21 One suggestion of a way to perhaps move this 22 forward is in the monitoring area or if there are 116 1 additional talk related studies that haven't been 2 dealt with, we could agree to discuss at the next 3 plenary scope elements of what such a monitoring 4 program might involve. EPA and other interested 5 parties could develop our thinking and try to bring 6 that forward to allow for an informed discussion, the 7 proposal that we offered in our Framework to remind 8 everyone was to use the 3M and DuPont monitoring as a 9 starting point for those discussions.

10 I think my view on it is that this could be a 11 very difficult and complex area and our thinking is 12 that what we might to attempt to do initially is to 13 develop an agreement as it relates to almost a 14 screening level of assessment at sites, the 3M and 15 DuPont studies tend to be more best in order  or the 16 protocols do. Rather than now attempting to develop 17 what might be follow up work for more comprehensive 18 work that's appropriate in specific areas, and so this 19 could evolve, for example, doing the work at 20 representative sites, you would have to talk about 21 what that would mean. It would mean work that we can 22 to attempt to comprehensively characterize but attempt 117 1 to provide a more initial level of understanding which 2 after that work is done it could be evaluated as 3 appropriate additional more detailed work could be 4 pursued in subsequent ECA discussions, so that at 5 least one way that we could carry the issue into the 6 next plenary discussion. So if there is any reaction 7 to that or if there are better ideas out there, we are 8 certainly open to that. So I will let you think about 9 that for while.

10 One of the other areas where  and I draw this 11 to your attention because it would be one of the 12 points that would need to be addressed here  is 13 biodegradation, degradation studies that wasn't 14 included in the early agreement work that we talked 15 about, so that's another one of the areas that we need 16 to consider here, so you might think about approaches 17 in bringing that work back.

18 It may make sense  I mean I test this in the 19 group  would you like to take a break and allow 20 groups to caucus? Before we rush to that, if there 21 are any other approaches that interested parties would 22 like to offer as to the way we might tee this issue up 118 1 at the next plenary, I don't want to take the one 2 proposal and run with it, is there any other ways that 3 interested parties would like others to consider 4 during this caucus break, I would invite those 5 interventions now, so if there is anything there, any 6 comment as we look carefully. All right. Why don't 7 we  it's now about 3: 30, why don't we come back in 8 20 minutes, is that enough time for groups to caucus 9 and to think about how we might feel with these issues 10 in subsequent plenary discussion, so with that we're 11 adjourned for the next 20 minutes.

12 ( Short break.)

13 MR. OSHIDA: I would like to call your 14 attention to we tried to summarize on the flip chart.

15 The three groups that we feel that we agreed to and 16 the issues that have been moved into the technical 17 groups. We hope to make some more progress, but this 18 is what we've got so far. When you get a chance take 19 a look at it and see if you agree that this is where 20 we are.

21 MS. SMYTHE: The TRP would like to suggest that 22 with the items in the ECA that relate to the telomer 119 1 data needs that we would like to move that discussion 2 directly into technical groups, all the ECA items that 3 are listed, with that being a staging area and a 4 discussion area for the technical details that can be 5 brought back to the plenary session whenever that 6 occurs. The exception would be ECA item 11 as it 7 relates to the TRP, which relates to the fire fighting 8 foams and we will let that be handled by others, so 9 ECA item 11 as it relates to TRP we would not be a 10 participant in that particular ECA, but the rest we 11 would suggest that they go straight to technical 12 groups.

13 MR. DUNCAN: We had tried put some the of low 14 hanging fruit up there that might be good candidates 15 for the early ECA things, but after caucusing I think 16 we would like to take one of the tougher items that 17 we've got which is item 10 in the fluoropolymers 18 Framework. And what I would like to do is to maybe 19 share with the rest of the group how the 20 Fluoropolymers Manufacturers Group sees this issue 21 because this is probably one of the most complex 22 segments that we have in all of the 11 items that you 120 1 got and plus all of the activities that involve the 2 entire PFOA area. So if I could, I would like to 3 maybe read in somewhat in a summary fashion how we 4 would like to address this.

5 We think it is fairly comprehensive and if 6 there's a discussion on that we would be more than 7 delighted to listen to it and if there's a need to 8 take this beyond what we're suggesting, perhaps this 9 could be separate candidate for a separate technical 10 committee itself simply because of the extreme 11 complexity and diversity of this particular issue. So 12 if I can, I would like to share with you our 13 perspective items.

14 First of all, item 10 calls for release and 15 exposure assessments adjacent to PFOA and 16 fluoropolymer manufacturing and use facilities, also 17 of control areas. The FMG supports the need for 18 release exposure assessments adjacent to such 19 facilities, as such, and we'll make some comments and 20 I'll try to simplify from the standpoint of referring 21 back to the LOI, but as such in the LOI we have 22 committed to conduct an exposure assessment adjacent 121 1 to the new APFO manufacturing facility that has just 2 been constructed, of course DuPont has responsibility 3 for that and they have submitted a complete workplan 4 for this effort to EPA based on the workplan that was 5 developed in West Virginia. So there's a model there 6 we'll be following and that model will be used in and 7 for  is being used now for the APFO manufacturing 8 facility being constructed in North Carolina.

9 Similarly the FMG is committed to conducting 10 exposure assessment adjacent to a representative 11 sample of fluoropolymer manufacturing facilities in 12 the U. S. The protocol, these assessments will be based 13 upon the protocol developed and approved by the states 14 of West Virginia and Ohio along with region 3 and 5 of 15 the U. S. EPA. The entire workplan, quality assurance 16 plan, and results of the study in the area of the 17 possible Washington Works have been submitted to the 18 EPA record. This workplan includes sampling of 19 surface water as well as ground water and soil 20 sampling.

21 And finally, the FMG is committed to conducting 22 material balance assessment in representative 122 1 fluoropolymer dispersion processing customers, these 2 are our downstream customers who take the polymers 3 produced by the resin manufacturers and convert them 4 into products. The fluoropolymer dispersion customers 5 assessment will be based on an industry developed 6 protocol using appropriate methods. For example,

7 there is an OPPT 2003 OO12 OO40. Since dry resin is 8 not expected to contain any significant amount of 9 PFOA, the FMG does not feel that the appropriate 10 include dry resin processes at this time.

11 So what we are going to do is go after the 12 processors that would have the highest expectation of 13 potentially having the emissions, do those and if 14 appropriate do something else later on. The FMG 15 supports the overall attempt of item 10 and believes 16 the critical elements of item 10 are basically 17 included in our LOI, but again that definition of 18 what's appropriate I think is one of these things that 19 we look forward to having further discussion with the 20 EPA and other parties, but as I say, this is an 21 extremely complex area.

22 And just to kind of summarize it, if you look 123 1 at the supply chain aspect of the PFOA trail starting 2 with the APFO producer, the fluoropolymer producers 3 and then the downstream processors, we think on the 4 top two tiers of that we've a pretty good 5 comprehensive analysis program to review for you and 6 we've got the beginnings of an analysis program of 7 processors to see if there are issues at that level as 8 well.

9 So we consider this to be one of the biggest 10 area of activities we've got in terms of the 11 characterization of the PFOA influence, if you will,

12 from those sites. We think it is pretty 13 comprehensive, it has been adopted in two states now,

14 and we are actively engaged in implementing it in 15 those areas.

16 So I just wanted to share not only with the 17 EPA, but other people involved here what is already in 18 place and my comment would be if there's more that's 19 needed we are certainly willing to consider it and 20 deal with it on a technical basis. But we wanted to 21 make sure if there was a discussion on this subject we 22 at least had the benefit of what is already in place. 124 1 Thank you very much.

