Protocol for Access to Tissue Specimen Samples from the National Marine Mammal Tissue Bank

Forms and Documents

Document Name	Status
Application ffor Tissue Samples from the Marine Mammal Tissue Bank and reports on research Form and Instruction	Modified
0568 30d FRN pub 031918_11967.pdf Supplementary Document	2018-03-22
0468 frn 101917_48702.pdf Supplementary Document	2018-03-22
0468 SS 061818.docx Supporting Statement A	2018-06-18

IC Document Collections

IC ID	Document Title	Status
4561	Application ffor Tissue Samples from the Marine Mammal Tissue Bank and reports on research Form and Instruction	Modified
185192	Submission of Information on Specimen Samples Instruction	Modified

ICR Details

OMB Control No: 0648-0468	ICR Reference No: 201803-0648-006
Status: Active	Previous ICR Reference No: 201412-0648-013
Agency/Subagency: DOC/NOAA	Agency Tracking No:
Title: Protocol for Access to Tissue Specimen Samples from the National Marine Mammal Tissue Bank
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/19/2018
	Date Received in OIRA: 03/22/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2021	36 Months From Approved	06/30/2018
Responses	110	0	140
Time Burden (Hours)	90	0	160
Cost Burden (Dollars)	84	0	161

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Abstract: The current purpose of this collection of information is to enable NOAA to allow the scientific community the opportunity to request tissue specimen samples from the National Marine Tissue Bank (NMMTB) as well as for tissue samples to be submitted. This information collection is being renewed to enable the Marine Mammal Health and Stranding Response Program (MMHSRP) of NOAA to assemble information on all specimens submitted to the National Biomonitoring Specimen Bank (Bank), which includes the NMMTB. The PIrvacy Act Statement is on the program Web page.

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Authorizing Statute(s): US Code: 16 USC 31 Name of Law: Marine Mammal Protection 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:
	82 FR 48702	10/19/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 11967	03/19/2018
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
Submission of Information on Specimen Samples	NA	NMMTB form
Application ffor Tissue Samples from the Marine Mammal Tissue Bank and reports on research	NA, NA	NMMTB Tissue Request Form ,   tissue 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	110	140	0	0	-30	0
Annual Time Burden (Hours)	90	160	0	0	-70	0
Annual Cost Burden (Dollars)	84	161	0	0	-77	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: The estimated number of requests for samples from the ESB has decreased over the years, and the number has been revised to reflect what has been observed recently (approximately 5 requests per year). Also, the estimated response time for the Tissue Bank Submission Form was changed from 1 hour to 45 minutes, based on most recent respondent feedback.

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Annual Cost to Federal Government: $800

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: 03/22/2018

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