[Federal Register: February 20, 2008 (Volume 73, Number 34)]
[Notices]
[Page 9369-9370]
[DOCID:fr20fe08-120]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 27d-2; SEC File No. 270-500; OMB Control No. 3235-0566.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collections of information under the Investment Company Act of 1940 (15
U.S.C. 80a) (``Act'') summarized below. The Commission plans to submit
these collections of information to the Office of Management and Budget
for approval.
    Rule 27d-2 (17 CFR 270.27d-2) is entitled ``Insurance Company
Undertaking in Lieu of Segregated Trust Account.'' Rule 27d-1 (17 CFR
270.27d-1) \1\ under the Act requires the depositor or principal
underwriter for an issuer of periodic payment plans to deposit funds
into a segregated trust account to provide assurance of its ability to
fulfill its refund obligations under sections 27(d) and 27(f).\2\ Rule
27d-2 provides an exemption from rule 27d-1 under the Act for
depositors or principal underwriters for the issuers of periodic
payments plans. In order to comply with the rule: (i) The depositor or
principal underwriter must secure from an insurance company a written
guarantee of the refund requirements; (ii) the insurance company must
satisfy certain financial criteria; and (iii) the depositor or
principal underwriter must file as an exhibit to the issuer's
registration statement, a copy of the written undertaking, an annual
statement that the insurance company has met the requisite financial
criteria on a monthly basis, and an annual audited balance sheet.
---------------------------------------------------------------------------

    \1\ The information collection requirements for rule 27d-1 and
Form N-27D-1 are covered in a separate Federal Register notice under
OMB Control No. 3235-0560.
    \2\ The rule sets forth minimum reserve amounts and guidelines
for the management and disbursement of the assets in the account.
Rule 27d-1(j) directs depositors and principal underwriters annually
to make an accounting of their segregated trust accounts on Form N-
27D-1, which is filed with the Commission. The form requires
depositors and principal underwriters to report deposits to a
segregated trust account, including those made pursuant to
paragraphs (c) and (e) of the rule. Withdrawals pursuant to
paragraph (f) of the rule also must be reported. In addition, the
form solicits information regarding the minimum amount required to
be maintained under paragraphs (d) and (e) of rule 27d-1.
---------------------------------------------------------------------------

    Rules 27d-1 and 27d-2, which were explicitly authorized by statute,
provide assurance that depositors and principal underwriters of issuers
have access to sufficient cash to meet the demands of certificate
holders who reconsider their decisions to invest in a periodic payment
plan. The information collection requirements in rules 27d-1 and 27d-2
enable the Commission to monitor compliance with reserve rules.
    Only one registered investment company has issued a new periodic
payment plan certificate within the past 18 months, and the principal
underwriter or depositor for this sole issuer relies on the exemption
in rule 27d-2. The respondent makes approximately three responses per
year.\3\ The insurance company provides the written undertaking, annual
statement, and certified balance sheet at no cost to the respondent.
The staff estimates that the respondent spends approximately one hour
per year filing the required documents from the insurance company on
EDGAR. Thus, we estimate that the annual burden is approximately 1
hour.
---------------------------------------------------------------------------

    \3\ The three responses are: (i) obtaining and filing the
written undertaking or an amendment to the undertaking, (ii) filing
the insurance company's annual statement that the financial
conditions were satisfied, and (iii) filing the insurance company's
certified balance sheet.
---------------------------------------------------------------------------

    The staff believes that rule 27d-2 does not impose any cost burdens
other than those arising from the hour burdens discussed above.
    The estimates of average burden hours and costs are made solely for
the purposes of the Paperwork Reduction Act, and are not derived from a
comprehensive or even a representative survey or study of the costs of
Commission rules and forms.\4\
---------------------------------------------------------------------------

    \4\ These estimates are based on telephone interviews between
the Commission staff and representatives of depositors or principal
underwriters of periodic payment plan issuers.
---------------------------------------------------------------------------

    Complying with the collection of information requirements of rule
27d-2 is mandatory for depositors or principal underwriters of issuers
of periodic payment plans who rely on the rule for an exemption from
complying with rule 27d-1 and filing Form N-27D-1 (17 CFR 274.127d-1).
The information provided pursuant to rule 27d-2 is public and,
therefore, will not be kept confidential.
    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.

    Written comments are invited on: (a) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information has practical
utility; (b) the accuracy of the Commission's estimate of the burden of
the collection of information; (c) ways to enhance the quality,
utility, and clarity of the information collected; and (d) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Consideration will be given to
comments and suggestions submitted in writing within 60 days of this
publication.
    Please direct your written comments to R. Corey Booth, Director/
Chief Information Officer, Securities and Exchange Commission, C/O
Shirley Martinson, 6432 General Green Way, Alexandria, VA 22312; or
send an e-mail to<EMAIL_ADDRESS>
    Dated: February 14, 2008.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E8-3109 Filed 2-19-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: May 6, 2010 (Volume 75, Number 87)]
[Rules and Regulations]
[Page 24799]
[DOCID:fr06my10-7]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2010-0102]
RIN 1625-AA08

Special Local Regulation for Marine Events; Temporary Change of
Dates for Recurring Marine Events in the Fifth Coast Guard District;
Correction

ACTION: Temporary final rule; correction.

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

SUMMARY: In the Federal Register published on April 19, 2010, the Coast
Guard temporarily changed the enforcement period of two special local
regulations for recurring marine events in the Fifth Coast Guard
District, one on April 17-18, 2010, and one on May 29-30, 2010. That
publication contained several errors. These errors do not impact the
events scheduled for this year, but could cause confusion about future
years.

DATES: This correction is effective May 6, 2010.

FOR FURTHER INFORMATION CONTACT: For information about this correction,
contact Kevin d'Eustachio, Office of Regulations and Administrative
Law, telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>For
information about the original regulation, contact LT Tiffany Duffy,
Project Manager, Sector Hampton Roads, Waterways Management Division,
United States Coast Guard; telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:  In FR doc 2010-8861 appearing on page 20294
in the issue of Monday, April 19, 2010, the following corrections are
made:
    1. In the summary on page 20294, in the first column, remove the
words ``proposes to temporarily change'' and add in their place the
words ``temporarily changes''.
    2. On page 20294, in the third column, revise the ``DATES'' section
to read as follows:

    ``DATES: This rule is effective in the CFR April 19, 2010,
through May 31, 2010. This rule is effective with actual notice for
purposes of enforcement from April 7, 2010, through May 31, 2010.''

    3. On page 20296, in the third column, revise amendatory
instruction number 2 to read as follows:
    ``2. In Sec. 100.501, suspend line No. 31 and 38 in the Table to
Sec. 100.501 from April 17, 2010 through June 1, 2010.''

    4. On page 20296, in the third column revise amendatory instruction
number 3 to read as follows:

    ``3. In Sec. 100.501 add lines No. 58 and 59 in Table to Sec.
100.501 to read as follows:''

    Dated: April 28, 2010.
S. Venckus,
Office of Regulations and Administrative Law (CG-0943), U.S. Coast
Guard.
[FR Doc. 2010-10602 Filed 5-5-10; 8:45 am]
BILLING CODE 9110-04-P


                                 Placeholder
   This .zip file has been sent to the Docket Office for upload to OneDrive
                  IPM Post-IRA 2022 Reference RPE (zip file)
Abstract:  EPA Integrated Planning Model (IPM) Post-IRA 2022 Reference RPE  (zip file containing .xlsx file available separately)


[Federal Register Volume 87, Number 218 (Monday, November 14, 2022)]
[Notices]
[Pages 68208-68210]
[FR Doc No: 2022-24648]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96247; File No. SR-NYSE-2022-48]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Delete Legacy Disciplinary Rules 475, 476, 476A, and 477; Adopt New
Rule 2050; and Make Conforming Changes to Rules 2A, 27, 36, 600A, 619,
637, 3170, 8001, 8130, 8320, 9001 and 9217

November 7, 2022.
    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 October 27, 2022, New York Stock Exchange LLC (``NYSE'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the 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 (1) delete legacy disciplinary Rules 475,
476, 476A, and 477 as obsolete and make conforming changes to Rules 2A,
36, 600A(c), 637, 8001, 8130(d), 8320(d) and 9001, and (2) adopt a new
Rule 2050 incorporating the substantive violations currently in Rule
476(a) without change and make conforming changes to Rules 27, 619(h),
3170(C)(3) and 9217. The proposed rule change is available on the
Exchange's website at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to (1) delete legacy disciplinary Rules 475,
476, 476A, and 477 as obsolete and make conforming changes to Rules 2A,
36, 600A(c), 637, 8001, 8130(d), 8320(d) and 9001, and (2) adopt a new
Rule 2050 incorporating the substantive violations currently in Rule
476(a) without change and make conforming changes to Rules 27, 619(h),
3170(C)(3) and 9217.
Background and Proposed Rule Change
    In 2013, the Commission approved the Exchange's adoption of rules
relating to investigation, discipline, and sanctions, and other
procedural rules, based on the rules of the Financial Industry
Regulatory Authority (``FINRA'').\3\ The Exchange represented in that
filing that when the transition to the new disciplinary rules was
complete and there are no longer any member organizations or persons
subject to Rules 475, 476, 476A, and 477, the Exchange would submit a
proposed rule change that would delete such rules (except for the
listed offenses under NYSE Rule 476(a)).\4\ The Exchange represents
that the transition to the new disciplinary rules is complete and there
are no longer any member organizations or persons \5\ subject to Rules
475, 476,

476A, and 477, and that those rules can therefore be deleted as
obsolete.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 69045 (March 5,
2013), 78 FR 15394 (March 11, 2013) (SR-NYSE-2013-02) (Order
Approving Proposed Rule Change Adopting Investigation, Disciplinary,
Sanction, and Other Procedural Rules That Are Modeled on the Rules
of the Financial Industry Regulatory Authority and To Make Certain
Conforming and Technical Changes). Beginning in 2016, the Exchange's
affiliates have each in turn adopted the FINRA disciplinary rules.
In 2016, NYSE American LLC (``NYSE American'') adopted its Rule 8000
and Rule 9000 Series based on the NYSE and FINRA Rule 8000 and Rule
9000 Series. See Securities Exchange Act Release Nos. 77241
(February 26, 2016), 81 FR 11311 (March 3, 2016) (SR-NYSEMKT-2016-
30). In 2018, the Commission approved NYSE National, Inc.'s (``NYSE
National'') adoption of the NYSE National Rule 10.8000 and Rule
10.9000 Series based on the NYSE American and FINRA Rule 8000 and
Rule 9000 Series. See Securities Exchange Act Release No. 83289 (May
17, 2018), 83 FR 23968 (May 23, 2018) (SR-NYSENat-2018-02). In 2019,
NYSE Arca, Inc. (``NYSE Arca'') adopted the NYSE Arca Rule 10.8000
and 10.9000 Series based on the NYSE American Rule 8000 and Rule
9000 Series. See Securities Exchange Act Release No. 85639 (April
12, 2019), 84 FR 16346 (April 18, 2019) (SR-NYSEArca-2019-15). Most
recently, NYSE Chicago also adopted investigation, disciplinary,
sanction, and other procedural rules modeled on the rules of its
affiliates. See Securities Exchange Act Release No. 95020 (June 1,
2022), 87 FR 35034 (June 8, 2022) (SR-NYSECHX-2022-10).
    \4\ See Securities Exchange Act Release No. 68678 (January 16,
2013), 78 FR 5213, 5219 (January 24, 2013) (SR-NYSE-2013-02) (Notice
of Filing of Proposed Rule Change Adopting Investigation,
Disciplinary, Sanction, and Other Procedural Rules That Are Modeled
on the Rules of the Financial Industry Regulatory Authority and To
Make Certain Conforming and Technical Changes) (``Release No.
68678'').
    \5\ The Exchange no longer has allied members. The references to
``allied member'' in Rules 476 and 476A should be to ``principal
executive.'' In 2008, the Exchange replaced the term ``allied
member'' with the newly defined category of ``principal executive''
but did not make corresponding technical changes to Rules 476 and
476A. See Securities Exchange Act Release No. 58549 (September 15,
2008), 73 FR 54444, 54445 (September 19, 2008) (SR-NYSE-2008-80)
(Notice of Filing and Immediate Effectiveness of Proposed Rule
Change and Amendment No. 1 Thereto Conforming Certain NYSE Rules to
Changes to NYSE Incorporated Rules Recently Filed by the Financial
Industry Regulatory Authority, Inc.); Rule 311.18 (defining
``principal executive''). See generally Securities and Exchange Act
Release No. 58103 (July 3, 2008), 73 FR 40403, 40403-04 (July 14,
2008) (SR-FINRA-2008-036) (Notice of Filing of a Proposed Rule
Change Relating to the Incorporated NYSE Rules) (proposing in part
to substitute ``principal executive'' for ``allied member'' in the
Incorporated NYSE Rules); Securities and Exchange Act Release No.
58533 (September 12, 2008), 73 FR 54652 (September 22, 2008) (SR-
FINRA-2008-036) (Order Approving Proposed Rule Change Relating to
Incorporated NYSE Rules). The Exchange will be submitting a separate
rule filing to replace the remaining references to ``allied member''
in its rules with ``principal executive.''
---------------------------------------------------------------------------

    The Exchange proposes conforming changes to Rules 2A
(Jurisdiction), 36 (Communications Between Exchange and Members'
Offices), 600A(c), and 637 (Failure to Honor Award) that contain
references to one or more of the rules proposed to be deleted. The
following rules reflecting the transition from the legacy disciplinary
rules to the current rule set would be deleted in their entirety: Rule
8130(d) (Retention of Jurisdiction); Rule 8320(d) (Payment of Fines,
Other Monetary Sanctions, or Costs; Summary Action for Failure to Pay);
Rule 8001 (Effective Date of Rule 8000 Series); and Rule 9001
(Effective Date of Rule 9000 Series).
    In connection with the deletion of Rule 476, the Exchange also
proposes a new Rule 2050 titled ``Other Offenses'' that would,
consistent with its filing adopting the FINRA disciplinary rules,
retain the listed offenses in Rule 476(a)(1)-(11) without substantive
change. Proposed Rule 2050 would provide that a member organization or
covered person \6\ violates the provisions of the Rule if it commits
any of the enumerated offenses, which would be transposed from Rule
476(a) in the same order and without changes except for Rule 476(a)(8),
which is marked ``Reserved.'' The Exchange further proposes conforming
changes to the following rules to replace references to Rule 476(a)
with Rule 2050: Rule 27 (Regulatory Cooperation); Rule 619(h) (General
Provision Governing Subpoenas, Production of Documents, etc.); Rule
3170(C)(3) (Tape Recording of Registered Persons by Certain Firms); and
Rule 9217 (Violations Appropriate for Disposition Under Rule 9216(b)).
---------------------------------------------------------------------------

    \6\ NYSE Rule 9120(g) defines ``covered person'' to mean a
``member, principal executive, approved person, registered or non-
registered employee of a member organization, or other person
(excluding a member organization) subject to the jurisdiction of the
Exchange.'' The term was drafted to appropriately capture all
persons subject to the legacy disciplinary rules and preserve the
Exchange's scope of jurisdiction at the time the Rule 8000 and Rule
9000 Series were adopted. See Release No. 68678, 78 FR 5213 at 5219.
Under NYSE Rule 2(a), the term ``member'' means a natural person
associated with a member organization who has been approved by the
Exchange and designated by such member organization to effect
transactions on the floor of the Exchange or any facility thereof.
See id.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b)(5) of the Exchange Act,\7\ in that it is designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to foster cooperation and
coordination with persons engaged in facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system and, in general, to
protect investors and the public interest.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Specifically, the Exchange believes that deletion of the obsolete
legacy disciplinary rules now that there are no longer any member
organizations or persons subject to those rules, and making conforming
changes to the rules referencing those legacy disciplinary rules, would
increase the clarity and transparency of the Exchange's rules and
remove impediments to and perfect the mechanism of a free and open
market by ensuring that persons subject to the Exchange's jurisdiction,
regulators, and the investing public could more easily navigate and
understand the Exchange Bylaws and rules. The Exchange further believes
that the proposed amendments would not be inconsistent with the public
interest and the protection of investors because investors will not be
harmed and in fact would benefit from increased transparency and
clarity, thereby reducing potential confusion.
    The Exchange further believes that retaining the substantive
offenses in Rule 476(a) without change is designed to prevent
fraudulent and manipulative acts and practices by permitting the
Exchange to continue to carry out its oversight and enforcement
responsibilities with respect to the substantive provisions currently
enumerated in Rule 476(a). For the same reasons, retention of those
provisions would not be inconsistent with the public interest and the
protection of investors.

