[Federal Register: January 26, 2010 (Volume 75, Number 16)]
[Notices]
[Page 4081-4086]
[DOCID:fr26ja10-63]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0019]

Agency Information Collection Activities; Proposed Collection;
Comment Request; General Licensing Provisions: Biologics License
Application, Changes to an Approved Application, Labeling, Revocation
and Suspension, Postmarketing Studies Status Reports, and Forms FDA
356h and 2567

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for

public comment in response to the notice. This notice solicits comments
on the collection of information relating to general licensing
provisions for biologics license applications (BLAs), changes to an
approved application, labeling, revocation and suspension,
postmarketing studies status reports, and Forms FDA 356h and 2567.

DATES: Submit written or electronic comments on the collection of
information by March 29, 2010.

ADDRESSES:  Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

General Licensing Provisions: Biologics License Application, Changes to
an Approved Application, Labeling, Revocation and Suspension,
Postmarketing Studies Status Reports, and Forms FDA 356h and 2567 (OMB
Control Number 0910-0338)--Extension

    Under section 351 of the Public Health Service Act (the PHS Act)
(42 U.S.C. 262), manufacturers of biological products must submit a
license application for FDA review and approval before marketing a
biological product in interstate commerce. Licenses may be issued only
upon showing that the establishment and the products for which a
license is desired meets standards prescribed in regulations designed
to ensure the continued safety, purity, and potency of such products.
All such licenses are issued, suspended, and revoked as prescribed by
regulations in part 601 (21 CFR part 601).
    Section 130(a) of the Food and Drug Administration Modernization
Act (Public Law 105-115) amended the Federal Food, Drug, and Cosmetic
Act (the act) by adding a new provision (section 506B of the act (21
U.S.C. 356b)) requiring reports of postmarketing studies for approved
human drugs and licensed biological products. Section 506B of the act
provides FDA with additional authority to monitor the progress of
postmarketing studies that applicants have made a commitment to conduct
and requires the agency to make publicly available information that
pertains to the status of these studies. Under section 506B(a) of the
act, applicants that have committed to conduct a postmarketing study
for an approved human drug or licensed biological product must submit
to FDA a status report of the progress of the study or the reasons for
the failure of the applicant to conduct the study. This report must be
submitted within 1 year after the U.S. approval of the application and
then annually until the study is completed or terminated.
    A summary of additional collection of information requirements
follows:
    Section 601.2(a) requires a manufacturer of a biological product to
submit an application on forms prescribed for such purposes with
accompanying data and information, including certain labeling
information, to FDA for approval to market a product in interstate
commerce. The container and package labeling requirements are provided
under Sec. Sec.  610.60 through 610.65 (21 CFR 610.60 through 610.65).
The estimate for these regulations is included in the estimate under
Sec.  601.2(a) in table 1 of this document.
    Section 601.5(a) requires a manufacturer to submit to FDA notice of
its intention to discontinue manufacture of a product or all products.
Section 601.6(a) requires the manufacturer to notify selling agents and
distributors upon suspension of its license, and provide FDA of such
notification.
    Section 601.12(a)(2) requires, generally, that the holder of an
approved BLA must assess the effects of a manufacturing change before
distributing a biological product made with the change. Section
601.12(a)(4) requires, generally, that the applicant must promptly
revise all promotional labeling and advertising to make it consistent
with any labeling changes implemented. Section 601.12(a)(5) requires
the applicant to include a list of all changes contained in the
supplement or annual report; for supplements, this list must be
provided in the cover letter. The burden estimates for Sec.
601.12(a)(2) are included in the estimates for supplements (Sec.
601.12(b) and (c)) and annual reports (Sec.  601.12(d)). The burden
estimates for Sec.  601.12(a)(4) are included in the estimates under
Sec.  601.12(f)(4) in table 1 of this document.
    Section 601.12(b)(1), (b)(3), (c)(1), (c)(3), (c)(5), (d)(1), and
(d)(3) requires applicants to follow specific procedures to submit
information to FDA of any changes, in the product, production process,
quality controls, equipment, facilities, or responsible personnel
established in an approved license application. The appropriate
procedure depends on the potential for the change to have a
substantial, moderate, or minimal adverse effect on the identity,
strength, quality, purity, or potency of the products as they may
relate to the safety or effectiveness of the product. Under Sec.
601.12(b)(4), an applicant may ask FDA to expedite its review of a
supplement for public health reasons or if a delay in making the change
described in it would impose an extraordinary hardship of the
applicant. The burden estimate for Sec.  601.12(b)(4) is minimal and
included in the estimate under Sec.  601.12(b)(1) and (b)(3) in table 1
of this document.
    Section 601.12(e) requires applicants to submit a protocol, or
change to a protocol, as a supplement requiring FDA approval before
distributing the product. Section 601.12(f)(1), (f)(2), and (f)(3)
requires applicants to follow specific procedures to report certain

