82_FR_60853 82 FR 60609 - Proposed Data Collection Submitted for Public Comment and Recommendations

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)

Page Range60609-60610
FR Document2017-27481

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 Issue 244 (Thursday, December 21, 2017) 
[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.

-----------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
                                                                            Number of     Average
                                                               Number of    responses    burden per     Total
         Type of respondents                 Form name        respondents      per        response   burden  (in
                                                                            respondent   (in hours)     hours)
----------------------------------------------------------------------------------------------------------------
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.
                                                             ---------------------------------------------------
    Total...........................  ......................  ...........  ...........  ...........          150
----------------------------------------------------------------------------------------------------------------


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

Federal Register / Vol. 82, No. 244 / Thursday, December 21, 2017 / Notices 60609 ESTIMATED ANNUALIZED BURDEN HOURS—Continued Number of Average Total Number of responses burden per Type of respondents Form name burden respondents per response (in hours) respondent (in hours) ABCs Invasive Pneumococcal Disease in Children Case Report 10 22 10/60 37 Form. ABCs Surveillance for Non-Invasive Pneumococcal Pneumonia 10 125 10/60 208 (SNiPP) Case Report Form. ABCs H.influenzae Neonatal Sepsis Expanded Surveillance Form .... 10 6 10/60 10 ABCs Severe GAS Infection Supplemental Form—NEW FORM ........ 10 136 20/60 453 ABCs Neonatal Infection Expanded Tracking Form ............................. 10 37 20/60 123 FoodNet Campylobacter ....................................................................... 10 850 21/60 2,975 FoodNet Cryptosporidium ..................................................................... 10 130 10/60 217 FoodNet Cyclospora ............................................................................. 10 3 10/60 5 FoodNet Listeria monocytogenes ......................................................... 10 13 20/60 43 FoodNet Salmonella ............................................................................. 10 827 21/60 2,895 FoodNet Shiga toxin producing E. coli ................................................. 10 190 20/60 633 FoodNet Shigella .................................................................................. 10 290 10/60 483 FoodNet Vibrio ...................................................................................... 10 25 10/60 42 FoodNet Yersinia .................................................................................. 10 30 10/60 50 FoodNet Hemolytic Uremic Syndrome ................................................. 10 10 1 100 Influenza Hospitalization Surveillance Network Case Report Form ..... 10 1,000 25/60 4,167 Influenza Hospitalization Surveillance Project Vaccination Phone 10 333 5/60 278 Script Consent Form (English). Influenza Hospitalization Surveillance Project Vaccination Phone 10 333 5/60 278 Script Consent Form (Spanish). Influenza Hospitalization Surveillance Project Provider Vaccination 10 333 5/60 278 History Fax Form (Children/Adults). HAIC CDI Case Report Form ............................................................... 10 1,650 30/60 8,250 HAIC Multi-site Gram-Negative Bacilli Case Report Form (MuGSI– 10 500 20/60 1,667 CRE/CRAB). HAIC Multi-site Gram-Negative Bacilli Case Report Form for 10 344 45/60 2,580 Carbapenem-resistant Pseudomonas aeruginosa(CR–PA)—NEW FORM. HAIC Multi-site Gram-Negative Surveillance Initiative—Extended- 10 1,200 20/60 4,000 Spectrum Beta-Lactamase-Producing Enterobacteriaceae (MuGSI– ESBL)—NEW FORM. HAIC Invasive Methicillin-resistant Staphylococcus aureus (MRSA) ... 10 609 20/60 2,030 HAIC Invasive Methicillin-sensitive Staphylococcus aureus (MSSA)— 10 1,035 20/60 3,450 NEW FORM. HAIC Candidemia Case Report Form—NEW FORM .......................... 9 800 20/60 2,400 Total ........................................ ............................................................................................................... .................... .................... .................... 40,347 Leroy A. Richardson, burden and maximize the utility of Docket Number. CDC will post, without Chief, Information Collection Review Office, government information, invites the change, all relevant comments to Office of Scientific Integrity, Office of the general public and other Federal Regulations.gov. Associate Director for Science, Office of the agencies the opportunity to comment on Please note: Submit all Federal Director, Centers for Disease Control and a proposed and/or continuing comments through the Federal Prevention. information collection, as required by eRulemaking portal (regulations.gov) or [FR Doc. 2017–27482 Filed 12–20–17; 8:45 am] the Paperwork Reduction Act of 1995. by U.S. mail to the address listed above. BILLING CODE 4163–18–P This notice invites comment on a FOR FURTHER INFORMATION CONTACT: To proposed information collection project request more information on the titled Enhanced Surveillance for proposed project or to obtain a copy of DEPARTMENT OF HEALTH AND Histoplasmosis. CDC will collect state the information collection plan and HUMAN SERVICES health department and patient furnished instruments, contact Leroy A. Centers for Disease Control and histoplasmosis case data. Richardson, Information Collection Prevention DATES: CDC must receive written Review Office, Centers for Disease comments on or before February 20, Control and Prevention, 1600 Clifton [60Day–18–18EV; Docket No. CDC–2017– 2018. Road NE, MS–D74, Atlanta, Georgia 0105] 30329; phone: 404–639–7570; Email: ADDRESSES: You may submit comments, identified by Docket No. CDC–2017– omb@cdc.gov. Proposed Data Collection Submitted 0105 by any of the following methods: SUPPLEMENTARY INFORMATION: Under the for Public Comment and Recommendations • Federal eRulemaking Portal: Paperwork Reduction Act of 1995 (PRA) Regulations.gov. Follow the instructions (44 U.S.C. 3501–3520), Federal agencies AGENCY: Centers for Disease Control and for submitting comments. must obtain approval from the Office of daltland on DSKBBV9HB2PROD with NOTICES Prevention (CDC), Department of Health • Mail: Leroy A. Richardson, Management and Budget (OMB) for each and Human Services (HHS). Information Collection Review Office, collection of information they conduct ACTION: Notice with comment period. Centers for Disease Control and or sponsor. In addition, the PRA also Prevention, 1600 Clifton Road NE, MS– requires Federal agencies to provide a SUMMARY: The Centers for Disease D74, Atlanta, Georgia 30329. 60-day notice in the Federal Register Control and Prevention (CDC), as part of Instructions: All submissions received concerning each proposed collection of its continuing effort to reduce public must include the agency name and information, including each new VerDate Sep<11>2014 20:57 Dec 20, 2017 Jkt 244001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\21DEN1.SGM 21DEN1

