View Information Collection Request (ICR) Package

OMB Control No: 0925-0723	ICR Reference No: 202409-0925-004
Status: Active	Previous ICR Reference No: 202109-0925-003
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: The National Institutes of Health (NIH) NeuroBioBank Tissue Access Request and Progress Report Forms
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/08/2024
	Date Received in OIRA: 09/24/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2027	36 Months From Approved	11/30/2024
Responses	700	0	400
Time Burden (Hours)	175	0	100
Cost Burden (Dollars)	0	0	0

Abstract: This application for the National Institutes of Health (NIH) NeuroBioBank Tissue Access Request Form and Progress Report Form is a revision to the Neurobiobank Tissue Access Request (NBB) application, which OMB approved in 2021. When unraveling the complexities of neurological, neurodevelopmental, and neuropsychiatric disorders, there is no substitute for studying human brain tissue. Brain donation is critically important, now more than ever. The more brain tissue available for research, the faster science can advance toward a better understanding of how to prevent, diagnose, treat, and cure disorders of the human brain. In order to meet this need, three NIH institutes came together to build a network of biorepositories to collect and distribute brain tissue to investigators across the country for research on a variety of brain disorders. With support from the National Institute of Mental Health (NIMH), the National Institute of Neurological Disorders and Stroke (NINDS), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the NBB was launched in 2013. The major goals of the NBB are to enhance the distribution of high-quality, well-characterized human post-mortem brain tissue to investigators and to increase awareness of the value of brain donation among the public. Due to its success in achieving this mission, the National Institute on Aging and the NIH Blueprint for Neuroscience Research, have also joined the NBB network. The NBB provides access to the tissue collections of six contracted sites, as well as additional resources to facilitate research studies, including donor medical records and clinical data sets (when available) and tissue quality metrics.

Authorizing Statute(s): US Code: 42 USC sections 232,281 and 285g Name of Law: Public Health Service Act

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 57915	07/16/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 77534	09/23/2024
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	700	400	300
Annual Time Burden (Hours)	175	100	75
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Changing Forms

Short Statement: There have been changes to the information collected by the NBB Tissue Access Request Form (Attachments 1-5), and the addition of the NBB Progress Report Form. Based upon the addition of the NBB Progress Report Form, NIMH has updated the total annual burden hours for respondents to 175 (from 100). NIMH estimates the NBB Tissue Access Request Form and the NBB Progress Report Form will each take 15 minutes to complete.

Annual Cost to Federal Government: $66,824

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

Agency Contact: Mikia Currie 3014350941

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