Emergency Request Memo BD BACTEC(TM)

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
_______________________________________________________________________________________
Centers for Disease Control
and Prevention (CDC)
Atlanta GA 30341-3724

September 13, 2024
Dominic Mancini
Deputy Director
Office of Information and Regulatory Affairs
Office of Management and Budget
Washington, DC
Subject: Request for Emergency Review and Clearance
Dear Mr. Mancini:
Pursuant to Office of Management and Budget (OMB) procedures established at 5 CFR Part 1320,
Controlling Paperwork Burdens on the Public, I request that the proposed information collection project,
Becton Dickinson BACTECTM Blood Culture Media Bottles Shortage Impact Questionnaire be processed
in accordance with section 1320.13, Emergency Processing.
I have determined that this information must be collected prior to the expiration of time periods
established under Part 1320, and that this information is essential in the continued and uninterrupted
operation of the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network
(NHSN).
On July 10, 2024, The U.S. Food and Drug Administration (FDA) updated the Medical Device Shortages
List to include BD BACTEC blood culture media bottles and issued a letter to Health Care Providers
regarding the disruption in supply1. The supply disruption is expected to impact patient diagnosis, follow
up patient management, bloodstream infection surveillance, and antimicrobial stewardship efforts. The
FDA has recommended that health care facilities, laboratories, and health care providers develop
strategies to prioritize the use of blood culture media bottles, based on clinical need, to maintain quality
and safety of patient care. On July 23, 2024, the CDC issued a Health Alert Network Health Advisory to
inform healthcare providers, laboratory professionals, healthcare facility administrators, and state, tribal,
local, and territorial health departments of a critical shortage of Becton Dickinson (BD) BACTEC™
blood culture media bottles2.
Blood cultures identify microorganism that cause infections and are critical for diagnosing patients with
bloodstream infections and associated conditions including catheter-related bloodstream infections and
sepsis. Blood cultures also assist health care providers in determining and guiding optimal therapy for
treatment of these infections. Most blood cultures in the United States are performed using continuousmonitoring blood culture systems; the BD continuous-monitoring blood culture system is used in about
half of all U.S. laboratories and is only compatible with BD BACTEC™ blood culture media bottles.
Federal laws and regulations require mandatory reporting of facility-specific adverse events, prevention
practice adherence, and other public health data. CDC NHSN is the nation’s most widely used
healthcare-associated infection (HAI) tracking system and provides facilities, health departments, states,
regions, and the nation with data needed to identify problem areas, measure progress of prevention
efforts, and ultimately eliminate HAIs. CMS quality reporting programs use HAI data reported to NHSN

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
_______________________________________________________________________________________
Centers for Disease Control
and Prevention (CDC)
Atlanta GA 30341-3724

to determine incentives for performance at healthcare facilities across the US and surrounding territories,
and members of the public may use some protected data to inform their selection among available
providers, specifically bloodstream infection surveillance data. Facilities that fail to report quality
measure data are subject to partial payment reduction in the applicable Medicare Fee-for-Service
payment system. Many healthcare facilities in states without HAI reporting legislation also voluntarily
submit HAI data to NHSN.
CDC and CMS work closely and are fully committed to ensuring complete and accurate reporting of HAI
data, which are critical for protecting patients and guiding national, state, and local prevention priorities.
The interruptions in the supply of Becton Dickinson (BD) BACTECTM blood culture media bottles will
likely affect facility reporting of HAIs (bloodstream infection surveillance data) to NHSN and may
ultimately affect facility payment from CMS. CDC NHSN cannot reasonably comply with the normal
clearance process given the fact that this shortage may affect mandated CMS pay-for-performance
quality reporting programs. This information collection request (ICR) includes a new data collection
instrument and needs to go forward as an emergency request to assess the shortage's impact on facilities
and bloodstream infection surveillance. Approval is requested for six months, with an expiration date of
April 30, 2025.
Please provide an approval/disapproval determination of this request to collect information under an
emergency clearance by close of business 9/27/2024.
Respectfully,

_______________________________________
Daniel B. Jernigan, MD MPH
Director, National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease Control and Prevention

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
_______________________________________________________________________________________
Centers for Disease Control
and Prevention (CDC)
Atlanta GA 30341-3724

1.

2.

U.S. Food & Drug Administration. Disruptions in Availability of BD BACTEC Blood Culture Media Bottles
https://www.fda.gov/medical-devices/letters-health-care-providers/disruptions-availability-bd-bactec-blood-culture-media-bottlesletter-health-care-providers. Accessed September 5, 2024.
Centers for Disease Control and Prevention. Disruptions in Availability of Becton Dickinson (BD) BACTEC™ Blood Culture
Bottles. https://emergency.cdc.gov/han/2024/han00512.asp. Accessed September 5, 2024.