82_FR_18534 82 FR 18460 - Proposed Data Collection Submitted for Public Comment and Recommendations

82 FR 18460 - 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 74 (April 19, 2017)

Page Range18460-18462
FR Document2017-07880

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 a proposed information collection project titled ``Zika Postpartum Emergency Response Survey (ZPER), Puerto Rico, 2017.''

Federal Register, Volume 82 Issue 74 (Wednesday, April 19, 2017) 
[Federal Register Volume 82, Number 74 (Wednesday, April 19, 2017)]
[Notices]
[Pages 18460-18462]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-07880]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-17ABC; Docket No. CDC-2017-0033]


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 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 a proposed 
information collection project titled ``Zika Postpartum Emergency 
Response Survey (ZPER), Puerto Rico, 2017.''

DATES: Written comments must be received on or before June 19, 2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0033 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,

[[Page 18461]]

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 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: 
omb@cdc.gov.

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

    Zika Postpartum Emergency Response Survey (ZPER), Puerto Rico, 
2017--New ICR--National Center for Chronic Disease Prevention and 
Health Promotion (NCCDPHP), Centers for Disease Control and Prevention 
(CDC).

Background and Brief Description

    In December 2015, the Puerto Rico Department of Health (PRDH) 
reported the first locally acquired (index) case of Zika virus disease 
in the United States. Since then, 38,733 cases have been confirmed in 
Puerto Rico, including 3,076 among pregnant women. Because the most 
common mosquito vector of Zika virus, Aedes aegypti, is present 
throughout Puerto Rico, Zika virus transmission is ongoing. The island 
has been designated at the highest level of risk according to a 3-
tiered Zika virus infection risk scale developed by CDC's Emergency 
Operations Center (EOC).
    While pregnant women do not differ from the general population in 
terms of susceptibility to Zika virus infection or severity of disease, 
they are at risk for adverse pregnancy and birth outcomes associated 
with Zika virus infection during pregnancy. After review of the 
available evidence, CDC concluded that Zika virus infection during 
pregnancy is a cause of microcephaly and other brain defects.
    Given the adverse pregnancy and birth outcomes associated with Zika 
virus infection during pregnancy, it is more important than ever to 
understand the Zika-related concerns of pregnant women, interactions 
regarding Zika between pregnant women and their health care providers, 
sources of information that pregnant women consult regarding Zika 
virus, and use of recommended precautions by pregnant women to reduce 
the risk of exposure to Zika virus. This information was successfully 
collected for the first time in a hospital-based survey of women 24-48 
hours after delivery by the Puerto Rico Department of Health in the 
fall of 2016 (Emergency OMB approval, control #0920-1127), and has been 
critical for informing clinical guidance, developing communication 
messages, and providing resources for pregnant women.
    The currently proposed data collection includes three components. 
The first component is a telephone follow-back survey among a subset of 
the original cohort of participants. This component would be the first 
population-based sample of postpartum women who were pregnant during 
the early period of the Zika outbreak, and would provide information on 
the accessibility and utilization of postpartum and newborn services, 
and continued adherence to Zika prevention behaviors. The second 
component would repeat the hospital-based survey in a second cohort of 
pregnant women to assess the effectiveness of emergency response 
efforts from the first mosquito season and to determine where there is 
a need for further refinement of efforts and outstanding resource gaps. 
As with the first cohort of women who participated in hospital-based 
survey, a subset of women in this second cohort would be invited to 
subsequently participate in a telephone follow-up survey. The third and 
final component will be a separate hospital-based survey for fathers of 
the infants born to mothers in the second cohort of women completing 
the hospital-based survey. This component would assess father's 
concerns about Zika related birth defects and contribution to 
prevention efforts.
    There are no costs to respondents other than their time to 
participate.

