National Institute of Mental Health; Notice of Meeting, 57865-57866 [2013-22867]
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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
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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.
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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
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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
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17:24 Sep 19, 2013
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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.
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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
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[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