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 that is not necessary or appropriate
in furtherance of the purposes of the Exchange Act. The proposed rule
change is not intended to address competitive issues but rather is
concerned solely with deleting obsolete rules and making related and
conforming changes.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the proposed rule change does not: (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) 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 \8\ and subparagraph (f)(6) of Rule 19b-4
thereunder.\9\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6). In addition, Rule19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its 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 this requirement.
---------------------------------------------------------------------------

    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. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. 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 protected]. Please include
File Number SR-NYSE-2022-48.

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-NYSE-2022-48. 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 website (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 website 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
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. Persons submitting comments are cautioned that we do
not redact or edit personal identifying information from comment
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NYSE-2022-48, and should be submitted on or before December 5, 2022.

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

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

J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-24648 Filed 11-10-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Notices]
[Pages 63869-63871]
[FR Doc No: 2015-26699]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-1999-5578; FMCSA-1999-5748; FMCSA-2002-12844; FMCSA-
2003-15268; FMCSA-2003-15892; FMCSA-2004-17984; FMCSA-2005-20560;
FMCSA-2005-21711; FMCSA-2006-26653; FMCSA-2007-27515; FMCSA-2007-27897;
FMCSA-2007-29019; FMCSA-2009-0121; FMCSA-2009-0154; FMCSA-2009-0206;
FMCSA-2011-0057; FMCSA-2011-0124; FMCSA-2011-0189; FMCSA-2013-0028;
FMCSA-2013-0029; FMCSA-2013-0030; FMCSA-2013-0165; FMCSA-2013-0166]

Qualification of Drivers; Exemption Applications; Vision

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

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

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

SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
64 individuals. FMCSA has statutory authority to exempt individuals
from the vision requirement if the exemptions granted will not
compromise safety. The Agency has concluded that granting these
exemption renewals will provide a level of safety that is equivalent to
or greater than the level of safety maintained without the exemptions
for these commercial motor vehicle (CMV) drivers.

DATES: Each group of renewed exemptions are effective from the dates
stated in the discussions below. Comments must be received on or before
November 20, 2015.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) numbers: Docket No. [Docket No. FMCSA-1999-
5578; FMCSA-1999-5748; FMCSA-2002-12844; FMCSA-2003-15268; FMCSA-2003-
15892; FMCSA-2004-17984; FMCSA-2005-20560; FMCSA-2005-21711; FMCSA-
2006-26653; FMCSA-2007-27515; FMCSA-2007-27897; FMCSA-2007-29019;
FMCSA-2009-0121; FMCSA-2009-0154; FMCSA-2009-0206; FMCSA-2011-0057;
FMCSA-2011-0124; FMCSA-2011-0189; FMCSA-2013-0028; FMCSA-2013-0029;
FMCSA-2013-0030; FMCSA-2013-0165; FMCSA-2013-0166], using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and
5 p.m., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number for this notice. Note that DOT posts all comments
received without change to http://www.regulations.gov, including any
personal information included in a comment. Please see the Privacy Act
heading below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Federal Docket Management System (FDMS) is
available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the Federal Docket
Management System (FDMS) published in the Federal Register on January
17, 2008 (73 FR 3316).

FOR FURTHER INFORMATION CONTACT: Charles A. Horan, III, Director,
Carrier, Driver and Vehicle Safety Standards,<PHONE_NUMBER>,
<EMAIL_ADDRESS>FMCSA, Department of Transportation, 1200 New
Jersey Avenue SE., Room W64-224, Washington, DC 20590-0001. Office
hours are from 8:30 a.m. to 5 p.m.

Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to or greater than the level that would be achieved absent
such exemption.'' The procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

Exemption Decision

    This notice addresses 64 individuals who have requested renewal of
their exemptions in accordance with FMCSA procedures. FMCSA has
evaluated these 64 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. Each
individual is identified according to the renewal date.
    The exemptions are extended subject to the following conditions:
(1) That each individual has a physical examination every year (a) by
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the requirements in 49 CFR 391.41(b)(10),
and (b) by a medical examiner who attests that the individual is
otherwise physically qualified under 49 CFR 391.41; (2) that each
individual provides a copy of the ophthalmologist's or optometrist's
report to the medical examiner at the time of the annual medical
examination; and (3) that each individual provide a copy of the annual
medical certification to the employer for retention in the driver's
qualification file and retains a copy of the certification on his/her
person while driving for presentation to a duly authorized Federal,
State, or local enforcement official. Each exemption will be valid for
two years unless rescinded earlier by FMCSA. The exemption will be
rescinded if: (1) The person fails to comply with the terms and
conditions of the exemption; (2) the exemption has resulted in a lower
level of safety than was maintained before it was granted; or (3)
continuation of the exemption would not be consistent with the goals
and objectives of 49 U.S.C. 31136(e) and 31315.

Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. The following group(s) of
drivers will receive renewed exemptions effective in the month of
November and are discussed below.
    As of November 6, 2015, and in accordance with 49 U.S.C. 31136(e)
and 31315, the following 31 individuals have satisfied the conditions
for obtaining a renewed exemption from the vision requirements (68 FR
37197; 68 FR 48989; 70 FR 17504; 70 FR 30997; 70 FR 42615; 70 FR 48797;
70 FR 61493; 72 FR 8417; 72 FR 21313; 72 FR 32703; 72 FR 36099; 72 FR
39879; 72 FR 40360; 72 FR 40362; 72 FR 52419; 72 FR 54971; 74 FR 26461;
74 FR 26464; 74 FR 34394; 74 FR 34630; 74 FR 37295; 74 FR 41971; 74 FR
43217; 74 FR 48343; 74 FR 49069; 74 FR 57551; 76 FR 18824; 76 FR 29024;
76 FR 34136; 76 FR 37168; 76 FR 37173; 76 FR 53708; 76 FR 54530; 76 FR
55463; 76 FR 55465; 76 FR 62143; 76 FR 66123; 76 FR 67246; 78 FR 27281;
78 FR 34143; 78 FR 41188; 78 FR 41975; 78 FR 47818; 78 FR 52602; 78 FR
56986; 78 FR 57679; 78 FR 63307; 78 FR 77782; 78 FR 78477; 79 FR 24298;
79 FR 53708):

Martin R. Anaya (NM)
Kevan M. Burke (PA)
Thomas F. Caithamer (IL)
Juan Carranco (TX)
Westcott Clarke (MA)
James J. Doan (PA)
Kenneth J. Fisk (MI)
James E. Fix (SC)
James E. Goodman (AL)
James P. Greene (NY)
Bradley O. Hart (UT)
Randy L. Huelster (OK)
Jesus J. Huerta (NV)
Roger D. Kloss (IL)
Michael A. Lawson (KY)
Steven R. Lechtenberg (NE)
Joseph L. Mast (OR)
David Matos (NY)
Jesse R. McClary, Sr. (MO)
Roy L. Morgan (IL)
Earl R. Neugerbauer (CO)
Steven D. O'Donnell (NJ)
Robert M. Pickett II (MI)
Gerald J. Shamla (MN)
Steven C. Sheeder (IA)
Halman Smith (DE)
Jerry W. Stanfill (AR)
Brian C. Tate (OH)
Scott C. Teich (MN)
Bruce E. Thulin (NE)
Virgil E. Walker (TX)

    The drivers were included in one of the following dockets: Docket
Nos. FMCSA-2003-15268; FMCSA-2005-20560; FMCSA-2005-21711; FMCSA-2006-
26653; FMCSA-2007-27515; FMCSA-2007-27897; FMCSA-2009-0121; FMCSA-2009-
0154; FMCSA-2009-0206; FMCSA-2011-0057; FMCSA-2011-0124; FMCSA-2011-
0189; FMCSA-2013-0028; FMCSA-2013-0029; FMCSA-2013-0030; FMCSA-2013-
0165. Their exemptions are effective as of November 6, 2015 and will
expire on November 6, 2017.
    As of November 25, 2015, and in accordance with 49 U.S.C. 31136(e)
and 31315, the following individual, Dennis E. White (PA), has
satisfied the conditions for obtaining a renewed exemption from the
vision requirements (78 FR 62935; 78 FR 76395):
    The driver is included in the following docket: Docket Nos. FMCSA-
2013-0166. Their exemption is effective as of November 25, 2015 and
will expire on November 25, 2017.
    As of November 26, 2015, and in accordance with 49 U.S.C. 31136(e)
and 31315, the following individual, Albert M. Divella (NV), has
satisfied the conditions for obtaining a renewed exemption from the
vision requirements (78 FR 62935; 78 FR 76395).
    The driver is included in the following docket: Docket No. FMCSA-
2013-0166. Their exemption is effective as of November 26, 2015 and
will expire on November 26, 2017.
    As of November 28, 2015, and in accordance with 49 U.S.C. 31136(e)
and 31315, the following 17 individuals have satisfied the conditions
for obtaining a renewed exemption from the vision requirements (69 FR
33997; 69 FR 61292; 70 FR 48797; 70 FR 61493; 71 FR 55820; 72 FR 39879;
72 FR 52421; 72 FR 54971; 72 FR 58362; 72 FR 67344; 73 FR 65009; 74 FR
41971; 74 FR 49069; 74 FR 57553; 76 FR 4413; 76 FR 62143; 76 FR 70212):

Robert W. Bequeaith (IA)
Lloyd K. Brown (WY)
Kecia D. Clark-Welch (NC)
Charles A. DeKnikker, Sr. (NV)
Clarence N. Florey, Jr. (PA)
Loren H. Geiken (SD)
John N. Guilford (AL)
John E. Halcomb (GA)
Michael A. Hershberger (OH)
Patrick J. Hogan, Jr. (DE)
Raul Martinez (FL)
Robert A. Miller (KY)
Amilton T. Monteiro (MA)
David G. Oakley (SC)
John S. Olsen (PA)
Thomas J. Prusik (NJ)
Brent L. Seaux (LA)

    The drivers were included in one of the following dockets: Docket
No. FMCSA-2004-17984; FMCSA-2005-21711; FMCSA-2007-27897; FMCSA-2007-
29019. Their exemptions are effective as of November 28, 2015 and will
expire on November 28, 2017.
    As of November 30, 2015, and in accordance with 49 U.S.C. 31136(e)
and 31315, the following 14 individuals

have satisfied the conditions for obtaining a renewed exemption from
the vision requirements (64 FR 27027; 64 FR 40404; 64 FR 51568; 64 FR
66962; 66 FR 63289; 67 FR 68719; 68 FR 2629; 68 FR 52811; 68 FR 61860;
68 FR 64944; 70 FR 48797; 70 FR 61165; 70 FR 61493; 70 FR 67776; 72 FR
64273; 74 FR 62632; 76 FR 70215; 78 FR 64280):

Thomas E. Adams (IN)
Terry J. Aldridge (MS)
Lennie D. Baker, Jr. (NC)
Jerry D. Bridges (TX)
William J. Corder (NC)
Gary R. Gutschow (WI)
James J. Hewitt (WI)
Rodney M. Mimbs (GA)
Walter F. Moniowczak (MI)
James R. Murphy (NY)
Chris A. Ritenour (MI)
Ronald L. Roy (IL)
Thomas E. Walsh (CA)
Kevin P. Weinhold (MA)

    The drivers were included in one of the following dockets: Docket
No. FMCSA-1999-5578; FMCSA-1999-5748; FMCSA-2002-12844; FMCSA-2003-
15892; FMCSA-2005-21711. Their exemptions are effective as of November
30, 2015 and will expire on November 30, 2017.
    Each of the 64 applicants listed in the groups above has requested
renewal of the exemption and has submitted evidence showing that the
vision in the better eye continues to meet the requirement specified at
49 CFR 391.41(b)(10) and that the vision impairment is stable. In
addition, a review of each record of safety while driving with the
respective vision deficiencies over the past two years indicates each
applicant continues to meet the vision exemption requirements.
    These factors provide an adequate basis for predicting each
driver's ability to continue to drive safely in interstate commerce.
Therefore, FMCSA concludes that extending the exemption for each
renewal applicant for a period of two years is likely to achieve a
level of safety equal to that existing without the exemption.

Request for Comments

    FMCSA will review comments received at any time concerning a
particular driver's safety record and determine if the continuation of
the exemption is consistent with the requirements at 49 U.S.C. 31136(e)
and 31315. However, FMCSA requests that interested parties with
specific data concerning the safety records of these drivers submit
comments by November 20, 2015.
    FMCSA believes that the requirements for a renewal of an exemption
under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially
granting the renewal and then requesting and evaluating, if needed,
subsequent comments submitted by interested parties. As indicated
above, the Agency previously published notices of final disposition
announcing its decision to exempt these 64 individuals from the vision
requirement in 49 CFR 391.41(b)(10). The final decision to grant an
exemption to each of these individuals was made on the merits of each
case and made only after careful consideration of the comments received
to its notices of applications. The notices of applications stated in
detail the qualifications, experience, and medical condition of each
applicant for an exemption from the vision requirements. That
information is available by consulting the above cited Federal Register
publications.
    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

Submitting Comments

    You may submit your comments and material online or by fax, mail,
or hand delivery, but please use only one of these means. FMCSA
recommends that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that FMCSA
can contact you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov and
in the search box insert the docket numbers FMCSA-1999-5578; FMCSA-
1999-5748; FMCSA-2002-12844; FMCSA-2003-15268; FMCSA-2003-15892; FMCSA-
2004-17984; FMCSA-2005-20560; FMCSA-2005-21711; FMCSA-2006-26653;
FMCSA-2007-27515; FMCSA-2007-27897; FMCSA-2007-29019; FMCSA-2009-0121;
FMCSA-2009-0154; FMCSA-2009-0206; FMCSA-2011-0057; FMCSA-2011-0124;
FMCSA-2011-0189; FMCSA-2013-0028; FMCSA-2013-0029; FMCSA-2013-0030;
FMCSA-2013-0165; FMCSA-2013-0166 and click the search button. When the
new screen appears, click on the blue ``Comment Now!'' button on the
right hand side of the page. On the new page, enter information
required including the specific section of this document to which each
comment applies, and provide a reason for each suggestion or
recommendation. If you submit your comments by mail or hand 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 comments by
mail and would like to know that they reached the facility, please
enclose a stamped, self-addressed postcard or envelope.
    We will consider all comments and material received during the
comment period and may change this proposed rule based on your
comments. FMCSA may issue a final rule at any time after the close of
the comment period.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble, To submit your comment online, go to http://www.regulations.gov and in the search box insert the docket number
FMCSA-1999-5578; FMCSA-1999-5748; FMCSA-2002-12844; FMCSA-2003-15268;
FMCSA-2003-15892; FMCSA-2004-17984; FMCSA-2005-20560; FMCSA-2005-21711;
FMCSA-2006-26653; FMCSA-2007-27515; FMCSA-2007-27897; FMCSA-2007-29019;
FMCSA-2009-0121; FMCSA-2009-0154; FMCSA-2009-0206; FMCSA-2011-0057;
FMCSA-2011-0124; FMCSA-2011-0189; FMCSA-2013-0028; FMCSA-2013-0029;
FMCSA-2013-0030; FMCSA-2013-0165; FMCSA-2013-0166 and click ``Search.''
Next, click ``Open Docket Folder'' and you will find all documents and
comments related to the proposed rulemaking.

    Issued on: October 8, 2015.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-26699 Filed 10-20-15; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 80, Number 240 (Tuesday, December 15, 2015)]
[Notices]
[Pages 77638-77640]
[FR Doc No: 2015-31397]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-1694]

Determination of Regulatory Review Period for Purposes of Patent
Extension; Trivascular Ovation Abdominal Stent Graft System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for TRIVASCULAR OVATION ABDOMINAL STENT GRAFT
SYSTEM and is publishing this notice of that determination as required
by law. FDA has made the determination because of the submission of an
application to the Director of the U.S. Patent and Trademark Office
(USPTO), Department of Commerce, for the extension of a patent which
claims that medical device.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic

or written comments and ask for a redetermination by February 16, 2016.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by June 13, 2016. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-E-1694 for Determination of Regulatory Review Period for
Purposes of Patent Extension; TRIVASCULAR OVATION ABDOMINAL STENT GRAFT
SYSTEM. Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device, TRIVASCULAR
OVATION ABDOMINAL STENT GRAFT SYSTEM. TRIVASCULAR OVATION ABDOMINAL
STENT GRAFT SYSTEM is indicated for the treatment of patients with
abdominal aortic aneurysms having vascular morphology suitable for
endovascular repair. Subsequent to this approval, the USPTO received a
patent term restoration application for TRIVASCULAR OVATION ABDOMINAL
STENT GRAFT SYSTEM (U.S. Patent No. 6,395,019) from TriVascular, Inc.,
and the USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated March 20,
2014, FDA advised the USPTO that this medical device had undergone a
regulatory review period and that the approval of TRIVASCULAR OVATION
ABDOMINAL STENT GRAFT SYSTEM represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
TRIVASCULAR OVATION ABDOMINAL STENT GRAFT SYSTEM

is 3,607 days. Of this time, 3,429 days occurred during the testing
phase of the regulatory review period, while 178 days occurred during
the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: November 22, 2002. The applicant claims
that the investigational device exemption (IDE) required under section
520(g) of the FD&C Act for human tests to begin became effective on
October 24, 2002. However, FDA records indicate that the IDE was
determined substantially complete for clinical studies to have begun on
November 22, 2002, which represents the IDE effective date.
    2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): April
11, 2012. FDA has verified the applicant's claim that the premarket
approval application (PMA) for TRIVASCULAR OVATION ABDOMINAL STENT
GRAFT SYSTEM (PMA P120006) was initially submitted April 11, 2012.
    3. The date the application was approved: October 5, 2012. FDA has
verified the applicant's claim that PMA P120006 was approved on October
5, 2012.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,802 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Submit petitions electronically to http://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-31397 Filed 12-14-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: March 19, 2010 (Volume 75, Number 53)]
[Notices]
[Page 13285-13286]
[DOCID:fr19mr10-73]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0194; FRL-8814-9]

Centers for Disease Control and Prevention; Transfer of Data

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces that pesticide related information
submitted to EPA's Office of Pesticide Programs (OPP) pursuant to the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the
Federal Food, Drug, and Cosmetic Act (FFDCA), including information
that may have been claimed as Confidential Business Information (CBI)
by the submitter, will be transferred to the Centers for Disease
Control and Prevention in accordance with 40 CFR 2.309(c) and
2.308(h)(2). The Centers for Disease Control and Prevention will
perform work for OPP under an Interagency Agreement (IAG). Access to
this information will enable Centers for Disease Control and Prevention
to fulfill the obligations of the IAG.

DATES: The Centers for Disease Control and Prevention will be given
access to this information on or before March 29, 2010.

FOR FURTHER INFORMATION CONTACT: Felicia Croom, Information Technology
and Resources Management Division (7502P), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action applies to the public in general. As such, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0194. Publicly available
docket materials are available either in the electronic docket at
http://www.regulations.gov, or, if only available in hard copy, at the
Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-
4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The hours of operation of this Docket Facility are from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

II. Contractor Requirements

    Under this IAG, which supports the OPP's regulatory efforts, the
Centers for Disease Control and Prevention will support ongoing effort
to coordinate and understand efficacy determinations for products used
to control Pests of Public Health Significance (as specified in PR
Notice 2002-1 at: http://www.epa.gov/opppmsd1/PR_Notices/pr 2002-1).
    The OPP has determined that the IAG involves work that is being
conducted in connection with FIFRA, in that pesticide chemicals will be
the subject of certain evaluations to be made under this IAG. These
evaluations may be used in subsequent regulatory decisions under FIFRA.
    Some of this information may be entitled to confidential treatment.
The information has been submitted to EPA under sections 3, 4, 6, and 7
of FIFRA and under sections 408 and 409 of FFDCA.
    In accordance with the requirements of 40 CFR 2.309(c), 2.307(h),
and 2.308(h)(2), this IAG with the Centers for Disease Control and
Prevention, prohibits use of the information for any purpose not
specified in the IAG; prohibits disclosure of the information to a
third party without prior written approval from the Agency; and
requires that each official and employee of the subcontractor sign an
agreement to protect the information from

unauthorized release and to handle it in accordance with the FIFRA
Information Security Manual. In addition, the Centers for Disease
Control and Prevention are required to submit for EPA approval a
security plan under which any CBI will be secured and protected against
unauthorized release or compromise. No information will be provided to
the Centers for Disease Control and Prevention until the requirements
in this document have been fully satisfied. Records of information
provided under this IAG will be maintained by EPA Project Officers for
this contract. All information supplied to the Centers for Disease
Control and Prevention by EPA for use in connection with this IAG will
be returned to EPA when the Centers for Disease Control and Prevention
have completed their work.

List of Subjects

    Environmental protection, Business and industry, Government
contracts, Government property, Security measures.

    Dated: March 3, 2010.
 Oscar Morales,
Director, Information Technology and Resources Management Division,
Office of Pesticide Programs.
[FR Doc. 2010-5968 Filed 3-18-10; 8:45 a.m.]
BILLING CODE 6560-50-S


4 CPA Tolerance Reregistration Eligibility Decision ( TRED) SMART Meeting Minutes Date: October 24, 2002 Time 1: 00  1: 45 PM Location: Room 650, Crystal Mall 2 Introductions Status Report  The RED was completed before the implementation of FQPA. A TRED needs to be completed to satisfy the requirements of FQPA. Therefore, the review team will be working on the dietary exposure aspect of the pesticide's use. ( There are no residential uses of 4 CPA.)

Lead Risk Assessor ( Carol Christensen) reported that 4 CPA will be assessed through the inerts/ low toxicity review process rather than the traditional SARC ( science review committee) process. This should greatly expedite the risk assessment.

Currently, there are two tolerances, one for tomatoes and one for mung beans. The registrant petitioned the Agency to delete the tomato tolerance and reduce the mung bean tolerance from 2.0 ppm to 0.2 ppm at the time of the RED. Further, there is a metabolite in the tolerance expression that was proposed to be removed. None of the tolerance changes have been accomplished to date.

Dick Otten stated that there has been no new data generated or submitted since the time of the RED. He reiterated that the only use is an indoor operation, with no outdoor use.

Several questions were posed by OPP staff, about how much 4 CPA is now used annually, how often, at how many production sites, and how the ( effluent and landfill) disposal practice occurs. Mr. Otten indicated that he will get updated information on usage and attempt to find the old video that demonstrates how the process is done. In the past, one batch of active ingredient that lasts for several years was manufactured. Approximately 50 lbs of a. i. is used annually at one site. It is not clear if one or more sites have been added since the RED was completed.

In addition to quantitative use information, Mr. Otten agreed to look for any additional information on metabolism of 4 CPA and any incident data.

Attendee list:

EPA: Registrant: Carol Christensen Richard Otten David Anderson Ken Dockter Mark Corbin Pauline Wagner Barry O'Keefe Mark Howard


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF PREVENTION,

 PESTICIDES AND

TOXIC SUBSTANCES

MEMORANDUM

DATE:		June 18, 2008

SUBJECT:	Alkyl Amine Hydrochloride:  EPA Response to Public Comments on
Preliminary Work Plan (PWP).  PC Code 069152, Case No. 3051

FROM:	Heather Garvie, Chemical Review Manager

		Regulatory Management Branch II

		Antimicrobials Division (7510P)

THRU:		Mark Hartman, Branch Chief

		Diane Isbell, Team Leader

		Regulatory Management Branch II

		Antimicrobials Division (7510P)

The Agency received one comment during the 90-day public comment period
for the Registration Review Preliminary Work Plan (PWP) for Alkyl Amine
Hydrochloride.  The full comment can be found on the alkyl amine
hydrochloride docket at:    HYPERLINK "http://www.regulations.gov"
www.regulations.gov ; docket ID:  EPA-HQ-OPP-2007-1039.  The comment was
submitted by the American Chemistry Council (ACC) in a document dated
March 11, 2008.  In summary, the comment states that the Agency has used
a Registration Review Summary document to impose a new generic data
requirement (90-day subchronic inhalation study) which ACC feels is
inconsistent with current regulations.  An excerpt from page 3 of the
ACC comment reads as follows:

“The registration review process cannot be used as a vehicle for
rulemaking. Yet this document plainly asserts that the Agency is
changing the data needed to support registrations for all material
preservatives. The language above stands in contrast to the current
regulation – which is legally binding on EPA – which specifies that
an inhalation toxicology study is:

Required if use may result in repeated inhalation exposure at a
concentration which is likely to be toxic. 40 CFR 161.340(6).

A review of EPA’s updated toxicity data requirements for conventional
pesticides provides a concurring but somewhat more comprehensive
description of the conditions appropriate to this requirement.

Required if there is the likelihood of significant repeated inhalation
exposure to the pesticide as a gas, vapor, or aerosol.

40 CFR 158.500(e)(14). Further, the new requirement imposed in the
Registration Review summary document is inconsistent with the Agency’s
clear technical guidance as identified by EPA/OPP/HED SOP 2002.01 (Aug
15, 2002). That guidance, while designed to explain where waivers for
subchronic inhalation toxicity studies may be appropriate, identifies
that consideration first must be given to whether there is potential for
significant human inhalation hazard and then identifies circumstances in
which such potential is minimal or when testing otherwise would be
inappropriate. That guidance identifies, for example, that it would be
inappropriate to conduct subchronic inhalation toxicity studies on
products that are non-volatile or otherwise not made inhalable.”

The Agency Response is as follows:

	The Agency anticipates that additional toxicity and exposure data will
be needed for the registration review of alkyl amine hydrochloride.  In
addition, the EPA anticipates that an occupational and residential
handler assessment will need to be conducted for the dermal and
inhalation routes of exposure, since no specific quantitative
occupational or residential risk assessments are currently available for
alkyl amine hydrochloride.  The Agency believes that it needs to conduct
risk assessments to ensure that the alkyl amine hydrochloride
registration review case meets the registration and safety standards
established by FIFRA, as amended by FQPA and the Federal Food, Drug and
Cosmetic Act (FFDCA).

	The Agency acknowledges that the registration review process is not a
vehicle for rulemaking and the Agency is not attempting to institute a
new data requirement generically for material preservatives.  The Agency
recognizes that the specific wording in the PWP to which ACC points (The
following language appears in the PWP under the Risk Assessment Status &
Anticipated Risk Assessment and Data Needs: “At this time the Agency
anticipates that short- and intermediate-term dermal occupational
assessments as well as an inhalation assessment will be needed to assess
exposure for open situations in manufacturing settings for all material
preservative uses.”) may have been confusing and the Agency has
changed that language in the Final Work Plan (FWP) under the Risk
Assessment and Data Needs section to clarify that the data needs
identified in the PWP are specific to the active ingredient, alkyl amine
hydrochloride.  Additionally, ACC stated its belief that the Agency
imposed the data requirement in the PWP.  That did not occur.  In the
PWP, the Agency stated what it knows about that particular antimicrobial
pesticide and what additional risk analyses and data or information it
believes are needed to make a registration review decision.  The Agency
will comply with both FIFRA and its Registration Review regulations in
imposing any data requirements for Registration Review.

	Alkyl amine hydrochloride is an antimicrobial pesticide used for
material preservative use sites such as: resins, paints, adhesives,
printing inks and dispersed colors, caulks, spackling, joint cements,
sealants, grouts, and wallboard compounds.  In manufacturing situations,
occupational handlers are expected to be exposed via the dermal and
inhalation exposure route to alkyl amine hydrochloride.  In the 1992 RED
issued for alkyl amine hydrochloride, the Agency concluded that when the
pesticide was used with Personal Protective Equipment (PPE) as directed
by the label, the occupational risks to alkyl amine hydrochloride would
be minimal.  Since the 1992 RED, the Agency identified new exposure
databases (PHED and CMA) that have more adequately characterized
specific antimicrobial exposures (e.g. paint).  The Agency has found
that for certain antimicrobial chemical product exposures, such as
paint, that there may be risk concerns to both occupational and
residential handlers even when PPE label restrictions are imposed.
Therefore, the Agency needs to quantitatively assess risk.

	The inhalation exposure assessment can not be assessed at this time due
to a lack of 90-day inhalation toxicity data.  The 90-day inhalation
toxicity study for alkyl amine hydrochloride is needed based on the
observed toxicity of the chemical from the available data and the lack
of hazard characterization by the inhalation route.  When toxicity is
observed with a pesticide chemical but there are no data to assess risk
from a major route of exposure (in this case, inhalation exposure to
breathable particles from airless spraying), a study by that route of
exposure is generally needed.  Although the chemical has a low vapor
pressure, that alone does not mitigate the need for testing for exposure
to aerosols of the chemical unless it can be demonstrated (per the HED
SOP 2002.01) that the aerosol is essentially non-inhalable (i.e. that >
99% of the particles are > 100 microns in diameter). In addition,
because alkyl amine hydrochloride can be used in both residential and
occupational settings in airless spraying applications, there is the
likelihood of significant repeated inhalation exposure.

	Under the authority of FIFRA Section 3(c)(2)(B), the Agency can require
data it deems necessary to support a pesticide registration.   FIFRA
Sections 3(g)(2)(A) and (B) direct the Agency to use FIFRA Section
3(c)(2)(B) Data Call-In (DCI) authority to require any data necessary
for a registration review.  The Agency’s Registration Review
regulations at 40 CFR Part 155.40 et seq. include provisions regarding
the use of FIFRA Section 3(c)(2)(B) to obtain data necessary for
registration review.

40 CFR Parts 158 and 161 also specify the types and minimum amounts of
data and information that an applicant for registration, amended
registration or reregistration must submit or cite in support of such an
application.  A 90-day subchronic inhalation test is required if the use
may result in repeated inhalation exposure at a concentration likely to
be toxic (See 40 CFR 158.500 and 40 CFR 161.340).  In addition, 40 CFR
Part 158 and Part 161 state that the Agency has the authority to require
any additional data it deems necessary in order to sufficiently evaluate
the potential of the product to cause unreasonable adverse effects on
man or the environment (See 40 CFR 158.75 and 40 CFR 161.75(a)).

The PWP for alkyl amine hydrochloride does not impose any additional
data on the registrants, rather it lays out the exposure scenarios for
this particular active ingredient and states why the Agency believes
that certain data are needed in order to assess the risks associated
with the use of this chemical as an active ingredient in antimicrobial
products.  The registration review program is intended to make sure
that, as the ability to assess and reduce risk evolves and as policies
and practices change, all registered pesticides continue to meet the
statutory standard of no unreasonable adverse effects.

Finally, alkyl amine hydrochloride registrants will not be required to
generate or submit any new data for the alkyl amine hydrochloride
registration review until a DCI is issued for alkyl amine hydrochloride.
 The DCI will not be issued until the Final Work Plan (FWP) is complete
and the DCIs have been cleared for release by OMB.

 HED Standard Operating Procedure. Guidance: Waiver Criteria for
Multiple-Exposure Inhalation Toxicity Studies, August 15, 2002.

 PAGE

 PAGE   1


[Federal Register Volume 81, Number 241 (Thursday, December 15, 2016)]
[Notices]
[Pages 90855-90857]
[FR Doc No: 2016-30146]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0390]

Use of Electronic Informed Consent--Questions and Answers;
Guidance for Institutional Review Boards, Investigators, and Sponsors;
Availability

AGENCY: Food and Drug Administration and Office for Human Research
Protections, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA) and the Office for
Human Research Protections (OHRP), Department of Health and Human
Services (HHS), are announcing the availability of a guidance entitled
``Use of Electronic Informed Consent--Questions and Answers.'' The
guidance is intended for institutional review boards (IRBs),
investigators, and sponsors engaged in or responsible for oversight of
human subject research under HHS and/or FDA regulations. The guidance
provides recommendations on the use of electronic systems and processes
that may employ multiple electronic media to obtain informed consent
for both HHS-regulated human subject research and FDA-regulated
clinical investigations of medical products, including human drug and
biological products, medical devices, and combinations thereof. This
guidance finalizes the draft guidance entitled ``Use of Electronic
Informed Consent in Clinical Investigations--Questions and Answers''
issued in March 2015.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-D-0390 for ``Use of Electronic Informed Consent--Questions and
Answers; Guidance for Institutional Review Boards, Investigators, and
Sponsors; Availability.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    See section III of the SUPPLEMENTARY INFORMATION section for
submitting written requests for single copies of this guidance and for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Cheryl Grandinetti, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3348, Silver Spring, MD 20993-0002, 301-
796-2500; Nicole Wolanski, Office of Good Clinical Practice, Office of
Special Medical Programs, Office of Medical Products and Tobacco, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5108,
Silver Spring, MD 20993,<PHONE_NUMBER>; Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911; Irfan Khan, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
3459, Silver Spring, MD 20993, 1-800-638-2041 or<PHONE_NUMBER>; or Irene
Stith-Coleman, Office for Human Research Protections, 1101 Wootton
Pkwy., suite 200, Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA and OHRP are announcing the availability of a guidance entitled
``Use of Electronic Informed Consent--Questions and Answers.'' The
guidance is intended for IRBs, investigators, and sponsors responsible
for oversight of human subject research under HHS and/or FDA
regulations. The guidance provides recommendations on the use of
electronic systems and processes that

may employ multiple electronic media to obtain informed consent for
both HHS-regulated human subject research and FDA-regulated clinical
investigations of medical products, including human drug and biological
products, medical devices, and combinations thereof. In particular, the
guidance provides recommendations on procedures that may be followed
when using an electronic informed consent (eIC) to help: (1) Ensure
protection of the rights, safety, and welfare of human subjects; (2)
facilitate the subject's comprehension of the information presented
during the eIC process; (3) ensure that appropriate documentation of
consent is obtained when electronic systems and processes that may
employ multiple electronic media are used to obtain informed consent;
and (4) ensure the quality and integrity of eIC data included in FDA
applications and made available to FDA during inspections.
    In the Federal Register of March 9, 2015 (80 FR 12496), FDA
announced the availability of a draft guidance entitled ``Use of
Electronic Informed Consent in Clinical Investigations--Questions and
Answers.'' FDA received a number of comments on the draft guidance. In
response to these comments, this guidance provides further
clarification on: (1) How to present information in the eIC to the
subject; (2) how and where to conduct the eIC process; (3) how and when
questions from subjects should be answered; (4) steps that may be taken
to facilitate the subject's understanding; (5) how to convey additional
information to the subject during the course of the research; (6) how
to use electronic signatures to document eIC; (7) how to verify the
identity of the subjects who will be electronically signing the
informed consent; (8) how to use electronic informed consent for
pediatric studies; (9) how to provide copies of the eIC to the subject;
(10) steps that may be taken to ensure privacy, security, and
confidentiality of the eIC information; (11) how to obtain Health
Insurance Portability and Accountability Act authorizations for
research electronically; (12) what eIC materials the investigator
should submit to the IRB; (13) what the IRB's responsibilities are in
the eIC process; (14) the eIC documentation required for FDA submission
with applications; (15) steps to ensure that eIC materials are archived
appropriately for FDA-regulated clinical investigations; and (16) what
eIC materials or documents FDA will require during an inspection.
    In addition, in the Federal Register of March 9, 2015 (80 FR
12497), OHRP asked for public comment on whether OHRP should adopt the
positions and recommendations proposed in the draft guidance for
research regulated under the HHS protection of human subjects
regulations, 45 CFR part 46, and whether OHRP and FDA should issue a
joint guidance on this topic. In response to these comments, the final
guidance was developed in collaboration with FDA and OHRP and is issued
as a joint final guidance.
    To enhance human subject protection and reduce regulatory burden,
OHRP and FDA have been actively working to harmonize the Agencies'
regulatory requirements and guidance for human subject research. This
guidance was developed as a part of these efforts. OHRP and FDA believe
that it will be helpful to the regulated community to issue a joint
guidance, which will clearly demonstrate the Agencies' collaborative
approach to the topic of electronic informed consent.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA and OHRP on the use of electronic informed
consent. It does not establish any rights for any person and is not
binding on OHRP, FDA, or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21
CFR part 11 related to electronic records and electronic signatures
have been approved under OMB control number 0910-0303; the collections
of information in 21 CFR parts 50 and 56 related to protection of human
subjects and to IRBs have been approved under OMB control number 0910-
0755; the collections of information in 21 CFR 56.115 related to IRB
recordkeeping requirements, which include requirements for records
related to informed consent, have been approved under OMB control
number 0910-0130; the collections of information in 21 CFR part 312
have been approved under OMB control number 0910-0014; and the
collections of information in 21 CFR part 812 have been approved under
OMB control number 0910-0078. The collections of information related to
the protection of human subjects under 45 CFR part 46 and to IRB
recordkeeping under 45 CFR 46.115 have been approved under OMB control
number 0990-0260.

III. Addresses for Written Requests

    Submit written requests for single copies of this guidance and for
electronic access to the guidance document to one of the following
Centers.

----------------------------------------------------------------------------------------------------------------
              Center                          Address                 Telephone            Other information
----------------------------------------------------------------------------------------------------------------
Division of Drug Information,       10001 New Hampshire Ave.,   .....................  .........................
 Center for Drug Evaluation and      Hillandale Building, 4th
 Research, Food and Drug             Floor, Silver Spring, MD
 Administration.                     20993-0002.
Office of Good Clinical Practice,   10903 New Hampshire Ave.,   .....................  .........................
 Office of Special Medical           Bldg. 32, rm. 5103,
 Programs, Office of Medical         Silver Spring, MD 20993-
 Products and Tobacco, Food and      0002.
 Drug Administration.
Office for Human Research           1101 Wootton Pkwy., suite   .....................  .........................
 Protections.                        200, Rockville, MD 20852.
Center for Biologics Evaluation     10903 New Hampshire Ave.,   240-7911-402.........  .........................
 and Research, Food and Drug         Bldg. 71, rm. 7301,
 Administration.                     Silver Spring, MD 20993-
                                     0002.
Center for Devices and              10903 New Hampshire Ave.,   1-800-638-2041 or 301- Send one self-addressed
 Radiological Health, Food and       Bldg. 66, rm. 4621,         796-7100.              adhesive label to assist
 Drug Administration.                Silver Spring, MD 20993.                           that office in
                                                                                processing your
                                                                                requests.
----------------------------------------------------------------------------------------------------------------

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219433.htm, http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm, http://www.hhs.gov/ohrp/newsroom/rfc/index.html, or http://www.regulations.gov.

Leslie Kux,
Assistant Commissioner for Policy, Food and Drug Administration.
Karen B. DeSalvo,
Acting Assistant Secretary for Health, Department of Health and Human
Services.
[FR Doc. 2016-30146 Filed 12-14-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: January 20, 2010 (Volume 75, Number 12)]
[Notices]
[Page 3223]
[DOCID:fr20ja10-60]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EF10-4-000]

Southwestern Power Administration; Notice of Filing

January 8, 2010.
    Take notice that on January 5, 2010, the Deputy Secretary of the
Department of Energy, pursuant to the authority vested by sections
301(b), 302(a), 402(e), 641, 642, 643, and 644, and by Delegation Order
Nos. 00-037.00 (December 6, 2001) and 00-001.00C (January 31, 2007),
confirmed, approved, and placed in effect on an interim basis in Rate
Order SWPA-62, Southwestern Power Administration Integrated System
Rates, Rate Schedule P-09, Wholesale Rates for Hydro Peaking Power,
Rate Schedule NFTS-09, Wholesale Rates for Non-Federal Transmission/
Interconnection Facilities Service, and Rate Schedule EE-09, Wholesale
Rate for Excess Energy, for period January 1, 2010 through September
30, 2013.
    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, 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 e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on February 4, 2010.

Kimberly D. Bose,
 Secretary.
[FR Doc. 2010-918 Filed 1-19-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 18 (Friday, January 27, 2023)]
[Rules and Regulations]
[Pages 5250-5251]
[FR Doc No: 2023-01536]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-1317; Airspace Docket No. 22-ACE-19]
RIN 2120-AA66

Amendment of Class E Airspace; Multiple Missouri Towns

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends the Class E airspace at Hannibal, MO;
Monroe City, MO; and Monticello, MO. This action is the result of
airspace reviews conducted as part of the decommissioning of the Quincy
very high frequency (VHF) omnidirectional range (VOR) as part of the
VOR Minimal Operational Network (MON) Program. The name of CPT Ben
Smith Airfield-Monroe City Airport, Monroe City, MO, is also being
updated to coincide with the FAA's aeronautical database.

DATES: Effective 0901 UTC, April 20, 2023. The Director of the Federal
Register approves this incorporation by reference action under 1 CFR
part 51, subject to the annual revision of FAA Order JO 7400.11 and
publication of conforming amendments.

ADDRESSES: FAA Order JO 7400.11G, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends the Class E airspace extending upward from 700 feet above
the surface at Hannibal Regional Airport, Hannibal, MO; CPT Ben Smith
Airfield-Monroe City Airport, Monroe City, MO; and Lewis County
Regional Airport, Monticello, MO, to support instrument flight rule
operations at these airports.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (87 FR 66630; November 4, 2022) for Docket No. FAA-2022-1317
to amend the Class E airspace at Hannibal, MO; Monroe City, MO; and
Monticello, MO. Interested parties were invited to participate in this
rulemaking effort by submitting written comments on the proposal to the
FAA. No comments were received.
    Class E airspace designations are published in paragraph 6005 of
FAA Order JO 7400.11G, dated August 19, 2022, and effective September
15, 2022, which is incorporated by reference in 14 CFR 71.1. The Class
E airspace designations listed in this document will be published
subsequently in FAA Order JO 7400.11.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order JO 7400.11G, Airspace Designations
and Reporting Points, dated August 19, 2022, and effective September
15, 2022. FAA Order JO 7400.11G is publicly available as listed in the
ADDRESSES section of this document. FAA Order JO 7400.11G lists Class
A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to 14 CFR part 71:
    Amends the Class E airspace extending upward from 700 feet above
the surface to within a 6.4-mile (decreased from a 6.5-mile) radius of
Hannibal Regional Airport, Hannibal, MO;
    Amends the Class E airspace extending upward from 700 feet above
the surface at CPT Ben Smith Airfield-

Monroe City Airport, Monroe City, MO, by removing the Quincy VORTAC and
associated extension from the airspace legal description; and updates
the name of the airport (previously Monroe City Regional Airport) to
coincide with the FAA's aeronautical database;
    And amends the Class E airspace extending upward from 700 feet
above the surface at Lewis County Regional Airport, Monticello, MO, by
removing the Quincy VORTAC from the airspace legal description.
    This action is due to airspace reviews conducted as part of the
decommissioning of the QUINCY VOR, which provided navigation
information for the instrument procedures at these airports, as part of
the VOR MON Program.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022, and effective September 15, 2022, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ACE MO E5 Hannibal, MO [Amended]

Hannibal Regional Airport, MO
    (Lat. 39[deg]43'31'' N, long. 91[deg]26'38'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Hannibal Regional Airport.
* * * * *

ACE MO E5 Monroe City, MO [Amended]

CPT Ben Smith Airfield-Monroe City Airport, MO
    (Lat. 39[deg]38'04'' N, long. 91[deg]43'37'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.3-mile radius of CPT Ben Smith Airfield-Monroe City
Airport.

ACE MO E5 Monticello, MO [Amended]

Lewis County Regional Airport, MO
    (Lat. 40[deg]07'45'' N, long. 91[deg]40'42'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.3-mile radius of the Lewis County Regional Airport.

    Issued in Fort Worth, Texas, on January 19, 2023.
Martin A. Skinner,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2023-01536 Filed 1-26-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 67 (Friday, April 7, 2023)]
[Notices]
[Page 20876]
[FR Doc No: 2023-07394]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER02-2001-020, ER13-2230-001, ER16-722-000, ER21-2089-000,
ER12-2402-000, ER12-2403-000, ER12-2400-000]

Electric Quarterly Reports, Premier Empire Energy, LLC, Current
Power & Gas Inc., Elephant Energy, LLC, Liberty Power Maryland LLC,
Liberty Power Holdings LLC, Liberty Power District of Columbia LLC;
Notice of Revocation of Market-Based Rate Authority and Termination of
Electric Market-Based Rate Tariff

    On February 22, 2023, the Commission issued an order announcing its
intent to revoke the market-based rate authority of several public
utilities that had failed to file their required Electric Quarterly
Reports.\1\ The Commission directed those public utilities to file the
required Electric Quarterly Reports within 15 days of the date of
issuance of the order or face revocation of their authority to sell
power at market-based rates and termination of their electric market-
based rate tariffs.\2\
---------------------------------------------------------------------------

    \1\ Electric Quarterly Reports, 182 FERC ] 61,113 (2023)
(February 22 Order).
    \2\ Id. at Ordering Paragraph A.
---------------------------------------------------------------------------

    The time period for compliance with the February 22 Order has
elapsed. The above-captioned companies failed to file their delinquent
Electric Quarterly Reports. The Commission hereby revokes, effective as
of the date of issuance of this notice, the market-based rate authority
and terminates the electric market-based rate tariff of each of the
companies who are named in the caption of this order.

    Dated: April 3, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-07394 Filed 4-6-23; 8:45 am]
BILLING CODE 6717-01-P