National Blood Collection and Utilization Survey

Forms and Documents

Document Name	Status
0990-0313 2013 NBCUS_STATIS1.doc Supporting Statement B	2014-05-23
0990-0313 Extension NBCUS Supporting Statement 2018.doc Supporting Statement A	2018-10-26

IC Document Collections

IC ID	Document Title	Status
233811	Blood Collection Centers Other-survey	New
180443	National Blood Collection and Utilization Survey Other-survey	Modified

ICR Details

OMB Control No: 0990-0313	ICR Reference No: 201810-0990-002
Status: Active	Previous ICR Reference No: 201804-0990-001
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: National Blood Collection and Utilization Survey
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: 03/22/2019
	Date Received in OIRA: 10/31/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2022	36 Months From Approved	03/31/2019
Responses	2,920	0	2,800
Time Burden (Hours)	5,840	0	2,800
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of the National Blood Collection and Utilization Survey (NBCUS) is to produce reliable and accurate estimates of national and regional collections, utilization, and safety of all blood products-red blood cells, fresh frozen plasma, and platelets. New to the 2007 NBCUS is the identification and collection of baseline data for biovigilance blood safety monitoring.

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Authorizing Statute(s): US Code: 42 USC 301 Name of Law: 241
  

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 42518	08/22/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 54757	10/31/2018
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
National Blood Collection and Utilization Survey
Blood Collection Centers

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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	2,920	2,800	0	0	120	0
Annual Time Burden (Hours)	5,840	2,800	0	0	3,040	0
Annual Cost Burden (Dollars)	0	0	0	0	0	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: This collection is being submitted for OMB approval on an Extension on a previously approved collection (after three such 3-year approval periods); only very slight changes were made to some of the survey questions to facilitate usability and all other aspects of the program remain the same. There was an adjustment made to the burden hours. It is important to note each facility takes on average 4 hours to complete the survey. This is a change from 3 hours. With the NBCUS occurring biennially (once every two years), this equates to a burden of 1.33/yr on average, or effectively 2 hours per participating facility per year.

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Annual Cost to Federal Government: $242,500

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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.     No

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.     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: 10/31/2018

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