1 Technical Support Document on Changes from the Proposed Model Hg Trading Rule to the Final Model Hg Trading Rule The proposed and final model Hg Budget trading rules are modeled after, and are largely the same as, the NOX SIP Call model trading rule. The final model Hg Budget trading rule ( in subpart HHHH of part 60) includes some changes to the regulatory text that improve the implementability of the rules or clarify aspects of the rules identified by the EPA or commenters.

One example of where the final model trading rule incorporates changes from the proposed model trading rule involves the provisions in the standard requirements concerning liability under the trading program. The proposed model trading rule included, under the standard requirements in § § 60.4106( f)( 1) and ( 2), provisions stating that any person who knowingly violates the Hg Budget trading program or knowingly makes a false material statement under the trading program will be subject to enforcement action under applicable State or Federal law. Similar provisions are included in § 96.6( f)( 1) and ( 2) of the final NOX SIP Call model trading rule. The final model Hg Budget trading rule excludes these provisions for the following reasons. First, the proposed rule provisions are unnecessary because, even in their absence, applicable State or Federal law authorizes enforcement actions and penalties in the case of knowing violations or knowing submission of false statements. Moreover, these proposed rule provisions are incomplete. They do not purport to cover, and have no impact on, liability for violations that are not knowingly committed or false submissions that are not knowingly made. Applicable State and Federal law already authorizes enforcement actions and penalties, under appropriate circumstances, for non knowing violations or false submissions. Because the proposed rule provisions are unnecessary and incomplete, the final model trading rule does not include these provisions. However, EPA emphasizes that, on their face, the provisions that were proposed, but eliminated in the final rule, in no way limit liability, or the ability of the State or EPA to take enforcement action, to only knowing violations or knowing false submissions.

By further example of a change in the final model trading rule, the standard requirements ( in § 60.4106) concerning excess emissions are revised in the final rule by moving provisions concerning each ounce of excess emissions and each day in the control period when excess emissions occur from other sections ( e. g., the compliance deduction section, § 60.4154) of the proposed model trading rule to the excess emissions standard 2 requirements provisions in the final model trading rule.

Other changes reflected in the regulatory text of the final model Hg Budget trading rule include: 1. The definitions of " commence commercial operation", " commence operation", " maximum design heat input", and " nameplate capacity" are clarified in order to address circumstances when there are physical changes to a unit. The basic approach    that once a unit meets at any time the basic criteria for inclusion in the trading programs, the unit remains subject to the trading program regardless of any subsequent changes to the unit or its operation  to applicability in the proposed model trading rule is maintained. The definition of " State" is clarified with regard to its application to certain Indian tribes and Indian country. 2. The definitions of most stringent State or Federal emissions limitations and of " repowering" are added for clarification. The former definition is based on the definition in the NOX SIP Call model trading rule, and the latter definition is based on the definition in title IV of the Clean Air Act. Several other definitions ( e. g., of " Acid Rain emissions limitation", " combustion turbine"," lignite", " subbituminous", and " unit") are also added for clarification. 3. The term " Hg authorized account representative" is replaced by the term " Hg designated representative" when referring to the representative of a Hg Budget source or unit. 4. The purpose section of the rule ( § 60.4101) is expanded to clarify that owners or operators of units or sources are subject to the rules only if the State with jurisdiction over the units or sources adopts, and the Administrator approves the State's adoption of, the requirements of the rules. The purpose section also clarifies that, in adopting the rules, a State is authorizing the Administrator to assist the State by carrying out the Administrator functions set forth in the rules. The revised language is similar to language in the purpose section of the NOX SIP Call model trading rule. 5. The applicability provisions for cogeneration units are revised to add efficiency and operating requirements analogous to those adopted for cogeneration units under the CAIR model trading programs, for the same reasons that they were adopted in the CAIR. The applicability provisions are also revised to make it clear that once a unit fails at any time to qualify for a cogeneration unit exemption and becomes subject to the trading program, the unit cannot subsequently become exempt from the trading program. 3 Several definitions ( e. g., of " bottoming cycle cogeneration unit", " gross electrical output", " topping cycle cogeneration unit", " sequential use of energy", " total energy input", " total energy output", " useful power", and " useful thermal energy" are added for clarification of efficiency and operating requirements for cogeneration units. These definitions are based on similar definitions in the Federal Energy Regulatory Commission's regulations concerning qualifying cogeneration facilities ( 18 C. F. R. 292.202). The definition of " utility power distribution system" is also added, based on the definition of a similar term " power distribution system" in the Acid Rain Program regulations ( 40 C. F. R. 70.2). 6. Provisions for administrative appeals of final actions of the Administrator under the model trading rule are added by referencing, and explaining how to apply, the administrative appeals procedures in part 78 that apply to the Acid Rain Program and the CAIR model trading programs. 7. The liability provision in § 60.4106( f)( 6) is revised to remove language that is inconsistent with the application of the Hg allowance holding requirement on a source level, rather than unit level, basis. 8. The permitting provisions are clarified concerning the deadline for submission of Hg Budget permit applications and the term of Hg Budget permits. 9. The timing requirements for Hg allowance allocations are clarified to apply to allocations from the new unit setaside ( as well as allocation for units with baseline heat input values). These requirements are also clarified to provide that if a permitting authority fails to submit the allocations to the Administrator, the Administrator will generally assume that each unit's allocation is the same as in the immediately preceding control period, taking into account the greater emission reductions required starting in 2018 and the need to avoid double allocations to a unit ( i. e., from both the allowance pools for units with baseline heat input values and for new units). 10. The provisions for allocations for new units are revised to base the allocations on a new unit's actual Hg emissions in the prior year, rather than allocating allowances based on the unit's maximum design output and then requiring the unit to surrender allowances to the extent the unit's actual utilization during the year for which the allocation is made is less than the maximum. The provisions in the final Hg trading rule are adopted for the same reasons this approach is adopted in the CAIR model trading rules. The approach in the proposed Hg trading rule is similar to that in the NOX SIP Call model trading rule. In administering the NOX SIP 4 Call EPA found that this approach of providing allowances and then taking some back based on actual operating results is confusing to owners and operators and that this confusion can result in unintentional violations of the allowanceholding requirement. This approach is also difficult to administer. 11. Provisions concerning multiple owners of allowances allocated to a Hg Budget unit are added, consistent with similar provisions in the Acid Rain Program and the CAIR model trading programs. 12. Provisions requiring annual compliance certification reports are removed for the same reason that such provisions are removed in the Acid Rain Program and that such reports are not required in the CAIR model trading programs. 13. The descriptions of compliance and general accounts in the allowance tracking systems under § § 96.150 and 96.250 are removed as duplicative of other provisions in the model trading rule. 14. The descriptions of compliance and general accounts in the allowance tracking systems under § § 96.150 and 96.250 are removed as duplicative of other provisions in the model trading rules. 15. The language on closing of general accounts is clarified. 16. The provisions for the Administrator's recordation of Hg allowance allocations are clarified and made to be consistent with the timing for the permitting authority's submission of allocations to the Administrator. 17. The provision on deduction of Hg allowances for excess emissions is clarified concerning from what year Hg allowances are to be deducted. 18. The exemption from the initial monitoring system certification procedures is clarified. 19. The monitoring provisions, and the definition of " continuous emission monitoring system", are revised to be consistent with the monitoring requirements in the final Hg mass monitoring provisions in part 75. 20. The provision under § 60.4175 regarding review and approval of petitions for CAIR NOX units for alternatives to monitoring, reporting, and recordkeeping requirements is clarified to state that, in all cases, such petitions must be approved by the Administrator, in consultation with the permitting authority, before such alternatives may be used by owners and operators.


