At the same time that the
petitioner files his petition with the Agency, the petitioner shall
send a copy to the affected applicant or registrant by certified mail
or by any other method that provides evidence of delivery. The affected
applicant or registrant shall have 60 days from the date of receipt of
the petition to submit written comments to the Agency.
* * * * *
[FR Doc. 2014-02294 Filed 2-4-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: July 30, 2009 (Volume 74, Number 145)]
[Notices]
[Page 38071-38072]
[DOCID:fr30jy09-107]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60375; File No. SR-CBOE-2009-047]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing of Proposed Rule Change, as Modified by
Amendment No. 1, Regarding the CBSX Floor Post

July 23, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on July 2, 2009, the Chicago Board Options Exchange, Incorporated
(``CBOE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the
Exchange. On July 23, 2009, the Exchange filed Amendment No. 1, which
replaced the original filing in its entirety. The Commission is
publishing this notice to solicit comments on the proposed rule change,
as amended, 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 filing proposes to modify the CBOE Stock Exchange (``CBSX'')
Rules to allow all CBSX Market-Maker types to operate from the Floor
Post. The text of the proposed rule change is available on the
Exchange's Web site (http://www.cboe.org/legal), at the Exchange's
Office of the Secretary, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    CBSX is an all electronic stock marketplace. One of the reasons
CBOE created CBSX was to try to capture some of the sizable stock
trading done by CBOE options traders. CBOE members trade stock both as
a hedging vehicle for option trades done on CBOE and in connection with
trading complex orders that contain stock and option components (e.g. a
buy-write). Thus, it was always envisioned that traders on CBOE's
trading floor would trade stock on CBSX. All CBOE members are eligible
to trade on CBSX without incurring any extra costs or completing
lengthy ``membership'' applications. CBOE also created a limited number
of CBSX Trading Permits to allow potential non-CBOE member users that
do not want to incur the significant costs associated with buying or
leasing a CBOE membership to trade on CBSX.\3\ These Permit Holders are
not allowed to trade options on CBOE.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Rel. No. 34-54987 (December 20,
2006), 71 FR 78481 (December 29, 2006) (SR-CBOE-2006-107).
---------------------------------------------------------------------------

    To help generate interest in CBSX with the CBOE trading floor
community, the Exchange established the CBSX Floor Post. The Floor Post
is a location on the CBOE trading floor where CBSX Designated Primary
Market-Maker (``DPM'') personnel can be stationed to respond to stock
price discovery requests from CBOE's trading floor community. As part
of CBSX's approval, the Exchange was asked to physically separate the
CBSX Floor Post from the options trading posts (i.e. eliminate
sightlines between the Floor Post and

any equity option trading posts). This request was made to avoid any
potential issues related to ``side-by-side trading'' which involves a
stock trading location situated in close and open physical proximity to
a location where a derivative on that stock (e.g., an option) is
traded.\4\ The Rule governing the CBSX Floor Post is Rule 51.12.
---------------------------------------------------------------------------

    \4\ Side-by-side trading concerns originated in connection with
open outcry trading on exchange trading floors (i.e., they pre-date
the advent of all-electronic exchanges).
---------------------------------------------------------------------------

    The Exchange now proposes to modify Rule 51.12 to permit all CBSX
Market-Makers types to utilize the Floor Post. Currently, the Rule
provides that only CBSX DPMs may operate from the Floor Post (brokers
are also permitted to enter the Floor Post area).\5\ Recently, however,
CBSX has received requests from CBSX Market-Makers seeking to operate
from the Floor Post. This filing would allow them to do so. The Floor
Post continues to restrict any sightlines to the equity option trading
posts. Also, the CBSX Fees Schedule has been amended to include a fee
for CBSX Market-Makers using the CBSX Floor Post.
---------------------------------------------------------------------------

    \5\ No CBSX DPMs are situating personnel at the Floor Post at
this time. It is empty.
---------------------------------------------------------------------------

    The Exchange has also received inquiries from CBSX Trading Permit
Holders that act in the capacity of CBSX Brokers to operate from CBOE's
trading floor. Many current CBOE members (including Floor Brokers)
execute stock orders on CBSX from the trading floor. Trading Permit
Holders on the CBOE trading floor would enter orders on CBSX just like
any other user on the CBOE trading floor. The only difference is that
CBSX Trading Permit holders are not allowed to trade options (and have
not incurred the costs associated with CBOE membership). The Exchange
has established a fee for Trading Permit Holders that operate on CBOE's
trading floor from a perimeter booth (these booths, which are typically
occupied by CBOE Floor Brokers, are located around the perimeter of the
trading floor).\6\
---------------------------------------------------------------------------

    \6\ See SR-CBOE-2009-044.
---------------------------------------------------------------------------

    It is possible that no CBSX Trading Permit Holders (whether they
are CBSX Market-Maker or CBSX Brokers) ultimately decide to establish a
physical operation on the CBOE trading floor. However, to the extent
that they do, any CBSX Market-Making would be limited to operating from
the CBSX Floor Post, while CBSX Brokers would be allowed to establish
operations at perimeter booths.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') \7\ and the rules and
regulations thereunder and, in particular, the requirements of Section
6(b) of the Act.\8\ Specifically, the Exchange believes the proposed
rule change is consistent with the Section 6(b)(5) \9\ requirements
that the rules of an exchange be designed to promote just and equitable
principles of trade, to prevent fraudulent and manipulative acts, to
remove impediments to and to perfect the mechanism for a free and open
market and a national market system, and, in general, to protect
investors and the public interest. Permitting CBSX Market Makers to use
the CBSX Floor Post along with Floor Brokers and CBSX DPM personnel
promotes just and equitable principles of trade and removes impediments
to and perfects the mechanism for a free and open market.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(1).
    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    CBOE 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.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding, or (ii) as to
which NYSE consents, the Commission will:
    (A) By order approve such proposed rule change; or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2009-047 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2009-047. This file
number should be included on the subject line if e-mail 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 Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying 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 such filing also will be available for
inspection and copying at the principal offices of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-CBOE-2009-047 and should be
submitted on or before August 20, 2009.
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-18166 Filed 7-29-09; 8:45 am]

BILLING CODE 8010-01-P


Re: EPA Human Studies Review Board meeting, Tuesday May 2, 2006.

Science and Ethics of Chromium Human Studies.

I understand that my task for the board is primarily to be a consultant on the scientific part of it as no other specialists in contact dermatitis and patch testing is present. I have read through the ethical evaluation and understand the comments. I see my task as primarily discussing whether the Nethercott study is scientifically sound in the estimation of safe level of dermal exposure to hexavalent chromium.

Re: J Nethercott.

A study of chromium induced allergic contact dermatitis with 54 volunteers: implications for environmental risk assessment.

Occupational and Environmental Medicine 1994: 51: 371 380.

The paper gives a broad introduction to the phenomenon contact allergy and contact allergy to chromium. The study is critical to former studies, first of all because of reading of patch tests and application of multiple patch tests. The intention by the study is to use the diagnostic patch test in a dose response manner to establish a non elicitation level of chromate allergy. This study limits itself to pre sensitized individuals. That's to say any kind of primary sensitization is not attempted and not evaluated. It only concerns people who have been diagnosed contact allergic to chromium by a dermatologist. That's to say that they probably have had the skin condition allergic contact dermatitis, which in the first place has led them to the dermatologist. In that way the group are selected and cannot be expected to represent the general population, but only the population of chromate sensitive with clinical symptoms. This selection process is clearly described and easy to understand. For the diagnosis of chromium allergy they used a patch test system. They used the newly developed patch test system the True Test. This is having several advantages as it is prefabricated and has a defined content of chromium/ cm2. For the reading of a positive patch test there are fixed rules described based on the morphology of the test outcome in the paper. The testing of the individuals is done in a 3 step fashion which ensures that no patients have more positive patch tests than necessary and the risk of interference among the positive tests is minimalized. The planning and conduction of the patch test is according to high scientific level within the speciality and only relatively few patch test dose response studies will make this 3 step procedure. Most actually use 1 step procedure. The selection of the patch test concentrations is well argumented. Many studies will have more steps in the dilution series. It will probably not have added further to the scientific information.

The study describes in a clear way the establishment of a minimum elicitation level and designs a dose response curve analysed according to computer model data technique. The methodology is advanced in relation to the time when the study was carried out and is still in accordance with the methodologies employed today.

The second part of the study, where the authors are comparing the influence of total dose versus dose per unit area has more the character of a pilot study.

The final calculations of the acceptable exposure concentration for chrome 6 and 3 is in my view difficult to follow.

