[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)]
[Notices]
[Pages 61685-61690]
[FR Doc No: 2016-21351]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0731]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based
Products: Establishment Registration and Listing; Eligibility
Determination for Donors; and Current Good Tissue Practice

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 information collection
requirements for FDA regulations related to human cells, tissues, and
cellular and tissue-based products (HCT/Ps) involving establishment
registration and listing using Form FDA 3356; eligibility determination
for donors; and current good tissue practice (CGTP).

DATES: Submit either written or electronic comments on the collection
of information by November 7, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0731 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Human Cells, Tissues, and
Cellular and Tissue-Based Products: Establishment Registration and
Listing; Eligibility Determination for Donors; and Current Good Tissue
Practice.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 11601 Landsdown
St., 10A-12M, North Bethesda, MD 20852<EMAIL_ADDRESS>
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.

Human Cells, Tissues, and Cellular and Tissue-Based Products:
Establishment Registration and Listing; Eligibility Determination for
Donors; and Current Good Tissue Practice--OMB Control Number 0910-
0543--Extension

    Under section 361 of the Public Health Service Act (the PHS Act)
(42 U.S.C. 264), FDA may issue and enforce regulations necessary to
prevent the introduction, transmission, or spread of communicable
diseases between the States or possessions or from foreign

countries into the States. As derivatives of the human body, all HCT/Ps
pose some risk of carrying pathogens that could potentially infect
recipients or handlers. FDA has issued regulations related to HCT/Ps
involving establishment registration and listing using Form FDA 3356,
eligibility determination for donors, and CGTP.

Establishment Registration and Listing; Form FDA 3356

    The regulations in part 1271 (21 CFR part 1271) require domestic
and foreign establishments that recover, process, store, label,
package, or distribute an HCT/P described in Sec.  1271.10(a), or that
perform screening or testing of the cell or tissue donor to register
with FDA (Sec.  1271.10(b)(1)) and submit a list of each HCT/P
manufactured (Sec.  1271.10(b)(2)). Section 1271.21(a) requires an
establishment to follow certain procedures for initial registration and
listing of HCT/Ps, and Sec.  1271.25(a) and (b) identifies the required
initial registration and HCT/P listing information. Section 1271.21(b),
in brief, requires an annual update of the establishment registration.
Section 1271.21(c)(ii) requires establishments to submit HCT/P listing
updates if a change as described in Sec.  1271.25(c) has occurred.
Section 1271.25(c) identifies the required HCT/P listing update
information. Section 1271.26 requires establishments to submit an
amendment if ownership or location of the establishment changes. FDA
requires the use of a registration and listing form, Form FDA 3356:
Establishment Registration and Listing for Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps), to submit the required
information (Sec. Sec.  1271.10, 1271.21, 1271.25, and 1271.26). To
further facilitate the ease and speed of submissions, electronic
submission is accepted at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/TissueEstablishmentRegistration/default.htm.
    Form FDA 3356 is being revised as follows: (1) Adding import
contact information including an email address and phone number; (2)
deleting columns related to HCT/Ps subject to registration and listing
under 21 CFR part 207 or 807; and (3) revising the instructions
accordingly. The estimated burden is not affected by these changes.

Eligibility Determination for Donors

    In brief, FDA requires certain HCT/P establishments described in
Sec.  1271.1(b) to determine donor eligibility based on donor screening
and testing for relevant communicable disease agents and diseases
except as provided under Sec.  1271.90. The documented determination of
a donor's eligibility is made by a responsible person as defined in
Sec.  1271.3(t) and is based on the results of required donor
screening, which includes a donor medical history interview (defined in
Sec.  1271.3(n)), and testing (Sec.  1271.50(a)). Certain records must
accompany an HCT/P once the donor-eligibility determination has been
made (Sec.  1271.55(a)). This requirement applies both to an HCT/P from
a donor who is determined to be eligible as well as to an HCT/P from a
donor who is determined to be ineligible or where the donor-eligibility
determination is not complete if there is a documented urgent medical
need, as defined in Sec.  1271.3(u) (Sec.  1271.60). Once the donor-
eligibility determination has been made, the HCT/P must be accompanied
by a summary of records used to make the donor eligibility
determination (Sec.  1271.55(b)), and a statement whether, based on the
results of the screening and testing of the donor, the donor is
determined to be eligible or ineligible (Sec.  1271.55(a)(2)). Records
used in determining the eligibility of a donor, i.e., results and
interpretations of testing for relevant communicable disease agents,
the donor-eligibility determination, the name and address of the
testing laboratory or laboratories, and the name of the responsible
person (defined in Sec.  1271.3(t)) who made the donor-eligibility
determination and the date of the determination, must be maintained
(Sec.  1271.55(d)(1)). If any information on the donor is not in
English, the original record must be maintained and translated to
English, and accompanied by a statement of authenticity by the
translator (Sec.  1271.55(d)(2)). HCT/P establishments must retain the
records pertaining to a particular HCT/P at least 10 years after the
date of its administration, or, if the date of administration is not
known, then at least 10 years after the date of the HCT/P's
distribution, disposition, or expiration, whichever is latest (Sec.
1271.55(d)(4)).
    When a product is shipped in quarantine, as defined in Sec.
1271.3(q), before completion of screening and testing, the HCT/P must
be accompanied by records identifying the donor stating that the donor-
eligibility determination has not been completed and stating that the
product must not be implanted, transplanted, infused, or transferred
until completion of the donor-eligibility determination, except in
cases of urgent medical need, as defined in Sec.  1271.3(u) (Sec.
1271.60(c)). When a HCT/P is used in cases of documented urgent medical
need, the results of any completed donor screening and testing, and a
list of any required screening and testing that has not yet been
completed also must accompany the HCT/P (Sec.  1271.60(d)(2)). When a
HCT/P is used in cases of urgent medical need or from a donor who has
been determined to be ineligible (as permitted under Sec.  1271.65),
documentation by the HCT/P establishment is required showing that the
recipient's physician received notification that the testing and
screening were not complete (in cases of urgent medical need), and upon
the completion of the donor-eligibility determination, of the results
of the determination (Sec. Sec.  1271.60(d)(3) and (d)(4), and
1271.65(b)(3)).
    An HCT/P establishment is also required to establish and maintain
procedures for all steps that are performed in determining eligibility
(Sec.  1271.47(a)), including the use of a product from a donor of
viable, leukocyte-rich cells or tissue testing reactive for
cytomegalovirus (Sec.  1271.85(b)(2)). The HCT/P establishment must
record and justify any departure from a procedure relevant to
preventing risks of communicable disease transmission at the time of
its occurrence (Sec.  1271.47(d)).

Current Good Tissue Practice (CGTP)

    FDA requires HCT/P establishments to follow CGTP (Sec.  1271.1(b)).
Section 1271.155(a) permits the submission of a request for FDA
approval of an exemption from or an alternative to any requirement in
subpart C or D of part 1271. Section 1271.290(c) requires
establishments to affix a distinct identification code to each HCT/P
that they manufacture that relates the HCT/P to the donor and to all
records pertaining to the HCT/P. Whenever an establishment distributes
an HCT/P to a consignee, Sec.  1271.290(f) requires the establishment
to inform the consignee, in writing, of the product tracking
requirements and the methods the establishment uses to fulfill these
requirements. Non-reproductive HCT/P establishments described in Sec.
1271.10 are required under Sec.  1271.350(a)(1) and (a)(3) to
investigate and report to FDA adverse reactions (defined in Sec.
1271.3(y)) using Form FDA 3500A (Sec.  1271.350(a)(2)). Form FDA 3500A
is approved under OMB control number 0910-0291. Section 1271.370(b) and
(c) requires establishments to include specific information either on
the HCT/P label or with the HCT/P.

