View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0925-0667
ICR Reference No:
202110-0925-002
Status:
Historical Active
Previous ICR Reference No:
202102-0925-011
Agency/Subagency:
HHS/NIH
Agency Tracking No:
21290
Title:
NDAR Data Access Request (NIMH)
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
10/29/2021
Retrieve Notice of Action (NOA)
Date Received in OIRA:
10/21/2021
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/2024
01/31/2024
01/31/2024
Responses
1,250
0
1,250
Time Burden (Hours)
1,875
0
1,875
Cost Burden (Dollars)
0
0
0
Abstract:
The National Institute of Mental Health (NIMH) is requesting approval of the revised Data Submission Agreement (DSA) and Data Use Certification (DUC) information collection documents, which collect information about researchers submitting data and requesting access to shared data in the NIMH Data Archive (NDA). The NDA is an infrastructure for sharing human subjects research data and tools to further collaboration and scientific discovery.
Authorizing Statute(s):
US Code:
42 USC 203
Name of Law: Public Health Service Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
85 FR 36869
06/18/2020
30-day Notice:
Federal Register Citation:
Citation Date:
85 FR 65855
10/16/2020
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
NDA Data Submission Agreement (DSA)
1
NDA Data Submission Agreement
NDA Data Use Certification (DUC)
2, 2
NDA Data Use Certification
,
B NDA Data Use Certification revised clean 022421
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
1,250
1,250
0
0
0
0
Annual Time Burden (Hours)
1,875
1,875
0
0
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
To provide a segmentation of the research domains supported, we added a hyperlink leading to the current list of permission groups and their data access requirements on the DUC. Because the NDA requires one DUC for each request for access to a permission group, the DUC now includes fillable fields for the description, data use limitations, IRB approval, and institutional sponsorship for the chosen permission group. Additionally, the Data Use Terms and Conditions on the DUC have been updated. Specifically: new details have been added to the section titled “No Distribution of Data”; the section titled “Annual Update/Research Use Reporting” has been deleted; the section “Data Access for Research” has been deleted; and a new section, “Deletion of Data” has been added. Some sections have also been reordered or renamed, but the content of these sections has not been changed. Another change to the DUC concerns applications for renewal of an expiring DUC. The DUC section titled “4. Renewal Applicants Only” has been reordered and renamed to “2. Progress Updates (For Renewal Requests Only).” A new fillable field titled “Progress Report Statement” has been added to this section for renewal requestors to describe progress on research they have conducted using data from the NDA. Another overarching change relates to the requirements for accessing data. In the past all data access requests have required sponsorship by an Institution with an active FWA, which includes the signature of an institutional signing official. New research domains have been incorporated into the NDA that do not carry this level of requirement. A newly added Individual sponsorship does not require an active FWA or institutional business official signature but does still require the requestor to agree to the terms of data access. In both cases, new groups from which data are requested have been added to the DUC. The DSA has added the collection of additional grant related information that is targeted toward researchers not funded by the NIH who are requesting permission to submit data. Because the funding information is not accessible by NDA staff, the information is requested on the form.
Annual Cost to Federal Government:
$28,950
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?
No
Agency Contact:
Tawanda Abdelmouti 240 276-5530 ta401@nih.gov
Common Form ICR:
No
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:
10/21/2021
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