SOLICITATION NOTICE
R -- Scientific Support Services
- Notice Date
- 9/8/2017
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- HHSN26817HL00049S
- Archive Date
- 10/3/2017
- Point of Contact
- Jonathan M. Lear,
- E-Mail Address
-
john.lear@nih.gov
(john.lear@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction This is a pre-solicitation non-competitive (notice of intent) synopsis to award a purchase order without providing for full and open competition. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA) intends to negotiate and award a purchase order on a noncompetitive sole source basis to George Washington University, 2121 I St. NW, Suite 601, Washington, DC 20052 to provide scientific support services to the NHLBI Division of Intramural Research (DIR) in accordance with the following information. Background Information Li-Fraumeni Syndrome (LFS) is a highly penetrant, autosomal dominant cancer predisposition syndrome that typically manifests prior to age 45. It is estimated that 60-80% of LFS families have detectable germline mutations in TP53. The NHLBI Division of Intramural Research (DIR) recently reported evidence of increased oxidative mitochondrial metabolism both in humans with LFS and in a mouse model of LFS. There is growing evidence that mitochondria play an important role in tumorigenesis, and another site of action of metformin is the mitochondria, where it inhibits complex I of the respiratory chain and increases cellular levels of AMP by inhibiting oxidative phosphorylation. Metformin can modulate the balance between glycolytic and oxidative phosphorylation pathways that are also regulated by TP53. Wild-type p53 promotes growth arrest during cellular stress but mutations in TP53 may cause loss of this inhibitory function, allowing cellular proliferation to progress unchecked. Inhibition of mitochondrial function by metformin in such a setting may induce an energy crisis and result in cell death. In DIR's ongoing phase I pilot study of metformin treatment in LFS patients (NCI 14-C-0005, Walcott, F et al), DIR has preliminary evidence of in vivo and in vitro oxidative metabolism inhibition that serves as proof of concept that it is possible to modulate mitochondrial function in humans. Whether this alteration in metabolic function can prevent or delay cancer development in the LFS patient population remains to be determined. Purpose and Objectives The DIR proposes to launch a phase II, randomized, placebo controlled trial examining the efficacy of metformin in cancer prevention in LFS patients who will receive periodic whole-body MRI, brain, and breast MRI, for cancer screening and metabolic biomarker surveillance. DIR is launching a phase II, double-blinded, randomized, placebo controlled trial with metformin to determine if treatment with metformin decreases the incidence of cancer in patients with germline TP53 mutations and a clinical diagnosis of Li-Fraumeni Syndrome. Contractor Requirements The contractor shall coordinate all aspects of the clinical trial with collaborating centers. The contractor shall coordinate purchase of metformin and placebo and clinical trial coordination. The contractor shall also coordinate serum insulin and insulin related biomarker assays and metabolomics assays with relevant subcontractors and storage of these samples on site. The contractor shall also provide the following -Coordinate and prepare mailing lists and labels and questionnaire -Design and employ data tracking system at FHS for outgoing and returned materials -Provide postage for both outgoing and return mailer and man power to execute the bulk mailing -Provide data collation and data entry of the bulk returned questionnaire -Data cleaning of electronic data -Returned ID's agree with exam dates -Attend/Coordinate Meetings with Team NHLBI Period of Performance The period of performance will be twelve (12) months from date of contract award. Sole Source Justification The sole source determination is because Dr. Paul Hwang (of NHLBI) and his collaborator Dr. Farzana Walcott (of George Washington University) were recipients of an NIH Bench to Bedside (B2B) award for the study described in this notice. As such, only George Washington University has the capability to meet the Government's need in performing this study. Regulatory Authority This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b) Soliciting from a single source. (1) For purchases not exceeding the simplified acquisition threshold, contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, or industrial mobilization). FAR Clauses The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. The provision at FAR clause 52.212-2, Evaluation - Commercial Items, is applicable. The Government will award a contract resulting from this notice to the offeror listed above. The following factors shall be used to evaluate the offer: The contractor shall demonstrate its ability to provide the above listed equipment that meet the required specifications listed. FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items, is applicable. An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (p) of this provision. FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items, applies to this acquisition. Additional Information The North American Industry Classification System (NAICS) Code is 541990 and the Small Business Size Standard is $15.0M. This acquisition is being conducted under FAR Part 13, Simplified Acquisition Procedures, therefore the requirements of FAR Part 6, Competitive Requirements, are not applicable and the resultant award will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-95 (January 19, 2017). This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. 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. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by September 18, 2017 at 10:00AM EST and must reference synopsis number HHSN26817HL00049S. Responses shall be submitted electronically to john.lear@nih.gov. Responses will only be accepted if dated and signed by an authorized company representative. All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHSN26817HL00049S/listing.html)
- Place of Performance
- Address: National Institutes of Health / NHLBI, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04669635-W 20170910/170908232535-94e9bff813626f50113172f9998d6684 (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 |