[Federal Register: June 14, 2007 (Volume 72, Number 114)]
[Notices]
[Page 32934-32935]
[DOCID:fr14jn07-101]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55879; File No. SR-NASD-2007-036]

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc.; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change Relating to a Technical Amendment to New NASD Rule 2342
(SIPC Information)

June 8, 2007
    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 June 1, 2007, the National Association of Securities Dealers, Inc.
(``NASD'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by NASD. NASD has
filed the proposal as a ``non-controversial'' rule change pursuant to
Section 19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(6) thereunder,\4\
which renders the proposal effective upon receipt of this filing by 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

    NASD is proposing to amend Rule 2342 (SIPC Information) to make a
technical amendment to clarify the categories of members that are
excepted from the scope of the rule. Below is the text of the proposed
rule change.\5\ Proposed new language is in italics; proposed deletions
are in brackets.
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    \5\ The underlying rule text used in this proposed rule change
is based on new NASD Rule 2342 which was approved by the SEC on May
10, 2007. See Securities Exchange Act Release No. 55737 (May 10,
2007), 72 FR 27606 (May 16, 2007) (Approval Order).
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* * * * *
2342. SIPC Information
    All members, except those members: (a) That pursuant to Section
3(a)(2)(A)(i) through (iii) of the Securities Investor Protection Act
of 1970 (SIPA) are excluded from membership in the Securities Investor
Protection Corporation (SIPC) and that are not SIPC members; [and] or
(b) whose business consists exclusively of the sale of investments that
are ineligible for SIPC protection, shall advise all new customers, in
writing, at the opening of an account, that they may obtain information
about SIPC, including the SIPC brochure, by contacting SIPC, and also
shall provide the Web site address and telephone number of SIPC. In
addition, such members shall provide all customers with the same
information, in writing, at least once each year. In cases where both
an introducing firm and clearing firm service an account, the firms may
assign these requirements to one of the firms.
* * * * *

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

    In its filing with the Commission, NASD 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. NASD 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 May 10, 2006, the Commission approved new Rule 2342 (SIPC
Information) to require NASD members, except those members (a) that
pursuant to Section 3(a)(2)(A)(i) through (iii) of the Securities
Investor Protection Act of 1970 (``SIPA'') are excluded from membership
in the Securities Investor Protection Corporation (``SIPC'') and that
are not SIPC members; or (b) whose business consists exclusively of the
sale of investments that are ineligible for SIPC protection, to provide
new customers, and all customers annually, with certain information
about SIPC.\6\ As approved, however, the rule text could be mistakenly
read to except only those members that are excluded from membership in
SIPC and are not SIPC members, and also have a business consisting
exclusively of investment products that are ineligible for SIPC
protection. Accordingly, NASD is filing this proposed rule change to
delete the ``and'' between paragraphs (a) and (b) of new Rule 2342 and
replace it with an ``or'' to clarify that the rule excepts from its
requirements a member that meets the conditions in either paragraphs
(a) or (b).
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    \6\ See supra note 5.
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    NASD has filed the proposed rule change for immediate
effectiveness. The effective date of new Rule 2342, as amended by this
proposed rule change, is November 6, 2007.
2. Statutory Basis
    NASD believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\7\ which requires, among
other things, that NASD rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. NASD believes that the proposed rule change is
consistent with the protection of investors and the public interest in
that it will avoid any confusion when reading the provisions of Rule
2342.
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    \7\ 15 U.S.C. 78o-3(b)(6).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    NASD does not believe that the proposed rule change will result in
any

burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.\8\
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    \8\ 15 U.S.C. 78a.
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

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

    Because the foregoing 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) \9\ of the Act and Rule 19b-
4(f)(6) thereunder.\10\
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    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

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

File Number SR-NASD-2007-036 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASD-2007-036. 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 NASD.
    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 the File Number SR-NASD-2007-
036 and should be submitted on or before July 5, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-11441 Filed 6-13-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 80, Number 102 (Thursday, May 28, 2015)]
[Rules and Regulations]
[Pages 30364-30367]
[FR Doc No: 2015-12775]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2009-0041-N-4]

49 CFR Part 234

RIN 2130-AC50

Systems for Telephonic Notification of Unsafe Conditions at
Highway-Rail and Pathway Grade Crossings

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: The purpose of this document is to update the current schedule
of civil penalties for violations of FRA's grade crossing safety
regulations by adding recommended civil penalty amounts for violations
of specific requirements contained in a recently added subpart. That
subpart prescribes requirements that certain railroads establish
emergency notification systems (ENS) for receiving toll-free telephone
calls reporting various unsafe conditions at highway-rail grade
crossings and pathway grade crossings, and for taking certain actions
in response to those calls.

DATES: Effective May 28, 2015.

