concerning parvovirus B19.
[Slide]
Finally, I would like to thank Glenda Sylvester
for these slides and you for your attention.
DR. EPSTEIN:  Thanks to you, Dr. Nubling.  If
there are one or two pointed questions for Dr. Nubling?
Dr. Tabor?
DR. TABOR:  Yes, I want to ask a couple of
questions about the HCV core antigen information, and I
apologize if I misunderstood what you said.  Are there
countries in Europe where it is being used in place of NAT,
or is it being used in addition, or do the individual
centers have a choice as to which to use?
DR. NUBLING:  In Spain and Italy it is up to the
blood donation centers to use NAT or core antigen.  So,
they can use either of these.
DR. TABOR:  And this is for blood?
DR. NUBLING:  This is for blood components, not
for plasma.
DR. TABOR:  And is the technology that is used
all the same or are there several different manufacturers?
DR. NUBLING:  To my knowledge, there is only one
manufacturer.  It is Ortho which is present at least on the
European market, and this test is also used in these

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
countries.  Poland is the one country which introduced for
the time being, on a study basis, HCV core antigen only;
not NAT because of the high costs.  But it is not clear at
the moment if they will continue with this or if they will
change the current requirement.  But for the time being
they have identified quite a huge number of antigen-
positive donations which would not have been detected.
DR. TABOR:  One last question, is there a
reference standard for the core antigen test in the
European Union?
DR. NUBLING:  No.
DR. TABOR:  Thank you.
DR. EPSTEIN:  Dr. Bianco?
DR. BIANCO:  Celso Bianco.  I was a little bit
confused about your discussion on B19.  On one side, you
said there is a lack of well-defined description of the
benefits that would come from screening for B19.  On the
other hand, you mentioned a guideline that comes from the
EMEA that would regulate that screening.  So, you predict
that this would be a mandated assay for plasma derivatives
in Europe?
DR. NUBLING:  If this is followed it will be
mandatory for NAT immunoglobulin only for the time being
because this is defined for a risk group for parvovirus B
infection and, therefore, this is at least the first

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
regulation which will be in place probably in the near
future.
DR. EPSTEIN:  Dr. Allain?
DR. ALLAIN:  I still have some trouble with the
difference, massive difference, eight times difference in
HCV RNA positive between the Red Cross and the non-Red
Cross centers, and I wanted to make sure of several
elements. First, the pool size is the same?
DR. NUBLING:  No.  In Germany we rely on the
sensitivity requirement, 5000 international units have to
be detected and there are different approaches to detect
this.  So if you have a high sensitive assay, the pool size
may be higher or bigger compared to an assay which has
lower sensitivity.  So, it is sure that the 5000
international units is fulfilled for all places, for the
German Red Cross and for the other blood conation centers.
DR. ALLAIN:  Second, I understand that at least a
couple of years ago maybe until now some centers use ultra
centrifugation prior to testing.  Is that still in place
particularly with the Red Cross or only the other centers?
Or, what is the status of that?
DR. NUBLING:  It is still in place for at least
one big Red Cross center, as far as I know and, of course,
this centrifugation also has to be controlled by a run

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
control which reflects the 5000 international units.  It is
still in place.
DR. ALLAIN:  Finally, is there any difference in
the percentage of first-time donors between the two
populations?
DR. NUBLING:  It is a question I cannot answer
immediately.
DR. ALLAIN:  Because the difference of eight
times is just about what you would expect between first-
time and repeat donors.
DR. NUBLING:  Okay, but, of course, the number of
the smaller centers are not only first-time donors.  But I
cannot say what the percentage of first-time donors is in
the two different settings.
DR. EPSTEIN:  Thank you.  We have a few more
minutes for just general discussion.  I assume that any of
the earlier speakers will be pleased to respond if there
are questions to be raised.
Perhaps I will start off with
a question for Dr. Alter.
You made a point that hepatitis G has not been
found in the liver.  But then you showed us that it readily
affects PBMCs.  So, I think one question we might ask
ourselves is whether we should be looking for an
immunological disease if there is a disease to be found.

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
DR. ALTER:  I think one has to decide whether to
make the effort to look for these infections as a group in
all kinds of diseases, and certainly diseases where
lymphocytes or cells involved would be a good starting
point.  The data on the mononuclear cells came from
infectious clone that Dr. Stapleton has developed.  I
didn't realize that was available until his paper came out.
DR. EPSTEIN:  Thank you.  Could I ask anyone who
speaks up to please use the microphone and please identify
yourself for the sake of the transcription?  Any other
comments or questions?
[No response]
Well, we will take advantage of a little extra
time.  Let me ask you to be back at 10:55 so that we can
stay on time.
[Brief recess]
DR. YU:  Let me introduce the first speaker, Dr.
John Saldanha.  He really doesn't need to be introduced for
this audience.  He is going to talk about the NIBSC/WHO
program.  Let's welcome Dr. John Saldanha.
II.  Standardization/Quality Assurance
NIBSC/WHO Program
DR. SALDANHA:  Thank you.
[Slide]

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
I would like to thank the organizers for inviting
me to this meeting.  What I hope to do in the next 20
minutes is to go through very briefly on the ways that we
established the WHO standards for NAT testing and the
working reagents.  Then, at the end I would like to talk
about some quality assurance programs that we run.
[Slide]
I will start off with some definitions.  NAT
assays -- what are we trying to do with NAT assays?  We are
trying to measure the amount of nucleic acid in a sample.
And, in the past, before we had standardization, these were
measured in a variety of units, either genome equivalents
or copy numbers or not detectable units.  A program of
standardization was started in order to assure the quality
of data coming out of testing laboratories.
In order to be able to standardize assays, we
need to provide standards or working reagents and these are
reference materials which are used in assays to look at the
genome equivalents, in this case the variable being
measured.  To be able to do this, we established WHO's
international standards.
[Slide]
The different systems that we know for measuring
nucleic acids in samples -- we have got RT-PCR systems, TMA
and B-DNA assays.  These are used in some form or another,

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
either as qualitative or quantitative assays.  If you use
any of these assays, I can guarantee you would get
different answers for the amount of viral RNA or nucleic
acid in the system.  This is because nucleic acids are not
equivalent in all sorts of preparations.  You have
incomplete genomes; secondary structures which might affect
the quantitation, etc., etc.  I think it is very difficult,
using these systems, to be able to compare results.
[Slide]
With the WHO standards we use a common unitage
which is the international unit, and this is an arbitrary
unit.  This is to get away from nucleic acid molecules or
to use the SI systems which is nanomoles per liter which,
in my opinion, are very difficult to accurately determine.
It is, I think, virtually impossible to work out accurately
the number of genome equivalence.  So, to get around this
problem we defined an arbitrary unit which is the
international unit.
[Slide]
International standards are used as a gold
standard.  These are standards that are established by the
WHO.  In turn, they are used to calibrate secondary
standards and then working reagents or run controls which
are used to control each assay run.

