[Federal Register: June 24, 2010 (Volume 75, Number 121)]
[Notices]
[Page 36092-36097]
[DOCID:fr24jn10-48]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0273]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices: Current Good Manufacturing Practice
Quality System Regulations

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 recordkeeping requirements
related to the medical devices current good manufacturing practice
(CGMP) quality system (QS) regulation (CGMP/QS regulation).

DATES: Submit either electronic or written comments on the collection
of information by August 23, 2010.

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

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20857,<PHONE_NUMBER> email:
<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.

Medical Devices: Current Good Manufacturing Practice Quality System
Regulations--21 CFR Part 820 (OMB Control Number 0910-0073)--Extension

    Under section 520(f) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360j(f)), the Secretary of the Department of
Health and Human Services has the authority to prescribe regulations
requiring that the methods used in, and the facilities and controls
used for, the manufacture, pre-production design validation (including
a process to assess the performance of a device but not including an
evaluation of the safety and effectiveness of a device), packing,
storage, and installation of a device conform to CGMP, as described in
such regulations, to assure that the device will be safe and effective
and otherwise in compliance with the act.
    The CGMP/QS regulation implementing authority provided by this
statutory provision is found under part 820 (21 CFR part 820) and sets
forth basic CGMP requirements governing the design, manufacture,
packing, labeling, storage, installation, and servicing of all finished
medical devices intended for human use. The authority for this
regulation is covered under sections 501, 502, 510, 513, 514, 515, 518,
519, 520, 522, 701, 704, 801, and 803 of the act (21 U.S.C. 351, 352,
360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, and 383).
The CGMP/QS regulation includes requirements for purchasing and service
controls, clarifies recordkeeping requirements for device failure and
complaint investigations, clarifies requirements for verifying/
validating production processes and process or product changes, and
clarifies requirements for product acceptance activities quality data
evaluations and corrections of nonconforming product/quality problems.
    Requirements are compatible with specifications in the
international standards ``ISO 9001: Quality Systems Model for Quality
Assurance in Design/Development, Production, Installation, and
Servicing.'' The CGMP/QS information collections will assist FDA
inspections of manufacturers for compliance with QS requirements
encompassing design, production, installation, and servicing processes.
    Section 820.20(a) through (e) requires management with executive
responsibility to establish, maintain, and/or review the following
topics: (1) The quality policy, (2) the organizational structure, (3)
the quality plan, and (4) the quality system procedures of the
organization.
    Section 820.22 requires the conduct and documentation of QS audits
and reaudits.
    Section 820.25(b) requires the establishment of procedures to
identify training needs and documentation of such training.
    Section 820.30(a)(1) and (b) through (j), requires in respective
order, the establishment, maintenance, and/or documentation of the
following topics: (1) Procedures to control design of class III and
class II devices and certain class I devices as listed therein; (2)
plans for design and development activities and updates; (3) procedures
identifying, documenting, and approving design input requirements; (4)
procedures defining design output, including acceptance criteria, and
documentation of approved records; (5) procedures for formal review of
design results and documentation of results in the design history file
(DHF); (6) procedures for verifying device design and documentation of
results and approvals in the DHF; (7) procedures for validating device
design, including documentation of results in the DHF; (8) procedures
for translating device design into production specifications; (9)
procedures for documenting, verifying, and validating approved design
changes before implementation of changes; and (10) the records and
references constituting the DHF for each type of device.
    Section 820.40 requires manufacturers to establish and maintain
procedures controlling approval and distribution of required documents
and document changes.
    Section 820.40(a) and (b) requires the establishment and
maintenance of procedures for the review, approval, issuance, and
documentation of required records (documents) and changes to those
records.
    Section 820.50(a)(1), (a)(2), (a)(3), and (b) requires the
establishment and maintenance of procedures and requirements to ensure
service and product quality, records of acceptable suppliers, and
purchasing data

