14 The MDL is used currently to 15 legitimize reporting of data below 16 levels of calibration or reasonable 17 quantitation. Clients and regulators 18 treat these values as real numbers.

19 This is a little example here 20 of we have lab A which has got an MDL 21 of 2 ppb and reports a value of 2.6,

22 and lab B has got an MDL of 4 and 23 reports a value of ND. The client of 24 lab A may have to do more testing and 25 be out of compliance, whereas the one 142 1 for lab B, since they have a not 2 detect, is just find and dandy. They 3 don't do anything.

4 So, MDLs should be stated in 5 such a way as not to be used for 6 regulatory compliance.

7 I realize that we don't really 8 want... or the MDL procedure is for 40 9 CFR 136. In reality, everybody uses 10 it, drinking water, hazardous waste,

11 and we have got to realize that 12 whatever is finalized is going to be 13 used throughout the industry.

14 Definitions of the MDL must take into 15 account other regulatory uses besides 16 Clean Water Act, as we just stated a 17 few minutes ago.

18 Now, whether or not the MDL 19 should be based on a specific program 20 or not is another item that I kind of 21 question, because it states currently 22 in the procedure that spike levels may 23 be set based on regulatory objectives 24 rather than the actual method ability.

25 This gives you a lot of variety of 143 1 different spike levels which, in turn,

2 give you different MDLs.

3 The ACIL approach is based on 4 method rather than variable based on 5 different programs, and I agree with 6 that. Programs should set minimum 7 requirements that must be achieved and 8 all labs report to the minimum program 9 level rather than using the MDL and 10 use the MDL to show that it is 11 achievable but not on an ongoing 12 basis.

13 The definition of an MDL, it is 14 an estimate of the measured 15 concentration in which there is a 99 16 percent confidence level that any given 17 analyte is present in its sample 18 matrix. The MDL is the concentration 19 at which decision is made... these are 20 right out of the 40 CFR definition.

21 What I wanted to kind of focus 22 on is that word estimate. Regardless 23 of how many iterations, how many times 24 we run samples, it is always going to 25 be an estimated value. Whatever 144 1 manipulations we go through, they are 2 all estimated values.

3 MDLs apply only to the 4 conditions at the point in time when 5 the MDL study was done, and there is 6 no discussion regarding that.

7 Daily variations in instrument 8 conditions and sample matrices affect 9 MDLs over time. So, since we are 10 reporting down to the MDL, just doing 11 an MDL just doesn't quite cut it, and 12 I will get into that in a minute.

13 Can we simplify the process? I 14 may have a Polyanna kind of point of 15 view on it, but we are discussing,

16 since we are talking about estimated 17 values, let's see if we can simplify 18 it rather than make it more 19 complicated.

20 Can we simplify the process and 21 still achieve the desired end results?

22 I think we can.

23 As was discussed during the 24 ACIL presentation, there are a lot of 25 differences... actually it was brought 145 1 up in another one... there are large 2 differences in basic principles between 3 the different types of analyses, atomic 4 spectroscopy, chromatography,

5 gravimetric analysis, filtered versus 6 unfiltered. At least, the ACIL 7 approach does take into consideration 8 these variations, and I think it is a 9 good approach, rather than trying to 10 take one approach for it.

11 And we need to be able to 12 account for bias, and bias shows up 13 mostly, that I have seen, in methods 14 that require extractions. They tend 15 to be prone to bias. There is usually 16 some kind of loss. Benzadine is my 17 favorite case. That compound doesn't 18 recover worth beans.

19 But if you have got a low bias,

20 you are going to get an artificially 21 low method detection level. Actually,

22 I think our, quote, MDL for benzadine 23 calculates out to be something we will 24 never see, something less than 10 ppb 25 or something on that order, and it 146 1 doesn't matter what you spike it at.

2 You will never get it.

3 An MDL model must acknowledge 4 the issues related to bias. The ACIL 5 proposal is a good effort towards this 6 end.

7 The number of analytes in a 8 method, single analyte versus multi 9 analyte, and the number of instruments 10 used can have a bearing, a major 11 bearing, on the practicality and 12 economic feasibility of the approach.

13 As was discussed earlier, the number 14 of spike levels that a lab might have 15 to do to achieve the MDLs according to 16 the current procedure can be quite 17 excessive, and since we are doing this 18 on several instruments besides 19 different spike levels, this number 20 just gets multiplied.

