Request for Information on the Availability of Biological Samples to Evaluate the Technical Performance of Inflammatory Markers, 40707-40708 [2016-14740]

Download as PDF mstockstill on DSK3G9T082PROD with NOTICES Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Notices Time: 10:00 a.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. Contact Person: Ross D Shonat, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6196, MSC 7804, Bethesda, MD 20892, 301–435– 2786, ross.shonat@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Eukaryotic Parasites and Vectors. Date: July 20–21, 2016. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Fouad A El-Zaatari, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3206, MSC 7808, Bethesda, MD 20892, (301) 435– 1149, elzaataf@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Program Project: PAR–14–021: Comprehensive Biology: Exploiting the Yeast Genome. Date: July 20–22, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hotel Deca Seattle, 4507 Brooklyn Avenue NE., Seattle, WA 28105. Contact Person: David Balasundaram, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5189, MSC 7840, Bethesda, MD 20892, 301–435– 1022, balasundaramd@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; US.-China Program for Collaborative Biomedical Research. Date: July 20–21, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Contact Person: Marci Scidmore, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3192, MSC 7808, Bethesda, MD 20892, 301–435– 1149, marci.scidmore@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Biological Chemistry and Macromolecular Biophysics. Date: July 20–21, 2016. Time: 9:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Sudha Veeraraghavan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, 301–435–1504, sudha.veeraraghavan@nih.gov. VerDate Sep<11>2014 20:02 Jun 21, 2016 Jkt 238001 Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Cellular and Physiological Mechanism of Diabetes and Obesity. Date: July 20, 2016. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Hui Chen, MD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, 301–435–1044, chenhui@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: June 15, 2016. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–14690 Filed 6–21–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Neurological, Aging and Musculoskeletal Epidemiology (NAME). Date: June 27–28, 2016. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Heidi B. Friedman, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1012A, MSC 7770, Bethesda, MD 20892, 301–379– 5632, hfriedman@csr.nih.gov. Frm 00055 Fmt 4703 Sfmt 4703 This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Neurological, Aging, and Musculoskeletal Epidemiological Study Section: R03 and R21 Applications. Date: July 15, 2016. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Kate Fothergill, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3142, Bethesda, MD 20892, 301–435–2309, fothergillke@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: June 15, 2016. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–14691 Filed 6–21–16; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health PO 00000 40707 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 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, posttraumatic 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 inflammationrelated 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 biospecimens2@ mail.nih.gov by August 4, 2016. ADDRESSES: Please direct all inquiries to: biospecimens2@mail.nih.gov. FOR FURTHER INFORMATION CONTACT: Nancy L. Desmond, Ph.D., Division of SUMMARY: E:\FR\FM\22JNN1.SGM 22JNN1 40708 Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Notices Neuroscience & Basic Behavioral Science, National Institute of Mental Health, National Institutes of Health, 6001 Executive Blvd., MSC9645, Bethesda, MD 20892–9645, biospecimens2@mail.nih.gov, 301–443– 3107. 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 antiinflammatory 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 mstockstill on DSK3G9T082PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 20:02 Jun 21, 2016 Jkt 238001 3. Available clinical data: diagnosis, age of onset and duration of illness, demographics, medications, comorbidities 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 Date: July 14, 2016. Time: 10:00 a.m. to 12:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Hiromi Ono, Ph.D., Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, National Institutes of Health, DHHS, 6001 Executive Boulevard, Room 4238, MSC 9550, Bethesda, MD 20892, 301– 402–6020, hiromi.ono@nih.gov. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel Summer Research Education Experience Programs (R25). Date: July 19, 2016. Time: 1:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Susan O. McGuire, Ph.D., Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, National Institutes of Health, DHHS, 6001 Executive Blvd., Room 4245, Rockville, MD 20852, 301–435–1426, mcguireso@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) Dated: June 17, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–14777 Filed 6–21–16; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4140–01–P National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute on Drug Abuse; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel Mechanism for Time-Sensitive Drug Abuse Research (R21). PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 National Institutes of Health Submission for OMB Review; 30-Day Comment Request; NLM PEOPLE LOCATOR® System Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on April 15, 2016, page 22289 and allowed 60 days for public comment. There were no comments received. The purpose of this notice is to allow an additional 30 days for public comment. The National Library of Medicine (NLM), National Institutes of Health, may not conduct or SUMMARY: E:\FR\FM\22JNN1.SGM 22JNN1

Agencies

[Federal Register Volume 81, Number 120 (Wednesday, June 22, 2016)]
[Notices]
[Pages 40707-40708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14740]


-----------------------------------------------------------------------

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 
biospecimens2@mail.nih.gov by August 4, 2016.

ADDRESSES: Please direct all inquiries to: biospecimens2@mail.nih.gov.

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, biospecimens2@mail.nih.gov, 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
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