Conclusion: The conduction and the method used for the Nethercott study are in accordance with the best standard within the research area of human studies within contact dermatitis. It is important that the methodology used is a close patch test system. This is primarily developed as a diagnostic tool. Within this respect it is used to define the non elicitation level. This is undoubtedly scientifically correct. It could be argued that the study could have been supplemented with studies simulating the intended exposure question. This could e. g. handling of chromium preserved wood under standardized circumstances or exposure for different time periods to the skin with chromium preserved wood. Such studies could have excluded some of the uncertainty factors involved in the calculation of the minimum elicitation concentration related to real life situation. In the evaluation of the patch test the international accepted score for a positive diagnostic test is used. This is of course scientifically correct but also gives a conservative estimate. It should be remembered that from the start it is known that all patients are chromium allergic and the very low concentrations are actually non irritating. In recent European studies a special reading scale is used concerning dose response studies, where also weaker responses as e. g. follicular responses are judged as positives.


[Federal Register Volume 85, Number 54 (Thursday, March 19, 2020)]
[Notices]
[Pages 15844-15847]
[FR Doc No: 2020-05670]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 33816; 812-15043]

Daxor Corporation; Notice of Application

March 13, 2020.

AGENCY:  Securities and Exchange Commission (``Commission'').

ACTION:  Notice of an application for an order under section 6(c) of
the Investment Company Act of 1940 (the ``Act'') for an exemption from
sections 18(d) and 23(a) and (b) of the Act, pursuant to section
23(c)(3) of the Act granting an exemption from section 23(c) of the
Act, and pursuant to rule 17d-1 under the Act to permit certain joint
transactions otherwise prohibited under section 17(d) of the Act.

Applicant:  Daxor Corporation (``Daxor'').

Summary of Application:  Applicant requests an order to permit, subject
to shareholder approval, the Applicant to adopt an incentive
compensation plan.

Filing Dates:  The application was filed on June 24, 2019, and amended
on October 17, 2019, and January 21, 2020.

Hearing or Notification of Hearing:  An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving Applicant with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on April 7, 2020 and should be accompanied by proof of
service on Applicant, in the form of an affidavit or, for lawyers, a
certificate of service. Pursuant to rule 0-5 under the Act, hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, the reason
for the request, and the issues contested. Persons who wish to be
notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES:  Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE, Washington, DC 20549-1090. Applicant: Robert J. Michel,
Chief Financial Officer, Daxor Corporation, 350 Fifth Avenue, Suite
4740, New York, NY 10118.

FOR FURTHER INFORMATION CONTACT:  Kyle R. Ahlgren, Senior Counsel, at
(202) 551-6857, or David P. Nicolardi, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION:  The following is a summary of the
application. The complete application may be obtained via the
Commission's website by searching for the file number or an Applicant
using the ``Company'' name box, at http://www.sec.gov/search/search.htm
or by calling<PHONE_NUMBER>.

Applicant's Representations

    1. Applicant, a New York corporation, is an investment company with
medical instrumentation and biotechnology operations. Applicant is
registered under the Act as an internally-managed, closed-end
management investment company.
    2. Applicant has six directors, four of whom are not ``interested
persons'' of the company as defined in section 2(a)(19) of the Act
(``Non-Interested Directors''), and fifteen employees.
    3. Applicant has in the past issued stock options (``Options'')
under the Daxor Corporation 2004 Stock Option Plan (``2004 Daxor
Plan),\1\ although Applicant no longer does so.
---------------------------------------------------------------------------

    \1\ Applicant is not requesting any relief regarding the
operation of the 2004 Daxor Plan.
---------------------------------------------------------------------------

    4. Applicant states that, because the medical instrumentation and
biotechnology business is highly competitive, it believes that its
successful operation will depend on its ability to attract, motivate
and retain its employees with competitive compensation packages similar
to those offered by its competitors. Applicant asserts that the
companies with whom the Applicant competes for management talent are
not registered investment

companies subject to the Act and are thus able to offer their
directors, officers and other personnel various types of non-cash,
deferred compensation, including opportunities for equity participation
in the enterprise, as well as cash incentive and performance based
compensation. Accordingly, Applicant is requesting relief to permit,
subject to final approval by the Board of Directors (``Board'') and
approval of the Applicant's shareholders, the adoption of the Daxor
2020 Incentive Compensation Plan (``2020 Daxor Plan'' or ``Plan'').
    5. The 2020 Daxor Plan is administered by a committee of the Board
composed solely of independent directors (the ``Committee''). The
Committee is composed solely of three or more directors who (i) are
Non-Interested Directors of the Applicant, and (ii) are non-employee
directors within the meaning of rule 16b-3 under the Securities
Exchange Act of 1934, as amended (the ``Exchange Act'') (``Non-Employee
Directors''). The 2020 Daxor Plan, if approved by shareholders, would
permit Applicant to issue options,\2\ stock appreciation rights
(including freestanding and tandem stock appreciation rights),
restricted shares of stock, restricted stock units, deferred stock
units (``Deferred Stock Units''),\3\ shares of common stock granted as
a bonus (``Bonus Stock''),\4\ and awards denominated in cash (``Cash
Awards'') \5\ (collectively, ``Awards'') to Eligible Persons,\6\
subject to the terms and conditions discussed below. In addition, the
2020 Daxor Plan would permit dividend equivalents to be awarded in
connection with any Awards under the 2020 Daxor Plan while the Awards
are outstanding or otherwise subject to a restriction period on a like
number of shares of Applicant's common stock. Furthermore, certain
Awards may be subject to performance conditions as may be specified by
the Committee.\7\
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    \2\ The exercise price of options must not be not less than the
fair market value (``Fair Market Value'') of a share of the
Applicant's stock on the date of the grant, except as such price is
adjusted to reflect certain corporate actions. For purposes of the
Plan, Fair Market Value means a price that is based on the opening,
closing, actual, high or low sale price, or the arithmetic mean of
selling prices of, a share of common stock, on the NYSE American LLC
(or such other national securities exchange or automated inter-
dealer quotation system on which the common stock is principally
trading) on the applicable date, the preceding trading day, the next
succeeding trading day, or the arithmetic mean of selling prices on
all trading days over a specified averaging period weighted by
volume of trading on each trading day in the period that is within
30 days before or 30 days after the applicable date, as determined
by the Committee in its discretion; provided that, if an arithmetic
mean of prices is used to set a grant price or an exercise price for
an option or stock appreciation right, the commitment to grant the
applicable Award based on such arithmetic mean must be irrevocable
before the beginning of the specified averaging period in accordance
with Treasury Regulation Sec.  1.409A-1(b)(5)(iv)(A).
    \3\ A Deferred Stock Unit is a right to receive stock, cash or a
combination thereof at the end of a deferral period specified by the
Committee (or if permitted by the Committee, as elected by the
Eligible Person).
    \4\ Except as otherwise determined by the Committee, Bonus Stock
will vest immediately and shall not be subject to any restrictions.
    \5\ Cash Awards may be satisfied in cash, by delivery of the
number of shares valued at the Fair Market Value on the payout date,
or a combination thereof, as determined by the Committee at the date
of grant or thereafter.
    \6\ Under the 2020 Daxor Plan, awards may be granted to (i) any
person, including officers and directors, in the regular employment
of the company and (ii) any Non-Employee Director of the company
(``Eligible Persons'').
    \7\ ``Performance Award'' means an Award granted to an Eligible
Person which is conditioned upon satisfaction, during a period of at
least one year but in no event more than ten years, of performance
criteria established by the Committee.
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    6. Applicant represents that the 2020 Daxor Plan has been approved
by the Board of Directors, including a majority of the Non-Interested
Directors of the Applicant. Subject to receipt of the Order, the Board
is expected to approve the submission of the 2020 Daxor Plan, in its
final form, to stockholders for approval at a shareholder meeting. The
2020 Daxor Plan, in its final form, will become effective upon approval
by stockholders. Applicant represents that it will submit the 2020
Daxor Plan to stockholders for approval once every five years.\8\
Applicant further represents that the Board of Directors, or at its
direction, the Committee, will also approve policies and procedures,
established by the Applicant, reasonably designed to comply with the
conditions to the requested order set forth below.
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    \8\ In addition, any amendment to the 2020 Daxor Plan will be
subject to the approval of the Applicant's stockholders to the
extent such approval is required by applicable laws or regulations,
including exchange rules, or as the Board otherwise determines. The
Applicant's Board is required to review the 2020 Daxor Plan at least
annually.
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    7. Immediately following each annual meeting of stockholders, each
Non-Employee Director who is elected a director at, or who was
previously elected and continues as a director after, that annual
meeting may receive, at the discretion of the Committee, an award of up
to 500 shares of vested Bonus Stock without restrictions. In addition,
the 2020 Daxor Plan permits, to the extent provided for in the
applicable Award agreement, recipients of Awards to receive dividend
equivalents in respect of such Awards or any portion thereof as
specified in the applicable Award agreement equal to the amount or
value of any cash or other dividends or distributions payable on an
equivalent number of shares of common stock. Any such dividend
equivalents will be paid in shares of common stock, cash or a
combination thereof as and when provided for in the applicable Award
agreement.
    8. The total number of shares of common stock reserved and
available for delivery in connection with Awards under the 2020 Daxor
Plan (other than any shares of common stock issued in payment of
dividend equivalents) may not exceed 250,000 or 5% of Applicant's
outstanding shares, whichever is the larger number. As of January 1,
2020, 250,000 shares represents 6.7% of Applicant's current outstanding
shares.
    9. Applicant states that, in the event that any extraordinary
dividend, capital gains distribution or other distribution (whether in
the form of cash, common stock or other property), recapitalization,
forward or reverse stock split, reorganization, merger, consolidation,
spin-off, combination, repurchase, share exchange, liquidation,
dissolution or other similar corporate transaction or event affects the
common stock such that an adjustment is determined by the Committee to
be appropriate under the 2020 Daxor Plan, then the Committee shall, in
such manner as it may deem equitable, adjust any or all of (i) the
aggregate number of shares of common stock subject to the 2020 Daxor
Plan; (ii) the number and kind of shares of common stock which may be
delivered in connection with Awards granted thereafter; (iii) the
number and kind of shares of common stock subject to or deliverable in
respect of outstanding Awards; (iv) the exercise price or grant price
relating to any Award and/or make provision for payment of cash or
other property in respect of any outstanding Award; and (v) the
performance conditions with respect to any outstanding Award.

