Special_Notice_Univ_of_Missouri_FBO,_75N91019Q00114.pdf

Document Title: Identification of Radiation-Injury Markers to Predict Organ Damage and Survival after Whole-Body Irradiation in Mouse and Minipig Models

Document Type: Special Notice

Solicitation Number: 75N91019Q00114

Proposed Posted Date: September 4, 2019

Proposed Response Date: September 6, 2019

Classification Code: B - Special Studies and Analysis – not R & D

NAICS Code: 541990 - All Other Professional, Scientific and Technical Services

Business Size Standard: $15.0 million

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E126, Bethesda, MD

20852, UNITED STATES.

1.0 Description

The National Cancer Institute (NCI), Center for Cancer Research (CCR), Radiation Oncology Branch (ROB), Experimental Therapeutics Section (ETS) plans to procure on a sole source basis services for the identification of radiation-injury markers to predict organ damage and survival after whole-body irradiation in mouse and minipig models from Gryphon Scientific, LLC, Gryphon Scientific, LLC, 1 Halfyard Drive, Brookline, New Hampshire 03033.

This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1) and is exempt from the requirements of FAR part 6.

Only one award will be made as a result of this solicitation. This will be awarded as a Severable, Firm Fixed Price type contract.

The services acquired under this contract are severable services. Funds are only available for use for the contract line item (CLIN) to which they are obligated. Unused funds from one CLIN may not rollover for use in other periods.

The North American Industry Classification System code is 541990 and the business size standard $15.0 million.

It has been determined there are no opportunities to acquire green products or services for this procurement.

2.0 Background

Pancreatic adenocarcinoma (PDA) is among the most fatal cancers worldwide and one for which there are few established preventable risk factors beyond cigarette smoking, diabetes, and overweight and obesity. The effect of other exposures is unclear mostly due to inconsistent findings. The lack of identification of consistent risk factors likely reflects the methodological difficulties including reverse causation as well as selection, survival, recall and surrogate reporting biases associated with collecting data for this rapidly fatal gastrointestinal cancer.

Prospective studies do not have these problems.

Few studies have evaluated trace elements and risk of pancreatic cancer in non-occupational cohorts. Limitations of these studies were the small number of pancreatic cancer cases and/or the cases were from retrospective studies that may have issues with reverse causation.

The Metabolic Epidemiology Branch (MEB), Division of Cancer Epidemiology and Genetics (DCEG), of the National Cancer Institute (NCI) is conducting a study to determine whether trace elements are associated with pancreatic cancer. Elements shall be measured prospectively in blood samples (either whole blood or red blood cell (RBC) samples) from pancreatic cancer cases and non-cases.

3.0 Scope

Utilizing a nested case-control design within the Prostate, Lung, Colorectal, and Ovarian Cancer Trial cohort, this project shall examine the association between blood concentrations of trace (i.e.

Cu, Zn, Fe, Mg) and ultra-trace (i.e. Cd, Cr, Pb, As, Hg) elements and risk of pancreatic cancer.

The elements shall be measured on incident pancreatic cancer cases and controls (238 cases, 476 controls, 71 blinded QC samples, total 785 samples) using inductively coupled plasma mass spectrometry (ICP-MS).

4.0 Contractor Requirements

The Contractor shall:

4.1 Store samples immediately after shipment is received from the NCI in -80 degrees until ready for assays. The NCI will ship the samples to the Contractor within 30 days from the effective start date of award;

4.2 Measure blood concentrations of trace (i.e. Cu, Zn, Fe, Mg) and ultra-trace (i.e. Cd, Cr, Pb, As, Hg) elements using whole blood or RBCs. The sample volume required is 350 µL. Three subsamples shall be prepared from the original volume for the analysis. The first subsample of 300 µL shall be diluted 1:10 with 2% HNO3 and 1% butanol. This sample shall be analyzed for Cr, Cd, Pb, As, and Co using a Perkin Elmer 300X inductively coupled plasma mass spectrometer (ICP-MS) in kinetic energy discrimination (KED) with He flow rates up to 6.25 L/min. The second subsample of 25 µL shall be diluted 1:300 with 2% HNO3 and analyzed for Fe, Cu, Zn, Mg, and Ca using ICP-MS with KED with He flow rates up to 4 L/min. The third subsample of 25 µL shall be analyzed using a Nippon MA-3000 direct thermal combustion mercury analyzer (DMA). The samples shall be analyzed in batches of 90 samples for the ICP-MS analysis and 30 samples for the DMA analysis. Each sample batch shall include analytical method blanks, Seronorm™ and National Institute of Standards and Technology (NIST) quality control materials;

4.3 The boxed samples shall be sent in batches of 30 to accommodate both the 30 sample and 90 sample batch sizes above. All batches and samples within the batches shall be assayed in the order provided by the NCI. All samples shall be sent at the same time. All analytical work performed by the Contractor shall be conducted under conditions of careful quality control and shall follow the laboratory’s quality control procedures. All Contractor internal quality control charts shall be provided to the NCI after the first batch and at completion of the work. The NCI shall review the data for the blinded quality control samples to assure that satisfactory reproducibility is being provided.

4.4 The Contractor shall notify the NCI TPC immediately via e-mail or phone call if any unusual problems develop over the course of the project and/or explanations for repeating analyses, such as failure of analytical and quality control procedures, breakdown of freezers, instrumentation and equipment, and major changes in personnel that would produce delays or that would adversely influence the quality of the laboratory performance.

4.5 After the assays are run on each batch, residual samples shall be stored in the laboratory at -80 degrees Centigrade. All biological materials provided by the U.S. Government, all residual specimens, and all data generated shall be the property of the U.S. Government and shall be returned to the U.S. Government repository via FedEx after the assays are completed and data approved by NCI TPC.

6.0 Period of Performance

The period of performance shall be for a one 12-month base period with two, 12-month optional periods as follows:

Base Period September 30, 2019 – September 29, 2020 Option Period 1 September 30, 2020 – September 29, 2021 Option Period 2 September 30, 2021 – September 29, 2022

5.0 Place of Performance

All assays shall be performed at the Contractor’s facilities.

All deliverables shall be returned to the U.S. Government Repository via FedEx at the following address:

4600 Wedgewood Blvd, Ste H Frederick, MD 21703-7167 POC: Karen Drew Phone: 301-694-5911

7.0 Report(s)/Deliverables and Delivery Schedule

The Contractor shall complete the following tasks in section 4.0 in the Base Period, Option Period 1 and Option Period 2.

Measurement of the trace and ultra-trace elements as a dataset in tables which contains the identification number of each participant (or quality control sample) and the quantified levels, including units, of all serology quantitation data from the ICP-MS assays, within one month of completing the measurements. This data shall be delivered by email to the NCI TPC in an accessible format such as .xlsx or .csv.

Deliver data to the NCI TPC as tables of trace and ultra-trace element concentrations. This will be delivered by e-mail as either an Excel file or text file.

DELIVERABLE DELIVERABLE DESCRIPTION / FORMAT

REQUIREMENTS DUE DATE

4.2

Measurement values of blood concentrations of trace (i.e. Cu, Zn, Fe, Mg) and ultra-trace (i.e. Cd, Cr, Pb, As, Hg) elements using whole blood or RBCs of elements on 785 samples by ID in an excel file

60 days before end of award

4.3

Samples within each batch will be run consecutively and each batch will be run in full.

All batches and samples within the batches shall be assayed in the order provided by the NCI. All samples shall be sent at the same time. All analytical work performed by the Contractor shall be conducted under conditions of careful quality control and shall follow the laboratory’s usual quality control procedures. All Contractor internal quality control charts shall be provided to the NCI after the first batch and at completion of the work.

The NCI shall review the data for the blinded quality control samples to assure that satisfactory reproducibility is being provided.

60 days before end of award

4.5

After the assays are run on each batch, residual samples shall be immediately stored in the laboratory at -80 degrees Centigrade. All biological materials provided by the U.S.

Government, all residual specimens, and all data generated shall be the property of the U.S.

Government and shall be returned to the U.S.

Government repository via FedEx after the assays are completed and data approved by NCI TPC.

30 days after the assays are completed

8.0 CLAUSES

Section 508 Compliance

Training material guidelines of the revised 508 Standards apply as follows:

E.205 Electronic Content

E205.3 Agency Official Communication. Electronic content that is not public facing shall conform to the accessibility requirements specified in E205.4 when such content constitutes official business and is communicated by an agency through one or more of the following:

A. An emergency notification;

C. An internal or external program or policy announcement;

D. A notice of benefits, program eligibility, employment opportunity, or personnel action;

E. A formal acknowledgement of receipt;

H. Educational or training materials; or I. Intranet content designed as a Web page.

EXCEPTION: Records maintained by the National Archives and Records Administration (NARA) pursuant to Federal recordkeeping statutes shall not be required to conform to the Revised 508 Standards unless public facing.

E205.4 Accessibility Standard. Electronic content shall conform to Level A and Level AA Success Criteria and Conformance Requirements in WCAG 2.0 (incorporated by reference, see 702.10.1).

