From:    Robin Dunkins/RTP/USEPA/US

To<EMAIL_ADDRESS>
Cc:        Bill Schrock/RTP/USEPA/US@EPA, John
Bradfield/RTP/USEPA/US@EPA, Kelley Spence/RTP/USEPA/US@EPA, Karen
Thundiyil/DC/USEPA/US@EPA, Scott Jordan/DC/USEPA/US@EPA, Stan
Durkee/DC/USEPA/US@EPA, George Woodall/RTP/USEPA/US@EPA, Dave
Guinnup/RTP/USEPA/US@EPA, James Hirtz/RTP/USEPA/US@EPA, Sara
Ayres/DC/USEPA/US@EPA

Date:     12/13/2011 10:30 AM

Subject: Fw: Pulp and Paper RTR Package - Revisions in Response to
Interagency Comments

________________________________________

Cortney,

Here are the revisions based on interagency review and comments.  As
mentioned on our call yesterday, we also made a few edits.  We can
discuss further at noon today.

Thanks

robin

Robin Dunkins

Leader, Natural Resources Group

Office of Air Quality Planning and Standards

US Environmental Protection Agency  (C504-03)

(phone)<PHONE_NUMBER>   (fax) 919-541- 3470

<EMAIL_ADDRESS>


[Federal Register Volume 84, Number 24 (Tuesday, February 5, 2019)]
[Notices]
[Page 1813]
[FR Doc No: 2019-01185]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE:  2:00 p.m. on Thursday, February 7, 2019.

PLACE: The meeting will be held at the Commission's headquarters, 100 F
Street NE, Washington, DC 20549.

STATUS: This meeting will be closed to the public.

MATTERS TO BE CONSIDERED: Commissioners, Counsel to the Commissioners,
the Secretary to the Commission, and recording secretaries will attend
the closed meeting. Certain staff members who have an interest in the
matters also may be present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10),
permit consideration of the scheduled matters at the closed meeting.
    Commissioner Peirce, as duty officer, voted to consider the items
listed for the closed meeting in closed session.
    The subject matters of the closed meeting will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Resolution of litigation claims; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.

CONTACT PERSON FOR MORE INFORMATION:  For further information and to
ascertain what, if any, matters have been added, deleted or postponed;
please contact Brent J. Fields from the Office of the Secretary at
(202) 551-5400.

    Dated: January 31, 2019.
Brent J. Fields,
Secretary.
[FR Doc. 2019-01185 Filed 2-1-19; 11:15 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 250 (Thursday, December 29, 2011)]
[Notices]
[Pages 82006-82007]
[FR Doc No: 2011-33362]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66030; File No. SR-CME-2011-18]

Self-Regulatory Organizations; Chicago Mercantile Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Establish a Fee Schedule Applicable to Its OTC Credit Default Swap
North American Index Clearing Offering

December 22, 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 December 20, 2011, Chicago Mercantile Exchange Inc. (``CME'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change described in Items I, II and III below, which
items have been prepared primarily by CME. CME filed the proposed rule
change pursuant to

Section 19(b)(3)(A) \3\ of the Act and Rule 19b-4(f)(2) \4\ thereunder.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

    CME is proposing to establish a fee schedule applicable to its OTC
Credit Default Swap North American Index clearing offering. The text of
the proposed rule change is available at CME's Web site at http://www.cmegroup.com, at the principal office of CME, and at the
Commission's Public Reference Room.

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

    In its filing with the Commission, CME included statements
concerning the purpose 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. CME has prepared summaries, set forth in sections A, B,
and C below, of the most significant aspects of such statements.

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

    CME currently has in place a temporary fee waiver program that
applies to its OTC credit default swap index clearing business (the
``Waiver Program'').\5\ The Waiver Program is a general fee waiver that
applies equally to all market participants, including CDS Clearing
Members and their customers. The Program is set to expire on December
31, 2011.
---------------------------------------------------------------------------

    \5\ The Commission notes that the Waiver Program became
effective on October 17, 2011. See Exchange Act Release No. 65634
(October 26, 2011), 76 FR 67517 (November 1, 2011) (SR-CME-2011-11).
---------------------------------------------------------------------------

    The filing proposes to establish two new fee schedules that will
apply to CME's OTC Credit Default Swap North American Index clearing
fees. North American Index CDS Fee Schedule A is the default fee
schedule for all market participants clearing North American CDX Index
CDS products at CME Group. Market participants may alternatively elect
to participate in North American Index CDS Fee Schedule B (the ``Flat
Rate Fee Program''). The Flat Rate Fee Program features a single
blended flat rate for each transaction cleared and employs a look back
period to determine an implied average clearing fee and establish a
single blended flat rate in the subsequent period. The look-back period
for the Flat Rate Fee Program is semi-annual, based on a calendar year,
ending fifteen days prior to the beginning of the next six month
period.
    The proposed rules changes are related to fees and therefore will
become effective immediately.\6\ However, the Program will become
operative as of January 1, 2012. The text of the proposed rule
amendments is available on CME's Web site, as noted above.
---------------------------------------------------------------------------

    \6\ The staff notes that pursuant to 15 U.S.C. 78s(b)(3)(A)(ii)
rule changes related to fees are effective upon filing.
---------------------------------------------------------------------------

    CME has also certified the proposed rule changes that are the
subject of this filing to its primary regulator, the Commodity Futures
Trading Commission (``CFTC'').

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

    CME does not believe that the proposed rule change will have any
impact, or impose any burden, on competition.

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

    CME has not solicited, and does not intend to solicit, comments
regarding this proposed rule change. CME has not received any
unsolicited written comments from interested parties.

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

    The foregoing rule change was filed pursuant to Section 19(b)(3)(A)
of the Act and paragraph (f)(2) of Rule 19b-4 and became effective on
filing. At any time within sixty days of the filing of such rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

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 may be submitted by using the
Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml), or send an email to<EMAIL_ADDRESS>Please include
File No. SR-CME-2011-18 on the subject line.
     Paper comments should be sent 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-CME-2011-18. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of CME. 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-CME-2011-18 and
should be submitted on or before January 19, 2012.

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-33362 Filed 12-28-11; 8:45 am]
BILLING CODE 8011-01-P


	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Part 52

	[EPA-R03-OAR-2007-1188; FRL-         ]

Approval and Promulgation of Air Quality Implementation Plans; Delaware;

Control of Stationary Generator Emissions

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

SUMMARY:  EPA is approving a State Implementation Plan (SIP) revision
submitted by the State of Delaware.  This SIP revision contains
provisions to control emissions from stationary generators.  EPA is
approving this SIP revision in accordance with the Clean Air Act (CAA).

EFFECTIVE DATE:  This final rule is effective on [insert date 30 days
from date of publication].