describing specified requirements for products and services.
    Sections 820.60 and 820.65 require, respectively, the establishment
and maintenance of procedures for identifying all products from receipt
to distribution and for using control numbers to track surgical
implants and life-sustaining or supporting devices and their
components.
    Section 820.70(a)(1) through (a)(5), (b) through (e), (g)(1)
through (g)(3), (h), and (i) requires the establishment, maintenance,
and/or documentation of the following topics: (1) Process control
procedures; (2) procedures for verifying or validating changes to
specification, method, process, or procedure; (3) procedures to control
environmental conditions and inspection result records; (4)
requirements for personnel hygiene; (5) procedures for preventing
contamination of equipment and products; (6) equipment adjustment,
cleaning, and maintenance schedules; (7) equipment inspection records;
(8) equipment tolerance postings, procedures for utilizing
manufacturing materials expected to have an adverse effect on product
quality; and (9) validation protocols and validation records for
computer software and software changes.
    Sections 820.72(a), (b)(1), and (b)(2) and 820.75(a) through (c)
require, respectively, the establishment, maintenance, and/or
documentation of the following topics: (1) Equipment calibration and
inspection procedures; (2) national, international or in-house
calibration standards; (3) records that identify calibrated equipment
and next calibration dates; (4) validation procedures and validation
results for processes not verifiable by inspections and tests; (5)
procedures for keeping validated processes within specified limits; (6)
records for monitoring and controlling validated processes; and (7)
records of the results of revalidation where necessitated by process
changes or deviations.
    Sections 820.80(a) through (e) and 820.86, respectively, require
the establishment, maintenance, and/or documentation of the following
topics: (1) Procedures for incoming acceptance by inspection, test, or
other verification; (2) procedures for ensuring that in-process
products meet specified requirements and the control of product until
inspection and tests are completed; (3) procedures for, and records
that show, incoming acceptance or rejection is conducted by
inspections, tests or other verifications; (4) procedures for, and
records that show, finished devices meet acceptance criteria and are
not distributed until device master record (DMR) activities are
completed; (5) records in the device history record (DHR) showing
acceptance dates, results, and equipment used; and (6) the acceptance/
rejection identification of products from receipt to installation and
servicing.
    Sections 820.90(a), (b)(1), and (b)(2) and 820.100 require,
respectively, the establishment, maintenance and/or documentation of
the following topics: (1) Procedures for identifying, recording,
evaluating, and disposing of nonconforming product; (2) procedures for
reviewing and recording concessions made for, and disposition of,
nonconforming product; (3) procedures for reworking products,
evaluating possible adverse rework effect and recording results in the
DHR; (4) procedures and requirements for corrective and preventive
actions, including analysis, investigation, identification and review
of data, records, causes, and results; and (5) records for all
corrective and preventive action activities.
    Section 820.100(a)(1) through (a)(7) states that procedures and
requirements shall be established and maintained for corrective/
preventive actions, including the following: (1) Analysis of data from
process, work, quality, servicing records; investigation of
nonconformance causes; (2) identification of corrections and their
effectiveness; (3) recording of changes made; and (4) appropriate
distribution and managerial review of corrective and preventive action
information.
    Section 820.120 states that manufacturers shall establish/maintain
procedures to control labeling storage/application; and examination/
release for storage and use, and document those procedures.
    Sections 820.120(b) and (d), 820.130, 820.140, 820.150(a) and (b),
820.160(a) and (b), and 820.170(a) and (b), respectively, require the
establishment, maintenance, and/or documentation of following topics:
(1) Procedures for controlling and recording the storage, examination,
release, and use of labeling; (2) the filing of labels/labeling used in
the DHR; (3) procedures for controlling product storage areas and
receipt/dispatch authorizations; (4) procedures controlling the release
of products for distribution; (5) distribution records that identify
consignee, product, date, and control numbers; and (6) instructions,
inspection and test procedures that are made available, and the
recording of results for devices requiring installation.
    Sections 820.180(b) and (c), 820.181(a) through (e), 820.184(a)
through (f), and 820.186 require, respectively, the maintenance of
records that are: (1) Retained at prescribed site(s), made readily
available and accessible to FDA and retained for the device's life
expectancy or for 2 years; (2) contained or referenced in a DMR
consisting of device, process, quality assurance, packaging and
labeling, and installation, maintenance, and servicing specifications
and procedures; (3) contained in a DHR and demonstrate the manufacture
of each unit, lot, or batch of product in conformance with DMR and
regulatory requirements, include manufacturing and distribution dates,
quantities, acceptance documents, labels and labeling, control numbers;
and (4) contained in a quality system record (QSR), consisting of
references, documents, procedures, and activities not specific to
particular devices.
    Sections 820.198(a) through (c) and 820.200(a) through (d),
respectively, require the establishment, maintenance, and/or
documentation of the following topics: (1) Complaint files and
procedures for receiving, reviewing and evaluating complaints; (2)
complaint investigation records identifying the device, complainant,
and relationship of the device to the incident; (3) complaint records
that are reasonably accessible to the manufacturing site or at
prescribed sites; (4) procedures for performing and verifying that
device servicing requirements are met and that service reports
involving complaints are processed as complaints; and (5) service
reports that record the device, service activity, and test and
inspection data.
    Section 820.250 requires the establishment and maintenance of
procedures to identify valid statistical techniques necessary to verify
process and product acceptability; and sampling plans, when used, which
are written and based on valid statistical rationale; and procedures
for ensuring adequate sampling methods. The CGMP/QS regulation amends
and revises the CGMP requirements for medical devices set out under
part 820. The regulation adds design and purchasing controls; modifies
previous critical device requirements; revises previous validation and
other requirements; and harmonizes device CGMP requirements with QS
specifications in the international standard ``ISO 9001: Quality
Systems Model for Quality Assurance in Design/Development, Production,
Installation, and Servicing.'' The rule does not apply to manufacturers
of components or parts of finished devices, nor to manufacturers of
human blood and blood components subject to 21 CFR part 606. With
respect to devices classified in class I, design control requirements
apply only to class

I devices listed in Sec.  820.30(a)(2) of the regulation. The rule
imposes burden upon: (1) Finished device manufacturer firms, which are
subject to all recordkeeping requirements; (2) finished device contract
manufacturers, specification developers; and (3) repacker, relabelers,
and contract sterilizer firms, which are subject only to requirements
applicable to their activities. In addition, remanufacturers of
hospital single-use devices (SUDs) will now be considered to have the
same requirements as manufacturers in regard to this regulation. The
establishment, maintenance and/or documentation of procedures, records,
and data required by this regulation will assist FDA in determining
whether firms are in compliance with CGMP requirements, which are
intended to ensure that devices meet their design, production,
labeling, installation, and servicing specifications and, thus are
safe, effective and suitable for their intended purpose. In particular,
compliance with CGMP design control requirements should decrease the
number of design-related device failures that have resulted in deaths
and serious injuries.
    The CGMP/QS regulation applies to approximately 8,924 respondents.
These recordkeepers consist of 8,945 original respondents and an
estimated 18 hospitals that remanufacture or reuse SUDs. They include
manufacturers, subject to all requirements and contract manufacturers,
specification developers, repackers, relabelers, and contract
sterilizers, subject only to requirements applicable to their
activities. Hospital remanufacturers of SUDs are now defined to be
manufacturers under guidelines issued by FDA's Center for Devices and
Radiological Health (CDRH), Office of Surveillance and Biometrics.
Respondents to this collection have no reporting activities, but must
make required records available for review or copying during FDA
inspection. The regulation contains additional recordkeeping
requirements in such areas as design control, purchasing, installation,
and information relating to the remanufacture of SUDs. The estimates
for this burden are derived from those incremental tasks that were
determined when the new CGMP/QS regulation became final as well as
those carryover requirements. The carryover requirements are based on
decisions made by the agency on July 16, 1992, under OMB Control Number
0910-0073, which still provides valid base line data.
    FDA estimates the burden for this collection of information as
follows:

                                                   Table 1.--Estimated Annual Recordkeeping Burden\1\
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                                                                                Total Operating
             21 CFR Section                    No. of       Annual Frequency per    Total Annual        Hours Per     and  Maintenance     Total Hours
                                            Recordkeepers       Recordkeeping          Records           Record             Costs
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820.20(a)                                            8,924                     1             8,924                 7  ................            62,468
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820.20(b)                                            8,924                     1             8,924                 4  ................            35,696
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820.20(c)                                            8,924                     1             8,924                 6  ................            53,544
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820.20(d)                                            8,924                     1             8,924                10  ................            89,240
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820.20(e)                                            8,924                     1             8,924                10  ................            89,240
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820.22                                               8,924                     1             8,924                33  ................           294,492
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820.25(b)                                            8,924                     1             8,924                13  ................           116,012
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820.30(a)(1)                                         8,924                     1             8,924                 2  ................            17,848
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820.30(b)                                            8,924                     1             8,924                 6  ................            53,544
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820.30(c)                                            8,924                     1             8,924                 2  ................            17,848
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820.30(d)                                            8,924                     1             8,924                 2  ................            17,848
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820.30(e)                                            8,924                     1             8,924                23  ................           205,252
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820.30(f)                                            8,924                     1             8,924                37  ................           330,188
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820.30(g)                                            8,924                     1             8,924                37  ................           330,188
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820.30(h)                                            8,924                     1             8,924                 3  ................            26,772
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820.30(i)                                            8,924                     1             8,924                17  ................           151,708
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820.30(j)                                            8,924                     1             8,924                 3  ................            26,772
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820.40                                               8,924                     1             8,924                 9  ................            80,316
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820.40(a) and (b)                                    8,924                     1             8,924                 2  ................            17,848
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820.50(a)(1) through (a)(3)                          8,924                     1             8,924                22         1,300,805           196,328
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820.50(b)                                            8,924                     1             8,924                 6  ................            53,544
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820.6                                                8,924                     1             8,924                 1  ................             8,924
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820.65                                               8,924                     1             8,924                 1  ................             8,924
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820.70(a)(1) through (a)(5)                          8,924                     1             8,924                 2  ................            17,848
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820.70(b) and (c)                                    8,924                     1             8,924                 2  ................            17,848
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820.70(d)                                            8,924                     1             8,924                 3  ................            26,772
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820.70(e)                                            8,924                     1             8,924                 2  ................            17,848
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820.70(g)(1) through (g)(3)                          8,924                     1             8,924                 1  ................             8,924
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820.70(h)                                            8,924                     1             8,924                 2  ................            17,848
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820.70(i)                                            8,924                     1             8,924                 8  ................            71,392
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820.72(a)                                            8,924                     1             8,924                 5  ................            44,620
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820.72(b)(1) and (b)(2)                              8,924                     1             8,924                 1  ................             8,924
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820.75(a)                                            8,924                     1             8,924                 3  ................            26,772
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820.75(b)                                            8,924                     1             8,924                 1  ................             8,924
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820.75(c)                                            8,924                     1             8,924                 1  ................             8,924
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820.80(a) through (e)                                8,924                     1             8,924                 5  ................            44,620
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820.86                                               8,924                     1             8,924                 1  ................             8,924
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820.90(a)                                            8,924                     1             8,924                 5  ................            44,620
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820.90(b)(1) and (b)(2)                              8,924                     1             8,924                 5  ................            44,620
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820.100(a)(1) through (a)(7)                         8,924                     1             8,924                12  ................           107,088
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820.100(b)                                           8,924                     1             8,924                 1  ................             8,924
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820.120(b)                                           8,924                     1             8,924                 1  ................             8,924
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820.120(d)                                           8,924                     1             8,924                 1  ................             8,924
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820.130                                              8,924                     1             8,924                 1  ................             8,924
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820.140                                              8,924                     1             8,924                 6  ................            53,544
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820.150(a) and (b)                                   8,924                     1             8,924                 6  ................            53,544
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820.160(a) and (b)                                   8,924                     1             8,924                 1  ................             8,924
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820.170(a) and (b)                                   8,924                     1             8,924                 2  ................            17,848
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820.180(b) and (c)                                   8,924                     1             8,924                 2  ................            17,848
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820.181(a) through (e)                               8,924                     1             8,924                 1  ................             8,924
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820.184(a) through (f)                               8,924                     1             8,924                 1  ................             8,924
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820.186                                              8,924                     1             8,924                 1  ................             8,924
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820.198(a) through (c)                               8,924                     1             8,924                 5  ................            44,620
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820.200(a) and (d)                                   8,924                     1             8,924                 3  ................            26,772
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820.25                                               8,924                     1             8,924                 1  ................             8,924
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Total                                     ................  ....................  ................  ................         1,300,805         3,105,552
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\1\ There are no capital costs associated with this collection of information.