[Federal Register Volume 75, Number 214 (Friday, November 5, 2010)]
[Notices]
[Page 68350]
[FR Doc No: 2010-27989]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ID-6422-000]

Fischer, Thomas J.; Notice of Filing

October 29, 2010.
    Take notice that on October 29, 2010, Thomas J. Fischer filed an
Application for Authorization to Hold Interlocking Positions as
Director of Wisconsin Electric Power Company, Director of Actuant
Corporation, and Director of Regal-Beloit Corporation, pursuant to
section 305(b) of the Federal Power Act.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on November 19, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-27989 Filed 11-4-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 137 (Wednesday, July 19, 2017)]
[Notices]
[Page 33101]
[FR Doc No: 2017-15094]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER17-742-001; ER10-1342-004; ER10-1886-007.
    Applicants: CP Bloom Wind LLC, CP Energy Marketing (US) Inc.,
Decatur Energy Center, LLC.
    Description: Notice of Change in Status and Limited Request for
Privileged Treatment of CP Bloom Wind LLC, et al.
    Filed Date: 7/12/17.
    Accession Number: 20170712-5200.
    Comments Due: 5 p.m. ET 8/2/17.

    Docket Numbers: ER17-1780-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Tariff Amendment: 2017-07-12 SA 1677 Illinois Power-
Ameren Substitute Amended GIA to be effective 5/25/2017.
    Filed Date: 7/12/17.
    Accession Number: 20170712-5178.
    Comments Due: 5 p.m. ET 8/2/17.

    Docket Numbers: ER17-2084-000.
    Applicants: Great Bay Solar 1, LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Tariff and Waivers to be effective 8/29/2017.
    Filed Date: 7/12/17.
    Accession Number: 20170712-5195.
    Comments Due: 5 p.m. ET 8/2/17.

    Docket Numbers: ER17-2085-000.
    Applicants: Alliant Energy Corporate Services, Inc.
    Description: Sec.  205(d) Rate Filing: AECS Updated Schedule 2
(Reactive Power) to be effective 9/1/2017.
    Filed Date: 7/12/17.
    Accession Number: 20170712-5198.
    Comments Due: 5 p.m. ET 8/2/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 13, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-15094 Filed 7-18-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 212 (Thursday, November 3, 2022)]
[Notices]
[Page 66366]
[FR Doc No: 2022-23973]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2022-0077]

Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System

    Under part 235 of title 49 Code of Federal Regulations (CFR) and 49
U.S.C. 20502(a), this document provides the public notice that on July
22, 2022,\1\ Kansas City Southern (KCS) petitioned the Federal Railroad
Administration (FRA) seeking approval to discontinue or modify a signal
system. FRA assigned the petition Docket Number FRA-2022-0077.
---------------------------------------------------------------------------

    \1\ On October 13, 2022, KCS submitted a revised petition. Both
the original and revised petitions are available in the docket
(https://www.regulations.gov/document/FRA-2022-0077-0001).
---------------------------------------------------------------------------

    Specifically, KCS requests permission to decrease the limits of a
centralized traffic control (CTC) block signal system, from mile post
(MP) 9.9 to MP 11.2, near Laredo, Texas, as part of its Serrano Yard
expansion project. This permanent change would include removing control
point (CP) 10 and changing 1.3 miles of current CTC territory to yard
limits at restricted speed. KCS requests the change to expand capacity
for building trains in the Serrano Yard. In support of its petition,
KCS states that the change will minimally affect the safety of
operations because the maximum authorized speed in the area will
decrease from 59 miles per hour to restricted speed yard limits. KCS
also notes that this proposed change would bring the CTC/yard limits
``in coincidence between the main track and switching lead at CP 11,
reducing the risk of confusion for on track equipment.''
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted at http://www.regulations.gov. Follow the online instructions for submitting
comments.
    Communications received by January 3, 2023 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), the U.S. Department of Transportation (DOT)
solicits comments from the public to better inform its processes. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacy-notice for the privacy notice of
regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2022-23973 Filed 11-2-22; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 76, Number 146 (Friday, July 29, 2011)]
[Notices]
[Pages 45638-45642]
[FR Doc No: 2011-19190]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64955; File No. SR-FICC-2011-05]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
Notice of Filing of Proposed Rule Change To Amend the Rules Regarding
the GCF Repo Service To Adopt Changes Recommended by the Tri-Party Repo
Infrastructure Reform Task Force

