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

Forms and Documents

Document Name	Status
Form 1 NBB Progress Report Form	New
Form 1 NBB Tissue Access Request Form (Other Entity-Funded Research) Form	New
Form 1 NBB Tissue Access Request Form (Private Industry/Commercial-Funded Research) Form	New
Form 1 NBB Tissue Access Request Form (Foreign Government-Funded Research) Form	New
Form 1 NBB Tissue Access Request Form (State Government-Funded Research) Form	New
Form 1 NBB Tissue Access Request Form (Other US Federal Government-Funded Research) Form	New
Form 1 NBB Tissue Access Request Form (NIH-Funded Research) Form	Modified
Att 7_NBB Tissue Request Guidance.pdf Supplementary Document	2024-09-23
Att 9_ IMS Neurobiobank HHS IT Systems PIA.pdf Supplementary Document	2024-09-23
SSA_NBB Tissue Access Request Form_OMB 0925-0723.docx Supporting Statement A	2024-09-23
NIMH 30day notice.pdf Supplementary Document	2024-09-23

IC Document Collections

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

ICR Details

OMB Control No: 0925-0723	ICR Reference No: 202409-0925-004
Status: Received in OIRA	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	Date Submitted to OIRA: 09/24/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2024
Responses	700	400
Time Burden (Hours)	175	100
Cost Burden (Dollars)	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

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

	Total Request	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	400	0	300	0	0
Annual Time Burden (Hours)	175	100	0	75	0	0
Annual Cost Burden (Dollars)	0	0	0	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.

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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: 09/24/2024

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