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

Forms and Documents

Document Name	Status
Form 1 Private sector Form and Instruction	Unchanged
Revised assurance statement SEP2023.clean.docx Supplementary Document	2023-10-05
Markup assurance statement SEP2023.pdf Supplementary Document	2023-10-05
OMB change request SEP 2023.1signed.pdf Justification for No Material/Nonsubstantive Change	2023-10-04
Updated assurance statement 06022023.pdf Supplementary Document	2023-06-15
OMB change request JUN 2023.pk.pdf Justification for No Material/Nonsubstantive Change	2023-06-15
Change Request Memo.docx Justification for No Material/Nonsubstantive Change	2022-10-13
pub 30day FRN2022-05474.pdf Supplementary Document	2022-03-15
Attachment 2 - List of DHHS CoC Coordinators.docx Supplementary Document	2022-03-14
CoC Support_StatementA_FINAL_MAR2022.docx Supporting Statement A	2022-03-14
Attachment 3 - Privacy Impact Assessment (PIA) NOV 2021.pdf Supplementary Document	2022-03-14
Attachment 4 - NIH Privacy Act Memo Applicability of the Privacy Act_CoC_FEB 2022.pdf Supplementary Document	2022-03-14

IC Document Collections

IC ID	Document Title	Status
252166	Private sector Form and Instruction	Unchanged

ICR Details

OMB Control No: 0925-0689	ICR Reference No: 202310-0925-001
Status: Received in OIRA	Previous ICR Reference No: 202306-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No: 20936
Title: Electronic Application for NIH Certificates of Confidentiality (CoC E-application System)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/05/2023

	Requested	Previously Approved
Expiration Date	04/30/2025	04/30/2025
Responses	795	795
Time Burden (Hours)	1,193	1,193
Cost Burden (Dollars)	0	0

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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.

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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:
	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

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

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

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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	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

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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

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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: 10/05/2023

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