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)

Page Range		40707-40708
FR Document		2016-14740

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 Issue 120 (Wednesday, June 22, 2016)

[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

Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Notices 40707

Time: 10:00 a.m. to 1:00 p.m. Name of Committee: Center for Scientific This notice is being published less than 15
Agenda: To review and evaluate grant Review Special Emphasis Panel; Member days prior to the meeting due to the timing
applications. Conflict: Cellular and Physiological limitations imposed by the review and
Place: National Institutes of Health, 6701 Mechanism of Diabetes and Obesity. funding cycle.
Rockledge Drive, Bethesda, MD 20892. Date: July 20, 2016. Name of Committee: Center for Scientific
Contact Person: Ross D Shonat, Ph.D., Time: 1:00 p.m. to 4:00 p.m. Review Special Emphasis Panel;
Scientific Review Officer, Center for Agenda: To review and evaluate grant Neurological, Aging, and Musculoskeletal
Scientific Review, National Institutes of applications. Epidemiological Study Section: R03 and R21
Health, 6701 Rockledge Drive, Room 6196, Place: National Institutes of Health, 6701 Applications.
MSC 7804, Bethesda, MD 20892, 301–435– Rockledge Drive, Bethesda, MD 20892 Date: July 15, 2016.
2786, ross.shonat@nih.gov. (Virtual Meeting). Time: 10:00 a.m. to 5:00 p.m.
Name of Committee: Center for Scientific Contact Person: Hui Chen, MD, Scientific Agenda: To review and evaluate grant
Review Special Emphasis Panel; Member Review Officer, Center for Scientific Review, applications.
Conflict: Eukaryotic Parasites and Vectors. National Institutes of Health, 6701 Rockledge Place: National Institutes of Health, 6701
Date: July 20–21, 2016. Drive, Bethesda, MD 20892, 301–435–1044, Rockledge Drive, Bethesda, MD 20892
Time: 8:00 a.m. to 6:00 p.m. chenhui@csr.nih.gov. (Virtual Meeting).
Agenda: To review and evaluate grant (Catalogue of Federal Domestic Assistance Contact Person: Kate Fothergill, Ph.D.,
applications. Program Nos. 93.306, Comparative Medicine; Scientific Review Officer, Center for
Place: National Institutes of Health, 6701 93.333, Clinical Research, 93.306, 93.333, Scientific Review, National Institutes of
Rockledge Drive, Bethesda, MD 20892 93.337, 93.393–93.396, 93.837–93.844, Health, 6701 Rockledge Drive, Room 3142,
(Virtual Meeting). 93.846–93.878, 93.892, 93.893, National Bethesda, MD 20892, 301–435–2309,
Contact Person: Fouad A El-Zaatari, Ph.D., Institutes of Health, HHS) fothergillke@mail.nih.gov.
Scientific Review Officer, Center for
(Catalogue of Federal Domestic Assistance
Scientific Review, National Institutes of Dated: June 15, 2016.
Program Nos. 93.306, Comparative Medicine;
Health, 6701 Rockledge Drive, Room 3206, David Clary, 93.333, Clinical Research, 93.306, 93.333,
MSC 7808, Bethesda, MD 20892, (301) 435– Program Analyst, Office of Federal Advisory 93.337, 93.393–93.396, 93.837–93.844,
1149, elzaataf@csr.nih.gov. Committee Policy. 93.846–93.878, 93.892, 93.893, National
Name of Committee: Center for Scientific Institutes of Health, HHS)
[FR Doc. 2016–14690 Filed 6–21–16; 8:45 am]
Review Special Emphasis Panel; Program
Project: PAR–14–021: Comprehensive BILLING CODE 4140–01–P Dated: June 15, 2016.
Biology: Exploiting the Yeast Genome. David Clary,
Date: July 20–22, 2016. Program Analyst, Office of Federal Advisory
Time: 8:00 a.m. to 5:00 p.m. DEPARTMENT OF HEALTH AND Committee Policy.
Agenda: To review and evaluate grant HUMAN SERVICES [FR Doc. 2016–14691 Filed 6–21–16; 8:45 am]
applications.
BILLING CODE 4140–01–P
Place: Hotel Deca Seattle, 4507 Brooklyn National Institutes of Health
Avenue NE., Seattle, WA 28105.
Contact Person: David Balasundaram, Center for Scientific Review; Notice of
Ph.D., Scientific Review Officer, Center for Closed Meetings DEPARTMENT OF HEALTH AND
Scientific Review, National Institutes of HUMAN SERVICES
Health, 6701 Rockledge Drive, Room 5189, Pursuant to section 10(d) of the
MSC 7840, Bethesda, MD 20892, 301–435– Federal Advisory Committee Act, as National Institute of Mental Health
1022, balasundaramd@csr.nih.gov. amended (5 U.S.C. App.), notice is
Name of Committee: Center for Scientific hereby given of the following meetings. Request for Information on the
Review Special Emphasis Panel; US.-China The meetings will be closed to the Availability of Biological Samples to
Program for Collaborative Biomedical public in accordance with the Evaluate the Technical Performance of
Research. provisions set forth in sections Inflammatory Markers
Date: July 20–21, 2016.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., SUMMARY: The National Institute of
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant as amended. The grant applications and Mental Health (NIMH) seeks
applications. the discussions could disclose information about the availability of
Place: Bethesda Marriott Suites, 6711 confidential trade secrets or commercial data and existing biological specimens
Democracy Boulevard, Bethesda, MD 20817. property such as patentable material, (plasma and cerebrospinal fluid (CSF))
Contact Person: Marci Scidmore, Ph.D., and personal information concerning obtained from healthy controls and
Scientific Review Officer, Center for individuals associated with the grant
Scientific Review, National Institutes of clinically well-characterized individuals
applications, the disclosure of which with mental illnesses (bipolar disorder,
Health, 6701 Rockledge Drive, Room 3192,
would constitute a clearly unwarranted major depressive disorder, post-
MSC 7808, Bethesda, MD 20892, 301–435–
1149, marci.scidmore@nih.gov. invasion of personal privacy. traumatic stress disorder,
Name of Committee: Center for Scientific Name of Committee: Center for Scientific schizophrenia). This information will be
Review Special Emphasis Panel; Member Review Special Emphasis Panel; used to identify biobanks of existing
Conflict: Biological Chemistry and Neurological, Aging and Musculoskeletal samples that could potentially be
Macromolecular Biophysics. Epidemiology (NAME). sourced to assess the technical
Date: July 20–21, 2016. Date: June 27–28, 2016.
performance of a panel of inflammation-
Time: 9:00 a.m. to 2:00 p.m. Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant Agenda: To review and evaluate grant related proteins, and to identify gaps in
applications. applications. the availability of samples for the
Place: National Institutes of Health, 6701 Place: National Institutes of Health, 6701 mental illnesses listed above.
mstockstill on DSK3G9T082PROD with NOTICES

Rockledge Drive, Bethesda, MD 20892 Rockledge Drive, Bethesda, MD 20892 DATES: All responses must be submitted
(Virtual Meeting). (Virtual Meeting). via email to biospecimens2@
Contact Person: Sudha Veeraraghavan, Contact Person: Heidi B. Friedman, Ph.D., mail.nih.gov by August 4, 2016.
Ph.D., Scientific Review Officer, Center for Scientific Review Officer, Center for
ADDRESSES: Please direct all inquiries
Scientific Review, National Institutes of Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD Health, 6701 Rockledge Drive, Room 1012A, to: biospecimens2@mail.nih.gov.
20892, 301–435–1504, MSC 7770, Bethesda, MD 20892, 301–379– FOR FURTHER INFORMATION CONTACT:
sudha.veeraraghavan@nih.gov. 5632, hfriedman@csr.nih.gov. Nancy L. Desmond, Ph.D., Division of

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40708 Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Notices

Neuroscience & Basic Behavioral 3. Available clinical data: diagnosis, Date: July 14, 2016.
Science, National Institute of Mental age of onset and duration of illness, Time: 10:00 a.m. to 12:00 p.m.
Health, National Institutes of Health, demographics, medications, co- Agenda: To review and evaluate grant
6001 Executive Blvd., MSC9645, morbidities applications.
Place: National Institutes of Health,
Bethesda, MD 20892–9645, 4. Consent for sharing of samples
Neuroscience Center, 6001 Executive
biospecimens2@mail.nih.gov, 301–443– 5. Contact information for the
Boulevard, Rockville, MD 20852, (Telephone
3107. individual responsible for the samples Conference Call).
Respondents are encouraged to Contact Person: Hiromi Ono, Ph.D.,
SUPPLEMENTARY INFORMATION: Sample include any other information that they
collection, processing, and storage Scientific Review Officer, Office of
deem relevant to the purpose of this Extramural Affairs, National Institute on
procedures have the potential to affect RFI. Drug Abuse, National Institutes of Health,
assay results for basic research, The NIH will use the information DHHS, 6001 Executive Boulevard, Room
biomarker discovery, biomarker submitted in response to this RFI at its 4238, MSC 9550, Bethesda, MD 20892, 301–
validation, and development of discretion and will not provide 402–6020, hiromi.ono@nih.gov.
validated assays. Variability in these comments to any responder’s Name of Committee: National Institute on
procedures may also decrease data rigor, submission. However, responses to the Drug Abuse Special Emphasis Panel Summer
thereby increasing the likelihood of RFI may be reflected in future funding Research Education Experience Programs
irreproducible data, incorrect opportunity announcements. The (R25).
conclusions, and delays in advancing Date: July 19, 2016.
information provided will be analyzed Time: 1:00 p.m. to 3:00 p.m.
scientific knowledge. and may be aggregated in reports.
Recent genetic studies have provided Agenda: To review and evaluate grant
Respondents are advised that the applications.
compelling evidence in support of the Government is under no obligation to Place: National Institutes of Health,
long-held hypothesis that alterations in acknowledge receipt of the information Neuroscience Center, 6001 Executive
immune function are associated with received or provide feedback to Boulevard, Rockville, MD 20852, (Telephone
the pathophysiology of mental illnesses. respondents with respect to any Conference Call).
Abnormal blood levels of cytokines information submitted. No proprietary, Contact Person: Susan O. McGuire, Ph.D.,
have been reported in schizophrenia, classified, confidential, or sensitive Scientific Review Officer, Office of
bipolar disorder and major depressive Extramural Affairs, National Institute on
information should be included in your Drug Abuse, National Institutes of Health,
illness. However, our understanding of response. The Government reserves the
the role of immune system markers in DHHS, 6001 Executive Blvd., Room 4245,
right to use any non-proprietary Rockville, MD 20852, 301–435–1426,
mental illnesses has not advanced due technical information in any resultant mcguireso@mail.nih.gov.
in part to between-study heterogeneity solicitation(s). (Catalogue of Federal Domestic Assistance
in immune assay methodology,
Dated: June 16, 2016. Program Nos.: 93.279, Drug Abuse and
diagnosis criteria, severity of disease, Addiction Research Programs, National
number and age of samples, and other Shelli Avenevoli,
Institutes of Health, HHS)
potential confounds (e.g., medication, Acting Deputy Director, National Institute of
Mental Health. Dated: June 17, 2016.
comorbidities) (Goldsmith, DR et al.,
Mol. Psychiatry, 23 February 2016; [FR Doc. 2016–14740 Filed 6–21–16; 8:45 am] Natasha M. Copeland,
doi:10.1038/mp.2016.3). BILLING CODE 4140–01–P Program Analyst, Office of Federal Advisory
The creation of an agreed upon, Committee Policy.
standard panel of pro- and anti- [FR Doc. 2016–14777 Filed 6–21–16; 8:45 am]
inflammatory markers, along with DEPARTMENT OF HEALTH AND BILLING CODE 4140–01–P
adoption of a standard approach for HUMAN SERVICES
sample collection and handling, would
be a valuable resource for evaluation of National Institutes of Health DEPARTMENT OF HEALTH AND
inflammatory processes in mental HUMAN SERVICES
National Institute on Drug Abuse;
illnesses. Notice of Closed Meetings
This request for information (RFI) National Institutes of Health
seeks information from the community Pursuant to section 10(d) of the Submission for OMB Review; 30-Day
about the availability, quality, and Federal Advisory Committee Act, as Comment Request; NLM PEOPLE
degree of clinical characterization of amended (5 U.S.C. App), notice is LOCATOR® System
plasma and CSF samples that could hereby given of the following meetings.
potentially be used for assessing the The meetings will be closed to the SUMMARY: Under the provisions of
technical performance of a panel of public in accordance with the Section 3507(a)(1)(D) of the Paperwork
inflammatory markers and the utility of provisions set forth in sections Reduction Act of 1995, the National
the panel for sub-typing individuals and 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Institutes of Health (NIH) has submitted
tracking disease progression in as amended. The grant applications and to the Office of Management and Budget
individuals with mental illness. the discussions could disclose (OMB) a request for review and
The NIMH seeks information on the confidential trade secrets or commercial approval of the information collection
following: property such as patentable material, listed below. This proposed information
1. Source and number of samples and personal information concerning collection was previously published in
available for each disorder and for individuals associated with the grant the Federal Register on April 15, 2016,
mstockstill on DSK3G9T082PROD with NOTICES

healthy controls. Include the number of applications, the disclosure of which page 22289 and allowed 60 days for
plasma samples and the number of CSF would constitute a clearly unwarranted public comment. There were no
samples available, and whether both invasion of personal privacy. comments received. The purpose of this
plasma and CSF samples are available Name of Committee: National Institute on notice is to allow an additional 30 days
from the same individuals. Drug Abuse Special Emphasis Panel for public comment. The National
2. SOPs used for sample collection Mechanism for Time-Sensitive Drug Abuse Library of Medicine (NLM), National
and storage Research (R21). Institutes of Health, may not conduct or

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Document Created: 2016-06-22 01:05:47
Document Modified: 2016-06-22 01:05:47

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		All responses must be submitted via email to [email protected] by August 4, 2016.
Contact		Nancy L. Desmond, Ph.D., Division of 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.
FR Citation		81 FR 40707