SOLICITATION NOTICE
B -- Food Allergies: Global Burden, Causes, Treatment, Prevention, and Public Policy: Notice of Intent to Sole Source
- Notice Date
- 4/2/2015
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Program Support Center, Division of Acquisition Management, 12501 Ardennes Avenue, Suite 400, Rockville, Maryland, 20857, United States
- ZIP Code
- 20857
- Solicitation Number
- 15-PSC-NAS151001
- Point of Contact
- Michele Namoski, Phone: 301-443-3337
- E-Mail Address
-
SHELLEY.NAMOSKI@PSC.HHS.GOV
(SHELLEY.NAMOSKI@PSC.HHS.GOV)
- Small Business Set-Aside
- N/A
- Description
- Title: Food Allergies: Global Burden, Causes, Treatment, Prevention, and Public Policy Pursuant to the authority of FAR 6.302-1 The Department of Health and Human Services (DHHS), Program Support Center (PSC), Acquisition Management Services, on behalf of the Food and Drug Administration (FDA),Center for Food Safety and Applied Nutrition(CFSAN), intends to negotiate on a sole source basis, a cost reimbursement order under the PSC Basic Ordering Agreement (BOA) with the National Academy of Sciences, for a study on "Food Allergies: Global Burden, Causes, Treatment, Prevention, and Public Policy". The Institute of Medicine (IOM) is an independent, not for profit organization that works outside of government to provide unbiased and authoritative advice to decision makers and the public. Established in 1970, the IOM is the health arm of the National Academy of Sciences. For more than 140 years, the National Academies have been advising the nation on issues of science, technology, and medicine; ever since an 1863 Congressional charter signed by President Lincoln authorized this non-governmental institution to honor top scientists with membership and to serve the nation whenever called upon. The IOM's reputation as an unbiased source of information is crucial to its acceptance as an authority on questions of science, health, and medicine. The IOM's unique approach to studies ensures that sponsors such as FDA receive independent and authoritative advice. Checks and balances exist at every step to protect the integrity of the reports and to maintain public confidence in their findings. NAS has the unique ability to assemble the Nation's most eminent scholars and other experts, who are appointed by the President of the Academy to provide their expertise without compensation on committees and boards, which render advice and guidance of the highest quality and unparalleled objectivity to address national issues of high priority. The Institutes of Medicine (IOM) have extensive experience convening expert committees from a variety of fields to provide objective, credible, and scientific recommendations addressing food allergies and the global burden, causes, treatment, prevention, and public policy under this proposed study. The IOM's selection of experts draws on nationally known experts in the field, with specific consideration of the overall balance of viewpoints on the committee. Studies are undertaken by distinguished individuals selected for their extensive expertise and experience in the topics under study. The IOM can secure the participation of experts whom it invites to serve. The National Academies work is made possible by 6,000 of the world's top scientists, engineers, and other professionals who volunteer their time without compensation to serve on committees and participate in activities. Accordingly, NAS is uniquely qualified to provide the measure of expertise, independence, objectivity and audience acceptance necessary to meet the program requirements. NAS stands alone in its level of expertise and capacity that is required to complete the proposed study on "Food Allergies: Global Burden, Causes, Treatment, Prevention, and Public Policy". A cost reimbursement order will be negotiated and awarded under the PSC Basic Ordering Agreement with the National Academy of Sciences. The anticipated period of performance shall be for fifteen (15) months from date of award. Food allergies not only affect FA children and their families, but also a wide range of societal settings, including daycare, schools, airlines, military, restaurants, parks, party places, and hospitality industries. The societal and health care economic impact of FA is large and growing, with the estimated annual cost to families in the U.S. at $24.8 billion. Food allergy is further complicated by varied misconceptions within the medical community and the public at large, and by confusing labeling laws. Clearly, in light of the increasing prevalence of FA and its enormous impact on affected individuals, families, and societies, FA can be regarded as a major clinical and public health problem in the U.S. and globally. The National Institute of Allergy and Infectious Disease Expert Panel Report in 2006, Management Guidelines in 2010, and recent international consensus on diagnosis, management, and special issues in FA represent major advancements in the management of FA. However, compared to other major health problems such as asthma, obesity, and diabetes, FA is greatly under-studied and research is under- funded. Further, the