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
There are several requirements for a WHO
international standard.  They should ideally be a
lyophilized preparation so that they have long-term
stability, and we do assays to prove this which I will show
you later on.  We should have adequate supplies of the
reagent to last ideally five to ten years.  And, and this
is important, we normally do a collaborative study using
laboratories from as many different countries as possible
to establish these standards.
[Slide]
The establishment takes a very sort of set form.
We identify candidate materials and assess the suitability
such as stability; organize a collaborative study and
assign a unitage -- a concentration in terms of
international units per milliliter.  We then send a report
to the WHO expert committee on biological standardization
which meets once a year, and this committee then
establishes the standard.
[Slide]
With the studies that we have done so far, we
have done several studies.  We have looked at hepatitis C
right through to hepatitis A, and we normally have a
variety of candidate materials.  In the first study we had
two materials from NIBSC and a liquid preparation from CLB,
in Holland.  With HIV, we had a material from CBER which

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
was lyophilized, and with B19, the same thing, and with
HAV, which is our latest standard, we had materials from
ISS, in Italy.  The ones that are colored, the candidate
samples, went on to become the eventual WHO standards.
[Slide]
These are the standards which we have
established.  The first WHO standard for NAT testing was
established in 1997 for hepatitis C virus RNA.  This was
followed by two standards established in 1999 for HIV-1 RNA
and hepatitis B DNA.  The parvovirus standard was
established last year, and we are completing the study on
the hepatitis A standard.  So, these are the four major
blood-borne viruses which have WHO standards established.
[Slide]
What do these standards consist of?  These
standards are wild type viruses diluted in plasma or
cryosupernatant.  The hepatitis C is genotype 1A and has 5
times 10 international units per vile.  The B is a genotype
4
A, surface antigen subtype ADW2.  The HIV-1, which is the
material from CBER, is genotype B material, and these have
all been assigned concentrations in international units per
milliliter.
[Slide]
We choose the concentration in international
units per milliliter to be as close to the determined value

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
in NAT units per milliliter.  This is to save a bit of
confusion.  Of course, the quantitation, as I mentioned
earlier, will differ with different viruses.  So, the ratio
of international units to NAT detectable units per
milliliter will also differ for each virus.  What I think I
am trying to get away from is to encourage people to use
international units and not try to convert NAT detectable
units into international units because this ratio is very
dependent on the type of assay that is used.
[Slide]
Having said that, I can give you some figures and
you can see, for example, that for hepatitis C virus the
ratio differs between 3.3 to 8.3.  This is basically
because the assays differ in their sensitivity.  With
hepatitis B it is about 2.0 to 7.0  With HIV it is about
0.7 and B19 is about 0.628.  Ideally, we should have a
ratio of 1.0 to 1.0.  This doesn't work out.
[Slide]
The other aspect of the study is stability of the
international standards.  There are two ways of doing these
studies.  We can do real time stability studies and
accelerated degradation studies.  In accelerated
degradation studies vials of the sample are incubated at
different temperatures and then the quantity of virus is

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
measured to look for the degradation.  You can make some
assumptions to account for the stability of the material.
[Slide]
There are limitations to the stability studies.
We real time studies you can get changes in sensitivity of
the assays over time so that what we are measuring may not
reflect degradation but reflect the increase in sensitivity
of the assay over a period of years.  There is low
individual assay precision and the time scale is probably
longer than the shelf life of the sample.
Accelerated degradation studies also have their
problems.  At high temperatures of storage, where you get
reliable data for working out the degradation, you can
often get difficulties in reconstitution of the material,
and reliable estimates are difficult to work out.
[Slide]
If we look at the hepatitis C international
standard, we did some accelerated degradation studies on
this and showed that there was no loss of titer for samples
stored at 20 degrees for about 200 days.  Working through
some calculations, which I won't go through, this equates
to stability of the material for over two years at zero
degrees and below, and we store all international standards
at minus 20 degrees.
[Slide]

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
I also have real-time data on the international
standard and this is because we have done three studies, in
1997, to establish the international standard, and two
calibration studies for working reagents and genotypes, in
1998 and 2000.  I think it is obvious that the titers of
the sample in not detectable units per milliliter for
qualitative assays really hasn't changed very time over
four years, and the same for the assays, which are the
quantitative assays given genome equivalents per
milliliter, are around 5.8.  So, I think these are real-
time data on the stability of the hepatitis C international
standard.
[Slide]
The other thing that we need to consider is
replacing the international standard because although the
standard is supposed to last five to ten years, we have
practically run out of the standard already, and this is
because of the high usage because of the regulations in
Europe, and we have very few vials remaining of the
standard.
In the original study we had a second material,
B, which was also calibrated.  At the SOGAT meeting, which
is a WHO working group, we decided to replace the existing
standard with this material, B.  We are going to do that by
looking at the stability of the second material against the

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
existing standard in a series of degradation experiments,
basically to show that the titer of the second material
which has been stored at minus 20 is equivalent to the
first material.
[Slide]
The other thing that we have done is to calibrate
working reagents against the international standard.  In an
ideal world we should first establish an international
standard and then make secondary reagents from this.  But,
in fact, with hepatitis C and HIV-1 working reagents were
established long before the international standards and it
was necessary to calibrate these working reagents against
the international standards.
[Slide]
With hepatitis C, we have calibrated four
genotype-1 reagents and one genotype-3 reagents against the
standard, and that has been published.  With HIV-1, we have
calibrated working reagents, 7 type B reagents against the
international standard.  The preliminary results are being
completed, and I think the study is about to be published.
So, we have all the commonly used working reagents at the
moment which are calibrated in international units per
milliliter, which makes comparison of results and any sort
of legislation that is brought in much easier I think.

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
The other study we have done is to calibrate
genotypes or subtypes of HCV and HIV against the
international standards.  The C international standard is a
genotype 1A and the HIV-1 international standard is a
genotype B.  There is an argument saying that is it
possible to calibrate genotypes 2 to 6 against the
international standard and these subtypes A to H, N and O
against the HIV-1 international standard?
We have completed the analysis of this study and
this study is currently under way.  I will show you some
results for this study which has been completed in the next
few slides.
[Slide]
This is to illustrate the way that we analyze the
results.  We send out panels to laboratories and then work
out the titer of the samples, and have this sort of chart.
This gives the number of the lab and the titer of the virus
determined by the lab.  These are just the different types
of assays, Amplicor, TMA, in-house single loop, in-house
nested.  I think it is obvious that most of them cluster
around.  There are no sort of outliers, which I think is
good news.
[Slide]

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
These are examples of the Amplicor assay, which
is the quantitative Amplicor assay calibrated in
international units per milliliter.
[Slide]
These are the results of the qualitative assays
in not detectable units per milliliter, and the monitor
assays in international units per milliliter.  Again there
is very little difference between these figures.
[Slide]
This, again, is an illustration of the genotype 2
sample.  Again, most of the laboratories get the same sort
of figure.
[Slide]
In this table I will show you the calibration of
the genotypes against the international standards.  What we
have done is we have compared the titers of these materials
against the international standard and got a figure in
international units per milliliter.  So, for genotype 2,
which is that figure, it has approximately 10 international
4
units per milliliter and genotype 6 has approximately 10
4.65
international units per milliliter.
[Slide]
There are several conclusions we can draw from
this study.  The majority of participants in this study
used the Amplicor assay and I am afraid there was

