2018-04741. 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 Enhanced Surveillance for Histoplasmosis 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 December 21, 2017 to obtain comments from the public and affected agencies. CDC did not receive comments 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 [phone] or send an email to [e-mail]. 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 [phone]. Provide written comments within 30 days of notice publication.

Proposed Project

Enhanced Surveillance for Histoplasmosis—New—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Histoplasmosis is an infectious disease caused by inhalation of the environmental fungus Histoplasma capsulatum. Histoplasmosis can range from asymptomatic or mild illness to severe disseminated disease, and it is often described as the most common endemic mycosis in North America. However, much still remains unknown about the epidemiology and patient burden of histoplasmosis in the United States.

Histoplasmosis is currently reportable in 11 states but is not nationally notifiable. In June 2016, the Council of State and Territorial Epidemiologists (CSTE) passed a position statement to standardize the case definition for histoplasmosis, a first step towards more consistent surveillance methodology. A recent multistate analysis of histoplasmosis cases reported to public health during 2011-2014 also revealed variation in the data elements collected by each state, limiting inter-state comparability. In addition, data on possible exposures, underlying medical conditions, symptoms, and antifungal treatment were only collected in a few states. Furthermore, no multistate data exists about histoplasmosis cases identified using the newly-created CSTE case definition.

More detailed data about histoplasmosis cases detected during routine surveillance are needed to better understand the features of persons at risk, characterize the effects of histoplasmosis on patients (e.g., delays in diagnosis, symptom duration, and decreased productivity), understand patient awareness of histoplasmosis, and determine its true public health burden. This information will not only help inform routine surveillance practices, but also guide awareness efforts and appropriate prevention strategies.

For a period of one year, health department personnel in participating states will conduct telephone interviews with individuals reported as histoplasmosis cases and that meet the CSTE case definition. Health department personnel will record responses on a standardized form. The form will collect information on demographics, underlying medical conditions, exposures, symptom type and duration, healthcare-seeking behaviors, diagnosis, treatment, and outcomes.

This interview activity is consistent with the state's existing authority to investigate reports of notifiable diseases for routine surveillance purposes; therefore, formal consent to participate in the surveillance is not required. However, individuals may choose not to participate and may choose not to answer any question they do not wish to answer.

It will take health department personnel approximately 15 minutes to administer the questionnaire and 15 minutes to retrieve and record diagnostic information from their state reportable disease database. For an estimated 300 patient respondents and 10 public health respondents, this results in an estimated annual burden to the public of 150 hours. There are no additional costs to respondents other than their time.

This is a new Information Collection Request. CDC seeks a 24-month approval. This study is authorized under Section 301 of the Public Health Service Act (42 U.S.C. 241).

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Histoplasmosis cases	Case Report Form for Histoplasmosis Enhanced Surveillance	300	1	15/60
Health Department Personnel	Case Report Form for Histoplasmosis Enhanced Surveillance	10	30	15/60

Leroy A. Richardson,

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.