NCS Pre-proposal Conference 4 2 08 transcript.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL INSTITUTES OF HEALTH

EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH

AND DEVELOPMENT

NATIONAL CHILDREN’S STUDY

PRE-PROPOSAL CONFERENCE

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April 2, 2008

EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH

AND DEVELOPMENT

6100 Executive Blvd.

Rockville, MD

NATIONAL CHILDREN’S STUDY PRE-PROPOSAL CONFERENCE

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DR. JEFF EVANS: Good afternoon. I'm Jeff Evans, with the newly named

Eunice Kennedy Shriver National Institute of Child Health and Human Development. I'd like to welcome you today to the Pre-proposal conference for the National Children's

Study. I'll be your moderator today.

Let's briefly review the agenda of what's going to happen. I'm going to give you a little orientation to the technology that we're using today. After that we're going to have several technical presentations. We'll cover contracting issues, an overview of the study, and the technical requirements of the Study.

Now, I want to impress upon you that this is an interactive kind of capability.

So, at any time you can ask a question. And I'll show you how in a little bit. But if you already know how, you can go ask it now.

We will have a break, after the presentations, and we will tally up all the questions and try to get them into the hands of the people who will answer them. When we reconvene from the break, we'll take the questions one-by-one and answer them as fast as we can.

Some of you were good enough to send in questions before this webcast, and we've done our best to work them into our presentations. Some of the questions were so complicated that we're going to have to our homework. And, so, we'll have to get back to you through the formal procedures that we'll discuss later on. But for most general questions, we'll answer them today.

We will end promptly at 4:00 p.m. And at about 3:45 we will try to cutoff the questions so that we have a chance to answer the ones that we have.

So, that's our agenda. Let's get to know one another. First of all, as you can see on your screen, I am talking to you from the little box up on the left-hand corner. In the big box in front of you -- let me see if I can activate my pointer -- you can see that the formal slides will appear. And, incidentally, these slides will be available through the procedures that are described in the request for proposals (RFP). So, they'll be memorialized for all time, as will a transcript of this meeting.

The question-and-answer box is over below my talking head. And everything that you type in and ask us will appear in the question-and-answer box. And, incidentally, only you and I will see these questions. For those of you who are familiar

EAST- RFP NIH-NICHD-NCS-08-21E and WEST -RFP NIH-NICHD-NCS-08-21W with us you should know that we've transformed our fifth-floor conference room into a studio. And we have a whole team of experts ready to sort your questions and get them into the piles.

Now, how do you ask a question? Well, you use this box down here, this little rectangular box that is right here. Type in your organization name, your name, and the question. And we'll be able to keep them properly organized that way. And then when you're finished and you want to send it, you use this little icon here that symbolizes the return on the computer. And, incidentally, you can also use your computer's return, if you're old-fashioned. So, anyway, that's how we submit questions.

Now, let's warm up. I'm going to ask you a couple questions and just get a feel for who's out there. So, in which time zone are you located? So, if you would just vote -- the East Coast is winning. So, it's pretty much East and Central, a little Pacific.

No one from the Mountain? Okay. That's okay.

Next question I'd like to ask you is: Who's with you? Are you all alone or are you with a group of people? So, if you would, submit your answer there. Let's see.

Oh, a lot of singletons. Wow. Well, it's varying thing. All right. Oh, I see the rest of you are counting up your group. Oh, okay. Okay. So, it's -- most of you are all alone, but some of you are in fairly commodious groups. Thank you, very much.

Now, let's practice with the question capability. And actually we have a secret motive for this next question, because we want to develop an attendees list. So, if you would type in the name of your organization and a list of the people who are with you and send that to us, we will then have a list of who's attending the conference. And thank you. And you will now know how to work the software for this web-cast. And from this point on, please use that question box and send us your questions.

All right. Now, I would like to introduce several speakers who have technical presentations. The first thing we're going to do is talk about some contracting issues.

And I would like to invite Fred Ettehadieh to come up and tell us about the contract issues.

MR. ETTEHADIEH: Thanks. Welcome to the National Children's Study Pre-proposal Conference for the 2008 new centers RFPs. These are the numbers that you see on -- you should see on the slide on your monitors. These are the two RFPs that

EAST- RFP NIH-NICHD-NCS-08-21E and WEST -RFP NIH-NICHD-NCS-08-21W are, as you have seen them in the Federal Business Opportunities, where the RFPs are issued. Any amendments in the future to the RFPs will also appear on the same side, Federal Business Opportunities, FedBizOpps. I will have the link for the FedBizOpps available for you further down in my slides, which then you can; please bookmark it and have it available at all times during this acquisition period. I wanted to emphasize that all the information from this Pre-proposal conference will be available, will be issued on the FedBizOpps, probably by next week.

What I'm going to be covering today on my presentation are the point of contact for this acquisition, the purpose for the Pre-proposal conference, the acquisition schedule. It's very important for me to go over this with you, and as Dr. Evans was saying, this is an interactive. So, I want to make sure, if you have any questions concerning this matter, please address them to me at this time through the web link --through the questions that you can submit now or in the future.

The next thing is exchanges with offers before receipt of proposals, and then technical proposal page-limit requirements and business proposal instructions, and finally type of contract that we are going to be letting in the end of this acquisition period.

I wanted to make sure that this information is available to you now on my presentation. This information is available right now on the front page of the RFPs.

And I just wanted to make sure also I highlight them here. For the purpose of this acquisition, the primary point of contact is myself, Fred Ettehadieh, the contracting officer. My e-mail address is as is listed there and, of course, phone number. And the secondary point of contact is Ms. Elizabeth Osinski. And her e-mail address and phone number is listed there. This information -- again, I just want to emphasize, this information is also available on the front page of the request for proposals, which are on the Federal Business Opportunities website.

I also want to mention that, if you have any additional questions after the Pre-proposal conference, please submit them in writing by mail or e-mail and I ask you for your questions to be submitted and received by me at those e-mail addresses I've identified up on the -- above this, on the same page, no later than April 11, 2008.

This date is very important for you to -- I want you to understand this day is

EAST- RFP NIH-NICHD-NCS-08-21E and WEST -RFP NIH-NICHD-NCS-08-21W very important, because this will give us time to prepare responses to any concerns or questions that you may have. And also give us an opportunity to have an amendment to the RFP in a timely manner. So, please, I ask you to consider this very important date, April 11, 2008.

As I was mentioning just a few minutes ago, we are very glad that you are able to join us on the web and by telephone conferencing. We are very interested to provide you, the potential offerors, of a clear understanding of the requirements and also to make sure that you'll be able to judge whether you can fulfill the government's requirements. So, this is going to be supplemental information, in addition to the RFP.

My emphasis today, not only is going to be on all the presentations that you're going to be hearing, but I would like to really emphasize that, please -- one thing that I want to leave you with, please read the entire RFP packet. That's very important. We have all the information you would need for preparation of your proposals, your offer and how they are going to be evaluated.

One of the sections I would like to identify, Section L, which I would like to emphasize is the section that will provide you information on how your proposals should be prepared. That will cover the technical proposal, as well as the business proposals.

And also Section M, which is the evaluation factor for award – a very important section of the RFP. And, please, do not hesitate to have that information reviewed and available to you, because that's how your proposal will be evaluated.

There is a list of criteria there. Also there are scores that you -- that's how they will be judged by the technical evaluation panel.

So, hopefully by going through this Pre-proposal conference. You'll have a better understanding of the requirement. You'll have a better efficiency of preparing your proposals. And also, of course, we'll spend some time on responding to some general questions that have been submitted and also will be submitted throughout this conference.

As I was saying just a few minutes ago, the acquisition schedule, as you should be seeing it on your monitors, and it is presented in this slide, it's very important to understand that this information is available to you, again, on the RFP. And this is a general time line for planning purposes. So, I'm just going to go over it now and I'm

EAST- RFP NIH-NICHD-NCS-08-21E and WEST -RFP NIH-NICHD-NCS-08-21W going to identify some of them that I need you to respond some information to me when the time comes.

So the RFP was issued on March 19, 2008. Again, the RFP was issued in

Federal Business Opportunities, FedBizOpps. And I'll have a website for you in a couple of slides down in my presentation. There were two RFPs issued. And, as you recall, I have this set on the cover page of my slides. One RFP is for the West, and the other is for the East. And that's how they are posted. They're all the same.

As identified on the front page of the RFP, all question cutoff dates are April

11, 2008. That is in writing, by mail, or by e-mail. And that, again, as I mentioned, the point of contact, that's where the questions need to be submitted to.

The next item is the proposal intent response sheet, which is due by April 14, 2008. This information is part of the RFP, is one of the attachments of the RFP. I want to emphasize that this is information that you may start submitting now. There's point-of-contact information on those sheets. There are two sheets available on the RFP --on each of the RFPs. There's my fax number, my e-mail address, my point of contact on there.

This is some very important information, because we need this information to be able to start planning the proposal evaluation. This information that you're submitting is not binding; however, as I said, this will create a very efficient system for us to prepare the evaluation – the scientific evaluation process for your proposals.

A very important date is the proposal submission date, May 2, 2008 and that's the date for both of the proposals for the West and the East. That date is on the cover page of the RFP on FedBizOpps.

From here on down, this is how we are planning to move through the process of this acquisition. The contracts office will notify the offerors, whether they are in or out of the competitive range. We anticipate that the notifications will be accomplished through the month of July 2008.

During July and August 2008, we will start discussions, negotiations with the offerors in the competitive range. That is, we will submit technical and business questions in writing to the offerors in the competitive range.

And then the final proposal revision is due to us in August -- through August

EAST- RFP NIH-NICHD-NCS-08-21E and WEST -RFP NIH-NICHD-NCS-08-21W or September 2008, because we anticipate multiple awards of contracts in this fiscal year, which is September 2008. We anticipate September 26, 2008 as the contracts award date -- that's what we anticipate.

So, it's very important for us to convey this information to you. I have done that through my presentation today. Also the dates, March 19, April 11, April 14, May 2, those are all available on the RFP cover page and throughout the RFP, which is on

FedBizOpps.

I wanted to mention that the Government reserves the right to award a contract without discussions, if the contracting officer determines that the initial price is fair and reasonable, that these discussions are not necessary.

So, what I like to leave you with here is, the offerors’ initial proposal should contain their best term from a cost or price and technical standpoint.

On this slide, I've identified exchanges with offerors before receipt of proposals. Basically it's a ground rule to -- that I would like to go over for this acquisition, which started when the solicitation which was issued on March 19. This is a full-and-open competitive acquisition procurement. So, to avoid creating an unfair competitive advantage, the presentations that we are going to be providing today, the transcripts of this conference, as well as questions and answers will be issued as an amendment to the RFP, as soon as practicable after the conference. We should be issuing this information next week. So, please, I'd like to emphasize and I'd like to make sure this is completely clear, that this information will be issued on Federal Business

Opportunities, FedBizOpps. And on the bottom of this slide, I would like to point you to that URL to the website. Please have that information available to you, if you don't have it at this time. This is where we will have the amendments. This is where the RFP is now. This is the link for the Federal Business Opportunities. It is the responsibility of potential offerors to check this site to obtain communication regarding this solicitation.

The hint that I give you is, when you go to this site, you may register to get notifications. That way, when you register on this site you should be able to receive notification to an e-mail that you designate, when you register at this site. That way you don't have to check it that often.

So, the second bullet on this slide I wanted to emphasize that. As I

EAST- RFP NIH-NICHD-NCS-08-21E and WEST -RFP NIH-NICHD-NCS-08-21W mentioned, I am the primary point of contact for this acquisition. The contracting officer must be the focal point of any exchange with potential offerors. As I said, this is very important, because this is a competitive acquisition. So, please submit your correspondence directly to the point of contact information that you have.

Also, please identify the RFP number, the one that you have seen on my first slide, that of the West and the East, in your correspondence. That would be very helpful.

The remarks and explanation provided today do not qualify the terms of the

RFP. The information provided at this conference is for informational purposes. So, this is supplemental to the RFP only and does not override the terms of the RFP.

For any ambiguities or conflicting information, the offerors shall refer to the

RFP. And then it is very important for me to say this and make sure everybody understands, the changes resulting from the conference are official only if issued through an amendment to the RFP. And that's what we're planning to do. And any future amendments to RFP will be issued to the Federal Business Opportunities website. And that's the website that I wanted to leave you with.

As I mentioned, one of the items that I wanted to cover was technical proposal page-limit requirements. This information is identified in the RFP. One thing which was not in our RFP, which I'm identifying here, is the margins. And as several bullets down from the top in this slide, it says, margins must be set to one half inch on each edge of the paper. Hopefully that helps with some of the individuals who had questions about this.

So, starting from the top, the technical proposal is limited to 25 pages.

Attachments and other information, including resumes, data sharing plan, letters of commitment, human subject documentation, etc., are limited to an additional 75 pages.

The entire technical proposal is limited to 100 pages.

I want to make sure that I convey this message, that pages that exceed the page-limit requirements will not be read, evaluated, or considered for review. So, this very important for potential offerors to look at the page-limit requirement, which is addressed in the RFP. And then the paper size should be a standard, not to exceed 8.5 by 11 inches. The font size shall be no smaller than 11 point. Margins, as I said, half

EAST- RFP NIH-NICHD-NCS-08-21E and WEST -RFP NIH-NICHD-NCS-08-21W inch. And two-sided pages will count as two pages.

On the business proposal side of it, I'd like to say that offerors must submit a complete, separate business proposal for each Location proposed. And then there are templates for preparing your budgets, the budgets that you are submitting with your business proposals. There are templates available on the Section J of the RFP, which is attachment 24 of the RFP. And those are live -- if and when you go and pull this up, these are active links available there for you to upload this Excel spreadsheets that we are asking for you to submit when your proposals are arriving on May 2, 2008. And there's information about submission, and the number of copies, and the format, everything available in the package and the receipt of the RFPs.

And the next item is for assisting for preparation purposes -- I'd like to bring your attention to Section J, Attachment 9, titled, estimate of effort. This information is available to assist you in the preparation of your proposal. This information is for guidance only and is not to be considered restrictive for proposal purposes.

The other item is very important for any acquisition over $550,000. I'd like to make sure that the potential offerors are aware of this. And, again, this is identified throughout the RFP. And specifically Section J, Attachment 23 will provide an example of such a plan. The plan is titled, Small Business Subcontracting plan. So, any potential proposed contract or offer over $550,000, the offerors shall prepare a Small

Business Subcontracting plan.

Now, I want to make sure you are aware that this plan is not required to be submitted with your initial business proposal; however, this plan will be requested from the offerors who are in the competitive range. And I wanted to identify where in the

RFP this is available, which is in the Section L of the RFP, Item C, like cat, the letter C, Item 6. And there you will have the information of the U.S. Department of Health and

Human Services anticipated minimum subcontracting goals for this RFP.

What I'm trying to do now, I'm trying to just clarify that in our RFP there is a

Small Business Subcontracting plan. And also there is extent of small disadvantaged business plan. Those are two separate requirements in Section L of the RFP.

The first one, Small Business Subcontracting plan, shall not be submitted with your initial business proposal. However, the small disadvantaged business participation

EAST- RFP NIH-NICHD-NCS-08-21E and WEST -RFP NIH-NICHD-NCS-08-21W plan which is, again, on Section L, must be submitted with your business proposal.

The extent of small disadvantaged business participation plan is in Section L.

And I want to bring to your attention that that is in Section M, evaluation factors for award.

Type of Contract and number of awards – It is anticipated that multiple awards will be made form this RFP on/about September 26, 2008. It is anticipated the award from this RFP will be a multiple year cost reimbursement type completion contracts with a period of performance of five years, and incremental funding will be used. Unlike a grant, the individual cost categories may be shifted during the performance of a contract. So, you're not restricted to keeping the funds in one cost category. That's after the contract is awarded and during the performance of the contract. Thank you.

DR. JEFF EVANS: Thanks, Fred. That was Fred Ettehadieh. And next I'd like to invite Peter Scheidt, who is the Study Director. Dr. Scheidt is going to tell you all about the overview of the Study and introduce you to some of the technical people on staff.

DR. SCHEIDT: Good afternoon. And welcome to this Pre-proposal conference about the National Children's Study and the procurement for additional centers for the National Children's Study.

My role this afternoon is to orient and introduce the National Children's Study to those of you for whom this is a new undertaking and a new interest. In doing this, I will give a very brief overview and history of the Study and how it evolved, review with you the structure of the National Children's Study, how it's organized and its various components, I will point out the time line and the milestones of this Study, as it has come to this point. But most important of this entire afternoon, is the opportunity for you to ask questions and seek clarification of issues that you may have with the procurement.

The origins of the National Children's Study began with the response of the

President of the United States and the Administration to concerns during the 1980s and

1990s about increasing awareness of environmental exposures, and the risks of environmental exposure to children, and various diseases and conditions that children experience.

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In so doing, the President appointed a task force to develop national strategies to control environmental risks to children. This task force, titled the

President's Task Force on Environmental Health and Risks to Children, appointed in

1998, found that existing studies were far too limited to provide the needed answers.

And that a longitudinal Study designed to answer these important questions was needed. Such Study should be bold and identify effects to ensure safety of our children.

Following this in the fall of 2000, Congress authorized an NICHD to proceed with conducting a national longitudinal Study of environmental influences on children in the Children's Health Act of 2000. These acts point out that this Study was called for by national leaders, both in the Executive Branch and from Congress at the very origins of this Study.

Then, as the National Institute of Child Health and Human Development, and its sister lead agencies began to plan this Study, and as it's carried out to this day, the concepts of the Study are that it aims to identify the potential environmental effects that may be harmful to children or may not be harmful to children. It aims to identify, for those important conditions and diseases that children experience, the potential preventable causes. And in so doing, this Study aims to provide a valuable national resource for future studies for decades to come.

From it's very conception, this Study was envisioned and it was felt to be important that it be hypothesis driven, that it be concerned with exposures early in pregnancy and throughout pregnancy, and that it have the power to study important, even if infrequent, high-priority conditions that our children experience. Therefore, it must be large enough on the order of 100,000 participants, and must be able to study how genetic factors interact with environmental factors. As I have mentioned, it will provide a national resource for future studies.

The process of planning for the National Children's Study began with an Inter

Agency coordinating committee of the lead agencies, which consisted of the National

Institute of Child Health and Human Development, the National Institute of

Environmental Health Sciences, the Centers for Disease Control, and the

Environmental Protection Agency. And these agencies and senior scientists in these agencies continued to provide oversight and leadership at a high level for the National

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Children's Study.

The planning process included a Federally Chartered Advisory Committee that continues to provide on-going advice to the Study. Under that advisory committee were a number of working groups that focused on identifying important hypotheses and the associated measures and methodologies that would be needed to answer those hypotheses.

With this planning process, a series of workshops, of literature reviews, white papers, and pilot studies were undertaken. The reports of these planning activities are available on the National Children's Study website.

Since 2003, a staff of scientists and professionals in the NCS Program Office at NICHD have continued the planning and implementation of this Study , joined in 2005 with investigators from the various centers that have been participating in the National

Children's Study.

The hypothesis related priority health outcomes and exposures are far too many to address in this presentation, but they may be organized according to priority exposures and priority outcomes that give an overview of the span and scope of the issues that this Study addresses. Priority exposures include those of physical environment, of chemical exposures, biologic environment, such as infectious agents and nutrition genetic factors, psychosocial factors, such as family structure, and exposure to media and violence. All priority exposures aim to study how they may affect priority outcomes of pregnancy, of neurodevelopment and behavior of injury, and obesity, and growth, and development.

Early in the decision-making process of this Study, we confronted the decision of who would participate and what would be the sample of participants. Extensive deliberations and study concluded with the decision that a national probability sample was correct and important for the sample of the National Children's Study, in order that the exposure outcome relationships uncovered and identified by this Study apply to and reflect the experience of all the major groups of our children experience. That can only be done with a representative sample of US children.

In addition, it was recognized that the wide variety of exposures included in the National Children's Study are distributed differently throughout the population. In

EAST- RFP NIH-NICHD-NCS-08-21E and WEST -RFP NIH-NICHD-NCS-08-21W order to assure that key exposures are not missed, a representative sample is the best way to assure that all important exposures are captured.

In addition, in order to understand what happens in communities and neighborhoods, it was felt that a clustered-sampling design would be important, to be able to identify the attributes and characteristics of the community and to make the logistical implementation easier.

However, it was also felt that centers of excellence would be important to implement this Study. And that's why you are in the audience. We are seeking centers of excellence to help us carry out the Study in Locations that would be participating.

The centers of excellence are necessary for both scientific input for the engagement and identity with those communities that would be included, and to provide the expertise and facilities to carry out this complex Study. This strategy of a representative sample carried out by centers throughout the country is a unique combination that had not been undertaken on this scale before, and, indeed, requires considerable flexibility and adaptation of the centers to the scientific design. That is what this procurement and these procurements for centers to help us carry out this Study are all about.

In developing the sample, leading sampling statisticians at the National

Center for Health Statistics worked with the Program Office to actually develop the sample. Starting with all of the primary sampling units throughout the United States, consisting of 3,141 counties, representing all births in the country, from which 105

Locations as primary sampling units were selected as the National Children's Study first-stage sampling sample. From each of these primary sampling units, or counties, we call them Locations, neighborhoods will be selected as segments for the second stage of the sample. From each of these segments all or a significant portion of the households within these segments or neighborhoods will be invited to enroll in the

National Children's Study, when those households contain an eligible woman of child bearing age with some probability of becoming pregnant. That is the sample. The map of the Study Locations portrays the various stages in developing this sample that have taken place thus far. It's a little complicated, but when we walk -- briefly walk through it, you will see how this reflects the stages.

The orange dots, these are seven of them, are the Vanguard Locations that

EAST- RFP NIH-NICHD-NCS-08-21E and WEST -RFP NIH-NICHD-NCS-08-21W were established with awarded Centers in 2005. These Vanguard Centers worked with us for several years in helping develop the protocol and move the Study forward.

Last year, in 2007, Wave 1 Locations were added through a similar procurement that we are carrying out today. And those are the 33 red stars that were awarded last year as Wave 1 Locations.

At the same time, 14 additional Locations designated by blue triangles were awarded for future Waves, Wave 2 or Wave 3. This leaves the 58 centers that are available for this procurement, and that we're discussing today.

It's important to be clear about what is a Location and what is a Center. The

Locations are cites are those geographic Counties from which participants will be recruited. They're selected by a stratified probability sample of primary sampling units.

There are 105 Locations. Centers are the entities or institutions that will carry out this

Study at the Locations. They are selected by a competitive process. Each will cover, on the average, more than one location. And there will be 30 to 50 of them. We're estimating approximately 40.

Why did we choose to use a contract mechanism? As you're aware, this is a rigorous, uniform national Study with a core protocol that will need to be carried out in all locations. To assure that this consistent and rigorous core protocol is carried out in all sites, we felt that a contract mechanism was particularly important.

It also assures that the Study remains true to the goals of the funding agencies that have led the implementation of this project. However, I point out to you that on the continuum between the maximum independence, as with research grants, as shown in this scale, and the maximum control as with contracts. It is our intent that the National Children's Study be operated as close to a cooperative agreement as possible, but reserving the options to carry this out when needed as a contract.

Let’s talk about the key entities in the organization of the Study. The Inter

Agency Coordinating Committee that is responsible for federal oversight of this Study.

There is another, larger and broader federal Consortium that includes most of the federal agencies that are concerned with children's health and the environment with which we meet with periodically to update and to obtain input from broader federal agencies. There is the Advisory Committee that provides review and advice. The NCS

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Program Office is necessary to carry out the day-to-day scientific and operational management of this Study. There is a Steering Committee comprised of Center

Principal Investigators and representative federal scientists who engage in the primarily

-- in the primary scientific deliberations, as the Study goes forward, a Coordinating

Center responsible for data management and clinical coordination, and a not-yet constituted, but planned, Data Safety Monitoring Committee (DSMB) that will be responsible for monitoring the data and advising on when interventions providing information is necessary based on the findings of the Study.

Principal Investigators of all the Centers will be included and participate on the

Steering Committee. Let me quickly review the roles and responsibilities of the Steering

Committee. The Steering Committee is responsible for identifying problems and best practices that arise in the conduct of the Study. It's responsible for scientific input and expertise to support decision-making. It will make recommendations regarding scientific content of a study component. It will review -- provide review and approval regarding adjunct and add-on studies, in addition to other entities that also will be providing review and approval. It will be engaged in decision-making about non-direction changing and budget neutral issues related to the protocol and the manual of operating procedures.

And it will be involved in proposing changes to the protocol based on its experience in carrying out the protocol.

The various components of the Study I've already mentioned. They include the scientific support of the various reviews, the information technology development contractor that is working on a state-of-the-art information management system. There are the Vanguard Study Centers, the initial seven, and then the additional center, the 24

(17 new ones) that were awarded in 2007. This year there will be the Wave 2 Study

Centers. Then in 2009 will be the specimen repository and laboratory services coming on line.

We are frequently asked about what are the policies, with regard to access to data and publication. Our guiding, overriding principle is that there be maximum use and publication of the data from the National Children's Study. And that is a guiding principle. The primary hypotheses and primary outcomes of this Study will be analyzed and published through the center PIs and other participating investigators. We do plan

EAST- RFP NIH-NICHD-NCS-08-21E and WEST -RFP NIH-NICHD-NCS-08-21W for a data use and publications sub-committee. Actually there is a separate publications sub-committee and a separate data use committee that will provide oversight about publications and access to data respectively. A specimen oversight committee, as a guardian for the use of the valuable biospecimens is being formed. And public use data sets are to be available with each phase of this Study, as per NIH guidelines and confidentiality requirements. In all of these, the federal statutes and contractual agreements will prevail.

Adjunct studies will involve a portion of the sample using some of the National

Children's Study infrastructure and data to address additional or in-depth questions.

Examples might be in one or a couple of centers, to do a more in-depth study of functional neuroimaging of an exposed subgroup for mechanisms of effects on children's development. Funding for such studies will be by other mechanisms, not directly out of the National Children's Study funding. The process for review and approvals has been established. It is important to point out that specific proposals for adjunct studies are not a requirement of this solicitation.

The time line and milestones of this Study include: from the very beginning, have -- has been planning and various pilot studies and methods developments; then the initial contracts for the Vanguard Centers and coordinating center in 2005.

Congressional appropriation of $69 million as a line item for the National Children's

Study in 2007; completion of the first phase of the Study protocol and award of the

Wave 1 Study center contracts in 2007. In 2008, Congress appropriated for this year

$110.9 million, which enabled us to go forward with this procurement. Also through this year we expect the input and guidance from the various reviews including Scientific

Peer Review by the National Academy of Sciences, the review of the protocol under the

Paperwork Reduction Act by the Office of Management and Budget and various IRBs.

We are undertaking additional Center and Location procurements as we speak in 2008 and 2009. We will begin the pilot cohort at the Vanguard Centers at the end of 2008 or into the beginning of 2009. 2008 into 2009 will be the repository and laboratory procurements. In 2010 we will begin the full Study at the Wave I Centers with additional waives following each year. We anticipate first-Study results, at least of methodologic results, not outcome data, by 2011, with the first full data set being

EAST- RFP NIH-NICHD-NCS-08-21E and WEST -RFP NIH-NICHD-NCS-08-21W available in 2016.

And with that I'd like to thank you for your attention and turn the podium over to Dr. Ruth Brenner, who is the director of the Study Centers of the National Children's

Study, who will provide more detail about this procurement.

Dr. BRENNER: Thank you, Peter. And I'd also like to welcome you to the

Pre-proposal conference.

The goals of this presentation are to first review some central components of the Study design, to review the purpose of the solicitation and the mandatory requirements, to answer some general questions that were submitted in advance of this meeting. I want to remind you that some of the specific questions will actually be addressed in the amendment to the RFP.

Beginning with a broad overview of the Study design, we plan to enroll and follow 100,000 children from before birth to 21 years of age. The children will be enrolled primarily through enrollment of the mothers. The mothers, in turn, will be enrolled during or prior to pregnancy to allow assessment of early in-utero exposures.

Our goals are that children in the National Children's Study will be representative of all US children. And as Peter has described, we used a multi-stage probability sampling approach to achieve this goal.

In the first stage of sampling, 105 geographic areas were selected as the areas from which participants will be recruited. We refer to these as the Study

Locations. The Study Locations are in general single counties, or in some sparsely populated areas, groups of adjacent counties are joined to form a single-Study Location.

This is a slide that shows the 105 study locations that were selected by our colleagues at the National Center for Health Statistics in 2004.

The primary method of recruitment is through household screening. Once women are enrolled in this Study, we will follow a standard protocol that will include interviews, physical examinations, observational assessments, collection of environmental samples, and collection of biological specimens. The participants include mothers, fathers and children. So, that's a really, high level, broad overview of the

Study design. Additional details about the Study are available in Attachment 4, which is the overview of Study, design and methods. There's additional detail also available at

EAST- RFP NIH-NICHD-NCS-08-21E and WEST -RFP NIH-NICHD-NCS-08-21W that NCS public website. And in particular, I call your attention to the research plan.

That does bring us to the first question, which was submitted prior to this conference, which is: How should we reconcile the RFP with the research plan document? The research plan contains data collection tasks and other activities that are not in the RFP.

And the answer to that is that, where there are inconsistencies, the RFP takes precedence.

Turning now to some of the specifics of the procurement. The goal of this procurement is to award contracts to organizations that will be responsible for data collections at specified Study Locations. These specified Study Locations include 58 of the 105 Study Locations that were shown on the previous map. Again, contracts have already been awarded for data collections for the 47 other locations. And this is included in Attachment 11, which lists the Study Locations, as well as a map.

I think Peter touched on this, but I'll go over it again briefly. We received questions about the difference between a Study Location and a Study center. The

Study locations are the 105 geographic areas that were selected in the first stage of sampling. The Study centers are the organizations or entities responsible for carrying out the data collections.

The NCS is being implemented in three Waves. The anticipated dates for initiation of household screening in each of these Waves is shown on this slide. There are about a third of the counties in each of the Waves. The Wave 1 Centers will begin household screening in January of 2010, Wave 2 in 2011, and Wave 3 in 2012. Again, the goal is to achieve a sample that is reflective of all births in the United States with each Wave of implementation.

I want to add that these dates are the best dates that we have right now.

They are contingent on a number of factors, including receipt of requisite approvals and continued funding of this Study.

This brings me to the clarification to the RFP. In the statement of work, in the last paragraph of the first page of the statement of work, there -- it stated that field work for Wave 1 will begin in 2009. The clarification is that enumeration and screening of households for Wave 1 locations is scheduled to begin January 2010 as described in

EAST- RFP NIH-NICHD-NCS-08-21E and WEST -RFP NIH-NICHD-NCS-08-21W the overview of Study design and methods, as shown on the previous slide, and also shown in the Study time line, which is Attachment 10.

Some additional specifics about the Waves of implementation. For Wave 1, contracts have already been awarded for 34 of the 37 Study Locations. This includes the seven Vanguard locations, as well as 27 Wave 1 locations that were awarded in

2007. The current procurement includes the three remaining locations to be implemented with Wave 1. And there are separate documents, particularly in some of the attachments that discuss the time line for implementation for the Wave 1 locations versus the Wave 2 locations.

Contracts have also been awarded for 13 other locations, to be implemented in either Wave 2 or Wave 3. The remaining 55 locations are the primary subject of the current procurement.

So, this brings me to a second correction to the RFP. The 55 locations have been grouped into strata. These strata appear in Section M of the RFP with specific targets for the number of awards within each of the strata.

The first amendment to the RFP was issued about -- within a week of issuing the RFP. One of those lists of -- one of those strata incorrectly listed Warren County as

Warren County, New York and that was corrected to Warren County, New Jersey.

Again, Attachment 11 shows a study map and a list of locations. The counties are all correct as listed on Attachment 11.

I'll now turn to some of the -- mandatory criteria and other criteria specified in the RFP. Offerors shall prepare proposals to serve as a center to conduct data collections at one or more than one of the 58 specified Study Locations. This is mandatory criteria number one. Again, I'll refer you to Attachment 11.

A separate proposal must be submitted for each location in which the offeror is proposing to collect data. This is different than the way the procurement was set up last year. That is, a separate proposal is required for each location in which you are proposing to collect data.

No more than one center will be awarded a contract for data collections in a given location. That is there's no splitting of locations between multiple primary contractors. A single offeror can submit proposals for multiple locations, but, again, a

EAST- RFP NIH-NICHD-NCS-08-21E and WEST -RFP NIH-NICHD-NCS-08-21W separate proposal needs to be submitted for each location.

Each proposal will be evaluated independently. Thus, the information about the center should be included in each of the proposals, even if a center is proposing on multiple locations. Again, each of these proposals will be evaluated independently.

There's one exception, which is Harris County, and I'll talk a little bit more about Harris

County in a couple of slides.

The Study Location must be in the same state as the Study center, in a state that is contiguous with the state of the proposing center, or in a state that is not contiguous but is separated from the border of the state of the proposing study center by no more than 100 miles. These are the same mandatory criteria that appeared last year. I think it is important to emphasize the location of the study center is considered to be that of the location of the primary institution in the proposal.

So, turning again to a couple of questions. Will proposals for collection of data in a county that is not included in the list of 58 Study Locations be considered?

And the answer to that is: No, you have to propose on the locations that are included in those -- in that listing in Attachment 11.

Can existing Vanguard and Study centers send in proposals?

Yes, they would submit proposals the same way that any other offeror would.

Turning now to the enrollment goals. Again, participants are identified through -- primarily through screening of households in the selected neighborhoods or segments. The goal is to enroll sufficient number of women, such that 1,000 live births are enrolled over a four-year enrollment period in each of the primary sampling units.

Note that for both Wave 1 and Wave 2 locations, the enrollment period extends beyond the five-year contract period.

There are six exceptions to these enrollment goals. And they were posted in the RFP and are listed on this slide. The six -- for these six locations, where there are low number of births, the requirement was set at 600 births over the four-year enrollment period.

So, one question that we received is whether or not enrollment targets will be adjusted for other Study Locations that have relatively low number of births per year.

And the answer to that is: That we are not adjusting them at this time;

EAST- RFP NIH-NICHD-NCS-08-21E and WEST -RFP NIH-NICHD-NCS-08-21W however, as part of the technical approach, offerors can describe the challenges that they envision in enrolling a sample of 250 births per year. If, in addition to the issues faced by all the counties, there are unique challenges for a particular county, they should suggest alternate approaches that the review panel can then evaluate.

Turning now to mandatory criterion two, this criterion applies only to Harris

County, Texas for those offerors submitting proposals for data collections in Harris

County. This county contains two PSUs, so data collection in one of the PSUs will be implemented with Wave 2 and data collections in the second PSU will be implemented with Wave 3. The method for doing this is by adding additional neighborhoods or segments when the Wave 3 PSU is implemented. Because we will not have more than one contractor conducting data collections in a single location, offerors that submit a proposal for Harris County must demonstrate their ability to expand and conduct these additional data collections and add these additional segments with Wave 3. The Wave

3 PSU must be submitted as an option proposal. And the option proposal would be exercised at the appropriate time, given that there's funding and the Study continues to move forward with implementation of Wave 3 locations.

I'd now like to review some of the materials that were provided. Fred's already mentioned the evaluation criteria in Section M that you should pay attention to.

There also were a number of attachments. The ones that I'd like to highlight are

Attachment 3, the statement of work; Attachment 7, which contains the additional technical proposal instructions; Attachment 9, which is the estimates of annual effort by annual contract year (I'll talk a little bit more about that in a minute). The time line of operational activities is Attachment 10. The estimated number of visits and telephone calls is Attachment 12. The overview of the incentive plan is Attachment 13. For those

[items on the slide] that have stars by them, we provided separate tables and estimates for the Wave 1 and the Wave 2 centers.

Okay. Turning now to some specific clarifications. The estimates of annual effort by contract year are provided as guidance. Offerors can, and are, encouraged to calculate their own staffing needs, based on the requirements in the RFP and in the statement of work. Offerors are encouraged to explain the assumptions that they use to estimate their staffing needs.

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We received a number of questions about abstraction of data from medical records. The current plan includes abstraction of maternal and newborn records following delivery of the infant. The technical and business proposals should not include work and costs associated with other medical record abstractions. The protocols for additional medical record abstractions are being worked out at this time. So, at this point you should not include technical, or business, or costs associated with other abstractions.

We received a number of questions about the biosketch versus the abbreviated CV. The additional technical proposal instructions asked for an abbreviated

CV for key personnel, the principal investigator, and the Study coordinator or operational manager. It asked for a biographical sketch for other named Study staff.

The biographical sketch should follow the NIH format. For the abbreviated CV, we have left it up to you…