21-005820

Submitted by whipple on
Post Date/ Solicitation Issue Date
Closing Response Date
Proposed Award Date
Project Title
Rhythms & Blues Study
Contracting Office
National Institute of Mental Health (NIMH)

Contact Points

Primary Contract Specialist

Cheryl
Leone
cleone@mail.nih.gov
NAICS Code Number
541715
Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
Small Business Size Standard
1000
Estimated Period of Performance
for 1 year after date of award
Delivery of Goods
n/a
Competition Status
Non-Competitive
Vendor Name
Dr. Celine Vetter
Rationale/ Salient Characteristics
A. Specific Requirements:

• Aid in the development of parent and youth feedback on sleep and physical activity from objective actigraphy and EMA;

• Train research coordinators on administration of light devices in the Healthy Brain Network Youth Component of the Rhythms & Blues Study and the Rhythms & Blues Study at the NIH Clinical Center study;

• Aid in EMA adjustments to allow for monitoring of light device procedures and contextualization of continuous light exposure assessment for the Healthy Brain Network Youth Component of the Rhythms & Blues Study and the Rhythms & Blues Study at the NIH Clinical Center study;

• Advise on human melatonin rhythm assessment protocol for the NIH Clinical Center study;

• Aid with integration of novel sleep and circadian biomarker methods into the Rhythms & Blues Study; and
• Implement the plans of light exposure and biomarker data analytic both with the Principal Investigator in the development of publication strategies and priorities and supervise project staff in the exploitation of the light, sleep, and circadian data as part of the Rhythms & Blues as well as the Motor Activity Research Consortium for Health (mMARCH) and manuscript preparation (literature review, peer-review response, general public communication).
Single-Sole Source Determination
This award will include consultation to include gold standard melatonin rhythms assessments that are considered key to understand human circadian physiology. In addition, novel biomarker approaches are now available to identify potential mediators such as circadian phase, and its inclusion in the Rhythms & Blues Study will provide important biological insights into mediators of the physiological effects of light on cognition, behavior, and mood. Successful biomarker implementation will also be an essential proof of principle for scalability of future objective circadian phenotyping in larger-scale studies. Light exposure prior to the Rhythms & Blues Study at the NIH Clinical Center will be assessed with light sensors, also used in the Healthy Brain Network Youth Component, and which have been integrated in the protocols in close consultation with Dr. Vetter. Dr. Vetter will guide research assistants across both study sites with regards to light device set-up, administration, and processing, ensuring quality light exposure assessment. To contextualize environmental light exposure assessments, adaptation of the current Ecological Momentary Assessments (EMAs) is necessary and will be included in this award.

In the context of the longitudinal Healthy Brain Network Youth Component of the Rhythms & Blues Study, participant compliance is of upmost importance. Regular feedback and webinars are one pillar of communication and trust-building efforts of the Rhythms & Blues study team with participants and their parents. Dr. Vetter will provide guidance on feedback layout and content, especially with regards to sleep and physical activity, and will consult and participate in webinars on light, sleep, and circadian rhythms.

Dr. Vetter fits the criteria of a leading authority in this field. Dr. Vetter’s current research focuses on environmental drivers of sleep and circadian disruption and their role for health, including mental health. She is a recognized expert in quantification of circadian disruption and has big-data and epidemiology expertise which is unique for circadian scientists. As part of her work, Dr. Vetter leads observational and interventional investigations into the effects of environmental light patterns using light loggers in gaze direction. Dr. Vetter has received funding by the NIH, CU Boulder, and the Colorado Clinical and Translational Sciences Institute. Her work is also embedded in large-scale epidemiological cohort studies such as the Nurses’ Health Studies, the UK Biobank, and the Hispanic Community Health Study/Study of Latinos.
Background/Description of Requirement
The general purpose is to implement the concepts and procedures from studies in the Division of Intramural Research Programs (IRP) to translate the findings to youth mental health. The major goals of the IRP collaboration would be to advance the primary research goals of our research groups on mood disorders in order to identify links between mood disorders and their underlying dimensional manifestations with objective measures of motor activity and sleep, and mood reactivity and instability and broad outcomes including suicidal behavior, social and educational impairment and onset of emotional and behavior disorders. Data from multiple domains including symptoms, impairment, neuroimaging, reactivity, psychophysiology, motor activity and sleep, cognitive function, and genetics that were collected in the first wave will be used to identify profiles of risk and outcome. The NIMH Family Study is focused on mood disorders and its chief goals are to identify their diagnostic thresholds, subtypes, and boundaries with other disorders in order to identify the genetic and environmental risk factors for these conditions. The major research questions focus on the specificity of familial transmission of the mood disorder spectrum (i.e., symptoms, symptom clusters, subtypes) and the role of comorbidity with anxiety disorders and migraine in defining subtypes of mood disorders. Biologic factors underlying the major components of these disorders are studied in order to identify the core components of these conditions and familial endophenotypes that breed true in families, thereby more closely indexing the expression of underlying genes. Light exposure is a modifiable environmental exposure that has been associated with mental health, cognition, and behavior, mediated in part through its impact on circadian function. This award will include consultation to include gold standard melatonin rhythms assessments that are considered key to understand human circadian physiology. In addition, novel biomarker approaches are now available to identify potential mediators such as circadian phase, and its inclusion in the Rhythms & Blues Study will provide important biological insights into mediators of the physiological effects of light on cognition, behavior, and mood. Successful biomarker implementation will also be an essential proof of principle for scalability of future objective circadian phenotyping in larger-scale studies.

Interested parties may identify in writing their interest and capability in response to this requirement. 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.

All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.

All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.