Neurobiobank Tissue Access Request (NBB) NIMH

Forms and Documents

Document	Type	Status	Availability
Form 1 NeuroBioBank Tissue Access Request Form	Form and Instruction	New	Available
Form 1 Pre-Mortem Donor Recruitment Form	Form and Instruction	Removed	Available
Form 1 Neurobiobank Tissue Access Request	Form and Instruction	Removed	Available
30-day FRN 2018-14490.pdf	Supplementary Document	Uploaded 2018-07-09	Repair queued
NBB.SSAExtension.06.28.18.docx	Supporting Statement A	Uploaded 2018-06-29	Available
Att 3 - IMS Neurobiobank HHS IT Systems PIA (103113)1.pdf	Supplementary Document	Uploaded 2018-06-28	Repair queued
Att 2 - NBB Tissue Request Guidance.pdf	Supplementary Document	Uploaded 2018-06-28	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
231996	NeuroBioBank Tissue Access Request Form	Form and Instruction	New
215924	Pre-Mortem Donor Recruitment Form	Form and Instruction	Removed
215923	Neurobiobank Tissue Access Request	Form and Instruction	Removed

ICR Details

OMB Control No: 0925-0723	ICR Reference No: 201806-0925-001
Status: Active	Previous ICR Reference No: 201507-0925-004
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Neurobiobank Tissue Access Request (NBB) NIMH
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/09/2018
	Date Received in OIRA: 07/10/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2021	36 Months From Approved	08/31/2018
Responses	225	0	100
Time Burden (Hours)	56	0	38
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:
	83 FR 17558	04/20/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 31557	07/06/2018
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
Pre-Mortem Donor Recruitment Form	1	Pre-Mortem Donor Recruitment Form
Neurobiobank Tissue Access Request	1	NB Tissue Access Request Form
NeuroBioBank Tissue Access Request Form	1	NBB Tissue Access Request 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	225	100	0	175	-50	0
Annual Time Burden (Hours)	56	38	0	43	-25	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: Miscellaneous Actions

Short Statement: The increase in estimated hourly burden and respondent cost noted in Section A12 above, as compared to the estimates in our 2015 submission, is directly related to the growth and expansion of the NBB within the scientific community.

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Annual Cost to Federal Government: $80,784

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? 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: 07/10/2018

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