83_FR_10532 83 FR 10485 - Agency Forms Undergoing Paperwork Reduction Act Review

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)

Page Range10485-10486
FR Document2018-04741

Federal Register, Volume 83 Issue 47 (Friday, 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 omb@cdc.gov. 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

Federal Register / Vol. 83, No. 47 / Friday, March 9, 2018 / Notices 10485 Biological Agents, Infectious Substances government agencies, universities, and for educational, exhibition or scientific and Vectors of Human Disease into the research institutions to request a permit purposes to request a permit for the United States’’ form fillable so that for the importation of biological agents, importation, and any subsequent applicants are able to complete the infectious substances, or vectors of distribution after importation, of live electronically. We made no changes human disease. This form has been bats. This form currently requests the based on this comment but note that the revised to remove questions that are applicant and sender contact form will be published as a pdf-fillable duplicative or not required to process information; a description and intended form so that applicants have the ability the import permit request and added use of bats to be imported; and facility to save the document to the applicant’s questions requesting biosafety officer’s isolation and containment information. local drive, complete the form, and then contact information and verifying CDC revised this application to add a mail or fax the application to CDC. The biosafety measures for any subsequent question about what personal protective other two comments did not pertain to transfers listed on the import permit the changes to the forms. Therefore, we application of infectious biological measures will be used. made no changes to forms based on agent, infectious substance, and/or Estimates of burden for the survey are these comments. vector once in the United States. based on information obtained from the The Application for Permit to Import The Application for Permit to Import CDC import permit database on the Biological Agents, Infectious Substances or Transport Live Bats form is used by number of permits issued on annual and Vectors of Human Disease into the laboratory facilities such as those basis since 2010. CDC estimates 1,322 United States form is used by laboratory operated by government agencies, burden hours for this collection. facilities, such as those operated by universities, research institutions, and ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Type of respondent Form name responses per respondents response respondent (in hours) Applicants Requesting to Import Biological Application for Permit to Import Biological 2,000 1 20/60 Agents, Infectious Substances and Vectors. Agents, Infectious Substances and Vectors of Human Disease into the United States. Applicants Requesting to Import Biological Application for Permit to Import Biological 2,000 1 10/60 Agents, Infectious Substances and Vectors. Agents, Infectious Substances and Vectors of Human Disease into the United States Guidance. Applicants Requesting to Import Biological Application for Permit to Import Biological 380 1 50/60 Agents, Infectious Substances and Vectors. Agents, Infectious Substances and Vectors of Human Disease into the United States- Subsequent Transfer. Applicants Requesting to Import Live Bats .... Application for a Permit to Import Live Bats .. 10 1 20/60 Applicants Requesting to Import Live Bats .... Application for a Permit to Import Live Bats 10 1 10/60 Guidance. Leroy A. Richardson, (OMB) for review and approval. CDC (c) Enhance the quality, utility, and Chief, Information Collection Review Office, previously published a ‘‘Proposed Data clarity of the information to be Office of Scientific Integrity, Office of the Collection Submitted for Public collected; Associate Director for Science, Office of the Comment and Recommendations’’ (d) Minimize the burden of the Director, Centers for Disease Control and notice on December 21, 2017 to obtain collection of information on those who Prevention. comments from the public and affected are to respond, including, through the [FR Doc. 2018–04742 Filed 3–8–18; 8:45 am] agencies. CDC did not receive comments use of appropriate automated, BILLING CODE 4163–18–P related to the previous notice. This electronic, mechanical, or other notice serves to allow an additional 30 technological collection techniques or days for public and affected agency other forms of information technology, DEPARTMENT OF HEALTH AND comments. e.g., permitting electronic submission of HUMAN SERVICES CDC will accept all comments for this responses; and proposed information collection project. (e) Assess information collection Centers for Disease Control and The Office of Management and Budget costs. Prevention is particularly interested in comments To request additional information on that: the proposed project or to obtain a copy [30Day–18–18EV] (a) Evaluate whether the proposed of the information collection plan and Agency Forms Undergoing Paperwork collection of information is necessary instruments, call (404) 639–7570 or Reduction Act Review for the proper performance of the send an email to omb@cdc.gov. Direct functions of the agency, including written comments and/or suggestions amozie on DSK30RV082PROD with NOTICES In accordance with the Paperwork whether the information will have regarding the items contained in this Reduction Act of 1995, the Centers for practical utility; notice to the Attention: CDC Desk Disease Control and Prevention (CDC) (b) Evaluate the accuracy of the Officer, Office of Management and has submitted the information agencies estimate of the burden of the Budget, 725 17th Street NW, collection request titled Enhanced proposed collection of information, Washington, DC 20503 or by fax to (202) Surveillance for Histoplasmosis to the including the validity of the 395–5806. Provide written comments Office of Management and Budget methodology and assumptions used; within 30 days of notice publication. VerDate Sep<11>2014 16:47 Mar 08, 2018 Jkt 244001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1

