[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]
[Notices]
[Pages 27326-27327]
[FR Doc No: 2015-11536]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1306]

Dose Finding of Small Molecule Oncology Drugs; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA), in cosponsorship with the
American Association for Cancer Research (AACR), is announcing a public
workshop entitled ``Dose Finding of Small Molecule Oncology Drugs.''
The purpose of this 2-day workshop is to provide an interdisciplinary
forum to discuss the best practices of dose finding and dose selection
for small molecule kinase inhibitors developed for oncology
indications. The goal is to foster robust scientific discussion to
promote a movement away from the conventional 3+3 dose escalation trial
design and move toward innovative designs that can potentially
incorporate key clinical, pharmacologic, and pharmacometric data and,
when appropriate, nonclinical information to guide dose selection.
Ideally, this workshop will propel a movement toward integrating dose
finding into the entire life cycle of product development as opposed to
confining it to the Phase 1, first-in-human trial based on short-term
safety measures.
    Date and Time: The public workshop will be held on May 18 and 19,
2015, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Washington Court
Hotel, 525 New Jersey Ave. NW., Washington, DC 20001,<PHONE_NUMBER>.
    Contact Persons: Rasika Kalamegham, American Association for Cancer
Research, 1425 K St. NW., Washington, DC 20005,<PHONE_NUMBER>,
<EMAIL_ADDRESS>and Christine Lincoln, Office of Hematology
and Oncology Products, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD,
20993-0002<EMAIL_ADDRESS>    Registration: Registration is free and available on a first-come,
first-served basis. You must register online by May 14, 2015, 5 p.m.
Registration will be handled through AACR. Early registration is
recommended because facilities are limited and, therefore, FDA may
limit the number of participants from each organization. If time and
space permits, onsite registration on the day of the public workshop
will be provided beginning at 7 a.m.
    If you need special accommodations due to a disability, please
contact the Washington Court Hotel no later than May 14, 2015.
    To register for the public workshop, visit https://www.surveymonkey.com/s/WTM2Z57. Please provide complete contact
information for each attendee, including name, title, affiliation,
email, and telephone number. Registrants will receive confirmation
after they have been accepted. Registrants will be notified if they are
on a waiting list.
    Streaming Audiocast of the Public Workshop: This public workshop
will also be available via audiocast. Persons interested in accessing
the audiocast must register online at https://www.surveymonkey.com/s/WTM2Z57. FDA has verified the Web site addresses in this document, but
FDA is not responsible for any subsequent changes to the Web sites
after this document publishes in the Federal Register. Early
registration is recommended because audiocast connections are limited.
Organizations are requested to register all participants but to listen
using one connection per location. After registration, participants
will be sent technical system requirements and connection access
information after May 14, 2015.
    Comments: FDA is holding this public workshop to provide an
interdisciplinary forum to discuss the best practices of dose finding
and dose selection for small molecule kinase inhibitors developed for
oncology indications. To permit the widest possible opportunity to
obtain public comment, FDA is soliciting either electronic or written
comments on all aspects of the public workshop topics. The deadline for
submitting comments related to this public workshop is June 18, 2015.
    Regardless of attendance at the public workshop, you may submit
either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.
    Transcript: As soon as a transcript is available, it will be
accessible at http://www.regulations.gov. It may be viewed at the
Division of Dockets Management (see Comments). A transcript will also
be available in either hardcopy or on CD-ROM, after submission of a
Freedom of Information request. Written requests are to be sent to the
Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
A link to the transcript will also be available approximately 45 days
after the public workshop at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. Select this public
workshop from the posted events list.

SUPPLEMENTARY INFORMATION:

I. Background

    Since the approval of imatinib in 2001, FDA has approved 26 small
molecule kinase inhibitors for the treatment of oncology indications.
For the first several small molecule kinase inhibitors in development,
it was common to see multiple dose-finding trials that evaluated
multiple dose levels and dosing schedules. As additional small molecule
kinase inhibitors entered clinical trials and the familiarity with this
class of drugs increased, the number of dose-finding trials for each
compound reduced in number. Although this may appear to be a product of
increased efficiency in trial design and dose finding, proper doses or
dose ranges appear to not have been identified for approved products,
as evident by the high prevalence of dose reductions observed in
registration trials and the high frequency of postmarketing
requirements to study alternative doses. In some cases, critical cross-
disciplinary information does not appear to be integrated into the
dose-finding process. Given the recent history of approvals based on
the results of early phase trials driven by extraordinary efficacy
data, the incentive for conducting rigorous dose-finding trials may not
be overtly apparent. However, the increasing need for the development
of combination therapy due to resistance to monotherapy and poor
tolerance of approved dosing regimens underscores the need for a more
efficient process of dose selection in the early stages of study
design.

II. Summary

    FDA's Center for Drug Evaluation and Research and the AACR agree to
cosponsor a workshop focusing on providing a forum for discussion of
best practices on dose finding of small molecule oncology drugs. The
workshop will be held May 18 and 19, 2015, and is expected to include
between 10 to 13

panelists and speakers (including a moderator) per each of the 4
sessions and will be open to the public.