July 25, 2011.
    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 July 12, 2011, the Fixed Income Clearing Corporation (``FICC'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared primarily by FICC. 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 purpose of the proposed rule change is to amend the rules
regarding the GCF Repo service to adopt changes recommended by the Tri-
Party Repo Infrastructure Reform Task Force (``TPR''). Because the GCF
Repo service operates as a tri-party mechanism, FICC has been requested
to incorporate changes to the GCF Repo service to align the service
with the other changes recommended by the TPR for the overall tri-party
repo market.

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

    In its filing with the Commission, FICC 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. FICC 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 the text of the summaries
prepared by FICC.
---------------------------------------------------------------------------

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

    (i) FICC is proposing to make certain changes to its GCF
Repo[supreg] \4\ service in order to comply with the recommendations
made by the TPR, an industry group formed and sponsored by the Federal
Reserve Bank of New York.\5\ Because the GCF Repo service operates as a
tri-party repo mechanism, FICC has been requested to incorporate
changes to the GCF Repo service to align the service with the other TPR
recommended changes for the overall tri-party repo market.
---------------------------------------------------------------------------

    \4\ GCF Repo is a registered trademark of FICC/DTCC.
    \5\ The main purpose of the TPR is to develop recommendations to
address the risk presented by tri-party repo transactions due to the
current morning reversal or ``unwind'' process and to move to a
process by which tri-party repo transactions are collateralized all
day. Currently, tri-party repo transactions unwind in the morning
between 7 and 8 a.m. EST. The GSD Schedule of GCF Timeframes
provides that the unwind of GCF Repo transactions (both overnight
and term) must be accomplished by 7:30 a.m. The TPR has mandated
that the collateral used in tri-party repo and GCF Repo transactions
be ``locked up'' until 3:30 p.m. EST. This would serve to reduce the
intraday exposure to the dealers that the clearing banks currently
face with the start of daily unwind.
---------------------------------------------------------------------------

    FICC is proposing to initially implement the changes described
herein in a pilot program (``Pilot Program''). FICC proposes to run the
Pilot Program for one year starting from the date on which the
Commission approves this proposed rule change filing. If FICC decides
to extend the Pilot Program or to implement the changes in the Pilot
Program permanently, FICC shall submit a proposed rule change filing to
the Commission for that purpose.
Background: Description of the GCF Repo Service and History
(1) Creation of the GCF Repo Service
    The GCF Repo service allows GSD dealer members to trade general

collateral repos \6\ throughout the day without requiring intra-day,
trade-for-trade settlement on a delivery-versus-payment (DVP) basis.
The service allows the dealers to trade such general collateral repos,
based on rate and term, throughout the day with inter-dealer broker
netting members on a blind basis. Standardized, generic CUSIP numbers
have been established exclusively for GCF Repo processing and are used
to specify the acceptable type of underlying Fedwire book-entry
eligible collateral, which includes Treasuries, Agencies and certain
mortgage-backed securities. \7\
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    \6\ A general collateral repo is a repo in which the underlying
securities collateral is nonspecific, general collateral whose
identification is at the option of the seller. This is in contrast
to a specific collateral repo.
    \7\ In 2009, the Commission approved FICC rule filing 2009-04 to
add debt securities issued under the Debt Guaranty Program component
of the Federal Deposit Insurance Corporation's (the ``FDIC's'')
Temporary Liquidity Guarantee Program (the ``TLGP'') to the GCF Repo
service. See Securities Exchange Act Release No. 34-58696
(September, 30, 2008), 73 FR 58698 (October 7, 2008). The TLGP, one
of the steps taken by the U.S. Government to stabilize the credit
markets and stimulate lending, was designed to allow banks to issue
FDIC-insured debt, ensuring that the banks would be able to roll
over any debt coming due in the coming months. The guarantee
consists of timely payment of principal and interest. The expiration
of the FDIC's guarantee is the earlier of either the maturity date
of the issued debt or June 2012.
---------------------------------------------------------------------------

    The GCF Repo service was developed as part of a collaborative
effort among the Government Securities Clearing Corporation (``GSCC'')
(FICC's predecessor), its two clearing banks (The Bank of New York
Mellon (``BNY'') and JPMorgan Chase Bank, National Association
(``Chase'')), and industry representatives. GSCC introduced the GCF
Repo service on an intra-clearing bank basis in 1998.\8\ Under the
intrabank service, dealers could only engage in GCF Repo transactions
with other dealers that cleared at the same clearing bank.
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 34-40623 (October
30, 2008), 69 FR 59831 (November 5, 1998).
---------------------------------------------------------------------------

(2) Creation of the Interbank Version of the GCF Repo Service
    In 1999, GSCC expanded the GCF Repo service to permit dealer
participants to engage in GCF Repo trading on an interbank basis,
meaning that dealers using different clearing banks could enter into
GCF Repo transactions (on a blind brokered basis).\9\ Because dealer
members that participate in the GCF Repo service do not all clear at
the same clearing bank, introducing the service as an interbank service
necessitated the establishment of a mechanism to permit after-hours
movements of securities between the two clearing banks to deal with the
fact that GSCC would likely have unbalanced net GCF securities and cash
positions within each clearing bank (that is, it is likely that at the
end of GCF Repo processing each business day, the dealers in one
clearing bank will be net funds borrowers, while the dealers at the
other clearing bank will be net funds lenders). To address this issue,
GSCC and its clearing banks established, and the Commission approved, a
legal mechanism by which securities would ``move'' across the clearing
banks without the use of the Fedwire Securities Service (``Fedwire
Securities'').\10\ (Movements of cash do not present the same issue
because the Fedwire Funds Service (``Fedwire Funds'') is open later
than Fedwire Securities). Therefore, at the end of the day, after the
GCF net results are produced, securities are pledged via a tri-party-
like mechanism and the interbank cash component is moved via Fedwire
Funds. In the morning, the pledges are unwound, that is, funds are
returned to the net funds lenders and securities are returned to the
net funds borrowers.
---------------------------------------------------------------------------

    \9\ See Securities Exchange Act Release No. 34-41303 (April 16,
1999), 64 FR 20346 (April 26, 1999).
    \10\ See Securities Exchange Act Release No. 34-41303 (April 16,
1999), 64 FR 20346 (April 26, 1999) for a detailed description of
the clearing bank and FICC accounts needed to effect the after-hour
movement of securities.
---------------------------------------------------------------------------

    The following simplified example illustrates the manner in which
the GCF Repo services works on an interbank basis:

    Assume that Dealer B clears at BNY and Dealer C clears at Chase.
Further assume that: (i) Outside of FICC, Dealer B engages in a tri-
party repo transaction with Party X to obtain funds and seeks to
invest such funds via a GCF Repo transaction; (ii) outside of FICC,
Dealer C engages in a DVP repo transaction with Party Y to buy
securities and seeks to finance these securities via a GCF Repo
transaction; and (iii) Dealer B and Dealer C enter into a GCF Repo
transaction (on a blind basis via a GCF Repo broker) and submit the
trade details to FICC.
    At the end of ``Day 1,'' GCF Repo collateral must be allocated,
i.e., Dealer B must receive the securities. However, the securities
that Dealer B is to receive are at Chase and Fedwire Securities is
closed. The after-hours movement mechanism permits the securities to
be ``sent'' to Dealer B as follows: FICC will instruct Chase to
allocate to a special FICC clearance account at Chase securities in
an amount equal to the net short securities position.
    FICC has established on its own books and records two
``securities accounts'' as defined in Article 8 of the New York
Uniform Commercial Code, one in the name of Chase (``FICC Account
for Chase'') and one in the name of BNY (``FICC Account for BNY'').
The FICC Account for Chase is comprised of the securities in FICC's
special clearance account maintained by BNY (``FICC Special
Clearance Account at BNY for Chase''), and the FICC Account for BNY
is comprised of the securities in FICC's special clearance account
maintained by Chase (``FICC Special Clearance Account at Chase for
BNY'').\11\ The establishment of these securities accounts by FICC
in the name of the clearing banks enables the clearing bank that is
in the net long securities position to ``receive'' securities by
pledge after the close of Fedwire Securities. Once the clearing bank
has ``received'' the securities by pledge, it can credit them by
book-entry to a FICC GCF Repo account at that clearing bank and then
to the dealers that clear at that bank that are net long the
securities in connection with GCF Repo trades.
---------------------------------------------------------------------------

    \11\ FICC has appointed Chase as its agent to maintain FICC's
books and records with respect to the BNY securities account, and
FICC has appointed BNY as its agent to maintain FICC's books and
records with respect to the Chase securities account.
---------------------------------------------------------------------------

    In the example, Chase, as agent for FICC, will transmit to BNY a
description of the securities in the FICC Special Clearance Account
at Chase for BNY. Based on this description, BNY will transfer funds
equal to the funds borrowed position to the FICC GCF Repo account at
Chase. Upon receipt of the funds by Chase, Chase will release any
liens it may have on the FICC Special Clearance Account at Chase for
BNY, and FICC will release any liens it may have on the FICC Account
for BNY (both of these accounts being comprised of the same
securities). BNY will credit the securities in the FICC Account for
BNY to FICC's GCF Repo account at BNY, and BNY will further credit
these securities to Dealer B, who, as noted, is in a net long
securities position. In the morning of ``Day 2,'' all securities and
funds movements occurring on Day 1 are reversed (``unwind'').
(3) Issues With Morning Unwind Process
    In 2003, FICC shifted the GCF Repo service back to intrabank status
only.\12\ By that time, the service had grown significantly in
participation and volume. However, with the increase in use of the
interbank service, certain payments systems risk issues arose from the
inter-bank funds settlements related to the service, namely, the large
interbank funds movement in the morning. FICC shifted the service back
to intrabank status to enable management to study the issues presented
and identify a satisfactory solution for bringing the service back to
interbank status.
---------------------------------------------------------------------------

    \12\ See Securities Exchange Act Release No. 34-48006 (June 10,
2003), 68 FR 35745 (June 16, 2003).
---------------------------------------------------------------------------

(4) The NFE Filing and Restoration of Service to Interbank Status
    In 2007, FICC submitted to the Commission a proposed rule change to

address the issues raised by the interbank morning funds movement and
return the GCF Repo service to interbank status (``2007 NFE
Filing'').\13\ The 2007 NFE Filing addressed these issues by using a
hold against a dealer's ``net free equity'' (``NFE'') at the clearing
bank to collateralize its GCF Repo cash obligation to FICC on an
intraday basis.\14\
---------------------------------------------------------------------------

