Maternal Folic acid Supplementation and Leukemia Risk in Children: A pooling of prospective data in the International Childhood Cancer Cohort Consortium (I4C)

This amendment responds to the following questions submitted:

1. Do you intend to award a sole source contract to International Childhood Cancer Cohort Consortium (I4C) or Murdoch Children Research Institute (or any other institution)?

Response: The data coordinating center for the I4C is housed at the Murdoch Children's Research Institute. The Murdoch Children Research Institute is the only institution that houses the data from the International Childhood Cancer Cohort Consortium (I4C).Thus, NCI plans to award a contract to the Murdoch Children's Research Institute on a sole source basis.

2. Is there any cost involved in the acquisition of the data?

Response: The Murdoch Children's Research Institute is the only designated data coordinating center for the I4C and thus they are the only one with the requisite data. The I4C data is not for sale to the public. Murdoch Children's Research Institute does not have the authority to sell any of the I4C data which is used only for scientific purposes.

3. Is this a new or recompete requirement?

Response: If it is a recompete, please let us know the current contract number and contract value. This is a new requirement.

4. Is there a page limit for the proposal?

Response: No, however, the response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement as stated in the pre-solicitation notice.

The National Cancer Institute (NCI), Epidemiology and Genomics Research Program (EGRP), Modifiable Risk Factors Branch (MRFB) plans to procure on a sole source basis services to pool data, create a master dataset and conduct statistical analysis for the two aims outline in this project below from Murdoch Children's Research Institute, Royal Children's Hospital, Flemington Rd., Melbourne, Australia.

This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1). The North American Industry Classification System code is 541990 and the business size standard is $14.0 Million.

Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract.

The period of performance is twelve (12) months from date of award.

It has been determined there are no opportunities to acquire green products or services for this procurement.

NCI/EGRP/MRFB is interested in the environmental causes of childhood cancer but it is difficult to study because cancer in children is rare and it is difficult to identify past exposure levels, particularly during important periods such as pregnancy. There is now a unique opportunity to prospectively study whether maternal folic acid supplementation affects leukemia risk in children. This data analysis project leverages on the resource of the International Childhood Cancer Cohort Consortium (I4C), a large consortium of several prospective mother-child cohorts. For this analysis, the plan is to pool data from five large prospective cohorts within the I4C. These five prospective cohorts have a combined sample size of 475,353 live births from 502,466 mothers. Approximately 200 cases of childhood leukemia and 550 cases of all cancers combined have been identified as of September 2011. Data is available on maternal folic acid supplementation as well as data to assess confounding. The goal of the proposed analysis is to test the hypothesis that folic acid supplementation in pregnant mothers reduces the risk of leukemia (acute lymphoblastic leukemia and other subtypes) in their children.

Contractor Requirements

The contractor shall pool data, create a master dataset, and conduct statistical analyses for the two aims outlined in this project:

1. To pool data from five prospective cohort studies within I4C to investigate whether folic acid supplementation and total folic acid intake in pregnant women (n=502,466) affect subsequent risk for leukemia in their children (n=475,353), controlling for confounding factors such as folic acid fortification in participating cohorts, B-vitamins and environmental toxicants (these data are available).
"The hypothesis is that both folic acid supplementation as well as total folic acid intake in pregnant women will reduce the subsequent risk of leukemia in the children."

2. To assess whether pregnancy BMI (obesity in pregnancy) is an effect modifier of the relationship between maternal folic acid intake and leukemia risk in the off-spring. The COR has previously reported on "An inverse association between obesity and fasting serum folate concentrations in women in a controlled feeding study and hypothesize that obesity in pregnancy will be an effect modifier."

After gathering the data, the contractor shall provide to the Contracting Officer's Representative (COR) a plan for the manuscript development. Upon approval of the plan, the contractor shall draft a manuscript describing the findings of the research. This will include all conventional subsections (i.e., Introduction/Background, Methods, Results, Discussion). The contractor shall then send the draft to the COR for review, who will incorporate feedback and suggestions into a second draft, and will submit the completed manuscript to NCI for internal review. The manuscript will be used by the NCI in the development of the final report.

The contractor shall provide adequate and appropriate staff, equipment, supplies, and space facilities necessary for carrying out the requirements of the statement of work. The contractor shall be responsible for developing the analysis plan and writing up the results.

Government Responsibilities

NCI program staff will review draft deliverables for review and approval. NCI will also provide the funding required for the contractor to perform the tasks outlined in this document.

Reporting Requirements and Deliverables

The contractor shall prepare the deliverables in accordance with the following schedule:

1) Analysis plan June 30, 2014
2) Data analysis December 31, 2014
3) First draft of manuscript describing results January31, 2015
4) Second draft of manuscript March 31, 2015

Since the Murdoch Children Research Institute is the only institution that houses the data from the International Childhood Cancer Cohort Consortium (I4C), a consortium of several large-scale prospective cohort studies, it is determined that they are the only source that can provide the data to complete the project.

This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 11 AM EST, on March 10, 2014. All responses and questions must be in writing and faxed to
240-276-5399 or emailed to Reyes Rodriguez, Contracting Specialist via electronic mail at reyes.rodriguez@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) through sam.gov. Reference: N02RC42511-57 on all correspondence.