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

Forms and Documents

Document Name	Status
National Marine Mammal Tissue Bank Form Form and Instruction	Modified
0648-0468 30day 86 FR 26014_20210512.pdf Supplementary Document	2021-05-12
0648-0468 Supporting Statement A.docx Supporting Statement A	2021-05-06
0648-0468 60day 86 FR 2647_20210113.pdf Supplementary Document	2021-04-26

IC Document Collections

IC ID	Document Title	Status
4561	National Marine Mammal Tissue Bank - Tissue Request Form Instruction	Modified
185192	National Marine Mammal Tissue Bank Form Form and Instruction	Modified

ICR Details

OMB Control No: 0648-0468	ICR Reference No: 202104-0648-009
Status: Received in OIRA	Previous ICR Reference No: 201803-0648-006
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/13/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	06/30/2021
Responses	100	110
Time Burden (Hours)	98	90
Cost Burden (Dollars)	76	84

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Abstract: This request is for extension of a current information collection. In 1989, the National Marine Mammal Tissue Bank (NMMTB) was established by the National Marine Fisheries Service (NMFS) Office of Protected Resources (OPR) in collaboration with the National Institute of Standards and Technology (NIST), Minerals Management Service (MMS), and the US Geological Survey/Biological Resources Division (USGS/BRD). The NMMTB provides protocols, techniques, and physical facilities for the long-term storage of tissues from marine mammals. Scientists can request tissues from this repository for retrospective analyses to determine environmental trends of contaminants and other substances of interest. The NMMTB collects, processes, and stores tissues from specific indicator species (e.g., Atlantic bottlenose dolphins, Atlantic white sided dolphins, pilot whales, harbor porpoises), animals from mass strandings, animals that have been obtained incidental to commercial fisheries, animals taken for subsistence purposes, biopsies, and animals from unusual mortality events through two projects, the Marine Mammal Health and Stranding Response Program (MMHSRP) and the Alaska Marine Mammal Tissue Archival Project (AMMTAP). The purposes of this collection of information are: 1) to enable NOAA to allow the scientific community the opportunity to request tissue specimen samples from the NMMTB and, 2) to enable the Marine Mammal Health and Stranding Response Program (MMHSRP) of NOAA to assemble information on all specimens submitted to the National Institute of Standards and Technology’s Biorepository (NIST Biorepository), which includes the NMMTB. Under 16 U.S.C. 1421f section 407(d)(1) of the Marine Mammal Protection Act, the NMFS must establish criteria for access to marine mammal tissues in the NMMTB and make those available for public comment and review. This was accomplished through the proposed rule RIN 0648-AQ51, published on 11/12/2002, and codified in 50 CFR 216.47.

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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:
	86 FR 2647	01/13/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 26014	05/12/2021
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
National Marine Mammal Tissue Bank - Tissue Request Form	NA	NMMTB Tissue Request Form
National Marine Mammal Tissue Bank Form	NA	National Marine Mammal Tissue Bank 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	100	110	0	0	-10	0
Annual Time Burden (Hours)	98	90	0	0	8	0
Annual Cost Burden (Dollars)	76	84	0	0	-8	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:

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Annual Cost to Federal Government: $6,000

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: 05/13/2021

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