[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Pages 23080-23083]
[FR Doc No: 2017-10129]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80674; File No. SR-ICEEU-2017-007]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Proposed Rule Change, Security-Based Swap Submission or Advance
Notice Relating to Amendments to the ICE Clear Europe Limited Articles
of Association

May 15, 2017
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 2, 2017, ICE Clear Europe Limited (``ICE Clear Europe'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule changes described in Items I, II, and III below, which
Items have been prepared primarily by ICE Clear Europe. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change, Security-Based Swap Submission, or Advance Notice

    The principal purpose of the proposed rule change is to modify
certain provisions of the ICE Clear Europe Articles of Association.

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change, Security-Based Swap Submission or
Advance Notice

    In its filing with the Commission, ICE Clear Europe 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. ICE Clear Europe has prepared
summaries, set forth in sections (A), (B), and (C) below, of the most
significant aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change, Security-Based Swap Submission or
Advance Notice

1. Purpose
    The purpose of the changes is to make certain amendments to ICE
Clear Europe's Articles of Association (the ``Articles''). The
amendments are generally intended to update the Articles to reflect the
Clearing House's committee structure, to modify certain matters
relating to the term of office of directors and to adopt certain new
procedures addressing conflicts of interest of directors, as discussed
in more detail herein.
    In article 1,\3\ a cross-reference to relevant parts of UK
companies regulations has been updated. In article 3, certain
definitions have been updated, including to add definitions for key
existing committees: The Audit Committee, Board Risk Committee,
Compensation Committee and Nominations Committee. The amendments also
update the definition of Risk Committee to refer to product-specific
Risk Committees (as distinct from the Board Risk Committee). A
reference to the former UK Financial Services Authority has been
updated to refer to the Bank of England, consistent with changes in the
UK regulatory structure. A definition has also been added for the
Senior Independent Director, as discussed below. Certain definitional
provisions have also been clarified, including to remove unnecessary
references to certain extraordinary resolutions. Article 4 has been
updated to provide a cross-reference to regulations referred to in
article 1.
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    \3\ References herein to the numbering of particular articles
will be to the articles as amended.
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    Articles 7 and 8 have been revised to remove certain unnecessary
distinctions between annual general meetings of members (i.e.,
shareholders) and extraordinary general meetings of members (given that
the clearing house has a single shareholder). A typographical
correction is made in article 12.
    In article 25, the minimum number of directors has been changed
from two to six (the maximum of twelve is unchanged, as are the
requirements with respect to independent directors). The clearing house
currently has ten directors; as a result, this amendment is not
expected to affect current operations of the board. Article 26 has been
revised to reflect that selection of replacement or additional
directors will be made following recommendation by the Nominations
Committee. Article 29 provides for the board to appoint one of its
independent directors as Senior Independent Director (and to revoke or
termination such appointment at its discretion). The Senior Independent
Director will serve as the lead independent director appointed in
accordance with the UK Corporate Governance Code \4\ as in effect from
time to time (to which the clearing house is subject).
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    \4\ Financial Reporting Council Limited, UK Corporate Governance
Code (April 2016). The code sets out a code of conduct and best
practices for governance matters for UK companies. Among other
matters, the code states that the board should appoint one of the
independent non-executive directors as a senior independent director
``to provide a sounding board for the chairman and to serve as an
intermediary for the other directors when necessary.'' The senior
independent director should lead meetings of the non-executive
directors, at least annually, to evaluate the performance of the
Board chairman.
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    The amendments make certain changes to the procedures for
staggering the retirement or rotation of independent directors. Under
revised Articles 31 and 32, at a general meeting to be held each year,
the two longest serving independent directors (who are not CDS
directors) that have served at least three consecutive years on the
board, at the discretion of the Nominations Committee, must retire from
office, but may offer themselves for reappointment for a new three year
term by the shareholder. An independent director may be so reappointed
a maximum of two times for three year terms, unless the clearing house
by resolution of its sole shareholder determines otherwise. The
provisions for the retirement or rotation of CDS directors are
unchanged. The revised retirement procedures do not apply to directors
other than independent directors. Various conforming and clarifying
changes have been made in article 33, which will provide that a
director whose term ends at a general meeting may be reappointed and if
not, may retain office until the meeting appoints a replacement (or
until the end of the meeting if no replacement is named). In article
34, standards for determining that a director has become incapacitated
have been updated. The amendments also reduce from six to three the
number of consecutive meetings that a director may miss before being
removed on that basis.
    A new article 37 has been added to state explicitly that the
directors will appoint the members of the relevant committees, as is
current practice, consistent with the terms of reference for those
committees, and that the committees will operate in accordance with
such terms of reference. Article 43, which addresses delegation of
board powers to committees, has been revised to refer explicitly to the
Audit Committee, Board Risk Committee, Nominations Committee and
Compensation Committee, and such other committees as the board
determines may be required. A new article 48 has been added to require
independent directors to disclose to the board all other directorships
they hold, both prior to appointment and on an ongoing basis.
    Additional amendments have been made to the provisions of the
Articles relating to conflicts of interest (and potential conflicts of
interest) of directors to ensure that there is a clear procedure in
place to deal with any such conflicts of interest (and potential
conflicts of interest), consistent with the provisions of the UK
Companies Act 2006. In article 52, the prohibition on a director
participating in or voting on a decision in which he or she has an
interest is modified (i) to eliminate a restriction that the interest
be material and (ii) to provide additional exceptions where ICE Clear
Europe by ordinary resolution of the shareholder disapplies the
provision of the Articles that would prevent the director from
participating in that decision or where the director's interest cannot
reasonably be regarded as likely to give rise to a conflict of
interest. A reference to the UK Companies Act 2006 is also corrected,
and an unnecessary reference to that act is removed.
    The amendments also adopt a new article 53, which addresses certain
conflicts of interests and potential conflicts of interest of directors
that do not arise in relation to a transaction or agreement with ICE
Clear Europe (without limiting the obligations of directors under
applicable provisions of the UK Companies Act 2006). In the case of
such a conflict that arises from the appointment or proposed
appointment of a person as a director, the uninterested directors or
the shareholder may nonetheless authorize the appointment of the
director, and address the relevant situation, on such terms as they
determine. In the case of other conflicts, the uninterested directors
or the shareholder may choose to permit the relevant situation and the
continued performance by the interested director of his or her duties,
on such terms as they determine. The interested directors will not be
counted in the

quorum for, and will not be allowed to vote on, any decision of the
directors on such matters. The uninterested directors may act on such
matters even if there are insufficient directors to meet the normal
quorum and voting requirements. The resolution adopted by the
uninterested directors or the shareholder may, for example, permit the
interested directors to vote, exclude the interested directors from all
information and discussion about the relevant situation, and/or impose
additional duties of confidentiality on the interested directors. The
authorization of an interested director situation can be withdrawn or
modified at any time. The article also contains requirements on
directors to provide notice of potential conflicts and specifies
certain other procedures and documentation requirements.
    In article 55, clarifications are made that a director may not
retrospectively waive notice of a meeting more than seven days after
the meeting is held. The revised article also clarifies that the chair
will not have a second or casting vote (in the case of an equally
divided vote) if the chair is not otherwise to be counted for quorum or
voting purposes (such as because of a conflict of interest). In revised
article 60, the requirements for action by written resolution of
directors have been clarified to provide that all directors entitled to
vote on the matter (rather than all directors entitled to receive
notice of a board meeting) must consent to the action.
    The recordkeeping requirements in article 63 have been revised to
provide that the company must keep a written record of all unanimous or
majority decisions of the directors for at least 10 years. Article 69
has been revised to refer to a special rather than extraordinary
resolution.
    Certain other non-substantive corrections and clarifications have
been made in the Articles. For example, various references to persons
throughout the Articles have been revised to be gender-neutral. Various
articles have also been renumbered in light of the changes discussed
above, and related cross-references have been updated.
2. Statutory Basis
    ICE Clear Europe believes that the changes described herein are
consistent with the requirements of Section 17A of the Act \5\ and the
regulations thereunder applicable to it, and in particular are
consistent with the prompt and accurate clearance and settlement of
securities transactions and, to the extent applicable, derivative
agreements, contracts and transactions, the safeguarding of securities
and funds in the custody or control of ICE Clear Europe or for which it
is responsible and the protection of investors and the public interest,
within the meaning of Section 17A(b)(3)(F) of the Act.\6\ As discussed
above, the changes are intended to clarify and update certain aspects
of ICE Clear Europe's Articles, particularly around the committee
structure, retirement and rotation of independent directors and
conflicts of interest of directors. In ICE Clear Europe's view, these
amendments will enhance the clearing house's overall governance
framework, and thus facilitate the efficient operation of the clearing
house and the prompt and accurate clearance and settlement of
transactions and the public interest, within the meaning of the Act.
For these reasons, the amendments will also promote governance
arrangements that are clear and transparent to fulfill the public
interests requirements in Section 17A of the Act applicable to clearing
agencies, support the objectives of owners and participants and promote
the effectiveness of the clearing agency's risk management procedures,
within the meaning of Rule 17Ad-22(d)(8). Furthermore, the amendments
will support governance arrangements that fulfill the requirements of
Rule 17Ad-22(e)(2), including that the directors have appropriate
experience and skills to discharge their duties and responsibilities,
and that the governance arrangements specify clear and direct lines of
responsibility.
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    \5\ 15 U.S.C. 78q-1.
    \6\ 15 U.S.C. 78q-1(b)(3)(F).
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(B) Clearing Agency's Statement on Burden on Competition

    ICE Clear Europe does not believe the proposed changes to the rules
would have any impact, or impose any burden, on competition not
necessary or appropriate in furtherance of the purpose of the Act. The
amendments relate to ICE Clear Europe's internal governance structure
relating to the board of directors and similar matters. ICE Clear
Europe does not believe that these changes will impose any additional
costs on Clearing Members or other market participants. ICE Clear
Europe further does not believe that the amendments will adversely
affect access to clearing by Clearing Members or their customers or
otherwise adversely affect Clearing Members or market participants or
the market for clearing services generally.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants or Others

    Written comments relating to the proposed changes to the rules have
not been solicited or received. ICE Clear Europe will notify the
Commission of any written comments received by ICE Clear Europe.

III. Date of Effectiveness of the Proposed Rule Change, Security-Based
Swap Submission and Advance Notice and Timing for Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.
    The proposal shall not take effect until all regulatory actions
required with respect to the proposal are completed.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml) or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ICEEU-2017-007 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ICEEU-2017-007. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent

amendments, all written statements with respect to the proposed rule
change, security-based swap submission or advance notice that are filed
with the Commission, and all written communications relating to the
proposed rule change, security-based swap submission or advance notice
between the Commission and any person, other than those that may be
withheld from the public in accordance with the provisions of 5 U.S.C.
552, will be available for Web site viewing and printing in the
Commission's Public Reference Room, 100 F Street NE., Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filings will also be available for inspection
and copying at the principal office of ICE Clear Europe and on ICE
Clear Europe's Web site at https://www.theice.com/clear-europe/regulation#rule-filings.
    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-ICEEU-2017-007
and should be submitted on or before June 9, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-10129 Filed 5-18-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: June 3, 2010 (Volume 75, Number 106)]
[Notices]
[Page 31459-31460]
[DOCID:fr03jn10-82]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2009-0136]

Collection of Information Under Review by Office of Management
and Budget: OMB Control Number: 1625-0056

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, this
request for comments announces that the U.S. Coast Guard is forwarding
an Information Collection Request (ICR), abstracted below, to the
Office of Information and Regulatory Affairs (OIRA), Office of
Management and Budget (OMB) requesting an extension of its approval for
the following collection of information: 1625-0056, Labeling required
in 33 CFR parts 181 and 183 and 46 CFR 25.10-3. Our ICR describes the
information we seek to collect from the public. Review and comments by
OIRA ensure we only impose paperwork burdens commensurate with our
performance of duties.

DATES: Please submit comments on or before July 6, 2010.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2009-0136] to the Docket Management Facility (DMF) at the
U.S. Department of Transportation (DOT) or to OIRA. To avoid
duplication, please submit your comments by only one of the following
means:
    (1) Electronic submission. (a) To Coast Guard docket at http://
www.regulation.gov. (b) To OIRA by e-mail via: oira_
<EMAIL_ADDRESS>    (2) Mail or Hand delivery. (a) DMF (M-30), DOT, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC
20590-0001. Hand deliver between the hours of 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays. The telephone number is 202-
366-9329. (b) To OIRA, 725 17th Street, NW., Washington, DC 20503,
attention Desk Officer for the Coast Guard.
    (3) Fax. (a) To DMF,<PHONE_NUMBER>. (b) To OIRA at<PHONE_NUMBER>. To
ensure your comments are received in a timely manner, mark the fax,
attention Desk Officer for the Coast Guard.
    The DMF maintains the public docket for this Notice. Comments and
material received from the public, as well as documents mentioned in
this Notice as

being available in the docket, will become part of the docket and will
be available for inspection or copying at room W12-140 on the West
Building Ground Floor, 1200 New Jersey Avenue, SE., Washington, DC,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. You may also find the docket on the Internet at http://
www.regulations.gov.
    A copy of the ICR is available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
Commandant (CG-611), Attn Paperwork Reduction Act Manager, U.S. Coast
Guard, 2100 2nd St., SW., Stop 7101, Washington DC 20593-7101.

FOR FURTHER INFORMATION CONTACT: Contact Mr. Arthur Requina, Office of
Information Management, telephone<PHONE_NUMBER> or fax<PHONE_NUMBER>, for
questions on these documents. Contact Ms. Renee V. Wright, Program
Manager, Docket Operations,<PHONE_NUMBER>, for questions on the docket.

SUPPLEMENTARY INFORMATION: The Coast Guard invites comments on whether
this ICR should be granted based on it being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
collections; (2) the accuracy of the estimated burden of the
collections; (3) ways to enhance the quality, utility, and clarity of
information subject to the collections; and (4) ways to minimize the
burden of collections on respondents, including the use of automated
collection techniques or other forms of information technology.
    Comments to Coast Guard or OIRA must contain the OMB Control Number
of the ICR. They must also contain the docket number of this request,
[USCG 2009-0136]. For your comments to OIRA to be considered, it is
best if they are received on or before the July 6, 2010.
    Public participation and request for comments: We encourage you to
respond to this request by submitting comments and related materials.
We will post all comments received, without change, to http://
www.regulations.gov. They will include any personal information you
provide. We have an agreement with DOT to use their DMF. Please see the
``Privacy Act'' paragraph below.
    Submitting comments: If you submit a comment, please include the
docket number [USCG-2009-0136], indicate the specific section of the
document to which each comment applies, providing a reason for each
comment. We recommend you include your name, mailing address, an e-mail
address, or other contact information in the body of your document so
that we can contact you if we have questions regarding your submission.
You may submit comments and material by electronic means, mail, fax, or
delivery to the DMF at the address under ADDRESSES; but please submit
them by only one means. If you submit them by mail or delivery, submit
them in an unbound format, no larger than 8\1/2\ by 11 inches, suitable
for copying and electronic filing. If you submit them by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. In response to your comments, we
may revise the ICR or decide not to seek an extension of approval for
this collection. The Coast Guard and OIRA will consider all comments
and material received during the comment period.
    Viewing comments and documents: Go to http://www.regulations.gov to
view documents mentioned in this Notice as being available in the
docket. Click on the ``read comments'' box, which will then become
highlighted in blue. In the ``Keyword'' box insert ``USCG-2009-0136''
and click ``Search.'' Click the ``Open Docket Folder'' in the
``Actions'' column. You may also visit the DMF in room W12-140 on the
West Building Ground Floor, 1200 New Jersey Avenue, SE., Washington,
DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.
    Privacy Act: Anyone can search the electronic form of all comments
received in dockets by the name of the individual submitting the
comment (or signing the comment, if submitted on behalf of an
association, business, labor union, etc.). You may review the Privacy
Act statement regarding our public dockets in the January 17, 2008
issue of the Federal Register (73 FR 3316).

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard published the 60-day notice (75 FR 1068, January 8, 2010)
required by 44 U.S.C. 3506(c)(2). That Notice elicited no comments.

Information Collection Request

    Title: Labeling required in 33 CFR Parts 181 and 183 and 46 CFR
25.10-3.
    OMB Control Number: 1625-0056.
    Type of Request: Extension of a currently approved collection.
    Respondents: Manufacturers of boats, fuel tanks/hoses and
navigation lights.
    Abstract: Title 46 U.S.C. 4302(a)(3) gives the Coast Guard
authority to require the display of seals, labels, plates, insignia, or
other devices for certifying/evidencing compliance with safety
regulations and standards of the United States Government for
recreational vessels and associated equipment.
    Forms: None.
    Burden Estimate: The estimated burden has decreased from 395,107 to
299,141 hours a year.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: May 25, 2010.
M.B. Lytle,
Captain, U.S. Coast Guard, Acting Assistant Commandant for Command,
Control, Communications, Computers and Information Technology.
[FR Doc. 2010-13382 Filed 6-2-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 84 (Thursday, April 30, 2020)]
[Notices]
[Pages 23968-23969]
[FR Doc No: 2020-09163]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-2834]

Extension of Certain Tobacco Product Compliance Deadlines Related
to the Final Deeming Rule; Withdrawal of Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the withdrawal of a guidance for industry entitled ``Extension of
Certain Tobacco Product Compliance Deadlines Related to the Final
Deeming Rule,'' which was issued in 2017. The guidance was intended to
assist persons who manufacture, package, sell, offer to sell,
distribute, or import for sale and distribution within the United
States newly regulated tobacco products, roll-your-own (RYO) tobacco,
and cigarette tobacco in complying with the Federal Food, Drug, and
Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention
and Tobacco Control Act (Tobacco Control Act), and FDA regulations. FDA
is withdrawing the guidance because the compliance deadlines contained
therein have passed, have been vacated or stayed, or are otherwise
described in other guidance.

DATES: The withdrawal is applicable April 30, 2020.

FOR FURTHER INFORMATION CONTACT: Eric C. Mandle, Center for Tobacco
Products, Food and Drug Administration, 10903 New Hampshire Ave.,
Document Control Center, Bldg. 71, Rm. G335, Silver Spring, MD 20993-
0002; 1-877-287-1373<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is withdrawing the guidance for industry
entitled ``Extension of Certain Tobacco Product Compliance Deadlines
Related to the Final Deeming Rule,'' which was issued in 2017 (see 82
FR 37459 (August 10, 2017)) and which has been revised several times
since then. The guidance was intended to assist persons who
manufacture, package, sell, offer to sell, distribute, or import for
sale and distribution within the United States newly regulated tobacco
products, RYO tobacco, and cigarette tobacco in complying with the FD&C
Act, as amended by the Tobacco Control Act, and FDA regulations.
    The Tobacco Control Act (Pub. L. 111-31) granted FDA the authority
to immediately regulate the manufacture, marketing, and distribution of
cigarettes, cigarette tobacco, RYO, and smokeless tobacco products to
protect the public health and to reduce tobacco use by minors.
    The Tobacco Control Act also gave FDA the authority to issue a
regulation deeming all other products that meet the statutory
definition of a tobacco product to be subject to chapter IX of the FD&C
Act (section 901(b) (21 U.S.C. 387a(b)) of the FD&C Act). On May 10,
2016, FDA issued that rule, extending FDA's tobacco product authority
to all products that meet the definition of tobacco product in the law
(except for accessories of newly regulated tobacco products), including
electronic nicotine delivery systems, cigars, hookah, pipe tobacco,
nicotine gels, dissolvables that were not already subject to the FD&C
Act, and other tobacco products that may be developed in the future (81
FR 28974 at 28976) (``the final deeming rule'').
    In May 2017, FDA published the first edition of this guidance,
under which it provided a 3-month extension of all future compliance
deadlines under the final deeming rule. The second edition of the
guidance, published in August 2017, revised and updated the first
edition by further extending certain of the future compliance dates.
    On May 15, 2019, the U.S. District Court for the District of
Maryland issued an order vacating the extended compliance dates for
premarket review in the guidance.\1\ On July 12, 2019, the court issued
an order directing FDA to require that premarket authorization
applications for all new--i.e., not ``grandfathered'' \2\--deemed
tobacco products to be submitted to the Agency within 10 months, by May
12, 2020, and providing for a 1-year period during which products with
timely filed applications might remain on the market pending FDA
review.\3\ As

required by the court's order, deemed new tobacco products on the
market as of August 8, 2016, for which premarket authorization
applications are not filed by May 12, 2020, are subject to FDA
enforcement actions, in the Agency's discretion. The court subsequently
clarified that its order did not restrict FDA's authority to enforce
the premarket review provisions against deemed products, prior to May
12, 2020, or during the 1-year review period.\4\ On April 22, 2020, the
court, upon FDA's motion, extended the premarket application deadline
set out in its order by 120 days (until September 9, 2020) in light of
the global outbreak of respiratory illness caused by a new
coronavirus.\5\
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    \1\ American Academy of Pediatrics, et al. v. Food and Drug
Administration, et al., 379 F.Supp.3d 461 (D. Md. 2019).
    \2\ A ``grandfathered'' product is one that was on the market as
of February 15, 2007. ``Guidance for Industry, Establishing That a
Tobacco Product Was Commercially Marketed in the United States as of
February 15, 2007,'' dated September 2014, available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishing-tobacco-product-was-commercially-marketed-united-states-february-15-2007.
    \3\ American Academy of Pediatrics, et al. v. Food and Drug
Administration, et al., 399 F.Supp.3d 479 (D. Md. 2019). The court
has granted intervention to vapor industry trade associations for
purposes of appealing the court's decision and remedies order. See
American Academy of Pediatrics, et al. v. Food and Drug
Administration, et al., No. 8:18-cv-883 (PWG), Dkt. No. 154 (October
2, 2019). An appeal is pending. See American Academy of Pediatrics
v. Cigar Ass'n of America, Nos. 19-2130, -2132, -2198 (4th Cir.).
    \4\ American Academy of Pediatrics, et al. v. Food and Drug
Administration, et al., Case No. 8:18-cv-883 (PWG), (D. Md. August
12, 2019), Dkt. No. 132.
    \5\ American Academy of Pediatrics, et al. v. Food and Drug
Administration, et al., Case No. 8:18-cv-883 (PWG), (D. Md. April
22, 2020), Dkt. No. 182.
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    FDA is withdrawing the guidance because the compliance deadlines
contained therein have passed, have been vacated, or are stayed, with
the exception of those for reporting requirements for harmful or
potentially harmful constituents (HPHC). FDA has published and
described these deadlines in the Small Entity Compliance Guide for the
final deeming rule; \6\ they are also listed on the Center for Tobacco
Products' HPHC website.\7\
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    \6\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-deems-certain-tobacco-products-subject-fda-authority-sales-and-distribution-restrictions-and.
    \7\ For more information, please see https://www.fda.gov/tobacco-products/products-ingredients-components/harmful-and-potentially-harmful-constituents-hphcs.

    Dated: April 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-09163 Filed 4-29-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 24 (Wednesday, February 5, 2014)]
[Notices]
[Pages 6897-6899]
[FR Doc No: 2014-02224]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2013-0742; FRL-9903-50]

Agency Information Collection Activities; Proposed Collection;
Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this
document announces that EPA is planning to submit an Information
Collection Request (ICR) to the Office of Management and Budget (OMB).
The ICR, entitled: ``Submission of Unreasonable Adverse Effects
Information Under FIFRA Section 6(a)(2)'' and identified by EPA ICR No.
1204.12 and OMB Control No. 2070-

0039, represents the renewal of an existing ICR that is scheduled to
expire on September 30, 2014. Before submitting the ICR to OMB for
review and approval, EPA is soliciting comments on specific aspects of
the proposed information collection that is summarized in this
document. The ICR and accompanying material are available in the docket
for public review and comment.

DATES: Comments must be received on or before April 7, 2014.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2013-0742, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Scott Drewes, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What information is EPA particularly interested in?

    Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)),
EPA specifically solicits comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What information collection activity or ICR does this action apply
to?

    Title: Submission of Unreasonable Adverse Effects Information Under
FIFRA Section 6(a)(2).
    ICR number: EPA ICR No. 1204.12.
    OMB control number: OMB Control No. 2070-0039.
    ICR status: This ICR is currently scheduled to expire on September
30, 2014. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the Code of Federal Regulations (CFR), after
appearing in the Federal Register when approved, are listed in 40 CFR
part 9, are displayed either by publication in the Federal Register or
by other appropriate means, such as on the related collection
instrument or form, if applicable. The display of OMB control numbers
for certain EPA regulations is consolidated in 40 CFR part 9.
    Abstract: Section 6(a)(2) of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) requires pesticide registrants to submit
information to the Agency which may be relevant to the balancing of the
risks and benefits of a pesticide product. The statute requires the
registrant to submit any factual information that it acquires regarding
adverse effects associated with its pesticidal products, and it is up
to the Agency to determine whether or not that factual information
constitutes an unreasonable adverse effect. In order to limit the
amount of less meaningful information that might be submitted to the
Agency, EPA has limited the scope of factual information that the
registrant must submit. The Agency's regulations at 40 CFR part 159
provide a detailed description of the reporting obligations of
registrants under FIFRA section 6(a)(2).
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 2.85
hours per response. Burden is defined in 5 CFR 1320.3(b).
    The ICR, which is available in the docket along with other related
materials, provides a detailed explanation of the collection activities
and the burden estimate that is only briefly summarized here:
    Respondents/affected entities: Entities potentially affected by
this ICR include anyone who holds or has ever held a registration for a
pesticide product issued under FIFRA section 3 or 24(c). The North
American Industrial Classification System (NAICS) code is 325300
(pesticide, fertilizer and other agricultural chemical manufacturing).
    Estimated total number of potential respondents: 1,738.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent:
54.
    Estimated total annual burden hours: 264,957 hours.
    Estimated total annual costs: $15,940,734. There is no capital
investment or maintenance and operational costs associated with this
ICR.

III. Are there changes in the estimates from the last approval?

    There is an increase of 61,721 hours in the total estimated
respondent burden compared with that identified in the ICR currently
approved by OMB. This increase reflects EPA's updating of burden
estimates for this collection based upon historical information on the
number incident reports per submission. Based upon revised estimates,
the number of incident reports has increased from 71,000 to 93,000 with
a corresponding increase in the associated burden. This change is an
adjustment.

IV. What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to
announce the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the person listed under FOR
FURTHER INFORMATION CONTACT.

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: January 14, 2014.
James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2014-02224 Filed 2-4-14; 8:45 am]
BILLING CODE 6560-50-P


14329 Northdale Boulevard, Rogers, MN 55374 Voice: 763.428.5075 Fax: 763.428.5078 e mail: jeffstriggow@ endisys. com www. endisys. com An Engineered Distribution Specialties, LLC Company Wednesday, February 04, 2004 1200 Pennsylvania NW Mail Code 6205J Washington, DC 20460 Suzanne Kocchi U. S. Environmental Protection Agency 1310 L Street, NW Washington, DC 20005 Dear Ms Kocchi,

Engineered Distribution Specialties LLC ( EnDiSys) is a specialty equipment manufacturer that is actively working with the urethane spray industry to offer next generation rigid spray foam equipment. We would like to make the EPA aware of our commercial introduction of a complete product line of equipment designed for rigid spray foam systems using HCFC 141b blowing agent alternatives. The Poly XP can be used with either Exxsol   Blowing Agent or Enovate

3000 based systems to meet this emerging industry requirement.

We began commercially selling these machines in September 2003 and general interest during customer demonstrations has been relatively high. Our commercial efforts to offer these new units however has been hampered by the continued availability of HCFC 141b systems in the market place and the reluctance of many in the spray foam community to accept change. We feel the EPA should move forward to ban the use of HCFC 141b now that cost competitive non ozone depleting alternative formulations and equipment are clearly commercially available.

EnDiSys has developed classified spray equipment that meets a range of industry requirements. Our Poly XP proportioners can be configured to deliver foam at 26 or 50 lbs/ min with either air or hydraulic systems. In addition, EnDiSys currently manufactures trailers for spray applications and have the capability to produce trailers configured for a range of blowing agent options. Our current HCFC 141b trailer designs and options can be modified to meet the unique requirements of the new alternatives.

Our equipment has been used with contractor groups in a series of demonstrations and training programs around the country working with NCFI and others. We will be giving contractors the opportunity to evaluate our equipment once again at the Spray Foam 2004 show in Reno, NV on February 10. EnDiSys is eager to work with interested spray foam industry groups and individuals to make this equipment widely available. We plan to continue to offer the spray foam sector next generation equipment however we require assistance from the U. S. EPA to support this industry transition.

Please contact us if you wish to discuss the transition issues or have additional questions regarding the EnDiSys Poly XP product line.

Sincerely,

Jeffrey Striggow President


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, D.C.

Issued by the Department of Transportation on June 9, 2005

NOTICE OF ACTION TAKEN -- DOCKET OST-2004-17492

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  COMPANIA MEXICANA de AVIACION, S.A. de C.V. (Mexicana)		Date
Filed:  April 5, 2004

Relief requested:  Renewal of exemption from 49 USC § 41301 to permit
the applicant to continue to conduct scheduled foreign air
transportation of persons, property, and mail between the Mexican
coterminal points Guadalajara/Morelia/Mexico City/Zacatecas/ Leon-El
Bajio, and Fresno, California.

If renewal, date and citation of last action:  April 22, 2004.

Applicant representative:  Charles F. Donley II,<PHONE_NUMBER>		DOT
analyst:  Brian J. Hedberg,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved.
                                           		Action date:  June 9, 2005

Effective dates of authority granted:  June 9, 2005, through June 9,
2006.

Basis for approval (bilateral agreement/reciprocity):  United
States-Mexico Air Transport Services Agreement.

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations set forth in our standard exemption
conditions (attached), and to the otherwise-applicable terms, conditions
and limitations of Mexicana’s foreign air carrier permit (Order
78-6-127).

Special conditions/Remarks:

Action taken by:  Paul L. Gretch, Director

			 Office of International Aviation

________________________________________________________________________
______________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) the applicant was qualified to perform its proposed
operations; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

FOREIGN CARRIER EXEMPTION CONDITIONS
                              ATTACHMENT

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

1) Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

2) Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Trans- portation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

3) Comply with the requirements for minimum insurance coverage contained
in 14 CFR Part 205, and, prior to the commencement of any operations
under this authority, file evidence of such coverage, in the form of a
completed OST Form 6411, with the Federal Aviation Administration’s
Program Management Branch (AFS-260), Flight Standards Service (any
changes to, or termination of, insurance also shall be filed with that
office);

4) Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

5) Conform to the airworthiness and airman competency requirements of
its Government for international air services;

6) Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

7) Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: a) based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or b) based on
a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term “international air transportation” means “international
transportation” as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

8) Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

9) Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department’s
rules governing charters (including 14 CFR Parts 212 and 380); and

11) Comply with such other reasonable terms, conditions, and limitations
required by the public interest as may be prescribed by the Department,
with all applicable orders or regulations of other U.S. agencies and
courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

 05/2004