Identify Barriers and Causes of Underrepresentation of Racial and Ethnic Minorities in Clinical Trials

Notice of Intent to Sole Source: Pursuant to the authority of FAR 13.106-1(b)(1)(i), the Contracting Officer may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source is reasonably available. The Department of Health and Human Services (DHHS), Program Support Center (PSC), Acquisition Management Services (AMS) on behalf of PSC, Office of Minority Health (OMH) intends to sole source to: National Academy of Sciences 2101 Constitution Ave NW Washington, DC 20418-0007 The National Academy of Sciences Institute of Medicine (IOM) is uniquely and solely qualified to accomplish the set of tasks outlined in this purchase order due to their singular status with the Federal government as a non-competitive source of scientific research and policy advice since its creation by Congress. The IOM has the ability to convene the level of unbiased expertise and provide authoritative advice that will allow Office of Minority Health (OMH) to advance the important work on the Promotion of Health Equity and the Elimination of Health Disparities report focused on identifying evidence-based strategies to reduce disparities in clinical trials and improve the recruitment and retention of racial and ethnic minorities in these research studies. The IOM applies a distinct research process to provide objective and straightforward answers to questions of national importance. Advice is offered by committees of leading national and international scientists, all of whom serve pro bono, are asked to set aside preconceptions and to rely on evidence as they compose IOM's consensus reports. Most critical to the unique nature of the IOM is that they are exempt from the Federal Advisory Committee Act (FACA), which specifically regulates any committee formed to advise the federal government. The Federal Advisory Committee Act was enacted in 1972 to ensure that advice by the various advisory committees formed over the years is objective and accessible to the public. The FACA formalized a process for establishing, operating, overseeing, and terminating these advisory bodies and created the Committee Management Secretariat to monitor compliance with FACA. The Institute of Medicine is exempt from FACA except for Section 15 of that law. In accordance with federal law and with few exceptions, information-gathering meetings of IOM committees are open to the public, and any written materials provided to the committee by individuals who are not officials, agents, or employees of the National Academies are maintained in a public access file that is available for examination. IOM committees deliberate in meetings closed to the public in order to develop draft findings and recommendations free from outside influences. The IOM is uniquely situated to convene the experts needed to ensure unbiased and evidence-based recommendations are made. They are uniquely able to advise the government - something that is typically limited under the FACA. All information gleaned from this consensus study is available free of charge to the public. In addition, findings and recommendations from the IOM carry the gravitas necessary to ensure that their recommendations are able to be acted on by Federal agencies and other stakeholders. Decades of research have shown that members of racial and ethnic minority groups are more likely to suffer from chronic health diseases such as heart disease, diabetes, and cancer. New treatment advances for these chronic illnesses may not be suitable for members of medically underserved populations due in part by the lack of diversity, inclusion and retention of these groups within clinical trials. The disparate nature of clinical trial participation, past and present, is an imposing challenge identified decades ago. In 1999 the Institute of Medicine (IOM) found that "without a concerted effort to enhance this process [of including ethnic minority and medically underserved populations], ethnic minority and medically underserved communities will continue to lag behind the American majority" in benefiting from the treatment advances resulting from participation in clinical trials. The U. S. Department of Health and Human Services (HHS), Office of Minority Health (OMH) has been long committed to addressing the need of greater representation of racial and ethnic minority groups in clinical trials. OMH's mission is to improve the health of racial and ethnic minorities through the development of health policies and programs that will eliminate health disparities. OMH accomplishes its work through coordination of HHS health disparity programs and activities; assessing policy and programmatic activities for health disparity implications; building awareness of issues impacting the health of racial and ethnic minorities; developing guidance and policy documents; collaborating and partnering with agencies within HHS, across the federal government, and with other public and private entities; funding demonstration programs; and supporting projects of national significance. The Reducing Racial and Ethnic Disparities in Clinical Trials: Moving Beyond the Barriers to Advance Evidence-Based Strategies project aims to develop and disseminate the key findings from the IOM Roundtable workshop, which emphasizes the best practices, implementation strategies, and relevant recommendations for reducing disparities in clinical trials. This is not a solicitation for competitive proposal. No solicitation document is available. All responsible sources that have determined that they can provide the same services may submit product information and a capabilities statement addressing their specific abilities regarding this requirement. The email subject line must reference OS156252. All responses are due by August 20, 2015, 8:00 AM Eastern Time and can be sent to Flora Gomes at contact@example.gov. A determination by the Government not to compete this proposed contract base upon responses to this notice is solely within the discretion of the government.