Genetic Study of ADHD in North America
Department of Health and Human Services, National Institutes of Health | Published December 5, 2014 - Deadline December 12, 2014
THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).
THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED.
The National Institute of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA), Office of Management on behalf of the National Human Genome Research Institute, (NHGRI), intends to negotiate and award a purchase order on a non-competitive sole source basis to Children's National Medical Center, 111 Michigan Avenue, NW, Room 1950, Washington, DC 20010 to provide consultation services on a genetic study of Attention Deficit/Hyperactivity Disorder in North America.
The National Institutes of Health (NIH) mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The National Human Genome Research Institute (NHGRI) mission has expanded to encompass a broad range of studies aimed at understanding the structure and function of the human genome and its role in health and disease. To that end NHGRI supports the development of resources and technology that will accelerate genome research and its application to human health. A critical part of the NHGRI mission continues to be the study of the ethical, legal and social implications (ELSI) of genome research.
Medical Genetics Branch (MGB) seeks to identify and understand inherited disorders of metabolism and of human development. MGB investigators focus on human genetics, vertebrate embryology, inborn errors of metabolism, and neurogenetic disorders. Projects performed at the biochemical, molecular, and cell biological levels involve the direct study of human subjects as well as the development and use of experimental model systems, such as zebrafish and mouse. The Branch fosters outstanding basic research and serves as a model for translational discoveries at the bedside. Branch researchers develop and test new diagnostic tests and treatments for patients with rare genetic disorders in the NIH Clinical Center. Muenke's research program seeks to improve knowledge about birth defects and normal and abnormal early embryogenesis with special emphasis on the central nervous system, cardiovascular system, and reproductive system. Major areas of focus involve holoprosencephaly (HPE), attention deficit hyperactivity disorder (ADHD), craniosynostosis, congenital heart disease (CHD), and sex chromosome anomalies.
Attention Deficit Hyperactivity Disorder (ADHD) is the most common behavioral disorder of childhood, affecting approximately 5-10 % of children between the ages of 7 and 18 years of age. Up to 40% of children with this condition will continue to have symptoms and impairments during adulthood. It is extensively recognized that patients with ADHD have higher risk for poor education, lower income, increased risk for accidental injuries, and a higher risk of difficulties in social interaction. The impact of this condition on the individual and on society in general has been extensively characterized.
The NIH National Human Genome Research Institute (NHGRI) seek to collaborate and award a provide a purchase order to a highly qualified Child Neurologist from the Department of Neurology at Children's National Medical Center (CNMC) with extensive expertise in clinical and genetic research in ADHD. The Contractor shall provide evaluations of patients and families with diagnosis of ADHD as well as support the collaborative efforts with the MTA study group and any other groups collaborating in NHGRI ADHD research. The Center for Neuroscience and Behavioral Neurology at Children's National Health System (CNMC) is part of the Children's Research Institute. This Center has extensive expertise in clinical care and research in multiple medical conditions, including ADHD. Several studies on ADHD are currently in progress at this Center. A devoted team of neurologists with extensive expertise in multiple areas in neurology and behavioral science are available at this institution. The Department of Neurology at CNMC has an extensive record of cooperation and participation in research studies in multiple areas. It is the largest Child Neurology/pediatric practice in the area, and serves the greater Washington, DC/Maryland/Northern Virginia region through outpatient centers located at the CNMC main campus, as well as through its Regional Outpatient Centers and a number of satellite offices. The proximity to the NIH is very important for this study.
In terms of NHGRI specific research interest, it is widely recognized that ADHD is a genetic condition, with a high rate of association in family members. When the rate of illness in relatives of ADHD probands is compared to the rates of ADHD in controls, it is clear that first and second-degree relatives of ADHD probands are at increased risk for the disorder. A Pediatric Neurologist from the Children National Medical Center with extensive expertise in the clinical management and in research on the mechanisms of ADHD has been fundamental to guarantee that NHRGI clinical evaluations comply with the phenotypic definitions in the study, act as liaison with the MTA study group and support further collaborations that can advance researchers understanding of the biological-genetic mechanisms implicated in ADHD diagnosis and prognosis. A Child Neurologist with expertise in ADHD in clinical and Genetic research is necessary to act as a Medical Director for this study. The National Medical Center has previous knowledge and expertise interacting and collaborating with NIH/National Human Genome Research Institute.
