81 FR 40707 - Request for Information on the Availability of Biological Samples to Evaluate the Technical Performance of Inflammatory Markers

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 120 (June 22, 2016)

The National Institute of Mental Health (NIMH) seeks information about the availability of data and existing biological specimens (plasma and cerebrospinal fluid (CSF)) obtained from healthy controls and clinically well-characterized individuals with mental illnesses (bipolar disorder, major depressive disorder, post-traumatic stress disorder, schizophrenia). This information will be used to identify biobanks of existing samples that could potentially be sourced to assess the technical performance of a panel of inflammation-related proteins, and to identify gaps in the availability of samples for the mental illnesses listed above.

[Federal Register Volume 81, Number 120 (Wednesday, June 22, 2016)]
[Notices]
[Pages 40707-40708]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-14740]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institute of Mental Health


Request for Information on the Availability of Biological Samples 
to Evaluate the Technical Performance of Inflammatory Markers

SUMMARY: The National Institute of Mental Health (NIMH) seeks 
information about the availability of data and existing biological 
specimens (plasma and cerebrospinal fluid (CSF)) obtained from healthy 
controls and clinically well-characterized individuals with mental 
illnesses (bipolar disorder, major depressive disorder, post-traumatic 
stress disorder, schizophrenia). This information will be used to 
identify biobanks of existing samples that could potentially be sourced 
to assess the technical performance of a panel of inflammation-related 
proteins, and to identify gaps in the availability of samples for the 
mental illnesses listed above.

DATES: All responses must be submitted via email to 
[email protected] by August 4, 2016.

ADDRESSES: Please direct all inquiries to: [email protected].

FOR FURTHER INFORMATION CONTACT: Nancy L. Desmond, Ph.D., Division of

[[Page 40708]]

Neuroscience & Basic Behavioral Science, National Institute of Mental 
Health, National Institutes of Health, 6001 Executive Blvd., MSC9645, 
Bethesda, MD 20892-9645, [email protected], 301-443-3107.

SUPPLEMENTARY INFORMATION: Sample collection, processing, and storage 
procedures have the potential to affect assay results for basic 
research, biomarker discovery, biomarker validation, and development of 
validated assays. Variability in these procedures may also decrease 
data rigor, thereby increasing the likelihood of irreproducible data, 
incorrect conclusions, and delays in advancing scientific knowledge.
    Recent genetic studies have provided compelling evidence in support 
of the long-held hypothesis that alterations in immune function are 
associated with the pathophysiology of mental illnesses. Abnormal blood 
levels of cytokines have been reported in schizophrenia, bipolar 
disorder and major depressive illness. However, our understanding of 
the role of immune system markers in mental illnesses has not advanced 
due in part to between-study heterogeneity in immune assay methodology, 
diagnosis criteria, severity of disease, number and age of samples, and 
other potential confounds (e.g., medication, comorbidities) (Goldsmith, 
DR et al., Mol. Psychiatry, 23 February 2016; doi:10.1038/mp.2016.3).
    The creation of an agreed upon, standard panel of pro- and anti-
inflammatory markers, along with adoption of a standard approach for 
sample collection and handling, would be a valuable resource for 
evaluation of inflammatory processes in mental illnesses.
    This request for information (RFI) seeks information from the 
community about the availability, quality, and degree of clinical 
characterization of plasma and CSF samples that could potentially be 
used for assessing the technical performance of a panel of inflammatory 
markers and the utility of the panel for sub-typing individuals and 
tracking disease progression in individuals with mental illness.
    The NIMH seeks information on the following:
    1. Source and number of samples available for each disorder and for 
healthy controls. Include the number of plasma samples and the number 
of CSF samples available, and whether both plasma and CSF samples are 
available from the same individuals.
    2. SOPs used for sample collection and storage
    3. Available clinical data: diagnosis, age of onset and duration of 
illness, demographics, medications, co-morbidities
    4. Consent for sharing of samples
    5. Contact information for the individual responsible for the 
samples
    Respondents are encouraged to include any other information that 
they deem relevant to the purpose of this RFI.
    The NIH will use the information submitted in response to this RFI 
at its discretion and will not provide comments to any responder's 
submission. However, responses to the RFI may be reflected in future 
funding opportunity announcements. The information provided will be 
analyzed and may be aggregated in reports. Respondents are advised that 
the Government is under no obligation to acknowledge receipt of the 
information received or provide feedback to respondents with respect to 
any information submitted. No proprietary, classified, confidential, or 
sensitive information should be included in your response. The 
Government reserves the right to use any non-proprietary technical 
information in any resultant solicitation(s).

    Dated: June 16, 2016.
Shelli Avenevoli,
Acting Deputy Director, National Institute of Mental Health.
[FR Doc. 2016-14740 Filed 6-21-16; 8:45 am]
 BILLING CODE 4140-01-P