[Federal Register Volume 75, Number 239 (Tuesday, December 14, 2010)]
[Notices]
[Pages 77925-77926]
[FR Doc No: 2010-31230]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63461; File No. SR-BX-2010-085]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Establish
Strike Price Intervals and Trading Hours for Options on Index-Linked
Securities

December 8, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on December 2, 2010, NASDAQ OMX BX, Inc. (the ``Exchange'') filed
with the Securities and Exchange Commission (the ``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend the Supplementary Material to
Chapter IV, Section 6 (Series of Options Contracts Open for Trading)
and Chapter V, Section 3 (Days and Hours of Business) of the Rules of
the Boston Options Exchange Group, LLC (``BOX'') to establish strike
price intervals and trading hours for options on Index-Linked
Securities. The text of the proposed rule change is available from the
principal office of the Exchange, on the Commission's Web site at
http://www.sec.gov, at the Commission's Public Reference Room, and on
the Exchange's Web site at http://nasdaqomxbx.cchwallstreet.com/NASDAQOMXBX/Filings/.

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

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

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

1. Purpose
    Prior to the commencement of trading options on Index-Linked
Securities on BOX, the Exchange is proposing to establish strike price
intervals and trading hours for these products.
    The Securities and Exchange Commission (the ``Commission'') has
approved BOX's and other option exchanges' proposals to enable the
listing and trading of options on Index-Linked Securities.\3\ BOX has
not commenced trading options on Index-Linked Securities to date.
Trading in options on Index-Linked Securities has commenced on other
exchanges following the Commission's approval of The Options Clearing
Corporation's (``OCC'') May 2010 supplement to the Options Disclosure
Document (``ODD'') that provides disclosure regarding options on Index-
Linked Securities.\4\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release Nos. 58941 (Nov. 13,
2008), 73 FR 70392 (Nov. 20, 2008) (SR-BSE-2008-50); 58985 (Nov. 10,
2008), 73 FR 72538 (Nov. 28, 2008) (SR-ISE-2008-86); 58204 (July 22,
2008), 73 FR 43807 (July 28, 2008) (SR-CBOE-2008-64); and 58203
(July 22, 2008), 73 FR 43812 (July 28, 2008) (SR-NYSEArca-2008-57).
    \4\ OCC previously received Commission approval to clear options
based on Index-Linked Securities. See Securities Exchange Act
Release No. 60872 (Oct. 23, 2009), 74 FR 55878 (Oct. 29, 2009) (SR-
OCC-2009-14).
---------------------------------------------------------------------------

$1 Strikes for Options on Index-Linked Securities
    Prior to the commencement of trading on BOX of options on Index-
Linked Securities that satisfy the criteria set forth in Chapter IV,
Section 3(k) of the BOX Rules, the Exchange is proposing to establish
that strike price intervals of $1 will be permitted where the strike
price is less than $200. Where the strike price is greater than $200,
$5 strikes will be permitted. These proposed changes are reflected by
the proposed addition of Supplementary Material .01(c) to Chapter IV,
Section 6 of the BOX Rules.
    Without discounting the differences between exchange-traded funds
(``ETFs'') and Index-Linked Securities, BOX seeks to extend the trading
conventions applicable to options on ETFs to options on Index-Linked
Securities. BOX contends that the proposed strike price intervals for
options on Index-Linked Securities are consistent with the strike price
intervals currently permitted for options on ETFs. BOX believes that $1
strike price intervals for options on Index-Linked Securities will
provide investors with greater flexibility by allowing them to
establish positions that are better tailored to meet their investment
objectives. BOX has analyzed its capacity and represents that it and
the Options Price Reporting Authority have the necessary systems
capacity to handle the additional traffic associated with the listing
and trading of an expanded number of series as proposed by this filing.
Trading Hours for Options on Index-Linked Securities
    Similar to the trading hours for ETF options, the Exchange proposes
to amend Chapter V, Section 3(b) of the BOX Rules to provide that
options on Index-Linked Securities may be traded on BOX until 4:15 p.m.
each business day.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of the Securities and Exchange Act of 1934 (``Exchange
Act''), in general, and Section 6(b)(5) of the Exchange Act,\5\ in
particular, that an exchange has rules that are designed to promote
just and equitable principles of trade, and to remove impediments to
and perfect the mechanism for a free and open market and a national
market system and, in general, to protect investors and the public
interest. In particular, the Exchange believes the proposal will lessen
investor confusion by having strike price intervals and trading hours
established prior to the commencement of trading on BOX of options on
Index-Linked Securities.
---------------------------------------------------------------------------

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

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

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

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

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

    The Exchange has neither solicited nor received comments on the
proposed rule change.

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

    Because the foregoing proposed rule change does not significantly
affect the protection of investors or the public interest, does not
impose any significant burden on competition, and, by its terms, does
not become operative for 30 days from the date on which it was filed,
or such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \6\ and Rule 19b-
4(f)(6) thereunder.\7\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied the five-day pre-filing requirement.
---------------------------------------------------------------------------

    The Exchange has requested that the Commission waive the 30-day
operative delay. The Commission believes that waiver of the operative
delay is consistent with the protection of investors and the public
interest because the proposal is substantially similar to that of
another exchange that has been approved by the Commission.\8\
Therefore, the Commission designates the proposal operative upon
filing.\9\
---------------------------------------------------------------------------

    \8\ See Securities and Exchange Act Release No. 61696 (March 12,
2010), 75 FR 13174 (March 18, 2010) (SR-CBOE-2010-005).
    \9\ For purposes only of waiving the 30-day operative delay, the
Commission has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BX-2010-085 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BX-2010-085. 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 Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-BX-2010-085 and should be
submitted on or before January 4, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-31230 Filed 12-13-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 134 (Friday, July 12, 2013)]
[Notices]
[Pages 41934-41937]
[FR Doc No: 2013-16692]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection;
Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based
Products: Establishment Registration and Listing; Form FDA 3356;
Eligibility Determination for Donors; and Current Good Tissue Practice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
requirements for FDA regulations related to human cells, tissues, and
cellular and tissue-based products (HCT/Ps) involving establishment
registration and listing using Form FDA 3356; eligibility determination
for donors; and current good tissue practice (CGTP).

DATES: Submit either electronic or written comments on the collection
of information by September 10, 2013.

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: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

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

Human Cells, Tissues, and Cellular and Tissue-Based Products:
Establishment Registration and Listing; Form FDA 3356; Eligibility
Determination for Donors; and Current Good Tissue Practice--(OMB
Control Number 0910-0543)--Extension

    Under section 361 of the Public Health Service Act (the PHS Act)
(42 U.S.C. 264), FDA may issue and enforce regulations necessary to
prevent the introduction, transmission, or spread of communicable
diseases between the States or possessions or from foreign countries
into the States. As derivatives of the human body, all HCT/Ps pose some
risk of carrying pathogens that could potentially infect recipients or
handlers. FDA has issued regulations related to HCT/Ps involving
establishment registration and listing using Form FDA 3356, eligibility
determination for donors, and CGTP.

A. Establishment Registration and Listing; Form FDA 3356

    The regulations in part 1271 (21 CFR part 1271) require domestic
and foreign establishments that recover, process, store, label,
package, or distribute an HCT/P described in Sec.  1271.10(a), or that
perform screening or testing of the cell or tissue donor to register
with FDA (Sec.  1271.10(b)(1)) and submit a list of each HCT/P
manufactured (Sec.  1271.10(b)(2)). Section 1271.21(a) requires an
establishment to follow certain procedures for initial registration and
listing of HCT/Ps, and Sec.  1271.25(a) and (b) identifies the required
initial registration and HCT/P listing information. Section 1271.21(b),
in brief, requires an annual update of the establishment registration.
Section 1271.21(c)(ii) requires establishments to submit HCT/P listing
updates if a change as described in Sec.  1271.25(c) has occurred.
Section 1271.25(c) identifies the required HCT/P listing update
information. Section 1271.26 requires establishments to submit an
amendment if ownership or location of the establishment changes. FDA
requires the use of a registration and listing form (Form FDA 3356:
Establishment Registration and Listing for Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps)) to submit the required
information (Sec. Sec.  1271.10, 1271.21, 1271.25, and 1271.26)). To
further facilitate the ease and speed of submissions, electronic
submission is accepted (http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/TissueEstablishmentRegistration/default.htm).