21 The current procedure in the 22 Federal Register is to estimate the 23 detection limit and we are going to 24 take concentration approximately equal 25 to three times the standard deviation 147 1 of the replicate measurements of the 2 blank, or we take the lowest 3 concentration that can be detected by 4 analyzing samples containing 5 successively lower concentrations.

6 Like I said before about this being an 7 estimate, expanding on these items 8 would make for a very usable MDL, and 9 as was discussed earlier also in the 10 ACIL presentation, these two premises 11 are the whole basis for their 12 approach.

13 How often should MDLs be 14 performed? There is no discussion in 15 there whatsoever about that, and the 16 interpretation on how often they need 17 to be analyzed and verified is wide 18 open for interpretation.

19 Since MDLs are based on 20 conditions at a single point in time,

21 since we are reporting down to them 22 and actually trying to use those 23 numbers, they should be verified at a 24 regular frequence in some way, shape,

25 or form. Conditions change.

148 1 Right now, we have got a lot of 2 clients and regulators that have taken 3 the extreme approach, and they want 4 the full MDL studies on all 5 instrumentation annually. For our 6 laboratory, actually, the combination 7 of our three laboratories, and since 8 this crosses all programs and not just 9 the Clean Water Act, this costs us 10 between $ 400,000 and $ 500,000 a year 11 to do all these MDL studies. And we 12 need to simplify this. I mean, we 13 need to verify it, but we have got to 14 simplify it.

15 So, the current procedure is 16 estimate the lowest detectable amount,

17 and then we are going to seven times 18 the spike replicates at one to five 19 times that estimated MDL, and then the 20 MDL should be between 0.2 and 1 times 21 the spike amount which gets us back to 22 the first number in the first place,

23 the estimate. So, why go through all 24 these actions just to get us back to 25 the same number we started with? 149 1 Calculated MDLs based on 2 statistical models are theoretical only 3 and have the potential for being below 4 the actual detection. I constantly,

5 when we see papers being given on new 6 methods, new procedures, they will show 7 an MDL slide up there, and in a lot 8 of cases, if you look at the 9 calibration curve, the intercepts of 10 those curves don't match up with what 11 they are saying the MDLs are.

12 So, it is just a theoretical 13 number that doesn't have a whole lot 14 of meaning, but it is well documented.

15 So, data reported at or above the 16 calculated MDLs are of unknown,

17 although well documented, quality.

18 By basing the MDLs on a 19 function of the mean blank value plus 20 three standard deviations or actually 21 detected spike amounts, we can have an 22 MDL that could be supported by real 23 data rather than an MDL that is 24 theorized. Effective, flexible,

25 relatively simple, and affordable.

150 1 And thank you very much. 2 MR. TELLIARD: Thanks,

3 Scott. Our next speaker is Paul 4 Georgiou.

5 MR. GEORGIOU: I am Paul 6 Georgiou. I am here from Bran Luba 7 U. S. A. I am working on about four 8 weaknesses that I have. Usually, I 9 improvise speeches, and here I am with 10 a documented speech. So, if it 11 doesn't go that smoothly, you will 12 know why.

13 I also work for a Fortune 500 14 company, so that means I am doing the 15 work of five people, so I didn't have 16 enough time to prepare for this. I 17 found out about this at pit time, and 18 like I said, I have been working 19 through all the documentation since 20 then.

21 Also, I like walking around, so 22 I am going to be sitting here standing 23 in one place, and I usually take 24 questions as I am giving a speech,

25 because, normally, I am a trainer.

151 1 So, this is not what I am normally 2 used to.

3 But I am Paul Georgiou, a 4 senior applications chemist engineer 5 from Bran Luba U. S. A. This is the 6 company that was formerly known as 7 Technicon Industrial Systems. We 8 probably have more EPA approved methods 9 than just about anybody other than ICP 10 and things like that. We are a part 11 of SPX Process Equipment. If you want 12 to send me anything, the name you have 13 on there is 14 paul. georgiou@ bran luba. spx. com.

15 I have 13 years' experience 16 running inorganic chemistries for the 17 EPA, Waste Management, and Bran Luba.

18 This kind of gives me a unique 19 understanding of the way all three 20 work, because I have worked for the 21 EPA, and I have worked for industry,

22 and I have worked for an instrument 23 manufacturer. In all three positions,

24 I have run hundreds of MDLs.

25 One statement of that is when I 152 1 worked for Waste Management, we were 2 doing some of the COP protocols. We 3 would do three MDLs on all the ICP 4 methods for three days in a row. So,

5 just alone there, we were running, I 6 don't know, 200, 300 every 6 months.

7 So, I have a lot of experience running 8 the MDLs.

9 I am currently an applications 10 chemist for the autoanalyzer II,

11 autoanalyzer III, and other 12 colorimetric systems. Additionally, I 13 have responsibility for the regulatory 14 compliance of North America.

15 Once I heard about EPA changing 16 its MDL definitions, I was quite 17 interested in the discussions. As I 18 told you, I have done hundreds of 19 these MDLs.

20 I recall slaving over an AA2 21 with exacting standards trying to get 22 an acceptable MDL for my supervisors.

23 I have not let my former animosity 24 change my opinion of what has been 25 going on here.

153 1 I started looking through the 2 reams of paper. I went on the 3 Internet, did all the research in 4 this, and, actually, I have a good 5 quantity of comments which I won't go 6 into, but I will give the information 7 to the EPA, but I have since turned 8 into a support. I will give you the 9 three reasons why in just a minute,

10 but I concur with the peer reviewers. 11 Each one of these MDLs, there 12 are strengths and weaknesses to each 13 one of them, but the fact is that 14 most industry has been using this for 15 probably 20 or 30 years. There are 16 weaknesses. For instance, if you talk 17 about a linear curve, as the gentleman 18 just said before, you know, where it 19 crosses the axis, y= mx+ b, if you have 20 a negative slope, your blanks will be 21 negative which is also I made a 22 statement of that later in my talk.

23 I kind of relate the MDL 24 discussion to who created the largest 25 tax increase in history, which 154 1 President. Well, according to Bill 2 Clinton, it was George Bush 41. Then,

3 according to who Bob Dole, it was 4 actually Bill Clinton.

5 As a scientist, I always 6 wondered, how can two completely 7 opposite statements be true? So, I 8 did some investigation. What I found 9 out was that Bill Clinton had the 10 largest tax increase in straight 11 dollars, but corrected for inflation,

12 George Bush 41 did. So, we have two 13 completely opposite statements which 14 are both technically true.

15 I kind of see the MDL 16 discussion the same way. Once again,

17 industry... like I said, there were some 18 great talks here. Each one of them I 19 have seen, you know, as it crosses 20 through zero. I have done statistical 21 analysis across the entire curves using 22 zero. I was thinking that if you did 23 the entire curve, you would get a 24 higher MDL than just using someplace 25 around the detection limit.

155 1 Well, as I looked at each of 2 the different methods, each of the 3 different methods was different. Some 4 had a higher MDL; some had a lower 5 MDL. So, I think it is all kind of a 6 discussion. How you treat your data 7 is essentially how you are going to 8 come up with your MDL.

9 But what I do like about the 10 current MDL is it is universal. I 11 said no matter how much money your 12 laboratory has or how little money 13 your laboratory has, you are all able 14 to do it. And just as a gentleman 15 said this morning, I never thought 16 about the titrametric methods. You 17 know, I am doing an automated method,

18 but it is true it is a lot more 19 difficult to run those methods than it 20 is to run an automated system.

21 So, it is all dependent on, you 22 know, what you are doing with your 23 system.

24 Second of all, with some of the 25 changes that are made, as you are able 156 1 to correct for blanks or force the 2 curve through zero, as long as it is 3 stated in your method, you are able to 4 use that. That will take into account 5 that.

6 We have seawater methods which 7 have high part per trillion detection 8 methods. Then, we go out to a 9 laboratory, and they start using it,

10 but this is mainly used in seawater,

11 so they want to see 10 ppb accurately,

12 and then, when they start running it,

13 they see 12 ppb, but they know,

14 because they have been running the 15 same samples over and over and over 16 again, that it is 10 ppb.

17 So, it just so happened that 18 there was an offset in the blank of 2 19 ppb. Due to the regulations right 20 now, they don't really state whether 21 you can correct for that blank or 22 force it through zero. So, that is 23 another way the MDLs can be changed.