Explanation of Recordkeeping Burden Estimate

    FDA estimates respondents will have a total annual recordkeeping
burden of approximately 3,105,552 hours. This figure also consists of
approximately 143,052 hours spent on a startup basis by 734 new firms.
    Burden (labor) hour and cost estimates were originally developed
under FDA contract by Eastern Research Group, Inc. (ERG) in 1996 when
the CGMP/QS regulation became final. Additional factors considered in
deriving estimates included the following:
     Establishment type: Query has been made of CDRH's
registration/listing data bank and the current count was 7,748 domestic
firms subject to CGMPs. It was also calculated that each year, the
number of new domestic firms subject to CGMPs is 734. The average
amount of firms therefore subject to CGMPs over the 3 years is
therefore 8,924 and this figure has been used to calculate the total
burden. Because the total number of registered firms is not static, the
number of respondents will fluctuate from year to year resulting in
slight changes to the overall burden.
     During the last report it was estimated that this number
was 8,963. When the last set of numbers was calculated, FDA was still
using a paper based system to register and list firms. On October 1,
2007, FDA switched to an electronic system for registration and
listing. Also at that time the Food and Drug Administration Amendments
Act of 2007 instituted an establishment registration fee for some types
of facilities. FDA believes that during the FY 2008 annual registration
cycle, establishments that had previously registered but were not
required to do so, removed themselves from inventory of active
establishments. FDA believes that the current figures reported by the
electronic system more accurately reflect the inventory of registered
establishments.
     Potentially affected establishments: Except for
manufacturers, not every type of firm is subject to every CGMP/QS
requirement. For example, all are subject to Quality Policy (Sec.
820.20(a)), Document Control (Sec.  820.40), and other requirements,
whereas only manufacturers and specification developers are subject to
Subpart C, Design Controls. The type of firm subject to each
requirement was identified by the ERG.
     FDA estimated the burden hours (and costs) for the
previous CGMP regulation in 1992. That estimate was submitted to OMB on
May 4, 1992, under OMB Paperwork Reduction Act Control Number 0910-
0073. It was approved by OMB on July 16, 1992, and expired on June 30,
1995. The methodology used is different than that used by ERG in
estimating incremental tasks when the new CGMP/QS became final rule.
Nevertheless, the agency believes its 1992 estimate adequately
represents labor hours (and costs) needed to comply with previous CGMP
requirements carried over into the new CGMP/QS regulation. The 1992
estimate used 9,289 respondents (rather than 8,924 respondents), which
compensates for differences in methodology.

    Dated: June 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-15338 Filed 6-23-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 85, Number 235 (Monday, December 7, 2020)]
[Notices]
[Pages 78889-78890]
[FR Doc No: 2020-26892]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: 2:00 p.m. on Wednesday, December 9, 2020. PLACE: The
meeting will be held via remote means and/or at the Commission's
headquarters, 100 F Street NE, Washington, DC 20549.

STATUS: This meeting will be closed to the public.

MATTERS TO BE CONSIDERED: Commissioners, Counsel to the Commissioners,
the Secretary to the Commission, and recording secretaries will attend
the closed meeting. Certain staff members who have an interest in the
matters also may be present.
    In the event that the time, date, or location of this meeting
changes, an announcement of the change, along with the new time, date,
and/or place of the meeting will be posted on the Commission's website
at https://www.sec.gov.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10),
permit consideration of the scheduled matters at the closed meeting.
    The subject matter of the closed meeting will consist of the
following topic:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;

    Resolution of litigation claims; and
    Other matters relating to enforcement proceedings; and
    Disclosure of non-public information.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting agenda items that may consist of
adjudicatory, examination, litigation, or regulatory matters.

CONTACT PERSON FOR MORE INFORMATION: For further information; please
contact Vanessa A. Countryman from the Office of the Secretary at (202)
551-5400.

     Dated: December 2, 2020.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2020-26892 Filed 12-3-20; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 156 (Monday, August 13, 2018)]
[Rules and Regulations]
[Pages 39884-39886]
[FR Doc No: 2018-17262]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0718]
RIN 1625-AA00

Safety Zone; Allegheny River, Miles 43.5 to 45.5, Kittanning, PA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
all navigable waters of the Allegheny River, extending the entire width
of the river, from mile marker (MM) 43.5 to MM 45.5. This safety zone
is necessary to protect persons, property, and the marine environment
from potential hazards associated with a boat race. Entry of persons or
vessels into this zone is prohibited unless authorized by the Captain
of the Port Marine Safety Unit Pittsburgh or a designated
representative.

DATES: This rule is effective each day from 9 a.m. to 8 p.m. from
August 17, 2018, through August 19, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2018-0718 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Charles Morris, Marine Safety Unit
Pittsburgh, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Marine Safety Unit Pittsburgh
DHS Department of Homeland Security
FR Federal Register
MM Mile marker
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that
good cause exists for not publishing a notice of proposed rulemaking
(NPRM) with respect to this rule because it is impracticable. This
safety zone must be established by August 17, 2018 and we lack
sufficient time to provide a reasonable comment period and then
consider those comments before issuing this rule. The NPRM process
would delay the establishment of the safety zone until after the date
of the boat race and compromise public safety.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying this rule would be
contrary to the public interest because immediate action is necessary
to respond to the potential safety hazards associated with this boat
race.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Marine Safety Unit Pittsburgh (COTP) has
determined that potential hazards associated with this boat race will
be a safety hazard for anyone within a two-mile stretch of the
Allegheny River. The rule is needed to protect persons, property, and
the marine environment in the navigable waters within the safety zone
before, during, and after the boat race.

IV. Discussion of the Rule

    This rule establishes a safety zone from 9 a.m. on August 17, 2018
through 8 p.m. on August 19, 2018. The safety zone will be enforced
each day during the effective period from 9 a.m. through 8 p.m. The
safety zone will cover all navigable waters of the Allegheny River,
extending the entire width of the river, from mile marker (MM) 43.5 to
MM 45.5. The duration of the zone is intended to protect personnel,
vessels, and the marine environment in these navigable waters before,
during, and after the boat race. No vessel or person will be permitted
to enter the safety zone without obtaining permission from the COTP or
a designated representative. A designated representative is a
commissioned, warrant, or petty officer of the U.S. Coast Guard
assigned to units under the operational control of USCG Marine Safety
Unit Pittsburgh. Persons and vessels seeking entry into this safety
zone must request permission from the COTP or a designated
representative.

They may be contacted on VHF-FM Channel 16 or by telephone at (412)
221-0807. Persons and vessels permitted to enter this safety zone must
transit at their slowest safe speed and comply with all lawful
instructions of the COTP or a designated representative. The COTP or a
designated representative will inform the public of the enforcement
period for the safety zone as well as any changes in the schedule
through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners
(LNMs), and/or Marine Safety Information Broadcasts (MSIBs) as
appropriate.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size, time,
duration, and location of the safety zone. This safety zone encompasses
a two-mile stretch of the Allegheny River for eleven hours on each of
three days. Moreover, the Coast Guard will issue a Broadcast Notice to
Mariners (BNMs) via VHF-FM marine channel 16 about the zone, and the
rule allows vessels to seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
temporary safety zone may be small entities, for the reasons stated in
section V.A above, this rule will not have a significant economic
impact on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Commandant Instruction M16475.1D, which guide the
Coast Guard in complying with the National Environmental Policy Act of
1969 (42 U.S.C. 4321-4370f), and have determined that this action is
one of a category of actions that do not individually or cumulatively
have a significant effect on the human environment. This rule involves
a safety zone lasting eleven hours that will prohibit entry on a two-
mile stretch of the Allegheny River on each of three days. It is
categorically excluded from further review under paragraph L60(a) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A
Record of Environmental Consideration supporting this determination is
available in the docket where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T08-0718 to read as follows:

Sec.  165.T08-0718   Safety Zone; Allegheny River, miles 43.5 to 45.5,
Kittanning, PA.

    (a) Location. The following area is a safety zone: All navigable
waters of the Allegheny River, extending the entire width of the river,
from mile marker (MM) 43.5 to MM 45.5.
    (b) Effective period. This section is effective each day from 9
a.m. through 8 p.m. August 17, 2018 through August 19, 2018.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry into this zone is prohibited unless authorized by
the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a
designated representative. A designated representative is a
commissioned, warrant, or petty officer of the U.S. Coast Guard
assigned to units under the operational control of USCG Marine Safety
Unit Pittsburgh.
    (2) Persons and vessels seeking entry into this safety zone must
request permission from the COTP or a designated representative. They
may be contacted on VHF-FM Channel 16 or by telephone at (412) 221-
0807.
    (3) Persons and vessels permitted to enter this safety zone must
transit at their slowest safe speed and comply with all lawful
instructions of the COTP or a designated representative.
    (e) Informational broadcasts. The COTP or a designated
representative will inform the public of the enforcement period for the
safety zone as well as any changes in the schedule through Broadcast
Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or
Marine Safety Information Broadcasts (MSIBs) as appropriate.

    Dated: August 6, 2018.
F.M. Smith,
Lieutenant Commander, U.S. Coast Guard, Acting Captain of the Port
Marine Safety Unit Pittsburgh.
[FR Doc. 2018-17262 Filed 8-10-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 60 (Tuesday, March 29, 2011)]
[Notices]
[Pages 17481-17483]
[FR Doc No: 2011-7258]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2011-0024]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of applications for exemptions; request for comments.

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

SUMMARY: FMCSA announces receipt of applications from 16 individuals
for exemption from the vision requirement in the Federal Motor Carrier
Safety Regulations. If granted, the exemptions would enable these
individuals to qualify as drivers of commercial motor vehicles (CMVs)
in interstate commerce without meeting the Federal vision standard.

DATES: Comments must be received on or before April 28, 2011.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2011-0024 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket numbers for this notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the FDMS published in

the Federal Register on January 17, 2008 (73 FR 3316), or you may visit
http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue, SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m., Monday
through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal Motor Carrier Safety Regulations for a 2-year period
if it finds ``such exemption would likely achieve a level of safety
that is equivalent to, or greater than, the level that would be
achieved absent such exemption.'' FMCSA can renew exemptions at the end
of each 2-year period. The 16 individuals listed in this notice have
each requested such an exemption from the vision requirement in 49 CFR
391.41(b)(10), which applies to drivers of CMVs in interstate commerce.
Accordingly, the Agency will evaluate the qualifications of each
applicant to determine whether granting an exemption will achieve the
required level of safety mandated by statute.

Qualifications of Applicants

David W. Bennett

    Mr. Bennett, age 48, has had amblyopia in his left eye since
childhood. The best corrected visual acuity in his right eye is 20/20
and in his left eye, 20/60. Following an examination in 2011, his
ophthalmologist noted, ``Mr. Bennett has sufficient vision to perform
the driving task of driving a commercial vehicle.'' Mr. Bennett
reported that he has driven straight trucks for 5 years, accumulating
218,750 miles and tractor-trailer combinations for 13 years
accumulating 1.4 million miles. He holds a Class A Commercial Driver's
License (CDL) from North Carolina. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Toby L. Carson

    Mr. Carson, 43, has a history of congenital cataracts. The best
corrected visual acuity in his right eye is 20/150 and in his left eye,
20/20. Following an examination in 2010, his ophthalmologist noted,
``Toby Carson has sufficient vision to perform the driving tasks
required to operate a commercial vehicle.'' Mr. Carson reported that he
has driven straight trucks for 15 years, accumulating 200,000 miles and
tractor-trailer combinations for 10 years accumulating 300,000 miles.
He holds a Class A CDL from Tennessee. His driving record for the last
3 years shows no crashes and no convictions for moving violations in a
CMV.

