The National Institutes of Health (NIH) NeuroBioBank Tissue Access Request and Progress Report Forms

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 1 Progress Report	Form	Unchanged	Available
Form 1 Access Request	Form	Unchanged	Available
Form 1 Access Request	Form	Unchanged	Available
Form 1 Access Request	Form	Unchanged	Available
Form 1 Access Request	Form	Unchanged	Available
Form 1 Access Request	Form	Unchanged	Available
Form 1 Access Request	Form	Modified	Available
Att 1_NBB Tissue Access Request_NIH_090326 comment bubbles of changes.pdf	Supplementary Document	Uploaded 2026-09-15	Available
Non-Substantive Change Request Memo_NIMH NBB Tissue Access Request and Progress Report.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2026-09-15	Available
Att 7_NBB Tissue Request Guidance.pdf	Supplementary Document	Uploaded 2024-09-23	Available
Att 9_ IMS Neurobiobank HHS IT Systems PIA.pdf	Supplementary Document	Uploaded 2024-09-23	Available
SSA_NBB Tissue Access Request Form_OMB 0925-0723.docx	Supporting Statement A	Uploaded 2024-09-23	Available
NIMH 30day notice.pdf	Supplementary Document	Uploaded 2024-09-23	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
270956	NBB Progress Report	Form	Unchanged	Progress Report
270955	NBB Tissue Access Request Form (Other Entity-Funded Research)	Form	Unchanged	Access Request
270954	NBB Tissue Access Request Form (Private Industry/Commercial-Funded Research)	Form	Unchanged	Access Request
270953	NBB Tissue Access Request Form (Foreign Government-Funded Research)	Form	Unchanged	Access Request
270952	NBB Tissue Access Request Form (State Government-Funded Research)	Form	Unchanged	Access Request
270951	NBB Tissue Access Request Form (Other US Federal Government-Funded Research)	Form	Unchanged	Access Request
231996	NBB Tissue Access Request Form (NIH-Funded Research)	Form	Modified	Access Request

ICR Details

OMB Control No: 0925-0723	ICR Reference No: 202609-0925-003
Status: Active	Previous ICR Reference No: 202409-0925-004
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: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/16/2026
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/16/2026
Terms of Clearance:

table that charts list comparision

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

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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.

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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

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

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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

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Number of Information Collection (IC) in this ICR: 7

table that charts list of burden

IC Title	Form No.	Form Name
NBB Progress Report	1	Progress Report
NBB Tissue Access Request Form (Foreign Government-Funded Research)	1	Access Request
NBB Tissue Access Request Form (NIH-Funded Research)	1	Access Request
NBB Tissue Access Request Form (Other Entity-Funded Research)	1	Access Request
NBB Tissue Access Request Form (Other US Federal Government-Funded Research)	1	Access Request
NBB Tissue Access Request Form (Private Industry/Commercial-Funded Research)	1	Access Request
NBB Tissue Access Request Form (State Government-Funded Research)	1	Access Request

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ICR Summary of Burden

table that charts list of burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	700	700	0	0	0	0
Annual Time Burden (Hours)	175	175	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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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

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 09/16/2026

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