[Federal Register Volume 77, Number 205 (Tuesday, October 23, 2012)]
[Notices]
[Pages 64845-64846]
[FR Doc No: 2012-25856]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Notice of Applications for Modification of Special Permit

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of applications for modification of special permits.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR part 107,
subpart B), notice is hereby given that the Office of Hazardous
Materials Safety has received the applications described herein. This
notice is abbreviated to expedite docketing and public notice. Because
the sections affected, modes of transportation, and the nature of
application have been shown in earlier Federal Register publications,
they are not repeated here. Requests for modification of special
permits (e.g. to provide for additional hazardous materials, packaging
design changes, additional mode of transportation, etc.) are described
in footnotes to the application number. Application numbers with the
suffix ``M'' denote a modification request. These applications have
been separated from the new application for special permits to
facilitate processing.

DATES: Comments must be received on or before November 7, 2012.
    Address Comments to: Record Center, Pipeline and Hazardous
Materials Safety Administration, U.S. Department of Transportation,
Washington, DC 20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Copies of the applications are
available for inspection in the Records Center, East Building, PHH-30,
1200 New Jersey Avenue Southeast, Washington, DC or at http://regulations.gov.
    This notice of receipt of applications for modification of special
permit is published in accordance with Part 107 of the Federal
hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR
1.53(b)).

    Issued in Washington, DC, on October 15, 2012.
Donald Burger,
Chief, General Approvals and Permits.

----------------------------------------------------------------------------------------------------------------
                                                                      Regulation(s)     Nature of special permit
     Application No.           Docket No.          Applicant             Affected                thereof
----------------------------------------------------------------------------------------------------------------
                            Modification of Special Permits
----------------------------------------------------------------------------------------------------------------
13232-M..................  .................  CP Industries,       49 CFR               To modify the special
                                               McKeesport, PA.      178.37(k)(2)(i);     permit to remove the
                                                                    178.37(1);           requirement for
                                                                    178.45(j)(1);        maintaining a copy of
                                                                    178.45(k)(2).        the special permit
                                                                                where each package is
                                                                                offered or reoffered
                                                                                for transportation.
14188-M..................  .................  IDQ Operating Inc.,  49 CFR 173.304(d),   To modify the special
                                               Tarrytown, NY.       173.306(a)(3) and    permit to reflect
                                                                    178.33a.             current statutes and
                                                                                regulations pertaining
                                                                                to consumer
                                                                                commodities.
15599-M..................  .................  Vodik Labs, LLC      49 CFR 173.311.....  To modify the special
                                               (formerly Ovonic                          permit originally
                                               Hydrogen Systems),                        issued on an emergency
                                               Fort Worth, TX.                           basis to authorize an
                                                                                additional two years.
15655-M..................  .................  Walt Disney Parks    49 CFR 173.56(b)     To modify the special
                                               and Resorts U.S.     and 172.320.         permit to authorize an
                                               Inc., Anaheim, CA.                        additional packaging
                                                                                configuration.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2012-25856 Filed 10-22-12; 8:45 am]
BILLING CODE 4909-60-M


[Federal Register Volume 86, Number 182 (Thursday, September 23, 2021)]
[Notices]
[Pages 52912-52914]
[FR Doc No: 2021-20517]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0401]

Donor Eligibility for Animal Cells, Tissues, and Cell- and
Tissue-Based Products; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency or we) is
announcing the availability of a draft guidance for industry #254
entitled ``Donor Eligibility for Animal Cells, Tissues, and Cell- and
Tissue-Based Products.'' FDA's Center for Veterinary Medicine (CVM) is
issuing this guidance

for sponsors, firms, individuals, and establishments that participate
in the manufacture of, or perform any aspect of, the donor eligibility
determination for animal cells, tissues, and cell- and tissue-based
products (ACTPs), which meet the definition of new animal drugs under
the Federal Food, Drug, and Cosmetic Act (FD&C Act). Donor eligibility
is a critical component of current good manufacturing practices (CGMPs)
when manufacturing ACTPs. A donor should be considered eligible to
donate ACTPs only if screening of the donor shows that the donor is
free from risk factors for, and clinical evidence of, infection with
relevant disease agents and diseases, and the donor (and product/source
material) test results for relevant disease agents are negative or
nonreactive.

DATES: Submit either electronic or written comments on the draft
guidance by November 22, 2021 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-2021-D-0401 for ``Donor Eligibility for Animal Cells, Tissues, and
Cell- and Tissue-Based Products.'' 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 guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
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: Lynne Boxer, Center for Veterinary
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
(GFI) #254 entitled ``Donor Eligibility for Animal Cells, Tissues, and
Cell- and Tissue-Based Products.'' This draft guidance is for sponsors,
firms, individuals, and establishments that participate in the
manufacture of, or perform any aspect of, the donor eligibility
determination for ACTPs, which meet the definition of new animal drugs
under section 201(v) of the FD&C Act (21 U.S.C. 321(v)). ACTPs that are
intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease or are intended to affect the structure or
function of the animal generally meet the definition of a new animal
drug. All new animal drugs, including ACTPs, are required to be
manufactured in accordance with CGMPs to ensure that such drugs meet
the requirements of the FD&C Act as to safety, and have the identity,
strength, quality, and purity characteristics that they purport to or
are represented to possess. Advances in the field of veterinary
regenerative medicine have resulted in increasing research into
veterinary applications for ACTPs, and many of these products are
intended for use as new animal drugs.
    Donor eligibility is a critical component of CGMPs when
manufacturing ACTPs. Selecting appropriate donors is critical to
product quality and compliance with ACTP CGMPs. Establishments
performing any function related to donor eligibility should comply with
the ACTP CGMPs related to that function. A donor should be considered
eligible to donate ACTPs only if screening of the donor shows that the
donor is free from risk factors for, and clinical evidence of,
infection with relevant disease agents and

diseases, and the donor (and product/source material) test results for
relevant disease agents are negative or nonreactive. To prevent
transmission of disease when manufacturing ACTPs, it is necessary to
determine that donors are healthy and free from relevant disease
agents. Transmission of relevant disease agents by an ACTP may be the
result of the presence of relevant disease agents in the donated cells/
tissues (either within the cells/tissues, within other accompanying
cells/tissues, or in the extracellular components of the product).
    The CGMP requirements for new animal drugs are found in Title 21
parts 210 and 211 of the Code of Federal Regulations (21 CFR parts 210
and 211). These regulations are broad in scope, and FDA recognizes that
they do not specifically or fully address some aspects of the
manufacture of ACTPs, including donor eligibility determinations. This
guidance offers FDA's recommendations for determining that a donor is
free from relevant disease agents and is an eligible source of cells,
tissues, or both, used in the manufacture of allogeneic or xenogeneic
ACTPs. We encourage sponsors and manufacturers of ACTPs to contact CVM
early in the product development process to discuss considerations
specific to approval of a new animal drug product.
    This level 1 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 donor
eligibility for animal cells, tissues, and cell- and tissue-based
products. 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 514 have been approved under OMB control
number 0910-0032.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: September 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-20517 Filed 9-22-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: August 11, 2008 (Volume 73, Number 155)]
[Notices]
[Page 46693-46695]
[DOCID:fr11au08-128]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58292; File No. SR-DTC-2008-07]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Filing of Proposed Rule Change to Implement Processing
Enhancements to the Profile Modification System Used in the Direct
Registration System

August 1, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on July 7, 2008, The
Depository Trust Company (``DTC'') filed with the Securities and
Exchange Commission (``Commission'') proposed rule change No. SR-DTC-
2008-07. The Commission is publishing this notice to solicit comments
from interested parties on the proposed rule change as described in
Items I, II, and III below, which items have been prepared primarily by
the DTC.\2\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ The exact text of the DTC's proposed rule change can be
found at http://www.dtcc.com/legal/rule_filings/dtc/2008.
---------------------------------------------------------------------------

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

    DTC is proposing to enhance its Profile Modification System in
order to allow a ``move all'' instruction and to allow a second
taxpayer identification number or social security number to be used to
verify instructions, DTC is also proposing to impose new participant
fees to reimburse transfer agents for the cost of implementing and
maintaining the proposed Profile enhancements.