current state of understanding of FA is quite limited. As such, the proposed study will be both timely and provide direction for the field. The purpose of this acquisition is for The Institute of Medicine (IOM) shall form a committee to examine critical issues related to food allergy (FA), including the prevalence and severity of FA and its impact on affected individuals, families, and communities; and current understanding of FA as a disease, and in diagnostics, treatments, prevention, and public policy. This consensus study shall engage a broad array of stakeholders, including government agencies, organizations, academic institutions, industries, policy makers, and patient organization groups; to bring together leading investigators f-rom relevant fields, clinicians, and parents; and to develop a framework for future work; and to recommend actions by both government and non-government agencies. The committee's review of the evidence shall consider the following key questions: 1.) What are current trends in FA prevalence? What is an appropriate definition of FA to use in measuring prevalence? What data or methods are most appropriate to use in measuring prevalence and how may they be implemented? Should there be an effort to assess prevalence for allergens other than the 8 most common that are required to be disclosed on food packages? If so, should the same methods be used for these allergens? 2.) What are the key prenatal early life determinants of FA? For example, are there dietary factors that impact development of FA and are these modifiable? 3.) What are the current data gaps in understanding the diagnosis and prognosis for FA? What new approaches are being developed to address these data gaps? 4.) What steps can be taken to educate providers and the public in order to create safe environments for FA children both within and outside the home? What and where are the most risky food scenarios and how can these be better managed? What guidance can be given to individuals about exposure to low levels of allergens in food products? What is the status of assessing allergen thresholds in individuals? What additional methods or tools are needed? 5.) What research gaps need to be filled in order to provide better guidance to health care providers and policy makers? The committee will develop a framework for future direction in understanding FA and its impact on individuals, families, and communities; recommending steps to increase public awareness of FA; promoting research on both disease causation and management; and informing preventive approaches to FA. Research gaps will be identified and recommendations made to fill them. Based on the comprehensive findings of the consensus study, including the committee meetings, background research and other methods, the committee will prepare consensus report which will be the primary product of the study. The sponsors, Congressional members and staff, government agencies, and other relevant organizations will be briefed by committee members on the conclusions and recommendations contained within the final report. All briefings will be planned in consultation with the Office of News and Public Information and the Office of Congressional and Government Affairs. Reports resulting from this effort will be prepared in sufficient quantity to ensure their distribution to sponsors and to other relevant parties, in accordance with Academy policy. The National Academies Press will publish the final report, and will assist in broader dissemination by making the report available on the Internet through the National Academy Press (www.nap.edu). This is not a solicitation for competitive proposals. All responsible sources that have the requisite qualifications to perform the work above may submit a statement of capabilities via e-mail to shelley.namoski@psc.hhs.gov, which will be considered by the agency. The e-mail subject line must reference: 15-PSC-NAS151001 Capability Statement Submission. Responses must be double-spaced with 1" margins on all sides and use a standard font no smaller than 12 point. The statement of capabilities must include: 1.) Cover Letter/Capabilities Statement illustrating organization's technical capabilities and expertise, as it relates to the requirements presented in this notice. 2.) A list of at least 3-5 Past Performance references to include: a.) Description of previous work efforts; b.) Contract number; c.) Point of contact. The response must be sequentially numbered, beginning on the first page after the table of contents. Responses are due by April 17, 12:00 PM (NOON) Eastern Day Light Savings Time. Responses received after the due date and time may not be considered. A determination by the Government not to compete this requirement based upon responses to this Notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive requirement.
- Web Link
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FBO.gov Permalink
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- Place of Performance
- Address: District of Columbia, United States
- Record
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