10486 Federal Register / Vol. 83, No. 47 / Friday, March 9, 2018 / Notices Proposed Project limiting inter-state comparability. In demographics, underlying medical Enhanced Surveillance for addition, data on possible exposures, conditions, exposures, symptom type Histoplasmosis—New—National Center underlying medical conditions, and duration, healthcare-seeking for Emerging and Zoonotic Infectious symptoms, and antifungal treatment behaviors, diagnosis, treatment, and Diseases (NCEZID), Centers for Disease were only collected in a few states. outcomes. Control and Prevention (CDC). Furthermore, no multistate data exists This interview activity is consistent about histoplasmosis cases identified with the state’s existing authority to Background and Brief Description using the newly-created CSTE case investigate reports of notifiable diseases Histoplasmosis is an infectious definition. for routine surveillance purposes; disease caused by inhalation of the More detailed data about therefore, formal consent to participate environmental fungus Histoplasma histoplasmosis cases detected during in the surveillance is not required. capsulatum. Histoplasmosis can range routine surveillance are needed to better However, individuals may choose not to from asymptomatic or mild illness to understand the features of persons at participate and may choose not to severe disseminated disease, and it is risk, characterize the effects of answer any question they do not wish often described as the most common histoplasmosis on patients (e.g., delays to answer. endemic mycosis in North America. in diagnosis, symptom duration, and decreased productivity), understand It will take health department However, much still remains unknown patient awareness of histoplasmosis, personnel approximately 15 minutes to about the epidemiology and patient and determine its true public health administer the questionnaire and 15 burden of histoplasmosis in the United burden. This information will not only minutes to retrieve and record States. Histoplasmosis is currently reportable help inform routine surveillance diagnostic information from their state in 11 states but is not nationally practices, but also guide awareness reportable disease database. For an notifiable. In June 2016, the Council of efforts and appropriate prevention estimated 300 patient respondents and State and Territorial Epidemiologists strategies. 10 public health respondents, this (CSTE) passed a position statement to For a period of one year, health results in an estimated annual burden to standardize the case definition for department personnel in participating the public of 150 hours. There are no histoplasmosis, a first step towards states will conduct telephone interviews additional costs to respondents other more consistent surveillance with individuals reported as than their time. methodology. A recent multistate histoplasmosis cases and that meet the This is a new Information Collection analysis of histoplasmosis cases CSTE case definition. Health Request. CDC seeks a 24-month reported to public health during 2011– department personnel will record approval. This study is authorized 2014 also revealed variation in the data responses on a standardized form. The under Section 301 of the Public Health elements collected by each state, form will collect information on Service Act (42 U.S.C. 241). ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Type of respondents Form name responses per respondents response respondent (in hours) Histoplasmosis cases ..................................... Case Report Form for Histoplasmosis En- 300 1 15/60 hanced Surveillance. Health Department Personnel ........................ Case Report Form for Histoplasmosis En- 10 30 15/60 hanced Surveillance. Leroy A. Richardson, Families (ACF), Department of Health changes-to-the-pir-for-public- Chief, Information Collection Review Office, and Human Services (HHS). comment.pdf. Office of Scientific Integrity, Office of the Associate Director for Science, Office of the ACTION:Request for public comments on DATES: Submit comments by April 6, Director, Centers for Disease Control and Head Start Program Information Report. 2018. Prevention. [FR Doc. 2018–04741 Filed 3–8–18; 8:45 am] SUMMARY: The Office of Head Start FOR FURTHER INFORMATION CONTACT: Fran BILLING CODE 4163–18–P invites public comment on several Majestic, Division Director of Program major changes to the Head Start Program Operations Division, HeadStart@ Information Report (PIR) to better align eclkc.info, 1–866–763–648. Deaf and DEPARTMENT OF HEALTH AND with the comprehensive revision of the hearing-impaired individuals may call HUMAN SERVICES the Federal Dual Party Relay Service at Head Start Program Performance Standards (HSPPS), reduce reporting 1–800–877–8339 between 8 a.m. and 7 Administration for Children and burden, and improve the data p.m. Eastern Standard Time. Families collection. Major changes include amozie on DSK30RV082PROD with NOTICES Dated: February 28, 2018. RIN 0970–0427 proposals to remove, add, and Ann Linehan, significantly update PIR questions. To Request for Public Comments on Head Acting Director, Office of Head Start. view proposed changes to the PIR to go Start Program Information Report [FR Doc. 2018–04683 Filed 3–8–18; 8:45 am] into effect for the 2019–20 PIR, please BILLING CODE 4184–40–P AGENCY:Office of Head Start (OHS), visit https://eclkc.ohs.acf.hhs.gov/sites/ Administration for Children and default/files/pdf/summary-of-proposed- VerDate Sep<11>2014 16:47 Mar 08, 2018 Jkt 244001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1


Document Created: 2018-03-09 03:48:08
Document Modified: 2018-03-09 03:48:08
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation83 FR 10485 
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