83 FR 10485 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 47 (March 9, 2018)

[Federal Register Volume 83, Number 47 (Friday, March 9, 2018)]
[Notices]
[Pages 10485-10486]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-04741]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-18EV]


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 
(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 10486]]

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


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.
[FR Doc. 2018-04741 Filed 3-8-18; 8:45 am]
 BILLING CODE 4163-18-P