Loren Data's SAM Daily™

FBO DAILY ISSUE OF MARCH 28, 2010 FBO #3046
SOLICITATION NOTICE

A -- CNS HIV Anti-Retroviral Therapy Effects Research Extension (CHARTER Extension)

Notice Date

3/26/2010
 

Notice Type

Presolicitation
 

NAICS

541720 — Research and Development in the Social Sciences and Humanities
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Institute on Mental Health, Contracts Management Branch, 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, Maryland, 20892-9661
 

ZIP Code

20892-9661
 

Solicitation Number

HHS-NIH-NIMH-RFP-10-016
 

Point of Contact

Bruce E. Anderson, Phone: 301-443-2234, Stephanie Powell, Phone: (301) 443-2696
 

E-Mail Address

banderso@mail.nih.gov, spowel1@mail.nih.gov
(banderso@mail.nih.gov, spowel1@mail.nih.gov)
 

Small Business Set-Aside

N/A
 

Description

The National Institute of Mental Health (NIMH) intends to issue a solicitation on a sole source basis to the University of California San Diego, entitled "CNS HIV Anti-Retroviral Therapy Effects Research Extension (CHARTER Extension). The proposed contract action is for R&D services for which the Government intends to solicit and negotiate with only one source under authority of FAR 6.302-1. This notice of intent is not a request for competitive proposals. However, responsible sources may express their interest by submitting a capability statement or proposal. All capability statement/proposals received within thirty days after date of publication of this synopsis will be considered by the government. 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 will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Background: The CNS HIV Antiretroviral Therapy Effects Research (CHARTER) study was awarded in September 2002, under contract N01MH22005, to the University of California at San Diego (UCSD) to examine the presentation and predictors of neurologic complications of HIV in the era of combination antiretroviral treatment (ART). In performance of this contract, UCSD has examined 1,574 participants cross-sectionally, 657 participants longitudinally, and is continuing to follow additional subjects through the contract expiration date in August 2010. The specific requirement to be accomplished is for the Contractor to continue the CHARTER program on the longitudinal patient cohorts. The importance of this CHARTER Extension lies in the highly selected longitudinally followed patient population with concomitant samples, data and the clinical research opportunities they present. Goals and Objectives: The goal of the follow-on Research (CHARTER Extension) is to continue assessment of approximately 180 patients from the required CHARTER longitudinal cohort (i.e., about 30 per site) studied under the predecessor contract. The proposed program may help to identify the biomarkers that annotate disease progression and address key questions relevant to the persistence of HIV-Associated Neurocognitive Disorders (HAND) and inform therapy. The objectives are: 1. To explore whether low-level HIV replication in the CSF predicts HAND; 2. To examine whether CSF virologic failure predicts neurocognitive decline and identify neuroimaging indicators of increased brain injury; and 3. Examine the predictors and outcomes of decline or improvement of neurological injury and drug resistance profiles by examination of cases that are receiving combination ART and undergoing cognitive changes. Drug resistance profiles in CSF and Plasma of those with neurocognitive decline and increasing white matter abnormality are to be examined to determine the contribution of evolution of viral strains with discordant resistance. A supplementary aim is to define the extent to which nerve injury is reversible in the context of ART. The proposed contractor is uniquely qualified to perform these services for the NIMH based on the following considerations: 1. Access to the longitudinal patient cohort studied under the predecessor CHARTER contract. A minimum of 180 patients that have undergone virologic and neurocognitive assessments by the CHARTER group are required to address the following three objectives: 1) to explore whether low-level replication in CSF predicts HAND; and 2) to examine whether CSF virologic failure predicts neurocognitive decline and identify neuroimaging indicators of increased brain injury; and 3) examine a subset of CHARTER cohort who are receiving drug therapy and undergoing cognitive change, or increasing white matter abnormality, to understand predictors of neurological injury.; 2. The ability to coordinate the transfer of clinical samples and datasets from the CHARTER Extension to the accompanying CHARTER as a Resource; 3. Expertise in neuromedical, neurobehavioral, neuroimaging, and virology research. This initiative was previously advertised under sources sought announcements #NIH-MH-2010-003 and #HHS-NIH-NIMH-SBSS-10-009. Anticipated Period of Performance: The anticipated period of performance is 5 years. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Government Point of Contact: Stephanie Powell Contract Specialist, NIDA Neuroscience COAC NIMH R&D Contracts Management Branch 6001 Executive Blvd., Rm. 8154 (MSC 9661) Bethesda, MD 20892 [For commercial overnight services use: Rockville, MD 20852] Voice: 301-443-2696 Fax: 301-443-0501 E-mail: spowel1@mail.nih.gov Collect calls will not be accepted.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIMH/HHS-NIH-NIMH-RFP-10-016 /listing.html)
 

Place of Performance

Address: La Jolla, California, 92093, United States

Zip Code: 92093
 

Record

SN02103683-W 20100328/100326234658-a35fc41f1c2500736a6685bb90b3c44f (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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