FOR FURTHER INFORMATION CONTACT: Beth Crawford, Transportation
Specialist, Grade Crossing Safety and Trespass Prevention, Office of
Safety Analysis, FRA, 1200 New Jersey Avenue SE., Mail Stop 25,
Washington, DC 20590 (telephone:<PHONE_NUMBER><EMAIL_ADDRESS>
or Sara Mahmoud-Davis, Trial Attorney, Office of Chief Counsel, FRA,
1200 New Jersey Avenue SE., Mail Stop 10, Washington, DC 20590
(telephone:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FRA is revising the penalty schedule at
appendix A to 49 CFR part 234 to add recommended civil penalty amounts
for violations of specific requirements contained in subpart E,
Emergency Notification Systems [ENS] for Telephonic Reporting of Unsafe
Conditions at Highway-Rail and Pathway Grade Crossings. (See FRA's
final rule published on June 12, 2012, 77 FR 35164; March 15, 2013, 78
FR 16414.) The recommended civil penalties are for violations related
to the various requirements of an ENS, which includes the: (1) Sign(s)
placed at the grade crossing that display the information necessary for
the public to report an unsafe condition to the appropriate railroad;
(2) method the railroad uses to receive and process a telephone call
reporting the unsafe condition; (3) remedial action the appropriate
railroad or railroads take to address the report of the unsafe
conditions; and (4) recordkeeping conducted by the railroad(s).
    Under authority delegated from the Secretary of Transportation, FRA
adds these recommended penalty amounts to the penalty schedule
consistent with the requirements of 49 U.S.C. 21301(a)(2), which
provides, in pertinent part, that:

[t]he Secretary of Transportation shall include in, or make
applicable to, each regulation prescribed . . . under chapter 201 of
this title a civil penalty for a violation. * * * The amount of the
penalty shall be at least $500 but not more than $25,000. However,
when a grossly negligent violation or a pattern of repeated
violations has caused an imminent hazard of death or injury to
individuals, or has caused death or injury, the amount may be not
more than $100,000.

See delegation from the Secretary to the Administrator of FRA at 49 CFR
1.89(a).
    Under the separate authority of the Federal Civil Penalties
Inflation Adjustment Act of 1990 as amended, FRA has periodically
adjusted for inflation the amounts of the minimum, ordinary maximum,
and aggravated maximum civil penalties for a violation of this part.
Public Law 101-410, 104 Stat. 890, 28 U.S.C. 2461, note, as amended by
Section 31001(s)(1) of the Debt Collection Improvement Act of 1996,
Public Law 104-134, 110 Stat. 1321-373, April 26, 1996. Currently, the
minimum penalty is $650, the ordinary maximum civil penalty is $25,000;
and the aggravated maximum civil penalty is $105,000. See, e.g., 73 FR
76704, Dec. 30, 2008; 77 FR 24422, Apr. 24, 2012. As provided for in
footnote 1 to appendix A, the Administrator specifically reserves the
authority to assess the maximum penalty of $105,000 for any specific
violation if the circumstances of the particular violation warrant.
    After FRA issues a civil penalty against an entity, FRA may adjust
or compromise the amount of the civil penalty based on a wide variety
of mitigating factors, which include: (1) The nature, circumstances,
extent, and gravity of the violation; (2) with respect to the entity,
the degree of culpability, any history of violations, the ability to
pay, and any effect on the ability to continue to do business; and (3)
other matters that justice requires. 49 U.S.C. 21301(a)(3).
    FRA's revision of appendix A is a general statement of policy under
5 U.S.C. 553(b)(3)(A). Consequently, notice and an opportunity for
comment are not required, and this amendment is made effective upon
publication.

List of Subjects in 49 CFR Part 234

    Highway safety, Penalties, Railroad safety, Reporting and
recordkeeping requirements, State and local governments.

    In consideration of the foregoing, FRA amends part 234 of chapter
II, subtitle B of title 49, Code of Federal Regulations as follows:

PART 234--GRADE CROSSING SAFETY

0
1. The authority citation for part 234 continues to read as follows:

    Authority: 49 U.S.C. 20103, 20107, 20152, 20160, 21301, 21304,
21311, 22501 note; Pub. L. 110-432, Div. A., Sec. 202; 28 U.S.C.
2461, note; and 49 CFR 1.89.

0
2. Amend appendix A to part 234 by:
0
a. Adding, after the end of the entry for subpart D, an entry for
subpart E;
0
b. Revising footnote 1; and
0
c. Adding footnotes 2, 3, 4, 5, 6, and 7, to read as follows:

         Appendix A to Part 234--Schedule of Civil Penalties \1\
------------------------------------------------------------------------
                                                              Willful
                 Section                     Violation       violation
------------------------------------------------------------------------