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 DTC 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. DTC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.\3\
---------------------------------------------------------------------------

    \3\ The Commission has modified portions of the text of the
summaries prepared by the DTC.
---------------------------------------------------------------------------

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

1. Purpose
    The Direct Registration System (``DRS'') allows investors to hold
their securities positions on the records of the issuer in book-entry
form rather than in certificated form. In May 2000, DTC established the
Profile Modification System (``Profile'') which allows its participants
(i.e., broker-dealers and banks) and DRS Limited Participants (i.e.,
transfer agents) to electronically change an investor's securities
positions from street-name ownership to direct registration book-entry
position and vice versa.\4\ Specifically, Profile allows

participants to electronically submit an investor's instruction that
its share positions be moved from the investor's DRS account to the
investor's broker-dealer's participant account at DTC. Profile also
allows DRS Limited Participants to submit an investor's instruction for
the movement of its share positions from the investor's broker-dealer's
participant account at DTC to an account maintained by the DRS Limited
Participant. Currently, DTC receives on average approximately 50,000
Profile instructions per month and that volume is expected to rise.
---------------------------------------------------------------------------

    \4\ Transfer agents acting as DRS Limited Participants must meet
certain criteria established by DTC, which includes, among other
things, that the transfer agent also be eligible to participate in
DTC's Fast Automated Securities Transfer Program (``FAST''). For
securities that are part of FAST, the DRS Limited Participants hold
the securities registered in the name of DTC's nominee, Cede & Co.,
in the form of balance certificates. As additional securities are
deposited or withdrawn (``deposit-by-transfer'' and ``withdrawal-by-
transfer'', respectively) from DTC, the DRS Limited Participant
adjusts the denomination of the balance certificate as appropriate,
and electronically confirms these changes with DTC. As such, the
program reduces the movement of physical certificates between DTC
and DRS Limited Participants, reducing costs and risks to DTC, its
participants, issuers and transfer agents associated with the
creation, movement, and storing of certificates. For a description
of DTC's current rules relating to FAST, see Securities Exchange Act
Release Nos. 13342 (March 8, 1977) (File No. SR-DTC-76-3); 14997
(July 26, 1978) (File No. Sr-DTC-78-11); 21401 (October 16, 1984)
(File No. SR DTC-84-8); 31941 (March 3, 1993) (SR-DTC-92-15); and
46956 (December 2, 2002) (File No. SR-DTC 2002-15).
    In addition, DTC has filed a proposed rule change with the
Commission relating to updating its FAST and DRS program
requirements. See Securities Exchange Act Release No. 57362
(February 20, 2008) [File No. SR-DTC-2006-16].
---------------------------------------------------------------------------

    As the use of DRS continues to grow, attention has centered on
reducing the number of rejected instructions submitted through Profile.
In order to effectively transfer an investor's securities position
using Profile, the participant must enter into Profile an instruction
containing certain identifying criteria of the investor, such as share
quantity and a taxpayer identification number (``TIN'') or Social
Security number. If the submitted information does not match the
information the DRS Limited Participant has on its file, the Profile
instruction is rejected, which may result in a rejection fee assessed
by the DRS Limited Participant. More importantly, the rejection can
also result in delays in transferring the position, possibly causing
financial harm to an investor.
    Today, nearly 25% of all Profile instructions are rejected by the
transfer agents. The two most common reasons for rejections are the
Profile instruction not matching the share quantity and the Profile
instruction not matching the investor's TIN or Social Security number
on the transfer agent's records. The DRS Ad Hoc Committee, an industry
committee established to address operational issues related to DRS,
believes that by implementing certain system and processing
improvements, the industry can potentially eliminate about 7,000
Profile rejections per month.
    a. Proposed Changes to Profile
    In an effort to decrease the number of rejections in Profile,
members of the DRS Ad Hoc Committee have agreed that DTC should enhance
the Profile functionality and that these changes should be required of
all Profile users. Accordingly, DTC is proposing to make the following
enhancements to Profile functionality:
    Move All Instruction. Currently, Profile requires a participant to
enter a specific share quantity or dollar value (in the case of debt)
in their Profile instruction. Under the proposed rule change, the
participant submitting an instruction in Profile would be allowed to
select one of the following options: (1) Enter a specific share
quantity or dollar value; (2) move all of the investor's whole shares
\5\ to the requesting participant's account at DTC; (3) move all of the
investor's whole shares to the requesting participant's account at DTC,
liquidate any fractional share positions remaining in the account at
the transfer agent, and have the cash proceeds mailed directly to the
investor; (4) move all of the investor's whole shares to the requesting
participant's account at DTC, liquidate any fractional share positions
remaining in the account at the transfer agent, have the cash proceeds
mailed directly to the investor, and close the investor's DRS and
Dividend Reinvestment Plan (``DRIP'') account.\6\ By using the ``move-
all'' functionality, participants can forgo referencing a specific
share quantity in the Profile instruction, which DTC believes should
eliminate a major cause of Profile rejections.\7\
---------------------------------------------------------------------------