B. Eligibility Determination for Donors

    In brief, FDA requires certain HCT/P establishments described in
Sec.  1271.1(b) to determine donor eligibility based on donor screening
and testing for relevant communicable disease agents and diseases
except as provided under Sec.  1271.90. The documented determination of
a donor's eligibility is made by a responsible person as defined in
Sec.  1271.3(t) and is based on the results of required donor
screening, which includes a donor medical history interview (defined in
Sec.  1271.3(n)), and testing (Sec.  1271.50(a)). Certain records must
accompany an HCT/P once the donor-eligibility determination has been
made (Sec.  1271.55(a)). This requirement applies both to an HCT/P from
a donor who is determined to be eligible as well as to an HCT/P from a
donor who is determined to be ineligible or where the donor-eligibility
determination is not complete if there is a documented

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

C. Current Good Tissue Practice (CGTP)

    FDA requires HCT/P establishments to follow CGTP (Sec.  1271.1(b)).
Section 1271.155(a) permits the submission of a request for FDA
approval of an exemption from or an alternative to any requirement in
subpart C or D of part 1271. Section 1271.290(c) requires
establishments to affix a distinct identification code to each HCT/P
that they manufacture that relates the HCT/P to the donor and to all
records pertaining to the HCT/P. Whenever an establishment distributes
an HCT/P to a consignee, Sec.  1271.290(f) requires the establishment
to inform the consignee, in writing, of the product tracking
requirements and the methods the establishment uses to fulfill these
requirements. Non-reproductive HCT/P establishments described in Sec.
1271.10 are required under Sec.  1271.350(a)(1) and (a)(3) to
investigate and report to FDA adverse reactions (defined in Sec.
1271.3(y)) using Form FDA-3500A (Sec.  1271.350(a)(2)). Form FDA-3500A
is approved under OMB Control No. 0910-0291. Section 1271.370(b) and
(c) requires establishments to include specific information either on
the HCT/P label or with the HCT/P.
    The standard operating procedures (SOPs) provisions under part 1271
include the following: (1) Section 1271.160(b)(2) (receiving,
investigation, evaluating, and documenting information relating to core
CGTP requirements, including complaints, and for sharing information
with consignees and other establishments); (2) Sec.  1271.180(a) (to
meet core CGTP requirements for all steps performed in the manufacture
of HCT/Ps); (3) Sec.  1271.190(d)(1) (facility cleaning and
sanitization); (4) Sec.  1271.200(b) (cleaning, sanitizing, and
maintenance of equipment); (5) Sec.  1271.200(c) (calibration of
equipment); (6) Sec.  1271.230(a) and (c) (validation of a process and
review and evaluation of changes to a validated process); (7) Sec.
1271.250(a) (controls for labeling HCT/Ps); (8) Sec.  1271.265(e)
(receipt, predistribution shipment, availability for distribution, and
packaging and shipping of HCT/Ps); (9) Sec.  1271.265(f) (suitable for
return to inventory); (10) Sec.  1271.270(b) (records management
system); (11) Sec.  1271.290(b)(1) (system of HCT/P tracking); and (12)
Sec.  1271.320(a) (review, evaluation, and documentation of complaints
as defined in Sec.  1271.3(aa)).
    Section 1271.155(f) requires an establishment operating under the
terms of an exemption or alternative to maintain documentation of FDA's
grant of the exemption or approval and the date on which it began
operating under the terms of the exemption or alternative. Section
1271.160(b)(3) requires the quality program of an establishment that
performs any step in the manufacture of HCT/Ps to document corrective
actions relating to core CGTP requirements. Section 1271.160(b)(6)
requires documentation of HCT/P deviations. Section 1271.160(d)
requires, in brief, documentation of validation of computer software if
the establishment relies upon it to comply with core CGTP requirements.
Section 1271.190(d)(2) requires documentation of all cleaning and
sanitation activities performed to prevent contamination of HCT/Ps.
Section 1271.195(d) requires documentation of environmental control and
monitoring activities. Section 1271.200(e) requires documentation of
all equipment maintenance, cleaning, sanitizing, calibration, and other
activities. Section 1271.210(d) requires, in brief, documentation of
the receipt, verification, and use of each supply or reagent. Section
1271.230(a) requires documentation of validation activities and results
when the results of processing described in Sec.  1271.220 cannot be
fully verified by subsequent inspection and tests. Section 1271.230(c)
requires that when changes to a validated process subject to
1271.230(a) occur, documentation of the review and evaluation of the
process and revalidation, if necessary, must occur. Section 1271.260(d)
and (e) requires documentation of any corrective action taken when
proper storage conditions are not met and documentation of the storage
temperature for HCT/Ps. Section 1271.265(c)(1) requires documentation
that all release criteria have been met before distribution of an HCT/
P. Section 1271.265(c)(3) requires documentation of any departure from
a procedure relevant to preventing risks of communicable disease
transmission at the time of occurrence. Section 1271.265(e) requires
documentation of

the activities in paragraphs (a) through (d) of this section, which
must include identification of the HCT/P and the establishment that
supplied the HCT/P, activities performed and the results of each
activity, date(s) of activity, quantity of HCT/P subject to the
activity, and disposition of the HCT/P. Section 1271.270(a) requires
documentation of each step in manufacturing required in part 1271,
subparts C and D. Section 1271.270(e) requires documentation of the
name and address, and a list of responsibilities of any establishment
that performs a manufacturing step for the establishment. Section
1271.290(d) and (e) require documentation of a method for recording the
distinct identification code and type of each HCT/P distributed to a
consignee to enable tracking from the consignee to the donor and to
enable tracking from the donor to the consignee or final disposition.
Section 1271.320(b) requires an establishment to maintain a record of
each complaint that it receives. The complaint file must contain
sufficient information about each complaint for proper review and
evaluation of the complaint and for determining whether the complaint
is an isolated event or represents a trend.
    Respondents to this information collection are establishments that
recover, process, store, label, package or distribute any HCT/P, or
perform donor screening or testing. The estimates provided below are
based on most recent available information from FDA's database system
and trade organizations. The hours per response and hours per record
are based on data provided by the Eastern Research Group, or FDA
experience with similar recordkeeping or reporting requirements.
    There are an estimated 2,706 HCT/P establishments (conventional
tissue, eye tissue, peripheral blood stem cell, stem cell products from
cord blood, reproductive tissue, and sperm banks), including 741
manufacturers of HCT/P products regulated under the Federal Food, Drug,
and Cosmetic Act and section 351 of the PHS Act (42 U.S.C. 262), that
have registered and listed with FDA. In addition, we estimate that 218
new establishments have registered with FDA (Sec. Sec.  1271.10(b)(1)
and (b)(2) and 1271.25(a) and (b)). There are an estimated 3,737
listing updates (Sec. Sec.  1271.10(b)(2), 1271.21(c)(2)(ii), and
1271.25(c)) and 1,222 location/ownership amendments (Sec.  1271.26).
    Under Sec.  1271.55(a), an estimated total of 2,167,396 HCT/Ps
(which include conventional tissues, eye tissues, hematopoetic stem
cells/progenitor cells, and reproductive cells and tissues), and an
estimated total of 2,026,861 non-reproductive cells and tissues (total
HCT/Ps minus reproductive cells and tissues) are distributed per year
by an estimated 1,965 establishments (2,706 - 741 = 1,965)
establishments with approved applications).
    Under Sec.  1271.60(c) and (d)(2), FDA estimates that 1,375
establishments shipped an estimated 286,000 HCT/P under quarantine, and
that an estimated 26 establishments requested 40 exemptions from or
alternative to any requirement under part 1271, subpart C or D,
specifically under Sec.  1271.155(a).
    Under Sec. Sec.  1271.290(c) and 1271.370(b) and (c), the estimated
1,694 non-reproductive HCT/P establishments label each of their
2,026,861 HCT/Ps with certain information. These establishments are
also required to inform their consignees in writing of the requirements
for tracking and of their established tracking system under Sec.
1271.290(f).
    FDA estimates 24 HCT/P establishments submitted 206 adverse
reaction reports with 167 involving a communicable disease (Sec.
1271.350(a)(1)).
    FDA estimates that 218 new establishments will create SOPs, and
that 2,706 establishments will review and revise existing SOPs
annually.
    FDA estimates that 1,353 HCT/P establishments (2,706 x 50% = 1,353)
and 847 non-reproductive HCT/P establishments (1,694 x 50% = 847)
record and justify a departure from the procedures (Sec. Sec.
1271.47(d) and 1271.265(c)(3)).
    Under Sec.  1271.50(a), HCT/P establishments are required to have a
documented medical history interview about the donor's medical history
and relevant social behavior as part of the donor's relevant medical
records for each of the estimated total of 91,756 donors (which include
conventional tissue donors, eye tissue donors, peripheral and cord
blood stem cell donors, and reproductive cell and tissue donors), and
the estimated total of 86,156 non-reproductive cells and tissue donors
(total donors minus reproductive cell and tissue donors).
    FDA estimates that 812 HCT/P establishments (2,706 x 30% = 812)
document an urgent medical need of the product to notify the physician
using the HCT/P (Sec. Sec.  1271.60(d)(3) and 1271.65(b)(3)).
    FDA also estimates that 2,165 HCT/P establishments (2,706 x 80% =
2,165) have to maintain records for an average of 2 contract
establishments to perform their manufacturing process (Sec.
1271.270(e) and 1,353 HCT/P establishments maintain an average of 5
complaint records annually (Sec.  1271.320(b)).
    In some cases, the estimated burden may appear to be lower or
higher than the burden experienced by individual establishments. The
estimated burden in these charts is an estimated average burden, taking
into account the range of impact each regulation may have.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
        21 CFR Section             Number of    responses  per   Total annual    Average burden     Total hours
                                  respondents      respondent      responses      per response
----------------------------------------------------------------------------------------------------------------
1271.10(b)(1) and 1271.21(b)             2,706               1           2,706  .5 (30 minutes).           1,353
 \2\.
1271.10(b)(1) and (b)(2),                  218               1             218  .75 (45 minutes)             164
 1271.21(a), and 1271.25(a)
 and (b) \2\.
1271.10(b)(2),                           3,737               1           3,737  .5 (30 minutes).           1,869
 1271.21(c)(2)(ii) and
 1271.25(c) \2\.
1271.26 \2\...................           1,222               1           1,222  .25 (15 minutes)             306
1271.155(a)...................              26            1.54              40  3...............             120
1271.350(a)(1) and (a)(3).....              24            8.58             206  1...............             206
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           4,018
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Using Form FDA 3356.

