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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) has issued this sources sought announcement on behalf of the National Center for Toxicological Research (NCTR) in order to determine if there are existing small business sources capable of providing services for an experienced individual in the bioinformatics research of organ toxicity with specific focus on liver, kidney and heart.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 541690 - Other Scientific and Technical Consulting, Small Size Standard $19.0 Million, and believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Warren.Dutter@fda.hhs.gov. The vendor should include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Background:

The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Bioinformatics and Biostatistics (DBB) requires input of an experienced individual in the bioinformatics research of organ toxicity with specific focus on liver, kidney and heart. One of the essential roles of the DBB 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 this burgeoning data to practical knowledge available to FDA researchers. One area is to determine the safety margin of market drugs that cause organ toxicity by integrating the diverse data sets from the public domain including, but not limited to, both preclinical and clinical findings, and new data stream from emerging technologies such as omics and HTS (high throughput screening), imaging data, etc.

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 toxicology 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 both writing and oral presentation skills, a thorough understanding of bioinformatics research on organ toxicity with specific focus on liver, kidney and heart

Scope of Work:

Working in close coordination with the DBB at NCTR in Jefferson, Arkansas, the contractor shall assist in the formulation of innovative ideas/approaches to address the current needs in study of organ toxicity with specific focus on liver, kidney and heart with bioinformatics, advise young staff in the appropriate methods of writing scientific manuscripts and research protocols, and provide support in the generation of manuscripts for submission to scientific journals.

This will require one site visit to the NCTR Campus as well as communication with the DBB staff via e-mail, phone and videoconferencing (i.e. Microsoft Teams or Zoom) to collaborate and make recommendations as appropriate, and to schedule required site visit at the NCTR campus.

Minimum performance requirements: (not to exceed 250 hours)

Contactor’s Faciltiy/Virtual:

The contractor shall assist in the formulation of innovative ideas/approaches to address the current needs related to bioinformatics studies on organ toxicity with specific focus on liver, kidney and heart; and shall advise bioinformatics staff in the appropriate methods of writing scientific manuscripts and research protocols and provide support in the generation of manuscripts for submission to scientific journals. This shall require communication with the DBB staff via e-mail, phone and videoconferencing (i.e. Microsoft Teams or Zoom) by performing the following:

• The contractor shall attend videoconference meetings (i.e. Microsoft Teams or Zoom) no more than 4 times per month. (approximately 1 hour each).


• The contractor shall advise young staff in the appropriate methods of writing scientific manuscripts and research protocols following the standard practices used in the scientific community.


• The contractor shall assist in the development of research protocols and review draft research protocols and provide recommendations for revisions to further the research.


• The contractor shall review draft manuscripts and provide recommendations for revisions to prepare for publication to scientific journals following the standard practice used in the scientific community for writing a scientific manuscript.

The Director of DBB will have the ultimate decision on all revisions to manuscripts and protocols (including the authorship) before final submission to NCTR for approval.

FDA Facility (NCTR):

The contractor shall visit NCTR one time during the performance period for a period of 1 week (5 business days). The purpose of the visit is to assist the DBB in the writing of manuscripts and research protocols and provide guidance for on-going bioinformatics projects related to organ toxicity with specific focus on liver, kidney and heart. The site visit shall include seminars and/or training sessions for groups and individuals within DBB to communicate the latest developments in the field of bioinformatics-driven organ toxicity with specific focus on liver, kidney and heart research. As needed the contractor shall perform literature assessments and access resources for presentations, etc., therefore, shall furnish equipment needed to access these resources (i.e. personal laptop). NCTR will provide access to guest Wi-Fi and projection equipment if needed.

If in person site visits not permissible due to ongoing COVID-19 pandemic contractor shall perform site visit requirements virtually.

Minimum Position Requirements & Qualifications:

Education and experience:

1. Shall provide the proposed Candidate(s) Resume / Curriculum Vitae,


2. Shall demonstrate in-depth knowledge (at least 10 years) of current issues in the field of organ toxicity with specific focus on liver, kidney and heart.


3. Shall have presented at one or more international conferences on the subject of organ toxicity.


4. Shall have extensive experience in instructing research professionals.


5. Shall have extensive experience in technical writing and editing


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


7. Shall have at least 5 verifiable records of publications in cited scientific journals and publications related to organ toxicity as primary author.


8. Shall have PhD, or minimum 15-20 years’ proven research experience in the field of organ toxicity.

Deliverables and Milestones:

Deliverables

Task

Due Date

Manuscript Review/Protocol Development

Assist in the formulation of innovative ideas/approaches to address the current needs related to bioinformatics studies on organ toxicity with specific focus on liver, kidney and heart; and advise bioinformatics staff in the appropriate methods of writing scientific manuscripts and research protocols and provide support in the generation of manuscripts for submission to scientific journals. Communicate with the DBB staff via e-mail, phone and videoconferencing (i.e. Microsoft Teams or Zoom) by performing the following:

(1) Advise young staff in the appropriate methods of writing scientific manuscripts and research protocols following the standard practices used in the scientific community.

(2)Assist in the development of research protocols and review draft research protocols and provide recommendations for revisions to further the research.

(3) Review draft manuscripts and provide recommendations for revisions to prepare for publication to scientific journals following the standard practice used in the scientific community for writing a scientific manuscript

(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)

Assist in the writing of manuscripts and research protocols and provide guidance for on-going bioinformatics projects related to organ toxicity with specific focus on liver, kidney and heart. The site visit shall include seminars and/or training sessions for groups and individuals within DBB to communicate the latest developments in the field of bioinformatics-driven organ toxicity with specific focus on liver, kidney and heart research. Perform literature assessments as needed.

*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).

Annually

Attend meetings

Participate in video and/or teleconference meetings

Up to 4 times per month (approximately 1 hour each)

Summary Reports

Report shall contain a detailed summary of work performed for/during site visits, protocol/manuscripts reviewed, meetings attended, seminars/trainings provided, and any other notable activities during the billing period. Report shall include hours expended during the reporting period and the cumulative amount for the period of performance.

At time of invoicing

Period of Performance:

Base Period: 2023-2024*

Option Period 1: 2024 – 2025*

Option Period 2: 2025 – 2026*

Option Period 3: 2026 – 2027*

Option Period 1: 2027 – 2028*

*Period of performance for the base and option periods in any resultant award will be based on the date of award.

Place of Performance:

Some research work may be performed at the contractor’s place of business. However, the contractor will be required to travel to NCTR to meet with junior staff and the Project Officer to review materials and conduct training. As needed the contractor shall perform literature assessments and access resources for presentations, etc., therefore, shall furnish equipment needed to access these resources (i.e. personal laptop). NCTR will provide access to guest Wi-Fi and projection equipment if needed.

Address:

FDA/NCTR

3900 NCTR Rd.

Jefferson, AR. 72079

Though the target audience is small business vendors or small businesses capable of supplying a U.S. 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, Unique Entity ID (SAM) 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.


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


• 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 bioinformatics research of organ toxicity with specific focus on liver, kidney and heart 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 phone number, client point of contact email address, and name of company (to include DUNS number and size status) if not the respondent.


• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered services meet the technical requirements identified above.


• 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 applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.


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


• Though this is not a request for quote, informational pricing for the service would be helpful for market research purposes.

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 due by email to the point of contact listed below on or before February 6, 2023 by 1:00 PM Central Time at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Warren Dutter, email warren.dutter@fda.hhs.gov. Reference: 75F40123SSN116637.

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 and solicitation may be published in sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality

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).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.

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