                              * * * * * * *
Subpart E--Emergency Notification
 Systems for Telephonic Reporting of
 Unsafe Conditions at Highway-Rail and
 Pathway Grade Crossings
 234.303 Emergency notification systems
 (ENS) for telephonic reporting of
 unsafe conditions at highway-rail and
 pathway grade crossings:
    (a) Dispatching railroad fails to             15,000          25,000
     establish and maintain a toll-free
     telephone service by which the
     railroad can directly and promptly
     receive telephone calls (calls)
     from the public of reports of
     unsafe conditions at crossings.....
    (a)(1) Dispatching railroad fails to          10,000          15,000
     have either a live person answer
     calls directly and promptly, or use
     an automated answering system or
     third-party telephone service for
     receiving calls from the public of
     reports of unsafe conditions at
     crossings..........................
    (a)(2) Dispatching railroad                   10,000          15,000
     improperly uses an automated
     answering system...................
    (b)(1)-(2) Excepted dispatching                5,000           7,500
     railroad improperly uses answering
     machine to receive calls of unsafe
     conditions at crossings............
    (b)(2) Excepted dispatching railroad           5,000           7,500
     fails to use proper method to
     receive calls of unsafe conditions
     at crossings during either
     operational or non-operational
     hours..............................
    (e) Dispatching railroad improperly            5,000           7,500
     uses local telephone number to
     receive calls of unsafe conditions
     at crossings.......................
 234.305 Remedial actions in response to
 reports of unsafe conditions at highway-
 rail and pathway grade crossings:
Response to credible report of warning
 system malfunction at a highway-rail
 grade crossing.
    (a)(1) Maintaining railroad fails              5,000           7,500
     under subpart C to follow subpart C
     of this part \2\...................
    (a)(2)(i) Dispatching railroad fails           5,000           7,500
     to promptly contact all trains
     authorized to operate through the
     crossing and inform them of the
     reported malfunction...............
    (ii) Dispatching railroad fails to             5,000           7,500
     promptly contact the maintaining
     railroad and inform it of the
     reported malfunction...............
Response to public report of warning
 system malfunction at a highway-rail
 grade crossing.
    (b)(1)(i) Railroad with both                   5,000           7,500
     maintaining and dispatching
     responsibilities fails to promptly
     contact all trains authorized to
     operate through the crossing and
     inform them of the reported
     malfunction........................
    (ii) Railroad with both maintaining            5,000           7,500
     and dispatching responsibilities
     fails to promptly contact the
     appropriate law enforcement agency
     and inform it of the reported
     malfunction........................
    (iii) Railroad with both maintaining           5,000           7,500
     and dispatching responsibilities
     fails to promptly investigate the
     report, determine the nature of the
     malfunction, and take the
     appropriate remedial action........
    (b)(2)(i) Railroad with only                   5,000           7,500
     dispatching responsibility fails to
     promptly contact all trains
     authorized to operate through the
     crossing and inform them of the
     reported malfunction...............
    (ii) Railroad with only dispatching            5,000           7,500
     responsibility fails to promptly
     contact the appropriate law
     enforcement agency and inform it of
     the reported malfunction...........
    (iii) Railroad with only dispatching           5,000           7,500
     responsibility fails to promptly
     contact the maintaining railroad
     and inform it of the reported
     malfunction........................
    (iv) Maintaining railroad fails to             5,000           7,500
     promptly investigate the report,
     determine the nature of the
     malfunction, and take the
     appropriate remedial action........
Response to report of warning system
 failure at a pathway grade crossing.
    (c)(1)(i) Railroad with both                   5,000           7,500
     maintaining and dispatching
     responsibilities fails to promptly
     contact all trains authorized to
     operate through the crossing and
     inform them of the reported failure
    (ii) Railroad with both maintaining            5,000           7,500
     and dispatching responsibilities
     fails to promptly contact the
     appropriate law enforcement agency
     and inform it of the reported
     failure............................
    (iii) Railroad with both maintaining           5,000           7,500
     and dispatching responsibilities
     fails to promptly investigate the
     report, determine the nature of the
     failure, and without undue delay
     repair the active warning system if
     necessary..........................
(c)(2)(i) Railroad with only dispatching           5,000           7,500
 responsibility fails to promptly
 contact all trains authorized to
 operate through the crossing and inform
 them of the reported failure...........
    (ii) Railroad with only dispatching            5,000           7,500
     responsibility fails to promptly
     contact the appropriate law
     enforcement agency and inform it of
     the reported failure...............
    (iii) Railroad with only dispatching           5,000           7,500
     responsibility fails to promptly
     contact the maintaining railroad
     and inform it of the reported
     failure............................
    (iv) Maintaining railroad fails to             5,000           7,500
     promptly investigate the report,
     determine the nature of the
     failure, and without undue delay
     repair the active warning system if
     necessary..........................
Response to report of a disabled vehicle
 or other obstruction blocking a
 railroad track at a highway-rail or
 pathway grade crossing.
    (d)(1)(i) Railroad with both                   5,000           7,500
     maintaining and dispatching
     responsibilities fails to promptly
     contact all trains authorized to
     operate through the crossing and
     inform them of the reported
     obstruction........................
    (ii) Railroad with both maintaining            5,000           7,500
     and dispatching responsibilities
     fails to promptly contact the
     appropriate law enforcement agency
     and inform it of the reported
     obstruction........................
    (iii) Railroad with both maintaining           5,000           7,500
     and dispatching responsibilities
     fails to promptly investigate the
     report, determine the nature of the
     obstruction, and without undue
     delay take the necessary action to
     have the obstruction removed.......
    (d)(2)(i) Railroad with only                   5,000           7,500
     dispatching responsibility fails to
     promptly contact all trains
     authorized to operate through the
     crossing and inform them of the
     reported obstruction...............
    (ii) Railroad with only dispatching            5,000           7,500
     responsibility fails to promptly
     contact the appropriate law
     enforcement agency and inform it of
     the reported obstruction...........