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
insufficient representation of other assay types to allow
full assessment.  So, I guess the overall means are biased
towards the Amplicor assay.
[Slide]
We now have a panel of genotypes which are
available for use.  Although we haven't got an official
calibration yet, we have calibrated them in international
units per milliliter and the data, I hope, will be
published fully.
[Slide]
We have got valuable information on the
performance of assays across the genotypes and the
definitive assessment really needs to be done by using more
assays with the B DNA and TMA.  We have had only one
laboratory doing the B DNA assay and three doing the TMA in
the study.
[Slide]
I will briefly go on to quality assurance.
Quality assurance is defined as plans and systematic
activities implemented within a quality system.  Basically,
in quality we are looking for degree of excellence,
reliability, fitness of purpose, freedom from effects and
conformance to requirements.
[Slide]

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
Within NAT, in a NAT quality assurance program we
need to have access to good calibrated international
standards and working reagents which can be used in our
assays.  We need to calibrate genotype panels, which we


[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)]
[Notices]
[Pages 49674-49678]
[FR Doc No: 2016-17870]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0007]

Prescription Drug User Fee Rates for Fiscal Year 2017

AGENCY: Food and Drug Administration, HHS

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
for prescription drug user fees for fiscal year (FY) 2017. The Federal
Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the
Prescription Drug User Fee Amendments of 2012 (PDUFA V), authorizes FDA
to collect user fees for certain applications for the review of human
drug and biological products, on establishments where the products are
made, and on such products. This notice establishes the fee rates for
FY 2017.

FOR FURTHER INFORMATION CONTACT: Robert J. Marcarelli, Office of
Financial Management, Food and Drug Administration, 8455 Colesville
Rd., COLE-14202F, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 735 and 736 of the FD&C Act (21 U.S.C. 379g and 379h,
respectively) establish three different kinds of user fees. Fees are
assessed on the following: (1) Certain types of applications and
supplements for the review of human drug and biological products; (2)
certain establishments where such products are made; and (3) certain
products (section 736(a) of the FD&C Act). When certain conditions are
met, FDA may waive or reduce fees (section 736(d) of the FD&C Act).
    For FY 2013 through FY 2017, the base revenue amounts for the total
revenues from all PDUFA fees are established by PDUFA V. The base
revenue amount for FY 2013, which became the base amount for the
remaining four FYs of PDUFA V, is $718,669,000, as published in the
Federal Register of August 1, 2012 (77 FR 45639). The FY 2013 base
revenue amount is further adjusted each year after FY 2013 for
inflation and workload. For FY 2017, fee revenue and fees may be
further adjusted by the final year adjustment. In addition, for FY
2017, excess collections are offset as required by the FD&C Act. Fees
for applications, establishments, and products are to be established
each year

by FDA so that revenues from each category will provide one-third of
the total revenue to be collected each year.
    This document provides fee rates for FY 2017 for an application
requiring clinical data ($2,038,100), for an application not requiring
clinical data or a supplement requiring clinical data ($1,019,050), for
an establishment ($512,200), and for a product ($97,750). These fees
are effective on October 1, 2016, and will remain in effect through
September 30, 2017. For applications and supplements that are submitted
on or after October 1, 2016, the new fee schedule must be used.
Invoices for establishment and product fees for FY 2017 will be issued
in August 2016 using the new fee schedule.

II. Fee Revenue Amount for FY 2017

    The base revenue amount for FY 2017 is $718,669,000 prior to
adjustments for inflation, workload, the offset of excess collections,
and the final year adjustment (see sections 736(c)(1), 736(c)(2),
736(g)(4), and 736(c)(3) of the FD&C Act, respectively).

A. FY 2017 Statutory Fee Revenue Adjustments for Inflation

    PDUFA V specifies that the $718,669,000 is to be further adjusted
for inflation increases for FY 2017 using two separate adjustments--one
for personnel compensation and benefits (PC&B) and one for non-PC&B
costs (see section 736(c)(1) of the FD&C Act).
    The component of the inflation adjustment for payroll costs shall
be one plus the average annual percent change in the cost of all PC&B
paid per full-time equivalent (FTE) position at FDA for the first three
of the preceding four FYs, multiplied by the proportion of PC&B costs
to total FDA costs of process for the review of human drug applications
for the first three of the preceding four FYs (see section 736(c)(1)(A)
and (c)(1)(B) of the FD&C Act).
    Table 1 summarizes that actual cost and FTE data for the specified
FYs, and provides the percent changes from the previous FYs and the
average percent changes over the first three of the four FYs preceding
FY 2017. The 3-year average is 1.8759 percent.

              Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Changes
----------------------------------------------------------------------------------------------------------------
             Fiscal year                     2013               2014               2015          3-year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..........................     $1,927,703,000     $2,054,937,000     $2,232,304,000  .................
Total FTE...........................             13,974             14,555             15,484  .................
PC&B per FTE........................           $137,949           $141,184           $144,168  .................
Percent Change From Previous Year...             1.1690             2.3451             2.1136             1.8759
----------------------------------------------------------------------------------------------------------------

    The statute specifies that this 1.8759 percent should be multiplied
by the proportion of PC&B costs to total FDA costs of the process for
the review of human drug applications. Table 2 shows the PC&B and the
total obligations for the process for the review of human drug
applications for three FYs.

    Table 2--PC&B as a Percent of Fee Revenues Spent on the Process for the Review of Human Drug Applications
----------------------------------------------------------------------------------------------------------------
             Fiscal year                     2013               2014               2015          3-year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..........................       $568,206,210       $585,260,720       $615,483,892  .................
Total Costs.........................       $966,169,007     $1,077,263,695     $1,127,664,528  .................
PC&B Percent........................            58.8102            54.3285            54.5804            55.9064
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 1.8759 percent from table 1 multiplied by
55.9064 percent (or 1.0487 percent).
    The statute specifies that the portion of the inflation adjustment
for non-payroll costs is the average annual percent change that
occurred in the Consumer Price Index (CPI) for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items;
annual index) for the first three years of the preceding four years of
available data multiplied by the proportion of all costs other than
PC&B costs to total costs of the process for the review of human drug
applications for the first three years of the preceding four FYs (see
section 736(c)(1)(C) of the FD&C Act). Table 3 provides the summary
data for the percent changes in the specified CPI for the Washington-
Baltimore area. The data are published by the Bureau of Labor
Statistics and can be found on its Web site at: http://data.bls.gov/cgi-bin/surveymost?cu. The data can be viewed by checking the box
marked ``Washington-Baltimore All Items, November 1996=100--
CUURA311SA0'' and then selecting ``Retrieve Data''.

