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FBO DAILY ISSUE OF OCTOBER 02, 2010 FBO #3234
SOLICITATION NOTICE

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

Notice Date

9/30/2010
 

Notice Type

Justification and Approval (J&A)
 

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

Phil Hastings-Tickerhoff, Phone: 3014438402, Stephanie Powell, Phone: (301) 443-2696
 

E-Mail Address

phastings@nida.nih.gov, spowel1@mail.nih.gov
(phastings@nida.nih.gov, spowel1@mail.nih.gov)
 

Small Business Set-Aside

N/A
 

Award Number

HHSN271201000027C
 

Award Date

9/16/2010
 

Description

Justification for Other than Full and Open Competition "Source Selection Information - see FAR 2.101 and 3.104" 1. Identification of the agency and contracting activity. a. Federal agency and contracting activity. HHS, NIH, NIDA Neuroscience COAC b. Sponsoring organization. National Institute of Mental Health, Division of AIDS Research c. Project Officer Information. • Project Officer Name. • Mailing address. • E-mail address. • Telephone number. 2. Nature and/or description of the action being approved. Title: CNS HIV Anti-Retroviral Therapy Effects Research Extension (CHARTER Extension) a. Acquisition purpose and objectives. This CNS HIV Antiretroviral Therapy Effects Research Extension (CHARTER Extension) is a continuation of the epidemiological longitudinal study of the participants being studied under the existing award, N01MH22005, entitled, "CNS HIV Antiretroviral Therapy Effects Research (CHARTER)", which was awarded to the University of California at San Diego (UCSD) in September 2002. This contract is due to expire on August 31, 2010. The key objective of this follow-on initiative is to continue the assessment of subsets of the longitudinal patient cohort studied under the existing contract to advance the knowledge of the pathophysiology of HIV-Associated Neurocognitive Disorders (HAND). Through continued study of the preliminary findings it is hoped that biomarkers that annotate disease progression may be identified, along with answers to key follow-up questions relevant to the persistence of HAND that could inform therapy. There are several other critical areas relating to HIV neuropathogenesis that only the current research under the existing CHARTER contract is uniquely poised to address. Several intriguing findings relating to neurocognitive impairments that require more longitudinal data to confirm and evaluate are outlined below. 1) Among ARV treated cases with undetectable plasma and CSF viral load using standard assays, HIV could be detected in low copy numbers in 40% of the cases using an ultrasensitive assay (e.g. as low as 2 copies/mL); presence of HIV at these levels in CSF was associated with worse neurocognitive performance, suggesting that low level replication in the CNS/CSF may contribute to the persistence of HAND. As part of the CHARTER extension it will be useful to follow selected, apparently successfully treated, cases with persisting low-level HIV in CSF to determine if these cases are at higher risk to decline neurocognitively. Answering this question will contribute to our understanding of the possible mechanisms of continued neurocognitive impairment and potentially point to modified treatments (e.g. using agents that best penetrate into the CNS). 2) Longitudinal follow-up of CHARTER participants receiving cART suggests CSF virologic failure in ~25% of cases. This follow-up will allow the investigators to evaluate the predictors and consequences of CSF failure in terms of incident or worsening HAND. Without additional longitudinal observations the meaning and therapeutic implications of CSF virologic failure will remain unknown. 3) CHARTER data from cases in which at least 3 evaluations were available indicate that 26% of cases declined neurocognitively and 24% improved. Also, 27% developed increased white matter abnormality. By follow-up of these selected cases, it will be possible to establish the associated features of such progression, including the possibility that the process in part reflects evolution of viral strains in the CNS with discordant resistance. The factors that determine improved neurologic status and the biomarkers that annotate such improvement can also be defined. If this follow-on study to CHARTER is approved by the NIH, it is expected that over the course of the next 5 years, continued research data, such as neuromedical characterization, neuropsychological functioning, psychiatric and drug abuse variables, treatment data, various brain imaging results, and viral and host genetics information from specific groups of subjects will be collected and ultimately included with the accumulated clinical and research data stored. b. Project background. The CNS HIV Antiretroviral Therapy Effects Research Extension (CHARTER Extension) is a follow-on of the original contract entitled "CNS HIV Antiretroviral Therapy Effects Research (CHARTER)." This contract was competed under full and open competition and awarded to the University of California at San Diego (UCSD), contract number N01MH22005, in the amount of $34,361,547. The period of performance is September 1, 2001, to August 31, 2010. No prior or subsequent awards for this initiative have been made. The purpose of the award was to examine the presentation and predictors of neurologic complications of HIV in the era of combination antiretroviral treatment (ART). In performance of the existing 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. NIMH proposes to continue to extend the efforts of the CHARTER program by providing further follow-up of selected CHARTER patients whose disease progression over time may inform future therapeutic interventions. In addition, CHARTER has collected clinical samples, created datasets and internet-based applications which support scientific collaboration and research among NeuroAIDS investigators. 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. c. Rationale for two JOFOCs. This is 1 of 2 related JOFOCs associated with efforts under the current UCSD contract N01MH22005. Under this contract, UCSD has conducted a controlled longitudinal and cross-sectional study with AIDS subjects; in doing so, they have collected HIV samples and data which is invaluable to the NeuroAIDS research community. This JOFOC (CHARTER Extension) will allow the continuation of the contract objectives by following a subset of the original study population to answer further research questions about NeuroAIDS. The related JOFOC (CHARTER as a Resource) will allow the broad sharing of samples and data collected under the current contract, and under this JOFOC extension, with the research community. While the current contract does conduct both activities (the longitudinal multi-site study and the resource), the primary emphasis is the epidemiological study. The Resource JOFOC will greatly expand the resource function. The primary reasons that two JOFOCs are presented rather than one (and it is planned that two separate contracts will be awarded) are (1) the NIMH Program has requested that funds for each initiative be separately accounted for (which is easily done because the personnel and sites involved in each function will be different). This JOFOC will involve effort and costs from the coordinating center and the performance sites, while the Resource will be mainly a coordinating center function; (2) each effort serves a different function, and the SOWs are distinctly different (combining the 2 SOWs into one would be awkward); (3) this JOFOC is a non-severable study (CHARTER Extension) and the other JOFOC (CHARTER as a Resource) is a severable service. The market research and FBO advertising was conducted separately for each initiative. 3. Description of the supplies or services required to meet the agency's needs (including the estimated value). a. Project title. CNS HIV Anti-Retroviral Therapy Effects Research Extension (CHARTER Extension) b. Project description. (See attached Statement of Work for CHARTER Extension) • Requirement type. 1 Research & Development (R&D) 0 R & D support services 0 Support services (non-R&D) 0 Supplies/equipment 0 Information technology (IT) 0 Construction 0 Architect-engineer (A & E) services 0 Design-build 0 Other (specify): ____________________ • Type of action. 0 New requirement 1 Follow-on 0 Other (specify): Time only extension (No additional funds required) • Proposed contract/order type. 0 Firm-fixed-price 0 Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ 0 Cost-plus-fixed-fee 1 Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): Cost Reimbursement 0 Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ 0 Other (specify): ___________ 1 Completion Form Term form 0 Note: NIMH will be requesting "multi-year" contracting authority; if approved this will allow incremental funding of this non-severable services initiative. • Acquisition identification number. HHS-NIH-NIMH-RFP-10-016 c. Total estimated dollar value and performance/delivery period. The anticipated cost for the CHARTER Extension for 1 base year plus four optional years as follows. Base Amount Year 1 - 9/1/10-8/31/11 $1,904,016 Options Yr.2 - Option 1 (9/1/2011 - 8/31/2012) $1,696,892 Yr. 3 - Option 2 (9/1/2012 - 8/31/2013) $1,624,028 Yr. 4 - Option 3 (9/1/2013 - 8/31/2014) $1,672,748 Yr. 5 - Option 4 (9/1/2014 - 8/31/2015) $1,722,930 Total $8,432,190 Costs were estimated using prior year cost data and projections for research services in the field of expertise. 4. Identification of the statutory authority permitting other than full and open competition. 1 This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1 (a) (2)(ii). 0 This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996 0 This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a). 5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited. a. Name and address of the proposed contractor b. Nature of the acquisition and proposed unique qualifications of the contractor. The University of California at San Diego, as the coordinating center and data center for a current NIMH multi-site AIDS study, has the unique capabilities to perform this follow-on contract, based upon the following: 1) Access to subjects to continue the research study. Only UCSD, and its sites, have access to the longitudinal patient cohort studied under the current CHARTER contract N01MH22005, to follow a subset for this follow-on study. For this follow-on study, a minimum of 180 patients that have undergone virologic and neurocognitive assessments by the CHARTER group under the current contract are required to address the following three objectives: a) to explore whether low-level replication in CSF predicts HAND; b) to examine whether CSF virologic failure predicts neurocognitive decline and identify neuroimaging indicators of increased brain injury; and c) to examine a subset of the CHARTER cohort who are receiving drug therapy and undergoing cognitive change, or increasing white matter abnormality, to understand predictors of neurological injury. 2) Unique experience, expertise, and infrastructure to assess the subjects in this follow-on study using established and approved protocols. UCSD is the only resource that has the capabilities to assess a subset of the longitudinal patient cohort previously studied under the existing contract. Only UCSD, working with its sites, can coordinate the continued assessments and data collection efforts for this multi-site follow-on study. Under the current contract, UCSD and its sites has collected longitudinal data, i.e., neuromedical, neuropsychological, psychiatric, drug abuse, antiretroviral treatment, brain imaging, viral and host genetics data, on a subset of 600 participants based on a cohort of 1,600 clinical patients. The 600 participants have been highly screened by the original CHARTER leadership of physicians and investigators. The CHARTER Extension would permit gathering of critical longitudinal data and samples on especially informative, well controlled cohorts of the original subject population. It is crucial that the original CHARTER leadership remain the sole source for the CHARTER Extension. Further characterization of these patients in particular, and collection of their biological samples may serve to illuminate the persistence of HIV in the central and peripheral nervous system, establish biomarkers for disease progression, and define clinical endpoints for therapeutic clinical trials. 3) Unique research qualifications. UCSD and its sites constitute the primary research group in the Neuro-AIDS field. They have extensive expertise in neuromedical, neurobehavioral, neuroimaging and virology research. Only UCSD and its sites have the necessary expertise in neuromedical, neurobehavioral, neuroimaging, and virology research to continue this work. 6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies. Source sought notices for both small businesses only and for all sources was posted in FedBizOpps on January 26, 2010, for 15 days. Only the incumbent UCSD responded to the notice for "all sources". As required for JOFOCs, a presolicitation notice was posted on March 26, 2010, (amended on March 29, 2010) with a response date of April 12, 2010 - no responses received. 7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable. There is sufficient data from the current contract to evaluate the cost reasonableness of this follow-on work. Salary rates will be compared to the current UCSD rates. UCSD and each subcontract site has a current indirect rate agreement. The IGCE was prepared using current data from the existing contract. 8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted. See response to item #6, above. 9. Any other facts supporting the use of other than full and open competition. None. 10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition. No sources, other than the incumbent, expressed an interest in doing this project. 11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services. If it is determined that there is a continued need for this research at the conclusion of the proposed extension period, the Contracting Officer and the Project Officer will conduct a thorough analysis of the requirement to determine if the requirement could be transferred to another contractor or if full and open competition was feasible. 12. Program office certification. This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government's minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete. Official Name & Title Signature Date Project Officer Jeymohan Joseph, Ph.D., Chief, HIV Pathogenesis, Neuropsychiatry and Treatment Branch, Division of AIDS Research Project Officer's Immediate Supervisor Dianne Rausch, Ph.D., Deputy Director, Division of AIDS Research Head of the Sponsoring Program Office Philip Wang, MD., Dr.PH, Deputy Director, NIMH, Acting Director, Division of AIDS Research 13. Contracting Officer Certification This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete. Official Name & Title Signature Date Contracting Officer Bruce E. Anderson, M.Ed. Section Chief/Supervisory Contracting Officer, NIMH Research & Development CMS, NIDA-Neuroscience COAC 14. Chief of the Contracting Office and Head of the Contracting Activity signature(s). Official Name & Title Signature Date Chief of the Contracting Office Ms. Suzanne Stinson, Chief Contracting Officer and Branch Chief, NIMH and NIA CMB, NIDA Neuroscience - COAC Director of Office of Acquisitions, NIDA James L. Quinn, Director Office of Acquisitions, NIDA Head of the Contracting Activity Diane J. Frasier, Head of the Contracting Activity
 

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: University of California San Diego, 9500 Gilman Drive, La Jolla, California, 92093-0934, United States

Zip Code: 92093-0934
 

Record

SN02302948-W 20101002/100930235449-e06d9d1afe1975637c55d157f693a55d (fbodaily.com)
 

Source

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

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