No
material or nonsubstantive change to a currently approved
collection
No
Regular
10/21/2021
Requested
Previously Approved
01/31/2024
01/31/2024
1,250
1,250
1,875
1,875
0
0
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.
US Code:
42
USC 203 Name of Law: Public Health Service Act
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.
$28,950
No
Yes
Yes
No
No
No
No
Tawanda Abdelmouti 240 276-5530
ta401@nih.gov
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:
(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;
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.
Form 2 NDA Data Use Certification (DUC)
Attachment A_Revised tracked changes copy of NDA Data Submission Agreement.docx
pub 30-day FRN2020-22932.pdf
NDA Data Use Certification (DUC)