III. Purpose

    The purpose of this 2-day workshop is to provide an
interdisciplinary forum to discuss the best practices of dose finding
and dose selection for small molecule kinase inhibitors developed for
oncology indications. The goal is to foster robust scientific
discussion to promote a movement away from the conventional 3+3 dose
escalation trial design and move toward adaptive designs that can
potentially incorporate key clinical, pharmacologic, and pharmacometric
data and, when appropriate, nonclinical information to guide dose
selection. Ideally, this workshop will propel a movement toward
integrating dose finding into the entire life cycle of product
development as opposed to confining it to the Phase 1, first-in-human
trial based on short-term safety measures.

IV. Goals and Scope

    1. To identify key best practices in the nonclinical evaluation of
a compound, including, but not limited to, selectivity, pharmacology,
secondary pharmacology, and toxicology.
    2. To assess whether nonclinical information can be incorporated
into the statistical assumptions of an adaptive dose-finding trial.
    3. To discuss the best practices of integrating human
pharmacokinetic and pharmacometric data, including drug interaction,
when appropriate, into dose-finding studies.
    4. To assess how drug exposure can be integrated into the
statistical assumptions of an adaptive dose-finding trial and to assess
whether evolving exposure data can be adapted into an ongoing trial.
    5. To discuss barriers in moving away from 3+3 designs toward
adaptive designs and to encourage creative dose-finding trial designs
that can replace the conventional 3+3 dose-finding study, where
appropriate.
    6. To shift from conducting a large single-arm drug trial with the
maximum tolerated dose based on a 28-day window to identify tolerable,
biologically effective doses for confirmatory trials through prudent
search of doses based on safety, efficacy, and patient tolerability.
    7. To discuss potential regulatory implications of dose-finding
studies, including, but not limited to, product labeling of dose
ranges, dose titration, and postmarketing studies.

    Dated: May 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11536 Filed 5-12-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 98 (Monday, May 21, 2018)]
[Notices]
[Pages 23469-23470]
[FR Doc No: 2018-10685]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0361]

Mary C. Holloway; Order Revoking a Proposed Order of Debarment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is revoking a proposed
order, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), to
debar Mary C. Holloway (Holloway) for 5 years from providing services
in any capacity to a person that has an approved or pending drug
product application. Holloway, through counsel, filed a request for a
hearing, as well as information and analysis in support of that
request, in response to the proposed debarment order. FDA has
determined that pursuing debarment of Holloway is no longer
appropriate.

DATES: This order is applicable May 21, 2018.

FOR FURTHER INFORMATION CONTACT: Nathan Sabel, Office of Scientific
Integrity, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 1, Rm. 4206, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On April 8, 2009, Holloway, formerly a regional sales manager at
Pharmacia & Upjohn Company, Inc. (Pharmacia), pled guilty to a Federal
misdemeanor offense under sections 301(a), 303(a)(1), and 502(f) of the
FD&C Act (21 U.S.C. 331(a), 333(a)(1), and 352(f)). In June 2009, the
U. S. District Court for the District of Massachusetts entered the
conviction and sentenced Holloway to probation. The basis for the
conviction was Holloway's involvement in Pharmacia's introduction into
interstate commerce of its drug BEXTRA, a pain reliever and anti-
inflammatory, for the unapproved use of treating pre- and postoperative
surgical pain. Before it was removed from the market several years
later, BEXTRA was only approved for treatment of arthritis and primary
dysmenorrhea. In September 2009, Pharmacia pled guilty to a felony
violation of the FD&C Act for the promotion of BEXTRA and other drugs
for unapproved uses.
    By letter dated January 20, 2010, FDA's Office of Regulatory
Affairs (ORA) notified Holloway of a proposal to debar her for 5 years
from providing services in any capacity to a person having an approved
or pending drug product application. The proposal stated that Holloway
is subject to permissive debarment based on a finding, under section
306(b)(2)(B)(i) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(i)), that she
was convicted of a misdemeanor under Federal law for conduct relating
to the regulation of a drug product and that the type of conduct
serving as the basis for the conviction undermines the process for the
regulation of drugs. The proposal further concluded that Holloway
should be debarred for the maximum period of 5 years under section
306(c)(2)(A)(iii) of the FD&C Act based on four applicable
considerations in section 306(c)(3).
    In a letter dated February 18, 2010, through counsel, Holloway
requested a hearing on the proposal. On March 24, 2010, Holloway
submitted materials and arguments in support of her request. In her
submissions, Holloway acknowledged her conviction of a misdemeanor
under Federal law. Holloway conceded that she is subject to debarment
as a result of this conviction, but she argues nonetheless that she is
entitled to a hearing to determine whether permissive debarment is
appropriate. Specifically, Holloway argued that, with respect to the
considerations for determining the appropriateness and period of
debarment under section 306(c)(3) of the FD&C Act, there are genuine
and substantial issues of fact for resolution at a hearing.
    By letter dated April 3, 2013, the Office of the Commissioner, in
order to determine whether granting a hearing would be appropriate,
requested that ORA submit a response to Holloway's request for a
hearing. ORA was invited to include any documentary evidence,
information, or analysis that it deemed appropriate in support of its
response. Holloway was afforded an opportunity to submit evidence and
arguments in opposition. ORA submitted its response on August 30, 2013.
Holloway, through counsel, replied to ORA's response on November 15,
2013.
    Under Sec.  12.26 (21 CFR 12.26), if FDA determines upon review of
a request for hearing that the order at issue should be modified or
revoked, FDA may modify or revoke the order by notice in the Federal
Register. Based upon a review of the record, the Acting Chief Scientist
concludes that it is appropriate under Sec.  12.26, in this instance,
to revoke the proposed order to debar Holloway for 5 years.

II. Arguments

    In the proposal to debar Holloway for 5 years, ORA noted that there
are four applicable considerations for determining the appropriateness
and period of Holloway's debarment under section 306(c)(3) of the FD&C
Act: (1) The nature and seriousness of her offense under section
306(c)(3)(A); (2) the nature and extent of management participation in
the offense under section 306(c)(3)(B); (3) the nature and extent of
voluntary steps taken to mitigate the impact on the public under
section 306(c)(3)(C); and (4) prior convictions involving matters
within the jurisdiction of FDA under section 306(c)(3)(F). ORA found
that the first three of those considerations weigh in favor of
debarment and noted, as to the fourth consideration, that FDA is
unaware of any prior convictions. In finding that the each of the first
three considerations weighs in favor of debarment, ORA appears to have
characterized Holloway's conduct based on contested allegations from
Holloway's criminal proceedings.
    Holloway challenged both ORA's conclusions with respect to all
three considerations in dispute and the factual underpinnings of those
conclusions. Holloway contended that, under section 306(i) of the FD&C
Act, FDA may not take any action under sections 306(b) or section
306(c) with respect to any person ``unless [FDA] has issued an order
for such action made on the record after opportunity for an agency
hearing on disputed issues of material fact.'' Section 306(c)(3)
explicitly requires that FDA consider, ``where applicable,'' certain
factors ``[i]n determining the appropriateness and the period of
debarment'' for any permissive debarment.
    In proposing to debar Holloway for 5 years, ORA appears to have
based its findings with respect to certain considerations in section
306(c)(3) of the FD&C Act largely on the factual

allegations in the criminal information to which Holloway pled guilty
under her plea agreement. As Holloway argues, however, the records of
her criminal proceedings reflect that she did not admit to any of the
specific factual allegations in the information during the plea
colloquy conducted by the court. In fact, her attorney during the
criminal proceedings explicitly stated, ``[The information] contains
many allegations that Ms. Holloway disputes.'' After the prosecution
summarized the evidence that it planned to introduce at trial, which
closely mirrored the allegations in the information, the court accepted
Holloway's guilty plea on the basis of the following exchange:

    THE COURT: Okay. I gather that some of the facts are in dispute;
is that correct?
    THE DEFENDANT: Correct.
    THE COURT: Do you want to make a statement or, counsel, do you
want to make a statement?
* * * * *
    [DEFENSE COUNSEL]: Ms. Holloway is, she is prepared to admit
that she promoted BEXTRA for off label usage, and she understands
that that constitutes the introduction of BEXTRA into interstate
commerce with inadequate directions for use.
    THE COURT: All right. Ms. Holloway, do you agree, do you accept
your counsel's representation as to the facts that you accept to be
true?
    THE DEFENDANT: Yes, ma'am.

    In her request for a hearing and subsequent submissions (March 24,
2010, and November 15, 2013), Holloway argued that her lack of
admission to any specific facts during her criminal proceedings calls
into question ORA's findings with respect to certain considerations
under section 306(c)(3). In addition, with regard to certain ORA
allegations in the proposed order to debar Holloway (January 20, 2010),
and in support of facts weighing against debarment, Holloway has
presented particularized challenges supported by explanations or
documentary evidence.
    After a review of the record, the Acting Chief Scientist concludes
that, given the exceptional circumstances of this matter, it appears
that it would likely be necessary to grant the pending request for a
hearing. Such a hearing would require a broad scope to address any
genuine and substantial issues of fact that are material to weighing
the applicable considerations under section 306(c)(3) of the FD&C Act.
As a result of this extraordinary posture, the scope of the disputed
facts in this matter includes many of the facts that a prior criminal
proceeding would typically have established, as well as those
additional facts in dispute that relate to certain of the applicable
debarment considerations in section 306(c)(3) of the FD&C Act. Because
few factual findings relating to Holloway's specific conduct and
actions between December 2001 and April 2005 underlying her 2009
conviction were generated during the criminal proceedings, a hearing to
establish ORA's proposed findings would require a substantial devotion
of the Agency's limited resources to this individual debarment
proceeding.
    The Acting Chief Scientist has weighed the Agency's limited
resources against the factors that weigh in favor of proceeding to
evaluate ORA's proposed debarment order at an evidentiary hearing.
Chief among these countervailing considerations are the nature and
seriousness of the offense articulated by ORA and the Agency's interest
in effectuating the remedial purpose of the statute in furtherance of
the public health. The Acting Chief Scientist has accorded significant
weight to those countervailing considerations but, in reaching a
decision in this matter, has balanced those considerations against the
extraordinary resources necessary to conduct an evidentiary hearing on
the factual underpinnings for ORA's proposed findings as to the
considerations in section 306(c)(3) of the FD&C Act, when there were
few specific facts established as part of the criminal proceeding.
    After a careful evaluation of the arguments and information
provided by both ORA and Holloway as they relate to the nature and
breadth of the factual disputes at issue here, and after a
consideration of the resources necessary to proceed under this unusual
set of circumstances, the Acting Chief Scientist has determined that
the revocation of the proposed order to debar Holloway is appropriate
in this instance.

III. Order

    Upon review of the request for hearing, evidence, and arguments,
the Acting Chief Scientist revokes the January 20, 2010, proposed order
to debar Holloway and provides this notice of revocation in the Federal
Register as required by Sec.  12.26.

    Dated: May 14, 2018.
Denise Hinton,
Acting Chief Scientist.
[FR Doc. 2018-10685 Filed 5-18-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: January 25, 2007 (Volume 72, Number 16)]
[Notices]
[Page 3448-3450]
[DOCID:fr25ja07-84]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55139; File No. SR-BSE-2007-01]

Self-Regulatory Organizations; Boston Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Extend the Effective Date of a Previous Rule Change Relating to
Information Contained in a Directed Order on the Boston Options
Exchange

January 19, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on January 16, 2007, the Boston Stock Exchange, Inc. (``BSE'' or
``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 substantially prepared by the BSE. The
BSE filed the proposed rule change pursuant to Section 19(b)(3)(A) of
the Act \3\ and Rule 19b-4(f)(6) thereunder,\4\ which renders the
proposed rule change effective upon filing with the Commission. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The BSE proposes to extend the effective date of the amended rule
governing the Exchange's Directed Order process on the Boston Options
Exchange (``BOX'') from January 31, 2007 to July 31, 2007.

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

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

1. Purpose
    On March 20, 2006 the BSE proposed an amendment to its rules
governing its Directed Order process on the BOX.\5\ The rules were
amended to clearly state that the BOX Trading Host identifies to an
Executing Participant (``EP'') the identity of the firm entering a
Directed Order. The amended rule was to be effective until June 30,
2006, while the Commission considered a corresponding Exchange proposal
\6\ to amend its rules to permit EPs to choose the firms from which
they will accept Directed Orders, while providing complete anonymity of
the firm entering a Directed Order.
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    \5\ See Securities Exchange Act Release No. 53516 (March 20,
2006), 71 FR 15232 (March 27, 2006) (SR-BSE-2006-14).
    \6\ See Securities Exchange Act Release No. 53357 (February 23,
2006), 71 FR 10730 (March 2, 2006) (SR-BSE-2005-52).
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    On June 30, 2006, the Exchange proposed extending the effective
date of the amended rule governing its Directed Order process on the
BOX from June 30,

2006 to September 30, 2006 \7\ while the Commission continued to
consider the corresponding Exchange proposal to amend its rules to
permit EPs to choose the firms from which they would accept Directed
Orders, while providing complete anonymity of the firm entering a
Directed Order and, on September 11, 2006, the Exchange again proposed
extending the effective date of the amended rule governing its Directed
Order process on the BOX from September 30, 2006 to January 31,
2007.\8\
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    \7\ See Securities Exchange Act Release No. 54082 (June 30,
2006), 71 FR 38913 (July 10, 2006) (SR-BSE-2006-29).
    \8\ See Securities Exchange Act Release 54469 (September 19,
2006), 71 FR 56201 (September 26, 2006) (SR-BSE-2006-38).
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    The Exchange now proposes another extension of the effective date
of the amended rule governing its Directed Order process on the BOX
from January 31, 2007, to July 31, 2007. In the event the Commission
reaches a decision with respect to the corresponding Exchange proposal
to amend its rules before July 31, 2007, the amended rule governing the
Exchange's Directed Order process on the BOX will cease to be effective
at the time of that decision.
    This filing proposes to extend the effective date of the amended
rule governing the Exchange's Directed Order process on the BOX from
January 31, 2007 to July 31, 2007.\9\
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    \9\ In the event that the issue of anonymity in the Directed
Order process is not resolved by July 31, 2007, the Exchange intends
to submit another filing under Rule 19b-4(f)(6) under the Act
extending this rule and system process.
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2. Statutory Basis
    The amended rule is designed to clarify the information contained
in a Directed Order. This proposed rule filing seeks to extend the
amended rule's effectiveness from January 31, 2007 to July 31, 2007.
This extension will afford the Commission the necessary time to
consider SR-BSE-2005-52 which would amend the BOX rules on a permanent
basis to permit EPs to choose the firms from which they will accept
Directed Orders while providing complete anonymity of the firm entering
a Directed Order. Accordingly, the Exchange believes that the proposal
is consistent with the requirements of Section 6(b) of the Act,\10\ in
general, and Section 6(b)(5) of the Act,\11\ in particular, in that it
is designed to foster cooperation and coordination with persons engaged
in regulating, clearing, settling, processing information with respect
to, and facilitating transaction in securities, to remove impediments
to and perfect the mechanism for a free and open market and a national
market system, and, in general, to protect investors and the public
interest.
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    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
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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 Act.

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

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

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

    Because the foregoing proposed rule change: (1) Does not
significantly affect the protection of investors or the public
interest; (2) does not impose any significant burden on competition;
and (3) by its terms does not become operative for 30 days after the
date of this filing, or such shorter time as the Commission may
designate if consistent with the protection of investors and the public
interest, the proposed rule change has become effective pursuant to
Section 19(b)(3)(A) \12\ of the Act and Rule 19b-4(f)(6)
thereunder.\13\
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    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \14\ normally
may not become operative prior to 30 days after the date of filing.
However, Rule 19b-4(f)(6)(iii) \15\ permits the Commission to designate
a shorter time if such action is consistent with the protection of
investors and the public interest. The BSE requests that the Commission
waive the 5-day pre-filing notice requirement and the 30-day operative
delay, as specified in Rule 19b-4(f)(6)(iii),\16\ which would make the
rule change effective and operative upon filing. The Commission
believes that waiving the 5-day pre-filing notice and the 30-day
operative delay is consistent with the protection of investors and the
public interest because such waiver would continue to conform the BOX
rules with BOX's current practice and clarify that Directed Orders on
BOX are not anonymous.\17\ Accordingly, the Commission designates that
the proposed rule change effective and operative upon filing with the
Commission.
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    \14\ 17 CFR 240.19b-4(f)(6).
    \15\ 17 CFR 240.19b-4(f)(6)(iii).
    \16\ 17 CFR 240.19b-4(f)(6)(iii).
    \17\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

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

File No. SR-BSE-2007-01 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.
    All submissions should refer to File Number SR-BSE-2007-01. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the BSE.
    All comments received will be posted without change; the Commission
does

not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-BSE-2007-01 and should be
submitted on or before February 15, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-1103 Filed 1-24-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 127 (Tuesday, July 2, 2013)]
[Rules and Regulations]
[Pages 39606-39608]
[FR Doc No: 2013-15832]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2013-0540]
RIN 1625-AA00

Safety Zone; City of Menominee 4th of July Fireworks, Green Bay,
Menominee, MI

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
waters of Green Bay near Menominee, MI. This safety zone is intended to
restrict vessels from a portion of Green Bay due to a fireworks
display. This temporary safety zone is necessary to protect the
surrounding public and vessels from the hazards associated with the
fireworks display.

DATES: This rule is effective and will be enforced from 9 p.m. until
10:30 p.m. on July 4, 2013.

ADDRESSES: Documents mentioned in this preamble are part of docket
USCG-2013-0540. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, contact or email MST1 Joseph McCollum, U.S. Coast Guard
Sector Lake Michigan, at<PHONE_NUMBER> or<EMAIL_ADDRESS>If
you have questions on viewing the docket, call Barbara Hairston,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
TFR Temporary Final Rule

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing an notice NPRM with respect to this
rule because doing so would be impracticable and contrary to the public
interest. The final details for this event were not known to the Coast
Guard until there was insufficient time remaining before the event to
publish an NPRM. Thus, delaying the effective date of this rule to wait
for a comment period to run would be both impracticable and contrary to
the public interest because it would inhibit the Coast Guard's ability
to protect spectators and vessels from the hazards associated with a
maritime fireworks display, which are discussed further below.
    Under 5 U.S.C. 553(d)(3), The Coast Guard finds that good cause
exists for making this temporary rule effective less than 30 days after
publication in the Federal Register. For the same reasons discussed in
the preceding paragraph, waiting for a 30 day notice period to run
would be impracticable and contrary to the public interest.

B. Basis and Purpose

    The legal basis for the rule is the Coast Guard's authority to
establish regulated navigation areas and limited access areas: 33
U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33
CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-295, 116 Stat. 2064;
Department of Homeland Security Delegation No. 0170.1.
    The City of Menominee will sponsor a fireworks display on the
waters of Green Bay from the break wall of Menominee Memorial Marina
during the evening of July 4, 2013. The Coast Guard anticipates that a
large number of spectators will congregate around the launch position
during the display. The Captain of the Port, Lake Michigan, has
determined that the fireworks display will pose a significant risk to
public safety and property. Such hazards include falling debris,
flaming debris, and collisions among spectator vessels.

C. Discussion of the Final Rule

    With the aforementioned hazards in mind, the Captain of the Port,
Lake Michigan, has determined that this temporary safety zone is
necessary to ensure the safety of spectators and vessels during the
fireworks display

within Green Bay. This zone will be effective and enforced from 9 p.m.
until 10:30 p.m. on July 4, 2013. This zone will encompass all waters
of Green Bay near Menominee, MI within a 800-foot radius of an
approximate launch position at 45[deg]6'25.2'' N, 87[deg]36'4.8'' W
(NAD 83).
    Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port, Lake Michigan,
or his designated on-scene representative. The Captain of the Port or
his designated on-scene representative may be contacted via VHF Channel
16.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. It is not
``significant'' under the regulatory policies and procedures of the
Department of Homeland Security (DHS).
    We conclude that this rule is not a significant regulatory action
because we anticipate that it will have minimal impact on the economy,
will not interfere with other agencies, will not adversely alter the
budget of any grant or loan recipients, and will not raise any novel
legal or policy issues. The safety zone created by this rule will be
small and enforced for only one day in July. Under certain conditions,
moreover, vessels may still transit through the safety zone when
permitted by the Captain of the Port.

