[Federal Register Volume 83, Number 215 (Tuesday, November 6, 2018)]
[Notices]
[Pages 55549-55551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24231]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-19-18AEJ]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled Natural History of Clostridium difficile
Colonization and Infection to the Office of Management and Budget (OMB)
for review and approval. CDC previously published a ``Proposed Data
Collection Submitted for Public Comment and Recommendations'' notice on
May 29, 2018 to obtain comments from the public and affected agencies.
CDC received one comment related to the previous notice. This notice
serves to allow an additional 30 days for public and affected agency
comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) 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 submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide
written comments within 30 days of notice publication.
[[Page 55550]]
Proposed Project
Natural History of Clostridium difficile Colonization and
Infection--New--National Center for Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
A broad 60-day notice was published in the Federal Register on May
29, 2018, Vol. 83, No. 103, pp. 24475-24476. This 60-day notice
notified the public of the broad agency announcement--Applied Research
to Address Emerging Public Health Priorities--being made by CDC. Though
not specific to this project, it informed the public of CDC's intent to
contract with researchers to carry out a variety of different research
projects.
Current estimates from the CDC suggest that Clostridium difficile
now causes more healthcare-associated infections than any other
pathogen. However, only 10% to 60% of those acquiring colonization with
toxigenic strains develop C. difficile infection (CDI), with the
remainder becoming asymptomatic carriers. Current infection control
measures focus almost entirely on patients with CDI, but several recent
studies suggest that asymptomatic carriers of toxigenic C. difficile
may be an under-appreciated source of transmission. Unfortunately, the
natural history of C. difficile colonization is not well described
because previous studies have not included long-term follow-up of
colonized patients and have not included strain-specific information.
Previous studies of C. difficile carriage have also rarely included
assessments of the burden of carriage, the frequency of skin and
environmental shedding, and the impact of antibiotics and other
healthcare exposures on colonization.
The primary goal of this project is to develop a better
understanding of the natural history of C. difficile colonization and
infection to develop more effective control measures. The study will
answer several questions. How often do patients acquire C. difficile
colonization and shed the organism in their stool? Once colonization is
acquired, how long do patients continue to shed C. difficile in their
stool? How often do patients who acquire C. difficile colonization
develop diarrhea? Are some types of C. difficile strains more likely to
cause diarrhea or more likely to be shed in stool for a long time?
Finally, do factors like antibiotic treatment, other medications, and
diet affect the duration and amount of C. difficile shed in stool?
The results of the study will be used in the design of
interventions to prevent transmission by asymptomatic carriers. The
findings will be valuable for development of accurate transmission
models including estimation of the effects of prevention interventions
and the data will be made available for development of mathematical
models of C. difficile transmission. Finally, the study will provide
current information on the incubation period for CDI and the fraction
of carriers that progress to CDI.
The study hospitals will include the Cleveland VA Medical Center,
MetroHealth Medical Center, and the Medical University of South
Carolina (MUSC). We will conduct a one-year cohort study of 1200 total
patients, including 800 admitted to the hospital, 300 admitted to a
long-term care facility (LTCF), and 100 outpatients with no healthcare
admissions within 3 months. Peri-rectal, groin, chest/abdomen/hand, and
environmental swabs will be collected weekly while in the hospital or
LTCF for up to 4 weeks; for outpatients, swabs will be collected weekly
for up to 4 weeks. Our goal will be to identify patients with new
acquisition of toxigenic C. difficile carriage to study the natural
history of carriage. Based on previous studies, we anticipate that ~12%
of patients will acquire colonization (145 total). For patients with
new acquisition of carriage, additional swabs will be collected up to
once each month for six months to determine the natural history of
colonization and if CDI is diagnosed, stool specimens will be cultured.
One of our goals is to determine the impact of a variety of factors
including antibiotic therapy, medications (e.g., laxatives), diet, and
strain type on duration and burden of C. difficile colonization. In
addition, we will obtain information regarding symptoms of diarrhea. To
obtain this information, we will perform chart review and interviews.
For all subjects, chart review will be conducted during and after
admission to obtain information on demographics, co-morbidities, prior
CDI, ward location, devices, incontinence, bathing practices, proton
pump inhibitor use, mobility, diarrhea, laxatives, and antibiotics
(categorized based upon anti-anaerobic and anti-C. difficile activity).
To supplement information from chart review, subjects will be
interviewed by study personnel at the time of each culture collection
to obtain information on diarrhea, medications including antibiotics,
proton pump inhibitors, and laxatives, diet, bathing practices, and
fecal incontinence.
The information being collected through chart review and interviews
will be valuable to identify factors associated with C. difficile
colonization and infection. If this information were not collected, we
would not be able to adequately assess factors that could affect C.
difficile colonization or infection and/or that could lead to
gastrointestinal symptoms.
To supplement information from chart review, subjects will be
interviewed by study personnel (contractors) at the time of each
culture collection to obtain information on diarrhea, medications
including antibiotics, proton pump inhibitors, and laxatives, diet,
bathing practices, and fecal incontinence. The questions will be
administered by study personnel who will be trained by the principal
investigator or co-investigators. All subjects will be interviewed. The
respondents will have advance notice or appointments.
Total annualized Burden Hours for this study are 577. There is no
burden on respondents other than the time to participate. Authorizing
legislation comes from Section 301 of the Public Health Service Act.
CDC is seeking one year of clearance to complete this study.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Study participants.................... Questionnaire........... 1200 5 5/60
Subjects acquiring C. difficile Questionnaire........... 145 6 5/60
colonization.
Subjects developing CDI............... Questionnaire........... 48 1 5/60
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[[Page 55551]]
Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2018-24231 Filed 11-5-18; 8:45 am]
BILLING CODE 4163-18-P