82 FR 60609 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 82, Issue 244 (December 21, 2017)

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 Enhanced Surveillance for Histoplasmosis. CDC will collect state health department and patient furnished histoplasmosis case data.

[Federal Register Volume 82, Number 244 (Thursday, December 21, 2017)]
[Notices]
[Pages 60609-60610]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-27481]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-18EV; Docket No. CDC-2017-0105]


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.

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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 Enhanced Surveillance for 
Histoplasmosis. CDC will collect state health department and patient 
furnished histoplasmosis case data.

DATES: CDC must receive written comments on or before February 20, 
2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0105 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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 Federal 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

[[Page 60610]]

proposed collection, each proposed 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

    Enhanced Surveillance for Histoplasmosis--New--National Center for 
Emerging and Zoonotic Infectious Diseases, 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 was 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 reported 
histoplasmosis cases that meet the CSTE case definition and 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, cases 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 to 300 patient respondents and 15 
minutes for health department personnel to retrieve and record 
diagnostic information from their state reportable disease database. 
This results in an estimated annual burden to the public of 150 hours.

                                        Estimated Annualized Burden Hours
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                                                                            Number of     Average
                                                               Number of    responses    burden per     Total
         Type of respondents                 Form name        respondents      per        response   burden  (in
                                                                            respondent   (in hours)     hours)
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Histoplasmosis cases................  Case Report Form for            300            1        15/60           75
                                       Histoplasmosis
                                       Enhanced Surveillance.
Health department personnel.........  Case Report Form for             10           30        15/60           75
                                       Histoplasmosis
                                       Enhanced Surveillance.
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    Total...........................  ......................  ...........  ...........  ...........          150
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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. 2017-27481 Filed 12-20-17; 8:45 am]
 BILLING CODE 4163-18-P