SOLICITATION NOTICE
66 -- eGMP Gallium 68 Generator
- Notice Date
- 9/14/2016
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- 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
- HHS-NIH-NHLBI-CSB-(HG)-2016-319-DM
- Archive Date
- 10/6/2016
- Point of Contact
- Dorothy Maxwell, Phone: 301-435-0352
- E-Mail Address
-
maxwelld@mail.nih.gov
(maxwelld@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- (i) "This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued." (ii) The solicitation number is HHS-NIH-NHLBI-CSB-(EB)-2016-319-DM and the solicitation is being posted as a request for proposal (RFP) to procure: eGMP Gallium 68 Generator on behalf of National Institutes of Health, National Institute of Biomedical Imaging and Bioengineering (NIBIB). (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-89-1, August 15, 2016. (iv) This is NOT a Set-Aside, the associated NAICS Codes: 325412, Pharmaceutical Preparation Manufacturing and small business size standards is 1250. The acquisition is being conducted in accordance with the procedures of FAR Part 12 and FAR Part 13. All responsible offerors may submit a proposal, which if timely received, shall be considered by the agency. Offers are due by 7:30 A.M. Eastern Time (EST) on September 21, 2016. Proposals can be emailed to the Contracting Officer, Dorothy Maxwell, Contracting Officer at maxwelld@mail.nih.gov, place Solicitation Number: HHS-NIH-NHLBI-CSB-(EB)-2016-319-DM on the quotation. ( v) Background : The National Institutes of Health (NIH) mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The National Institute of Biomedical Imaging and Bioengineering (NIBIB), is dedicated to improving human health through the integration of the physical and biological sciences. The research agenda of the NIBIB will dramatically advance the Nation's health by improving the detection, management, understanding, and ultimately, the prevention of disease. NIBIB's mission is not limited to a single disease, group of illnesses, or population; rather it spans the entire spectrum. We work with doctors from every field of medicine and bring together teams of scientists and engineers from many different backgrounds to develop innovative approaches to health care. The Laboratory of Molecular Tracer and Imaging Core Facility, the PET Radiochemistry and Imaging Core Facility develops novel methods for incorporating radionuclides and fluorophores into molecules for the study of biologically important processes. All of the projects are in support of principal investigator-initiated research. NIBIB seek to collaborate with clinical and biological investigators who share our goal of providing new imaging tools for clinical studies and the study of biological processes. NIBIB research efforts are driven by a desire to improve understanding of human biology and disease and to generate tools that have clinical application. Probes have been produced with applications to many important biological processes, including inflammation, metabolism, proliferation, angiogenesis, metastasis, lymphogenesis, and apoptosis. Purpose and Objectives : The Laboratory of Molecular Tracer and Imaging Core Facility, NIBIB conducts research in the field of radiochemistry for the purpose of developing novel radiolabeled compounds for use in positron emission tomography (PET). Gallium-68 is a positron-emitting radionuclide with a 68 min half-life that is well suited to many PET applications. Its utility relies on the ability to prepared biochemically interesting molecules that are modified to contain an appropriate chelator for the Ga-68 metal nuclide. LOMIN has the capability for preparing appropriate biochemical tracers for use with Ga-68. Ga-68 is obtained from decay of Ge-68 (half-life 270 days). This procurement is for a generator for the production of Ga-68. The parent Ge-68 is trapped on a matrix in the generator. As Ge-68 decays, researchers can chemically elute the desired Ga-68 while leaving the Ge-68 on the matrix. In this manner, researchers can obtain more Ga-68 by waiting for the decay and eluting at a later point. This generator allows easy access to Ga-68 for researchers needs and will be useful for about 1 year before it will need to be replaced. The protocols for handling this radionuclide have been established for metal complexation to peptides, proteins, and other biological molecules and the protocols are unique to this generator, any such change could disrupt the research studies. The parent radionuclide is captured on a tin dioxide column and elution utilizes 0.6M hydrochloric acid. Procurement: 1. eGMP Gallium 68 Generator; and 2. Shipping Anticipated Period of Performance : Base Year: 12 Months Option 1: 12 Months Option 2: 12 Months vi. Include on the RFP, Contractor's Name, Contractor's Address, DUNS, TIN or EIN Number, Solicitation Number, Email Address, Contact Number, Discount, Deliverables. vii. The FAR Provision 52.212-1, Instructions to Offerors -- Commercial, applies to this acquisition and is hereby incorporated by reference. All Federal Acquisition Regulations (FAR) clauses may be viewed at http://acquisition.gov/comp/far/index.html. Evaluation of Proposals: The Government will evaluate proposals that are determined technically acceptable in accordance with the Technical Evaluation factors. The Government intends to award a single contract from this solicitation. The Government reserves the right not to award a contract. Evaluation of Proposals: The Government reserves the right to make an award without discussions based solely upon initial proposals. Price (This will be Firm-Fixed Price): An evaluation of the offeror's price proposal will be made to determine if proposed prices are realistic for the work to be performed, reflect a clear understanding of the requirements, and are consistent with the technical proposal. Reasonableness determinations will be made by determining if competition exists, by comparing proposed prices with established commercial or GSA price schedules (if applicable), and/or by comparing proposed prices with the Independent Government Cost Estimate (IGCE). viii. The FAR Provision 52.212-1, Instructions to Offerors -- Commercial, applies to this acquisition and is hereby incorporated by reference. All Federal Acquisition Regulations (FAR) clauses may be viewed at http://acquisition.gov/comp/far/index.html. The proposal must reference the RFP Number: HHS-NIH-NHLBI-CSB-(EB)-2016-317-DM. All responsible offerors may submit a proposal, which if timely received, shall be considered by the agency. All proposals shall contain the following: 1. Name of Contracting Organization; 2. Solicitation number; 3. Contract Type; 4. Total Contract Value and Discounts; 5. Description of Requirement; 6. North American Industry Classification System (NAICS) Code; and 7. DUNS, TIN or EIN Number. x. In accordance to FAR clause 52.212-2, Evaluation - Commercial Items xi. In accordance with FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items, offerors must complete annual representations and certifications on- line at https://www.sam.gov/portal/public/SAM/. xii. FAR clause 52.212-4, Contract Terms and Conditions - Commercial Items applies to this acquisition. xiii. FAR clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items applies to this Acquisition. Additional FAR Clauses include: FAR clause 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUL2013) (Pub.L. 109-282) (31 U.S.C. 6101 note). FAR clause 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (AUG2011). FAR clause 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). FAR clause 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (JUL2013) (31 U.S.C. 3332). xiiii. There are no additional contract requirement(s) or terms and conditions (such as contract financing arrangements or warranty requirements) determined by the contracting officer to be necessary for this acquisition and consistent with customary commercial practices. xv. The Defense Priorities and Allocations System (DPAS) and assigned rating does not apply to this acquisition. xvi. All responsible offerors may submit a proposal, which if timely received, shall be considered by the agency. Offers are due by 7:30 A.M. Eastern Time (EST) on September 21, 2016. Proposals can be emailed to the Contracting Officer, Dorothy Maxwell at maxwelld@mail.nih.gov, place Solicitation Number: HHS-NIH-NHLBI-CSB-(EB)-2016-319-DM on the quotation. Quotations shall not be deemed received by the Government until the quotation is entered into the e-mail address inbox set forth above. Faxed proposals will NOT be accepted. Offerors' proposals shall not be deemed received by the Government until the proposal is entered into the e-mail address inbox set forth above. Offerors must complete annual representations and certifications on-line at https://www.sam.gov/portal/public/SAM/.
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