    \5\ DTC's systems only process whole shares, not fractional
shares and only allow whole shares to be held in participants'
accounts at DTC.
    \6\ Some transfer agents maintain separate investor accounts for
DRIP shares and DRS positions. The participant's instruction via
Profile to close the account would require a DRS Limited Participant
to close both the DRIP and the DRS account.
    \7\ Although DRS Limited Participants are able to enter Profile
instructions to move DRS positions from a participant account at DTC
to the investor's account on the books of the issuer, the proposed
rule change will not permit the ``move all'' function in Profile to
be available to the DRS Limited Participant at this time.
---------------------------------------------------------------------------

    Dual TIN or Social Security Numbers. Currently, participants are
permitted to enter only one TIN or Social Security number in its
Profile instruction. Under the proposed rule change, participants may
elect to submit a Profile instruction with two TINs or Social Security
numbers instead of one. The option to submit a Profile instruction with
two TIN or Social Security numbers may be necessary, for example, where
the investor's account is a joint account. For those Profile
instructions with two TIN or Social Security Numbers, the DRS Limited
Participant will only need to match one of the TIN or Social numbers on
the Profile instruction to the DRS Limited Participant's records for
the investor account.
    The proposed rule change will require participants and DRS Limited
Participants that process their DRS transactions through a direct
electronic computer-to-computer link with DTC to make internal system
enhancements to accommodate DTC's changes to Profile.\8\ Specifically,
internal systems will need to be enhanced so that they are able to
accept DRS Profile instructions to ``move all'' shares from the
investor's DRS Limited Participant account to the investor's
participant's account at DTC. They will also need to be enhanced so
that they are able to allow participants to submit Profile transactions
with a second TIN/Social security number.
---------------------------------------------------------------------------

    \8\ It is anticipated that for those users that communicate
Profile instructions through DTC via a dedicated terminal (PTS or
PBS), they will only need to update their internal procedures and
workflow.
---------------------------------------------------------------------------

    b. Proposed Remuneration
    Members of the DRS Ad Hoc Committee have also agreed that
participants will pay DRS Limited Participants two types of
remuneration: (1) Reimbursement to compensate for the initial system
development of the enhancements contemplated under the move-all
proposal and (2) a transaction fee to pay for the on-going
administration of the proposed new functions. Accordingly, DTC is
proposing to require participants to pay for seventy-five percent of
all system costs with a maximum payment of $200,000 per DRS Limited
Participant for project plans submitted by DRS Limited Participants to
DTC by September 1, 2008. For project plans that will be managed by a
third party vendor, participants would be required to pay a
remuneration based on the vendor's total project cost. DTC would act as
a conduit to collect and distribute the remuneration from the
participants to DRS Limited Participants.
    Under the proposed rule change, DRS Limited Participants will be
required to submit a project plan to DTC by September 1, 2008, and be
ready to implement the ``move all'' Profile functionality by November
1, 2008, in order to be eligible to receive the system cost
remuneration. DTC will make a one time payment to eligible DRS Limited
Participants no later than 90 calendar days after the completion of the
move all and dual TIN or Social security functionality going live. DTC
proposes to collect a surcharge of $1.00 from participants, for no more
than twenty-

