Supporting Statement A

FORMATIVE RESEARCH TO ASSESS PEDIATRIC HEALTHCARE PROVIDERS KNOWLEDGE, ATTITUDES AND PRACTICES AROUND ZIKA VIRUS

OMB # 0920-1154

Supporting Statement A

January 21, 2021

Catlin Green

Epidemiologist

National Center on Birth Defects & Developmental Disabilities

Centers for Disease Control and Prevention

4770 Buford Hwy.

Mailstop E86

Atlanta, GA 30341

Phone 404-498-1462

Table of Contents

Section

A. Justification

1. Circumstances Making the Collection of Information Necessary

2. Purpose and Use of the Information Collection

3. Use of Improved Information Technology and Burden Reduction

4. Efforts to Identify Duplication and Use of Similar Information

5. Impact on Small Businesses or Other Small Entities

6. Consequences of Collecting the Information Less Frequently

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

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

9. Explanation of Any Payment or Gift to Respondents

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

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

12. Estimates of Annualized Burden Hours and Costs

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

14. Annualized Cost to the Federal Government

15. Explanation for Program Changes or Adjustments

16. Plans for Tabulation and Publication and Project Time Schedule

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

18. Exceptions to Certification for Paperwork Reduction Act Submissions

Attachments

• Attachment A - Final AAP Survey Questions

• Attachment B - IRB Exempt Approval Letter

• Attachment C - Survey Cover Letter

• Attachment D - Survey Electronic Cover Letter

• Attachment E - Federal Register Notice

• Attachment F - Part II_Frm Rcsh pf Knowledge Attitudes Practices around Zika Virus

• Attachment G - AAP Survey Incentives

• The goal of this generic information collection request is to enable the American Academy of Pediatrics (AAP) to conduct a survey to delineate pediatrician knowledge, attitudes, and practices specific to Zika virus. The survey objectives mirror those proposed by the CDC in the project plans provided to the AAP. While not generalizable to the national population, the resulting data from the survey will benefit the CDC in its future work with the AAP (and perhaps other associations for clinicians). The survey results will also assist in informing the AAP how to disseminate information and focus educational outreach specific to the Zika virus and perhaps other potential emerging infectious disease threats.

• The methods used to collect the information will include a printed and/or electronic survey (whichever the member participants choose to complete).

• Respondents will include up to 1,600 board-certified pediatricians who are members of the AAP, are not retired, and reside within the United States.

A. JUSTIFICATION

1. Circumstances Making the Collection of Information Necessary

The emergence of the Zika virus and related public health emergency has resulted in a situation where it is believed that infants are not receiving the care they require. Further, AAP pediatrician member awareness of clinical guidance for screening, testing, neuroimaging, reporting, and follow-up regarding Zika virus appears low. The CDC has awarded funding to the AAP to support Zika Response Project activities, and as mentioned, one of the required activities is to conduct a survey to delineate pediatrician knowledge, attitudes, and practices specific to Zika virus.

2. Purpose and Use of Information Collection

As mentioned, the purpose of this survey is to better understand knowledge gaps and barriers that pediatricians face in learning about Zika virus and related clinical recommendations. A secondary area of focus is to explore current sources of trusted information for practitioners, preferences in messaging strategies, and use of technology through which practitioners might wish to receive information in an emergency. It will also be important to learn which types of approaches might be most useful to help pediatricians understand and implement guidance and recommendations during a public health emergency.

While not generalizable to the national population, the survey results will be used to inform ongoing practices and guide future messaging and educational activities to support select pediatricians to care for infants with confirmed or suspected congenital Zika virus. Results will not state any prevalence estimates based on data. Results may be considered by the AAP and the CDC to guide future dissemination of messaging and guidance for Zika response as well as to inform the development of tools to improve communication among provider types and reduce barriers to providing recommended care.

3. Use of Improved Information Technology and Burden Reduction

The selection of the 1,600 AAP pediatrician members who will be asked to complete the survey is computer-generated and is based on the last 3 digits of the member identification numbers, which are randomly assigned. This process ensures that the sample is representative of the AAP member population, that members are from various states/geographical areas, and are only selected to participate in an AAP survey once every 6 years.

The survey is mailed in paper form to the address on file of the selected members. Those members who have not responded within a few weeks will receive additional mailings, up to 7, without the incentive. Additionally, 2 email reminders will be sent (typically coinciding with the second and fourth mailings) containing a link to an electronic version of the survey that respondents can use instead of the paper version. As soon as a respondent returns or completes the survey, either in paper form or electronically, they are taken off the list for future reminders. After 7 rounds of reminders/requests, the survey is concluded.

4. Efforts to Identify Duplication and Use of Similar Information

Information about pediatric healthcare provider knowledge, attitudes, and practices around Zika virus is lacking. Two relevant surveys funded by the CDC, titled the DocStyles survey and the Abt Associates CONUS survey have been conducted, but neither surveyed pediatric healthcare providers. The DocStyles survey focused on obstetric and gynecologic (Ob/Gyn) providers and the Abt Associated CONUS study surveyed a variety of providers (family practice, Ob/Gyn, infectious disease, emergency medicine, women’s health, and certified nurse midwives) but not pediatric providers. Informal needs assessment data from AAP members has been collected by reviewing common clinician inquiries on Zika virus; seeking information from AAP Zika virus experts; compiling questions from calls, webinars, and meetings; and by reviewing top pediatric clinical inquiries received by the CDC.

5. Impact on Small Businesses or Other Small Entities

No small businesses will be involved in this data collection. However, the survey respondents might be pediatricians who work in small office practices, and the demographic information collected in the survey should reveal this.

6. Consequences of Collecting the Information Less Frequently

This request is for a one-time data collection. A survey like this has not yet been conducted by the AAP or the CDC.

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

This request fully complies with the regulation 5 CFR 1320.5.

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

The Federal Register notice was published for this collection on July 18, 2016, Vol. 81, No. 137, pp. 46680. (See Attachment E - Federal Register Notice) No public comments were received.

No other public contacts and opportunities for public comments were received. The following CDC employees were consulted for the development of this request:

Renita Macaluso, Information Collection Review Office

Verita Buie, DrPH, National Center for Health Statistics

9. Explanation of Any Payment or Gift to Respondents

The AAP survey protocol includes providing a two-dollar bill as a survey incentive in the first mailing of the survey. Additional details are provided in GenICRequest - AAP Survey Zika and Attachment G - AAP Survey Incentives.

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

The individual data collection instrument does require respondents to provide identifying or potentially identifying information, but this information is kept secure within the AAP Department of Research and is only used to track which participants have completed the survey (so that each member is not surveyed more than once every 6 years). Data will be reviewed internally by the AAP Department of Research staff, and the CDC will, at no time, have access to any local data that contains identifiers. The CDC will only receive a summary of results. The AAP staff will verify that any individually identifiable information that has been collected during the survey has been removed from information transmitted to or shared with the CDC.

All respondents will be informed that their data will be maintained in a secure manner, and that the data will only be used for the purposes stated in the letter (or e-mail message) that accompanies the survey. Although the identities of respondents may be known to the AAP Department of Research staff through the AAP identification number, the respondents’ identifying information will not be shared outside of the Department of Resource staff or submitted to CDC. Only authorized project staff will be allowed to have access to study information (whether identifiable or not) and all information will be kept in a locked cabinet and/or locked office with restricted access, or the information password protected files in secure computers.

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

The IRB review and approval has been sought through the AAP Institutional Review Board. The survey was declared to be exempt from IRB review. The IRB letter of approval is included as Attachment B - IRB Exempt Approval Letter.

A.12. Estimates of Annualized Burden Hours and Costs

The annualized response burden is estimated at 533 hours.

Exhibit A.12.A Annualized Burden Hours

Type of Respondent	Form Name	Number of Respondents	Number of Responses per Respondent	Average Hours Per Response	Total Response Burden (Hours)
Pediatric health care practitioners, AAP members, non-retired, U.S. based	AAP Zika Virus Survey	1,600	1	20/60	533 hours
Total		1,600	1	20/60	533 hours

A.12.B Estimated Annualized Costs

Collections by health jurisdictions are generally funded through cooperative grants and these will be noted in the specific collection requests. The annualized cost to the respondent is segmented accordingly in Exhibit A.12.B.

The United States Department of Labor, Bureau of Labor Statistics May, 2015 http://www.bls.gov/oes/current/oes291069.htm.) data were used to estimate the hourly wage rate for the general public and for private providers for the purpose of this generic request. Each project will have cost specific to the category of the respondents. Because it is not known what the wage rate category will be appropriate for the specific projects (or even whether they will be employed at all), the figure of $20.00 per hour was used as an estimate of average hourly wage across the country.

Exhibit A.12.B. Annualized Cost to Respondents

Activity	Total Burden Hours	Hourly Wage Rate	Total Respondent Cost
Data collection	533	$20	$10,660

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

There are no other costs to respondents or record keepers.

A.14. Annualized Costs to the Government

The CDC provides, through Supplemental Funding to a Cooperative Agreement to the AAP, funding for time for an AAP Department of Research Survey Manager to work with a volunteer AAP Zika Expert Working Group, printing, postage, incentive, and supplies related to mailing the survey to 1,600 randomly selected members. See the GenICRequest - AAP Survey Zika for a detailed budget.

Expense Type	Expense Explanation	Annual Costs (dollars)
Cooperative Agreement or Contract	Cooperative Agreements, Task orders, or Contracts for implementation or information management	$79,014.66
	TOTAL COST TO THE GOVERNMENT	$79,014.66

A.15. Explanation for Program Changes or Adjustments

This is a new generic information collection.

A.16. Plans for Tabulation and Publication and Project Time Schedule

Data collection will begin in February or March 2018, immediately after OMB approval is received. Below is the estimated project schedule based on assumed start of February 2018:

October 2017 – IRB and OMB submissions and approvals

February 2018 – Begin fielding survey

February to May 2018 – Continue to field survey (7 rounds of mailings/e-mails)

June 2018 – Analize and summarize date, with the intention to write an article for potential publication and disseminate findings

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

The display of the OMB expiration date is not inappropriate.

A.18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

REFERENCE

Office of Management and Budget, Statistical Policy Directive No. 2: Standards and Guidelines for Statistical Surveys; Addendum: Standards and Guidelines for Cognitive Interviews. Published in the Federal Register, October 12, 2016, vol. 81, no. 197, pp. 70586.