PRESOL | A | National Research Roster of Huntington's Disease for Patients and Families

FBO DAILY ISSUE OF OCTOBER 07, 2009 FBO #2874
SOLICITATION NOTICE

A -- National Research Roster of Huntington's Disease for Patients and Families

Notice Date: 10/5/2009
Notice Type: Justification and Approval (J&A)
NAICS: 541712 — Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
Contracting Office: Department of Health and Human Services, National Institutes of Health, National Institute of Neurological Disorders and Stroke, 6001 Executive Boulevard, Neuroscience Center, Suite 3287, MSC 9531, Bethesda, Maryland, 20892-9531
ZIP Code: 20892-9531
Solicitation Number: NIH-NINDS-09-02
Archive Date: 10/28/2009
Point of Contact: Helene C Braun, Phone: 301 496-1813
E-Mail Address: hb106s@nih.gov
(hb106s@nih.gov)
Small Business Set-Aside: N/A
Award Number: N01NS32357
Award Date: 9/28/2009
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 b. Sponsoring organization. National Institute of Neurological Disorders and Stroke. c. Project Officer information. • Project Officer name. Margaret Sutherland, Ph.D. • Mailing address. Neuroscience Center, 6001 Executive Blvd., Room 2203, MSC 9525, Bethesda, Maryland 20892-9525 • E-mail address. sutherlandm@ninds.nih.gov • Telephone number. 301-496-5680 2. Nature and/or description of the action being approved. a. Acquisition purpose and objectives. The specific objective of this contract is for the continued maintenance of the National Research Roster of patients and families affected by Huntington's Disease. The Contractor collects data on persons with Huntington's Disease, persons at risk of the disease, and people who are related to those with or at risk of the disease. The Roster is used to contact potential participants for research studies, to locate individuals of particular research interest, and to provide statistical and demographic data on Huntington's Disease. The purpose of this contract extension is to systematically closeout and transfer ownership of the voluntary roster of patients and families affected by Huntington's Disease (HD Roster) to Indiana University. The HD Roster has been used to contact potential participants for research studies, to locate individuals of particular research interest, to notify individuals of current clinical trials, and to provide statistical and demographic data on Huntington's Disease. During this contract extension, ownership of HD Roster data will be transferred to Indiana University, for data where informed consent for this transfer has been obtained. For Roster participants who do not consent to have their data transferred to the Indiana University, data for these participants will be destroyed. Indiana University will also, during the consent process, determine through informed consent, which roster participants are willing to have contact information shared with the Huntington Disease Society of America's (HDSA) sponsored database, HDTrials.org, and/or similar organizational databases directed at identifying participants for HD clinical research studies. Indiana University will assume full responsibility for the confidentiality and security of all records upon transfer of ownership (when the contract expires) and will hold the Government harmless for any and all liability issues post-transfer. The HD Roster will also communicate closeout plans with HD Research investigators to allow submission of data requests and data transfer for approved data requests prior to the expiration of the contract. Strict confidentiality of records shall be maintained. The Contractor shall comply with the Privacy Act provisions of the contract. b. Project background. This project is a continuation of an ongoing contract. The contract number is N01-NS-3-2357; (i) Contractor: Indiana University; (ii) Period of Performance - September 30, 2003 - September 29, 2009; (iii) Total dollar amount obligated to date: $1,802,690; (iv) The initial award was competed in 1979. Since that time, all subsequent awards were sole source. The basis for the approved JOFOCs was FAR 6.302-1(a)(2). 3. Description of the supplies or services required to meet the agency's needs (including the estimated value). a. Project title. National Research Roster for Huntington's Disease Patients and Families b. Project description. The Contractor shall maintain and execute closeout procedures for the Roster of patients and families affected by Huntington's Disease (HD Roster). The Contractor shall maintain and update data on persons with Huntington's Disease, persons at risk of the Disease, and people related to those with or at risk of Huntington's Disease. The data collected consists of: a). Pedigree information, including a complete family history and demographic data; b). Educational background; c. Socioeconomic level; d). Occupational history; e), Clinical history of patient including particularly specification of symptom onset and symptom description (chorea, rigidity, etc.); f) Psychiatric history of patient and family members with special attention to any emotional or behavioral problems or changes. Special attention should be given to recording suicides attempted and completed. In closeout procedures the Contractor shall obtain informed consent from HD Roster participants to transfer ownership of consented data to Indiana University. In addition, the Contractor shall obtain informed consent to allow sharing of specific Roster data with other organizations involved in recruitment for clinical studies, such as the HDSA sponsored database, HDTrials.org. In implementing this transfer the Contractor will explain exactly to HD Roster participants how information on a patient or family member will be used by Indiana University and the voluntary nature of the transition of ownership to Indiana University's database. The Contractor shall ensure that HD Roster participants understand that they may elect to transfer all, some or none of the information the HD Roster has collected, to HDTrials.org or any other organizational database. The Contractor shall publicize the closeout plans for the HD Roster: 1) to HD researchers, to ensure continuity of data access during the closeout period; and 2) to HD Roster participants, to inform participants of opportunities for participation in HDTrials.org. In completion of the closeout phase of this contract, the Contractor shall supply a summary of HD Roster activities, including studies undertaken, and papers published to HD Roster participants. • Requirement type. 1Research & 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 0 Follow-on 1 Other (specify): Two Year Extension to the Current Contract • 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 0 Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ 0 Time and materials 0 Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ 1 Other (specify): Cost Reimbursement 0 Completion Form 1 Term form • Acquisition identification number. NINDS-09-02 c. Total estimated dollar value and performance/delivery period. The total estimated value of the two year extension (September 30, 2009 - September 29, 2011) will be. 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). 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(s). Indiana University Research and Sponsored Programs 620 Union Drive, Room 618 Indianapolis, Indiana 46202-5167 b. Nature of the acquisition and proposed unique qualifications of the contractor(s). A noncompetitive procurement is requested because of the impracticability of another contractor being able to provide the experience, efforts, and expertise of the current Contractor; necessary for performance of the closeout phase of this contract at the current operational level, without significant time delays and substantial duplication of costs which are not expected to be recovered through competition. Additionally, the highly sensitive nature of the information contained in the Huntington's Disease Research Roster requires special handling procedures. The records of those in the Roster are highly confidential due to the fact that participating individuals are either at risk for, or affected by, a fatal hereditary disease. In addition, the unique relationship which exists between the patients, families, and Indiana University cannot be duplicated with other organizations. The Statement of Work for the current Indiana University contract has required the Contractor to submit requests for identifiable information to the Roster participant in writing, and to receive written permission from the Roster participant for release of information. The Informed Consent Form under the current contract contains a "Privacy Act Notification Statement", which informs the Roster participant or potential Roster participant, that access to the information given for the HD Research Roster is restricted to staff members of the NIH, and Indiana University, who are responsible for maintaining the Roster. However, on certain occasions, information "may" be disclosed outside the NIH and/or Indiana University to: 1) a Congressional Office upon the Roster participant's request; and 2) the Department of Justice under certain conditions. Otherwise, the medical information given for the HD Research Roster will not be disclosed to anyone without the Roster participant's written permission, or that of the Roster participant's legally authorized representative. The current Contractor, Indiana University, would have to contact over 4,300 individuals on the Roster to obtain their written consent to have their record(s) from the Roster transferred to a new Contractor. Since this extension is intended to allow a closeout phase for this contract, it is impractical to transfer data to another contractor prior to closeout, since this would more than double the cost of the closeout and substantially delay the closeout procedures. 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. A notice of our intent to extend the current contract (N01-NS-3-2357) for a two year period with Indiana University was published on FedBizOpps on July 1, 2009 for 45 days and was amended on August 27, 2009. Another 15 day period for response to this notice elapsed on September 11, 2009. We received no response to the announcement. 7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable. The Contracting Officer will perform a cost analysis on all elements of cost for the two year extension. A Certificate of Current Cost or Pricing Data will be requested at the conclusion of negotiations. An award will be made only if during discussions it is shown that the anticipated cost to the Government will be fair and reasonable. 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. The NINDS held several teleconferences with Huntington's Disease organizations and clinical investigators. Based on input from these groups, it was clear to everyone that the data held within the Roster is unique and would be difficult to replicate by other sources (Privacy Act issues) without duplication of effort and significant cost to the Government. In addition, a FedBizOpps notice was posted on July 1, 2009 and amended on August 27, 2009. No sources have expressed an interest, in writing, in the proposed acquisition. 9. Any other facts supporting the use of other than full and open competition. The use of other than full and open competition is requested because of the impracticability of another Contractor being able to provide the experience, efforts and expertise of the current Contractor necessary for the performance of the closeout phase of this contract without significant time delays and substantial duplication of costs. In addition, the highly sensitive nature of the information contained in the Roster requires special handling procedures. The records of those individuals listed in the Roster are highly confidential due to the fact that participating individuals are either at risk for, or affected by, a fatal hereditary disease. In addition, the total costs, which would be duplicated by award to a source other than the current Contractor, would be comparable to starting the Roster from its inception. This would include activities such as identifying HD patients and families, developing family history questionnaires, obtaining institutional IRB approval and establishing a presence with the HD research and clinical community. Such a scope of activities would be in access of $1,408,307 based on funds expended during the early developmental stages of the Roster, which spanned the timeframe when the gene for Huntington's Disease was cloned. The loss of time and access to information during this critical period of HD therapeutic development is estimated to be five years. This is a minimum estimate, and the total duplicative expense and the period of delay would likely be much larger. In addition, the personal relationships which have developed between patients and families with Indiana University due to the sensitivity of records cannot be duplicated. 10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition. No other sources have expressed an interest, in writing, in the proposed acquisition. 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. The extension will facilitate the closeout of the National Research Roster of Huntington's Disease Patients and Families (HD Roster) and transfer ownership of the voluntary roster of patients and families affected by Huntington's Disease (HD Roster) to Indiana University. No future acquisition is anticipated. In the event a future requirement of this nature becomes necessary, market research will be conducted. 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 Margaret Sutherland, Ph.D. Project Officer's Immediate Supervisor Emmeline Edwards, Ph.D. Head of the Sponsoring Program Office Story Landis, Ph.D. 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 Contract Specialist Helene Braun 14. Chief of the Contracting Office and Head of the Contracting Activity signature(s). Official Name & Title Signature Date Chief of the Contracting Office Kirkland L. Davis Director, Office of Acquisitions, NIDA James L. Quinn Head of Contracting Activity Diane F. Fraiser 15. Competition Advocate signature. Official Name & Title Signature Date Competition Advocate Walter Schaffer, Ph.D. 16. HHS Senior Procurement Executive signature. Official Name & Title Signature Date HHS Senior Procurement Executive N/A
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NINDS/NIH-NINDS-09-02/listing.html)
Place of Performance: Address: Indiana University, Department of Medical and Molecular Genetics, Division of Hereditary Genomics, Health Information and Translational Sciences Building, 410 West 10th Street, HS 4000, Indianapolis, Indiana, 46202, United States; Zip Code: 46202
Record: SN01980433-W 20091007/091006001042-2937776cba1bc36758cd5d3f78d5b6c8 (fbodaily.com)
Source: FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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A -- National Research Roster of Huntington's Disease for Patients and Families