STATEMENT OF WORK for Biosafety Program

Attachment 1

STATEMENT OF WORK

Biosafety Outreach program

Development and Maintenance

BACKGROUND:

The Office of Biotechnology Activities (OBA), located within the Office of the Director (OD), National Institutes of Health (NIH), is the focal point within the U.S. Department of Health and Human Services (DHHS) for addressing the scientific, ethical, legal, and societal issues raised by advances in biotechnology research. OBA activities fall into several program areas: recombinant DNA research (including human gene transfer), genetics and society, biosecurity in the life science research and clinical research policy and analysis. A critical objective in OBA’s mission is to gather, evaluate, and disseminate information regarding developments in these arenas of biomedical research.

Within the scope of this project, the contractor shall provide technical and scientific advice and guidance to OBA on the design and implementation of programs that enhance understanding of the NIH requirements that pertain to the oversight of research involving recombinant DNA, and the emerging federal policies related to research with dual use potential.

SCOPE OF WORK:

The contractor shall perform the following tasks:

· Coordinate the development and implementation of national and regional programs involving education and outreach strategies relevant to the oversight of recombinant DNA research and other OBA program areas;

· Establish and maintain strong lines of communication between OBA and the research and patient communities (including investigators), Institutional biosafety Committees (IBCs), Institutional Animal Care and Use Committees (IACUCs), Institutional Review Boards (IRBs), academic and industrial research administrators, patients and advocacy organizations. In addition, the contractor shall enhance liaison with program officers and executive officials at the NIH Institutes and Centers and other federal agencies such as the Food and Drug Administration, the Centers for Disease Control, DHHS Office of Human Research Protections, and the United States Department of Agriculture.

· Identify points of emphasis in education activities by conducting assessments of various areas of compliance to include general compliance with biosafety review requirements of the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines), clinical investigator compliance with Appendix M of the NIH Guidelines and the protocol submission process, IBC compliance with registration and annual reporting requirements, and institutional compliance with reports of problems, accidents or violations of the NIH Guidelines.

· Develop and implement strategies to stimulate enhanced communication between IBCs, IACUCs and IRBs relevant to OBA program areas, as well as to improve interaction and cooperation with national advocacy and voluntary organizations, scientific and professional organizations and federal agencies. Such strategies include conducting meetings and seminars and developing correspondence and communications systems to disseminate information.

· Serve as the key point of contact with the research and patient communities. Receive input about important issues, concerns, challenges related to NIH biosafety requirement in order to identify points of emphasis in OBA’s education programs. Respond to inquiries and develop and provide information on the OBA biosafety and biosecurity programs. Perform strategic analyses of public information needs and develop initiatives to ensure timely dissemination of information based on target audiences, e.g., lay public, news media, scientific research community, Congress and other local, state and federal agencies.

· Conduct research and gather informational materials that may be of use in various educational activities; synthesize materials to make them more accessible to OBA staff, committee members, and other end users. Oversee the development of educational materials such as a web page for IBCs, to convey key compliance information and aid in the understanding and interpretation of the NIH Guidelines.

· Review and coordinate informational materials and products associated with external communications initiatives to include talking points, statements, briefing papers, fact sheets, news releases, reports, agendas, copy for printed informational products, notices for the web and listserv, and PowerPoint slides for presentations.

· Initiate, coordinate, and manage an awareness campaign to build customer relationships and enhance communications to provide educational opportunities and create a sense of professional community among IBC members, chairs, and staff. Conduct workshops and presentations at national and regional meetings, seminars and conferences to convey information about the NIH Guidelines and other OBA activities. Organize and conduct focus groups to determine public information needs for the purpose of designing, re-designing and/or enhancing OBA databases and informational products.

· Serve as a key member of a team that conducts site visits to evaluate institutional compliance with the NIH Guidelines, evaluates findings and prepares detailed report of findings with recommendations to improve deficiencies. The contractor will serve as an expert consultant on the requirements in institutions and IBCs under the NIH Guidelines. Participation in these site visits will present the OBA perspective.

· Provide biosafety expertise in OBA discussions of biosafety policy matters.

DELIVERABLES:

The deliverables under this contract shall be:

· Site visit assessment reports;

· Development and presentation of slide presentations;

· Development of FAQs;

· Development of educational materials and artwork concepts for the various OBA exhibits;

· Conducts and reviews compliance problems;

· Conducts and reviews incidence reports and sends letters to institutions.

GOVERNMENT RESPONSIBILITIES:

The work shall be performed at the OBA office, 6705 Rockledge Drive, Suite 750, Bethesda, MD. Therefore, the Government will provide all equipment and supplies necessary that are usual and customary in an office setting.

OWNERSHIP:

All materials developed, and equipment and supplies provided, under the scope of this contract are the sole property of the Federal Government.

REPORTING REQUIREMENTS:

The contractor shall report directly to TO BE DETERMINED (TBD) AT TIME OF CONTRACT AWARD. _________will serve as the technical project officer and provide an overview of all work products and advice and guidance on work processes and methodologies.

The contractor shall provide OBA with monthly financial reports detailing expenditures and other reasonable costs incurred under the contract and will invoice accordingly.

TBD AT TIME OF CONTRACT AWARD will serve as the overall project officer on this contract, reviewing all invoices and reports and ensuring reasonable costs.