Neurobiobank Tissue Access Request (NBB) NIMH

Forms and Documents

Document Name	Status
Form 1 Pre-Mortem Donor Recruitment Form Form and Instruction	Modified
Form 1 Neurobiobank Tissue Access Request Form and Instruction	Modified
NBB OMB SupportStatementA_5.21.15.doc Supporting Statement A	2015-07-08

IC Document Collections

IC ID	Document Title	Status
215924	Pre-Mortem Donor Recruitment Form Form and Instruction	Modified
215923	Neurobiobank Tissue Access Request Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0723	ICR Reference No: 201507-0925-004
Status: Historical Active	Previous ICR Reference No: 201507-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Neurobiobank Tissue Access Request (NBB) NIMH
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 07/17/2015
	Date Received in OIRA: 07/09/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2018	36 Months From Approved
Responses	100	0	0
Time Burden (Hours)	38	0	0
Cost Burden (Dollars)	0	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:
	79 FR 8783	02/13/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 26930	05/11/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Neurobiobank Tissue Access Request	1	NB Tissue Access Request Form
Pre-Mortem Donor Recruitment Form	1	Pre-Mortem Donor Recruitment Form

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ICR Summary 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	100	0	0	100	0	0
Annual Time Burden (Hours)	38	0	0	38	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: NIMH is seeking a three-year OMB approval for two existing Neurobiobank data collections currently without OMB clearance: 1) Pre-Mortem Donor Recruitment Form, and 2) Tissue Access Request Form.

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Annual Cost to Federal Government: $91,158

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

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? Uncollected

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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: 07/09/2015

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