Pregnant Women in PR SSA_FINAL 01SEP2017

Goals: To assess the delivery and effects of interventions implemented in Puerto Rico to protect pregnant women from Zika virus infections and the birth defects that Zika virus can cause in their babies. Starting in April 2016, the Puerto Rico Department of Health has implemented a variety of interventions to help pregnant women prevent getting infected with Zika virus during their pregnancy including: de:
- Zika Education Sessions (at Women, Infants, and Children [WIC] clinics)
- Zika Prevention Kits
- Zika testing
- Communications activities
- Partnership engagement to mobilize community members
- Vector control services in and around the home of pregnant women
- Vector control activities in the community (traps, larviciding, community clean-up campaigns, etc.)
- Mobilization of mental health services for pregnant women
Intended use: Information collected in this assessment will be used to help refine interventions that have been conducted to prevent and control Zika virus in Puerto Rico and to assess which interventions reduce risk and/or offer protection from Zika virus infections.
Methods: Telephone interviews will be conducted with pregnant women in Puerto Rico. For assessment of intervention delivery and associated outcomes, a random sample stratified by pregnancy trimester will be drawn from WIC enrollment data.
Subpopulation: Pregnant women living in Puerto Rico enrolled in the federal supplemental nutrition program for Women, Infants, and Children (WIC).
Data analysis: Quantitative data will be analyzed using SPSS or SAS. Qualitative data will be transcribed. The text responses will be uploaded to NVivo, ATLAS ti, or MAXQDA and analyzed for themes.

CDC requests OMB approval of an existing information collection in use without an OMB control number. CDC is seeking OMB approval until December 2017. The activities described in this collection are a continuation of OMB Control number 0920-1118 (expired 12/31/16), an emergency ICR approved by OMB in June, 2016. This ICR includes continuing one project which is part of CDC’s ongoing response in Puerto Rico to the Zika virus outbreak.

1. Circumstances Making the Collection of Information Necessary

In December 2015, the Commonwealth of Puerto Rico, a United States territory, reported its first confirmed locally transmitted Zika virus case.

Starting in March 2016, CDC’s National Center for Emerging and Zoonotic Infections Diseases (NCEZID) initiated several interventions targeting pregnant women. The ultimate goal of these interventions is/was to protect pregnant women from Zika virus and encourage Zika prevention behaviors among pregnant women. The interventions include the following:

Zika Education Sessions (at WIC clinics)
Zika Prevention Kits
Zika testing
Communication activities
Partnership engagement to mobilize community members
Vector control services in and around the home of pregnant women
Vector control activities in the community (traps, larviciding, community clean-up campaigns, etc.)
Mobilization of mental health services for pregnant women

The Zika Prevention Kit is a tote bag that contains: insect repellant, educational materials about Zika prevention, condoms, a thermometer, mosquito dunks for treating accumulated water, and a bed net. The objectives of the Zika prevention kit were to increase women’s knowledge of Zika prevention behaviors and provide women with the tools needed to engage in Zika prevention behaviors (e.g., insect repellant, condoms, and a bed net). In March 2016, an assessment of the Zika Prevention kit among pregnant women in Puerto Rico was conducted (OMB Gen IC No. 0920-1071).

Over the past six months and continuing now, a mass media communication campaign and many community engagement/outreach efforts focused on reducing mosquito breeding sites have been added as important interventions to help protect pregnant women and their babies (OMB Gen-IC No. 0920-0572).

In March 2016, an assessment was conducted among pregnant Puerto Rican women about their personal protective behaviors for Zika prevention as well as their perceptions of vector control strategies (OMB Gen IC No. 0920-0572). Both this assessment and the one done for the Zika prevention kits gathered qualitative insights from pregnant women that were helpful in describing the perceptions of pregnant women about many Zika prevention activities.

Since the approval of OMB control number 0920-1118, the behavioral science team has produced monthly data summaries and recommendations to Zika incident response leaders in Puerto Rico. These reports have been used as “feedback loops” on whether services intended to help pregnant women are reaching them and having the intended effects. For example, early in the response, over 90% of pregnant women reported receiving a Zika Prevention Kit. However, over time, this information collection showed that fewer and fewer pregnant women reported receiving them. This information was shared with response leaders and efforts to understand why pregnant women were not receiving them were initiated. Eventually, gaps in distribution and issues of storage were discovered and resolved so that Zika Prevention Kit distribution numbers have started to increase again. Another finding from the initial information collection was that pregnant women were reporting that they were staying inside their homes to protect themselves from Zika. This raised concerns about mental health and social support needs of pregnant women. The Puerto Rico health department hired a psychologist to join the Zika response effort to work with home visiting programs and social service providers to prepare for meeting the needs of pregnant women, especially pregnant women who have babies affected by Zika.