    (iii) Railroad with only dispatching           5,000           7,500
     responsibility fails to promptly
     contact the maintaining railroad
     and inform it of the reported
     obstruction........................
    (iv) Maintaining railroad fails to             5,000           7,500
     promptly investigate the report,
     determine the nature of the
     obstruction, and without undue
     delay take the necessary action to
     have the obstruction removed.......
Special rule on contacting a train that
 is not required to have communication
 equipment.
    (e) Having received a report                   5,000           7,500
     pursuant to Sec.   234.303(c)(1),
     (c)(2), (d)(1), or (d)(2), railroad
     fails to promptly contact the
     occupied controlling locomotive of
     the train by the quickest means
     available consistent with Sec.
     220.13(a) of this chapter..........
Response to report of an obstruction of
 view at a highway-rail or pathway grade
 crossing.
    (f)(1) Railroad with both                      5,000           7,500
     maintaining and dispatching
     responsibilities fails to timely
     investigate the report and remove
     the obstruction if it is lawful and
     feasible to do so..................
    (f)(2)(i) Railroad with only                   5,000           7,500
     dispatching responsibility fails to
     promptly contact the maintaining
     railroad...........................
    (ii) Maintaining railroad fails to             5,000           7,500
     timely investigate the report and
     remove the obstruction if it is
     lawful and feasible to do so.......
Response to report of other unsafe
 condition at a highway-rail or pathway
 grade crossing.
    (g)(1) Railroad with both                      5,000           7,500
     maintaining and dispatching
     responsibilities fails to timely
     investigate the report, and timely
     correct the unsafe condition if it
     is lawful and feasible to do so....
    (g)(2) Railroad with only                      5,000           7,500
     dispatching responsibility fails to
     promptly contact the maintaining
     railroad...........................
    (g)(3) Maintaining railroad fails to           5,000           7,500
     timely investigate the report, and
     timely correct the unsafe condition
     if it is lawful and feasible to do
     so.................................
Maintaining railroad's responsibilities
 for receiving reports of unsafe
 conditions at highway-rail and pathway
 grade crossings.
    (h)(1)(i) Maintaining railroad fails           5,000           7,500
     to provide sufficient contact
     information to dispatching
     railroad, by which the dispatching
     railroad may timely contact the
     maintaining railroad upon receipt
     of a report........................
    (ii) Maintaining railroad fails               10,000          15,000
     either to have a live person answer
     calls directly and promptly, or to
     use an automated answering system
     for receiving calls from the
     dispatching railroad of a report of
     an unsafe condition................
    (iii) Dispatching railroad                    10,000          15,000
     improperly uses an automated
     answering system...................
    (h)(2)(i)-(ii) Excepted maintaining            5,000           7,500
     railroad fails to use proper method
     to receive calls of unsafe
     conditions at crossings during
     operational or non-operational
     hours..............................
 234.306 Multiple dispatching or
 maintaining railroads with respect to
 the same highway-rail or pathway grade
 crossing; appointment of responsible
 railroad:
    (a)(1) Each of the dispatching                10,000          15,000
     railroads for the crossing fails to
     appoint a primary dispatching
     railroad for the crossing..........
    (a)(1)(i)-(iv) The primary                     5,000           7,500
     dispatching railroad for the
     crossing fails to carry out one of
     the prescribed duties..............
    (a)(2) Another pertinent dispatching           5,000           7,500
     railroad for the crossing fails to
     carry out remedial action as
     required by Sec.   234.305.........
    (b)(1) Each of the maintaining                 5,000           7,500
     railroads for the crossing fails to
     appoint one maintaining railroad
     responsible for the placement and
     maintenance of the ENS sign(s).....
    (b)(2) The assigned maintaining                5,000           7,500
     railroad in Sec.   234.306(b)(1)
     fails to display on the ENS sign(s)
     the emergency telephone number of
     the dispatching railroad or primary
     dispatching railroad for the
     crossing...........................
    (c)(1) The dispatching railroad or             5,000           7,500
     primary dispatching railroad fails
     to promptly contact and inform the
     appropriate maintaining railroad(s)
     for the crossing of the reported
     problem............................
    (c)(2) The maintaining railroad               10,000          15,000
     fails to carry out remedial action
     as required by Sec.   234.305......
 234.307 Use of third-party telephone
 service by dispatching and maintaining
 railroads \3\:
    (a)(1) Dispatching railroad                   10,000          15,000
     improperly uses third-party
     telephone service..................
    (a)(2) Dispatching railroad fails to          10,000          15,000
     ensure third-party telephone
     service compliance with Sec.
     234.307............................
    (b)(1) Maintaining railroad                   10,000          15,000
     improperly uses third-party
     telephone service..................
    (b)(2) Maintaining railroad fails to          10,000          15,000
     ensure third-party telephone
     service compliance with Sec.
     234.307............................
    (d)(1) Railroad fails to provide               2,500           5,000
     sufficient contact information to
     third-party telephone service......
    (d)(2)(i) Railroad fails to inform             2,500           5,000
     FRA in writing before the
     implementation of a third-party
     telephone service..................
    (ii) Railroad fails to provide FRA             2,500           5,000
     with contact information for the
     third-party telephone service......
    (iii) Railroad fails to provide FRA            2,500           5,000
     with information identifying the
     crossings about which the third-
     party telephone service will
     receive reports....................
    (d)(3) Railroad fails to inform FRA            2,500           5,000
     in writing within 30 days following
     any changes in the use of, or the
     discontinuance of, third-party
     telephone service..................
    (d)(4) \4\ Dispatching or
     maintaining railroad fails to take
     appropriate action required by Sec.
       234.305.
    (e) \5\ Railroad fails to ensure
     third-party telephone service
     compliance with Sec.   234.313 or
     Sec.   234.315, as applicable.
 234.309 ENS signs in general:
    (a) Dispatching railroad fails to              2,500           5,000
     provide ENS telephone number to the
     maintaining railroad a minimum of
     180 days prior to the required
     implementation date of the ENS.....
    (b)(1)-(3) \6\ Responsible railroad            5,000           7,500
     fails to display minimum required
     information on ENS sign............
    (c)(1)-(4) \7\ Responsible railroad            5,000           7,500
     fails to display ENS sign that
     meets size and other physical
     requirements.......................
 234.311 ENS sign placement and
 maintenance:
    (a)(1)-(2) Responsible railroad                5,000           7,500
     fails to place and maintain
     required number of sign(s) at the
     crossing or entrance(s) to facility
    (b)(1)-(2) Responsible railroad                5,000           7,500
     fails to properly locate and
     maintain the sign(s) at the
     crossing...........................
 234.313 Recordkeeping:

    (a)(1)-(9) Railroad fails to                   2,500           5,000
     maintain in its records the minimum
     information required for each ENS
     report received....................
    (c)(1)-(2) Responsible railroad(s)             2,500           5,000
     fail(s) to record in writing an
     appointment of a railroad, pursuant
     to Sec.   234.306, or properly
     retain a copy of the document......
    (d)(1) Railroad fails to properly              2,500           5,000
     retain records.....................
    (d)(2) Railroad fails to provide FRA           2,500           5,000
     access to records..................
 234.315 Electronic recordkeeping:
    (a)-(b) Railroad fails to comply               2,500           5,000
     with electronic recordkeeping
     requirements.......................
------------------------------------------------------------------------
\1\ A penalty may be assessed against an individual only for a willful
  violation. The Administrator reserves the right to assess a penalty of
  up to $105,000 for any violation where circumstances warrant. See 49
  CFR part 209, appendix A. To facilitate the assessment of penalty
  amounts, the specific types of violations of a given section are
  sometimes designated by the paragraph of the section (e.g., ``(a)'')
  and a code not corresponding to the legal citation for the violation
  (e.g., ``(1)''), so that the complete citation in the penalty schedule
  is e.g., ``(a)(1).'' FRA reserves the right to revise the citation of
  the violation in the Summary of Alleged Violations issued by FRA in
  the event of litigation.
\2\ Either this section or the parallel section of subpart C of this
  part may be cited, but not both.
\3\ FRA does not plan to assess civil penalties against a third-party
  telephone service, under Sec.   234.307(c) or (e). However, FRA plans
  to assess violations against the dispatching and maintaining railroads
  for failing to ensure that the third-party telephone service complies
  with the requirements of Sec.  Sec.   234.307, 234.313, or 234.315, if
  applicable. See Sec.   234.307(a), (b), (e).
\4\ For a violation of Sec.   234.307(d)(4), a penalty should be
  assessed for the specific type of violation according to the penalty
  schedule for a violation of Sec.   234.305.
\5\ For a violation of Sec.   234.307(e) pertaining to recordkeeping, a
  penalty should be assessed for the specific type of violation in the
  penalty schedule for a violation of Sec.  Sec.   234.313 or 234.315,
  as applicable.
\6\ FRA reserves the right to cite a violation for each item of required
  information omitted from a sign.
\7\ FRA reserves the right to cite a violation for each physical
  characteristic that is nonconforming.

    Issued in Washington, DC, on May 21, 2015.
Sarah Feinberg,
Acting Administrator.
[FR Doc. 2015-12775 Filed 5-27-15; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register Volume 79, Number 175 (Wednesday, September 10, 2014)]
[Notices]
[Pages 53808-53811]
[FR Doc No: 2014-21521]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72988; File No. SR-MIAX-2014-46]

Self-Regulatory Organizations; Miami International Securities
Exchange LLC; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend Its Fee Schedule

September 4, 2014.
    Pursuant to the provisions of Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on August 25, 2014, Miami International Securities
Exchange LLC (``MIAX'' or ``Exchange'') filed with the Securities and
Exchange Commission (``Commission'') a proposed rule change as
described in Items I, II, and III below, which Items have been prepared
by the Exchange. The Commission is publishing this notice to solicit
comments on the proposed rule 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 is filing a proposal to amend its Fee Schedule.
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.miaxoptions.com/filter/wotitle/
rulefiling, at MIAX's principal office, 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 Exchange 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 Exchange 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend its Fee Schedule to: (i) Amend the
MIAX Market Maker sliding scale to change the volume threshold
calculations from aggregate numbers to percentages of total national
Market Maker volume; (ii) increase the transaction fees for MIAX Market
Makers, Public Customers that are not a Priority Customer, Non-MIAX
Market Makers, Non-Member Broker-Dealers, and Firms by $0.02 per
contract; and (iii) provide for additional incentives for achieving
certain Priority Customer Rebate Program volume tiers. The proposed
changes are based on the similar fees of another competing options
exchange.\3\
---------------------------------------------------------------------------

    \3\ See NASDAQ OMX PHLX LLC Pricing Schedule, Section II. See
also Securities Exchange Act Release Nos. 71716 (March 13, 2014), 79
FR 71716 (March 19, 2014) (SR-PHLX-2014-14); 72395 (June 16, 2014),
79 FR 35391 (SR-PHLX-2014-38).
---------------------------------------------------------------------------