60610 Federal Register / Vol. 82, No. 244 / Thursday, December 21, 2017 / Notices proposed collection, each proposed Background and Brief Description decreased productivity), understand extension of existing collection of Histoplasmosis is an infectious patient awareness of histoplasmosis, information, and each reinstatement of disease caused by inhalation of the and determine its true public health previously approved information environmental fungus Histoplasma burden. This information will not only collection before submitting the capsulatum. Histoplasmosis can range help inform routine surveillance collection to the OMB for approval. To from asymptomatic or mild illness to practices, but also guide awareness comply with this requirement, we are severe disseminated disease, and it is efforts and appropriate prevention publishing this notice of a proposed often described as the most common strategies. data collection as described below. endemic mycosis in North America. The OMB is particularly interested in For a period of one year, health However, much still remains unknown department personnel in participating comments that will help: about the epidemiology and patient 1. Evaluate whether the proposed states will conduct telephone interviews burden of histoplasmosis in the United with reported histoplasmosis cases that collection of information is necessary States. Histoplasmosis is currently for the proper performance of the meet the CSTE case definition and will reportable in 11 states but is not functions of the agency, including record responses on a standardized nationally notifiable. In June 2016, the whether the information will have form. The form will collect information Council of State and Territorial practical utility; on demographics, underlying medical Epidemiologists (CSTE) passed a 2. Evaluate the accuracy of the conditions, exposures, symptom type position statement to standardize the agency’s estimate of the burden of the and duration, healthcare-seeking case definition for histoplasmosis, a first proposed collection of information, behaviors, diagnosis, treatment, and step towards more consistent including the validity of the outcomes. methodology and assumptions used; surveillance methodology. A recent 3. Enhance the quality, utility, and multistate analysis of histoplasmosis This interview activity is consistent clarity of the information to be cases reported to public health during with the state’s existing authority to collected; and 2011–2014 also revealed variation in the investigate reports of notifiable diseases 4. Minimize the burden of the data elements collected by each state, for routine surveillance purposes; collection of information on those who limiting inter-state comparability. In therefore, formal consent to participate are to respond, including through the addition, data on possible exposures, in the surveillance is not required. use of appropriate automated, underlying medical conditions, However, cases may choose not to electronic, mechanical, or other symptoms, and antifungal treatment was participate and may choose not to technological collection techniques or only collected in a few states. answer any question they do not wish other forms of information technology, Furthermore, no multistate data exists to answer. e.g., permitting electronic submissions about histoplasmosis cases identified using the newly-created CSTE case It will take health department of responses. 5. Assess information collection costs. definition. personnel approximately 15 minutes to More detailed data about administer the questionnaire to 300 Proposed Project histoplasmosis cases detected during patient respondents and 15 minutes for Enhanced Surveillance for routine surveillance are needed to better health department personnel to retrieve Histoplasmosis—New—National Center understand the features of persons at and record diagnostic information from for Emerging and Zoonotic Infectious risk, characterize the effects of their state reportable disease database. Diseases, Centers for Disease Control histoplasmosis on patients (e.g., delays This results in an estimated annual and Prevention (CDC). in diagnosis, symptom duration, and burden to the public of 150 hours. ESTIMATED ANNUALIZED BURDEN HOURS Number of Average Total Number of responses burden per Type of respondents Form name burden respondents per response (in hours) respondent (in hours) Histoplasmosis cases ........................... Case Report Form for Histoplasmosis Enhanced Surveillance .... 300 1 15/60 75 Health department personnel ............... Case Report Form for Histoplasmosis Enhanced Surveillance .... 10 30 15/60 75 Total .............................................. ......................................................................................................... .................... .................... .................... 150 Leroy A. Richardson, DEPARTMENT OF HEALTH AND erroneous re-publication of a notice Chief, Information Collection Review Office, HUMAN SERVICES published on 10/20/2017 at vol. 82, Office of Scientific Integrity, Office of the page 48821. No additional comments Associate Director for Science, Office of the Administration for Children and are being solicited at this time. We Director, Centers for Disease Control and Families regret the confusion it may have caused. Prevention. [FR Doc. 2017–27481 Filed 12–20–17; 8:45 am] Correction to Notice Published Robert Sargis, BILLING CODE 4163–18–P 12/13/2017 Reports Clearance Officer. daltland on DSKBBV9HB2PROD with NOTICES [FR Doc. 2017–27479 Filed 12–20–17; 8:45 am] Title: Adoption and Foster Care Analysis Reporting System for title IV– BILLING CODE 4184–01–P B and title IV–E (AFCARS). OMB No.: 0970–0422. Description: The notice, vol. 82, page 58615, published 12/13/2017 was an VerDate Sep<11>2014 20:57 Dec 20, 2017 Jkt 244001 PO 00000 Frm 00033 Fmt 4703 Sfmt 9990 E:\FR\FM\21DEN1.SGM 21DEN1


Document Created: 2018-10-25 11:00:04
Document Modified: 2018-10-25 11:00:04
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
ActionNotice with comment period.
DatesCDC must receive written comments on or before February 20, 2018.
ContactTo 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]
FR Citation82 FR 60609 
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