FDA-SSN-1239924 Predictive Toxicology Technical Expert Services.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR

WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION

ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED

FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY

COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS

ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO

TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR

SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO

PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT,

IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION

REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND

NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) issues this Sources Sought announcement on behalf of the National Center for Toxicological Research (NCTR)’s Division of Bioinformatics and Biostatistics (DBB) in order to determine if there are existing small business sources capable of providing Predictive Toxicology Technical Expert services for a base year plus a possible four (4) one-year option years.

If your firm is considered a small business source under North American Industry Classification System (NAICS) 541690 – Other Scientific and Technical Consulting Services; with a Small Business Size Standard of $16.5 million, and you believe that your firm would be able to provide the FDA with the services described herein, please submit an email as instructed below. The vendor shall include information about the company and demonstrate that it can meet all of the minimum performance requirements listed herein.

Background The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Bioinformatics and Biostatistics (DBB) requires a Technical Expert in Predictive Toxicology; an experienced individual with written and oral presentation skills, and a thorough understanding of bioinformatics with specific knowledge in Predictive Toxicology. One of the essential roles of the DBB at the NCTR is to deal with the rapid growth of biomedical data present in the public domain and generated within the FDA and develop state-of-art bioinformatics and biostatistics methodologies to translate these burgeoning data to knowledge to be used in the FDA.

One area of this research is Predictive Toxicology. Specifically, the goal is to collect and analyze all clinical and preclinical parameters of each drug that has been reported to cause unwanted side effects, and to generate gene-expression data from in vitro studies and other studies to identify potential biomarkers. This will aid in the efforts to determine drug safety and in the extension of understanding precisely which patients will most likely benefit from a given drug or dose, and which patients would be most likely to suffer unwanted effects from that same drug or dose.

Objective It is critical for the Division of Bioinformatics and Biostatics to develop and coordinate informatics capabilities within NCTR, across FDA Centers, and in the larger toxicological community. It is important for these capabilities to be communicated in an effective manner with the research community and the FDA. This requires an experienced individual with written and oral presentation skills, a thorough understanding of bioinformatics with respect to drug development and safety evaluation, and extensive experience in the field of Predictive Toxicology.

Scope of Work FDA seeks a contractor with demonstrated expertise in working with Predictive Toxicology. The contractor will support the FDA/Division of Bioinformatics and Biostatics to develop and coordinate informatics capabilities within NCTR and FDA Centers. The contractor shall have a thorough understanding of bioinformatics with specific knowledge in Predictive Toxicology with bioinformatic tools. The contractor shall work in close coordination with the DBB at NCTR in Jefferson, Arkansas, and shall assist in the formulation of innovative ideas/approaches to address the current needs in Predictive Toxicology development, to advise bioinformatics staff in the appropriate methods of writing papers and protocols, and to provide support in the generation of manuscripts and other documentation. This shall require periodic visits to the NCTR Campus and communication with the DBB staff via other electronic means, including video conferencing. Specifically, the contractor shall communicate via e-mail, phone calls and video conferences to make recommendations as appropriate, and to schedule visits to the NCTR campus, with the Technical Point of Contact (TPOC).

Minimum Performance Requirements

1. The contractor shall conduct Manuscript Review/Protocol Development at the contractor’s facility and shall not exceed 208 hours per year (approximately four hours per week). The contractor shall review draft manuscripts related to Predictive Toxicology; provide recommendations for revisions to manuscript to prepare for publication following the standard practices in the scientific community for conducting manuscript writing; and assist in the development of research protocols to further the research.

The Director of DBB shall have the ultimate decision on all revisions to manuscripts and protocols before final submission to NCTR for approval.

2. The contractor shall visit NCTR one time per year with each visit being for a period of at least 5 business days. The purpose of the visit is to train DBB Junior scientists and to assist the DBB in the writing of manuscripts and research protocols related to Predictive Toxicology. Visits shall include seminars and/or training sessions for groups and individuals within DBB to communicate the latest developments in the field of Predictive Toxicology. The contractor shall perform needed literature assessment, etc., therefore, shall furnish equipment needed to access these resources (i.e.

personal laptop). NCTR shall provide access to guest Wi-Fi and projection equipment if needed for presentations.