    The standard operating procedures (SOP) provisions under part 1271
include the following: (1) Sec.  1271.160(b)(2) (receiving,
investigation, evaluating, and documenting information relating to core
CGTP requirements, including complaints, and for sharing information
with consignees and other establishments); (2) Sec.  1271.180(a) (to
meet core CGTP requirements for all steps performed in the manufacture
of HCT/Ps); (3) Sec.  1271.190(d)(1) (facility cleaning and
sanitization); (4) Sec.  1271.200(b) (cleaning, sanitizing, and
maintenance of equipment); (5) Sec.  1271.200(c) (calibration of
equipment); (6) Sec.  1271.230(a) and (c) (validation of a process and
review and evaluation of changes to a validated process); (7) Sec.
1271.250(a) (controls for labeling HCT/Ps); (8) Sec.  1271.265(e)
(receipt, predistribution shipment, availability for distribution, and
packaging and shipping of HCT/Ps); (9) Sec.  1271.265(f) (suitable for
return to inventory); (10) Sec.  1271.270(b) (records management
system); (11) Sec.  1271.290(b)(1) (system of HCT/P tracking); and (12)
Sec.  1271.320(a) (review, evaluation, and documentation of complaints
as defined in Sec.  1271.3(aa)).
    Section 1271.155(f) requires an establishment operating under the
terms of an exemption or alternative to maintain documentation of FDA's
grant of the exemption or approval and the date on which it began
operating under the terms of the exemption or alternative. Section
1271.160(b)(3) requires the quality program of an establishment that
performs any step in the manufacture of HCT/Ps to document corrective
actions relating to core CGTP requirements. Section 1271.160(b)(6)
requires documentation of HCT/P deviations. Section 1271.160(d)
requires, in brief, documentation of validation of computer software if
the establishment relies upon it to comply with core CGTP requirements.
Section 1271.190(d)(2) requires documentation of all cleaning and
sanitation activities performed to prevent contamination of HCT/Ps.
Section 1271.195(d) requires documentation of environmental control and
monitoring activities. Section 1271.200(e) requires documentation of
all equipment maintenance, cleaning, sanitizing, calibration, and other
activities. Section 1271.210(d) requires, in brief, documentation of
the receipt, verification, and use of each supply or reagent. Section
1271.230(a) requires documentation of validation activities and results
when the results of processing described in Sec.  1271.220 cannot be
fully verified by subsequent inspection and tests. Section 1271.230(c)
requires that when changes to a validated process subject to Sec.
1271.230(a) occur, documentation of the review and evaluation of the
process and revalidation, if necessary, must occur. Section 1271.260(d)
and (e) requires documentation of any corrective action taken when
proper storage conditions are not met and documentation of the storage
temperature for HCT/Ps. Section 1271.265(c)(1) requires documentation
that all release criteria have been met before distribution of an HCT/
P. Section 1271.265(c)(3) requires documentation of any departure from
a procedure relevant to preventing risks of communicable disease
transmission at the time of occurrence. Section 1271.265(e) requires
documentation of the activities in paragraphs (a) through (d) of this
section, which must include identification of the HCT/P and the
establishment that supplied the HCT/P, activities performed and the
results of each activity, date(s) of activity, quantity of HCT/P
subject to the activity, and disposition of the HCT/P. Section
1271.270(a) requires documentation of each step in manufacturing
required in part 1271, subparts C and D. Section 1271.270(e) requires
documentation of the name and address, and a list of responsibilities
of any establishment that performs a manufacturing step for the
establishment. Section 1271.290(d) and (e) require documentation of a
method for recording the distinct identification code and type of each
HCT/P distributed to a consignee to enable tracking from the consignee
to the donor and to enable tracking from the donor to the consignee or
final disposition. Section 1271.320(b) requires an establishment to
maintain a record of each complaint that it receives. The complaint
file must contain sufficient information about each complaint for
proper review and evaluation of the complaint and for determining
whether the complaint is an isolated event or represents a trend.
    Respondents to this information collection are establishments that
recover, process, store, label, package, or distribute any HCT/P, or
perform donor screening or testing. The estimates provided below are
based on most recent available information from FDA's database system
and trade organizations. The hours per response and hours per record
are based on data provided by the Eastern Research Group, or FDA
experience with similar recordkeeping or reporting requirements.
    There are an estimated 2,218 HCT/P establishments (conventional
tissue, eye tissue, peripheral blood stem cell, stem cell products from
cord blood, reproductive tissue, and sperm banks), including 667
manufacturers of HCT/P products regulated under the Federal Food, Drug,
and Cosmetic Act and section 351 of the PHS Act (42 U.S.C. 262), that
have registered and listed with FDA. In addition, we estimate that 182
new establishments have registered with FDA (Sec. Sec.  1271.10(b)(1)
and (b)(2) and 1271.25(a) and (b)). There are an estimated 1,221
listing updates (Sec. Sec.  1271.10(b)(2), 1271.21(c)(ii), and
1271.25(c)) and 588 location/ownership amendments (Sec.  1271.26).
    Under Sec.  1271.55(a), an estimated total of 2,206,890 HCT/Ps
(which include conventional tissues, eye tissues, hematopoetic stem
cells/progenitor cells, and reproductive cells and tissues), and an
estimated total of 2,066,890 non-reproductive cells and tissues (total
HCT/Ps minus reproductive cells and tissues) are distributed per year
by an estimated 1,551 establishments (2,218-667 = 1,551) with approved
applications).
    Under Sec.  1271.60(c) and (d)(2), FDA estimates that 1,375
establishments shipped an estimated 572,000 HCT/P under quarantine, and
that an estimated 25 establishments requested 78 exemptions from or
alternative to any requirement under part 1271, subpart C or D,
specifically under Sec.  1271.155(a).
    Under Sec. Sec.  1271.290(c) and 1271.370(b) and (c), the estimated
1,561 non-reproductive HCT/P establishments label each of their
2,066,890 HCT/Ps with certain information. These establishments are
also required to inform their consignees in writing of the requirements
for tracking and of their established tracking system under Sec.
1271.290(f).
    FDA estimates 34 HCT/P establishments submitted 166 adverse
reaction reports with 136 involving a communicable disease (Sec.
1271.350(a)(1)).
    FDA estimates that 182 new establishments will create SOPs, and
that 2,218 establishments will review and revise existing SOPs
annually.
    FDA estimates that 1,109 HCT/P establishments (2,218 x 50 percent =
1,109) and 781 non-reproductive HCT/P establishments (1,561 x 50
percent = 781) record and justify a departure from the procedures
(Sec. Sec.  1271.47(d) and 1271.265(c)(3)).
    Under Sec.  1271.50(a), HCT/P establishments are required to have a
documented medical history interview about the donor's medical history
and relevant social behavior as part of the

donor's relevant medical records for each of the estimated total of
109,019 donors (which include conventional tissue donors, eye tissue
donors, peripheral and cord blood stem cell donors, and reproductive
cell and tissue donors), and the estimated total of 103,419 non-
reproductive cells and tissue donors (total donors minus reproductive
cell and tissue donors).
    FDA estimates that 665 HCT/P establishments (2,218 x 30 percent =
665) document an urgent medical need of the product to notify the
physician using the HCT/P (Sec. Sec.  1271.60(d)(3) and 1271.65(b)(3)).
    FDA also estimates that 1,774 HCT/P establishments (2,218 x 80
percent = 1,774) have to maintain records for an average of 2 contract
establishments to perform their manufacturing process (Sec.
1271.270(e), and 1,249 HCT/P establishments (1,561 x 80 percent =
1,249) maintain an average of 5 complaint records annually (Sec.
1271.320(b)).
    In some cases, the estimated burden may appear to be lower or
higher than the burden experienced by individual establishments. The
estimated burden in these charts is an estimated average burden, taking
into account the range of impact each regulation may have.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
               21 CFR Section                    Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses                                                      \3\
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1271.10(b)(1) and 1271.21(b) \2\............           2,218               1           2,218  .5 (30 minutes)...........................           1,109
1271.10(b)(1) and (b)(2), 1271.21(a), and                182               1             182  .75 (45 minutes)..........................             137
 1271.25(a) and (b) \2\
1271.10(b)(2), 1271.21(c)(2)(ii) and                   1,221               1           1,221  .5 (30 minutes)...........................             611
 1271.25(c) \2\.
1271.26 \2\.................................             588               1             588  .25 (15 minutes)..........................             147
1271.155(a).................................              25            3.12              78  3.........................................             234
1271.350(a)(1) and (a)(3)...................              34            4.88             166  1.........................................             166
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................           2,404
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Using Form FDA 3356.
\3\ Rounded to the nearest whole number.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                 Number of
               21 CFR Section                    Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                                              record-keepers   recordkeeper       records                                                       \3\
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New SOPs \2\................................             182               1             182  48........................................           8,736
SOP Update \2\..............................           2,218               1           2,218  24........................................          53,232
1271.47(d)..................................           1,109               1           1,109  1.........................................           1,109
1271.50(a)..................................           2,218           49.15         109,019  5.........................................         545,095
1271.55(d)(1)...............................           2,218           49.15         109,019  1.........................................         109,019
1271.55(d)(2)...............................           2,218               1           2,218  1.........................................           2,218
1271.55(d)(4)...............................           2,218               1           2,218  120.......................................         266,160
1271.60(d)(3) and (d)(4) 1271.65(b)(3)(iii).             665               1             665  2.........................................           1,330
1271.155(f).................................              25            3.12              78  .25 (15 minutes)..........................              20
1271.160(b)(3) and (b)(6)...................           1,561              12          18,732  1.........................................          18,732
1271.160(d).................................           1,561              12          18,732  1.........................................          18,732
1271.190(d)(2)..............................           1,561              12          18,732  1.........................................          18,732
1271.195(d).................................           1,561              12          18,732  1.........................................          18,732
1271.200(e).................................           1,561              12          18,732  1.........................................          18,732
1271.210(d).................................           1,561              12          18,732  1.........................................          18,732
1271.230(a).................................           1,561              12          18,732  1.........................................          18,732
1271.230(c).................................           1,561               1           1,561  1.........................................           1,561
1271.260(d).................................           1,561              12          18,732  .25 (15 minutes)..........................           4,683
1271.260(e).................................           1,561             365         569,765  .083 (5 minutes)..........................          47,291
1271.265(c)(1)..............................           1,561        1,324.08       2,066,890  .083 (5 minutes)..........................         171,552
1271.265(c)(3)..............................             781               1             781  1.........................................             781
1271.265(e).................................           1,561        1,324.08       2,066,890  .083 (5 minutes)..........................         171,552
1271.270(a).................................           1,561        1,324.08       2,066,890  .25 (15 minutes)..........................         516,723
1271.270(e).................................           1,774               2           3,548  .5 (30 minutes)...........................           1,774
1271.290(d) and (e).........................           1,561           66.25         103,419  .25 (15 minutes)..........................          25,855
1271.320(b).................................           1,249               5           6,245  1.........................................           6,245
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................       2,066,060
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Sections 1271.47(a), 1271.85(b)(2), 1271.160(b)(2) and (d)(1), 1271.180(a), 1271.190(d)(1), 1271.200(b), 1271.200(c), 1271.230(a), 1271.250(a), and
  1271.265(e).
\3\ Rounded to the nearest whole number.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                                                 Number of      disclosures    Total annual
               21 CFR Section                   respondents         per         disclosures          Average burden per disclosure          Total hours
                                                                respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.55(a)..................................           1,551        1,422.88       2,206,890  .5 (30 minutes)...........................       1,103,445
1271.60(c) and (d)(2).......................           1,375             416         572,000  .5 (30 minutes)...........................         286,000
1271.290(c).................................           1,561        1,324.08       2,066,890  .083 (5 minutes)..........................         171,552
1271.290(f).................................           1,561               1           1,561  1.........................................           1,561
1271.370(b) and (c).........................           1,561        1,324.08       2,066,890  .25 (15 minutes)..........................         516,723
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................       2,079,281
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: August 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21351 Filed 9-6-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Notices]
[Page 49221]
[FR Doc No: 2015-20201]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER15-2243-000]

Silver State Solar Power South, LLC; Supplemental Notice That
Initial Market-Based Rate Filing Includes Request for Blanket Section
204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Silver State Solar Power South, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is August 31, 2015.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

     Dated: August 11, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-20201 Filed 8-14-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Notices]
[Page 12982]
[FR Doc No: 2011-5412]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2011-0104]

Policy for Guidelines for Coast Guard Evaluations of Compliance
With the U.S. Environmental Protection Agency's Vessel General Permit
for Discharges Incidental to the Normal Operation of Vessels

AGENCY: Coast Guard, DHS.

ACTION: Notice of availability.

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SUMMARY: The Coast Guard announces the release of policy letter 11-01,
Policy for Guidelines for Coast Guard Evaluations of Compliance with
the U.S. Environmental Protection Agency's (EPA) Vessel General Permit
(VGP) for Discharges Incidental to the Normal Operation of Vessels.
This policy letter provides guidance to assist Coast Guard personnel to
evaluate compliance with the provisions of the EPA's VGP, for U.S. and
foreign-flagged vessels subject to the VGP and operating in the waters
of the United States.

DATES: This policy became effective on February 11, 2011.