[[Page 18462]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per  response   Total burden
                                                    respondents     respondent       (in hrs.)       (in hrs.)
----------------------------------------------------------------------------------------------------------------
Women with recent births......  Maternal                   2,760               1           25/60           1,150
                                 hospital-based
                                 questionnaire.
Fathers with recently born      Father hospital-           1,104               1           15/60             276
 infants.                        based
                                 questionnaire.
Women with live births 2-10     Follow-up phone            2,868               1           15/60             717
 months prior.                   questionnaire.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           2,143
----------------------------------------------------------------------------------------------------------------


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. 2017-07880 Filed 4-18-17; 8:45 am]
 BILLING CODE 4163-18-P

18460 Federal Register / Vol. 82, No. 74 / Wednesday, April 19, 2017 / Notices reduction in burden hours is attributed previously approved forms and primarily to the discontinuation of formatting changes to existing forms. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden Total burden Type of respondent Form name responses per respondents per response hours respondent (in hours) Epidemiologist ............... NORS Foodborne Disease Transmission_Per- 54 37 20/60 666 son to Person Disease Transmission_Animal Contact_Environmental Contamination_Un- known Transmission Mode_52.13. Epidemiologist ............... WHO COLLABORATING CENTER FOR INFLU- 53 52 10/60 460 ENZA Influenza Virus Surveillance. Epidemiologist ............... U.S. WHO Collaborating Laboratories Influenza 113 1 10/60 19 Testing Methods Assessment. Epidemiologist ............... U.S. Outpatient Influenza-like Illness Surveil- 1,800 52 10/60 15,600 lance Network (ILINet) Weekly_CDC 55.20. Epidemiologist ............... U.S. Outpatient Influenza-like Illness Surveil- 1,800 1 5/60 150 lance Network (ILINet) Workfolder 55.20E. Epidemiologist ............... Influenza-Associated Pediatric Mortality Case 57 2 30/60 57 Report Form. Epidemiologist ............... Human Infection with Novel Influenza A Virus 57 2 30/60 57 Case Report Form. Epidemiologist ............... Human Infection with Novel Influenza A Virus 57 1 1.5/60 86 Severe Outcomes. Epidemiologist ............... Novel Influenza A Virus Case Screening Form .. 57 1 15/60 15 Epidemiologist ............... Antiviral Resistant Influenza Infection Case Re- 57 3 30/60 86 port Form. Epidemiologist ............... National Respiratory & Enteric Virus Surveil- 550 52 15/60 7,150 lance System (NREVSS) (55.83A, B, D) (elec- tronic). Epidemiologist ............... National Enterovirus Surveillance Report: (CDC 20 12 15/60 60 55.9) (electronic). Epidemiologist ............... National Adenovirus Type Reporting System 13 4 15/60 13 (NATRS). Epidemiologist ............... Middle East Respiratory Syndrome (MERS) Pa- 57 3 25/60 72 tient Under Investigation (PUI) Short Form. Epidemiologist ............... Viral Gastroenteritis Outbreak Submission Form 20 5 5/60 9 Epidemiologist ............... NORS Waterborne Disease Transmission 57 1 20/60 19 Form_52.12.. Epidemiologist ............... Influenza Virus (Electronic, Year Round), 57 52 5/60 247 PHLIP_HL7 messaging Data Elements. Epidemiologist ............... Influenza virus (electronic, year round) (PHIN– 3 52 5/60 13 MS). Epidemiologist ............... Suspect Respiratory Virus Patient Form ............. 10 5 30/60 25 Total ........................ .............................................................................. ........................ ........................ ........................ 24,804 Leroy A. Richardson, DEPARTMENT OF HEALTH AND government information, invites the Chief, Information Collection Review Office, HUMAN SERVICES general public and other Federal Office of Scientific Integrity, Office of the agencies to take this opportunity to Associate Director for Science, Centers for Disease Control and comment on proposed and/or Office of the Director, Centers for Disease Prevention continuing information collections, as Control and Prevention. required by the Paperwork Reduction [FR Doc. 2017–07902 Filed 4–18–17; 8:45 am] [60Day–17–17ABC; Docket No. CDC–2017– Act of 1995. This notice invites 0033] comment on a proposed information BILLING CODE 4163–18–P collection project titled ‘‘Zika Proposed Data Collection Submitted Postpartum Emergency Response for Public Comment and Survey (ZPER), Puerto Rico, 2017.’’ Recommendations DATES: Written comments must be AGENCY: Centers for Disease Control and received on or before June 19, 2017. jstallworth on DSK7TPTVN1PROD with NOTICES Prevention (CDC), Department of Health ADDRESSES: You may submit comments, and Human Services (HHS). identified by Docket No. CDC–2017– ACTION: Notice with comment period. 0033 by any of the following methods: • Federal eRulemaking Portal: SUMMARY: The Centers for Disease Regulations.gov. Follow the instructions Control and Prevention (CDC), as part of for submitting comments. its continuing efforts to reduce public • Mail: Leroy A. Richardson, burden and maximize the utility of Information Collection Review Office, VerDate Sep<11>2014 15:06 Apr 18, 2017 Jkt 241001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\19APN1.SGM 19APN1

