 ADVANCE \y63

	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

	REGION III

1650 Arch Street

	Philadelphia, Pennsylvania  19103-2029

November 12, 2008

Mr. George S. Hawkins, Director

District of Columbia Department of the Environment

51 N Street, N.E., 6th Floor

Washington, DC  20002

Dear Mr. Hawkins:

On September 22, 2008, the U.S. Environmental Protection Agency (EPA)
received a revision to the District of Columbia’s State Implementation
Plan (SIP) from the District Department of the Environment (DDOE).  This
revision consists of Certification of Reasonably Available Control
Technology (RACT) State Implementation Plan under the 8-hour ozone
national ambient air quality standard (NAAQS).  EPA has determined that
the submittals are administratively and technically complete, and is
reviewing them to prepare a Notice of Proposed Rulemaking.

If members of your staff have any questions, they may direct them to
Patrick Egan at<PHONE_NUMBER>.  He is the principal contact for this
rulemaking.

	Sincerely,

 /s/

         Judith M. Katz, Director

                          			         Air Protection Division

	Customer Service Hotline: 1-800-438-2474


[Federal Register Volume 78, Number 119 (Thursday, June 20, 2013)]
[Notices]
[Page 37218]
[FR Doc No: 2013-14733]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP13-487-000]

Tennessee Gas Pipeline Company, L.L.C.; Notice of Request Under
Blanket Authorization

    Take notice that on May 30, 2013, Tennessee Gas Pipeline Company,
L.L.C. (Tennessee), 1001 Louisiana Street, Houston, Texas 77002, filed
a prior notice application pursuant to sections 157.205 and 157.216(b)
of the Federal Energy Regulatory Commission's (Commission) regulations
under the Natural Gas Act (NGA), and Tennessee's blanket certificate
issued in Docket No. CP82-413-000, to abandon in place and by removal
two redundant and obsolete pipeline segments that cross the Big Sandy
River north of Burnaugh, Kentucky, all as more fully set forth in the
application, which is open to the public for inspection. The filing may
also be viewed on the web at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC at<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or
TTY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
Thomas G. Joyce, Manager, Certificates & Compliance, Tennessee Gas
Pipeline Company, L.L.C, 1001 Louisiana Street, Houston, Texas 77002,
or telephone<PHONE_NUMBER> or fax<PHONE_NUMBER>or by email<EMAIL_ADDRESS>    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's Regulations under
the NGA (18 CFR 157.205) file a protest to the request. If no protest
is filed within the time allowed therefore, the proposed activity shall
be deemed to be authorized effective the day after the time allowed for
protest. If a protest is filed and not withdrawn within 30 days after
the time allowed for filing a protest, the instant request shall be
treated as an application for authorization pursuant to section 7 of
the NGA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a) (1) (iii) and the instructions on the Commission's Web
site (www.ferc.gov) under the ``e-Filing'' link. Persons unable to file
electronically should submit an original and 14 copies of the protest
or intervention to the Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426.

    Dated: June 13, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-14733 Filed 6-19-13; 8:45 am]
BILLING CODE 6717-01-P


for pool tests and 5000 IU/ml for original donation.  Note
that this is IU/ml, not copies/ml.  The current guidance
document, the CBER guidance document has yet to be updated.
[Slide]
The CBER HCV panels were formulated from window
period units.  This is negative for anti-HCV, of course,
and is anti-HIV and HBsAg and not detectable for quite a
few other viral agents.  It is HCV genotype 1B.  The entire
HCV sequence is known.  This is in collaboration with Dr.
Steve Feinstone that we determined the entire sequence.  At
that time, five laboratories participated in small-scale
studies, and it was determined to contain 5 times 10 copies
7
per milliliter.
[Slide]
So, current CBER HCV RNA panels is a ten-member
panel and was derived from the HCV stock, diluted with a
defibrinated pool plasma.  We have eight positive, ranging
from 5 to 10 copies per milliliter.  It contains two
5
negatives and each was filled 0.57 ml per vial and stored
at minus 70 degrees Celsius.  At that time it was tested by
nine laboratories and seems to be very much in the target
levels that we wanted to have.
[Slide]
Panel member number one, that contains 1000
copies/ml, participated in the collaborative studies.  John

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
Saldanha just mentioned it.  That particular collaborative
study a total of five international HCV reference reagents
were calibrated against the international standard.  In
that particular collaborative study CBER member number one
was assigned to have 250 IU/ml.
[Slide]
We also have HIV-1 RNA panels in CBER.  Panel A,
subtype B has five members, and this is a window period of
plasma units diluted with the antibody negative
defibrinated pool plasma.  It has four positives, ranging
from 100 to 2.5 times 10 copies/ml, and it has one negative
5
and is 1.1 ml per vial.  Actually, the current WHO standard
for HIV is originating from this window period unit.
[Slide]
We also have panel B that is also subtype B that
has ten members.  This is a cultured patient isolate
diluted again with defibrinated plasma.  It has eight
positive, ranging from 10 to 2.5 times 10 copies/ml.  It
5
does have 105,000 copies in the panels.  There are two
negatives and the fill size is 1.25 ml/vial.
[Slide]
The third panel is HIV subtype panel.  This is
under development.  It has eight subtype panels, A, C, D,
E, F, G, N and O.  Each panel has seven members, except
that N has four and O has 18 members.  Right now, currently

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
it is under pilot-scale studies.  It is being characterized
and titered by several NAT manufacturers.  Full-scale
panels will be formulated if data obtained from pilot-scale
panels are as expected.  I would like to mention that all
these HIV panels are formulated in Dr. Hewlett's
laboratory.
[Slide]
In BPAC, held in September, 1999, they agreed
that -- this is the exact wording that I put in here on the
slide -- pending a policy on screening whole blood
donations, FDA may not require studies to validate the
clinical effectiveness of NAT for B19 DNA under IND for
plasma for further manufacturing.  So, this only applies
for recovered plasma and source plasma, not for whole
blood.  So parvovirus B19 is an in-process control test.
So, it is unlike HIV, HCV and HBV NAT.  However, in that
BPAC it was mentioned that we should quarantine and destroy
in-date when possible.
[Slide]
Parvovirus B19 NAT, we need the validation as an
analytical test, and approve it under relevant product
license.  Now, the proposed limit, which we mentioned in
the FDA NAT workshop in 1999 and also the subsequent
workshop held by the NHLBI, we said that the proposed limit
is 10 genome equivalent of B19 DNA per milliliter in all
4

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
manufacturing pools.  At that time we didn't have an
international standard.  So, we would like to proposed that
as 10 IU of B19 DNA per milliliter in all manufacturing
4
pools.
As you know, this particular level was set
because of the B19 transmission associated with the SV-
treated pooled plasma in the Phase IV study in healthy
donors.  In that particular instance, less than 10 genome
4
equivalent/ml, none of the lots transmitted to the
recipients.  So, for such high titer screening, whatever
the residual B19, it will be neutralized by the anti-B19
present in all large pools, and then also whatever the
residual B19 is will be cleared by the manufacturing
procedure.
[Slide]
So, for standardization of B19 NAT from plasma
for further manufacturing we proposed that, for instance,
in preclinical studies, like for specificity studies, we
proposed to have 500 healthy donors monitored and also
100,000 donations in the form of minipools.  Then for
sensitivity we would like to have about 20 known positives,
and for analytical specificity, like interference or
analytical sensitivity and precision, it will be very
similar to the guidance documents for HIV and HCV.  As you
know, this is high titer screening for B19.  So, the

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
analytical sensitivity had to be greater, much greater than
100 IU/ml.  And, no clinical studies, and we only would
like to make sure that the manufacturing pool will be
within less than 10 IU of the B19 DNA per milliliter so
4
that the viral load in the starting pool would be very low
to begin with.
[Slide]
This is for the B19 DNA standard.  This is
derived from a window period plasma unit that has 10
12
equivalent/ml, and we dilute it.  This is with cryopooled
plasma.  It is not defibrinated plasma.  This one is anti-
B19 negative plasma.  So, the formulated standards contain
10
6
IU/ml.  This is 1 ml per vial.  The consensus titer was
determined by collaborative studies because the CBER
preparation is a liquid formulation targeted to contain 10
6
genome equivalents.  It was a candidate preparation for
establishing an international standard for B19 DNA.  Of
course, AA, which is the freeze-dried preparation, was
selected as an international standard but the CBER standard
was determined to contain 10 IU/ml.
6
[Slide]
So, we questioned the BPAC in June, 2000 should
the FDA recommend that if a plasma pool or minipool is
found to be HAV positive the individual HAV NAT positive

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
donors should be identified and notified of the test
results.
[Slide]
The BPAC decision then was that data provided did
not demonstrate risks significant enough to warrant donor
notification and look-back measures.  So, HAV NAT, by
default, for plasma for further manufacturing is an in-
process test and is not a donor screened test.  That now
needs to be validated by a clinical trial.
[Slide]
We have not yet set any standards for HAV NAT.
However, based on the viral load, the HAV NAT will be very
similar to HIV and HCV NAT validation.
[Slide]
So, we formulated a CBER HAV RNA standard, and
this is derived from a window period plasma unit that
contained 10 copies/ml, and diluted with the cryopooled
6
plasma.  It is estimated to contain 10 copies/ml.  However,
4
the consensus level is still being determined by the WHO
collaborative studies because this was one of the candidate
preparations to establish the WHO standards for HAV NAT.
And, it is 1 ml/vial, stored at minus 70 degrees Celsius.
[Slide]
Let me talk about quality assurance.  As you
know, for quality assurance we have assay validation that

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
includes the laboratory tests and well as clinical testing,
specificity, sensitivity and precision.  Quality assurance
also includes quality control testing of components and
final test kits, and acceptance criteria specification has
to be set to ensure lot-by-lot consistency and also Good
Manufacturing and Good Laboratory Practices.
[Slide]
The quality assurance issues we already talked
about.  We really need to standardize the assay using the
well characterized panels and reference standards.  We need
to ensure the quality control of components and, finally,
test kits using, again, well characterized panels and
reference standards.  Then, we also need to monitor
operator proficiency using proficiency panels and training
programs.
[Slide]
Other quality assurance issues, for instance, the
sample preparation includes collection, storage and
extraction and, actually, improved transportation as well.
The manufacturing consistency of primers, probes and
enzymes is very crucial.  Performance of controls,
calibrators and quantitation standards, specimen and kit
stability, instrument and software validation.
Here I mention some controls and quantitation
standards, like potency of specimen controls, purity,

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
identity and potency of synthetic oligo, internal controls
and quantitative standards.  Then, the stability and you
also need to make sure you have the control set at, you
know, low, medium copy numbers and so forth.  Acceptance
criteria and specifications need to be set.
[Slide]
Finally, in the interest of time, I am just going
to mention the issues for pool specimens, for instance, for
the QA issues.  Demonstrate enhanced sensitivity or
equivalence of testing pool, the current methods, evaluate
the matrix effect due to pooling, and validate logging and
tracking procedures for the inventory of specimens in a
given pool.  You need quality assurance in computing and
recording of results.  We also need to validate
instruments, these different instruments and software used
to monitor pool specimens.
[Slide]
We have a guidance document.  We have an FDA
guidance document for HIV-1 and 2, and this can apply for
HCV and other viruses in general.  Then, we also have
another guidance document, a draft guidance document that
Dr. Mied already mentioned, and there is a guidance
document that is specific for NAT for HCV.  It is a very
good document.  Dr. Micha Nubling already mentioned it.  I
list some of the analytical procedures.  Some are FDA and

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
ICH documents to validate some of the NAT test as an
analytical procedure.  This can be a reference document.
[Slide]
In summary, NAT is currently being implemented in
the U.S. as either donor screening or in-process control.
For standardization, CBER currently has reference panels
for HIV and working reagents for B19 and HAV.  So, we need
quality assurance for NAT-based tests used to screen blood
and plasma donations.  Thank you very much for your
attention.
DR. BISWAS:  Are there any questions for Mei-
ying?  No?  In that case, we will break for lunch.
DR. YU:  Is there general discussion for Dr.
Saldanha, Dr. Nubling and myself?
DR. BISWAS:  They want lunch!
[Whereupon, at 12:05 the proceedings were
recessed to reconvene at 1:05 p.m.]

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
A F T E R N O O N
S E S S I O N
DR. YUWEN:  We are going to start the afternoon
session.  I would like to make a short announcement for
this afternoon's schedule.  This afternoon we are going to
have three sessions.  Session number three is going to be
experience with the minipool NAT for donor screening, and
we have numerous industry presentations.  After section
three, we will have section four, which is progress towards
single unit NAT.  Then there is going to be experience with
minipool NAT screening for HAV/parvovirus B19.  We have a
tight schedule and each presenter is allowed to have no
more than ten minutes.  What I would prefer is for
everybody to present about eight minutes or so and leave a
minute or two for a short discussion.
Once our computer starts, I will first introduce
Dr. Any Conrad, representing NGI.  I have a clock with me.
This will force everybody, and the clock is set for eight
minutes so when the clock clicks you know you have no more
than two minutes left.  Thank you.
III.  Experience with Minipool NAT for Donor
Screening (HIV/HBV/HCV) Plasma for  Further
Manufacturing NGI
DR. CONRAD:  Hold on a moment.  Don't start my
clock yet!  If any fire alarms go off, I get extra time!

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
[Slide]
I am sure many of us have heard this, we are
going to do a summary of the HCV, HIV and HBV trials
conducted with many of my associates, partners and
collaborators who you will hear from in a moment.  I will
briefly give the results of the HCV and HIV trials that
resulted in our approval, and the status of the HBV.  I
thought I would do one other thing.  Since everyone else
who comes after me is going to break down their individual
things, I thought I would group all of the testing that we
have done into one massive group and see how those numbers
compare to the individual companies that you will hear from
later.
[Slide]
At NGI we use a modified PCR method technology
that uses Southern Blot detection.  I am sure many of you
have heard this before.  The HIV and HCV tests are now
approved and HBV is being run under an IND.  We use a
robotic pooling device, called the T-can.  It makes pools
of 512 -- I apologize to all of you who have seen this 2000
times, but we will get this clear one last time.
[Slide]
That is the T-can.
[Slide]

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
The way we make pools is our pools are eight by
eight by eight pools, consisting of 512 members.  So, the
pools have 512.  If you test a pool and the pool is
negative, we make the inference then that all of its
component members are negative.  If it is positive, all
that you need to do is test a row of eight, a column of
eight and a layer of eight and --
[Slide]
--
lo and behold, where the row, layer and column
intersect you have the positive sample.  So, essentially
what it does is -- this is an economy measure; it makes
things faster, easier and less expensive.
[Slide]
The sensitivity assays, as determined in the
analytical sensitivity components of our submissions were,
for the HBV, we use 2 ml which comes out with a 95 percent
detection limit of 4 copies or 1 international unit; for
the HCV-1 ml assay we have a 95 percent detection cut-off
of 20 copies with 5 international units; and the HIV is 1.4
and 5.
Listening to Mike Busch's talk this morning, I
was struck by an interesting point and I will diverge for a
minute from my talk, and that is that when we talk about
single unit testing, the other alternative to that would be
to drive the sensitivity of assays lower and lower and

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
lower.  Theoretically, by increasing the amount of material
that we test we can actually get the detection cut-offs to
be sub single unit.  We can make them 0.3 IU/ml.  That may,
in fact, turn out to be a more economic mechanism than
going to single unit donations.  I think you can achieve
the same sensitivity.  If we were to take all 512 members
of the pool and test the entire pool instead of an aliquot
of the pool, theoretically it would be the equivalent of
single unit testing, but that would necessitate us getting
better and better mechanisms to purify viruses from high
volumes.
[Slide]
The clinical trials were conducted on 343,729
donations from approximately 48,000 randomly selected
donors.  The samples were also tested for the standard
immunologic tests, but an important distinction needs to be
made here, that samples from new donors were tested by RT-
PCR only after they had passed their serologic testing, but
all donors that were already in the system or not new to
the system were tested simultaneously with the RT-PCR
reaction.  So, there will be numbers that I give you that
have people who were both serologically positive as well as
serologically negative.
[Slide]

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
The results for the HCV were 0.031 percent of the
donations, or 105 out of the 342,000 that were found to be
positive for HCV, and 85 of these donations were EIA
negative.  In other words, they were in the window period.
But since other serologic tests also occur, like ALT, we
took those 85 samples and we looked at how many of them had
normal ALTs.  So, 75 of those units would not have been
interdicted had NAT testing not been employed.
[Slide]
Just some interesting numbers to keep in mind.
The mean time to seroconversion for the samples we detected
in the study was 57 days, plus/minus 14.  The range went
from 22 to 120 days.  The average viral load of these
antibody-negative ALT normal samples was 1.36 times 10
7
copies, so very high titer.  Obviously, that supports all
the data that showed this rapid and high increase in viral
load, with a low of 7500 and a high of 56 million
copies/ml.
@342[Slide]
The HIV results show that 18 out of the 342,000
donations were found positive for HIV.  Ten were both
antibody and antigen negative; eight were positive for
either p24 or antibody by the time we encountered them in
the pooling system.  Of the 18 donations, they came from

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
four donors, for a frequency of approximately 1/12,000
donors.
[Slide]
An important component, which is going to be
discussed I think in further detail later, is that we made
supplemental comparisons of the HIV pool testing using NAT
compared to both Colter and Abbott's p24 antigen kit.  I
think, again, the most important message and summary
message here is to notice that the antigen positive, PCR
negative samples -- there were none, and this led to our
ability to submit in the license the statement that PCR is
a substitute for the p24 antigen test, much to the delight
of some and chagrin of others.
[Slide]
The conclusions are that 75 of the donations for
HCV wouldn't have been intervened.  A total of 8.5 times
10
11
copies were interdicted and not placed into plasma
because of NAT testing, and the HCV plasma testing was
actually sort of simple and functional to do.
[Slide]
For HIV, six HIV units were interdicted that
would not have been detected, for a total viral load of
about 7.15 times 10 and, again, an important thing is that
8
the safety of the units was actually enhanced by using PCR
and antibody screening versus p24 and antibody screening.

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
[Slide]
HBV, just briefly a summary because you are going
to see a lot of detail about this, we have actually
identified two different classes of individuals.  We found
people who were heading towards an acute stage of HBV,
where they have a rapid escalation in viremia, followed by
S-antigen positive, and those people then get brought out
and those are the acutes.  We have also found a second and
more common class of people whom we call the chronics, who
have these sort of low, smoldering viral loads.  They are
also sometimes S-antigen positive but we have also found a
group in here who have S-antibody, core antibody.  So, they
are S-antigen negative but they still have some DNA.  So,
HBV adds a more complicated series of issues that have to
be addressed, and I think that you will hear more about
that in a bit from my colleagues.
[Slide]
But there are four classes of people that you can
encounter, the HBV core antibody negative, positive and
different antigen statuses.  I think that that is going to
be important.


[Federal Register: August 3, 2009 (Volume 74, Number 147)]
[Notices]
[Page 38451-38456]
[DOCID:fr03au09-81]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0339]

Prescription Drug User Fee Rates for Fiscal Year 2010

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) 2010. The Federal
Food, Drug, and Cosmetic Act (the act), as amended by the Prescription
Drug User Fee Amendments of 2007 (Title 1 of the Food and Drug
Administration Amendments Act of 2007 (FDAAA)) (PDUFA IV), authorizes
FDA to collect user fees for certain applications for approval of drug
and biological products, on establishments where the products are made,
and on such products. Base revenue amounts to be generated from PDUFA
fees were established by PDUFA IV, with provisions for certain
adjustments. Fee revenue amounts for applications, establishments, and
products are to be established each year by FDA so that one-third of
the PDUFA fee revenues FDA collects each year will be generated from
each of these categories. This notice establishes fee rates for FY 2010
for application fees for an application requiring clinical data
($1,405,500), for an application not requiring clinical data or a
supplement requiring clinical data ($702,750), for establishment fees
($457,200), and for product fees ($77,720). These fees are effective on
October 1, 2009, and will remain in effect through September 30, 2010.
For applications and supplements that are submitted on or after October
1, 2009, the new fee schedule must be used. Invoices for establishment
and product fees for FY 2010 will be issued in August 2009, using the
new fee schedule.

FOR FURTHER INFORMATION CONTACT:  David Miller, Office of Financial
Management (HFA-100), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 735 and 736 of the 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 approval of drug and biological products, (2) certain
establishments where such products are made, and (3) certain products
(section 736(a) of the act). When certain conditions are met, FDA may
waive or reduce fees (section 736(d) of the act).
    For FY 2008 through FY 2012, the base revenue amounts for the total
revenues from all PDUFA fees are established by PDUFA IV. The base
revenue amount for FY 2008 is to be adjusted for workload, and that
adjusted amount becomes the base amount for the remaining 4 fiscal
years. That adjusted base revenue amount is increased for drug safety
enhancements by $10,000,000 in each of the subsequent 4 fiscal years,
and the increased total is further adjusted each year for inflation and
workload. 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 notice uses the fee base revenue amount for FY 2008 published
in the Federal Register of October 12, 2007 (72 FR 58103), adjusts it
for the 2010 drug safety increase (see section 736(b)(4) of the act)
for inflation, and for workload, and then establishes the application,
establishment, and product fees for FY 2010. These fees are effective
on October 1, 2009, and will remain in effect through September 30,
2010.

II. Fee Revenue Amount for FY 2010

    The total fee revenue amount for FY 2010 is $569,207,000, based on
the fee revenue amount specified in the statute, including additional
fee funding for drug safety and adjustments for inflation and changes
in workload. The statutory amount and a one-time base adjustment are
described in sections II.A and II.B of this document. The adjustment
for inflation is described in section II.C of this document, and the
adjustment for changes in workload in section II.D of this document.

A. FY 2010 Statutory Fee Revenue Amounts Before Adjustments

    PDUFA IV specifies that the fee revenue amount before adjustments
for FY 2010 for all fees is $437,783,000 ($392,783,000 specified in
section 736(b)(1) of the act plus an additional $45,000,000 for drug
safety in FY 2010 specified in section 736(b)(4) of the act).

B. Base Adjustment to Statutory Fee Revenue Amount

    The statute also specifies that $354,893,000 of the base amount is
to be further adjusted for workload increases through FY 2007 (see
section 736(b)(1)(B) of the act). The adjustment on this amount is to
be made in accordance with the workload adjustment provisions that were
in effect for FY 2007, except that the adjustment for investigational
new drug (IND) workload is based on the number of INDs with a
submission in the previous 12 months rather than on the number of new
commercial INDs submitted in the same 12-month period.
    For each FY beginning in FY 2004, the Prescription Drug User Fee
Amendments of 2002 (PDUFA III) provided that fee revenue amounts, after
they had been adjusted for inflation, should be further adjusted to
reflect changes in workload for the process for the review of human
drug applications (see section 736(c)(2) of the act). The conference
report accompanying PDUFA III, House of Representatives Report number
107-481, provides guidance on how the workload adjustment provision of
PDUFA III is to be implemented. Following that guidance, FDA calculated
the average number of each of the four types of submissions specified
in the workload adjustment provision (human drug applications,
commercial INDs, efficacy supplements, and manufacturing supplements)
received over the 5-year period that ended on June 30, 2002 (base
years), and the average number of each of these types of applications
over the most recent 5-year period that ended June 30, 2007. PDUFA IV
directs that this same method be used in making the workload adjustment
apply to the 2008 statutory revenue amount, except that for this
calculation the number of commercial INDs with a submission in the
previous 12 months is used for each 12-month period rather than the
number of new commercial INDs submitted (see section 736(b) of the act,
as amended by PDUFA IV).
    The results of these calculations are presented in the first two
columns of table 1 of this document. Column 3 reflects the percent
change in workload over the two 5-year periods. 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 5 years. Column 5 of
table 1 of this document 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. At the bottom right of the table the sum of the
values in column 5 is added, reflecting a total increase in workload of
11.73 percent when compared to the base years.

            Table 1.--Summary Workload Adjuster Calculation to be Applied to PDUFA IV Statutory Base
----------------------------------------------------------------------------------------------------------------
                Column 1  5-Year
 Application   Average Base Years   Column 2  5-Year   Column 3  Percent       Column 4       Column 5  Weighted
     Type            (Ending         Average (Ending         Change        Weighting Factor     Percent Change
               6[sol]30[sol]2002)  6[sol]30[sol]2007)
----------------------------------------------------------------------------------------------------------------
NDAs/                       119.6               123.8              3.5%              35.2%                1.24%
 biologics
 license
 applications
 (BLAs)
----------------------------------------------------------------------------------------------------------------
Active INDs               4,751.8             5,528.2             16.3%              44.2%                7.22%
----------------------------------------------------------------------------------------------------------------
Efficacy                    159.2               163.4              2.6%               7.4%                0.20%
 supplements
----------------------------------------------------------------------------------------------------------------
Manufacturing             2,100.6             2,589.2             23.3%              13.2%                3.07%
 supplements
----------------------------------------------------------------------------------------------------------------
Workload adjuster to be applied to the statutory base                                                    11.73%
----------------------------------------------------------------------------------------------------------------

    Increasing the PDUFA IV statutorily specified amount of
$354,893,000 by the specified workload adjuster (11.73 percent) results
in an increase of $41,629,000, rounded to the nearest thousand. Adding
this amount to the $437,783,000 statutorily specified amount from
section II.A of this document, results in a total adjusted PDUFA IV
base revenue amount of $479,412,000, before further adjustment for
inflation and changes in workload after FY 2007.

C. Inflation Adjustment to FY 2010 Fee Revenue Amount

    PDUFA IV provides that fee revenue amounts for each fiscal year
after FY 2008 shall be adjusted for inflation. The adjustment must
reflect the greater of the following amounts: (1) The total percentage
change that occurred in the Consumer Price Index (CPI) (all items; U.S.
city average) during the 12-month period ending June 30 preceding the
fiscal year for which fees are being set; (2) the total percentage pay
change for the previous fiscal year for Federal employees stationed in
the Washington, DC metropolitan area; or (3) the average annual change
in cost, per full time equivalent (FTE) FDA position, of all personnel
compensation and benefits paid for the first 5 of the previous 6 fiscal
years. PDUFA IV provides for this annual adjustment to be cumulative
and compounded annually after FY 2008 (see section 736(c)(1) of the
act).
    The first factor is the CPI increase for the 12-month period ending
in June 2009. The CPI for June 2009 was 215.693, and the CPI for June
2008 was 218.815. (These CPI figures are available on the Bureau of
Labor Statistics Web site at http://data.bls.gov/cgi-bin/surveymost?bls
by checking the first box under ``Price Indexes'' and then clicking
``Retrieve Data'' at the bottom of the page.) (FDA has verified the Web
site address, but FDA is not responsible for any subsequent changes to
the Web site after this document publishes in the Federal Register.)
The CPI for June 2009 is 1.43 percent lower than the CPI for the
previous 12-month period.
    The second factor is the increase in pay for the previous fiscal
year (FY 2009 in this case) for Federal employees stationed in the
Washington, DC metropolitan area. This figure is published by the
Office of Personnel Management, and found on their Web site at http://
www.opm.gov/flsa/oca/09tables/html/dcb.asp above the salary table. (FDA
has verified the Web site address, but FDA is not responsible for any
subsequent changes to the Web site after this document publishes in the
Federal Register.) For FY 2009 it was 4.78 percent.
    The third factor is the average change in FDA cost for compensation
and benefits per FTE over the previous 5 of the most recent 6 fiscal
years (FY 2003 through 2008). The data on total compensation paid and
numbers of FTE paid, from which the average cost per FTE can be
derived, are published in FDA's Justification of Estimates for
Appropriations Committees. Table 2 of this document summarizes that
actual cost and FTE use data for the specified fiscal years, and
provides the percent change from the previous fiscal year and the
average percent change over the most 5 recent fiscal years, which is
5.54 percent.

              Table 2.--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
                                                                                Annual Average
   Fiscal Year         2004            2005            2006            2007            2008        Increase for
                                                                                Latest 5 Years
----------------------------------------------------------------------------------------------------------------
Total PC&B            $1,042,749      $1,077,604      $1,114,704      $1,144,369      $1,215,627  ..............
----------------------------------------------------------------------------------------------------------------
Total FTE                 10,141           9,910           9,698           9,569           9,811  ..............
----------------------------------------------------------------------------------------------------------------
PC&B per FTE            $102,825        $108,739        $114,942        $119,591        $123,905  ..............
----------------------------------------------------------------------------------------------------------------
% Change from              8.59%           5.75%           5.70%           4.05%           3.61%           5.54%
 previous year
----------------------------------------------------------------------------------------------------------------

    The inflation increase for FY 2010 is 5.54 percent. This is the
greater of the CPI change during the 12-month period ending June 30
preceding the fiscal year for which fees are being set (-1.43 percent),
the increase in pay for the previous fiscal year (FY 2009 in this case)
for Federal employees stationed in the Washington, DC metropolitan area
(4.78 percent), and the average annual change in cost, per FTE FDA
position, of all personnel compensation and benefits paid for the first
5 of the previous 6 fiscal years (5.54 percent). Because the average
change in pay per FTE (5.54 percent) is the highest of the three
factors, it becomes the inflation

adjustment for total fee revenue for FY 2010.
    The inflation adjustment for FY 2009 was 5.64 percent. This is the
greater of the CPI increase during the 12-month period ending June 30
preceding the fiscal year for which fees were being set (June 30, 2008,
which was 5.05 percent), the increase in pay for FY 2008 for Federal
employees stationed in Washington, DC (4.49 percent), or the average
annual change in cost, per FTE FDA position, of all personnel
compensation and benefits paid for the first 5 of the previous 6 fiscal
years (5.64 percent).
    PDUFA IV provides for this inflation adjustment to be cumulative
and compounded annually after FY 2008 (see section 736(c)(1) of the
act). This factor for FY 2010 (5.54 percent) is compounded by adding
one to it and then multiplying it by one plus the inflation adjustment
factor for FY 2009 (5.64 percent). The result of this multiplication of
the inflation factors for the 2 years since FY 2008 (1.0554 times
1.0564 percent) becomes the inflation adjustment for FY 2010. This
inflation adjustment for FY 2010 is 11.15 percent.
    Increasing the FY 2010 fee revenue base of $479,412,000, by 11.15
percent yields an inflation-adjusted fee revenue amount for FY 2010 of
$532,866,000, rounded to the nearest thousand dollars, before the
application of the FY 2010 workload adjustment.

D. Workload Adjustment to the FY 2010 Inflation Adjusted Fee Revenue
Amount

    PDUFA IV does not allow FDA to adjust the total revenue amount for
workload beginning in FY 2010 unless the independent accounting firm
study is complete (see section 736(c)(2)(C) of the act). That study,
conducted by Deloitte Touche, LLP, was completed on March 31, 2009, and
is available online at http://www.fda.gov/ForIndustry/UserFees/
PrescriptionDrugUserFee/ucm164339.htm. The study found that the
adjustment methodology used by FDA reasonably captures changes in
workload for reviewing human drug applications under PDUFA IV.
Accordingly, FDA continues to use the workload adjustment methodology
that it utilized in FY 2009, and FDA intends to continue using this
methodology through the end of PDUFA IV.
    For each fiscal year beginning in FY 2009, PDUFA IV provides that
fee revenue amounts, after they have been adjusted for inflation, shall
be further adjusted to reflect changes in workload for the process for
the review of human drug applications (see section 736(c)(2) of the
act). PDUFA IV continues the PDUFA III workload adjustment with
modifications, and provides for a new additional adjustment for changes
in review activity.
    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 INDs (applications that have
at least one submission during the previous 12 months), (3) efficacy
supplements, and (4) manufacturing supplements received over the 5-year
period that ended on June 30, 2007 (base years), and the average number
of each of these types of applications over the most recent 5-year
period that ended June 30, 2009.
    The calculations are summarized in of table 3 of this document. The
5-year averages for each application category are provided in Column 1
(``5-Year Average Base Years 2002-2007'') and Column 2a (``5 Year
Average 2004-2009'').
    PDUFA IV specifies that FDA make additional adjustments for changes
in review activities to the first two categories (human drug
applications and active commercial INDs). These adjustments, specified
under PDUFA IV, are summarized in columns 2b and 2c in table 3 of this
document. The number in the NDAs/BLAs line of column 2b of table 3 of
this document is the percent by which the average workload for
meetings, annual reports, and labeling supplements for NDAs and BLAs
has changed from the 5-year period 2002 through 2007 to the 5-year
period 2004 through 2009. Likewise, the number in the ``Active
commercial INDs'' line of column 2b of table 3 of this document is the
percent by which the workload for meetings and special protocol
assessments for active commercial INDs has changed from the 5-year
period 2002 through 2007 to the 5-year period 2004 through 2009. There
is no entry in the last two lines of column 2b because the adjustment
for changes in review workload does not apply to the workload for
efficacy supplements and manufacturing supplements.
    Column 3 of table 3 of this document reflects the percent change in
workload from column 1 to column 2c. 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 5 years. Column 5 of table 3 of
this document 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.
At the bottom right of table 3 of this document is the sum of the
values in column 5 that are added, reflecting an increase in workload
of 6.82 percent for FY 2010 when compared to the base years.

                                                   Table 3.--Workload Adjuster Calculation for FY 2010
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Column 2b                      Column 3
                                                  Column 1  5-  Column 2a  5-    Adjustment    Column 2c is     Percent        Column 4       Column 5
                Application Type                  Year Average   Year Average   for Changes     Column 2a        Change       Weighting       Weighted
                                                   Base Years     2004-2009      in Review     Increased by   (Column 1 to      Factor        Percent
                                                   2002-2007                      Activity      Column 2b      Column 2c)                      Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDAs/BLAs                                                123.8          133.0        -0.73%           132.0          6.6%          34.8%          2.31%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Active commercial INDs\1\                              5,528.2        6,078.0        -0.71%         6,035.0          9.2%          44.5%          4.08%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy supplements                                     163.4          169.4        NA               169.4          3.7%           8.7%          0.32%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturing supplements                              2,589.2        2,613.6        NA             2,613.6          0.9%          12.0%          0.11%
--------------------------------------------------------------------------------------------------------------------------------------------------------

FY 2010 workload adjuster                                                                                6.82%
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Table 3 published in the Federal Register of August 1, 2008 (73 FR 45017), showed the average number of active INDs for the base years of 2002-2007
  as 5,755.8. FDA discovered that a small subset of INDs had been double counted in the number reported last year. That error has been corrected in the
  revised number of 5528.2 reflected in the table this year. Had the error not been made, the workload adjustment in FY 2009 would have been 3.76
  percent rather than the 2.98 percent published in the Federal Register last year.

    The 2010 workload adjuster reflected in the calculations in table 3
of this document is 6.82 percent. Therefore the inflation-adjusted
revenue amount of $532,866,000 from section II.C of this document will
be increased by the 2010 workload adjuster of 6.82 percent, resulting
in a total adjusted revenue amount in FY 2010 of $569,207,000, rounded
to the nearest thousand dollars.

E. Rent and Rent-Related Adjustment to the FY 2010 Adjusted Fee Revenue
Amount

    PDUFA specifies that for FY 2010 and each subsequent fiscal year,
the revenue amount will be decreased if the actual cost paid for rent
and rent-related expenses for preceding fiscal years are less than
estimates made for such fiscal years in FY 2006 (see section 736(c)(3)
of the act). The only fiscal year which has been completed, and for
which FDA has complete data at this time, is FY 2008. Table 4 of this
document shows the estimates of rent and rent-related costs for FY 2008
made in 2006 and the actual costs at the end of the fiscal year.

             Table 4.--Comparison of Actual and Estimated Rent and Rent-Related Expenses for FY 2008
----------------------------------------------------------------------------------------------------------------
                                                Estimates Made in 2006           Actual FY 2008 Year-End Costs
----------------------------------------------------------------------------------------------------------------
Center for Drug Evaluation and Research                          $46,732,000                         $51,619,000
 rent & rent-related expenses
----------------------------------------------------------------------------------------------------------------
Center for Biologics Evaluation and                              $22,295,000                         $26,715,000
 Research rent & rent-related expenses
----------------------------------------------------------------------------------------------------------------
TOTAL                                                            $69,027,000                         $78,334,000
----------------------------------------------------------------------------------------------------------------

    Because FY 2008 costs for rent and rent-related items exceeded the
estimates of these costs made in 2006, no decrease in the FY 2010
estimated PDUFA revenues is required under this provision of PDUFA.
    PDUFA 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 act).
Accordingly, one-third of the total revenue amount ($569,207,000),
i.e., $189,736,000 (rounded to the nearest thousand dollars), is the
total amount of fee revenue that will be derived from each of these fee
categories.

III. 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 $189,736,000, rounded to the nearest thousand
dollars, in FY 2010, as calculated previously in this document.

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

    For FY 2008 through FY 2012, FDA will estimate the total number of
fee-paying full application equivalents (FAEs) it expects to receive
the next fiscal year by averaging the number of fee-paying FAEs
received in the 5 most recent fiscal years. This use of the rolling
average of the 5 most recent fiscal years is the same method that has
applied for the last 6 years.
    In estimating the number of fee-paying FAEs that FDA will receive
in FY 2010, the 5-year rolling average for the most recent 5 years will
be based on actual counts of fee-paying FAEs received for FY 2005
through FY 2009. For FY 2009, FDA is estimating the number of fee-
paying FAEs for the full year based on the actual count for the first 9
months and estimating the number for the final 3 months, as we have
done for the past 7 years.
    Table 5 of this document shows, in column 1, the total number of
each type of FAE received in the first 9 months of FY 2009, whether
fees were paid or not. Column 2 shows the number of FAEs for which fees
were waived or exempted during this period, and column 3 shows the
number of fee-paying FAEs received through June 30, 2009. Column 4
estimates the 12-month total fee-paying FAEs for FY 2009 based on the
applications received through June 30, 2009. All of the counts are in
FAEs. A full application requiring clinical data counts as one FAE. An
application not requiring clinical data counts as one-half 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.

 Table 5.--FY 2009 Full Application Equivalents Received Through June 30, 2009, and Projected Through September
                                                    30, 2009
----------------------------------------------------------------------------------------------------------------
                                                           Column 2  Fee     Column 3  Total
                                       Column 1  Total    Exempt or Waived      Fee Paying       Column 4  12-
        Application or Action          Received Through       Through            Through        Month Fee-Paying
                                      6[sol]30[sol]2009  6[sol]30[sol]2009  6[sol]30[sol]2009      Projection
----------------------------------------------------------------------------------------------------------------
Applications requiring clinical data             88.75               32.75             56                  74.7
----------------------------------------------------------------------------------------------------------------
Applications not requiring clinical              15.5                 4.5              11                  14.7
 data
----------------------------------------------------------------------------------------------------------------
Supplements requiring clinical data              47.5                 8.5              39                  52
----------------------------------------------------------------------------------------------------------------
Withdrawn or refused to file                      0.625               0                 0.625               0.8
----------------------------------------------------------------------------------------------------------------
Total                                           153.375              45.75            106.25              142.2
----------------------------------------------------------------------------------------------------------------

    In the first 9 months of FY 2009, FDA received 153.375 FAEs, of
which 106.25 were fee-paying. Based on data from the last 10 fiscal
years, on average, 25 percent of the applications submitted each year
come in the final 3 months. Dividing 106.25 by 3 and multiplying by 4
extrapolates the amount to the full 12 months of the fiscal year and
projects the number of fee-paying FAEs in FY 2008 at 142.2.
    As table 6 of this document shows, the average number of fee-paying
FAEs received annually in the most recent 5-year period, and including
our estimate for FY 2009, is 135.0 FAEs. FDA will set fees for FY 2010
based on this estimate as the number of full application equivalents
that will pay fees.

                                                         Table 6.--Fee-Paying FAE 5-Year Average
--------------------------------------------------------------------------------------------------------------------------------------------------------
              Fiscal Year                      2005               2006               2007               2008               2009          5-Year Average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs                                     121.5              136.7              134.4              140.0              142.2              135.0
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The FY 2010 application fee is estimated by dividing the average
number of full applications that paid fees over the latest 5 years,
135.0, into the fee revenue amount to be derived from application fees
in FY 2010, $189,736,000. The result, rounded to the nearest $100, is a
fee of $1,405,500 per full application requiring clinical data, and
$702,750 per application not requiring clinical data or per supplement
requiring clinical data.

IV. Fee Calculations for Establishment and Product Fees

A. Establishment Fees

    At the beginning of FY 2009, the establishment fee was based on an
estimate that 400 establishments would be subject to, and would pay,
fees. By the end of FY 2009, FDA estimates that 450 establishments will
have been billed for establishment fees, before all decisions on
requests for waivers or reductions are made. FDA again estimates that a
total of 20 establishment fee waivers or reductions will be made for FY
2009. In addition, FDA estimates that another 15 full establishment
fees will be exempted this year based on the orphan drug exemption in
FDAAA (see section 736(k) of the act). Subtracting 35 establishments
(20 waivers plus the estimated 15 establishments under the orphan
exemption) from 450 leaves a net of 415 fee-paying establishments. FDA
will use 415 for its FY 2010 estimate of establishments paying fees,
after taking waivers and reductions into account. The fee per
establishment is determined by dividing the adjusted total fee revenue
to be derived from establishments ($189,736,000) by the estimated 415
establishments, for an establishment fee rate for FY 2010 of $457,200
(rounded to the nearest $100).

B. Product Fees

    At the beginning of FY 2009, the product fee was based on an
estimate that 2,380 products would be subject to and would pay product
fees. By the end of FY 2009, FDA estimates that 2,450 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 about 50 waivers and reductions granted. In addition, FDA
estimates that another 20 product fees will be exempted this year based
on the orphan drug exemption in FDAAA (see section 736(k) of the act).
FDA estimates that 2,380 products will qualify for product fees in FY
2009, after allowing for waivers and reductions, including the orphan
drug products eligible under the FDAAA exemption, and will use this
number for its FY 2010 estimate. Accordingly, the FY 2010 product fee
rate is determined by dividing the adjusted total fee revenue to be
derived from product fees ($189,736,000) by the estimated 2,380
products for a FY 2010 product fee of $79,720 (rounded to the nearest
$10).

V. Fee Schedule for FY 2010

    The fee rates for FY 2010 are set out in table 7 of this document:

                                Table 7.
------------------------------------------------------------------------
                                                           Fee Rates for
                      Fee Category                            FY 2010
------------------------------------------------------------------------
APPLICATIONS............................................................
  Requiring clinical data...............................      $1,405,500
  Not requiring clinical data...........................        $702,750
  Supplements requiring clinical data...................        $702,750
ESTABLISHMENTS..........................................        $457,200
PRODUCTS................................................         $79,720
------------------------------------------------------------------------

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 after September 30, 2009. Payment must be made
in U.S. currency by check, bank draft, or U.S. postal money order
payable to the order of the Food and Drug Administration. 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 70963, Charlotte, NC 28272-
0963.
    If checks are to be sent by a courier that requests a street
address, the courier can deliver the checks to: Wachovia Bank, Attn:
Food and Drug Administration Lockbox 70963, 1525 West WT Harris Blvd.,
rm. NC0810, Charlotte, NC 28262. (Note: This Wachovia Bank address is
for courier delivery only.)
    Please make sure that the FDA post office box number (P.O. Box
70963) is written on the check, bank draft, or postal money order.
    Wire transfer payment may also be used. Please reference your
unique user fee ID number when completing your transfer. The
originating financial institution usually charges a wire transfer fee
between $15.00 and $35.00. Please ask your financial institution about
the fee and include it with your payment to ensure that your fee is
fully paid. The account information is as follows: New York Federal
Reserve Bank, US Dept of Treasury, TREAS NYC, 33 Liberty St., New York,
NY 10045, Acct. No.: 75060099, Routing No.: 021030004, SWIFT: FRNYUS33,
Beneficiary: FDA, 5600 Fishers Lane, Rockville, MD 20857.
    Application fees can also be paid online with an electronic check
(ACH). FDA has partnered with the U.S. Department of the Treasury to
utilize 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.
    The tax identification number of the Food and Drug Administration
is 53-0196965.

B. Establishment and Product Fees

    FDA will issue invoices for establishment and product fees for FY
2010 under the new fee schedule in August 2009. Payment will be due on
October 1, 2009. FDA will issue invoices in November 2010 for any
products and establishments subject to fees for FY 2010 that qualify
for fees after the August 2009 billing.

    Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-18457 Filed 7-31-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 81, Number 37 (Thursday, February 25, 2016)]
[Proposed Rules]
[Page 9367]
[FR Doc No: 2016-03693]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0254; Directorate Identifier 2010-NM-180-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Proposed rule; withdrawal.

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

SUMMARY: The FAA withdraws a notice of proposed rulemaking (NPRM) that
proposed a new airworthiness directive (AD), which would have applied
to certain The Boeing Company Model 737-600, -700, -700C, -800, -900,
and -900ER series airplanes. For certain airplanes, the NPRM would have
required a one-time inspection for damage of the hydraulic actuator rod
ends and actuator attach fittings on the thrust reversers, and repair
or replacement if necessary. For all airplanes, the NPRM would have
required repetitive inspections for damage of the hydraulic actuator
rod ends, attach bolts, and nuts; repetitive inspections for damage of
fitting assemblies, wear spacers, and actuator attach fittings on the
thrust reverser; repetitive measurements of the wear spacer; and
corrective actions if necessary. Since the NPRM was issued, the
manufacturer notified us that an assumption regarding a failure mode of
the rod ends or attachment fittings for the thrust reverser actuator
used in the original safety assessment was incorrect. A new safety
analysis was conducted and we determined that this issue is no longer a
safety concern. Accordingly, the NPRM is withdrawn.

DATES: As of February 25, 2016, the proposed rule, which was published
in the Federal Register on March 22, 2011 (76 FR 15864), is withdrawn.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2011-
0254; 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 action, the NPRM (76 FR 15864, March 22, 2011), the
regulatory evaluation, any comments received, and other information.
The address for the Docket Office (telephone<PHONE_NUMBER>) is the
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: Tak Kobayashi, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification
Office, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-
6499; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We proposed to amend part 39 of the Federal Aviation Regulations
(14 CFR part 39) with a notice of proposed rulemaking (NPRM) for a new
AD for certain The Boeing Company Model 737-600, -700, -700C, -800, -
900, and -900ER series airplanes. The NPRM published in the Federal
Register on March 22, 2011 (76 FR 15864) (``the NPRM''). For certain
airplanes, the NPRM would have required a one-time inspection for
damage of the hydraulic actuator rod ends and actuator attach fittings
on the thrust reversers, and repair or replacement if necessary. For
all airplanes, the NPRM would have required repetitive inspections for
damage of the hydraulic actuator rod ends, attach bolts, and nuts;
repetitive inspections for damage of fitting assemblies, wear spacers,
and actuator attach fittings on the thrust reverser; repetitive
measurements of the wear spacer; and corrective actions if necessary.
    The NPRM was prompted by reports of in-service damage of the
attachment fittings for the thrust reverser actuator. The proposed
actions were intended to detect and correct such damage, which could
result in actuator attach fitting failure, loss of the thrust reverser
auto restow function, and consequent loss of control of the airplane.

Actions Since NPRM Was Issued

    Since we issued the NPRM, the manufacturer has notified us that an
assumption regarding a failure mode of the attachment fittings for the
thrust reverser actuator used in the original safety assessment was
incorrect. It was originally assumed that all hydraulic actuators
attached to the thrust reverser have the failure mode (failure of the
hydraulic actuator rod end or attach fitting due to severe wear-out)
addressed in the NPRM. Based on field reports and design review, the
manufacturer found that certain hydraulic actuators do not have this
failure mode. Based on this new manufacturer finding, a new safety
analysis was conducted and we determined that this issue is no longer a
safety concern.

FAA's Conclusions

    Upon further consideration, we have determined that the safety
concern identified in the NPRM does not affect The Boeing Company Model
737-600, -700, -700C, -800, -900, and -900ER series airplanes
identified in the NPRM. Accordingly, the NPRM is withdrawn.
    Withdrawal of the NPRM does not preclude the FAA from issuing
another related action or commit the FAA to any course of action in the
future.

Regulatory Impact

    Since this action only withdraws an NPRM, it is neither a proposed
nor a final rule and therefore is not covered under Executive Order
12866, the Regulatory Flexibility Act, or DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979).

List of Subjects in 14 CFR Part 39

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

The Withdrawal

    Accordingly, we withdraw the NPRM, Docket No. FAA-2011-0254,
Directorate Identifier 2010-NM-180-AD, which was published in the
Federal Register on March 22, 2011 (76 FR 15864).

    Issued in Renton, Washington, on February 15, 2016.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-03693 Filed 2-24-16; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 75 (Friday, April 17, 2020)]
[Notices]
[Pages 21506-21507]
[FR Doc No: 2020-08149]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2017-0028, Notice 2]

Decision That Nonconforming Model Year 2014 Ferrari LaFerrari
Passenger Cars Are Eligible for Importation

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Grant of petition.

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

SUMMARY: This document announces a decision by the National Highway
Traffic Safety Administration that certain Model Year (MY) 2014 Ferrari
LaFerrari passenger cars (PCs) that were not originally manufactured to
comply with all applicable Federal Motor Vehicle Safety Standards
(FMVSS) are eligible for importation into the United States because the
2014 model year vehicles are substantially similar to vehicles that
were originally manufactured for importation into and offered for sale
in the United States and certified to all applicable FMVSS (the U.S-
certified version of the 2014 Ferrari LaFerrari PCs) or are capable of
being altered to comply with all applicable FMVSS.

DATES: This decision became effective on December 10, 2019.

FOR FURTHER INFORMATION CONTACT: Robert Mazurowski, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. Sec.  30141(a)(l)(A), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS shall be
refused admission into the United States unless NHTSA has decided that
the motor vehicle is substantially similar to a motor vehicle
originally manufactured for importation into and sale in the United
States, certified under 49 U.S.C. Sec.  30115, and of the same model
year as the model of the motor vehicle to be compared, and is capable
of being readily altered to conform to all applicable FMVSS.
    Under 49 U.S.C. 30141(a)(l)(B), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS shall be
refused admission into the United States unless NHTSA has decided its
safety features comply with, or are capable of being altered to comply
with, all applicable FMVSS based on destructive test data or such other
evidence that NHTSA decides to be adequate.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register of each petition that it receives, and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the
petition and any comments that it has received, whether the vehicle is
eligible for importation. The agency then publishes this decision in
the Federal Register.
    J.K. Technologies, LLC, (Registered Importer R-90-006), of
Baltimore, Maryland, petitioned NHTSA to decide whether MY 2014 Ferrari
LaFerrari PCs are eligible for importation into the United States.
NHTSA published a notice of the petition on October 10, 2019 (84 FR
54727) to afford an opportunity for public comment. The reader is
referred to the notice for a thorough description of the petition.

Comments

    Two comments were submitted to this docket The first comment stated
``Luxury cars should not be afforded any other exceptions or privileges
that non-luxury cars are''. This statement is considered non-
substantive as all vehicles are held to the same safety standards
regardless of value. The second comment is a detailed analysis in
support of granting the petition and echoing the petitioners
reasonings.

NHTSA Conclusions

    In its petition, J.K. Technologies noted that the original
manufacturer, Ferrari, certified the MY 2014 Ferrari LaFerrari PCs to
all applicable FMVSS and offered those vehicles for sale in the United
States.
    NHTSA has reviewed the petition and has concluded that the
nonconforming versions of the MY 2014 Ferrari LaFerrari PCs described
in the petition are substantially similar to the U.S.-certified
versions of the MY 2014 Ferrari LaFerrari PCs and are capable of being
readily altered to comply with all applicable FMVSS.

    NHTSA has also determined that any RI who imports or modifies one
of these vehicles must include in the statement of conformity and
associated documents (referred to as a ``conformity package'') it
submits to NHTSA under 49 CFR 592.6(d) additional specific proof to
confirm that the vehicle was manufactured to conform to, or was
successfully altered to conform to, FMVSS No. 138, Tire Pressure
Monitoring Systems, and FMVSS No. 208, Occupant Protection. This proof
must include detailed descriptions of all modifications made to achieve
conformity with those standards, including a detailed description of
systems in place (if any) on the vehicle at the time it was delivered
to the RI and a similarly detailed description of the systems in place
after the vehicle is altered, including photographs of all required
labeling. The description must also include parts assembly diagrams and
associated part numbers for all components that were removed from or
installed on the vehicle, a description of bow any computer programming
changes were completed, and a description of bow compliance was
verified after alterations were completed. Photographs (e.g., monitor
print screen captures) or report printouts, as practicable, must be
submitted as proof that any computer reprogramming was carried out
successfully.
    In addition to the information specified above, each conformity
package must also include evidence showing how the RI verified that any
changes it made in loading or reprograming vehicle software to achieve
conformity with each separate FMVSS did not cause the vehicle to fall
out of compliance with any other applicable FMVSS.

Decision

    Accordingly, on the basis of the foregoing, NHTSA hereby decides
that MY 2014 Ferrari LaFerrari PCs that were not originally
manufactured to comply with all applicable FMVSS are substantially
similar to 2014 Ferrari LaFerrari PCs manufactured for importation into
and/or sale in the United States, and certified under 49 U.S.C. 30115,
are capable of being altered to conform to all applicable FMVSS.

Vehicle Eligibility Number for Subject Vehicles

    The importer of a vehicle admissible under any final decision must
indicate on the form HS-7 accompanying entry the appropriate vehicle
eligibility number indicating that the vehicle is eligible for entry.
VSP-609 is the vehicle eligibility number assigned to MY 2014 Ferrari
LaFerrari PCs admissible under this notice of final decision.

    Authority: (49 U.S.C. 30141(a)(l)(A), (a)(l)(B), and (b)(l); 49
CFR 593.7; delegation of authority at 49 CFR 1.95 and 501.8)

Otto G. Matheke III,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2020-08149 Filed 4-16-20; 8:45 am]
BILLING CODE 4910-59-P


Chapter 12
Recordkeeping and Reporting
Contents
12.1	General	2
12.2	Notifications	3
12.3	Recordkeeping	3
12.4	Electronic Reporting	6
Compliance with Part 75 Reporting	6
New Reporting to ECMPS	7
Duplicative Reporting	8

General
Commenter 9664 asked that the reporting and recordkeeping provisions be changed. The commenter requested that the EPA change 60.46Da (h) and 60.46Da (i) be updated to include the following language, "any EGU meeting the standard through long-term containment in a subsurface geological formation (either through geologic sequestration or in enhanced oil recovery) [must] provide documentation showing that the volume of captured CO2 necessary to achieve the standard has been injected onsite to a facility permitted under the UIC program and reporting under Subpart RR [of Part 98], or transferred to a facility that is permitted under the UIC program and reports under Subpart RR." The commenter also asked that the reporting become a condition of the title V permit for the facility. 42 USC section 7661c(a).
As explained in section III.B of the final rule preamble, the EPA is combining the steam generator and combustion turbine categories into a single category of fossil fuel-fired electricity generating units for purposes of promulgating standards of performance for GHG emissions. The standards of performance for CO2 emissions will be codified in a new 40 CFR part 60, subpart TTTT. The EPA is not finalizing the co-proposed approach of codifying the standards of performance in the 40 CFR part 60, subparts Da and KKKK. Although the comment regards requested revisions to 40 CFR part 60, subpart Da provisions, a response to the substance of the comment in terms of subpart TTTT is provided. See Chapter 6 of this document for responses relating to 40 CFR Part 98 Subpart RR. See preamble section XII. Implications for PSD and Title V Programs for further discussion on PSD and Title V permits.
Comment 2: Commenter 8952 asked that the recordkeeping and reporting provisions be changed. The commenter recommended a few revisions to the recordkeeping and reporting requirements:
 change hourly fuel consumption rates to monthly fuel consumption
 change hourly generation data to monthly generation data
The commenter stated that the EPA could "gather these data directly without imposing an additional regulatory burden on facilities." The commenter noted that substantial amounts of these data are available through the EIA Electric Power Monthly.
The final rule does not require records of hourly fuel consumption or hourly generation to be kept as separate entities. However, for sources using Appendices D and G of Part 75 to demonstrate compliance, the quarterly Part 75 electronic emissions reports do require hourly fuel flow rates to be reported. And for all affected units, gross hourly electrical load is reported in the quarterly Part 75 electronic emissions data reports (EDRs).
Commenter 9427 asked "when do notification, recordkeeping, monitoring, and reporting requirements begin to apply?" The commenter recommended the following language, "Notifications, recordkeeping, monitoring, and periodic reporting requirements would be the responsibility of new stationary combustion turbine owners/operator that meet the 'three consecutive calendar years' applicability criteria."
In view of the changes to the applicability section of the rule, there is no need to provide any notices of applicability. Initial applicability is based solely on the design heat input capacity of the unit and the size of the electrical generator, and once a unit is identified as "affected", it remains in the program. Other notifications (i.e., the commencement of construction and unit startup notices in §60.7(a) and the applicable notifications in §75.61 shall be submitted within the time frames specified in those sections.
Notifications
Two commenters (9425 and 9666) supported the notifications required by the rulemaking.
The EPA acknowledges the commenters' support.
Two commenters (9425 and 9666) noted some duplicative notifications.
Commenters 9425 and 9666 stated, "EPA should exempt the notices in Section 75.61 from the duplicate reporting requirements in Section 60.4, which requires that all 'request, reports, applications, submittals, and other communications to the Administrator' be submitted 'in duplicate' to the appropriate EPA Regional Office and to any delegated state." Commenter 9666 noted that "section 75.61 already requires submission to those officials, there is no basis for requiring additional reporting 'induplicate' under Part 60."
Table 3 of the final rule clarifies that the notices under §75.61 are not subject to the submittal requirements of §60.4, and that duplicate submittals are not required for information that is subject to those requirements.
Recordkeeping
Commenter 9426 asked that the EPA specify what "maintaining records of calculations" means. The commenter wanted assurance that the EPA did not expect "sources to manually calculate all averages used for compliance with these rules, and then maintain hard copies of those calculations." The commenter asked that the EPA modify the rule so that "the rule is clear that computerized database records and calculations, with reporting verifications of equations such as required under 40 CFR Part 75, are acceptable."
The EPA agrees with the commenter. The final rule specifies that computerized (electronic) records are acceptable as long as they can be made readily available to inspectors and auditors upon request.
Commenters 9426 and 10023 commented on duplicative recordkeeping requirements. The commenters asked that the EPA "not impose any additional recordkeeping requirements that either duplicate Part 75 or go beyond what is required for Part 75."
The final rule does not require any duplicative recordkeeping between Parts 60 and 75. However, there are certain records that must be kept for the purposes of the NSPS (e.g., records of the calculations used for the compliance determinations), which are not required under Part 75.
Several commenters (9426, 9514, 9666, and 10023) offered recommendations related to electronic compliance records. One commenter (9426) asked that the EPA modify the language in paragraphs 60.46Da(i)(8) and 60.4391(h)(3) so that it is clear that electronic records are acceptable for the initial two years. Three commenters (9426, 9666, and 10023) asked for clarification on the terms "onsite" and "offsite" when related to recordkeeping. Commenter 9426 asked that the language be modified to indicate that electronic records can "be stored at an offsite location for the first two years as long as they are readily accessible onsite," while commenters 9666 and 10023 stated that "as long as the facility can access the information onsite, there is no reason for it to be physically located there."
Commenter 9514 stated that "EPA has not identified any particular (or even generalized) basis for its proposal to permit offsite storage after two years." The commenter asked that the EPA adopt additional language covering record retention. The commenter stated, "For example, under the subpart 98 reporting program for GHGs, records may be stored off site only 'if the records are readily available for expeditious inspection and review.' 40 C.F.R. Section 98.3(g). In addition, for any records stored electronically, 'the equipment or software necessary to read the records shall be made available, or, if requested by EPA, electronic records shall be converted to paper documents.' Id."
Commenter 9514 asked for clarification on the term "readily available." The commenter suggested "available on demand, not just to EPA, but to state and local authorities, irrespective of jurisdiction over the site where the records are stored, and to the general public."
As explained in section III.B of the final rule preamble, the EPA is combining the steam generator and combustion turbine categories into a single category of fossil fuel-fired electricity generating units for purposes of promulgating standards of performance for GHG emissions. The standards of performance for CO2 emissions will be codified in a new 40 CFR part 60, subpart TTTT. The EPA is not finalizing the co-proposed approach of codifying the standards of performance in the 40 CFR part 60, subparts Da and KKKK. Although the comment refers to 40 CFR part 60, subpart Da provisions, a response to the substance of the comment in terms of subpart TTTT is provided. The final rule requires that records be maintained for 3 years after the date of each occurrence, measurement, maintenance, corrective action, report or record. The final rule clarifies that each record must be kept on site or be accessible from a central location by computer or other means that instantly provide access at the site for at least 2 years after the date of each recorded action and may be kept off site for the remaining year(s).
Commenters 9666 and 10023 noted places in the proposed rule that contain unnecessary or duplicative recordkeeping provisions. Commenters 9666 and 10023 noted that the provisions in 60.7(b), 60.7(f), 60.5560(a), 60.4391(a) referring to startups and shutdowns have no basis to require records of those periods because there are no provisions in the NSPS that apply only to startup or shutdown. Commenter 9666 also opposed any recordkeeping requirements that are duplicative of Part 75, specifying 60.5560(b)-(d), 60.46 Da(i)(1), and 60.4391(b). This commenter (9666) asked that the EPA remove all recordkeeping provisions that refer to operating months because the compliance period is not monthly.
The final rule does not require any duplicative recordkeeping between Parts 60 and 75. However, there are certain records that must be kept for the purposes of the NSPS (e.g., records of the calculations used for the compliance determinations), which are not required under Part 75. The monthly recordkeeping requirements have been removed; rather, records must be kept for each "compliance period".
The final rule does not require records of startup and shutdown to be kept. The quarterly Part 75 electronic emissions reports show only hours in which the unit operated (combusted fuel). Unit startups and shutdowns are easily identified from the date and time stamps on the operating hours.
Commenter 9666 disagreed with the EPA's "5 year record retention period for all of the supporting information for the 12-operating-month rolling average standard, unless EPA can show a special need as required under the Paperwork Reduction Act regulations." The commenter recommended a 3-year record retention requirement to match part 75.
The EPA agrees that records should be maintained for 3 years after the date of each occurrence, measurement, maintenance, corrective action, report or record, and has revised the final rule accordingly.
Commenter 8957 asked that the EPA require the owner or operator to keep records that verify its applicability status. The commenter stated, "If the owner or operator considers themselves to be subject, they should keep all records and submit all reports as required by the rule on an annual basis. If the owner or operator does not consider themselves to be affected by the rule, they should only be required to keep records that verify that they are not subject to the rule. A reporting requirement for non-affected sources should not be required; records should be maintained for five years and reported to EPA or the permitting agency upon request."
In view of the changes to the applicability section of the rule, there is no need to provide any notices of applicability. Initial applicability is based solely on the design heat input capacity of the unit and the size of the electrical generator, and once a unit is identified as "affected", it remains in the program.
Electronic Reporting
Compliance with Part 75 Reporting
Two commenters (9425 and 9666) recommended changes to the reporting language.
Commenter 9425 noted that many combined cycle systems share a single turbine generator with two or more combustion turbines. The commenter suggested the following text be included in Section 60.4374(a)(3)(i):
      "The steam turbine output should be accounted for using one of the methods allowed in the Part 75 Policy Manual, Section 17.2 Unit Load Reporting:
       (1) For a combined-cycle unit (with or without auxiliary firing), if a single generator serves the CT and HRSG, report the electrical outputs (megawatts) from this generator.
      (2) For a combined-cycle unit (with or without auxiliary firing), if separate generators serve the CT and HRSG add the electrical outputs (megawatts) from these generators.
      (3) If the HRSG of two or more combined cycle units (CCUs) share a common steam turbine, then, for each CCU, add the electrical output (megawatts) from the generator that serves the CT to an apportioned fraction of the electrical output from the shared steam turbine. Apportion the combined electrical load from the common steam turbine to the individual CCUs according to the fraction of the total steam load contributed by each unit. Alternatively, if the turbines are identical, you may apportion the combined electrical load from the common steam turbine to the individual CCUs according to the fraction of the total heat input contributed by each unit."
Commenter 9666 noted that requiring compliance with "'all applicable reporting requirements in Part 75" in 60.5555(c), 60.46Da(h)(4), and 60.4376(d) is overly broad. The commenter suggested that the EPA "reword this provision to explain that 'applicable reporting requirements' means reporting of information needed to calculate lbs CO2/MWh - i.e., hourly load and any information used to calculate CO2 mass emissions." Commenter 9666 also noted that all of the data needed to calculate compliance already are recorded and reported under Part 75 and there is no reason to separately require any reporting under this NSPS until the calendar quarter that contains the end of the month that corresponds to the end of the first compliance period.
The final rule incorporates the Commenter 9425's suggestion to allow the electrical output of a common steam turbine to be apportioned to the individual EGUs according to fraction of the total steam load or (if the units are identical) based on the fraction of the total heat input to the EGUs.
The Agency has also incorporated Commenter 9666's recommendation to make the Part 75 reporting requirements more specific, i.e., that 'applicable reporting requirements' means reporting of information needed to calculate the CO2 mass emissions.
EPA agrees with Commenter 9666 that the first submission of a quarterly compliance reports should not be required until the initial 12-operating month compliance period has been completed. The final rule makes this clear.
New Reporting to ECMPS
Commenter 9425 asked that "EPA simply require reporting under Part 75. The reference to ECMPS is unnecessary and inappropriate."
The EPA disagrees with the commenter and believes it is necessary to call out ECMPS as the reporting mechanism in the regulation.
Commenter 9666 "does not object to reporting once a year the facility's gross electric output sold to an electric grid during the year, and the potential electric output of the facility."
The EPA thanks the commenter for their comment.
Commenters 9425 and 9666 asked that the EPA specify that the rule determines reporting requirements, not ECMPS. Commenter 9425 noted that the EPA referred to "other information" and "other modifications" that are not clearly specified. Commenter 9666 "would object to any attempt by EPA to use ECMPS to require reporting of any information, codes, calculations, or other information that is not identified both in the rule and in an ICR approved by OMB."
The EPA disagrees with the commenter and the reporting instructions contains "codes" and other instructions that are necessary to allow data to be submitted in a consistent manner for data elements that are required by the rule.
Commenters 9425 and 9666 commented on aspects of ECMPS that require clarification. Specifically, Commenter 9425 noted that CO2 data in ECMPS are reported hourly but the rule has a different compliance period. Additionally, commenter 9666 asked that the EPA specify reporting of CO2 in lb/MWh rounded to the nearest whole number consistent with ASTM rounding conventions and objected to the use of electronic auditing software within ECMPS to "impose on reporting facilities any requirements or quality assurance criteria that are not identified in the rule."
 The final rule specifies hourly reporting of CO2 consistent with 40 CFR part 75 and the EPA has expanded upon the requirements of reporting as it relates to both the rule and part 75 reporting. Compliance will be determined on a 12-operating month rolling average basis which is calculated using all of the hourly data reported to ECMPS.  Additionally, ECMPS does not impose "additional" QA/QC requirements but will provide electronic verification to ensure that data reported are consistent with the reporting requirements of the rule.
Commenter 9666 noted that §72.21(b)(2) requires that each submission under Part 75 be certified by the facility's DR, however this is not defined under Part 60. The commenter recommended that EPA modify ECMPS to allow certification for Part 60 data by the owner or operator instead of the DR as defined in Part 75.
 The final rule requires the DR under 72.2 to make the submissions and the EPA believes the final rule clarifies the commenters concern.
Duplicative Reporting
Commenters 9425 and 9666 asked that the EPA avoid duplicative reporting in the rule. Commenter 9425 asked for exemptions from part 60 QA/QC for sources using CEMS and to exempt ECMPS reports from the duplicate reporting requirements in §60.4. Additionally, Commenter 9666 asked to exempt Subparts Da and KKKK from §60.7(c) and exempt all electronic reporting requirements from §60.4.
The EPA is removing the requirement for any reporting under 60.4 that would be in duplicate to information that is reported electronically through ECMPS.
One commenter (9426) stated that reporting CH4 and N2O emissions under the NSPS would be duplicative with the GHGRP.
This rule does not require reporting of CH4 and N2O emissions.