ADDRESSES:  EPA has established a docket for this action under Docket
ID Number EPA-R03-OAR-2007-1188.  All documents in the docket are listed
in the www.regulations.gov website.  Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information (CBI) or other information whose disclosure is
restricted by statute.  Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form.  Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103.  Copies of the State
submittal are available at the Delaware Department of Natural Resources
& Environmental Control, 89 Kings Highway, P.O. Box 1401, Dover,
Delaware 19903.

FOR FURTHER INFORMATION CONTACT:  Rose Quinto,<PHONE_NUMBER>, or by
e-mail at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

SUPPLEMENTARY INFORMATION:

I.  Background

On March 5, 2008 (73 FR 11845), EPA published a notice of proposed
rulemaking (NPR) for the State of Delaware.  The NPR proposed approval
of the provisions to control emissions from stationary generators.  The
formal SIP revision was submitted by the State of Delaware on November
1, 2007.  Specific requirements of Delaware’s regulation to control
emissions from stationary generators and the rationale for EPA's
proposed action are explained in the NPR and will not be restated here.
No public comments were received on the NPR.

II.  Final Action

EPA is approving Regulation No. 1144 – Control of Stationary Generator
Emissions, as a revision to the Delaware SIP.  This regulation will help
ensure that the air emissions from new and existing generators do not
cause or contribute to the existing air quality problems with regard to
ground-level ozone and fine particulate matter, thereby adversely
impacting public health, safety, and welfare.

III.  Statutory and Executive Order Reviews

A.  General Requirements

Under the CAA, the Administrator is required to approve a SIP submission
that complies with

the provisions of the CAA and applicable Federal regulations.  42 U.S.C.
7410(k); 40 CFR 52.02(a).  Thus, in reviewing SIP submissions, EPA’s
role is to approve state choices, provided that they meet the criteria
of the CAA.  Accordingly, this action merely approves state law as
meeting Federal requirements and does not impose additional requirements
beyond those imposed by state law.  For that reason, this action:

is not a "significant regulatory action” subject to review by the
Office of Management and Budget under Executive Order 12866 (58 FR
51735, October 4, 1993);

does not impose an information collection burden under the provisions of
the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

is certified as not having a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.);

does not contain any unfunded mandate or significantly or uniquely
affect small governments, as described in the Unfunded Mandates Reform
Act of 1995 (Public Law 104-4);

does not have Federalism implications as specified in Executive Order
13132 (64 FR 43255, August 10, 1999);

is not an economically significant regulatory action based on health or
safety risks subject to Executive Order 13045 (62 FR 19885, April 23,
1997);

is not a significant regulatory action subject to Executive Order 13211
(66 FR 28355, May 22, 2001);

is not subject to requirements of Section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note)
because application of those requirements would be inconsistent with the
CAA; and

does not provide EPA with the discretionary authority to address, as
appropriate, disproportionate human health or environmental effects,
using practicable and legally permissible methods, under Executive Order
12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP
is not approved to apply in Indian country located in the state, and EPA
notes that it will not impose substantial direct costs on tribal
governments or preempt tribal law.

B.  Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating the
rule must submit a rule report, which includes a copy of the rule, to
each House of the Congress and to the Comptroller General of the United
States.  EPA will submit a report containing this action and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register.  A major rule cannot
take effect until 60 days after it is published in the Federal Register.
 This action is not a “major rule” as defined by 5 U.S.C. 804(2).

C.  Petitions for Judicial Review

Under section 307(b)(1) of the CAA, petitions for judicial review of
this action must be filed in the United States Court of Appeals for the
appropriate circuit by [insert date 60 days from date of publication of
this document in the Federal Register].  Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purposes of judicial review nor does
it extend the time within which a petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
This action, pertaining to Delaware’s regulation to control emissions
from stationary generators, may not be challenged later in proceedings
to enforce its requirements.  (See section 307(b)(2).)

List of Subjects in 40 CFR part 52

Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Nitrogen dioxide, Ozone, Particulate matter,
Reporting and recordkeeping requirements, Sulfur oxides.

__April 15, 2008____
__________/s/_________________

Dated:   		  				William T. Wisniewski, Acting
 							Regional Administrator,

                                  					Region III.

40 CFR part 52 is amended as follows:

PART 52 - [AMENDED]

1.  The authority citation for part 52 continues to read as follows:

               Authority:  42 U.S.C. 7401 et seq.

Subpart I ( Delaware

2.  In ( 52.420, the table in paragraph (c) is amended by adding entries
for Regulation No. 1144 – Control of Stationary Generators Emissions
at the end of the table to read as follows:

( 52.420  		Identification of plan.

*		*		*		*		*

(c)  *   *   *

EPA-APPROVED REGULATIONS IN THE DELAWARE SIP

State citation	Title/subject	State effective date	EPA approval date
Additional explanation

         *            *               *              *              *
             *             *

Regulation No. 1144	Control of Stationary Generator Emissions

Section 1.0	General	01/11/06	[Insert Federal Register publication date]

[Insert page number where the document begins]

Section 2.0	Definitions	01/11/06	[Insert Federal Register publication
date]

[Insert page number where the document begins]

	Section 3.0	Emissions	01/11/06	[Insert Federal Register publication
date]

[Insert page number where the document begins]

	Section 4.0	Operating Requirements	01/11/06	[Insert Federal Register
publication date]

[Insert page number where the document begins]

	Section 5.0	Fuel Requirements	01/11/06	[Insert Federal Register
publication date]

[Insert page number where the document begins]

	Section 6.0	Record

Keeping and Reporting	01/11/06	[Insert Federal Register publication
date]

[Insert page number where the document begins]

	Section 7.0	Emissions Certification, Compliance, and Enforcement
01/11/06	[Insert Federal Register publication date]

[Insert page number where the document begins]

	Section 8.0	Credit for Concurrent Emissions Reductions	01/11/06	[Insert
Federal Register publication date]

[Insert page number where the document begins]

	Section 9.0	DVFA Member Companies	01/11/06	[Insert Federal Register
publication date]

[Insert page number where the document begins]

	*	*	*	*	*

 PAGE  5


failure rate and no adverse reactivity without
infectious agents or autoimmune conditions.
And our program has been partnered in part
with a grant of the National Heart Lung and Blood
Institute.
Thank you.
(Applause.)
DR. BISWAS:  Thank you very much.  We'll
now hear from Susan Stramer, Director of Labs at
American Red Cross, Gaithersburg, Maryland.
DR. STRAMER:  Thank you.  Before going
through the American Red Cross experience with NAT, what
the major users -- that includes myself, Sally Caglioti

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of BSI and Mike Strong of Puget Sound, we got together
and decided we needed standardization.  So the three of
us developed what I call a first generation list of
definitions, so that in going through the blood banking
experience with NAT, we report data uniformly and I
would like to go through those definitions and Sally and
myself pretty much adhere to them.  Mike will take
another generation to meet the requirements of the
definitions.
Okay, firstly, we'd like to define a yield
sample which is a seronegative donation that is
confirmed positive.  Let me just say before I go
further, I do have handouts of the definitions that I
will make available at the back of the room.  Anyway, so
moving from a yield sample which is really the purpose
of our study to identify seronegative donations, we move
into what is a confirmed positive result and those are
termed confirmed positives by three different
definitions.  One, positivity by a supplemental NAT
assay.  In the case of the Red Cross, we're using PCR.
Two, positivity on an alternate sample that is plasma
and the positivity can be the primary NAT, an alternate
NAT and serology or positivity on a follow-up sample.
Next.  We define an initially reactive

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result as a result that doesn't repeat.  For example, a
pool that is reactive that cannot be resolved to
individual donations.  We define a repeatedly reactive
result as a pool that is reactive that does resolve into
one single donation or a pool that does retest is
reactive.
Next.  We define a repeatedly reactive
unresolved pool of result as a pool that is initially
reactive.  The pool then resolves, but we cannot
identify a single reactive donation.
Getting more complicated, we have a
repeatedly reactive nondiscriminated donation and that
is a repeatedly reactive result that is one that
resolves to a single donation and this applies to the
Gen-Probe users with the use of the discriminatory
reagents.  We cannot identify that multiplex reactivity
as either HIV or HCV.
And lastly, we have a donation that was
reactive in a pool, reactive as a single specimen and
did discriminate by the discriminatory Gen-Probe
reagents.  However, we cannot -- we do not have any
corroborating positivity that is by the alternate NAT
assay, an alternate sample or follow-up.  Now you will
see how all of these fit into a presentation of

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specificity where specificity for a pool is defined as
a negative pool result or all the negative pool tests
divided by the negative pools tests plus the false
positives.  You can apply the same principle to
individual donation specificity.  And I will show you
results for both.
We also will report on test failures.  A
test failure as Christina Giachetti described for the
Gen-Probe assay can be an internal control failure.  It
can be assay calibrator failures or it can be failure of
the user to follow the manufacturer's product insert.
We also run external run controls so we
also can have an external run control failure; that is,
where the external run control does not meet expected
specifications.  However, the results from the
calibrator standpoint or the assay itself are valid.
Now to run through this with the Red Cross
NAT program, we are using the Gen-Probe Multiplex assay
plus discriminatory reagents.  We implemented on March
3rd of 1999 in phases which I will go through.  The
entire Red Cross system began testing then by June 7th.
Each of our assays, assay batches, contains the kit
calibrators as defined and four external controls: an
HIV, HCV negative and one used to demonstrate that p24

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antigen testing may not be necessary.
Phase 1 program and Phase 2 programs for
this presentation, what's important is pool size and the
difference in seroreactive testing.  For our Phase 1
program, we tested pool sizes of 128.  For our pre-Phase
2 program, let me call it that to avoid confusion, pre-
Phase 2, we test pools of 16.  The other difference
that's important for this talk is seroreactives were not
included in the 128 program, but seroreactives are
included for the pools of 16.
Next.  Okay, the pooling algorithm for
Phase 1 stretched to a pool size of 128.  Resolution,
again, following the definitions, we repeat.  Instead of
retesting pool, we test the component primary pools.  If
a pool is reactive, we test the individual donations.
The results of our Phase 1 program included
about 2.4 million donations tested.  We identified by
definition ten confirmed positive donations.  However,
three of these must be excluded for our yield definition
because when we went back and tested the alternate
sample, we found them antibody positive.  What does this
mean?  This means that we detected a test error in our
primary antibody screening as Dr. Busch referred to
earlier.

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So our adjusted yield for our Phase 1
program of 2.4 million donations was 1 in 334,043 for
HCV and we detected zero for HIV.  Our internal control
failures were actually a log lower than Christina
Giachetti reported.  We had 3.4 percent invalid runs.
An initial reactive rate of .14 percent.  That is
reactive pools that did not resolve.
Next.  Going to our pre-Phase 2 program,
we're creating pools of 16 resolution.  You take the
reactive pool and just dissect out the donations.  To go
through the data, we've tested 1.6 million plus
donations in over 100,000 pools.  We've had 231 reactive
pools that divide into 172 results that were not
reproducible, that is, did not resolve to single
donation and were termed initially reactive.  That's a
rate of .17 percent.  The product resulting from an
initial reactive pool is released.  We had 59 repeat
reactive individual donation samples, those that
resolved from reactive pools.
Next please.  Of those 59 repeat reactive
seronegative donations and it's important to say in
these algorithms I've excluded the seropositives.  Those
I will include in another summary slide.  This is only
dealing with yield samples.  So of the 59 repeat

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reactive single donations -- seronegative donations,
they divided into 30 that were HCV discriminated using
discriminatory reagent, 2 HIVs based on discriminatory
testing, six in which discriminatory testing could not
be completed because the sample volume was depleted and
21 results that were -- even though we had a single
donation identified by the Multiplex test, both
discriminatory tests were nonreactive.  Of these two
categories here, what's important is these 30 resolved
into five HCV yield samples and these two resolved into
1 HCV yield sample.
Next.  The 59 on the HCV arm, just to look
at these specifically, of the 30 that discriminated by
the discriminatory reagents, 14 were confirmed by
supplemental NAT.  But I just want to say supplemental
NAT may not always be the gold standard because of
potential source two contamination.  For example, in
nine of these they actually had to be reinterpreted as
negative because plasma was negative by NAT and
alternate NAT and follow up could not corroborate the
results.  But in five cases, we did have very high titer
viremia by the supplemental NAT test.  Plasma was
reactive and we had follow up.  So this translates into
our yield of 1 in 321,912 which is very comparable to

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the Phase 1 study.
Next.  For HIV, we had two HIV reactive
donations, interestingly enough, both confirmed by our
supplemental NAT test.  However, one was a source 2
contamination, that is, the plasma was negative and
follow up was negative at seven and 12 days.  However,
we did have one that was -- will be probably be a high
titer viremia sample although I don't have the
quantitative PCR results back yet, but at follow-up Day
7, the NAT result reproduced.  So for our Phase 2 study,
we have a yield of 1 in 1.6 million donations.
Next.  Interestingly enough, discriminatory
QNS and nondiscriminated tests, all of the ones that we
have supplemental information for did not show any
evidence of being NAT positive, so the NAT result could
not be reproduced.
Next.  So to summarize all the data I've
shown you for our two programs looking at seronegatives,
the first program, screened 2.4 million donations, the
second one, 1.6 million donations.  Numbers of pools,
you can see quite a few.  A higher number of pools than
our pre-Phase 2 study since we're testing a smaller pool
size.  Initial reactive rates were comparable, .14, .17.
Our yield for HCV, 1 in 331,000 for Phase 1.  1 in