WORK SCOPE AND OBJECTIVES:
NHGRI Researchers have interviewed families of children affected with ADHD who have one or more siblings, after obtaining informed consent/assent and determining that their family structure and history make them suitable candidates for a genetic study. It is estimated that for the whole study, 5,000 probands and one or more of their siblings will be interviewed by telephone over several years from different sites in the United States. The research study to date has enrolled 1400 families. To be eligible for the studies, affected individuals must meet the stringent exclusion/inclusion criteria established at an NIH Conference on ADHD in April 1999. To ensure that the ADHD seen in research participants is not part of another syndrome, participants are tested using approved and standardized psychological instruments. During the past years, NHGRI research team has been highly successful in conducting the screening and evaluation of these families. A highly qualified group of health professionals with extensive expertise in ADHD and clinical research has been fundamental in the progress of this study. An extensive clinical interview has been performed, largely via phone interviews, allowing us researchers to include study patients from all 51 United States. The successful study relies on the ability to have a proper clinical diagnosis despite the lack of personal interview for the families. One of the major accomplishments from the on-going study has been the identification of LPHN3, a key gene involved in the etiology of ADHD and comorbid conditions in one of the previously identified regions of strong genetic signal in chromosome 4q13.2.
PERIOD OF PERFORMANCE:
February 24, 2015 through February 23, 2016
PLACE OF PERFORMANCE:
• Work will primarily be conducted at the Children's National Medical Center, 111 Michigan Avenue, NW, Washington, DC 20010. However, meetings and consultations, maybe held at the NIH Main Government Facility in various NHGRI Buildings as needed.
The Contractor shall provide by the Researcher Child Neurologist from the Department of Neurology at CNMC:
1. The Contractor shall provide Confirmatory evaluation of data collected for the diagnosis of ADHD;
2. The Contractor shall provide revision of clinical records, previous medical history and evaluations done in cases that are otherwise unclear if they represent ADHD cases vs phenocopies;
3. The Contractor shall provide coordination of the clinical research team;
4. The Contractor shall provide participation in analysis and interpretation of data collected as a part of the study;
5. The Contractor shall provide participation and leadership in analysis and publication of scientific papers related to our research;
6. The Contractor shall provide development of collaborations with other institutions, both on a national and international basis, in order to advance our research program;
7. The Contractor shall serve as advisor and provide recommendations to members of the public who contact us as a part of the study requesting orientation for services related with ADHD;
8. The Contractor shall provide preparation and processing of all supporting documents requested by the NHGRI IRB;
9. The Contractor shall provide supervision of the ADHD database and compliance with the IT security requirements;
10. The Contractor shall guarantee the confidentiality of the data collected and compliance of the research team with the safety requirements to manage personal identifiers;
11. The Contractor shall attend scientific meetings whenever necessary to present progress in our studies';
12. The Contractor shall serving as a liaison to patient associations to provide feedback to our research and to encourage their participation in our study;
13. The Contractor shall supervise and coordination of on-going cooperation for our study with the Amish Population in Lancaster Co, PA; and the MTA study group;
14. The Contractor shall communicate with research colleagues in Colombia South America, for analysis and interpretation of collected data; and
15. The Contractor shall provide communication and analysis of any other potential collaboration in genetics of ADHD; to be presented for discussion with the NIH-NHGRI Government Principal Investigators.
1. The Contractor shall be available at NHGRI Government Facility located in Bethesda, Maryland two days a week.
2. The Contractor shall conduct meetings with research staff on a quarterly basis or more frequently as needed.
3. The Contractor shall provide Consultations with individual NHGRI Government research staff as needed regarding particular research study participants.
4. The Contractor shall provide and participate in Scientific publications.
5. The Contractor shall communicate with members of collaboration teams.
6. The Contractor shall support and participate in grant writing for those collaborators applying for external funding for studies that are associated with NHGRI research.
7. The Contractor shall coordinate and attend scientific meetings if necessary.
GOVERNMENT FURNISHED EQUIPMENT:
The Contractor will be provided when on NIH Government Facility a Laptop, office space and computer in the lab, locked File cabinet as needed.
Industry Classification (NAICS) Code is 622110, General Medical and Surgical Hospitals, small business size standard is $38.5M. The acquisition is being conducted under FAR Part 13, simplified acquisition procedures, therefore the requirements of FAR Part 6 B Competitive Requirements are not applicable (FAR Part 6.001). The resultant Contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-78 (November 25, 2014). This requirement is under the SAT of $150,000.00.
This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.
All responses must be received by December 12, 2014 and must reference synopsis number HHS-NIH-NHLBI-CSB-(HG)-2015-036-DLM, may be submitted to the National, Heart, Lung and Blood Institute, Office of Acquisition, Office of Management, COAC Services Branch, 6701 Rockledge Drive, Suite 6149, Bethesda, Maryland 20892-7902, Attention: Dorothy Maxwell. Response may be submitted electronically to firstname.lastname@example.org. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."