24 Also, using the ML which is ten 25 times the standard deviation, it gives 157 1 a better argument as far as what is a 2 real concentration. Once you take 3 into account, you know, the blank and 4 where all that stuff is, once you take 5 the standard deviation of that number,

6 you multiply it by ten, and you get a 7 much more believable number.

8 One of my favorite examples 9 inside my industry, there is the 10 phenol colorimetric method. It states 11 that you can get a... certain regulatory 12 agencies state you can get a 1 ppb 13 detection limit. Well, me 14 who is in this industry and sells the 15 instruments say I have never reliably 16 seen that. So, like I said, our 17 instruments can probably do 2 or 3 18 ppb, but still, in certain regulations,

19 that is what it states, but that was 20 because it was a regulatory 21 concentration, not whether or not the 22 instrument could do it. 23 So, when I sell instruments to 24 get the 1 ppb detection limit,

25 usually, I said well, it probably 158 1 can't be done, but you can probably 2 get 2 or 3. So, otherwise, we haven't 3 sold too many of those instruments 4 lately.

5 I have one example. Like I 6 said, I have put all this 7 documentation. It will probably be 8 whatever they put on the Internet in 9 the future, but I have an MDL study of 10 what I did at a customer's site.

11 I went out to a customer's 12 site. Oh, this instrument is a piece 13 of garbage, and they couldn't get 14 their detection limit. They were 15 looking for a deviation in their blank 16 of plus or minus 10 ppb. Through 17 experience, what I have found out is 18 usually... which was stated also in one 19 of the presentations earlier 20 today... that a deviation in the blank 21 is usually higher than your detection 22 limit. I just found that through 23 experience.

24 But what I did find is I was 25 running these samples. I got a 159 1 0.0174, 0.0169, 0.0173, roughly, around 2 20 ppb. I got a standard deviation of 3 0.3 ppb which was within their, you 4 know, limits. I said, to be quite 5 honest with you, this is the best run 6 I have ever seen in my life. I got a 7 1 ppb detection limit with a 1 ppm 8 high standard.

9 I have this thing what I call 10 Georgiou's thesis which customers ask 11 what detection limit can you get.

12 Inside the colorimetric industry, if 13 you are using a 1 ppm high standard,

14 chances are you should probably get a 15 10 ppb detection limit. On our AA3 16 system, we are actually able to do 17 half of that, but, you know, using 18 that statement, I was running a 1 ppm 19 high standard on total phos. So, it 20 is even digested. I got a 1 ppb 21 detection limit, and, eventually, they 22 came back to me and said well, this is 23 no good, the QC is out.

24 The concentrations I was 25 seeing, the 0.0174, was actually only 160 1 an 85.9 percent recovery. Problem 2 number one. They were doing drinking 3 water, so it is supposed to be plus or 4 minus 10 percent. So, they basically 5 threw the data out because of that.

6 Second of all, the 7 concentration of the MDL was too high.

8 If you look at the way it results now,

9 you are supposed to use three to five 10 times the MDL. So, with a 1 ppb 11 detection limit, I used a 20 ppb. So,

12 once again, I had to throw this 13 data out, because the concentration was 14 too high.

15 And, last, as I stated before,

16 the blank results were deviating more 17 than the actual replicates.

18 I think most of this can be 19 taken into account with the new 20 changes that are being recommended by 21 the EPA. Like I said, if you can use 22 zero forcing or zero correction or 23 things like that, I think that will 24 have a larger effect on what results 25 you get rather than what is actually 161 1 calculated.

2 Thank you.

3 MR. TELLIARD: Thanks,

4 Paul.

5 The Metropolitan Water 6 Reclamation District of Greater Chicago 7 will not be presenting this afternoon,

8 so that brings to a close this public 9 meeting.

10 The closing date for comments 11 is July 10th. Please keep those 12 letters and cards coming in. Any 13 checks you want to send for gifts,

14 because you really like it, will be 15 appreciated, because our budget is 16 really low this year.

17 So, thanks for coming today.

18 The information in question is up on 19 our website if you want to take a look 20 at it. If you have any questions on 21 getting your comments in or anything 22 else, feel free to give us a call.

23 Thanks for your attention. I 24 want to thank the speakers for taking 25 the time to give us their comments. 162 1 Have a good day.

2 ( WHEREUPON, the Proceedings were 3 concluded.)

4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 163 1 CAPTION 2 .

3 The Public Meeting in the 4 matter, on the date, and at the time 5 and place set out on the title page 6 hereof.

7 .

8 It was requested that the 9 Meeting be taken by the reporter and 10 that the same be reduced to 11 typewritten form.

12 13 14 15 16 17 18 19 20 21 22 23 24


[Federal Register Volume 78, Number 117 (Tuesday, June 18, 2013)]
[Notices]
[Pages 36557-36558]
[FR Doc No: 2013-14493]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4118-DR; Docket ID FEMA-2013-0001]

North Dakota; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of North Dakota (FEMA-4118-DR), dated May 29,
2013, and related determinations.

DATES: Effective Date: May 29, 2013.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated May 29, 2013, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of North Dakota resulting from flooding during the period of April
22 to May 16, 2013, is of sufficient severity and magnitude to
warrant a major disaster declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq.
(the ``Stafford Act''). Therefore, I declare that such a major
disaster exists in the State of North Dakota.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as

you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Gary R. Stanley, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of North Dakota have been
designated as adversely affected by this major disaster:

    Benson, Bottineau, Cass, Cavalier, Eddy, Foster, McHenry,
Pembina, Ramsey, Renville, Richland, Rolette, Towner, Traill, Walsh,
and Wells Counties and the Spirit Lake Reservation for Public
Assistance.
    All counties within the State of North Dakota are eligible to
apply for assistance under the Hazard Mitigation Grant Program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2013-14493 Filed 6-17-13; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 78, Number 159 (Friday, August 16, 2013)]
[Rules and Regulations]
[Pages 49923-49925]
[FR Doc No: 2013-19979]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2013-0648]
RIN 1625-AA00

Safety Zone; D-Day Conneaut, Lake Erie, Conneaut, OH

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on
Lake Erie, Conneaut, OH. This safety zone is intended to restrict
vessels from a portion of Lake Erie during the D-Day Conneaut event.
This temporary safety zone is necessary to protect mariners and vessels
from the navigational hazards associated with a historical re-
enactment.

DATES: This rule will be effective from 3 p.m. August 16, 2013, to 5
p.m. August 17, 2013. On August 16, 2013, this rule will be enforced
from 3 p.m. to 5 p.m. On August 17, 2013, this rule will be enforced
from 2 p.m. to 5 p.m., or until all vintage U.S. fighter planes leave
the area.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2013-0648]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LT Christopher Mercurio, Chief of Waterways Management,
U.S. Coast Guard Sector Buffalo; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing
the docket, call Barbara Hairston, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
TFR Temporary Final Rule

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable and
contrary to the public interest. The final details for this event were
not known to the Coast Guard until there was insufficient time
remaining before the event to publish an NPRM. Thus, delaying the
effective date of this rule to wait for a comment period to run would
be both impracticable and contrary to the public interest because it
would inhibit the Coast Guard's ability to protect spectators and
vessels from the hazards associated with a historic re-enactment, which
are discussed further below.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this temporary rule effective less than 30 days after
publication in the Federal Register. For the same reasons discussed in
the preceding paragraph, waiting for a 30 day notice period to run
would be impracticable and contrary to the public interest.

B. Basis and Purpose

    From 4 p.m. to 4:30 p.m. on August 16, 2013, and from 3 p.m. to 4
p.m. on August 17, 2013, or until all vintage

U.S. fighter planes leave the area, there will be vintage U.S. fighter
plane demonstrations and historic re-enactments of WWII landing craft
on and over the Conneaut Township Park Lakefront area. This event will
taking place over a portion of Lake Erie near Conneaut, OH. The Captain
of the Port Buffalo has determined that the historic re-enactments
combined with a high concentration of recreational vessels will create
significant risk to public safety and property.