ADDRESSES: This notice and the policy are available in the docket and
can be viewed by going to http://www.regulations.gov, inserting USCG-
2011-0104 in the ``Keyword'' box, and then clicking ``Search.'' This
policy is also available at http://www.homeport.uscg.mil under the Port
State Control tab; Foreign Vessel Safety; Policy for Guidelines for
Coast Guard Evaluations of Compliance with the U.S. Environmental
Protection Agency's (EPA) Vessel General Permit for Discharges
Incidental to the Normal Operation of Vessels. They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice
or the policy, call or e-mail Mr. John S. Sedlak, P.E., Foreign and
Offshore Vessels Division (CG-5432), U.S. Coast Guard, telephone 202-
372-1240. If you have questions on viewing or submitting material to
the docket, call Ms. Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background and Purpose

    The VGP is an EPA permitting program issued under the Clean Water
Act (33 U.S.C. 1342) and provides requirements for discharges
incidental to the normal operation of vessels. Under the Clean Water
Act, discharges of pollutants from vessels that are not covered by the
VGP are unlawful unless they are exempt or covered by another Clean
Water Act permit. The Coast Guard shares a mutual interest in ensuring
vessels comply with VGP provisions. In fulfilling its role as the
nation's lead maritime law enforcement agency and to carry out its
mission of environmental stewardship, it is in the interest of the
Coast Guard to assist the EPA in the detection and reporting of VGP
deficiencies onboard vessels during regularly scheduled inspections of
U.S. vessels and during Port State Control (PSC) exams on foreign
vessels. The Coast Guard will report detected VGP deficiencies to the
EPA.
    The Coast Guard has prepared policy letter 11-01, Policy for
Guidelines for Coast Guard Evaluations of Compliance with the U.S.
Environmental Protection Agency's Vessel General Permit for Discharges
Incidental to the Normal Operation of Vessels, in consultation with the
EPA to assist Coast Guard staff in the preparation for and the
execution of VGP compliance monitoring inspections and exams. Vessel
owners and/or operators are ultimately responsible for compliance with
all aspects of the VGP. Vessels may be subject to inspection to verify
compliance with any and all legal requirements. Vessel owners and
operators may wish to take note of the minimum items that the Marine
Inspectors (MI) and PSC Officers may examine during VGP compliance
exams, as outlined in the policy letter. Vessel owners and operators
should note further that MI/PSC Officers are not limited in the depth
and scope of the examination.

Policy Implementation

    The Coast Guard will evaluate vessels for compliance with the
Vessel General Permit beginning on March 13, 2011.

    Authority: This notice is issued under authority of 5 U.S.C.
552(a), 33 U.S.C. 1223, 14 U.S.C. 93(a)(20), and 14 U.S.C. 141.

    Dated: March 3, 2011.
Kevin S. Cook,
Rear Admiral, U.S. Coast Guard, Director of Prevention Policy.
[FR Doc. 2011-5412 Filed 3-8-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: September 15, 2008 (Volume 73, Number 179)]
[Notices]
[Page 53297]
[DOCID:fr15se08-120]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon written request, copies available from: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension: Rule 17Ad-3(b), SEC File No. 270-424, OMB Control No.
3235-0473.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget a request for approval of extension of the following
previously approved collection of information as discussed below.
     Rule 17Ad-3(b) (17 CFR 240.17Ad-3(b)).
    Rule 17Ad-3(b) requires registered transfer agents that for each of
two consecutive months have failed to turnaround at least 75% of all
routine items in accordance with the requirements of Rule 17Ad-2(a) or
to process at least 75% of all routine items in accordance with the
requirements of Rule 17Ad-2(a) to send to the chief executive officer
of each issuer for which such registered transfer agent acts a copy of
the written notice required under Rule 17Ad-2(c), (d), and (h). The
issuer may use the information contained in the notices in several
ways: (1) to provide an early warning to the issuer of the transfer
agent's non-compliance with the Commission's minimum performance
standards regarding registered transfer agents, and (2) to assure that
issuers are aware of certain problems and poor performances with
respect to the transfer agents that are servicing the issuer's
securities. If the issuer does not receive notice of a registered
transfer agent's failure to comply with the Commission's minimum
performance standards then the issuer will be unable to take remedial
action to correct the problem or to find another registered transfer
agent. Pursuant to Rule 17Ad-3(b), a transfer agent that has already
filed a Notice of Non-Compliance with the Commission pursuant to Rule
17Ad-2 will only be required to send a copy of that notice to issuers
for which it acts when that transfer agent fails to turnaround 75% of
all routine items or to process 75% of all items.
    The Commission estimates that only two transfer agents will meet
the requirements of Rule 17Ad-3(b). If a transfer agent fails to meet
the minimum requirements under 17Ad-3(b), such transfer agent is simply
sending a copy of a form that had already been produced for the
Commission. The Commission estimates a requirement will take each
respondent approximately one hour to complete, for a total annual
estimate burden of two hours at cost of approximately $60.00 for each
hour. Please note that 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 control number.
    General comments regarding the estimated burden hours should be
directed to: (i) Desk Officer for the Securities and Exchange
Commission, Office of Information and Regulatory Affairs, Office of
Management and Budget, Room 10102, New Executive Office Building,
Washington, DC 20503 or by sending an e-mail to: Kimberly_P._
<EMAIL_ADDRESS>and (ii) Lewis W. Walker, Acting Director/Chief
Information Officer, Securities and Exchange Commission, C/O Shirley
Martinson, 6432 General Green Way, Alexandria, Virginia 22312; or by
sending an e-mail to<EMAIL_ADDRESS>Comments must be submitted
to OMB within 30 days of this notice.

    Dated: September 8, 2008.
Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-21407 Filed 9-12-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: January 4, 2008 (Volume 73, Number 3)]
[Notices]
[Page 897-898]
[DOCID:fr04ja08-54]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57057; File No. SR-Amex-2007-94]

Self-Regulatory Organizations; American Stock Exchange, LLC;
Order Granting Accelerated Approval of a Proposed Rule Change, as
Modified by Amendment No. 1 Thereto, Relating to Notes Linked to the
Performance of the CBOE S&P 500 PutWrite Index (PUTSM)

December 28, 2007.

I. Introduction

    On August 20, 2007, the American Stock Exchange, LLC (``Amex'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') a proposed rule change pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder \2\ to list and trade notes, the performance of which is
linked to the CBOE S&P 500 PutWrite Index (PUTSM) (the ``PUT Index'' or
``Index''). On November 27, 2007, the Amex submitted Amendment No. 1 to
the proposed rule change. The proposed rule change, as amended, was
published for comment in the Federal Register on December 6, 2007 for a
15-day comment period.\3\ This order approves the proposed rule change,
as amended on an accelerated basis.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 56853 (November 28,
2007), 72 FR 68914 (``Notice'').
---------------------------------------------------------------------------

II. Description of the Proposal

    The Amex proposes to list for trading under Section 107A of the
Amex Company Guide (``Company Guide'') notes linked to the performance
of the PUT Index (the ``Notes''). The Notes are a series of medium-term
debt securities of Eksportfinans \4\ that provide for a cash payment at
maturity or upon earlier exchange at the holder's option, based on the
performance of the PUT Index as adjusted by an annual index fee (the
``Index Fee''). As described in the Exchange's proposal,\5\ the Notes
are cash-settled in U.S. dollars and do not give the holder any right
to receive any of the component securities, dividend payments, or any
other ownership right or interest in the securities comprising the PUT
Index. The Notes are designed for investors who desire exposure to a
covered put selling options strategy on a broad market index and who
are willing to forego principal protection and market interest payments
on the Notes during their term.
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    \4\ Eksportfinans and Standard & Poor's (``S&P''), a division of
the McGraw-Hill Companies, Inc. have entered into a non-exclusive
license agreement providing for the use of the PUT Index by
Eksportfinans in connection with certain securities including the
Notes. S&P is not responsible for and will not participate in the
issuance and creation of the Notes. Eksportfinans will issue the
Notes under the name ``Eksportfinans Index-Linked Notes.
Eksportfinans has also been appointed to act as the calculation
agent.
    \5\ For a more detailed description of the Notes, including
their structure, applicable exchange listing and trading rules,
disclosure of pricing information, surveillance, and other
regulation, see Notice at 68914-15.
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    The PUT Index is determined, calculated and maintained solely by
the Chicago Board Options Exchange, Inc. (``CBOE'').\6\ The PUT Index
is a benchmark index designed to measure the performance of a
hypothetical investment strategy that overlays short S&P 500 puts over
a money market account. The PUT Index tracks the value of an initial
investment of $100 in a portfolio that passively follows the CBOE S&P
500 PUT strategy. The PUT Index strategy invests cash at one- and
three-month Treasury Bill rates and sells a sequence of one-month at-
the-money S&P 500 puts (SPX). The short put position is collateralized
by the Treasury bills. The theory of the PUT strategy is to trade a
premium over Treasury bill rates for a leveraged exposure to S&P 500
downturns.
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    \6\ For a more detailed description of the Put Index, including
its construction and calculation, see Notice at 68915-17.
---------------------------------------------------------------------------

