NIH Information Collection Forms to Support Genomic Data Sharing for Research Purposes (OD)

Forms and Documents

Document Name	Status
Form 2 Project Renewal or Project Close-out Official to Certify Request Form and Instruction	New
Form 2 Project Renewal or Project Close-out Requester Submitting Request Form and Instruction	New
Form 2 Requesting Access to Data Signing Official to Certify Request Form and Instruction	New
Form 2 Data Access Request Form and Instruction	New
Form 1 Institutional Certification Form and Instruction	New
Form 1 Study Registration and Data Submission Form and Instruction	New
Form 2 Renewal/project Close-out process Signing Official to Certify Request Form and Instruction	Removed
Form 2 Renewal/Project Close-out process Investigator Requesting Data Form and Instruction	Removed
Form 2 Requesting Access to Data Signing Official to Certify Request Form and Instruction	Removed
Form 2 Requesting Access to Data Investigator Requesting Data Form and Instruction	Removed
Form 1 Study Registration and Data Submission Institutional Official to Certify Submission Form and Instruction	Removed
Form 1 Study Registration and Data Submission Form and Instruction	Removed
30-day FRN2019-16289.pdf Supplementary Document	2019-07-31
Attachment 4 - 06_1 HHS Privacy Impact Assessment-NIH NLM dbGaP Database of Genotype an.pdf Supplementary Document	2019-07-19
Attachment 3 - Supplementary Document - dbGaP Registration Notification Email.docx Supplementary Document	2019-07-19
GDS PRA SSA Final.docx Supporting Statement A	2019-07-19

IC Document Collections

IC ID	Document Title	Status
236992	Project Renewal or Project Close-out Official to Certify Request Form and Instruction	New
236991	Project Renewal or Project Close-out Requester Submitting Request Form and Instruction	New
236987	Requesting Access to Data Signing Official to Certify Request Form and Instruction	New
236986	Data Access Request Form and Instruction	New
236985	Institutional Certification Form and Instruction	New
236984	Study Registration and Data Submission Form and Instruction	New
220221	Renewal/project Close-out process Signing Official to Certify Request Form and Instruction	Removed
220220	Renewal/Project Close-out process Investigator Requesting Data Form and Instruction	Removed
220219	Requesting Access to Data Signing Official to Certify Request Form and Instruction	Removed
220218	Requesting Access to Data Investigator Requesting Data Form and Instruction	Removed
220217	Study Registration and Data Submission Institutional Official to Certify Submission Form and Instruction	Removed
205637	Study Registration and Data Submission Form and Instruction	Removed

ICR Details

OMB Control No: 0925-0670	ICR Reference No: 201907-0925-004
Status: Active	Previous ICR Reference No: 201602-0925-015
Agency/Subagency: HHS/NIH	Agency Tracking No: 18667
Title: NIH Information Collection Forms to Support Genomic Data Sharing for Research Purposes (OD)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/15/2019
	Date Received in OIRA: 07/31/2019
Terms of Clearance: OMB is approving this information collection request for a period of three years during which time the agency will request approval to extend or revise the collection if the agency seeks to continue the information collection activity beyond the period approved under this action.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2022	36 Months From Approved	11/30/2019
Responses	12,600	0	5,364
Time Burden (Hours)	5,850	0	2,505
Cost Burden (Dollars)	0	0	0

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Abstract: Sharing of research data is an integral element of the mission of the National Institutes of Health (NIH), as it advances our understanding of factors that influence health and disease, while also providing opportunities to accelerate research through the power of combining large and information-rich datasets. To promote robust sharing of human and non-human genomic data from a wide range of large-scale genomic research, and to provide appropriate protections for research involving human data, the NIH issued the NIH Genomic Data Sharing Policy (GDS Policy). The GDS Policy, an extension of the 2008 NIH Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (the GWAS Policy), applies to all NIH-funded research that generates large-scale human or non-human genomic data as well as the use of these data for subsequent research.

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Authorizing Statute(s): US Code: 42 USC 241 sect. 301 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 18555	05/01/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 37324	07/31/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Study Registration and Data Submission Institutional Official to Certify Submission	1	Attachment 1 Documentation of the dbGaP registration system
Requesting Access to Data Investigator Requesting Data	2	Attachment 2 Documentation of the dbGaP access system
Study Registration and Data Submission	1	Online dbGaP Registration and Submission Forms
Project Renewal or Project Close-out Requester Submitting Request	2	Online dbGaP Data Access Request Forms
Renewal/project Close-out process Signing Official to Certify Request	2	Attachment 2 Documentation of the dbGaP access system
Project Renewal or Project Close-out Official to Certify Request	2	Online dbGaP Data Access Request Forms
Study Registration and Data Submission	1	Attachment 1 Documentation of the dbGaP Registration system
Requesting Access to Data Signing Official to Certify Request	2	Attachment 2 Documentation of the dbGaP access system
Institutional Certification	1	Online dbGaP Registration and Submission Form
Data Access Request	2	online dbGaP Data Access Request Forms
Renewal/Project Close-out process Investigator Requesting Data	2	Attachment 2 Documentation of the dbGaP access system
Requesting Access to Data Signing Official to Certify Request	2	Online dbGaP Data Access Request Forms

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	12,600	5,364	0	7,236	0	0
Annual Time Burden (Hours)	5,850	2,505	0	3,345	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This application is for a revision to an existing Office of Management and Budget (OMB) approved collection of information, 0925-0670. Changes in Attachments 1 and 2 are described below and noted in red boxes in the attachments. Some changes focus on reducing redundancy among data submissions and access requests and increasing awareness of the ethical responsibilities associated with the responsible use of genomic information. In the dbGaP registration and submission forms (Attachment 1): additional questions on publication embargo deleted because this is no longer applicable (slide 4), added ability for investigator to add additional investigators that are notified when a submitted dataset is used (slide 4), added ability to review previously entered submission information for accuracy (slide 4), added ability to auto-create the DUC from existing information in the submission package (slide 5), added ability to auto-create the DUC from existing information in the submission package (slide 6), added a column for “Collaborating Site” that automatically adds additional rows to form when information is entered for all rows and columns (slide 7), and created new ability for investigators and Institutional Officials to digitally sign form (slide 8). In the dbGaP data access, renewal, and close-out forms (Attachment 2): information on the login page have been reorganized and consolidated to make the application information more apparent and prominent (slide 3), a pop-up reminder has been added to the “create decryption password” field to alert requester additional information is needed (slide 7), the “Research Plans with Approved Dataset(s)” field has been removed as it is redundant with information provided in the “Research Progress” and “Research Plans with Approved Datasets” sections (slide 22)

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Annual Cost to Federal Government: $4,996,900

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 07/31/2019

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