[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Notices]
[Pages 51989-51993]
[FR Doc No: 2022-18275]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1048]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Labeling Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 medical device labeling regulations.

DATES: Either electronic or written comments on the collection of
information must be submitted by October 24, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 24, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-N-1048 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device Labeling
Regulations.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 Device Labeling Regulations

OMB Control Number 0910-0485--Revision

    This information collection supports implementation of medical
device labeling requirements governed by section 502 of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352), codified in
Agency regulations, and discussed in associated Agency guidance. In
accordance with the Unique Device Identification (UDI) system (see part
801, subpart B (21 CFR part 801, subpart B)), medical device labelers,
unless excepted, are required to design and use medical device labels
and device packages to bear a UDI, present dates on labels in a
particular format, and submit data concerning each version or model of
a device to the Global Unique Device Identification Database (GUDID) no
later than the date the label of the device must bear a UDI. Once a
device becomes subject to UDI requirements, respondents will be
required to update the information reported whenever the information
changes.
    FDA has identified the following requirements as having burdens
that must be accounted for under the PRA; the burdens associated with
these requirements are summarized in the table that follows.
    21 CFR 801.18 requires that whenever a labeler of a medical device
includes an expiration date, a date of manufacture, or any other date
intended to be brought to the attention of the user of the device, the
labeler must present the date on the label in a format that meets the
requirements of this section.
    Section 801.20 requires every medical device label and package to
bear a UDI.
    Under Sec.  801.35, any labeler of a device that is not required to
bear a UDI on its label may include a UDI on the label of that device
and utilize the GUDID.
    Under Sec.  801.45, any device that has to be labeled with a UDI
also has to bear a permanent marking providing the UDI on the device
itself if the device is intended for more than one use and intended to
be reprocessed before each use.
    Section 801.50 requires stand-alone software to comply with
specific labeling requirements that identify the software.
    Section 801.55 authorizes additional, case-by-case, labeling
exceptions and alternatives to standard UDI labeling requirements.
    If a labeler relabels or modifies a label of a device that is
required to bear a UDI, under 21 CFR 830.60 it has to keep a record
showing the relationship of the original device identifier to the new
device identifier.
    21 CFR 830.110 requires an applicant seeking initial FDA
accreditation as a UDI-issuing agency to furnish FDA an application
containing certain information, materials, and supporting
documentation.
    Under 21 CFR 830.120, an FDA-accredited issuing agency is required
to disclose information concerning its system for the assignment of
UDIs; maintain a list of labelers that use its system for the
assignment of UDIs and provide FDA a copy of such list; and upon
request, provide FDA with information concerning a labeler that is
employing the issuing agency's system for assignment of UDIs.
    21 CFR 830.310 and 830.320 require the labeler to provide certain
information to the GUDID concerning the labeler and each version or
model of a device required to be labeled with a UDI, unless the labeler
obtains a waive.
    21 CFR 830.360 requires each labeler to retain records showing all
UDIs used to identify devices that must be labeled with a UDI and the
particular version or model associated with each device identifier,
until 3 years after it ceases to market a version or model of a device.
    Respondents who are required to submit data to the Agency under
certain other approved information collections are required to include
UDI data elements for the device that is the subject of such
information collection. Addition of the UDI data elements is included
in this burden estimate for the conforming amendments in the following
21 CFR parts: part 803--Medical Device Reporting (OMB control number
0910-0437), part 806--Medical Devices; Reports of Corrections and
Removals (OMB control number 0910-0359), part 814--Premarket Approval
of Medical Devices (OMB control number 0910-0231), part 820--Quality
System Regulation (OMB control number 0910-0073), part 821--Medical
Device Tracking Requirements (OMB control number 0910-0442), and part
822--Postmarket Surveillance (OMB control number 0910-0449).
    Medical device labeling requirements, among other things, provide
for the label or labeling content of a medical device so that it is not
misbranded and subject to regulatory action. Certain provisions under
section 502 of the FD&C Act require that manufacturers, importers, and
distributors of medical devices disclose information about themselves
or the devices on the labels or labeling for the devices. Section 502
of the FD&C Act provides, in part, that a device shall be misbranded
if, among other things, its label or labeling fails to bear certain
required information concerning the device, is false or misleading in
any particular way, or fails to contain adequate directions for use.
Medical device labeling regulations in parts 800, 801, 809, and
associated regulations in parts 660 and 1040 (21 CFR parts 660, 800,
801, 809, and 1040), prescribe the disclosure of specific information
by manufacturers, importers, and distributors of medical devices about
themselves and/or the devices, on the label or labeling for the
devices, to health professionals and consumers.
    In conjunction with provisions in part 800, part 801, subpart A
sets forth general labeling provisions applicable to all medical
devices, including content and format requirements pertaining to
intended uses, adequate directions for use, misleading statements, and
the prominence of required labeling. Information collection associated
with labeling requirements for Over-the-Counter (OTC) Devices are found
in part 801, subpart C, and cover principal display panel; statement of
identity; declaration of net quantity of contents; and certain warning
statement elements. Information collection associated with exemptions
from adequate directions for use and other exemptions are found in part
801, subparts D and E, respectively. Information collection associated
with special labeling requirements applicable to specific devices are
found in part 801, subpart H. We also include information collection
associated with labeling for in vitro diagnostic products for human
use, as set forth in part 809, subpart B. In addition to the labeling
requirements in part 801 and the certification and identification
requirements of 21 CFR 1010.2 and 1010.3, sunlamp products and
ultraviolet lamps are subject to specific labeling requirements as set
forth in part 1040.
    The information collection also includes provisions associated with
stand-alone symbols (not accompanied by explanatory text adjacent to
the symbol), when accompanied by a symbols glossary, as set forth in
part 660, additional standards for diagnostic substances for laboratory
standards for biological products, subparts A, C, D, E, and F. The
requirements are also found in the general medical device labeling
regulations part 801, subpart A, and part 809, subpart B.
    The information collection also helps to implement section 502(b)
of the FD&C Act which requires that, for packaged devices, labeling
must bear the name and place of business of the manufacturer, packer,
or distributor;

and an accurate statement of the quantity of the contents. Section
502(f) of the FD&C Act requires also that the labeling for a device
must contain adequate directions for use unless FDA grants an
exemption. Section 502(u) of the FD&C Act requires reprocessed single-
use devices (SUDs) to bear prominently and conspicuously the name of
the manufacturer, a generally recognized abbreviation of such name, or
a unique and generally recognized symbol identifying the manufacturer.
Under this provision, if the original SUD or an attachment to it
prominently and conspicuously bears the name of the manufacturer, then
the reprocessor of the SUD is required to identify itself by name,
abbreviation, or symbol in a prominent and conspicuous manner on the
device or attachment to the device. If the original SUD does not
prominently and conspicuously bear the name of the manufacturer, the
manufacturer who reprocesses the SUD for reuse may identify itself
using a detachable label that is intended to be affixed to the patient
record. As required by the Medical Device User Fee Stabilization Act of
2005, FDA issued the guidance document, ``Compliance with Section 301
of the Medical Device User Fee and Modernization Act of 2002, as
amended--Prominent and Conspicuous Mark of Manufacturers on Single-Use
Devices'' (May 2006), to assist respondents with these requirements.
The guidance document was issued consistent with our Good Guidance
Practice regulations in 21 CFR 10.115, which provide for public comment
at any time. We maintain a searchable guidance database on our website,
and this guidance is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
    The guidance document is intended to identify circumstances in
which the name or symbol of the original SUD manufacturer is not
prominent and conspicuous, as used in section 502(u) of the FD&C Act.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
               21 CFR citation                   Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
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   Part 660, subparts A, C, D, E, and F: Antibody to Hepatitis B Surface Antigen; Blood Grouping Reagent; Reagent Red Blood Cells; Hepatitis B Surface
                            Antigen; Anti-Human Globulin; Part 801 subpart A: General Labeling; Part 809, subpart B: Labeling
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Symbols glossary--660.2; antibody to                   3,000               1           3,000  1.........................................           3,000
 Hepatitis B surface antigen requirements,
 660.28; blood grouping labeling, 660.35;
 reagent red blood cell labeling, 660.45,
 hepatitis B surface antigen labeling,
 660.55; anti-human globulin labeling,
 801.15; medical devices labeling and use of
 symbols; 809.10, labeling for in vitro
 diagnostic products.
UDI; part 801, subpart B....................       \2\ 6,199              51     \3\ 316,149  0.0167 (1 minute).........................           5,280
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    Total...................................  ..............  ..............  ..............  ..........................................           8,280
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Maximum No. of Respondents for any regulatory requirement within each category. Individual regulatory requirements within the category may involve
  fewer respondents.
\3\ Maximum Total Annual Responses for any regulatory requirement within each category. Individual regulatory requirements within the category may
  involve fewer total annual responses.

    Our figures are based on data from the FDA Unified Registration and
Listing System and the Operational and Administration System for Import
Support shipment information. FDA regulations allow for the use of
stand-alone graphical representations of information, or symbols, in
the labeling for the medical devices and diagnostic substances for
laboratory standards, if the symbol has been established in a Standards
Development Organization developed standard, provided that such symbol
is explained in a symbols glossary that is included in the labeling for
the medical device and otherwise complies with section 502
(misbranding) of the FD&C Act. These labeling requirements are set
forth in part 660, subparts A, C, D, E, and F, in the additional
standards for diagnostic substances for laboratory standards for
biological products, including: general requirements (Sec.  660.2),
using antibody to Hepatitis B surface antigen (Sec.  660.28), blood
grouping reagent (Sec.  660.35), reagent red blood cells (Sec.
660.45), Hepatitis B surface antigen (Sec.  660.45); and anti-human
globulin (Sec.  660.55). The requirements are also found in the general
medical device labeling regulations (part 801, subpart A) and in the in
vitro diagnostic product labeling regulations (part 809, subpart B).

                                                 Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
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                                                                 Number of
               21 CFR citation                   Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
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           Part 801 subpart A: General Labeling Provisions; subpart E: Other Exemptions; subpart H: Special Requirements for Specific Devices
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Processing, labeling, or repacking                     7,500             887       6,652,500  0.5 (30 minutes)..........................       3,326,250
 agreement; 801.150.

Impact resistant lenses; invoices, shipping            1,591          47,050      74,856,550  0.0008 (0.048 minutes)....................          59,885
 documents, and records of sale or
 distribution; 801.410(e) and (f).
Hearing aid records; 801.421................          10,000             160       1,600,000  0.25 (15 minutes).........................         400,000
Menstrual tampons, sampling plan for                      33              11             363  80........................................          29,040
 measuring absorbency; 801.430(f).
Latex condoms; justification for the                      51            3.65             186  1.........................................             186
 application of testing data to the
 variation of the tested product; 801.435(g).
UDI; part 801, subpart B....................       \3\ 5,987              51     \4\ 305,337  0.9833 (59 minutes).......................         300,238
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    Total...................................  ..............  ..............      83,414,936  ..........................................       4,115,599
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.
\3\ Maximum No. of Respondents for any regulatory requirement within each category. Individual regulatory requirements within the category may involve
  fewer respondents.
\4\ Maximum Total Annual Responses for any regulatory requirement within each category. Individual regulatory requirements within the category may
  involve fewer total annual responses.

    As set forth in Sec.  801.150(a)(2), device manufacturers are
required to retain a copy of the agreement containing the
specifications for the processing, labeling, or repacking of the device
for 2 years after the final shipment or delivery of the device. Section
801.150(a)(2) requires that copies of this agreement be made available
for inspection at any reasonable hour upon request by any officer or
employee of the Department of Health and Human Services (HHS). In Sec.
801.410(e) copies of invoices, shipping documents, and records of sale
or distribution of all impact resistant lenses, including finished
eyeglasses and sunglasses, are required to be maintained for 3 years by
the retailer and made available upon request by any officer or employee
of FDA or by any other officer or employee acting on behalf of the
Secretary of HHS. Section 801.410(f) requires that the results of
impact tests and description of the test method and apparatus be
retained for a period of 3 years.
    Specific recordkeeping requirements applicable to hearing aid
dispensers, manufacturers of menstrual tampons, and manufacturers of
latex condoms are set forth in Sec. Sec.  801.421(d), 801.430(f), and
801.435(g), respectively.

