75N91021Q00070_SB SourcesSought.pdf

Title: Professional Scientific and Medical Guidance on NCI/CTEP Extramural Clinical Trials, Network Programs, and Treatment Trials

Document Type: Small Business Sources Sought

Reference Number: 75N91021Q00070

Posted Date: 04/21/2021

Response Date: 04/27/2021

Classification Code: R499 – Support – Professional: Other

NAICS Code: 541715 – Research and Development in the Physical, Engineering, and

Life Sciences (except Nanotechnology and Biotechnology) 541990 – All Other Professional, Scientific, and Technical Services.

Contracting Office Address:

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E136, Rockville, MD

20892, UNITED STATES.

Description:

This is a Small Business Sources Sought Notice for an oncologist to work as a Subject Matter Expert (SME) Contractor. This notice is for information and planning purposes only. This is NOT a solicitation for proposals or quotations and shall not be construed as an obligation on the part of the Government.

The purpose of this Sources Sought Notice is to identify qualified small business concerns, including 8(a), HUBZone or Service-Disabled Veteran-owned business concerns, that are interested in and capable of performing the work described herein. Responses to this notice will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice.

This notice is strictly for market research and information purposes only. The responses to this notice shall be used to assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned North American Industry Classification System (NAICS) code 541990 – All Other Professional, Scientific, and Technical Services and the business size standard is $16.5 million.

As a result of this Sources Sought Notice, the Government may issue a Request for Quotation (RFQ) through beta.SAM.gov. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this Sources Sought Notice or the Government’s use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement.

The purpose of this requirement is to purchase commercially available services from an oncologist to work as a Subject Matter Expert (SME) consultant providing professional, scientific, and medical guidance that shall be used by the Cancer Therapy Evaluation Program (CTEP) within the Division of Cancer Treatment and Diagnosis (DCTD) at the National Institutes of Health (NIH) National Cancer Institute (NCI).

1. BACKGROUND

The National Cancer Institute (NCI) is an Institute within the National Institutes of Health (NIH), whose mission is to plan, conduct, and coordinate the National Cancer Program and involves, (a) research on the causes, detections, diagnosis, preventions, treatment, and palliative care of cancers and on rehabilitation of the cancer patient and (b) demonstration of the effectiveness of cancer control methods and techniques.

The NCI Division of Cancer Treatment and Diagnosis (DCTD) takes prospective detection and treatment leads, facilitates their paths to clinical application, and expedites the initial and subsequent large-scale testing of new agents, biomarkers, imaging tests, and other therapeutic interventions (radiation, surgery, immunotherapy) in patients.

As such, the DCTD funds and conducts large scale studies on precision medicine that involve evaluation of pre-clinical studies and clinical research methods to predict response to systemic cancer treatment as well as treatment trials under collaborative agreements with pharmaceutical and biotechnology companies. DCTD supports extramural clinical trial network programs through the Cancer Therapy Evaluation Program (CTEP). CTEP’s two largest clinical trials network programs involve the NCI Experimental Therapeutics Clinical Trials Network (ETCTN) focused on early phase 1 and phase 2 trials (overseen by CTEP’s Investigational Drug Branch) and the NCI National Clinical Trials Network (NCTN) focused on phase 2 and phase 3 late phase clinical trials (overseen by CTEP’s Clinical Investigations Branch). These two clinical trials programs enroll between 20,000 and 25,000 patients annually at over 2,000 participating sites. Approximately 70% of the clinical trials supported under these network programs are conducted with NCI DCTD/CTEP as the legal Investigational New Drug (IND) sponsor of the trials. All of the trials supported by CTEP include collaborations with a wide variety of centers and institutions worldwide. In addition, CTEP IND trials often include two or more pharmaceutical companies, diagnostic companies and other participants, requiring extensive and complex negotiations on the design and management needed to support and conduct these federally funded clinical trials to address the needs of all partners.

Oncology drug development has traditionally focused on toxicity, dosing, and schedule of therapy, but with the advent of personalized medicine, it must now also encompass qualification of biomarkers to select patients, define toxicity, and monitor outcomes. These growing demands require effective integration of the CTEP with other key DCTD programs, including the Cancer Diagnosis Program (CDP), the Radiation Research Program (RRP), the Cancer Imaging Program (CIP), the Developmental Therapeutics Program (DTP), and the Biometrics Research Program

(BRP).