Federal Register / Vol. 82, No. 74 / Wednesday, April 19, 2017 / Notices 18461 Centers for Disease Control and on respondents, including through the Given the adverse pregnancy and Prevention, 1600 Clifton Road NE., MS– use of automated collection techniques birth outcomes associated with Zika D74, Atlanta, Georgia 30329. or other forms of information virus infection during pregnancy, it is Instructions: All submissions received technology; and (e) estimates of capital more important than ever to understand must include the agency name and or start-up costs and costs of operation, the Zika-related concerns of pregnant Docket Number. All relevant comments maintenance, and purchase of services women, interactions regarding Zika received will be posted without change to provide information. Burden means between pregnant women and their to Regulations.gov, including any the total time, effort, or financial health care providers, sources of personal information provided. For resources expended by persons to information that pregnant women access to the docket to read background generate, maintain, retain, disclose or consult regarding Zika virus, and use of documents or comments received, go to provide information to or for a Federal recommended precautions by pregnant Regulations.gov. agency. This includes the time needed women to reduce the risk of exposure to Please note: All public comment to review instructions; to develop, Zika virus. This information was should be submitted through the acquire, install and utilize technology successfully collected for the first time Federal eRulemaking portal and systems for the purpose of in a hospital-based survey of women (Regulations.gov) or by U.S. mail to the collecting, validating and verifying 24–48 hours after delivery by the Puerto address listed above. information, processing and Rico Department of Health in the fall of FOR FURTHER INFORMATION CONTACT: To maintaining information, and disclosing 2016 (Emergency OMB approval, request more information on the and providing information; to train control #0920–1127), and has been proposed project or to obtain a copy of personnel and to be able to respond to critical for informing clinical guidance, the information collection plan and a collection of information, to search developing communication messages, instruments, contact Leroy A. data sources, to complete and review and providing resources for pregnant Richardson, Information Collection the collection of information; and to women. Review Office, Centers for Disease transmit or otherwise disclose the The currently proposed data Control and Prevention, 1600 Clifton information. collection includes three components. Road NE., MS–D74, Atlanta, Georgia Proposed Project The first component is a telephone 30329; phone: 404–639–7570; Email: follow-back survey among a subset of Zika Postpartum Emergency Response omb@cdc.gov. the original cohort of participants. This Survey (ZPER), Puerto Rico, 2017—New SUPPLEMENTARY INFORMATION: Under the component would be the first ICR—National Center for Chronic Paperwork Reduction Act of 1995 (PRA) population-based sample of postpartum Disease Prevention and Health (44 U.S.C. 3501–3520), Federal agencies women who were pregnant during the Promotion (NCCDPHP), Centers for must obtain approval from the Office of early period of the Zika outbreak, and Disease Control and Prevention (CDC). Management and Budget (OMB) for each would provide information on the collection of information they conduct Background and Brief Description accessibility and utilization of or sponsor. In addition, the PRA also In December 2015, the Puerto Rico postpartum and newborn services, and requires Federal agencies to provide a Department of Health (PRDH) reported continued adherence to Zika prevention 60-day notice in the Federal Register the first locally acquired (index) case of behaviors. The second component concerning each proposed collection of Zika virus disease in the United States. would repeat the hospital-based survey information, including each new Since then, 38,733 cases have been in a second cohort of pregnant women proposed collection, each proposed confirmed in Puerto Rico, including to assess the effectiveness of emergency extension of existing collection of 3,076 among pregnant women. Because response efforts from the first mosquito information, and each reinstatement of the most common mosquito vector of season and to determine where there is previously approved information Zika virus, Aedes aegypti, is present a need for further refinement of efforts collection before submitting the throughout Puerto Rico, Zika virus and outstanding resource gaps. As with collection to OMB for approval. To transmission is ongoing. The island has the first cohort of women who comply with this requirement, we are been designated at the highest level of participated in hospital-based survey, a publishing this notice of a proposed risk according to a 3-tiered Zika virus subset of women in this second cohort data collection as described below. infection risk scale developed by CDC’s would be invited to subsequently Comments are invited on: (a) Whether Emergency Operations Center (EOC). participate in a telephone follow-up the proposed collection of information While pregnant women do not differ survey. The third and final component is necessary for the proper performance from the general population in terms of will be a separate hospital-based survey of the functions of the agency, including susceptibility to Zika virus infection or for fathers of the infants born to mothers whether the information shall have severity of disease, they are at risk for in the second cohort of women practical utility; (b) the accuracy of the adverse pregnancy and birth outcomes completing the hospital-based survey. agency’s estimate of the burden of the associated with Zika virus infection This component would assess father’s proposed collection of information; (c) during pregnancy. After review of the concerns about Zika related birth ways to enhance the quality, utility, and available evidence, CDC concluded that defects and contribution to prevention clarity of the information to be Zika virus infection during pregnancy is efforts. collected; (d) ways to minimize the a cause of microcephaly and other brain There are no costs to respondents burden of the collection of information defects. other than their time to participate. jstallworth on DSK7TPTVN1PROD with NOTICES VerDate Sep<11>2014 15:06 Apr 18, 2017 Jkt 241001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\19APN1.SGM 19APN1

18462 Federal Register / Vol. 82, No. 74 / Wednesday, April 19, 2017 / Notices 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.) Women with recent births ................. Maternal hospital-based question- 2,760 1 25/60 1,150 naire. Fathers with recently born infants .... Father hospital-based questionnaire 1,104 1 15/60 276 Women with live births 2–10 months Follow-up phone questionnaire ........ 2,868 1 15/60 717 prior. Total ........................................... ........................................................... ........................ ........................ ........................ 2,143 Leroy A. Richardson, Prevention, 1600 Clifton Road, NE., proposed collection of information; (c) Chief, Information Collection Review Office, MS–D74, Atlanta, Georgia 30329. ways to enhance the quality, utility, and Office of Scientific Integrity, Office of the Instructions: All submissions received clarity of the information to be Associate Director for Science, Office of the must include the agency name and collected; (d) ways to minimize the Director, Centers for Disease Control and Docket Number. All relevant comments burden of the collection of information Prevention. received will be posted without change on respondents, including through the [FR Doc. 2017–07880 Filed 4–18–17; 8:45 am] to Regulations.gov, including any use of automated collection techniques BILLING CODE 4163–18–P personal information provided. For or other forms of information access to the docket to read background technology; and (e) estimates of capital documents or comments received, go to or start-up costs and costs of operation, DEPARTMENT OF HEALTH AND Regulations.gov. maintenance, and purchase of services HUMAN SERVICES to provide information. Burden means Please note: All public comment should be Centers for Disease Control and submitted through the Federal eRulemaking the total time, effort, or financial Prevention portal (Regulations.gov) or by U.S. mail to the resources expended by persons to address listed above. generate, maintain, retain, disclose or [60Day–17–17NF; Docket No. CDC–2017– provide information to or for a Federal 0006] FOR FURTHER INFORMATION CONTACT: To request more information on the agency. This includes the time needed proposed project or to obtain a copy of to review instructions; to develop, Proposed Data Collection Submitted acquire, install and utilize technology for Public Comment and the information collection plan and instruments, contact Leroy A. and systems for the purpose of Recommendations collecting, validating and verifying Richardson, Information Collection AGENCY: Centers for Disease Control and Review Office, Centers for Disease information, processing and Prevention (CDC), Department of Health Control and Prevention, 1600 Clifton maintaining information, and disclosing and Human Services (HHS). Road, NE., MS–D74, Atlanta, Georgia and providing information; to train ACTION: Notice with comment period. 