C. Discussion of the Temporary Final Rule

    With the aforementioned hazards in mind, the Captain of the Port
Buffalo has determined that this temporary safety zone regulation is
necessary to ensure the safety of spectators and vessels during the D-
Day Conneaut. On August 16, 2013, this regulation will be enforced from
3 p.m. to 5 p.m. On August 17, 2013, this regulation will be enforced
from 2 p.m. to 5 p.m., or until all vintage U.S. fighter planes leave
the area. The safety zone established by this rule covers waters of
Lake Erie near Conneaut, OH encompasses by a line starting at position
41[deg]57.71' N and 080[deg]34.18' W, then to 41[deg]58.36' N and
080[deg]34.17' W, then to 41[deg]58.53' N and 080[deg]33.55' W, then to
41[deg]58.03' N and 080[deg]33.72' W and returning to the point of
origin (NAD 83).
    Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port Buffalo or his
designated on-scene representative. The Captain of the Port or his
designated on-scene representative may be contacted via VHF Channel 16.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. It is not
``significant'' under the regulatory policies and procedures of the
Department of Homeland Security (DHS).
    We conclude that this rule is not a significant regulatory action
because we anticipate that it will have minimal impact on the economy,
will not interfere with other agencies, will not adversely alter the
budget of any grant or loan recipients, and will not raise any novel
legal or policy issues. The safety zone created by this rule will be
relatively small and enforced for relatively short time. Also, the
safety zone is designed to minimize its impact on navigable waters.
Furthermore, the safety zone has been designed to allow vessels to
transit around it. Thus, restrictions on vessel movement within that
particular area are expected to be minimal. Under certain conditions,
moreover, vessels may still transit through the safety zone when
permitted by the Captain of the Port.

2. Impact on Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered the impact of this proposed rule on small entities. The
Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule
will not have a significant economic impact on a substantial number of
small entities. This rule will affect the following entities, some of
which might be small entities: the owners or operators of vessels
intending to transit or anchor in a portion of Lake Erie from 3 p.m. to
5 p.m. on August 16, 2013, and from 2 p.m. to 5 p.m. on August 17,
2013, or until all vintage U.S. fighter planes leave the area.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons: This
safety zone would be activated, and thus subject to enforcement, for
only few hours each day over two days. Traffic may be allowed to pass
through the zone with the permission of the Captain of the Port. The
Captain of the Port can be reached via VHF channel 16. Before the
activation of the zone, we would issue local Broadcast Notice to
Mariners.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and

Interference with Constitutionally Protected Property Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves the establishment of a safety zone and,
therefore it is categorically excluded from further review under
paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An
environmental analysis checklist supporting this determination and a
Categorical Exclusion Determination are available in the docket where
indicated under ADDRESSES. We seek any comments or information that may
lead to the discovery of a significant environmental impact from this
rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and record
keeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR parts 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T09-0648 to read as follows:

Sec.  165.T09-0648  Safety Zone; D-Day Conneaut, Lake Erie, Conneaut,
OH.

    (a) Location. This zone will covers those waters of Lake Erie near
Conneaut, OH encompassed by a line starting at position 41[deg]57.71' N
and 080[deg]34.18' W, then to 41[deg]58.36' N and 080[deg]34.17' W,
then to 41[deg]58.53' N and 080[deg]33.55' W, then to 41[deg]58.03' N
and 080[deg]33.72' W and returning to the point of origin (NAD 83).
    (b) Enforcement periods. This section will be enforced from 3 p.m.
to 5 p.m. on August 16, 2013, and from 2 p.m. to 5 p.m. on August 17,
2013, or until all vintage U.S. fighter planes leave the area.
    (c) Regulations. (1) In accordance with the general regulations in
section 165.23 of this part, entry into, transiting, or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port Buffalo or his designated on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Buffalo or his designated on-
scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port
Buffalo is any Coast Guard commissioned, warrant or petty officer who
has been designated by the Captain of the Port Buffalo to act on his
behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zone shall contact the Captain of the Port Buffalo or his on-scene
representative to obtain permission to do so. The Captain of the Port
Buffalo or his on-scene representative may be contacted via VHF Channel
16. Vessel operators given permission to enter or operate in the safety
zone must comply with all directions given to them by the Captain of
the Port Buffalo, or his on-scene representative.

    Dated: July 29, 2013.
B. W. Roche,
Captain, U.S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. 2013-19979 Filed 8-15-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)]
[Notices]
[Pages 51252-51253]
[FR Doc No: 2015-20855]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC15-13-000]

Commission Information Collection Activities (FERC-912); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Notice of information collection and request for comments.

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

SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, 44 U.S.C. 3506(c)(2)(A), the Federal Energy Regulatory
Commission (Commission or FERC) is soliciting public comment on the
currently approved information collection, FERC-912, Cogeneration and
Small Power Production, PURPA Section 210(m) Regulations for
Termination or Reinstatement of Obligation to Purchase or Sell.

DATES: Comments on the collection of information are due October 23,
2015.

ADDRESSES: You may submit comments (identified by Docket No. [IC15-13-
000]) by either of the following methods:
     eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/resources/guides/submission-guide.asp. For user assistance, contact
FERC Online Support by email at<EMAIL_ADDRESS>or by phone
at<PHONE_NUMBER> (toll-free) or at<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket, or in viewing/downloading comments and
issuances in this docket, may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>by telephone at<PHONE_NUMBER>, and by fax at
(202) 273-0873.

SUPPLEMENTARY INFORMATION:
    Title: FERC-912, Cogeneration and Small Power Production, PURPA
Section 210(m) Regulations for Termination or Reinstatement of
Obligation to Purchase or Sell.
    OMB Control No.: 1902-0237.
    Type of Request: Three-year extension of the FERC-912 information
collection requirements with no changes to the current reporting
requirements.
    Abstract: On 8/8/2005, the Energy Policy Act of 2005 (EPAct 2005)
\1\ was signed into law. Section 1253(a) of EPAct 2005 amends Section
210 of the Public Utility Regulatory Policies Act of 1978 (PURPA) by
adding subsection ``(m),'' that provides, based on a specified showing,
for the termination and subsequent reinstatement of an electric
utility's obligation to purchase from, and sell energy and capacity to,
qualifying facilities (QFs). 18 CFR 292.309-292.313 are the
implementing regulations, and provide procedures for:
---------------------------------------------------------------------------

    \1\ Public Law 109-58, 119 Stat. 594 (2005).
---------------------------------------------------------------------------

     An electric utility to file an application for the
termination of its obligation to purchase energy and capacity from, or
sell to, a QF; \2\ and
---------------------------------------------------------------------------

    \2\ Contained within 18 CFR 292.310 and 292.312.
---------------------------------------------------------------------------

     An affected entity or person to subsequently apply to the
Commission for an order reinstating the electric utility's obligation
to purchase energy and capacity from, or sell to, a QF.\3\
---------------------------------------------------------------------------

    \3\ Contained within 18 CFR 292.311 and 292.313.
---------------------------------------------------------------------------

    Type of Respondents: Electric utilities, principally.
    Estimate of Annual Burden: \4\ The Commission estimates the total
Public Reporting Burden for this information collection as:
---------------------------------------------------------------------------

    \4\ The Commission defines burden as the total time, effort, or
financial resources expended by persons to generate, maintain,
retain, or disclose or provide information to or for a Federal
agency. For further explanation of what is included in the
information collection burden, reference 5 Code of Federal
Regulations 1320.3.

 FERC-912--Cogeneration and Small Power Production, PURPA Section 210(m) Regulations for Termination or Reinstatement of Obligation To Purchase or Sell
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          Annual  number                      Average      Total annual
                                                             Number of     of  responses   Total number     burden and     burden hours      Cost per
                                                            respondents         per        of responses      cost per        and total    respondent ($)
                                                                            respondent                     response \5\     annual cost
                                                                     (1)             (2)     (1) * (2) =             (4)     (3) * (4) =       (5) / (1)
                                                                                (3)                             (5)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Termination of obligation to purchase...................               5               1               5        12, $864      60, $4,320            $864

Reinstatement of obligations to purchase................               0               0               0           0, $0           0, $0               0
Termination of obligation to sell.......................               0               0               0           0, $0           0, $0               0
Reinstatement of obligation to sell.....................               0               0               0           0, $0           0, $0               0
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............      60, $4,320             864
--------------------------------------------------------------------------------------------------------------------------------------------------------
\5\ The estimates for cost per response are derived using the following formula: Average Burden Hours per Response * $72.00 per Hour = Average Cost per
  Response. The hourly cost figure comes from the FERC average salary ($149,489/year). Commission staff believes the FERC average salary to be
  representative wage for industry respondents.

