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)

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, 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: 
[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

    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
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                                                                     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
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2017-07880 Filed 4-18-17; 8:45 am]
 BILLING CODE 4163-18-P