                                             Table 3--Estimated Annual Third-Party Disclosure Burden \1\ \2\
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                                                                 Number of
               21 CFR citation                   Number of      disclosures    Total annual          Average burden per disclosure          Total hours
                                                respondents   per respondent    disclosures
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                                Part 800 and Part 801, subparts A, C, D, and E: General Labeling; OTC Devices; Exemptions
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Contact lens cleaning solution labeling;                  47               8             376  1.........................................             376
 800.10(a)(3) and 800.12(c).
Liquid ophthalmic preparation labeling;                   25               8             200  1.........................................             200
 800.10(b)(2).
Manufacturer, packer, or distributor                  19,407               7         135,849  1.........................................         135,849
 information; 801.1.
Adequate directions for use; 801.5..........           8,526               6          51,156  22.35.....................................       1,143,337
Statement of identity; 801.61...............           8,526               6          51,156  1.........................................          51,156
Declaration of net quantity of contents;               8,526               6          51,156  1.........................................          51,156
 801.62.
Prescription device labeling; 801.109.......           9,681               6          58,086  17.77.....................................       1,032,188
Retail exemption for prescription devices;            30,000             667      20,010,000  0.25......................................       5,002,500
 801.110.
Processing, labeling, or repacking; non-                 453              34          15,402  4.........................................          61,608
 sterile devices; 801.150(e).
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                                             Part 801, subpart H: Special Requirements for Specific Devices
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Labeling of articles intended for lay use in              35               1              35  4.........................................             140
 the repairing and/or refitting of dentures;
 801.405(b)(1).
Dentures; information regarding temporary                 35               1              35  4.........................................             140
 and emergency use; 801.405(c).
Hearing aids professional and patient                    136              12           1,632  80........................................         130,560
 labeling; 801.420.
Hearing aids, availability of User                    10,000               5          50,000  0.17......................................           8,500
 Instructional Brochure; 801.421.
User labeling for menstrual tampons; 801.430              16               8             128  2.........................................             256
User labeling for latex condoms; 801.437....              52               6             312  100.......................................          31,200
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                              Part 809 (in vitro diagnostic products for human use) and part 1040 (light-emitting products)
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Format and content of labeling for IVDs;               1,700               6          10,200  80........................................         816,000
 809.10.
Advertising and promotional materials for                300              25           7,500  1.........................................           7,500
 ASRs; 809.30(d).
Labeling of sunlamp products--1040.20(d)....              30               1              30  10........................................             300
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                                                               FD&C Action Section 502(u)
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Establishments listing <10 SUDs.............             161               2             322  0.1 (6 minutes)...........................              32
Establishments listing >10 SUDs.............              14              45             630  0.1 (6 minutes)...........................              63
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   Part 660, subparts A, C, D, E, and F: Antibody to Hepatitis B Surface Antigen; Blood Grouping Reagent; Reagent Red Blood Cells; Hepatitis B Surface
                      Antigen; Anti-Human Globulin; Part 801 subpart A: General Labeling Provisions; Part 809, subpart B: Labeling
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Symbols glossary--660.2; antibody to                   3,000               1           3,000  4.........................................          12,000
 Hepatitis B surface antigen requirements,
 660.28; blood grouping labeling, 660.35;
 reagent red blood cell labeling, 660.45,
 hepatitis B surface antigen labeling,
 660.55; anti-human globulin labeling,
 801.15; medical devices labeling and use of
 symbols; 809.10, labeling for in vitro
 diagnostic products.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Part 801, subpart B
--------------------------------------------------------------------------------------------------------------------------------------------------------
UDI.........................................       \3\ 5,987              51     \4\ 305,337  0.8833 (53 minutes).......................         269,704
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............      20,752,542  ..........................................       8,754,765
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.
\3\ Maximum No. of Respondents for any regulatory requirement within each category. Individual regulatory requirements within the category may involve
  fewer respondents.
\4\ Maximum Total Annual Responses for any regulatory requirement within each category. Individual regulatory requirements within the category may
  involve fewer total annual responses.

    Because many labeling provisions correspond to specific
recordkeeping requirements, we have accounted for burden attendant to
the provisions enumerated in table 3 as third-party disclosures. These
figures reflect what we believe to be the average burden incurred by
respondents to applicable information collection activities.
    We are revising this information collection to include OMB control
number 0910-0720. Our estimated burden for the information collection
reflects an overall increase of 579,633 hours and a corresponding
increase of 926,823 responses/records. We attribute this adjustment to
the revision of this information collection to include OMB control
number 0910-0720.

    Dated: August 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18275 Filed 8-23-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 90 (Tuesday, May 10, 2011)]
[Notices]
[Pages 27040-27041]
[FR Doc No: 2011-11372]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER11-2054-001
    Applicants: Ameren Illinois Company
    Descrption: Ameren Illinois Company submits tariff filing per 35:
Compliance Filing of Ameren Illinois Company for Rate Schedules 114,
115, 130 to be effective 5/3/2011.
    Filed Date: 05/03/2011
    Accession Number: 20110503-5000
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 24, 2011

    Docket Numbers: ER11-2093-001
    Applicants: Ameren Illinois Company
    Descrption: Ameren Illinois Company submits tariff filing per 35:
Compliance Filing for Ameren Illinois for Rate Schedules 101, 108, 137,
138 to be effective 5/4/2011.
    Filed Date: 05/03/2011
    Accession Number: 20110503-5123
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 24, 2011

    Docket Numbers: ER11-2181-001
    Applicants: Ameren Illinois Company
    Descrption: Ameren Illinois Company submits tariff filing per 35:
Compliance Filing for Ameren Illinois for Rate Schedules 134, 135, 136
to be effective 5/4/2011.
    Filed Date: 05/03/2011
    Accession Number: 20110503-5137
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 24, 2011

    Docket Numbers: ER11-3504-000
    Applicants: Southwest Power Pool, Inc.
    Descrption: Southwest Power Pool, Inc. submits tariff filing per
35.13(a)(2)(iii) Revision to Attachment AD Amended 2011 SWPA Agreement
to be effective 4/1/2011.
    Filed Date: 05/03/2011
    Accession Number: 20110503-5074
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 24, 2011

    Docket Numbers: ER11-3505-000
    Applicants: Public Service Company of Colorado
    Description: Public Service Company of Colorado submits tariff
filing per 35.13(a)(2)(iii) 2011-5-3--Att-O--SPS--BPU--Filing to be
effective 5/15/2011.
    Filed Date: 05/03/2011
    Accession Number: 20110503-5076
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 24, 2011

    Docket Numbers: ER11-3506-000
    Applicants: PJM Interconnection, L.L.C.
    Descrption: PJM Interconnection, L.L.C. submits tariff filing per
35.13(a)(2)(iii) Queue No. W1-120; Original Service Agreement No. 2857
to be effective 4/7/2011.
    Filed Date: 05/03/2011
    Accession Number: 20110503-5082
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 24, 2011

    Docket Numbers: ER11-3507-000
    Applicants: Western Electricity Coordinating Council
    Description: Notice to FERC of RMS Termination. Report/Form of
Western Electricity Coordinating Council.
    Filed Date: 05/03/2011
    Accession Number: 20110503-5124
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 24, 2011

    Docket Numbers: ER11-3508-000
    Applicants: American Transmission Systems, Incorporated
    Descrption: American Transmission Systems, Incorporated's 2011
Transmission Formula Rate Annual Update.
    Filed Date: 05/02/2011
    Accession Number: 20110502-5554
    Comment Date: 5 p.m. Eastern Time on Monday, May 23, 2011

    Docket Numbers: ER11-3509-000
    Applicants: Southwest Power Pool, Inc.
    Descrption: Southwest Power Pool, Inc. submits tariff filing per
35.13(a)(2)(iii) Ministerial Filing to Reflect Language Accepted in
Docket No. OA08-61-002, -003 to be effective 7/26/2010.

