[Federal Register Volume 89, Number 190 (Tuesday, October 1, 2024)]
[Notices]
[Pages 79923-79925]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22475]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day--24-24IW; Docket No. CDC-2024-0070]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
federal agencies the opportunity to comment on a proposed information 
collection, as required by the Paperwork Reduction Act of 1995. This 
notice invites comment on a proposed information collection project 
titled Becton Dickinson BACTEC\TM\ Blood Culture Media Bottles Shortage 
Impact Questionnaire, which will assess the impact of the Becton 
Dickinson (BD) BACTEC\TM\ blood culture media bottles supply shortage 
on individual facilities and how CDC NHSN bloodstream infection 
surveillance might be affected.

DATES: CDC must receive written comments on or before December 2, 2024.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0070 by either of the following methods:
    <bullet> Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
    <bullet> Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS H21-8, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.regulations.gov) or by U.S. mail to the address listed 
above.

[[Page 79924]]


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570; 
Email: <a href="/cdn-cgi/l/email-protection#036c6e61436067602d646c75"><span class="__cf_email__" data-cfemail="ec83818eac8f888fc28b839a">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected;
    4. 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 
submissions of responses; and
    5. Assess information collection costs.

Proposed Project

    National Healthcare Safety Network (NHSN) Becton Dickinson 
BACTEC\TM\ Blood Culture Media Bottles Shortage Impact Questionnaire--
New--National Center for Emerging and Zoonotic Infection 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 No. 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. 
Enrollment in NHSN has continuously increased, with over 37,000 
actively reporting healthcare facilities across the U.S. Of the total 
enrolled healthcare facilities, there are over 6,000 acute care 
facilities. NHSN currently has eight components, and the collection of 
information is authorized by the Public Health Service Act (42 U.S.C. 
242b, 242k, and 242m (d)).
    Data reported under NHSN's Patient Safety Component are used to 
determine the magnitude of the healthcare-associated adverse events and 
trends in the rates of the events, in the distribution of pathogens, 
and in the adherence to prevention practices. Data will help detect 
changes in the epidemiology of adverse events resulting from new 
medical therapies and changing patient risks. Additionally, reported 
data is being used to describe the epidemiology of antimicrobial use 
and resistance and to better understand the relationship of 
antimicrobial therapy to this rising problem.
    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 US 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) BACTEC 
(TM) 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 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) BACTEC (TM) blood culture media 
bottles for their facility. The questions will be collected 
electronically via the NHSN application.
    CDC requests OMB approval for an estimated 2,334 annual burden 
hours. There are no cost to respondents other than their time to 
participate.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Infection Preventionist/        Blood Culture              3,500               1           20/60           1,167
 Microbiologist.                 Bottle Shortage
                                 Questionnaire
                                 (Jul-Oct).
Infection Preventionist/        Blood Culture              3,500               1           20/60           1,167
 Microbiologist.                 Bottle Shortage
                                 Questionnaire
                                 (Nov-Mar).
                               ---------------------------------------------------------------------------------

[[Page 79925]]

 
    Total.....................  ................  ..............  ..............  ..............           2,334
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2024-22475 Filed 9-30-24; 8:45 am]
BILLING CODE 4163-18-P


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