83 FR 26688 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 111 (June 8, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 111 (June 8, 2018)
| Page Range | 26688-26690 | |
| FR Document | 2018-12372 |
[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)] [Notices] [Pages 26688-26690] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12372] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-18-18ACN; Docket No. CDC-2018-0042] 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. ----------------------------------------------------------------------- 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 and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Undetermined cause of Serratia marcescens infections--Multiple States, 2018. The goal of this investigation is to identify potential risk factors leading to an outbreak of Serratia marcescens infections among U.S. healthcare patients. Data will be used to identify a cause of the infections and prevent additional events from occurring. DATES: CDC must receive written comments on or before August 7, 2018. ADDRESSES: You may submit comments, identified by Docket No. CDC-2018- 0042 by any of the following methods:Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments. Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329. Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to Regulations.gov. Please note: Submit all comments through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above. 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 Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]. 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 [[Page 26689]] 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; and 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. 5. Assess information collection costs. Proposed Project Undetermined cause of Serratia marcescens infections--Multiple States, 2018--New--National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC). Background and Brief Description Serratia marcescens is a Gram-negative bacillus that can be found in the environment and thrives in moist environments. In healthcare settings, it can be found on the hands of healthcare workers and as a contaminant of medical products and devices, particularly aqueous products. It is a known cause of healthcare-associated infections, particularly urinary tract infection, wound infections, and bloodstream infections, and it is an important opportunistic pathogen in neonatal and pediatric intensive care units. Serratia marcescens has been implicated previously in multistate outbreaks of bloodstream infections caused by intrinsic contamination of prefilled syringes of heparin and isotonic sodium chloride solution. On March 27, 2018, the Colorado Department of Public Health and Environment (CDPHE) notified CDC of 4 cases of Serratia marcescens bacteremia among pediatric patients with central lines in an acute care hospital between January 20 and March 23, 2018. This cluster of cases was above the normal baseline of 1-3 cases per year at that facility. The facility examined exposures including common staff and medications and identified commonalities related to the maintenance and care of central lines as well as several medical products including prefilled normal saline syringes and prefilled heparin flushes. On March 28, CDPHE issued a call for cases to other state and local health departments through the Epidemic Information Exchange (Epi-X) system. On March 29, the Tennessee Department of Health (TDH) notified CDC of 3 cases of Serratia marcescens bacteremia in pediatric patients with central lines in a pediatric hospital between March 6 and March 21, 2018; initial examination of medications and common products identified central venous catheter line products as a possible source of infections, including prefilled heparin and normal saline syringes. CDC is currently conducting a multistate investigation to support state health departments. Currently, eight state health departments have reported a total of 26 cases to CDC. However, since more than nine states are ultimately expected to participate, CDC is pursuing emergency OMB clearance to collect patient-level information from ten or more state/local health departments. Most identified patient infections are bloodstream infections, but other body sites (e.g., respiratory) have also been described. Because these events could be linked to a healthcare product (e.g., medical device or pharmaceutical product) with widespread distribution, broad case-finding efforts are needed. Early investigations identified prefilled normal saline syringes and prefilled heparin flushes as common exposures, however healthcare facility records often provide an inadequate basis for identifying the specific product or lot number that was administered to a particular patient, and only facility-level information is available. The products identified in common at this stage of the investigation are widespread in healthcare facilities across the United States and incorrect identification as the source of infections could reasonably be anticipated to create panic in regards to use of these products and limitations in the safe care delivered to thousands of patients. Communications with the Food and Drug Administration (FDA) and product manufacturers indicate a nation-wide shortage of saline following disruption of manufacturing in Puerto Rico during Hurricane Maria in September 2017. FDA has stated that saline shortages in the U.S. mean that alternatives to prefilled saline are limited. In addition, the products are manufactured and subject to Current Good Manufacturing Practice regulations including terminal sterilization of many products using steam sterilization, which reduce opportunities for contamination. This information is essential to the CDC's ability to identify a cause of these events and prevent additional events from occurring. Nationwide case-finding has been implemented through the Epi-X system. The target audience of the case finding will include, but not be limited to, state and local health departments. They will be asked to report any potential cases to CDC. Information on each case will be collected using a data collection form that can be completed online or filled out and returned to CDC. Depending on the nature of each case, CDC may reach out to relevant healthcare facilities or healthcare staff for additional information and recommendation of any prevention measures. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Total burden Type of respondents Form name respondents responses per response (in (in hrs) respondent hrs) ---------------------------------------------------------------------------------------------------------------- Healthcare staff.............. Case finding for 25 2 25/50 100 data collection. --------------------------------------------------------------- Total..................... ................ .............. .............. .............. 100 ---------------------------------------------------------------------------------------------------------------- [[Page 26690]] Jeffrey M. Zirger, Acting Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2018-12372 Filed 6-7-18; 8:45 am] BILLING CODE 4163-18-P
![26688 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices
including awareness and use of the US surveys to private and public sector formatting, usability, and data quality.
MEC, US SPR and QFP; (2) describing family planning providers and clinic OMB approval is requested for one year.
current attitudes and practices among administrators in the United States. The The estimated burden per response for
family planning providers and clinics design, methodology, and analytic providers is 15 minutes and has not
related to recommendations included in approach that CDC plans to implement changed since the previous OMB
the US MEC, US SPR, and QFP and are based on methods previously approval. The estimated burden per
assessing changes from previous data approved for the 2013–2014 survey, response for administrators will be
collections; and (3) identifying training with different instruments being reduced from 40 minutes to 35 minutes.
needs in use of guidance and family administered to providers and clinic The total burden for participants is
planning service delivery (e.g., provider administrators. Minor changes to survey estimated at 1,916 hours. Participation
tools, continuing education modules). content will be made to eliminate
is voluntary and there are no costs to
As in previous phases of data unnecessary questions, add new
respondents other than their time.
collection, CDC plans to administer questions of interest, and improve
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)
Office-based physicians (private sec- 2018–2019 Survey of Health Care 1,000 1 15/60 250
tor). Providers about Family Planning
Attitudes and Practices.
Title X clinic providers (public sector) 2018–2019 Survey of Health Care 1,000 1 15/60 250
Providers about Family Planning
Attitudes and Practices.
Non-Title X publicly funded clinic 2018–2019 Survey of Health Care 1,000 1 15/60 250
providers (public sector). Providers about Family Planning
Attitudes and Practices.
Title X clinic administrators (public 2018–2019 Survey of Administrators 1,000 1 35/60 583
sector). of Health Centers that Provide
Family Planning.
Non-Title X publicly funded clinic ad- 2018–2019 Survey of Administrators 1,000 1 35/60 583
ministrators (public sector). of Health Centers that Provide
Family Planning.
Total ........................................... ........................................................... ........................ ........................ ........................ 1,916
Jeffrey M. Zirger, general public and other Federal Docket Number. CDC will post, without
Acting Chief, Information Collection Review agencies the opportunity to comment on change, all relevant comments to
Office, Office of Scientific Integrity, Office a proposed and/or continuing Regulations.gov.
of the Associate Director for Science, Office information collection, as required by Please note: Submit all comments
of the Director, Centers for Disease Control the Paperwork Reduction Act of 1995. through the Federal eRulemaking portal
and Prevention. This notice invites comment on a (regulations.gov) or by U.S. mail to the
[FR Doc. 2018–12373 Filed 6–7–18; 8:45 am] proposed information collection project address listed above.
BILLING CODE 4163–18–P titled Undetermined cause of Serratia
FOR FURTHER INFORMATION CONTACT: To
marcescens infections—Multiple States,
2018. The goal of this investigation is to request more information on the
DEPARTMENT OF HEALTH AND identify potential risk factors leading to proposed project or to obtain a copy of
HUMAN SERVICES an outbreak of Serratia marcescens the information collection plan and
infections among U.S. healthcare instruments, contact Leroy A.
Centers for Disease Control and Richardson, Information Collection
patients. Data will be used to identify a
Prevention Review Office, Centers for Disease
cause of the infections and prevent
[60Day–18–18ACN; Docket No. CDC–2018– additional events from occurring. Control and Prevention, 1600 Clifton
0042] Road NE, MS–D74, Atlanta, Georgia
DATES: CDC must receive written
30329; phone: 404–639–7570; Email:
comments on or before August 7, 2018.
Proposed Data Collection Submitted omb@cdc.gov.
ADDRESSES: You may submit comments,
for Public Comment and SUPPLEMENTARY INFORMATION: Under the
Recommendations identified by Docket No. CDC–2018–
0042 by any of the following methods: Paperwork Reduction Act of 1995 (PRA)
AGENCY: Centers for Disease Control and • Federal eRulemaking Portal: (44 U.S.C. 3501–3520), Federal agencies
Prevention (CDC), Department of Health Regulations.gov. Follow the instructions must obtain approval from the Office of
and Human Services (HHS). for submitting comments. Management and Budget (OMB) for each
amozie on DSK3GDR082PROD with NOTICES1
ACTION: Notice with comment period. • Mail: Jeffrey M. Zirger, Information collection of information they conduct
Collection Review Office, Centers for or sponsor. In addition, the PRA also
SUMMARY: The Centers for Disease Disease Control and Prevention, 1600 requires Federal agencies to provide a
Control and Prevention (CDC), as part of Clifton Road NE, MS–D74, Atlanta, 60-day notice in the Federal Register
its continuing effort to reduce public Georgia 30329. concerning each proposed collection of
burden and maximize the utility of Instructions: All submissions received information, including each new
government information, invites the must include the agency name and proposed collection, each proposed
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![26690 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices
Jeffrey M. Zirger, e.g., permitting electronic submission of surveys of the injured and exposed fire
Acting Chief, Information Collection Review responses; and fighters identified within NEISS-Work.
Office, Office of Scientific Integrity, Office (e) Assess information collection The proposed telephone interview
of the Associate Director for Science, Office costs.
of the Director, Centers for Disease Control surveys will supplement NEISS-Work
To request additional information on
and Prevention. data with an extensive description of
the proposed project or to obtain a copy
[FR Doc. 2018–12372 Filed 6–7–18; 8:45 am] fire fighter injuries and exposures,
of the information collection plan and
including worker characteristics, injury
BILLING CODE 4163–18–P instruments, call (404) 639–7570 or
types, injury circumstances, injury
send an email to omb@cdc.gov. Direct
outcomes, and use of personal
written comments and/or suggestions
DEPARTMENT OF HEALTH AND protective equipment. Previous reports
regarding the items contained in this
HUMAN SERVICES notice to the Attention: CDC Desk describing occupational injuries and
Officer, Office of Management and exposures to fire fighters provide
Centers for Disease Control and Budget, 725 17th Street NW, limited details on specific regions or
Prevention Washington, DC 20503 or by fax to (202) sub-segments of the population. As
395–5806. Provide written comments compared to these earlier studies, the
[30Day–18–18LQ]
within 30 days of notice publication. scope of the telephone interview data
Agency Forms Undergoing Paperwork will be broader as it includes sampled
Proposed Project cases nationwide and has no limitations
Reduction Act Review
Assessment of Occupational Injury in regards to type of employment (i.e.,
In accordance with the Paperwork among Fire Fighters Using a Follow- volunteer versus career). Results from
Reduction Act of 1995, the Centers for back Survey—New—National Institute the telephone interviews will be
Disease Control and Prevention (CDC) for Occupational Safety and Health weighted and reported as national
has submitted the information (NIOSH), Centers for Disease Control estimates.
collection request titled Assessment of and Prevention (CDC). The sample size for the telephone
Occupational Injury among Fire Fighters
Background and Brief Description interview survey is estimated to be
Using a Follow-back Survey to the
approximately 240 fire fighters annually
Office of Management and Budget Studies have reported that fire fighters
for the proposed three year duration of
(OMB) for review and approval. CDC have high rates of non-fatal injuries and
previously published a ‘‘Proposed Data the study. This is based on the number
illnesses as compared to the general
Collection Submitted for Public of fire fighters identified in previous
worker population. As fire fighters
Comment and Recommendations’’ years of NEISS-Work data and a 30 to
undertake many critical public safety
notice on February 13, 2018 to obtain 40% response rate that is comparable to
activities and are tasked with protecting
comments from the public and affected the rate of previously conducted
the safety and health of the public, it
agencies. CDC received one comment National Electronic Injury Surveillance
follows that understanding and
related to the previous notice. This System telephone interview studies.
preventing injuries and exposures
notice serves to allow an additional 30 among fire fighters will have a benefit Each telephone interview will take
days for public and affected agency reaching beyond the workers to the approximately 30 minutes to complete,
comments. general public. resulting in an annualized burden
CDC will accept all comments for this As mandated in the Occupational estimate of 120 hours. Using the routine
proposed information collection project. Safety and Health Act of 1970 (Pub. L. NEISS-Work data, an analysis of all
The Office of Management and Budget 91–596), the mission of NIOSH is to identified EMS workers will be
is particularly interested in comments conduct research and investigations on performed to determine if there are
that: occupational safety and health. Related differences between the telephone
(a) Evaluate whether the proposed to this mission, the purpose of this interview responder and non-responder
collection of information is necessary project is to conduct research that will groups.
for the proper performance of the provide a detailed description of non- The Division of Safety Research (DSR)
functions of the agency, including fatal occupational injuries and within NIOSH is conducting this
whether the information will have exposures incurred by fire fighters. This project. DSR has a strong interest in
practical utility; information will offer detailed insight improving surveillance of fire fighter
(b) Evaluate the accuracy of the into events that lead to the largest injuries and exposures to provide the
agencies estimate of the burden of the number of nonfatal injuries and information necessary for effectively
proposed collection of information, exposures among fire fighters. The targeting and implementing prevention
including the validity of the project will use two related data efforts and, consequently, reducing
methodology and assumptions used; sources. The first source is data occupational injuries and exposures to
(c) Enhance the quality, utility, and abstracted from medical records of fire fire fighters. The Consumer Product
clarity of the information to be fighters treated in a nationally stratified Safety Commission (CPSC) will also
collected; sample of emergency departments. contribute to this project, as they are
(d) Minimize the burden of the These data are routinely collected responsible for coordinating the
collection of information on those who through the occupational supplement to collection of all NEISS-Work data and
are to respond, including, through the the National Electronic Injury for overseeing the collection of all
amozie on DSK3GDR082PROD with NOTICES1
use of appropriate automated, Surveillance System (NEISS-Work). The telephone interview data. The estimated
electronic, mechanical, or other second data source, for which NIOSH is annual Burden Hours are 120. There is
technological collection techniques or seeking OMB approval for three years, is no cost to respondents other than their
other forms of information technology, responses to telephone interview time.
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Document Created: 2018-06-08 01:22:44
Document Modified: 2018-06-08 01:22:44
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice with comment period. | |
| Dates | CDC must receive written comments on or before August 7, 2018. | |
| Contact | To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected] | |
| FR Citation | 83 FR 26688 |
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