             Table 3--Annual and 3-Year Average Percent Change in CPI for Washington-Baltimore Area
----------------------------------------------------------------------------------------------------------------
                Year                         2013               2014               2015          3-year average
----------------------------------------------------------------------------------------------------------------
Annual CPI..........................            152.500            154.847            155.353  .................
Annual Percent Change...............             1.5232             1.5390             0.3268             1.1297
----------------------------------------------------------------------------------------------------------------

    To calculate the inflation adjustment for non-payroll costs, we
multiply the 1.1297 percent by the proportion of all costs other than
PC&B to total costs of the process for the review of human drug
applications obligated. Since 55.9064 percent was obligated for PC&B as
shown in Table 2, 44.0936 percent is the portion of costs other than
PC&B (100 percent minus 55.9064 percent equals 44.0936 percent). The
non-payroll adjustment is 1.1297 percent times 44.0936 percent, or
0.4981 percent.
    Next, we add the payroll adjustment (1.0487 percent) to the non-
payroll adjustment (0.4981 percent), for a total

inflation adjustment of 1.5468 percent (rounded) for FY 2017.
    PDUFA V provides for this inflation adjustment to be compounded
after FY 2013 (see section 736(c)(1) of the FD&C Act). This factor for
FY 2017 (1.5468 percent) is compounded by adding one and then
multiplying by one plus the compound inflation adjustment factor for FY
2016 (6.4414 percent), as published in the Federal Register of August
3, 2015 (80 FR 46028 at 46032), which equals to 1.080878 (rounded)
(1.015468 x 1.064414) for FY 2017. We then multiply the base revenue
amount for FY 2017 ($718,669,000) by 1.080878, yielding an inflation-
adjusted amount of $776,793,511.

B. FY 2017 Statutory Fee Revenue Adjustments for Workload

    The statute specifies that after the $718,669,000 has been adjusted
for inflation, the inflation-adjusted amount shall be further adjusted
for workload (see section 736(c)(2) of the FD&C Act).
    To calculate the FY 2017 workload adjustment, FDA calculated the
average number of each of the four types of applications specified in
the workload adjustment provision: (1) Human drug applications; (2)
active commercial investigational new drug applications (INDs)
(applications that have at least one submission during the previous 12
months); (3) efficacy supplements; and (4) manufacturing supplements
received over the 3-year period that ended on June 30, 2012 (base
years), and the average number of each of these types of applications
over the most recent 3-year period that ended June 30, 2016.
    The calculations are summarized in table 4. The 3-year averages for
each application category are provided in column 1 (``3-Year Average
Base Years 2010-2012'') and column 2 (``3-Year Average 2014-2016'').
Column 3 reflects the percent change in workload from column 1 to
column 2. Column 4 shows the weighting factor for each type of
application, estimating how much of the total FDA drug review workload
was accounted for by each type of application in the table during the
most recent 3 years. Column 5 is the weighted percent change in each
category of workload. This was derived by multiplying the weighting
factor in each line in column 4 by the percent change from the base
years in column 3. The values in column 5 are summed, reflecting an
increase in workload of 13.1047 percent (rounded) for FY 2017 when
compared to the base years.

                               Table 4--Workload Adjuster Calculation for FY 2017
----------------------------------------------------------------------------------------------------------------
                                     Column 1        Column 2        Column 3        Column 4        Column 5
                                 -------------------------------------------------------------------------------
        Application type          3-year average                  Percent change     Weighting
                                    base years    3-year average   (column 1 to       factor         Weighted
                                     2010-2012       2014-2016       column 2)       (percent)    percent change
----------------------------------------------------------------------------------------------------------------
New Drug Applications/Biologics         124.3000        147.3000         18.5036         35.8514          6.6338
 License Applications...........
Active Commercial INDs..........       6830.0000       7598.0000         11.2445         41.0966          4.6211
Efficacy Supplements............        136.3000        196.3000         44.0205          6.8122          2.9988
Manufacturing Supplements.......       2548.3000       2368.0000         -7.0753         16.2399         -1.1490
                                 -------------------------------------------------------------------------------
    FY 2017 Workload Adjuster...  ..............  ..............  ..............  ..............         13.1047
----------------------------------------------------------------------------------------------------------------

    Table 5 shows the calculation of the inflation and workload
adjusted amount for FY 2017. The $718,669,000 subject to adjustment on
line 1 is multiplied by the inflation adjustment factor of 1.080878,
resulting in the inflation-adjusted amount on line 3, $776,793,511.
That amount is then multiplied by one plus the workload adjustment of
13.1047 percent on line 4, resulting in the inflation and workload
adjusted amount of $878,590,000 on line 5, rounded to the nearest
thousand dollars.

   Table 5--PDUFA Inflation and Workload Adjusted Amount for FY 2017,
                           Summary Calculation
------------------------------------------------------------------------

------------------------------------------------------------------------
FY 2013 Revenue Amount and Base           $718,669,000  Line 1.
 Subsequent FYs as published in the
 Federal Register of August 1, 2012
 (77 FR 45639) (rounded to nearest
 thousand dollars).
Inflation Adjustment Factor for FY            1.080878  Line 2.
 2017 (1 plus 8.0878 percent).
Inflation Adjusted Amount..........       $776,793,511  Line 3.
Workload Adjustment Factor for FY             1.131047  Line 4.
 2017 (1 plus 13.1047 percent).
Inflation and Workload Adjusted           $878,590,000  Line 5.
 Amount (rounded to nearest
 thousand dollars).
------------------------------------------------------------------------

III. Offset for Excess Collections Through FY 2016

    Under the provisions of the FD&C Act, if the sum of the cumulative
amount of the fees collected for FY 2013 through 2015, and the amount
of fees estimated to be collected under this section for FY 2016,
exceeds the cumulative amount appropriated for fees for FYs 2013
through 2016, the excess shall be credited to FDA's appropriation
account and subtracted from the amount of fees that FDA would otherwise
be authorized to collect for FY 2017 under the FD&C Act (see section
736(g)(4) of the FD&C Act as amended by PDUFA V).
    Table 6 shows the amounts specified in appropriation acts for each
year from FY 2013 through FY 2016, and the amounts FDA has collected
for FYs 2013, 2014, and 2015 as of June 30, 2016, and an additional
$70,907,000 (rounded to the nearest thousand dollars) that FDA
estimates it will collect in FY 2016 based on historical data. Table 6
shows the estimated cumulative difference between PDUFA fee amounts
specified in appropriation acts for FY 2013 through FY 2016 and PDUFA
fee amounts collected.

                                    Table 6--Offsets To Be Taken for PDUFA V
----------------------------------------------------------------------------------------------------------------
                                                                                Amount in excess
                                                                            Collection amount    of collection
                      Fiscal year                           Collections        specified in     amount specified
                                                            realized ($)      appropriation     in appropriation
                                                                                acts ($)           acts ($)
----------------------------------------------------------------------------------------------------------------
2013...................................................        721,224,494        718,669,000          2,555,494
2014...................................................        805,856,366        760,000,000         45,856,366
2015...................................................        852,746,867        798,000,000         54,746,867
2016...................................................        872,388,000        851,481,000         20,907,000
                                                        --------------------------------------------------------
    Net Balance to be Offset When Fees are Set for FY    .................  .................        124,065,726
     2017..............................................
----------------------------------------------------------------------------------------------------------------
Note: FY 2016 `Collections Realized' is the amount FDA estimates it will collect in FY 2016 based on historical
  data.

    The cumulative fees collected for FYs 2013 through 2016 are
estimated to be $124,065,726 greater than the cumulative fee amounts
specified in appropriation acts during this same period. Reducing the
inflation and workload adjusted amount of $878,590,000 by the PDUFA V
offset of $124,066,000 (rounded to the nearest thousand dollars)
results in an amount of $754,524,000, before the final year adjustment.

IV. Final Year Adjustment

    Under the provisions of the FD&C Act, as amended, for FY 2017 the
Secretary of Health and Human Services may, in addition to the
inflation and workload adjustments, further increase the fees and fee
revenues if such an adjustment is necessary to provide for not more
than 3 months of operating reserves of carryover user fees for the
process for the review of human drug applications for the first 3
months of FY 2018. If such an adjustment is necessary, the rationale
for the amount of this increase shall be contained in the annual notice
establishing fee revenues and fees for FY 2017 (see section 736(c)(3)
of the FD&C Act).
    After running analyses on the status of PDUFA's operating reserves
and its estimated balance as of the beginning of FY 2018, FDA estimates
that the PDUFA program will have sufficient funds for the operating
reserves, thus FDA will not be performing a final year adjustment for
FY 2018 because FDA has determined such an adjustment to be
unnecessary.
    The FD&C Act specifies that one-third of the total fee revenue is
to be derived from application fees, one-third from establishment fees,
and one-third from product fees (see section 736(b)(2) of the FD&C
Act). Accordingly, one-third of the total revenue amount
($754,524,000), or a total of $251,508,000, is the amount of fee
revenue that will be derived from each fee type: Application fees,
establishment fees, and product fees.

V. Application Fee Calculations

A. Application Fee Revenues and Application Fees

    Application fees will be set to generate one-third of the total fee
revenue amount, or $251,508,000 in FY 2017.

B. Estimate of the Number of Fee-Paying Applications and Setting the
Application Fees

    For FY 2013 through FY 2017, FDA will estimate the total number of
fee-paying full application equivalents (FAEs) it expects to receive
the next FY by averaging the number of fee-paying FAEs received in the
three most recently completed FYs. Beginning with FY 2016, prior year
FAE totals will be updated annually to reflect refunds and waivers
processed after the close of the FY.
    In estimating the number of fee-paying FAEs, a full application
requiring clinical data counts as one FAE. An application not requiring
clinical data counts as one-half of an FAE, as does a supplement
requiring clinical data. An application that is withdrawn, or refused
for filing, counts as one-fourth of an FAE if the applicant initially
paid a full application fee, or one-eighth of an FAE if the applicant
initially paid one-half of the full application fee amount.
    As Table 7 shows, the average number of fee-paying FAEs received
annually in the most recent 3-year period is 123.405 FAEs. FDA will set
fees for FY 2017 based on this estimate as the number of full
application equivalents that will pay fees.

                                            Table 7--Fee-Paying FAEs
----------------------------------------------------------------------------------------------------------------
                     FY                             2013             2014             2015        3-year average
----------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs.............................         109.010          128.750          132.456          123.405
----------------------------------------------------------------------------------------------------------------
Note: Beginning with FY 2016, prior year FAE totals will be updated annually to reflect refunds and waivers
  processed after the close of the FY.

    The FY 2017 application fee is estimated by dividing the average
number of full applications that paid fees over the latest 3 years,
123.405, into the fee revenue amount to be derived from application
fees in FY 2017, $251,508,000. The result, rounded to the nearest
hundred dollars, is a fee of $2,038,100 per full application requiring
clinical data, and $1,019,050 per application not requiring clinical
data or per supplement requiring clinical data.

VI. Fee Calculations for Establishment and Product Fees

A. Establishment Fees

    At the beginning of FY 2016, the establishment fee was based on an
estimate that 485 establishments would be subject to and would pay
fees. By the

end of FY 2016, FDA estimates that 523 establishments will have been
billed for establishment fees, before all decisions on requests for
waivers or reductions are made. FDA estimates that a total of 16
establishment fee waivers or reductions will be made for FY 2016. In
addition, FDA estimates that another 16 full establishment fees will be
exempted this year based on the orphan drug exemption in section 736(k)
of the FD&C Act. Subtracting 32 establishments (16 waivers, plus the
estimated 16 establishments under the orphan exemption) from 523 leaves
a net of 491 fee-paying establishments. FDA will use 491 to estimate
the FY 2017 establishments paying fees. The fee per establishment is
determined by dividing the adjusted total fee revenue to be derived
from establishments ($251,508,000) by the estimated 491 establishments,
for an establishment fee rate for FY 2017 of $512,200 (rounded to the
nearest hundred dollars).

B. Product Fees

    At the beginning of FY 2016, the product fee was based on an
estimate that 2,480 products would be subject to and would pay product
fees. By the end of FY 2016, FDA estimates that 2,646 products will
have been billed for product fees, before all decisions on requests for
waivers, reductions, or exemptions are made. FDA assumes that there
will be 41 waivers and reductions granted. In addition, FDA estimates
that another 32 product fees will be exempted this year based on the
orphan drug exemption in section 736(k) of the FD&C Act. FDA estimates
that 2,573 products will qualify for and pay product fees in FY 2016,
after allowing for an estimated 73 waivers and reductions, including
the orphan drug products, and will use this number for its FY 2017
estimate. The FY 2017 product fee rate is determined by dividing the
adjusted total fee revenue to be derived from product fees
($251,508,000) by the estimated 2,573 products for a FY 2017 product
fee of $97,750 (rounded to the nearest ten dollars).

VII. Fee Schedule for FY 2017

    The fee rates for FY 2017 are displayed in table 8:

                    Table 8--Fee Schedule for FY 2017
------------------------------------------------------------------------
                                                               Fee rates
                        Fee category                            for FY
                                                               2017 ($)
------------------------------------------------------------------------
Applications:
  Requiring clinical data...................................   2,038,100
  Not requiring clinical data...............................   1,019,050
  Supplements requiring clinical data.......................   1,019,050
Establishments..............................................     512,200
Products....................................................      97,750
------------------------------------------------------------------------

VIII. Fee Payment Options and Procedures

A. Application Fees

    The appropriate application fee established in the new fee schedule
must be paid for any application or supplement subject to fees under
PDUFA that is received on or after October 1, 2016. Payment must be
made in U.S. currency by electronic check, check, bank draft, wire
transfer, or U.S. postal money order payable to the order of the Food
and Drug Administration. The preferred payment method is online using
electronic check (Automated Clearing House (ACH) also known as eCheck)
or credit card (Discover, VISA, MasterCard, American Express). Secure
electronic payments can be submitted using the User Fees Payment Portal
at https://userfees.fda.gov/pay. Once you search for your invoice,
click ``Pay Now'' to be redirected to Pay.gov. Note that electronic
payment options are based on the balance due. Payment by credit card is
available for balances less than $25,000. If the balance exceeds this
amount, only the ACH option is available. Payments must be drawn on U.S
bank accounts as well as U.S. credit cards.
    FDA has partnered with the U.S. Department of the Treasury to use
Pay.gov, a Web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA Web site after the
user fee ID number is generated.
    Please include the user fee identification (ID) number on your
check, bank draft, or postal money order. Your payment can be mailed
to: Food and Drug Administration, P.O. Box 979107, St. Louis, MO 63197-
9000.
    If checks are to be sent by a courier that requests a street
address, the courier can deliver the checks to: U.S. Bank, Attention:
Government Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101.
(Note: This U.S. Bank address is for courier delivery only. If you have
any questions concerning courier delivery contact the U.S. Bank at 314-
418-4013. This telephone number is only for questions about courier
delivery).
    Please make sure that the FDA post office box number (P.O. Box
979107) is written on the check, bank draft, or postal money order.
    If paying by wire transfer, please reference your unique user fee
ID number when completing your transfer. The originating financial
institution may charge a wire transfer fee. Please ask your financial
institution about the fee and add it to your payment to ensure that
your fee is fully paid. The account information for wire transfers is
as follows: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, Acct. No.: 75060099, Routing No.: 021030004, SWIFT:
FRNYUS33, Beneficiary: FDA, 8455 Colesville Rd., 14th Floor, Silver
Spring, MD 20993-0002.
    The tax identification number of FDA is 53-0196965.

B. Establishment and Product Fees

    FDA will issue invoices for establishment and product fees for FY
2017 under the new fee schedule in August 2016. Payment will be due on
October 1, 2016. FDA will issue invoices in November 2017 for any
products and establishments subject to fees for FY 2017 that qualify
for fee assessments after the August 2016 billing.

    Dated: July 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17870 Filed 7-27-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: September 14, 2010 (Volume 75, Number 177)]
[Rules and Regulations]
[Page 55683-55686]
[DOCID:fr14se10-7]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2010-0003; Internal Agency Docket No. FEMA-8149]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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

SUMMARY: This rule identifies communities, where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP), that are scheduled for suspension on the effective
dates listed within this rule because of noncompliance with the
floodplain management requirements of the program. If the Federal
Emergency Management Agency (FEMA) receives documentation that the
community has adopted the required floodplain management measures prior
to the effective suspension date given in this rule, the suspension
will not occur and a notice of this will be provided by publication in
the Federal Register on a subsequent date.

DATES: Effective Dates: The effective date of each community's
scheduled suspension is the third date (``Susp.'') listed in the third
column of the following tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact David Stearrett, Mitigation Directorate,
Federal Emergency Management Agency, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
flood insurance which is generally not otherwise available. In return,
communities agree to adopt and administer local floodplain management
aimed at protecting lives and new construction from future flooding.
Section 1315 of the National Flood Insurance Act of 1968, as amended,
42 U.S.C. 4022, prohibits flood insurance coverage as authorized under
the NFIP, 42 U.S.C. 4001 et seq.; unless an appropriate public body
adopts adequate floodplain management measures with effective
enforcement measures. The communities listed in this document no longer
meet that statutory requirement for compliance with program
regulations, 44 CFR part 59. Accordingly, the communities will

be suspended on the effective date in the third column. As of that
date, flood insurance will no longer be available in the community.
However, some of these communities may adopt and submit the required
documentation of legally enforceable floodplain management measures
after this rule is published but prior to the actual suspension date.
These communities will not be suspended and will continue their
eligibility for the sale of insurance. A notice withdrawing the
suspension of the communities will be published in the Federal
Register.
    In addition, FEMA has identified the Special Flood Hazard Areas
(SFHAs) in these communities by publishing a Flood Insurance Rate Map
(FIRM). The date of the FIRM, if one has been published, is indicated
in the fourth column of the table. No direct Federal financial
assistance (except assistance pursuant to the Robert T. Stafford
Disaster Relief and Emergency Assistance Act not in connection with a
flood) may legally be provided for construction or acquisition of
buildings in identified SFHAs for communities not participating in the
NFIP and identified for more than a year, on FEMA's initial flood
insurance map of the community as having flood-prone areas (section
202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a),
as amended). This prohibition against certain types of Federal
assistance becomes effective for the communities listed on the date
shown in the last column. The Administrator finds that notice and
public comment under 5 U.S.C. 553(b) are impracticable and unnecessary
because communities listed in this final rule have been adequately
notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. This rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Considerations. No environmental impact assessment has been prepared.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended, 42
U.S.C. 4022, prohibits flood insurance coverage unless an appropriate
public body adopts adequate floodplain management measures with
effective enforcement measures. The communities listed no longer comply
with the statutory requirements, and after the effective date, flood
insurance will no longer be available in the communities unless
remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

0
Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for part 64 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                 Effective date
                                                 authorization/
                                   Community    cancellation of    Current effective map   Date certain Federal
       State and location             No.        sale of flood             date            assistance no longer
                                                  insurance in                              available in SFHAs
                                                   community
----------------------------------------------------------------------------------------------------------------
            Region V

Wisconsin:
    Gillett, City of, Oconto           550295  September 30,      October 6, 2010.......  October 6, 2010
     County.                                    1975, Emerg;
                                                February 1,
                                                1984, Reg;
                                                October 6, 2010,
                                                Susp.
    Lena, Village of, Oconto           550296  July 7, 1975,      ......do..............   Do.
     County.                                    Emerg; September
                                                18, 1985, Reg;
                                                October 6, 2010,
                                                Susp.
    Oconto, City of, Oconto            550297  September 17,      ......do..............   Do.
     County.                                    1973, Emerg;
                                                August 3, 1981,
                                                Reg; October 6,
                                                2010, Susp.
    Oconto County,                     550294  May 21, 1973,      ......do..............   Do.
     Unincorporated Areas.                      Emerg; January
                                                6, 1983, Reg;
                                                October 6, 2010,
                                                Susp.
    Oconto Falls, City of,             550298  June 23, 1975,     ......do..............   Do.
     Oconto County.                             Emerg; July 16,
                                                1981, Reg;
                                                October 6, 2010,
                                                Susp.
    Pulaski, Village of, Brown,        550024  February 27,       ......do..............   Do.
     Oconto, and Shawano                        1976, Emerg;
     Counties.                                  August 3, 1981,
                                                Reg; October 6,
                                                2010, Susp.
    Suring, Village of, Oconto         550300  January 30, 1975,  ......do..............   Do.
     County.                                    Emerg; December
                                                1, 1983, Reg;
                                                October 6, 2010,
                                                Susp.
           Region VI

Arkansas:
    Elaine, City of, Phillips          050167  March 29, 1974,    ......do..............   Do.
     County.                                    Emerg; September
                                                4, 1985, Reg;
                                                October 6, 2010,
                                                Susp.
    Helena-West Helena, City           050168  February 15,       ......do..............   Do.
     of, Phillips County.                       1974, Emerg;
                                                July 16, 1979,
                                                Reg; October 6,
                                                2010, Susp.
    Lake View, City of,                050169  July 23, 1976,     ......do..............   Do.
     Phillips County.                           Emerg; February
                                                1, 1987, Reg;
                                                October 6, 2010,
                                                Susp.
    Marvell, City of, Phillips         050170  July 28, 1993,     ......do..............   Do.
     County.                                    Emerg; August 1,
                                                2008, Reg;
                                                October 6, 2010,
                                                Susp.

    Phillips County,                   050166  April 28, 1981,    ......do..............   Do.
     Unincorporated Areas..                     Emerg; April 1,
                                                1988, Reg;
                                                October 6, 2010,
                                                Susp.
New Mexico:
    Portales, City of,                 350054  October 29, 1974,  ......do..............   Do.
     Roosevelt County.                          Emerg; January
                                                20, 1982, Reg;
                                                October 6, 2010,
                                                Susp.
    Red River, Town of, Taos           350079  April 18, 1975,    ......do..............   Do.
     County.                                    Emerg; July 1,
                                                1987, Reg;
                                                October 6, 2010,
                                                Susp.
    Taos, Town of, Taos County.        350080  August 25, 1975,   ......do..............   Do.
                                                Emerg; August 4,
                                                1987, Reg;
                                                October 6, 2010,
                                                Susp.
    Taos County, Unincorporated        350078  September 25,      ......do..............   Do.
     Areas.                                     1975, Emerg;
                                                January 5, 1989,
                                                Reg; October 6,
                                                2010, Susp.
Texas:
    Big Spring, City of, Howard        480360  February 7, 1975,  ......do..............   Do.
     County.                                    Emerg; September
                                                30, 1981, Reg;
                                                October 6, 2010,
                                                Susp.
    Brooks County,                     481196  July 21, 1975,     ......do..............   Do.
     Unincorporated Areas.                      Emerg; July 1,
                                                1987, Reg;
                                                October 6, 2010,
                                                Susp.
    Coahoma, City of, Howard           481099  September 13,      ......do..............   Do.
     County.                                    2007, Emerg;
                                                October 6, 2010,
                                                Reg; October 6,
                                                2010, Susp.
    Falfurrias, City of, Brooks        480086  March 21, 1975,    ......do..............   Do.
     County.                                    Emerg; August
                                                17, 1981, Reg;
                                                October 6, 2010,
                                                Susp.
    Howard County,                     481227  June 3, 1982,      ......do..............   Do.
     Unincorporated Areas.                      Emerg; February
                                                1, 1988, Reg;
                                                October 6, 2010,
                                                Susp.
    Kountze, City of, Hardin           480845  February 27,       ......do..............   Do.
     County.                                    1987, Emerg;
                                                November 1,
                                                1989, Reg;
                                                October 6, 2010,
                                                Susp.
    Lumberton, City of, Hardin         481111  May 8, 1979,       ......do..............   Do.
     County.                                    Emerg; May 8,
                                                1979, Reg;
                                                October 6, 2010,
                                                Susp.
    Rose Hill Acres, City of,          480846  March 8, 1974,     ......do..............   Do.
     Hardin County.                             Emerg; April 15,
                                                1977, Reg;
                                                October 6, 2010,
                                                Susp.
    Silsbee, City of, Hardin           480285  June 7, 1974,      ......do..............   Do.
     County.                                    Emerg; May 1,
                                                1978, Reg;
                                                October 6, 2010,
                                                Susp.
    Sour Lake, City of, Hardin         480286  June 3, 1974,      ......do..............   Do.
     County.                                    Emerg; October
                                                28, 1977, Reg;
                                                October 6, 2010,
                                                Susp.
           Region VII

Iowa:
    Earlham, City of, Madison          190570  September 6,       ......do..............   Do.
     County.                                    1977, Emerg;
                                                September 30,
                                                1988, Reg;
                                                October 6, 2010,
                                                Susp.
    East Peru, City of, Madison        190450  April 25, 1977,    ......do..............   Do.
     County.                                    Emerg; February
                                                1, 1987, Reg;
                                                October 6, 2010,
                                                Susp.
    Madison County,                    190887  September 10,      ......do..............   Do.
     Unincorporated Areas.                      1993, Emerg;
                                                September 1,
                                                1996, Reg;
                                                October 6, 2010,
                                                Susp.
    Patterson, City of, Madison        190451  March 27, 1979,    ......do..............   Do.
     County.                                    Emerg; January
                                                1, 1987, Reg;
                                                October 6, 2010,
                                                Susp.
    Winterset, City of, Madison        190944  April 24, 1992,    ......do..............   Do.
     County.                                    Emerg; May 3,
                                                1993, Reg;
                                                October 6, 2010,
                                                Susp.
    Kansas: Harvey County,             200585  October 19, 1978,  ......do..............   Do.
     Unincorporated Areas.                      Emerg; August
                                                15, 1983, Reg;
                                                October 6, 2010,
                                                Susp.
    Newton, City of, Harvey            200133  September 13,      ......do..............   Do.
     County.                                    1974, Emerg;
                                                October 2, 1979,
                                                Reg; October 6,
                                                2010, Susp.
    North Newton, City of,             200542  June 28, 1979,     ......do..............   Do.
     Harvey County.                             Emerg; June 28,
                                                1979, Reg;
                                                October 6, 2010,
                                                Susp.
          Region VIII

Utah:
    Uintah County,                     490147  November 30,       ......do..............   Do.
     Unincorporated Areas.                      1977, Emerg;
                                                February 1,
                                                1986, Reg;
                                                October 6, 2010,
                                                Susp.
    Vernal, City of, Uintah            490149  April 16, 1975,    ......do..............   Do.
     County.                                    Emerg; March 18,
                                                1986, Reg;
                                                October 6, 2010,
                                                Susp.
----------------------------------------------------------------------------------------------------------------
*-do- =Ditto.
Code for reading third column: Emerg. --Emergency; Reg. --Regular; Susp. --Suspension.

    Dated: September 3, 2010.
Edward L. Connor,
Acting Federal Insurance and Mitigation Administrator, Department of
Homeland Security, Federal Emergency Management Agency.
[FR Doc. 2010-22796 Filed 9-13-10; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 80, Number 213 (Wednesday, November 4, 2015)]
[Notices]
[Pages 68376-68377]
[FR Doc No: 2015-28019]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76294; File No. SR-NYSEMKT-2015-83]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Amending Rules 46--
Equities, 46A--Equities, 103B--Equities, and 497--Equities To Replace
References to the NYSE Regulation Board of Directors With the
Exchange's Regulatory Oversight Committee

October 29, 2015.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on October 19, 2015, NYSE MKT LLC (the ``Exchange'' or
``NYSE MKT'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Exchange has designated this proposal as a ``non-
controversial'' proposed rule change pursuant to Section 19(b)(3)(A) of
the Act \4\ and Rule 19b-4(f)(6)(iii) thereunder,\5\ which renders it
effective upon filing with the Commission. 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\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
    \4\ 15 U.S.C. 78s(b)(3)(A).
    \5\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