labeling changes to FDA. Section 601.12(f)(4) requires applicants to
report to FDA advertising and promotional labeling and any changes.
    Under Sec.  601.14, the content of labeling required in 21 CFR
201.100(d)(3) must be in electronic format and in a form that FDA can
process, review, and archive. This requirement is in addition to the
provisions of Sec. Sec.  601.2(a) and 601.12(f). The burden estimate
for Sec.  601.14 is minimal and included in the estimate under
Sec. Sec.  601.2(a) (BLAs) and 601.12(f)(1), (f)(2), and (f)(3)
(labeling supplements and annual reports) in table 1 of this document.
    Section 601.45 requires applicants of biological products for
serious or life-threatening illnesses to submit to the agency for
consideration, during the pre-approval review period, copies of all
promotional materials, including promotional labeling as well as
advertisements.
    In addition to Sec. Sec.  601.2 and 601.12, there are other
regulations in parts 640, 660, and 680 (21 CFR parts 640, 660, and 680)
that relate to information to be submitted in a license application or
supplement for certain blood or allergenic products as follows:
Sec. Sec.  640.6, 640.17, 640.21(c), 640.22(c), 640.25(c), 640.56(c),
640.64(c), 640.74(a) and (b)(2), 660.51(a)(4), and 680.1(b)(2)(iii) and
(d). In table 1 of this document, the burden associated with the
information collection requirements in these regulations is included in
the burden estimate for Sec. Sec.  601.2 and/or 601.12. A regulation
may be listed under more than one paragraph of Sec.  601.12 due to the
type of category under which a change to an approved application may be
submitted.
    There are also additional container and/or package labeling
requirements for certain licensed biological products including: Sec.
640.70(a) for Source Plasma; Sec.  640.74(b)(3) and (4) for Source
Plasma Liquid; Sec.  640.84(a) and (c) for Albumin; Sec.  640.94(a) for
Plasma Protein Fraction; Sec.  660.2(c) for Antibody to Hepatitis B
Surface Antigen; Sec.  660.28(a), (b), and (c) for Blood Grouping
Reagent; Sec.  660.35(a), (c) through (g), and (i) through (m) for
Reagent Red Blood Cells; Sec.  660.45 for Hepatitis B Surface Antigen;
and Sec.  660.55(a) and (b) for Anti-Human Globulin. The burden
associated with the additional labeling requirements for submission of
a license application for these certain biological products is minimal
because the majority of the burden is associated with the requirements
under Sec. Sec.  610.60 through 610.65 or Sec.  809.10 (21 CFR 809.10).
Therefore, the burden estimates for these regulations are included in
the estimate under Sec. Sec.  610.60 through 610.65 in table 1 of this
document. The burden estimates associated with Sec.  809.10 are
approved under OMB Control No. 0910-0485.
    Section 601.25(b) requests interested persons to submit, for review
and evaluation by an advisory review panel, published and unpublished
data and information pertinent to a designated category of biological
products that have been licensed prior to July 1, 1972. Section
601.26(f) requires that licensees submit to FDA a written statement
intended to show that studies adequate and appropriate to resolve the
questions raised about a biological product have been undertaken for a
product if designated as requiring further study under the
reclassification procedures. Under Sec.  601.25(b), FDA estimates no
PRA burden for this regulation, and therefore this regulation is not
included in table 1 of this document. Under section 601.26(f), FDA
estimates no burden for this regulation since there are no products
designated to require further study and none are predicted in the
future. However, FDA is using an estimate of one for calculation
purposes. Based on the possible reclassification of a product, the
labeling for the product may need to be revised, or a manufacturer, on
its own initiative, may deem it necessary for further study. As a
result, any changes to product labeling would be reported under the
appropriate paragraph of Sec.  601.12.
    Section 601.27(a) requires that applications for new biological
products contain data that are adequate to assess the safety and
effectiveness of the biological product for the claimed indications in
pediatric subpopulations, and to support dosing and administration
information. Section 601.27(b) provides that an applicant may request a
deferred submission of some or all assessments of safety and
effectiveness required under Sec. 601.27(a) until after licensing the
product for use in adults. Section 601.27(c) provides that an applicant
may request a full or partial waiver of the requirements under Sec.
601.27(a) with adequate justification. The burden estimates for Sec.
601.27(a) are included in the burden estimate under Sec.  601.2(a) in
table 1 of this document since these regulations deal with information
to be provided in an application.
    Section 601.28 requires sponsors of licensed biological products to
submit the information in Sec.  601.28(a), (b), and (c) to the Center
for Biologics Evaluation and Research (CBER) or the Center for Drug
Evaluation and Research (CDER) each year, within 60 days of the
anniversary date of approval of the license. Section 601.28(a) requires
sponsors to submit to FDA a brief summary stating whether labeling
supplements for pediatric use have been submitted and whether new
studies in the pediatric population to support appropriate labeling for
the pediatric population have been initiated. Section 601.28(b)
requires sponsors to submit to FDA an analysis of available safety and
efficacy data in the pediatric population and changes proposed in the
labeling based on this information. Section 601.28(c) requires sponsors
to submit to FDA a statement on the current status of any postmarketing
studies in the pediatric population performed by, on or behalf of, the
applicant. If the postmarketing studies were required or agreed to, the
status of these studies is to be reported under Sec.  601.70 rather
then under this section.
    Sections 601.33 through 601.35 clarify the information to be
submitted in an application to FDA to evaluate the safety and
effectiveness of in vivo radiopharmaceuticals. The burden estimates for
Sec. Sec.  601.33 through 601.35 are included in the burden estimate
under Sec.  601.2(a) in table 1 of this document since these
regulations deal with information to be provided in an application.
    Section 601.70(b) requires each applicant of a licensed biological
product to submit annually a report to FDA on the status of
postmarketing studies for each approved product application. Each
annual postmarketing status report must be accompanied by a completed
transmittal Form FDA 2252 (Form FDA 2252 approved under OMB Control No.
0910-0001). Under Sec.  601.70(d), two copies of the annual report
shall be submitted to FDA.
    Sections 601.91 through 601.94 concerns biological products for
which human efficacy studies are not ethical or feasible. Section
601.91(b)(3) requires applicants to prepare and provide labeling with
relevant information to patients or potential patients for biological
products approved under part 601, subpart H when human efficacy studies
are not ethical or feasible (or based on evidence of effectiveness from
studies in animals). Section 601.93 provides that biological products
approved under subpart H are subject to the postmarketing recordkeeping
and safety reporting applicable to all approved biological products.
Section 601.94 requires applicants under subpart H to submit to the
agency for consideration during preapproval review period copies of all
promotional materials including promotional labeling as well as
advertisements.

    Under Sec.  601.93, any potential postmarketing reports and/or
recordkeeping burdens would be included under the adverse experience
reporting (AER) requirements under part 600 (21 CFR part 600) (OMB
Control No. 0910-0308). Therefore, any burdens associated with these
requirements would be reported under the AER information collection
requirements (OMB Control No. 0910-0308).
    Section 610.9(a) requires the applicant to present certain
information, in the form of a license application or supplement to the
application, for a modification of any particular test method or
manufacturing process or the conditions which it is conducted under the
biologics regulations. The burden estimate for Sec.  610.9(a) is
included in the estimate under Sec. Sec.  601.2(a) and 601.12(b) and
(c) in table 1 of this document.
    Section 610.11(g)(2) provides that a manufacturer of certain
biological products may request an exemption from the general safety
test (GST) requirements contained in subpart H. Under Sec.
610.11(g)(2), FDA requires only those manufacturers of biological
products requesting an exemption from the GST to submit additional
information as part of a license application or supplement to an
approved license application. Therefore, the burden estimate for Sec.
610.11(g)(2) is included in the estimate under Sec. Sec.  601.2(a) and
601.12(b) in table 1 of this document.
    Section 640.120 requires licensed establishments to submit a
request for an exception or alternative to any requirement in the
biologics regulations regarding blood, blood components, or blood
products. A request for an exception or alternative must be submitted
in accordance with Sec.  601.12; therefore the burden estimate for
Sec.  640.120 is included in the estimate under Sec.  601.12(b) in
table 1 of this document.
    Section 680.1(c) requires manufacturers to update annually their
license file with the list of source materials and the suppliers of the
materials. Section 680.1(b)(3)(iv) requires manufacturers to notify FDA
when certain diseases are detected in source materials.
    Sections 600.15(b) and 610.53(d) (21 CFR 610.53(d)) require the
submission of a request for an exemption or modification regarding the
temperature requirements during shipment and from dating periods,
respectively, for certain biological products. Section 606.110(b) (21
CFR 606.110(b)) requires the submission of a request for approval to
perform plasmapheresis of donors who do not meet certain donor
requirements for the collection of plasma containing rare antibodies.
Under Sec. Sec.  600.15(b), 610.53(d), and 606.110(b), a request for an
exemption or modification to the requirements would be submitted as a
supplement. Therefore, the burden hours for any submissions under
Sec. Sec.  600.15(b), 610.53(d), and 606.110(b) are included in the
estimates under Sec.  601.12(b) in table 1 of this document.
    In July 1997, FDA revised Form FDA 356h ``Application to Market a
New Drug, Biologic, or an Antibiotic Drug for Human Use'' to harmonize
application procedures between CBER and CDER. The application form
serves primarily as a checklist for firms to gather and submit certain
information to FDA. The checklist helps to ensure that the application
is complete and contains all the necessary information, so that delays
due to lack of information may be eliminated. The form provides key
information to FDA for efficient handling and distribution to the
appropriate staff for review. The estimated burden hours for
nonbiological product submissions to CDER using FDA Form 356h are
approved under OMB Control No. 0910-0001.
    Form FDA 2567 ``Transmittal of Labels and Circulars'' is used by
manufacturers of licensed biological products to submit labeling (e.g.,
circulars, package labels, container labels, etc.) and labeling changes
for FDA review and approval. The labeling information is submitted with
the form for license applications, supplements, or as part of an annual
report. Form FDA 2567 is also used for the transmission of
advertisements and promotional labeling. Form FDA 2567 serves as an
easy guide to assure that the manufacturer has provided the information
required for expeditious handling of their labeling by CBER. For
advertisements and promotional labeling, manufacturers of licensed
biological products may submit to CBER either Form FDA 2567 or 2253.
Form FDA 2253 was previously used only by drug manufacturers regulated
by CDER. In August of 1998, FDA revised and harmonized Form FDA 2253 so
the form may be used to transmit specimens of promotional labeling and
advertisements for biological products as well as for prescription
drugs and antibiotics. The revised, harmonized form updates the
information about the types of promotional materials and the codes that
are used to clarify the type of advertisement or labeling submitted;
clarifies the intended audience for the advertisements or promotional
labeling (e.g., consumers, professionals, news services); and helps
ensure that the submission is complete. Form FDA 2253 is approved under
OMB Control No. 0910-0001.
    Under table 1 of this document, the number of respondents is based
on the estimated annual number of manufacturers that submitted the
required information to FDA or the number of submissions FDA received
in fiscal year 2008. Based on information obtained from FDA's database
systems, there are an estimated 301 licensed biologics manufacturers.
The total annual responses are based on the estimated number of
submissions (i.e., license applications, labeling and other
supplements, protocols, advertising and promotional labeling,
notifications) for a particular product received annually by FDA. Based
on previous estimates, the rate of submissions is not expected to
change significantly in the next few years. The hours per response are
based on information provided by industry and past FDA experience with
the various submissions or notifications. The hours per response
include the time estimated to prepare the various submissions or
notifications to FDA, and, as applicable, the time required to fill out
the appropriate form and collate the documentation. Additional
information regarding these estimates is provided in this document as
necessary.
    Under Sec. Sec.  601.2 and 601.12, the estimated hours per response
are based on the average number of hours to submit the various
submissions. The estimated average number of hours is based on the
range of hours to complete a very basic application or supplement and a
complex application or supplement.
    Under Sec.  601.6(a), the total annual responses are based on FDA
estimates that establishments may notify an average of 20 selling
agents and distributors of such suspension, and provide FDA of such
notification. The number of respondents is based on the estimated
annual number of suspensions of a biologic license.
    Under Sec. Sec.  601.12(f)(4) and 601.45, manufacturers of
biological products may use either Form FDA 2567 or Form FDA 2253 to
submit advertising and promotional labeling. Based on information
obtained from FDA's database system, there were an estimated 4,452
submissions of advertising and promotional labeling. FDA estimates that
approximately 15 percent of those submissions were received with Form
FDA 2567 and 85 percent were received with Form 2253.
    Under Sec. Sec.  601.28 and 601.70(b), FDA estimates that it takes
an applicant approximately 24 hours (8 hours per study x 3 studies)
annually to gather,

complete, and submit the appropriate information for each postmarketing
status report (approximately two to four studies per report) and the
accompanied transmittal Form FDA 2252. Included in these 24 hours is
the time necessary to prepare and submit two copies of the annual
progress report of postmarketing studies to FDA under Sec.  601.70(d).
    Under Sec. Sec.  601.91 through 601.94, FDA expects to receive very
few applications for these products; however, for calculation purposes,
FDA is estimating the annual submission of one application. Under
Sec. Sec.  601.93(b)(3) and 601.94, FDA estimates 240 hours for a
manufacturer of a new biological product to develop patient labeling,
and to submit the appropriate information and promotional labeling to
FDA. The majority of the burden for developing the patient labeling is
included under the reporting requirements for Sec.  601.94, therefore
minimal burden is calculated for providing the guide to patients under
Sec.  601.91(b)(3).
    There were a total of 5,338 amendments to an unapproved application
or supplement and resubmissions submitted using Form FDA 356h.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                  No. of       Annual Frequency     Total Annual        Hours per
             21 CFR Section                  Form FDA No.      Respondents       per Response        Responses           Response         Total Hours
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601.2(a)\2\ and 610.60 through 610.65\3\          2567/356h               23                  2                 46                860             39,560
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601.5(a)                                                N/A               11                  3                 33         20 minutes                 11
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601.6(a)                                                N/A                1                 21                 21         20 minutes                  7
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601.12(a)(5)                                            N/A              802                  9              7,218                  1              7,218
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601.12(b)(1), (b)(3), and (e)\4\                    356h\2\              166                  5                830                 80             66,400
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601.12(c)(1) and (c)(3)\5\                          356h\2\              141                  5                705                 50             35,250
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601.12(c)(5)                                        356h\2\               42                  5                210                 50             10,500
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601.12(d)(1), (d)(3), and (f)(3)\7\                 356h\2\              246                  3                738                 23             16,974
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601.12(f)(1)\6\                                        2567              112                  2                224                 40              8,960
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601.12(f)(2)\6\                                        2567               53                  3                159                 20              3,180
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601.12(f)(4) and 601.45                           2567/2253               42                106              4,452                 10             44,520
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601.26(f)                                               N/A                1                  1                  1                  1                  1
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601.27(b)                                               N/A                6                  1                  6                 24                144
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601.27(c)                                               N/A               10                  1                 10                  8                 80
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601.70(b), (d), and 601.28                             2252               39                  2                 78                 24              1,872
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601.91(b)(3) and 601.94                                 N/A                1                  1                  1                240                240
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680.1(c)                                                N/A                9                  1                  9                  2                 18
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680.1(b)(3)(iv)                                         N/A                1                  1                  1                  2                  2
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Amendments/Resubmissions                               356h              314                 17              5,338                 20            106,760
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Total                                                                                341,697
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The reporting requirements under Sec.  Sec.   610.9(a), 601.14, 601.27(a), 601.33, 601.34, 601.35, 610.11(g)(2), 640.17, 640.25(c), 640.56(c),
  640.74(b)(2), 660.51(a)(4), and 680.1(b)(2)(iii) are included in the estimate under Sec.   601.2(a).
\3\ The reporting requirements under Sec.  Sec.   640.70(a), 640.74(b)(3) and (b)(4), 640.84(a) and (c), 640.94(a), 660.2(c), 660.28(a), (b), and (c),
  660.35(a), (c) through (g), and (i) through (m), 660.45, and 660.55(a) and (b) are included under Sec.  Sec.   610.60 through 610.65.
\4\ The reporting requirements under Sec.  Sec.   610.9(a), 600.15(b), 610.11(g)(2), 610.53(d), 606.110(b), 640.6, 640.17, 640.21(c), 640.22(c),
  640.25(c), 640.56(c), 640.64(c), 640.74(a) and (b)(2), 640.120, and 680.1(d) are included in the estimate under Sec.   601.12(b).
\5\ The reporting requirements under Sec.  Sec.   610.9(a), 640.17, 640.25(c), 640.56(c), and 640.74(b)(2) are included in the estimate under Sec.
  601.12(c).
\6\ The reporting requirement under Sec.   601.14 is included in the estimate under Sec.   601.12(f)(1) and (f)(2).
\7\ The reporting requirement under Sec.   601.14 is included in the estimate under Sec.   601.12(f)(3).

    Under table 2, the estimated recordkeeping burden of 1 hour is
based on previous estimates for the recordkeeping requirements
associated with the AER system.

                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                              No. of         Annual Frequency       Total Annual
                    21 CFR Section                        Recordkeepers      per Recordkeeping        Records        Hours per Record     Total Hours
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601.91(b)(2)(iii)                                                       1                     1                  1                  1                  1
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\1\ There are no capital costs or operating costs associated with this collection of information.

    Dated: January 20, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-1439 Filed 1-25-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 81, Number 206 (Tuesday, October 25, 2016)]
[Proposed Rules]
[Page 73368]
[FR Doc No: 2016-25303]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 272

[EPA-R06-RCRA-2014-0791; FRL-9951-73-Region 6]

Oklahoma: Incorporation by Reference of State Hazardous Waste
Management Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) proposes to codify
in the regulations entitled ``Approved State Hazardous Waste Management
Programs'', Oklahoma's authorized hazardous waste program. The EPA will
incorporate by reference into the Code of Federal Regulations (CFR)
those provisions of the State regulations that are authorized and that
the EPA will enforce under the Solid Waste Disposal Act, commonly
referred to as the Resource Conversation and Recovery Act (RCRA).

DATES: Send written comments by November 25, 2016.

