National Institute of Mental Health; Notice of Meeting, 57865-57866 [2013-22867]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 183 / Friday, September 20, 2013 / Notices see https://privacyruleandresearch.nih.gov/ pr_08.asp. 9 An Institutional Signing Official is generally a senior official at an institution who is credentialed through the NIH eRA Commons system and is authorized to enter the institution into a legally binding contract and sign on behalf of an investigator who has submitted data or a data access request to the NIH. 10 The NIH’s 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. See https://www.nih.gov/about/ mission.htm. 11 Final NIH Statement on Sharing Research Data. February 26, 2003. See https:// grants.nih.gov/grants/guide/notice-files/ NOT-OD-03-032.html. 12 NIH Intramural Policy on Large Database Sharing. April 5, 2002. See https:// sourcebook.od.nih.gov/ethic-conduct/largedb-sharing.htm. 13 GWAS has the same definition in this policy as in the 2007 GWAS Policy: a study in which the density of genetic markers and the extent of linkage disequilibrium should be sufficient to capture (by the r2 parameter) a large proportion of the common variation in the genome of the population under study, and the number of samples (in a case-control or trio design) should provide sufficient power to detect variants of modest effect. 14 Competing grant applications encompass all activities with a research component, including but not limited to the following: Research Grants (Rs), Program Projects (Ps), Cooperative Research Mechanisms (Us), Career Development Awards (Ks), and SCORs and other S grants with a research component. 15 Investigators should refer to funding announcements or IC Web sites for contact information. 16 NIH Policy on Sharing of Model Organisms for Biomedical Research. Release Date May 7, 2004. See https://grants.nih.gov/ grants/guide/notice-files/NOT-OD-04042.html. 17 Gene Expression Omnibus at https:// www.ncbi.nlm.nih.gov/geo/. 18 Sequence Read Archive at https:// www.ncbi.nlm.nih.gov/Traces/sra/sra.cgi?. 19 Trace Archive at https:// www.ncbi.nlm.nih.gov/Traces/trace.cgi. 20 Array Express at https://www.ebi.ac.uk/ arrayexpress/. 21 Mouse Genome Informatics at https:// www.informatics.jax.org/. 22 WormBase at https://www.wormbase.org. 23 The Zebrafish Model Organism Database at https://zfin.org/. 24 GenBank at https:// www.ncbi.nlm.nih.gov/genbank/. 25 European Nucleotide Archive at https:// www.ebi.ac.uk/ena/. 26 DNA Data Bank of Japan at https:// www.ddbj.nig.ac.jp/. 27 A period for data preparation is anticipated prior to data submission to the NIH, and the appropriate time intervals for that data preparation (or data cleaning) will be subject to the particular data type and project plans (see Appendix A). Investigators VerDate Mar<15>2010 17:24 Sep 19, 2013 Jkt 229001 should work with NIH Program or Project Officials for specific guidance. 28 See 45 CFR 46.102(f) at https:// www.hhs.gov/ohrp/humansubjects/guidance/ 45cfr46.html#46.102. 29 See 45 CFR 164.514(b)(2). The list of HIPAA identifiers that must be removed is available at: https://www.gpo.gov/fdsys/pkg/ CFR-2002-title45-vol1/pdf/CFR-2002-title45vol1-sec164-514.pdf. 30 For additional information about Certificates of Confidentiality, see https:// grants.nih.gov/grants/policy/coc/. 31 Confidentiality Certificate. HG–2009–01. Issued to the National Center for Biotechnology Information, National Library of Medicine, NIH. See https://www.ncbi. nlm.nih.gov/projects/gap/cgi-bin/ GetPdf.cgi?document_name=Confidentiality Certificate.pdf. 32 Database of Genotypes and Phenotypes at https://www.ncbi.nlm.nih.gov/gap. 33 Cancer Genomics Hub at https:// cghub.ucsc.edu/. 34 The 1000 Genomes Project at https:// www.1000genomes.org/. 35 Points to Consider for IRBs and Institutions in their Review of Data Submission Plans for Institutional Certifications. See https://gwas.nih.gov/pdf/ PTC_for_IRBs_and_Institutions_revised5-3111.pdf. 36 Clinical specimens are specimens that have been obtained through clinical practice. 37 For the submission of data derived from cell lines or clinical specimens lacking research consent that were created or collected before the effective date of this Policy, the Institutional Certification needs to address only this item. 38 For guidance on clearly communicating inappropriate data uses, see NIH Points to Consider in Drafting Effective Data Use Limitation Statements, https://gwas.nih.gov/ pdf/NIH_PTC_in_Drafting_DUL_ Statements.pdf. 39 ‘‘Equivalent body’’ is used here to acknowledge that some primary studies may be conducted abroad and in such cases the expectation is that an analogous review committee to an IRB or Privacy Board (e.g., Research Ethics Committees) may be asked to participate in the presubmission review of proposed genomic projects. 40 As noted earlier, for studies using data or specimens collected before the effective date of this Policy, the IRB or Privacy Board should review informed consent materials to ensure that data submission is not inconsistent with the informed consent provided by the research participants. 41 Compilation of Aggregate Genomic Data. dbGaP study accession: phs000501.v1.p1. See https://www.ncbi.nlm.nih.gov/projects/ gap/cgi-bin/study501.cgi?study_ id=phs000501.v1.p1&pha=&phaf=. 42 dbGaP Authorized Access. See https:// dbgap.ncbi.nlm.nih.gov/aa/ wga.cgi?page=login. 43 For a list of NIH Data Access Committees, see https://gwas.nih.gov/04po2_ 1DAC.html. 44 User Code of Conduct. See https:// dbgap.ncbi.nlm.nih.gov/aa/GWAS_Code_of_ Conduct.html. PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 57865 45 Model Data Use Certification Agreement. See https://gwas.nih.gov/pdf/Model_DUC_726-13.pdf. 46 Security Best Practices. See https:// www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/ GetPdf.cgi?document_name=dbgap_2b_ security_procedures.pdf. 47 In Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al. 569 U.S. ___ 2013. See https://www.supremecourt.gov/ opinions/12pdf/12-398_1b7d.pdf. 48 NIH Best Practices for the Licensing of Genomic Inventions. See https://www.ott.nih. gov/policy/genomic_invention.html. 49 Research Tools Policy. See https:// www.ott.nih.gov/policy/research_tool.aspx. Dated: September 16, 2013. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2013–22941 Filed 9–19–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of an Interagency Autism Coordinating Committee (IACC or Committee) meeting. The purpose of the IACC meeting is to discuss committee business, updates and issues related to autism spectrum disorder (ASD) research and services activities. The meeting will be open to the public and will be accessible by webcast and conference call. Name of Committee: Interagency Autism Coordinating Committee (IACC). Type of meeting: Open Meeting. Date: October 9, 2013. Time: 9:00 a.m. to 5:00 p.m.* Eastern Time * Approximate end time. Agenda: To discuss committee business, updates and issues related to ASD research and services activities. Place: Fishers Lane Conference Center, 5635 Fisher Lane, Terrace Level, Rockville, MD 20852, (Parking on site.) Web cast Live: https://videocast.nih.gov/. Conference Call: Dial: 888–989–4620. Access: Access code: 2327818. Cost: The meeting is free and open to the public. Registration: Pre-registration is recommended to expedite check-in. Seating in the meeting room is limited to room capacity and on a first come, first served basis. To register, please visit www.iacc.hhs.gov. Deadlines: Notification of intent to present oral comments: Friday, September 27, 2013 by 5:00 p.m. e.t. Submission of written/electronic statement for oral comments: Wednesday, October 2, 2013 by 5:00 p.m. e.t. E:\FR\FM\20SEN1.SGM 20SEN1 57866 Federal Register / Vol. 78, No. 183 / Friday, September 20, 2013 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES Final Deadline for Submission of written comments: Wednesday, October 2, 2013 by 5:00 p.m. e.t. Please note: The NIMH Office of Autism Research Coordination (OARC) anticipates that written public comments received by the deadline of 5:00 p.m. e.t., Wednesday, October 2, 2013 will be presented to the Committee prior to the October 9th meeting for the Committee’s consideration. Any written comments received after the October 2, 2013 deadline (between October 3, 2013 and October 8, 2013) will be provided to the Committee either before or after the meeting, depending on the volume of comments received and the staff time required to process them in accordance with privacy regulations and other applicable Federal policies. Access: Twinbrook Metro (Red Line). Contact Person: Ms. Lina Perez, Office of Autism Research Coordination, National Institute of Mental Health, NIH, 6001 Executive Boulevard, Room 6182A, Bethesda, MD 20892–9669, Phone: 301–443–6040, Email: IACCPublicInquiries@mail.nih.gov. Public Comments Any member of the public interested in presenting oral comments to the Committee must notify the Contact Person listed on this notice by 5:00 p.m. ET on Friday, September 27, 2013, with their request to present oral comments at the meeting. Interested individuals and representatives of organizations must submit a written/ electronic copy of the oral presentation/ statement including a brief description of the organization represented by 5:00 p.m. E.T. on Wednesday, October 2, 2013. Statements submitted will become a part of the public record. Only one representative of an organization will be allowed to present oral comments and presentations will be limited to three to five minutes per speaker, depending on the number of speakers to be accommodated within the allotted time. Speakers will be assigned a time to speak in the order of the date and time when their request to speak is received, along with the required submission of the written/electronic statement by the specified deadline. In addition, any interested person may submit written comments to the IACC prior to the meeting by sending the comments to the Contact Person listed on this notice by 5:00 p.m. ET on Wednesday, October 2, 2013. The comments should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. NIMH anticipates written public comments received by 5:00 p.m. E.T., Wednesday, October 2, 2013 will be presented to the Committee prior to the meeting for the Committee’s consideration. Any written comments received after the October 2, 2013 deadline (between October 3, 2013 and October 8, 2013) will be provided to the Committee either before or after the meeting, depending on the volume of comments received and the staff time required to process them in accordance with privacy regulations and other applicable Federal policies. All written public comments and oral public comment statements received by the deadlines for both VerDate Mar<15>2010 17:24 Sep 19, 2013 Jkt 229001 oral and written public comments will be provided to the IACC for their consideration and will become part of the public record. Core Values In the 2009 IACC Strategic Plan, the IACC listed the ‘‘Spirit of Collaboration’’ as one of its core values, stating that, ‘‘We will treat others with respect, listen to diverse views with open minds, discuss submitted public comments, and foster discussions where participants can comfortably offer opposing opinions.’’ In keeping with this core value, the IACC and the NIMH Office of Autism Research Coordination (OARC) ask that members of the public who provide public comments or participate in meetings of the IACC also seek to treat others with respect and consideration in their communications and actions, even when discussing issues of genuine concern or disagreement. Remote Access The meeting will be open to the public through a conference call phone number and webcast live on the Internet. Members of the public who participate using the conference call phone number will be able to listen to the meeting but will not be heard. If you experience any technical problems with the web cast or conference call, please send an email to helpdeskiacc@gmail.com or by phone at 415–652–8023. Special Accommodations Individuals who participate in person or by using these electronic services and who need special assistance, such as captioning of the conference call or other reasonable accommodations, should submit a request to the Contact Person listed on this notice at least 5 days prior to the meeting. Security As a part of security procedures, attendees should be prepared to present a photo ID at the meeting registration desk during the check-in process. Pre-registration is recommended. Seating will be limited to the room capacity and seats will be on a first come, first served basis, with expedited check-in for those who are pre-registered. Meeting schedule subject to change. Information about the IACC is available on the Web site: https://www.iacc.hhs.gov. Dated: September 12, 2013. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–22867 Filed 9–19–13; 8:45 am] BILLING CODE 4140–01–P The meetings will be closed to the public in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Sample Biorepository and Laboratory Center for Myeloid Dysplasia Diseases. Date: October 10, 2013. Time: 8:00 a.m. to 12:00 p.m. Agenda: To review and evaluate contract proposals. Place: Doubletree Hotel Bethesda (Formerly Holiday Inn Select), 8120 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Michael P Reilly, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7200, Bethesda, MD 20892, 301–496–9659, reillymp@nhlbi.nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Data Center for Myeloid Dysplasia Diseases. Date: October 10, 2013. Time: 12:30 p.m. to 5:00 p.m. Agenda: To review and evaluate contract proposals. Place: Doubletree Hotel Bethesda (Formerly Holiday Inn Select), 8120 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Michael P Reilly, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7200, Bethesda, MD 20892, 301–496–9659, reillymp@nhlbi.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: September 13, 2013. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–22866 Filed 9–19–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; 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. PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as E:\FR\FM\20SEN1.SGM 20SEN1

Agencies

[Federal Register Volume 78, Number 183 (Friday, September 20, 2013)]
[Notices]
[Pages 57865-57866]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22867]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Mental Health; Notice of Meeting

    Pursuant to section 10(a) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of an Interagency 
Autism Coordinating Committee (IACC or Committee) meeting.
    The purpose of the IACC meeting is to discuss committee business, 
updates and issues related to autism spectrum disorder (ASD) research 
and services activities. The meeting will be open to the public and 
will be accessible by webcast and conference call.

    Name of Committee: Interagency Autism Coordinating Committee 
(IACC).
    Type of meeting: Open Meeting.
    Date: October 9, 2013.
    Time: 9:00 a.m. to 5:00 p.m.* Eastern Time * Approximate end 
time.
    Agenda: To discuss committee business, updates and issues 
related to ASD research and services activities.
    Place: Fishers Lane Conference Center, 5635 Fisher Lane, Terrace 
Level, Rockville, MD 20852, (Parking on site.)
    Web cast Live: https://videocast.nih.gov/.
    Conference Call: Dial: 888-989-4620.
    Access: Access code: 2327818.
    Cost: The meeting is free and open to the public.
    Registration: Pre-registration is recommended to expedite check-
in. Seating in the meeting room is limited to room capacity and on a 
first come, first served basis. To register, please visit 
www.iacc.hhs.gov.
    Deadlines: Notification of intent to present oral comments: 
Friday, September 27, 2013 by 5:00 p.m. e.t.
    Submission of written/electronic statement for oral comments: 
Wednesday, October 2, 2013 by 5:00 p.m. e.t.

[[Page 57866]]

    Final Deadline for Submission of written comments: Wednesday, 
October 2, 2013 by 5:00 p.m. e.t.
    Please note: The NIMH Office of Autism Research Coordination 
(OARC) anticipates that written public comments received by the 
deadline of 5:00 p.m. e.t., Wednesday, October 2, 2013 will be 
presented to the Committee prior to the October 9th meeting for the 
Committee's consideration. Any written comments received after the 
October 2, 2013 deadline (between October 3, 2013 and October 8, 
2013) will be provided to the Committee either before or after the 
meeting, depending on the volume of comments received and the staff 
time required to process them in accordance with privacy regulations 
and other applicable Federal policies.
    Access: Twinbrook Metro (Red Line).
    Contact Person: Ms. Lina Perez, Office of Autism Research 
Coordination, National Institute of Mental Health, NIH, 6001 
Executive Boulevard, Room 6182A, Bethesda, MD 20892-9669, Phone: 
301-443-6040, Email: IACCPublicInquiries@mail.nih.gov.

Public Comments

    Any member of the public interested in presenting oral comments 
to the Committee must notify the Contact Person listed on this 
notice by 5:00 p.m. ET on Friday, September 27, 2013, with their 
request to present oral comments at the meeting. Interested 
individuals and representatives of organizations must submit a 
written/electronic copy of the oral presentation/statement including 
a brief description of the organization represented by 5:00 p.m. 
E.T. on Wednesday, October 2, 2013. Statements submitted will become 
a part of the public record. Only one representative of an 
organization will be allowed to present oral comments and 
presentations will be limited to three to five minutes per speaker, 
depending on the number of speakers to be accommodated within the 
allotted time. Speakers will be assigned a time to speak in the 
order of the date and time when their request to speak is received, 
along with the required submission of the written/electronic 
statement by the specified deadline.
    In addition, any interested person may submit written comments 
to the IACC prior to the meeting by sending the comments to the 
Contact Person listed on this notice by 5:00 p.m. ET on Wednesday, 
October 2, 2013. The comments should include the name, address, 
telephone number and when applicable, the business or professional 
affiliation of the interested person. NIMH anticipates written 
public comments received by 5:00 p.m. E.T., Wednesday, October 2, 
2013 will be presented to the Committee prior to the meeting for the 
Committee's consideration. Any written comments received after the 
October 2, 2013 deadline (between October 3, 2013 and October 8, 
2013) will be provided to the Committee either before or after the 
meeting, depending on the volume of comments received and the staff 
time required to process them in accordance with privacy regulations 
and other applicable Federal policies. All written public comments 
and oral public comment statements received by the deadlines for 
both oral and written public comments will be provided to the IACC 
for their consideration and will become part of the public record.

Core Values

    In the 2009 IACC Strategic Plan, the IACC listed the ``Spirit of 
Collaboration'' as one of its core values, stating that, ``We will 
treat others with respect, listen to diverse views with open minds, 
discuss submitted public comments, and foster discussions where 
participants can comfortably offer opposing opinions.'' In keeping 
with this core value, the IACC and the NIMH Office of Autism 
Research Coordination (OARC) ask that members of the public who 
provide public comments or participate in meetings of the IACC also 
seek to treat others with respect and consideration in their 
communications and actions, even when discussing issues of genuine 
concern or disagreement.

Remote Access

    The meeting will be open to the public through a conference call 
phone number and webcast live on the Internet. Members of the public 
who participate using the conference call phone number will be able 
to listen to the meeting but will not be heard. If you experience 
any technical problems with the web cast or conference call, please 
send an email to helpdeskiacc@gmail.com or by phone at 415-652-8023.

Special Accommodations

    Individuals who participate in person or by using these 
electronic services and who need special assistance, such as 
captioning of the conference call or other reasonable 
accommodations, should submit a request to the Contact Person listed 
on this notice at least 5 days prior to the meeting.

Security

    As a part of security procedures, attendees should be prepared 
to present a photo ID at the meeting registration desk during the 
check-in process. Pre-registration is recommended. Seating will be 
limited to the room capacity and seats will be on a first come, 
first served basis, with expedited check-in for those who are pre-
registered.
    Meeting schedule subject to change.
    Information about the IACC is available on the Web site: https://www.iacc.hhs.gov.


    Dated: September 12, 2013.
Carolyn Baum,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2013-22867 Filed 9-19-13; 8:45 am]
BILLING CODE 4140-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.