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

Forms and Documents

Document Name	Status
Form 1 Private sector Form	Modified
30day FRN.pdf Supplementary Document	2025-07-08
NIH CoC Support Statement A.docx Supporting Statement A	2025-07-07
Attachment 2 - List of DHHS CoC Coordinators.docx Supplementary Document	2025-07-07
Attachment 4 - NIH Privacy Act Memo Applicability of the Privacy Act_CoC_FEB 2022.pdf Supplementary Document	2025-07-07
Attachment 3 - Privacy Impact Assessment (PIA).pdf Supplementary Document	2025-07-07

IC Document Collections

IC ID	Document Title	Status
252166	Private sector Form	Modified

ICR Details

OMB Control No: 0925-0689	ICR Reference No: 202507-0925-001
Status: Received in OIRA	Previous ICR Reference No: 202411-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No: 20936
Title: Electronic Application for NIH Certificates of Confidentiality (CoC E-application System)
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/08/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	865	0
Time Burden (Hours)	1,298	0
Cost Burden (Dollars)	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 42 USC 241(d) Name of Law: US Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 15989	04/16/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 30073	07/08/2025
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Private sector	1, 1	Application ,   Form

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ICR Summary of Burden

	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	865	0	0	865	0	0
Annual Time Burden (Hours)	1,298	0	0	1,298	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $126,960

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

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Common Form ICR:  No

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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: 07/08/2025

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