SOLICITATION NOTICE
A -- Phenotypic Manifestations of Copy Number Variations (CNV) in 16p11.2, MYT1L, NRXN, 15q13.3 and 22q11.2
- Notice Date
- 1/24/2014
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- 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-NIDA(MH)-14-002
- Archive Date
- 2/25/2014
- Point of Contact
- Bruce E. Anderson, Phone: 301-443-2234, Melissa E. Gluck, Phone: 301-443-2848
- E-Mail Address
-
banderso@mail.nih.gov, melissa.gluck@nih.gov
(banderso@mail.nih.gov, melissa.gluck@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a notice of intent, not a request for proposals. A publically available solicitation document will not be issued and proposals will not be requested. 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 procurement with the Department of Psychiatry, Neuropsychiatry Section at the University of Pennsylvania, 10 Gates Building Philadelphia, PA 19104-4283, entitled "Phenotypic Manifestations of Copy Number Variations (CNV) in 16p11.2, MYT1L, NRXN, 15q13.3 and 22q11.2," 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). BACKGROUND This initiative is part of The Child Psychiatry Branch (CPB) at the National Institute on Mental Health (NIMH), National Institutes of Health (NIH). The mission of the CPB is to conduct research on the diagnosis, treatment, and neurobiology of childhood psychiatric disorders. The Child Psychiatry Branch (CPB) at the National Institute on Mental Health (NIMH), National Institutes of Health (NIH), is interested in the Phenotypic Manifestations of Copy Number Variations (CNV) in 16p11.2, MYT1L, NRXN, 15q13.3 and 22q11.2 in a specific population of subjects identified by the Children's Hospital of Philadelphia (CHOP), Center for Applied Genomics (CAG). Children's Hospital of Philadelphia (CHOP), Center for Applied Genomics (CAG) currently has a study population of 100,000 subjects, ages 0-21, in the Philadelphia area for which all health care records are online and linked to DNA samples. The study group includes healthy and ill subjects. These subjects represent a wide spectrum of diseases and/or conditions (including healthy controls). The DNA from this subject pool is currently being screened for the presence of CNVs in these 5 loci. It is hypothesized that CNVs in these loci can have a broad impact on psychiatric, neurological, immunological, and/or other system-wide or organ-specific functions, leading to a wide range of medical pathologies that have not been fully characterized or previously attributed to mutations at these loci. Findings from this study group may provide proof-of-principle to support other related studies to explore the role of pathogenic CNVs in many other regions (~200 loci) across the full ~150K samples in the CAG repository. The University of Pennsylvania is considered uniquely qualified to perform this work. The University of Pennsylvania and CHOP are both affiliates of the University of Pennsylvania Health System. No sources other than University of Pennsylvania have the required access to the medical records and the subjects from the CHOP subject population. The University of Pennsylvania has been conducting a pediatric population study involving genetic measures and clinical phenotyping of subjects from the CHOP subject pool. However, more data capture and analysis is necessary. In addition, there are no other known existing pediatric populations and associated databases that can be used for this study. The size and geographic diversity of the pediatric database is extensive and unique, as is the ability to generate the research findings on abnormalities in the development of brain circuitry in CNV carriers. Since researchers at the University of Pennsylvania, in collaboration with CHOP, have been granted sole access to the unique subject population and database to be used in this study, they are considered the only group that can perform this Project. Therefore, under the requirements of 41 U.S.C. 253[c](1) and FAR 6.302-1, University of Pennsylvania is the only source capable of meeting the requirements of this project. PURPOSE AND OBJECTIVES The NIMH intends to issue a new, non-competitive contract, to the University of Pennsylvania to conduct follow-up studies in a broad group of patients with CNVs identified by the Children's Hospital of Philadelphia (CHOP). This Contract will collect additional data and analysis from subjects screened by Children's Hospital of Philadelphia to further identify the range of phenotypic manifestations caused by pathogenic copy number variations (CNVs) arising from deletion or duplication of the 16p11.2-16p12.2 region, 22q11.2 and deletions of part or all of the MYT1L,15q13.3 and NRXN genes. PROJECT REQUIREMENTS Independently, and not as an agent of the federal Government, the Contractor shall furnish, as needed to perform the work set forth herein, all necessary labor (qualified and experienced personnel), services, equipment, materials, supplies, and facilities, except as otherwise specified herein. The Contractor shall: (1) Identify/select ~150 appropriate subjects for this Study, as approved by the COR, by examining screening data provided by the University of Pennsylvania from a current CHOP pediatric population study involving genetic measures and clinical phenotyping; (2) Provide follow-up characterization of the selected subjects, involving, but not limited to, the following procedures: (a) Structured diagnostic psychiatric interviews utilizing the K-SADS for children and adolescents, and C_GAS for overall level of functioning; (b) Neurocognitive testing measuring: executive, general cognition, social cognition, and working memory; (c) Current medical status for all systems; (3) Evaluate the reliability and validity of these measures; (4) Report the findings on a quarterly basis, and the final data on 150 subjects in a Final Report; (5) Follow the NIH clinical practice regulations in performance of this contract: http://grants.nih.gov/grants/policy/hs/index.htm http://clinicalresearch.nih.gov/ethics_guides.html. REPORTS/DELIVERABLES The following reports will be required: (1) The Contractor shall provide quarterly reports on subjects evaluated, to include the following measures: (a) Rating Scale of Symptoms Item and summary scores from rating scales and interviews listed above; (b) Clinical Interview Summaries; (c) Cognitive Battery Test Scores; (d) Anatomical and Functional Brain imaging data when available; (2) A Final Contract Report summarizing all 150 cases for the above measures. All reports shall be submitted in electronic form as PC-formatted computer files in Microsoft Word and Microsoft Excel and/or searchable PDF format. ANTICIPATED PERIOD OF PERFORMANCE The anticipated period of performance is three (3) years from approximately July 1, 2014 through July 1, 2017. OTHER IMPORTANT CONSIDERATIONS The North American Industry Classification System (NAICS) Code is 541711, 500 employees. GENERAL INFORMATION This is a Pre-solicitation Notice in advance of intended solicitation for an intended contract with The University of Pennsylvania. This notice of intent is NOT a request for competitive proposals. There is no solicitation package available. However, the Government shall consider all written responses received to this Notice. 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-NIH-NIDA(MH)-14-002 and may be submitted electronically no later than 4:30 P.M. Eastern Standard Time, February 10, 2014, to the Contracting Officer, Bruce E. Anderson at: banderso@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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIMH/HHS-NIH-NIDA(MH)-14-002/listing.html)
- Record
- SN03273718-W 20140126/140124234006-3ca2f34b197c7765c6c32b3f9a7f1f15 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |