SPECIAL NOTICE
A -- Notice of Intent to Award Sole Source Modification to The Lewin Group for Study of Health Outcomes in Children with Autism and Their Families
- Notice Date
- 1/24/2013
- Notice Type
- Special Notice
- 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-N-271-2010-00033-C
- Archive Date
- 2/23/2013
- Point of Contact
- Suzanne Stinson, Phone: 301 443 4116
- E-Mail Address
-
sstinson@mail.nih.gov
(sstinson@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- SPECIAL NOTICE: Pre-Solicitation Notice Reference Number: HHS-N-271-2010-00033-C Title: Notice of Intent to Award Sole Source Modification to The Lewin Group for Study of Health Outcomes in Children with Autism and Their Families The National Institute on Drug Abuse (NIDA), Office of Acquisitions - Neurosciences, National Institute of Mental Health (NIMH)/National Institute on Aging (NIA) Research and Development Contracts Management Branch (R&D CMB), on behalf of the NIMH, intends to negotiate a modification to an existing contract on a sole source basis pursuant to 41 U.S.C.253(c)(1) as implemented by FAR 6.302-1 (Only one responsible source and no other services will satisfy agency requirements) with: The Lewin Group 3130 Fairview Park Drive, Suite 800, Falls Church, VA 22042 BACKGROUND Autism Spectrum Disorder (ASD) is a significant public health concern, with an estimated prevalence of 1 in 88 children in the United States. Much of the research to date has focused on the core social and communication deficits of ASD, but there are anecdotes and some survey data suggesting that the rate of comorbid health conditions may also be elevated in this population. Furthermore, despite several large-scale epidemiological studies that have assessed but not found any potential association between ASD and vaccinations, public concerns persist about such a causal link. At least partly as a consequence, health officials in the United States have reported an increased rate of vaccine refusal in the general population. "Study of Health Outcomes in Children with Autism and Their Families" awarded on a competitive basis on 09/20/2010 to The Lewin Group under Contract # HHSN271201000033C, is a cost-reimbursement research and development type contract, and currently expires on February 15, 2013. Under this contract, The Lewin Group analyzed a large dataset of retrospective commercial health plan claims of 46,236 children with ASD, their parents and siblings, and a comparison cohort of children and family members. They successfully completed the analyses requested in the original statement of work, which included a study of the validity of ASD diagnoses in the claims data, and descriptions of health outcomes and health care utilization of the ASD cohort, their family members, and the comparison cohorts. The purpose of this contract modification is to conduct additional analyses on the extent of vaccination coverage and health outcomes of the younger siblings of children with ASD and younger siblings of the comparison cohort, and examine the relationships between health outcomes and vaccine history. The basis for the sole source determination: The Lewin Group is uniquely qualified to perform this work. The size and geographic diversity of their proprietary administrative database is unique, as is the ability to link medical, pharmacy, and behavioral coverage, and family members. A validation study of ASD diagnoses has already been conducted with the claims data. About 60% of the resources of the original contract were used to obtain the necessary administrative permissions to use the databases, conduct the validation study of the ASD diagnoses, link the appropriate data sources, determine the cohort with adequate continuous coverage, and determine the study variables. Thus, significant federal resources have been used to develop this unique database, and the questions now on the table are directly related to prior analyses using this data. An attempt to solicit the same analyses from another source would result in a duplication of effort, expending significantly more funding and time. A new contractor would be unable to meet the same efficiency levels that The Lewin Group has established at this stage of completion of the study. Under the requirements of 41 U.S.C. 253[c](1) and FAR 6.302-1, The Lewin Group is the only source capable of meeting the requirements of this project. PURPOSE AND OBJECTIVES The purpose of this proposed action is to extend the Contract's current period of performance an additional 12 months, and, provide for follow up of previous findings with additional analyses using a proprietary database derived and validated under the contract. PROJECT REQUIREMENTS Specifically, the contract modification will address the following: (a) The extent of vaccination in younger siblings of children with ASD and the comparison cohort; and (b) The health outcomes in younger siblings of the children with ASD and the comparison cohort, with respect to medical and neuropsychiatric disorders (including ASD), including relationship of these outcomes to vaccine history. REPORTS/DELIVERABLES All reports