Purchase of Brand Name Biohit H. pylori antibody assay kits, or equal

This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice and under the authority to use simplified procedures for commercial requirements as provided in FAR 13.5. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation: No. N02CP66002-63 includes all applicable provisions and clauses in effect through FAR FAC 2005-89 (August 15, 2016). This requirement is a small business set aside. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. Objective The purpose of this requirement is to purchase Brand Name or equal Biohit H. pylori antibody assay kits to test baseline samples collected from participants in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) study. Background Helicobacter pylori infection is the strongest known risk factor for gastric cancer, which disproportionately affects Hispanic populations in the U.S. and Latin America. Hispanics from Mexico and Puerto Rico have gastric cancer incidence rates 2.2 and 3.6 times that of non-Hispanic whites, while Hispanics from South or Central America have rates 4.3 to 5.1 times higher. Findings from NHANES suggest that age-standardized H. pylori seroprevalence remains higher in Mexican Americans than in non-Hispanic whites. Differences in H. pylori seroprevalence are not explained by socioeconomic factors alone and suggest factors such as age at migration to the U.S. and degree of acculturation may influence seropositivity and subsequent gastric cancer risk. Based on questionnaire data and standardized spirometry, the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) study reported that asthma was more prevalent among Puerto Ricans, other Hispanics born in the U.S., and those who had immigrated as children than among other Hispanics. Previous epidemiologic studies have reported a protective effect of H. pylori infection on development of asthma using self-reported status. It has been reported genome-wide associations of high levels of anti-H. pylori antibodies with variants in the toll-like receptor locus at 4p14. NCIs replication study in the ATBC Study confirmed the association with high antibody levels but not with seropositivity overall, supporting a novel interpretation that these variants may be linked to host immune response to H. pylori rather than to acquisition of infection per se. Using available genotyping data , the proposed GWAS will help NCI to identify potential genetic protection in this setting of high H. pylori infection pressure encountered by Hispanic populations. The H. pylori results generated by this service will be used to achieve the following research aims: 1) To determine the seroprevalence of H. pylori infection and its risk factors 2) To evaluate the association between H. pylori infection and spirometric diagnosis of asthma. 3) To conduct a genome-wide association study (GWAS) for anti-H. pylori antibodies\ Contractor Requirements The Contractor shall provide 178 Brand Name or equal Biohit kits to detect anti-H. pylori antibodies. The contractor shall certify that the entire lot of reagents will generate consistent results and remain suitable for use for at least 12 months. The contractor shall ship the H. pylori antibody assay kits to the testing laboratory at the direction of the NCI Principal Investigator. Government Responsibilities The Government will be responsible for coordinating acceptance of the H. pylori antibody assay kits at the testing laboratory. The Government will confirm that package labeling and/or accompanying documentation satisfy the consistency and expiration requirements listed above prior to final acceptance. Period of Performance Service shall be carried no later than 6 months after date of award. Payment Payment will be made after satisfactory completion and acceptance of services provided. PROVISIONS AND CLAUSES: The following Federal Acquisition Regulation and Health & Human Services Acquisition Regulation Provisions/Clauses apply to this acquisition: FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): http://www.acquisition.gov/far/ and/or http://www.hhs.gov/policies/hhsar/. FAR 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (OCT 2015) FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS (NOV 2015) FAR 52.212-4 CONTRACT TERMS AND CONDITIONS-COMMERCIAL ITEMS (MAY 2015) FAR 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (MAR 2016). The following FAR clauses cited in paragraph (b) of the clause at FAR 52.212-5 are also applicable to this acquisition: FAR Clause 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards. FAR Clause 52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. FAR Clause 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns. FAR Clause 52.219-6, Notice of Total Small Business Aside FAR Clause 52.219-13 Notice of Set Aside Orders FAR Clause 52.219-28 Post Award Small Business Program Representation. FAR Clause 52.222-3 Convict Labor. FAR Clause 52.222-19 Child Labor-Cooperation with Authorities and Remedies FAR Clause 52.222-21 Prohibition of Segregated Facilities. FAR Clause 52.222-26 Equal Opportunity. FAR Clause 52.222-36 Affirmative Action for Workers with Disabilities FAR Clause 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving. FAR Clause 52.225-13 Restrictions on Certain Foreign Purchases FAR Clause 52.232-33 Payment by Electronic Funds Transfer-System for Award Management. FAR Clause 52.247-64 Preference for Privately Owned U.S.-Flag Commercial Vessels. FAR 52.211-6 Brand Name or Equal (AUG 1999) (a) If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government's needs. The salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation. (b) To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must- (1) Meet the salient physical, functional, or performance characteristic specified in this solicitation; (2) Clearly identify the item by- (i) Brand name, if any; and (ii) Make or model number; (3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and (4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications. (c) The Contracting Officer will evaluate "equal" products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer. (d) Unless the offeror clearly indicates in its offer that the product being offered is an "equal" product, the offeror shall provide the brand name product referenced in the solicitation. The award decision will be based on a Lowest Price Technically Acceptable (LPTA) determination. Award will be made on all or none basis. A technically acceptable quote is one that meets the requirements stated above. Quotations must be received in the NCI-OA contracting office by 4:00 PM. ET on September 15, 2016. Please refer to solicitation number N02CP66002-63 on all correspondence. No collect calls will be accepted. Quotations shall be emailed to Seena Ninan, Contracting Officer at seena.ninan@nih.gov. All questions shall be in writing and may be addressed to the aforementioned individual noted above and shall be received by 12:00 p.m. ET on September 14, 2016. No collect calls will be accepted. In order to receive an award, contractors must be registered in the System for Award Management through sam.gov and have complete Representations and Certifications at sam.gov or provide a copy to the aforementioned individual prior to award.