[Federal Register Volume 80, Number 6 (Friday, January 9, 2015)]
[Notices]
[Pages 1422-1423]
[FR Doc No: 2015-00130]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2347]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Food and Cosmetic Export Certificate Application
Process

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 and
to allow 60 days for public comment in response to the notice. This
notice invites comments on the information collection provisions
associated with export certificate applications for FDA regulated food
and cosmetic products.

DATES: Submit either electronic or written comments on the collection
of information by March 10, 2015.

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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<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 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.

Food and Cosmetic Export Certificate Application Process (21 U.S.C.
381(e)) (OMB Control Number 0910-NEW)

    Some foreign countries require manufacturers of FDA regulated
products to provide an export certificate for the products they wish to
export to that country. A Certificate of Free Sale is a certificate
(not pertaining to a particular production lot or export consignment)
that indicates that the particular product is marketed in the United
States or eligible for export, and that the particular manufacturer has
no unresolved enforcement actions pending before or taken by FDA. FDA's
Center for Food Safety and Applied Nutrition (CFSAN) issues such
certificates for food, food additives, seafood, dietary supplements,
and cosmetics. Interested persons may request a certificate by using
the electronic CFSAN Certificate Application Process, which is part of
FDA Unified Registration and Listing System, or by submitting a paper
Form FDA 3613d for cosmetic products or a paper Form FDA 3613e for food
products. We use the information submitted to determine whether to
issue the requested certificate.
    OMB has approved the submission of requests for export certificates
on paper Forms FDA 3613d and FDA 3613e and, electronically, via the
CFSAN Certificate Application Process under OMB control number 0910-
0498. This notice announces that, to ensure the efficient review of the
information collection by OMB under the PRA, we are seeking to obtain a
new OMB control number for Forms FDA 3613d and FDA 3613e and the CFSAN
Certificate Application Process to reflect that the electronic
submission system for food and cosmetic export certificates is separate
from the electronic submission system associated with export
certificates for other FDA regulated products approved under OMB
control number 0910-0498. Upon OMB approval of this information
collection request, we will adjust the burden hours associated with
Forms FDA 3613d and FDA 3613e and the CFSAN Certificate Application
Process approved under OMB control number 0910-0498.
    We request the following information on Form FDA 3613d and the
CFSAN Certificate Application Process, as currently approved by OMB:
The name of and contact information for the requester; the name of and
contact information for the exporting company (if different from
requester); a designation of the type of certificate requested
(``general'' or ``product-specific''); if product-specific, a list of
the exact brand names of the products; the contact person, company name
and address where the requested certificate should be sent; and, the
name and account number (if applicable) of the requester's preferred
carrier for delivery of the certificate. Finally, Form FDA 3613d and
the CFSAN Certificate Application Process requires the requester's
signature, the name and title of the person signing the form, as well
as the date signed.
    We request the following information on Form FDA 3613e and the
CFSAN Certificate Application Process, as currently approved by OMB:
The name of and contact information for the manufacturer, as well as
the manufacturer's state license or registration number; the name of
and contact information for the exporting company (if different from
manufacturer), as well as the exporting company's state license or
registration number; a description of the shipment including the
product, the common name, the manufacturer, and a description or
additional comments; the name of the country to which the requester of
the certificate intends to ship the product; the contact person, firm
name and address where the requested certificate should be sent; and,
the name and account number (if applicable) of the requester's
preferred carrier for delivery of the certificate. Form FDA 3613e and
the CFSAN Certificate Application Process requires the requestor to
submit an original or copy of the applicable product label or labels.
Finally, Form FDA 3613e and the CFSAN Certificate Application Process

requires the submitter's signature, the name and title of the person
signing the form, as well as the date signed.
    Description of Respondents: The respondents to this collection of
information are firms interested in exporting U.S.-manufactured food
and cosmetic products to foreign countries that require export
certificates.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                   Type of respondent                        FDA form        Number of     responses per   Total annual   Average burden    Total hours
                                                            number \2\      respondents     respondent       responses     per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cosmetics...............................................           3613d             600               1             600             1.5             900
Conventional Food (Including Seafood)...................           3613e             398               1             398             1.5             597
Dietary Supplements, Food for Special Dietary Use,                 3613e           2,129               4           2,129             1.5           3,194
 Infant Formula, and Medical Foods......................
Food Additives and Food Contact Substances..............           3613e             167               1             167             1.5             251
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............           4,942
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ Form FDA 3613d and Form FDA 3613e may be submitted electronically via the Certificate Application Process.

    For the purpose of this information collection request, we are
basing our estimate of the average burden per response in column 6 of
Table 1 on the estimates previously submitted to and approved by OMB
under control number 0910-0498. Our estimate of the average burden per
response in column 6 of Table 1 varies according to the product
category for which the certificate is requested. We base our estimates
of the total annual responses in column 5 of Table 1 on our experience
with certificate applications received in the past 2 fiscal years. Some
respondents send in requests as often as three or four times a month
while others may submit only periodic requests.
    We expect that most if not all firms requesting export certificates
in the next 3 years will choose to take advantage of the option of
electronic submission via the CFSAN Certificate Application Process.
Thus, our burden estimates in Table 1 are based on the expectation of
100 percent participation in the electronic submission process. The
opportunity to provide the information in electronic format could
reduce the Agency's previous estimates for the time to prepare each
submission. However, as a conservative approach for the purpose of this
analysis, we are assuming that the opportunity to submit the
information in electronic format will have no effect on the average
time to prepare a submission.

    Dated: January 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00130 Filed 1-8-15; 8:45 am]
BILLING CODE 4164-01-P


"Schwab, Margo"<EMAIL_ADDRESS> 06/08/2007 11:57 AM

To

Lydia Wegman/RTP/USEPA/US@EPA

cc

Karen Martin/RTP/USEPA/US@EPA

Subject

RE: Response to questions about exposures of concern

Thank you both.

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Friday, June 08, 2007 10:05 AM

To: Schwab, Margo; Johansson, Robert; Frey, Patrick J.

Cc: Fraas, Arthur G<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS> Subject: Response to questions about exposures of concern

Margo, Rob and Patrick,

Attached is our response to the questions Margo and I discussed related

to exposures of concern.   We agree with Margo that we need to have a

discussion along the lines of what is in the response to the first

question much earlier in the preamble than it currently appears.  We

believe it most likely should appear on pp. 16-17, as Margo has

suggested.   Perhaps we can discuss this at our 1 PM meeting.

----- Forwarded by Lydia Wegman/RTP/USEPA/US on 06/08/2007 10:02 AM

-----

             Karen

             Martin/RTP/USEPA

             /US                                                     To

                                      Wegman Lydia@EPA

             06/08/2007 10:01                                        cc

             AM

                                                                Subject

                                      Exposures of concern

(See attached file: Exposures of concern June8.doc)

Karen Martin, Ph.D.

Office of Air Quality Planning and Standards U.S. EPA (C504-06) Research

Triangle Park, NC 27711

phone:<PHONE_NUMBER>

fax:<PHONE_NUMBER>

<EMAIL_ADDRESS>


--Final FRA disapproval and    279 railroads......  20 amended plans...  1 hour.............              20
     plan amendment.
213.119--Continuous welded rail
 (CWR); plan contents:
    --Annual CWR training of       279 railroads......  8,000 trained        30 minutes.........           4,000
     employees.                                          employees.
    --Record keeping.............  279 railroads......  2,000 records......  10 minutes.........             333
    --Record keeping for CWR rail  279 railroads......  360,000 rcds.......  2 minutes..........          12,000
     joints.
    --Periodic records for CWR     279 railroads......  480,000 rcds.......  1 minute...........           8,000
     rail joints.
    --Copy of track owner's CWR    279 railroads......  279 manuals........  10 minutes.........              47
     procedures.
213.233--Track inspections--       763 railroads......  12,500 notations...  1 minute...........             208
 Notations.
213.241--Inspection records......  763 railroads......  1,542,089 records..  Varies.............       1,672,941
213.303--Responsibility for        2 railroads........  1 notification.....  8 hours............               8
 compliance.
213.305--Designation of qualified
 individuals; general
 qualifications:
    --Designations (partially      2 railroads........  20 designations....  10 minutes.........               3
     qualified).
213. 317--Waivers................  2 railroads........  1 petition.........  80 hours...........              80
213.329--Curves, elevation and     2 railroads........  3 notifications....  40 hours...........             120
 speed limitations.
    --Written notification.......  2 railroads........  3 notifications....  45 minutes.........               2
213.333--Automated vehicle         2 railroads + 1      18 reports.........  20 hours...........             360
 inspection systems.                possible future
                                    railroad.
    --Track/vehicle performance    2 railroads........  13 printouts.......  20 hours...........             260
     measurement system.
213.341--Initial inspection of
 new rail and welds:
    --Mill inspection............  2 railroads........  2 reports..........  16 hours...........              32
    --Welding plant inspection...  2 railroads........  2 reports..........  16 hours...........              32
    --Inspection of field welds..  2 railroads........  125 reports........  20 minutes.........              42
213.343--Continuous welded rail    2 railroads........  150 records........  10 minutes.........              25
 (CWR).
213.345--Vehicle qualification     1 railroad.........  2 reports..........  560 hours..........           1,120
 testing.
213.369--Inspection records......  2 railroads........  500 records........  1 minute...........               8
    --Inspection defects +         2 railroads........  50 records.........  5 minutes..........               4
     remedial action.
----------------------------------------------------------------------------------------------------------------

    All estimates include the time for reviewing instructions;
searching existing data sources; gathering or maintaining the needed
data; and reviewing the information. Pursuant to 44 U.S.C.
3506(c)(2)(B), FRA solicits comments concerning the following: whether
these information collection requirements are necessary for the proper
performance of the functions of FRA, including whether the information
has practical utility; the accuracy of FRA's estimates of the burden of
the information collection requirements; the quality, utility, and
clarity of the information to be collected; and whether the burden of
collection of information on those who are to respond, including
through the use of automated collection techniques or other forms of
information technology, may be minimized. For information or a copy of
the paperwork package submitted to OMB, contact Mr. Robert Brogan,
Office of Railroad Safety, Information Clearance Officer, at 202-493-
6292, or Ms. Kimberly Toone, Office of Financial Management and
Administration, Information Clearance Officer, at<PHONE_NUMBER>.
    Organizations and individuals desiring to submit comments on the
collection of information requirements should direct them to Mr. Robert
Brogan or Ms. Kimberly Toone, Federal Railroad Administration, 1200 New
Jersey Avenue SE., 3rd Floor, Washington, DC 20590. Comments may also
be submitted via email to Mr. Brogan or Ms. Toone at the following
address<EMAIL_ADDRESS><EMAIL_ADDRESS>    OMB is required to make a decision concerning the collection of
information requirements contained in this proposed rule between 30 and
60 days after publication of this document in the Federal Register.
Therefore, a comment to OMB is best assured of having its full effect
if OMB receives it within 30 days of publication. The final rule and
associated information collection submission will respond to any OMB or
public comments on the information collection requirements contained in
this proposal.
    FRA is not authorized to impose a penalty on persons for violating
information collection requirements that do not display a current OMB
control number, if required. FRA intends to obtain current OMB control
numbers for any new information collection requirements resulting from
this rulemaking action prior to the effective date of the eventual
final rule. The OMB control number, when assigned, will be announced by
separate notice in the Federal Register.

D. Environmental Impact

    FRA has evaluated this NPRM in accordance with its ``Procedures for
Considering Environmental Impacts'' (FRA's Procedures) (64 FR 28545,
May 26, 1999) as required by the National Environmental Policy Act (42
U.S.C. 4321 et seq.), other environmental statutes, Executive Orders,
and related regulatory requirements. FRA has determined that this
action is not a major FRA action (requiring the preparation of an
environmental impact statement or environmental assessment) because it
is categorically excluded from detailed environmental review pursuant
to section 4(c)(20) of FRA's Procedures. 64 FR 28547, May 26, 1999. In
accordance with section 4(c) and (e) of FRA's Procedures, the agency
has further concluded that no extraordinary circumstances exist with
respect to this NPRM that might trigger the need for a more detailed
environmental review. As a result, FRA finds that this NPRM is not a
major Federal action significantly affecting the quality of the human
environment.

E. Federalism Implications

    Executive Order 13132, ``Federalism'' (64 FR 43255, Aug. 10, 1999),
requires FRA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' are defined in the Executive Order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' Under Executive Order 13132, the agency
may not issue a regulation with federalism implications that imposes
substantial direct compliance costs and that is not required by
statute, unless the Federal government provides the funds necessary to
pay the direct compliance costs incurred by State and local governments
or the agency consults with State and local government officials early
in the process of developing the regulation. Where a regulation has
federalism implications and preempts State law, the agency seeks to
consult with State and local officials in the process of developing the
regulation.
    FRA has analyzed this proposed rule in accordance with the
principles and criteria contained in Executive Order 13132. If adopted,
this proposed rule would not have a substantial direct effect on the
States, on the relationship between the Federal government and the
States, or on the distribution of power and responsibilities among the
various levels of government. FRA has also determined that this
proposed rule would not impose substantial direct compliance costs on
State and local governments. Therefore, the consultation and funding
requirements of Executive Order 13132 do not apply.
    Moreover, FRA notes that RSAC, which endorsed and recommended the
majority of this proposed rule, has as permanent members, two
organizations representing State and local interests: AASHTO and ASRSM.
Both of these State organizations concurred with the RSAC
recommendation made in this rulemaking. RSAC regularly provides
recommendations to the Administrator of FRA for solutions to regulatory
issues that reflect significant input from its State members. To date,
FRA has received no indication of concerns about the federalism
implications of this rulemaking from these representatives or from any
other representatives of State government.
    However, if adopted, this proposed rule could have preemptive
effect by operation of law under 49 U.S.C. 20106 (Sec. 20106). Section
20106 provides that States may not adopt or continue in effect any law,
regulation, or order related to railroad safety or security that covers
the subject matter of a regulation prescribed or order issued by the
Secretary of Transportation (with respect to railroad safety matters)
or the Secretary of Homeland Security (with respect to railroad
security matters), except when the State law, regulation, or order
qualifies under the ``local safety or security hazard'' exception to
section 20106.
    In sum, FRA has analyzed this proposed rule in accordance with the
principles and criteria contained in Executive Order 13132. As
explained above, FRA has determined that this proposed rule has no
federalism implications, other than the possible preemption of State
laws under Sec. 20106. Accordingly, FRA has determined that preparation
of a federalism summary impact statement for this proposed rule is not
required.

F. Unfunded Mandates Reform Act of 1995

    Pursuant to section 201 of the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4, 2 U.S.C. 1531), each Federal agency ``shall, unless
otherwise prohibited by law, assess the effects of Federal regulatory
actions on State, local, and tribal governments, and the private sector
(other than to the extent

that such regulations incorporate requirements specifically set forth
in law).'' Section 202 of the Act (2 U.S.C. 1532) further requires that
``before promulgating any general notice of proposed rulemaking that is
likely to result in the promulgation of any rule that includes any
Federal mandate that may result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) [currently
$143,100,000 in 2010 dollars] in any 1 year, and before promulgating
any final rule for which a general notice of proposed rulemaking was
published, the agency shall prepare a written statement'' detailing the
effect on State, local, and tribal governments and the private sector.
This NPRM will not result in the expenditure, in the aggregate, of
$143,100,000 in 2010 dollars or more in any one year, and thus
preparation of such a statement is not required

G. Energy Impact

    Executive Order 13211 requires Federal agencies to prepare a
Statement of Energy Effects for any ``significant energy action.'' See
66 FR 28355 (May 22, 2001). Under the Executive Order a ``significant
energy action'' is defined as any action by an agency that promulgates
or is expected to lead to the promulgation of a final rule or
regulation, including notices of inquiry, advance notices of proposed
rulemaking, and notices of proposed rulemaking: (1)(i) That is a
significant regulatory action under Executive Order 12866 or any
successor order, and (ii) is likely to have a significant adverse
effect on the supply, distribution, or use of energy; or (2) that is
designated by the Administrator of the Office of Information and
Regulatory Affairs as a significant energy action. FRA has evaluated
this NPRM in accordance with Executive Order 13211. FRA has determined
that this NPRM is not likely to have a significant adverse effect on
the supply, distribution, or use of energy. Consequently, FRA has
determined that this NPRM is not a ``significant energy action'' within
the meaning of the Executive Order.

H. Privacy Act Statement

    Anyone is able to search the electronic form of all comments
received into any of DOT's dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). Please visit http://www.regulations.gov/#!privacyNotice. You may review DOT's complete
Privacy Act Statement published in the Federal Register on April 11,
2000 (Volume 65, Number 70, Pages 19477-78), or you may visit http://
www.dot.gov/privacy.html.

List of Subjects in 49 CFR Part 213

    Penalties, Railroad safety, Reporting and recordkeeping
requirements.

The Proposed Rule

    For the reasons discussed in the preamble, FRA proposes to amend
part 213 of chapter II, subtitle B of title 49, Code of Federal
Regulations, as follows:

PART 213--[AMENDED]

    1. The authority citation for part 213 continues to read as
follows:

    Authority:  49 U.S.C. 20102-20114 and 20142; Sec. 403, Div. A,
Pub. L. 110-432, 122 Stat. 4885; 28 U.S.C. 2461, note; and 49 CFR
1.49.

Subpart A--General

    2. Section 213.3 is amended by revising paragraph (b) to read as
follows:

Sec.  213.3  Application.

* * * * *
    (b) This part does not apply to track--
    (1) Used exclusively for rapid transit operations in an urban area
that are not connected to the general railroad system of
transportation.
    (2) Located inside an installation that is not part of the general
railroad system of transportation (i.e., a plant railroad). As used in
this part, plant railroad means a plant or installation that owns or
leases a locomotive, uses that locomotive to switch cars throughout the
plant or installation, and is moving goods solely for use in the
facility's own industrial processes. The plant or installation could
include track immediately adjacent to the plant or installation if the
plant railroad leases the track from the general system railroad and
the lease provides for (and actual practice entails) the exclusive use
of that track by the plant railroad and the general system railroad for
purposes of moving only cars shipped to or from the plant. A plant or
installation that operates a locomotive to switch or move cars for
other entities, even if solely within the confines of the plant or
installation, rather than for its own purposes or industrial processes,
will not be considered a plant railroad because the performance of such
activity makes the operation part of the general railroad system of
transportation. Similarly, this exclusion does not apply to track over
which a general system railroad operates, even if that track is located
within a plant railroad.

Subpart D--Track Structure

    3. Section 213.113 is revised to read as follows:

Sec.  213.113  Defective rails.

    (a) When an owner of track learns that a rail in the track contains
any of the defects listed in the table contained in paragraph (c) of
this section, a person designated under Sec.  213.7 shall determine
whether the track may continue in use. If the designated person
determines that the track may continue in use, operation over the
defective rail is not permitted until--
    (1) The rail is replaced or repaired; or
    (2) The remedial action prescribed in the table contained in
paragraph (c) of this section is initiated.
    (b) When an owner of track learns that a rail in the track contains
an indication of any of the defects listed in the table contained in
paragraph (c) of this section, the track owner shall verify the
indication. The track owner must verify the indication within four
hours, unless the track owner has an indication of the existence of the
defects that require remedial action A, A2, or B identified in the
table contained in paragraph (c) of this section, in which case the
track owner must immediately verify the indication. If the indication
is verified, the track owner must--
    (1) Replace or repair the rail; or
    (2) Initiate the remedial action prescribed in the table contained
in paragraph (c) of this section.
    (c) Remedial action table. A track owner who learns that a rail
contains one of the following defects shall prescribe the remedial
action specified if the rail is not replaced or repaired:

                                                                  Remedial Action Table
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               Length of defect (inch(es))              Percentage of existing rail head cross-    If the defective rail
                                    ------------------------------------------------       sectional area weakened by defect        is not  replaced or
               Defect                                                               ----------------------------------------------   repaired, take the
                                            More than           But not more than                                                     remedial action
                                                                                Less than          But not less than      prescribed in note
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compound Fissure...................  ......................  ......................  70...................  5....................  B.
                                     ......................  ......................  100..................  70...................  A2.
                                     ......................  ......................  .....................  100..................  A.
Transverse Fissure.................  ......................  ......................  25...................  5....................  C.
Detail Fracture....................  ......................  ......................  60...................  25...................  D.
Engine Burn Fracture...............  ......................  ......................  100..................  60...................  A2, or [E and H].
Defective Weld.....................  ......................  ......................  .....................  100..................  A, or [E and H].
Horizontal Split Head
Vertical Split Head
    Split Web......................  1.....................  2.....................  .....................  .....................  H and F.
    Piped Rail.....................  2.....................  4.....................  .....................  .....................  I and G.
    Head Web Separation............  4.....................  ......................  .....................  .....................  B.
    Defective Weld (Longitudinal)..  (1)...................  (1)...................  .....................  .....................  A.
Bolt Hole Crack....................  \3/4\.................  1.....................  .....................  .....................  H and F.
                                     1.....................  1\1/2\................  .....................  .....................  H and G.
                                     1.....................  ......................  .....................  .....................  B.
                                     1\1/2\................
                                     (\1\).................  (\1\).................  .....................  .....................  A.
Broken Base........................  1.....................  6.....................  .....................  .....................  D.
                                     6 \2\.................  ......................  .....................  .....................  A, or [E and I].
Ordinary Break.....................  ......................  ......................  .....................  .....................  A or E.
Damaged Rail.......................  ......................  ......................  .....................  .....................  C.
Flattened Rail Crushed Head........  Depth > \3/8\ and       ......................  .....................  .....................  H.
                                      Length > 8.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Break out in rail head.
\2\ Remedial action D applies to a moon-shaped breakout, resulting from a derailment, with length greater than 6 inches but not exceeding 12 inches and
  width not exceeding one-third of the rail base width.

    Notes:
    A. Assign a person designated under Sec.  213.7 to visually
supervise each operation over the defective rail.
    A2. Assign a person designated under Sec.  213.7 to make a visual
inspection. After a visual inspection, that person may authorize
operation to continue without continuous visual supervision at a
maximum of 10 m.p.h. for up to 24 hours prior to another such visual
inspection or replacement or repair of the rail.
    B. Limit operating speed over the defective rail to that as
authorized by a person designated under Sec.  213.7(a), who has at
least one year of supervisory experience in railroad track maintenance.
The operating speed cannot be over 30 m.p.h. or the maximum allowable
speed under Sec.  213.9 for the class of track concerned, whichever is
lower.
    C. Apply joint bars bolted only through the outermost holes to the
defect within 10 days after it is determined to continue the track in
use. In the case of Class 3 through 5 track, limit the operating speed
over the defective rail to 30 m.p.h. until joint bars are applied;
thereafter, limit the speed to 50 m.p.h. or the maximum allowable speed
under Sec.  213.9 for the class of track concerned, whichever is lower.
When a search for internal rail defects is conducted under Sec.
213.237, and defects are discovered in Class 3 through 5 track that
require remedial action C, the operating speed shall be limited to 50
m.p.h., or the maximum allowable speed under Sec.  213.9 for the class
of track concerned, whichever is lower, for a period not to exceed 4
days. If the defective rail has not been removed from the track or a
permanent repair made within 4 days of the discovery, limit operating
speed over the defective rail to 30 m.p.h. until joint bars are
applied; thereafter, limit speed to 50 m.p.h. or the maximum allowable
speed under Sec.  213.9 for the class of track concerned, whichever is
lower. When joint bars have not been applied within 10 days, the speed
must be limited to 10 m.p.h. until joint bars are applied.
    D. Apply joint bars bolted only through the outermost holes to
defect within 7 days after it is determined to continue the track in
use. In the case of Class 3 through 5 track, limit operating speed over
the defective rail to 30 m.p.h. or less as authorized by a person
designated under Sec.  213.7(a), who has at least one year of
supervisory experience in railroad track maintenance, until joint bars
are applied; thereafter, limit speed to 50 m.p.h. or the maximum
allowable speed under Sec.  213.9 for the class of track concerned,
whichever is lower. When joint bars have not been applied within 7
days, the speed must be limited to 10 m.p.h. until the joint bars are
applied.
    E. Apply joint bars to the defect and bolt in accordance with Sec.
213.121(d) and (e).
    F. Inspect the rail within 90 days after it is determined to
continue the track in use. If the rail remains in track and is not
replaced or repaired, the reinspection cycle starts over with each
successive reinspection unless the reinspection reveals the rail defect
to have increased in size and therefore become subject to a more
restrictive remedial action. This process continues indefinitely until
the rail is removed from the track or repaired. If not inspected within
90 days, limit speed to that for Class 2 track or the maximum allowable
speed under Sec.  213.9 for the class of track concerned, whichever is
lower, until it is inspected.
    G. Inspect rail within 30 days after it is determined to continue
the track in use. If the rail remains in the track and is not replaced
or repaired, the reinspection cycle starts over with each successive
reinspection unless the

reinspection reveals the rail defect to have increased in size and
therefore become subject to a more restrictive remedial action. This
process continues indefinitely until the rail is removed from the track
or repaired. If not inspected within 30 days, limit speed to that for
Class 2 track or the maximum allowable speed under Sec.  213.9 for the
class of track concerned, whichever is lower, until it is inspected.
    H. Limit operating speed over the defective rail to 50 m.p.h. or
the maximum allowable speed under Sec.  213.9 for the class of track
concerned, whichever is lower.
    I. Limit operating speed over the defective rail to 30 m.p.h. or
the maximum allowable speed under Sec.  213.9 for the class of track
concerned, whichever is lower.
    (d) As used in this section--
    (1) Bolt hole crack means a crack across the web, originating from
a bolt hole, and progressing on a path either inclined upward toward
the rail head or inclined downward toward the base. Fully developed
bolt hole cracks may continue horizontally along the head/web or base/
web fillet, or they may progress into and through the head or base to
separate a piece of the rail end from the rail. Multiple cracks
occurring in one rail end are considered to be a single defect.
However, bolt hole cracks occurring in adjacent rail ends within the
same joint must be reported as separate defects.
    (2) Broken base means any break in the base of the rail.
    (3) Compound fissure means a progressive fracture originating from
a horizontal split head that turns up or down, or in both directions,
in the head of the rail. Transverse development normally progresses
substantially at a right angle to the length of the rail.
    (4) Crushed head means a short length of rail, not at a joint,
which has drooped or sagged across the width of the rail head to a
depth of \3/8\ inch or more below the rest of the rail head and 8
inches or more in length. Unlike flattened rail where the depression is
visible on the rail head only, the sagging or drooping is also visible
in the head/web fillet area.
    (5) Damaged rail means any rail broken or otherwise damaged by a
derailment, broken, flat, or unbalanced wheel, wheel slipping, or
similar causes.
    (6) Defective weld means a field or plant weld containing any
discontinuities or pockets, exceeding 5 percent of the rail head area
individually or 10 percent in the aggregate, oriented in or near the
transverse plane, due to incomplete penetration of the weld metal
between the rail ends, lack of fusion between weld and rail end metal,
entrainment of slag or sand, under-bead or shrinkage cracking, or
fatigue cracking. Weld defects may originate in the rail head, web, or
base, and in some cases, cracks may progress from the defect into
either or both adjoining rail ends. If the weld defect progresses
longitudinally through the weld section, the defect is considered a
split web for purposes of remedial action required by this section.
    (7) Detail fracture means a progressive fracture originating at or
near the surface of the rail head. These fractures should not be
confused with transverse fissures, compound fissures, or other defects
which have internal origins. Detail fractures may arise from shelled
spots, head checks, or flaking.
    (8) Engine burn fracture means a progressive fracture originating
in spots where driving wheels have slipped on top of the rail head. In
developing downward they frequently resemble the compound or even
transverse fissures with which they should not be confused or
classified.
    (9) Flattened rail means a short length of rail, not at a joint,
which has flattened out across the width of the rail head to a depth of
\3/8\ inch or more below the rest of the rail and 8 inches or more in
length. Flattened rail occurrences have no repetitive regularity and
thus do not include corrugations, and have no apparent localized cause
such as a weld or engine burn. Their individual length is relatively
short, as compared to a condition such as head flow on the low rail of
curves.
    (10) Head and web separation means a progressive fracture,
longitudinally separating the head from the web of the rail at the head
fillet area.
    (11) Horizontal split head means a horizontal progressive defect
originating inside of the rail head, usually \1/4\ inch or more below
the running surface and progressing horizontally in all directions, and
generally accompanied by a flat spot on the running surface. The defect
appears as a crack lengthwise of the rail when it reaches the side of
the rail head.
    (12) Ordinary break means a partial or complete break in which
there is no sign of a fissure, and in which none of the other defects
described in this paragraph (d) is found.
    (13) Piped rail means a vertical split in a rail, usually in the
web, due to failure of the shrinkage cavity in the ingot to unite in
rolling.
    (14) Split web means a lengthwise crack along the side of the web
and extending into or through it.
    (15) Transverse fissure means a progressive crosswise fracture
starting from a crystalline center or nucleus inside the head from
which it spreads outward as a smooth, bright, or dark round or oval
surface substantially at a right angle to the length of the rail. The
distinguishing features of a transverse fissure from other types of
fractures or defects are the crystalline center or nucleus and the
nearly smooth surface of the development which surrounds it.
    (16) Vertical split head means a vertical split through or near the
middle of the head, and extending into or through it. A crack or rust
streak may show under the head close to the web or pieces may be split
off the side of the head.
    4. Section 213.119 is amended by removing and reserving paragraph
(h)(7)(ii) to read as follows:

