Notice2024-22475
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 1, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 190 (Tuesday, October 1, 2024)</title>
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[Federal Register Volume 89, Number 190 (Tuesday, October 1, 2024)]
[Notices]
[Pages 79923-79925]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="http://www.regulations.gov">www.regulations.gov</a>. 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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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)
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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).
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[[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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