National Blood Collection and Utilization Survey

OMB Control No: 0990-0313	ICR Reference No: 202109-0990-003
Status: Received in OIRA	Previous ICR Reference No: 201810-0990-002
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: National Blood Collection and Utilization Survey
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/28/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	03/31/2022
Responses	2,266	2,920
Time Burden (Hours)	4,532	5,840
Cost Burden (Dollars)	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. The biennial NBCUS facilitates the federal government’s capacity to understand the dynamics of blood supply and demand and provides a quantitative basis for assessing strategic and regulatory agendas. The data is also of practical use to the blood banking and hospital transfusion services communities in the private sector to advance quality standards and procedures.

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

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 15953	03/25/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 51902	09/17/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title Form No. Form Name National Blood Collection and Utilization Survey Blood Collection Centers

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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	2,266	2,920	0	-584	-70	0
Annual Time Burden (Hours)	4,532	5,840	0	-1,168	-140	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The total number of burden hours changed due to a decrease in the number of respondents selected for the survey. For example, restrictions were placed on the target population – specifically, hospitals reporting fewer than 100 inpatient surgeries per year were excluded since they contribute little to either collections or blood product utilization. There were no changes to the number of burden hours per response. Although the revised survey reduces the number of data items collected for the blood collection and blood transfusion sections, questions were added to capture information on the impact of the COVID-19 pandemic on the blood supply during the course of 2020.

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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? No

Agency Contact: Debbie Seem 202 795-7619 [email protected]

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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: 09/28/2021

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