ADDRESSES: Submit any comments identified by Docket ID No. EPA-R06-
RCRA-2014-0791, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow
the on-line instructions for submitting comments.
    2. Email<EMAIL_ADDRESS>or<EMAIL_ADDRESS>    3. Mail: Alima Patterson, Region 6, Regional Authorization
Coordinator, or Julia Banks, Codification Coordinator, Permit Section
(RPM), Multimedia Planning and Permitting Division, EPA Region 6, 1445
Ross Avenue, Dallas, Texas 75202-2733.
    4. Hand Delivery or Courier: Deliver your comments to Alima
Patterson, Region 6, Regional Authorization Coordinator, or Julia
Banks, Codification Coordinator, Permit Section RPM), Multimedia
Planning and Permitting Division, EPA Region 6, 1445 Ross Avenue,
Dallas, Texas 75202-2733.
    Instructions: Do not submit information that you consider to be
Confidential Business Information (CBI) or otherwise protected through
regulations.gov, or email. Direct your comments to Docket ID No. EPA-
R06-RCRA-2014-0791. The Federal regulations.gov Web site is an
``anonymous access'' system, which means the EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to the EPA without
going through regulations.gov, your email address will be automatically
captured and included as part of the comment that is placed in the
public docket and made available on the Internet. If you submit an
electronic comment, the EPA recommends that you include your name and
other contact information in the body of your comment and with any disk
or CD-ROM you submit. If the EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, the
EPA may not be able to consider your comment. Electronic files should
avoid the use of special characters, any form of encryption, and be
free of any defects or viruses. You can view and copy the documents
that form the basis for this authorization and codification and
associated publicly available materials from 8:30 a.m. to 4 p.m. Monday
through Friday at the following location: EPA Region 6, 1445 Ross
Avenue, Dallas, Texas 75202-2733, phone number:<PHONE_NUMBER> or (214)
665-8178. Interested persons wanting to examine these documents should
make an appointment with the office at least two weeks in advance.

FOR FURTHER INFORMATION CONTACT: Alima Patterson, Region 6, Regional
Authorization Coordinator or Julia Banks, Codification Coordinator,
Permit Section (RPM), Multimedia Planning and Permitting Division, EPA
Region 6, 1445 Ross Avenue, Dallas, Texas 75202-2733, Phone number:
(214) 665-8533 or<PHONE_NUMBER>, and Email address:
<EMAIL_ADDRESS>or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the ``Rules and Regulations'' section of
this Federal Register (FR), the EPA is codifying and incorporating by
reference the State's hazardous waste program as direct final rule. The
EPA did not make a proposal prior to the direct final rule because we
believe these actions are not controversial and do not expect comments
that oppose them. We have explained the reasons for this codification
and incorporation by reference in the preamble to the direct final
rule. Therefore, the purpose of this FR document is to codify
Oklahoma's base hazardous waste management program and its program
revisions through RCRA Cluster XXI (see 78 FR 32161) May 29, 2013. The
EPA provided notices and opportunity for comments on the Agency's
decisions to authorize the Oklahoma program, and the EPA is not now
reopening the decisions, nor requesting comments, on the Oklahoma
authorizations as published in the FR notices specified in Section B of
the direct final rule FR document.
    This document incorporates by reference Oklahoma's hazardous waste
statutes and regulations and clarifies which of these provisions are
included in the authorized and federally enforceable program. By
codifying Oklahoma's authorized program and by amending the Code of
Federal Regulations, the public will be more easily able to discern the
status of federally approved requirements of the Oklahoma hazardous
waste management program.

    Dated: August 1, 2016.
 Ron Curry,
Regional Administrator, EPA Region 6.
[FR Doc. 2016-25303 Filed 10-24-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 20 (Friday, January 30, 2015)]
[Notices]
[Pages 5111-5113]
[FR Doc No: 2015-01784]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9922-12-OGC]

Proposed Settlement Agreement

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Proposed Settlement Agreement; Request for Public
Comment.

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SUMMARY: In accordance with section 113(g) of the Clean Air Act, as
amended (``Act''), notice is hereby given of a proposed settlement
agreement to address lawsuits filed by Cliffs Natural Resources Inc.
(``Cliffs''), ArcelorMittal USA LLC (``ArcelorMittal''), the State of
Michigan (collectively, the ``Petitioners'') in the United States Court
of Appeals for the Eighth Circuit: Cliffs Natural Resources Inc., et
al., v. EPA, No. 13-1758 (and consolidated case Nos. 13-1761, 13-2126,
13-2129, 13-2130) and Cliffs Natural Resources Inc., et al., v. EPA,
No. 13-3573 (and consolidated case Nos. 13-3575, 14-1710, and 14-1712).
Petitioners filed petitions for review challenging EPA's final rule
entitled ``Approval and Promulgation of Air Quality Implementation
Plans; States of Minnesota and Michigan; Regional Haze State
Implementation Plan; Federal Implementation Plan for Regional Haze'' 78
FR 8706 (Feb. 6, 2013) (the ``FIP Rule''). Petitioners also filed
petitions for review challenging EPA's final rule entitled ``Approval
and Promulgation of Air Quality Implementation Plans; States of
Michigan and Minnesota; Regional Haze,'' 78 FR 59825 (Sept. 30, 2013)
(the ``SIP Rule''). The proposed settlement agreement establishes
deadlines for EPA to take actions.

DATES: Written comments on the proposed settlement agreement must be
received by March 2, 2015.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-HQ-
OGC-2015-0003, online at www.regulations.gov (EPA's preferred method);
by email to<EMAIL_ADDRESS>by mail to EPA Docket Center,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001; or by hand delivery or courier to
EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday,
excluding legal holidays. Comments on a disk or CD-ROM should be
formatted in Word or ASCII file, avoiding the use of special characters
and any form of encryption,

and may be mailed to the mailing address above.

FOR FURTHER INFORMATION CONTACT: Matthew C. Marks, Air and Radiation
Law Office (2344A), Office of General Counsel, U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460;
telephone:<PHONE_NUMBER> fax number<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Additional Information About the Proposed Settlement Agreement

    The proposed settlement agreement will resolve lawsuits seeking
review of EPA's final rules entitled ``Approval and Promulgation of Air
Quality Implementation Plans; States of Minnesota and Michigan;
Regional Haze State Implementation Plan; Federal Implementation Plan
for Regional Haze'' 78 FR 8706 (Feb. 6, 2013) (the ``FIP Rule''), and
EPA's final rule entitled ``Approval and Promulgation of Air Quality
Implementation Plans; States of Michigan and Minnesota; Regional
Haze,'' 78 FR 59825 (Sept. 30, 2013) (the ``SIP Rule''). Petitioners
have raised various challenges to the FIP Rule and the SIP Rule
associated with taconite facilities located in Minnesota and Michigan.
    The proposed settlement agreement states that, no later than June
12, 2015, EPA will sign a notice of proposed rulemaking proposing
changes to the FIP Rule that are substantially consistent with, and
include numeric emission limits and time frames identical to those set
forth in, Attachment A to the Settlement Agreement. The proposed
settlement agreement also states that, if EPA signs by December 18,
2015, a final rule amending the FIP Rule that is substantially
consistent with, and includes numeric emission limits and time frames
identical to those set forth in, Attachment A to the Settlement
Agreement, then Petitioners and EPA shall promptly file an appropriate
pleading for the dismissal of Case Nos. 13-1758, 13-1761, 13-2126, 13-
2129, 13-2130, 13-3573, 13-3575, 14-1710, and 14-1712 with prejudice,
with each party to bear its own costs and attorneys' fees. The proposed
settlement agreement further states that Petitioners waive any right to
challenge in any court or administrative proceeding any portion of that
final rule that is substantially consistent with, and includes numeric
emission limits and time frames identical to those set forth in,
Attachment A to the Settlement Agreement. Finally, the proposed
settlement agreement states that nothing in the agreement shall be
construed to limit or modify the discretion accorded EPA by the Act or
by general principles of administrative law.
    For a period of thirty (30) days following the date of publication
of this notice, the Agency will accept written comments relating to the
proposed settlement agreement from persons who were not named as
parties or intervenors to the litigation in question. EPA or the
Department of Justice may withdraw or withhold consent to the proposed
settlement agreement if the comments disclose facts or considerations
that indicate that such consent is inappropriate, improper, inadequate,
or inconsistent with the requirements of the Act. Unless EPA or the
Department of Justice determines that consent to this settlement
agreement should be withdrawn, the terms of the agreement will be
affirmed.