Sec.  213.119  Continuous welded rail (CWR); plan contents.

* * * * *
    (h) * * *
    (7) * * *
    (ii) [Reserved]
* * * * *

Subpart F--Inspection

    5. Section 213.237 is revised to read as follows:

Sec.  213.237  Inspection of rail.

    (a) In addition to the inspections required by Sec.  213.233, a
track owner shall conduct internal rail inspections sufficient to
maintain service failure rates per rail inspection segment in
accordance with this paragraph (a) for a 12-month period as determined
by the track owner and calculated within 45 days of the end of the
period. These rates shall not include service failures that occur in
rail that has been replaced through rail relay since the time of the
service failure. Rail used to repair a service failure defect is not
considered rail relay. The service failure rates shall not exceed--
    (1) 0.1 service failure per year per mile of track for all Class 4
and 5 track;
    (2) 0.09 service failure per year per mile of track for all Class
3, 4, and 5 track that carries regularly-scheduled passenger trains or
is a hazardous material route; and
    (3) 0.08 service failure per year per mile of track for all Class
3, 4, and 5 track that carries regularly-scheduled passenger trains and
is a hazardous material route.
    (b) Each rail inspection segment shall be designated by the track
owner no later than [DATE 60 DAYS AFTER DATE OF PUBLICATION OF THE
FINAL RULE IN THE Federal Register]

for track that is Class 4 or 5 track, or Class 3 track that carries
regularly-scheduled passenger trains or is a hazardous material route
and is used to determine the milepost limits for the individual rail
inspection frequency.
    (1) To change the designation of a rail inspection segment or to
establish a new segment pursuant to this section, a track owner may
submit a detailed request to the FRA Associate Administrator for
Railroad Safety/Chief Safety Officer (Associate Administrator). Within
30 days of receipt of the submission, FRA will review the request. FRA
will approve, disapprove or conditionally approve the submitted
request, and will provide written notice of its determination.
    (2) The track owner's existing designation shall remain in effect
until the track owner's new designation is approved or conditionally
approved by FRA.
    (3) The track owner shall, upon receipt of FRA's approval or
conditional approval, establish the designation's effective date. The
track owner shall advise in writing FRA and all affected railroad
employees of the effective date.
    (c) Internal rail inspections on Class 4 and 5 track, or Class 3
track with regularly-scheduled passenger trains or that is a hazardous
materials route, shall not exceed a time interval of 370 days between
inspections or a tonnage interval of 30 million gross tons (mgt)
between inspections, whichever is shorter. Internal rail inspections on
Class 3 track that is without regularly-scheduled passenger trains and
not a hazardous materials route must be inspected at least once each
calendar year, with no more than 18 months between inspections, or at
least once every 30 mgt, whichever interval is longer, with the
additional provision that inspections cannot be more than 5 years
apart.
    (1) Any rail used as a replacement plug rail in track that is
required to be tested in accordance with this section must have been
tested for internal rail flaws.
    (2) The track owner must be able to verify that the plug rail has
not accumulated more than a total of 30 mgt in previous and new
locations since its last internal rail flaw test, before the next test
on the rail required by this section is performed.
    (3) If plug rail not in compliance with paragraphs (c)(1) and (2)
of this section is in use after [DATE OF PUBLICATION OF THE FINAL RULE
IN THE Federal Register], trains over that rail must not exceed Class 2
speeds until the rail is tested in accordance with this section.
    (d) If the service failure rate target identified in paragraph (a)
of this section is not achieved, the track owner must inform FRA of
this fact within 45 days of the end of the defined 12-month period in
which the performance target is exceeded. In addition, the owner may
provide to FRA an explanation as to why the performance target was not
achieved and provide a remedial action plan.
    (1) If the performance target rate is not met for two consecutive
years, then for the area where the greatest number of service failures
is occurring, either:
    (i) The inspection tonnage interval between tests must be reduced
to 10 mgt; or
    (ii) The class of track must be reduced to Class 2 until the target
service failure rate is achieved.
    (2) In cases where a single service failure would cause the rate to
exceed the applicable service failure rate as designated in paragraph
(a) of this section, the service failure rate will be considered to
comply with paragraph (a) of this section unless a second such failure
occurs within a designated 12-month period.
    (3) For the purposes of paragraph (d)(2) of this section, a period
begins no earlier than [DATE OF PUBLICATION OF THE FINAL RULE IN THE
Federal Register].
    (e) Each defective rail shall be marked with a highly visible
marking on both sides of the web and base except that, where a side or
sides of the web and base are inaccessible because of permanent
features, the highly visible marking shall be placed on or next to the
head of the rail.
    (f) Inspection equipment shall be capable of detecting defects
between joint bars, in the area enclosed by joint bars.
    (g) If the qualified rail defect detection equipment operator
determines that a valid search for internal defects could not be made
over a particular length of track, that particular length of track may
not be considered as internally inspected under paragraphs (a) and (c)
of this section.
    (h) If a valid search for internal defects cannot be conducted, the
track owner shall, before expiration of the time or tonnage limits in
paragraphs (a) or (c) of this section--
    (1) Conduct a valid search for internal defects;
    (2) Reduce operating speed to a maximum of 25 m.p.h. until such
time as a valid search can be made; or
    (3) Replace the rail that had not been inspected.
    (i) The person assigned to operate the rail defect detection
equipment must be a qualified operator as defined in Sec.  213.238 and
have demonstrated proficiency in the rail flaw detection process for
each type of equipment the operator is assigned.
    (j) As used in this section--
    (1) Hazardous materials route means any track of any class over
which a minimum of 10,000 car loads or intermodal portable tank car
loads of hazardous material as defined in 49 CFR 171.8 travel over a
period of one year; or Class 3, 4 or 5 track over which a minimum of
4,000 car loads or intermodal portable tank car loads of the hazardous
material specified in 49 CFR 172.820 travel, in a period of one year.
    (2) Plug rail means a length of rail that has been removed from one
track location and stored for future use as a replacement rail at
another location.
    (3) Service failure means a broken rail occurrence, the cause of
which is determined to be a compound fissure, transverse fissure,
detail fracture, or vertical split head.
    (4) Valid search means a continuous inspection for internal rail
defects where the equipment is performing as intended and equipment
responses are interpreted by a qualified operator as defined in Sec.
213.238.
    6. Section 213.238 is added to read as follows:

Sec.  213.238  Qualified operator.

    (a) Each track owner or railroad conducting rail flaw detection
shall have a documented training program in place and shall identify
the types of rail flaw detection equipment for which each operator has
received training and is qualified.
    (b) A qualified operator shall be trained and shall have written
authorization by the employing track owner or railroad (employer) to:
    (1) Conduct a valid search for internal rail defects utilizing the
specific type(s) of equipment for which he or she is authorized and
qualified to operate;
    (2) Determine that such equipment is performing as intended;
    (3) Interpret equipment responses and institute appropriate action
in accordance with the employer's procedures and instructions; and
    (4) Determine that each valid search for an internal rail defect is
continuous throughout the area inspected and has not been compromised
due to environmental contamination, rail conditions, or equipment
malfunction.
    (c) The operator must have received training in accordance with the
documented training program and a minimum of 160 hours of rail flaw
detection experience under direct supervision of a qualified operator
or

rail flaw detection equipment manufacturer's representative. The
operator must demonstrate proficiency in the rail defect detection
process, including the equipment to be utilized, prior to initial
qualification and authorization by the employer for each type of
equipment.
    (d) Each employer shall reevaluate the qualifications of, and
administer any necessary recurrent training for, the operator as
determined by and in accordance with the employer's documented program.
The reevaluation and recurrent training may consist of a periodic
review of test data submitted by the operator. The reevaluation process
shall require that the employee successfully complete a recorded
examination and demonstrate proficiency to the employer on the specific
equipment type(s) to be operated.
    (e) Each employer of a qualified operator shall maintain written or
electronic records of each qualification in effect. Each record shall
include the name of the employee, the equipment to which the
qualification applies, date of qualification, and date of the most
recent reevaluation, if any.
    (f) Any employee who has demonstrated proficiency in the operation
of rail flaw detection equipment prior to [DATE OF PUBLICATION OF THE
FINAL RULE IN THE Federal Register], is deemed a qualified operator,
regardless of the previous training program under which the employee
was qualified. Such an operator shall be subject to paragraph (d) of
this section.
    (g) Records concerning the qualification of operators, including
copies of equipment[hyphen]specific training programs and materials,
recorded examinations, demonstrated proficiency records, and
authorization records, shall be kept at a location designated by the
employer and available for inspection and copying by FRA during regular
business hours.
    7. Section 213.241 is amended by redesignating paragraphs (d) and
(e) as (f) and (g), by revising paragraph (c), by adding paragraphs (d)
and (e), and by revising newly redesignated paragraphs (f) and (g) to
read as follows:

Sec.  213.241  Inspection records.

* * * * *
    (c) Records of internal rail inspections required by Sec.  213.237
shall specify the--
    (1) Date of inspection;
    (2) Track inspected, including beginning and end points;
    (3) Location and type of defects found under Sec.  213.113;
    (4) Size of defects found under Sec.  213.113, if not removed prior
to the next train movement;
    (5) Initial remedial action taken and the date thereof; and
    (6) Location of any track not tested pursuant to Sec.  213.237(g).
    (d) The track owner shall retain a rail inspection record under
paragraph (c) of this section for at least two years after the
inspection and for one year after initial remedial action is taken.
    (e) The track owner shall maintain records sufficient to
demonstrate the means by which it computes the service failure rate on
all track segments subject to the requirements of Sec.  213.237(a) for
the purpose of determining compliance with the applicable service
failure rate target.
    (f) Each track owner required to keep inspection records under this
section shall make those records available for inspection and copying
by FRA upon request.
    (g) For purposes of complying with the requirements of this
section, a track owner may maintain and transfer records through
electronic transmission, storage, and retrieval provided that--
    (1) The electronic system is designed so that the integrity of each
record is maintained through appropriate levels of security such as
recognition of an electronic signature, or another means, which
uniquely identifies the initiating person as the author of that record.
No two persons shall have the same electronic identity;
    (2) The electronic storage of each record shall be initiated by the
person making the inspection within 24 hours following the completion
of that inspection;
    (3) The electronic system shall ensure that each record cannot be
modified in any way, or replaced, once the record is transmitted and
stored;
    (4) Any amendment to a record shall be electronically stored apart
from the record which it amends. Each amendment to a record shall be
uniquely identified as to the person making the amendment;
    (5) The electronic system shall provide for the maintenance of
inspection records as originally submitted without corruption or loss
of data;
    (6) Paper copies of electronic records and amendments to those
records that may be necessary to document compliance with this part
shall be made available for inspection and copying by FRA at the
locations specified in paragraph (b) of this section; and
    (7) Track inspection records shall be kept available to persons who
performed the inspections and to persons performing subsequent
inspections.

    Issued in Washington, DC, on October 12, 2012.
Karen J. Hedlund,
Deputy Administrator.
[FR Doc. 2012-25620 Filed 10-18-12; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 77, Number 79 (Tuesday, April 24, 2012)]
[Notices]
[Pages 24547-24549]
[FR Doc No: 2012-9771]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66827; File No. SR-ISE-2012-26]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing of Proposed Rule Change To List and Trade Option
Contracts Overlying 10 Shares of a Security

April 18, 2012.
    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 April 9, 2012, International Securities Exchange, LLC (the
``Exchange'' or the ``ISE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the self-
regulatory organization. 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 list and trade option contracts overlying
10 shares of a security (``Mini Options''). The text of the proposed
rule change is available on the Exchange's Internet Web site at http://www.ise.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 self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in sections A, B and C below, of the
most significant aspects of such statements.

