NIH is requesting a reinstatement without change to continue use the online Certificate of Confidentiality (CoC) application system for the next three years. In 2015, NIH launched an online application system for researchers to request a discretionary CoC from NIH. In 2020, NIH launched a new CoC online request system with fewer data fields than the 2015 system, to decrease 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. In 2022, NIH received OMB approval for the revision to the CoC system data fields to add an optional data field that allows the researcher to identify another person to receive CoC system communication and the approved CoC. Since then, there has been several non-substantial change memo requests to make minor updates to the system. For this request, NIH does not request any revisions and requests a reinstatement without change.
CoCs protect research participants by prohibiting disclosure of identifying information about participants to persons not connected to the research, with limited exceptions. NIH, through its funding Institutes, Centers, and Offices (ICOs), has issued CoC since 1997 to researchers who request this protection. Since 2016, NIH-funded researchers are deemed issued a Certificate upon award of NIH funding and do not need to request a Certificate through the system. Non-NIH funded researchers may continue to request a CoC through the online system.
US Code:
42 USC 241(d)
Name of Law: US Public Health Service Act
There is no revision included in this request. However, NIH received 865 requests for CoCs from January 2024 through December 2024, and NIH expects to receive approximately the same number of requests in subsequent years which is an increase of 70 respondents from our previous estimated figures.
$126,960
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.
Form 1 Form
30-day Comment Tracking Log_0925-0689_FINAL.docx
Public Comment_Certificates of Confidentiality Submission System.pdf
Private sector