Supporting Statement A for Request for Emergency Clearance:
NATIONAL CENTER FOR HEALTH STATISTICS RESEARCH AND DEVELOPMENT SURVEY
OMB No. 0920-XXXX
Expiration Date: XX/XX/XXXX
Contact Information:
Paul J Scanlon Jr, PhD.
Senior Behavioral Scientist
Collaborating Center for Questionnaire Design and Evaluation Research
Division of Research and Methodology
National Center for Health Statistics/CDC
3311 Toledo Road
Hyattsville, MD 20782
301-458-4649
January 28, 2021
Table of Contents
A. Justification
A.1. Circumstance Making the Collection of Information Necessary 5
A.2. Purpose and Use of Information Collection 5
A.3. Use of Improved Information Technology and Burden Reduction 8
A.4. Efforts to Identify Duplication and Use of Similar Information 8
A.5. Impact on Small Businesses or Other Small Entities 9
A.6. Consequences of Collecting the Information Less Frequently 9
A.7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 9
A.8. Comments in Response to the Federal Register Notice and
Efforts to Consult Outside the Agency 9
A.9. Explanation of Any Payment or Gift to Respondents 10
A.10. Protection of the Privacy and Confidentiality of Information Provided
by Respondents…………………………………………….. 11
A.11. Institutional Review Board (IRB) and Justification for Sensitive Questions 16
A.12. Estimates of Annualized Burden Hours and Costs 17
A.13. Estimates of Other Total Annual Cost Burden to Respondents
or Record Keepers 18
A.14. Annualized Cost to the Federal Government 18
A.15. Explanation for Program Changes or Adjustments 19
A.16. Plans for Tabulation and Publication and Project Time Schedule 19
A.17. Reason(s) Display of OMB Expiration Date in Inappropriate 19
A.18. Exceptions to Certification for Paperwork Reduction Act Submissions 19
LIST OF ATTACHMENTS
Attachment A - Pub Health Serv Act
Attachment B - Intro Screen and Questionnaire
Attachment C - NORC CIPESA Protection Plan
Attachment D - NCHS Non-Disclosure Affidavit for NORC Organization Staff working on RANDS
Attachment E - NCHS ERB Approval Notice
Attachment F - Abstracts of Previous RANDS Research on Estimation and Calibration
Attachment G - RANDS during COVID-19 Variable Crosswalk, Uses, and Power Calculation
Attachment H - Health and Health Care Access Questions Across Federal Surveys During COVID-19
Attachment I - NORC Field Report for RANDS during COVID-19, Round 1
Attachment J - NORC Field Report for RANDS during COVID-19, Round 2
Supporting Statement A
Executive Summary
The National Center for Health Statistics’ (NCHS) requests emergency approval for six months to continue conducting the National Center for Health Statistics’ Research and Development Survey (RANDS) during COVID-19. The overall goal of the broader NCHS RANDS project is to leverage commercially-created and maintained survey panels to supplement and expand NCHS’ methodological research. Furthermore, RANDS during COVID-19 will allow NCHS to quickly obtain and disseminate information about selected population health characteristics during the ongoing Coronavirus pandemic and to provide documentation supporting the validity of pandemic-related survey questions, including questions, such as those on telehealth access and use, that will continue to be important for public health after the pandemic.
Two rounds of RANDS during COVID-19 were approved on an emergency basis in May 2020 (OMB No. 0920-1298, expiration: 11/30/2020); prior to this, RANDS has been conducted under the Collaborating Center for Questionnaire Design and Evaluation Research’s (CCQDER) Generic Clearance (OMB No. 0920-0222, expiration: 8/31/2021). We are now requesting a new emergency clearance for this data collection. In addition to continuing the methodological objectives of previous RANDS (including the previous two rounds of RANDS during COVID-19), given the ongoing demands for timely information related to the COVID-19 pandemic, NCHS proposes to take advantage of past methodological advancements of the RANDS program to use the survey to provide information on selected population health characteristics related to COVID-19. In particular, this third round of RANDS during COVID-19 will allow NCHS to release a new set of experimental estimates on three important areas: work loss due to illness with COVID-19, telemedicine use and access, and missed care due to the pandemic. In addition, this round of RANDS will be interpreted in the context of other information collections during the COVID-19 response, particularly the Census Bureau’s Household Pulse Survey during the COVID-19 Epidemic (referred to throughout as the “Census Pulse Survey”, OMB No. 0607-1013), which collects weekly data on temporal and geographic trends.
Specifically, this emergency information collection request has two purposes: (a) generation of data that can help explain health-related experiences of the US population during the pandemic and (b) continuation of developmental survey methods research. These purposes encompass three distinct, but related, activities:
Experimental Estimation Production: The RANDS-COVID-19 survey, which will be conducted by NORC using their commercially-available probability Amerispeak survey panel and whose data will be calibrated to the National Health Interview Survey (NHIS) based on previous NCHS RANDS research findings.
Estimation Research: Continued research into the similarities, differences, and potential for calibration between RANDS and other NCHS and federal surveys, including the NHIS, the National Survey of Family Growth (NSFG), and the Census Pulse Survey.
Measurement Research: Continue the evaluation and validation of COVID-19- other health-related survey questions via methods such as web probing and experimental design.
The subject matter covered in RANDS during COVID-19 will primarily focus on health related population characteristics, while the questionnaire will also include items to be used in the calibration to NHIS, to compare to data collected from the NHIS, to compare to other COVID-19 related data collections that do not focus on health, and for question evaluation. RANDS is designed to include a set of health questions from the NHIS for the purpose of calibration to increase alignment, and reduce differences due to differential response, between sources associated with heath. Further, RANDS during COVID-19 includes questions included on other Federal COVID-19 surveys for ‘cross-walking’ and triangulation of information among sources. This triangulation will allow NCHS to make more robust and detailed interpretations of the items shared across the surveys.
For the measurement research portion of this request, CCQDER staff will use both experimental designs and set cognitive probes to examine questionnaire concepts (such as reference period utility) and the construct validity of survey items. Alongside a set of cognitive interviews approved previously, this measurement error work will provide some of the first high-quality qualitative insights into how survey items related to the novel Coronavirus and COVID-19 function. In particular, the findings from the measurement error research will continue to inform the design of planned Coronavirus-related questions for the NHIS and the National Health and Nutrition Examination Survey (NHANES) as well as a planned re-design of the NSFG.
To administer the survey, NCHS has contracted with NORC, a commercial firm that maintains its own proprietary survey panel known commercially as the AmeriSpeak Panel. Using this platform, NCHS will conduct a survey to collect data about the demographic, health, and behavioral characteristics of the sample during the COVID-19 pandemic for the purpose of generating data that can help explain health-related experiences of the US population during the pandemic. The results from this probability sampled panel will be used for the purpose of generating data that can help explain health-related experiences of the US population during the pandemic. For the purpose of continuing our survey methods research, we plan to build on work already done with previous rounds of RANDS (including the previous rounds of RANDS during COVID-19) on combining information from high quality in-person interview surveys and commercial survey panels. Furthermore, NCHS will conduct sub-group analyses in an effort to understand not only health outcome and access disparities but differences in survey response across groups as well.
As explained in detail in Part B, NCHS recognizes that even recruited panels’ data quality are not equivalent to the data quality from its traditional survey systems (such as the NHIS and NHANES). When initially developed, NCHS did not intend to use RANDS to create independent official statistics, but rather to develop methods to calibrate web based surveys using the higher quality information obtained from other NCHS data collections in order to increase the content of information obtained as well as the sample size available for some analysis. RANDS was also intended to increase our understanding of how some health outcomes, behaviors, and attitudes are related and how these relationships might differ across populations. Finally, RANDS also provides a platform for expanding our question evaluation program.
However, building on what we have learned through our work with RANDS and the need for timely information on COVID-19 when other data collection systems are not able to operate at all or efficiently, we expanded the objectives of RANDS to provide substantive estimates of health and health care characteristics related to the COVID-19 pandemic. There is need for rapid information about the health of the population during the COVID-19 pandemic and response that can only be obtained through surveys, and RANDS is able to provide this information given the design of the survey and the methodological insights obtained from past RANDS rounds, including the previous rounds of RANDS during COVID-19. Therefore, one of our purposes is to use RANDS data—calibrated to the NHIS and in conjunction with information known about the error structure of the resulting data—to generate data that can continue to help explain health-related experiences of the US population during the pandemic. As we have done with the previously collected rounds of RANDS during COVID-19, technical material accompanying all data disseminations will describe the limitations of the data due to coverage and sample design and methods used for calibration and estimation and all estimates will clearly be labeled ‘experimental’ throughout the associated documentation1. The presentation of RANDS data will be done in coordination with information from NCHS’ traditional information collections when those data become available and in coordination with other federal data, when appropriate. Data collections across all NCHS surveys and with other Federal data collections are being coordinated to achieve this end. In particular, there is a close synergistic relationship between the RANDS, the NHIS, the Census Pulse Survey, the Current Population Survey (CPS), the Medicare Current Beneficiary Survey (MCBS), and BLS’ National Longitudinal Survey of Youth 1979 (NLSY79).
This ICR is time-sensitive and is therefore being requested under emergency procedures. The United States is continuing to experience a pandemic due to the novel Coronavirus, and CDC requires timely information about the public’s experiences with the virus, the COVID-19 disease, and the pandemic response. The information provided by this data collection will allow CDC and NCHS to target its ongoing public communication and to collect valid data in future information collections.
NCHS’ Research and Development Survey
A new six-month OMB clearance is being requested for the Centers for Disease Control and Prevention’s (CDC) National Center for Health Statistics’ (NCHS) Research and Development Survey (RANDS). Since COVID-19 has resulted in a public health crisis, NCHS is requesting an emergency clearance. Data related to this pandemic is needed sooner than a regular OMB approval can be obtained; we do not want to delay the urgency of the needed data.
This information collection request encompasses the collection of RANDS data via NORC’s statistically sampled AmeriSpeak for the primary purpose of generating data that can help explain health-related experiences of the US population during the pandemic and to continue our methods research on the appropriate use of panels and question response patterns for COVID-19 related survey questions. This work will be conducted by the staff of NCHS’ Division of Research and Methodology and its designated agents.
A. JUSTIFICATION
1. Circumstances Making the Collection of Information Necessary
The United States is currently suffering from a pandemic of a novel Coronavirus (SARS-CoV-2) that by some estimates has infected over 13,142,000 Americans and led to over 265,000 deaths in the United States as of November 30, 20202. On January 31, 2020 the Secretary of Health and Human Services determined that this pandemic was a public health emergency3. The Centers for Disease Control and Prevention, of which the National Center for Health Statistics is a component, is one of the agencies responsible for the federal response to this pandemic.
One of the main public health responses to this pandemic is an increase in social distancing and associated “stay-at-home” orders whereby Americans are asked to limit their physical interactions with others from outside their household and places of businesses are closed and people are working from home. As a result, the collection of federal survey data that use face-to-face modes of collection, have slowed or halted. NCHS’ largest household survey, the NHIS, has been fielded throughout the pandemic, its sample and data collection methodology changed (from mostly in-person interviews to only telephone interviews); furthermore, NHIS’ results from the pandemic period are not expected until early 2021. NCHS’ other main household survey, the NHANES, is out of the field entirely (and is currently estimated to return to the field in the second half of 2021). However, data on health outcomes and health care access associated with the pandemic are vital. NCHS’ Research and Development Survey provides NCHS and CDC with an opportunity to collect this necessary data in a timely way via survey modes unaffected by social distancing.
Data collection for this project is authorized under 42 U.S.C. 242k (Section 306 of the Public Health Service Act). A copy of the legislation is provided in Attachment A. CDC is requesting emergency clearance with the understanding that clearance is limited to six-months.
2. Purpose and Use of Information Collection
This information collection requests approval to conduct a follow-up round of data collection to the initial two rounds of the RANDS during COVID-19 survey (0920-1298, expiration: 11/30/2020). As with the previous rounds, this follow-up round is a panel-based survey that will include a set of survey responses collected from NORC’s AmeriSpeak Panel. These data will be used not only for the purpose of continuing NCHS’ developmental survey methods research via the RANDS program, but also to contribute to CDC’s ongoing surveillance of the COVID-19 pandemic and to generate data that can help explain health-related experiences of the United States population during this period. In the first instance, the survey will be used to continue DRM’s long-term research that explores whether or not, and how, commercial survey panels may complement NCHS’ existing survey systems. In the second instance, the survey data will both contribute CDC’s ongoing surveillance of the COVID-19 pandemic and generate data that about health-related experiences of the US population during the pandemic. Additionally, for a limited set of variables (see Appendix M), NCHS will release experimental estimates.
This current proposal is for one new round of data collection using NORC’s statistically sampled AmeriSpeak Panel4. The round will be conducted after OMB approval is obtained in late Fall of 2020, approximately four months following the second round of RANDS during COVID-19, which was fielded in July and August of 2020. NCHS will contract with NORC to obtain 5,700 complete responses to the survey. The contract with NORC will specify a number of complete responses and not an initial sample size—NORC will be responsible for providing the specified number of completes regardless of the response rate to participate in the surveys. Of this sample, 1,700 responses will be obtained via telephone interview and the other 4,000 responses will be obtained via web self-response. This sample represents a telephone oversample and will permit NCHS to continue its methodological exploration of the differences in the sample composition, health outcome, and survey responses differences and coverage effects related to survey mode in commercial survey panels.
The proposed questionnaire is found in Attachment B. Following the analysis of an initial round of cognitive interviews conducted on NCHS staff, the web probes administered in the first two round of RANDS during COVID-19, and the full iterative set of cognitive interviews conducted on members of the public, some questions have been modified for this third round of the survey. Additionally, in consultation with other areas of NCHS, other questions have been added or removed in order to provide NCHS’ programs with the measurement information they need to collect and interpret coronavirus-related information.
Methodological Component
As with previous rounds of RANDS (all of which have been collected previously under CCQDER’s generic clearance, OMB control number 0920-0222, current expiration: 8/31/2021, with the expectation of the previous two rounds of RANDS during COVID-19 that were approved on an emergency basis with OMB Control number 0920-1298, expiration: 11/30/2020), NCHS developed RANDS during COVID-19 with a methodological component that will allow the agency to continue the long process of examining whether or not, and how, commercial survey panels may be integrated into NCHS’ existing survey systems. On one hand, this includes measurement research activities, such as the exploring the construct validity of proposed or new NCHS questions, the difference in response to alternate forms of a question, and how quantitative techniques (such as experimental design and closed-ended web probing) can be best integrated with qualitative techniques (such as cognitive interviewing and open-ended web probing), and the impact of mode on survey response. On the other hand, DRM will use this data to continue its estimation research activities understanding the properties of commercial web panel data relative to NCHS core survey data and exploring the optimal ways of combing commercial web panel data with data from NCHS’ traditional, high-quality household surveys (such as the NHIS and NHANES).
In terms of measurement research, the third round of RANDS during COVID-19 will focus on three major areas. First, a set of COVID-19-related NHIS items will be evaluated using web probes. Secondly, a CCQDER-developed set of vaccine hesitancy questions have been adapted to ask specifically about the COVID-19 vaccine. While NCIRD and other areas of CDC have already begun planning on using these to explore hesitancy related to the COVID-19 vaccine, RANDS during COVID-19 will be used to explore the validity of these items for this new purpose. These items do not match another set of vaccine hesitancy questions currently being administered as part of the Census Household Pulse survey, as CCQDER is interested specifically in whether or not this particular set of questions can be adapted successfully. Third, a set of items on social distancing and mask usage (currently being run on an opt-in survey by CDC’s COVID-19 response group) are being included. Not only will CCQDER use RANDS during COVID-19 to validate these specific items, but will use web probes to continue research into how different population subgroups comprehend coronavirus pandemic-related terms differently.
It is important to note that both aspects of RANDS’ methodological component allow NCHS to explore the underlying social inequities that impact how surveys themselves function. These differences in how survey methods work across subgroups—including racial, ethnic, geographic, educational, and age groups—can obviously lead to differences in survey estimates due to either sampling or non-sampling biases5. NCHS’ work in identifying these underlying differences will allow the Center, and the Federal Statistical System as a whole, to develop mitigation strategies and eventually lead to more valid understandings of inequities between groups in our society.
As an example, NCHS has used web probing methodology to explore whether or not respondents with different levels of educational attainment comprehend questions differently. For instance, using data from RANDS 2, NCHS was able to show that mis-interpretation and false positives in components of the K6 Psychological Distress Scale was significantly more common among respondents with lower levels of education6. More recently, using the first rounds of RANDS during COVID-19 data, NCHS is currently exploring how different subgroups understand coronavirus-related terms (such as “quarantine” and “pandemic”). While the analysis is not complete as of the submission of this package, NCHS will make a DRM research memo available to OMB once it is available.
The Center plans on continuing this line of research in the third round of RANDS during COVID-19, with a particular emphasis on the interpretation of social behaviors that have emerged in reaction to the pandemic such as mask wearing and social distancing. These analysis will permit policy makers to better understand whether the underlying inequities in the spread and outcome of COVID-19 are potentially made worse by how particular groups actually interpret some of the public health recommendations designed to lessen the spread and impact of the disease.
Surveillance Component
While one purpose of this information collection is to discover new, and to improve existing, methods that will increase data quality in the midst of declining response rates and increased costs, the other purpose of RANDS during COVID-19 is to focus on providing NCHS and CDC with information on American’s experiences and health outcomes related to the ongoing Coronavirus pandemic. These data will then be used by NCHS and CDC to inform policy and communication efforts as well as future surveys and studies. Given the current pandemic and the continuing limitations placed on NCHS’ other data collections, RANDS will provide NCHS and CDC with timely estimates of COVID-19-related concepts (such as healthcare access, psychological distress, chronic conditions, health behaviors, COVID-19 testing and health care received in relation to COVID-19, and disease prevention behaviors during this period).
The information obtained from RANDS will be used by NCHS and CDC for the purpose of generating data about health-related experiences of the US population during the pandemic. These data can be used for informing future data collections, policy decisions, and communication strategies. As the sample underlying RANDS is not of the same quality as those in NCHS’ large population health data collections, any data products will include explicit language labeling estimates as ‘experimental’ and explaining the resulting limitations and their potential impacts on data quality and accuracy.
Furthermore, dissemination and interpretation of RANDS will be coordinated with COVID-19 data from NCHS’s traditional data collections when they become available and with other related health data, when appropriate. In particular, RANDS during COVID-19 includes a small number of questions that are being fielded (or are planned to be fielded) by other Federal information collections, including the CPS, the Census Pulse Survey, and the NHIS. As shown in Attachment G (and with the notable exception of the extensive overlap with the NHIS, which is largely due to RANDS’ planned calibration and measurement error research efforts), most of these shared variables relate to RANDS during COVID-19’s primary conceptual focus of health care access. Doing so will allow NCHS to triangulate responses across all of these surveys, allowing it a more robust and detailed examination of health care access than if this was not possible. A more detailed explanation of what each survey contributes on its own, and in triangulation with RANDS, is presented in Attachment H. Briefly:
The Census Pulse Survey and CPS have collected basic information of both health insurance coverage and receipt or non-receipt of non-coronavirus health care in the last 4 weeks due to the Coronavirus pandemic. Given the broad focus of the Census Pulse Survey, and the economic focus of the CPS, NCHS also expects to be able to get information about how health insurance and receipt/non-receipt of non-Coronavirus health care relate to other non-health variables—in particular employment and economic status. By triangulating these results with those from RANDS during COVID-19, NCHS believes that it can gain insight into potential relationships between economic and health-related barriers to health care.
RANDS uses the NHIS as it major source questionnaire, so a large number of items are shared across the two surveys. The largest proportion of this overlap is due to RANDS during COVID-19’s alignment and calibration plans, wherein NCHS can investigate the overall similarity of the samples and to then correct for some differences using calibrated weights (see Attachment G for the list of “alignment” and “calibration” variables).
Other overlapping variables between these two surveys relate to RANDS’ estimation goals and will provide NCHS with the ability to explore related covariates—for instance whether or not a respondent has a usual place of care. Shared health care access questions will also provide NCHS with a baseline when considering the estimates RANDS will produce during the COVID-19 pandemic. It should be noted that RANDS will not ask the exact version of the non-receipt of non-Coronavirus health care question that NHIS is planning, but rather will ask the CPS/Census Pulse Survey version. There are two reasons for this. First, given that RANDS has a large number of items that overlap with NHIS, but not with CPS or the Census Pulse Survey, matching the wording with the version found on the latter two will allow triangulation to those surveys. Second, while NHIS began collecting data from its Coronavirus-related questions in July of 2020; at the point the first round of RANDS during COVID-19 was fielded, only the CPS and the Census Pulse Survey were being fielded. The decision was therefore made to align this construct with the latter two surveys; in order to allow for trend analysis, we plan on keeping this same version in the third round even though the NHIS is currently collecting data using its version of the question.
Finally, NHIS staff have implemented, and are currently planning some future, questionnaire changes due to COVID-19. The results from the measurement error research component of RANDS during COVID-19 (see Attachment G for those questions related to this component) will help evaluate these items and assist NHIS in finalizing these changes.
RANDS during COVID-19 data will inform methodology, policy, and communications decisions by NCHS and CDC related to the Coronavirus pandemic going forward. While the underlying sample quality has known limitations, in combination with calibration methods that NCHS has developed based on previous rounds of RANDS and with coordination with other data being collected and released, we believe that the data quality will be sufficiently fit for our purposes.
3. Use of Improved Information Technology and Burden Reduction
RANDS during COVID-19
RANDS during COVID-19 will use information technology to reduce burden. It will be conducted across two modes: self-response web and interviewer-administrated telephone. About 77% of the sample will complete their surveys online using NORC’s proprietary survey software. Among other features, this software skips respondents’ past questions for which they do not qualify and allows for the embedding of help text. The 23% of AmeriSpeak panelists who will receive the phone survey will use a CATI questionnaire, where again they will be skipped out of questions for which they do not qualify.
4. Efforts to Identify Duplication and Use of Similar Information
Given the current nature of the COVID-19 pandemic, there are limited data from large ongoing population health surveys about the novel Coronavirus pandemic and its health and social implications. Some private polling and survey firms have collected COVID-19-related data, but these do not serve NCHS’ and CDC’s purposes given a) the low quality of these typically-RDD or opt-in surveys and b) the fact that NCHS cannot access both the frame and record-level data that will permit it to create its own estimates that comport to our scientific rigor and fit our purposes.
Although there are other federal data collections obtaining COVID-19 data using methods similar to ours, such as the Census Pulse Survey, RANDS differs from other collections in several important ways.
First, the focus of RANDS during COVID-19 is on health so a wider range of health information on multiple constructs will be obtained compared to other more general surveys. In particular, the Census Pulse Survey (on which NCHS is a collaborator) is obtaining limited information in a large number of domains using a sample large enough to get information for geographic areas. However, this Census Bureau-led survey only includes a small set of health questions in the final questionnaire approved by OMB. While most of these questions will also be fielded in the RANDS during COVID-19 (with some minor differences in question text due to mode and reference period), the RANDS’ questionnaire includes dimensions of health not found in the Census Pulse survey. By including a subset of the RANDS questions in the Census Pulse survey, we will be able to crosswalk between the two data collections; gaining breadth from the Census Pulse survey, but greater depth from RANDS. The longitudinal collection of information for the same participants will allow us to describe changes in health care access, behaviors, and attitudes during this rapidly changing environment.
Second, while NHIS now includes COVID-19 questions and its wide range of health questions, there are important differences between the two sources. The RANDS data is able to provide more timely information relative to other NCHS population health surveys, including NHIS. This third round is being conducted in order to examine trends across the constructs for which NCHS has released experimental estimates and therefore characterize changes in health during this period. The RANDS program has experience leveraging the strength of the NHIS to improve and evaluate its estimates and includes NHIS questions specifically for this purpose in each round.
Third, we are building on an established relationship with NORC and obtaining data (largely) using methods previously determined by us. This experience will allow NCHS to quickly analyze the RANDS during COVID-19 data in a way that acknowledges and compensates for the survey design.
Lastly, as has been the case with previous rounds of RANDS, data from the third round of RANDS during COVID-19 will be used to inform the design of other NCHS (and federal statistical system) survey questionnaires. In particular, since this will be one of the only NCHS surveys collecting information on the public’s interpretations and understandings of concepts around the Coronavirus pandemic, the findings from both components of this information collection request will provide other parts CDC (as well as other agencies) best practices for collecting data about this crisis.
5. Impact on Small Businesses and Other Small Entities
Information collection for RANDS does not involve small businesses or other small entities.
6. Consequences of Collecting the Information Less Frequently
The information that will be collected under this request is about an ongoing public health emergency that has impacted many aspects of American life, including healthcare access and health outcomes. The plan is to conduct a third round of the RANDS during COVID-19 survey approximately three months following the conclusion of the previously approved second round. By not collecting this proposed third round, or by collecting it at a much later date, NCHS will be unable to understand the in-the-moment changes to health outcomes, access, behaviors, as well as changes in how the public understands key concepts related to the pandemic.
7. Special Circumstances Relating to Guidelines of 5 CFR 1320.5
There are no special circumstances.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agencies
This is an emergency request, and a Federal Register Notice will be published after OMB approval.
A Federal Register Notice was published for the previous two rounds of interviews on August 20, 2020 (Vol. 85, No. 162, pp. 51437-8).
Consultants outside of CDC:
The following individuals have been consulted about the RANDS during COVID-19:
Debra Reed-Gillette
Director, Medicare Current Beneficiary Survey
Centers for Medicare & Medicaid Services
(410) 786-5525
Jenny Hunter Childs
Assistant Center Chief, Center for Behavioral Science Methods
United States Census Bureau
(301) 763-4927
Keenan Dworak-Fisher
Economist
Bureau of Labor Statistics
Consultants within CDC:
The following individuals within NCHS have been consulted about RANDS during COVID-19:
Jessica Graber
Division of Health and Nutrition Examination Surveys
3311 Toledo Road
Hyattsville, MD 20782
(301) 458-4258
Stephen Blumberg
Division of Health Interview Statistics
3311 Toledo Road
Hyattsville, MD 20782
(301) 458-4107
9. Explanation of Any Payment or Gift to Respondents
RANDS during COVID-19
AmeriSpeak respondents will not be paid for participating in RANDS during COVID-19.
10. Protection
of the Privacy and Confidentiality of Information Provided by
Respondents
The NCHS Privacy Act Coordinator has reviewed this request and has determined that the Privacy Act is applicable. The related System of Records Notice is 09-20-0164 Health and Demographic Surveys Conducted in Probability Samples of the U.S. Population.
A Privacy Impact Assessment was submitted on October 10, 2019. CCQDER and DRM continue to collect, on a confidential basis, data needed in order to conduct CCQDER and DRM studies. For the RANDS during COVID-19 survey, the process of informing respondents of the procedures used to keep information confidential respondents begins with language explicating the voluntary nature of the survey and providing the legal basis and confidentiality assurance on the initial screen (shown in Attachment B), and will asked to review it before beginning the survey on the next screen. This information includes all elements of informed consent, including the purpose of the data collection, the voluntary nature of the study, , and the effect upon the respondent for terminating the interview at any time.
In the activity requested in this ICR, confidentiality provided to respondents is assured by adherence to Section 308(d) of the Public Health Service Act (42 U.S.C. 242m) which states:
"No information, if an establishment or person supplying the information or described in it is identifiable, obtained in the course of activities undertaken or supported under section...306 (NCHS legislation),...may be used for any purpose other than the purpose for which it was supplied unless such establishment or person has consented (as determined under regulations of the Secretary) to its use for such other purpose and (1) in the case of information obtained in the course of health statistical or epidemiological activities under section...306, such information may not be published or released in other form if the particular establishment or person supplying the information or described in it is identifiable unless such establishment or person has consented (as determined under regulations of the Secretary) to its publication or release in other form,..."
In addition, legislation covering confidentiality is provided according to section 513 of the Confidential Information Protection and Statistical Efficiency Act or CIPSEA, which states:
“Whoever, being an officer, employee, or agent of an agency acquiring information for exclusively statistical purposes, having taken and subscribed the oath of office, or having sworn to observe the limitations imposed by section 512, comes into possession of such information by reason of his or her being an officer, employee, or agent and, knowing that the disclosure of the specific information is prohibited under the provisions of this title, willfully discloses the information in any manner to a person or agency not entitled to receive it, shall be guilty of a class E felony and imprisoned for not more than 5 years, or fined not more than $250,000, or both.”
RANDS during COVID-19 Information in Identifiable Form
NORC has access to Information in Identifiable Form (IIF) for their panel membership, including information such as name, date of birth, mailing address, and phone numbers. They collect this information in order to maintain their propriety panel. However, no direct IIF is associated with the RANDS data collection, and no direct personally identifiable information is transmitted to NCHS from NORC’s servers. NORC has extensive cyber and physical security in place, including a CIPSEA Information Protection Plan approved by the NCHS Confidentiality Officer and the NCHS Information Systems Security Officer (Attachment C), in order to protect both the security of the front-end survey interface and the back-end storage of the survey’s data. In order to comply with this information protection plan, a sample from the panels is pulled from NORC’s server and placed on a separate server share. At this point, all direct identifiers are removed and NORC is unable to directly link RANDS information to individual AmeriSpeak panelists. Additionally, as contractors to NCHS, all NORC employees working on the RANDS during COVID-19 will complete NCHS confidentiality training, sign the NCHS affidavit of nondisclosure (see Attachment D), and will be NCHS designated agents via a Designated Agent Agreement between NORC and NCHS.
While no direct PII will be transmitted to NCHS from NORC, some IIF will be collected in RANDS and securely sent to NCHS as part of the final survey files. All of these items have been routinely approved and collected in the past for other NCHS information collections. The identifiable information includes:
Date of birth
State/Territory
Medical information
General Privacy and Confidentiality Protection Procedures for RANDS during COVID-19
The collection of information in identifiable form during activities encompassed by this ICR requires strong measures to ensure that private information is not disclosed in a breach of confidentiality. Only those NCHS employees, those specially designated agents (including NORC staff), and research partners who must use the personal information for a specific purpose can use such data.
As noted above, all NCHS employees as well as all contract staff, receive appropriate training and sign a “Nondisclosure Statement.” Staff from collaborating agencies are also required to sign this statement, and members of outside agencies are required to enter into a more formal agreement with NCHS. Everyone else who uses RANDS data can do so only after all identifiable information is removed (as described below). In addition, the Cybersecurity Act of 2015 permits monitoring information systems for the purpose of protecting a network from hacking, denial of service attacks and other security vulnerabilities7. Monitoring under the Cybersecurity Act may be done by a system owner or another entity the system owner allows to monitor its network and operate defensive measures on its behalf. The software used for monitoring may scan information that is transiting, stored on, or processed by the system. If the information triggers a cyber threat indicator, the information may be intercepted and reviewed for cyber threats. The cyber threat indicator or defensive measure taken to remove the threat may be shared with others only after any information not directly related to a cybersecurity threat has been removed. In addition, sharing of information can occur only after removal of personal information of a specific individual or information that identifies a specific individual.
It is NCHS policy to make RANDS data available via public use data files to the scientific community. Publicly released data sets will be available indefinitely on the NCHS website. A concerted effort is made to avoid any disclosures that may allow a researcher to go back and find individuals in the general population. To this end, prior to their release, the RANDS data files will be reviewed by the NCHS Disclosure Review Board to evaluate tabulations of data estimates along with the survey methods in order to determine where disclosure risks might arise and how to minimize them. Several techniques are used to minimize these risks, including collapsing categories, top and bottom coding, adding noise to variables, removing detailed geographic information that may allow someone to identify individuals in the general population, along with other statistically sound means. Researchers wishing to conduct analysis on variables not available in the public use data files may submit a research proposal to use the NCHS Research Data Center8. As is currently the case for RANDS during COVID-19 files available via the RDC, there is a note explaining the purposes of these data collections that links to the limitations statement in the RANDS during COVID-19 technical notes.
The CIPSEA legislation authorizes the designation of agents (“designated agents” or “agents”) to perform statistical activities on behalf of an agency. These agents function under the supervision of the agency’s employees and are subject to the same provisions of law with regard to confidentiality as an agency’s employees. A Designated Agent Agreement between the agency and the designated agents (e.g. contractors) must be executed before the agents can acquire information for the agency for exclusively statistical purposes under a pledge of confidentiality. This requirement is outlined in an OMB Notice, published in the Federal Register on June 15, 2007, entitled “Implementation Guidance for Title V of the E-Government Act, Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA).” Additionally, the agents (contractors) will be required to complete the NCHS Confidentiality Training (https://www.cdc.gov/nchs/training/confidentiality/training/), submit a certificate of completion, and sign a pledge to maintain confidentiality (Nondisclosure Affidavit; see Attachment D) prior to completing work. If the contractor hires subcontractors to complete work, the subcontractors must adhere to the same confidentiality and security requirements as NCHS staff and contractors.
11. Institutional Review Board (IRB) and Justification for Sensitive Questions
This research is being conducted under protocol #2016-16 Laboratory Based Questionnaire Design (CCQDER), which was approved by the NCHS Research Ethics Review Board on October 25, 2019 (Attachment E).
Given the fact that RANDS during COVID-19 is designed to survey the public about an ongoing pandemic that has not only affected day-to-day life in the United States, but also lead to a large number of deaths, some of the survey’s topics may include potentially sensitive questions for some respondents. However, the potential sensitivity of questions was an evaluation criterion in determining content of the survey. The multi-purpose nature of the RANDS makes it necessary to exclude topics so sensitive that they may interfere with participation. No topics that have been deemed to be universally or extremely sensitive have been included in the questionnaire (Attachment B).
In the informed consent procedure, respondents are advised of the voluntary nature of their participation in the survey or any of its components. Sample persons are informed that they can choose not to answer any questions they do not wish to answer and that they may stop the interview at any time.
12. Estimates of Annualized Burden hours and costs:
The estimated overall average annual burden for 2020 is 1,734 hours. This project is not expected to extend beyond 2020. Any future modification that might impact the instruments and/or burden estimates will be submitted as a non-substantive change request for OMB review, as applicable.
Estimated Annualized Burden Table
Types of Respondents |
Form Name |
Number of Participants |
Number of Responses/ Participant |
Average hours per response |
Response Burden (in hours) |
Individuals or households |
RANDS during Covid Round 3 |
5,200 |
1 |
20/60 |
1,734 |
Total |
|
5,200 |
|
|
1,734 |
Estimated Annualized Burden Costs to Respondents.
The average annual response burden cost for the CCQDER is estimated to be $41,373.24. The hourly wage estimate is based on the Bureau of Labor Statistics May 2016 National Occupational Employment and Wage Estimates (http://www.bls.gov/oes/current/oes_nat.htm). There is no cost to respondents other than their time to participate.
Type of Respondent |
Form Name |
Total Burden Hours |
Hourly Wage Rate |
Total Respondent Costs |
Individuals or households |
RANDS during Covid Round 3 |
1,734 |
$23.86 |
$41,373.24 |
Total |
|
|
|
$41,373.24 |
13. Estimates of Other Total Annual Cost Burden to Respondents and Record keepers
None.
14. Annualized Costs to the Federal Government
The estimated annualized cost to the federal government for the activities outlined in this information collection request is $384,281.57.
Expense |
Cost |
RANDS NORC Contract |
$305,600.00 |
RANDS Planning/Analysis Staff Time |
$78,681.57 |
Total |
$384,281.57 |
15. Explanation for Program Changes or Adjustments
This is a new emergency clearance request. Two rounds of RANDS during COVID-19 were approved under a separate emergency clearance (OMB No. 0920-1298, expiration: 11/30/2020). Before that, all previous rounds of RANDS have been conducted under CCQDER’s generic clearance (OMB No. 0920-0222, current expiration: 08/31/2021). The third round of RANDS during COVID-19 is being submitted as a new emergency ICR under the advice of NCHS’ OIRA desk officer and in order to conceptually link this work with other COVID-19-related emergency work from the Centers for Disease Control and Prevention.
This ICR is requesting a total of 1,734 burden hours.
16. Plans for Tabulation and Publication and Project Time Schedule
The following are key activities and projected completion dates for the third round of RANDS during COVID-19 project:
Activity |
Projected Completion Date |
Round 3 Survey Data Collection |
Three weeks after OMB approval |
Release of Round 3 Experimental Estimates |
7 weeks after OMB approval |
RANDS during COVID Data File Available |
Five months after OMB approval |
17. Reason(s) Display of OMB Expiration Date is Inappropriate
The expiration date will be displayed.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
The certifications are included in this submission.
1 https://www.cdc.gov/nchs/covid19/rands.htm
5 Parker, J, Miller, K, He, Y, Scanlon, P, Cai, B, Shin, H-C, Parsons, V, and K Irimata. 2020. “Overview and initial results of the National Center for Health Statistics’ Research and Development Survey.” Statistical Journal of the IAOS. 36(4): 1199-1211. doi: 10.3233/SJI-200678.
6 Scanlon, P. (2020). Using Targeted Embedded Probes to Quantify Cognitive Interviewing Findings. In Advances in Questionnaire Design, Development, Evaluation and Testing (eds P. Beatty, D. Collins, L. Kaye, J.L. Padilla, G. Willis and A. Wilmot). doi: 10.1002/9781119263685.ch17
7 To “monitor” means “to acquire, identify, or scan, or to possess, information that is stored on, processed by, or transiting an information system”; “information system” means “a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination or disposition of information;” “cyber threat indicator” means information that is necessary to describe or identify security vulnerabilities of an information system, enable the exploitation of a security vulnerability, or unauthorized remote access or use of an information system.
8 Procedures for submitting the proposal and other important information can be found here http://www.cdc.gov/rdc/
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Whitaker, Karen R. (CDC/DDPHSS/NCHS/DRM) |
| File Modified | 0000-00-00 |
| File Created | 2021-02-04 |