[Federal Register Volume 81, Number 101 (Wednesday, May 25, 2016)]
[Notices]
[Pages 33285-33286]
[FR Doc No: 2016-12238]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77856; File No. SR-MSRB-2016-06]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Notice of Filing and Immediate Effectiveness of a Proposed Rule
Change Consisting of Amendments to the MSRB's Amended and Restated
Articles of Incorporation

May 19, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'' or ``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\
notice is hereby given that on May 5, 2016, the Municipal Securities
Rulemaking Board (the ``MSRB'' or ``Board'') filed with the Securities
and Exchange Commission (the ``Commission'' or ``SEC'') the proposed
rule change as described in Items I, II, and III below, which Items
have been prepared by the MSRB. 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 MSRB filed with the Commission a proposed rule change
consisting of amendments to the MSRB's Amended and Restated Articles of
Incorporation (``Articles of Incorporation'') (``proposed rule
change''). The MSRB has designated the proposed rule change for
immediate effectiveness.
    The text of the proposed rule change is available on the MSRB's Web
site at www.msrb.org/Rules-and-Interpretations/SEC-Filings/2016-Filings.aspx, at the MSRB's principal office, and at the Commission's
Public Reference Room.

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

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

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

1. Purpose
    On March 17, 2016, the Commission approved a proposed rule change
consisting of amendments to MSRB Rule A-3, on membership on the
Board.\3\ The amendments, among other things, lengthened the term of
Board member service from three to four years and changed the number
and size of Board classes from three classes comprised of seven members
to four classes--one class comprised of six members and three classes
of five. Additionally, the amendments deleted a provision that related
to a previous transition process the MSRB used to increase its Board
size from 15 to 21 members and to be in compliance with new
requirements established by the Dodd-Frank Wall Street Reform and
Consumer Protection Act of 2010.\4\
---------------------------------------------------------------------------

    \3\ See Exchange Act Release No. 77390 (Mar. 17, 2016), 81 FR
15582 (Mar. 23, 2016) (File No. SR-MSRB-2016-01) (``SEC Approval
Order'').
    \4\ See Public Law 111-203, 124 Stat. 1376; Exchange Act Release
No. 65424 (Sept. 28, 2011), 76 FR 61407 (Oct. 4, 2011) (File No. SR-
MSRB-2011-11) (approving the MSRB's establishment of a Board
structure of 21 Board members divided into three classes, with each
class being comprised of seven members who would serve staggered
three-year terms).
---------------------------------------------------------------------------

    The purpose of the proposed rule change is to amend the Articles of
Incorporation as necessary and appropriate to conform them to amended
Rule A-3, as described above.\5\ The proposed rule change will become
operative on October 1, 2016, at the beginning of the first MSRB fiscal
year for which the new term length and class structure will apply, and
the MSRB will file the Articles of Incorporation with the Commonwealth
of Virginia at a later date in accordance with Virginia law.
---------------------------------------------------------------------------

    \5\ The MSRB will also amend its by-laws to reflect the recent
amendments to Rule A-3.
---------------------------------------------------------------------------

2. Statutory Basis
    The MSRB has adopted the proposed rule change pursuant to Sections
15B(b)(1) and (2) of the Exchange Act,\6\ which require, among other
things, that the rules of the Board establish fair procedures for the
nomination and election of members of the Board and assure fair
representation in such nominations and elections of public
representatives, broker-dealer representatives, bank representatives,
and advisor representatives and the terms that shall be served by such
members.\7\ The MSRB believes that the proposed rule change is
consistent with Sections 15B(b)(1) and (2) of the Exchange Act by
conforming the Articles of Incorporation of the Board to amended Rule
A-3.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78o-4(b)(1)-(2).
    \7\ 15 U.S.C. 78o-4(b)(2)(B).
---------------------------------------------------------------------------

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

    The MSRB does not believe that the proposed rule change will impose
any burden on competition not necessary or appropriate in furtherance
of the purposes of the Exchange Act, since the proposed rule change
simply amends the Articles of Incorporation of the Board to conform
them to amended MSRB Rule A-3 and solely concerns the administration of
the organization.