 II. Additional Information About Commenting on the Proposed Settlement
Agreement

A. How can I get a copy of the settlement agreement?

    The official public docket for this action (identified by Docket ID
No. EPA-HQ-OGC-2015-0003) contains a copy of the proposed settlement
agreement. The official public docket is available for public viewing
at the Office of Environmental Information (OEI) Docket in the EPA
Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC. The EPA Docket Center 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 (202)
566-1744, and the telephone number for the OEI Docket is (202) 566-
1752.
    An electronic version of the public docket is available through
www.regulations.gov. You may use the www.regulations.gov to submit or
view public comments, access the index listing of the contents of the
official public docket, and to access those documents in the public
docket that are available electronically. Once in the system, key in
the appropriate docket identification number then select ``search''.
    It is important to note that EPA's policy is that public comments,
whether submitted electronically or in paper, will be made available
for public viewing online at www.regulations.gov without change, unless
the comment contains copyrighted material, CBI, or other information
whose disclosure is restricted by statute. Information claimed as CBI
and other information whose disclosure is restricted by statute is not
included in the official public docket or in the electronic public
docket. EPA's policy is that copyrighted material, including
copyrighted material contained in a public comment, will not be placed
in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the EPA Docket
Center.

B. How and to whom do I submit comments?

    You may submit comments as provided in the ADDRESSES section.
Please ensure that your comments are submitted within the specified
comment period. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.
    If you submit an electronic comment, EPA recommends that you
include your name, mailing address, and an email address or other
contact information in the body of your comment and with any disk or CD
ROM you submit. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. Any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
    Use of the www.regulations.gov Web site to submit comments to EPA
electronically is EPA's preferred method for receiving comments. The
electronic public docket system is an ``anonymous access'' system,
which means EPA will not know your identity, email address, or other
contact information unless you provide it in the body of your comment.
In contrast to EPA's electronic public docket, EPA's electronic mail
(email) system is not an ``anonymous access'' system. If you send an
email comment directly to the Docket without going through
www.regulations.gov, your email address is automatically captured and
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.

    Dated: January 22, 2015.
Lorie J. Schmidt,
Associate General Counsel.
[FR Doc. 2015-01784 Filed 1-29-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Notices]
[Pages 23339-23342]
[FR Doc No: 2016-09062]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77620; File No. SR-BATS-2015-124]

Self-Regulatory Organizations; BATS Exchange, Inc.; Order
Granting Approval of a Proposed Rule Change, as Modified by Amendment
Nos. 1, 2, and 5, To List and Trade Shares of the REX VolMAXX Long VIX
Weekly Futures Strategy ETF and the REX VolMAXX Inverse VIX Weekly
Futures Strategy ETF of the Exchange Traded Concepts Trust

April 14, 2016.

I. Introduction

    On December 30, 2015, BATS Exchange, Inc. (``Exchange'' or
``BATS'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to list and trade shares (``Shares'') of the REX
VolMAXX Long VIX Weekly Futures Strategy ETF and the REX VolMAXX
Inverse VIX Weekly Futures Strategy ETF (each a ``Fund'' and
collectively, ``Funds'') of the Exchange Traded Concepts Trust
(``Trust'') under BATS Rule 14.11(i). The proposed rule change was
published for comment in the Federal Register on January 20, 2016.\3\
On February 10, 2016, the Exchange filed Amendment No. 1 to the
proposed rule change, and on February 12, 2016, the Exchange filed
Amendment No. 2 to the proposed rule change.\4\ On March 3, 2016,
pursuant to Section 19(b)(2) of the Act,\5\ the Commission designated a
longer period within which to approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether to disapprove the proposed rule change.\6\ On March
28, 2016, the Exchange filed Amendment No. 5 to the proposed rule
change.\7\ The Commission received no comments on the proposed rule
change. This order grants approval of the proposed rule change, as
modified by Amendment Nos. 1, 2, and 5.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 76884 (January 13,
2016), 81 FR 3195 (``Notice'').
    \4\ On March 22, 2016, the Exchange filed Amendment No. 3 to the
proposed rule change. On March 28, 2016, the Exchange withdrew
Amendment No. 3 and filed and withdrew Amendment No. 4 to the
proposed rule change.
    \5\ 15 U.S.C. 78s(b)(2).
    \6\ See Securities Exchange Act Release No. 77287, 81 FR 12540
(March 9, 2016).
    \7\ Amendment No. 5 replaced Amendment No. 1 (as subsequently
amended by Amendment No. 2), which replaced and superseded the
original filing in its entirety. In Amendment No. 5, the Exchange:
(1) Provided additional clarification and specificity regarding the
instruments in which the Funds may invest, including that the Funds
will not invest in leveraged (e.g., 2X, -2X, 3X or -3X) investment
company securities; (2) provided additional clarification regarding
the investment objective and investment restrictions of the
Subsidiaries; (3) clarified how certain investments will be valued
for computing each Fund's net asset value; (4) clarified where price
information can be obtained for certain investments of the Funds;
(5) supplemented the description of the information that will be
contained in the Information Circular; (6) clarified that all
statements and representations made in the filing regarding the
description of the portfolio, limitations on portfolio holdings or
reference assets, or the applicability of Exchange rules and
surveillance procedures constitute continued listing requirements
for listing the Shares on the Exchange; (7) stated that the issuer
has represented to the Exchange that it will advise the Exchange of
any failure by the Funds to comply with the continued listing
requirements, and, pursuant to its obligations under Section
19(g)(1) of the Act, the Exchange will surveil for compliance with
the continued listing requirements, and if a Fund is not in
compliance with the applicable listing requirements, the Exchange
will commence delisting procedures under Exchange Rule 14.12; and
(8) made other technical amendments. Because Amendment No. 5 does
not materially alter the substance of the proposed rule change or
raise unique or novel regulatory issues, Amendment No. 5 is not
subject to notice and comment. Amendment No. 5 is available at
http://www.sec.gov/comments/sr-bats-2015-124/bats2015124-5.pdf.
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II. The Exchange's Description of the Proposal

    The Exchange proposes to list and trade the Shares of the Funds
under BATS Rule 14.11(i), which governs the listing and trading of
Managed Fund Shares on the Exchange. The Shares will be offered by the
Trust. According to the Exchange, the Trust is registered with the
Commission as an open-end investment company and has filed a
registration statement on behalf of the Funds on Form N-1A
(``Registration Statement'') with the Commission.\8\ Exchange Traded
Concepts, LLC will be the investment adviser (``Adviser'') \9\ to the
Funds and Vident Investment Advisory, LLC will be the sub-adviser
(``Sub-Adviser'') to the Funds.\10\ SEI Investments Global Funds
Services serves as administrator for the Trust (``Administrator'');
Brown Brothers Harriman & Co. serves as custodian, transfer agent, and
dividend disbursing agent for the Trust; and SEI Investments
Distribution Co. serves as the distributor for the Trust.\11\
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    \8\ See Registration Statement on Form N-1A for the Trust, dated
December 29, 2015 (File Nos. 333-156529 and 811-22263). The Exchange
states that the Commission has issued an order granting certain
exemptive relief to the Trust under the Investment Company Act of
1940 (``1940 Act''). See Investment Company Act Release No. 30445
(April 2, 2013) (File No. 812-13969).
    \9\ The Exchange states that the Adviser is registered as a
Commodity Pool Operator and that the Funds and their respective
Subsidiaries (as defined below) will be subject to regulation by the
Commodity Futures Trading Commission and to additional disclosure,
reporting, and recordkeeping rules imposed upon commodity pools.
    \10\ The Exchange states that neither the Adviser nor the Sub-
Adviser is registered as a broker-dealer or is affiliated with a
broker-dealer. The Exchange states that in the event that (a) the
Adviser or Sub-Adviser becomes a broker-dealer or newly affiliated
with a broker-dealer, or (b) any new adviser or sub-adviser is a
broker-dealer or becomes affiliated with a broker-dealer, it will
implement a fire wall with respect to its relevant personnel or such
broker-dealer affiliate, as applicable, regarding access to
information concerning the composition and/or changes to the
portfolio, and will be subject to procedures designed to prevent the
use and dissemination of material non-public information regarding
such portfolio.
    \11\ The Commission notes that additional information regarding
the Trust, the Funds, and the Shares, including investment
strategies, risks, creation and redemption procedures, calculation
of net asset value (``NAV''), fees, portfolio holdings disclosure
policies, distributions, and taxes, among other things, can be found
in the Notice, Amendment No. 5, and the Registration Statement, as
applicable. See Notice, supra note 3, Amendment No. 5, supra note 7,
and Registration Statement, supra note 8.
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A. The Funds' Investments