2 MR. AUER: So as I understand it what you're 3 suggesting is that I offer this for consideration by 4 the group, as I understand it, to form a technical 5 committee, a separate technical committee. And it 6 sounds like what you're proposing to do is to explain 7 to that group what you anticipate doing under the 8 monitoring program for the purposes of your LOI and,

9 that would fully inform this technical group as to the 10 scope of that activity and the sites and appropriate 11 details on the monitoring procedures and whatnot, and 12 then that group could then consider whether there are 13 any additional needs that they would like to raise,

14 and it would be those additional needs that might be 15 appropriate for consideration within the Framework of 16 the ECA.

17 And so the starting point is to educate this 18 technical group as to what your LOI delivers and then 19 with that understanding what additional work might be 20 necessary. Is that the case?

21 MR. DUNCAN: I mean, we can live with that. We 22 can live with that. 125 1 MR. AUER: Any comment on that with EWG?

2 MS. THAYER: It sounds like a fine process and 3 we are just sort of hoping that I'm not sure of the 4 amount of information would be given to the technical 5 group, but it would be nice to have sort of a broad 6 list of manufacturing sites. I'm not sure if we would 7 just be presented with the candidate sites, but it 8 would be nice to have a comprehensive list and then 9 may be how they were selected.

10 MR. AUER: Don, if there is any reaction from 11 FMG to that suggestion or if you want to think about 12 it or if you want a moment. Other comments, Bennett &

13 Williams.

14 MS. ALLER: I just wanted to make sure that 15 we're not going to limit number 10 to only new ideas 16 and that I have been involved with some of the 17 sampling methodologies at particularly what relates to 18 what was done to the Washington Works site, and I 19 believe that there is some insufficiencies in those 20 whether or not they have been approved by two state 21 agencies, so I just wanted to make sure we're not 22 limiting  126 1 MR. AUER: No, there's not any attempt to 2 define the scope so much as I understand it to inform 3 as to what the industry's plans to do under their 4 Letter Of Intent and then to the extent that there are 5 other issues or needs that emerge from that, those 6 could be appropriately suited in the scope of the 7 Enforceable Consent Agreement.

8 MS. ALLER: Like I said, my only concern with 9 that is you keep saying other, if something is already 10 addressed and there might be some concerns about how 11 it would be inadequately addressed

12 MR. AUER: I am not attempting to  I mean I 13 am not contending that if there is a given approach 14 which is viewed as having issues that that's locked 15 up, that's not the case. I think what the industry is 16 suggesting is that they plan to run a monitoring 17 program which is based on that, and then it's for the 18 ECA process to consider whether for the purposes that 19 we're going at here in that the initial level of 20 understanding on these issues, whether that's okay or 21 if there are other elements that might be appropriate 22 for consideration, and these may go beyond the Letter 127 1 Of Intent.

2 MS. ALLER: That's fine.

3 MR. AUER: West Virginia Class Action.

4 MR. BILOTT: Rob Bilott. We would support with 5 the Environmental Working Group with respect to 6 getting an identification from both the FMG and the 7 TRP group of the various sites that would be among 8 those to consider. I think everybody needs to see the 9 list of exactly which are these manufacturing sites,

10 new sites, production sites, potential foam spill 11 sites, that needs to be produced up front, so that 12 there can be meaningful discussion about how to go 13 about doing the monitoring.

14 MR. AUER: You know one suggestion on that is 15 that if we decide to form this group to go off and 16 talk, the industry could present what it could at that 17 point, and this could be a topic that the CBI group 18 talk about specifically to see if there is a way to 19 form in this area in a way that doesn't present any 20 CBI issues, so I offer that for consideration by the 21 group.

22 DR. ZUCKERMAN: Hi, I'm Diana Zuckerman from 128 1 the National Center for Policy Research for Women and 2 Families. I have a question on clarification. It 3 wasn't clear to me that the focus was going to be only 4 on the new plants, but not on old plants, and I would 5 like clarify about that because obviously there are 6 old plants that have been manufacturing for a long 7 time that could have a different set of problems, even 8 if they're no longer in use.

9 MR. AUER: Thanks for that. While I think 10 about that for a minute, FMG?

11 MR. DUNCAN: The definition of terms is always 12 important. The place where new and old came into play 13 was in the manufacturing of APFO, the old plant which 14 has been shut down now which was operated by 3M and 15 there is a separate LOI that covers 3M's 16 responsibility and their legacy activities that are 17 associated with that. The new plant then is the one 18 that has been built by DuPont and that has a whole set 19 of already formal obligations associated with it. I 20 think to answer your question, both of them are 21 covered extensively, both the old and the new.

22 MS. SMYTHE: With regard to the monitoring 129 1 issues the TRP members would suggest that maybe that 2 technical group be a joint group between the  not 3 distinguished telomers and fluoropolymers, that it 4 should involve all the parties that might contribute 5 to the presence of PFOA both past and present parties,

6 and the difficulty to distinguish the source of PFOA 7 and all parties involved in that discussion group.

8 MR. AUER: Okay. Well, we now had a discussion 9 about the monitoring item suggestion being to form a 10 separate technical committee which would start with 11 the clear understanding of what's intended under the 12 LOIs and then discuss as appropriate any issues that 13 go beyond that. It's been suggested that this 14 technical group look at both fluoropolymers and 15 telomers, you know, as a combined group for purposes 16 of having that discussion.

17 The other point that was made here was the 18 proposal from TRP that all of the other issues, except 19 number 11, be moved into technical groups which for 20 the telomers, just so it's clear to everyone, this 21 would be the p chem and degradation and incineration,

22 so it would be the p chem properties, the 130 1 biodegradation and the incineration work, 2,3, and 8 2 in the table, they're recommending it would be 3 appropriate to go into the technical group.

4 Now, we did have the consideration point picked 5 up before, so that's consistent with what we had 6 worked out with the Fluoropolymer Manufacturing Group 7 and so the new elements in the proposals are in the 8 p chem properties and the biodegradation issue.

9 So I think the bottom  I think where we are 10 at this point, and I ask others to check, is that I 11 think that what this means is that for the telomer set 12 1 through 9 are moved into the technical groups,

13 number 10 which is monitoring is in this special group 14 on monitoring, and then the open issue is number 11 on 15 the fire fighting foams. Am I correct in that recap 16 of where we are, and we're trying to get the same 17 explanation for FMG as well.

18 MR. PENBERTHY: Item number 1 from the 19 fluoropolymer data needs is the fluoropolymer market 20 information, that would be in the CBI group as before,

21 then there is an interest in item number 2, item 22 number 7, item number 8, item number 9, and item 131 1 number 11 in the fluoropolymers group, and then there 2 would be a separate group for number 10, which is 3 environmental monitoring coupled with the telomers 4 effort in that area. Did I do that right? So that 5 would mean missing from the fluoropolymers data needs 6 would be the degradation pathways, the p chem 7 properties and then the PFOA contamination in 8 fluoropolymers and then fluoropolymer treated 9 articles, that's not covered yet so far  yeah, it is 10 in there  excuse me.

11 MR. AUER: I don't know how clear this is to 12 everybody, I think what we have at this point is a 13 situation where many of the issues that we started out 14 today, we've reached agreement to move those issues 15 into the technical workgroups. There are a limited 16 number of issues where we don't have that agreement,

17 and to test my memory, I think one is on the telomers 18 and the fire fighting foam situation, for the 19 fluoropolymers we have the degradation and p chem 20 properties on the fluoropolymers where FMG had 21 identified questions on that initially.

22 And then the remaining open items for FMG would 132 1 be the determination of PFOA contamination in 2 processed fluoropolymer and the presence of PFOA in 3 fluoropolymer products and articles, although there is 4 some testing on that last one that would be done under 5 the LOI. You know, I think that's really substantial 6 progress, any time you get things moving into the 7 technical groups I think there's a chance of 8 resolution.

