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:
0925-0689
ICR Reference No:
202210-0925-006
Status:
Historical Active
Previous ICR Reference No:
202203-0925-001
Agency/Subagency:
HHS/NIH
Agency Tracking No:
20936
Title:
Electronic Application for NIH Certificates of Confidentiality (CoC E-application System)
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:
10/17/2022
Retrieve Notice of Action (NOA)
Date Received in OIRA:
10/13/2022
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
04/30/2025
04/30/2025
04/30/2025
Responses
795
0
795
Time Burden (Hours)
1,193
0
1,193
Cost Burden (Dollars)
0
0
0
Abstract:
NIH is requesting a revision for three years. In 2015, NIH launched an online application system for researchers to request a Certificate of Confidentiality (CoC) from NIH. In 2020, NIH launched a new CoC online request system with fewer data fields than the 2015 system, to decrease the burden on the requester and NIH staff. Information is collected to allow confirmation of eligibility for a CoC and to issue a Certificate. Eligible requesters receive an electronic Certificate once approved. The revision to the CoC system data fields is to add an optional data field that allows the researcher to identify another person to receive CoC system communication and the approved CoC. Currently, there are two persons for which we request an email address (the Principal Investigator and the Institutional Official); these persons receive CoC system communications and the approved CoC.
Authorizing Statute(s):
US Code:
42 USC 241(d)
Name of Law: US 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:
86 FR 71650
12/17/2021
30-day Notice:
Federal Register Citation:
Citation Date:
87 FR 14545
03/15/2022
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Private sector
1
Certification of Confidentiality
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
795
795
0
0
0
0
Annual Time Burden (Hours)
1,193
1,193
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:
The proposed revision of adding an optional data field that allows the researcher to identify another person to receive CoC system communications and the approved CoC is addressing a request from multiple researchers and will reduce the administrative burden to researchers associated with maintaining their CoC. NIH received 795 requests for CoCs from January 2020 through December 2020, which is a difference of 266 more requests from what was previously approved by OMB; NIH expects to receive approximately the same number of requests in subsequent years
Annual Cost to Federal Government:
$82,747
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:
10/13/2022
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