Electronic Application for NIH Certificates of Confidentiality (CoC E-application System)

ICR 202310-0925-001

OMB: 0925-0689

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Unchanged
Supplementary Document
2023-10-05
Supplementary Document
2023-10-05
Justification for No Material/Nonsubstantive Change
2023-10-04
Supplementary Document
2023-06-15
Justification for No Material/Nonsubstantive Change
2023-06-15
Justification for No Material/Nonsubstantive Change
2022-10-13
Supplementary Document
2022-03-15
Supplementary Document
2022-03-14
Supporting Statement A
2022-03-14
Supplementary Document
2022-03-14
Supplementary Document
2022-03-14
IC Document Collections
IC ID
Document
Title
Status
252166 Unchanged
ICR Details
0925-0689 202310-0925-001
Received in OIRA 202306-0925-002
HHS/NIH 20936
Electronic Application for NIH Certificates of Confidentiality (CoC E-application System)
No material or nonsubstantive change to a currently approved collection   No
Regular 10/05/2023
  Requested Previously Approved
04/30/2025 04/30/2025
795 795
1,193 1,193
0 0

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.

US Code: 42 USC 241(d) Name of Law: US Public Health Service Act
  
None

Not associated with rulemaking

  86 FR 71650 12/17/2021
87 FR 14545 03/15/2022
No

1
IC Title Form No. Form Name
Private sector 1 Certification of Confidentiality

  Total Request 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
No
No
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

$82,747
No
    Yes
    Yes
No
No
No
No
Mikia Currie 3014350941

  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.
10/05/2023


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