Submission for OMB Review; 30-Day Comment Request National Institute of Health Neurobiobank Tissue Access Request, 26930 [2015-11332]

Download as PDF 26930 Federal Register / Vol. 80, No. 90 / Monday, May 11, 2015 / Notices conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by May 20, 2015. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Kristina Toliver at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). 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 VerDate Sep<11>2014 17:00 May 08, 2015 Jkt 235001 PO 00000 Frm 00042 Fmt 4703 Sfmt 9990 E:\FR\FM\11MYN1.SGM 11MYN1

Agencies

[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]


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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
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