Approved consistent with the understanding that associated collections extending beyond 6
months will be submitted to OMB as a non-emergency information collection request for formal
review.
Inventory as of this Action
Requested
Previously Approved
09/30/2016
6 Months From Approved
3,250
0
0
58
0
0
0
0
0
Information on the frequency and duration of Zika virus shedding in semen and urine is needed urgently to inform public health recommendations for infected men and their partners. The purpose of this study is to enroll adult men with confirmed Zika virus infection and collect serial specimens of semen and urine. This study will fill gaps in the scientific knowledge base for Zika virus regarding the occurrence, persistence, and transmissibility of Zika virus in urine and semen.
Zika virus is an arthropod-borne flavivirus that has recently emerged in the Americas. Maternal infection has been linked to congenital microcephaly, fetal loss, and other adverse reproductive health outcomes. Although spread primarily by mosquitoes, recent reports have highlighted the potential for sexual transmission of Zika virus through the semen of infected men. The purpose of this study is to enroll adult men with confirmed Zika virus infection and collect serial specimens of semen and urine. This study will fill gaps in the scientific knowledge base for Zika virus regarding the occurrence, persistence and transmissibility of Zika virus in urine and semen. This is a prospective, descriptive cohort study that allows for determining the persistence of shedding Zika virus in semen and urine through serial specimen collection from individuals with confirmed Zika virus.The results of this study will be of great relevance to provide evidence-based information to circumvent Zika virus transmission. Results and analysis will be used to update and refine relevant counseling messages and recommendations as well as provide understanding for future Zika virus outbreaks..
US Code:
42 USC 241
Name of Law: Public Health Service Act
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Follow-Up Survey
SSA zika emergency III 28MAR2016.docx
Att. A -- Section 301 of the Public Health Service Act (42 USC 241).pdf
Follow-Up Survey