    \13\ See Securities Exchange Act Release No. 34-57652 (April 11,
2008), 73 FR 20999 (April 17, 2008).
    \14\ NFE is a methodology that clearing banks use to determine
whether an account holder (such as a dealer) has sufficient
collateral to enter into a specific transaction. NFE allows the
clearing bank to place a limit on its customer's activity by
calculating a value on the customer's balances at the bank. Bank
customers have the ability to monitor their NFE balance throughout
the day.
---------------------------------------------------------------------------

    The 2007 NFE Filing replaced the Day 2 morning unwind process with
an alternate process, which is currently in effect. Specifically, in
lieu of making funds payments, the interbank dealers grant to FICC a
security interest in their NFE-related collateral equal to their
prorated share of the total interbank funds amount. FICC, in turn,
grants to the other clearing bank (that was due to receive the funds) a
security interest in the NFE-related collateral to support the debit in
the FICC account at the clearing bank. The debit in the FICC account
(``Interbank Cash Amount Debit'') occurs because the dealers who are
due to receive funds in the morning must receive those funds at that
time in return for their release of collateral. The debit in the FICC
account at the clearing bank gets satisfied during the end of day GCF
Repo settlement process. Specifically, that day's new activity yields a
new interbank funds amount that will move at end of day--however, this
amount gets netted with the amount that would have been due in the
morning, thus further reducing the interbank funds movement. The NFE
holds are released when the interbank funds movement is made at end of
day. The 2007 NFE Filing did not involve any changes to the after-hours
movement of securities occurring at the end of the day on Day 1.
    Using the example above:

    On the morning of Day 2, Dealer C who needs to return funds in
the unwind, instead of returning the funds in the morning, grants to
FICC a security interest in Dealer C's NFE-related collateral equal
to its funds movement (it is assumed only one GCF Repo transaction
took place in this simplified example). FICC, in turn, grants BNY
(that was due to receive the funds) a security interest in the NFE-
related collateral to support the debit in the FICC account at BNY.
As noted above, the debit in FICC's account at BNY arises because,
under the current processing, Dealer B must receive its funds during
the morning unwind. The FICC debit is then satisfied during the end
of day GCF Repo settlement process.

    As part of the 2007 NFE Filing, FICC imposed certain additional
risk management measures with respect to the GCF Repo service. First,
FICC imposed a collateral premium (``GCF Premium Charge'') on the GCF
Repo portion of the Clearing Fund deposits of all GCF participants to
further protect FICC in the event of an intra-day default of a GCF Repo
participant. FICC requires GCF Repo participants to submit a quarterly
``snapshot'' of their holdings by asset type to enable risk management
staff to determine the appropriate Clearing Fund premium. As with all
other instances of late submissions of required information, members
who do not submit this required information by the deadlines
established by FICC are subject to a fine and an increased Clearing
Fund premium.
    Second, the 2007 NFE Filing addressed the situation where FICC
becomes concerned about the volume of interbank GCF Repo activity. Such
a concern might arise, for example, if market events were to cause
dealers to turn to the GCF Repo service for increased funding at levels
beyond normal processing. The 2007 NFE Filing provides FICC with the
discretion to institute risk mitigation and appropriate disincentive
measures in order to bring GCF Repo levels to a comfortable level from
a risk management perspective.\15\
---------------------------------------------------------------------------

    \15\ Specifically, the 2007 NFE Filing introduced the term ``GCF
Repo Event,'' which will be declared by FICC if either of the
following occurs: (i) The GCF interbank funds amount exceeds five
times the average interbank funds amount over the previous ninety
days for three consecutive days; or (ii) the GCF interbank funds
amount exceeds fifty percent of the amount of GCF Repo collateral
pledged for three consecutive days. FICC reviews these figures on a
semi-annual basis to determine whether they remain adequate. FICC
also has the right to declare a GCF Repo Event in any other
circumstances where it is concerned about GCF Repo volumes and
believes it is necessary to declare a GCF Repo Event in order to
protect itself and its members. FICC will inform its members about
the declaration of the GCF Repo Event via important notice. FICC
will also inform the Commission about the declaration of the GCF
Repo Event.
---------------------------------------------------------------------------

Proposed Changes to the GCF Repo Service To Implement the TPR's
Recommendations
    FICC is proposing the following rule changes with respect to the
GCF Repo service to address the TPR's Recommendations:
    (1) (a) To move the Day 2 unwind from 7:30 a.m. to 3:30 p.m.; (b)
to move the NFE process \16\ from morning to a time established by FICC
as announced by notice to all members; \17\ (c) to move the cut-off
time of GCF Repo submissions from 3:35 p.m. to 3 p.m.; and (d) to move
the cut-off time for dealer affirmation or disaffirmation from 3:45
p.m. to 3 p.m.; and
---------------------------------------------------------------------------

    \16\ No other changes are being proposed to the NFE process that
was in place by the 2007 NFE Filing; the risk management measures
that were put in place by the 2007 NFE Filing remain in place with
the present proposal.
    \17\ The time range initially will be between 8 a.m. and 1 p.m.
---------------------------------------------------------------------------

    (2) To establish rules for intraday GCF Repo collateral
substitutions.\18\
---------------------------------------------------------------------------

    \18\ It should be noted that for interbank GCF Repo
transactions, the substitution process will initially only permit
cash substitutions, as discussed in more detail below.
---------------------------------------------------------------------------

(1) Proposed Change Regarding the Morning Unwind and Related Rule
Changes
    The TPR has recommended that the Day 2 unwind for all tri-party
transactions are moved from the morning to 3:30 p.m. The TPR has made
this recommendation in order to reduce the clearing banks' intraday
exposure to the dealers. As previously stated, because the GCF Repo
service is essentially a tri-party repo mechanism, FICC has also been
requested by the TPR to accommodate this time change. For the GSD
rules, this necessitates a change to the GSD's ``Schedule of GCF
Timeframes'' (``Schedule''). Specifically, the 7:30 a.m. time in the
Schedule will be deleted and the language therein proposed to be moved
to a new time of 3:30 p.m. on the Schedule.
    The change to the time of the intrabank unwind also necessitates a
change to the cut-off time for GCF Repo trade submissions, which is
currently 3:35 p.m. in the Schedule. FICC is proposing to amend the
Schedule to change the cut-off time to 3 p.m. to allow FICC to submit
files to the clearing banks which, in turn, will provide files to the
dealers by 3:30 p.m.; this will permit the dealers to have a complete
picture of their positions as the unwind occurs at 3:30 p.m. The 3:45
p.m. cutoff for dealer affirmation or disaffirmation that is in the
current Schedule will move to 3 p.m. so that the new 3 p.m. cutoff for
submissions will also now be the cutoff for dealer affirmations and
disaffirmations.\19\
---------------------------------------------------------------------------

    \19\ This change updates the current Schedule to provide that
the cutoff for submissions and dealer affirmations/disaffirmations
is at the same time; the current practice is inconsistent with the
current Schedule and the proposed rule change would remedy this
inconsistency.
---------------------------------------------------------------------------

    Because the Day 2 unwind is proposed to move from the morning to
3:30 p.m. and because the NFE process established by the 2007 NFE
Filing is tied to the moment of the interbank unwind, the NFE process
will also move

to the time established by FICC as announced by notice to all members.
This range will be between 8 a.m. and 1 p.m. Because the NFE process is
a legal process and not an operational process, it is not reflected on
the Schedule. A change is needed in Section 3 of Rule 20 to delete the
reference to the ``morning'' timeframe on Day 2 with respect to the NFE
process and to add language referencing ``at the time established by
the Corporation.''
(2) Proposed Change Regarding Intraday GCF Repo Securities Collateral
Substitutions
    As a result of the time change of the unwind (i.e., the reversal on
Day 2 of collateral allocations established by FICC for each netting
member's GCF net funds borrower positions and GCF net funds lender
positions on Day 1) to 3:30 p.m., the provider of GCF Repo securities
collateral in a GCF Repo transaction on Day 1 will no longer have
access to such securities at the beginning of Day 2. Therefore, during
Day 2 prior to the unwind of the Day 1 collateral allocations, the
provider of GCF Repo securities collateral (Dealer C, in the example)
needs a substitution mechanism for the return of its posted GCF Repo
securities collateral in order to make securities deliveries for
utilization of such securities in its business activities. (In the
example, Dealer C may need to return the securities to Party Y
depending upon the terms of their transaction). FICC is proposing to
establish a substitution process for this purpose in conjunction with
its clearing banks. The language for the substitution mechanism is
proposed to be added to Section 3 of GSD Rule 20. The proposed rule
change provides that all requests for substitution for the GCF Repo
securities collateral must be submitted by the provider of the GCF Repo
securities collateral (i.e., Dealer C) by the applicable deadline on
Day 2 (the ``substitution deadline'').\20\
---------------------------------------------------------------------------

    \20\ FICC will establish such deadline prior to the
implementation of the changes to this service in conjunction with
the clearing banks and the Federal Reserve in light of market
circumstances. The initial substitution deadline is anticipated to
be 1 p.m.; however, this will be finalized with the Federal Reserve
and the clearing banks. The time range will be between 8 a.m. and 1
p.m. FICC will provide members advanced notice of the substitution
deadline and any future changes thereto by important notice.
---------------------------------------------------------------------------

Substitutions on Intrabank GCF Repos
    If the GCF Repo transaction is between dealer counterparties
effecting the transaction through the same clearing bank (i.e., on an
intra-clearing bank basis and in our example Dealer C and other dealers
clearing at Chase), on Day 2 such clearing bank will process each
substitution request of the provider of GCF Repo securities collateral
(i.e., Dealer C) submitted prior to the substitution deadline promptly
upon receipt of such request. The return of the GCF Repo securities
collateral in exchange for cash and/or eligible securities of
equivalent value can be effected by simple debits and credits to the
accounts of the GCF Repo dealer counterparties at the clearing agent
bank (i.e., in the example, Chase). Eligible securities for this
purpose will be the same as those currently permitted under the GSD
rules for collateral allocations, namely, Comparable Securities,\21\
(ii) Other Acceptable Securities,\22\ or (iii) U.S. Treasury bills,
notes or bonds maturing in a time frame no greater than that of the
securities that have been traded (except where such traded securities
are U.S. Treasury bills, substitution may be with Comparable Securities
and/or cash only).
---------------------------------------------------------------------------

    \21\ The GSD rules define ``Comparable Securities'' as follows:
The term ``Comparable Securities'' means, with respect to a security
or securities that are represented by a particular Generic CUSIP
Number, any other security or securities that are represented by the
same Generic CUSIP Number.
    \22\ The GSD rules define ``Other Acceptable Securities'' as
follows: The term ``Other Acceptable Securities'' means, with
respect to: (An) adjustable-rate mortgage-backed security or
securities issued by Ginnie Mae, any fixed-rate mortgage-backed
security or securities issued by Ginnie Mae, or (an) adjustable-rate
mortgage-backed security or securities issued by either Fannie Mae
or Freddie Mac: (a) Any fixed-rate mortgage-backed security or
securities issued by Fannie Mae and Freddie Mac, (b) any fixed-rate
mortgage-backed security or securities issued by Ginnie Mae, or (c)
any adjustable-rate mortgage-backed security or securities issued by
Ginnie Mae.
---------------------------------------------------------------------------

Substitutions on Interbank GCF Repos
    For a GCF Repo that was processed on an interbank basis and to
accommodate a potential substitution request, FICC proposes to initiate
a debit of the securities in the account of the lender through the FICC
GCF Repo accounts at the clearing bank of the lender and the FICC GCF
Repo account at the clearing bank of the borrower (``Interbank
Movement''). This Interbank Movement is being done so that a borrower
who elects to substitute collateral will have access to the collateral
for which it is substituting. The Interbank Movement is expected to
occur in the morning, though the clearing banks and FICC have the
capability to have the Interbank Movement occur at any point during the
day up until 2:30 p.m. The agreed upon final timeframe will be
determined as between FICC and the clearing banks prior to the
implementation date of the Pilot Program. During the Pilot Program,
FICC and the clearing banks will unwind the intrabank GCF Repo
transactions at 3:30 p.m. FICC and the clearing banks will determine
the most appropriate timeframe for the Interbank Movement process to
occur.
    In the example above, the GCF Repo securities collateral will be
debited from the securities account of the receiver of the collateral
(i.e., Dealer B) at its clearing bank (i.e., BNY), and from the FICC
Account for BNY. If a substitution request is received by the clearing
bank (i.e., Chase) of the provider of GCF Repo securities collateral,
prior to the substitution deadline at a time specified in FICC's
procedures,\23\ that clearing bank will process the substitution
request by releasing the GCF Repo securities collateral from the FICC
GCF Repo account at Chase and crediting it to the account of the
provider of GCF Repo securities collateral (i.e., Dealer C). All cash
substituted for the GCF Repo securities collateral being released will
be credited to FICC's GCF Repo account at the clearing bank (i.e.,
Chase).
---------------------------------------------------------------------------

    \23\ This timeframe will also be established in consultation
with the clearing banks and the Federal Reserve. The parties are
considering whether to have the substitution process be accomplished
in two batches during the day depending upon the time of submission
of the notifications for substitution. In any event, substitution
requests will be subject to the substitution deadline. The details
of the batches, if applied, will be announced to members by
important notice. The deadline for submission of GCF Repo
substitution requests will be the same for intrabank and interbank
processing.
---------------------------------------------------------------------------

    Simultaneously, with the debit of the GCF Repo securities
collateral from the account at the clearing bank (i.e., BNY) of the
original receiver of GCF Repo securities collateral (i.e., Dealer B),
for purposes of making payment to the original receiver of securities
collateral (i.e., Dealer B), such clearing bank will effect a cash
debit equal to the value of the securities collateral in FICC's GCF
Repo account at such clearing bank and will credit the account of the
original receiver of securities collateral (i.e., Dealer B) at such
clearing bank with such cash amount. (This is because when Dealer B is
debited the securities, Dealer B must receive the funds.) In order to
secure FICC's obligation to repay the balance in FICC's GCF Repo
account at such clearing bank (i.e., BNY), FICC will grant to such
clearing bank a security interest in the cash substituted for the GCF
securities collateral in FICC's GCF repo account at the other clearing
bank (i.e., Chase).
    Using the example from above, assume the Dealer C submits a
substitution notification--it requires the securities collateral that
has been pledged to Dealer B and will substitute

cash. BNY will debit the securities from Dealer B's account and the
relevant liens will be released so that the securities are in FICC's
account at Chase. Chase will credit the securities to Dealer C's
account and the cash that Dealer C uses for its collateral substitution
will be credited by Chase to FICC's account at Chase. From Dealer B's
perspective, when BNY debits the securities from Dealer B's account,
Dealer B is supposed to receive the funds--but as noted, the funds are
at Chase. BNY will credit the funds to Dealer B's account and debit
FICC's account at BNY.
    At this point in the example, FICC is running a credit at Chase and
a debit at BNY. In order to secure FICC's debit at BNY, FICC will grant
a security interest in the funds in the FICC account at Chase.
    For substitutions that occur with respect to GCF Repo transactions
that were processed on an inter-clearing bank basis, FICC and the
clearing banks will initially only permit cash substitutions in order
to accommodate current processing systems. In the future, as systems
are upgraded, FICC may permit securities substitutions in the same way
as described above for GCF Repo transactions occurring on the intra-
clearing bank basis. The proposed rule change provides FICC with
flexibility in this regard by referring to FICC's procedures. If
interbank securities substitutions begin to be permitted, FICC will
announce this to members by important notice.
Other Rule Changes
    FICC is also proposing to make technical clean-up changes to
Section 7 of GSD Rule 20, which relate to the GCF Repo collateral
process. Specifically, a correction is being made to change references
to the defined term ``Security'' to ``security'' to conform to the use
of ``security'' throughout the rule. The proposed rule change also
introduces a term that previously had not been included in the rules
inadvertently, ``GCF Collateral Excess Account.'' This term is defined
in the proposed rule change as ``the account established by a GCF
Custodian Bank in the name of the Corporation to hold securities it
credits to the GCF Securities Account the Corporation establishes for
another GCF Clearing Bank.''
    (ii) FICC believes the proposed rule changes are consistent with
the requirements of Section 17A of the Act \24\ and the rules and
regulations thereunder applicable to FICC because the rule amendments
are designed to promote the prompt and accurate clearance and
settlement of security transactions and assure the safeguarding of
securities and funds which are in the custody or control of FICC by
aligning the GCF Repo service with recommendations being made by the
TPR to address risks in the overall tri-party repo market, which will
serve to safeguard the securities and funds for which FICC is
responsible. The proposed rule change is not inconsistent with the
existing rules of FICC, including any other rules proposed to be
amended.
---------------------------------------------------------------------------

    \24\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

(B) Self-Regulatory Organization's Statement on Burden on Competition

    FICC does not believe that the proposed rule change would impose
any burden on competition.

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

    Written comments relating to the proposed rule change have not been
solicited or received. FICC will notify the Commission of any written
comments received by FICC.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) As the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
(A) By order approve or disapprove the proposed rule change or (B)
Institute proceedings to determine whether the proposed rule change
should be disapproved.

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-FICC-2011-05 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FICC-2011-05. 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 Web site viewing and
printing 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 p.m. Copies of such filings will also be available for
inspection and copying at the principal office of FICC and on FICC's
Web site at http://www.dtcc.com/downloads/legal/rule_filings/2011/ficc/2011-05.pdf.
    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-FICC-2011-05
and should be submitted on or before August 19, 2011.

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\25\
---------------------------------------------------------------------------

    \25\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-19190 Filed 7-28-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Notices]
[Page 14129]
[FR Doc No: 2015-06206]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. P-2744-043]

N.E.W. Hydro, LLC; Notice of Technical Meeting

    Project Name and Number: Menominee/Park Mill Hydroelectric Project
No. 2744.
    Date and Time of Meeting: March 27, 2015; 10 a.m. Eastern Time (9
a.m. Central Time).
    Place: Telephone conference with N.E.W. Hydro, Inc.
    FERC Contact: Chelsea Hudock<EMAIL_ADDRESS>or (202) 502-
8448.
    Purpose of Meeting: To discuss the applicant's responses (filed on
April 2, 2014 and December 2, 2014) to the Commission's Additional
Information Requests filed on August 26, 2014 and December 31, 2013,
and other outstanding questions following the Commission's review of
the N.E.W. Hydro's application, filed on February 28, 2013.
    A summary of the meeting will be prepared and filed for the
project's records.
    All local, state, and Federal agencies, Indian tribes, and other
interested parties are invited to participate by phone. Please contact
Chelsea Hudock at<EMAIL_ADDRESS>or<PHONE_NUMBER> by close of
business March 17, 2015, to RSVP and to receive specific instructions
on how to participate.

    Dated: March 12, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-06206 Filed 3-17-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 220 (Thursday, November 14, 2019)]
[Notices]
[Pages 61913-61915]
[FR Doc No: 2019-24717]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2310]

Process To Request a Review of Food and Drug Administration's
Decision Not To Issue Certain Export Certificates for Devices; Guidance
for Industry and Food and Drug Administration Staff; 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 final guidance entitled ``Process to Request a
Review of FDA's Decision Not to Issue Certain Export Certificates for
Devices.'' FDA is issuing this guidance to comply with changes to the
Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA
Reauthorization Act of 2017 (FDARA), which specifies the process
afforded to persons denied a Certificate to Foreign Government (CFG)
for a device. This guidance describes the information that the Center
for Devices and Radiological Health (CDRH) and the Center for Biologics
Evaluation and Research (CBER), in collaboration with the Office of
Regulatory Affairs (ORA), will provide to a person whose request for a
CFG for a device is denied, and the process for seeking review of such
a denial.

DATES: The announcement of the guidance is published in the Federal
Register on November 14, 2019.

ADDRESSES: You may submit either electronic or written comments on

Agency guidances 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-2018-D-2310 for ``Process to Request a Review of FDA's Decision Not
to Issue Certain Export Certificates for Devices.'' 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.
     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.gpo.gov/fdsys/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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Process to Request a Review of FDA's Decision Not to Issue Certain
Export Certificates for Devices'' to the Office of Policy, Guidance and
Policy Development, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002, or to the Office of Communication,
Outreach and Development, Center for Biologics Evaluation and Research
(CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Joann Belt, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1463, Silver Spring, MD 20993-0002,
<EMAIL_ADDRESS>301-796-7400, option 3; or Stephen Ripley,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing this guidance to comply with section 704 of FDARA
(Pub. L. 115-52), which amended section 801(e)(4) of the FD&C Act (21
U.S.C. 381(e)(4)), to specify the process afforded to persons denied a
CFG for a device. This guidance describes the information that CDRH and
CBER, in collaboration with ORA, will provide to a person whose request
for a CFG for a device is denied, and the process for seeking review of
such a denial. This guidance applies to the process for persons denied
CFGs requested pursuant to section 801(e)(4)(A) of the FD&C Act for
devices manufactured in an establishment registered under section 510
of the FD&C Act (21 U.S.C. 360) (i.e., FDA-approved, cleared, or
exempted devices) that are exported from the United States. This
guidance supplements the FDA's guidance ``FDA Export Certificates,''
which is available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-export-certificates. FDA considered
comments received on the draft guidance that appeared in the Federal
Register of August 17, 2018 (83 FR 41078). FDA revised the guidance as
appropriate in response to the comments.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Process to Request a Review of FDA's
Decision Not to Issue Certain Export Certificates for Devices.'' 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.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all

Center for Devices and Radiological Health guidance documents is
available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov or
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Persons unable to
download an electronic copy of ``Process to Request a Review of FDA's
Decision Not to Issue Certain Export Certificates for Devices'' may
send an email request to<EMAIL_ADDRESS>to receive an
electronic copy of the document. Please use the document number 17044
to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:

------------------------------------------------------------------------
 FD&C Act section; 21 CFR part; or                          OMB control
             guidance                       Topic               No.
------------------------------------------------------------------------
FD&C Act sections 801(e) and 802    Export certificates        0910-0498
 (21 U.S.C. 382).                    for FDA regulated
                                     products.
21 CFR part 820...................  Current Good               0910-0073
                                     Manufacturing
                                     Practice (CGMP);
                                     Quality System (QS)
                                     Regulation.
21 CFR part 807, subparts A         Electronic                 0910-0625
 through E.                          Submission of
                                     Medical Device
                                     Registration and
                                     Listing.
``Center for Devices and            Appeals process.....       0910-0738
 Radiological Health Appeals
 Processes``.
------------------------------------------------------------------------

    Dated: November 5, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24717 Filed 11-13-19; 8:45 am]
 BILLING CODE 4164-01-P