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321,000 for Phase 2.  Our HIV yield, we only had one in
the Phase 2 for 1 in 1.6 million donations or if you
look at the entire program, that's one in about four
million donations for HIV.
Next.  If you look at the sum of all the
false positive categories that I went through, actually,
our Phase 1 study was perfect in terms of false
positives.  We had zero that resolved to single
donations that weren't confirmed, but we had 53 in our
Phase 2 or a relatively low repeat reactive rate of 1 in
30,372.  That's lower than any serological test that we
do actually.  However, going from Phase 1 to our pre-
Phase 2 study, our positive predictive value dropped
from 100 percent to 8.5 percent.  Specificity has been
good, but decreased a little for pre-Phase 2 and our
single donation specificity actually for Phase 1 was 100
percent and just under 100 percent considering these 53
that resolved to single donation.
Next.  Looking at test failures, number of
invalid assay runs, 3.4 percent as I said for Phase 1;
six percent for pre-Phase 2.  This includes our external
run control failures which have been pretty consistent
at about 1.3 percent.  Internal control failures, again,
for both phases of the study very low, although a little

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bit lower in our pre-Phase 2.
Next.  Looking at the ten positives that we
got out of the Phase 1 study, including the three that
were antibody positive, just to show you the total data,
all ten were confirmed by alternate NAT.  We have
follow-up on 70 percent of the samples.  Consistency
among the way the TMA assay runs, whether it's in a
different pool size or it's the individual donation,
always runs about 9.  Discriminatory reagents run a
little bit higher.  Our viral load range from 180,000 to
59 million.  Actually now, I think we have one at 72
million copies per mL and an index donation and we've
seen all genotypes.
Next.  Just looking at the S to COs of
false positive, they cover the entire gamut of the
dynamic range of the assay, but most of them do cluster
at relatively low S to COs.
Next, please.  Now, if we look at all the
seroreactive results we've had to date, excuse me, not
to date, in the first month of our phase, pre-Phase 2
study, we looked at about a thousand samples.
Interestingly enough, NAT really compares well with the
supplemental tests that we do.  If we look at HIV
against NAT positivity, we see about six percent

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positive.  That's about the same rate we see to confirm
by Western blot, so NAT and Western blot perform very
comparably.  If we look at NAT relatively to HCV
antibody, we see really the same expectation.  If we
look at RIBA positives for HCV, we see about 60 to 65
percent.  If you back out those, it should represent
resolved infection or be negative for RNA.  You would
expect about a 45 percent repeat reactives that would be
NAT positive.  And that's exactly what we see.  If you
look at the unexpected findings, those I've put in gold.
Here we've had some NAT negative repeat reactive
Western blot positive individuals for HIV, but both of
these fall into the traditional category of patterns
that don't represent true infection, that is, a pattern
of GP-41, GP-120/160 and both of those have that
pattern, so we believe that these are probably false
positive results.
Conversely, we've had some NAT false
positive results in antibody repeat reactives and those
are represented here.  Similarly, for HCV, we've had
some NAT false positives, but certainly, in this
category, we've had both NAT -- excuse me, antibody
false positives and this category again represents
resolved infection.  Those are RIBA positives.

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Next, please.  And again, this just shows
you the S to CO distributions of seroreactive, either on
NAT negatives which are obviously less than one on an S
to CO with a NAT test.  These are the S to CO values
again clustered around nine for HCV and for HIV, we have
some very high values.  These values down here represent
what we believe are false positives on the test.
Thank you.
(Applause.)
DR. BISWAS:  Thank you very much, Susan.
Next speaker is Susan Caglioti, speaking for -- I'm
sorry, Sally Caglioti for America's Blood Centers from
BSI, Scottsdale, Arizona.
DR. CAGLIOTI:  Thank you.  I will be
reporting today on the experience that we've had using
the higher arm Chiron Gen-Probe, a TMI assay that's been
described in the America's Blood Center Study.
First slide, please.  There are three
investigators in our program:  our laboratory at Blood
Systems, the Blood Center of Southeastern Wisconsin,
Florida Blood Services.  We have a total of 56
sub-investigators that send samples to us for testing.
Through the end of November, we've tested about 1.4
million donations.

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Next slide.  This is just a summary of our
test algorithm which shows -- most of the samples that
I'll be discussing have been tested in parallel with
serology, i.e., serologic results are not known at the
time of the sample testing.  Test in 24 member pools.
Any reactives are resolved to individual samples with
a repeat of the pool times two.  Any individual
reactives are tested by both the discriminatory assays
described by Dr. Giachetti and then any discriminatory
positives are tested with the original in it and an
alternate sample, if available, by supplemental NAT and
by follow up.
Next slide.  This just shows our yield for
the first several, first nine months of the study.
We've tested, as I said, about 1.4 donations.  We've
seen four confirmed HCV positives for a rate of about 1
in 340,000 and two cases of HIV for a rate of about
101,000 and 678,000.
This is a summary of the HCV positive cases
which we've had four.  They're all young Caucasian
females.  Three of the four have been repeat donors.
Risk factors, you can see here are one had recently had
a body piercing, as well as a dialysis tech.  This one
has a sexual partner, IV drug user.  This denies any

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risk factor at all and this person has a seropositive.
You can see the viral modes are pretty consistent with
the exception of this one.  And time to seroconversion
has been in the range of 32 to 48 days.
These two cases are HIV NAT confirmed
positive, seronegative cases.  Both are 22 year old
black males.  One was a repeat donor and previous
donation was in 1993, a directed donor only.  All risk
factors denied here.  Lower viral load.  This person
claimed to have a homosexual experience two weeks prior
to the donation.
Time to follow up for p24 in
this case was six days.  To antibody positivity was 16
days.  This donor would return for follow up in ten
days, had both p24 and antibody reactivity.
Next slide.  The next couple of slides show
comparison of serology with NAT data.  This one is
Western blot.  As you can see, we had in this time frame
303 HIV EIA repeat reactive donations.  The data in the
next several slides are just from our organization and
blood systems donations and all of the centers for whom
we test.  We had 16 positive Western blots, 15 of which
were NAT positive.  I'll mention that this one donor
that was negative in the pool was positive in a single
donor setting.  The indeterminants here, much like Sue's

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were all cases where they were not normal patterns, all
nonviral bands only on the Western blot.
Next slide will show the RIBA results that
you can see.  We had 463 samples from a little over a
1,000 HCV repeat reactive donors in this time frame.
Eighty-two percent of the total positive RIBAs were
positive by NAT.  One hundred five negative by NAT.  Of
these 105, we looked at 60 and tested them by -- in a
single donation setting.  These were all pools.  And
about 25 percent of those were positive by single
donation testing.  These indeterminants of which there
were eight RIBA positive, we have indeterminant NAT
positive.  Two of them, the only reason that they were
considered indeterminant is because they had very
strongly positive SOD bands which by package insert,
even though the four HCV bands were there, would be
considered indeterminant.  Three of them were four plus
C22; two were C33, and one was an NS5.
Next slide.  Now I'll go through the
algorithms that Sue went through or similar algorithms
and show you what our specificity looks like.  We've
tested about 30,000 pools of which 607 were reactive for
a reactive rate of about two percent.  Repeat reactive,
remember that we do repeat test our pools,  we have 594.

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If you take these pools and break them down into the
individual donations, of these 594, 531 of these pools
had an individual that was positive by both multiplex
and discriminatory or 89 percent.  Four had no single
reactive donors and 59 had donors who were reactive by
the multiplex assay, but not by the discriminatory
assay.  So as far as looking at false positives, this
group, this group and this group would all be considered
false positives.
Next slide.  Looking at those tested as
single donations because in our setting if we don't have
enough samples to test a 24 member pool at the end of
the day, we test individuals samples.  We tested about
a little over 7500 donations.  We found 114 positive,
about 1.5 percent.  Of these, 92 or 80 percent were
positive by the discriminatory assay, here representing
the false positive group would be these 22 which did not
discriminate to a positive.
Next slide.  Of the 594 reactive pools, we
broke those down into the individual samples, a little
over 14,000 samples, 828 of which were multiplex
reactive.  Of those 635 discriminated by either HCV or
HIV.  One hundred fifty-nine were nonreactive, 34 QNS.
Again, these 159 would be considered false positives.

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Next slide, please.  Looking at those


[Federal Register Volume 86, Number 178 (Friday, September 17, 2021)]
[Notices]
[Pages 51898-51900]
[FR Doc No: 2021-20064]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Guidances for Ferric Oxyhydroxide; Revised Draft
Guidances for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of revised draft guidances for industry entitled
``Draft Guidance for Ferric Oxyhydroxide.'' The revised draft
guidances, when finalized, will provide product-specific
recommendations on, among other things, the design of bioequivalence
(BE) studies to support abbreviated new drug applications (ANDAs) for
ferric oxyhydroxide oral tablets (previously sucroferric oxyhydroxide)
and ferric oxyhydroxide intravenous injectable (previously iron
sucrose).

DATES: Submit either electronic or written comments on the draft
guidances by November 16, 2021 to ensure that the Agency considers your
comment on these draft guidances before it begins work on the final
versions of the guidances.

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-2007-D-0369 for ``Draft Guidance for Ferric Oxyhydroxide.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Christine Le, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002, 301-
796-2398 and/or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products,'' which
explained the process that would be used to make product-specific
guidances available to the public on FDA's website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.
    As described in that guidance, FDA adopted this process to develop
and disseminate product-specific guidances and to provide a meaningful
opportunity for the public to consider and comment on the guidances.
This notice announces the availability of revised draft guidances on
ferric oxyhydroxide oral tablets and ferric oxyhydroxide intravenous
injectable.
    FDA initially approved new drug application (NDA) 205109 VELPHORO
in November 2013 and NDA 021135 VENOFER in November 2000.\1\ In March
2015, FDA issued a draft product specific guidance for industry on
generic ferric oxyhydroxide oral tablets (previously entitled ``Draft
Guidance for Sucroferric Oxyhydroxide'') and in November 2013, FDA
issued a draft product specific guidance for industry on generic ferric
oxyhydroxide intravenous injectable (previously entitled ``Draft
Guidance for Iron Sucrose''). We are now issuing revised draft
guidances for industry on generic ferric oxyhydroxide oral tablets and
ferric oxyhydroxide intravenous injectable.
---------------------------------------------------------------------------

    \1\ The active ingredients were previously identified as
sucroferric oxyhydroxide and iron sucrose, respectively, at the time
of approval of these NDAs. FDA later concluded that the active
ingredient in both of these products is ferric oxyhydroxide. See
Letter to Areta Kupchyk, Foley Hoag LLP, from Patrizia Cavazzoni,
M.D., Acting Director, Center for Drug Evaluation and Research,
Docket No. 2016-P-1163 (May 26, 2021).
---------------------------------------------------------------------------

    In August 2021, Sidley Austin LLP submitted a citizen petition
requesting that FDA take several actions, including refraining from
changing the product label or labeling for VENOFER, any action to
modify the existing product-specific guidance for VENOFER, and any
action to change the established name of VENOFER to ferric oxyhydroxide
(Docket No. FDA-2021-P-0893). FDA is reviewing the issues raised in the
petition and will consider any comments on the draft guidances entitled
``Draft Guidance for Ferric Oxyhydroxide'' before responding to the
petition. FDA's issuance of the draft guidances on generic ferric
oxyhydroxide oral tablets and ferric oxyhydroxide intravenous
injectable does not represent a final decision on the issues raised in
the petition.
    The revised draft guidances are being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The revised draft
guidances, when finalized, will represent the current thinking of FDA
on the design of BE studies to support ANDAs for ferric oxyhydroxide.
They do not establish any rights for any person and are 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

    FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

III. Electronic Access

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

    Dated: September 13, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-20064 Filed 9-16-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 241 (Friday, December 16, 2022)]
[Notices]
[Page 77152]
[FR Doc No: 2022-27266]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 34771; File No. 812-15339]

Silver Spike Investment Corp., et al.

December 12, 2022.
AGENCY: Securities and Exchange Commission (``Commission'' or ``SEC'').

ACTION:  Notice.

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    Notice of application for an order under sections 17(d) and 57(i)
of the Investment Company Act of 1940 (the ``Act'') and rule 17d-1
under the Act to permit certain joint transactions otherwise prohibited
by sections 17(d) and 57(a)(4) of the Act and rule 17d-1 under the Act.

Summary of Application: Applicants request an order to permit certain
business development companies (``BDCs'') and closed-end management
investment companies to co-invest in portfolio companies with each
other and with certain affiliated investment entities.

Applicants: Silver Spike Investment Corp., Silver Spike Capital, LLC,
and Silver Spike Private Credit II, LP.

Filing Dates: The application was filed on May 19, 2022, and amended on
October 7, 2022 and December 9, 2022.

Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing on any application by emailing
the SEC's Secretary at [email protected] and serving the
Applicants with a copy of the request by email, if an email address is
listed for the relevant Applicant below, or personally or by mail, if a
physical address is listed for the relevant Applicant below. Hearing
requests should be received by the Commission by 5:30 p.m. on January
6, 2023, and should be accompanied by proof of service on the
Applicants, in the form of an affidavit or, for lawyers, a certificate
of service. Pursuant to rule 0-5 under the Act, hearing requests should
state the nature of the writer's interest, any facts bearing upon the
desirability of a hearing on the matter, the reason for the request,
and the issues contested. Persons who wish to be notified of a hearing
may request notification by emailing the Commission's Secretary at
[email protected].

ADDRESSES: The Commission: [email protected]. Applicants:
[email protected] and [email protected].

FOR FURTHER INFORMATION CONTACT: Barbara T. Heussler, Senior Counsel,
or Lisa Reid Ragen, Branch Chief, at<PHONE_NUMBER> (Division of
Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: For Applicants' representations, legal
analysis, and conditions, please refer to Applicants' second amended
and restated application, dated December 9, 2022, which may be obtained
via the Commission's website by searching for the file number at the
top of this document, or for an Applicant using the Company name search
field, on the SEC's EDGAR system. The SEC's EDGAR system may be
searched at, http://www.sec.gov/edgar/searchedgar/legacy/companysearch.html. You may also call the SEC's Public Reference Room
at<PHONE_NUMBER>.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2022-27266 Filed 12-15-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 46 (Friday, March 8, 2013)]
[Notices]
[Pages 15086-15087]
[FR Doc No: 2013-05414]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69028; File No. SR-NASDAQ-2013-035]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
To Assess a Fee for the Limit Locator Service

March 4, 2013.
    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 February 21, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') a proposed rule change as described in Items I, II and
III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    NASDAQ proposes to assess a fee for the Limit Locator service under
Rule 7061. NASDAQ will begin assessing the proposed fee on April 8,
2013.
    The text of the proposed rule change is below. Proposed new
language is in italics; proposed deletions are in brackets.

7061. Limit Locator

    Limit Locator is a tool to assist a member firm in monitoring its
trades reported into the FINRA/NASDAQ TRF for compliance with the
requirements of the National Market System Plan to Address
Extraordinary Market Volatility. The service provides a subscribing
member firm with an overview of its trades reported at, or outside of,
a designated Limit Up/Limit Down pricing band. The service will provide
a total count of the subscribing member firm's trades in each category
as well as present this information graphically, on a rolling month
basis. A subscribing member firm is able to create custom email alerts
to notify users when a trade is reported at, or outside of, a Limit Up/
Limit Down pricing band. Limit Locator is accessed through the NASDAQ
Workstation or Weblink ACT 2.0 and is offered for a fee of $750 per
month/per MPID beginning April 8, 2013 [at no cost at this time].
* * * * *

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

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

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

1. Purpose
    NASDAQ is proposing to amend Rule 7061 to establish fees for the
Limit Locator service. Limit Locator is an add on tool to the NASDAQ
Workstation and Weblink ACT 2.0 that assists a member firm that is a
FINRA/NASDAQ TRF (``TRF'') participant in monitoring its trades
reported into the TRF for compliance with the requirements of the
National Market System Plan to Address Extraordinary Market Volatility
(the ``Plan'').\3\ The Plan provides a limit up/limit down mechanism
designed to prevent trades in NMS securities from occurring outside of
specified price bands. Limit Locator assists member firms in complying
with the Plan by tracking trades reported to the TRF that occur at, or
outside of, the limit up/limit down bands and providing notice
thereof.\4\
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    \3\ On April 5, 2011, the Exchange, together with other self-
regulatory organizations, filed with the Commission a national
market system plan to adopt a market-wide limit up/limit down system
to reduce the negative impacts of sudden, unanticipated price
movements in NMS Stocks, like that which was experienced on May 6,
2010. Securities Exchange Act Release No. 64547 (May 25, 2011), 76
FR 31647 (June 1, 2011) (File No. 4-631). The Plan was approved by
the Commission on May 31, 2012. Securities Exchange Act Release No.
67091 (May 31, 2012), 77 FR 33498 (June 6, 2012).
    \4\ The Commission notes that every member firm has obligations
under the Plan to establish, maintain, and enforce written policies
and procedures that are reasonably designed to comply with the limit
up/limit down and trading pause requirements. Use of Limit Locator
may assist a member firm in complying with these requirements, but
use of Limit Locator alone does not satisfy a member firm's
obligation under the plan. See Securities Exchange Act Release No.
68841 (February 6, 2013), 78 FR 9966 (February 12, 2013) (SR-NASDAQ-
2013-020) footnote 4.
---------------------------------------------------------------------------

    NASDAQ implemented Limit Locator on February 4, 2013 \5\ at no cost
so that member firms could become familiar with the service using the
test securities of the Plan.\6\ Phase I of the Plan will be implemented
on April 8, 2013 and will apply the limit up/limit down bands only to
Tier 1 NMS Stocks, which are defined as all NMS Stocks included in the
S&P 500 Index, the Russell 1000 Index, and a list of exchange-traded
products. Accordingly, NASDAQ is proposing to offer the service for a
monthly fee of $750 per member MPID concurrent with the Phase I

implementation.\7\ Each person with a NASDAQ Workstation or Weblink ACT
2.0 log in will be able to access the alerts for a subscribed Limit
Locator MPID. The proposed fee is based on the cost to NASDAQ of
developing and maintaining the service, and on the value provided to
the subscribing member firm, which receives a useful tool with which to
monitor its trades reported to the TRF for compliance with the
requirements of the Plan. The proposed fee will also allow NASDAQ to
make a profit to the extent the costs associated with developing and
maintaining the service are covered. The proposed service is entirely
voluntary and member firms are free to develop similar systems of their
own or purchase third party solutions.
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    \5\ Securities Exchange Act Release No. 68841 (February 6,
2013), 78 FR 9966 (February 12, 2013)(SR-NASDAQ-2013-020).
    \6\ Beginning on February 4, 2013, the Securities Information
Processors began transmitting limit up/limit down data in select
securities to allow participants to develop and test their systems
in preparation for the implementation of the Plan.
    \7\ NASDAQ will prorate the first month's fee given that it is a
partial month.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \8\ in general, and with Sections [sic] 6(b)(4) of the
Act,\9\ in particular, in that it provides for the equitable allocation
of reasonable dues, fees and other charges among members and issuers
and other persons using any facility or system which the Exchange
operates or controls.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange operates in a highly competitive market in which third
parties and member firms themselves are able to develop and provide
information similar to that of Limit Locator. The service uses a
subscribing member firm's data, and as such, the member firm may elect
to capture it and perform the same analysis provided by Limit Locator,
or seek a solution from a third party. NASDAQ has invested time and
capital in developing the service and has determined that the proposed
fee is reasonable. Accordingly, to the extent that a member firm
believes that the fee is excessive or unreasonable it need not
subscribe to the service, and may alternatively capture and analyze the
data on its own or through a third party provider. Moreover, the
Exchange believes the proposed fees are reasonable because they are
based on the Exchange's costs to cover the development and maintenance
of the service. The proposed fee will allow the Exchange to recoup
these costs and make a profit, while providing member firms the ability
to better comply with the requirements of the Plan. The Exchange
believes the proposed fee is equitably allocated because all Exchange
member firms that voluntarily select this service will be charged the
same amount for the same service. As noted, subscription to the service
is entirely voluntary and available to all Exchange member firms that
are FINRA/NASDAQ TRF participants.

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

    NASDAQ does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended. To the contrary,
this proposal will promote competition among member firms, since it
provides a compliance solution to member firms that may not have the
financial wherewithal to develop such a system on their own. Moreover,
by promoting compliance with the Plan, the service will also promote a
more efficient and orderly market in which buyers and sellers can
compete amongst each other without inadvertently running afoul of the
restrictions of the Plan.\10\
---------------------------------------------------------------------------

    \10\ See supra note 4.
---------------------------------------------------------------------------

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

    Written comments were neither solicited nor received.

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

    Pursuant to Section 19(b)(3)(A)(ii) of the Act,\11\ NASDAQ has
designated this proposal as establishing or changing a due, fee, or
other charge imposed by the self-regulatory organization on any person,
whether or not the person is a member of the self-regulatory
organization, which renders the proposed rule change effective upon
filing.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2013-035 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-NASDAQ-2013-035. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room on official business
days between the hours of 10:00 a.m. and 3:00 p.m. Copies of such
filing also will be available for inspection and copying at the
principal offices of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NASDAQ-2013-035, and should be submitted on or before
March 29, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-05414 Filed 3-7-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 194 (Friday, October 5, 2012)]
[Notices]
[Pages 61011-61012]
[FR Doc No: 2012-24672]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

Notice of Adjustment of Countywide Per Capita Impact Indicator

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: FEMA gives notice that the countywide per capita impact
indicator under the Public Assistance program for disasters declared on
or after October 1, 2012, will be increased.

DATES: Effective Date: October 1, 2012, and applies to major disasters
declared on or after October 1, 2012.

FOR FURTHER INFORMATION CONTACT: William Roche, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In assessing damages for area designations
under 44 CFR 206.40(b), FEMA uses a county-wide per capita indicator to
evaluate the impact of the disaster at the county level. FEMA will
adjust the countywide per capita impact indicator under the Public
Assistance program to reflect annual changes in the Consumer Price
Index for All Urban Consumers published by the Department of Labor.
    FEMA gives notice of an increase in the countywide per capita
impact indicator to $3.45 for all disasters declared on or after
October 1, 2012.
    FEMA bases the adjustment on an increase in the Consumer Price
Index for All Urban Consumers of 1.7 percent for the 12-month period
ended in August 2012. The Bureau of Labor Statistics of the U.S.
Department of Labor released the information on September 14, 2012.

Catalog of Federal Domestic Assistance No. 97.036, Disaster Grants--
Public Assistance (Presidentially Declared Disasters).

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2012-24672 Filed 10-4-12; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 77, Number 140 (Friday, July 20, 2012)]
[Notices]
[Pages 42746-42747]
[FR Doc No: 2012-17667]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Advisory Committee for Pharmaceutical Science and Clinical
Pharmacology; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Advisory Committee for Pharmaceutical Science
and Clinical Pharmacology.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on August 8, 2012, from 8
a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-
0002. Information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    Contact Person: Yvette Waples, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), to find
out further information regarding FDA advisory committee information. A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: During the first session, the committee will discuss the
uses and limitations of in vitro dissolution testing and propose future
direction for evaluation including possible research. During the second
session, the committee will receive an update on the FDA's recently
posted draft guidances for industry on biosimilar products. This will
be an awareness topic and there will not be formal Committee discussion
or recommendation.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
August 1, 2012. Oral presentations from the public will be scheduled
between approximately 11 a.m. to 12 noon for the first session, and
3:45 p.m. to 4:15 p.m. for the second session. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before July 24, 2012. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may

conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by July 25, 2012.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Yvette Waples at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: July 16, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-17667 Filed 7-19-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: August 29, 2008 (Volume 73, Number 169)]
[Rules and Regulations]
[Page 50881-50883]
[DOCID:fr29au08-4]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Parts 206 and 207

[Docket ID FEMA-2006-0035]
RIN 1660-AA21

Management Costs

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Reopening of comment period.

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

SUMMARY: The Management Cost Interim Rule implemented the management
cost provisions in section 324 of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, as amended. The Federal Emergency
Management Agency (FEMA) is reopening the public comment period on its
Management Cost Interim Rule. FEMA is taking this action to solicit
data from grantees and subgrantees to use in reevaluating the fixed
management cost rates established in the rule.

DATES: Comments are due on or before September 29, 2008.

ADDRESSES: You may submit comments, identified by Docket ID FEMA-2006-
0035, by one of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments.
    E-mail<EMAIL_ADDRESS>Include Docket ID FEMA-2006-0035 in the
subject line of the message.
    Fax:<PHONE_NUMBER>.
    Mail/Hand Delivery/Courier: Rules Docket Clerk, Office of Chief
Counsel, Federal Emergency Management Agency, Room 835, 500 C Street,
SW., Washington, DC 20472.

FOR FURTHER INFORMATION CONTACT: Jonna M. Long, Office of the Chief
Financial Officer, Federal Emergency Management Agency, 500 C Street,
SW., Washington, DC 20472,<PHONE_NUMBER>, (facsimile)<PHONE_NUMBER>
(phone), or (e-mail<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

Background

    Under the provisions of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act (Stafford Act), 42 U.S.C. 5121-5207, and its
implementing regulations, the Federal Emergency Management Agency
(FEMA) has the authority to assist State and local governments in
carrying out their responsibilities pursuant to a Presidentially-
declared major disaster or emergency. Two of the major programs
authorized by the Stafford Act that provide assistance to State and
local governments are the Public Assistance (PA) program (grants for
emergency protective measures, debris removal, and repair, replacement,
or restoration of facilities not met by insurance) and the Hazard
Mitigation Grant Program (HMGP) (grants for sustained mitigation
measures such as acquisition for open space, elevations of flood prone
properties, and wind or seismic retrofitting of structures that will
reduce or permanently eliminate the long-term risk to people and
property from natural hazards and their effects).
    Section 324 of the Stafford Act, 42 U.S.C. 5165b, required FEMA to
establish management cost rates for PA and HMGP grantees and
subgrantees to be used in determining contributions for management
costs. On August 30, 2002, FEMA published a Notice of Proposed
Rulemaking that proposed a methodology for calculating the management
cost rates, as well as guidance for the implementation of section 324
of the Stafford Act (67 FR 56130). FEMA provided a 30 day comment
period for the Notice of Proposed Rulemaking and considered the
comments received in drafting the Interim Rule that was published on
October 11, 2007 (72 FR 57869). For the Interim Rule, FEMA again
provided a 30 day comment period. FEMA received 34 public comments on
the Interim Rule (all of which are available in the docket for public
inspection). Although FEMA continues to review those comments and will
address them in the final rule, FEMA realized that it would be useful
to solicit more specific information to properly address issues that
were raised in those comments.
    ``Management costs,'' for purposes of the implementing regulation,
include any indirect costs, any administrative expenses and any other
expenses not directly chargeable to a specific project that are
reasonably incurred by a grantee or subgrantee in administering and
managing a PA program or HMGP grant award. As established by the
Interim Rule, FEMA determines the amount of management costs based on a
flat percentage rate of the Federal share of projected eligible program
costs for financial assistance. The flat percentage rate for PA is 3.34
percent for major disaster declarations, and 3.90 percent for
emergencies. The HMGP rate is 4.89 percent for major disaster
declarations. The management cost funds provided are in addition to the
grantee's PA and HMGP funds and do not require a non-Federal cost
share.
    The management cost rates set forth in the Interim Rule replaced
what FEMA previously paid State and local governments for associated
costs through the ``sliding scale,'' State management costs, and
grantee indirect costs. The percentages for reimbursement are based on
historical average obligations. To create the figures in the Interim
Rule, FEMA used data collected in the National Emergency Management
Information System (NEMIS) for declarations from August 1998 to July
2004. FEMA added together actual obligations representing the Federal
share of all PA projects for major disasters declared during that
period. Obligations for sliding scale, State management costs, and
grantee indirect costs were excluded from project obligations and were
added together separately. Those totals were used to calculate the
percentage of ``pure'' project dollars that historically has been
required for administration and management.
    The same calculations were performed for HMGP projects under major
disaster declarations and PA projects under emergency declarations.

Request for Comments

    Instructions: All Submissions received must include the agency name
and Docket ID. Regardless of the method used for submitting comments or
supporting material, all submissions will be posted, without change, to
the Federal eRulemaking Portal at http://www.regulations.gov, and will
include any personal information you provide. Therefore, submitting
this information makes it public. You may wish to read the Privacy Act
notice that is available on the Privacy and Use Notice link on the
Administration Navigation Bar of http://www.regulations.gov.
    Although comments on other aspects of the interim rule will not be
rejected, FEMA solicits data in response to the specific requests set
out below:

Request 1

    Prior to November 13, 2007, FEMA used three mechanisms to reimburse
grantees and subgrantees for management and administration costs:
    a. ``Sliding Scale''--per section 406(f) of the Stafford Act, FEMA
reimbursed States for extraordinary costs incurred for preparation of
damage survey reports, final inspection reports, project applications,
final audits, and related field inspections by State employees,
including overtime pay and per diem and travel expense of such
employees but not including pay for regular time of such employees,
based on the total amount of assistance provided under section 403,
404, 406, 407, 502, and 503. Such funds were cost shared at the
prevailing cost share rate for the declaration.
    FEMA reimbursed subgrantees for associated expenses including
necessary costs of requesting, obtaining, and administering Federal
assistance. Such funds were 100 percent federally-funded.
    b. Category Z State Management Administrative Costs--FEMA
reimbursed State costs consistent with OMB Circular No. A-87 guidance,
including such items as straight time salaries of State employees;
straight time and overtime salaries, per diem and travel of contractors
administering PA or HMGP grants; Emergency Management Assistance
Compact (EMAC) costs for PA grants management; materials; equipment;
etc. Such funds were cost shared at the prevailing cost share rate for
the declaration.
    c. Indirect Costs--FEMA reimbursed States for costs incurred for a
common or joint purpose benefiting more than one cost objective that
were not readily assignable to projects, if such costs were part of an
approved Indirect Cost Rate Plan. Such funds were cost shared at the
prevailing cost share rate for the declaration.
    FEMA requests that grantees and subgrantees submit data on
unreimbursed management costs incurred in the management and
administration of Public Assistance (PA) and/or the Hazard Mitigation
Grant Program (HMGP) prior to implementation of the Interim Rule on
November 13, 2007. Specific costs and descriptions are needed and all
costs must be attributable to and identified by a specific FEMA
declaration number (DR-XXXX-ST or EM-XXXX-ST).
    To assist grantees and subgrantees in answering this request,
unreimbursed costs might include items eligible for sliding scale funds
when such funds were insufficient, or subgrantee costs not eligible for
sliding scale funds and therefore not eligible for FEMA reimbursement.
Unreimbursed costs must have been incurred in support of the management
and administration of

PA or HMGP under a specific Presidential declaration (major disaster or
emergency for PA or major disaster for HMGP), and not in support of
other programs such as community relations or Disaster Recovery Center
staff, or staff supporting Individual Assistance programs. Unreimbursed
costs do not include State cost shares required for sliding scale,
Category Z, or indirect cost funding, nor do they include costs that
were not reimbursed because they were inconsistent with applicable
Federal rules and cost principles, such as OMB Circular No. A-87.

Request 2

    FEMA requests that grantees and subgrantees submit available data
on unreimbursed management costs incurred in the management and
administration of Public Assistance (PA) and/or the Hazard Mitigation
Grant Program (HMGP) under a specific Presidential declaration (major
disaster or emergency for PA or major disaster for HMGP) since November
13, 2007. Specific costs and descriptions are needed and must be
identified by FEMA declaration number.

Viewing the Docket

    For access to the docket to submit comments, read the Notice of
Proposed Rulemaking, Interim Rule, background documents and all
comments received, go to the Federal eRulemaking Portal at http://
www.regulations.gov. To the far right is a section titled ``More Search
Options.'' Below that title, click on ``Advanced Docket Search.'' On
the next screen, in the box provided for Docket ID, type ``FEMA-2006-
0035''. The next screen will provide a link to the docket. Once viewing
the docket, all documents are provided in chronological order,
beginning with the 2002 Notice of Proposed Rulemaking. Submitted
comments may also be inspected at Office of Chief Counsel, Federal
Emergency Management Agency, Room 835, 500 C Street, SW., Washington,
DC 20472.

    Dated: August 22, 2008.
R. David Paulison
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-19983 Filed 8-28-08; 8:45 am]

BILLING CODE 9110-49-P