SOLICITATION NOTICE
R -- Bioanalysis Testing Services for Laboratory Support
- Notice Date
- 6/22/2016
- 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 Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-NOI-2016-440
- Archive Date
- 7/12/2016
- Point of Contact
- Hunter A. Tjugum, Phone: 301 435 8780
- E-Mail Address
-
hunter.tjugum@nih.gov
(hunter.tjugum@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION PURSUANT TO FAR Subpart 5.2-Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT TO ACTION. THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), Station Support Contracts and Simplified Acquisitions Branch (SS/SA) on behalf of the National Institute on Aging (NIA) intends to negotiate and award a contract for Bioanalysis Testing Services for Laboratory Support for NIA Protocol 10-AG-0423, A clinical trial of exendin-4 for the treatment of Alzheimer's disease to the Trustees of the University of Pennsylvania, 3451 Walnut Street, Philadelphia, PA 19104. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541990 with a Size Standard of $15.0 M. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-88-1 / 06-15-2016. STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source. DESCRIPTION OF REQUIREMENT Project Description To determine the safety and tolerability, as well as to acquire preliminary evidence for the effectiveness of twice daily administration of Exendin-4 as a treatment for early-stage Alzheimer s disease or mild cognitive impairment, NIA has lauched into a Pilot Study of Exendin-4 in Alzheimer s Disease. Exendin-4 (or Exenatide) is a medication currently used to treat diabetes, but it has shown promising results in tests of its effectiveness in protecting neurons from damaging processes associated with Alzheimer s disease. It is possible that Exendin-4 may be a treatment for Alzheimer s disease, which involves the gradual deterioration and death of neurons. Researchers are interested in studying the safety and comparing the effects of Exendin-4 with placebo to on congestive performance, overall clinical progression, various chemicals measured in blood and cerebrospinal fluid, and brain MRI, in individuals with early-stage Alzheimer's disease or mild cognitive impairment. (protocol #10-AG-0423 clinicalstudies.info.nih.gov) Purpose and Objectives The pilot clinical study of Exendin-4 in Alzheimer's disease describes a Phase II double-blinded placebo-controlled randomized clinical trial of Exendin-4 in patients with early Alzheimer's disease. Up to 120 participants will undergo screening procedures so that 40 participants will meet eligibility criteria and be enrolled into treatment with Exendin-4 or placebo for 18 months. Screening includes a blood draw to provide plasma and a lumbar puncture to provide cerebrospinal fluid (CSF). Eligibility, among other criteria, is based on the results of cognitive testing and levels of a CSF biomarker of Alzheimer's disease [amyloid beta peptide (Ab1-42)]. Enrolled participants will be followed over a course of 18 months and will return periodically for study visits. Specifically, enrolled participants will return for follow up at 6, 12, and 18 months after treatment initiation. Returning participants will provide plasma in each of the above visits and (optionally) CSF at the final 18 month visit. Period of Performance The period of performance is 12 months from July 2, 2016 through July 1, 2017 with an option to exercise four (4) subsequent option year periods of performance. CLOSING STATEMENT 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 solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. 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 June 27, 2016 at 10:00 AM Eastern and must reference number HHS-NIH-NIDA-SSSA-NOI-2016-440. Responses must be submitted electronically to Hunter Tjugum at hunter.tjugum@nih.gov and must reference the solicitation number on your electronic request. FAX requests are not accepted. 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/NIDA-2/HHS-NIH-NIDA-SSSA-NOI-2016-440/listing.html)
- Record
- SN04157675-W 20160624/160622234201-67570fd5645bd09c8eba3e4b21d45063 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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