[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
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                                                                                     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