four calendar months, for each Profile transaction submitted by a
participant in order to offset the up-front remuneration made by DTC to
DRS Limited Participants. DTC will eliminate the surcharge at the end
of twenty-four calendar months or sooner if the total amount of up-
front remuneration paid by DTC is collected before the twenty-four
month period has expired.
    DTC also proposed to charge participants $.75 per Profile
transaction to offset the on-going cost to DRS Limited Participants of
supporting the ``move all'' function. The transaction fee will be
adjusted annually to reflect DRS Profile transactional volume changes.
The proposed rule change will require DRS Limited Participants that
wish to receive a transaction fee to submit their project plan by
September 1, 2008. The DRS Limited Participants represented on the DRS
Ad Hoc Committee have agreed that the monthly transactional fee will be
no more than $25,000 per year per DRS Limited Participant. DTC will pay
each eligible DRS Limited Participant with 2,000 or more Profile
transactions monthly a set monthly amount of $2,080, or $24,960
annually. DTC will pay each eligible DRS Limited Participant with at
least 200 transactions monthly but less than 2,000 transactions monthly
a set monthly amount of $800, or $9,600 annually. DTC will not pay DRS
Limited Participants with less than 200 transactions a month.
    c. Proposed DRS Limited Participant Eligibility Requirements
    DTC proposes to amend its DRS Limited Participant rules to require
transfer agents to be able to process Profile instructions requesting
the ``move all'' options and instructions including dual TIN or Social
Security numbers. To maintain eligibility as a DRS Limited Participant,
all current DRS Limited Participants must provide ``move all'' and dual
TIN or Social Security number processing capability by no later than
December 31, 2008.
2. Statutory Basis
    DTC believes the proposed rule change is consistent with the
requirements of Section 17A of the Act, as amended,\9\ and the rules
and regulations thereunder because it improves efficiency and reduces
risks associated with processing DRS transaction through Profile and
improves the standards relating to the eligibility of transfer agents
effecting DRS transactions.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

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

    DTC 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

    DTC has neither solicited nor received written comments on the
proposed rule change.

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

    Within thirty-five days of the date of publication of this notice
in the Federal Register or within such longer period: (i) As the
Commission may designate up to ninety days of such date if it finds
such longer period to be appropriate and publishes its reasons for so
finding or (ii) as to which the self-regulatory organization consents,
the Commission will:
    (A) By order approve such proposed rule change or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml) or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-DTC-2008-07 in 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-DTC-2008-07. 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 Section, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3:30 p.m. Copies of such filings also will be available
for inspection and copying at the principal office of the DTC and on
the DTC's Web site, http://www.dtcc.com. 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-DTC-2008-07 and should be submitted on
or before September 2, 2008.

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

    \10\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-18421 Filed 8-8-08; 8:45 am]

BILLING CODE 8025-01-P


[Federal Register Volume 79, Number 26 (Friday, February 7, 2014)]
[Notices]
[Pages 7470-7471]
[FR Doc No: 2014-02708]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2013-1084]

Draft Policy Letters: Guidance for the Use of Liquefied Natural
Gas as a Marine Fuel

AGENCY: Coast Guard, DHS.

ACTION: Notice of availability and request for comments.

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

SUMMARY: The Coast Guard announces the availability, in the docket, of
two draft policy letters for which it seeks public comment. The first
draft policy letter provides voluntary guidance for liquefied natural
gas (LNG) fuel transfer operations on vessels using natural gas as fuel
in U.S. waters, and training of personnel on those vessels. It
recommends transfer and personnel training measures that we believe
will achieve a level of safety that is at least equivalent to that
provided for traditional fueled vessels. It would apply to vessels
equipped to receive LNG for use as fuel, but not to vessels carrying
LNG as cargo that use boil-off gas as fuel. The second draft policy
letter discusses voluntary guidance and existing regulations applicable
to vessels and waterfront facilities conducting LNG marine fuel
transfer (bunkering) operations. The second draft policy letter
provides voluntary guidance on safety, security, and risk assessment
measures we believe will ensure safe LNG bunkering operations. We
request your comments on these draft policy letters before signature
and public release.

DATES: Comments and related material must either be submitted to our
online docket via http://www.regulations.gov on or before March 10,
2014 or reach the Docket Management Facility by that date.