    The Exchange submits that Section 107A and the continued listing
guidelines under Sections 1001-1003 of the Company Guide will
accommodate the listing and trading of Notes.\7\
---------------------------------------------------------------------------

    \7\ Under Section 107A of the Company Guide, the Exchange may
approve for listing and trading securities which cannot be readily
categorized under the listing criteria for common and preferred
stocks, bonds, debentures, or warrants. See Securities Exchange Act
Release No. 27753 (March 1, 1990), 55 FR 8626 (March 8, 1990) (SR-
Amex-89-29).
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III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities exchange.\8\
The Commission finds that this proposal is similar to several approved
instruments currently listed and traded on the Amex.\9\ Accordingly,
the Commission finds that the proposed rule change is consistent with
Section 6(b)(5) of the Act,\10\ which requires that the rules of an
exchange be designed, among other things, 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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    \8\ In approving this proposed rule change, the Commission notes
that it has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \9\ See Securities Exchange Act Release Nos. 51426 (March 23,
2005), 70 FR 16315 (March 30, 2005) (approving the listing and
trading of Morgan Stanley notes linked to the BXM Index); 50719
(November 22, 2004), 69 FR 69644 (November 30, 2004) (approving the
listing and trading of Morgan Stanley notes linked to the BXM
Index); 51634 (April 29, 2005), 70 FR 24138 (May 6, 2005) (approving
the listing and trading of Wachovia notes linked to the BXM Index);
and 51840 (June 14, 2005), 70 FR 35468 (June 20, 2005) (approving
the listing and trading of JPMorgan notes linked to the BXD Index).
The BXM index is the CBOE S&P 500 BuyWrite IndexSM while the BXD is
the equivalent index using the DJIA as the underlying index rather
than the S&P 500.
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission further believes that the proposal is consistent
with Section 11A(a)(1)(C)(iii) of the Act,\11\ which sets forth
Congress' 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. The requirements of Section 107A of the Company Guide were
designed to address the concerns attendant to the trading of hybrid
securities, such as the Notes. For example, Section 107A of the Company
Guide provides that only issuers satisfying specified asset and equity
requirements may issue securities such as the Notes. In addition, the
Exchange's ``Other Securities'' listing standards further require that
the Notes have a market value of at least $4 million.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78k-1(a)(1)(C)(iii).

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

    Furthermore, the Commission 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 Notes appropriately. As
described in the Notice, the Exchange represents that the PUT Index
value will be calculated and disseminated by the CBOE once every
scheduled trading day after the close. Eksportfinans has agreed to seek
to arrange to have the PUT Index calculated and disseminated on a daily
basis through a third party if the CBOE ceases to calculate and
disseminate the Index. In such an event, the Exchange agrees to obtain
Commission approval, pursuant to filing the appropriate Form 19b-4,
prior to the substitution of the PUT Index. Further, the Exchange has
agreed to undertake to delist the Notes in the event that the CBOE
discontinues calculating and disseminating the Index, and Eksportfinans
is unable to arrange the calculation and dissemination of the PUT
Index.\12\
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    \12\ See Notice at 68917.
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    The daily closing price of the PUT Index is calculated and
disseminated by the CBOE on its Web site at http://www.cboe.com and via

the Options Pricing and Reporting Authority at the end of each trading
day.\13\ The value of the S&P 500 Index is disseminated at least once
every fifteen (15) seconds throughout the scheduled trading day. In
addition, as indicated above, the value of the PUT Index is calculated
once every scheduled trading day, thereby providing investors with a
daily value of such ``hypothetical'' put selling options strategy on
the S&P 500. In addition, the Exchange represents that it will
disseminate over the Consolidated Tape Association's Network B, a daily
indicative Redemption Amount (the ``Indicative Value'') to provide
investors with a daily reference value of the Index. The Indicative
Value, which is not adjusted on an intra-day basis, will be calculated
by the Exchange after the close of trading and after the CBOE
calculates the PUT Index for use by investors the next scheduled
trading day.
---------------------------------------------------------------------------

    \13\ The Commission, in connection with BXM and BXD Index Notes,
approved the listing and trading of these products where the
dissemination of the value of the underlying index occurred once per
trading day. See supra note 9.
---------------------------------------------------------------------------

    Because the PUT Index is not calculated and disseminated every 15
seconds, the Exchange seeks a limited exception from the generic
continued listing requirement set forth in Section 107D(h) of the
Company Guide. In current Commentary .01 to Section 107, the Exchange
provides that although the BXM and BXD Indexes do not satisfy the
requirements of Section 107D(h), these Indexes nevertheless may be
listed and traded pursuant to the generic standards set forth in
Section 107D. The Commission believes that the dissemination of the S&P
500 along with the ability of investors to obtain put option pricing
information provides sufficient transparency regarding the Index. Given
the large trading volume and capitalization of the compositions of the
stocks underlying the S&P 500, the Commission believes that the listing
and trading of the Notes that are linked to the PUT Index should not
unduly impact the market for the underlying securities comprising the
S&P 500 or raise manipulative concerns. Moreover, the issuers of the
underlying securities comprising the S&P 500 are subject to reporting
requirements under the Act, and all of the component stocks are either
listed or traded on, or traded through the facilities of, U.S.
securities markets. Accordingly, the Commissions will allow this
proposed change to Commentary .01 to Section 107 as a limited
exception.
    The Commission also believes that the Exchange's trading halt rules
are reasonably designed to prevent trading in the Notes when
transparency is impaired. The Exchange will halt trading in the Notes
if the circuit breaker parameters of Amex Rule 117 have been
reached.\14\ In exercising its discretion to halt or suspend trading in
the Notes, the Exchange may consider factors such as those set forth in
Amex Rule 918C(b) and other relevant factors.\15\ The Commission
further believes that the trading rules and procedures to which the
Notes will be subject pursuant to this proposal are consistent with the
Act. The Exchange has represented that the Notes are subject to Amex's
rules governing the trading of equity securities.
---------------------------------------------------------------------------

    \14\ E-mail from Andrea Williams, Assistant General Counsel,
Amex and Ronesha Butler, Special Counsel, Division of Trading and
Markets, Commission (``Division''), Commission, on December 28,
2007.
    \15\ Id.
---------------------------------------------------------------------------

    In support of this proposal, the Exchange has made the following
representations:
    (1) The Exchange's surveillance procedures are adequate to properly
monitor the trading of the Notes. Specifically, Amex will rely on its
existing surveillance procedures governing equities and options.
Moreover, the Exchange has a general policy which prohibits the
distribution of material, non-public information by its employees.
    (2) Prior to trading the Notes, the Exchange will distribute a
circular to the membership providing guidance with regard to member
firm compliance responsibilities (including suitability
recommendations) when handling transactions in the Notes and
highlighting the special risks and characteristics of the Notes. With
respect to suitability recommendations and risks, the Exchange will
require members, member organizations and employees thereof
recommending a transaction in the Notes: (1) To determine that such
transaction is suitable for the customer; and (2) to have a reasonable
basis for believing that the customer can evaluate the special
characteristics of, and is able to bear the financial risks of such
transaction. In addition, Eksportfinans will deliver a prospectus in
connection with the initial sales of the Notes.
    This approval order is based on the Exchange's representations.
    The Commission finds good cause, pursuant to Section 19(b)(2) of
the Act,\16\ for approving the proposed rule change, as modified by
Amendment No. 1, prior to the 30th day after the date of publication of
notice in the Federal Register. The Commission notes that the present
proposal is similar to prior proposals that the Commission has
approved.\17\ The Commission does not believe that the proposed rule
change, as modified by Amendment No. 1, raises any novel regulatory
issues. Consequently, the Commission believes that it is appropriate to
permit investors to benefit from these additional investment choices
without delay. Accordingly, the Commission finds that there is good
cause, consistent with Section 6(b)(5) of the Act,\18\ to approve the
proposal, as modified by Amendment No. 1, on an accelerated basis.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(2).
    \17\ See, supra, note 9.
    \18\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\19\ that the proposed rule change (SR-Amex-2007-94), as modified
by Amendment No. 1, be, and it hereby is, approved on an accelerated
basis.
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    \19\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
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    \20\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
[FR Doc. E7-25622 Filed 1-3-08; 8:45 am]

BILLING CODE 8011-01-P


1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON DC 20460 Office of Prevention, Pesticides and Toxic Substances May 25, 2001 MEMORANDUM SUBJECT: RFA/ SBREFA Certification for Import Tolerance Revocation FROM: Denise Keehner, Division Director, Biological and Economic Analysis Division (7503C), Office of Pesticide Programs, OPPTS, U. S. Environmental Protection Agency TO: Public Docket concerning Tolerance Revocation Rulemaking, Proposed or Final Issue: Because tolerance revocation is rule making, the Agency needs to certify  under RFA/ SBREFA  that the tolerance revocation does not impose a significant adverse impact on a substantial number of small entities or conduct an initial and final regulatory flexibility analysis and convene a review panel. Currently, OPP is trying to update the FR notice from 1997 that made a broad, general certification. The same conditions apply now as they did in 1997, but the supporting documentation is being updated, so it is necessary to reconstruct the basis for Agency expectations that import tolerance revocations will not generate significant impacts on substantial numbers of small entities. The primary RFA/ SBREFA focus is on U. S. based import businesses who trade in products that may contain one or more residues being banned under the tolerance revocation.

Preliminary Analysis: The arguments for why we would not expect to see significant impacts on a substantial number of small entities can be put into three different categories:

1. Cases where substantial numbers of small entities are not affected because: a. Import companies are not small businesses. b. If import companies are small businesses, then too few are affected to be ineligible for SBREFA certification.

2. Cases where impact on import commodity price is not significant (minimal supply effects) because: a. Affected commodity is widely traded on international markets/ exchanges, and only a small proportion of overall production is treated. b. A small proportion of a crop is treated within a country, suggested the supply within that country will be relatively unaffected. c. There are sufficient alternatives for the chemical with the cancelled tolerance, and these alternatives have few, if any, impacts on output or production costs for the raw agricultural commodity. 3. Cases where there are limited alternatives for the pesticide in a given country, leading 2 to an increase in the supply price, but: a. The supply price is only a proportion of the import price, where the majority of the price reflects transportation and other distribution costs. b. The supply price increases for a particular commodity from a particular country, but it does not impose a significant impact on importer sales because the import company has diversified sales. c. The supply price increases for a particular commodity from a particular country, but there are other sources of the commodity, and the transaction costs of utilizing other suppliers is sufficiently low that it doesn't significantly affect the overall sales of the importing company.

Therefore, if ANY of these eight conditions hold, then we can certify that there is no SBREFA issue. Conversely, in order for there to be consideration of a SBREFA concern that would require more detailed analysis, ALL of the following have to hold: 1. There are importers for a particular commodity affected by the tolerance revocation, who qualify as small business under SBA guidelines; AND 2. there is a substantial number of small importers whose sales are affected by the tolerance revocation; AND 3. the affected commodity is NOT widely traded on international markets; AND 4. a sizable proportion of the production in the limited geographic production region is treated with the particular pesticide (suggesting potential supply effects); AND 5. there a limited and/ or expensive alternatives for the particular pesticide in the limited geographic production region, with a concomitant potential for sizable yield loss or increase in cost of production; AND 6. the price of the raw agricultural commodity is a large component of the sales price of the import; AND 7. the importing companies are not diversified, and the increase in raw commodity cost will lead to a significant decline in sales revenue.

There is a negligible joint probability of all these conditions holding simultaneously, so I believe it appropriate for the Agency to take the position that import tolerance revocations can be certified under RFA/ SBREFA. I base this conclusion on several observations: most commodities subject to import tolerance revocation are widely traded on international markets (according to USDA's data on agricultural imports and exports) and BEAD's data on foreign pesticide use suggest it is rare for a single pesticide to be extensively used in each production/ export region, such that there is a minimal chance of import tolerance revocation leading to price/ cost increases for importers with an attendant SBREFA concern. Even in the very unlikely event that an import tolerance revocation leads to significant price/ cost increases for a particular commodity, many importers of agricultural commodities are diversified companies dealing in many commodities, so that a price/ cost increase for one commodity will not significantly affect total company revenues.

At the same time, it will be useful to continue building a set of data describing why one or more of these seven conditions is not likely to hold. The plan for the medium to long term is to collect such supporting data, sometimes using general industry profiles and sometimes using analyses of specific commodity/ chemical combinations.


[Federal Register Volume 82, Number 156 (Tuesday, August 15, 2017)]
[Notices]
[Pages 38749-38752]
[FR Doc No: 2017-17169]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81361; File No. SR-NASDAQ-2017-080]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend the Exchange's Transaction Fees

August 9, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on August 1, 2017, The NASDAQ Stock Market LLC (``Nasdaq'' 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. The

Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend the Exchange's transaction fees at
Chapter XV, Section 2 entitled ``NASDAQ Options Market--Fees and
Rebates,'' which governs pricing for Nasdaq Participants using the
NASDAQ Options Market (``NOM''), Nasdaq's facility for executing and
routing standardized equity and index options.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaq.cchwallstreet.com, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes two NOM pricing amendments at Chapter XV,
Section 2(1), as described below in greater detail.
Customer and Professional Rebate to Add Liquidity
    The Exchange proposes to amend an existing method for earning a
rebate for adding liquidity for both Customers \3\ and Professionals
\4\ in Penny Pilot \5\ and Non-Penny Pilot Options. For Customers and
Professionals transacting in Penny Pilot Options, the Exchange
currently pays a volume-based tiered Rebate to Add Liquidity, as set
forth in Chapter XV, Section 2(1) of NOM Rules. That rebate consists of
8 tiers, ranging from $0.20 per contract to $0.48 per contract, with
the volume requirements increasing with each tier. Thus, a NOM
Participant would qualify for a rebate of $0.20 per contract in Tier 1
for Customers and Professionals if it added Customer, Professional,
Firm,\6\ Non-NOM Market Maker \7\ and/or Broker-Dealer \8\ liquidity in
Penny Pilot Options and/or Non-Penny Pilot Options of up to 0.10% of
total industry customer equity and ETF option average daily volume
(``ADV'') contracts per day in a month. In comparison, a Participant
would qualify for a rebate of $0.48 in Tier 8 for Customers and
Professionals if it added Customer, Professional, Firm, Non-NOM Market
Maker and/or Broker-Dealer liquidity in Penny Pilot Options and/or Non-
Penny Pilot Options above 0.75% or more of total industry customer
equity and ETF option ADV contracts per day in a month, or if the
Participant adds: (1) Customer and/or Professional liquidity in Penny
Pilot Options and/or Non-Penny Pilot Options of 0.20% or more of total
industry customer equity and ETF option ADV contracts per day in a
month, and (2) has added liquidity in all securities through one or
more of its Nasdaq Market Center MPIDs that represent 1.00% or more of
Consolidated Volume in a month or qualifies for MARS.\9\
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    \3\ The term ``Customer'' or (``C'') applies to any transaction
that is identified by a Participant for clearing in the Customer
range at The Options Clearing Corporation (``OCC'') which is not for
the account of broker or dealer or for the account of a
``Professional'' (as that term is defined in Chapter I, Section
1(a)(48)).
    \4\ The term ``Professional'' or (``P'') means any person or
entity that (i) is not a broker or dealer in securities, and (ii)
places more than 390 orders in listed options per day on average
during a calendar month for its own beneficial account(s) pursuant
to Chapter I, Section 1(a)(48). All Professional orders shall be
appropriately marked by Participants.
    \5\ The Penny Pilot was established in March 2008. See
Securities Exchange Act Release No. 57579 (March 28, 2008), 73 FR
18587 (April 4, 2008) (SR-NASDAQ-2008-026) (notice of filing and
immediate effectiveness establishing Penny Pilot). Since that date,
the Penny Pilot has been expanded and is currently extended through
December 31, 2016 or the date of permanent approval, if earlier. See
Securities Exchange Act Release No. 78037 (June 10, 2016), 81 FR
39299 (June 16, 2016) (SR-NASDAQ-2016-052).
    \6\ The term ``Firm'' or (``F'') applies to any transaction that
is identified by a Participant for clearing in the Firm range at
OCC.
    \7\ The term ``Non-NOM Market Maker'' or (``O'') is a registered
market maker on another options exchange that is not a NOM Market
Maker. A Non-NOM Market Maker must append the proper Non-NOM Market
Maker designation to orders routed to NOM.
    \8\ The term ``Broker-Dealer'' or (``B'') applies to any
transaction which is not subject to any of the other transaction
fees applicable within a particular category.
    \9\ MARS refers to the Market Access and Routing Subsidy, which
is set forth in Chapter XV, Section 6. The MARS payment currently
comprises of four volume-based tiers, and is paid to NOM
Participants that route eligible contracts to NOM through a
participating NOM Participant's routing system. The MARS payment is
paid on all executed eligible contracts that add liquidity. See NOM
Rules at Chapter XV, Section 6.
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    Currently, Customers and Professionals transacting in Non-Penny
Pilot Options on NOM receive a $0.80 per contract Rebate to Add
Liquidity, as set forth in Chapter XV, Section 2(1) of NOM Rules. In
addition, footnote ``1'' in Chapter XV, Section 2(1) provides that a
Participant that qualifies for a Customer or Professional Penny Pilot
Options Rebate to Add Liquidity in Tiers 2, 3, 4, 5 or 6 in a month
will receive an additional $0.10 per contract Non-Penny Pilot Options
Rebate to Add Liquidity for each transaction which adds liquidity in
Non-Penny Options in that month. A Participant that qualifies for
Customer or Professional Penny Pilot Options Rebate to Add Liquidity in
Tiers 7 or 8 in a month will receive an additional $0.20 per contract
Non-Penny Pilot Options Rebate to Add Liquidity for each transaction
which adds liquidity in Non-Penny Pilot Options in that month.
    In addition, note ``e'' in Chapter XV, Section 2(1) provides that a
Participant may receive a $0.53 per contract Rebate to Add Liquidity in
Penny Pilot Options as Customer or Professional, and a $1.00 per
contract Rebate to Add Liquidity in Non-Penny Pilot Options as a
Customer or Profession, if that NOM Participant transacts on the NASDAQ
Stock Market through one or more of its Nasdaq Market Center MPIDs in
the same month, and such transactions in all securities on the NASDAQ
Stock Market that month through all of its Nasdaq Market Center MPIDs
represent 3.00% or more of Consolidated Volume.\10\ Participants that
qualify for this rebate would not be eligible for any other rebates in
Tiers 1 through 8 or other rebate incentives on NOM for Customer and
Professional order flow in Chapter XV, Section 2(1) of NOM Rules.\11\
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    \10\ Consolidated Volume would be determined as set forth in
Nasdaq Rule 7018(a).
    \11\ In calculating total volume, the Exchange would add the NOM
Participant's total volume transacted on the NASDAQ Stock Market in
a given month across its Nasdaq Market Center MPIDs, and will divide
this number by the total industry Consolidated Volume.
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    Lastly, note ``f'' in Chapter XV, Section 2(1) provides that a
Participant may receive a $0.55 per contract Rebate to Add Liquidity in
Penny Pilot Options as Customer or Professional, and a $1.05 per
contract Rebate to Add Liquidity in

Non-Penny Pilot Options as Customer or Professional, if that NOM
Participant (a) adds Customer, Professional, Firm, Non-NOM Market Maker
and/or Broker-Dealer liquidity in Penny Pilot Options and/or Non-Penny
Pilot Options above 1.45% of total industry customer equity and ETF
option ADV contracts per day in a month (``NOM Volume Threshold''), (b)
executes greater than 0.04% of Consolidated Volume (``CV'') via Market-
on-Close/Limit-on-Close (``MOC/LOC'') \12\ volume within the NASDAQ
Stock Market Closing Cross within a month, and (c) adds greater than
1.5 million shares per day of non-displayed volume within the NASDAQ
Stock Market within a month. Participants that qualify for this rebate
would not be eligible for any other rebates in Tiers 1 through 8 or
other rebate incentives on NOM for Customer and Professional order flow
in Chapter XV, Section 2(1).
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    \12\ MOC/LOC, as set forth in NASDAQ Rule 4754, represents the
volume in the NASDAQ Stock Market Closing Cross that allows market
participants to contribute order flow that will result in executions
at the official closing price for the day in the NASDAQ listed
security. A ``MOC Order'' is an order type entered without a price
that may be executed only during the NASDAQ Closing Cross, which
refers to the equity closing cross. A ``LOC Order'' is an order type
entered with a price that may be executed only in the NASDAQ Closing
Cross.
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    The Exchange now proposes to amend the current qualifications for
earning the Rebate to Add Liquidity in note ``f'' by lowering the NOM
Volume Threshold. Specifically, the Exchange is proposing to continue
to pay a $0.55 per contract Rebate to Add Liquidity in Penny Pilot
Options as Customer or Professional, and a $1.05 per contract Rebate to
Add Liquidity in Non-Penny Pilot Options as Customer or Professional,
if that NOM Participant (a) adds Customer, Professional, Firm, Non-NOM
Market Maker and/or Broker-Dealer liquidity in Penny Pilot Options and/
or Non-Penny Pilot Options above 1.20% of total industry customer
equity and ETF option ADV contracts per day in a month, (b) executes
greater than 0.04% of CV via MOC/LOC volume within the NASDAQ Stock
Market Closing Cross within a month, and (c) adds greater than 1.5
million shares per day of non-displayed volume within the NASDAQ Stock
Market within a month.\13\
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    \13\ Participants that meet the new qualifications for the note
``f'' incentive would continue to be ineligible for any other
rebates in Tiers 1 through 8 or other rebate incentives on NOM for
Customer and Professional order flow in Chapter XV, Section 2(1).
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    The Exchange's proposal to lower the NOM Volume Threshold from
above 1.45% of total industry customer equity and ETF option ADV
contracts per day in a month to above 1.20% should provide Participants
the ability to qualify for this incentive by executing less contracts
which represent industry volume in a given month. The Exchange believes
that this amendment should incentivize Participants to transact more
volume to qualify for the rebate in footnote ``f'' since one of the
qualifiers requires a lower percentage of total industry customer
equity and ETF option ADV contracts per day in a month as compared to
the current percentage.
NOM Market Maker Non-Penny Pilot Options Fee for Adding Liquidity
    The Exchange proposes to offer Participants that send NOM Market
Maker \14\ order flow an opportunity to lower their Fee for Adding
Liquidity in Non-Penny Pilot Options, as set forth in Chapter XV,
Section 2(1). In particular, the Exchange proposes to offer
Participants the opportunity to reduce the NOM Market Maker Non-Penny
Pilot Options Fee for Adding Liquidity from $0.35 to $0.00 per
contract, provided the Participant adds NOM Market Maker liquidity in
Non-Penny Pilot Options of 7,500 or more ADV contracts per day in a
month.
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    \14\ The term ``NOM Market Maker'' or (``M'') is a Participant
that has registered as a Market Maker on NOM pursuant to Chapter
VII, Section 2, and must also remain in good standing pursuant to
Chapter VII, Section 4. In order to receive NOM Market Maker pricing
in all securities, the Participant must be registered as a NOM
Market Maker in at least one security.
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\15\ in general, and furthers the objectives of
Sections 6(b)(4) and 6(b)(5) of the Act,\16\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among members and issuers and other persons using any
facility, and is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(4) and (5).
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Customer and Professional Rebate to Add Liquidity
    The Exchange's proposal to lower the NOM Volume Threshold is
reasonable because the rebates in footnote ``f'' should continue to
attract Customer and Professional order flow to NOM. The additional
Customer and Professional order flow to NOM benefits other market
participants by providing additional liquidity with which to interact.
Customer liquidity offers unique benefits to the market by providing
more trading opportunities, which attracts market makers. An increase
in the activity of market makers in turn facilitates tighter spreads,
which may cause an additional corresponding increase in order flow from
other market participants. Furthermore, the Exchange believes that
encouraging Participants to add Professional liquidity creates
competition among options exchanges because the amended note ``f''
rebates may cause market participants to select NOM as a venue to send
Professional order flow. Amending the existing NOM Volume Threshold
affords more Participants the ability to qualify for the note ``f''
rebates because it requires less volume as a result of the proposed
lower percentage of industry volume. With this proposal, Participants
that consistently send order flow to the Exchange may continue to
qualify for the rebates in note ``f'' and other Participants may send
additional order flow to qualify for the note ``f'' rebates with the
lower requirement.
    The Exchange's proposal to lower the NOM Volume Threshold is
equitable and not unfairly discriminatory because all Participants are
eligible to earn rebates. These rebates would be paid uniformly to all
qualifying Participants.
NOM Market Maker Non-Penny Pilot Options Fee for Adding Liquidity
    The proposed change to offer Participants that send NOM Market
Maker order flow the opportunity to reduce the NOM Market Maker Non-
Penny Pilot Options Fee for Adding Liquidity from $0.35 to $0.00 per
contract, provided the Participant adds NOM Market Maker liquidity in
Non-Penny Pilot Options of 7,500 or more ADV contracts per day in a
month is reasonable because the Exchange seeks to encourage
Participants to add NOM Market Maker liquidity in Non-Penny Options to
obtain the discount. The Exchange believes that its proposal will
incentivize Participants to select NOM as a venue and in turn benefit
other market participants with the opportunity to interact with such
liquidity.
    Furthermore, the Exchange believes that its proposal to reduce the
NOM Market Maker fee as described above is equitable and not unfairly
discriminatory because NOM Market Makers, unlike other market
participants, add value through continuous quoting \17\ and the

commitment of capital. In addition, encouraging NOM Market Makers to
add greater liquidity benefits all Participants in the quality of order
interaction. The Exchange believes it is equitable and not unfairly
discriminatory to offer only NOM Market Makers the opportunity to earn
the discounted fee described above because of the obligations borne by
these market participants, as noted herein.
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    \17\ Pursuant to Chapter VII (Market Participants), Section 5
(Obligations of Market Makers), in registering as a market maker, an
Options Participant commits himself to various obligations.
Transactions of a Market Maker in its market making capacity must
constitute a course of dealings reasonably calculated to contribute
to the maintenance of a fair and orderly market, and Market Makers
should not make bids or offers or enter into transactions that are
inconsistent with such course of dealings. Further, all Market
Makers are designated as specialists on NOM for all purposes under
the Act or rules thereunder. See Chapter VII, Section 5.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. In terms of inter-market
competition, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues if they deem fee levels at a particular venue to be
excessive, or rebate opportunities available at other venues to be more
favorable. The Exchange believes that the proposed pricing changes are
competitive and does not impose a burden on inter-market competition.
If the changes proposed herein are unattractive to market participants,
it is likely that the Exchange will lose market share as a result.
Accordingly, the Exchange does not believe that the proposed changes
will impair the ability of members or competing order execution venues
to maintain their competitive standing in the financial markets.
    As it relates to the proposed fee change to lower the NOM Volume
Threshold, the Exchange does not believe that its proposal imposes an
undue burden on intra-market competition because all Participants are
eligible to earn rebates and these rebates would be uniformly paid to
all qualifying Participants. The Exchange also does not believe that
its proposal to offer Participants an opportunity to reduce the NOM
Market Maker Non-Penny Pilot Options Fee for Adding Liquidity from
$0.35 to $0.00 if they meet the volume-based standard described above
imposes an undue burden on intra-market competition because NOM Market
Makers, unlike other market participants, add value through continuous
quoting \18\ and the commitment of capital.
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    \18\ See note 17 above.
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\19\
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    \19\ 15 U.S.C. 78s(b)(3)(A)(ii).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2017-080 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2017-080. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet 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 Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office 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-NASDAQ-2017-080, and should
be submitted on or before September 5, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
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    \20\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-17169 Filed 8-14-17; 8:45 am]
 BILLING CODE 8011-01-P