16-233-SOL-00461_-_Attachement_1_Revised_7-11-2016.pdf

16-233-SOL-00461 – Attachment 1

Statement of Work Division of Education and Development (DED)

Office for Human Research Protections Division of Education and Development

DED Educational Conferences and Events Planning Services

Introduction

The Office for Human Research Protections (OHRP) is seeking a contractor to assist it in developing and implementing a number of activities critical to upholding OHRP’s regulatory mandate to provide leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). Among other things, OHRP maintains regulatory oversight of the Department of the HHS Protection of Human Subjects Research regulations found at 45 CFR part 46 and provide the entities it regulates with clarification and guidance and advice on ethical and regulatory issues in biomedical and social-behavioral research. The Contractor shall provide technical and consultant support services.

Background

Several reports on the need to increase the level of protection for human subjects in biomedical and behavioral research were issued by the Inspector General’s Office at the Department of Health and Human Services, the U.S. General Accounting Office, and the National Bioethics Advisory Commission. In addition, several congressional hearings and public interest have intensified the level of concern regarding the adequacy of protection of human research subjects.

Among the mechanisms OHRP utilizes to meet its statutory and regulatory mandates are:

developing, maintaining and updating training programs and information resources to educate a highly diverse group of stakeholders involved in the research enterprise, on the regulatory and ethical issues on human research protections; and, facilitating the effective and efficient communication and dissemination of OHRP’s educational resources. The Division of Education and Development (DED) within OHRP has the responsibility for educating both federal and non-federal sectors on the regulatory and ethical issues regarding the protection of human subjects in research. OHRP/DED anticipates planning, developing, and implementing a number of activities critical to upholding OHRP’s educational mandate.

Purpose

The purpose of this contract is to provide technical and logistic support services for educational conferences, workshops and webinars which are essential to DED fulfilling its mission in educating and informing the public on human research protections.

The contractor will be responsible for successfully performing the deliverables described below.

The Contract Officer’s Representative (COR) will oversee the progress of the contract, and will work closely with the contractor to ensure completion of all tasks.

Work Requirements

Independently, and not as an agent of the Government, the Contractor shall furnish the necessary personnel, materials, services, and otherwise do all things necessary for or incidental to the performance of the work in this contract and produce the deliverables identified in the respective task objectives. The COR will review and approve all contract deliverables. The tasks are outlined in this contract, with a period of performance of twelve months from the effective date of the contract unless where stated otherwise.

The contractor shall designate a qualified Management Coordinator (MC) who is responsible for acting as liaison with the Office for Human Research Protections (OHRP) COR. The MC shall meet with the COR to get an overview of the activity objectives and purposes and to ascertain the types of personnel and equipment/material services needed and corresponding timeframes/deadlines and requirements for each needed service. The MC shall present to the OHRP COR an itemized plan for how each of the needed services shall be carried out. The plan shall show that potential problems have been anticipated and mechanisms have or shall be put in place to prevent such problems. The MC shall prepare a pre-activity budget estimate and submit it to the COR for review and approval. The contractor should be thoroughly knowledgeable of the Federal Acquisition Regulation (FAR) requirements pertaining to allowable and non-allowable costs.

The contractor and OHRP/DED will have the first meeting to discuss overall strategic plan for required activities by September 23, 2016.

Throughout all stages of the activities MC shall keep in close contact with the OHRP COR, apprising her/him of problems and solutions, and of the status of the services. The contractor shall be responsible for changes and be able to adjust plans throughout every stage of the requested activities on short notice.

A monthly report will be provided to the COR by the tenth of each month. The report shall describe work performed under each Task. The report shall include the following information as appropriate:

1. Breakdown of work accomplished (including labor hours)

2. Tasks planned for each individual activity

3. Potential problems/planned solutions

4. Areas requiring resolution within OHRP

5. Comprehensive budget information per task

5. Financial Status – including detailed information showing the balance of funds remaining as of the date of the report

Task

Educational Conferences and Events Planning Services

DED plans, develops, implements, evaluates and co-sponsor educational events that include conferences, educational workshops and webinars. Technical and logistical support shall be provided to OHRP/DED by the contractor in support of the above mentioned activities. The following is a list of expertise/resources/services that have been used in the past and shall be required in the future to support DED’s conference initiative.

Conference and events planning services to include but are not limited to the following components:

1. Project management

2. Site location research, reservation of facilities and accommodations

3. Liaison and coordination for venue, AV and IT support as appropriate

4. Registration website development, on-site meeting and registration support

5. Automation and telecommunications support

6. Communications with attendees, speakers etc.

7. All meeting logistics support, as well as pre- and post- meeting support

8. Live broadcast support, video recording, close captioning

9. Professional transcripts

10. 508-compliance related activities

11. Coordination and implementation of 3rd party engagement

12. Management of 3rd party payment for engagement

Deliverables

During the period of the contract, DED expects contracting support for

Hosting one full day conference in the D.C. metropolitan area that will also be webcast live

Making OHRP co-sponsorship payments of up to $12,000 to co-sponsoring institutions Making payment of accreditation fees for OHRP workshops of up to $950 Obtaining transcripts for OHRP conducted webinars and others

Contractor Quality Control

The Contractor shall establish and maintain an inspection system.

Contractor performed inspections are independent of those performed by the COR. The Contractor shall perform his inspections prior to requesting acceptance of the work by the COR.

Technical Evaluation Criteria

The major evaluation factors for this solicitation include technical (which encompasses experience and past performance factors) cost/price factors. Although technical factors are of paramount consideration in the award of the contract, cost/price is also important to the overall contract award decision. All evaluation factors other than cost or price, when combined, are significantly more important than cost or price. In any case, the Government intends to make an award(s) to that offeror whose proposal provides the best overall value to the Government.

The evaluation will be based on the demonstrated capabilities of the prospective Contractors in relation to the needs of the project as set forth above. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements listed above. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria listed below.

1. Understanding of the Problems and the Technical Approach 40 pts

2. Past Performance and Corporate Experience 40 pts

3. Qualifications of Management and Proposed Staff. 20 pts 100 pts

1. Understanding of the Problems and the Technical Approach (40 pts)

Offerors shall be evaluated on the basis of demonstrated understanding of the objectives and requirements of the Statement of Work. The offeror will describe the objectives that will be accomplished through defined phases of work. The following subfactors are of equal importance:

a) The offeror’s understanding of OHRP/DED’s overall mission of promoting human research protections, as well as DED’s vision through effective communication and outreach, and innovations in the delivery of education and information in fulfilling its mission.

b) An acceptable action plan which outlines each program/project area listed in the SOW and reflects the careful planning, organization, systemic and detailed tracking of deliverables and price, realistic and knowledgeable phase development, and service/product development and delivery.

c) Documentation of the ability to provide high quality performance of all areas of support required by the Statement of Work.

d) Adequacy of specific plans for quality assurance and evaluation of services provided under this requirement. Adequacy of plans for ensuring an effective interaction with the COR and other HHS/OHRP/DED staff as necessary and for timely responses to requests.

e) Technical expertise and managerial experience in providing support for similar activities especially for offices within the HHS/NIH.

2. Past Performance and Corporate Experience (40 pts)

When assessing performance risks, the Government will focus on the past performance and corporate experience of the offeror as it relates to the following subfactors which are of equal importance:

a) The offeror’s record of performing according to contract specifications, including compliance with contract requirements, prompt provision of invoices and accurate reports of expenditures, records of controlling and forecasting costs as well as technical proficiency and excellence.

b) Demonstrated corporate experience in strategy development, project management, needs assessment, program design, program development, and program implementation for a federal government agency/office involved in biomedical and socio-behavioral research and related policies.

c) Corporate experience in the technical areas covered by this proposal including efficient and effective recruitment, engagement and/or remuneration of quality SMEs, demonstrated capacity and track record to handle the invoices from 3rd parties and be able to approve and make payments promptly and within a reasonable time of a month of less; expert logistical support for meetings and events including managing video teleconferencing and live webcasts. It is vital that the offeror has a good track record of responding promptly and adequately to questions and requests from the COR on the different tasks.

d) Ability to deliver a well-coordinated team of knowledgeable staff appropriate for projects and services in addition to having the corporate flexibility to leverage additional resources as needed to supplement any talent gaps identified during this period.

3. Qualifications of Management and Proposed Staff (20 pts)

The following sub-factors are of equal importance:

a) Documented successful prior experience of proposed management personnel in similar activities of comparable scope and complexity.

b) Documented experience and skills of proposed staff to provide technical, creative and management expertise necessary to the successful performance of each required phase.

c) Ability of proposed staff to identify and successfully solve problems and meet short deadlines.

d) Experience with management of personnel when many staff are needed to work on programs and services simultaneously or concurrently to achieve the scope of work in the timeframe required – coordinated effort to share knowledge and information between members to avoid duplication of efforts.

e) Documented experience, knowledge and skills of proposed staff to recommend and facilitate collaborative partnership with other federal offices (such as NIH Institutes and Centers, NSF etc) that have a direct or indirect interest in human research protections.

Period of Performance

September 15, 2016 – September 14, 2017