9 And so what I would suggest at this point is 10 that testing the group on this, that we agree to 11 proceed in that way. We would schedule technical 12 groups, schedule a subsequent plenary and the items 13 that would be considered in the plenary would be the 14 items which we have not moved into the technical 15 groups, so it would provide an opportunity for 16 interested parties to discuss issues or needs or 17 technical problems, or whatever the case might be with 18 those open areas of the Framework that EPA has 19 proposed, and then to decide what happens at that 20 point.

21 There may be issues where we know we're not 22 going to get consensus in which case we would go off 133 1 and do what we had to do would or there could be other 2 areas that could be right for moving into technical 3 groups, or we may need additional plenary discussions 4 on those items.

5 So that's, I think where we are, set of 6 activities moving into workgroups, you've got a 7 fluoropolymer group dealing with those issues as 8 appropriately, you got a telomer group dealing with 9 those issues, we got a CBI group dealing specifically 10 with that, and we have a monitoring group dealing with 11 those issues, so those are the four technical 12 workgroups that we've got, we have another set of 13 issues, ones I've just gone through which would be 14 returned to the plenary for additional discussion 15 among a larger group at some point in the future. So 16 if I could test amongst the interested parties whether 17 there's agreement on that principle to move in that 18 direction? I see a lot of nodding, okay.

19 So that's the way that's the way that we'll 20 proceed. I hope that's sufficiently clear for 21 everyone. We will summarize this hopefully with great 22 clarity in the near future to make sure that we 134 1 haven't misunderstood anything. It would be useful 2 for interested parties to think about whether they 3 would like to be participants in the monitoring group,

4 as well as any interested parties who wish to further 5 associate or additional groups to associate themselves 6 with the CBI, the FMG, or it telomer groups, as laid 7 out on the flip chart.

8 The other thing, what I am going to do at this 9 point is we'll shift into the public comment period 10 for 30 minutes and then I would like to come back and 11 close, where we try to work out the schedule for when 12 we're going to attempt to have the first of the 13 technical discussions and then the time frame for the 14 next plenary, okay, so think about that.

15 And if in addition there are any points that I 16 have lost along the way that have been raised by 17 interested parties, after the public comment period 18 that would be the chance for us to pick up any missed 19 items and make sure they are carried forward with us.

20 So we are now into the public comment period.

21 We are going to start with Della Tennant who had 22 started her intervention earlier and asked her to 135 1 defer to this point.

2 MS. TENNANT: By now everybody knows I am Della 3 Tennant and I live at 15 Mansion Boulevard in 4 Parkersburg, West Virginia. Along with my husband we 5 own Tennant Rentals, the address there is 3117 6 Parkersurg, West Virginia, Middle Ohio Valley Teflon 7 contaminated area. I come to you today as a very 8 concerned, very concerned mother, grandmother, sister,

9 and landlord, neighbor and friend of the Middle Ohio 10 Valley. We own property next to the DuPont landfill 11 located Route 68 south and our property is located 12 around 15 hundred feet from the DuPont landfill.

13 Although I know we are not here today to 14 discuss the landfill, but we are here today to discuss 15 the PFOA, or as I say it, the Teflon related chemicals 16 and the Teflon contamination in the Middle Ohio 17 Valley. We owned 68 acres of that property that was 18 sold to DuPont and it was not sold for any unregulated 19 or regulated chemical dumping in any way. We sued 20 DuPont a few years back. Going up against DuPont was 21 hard to do and especially for our family, we are awful 22 small people, and they are an awful big business, but 136 1 it was something that we needed to do.

2 Our family has been sick, we have lost several 3 heads of cattle, so there was a need there that needed 4 to be done. Jim's brothers, Jack and Earl are both 5 sick and their families are all sick now. Earl is 6 having problems with his lung respiratory and Jack is 7 having problems with his respiratory and also heart 8 problems. His mother got sick very sudden, now this 9 was before the lawsuit, but it was during it time that 10 we had sold our property to DuPont and they began 11 dumping these chemicals. I took care of her. I can 12 relate to the suffering that she suffered and I also 13 helped take care of the cattle, and I feel like it is 14 related.

15 And as I mentioned before, during this lawsuit 16 we was represented by two of the most outstanding law 17 firms there is in the United States and two of the 18 best lawyers that any of God's children could ever 19 hope to have, and that would be Rob Bilott and 20 ( inaudible) and I think they should be commended for 21 the job that they did, because they did a fantastic 22 job. They discovered during the time of the lawsuit 137 1 that C8 was in our water.

2 In March I put an article on the medical chart 3 and the Middle Ohio Valley Medical Directory opposing 4 the landfill that was coming up, the landfill permit 5 that was coming up for renewal or came up for renewal 6 in April 2002. This article came out in the paper on 7 March the 31st with over 50,000 copies printed.

8 During that same time the EPA had announced on 9 the ( inaudible) that they would like to have 10 interested parties to send in their comments to the 11 EPA in preparing for a June hearing with anybody that 12 was interested in what problems with the C8 in their 13 water that had contaminated their water. I talked to 14 Kris and she gave me all the information, so I took 15 the information that she gave me and posted it on my 16 website thinking that I could get more news out to 17 people knowing that there was 50,000 copies of the 18 medical directory that had just been printed.

19 When I put that on the website I got a call in 20 a couple of day s that my Post Office box had been 21 blocked. This lady called me and said that she had 22 sent a letter and was asking me if I knew who might 138 1 have put that article in the newspaper about the 2 landfill and opposing the landfill permit. Of course 3 there was a big chance I knew the answer to that 4 question. I told her I would call her back, so I 5 called the Post Office to see what the problem was and 6 I had a block put on our Post Office box with all my 7 mail returned to sender, so I called her back and I 8 picked up the letter. This really upset me. I was 9 infuriated. I don't know why I cannot have a Post 10 Office box.

11 I opened the Post Office box for the petition 12 only. The petition is a follow up from the lawsuit 13 that we had with DuPont with the problems that we're 14 having in the Middle Ohio Valley. I began going 15 door to door talking to people, we stopped at every 16 house and we told the people about the landfill permit 17 coming up for renewal and asked them to give it a 18 chance if they would like to oppose this that they 19 were more than welcome to sign this petition, at 20 during which time I told them about the EPA asking 21 people to send letters and comments to them with their 22 concerns. 139 1 I began receiving letters from people, people 2 telling me of the problems that they're having with 3 their health, and at this time I would like to thank 4 whoever that was that made the mistake of and put a 5 block on my Post Office box because if that had not 6 been, I would not be going door to door. I had no 7 intentions of going door to door.

8 These people were telling me that they are very 9 sick. They are on oxygen respirators, heart problems,

10 thyroid, gall bladder, liver problems, cancer,

11 problems with breaking out in rashes and breaking out 12 in hives whenever they take a shower or bath, scared 13 to let their children play in a bathtub, scared to 14 give their child a drink from the kitchen faucet. Our 15 tenants who live close to the DuPont landfill have 16 been sick with respiratory problems, congestive heart 17 failure, and also have been diagnosed with cancer.

18 And that the very reason that ( inaudible) is not here 19 with us today because she is at the Cleveland Clinic 20 for more tests, she has colon cancer.

21 MR. AUER: Excuse me. We have outlined three 22 minutes for the public statements. 140 1 MS. TENNANT: I have two more paragraphs.

2 MR. AUER: Okay. And then if you would care to 3 submit something in writing you could do that as well.

4 MS. TENNANT: Thank you. People with small 5 children with their teeth decaying, so that they have 6 to have all their teeth pulled to prevent infections,

7 kids missing school with flu like symptoms, kids being 8 hospitalized with acid reflux and the people in the 9 churches that are sick, losing weight and not knowing 10 what the answer is.

11 People in the Middle Ohio Valley are very 12 concerned about all of the contamination from Teflon.

13 They are afraid. People want to speak up and say 14 something about the chemical but, they are afraid they 15 will lose their jobs. People cannot afford to lost 16 their jobs there is too much sickness, they need their 17 insurance, and they are afraid if they do speak up 18 they will lose their jobs.

19 I feel that DuPont is responsible for the 20 Teflon contaminated area around the Lubeck water and 21 Little Hocking water. I have family in the Little 22 Hocking area and I have family in the Lubeck area. 141 1 They are responsible for the contamination in the 2 Middle Ohio Valley, they are responsible for the 3 contamination in the Ohio River. People in the Middle 4 Ohio Valley are afraid of what this has done to their 5 family and they are afraid of what the chemicals have 6 done to their families and their friends. Please stop 7 this pollution by giving us clean air to breathe and 8 clean water to drink.

9 Thank you and may God bless America.

10 DR. ZUCKERMAN: I'm Dr. Diana Zuckerman from 11 the National Center for Policy Research for Women and 12 Families in Washington and our focus is on taking 13 research, complicated scientific research information 14 and trying to translate it into something resembling 15 useable, understandable information for consumers, for 16 policy makers, and opinion leaders, and for the media.

17 In this case that's both hard and easy to do,

18 there's not much research on this issue and so it's 19 hart to know how to translate that into useable 20 information when we're lacking so much information.

21 My training is in epidemiology, so when I hear a story 22 like yours. 142 1 First, I want to thank you because it is very 2 hard to come here and to tell a personal story, and it 3 is particularly moving to me because I know that there 4 are a lot of other stories like that for every person 5 who has the guts and resources to come. As an 6 epidemiologist I know that to look at the patterns 7 from those you don't know what to do with the 8 anecdotal information there's a lot of it.

9 There are a long range of illnesses that you 10 mentioned and it is hard to know what might be 11 relevant, but that doesn't mean you shouldn't look and 12 look really carefully. These are complicated issues,

13 we've heard that from the industry and they are very 14 complicated issues and consumer groups and individual 15 consumers are at a real disadvantage when it comes to 16 technical workgroups, how do we have our voices heard,

17 how do we help scrutinize industry developed protocols 18 to make sure that those protocols really do look at 19 the issues that need to be looked at in the way that 20 we'll get the most truthful accurate information.

21 So all I can say to you is to beseech you to do 22 whatever you can to make sure there is that balance 143 1 that consumer needs and interests are being 2 represented, that there is scrutiny on all sides of 3 all of issues that you are looking at and I really do 4 thank you for the opportunity be here and to see what 5 is going on.

6 MR. AUER: Thank you for that. One comment I 7 would offer in that regard is I think that this 8 process by virtue of this public component, I think 9 provides a real opportunity for interested parties be 10 they technically qualified or a public interest group 11 or community group or whatever the case might be to 12 participate and understand, and I think that one of 13 the virtues of having the technical groups go off is 14 they can go off and do their work where hopefully you 15 have the appropriate balance of expertise and 16 interested parties and whatnot, and then it ultimately 17 comes to the plenary where the work of the technical 18 group is ultimately accepted or modified or sent back 19 for the work or whatever the case might be, so we 20 believe very much that the public component is a 21 critical element in this process and look forward to 22 continued working with the all of the members of the 144 1 interested parties and then listening to the comments 2 from the public as we proceed in our work.

3 Does that take care of everyone among the 4 public speakers?

5 MS. TENNANT: Thank you for giving me a chance 6 to speak.

7 MR. AUER: Thank you. We appreciate your 8 comments.

9 One second, and then we're going to talk about 10 the schedule. We've listed on the flip chart the 11 monitoring group and we have also identified those 12 areas from among the EPA Framework that will be coming 13 back to the plenary, so if there is any comment on any 14 area there, please bring it forward now. EWG, do you 15 have a comment? And one of the open items which maybe 16 we should talk about now is who amongst the interested 17 parties would like to join, I guess, the monitoring 18 group is a new group and then beyond that to the 19 extent moving any of the other issues into the telomer 20 or fluoropolymer group, causes someone to want to be 21 involved in that technical group, please identify.

22 And EWG indicated that they would wish to 145 1 participate in the monitoring group and Rich Purdy as 2 well in the monitoring group, and we have Little 3 Hocking Water Association, West Virginia Class Action 4 Plaintiffs, Bennett & Williams. And I don't recall 5 the name of your organization

6 DR. ZUCKERMAN: National Center for Policy 7 Research for Women and Families.

8 MR. AUER: And to the extent that there are 9 others who wish to, amongst the interested parties 10 participate, please identify yourself. The next item 11 is schedule when we might reconvene. What I would 12 propose for the group is that we consider scheduling a 13 plenary during the week of July 7th, we can be 14 somewhat flexible as to the day during the week. I 15 would propose that we do not do it on a Friday since I 16 think that poses problems for people especially when 17 someone is coming from out of town, but would try to 18 find a date during that week that would be appropriate 19 for the next plenary, we would communicate that out to 20 the interested parties, and then for the various 21 workgroups I would like to get that work going pretty 22 quickly, so I am going to suggest dates that might 146 1 push people. I ask you to think about it, if it's a 2 problem, let's talk about it, but I would propose that 3 those the workgroups and I think it is useful for all 4 four to have an initial discussion.

5 I would like to propose that the workgroups 6 first convene during the period of the week of the 7 16th of June through the week of the 23rd of June, so 8 that's a two week period. Given the overlap in the 9 groups, there may be value in thinking about the ways 10 we can run the meetings on sequential dates or 11 whatever the case might be, but I would propose for 12 the interested parties that we look at holding these 13 first discussions during that two week period with 14 those groups as appropriate reporting back to the 15 plenary here. One suggestion is that to the extent 16 that we schedule the plenary on either the 9th or the 17 10th that could be open about 8 if there is value in 18 certain of the workgroups getting together to talk 19 about things to see if they can advance things before 20 reporting things into the plenary on either the 9th or 21 the 10th, so that's our proposal for how we go forward 22 regarding dates, so if there's any reaction to that? 147 1 MR. SPEAKER: ( Inaudible)

2 MR. AUER: I suspect that's a more general 3 sentiment. I take it I have the agreement of the 4 group to work within the dates as I've outlined them 5 to set up the plenary and what we'll do with the 6 workgroups is we will work with those interested 7 parties who have identified themselves and then try to 8 find dates that can be most easily accommodated from 9 amongst those groups.

10 The last items  is there a comment?

11 MS. SPEAKER: ( Inaudible)

12 MR. AUER: I don't know that there's any date 13 in the future that get together on, but I appreciate 14 the point. If there is a more general issue with that 15 week if, I can get a read from the group, I suggested 16 the 9th and 10th, but there could be people taking the 17 whole week. I would propose that we keep that week 18 recognizing that we will lose some people, but that we 19 not do anything at least on the Monday, so I think 20 we're talking about the technical discussions on 21 Tuesday the 8th with the plenary, I think likely on 22 the 9th to provide for a meet ing opportunity on two 148 1 dates the other alternative the is to go to Wednesday,

2 Thursday, technical group on Wednesday, the plenary on 3 Thursday, if people would like an extra day for 4 vacation. Is that all right? Why don't we go with 5 that, technical discussions on Wednesday the 8th,

6 plenary on Thursday the 9th  I am sorry, I am sorry 7  all right. Let's have it on Wednesday the 9th and 8 Thursday the 10th. Okay, the workgroups on the 9th 9 and the plenary on the 10th, okay.

10 Are there any loose ends that we need to be 11 reminded of and carry into our further discussions?

12 MR. OSHIDA: Can we make sure, since we're 13 going to do most of the communications by email, that 14 we have everybody's email address on the registration,

15 if you haven't done that can you please either go back 16 and add it to your list or send Mary something and so 17 that we then have your address. Thank you very much.

18 MR. AUER: Okay. Are there any other points 19 that any of the interested parties would wish to make 20 at this juncture. It is about ten of five, I am sure 21 people want to get going if they can.

22 Well, thank you. I think we have made 149 1 wonderful progress and I thank you for all your help 2 and in moving towards the understandings and 3 agreements that we have so far, and I look forward to 4 additional discussions.

5 6 ( Whereupon, at 4: 50 p. m. the meeting adjourned.)

7  oo0oo

8 9 10 11 12 13 14 15 16 17 18 150 CERTIFICATE OF STENOTYPE REPORTER I, Monica L. Knight, Stenotype Reporter, do hereby certify that the foregoing proceedings were reported by me in stenotypy, transcribed under my direction and are a verbatim record of the proceedings had.

_______________________________

MONICA L. KNIGHT


[Federal Register: March 19, 2007 (Volume 72, Number 52)]
[Notices]
[Page 12794]
[DOCID:fr19mr07-58]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER07-169-000; Docket No. ER07-170-000]

Ameren Energy Marketing Company, Ameren Energy, Inc.; Notice
Allowing Post-Technical Conference Comments

March 13, 2007.
    Pursuant to the December 26, 2006 order in this proceeding, Ameren
Energy Marketing Co., 117 FERC ] 61,334 (2006), a staff technical
conference was held on Tuesday, March 13, 2006 at the offices of the
Federal Energy Regulatory Commission. The technical conference
addressed issues related to potential affiliate abuse in the sale of
ancillary services among Ameren affiliates.
    Take notice that the Commission will accept post-technical
conference comments. Initial comments are due no later than 5 p.m.
Eastern Time on April 3, 2007. Reply comments are due no later than 5
p.m. Eastern Time on April 17, 2007.
    For further information please contact Zeny Magos at<PHONE_NUMBER>
or e-mail<EMAIL_ADDRESS>
Philis J. Posey,
Acting Secretary.
[FR Doc. E7-4987 Filed 3-16-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 73 (Tuesday, April 16, 2013)]
[Proposed Rules]
[Page 22501]
[FR Doc No: 2013-08840]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 81

[EPA-R09-OAR-2013-0104; FRL-9802-5]

Designation of Areas for Air Quality Planning Purposes; State of
Nevada; Total Suspended Particulate

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to delete certain area designations for total
suspended particulate within the State of Nevada because the
designations are no longer necessary. These designations relate to the
attainment or unclassifiable areas for total suspended particulate in
Clark County as well as the following nonattainment areas for total
suspended particulate elsewhere within the State of Nevada: Carson
Desert, Winnemucca Segment, Lower Reese Valley, Fernley Area, Mason
Valley, and Clovers Area. EPA is proposing this action under the Clean
Air Act.

DATES: Written comments must be received on or before May 16, 2013.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2013-0104, by one of the following methods:
    1. Federal eRulemaking Portal: www.regulations.gov: Follow the on-
line instructions for submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Mail or deliver: Karina O'Connor (AIR-2), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or email.
www.regulations.gov is an ``anonymous access'' system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send email directly to EPA, your email
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at EPA Region
IX, 75 Hawthorne Street, San Francisco, California. While all documents
in the docket are listed in the index, some information may be publicly
available only at the hard copy location (e.g., copyrighted material),
and some may not be publicly available in either location (e.g., CBI).
To inspect the hard copy materials, please schedule an appointment
during normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section below.

FOR FURTHER INFORMATION CONTACT: Karina O'Connor, EPA Region IX, (775)
434-8176<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This proposal relates to deletions of
certain area designations for total suspended particulate (TSP) in the
State of Nevada. Specifically, EPA proposes to delete the attainment or
unclassifiable areas for total suspended particulate in Clark County as
well as the following nonattainment areas for total suspended
particulate elsewhere within the State of Nevada: Carson Desert,
Winnemucca Segment, Lower Reese Valley, Fernley Area, Mason Valley, and
Clovers Area. EPA is proposing this action under section 107(d)(4)(B)
of the Clean Air Act based on the Agency's determination that the TSP
designations for these areas are no longer necessary.
    In the Rules and Regulations section of this Federal Register, EPA
is deleting these area designations in a direct final rule without
prior proposal because the Agency views this as a non-controversial
action and anticipates no adverse comments. A detailed rationale for
the deletions is set forth in the preamble to the direct final rule. If
EPA receives no adverse comments, EPA will not take further action on
this proposed rule. If EPA receives adverse comments, EPA will publish
a timely withdrawal of the direct final rule in the Federal Register to
notify the public that the direct final rule will not take effect. EPA
will address all public comments in a subsequent final rule based on
this proposed rule. EPA will not institute a second comment period on
this action. Any parties interested in commenting must do so at this
time. Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. For
additional information, please see the direct final rule of the same
title which is located in the Rules and Regulations section of this
Federal Register.

    Dated: April 1, 2013.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2013-08840 Filed 4-15-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: October 22, 2010 (Volume 75, Number 204)]
[Rules and Regulations]
[Page 65226-65227]
[DOCID:fr22oc10-7]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0685; Airspace Docket No. 10-ASO-27]

Establishment of Class E Airspace; Bamberg, SC

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action establishes Class E Airspace at Bamberg, SC, to
accommodate the additional airspace needed for the Standard Instrument
Approach Procedures (SIAPs) developed for Bamberg County Airport.

DATES: Effective 0901 UTC, January 13, 2011. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Melinda Giddens, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On August 27, 2010, the FAA published in the Federal Register a
notice of proposed rulemaking to establish Class E airspace at Bamberg,
SC (75 FR 52654) Docket No. FAA-2010-0685. Interested persons are
invited to participate in this rulemaking effort by submitting written
comments on the proposal to the FAA. No comments were received. Class E
airspace designations are published in paragraph 6005 of FAA Order
7400.9U dated August 18, 2010, and effective September 15, 2010, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designations listed in this document will be published subsequently in
the Order.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 establishes the Class E airspace extending upward from 700 feet
above the surface at Bamberg, SC, to provide controlled airspace
required to support the SIAPs developed for Bamberg County Airport.
This action enhances the safety and airspace management of Instrument
Flight Rules (IFR) operations at the airport.

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore, (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart I, section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes Class E airspace at Bamberg, SC.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND CLASS E AIRSPACE
AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9U, Airspace Designations and Reporting
Points, dated August 18, 2010, effective September 15, 2010, is amended
as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ASO SC E5 Bamberg, SC [NEW]

Bamberg County Airport, SC
    (Lat. 33[deg]18'16'' N., long. 81[deg]06'30'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.3-mile radius of the Bamberg County Airport.

    Issued in College Park, Georgia, on October 12, 2010.
Mark D. Ward,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2010-26686 Filed 10-21-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: June 5, 2007 (Volume 72, Number 107)]
[Notices]
[Page 31069-31070]
[DOCID:fr05jn07-43]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2007-0243; FRL-8321-5]

Board of Scientific Counselors, Ecological Research Program Mid-
Cycle Review Meeting--Spring 2007

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meetings.

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

SUMMARY: Pursuant to the Federal Advisory Committee Act, Public Law 92-
463, the Environmental Protection Agency, Office of Research and
Development (ORD), gives notice of one meeting of the Board of
Scientific Counselors (BOSC) Eco Mid-Cycle Subcommittee.

DATES: The meeting (a teleconference call) will be held on Thursday,
June 28, 2007, from 10 a.m. to 12 p.m. All times noted are eastern
time. The meeting may adjourn early if all business is finished.
Requests for the draft agenda or for making oral presentations at the
meeting will be accepted up to 1 business day before the meeting.

