Supporting Statement A for
NCI Genomic Data Commons (GDC) Data Submission Request Form – Center for Cancer Genomics (CCG) (NCI)
OMB No. 0925-0752 Expiration Date 5/31/2020
This is an extension to the original submission and all changes are highlighted in yellow
Date: February 4, 2020
Check off which applies:
New
Revision
Reinstatement with Change
Reinstatement without Change
X Extension
Federal Government Employee Address:
Name: Zhining Wang
Address: Building 31 Room 3A20, 31 Center Drive, Bethesda, MD 20814
Telephone: 240.781.3404
Fax: N/A
Email: zhining.wang@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 – GDC Data Submission Request Form
Attachment 2 – PIA
Attachment 3 – Privacy Act Memo
Attachment 4 – Automated E-mail Response
A. Justification
This is a request for OMB to approve an extension for an additional three (3) years. The purpose of the NCI Genomic Data Commons (GDC) Data Submission Request Form is to provide a vehicle for investigators to request submission of their cancer genomic data into the GDC in support of data sharing. The purpose is to also provide a mechanism for the GDC Data Submission Review Committee to review and assess the data submission request for applicability to the GDC mission. The scope of the form involves obtaining information from investigators that: 1) would like to submit data about their study into the GDC, 2) are affiliated with studies that adhere to GDC data submission conditions. The benefits of the collection are that it provides the needed information for investigators to understand the types of studies and data that the GDC supports, and that it provides a standard mechanism for the GDC to assess incoming data submission requests.
A.1 Circumstances Making the Collection of Information Necessary
The GDC allows investigators to request data submission into the GDC in support of data sharing. The GDC follows the NIH Genomic Data Sharing policy (GDS) (https://gds.nih.gov/03policy2.html) which provides the administrative requirement for data sharing for all NIH-funded research (grants, contracts, intramural research). In order for the GDC to support the NIH GDS, The GDC must collect information from potential data submitters to understand their genomic data management needs so that the GDC can review their needs and decide on whether their needs can be supported.
The Public Health Law Title 42 of the United States Code provides the legal authority that allows the GDC to collection this information. NCI, established under the National Cancer Act of 1937, 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, to cancer patients, their families, physicians and other health professionals, and the general public, information on cancer research, diagnosis, prevention, and treatment (Sections 410 and 412 of the Public Health Service Act (42 USC § 285 and 285a-1)).
The purpose of the GDC Data Submission Request Form (Attachment 1) is to provide a mechanism in which investigators can request data submission for a study into the NCI GDC. Respondents of the form are Investigators interested in submitting data from their cancer genomic studies into the GDC. Investigators will navigate to the GDC Web Site, select a link to complete the GDC Data Submission Request Form, and submit the completed form. Information in the completed form will be routed to the GDC Support System and maintained in the Kayako Help Desk Software. The principal investigator will receive an automated e-mail message (Attachment 4) providing confirmation that the data submission request was received.
Once GDC Support receives the completed form, the information will be sent to the GDC Data Submission Review Committee composed of members of the NCI and GDC subcontractor team leads. The GDC Data Submission Review Committee reviews the information on the form and makes a decision as to whether: 1) The request should be approved, 2) The request should not be approved, 3) Additional information is required. GDC Support informs the investigator of the outcome of the review. For investigators whose studies are approved for GDC Data Submission, GDC Support works with the investigators to assist them with GDC data submission. Requests that are not approved may results in recommendations to support the study data in alternative repositories.
Without this form, the GDC will have difficulties in determining in a structured fashion whether the study is applicable to cancer genomics research and whether the GDC has the available resources to support the management of study data. The GDC is currently funded through May 19, 2018 and this form is needed throughout the course of the effort.
A.3 Use of Information Technology and Burden Reduction
The GDC Data Submission Request Form (Attachment 1) will be implemented as a Web-based form and made available on the existing GDC Web Site (https://gdc.cancer.gov) which uses the Drupal Content Management System (CMS). Use of existing GDC technologies will facilitate re-use and allow investigators to review information on the GDC, supported data types, and data submission policies prior to submitting a GDC Data Submission Request Form.
The NCI Privacy Act Coordinator was consulted, and it was determined that a Privacy Impact Assessment (PIA) is required. The PIA has been submitted to the NIH Privacy Act Coordinator for final approval and once received we will submit to OMB (Attachment 2).
The information that is being collected is unique to the GDC as it is structured around GDC data submission processes and is not found elsewhere in the government.
Small businesses or other small entities will not be impacted.
This is a one-time information collection.
There are no special circumstances related to the guidelines of 5 CFR 1320.5 in regards to the collection of information in the GDC Data Submission Request Form.
The 60-Day Federal Register Notice was published on December 2, 2019, Vol. 84 No. 231 , Page 65990 and allowed 60 days for public comment. No public comments were received.
No outside agency has been consulted
A.9 Explanation of Any Payment of Gift to Respondents
No incentives (neither payments nor gifts) will be distributed to individuals.
A.10 Assurance of Confidentiality Provided to Respondents
All information will be kept secure to the extent allowable by law. Information is collected in the Kayako Help Desk system located within the University of Chicago Data Center. The University of Chicago Data Center is FISMA Moderate compliant and operates as a Trusted Partner to the NCI. The Kayako Help Desk system is scanned on a regular basis to identify security vulnerabilities. Only designated GDC Support personnel and management have access to the Kayako Help Desk system. Information collected from the form will be reviewed by the GDC Data Submission Review Committee composed of NCI Senior Management and key members of the subcontracting team. Both GDC Support and members of the GDC Data Submission Review Committee will ensure that care is taken regarding the confidentiality of the respondents.
PII will be collected in the form of name and e-mail address of the principal investigator as well as any bioinformatician who will be assisting with data submission (Attachment 1). Once the principal investigator submits the form, an automated e-mail message will be sent to the e-mail that they providing confirming that the data submission request was received. (Attachment 4). The name and e-mail addresses will be used by the GDC Support Team in order to correspond with the principal investigator and bioinformatician regarding the outcome of the GDC’s decision on whether to approve or not approve the GDC Data Submission Request. The Privacy Act is applicable as determined by the NIH Privacy Officer in the Privacy Act Memo (Attachment 3). The applicable SORN is NIH Privacy Act Systems of Record 09-25-0156; “Records of Participants in Programs and Respondents in Surveys Used to Evaluate Programs of the Public Health Service, HHS/PHS/NIH/OD.”
A.11 Justification for Sensitive Questions
The GDC Data Submission Request Form contains no sensitive questions.
A.12.1 Estimates of Hour Burden Including Annualized Hourly Costs
The estimated annualized burden hours are 50. There are 200 investigators that will complete the form and it will take approximately 15 minutes for the respondent to complete the form (Table A.12-1).
Table A.12-1 Estimated Annualized Burden Hours
Form Name |
Type of Respondent |
Number of Respondents |
Number of Responses per Respondent |
Average Time Per Response (in hours) |
Total Annual Burden Hours |
GDC Data Submission Request Form (Attachment 1) |
Principal Investigator |
200 |
1 |
15/60 |
50 |
Total |
|
|
200 |
|
50 |
The estimated annualized costs to the respondents for completing the GDC Data Submission Request Form is $2,290.00 (Table A.12-2).
Table A.12-2 Annualized Cost to the Respondents
Form Name |
Type of Respondent |
Total Annual Burden Hour |
Hourly Respondent Wage Rate* |
Respondent Cost |
GDC Data Submission Request Form |
Principal Investigator |
50 |
$45.80 |
$2,290.00 |
Total |
|
50 |
|
$2,290.00 |
*The wage rate, $45.80, was calculated using the most recent data from Bureau of Labor Statistics for occupation code “19-1040” and occupation title “Medical Scientists”, 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 $20,078.68. The tasks performed by Federal Personnel include reviewing GDC Data Submission Request Forms, evaluating data submission requests against the requirements and resources available in the GDC, determining whether the Data Submission Request should be accepted or not accepted, 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 |
|
|
|
|
|
GDC Project Officer |
14/10 |
$ 157,709.00 |
2% |
|
$3,154.18 |
CCG Director |
SES |
$284,625.00 |
2% |
|
$5,692.50 |
TCGA Director |
15/10 |
$170,800.00 |
2% |
|
$3,416.00 |
OCG Director |
15/10 |
$170,800.00 |
2% |
|
$3,416.00 |
Travel |
|
|
|
|
$0 |
Other Cost |
|
|
|
|
$0 |
Operations and Maintenance |
|
|
|
|
$4,400.00 |
Total |
|
|
|
|
$20,078.68 |
** https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2020/DCB.pdf
A.15 Explanation for Program Changes or Adjustments
This is an extension of a currently approved submission. There are no substantive changes to this submission, however, the cost of federal employees decreased by ($20,046.16) due to computation errors. Additionally, the first-year cost ($3,400.00) is no longer needed in this extension, as such the total cost reduction is $23,627.86 ($43,359.70 - $19,731.84).
Results collected from the GDC Data Submission Request Form will not be published. Below is the list of activities and a timeline for making the GDC Data Submission Request Form available on the GDC Web Site.
A.16 - 1 Project Time Schedule |
|
Activity |
Time Schedule |
Data Submission Request Form available on the GDC Web Site |
1 week after OMB approval |
Completion of review of GDC data submission requests received from investigators |
2 weeks after investigator submits request |
A.17 Reason(s) Display of OMB Expiration Date is Inappropriate
The GDC Data Submission Request Form will display the OMB Expiration Date.
A.18 Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions for the GDC Data Submission Request Form.
| 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 | 2021-01-14 |