ADDRESSES: You may submit comments identified by docket number USCG-
2013-1084 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Ken Smith, Vessel and Facility Operating Standards
Division (CG-OES-2), U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Cheryl Collins, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to submit comments and related material on the
proposed draft policy letters and voluntary guidance described in this
notice. All comments received will be posted, without change, to http://www.regulations.gov and will include any personal information you have
provided.
    Submitting comments: If you submit a comment, please include the
docket number for this notice (USCG-2013-1084) and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online, or by fax, mail or hand delivery, but please use only
one of these means. We recommend that you include your name and a
mailing address, an email address, or a telephone number in the body of
your document so that we can contact you if we have questions regarding
your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number (USCG-2013-1084) in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this notice. If you submit your comments by mail or hand delivery,
submit them in an unbound format, no larger than 8\1/2\ by 11 inches,
suitable for copying and electronic filing. If you submit them by mail
and would like to know that they reached the Facility, please enclose a
stamped, self-addressed postcard or envelope. We will consider all
comments and material received during the comment period.
    Viewing the comments and material in the docket: To view the policy
letters and comments on it, go to http://www.regulations.gov, type the
docket number (USCG-2013-1084) in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Open Docket Folder'' on the line associated with
this notice. If you do not have access to the internet, you may view
the docket online by visiting 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. We
have an

agreement with the Department of Transportation to use the Docket
Management Facility.
    Privacy Act: Anyone can search the electronic form of comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review a
Privacy Act, system of records notice regarding our public dockets in
the January 17, 2008, issue of the Federal Register (73 FR 3316).

Background and Purpose

    The shipping industry is exploring conversion from oil-based bunker
fuel to cleaner burning natural gas, because the use of natural gas as
vessel fuel would substantially reduce carbon emissions, sulfur
emissions, and nitrogen oxide emissions. This fuel would be stored on
and transferred to vessels in the form of liquefied natural gas (LNG).
To date, the Coast Guard has issued no policy or regulations
specifically for vessels receiving LNG for use as fuel or for vessels
and waterfront facilities providing LNG for use as fuel. Existing
regulations cover design, equipment, operations, and training of
personnel on vessels that carry LNG as cargo and at waterfront
facilities that handle LNG in bulk. They also cover conventional oil
fuel transfer operations, but do not address LNG transferred as fuel.
The shipping industry, including vessels and waterfront facilities
intending to provide LNG as fuel, is looking to the Coast Guard to
provide guidance to help ensure the safe transfer and use of LNG as a
marine fuel.
    The Coast Guard has developed two draft policy letters, available
in the docket, that recommend transfer procedures and other operating
guidelines for vessels and waterfront facilities providing LNG to
vessels for use as fuel and for vessels operating in U.S. waters that
will be fueled with natural gas that will be stored onboard as LNG. The
Coast Guard is interested in receiving public comment on these draft
policy letters and voluntary guidelines prior to finalizing them for
signature and public release. At a future date, we may initiate a
rulemaking on the topics discussed in these policy letters.
    The draft policy letters and voluntary guidance would not apply to
vessels that carry LNG as cargo and utilize their boil-off gas as fuel.
They also would not provide guidance on vessel design criteria for
natural gas fuel systems or design of vessels providing LNG for use as
fuel. Questions related to the design of these systems should be
referred to the Coast Guard's Office of Design and Engineering
Standards (CG-ENG, formerly CG-521). To communicate with CG-ENG, please
contact Mr. Ken Smith (see FOR FURTHER INFORMATION CONTACT section for
details).

Voluntary Policy

    The draft policy letters proposed would be voluntary, except where
existing regulatory requirements are discussed. Although they may
assist the industry, public, Coast Guard, and other Federal and State
regulators in applying existing statutory and regulatory requirements,
the draft policy letters and guidance they contain are not a substitute
for applicable legal requirements nor are they regulations themselves.
We note the ongoing work of the International Maritime Organization in
this area, in particular regarding training of personnel engaged in
these operations. Developments within this body will be taken into
account during possible future revisions of the draft policy letters.
During the course of local operations, each Coast Guard Captain of the
Port (COTP) has discretionary authority on how best to address specific
safety and security concerns within his or her area of responsibility
(see, e.g., 33 CFR 1.01-30). Nothing in the draft policy letters and
guidance they contain are meant to override or subvert the discretion
of the COTP when addressing the unique safety and security concerns of
an LNG operation.
    This notice is issued under authority of 5 U.S.C. 552(a) and 33
U.S.C. 1221-1236.

    Dated: February 3, 2014.
J.G. Lantz,
Director of Commercial Regulations and Standards, U.S. Coast Guard.
[FR Doc. 2014-02708 Filed 2-6-14; 8:45 am]
BILLING CODE 9110-04-P