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A -- Follow up to NEOPAIN, Pain, Morphine and the Developing Brain: School Age Outcomes

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Reference-Number-NICHD-CDBPM-SN-2007-03Federal

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The National Institute of Child Health and Human Development (NICHD) plans to negotiate a three-year sole-source contract with Arkansas Children’s Hospital to continue a follow-up study on preterm infants originally enrolled in the NEOPAIN Grant study. This follow-up aims to assess the long-term effects of pain and morphine exposure on the children’s health, cognitive development, executive functioning, attention, self-regulation, academic skills, and overall well-being as they reach ages 6 to 8. The original participant data are not legally accessible to NICHD, making Arkansas Children’s Hospital uniquely positioned to perform the study because it holds the necessary patient cohort and data. No other known domestic contractor has access to a comparable cohort or the required longitudinal data, meaning any new contractor would face significant challenges and costs to replicate the initial study. Due to the proprietary nature of the cohort data and the specialized expertise developed during the original study, competition for this contract is deemed impractical and would cause unacceptable delays. The solicitation serves primarily to identify whether any other entity can demonstrate capability and access to a similar cohort for this longitudinal research. Responses from potential contractors must include documented access to a comparable cohort and relevant longitudinal data to be considered. Ultimately, the decision not to competitively procure the contract rests solely with the government, reflecting the specialized and unique circumstances tied to this important developmental health study.

General Info

NICHD to sole-source three-year follow-up study contract with Arkansas Children’s Hospital on preterm infants.

Agency

N/A

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Place of Performance

Not specified

Set-Aside

NONE

Documents

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Full Description

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The National Institute of Child Health and Human Development (NICHD) intends to negotiate with Arkansas Children?s Hospital for a three-year noncompetitive contract to conduct a follow up study of the surviving cohort of preterm infants enrolled in the NEOPAIN Grant study 1-R01-HD036484. The Government is interested in obtaining status and information about the role of pain and its long-term effects on the overall health, well being, cognition, academic skill, executive functions, self regulation, attention and school status of the children now reaching ages 6 through 8. As a result, the NICHD does not have legal rights to the identifying data on the original cohort participants. Therefore, the cohort could not be transferred to any other contractor by the NICHD. In order to perform the continued work a new prospective contractor would need access to a comparable cohort of mothers and infants, similar in age, that have been subject to a comparable assessment from infancy. With the exception of the incumbent (Arkansas Children?s Hospital), there is no domestic source presently known to the NICHD that has access to such a cohort and ownership of the specific patient population (required for this study) via data from the initial NEOPAIN Grant. It will cost the government additional time and effort to duplicate the initial NEOPAIN Grant study 1-R01-HD036484. All of the above factors, taken together, make Arkansas Children?s Hospital uniquely qualified for carrying out this study. Authority: 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1. Inherent duplication of cost to the Government and unacceptable delays in completing the project make competition unfeasible for this final phase of the study, which provides for longer follow-up and data analysis. The purpose of this synopsis is to determine whether there are other sources capable of meeting the Government?s requirements as described. Contractors are encouraged to submit three (3) copies of their written Capability Statements to Ms. Susan Cortes-Shrank, Contract Specialist, at the address provided within 45 days of publication of this synopsis. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received should document access to a comparable cohort of mothers and infants, similar in age, that have been subject to a comparable assessment from infancy. The capability statement will be considered solely for the purpose of determining whether to conduct a competitive procurement. Overnight deliveries should be mailed to the National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Boulevard, MSC 7510 Bethesda, Maryland 20852. See Numbered Note 22 ****. No collect calls or facsimile transmissions will be accepted.

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