2. Impact on Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered the impact of this proposed rule on small entities. The
Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule
will not have a significant economic impact on a substantial number of
small entities. The Coast Guard certifies under 5 U.S.C. 605(b) that
this rule will not have a significant economic impact on a substantial
number of small entities. This rule will affect the following entities,
some of which might be small entities: The owners or operators of
vessels intending to transit or anchor in a portion of Green Bay on
July 4, 2013.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the reasons discussed in the
Regulatory Planning and Review section. Additionally, before
enforcement of the zone, we will issue a local Broadcast Notice to
Mariners so vessel owners and operators can plan accordingly.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

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

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

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

7. Unfunded Mandates Reform Act

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

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations

That Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves the establishment of a safety zone and,
therefore it is categorically excluded from further review under
paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An
environmental analysis checklist supporting this determination and a
Categorical Exclusion Determination are available in the docket where
indicated under ADDRESSES. We seek any comments or information that may
lead to the discovery of a significant environmental impact from this
rule.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  33 U.S.C. 1231; 46 U.S.C. Chapters 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T09-0540 to read as follows:

Sec.  165.T09-0540  Safety Zone; City of Menominee 4th of July
Fireworks, Green Bay, Menominee, MI.

    (a) Location. All waters of Green Bay near Menominee, MI within a
800-foot radius of an approximate launch position from the break wall
at Menominee Memorial Marina at 45[deg]6'25.2'' N, 87[deg]36'4.8'' W
(NAD 83).
    (b) Effective and Enforcement Period. This rule is effective and
will be enforced from 9 p.m. until 10:30 p.m. on July 4, 2013.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into, transiting, or anchoring within
this safety zone is prohibited unless authorized by the Captain of the
Port, Lake Michigan or his designated on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port, Lake Michigan or his
designated on-scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port,
Lake Michigan is any Coast Guard commissioned, warrant or petty officer
who has been designated by the Captain of the Port, Lake Michigan to
act on his behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zone shall contact the Captain of the Port, Lake Michigan or his on-
scene representative to obtain permission to do so. The Captain of the
Port, Lake Michigan or his on-scene representative may be contacted via
VHF Channel 16.
    Vessel operators given permission to enter or operate in the safety
zone must comply with all directions given to them by the Captain of
the Port, Lake Michigan, or his on-scene representative.

    Dated: June 21, 2013.
M.W. Sibley,
Captain, U.S. Coast Guard, Captain of the Port, Lake Michigan.
[FR Doc. 2013-15832 Filed 7-1-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 25 (Tuesday, February 9, 2021)]
[Notices]
[Pages 8773-8774]
[FR Doc No: 2021-02628]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP21-451-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 2.2.21 Negotiated Rates--
Mercuria Energy America, LLC H-7540-89 to be effective 2/2/2021.
    Filed Date: 2/2/21.
    Accession Number: 20210202-5019.
    Comments Due: 5 p.m. ET 2/16/21.

    Docket Numbers: RP21-452-000.
    Applicants: Rover Pipeline LLC.

    Description: Sec.  4(d) Rate Filing: Summary of Negotiated Rate
Capacity Release Agreements on 2-2-21 to be effective 2/1/2021.
    Filed Date: 2/2/21.
    Accession Number: 20210202-5039.
    Comments Due: 5 p.m. ET 2/16/21.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: February 3, 2021.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2021-02628 Filed 2-8-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 143 (Wednesday, July 25, 2018)]
[Notices]
[Page 35295]
[FR Doc No: 2018-15857]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Form N-8B-2, SEC File No. 270-186, OMB Control No. 3235-0186

    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
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    Form N-8B-2 (17 CFR 274.12) is the form used by unit investment
trusts (``UITs'') other than separate accounts that are currently
issuing securities, including UITs that are issuers of periodic payment
plan certificates and UITs of which a management investment company is
the sponsor or depositor, to comply with the filing and disclosure
requirements imposed by section 8(b) of the Investment Company Act of
1940 (15 U.S.C. 80a-8(b)). Form N-8B-2 requires disclosure about the
organization of a UIT, its securities, the personnel and affiliated
persons of the depositor, the distribution and redemption of
securities, the trustee or custodian, and financial statements. The
Commission uses the information provided in the collection of
information to determine compliance with section 8(b) of the Investment
Company Act.
    Each registrant subject to the Form N-8B-2 filing requirement files
Form N-8B-2 for its initial filing and does not file post-effective
amendments on Form N-8B-2.\1\ The Commission staff estimates that
approximately one respondent files one Form N-8B-2 filing annually with
the Commission.\2\ Staff estimates that the burden for compliance with
Form N-8B-2 is approximately 10 hours per filing. The total hour burden
for the Form N-8B-2 filing requirement therefore is 10 hours in the
aggregate (1 respondent x one filing per respondent x 10 hours per
filing).
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    \1\ Post-effective amendments are filed with the Commission on
the UIT's Form S-6. Hence, respondents only file Form N-8B-2 for
their initial registration statement and not for post-effective
amendments.
    \2\ In 2015 the Commission received 3 filings, while in 2016 and
2017, the Commission received 0 filings, respectively. The
cumulative 3-year average is, therefore, 1 filing per year.
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    Estimates of the burden hours are made solely for the purposes of
the PRA and are not derived from a comprehensive or even a
representative survey or study of the costs of SEC rules and forms. The
information provided on Form N-8B-2 is mandatory. The information
provided on Form N-8B-2 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 proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency'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 Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Candace
Kenner, 100 F Street NE, Washington, DC 20549; or send an email to:
[email protected].

    Dated: July 19, 2018.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-15857 Filed 7-24-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 221 (Thursday, November 15, 2018)]
[Notices]
[Pages 57476-57477]
[FR Doc No: 2018-24976]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9986-52-OAR]

Notice of Public Meeting of the Interagency Steering Committee on
Radiation Standards (ISCORS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public meeting.

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SUMMARY: The Environmental Protection Agency (EPA) will host a meeting
of the Interagency Steering Committee on Radiation Standards (ISCORS)
on Thursday, December 6, 2018 in Washington, DC. The purpose of ISCORS
is to foster early resolution and coordination of regulatory issues
associated with radiation standards. Member agencies include: EPA; the
Nuclear Regulatory Commission; and Departments of Energy; Defense;
Transportation; Homeland Security; Health and Human Services; and
Labor's Occupational Safety and Health Administration. Observer
agencies include: The Office of Science and Technology Policy, Office
of Management and Budget, Defense Nuclear Facilities Safety Board, as
well as state representatives from Pennsylvania and Washington. ISCORS
maintains several objectives: Facilitate a consensus on allowable
levels of radiation risk to the public and workers; promote consistent
and scientifically sound risk assessment and risk management approaches
in setting and implementing standards for occupational and public
protection from ionizing radiation; promote completeness and coherence
of Federal standards for radiation protection; and identify interagency
radiation protection issues and coordinate their resolution. ISCORS
meetings include presentations by Subcommittee Chairs and discussions
of current radiation protection issues. Committee meetings normally
involve pre-decisional intra-governmental discussions and, as such, are
normally not open for observation by members of the public or media.
This particular ISCORS meeting is open to all interested members of the
public. Time will be reserved on the agenda for members of the public
to ask questions and provide comments.
    Please Note: The final meeting agenda will be posted on the website
shortly before the meeting.

DATES: The meeting will be held on Thursday, December 6, 2018, from
1:00 p.m. to 4:30 p.m.

ADDRESSES: The ISCORS meeting will be held in Room 1153 at the USEPA
William Jefferson Clinton East Building (WJC East), 1201 Constitution
Avenue NW, Washington, DC. Attendees are required to present a photo ID
such as a government agency photo identification badge or valid
driver's license. The Department of Homeland Security has begun
implementing REAL ID Act requirements for visitors who present state-
issued driver's licenses as IDs at restricted federal facilities.
Driver's licenses from states and territories that do not comply with
the REAL ID Act will not be accepted as identification. More details on
these ID requirements can be found at http://www2.epa.gov/aboutepa/visiting-epa-headquarters and clicking on the Building Access tab.
Visitors and their belongings will be screened by EPA security guards.
Visitors must sign the visitors log at the security desk and will be
issued a visitors badge by the security guards to gain access to the
meeting.

FOR FURTHER INFORMATION CONTACT: Marisa D. Thornton, Radiation
Protection Division, Office of Radiation and Indoor Air, Mailcode
6608T, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue
NW, Washington, DC 20460; email [email protected].

SUPPLEMENTARY INFORMATION: Pay parking is available for visitors at
multiple garages around the Ronald Reagan building and Federal Triangle
complex. Visitors can also ride metro to the Federal Triangle station
(Blue Orange and Silver Line). After exiting the turnstiles, go up both
escalators to street level. Turn around and walk towards 12th Street
NW. Turn right on 12th street and continue walking until you get to
Constitution Avenue. Then turn right onto Constitution Avenue and 1201
William Jefferson Clinton EAST is the first building on your right.
    Visit the ISCORS website, www.iscors.org/index.htm for more
detailed information.

    Dated: November 6, 2018.
Jonathan D. Edwards,
Director, Office of Radiation and Indoor Air.
[FR Doc. 2018-24976 Filed 11-14-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: June 18, 2008 (Volume 73, Number 118)]
[Notices]
[Page 34828-34829]
[DOCID:fr18jn08-144]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2006-25756]

Commercial Driver's License (CDL) Standards; Volvo Trucks North
America, Inc.'s Exemption Application

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

ACTION: Notice of final disposition; granting of application for
exemption.

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SUMMARY: FMCSA announces its decision to grant Volvo Trucks North
America, Inc.'s (Volvo) application for an exemption for three of its
drivers to enable them to test-drive commercial motor vehicles (CMVs)
in the United States without a commercial driver's license (CDL) issued
by one of the States. Volvo had requested that the exemption cover
three Swedish engineers and technicians who will test drive CMVs for
Volvo within the U.S. They stated the exemption is needed to support a
Volvo field test to meet future air quality standards and to test-drive
Volvo prototype vehicles to verify results in ``real world''
environments. Each of these drivers holds a valid CDL issued in Sweden
but lacks the U.S. residency necessary to obtain a CDL issued by one of
the States in the U.S. FMCSA believes the knowledge and skills testing
and training program that drivers must undergo to obtain a Swedish CDL
ensures that these drivers will achieve a level of safety that is
equivalent to, or greater than, the level of safety achieved without
the exemption.

DATES: This decision is effective June 18, 2008. The exemption expires
on June 18, 2010.

FOR FURTHER INFORMATION CONTACT: Mr. Richard Clemente, Driver and
Carrier Operations Division, Office of Bus and Truck Standards and
Operations, MC-PSD, Federal Motor Carrier Safety Administration, 1200
New Jersey Avenue, SE., Washington, DC 20590. Telephone:<PHONE_NUMBER>.
E-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31315 and 31136(e), FMCSA may grant an exemption
from the CDL requirements in 49 CFR 383.23 for a 2-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to, or greater than, the level that would be achieved absent
such exemption'' (49 CFR 381.305(a)). FMCSA has evaluated Volvo's
application on its merits and decided to grant the exemption for three
of Volvo's engineers and technicians for a 2-year period.

Volvo Application for an Exemption

    Volvo applied for an exemption from the 49 CFR 383.23 requirement
that the operator of a CMV obtain a CDL. This section of the Federal
Motor Carrier Safety Regulations (FMCSRs) sets forth the standards that
States must employ in issuing CDLs to drivers operating in commerce. In
the U.S., an individual must be a resident of a State in order to
qualify for a CDL \1\. The Volvo drivers-employees for whom this
exemption is sought are all citizens and residents of Sweden;
therefore, they cannot apply for a CDL in any State of the United
States. A copy of the request for exemption from section 383.23 is in
the docket identified at the beginning of this notice.
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    \1\ Although 49 CFR 383.23 indicates that these drivers could
obtain a Nonresident CDL, few States are currently issuing
Nonresident CDLs.
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Swedish Drivers

    This exemption enables the following drivers to test-drive in the
U.S. Volvo CMVs that are assembled, sold or primarily used in the U.S.:
Andreas Hamsten, Carl-Gustaf Theen and Therese Johansson.
    Collectively, these drivers form a team of engineers and
technicians. Volvo currently employs these drivers in Sweden, and wants
them to be able to test-drive Volvo prototype vehicles at its test site
and in the vicinity of Phoenix, Arizona, to verify vehicle results in
``real world'' environments. These drivers would test-drive Volvo CMVs
that are assembled, sold or primarily used in the U.S. They are highly
trained,

experienced CMV operators with valid Swedish-issued CDLs. Because each
of the drivers was required to satisfy strict CDL testing standards in
Sweden to obtain a CDL and has extensive training and experience
operating CMVs, Volvo believes that the exemption will maintain a level
of safety equivalent to the level of safety that would be obtained
absent the exemption.

Method To Ensure an Equivalent or Greater Level of Safety

    According to Volvo, drivers applying for a Swedish-issued CDL must
undergo a training program and pass knowledge and skills tests. Volvo
believes the knowledge and skills tests and training program that these
drivers undergo to obtain a Swedish CDL ensure the exemption would
provide a level of safety that is equivalent to, or greater than, the
level of safety obtained by complying with the U.S. requirement for a
CDL. In addition, Volvo has submitted a copy of the Swedish driving
record of each of these drivers, and each has a driving record free of
violations.
    FMCSA had previously determined that the process for obtaining a
Swedish-issued CDL adequately assesses the driver's ability to operate
CMVs in the U.S. Therefore, the process for obtaining a Swedish-issued
CDL is considered to be comparable to, or as effective as, the
requirements of 49 CFR part 383.

Comments

    The Agency received one comment in response to its request for
public comments on the Volvo Notice of Application for Exemption
published in the Federal Register on March 14, 2008 (73 FR 13947). The
commentor objected to the granting of the exemption for the three
Swedish drivers, without stating any substantive reasons for the
objection.

FMCSA Decision

    FMCSA does not agree with the objection. The Agency decision to
grant these drivers an exemption from section 383.23 is based on the
merits of the application for exemption, and the rigorous knowledge and
skills testing of Swedish drivers concerning the safe operation of
CMVs.

Terms and Conditions for the Exemption

    Based upon evaluation of the application for an exemption, FMCSA
grants Volvo an exemption from the Federal CDL requirement in 49 CFR
383.23 for three drivers, identified under the ``Swedish Drivers''
heading above, to test-drive CMVs within the U.S., subject to the
following terms and conditions: (1) That these drivers will be subject
to drug and alcohol regulations, including testing, as provided in 49
CFR part 382, (2) that these drivers are subject to the same driver
disqualification rules under 49 CFR parts 383 and 391 that apply to
other CMV drivers in the U.S., (3) that these drivers keep a copy of
the exemption on the vehicle at all times, (4) that Volvo notify FMCSA
in writing of any accident, as defined in 49 CFR 390.5, involving one
of the exempted drivers, and (5) that Volvo notify FMCSA in writing if
any driver is convicted of a disqualifying offense described in section
383.51 or 391.15 of the FMCSRs.
    In accordance with 49 U.S.C. 31315 and 31136(e), the exemption will
be valid for 2 years unless revoked earlier by the FMCSA. The exemption
will be revoked if: (1) The drivers for Volvo fail 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. 31315 and 31136.

    Issued on: June 11, 2008.
 Larry W. Minor,
Associate Administrator for Policy and Program Development.
 [FR Doc. E8-13804 Filed 6-17-08; 8:45 am]

BILLING CODE 4910-EX-P