The Establishment of a Centralized Institutional Review Board (CIRB) to Review Minimal Risk Registry Linkage Studies
Contracting Office Address
Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E226, Bethesda, MD 20892, UNITED STATES.
Non-USPS mail such as Fedex, UPS and other private carriers please use Rockville, MD 20850.
The National Cancer Institute (NCI), Division of Cancer Control and Population Studies (DCCPS), would like to issue a contract with a commercial IRB to serve as a Central IRB (CIRB) for the intake, processing and review of minimal risk registry linkage studies.
This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation: No. N02PC72520-24-01 includes all applicable provisions and clauses in effect through FAR FAC 2005-95 (January 2017) simplified procedures for commercial items.
The North American Industry Classification System code is 541690 and the business size standard is $15.0 million.
Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract with a base year plus four option year periods.
I. Description of Requirement
The Surveillance, Epidemiology, and End Results (SEER) Program is one of the premier cancer surveillance programs in the world being currently composed of population-based cancer registries covering 30% of the total US population. SEER receives approximately 450,000 pathology reports/records annually, and the information collected on each and every cancer patient in SEER coverage areas includes demographics, a description of their cancer, treatment, and patient follow-up including cause of death for deceased patients. Periodic reports on various aspects of the cancer burden on the population including incidence, survival, treatment, and mortality using the SEER database are made available to the general research community and the public, and are routinely cited in the medical literature and the media.
The SEER Program is managed by the Surveillance Research Program (SRP) within the Division of Cancer Control and Population Studies (DCCPS) at the National Cancer Institute (NCI). SRP contracts directly with 14 central registries within the U.S. responsible for the collection of pathology reports and records. Registry staff annotates the required elements into local systems that are then passed into the SEER Data Management System (SEER*DMS). In addition to the contracts directly with registries, SRP also works in a collaborative fashion with The North American Association of Central Cancer Registries (NAACCR) which is the professional organization that develops and promotes uniform data standards for cancer registration and promotes the use of cancer surveillance data and systems.
The purpose of this requirement is to contract with a commercial IRB to serve as a Central IRB (CIRB) for the intake, processing and review of minimal risk registry linkage studies. This need exists in order to streamline the IRB application and review process which is a component of the Virtual Pooled Registry Cancer Linkage System (VPR-CLS) work flow. The contractor must provide evidence of IRB review and approval (or exemption) to initiate the VPR-CLS linkage request process.
Contractor Requirements are:
1. Have a process in place for the expedited review, adjudication and communication of minimal risk studies. This will include:
a. the submission of minimal risk protocols for central cancer registry linkages with cohort studies, clinical trials or other research applications,
b. review processes and timelines, process for requesting changes to a reviewed minimal risk registry study, and
c. the process and timelines for the re-review of modified minimal risk registry linkage studies.
Submissions will be reviewed for completeness and the contractor shall work with the submitting party to resolve any issues around completeness.
2. Have a plan in place to accommodate an increase in the number of minimal risk studies submitted for CIRB review. It is possible that the number of studies can increase by at least 25% per year above the starting estimate of 50 studies. It is also possible that the volume of studies will fall below estimates and the contractor's plan should account for that as well.
3. Create and maintain a review board for the review of minimal risk registry linkage studies. This will include:
a. identification of a Chair,
b. listing of review board members,
c. process steps and timeline for action by the review board for the initial review and,
d. any subsequent re-review of minimal risk registry linkage studies.
The contractor shall ensure that the review board membership has adequate expertise to review submitted studies. The contractor shall appropriately assign reviewers for each review to be conducted including initial review, amendment review, continuing review, etc. While this is not required to be a standing board, the CIRB shall ensure that appropriately qualified members are available without delaying the review.
4. Coordinate, prepare and distribute agendas for all meetings.
5. Coordinate, prepare and distribute meeting packets including agenda and related review materials to CIRB members (which may include members of the VPR-CLS and/or DCCPS leadership teams). This shall include but not be limited to:
a. recording attendance,
b. completion of reviewer assignments,
c. review board members conflict of interest, recusal and meeting quorum per the CIRB SOPs.
6. Document all aspects of the review meetings and prepare minutes of review meetings.
7. Prepare all correspondence related to CIRB meeting review outcomes, including, but not limited to, drafting outcome letters and sending the drafted letters to the Chair for signature, distributing the letters to the appropriate Study personnel (Study Chair, PI, etc.), copying all relevant staff per request or CIRB SOPs.
8. Provide a secure system for the storage of submitted minimal risk registry linkage studies. The system shall restrict access to CIRB members based on role (to be identified by the CIRB). This includes all associated study documents but not limited to:
a. the protocol,
b. correspondence between stakeholders, and
c. any supporting documentation required to render a review and decision.
9. Track CIRB activity related to minimal risk registry linkage studies and provide regular updates to the VPR-CLS leadership team or as requested. The contractor shall recommend tracking statistics it is capable of providing. The contractor shall provide such information with the understanding that the government or VPR-CLS leadership will use it when presenting on minimal risk registry linkage study activity to relevant stakeholders at public meetings.
10. Promote or otherwise post information regarding minimal risk registry linkage study activity on the CIRB's organizational web site. The contractor shall work with the COR to determine what information shall be presented on the web site.
11. Maintain and update annually the CIRB SOPs related to the review of minimal risk registry linkage studies. SOPs for new or revised processes may be drafted/updated more frequently as required. The contractor shall ensure that all applicable CIRB SOPs are in compliance with Federal laws and regulations.
12. Identify CIRB review board members, VPR-CLS/DCCPS leadership, or Study personnel educational needs related to the CIRB process as part of the processing of minimal risk registry linkage study work flow. The contractor shall appraise the government of such educational needs and work with the government to develop, implement, or otherwise share such educational material so as to enhance the effectiveness of the CIRB submission process.
13. Develop and implement a plan as part of the CIRB review process for addressing local context issues as applicable.
14. Maintain AAHRPP accreditation for the duration of this contract.
OPTIONAL TASK
15. Within the first six months following contract award, the Contractor shall develop and submit a draft final transition plan which will describe the Contractor's strategy for transferring work form this contract to a successor contract, in the event a final transition would be required. The plan must include information on the transfer of policies and procedures; transfer of relevant files, records, materials and data; transition of all activities as appropriate. The draft final transition plan will be revised, if necessary, and the draft final transition plan will become the final transition plan upon approval of the COR. The approved final transition plan shall be followed to ensure and orderly, secure, efficient and expedited transition of all contract activities by the contract completion date.
Period of Performance
The period of performance for this contract includes a 12-month base period and four 12-month option periods. The anticipated period of performance shall be 12 months from the date of award.
PLACE OF PERFORMANCE
All work shall be performed at the Contractor's facility.
GOVERNMENT FURNISHED EQUIPMENT
The CIRB shall provide all materials and supplies to conduct the work under this award.
OTHER UNIQUE REQUIREMENTS OR CONSIDERATIONS
The CIRB must have full AAHRPP accreditation and maintain it for the duration of the contract.
INSPECTION AND ACCEPTANCE CRITERIA
NCI will have one month in which to review and accept the specimens and final data. If no comments or request for revisions are provided within one month, the deliverables shall be considered acceptable.
REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE
The contractor will provide five deliverables during the course of this contract. The reports will be provided when work on a specific milestone is completed and vouchers will be submitted for the amount indicated:
o Deliverable 1: Provide a written description of the expedited review process (SOPs) for the review of minimal risk registry linkage studies. This shall be provided in the RFP response and within 15 days of award.
o Deliverable 2: Provide a list of potential reviewers that will participate on the review board for minimal risk registry linkage studies. This shall be provided in the RFP response and within 15 days of award.
o Deliverable 3: Provide a written description of the various tracking statistics captured for assessing the performance of the CIRB for submitted studies. This shall be provided in the RFP response and within 15 days of award.
o Deliverable 4: The contractor shall provide a report of the tracking statistics as well as other pertinent information, to be determined between the COR and the CIRB, representing CIRB activity related to submitted studies on a monthly basis or upon request to the COR. See below for specifics to be included in the monthly report.
o Deliverable 5: Provide a written plan for the posting and promotion of VPR-CLS activities and review statistics on the CIRB's web site. This shall be provided in the RFP response and within 15 days of award.
o Deliverable 6: Provide a written description of any changes anticipated to study review activities, processes, operations, etc. based on changes to HRPP rules. This shall be provided within 30 days of the release or posting of any draft changes to relevant rules.
o Deliverable 7: Provide evidence of current AAHRPP accreditation. This shall be provided in the RFP response and at the time of award. The contractor shall also provide a written plan for the re-accreditation effort should the need for re-accreditation occur during the time this contract is in effect. This shall be provided once the CIRB has developed its reaccreditation plan. The contractor shall notify the COR immediately if there is any change in its AAHRPP accreditation status.
o Final Report: The contractor shall provide a final report using the specified fields listed below and provide within 30 days of contract completion.
Deliverable Name Deliverable Purpose Deliverable Submission Schedule
CIRB SOPs SOPs to inform the government on CIRB operating procedures with respect to the review of minimal risk registry linkage studies. Within 15 days of award. Any modifications or new SOPs required to be submitted at the time it is completed.
List of CIRB Review Board Members To identify reviewers that will participate in the review of minimal risk registry linkage studies including identification of board chair, along with relevant background or specialty information. Within 15 days of award or when the list of reviewers changes.
Tracking statistics elements To identify how and what the CIRB will track related to minimal risk registry linkage study activity. Within 15 days of award of when the list of elements changes.
Monthly report Includes tracking statistics activity and other pertinent information. By the 5th of each month.
Web site plan The web site plan will inform the COR of how the contractor shall post and promote minimal risk registry linkage study activity on its web site. Within 15 days of award or whenever the plan needs to change.
AAHRPP Accreditation Provide evidence of current accreditation status as well as plan for re-accreditation. At time of award for evidence of current accreditation status. Re-accreditation plan shall be submitted when the plan is developed.
Transition Plan To identify and document contractor succession plan. Within six months of award.
Final Plan To document findings, accomplishments, etc. at the conclusion of the contract. Within 30 days of contract completion.
MONTHLY and FINAL REPORT REQUIREMENTS
Monthly Status Report
The Subcontractor shall document the efforts performed in the completion of each task in a detailed Monthly Status Report due within five business days after the start of each Month. It is expected that this report will include, but not be limited to:
• Program status, to include objectives met, work completed and work outstanding
• Notable achievements
• Issues or obstacles impeding progress and recommended solutions
• Status of deliverables/milestones
• Reporting on tracking statistics and related activity
• Issues and resolutions
• Resource planning/status
• Description of work completed and plans for next month including anticipated travel
Final Report
Subcontractor shall submit a Final Report within 30 days of subcontract completion and shall include the following:
• Subcontractor Name and Address
• Name of Person Submitting the Report
• Subcontract Number
• Report Date
• Period Covered by the Report
• A comprehensive Summary of Work performed during reporting period
• Specifics of data quality audit plan
QUESTIONS ARE DUE: June 28, 2017
PROVISIONS AND CLAUSES: The following FAR provisions and clauses apply to this acquisition:
52.212-1 Instruction to Offerors Commercial Items (October 2016)
52.212-2, Evaluation Commercial Items (October 2014)
The technical evaluation will be a determination based on information furnished by the vendor. The Government is not responsible for locating or securing any information which is not identified in the proposal. The Government reserves the right to make an award without discussions.
a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:
1. Demonstrated experience and capabilities of essential personnel (30 points)
2. Demonstrated experience and capabilities of other personnel (15 points)
3. Technical approach (35 points)
4. Managerial Approach (15 points)
5. Facilities and Equipment (5 points)
6. Cost/price
All evaluation factors other than cost or price when combined, are significantly more important than cost or price.
b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).
c) A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.
FAR 52.212-3, Offeror Representations and Certifications - Commercial Items (October 2016) - with Addenda [Representation By Corporations Regarding an Unpaid Delinquent tax Liability or a Felony Conviction Under Any Federal Law and FAR 52.204-6, Unique Entity Identifier (October 2016)]
FAR 52.212-4, Contract Terms and Conditions - Commercial Items (May 2015) - With Addenda
FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (November 2016)
The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:
FAR 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995)
FAR 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016)
FAR 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015)
FAR 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013)
FAR 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014)
FAR 52.219-8, Utilization of Small Business Concerns (Nov 2016)
FAR 52.219-28, Post Award Small Business Program Representation (Jul 2013)
FAR 52.222-3, Convict Labor (June 2003)
FAR 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Oct 2016)
FAR 52.222-21, Prohibition of Segregated Facilities (Apr 2015)
FAR 52.222-35, Equal Opportunity for Veterans (Oct 2015)
FAR 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014)
FAR 52.222-37, Employment Reports on Veterans (Feb 2016)
FAR 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010)
FAR 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011)
FAR 52.225-13, Restrictions on Certain Foreign Purchases (June 2008)
FAR 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Jul 2013)
FAR 52.222-17, Nondisplacement of Qualified Workers (May 2014)
Full text copies of the representations and certifications for other cited provisions and clauses may be obtained on line at the NCI website at http://ncioa.cancer.gov/oa-internet/reference.jsp or from Kimesha Leake, Contracting Specialist at Kimesha.leake@nih.gov
OFFERORS: Offers must be submitted with a completed 52.212-3 Offeror Representations and Certifications-Commercial Items-with DUNS Number Addendum, signed by an authorized representative of the offeror OR provide a copy of the valid SAM registration through www.sam.gov.
Quotations must be received in the NCI-OA contracting office by 5:00 p.m. EST on July 6, 2017. Please refer to solicitation number N02PC72520-24-01 on all correspondence. Faxed quotations will NOT be accepted. Quotations may be submitted via email to Kimesha Leake, Contract Specialist at Kimesha.leake@nih.gov
All questions shall be in writing and may be addressed to the aforementioned individual noted above. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management through sam.gov.
BASIS FOR AWARD:
1. GENERAL
Selection of an offeror for contract award will be based on an evaluation of proposals against four technical evaluation factors. The factors in descending order of importance are: technical, cost, past performance, and Small Disadvantaged Business (SDB) participation. Although technical factors are of paramount consideration in the award of the contract, past performance, and cost/price are also important to the overall contract award decision. All technical evaluation factors other than cost or price, when combined, are significantly more important than cost. The Government intends to make an award to that offeror whose proposal provides the best overall value to the Government. The Government will be using assigned weights in evaluating all proposals.
The evaluation will be based on the demonstrated capabilities of the prospective Contractors in relation to the needs of the project as set forth in the RFQ. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements within the RFQ. In addition, the offeror should provide context to demonstrate their understanding of the overall project requirements; and a description of their approach to provide integrated support across the entire breadth of the proposal to meet all the requirements.
Offerors must submit information sufficient to evaluate based on the detailed criteria listed below.
2. COST/PRICE EVALUATION
Offeror(s) cost/price proposal will be evaluated for reasonableness. For a price to be reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market. Normally, price reasonableness is established through adequate price competition, but may also be determined through cost and price analysis techniques as described in FAR 15.404.
3. TECHNICAL EVALUATION CRITERIA (100 Points)
The evaluation criteria are used by the technical evaluation committee when reviewing the technical proposals. The criteria below are listed with weights assigned for evaluation purposes.
A. DEMONSTRATED EXPERIENCE AND CAPABILITIES OF ESSENTIAL PERSONNEL.............................................................................30 points
Appropriateness, adequacy, and relevance of the education, training, experience, expertise, qualifications, and availability for the proposed senior level personnel of the Offeror in relation to the implementation, conduct, monitoring and completion of the requirements identified in the Statement of Work, including the responsibilities and level of effort for all proposed personnel who will be assigned to the contract, their time commitment, as well as proposed subcontractors and consultants.
1. Project Manager/CIRB Administrator:
• Documented qualifications, knowledge, experience, education, competence, and availability in administrative and personnel management of similar structurally-complex central IRB projects successfully, completed on-time, and within or under budget.
• Documented qualifications, knowledge, experience, education, competence, and availability in managing projects of similar size and scope to the CIRB initiative.
• Documented qualifications, knowledge, experience, education, competence, and availability in training new staff or new reviewers, and in coordinating all aspects of the project to proceed effectively as one organization.
• Documented demonstrations of experience in designing and monitoring process for quality assurance related to IRB activities and responsibilities.
B. DEMONSTRATED EXPERIENCE AND CAPABILITIES OF OTHER PERSONNEL..............................................................................15 points
1. Administrative Personnel:
• Demonstrated experience and expertise in managing scheduled and ad-hoc meetings, ensuring timeliness and accuracy of posted review documents, while ensuring compliance with regulations and relevant SOPs.
• Demonstrated adequacy of approach for assisting IRB members, Study Chairs, and sponsor with meeting and review requirements.
• Demonstrated adequacy of approach for communicating with investigators or investigator staff regarding protocol submission, review and/or decision.
2. IT Support:
• Demonstrated ability to develop data tracking systems with capabilities for
editing, quality control and documentation, and provision of reports.
• Demonstrated experience, expertise, and capability in web design and maintenance.
C. TECHNICAL APPROACH............................................................35 points
Demonstrate adequacy, appropriateness, and feasibility of the proposed technical approach that details process and procedures for planning and conducting central IRB review meetings and assisting institutions to complete the requirements to use the CIRB, including organization and staffing to ensure efficient planning, initiation, implementation, conduct, and completion of all activities in the Statement of Work, and knowledge about regulations pertaining to IRB reviews and processes. Specifically, the Offeror shall provide evidence of demonstrated current and past experience in the following capabilities using their own personnel. The Offeror shall demonstrate their understanding and provide their recommended approach (i.e. the ‘how') to each major project task area. Of critical importance, the Offeror shall also demonstrate their regulatory and operational understanding of the ‘why' behind each task area
1. Adequacy of the transition-in plan to ensure the orderly, efficient and safe transition of all contract activities and materials.
2. Documented ability and appropriateness to efficiently and effectively:
• Conduct IRB meetings
• Support operations with Information technology (IT) systems to increase efficiency and accuracy
• Maintain and improve web design specific to web pages used for this project
• Develop, implement, and document quality assurance procedures for all processes, including the draft proposal submission
• Develop coordination and liaison with collaborating investigators or institutions as they complete requirements to open a study
3. Demonstrate an understanding of the operations and structure of key stakeholders in this project, specifically the NCI's Surveillance Research Program, the Surveillance, Epidemiology and End Results (SEER) program, the North American Association of Central Cancer Registries (NAACCR), and the Association for Accreditation of Human Research Protection Programs (AAHRPP).
4. Appropriateness of the challenges, risks and opportunities to CIRB initiative identified and adequacy of the solutions provided.
5. Adequacy of Initiative-wide Quality Improvement plan.
6. Documented ability to simultaneously manage multiple requests for assistance via the helpdesk.
7. Adequacy of a back-up plan for dealing with difficulties such as unforeseen and planned absence of key personnel, security breaches, equipment failure. Particular emphasis will be placed on innovation in approach, as applicable.
8. Suitability of systems proposed for tracking project activities and monitoring progress, timelines and budgets.
9. Suitability of the plan for establishing lines of communication between the contractor, the NCI COR, and the Contracting Officer, as well as lines of communication with CIRBs, Study Chairs, and the investigators who have submitted protocols for review.
10. Adequacy, appropriateness, and feasibility of the proposed processes and procedures for managing any subcontractors.
11. Phase-Out transition
• Capability to successfully complete all SOP responsibilities.
• Demonstrated ability of the transfer of and orientation to all IT support including but not limited to reporting databases, IRBManager, and the CIRB website.
• Capability to introduce CIRB members and impacted investigators to new Contractor.
• Perform any additional tasks for which the new Contractor requests orientation.
D. MANAGERIAL APPROACH........................................................15 points
The Offeror should provide evidence of demonstrated managerial experience relevant to the work described in the Statement of Work in the following capabilities:
1. Demonstrated appropriateness of the Project Director in relation to the organizational structure of the Offeror and the tasks described in the Statement of Work.
2. Demonstrated adequacy of staffing plan, responsibility, and lines of authority to coordinate efforts of and retain key personnel to carry out the proposed Statement of Work and plan to manage the work of consultants and/or subcontractors, if applicable.
3. Demonstrated plan to manage multiple CIRB reviewers, investigators and submitted protocols in a widespread geographic area.
4. Demonstrated adequacy of approach for providing back-up support personnel for emergent, high-priority requests.
5. Demonstrated ability to have frequent face-to-face meetings between key contract staff (Project Manager and/or Study Managers) and the NCI COR or study investigators to conduct a careful review of status, progress, and expenses associated with ongoing projects and to discuss future activities and needs. Meetings may be facilitated by teleconference, video conference, etc., as appropriate to the activity.
6. Demonstrated adequacy of plan for quality assurance plans for data and security against physical damage, loss, and unauthorized use.
7. Demonstrated adequacy of plan for monitoring the progress of subcontracted work.
8. Demonstrated adequacy of corporate approach to minimizing errors in deliverables, and policy on charges if work must be produced a second time due to errors in the initial deliverables.
9. Demonstrated availability of, or ability to recruit on an as-needed basis, personnel that may be required for the conduct of this project. These personnel shall have adequate and appropriate training, experience, qualifications, and availability to perform the function required.
F. FACILITIES AND EQUIPMENT.....................................................5 points
Documented capacity, adequacy, suitability and availability of the proposed facilities, equipment, and other resources necessary to carry out the requirements specified in the Statement of Work:
1. Availability and adequacy of secure area for storage of study materials and back-up data with access for only appropriate staff.
2. Adequacy of data processing and storage capability including back-up data and security of data files.
3. Capability of telephone helpdesk center.
TOTAL AVAILABLE POINTS: 100
5. PAST PERFORMANCE FACTOR
Offeror's past performance information will be evaluated subsequent to the technical evaluation. However, this evaluation will not be conducted on any offeror whose proposal is determined to be technically unacceptable.
The evaluation will be based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken.
The Government will assess the relative risks associated with each offeror. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance.
The assessment of performance risk is not intended to be a product of a mechanical or mathematical analysis of an offeror's performance on a list of contracts but rather the product of subjective judgment by the Government after it considers relevant information.
When assessing performance risks, the Government will focus on the past performance of the offeror as it relates to all acquisition requirements, such as the offeror's record of performing according to specifications, including standards of good workmanship; the offeror's record of controlling and forecasting costs; the offeror's adherence to contract schedules, including the administrative aspects of performance; the offeror's reputation for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the offeror's business-like concern for the interest of the customer.
The Government will consider the currency and relevance of the information, source of the information, context of the data, and general trends in the offeror's performance.
The lack of a relevant performance record may result in an unknown performance risk assessment, which will neither be used to the advantage nor disadvantage of the offeror.
6. EXTENT OF SMALL DISADVANTAGED BUSINESS PARTICIPATION
SDB participation will not, be scored but the Government's conclusions about overall commitment and realism of the offeror's SDB Participation targets will be used in determining the relative merits of the offeror's proposal and in selecting the offeror whose proposal is considered to offer the best value to the Government.
The extent of the offeror's Small Disadvantaged Business Participation Targets will be evaluated before determination of the competitive range. Evaluation of SDB participation will be assessed based on consideration of the information presented in the offeror's proposal. The Government is seeking to determine whether the offeror has demonstrated a commitment to use SDB concerns for the work that it intends to perform.
Offers will be evaluated on the following sub-factors:
a. Extent to which SDB concerns are specifically identified;
b. Extent of commitment to use SDB concerns;
c. Complexity and variety of the work SDB concerns are to perform;
d. Realism of the proposal;
e. Past performance of offerors in complying with subcontracting plan goals for SDB concerns and monetary targets for SDB participation;
f. Extent of participation of SDB concerns in terms of the value of the total acquisition.
7. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY - SECTION 508
The offeror's proposal must demonstrate compliance with the "Electronic and Information Technology Accessibility Provisions" set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the "Access Board") in 36 CFR part 1194 for all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this contract/order, including EIT deliverables such as electronic documents and reports.
If your proposal does not include a completed HHS "Section 508 Product Assessment Template" (hereafter referred to as the "Template") which demonstrates that EIT products and services proposed support applicable Section 508 accessibility standards, or, if the completed "Template" included in your proposal is considered "noncompliant," and the Government includes your proposal in the competitive range (for competitive proposals), or if the Government holds discussions with the selected source (for sole source acquisitions), you will be afforded the opportunity to further discuss, clarify or modify the "Template" during discussions and in your Final Proposal Revision (FPR). If your "Template" is still considered "noncompliant" by the Government after discussions, your proposal may not be considered further for award.
8. SUSTAINABLE ACQUISITION PLAN
The Offeror's proposal must demonstrate compliance with FAR 23.1, "Sustainable Acquisition Policy" and the interim rule entitled "Sustainable Acquisition" at http://www.gpo.gov/fdsys/pkg/FR-2011-05-31/pdf/2011-12851.pdf (FAR case 2010-001, FAC 2005-52). If the proposal does not include a Sustainable Acquisition Plan that addresses the environmental products and services to be utilized under the resulting contract, or if the Plan is considered to be "poor" and the Government includes your proposal in the competitive range, the Offeror will be afforded the opportunity to further discuss, clarify, or modify the Plan during discussions and in their Final Proposal Revision (FPR). The Government is seeking to determine whether the Offeror has demonstrated a commitment to advance sustainable products and services.
The following evaluation criterion will be used in review of the Sustainable Acquisition Plan:
Descriptor Proposal qualities
Excellent Documents compliance with relevant environmental laws and regulations to acquire supplies and services that promote energy and water efficiency, advance the use of renewable energy products, and help foster markets for emerging technologies. Implements cost- effective contracting preference programs promoting energy- efficiency, water conservation and the acquisition of environmentally preferable products and services (e.g., computer monitor, desktop computer, notebook computer and personal computer products. Minimizes the procurement of materials and substances that contribute to the depletion of stratospheric ozone. Gives preference to the procurement of alternative chemical, product, and manufacturing processes that reduce overall risks to human health and the environment by lessening the depletion of ozone in the upper atmosphere. Reduces paper use and acquires paper containing at least 30% postconsumer fiber.
Good Documents compliance with relevant environmental laws and regulations and commits the organization to more aggressive actions such as: Develops and implements innovative policies and practices to reduce scope 3 GHG emissions in HHS operations. Manages existing buildings to reduce energy, water, and materials consumption. Implements and achieves objectives in EPA's Storm water Management Guidance. Reduces paper use and acquires paper containing at least 30% postconsumer fiber. Minimizes the acquisition, use, and disposal of toxic and hazardous materials. Employs environmentally sound practices for the disposition of all agency excess or surplus electronic products. Procures Energy Star and FEMP-designated electronic equipment. Continues implementation of existing Environmental Management System (EMS) programs.
Fair Documents existing programs that meet relevant environmental laws and regulations and proposes modest further steps.
Poor Merely states that the offeror will comply with relevant environmental laws and regulations, or describes programs that merely comply with relevant laws.
Kimesha Leake, Contract Specialist, Phone 2402765669, Email kimesha.leake@nih.gov - Jolomi Omatete, Contract Specialist, Phone 2402766561, Email jolomi.omatete@nih.gov
