Submission for OMB Review; 30-Day Comment Request National Institute of Health Neurobiobank Tissue Access Request, 26930 [2015-11332]
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Federal Register / Vol. 80, No. 90 / Monday, May 11, 2015 / Notices
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Dated: May 5, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–11257 Filed 5–8–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request National Institute of
Health Neurobiobank Tissue Access
Request
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
SUMMARY:
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 February 13,
2015, page 8723 and allowed 60-days
for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Institute of Mental Health
(NIMH), National Institutes of Health,
may not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
Direct Comments To OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: NIMH Project Clearance
Liaison, Science Policy and Evaluation
Branch, OSPPC, NIMH, NIH,
Neuroscience Center, 6001 Executive
Boulevard, MSC 9667, Rockville Pike,
Bethesda, MD 20892, or call 301–443–
4335 or Email your request, including
your address to:
nimhprapubliccomments@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: National
Institute of Health Neurobiobank Tissue
Access Request—Existing without OMB
Clearance—National Institute of Mental
Health (NIMH), National Institute of
Health (NIH).
Need and Use of Information
Collection: NIMH is seeking OMB
approval for two Neurobiobank data
collections: (1) Pre-Mortem Donor
Recruitment Form, and (2) Tissue
Access Request Form. The pre-mortem
donor form will collect information
from potential donors to ensure and
enable appropriate research use of the
tissues and biospecimens. Knowledge
about the health history surrounding a
particular tissue or biospecimen is
essential to ethical scientific research
conducted upon it. The tissue access
request form will collect information
from researchers who wish to gain
access to the tissue stored throughout
the Neurobiobank network, The NIH
Neurobiobank Tissue Access Request
form is necessary to verify that the
researcher ‘‘Recipient’’ Principal
Investigators and their organization or
corporations applying to use the tissue
is qualified to conduct human tissue
research and have approved assurance
from the DHHS Office of Human
Research Protections to access tissue or
biospecimens from the National
Neurobiobank for research purposes.
The primary use of this information is
to document, track, monitor, and
evaluate the appropriate use of the
Neurobiobank tissue and biospecimen
resources, as well as to notify interested
recipients of updates, corrections, or
other changes to the system.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
38.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Frequency
of response
Average
burden per
response
(in hours)
Total annual
burden
hours
Neurobiobank Tissue Access Request ...........................................................................
Pre-Mortem Donor Recruitment Form .............................................................................
50
50
1
1
30/60
15/60
25
13
Total ..........................................................................................................................
100
....................
....................
38
tkelley on DSK3SPTVN1PROD with NOTICES
Form
Dated: May 5, 2015.
Keisha L. Shropshire,
NIMH Project Clearance Officer, NIMH, NIH.
[FR Doc. 2015–11332 Filed 5–8–15; 8:45 am]
BILLING CODE 4140–01–P
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[Federal Register Volume 80, Number 90 (Monday, May 11, 2015)]
[Notices]
[Page 26930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11332]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request National
Institute of Health Neurobiobank Tissue Access Request
SUMMARY: 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 February 13, 2015, page 8723 and allowed 60-days for public
comment. No public comments were received. The purpose of this notice
is to allow an additional 30 days for public comment. The National
Institute of Mental Health (NIMH), National Institutes of Health, may
not conduct or sponsor, and the respondent is not required to respond
to, an information collection that has been extended, revised, or
implemented on or after October 1, 1995, unless it displays a currently
valid OMB control number.
Direct Comments To OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments or request more information on the
proposed project contact: NIMH Project Clearance Liaison, Science
Policy and Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center,
6001 Executive Boulevard, MSC 9667, Rockville Pike, Bethesda, MD 20892,
or call 301-443-4335 or Email your request, including your address to:
nimhprapubliccomments@mail.nih.gov. Formal requests for additional
plans and instruments must be requested in writing.
Proposed Collection: National Institute of Health Neurobiobank
Tissue Access Request--Existing without OMB Clearance--National
Institute of Mental Health (NIMH), National Institute of Health (NIH).
Need and Use of Information Collection: NIMH is seeking OMB
approval for two Neurobiobank data collections: (1) Pre-Mortem Donor
Recruitment Form, and (2) Tissue Access Request Form. The pre-mortem
donor form will collect information from potential donors to ensure and
enable appropriate research use of the tissues and biospecimens.
Knowledge about the health history surrounding a particular tissue or
biospecimen is essential to ethical scientific research conducted upon
it. The tissue access request form will collect information from
researchers who wish to gain access to the tissue stored throughout the
Neurobiobank network, The NIH Neurobiobank Tissue Access Request form
is necessary to verify that the researcher ``Recipient'' Principal
Investigators and their organization or corporations applying to use
the tissue is qualified to conduct human tissue research and have
approved assurance from the DHHS Office of Human Research Protections
to access tissue or biospecimens from the National Neurobiobank for
research purposes. The primary use of this information is to document,
track, monitor, and evaluate the appropriate use of the Neurobiobank
tissue and biospecimen resources, as well as to notify interested
recipients of updates, corrections, or other changes to the system.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 38.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average Total
Number of Frequency burden per annual
Form respondents of response response burden
(in hours) hours
----------------------------------------------------------------------------------------------------------------
Neurobiobank Tissue Access Request.......................... 50 1 30/60 25
Pre-Mortem Donor Recruitment Form........................... 50 1 15/60 13
---------------------------------------------------
Total................................................... 100 ........... ........... 38
----------------------------------------------------------------------------------------------------------------
Dated: May 5, 2015.
Keisha L. Shropshire,
NIMH Project Clearance Officer, NIMH, NIH.
[FR Doc. 2015-11332 Filed 5-8-15; 8:45 am]
BILLING CODE 4140-01-P