Applicant's Legal Analysis:

Sections 18(d), 23(a) and 23(b) of the Act

    1. Section 18(d) of the Act prohibits any registered management
investment company from issuing warrants or rights to subscribe to or
purchase its securities, except those issued exclusively and ratably to
a class of the company's security holders with an exercise period of up
to 120 days or in exchange for warrants in connection with a
reorganization. Applicant states that section 18(d) would prohibit the
issuance of certain Awards to Eligible Persons because no corresponding
warrants or rights would be issued to

the Applicant's stockholders and because the Awards would not be issued
in connection with a reorganization.
    2. Section 23(a) of the Act generally prohibits a registered
closed-end investment company from issuing its securities for services.
Applicant states that because Awards are a form of compensation, the
issuance of stock-based Awards to Eligible Persons would constitute the
issuance of securities for ``services'' and, therefore, absent an
exemption, would fall within the prohibitions of section 23(a).
    3. Section 23(b) of the Act prohibits a registered closed-end
investment company from selling its common stock at a price below its
current NAV. Applicant states that Options will be issued with an
exercise price that is not less than the Fair Market Value, and other
Awards based on common stock of the Applicant are generally valued at
Fair Market Value. Applicant further states that on the date of grant
and date of exercise, an Option's or Stock Appreciation Right's
exercise price may be less than the net asset value of a share of the
Applicant's stock on such dates.
    4. Section 6(c) of the Act provides, in part, that the Commission
may, by order upon application, conditionally or unconditionally exempt
any person, security or transaction, or any class or classes thereof,
from any provision of the Act, if and to the extent that the exemption
is necessary or appropriate in the public interest and consistent with
the protection of investors and the purposes fairly intended by the
policy and provisions of the Act. Applicant requests an exemption under
section 6(c) from section 18(d) and sections 23(a) and (b) of the Act
to the extent necessary to implement the Plan.
    5. Applicant states that the concerns underlying those sections
include (i) the possibility that Options could be granted to persons
whose interests might be contrary to the interests of stockholders;
(ii) the potential dilutive impact of Options on stockholders; (iii)
the possibility that Options might facilitate a change of control; (iv)
the introduction of complexity and uncertainty into the investment
company's financial structure, thereby making it more difficult to
appraise the value of their stock; (v) possible obfuscation of the
extent of management compensation; and (vi) encouragement of
speculative portfolio investments at the insistence of the option
holders (to increase the possibility of a rise in market price from
which they might benefit). Applicant asserts that these concerns would
not apply to the Awards for the reasons discussed below and in the
application.
    6. Applicant states that, because Awards under the Plan may be
issued only to Eligible Persons, Awards will not be granted to
individuals with interests contrary to those of the applicant's
stockholders. Moreover, no Eligible Person may, in general, be granted
Awards that in the aggregate exceed 35% of the shares of common stock
reserved for issuance under the Plan. In addition, in no event may the
total number of shares of stock, with respect to which all types of
Awards may be granted to an Eligible Person under the Plan exceed
75,000 shares of stock within any thirty-six month period during which
the Plan is in effect.
    7. Applicant represents that the 2020 Daxor Plan will be submitted
to stockholders for their approval in compliance with Item 10 of
Schedule 14A under the Exchange Act, with the standards and guidelines
adopted by the Financial Accounting Standards Board, and the
requirements of Item 402 of Regulation S-K, Item 8 of Schedule 14A
under the Exchange Act, and Item 18 of Form N-2. In addition, Applicant
will comply with the disclosure requirements for executive compensation
plans applicable to operating companies under the Exchange Act.
Applicant asserts that the Plan will be adequately disclosed to
investors and appropriately reflected in the market value of their
stock.
    8. Applicant acknowledges that Awards granted under the Plan would
have a dilutive effect on the stockholders' equity in Applicant, but
argue that the effect would not be significant and would be outweighed
by the anticipated benefits of the Plan to Applicant and its
stockholders.\9\ Applicant believes that the flexibility to offer
equity-based employee compensation is essential to its ability to
compete. Applicant also asserts that equity-based compensation would
more closely align the interests of Applicant and its employees and
directors with those of Applicant's stockholders.
---------------------------------------------------------------------------