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 on the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \8\ and paragraph (f) of Rule 19b-4
thereunder.\9\ 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.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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-MSRB-2016-06 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-MSRB-2016-06. This file

number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the MSRB. 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-MSRB-2016-06 and should be
submitted on or before June 15, 2016.

    For the Commission, pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-12238 Filed 5-24-16; 8:45 am]
 BILLING CODE 8011-01-P


first time donations easily and if it's in pool.  So one
of the options at the moment would be at least before
the complete automation is available, one of the
possibilities would be to do individual testing for the
higher risk first time donation and the pool of 16 for
the repeat donors.

266
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
Thank you.
(Applause.)
DR. TABOR:  Thank you very much.  We now
have a panel discussion.  I'll try to end the session on
time.  If the members of the panel could come to the
table, please.  I think we'll begin our discussion with
the subject of single donor testing, but I would like to
allow it to be free ranging over any topic connected
with implementation of NAT.
I'd like to begin with a question for the
panel and I'd also like to invite the audience to
respond, perhaps some of the manufacturers.
I've heard concerns expressed that the
advent of single donor testing is going to possibly
cause delay in the filing of PLAs for minipool testing.
I would like to get some comments on that, if possible.
Perhaps Dr. Gallarda from Roche could comment on that
since it's sort of related in a kind of opposite way to
what he was saying.
DR. GALLARDA:  Well, I can just tell you
that from Roche's perspective, we intend to go full
steam ahead with filing for submission for the
Ampliscreen HCV and HIV products and our estimated
target date for this is the end of the first quarter of

267
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
next year.
We have a pretty active group doing a lot
of PCR assay development and I think the flip flop here
is that we don't expect to have a lot of impediment in
filing those because we're working actively on single
unit systems.  So I think our strategy is to provide
what, apparently, is going to be an effective means to
further close the seroconversion window, interdict NAT
only units and that's the minipool system that we've
developed.
DR. TABOR:  Dr. Busch.
DR. BUSCH:  I think that we did have a
resistance on the part of the other manufacturer, Gen-
Probe, and now a partnership with Chiron to really fully
support minipool testing.  They run a bandwagon, in
part, I think, with encouragement from FDA and NLBI to
move forward toward single donation testing and they
felt that there was potentially going to be an
acceptance of minipool testing.  What I think we've seen
though is with a lot of effort on our part and
cooperation, I think, from Chiron and now Gen-Probe, is
a commitment from that company to support minipool
testing and bring forward a licensed product.  They are,
in parallel, pursuing an IND claim for single donation

268
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
testing, but recognizing that the industry, at least for
the next few years is really intent on doing minipool
testing until, I think, the efficacy and cost and
reimbursement issues around supporting single donation
testing come forward.  So I think there has been
movement.  I would say that there's been great value
that there's been a competitor out there.  I think if
Roche had not been there, if you guys had not come to
the table two or three years ago and entered this
business that there may well have been a sort of
inexorable move to single donation testing even though
it may not have been in the interest of the industry.
DR. TABOR:  A question from the microphone
on the floor.
MR. HALVERSON:  Craig Halverson from
Gen-Probe.  I just wanted to confirm that Gen-Probe is
going forward with -- in parallel, with individual
donation testing as well as minipool testing and we do
not expect that individual donation testing will delay
in any way approval of minipool testing.
DR. TABOR:  Thank you.  Does anyone on the
panel have any comments or questions on the general
issues related to NAT implementation?
DR. CHUDY:  I think we should encourage

