Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Health and Human Services Centers for Disease Control and Prevention [30Day-18-18TH]
 In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Assessment of a Preventive Service Program in the Context of a Zika Virus Outbreak in Puerto Rico” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on March 30, 2018 to obtain comments from the public and affected agencies. CDC received one non-substantive comment to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments. CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, 
                    *e.g.,*
                     permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to 
                    *omb@cdc.gov.*
                     Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication. Proposed Project Assessment of a Preventive Service Program in the Context of a Zika Virus Outbreak in Puerto Rico—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Puerto Rico has reported the highest number of Zika virus infections in the United States, including infections in pregnant women. Zika virus infection during pregnancy has been identified as a cause of microcephaly and other severe brain abnormalities, and has been linked to other problems such as miscarriage, stillbirth, defects of the eye, hearing deficits, limb abnormalities, and impaired growth. One strategy to prevent these devastating outcomes is to prevent unintended pregnancy among women at risk of Zika virus infection. To this end, an initiative was launched in April 2016 to train physicians at clinics across Puerto Rico to provide patient-centered services to women who chose to delay or avoid pregnancy during the Zika virus outbreak. As part of the public health response to the Zika virus outbreak, CDC seeks to assess approaches to mitigating the effects of Zika virus infection and determine which approaches have utility. Previous assessment of the prevention program indicated high satisfaction of patients with program services. The specific objectives of this data collection are to assess (1) prevention strategy adherence among patients at approximately 18 months after receipt of program services; and (2) prevention strategy adherence, patient satisfaction, and unmet need for services among participants at approximately 30 months after receipt of program services. The practical utility of the information to be collected as part of this project is to assess services delivered to women in Puerto Rico, monitor outcomes of interest, and determine potential for replication/adaptation in other jurisdictions similarly affected by the Zika virus or during other emergency responses. For the information collection, CDC plans to conduct online surveys with 1,920 patients approximately 18 months after receiving program services and 1,760 patients approximately 30 months after receiving program services. The number of patients surveyed is based on an initial sample of 3,200 patients invited to participate, anticipating a 60% response rate at 18 months and a 55% response rate at 30 months. Participation in all data collection activities will be completely voluntary. OMB approval is requested for two years. Total Annualized Burden Hours are estimated to be 259, and there are no costs to respondents other than their time.
                    ( print page 34589) Estimated Annualized Burden Hours
Type of respondents
Form name
Number of
                             respondents
Number of
                             responses per 
                             respondent
Average
                             burden per 
                             response 
                             (in hours)Patients aged 18 years or older
Online surveys (18-month follow-up)
960
1
7/60Patients aged 18 years or older who completed 18 mo survey
Online surveys (30-month follow-up)
660
1
10/60Patients aged 18 years or older who did not complete 18 mo survey
Online surveys (30-month follow-up)
220
1
10/60
 Jeffrey M. Zirger, Acting 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. 2018-15524 Filed 7-19-18; 8:45 am] BILLING CODE 4163-18-P