    \9\ Applicant represents that the maximum potential dilution to
an applicant's stockholders (in terms of net asset value per share)
that would result from grants of Awards under the Plan would be
approximately 6.7%. Applicant submits that the conditions in the
requested order would provide protection to investors against
dilution of their pro rata interests that are similar to those the
Commission has previously found consistent with the purposes and
policies of the Act and are even greater than those that Congress
imposed on stock options issued by business development companies
(``BDCs''). Applicant states that less dilution could occur under
the Plan than from stock options issued by BDCs, on which Congress
imposed a 25% limit on the maximum increase in the amount of voting
securities that could result if all outstanding warrants, options
and other rights were exercised.
---------------------------------------------------------------------------

    9. Applicant states that stockholders will be further protected by
the conditions to the requested order that assure continuing oversight
of the operation of the 2020 Daxor Plan by the Board. Applicant asserts
that the requested exemptions are consistent with the protection of
investors because of the proposed limitations on the grant of Awards
and the required Board and shareholder approvals. Finally, Applicant
argues that the 2020 Daxor Plan is consistent with the policies and
purposes of the Act because the Commission and Congress have previously
permitted certain companies regulated under the Act to issue stock
options and to adopt incentive compensation plans similar to the 2020
Daxor Plan.

Section 17(d) of the Act

    10. Section 17(d) of the Act and rule 17d-1 under the Act generally
prohibit an affiliated person of a registered investment company, or an
affiliated person of such a person, from participating in a joint
enterprise, joint arrangement or profit-sharing plan in which the
company is a participant, unless the Commission by order approves the
transaction. Rule 17d-l(c) defines a joint enterprise to include any
stock option or stock purchase plan. Rule 17d-1(b) provides that, in
considering relief pursuant to the rule, the Commission will consider
(i) whether the participation of the registered investment company in a
joint enterprise is consistent with the Act's policies and purposes and
(ii) the extent to which that participation is on a basis different
from or less advantageous than that of other participants. Section
2(a)(3) of the Act defines an ``affiliated person'' of another person
to include any officer, director, partner, copartner or employee of
such other person. Because all Eligible Persons are either directors or
employees of Applicant, Eligible Persons fall within the scope of
section 17(d) and rule 17d-1 and, consequently, are prohibited from
participating in the Plan, absent the requested relief.
    11. Applicant requests an order pursuant to section 17(d) and rule
17d-1 to permit the operation of the Plan. Applicant states that the
Plan, although benefiting Eligible Persons and Applicant in different
ways, are in the interests of stockholders of the Applicant because the
Plan would help them attract, motivate and retain talented
professionals and help align the interests of employees with those of
their stockholders. Thus, Applicant

asserts that its participation in the Plan will be on a basis no less
advantageous than that of Eligible Persons.\10\
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    \10\ As noted above, Applicant also asserts that the Plan is
consistent with the policies and purposes of the Act because the
Commission and Congress have previously permitted certain companies
regulated under the Act to issue stock options and to adopt
incentive compensation plans similar to the Plan.
---------------------------------------------------------------------------

