80 FR 26930 - Submission for OMB Review; 30-Day Comment Request National Institute of Health Neurobiobank Tissue Access Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 90 (May 11, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 90 (May 11, 2015)
| Page Range | 26930-26930 | |
| FR Document | 2015-11332 |
[Federal Register Volume 80, Number 90 (Monday, May 11, 2015)] [Notices] [Page 26930] From the Federal Register Online [www.thefederalregister.org] [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, [email protected] 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: [email protected]. 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
![26930 Federal Register / Vol. 80, No. 90 / Monday, May 11, 2015 / Notices
conduct a lottery to determine the Institutes of Health (NIH) has submitted instruments must be requested in
speakers for the scheduled open public to the Office of Management and Budget writing.
hearing session. The contact person will (OMB) a request for review and Proposed Collection: National
notify interested persons regarding their approval of the information collection Institute of Health Neurobiobank Tissue
request to speak by May 20, 2015. listed below. This proposed information Access Request—Existing without OMB
Persons attending FDA’s advisory collection was previously published in Clearance—National Institute of Mental
committee meetings are advised that the the Federal Register on February 13, Health (NIMH), National Institute of
Agency is not responsible for providing 2015, page 8723 and allowed 60-days Health (NIH).
access to electrical outlets. for public comment. No public
FDA welcomes the attendance of the comments were received. The purpose Need and Use of Information
public at its advisory committee of this notice is to allow an additional Collection: NIMH is seeking OMB
meetings and will make every effort to 30 days for public comment. The approval for two Neurobiobank data
accommodate persons with physical National Institute of Mental Health collections: (1) Pre-Mortem Donor
disabilities or special needs. If you (NIMH), National Institutes of Health, Recruitment Form, and (2) Tissue
require special accommodations due to may not conduct or sponsor, and the Access Request Form. The pre-mortem
a disability, please contact Kristina respondent is not required to respond donor form will collect information
Toliver at least 7 days in advance of the to, an information collection that has from potential donors to ensure and
meeting. been extended, revised, or implemented enable appropriate research use of the
FDA is committed to the orderly on or after October 1, 1995, unless it tissues and biospecimens. Knowledge
conduct of its advisory committee displays a currently valid OMB control about the health history surrounding a
meetings. Please visit our Web site at number. particular tissue or biospecimen is
http://www.fda.gov/ Direct Comments To OMB: Written essential to ethical scientific research
AdvisoryCommittees/ comments and/or suggestions regarding conducted upon it. The tissue access
AboutAdvisoryCommittees/ the item(s) contained in this notice, request form will collect information
ucm111462.htm for procedures on especially regarding the estimated from researchers who wish to gain
public conduct during advisory public burden and associated response access to the tissue stored throughout
committee meetings. time, should be directed to the: Office the Neurobiobank network, The NIH
Notice of this meeting is given under of Management and Budget, Office of Neurobiobank Tissue Access Request
the Federal Advisory Committee Act (5 Regulatory Affairs, OIRA_submission@ form is necessary to verify that the
U.S.C. app. 2). omb.eop.gov or by fax to 202–395–6974, researcher ‘‘Recipient’’ Principal
Dated: May 5, 2015. Attention: NIH Desk Officer. Investigators and their organization or
Jill Hartzler Warner, Comment Due Date: Comments corporations applying to use the tissue
Associate Commissioner for Special Medical regarding this information collection are is qualified to conduct human tissue
Programs. best assured of having their full effect if research and have approved assurance
[FR Doc. 2015–11257 Filed 5–8–15; 8:45 am] received within 30-days of the date of from the DHHS Office of Human
BILLING CODE 4164–01–P this publication. Research Protections to access tissue or
FOR FURTHER INFORMATION CONTACT: To biospecimens from the National
obtain a copy of the data collection Neurobiobank for research purposes.
DEPARTMENT OF HEALTH AND plans and instruments or request more The primary use of this information is
HUMAN SERVICES information on the proposed project to document, track, monitor, and
contact: NIMH Project Clearance evaluate the appropriate use of the
National Institutes of Health Liaison, Science Policy and Evaluation Neurobiobank tissue and biospecimen
Branch, OSPPC, NIMH, NIH, resources, as well as to notify interested
Submission for OMB Review; 30-Day recipients of updates, corrections, or
Neuroscience Center, 6001 Executive
Comment Request National Institute of other changes to the system.
Boulevard, MSC 9667, Rockville Pike,
Health Neurobiobank Tissue Access
Bethesda, MD 20892, or call 301–443– OMB approval is requested for 3
Request
4335 or Email your request, including years. There are no costs to respondents
SUMMARY: Under the provisions of your address to: other than their time. The total
Section 3507(a)(1)(D) of the Paperwork nimhprapubliccomments@mail.nih.gov. estimated annualized burden hours are
Reduction Act of 1995, the National Formal requests for additional plans and 38.
ESTIMATED ANNUALIZED BURDEN HOURS
Average Total annual
Number of Frequency burden per
Form burden
respondents of response response hours
(in hours)
Neurobiobank Tissue Access Request ........................................................................... 50 1 30/60 25
Pre-Mortem Donor Recruitment Form ............................................................................. 50 1 15/60 13
Total .......................................................................................................................... 100 .................... .................... 38
tkelley on DSK3SPTVN1PROD with NOTICES
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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Document Created: 2018-02-21 10:26:17
Document Modified: 2018-02-21 10:26:17
| 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 | Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. | |
| 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, | |
| FR Citation | 80 FR 26930 |
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