MR. HITCHCOCK: I think that's true, and I think - makes me think in my mind that our hearings are sort of show and tell. We don't have the audience that comes back to our - meeting to really help us - what we want to do by what we have learned in the hearings.

DR. MAYS: I think that means a different strategy, because I think - when you talk about populations, it's a little different than if you're talking about a code set where there is a specific group of people. It is their job. They are getting paid by their agency to go and watchdog certain -

MR. HITCHCOCK: Right.

DR. MAYS: Whereas, with Populations, that isn't the case. What needs, I think, more work in the sense of - when we have a meeting and we are going to discuss these issues, what would probably be useful is to use the email list that we have, thin that out as an announcement. Here's the agenda. People are welcome to come, because there are agencies within the DC area for populations in which they have offices, you know, the National Minority This or the Advocacy Office for - the ATI Health Forum. So, I mean, there are, I think, those types of agencies in Washington, as there are also, I think, for a couple of the foundations -

SPEAKER: Yes, the Robert Wood Johnson Foundation, I know for a fact, is very interested in building momentum, let's say, in terms of population approach to health. So I think that they would probably be very interested in the work that the subcommittee does.

DR. LOCALIO: But we're not exactly - I mean, they have a representative with us, so I don't see why what we are doing should be a mystery to them or vice versa.

SPEAKER: Uh-huh. Who's the representative?

SPEAKER: John Lumpkin.

MR. LOCALIO: John Lumpkin is what –

SPEAKER: Oh, right. Okay. But he's not on our subcommittee, but -

SPEAKER: No, he's not on our subcommittee.

MR. LOCALIO: But I know he certainly knows what we're doing.

SPEAKER: Right.

MR. LOCALIO: So I don't think we need anything more than that, unless he recommends somebody.

SPEAKER: Okay. Probably right.

MS. BURWELL: Vickie, I think this is going a little bit down on the agenda, but one of the remarks that Simon Cohen made at the Executive Subcommittee Retreat is that perhaps we do need to work more with the outside groups, in the example you gave on the health plans letter, perhaps holding hearings and workshops to determine barriers to collecting the racial and ethnic data and exploring methods to do so. So I think that your comment was right on the mark and there at least was one opinion expressed that we do that.

MR. HITCHCOCK(?): That's right.

DR. MAYS: I think that's a point well taken, but I think we could do hearings forever, but I would also like to see us with consistency, having people at the table who consistently take an issue to - you know - back, and they will stay for as long as the issue is there. So, I mean, when we move off their issue, they're gone, but what I get concerned about is they come, they indicate that they are interested, and we don't engage the mechanisms that we have to continue to let them know what we are doing.

I think this procedure now for making sure that things are up on the web earlier, so that people who follow the Federal Registry or who go to our website with our agendas getting up 30 days before will help. I mean, I think there's a series of things. The later that our things are up, also, the less likely we are to be able to get people to participate. So I think there is a confluence of that we want to try and work on.

So I guess the suggestion, at this point, would be that we move towards - and this, to me, is kind of administrative side - that we move towards thinking through how to extend ourselves beyond just having a small group of us involved, and I think we need to think about four particular issues. Who should be the people that we try and ensure are there to hear us as well as continue to participate?

Now, what would be the mechanism for doing this? Because, again, we have lots of discussion, but I am trying to make sure these things don't fall between the cracks.

MR. HUNGATE: Vickie, Bob Hungate.

A thought. You know, in the quality work group, the rights and ethnicity issue got talked about a lot, and whether it should go into claims or not was a question that was left open.

In addressing that, a way to go about it might be to invite health plans to a hearing to present the issues that are related to that, which then might lead to a letter to the Secretary talking about what would need to be done, based on the hearing, and then you've got somebody poised on the customer side to work on it.

So my sense is that picking a specific thing that we would like to see get to go and then saying who's got to do the work and have the people that are going to have to do the work be the testifiers, then you've got conditions similar to what standards and security follows in the way they work, at least, that's what it seems to me like they are doing. Make any sense?

DR. MAYS: Makes sense to me.

SPEAKER: Yes.

DR. MAYS: Other people?

DR. BREEN: Sounds like an excellent idea. If there were maybe a - your group is a work group, rather than a subcommittee, is that right, Bob?

MR. HUNGATE: That's correct.

DR. BREEN: So maybe a joint hearing between the subcommittee and the work group, and Bob could help target the people, and it might lead to what Audrey was suggesting, which is to have these targeted hearings for people who would actually be implementing it, and, in fact, they could be the testifiers and to talk us about what their concerns are and it could help us make stronger recommendations.

I think the workshop is a good idea, too, and maybe it could lead to that eventually, but that's a kind of a bigger task.

MR. HUNGATE: Well, Vickie, I'm going to have to run in about five minutes, and I want to apologize in advance for running out, but the quality work group is working on its report this afternoon, and one of the pieces in that is the race and ethnicity - if you will - in the private sector. So I think that is really set up for action, and the quality work group would be happy to help in whatever ways appropriate, if that is the right action for the subcommittee.

DR. MAYS: It sounds like, from what we are saying, that that may be a model to get us started on it, because I think that that will also interest the people doing code sets also, and so that may be the galvanizing piece across the groups.

So, Bob, I appreciate that suggestion and what I'll try and do is chat with you tomorrow about - after you have had your meeting, chat with you about it. So I think if you would tell your group that we are interested, then let's talk and see how we can make this happen, and I think, again, we need to kind of look at it -

MR. HUNGATE: Be happy to do that. It's not clear yet whether we'll have a group this afternoon or not, given -

DR. MAYS: Oh -

MR. HUNGATE: We'll try.

DR. MAYS: Yes. Okay. All right. Thank you very much, Bob.

Okay. So that is helpful in understanding why, for example – because when I read the minutes in terms of the issue of kind of the effectiveness of this group, I was trying to get a better sense of it, and this has helped to capture it.

Are there any other suggestions that people have in terms of changing the way we approach issues or who we might have at the table?

Jennifer, in terms of NCVHS, any suggestions there in terms of our ability to be more effective with NCVHS?

MS. MADAN: I'm not exactly sure what you are asking me.

DR. MAYS: What I'm asking is we make some recommendations for NCVHS, but I think also for NCVHS it comes down to budget issues.

MS. MADAN: Yes.

DR. MAYS: And so things kind of get stuck. I mean, there's a great willingness within NCVHS for many of the issues that we raise, but it comes down to two things. It comes down to budget and it comes down to the resources that you have in terms of people power to actually do things. So I was asking you to think about whether or not there is also a different approach for us to take that could facilitate making things happen.

I don't know whether it is a matter of we need to work with other groups that have similar issues to yours that will then make the priorities go higher. I don't know whether it's a matter of we need to take smaller pieces of your issues. You know, sometimes our goals are a little lofty and it's like go do a whole survey and maybe we should at times recommend requesting analysis of data to present a better case for going doing a whole survey. So that is kind of what I was getting at.

MS. MADAN: I think you hit the nail on the head. It's mostly budget issues, and most of the recommendations are really big-ticket items that either require expanding sample or - sample or doing something - many of those things are clearly things we want to do.

So where I see the most impact is being able to use the committee in our budget negotiations that this isn't only something we want to do, but that it is something that is needed. To the extent that you can influence the data - the department, others that use our data and don't have what they want to say so, I think that's the big picture.

Now, if there are smaller ticket items that would be helpful, then I think those - you know, that we would do our best - but most of the things that I have seen, you know, maybe over the last - many years have been really big, big - big ticket items.

In terms of staff, we don't have a lot of extra staff. If it's a smaller kind of analytic project, that's one thing, but very large projects, you know, we are kind of robbing Peter to pay Paul most of the time.

DR. MAYS: Anyone else want to comment on this issue? Virginia, in terms of NIH?

MR. LOCALIO: Vickie, this is Russell. I would like to comment, but I'm not going to, not on the record.

DR. MAYS: (Laughter). Okay. Can we go off the record?

MR. LOCALIO: No.

SPEAKER: - puts his pencil down.

DR. MAYS: No, we're actually being taped.

SPEAKER: Are we?

SPEAKER: Oh, yes. Oh, yes.

DR. MAYS: Yes.

MR. LOCALIO: So for future meetings -

THE REPORTER: We can turn this off.

MR. LOCALIO: No, for -

DR. MAYS: Yes, that's the request I'm making.

MR. LOCALIO: Do you want to turn it off?

DR. MAYS: Yes.

(Comments off the record).

DR. MAYS: Whether or not that might be a time for us looking at some of the specific recommendations to say - to then have a discussion with you about that and what the costs would be and what a strategy might be in terms of our group responding to the disparities report.

MS. MADAN: Yes, I think we could probably put together a briefing kind of maybe not explicitly on those recommendations - but, as I recall, they are kind of general, in terms of populations covered and so forth - with estimates we have come up with about various changes to the surveys that would meet - and different ways of meeting some of the subgroup estimates is really what we are talking about, and you don't even have to go as far as the new reports. You just go back to healthy people. It's all over the department, so those kind of issues are - I think are very appropriate for us to be giving you some estimates on.

DR. MAYS: Okay. And –

MS. MADAN: When is that meeting?

DR. MAYS: March 4^th and 5^th.

And, Audrey, can you call and get our arc(?) partners at this meeting? That would be Kay Felix Arend(?), Harvey Schwartz. Did we have a third person - I can't remember who it is. The guy from quality, Eduardo.

SPEAKER: Ortiz - Eduardo Ortiz.

DR. MAYS: Edward Ortiz. Thank you. Yes. I think we should ask them, in particular, to attend. They're very aware of the committee activities, and I think that would be a good group of people, because then they can tell us any plans they have in this area, too.

MS. BURWELL: I just also wanted to ask that there are other departmental data-collecting systems, such as SAMSA, and do you want to hear from them?

DR. MAYS: No, I want to do this piece by piece right now.

MS. BURWELL: Okay. I mean, you know, we are getting to - if it gets big, it's a whole hearing. This is a report that came from - apparently may have some plans as to what it wants to do. We also know that they are asked now to do this annually. So I want to kind of take this piece, which would be to deal with that particular report, and, hopefully, there will be energy around the department for dealing with that report, given what is going on in the media right now.

DR. MAYS: Um-hum. All right.

Okay. All right. Anything else? Can we wrap up this particular issue about the - I think this is very good because it really addressed issues that I had planned to address in a different way. I think this is a good way to deal with the subcommittee and its work and really getting it to engage in a leadership role that I think it can engage in, as opposed to just a - I think - a response role.

DR. BREEN: Vickie, I think that I really like the direction you are taking this in as well, and I just wanted to bring up one other issue which we have brought up again and again around data collection, and I don't know if NCVHS has estimates on this or if it would be Census or another meeting, but I just wanted to remind us of the desire and the need that we have targeted, identified from collecting concentrated samples in small areas, and that, I think, is a pretty expensive endeavor, but I don't know.

Is that one of the things, Jennifer, that you were thinking of - that you have made estimates for that you could incorporate in that meeting or is that something separate?

MS. MADAN: You know, for HIS, all of our - we work pretty closely with Census on the estimates, but we kind of are using some generic costings here, and the - we can talk in global terms about what these various different approaches would be.

You know, they will be estimates. They are not going to be something that you can say it'll cost this exactly, this amount of dollars, but - give you an idea of the order of magnitude. Exactly how you do it can make some differences.

The kind of basic cost factors are pretty standard, and it is actually, in some ways, steeper to do a bigger concentration in one area than it is to do lots of areas. So if you want to just expand the sample in a particular area that is really cheaper than trying to just expand the entire HIS.

So we can talk about general things like that and tradeoffs and what you get and what you don't get and how these kind of focused subsamples effect the totals, if you want to make estimates about the total country. So it might be useful to have some of that discussion as well as part of this presentation.

DR. MAYS: Nancy, that is a good point. What I would suggest is that if we want Jennifer to talk about that, that the people that we add to inviting to the table to hear the presentation would be the foundation, because I don't think it would be unlikely that you could see Commonwealth or Kaiser or potentially Robert Wood Johnson actually doing that kind of work.

As I said before, I think, in some instances, it's a matter of there are other partners who also might get this work done, or, as I also understand, CDC has this foundation, and sometimes when they are looking for additional resources, that is one of the ways that these outside agencies can partner with them to ensure that these things get funded.

So, Jennifer, are you comfortable with - if you are doing that kind of presentation? Because, again, these are people that I think we need to partner with anyway, because they do have interest, and they have, in the past, been at some hearings.

MS. MADAN: Yes, I think I'm fine with it. Let me check some dates and let me talk – also want to talk a little to Dale about how to best do this, but I think it's - we don't need to assume everybody lives in our little sampling. Maybe we need to provide some of this basic information about how we do what we are doing, and maybe people have some ideas about how to do it differently. Be fine.

DR. MAYS: Okay. All right. So, Dale and Audrey, I will work with you about these other invitations, and we'll look at, with Jennifer, the time, whether it's like the subcommittee breakout or whether it's the day before. So let's look at that also. Okay. Great. Thank you, everybody.

Virginia, did you want to comment at all on anything else in terms of the - the Executive - in terms of like the travel or the - can't remember. There was something else in this item.

DR. CAIN: Well, we had raised the issue - the issue came up about the travel, and we discussed it. This is for committee members to attend hearings and the fact that it really primarily falls on the individual departments or agencies right now to support that travel, and I think that there - through the discussion - came to be – well, I think certainly starting out, I don't think that there was exactly an awareness of how it didn't have individual, say, branches budgets, but it really - at least at NIH - does not come from some central point, and the sense was that there should be an investigation of how there might be the possibility of raising some additional funds centrally, but there was certainly no guarantees, and the hope was, through these letters to the various agency heads highlighting the importance of the work of the committee, that there might be some additional support from the individual agencies, but I don't think that there was a real resolution as to how we are going to move from the current situation to something where there might be some kind of a central fund for it. Really, that would be the way to go, but, realistically, it doesn't seem like that is going to happen, to a great extent.

