Neurobiobank Tissue Access Request (NBB) NIMH

Forms and Documents

Document Name	Status
Form 1 NeuroBioBank Tissue Access Request Form Form and Instruction	Modified
SSA_NBB Tissue Access Request Form_final_101021.docx Supporting Statement A	2021-09-20
pub 30-day FRN2021-20076.pdf Supplementary Document	2021-09-20
Attachment 3 PIA.pdf Supplementary Document	2021-09-20
Att 2 - Updated NBB Tissue Request Guidance_09.03.21.pdf Supplementary Document	2021-09-20

IC Document Collections

IC ID	Document Title	Status
231996	NeuroBioBank Tissue Access Request Form Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0723	ICR Reference No: 202109-0925-003
Status: Received in OIRA	Previous ICR Reference No: 201806-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Neurobiobank Tissue Access Request (NBB) NIMH
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/21/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	11/30/2021
Responses	400	225
Time Burden (Hours)	100	56
Cost Burden (Dollars)	0	0

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Abstract: The National Institute of Mental Health (NIMH), National Institute of Neurological Diseases and Stroke (NINDS) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), components of the National Institutes of Health (NIH), created the NIH Neurobiobank (NBB), a centralized program to coordinate the acquisition, receipt, storage and dissemination of human brains, related biospecimens, and associated clinical data, via a federation of several contracted brain and tissue repository sites. The goal of this project is to increase the availability of, and access to, high quality specimens for research in order to understand the neurological bases of diseases and mental disorders.

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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:
	86 FR 35815	07/07/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 51906	09/20/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
NeuroBioBank Tissue Access Request Form	1	NBB Tissue Access Request Form

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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	400	225	0	175	0	0
Annual Time Burden (Hours)	100	56	0	44	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: No

Burden Reduction Due to:

Short Statement: There have been changes to the information collected by the NBB Tissue Access Request Form (Attachment 1). Based upon a review of the past response rate, NIMH has updated the number of estimated respondents to 400 from 225. Given the further streamlining of the form, NIMH estimates the form will take only 15 minutes to complete. The “Requestor Information” portion of the request form now asks for the name and email address for the Principal Investigator if that individual is not the requestor. The “Research Funding Information” portion of the request form has been streamlined for the requestors. Additionally, this portion of the request form now asks if the researched related to the request is supported by funding from the NIH. If the funding is NIH-related, the requestor must provide information on whether the funding is extramural or intramural, which IC it is affiliated with, and the six-digit project serial number.

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Annual Cost to Federal Government: $58,723

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: 09/21/2021

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