If unable to visit NCTR due to travel restrictions related to the COVID-19 pandemic contractor shall perform above requirements via virtual platform (video conference).

NOTE: The contractor shall review, one at a minimum but no more than four, manuscripts and/or protocols during the performance period of the contract.

3. Contractor shall participate in one or two video and/or teleconference meetings per month (meetings approximately 1 hour each).

Minimum Position Requirements and Qualifications

1. Shall have in-depth knowledge of current issues in the field of Predictive Toxicology

2. Shall have presented at one or more international conferences on the subject of Predictive

Toxicology, and held a substantive office (e.g., President) in a major toxicological society

3. Shall have extensive experience in instructing research professionals

4. Shall have extensive experience in technical writing and editing

5. Shall have experience in supervising graduate students and postdoctoral fellows

6. Shall have verifiable records of publications in cited scientific journals and publications

7. Shall have experience within the pharmaceutical industry, specifically related to drug safety and drug development.

8. Shall have Ph.D. and at least 10 years’ experience in the field of Predictive Toxicology

Deliverables and Milestones Deliverables Task Due Date Manuscript Review/ Protocol Development

Review draft manuscripts related to Predictive Toxicology to provide recommendations for revisions to prepare manuscript for publication following the standard practice in the scientific community for conducting manuscript writing and assist in the development of research protocols to further the research. (The Director of DBB shall have the ultimate decision on all revisions to manuscripts and protocols before final submission to NCTR for approval.)

Annually

Visit NCTR one time per year (at least 5 business days)

Visit shall include seminars and/or training sessions for groups and individuals within DBB to communicate the latest developments in the field of Predictive Toxicology. Assist the DBB in the writing of manuscripts and research protocols related to Predictive Toxicology.

Annually

Attend meetings Participate in video and/or teleconference meetings Once or twice per month (approximately 1 hour each)

Reports Provide invoice with a summary of work completed Quarterly

Period(s) of Performance. Anticipated to be a Base plus four (4) Option Years with projected period of performance dates estimated as:

Base Year: 08/13/2021 – 08/12/2022 Option Year 1: 08/13/2022 – 08/12/2023 Option Year 2: 08/13/2023 – 08/12/2024 Option Year 3: 08/13/2024 – 08/12/2025 Option Year 4: 08/13/2025 – 08/12/2026

Place of Performance Work shall be performed at the at the contractor’s place of business. However, the contractor shall be required to travel to NCTR to meet with junior staff and the Project Officer to review materials and conduct training at:

US FDA National Center for Toxicological Research (NCTR) 3900 NCTR Rd.

Jefferson AR 72079

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in providing expert services in Predictive Toxicology. Though the target audience is small business vendors or small businesses capable of supplying a U.S. product/service of a small business vendor or producer, all interested parties may respond. At a minimum, responses shall include the following:

• Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm.

• Past Performance information shall include recent (within the last 3 years) and relevant (prior experience) information for services of the same or substantially similar to Predictive Toxicology Technical Expert services. For each past performance reference include the date of service, description of service provided, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact (POC) phone number, client POC email address, and name of company (to include DUNS number and size status) if not the respondent..

• The offeror shall furnish capability statements with sufficient technical information necessary for the Government to conclusively determine that the offered products/services meet the technical requirements identified above. Respondents shall limit their capability statements to no more than ten (10) pages, excluding cover page and table of contents.

• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested.

• If a large business, provide if subcontracting opportunities exist for small business concerns.

• Though this is not a request for quote, informational pricing is encouraged.

The Government is not responsible for locating or securing any information not identified in the response.

Interested Contractors must respond with capability statements which are to be submitted by email only to the point of contact listed below on or before 2:00 pm (Central Time in Jefferson AR) on March 31, 2021 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference: FDA-

SSN-1239924.

Notice of Intent Responses to this source sought announcement will assist the Government in determining whether any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures

Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

After a review of the responses received, a pre‐solicitation synopsis or combined synopsis/ solicitation may be published in beta.SAM.gov – Contracting Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality and Proprietary Information No proprietary, classified, confidential, or sensitive information should be included in your response.

The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).

mailto:suzanne.martella@fda.hhs.gov