DR. MAYS: Is this something we can put at the level of the Director's office, something that either a request or your having a discussion with Reynard or Zerhouni would be a way to go on this?

DR. CAIN: Have a pool of money from OD(?) set aside for travel -

DR. MAYS: Yes, that what happens is that there's a recognition that when individuals participate that the budget structure of NIH is such that the monies are typically put in branches for travel specific to the research agenda and research mission, but that, at the same time, there is a greater departmental relationship to the issues that are being discussed, but there are not the resources for individuals to travel, and so, therefore, it might be through the Office of the Director that when there are not funds within the branch that the request can be made to the Office of the Director to travel members to meetings or hearings.

DR. CAIN: I think it is certainly possible to initiate that discussion. I think the response might be that there would be an NIH representative then which would -

DR. MAYS: No.

DR. CAIN: - not necessarily get the committee members there that would like to participate.

DR. MAYS: Oh, okay.

DR. BREEN(?): I think that's right.

DR. MAYS: Well, maybe we better leave that alone then. (Laughter). We'll lose on that one.

DR. BREEN: There is another travel issue, though, that I wonder if it was discussed, Virginia, and that is getting people who give testimony there, because, similarly to what we were discussing before with some of the committees standards or what not, there's industries that are interested in these standards that have money and employees and resources to send people to the hearings. Whereas, Populations don't necessarily have those resources, and so was there any discussion of a travel budget for this group to bring people who need to testify?

DR. CAIN: I don't recall a discussion of that issue. Dale or Audrey -

MS. JACKSON: Hi, this is Debbie. Just that Marjorie indicated that the standard number of testifers we bring in are about three or four, and we ask that to be justified in the language, so that we have information when we have to prepare our own committee management budget and accountability that way. So, generally, the hearings have kind of stayed in that ballpark. If there have been any additional people, then, that's kind of taken on a case-by-case basis.

DR. MAYS: See, that's the problem that we encounter is that we never know until the last minute, and it's a bunch of stress, as far as I'm concerned, that enters into the planning process that - you know - something needs to be done about it. You know, usually, three people coming in is a one-day - it could be even only an afternoon. When we put a hearing together, typically, we have more people than that, and the problem is is that people that we bring in are either data users, community folks and sometimes the agency, and they don't have the resources.

Now, what is fascinating to me is that we can spend the money in travel, in the sense that one of the reasons we don't do it in DC as much is because of that rule, so then we start traveling, all of us, someplace, so that we can hear from people in those places, because, otherwise, it's too difficult to bring them to DC, but I guess I am just uncomfortable with the fact that we have to sit and wait to know whether or not we can have Person X and Person Y. When you say it's a case-by-case, I just don't know if there's some other way we can do this that -

We can spend X amount of money on travel. So then we would sit down and say, okay, for this hearing, we are going to have 10 people. For this hearing, we are going to have four people, but that we can just plan, is there not the capacity for a committee to have at least an operating budget that it can think about - I don't say it has to be in our hands, but I say that we have some sense of a budget at least, in terms of being able to make plans? I mean, I don't know how others feel about that. I don't know if that's even -

MR. HITCHCOCK: I think it's a good idea - talked about this before and we never really followed up on it. I would like that - to have that sort of a travel budget as far as subcommittee, I guess even an approximate one, like you were saying, Vickie, something, as Debbie - could probably help us or Katherine or someone.

DR. BREEN: And the trick here, I think, is that - I'm not sure if we want an actual budget or if we want an average number of people to give testimony, because I think one of the things we have observed is some of the outlying areas in this country are very, very far away, and travel from the Marshall Islands, I mean, we worked out a phone call last time which worked extremely well, but -

MR. HITCHCOCK: It worked well for us. For them, it was like 4:30 in the morning.

DR. BREEN: So, you know, travel could be very cheap or it could be very expensive, and so I think it's just important to have an adequate number of people there to provide the testimony we need, and that is really - we need a lot of flexibility around that, I think, in terms of money, what it is going to cost.

DR. CAIN: I think it goes back to the earlier question when we were talking about the - recommendations for the report on health disparities that we were given a charge for a certain task, but without the resources, how is that going to happen? How can we fulfil our mission?

So unless we have access to some resources for travel, either for committee members or for persons to come and testify at hearings, I don't see how we can do an adequate job of really getting the information that we need adequately.

MR. HITCHCOCK: Even if we knew how much we spent last year in terms of traveling our own members and staff in bringing in speakers will be helpful to know how much we were allowed.

MS. JACKSON: Hi, it's Debbie -

SPEAKER: That's a good idea. That would give some kind of benchmark.

MS. JACKSON: Keep in mind that - this is Debbie. Keep in mind, we are looking at several accounting line items in talking about bringing in NCVHS staff and the cost of the room. That is one area. We have - it's a different line of bringing in speakers. So what we can do is look at the last couple of hearings, get a ballpark of the number of speakers that were brought in and the cost for that and give you more of an average, so you can look at it in terms of figures.

I would like to think that the hearings that you've had and the speakers that they have been successful in that you had not - you didn't have to make any decisions where someone did not come because of a number of speakers on the panel or the hearing. I think if we look at the agenda from last year that, generally, from what I recall, those that you needed to have there to make your presentations, there were accommodations made so they were there either by phone or in person. So just so that you are not caught at the end trying to determine who can or cannot come depending on funds, we can look at the number of people you've had at the various meetings and just kind of use that as a balance.

DR. MAYS: I do think that there were times in which we made different decisions based on struggling with this issue, and I also think, for example, in the last hearing, we were flying by the seat of our pants on costs, and then Audrey stepped in and really assured us to not worry about those things, because her office, for example, was going to help.

MS. JACKSON: Right. That's true.

DR. MAYS: I mean, if we raised that we want to have a phone call from the Marshall Islands, we get people going ballistic, and in this last hearing, it was very different, because Audrey was able to get Dr. Simpson to say that - we planned freely, regardless of what happened as to who was there or who was not there. What Audrey was able to do was to move forth with the recommendations of what the subcommittee wanted, because we had the knowledge that we were not going to have any barriers about if somebody from Palau wanted to - Audrey was - making that happen, even if it meant flying here with a $3,000 ticket. That's very different – I'm telling you, it was a very different way to work than when every time we come up with a name, we instead try and find somebody – well, are they with a state? Are they with the Federal Government? Maybe we - I mean, we don't get to choose who we think will provide the best testimony. We were choosing by who is the cheapest, and that, I don't think, is the best way for us to do our business, and I think that is what we are really saying, Debbie.

I mean, so don't think that because we had the people there that those would have necessarily been our first choices, but those choices were made within a constrained budget environment, and I don't say that we would just decide - if we knew our money - that we would just decide to bring everybody from Hawaii in. I mean, we are not doing that, but it does make a difference in how we plan. We start changing our first-level name to other names because we become concerned about, well, who can do this and it would be less money.

So I guess I'm wondering, in this discussion, whether it would be helpful to have Marjorie present or not or whether we want to continue this at another time. What is the group will on this? Because Marjorie is just upstairs in another room?

MS. JACKSON: That's right, and she can come on down.

DR. MAYS: Yes, we can actually ask her to join us and - you know, because I think we've gone around and around, and it is just time we either make some decisions or that - you know - we have to just move on. I mean, because this committee has asked for this several times -

MS. JACKSON: Right. Quite aware of the requests.

DR. MAYS: So what would you like? We have said our piece. We could either wait for Debbie to give us some information or we could talk with Marjorie now or we could talk with Marjorie after we have some information.

MS. JACKSON: This is Debbie. You can go on on the agenda. I can give her an update of what the request is and then she can always join us sometime in the morning, if that is information you want to get from her.

DR. MAYS: In the morning?

MS. JACKSON: I mean, later on this morning. You're going to have a break –

DR. MAYS: Oh, oh, oh, today. Today, you mean. Is that what you mean?

MS. JACKSON: Yes, later on, after a break, just find out where a window would be for her to plug in and give you her response.

DR. MAYS: Okay. What do people want?

DR. CAIN: Well, I think it would be helpful to just reiterate exactly what the request is. Is the request to have a specific budget and then be able to live within that, making the decisions as to who the best people are?

DR. MAYS: I guess I was hearing Nancy say that it's not so much we want specific numbers, but that in the sense of having kind of ballpark - because I don't - again, I think that we can't say we are going to do exactly what we did before, but having some ballpark idea of a framework that we can operate in.

Like, for example, what are the ranges of the cost of hearings? I mean, it might be useful for us to even get a - some of the other subcommittees have three-day hearings. I mean, we have rarely had a hearing for that long, but they have three-day hearings. So what is the cost of putting on a three-day hearing? And then, separately, you know, something about the ranges of travel, because I don't think we are trying to live with a specific budget, but I think we are at least trying to get some idea of if there is X amount of money, we may want to - or some range of money - we may want to spend it as opposed to we don't know, so we don't spend it.

DR. HEURTIN-ROBERTS: Yes, this is Suzanne. I agree, and I think also, rather than a specific budget, what we are looking for is some sort of mechanism and assurance by which we can travel people when we need to in order to do the work of the committee. I think that, right now, we just scramble around, ad hoc, each time we have a hearing, and if there were some mechanism, some process, an assurance that there would be a positive response when there was a need to travel persons for testimony, then that would go a long way, I think, to solving our problem.

SPEAKER: I guess - I mean, I agree, but I just think - I'm afraid the response would be, well, we can't really tell you until we know how much it is going to cost or something like that. So I think it's good to get the information and it might be followed by a more specific request.

MS. MADAN: I think that's right, because I think we need more information, and I think the idea of finding out what a three-day hearing or some of these top-of-the-line hearings actually cost, because Vickie and others on the subcommittee have been really outstanding in terms of finding other conferences that we could go to and - speakers from, and then all the agencies have subsidized these conferences by us traveling to them rather than them coming here. So those are the ways in which we have subsidized these hearings, and so I think we need to factor that in, and then just point out that we need a larger budget in order to have more flexibility and to get the best people in for these hearings.

DR. LENGERICH: Vickie, this is Gene. I guess I would also wonder if comparing our hearings to the other subcommittees' hearings is the appropriate place to begin, because the people we are often inviting are those who are employed by public agencies or are members of voluntary groups who may have very limited travel budgets of their own, and so, therefore, we do pick up the tabs on those, but some of the other subcommittees may be inviting members of well-funded, private organizations to handle the travel on their own.

MS. MADAN: Actually, Gene, what I was thinking is that we factor in the costs that those companies are spending.

DR. LENGERICH: Well, we didn't say that explicitly, so I think that we need to -

MS. MADAN: - because that is exactly what I was meaning, what the total cost is, not to the government, but the cost of those hearings.

DR. MAYS: See, Gene, that's what I meant is that, for example, when - a three-day-hearing, this is in line with what Debbie was saying - that is a different line. So putting all the travel aside, what does it cost them to do a hearing for three days? That means the taping, the rooms - because they travel in their hearings also. They're in hotels sometimes, very similar to the way that we are, and we just have exercised such caution. I mean, you know, we are operating from a poverty model. We're kind of at two days and then that's about it, but that is actually not the way that some committees have worked. They have actually had three-day hearings if they needed to, and they have traveled around. So it would be useful just to see the cost.

I think the travel thing is a little different, and I think Nancy's point is well taken. For example, NCI subsidizes us. So that travel doesn't even get considered, to some extent.

So I think when we start looking at it, it is with trying to think about, for some of the other hearings, the difference between what is paid for and what is subsidized, which is very clear that I don't think we have in Population the kind of built-in audience for subsidies, and I think that is the recognition that we need to put forth, that this rule of three may not be as useful of a rule for Populations as it is for groups in which it has the capacity for greater subsidy.

DR. LENGERICH: Yes, I understand. I just think those who are testifying are probably traveling on different budgets for the Subcommittees on Standards, as opposed to the Subcommittee on Populations, and if that all has to come out of the budget for NCVHS, if the travel is allocated equally between the various subcommittees, then it is not going to be represented appropriately.

DR. MAYS: Oh, I don't think the travel is equal.

DR. LENGERICH: Yes.

DR. MAYS: Yes. So I agree with Nancy. I think we want to figure in some of these subsidies.

SPEAKER: Well, maybe Gene's other point is that they are traveling in luxury accommodations that we wouldn't use. Is that your other point, Gene?

DR. LENGERICH: I don't know that that is the case.

SPEAKER: Oh, okay.

DR. LENGERICH: I'm just thinking that the people who are coming from health-care organizations - data-standard organizations for private health-care industry, their companies are picking up their travel and not being charged to the committee.

SPEAKER: Right. So we would need to add in those costs in terms of what a hearing would cost.

DR. LENGERICH: For our group, correct.

SPEAKER: Correct, yes.

MR. HITCHCOCK: Let me just say - make a couple of points here. One is that I think a lot of information is probably going to be readily available in the business report that - does every year with how much we have - the committee has spent on meetings - so forth. I wish you had a copy of this.

DR. MAYS: Oh, okay.

MR. HITCHCOCK: The other part is I worry about the subsidy issue, NCI and others, because I think the general feeling, as reflected in our notes from the Executive - retreat, is that agencies should be picking up the expense to send their staff to the full committee meetings or to the hearings that we have in other places. So I'm just worried about talking about being subsidized by other parts of HHS.

SPEAKER: Do most of the other subcommittees meet in Washington most of the time or do they do a lot of flying around like we do?

MR. HITCHCOCK: It depends on given place and time - the vision for health statistics - so they've got to have a lot of travel going on about that.

I think, in general, another topic that came up - at the - retreat is we really probably should stick to Washington as much as we could, and we probably really should meet in Federal facilities and not in hotels, not be hidden away in Silver Spring, is one of the examples that they used. I think it was a standards and security meeting had met a couple of times in Silver Spring, and people had trouble even hearing about the meeting and finding it.

DR. EDINGER: Vickie, also, this year, the APA - meeting is here in DC, so some of the groups that might come to that, that might be a good time to have them in, since it's here anyway.

DR. MAYS: Yes, I was thinking that this next one is - if we do something, it is very easy, because it's there, but, I mean, we have traveled, again, because of cost, where, you know, like the targeted populations are in geographic areas. So we went to those geographic areas or we took ourselves to meetings that were being held -

MR. HITCHCOCK: I think we were justified.

DR. MAYS: Yes.

MR. HITCHCOCK: I don't think - I think we were certainly justified.

DR. MAYS: Yes. Okay. All right.

MR. HITCHCOCK: There were a couple in the year, one or two, when we did a lot of travel.

DR. MAYS: Okay. Let's summarize what we are going to do on this, so that, again, it doesn't fall between the cracks.

Debbie, I guess a request for you would be that it would be helpful to us to get some information on costs, and that would be to give us a sense of the cost, for example, of the travel for hearings. I think we want the costs on site, off site, you know, when it's there, if a committee has a hearing for three days, what that is like. I think it would be useful to give us, because you can't estimate when you are looking at those hearings in terms of like say - I don't know - privacy or standards and security the testifiers and how many of those testifiers, on average, you are paying your travel for, because I think we are going to find out that, for some of these, it is probably few, and that that is the difference for us is that it's many more.

Anything else that we want from Debbie?

DR. EDINGER: We want to look at the possibility - depending on where the hearings and the groups are - like using an HHS regional office, because there's 10 of those around which wouldn't cost us anything. The Federal facilities or maybe a teleconference or something from a university or something where the group of people come to one place it might be cheaper to pay for one place or a Federal facility of some sort somewhere than actually going somewheres. I mean, I don't know who we are going to have and when, but we might want to look into some of those possibilities.

DR. MAYS: Yes, and, again -

SPEAKER: We've been doing that.

DR. MAYS: Yes, I was going to say, again, I think we have been trying, to some extent. The question is probably if you compare us maybe to some of the other groups whether or not the other groups have also been doing that.

I mean, one of the things I want to make sure of is that, as we talk about these cost-saving measures, that all of the subcommittees are doing that, as opposed to just Populations. So if we are suddenly going to be in the Federal facilities, then I would expect that all of us are doing that, if we are suddenly expected that we are bringing in people from Federal agencies, that we are all doing that kind of thing.

So - but I do think it may be worthwhile for Debbie to take back some thinking about the ability to be able to facilitate that. I mean, my experience of our hearing when we did move to a university with great technology that our contractor was not able to really facilitate these things happening in the ways in which it should have been able to happen. So, I mean, that is the other thing, and it may be that we need to also look at the services that we get from our contractor, but I think that is out of the scope of us as much as we have already commented on that, and that that may be something when it comes to costs for Debbie or Marjorie or somebody to also look at, whether or not services that we would need are being best provided in the context that we are asking.

So – okay – anything else or we'll move on?

MR. HITCHCOCK: Vickie.

DR. MAYS: Yes.

SPEAKER: I do want to move on a bit, but I want to also relate to ask a question.

A while back, we had talked about writers for reports, and -

DR. MAYS: Your voice is dropping, at least for me. Can you –

SPEAKER: I'm sorry.

I was wondering if there had been any discussion at the Executive Subcommittee about writers for reports that the committee might be wanting to produce.

We had talked about - as a subcommittee, we had talked about several reports, and I think we were desirous of having a writer contribute to that, and I'm just wondering if that topic had come up at the Executive Subcommittee. It also had budget implications. So I was wondering if there is any update on that?

DR. MAYS: I think for some of the reports, we were moving towards a contractor, but - a contract. I'm sorry - but maybe you all could comment. I don't know if that was discussed at all.

MR. HITCHCOCK: I don't remember it being discussed.

DR. MAYS: Did they ask - I mean, sometimes, at the retreats, they want to know what projects are underway, because of the budget implications. So were any of our projects discussed?

MR. HITCHCOCK: Audrey? Debbie?

MS. JACKSON: Just your ongoing hearings and plans to develop your reports from the hearings.

DR. MAYS: Oh, okay. So we are on your budget radar, right?

MS. JACKSON: On the accountability for the reports, yes. That's right.

DR. MAYS: Okay.

MS. JACKSON: I think we have already had the contracts. We have had several writers contracted for populations. So it's just kind of compiling the material and getting your statements as to what you want to prepare in your report.

SPEAKER: Good. That is gratifying to hear. Thank you.

DR. MAYS: Okay. All right. Let's move on to our letter, because I want to make sure that we get that - oh, sorry.

MR. HITCHCOCK: As I said, there are very limited notes that I took and it had to do with our subcommittee encouraging the collection of reporting - data at the provider level. This is something that Simon Cohen talked about quite a bit. He suggested that we look at best practices for collecting plain data on race, ethnicity, and he talked about at the time of enrollment.

Other than that, the group talked about that's not really the easiest way to convince people of - origin to give us this data, because it's sort of - they are suspicious of how it might be used at the time of enrollment.

But, anyway, in any event, Simon was thinking that we ought to look into this, and a fresh, new look is needed, and I had written here that it is clear that the subcommittee needs to involve - the private sector - and providers, and we talked a little bit about what was going on at Aetna, for instance.

DR. MAYS: Right.

MR. HITCHCOCK: In getting the point of view of the providers - this is sort of an issue - a couple of different committees, something that, I think, the consensus of the Executive Subcommittee was that we ought to be doing more of this.

DR. BREEN: Could that be incorporated into the joint hearings that we discussed with Bob Hungate's group?

MR. HITCHCOCK: I would think so.

DR. MAYS: I was going to say that is the kind of example of a three-day hearing where you bring both of those in and what you try and do is have Bob's group for one and maybe Simon's groups for another.

MR. HITCHCOCK: Right.

DR. MAYS: And then a day of discussion. So that - I think we may want to think about that, Nancy, relative to structuring what we just talked about would be to involve the other committees in it, and that might be something out of which we would want a report to come where we would want to have a writer at the start, and not at the end, I agree.

Okay. Let's have some planning time to talk about this. So I am going to ask Audrey to - as a followup for us to be able to have a subcommittee conference call and to ask Bob and Simon and John to join us. I want John to join us on it because of his role relative to - Robert Wood Johnson has had a hearing, I think, or – I'm sorry – a meeting with the people at the planning. John is quite interested in this. So let's see if we can have them join us for a call where we can get a sense of the broader landscape of what they are thinking about, and then we can plan a hearing.

Okay. Thank you very much, Dale and others who were at that Executive Committee retreat. It sounds like, at least from the Population side, that I have a greater understanding of comments that were made, also, the suggestions that they made to, I think, kick-start us in a direction. If we could just take care of some of our structural issues, I think we'll do well.

Agenda Item: Review Draft Letter on the National Children's Study Recommendation

DR. MAYS: So okay, can we turn our attention to the letter?

Gracie, are you there?

MS. WHITE: Yes, I am.

DR. MAYS: Is Leslie - can you call and see if there's any – I know Leslie's branch is having a meeting. So I don't know whether it's possible or not possible for her to join us.

MS. WHITE: All right. I'll give her a call.

DR. MAYS: Thank you.

But let's start by - I mean, I can give you much of the background of the letter, and many of you were at the presentation that was given to the full committee.

I think everybody on line is aware of the study that NICHD, CDC and ETA - I think that's - is that right? Are those the three, Audrey?

MS. BURWELL: Those are the three prime -

DR. MAYS: Yes, the three primes that are organizing, in terms of the National Children's Study.

We had Peter come in and we had a series of questions that we had, many of which were addressed by Peter, and some of which, I think, there has been some subsequent conversations with him about.

The choice for the subcommittee was to write a letter expressing some of this - areas of interest, ensure that, because the study is so early in the formative stages that it would be useful to get our concerns on record, and so, hence, you see the letter before us, which was worked on by a smaller group of people before it went out to the full committee for - I'm sorry to the full subcommittee for comment.

The discussion that ensued about the letter really has more to do with the direction and what we want to do with it, and that is do we want to just present these points as we have learned them from the hearings, and here are the things we want you to think about or present them in a way in which we are asking them to actually respond.

Now, Jennifer, are you on line?

MS. MADAN: Yes, I am.

DR. MAYS: Oh, okay.

I do think that, again, it is kind of apropos of our earlier discussion this morning that - you know, some of this is pie in the sky and it's - the survey then does everything. So I think the point is well taken that we can't expect one survey to be able to answer all - I forget how many points there are in there, 10, 12, 15, something like that - but that, instead there is some thoughtfulness that are given to those points might be an addition that we want to make to this letter.

But I think what we need to talk about as a committee is what we hope to achieve, because, again, if it's going to be a marker later about did we hit the mark on things that we are sending, we ought to have a clear sense of what do we want to see happen as a function of this letter, and I think that that may be a broader discussion for the committee.

My perspective of what I think would be useful to have happen as a function of this letter is that it really promotes a discussion about the importance of these issues and that the issues are discussed early in the study. The study can be clear about what it can do and what it can't do and that everyone who participates is well aware whether or not the study, for example, will include significant numbers of which racial and ethnic groups that will be available for analysis, whether or not, for example, the study is going to look at the issue of health disparities, whether or not the study is going to ensure that there are variables that allow them to do social determinates, whether or not, for example, the study is well aware, as we are, of the kind of privacy and confidentiality concerns that racial and ethnic minorities might have that need to be planned into the recruitment and retention strategy for this study. I mean, I have heard little about retention. In a longitudinal study of this magnitude, there are certain populations that retaining them is quite difficult for the amount of time that they are talking about.

So that would be what I see as an important role, so that we don't find ourselves four or five years down the line that this group is worrying about the same things that it worries about with some of the other surveys that are already on line.

Other goals, comments?

DR. CAIN: Well, I'm trying to find my copy of the letter right now.

Let me express some of my general concerns about the study and some of the directions that it is taking that I think that we might be able to help with, and one of them is that this seems to be a move to only include things in the core hypotheses that require the sample size that they are talking about. So some of the more general behavioral and social issues that you could answer with questions, that you could answer with a smaller sample size may not make it into the core hypotheses.

However, I think that when we are talking about trying to get some of these racial and ethnic subgroup estimates, that even that 100,000 quite quickly turns out to be not as large a number as it initially starts out to be.

DR. MAYS: Oh, without a doubt.

DR. CAIN: So if we can really emphasize the point that to get some of the answers that we want for racial and ethnic subgroups, even on some of the hypotheses that, in theory, you could use a much smaller sample size, but we've really gone a long way to helping get some of the more basic behavioral and social-science questions in there.

And I know other people at NIH, certainly, are well aware of the study and they may have some other thoughts.

DR. MAYS: Any other comments from others?

DR. BREEN: I had a kind of a general comment about the organization, and I was trying to think about this from the point of view of the reader as well as what we are saying, because I think we want to know about these items that are bulleted, and I think they are important. So –

DR. MAYS: Before you go to that, let's see if we can get some comments on Virginia's recommendations, because I want to get a sense of -

DR. BREEN: I think she's right.

DR. MAYS: Let me ask, because I'm not clear, Virginia, are you arguing that there be more social and behavioral-science questions in the core sets?

DR. CAIN: I'm concerned that a lot of it is going to be lost.

DR. MAYS: Yes. Okay. I just wasn't clear what sort of the results was that you were arguing for.

DR. BREEN: You know, Virginia, one thing I'm wondering, is this going to be a public-use data set? I mean, is this going to be data that is collected and available so that people can formulate and answer their own questions with it or are we going to be limited to the findings that the group of researchers who are working on this ask and answer?

DR. CAIN: Well, I think that there is discussion on that. Now, there's many people that believe that it makes absolutely no sense to collect something of this magnitude and not have it widely publicly available, but there has been no mechanism that has been worked out. There's no set of rules as to how that might happen.

DR. BREEN: That should be among our concerns, shouldn't it?

DR. MAYS: Oh, yes, but I thought that – and, again, I always find it fascinating what rules we would be held to if we were applying for this versus kind of its structure - that when something is over 500 K that there are a set of data-sharing plans that are included. So I guess I assumed that this study, given - and I just focus on data sharing - that that would have to be the case.

DR. BREEN: Well, the thing is, Vickie, that unless mechanisms and money is appropriated to put this up as a public-use data set, there is a lot of work in cleaning the data and setting up - like, for example, Ask Chis(?), that took a whole - a staff person and quite a lot of staff working with him in order to come up with that. So that has to be a focus and that has to be all planned for along with the data planning for the public-use sample to be developed and available to the public in an easy-to-use way and in a timely way, and I think that the issue is complicated by the fact that this is a panel survey, a longitudinal survey, and so how often would it come out, and the researchers who work on this are going to want lead time with the data. They are going to want to be able to use the data first, I bet.

MR. HITCHCOCK: And it's not as simple as it used to be to hang onto data like that. I forget the name of the - Julie may remember this – and Wendy Baldwin had a lot to do with this when she was at NIH, but it's - those sorts of data are what we call - just can't hang on or contractors just can't hang on to data like they used to be able to, and I think it's a good point that we would be making that they ought to prepare for this, that they ought to build into whatever contractual funding arrangements are made the capability to put together something that at least passes as a public-use data file.

MS. BURWELL: It's my understanding that they are going to use the ad health-study model -

MR. HITCHCOCK: Yes.

MS. BURWELL: – for dissemination of public-use data, but, like Virginia said, I haven't heard any specifics worked out.

SPEAKER: What model did you say, Audrey?

MS. BURWELL: The adolescent health study that was conducted a few years back from the Carolina Population Center.

SPEAKER: Okay. Is that data easy to use?

MS. BURWELL: I have tried to use it, but -

SPEAKER: Is it as easy as any -

MS. BURWELL: Yes.

SPEAKER: Okay.

MS. BURWELL: They have a big public-distribution plan, and as far as the National Children's Study, in some ways, part of the problem is that it is so big and there are so many things that have to be attended to that it is hard to get a sense of what any particular - or even for the people who are renting it to focus on one aspect of this, such as data release, which is going to come fairly far down the road, but maybe the kind of thing that we can ask for is some assurances or an outline of a plan or just really emphasize the need to come up with a plan well before the data are at the point where they could be distributed.

DR. MAYS: Now, does that address your concern? Would that address your concern, Virginia, or does it run deeper?

DR. CAIN: I have many concerns.

DR. MAYS: Well, no, no, no, but you expressed that you - you thought that there were some questions that were being neglected in this data set because we have already answered them for the general population, perhaps, but in this data set, we could answer them for targeted populations that we haven't been able to answer them before. That was my understanding of the concern you expressed.

DR. CAIN: Well, yes, that is certainly one of my concerns. I mean, I also think that even - regardless of the targeted-population issue, to do something of this magnitude and not include or ensure that there is adequate collection on kind of the basic context that kids are growing up in would really not be - end up with a not very useful data set that you might get. You would get things like exposures to particular chemicals, but that is a very narrow range of what is effecting the daily lives of kids.

DR. MAYS: Well, what about - I mean, we have here explore the complexity of race and ethnicity and the interaction of the environments where people live and the impact on health disparities and health outcomes -

SPEAKER: Is that two bullets or one? Should it be.

DR. MAYS: Oh, should it be. Maybe it should be two. Explore the complexity of race, ethnicity and the interaction in the environments where people live.

SPEAKER: Maybe physical and social environments.

DR. MAYS: And action of the – okay. Let's -

SPEAKER: Is there a list of those hypotheses that are being honed in on right now?

SPEAKER: I think it's probably on their web site. I don't have the list right now.

SPEAKER: But isn't it -

MS. BURWELL: On the portal it's – 144 hypotheses. Some have been adopted and some have not. So they are in various stages, and that's on their portal, not exactly the public website.

DR. MAYS: I was just going to say, I don't think that we all can get to them. It has to be someone who has access.

SPEAKER: My problem with this survey is that it kind of doesn't – it's kind of like Jell-o. It moves around, and it's hard to get your arms around, because it hasn't formed enough for you to say this isn't enough in this area.

So I think the committee would be much more effective if it had something - if it were ready to reply in that critical period when there is something being decided before it gets solidified, but there's something there to talk about. Because all this stuff where you bring it up - and everyone's bringing it up on this call – I know it's all been discussed, but it's been discussed with 3,000 other issues. Until certain basic things are - kind of come into some focus, it is really hard to know whether there'll be enough of any one kind of person to do any analysis on.

DR. MAYS: But do you think that the letter pushes them to come to some resolution? Because I agree with you is that things are fuzzy, but the problem is I can't see them taking a focus in which they are deciding these things. It's like the notion of how this occurs and you're going to come out with a scientifically-driven set of hypotheses is beyond me, because this is like a weird way to approach doing this. There's a lot of input, but I don't know in terms of decision making and tracking –

SPEAKER: I think that's kind of the issue. I don't have a problem with listing the things that are of interest to the committee, but then what? And maybe there needs to be more - if the committee wants to have a role, you know -

DR. MAYS: Well, maybe -

SPEAKER: - ask for the role, but I think if you just lift 15 things you would like to see, it almost - it dilutes all of them, because there are so many of them in there and you really need to kind of pound in one thing or figure out a way that when these decisions are made you are at the table making your point.

DR. MAYS: Yes, I think that is what we really need, and that is where it was getting fuzzy. Some people wanted to send it forth and it's like, well, here is what we have learned, and I guess I'm trying to say we need a response, but I don't understand structurally - because it seems vague to me - the ways in which to impact that group, other than to say we need a response, but how do we make sure that before these decisions are made we are able to weigh in?

SPEAKER: Well, one of the things that strikes me about the bullets here is that they are pretty general, and I think, from the point of view of this committee, they are very bottom-line concerns that almost - if we had our druthers, no survey should be - no large, national survey should be done without these things being taken into consideration.

DR. MAYS: Right.

SPEAKER: So - particularly no modern one that is going to be with us for 10 or 20 years, for goodness sake, and so these should be expressed as bottom-line concerns, perhaps, and then a request that there be representation from this committee on their committee, and then, after that, it is just force of personality. So, I mean, Vickie, do you want to get involved in this?

DR. MAYS: What I was trying to avoid is that, when we send something forth, that in order for it to happen that we actually have to do it, as opposed to there is some reporting mechanism where we are alerted to this occurring and then we keep commenting.

SPEAKER: Right.

DR. MAYS: I mean, normally, we would comment at the level of the Secretary, but we didn't think we needed to go that high. So, right now, we are saying - this to an institute director, and, Virginia, is that an effective way, if this goes before Duane Alexander, that he then understands that he should - the way in which to then involve us with the progress on the issues that we put on the table?

DR. CAIN: I mean, part of it is that this is - the process is not, as I can tell, the way would be run. I mean, there's - the decision-making board is a group of people with representatives from the three agencies, and the recommendations seem to go back and forth between that group and the steering committee, but I still think it's the coordinating committee that has the ultimate decision-making power.

Now, a letter to Duane, I think that he would assure you that all this is going to be taken care of, but what happens is this thing moves. I mean, a year ago, there had been no requirements that a core hypothesis had to be something that required that sample size. That is something that just came out of their last advisory committee meeting or their last – I can't remember what they call them -

DR. MAYS: – assembly.

DR. CAIN: So things change all the time, and they kind of evolve. If we could get a handle on it, we will be the only group that has done that.

SPEAKER: Is there a way we could do this in several phases, rather than thinking that one letter will do it, that we can send a letter, perhaps to the – is it the steering committee, I think you said?

DR. MAYS: I think there's - what? - a coordinating committee -

SPEAKER: Or whoever. Whatever -

DR. MAYS: I know. See, this is the problem. The management of this thing is like crazy.

SPEAKER: Well, anyway, we could send a letter - this initial letter - urging them that this is something that needs to be addressed in the planning, because I don't think we want to wait until something is done to respond to.

I think the idea that it is fuzzy is actually a good thing, because maybe we can help them focus, at least in terms of our needs, and then tell them that we would be happy to look at any response that they could send us as to how they plan to incorporate these issues or address these issues and we would be happy to look at it and advise them and help them with it as a committee, so that we could try to build the relationship between, not necessarily an individual, but the committee.

DR. MAYS: I like that.

SPEAKER: The subcommittee and them.

DR. MAYS: What do others think about that suggestion?

SPEAKER: I like it.

MR. LOCALIO: This is Russell. I have a question. Who on NCVHS participates in the - what you call the -

SPEAKER: Coordinating committee.

MR. LOCALIO: - coordinating committee of this survey?

SPEAKER: I don't think there's anyone - Jennifer?

MS. MADAN: Well, I keep forgetting which committee is which. We have someone on detail to NICHD, who is working on this, and I thought that either John Kiley - or is it Ken?

SPEAKER: Yes, Ken Showendorf(?).

MS. MADAN: Showendorf. Yes, he's working on it. He's detailed there, but he may be our person on that committee. You don't know if –

SPEAKER: - some CDC on the committee. There's Marsha –

MS. MADAN: Marsha Lynn.

SPEAKER: Right. Marsha Lynn, and I can't remember the other two people.

MS. MADAN: Yes, there's someone - yes, but I think they're with Ken. If that is the committee you're talking about, that is the committee that Ken is on. I've gone a couple of times when he couldn't a few years ago.

SPEAKER: Yes, and the name they have on the sampling, Randy -

MS. MADAN: Right.

SPEAKER: Well, the decision making is within the coordinating committee. There are three representatives from each of the agencies and they don't want anybody else on it.

MR. LOCALIO: The decision making is done by the coordinating committee, did you say?

SPEAKER: Right.

MR. LOCALIO: And that is composed of members from the three agencies and they don't want to have anybody else on it. Now, who are the three agencies?

SPEAKER: EPA, NIH –

MR. LOCALIO: EPA?

SPEAKER: And CDC.

SPEAKER: Right.

MR. LOCALIO: What is the third one? EPA, CDC and - no.

SPEAKER: EPA, NIH -

SPEAKER: NIH.

SPEAKER: – and CDC.

SPEAKER: Because it's NICHD and NICHS, right?

SPEAKER: Right.

SPEAKER: Is it EPA or NICHS?

SPEAKER: Both.

SPEAKER: EPA is the third agency. NICHS would be one of the NIH -

SPEAKER: NIH, right. And then CDC has several centers. So it's NCVHS and the Chronic Disease Center and the Birth Defects Center.

SPEAKER: For NIH, at least, is there one person from each institute or is there only one representative from NIH?

SPEAKER: Well, I'm trying to remember. There's certainly not one from each institute. Eatshy(?) is the person who kind of runs the whole thing and he's NIH, and then I think there's an NIHS representative. I'm trying to find the website right now, so I can get more specifics.

SPEAKER: But in terms of the decision making, the ICC is sort of like the -

DR. MAYS: Wait. Say what it is. These initials don't help. Say what ICC is.

SPEAKER: Interagency Coordinating Committee.

SPEAKER: This is the Interagency Coordinating Committee, and they are like the last layer of advice to Dr. Alexander, then he makes the decisions.

DR. MAYS: By himself?

SPEAKER: Through all these layers of advice.

DR. MAYS: Oh, my -

SPEAKER: I mean, he relies on Keith(?) heavily and the recommendations of the coordinating committee. I mean, in some ways, I think he's a titular head more than an active participant in it.

MR. LOCALIO: One more question. Does the statute that authorizes this survey stipulate who has the authority to make these decisions? How did the Interagency Coordinating Committee get formed and get the authority to make recommendations, and how did Dr. Alexander get the authority to be the final arbiter of decision making?

SPEAKER: Russ, I sent you that legislation a little while ago.

MR. LOCALIO: Yes, I know, but that's a long time ago. I know I saw that. It was only a little tiny short piece.

SPEAKER: And that doesn't get as specific as to what you're asking. It usually says the Secretary through, you know.

MR. LOCALIO: Okay. So it's the Secretary who is making all of these decisions.

SPEAKER: No, no.

SPEAKER: - an agreement between the Secretary and the EPA Administrator. That's a long time ago, and that's the way it started, and then it got into legislation where they put it in NICHD, but it is supposedly a joint project, and I would - you know, I agree. I think - it may be because it's in his budget, but I don't know if he would consider that he is sitting around making these final decisions, but -

SPEAKER: It seems to me that Peter is probably the most important decision maker in this project. Is that right?

SPEAKER: - certainly controls the purse strings, as I understand it, would that there were any.

SPEAKER: Right. But, in my office, the way it works - and I'm putting this out here as - maybe it doesn't work that way everywhere, but the person who is in charge of the project is the one who knows more about it than their boss, and they will make recommendations, and, usually, the boss will go ahead with it, maybe with some modifications, but that is usually how the decisions get made.

So it wouldn't be Dr. Alexander who is thinking through everything and making the recommendations. He would approve or modify the recommendations being made. Is that the way it happens in other agencies?

SPEAKER: I think, certainly, that that is true. On any particular controversial issue he would be more involved in the decision making, but on day-to-day - you know, what questions are going to be included in the survey, he is not going to get into that.

SPEAKER: Right.

SPEAKER: He wouldn't need to be involved at all in that. Okay.

SPEAKER: Right. Right.

SPEAKER: So, there, we're back to Peter.

DR. MAYS: But what I was surprised about were the questions that Peter couldn't answer, but yet there was quite a bit of activity in that area going on. So that was the only thing that's surprising to me.

SPEAKER: You know, one thing that strikes me is if we could have the ear of - you know, a direct communication with some member of the board who was sympathetic to our concerns and willing to listen to our suggestions for how to address those concerns, that might be what we need. I don't know who that person would be. I mean, I wasn't at the data committee meeting to know whether - you know, what Peter was like or if he seemed open to the questions, even though he couldn't answer them.

DR. MAYS: Well, I think it's a difference between do we want to do this informally or formally be on the record and be able to have a response back.

DR. HEURTIN-ROBERTS: Well, I think we want to do it formally, but I think informal actions to support our formal actions don't hurt.

DR. BREEN: I agree with Suzanne.

DR. MAYS: Okay. Nancy, I thought you were suggesting -

DR. BREEN: No, no, not at all.

DR. MAYS: I get it. I get it. Okay.

All right. Here is what I am going to suggest, which is let's try and see if we can get a letter, because - as kind of our formal response, and then work on the informal response. If we can get a letter that we are okay with, then this can - we can try and get this through the full committee tomorrow.

Now, Virginia, I want to ask, this issue about the core hypothesis, can you - and you said you had some other concerns, and I take it that your concern about the core hypothesis I don't think is in this letter, and it would be a question of making sure that it gets included.

The letter, as it stands - I'm hearing different things – that all these bullets may be too much or that we leave the bullets in. Let's decide what we want the letter to be, and then we can decide what we need to work on.

But before we do that, I want to make sure - Virginia, any other comments that you have about concerns? Because it may be that those concerns would change how we would write the letter. Do you have some others?

DR. CAIN: Well, I have many concerns about the whole study. (Laughter). Kind of – just the organization and how - the structure of how it is run and things like that. I'm not sure we can tackle that, but I think -

DR. MAYS: That has been my concern throughout, because it just – I think that that is part of the fuzziness is that how this thing is structured, even though it has all these committees, it's - in my opinion, it's very difficult to see how that leads to the best science, but I've said that several times. I decided that maybe that wasn't in our purview to tell them to restructure themselves. So I left it alone.

DR. CAIN: Exactly, but I think that two issues that really would be within our purview, of ones that had been raised, and, one, making sure that we get adequate data to answer questions within different racial and ethnic subgroups and bring up the question of the public use of the data set and how that would be worked out.

DR. MAYS: Okay. Okay. Let's talk about the structure of the letter. I would like to hear from those who think that maybe, at this stage, having these - I don't know, I guess maybe 15 bullets or so might not be the most effective way or that reducing the bullets might be more effective.

SPEAKER: I have a suggestion to kind of focus more on the big pictures in the letter and then put the bullets in an attachment, like more specific things of interest. So you don't lose them, but whoever is reading it is not going to drown in them.

DR. MAYS: Okay. What do others think?

SPEAKER: I think that's a good idea, making me wonder which ones would be the big ones and which ones would be the small ones, and I'm a little concerned that this has to be ready by this afternoon or tomorrow afternoon? When is it?

DR. MAYS: Well, I have to fly this afternoon, so, for my input, it would have to be either when I got there in the morning it was ready or as of maybe about three hours or so I'm out of here. So, I mean, it would be -

SPEAKER: But you wanted to present this to the subcommittee tomorrow afternoon, is that right?

DR. MAYS: To the full committee tomorrow, yes.

SPEAKER: Tomorrow at 8:30 or at 1:30?

MS. JACKSON: You're on at 1:30 for the - I'm sorry - 2:30.

DR. MAYS: I have 1:30.

MS. JACKSON: Oh, I'm sorry, 1:30 is the claims adjustment and then 2:30. So you've got a little time.

DR. MAYS: We're in the afternoon we're on.

MS. JACKSON: The afternoon.

SPEAKER: Well, so what are the bottom-line concerns that we would have? The public-use data set seems like it is an important one.

DR. MAYS: I think the - data set, the adequacy of the sample of racial and ethnic minorities. I think that the population health perspectives to examine - the third one, to examine relationships and interactions among environmental, social, psychological and biological factors in health disparities. Can I live without these other things?

SPEAKER: We can put them in the appendix.

MR. HITCHCOCK: I don't know if we actually need them in an appendix. I don't think I would go with 2, 3, 4, broad recommendations, and one of those might be the one - translation and -

SPEAKER: Is it the last two?

MR. HITCHCOCK: Yes, probably some combination of those two.

SPEAKER: That would be a fourth one that you would add to the important bullets?

MR. HITCHCOCK: I think so, yes.

SPEAKER: And then you would just not include the others at this point?

MR. HITCHCOCK: Yes.

DR. MAYS: Wait a minute. Dale, can you go through and then say which ones you're talking about? I didn't quite get it. The first one you were saying 2, 3, 4. I didn't know if you - I was trying to number these, and I realize you're actually just talking about the numbers you want to see. Can you go through and say which ones you're saying?

MR. HITCHCOCK: You asked me - My phone's cutting out a bit. What did you ask?

DR. MAYS: Oh, which ones are you saying should be in?

MR. HITCHCOCK: I'm talking about the public-use data files – issues. The one that you brought up as the third one about pulling together environmental sources.

SPEAKER: Population health perspectives?

MR. HITCHCOCK: Yes. And then the bicultural aspects of this.

SPEAKER: The fourth one he would add were the last two bullets combined.

DR. MAYS: Okay. So let's walk through in terms of what we have and say what we would just dump.

We would dump this issue about the definition of health disparities or should we talk about it in the letter itself or should we put it in an appendix? Just so that I understand, are we talking about that these four are in the letter and then we have an appendix or are we talking about that we just totally get rid of this other stuff?

MR. HITCHCOCK: We could put that as a sentence in the letter, I think.

DR. BREEN: Why don't we work on a sort of hypothetical that let's try it with the four bullets that you and Dale developed as the key ones, and then we could keep these others in reserve - you know, they would be in our notes - as possible things we might want to bring up as details later on? Because what we are hoping for is ongoing communication with this committee.

MR. HITCHCOCK: You're right, Nancy, and I think Peter is very willing to do that.

DR. MAYS: Okay. But let me just ask about one that I am concerned about, and that is this is an agency-wide problem, that is, the definition of health disparities. Do we need them to define health disparities?

SPEAKER: I think HHS is working on a definition of health disparities.

DR. MAYS: Oh?

SPEAKER: They are - working on it, right, Suzanne?

DR. HEURTIN-ROBERTS: What's that?

SPEAKER: They are.

DR. HEURTIN-ROBERTS: Yes, they are. I don't know where they are with that. I know NIH is participating in that, but I don't know where the process is right now.

DR. MAYS: But I guess I was speaking for - that really determines what they should be measuring.

SPEAKER: I think at this point, you're really concerned not so much about how you are going to describe the data once you get it, but that you - so that you can identify certain differences, however you - you may have to come down with how you are going to measure that, but I think, at this point, you are talking about design issues. I would focus this letter on design issues. That is what they are doing, and so I think if you say to them definition of disparity, they are not going to know what you are talking about.

I think you really need to - and when you talk about the group, you're really talking about sample sizes. You want them to get a large enough sample size so that you can pick up important differences and whether you are going to measure - however you are going to measure the disparity. I don't think you have to get into that in this letter. That may be something you want to talk to Peter about, but the real issue is sample size for me.

And I also think that number three may help address that, too, because we talk about environmental, social, psychological and biological factors, and I would add in there economic, and I think by doing that and having the bullet on racial, ethnic subgroups, then we are asking them to design a survey where people can examine health disparities regardless of how they might be defined for purposes of this study.

DR. MAYS: Okay. All right. So we are going to dump one, dump two. We just modified three to include economic.

MS. BURWELL: I need to ask a question. I'm sort of doing this - and they can edit on the computer now. So I was wondering if Dale or someone else is doing that so - to prepare the final letter, the final draft?

MR. HITCHCOCK: I haven't been doing it, no.

MS. BURWELL: Okay. Well, then, I'm going to try to follow what you're saying and do it.

SPEAKER: Is that Audrey?

MS. BURWELL: Yes.

SPEAKER: And just ask qualifying questions whenever necessary. Thank you.

MS. BURWELL: Okay. All right.

SPEAKER: Thank you much.

DR. MAYS: All right. So we've got - we are going to leave three the way it is.

It seems like we need not - whatever - four and five, including the sample, ensure that - we need maybe a new sentence here - I mean, a new bullet here - right? – rather than writing it the way it is. Something like ensure the sample size is sufficient to allow for the analysis and meaningful interpretation of data for geographically distinct and small racial and ethnic minority populations?

SPEAKER: I would say the analysis and robust estimates of.

DR. MAYS: Okay. Jennifer, does this get what you just said?

DR. HEURTIN-ROBERTS: Yes.

DR. MAYS: Assure that there is -

SPEAKER: And then you can jump to data, I think, in that second bullet, data for geographically distinct and small racial and ethnic minority populations.

DR. MAYS: Okay. So let me see if I have this correct now. Audrey, are you with me?

MS. BURWELL: Yes, I'm trying to catch up. So -

DR. MAYS: Okay. Ensure that there is sufficient, and then you want me to drop down to data.

SPEAKER: No, I would say ensure that the sample size is sufficient to allow for the analysis and robust estimate of - and then drop down to data.

MR. CURTAIN: Excuse me. This is Randy Curtain -

DR. MAYS: Hi.

SPEAKER: Hi, Randy.

MR. CURTAIN: I just want you to be aware of one very basic design issue that is being - is somewhat controversial, and that is the use of the term national in scope for this study, as opposed to a nationally-representative sample for this study, because one of the major controversies in the design is whether this should be viewed as the type of multi-site clinical study where the clinics are selected based upon their excellence and ability to carry out the study and they take their patients and enroll them in the study versus a national probability - and so there's issues of coverage and how - the geographic distribution that is all tied up in the controversy, the national probability design versus multi-centered clinical-trial-type design.

MR. HITCHCOCK: I was wondering about that -

SPEAKER: Have you decided?

MR. CURTAIN: That has not been decided. There is a workshop scheduled March 21^st, I believe, where there is going to be a presentation. I believe this is open to the public, but probably limited seating is available, but it is going to discuss the issues of probability versus non-probability sample, alternative design, put this before a group who is then going to make a recommendation back to Peter and then up to Duane on the overall design of this stuff, then you can tweak the design within that framework.

SPEAKER: And, you know, until the decision is made, almost everything else is up in the air, because you would do it so differently -

SPEAKER: Exactly.

SPEAKER: – until you do that.

And a little bit of background, there was a contract that NCVHS had awarded a couple of years ago to Weststat(?) to kind of go through some of these design options. I'm assuming, Randy, that that will be part of that workshop, but –

MR. CURTAIN: That report was not received very favorably by several people.

SPEAKER: They're not talking about it?

MR. CURTAIN: I don't know if they are going to make that particular output available to this group. They have Betel(?) as a contractor now, putting together a paper on design options which is using the Weststat report input into their report.

SPEAKER: What didn't they like about the report? I mean, if it's a long answer - Weststat usually does very good work.

MR. CURTAIN: Yes, I think there is a long answer to it, but the short answer is that there's statistical considerations and then other considerations involved in the design of the study in terms of the Centers for Excellence wanting to be fully participants in it and they might not necessarily feel like - go in there through a probability design. So there's some – hate to say political ramifications, but that's the term I would use.

SPEAKER: The Weststat report was really about statistical issues.

MR. CURTAIN: It was primarily statistical issues, and it didn't really address the pros and cons of - see, part of the intrinsic controversy here is that they are not producing national estimates - prevalent national estimates of conditions. They are looking for causal relationships in these data. They feel that they are intrinsically biological or could be modeled appropriately, so they're - now have to be concerned about how the sample is selected per se.

SPEAKER: And that has implications for the issues you are talking about, because if they are intrinsically biological, then the sample design may not need to be over sampled and you may not need to be making estimates. Those things are very basic.

MR. CURTAIN: Right, but, on the other hand, you have the social and behavioral sciences aspect of it, which may not have been heard well enough yet, that would say, well, you know, there's other sources of variation that have to be considered, and many are not, in terms of the biological concerns.

SPEAKER: So it's very complicated.

MR. CURTAIN: And part of it is the fact that they haven't really taken their core hypotheses and prioritized them to say - you know, because certain designs would be good for some and certain designs would be good for others, and they haven't prioritized those - yet.

SPEAKER: So would you be concerned with the bullet that is under discussion now, the geographically distinct? Do you think we should take that out for the moment?

MR. CURTAIN: Well, the question I would have to you is to interpret what you are doing in light of this controversy. If you do any probability design, that implies a certain geographic distribution. However, a lot of these hypotheses are related to environmental exposures which have different geographic gradients to it. A probability design for organo-phosphates is something different than palites(?) and things like that. So you have to be concerned - one of the design concerns is that there may be very small pockets of exposure, and a broad-based probability design may not pick up those pockets, because probably the selection is too small.

SPEAKER: But you do want robust estimates for small populations, don't you?

MR. CURTAIN: All right. Well, that could be interpreted two ways. Robust, in that a very design consistent needs probability design in order to ensure the robustness, and the other is that if they had a properly-specified model and had the - composed a variation delineated in a properly-specialized model that would provide the robustness. So you give them wiggle room there on terms of the design options. From a lot of social behavioral and health disparity context, you would probably factor in more of a probability design, because you can't - I mean, those occur at random throughout the population or very geographically related, and so you won't be able to address that.

SPEAKER: I think - if you really want to look at environmental exposures, where this started, you use a very, very different design than if you want to look at social, and if you're – and kind of generic development kind of issues.

You can overlay the social on the design that is going to be looking at exposures, but it is only going to be in that context. It's not going to be generalizable, and, at some point, this study is going to have to come down on what it is trying to maximize, and some people aren't going to be happy, and so the committee probably needs to think about what side of that argument they are on, and I don't know even - you know, I wasn't at the meeting where Peter talked, but I know enough of these issues – really make a seasoned recommendation about where - what you want this study to do. Perhaps after the workshop would be the time to make those recommendations.

DR. MAYS: The only reason we were really moving ahead is because, according to Peter, that if we wanted to have input that could help resolve this it needed to be sooner rather than later. So that was why, because we get more - I think we learn more as we have discussions with others than I think we did from Peter that day. That's why I was a little concerned that - you know, there's a fair amount of activity going on, but I just didn't get a sense of he was really presenting all of that and presenting the dilemma as we actually have come to learn about them.

I mean, this is a critical issue for the committee to think about, and that is kind of where you do land on this, whether if we are comfortable with the study being kind of biologically driven and then you derive what you derive from that versus ensuring that - you know - it's kind of on an equal footing in terms of like these kind of social behavioral issues.

You know, this design issue really - once that decision is made, you then have to work with how to maybe integrate those two perspectives, but one is going to dominate.

SPEAKER: Well, one of the things that maybe we need to bring in here is there's a fairly new area within social determinance that is trying to figure out what are the biological mechanisms that are linked between social determinance and physical outcome related to health, and stress is a leading contender, but there are other things, because environmental modification can change biology. It can even change genetic structure, and we don't know much about that and we would like to know a lot more about it, and this might be an opportunity to do that, but I think maybe social determinance and biology need to be more explicitly linked, but there is a possibility out there there are hypotheses and that that should be something that these data allow for testing of. Would that help, do you think?

SPEAKER: Well, I'm not sure. I mean, there is a gene environment interactions working work that is generating hypotheses and feeding them up through the system, but what I'm not sure is how - as are many of the other working groups, but it is not clear to me how the decision was - that is going to be made as to what surfaces as part of the core.

SPEAKER: So then maybe we should just focus on what social groups need to be part of the core and not - you know, with some specificity, but not enormous specificity. What do you think?

MR. LOCALIO: This is Russell. I just have a comment, and I am very happy that Randy is on the call, but, Randy, are you still on the call?

MR. CURTAIN: Yes, I am.

MR. LOCALIO: Well, the point you brought up is no secret, the controversy is no secret, but I am reading back from my notes of our meeting in November. On November 6^th, I have a note, how will NCVHS be included in the design process? And what I would say the letter should say to Dr. Alexander is just that: How will NCVHS be included in the design process?

What we are talking about now is specific issues that we can't really address because we don't have sufficient information about what is going on, and we are out of the design process, and I think the focus of the letter is we have these concerns and we want to be in the design process, and that is what I would recommend. So that would be much more of a blunt letter than I think you've got proposed here.

DR. MAYS: But the question is - let's make sure we don't create something we can't do. It's like being involved in the process, what - I mean, specifically, is it that we are now attending all the meetings? We're just another voice, yet the decision gets made at a very different level. We're advisory to the Secretary. So I think where our value lies is in our ability to not necessarily be fully in the process, but to be fully informed about the process in order to do what is our charge.

SPEAKER: Intervene when needed.

MR. LOCALIO: Well, I agree with that, but we need to say that then. If that is the point, we need to say it. How are we going to be included? What is the mechanism by which we are going to be included? You know, how are they going to put this together? Because from everything I have heard about this process, there is no - I don't think anybody has thought about NCVHS down there. I don't think they care, and -

DR. MAYS: Well, I don't think they knew about us either.

MR. LOCALIO: Pardon me?

DR. MAYS: I don't think Peter knew about NCVHS.

MR. LOCALIO: Sure. I would agree with you. So I think we have say, look, you have to consider these other issues and you have to consider that this committee exists and has this mandate, and so, I mean, the committee needs to be involved in the decision making.

DR. MAYS: Okay.

MR. LOCALIO: But, by the way, and that would also be in the decision making of this very fundamental distinction between whether this is going to be a longitudinal survey that is similar to other longitudinal surveys or whether this is going to be an elite medical-center-based study that is very similar to just a multi-center study that goes on in other endeavors, and that is a very fundamental distinction, and would you agree with that, Randy?

DR. MAYS: We do have people sitting on here who are wearing a different hat who are at the level of receiving this information, but what does the group think about making that request?

MR. HITCHCOCK: Well, let me just say one thing - this is Dale - that when I talked to Jim Scanlon very early on about this letter, the letter is fine, but he thought he also could handle it with a couple of phone calls. So we got to sort of keep that in mind. I mean, he probably could handle a couple of phone calls on sort of what Russ has been talking about, letting people know that there is a new CVHS, for instance, if they don't already know what it is that we do, and how can we best have regular input into the design of the study.

I mean, we go all the way from a long letter with a list of recommendations to the possible option of just having a phone call. I just wanted to point that out -

SPEAKER: Can we do both?

MR. HITCHCOCK: Excuse me?

SPEAKER: Can we do both, have the letter and the phone call?

MR. HITCHCOCK: With both.

DR. MAYS: Okay. I think - I wasn't aware. I think that is a good idea is that, if that is that informal that people were talking about that, if Jim could do that, then, you know, one becomes much more comfortable about shrinking down a letter. I mean, I'm in a different headset now if we are going to say that Jim will make these phone calls that I think we really do go down to our few bullets and drop everything else.

SPEAKER: Also, we might – I think Russ' idea was good, in general, but I think we have to come up with a specific way in which the committee would be participating on the committee or being informed or whatever, and that might be something that could be discussed on the phone and then written in a letter, a confirmatory letter, just as a followup, so that everything that needs to be on paper would be on paper.

DR. MAYS: Yes, I think that - yes, I think we have to have a discussion about that, probably with John Lumpkin and Jim and kind of move on from there with that. Is that what you think, Dale, about how to work with them at something that gets worked at?

MR. HITCHCOCK: Sure.

DR. LENGERICH: This is Gene.

I guess I would go back to Jennifer's comment also in that I could envision different mechanisms to work with that committee, depending upon which side of the coin they come down on of how the sample is drawn, and so - and I think that is the critical thing that we have to get across at this point, that we are probably in favor of some sort of population health sample design and that we need to be engaged in that kind of discussion first, and after that kind of issue is resolved, then we will be more clear about how and to what degree our involvement should look like.

DR. MAYS: I'm not sure that we are definitely 100 percent behind that design, because if it is population based, depending upon how it is structured, you could end up with very few racial, ethnic minority.

DR. LENGERICH: I didn't say population based. I said population health, and so I think that maybe that is the place where our discussion needs to happen. I think that you could still explore disparities with a population health approach.

DR. MAYS: Okay.

SPEAKER: I think we do need to emphasize that the social, the economic, the environmental context that we have discussed needs to really be made a part of it. This is much too large a project to focus only on the biological, I think. I think it would be such a wasted opportunity -

DR. LENGERICH: I agree.

SPEAKER: - to not consider -

DR. LENGERICH: I agree wholeheartedly. I think our point number three there sounds –

SPEAKER: Yes.

DR. LENGERICH: – somewhat like what we want to put forward and make sure that - for them to consider us as being supportive of it.

SPEAKER: Yes.

DR. MAYS: Yes, I think three is turning out to be our - it's almost like once you got that in place, a lot of other things -

SPEAKER: Right.

DR. MAYS: - do fall into place. So that is definite.

Let's revisit this sample size - while we have Randy on line - to make sure that we don't box ourselves in a corner with it.

DR. BREEN: I was also wondering, the people who are doing the gene-environment interaction, are they all geneticists or are they a combination of geneticists and social scientists? Who's - could you give us some sense of - Randy - of who is working on that subcommittee?

MR. CURTAIN: Unfortunately, I don't know anything about that one.

DR. BREEN: Okay.

DR. MAYS: Virginia might.

DR. CAIN(?): I have the list of people. I don't recognize the names, but I could read it very quickly, maybe other people would. Melissa Bondee, Arvinee – I'm sorry. I can't pronounce that name - Checkravartees, David Ditz, David Eaton, Sharon Cardia, Maximilian Nunkees, Andrew Alshands, Nate Rockman, Robert Wright, Molly Bray, Stephen Channock, Janice Dorman, David Hunter, Fred Ledley, Robert Nusbaum, Sonia Rasmussen and Shalom Wakholder(?).

SPEAKER: I know none of them.

SPEAKER: I think Shalom Wakholder works at NCI. He's a statistician.

MR. HITCHCOCK(?): Yes. He's a statistician at NCI. A couple of other ones are with the people at CDC, the labs at CDC.

SPEAKER: My guess is that there would be a good number of psychologists on that group, if they are looking at - is this biology -

DR. LENGERICH(?): I think one of the questions is how do they define environment.

SPEAKER: Yes.

DR. LENGERICH(?): Is it a purely toxicological definition or does it include the social environment, for example, as well?

SPEAKER: Right.

DR. MAYS: True.

I think that maybe some of these are things that - this is the informal work. For example, it would be useful to find out whether or not an effusion on these committees is necessary, because of the - as I understand it, the people that are on the committee - that much of this was driven by the cochairs which are from the institutes - I mean, represent the various institutes - CDC, EPA and NIH - and so a lot of the environmental - as I understand this - is really more a reflection of kind of the toxicologist approach as opposed to environment, the way that we might think of it more broadly, and so it may be that at the informal level that may be the opportunity to say this is a point at which to add some different people to these work groups.

DR. CAIN(?): Yes, now, I'm sorry, I left off the two cochairs. One was Jeffrey Murray, who is from Iowa, and the other is Paula Um(?) from CDC. I don't know if anyone knows them.

SPEAKER: Yes, Paula a little bit. I'm starting to work with her, but I don't know her well, but she's from their genetic - I don't know if it's this - division or what it is, but she has quite a good reputation, but I don't really know her work. So -

DR. MAYS: Okay. Okay -

SPEAKER: But that group is quite good.

DR. MAYS: Do we want to try and - let's see if we can try and finish the bullet that we were working on that Randy was just commenting on to make sure that we can capture - Audrey, can you read what we have?

Does Randy sit on that committee? I mean, is he a good liaison for us? Isn't Randy on detail? Randy, you tell us.

MR. CURTAIN: Well, I'm not on detail. I'm on sort of - I'm serving as an informal consultant to Peter on statistical issues, including design issues, and when the planning came up for the workshop on the sample design issues, I started sitting in on that workgroup. I don't think I'm formally a member of the workgroup, per se, but I show up a lot.

SPEAKER: And Peter asked you to join.

MR. CURTAIN: Peter - talking to Peter, he views me as a consultant to him in the program office on their decision making and how to structure the format of the workshop and what will be discussed there. I don't think I'm a member of the workshop. When they have a closed session, I do not participate in it.

SPEAKER: You certainly have his ear, though.

SPEAKER: The study-design working group?

MR. CURTAIN: I didn't hear the question.

SPEAKER: Are you talking about the study-design working group?

MR. CURTAIN: Well, the study working group is a larger group, and then a subset of that is a sample design working group that has just a few select members of it. I have never really understood totally the interface of these people. Some of them are working groups and some of them are also the interagency coordinating committee, and then there's this external review committee that provides input as well, where university people and other people sit on it.

DR. MAYS: Aren't they hiring a sampling person?

MR. CURTAIN: Well, I suggested that they do that.

DR. MAYS: Yes.

MR. CURTAIN: But, right now, they have a contract with Betel and they are having Betel pull in some consultants and put together some working papers on draft-design options, on recruitment and retention issues, estimation issues and various things like that, and these working papers will be presented at the March 21^st workshop.

SPEAKER: Is Ken on that, too?

MR. CURTAIN: Ken, he might be on the - he's not on the subgroup for the design, per se. He might be on the other study group, but because Ken works directly in Peter's office as well, it's hard to say who is on the group.

SPEAKER: I just pulled it up. Ken is the ICC liaison for the study design working group, and among the group members are a number of people that certainly I recognize - Ty Arbuckle, Colleen Boyle, Brenda Eskinozi, Lynn Goldman, John Tiley, Weez Math, Steven Redd, Ink Spicer, Ira Tager, Jeanette Thomas, Gertrude Berkowitz, Onus Ellenberg, Fran Ferstenburg, Elaine Cullen Hubel, John Lynch, Gregory Pavlov, Paul Sorley, Mervin Susser, Mary Jane Teeta and David Williams(?).

MR. CURTAIN: And then the sample design is a smaller group within that. I don't think it's listed anywhere, but it has Jonas Ellenberg, Frank Spizer, the guy from Chicago – I forget his name, Bob something – the guy from Emery University and somebody from EPA on it. So it's a smaller group that's a subset of that group.

SPEAKER: Well, now, are you talking about Bob Michael?

MR. CURTAIN: Yes, Bob Michael.

SPEAKER: He's on the advisory committee. He's not on the working group.

MR. CURTAIN: Right. But he's also on this little subgroup that is looking at the design of this workshop on the sampling issues.

DR. MAYS: What is interesting is even in that list, I recognize few of those people who have expertise relative to racial and ethnic minority groups.

SPEAKER: Well, David Williams is the only name I recognized on that score, though there were some other people who do good work at population health.

DR. MAYS: Right.

SPEAKER: John Lynch, a couple of other people.

DR. MAYS: Right. And then you have to make sure that David - he's on lots of things right now -

SPEAKER: Yes.

DR. MAYS: - whether - you know, if he misses a meeting, we miss the issue.

So okay. I think we are learning a lot right now which is useful, but I think we have to decide what we want to do, whether to proceed with the letter, whether to wait and do this at another time or to have the letter and also the informal process that we talked about - what would you like? I'd like to get us - if we are going to do this letter, I would like to get it finished, so that we can actually present it tomorrow.

SPEAKER: I think both the letter and the informal process, because the response that we will get to the letter will be a formal response, but I think that since our discussion today has really shown how much goes on at an informal level and how much goes on very rapidly and things change and it's - you just have to have more of that informal contact to be able to - a handle on what is going on.

DR. MAYS: Now, how can we achieve this informal contact? I mean, while Jim will talk about us being involved, as you can see, you need to be almost in the upper level of this to have the bigger picture, I mean, because it is not being in one of these small work groups, and it's not attaching yourself to just one issue. I mean, our committee is concerned with several issues that cut across. So just so that we can offer Jim some idea of as he makes these calls what might work, what is your suggestion?

MR. HITCHCOCK: Yes, that's right. We need to do some - what I would think of as talking points with Jim - in addition to whatever else he wants to say he can make some of the points that we want to have made.

DR. MAYS: Right. So do you have a sense, in terms of this structure, the level of - at which we might best be informed? And it sounds like for sure it has something to do with the ICC.

SPEAKER: Yes, and it has - and Peter, as sort of the chair - I mean, he - it's a group of equals, but he is a little more equal than the others, just because that is where the money is going, but he really tries to have it a group decision-making process. So I think Peter is probably the best contact for that.

DR. MAYS: Okay. Can you tell me where you participate, and, Jennifer, where you participate? So that we have a sense of also the sources of information that we might be able to get as input into the committee?

SPEAKER: Well, I work with NIH staff who sit on the various working groups, and I have staff that attend - I occasionally meet with Peter, and I occasionally meet with the chair of the advisory committee who is Don Madison, but, again, it is very informal. I have gone to the coordinating committee meetings in the past from time to time, but it is not a regular involvement in decision making, by any means.

MS. MADAN(?): I kind of do my best not to go to any of those meetings, after having gone to a lot of them early on.

SPEAKER: (Laughter). I like that.

MS. MADAN(?): Well, I would like to - we could make a bet on what happens at the end of this, but I'm a little cynical maybe.

I do talk to Ken from time to time about what is happening, and John, but, generally, when they think there is something that is an NCVHS issue.

I have kind of been waiting for a recommendation that you can talk about as opposed to - at this point, everything is let's look at all of the possibilities, and that's fine, but, at some point, when there is really some proposal, I think that is when we might - as an agency - get more involved.

SPEAKER: That is one of my concerns. One of my issues with this is that I am afraid - if you get involved in the beginning or even at this point in time, it can consume all of your time, and, yet, if you're not involved, I'm afraid that things will become cast in stone and then it would be hard to change them.

DR. MAYS: Um-hum. I think that's been my concern, too, is that it kind of looks from the outside like there's not much going on, but, then, you talk to some people, there is – you know, some people are on a very steady path to make sure that certain things are being woven into the core hypothesis. They're working at the structure. They're wanting to be in at the gate to make sure that once this process is out for bid that they are going to be there. So there is a lot of activity, but, at the same time, it's like it seems to change every week.

SPEAKER: Some of these issues are not going to be - are not science issues. There's many different designs, many different ways to do this, and it would be very defensible scientifically. Some of them are more policy, and someone is going to have to make those decisions.

I think that NCVHS has - that is where their input is most useful, not in these day-to-day stuff, because, as you say, changes all the time and it is going to be very much a function of some of these major decisions.

Clearly, there are folks out there who have a lot of vested interest in how this goes, and that is understandable, and I'm sure they are spending a lot of time, but once those major decisions are made, other things tend to fall in place, and it's not so clear how to best to do this.

DR. MAYS: Well, it sounds like, at least at this point, what we would want to do is to be on the radar screen, and being on the radar screen is we send the letter and then we let Jim make some phone calls on our behalf, and maybe from there the strategy is to see where we can best have input, and if both you and Virginia and whoever is aware that we then kind of have a more formalized relationship that we can offer comments on, then you can also let us know about issues that we should respond to, as well as in our formal role we might be able to get access to those issues. Does that sound like it might work or do we need something else?

SPEAKER: No, I think that's worth a try. That's a good place to start.

DR. MAYS: Yes. Okay.

All right. So let's see if we can get our four points. We'll drop everything else. We won't have an appendix.

And I think, Dale, based on the conversation we have had on this issue that will be helpful to transmit to Jim, so that he knows kind of what our concerns are, how we want to be positioned and to see what he can work out for us formally.

MR. HITCHCOCK: Yes, okay.

DR. MAYS: Okay?

All right. Let's do this - the sample. Audrey, can you read where we are with this? And then let's see what we need to change.

MS. BURWELL: Ensure that sample size is sufficient to allow for the analysis and robust estimates of data, and then that's where we stop.

DR. MAYS: Randy, you had a - we were just at that point and we stopped, and your concern was that we not box ourselves into having this be kind of nationally-represented data. Is that - did I get it correct? Is that what you were concerned about?

MR. CURTAIN: Even though the national probability sample is best for some types of studies, this is also a longitudinal study, and one of the major considerations here is the recruitment and retention problem, and the ability to, first of all, enroll people in the study and then maintain them in the study over 20 years. So that is a major issue. The cost of a probability versus a multi-centered clinical is a major consideration, and some of the measurement issues kind of preclude doing truly probability-based scattered throughout the country. It would have to be kind of clustered within a clinic study and to collect the biological samples. So you don't want to come too hard on either - at this point. That is the purpose of this working group is to sort of delineate the advantages and disadvantages of the different survey designs and what can be done and what can be excluded under each design.

I think what you probably want to do is - what your emphasis as a committee would be, in terms of the data, the types of data, the distribution by race, ethnicity and the need to cover - I don't know if you want to use the catch phrase No Child Left Behind – (laughter) - but you could certainly consider that, that you don't want to exclude a large proportion of the four million births(?) by just dividing it into 30 clinics, unless there was overriding concerns that drove in that direction.

So this robust estimate is a nebulous enough term that it could be interpreted in several ways, but to the statisticians dealing with this, that would mean either a design-consistent, robust-model-based or a model-consistent design robust-based item. So you haven't excluded anything, but you put in your emphasis for the environmental and social factors and geography as well.

MR. HITCHCOCK(?): So it's more a question of adequate statistical power than it is national estimates, because it sounds more and more like it probably wouldn't - and when I hear estimates, I'm thinking of national estimates, and I'm not even sure what these - could produce estimates. I don't know whether it would be their area - or whatever or - I mean, do we want to move away from saying estimates entirely?

MR. CURTAIN: Well, I know the emphasis of most of the people dealing with the study is on causal relationships - and, like I say, national in scope, as opposed to be nationally representative.

The real issue is, if you are doing a causal relationship, are you dealing with all of the factors involved in that relationship, including the race, ethnic distribution, social factors, geographic distributions and environmental exposures and things like that. So the terminal bust(?) estimation still holds within the context of causal inference.

DR. MAYS: Could we say something like ensure there is sufficient sample size for analysis of causal relationships that can include geographically distinct and small racial and ethnic populations?

MR. CURTAIN: You can certainly put that in there. Again, once you get into the final design phase, the final decision making, there are going to be tradeoffs, and one of the tradeoffs you always get in a national design sometimes is geography versus sub-domains. You often can't do both in a design. At least in this case you have 100,000 children being entered in, which is a substantial sample size, but one of the reasons for that substantial sample size is they are estimating things at one- and two-percent prevalence.

DR. MAYS: Exactly.

MR. CURTAIN: And if you are at those rare conditions, you might be able to do it across the 100,000, but can you do it by sub-domains within that 100,000? And I don't think any design is going to be able to give you too much level of detail on a 0.5-percent statistic by five sub-domains.

DR. MAYS: Point well taken. I think that what we are trying to do is emphasize that, as these decisions are made, that what is important to us - it goes back to almost the first one - that is, the population-health approach - and that it is within the context of these relationships that we talked about, but in this one what we are trying to say is that our hope is that the sample size is going to be sufficient to ensure that we are going to be able to have some comment about these relationships in these specific groups, because if we - you know, I'm not sure exactly. If we just kind of leave it, the concern is always that we end up with black, white differences, maybe black, white, Latino differences, and then that is about the end of it.

SPEAKER: I guess my concern is that these issues - that they really do have to have 100,000 people to study some chemical exposure that is not very common or schizophrenia or I guess some of the less-wide-spread health issues that they want to look at. They may really only be able to get fairly narrow - or the racial and ethnic groups, they may not be able to have the diversity that they would like to see, but I think it is one of the more basic issues. We don't have the answers to those questions about family context, neighborhood context for some of the racial and ethnic groups. Whereas, you wouldn't need the 100,000 just to look at that. If you are going to look at the major groups, you certainly need that if you want to try and look at some of the smaller groups. So even on more basic questions, we really don't have those answers.

SPEAKER: Well, on those questions, we don't have the health outcomes associated with them, but we do, from the Census, have some information about household structure and some of the things that you mentioned -

SPEAKER: We do have some of them. We do - but in relation to health, I don't think that we have, and I don't think that we have them for as many groups as we would like to see, and this would be an opportunity to get -

DR. MAYS: Okay. How would you like to express this in a letter?

SPEAKER: (Laughter).

DR. MAYS: Concerns are there, but we gotta bite the bullet -

MR. CURTAIN(?): I think you probably want something to the effect that you have concerns about the overall sample size and its distribution by geography and minority sub-domains, and you would like to see these issues addressed as part of the decision making in the sample design to see what core hypotheses can be examined in terms of health disparities for any given particular design.

SPEAKER: I think that's good - because this committee really should think about what the implications are going to be if this is a very targeted, center-based - because you may not be able to combine some of this stuff. You may only be able to look at this within each of these areas. May be harder to - you know - what you're really going to be able to say for 100,000 kids may be - I think is still up in the air.

SPEAKER: I agree.

SPEAKER: These design issues are really going to be complicated, and the committee needs to decide what they want out of this. It's a lot of money, a big study, and there probably won't be another one.

SPEAKER: And unlike the big surveys that NCVHS does or the Census, this seems to be a hypothesis-driven survey, the kind that epidemiologists usually construct.

SPEAKER: It seems to be going that way.

DR. MAYS: Yes. So what – I think maybe the way to deal with this is to not try and make that a bullet, but to actually bring this up to someplace within the letter itself and to just say the committee has concerns about the overall sample size, specifically in terms of geographic distribution and overall sample size for racial and ethnic minorities, and that - again - what we would like is a consideration of these issues in any design that is considered by the study.

SPEAKER: Right. And it's not overall sample size. It's sample size for specific racial, ethnic, minority populations for whom we don't usually - we aren't usually able to measure anything in these surveys.

DR. MAYS: I don't know if we want that specific, because that is really hard then.

DR. BREEN: Well, but I don't think we just want to say overall sample size, do we? I don't think that conveys our meaning. Am I wrong about that?

SPEAKER: No, I agree, Nancy. I think that that is one of the basic issues we have always tackled, that these large samples don't provide adequate representation of some of the groups that we would like to have information on.

DR. MAYS: Do you want to specify what groups you are talking about, then?

SPEAKER: Well, if you use that one bullet that talks about Puerto Ricans and other island people, that brings it right down, and you might add Asians in, too, because those are the groups that typically don't get adequate sample.

SPEAKER: I think if you put that in the letter, it's going to kind of show your hand in a way about what you really want, and I don't know if you have really talked about what kind of design would give you that and what else you won't get because of the 100,000 births. If you really want to make those kind of estimates for those small groups, it is going to be a very different design and be very difficult to make any kind of combinations on. You would really need to have one of these centers, if it goes the center route, in an area. You would have to put it there, because that is the only way you are going to get it, and how that works with - you know, if this is a grand process or a cooperative agreement and - it gets very technical, I think, down the road, and if you really want to - I'm not sure you really want to say that, if this is the study where you really want to get those sub-populations.

SPEAKER: I think you have been in on most of the conversations where we have struggled with this issue, Jennifer, do you have any suggestions on how we might get the point across without being so specific?

MS. MADAN: I think what Randy suggested is good for this letter, because this isn't the final word. You know, you are going to get a formal response to this letter, and it's going to be more this is a door-opening letter, and if Jim makes his phone calls – because these are complex issues, and I don't think you can deal with it in a bullet - I would just raise the issue of - generally, of how race, ethnic groups are going to be dealt with in this design, and that you need to be at the table.

MR. LOCALIO: Yes, I want to reinforce that last point. You have to be at the table. These issues are very technical and complex, many, many tradeoffs, and we can't really – it is very difficult up front now to make these decisions. You have to kind of be there and participate in the decision-making process for these decisions to be educated.

DR. MAYS: Okay –

SPEAKER: So one of the things that is going to have to be discussed on these phone calls is how to be part of the process.

MR. HITCHCOCK(?): Yes, keeping in mind that we really are an advisory - because the Secretary, you know, does not make us - equals. I don't know. I'm thinking - want to be as much at the table as - to invite representatives of this study come to our table.

MR. LOCALIO: Before they make any decision that can't be revisited.

MR. HITCHCOCK(?): Sure.

MS. MADAN: Yes, I think you want to be involved in the decision making, not in the development. I don't think you can be, as a group. It would be hard, because there are so many groups, there are so many people involved in this that it is just one more person, but if this is truly an advisory committee to the Secretary, then - and this is a big survey - then it should have some advisory capacity here.

MR. LOCALIO: And one more thing, Jennifer, I would hate to have to see this survey take even more money away from NCVHS. I mean, that is what we don't want to have happen.

MS. MADAN: Thank you.

(Laughter).

SPEAKER: Is that at risk? Is that a possibility?

MS. MADAN: I have no idea.

SPEAKER: Because I thought this was pretty much funded by those agencies that were mentioned.

SPEAKER: No, the official position is that it can't happen unless this congressional appropriation -

MS. MADAN(?): Exactly. So - and congressional appropriation, health is only going to get so much.

SPEAKER: So this study isn't funded.

MS. MADAN(?): No.

SPEAKER: No.

MS. MADAN(?): Not yet.

SPEAKER: Okay.

MS. MADAN(?): I don't think it's going to take it out of our budget, but if there is - you know, how much more money is there going to be? And if you want, as Randy says, estimates for Populations, which you are not going to get from this, you could get from some other study, whether it's one we do or someone else does, you know, it is competition.

DR. MAYS: Okay. Let's go to second page of the letter, the first paragraph, where it talks about the NCS study as shared by - and what we do is talk about the kinds of things that we are concerned about, that these include, but are not limited to da, da, da, da, da, da, da, and it might be after that sentence that we say something in particular about the committee finds itself particularly concerned about the sample size - let me see. What did I do in my notes here? Scratched them out a couple of times. I want to capture what Randy said here, but before the sentence on guided by our hearings, maybe we can say something about the committee is particularly concerned about an overall sample size - oh, we don't want overall. I forgot. Is concerned about a sample size -

MR. HITCHCOCK: I used the word design.

DR. MAYS: I'm sorry?

MR. HITCHCOCK: Is it size that we are concerned about or the design that we are concerned about?

MR. CURTAIN: I think what you are concerned about is the sample distribution.

MR. HITCHCOCK: Yes.

SPEAKER: Thank you.

MR. CURTAIN: Given a sample size, how it is distributed across different characteristics.

MR. HITCHCOCK: Very good.

DR. MAYS: Okay. So the percent will be the committee is concerned about the distribution -

MR. HITCHCOCK: Distribution.

DR. MAYS: - of the sample.

MR. HITCHCOCK: Distribution of sample, I guess.

DR. MAYS: Distribution of sample across - how do we want to do this?

SPEAKER: Racial, ethnic and socio-economic characteristics?

MR. HITCHCOCK: And geographic domains -

DR. MAYS: The racial, ethnic, geographic and what else?

SPEAKER: Socio-economic.

DR. MAYS: And socio-economic characteristics.

MR. HITCHCOCK: Geographic sub-domains.

DR. MAYS: Geographic sub-domains?

MR. HITCHCOCK: Yes.

MR. CURTAIN: I wouldn't start mixing characteristics with sub-domains. Use one term or the other.

MR. HITCHCOCK: Why? Because they are sort of competing -

MR. CURTAIN: Yes, it's just a translation that you wanted to - for whoever is reading the letter, you know -

SPEAKER: How would you put it, Randy?

MR. CURTAIN: I would like to say the - by different types of characteristics, including the race and ethnic composition, the geographic distribution and the socio-economic status of the study participants.

DR. GREENBERG: This is Marjorie. I'm really sorry to interrupt.

SPEAKER: Hello, Marjorie.

DR. GREENBERG: Hi. I'm also sorry I couldn't be in two places at once. I still haven't figured that one out yet.

SPEAKER: Cloning.

DR. GREENBERG: There was a discussion going on upstairs that I really needed to contribute to as well, but I don't want to interrupt you while you are working on this letter. How much longer are you planning to be on this call? Because I understand there are some issues you wanted to discuss with me, and I'm happy to respond to them, but I don't want to barge in here, but this was - I got this little opportunity to come down.

DR. MAYS: Well, what I would like to do is to see if we can finish this up in the next 30 minutes or less.

DR. GREENBERG: The next what?

DR. MAYS: Thirty minutes or less.

DR. GREENBERG: Okay.

DR. BREEN: Vickie, I'm going to have to go at noon. I just wanted to let you know.

DR. MAYS: I'm sorry?

DR. BREEN: I'm going to have to go - this is Nancy - at noon. I just wanted to let you know.

DR. MAYS: Okay. All right. Let's see if we can finish the letter then.

MR. CURTAIN: I think the main point of the letter is just getting the basic point across, and then you can rely upon the telephone conversations to further illuminate the points and what you really mean by it.

DR. MAYS: Yes.

Okay. So let me see if I can do this and do this efficiently. The committee is concerned about -

MS. BURWELL: The distribution sample.

DR. MAYS: - about the sample. No, that's not the word I started to -

SPEAKER: The distribution, sample distribution.

DR. MAYS: The committee is concerned about the sample distribution by different characteristics - concerned about -

SPEAKER: Randy had the wording, if he could repeat it.

DR. MAYS: Yes, he had sample -

MS. BURWELL: Let me read what he said.

DR. MAYS: - by different characteristics, racial, ethnic distribution, but I don't have at the beginning of the sentence -

MS. BURWELL: Hold on a sec.

DR. MAYS: – different characteristics.

MS. BURWELL: The last sentence that I - when Randy was talking, it says, the committee is concerned about the distribution of sample across different types of characteristics, and then by race, ethnicity, social, economic status, geography, and then that's where we stopped.

DR. MAYS: What else?

MR. HITCHCOCK(?): Did he say sample? I forget - I can't remember.

DR. MAYS: Yes, he did say something about sample -

SPEAKER: Study participants, I think he said.

MS. BURWELL: Study participants?

SPEAKER: I think so.

MS. BURWELL: Okay. Of study participants. So then I heard him say something about -

MR. CURTAIN: Yes, I prefer to use the term study participants, because it gets away from that probability sample versus the clinic-based sample.

DR. MAYS: Good.

Okay. Read the sentence, Audrey. Let's see if we can get it.

MS. BURWELL: All right. The committee is concerned about a distribution of sample across different types of characteristics by race, ethnicity, social, economic status and geography of study participants.

DR. MAYS: Okay.

MR. HITCHCOCK: - was saying distribution of study participants by those characteristics, and did not say anything about sample.

MR. CURTAIN: Right.

DR. MAYS: Randy, can you run your comment again?

DR. GREENBERG: I'm going to have to go. Bye-bye.

DR. MAYS: - sample in terms of different characteristics, and then it was racial, ethnic distribution, geographic. I mean, I'm one that does not do wordsmithing well -

SPEAKER: I thought it was something like the distribution of study participants across characteristics of race, ethnicity, geography and I forget what the other things on the list were.

MR. CURTAIN: I think you need a second sentence as well to tie in what you mean by that, but the first study would basically introduce the concept that you are concerned about the distribution of study participants - distribute or however the words - the characteristics of SES, race, ethnicity.

DR. MAYS: Right.

MR. CURTAIN: And that introduces - since you have a concern, I think you need a second sentence to say exactly what your concern is and that is the ability to do causal inference so that the core hypotheses are related to those characteristics of importance. So you want to tie in the fact that these characteristics are related to the core hypotheses and are intrinsically part of the core hypotheses.

MR. LOCALIO: Randy, you want to get the message across that the association between some environmental exposure and outcome is influenced by somebody's geography, SES, ethnic background. Is that correct?

MR. CURTAIN: Right.

MR. LOCALIO: Yes. Okay.

DR. MAYS: Okay. I do not believe that it is in our best interest to try and wordsmith this right now on the phone as much as we need to get it written down, then work on it or else we are going to do this for like 45 minutes, and I've heard from you all now several times and you don't think that is the best use of your time to get the wordsmith on when our face-to-face meetings are on the phone.

So, Audrey, maybe while we're talking you can give us the sentences, and then we'll revisit them at the end, and then we'll make our corrections, because I think, without a specific thing to respond to, I'm just concerned we'll not be able to do this.

MS. BURWELL: Okay.

DR. MAYS: Okay?

And then, let's see, there's - what were the four things? The population perspective - we have that in - the sample size. The last two, which are concerned - something about the language - we have translate instruments into all languages necessary for the broadest participation of racial and ethnic subgroups in the study. Use bilingual and bicultural interviewers where appropriate. Do we still want that?

MR. HITCHCOCK: I'm willing to drop that out of the letter and have it be part of a phone conversation.

DR. MAYS: I agree. I was just going to say I think the informal - that that may be for informal.

And what else did we want in as kind of a fourth point?

MR. BURWELL: Public-use data.

DR. MAYS: Yes, public-use data. How about something as simple as assurances or outline of a plan for public-data use?

SPEAKER: Sure. That sounds good.

DR. MAYS: Okay. So that'll be - we can have that as -

MR. LOCALIO: I would expand that to - broad access to the data, because we are not just talking about a public-use -

DR. MAYS: Oh, yes -

MR. LOCALIO: We are talking about something much more than that.

DR. MAYS: Assurances or outline of a plan for public-data use which is broad in its accessibility and easy in its access. How's that? Oh - which is -

SPEAKER: How about which is broadly accessible.

DR. MAYS: Thank you.

SPEAKER: Okay.

DR. MAYS: Which is broadly -

MR. CURTAIN(?): And timely accessible?

DR. MAYS: I'm sorry, and what?

MR. CURTAIN(?): And timely.

MR. HITCHCOCK(?): That's a good one.

DR. MAYS: Okay.

SPEAKER: Time and broadly accessible.

DR. MAYS: Okay. Timely and broadly accessible. Okay. So we have that one. All right. So that is our four points.

So how do we end up? It says, currently, the NCVHS remains committed to the importance of da, da, da, da, da. We will follow with great interest.

We need to ask for something specific. I think Marjorie gave us a little specific language - get Marjorie's letter. Marjorie, are you on the line?

SPEAKER: Marjorie had to go back to the meeting.

DR. MAYS: Oh, okay.

MR. HITCHCOCK(?): Russ gave us - Russ talked about this, too. Russ, do you have some thoughts on this?

MR. LOCALIO: I don't have anything in front of me.

MR. HITCHCOCK(?): Okay.

DR. MAYS: Okay. Let me go to Marjorie's letter and - the NCVHS would appreciate feedback on these issues and welcomes continuing dialogue with the Subcommittee on Populations on how these issues might be addressed. The NCVHS remains committed, and then da, da, da, da, da. So she asks very specifically for feedback and continuing dialogue of how the issues might be addressed.

MS. BURWELL: Okay. You need to read that to me, so I can stick it in here.

DR. MAYS: I'll just send it to you. I mean, this is Marjorie's letter. So -

MS. BURWELL: Okay.

DR. MAYS: I just want to know from the committee if that is strong enough or they want something else -

MR. HITCHCOCK: Given that there'll be phone calls, I think it's strong enough. I don't think we want to be overly assertive on paper here.

DR. MAYS: Okay. All right. So I sent that to you, Audrey.

MS. BURWELL: Okay.

DR. MAYS: Okay. Anything else?

MS. BURWELL: The rest of the text you are leaving?

DR. MAYS: The rest of the text, meaning the beginning of the letter, the paragraph of the letter?

MS. BURWELL: The paragraph.

DR. MAYS: Yes.

MS. BURWELL: The paragraph. Okay.

DR. MAYS: And what we are dumping would be bullets, other than the four that we agreed upon.

MS. BURWELL: Okay. Now, there is the one that you talk about examine a causal relationship between social, economic and biological factors which contribute to health disparities and their impact on health outcome. That goes, too?

DR. MAYS: No, that's our first one, user population health perspective to identify and examine - that is the first one.

MS. BURWELL: All right.

DR. MAYS: Okay. What I'll do is - Audrey, if you can pull that together, why don't we send that to people as soon as you finish it, have them look at it and send the comments back to you and to Gracie, and, then, Gracie, if what you'll do is have them fax them to my hotel, and then when I get there today I can look at them, and then we can make sure we have a clean letter for in the morning.

MS. JACKSON: Audrey, are you at your office?

SPEAKER: Audrey's at home.

SPEAKER: Audrey's home.

MS. JACKSON: We are trying to work out the logistics. Maybe they can plug into a CDC line here at the Humphrey Building. Right now – generally, we're off line when we're in the meetings.

MS. WHITE: Because Dale is not here for his computer to be on.

MS. JACKSON: And you need something coordinated to -

DR. MAYS: Okay. Can we - let me finish with the committee and you all can do the logistics on the end of this. How's that? Because I've got people who are going to get off very soon.

MS. JACKSON: All right.

DR. MAYS: All right. Let me just look and see what else on here that we definitely need to do.

Can we get Marjorie back, Gracie?

MS. WHITE: I don't think so, Vickie.

DR. MAYS: Oh, I thought she -

MS. WHITE: I told her I'll try to set up something with you next week, maybe –

DR. MAYS: No, did Marjorie go back to the meeting?

MS. WHITE: Yes.

DR. MAYS: Can you ask her to come down?

MS. JACKSON: I did give her the - I prepared a spreadsheet, Vickie, based on the request that people were looking for, the various subcommittees, the number of meetings, the hearings, the cost for accommodations and speakers, things like that that you were looking for, and so she does have that request and she does know what the matters are.

DR. MAYS: Oh, okay. I thought, since she came down and she was asking us that we could talk with her, but that's okay.

Anything else that we want to bring up at this point? I mean, the only other thing that is on our agenda that we didn't really deal with, and I'm not sure that we should jump into it, is really to talk about where things were relative to the discussions in the San Francisco hearing. I think that is something we might be able to do at another time.

MS. JACKSON: Hi, this is Debbie. As well as status of any upcoming reports from the committee.

DR. MAYS: Any things we want to bring up now? Anything else?

MR. HITCHCOCK: I don't think of anything that we need to cover today, and my battery is starting to flash at me.

SPEAKER: Yes, I need to get going.

DR. MAYS: Yes, I figured we were hitting the magical hour here.

SPEAKER: Uh-huh.

DR. MAYS: I am absolutely very appreciative that you all were able to be on a call for this amount of time and that you have the stamina and endurance to do a telephone call for this - (laughter). I mean, I'm not - I go nuts -

SPEAKER: My ear is numb at this point.

DR. MAYS: I know.

So - Okay. I will be there tomorrow for the full committee meeting. We will try and get this letter approved and through.

And the other thing that I want to do is I will attempt to work with the staff on coming up with a work plan to kind of distribute and attend to all the things that we have on our plate, so that we can figure out how to get that done, and to look at who the additional staff are I think that also will be on board to work with us, as well as whether we have any new committee members.

So I think some time after the meeting, we will sit down as a group and do that, and then we'll be back to the full subcommittee.

Other than that, I think that's it.

MS. LUCAS(?): Excuse me, Vickie.

DR. MAYS: Yes.

MS. LUCAS(?): Hi, this is Jackie. I just wanted to let you know I've been on the call. I haven't said anything, but I have been here.

DR. MAYS: (Laughter). Well, thank you, Jackie.

Okay. All right. If there is nothing else, then I think we should be adjourned, and I will see you all in D.C. tomorrow.

(12:07 p.m.)

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