30329; phone: 404–639–7570; Email: personnel and to be able to respond to omb@cdc.gov. a collection of information, to search SUMMARY: The Centers for Disease data sources, to complete and review SUPPLEMENTARY INFORMATION: Under the Control and Prevention (CDC), as part of the collection of information; and to Paperwork Reduction Act of 1995 (PRA) its continuing efforts to reduce public transmit or otherwise disclose the (44 U.S.C. 3501–3520), Federal agencies burden and maximize the utility of information. must obtain approval from the Office of government information, invites the Management and Budget (OMB) for each Proposed Project general public and other Federal collection of information they conduct agencies to take this opportunity to or sponsor. In addition, the PRA also ZIRP Puerto Rico Study: Zika Virus comment on proposed and/or requires Federal agencies to provide a RNA Persistence in Pregnant Women continuing information collections, as 60-day notice in the Federal Register and Congenitally-Infected Infants in required by the Paperwork Reduction concerning each proposed collection of Puerto Rico—New—National Center for Act of 1995. This notice invites information, including each new Emerging and Zoonotic Infectious comment on a proposed information proposed collection, each proposed Diseases (NCEZID), Centers for Disease collection project titled ‘‘ZIRP Puerto extension of existing collection of Control and Prevention (CDC). Rico Study: Zika Virus RNA Persistence information, and each reinstatement of in Pregnant Women and Congenitally- Background and Brief Description previously approved information Infected Infants in Puerto Rico.’’ collection before submitting the Zika virus (ZIKV) infection is a DATES: Written comments must be collection to OMB for approval. To mosquito-borne flavivirus transmitted received on or before June 19, 2017. comply with this requirement, we are by Aedes species mosquitoes, and also ADDRESSES: You may submit comments, publishing this notice of a proposed through sexual and mother-to-child identified by Docket No. CDC–2017– transmission; laboratory-acquired jstallworth on DSK7TPTVN1PROD with NOTICES data collection as described below. 0006 by any of the following methods: Comments are invited on: (a) Whether infections have also been reported. • Federal eRulemaking Portal: the proposed collection of information Evidence of human ZIKV infection was Regulations.gov. Follow the instructions is necessary for the proper performance observed sporadically in Africa and for submitting comments. of the functions of the agency, including Asia prior to 2007 when an outbreak of • Mail: Leroy A. Richardson, whether the information shall have ZIKV caused an estimated 5,000 Information Collection Review Office, practical utility; (b) the accuracy of the infections in the State of Yap, Federated Centers for Disease Control and agency’s estimate of the burden of the States of Micronesia. VerDate Sep<11>2014 15:06 Apr 18, 2017 Jkt 241001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\19APN1.SGM 19APN1


Document Created: 2018-11-14 09:44:07
Document Modified: 2018-11-14 09:44:07
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 June 19, 2017.
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 18460 
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