    Filed Date: 05/03/2011
    Accession Number: 20110503-5168
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 24, 2011

    Docket Numbers: ER11-3510-000
    Applicants: California Independent System Operator Corporation
    Descrption: California Independent System Operator Corporation
submits tariff filing per 35.13(a)(2)(iii) 2011-05-03 CAISO Filing
Clarify Provisions Relating to Self-Provisions Regulalated to be
effective 5/24/2011
    Filed Date: 05/03/2011
    Accession Number: 20110503-5198
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 24, 2011

    Docket Numbers: ER11-3511-000
    Applicants: Southwest Power Pool, Inc.
    Descrption: Southwest Power Pool, Inc. submits tariff filing per
35.13(a)(2)(iii) 549R6 Board of Public Utilities, Springfield, Missouri
NITSA NOA to be effective 4/4/2011.
    Filed Date: 05/03/2011
    Accession Number: 20110503-5202
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 24, 2011
    Docket Numbers: ER11-3512-000
    Applicants: Pacific Gas and Electric Company
    Descrption: Pacific Gas and Electric Company submits tariff filing
per 35.13(a)(2)(iii) CCSF Crystal Springs Removal Agreement to be
effective 7/5/2011.
    Filed Date: 05/03/2011
    Accession Number: 20110503-5247
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 24, 2011

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above, do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets the applicable criteria to be a
qualifying facility. Intervention and/or protest do not lie in dockets
that are qualifying facility self-certifications or self-
recertifications. Any person seeking to challenge such qualifying
facility status may do so by filing a motion pursuant to 18 CFR
292.207(d)(iii). Intervention and protests may be filed in response to
notices of qualifying facility dockets other than self-certifications
and self-recertifications.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: May 4, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-11372 Filed 5-9-11; 8:45 am]
BILLING CODE 6717-01-P


From: Klara Zimmerman<EMAIL_ADDRESS>Sent: Thursday, October 29, 2015 9:11 AM
To: [Addressees]
Cc: Wen, Chen<EMAIL_ADDRESS>Williams, Bridget<EMAIL_ADDRESS>Subject: Request for feedback on Safer Choice Partner of the Year Awards

I'm writing from Abt Associates on behalf of the U.S. Environmental Protection Agency's Safer Choice Program.  We're currently supporting Safer Choice in conducting research on the burden associated with its Partner of the Year Awards.  The Paperwork Reduction Act requires that federal agencies re-evaluate every three years the recordkeeping and reporting burden associated with information collection requests of this nature.

As a potential respondent, we would value your feedback about the burden associated with the Partner of the Year Awards to ensure that our estimates are reasonable.  In this ICR renewal, there is no change in the number of hours in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB.

Attached is a copy of the Information Collection Request (ICR) for the Safer Choice 2016 Partner of the Year Awards.  For your reference, here is a link to the federal register notice:  https://federalregister.gov/a/2015-25172.

Please give particular attention to Section 6 of the ICR, which includes burden estimates associated with the Partner of the Year Awards application.  When reviewing, please consider the following questions:

      (i) is the proposed collection of information necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility?;

      (ii) are the Agency's estimates of the burden of the proposed collection of information, including the validity of the methodology and assumptions used, reasonable and accurate?;

      (iii) could the quality, utility, and clarity of the information to be collected be improved?

We would greatly appreciate your feedback on the above items and also value your suggestions for future improvements to the Partner of the Year awards.  Please send me any comments or feedback by Tuesday, December 1st.

Thanks in advance for your time and assistance.

Sincerely,
Klara Zimmerman

Klara Zimmerman
Environment & Natural Resources Division | Abt Associates
4550 Montgomery Avenue Suite 800 North | Bethesda, MD 20814
301·634·1722 | www.abtassociates.com


[Federal Register Volume 83, Number 14 (Monday, January 22, 2018)]
[Notices]
[Pages 3048-3049]
[FR Doc No: 2018-01055]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2017-0132]

Notice of Application for Approval To Discontinue or Modify a
Railroad Signal System

    In accordance with Part 235 of Title 49 of the Code of Federal
Regulations (CFR) and 49 U.S.C. 20502(a), this

provides the public notice that on December 11, 2017, the Union Pacific
Railroad (UP) petitioned the Federal Railroad Administration (FRA)
seeking approval to discontinue or modify a signal system. FRA assigned
the petition Docket Number FRA-2017-0132.
    Applicant: Union Pacific Railroad, Mr. Kevin D. Hicks, AVP
Engineering--Design, 1400 Douglas Street, MS 0910, Omaha, NE 68179.
    Union Pacific seeks to retire the control point (CP) NA Jct.
(Nepesta) on the Tennessee Pass Subdivision in the state of Colorado.
The CP is no longer used. It will be replaced with an intermediate
signal on the main track and a leaving signal in the siding. The
existing #20 power-operated switch will be replaced with a #11 hand-
operated switch. The purpose of this replacement is to remove unused
equipment and to expedite train movements in the area.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's Docket Operations Facility, 1200 New Jersey Avenue SE,
W12-140, Washington, DC 20590. The Docket Operations Facility is open
from 9 a.m. to 5 p.m., Monday through Friday, except Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by March 8, 2018 will be considered by FRA
before final action is taken. Comments received after that date will be
considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. DOT posts these comments, without edit, including
any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the
privacy notice of regulations.gov.

Robert C. Lauby,
Associate Administrator for Safety, Chief Safety Officer.
[FR Doc. 2018-01055 Filed 1-19-18; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register Volume 76, Number 68 (Friday, April 8, 2011)]
[Rules and Regulations]
[Pages 19707-19708]
[FR Doc No: 2011-8292]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Office of the Secretary of Transportation

49 CFR Part 8

[Docket No. DOT-OST-1999-6189]
RIN 9991-AA58

Classified Information: Classification/Declassification/Access;
Authority To Classify Information

AGENCY: Office of the Secretary of Transportation (OST), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: This final rule delegates various authorities vested in the
Secretary of Transportation (Secretary) by Executive Order 13526 to
originally classify information as SECRET or CONFIDENTIAL to the
Administrator of the Federal Aviation Administration, and to the
Assistant Administrator for Security and Hazardous Materials.

DATES: This final rule is effective April 8, 2011.