    According to the Exchange, the REX VolMAXX Long VIX Weekly Futures
Strategy ETF seeks to provide investors with long exposure to the
implied volatility of the broad-based, large-cap U.S. equity market by
obtaining investment exposure to an actively managed portfolio of
exchange-traded futures contracts based on the Chicago Board Options
Exchange, Incorporated (``CBOE'') Volatility Index (``VIX Index'')
(such futures contracts, ``VIX Futures Contracts'') with weekly and
monthly expirations. According to the Exchange, the REX VolMAXX Inverse
VIX Weekly Futures Strategy ETF seeks to provide investors with inverse
exposure to the implied volatility of the broad-based, large-cap U.S.
equity market by obtaining investment exposure to an actively managed
portfolio of exchange-traded VIX Futures Contracts with weekly and
monthly expirations.\12\
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    \12\ The Exchange represents that while the REX VolMAXX Long VIX
Weekly Futures Strategy ETF generally will seek exposure to the VIX
Index and the REX VolMAXX Inverse VIX Weekly Futures Strategy ETF
generally will seek inverse exposure to the VIX Index, the Funds are
not index tracking funds and will generally seek to enhance their
performance by actively selecting VIX Futures Contracts of varying
maturities and they can be expected to perform very differently from
the VIX Index over all periods of time.
---------------------------------------------------------------------------

    According to the Exchange, each Fund will seek to achieve its
investment objective by obtaining investment exposure to an actively
managed portfolio of futures contracts based on VIX Futures Contracts
with weekly and

monthly expirations.\13\ The Exchange states that each Fund will obtain
such exposure by investing, through both long and short positions, only
in the following instruments: VIX Futures Contracts; \14\ total return
swap agreements that provide exposure to VIX Futures Contracts; \15\
the securities of other investment companies,\16\ other pooled
investment vehicles,\17\ and exchange-traded notes \18\ that provide
exposure to VIX Futures Contracts; options on securities, securities
indices, and currencies; \19\ repurchase agreements \20\ and reverse
repurchase agreements; \21\ and cash or cash equivalents (which include
commercial paper \22\ and U.S. government obligations \23\) to
collateralize its exposure to the VIX Futures Contracts and for
investment purposes.
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    \13\ According to the Exchange, the REX VolMAXX Long VIX Weekly
Futures Strategy ETF expects the notional value of its exposure to
VIX Futures Contracts to be equal to approximately 100% of its
assets at all times and the weighted average of time to expiry of
the VIX Futures Contracts to be less than one month at all times.
The REX VolMAXX Inverse VIX Weekly Futures Strategy ETF expects the
notional value of its exposure to VIX Futures Contracts to be equal
to approximately 100% of its assets at the close of each trading day
and the weighted average of time to expiry of the VIX Futures
Contracts to be less than one month at all times.
    \14\ The Exchange represents that all VIX Futures Contracts held
by the Funds will be exchange-traded.
    \15\ The Exchange states that to the extent practicable, each
Fund will invest in swaps cleared through the facilities of a
centralized clearing house. The Exchange also states that, to the
extent that a Fund invests in swaps that are not centrally cleared,
the Adviser will attempt to mitigate the Fund's credit risk by
transacting only with large, well-capitalized institutions using
measures designed to determine the creditworthiness of a
counterparty. According to the Exchange, the Adviser will take
various steps to limit counterparty credit risk. The Exchange
represents that each Fund's investments in over-the-counter
(``OTC'') derivatives will not exceed 20% of its assets.
    \16\ Each Fund may invest in the securities of other investment
companies, subject to applicable limitations under Section 12(d)(1)
of the 1940 Act. These securities include only the following: The
securities of exchange-traded investment companies including
Portfolio Depositary Receipts (as defined in BATS Rule 14.11(b));
Index Fund Shares (as defined in BATS Rule 14.11(c)); and Managed
Fund Shares (as defined in BATS Rule 14.11(i)); and money market
mutual funds. The Exchange represents that although the Funds may
invest in inverse investment company securities, the Funds will not
invest in leveraged (e.g., 2X, -2X, 3X or -3X) investment company
securities.
    \17\ According to the Exchange, pooled investment vehicles
include only the following instruments: Trust Issued Receipts (as
defined in BATS Rule 14.11(f)); Commodity-Based Trust Shares (as
defined in Rule 14.11(e)(4)); Currency Trust Shares (as defined in
Rule 14.11(e)(5)); Commodity Index Trust Shares (as defined in Rule
14.11(e)(6)); Trust Units (as defined in Rule 14.11(e)(9)); and
Paired Class Shares (as defined in NASDAQ Stock Market LLC Rule
5713). The Exchange represents that although the Funds may invest in
inverse pooled investment vehicles, the Funds will not invest in
leveraged (e.g., 2X, -2X, 3X or -3X) pooled investment vehicles.
    \18\ The Exchange represents that although the Funds may invest
in inverse ETNs, the Funds will not invest in leveraged (e.g., 2X, -
2X, 3X or -3X) ETNs.
    \19\ The Exchange states that all options written on indices or
securities will be covered. According to the Exchange, for all OTC
options, the Funds will seek, where possible, to use counterparties
whose financial status is such that the risk of default is reduced;
however, the risk of losses from default is still possible. The
Exchange represents that the Sub-Adviser will monitor the financial
standing of counterparties on an ongoing basis.
    \20\ According to the Exchange, the Funds follow certain
procedures designed to minimize the risks inherent in repurchase
agreements. The Exchange represents that it is the current policy of
each Fund not to invest in repurchase agreements that do not mature
within seven days if any such investment, together with any other
illiquid assets held by the Fund, amount to more than 15% of the
Fund's net assets. The Exchange states that the investments of the
Funds in repurchase agreements, at times, may be substantial when,
in the view of the Sub-Adviser, liquidity or other considerations so
warrant.
    \21\ According to the Exchange, each Fund will establish a
segregated account with the Trust's custodian bank in which the Fund
will maintain cash, cash equivalents or other portfolio securities
equal in value to its obligations in respect of reverse repurchase
agreements. The Exchange represents that each Fund does not expect
to engage, under normal circumstances, in reverse repurchase
agreements with respect to more than 33\1/3\% of its assets.
    \22\ The Exchange states that the Funds may invest in commercial
paper rated A-1 or A-2 by Standard and Poor's Ratings Services or
Prime-1 or Prime-2 by Moody's Investors Service, Inc.
    \23\ U.S. government obligations include securities issued or
guaranteed as to principal and interest by the U.S. government, its
agencies, or instrumentalities, such as U.S. Treasury obligations,
receipts, STRIPS, and U.S. Treasury zero-coupon bonds.
---------------------------------------------------------------------------