ADDRESSES: Participation in the conference call will be by
teleconference only--a meeting room will not be used. Members of the
public may obtain the call-in number and access code for the call from
Heather Drumm, whose contact information is listed under the FOR
FURTHER INFORMATION CONTACT section of this notice. Submit your
comments, identified by Docket ID No. EPA-HQ-ORD-2007-0243, by one of
the following methods:

     http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
     E-mail: Send comments by electronic mail (e-mail) to:
<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-ORD-2007-0243.

     Fax: Fax comments to:<PHONE_NUMBER>, Attention Docket ID
No. EPA-HQ-ORD-2007-0243.
     Mail: Send comments by mail to: Board of Scientific
Counselors, Ecological Mid-Cycle Subcommittee Meeting--Spring 2007
Docket, Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC
20460, Attention Docket ID No. EPA-HQ-ORD-2007-0243.
     Hand Delivery or Courier. Deliver comments to: EPA Docket
Center (EPA/DC), Room B102, EPA West Building, 1301 Constitution
Avenue, NW., Washington, DC, Attention Docket ID No. EPA-HQ-ORD-2007-
0243. Note: this is not a mailing address. Such deliveries are only
accepted during the docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2007-0243. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-mail.

The http://www.regulations.gov Web site is an ``anonymous access'' system,

which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://www.regulations.gov,

your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

    Docket: All documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Board of Scientific

Counselors, Ecological Mid-Cycle Subcommittee Meeting--Spring 2007
Docket, EPA/DC, EPA West, Room B102, 1301 Constitution Ave., NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the ORD Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: The Designated Federal Officer via
mail at: Heather Drumm, Mail Drop 8104-R, Office of Science Policy,
Office of Research and Development, Environmental Protection Agency,
1300 Pennsylvania Ave., NW., Washington, DC 20460; via phone/voice mail
at:<PHONE_NUMBER>; via fax at:<PHONE_NUMBER>; or via e-mail at:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

General Information

    Any member of the public interested in receiving a draft BOSC
agenda or making a presentation at the meeting may contact Heather
Drumm, the Designated Federal Officer, via any of the contact methods
listed in the FOR FURTHER INFORMATION CONTACT section above. In
general, each individual making an oral presentation will be limited to
a total of three minutes.
    Proposed agenda items for the meeting include, but are not limited
to finalizing the subcommittee's draft report and discussing the rating
component for the Eco research program. The meeting is open to the
public.
    Information on Services for Individuals with Disabilities: For
information on access or services for individuals with disabilities,
please contact Heather Drumm at<PHONE_NUMBER> or
<EMAIL_ADDRESS>To request accommodation of a disability, please

contact Heather Drumm, preferably at least 10 days prior to the
meeting, to give EPA as much time as possible to process your request.

    Dated: May 31, 2007.
Mary Ellen Radzikowski,
Acting Director, Office of Science Policy.
[FR Doc. E7-10769 Filed 6-4-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 25 (Friday, February 6, 2015)]
[Rules and Regulations]
[Page 6652]
[FR Doc No: 2015-02425]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

17 CFR Parts 229, 230, and 232

[Release Nos. 33-9720; 34-74194; File No. S7-08-10]

Asset-Backed Securities Disclosure and Registration

AGENCY: Securities and Exchange Commission.

ACTION: Technical amendment.

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

SUMMARY: This release makes technical corrections to rules that were
published in the Federal Register on September 24, 2014. The Commission
adopted revisions to Regulation AB and other rules governing the
offering process, disclosure, and reporting for asset-backed
securities. These technical amendments are being published to reinstate
language that was inadvertently removed and make other technical
corrections.

DATES: Effective February 6, 2015.

FOR FURTHER INFORMATION CONTACT: Kayla M. Florio, Attorney-Advisor, at
(202) 551-3850; Division of Corporation Finance, Securities and
Exchange Commission, 100 F Street NE., Washington, DC 20549-3628.

SUPPLEMENTARY INFORMATION: This release technical amendments to Sec.
229.1100, Sec.  230.190, and Sec.  232.201 that were published in the
Federal Register on September 24, 2014 (79 FR 57184).

List of Subjects

17 CFR Part 230

    Advertising, Reporting and recordkeeping requirements, Securities.

17 CFR Parts 229 and 232

    Reporting and recordkeeping requirements, Securities.

Text of Amendments

    For the reasons set out in the preamble, Title 17, Chapter II, of
the Code of Federal Regulations is amended as follows:

PART 229--STANDARD INSTRUCTIONS FOR FILING FORMS UNDER SECURITIES
ACT OF 1933, SECURITIES EXCHANGE ACT OF 1934 AND ENERGY POLICY AND
CONSERVATION ACT OF 1975--REGULATION S-K

0
1. The authority citation for part 229 continues to read as follows:

    Authority:  15 U.S.C. 77e, 77f, 77g, 77h, 77j, 77k, 77s, 77z-2,
77z-3, 77aa(25), 77aa(26), 77ddd, 77eee, 77ggg, 77hhh, 777iii,
77jjj, 77nnn, 77sss, 78c, 78i, 78j, 78j-3,78l, 78m, 78n, 78n-1, 78o,
78u-5, 78w, 78ll, 78mm, 80a-8, 80a-9, 80a-20, 80a-29, 80a-30, 80a-
31(c), 80a-37, 80a-38(a), 80a-39, 80b-11, and 7201 et seq.; and 18
U.S.C. 1350, unless otherwise noted.
* * * * *

Sec.  229.1100  [Amended]

0
2. Amend Sec.  229.1100 in paragraph (f) by removing the reference
``(Sec. Sec.  229.1100 through 229.1124)'' and adding in its place
``(Sec. Sec.  229.1100 through 229.1125)''.

PART 230--GENERAL RULES AND REGULATIONS, SECURITIES ACT OF 1933

0
3. The authority citation for part 230 continues to read, in part, as
follows:

    Authority:  15 U.S.C. 77b, 77b note, 77c, 77d, 77d note, 77f,
77g, 77h, 77j, 77r, 77s, 77z-3, 77sss, 78c, 78d, 78j, 78l, 78m, 78n,
78o, 78o-7 note, 78t, 78w, 78ll(d), 78mm, 80a-8, 80a-24, 80a-28,
80a-29, 80a-30, and 80a-37, and Pub. L. 112-106, sec. 201(a), 126
Stat. 313 (2012), unless otherwise noted.
* * * * *

Sec.  230.190  [Amended]

0
4. Amend Sec.  230.190 in paragraph (b)(5) by adding ``and'' after
``securities;''.

PART 232--REGULATION S-T--GENERAL RULES AND REGULATIONS FOR
ELECTRONIC FILINGS

0
5. The authority citation for part 232 continues to read, in part, as
follows:

    Authority:  15 U.S.C. 77f, 77g, 77h, 77j, 77s(a), 77z-3,
77sss(a), 78c(b), 78l, 78m, 78n, 78o(d), 78w(a), 78ll, 80a-6(c),
80a-8, 80a-29, 80a-30, 80a-37, and 7201 et seq.; and 18 U.S.C. 1350.
* * * * *

Sec.  232.201  [Amended]

0
6. Amend Sec.  232.201 in paragraph (a) introductory text by adding
``an application for an order under any section of the Investment
Company Act (15 U.S.C. 80a-1 et seq.),'' after ``a Form D (239.500 of
this chapter),''.

    Dated: February 3, 2015.
Brent J. Fields,
Secretary.
[FR Doc. 2015-02425 Filed 2-5-15; 8:45 am]
BILLING CODE 8011-01-P


 MEMORANDUM

DATE:	January 3, 2012 SUBJECT:	Environmental Justice Review: Secondary Aluminum RTR FROM:	Rochelle Boyd, US EPA TO:		Secondary Aluminum RTR Docket

1.0	INTRODUCTION Executive Order 12898 (59 FR 7629, February 16, 1994) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies and activities on minority populations and low income populations in the United States. 2.0 DEMOGRAPHICS The EPA has determined that this proposed rule will not have disproportionately high and adverse human health or environmental effects on minority, low income or indigenous populations because it increases the level of environmental protection for all affected populations without having any disproportionately high and adverse human health or environmental effects on any population, including any minority, low income or indigenous populations.

These proposed standards may improve public health and welfare, now and in the future, by limiting HAP emissions that may contribute to adverse environmental and human health impacts. The control of HAP emissions associated with the rule is expected to benefit all populations living near the sources affected by this rule.

Additionally, the agency has reviewed this rule to determine if there is an overrepresentation of minority, low income or indigenous populations near the sources such that they may currently face disproportionate risks from pollutants that could be mitigated by this rulemaking. This analysis only gives some indication of the prevalence of sub-populations that may be exposed to HAP pollution from the sources affected by this rulemaking; it does not identify the demographic characteristics of the most highly affected individuals or communities, nor does it quantify the level of risk faced by those individuals or communities.

The major source demographic analysis shows that while most demographic categories are below or within 10 percent of their corresponding national averages, the African American percentage within 3 miles of any source affected by this rulemaking exceeds the national average by 3 percentage points (16 percent versus 13 percent), or +23 percent. The area source sector-wide analysis of near source populations reveals that several demographic categories exceed 10 percent of their corresponding national averages: Minority by +16 percentage points (44% vs. 28%), or +57%; Hispanic or Latino by +17 percentage points (34% vs. 17%), or +100%; Without a High School Diploma by +6 percentage points (16% vs. 10%), or +60%, and; Below National Poverty Line: +7 percentage points (21% vs. 14%), or +50%.

        Table 2.1 Summary of Demographic Data Analysis (Major Sources)

         Table 2.2 Summary of Demographic Data Analysis (Area Sources)

The analysis of demographic data used proximity-to-a-source as a surrogate for exposure to identify those populations considered to be living near affected sources, such that they have notable exposures to emissions from these sources. The demographic data for this analysis were extracted from the 2000 census data, which were provided to the EPA by the United States Census Bureau. Distributions by race are based on demographic information at the census block level, and all other demographic groups are based on the extrapolation of census block group level data to the census block level. The socio-demographic parameters used in the analysis included the following categories: Racial (White, African American, Native American, Other or Multiracial and All Other Races); Ethnicity (Hispanic); and Other (Number of people below the poverty line, Number of people with ages between 0 and 18, Number of people with ages greater than or equal to 65, Number of people over age 25 without a high school diploma).

In determining the aggregate demographic makeup of the communities near affected sources, the EPA focused on those census blocks within 3 miles of affected sources and determined the demographic composition (e.g., race, income, etc.) of these census blocks and compared them to the corresponding compositions nationally. The radius of 3 miles (or approximately 5 km) is consistent with other demographic analyses focused on areas around potential sources,,, however, not necessarily associated with the distance at which health risks are seen. To the extent that any minority, low income or indigenous subpopulation is disproportionately impacted by the emissions as a result of the proximity of their homes to these sources, that subpopulation also benefits from the emission reductions called for by this rule.


[Federal Register: August 26, 2009 (Volume 74, Number 164)]
[Rules and Regulations]
[Page 43029-43030]
[DOCID:fr26au09-1]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-1099; Airspace Docket No. 08-AWP-10]

Modification of Class E Airspace; Lake Havasu, AZ

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action will modify Class E airspace at Lake Havasu, AZ.
Additional controlled airspace is necessary to accommodate aircraft
using a new Area Navigation (RNAV) Global Positioning System (GPS)
Standard Instrument Approach Procedure (SIAP) at Lake Havasu City
Airport, Lake Havasu, AZ. This will improve the safety of Instrument
Flight Rules (IFR) aircraft executing the new RNAV GPS SIAP at Lake
Havasu City Airport, Lake Havasu, AZ. This also makes a minor change in
the airport description. It changes the 2.2-mile radius of Chemehuevi
Valley Airport to a 2.3-mile radius.

DATES: Effective Date: 0901 UTC, December 17, 2009. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue, SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On June 24, 2009, the FAA published in the Federal Register a
notice of proposed rulemaking to establish additional controlled
airspace at Lake Havasu, AZ (74 FR 30025). Interested parties were
invited to participate in this rulemaking effort by submitting written
comments on the proposal to the FAA. No comments were received.
Subsequent to publication of the NPRM, the FAA found an error in the
airport description for the excluded airspace. This action corrects
that error.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.9S signed October 3, 2008, and effective October 31,
2008, which is incorporated by reference in 14 CFR part 71.1. The Class
E airspace designations listed in this document will be published
subsequently in that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by amending the Class E airspace at Lake Havasu, AZ. Additional
controlled airspace is necessary to accommodate IFR aircraft executing
a new RNAV (GPS) approach procedure at Lake Havasu City Airport, Lake
Havasu, AZ. This action also corrects the 2.2-mile radius exclusion to
2.3 miles.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act. The FAA's authority to
issue rules regarding aviation safety is found in Title 49 of the U.S.
Code. Subtitle 1, Section 106 discusses the authority of the FAA
Administrator. Subtitle VII, Aviation Programs, describes in more
detail the scope of the agency's authority. This rulemaking is
promulgated under the authority described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that section, the FAA is charged with
prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it establishes
additional controlled airspace at Lake Havasu City Airport, Lake
Havasu, AZ.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9S, Airspace Designations and
Reporting Points, signed October 3, 2008, and effective October 31,
2008 is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AWP AZ E5 Lake Havasu, AZ [Modified]

Lake Havasu City, AZ
    (Lat. 34[deg]34'16'' N., long. 114[deg]21'30'' W.)
Chemehuevi Valley Airport, CA
    (Lat. 34[deg]31'44'' N., long. 114[deg]25'56'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.7-mile radius of Lake Havasu City Airport and within 1
mile each side of the Lake Havasu City Airport 150[deg] bearing
extending from the 6.7-mile radius to 13 miles southeast of the Lake
Havasu City Airport, excluding that airspace with a 2.3-mile radius
of Chemehuevi Valley Airport. That airspace extending upward from
1,200 feet above the surface bounded by a line beginning at lat.
34[deg]42'47'' N., long. 114[deg]29'37'' W.; to lat. 34[deg]42'47''
N., long. 114[deg]12'06'' W.; to lat. 34[deg]23'00'' N., long.
114[deg]12'06'' W.; to lat. 34[deg]17'19'' N., long. 114[deg]32'12''
W.; thence to the point of beginning.
* * * * *

    Issued in Seattle, Washington, on August 14, 2009.
H. Steve Karnes,
Team Manager, Operations Support Group, Western Service Center.
[FR Doc. E9-20278 Filed 8-25-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 83 (Tuesday, April 30, 2013)]
[Proposed Rules]
[Pages 25233-25234]
[FR Doc No: 2013-10182]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2012-1283; Airspace Docket No. 12-AGL-15]

Proposed Establishment of Class E Airspace; Mahnomen, MN

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class E airspace at
Mahnomen, MN. Controlled airspace is necessary to accommodate new
Standard Instrument Approach Procedures (SIAP) at Mahnomen County
Airport. The FAA is taking this action to enhance the safety and
management of Instrument Flight Rules (IFR) operations for SIAPs at the
airport.

DATES: Comments must be received on or before June 14, 2013.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You
must identify the docket number FAA-2012-1283/Airspace Docket No. 12-
AGL-15, at the beginning of your comments. You may also submit comments
through the Internet at http://www.regulations.gov. You may review the
public docket containing the proposal, any comments received, and any
final disposition in person in the Dockets Office between 9:00 a.m. and
5:00 p.m., Monday through Friday, except Federal holidays. The Docket
Office (telephone 1-800-647-5527), is on the ground floor of the
building at the above address.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone: (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2012-1283/
Airspace Docket No. 12-AGL-15.'' The postcard will be date/time stamped
and returned to the commenter.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Central Service Center, 2601
Meacham Blvd., Fort Worth, TX 76137.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking<PHONE_NUMBER>, to
request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    This action proposes to amend Title 14, Code of Federal Regulations
(14 CFR), Part 71 by establishing Class E airspace extending upward
from 700 feet above the surface within a 6-mile radius to accommodate
new standard instrument approach procedures at Mahnomen County Airport,
Mahnomen, MN. Controlled airspace is needed for the safety and
management of IFR operations at the airport.
    Class E airspace areas are published in Paragraph 6005 of FAA Order
7400.9W, dated August 8, 2012 and effective September 15, 2012, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document would be published subsequently in
the Order.

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would establish controlled airspace at Mahnomen County Airport,
Mahnomen, MN.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

     Authority:  49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9W,
Airspace Designations and Reporting Points, dated August 8, 2012, and
effective September 15, 2012, is amended as follows:

Paragraph 6005 Class E Airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AGL MN E5 Mahnomen, MN [New]

Mahnomen County Airport, MN
    (Lat. 47[deg]15'38'' N., long. 95[deg]55'41'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6-mile radius of Mahnomen County Airport.

    Issued in Fort Worth, TX on April 16, 2013.
David P. Medina,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2013-10182 Filed 4-29-13; 8:45 am]
BILLING CODE 4901-13-P


[Federal Register Volume 84, Number 211 (Thursday, October 31, 2019)]
[Notices]
[Pages 58436-58437]
[FR Doc No: 2019-23757]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2019-0034]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to exempt six individuals from
the requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs) that interstate commercial motor vehicle (CMV) drivers have
``no established medical history or clinical diagnosis of epilepsy or
any other condition which is likely to cause loss of consciousness or
any loss of ability to control a CMV.'' The exemptions enable these
individuals who have had one or more seizures and are taking anti-
seizure medication to operate CMVs in interstate commerce.

DATES: The exemptions were applicable on October 15, 2019. The
exemptions expire on October 15, 2021.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov/docket?D=FMCSA-2019-0034 and choose the document to review. If you do
not have access to the internet, you may view the docket online by
visiting the Docket Operations in Room W12-140 on the ground floor of
the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590,
between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal
holidays.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On September 6, 2019, FMCSA published a notice announcing receipt
of applications from six individuals requesting an exemption from the
epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8) and
requested comments from the public (84

FR 47042). The public comment period ended on October 7, 2019, and two
comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting exemptions to these individuals would achieve
a level of safety equivalent to, or greater than, the level that would
be achieved by complying with Sec.  391.41(b)(8).
    The physical qualification standard for drivers regarding epilepsy
found in Sec.  391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners (MEs) in determining whether
drivers with certain medical conditions are qualified to operate a CMV
in interstate commerce.
---------------------------------------------------------------------------

    \1\ These criteria may be found in APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5, which is available on the internet at
https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
---------------------------------------------------------------------------

III. Discussion of Comments

    FMCSA received two comments in this proceeding. These comments
supported granting these exemptions.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The Agency's decision regarding these exemption applications is
based on the 2007 recommendations of the Agency's Medical Expert Panel
(MEP). The Agency conducted an individualized assessment of each
applicant's medical information, including the root cause of the
respective seizure(s) and medical information about the applicant's
seizure history, the length of time that has elapsed since the
individual's last seizure, the stability of each individual's treatment
regimen and the duration of time on or off of anti-seizure medication.
In addition, the Agency reviewed the treating clinician's medical
opinion related to the ability of the driver to safely operate a CMV
with a history of seizure and each applicant's driving record found in
the Commercial Driver's License Information System for commercial
driver's license (CDL) holders, and interstate and intrastate
inspections recorded in the Motor Carrier Management Information
System. For non-CDL holders, the Agency reviewed the driving records
from the State Driver's Licensing Agency (SDLA). A summary of each
applicant's seizure history was discussed in the September 6, 2019,
Federal Register notice (84 FR 47042) and will not be repeated in this
notice.
    These six applicants have been seizure-free over a range of 12
years while taking anti-seizure medication and maintained a stable
medication treatment regimen for the last 2 years. In each case, the
applicant's treating physician verified his or her seizure history and
supports the ability to drive commercially.
    The Agency acknowledges the potential consequences of a driver
experiencing a seizure while operating a CMV. However, the Agency
believes the drivers granted this exemption have demonstrated that they
are unlikely to have a seizure and their medical condition does not
pose a risk to public safety.
    Consequently, FMCSA finds that in each case exempting these
applicants from the epilepsy and seizure disorder prohibition in Sec.
391.41(b)(8) is likely to achieve a level of safety equal to that
existing without the exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and includes the following: (1)
Each driver must remain seizure-free and maintain a stable treatment
during the 2-year exemption period; (2) each driver must submit annual
reports from their treating physicians attesting to the stability of
treatment and that the driver has remained seizure-free; (3) each
driver must undergo an annual medical examination by a certified ME, as
defined by Sec.  390.5; and (4) each driver must provide a copy of the
annual medical certification to the employer for retention in the
driver's qualification file, or keep a copy of his/her driver's
qualification file if he/she is self-employed. The driver must also
have a copy of the exemption when driving, for presentation to a duly
authorized Federal, State, or local enforcement official.

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the six exemption applications, FMCSA
exempts the following drivers from the epilepsy and seizure disorder
prohibition, Sec.  391.41(b)(8), subject to the requirements cited
above:

Taylor Bonvillain (MS)
James Klucas (KS)
Larry Lintelman (AK)
Charles Mershon (MN)
Brian Ranger (NV)
Adam Wilson (MN)

    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315(b).

    Issued on: October 24, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-23757 Filed 10-30-19; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 88, Number 93 (Monday, May 15, 2023)]
[Notices]
[Pages 30983-30985]
[FR Doc No: 2023-10295]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2019-E-5283 and FDA-2019-E-5284]

Determination of Regulatory Review Period for Purposes of Patent
Extension; Cablivi

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for Cablivi and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic
or written comments and ask for a redetermination by July 14, 2023.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by November 13, 2023. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 14, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2019-E-5283 and FDA-2019-E-5284 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; CABLIVI.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO may award (for example, half the testing phase must
be subtracted as well as any time that may have occurred before the
patent was issued), FDA's determination of the length of a regulatory
review period for a human biological product will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human biologic product Cablivi
(caplacizumab-yhdp). Cablivi is indicated for the treatment of adult
patients with acquired thrombotic thrombocytopenic purpura in
combination with plasma exchange and immunosuppressive therapy.
Subsequent to this approval, the USPTO received patent term restoration
applications for Cablivi (U.S. Patent Nos. 7,807,162 and 8,372,398)
from Ablynx N.V., and the USPTO requested FDA's assistance in
determining this patents' eligibility for patent term restoration. In a
letter dated December 23, 2019, FDA advised the USPTO that this human
biological product had undergone a regulatory review period and that
the approval of Cablivi represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
Cablivi is 2,998 days. Of this time, 2,752 days occurred during the
testing phase of the regulatory review period, while 246 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: November
24, 2010. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on November
24, 2010.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): June 6, 2018. FDA has verified the
applicant's claim that the biologics license application (BLA) for
Cablivi (BLA 761112) was initially submitted on June 6, 2018.
    3. The date the application was approved: February 6, 2019. FDA has
verified the applicant's claim that BLA 761112 was approved on February
6, 2019.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 1,216 days or 1,621 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to:

must be timely (see DATES), must be filed in accordance with Sec.
10.20, must contain sufficient facts to merit an FDA investigation, and
must certify that a true and complete copy of the petition has been
served upon the patent applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format
specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: May 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10295 Filed 5-12-23; 8:45 am]
BILLING CODE 4164-01-P