National Tissue Recovery through Utilization Survey (NTRUS)

Forms and Documents

Document	Type	Status	Availability
30-day Federal Register, Volume 81 Issue 246 (Thursday, December 22, 2016).htm	Supplementary Document	Uploaded 2016-12-22	Available
0990-NTRUS_SupportStatement-B_rev_19June2017.docx	Supporting Statement B	Uploaded 2017-06-19	Available
NTRUS_SupportStatement-A_rev_19June2017.doc	Supporting Statement A	Uploaded 2017-06-19	Available
FRN 60-day_7Sept2016.pdf	Supplementary Document	Uploaded 2016-12-22	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
225389	Communicable disease testing and adverse outcome reports	Other-survey	New
225388	Tissue distribution	Other-survey	New
225387	Tissue storage	Other-survey	New
225386	Tissue processing	Other-survey	New
225385	Referrals, authorization, and informed consent; Tissue recovery and acquisition	Other-survey	New
224946	Tissue bank activities, tissue types handled, and inspections	Other-survey	New

ICR Details

OMB Control No: 0990-0457	ICR Reference No: 201609-0990-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: National Tissue Recovery through Utilization Survey (NTRUS)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/20/2017
	Date Received in OIRA: 01/31/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2020	36 Months From Approved
Responses	383	0	0
Time Burden (Hours)	219	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This survey is being conducted to generate national estimates of recovery through utilization activity related to donated human tissue for calendar years 2012 and 2015. This survey will compare metrics across three data collection periods that includes results from a 2007 survey, which was the most recent year this data was collected. The survey instrument, data collection and analysis methods will be similar to the 2007 survey. Rapid identification and quarantine of tissue is critical should a tissue be suspected to have a donor-derived infection. However, recent information on the types and quantity of tissue distributed in the US and internationally is unknown.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Section 301 of the 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:
	81 FR 61703	09/07/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 93945	12/22/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Tissue bank activities, tissue types handled, and inspections
Tissue processing
Tissue storage
Communicable disease testing and adverse outcome reports
Referrals, authorization, and informed consent; Tissue recovery and acquisition
Tissue distribution

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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	383	0	0	383	0	0
Annual Time Burden (Hours)	219	0	0	219	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: New data collection.

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Annual Cost to Federal Government: $42,240

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]? Yes

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: 01/31/2017

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