    Each of the REX VolMAXX Long VIX Weekly Futures Strategy ETF and
the REX VolMAXX Inverse VIX Weekly Futures Strategy ETF expects to gain
exposure to certain of these investments by investing a portion of its
assets in its wholly-owned Cayman Islands subsidiary, the REX VolMAXX
Long VIX Weekly Futures Strategy Subsidiary I and the REX VolMAXX
Inverse VIX Weekly Futures Strategy Subsidiary I, respectively (each a
``Subsidiary'' and, collectively, ``Subsidiaries''). The Subsidiaries
will be advised by the Adviser.\24\ According to the Exchange, each
Fund's investment in its Subsidiary is intended to provide the Fund
with exposure to markets within the limits of current federal income
tax laws applicable to investment companies such as the Funds, which
limit the ability of investment companies to invest directly in certain
futures contracts. According to the Exchange, each Subsidiary will have
the same investment objective and investment restrictions as its
applicable Fund and, except as otherwise noted, references to each
Fund's investments may also be deemed to include the Fund's indirect
investments through its Subsidiary. Each Fund will invest up to 25% of
its total assets in its Subsidiary.
---------------------------------------------------------------------------

    \24\ The Exchange states that the Subsidiaries are not
registered under the 1940 Act and are not directly subject to its
investor protections, except as noted in the Registration Statement.
However, according to the Exchange, each Subsidiary is wholly-owned
and controlled by its respective Fund and is advised by the Adviser.
Therefore, according to the Exchange, because of each Fund's
ownership and control of its Subsidiary, the Subsidiary will not
take action contrary to the interests of its respective Fund or its
shareholders. Each Fund's Board of Trustees (``Board'') has
oversight responsibility for the investment activities of the Fund,
including the Fund's expected investment in its Subsidiary, and the
Fund's role as the sole shareholder of the Subsidiary. The Adviser
receives no additional compensation for managing the assets of the
Subsidiaries. The Exchange states that each Subsidiary will enter
into separate contracts for the provision of custody, transfer
agency, and accounting agent services with the same or with
affiliates of the same service providers that provide those services
to the applicable Fund.
---------------------------------------------------------------------------

    Each Fund may lend its portfolio securities in an amount not to
exceed 33\1/3\% of the value of its total assets, and each Fund will
receive collateral for each loaned security which is at least equal to
the current market value of that security, marked to market each
trading day. The Exchange represents that aside from each Fund's
investments in its Subsidiary, each Fund and its Subsidiary will not
invest in non-U.S. equity securities or options.
    Each Fund intends to qualify each year as a regulated investment
company under the Internal Revenue Code.

B. The Funds' Investment Restrictions

    Each Fund may hold up to an aggregate amount of 15% of its net
assets in illiquid assets (calculated at the time of investment) deemed
illiquid by the Adviser \25\ under the 1940 Act. Each Fund will monitor
its portfolio liquidity on an ongoing basis to determine whether, in
light of current circumstances, an adequate level of liquidity is being
maintained, and will consider taking appropriate steps in order to
maintain adequate liquidity if, through a change in values, net assets,
or other circumstances, more than 15% of the Fund's net assets are held
in illiquid assets. Illiquid assets include assets subject to
contractual or other restrictions on resale and other instruments that
lack readily available

markets as determined in accordance with Commission staff guidance.
---------------------------------------------------------------------------

    \25\ The Exchange states that, in reaching liquidity decisions,
the Adviser may consider the following factors: The frequency of
trades and quotes for the security; the number of dealers wishing to
purchase or sell the security and the number of other potential
purchasers; dealer undertakings to make a market in the security;
and the nature of the security and the nature of the marketplace in
which it trades (e.g., the time needed to dispose of the security,
the method of soliciting offers, and the mechanics of transfer).
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    Each Fund's investments will be consistent with the Fund's
investment objective and will not be used to achieve leveraged or
inverse leveraged returns.

III. Discussion and Commission Findings

    After careful review, the Commission finds that the Exchange's
proposal to list and trade the Shares is consistent with the Act and
the rules and regulations thereunder applicable to a national
securities exchange.\26\ In particular, the Commission finds that the
proposed rule change, as modified by Amendment Nos. 1, 2, and 5, is
consistent with Section 6(b)(5) of the Act,\27\ which requires, among
other things, that the Exchange's rules be designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest.
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    \26\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \27\ 15 U.S.C. 78f(b)(5).
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    The Commission also finds that the proposal to list and trade the
Shares on the Exchange is consistent with Section 11A(a)(1)(C)(iii) of
the Act,\28\ which sets forth Congress's finding that it is in the
public interest and appropriate for the protection of investors and the
maintenance of fair and orderly markets to assure the availability to
brokers, dealers, and investors of information with respect to
quotations for, and transactions in, securities.
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    \28\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
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    According to the Exchange, quotation and last sale information for
the Shares will be available on the facilities of the Consolidated Tape
Association (``CTA''), and the previous day's closing price and trading
volume information for the Shares will be generally available daily in
the print and online financial press. Additionally, information
regarding market price and volume of the Shares will be continually
available on a real-time basis throughout the day on brokers' computer
screens and other electronic services. Daily trading volume information
will be available in the financial section of newspapers, through
subscription services such as Bloomberg, Thomson Reuters, and
International Data Corporation, which can be accessed by authorized
participants and other investors, as well as through other electronic
services, including major public Web sites.
    In addition, for each Fund, the Intraday Indicative Value \29\ will
be updated and widely disseminated by one or more major market data
vendors at least every 15 seconds during the Exchange's Regular Trading
Hours.\30\ On each business day, before commencement of trading in the
Shares during Regular Trading Hours on the Exchange, each Fund will
disclose on its Web site the Disclosed Portfolio \31\ that will form
the basis for the Fund's calculation of NAV at the end of the business
day.\32\ Each Fund's Web site will also include a form of the
prospectus for the Fund that may be downloaded and additional data
relating to NAV and other applicable quantitative information.
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    \29\ According to the Exchange, the Intraday Indicative Value
for each Fund will reflect an estimated intraday value of such
Fund's portfolio, and will be based upon the current value for the
components of the Disclosed Portfolio (as defined below). The
quotations of certain of the Funds' holdings may not be updated for
purposes of calculating Intraday Indicative Value during U.S.
trading hours where the market on which the underlying asset is
traded settles prior to the end of the Exchange's Regular Trading
Hours. The Exchange's Regular Trading Hours are 9:30 a.m. to 4:00
p.m. Eastern Time.
    \30\ The Exchange notes that several major market data vendors
display and/or make widely available Intraday Indicative Values
published via the CTA or other data feeds.
    \31\ The Disclosed Portfolio will include, as applicable: Ticker
symbol or other identifier, a description of the holding, identity
of the asset upon which the derivative is based, the strike price
for any options, the quantity of each security or other asset held
as measured by select metrics, maturity date, coupon rate, effective
date, market value and percentage weight of the holding in the
portfolio. The Web site and information will be publicly available
at no charge.
    \32\ The NAV of each Fund will generally be determined at 4:15
p.m. Eastern Time each business day when the Exchange is open for
trading.
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    Intraday price quotations on cash and cash equivalents, repurchase
agreements, and reverse repurchase agreements of the type held by the
Funds are available from major broker-dealer firms and from third-
parties, which may provide prices free with a time delay, or ``live''
with a paid fee. Price information for investment company securities
(other than exchange-traded investment company securities) will be
available from the applicable investment company's Web site and from
market data vendors. Price information for OTC-traded options will be
available from market data vendors. Major broker-dealer firms will
provide intraday quotes on swaps of the type held by the Funds. Pricing
information related to exchange-listed instruments, including exchange-
listed options, securities of other investment companies, pooled
investment vehicles, and exchange-traded notes, will be available
directly from the listing exchange. Pricing information related to
money market fund shares will be available through issuer Web sites and
publicly available quotation services such as Bloomberg, Markit and
Thomson Reuters. For VIX Futures Contracts, intraday information is
available directly from CBOE. Intraday price information for the
underlying investments of the Funds is also available through
subscription services, such as Bloomberg and Thomson Reuters, which can
be accessed by authorized participants and other investors.
    The Commission further believes that the proposal to list and trade
the Shares is reasonably designed to promote fair disclosure of
information that may be necessary to price the Shares appropriately and
to prevent trading when a reasonable degree of transparency cannot be
assured. The Exchange will obtain a representation from the issuer of
the Shares that the NAV will be calculated daily and that the NAV and
the Disclosed Portfolio will be made available to all market
participants at the same time. Further, trading in the Shares will be
subject to BATS Rules 11.18 and 14.11(i)(4)(B)(iv), which set forth
circumstances under which trading in Shares of a Fund may be halted.
Trading may also be halted because of market conditions or for reasons
that, in the view of the Exchange, make trading in the Shares
inadvisable. These may include: (1) The extent to which trading is not
occurring in the instruments composing the Disclosed Portfolio of a
Fund; or (2) whether other unusual conditions or circumstances
detrimental to the maintenance of a fair and orderly market are
present. The Reporting Authority that provides the Disclosed Portfolio
must implement and maintain, or be subject to, procedures designed to
prevent the use and dissemination of material, non-public information
regarding the actual components of the portfolio.\33\ The Exchange
represents that it prohibits the distribution of material non-public
information by its employees. The Exchange states that neither the
Adviser nor the Sub-Adviser is or is affiliated with a broker-dealer
and that, in the event that (a) the Adviser or Sub-Adviser becomes a
broker-dealer or newly affiliated with a broker-dealer, or (b) any new
adviser or sub-adviser is a broker-dealer or becomes affiliated with a
broker-dealer, it will implement a fire wall with

respect to its relevant personnel or such broker-dealer affiliate, as
applicable, regarding access to information concerning the composition
and/or changes to the portfolio, and will be subject to procedures
designed to prevent the use and dissemination of material non-public
information regarding such portfolio.\34\ Prior to the commencement of
trading, the Exchange will inform its members in an Information
Circular of the special characteristics and risks associated with
trading the Shares. The Exchange may obtain information regarding
trading in the Shares, exchange-listed options, exchange-listed equity
securities, and the underlying futures via the Intermarket Surveillance
Group (``ISG'') from other exchanges who are members or affiliates of
the ISG or with which the Exchange has entered into a comprehensive
surveillance sharing agreement. In addition, the Exchange is able to
access, as needed, trade information for certain fixed income
instruments reported to FINRA's Trade Reporting and Compliance Engine.
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    \33\ See BATS Rule 14.11(i)(4)(B)(ii)(b).
    \34\ The Exchange represents that an investment adviser to an
open-end fund is required to be registered under the Investment
Advisers Act of 1940.
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    The Exchange represents that it deems the Shares to be equity
securities, thus rendering trading in the Shares subject to the
Exchange's existing rules governing the trading of equity securities.
In support of this proposal, the Exchange has made the following
representations:
    (1) The Shares will be subject to BATS Rule 14.11(i), which sets
for the initial and continued listing criteria applicable to Managed
Fund Shares.
    (2) The Exchange has appropriate rules to facilitate transactions
in the Shares during all trading sessions.
    (3) Trading of the Shares through the Exchange will be subject to
the Exchange's surveillance procedures for derivative products,
including Managed Fund Shares, and such surveillance procedures are
adequate to properly monitor the trading of the Shares on the Exchange
during all trading sessions and to deter and detect violations of
Exchange rules and the applicable federal securities laws.
    (4) Prior to the commencement of trading, the Exchange will inform
its members in an Information Circular of the special characteristics
and risks associated with trading the Shares. Specifically, the
Information Circular will discuss the following: (a) The procedures for
purchases and redemptions of Shares in creation units (and that Shares
are not individually redeemable); (b) BATS Rule 3.7, which imposes
suitability obligations on Exchange members with respect to
recommending transactions in the Shares to customers; (c) how
information regarding the Intraday Indicative Value and Disclosed
Portfolio is disseminated; (d) the risks involved in trading the Shares
during the Pre-Opening and After Hours Trading Sessions (as defined in
the Exchange's rules) when an updated Intraday Indicative Value will
not be calculated or publicly disseminated; (e) the requirement that
members deliver a prospectus to investors purchasing newly issued
Shares prior to or concurrently with the confirmation of a transaction;
and (f) trading information.
    (5) For initial and continued listing, each Fund must be in
compliance with Rule 10A-3 under the Act.\35\
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    \35\ See 17 CFR 240.10A-3.
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    (6) All VIX Futures Contracts held by the Funds will be exchange-
traded.
    (7) All of the futures contracts in the Disclosed Portfolio for
each Fund (including futures contracts held by each Subsidiary) will
trade on markets that are a member of ISG or with which the Exchange
has in place a comprehensive surveillance sharing agreement.
    (8) Aside from each Fund's investments in its Subsidiary, neither
the Fund nor its respective Subsidiary will invest in non-U.S. equity
securities or options.
    (9) Although the Funds may invest in inverse investment company
securities, pooled investment vehicles, and ETNs, the Funds will not
invest in leveraged (e.g., 2X, -2X, 3X or -3X) investment company
securities, pooled investment vehicles, or ETNs.
    (10) Each Fund's investments in OTC derivatives will not exceed 20%
of its assets.
    (11) Each Fund may hold up to an aggregate amount of 15% of its net
assets in illiquid assets (calculated at the time of investment) deemed
illiquid by the Adviser under the 1940 Act. Each Fund will monitor its
portfolio liquidity on an ongoing basis to determine whether, in light
of current circumstances, an adequate level of liquidity is being
maintained, and will consider taking appropriate steps in order to
maintain adequate liquidity if, through a change in values, net assets,
or other circumstances, more than 15% of the Fund's net assets are held
in illiquid assets.
    (12) Each Fund's investments will be consistent with the Fund's
investment objective and will not be used to achieve leveraged or
inverse leveraged returns.
    (13) A minimum of 100,000 Shares for each Fund will be outstanding
at the commencement of trading on the Exchange.
    The Exchange represents that all statements and representations
made in the filing regarding (a) the description of the portfolio, (b)
limitations on portfolio holdings or reference assets, or (c) the
applicability of Exchange rules and surveillance procedures constitute
continued listing requirements for listing the Shares on the Exchange.
In addition, the issuer has represented to the Exchange that it will
advise the Exchange of any failure by a Fund to comply with the
continued listing requirements, and, pursuant to its obligations under
Section 19(g)(1) of the Act, the Exchange will surveil for compliance
with the continued listing requirements. If a Fund is not in compliance
with the applicable listing requirements, the Exchange will commence
delisting procedures under Exchange Rule 14.12.
    This approval order is based on all of the Exchange's
representations, including those set forth above and in Amendment No.
5. The Commission notes that the Funds and the Shares must comply with
the requirements of BATS Rule 14.11(i) to be initially and continuously
listed and traded on the Exchange.
    For the foregoing reasons, the Commission finds that the proposed
rule change, as modified by Amendment Nos. 1, 2, and 5, is consistent
with Section 6(b)(5) of the Act \36\ and Section 11A(a)(1)(C)(iii) of
the Act \37\ and the rules and regulations thereunder applicable to a
national securities exchange.
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    \36\ 15 U.S.C. 78f(b)(5).
    \37\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
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IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\38\ that the proposed rule change (SR-BATS-2015-124), as modified
by Amendment Nos. 1, 2, and 5, be, and it hereby is, approved.
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    \38\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\39\
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    \39\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-09062 Filed 4-19-16; 8:45 am]
 BILLING CODE 8011-01-P