                                Table 2--Estimated Annual Recordkeeping Burden 1
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average burden
        21 CFR Section             Number of      records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeper
----------------------------------------------------------------------------------------------------------------
New SOPs \2\..................             218               1             218  48..............          10,464
SOP Update \2\................           2,706               1           2,706  24..............          64,944
1271.47(d)....................           1,353               1           1,353  1...............           1,353
1271.50(a)....................           2,706           33.91          91,756  5...............         458,780
1271.55(d)(1).................           2,706           33.91          91,756  1...............          91,756
1271.55(d)(2).................           2,706               1           2,706  1...............           2,706
1271.55(d)(4).................           2,706               1           2,706  120.............         324,720
1271.60(d)(3) and (d)(4)                   812               1             812  2...............           1,624
 1271.65(b)(3)(iii).
1271.155(f)...................              26            1.54              40  .25 (15 minutes)              10
1271.160(b)(3) and (b)(6).....           1,694              12          20,328  1...............          20,328
1271.160(d)...................           1,694              12          20,328  1...............          20,328
1271.190(d)(2)................           1,694              12          20,328  1...............          20,328
1271.195(d)...................           1,694              12          20,328  1...............          20,328
1271.200(e)...................           1,694              12          20,328  1...............          20,328
1271.210(d)...................           1,694              12          20,328  1...............          20,328
1271.230(a)...................           1,694              12          20,328  1...............          20,328
1271.230(c)...................           1,694               1           1,694  1...............           1,694
1271.260(d)...................           1,694              12          20,328  .25 (15 minutes)           5,082
1271.260(e)...................           1,694             365         618,310  .083 (5 minutes)          51,320
1271.265(c)(1)................           1,694        1,196.49       2,026,861  .083 (5 minutes)         168,229
1271.265(c)(3)................             847               1             847  1...............             847
1271.265(e)...................           1,694        1,196.49       2,026,861  .083 (5 minutes)         168,229
1271.270(a)...................           1,694        1,196.49       2,026,861  .25 (15 minutes)         506,715
1271.270(e)...................           2,165               2           4,330  .5 (30 minutes).           2,165
1271.290(d) and (e)...........           1,694           50.86          86,156  .25 (15 minutes)          21,539
1271.320(b)...................           1,353               5           6,765  1...............           6,765
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................       2,031,238
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Sections 1271.47(a), 1271.85(b)(2), 1271.160(b)(2) and (d)(1), 1271.180(a), 1271.190(d)(1), 1271.200(b),
  1271.200(c), 1271.230(a), 1271.250(a), and 1271.265(e).

                            Table 1--Estimated Annual Third-Party Disclosure Burden 1
----------------------------------------------------------------------------------------------------------------
                                                   Number of
        21 CFR Section             Number of      disclosures    Total annual    Average burden     Total hours
                                  respondents   per respondent    disclosures    per  disclosure
----------------------------------------------------------------------------------------------------------------
1271.55(a)....................           1,965           1,103       2,167,396  .5 (30 minutes).       1,083,698
1271.60(c) and (d)(2).........           1,375             208         286,000  .5 (30 minutes).         143,000
1271.290(c)...................           1,694        1,196.49       2,026,861  .083 (5 minutes)         168,229
1271.290(f)...................           1,694               1           1,694  1...............           1,694
1271.370(b) and (c)...........           1,694        1,196.49       2,026,861  .25 (15 minutes)         506,715
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................       1,903,336
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: July 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16692 Filed 7-11-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 176 (Tuesday, September 11, 2012)]
[Proposed Rules]
[Page 55787]
[FR Doc No: 2012-22298]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket ID FEMA-2008-0020; Internal Agency Docket No. FEMA-B-1066]

Proposed Flood Elevation Determinations for Hampden County, MA,
and Incorporated Areas

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Proposed rule; withdrawal.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) is withdrawing
its proposed rule concerning proposed flood elevation determinations
for Hampden County, Massachusetts, and Incorporated Areas.

DATES: This withdrawal is effective on September 11, 2012.

ADDRESSES: You may submit comments, identified by Docket No. FEMA-B-
1066, to Luis Rodriguez, Chief, Engineering Management Branch, Federal
Insurance and Mitigation Administration, Federal Emergency Management
Agency, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
Federal Emergency Management Agency, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On September 8, 2009, FEMA published a
proposed rulemaking at 74 FR 46047, proposing flood elevation
determinations along one or more flooding sources in Hampden County,
Massachuhsetts. FEMA is withdrawing the proposed rulemaking and intends
to publish a Notice of Proposed Flood Hazard Determinations in the
Federal Register and a notice in the affected community's local
newspaper following issuance of a revised preliminary Flood Insurance
Rate Map and Flood Insurance Study report.

    Authority: 42 U.S.C. 4104; 44 CFR 67.4.

    Dated: September 3, 2012.
Sandra K. Knight,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2012-22298 Filed 9-10-12; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register: September 8, 2009 (Volume 74, Number 172)]
[Notices]
[Page 46283-46285]
[DOCID:fr08se09-148]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60592; File No. SR-BX-2009-050]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Modify
Fees for Members Using the NASDAQ OMX BX Equities System

August 31, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on August 17, 2009, NASDAQ OMX BX, Inc. (``BX'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change as described in Items I, II, and III below, which Items have
been prepared by the Exchange. The Commission is publishing this notice
to solicit comments on the proposed rule from interested persons.
---------------------------------------------------------------------------

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

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

    BX is filing a proposed rule change to modify pricing for BX
members using the NASDAQ OMX BX Equities System. BX will implement the
proposed rule change on September 1, 2009. The text of the proposed
rule change is attached as Exhibit 5 and is available at http://
nasdaqomxbx.cchwallstreet.com.\3\
---------------------------------------------------------------------------

    \3\ The Commission notes that Exhibit 5 is attached to the rule
filing filed with the Commission but not to this release. The text
of the proposed rule change is available at BX, on its Web site
(http://nasdaqomxbx.cchwallstreet.com), 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, BX 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. BX 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
    BX is proposing to modify its fees to execute transactions on the
NASDAQ OMX BX Equities System.\4\ For securities listed on The NASDAQ
Stock Market (``NASDAQ'') or the New York Stock Exchange (``NYSE''), BX
currently provides a credit of $0.0006 per share executed to members
accessing liquidity, with no charge or credit to members providing
liquidity. Under the modified fee schedule, BX will lower the credit
for accessing liquidity to $0.0001 per share executed and assess a
charge of $0.0003 per share executed to members providing liquidity.
Although the change will result in a small fee increase, the fee change
is designed to continue BX's strategy of becoming a preferred routing
destination for firms seeking to access liquidity at extremely low cost
and a preferred market for firms that wish to post liquidity in a venue
to which growing numbers of firms route. The change also reverses an
``inverted'' fee structure in which rebates associated with the
execution of an order exceeded charges.
---------------------------------------------------------------------------

    \4\ The changes all relate to transactions that execute at
prices of $1 or more. For transactions at prices below $1, there is
a charge of 0.1% of total transaction cost to remove liquidity and
no charge or rebate to provide liquidity.
---------------------------------------------------------------------------

    For securities other than those listed on NASDAQ and NYSE, BX
currently charges a fee of $0.0014 per share executed to access
liquidity and provides a credit of $0.002 per share executed for
providing liquidity. Under the modified fee schedule, BX will raise the
fee to access liquidity to $0.0016 and lower the liquidity provider
credit to $0.0014. Although the change will result in a small fee
increase, the level of fees is consistent with BX's goal of offering
liquidity at extremely low cost to investors, and also reverses an
inverted fee structure.
2. Statutory Basis
    BX believes that the proposed rule change is consistent with the
provisions of Section 6 of the Act,\5\ in general, and with Section
6(b)(4) of the Act,\6\ in particular, in that it provides for the
equitable allocation of reasonable dues, fees and other charges among
members and issuers and other persons using any facility or system
which BX operates or controls. The proposed fee change applies
uniformly to all BX members. The impact of the changes upon the net
fees paid by a particular market participant will depend upon the types
of stocks that it trades, the order types that it uses, and the prices
of its quotes and orders (i.e., its propensity to add or remove
liquidity). BX notes that it operates in a highly competitive market in
which market participants can readily direct order flow to competing
venues if they deem fee levels at a particular venue to be excessive.
The proposed changes will continue BX's goal of allowing members to
access available liquidity at extremely low cost.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f.
    \6\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    BX does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \7\ and subparagraph (f)(2) of Rule 19b-4
thereunder.\8\ At any time within 60 days of the filing of the proposed
rule change, the Commission may summarily abrogate such rule change if
it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(a)(ii).
    \8\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BX-2009-050 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BX-2009-050. 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 the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make publicly available. All
submissions should refer to File Number SR-BX-2009-050 and should be
submitted on or before September 29, 2009.
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).

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

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-21635 Filed 9-4-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 199 (Tuesday, October 19, 2021)]
[Rules and Regulations]
[Pages 57751-57753]
[FR Doc No: 2021-22510]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 86, No. 199 / Tuesday, October 19, 2021 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0837; Project Identifier MCAI-2021-00762-R;
Amendment 39-21756; AD 2021-20-18]
RIN 2120-AA64

Airworthiness Directives; Leonardo S.p.a. Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain serial-numbered Leonardo S.p.a. Model AW119 MKII helicopters.
This AD was prompted by the discovery that the passenger cabin windows
(windows) on a batch of helicopters were improperly installed during
production. This AD requires removing and reinstalling the windows. The
FAA is issuing this AD to address the unsafe condition on these
products.

DATES: This AD becomes effective November 3, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain document listed in this AD as of November 3,
2021.
    The FAA must receive comments on this AD by December 3, 2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this final rule, contact
Leonardo S.p.A. Helicopters, Emanuele Bufano, Head of Airworthiness,
Viale G.Agusta 520, 21017 C.Costa di Samarate (Va) Italy; telephone
+39-0331-225074; fax +39-0331-229046; or at https://customerportal.leonardocompany.com/en-US/. You may view this service
information at the FAA, Office of the Regional Counsel, Southwest
Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For
information on the availability of this material at the FAA, call (817)
222-5110. It is also available at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0837.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0837; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, the
European Aviation Safety Agency (now European Union Aviation Safety
Agency) (EASA) AD, any comments received, and other information. The
street address for Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Kristi Bradley, Program Manager, COS
Program Management Section, Operational Safety Branch, Compliance &
Airworthiness Division, FAA, 10101 Hillwood Pkwy., Fort Worth, TX
76177; telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2018-0270, dated December 12, 2018
(EASA AD 2018-0270), to correct an unsafe condition for Leonardo S.p.A.
Helicopters, formerly Finmeccanica S.p.A., AgustaWestland S.p.A.,
Agusta S.p.A.; and AgustaWestland Philadelphia Corporation, formerly
Agusta Aerospace Corporation, Model AW119MKII helicopters, serial
numbers 14831, 14834, 14838, 14840, 14841, 14842, 14843, 14844, 14901,
14904, 14905, 14906, and 14918. EASA advises that during maintenance of
a helicopter, removal of passenger windows could only be accomplished
with difficulty. EASA further advises that subsequent investigation
identified a batch of helicopters on which passenger windows have been
improperly installed during production. According to Leonardo
Helicopters service information, an investigation concluded that the
gasket was bonded to the window (or on both sides) instead of to the
door frame.
    This condition, if not corrected, could prevent the jettisoning of
the windows, possibly preventing the evacuation of passengers during an
emergency situation. Accordingly, EASA AD 2018-0270 requires removal
and reinstallation of the passenger windows with the approved design
data.

FAA's Determination

    The applicable model helicopter has been approved by EASA and is
approved for operation in the United States. Pursuant to the FAA's
bilateral agreement with the European Union, EASA has notified the FAA
about the unsafe condition described in its AD. The FAA is issuing this
AD after evaluating all known relevant information and determining that
the unsafe condition described previously is likely to exist or develop
on other helicopters of the same type design.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Leonardo Helicopters Alert Service Bulletin No.
119-094, dated November 15, 2018. This service information specifies
procedures for removing the standard windows installed on the affected
helicopters and reinstalling them in accordance with approved design
data.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

AD Requirements

    This AD requires, within 100 hours time-in-service after the
effective date of this AD, removing and reinstalling the left-hand and
right-hand windows by following certain procedures in the service
information.

Differences Between This AD and the EASA AD

    EASA AD 2018-0270 requires discarding certain seal fillers and
gaskets, whereas this AD requires removing those parts from service
instead.

Justification for Immediate Adoption and Determination of the Effective
Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency, for ``good cause,'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules effective in less than thirty days,
upon a finding of good cause.
    There are no helicopters with this type certificate on the U.S.
Registry. Accordingly, notice and opportunity for prior public comment
are unnecessary, pursuant to 5 U.S.C. 553(b)(3)(B). In addition, for
the foregoing reasons, the FAA finds that good cause exists pursuant to
5 U.S.C. 553(d) for making this amendment effective in less than 30
days.

Comments Invited

    The FAA invites you to send any written data, views, or arguments
about this final rule. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2021-0837; Project Identifier MCAI-
2021-00762-R'' at the beginning of your comments. The most helpful
comments reference a specific portion of the final rule, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this final rule.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this AD, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this AD. Submissions containing CBI should be sent to Kristi
Bradley, Program Manager, COS Program Management Section, Operational
Safety Branch, Compliance & Airworthiness Division, FAA, 10101 Hillwood
Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
[email protected]. Any commentary that the FAA receives which is
not specifically designated as CBI will be placed in the public docket
for this rulemaking.

Regulatory Flexibility Act

    The requirements of the Regulatory Flexibility Act (RFA) do not
apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt
a rule without prior notice and comment. Because the FAA has determined
that it has good cause to adopt this rule without prior notice and
comment, RFA analysis is not required.

Costs of Compliance

    There are no costs of compliance with this AD because there are no
helicopters with this type certificate on the U.S. Registry.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have 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.
    For the reasons discussed, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2021-20-18 Leonardo S.p.a.: Amendment 39-21756; Docket No. FAA-2021-
0837; Project Identifier MCAI-2021-00762-R.

(a) Effective Date

    This airworthiness directive (AD) is effective November 3, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Leonardo S.p.a. Model AW119 MKII helicopters,
certificated in any category, with serial number 14831, 14834,
14838, 14840, 14841, 14842, 14843, 14844, 14901, 14904, 14905,
14906, or 14918.

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 5620, Passenger
compartment doors.

(e) Unsafe Condition

    This AD was prompted by the discovery of improperly installed
passenger cabin windows (windows). The FAA is issuing this AD to
ensure that each window is properly installed and opens properly.
The unsafe condition, if not addressed, could result in

occupants not being able to exit the helicopter during an emergency
situation.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    Within 100 hours time in service after the effective date of
this AD, replace the left-hand and right-hand windows by following
the Accomplishment Instructions, paragraphs 2. and 3., of Leonardo
Helicopters Alert Service Bulletin No. 119-094, dated November 15,
2018 (ASB119-094), except where ASB 119-094 specifies to discard the
seal filler and gasket, remove those parts from service.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (i)(1) of
this AD. Information may be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(i) Related Information

    (1) For more information about this AD, contact Kristi Bradley,
Program Manager, COS Program Management Section, Operational Safety
Branch, Compliance & Airworthiness Division, FAA, 10101 Hillwood
Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
[email protected].
    (2) The subject of this AD is addressed in European Aviation
Safety Agency (now European Union Aviation Safety Agency) (EASA) AD
2018-0270, dated December 12, 2018. You may view the EASA AD at
https://www.regulations.gov in Docket No. FAA-2021-0837.

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Leonardo Helicopters Alert Service Bulletin No. 119-094,
dated November 15, 2018.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Leonardo S.p.A. Helicopters, Emanuele Bufano, Head of Airworthiness,
Viale G.Agusta 520, 21017 C.Costa di Samarate (Va) Italy; telephone
+39-0331-225074; fax +39-0331-229046; or at https://customerportal.leonardocompany.com/en-US/.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email: [email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on September 23, 2021.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021-22510 Filed 10-18-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 71 (Friday, April 12, 2013)]
[Notices]
[Page 21929]
[FR Doc No: 2013-08602]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AC13-63-000]

TexStar Crude Oil Pipeline, LP; Notice of Filing

    Take notice that on March 26, 2013, TexStar Crude Oil Pipeline, LP
(TexStar) submitted to the Federal Energy Regulatory Commission
(Commission) a request for waiver of the reporting requirement to file
the 2012 FERC Form No. 6, Annual Report of Oil Pipeline Companies.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 or 385.214). 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. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is 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 email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on May 3, 2013.

    Dated: April 3, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-08602 Filed 4-11-13; 8:45 am]
BILLING CODE 6717-01-P