[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Rules and Regulations]
[Pages 61985-61987]
[FR Doc No: 2016-21410]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-6901; Directorate Identifier 2015-NM-192-AD;
Amendment 39-18646; AD 2016-18-15]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 737-600, -700, -700C, -800, and -900 series
airplanes. This AD was prompted by an evaluation by the design approval
holder (DAH) indicating that the aft pressure bulkhead is subject to
widespread fatigue damage (WFD). This AD requires repetitive
inspections of the aft pressure bulkhead web for any cracking, crack
indications, discrepant fastener holes, and corrosion; and corrective
actions if necessary. We are issuing this AD to detect and correct
cracks in the aft pressure bulkhead web, which could result in an
uncontrolled decompression of the fuselage.

DATES: This AD is effective October 13, 2016.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of October 13,
2016.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Data & Services
Management, P. O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone
206-544-5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
6901.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
6901; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Docket Management Facility, U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Alan Pohl, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office
(ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-
6450; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain The Boeing Company
Model 737-600, -700, -700C, -800, and -900 series airplanes. The NPRM
published in the Federal Register on June 21, 2016 (81 FR 40208) (``the
NPRM''). The NPRM was prompted by an evaluation by the design approval
holder (DAH) indicating that the aft pressure bulkhead is subject to
widespread fatigue damage (WFD). The NPRM proposed to require
repetitive inspections of the aft pressure bulkhead web for any
cracking, crack indications, discrepant fastener holes, and corrosion;
and corrective actions if necessary. We are issuing this AD to detect
and correct cracks in the aft pressure bulkhead web, which could result
in an uncontrolled decompression of the fuselage.

Comments

    We gave the public the opportunity to participate in developing
this AD. We have considered the comments received. Boeing, the Airline
Pilots Association International, and United Airlines supported the
NPRM.

Effect of Winglets on Accomplishment of the Proposed Actions

    Aviation Partners Boeing stated that accomplishing the supplemental
type certificate (STC) ST00830SE does not affect compliance with the
actions specified in the NPRM.
    We agree with the commenter. We have redesignated paragraph (c) of
the NPRM as (c)(1) and added a new paragraph (c)(2) to this final rule
to state that installation of STC ST00830SE does not affect the ability
to accomplish the actions required by this final rule. Therefore, for
airplanes on which STC ST00830SE is installed, a ``change in product''
Alternative Method of Compliance (AMOC) approval request is not
necessary to comply with the requirements of 14 CFR 39.17.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD with the change described previously and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

    We also determined that this change will not increase the economic
burden on any operator or increase the scope of this AD.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 737-53A1248, Revision 2,
dated October 14, 2015. The service information describes procedures
for low frequency eddy current, or high frequency eddy current, and
detailed inspections of the bulkhead web for cracking, crack
indications, discrepant fastener holes, and corrosion. This service
information is reasonably available because the interested parties have
access to it through their normal course of business or by the means
identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 680 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
            Action                       Labor cost               Cost per product       Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Inspections..................  34 work-hours x $85 per hour   $2,890 per inspection     $1,965,200 per
                                = $2,890 per inspection        cycle.                    inspection cycle.
                                cycle.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that enables us to provide cost
estimates for the on-condition actions specified in this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2016-18-15 The Boeing Company: Amendment 39-18646; Docket No. FAA-
2016-6901; Directorate Identifier 2015-NM-192-AD.

(a) Effective Date

    This AD is effective October 13, 2016.

(b) Affected ADs

    Certain requirements of this AD terminate certain requirements
of AD 2005-21-06, Amendment 39-14344 (70 FR 61226, October 21, 2005)
(``AD 2005-21-06'').

(c) Applicability

    (1) This AD applies to The Boeing Company Model 737-600, -700, -
700C, -800, and -900 series airplanes, certificated in any category,
line number 1 through 1755, as identified in Boeing Alert Service
Bulletin 737-53A1248, Revision 2, dated October 14, 2015.
    (2) Installation of Supplemental Type Certificate (STC)
ST00830SE (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgSTC.nsf/0/38B606833BBD98B386257FAA00602538?OpenDocument&Highlight=st00830se)
does not affect the ability to accomplish the actions required by
this AD. Therefore, for airplanes on which STC ST00830SE is
installed, a ``change in product'' alternative method of compliance
(AMOC) approval request is not necessary to comply with the
requirements of 14 CFR 39.17.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by an evaluation by the design approval
holder (DAH) indicating that the aft pressure bulkhead is subject to
widespread fatigue damage (WFD). We are issuing this AD to detect
and correct cracks in the aft pressure bulkhead web, which could
result in an uncontrolled decompression of the fuselage.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Repetitive Inspections

    At the applicable time specified in paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 737-53A1248,
Revision 2, dated October 14, 2015, or within 18 months after
November 25, 2005 (the effective date of AD 2005-21-06), whichever
occurs later: Do a low frequency eddy current (LFEC) or high
frequency eddy current (HFEC) inspection, and a detailed inspection,
of the aft and forward sides, as applicable, of the aft pressure
bulkhead web at the Y chord, above and below stringer S-15L and
stringer S-15R, to detect discrepancies (including cracking, crack
indications, discrepant fastener holes, and corrosion), in
accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin 737-53A1248, Revision 2, dated October 14, 2015.
Access and restoration procedures specified in the Accomplishment
Instructions of Boeing Alert Service Bulletin 737-53A1248, Revision
2, dated October 14, 2015, are not required by this AD. Operators
may do those procedures following their maintenance practices.
    (1) If no discrepancy is found: Repeat the inspections
thereafter at the applicable times specified in paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 737-53A1248,
Revision 2, dated October 14, 2015.

    (2) If any discrepancy is found: Do the actions specified in
paragraphs (g)(2)(i) and (g)(2)(ii) of this AD.
    (i) Repair the discrepancy before further flight using a method
approved in accordance with the procedures specified in paragraph
(j) of this AD.
    (ii) On areas that are not repaired, repeat the inspections
thereafter at the applicable times specified in paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 737-53A1248,
Revision 2, dated October 14, 2015.

(h) Terminating Action for AD 2005-21-06

    Accomplishment of the initial inspections required by paragraph
(g) of this AD terminates the requirements of AD 2005-21-06.

(i) Credit for Previous Actions

    This paragraph provides credit for the actions specified in
paragraph (g) of this AD, if those actions were performed before the
effective date of this AD using Boeing Alert Service Bulletin 737-
53A1248, dated September 9, 2004; or Boeing Alert Service Bulletin
737-53A1248, Revision 1, dated September 10, 2007; which are not
incorporated by reference in this AD.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (k)(1) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Seattle ACO, to make those findings. To be approved, the
repair method, modification deviation, or alteration deviation must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.

(k) Related Information

    (1) For more information about this AD, contact Alan Pohl,
Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft
Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-
3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (l)(3) and (l)(4) of this AD.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Alert Service Bulletin 737-53A1248, Revision 2, dated
October 14, 2015.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on August 30, 2016.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-21410 Filed 9-7-16; 8:45 am]
 BILLING CODE 4910-13-P


centers can test to 20,000 to 30,000 samples per day.
The sensitivity of the test is less than 100 copies or
international units per mL and 50,000 per mL at 500
pool.  Most of the genotypes listed here are covered by
this system.
Next.  Japan is composed of four main
islands and many small islands including Okinawa.
Samples are transported twice a day from blood centers
to two NAT centers by trucks on the ground and aircraft.
The third NAT center will be located in the western
part of Japan.
Next.  Until now, serological window cases
are detected by the NAT.  Among the source plasma
samples of more than five million most frequent was the
HBV, 1 in 72,000.  The dominant genotype was C, 78
percent; and B, 12 percent in contrast to Type A and D
dominant in western countries; and five mutations were

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found.  The close relationship between pre-cor mutation
to stop E antigen production and found hepatitis was
observed in Japan.
The frequency of HCV was 1 in 535,000.  The
dominant genotype was 1B, 70 percent; and Type 1A, which
is common in western countries, was very rare.  The
frequency of HIV was 1 in 2,631,000.  Whole donation
screening was done on 1.2 million samples up to now and
HBV, 8; HCV, 3; and HIV, none were detected.  It is said
that as high as seven percent of the population are HBV
carriers and half of 300 million world-wide HBV carriers
are in Asia.  In Japan also, it is estimated that 1.4
million are HBV carriers and 17 percent of deaths by
hepatoma is from hepatitis B.  Therefore, we consider it
is necessary to include HBV in Japanese NAT system.
Next.  As a conclusion, the next step of
NAT we consider would be, first, quality assurance and
quality improvement; and second, reduce the time
necessary for testing including logistics; and third,
although accurate estimation of cost is not calculated
yet, to make the test more cost effective; and fourth,
a single donation testing and automated system; and
fifth, to cope with emerging pathogens and how far and
to what extent.

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The evaluation of NAT still needs careful
consideration, such as the relationship between NAT data
and infectivity, but the results obtained so far and
theoretically NAT is very promising to play a role as a
fundamental test of pheresis in an attempt toward the
goal of totally safe blood products.  Thank you for
listening.
(Applause.)
DR. TABOR:  Thank you very much, Dr.
Nakajima, for a very clear and interesting talk.
I'd now like to introduce Dr. John Saldanha
who is well known to all of you because of his
leadership in developing standards for RNA detection for
these viruses.  Dr. Saldanha is from the Division of
Virology at the NIBSC in Potters Bar, just outside
London.
DR. SALDANHA:  Thank you, Mr. Chairman.
I'd like to thank the organizers for inviting me to
speak today, and I hope in my talk I'm going to give you
a brief introduction to standardization of NAT assays
and the quality assurance of these assays.  Now we've
heard from previous speakers about the implementation of
NAT, and what I'm going to show in this talk is that
this has only been possible because of the establishment

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of working reagents and international standards.
May I have the next one, please.  Why do we
need to standardize these assays?  I think you're all
familiar with the fact that NAT assays are very
sensitive, and the sensitivity can vary from laboratory
to laboratory.  We were also concerned as a control
laboratory that there would be discrepant results
between manufacturers of blood products and the control
authorities which could lead to problems with the
release of the final products.  So these really were the
early discussions we had.
And before, as you realized, before you can
routinely introduce NAT, you need to have some sort of
standardization of these assays.
Next one, please.  And how do we go about
standardizing assays?  I think the first thing to do is
to use the calibrated reference reagent which is also
known as the run control to insure reproducibility from
run to run and to establish an internationally accepted
standard, and these are normally WHO international
standards.
Now at NIBSC, the way we develop working
reagents is to first of all start a collaborative study
which involves manufacturers control authorities'

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independent labs; and based on the results of these
studies, we prepare a working reagent and the working
reagent is at a dilution that can be easily picked up by
the majority of labs.  We then evaluate the reagent by
sending it out to laboratories and getting results back
on a monthly basis, and then finally move to the stage
of developing an international standard.
Next one.  Here I've listed some of the
collaborative studies we've done at NIBSC, starting in
1990 with a study done by Janet Butman to look at the
variation and sensitivity of assays to detect HIV DNA,
ending with the bottom which are the three studies to
establish the international standards for HCV, HBV and
HIV.
Next one.  On this slide I list some of the
reagents that are available.  We have working reagents
for most of the commonly looked at viruses which is C,
HIV B19 and we also have a multiplex reagent which has
four of the viruses.  In fact, we now have an agent
which has hepatitis B in it as well.  And there are two
working reagents for HIV RNA and a working reagent for
HBV, and I'd like to point out that there is a leaflet
outside by the registration desk which lists these
reagents and for those of you who are interested in

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information on ordering them.
May I have the next one?  And I think as a
previous speaker mentioned, we now have WHO
international standards.  The reasons for establishing
international standards, I think are quite clear.  At
the moment we have several working reagents which are
either calibrated in genome equivalents, and in the
U.S.A. I think you're very fond of copies per mL, and
some people talk about PCL detectable units per mil.
And it's very difficult if you try and compare results
from different laboratories to find some sort of common
ground.  What the WHO does is to establish an
international standard which is calibrated in a commonly
accepted unit, and this is a very arbitrary unit called
the international unit, and then the next step is to
calibrate all the existing working reagents against the
international standard.
Next one.  At present we have three
international standards that have been established.  The
first standard was the hepatitis C virus international
standard which as was mentioned previously is a
lyophilized preparation off of the genotype 1A isolate
and each vial contains 50,000 international units.  This
is defined.  This standard was established in 1997.  In

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October this year there were two further standards
established: the hepatitis B international standard
which is a genotype A, subtype adw and this standard
contains one million international units per vial.  And
finally, the HIV-1 international standard which is based
on a CBER material which is a positive donation diluted
in defibrinated plasma and lyophilized.  In this
standard, each vial contains 100,000 international
units.  So at present we have three international
standards that have been established and we're planning
to establish the standard for Parvovirus B19 in the near
future.
Next one.  Okay, and I think Michael Chudy
showed this.  Having established the standard for
hepatitis C virus RNA, we then calibrated some of the
commonly available working reagents against the standard
and this table shows the calibration and international
units of the standard such as the
Paul-Ehrlich, the NIBSC standard, the CLB Pelispy, the
standard from the Institute Superior di Sanita in Rome
and the CBER Panel No. 1 which is part of the panel that
May Nguyen has established.  And on the right hand
column you can see the calibration of international
units.  So it's now possible if a laboratory uses any of

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these working reagents to directly compare the results
with a laboratory using one of the other reagents.  So
I think you can see the value of calibrating everything
in a common unit.
One of the things that is confusing is the
correlation between the international unit and genome
equivalence.  And the international standard has been
assigned a titer to 10 international units per mL and
5
this is not dependent on the sensitivity of the assay.
It's defined as having some international units.
In contrast, when laboratories quantitate
samples in genome equivalence or copies per mL, the
figure they end up with is very dependent on the
sensitivity of the assay.  So what this means is that
the ratio of genome equivalence per mL to international
units will vary depending on the sensitivity of the
assay.  And I haven't got the slide here, but I have
data which shows that it can vary anything from one
international unit being equivalent to three genome
equivalence right up to eight genome equivalence.  And
I think the only accurate way of trying to decide this
is to run a sample in parallel with the international
standard and get a direct correlation in IU.
May I have the next one, please?  Okay,

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I'll switch slightly and talk about the quality control
of NAT assays.  Michael Chudy talked about the
validation of NAT assays, and I won't go into this, and
as Michael sort of said, there are guidelines from the
European Pharmacopoeia that pertain to the validation of
NAT assays.  Another way to insure the quality of the
NAT assay is to use a calibrated working reagent or a
run control in every assay run.  And finally,
participation in proficiency studies is to be
recommended.
Next one.  One of the things we do -- we
established a working reagent for hepatitis C virus RNA
back in 1994, and this sample was sent out to different
labs, and we recommended testing the sample neat, 1 in
10, and 1 in 100 dilution.  The sample contains roughly
4,000 genome equivalence per mL which by calibration
against the international standard is just 700
international units per mL.  And laboratories return
results to NIBSC every month.  We analyze the results,
and send out a report on a yearly basis.
And I think in the next slide I'll show you
some results which give you an idea of what happens.
Now these bubble plots represent the number of positive
assays over a time period, and you can see that

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laboratories can either pick all of them up as in A or
fail to pick any of the samples up as in D.  I think
this illustrates the use of using a working reagent.  In
fact, in laboratory B the assay improved over time by
changing the extraction method.
Next one.  Finally, this is the result of a
recent proficiency study that we run in the U.K. with
five laboratories, and we had a dilution panel of
genotype 1 and a genotype 3 sample, and you can see that
most laboratories were able to pick up between 20 to 50
international units per mL in this proficiency panel.
This was a blind panel that was sent five labs.  And
we're hoping to send out similar panels twice a year to
labs for the proficiency.
Next slide.  This slide briefly shows the
distribution of the working reagents.  We started off
with HCV and we reached a peak of the distribution in
1998, and that's dropped a bit this year because people
have calibrated their own in-house working reagents
against the international standards, so they don't need
to use a commercial reagent.  We have reagents to B19
and the use of that is increasing which I think shows
the interest in this virus.  HAV is pretty slow at the
moment and we have just started sending out samples for

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HBV.
Next one.  And on this slide it shows
distribution of hepatitis C working international
standard and the B.  And you can see that the use of the
international standard has increased as people calibrate
the assays in international units.
And finally, I'll talk a little bit about
the introduction of NAT testing and some of this has
been covered by Michael Chudy.  One of the original
reports in 1994 you're all familiar with was on the
transmission of hepatitis C by intravenous
immunoglobulins and the introduction of testing steps,
and following this CPMP urged marketing authorization
holders to develop and validate similar assays.  May I
have the next one?
And again, there were recommendations on
intramuscular immunoglobulin testing in 1995 and
recommendations by the CPMP but no final date set.
May I have the next one?  And this is a
slide that Michael showed and this is really the
discussion in the biotechnology working party on the
introduction of nucleic acid testing.  And I wanted to
show you this to try and illustrate how the biotech
working party arrived at the figure of 100 international

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units per mL for the tests.
I think we might skip.  So again, some of
the things that were discussed in the biotechnology
working party back in May 1997 were the problems with
using assays of different sensitivities which I've
talked about, the level of control that should be used,
and the EAPPI and EPFA proposed a detection limit of
1,000 genome equivalence per mL, while the control
authorities wanted to have more like 400 genome
equivalents per mL which was equivalent to 1 in 10
dilution of the working reagent.
And this data was based on some of the data
we got back from laboratories who could pick up 400
genome equivalence in all assays, and these were several
manufacturers and some control authorities.  So the
reason for setting the limit at 400 was based on hard
data that we had collected over several years.
Next one.  And on the 20th of February 1998
with the establishment of the international standard
which was established in October 1997, we then said that
the level could be set at 100 international units per mL
which was equivalent to 400 genome equivalents or a 1 in
10 dilution of the NIBSC standard.
Next one.  And what was decided was that

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the run control should be positive in every assay run,
and the level at which it was set was critical.  If the
level was too high, then laboratories with less
sensitive assays could pass batches of blood products
which would fail in other laboratories and this was a
concern.  And conversely if the level was set too low,
this would result in the majority of assays failing and
having to be repeated.  So it was quite critical at
which level the standard was set.
Next one.  And to show that it was -- that
100 international units per mL was achievable, we shared
some data that was collected during the collaborative
study to establish the international standard, and you
can see that most of the laboratories could pick up less
than 100 international units per mL in 95 percent of the
assays.  That was 95 percent detection limit.
Next one.  And so based on all this data
and after all this discussion, the CPMP said that from
the first of July batches would have to be tested for
HCV, and the limit would be 100 international units per
mL so this limit was based on hard data rather than
plucked out of the air.
Could I go to the last one, please?  So I
think what I want to conclude with is that it was very

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important to set up international standards and working
reagents which were calibrated before we could think
about introducing routine testing of NAT.  And I'll
finish up by doing some advertisements, I think. The
next NIBSC/EPFA workshop which is going to be on May
10th and 11th next year is going to be held in Madrid,
in Spain, and it's sponsored by the Spanish Medicines
Agency and that would be followed on the 12th by the
SoGAT workshop which is a WHO workshop on the 12th of
May.
Thank you very much.
(Applause.)
DR. TABOR:  Thank you very much, Dr.
Saldanha.  I enjoyed your talk.
We will now take a break which I think is
listed on the agenda as too short.  I think we ought to
have at least 20 minutes because of the possibility of
lines where you get coffee.  You can get coffee in any
of three places.  There's a cafeteria on the floor below
this which you reach by going left after you go out the
doors and down a stairwell.  There is another cafeteria
that you reach by going straight back after you leave
these doors, as far as you can go and then ask
directions.  It's on the second floor.  And there's also

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a Starbucks Coffee stand that you would pass on your way
going straight back from these doors.  So we'll start
again in 20 minutes.  Thank you.
(Whereupon, the meeting went off the
record at 9:53 a.m. and went back on the
record at 10:17 a.m.)
DR. TABOR:  For anyone who is just outside
the doors, could you pass the word that we're about to
begin?
We're beginning approximately or nearly 20
minutes after the scheduled time to begin.  And because
of that the second session of the morning will run 20
minutes later than scheduled.
The next session is about the industry's
experience with NAT screening of donors to date, and
it's divided into two parts.  The first is primarily
related to screening source plasma, plasma for further
manufacturing derivatives, and the second part dealing
with blood bank screening which, of course, involves
both whole blood and its components and the resultant
recovered plasma.
The moderators of these two sessions are
Dr. Andrew Dayton who is in the Laboratory of Molecular
Virology at CBER and Dr. Robin Biswas who is in the

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Division of Emerging and Transfusion Transmitted
Diseases in CBER.  The moderators of this session will
introduce the speakers and because of the time
limitations, I want to remind the speakers to try to
limit their talks to eight or nine minutes, if at all
possible.  The two portions of this session will be
followed by a short discussion period, and I realize
that it's a short discussion period, so that if there's
interest in further discussion, we can continue the
discussion after lunch.
I'll turn over the microphone to Drs.
Biswas and Dayton.
DR. DAYTON:  Okay.  Well I think everybody
seems to have largely returned to their seats.  Why
don't we just get started.  Let me remind you again that
we have about ten minutes per speaker so if each speaker
would aim for about eight or nine minutes, we could stay
on schedule.
In the first section on Plasma for Further
Manufacturing, the first speaker is Andrew Conrad from
NGI.
DR. CONRAD:  All right.  I'm going to sort
of set the table for my colleagues from Alpha and
Baxter, and we're going to describe some of the

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