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

    The Exchange proposes to amend Rules 46--Equities, 46A--Equities,
103B--Equities, and 497--Equities to replace references to the NYSE
Regulation Board of Directors with the Exchange's Regulatory Oversight
Committee. The text of the proposed rule change is available on the
Exchange's Web site at www.nyse.com, at the principal office of the
Exchange, 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 self-regulatory organization
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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Rules 46--Equities, 46A--Equities,
103B--Equities, and 497--Equities to replace references to the NYSE
Regulation Board of Directors with the Exchange's Regulatory Oversight
Committee (``ROC'').
    The Exchange recently amended the Operating Agreement to, among
other things, establish a ROC.\6\ The Exchange now proposes the
following conforming amendments to Rules 46--Equities, 46A- Equities,
103B--Equities, and 497--Equities. These proposed changes, described
below, are similar to changes to the rules of the Exchange's affiliate,
NYSE, which were recently approved by the Commission.\7\
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 75148 (June 11,
2015), 80 FR 34751 (SR-NYSEMKT-2015-27) (approving creation of a ROC
with primary responsibility to independently monitor the exchange's
regulatory operations).
    \7\ See Securities Exchange Act Release No. 75991 (September 28,
2015), 80 FR 59837, 59839 (October 2, 2015) (SR-NYSE-2015-27).
---------------------------------------------------------------------------

    First, the Exchange proposes to amend Rule 46(b)--Equities, which
governs the appointment of Floor Officials, to replace the reference to
the ``NYSE Regulation Board of Directors'' with the ROC as the entity
with which the Board would consult on those appointments.
    Similarly, the Exchange proposes to amend Rule 46A--Equities, which
governs the appointment of Executive Floor Governors, to replace the
``Board of Directors of NYSE Regulation'' with the ROC as the entity
with which the Board would consult on those appointments.
    Third, Rule 103B--Equities, which governs the security allocation
and reallocation process, would be amended to replace ``NYSER Board of
Directors'' in subsection (b) of Supplementary Material .10 with the
``Exchange's Regulatory Oversight Committee''.
    Finally, Rule 497--Equities sets forth certain requirements that
securities issued by Intercontinental Exchange, Inc., or its affiliates
must meet before they can be listed on the Exchange. The Exchange
proposes to replace ``NYSE Regulation Board of Directors'' in Rule
497(b) and (c)(1) with ``Exchange's Regulatory Oversight Committee''.
The ROC is now the entity that approves regulatory findings that the
security to be listed satisfies Exchange listing rules under Rule
497(b) and that would receive the reports specified in Rule 497(c)--
Equities.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Exchange Act \8\ in general, and with Section
6(b)(5) \9\ in particular, in that it in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, and to
remove impediments to and perfect the mechanism of a free and open
market and a national market system and, in general, help to protect
investors and the public interest. Specifically, the Exchange believes
that replacing references to the NYSE Regulation Board of Directors
with the Exchange's ROC in Rules 46--Equities, 46A--Equities, 103B--
Equities, and 497--Equities removes impediments to and perfects the
mechanism of a free and open market by removing confusion that may
result from having obsolete references in the Exchange's rulebook. The
Exchange further believes that the proposal removes impediments to and
perfects the mechanism of a free and open market by ensuring that
persons

subject to the Exchange's jurisdiction, regulators, and the investing
public can more easily navigate and understand the Exchange's rulebook.
The Exchange believes that eliminating obsolete references would not be
inconsistent with the public interest and the protection of investors
because investors will not be harmed and in fact would benefit from
increased transparency, thereby reducing potential confusion. Removing
such obsolete references will also further the goal of transparency and
add clarity to the Exchange's rules.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Exchange Act. The proposed rule
change is not intended to address competitive issues but rather to
delete obsolete references, thereby increasing transparency, reducing
confusion, and making the Exchange's rules easier to understand and
navigate.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-4(f)(6)
thereunder.\10\
---------------------------------------------------------------------------

    \10\ In addition, Rule 19b-4(f)(6)(iii) requires the Exchange to
give the Commission written notice of the Exchange's intent to file
the proposed rule change, along with a brief description and text of
the proposed rule change, at least five business days prior to the
date of filing of the proposed rule change, or such shorter time as
designated by the Commission. The Exchange has satisfied this
requirement.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act normally does not become operative for 30 days after the date of
its filing. However, Rule 19b-4(f)(6)(iii) permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Commission believes
that waiver of the 30-day operative delay is appropriate because the
proposed rule change would replace references to NYSE Regulation Board
of Directors or NYSER Board of Directors with references to the
Exchange's Regulatory Oversight Committee and thus reflect recently
approved changes to the Exchange's Operating Agreement that established
the Exchange's Regulatory Oversight Committee.\11\ Based on the
foregoing, the Commission believes that the waiver of the operative
delay is consistent with the protection of investors and the public
interest.\12\ The Commission hereby grants the waiver and designates
the proposal operative upon filing.
---------------------------------------------------------------------------

    \11\ See supra note 6.
    \12\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    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 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-NYSEMKT-2015-83 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEMKT-2015-83. 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 20549-1090, on official business days between the hours
of 10:00 a.m. and 3:00 p.m. Copies of the filing will also be available
for inspection and copying at the NYSE's principal office and on its
Internet Web site at www.nyse.com. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSEMKT-2015-83 and should be submitted on or before
November 25, 2015.
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-28019 Filed 11-3-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: November 2, 2009 (Volume 74, Number 210)]
[Notices]
[Page 56598]
[DOCID:fr02no09-23]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12683-002]

Three Guys Hydroelectric Company, LLC; Notice of Preliminary
Permit Application Accepted for Filing and Soliciting Comments, Motions
To Intervene, and Competing Applications

October 23, 2009.
    On September 1, 2009, Three Guys Hydroelectric Company, LLC filed
an application for a successive preliminary permit, pursuant to section
4(f) of the Federal Power Act, proposing to study the feasibility of
the R. D. Bailey Dam Hydroelectric Project No. 12683, to be located at
the existing R. D. Bailey Dam, on the Guyandotte River, in Mingo
County, West Virginia. The sole purpose of a preliminary permit, if
issued, is to grant the permit holder priority to file a license
application during the permit term. A preliminary permit does not
authorize the permit holder to perform any land disturbing activities
or otherwise enter upon lands or waters owned by others without the
owners' express permission.
    The existing R. D. Bailey Dam is owned and operated by the U.S.
Corps of Engineers, and includes the existing reservoir, dam, outlet
works, and tailrace. The proposed project would consist of: (1) A new
60-foot-long by 40-foot-wide powerhouse to be located on the downstream
side of R. D. Bailey dam below the outlet works; (2) a new bifurcating
steel structure consisting of a 100-foot-long gated bypassed outlet and
a 150-foot-long, 11-foot-diameter penstock; (3) two new turbine
generator units for a total installed capacity of 7.8 megawatts; (4) a
new 6.5-mile-long, 14.7-kilovolt transmission line; and (5) appurtenant
facilities. The proposed project would operate in run-of-river mode and
generate an estimated average annual generation of 30,000 megawatt-
hours.
    Applicant Contact: Mr. M. Clifford Phillips, Advanced Hydro
Solutions LLC, 150 North Miller Road, Suite 450C, Fairlawn, OH 44333.
    FERC Contact: Michael Watts,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``eFiling'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the ``eLibrary'' link of Commission's Web site at http://
www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-
12683) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-26240 Filed 10-30-09; 8:45 am]

BILLING CODE 6717-01-P