Fredrick M. DeHoff, Jr.

    Mr. Dehoff, 53, has had amblyopia in his right eye since childhood.
The best corrected visual acuity in his right eye is 20/50 and in his
left eye, 20/20. Following an examination in 2010, his optometrist
noted, ``Fredrick, by vision examination, appears to have sufficient
vision to operate a commercial vehicle.'' Mr. DeHoff reported that he
has driven straight trucks for 15 years, accumulating 187,500 miles. He
holds a Class A CDL from Indiana. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Raul Donozo

    Mr. Donozo, 35, has had loss of vision in his left eye since 1998.
The best corrected visual acuity in his right eye is 20/20. Following
an examination in 2011, his ophthalmologist noted, ``In my opinion, the
patient has sufficient vision for driving including commercial
vehicles.'' Mr. Donozo reported that he has driven straight trucks for
8 years, accumulating 417,600 miles. He holds a Class C operator's
license from California. His driving record for the last 3 years shows
no crashes and no convictions for moving violations in a CMV.

Rick A. Ervin

    Mr. Ervin, 39, has had amblyopia in his left eye since childhood.
The best corrected visual acuity in his right eye is 20/20 and in his
left eye, hand motion vision. Following an examination in 2011, his
optometrist noted, ``Mr. Erwin's left eye amblyopia is of long-standing
and he has adapted well to his condition, and in my medical opinion,
has sufficient vision to perform the driving tasks to operate a
commercial vehicle.'' Mr. Ervin reported that he has driven straight
trucks 17 years, accumulating 510,000 miles. He holds a Class B CDL
from New Mexico. His driving record for the last 3 years shows no
crashes and no convictions for moving violations in a CMV.

Clifford D. Johnson

    Mr. Johnson, 44, has ocular trauma in his left eye sustained 25
years ago. The best corrected visual acuity in his right eye is 20/20
and in his left eye, no light perception. Following an examination in
2010, his optometrist noted, ``In my opinion Mr. Johnson has sufficient
vision to perform the driving tasks required to operate a commercial
vehicle.'' Mr. Johnson reported that he has driven straight trucks 25
years, accumulating 700,000 miles and tractor-trailer combinations for
15 years accumulating 495,000 miles. He holds a Class A CDL from
Virginia. His driving record for the last 3 years shows one crash for
which he was cited and no convictions for moving violations in a CMV.

Dionicio Mendoza

    Mr. Mendoza, 34, has a prosthetic right eye due to a traumatic
injury that occurred at age 2. The visual acuity in his left eye is 20/
20. Following an examination in 2010, his optometrist noted, ``After a
full eye health examination, this patient has sufficient vision to
perform the driving tasks required to operate a commercial vehicle.''
    Mr. Mendoza reported that he has driven tractor-trailer
combinations for 5 years, accumulating 224,500 miles. He holds a Class
A CDL from Texas. His driving record for the last 3 years shows no
crashes and no convictions for moving violations in a CMV.

David Kibble

    Mr. Kibble, 48, has had a disciform central macular scar of his
right eye due to a traumatic injury to his right eye that occurred 30
years ago. The best corrected visual acuity in his right eye is 20/400
and in his left eye, 20/20. Following an examination in 2010, his
optometrist noted, ``He has sufficient vision to perform driving tasks
to operate a commercial vehicle.'' Mr. Kibble reported that he has
driven straight trucks 30 years, accumulating 450,000 miles. He holds a
Class C operator's license from Pennsylvania. His driving record for
the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Raymond J. Paiz

    Mr. Paiz, 60, has monocular vision due to a traumatic injury to his
left eye that occurred 30 years ago. The visual acuity in his right eye
is 20/20. Following an examination in 2010, his optometrist noted, ``In
my optometric opinion, Mr. Paiz has sufficient vision and peripheral
vision to enable him to perform the driving tasks necessary to operate
a commercial vehicle.'' Mr. Paiz reported that he has driven straight
trucks 35 years, accumulating 1.8

million miles and tractor-trailer combinations for 35 years
accumulating 1.8 million miles. He holds a Class A CDL from California.
His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

Tyler R. Peebles

    Mr. Peebles, 23, has retinal detachment and traumatic cataract in
his left eye due to a traumatic injury to his left eye. The best
corrected visual acuity in his right eye is 20/20 and in his left eye,
20/50. Following an examination in 2010, his optometrist noted, ``I
feel Mr. Peebles has adequate vision to perform the driving tasks
required to operate a commercial vehicle.'' Mr. Peebles reported that
he has driven straight trucks for 3 years, accumulating 61,500 miles
and tractor-trailer combinations for 3 years accumulating 292,500
miles. He holds a Class A CDL from Ohio. His driving record for the
last 3 years shows no crashes but two convictions for speeding in a
CMV. In the first incident, he exceeded the speed limit by 10 miles per
hour (MPH), in the second incident, he exceeded the speed limit by 8
MPH. He has another conviction for failure to obey a traffic sign.

Alfredo Reyes

    Mr. Reyes, 57, has had amblyopia in his left eye since childhood.
The best corrected visual acuity in his right eye is 20/20 and in his
left eye, 20/60. Following an examination in 2010, his optometrist
noted, ``I can see no reason why he can not perform the visual tasks
necessary to drive any type of vehicle including commerical vehicles.''
Mr. Reyes reported that he has driven straight trucks for 15 years,
accumulating 600,000 miles and tractor-trailer combinations for 20
years accumulating 2.1 million miles. He holds a Class A CDL from
Texas. His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

Ronald M. Robinson

    Mr. Robinson, 60, has monocular vision due to a traumatic injury to
his right eye that occurred 40 years ago. The visual acuity in his left
eye is 20/20. Following an examination in 2010, his optometrist noted,
``In my opinion, Mr. Robinson has full capability to operate a
commerical vehicle provided that it has the standard right and left
outsider rearview mirrors.'' Mr. Robinson reported that he has driven
straight trucks 20 years, accumulating 300,000 miles. He holds a Class
D operator's license from Kentucky. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

J. Bernando Rodriguez

    Mr. Rodriguez, 47, has had strabismic amblyopia in his left eye
since childhood. The best corrected visual acuity in his right eye is
20/20 and in his left eye, 20/400. Following an examination in 2010,
his optometrist noted, ``I. Dr. Edgardo Amaro, certify that in my
medical opinion, patient J. Bernardo Rodriguez, has sufficient vision
to perform the driving tasks required to operate a commerical vehicle
as he has been doing in the past 10 years.'' Mr. Rodriguez reported
that he has driven tractor-trailer combinations 8 years accumulating
800,000 miles. He holds a Class A CDL from Texas. His driving record
for the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Esequiel Rodriguez, Jr.

    Mr. Rodriguez, 38, has had a macular scar in his right eye since
birth. The visual acuity in his right eye is 20/200 and in his left
eye, 20/20. Following an examination in 2010, his optometrist noted,
``He is fully capable of operating a commerical vehicle.'' Mr.
Rodriguez reported that he has driven tractor-trailer combinations 7
years accumulating 805,000 miles. He holds a Class A CDL from Texas.
His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

David I. Sosby

    Mr. Sosby, 60, has had amblyopia in his left eye since childhood.
The best corrected visual acuity in his right eye is 20/20 and in his
left eye, 20/200. Following an examination in 2010, his optometrist
noted, ``I Renapate, OD, hereby certify David Sosby to be visually able
to safely operate a commerical motor vehicle.'' Mr. Sosby reported that
he has driven tractor-trailer combinations 30 years accumulating 2.4
million miles. He holds a Class A CDL from Kentucky. His driving record
for the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Donald E. Stone

    Mr. Stone, 54, has optic atrophy in his left eye due to a traumatic
injury. The best corrected visual acuity in his right eye is 20/15 and
in his left eye, hand motion vision. Following an examination in 2010,
his optometrist noted, ``It is my opinion that Mr. Stone has sufficient
vision to operate a commerical motor vehicle.'' Mr. Stone reported that
he has driven straight trucks 10 years, accumulating 900,000 miles and
tractor-trailer combinations for 17 years accumulating 1.8 million
miles. He holds a Class A CDL from Virginia. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. The Agency will consider all comments
received before the close of business April 28, 2011. Comments will be
available for examination in the docket at the location listed under
the ADDRESSES section of this notice. The Agency will file comments
received after the comment closing date in the public docket, and will
consider them to the extent practicable.
    In addition to late comments, FMCSA will also continue to file, in
the public docket, relevant information that becomes available after
the comment closing date. Interested persons should monitor the public
docket for new material.

    Issued on: March 16, 2011.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2011-7258 Filed 3-28-11; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 84, Number 101 (Friday, May 24, 2019)]
[Notices]
[Page 24135]
[FR Doc No: 2019-10954]

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ENVIRONMENTAL PROTECTION AGENCY

[CERCLA-04-2018-3763; FRL-9994-05-Region 4]

Ward Transformer Superfund Site; Raleigh, North Carolina; Notice
of Settlement

AGENCY: Environmental Protection Agency.

ACTION: Notice of settlement.

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

SUMMARY: Under 122(h) of the Comprehensive Environmental Response,
Compensation and Liability Act (CERCLA), the United States
Environmental Protection Agency has entered into a settlement agreement
with Pharmacia LLC, concerning the Ward Transformer Superfund Site
located in Raleigh, North Carolina. The settlement addresses recovery
of CERCLA costs for a cleanup action performed by the EPA at the Site.

DATES: The Agency will consider public comments on the settlement until
June 24, 2019. The Agency will consider all comments received and may
modify or withdraw its consent to the proposed settlement if comments
received disclose facts or considerations which indicate that the
proposed settlement is inappropriate, improper, or inadequate.

ADDRESSES: Copies of the settlement are available from the Agency by
contacting Ms. Paula V. Painter, Program Analyst, using the contact
information provided in this document. Comments may also be submitted
by referencing the site's name through one of the following methods:
Internet: https://www.epa.gov/aboutepa/about-epa-region-4-southeast#r4-public-notices.
     U.S. Mail: U.S. Environmental Protection Agency, Superfund
Division, Attn: Paula V. Painter, 61 Forsyth Street SW, Atlanta,
Georgia 30303
     Email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Paula V. Painter at<PHONE_NUMBER>.

    Dated: April 8, 2019.
Maurice L. Horsey, IV,
Chief, Enforcement and Community Engagement Branch, Superfund Division.
[FR Doc. 2019-10954 Filed 5-23-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: March 27, 2008 (Volume 73, Number 60)]
[Notices]
[Page 16394]
[DOCID:fr27mr08-86]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57545; File No. 4-429]

Joint Industry Plan; Notice of Filing and Immediate Effectiveness
of Amendment to the Plan for the Purpose of Creating and Operating an
Options Intermarket Linkage To Add the Nasdaq Stock Market LLC as a
Participant

March 21, 2008.
    Pursuant to Section 11A(a)(3) of the Securities Exchange Act of
1934 (``Act'') \1\ and Rule 608 thereunder,\2\ notice is hereby given
that on January 30, 2008, the Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') an amendment to the Plan for the Purpose of Creating
and Operating an Options Intermarket Linkage (``Linkage Plan'').\3\ The
amendment proposes to add Nasdaq as a Participant \4\ to the Linkage
Plan. The Commission is publishing this notice to solicit comments on
the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78k-1(a)(3).
    \2\ 17 CFR 242.608.
    \3\ On July 28, 2000, the Commission approved a national market
system plan for the purpose of creating and operating an intermarket
options market linkage (``Linkage'') proposed by American Stock
Exchange LLC (``Amex''), Chicago Board Options Exchange, Inc.
(``CBOE''), and International Securities Exchange LLC (``ISE''). See
Securities Exchange Act Release No. 43086 (July 28, 2000), 65 FR
48023 (August 4, 2000). Subsequently, Philadelphia Stock Exchange,
Inc. (``Phlx''), Pacific Exchange, Inc. (``PCX'') (n/k/a NYSE Arca),
and Boston Stock Exchange, Inc. (``BSE'') joined the Linkage Plan.
See Securities Exchange Act Release Nos. 43573 (November 16, 2000),
65 FR 70851 (November 28, 2000); 43574 (November 16, 2000), 65 FR
70850 (November 28, 2000); and 49198 (February 5, 2004), 69 FR 7029
(February 12, 2004).
    \4\ The term ``Participant'' is defined as an Eligible Exchange
whose participation has become effective pursuant to Section 4(c) of
the Linkage Plan.
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I. Description and Purpose of the Amendment

    The current Participants in the Linkage Plan are Amex, BSE, CBOE,
ISE, NYSE Arca, and Phlx. The proposed amendment to the Linkage Plan
would add Nasdaq as a Participant in the Linkage Plan. Nasdaq has
submitted a signed copy of the Linkage Plan to the Commission in
accordance with the procedures set forth in the Linkage Plan regarding
new Participants. Section 4(c) of the Linkage Plan provides for the
admission of new Participants. Specifically an Eligible Exchange \5\
may become a Participant in the Linkage Plan by: (i) Executing a copy
of the Linkage Plan, as then in effect; (ii) providing each current
Participant with a copy of such executed Linkage Plan; (iii) effecting
an amendment to the Linkage Plan, as specified in Section 5(c)(ii) of
the Linkage Plan; and (iv) paying the applicable new Participant fee.
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    \5\ The Linkage Plan defines an ``Eligible Exchange'' as a
national securities exchange registered with the Commission pursuant
to Section 6(a) of the Act, 15 U.S.C. 78f(a), that is (a) a
``Participant Exchange'' in the Options Clearing Corporation
(``OCC'') (as defined in OCC By-laws, Section VII) and (b) a party
to the Options Price Reporting Authority (``OPRA'') Plan (as defined
in the OPRA Plan, Section 1). Nasdaq has represented that it has met
both the requirements for being considered an Eligible Exchange. See
letter from Jeffrey S. Davis, Vice President and Deputy General
Counsel, Nasdaq, to Elizabeth King, Associate Director, Division of
Trading and Markets, Commission, dated March 20, 2008.
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    Section 5(c)(ii) of the Linkage Plan puts forth the process by
which an Eligible Exchange may effect an amendment to the Linkage Plan.
Specifically, an Eligible Exchange must: (a) Execute a copy of the
Linkage Plan with the only change being the addition of the new
participant's name in Section 4(a) of the Linkage Plan; (b) submit the
executed Linkage Plan to the Commission; and (c) pay the then current
new participant fee. The Linkage Plan then provides that such an
amendment will be effective at the later of either the amendment being
approved by the Commission or otherwise becoming effective pursuant to
Section 11A of the Act and the payment of the new Participant fee.

II. Effectiveness of the Proposed Linkage Plan Amendment

    The foregoing proposed Linkage Plan amendment has become effective
pursuant to Rule 608(c)(3)(iii) \6\ because it involves solely
technical or ministerial matters. At any time within sixty days of the
filing of this amendment, the Commission may summarily abrogate the
amendment and require that it be refiled pursuant to paragraphs (b)(1)
of Rule 608,\7\ if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors or the maintenance of fair and orderly markets, to remove
impediments to, and perfect the mechanisms of, a national market system
or otherwise in furtherance of the purposes of the Act.
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    \6\ 17 CFR 242.608(b)(3)(iii).
    \7\ 17 CFR 242.608(b)(1).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number 4-429 on the subject line.

Paper Comments

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

All submissions should refer to File Number 4-429. This file number
should be included on the subject line if e-mail is used. To help the
Commission process and review your comments more efficiently, please
use only one method. The Commission will post all comments on the
Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for inspection and copying in the
Commission's Public Reference Room, 100 F Street, NE., Washington, DC
20549, on official business days between the hours of 10 a.m. and 3
p.m. Copies of such filing also will be available for inspection and
copying at the principal office of Nasdaq. 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 4-429 and should be submitted on or before
April 17, 2008.
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    \8\ 17 CFR 200.30-3(a)(29).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E8-6254 Filed 3-26-08; 8:45 am]

BILLING CODE 8011-01-P