FOR FURTHER INFORMATION CONTACT: Brett Jortland, Attorney, Office of
the General Counsel, U.S. Department of Transportation, 1200 New Jersey
Avenue, SE., Washington, DC 20590, E-mail<EMAIL_ADDRESS>
Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Executive Order 13526 confers upon the
Secretary the authority to originally classify information as SECRET or
CONFIDENTIAL, with further authorization to designate this authority.
Title 49 of the Code of Federal Regulations (CFR), Section 8.11(b)(3)
delegates this authority to the Administrator of the Federal Aviation
Administration (FAA), and the Assistant Administrator for Civil
Aviation Security. As a result of administrative changes within the
FAA, the position of the Assistant Administrator for Civil Aviation
Security no longer exists. The authority exercised by that position has
been transferred to the Assistant Administrator for Security and
Hazardous Materials, thus necessitating a change in the language of
Sec.  8.11(b)(3) to reflect the proper office for designation of this
authority.
    In addition, following the creation of the Department of Homeland
Security, and the transfer of the United States Coast Guard from DOT to
the Department of Homeland Security, the delegation of authority from
the Secretary to the United States Coast Guard is hereby removed and
the section is renumbered accordingly.
    Since these amendments relate to departmental management,
organization, procedure, and practice, notice and comment are
unnecessary under 5 U.S.C. 553(b). Further, since these amendments
expedite DOT's ability to meet the statutory intent of the applicable
laws and regulations covered by this delegation, the Secretary finds
good cause under 5 U.S.C. 553(d)(3) for the final rule to be effective
on the date of publication in the Federal Register.

Regulatory Impact and Notices

A. Executive Order 12866 and DOT Regulatory Policies and Procedures

    The final rule is not considered a significant regulatory action
under Executive Order 12866 and DOT Regulatory Policies and Procedures.
See 44 FR 11034, Feb. 26, 1979. There are no costs associated with this
rule.

B. Regulatory Flexibility Act and Executive Order 13272

    Because no notice of proposed rulemaking is required for this rule
under the Administrative Procedure Act, 5 U.S.C. 553, the provisions of
the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) do not apply. We
also do not believe that this rule would impose any costs on small
entities because it simply delegates authority from one official to
another. Therefore, I certify that this final rule will not have a
significant economic impact on a substantial number of small
businesses.

C. Paperwork Reduction Act

    This rule contains no information collection requirements under the
Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

D. Federalism Implications

    This final rule has been analyzed in accordance with the principles
and criteria contained in Executive Order 13132 (``Federalism''). This
final rule does not have a substantial direct effect on, or sufficient
federalism implications for, the States, nor would it limit the
policymaking discretion of the States. Therefore, the consultation
requirements of Executive Order 13132 do not apply.

E. Executive Order 13175

    This final rule has been analyzed in accordance with the principles
and criteria contained in Executive Order 13175 (``Consultation and
Coordination with Indian Tribal Governments''). Because this final rule
does not significantly or uniquely affect the communities of the Indian
Tribal governments and does not impose substantial direct compliance
costs, the funding and consultation requirements of Executive Order
13175 do not apply.

F. Unfunded Mandates Reform Act of 1995

    DOT has determined that the requirements of title II of the
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 2 U.S.C. 1531) do
not apply to this rulemaking.

List of Subjects in 49 CFR Part 8

    Classified Information (Government agencies), Classification/
Declassification/Access (Government agencies).

The Final Rule

    For the reasons set forth in the preamble, OST amends 49 CFR part 8
as follows:

PART 8--[AMENDED]

0
1. The authority citation for part 8 continues to read as follows:

    Authority:  E. O. 10450, 3 CFR, 1949-1953 Comp., p. 936; E.O.
12829, 3 CFR, 1993 Comp., p. 570; E.O. 12958, 3 CFR, 1995 Comp., p.
333; E. O. 12968, 3 CFR, 1995 Comp., p. 391.

Subpart B--Classification/Declassification of Information

Sec.  8.11  [Amended]

0
2. Section 8.11 is amended as follows:
0
a. By removing paragraph (b)(2),
0
b. By redesignating paragraphs (b)(3) and (b)(4) as (b)(2) and (b)(3)
0
c. By amending newly designated paragraph (b)(2) by removing the
reference ``Assistant Administrator for Civil Aviation Security'', and
by adding in its place, the reference ``Assistant Administrator for
Security and Hazardous Materials.''

    Issued in Washington, DC, on March 30, 2011.
Ray LaHood,
Secretary of Transportation.
[FR Doc. 2011-8292 Filed 4-7-11; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register: May 1, 2007 (Volume 72, Number 83)]
[Notices]
[Page 23808-23809]
[DOCID:fr01my07-47]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER03-509-000]

Centennial Power, Inc.; Notice of Issuance of Order

April 24, 2007.
    Centennial Power, Inc. (Centennial Power) filed an application for
market-based rate authority, with an accompanying tariff. The proposed
market-based rate tariff provides for the sale of energy, capacity and
ancillary services at market-based rates. Centennial Power also
requested waivers of various Commission regulations. In particular,
Centennial

Power requested that the Commission grant blanket approval under 18 CFR
part 34 of all future issuances of securities and assumptions of
liability by Centennial.
    On March 7, 2003, pursuant to delegated authority, the Director,
Division of Tariffs and Market Development--West, granted the requests
for blanket approval under part 34 (Director's Order). The Director's
Order also stated that the Commission would publish a separate notice
in the Federal Register establishing a period of time for the filing of
protests. Accordingly, any person desiring to be heard concerning the
blanket approvals of issuances of securities or assumptions of
liability by Centennial Power should file a protest with the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426, in accordance with Rules 211 and 214 of the Commission's Rules
of Practice and Procedure. 18 CFR 385.211, 385.214 (2004).
    Notice is hereby given that the deadline for filing protests is May
23, 2007.
    Absent a request to be heard in opposition to such blanket
approvals by the deadline above, Centennial Power is authorized to
issue securities and assume obligations or liabilities as a guarantor,
indorser, surety, or otherwise in respect of any security of another
person; provided that such issuance or assumption is for some lawful
object within the corporate purposes of Centennial Power, compatible
with the public interest, and is reasonably necessary or appropriate
for such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of Centennial Power's issuance of securities or
assumptions of liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the Internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-8211 Filed 4-30-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 75, Number 227 (Friday, November 26, 2010)]
[Notices]
[Pages 72850-72855]
[FR Doc No: 2010-29727]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63331; File No. SR-FINRA-2010-059]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of Proposed Rule Change To Adopt
FINRA Rule 4360 (Fidelity Bonds) in the Consolidated FINRA Rulebook

November 17, 2010.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'' or ``Exchange Act'') \2\ and Rule 19b-4 thereunder,\3\
notice is hereby given that on November 10, 2010, Financial Industry
Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of
Securities Dealers, Inc. (``NASD'')) filed with the Securities and
Exchange Commission (``SEC'' or ``Commission'') the proposed rule
change as described in Items I, II, and III below, which Items have
been prepared by FINRA. 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\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    FINRA is proposing to adopt NASD Rule 3020 (Fidelity Bonds) with
certain changes into the consolidated FINRA rulebook as FINRA Rule 4360
(Fidelity Bonds), taking into account Incorporated NYSE Rule 319
(Fidelity Bonds) and its Interpretation.
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal

office of FINRA 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, FINRA 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. FINRA 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
    As part of the process of developing a new consolidated rulebook
(``Consolidated FINRA Rulebook''),\4\ FINRA is proposing to adopt NASD
Rule 3020 as FINRA Rule 4360 (Fidelity Bonds), taking into account NYSE
Rule 319 (and its Interpretation).\5\ Proposed FINRA Rule 4360 would
update and clarify the fidelity bond requirements and better reflect
current industry practices. Unless otherwise noted below, the
provisions in NASD Rule 3020 would transfer, subject only to non-
substantive changes, as part of proposed FINRA Rule 4360.
---------------------------------------------------------------------------

    \4\ The current FINRA rulebook consists of: (1) FINRA Rules; (2)
NASD Rules; and (3) rules incorporated from NYSE (``Incorporated
NYSE Rules'') (together, the NASD Rules and Incorporated NYSE Rules
are referred to as the ``Transitional Rulebook''). While the NASD
Rules generally apply to all FINRA members, the Incorporated NYSE
Rules apply only to those members of FINRA that are also members of
the NYSE (``Dual Members''). The FINRA Rules apply to all FINRA
members, unless such rules have a more limited application by their
terms. For more information about the rulebook consolidation
process, see Information Notice, March 12, 2008 (Rulebook
Consolidation Process).
    \5\ For convenience, the Incorporated NYSE Rules are referred to
as the NYSE Rules.
---------------------------------------------------------------------------

    NASD Rule 3020 and NYSE Rule 319 (and its Interpretation) generally
require members to maintain minimum amounts of fidelity bond coverage
for officers and employees, and that such coverage address losses
incurred due to certain specified events. The purpose of a fidelity
bond is to protect a member against certain types of losses, including,
but not limited to, those caused by the malfeasance of its officers and
employees, and the effect of such losses on the member's capital.
General Provision
    NASD Rule 3020(a) generally provides that each member required to
join the Securities Investor Protection Corporation (``SIPC'') that has
employees and that is not a member in good standing of one of the
enumerated national securities exchanges must maintain fidelity bond
coverage; NYSE Rule 319(a) generally requires member organizations
doing business with the public to carry fidelity bonds. Like NASD Rule
3020, proposed FINRA Rule 4360 would require each member that is
required to join SIPC to maintain blanket fidelity bond coverage with
specified amounts of coverage based on the member's net capital
requirement, with certain exceptions.
    NASD Rule 3020(a)(1) requires members to maintain a blanket
fidelity bond in a form substantially similar to the standard form of
Brokers Blanket Bond promulgated by the Surety Association of America.
Under NYSE Rule 319(a), the Stockbrokers Partnership Bond and the
Brokers Blanket Bond approved by the NYSE are the only bond forms that
may be used by a member organization; NYSE approval is required for any
variation from such forms. Proposed FINRA Rule 4360 would require
members to maintain fidelity bond coverage that provides for per loss
coverage without an aggregate limit of liability. Members may apply for
this level of coverage with any product that meets these requirements,
including the Securities Dealer Blanket Bond (``SDBB'') or a properly
endorsed Financial Institution Form 14 Bond (``Form 14'').\6\
---------------------------------------------------------------------------

    \6\ Since 1982, firms electing to acquire coverage through the
FINRA-sponsored Insurance Program (``Sponsored Program'') have been
provided with the SDBB. It is the ``default'' insurance for FINRA
members in that when a firm completes the application for the
Sponsored Program, they are applying for the SDBB.
---------------------------------------------------------------------------

    Most fidelity bonds contain a definition of the term ``loss'' (or
``single loss''), for purposes of the bond, which generally includes
all covered losses resulting from any one act or a series of related
acts. A payment by an insurer for covered losses attributed to a
``single loss'' does not reduce a member's coverage amount for losses
attributed to other, separate acts. A fidelity bond with an aggregate
limit of liability caps a member's coverage during the bond period at a
certain amount if a loss (or losses) meets this aggregate threshold.
FINRA believes that per loss coverage without an aggregate limit of
liability provides firms with the most beneficial coverage since the
bond amount cannot be exhausted by one or more covered losses, so it
will be available for future losses during the bond period.
    Under proposed FINRA Rule 4360, a member's fidelity bond must
provide against loss and have Insuring Agreements covering at least the
following: fidelity, on premises, in transit, forgery and alteration,
securities and counterfeit currency. The proposed rule change modifies
the descriptive headings for these Insuring Agreements, in part, from
NASD Rule 3020(a)(1) and NYSE Rule 319(d) to align them with the
headings in the current bond forms available to broker-dealers. FINRA
has been advised by insurance industry representatives that the
proposed rule change does not substantively change what is required to
be covered by the bond.\7\
---------------------------------------------------------------------------

    \7\ For example, previous versions of the SDBB and Form 14
included a separate Insuring Agreement for misplacement; however, in
the current versions of the bonds, this coverage is included in both
``on premises'' and ``in transit'' coverage.
---------------------------------------------------------------------------

    In addition, proposed FINRA Rule 4360 would eliminate the specific
coverage provisions in NASD Rule 3020(a)(4) and (a)(5), and NYSE Rule
319(d)(ii)(B) and (C), and (e)(ii)(B) and (C), that permit less than
100 percent of coverage for certain Insuring Agreements (i.e.,
fraudulent trading and securities forgery) to require that coverage for
all Insuring Agreements be equal to 100 percent of the firm's minimum
required bond coverage. Members may elect to carry additional, optional
Insuring Agreements not required by proposed FINRA Rule 4360 for an
amount less than 100 percent of the minimum required bond coverage.
    Like NASD Rule 3020(a)(1)(H) and NYSE Rule 319.12, proposed FINRA
Rule 4360 would require that a member's fidelity bond include a
cancellation rider providing that the insurer will use its best efforts
to promptly notify FINRA in the event the bond is cancelled, terminated
or ``substantially modified.'' Also, the proposed rule change would
adopt the definition of ``substantially modified'' in NYSE Rule 319 and
would incorporate NYSE Rule 319.12's standard that a firm must
immediately advise FINRA in writing if its fidelity bond is cancelled,
terminated or substantially modified.\8\
---------------------------------------------------------------------------

    \8\ NYSE Rule 319 defines the term ``substantially modified'' as
any change in the type or amount of fidelity bonding coverage, or in
the exclusions to which the bond is subject, or any other change in
the bond such that it no longer complies with the requirements of
the rule.
---------------------------------------------------------------------------

    FINRA is proposing to add supplementary material to proposed FINRA
Rule 4360 that would require members that do not qualify for a bond
with per loss coverage without an aggregate limit of liability to
secure

alternative coverage. Specifically, a member that does not qualify for
blanket fidelity bond coverage as required by proposed FINRA Rule
4360(a)(3) would be required to maintain substantially similar fidelity
bond coverage in compliance with all other provisions of the proposed
rule, provided that the member maintains written correspondence from
two insurance providers stating that the member does not qualify for
the coverage required by proposed FINRA Rule 4360(a)(3). The member
would be required to retain such correspondence for the period
specified by Exchange Act Rule 17a-4(b)(4). FINRA has been advised by
insurance industry representatives that the proposed alternative
coverage requirement is necessary for firms that, for example, have had
a covered loss paid by an insurer within the past five years or firms
that may present certain risk factors that would prevent an insurer
from offering per loss coverage without an aggregate limit of
liability.
Minimum Required Coverage
    NASD Rule 3020 requires fidelity bond coverage for officers and
employees of a member. Under NASD Rule 3020(e), the term ``employee''
or ``employees'' means any person or persons associated with a member
firm (as defined in Article I, paragraph (rr) of the FINRA By-Laws)
except: (1) Sole proprietors, (2) sole stockholders and (3) directors
or trustees of a member who are not performing acts coming within the
scope of the usual duties of an officer or employee. Under NYSE Rule
319(a), any member organization doing business with the public must
maintain fidelity bond coverage for general partners or officers and
its employees.\9\
---------------------------------------------------------------------------

    \9\ Under NYSE Rule Interpretation 319/02 (Additional
Coverages), the required coverage of the Brokers Blanket Bond must
apply, through rider or otherwise, as applicable to: all domestic
and foreign guaranteed and non-guaranteed affiliates, subsidiaries
and branches; bearer instruments if the member organization handles
such securities; limited partners of a member firm if they are also
employees; and the partners, officers and employees or person acting
in a similar capacity of electronic data processing agencies in
their activities on behalf of the member organizations.
---------------------------------------------------------------------------

    Proposed FINRA Rule 4360, similar to NASD Rule 3020 and NYSE Rule
319, would require each member to maintain, at a minimum, fidelity bond
coverage for any person associated with the member, except directors or
trustees of a member who are not performing acts within the scope of
the usual duties of an officer or employee. As further detailed below,
the proposed rule change would eliminate the exemption in NASD Rule
3020 for sole stockholders and sole proprietors.
    The proposed rule change would increase the minimum required
fidelity bond coverage for members, while continuing to base the
coverage on a member's net capital requirement. To that end, proposed
FINRA Rule 4360 would require a member with a net capital requirement
that is less than $250,000 to maintain minimum coverage of the greater
of 120 percent of the firm's required net capital under Exchange Act
Rule 15c3-1 or $100,000. The increase to $100,000 would modify the
present minimum requirement of $25,000. FINRA believes this increase is
warranted since the NASD and NYSE fidelity bond rules have not been
materially modified since their adoption--over 30 years ago--and
$25,000 in 1974 (the year the NASD rule was adopted) is equal to
approximately $110,000 today (adjusted for inflation). Although members
may experience a slight increase in costs for their premiums under the
proposed rule change, FINRA believes that the proposed amendments to
the fidelity bond minimum requirements are necessary to provide
meaningful and practical coverage for losses covered by the bond.
    Under proposed FINRA Rule 4360, members with a net capital
requirement of at least $250,000 would use a table in the rule to
determine their minimum fidelity bond coverage requirement. The table
is a modified version of the tables in NASD Rule 3020(a)(3) and NYSE
Rule 319(e)(i). The identical NASD and NYSE requirements for members
that have a minimum net capital requirement that exceeds $1 million
would be retained in proposed FINRA Rule 4360; however, the proposed
rule would adopt the higher requirements in NYSE Rule 319(e)(i) for a
member with a net capital requirement of at least $250,000, but less
than $1 million.\10\
---------------------------------------------------------------------------

    \10\ For example, NASD Rule 3020 requires a small clearing and
carrying firm (i.e., one subject to a $250,000 net capital
requirement) to obtain $300,000 in coverage. The same firm, had it
been designated to NYSE, would have needed $600,000 in coverage.
FINRA believes the increased coverage requirements are appropriate
given the larger number/amount of claims that can be satisfied at
these levels.
---------------------------------------------------------------------------

    Under the proposed rule, the entire amount of a member's minimum
required coverage must be available for covered losses and may not be
eroded by the costs an insurer may incur if it chooses to defend a
claim. Specifically, any defense costs for covered losses must be in
addition to a member's minimum coverage requirements. A member may
include defense costs as part of its fidelity bond coverage, but only
to the extent that it does not reduce a member's minimum required
coverage under the proposed rule.
Deductible Provision
    Under NASD Rule 3020(b), a deductible provision may be included in
a member's bond of up to $5,000 or 10 percent of the member's minimum
insurance requirement, whichever is greater. If a member desires to
maintain coverage in excess of the minimum insurance requirement, then
a deductible provision may be included in the bond of up to $5,000 or
10 percent of the amount of blanket coverage provided in the bond
purchased, whichever is greater. The excess of any such deductible
amount over the maximum permissible deductible amount based on the
member's minimum required coverage must be deducted from the member's
net worth in the calculation of the member's net capital for purposes
of Exchange Act Rule 15c3-1. Where the member is a subsidiary of
another member, the excess may be deducted from the parent's rather
than the subsidiary's net worth, but only if the parent guarantees the
subsidiary's net capital in writing.
    Under NYSE Rule 319(b), each member organization may self-insure to
the extent of $10,000 or 10 percent of its minimum insurance
requirement as fixed by the NYSE, whichever is greater, for each type
of coverage required by the rule. Self-insurance in amounts exceeding
the above maximum may be permitted by the NYSE provided the member or
member organization certifies to the satisfaction of the NYSE that it
is unable to obtain greater bonding coverage, and agrees to reduce its
self-insurance so as to comply with the above stated limits as soon as
possible, and appropriate charges to capital are made pursuant to
Exchange Act Rule 15c3-1. This provision also contains identical
language to the NASD rule regarding net worth deductions for
subsidiaries.
    Proposed FINRA Rule 4360 would provide for an allowable deductible
amount of up to 25 percent of the fidelity bond coverage purchased by a
member. Any deductible amount elected by the firm that is greater than
10 percent of the coverage purchased by the member \11\ would be
deducted from the member's net worth in the calculation of its net
capital for purposes of Exchange Act Rule 15c3-1.\12\ Like the NASD and
NYSE rules, if

the member is a subsidiary of another FINRA member, this amount may be
deducted from the parent's rather than the subsidiary's net worth, but
only if the parent guarantees the subsidiary's net capital in writing.
---------------------------------------------------------------------------

    \11\ FINRA notes that a member may elect, subject to
availability, a deductible of less than 10 percent of the coverage
purchased.
    \12\ NASD Rule 3020 bases the deduction from net worth for an
excess deductible on a firm's minimum required coverage, while
proposed FINRA Rule 4360 would base such deduction from net worth on
coverage purchased by the member.
---------------------------------------------------------------------------

Annual Review of Coverage
    Consistent with NASD Rule 3020(c) and NYSE Rule 319.10, proposed
FINRA Rule 4360 would require a member (including a firm that signs a
multi-year insurance policy), annually as of the yearly anniversary
date of the issuance of the fidelity bond, to review the adequacy of
its fidelity bond coverage and make any required adjustments to its
coverage, as set forth in the proposed rule. Under proposed FINRA Rule
4360(d), a member's highest net capital requirement during the
preceding 12-month period, based on the applicable method of computing
net capital (dollar minimum, aggregate indebtedness or alternative
standard), would be used as the basis for determining the member's
minimum required fidelity bond coverage for the succeeding 12-month
period. The ``preceding 12-month period'' includes the 12-month period
that ends 60 days before the yearly anniversary date of a member's
fidelity bond. This would give a firm time to determine its required
fidelity bond coverage by the anniversary date of the bond.
    Similar to NASD Rule 3020(c)(2), proposed FINRA Rule 4360 would
allow a member that has only been in business for one year and elected
the aggregate indebtedness ratio for calculating its net capital
requirement to use, solely for the purpose of determining the adequacy
of its fidelity bond coverage for its second year, the 15 to 1 ratio of
aggregate indebtedness to net capital in lieu of the 8 to 1 ratio
(required for broker-dealers in their first year of business) to
calculate its net capital requirement. Notwithstanding the above, such
member would not be permitted to carry less minimum fidelity bond
coverage in its second year than it carried in its first year.
Exemptions
    Based in part on NASD Rule 3020(a), proposed FINRA Rule 4360 would
exempt from the fidelity bond requirements members in good standing
with a national securities exchange that maintain a fidelity bond
subject to the requirements of such exchange that are equal to or
greater than the requirements set forth in the proposed rule.\13\
Additionally, consistent with NYSE Rule Interpretation 319/01, proposed
FINRA Rule 4360 would continue to exempt from the fidelity bond
requirements any firm that acts solely as a Designated Market Maker
(``DMM''),\14\ floor broker or registered floor trader and does not
conduct business with the public.
----------------------------------------------------------


[Federal Register Volume 87, Number 190 (Monday, October 3, 2022)]
[Notices]
[Page 59813]
[FR Doc No: 2022-21353]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2021-0345]

Announcing Two Virtual Public Outreach Events

AGENCY: Coast Guard, DHS.

ACTION: Notice of outreach events.

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SUMMARY: The Coast Guard announces two virtual public outreach events
to discuss the Draft Pacific Coast Port Access Route Study (PAC-PARS)
and its recommendations to establish voluntary fairways along the
Pacific Coast. Both events will cover the same material.

FOR FURTHER INFORMATION CONTACT: For information about this document
call or email LCDR Sara Conrad, Coast Guard Pacific Area (PAC-54), U.S.
Coast Guard; telephone<PHONE_NUMBER>, email [email protected].

Public Meeting

    We plan to hold two public meetings to discuss the Draft PAC-PARS.
The first event will be held on Tuesday, October 4th at 11:00 a.m. PST.
    Please use the link below to register in advance for the October
4th event: https://www.zoomgov.com/meeting/register/vJIsfuiqrjsvGeH7UpQC 8jjrJUTR9VjyBlE.
    The second event will be held on Tuesday, October 11th at 11:00
a.m. PST.
    Please use the link below to register in advance for the October
11th event: https://www.zoomgov.com/meeting/register/vJIscu-trTIsHkwYjco9eFe VUeIqbGSHxB0.
    This notice is issued under authority of 46 U.S.C. 70003(c)(1).

    Dated: September 27, 2022.
L. Hannah,
Captain, U.S. Coast Guard, Chief, Pacific Area Preparedness Division.
[FR Doc. 2022-21353 Filed 9-30-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 222 (Monday, November 18, 2019)]
[Notices]
[Pages 63712-63713]
[FR Doc No: 2019-24988]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2019-71]

Petition for Exemption; Summary of Petition Received; Moog, Inc.

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion or omission of information in the summary
is intended to affect the legal status of the petition or its final
disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before December 9, 2019.

ADDRESSES: Send comments identified by docket number FAA-2019-0823
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.

    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jake Troutman,<PHONE_NUMBER>, Office
of Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on November 8, 2019.
Forest Rawls,
Acting Deputy Executive Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2019-0823.
    Petitioner: Moog, Inc.
    Sections of 14 CFR Affected: Sec. Sec.  107.3 & 61.3(a)(1)(i).
    Description of Relief Sought: The proposed exemption, if granted,
would allow the petitioner relief so the pilot in command of their MACH
2p2 unmanned aircraft system, that weighs more than 55 pounds, can hold
a part 107 remote pilot certificate, rather than an airline transport,
commercial, private, recreational, or sport pilot certificate. The
proposed operation is for research and development, during daylight
hours, within visual line of sight, below 400 feet above ground level,
and within Class G airspace.

[FR Doc. 2019-24988 Filed 11-15-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 9 (Friday, January 12, 2018)]
[Notices]
[Pages 1619-1620]
[FR Doc No: 2018-00418]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6380]

Clarification of Orphan Designation of Drugs and Biologics for
Pediatric Subpopulations of Common Diseases; Draft Guidance for
Industry; Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is extending
the comment period for the notice of availability that appeared in the
Federal Register of December 20, 2017. In the notice of availability,
FDA requested comments on the draft guidance for industry entitled
``Clarification of Orphan Designation of Drugs and Biologics for
Pediatric Subpopulations of Common Diseases.'' The Agency is taking
this action in response to public interest in the draft guidance and to
allow interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the notice of
availability published December 20, 2017 (82 FR 60402). Submit either
electronic or written comments on the draft guidance by February 18,
2018, to ensure that the Agency considers your comment on this draft
guidance before it begins work on the final version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-6380 for ``Clarification of Orphan Designation of Drugs and
Biologics for Pediatric Subpopulations of Common Diseases.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Aaron Friedman, Office of Orphan
Products Development, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5295, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 20,
2017, FDA published a notice of availability with a 30-day comment
period to request comments on the draft guidance for industry entitled
``Clarification of Orphan Designation of Drugs and Biologics for
Pediatric Subpopulations of Common Diseases.''
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on orphan
designation of drugs and biologics for pediatric subpopulations of
common diseases. It does not establish any rights for any person and is
not binding on FDA or the public. You can

use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This draft guidance is not subject
to Executive Order 12866.
    Based on public interest in the draft guidance, FDA is extending
the comment period for the notice of availability for 30 days, until
February 28, 2018. The Agency believes that a 30-day extension allows
adequate time for interested persons to submit comments without
significantly delaying guidance on these important issues.

    Dated: January 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00418 Filed 1-11-18; 8:45 am]
BILLING CODE 4164-01-P