    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: August 18, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-20855 Filed 8-21-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 34 (Tuesday, February 21, 2012)]
[Notices]
[Pages 9944-9945]
[FR Doc No: 2012-3954]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-P-0170]

Determination That REQUIP XL (Ropinerole Hydrochloride) Extended-
Release Tablets, 3 Milligrams, Were Not Withdrawn From Sale for Reasons
of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined that
REQUIP XL (ropinerole hydrochloride) extended-release tablets, 3
milligrams (mg), were not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for ropinerole hydrochloride extended-
release tablets, 3 mg, if all other legal and regulatory requirements
are met.

FOR FURTHER INFORMATION CONTACT: Jay Sitlani, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6370, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA). The only clinical data
required in an ANDA are data to show that the drug that is the subject
of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness
(Sec.  314.162 (21 CFR 314.162)).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    REQUIP XL (ropinerole hydrochloride) extended-release tablets, 3
mg, are the subject of NDA 22-008, held by GlaxoSmithKline, and
initially approved on June 13, 2008. REQUIP XL is indicated for the
treatment of treatment of signs and symptoms of idiopathic Parkinson's
disease.
    REQUIP XL (ropinerole hydrochloride) extended-release tablets, 3
mg, are currently listed in the ``Discontinued Drug Product List''
section of the Orange Book. GlaxoSmithKline has never marketed REQUIP
XL (ropinerole hydrochloride) extended-release tablets, 3 mg. In
previous instances (see, e.g., 72 FR 9763, 61 FR 25497), the Agency has
determined that, for purposes of Sec. Sec.  314.161 and 314.162, never
marketing an approved drug product is equivalent to withdrawing the
drug from sale.
    Lachman Consultant Services, Inc. submitted a citizen petition
dated April 1, 2009 (Docket No. FDA-2009-P-0170), under 21 CFR 10.30,
requesting that the Agency determine whether REQUIP XL (ropinerole
hydrochloride) extended-release tablets, 3 mg, were withdrawn from sale
for reasons of safety or effectiveness.

    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that REQUIP XL (ropinerole hydrochloride) extended-
release tablets, 3 mg, were not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that REQUIP XL (ropinerole hydrochloride)
extended-release tablets, 3 mg, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of REQUIP XL (ropinerole hydrochloride)
extended-release tablets, 3 mg, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have found no information that would indicate that
this product was withdrawn from sale for reasons of safety or
effectiveness.
    Accordingly, the Agency will continue to list REQUIP XL (ropinerole
hydrochloride) extended-release tablets, 3 mg, in the ``Discontinued
Drug Product List'' section of the Orange Book. The ``Discontinued Drug
Product List'' delineates, among other items, drug products that have
been discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to REQUIP XL (ropinerole hydrochloride)
extended-release tablets, 3 mg, may be approved by the Agency as long
as they meet all other legal and regulatory requirements for the
approval of ANDAs. If FDA determines that labeling for this drug
product should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.

    Dated: February 14, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3954 Filed 2-17-12; 8:45 am]
BILLING CODE 4160-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

 National Vehicle and Fuel Emissions Laboratory

                              2565 Plymouth Road

                    Ann Arbor, Michigan 48105-2498

											OFFICE OF

										      AIR AND RADIATION

September 29, 2008

MEMORANDUM

FROM:  	Todd Sherwood

Assessment and Standards Division, US EPA

TO:	   	Docket ID No. EPA-HQ-OAR-2005-0047

SUBJECT:	Meetings with Ford

Meeting Dates

EPA staff met with representatives of Ford on the following days:

June 9, 2008

July 8, 2008

EPA Attendees

EPA staff in attendance at the meetings were:

Brian Nelson (6/9/08, 7/8/08)

Robert Peavyhouse (6/9/08)

Anthony Neam (6/9/08)

Hugh Harris (6/9/08)

Todd Sherwood (6/9/08)

Ford Attendees

Ford representatives in attendance at the meeting were:

John Trajnowski (6/9/08, 7/8/08)

Michiel Van Nieuwstadt (6/9/08)

John Bogama (6/9/08, 7/8/08))

Linda Camaj (6/9/08, 7/8/08))

Andre Welch (6/9/08, 7/8/08)

Ken McAlinden (6/9/08, 7/8/08)

Topics Discussed

Topics discussed at this meeting were:

Ford’s NOx aftertreatement monitoring capability

Ford’s monitoring of a DOC’s ability to generate the necessary feedgas for other aftertreatment devices.

Ford’s DPF monitoring capabilities and test data

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