81_FR_40820 81 FR 40700 - Proposed Data Collection Submitted for Public Comment and Recommendations

81 FR 40700 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 81, Issue 120 (June 22, 2016)

Page Range40700-40701
FR Document2016-14727

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on Using the Standardized National Hypothesis Generating Questionnaire during Multistate Investigations of Foodborne Disease Clusters and Outbreaks.

Federal Register, Volume 81 Issue 120 (Wednesday, June 22, 2016) 
[Federal Register Volume 81, Number 120 (Wednesday, June 22, 2016)]
[Notices]
[Pages 40700-40701]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-14727]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-0997; Docket No. CDC-2016-0054]


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 efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on Using the 
Standardized National Hypothesis Generating Questionnaire during 
Multistate Investigations of Foodborne Disease Clusters and Outbreaks.

DATES: Written comments must be received on or before August 22, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0054 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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note:  All public comment should be submitted 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 the 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 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    Standardized National Hypothesis Generating Questionnaire (0920-
0997, Expiration Date 10/31/2016)--Revision--National Center for 
Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    It is estimated that each year roughly 1 in 6 Americans gets sick, 
128,000 are hospitalized, and 3,000 die of foodborne diseases. CDC and 
partners ensure rapid and coordinated surveillance, detection, and 
response to multistate outbreaks, to limit the number of illnesses, and 
to learn how to prevent similar outbreaks from happening in the future.
    Conducting interviews during the initial hypothesis-generating 
phase of multistate foodborne disease outbreaks presents numerous 
challenges. In the U.S. there is not a standard, national form or data 
collection system for illnesses caused by many enteric

[[Page 40701]]

pathogens. Data elements for hypothesis generation must be developed 
and agreed upon for each investigation. This process can take several 
days to weeks and may cause interviews to occur long after a person 
becomes ill.
    CDC requests a revision to this project to collect standardized 
information, called the Standardized National Hypothesis-Generating 
Questionnaire, from individuals who have become ill during a multistate 
foodborne disease event. Since the questionnaire is designed to be 
administered by public health officials as part of multistate 
hypothesis-generating interview activities, this questionnaire is not 
expected to entail significant burden to respondents.
    The Standardized National Hypothesis-Generating Core Elements 
Project was established with the goal to define a core set of data 
elements to be used for hypothesis generation during multistate 
foodborne investigations. These elements represent the minimum set of 
information that should be available for all outbreak-associated cases 
identified during hypothesis generation. The core elements would ensure 
that similar exposures would be ascertained across many jurisdictions, 
allowing for rapid pooling of data to improve the timeliness of 
hypothesis-generating analyses and shorten the time to pinpoint how and 
where contamination events occur.
    The Standardized National Hypothesis Generating Questionnaire was 
designed as a data collection tool for the core elements, to be used 
when a multistate cluster of enteric disease infections is identified. 
The questionnaire is designed to be administered over the phone by 
public health officials to collect core elements data from case-
patients or their proxies. Both the content of the questionnaire (the 
core elements) and the format were developed through a series of 
working groups comprised of local, state, and federal public health 
partners.
    Since implementation of the SNHGQ in 2013, ORPB has investigated 
over 700 multistate foodborne and enteric clusters of infection 
involving over 26,000 ill people. Of which, an outbreak vehicle has 
been identified in 200 of these investigations. These outbreaks have 
led to over 50 recalls and countless regulatory actions that have 
removed millions of pounds of contaminated vehicles out of commerce. In 
almost all instances, the SNHGQ or iterations of the SNHGQ have been 
instrumental in the successful investigation of these outbreaks. The 
questionnaire has allowed investigators to more efficiently and 
effectively interview ill persons as they are identified. Because these 
exposures are captured in a common, standard format, we have been able 
to share and analyze data rapidly across jurisdictional lines. Faster 
interview response and analysis times have allowed for more rapid 
epidemiologic investigation and quicker regulatory action, thus helping 
to prevent thousands of additional illnesses from occurring and 
spurring industry to adopt and implement new food safety measures in an 
effort to prevent future outbreaks.
    The total estimated annualized burden for the Standardized National 
Generating Questionnaire is 3,000 hours (approximately 4,000 
individuals identified during the hypothesis-generating phase of 
outbreak investigations with 45 minutes/response).
    There are no costs to respondents other than their time.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total burden
              Type of respondents                               Form name                   respondents    responses per   response (in      (in hrs)
                                                                                                            respondent         hrs)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Individuals....................................  Standardized National Hypothesis                  4,000               1           45/60           3,000
                                                  Generating Questionnaire (Core
                                                  Elements).
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............           3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------


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. 2016-14727 Filed 6-21-16; 8:45 am]
 BILLING CODE 4163-18-P

40700 Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Notices ESTIMATED ANNUAL REPORTING BURDEN Average Number of Number of burden per Total burden Type of respondent Form name responses per respondents response hours respondent (in hours) Adult Poison Center Callers ............. Call-back Questionnaire for Self ...... 210 1 40/60 140 Adolescent Poison Center Callers .... Call-back Questionnaire for Self ...... 30 1 40/60 20 Parent or Guardian Poison Center Call-back Questionnaire for Proxy ... 60 1 40/60 40 Callers. Total ........................................... ........................................................... ........................ ........................ ........................ 200 Leroy A. Richardson, Prevention, 1600 Clifton Road NE., MS– clarity of the information to be Chief, Information Collection Review Office, D74, Atlanta, Georgia 30329. collected; (d) ways to minimize the Office of Scientific Integrity, Office of the Instructions: All submissions received burden of the collection of information Associate Director for Science, Office of the must include the agency name and on respondents, including through the Director, Centers for Disease Control and Docket Number. All relevant comments use of automated collection techniques Prevention. received will be posted without change or other forms of information [FR Doc. 2016–14726 Filed 6–21–16; 8:45 am] to Regulations.gov, including any technology; and (e) estimates of capital BILLING CODE 4163–18–P personal information provided. For or start-up costs and costs of operation, access to the docket to read background maintenance, and purchase of services documents or comments received, go to to provide information. Burden means DEPARTMENT OF HEALTH AND Regulations.gov. the total time, effort, or financial HUMAN SERVICES resources expended by persons to Please note: All public comment should be submitted through the Federal eRulemaking generate, maintain, retain, disclose or Centers for Disease Control and provide information to or for a Federal portal (Regulations.gov) or by U.S. mail to the Prevention address listed above. agency. This includes the time needed to review instructions; to develop, [60Day–16–0997; Docket No. CDC–2016– FOR FURTHER INFORMATION CONTACT: To acquire, install and utilize technology 0054] request more information on the and systems for the purpose of proposed project or to obtain a copy of collecting, validating and verifying Proposed Data Collection Submitted the information collection plan and information, processing and for Public Comment and instruments, contact the Information maintaining information, and disclosing Recommendations Collection Review Office, Centers for and providing information; to train Disease Control and Prevention, 1600 AGENCY: Centers for Disease Control and personnel and to be able to respond to Clifton Road NE., MS–D74, Atlanta, Prevention (CDC), Department of Health a collection of information, to search Georgia 30329; phone: 404–639–7570; and Human Services (HHS). data sources, to complete and review Email: omb@cdc.gov. ACTION: Notice with comment period. the collection of information; and to SUPPLEMENTARY INFORMATION: Under the transmit or otherwise disclose the Paperwork Reduction Act of 1995 (PRA) information. SUMMARY: The Centers for Disease (44 U.S.C. 3501–3520), Federal agencies Control and Prevention (CDC), as part of Proposed Project must obtain approval from the Office of its continuing efforts to reduce public Management and Budget (OMB) for each Standardized National Hypothesis burden and maximize the utility of collection of information they conduct Generating Questionnaire (0920–0997, government information, invites the or sponsor. In addition, the PRA also Expiration Date 10/31/2016)— general public and other Federal requires Federal agencies to provide a Revision—National Center for Emerging agencies to take this opportunity to 60-day notice in the Federal Register and Zoonotic Infectious Diseases comment on proposed and/or concerning each proposed collection of (NCEZID), Centers for Disease Control continuing information collections, as information, including each new and Prevention (CDC). required by the Paperwork Reduction proposed collection, each proposed Act of 1995. This notice invites Background and Brief Description extension of existing collection of comment on Using the Standardized information, and each reinstatement of It is estimated that each year roughly National Hypothesis Generating previously approved information 1 in 6 Americans gets sick, 128,000 are Questionnaire during Multistate collection before submitting the hospitalized, and 3,000 die of foodborne Investigations of Foodborne Disease collection to OMB for approval. To diseases. CDC and partners ensure rapid Clusters and Outbreaks. comply with this requirement, we are and coordinated surveillance, detection, DATES: Written comments must be publishing this notice of a proposed and response to multistate outbreaks, to received on or before August 22, 2016. data collection as described below. limit the number of illnesses, and to ADDRESSES: You may submit comments, Comments are invited on: (a) Whether learn how to prevent similar outbreaks identified by Docket No. CDC–2016– the proposed collection of information from happening in the future. mstockstill on DSK3G9T082PROD with NOTICES 0054 by any of the following methods: is necessary for the proper performance Conducting interviews during the • Federal eRulemaking Portal: of the functions of the agency, including initial hypothesis-generating phase of Regulations.gov. Follow the instructions whether the information shall have multistate foodborne disease outbreaks for submitting comments. practical utility; (b) the accuracy of the presents numerous challenges. In the • Mail: Leroy A. Richardson, agency’s estimate of the burden of the U.S. there is not a standard, national Information Collection Review Office, proposed collection of information; (c) form or data collection system for Centers for Disease Control and ways to enhance the quality, utility, and illnesses caused by many enteric VerDate Sep<11>2014 20:02 Jun 21, 2016 Jkt 238001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\22JNN1.SGM 22JNN1

Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Notices 40701 pathogens. Data elements for hypothesis ascertained across many jurisdictions, vehicles out of commerce. In almost all generation must be developed and allowing for rapid pooling of data to instances, the SNHGQ or iterations of agreed upon for each investigation. This improve the timeliness of hypothesis- the SNHGQ have been instrumental in process can take several days to weeks generating analyses and shorten the the successful investigation of these and may cause interviews to occur long time to pinpoint how and where outbreaks. The questionnaire has after a person becomes ill. contamination events occur. allowed investigators to more efficiently CDC requests a revision to this project The Standardized National and effectively interview ill persons as to collect standardized information, Hypothesis Generating Questionnaire they are identified. Because these called the Standardized National was designed as a data collection tool exposures are captured in a common, Hypothesis-Generating Questionnaire, for the core elements, to be used when standard format, we have been able to from individuals who have become ill a multistate cluster of enteric disease share and analyze data rapidly across during a multistate foodborne disease infections is identified. The jurisdictional lines. Faster interview event. Since the questionnaire is questionnaire is designed to be response and analysis times have designed to be administered by public administered over the phone by public allowed for more rapid epidemiologic health officials as part of multistate health officials to collect core elements investigation and quicker regulatory hypothesis-generating interview data from case-patients or their proxies. action, thus helping to prevent activities, this questionnaire is not Both the content of the questionnaire thousands of additional illnesses from expected to entail significant burden to (the core elements) and the format were occurring and spurring industry to respondents. developed through a series of working adopt and implement new food safety The Standardized National groups comprised of local, state, and measures in an effort to prevent future Hypothesis-Generating Core Elements federal public health partners. outbreaks. Project was established with the goal to Since implementation of the SNHGQ The total estimated annualized define a core set of data elements to be in 2013, ORPB has investigated over 700 burden for the Standardized National used for hypothesis generation during multistate foodborne and enteric Generating Questionnaire is 3,000 hours multistate foodborne investigations. clusters of infection involving over (approximately 4,000 individuals These elements represent the minimum 26,000 ill people. Of which, an outbreak identified during the hypothesis- set of information that should be vehicle has been identified in 200 of generating phase of outbreak available for all outbreak-associated these investigations. These outbreaks investigations with 45 minutes/ cases identified during hypothesis have led to over 50 recalls and countless response). generation. The core elements would regulatory actions that have removed There are no costs to respondents ensure that similar exposures would be millions of pounds of contaminated other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Total burden Type of respondents Form name responses per respondents response (in hrs) respondent (in hrs) Individuals .................................. Standardized National Hypothesis Gen- 4,000 1 45/60 3,000 erating Questionnaire (Core Elements). Total .................................... ................................................................. ........................ ........................ ........................ 3,000 Leroy A. Richardson, Matters for Discussion: The agenda meetings and other committee Chief, Information Collection Review Office, will include discussions on management activities for both the Office of Scientific Integrity, Office of the meningococcal vaccines; human Centers for Disease Control and Associate Director for Science, Office of the papillomavirus vaccines; influenza; Prevention and the Agency for Toxic Director, Centers for Disease Control and cholera vaccine; hepatitis vaccines; Substances and Disease Registry. Prevention. safety of maternal Tdap vaccination; [FR Doc. 2016–14727 Filed 6–21–16; 8:45 am] Respiratory Syncytial Virus (RSV) and Elaine L. Baker, BILLING CODE 4163–18–P vaccine supply. A recommendation vote Director, Management Analysis and Services is scheduled for meningococcal Office Centers for Disease Control and vaccines, influenza vaccine, and cholera Prevention. DEPARTMENT OF HEALTH AND vaccine. A VFC vote is scheduled for [FR Doc. 2016–14787 Filed 6–21–16; 8:45 am] HUMAN SERVICES meningococcal vaccines, and influenza. BILLING CODE 4160–18–P Agenda items are subject to change as Centers for Disease Control and priorities dictate. Prevention Contact Person for More Information: Advisory Committee on Immunization Stephanie Thomas, National Center for Immunization and Respiratory Diseases, mstockstill on DSK3G9T082PROD with NOTICES Practices (ACIP) CDC, 1600 Clifton Road NE., MS–A27, Amendment: A notice of this meeting Atlanta, Georgia 30329, telephone 404/ was published in the Federal Register 639–8836; Email ACIP@CDC.GOV. on May 24, 2016, Volume 81, Number The Director, Management Analysis 100, Pages 32754–32755. The original and Services Office, has been delegated notice is amended to include Matters for the authority to sign Federal Register Discussion as follows: notices pertaining to announcements of VerDate Sep<11>2014 20:02 Jun 21, 2016 Jkt 238001 PO 00000 Frm 00049 Fmt 4703 Sfmt 9990 E:\FR\FM\22JNN1.SGM 22JNN1


Document Created: 2016-06-22 01:06:29
Document Modified: 2016-06-22 01:06:29
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.
DatesWritten comments must be received on or before August 22, 2016.
ContactTo request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the 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 Citation81 FR 40700 
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