See the details at https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines#E205-content

Electronic and Information Technology Accessibility, Section 508 Compliance is applicable to this notice and the following information is provided to assist:

Electronic and Information Technology Accessibility, HHSAR 352.239-73(a)

(January 2010)

a. Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that, unless an exception applies, all EIT products and services developed, acquired, maintained, or used by any Federal department or agency permit--

1. Federal employees with disabilities to have access to and use information and data that is comparable to the access and use of information and data by Federal employees who are not individuals with disabilities; and

2. Members of the public with disabilities seeking information or services from a Federal agency to have access to and use of information and data https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines#E205-content https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines#E205-content that is comparable to the access and use of information and data by members of the public who are not individuals with disabilities.

b. Accordingly, any vendor submitting a proposal/quotations/bid in response to this solicitation must demonstrate compliance with the established EIT accessibility standards. Information about Section 508 visions is available at http://www.section508.gov/ The complete text of Section 508 Final Provisions can be accessed at https://www.access-board.gov/guidelines-and-standards. The Section 508 accessibility standards applicable to this solicitation are identified in the Statement of Work/Specification/Performance Work Statement. In order to facilitate the Government's evaluation to determine whether EIT products and services proposed meet applicable Section 508 accessibility standards, offerors must prepare an HHS Section 508 Product Assessment Template, in accordance with its completion instructions, and provide a binding statement of conformance. The purpose of the template is to assist HHS acquisition and program officials in determining that EIT products and services proposed support applicable Section 508 accessibility standards.

The template allows vendors or developers to self-evaluate their products or services and document in detail how they do or do not conform to a specific Section 508 standard. Instructions for preparing the HHS Section 508 Product valuation Template may be found on the HHS Web site (http://www.hhs.gov/web/508/contracting/technology/vendors.html).

d. Respondents to this solicitation must also provide any additional detailed information necessary for determining applicable Section 508 standards conformance, as well as for documenting EIT products or services that are incidental to the project, which would constitute an exception to Section 508 requirements. If a vendor claims its products or services, including EIT deliverables such as electronic documents and reports, meet applicable Section 508 accessibility standards in its completed HHS Section 508 Product Assessment Template, and it is later determined by the Government -- i.e., after award of a contract/order, that products or services delivered do not conform to the described accessibility standards in the Product Assessment Template, remediation of the products or services to the level of conformance specified in the vendor's Product Assessment Template will be the responsibility of the Contractor and at its expense.

Section 508 accessibility standards for HHS Web Site Content and Communications Materials

Regardless of format, all Web content or communications materials specifically produced for publication on, or delivery via, HHS Web sites, including text, audio, or video, under this contract shall conform to applicable Section 508 accessibility standards. Remediation of any materials that do not comply with the applicable accessibility standards of 36 CFR Part 1194 as set forth herein shall be the responsibility of the Contractor.

The following Section 508 accessibility standards apply to the content or communications material identified in this Statement of Work:

Telecommunications products;

Video and multimedia products and;

Web-based intranet and internet information and applications.

http://www.section508.gov/ https://www.access-board.gov/guidelines-and-standards http://www.hhs.gov/web/508/contracting/technology/vendors.html

FAR 52.204-24 - Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment

FAR 52.204-25 - Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

The laboratory at the University of Missouri Research Reactor has developed robust, analytical methods to measure trace elements in biological specimens. The Contractor’s laboratory methods have been shown to reliability measure blood concentrations of trace (i.e. Cu, Zn, Fe, Mg) and ultra-trace (i.e. Cd, Cr, Pb, As, Hg) elements in whole blood and red blood cells. The Contractor has developed high throughput inductively coupled plasma mass spectrometry (ICP-MS), direct mercury analysis (DMA) and instrumental neutron activation analysis (INAA) methods that require minimal sample volumes and provide accurate and precise measures of multiple elements to evaluate trace element epidemiology research hypotheses. The assays are very sensitive and gives quantitative results over a wide dynamic range. Currently, there is no other known Contractor available that can measure all of these trace and ultra-trace elements at the same time with the same reliability and precision and small volume. In addition, the Contractor laboratory provides guidance and consulting on trace element contamination, biospecimen collection and storage, the appropriate sample size, and by providing laboratory quality control metrics. Finally, the NCI has previously conducted a pilot study using the Contractor (HHSN261201200384P) and for comparability with the pilot study the NCI must use the same Contractor.

This is not a solicitation for competitive quotations. However, if any interested parties, especially small businesses, believe they can meet the above requirement, they may submit a statement of capabilities. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. A copy of the capability statement must be received in the NCI Office of Acquisition on or before 12:00 PM EST on September 6, 2019. All questions must be in writing and emailed to Kathy Elliott, Contract Specialist at Elliottk@mail.nih.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. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must have valid registration and certification on Sam.gov, www.sam.gov. No collect calls will be accepted. Please reference solicitation number 75N91019Q00114 on all correspondence.