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

1. Purpose
    Pursuant to ISE Rule 502, the Exchange currently lists and trades
standardized options contracts on a number of equities and Exchange-
Traded Fund Shares (``ETFs''), each with a unit of trading of 100
shares. The purpose of this proposed rule change is to expand
investors' choices by listing and trading option contracts on a select
number of high-priced and actively traded securities, each with a unit
of trading ten times lower than those of the regular sized option
contracts, or 10 shares. Specifically, the Exchange proposes to adopt
Supplementary Material .12(a) to ISE Rule 504, which states that after
an option class on a stock or Exchange-Traded Fund Share with a 100
share deliverable has been approved for listing and trading on the
Exchange, series of option contracts with a 10 share deliverable on
that stock or Exchange-Traded Fund Share may be listed for all
expirations opened for trading on the Exchange. The Exchange further
proposes that Mini Options may only be listed on stocks and Exchange-
Traded Fund Shares that meet the following criteria, at the time of
listing: (a) The industry average daily options volume over the
previous three calendar months is at least 10,000 contracts, and (b)
the price of the underlying security is at least $150.
    The Exchange notes that as a result of the proposed listing
criteria, only a handful of securities, ones that have significant
options liquidity, will be eligible to have Mini Options listed on
them. Specifically, pursuant to the listing criteria established by the
Exchange for Mini Options, the following securities currently qualify
to have Mini Options listed: Apple, Inc., (AAPL), SPDR Gold Trust
(GLD), Google, Inc. (GOOG), Amazon, Inc. (AMZN), International Business
Machines (IBM), and Priceline.com, Inc. (PCLN). The Exchange believes
that Mini Options will appeal to retail investors who may not currently
be able to participate in the trading of options on such high priced
securities.
    Except for the difference in the deliverable of shares, the
proposed Mini Options would have the same terms and contract
characteristics as regular sized equity and ETF options, including
exercise style. All existing Exchange rules applicable to options on
equities and ETFs would apply to Mini Options, except with respect to
position and exercise limits and hedge exemptions to those position
limits, which would be tailored for the smaller size. Pursuant to
proposed amendments to Rule 412, position limits applicable to the
regular sized option contract will also apply to the Mini Options on
the same underlying security, with 10 Mini Option contracts counting as
one regular

sized contract. Positions in both the regular sized option contract and
Mini Options on the same security will be combined for purposes of
calculating positions. Further, hedge exemptions will apply pursuant to
ISE Rule 413(a), which the Exchange proposes to revise to provide that
10 (as opposed to 100) shares of the underlying security in the
appropriate hedge for Mini Options and to make clear that the hedge
exemptions apply to the position limits set forth in Rule 412(a) and
any Supplementary Material thereto, as well as the position limits set
forth in Rule 412(d).\3\
---------------------------------------------------------------------------

    \3\ ISE Rule 414, Exercise Limits, refers to exercise limits
that correspond to aggregate long positions as described in ISE Rule
412. The position limit established in a given option under ISE Rule
412 is also the exercise limit for such option. Thus, although the
proposed rule change would not amend the text of ISE Rule 414
itself, the proposed amendment to ISE Rule 412 would have a
corresponding effect to the exercise limits established in ISE Rule
414.
---------------------------------------------------------------------------

    The Exchange believes that the proposal to list Mini Options will
not lead to investor confusion. There are two important distinctions
between Mini Options and regular options that are designed to ease the
likelihood of any investor confusion. First, the premium multiplier for
the proposed Mini Options will be 10, rather than 100, to reflect the
smaller unit of trading. To reflect this change, the Exchange proposes
to add Rule 709(c) which notes that bids and offers for an option
contract overlying 10 shares will be expressed in terms of dollars per
1/10th part of the total value of the contract. Thus, an offer of
``.50'' shall represent an offer of $5.00 on an option contract having
a unit of trading consisting of 10 shares. Second, the Exchange intends
to designate Mini Options with different trading symbols than that
designated for the regular sized contract. For example, while the
trading symbol for regular option contracts for Apple, Inc. is AAPL,
the Exchange proposes to adopt 7AAPL as the trading symbol for Mini
Options on that same security.
    The Exchange proposes to add Supplementary Material .12(b) to
reflect that strike prices for Mini Options shall be set at the same
level as for regular options. For example, a call series strike price
to deliver 10 shares of stock at $125 per share has a total deliverable
value of $1250, and the strike price will be set at 125. Further,
pursuant to proposed new Supplementary Material .12(c) to Rule 504, the
Exchange proposes to not permit the listing of additional series of
Mini Options if the underlying is trading at $90 or less to limit the
number of strikes once the underlying is no longer a high priced
security. The Exchange proposes a $90.01 minimum for continued
qualification so that additional series of Mini Options that correspond
to standard strikes may be added even though the underlying has fallen
slightly below the initial qualification standard. In addition, the
underlying security must be trading above $90 for five consecutive days
before the listing of Mini Option contracts in a new expiration month.
This restriction will allow the Exchange to list strikes in Mini
Options without disruption when a new expiration month is added even if
the underlying has had a minor decline in price.
    The same trading rules applicable to existing equity and ETF
options will apply to Mini Options. The Exchange notes that by listing
the same strike price for Mini Options as for regular options, the
Exchange seeks to keep intact the long-standing relationship between
the underlying security and an option strike price thus allowing
investors to intuitively grasp the option's value, i.e., option is in
the money, at the money or out of the money. The Exchange believes that
by not changing anything but the multiplier and the option symbol, as
discussed above, retail investors will be able to grasp the distinction
between regular size option contracts and Mini Options. The Exchange
notes that The Options Clearing Corporation (``OCC'') Symbology is
structured for contracts that have a deliverable of other than 100
shares to be designated with a numeric added to the standard trading
symbol. Further, the Exchange believes that the contract
characteristics of Mini Options are consistent with the terms of the
Options Disclosure Document.
    With regard to the impact of this proposal on system capacity, ISE
has analyzed its capacity and represents that it and the Options Price
Reporting Authority have the necessary systems capacity to handle the
potential additional traffic associated with the listing and trading of
Mini Options. The Exchange has further discussed the proposed listing
and trading of Mini Options with the OCC, which has represented that it
is able to accommodate the proposal.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Securities and Exchange Act of
1934 (``Exchange Act''),\4\ in general, and with Section 6(b)(5) of the
Exchange Act,\5\ in particular, in that the proposal is 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.
Specifically, the Exchange believes that investors would benefit from
the introduction and availability of Mini Options by making options on
high priced securities more readily available and as an investing tool
at more affordable prices, particularly for average retail investors,
who otherwise may not be able to participate in trading options on high
priced securities. As noted above, the proposed rule change intends to
adopt a different trading symbol to distinguish Mini Options from
regular option contracts and therefore, ease any investor confusion as
to the product they are trading. Moreover, the proposed rule change is
designed to protect investors and the public interest by providing
investors with an enhanced tool to reduce risk in high priced
securities. In particular, Mini Options will provide retail customers
who invest in high priced issues in lots of less than 100 shares with a
means of protecting their investments that is currently only available
to those who have positions of 100 shares or more. Further, the
proposed rule change is limited to those securities that meet the
Exchange's proposed listing criteria to ensure that only those
securities that have significant options liquidity and therefore,
customer demand, are selected to have Mini Options listed on them.
---------------------------------------------------------------------------

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

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    Within 45 days of the date of publication of this notice in the
Federal

Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. In particular, the Commission seeks
comment on the following:
    1. NYSE Arca, Inc. recently proposed to allow the listing and
trading of a ``mini'' option product.\6\ The Exchange's proposal would
allow the listing and trading of Mini Options contracts with contract
specifications that differ from the similar product proposed by NYSE
Arca. Due to the differences in contract specifications, these two
similar products, even if on the same underlying security, would not
necessarily be fungible. The Commission requests comment on whether the
listing and trading of two distinct and non-fungible ``mini'' options
products, particularly if on the same underlying security, would create
investor confusion or raise any other issues or concerns for market
participants.
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 66725 (April 3,
2012), 77 FR 21120 (April 9, 2012) (SR-NYSEArca-2012-26).
---------------------------------------------------------------------------

    2. As discussed above, the Exchange's proposal would provide for
contract specifications for Mini Options that include: (i) The strike
prices would be set at the same level for Mini Options as for
corresponding standard contracts; (ii) the premium multiplier would be
10 for Mini Options (rather than 100 as for the standard contract) and
the premium would be expressed in terms of dollars per 1/10th part of
the total value of the contract; and (iii) the Exchange would designate
Mini Options with different trading symbols than the standard contract.
The Commission requests comment regarding the Exchange's proposed
contract methodology.\7\
---------------------------------------------------------------------------

    \7\ For a description of the proposed contract methodology for
the mini option product proposed by NYSE Arca, see id.
---------------------------------------------------------------------------

    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 No. SR-ISE-2012-26 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2012-26. 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
a.m. and 3 p.m. Copies of such 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-ISE-2012-26 and should be
submitted on or before May 15, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
Kevin M. O'Neill,
Deputy Secretary.
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    \8\ 17 CFR 200.30-3(a)(12).
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[FR Doc. 2012-9771 Filed 4-23-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 105 (Tuesday, June 2, 2015)]
[Rules and Regulations]
[Pages 31299-31300]
[FR Doc No: 2015-13329]

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

Food and Drug Administration

21 CFR Part 895

[Docket No. FDA-2015-N-0011]

Banned Devices; General Provisions; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to clarify that the Agency will provide an opportunity for
an informal hearing in connection with a proposed rule to ban a device
with a special effective date. This action is being taken to align the
regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C
Act).

DATES: This rule is effective June 2, 2015.

FOR FURTHER INFORMATION CONTACT: Ian Ostermiller, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4432, Silver Spring, MD 20993-0002, 301-
796-5678.

SUPPLEMENTARY INFORMATION: FDA is correcting an error in the
regulations that set forth the procedures for banning a medical device
using a special effective date (Sec.  895.30 (21 CFR 895.30)).
Specifically, the Agency is restoring a phrase that was incorrectly
deleted from Sec.  895.30(c). The regulations are being amended to
ensure clarity and consistency with the requirements of the FD&C Act
(21 U.S.C. 321 et seq.).
    In this case, the regulations became inconsistent after the Safe
Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629) amended the FD&C
Act. Prior to the SMDA, the FD&C Act required the Secretary of Health
and Human Services to afford an opportunity for informal hearings about
any proposed rule to ban a medical device, regardless of effective
date. One of the SMDA's provisions removed the requirement that FDA
provide an opportunity for an informal hearing when FDA does not
establish a special effective date for a proposed ban.\1\ However, the
SMDA did not eliminate the informal hearing provision for a proposed
ban issued with a special effective date. Thus, section 516(b) of the
FD&C Act continues to require that FDA ``provide reasonable opportunity
for an informal hearing'' on a proposed ban with a special effective
date (21 U.S.C. 360f(b)).
---------------------------------------------------------------------------

    \1\ Specifically, the SMDA deleted the then-last sentence of
section 516(a). See Pub. L. 101-629, section 18(d)(2) (``Section
516(a) (21 U.S.C. 360f(a)) is amended . . . by striking out the last
sentence.''); 21 U.S.C. 360f(a) (1989) (stating, in the last
sentence, ``The Secretary shall afford all interested persons
opportunity for an informal hearing on a regulation proposed under
this subsection.'').
---------------------------------------------------------------------------

    On December 10, 1992 (57 FR 58400), FDA published a final rule
implementing the SMDA. The final rule of 1992 correctly amended 21 CFR
895.21(d), which covers the procedures for issuing a ban without a
special effective date, by removing the requirement that FDA provide an
opportunity for an informal hearing when there is no special effective
date.\2\ However, the final rule incorrectly removed the same phrase
from Sec.  895.30,

which covers the procedures for issuing a ban with a special effective
date. This rule corrects Sec.  895.30(c) by restoring the incorrectly
removed phrase.
---------------------------------------------------------------------------

    \2\ Although the hearing provision was validly removed from
Sec.  895.21(d)(8) in 1992, the removed language erroneously
reappeared in the Code of Federal Regulations starting in 1994. On
March 5, 2015 (80 FR 11865), the Office of the Federal Register
published a correction document fixing this publication error.
---------------------------------------------------------------------------

    FDA finds good cause for issuing this amendment as a final rule
without notice and comment because this amendment only corrects the
implementing regulation to restate the statute (5 U.S.C. 553(b)(B)).
``[W]hen regulations merely restate the statute they implement, notice-
and-comment procedures are unnecessary.'' Gray Panthers Advocacy
Committee v. Sullivan, 936 F.2d 1284, 1291 (D.C. Cir. 1991); see also
Komjathy v. Nat. Trans. Safety Bd., 832 F.2d 1294, 1296 (D.C. Cir.
1987) (when a rule ``does no more than repeat, virtually verbatim, the
statutory grant of authority,'' notice-and-comment procedures are not
required). This amendment to Sec.  895.30(c) merely incorporates
applicable requirements of the FD&C Act, making notice-and-comment
procedures unnecessary in this case. Therefore, publication of this
document constitutes final action on this change under the
Administrative Procedure Act (APA) (5 U.S.C. 553).
    In addition, FDA finds good cause for this amendment to become
effective on the date of publication of this action. The APA allows an
effective date less than 30 days after publication as ``provided by the
agency for good cause found and published with the rule'' (5 U.S.C.
553(d)(3)). A delayed effective date is unnecessary in this case
because the amendment to Sec.  895.30 does not impose any new
regulatory requirements on affected parties. As a result, affected
parties do not need time to prepare before the rule takes effect.
Therefore, FDA finds good cause for this correction to become effective
on the date of publication of this action.

List of Subjects in 21 CFR Part 895

    Administrative practice and procedure, Labeling, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
895 is amended as follows:

PART 895--BANNED DEVICES

0
1. The authority citation for 21 CFR part 895 continues to read as
follows:

    Authority:  21 U.S.C. 352, 360f, 360h, 360i, 371.

0
2. Amend Sec.  895.30 by revising paragraph (c) to read as follows:

Sec.  895.30  Special effective date.

* * * * *
    (c) If the Commissioner makes a proposed regulation effective in
accordance with this section, the Commissioner will, as expeditiously
as possible, give interested persons prompt notice of this action in
the Federal Register and will provide an opportunity for an informal
hearing in accordance with part 16 of this chapter.
* * * * *

    Dated: May 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13329 Filed 6-1-15; 8:45 am]
 BILLING CODE 4164-01-P