Section 23(c) of the Act

    12. Section 23(c) of the Act generally prohibits a registered
closed-end investment company from purchasing any securities of which
it is the issuer except in the open market, pursuant to tender offers
or under other circumstances as the Commission may permit to insure
that the purchase is made on a basis that does not unfairly
discriminate against any holders of the class or classes of securities
to be purchased.
    13. Applicant states that the payment of a stock option exercise
price with previously acquired stock of the Applicant or with shares
withheld by the Applicant may be deemed a purchase by the Applicant of
its own securities within the prohibition of section 23(c).\11\
Applicant therefore requests an order under section 23(c) to permit
these purchases. Applicant states that it will purchase its shares from
Eligible Persons at their Fair Market Value on the relevant date, which
would not be significantly different from the price at which all other
stockholders could sell their shares in a market transaction. Applicant
therefore submits that such transactions would not unfairly
discriminate against other stockholders.
---------------------------------------------------------------------------

    \11\ Applicant states this analysis could also apply in the case
of shares withheld by Applicant or delivery of shares by an Eligible
Person in satisfaction of withholding taxes.
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Applicant's Conditions

    Applicant agrees that any order of the Commission granting the
requested relief will be subject to the following conditions:
    1. The Board will maintain a Committee, none of the members of
which will be ``interested persons'' of the Applicant as defined in the
Act. The Committee will administer the 2020 Daxor Plan and will be
composed of three or more directors of the Applicant who (i) are Non-
Interested Directors of the Applicant, and (ii) are Non-Employee
Directors within the meaning of rule 16b-3 under the Exchange Act.
    2. The Plan will not be operated unless it is approved by a
majority of the votes cast by stockholders at a meeting called to
consider the Plan. Any amendment to the 2020 Daxor Plan will be subject
to the approval of Applicant's stockholders to the extent such approval
is required by applicable law or regulation or the Board otherwise
determines. Unless terminated or amended, during the fifth year of the
2020 Daxor Plan (and each fifth year thereafter), the Plan shall be
submitted for reapproval to the Applicant's stockholders and all Awards
made during that year shall be contingent upon stockholder approval.
    3. Awards are not transferable or assignable, except as the
Committee will specifically approve to facilitate estate planning or to
a beneficiary upon an Eligible Person's death or by will or the laws of
descent and distribution. Awards may also be transferred pursuant to a
qualified domestic relations order.
    4. The maximum number of shares of stock available for delivery in
connection with all Awards granted under the 2020 Daxor Plan may not
exceed 250,000 of such shares, or 5% of the Applicant's outstanding
shares, whichever is the larger number, subject to adjustment for
corporate transactions.
    5. The Board will review the 2020 Daxor Plan at least annually. In
addition, the Committee periodically will review the potential impact
that the grant, exercise, or vesting of Awards could have on the
Applicant's earnings and net asset value per share, such review to take
place prior to any decisions to grant Awards, but in no event less
frequently than annually. Adequate procedures and records will be
maintained to permit such review, and the Committee will be authorized
to take appropriate steps to ensure that neither the grant nor the
exercise or vesting of Awards would have an effect contrary to the
interests of investors in the Applicant. This will include the
authority to prevent or limit the grant of additional Awards. All
records maintained pursuant to this condition will be subject to
examination by the Commission and its staff.
    6. Awards under the 2020 Daxor Plan are issuable only to Eligible
Persons. No person will be granted Awards denominated by reference to
shares, or be issued shares in settlement of Awards not initially
denominated by reference to shares, that in the aggregate exceed 35% of
the shares initially reserved for issuance under the Plan, subject to
adjustment under the Plan. Subject to the immediately preceding
limitation, in any thirty-six month period during which the Plan is in
effect, no person may be granted Awards under the Plan relating to more
than 75,000 shares, which amount may be adjusted to reflect certain
corporate transactions or events that affect the Applicant's stock.
Grants to Non-Employee Directors are limited to those described in
condition 7 below.
    7. In each fiscal year, a Non-Employee Director may be granted up
to 500 shares of vested Bonus Stock without restrictions, which amount
may be adjusted to reflect certain corporate transactions.

    For the Commission, by the Division of Investment Management,
under delegated authority.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-05670 Filed 3-18-20; 8:45 am]
 BILLING CODE 8011-01-P