shall be submitted in electronic form as PC-formatted computer files in Microsoft Word and Microsoft Excel and/or searchable PDF format. The following reports will be required: A. Quarterly Technical Progress Reports, the contractor shall provide a report no later than the 30th calendar day of the month in which the quarter ends (e.g. May 30, 2013, August 30, 2013, etc.); B. Annual Progress Reports, the Contractor shall provide the Contracting Officer (CO) with two copies of the Annual Progress Report in draft form in accordance with the DELIVERIES Article in SECTION F of the Contract/10 Calendar days prior to the delivery date for the Final Version of the Annual Report. The Contracting Officer's Representative (COR) will review the draft report and provide the CO with comments within 5 calendar days after receipt. The Annual Progress Report shall be corrected by the Contractor, if necessary and the final version delivered as specified in the above paragraph. C. Final Progress Report and Summary of Salient Results, a final report shall be submitted on or before the last day of the period of performance. This report shall include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to explain comprehensively the Tasks accomplished and the results achieved, and shall summarize data and statistical analyses performed in text, tabular and graphical form. D. Other Reports and Deliverables: 1. Data File Turnover Report, an electronic and hardcopy report is required by completion date of contract; 2. Data Sharing (National Database for Autism Research (NDAR) data entry, an electronic and hardcopy report is provided upon request by COR; 3. Small Business Subcontracting Plan, an annual report is due (see http://www.esrs.gov); 4. Contractor-Employee non-Disclosure Agreement(s), an electronic and hardcopy report is applicable before an employee begins work; 5. Updated IT Security Plan (in accordance with NIST SP 800-26 Security Self Assessment Guide), an electronic and hardcopy is due annually with the corresponding quarterly progress report; 6. Information Security Training Report, an electronic and hardcopy is to be included with original and subsequent revisions with each technical progress report; 7. Section 508 Annual Report (as applicable), an electronic and hardcopy is due annually with the corresponding annual progress report and with the final technical progress report; and 8. Annual and Final Invention Disclosure Reports, an electronic and hardcopy is due in accordance with FAR Clause 52.227-11, Patent Rights-Ownership by the Contracting, with annual and final technical reports. ANTICIPATED PERIOD OF PERFORMANCE The anticipated period of performance is one 12-month performance year from 2/16/2013 through 2/15/2014. OTHER IMPORTANT CONSIDERATIONS (1) The North American Industry Classification System (NAICS) Code is will be 541720; (2) The Contractor must use the dataset developed for and used for the Study of Health Outcomes in Children and Autism and Their Families Study. Because the Lewin Group is the sole proprietor of the larger database of commercial health claims data, access to the database from which the dataset is derived is limited. The database is unique in its size and geographic diversity; (3) A validation study of the Autism Spectrum Disorders (ASD) diagnoses has already been completed by the Contractor; (4) To answer further questions, the current data source has to be used; any other potential sources would not have access rights to the database, and, would have to duplicate the effort already expended under the current existing contract with Lewin to develop and validate a database, as well as to duplicate the already-completed analyses of health outcomes and health care service use. This would result in significant additional and duplicative costs to the Government, and, significant delay delivery of the final research findings. GENERAL INFORMATION This is a Presolicitation Notice in advance of intended solicitation for modification to existing contract to The Lewin Group. This notice of intent is NOT a request for competitive proposals. There is no solicitation package available. However, the Government shall consider all responses received within fifteen (15) days of this posting. Interested parties may identify their interest and capability to respond to the requirement, in writing no later than the response date. Written responses to this notice shall contain sufficient documentation to establish a bona fide capability to fulfill the requirement. Written responses shall reference this Notice of Intent No. HHS-N-271-2010-00033-C and may be submitted electronically NO LATER THAN 4:30 P.M. EASTERN STANDARD TIME February 8, 2013 to the Contracting Officer, Suzanne Stinson at sstinson@mail.nih.gov. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Written responses to this synopsis shall contain sufficient documentation to establish a bonafide capability to fulfill this requirement. The Government will not be responsible for any costs incurred by interested parties in responding to this notice.
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