20230901_Blood_NBCUS_SupportingStatementA_0990-0313

Supporting Statement A
2021 National Blood Collection and Utilization Survey
OMB Control Number 0990-0313 - Revision

A.

Justification

1. Circumstances Making the Collection of Information Necessary
This request is for OMB approval of a revised information collection request, the 2023
National Blood Collection and Utilization Survey (NBCUS), OMB No. 0990-0313. For the
2023 NBCUS, minor changes are made to core questions to facilitate usability, and two
supplemental sections (which were added to capture information on the impact of the
COVID-19 pandemic on the blood supply) have been removed. As stated in the Statement
accompanying the 2021 NBCUS, we are not planning to continue the COVID-19
supplemental sections in subsequent surveys.
The Office of the Assistant Secretary for Health (OASH) within HHS is responsible for
conducting a biennial cross-sectional national blood products survey. In addition, the
Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) identified a
need to provide national policy makers with current blood supply and demand data. The
ACBTSA was established to provide policy advice to the Secretary and the Assistant
Secretary for Health. The advice of the ACBTSA is partly dependent on the analysis of
relevant blood collection and utilization data, which is also widely distributed to and used by
the transfusion medicine and blood banking community. This data collection is authorized by
Section 301 of the Public Health Service Act (42 U.S.C. 241) (Attachment A).
The NBCUS is an HHS/OASH funded project conducted biennially. Since 2013, in close
collaboration with OASH, the NBCUS has been performed by the Centers for Disease
Control and Prevention (CDC), which has the requisite technical and scientific resources to
conduct the survey. The response rates for the 2021 NBCUS were 92.5% (49/53) for
community-based blood collection facilities, 74.7% (92/83) for hospital-based blood
collection facilities, and 76.3% (2102/2754) for transfusing hospitals. Based on the previous
iterations of the NBCUS, we expect an overall response rate of almost 75% across all types
of facilities.

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2. Purpose and Use of Information Collection
The objective of the NBCUS is to produce reliable and accurate estimates of national
and regional collections, utilization, and safety of blood products – red blood cells (RBCs),
fresh frozen plasma, and platelets. This survey will significantly improve the federal
government’s capacity to understand the dynamics of blood supply and demand, and to
provide a quantitative basis for assessing strategic and regulatory agendas. An important
purpose of the 2023 survey is to help the federal government continue to monitor trends in
blood availability, which is critical to ensure an adequate supply of safe blood in the United
States. In addition to use by the federal government, data collected in this survey will be of
practical use to the blood banking and hospital transfusion services communities in the
private sector to advance quality standards and procedures. Broad dissemination of the
survey findings through publication of reports (2005-2011 surveys) and open access
scientific papers in peer review journals (2013-2021 surveys) has significantly benefited not
only HHS, but the transfusion medicine community at large by furthering community
discussion of key findings. Data from surveys have informed policy across HHS operating
and staff divisions.
Each question in the proposed survey relates to the analysis objectives detailed in
Section A-16 and lists the questions by survey domains. The general categories of
information to be collected are:
•

General information

•

Blood collection, processing, and testing

•

Blood transfusion

•

Special procedures and product disposition

3. Use of Improved Information Technology and Burden Reduction
The person completing the electronic survey will be given a unique login and password.
Efforts to minimize respondent burden are as follows:
•

The survey is divided into two sections (blood collection and blood transfusion) for
respondents to complete or skip.

•

The survey contains easy to read instructions and skip patterns to avoid having
respondents answer unnecessary questions.

•

The survey contains a glossary of definitions to assist the respondent.

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•

A Survey Helpline email address will be provided. The helpline will field inquiries related
to the survey and will be available 24 hours a day to answer questions related to the
survey.

•

For institutions that have not responded, an abbreviated version of the survey containing
critical items will be distributed. The survey will be made available both electronically and
in paper form.

4. Efforts to Identify Duplication and Use of Similar Information
The NBCUS has been conducted by HHS/OASH since 2005, with CDC involvement
beginning in 2013. Data on blood collection and utilization on a national scale are not
available from any other source. While segments of the blood collection industry collect
some information, it is often proprietary and not available to the government or the public at
large.
5. Impact on Small Businesses or Other Small Entities
The target population consists of U.S. blood collection facilities and transfusing
hospitals. Every effort is made to minimize the burden on small businesses when collecting
information.
6. Consequences of Collecting the Information Less Frequent Collection
The NBCUS is administered biennially. The rapidly changing environment in blood
supply and demand makes it important to have regular, periodic data describing the state of
U.S. blood collections and transfusions for understanding the dynamics of blood safety and
availability. These data have become even more crucial with the need to help ensure patient
safety by monitoring and identifying errors in transfusion medicine and related therapies.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
This request fully complies with 5 CFR 1320.5. There are no special circumstances
associated with this data collection activity.
8. Comments in Response to the Federal Register Notice/Outside Consultation
The 60-day notice for public comment was published in the Federal Register, Volume
88, No. 185, on Thursday, September 26, 2023, pp. 66010 (Attachment B). A total of one
comment from America’s Blood Centers organizations was received. Responses are
imbedded in the public comment document (Attachment C).
9. Explanation of any Payment/Gift to Respondents
Remuneration of respondents is not provided.

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10. Assurance of Confidentiality Provided to Respondents
The Privacy Act of 1974 (5 U.S.C. 552a) does not apply to the proposed data collection
since respondents are not human subjects, but institutions; and no patient/donor identifiers
are collected. Therefore, no Institutional Review Board review is required. Data identifying
institutions will be kept private to the extent allowed by law.
11. Justification for Sensitive Questions
Information on issues of a sensitive nature involving persons is not being sought.
12. Estimates of Annualized Hour and Cost Burden
12A. The burden for the NBCUS survey is summarized in the table below (estimated
using references to 2021 NBCUS). Each institution that is asked to complete the survey is
considered to be a respondent. The respondents to this survey are hospitals andblood
collection centers, The number of respondents is 2,890. It is estimated that each respondent
will spend about 212 minutes (3.5 burden hours total; or 1 hour and 46 minutes burden
hour/year) completing the questionnaire. The hourly burden estimates are based on 212
minutes from previous years’ experience administering the survey and accounts for the
reduction in questions in the 2023 NBCUS.
12A. Estimated Annualized Burden Hours
No.
Type of
No. of
Responses
Respondent Respondents
per
Respondent
Transfusing
2754
1
Hospitals
Hospital
83
1
Blood Banks
Communitybased blood
53
1
center
Total
2,890

Average Burden
per Response (in
hours)

Total Burden
Hours

1 hour, 46 min

4,865

1 hour, 46 min

147

1 hour, 46 min

94
5,106

12B. The average annualized response burden cost to respondents is estimated to be
$190,862 based on an hourly wage of $37.38 per hour. The hourly wage estimate is based
on the Bureau of Labor Statistics’ National Compensation Survey mean hourly wage data
for health-related occupations in 2022.

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12B. Estimated Annualized Respondent Burden Costs
Total annual
Type of respondents response
Hourly wage rate
burden hours
Hospitals, blood
collection centers,
5,106
$37.38
cord blood banks

Respondent cost
$190,862

13. Estimates of other Total Annual Cost Burden to Respondents or
Recordkeepers/Capital Costs
There is no other capital or start-up costs, and no maintenance or service cost
components for this information collection.
14. Annualized Cost to Federal Government
All survey operations including survey development, data collection, analysis, and
preparation of the final report are contracted to the CDC by OASH. The total cost of this
fixed price Interagency Agreement (IAA) is $242,500 annually.
15. Explanation for Program Changes or Adjustments
This collection is being submitted for OMB approval as a revision on a previously
approved collection (after three such 3-year approval periods); minor changes were made to
some of the survey questions to facilitate usability and all other aspects of the program
remain the same. The draft 2023 survey reduces the number of data items collected by
eliminating supplemental sections added to both Section B and Section C to capture
information on the impact of the COVID-19 pandemic on the blood supply during the course
of 2020. The draft 2023 survey is shorter than the 2019 and 2021 surveys. It is estimated
that each facility takes an average 3.5 hours to complete the survey.

Number of data items collected from facilities during 2013-2021.
Number of data items collected
NBCUS Survey section

2015

2017

2019

2021

2023

Section B (Blood Centers)

177

250

246

202

207

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--

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COVID-19 Supplemental Section -B

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Section C (Hospitals)

187

COVID-19 Supplemental Section -C

211

194

181

180

--

--

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16. Plans for Tabulation and Publication and Project Time Schedule
The timetable for key activities for the 2023 survey is as follows:
Timeline
TBD

Receive OMB clearance

December 2023

Finalize NBCUS 2023 in REDCap

February 2024

Confirm contact list and submit REDCap survey to OASH for
approval

March 2024

Begin data collection for 2023 survey

July 2024

End data collection

August 2024

Begin data analysis

2025

Publish final comprehensive report

Statistical tabulations of results for each question will be presented. These will be broken
down by institution type, services provided, United States Public Health Service (USPHS)
region, etc. Selected examples of types of analyses proposed include:
•

Analyses of trends in the U.S. blood supply

•

Total supply of blood collected in the U.S. broken down by type (e.g., whole blood (WB)
allogeneic, WB autologous, WB directed, RBC apheresis, platelets, plasma)

•

Total transfusions in the U.S. broken down by type (e.g., WB, RBC, platelets, non-RBC
components transfused)

•

National estimates of all whole blood and blood component units outdated by blood
centers and hospitals

•

Component modifications – Irradiation, leukocyte reduction by blood centers and
hospitals

•

Rates of confirmed positives and false positives by bacterial testing methods

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•

Number of adverse events (e.g., Transfusion-related acute lung injury (TRALI),
Transfusion-associated circulatory overload (TACO), Hemolysis, Allergic reactions, etc.)
After final validation of results a comprehensive report of findings from the survey will be

published. The 2005 through 2021 Nationwide Blood Collection and Utilization reports are
available at www.hhs.gov/ash/bloodsafety.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
The program agrees to show the expiration date.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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