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In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “NHSN Becton Dickinson BACTEC(TM) Blood Culture Media Bottles Shortage Impact Questionnaire” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a notice on October 1, 2024, to obtain comments from the public and affected agencies. CDC received no comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
e.g.,
permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain.
Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.
Proposed Project
National Healthcare Safety Network (NHSN) Becton Dickinson BACTECTM Blood Culture Media Bottles Shortage Impact Questionnaire (OMB Control No. 0920-1442, Exp. 02/28/2028)—Revision—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Division of Healthcare Quality Promotion (DHQP), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC) collects data from healthcare facilities in the National Healthcare Safety Network (NHSN) under OMB Control Number 0920-0666. NHSN provides facilities, health departments, states, regions, and the nation with data necessary to identify problem areas, measure the progress of prevention efforts, and ultimately eliminate healthcare-associated infections (HAIs) nationwide. NHSN also allows healthcare facilities to track blood safety errors and various HAI prevention practice methods such as healthcare personnel influenza vaccine status and corresponding infection control adherence rates.
NHSN's data is used to aid in the tracking of HAIs and guide infection prevention activities/practices that protect patients. The Centers for Medicare and Medicaid Services (CMS) and other payers use these data to determine incentives for performance at healthcare facilities across the U.S. and surrounding territories, and members of the public may use some protected data to inform their selection among available providers. Each of these parties is dependent on the completeness and accuracy of the data. CDC and CMS work closely and are fully committed to ensuring complete and accurate reporting, which are critical for protecting patients and guiding national, state, and local prevention priorities.
The U.S. Food and Drug Administration (FDA) posted an announcement regarding interruptions in the supply of Becton Dickinson (BD) BACTECTM blood culture media bottles because of recent supplier issues. The disruption in the supply is expected to impact patient diagnosis, follow up patient management, and antimicrobial stewardship efforts. The FDA and other entities recommend that facilities, laboratories, and health care providers consider conservation strategies to prioritize the use of blood culture media bottles, preserving the supply for patients at highest risk. This information collection request was initially approved under Emergency processing procedures on 9/27/2024 as OMB Control No. 0920-1442. This package is submitted as a Revision to allow data collection to continue beyond the initial approval period and
( printed page 24630)
includes a new data collection instrument that will assess the impact of the supply shortage on individual facilities and how CDC NHSN bloodstream infection surveillance might be affected. Facilities enrolled in the NHSN Patient Safety Component will be asked questions regarding the impact of the Becton Dickinson (BD) BACTECTM blood culture media bottles for their facility. The questions will be collected electronically via the NHSN application.
CDC requests OMB approval for one year and a total of 2,334 annual burden hours. There is no cost to respondents other than their time to participate.
Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention.