This PDF is the current document as it appeared on Public Inspection on 04/18/2017 at 08:45 am.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
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.”
Written comments must be received on or before June 19, 2017.
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, Start Printed Page 18461Centers 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.Start Further Info
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@example.com.End Further Info End Preamble Start Supplemental 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.
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.Start Printed Page 18462
|Type of respondents||Form name||Number of respondents||Number of responses per respondent||Average burden per response (in hrs.)||Total burden (in hrs.)|
|Women with recent births||Maternal hospital-based questionnaire||2,760||1||25/60||1,150|
|Fathers with recently born infants||Father hospital-based questionnaire||1,104||1||15/60||276|
|Women with live births 2-10 months prior||Follow-up phone questionnaire||2,868||1||15/60||717|
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]
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