NCI DCTC/CTEP supports cancer treatment trials across the spectrum of both hematologic and solid tumor malignancies, include both IND and non-IND trials. NCI DCTD/CTEP is also in the process of developing several new Precision Medicine Initiatives that will encompass biomarker-driven, precision medicine and immunotherapy trials in oncology testing combinations of targeted drugs supported by preclinical in vivo evidence (NCI ComboMATCH), targeted combinations in acute myeloid leukemia (MYELOMATCH), and new immunotherapy approaches in, a variety of cancer types (iMATCH). These initiatives all require expertise in the design and conduct of a new type of clinical trial (involving both umbrella and basket designs) that specifically address the unique characteristics of these initiatives. Physician oncologic consulting expertise is needed to support development, implementation, and monitoring both selected NCI/CTEP treatment trials in hematologic and solid tumors as well as the new Precision Medicine Initiatives (PMIs) described above and existing NCI DCTD/CTEP PMIs, including Adult MATCH trial, the DART trial, and the ALCHEMIST project in early-stage lung cancer.

In performance of these clinical trials, the NCI is in need of a senior physician consultant to work as a Subject Matter Expert (SME) with NCI/CTEP within DCTD to provide guidance that shall be used by NCI leadership to inform their decision-making process. The consulting SME shall provide guidance on the background justification for the scientific objectives and medical safety of the trials supported by CTEP, the interaction between the regulatory aspects of clinical trial agreements and terms for trials with pharmaceutical collaborators and extramural investigators, and comment on the content and provide feedback on specific concerns by the extramural investigators as well as the extramural sites subject to the medical/scientific and policy requirements of the specific CTEP-supported clinical trials that they participate in. In addition, this physician consultant shall offer guidance on other DCTD initiatives that affect its clinical trials network programs as requested by NCI leadership. The physician consultant shall also provide guidance on the clinical trials being supported by CTEP, especially biomarker-driven, precision medicine trials in both tissue agnostic and disease-specific indications as requested by the CTEP Associate Director, the Developmental Therapeutics Program (DTP) Associate Director, the Cancer Diagnosis Program (CDP) Associate Director, and the DCTD Director in support of their decision-making process.

2. SCOPE

DCTD requires services from one (1) Subject Matter Expert (SME) for professional scientific and medical guidance on CTEP extramural clinical trials, network programs, and treatment trials.

NCI-sponsored clinical trials contain many complex components. The SME shall provide in-depth expert evaluation and review of the interactions between various NCI programs, the extramural clinical investigators conducting the trials, the NCI contractors supporting the clinical development program, and pharmaceutical collaborator providing agents or diagnostic tests for CTEP Investigational New Drug (IND) or Investigational Device Exemption (IDE) trials. The contractor shall work with the relevant DCTD/CTEP project managers and NCI DCTD/CTEP staff in the Clinical Investigations Branch and the Investigational Drug Branch as well as with the NCI NCTN Groups and the NCI ETCTN organizations to accomplish this goal. All work by the Contractor shall be for informational purposes only to be used by NCI leadership to inform their decision-making process.

It is anticipated currently that the Contractor shall provide input/advice on the development of 4 new trial/study proposals on average per month (2 select heme/solid tumor trials, 1 PMI sub-study trial, and 1 correlative ancillary study). In addition, the contractor shall monitor accrual and conduct issues requiring amendments related to approximately 25 active trials per year.

Evaluation of new study proposals and monitoring of active studies are performed through regular meetings as outlined in the Contract Requirements. It is estimated that the contractor shall attend the following regular meetings for the entire period and that preparatory time and follow-time will be equivalent to the call/meeting time (i.e., 1 call of 2 hours would require an additional 2 hours in associated preparatory time and 2 hours in follow-up time for a total of 6 hours):

• Disease-Specific Steering Committee Calls: 1 call of 2 hours in length each month

• Disease-Specific Task Force Calls: 4 calls of 1 hour in length each month

• CTEP Protocol Review Committee Call: 4 calls of 3 hours in length each month

• CTEP Concept/Correlative/Accrual Call: 4 calls of 1 hour in length each month

It is anticipated that an additional 8 to 10 hours per week would be needed to provide additional guidance on the selected trials and PMI trials. The scientific and medical input/advice provided by the contractor shall allow DCTD to complete Consensus Evaluations for extramural investigators; address questions/concerns raised by the FDA on IND or IDE issues; and develop amendments and modifications for active trials and PMI sub-studies.

3. CONTRACT REQUIREMENTS AND PERSONNEL QUALIFICATIONS

In support of DCTD/CTEP staff, the Subject Matter Expert shall:

3.1 Report status of work on a monthly basis, detailing activities with allocation of labor hours and identification of work products for the period. A final report shall be provided at the end of the Period of Performance summarizing all work completed.

3.2 Complete work products/documents related to compiling pertinent data, including assessment of the supporting pre-clinical and clinical data, patient safety issues, agent side effects, appropriate patient monitoring, and other aspects of patient care, to ensure DCTD/CTEP staff can complete final Consensus Evaluations for extramural investigators.

3.3 Complete work products and documents related to compiling pertinent data in order to provide written scientific input and advice on select hematologic and solid tumor malignancies and PMI sub-studies to address questions/concerns raised by the FDA on IND or IDE issues.

3.4 Complete work products and documents related to compiling pertinent data to provide written scientific input and advice on amendments for active select hematologic and solid tumor malignancy trials and PMI sub-studies so DCTD/CTEP can make final decisions on the need for amendments and any required modifications to the amendments before final approval is provided by NCI.

3.5 Provide scientific and medical guidance to extramural DCTD/CTEP staff on selected hematologic and solid tumor malignancy clinical treatment trials and PMI trials being proposed and developed for conduct in the NCI National Clinical Trials Network (NCTN) and the NCI Experimental Therapeutics Clinical Trials Network (ETCTN), including sharing expert interpretation of various viewpoints from the extramural research community on the trials to help aid in DCTD/CTEP staff and senior DCTD leadership decision-making.

3.6 Review clinical treatment trials, including Clinical Trials collaborations with pharmaceutical partners for trials involving cooperative research and development agreements (CRADAs) for which NCI/DCTD is the legal IND sponsor, in concordance with general CTEP policies and with policies specific for trials involving CTEP IND agents.

3.7 Participate in appropriate meetings, in person or via phone/webinar and provide scientific and medical guidance related to selected hematologic and solid tumor trials and PMI trials. These meetings include, but are not limited to:

• Disease-Specific Steering Committee Calls

• Disease-Specific Task Force Calls

• CTEP Protocol Review Committee Call

• CTEP Concept/Correlative/Accrual Call

3.8 Edit appropriate review assessments for both tissue agnostic and disease-specific trials, especially trials involving gastrointestinal malignancies. DCTD shall make all final decisions regarding assessments generated by the SME.

3.9 Provide scientific and medical guidance to pharmaceutical collaborators regarding appropriate scientific and medical rationale for language in the clinical agreements on selected hematologic and solid tumor malignancy treatment trials and PMI trials

3.10 Review administrative policies and procedures supporting NCI DCTD/CTEP PMIs and provide scientific and medical guidance to DCTD/CTEP to assist in their decision-making process.

3.11 Provide scientific and medical insight related to the development of novel collaborations and treatment approaches for PMI trials as well as on other selected hematologic and solid tumor treatment trials with extramural investigators and pharmaceutical partners

3.12 Provide professional scientific and medical opinion on future initiatives associated with special projects and precision medicine trials planning, as directed by DCTD. DCTD Leadership shall have final decision-making authority on all future initiatives.

3.13 Contractor personnel shall possess an active US License to practice medicine and board-certification in Medical Oncology

3.14 Contractor personnel shall demonstrate extensive experience (minimum 10 years) in FDA regulatory requirements related to conduct of clinical treatment trials in oncology

3.15 Contractor personnel shall demonstrate extensive experience (minimum 10 years) in clinical trial design and conduct, especially with respect to multi-center, biomarker-driven, precision medicine oncology treatment trials

3.16 Contractor personnel shall have strong, written communication skills

3.17 Contractor personnel shall have excellent analytical, and time management skills

3.18 Contractor personnel shall demonstrate Senior-Level/Managerial leadership experience in academia, such as Chair of an academic or clinical department, or senior level position in the government.

3.19 Contractor personnel shall demonstrate past participation in scientific advisory boards or committees, at least two (2).

4. PERIOD OF PERFORMANCE

The period of performance shall consist of one (1) 12-month base period, plus two (2) 12-month option periods.

5. PLACE OF PERFORMANCE

National Cancer Institute 9000 Rockville Pike Bethesda, MD 20892

This work may also be performed remotely.

6. REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

Pursuant to FAR clause 52.212-4, all work described in the SOW to be delivered under this purchase order is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the Contracting Officer’s Representative (COR), who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

Regardless of format, all digital content or communications materials produced as a deliverable under this contract, shall conform to applicable Section 508 Standards to allow Federal employees and members of the public with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by Federal employees or by members of the public who are not individuals with disabilities. Remediation of any materials that do not comply with the applicable Section 508 requirements as set forth below, shall be the responsibility of the Contractor.

HHS guidance regarding accessibility of documents can be found at https://www.hhs.gov/web/section-508/making-files-accessible/create-accessible-pdfs/index.html.

Federal government-wide guidance regarding accessibility of documents can be found at https://www.section508.gov/, including the documents describing the preferred method of authoring and testing documents produced in Microsoft Word 2013 or later, Microsoft Excel, and files formatted as PDF.

All written deliverable products shall be submitted in draft format for review, comment and approval by the COR. Final copies of approved drafts shall be delivered to the COR within five

(5) business days after receipt of the Government’s comments.

All written draft and final deliverable products shall be submitted in electronic copy for review and comment. If requested, final deliverable products shall be submitted in an electronic format.

Other quantities and formats may be submitted after prior approval from the COR.

All deliverables shall be sent electronically (Microsoft Word, PDF, or Excel 2013, unless approved by the COR) per the following deliverable schedule:

Reporting Requirements and Deliverables:

The contractor shall deliver the following items within the applicable Period of Performance/ stated deadlines in the order and as coordinated with the NCI Contracting Officer’s Representative (COR). A monthly report shall be submitted to the COR and CO, via an appropriate government email address to be provided to the contractor, detailing activities with allocation of labor hours and identification of work products for the period. The NCI COR shall review and accept the monthly reports. Any deficiencies identified shall be corrected prior to the final approval, and before the end of the Period of Performance. If no comments or requests for revisions from the NCI COR are provided to the contractor within 30 days of receipt of deliverables, the deliverables will be considered acceptable. If comments or requests for revisions from the NCI COR are provided to the contractor, the contractor will have 30 days to respond to comments an and/or provide revisions.

https://www.hhs.gov/web/section-508/making-files-accessible/create-accessible-pdfs/index.html https://www.hhs.gov/web/section-508/making-files-accessible/create-accessible-pdfs/index.html https://www.section508.gov/

DELIVERABLE/TASK DELIVERABLE DESCRIPTION DUE DATE

BASE PERIOD

Base Period – Monthly Reports (Task 3.1)

Monthly Report detailing activities with allocation of labor hours and identification of work products for the period

All activities specifically related to Tasks 3.5, 3.6, 3.7, 3.8, 3.9, 3.10, & 3.11 shall be addressed in the Monthly Report.

The Monthly Report shall be an electronic document. Acceptable formats include Microsoft Word, Excel, or PowerPoint; or Adobe PDF.

5 business days After Receipt of Order (ARO) to

COR

Base Period – Consensus Evaluation Support (Task 3.2)

Work products/documents related to compiling pertinent data (including assessment of the supporting pre-clinical and clinical data, patient safety issues, agent side effects, appropriate patient monitoring, and other aspects of patient care) in order to provide written scientific input and advice on selected trial proposals and/or associated correlative ancillary studies. The trial proposals (and/or associated correlative ancillary studies) will be for select hematologic and solid tumor malignancies and PMI sub-studies. Scientific input and advice on the trial proposals shall be provided to DCTD/CTEP staff per established timelines for the NCTN and ETCTN programs to ensure DCTD/CTEP staff can determine the final decision for a proposal and submit that decision and an associated Consensus Evaluation to the appropriate extramural investigators in a timely manner.

4-weeks after initial request from

COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Base Period – FDA Question Support (Task 3.3)

Work products and documents related to compiling pertinent data in order to provide written scientific input and advice on select hematologic and solid tumor malignancies and PMI sub-studies to DCTD/CTEP staff with respect to questions/concerns raised by the FDA on IND or IDE issues. Scientific input and advice on these FDA issues shall be provided to DCTD/CTEP staff per established

4-weeks after initial request from

COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt timelines to ensure DCTD/CTEP staff can determine a final decision on how to respond to the FDA by established regulatory timelines.

from COR

Final versions due 5-business days after COR approval of finalized draft

Base Period – Amendment Support (Task 3.4)

Work products and documents related to compiling pertinent data to provide written scientific input and advice to DCTD/CTEP staff on amendments for active select hematologic and solid tumor malignancy trials and PMI sub-studies so DCTD/CTEP can make final decisions on the need for amendments and any required modifications to the amendments before final approval is provided by NCI.

4-weeks after initial request from

COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Base Period – Commentary on New Initiatives and Special Projects (Task 3.12)

As a Subject Matter Expert, the contractor shall provide advice and guidance to CTEP leadership to support their decision making around new initiatives and special projects.

4-weeks after initial request from

COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Base Period – Final Report (Task 3.1)

Report Summarizing activities conducted during the period.

The Final Report shall be an electronic document. Acceptable formats include

4-weeks prior to end of Period of Performance.

Subsequent comments on the draft must be addressed within 1-week of receipt from COR

Final versions due

5-business days after COR approval of finalized draft

OPTION PERIOD 1

Option Period 1 - Monthly Reports (Task 3.1)

Monthly Report detailing activities with allocation of labor hours and identification of work products for the period

All activities specifically related to Tasks 3.5, 3.6, 3.7, 3.8, 3.9, 3.10, & 3.11 shall be addressed in the Monthly Report.

The Monthly Report shall be an electronic document. Acceptable formats include

Option Period 1 -

Support (Task 3.2)

Work products/documents related to compiling pertinent data (including assessment of the supporting pre-clinical and clinical data, patient safety issues, agent side effects, appropriate patient monitoring, and other aspects of patient care) in order to provide written scientific input and advice on selected trial proposals and/or associated correlative ancillary studies. The trial proposals (and/or associated correlative ancillary studies) will be for select hematologic and solid tumor malignancies and PMI sub-studies. Scientific input and advice on the trial proposals shall be provided to DCTD/CTEP staff per established timelines for the NCTN and ETCTN programs to ensure DCTD/CTEP staff can determine the final decision for a proposal and submit that decision and an associated Consensus Evaluation to the appropriate extramural investigators in a timely manner.

4-weeks after initial request from

COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Option Period 1 - FDA Question Support (Task 3.3)

Work products and documents related to compiling pertinent data in order to provide written scientific input and advice on select hematologic and solid tumor malignancies and PMI sub-studies to DCTD/CTEP staff with respect to questions/concerns raised by

4-weeks after initial request from

COR.

Subsequent comments on the draft must be the FDA on IND or IDE issues. Scientific input and advice on these FDA issues shall be provided to DCTD/CTEP staff per established timelines to ensure DCTD/CTEP staff can determine a final decision on how to respond to the FDA by established regulatory timelines.

addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Option Period 1 - Amendment Support (Task 3.4)

Work products and documents related to compiling pertinent data to provide written scientific input and advice to DCTD/CTEP staff on amendments for active select hematologic and solid tumor malignancy trials and PMI sub-studies so DCTD/CTEP can make final decisions on the need for amendments and any required modifications to the amendments before final approval is provided by NCI.

4-weeks after initial request from

COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Option Period 1 - Commentary on New Initiatives and Special Projects (Task 3.12)

As a Subject Matter Expert, the contractor shall provide advice and guidance to CTEP leadership to support their decision making around new initiatives and special projects.

4-weeks after initial request from

COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Option Period 1 - Final Report (Task 3.1)

Report Summarizing activities conducted during the period.

The Final Report shall be an electronic document. Acceptable formats include

3-weeks prior to

Performance.

Subsequent comments on the draft must be addressed within 1-week of receipt after COR approval of finalized draft

OPTION PERIOD 2

Option Period 2 - Monthly Reports (Task 3.1)

Monthly Report detailing activities with allocation of labor hours and identification of work products for the period

All activities specifically related to Tasks 3.5, 3.6, 3.7, 3.8, 3.9, 3.10, & 3.11 shall be addressed in the Monthly Report.

The Monthly Report shall be an electronic document. Acceptable formats include

Option Period 2 -

Support (Task 3.2)

Work products/documents related to compiling pertinent data (including assessment of the supporting pre-clinical and clinical data, patient safety issues, agent side effects, appropriate patient monitoring, and other aspects of patient care) in order to provide written scientific input and advice on selected trial proposals and/or associated correlative ancillary studies. The trial proposals (and/or associated correlative ancillary studies) will be for select hematologic and solid tumor malignancies and PMI sub-studies. Scientific input and advice on the trial proposals shall be provided to DCTD/CTEP staff per established timelines for the NCTN and ETCTN programs to ensure DCTD/CTEP staff can determine the final decision for a proposal and submit that decision and an associated Consensus Evaluation to the appropriate extramural investigators in a timely manner.

4-weeks after initial request from

COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Option Period 2 - FDA Question Support (Task 3.3)

Work products and documents related to compiling pertinent data in order to provide written scientific input and advice on select hematologic and solid tumor malignancies and PMI sub-studies to DCTD/CTEP staff with respect to questions/concerns raised by

4-weeks after initial request from

COR.

Subsequent comments on the draft must be the FDA on IND or IDE issues. Scientific input and advice on these FDA issues shall be provided to DCTD/CTEP staff per established timelines to ensure DCTD/CTEP staff can determine a final decision on how to respond to the FDA by established regulatory timelines.

addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Option Period 2 - Amendment Support (Task 3.4)

Work products and documents related to compiling pertinent data to provide written scientific input and advice to DCTD/CTEP staff on amendments for active select hematologic and solid tumor malignancy trials and PMI sub-studies so DCTD/CTEP can make final decisions on the need for amendments and any required modifications to the amendments before final approval is provided by NCI.

4-weeks after initial request from

COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Option Period 2 - Commentary on New Initiatives and Special Projects (Task 3.12)

As a Subject Matter Expert, the contractor shall provide advice and guidance to CTEP leadership to support their decision making around new initiatives and special projects.

4-weeks after initial request from

COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Option Period 2 - Final Report (Task 3.1)

Report Summarizing activities conducted during the period.

The Final Report shall be an electronic document. Acceptable formats include

4-weeks prior to

Performance.

Subsequent comments on the draft must be addressed within 1-week of receipt after COR approval of finalized draft

HOW TO SUBMIT RESPONSES:

1. Page Limitations:

Interested qualified small business organizations should submit a tailored capability statement for this requirement not to exceed 10 single sided pages including all attachments, resumes, charts, etc. (single spaced, 12 point font minimum) that clearly details the ability to perform the requirements of the notice described above. All proprietary information should be marked as such. Responses should include a minimum of two pages demonstrating experience over the past two years meeting the requirements of this notice. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern’s name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner.

2. Due Date:

Capability statements are due no later than 12:00PM EST on April 27, 2021.

3. Delivery:

The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can perform the requirement. All responses and questions must be in writing and emailed to Lena Lee, Contract Specialist, via electronic mail at lena.lee@nih.gov. Information received will be considered solely for the purpose of determining whether to conduct a small business set-aside. No collect calls will be accepted. In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference: 75N91021Q00070 on all correspondence.

DISCLAIMER AND IMPORANT NOTES:

This notice does not obligate the Government to award a contract or otherwise pay for the preparation of any information submitted. The Government reserves the right to use information provide 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 meet the mailto:lena.lee@nih.gov

Government’s requirements. 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, an RFQ may be published on beta.SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation.