Supporting Statement A for
Generic Clearance for National Cancer Institute (NCI)
Resources, Software and Data Sharing Forms
OMB No. 0925-XXXX; Expiration Date xx/xx/20xx
Date: March 14, 2022
Check off which applies:
X New
Revision
Reinstatement with Change
Reinstatement without Change
Extension
Emergency
Existing Collection in Use Without an OMB Number
Federal Government Employee Address:
Name: Diane Kreinbrink
Address: 9609 Medical Center Drive, Rockville, MD 20850
Telephone: 240.276.7283
Email: Diane.Kreinbrink@nih.gov
Table of contents
A. JUSTIFICATION
A.1 Circumstances Making the Collection of Information Necessary
A.2. Purpose and Use of the Information COLLECTION
A.3 Use of Information Technology and Burden Reduction
A.4 Efforts to Identify Duplication and Use of Similar Information
A.5 Impact on Small Businesses or Other Small Entities
A.6 Consequences of Collecting the Information Less Frequently
A.7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
A.8 Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agency
A.9 Explanation of Any Payment of Gift to Respondents
A.10 Assurance of Confidentiality Provided to Respondents
A.11 Justification for Sensitive Questions
A.12 Estimates of Hour Burden Including Annualized Hourly Costs
A.13 Estimate of Other Total Annual Cost Burden to Respondents or Record keepers
A.14 Annualized Cost to the Federal Government
A.15 Explanation for Program Changes or Adjustments
A.16 Plans for Tabulation and Publication and Project Time Schedule
A.17 Reason(s) Display of OMB Expiration Date is Inappropriate
A.18 Exceptions to Certification for Paperwork Reduction Act Submissions
List of Attachments
Attachment 1 – Sub-Study Template Form
Attachment 2 – Privacy Act Memo
Attachment 3 – Data Submission Request Example
Justification
This is a new generic information collection request seeking approval for three years. The purpose of the “Generic for National Cancer Institute (NCI) Resources, Software and Data Sharing Forms” is to provide a cloud-based data science infrastructure to test ideas quickly, respond to the project’s needs as they evolve, incorporate feedback from scientists for flexible, innovative research methods, and provide a foundation for the cancer research community to make new scientific discoveries. The cloud-based infrastructure will connect data sets with analytical tools and access to online workspaces, tools, and NCI resources to support data sharing. Cloud-based data sharing, and analysis is only possible when requests, or applications, are made to access, upload, store, and analyze cancer data and metainformation.
A.1 Circumstances Making the Collection of Information Necessary
The NCI plans to co-locate data, storage, and computing infrastructure in the cloud with tools for analyzing and sharing data to create an interoperable resource for the research community. A shift in the location of the data has begun with the creation of the NCI Cancer Research Data Commons and the Childhood Cancer Data Initiative. These two separate resources will allow a multitude of different types of data (genomics, proteomics, imaging, clinical, population science, and other (e.g., flow cytometry, videos, etc.) to be submitted, stored, accessed, and managed by NCI. Data sharing allows data generated from one research study to be used to answer questions beyond the original study. It reinforces open scientific inquiry, encourages diversity of analysis, supports studies on data collection methods and measurement, facilitates the education of new researchers, and enables the exploration of topics not envisioned by the initial investigators. Biomedical researchers and data scientists can use the NCI cloud resources, web interface, and computational workspace to query, submit data, analyze, and visualize data.
The Public Health Law Title 42 of the United States Code provides the legal authority that allows the NCI to collect this information. NCI, was established under the National Cancer Act of 1937, and is the Federal Government's principal agency for cancer research and training and has a direct congressional mandate to disseminate information related to cancer to the public. The National Cancer Act of 1971 broadened the scope and responsibilities of the NCI and created the National Cancer Program. Over the years, legislative amendments have maintained the NCI authorities and responsibilities and added new information dissemination mandates as well as a requirement to assess the incorporation of state‑of‑the‑art cancer treatments into clinical practice. The Health Omnibus Programs Extension of 1988 (Public Law 100-607, Nov. 4, 1988, 102 Stat. 3048) and its amendments require the NCI to establish an information and education program to collect, identify, analyze, and disseminate on a timely basis, through publications and other appropriate means, information on cancer research, diagnosis, prevention, and treatment (Sections 410 and 412 of the Public Health Service Act (42 USC § 285 and 285a-1)).
To disseminate information and data, the National Institutes of Health (NIH) created the NIH Data Sharing Policy and Implementation Guidance (Final NIH Policy for Data Management and Sharing) which will require investigators to submit a data sharing plan beginning January 25, 2023 (https://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm). All data, particularly those generated through public funds, should be considered for data sharing. Furthermore, when the data are shared, they should be made as widely and freely available as possible while safeguarding the privacy of participants and protecting confidential and proprietary data. To facilitate data sharing for investigators, the NIH Data Sharing Policy applies to:
Sharing of final research data for research purposes, especially unique data that cannot be readily replicated
Basic research, clinical studies, surveys, and other types of research supported by NIH
Research that involves human subjects and laboratory research that does not involve human subjects
Applicants seeking $500,000 or more in direct costs in any year of the proposed project period through grants, cooperative agreements, or contracts
In preparation for dissemination and sharing of data sets, forms requesting or applying for access, upload, share, and store data will be needed. The purpose of data sharing allows data generated from one research study to be used to answer questions beyond the original study. It reinforces open scientific inquiry, encourages diversity of analysis, supports studies on data collection methods and measurement, facilitates the education of new researchers, and enables the exploration of topics not envisioned by the initial investigators. Biomedical researchers and data scientists can use the NCI cloud resources, web interface, and computational workspaces to query, submit data, analyze, and visualize data. The forms would be used to register a scientist’s research data, apply for data storage, and submit a request to access and use the data. In addition to these forms, forms related to metadata information (i.e., related to the collection of the research data; how the data was collected) would be collected for some research (Attachment 1).
Gathering information on the researcher and research project from which data will be submitted is important so that submitting researchers can be assisted throughout the multi-year process of data submission and to notify them of certain expectations for task completion based on data sharing terms. While NCI will define the conditions under which users can access and use data from the NCI Cancer Research Data Commons and the Childhood Cancer Data Initiative data repositories, this generic recognizes the shared need throughout NIH. Information on the proposed research questions or scientific research development will be needed by each respective IC committee within NIH to review and adjudicate data access requests. Requests that are not approved may result in recommendations to support the study data in alternative repositories.
Information on the forms may include a description of the research, how the data was collected, research tools, requestor’s credentials, proposed use of the data, and questions to assess whether the data are appropriate for sharing. The data catalogues and file repositories would cover various topics including molecular, cellular, social, and population-based sciences. In addition, ICs may ask questions related to the management and storage of the information so they can provide additional guidance, resources, and support for their respective studies. For NIH funded investigators, all requests would abide by the NIH Data Sharing Policy and Implementation Guidance.
While not inclusive, this is a sampling of the types of forms we anticipate:
Request Access to Use NCI Resources/Software
Project Renewal or Close-out Form
A.3 Use of Information Technology and Burden Reduction
NCI has developed The NCI Cancer Research Data Commons (CRDC), a cloud-based data science infrastructure that connects data sets with analytics tools to allow users to share, integrate, analyze, and visualize cancer research data to drive scientific discovery. This cloud-based data science infrastructure connects data sets/repositories with analytical tools. This online system was developed to register studies, submit data, and request access to data. Using an online system allows investigators to submit the required information directly, thereby minimizing burden not only for investigators and institutions, but also for NIH staff. The online system uses time-saving features, such as the use of pull-down and scrolling menus to fill data fields, “find as you type” (or “type ahead”) functionality, and text fields that allow investigators and requesters to cut and paste information from other sources.
The NCI Privacy Act Coordinator was consulted, and it was determined that a Privacy Impact Assessment (PIA) will be required when personally identifiable information is being uploaded, stored, or accessed. For each sub-study requiring a PIA, a copy of the PIA that has been submitted to the NIH Privacy Act Coordinator will be included in the submission.
The change request approved by OMB on 9/28/2021 for the Generic Clearance for NIH Citizen Science and Crowdsourcing Projects (NIH) (OMB No. 0925-0766, Expiration Date 4/30/2023) allows for submitting applications and forms to access data. NCI proposal goes beyond requests to access data to includes forms for uploading, submitting, storing, and sharing data and access to data-related tools such as workspaces and analytic tools and software.
No small businesses or other small entities will not be impacted.
Following the initial request and approval to use controlled-access data, some requesters must provide annual updates on their research progress and renew access to the dataset(s) for another year or close-out access to the dataset(s). The consequence of not submitting the required information annually is a reduction in NIH oversight in the use of data, possibly leading to an increased rate of adverse data management incidents.
This collection fully complies with 5 CFR 1320.5.
The 60-Day Federal Register Notice was published on December 20, 2021, Vol, 86, Page 71901 and allowed 60 days for public comment. No public comments were received.
We have not consulted with any outside agency on this project.
A.9 Explanation of Any Payment of Gift to Respondents
No incentives (neither payments nor gifts) will be distributed to individuals or institutions.
A.10 Assurance of Confidentiality Provided to Respondents
Prior to sharing, data should be redacted to strip all identifiers, and effective strategies should be adopted to minimize risks of unauthorized disclosure of personal identifiers. Stripping a dataset of items that could identify individual participants is referred to by several different terms, such as "data redaction," "de-identification of data," and anonymizing data. In addition to removing direct identifiers, e.g., name, address, telephone numbers, and Social Security Numbers, researchers should consider removing indirect identifiers and other information that could lead to "deductive disclosure" of participants' identities. Deductive disclosure of individual subjects becomes more likely when there are unusual characteristics of the joint occurrence of several unusual variables. Samples drawn from small geographic areas, rare populations, and linked datasets can present challenges to the protection of subjects' identities.
Investigators may use different methods to reduce the risk of subject identification. One possible approach is to withhold some part of the data. Alternatively, an investigator may restrict access to the data at a controlled site, sometimes referred to as a data enclave. Some investigators may employ hybrid methods, such as releasing a highly redacted dataset for general use but providing access to more sensitive data with stricter controls through a data enclave.
Researchers who seek access to individual level data are typically required to enter into a data-sharing agreement. Data-sharing agreements, which come by many terms, including "license agreements," and "data distribution agreements," generally include requirements to protect participants' privacy and data confidentiality. They may prohibit the recipient from transferring the data to other users or require that the data be used for research purposes only, among other provisions, and they may stipulate penalties for violations.
For access to and submission of data, researchers are both NIH-funded and non-NIH-funded investigators. Making these researcher’s names available is an important ethical underpinning of the NIH GDS Policy as it allows NIH to be transparent in informing research participants, the scientific community, and the public on how data are being shared, with whom, and for what research purpose in addition to fostering future research collaborations.
The names and institutional affiliations of the researchers (both data submitters and data requesters) may be posted publicly on a website, and thus there is no assurance of confidentiality afforded to the researchers. However, it is important to emphasize that no personal information is requested from researchers submitting or accessing data beyond their name and institutional affiliation. Data submitters are largely NIH-funded investigators whose names and institutional affiliations are already a matter of public record. All information will be kept secure to the extent allowable by law.
The Privacy Act is applicable as determined by the NIH Privacy Officer in the Privacy Act Memo (Attachment 2). This data collection is covered by the following Privacy Act System of Records:
09-25-0200, “Clinical, Basic and Population-based Research Studies of the National Institutes of Health (NIH), HHS/NIH/OD.”
09-25-0036, “Extramural Awards and Chartered Advisory Committees (IMPAC 2)”
09-90-1401, “Records About Restricted Dataset Requesters”
A.11 Justification for Sensitive Questions
No questions of a sensitive nature are included in this data collection.
A.12.1 Estimates of Hour Burden Including Annualized Hourly Costs
The total estimated annualized burden hours are: 5,775 and the number of responses per respondent is estimated at 13,500 (Table A.12-1). The burden hours for the requested 3 years will be 17,325 with 40,500 responses.
Table A.12-1 Estimated Annualized Burden Hours
Form Name |
Type of Respondents |
Number of Respondents |
Number of Responses per Respondent |
Average Burden Per Response (in hours) |
Total Annual Burden Hours |
Request Data Access/Use |
|||||
Data Access Request -Submitter |
Individuals |
1,500 |
1 |
45/60 |
1,125 |
Institutional Certification |
Individuals |
1,500 |
1 |
30/60 |
750 |
Data Submission/Storage |
|||||
Data Submission/ Storage Request |
Individuals |
1,500 |
1 |
30/60 |
750 |
Institutional Certification |
Individuals |
1,500 |
1 |
30/60 |
750 |
Request Access to/Use NCI Resources/Software |
|||||
Data Resources |
Individuals |
1,500 |
1 |
30/60 |
750 |
Project Renewal or Project Close-out |
|||||
Project Renewal or Project Close-out form |
Individuals |
1,500 |
2 |
15/60 |
750 |
Institutional Certification |
Individuals |
1,500 |
2 |
18/60 |
900 |
Totals |
|
10,500 |
13,500 |
|
5,775 |
A.12-2 Annualized Cost to respondents
The total estimated annual cost to respondents is $290,550.75. Table A12-1 illustrates the measures respondents will be answering and the number of hours to complete each type (Table A.12-2).
Table A.12-2 Annualized Cost to the Respondents
Type of Respondents |
Total Annual Burden Hours |
Hourly Respondent Wage Rate* |
Respondent Cost |
Request Data Access/Use |
|||
Individuals - Submitter |
1,125 |
$48.45 |
$54,506.25 |
Individuals - Institutional Official |
750 |
$52.93 |
$39,697.50 |
Data Submission/Storage |
|||
Individuals - Submitter |
750 |
$48.45 |
$36,337.50 |
Individuals - Institutional Official |
750 |
$52.93 |
$39,697.50 |
Request Access to/Use NCI Resources/Software |
|||
Data Resources |
750 |
$48.45 |
$36,337.50 |
Project Renewal/Project Close-out Process |
|||
Individual - Submitter |
750 |
$48.45 |
$36,337.50 |
Individuals - Institutional Official |
900 |
$52.93 |
$47,637.00 |
Total |
|
|
$290,550.75 |
*The median wage rate was calculated using the most recent data from Bureau of Labor Statistics for occupation code “19-1040” occupation title “Medical Scientists”, rate of $48.45 and Occupation Code “19-2099” occupation title “Physical Scientists, All Other”, rate of $52.93, https://www.bls.gov/oes/current/oes_nat.htm.
A.13 Estimate of Other Total Annual Cost Burden to Respondents or Record Keepers
There are no other costs to respondents other than their time.
The annualized cost to the Federal Government for the collection of data is $16,900.54. The tasks performed by Federal Personnel include reviewing the data submission, access/use, storage, and resources request forms, evaluating the requests against the requirements and resources available, determining whether the request should be accepted or not, and overseeing the contractors.
Table 14.1 Annualized Cost to the Federal Government
Staff |
Grade/Step |
Salary** |
% of Effort |
Fringe (if applicable) |
Total Cost to Gov’t |
Federal Oversight |
|
|
|
|
|
Project Officer |
14/10 |
$164,102 |
2% |
|
$3,282.04 |
Director |
SES |
$284,625 |
2% |
|
$5,692.50 |
Program Director |
15/10 |
$176,300 |
2% |
|
$3,526.00 |
Contractor Cost |
|
|
|
|
$4,400.00 |
Travel |
|
|
|
|
$0 |
Other Cost |
|
|
|
|
$0 |
Total |
|
|
|
|
$16,900 |
**The Salary in the table above is cited from https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/22Tables/html/DCB.aspx
A.15 Explanation for Program Changes or Adjustments
This is a new generic information collection.
There are no plans for tabulation or publication for the information submitted on the requests.
Below is the list of activities and a timeline.
A.16 - 1 Project Time Schedule |
|
Activity |
Time Schedule |
Data request forms available |
1 week after OMB approval |
Completion of review and response to forms |
2-3 weeks after investigator submits request |
A.17 Reason(s) Display of OMB Expiration Date is Inappropriate
We are not requesting exemption from the display of the OMB expiration date.
A.18 Exceptions to Certification for Paperwork Reduction Act Submissions
This information collection will comply with the requirements in 5 CFR 1320.9.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Subject | Supporting Statement A |
| Author | Lopez, Maria (NIH/NICHD) [E] |
| File Modified | 0000-00-00 |
| File Created | 2022-03-17 |