October is National Children’s Health Month. The National Children’s Study’s (Study) goal of increasing the health and well-being of our nation’s children is always on the minds of Study planners, and that is especially true this month.
If additional funds are provided in the fiscal year 2007 federal budget for the Study, the National Institute of Child Health and Human Development (the Study’s home institute at NIH) is planning to award contracts to more organizations having the ability to serve as Study Centers. Study Centers will manage Study operations at one or more previously designated Study sites (counties) (visit http://www.nationalchildrensstudy.gov/studylocations/ for a map and list of the Study’s sites).
In the instance that NICHD receives adequate funding for the Study, and is able to make new contract awards, the Study is releasing a special notice (below) explaining the process for submitting a proposal to be a Study Center. This special notice can also be found on the Federal Business Opportunities website at: http://www.fbo.gov/spg/HHS/NIH/NICHD/Reference%2DNumber%2DNICHD%2DSN%2D2007%2D07/listing.html
This special notice of the anticipated Request for Proposals (RFP) is to alert as early as possible any interested institutions and research investigators to the possibility and structure of a RFP. However, interested investigators should be aware that the RFP release, expected early this winter, is tentative pending fiscal year 2007 funding.
For more information on the Study please visit www.nationalchildrensstudy.gov. Any questions concerning this special notice must be submitted in writing to Elizabeth J. Osinski, Contracting Officer, at email@example.com or addressed to Ms. Elizabeth Osinski, Office of acquisitions, NIDDK, NICHD Branch, Executive Building, Suite 7A-07, 6100 Executive Boulevard, MSC 7510, Bethesda, MD 20892-7510.
Special Notice for National Children’s Study Centers
The National Institute of Child Health and Human Development (NICHD) is planning to award up to 15 contracts to organizations having the ability to serve as Study Centers for the National Children's Study (NCS), if additional funds are provided in the FY 2007 President’s Budget.
Expanding the National Children’s Study to include additional Study Centers will require and is contingent upon additional funds being made available for the Study. The proposed President’s Budget for FY 2007 does not currently include funds for the National Children's Study. However, the House and Senate Appropriations Committees have signaled strong support for the NCS for 2007. The House Committee has included bill language "directing NICHD to dedicate $69,000,000 from within funds provided to continue the National Children’s Study, including funding all Vanguard Centers and any other activities that were planned for fiscal year 2007". The Senate Committee supported "full and timely implementation of the Study" [NCS] and stated that it has included funds within the Office of the Director to continue the Study. If funds were to be provided in 2007, awards for additional Study Centers is contingent upon the solicitation, receipt, evaluation and negotiation of technically acceptable proposals. It is currently estimated that technical and cost proposals would be submitted in March of 2007. Therefore, because of this expression of strong support for the NCS, this special notice is posted to alert prospective offerors to the possibility of awards for additional NCS Study Centers. The solicitation for additional Centers, Request for Proposals, (RFP) is being prepared and posting it can be anticipated in approximately 8 weeks. The RFP that will be issued on or about December 12, 2006, will contain language that states that "funds are not presently available for this procurement and that the Government's obligation to award contracts under this RFP is contingent upon the availability of appropriated funds from which payment for contract purposes can be made." Offerors are advised that any expenses incurred in the preparation of proposals, will not be reimbursed by the Government. A RFP due date of on or about March 15, 2007 can be anticipated. However, no resultant contract awards for new Study Centers can or will be made unless the FY 2007 Federal budget includes sufficient funds for the National Children’s Study.
Background information on the NCS is available at www.nationalchildrensstudy.gov. The NCS is a large, long-term longitudinal study of environmental influences on children’s health and development. This Study will explore a broad range of environmental factors, both helpful and harmful, that influence the health and development of children. For this Study, environment is broadly defined to include biological, chemical, physical, social and behavioral influences on children. The range of outcomes includes, for example, obesity, diabetes and physical development; injuries; asthma; pregnancy-related outcomes; and mental health issues. Likewise, a wide range of environmental influences will be examined for their impact on children’s health and development. These include, but are not limited to air pollutants, drinking water contaminants, soil and dust contaminants, dietary nutrients, dietary contaminants, parental occupational exposures, infectious and allergic agents, genetics and social and behavioral characteristics. The Study’s goal is to better understand the role of how these factors, alone and in combination, affect or are associated with children’s health, disease and development. The NCS will include a sample of approximately 100,000 children born in the U.S. Enrolled women and, when possible, their partners will be assessed for a wide range of exposures and personal characteristics early in pregnancy or upon pre-pregnancy enrollment. Monitoring of the mother’s exposures will continue throughout pregnancy to birth, and possibly beyond. The child will then be followed for a wide range of health and developmental outcomes and NCS defined environmental exposures throughout childhood until at least 21 years of age.
Information will be collected from participants in the Study who reside in one of the 105 locations (mostly counties selected as primary sampling units for the first stage of a multi-stage sampling process). The Study locations are identified on the map and list of Study Locations at www.nationalchildrensstudy.gov/studylocations/. The information will be collected by Study Centers that perform the data collection activities in the locations or counties. It is important to distinguish the Study Centers (organizations or institutions engaged in conducting the Study) from the Locations (geographic areas, counties) where eligible participants reside.
In the initial phase of this Study, data will be collected in seven geographic areas in the United States. Data collection in each of these seven geographic locations is being conducted by a single Study Center, referred to as a Vanguard Center. Thus, there are a total of seven Vanguard Centers. The Vanguard Centers will be engaged in completing and finalizing the core protocol and piloting the protocol prior to its full implementation. Contracts for the Vanguard Centers were awarded in the Fall of 2005.
Additional contracts are needed to establish Study Centers to conduct the data collections in the remaining 98 Study Locations (from the original sample of 105 locations). It is anticipated that an RFP to solicit proposals to establish additional Study Centers will be posted within the next 8 weeks. It is anticipated that approximately 10 to 15 additional Study Centers which will cover 30 to 45 study locations will be awarded depending on available FY 2007 funds. In addition to the requirements listed below, Study Locations, will be sought such that, in combination, births across the selected locations are representative of all U.S. births on a number of factors. Future solicitations for additional Study Centers to cover the remaining locations are dependent upon availability of funds.
Offerors competing for the 10 to 15 additional Study Centers must demonstrate the ability to conduct the Study in the locations that the offeror proposes. Specifically, offerors must document in their technical proposal, the following:
- Demonstrate a clear understanding of the complexity of this Study, including the use of a complex multi-level sampling strategies for selection of Study locations and neighborhoods within locations from which participants will be recruited; the longitudinal nature of the data collection; the need to collect, process, and ship environmental samples and biologic specimens from multiple sites; and the need to collect interview data from multiple participants including pregnant women, fathers, and other primary caregivers, and children;
- Demonstrate an ability to gain community support and input to optimize subject recruitment, retention, and dissemination of Study findings;
- Provide evidence of the ability to identify, recruit, and enroll a sufficiently large population of women, either prior to pregnancy or during early pregnancy, such that 1000 live births are enrolled in the study over a 4-year enrollment period in each location;
- Provide evidence of the ability to collect, process and ship/transport biologic specimens from mothers, fathers, and offspring; and environmental specimens from the household and neighborhood environment;
- Provide evidence of the ability to enroll participants and collect Study specimens and information (environmental, interview, and biologic) prior to conception and early in pregnancy;
- Demonstrate the ability to retain and follow Study participants from all socioeconomic groups, including the medically underserved. [It is anticipated that measurements that require in-person contact will occur at least once in a subset of participants enrolled prior to pregnancy, two times during pregnancy, around the time of delivery, at 6 months, one year, 3 years, 5 years, and every 3-5 years until the age of 21 years. Collection of interview data may occur at more frequent intervals.];
- Provide evidence of the ability to collect cord blood and placental tissue at the time of delivery;
- Provide evidence of understanding and experience in packaging and transporting biological and non-biological samples to a laboratory(ies) and repository(ies) from the Study Center. (Note: The National Children’s Study, (NCS) Coordinating Center (CC) will develop standard operating procedures in collaboration with the Study Centers.);
- Provide evidence of the ability to perform a standardized examination of the newborn as well as other clinical and neurodevelopmental exams throughout childhood;
- Provide evidence of the ability (equipment and expertise available) to perform fetal ultrasounds; Dual-energy X-ray Absorptiometry (DXA); detailed developmental and psychometric assessments; placement, calibration and use of instruments to collect environmental samples, and other measures as selected in the development of the Study Protocol;
- Demonstrate previous experience in the implementation of Quality Assurance/Quality Control activities covering the collection of interview data; collection, storage, and shipping of biologic and environmental specimens; and collection of field observational data;
- Provide evidence of qualified personnel to oversee all aspects of the Study, as outlined above; and
- Provide evidence of previous work with a centralized coordination center in the development of protocols and procedures.
The following additional requirements must also be documented in your technical proposal:
- Organizations proposing to become a Study Center must propose to carry out the Study at one or more of the 98 previously designated Study locations (see www.nationalchildrensstudy.gov/studylocations/).
- Study Locations (Counties) where a proposing Study Center offers to conduct the study must be located either in the state where the proposing Study Center is located or in a state that is contiguous with the state of the proposing Study Center. Location of the Study Center is considered to be that of the location of the primary institution in the proposal.
- Where feasible, offerors are strongly encouraged to propose to be a Study Center for data collection in multiple locations. [The government understands that this is not feasible for offerors located in Hawaii or in Maine, where only one Location meets the requirement specified in no. 2 above. Offerors from these states will not be expected to bid on more than one Location.] There is no limit to the maximum number of locations that an offeror may include in the proposal. However, proposals will be evaluated based on technical merit of which one aspect includes ability to engage relevant community entities within each location. Other factors include, but are not limited to, costs and other factors to best address the needs of the full Study.
- Only one center will conduct the Study at any single location. Locations or counties may not be shared or split between more than one Study Center.
- Organizations and institutions are encouraged to establish partnerships and teams with other entities where appropriate or necessary to establish the strongest capability to perform the Study. Each newly established Study Center awarded through this procurement will operate on an equal level with the already established Vanguard Centers. Both the Vanguard Centers and the newly established Centers will operate under federal contract guidelines and will be equally accountable to the Program and Contracting Offices of NICHD.
- Engagement and participation of the communities in Study Locations is essential for successful conduct of the Study. Therefore, interested offerors are encouraged to establish relationships and participation with communities and community organizations of the proposed Study Locations.
- Organizations are requested to forward comments and concerns regarding anticipated problems and suggestions for the upcoming RFP for consideration by the Government in preparation of the RFP. Comments must be received by November 16, 2006.
- Offerors can anticipate that a pre-proposal or bidder’s conference to answer questions and provide clarification about this solicitation will be announced and scheduled with the RFP.
- Current Vanguard Centers are eligible to submit proposals to serve as Study Centers for additional locations as outlined above.
The Request for Proposals (RFP) is expected to be issued in approximately 8 weeks. Another Pre-Solicitation Notice will be published in FEDBIZOPPS prior to issuance of the RFP. Any questions concerning this announcement must be submitted in writing to Elizabeth J. Osinski, Contracting Officer, at firstname.lastname@example.org or addressed to Ms. Elizabeth Osinski, Office of Acquisitions, NIDDK, NICHD Branch, Executive Building, Suite 7A-07, 6100 Executive Boulevard, MSC 7510, Bethesda, MD. 20892-7510 (if sending by overnight carrier-6100 Executive Boulevard, Suite 7A-07, Rockville, Maryland 20852).