Since June 2016 and throughout 2017, incident response leaders have been receiving information that they have been using to shape different facets of the response especially as the Zika response in Puerto Rico has dramatically declined. On June 5, 2017, Puerto Rico health officials declared that the Zika epidemic was over saying that transmission of the virus on the island has fallen to relatively low levels. The territorial epidemiologist and incident manager, Dr. Carmen Deseda, said, ‘while there are very low levels of mosquito-borne Zika transmission now, it is important that we remain vigilant to keep these numbers down and support families already affected by Zika” (StatNews.com article by Helen Branswell). The Zika response within the Puerto Rico Emergency Operations Center including the Joint Information Center (JIC) was deactivated by the end of June with the Puerto Rico Incident Manager meeting with staff on an “as needed” basis and requesting weekly email communication updates from anyone working on Zika. As the outbreak continues and as the response continues, leaders want this feedback loop to continue.

This request is for continuing data collection through December 2017 to continue tracking Zika interventions and their effects among pregnant women in Puerto Rico. Specifically, CDC needs this assessment to ensure that Zika prevention activities effectively educate, equip, and encourage women to participate in as many Zika prevention behaviors as possible. On-going assessment is an important part of this program because it can reveal novel ways that women protect themselves from Zika, how effective the distribution of the Zika Prevention Kit has been in Puerto Rico, perceived severity and susceptibility to Zika, pregnant women’s self-efficacy in protecting themselves from Zika after the interventions have been implemented, as well as the extent to which target populations are using contents of the Zika Prevention Kit. As the Zika response effort has declined so has pregnant women’s understanding of the importance of performing protective behaviors. Many more pregnant women are NOT hearing about Zika virus, not performing protective behaviors, and not receiving Zika Prevention Kits or laboratory testing results, even though there is still a possibility of becoming infected. In addition, questions about social support have been showing that most pregnant women say they have people who offer them practical support.

As the outbreak evolves, interviews with pregnant women in Puerto Rico can help articulate motivations for and against engaging in Zika prevention behaviors that are critical for preventing Zika-associated birth defects and morbidities. Implementing changes based on results from this assessment has occurred with the previous information collection and is expected to facilitate program improvement and ensure the most efficient allocation of resources for this public health emergency. Understanding risk and protective factors related to interventions and behaviors of pregnant women can help to establish priorities. As the outbreak and the response to the outbreak has declined, so have the beliefs and behaviors of pregnant women. During the peak of the outbreak, most pregnant women reported performing protective behaviors. However, during 2017, fewer pregnant women are reporting performing protective behaviors. Analyses of the data gathered over time will help us know more about the behaviors that were most and least do-able as well as the motivations for and against each of them. These analyses may be helpful in addressing other vector-borne diseases (e.g., Dengue, Chikungunya) that have many of the same recommended behaviors even if they have different disease presentations and consequences than Zika.

Authorizing legislation comes from Section 301 of the Public Health Service Act (Attachment A).

2. Purpose and Use of the Information Collection

The goal is to find out if interventions are reaching pregnant women and having the intended outcomes along with getting feedback from pregnant women about the Zika prevention activities that have been implemented (e.g., Zika education sessions and prevention kits, vector control services, and communication activities).

Attachment F shows a logic model of the interventions and their intended outcomes. Because there are many types of interventions targeting pregnant women as well as efforts to engage community members to take action on behalf of pregnant women, the team has proposed two telephone surveys to assess exposure to receipt of interventions as well as the intended outcomes of the interventions. Most of the questions in the initial telephone interview (Attachment C) measure the interventions (left side of model) along with important factors. The second interview (Attachment D) focuses mostly on the intended outcomes of the interventions (right side of logic model). Follow-up telephone calls will be initiated two weeks after the initial telephone interview. This provides enough time for initial responses and topics covered in the initial interview to be firmly removed from short-term memory.

OMB Control No. 0920-1118 had both initial and follow-up interviews occurring on a monthly basis (six times in six months). This request has both initial and follow-up interviews occurring in the same month, but occurring every other month (e.g., February, April, June, and August 2017).

The two-staged interview process has likely been a big factor in very low refusal rate (~4%). So, the team proposes continuing the current approach. While it is possible for the assessment to try to assess all of these factors in one telephone interview, it would be a very long telephone interview which pregnant women might be less likely to participate in. In addition, there are several reasons why the team proposed an approach of conducting an initial interview followed by another brief telephone interview:

The interventions and behavioral recommendations that are targeting pregnant women are numerous and complex. The main focus of the first interview is to assess exposure or receipt of messages and/or interventions that are targeting them as well as some preliminary feedback on relevance (beliefs about personal risk), resources (physical and social supports), initial responses or actions they are taking and beliefs about what they need or think is needed to protect pregnant women and their babies. The second interview does not ask about interventions aimed to help them, but rather gathers self-reported information on the key behavioral recommendations for pregnant women along with their report of any community action/mobilization regarding Zika virus prevention.

A telephone interview offers an opportunity to remind and/or clarify to pregnant women what the important protective behaviors are as well as to hear obstacles they may be encountering and to make connections to services or resources that can help them overcome obstacles. WIC and PRDH are keenly interested in responding to insights gathered each month to improve the supports that are being offered to pregnant women.
Zika outbreak response and prevention efforts are dynamic and evolving and are almost as dynamic as the pregnancy experience itself. The behaviors we are asking pregnant women to engage in need to be performed from conception to delivery – and establishing and maintaining those behaviors requires many different types of support – which is why many of the interventions have been designed and are being delivered. As the epidemic evolves, we will need to evolve based on new information about Zika but also new information about the needs of the pregnant women we are speaking with. A second call gives the pregnant woman a second opportunity to share her experience in performing behaviors and in witnessing community action (or inaction) in the context of change.

We believe that the approach of interviewing a pregnant woman in two brief telephone surveys will offer intended beneficiaries of interventions to provide important feedback on the services so that program deliverers can make improvements in real-time. Because each respondent will only receive one initial interview followed by one follow-up interview, the information collection will not be overly burdensome to respondents. Experience with the first information collection has shown that pregnant women are very willing to participate in these interviews (with only a 4% refusal rate). The most challenging aspect has been reaching pregnant women by phone since the phone numbers provided to us by WIC are not always the current phone number for the pregnant woman.

Findings have been and will continue to be used to improve the delivery of interventions and to inform decisions about future Zika prevention activities for pregnant women in Puerto Rico. PRDH and CDC intend for these data to be collected in real time and used in real time. We expect to collect data on a bi-monthly (every other month) basis that is reviewed by incident management team members and used to improve interventions for pregnant women in Puerto Rico. The plan is to conduct up to 300 initial interviews and up to 150 follow-up interviews every other month until the end of the 2017 fiscal year (February, April, June, and August 2017).

Based on the first information collection, the team has excellent experience knowing how to complete the calls within the timeframe proposed. After each wave of interviews, the information collected will be analyzed and a report developed and delivered to the leaders of the response. Based on the richness of insights gleaned from the previous information collections, we expect that the reports will continue to offer insights on the delivery of interventions to pregnant women. The information will be used to make recommendations for improving interventions. Information may also be used to develop presentations, reports, and manuscripts to document the program and lessons learned in order to inform future programs of this sort.

The following factors will continue be assessed:

Exposure/experience with receiving interventions targeting pregnant women
Knowledge about Zika virus and related prevention behaviors
Self-efficacy in engaging in Zika prevention behaviors
Engagement in Zika prevention behaviors (e.g., protective clothing use, condom use, and bed net use)
Knowledge about, attitudes about, and use of the Zika Prevention Kit materials
Knowledge about, attitudes about, and use of environmental vector control activities
Risk perceptions of Zika
Exposures to communications along with other factors that may be important considerations in their taking action or not (e.g., does their house have screens, etc.)

Based on identified needs, the team is proposing to also assess social and emotional support needs of pregnant women.

We will conduct telephone interviews with a mix of closed-ended and open-ended questions with pregnant women. We estimate 1,200 pregnant women will participate in the project (300 women in each of four separate rounds of interviews).

Results of this project will have limited generalizability. However, results of this assessment should provide information that can be used to enhance and revise the existing program as well as offer lessons learned to inform infectious disease control programs that use education materials.

3. Use of Improved Information Technology and Burden Reduction

Collected data will be entered into a computer that is preloaded with an Epi-Info form that will be developed specifically for this effort. However, paper documents will be available as a backup due to intermittent electricity and technology access. Telephone interviewers will be responsible for data entry and the project manager will perform data quality control measures.

4. Efforts to Identify Duplication and Use of Similar Information

CDC is not aware of any other current systematic collection of the information described herein in Puerto Rico. See section A.1 for a discussion of previous similar work upon which this current collection builds. Based on the usefulness of this type of information for Puerto Rico’s response, a separate but similar information collection was approved for and conducted in the U.S. Virgin Islands in November 2016 (OMB Control No. 0920-1147). A completely different sampling strategy was necessary since most pregnant women in the U.S. Virgin Islands are not enrolled in the Women, Infants, and Children (WIC) program like they are in Puerto Rico.

5. Impact on Small Businesses or Other Small Entities

The collection of information does not primarily involve small entities. However, for the small entities involved, the burdens imposed by CDC’s information collection requirements have been reduced to the minimum necessary for CDC to meet its regulatory and public health responsibilities.

CDC has contracted with Caduceus to provide support services for Zika related efforts. According to its website (www.caduceusstaffing.com), Caduceus is a “Certified and Verified 8(a), HUBZone, and Service Disabled Veteran Owned Small Business (SDVOSB) that provides healthcare, information technology and security, and scientific services for our clients.” Caduceus staff will place the phone calls and enter data from the phone calls for this project.

6. Consequences of Collecting the Information Less Frequently

This is a request to continue a one-time data collection that involves two encounters (an initial interview and a follow-up interview) related to on-going Zika prevention outreach efforts that are a result of an unprecedented public health emergency. Specifically, without this information, CDC’s ability to effectively serve pregnant women through education, communication, and services, may be compromised.

Assessment (feedback loop) is important to delivering multi-faceted interventions because it can reveal why specific activities occur—or do not occur—as planned, as well as showing whether the interventions are having the intended or unintended effects. In particular, results gained through this assessment can facilitate program improvement and ensure good stewardship of resources. The information collected to date has been used by response leaders to improve interventions intended to help pregnant women.

Findings from this assessment will be used to guide current prevention efforts and provide feedback about intervention effectiveness and outcomes.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

The activities outlined in this package fully comply with all guidelines of 5 CFR 1320.5.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A. A 60-day Federal Register notice was published in the Federal Register on December 30, 2016, Vol. 81, No. 251, pages 96461-96462 (Attachment B). One non-substantive public comment was received (Attachment B1) and CDC sent a standard response.

B. Leaders in the Puerto Rico Department of Health’s incident command structure have used the information collected over the past six months and have been involved in discussions and decisions about continuing this assessment. Puerto Rico leaders recommend that all telephone interviewers be locally employed staff who speak Spanish.

9. Explanation of Any Payment or Gift to Respondents.

From July 2016 to July 2017, a raffle was offered to participants (one first-prize winner received a $100 gift card; one second-prize winner received a $75 gift card; and one third-prize winner received a $50 gift card). At the time, doing so was seen as an appropriate way to improve response rates, improve data quality, and show appreciation for participants’ time.

Following OMB review in July 2017, the use of a raffle has been discontinued. No further payments or gifts will be offered.

10. Protection of the Privacy and Confidentiality of Information Provided by Respondents

NCEZID’s Information Systems Security Officer reviewed this submission and determined that the Privacy Act does not apply. No information in identifiable form will be collected.

Impact the proposed collection will have on the respondent’s privacy

Prior to participating in the assessment via telephone, the telephone interviewer will read prospective respondents their rights as participants, and contacts for more information about the project. Verbal consent from the participant will be requested. Prior to the beginning of the assessment, a staff member will also address any questions the participants have about the project. Participants must provide verbal consent at the time of each interview before any information will be collected.

The assessment has no foreseeable risks other than the very low risk of breach of security. Women are not required to participate. The choice to participate is completely voluntary and will not have any influence on their WIC eligibility status. Participants have the right to withdraw at any time for any reason. None of the information being collected would reasonably place subjects at risk of criminal or civil liability, or be damaging to their financial standing, employability or reputations. The data collected will be retained for up to one year and then all data will be destroyed.

Final reports, manuscripts, and presentations will contain no information regarding identities of the participants. All collected data will be destroyed within one year after the data collection is complete.

Whether individuals are informed that providing the information is voluntary or mandatory

Participation in the assessment is voluntary. Prior to the beginning of the information collection, a staff member will also address any questions the participants have about the project and provide a CDC project email and phone number. Participants must provide verbal consent at the time of each telephone interview before any information will be collected. Telephone interviews will only be conducted with those who agree to participate. Participants will be informed they are free to skip questions they do not wish to answer, respond “I don’t know,” or end the interview at any time for any reason. Once informed of this information, participants’ agreement to participate in the interview will be their consent to participate in the assessment.

Opportunities to consent, and share submission of information

Participation in the assessment is voluntary. Participants must provide verbal consent at the time of the telephone interview before any information will be collected. Telephone interviews with pregnant women will only be conducted with those who agree to participate. Participants will have to provide consent before the initial interview and the follow-up interview.

Information secured

Stringent safeguards are in place to ensure a respondent’s security including authorized users, physical safeguards, and procedural safeguards.

Authorized users: A database security package is implemented on CDC’s and the contractor’s computer systems to control unauthorized access to the system. Attempts to gain access by unauthorized individuals are automatically recorded and reviewed on a regular basis. Access is granted to only a limited number of CDC staff or its contractors as authorized by the system manager to accomplish the stated purposes for which the data in this system have been collected.

Physical safeguards: Access to the CDC facility where the mainframe computer is located is controlled by a cardkey system. Access to the computer room is controlled by a cardkey and security code (numeric code) system. Access to the data entry area is also controlled by a cardkey system. Guard service in buildings provides personnel screening of visitors. The computer room is protected by an automatic sprinkler system, numerous automatic sensors are installed, and a proper mix of portable fire extinguishers is located throughout the computer room. Computer files are backed up on a routine basis. Hard copy records are stored in locked cabinets at the Emergency Operations Center in Puerto Rico.

Procedural safeguards: Protections for computerized records include programmed verification of valid user identification code and password prior to logging on to the system, mandatory password changes, limited log-ins, virus protection, and user rights/file attribute restrictions. Password protection imposes user name and password log-in requirements to prevent unauthorized access. Each user name is assigned limited access rights to files and directories at varying levels to control file sharing. There are routine daily back-up procedures, and secure off-site storage is available. To avoid inadvertent data disclosure, measures are taken to ensure that all data are removed from electronic medical containing Privacy Act information. Finally, CDC and contractor employees who maintain records are instructed to check with the system manager prior to making disclosures of data. When individually identified data are being used in a room, admittance at either CDC or contractor sites is restricted to specifically authorized personnel. Privacy Act provisions are included in contracts and the CDC Project Director, contract officers and project officers oversees compliance with these requirements.

System of Records

No system of records is being created for this information collection.

11. Institutional Review Board (IRB) and Justification for Sensitive Questions

Sensitive questions

No sensitive questions will be asked during the initial telephone interview (Attachment C). However, questions about behaviors related to the sexual transmission of Zika virus will be asked in the follow-up telephone interview (Attachment D). For example, participants will be asked about intercourse and condom use behaviors. To minimize the possibility of distress, participants will be informed that the interview is voluntary, and they are free to skip questions they do not wish to answer, respond “I don’t know,” or end the interview at any time for any reason.

Institutional Review Board (IRB)

This project was reviewed by the Scientific Regulations Advisor for the National Center for Emerging and Zoonotic Infectious Diseases and determined to be “public health non-research” (Attachments F).

12. Estimates of Annualized Burden Hours and Costs

The estimate for burden hours is based on the experience from doing these interviews for the past six months. The Initial Telephone Interview (Attachment C), including time for reviewing instructions, took an average of 17 minutes, and the follow-up interview (Attachment D) took an average of 10 minutes. We are proposing the same burden request for the initial interview since we are proposing to add four questions about emotional and social support. We are reducing the burden request for the follow-up interview since the average is 5 minutes shorter than what we estimated for OMB Control No. 0920-1118.

Table A: Estimated Annualized Burden Hours and Costs

Type of Respondent	Form Name	No. of Respondents	No. of Responses per Respondent	Average Burden per Response	Total Burden Hours
Pregnant WIC participant	Initial Telephone Interview	1,200	1	20/60	400
Pregnant WIC participant	Follow-up Telephone Interview	600	1	10/60	100
Total					500

Respondents will be drawn from enrollees of Puerto Rico’s supplemental food and nutrition assistance program called Women, Infants, and Children’s (WIC). The program bases eligibility on household income. According to a report by the USDA’s Food and Nutrition Service examining nutrition assistance benefits in Puerto Rico (http://www.fns.usda.gov/sites/default/files/ops/PuertoRico-Cash.pdf), most beneficiaries came from households with 4 or fewer people. Since unemployment is high in Puerto Rico and incomes have been decreasing and are much lower than mainland mean hourly wages, we weighted the annual household income eligibility requirements for WIC by the proportion of households in each category. The following table shows the household size, income eligibility, proportion of program participants.

Household size	Annual income eligibility level	Proportion of Nutrition Assistance Program Participants in Puerto Rico
1	$21,775	24.9%
2	$29,471	31.5%
3	$37,167	19.8%
4	$44,863	2.9%

Hourly wage estimates can be made with the following calculation: [.249 x $21,775 + .315 x $29,471 + .198 x $37,167 + .029% x $44,863] = $23,365.75 ÷ 52 weeks ÷ 40 hours = $11.23

Based on the calculated hourly wage rate of $11.23, Table B shows the estimated burden and costs for 1,200 respondents using the Initial Telephone Interview Guide (Attachment C), and 600 respondents using the Follow-up Telephone Interview Guide (Attachment D). The total estimated cost burden is $5,615.00.

Table B. Estimated Annualized Cost to Respondents

Type of Respondent	Form Name	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
Pregnant WIC participant	Initial Telephone Interview	400	$11.23	$4,492.00
Pregnant WIC participant	Follow-up Telephone Interview	100	$11.23	$1,123.00
Total				$5,615.00

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

There will be no costs to the participants other than their time to participate in the telephone interviews.

14. Annualized Cost to the Government

There are no equipment costs. The only cost to the federal government would be the travel and salary of the CDC staff supporting the design (protocol and instrument development as well as IRB and OMB approvals), implementation (data collection), and analysis and reporting. The estimated cost to the federal government rates were obtained from the Office of Personnel Management’s website (http://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2014/general-schedule/) using Atlanta, Georgia localities. Actual salaries may vary by the location and step for each participating employee. The total cost is $52,575.10. Table C describes how this cost estimate was calculated.

Table C: Annualized Cost to the Government

Staff (FTE)	Average Hours per Collection	Average Hourly Rate	Average Cost
Operations Director of Puerto Rico Zika Response (Commission Corps, Medical Officer)	20	$74.70	$1,494.00
Associate Director for Behavioral Science, NCEZID (GS 15) Primary in assessment design, data analysis, and outputs.	50	$ 76.46	$3,823.00
Behavioral Scientist, CDC deployee to Puerto Rico Health Department (GS 13) Primary in oversight data analysis, and outputs. Support in data collection	120	$ 42.31	$5,077.20
Health scientist/Evaluation fellow NCEZID (GS 12) Support for data analysis and reporting.	180	35.58	$6,404.40
Public health educators/communication specialists, and analysis (Caduceus contractors hired locally in Puerto Rico)(Contractor) Primary in data collection - conducting telephone interviews, data entry, quality control, transcription, and translation of open-ended responses	2074	$ 17.25	$35,776.50
Estimated Total Cost of Information Collection			$52,575.10

Contractor pay is based on Bureau of Labor statistics wage estimates for “Telephone operators.” Operations Director of Puerto Rico Zika Response (Commission Corps, Medical Officer) pay based on 05 level.

15. Explanation for Program Changes or Adjustments

This is a new information collection request.

16. Plans for Tabulation and Publication and Project Time Schedule

A summary of this timeline is provided below:

Project Time Schedule	Timing
Data Collection	February, April, June, August 2017
Data Analysis	Data analysis will begin right after each month’s data collection is completed
Monthly report and communications for making improvements to interventions	3 weeks after prior months data collection
Improvement of intervention efforts	2 weeks after bi-monthly report

17. Reason(s) Display of OMB Expiration Date is Inappropriate

The OMB expiration date will be displayed.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

Attachments

Authorizing Legislation – Public Health Service Act
60-Day FRN

B1. Public comment

Initial Telephone Interview of Women
Follow up Telephone Interview of Women
IRB Letter of Determination
Logic Model of Puerto Rico Zika Response Activities

References

Food and Nutrition Service, United States Department of Agriculture, Examination of Cash Nutrition Assistance Programs Benefits in Puerto Rico, August 2015

http://www.fns.usda.gov/sites/default/files/ops/PuertoRico-Cash.pdf

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Pregnant Women in PR SSA_FINAL 01SEP2017