269
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
single unit testing because I think in the future when
NAT will replace the serological test.  It could only be
in the stage of single unit testing and in the moment
there are times to act and I think this is the new
solution.
DR. HELDEBRANT:  Chuck Heldebrant from
Alpha.  I think based on our experience with minipool
testing of plasma pools, I think it's premature to look
at single donation testing by NAT as a way to replace
serology.  They measure different things.  They
complement each other.  We look in the future to have
minipool testing of NAT to help us cover the window
period and serology testing to help us cover the more
developed periods of infection.  The objective we have
is we want to be able to detect any unit from any donor
at any time during the disease state.  That's what we
want to be able to do and as good as it is NAT doesn't
give us that capability.
DR. SALDANHA:  I'm not sure where the
serology comes in, but certainly when we discussed the
introduction of NAT testing it was always felt it was an
additional assay to ensure additional safety.  It was
never the idea to replace serology.  And as far as I
think we're concerned in Europe, serology assays are not

270
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
going to be replaced by NAT as an additional assay.
DR. STRAMER:  We may not necessarily agree
with that in the United States as you heard earlier.  I
mean there are specific assays that we can target
elimination such as p24 antigen that measures basically
the same thing as NAT, ALT, perhaps as we look at
hepatitis B screening anti cor.  So we are hopeful, even
those are not in your menu, except for ALT that we can
move to eliminating some of our current tasks with the
replacement of some more sensitive tests.
DR. KLEINMAN:  I wanted to agree with some
of the comments that Celso made previously about the
move toward single donation testing.  I think it is a
question of not if, but when and I think that since we
have demonstrated efficacy for minipool testing at a lot
of effort, I don't see the need to rush headlong in the
same rapid way into individual donation testing.  I
think we need to accumulate the data and we need to get
better at our laboratory turnaround time and we need to
as well get the automation up to the standards of
serology testing.  I don't think we should be going into
systems that are semi-manual for individual donation
testing given the potential problems they can generate
and given the fact that at least the models predict only

271
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
a small incremental benefit.  But I think once we get to
more automated systems, that incremental benefit will be
worth it, then we need to find a way to be able to pay
for it.  But that shouldn't stop us from doing it.
Those problems will need to be solved.  So I basically
think that Celso's rendition of the problem was a good
one but urge that we go on that course.
DR. TABOR:  Question from the floor.
DR. ALLAIN:  It's not exactly a question,
it's rather a comment.  I mean I was just going to say
the same thing as Steve just mentioned that on the basis
of our experience, the semiautomated system we are using
currently for single donation in molecular virology
laboratory like ours is difficult.  We have problems and
we need to solve them on a daily basis and so I don't
think as it is the technology would be suitable for
general use in blood banks, particularly knowing that
the level of molecular biology knowledge in the average
blood bank is often appalling, if I may say so, at least
it is the case in England and in some other countries,
including the U.S., I believe.
So I agree with Steve that unless
automation is there, I think that would be the absolute
necessity to implement it on individual donations.

272
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
DR. TABOR:  Dr. Bianco.
DR. BIANCO:  Actually just following those
statements, I think that the FDA has done that in many
ways in terms of looking at entire systems, not just the
chemistry of a test or the molecular biology of the
test, but the entire system and how it's going to work
in the field and I think that more and more with the
complexity of what we do, I think that as we look at NAT
testing and licensure, we should look at the entire
system, so we make sure that the outcomes are the
outcomes that we want.  We just don't have a test that
in the model somewhere in a corner works very well, but
when we throw it to the world that may not perform as we
need it to perform.
DR. TABOR:  I'd like to ask a question
about NAT testing for hepatitis B virus.  We've got
people from quite a number of countries here, Dr.
Nakajima from Japan, we've got at least two people from
Germany, Dr. Heerman and Dr. Chudy and can some of you
bring us up to date as to what is going to happen with
NAT testing for hepatitis B virus in your countries?
DR. NAKAJIMA:  I'm sorry, I didn't quite
understand what do you mean by "what's happening" --
DR. TABOR:  What are your regulatory plans

273
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
and what stage of investigation have you reached in
using NAT testing for screening for hepatitis B?
DR. NAKAJIMA:  When we include the
hepatitis B in our minimum requirement, we have to shut
down the import from the overseas of the imported plasma
products from overseas, so we cannot do that at this
moment.  Unfortunately, in our country, JRC is the only
one, collecting organization, and they do the HBV NAT
system already.  So we do not have the actual problem
concerning the transfusion products, so if the foreign
manufacturers are ready to implement HBV, we can proceed
to the minimum requirement including in the minimum
requirement of the HBV.  Until that, we have to collect
our data.
DR. TABOR:  Thank you.  That's very
interesting.  How about Germany and --
DR. CHUDY:  Of course, we are both thinking
about increasing HBV safety regarding to NAT and
opposite to the NTHBC testing.  And my view is it is now
difficult to define individualized QHQ compared to HC
because the detection unit must be so low as they can do
it.  What is so low?  I think maybe 300 or 400 copies
and that's as far as practice and other strategy -- HBV
testing for HC testing and also another kind of

274
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
extraction, of something.
I think at the moment you cannot take the
same extraction procedure for HBV you can't transmit to
extract HBV.  That's my personal view.  I think there is
no generic extraction procedure now that gives the same
efficacy for all nucleic acid.  I think this problem is
to be resolved.  It is helpful, I think, now we have a
WHO standard, we can start some collaboration studies to
see what is the detection unit of the different viral
copies and then we get an impression to come to a
decision.
DR. TABOR:  Yes?
DR. DODD:  I think that we need to be
rather careful not to walk in lockstep with every one of
the agents for which we might be able to test.  I have
some concerns about assuming that we need to be testing
for hepatitis B.  I'm not saying we don't need to be
testing, but I think we need to remember, for example,
that this is probably one of the agents that is
expressed most variably in terms of incidence and
prevalence around the world.  We've actually seen some
quite interesting data today already about a relatively
high yield for HBV detection, in some populations of
donors that have generally considered to be at somewhat

275
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
higher risk than those for single blood donations.  I
think we've also seen some interesting data from Japan
which has a very high prevalence and a significant
incidence of hepatitis B.  I think we need to recognize
that there is not apparently a major demonstrated risk
of HBV transmission in this country, perhaps in part
because we do do cor testing and I think any one of us
would be hard put to identify a recent case of
transmission of hepatitis B through a pooled plasma
product.
So my plea is let's be a little bit careful
and let's not regard it as an Everest and do it just
because it's there.  I think we need a really good
rationale before we make our lives even more complex.
You heard what Dr. Chudy said about the technical
difficulties inherent in looking for hepatitis B tests
in this environment.
DR. TABOR:  Dr. Stramer and then we'll take
the questions from the floor.
DR. STRAMER:  I have a question for the
FDA.  Along the lines of hepatitis B, even without NAT
testing using single donation testing we today have the
ability to close the window by the implementation of
more sensitive HBS Ag antigen tests or if the FDA chose

276
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
to evaluate those that are currently licensed, perhaps
the elimination of those with lesser sensitivity would
perhaps do more as far as yield for hepatitis B than
implementing a whole new technology.
DR. TABOR:  I'm not sure I have the full
answer to that.  My knowledge of the tests that are
licensed is that even though there is some variability,
even though they all meet the minimum FDA standards,
there is some variability from manufacturer to
manufacturer.  None of them would close the window
period.
DR. STRAMER:  Of course not, but there's
probably enough variability between the test which would
be greater in the amount of window period reduction than
by going to minipool HBV DNA testing.
DR. TABOR:  That's an interesting
perspective.  And the other question I guess would be if
somebody had an even better HBS Ag test than what's on
the market now, would we be pushed to implement that?
That's very interesting.
Yes, on the right hand.
MR. SNAPE:  Terry Snape, Bio Products Lab
in the U.K.  Just following up your question on
hepatitis B testing, Chairman, it's worth remembering

277
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
that in Europe there is no uniform mechanism for
mandating the testing of blood donations for, for
example, hepatitis B DNA.  HCV RNA testing came about
because of the CPMP requirement for testing of plasma
pools.  With the specific exception of Germany, it's
hard to see that HBV DNA testing would be mandated
generally in other member states.
DR. TABOR:  The other microphone?
MR. MacPHERSON:  Yes, Jim MacPherson.  A
lot of people know that the ABC members send about
600,000 liters a year of plasma to the Swiss Red Cross
and they have indicated just about a month ago that they
want us to implement HBV NAT by the end of 2000.  Now
they've put that request on hold because they are aware
that the data on pools that they're talking about using
the same size pools that we do now, that there are data
that would show that pools of 16 or 24 can also be
matched by some of the, for example, chemiluminescence
technology that's used in the Prism system.  But I
suspect that certainly within the next few weeks we're
going to be hearing back from them in terms of what the
requirement is actually going to be and how and that we
have to figure out how we would do that.
DR. TABOR:  And this would be for plasma?

278
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
MR. MACPHERSON:  Well, that's how we
started out doing what we're doing now was for plasma,
for recovered plasma.
DR. TABOR:  Dr. Heldebrant?
DR. HELDEBRANT:  Yes, again, one thing that
this emphasizes and really shows is that we have three
regions of the world that are all struggling with how to
implement NAT testing and they've all taken different
approaches.  Europe has taken an approach of saying
manufacturing pools for HCV have a manufacturing pool
limit.  The Kosasho in Japan has a requirement for
hepatitis B testing which is understood, given the
situation that they have in Japan.  The FDA has yet
another mechanism.  As a manufacturer's representative,
we have a situation where like it or not, we have to
comply with all three and so our plea, at least from the
plasma side is that please use the mechanisms for
harmonization and please harmonize where we're going
with NAT implementation and NAT regulation.  It will
make it easier for all of us and we'll have a much more
rational basis to apply it.
DR. TABOR:  Dr. Allain?
DR. ALLAIN:  I wanted to mention about the
HBV that the situation is much more difficult in my view

279
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
than for HIV and HCV.  In particular, we have shown
recently some data indicating that you can have NTHBC
present, an infectious unit which is negative by PCR or
reasonably sensitive PCR and we are not the only ones
who have shown that.
In addition, also in the literature, there
are some cases of HBS Ag positive sampled, confirmed
positive, which are DNA negative, whether or not it's
infectious is not clear, but presumably if you can
produce the protein that the likelihood of infectivity
is fairly high.  In addition to that as has been
mentioned today, the very low level in the pre-
seroconversion period is a problem, so I think it's
really a case of its own different -- or different from
the other that has to be looked at.  But in my view, I
think relying on genomic detection is not a good idea
and I think we are going to stay, we should stay
probably with the HBS Ag and NTHBC until things are
clarified.
DR. TABOR:  Any further comments from the
panel?  Dr. Stramer?
DR. STRAMER:  I have another question for
the FDA.
(Laughter.)

280
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
Hearing what you've heard over these
several meetings on NAT that FDA has held or Blood
Products Advisory Committee has held or even your other
meetings with IND sponsors, what time line in a perfect
world would you design, starting perhaps from product
release and then licensure, could you outline something
for us that perhaps the Agency would like to see?
DR. TABOR:  Well, I don't know if I'm
answering you directly, but you know the licensure of
any product is governed not by what FDA wants, but by
what the sponsor wants because it depends on when it's
submitted and when the data is complete and when the
deficiencies are corrected.  And in addition, as you
know, we're not allowed to talk about -- actually, it's
forbidden by law to talk about products under
consideration.
DR. STRAMER:  I'm not asking for specifics.
I'm saying if you could create a perfect world with
CGMP compliance, no deficiencies in batch records, we're
living in an ideal world.
DR. TABOR:  Okay, well, in an ideal world,
under -- actually Dr. Epstein took a daring step, but a
very good one in permitting or encouraging FDA to permit
the use of NAT screening for HCV under IND and I believe

281
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
that began by most manufacturers in -- pardon me?
DR. STRAMER:  Early 1999 to mid-1999.
DR. TABOR:  And some were beginning earlier
than that, really.
DR. STRAMER:  For plasma.
DR. TABOR:  Right.  1998 for plasma,
probably.  So for plasma you've got -- you've had two
years to collect data, you know, I would have expected