Draft Guideline for Prevention and Control of Infections in Neonatal Intensive Care Unit Patients: Draft Recommendations for the Prevention and Control of Staphylococcus aureus in Neonatal Intensive Care Unit Patients, 46014 [2019-18907]

Download as PDF 46014 Federal Register / Vol. 84, No. 170 / Tuesday, September 3, 2019 / Notices 4. Healthcare Safety and Quality Improvement Research (HSQR) Date: October 10–11th, 2019 (Open from 7:30 a.m. to 8:00 a.m. on October 10th and closed for remainder of the meeting) 5. Healthcare Information Technology Research (HITR) Date: October 24th, 2019 (Open from 8:00 a.m. to 8:30 a.m. on October 24th and closed for remainder of the meeting) Agenda items for these meetings are subject to change as priorities dictate. Virginia L. Mackay-Smith, Associate Director, AHRQ. [FR Doc. 2019–18928 Filed 8–30–19; 8:45 am] BILLING CODE 4160–90–P • Mail: Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Attn: Docket No. CDC– 2019–0077, HICPAC Secretariat, 1600 Clifton Rd. NE, Mailstop A07, Atlanta, Georgia 30329. Instructions: Submissions via https:// regulations.gov are preferred. All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to https:// regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC–2019–0077] Draft Guideline for Prevention and Control of Infections in Neonatal Intensive Care Unit Patients: Draft Recommendations for the Prevention and Control of Staphylococcus aureus in Neonatal Intensive Care Unit Patients Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment. AGENCY: The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comment on the Draft Guideline for Prevention and Control of Infections in Neonatal Intensive Care Unit Patients: Draft Recommendations for the Prevention and Control of Staphylococcus aureus in Neonatal Intensive Care Unit Patients (‘‘Draft Guideline’’). The Draft Guideline provides new, evidence-based recommendations specific to the prevention and control of Staphylococcus aureus (S. aureus), including methicillin-resistant S. aureus (MRSA) and methicillin-sensitive S. aureus (MSSA), in neonatal intensive care unit (NICU) patients. DATES: Written comments must be received on or before November 4, 2019. ADDRESSES: You may submit comments, identified by Docket No. CDC–2019– 0077, by any of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. khammond on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:24 Aug 30, 2019 Jkt 247001 Kendra Cox, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop A–07, Atlanta, Georgia 30329; Telephone: (404) 639–4000. SUPPLEMENTARY INFORMATION: Public Participation Interested persons or organizations are invited to participate by submitting written views, recommendations, and data. Please note that comments received, including attachments and other supporting materials, are part of the public record and are subject to public disclosure. Comments will be posted on https://www.regulations.gov. Therefore, do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. If you include your name, contact information, or other information that identifies you in the body of your comments, that information will be on public display. CDC will review all submissions and may choose to redact, or withhold, submissions containing private or proprietary information such as Social Security numbers, medical information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. CDC will carefully consider all comments submitted in preparation of the final Guideline for Prevention and Control of Infections in Neonatal Intensive Care Unit Patients and may revise the final document as appropriate. The Draft Guideline, located in the ‘‘Supporting & Related Material’’ tab of the docket, provides new, evidencebased recommendations specific to the Frm 00071 Dated: August 28, 2019. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention. [FR Doc. 2019–18907 Filed 8–30–19; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3240] List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act AGENCY: Background PO 00000 prevention and control of S. aureus, including MRSA and MSSA, in NICU patients, including active surveillance testing and decolonization. The Draft Guideline is intended for use by infection prevention staff, healthcare epidemiologists, healthcare administrators, nurses, neonatologists, other healthcare providers, and persons responsible for developing, implementing, and evaluating infection prevention and control programs for NICUs. The guideline can also serve as a resource for societies or organizations to develop more detailed implementation guidance for the prevention of infection in NICU patients. The Healthcare Infection Control Practices Advisory Committee (HICPAC) worked with national partners, academicians, public health professionals, healthcare providers, and other partners to develop this Draft Guideline. HICPAC includes representatives from public health, infectious diseases, regulatory and other federal agencies, professional societies, and other stakeholders. The draft recommendations in this Draft Guideline are informed by a systematic review of the best available literature through February 2017 and of relevant references published since February 2017 suggested by subject matter experts. The Appendix, located in the ‘‘Supporting & Related Material’’ tab of the docket, contains search strategies, Evidence Tables containing study-level data examined, and GRADE Tables which aggregate the overall strength and direction of the evidence. This Draft Guideline will not be a federal rule or regulation. Fmt 4703 Sfmt 4703 Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is SUMMARY: E:\FR\FM\03SEN1.SGM 03SEN1

Agencies

[Federal Register Volume 84, Number 170 (Tuesday, September 3, 2019)]
[Notices]
[Page 46014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18907]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2019-0077]


Draft Guideline for Prevention and Control of Infections in 
Neonatal Intensive Care Unit Patients: Draft Recommendations for the 
Prevention and Control of Staphylococcus aureus in Neonatal Intensive 
Care Unit Patients

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

ACTION: Notice with comment.

