Special_Notice_Gryphon_FBO,_75N91019Q00104.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: 75N91019Q00104

Proposed Posted Date: August 19, 2019

Proposed Response Date: August 26, 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.

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.

The anticipated period of performance shall be two (2) months from date of award.

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

BACKGROUND

The National Cancer Institute (NCI), Center for Cancer Research (CCR), Radiation Oncology Branch (ROB), Experimental Therapeutics Section (ETS) exists to plan and conduct pre-clinical and clinical research on the biologic and therapeutic effects of radiation administrated alone or in combination with other modalities of treatment; to develop novel technology and imaging based approaches for radiation oncology; to investigate the natural history of disease to understand and evaluate means of diagnostic assessment for the purpose of optimizing treatment selections; and to provide radiation therapy as well as general oncology consultations for patients admitted to other NIH Clinical Research Center (CRC) clinical services, in a collaborative approach.

Scope

The Contractor shall perform data cleaning and notify the NCI Technical Point of Contact (TPC) of the results of the data cleaning (how many data points were found to be significant, representing how many biomarkers of survival, organ-specific injury, and dose/time-specific markers). These data will be delivered to the NCI Radiation Oncology Lab. The Contractor shall also deliver the R code for analyzing the data to the NCI. After the data cleaning, the Contractor shall develop several classifier models using “R” and, once these models are verified, the Contractor shall deliver the models to the NCI Radiation Oncology Lab. Each of these models will be populated with the significant data and various appropriate classifier models and related analysis will be delivered to the NCI Radiation Oncology Lab. The data will be presented in a laboratory meeting with the NCI laboratory. These data will be delivered in a spreadsheet to the

NCI TPC.

The Contractor shall identify biodosimetry biomarkers in this study that shall be reasonably accurate and rapidly available for dose and survival assessment that shall allow medical responders to triage individuals who are minimally exposed and do not need treatment immediately compared to those who received high dose radiation. These could then be developed as part of the Point of Care and High Throughput screening platforms that are under development by other groups as part of National Institute of Allergy and Infectious Diseases (NIAID) and Biomedical Advanced Research and Development Authority (BARDA) programs.

Contractor Requirements

The Contractor must be an independent company and is engaged in its own business. It is qualified to perform the work under this agreement, and all information provided to the client is accurate with respect to its qualifications, experience, affiliations, and financial records. The Contractor shall provide the NCI with data normalization and filtering, in addition to sophisticated data analysis services, including classifier development.

The Contractor shall perform the following tasks:

4.1 Identify biomarker signatures that indicate survival from radiation challenge;

4.2 Examine differential expression of mRNA biomarkers across organs in irradiated mice;

4.3 Examine differential expression of miRNA biomarkers across organs in irradiated mice;

4.4 Present the data to the NCI laboratory.

PLACE OF PERFORMANCE

The services shall be performed at the Contractor’s facility and at the NCI at the following address:

National Cancer Institute (NCI) Radiation Oncology Branch (ROB) 10 Center Drive Building 10, Room B3B405 Bethesda, MD 20892

Report(s)/Deliverables and Delivery Schedule

Deliverable Deliverable Description / Format Requirements Due Date

#1 (Tasks 4.1) Identify biomarker signatures that indicate survival from radiation challenge.

2 months after award

#2 (Tasks 4.2) Examine differential expression of mRNA biomarkers across organs in irradiated mice.

2 months after award

#3 (Tasks 4.3) Examine differential expression of miRNA biomarkers across organs in irradiated mice.

2 months after award

#4 (Tasks 4.4) Present the data to the NCI. 2 months after award

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 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 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 http://www.section508.gov/ https://www.access-board.gov/guidelines-and-standards 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.

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.

http://www.hhs.gov/web/508/contracting/technology/vendors.html

Gryphon Scientific is a specialized, small business consulting practice comprised of life scientists and health researchers who apply rigorous scientific analysis to problems of global health and homeland security. The core strength of Gryphon Scientific is the needed expertise and experience in management and handling of large multiple data sets. The senior technical specialist at Gryphon has a Master of Science in statistics, with years of experience in analyzing biomedical data sets that are more complex than the dataset in this project. Moreover, this technical specialist has experience programming in the open source platform “R” to clean data and develop classifier models. The principal technical specialist at Gryphon has years of experience in working with microarray data sets for cancer research, and also has programming experience. The health physicist at Gryphon has a master’s in health physics, programming experience and has experience in drafting response plans related to the response to nuclear attacks. The director and senior scientist at Gryphon have more than a decade experience working on modeling the effects of nuclear weapons; and in fact, developed the computational model that supported new triage algorithms for radiation injuries arising from nuclear attacks.

Moreover, this director was one of the first researchers to use a microarray to characterize the cellular response to stress (in the late 1990s).

Gryphon Scientific is the only known supplier with all of the needed areas of expertise and experience. The Contractor previously analyzed the NCI’s RNA biomarker expression data from mouse and minipig whole blood after whole-body irradiation (Contract # HHSN261201800265P). In order to compare the new data in this contract to the NCI’s previous data, it must be analyzed by the same Contractor so that the data is compatible.

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 10:00 AM EST on August 26, 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 75N91019Q00104 on all correspondence.