Volume Tiers
    The Exchange proposes to amend the MIAX Market Maker sliding scale
to change the volume threshold calculations from aggregate numbers to
percentages of total national Market Maker volume of any options
classes with traded volume on MIAX during the calendar month. The
Exchange notes that the sliding fee scale for MIAX Market Makers
structured on contract volume thresholds is based on the substantially
similar fees of the CBOE.\4\ By amending the volume tier calculations,
the sliding scale will more closely align with that of CBOE, which also
currently uses a substantially similar volume threshold calculation
based on percentages of total national Market Maker volume of any
options classes that trade on the exchange during the calendar month.
The Market Maker sliding scale will continue to apply to MIAX Market
Maker (RMM, LMM, DLMM, PLMM, DPLMM) transaction fees in all products
except mini-options. MIAX Market Makers will continue to be assessed a
$0.02 per executed contract fee for transactions in mini-options.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release Nos. 55193 (January 30,
2007), 72 FR 5476 (February 6, 2007) (SR-CBOE-2006-111); 58321
(August 6, 2008), 73 FR 46955 (SR-CBOE-2008-78); 71295 (January 14,
2014), 79 FR 3443 (January 21, 2014) (SR-CBOE-2013-129).
---------------------------------------------------------------------------

    The Exchange believes the proposed sliding scale is objective in
that the fee reductions are based solely on reaching stated volume
thresholds. The specific volume thresholds of the tiers were set based
upon business determinations and an analysis of current volume levels.
The specific volume thresholds and rates were set in order to encourage
MIAX Market Makers to reach for higher tiers. The Exchange believes
that the proposed changes to the tiered fee schedule may incent firms
to display their orders on the Exchange and increase the volume of
contracts traded here.
Options Transaction Fees
    The Exchange proposes to increase the transaction fees for MIAX
Market Makers, Public Customers that are not a Priority Customer, Non-
MIAX Market Makers, Non-Member Broker-Dealers, and Firms by $0.02 per
contract. Specifically, the Exchange proposes to increase transaction
fees for each of the volume tiers for MIAX Market Makers by $0.02. The
Exchange will also increase the transaction fees for Public Customers
that are not a Priority Customer and Firms from $0.25 to $0.27 per
contract. Further, the Exchange will increase the transaction fees for
Non-MIAX Market Makers and Non-Member Broker-Dealers from $0.45 to
$0.47. The Exchange believes that these fee increases will permit the
Exchange to incentivize market participants by offering other
incentives to lower prices as described herein.
Priority Customer Rebate Incentives
    The Exchange proposes to offer MIAX Market Makers, Public Customers
that are not a Priority Customer, Non-MIAX Market Makers, Non-Member
Broker-Dealers, and Firms the opportunity to reduce transaction fees by
$0.02 per contract in standard options if the Member or its affiliates
of at least 75% common ownership between the firms as reflected on each
firm's Form BD, Schedule A, qualifies in a given month for Priority
Customer Rebate Program volume tiers 3, 4, or 5 in the Fee Schedule.\5\
Specifically, any Member or its affiliates of at least 75% common
ownership between the firms as reflected on each firm's Form BD,
Schedule A, that qualifies for Priority Customer Rebate Program volume
tiers 3, 4, or 5 and is a MIAX Market Maker will be assessed $0.15 per
contract for tier 1, $0.10 per contract for tier 2, $0.05 per contract
for tier 3, and $0.03 per contract for tier 4 for transactions in
standard options in lieu of the applicable transaction fees in the
Market Maker sliding scale. In addition, any Member or its affiliates
of at least 75% common ownership between the firms as reflected on each
firm's Form BD, Schedule A, that qualifies for Priority Customer Rebate
Program volume tiers 3, 4, or 5 and is a Public Customers that are not
a Priority Customer or Firm will be assessed $0.25 per contract for
standard options. Further, any Member or its affiliates of at least 75%
common ownership between the firms as reflected on each firm's Form BD,
Schedule A, that qualifies for Priority Customer Rebate Program volume
tiers 3, 4, or 5 and is a Non-MIAX Market Makers or Non-Member Broker-
Dealers will be assessed $0.45 per contract for standard options.
---------------------------------------------------------------------------

    \5\ See MIAX Options Fee Schedule, Section 1)a)iii).
---------------------------------------------------------------------------

    The Exchange believes that these incentives will encourage MIAX
Market Makers, Public Customers that are not a Priority Customer, Non-
MIAX Market Makers, Non-Member Broker-Dealers, and Firms to transact a
greater number of orders on the Exchange.
    The Exchange proposes to implement the new transaction fees
beginning September 1, 2014.
2. Statutory Basis
    The Exchange believes that its proposal to amend its fee schedule
is consistent with Section 6(b) of the Act \6\ in general, and furthers
the objectives of Section 6(b)(4) of the Act \7\ in particular, in that
it is an equitable allocation of reasonable fees and other charges
among Exchange members.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The proposed changes to the volume calculations for the sliding
scale are reasonable, equitable, and not unfairly discriminatory. The
proposed volume discount fee structure is not discriminatory in that
all MIAX Market Makers are eligible to submit (or not submit)
liquidity, and may do so at their discretion in the daily volumes they
choose during the course of the billing period. All similarly situated
MIAX Market Makers are subject to the same fee structure, and access to
the Exchange is offered on terms that are not unfairly discriminatory.
Volume based discounts have been widely adopted by options and equities
markets, and are equitable because they are open to all MIAX Market
Makers on an equal basis and provide discounts that are reasonably
related to the value of an exchange's market quality associated with
higher volumes. The

proposed fee levels and volume thresholds are reasonably designed to be
comparable to those of other options exchanges employing similar fee
programs, and also to attract additional liquidity and order flow to
the Exchange.
    The Exchange's proposal to increase the transaction fees for MIAX
Market Makers, Public Customers that are not a Priority Customer, Non-
MIAX Market Makers, Non-Member Broker-Dealers, and Firms is reasonable
because the Exchange's fees will remain competitive with fees at other
options exchanges.\8\ The Exchange's proposal to increase the
transaction fees for MIAX Market Makers, Public Customers that are not
a Priority Customer, Non-MIAX Market Makers, Non-Member Broker-Dealers,
and Firms is equitable and not unfairly discriminatory because the
increase applies equally to all such market participants. The Exchange
does not assess Priority Customers transactions fees because Priority
Customer order flow enhances liquidity on the Exchange for the benefit
of all market participants. Priority Customer liquidity benefits all
market participants by providing more trading opportunities, which
attracts Market Makers and other market participants. An increase in
the activity of these market participants in turn facilitates tighter
spreads, which may cause an additional corresponding increase in order
flow from other market participants. Market Makers are assessed lower
transaction fees as compared to Public Customers that are not a
Priority Customer, Non-MIAX Market Makers, Non-Member Broker-Dealers,
and Firms because they have obligations to the market and regulatory
requirements, which normally do not apply to other market
participants.\9\ They have obligations to make continuous markets,
engage in a course of dealings reasonably calculated to contribute to
the maintenance of a fair and orderly market, and not make bids or
offers or enter into transactions that are inconsistent with a course
of dealings. In addition, charging non-members higher transaction fees
is a common practice amongst exchanges because Members are subject to
other fees and dues associated with their membership to the Exchange
that do not apply to non-members. The proposed differentiation as
between Priority Customers, Market Makers, and other market
participants recognizes the differing contributions made to the
liquidity and trading environment on the Exchange by these market
participants.
---------------------------------------------------------------------------

    \8\ See NASDAQ OMX PHLX LLC Pricing Schedule, Section II; NASDAQ
Options Market LLC's Pricing Schedule, Chapter XV.
    \9\ See Exchange Rules 603 and 604.
---------------------------------------------------------------------------

    The Exchange's proposal to offer MIAX Market Makers, Public
Customers that are not a Priority Customer, Non-MIAX Market Makers,
Non-Member Broker-Dealers, and Firms the opportunity to reduce
transaction fees by $0.02 per contract in standard options, provided
certain criteria are met, is reasonable because the Exchange desires to
offer all such market participants an opportunity to lower their
transaction fees. The Exchange's proposal to offer MIAX Market Makers,
Public Customers that are not a Priority Customer, Non-MIAX Market
Makers, Non-Member Broker-Dealers, and Firms the opportunity to reduce
transaction fees by $0.02 per contract in standard options, provided
certain criteria are met, is equitable and not unfairly discriminatory
because the Exchange will offer all market participants, excluding
Priority Customers, a means to reduce transaction fees by qualifying
for volume tiers in the Priority Customer Rebate Program. The Exchange
believes that offering all such market participants the opportunity to
lower transaction fees by incentivizing them to transact Priority
Customer order flow in turn benefits all market participants.
    The Exchange believes that the proposal to allow the aggregation of
trading activity of separate Members or its affiliates for purposes of
the fee reduction is fair, equitable and not unreasonably
discriminatory. The Exchange believes the proposed rule change is
reasonable because it would allow aggregation of the trading activity
of separate Members or its affiliates for purposes of the fee reduction
only in very narrow circumstances, namely, where the firm is an
affiliate, as defined herein. Furthermore, other exchanges, as well as
MIAX, have rules that permit the aggregation of the trading activity of
affiliated entities for the purposes of calculating and assessing
certain fees. The Exchange believes that offering all such market
participants the opportunity to lower transaction fees by incentivizing
them to transact Priority Customer order flow in turn benefits all
market participants.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The proposal is similar to the
transaction fees found on other options exchanges; therefore, the
Exchange believes the proposal is consistent with robust competition by
increasing the intermarket competition for order flow from market
participants. To the extent that there is additional competitive burden
on market participants without Priority Customer order flow, the
Exchange believes that this is appropriate because the proposal should
incent Members to direct additional order flow to the Exchange and thus
provide additional liquidity that enhances the quality of its markets
and increases the volume of contracts traded here. To the extent that
this purpose is achieved, all the Exchange's market participants should
benefit from the improved market liquidity. Enhanced market quality and
increased transaction volume that results from the anticipated increase
in order flow directed to the Exchange will benefit all market
participants and improve competition on the Exchange. The Exchange
notes that it operates in a highly competitive market in which market
participants can readily favor competing venues if they deem fee levels
at a particular venue to be excessive. In such an environment, the
Exchange must continually adjust its fees to remain competitive with
other exchanges and to attract order flow. The Exchange believes that
the proposal reflects this competitive environment.

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\10\ 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 shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

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_ADDRESS>Please
include File Number SR-MIAX-2014-46 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-MIAX-2014-46. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 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; 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-MIAX-2014-46 and should be
submitted on or before October 1, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-21521 Filed 9-9-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 121 (Monday, June 26, 2023)]
[Notices]
[Pages 41407-41408]
[FR Doc No: 2023-13428]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-1987]

Psychedelic Drugs: Considerations for Clinical Investigations;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Psychedelic Drugs: Considerations for Clinical Investigations.''
Because interest in the therapeutic potential of psychedelic drugs has
been increasing and designing clinical trials to evaluate these
compounds presents unique challenges, FDA has developed this draft
guidance to present foundational aspects for sponsors to consider. This
draft guidance provides general considerations for sponsors developing
psychedelic drugs for treatment of medical conditions (e.g.,
psychiatric disorders, substance use disorders) and discusses
considerations for clinical investigations using psychedelic drugs.

DATES: Submit either electronic or written comments on the draft
guidance by August 25, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-1987 for ``Psychedelic Drugs: Considerations for Clinical
Investigations.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-

0002. Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Kofi Ansah, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 4380, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Psychedelic Drugs: Considerations for Clinical
Investigations.'' This draft guidance outlines general considerations
for drug development programs considering the therapeutic potential of
psychedelic drugs for treatment of medical conditions (e.g.,
psychiatric disorders, substance use disorders).
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Psychedelic
Drugs: Considerations for Clinical Investigations.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 relating to the submission of
investigational new drug applications have been approved under OMB
control number 0910-0014. The collections of information in 21 CFR part
314 relating to the submission of new drug applications have been
approved under OMB control number 0910-0001. The collections of
information in 21 CFR parts 210 and 211 relating to current good
manufacturing practice requirements have been approved under OMB
control number 0910-0139. The collections of information relating to
the protection of human subjects and institutional review boards in 21
CFR parts 50 and 56 have been approved under OMB control number 0910-
0130.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: June 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13428 Filed 6-23-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 135 (Thursday, July 14, 2016)]
[Notices]
[Pages 45467-45468]
[FR Doc No: 2016-16668]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP16-125-000]

National Fuel Gas Supply Corporation; Notice of Schedule for
Environmental Review of the Line T2KNY Install, Line TNY Replacement,
and Line KNY Abandonment Project

    On April 4, 2016, National Fuel Gas Supply Corporation (National
Fuel) filed an application in Docket No. CP16-125-000 requesting a
Certificate of Public Convenience and Necessity pursuant to sections
7(b) and (c) of the Natural Gas Act to construct and abandon certain
natural gas pipeline facilities. The proposed project is known as the
Line T2KNY Install, Line TNY Replacement, and Line KNY Abandonment
Project (Project). The Project would eliminate vintage bare steel
pipeline, replacing it with modern, high strength, coated steel
pipeline, therefore increasing the overall integrity and reliability of
National Fuel's pipeline system.
    On April 15, 2016, the Federal Energy Regulatory Commission
(Commission or FERC) issued its Notice of Application for the Project.
Among other things, that notice alerted agencies issuing federal
authorizations of the requirement to complete all necessary reviews and
to reach a final decision on a request for a federal authorization
within 90 days of the date of issuance of the Commission staff's
Environmental Assessment (EA) for the Project. This instant notice
identifies the FERC staff's planned schedule for the completion of the
EA for the Project.

Schedule for Environmental Review

Issuance of EA August 3, 2016
90-day Federal Authorization Decision Deadline November 1, 2016

    If a schedule change becomes necessary, additional notice will be
provided so that the relevant agencies are kept informed of the
Project's progress.

Project Description

    National Fuel proposes to install approximately 1.2 miles of new
20-inch-diameter natural gas pipeline (Line T2KNY), replace
approximately 6.7 miles of 20-inch-diameter bare steel pipeline with
7.0 miles of 24-inch-diameter coated natural gas pipeline (Line TNY),
abandon approximately 14.9 miles of 20-inch-diameter bare steel natural
gas pipeline (Line KNY), make modifications at two existing National
Fuel meter and regulator stations (North Boston and East Eden), and
make modifications at National Fuel's existing Zoar Compressor Station
in Erie County, New York. The Line T2KNY Install, Line TNY Replacement,
and Line KNY Abandonment Project would allow National Fuel to cure
operating deficiencies on Line TNY and would provide an additional
2,600 dekatherms per day of new firm capacity which would be offered in
an open season.

Background

    On May 2, 2016, the Commission issued a Notice of Intent to Prepare
an Environmental Assessment for the Proposed Line T2KNY Install, Line
TNY Replacement, and Line KNY Abandonment Project and Request for
Comments on Environmental Issues (NOI). The NOI was sent to affected
landowners; federal, state, and local government agencies; elected
officials; environmental and public interest groups; Native American
tribes; other interested parties; and local libraries and newspapers.

    To date, no comments have been received on the NOI. The New York
State Department of Agriculture and Markets is a cooperating agency in
the preparation of the EA.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. This can
reduce the amount of time you spend researching proceedings by
automatically providing you with notification of these filings,
document summaries, and direct links to the documents. Go to
www.ferc.gov/docs-filing/esubscription.asp.
    Additional information about the Project is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC Web site (www.ferc.gov). Using the ``eLibrary'' link, select
``General Search'' from the eLibrary menu, enter the selected date
range and ``Docket Number'' excluding the last three digits (i.e.,
CP16-125), and follow the instructions. For assistance with access to
eLibrary, the helpline can be reached at<PHONE_NUMBER>, TTY (202) 502-
8659, or at<EMAIL_ADDRESS>The eLibrary link on the FERC
Web site also provides access to the texts of formal documents issued
by the Commission, such as orders, notices, and rule makings.

    Dated: July 7, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-16668 Filed 7-13-16; 8:45 am]
BILLING CODE 6717-01-P