-----------------------------------------------------------------------

SUMMARY: The Centers for Disease Control and Prevention (CDC), in the 
Department of Health and Human Services (HHS), announces the opening of 
a docket to obtain comment on the Draft Guideline for Prevention and 
Control of Infections in Neonatal Intensive Care Unit Patients: Draft 
Recommendations for the Prevention and Control of Staphylococcus aureus 
in Neonatal Intensive Care Unit Patients (``Draft Guideline''). The 
Draft Guideline provides new, evidence-based recommendations specific 
to the prevention and control of Staphylococcus aureus (S. aureus), 
including methicillin-resistant S. aureus (MRSA) and methicillin-
sensitive S. aureus (MSSA), in neonatal intensive care unit (NICU) 
patients.

DATES: Written comments must be received on or before November 4, 2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0077, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Division of Healthcare Quality Promotion, National 
Center for Emerging and Zoonotic Infectious Diseases, Centers for 
Disease Control and Prevention, Attn: Docket No. CDC-2019-0077, HICPAC 
Secretariat, 1600 Clifton Rd. NE, Mailstop A07, Atlanta, Georgia 30329.
    Instructions: Submissions via https://regulations.gov are preferred. 
All submissions received must include the agency name and Docket 
Number. All relevant comments received will be posted without change to 
https://regulations.gov, including any personal information provided. 
For access to the docket to read background documents or comments 
received, go to https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Kendra Cox, Division of Healthcare 
Quality Promotion, National Center for Emerging and Zoonotic Infectious 
Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, Mailstop A-07, Atlanta, Georgia 30329; Telephone: (404) 639-4000.

SUPPLEMENTARY INFORMATION:

Public Participation

    Interested persons or organizations are invited to participate by 
submitting written views, recommendations, and data.
    Please note that comments received, including attachments and other 
supporting materials, are part of the public record and are subject to 
public disclosure. Comments will be posted on https://www.regulations.gov. Therefore, do not include any information in your 
comment or supporting materials that you consider confidential or 
inappropriate for public disclosure. If you include your name, contact 
information, or other information that identifies you in the body of 
your comments, that information will be on public display. CDC will 
review all submissions and may choose to redact, or withhold, 
submissions containing private or proprietary information such as 
Social Security numbers, medical information, inappropriate language, 
or duplicate/near duplicate examples of a mass-mail campaign. CDC will 
carefully consider all comments submitted in preparation of the final 
Guideline for Prevention and Control of Infections in Neonatal 
Intensive Care Unit Patients and may revise the final document as 
appropriate.

Background

    The Draft Guideline, located in the ``Supporting & Related 
Material'' tab of the docket, provides new, evidence-based 
recommendations specific to the prevention and control of S. aureus, 
including MRSA and MSSA, in NICU patients, including active 
surveillance testing and decolonization.
    The Draft Guideline is intended for use by infection prevention 
staff, healthcare epidemiologists, healthcare administrators, nurses, 
neonatologists, other healthcare providers, and persons responsible for 
developing, implementing, and evaluating infection prevention and 
control programs for NICUs. The guideline can also serve as a resource 
for societies or organizations to develop more detailed implementation 
guidance for the prevention of infection in NICU patients.
    The Healthcare Infection Control Practices Advisory Committee 
(HICPAC) worked with national partners, academicians, public health 
professionals, healthcare providers, and other partners to develop this 
Draft Guideline. HICPAC includes representatives from public health, 
infectious diseases, regulatory and other federal agencies, 
professional societies, and other stakeholders.
    The draft recommendations in this Draft Guideline are informed by a 
systematic review of the best available literature through February 
2017 and of relevant references published since February 2017 suggested 
by subject matter experts. The Appendix, located in the ``Supporting & 
Related Material'' tab of the docket, contains search strategies, 
Evidence Tables containing study-level data examined, and GRADE Tables 
which aggregate the overall strength and direction of the evidence.
    This Draft Guideline will not be a federal rule or regulation.

    Dated: August 28, 2019.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2019-18907 Filed 8-30-19; 8:45 am]
 BILLING CODE 4163-18-P

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